TWI669111B - Drug solution-storing package and drug solution-storing container - Google Patents

Abstract

The main object of the present invention is to provide a medicinal solution storage bag having a multiple structure of an inner bag capable of suppressing the elution of impurities into the medicinal solution.

The medicinal solution storage packaging bag of the present invention includes a bag body having an inner bag composed of an inner layer film and an outer bag composed of an outer layer film; and an injection member; the inner bag and the outer bag are provided to overlap the above The multilayer structure formed by the inner layer film and the outer layer film is a heat-sealed portion which is welded in a state where the inner layer films face each other and overlap. The inner layer film has a melting point of 230 on the outermost surface of the chemical liquid side. For a fluorine-containing resin film below ℃, the outer layer film is a laminated film having a first outer layer film and a second outer layer film, and the first outer layer film is disposed on the inner bag side and can be thermally welded with the inner layer film. The film for heat-welding, and the second outer layer film is a film disposed on the outer side of the bag body and containing a resin having a melting point equal to or higher than the melting point of the fluorine-containing resin of the inner layer film.

Description

Packaging bag for medicinal solution storage and container for medicinal solution storage

The present invention relates to a medicinal solution storage packaging bag having a multiple structure of an inner bag capable of suppressing the elution of impurities into the medicinal solution and a medicinal solution storage container using the same.

When storing, transporting, and other medicinal liquids used in the fields of industrial medicine, pharmaceuticals, and cosmetic raw materials, medical liquid storage containers such as metal cans have been used. It is conventionally known that the medicinal solution is directly filled in the medicinal solution storage container, so there is a concern that impurities such as particles existing inside the medicinal solution storage container may affect the medicinal solution. In addition, in order to remove the impurities, it is necessary to clean the inside of the medicinal solution storage container at a higher level, and there is a problem that the cost of reusing the medicinal solution storage container becomes high. In addition, depending on the type of the medicinal solution, there is a problem that the inside of the medicinal solution storage container itself deteriorates. In addition, in these medicinal solution storage containers, the medicinal solution is taken out from the injection port by feeding nitrogen into the medicinal solution storage container to apply pressure, but in this case, the nitrogen comes into contact with the medicinal solution. There are problems such as a change in the viscosity of the chemical liquid due to the influence of nitrogen, etc., or a change in the composition of the chemical liquid.

In response to these problems, for example, as shown in Patent Documents 1 to 5, it has been proposed to use a medicinal solution storage container in a medicinal solution storage container and to arrange the medicinal solution storage bag inside the body. When a packaging bag for storing a chemical solution is used, it is possible to suppress the time required for washing, etc., or the deterioration of the inside of the body of the container for storing a chemical solution. In the case where the medicinal solution is taken out from the inside of the medicinal solution storage container, nitrogen gas or the like is fed into the main body to thereby The medicine liquid can be taken out by applying pressure from the outside of the medicine liquid storage bag. Therefore, it is possible to prevent the composition, viscosity, etc. of the medicinal solution from being changed due to the contact between the nitrogen and the medicinal solution.

As such a packaging bag for storing a medicinal solution, for example, as shown in Patent Documents 4 and 5, a double structure having an inner bag for storing a medicinal solution and an outer bag for covering the inner bag is proposed. The packaging bag for medicinal solution storage having a double structure has the following structure: the inner bag and the outer bag are each formed of a resin film, and have the following heat-sealed portions, and the inner and outer bags are integrated in the heat-sealed portion; the heat-sealed portion A multilayer structure is formed by overlapping a resin film (hereinafter, sometimes referred to as an inner layer film) constituting an inner bag and a resin film (hereinafter, sometimes referred to as an outer layer film) constituting an outer bag so as to overlap The inner layer films are configured by heat-welding so that they face each other. In the case where the packaging bag for medicinal solution storage has a double structure, impact resistance and gas barrier properties can be improved.

Further, in the packaging bag for medicinal solution storage of the above-mentioned dual structure, in order to improve the adhesion between the inner layer film and the outer layer film at the heat-sealed portion, it is preferable to use a polyolefin resin or the like for the inner layer film and the outer layer film. Laminated film of a film of a resin having thermal fusion properties.

Moreover, in the packaging bag for storing a medicinal solution, the inner part of the inner bag is in direct contact with the medicinal solution. Therefore, as an inner layer film constituting the inner bag, for example, the incorporation of impurities into the medicinal solution and the elution of the impurities into the medicinal solution are suppressed. From the viewpoint, it is proposed to use a polyolefin without addition. However, in recent years, the use of various medicinal liquids for packaging bags for storing medicinal liquids has been increasing, and as inner bags, those having lower dissolution of impurities into the medicinal liquid are expected.

[Prior technical literature] [Patent Literature]

[Patent Document 1] Japanese Patent Laid-Open No. 9-95565

[Patent Document 2] Japanese Patent Publication No. Hei 5-505372

[Patent Document 3] Japanese Patent Publication No. 2009-539706

[Patent Document 4] Japanese Patent No. 4920678

[Patent Document 5] Japanese Patent No. 5008908

[Non-patent literature]

[Non-Patent Document 1] Hongxiang Teng, "Overview of the Development of the Fluoropolymer Industry", Appl. Sci. 2012, 2, 496-512; doi: 10. 3390 / app2020496

The present invention has been made in view of the above-mentioned circumstances, and a main object thereof is to provide a medicinal solution storage packaging bag having a multiple structure of an inner bag capable of suppressing the elution of impurities into the medicinal solution, and a medicinal solution storage container using the same.

In order to achieve the above object, the present invention provides a packaging bag for storing a medicinal solution, which comprises an inner bag comprising an inner layer film and containing the medicinal solution, and an outer bag consisting of an outer layer film and disposed outside the inner bag. The bag body and the injection member connected to the bag body are characterized in that the inner bag and the outer bag have a multilayer structure in which the inner layer film and the outer layer film are stacked so that the inner layer film faces each other. In the overlapped state, it is a heat-sealed part. The inner layer film has a film containing a fluorine-containing resin having a melting point of 230 ° C. or lower on the outermost surface of the chemical solution side, and the outer layer film has a A laminated film of a first outer layer film and a second outer layer film disposed on the outer side of the bag body. The first outer layer film can be thermally welded to the inner layer film. The film for thermal welding, and the second outer layer film is a film having a resin having a melting point equal to or higher than the melting point of the fluorine-containing resin of the inner layer film.

According to the present invention, the inner layer film has a film containing a fluorine-containing resin, and the outer layer film has a film for heat fusion, whereby a packaging bag having a multiple structure with an inner bag capable of suppressing the elution of impurities into the medicinal solution can be produced.

In the above invention, the inner layer film may include only the film containing the fluorine-containing resin, and the film for thermal fusion in the first outer layer film may be a film containing a fluorine-containing resin having a melting point of 230 ° C or lower. Since the inner layer film contains only a film containing a fluorine-containing resin, the elution of impurities into the medicinal solution can be more effectively suppressed.

In the above invention, it is preferable that the bag body further includes an intermediate bag disposed between the inner bag and the outer bag and composed of an intermediate film, and the multilayer structure in the heat-sealed portion has the inner layer film and the intermediate layer superposed thereon. A film and the outer layer film, and the intermediate film has a film containing a fluorine-containing resin having a melting point of 230 ° C. or lower. The strength of the packaging bag for storing the medicinal solution of the present invention can be increased.

In the above invention, the inner layer film may be a first inner layer film having a fluorine-containing resin disposed on the side of the chemical solution and containing a melting point of 230 ° C. or lower, and disposed on the outer bag side and including The laminated film of the second inner layer film of the resin having the same melting point as that of the above-mentioned fluororesin, or a heat-sealed resin at a temperature lower than or equal to the above, and the above-mentioned outer-layer film, the above-mentioned film for heat-sealing is included in A film of a resin that is heat-sealed at or below a temperature. Since the inner layer film has a second inner layer film, the thickness and material of the second inner layer film can be selected to adjust the strength of the inner bag. Therefore, even when the thickness of the first inner layer film is reduced, the strength of the inner bag can be ensured, and the use amount of the relatively expensive fluororesin can be reduced to make a low-cost packaging bag. In addition, the material of the outer layer film can be selected in a wide range.

In the above invention, it is preferable that the bag body further includes an intermediate bag disposed between the inner bag and the outer bag and composed of an intermediate film, and the multilayer structure in the heat-sealed portion has the inner layer film and the intermediate layer superposed thereon. The structure of the film and the outer layer film, and the intermediate film includes a resin that can be thermally welded at a temperature equal to or lower than the melting point of the fluororesin. The strength of the packaging bag of the present invention can be increased.

The present invention provides a container for storing a medicinal solution, which comprises an outer container and a packing bag for storing a medicinal solution arranged in the outer container, characterized in that the packing bag for storing a medicinal solution includes a bag body having: An inner bag composed of an inner layer film and containing a medicinal solution, and an outer bag composed of an outer layer film and disposed outside the inner bag; and an ejection member that is connected to the bag body; the inner bag and the outer bag have The multi-layered structure in which the inner layer film and the outer layer film are overlapped is a heat-sealed portion which is welded in a state where the inner layer films overlap with each other, and the inner layer film has a melting point on the outermost surface of the chemical liquid side. The film is a fluorine-containing resin of 230 ° C or lower. The outer layer film is a laminated film including a first outer layer film disposed on the inner bag side and a second outer layer film disposed on the outer side of the bag body. The first outer layer is The film is a film for heat fusion that can be thermally welded to the inner layer film, and the second outer layer film includes a resin having a melting point equal to or higher than the melting point of the fluorine-containing resin of the inner layer film.

According to the present invention, the medicinal solution storage packaging bag can be used as a medicinal solution storage container capable of suppressing the dissolution of impurities from the inner bag in the medicinal solution storage bag into the medicinal solution.

The packaging bag for storing a medicinal solution according to the present invention has the following functions and effects: it has a multiple structure having an inner bag capable of suppressing the elution of impurities into the medicinal solution.

1‧‧‧ Medicinal liquid storage packaging bag (packaging bag)

2‧‧‧ bag body

3‧‧‧Injecting components

4‧‧‧ container for medicinal solution storage

5‧‧‧ Outer container

21‧‧‧Inner bag

21a‧‧‧Inner film

22‧‧‧ Outer bag

22a‧‧‧outer film

23‧‧‧Heat Welding Department

23X‧‧‧Heat welding surface

24‧‧‧ Middle Bag

24a‧‧‧Interlayer

31‧‧‧Note outlet joint

32‧‧‧Note outlet installation department

33‧‧‧ middle pillar

34‧‧‧ opening

35‧‧‧note outlet body

36‧‧‧ bottom mounting ring

51‧‧‧ container body

52‧‧‧Gas Supply Department

53‧‧‧Fixed section

61, 62‧‧‧ Nozzles

211‧‧‧The first inner layer film

212‧‧‧Second inner layer film

221‧‧‧The first outer layer film

222‧‧‧The second outer film

223‧‧‧Functional layer for outer film

311‧‧‧ tube

312‧‧‧ flange

321‧‧‧Mounting post

322‧‧‧ plate rib

323‧‧‧Slot

351‧‧‧tube

352‧‧‧ flange

FIG. 1 is a schematic view showing an example of a packaging bag for storing a medicinal solution according to the present invention.

Fig. 2 is a sectional view taken along the line A-A in Fig. 1.

FIG. 3 is an explanatory diagram for explaining the inside of the packaging bag for storing a medicinal solution according to the present invention.

Fig. 4 is a schematic cross-sectional view showing another example of a packaging bag for storing a medicinal solution according to the present invention.

FIG. 5 is an explanatory diagram illustrating the inside of the packaging bag for storing a medicinal solution according to the present invention.

Fig. 6 is a schematic cross-sectional view showing another example of a packaging bag for storing a medicinal solution according to the present invention.

Fig. 7 is a schematic cross-sectional view showing another example of a packaging bag for storing a medicinal solution according to the present invention.

Fig. 8 is a schematic view showing another example of a packaging bag for storing a medicinal solution according to the present invention.

Fig. 9 is a schematic diagram showing another example of a packaging bag for storing a medicinal solution according to the present invention.

10 (a) to (c) are explanatory diagrams illustrating an example of the injection member in the present invention.

11 (a) to (c) are explanatory diagrams illustrating another example of the injection member in the present invention.

Fig. 12 is a schematic view showing another example of a packaging bag for storing a medicinal solution according to the present invention.

Fig. 13 is a schematic view showing another example of a packaging bag for storing a medicinal solution according to the present invention.

Fig. 14 is a sectional view taken along the line A-A in Fig. 13.

FIG. 15 is an explanatory diagram illustrating the inside of the packaging bag for storing a medicinal solution according to the present invention.

Fig. 16 is a schematic sectional view showing an example of a container for storing a medicinal solution according to the present invention.

Fig. 17 is a schematic cross-sectional view showing another example of a container for storing a medicinal solution according to the present invention.

FIG. 18 is an explanatory diagram illustrating a method for dispensing a medicinal solution in a medicinal solution storage container according to the present invention.

FIG. 19 shows the results of gas chromatography mass spectrometry in the case where dimethyl carbonate (DMC) is used in Reference Example 3. FIG.

FIG. 20 shows the results of gas chromatography mass spectrometry in the case where propylene glycol-1-monomethyl ether acetate (PGMEA) was used in Reference Example 3. FIG.

Hereinafter, the packaging bag for medicinal solution storage and the container for medicinal solution storage of the present invention will be described.

The medicinal solution storage packaging bag of the present invention (hereinafter, sometimes referred to simply as a packaging bag for explanation) has an inner bag including an inner layer film and containing the medicinal solution, and an outer layer film and is disposed outside the inner bag The bag body of the outer bag and the injection member joined to the bag body are characterized in that the inner bag and the outer bag have a multilayer structure in which the inner layer film and the outer layer film are stacked on the inner layer. The inner layer film has a film containing a fluorine-containing resin having a melting point of 230 ° C or less on the outermost surface of the chemical liquid side, and the outer layer film is disposed on the heat-sealed portion where the films are facing each other. The laminated film of the first outer layer film on the inner bag side and the second outer layer film arranged on the outer side of the bag body, the first outer layer film is a film for heat welding that can be heat-sealed with the inner layer film, and the above The second outer layer film is a film including a resin having a melting point equal to or higher than the melting point of the fluorine-containing resin of the inner layer film.

In the present invention, "welding" generally refers to heat-welding a plurality of opposing resin films. In addition, in the present invention, the "heat-welding" refers to several pieces facing each other. A state where the resin film surface is melted and bonded by heating. The so-called "thermal fusion bonding" means that a plurality of thermoplastic resin members are heated above a melting point and pressure is applied, whereby the resin members are bonded at a molecular level. The "thermal fusion temperature" refers to the heating temperature of the resin during thermal fusion.

The "temperature equivalent to the melting point of the fluororesin" refers to a temperature in the range of 0.9 to 1.1 times the melting point of the fluororesin, and preferably a temperature in the range of 0.93 to 1.07 times. .

According to the present invention, the inner layer film has a film containing a fluorine-containing resin, and the outer layer film has a film for heat fusion, so that a packaging bag having a multiple structure having an inner bag capable of suppressing the elution of impurities into the drug solution can be produced. Specifically, the inner layer film has a film containing the above-mentioned fluorine-containing resin on the outermost surface of the medicinal solution side, and the dissolution of impurities contained in the medicinal solution can be arranged inside the inner bag which is in direct contact with the medicinal solution. Film of fluororesin. In addition, since the first outer layer film is the above-mentioned heat-welding film, the inner layer film and the first outer layer film can be welded at the heat-welded portion, so that the inner bag and the outer bag can be integrated in the heat-welded portion. Constructed packaging bag. Furthermore, since the second outer layer film is a film containing a resin having a melting point equal to or higher than the melting point of the above-mentioned fluororesin, even when the packaging bag of the present invention is manufactured, the second outer layer film has a multilayer structure. In the case where the inner layer films are heated and the inner layer film and the first outer layer film are thermally welded, the films may be made at a temperature below the melting point of the resin included in the second outer layer film. Since heat welding is performed, deterioration of the second outer layer film can be suppressed.

The packaging bag for storing a medicinal solution according to the present invention has three embodiments according to the structure of the inner layer film and the outer layer film. Hereinafter, embodiments will be described.

The film for thermal fusion in the present invention includes a film containing a fluorine-containing resin having a melting point of 230 ° C or lower, and a film having a melting point equal to or lower than the melting point of the fluorine-containing resin. The concept of a film that is thermally welded at a temperature.

I. First implementation aspect

The packaging bag for medicinal solution storage according to the first embodiment is characterized in that the inner layer film only includes a film containing the above-mentioned fluororesin, and the first heat-sealing film in the first outer layer film contains a melting point of 230 ° C or lower. Film of fluororesin.

That is, the packaging bag for medicinal solution storage according to the first embodiment includes a bag body including an inner bag composed of an inner layer film and containing the medicinal solution, and a bag body composed of an outer layer film and disposed outside the inner bag on the outer side of the inner bag, And an injection member connected to the bag body, wherein the inner bag and the outer bag have a multilayer structure in which the inner layer film and the outer layer film are superimposed in such a state that the inner layer films face each other and overlap each other. In the heat-sealed portion shown below, the inner layer film only includes a film containing a fluorine-containing resin having a melting point of 230 ° C or lower, and the outer layer film is a layer having a fluorine-containing resin disposed on the inner bag side and containing a melting point of 230 ° C or lower A first outer film and a laminated film of a second outer film disposed on the outer side of the bag body and containing a resin having a melting point equal to or higher than the melting point of the fluorine-containing resin of the inner film.

The packaging bag of the first embodiment will be described using drawings. FIG. 1 is a schematic diagram showing an example of a packaging bag according to the first embodiment, FIG. 2 is a cross-sectional view taken along line A-A of FIG. 1, and FIG. 3 is an explanatory diagram illustrating the inside of the packaging bag illustrated in FIG. 1. As shown in FIGS. 1 to 3, the packaging bag 1 includes a bag body 2 including an inner bag 21 composed of an inner layer film 21 a and containing a medicinal solution, and an outer bag composed of an outer layer film 22 a and covering the inner bag. 22; and the injection member 3, which is engaged with the bag body. In addition, the inner bag 21 and the outer bag 22 have a heat-sealed portion 23 in which a multilayer structure formed by overlapping the inner layer film 21a and the outer layer film 22a is welded in a state where the inner layer films 21a overlap each other. First implementation In this case, the inner layer film 21a is a film containing only a fluorine-containing resin having a melting point of 230 ° C or lower. The outer film 22a is a laminated film having a first outer film 221 and a second outer film 222. The first outer film 221 is a fluorine-containing resin disposed on the inner bag side and having a melting point of 230 ° C or lower. The second outer layer The film 222 is a resin which is disposed on the outer side of the bag body 2 and has a melting point equal to or higher than the melting point of the fluororesin of the inner layer film 21a. The packaging bag 1 has a structure in which the heat-sealed portion 23 has a heat-sealed surface 23X for heat-sealing the inner layer films 21a in the multilayer structure, the inner layer film 21a, and the first outer layer film 221, and the inner bag 21 and the outer layer The bag 22 is integrated. In addition, the packaging bag 1 has a structure in which the inner layer film 21 a and the outer layer film 22 a are arranged at intervals in portions other than the heat-welded portion 23. In the packaging bag illustrated in FIGS. 1 to 3, an example in which a part of the ejection member 3 is joined between the inner layer films 21 a in the heat-welded portion 23 is shown. Moreover, the part shown by B in FIG. 1 shows the dual structure of the packaging bag.

According to the first embodiment, the first embodiment can be constituted only by the film containing the fluorine-containing resin containing the above-mentioned inner layer film, and only the film containing the fluorine-containing resin having low dissolution of impurities into the chemical solution. In the packaging bag, the inner bag is in direct contact with the liquid medicine. In addition, since the first outer layer film in the outer layer film is a film containing the fluorine-containing resin, the inner layer film and the first outer layer film can be heat-sealed at the heat-sealed portion, so it can be made into an inner bag of the heat-sealed portion Multi-structured packaging bag with integrated outer bag.

Regarding the first embodiment, since the inner layer film has only a film containing a fluorine-containing resin, the elution of impurities into the drug solution can be more effectively suppressed than the packaging bag of the second embodiment described below.

Furthermore, polytetrafluoroethylene (PTFE), perfluoroalkoxyfluoro resin (PFA), ethylene-tetrafluoroethylene copolymer (ETFE), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), etc. are known in the art. Fluorinated resins are resins with low dissolution of impurities into the chemical solution. However, the thermal welding temperature of these fluororesins is high. Therefore, if a multi-structured packaging bag is used in which a film containing these fluorine-containing resins is applied to an inner layer film and disposed on the medicinal solution side of the inner bag, as the outer layer film, a film containing For resins with a melting point at the thermal fusion temperature, there is a problem that the type of materials that can be used for the outer film is greatly limited. In addition, there is a concern that a fluorine-containing resin generates a thermally decomposed gas due to heating, and in particular, there is a tendency that toxic gases such as hydrogen fluoride are more likely to be generated at higher temperatures. Therefore, when a film containing a fluorine-containing resin such as PTFE is used in an inner bag, heat welding must be performed at a high temperature, so there is a concern that toxic gases such as hydrogen fluoride are generated. In addition, there is a problem that the higher the heating temperature is, the larger the load on a heat-seal device such as a heat sealer when the packaging bag is formed, or the more energy is consumed.

The melting points of the above fluororesins are PTFE 317 ° C to 337 ° C, PFA 302 ° C to 310 ° C, ETFE 254 ° C to 279 ° C, and FEP 260 ° C to 282 ° C, all exceeding 250 (Non-Patent Document 1). Therefore, in the heat welding which must be heated to exceed the melting point of the resin, the heat welding temperature becomes high because it must be heated to the above melting point or higher.

In contrast, in the first embodiment, the above-mentioned inner layer film is only a film containing a fluorine-containing resin having a melting point of 230 ° C. or lower, and the toxicity can be suppressed when the packaging bag of the first embodiment is manufactured. The generation of high thermal decomposition gas can reduce the load on the device for thermal fusion and reduce the energy consumption. Hereinafter, details of the packaging bag according to the first embodiment will be described.

1.Bag body

The bag body in the first embodiment has an inner bag and an outer bag. In the bag body in the first embodiment, the inner bag and the outer bag have a heat-welded portion. Hereinafter, the details of the inner bag, the outer bag, and the heat-welded portion will be described.

(1) Inner bag

The inner bag in the first embodiment is constituted by an inner layer film. In addition, the inner bag contains a medicinal solution. The shape of the inner bag is appropriately determined depending on the shape of the packaging bag of the first embodiment.

(a) Inner film

The inner layer film used in the inner bag will be described below. The inner layer film in the first embodiment includes only a film containing a fluorine-containing resin having a melting point of 230 ° C or lower. The inner layer film in the first embodiment has a function of inhibiting the elution of impurities from the medicinal solution in the inner bag.

A film containing a fluorine-containing resin (hereinafter, sometimes referred to as a fluorine-containing resin film) used in the inner layer film will be described. Here, the "fluorine-containing resin" refers to a synthetic resin obtained by polymerizing an olefin (ethylene-based hydrocarbon or unsaturated hydrocarbon) containing fluorine. In the fluorine-containing resin, a part of the resin may be graft-modified by a compound different from the fluorine-containing olefin described above. The quality of the modification is preferably about 0.01% by mass to 1% by mass. The so-called "film contains fluororesin" is not particularly limited as long as the melting point of the inner film is the same as the melting point of the fluororesin, and it can suppress the dissolution of impurities into the drug solution. The content of the fluororesin is a drug. The use of the liquid storage packaging bag is appropriately selected. The content of the fluorine-containing resin in the film is, for example, 70% by mass or more, preferably 80% by mass or more, and particularly preferably 90% by mass or more. The higher the effect of suppressing the dissolution of impurities into the medicinal solution, the higher the content of the fluororesin is. The melting point of the inner layer film can be measured by the same method as the method for measuring the melting point of a fluorine-containing resin described below.

The fluorine-containing resin film may contain only a fluorine-containing resin, or may further contain Resin for fluororesin. From the viewpoint of suppressing the elution of impurities into the chemical solution, it is more preferable that the fluororesin is contained only.

The inner layer film is only required to include a fluorine-containing resin film, and a single-layer fluorine-containing resin film is usually used. The inner layer film may be, for example, a laminated film obtained by laminating a plurality of fluorine-containing resin films. In this case, the laminated film does not include a resin film other than the fluororesin film.

(i) Fluorinated resin

The fluorine-containing resin in the first embodiment is not particularly limited as long as the melting point is 230 ° C or lower. That is, the melting point of the fluorine-containing resin in the first embodiment is not particularly limited as long as it is 230 ° C or lower. Among them, the range of 150 ° C to 230 ° C is preferred, and the range of 150 ° C to 220 ° C is particularly preferred. Inside. The reason is that when the melting point of the fluororesin exceeds the above-mentioned value, since the load on the outer film heating becomes large, it may become difficult to manufacture the packaging bag itself, or the type of resin that may be used for the outer film is affected. Big restrictions. In addition, there is a concern that the load on the relevant manufacturing equipment when manufacturing the packaging bag of the first embodiment is increased, or that the thermal decomposition gas of the fluororesin is likely to be generated. The melting point of the fluorine-containing resin is an endothermic peak of differential scanning calorimetry (DSC), and is measured by a method in accordance with JIS K6935.

Specific examples of the fluorine-containing resin contained in the inner film include polyvinyl fluoride (PVF), polyvinylidene fluoride (PVDF), polychlorotrifluoroethylene (PCTFE), and ethylene-tetrafluoroethylene- Hexafluoropropylene copolymer (EFEP), low melting point ETFE (LM-ETFE), etc. Examples of commercially available products include Fluon (registered trademark) LM-ETFE manufactured by Asahi Glass Co., Ltd., and Neoflon (registered trademark) EFEP manufactured by Daikin Industry Co., Ltd. Among them, in the first embodiment, It is better to use LM-ETFE and EFEP. The melting point of LM-ETFE is, for example, 225 ° C, and the melting point of EFEP is, for example, 195 ° C. Therefore, it is LM-ETFE and EFEP because it has a low melting point and is easy to perform heat fusion. The fluororesin may be used singly or in combination of two or more kinds.

(ii) resins other than fluororesin

In the first embodiment, the fluorine-containing resin film may optionally include a resin (other resin) other than the fluorine-containing resin.

Examples of other resins include polyamide, polyester, ethylene-vinyl alcohol copolymer resin (EVOH), ethylene-methacrylic acid copolymer resin (EMAA), modified polyolefin, and low-density polyethylene (LDPE). Wait. Among the specific examples of these resins that are not fluorinated resins, in terms of high adhesion to the fluorinated resins, preferred examples include polyamines, EVOH, and modified polyolefins.

Examples of polyamidamine include nylon 6 (PA6) as a polymer of ε-caprolactam, nylon 66 (PA66) as a polymer of hexamethylenediamine and adipic acid, and polymerization of lauryllactam. Nylon 12 (PA12), nylon 11 (PA11) as a polymer of undecyllactam, nylon 6/66 (PA6 / 66) as a copolymer of PA6 and PA66, and the like. Among the specific examples of these polyamides, PA6 is preferably mentioned in terms of a melting point close to that of the fluororesin. The melting point of PA6 is, for example, 225 ° C.

Examples of the polyester include polyethylene terephthalate (PET), polytrimethylene terephthalate (PPT), polybutylene terephthalate (PBT), and polyethylene naphthalate (PEN), polybutylene naphthalate (PBN), and the like. Among the specific examples of these polyesters, in terms of the melting point being close to that of the fluororesin, PBT is preferred. The melting point of PBT is, for example, in a range of 232 ° C to 267 ° C.

As commercially available products, for example, nylon manufactured by DuPont as a polyamide, Eval (registered trademark) manufactured by Kuraray as EVOH, and Admer (registered trademark) manufactured by Mitsui Chemicals Co., Ltd. as a modified polyolefin. Trademarks), Modic (registered trademark) manufactured by Mitsubishi Chemical Corporation, Mersen G (registered trademark) manufactured by Tosoh Corporation, Hardlen (registered trademark) manufactured by Toyo Textile Co., Ltd., etc.

The content of other resins in the fluororesin film is not particularly limited as long as the melting point of the inner layer film is the same as the melting point of the fluororesin, and the elution of impurities into the medicinal solution is suppressed. The content of other resins in the fluororesin film is appropriately adjusted depending on the content of the above-mentioned fluororesin.

(b) Other

The thickness of the inner layer film is not particularly limited as long as it can suppress the dissolution of impurities from the inner bag into the medicinal solution, and can be appropriately selected according to the use of the packaging bag of the first embodiment. The thickness of the inner layer film is, for example, in a range of 5 μm to 120 μm, and preferably in a range of 5 μm to 110 μm, and particularly preferably in a range of 5 μm to 100 μm. The reason is that if the thickness of the inner layer film is too thin, the inner bag may easily break. The reason is that it may become difficult to sufficiently thermally weld the inner layer films to each other in the heat-sealed portion. The reason is that it may become difficult to form the inner layer film well. The reason is that if the thickness of the inner layer film is too thick, it becomes difficult to transfer heat to the thickness direction of the multilayer structure during the production of the packaging bag of the first embodiment, and therefore it may become difficult to make the inner layer films to each other. Fully heat-sealed, or it may take a long time. The reason is that if the thickness of the inner layer film is too thick, the flexibility of the packaging bag may be reduced, or it may be difficult to use it in a case for storing a liquid medicine. Follow the outer container.

The method for forming the inner layer film can be the same as the method for forming a normal resin film, and examples thereof include a melt extrusion method. As a method for forming an inner layer film using a plurality of resins, a melt-kneading extrusion method is exemplified: after several resins are melt-kneaded and homogenized, the molten resin is extruded from a die of an extruder to form a film . Specific examples of the melt extrusion method and the melt-kneading extrusion method include a T-shaped die method using a T-shaped die as a die head or a circular die nozzle as a die and feeding air into the inside. Inflation method.

(2) Outer bag

In the first embodiment, the outer bag is composed of an outer film. The outer bag is arranged outside the inner bag. Here, the so-called "arrangement of the outer bag on the outer side of the inner bag" refers to the concept of not only the case where the outer bag is arranged to cover the inner bag, but also the case where the inner bag is partially exposed from the outer bag. The shape of the outer bag is appropriately determined depending on the shape of the packaging bag of the first embodiment. The outer layer film used in the outer bag will be described below.

(a) Outer film

The outer layer film in the first embodiment has a laminated film of a first outer layer film and a second outer layer film. More specifically, in the outer layer film in the first embodiment, one surface of the first outer layer film is laminated and formed into a second outer layer film to form a single film. Furthermore, in the outer layer film, a second outer layer film may be directly laminated and formed on one surface of the first outer layer film, or a second outer layer may be formed in layers on one surface of the first outer layer film with other layers interposed therebetween. membrane.

(i) First outer film

The first outer layer film in the first embodiment is a film containing a fluorine-containing resin having a melting point of 230 ° C or lower. The first outer layer film is arranged on the inner bag side. The first outer layer film in the first embodiment has a function of heat-sealing the inner layer film in the outer bag and the inner layer film in the inner bag to make the bag body a multiple structure.

The fluorine-containing resin contained in the first outer layer film is not particularly limited as long as the melting point is 230 ° C or lower, and may be the same as the fluorine-containing resin contained in the inner layer film, or may be different from the fluorine-containing resin contained in the inner layer film. . In the first embodiment, it is preferable that the fluorine-containing resin contained in the first outer film is the same as the fluorine-containing resin contained in the inner film. The reason is that the inner layer film and the first outer layer film can be thermally welded well. The fluorine-containing resin film used as the first outer layer film may be the same as the fluorine-containing resin film used in the first inner layer film, or may be different from the fluorine-containing resin film used in the first inner layer film. The details of the fluorine-containing resin and the fluorine-containing resin film included in the first outer layer film are the same as those described in the item "(1) Inner bag", and therefore the description here is omitted.

The thickness of the first outer layer film is not particularly limited as long as it can be thermally welded to the inner layer film, and can be appropriately selected according to the use of the packaging bag of the first embodiment. The thickness of the first outer layer film is, for example, in a range of 5 μm to 100 μm, in which a range of 5 μm to 80 μm is preferred, and a range of 5 μm to 60 μm is particularly preferred. The reason is that if the thickness of the first outer layer film is too thin, it may become difficult to sufficiently thermally weld the inner layer film. The reason is that it may be difficult to form a good film shape by laminating it with the second outer layer film described below. The reason is that if the thickness of the first outer layer film is too thick, it becomes difficult to transfer heat to the thickness direction of the multilayer structure during the production of the packaging bag of the first embodiment, so that it may become difficult to make the inner layer film. And the first outer layer film may be thermally welded, or it may become difficult to thermally weld the inner layer films to each other. Again, the reason is: It may take more time for thermal welding.

(ii) The second outer layer film

The second outer layer film in the first embodiment is a film disposed on the outer side of the bag body and containing a resin having a melting point equal to or higher than the melting point of the fluorine-containing resin of the inner layer film. The second outer layer film is disposed on the outer side of the bag body. The second outer film in the first embodiment has a function of imparting a predetermined strength to the outer bag.

The resin contained in the second outer layer film is not particularly limited as long as it has a melting point equal to or higher than the melting point of the fluororesin of the inner layer film. The so-called "temperature equal to or higher than the melting point of the fluorine-containing resin of the inner layer film" means the above-mentioned "temperature equal to or higher than the melting point of the fluorine-containing resin". As the melting point of the resin contained in the second outer layer film, specifically, it is 230 ° C or higher, preferably 230 ° C to 500 ° C, particularly preferably 230 ° C to 400 ° C, and more preferably In the range of 230 ℃ ~ 300 ℃. The reason is that when the melting point of the resin contained in the second outer film is less than the above value, the heat load on the second outer film is caused when the inner films are thermally welded to each other, and the inner film and the first outer film are thermally welded. It becomes large, so that it may become difficult to manufacture the packaging bag itself of the first embodiment. In addition, the reason is that there is a concern that the load on the manufacturing apparatus becomes large when the packaging bag of the first embodiment is manufactured, or that the thermal decomposition gas of the fluororesin is likely to be generated. The melting point of the resin contained in the second outer film is a value measured by a differential scanning calorimetry (DSC) as an endothermic peak and measured by a method according to JIS K6935.

Specific examples of the resin included in the second outer film include nylon (Ny), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), and polynaphthalene. Ethylene formate (PEN), polycarbonate (PC), polyimide, etc. to When nylon or polybutylene terephthalate is included as the second outer film, the impact resistance can be improved. When nylon or polyethylene terephthalate is included, the gas can be blocked. Sex becomes better. As described above, depending on the resin selection of the second outer layer film, desired characteristics can be imparted to the outer bag. When the packaging bag of the first embodiment is used to store, for example, the electrolyte solution of a lithium ion battery, the second outer layer film is preferably PET or PBT. The reason is that the second outer layer film can be made to have a lower water content, and the deterioration of the above-mentioned electrolytic solution and the like can be more effectively suppressed.

The thickness of the second outer layer film is not particularly limited as long as it can be laminated with the first outer layer and formed into a film shape, and can give a predetermined strength to the outer bag. select. The thickness of the second outer layer film is, for example, within a range of 10 μm to 100 μm, and among them, preferably within a range of 10 μm to 90 μm, and particularly preferably within a range of 15 μm to 80 μm. The reason is that if the thickness of the second outer layer film is reduced, it may become difficult to provide sufficient strength to the outer bag. The reason is that if the thickness of the second outer layer film is too thick, it becomes difficult for heat to be transmitted to the thickness direction of the multilayer structure in the heat-sealed portion during the production of the packaging bag of the first embodiment, so that it may become It is difficult to sufficiently thermally weld the inner layer films, the inner layer film, and the first outer layer film.

(iii) Functional layer for outer film

The outer layer film in the first embodiment is not particularly limited as long as it has the first outer layer film and the second outer layer film described above. For example, as shown in FIG. There is a functional layer 223 for an outer layer film therebetween. Since the outer film 22a is a laminated film having the outer film functional layer 223, a predetermined function can be imparted to the outer bag.

Examples of the function of the functional layer for the outer film include ultraviolet absorption. Light absorption function at specific wavelengths such as light, barrier function to gas, moisture, etc., impact resistance function, antistatic function, etc.

The material used as the functional layer for the outer film may be a resin material or an inorganic material. Examples of the resin material include PET, PBT, Ny, polyethylene (PE), polyvinyl alcohol (PVA), ethylene-vinyl acetate copolymer (EVA), and ethylene-vinyl alcohol copolymer (EVOH). Examples of the inorganic material include aluminum, aluminum oxide, and silicon oxide (transparent vapor deposition).

The thickness of the functional layer for the outer layer film is not particularly limited as long as it can provide a predetermined function to the outer layer film and can be laminated and formed between the first outer layer film and the second outer layer film, and is within the range of 10 μm to 100 μm. Among them, it is preferably within a range of 10 μm to 80 μm, and particularly preferably within a range of 10 μm to 60 μm. The reason is that when the thickness of the functional layer for the outer film is too thick, the moldability of the outer bag may be reduced, or the flexibility of the outer bag may be reduced. The reason is that when the thickness of the functional layer for the outer layer film is too thin, it may become difficult to form the functional layer for the outer layer film and impart a desired function to the outer layer film.

The method for forming the functional layer for the outer layer film is not particularly limited as long as it can form a functional layer for the outer layer film having a predetermined function between the first outer layer film and the second outer layer film. For example, when the functional layer for an outer layer film contains a resin, it can be used for the method demonstrated in the formation method of an outer layer film mentioned below. In addition, for example, when the functional layer for an outer film is composed of an inorganic material, for example, a vapor deposition method such as a vacuum deposition method or a sputtering method can be used.

(iv) Outer film

In the first embodiment, the outer layer film includes the first outer layer film and the second outer layer film. Of laminated film. The thickness of the outer layer film is not particularly limited as long as it can impart a predetermined strength to the outer bag, and can be appropriately selected according to the use of the packaging bag of the first embodiment and the like. The thickness of the outer layer film is, for example, in a range of 15 μm to 150 μm, and preferably in a range of 20 μm to 130 μm, and particularly preferably in a range of 20 μm to 100 μm. The reason is that when the thickness of the outer film is too thin, when the outer bag of the first embodiment is filled with a medicinal solution, the outer bag may be broken due to the weight of the medicinal solution. The reason is that when the thickness of the outer layer film is too thick, it may become difficult to manufacture the packaging bag of the first embodiment. The reason is that there is a possibility that the flexibility of the packaging bag is reduced, and it becomes difficult to follow the container for storing the medicinal solution.

The method for forming the outer layer film is not particularly limited as long as it is a method of laminating and forming the first outer layer film and the second outer layer film, and it can be the same as the method for forming a normal laminated film. Examples of the method for forming the outer layer film include a co-extrusion method using an inflation method, a co-extrusion method using a T-die method, and other co-extrusion methods. A co-extrusion lamination method for simultaneous supply of resin, an extrusion coating lamination method in which a resin is melted and extruded in a film form from a T-die onto a film substrate containing different resins, and an adhesive is used. Laminated dry lamination. In addition, for example, the first outer layer film and the second outer layer film are formed separately, and the two are opposed to each other, and thermal compression bonding is performed by a hot press, thereby forming the outer layer film. Among the first embodiment, a coextrusion method using an inflation method is preferred. In order to form the outer film into a tubular shape, the first outer film and the second outer film are formed into a tubular shape, and heat-sealed portions are formed at both ends of the tube, thereby reducing the heat-sealed portion and forming a packaging bag.

The combination of the resins included in the first outer film and the second outer film (resin of the first outer film / resin of the second outer film) is not particularly limited. For example, EFEP / PBT, EFEP / PA66, and LM are preferred. -ETFE / PBT, LM-ETFE / PA66. Such The laminated film can be formed using, for example, a coextrusion laminated molding method.

(b) Other

In the first embodiment, the outer bag covers the inner bag, and protects the inner bag from the impact and friction from the outside of the packaging bag of the first embodiment. In the outer bag, a first outer film is disposed on the inner bag side, and a second outer film is disposed on the outer side of the bag body.

(3) Intermediate bag

As for the packaging bag of the first embodiment, as shown in FIG. 5 to FIG. 7, the bag body 2 further preferably has an intermediate bag 24 which is disposed between the inner bag 21 and the outer bag 22 and is composed of an intermediate film 24 a. In this case, the multilayer structure in the heat-welded portion 23 described below has a structure in which the inner layer film 21a, the intermediate film 24a, and the outer layer film 22a are stacked. In addition, the intermediate film 24a is characterized by having a film containing a fluorine-containing resin that can be thermally welded at a temperature of 230 ° C or lower. The intermediate bag 24 is usually arranged so as to cover the inner bag 21 and be covered with the outer bag 22. In addition, FIG. 5 is an explanatory diagram for explaining the inside of the medicinal solution storage packaging bag according to the first embodiment. 6 and 7 are schematic cross-sectional views showing another example of a packaging bag for storing a medicinal solution according to the first embodiment.

In the first embodiment, the strength of the packaging bag can be made higher by having an intermediate bag.

The intermediate film is a film containing a fluorine-containing resin having a melting point of 230 ° C. or lower, and more specifically, a film containing the above-mentioned fluorine-containing resin is provided on the surface of the inner bag side and the outer bag side. Such an intermediate film 24a may be, for example, a film containing only the above-mentioned fluorine-containing resin, as shown in FIG. 6, or, for example, as shown in FIG. 7, a first intermediate containing fluorine-containing resin may be used. Film 241, functional layer 242 for intermediate film, and A laminated film formed by stacking 3 layers of 2 intermediate films 243.

When the interlayer film includes only a film containing a fluorine-containing resin, the type of the fluorine-containing resin and the thickness of the intermediate film can be set to be the same as those described in the item of the above-mentioned inner layer film, so the description here is omitted. Instructions. When the interlayer film is a laminated film of the above three layers, the functional layer for the interlayer film may be the same as that described in the item of the functional layer for the outer layer film. The first interlayer film and the second interlayer film may be the same as those described in the item of the first outer layer film, and therefore description thereof will be omitted.

In addition, in the first embodiment, one intermediate bag may be arranged between the inner bag and the outer bag, or two or more bags may be arranged. That is, the packaging bag of the first embodiment may have a three-layer structure, or may have a multiple structure thereon.

(4) Thermal welding

The inner bag and the outer bag in the first embodiment have a heat-sealed portion. In the first embodiment, the heat-welded portion has a multilayer structure formed by overlapping the above-mentioned inner layer film and the above-mentioned outer layer film in a state where the above-mentioned inner layer films face each other and overlap each other. Usually, the multiple-layer structure The layers are thermally welded in a state where the layers overlap each other. In the packaging bag according to the first embodiment, the heat-sealed portion is a portion where the inner bag and the outer bag are integrated.

In the heat-sealed portion in the first embodiment, two multilayer structures are usually arranged so that the inner layer films face each other. In addition, as shown in FIG. 2, the heat-sealed portion usually heat-welds the inner layer films 21 a, the inner layer film 21 a, and the first outer layer film 221 to have a heat-welded surface 23X.

The formation position of the heat-welded portion can be appropriately selected according to the form of the inner layer film and the outer layer film. For example, when the inner film and outer film are sheet-like, prepare a sheet When the inner layer film and the outer layer film each have two pieces, and the four layers are overlapped such that the inner layer films face each other so that the multilayer structure overlaps each other, as shown in FIG. In one embodiment, the heat-welded portions 23 are formed on the four sides. When a sheet-shaped inner layer film and an outer layer film are prepared, and when the inner layer film and the outer layer film are overlapped, the multilayer structure is overlapped with each other, as shown in FIG. 9, Three sides are formed with heat-welded portions 23. When the inner layer film and the outer layer film are tubular, the inner layer film 21a and the outer layer film 22a can be arranged concentrically as shown in Figs. The two sides are formed with the heat-welded portion 23. In addition, FIG. 8 and FIG. 9 are schematic diagrams showing another example of the packaging bag according to the first embodiment. Regarding the unexplained symbols, the same symbols as those described in FIG. 1 and the like may be used, and thus omitted here. Description. In addition, in FIGS. 8 and 9, for convenience of explanation, the inner bag is omitted.

The heat-welded portion may be formed in an arc shape as shown in FIG. 1 or the like, or may be formed in a linear shape with respect to a portion provided at an inner edge corner portion of the bag body, but it is not shown. In the case where the above-mentioned inner edge corner portion of the heat-sealed portion is formed into an arc shape, it is possible to make a solution in which the medicinal solution is difficult to remain in the above-mentioned inner edge corner portion.

In addition, in the case where the injection member and a part of the heat-sealed portion are joined as described below, as shown in FIG. 1, the heat fusion portion 23 may be formed so as to be wider than the width of the joint portion with the injection member 3. x1, and the width x2 at both ends is formed to be tapered.

The width of the heat-sealed portion is not particularly limited as long as the inner-layer films, the inner-layer film, and the first outer-layer film can be heat-fused, and can be appropriately selected according to the use of the packaging bag and the like. The width of the heat-welded portion is specifically within a range of 5 mm to 40 mm, preferably within a range of 5 mm to 35 mm, and particularly preferably within a range of 5 mm to 30 mm. The reason is that when the width of the heat-sealed portion is too small, It may become difficult to obtain sufficient sealing strength. In the case where the width of the heat-sealed portion is too large, the entire bag size must be enlarged in order to secure the volume inside the bag, and thus the handleability may be reduced. The width of the heat-sealed portion refers to the minimum width of the heat-sealed portion.

As the bonding strength between the inner layers of each of the heat-sealed portions, and the heat-sealed surfaces of the inner layer and the first outer layer, as long as the medicinal solution can be stored and held inside the packaging bag of the first embodiment. , It is not particularly limited, and may be appropriately selected according to the use of the packaging bag of the first embodiment. The bonding strength of the heat-welded surfaces of the inner layer films in the heat-welded portion is, for example, 15N / 15mm or more, and preferably 20N / 15mm or more, and more preferably 30N / 15mm or more. The reason is that when the strength is too low, the bag may be broken due to the weight of the medicinal solution stored in the packaging bag of the first embodiment. Moreover, as said adhesive strength, it is preferable that it is 80 N / 15 mm or less, for example. The reason is that it is easy to adjust the heat welding time and heating temperature when manufacturing the packaging bag of the first embodiment. The above-mentioned adhesion strength can be measured by setting the moving speed to 300 mm / min, the width of the measurement sample to 15 mm, and performing a T-peel adhesion strength test under other conditions in accordance with JISZ0238.

The method for forming the heat-sealed portion is not particularly limited as long as the inner-layer films, the inner-layer film, and the first outer-layer film can be welded in a multilayer structure, and it can be set to a heat used for processing of a normal heat-sealed film. The welding method is the same. As a specific method of thermal welding, for example, an ultrasonic welding method is used, in which ultrasonic vibration of about 15 kHz to 50 kHz is applied to a film (member) together with pressure, thereby heating the film with frictional heat generated from the film. A method of bonding; a vibration welding method, which uses a lower frequency of about 100 Hz to 300 Hz to transmit a lateral vibration with a large amplitude to the film, thereby heating the film by frictional heat generated from the film to perform bonding; induction Welding Method, which uses electromagnetic induction that uses an electromagnetic induction coil to flow electric current to the object being physically separated, and heats the film by induction heating generated from the film to join them; high-frequency welding, which uses high-frequency energy The method of applying electric field to heat the film itself from the inside, thereby heating and bonding the films; the semiconductor laser welding method, superimposes and irradiates the light-transmitting transparent resin with the light-absorbing resin with appropriate pressure Laser, a method in which the absorptive resin heats up to generate light heating, and the films are heated and bonded by the light heating; the hot plate welding method, a hot plate overheated by a heater is directly pressed against the film, A method for heating and bonding the films by utilizing the effect of heat conduction; a pulse welding method in which a heating wire is pressurized to the film, and a large current flows instantaneously to heat the heating wire, thereby heating the film and bonding; A soldering-iron welding method in which a heating plate called a soldering iron is inserted between opposing films, thereby heating the films and bonding them by applying pressure from a roller; Welding method, a film was fixed, so that rotation of the other film sheet and pressurized, whereby the friction heat generated in the use of the contact surface of the film joining method of heating and the like. Among the above-mentioned methods of thermal fusion, in terms of a large amount of fusion of the film to stabilize the fusion state or high productivity, it is preferable to use a hot plate fusion method, a pulse fusion method, or a soldering iron type fusion method. Specific examples of these preferred methods of heat welding are collectively referred to as heat sealing.

The heat-sealing machine used for heat-sealing can be a well-known method.

(5) Bag body

The bag system in the first embodiment has the above-mentioned inner bag and outer bag. The shape of the bag body in the first embodiment can be appropriately selected according to the use of the packaging bag in the first embodiment, and is not particularly limited. The shape can be the same as that used in ordinary packaging bags, and is therefore omitted. Explanation here. The pocketbook system in the first embodiment usually has Double construction of inner bag and outer bag. Moreover, when the said intermediate | middle bag is provided, it can be set as a multiple structure.

2. Inject components

The injecting member in the first embodiment is the one connected to the bag body. In addition, the ejection member in the first embodiment is provided in the packaging bag with an ejector that communicates the inside of the inner bag with the outside of the packaging bag.

As a form of such an ejection member, a known member can be used as an ejection member used in a packaging bag. FIG. 10 (a) is a schematic diagram showing an example of an injection member used in the first embodiment, FIG. 10 (b) is a cross-sectional view taken along the line AA of FIG. 10 (a), and FIG. 10 (c) is a drawing from FIG. 10 (a) A schematic plan view viewed in the B direction. As shown in Figs. 10 (a) to (c), for example, as the ejection member 3, there may be an ejection outlet joint portion 31 disposed outside the packaging bag; and the ejection member 3 is attached to the ejection outlet installation portion of the bag body. 32; and an intermediate pillar portion 33 that combines the injection port joint portion 31 and the injection port mounting portion 32. Further, the ejection member 3 includes an opening portion 34 that penetrates the ejection port joint portion 31, the intermediate pillar portion 33, and the ejection port mounting portion 32. In the injection member 3 shown in FIGS. 10 (a) to (c), for example, the injection port joint portion 31 includes a cylindrical portion 311 including a bottom portion having a substantially U-shaped cross-sectional shape, and A flange portion 312 protruding from the periphery of the upper end to the outside. In addition, the intermediate pillar portion 33 is cylindrical, and is formed so that its diameter is smaller than the diameter of the cylindrical portion 311 of the injection port joint portion 31. The injection port mounting portion 32 includes a cylindrical mounting pillar portion 321 formed continuously from the intermediate pillar portion 33 and a plate-shaped rib portion 322 disposed on a side surface of the mounting pillar portion 321. The injection port mounting portion 32 may include a groove portion 323. By having the groove portion, the resin of the inner layer film can enter the groove portion during heat welding, so that the bag body and the columnar member can be well joined. In the case where the injection member is in the above-mentioned form, The ejection member is usually joined to a part of the heat-welded portion 23 of the bag body 2 as shown in FIG. 1. More specifically, an injection port mounting portion is disposed between the opposed inner layer films of the multilayer structure, and a part of the inner layer film and the injection port mounting portion are thermally welded to be joined.

The details of the form of the above-mentioned injection member may be the same as those described in, for example, Japanese Patent No. 5008908, and therefore descriptions thereof are omitted here.

FIG. 11 (a) is a schematic diagram showing another example of the injection member used in the first embodiment, FIG. 11 (b) is a cross-sectional view taken along line AA of FIG. 11 (a), and FIG. 11 (c) is a drawing 11 (a) is a schematic plan view of the B direction. As shown in FIGS. 11 (a) to (c), for example, as the ejection member 3, a nozzle outlet body 35 and a bottom mounting ring 36 are listed. The injection outlet body 35 has a cylindrical portion 351 having a bottom and a protrusion. The edge portion 352 is provided to be connected to the bottom of the cylindrical portion 351. An opening portion 34 is provided on the bottom of the cylindrical portion 351. When the ejection member is the one having the above-mentioned shape, the ejection member is usually joined to a part of the side surface of the bag body 2 as shown in FIG. 12. More specifically, a hole is made in a part of the surface of the inner bag and the outer bag, and the injection port body is inserted into the hole, so that the inner film and the bottom mounting ring are welded and joined. In addition, as the welding method used in this case, in addition to the thermal welding method, an ultrasonic welding method, a solvent welding method, and the like can be cited. In addition, the inner layer film and the bottom mounting ring may be bonded using an adhesive, for example.

Regarding the details of the form of the above-mentioned injection member, for example, it can be set to be the same as that described in Japanese Patent No. 4920678, so the description here is omitted.

As a material of the injection member, a resin is usually used. In addition, it is preferable that the injection member is thermally welded to the inner film to be joined. Therefore, as a material of the injection member, it is preferable to include a fluorine-containing resin that can be thermally welded at 230 ° C or lower. As the material of the injection member, it is more preferable to include a fluorine-containing resin similar to the fluorine-containing resin contained in the inner layer film. The reason is that the two can be thermally welded well, and the packaging bag and the injection member can be good. To ground.

In addition, in the first embodiment, when the above-mentioned fluororesin is used as the material of the injection member, as long as at least the surface of the injection member contains a fluororesin, the entire injection member may be composed of the above-mentioned fluororesin. It is also possible that only the surface of the member contains a fluororesin, and the other parts are made of a resin other than the above-mentioned fluororesin. In this case, examples of the resin other than the fluorine-containing resin include PE, PP, Ny, and PET.

The method for forming the injection member may be the same as the method for forming the injection member of a general packaging bag, and specifically, an injection molding method may be used.

3. Other components

The packaging bag according to the first embodiment is not particularly limited as long as it has the bag body and the ejection member, and other components may be appropriately selected and added as necessary. For example, the cover which covers an injection member, etc. are mentioned.

4.packing bag

The packaging bag according to the first embodiment is usually placed in an outer container and used in a container for storing a medicinal solution. The medicinal solution storage container is described in the following item "B. medicinal solution storage container", and therefore description thereof is omitted here.

The manufacturing method of the packaging bag according to the first embodiment is not particularly limited, and it may be the same as the manufacturing method of a general packaging bag. For example, an inner layer film and an outer layer film are prepared separately. Next, the inner layer film and the outer layer film are stacked to form a multilayer structure. Next, the multilayer structure is overlapped such that the inner layer films face each other, and a part of the multilayer structure is heated from the outer side of the outer layer film, thereby causing the inner layer films to each other, the inner layer film, and the first layer. 1 The outer film is thermally welded to form a thermally welded portion. In the manufacturing method described above, it is preferred that the inner surface side of the inner layer film is washed before the formation of the heat-welded portion. The reason is that the particles and the like adhered to the liquid side of the inner bag in the first embodiment can be reduced, and the inner layer film after washing can be easily dried.

Examples of the chemical solution that can be used in the packaging bag of the first embodiment include, for example, photoresist, etching solution, chemical vapor deposition reagents, solvents, cleaning liquids such as wafers, and electrolytes used in lithium ion batteries. Etc., but not limited to them.

II. Second implementation aspect

The packaging bag for storing a medicinal solution according to a second embodiment is characterized in that the inner layer film is a first inner layer film having a fluorine-containing resin disposed on the side of the medicinal solution and containing a melting point of 230 ° C. or lower, and is disposed on the first layer film. Laminated film of the second inner layer film on the outer bag side and containing a resin which can be heat-sealed at a temperature equal to or lower than the melting point of the above-mentioned fluororesin. The heat-sealing film in the outer layer film includes A film of a resin that is thermally fused at a temperature equal to or lower than the melting point of the fluororesin.

That is, the packaging bag for medicinal solution storage according to the second embodiment has a bag body including an inner bag composed of an inner layer film and storing the medicinal solution, and an outer bag composed of an outer layer film and disposed outside the inner bag. And an injection member joined to the bag body, wherein the inner bag and the outer bag have a multilayer structure formed by overlapping the inner layer film and the outer layer film so that the inner layer films overlap each other. In the state of thermal welding, the inner layer film is a laminated film of the first inner layer film and the second inner layer film. The first inner layer film is disposed on the side of the chemical solution and contains a melting point of 230 ° C or lower. A fluorine-containing resin, wherein the second inner layer film is disposed on the outer bag side and contains a resin that can be heat-sealed at a temperature equal to or lower than the melting point of the fluorine-containing resin, and the outer layer film is A laminated film of a first outer layer film and a second outer layer film. The first outer layer film is disposed on the inner bag side and contains a resin that can be heat-sealed at a temperature equal to or lower than the melting point of the fluororesin. The second outer layer film is disposed on the outer side of the bag body and includes a resin having a melting point equal to or higher than the melting point of the fluororesin.

The packaging bag according to the second embodiment will be described with reference to the drawings. FIG. 13 is a schematic view showing an example of a packaging bag according to the second embodiment, FIG. 14 is a cross-sectional view taken along the line A-A in FIG. 13, and FIG. 15 is an explanatory view illustrating the inside of the packaging bag illustrated in FIG. 13. As shown in FIGS. 13 to 15, in the second embodiment, the inner layer film 21 a is a laminated film of the first inner layer film 211 and the second inner layer film 212, and the first inner layer film 211 is disposed on the medicine. The liquid side contains a fluorine-containing resin having a melting point of 230 ° C or lower. The second inner layer film 212 is a resin disposed on the outer bag 22 side and containing a resin that can be heat-sealed at a temperature equal to or lower than the melting point of the fluorine-containing resin. . The outer layer film 22a is a laminated film of the first outer layer film 221 and the second outer layer film 222. The first outer layer film 221 is disposed on the inner bag 21 side and may include a temperature equal to or lower than the melting point of the fluorine-containing resin. The second outer layer film 222 is a resin that is heat-sealed, and is disposed on the outer side of the bag body 2 and includes a resin having a melting point equal to or higher than the melting point of the fluorine-containing resin. The packaging bag 1 has a structure in which the heat-sealed portion 23 includes heat-sealed surfaces 23X, which heat-seal the first inner layer films 211 in the multilayer structure, and the second inner layer film 212 and the first outer layer film 221. The bag 21 and the outer bag 22 are integrated. In addition, the packaging bag 1 has a structure in which the inner layer film 21 a and the outer layer film 22 a are arranged at intervals apart from the heat-sealed portion 23. It should be noted that the symbols not described in FIGS. 13 to 15 may be the same as those described in FIGS. 1 to 3.

According to the second embodiment, the inner layer film is The first inner layer film containing a fluorine-containing resin having a low dissolution rate of impurities into the medicinal solution can be disposed on the medicinal solution side of the inner bag. In addition, since the inner layer film has a second inner layer film and the outer layer film has a first outer layer film, the second inner layer film and the first outer layer film can be thermally welded to the heat welding portion, so that it can be made into a heat welding portion. The inner bag and the outer bag are integrated.

In addition, according to the second embodiment, the inner layer film has a second inner layer film, and the thickness and material of the second inner layer film can be selected to adjust the strength of the inner bag. Therefore, even when the thickness of the first inner layer film is reduced, the strength of the inner bag can be ensured, and the use amount of the relatively expensive fluororesin can be reduced, and a low-cost packaging bag can be made.

As explained in the item of "I. First Embodiment", fluorine-containing resins such as PTFE have a higher melting point, so there are restrictions on the material of the outer film, concerns about the generation of toxic gases during processing, and more energy consumption. And other issues. In contrast, in the second embodiment, since the first inner layer film includes the above-mentioned fluorine-containing resin, a general-purpose resin film can be used for the outer layer film. In the manufacturing of the packaging bag of the second embodiment, the generation of thermally decomposable gas with high toxicity can be suppressed, the load on the apparatus for thermal fusion can be reduced, and the energy consumption can be reduced.

The details of the packaging bag according to the second embodiment will be described below.

1.Bag body

The bag body in the second embodiment has an inner bag and an outer bag. In the bag body in the second embodiment, the inner bag and the outer bag have a heat-sealed portion.

(1) Inner bag

The inner bag in the second embodiment is constituted by an inner layer film.

(a) Inner film

The inner layer film in the second embodiment is a laminated film of the first inner layer film and the second inner layer film. More specifically, in the inner layer film in the second embodiment, one surface of the first inner layer film is laminated and formed into a second inner layer film to form a single film. In addition, in the inner layer film, a first inner layer film may be laminated directly on one surface to form a second inner layer film, or another layer may be layered on one surface of the first inner layer film with another layer interposed therebetween. A second inner layer film is formed.

(i) First inner layer film

The first inner layer film in the second embodiment is a film containing a fluorine-containing resin having a melting point of 230 ° C or lower. The first inner layer film is disposed on the side of the chemical solution. In addition, in the second embodiment, the first inner layer films are usually arranged to face each other and thermally welded. The first inner layer film in the second embodiment has a function of inhibiting the elution of impurities from the medicinal solution in the inner bag.

Regarding the fluorine-containing resin film used for the first inner layer film, it can be set to be the same as that described in the item of "1. First Embodiment Aspects", so the description here is omitted.

The thickness of the first inner layer film is not particularly limited as long as it can suppress the dissolution of impurities in the inner bag into the medicinal solution, and can be appropriately selected according to the use of the packaging bag of the second embodiment and the like. The thickness of the first inner layer film is, for example, in a range of 5 μm to 100 μm, in which a range of 10 μm to 80 μm is preferred, and a range of 10 μm to 50 μm is particularly preferred. The reason is that if the thickness of the first inner layer film is too thin, it may become difficult to laminate with the second inner layer film to form a good film shape. The reason is that the impurities from the second inner layer film may be dissolved in the chemical solution through the first inner layer film. Out. In addition, the reason is that it may become difficult to sufficiently heat-seal the first inner layer films to each other in the heat-sealed portion. The reason is that it may become difficult to form the first inner layer film well. Further, the reason is that if the thickness of the first inner layer film is too thick, it may become difficult to sufficiently thermally weld the first inner layer films to each other, or it may take a long time for the heat fusion. In addition, the reason is that the amount of the fluororesin used is increased, so the cost of the packaging bag of the second embodiment may be increased.

(ii) Second inner layer film

The second inner layer film in the second embodiment is a film including a resin that can be thermally welded at a temperature equal to or lower than the melting point of the above-mentioned fluororesin. The second inner layer film is arranged on the outer bag side. In addition, in the second embodiment, the second inner layer film system and the first outer layer film are usually arranged to face each other and are thermally welded. The second inner layer film in the second embodiment has a function of imparting a predetermined strength to the inner bag in the inner bag, and has a function of thermally welding with the first outer layer film in the outer bag to make the bag body a double structure. When the intermediate bag is provided, the bag body can have a multiple structure.

The resin contained in the second inner layer film is not particularly limited as long as it can be heat-sealed at a temperature equal to or lower than the melting point of the fluorine-containing resin, and the fluorine-containing resin contained in the first inner layer film can be used. The type of resin is appropriately selected. Here, the "temperature equal to or lower than the melting point of the fluororesin" means the above-mentioned "temperature equal to the melting point of the fluororesin" or lower. The heat-welding temperature of the resin contained in the second inner layer film is, for example, preferably 230 ° C. or lower, in which the range of 80 ° C. to 230 ° C. is preferred, and the range of 80 ° C. to 220 ° C. is particularly preferred. When the heat-welding temperature of the resin contained in the second inner layer film exceeds the above value, the load of the outer layer film heating becomes large, so it may become difficult to manufacture the packaging bag itself, or it may be possible The resins that can be used in the outer film are subject to greater restrictions.

The resin contained in the second inner layer film is not particularly limited as long as it can be heat-sealed at a temperature equal to or lower than the melting point of the fluororesin. Examples of such resins include polyolefin resins such as polyethylene (PE) such as LDPE and polyolefin resins such as polypropylene (PP). In addition, modified polyolefins can be used. In addition, as the resin included in the second inner layer film, for example, EVOH can be used. In the second embodiment, polyethylene is preferably used, and ultra-low dissolution polyethylene is more preferably used. The reason for this is that impurities from the second inner layer film can be preferably prevented from being mixed into the chemical solution through the first inner layer film. Examples of the ultra-low dissolution polyethylene include NOVATEC (registered trademark) LD (Japan Polyethylene Co., Ltd.) without addition, and the like.

The thickness of the second inner layer film is not particularly limited as long as it can be laminated with the first inner layer film to form an inner layer film so that an inner bag can be formed. The thickness of the bag according to the second embodiment may be used. The use is appropriately selected. The thickness of the second inner layer film is, for example, in a range of 10 μm to 100 μm, in which a range of 15 μm to 90 μm is preferred, and a range of 20 μm to 80 μm is particularly preferred. The reason is that if the thickness of the second inner layer film is too thin, it may become difficult to laminate with the first inner layer film to form a good film shape. The reason is that it may become difficult to impart sufficient strength to the inner bag. The reason is that if the thickness of the second inner layer film is too thick, it may become difficult to thermally weld the second inner layer film, the first outer layer film, and the first inner layer film to each other. The reason is that the time required for thermal fusion may be large.

(iii) Functional layer for inner film

In the second embodiment, the inner layer film may be formed with a functional layer for the inner layer film between the first inner layer film and the second inner layer film as required. The functional layer for the inner film can be set as above The contents described in the item "I. First Embodiment Aspect" in the functional layer for the outer layer film are the same, so the description here is omitted.

(iv) Inner film

The inner layer film in the second embodiment is a laminated film of the first inner layer film and the second inner layer film. The thickness of the inner layer film is not particularly limited as long as it can impart a predetermined strength to the inner bag, and can be appropriately selected according to the use of the packaging bag of the second embodiment and the like. The thickness of the inner layer film is, for example, in a range of 15 μm to 120 μm, in which a range of 20 μm to 110 μm is preferred, and a range of 30 μm to 100 μm is particularly preferred. The reason is that when the thickness of the inner layer film is too thin, or when it is too thick, the problems described in the item "I. First Implementation Aspect" above may occur.

The method for forming the inner layer film can be the same as the method for forming a general laminated film, and for example, the same method as the method for forming the outer layer film can be used.

The inner layer film may be a laminated film of the first inner layer film and the second inner layer film, or may be a laminated film of the first inner layer film, the functional layer for the inner layer film, and the second inner layer film, thereby reducing the manufacturing cost. From the viewpoint, the former is more preferable.

The combination of the resins included in the first inner layer film and the second inner layer film (resin of the first inner layer film / resin of the second inner layer film) is not particularly limited. For example, EFEP / EVOH, LM are preferred. -ETFE / EVOH. In addition, it is a combination of the resin included in the first inner layer film, the functional layer for the inner layer film, and the second inner layer film (resin of the first inner layer film / resin of the functional layer for inner layer film / second inner layer film). Resin), for example, EFEP / PA6 / modified polyolefin, EFEP / modified polyolefin / LDPE, EFEP / modified polyolefin / LDPE / EVOH / LDPE, LM-ETFE / PA6 / modified polyolefin , LM-ETFE / modified polyolefin / LDPE, LM-ETFE / modified polyolefin / LDPE / EVOH / LDPE, etc. Such The laminated film can be formed using, for example, a coextrusion laminated molding method.

(b) Inner bag

In the second embodiment, the inner bag contains a medicinal solution, and the first inner layer film is arranged on the medicinal solution side in the inner bag, and the second inner layer film is arranged on the outer bag side. That is, a first inner layer film is arranged inside the inner bag, and a second inner layer film is arranged outside the inner bag. The shape of the inner bag is appropriately determined depending on the shape of the packaging bag according to the second embodiment.

(2) Outer bag

In the second embodiment, the outer bag is composed of an outer film. The outer bag is arranged outside the inner bag.

(a) Outer film

In the second embodiment, the outer layer film is a laminated film of the first outer layer film and the second outer layer film. More specifically, in the outer layer film in the second embodiment, one surface of the first outer layer film is laminated and formed into a second outer layer film to form a single film.

(i) First outer film

The first outer layer film in the second embodiment is a film including a resin that can be thermally welded at a temperature equal to or lower than the melting point of the fluororesin. The first outer layer film is arranged on the inner bag side. In addition, in the second embodiment, the first outer layer film and the second inner layer film are usually arranged to face each other and are thermally welded. The first outer layer film in the second embodiment has a function of thermally welding the second inner layer film in the outer bag and the inner bag to make the bag body have a double structure.

The resin contained in the first outer layer film is not particularly limited as long as it can be heat-sealed at a temperature equal to or lower than the melting point of the fluorine-containing resin, and the fluorine-containing resin contained in the first inner layer film can be used. The type is appropriately selected. Regarding the specific heat-welding temperature of the resin contained in the first outer layer film, it can be set to be the same as that described in the item of "(1) inner bag (a) inner layer film (ii) second inner layer film", Therefore, the description here is omitted.

The resin included in the first outer layer film is usually one that can be thermally welded to the resin included in the second inner layer film. As such a resin, the same resin as that contained in the second inner layer film may be used, or a resin different from the resin contained in the second inner layer film may be used. Among them, in the second embodiment, the resin contained in the first outer layer film is preferably the same resin as the resin contained in the second inner layer film. The reason is that the first outer layer film and the second inner layer film can be thermally welded well. The resin film used as the first outer layer film may be the same as the resin film used for the first inner layer film, or may be different from the resin film used for the first inner layer film. Regarding the specific resin used in the first outer layer film, it can be set to be the same as that described in the item "(1) Inner bag (a) Inner layer film (ii) Second inner layer film", and therefore omitted here Description.

The thickness of the first outer layer film is not particularly limited as long as it can be thermally welded to the second inner layer film, and can be appropriately selected according to the use of the packaging bag of the second embodiment and the like. The thickness of the first outer layer film is, for example, in a range of 10 μm to 100 μm, in which a range of 10 μm to 90 μm is preferred, and a range of 15 μm to 80 μm is particularly preferred. The reason is that if the thickness of the first outer layer film is too thin, it may become difficult to sufficiently thermally weld the second inner layer film. The reason is that it may become difficult to form a good film shape by laminating with the second outer layer. The reason is that if the thickness of the first outer layer film is too thick, it becomes difficult to apply heat to the multilayer structure during the production of the packaging bag of the second embodiment. In the thickness direction, it may become difficult to heat-weld the first outer layer film and the second inner layer film, or it may become difficult to heat-weld the first inner layer film to each other. The reason is that the time required for thermal fusion may be large.

(ii) The second outer layer film

The second outer film in the second embodiment is a film that is disposed on the outer side of the bag body and includes a resin having a melting point equal to or higher than the melting point of the fluorine-containing resin. The second outer layer film is disposed on the outer side of the bag body. The second outer film in the second embodiment has a function of imparting a predetermined strength to the outer bag. Regarding the second outer layer film, it can be set to be the same as that described in the item of "I. First Embodiment Aspect", and therefore the description here is omitted.

(iii) Functional layer for outer film

In the second embodiment, the outer layer film may be formed with a functional layer for the outer layer film between the first outer layer film and the second outer layer film as required. The functional layer for the outer layer film may be the same as that described in the item of the functional layer for the outer layer film in the above-mentioned "I. First Embodiment Aspect", and therefore description thereof is omitted here.

(iv) Outer film

In the second embodiment, the outer layer film is a laminated film of the first outer layer film and the second outer layer film. The thickness of the outer layer film is not particularly limited as long as it can impart a predetermined strength to the outer bag, and can be appropriately selected according to the use of the packaging bag of the second embodiment and the like. The thickness of the outer layer film is, for example, in a range of 20 μm to 120 μm, and preferably in a range of 20 μm to 100 μm, and particularly preferably in a range of 30 μm to 80 μm. The reasons are: When the thickness of the outer layer film is too thin, or when it is too thick, the problems described in the item "I. First Implementation Aspect" above may occur.

The method for forming the outer layer film is not particularly limited as long as the first outer layer film and the second outer layer film can be laminated to form the outer layer film. Regarding the specific method of forming the outer layer film, it may be the same as that described in the item "(1) Inner bag (a) Inner layer film (iii) Inner layer film".

(b) Outer bag

In the second embodiment, the outer bag is disposed outside the inner bag, and protects the inner bag from impact, friction, and the like from the outside of the packaging bag of the second embodiment. In the outer bag, a first outer layer film is arranged on the inner bag side, and a second outer layer film is arranged on the outer side of the bag body.

The form of the outer bag is appropriately determined depending on the form of the packaging bag according to the second embodiment. In the second embodiment, the outer bag is preferably arranged so as to cover the inner bag. The reason is that the inner bag can be better protected.

(3) Intermediate bag

The packaging bag according to the second embodiment is preferably the bag body and further includes an intermediate bag disposed between the inner bag and the outer bag and composed of an intermediate film, and the multi-layer structure in the heat-welded portion has the inner layer superposed thereon. Film, the intermediate film, and the outer layer film. The intermediate film includes a resin that can be thermally welded at a temperature equal to or lower than the melting point of the fluororesin. In the second embodiment, the strength of the packaging bag can be made higher by having an intermediate bag.

The resin used for the interlayer film is not particularly limited as long as it is a resin that can be heat-sealed at a temperature equal to or lower than the melting point of the above-mentioned fluorine-containing resin. It can be selected and used from the resins described in the item "(1) Inner bag (a) Inner layer film (ii) Second inner layer film", so the explanation here is omitted. The thickness of the intermediate film may be the same as the thickness of the inner film described in the item (1) Inner bag (a) Inner film (iii) Inner film. Instructions.

The intermediate film may have, for example, a functional layer for an intermediate film. The intermediate film is a resin that can be thermally welded to the second inner layer film on the innermost side of the inner bag side, and a resin that can be thermally welded to the first outer layer film on the outermost side of the outer bag side. The functional layers for the intermediate film, the layer structure of the intermediate film, and the number of the intermediate bags can be set to be the same as those described in the item "I. First Embodiment Aspects", and therefore descriptions thereof are omitted here.

(3) Heat-welded part and bag body

Regarding the heat-welded portion and the bag body, the same contents as described in the item of "I. First Embodiment Aspect" can be used, so the description here is omitted.

2. Injected components and other components

The injecting member in the second embodiment is the one connected to the bag body. Regarding the injection member and other structures, the same contents as described in the item of "I. First Embodiment Aspect" can be used, so the description here is omitted.

3.packing bag

The manufacturing method of the packaging bag according to the second embodiment is not particularly limited, and may be the same as the manufacturing method of a general packaging bag. Specifically, it can be set to be the same as the manufacturing method of the packaging bag described in "I. 1st aspect." In the second embodiment, it is preferable that the first inner layer film side of the inner layer film is washed before the formation of the heat-welded portion. its The reason is that it can reduce particles and the like attached to the drug solution side of the inner bag in the second embodiment, and it is easy to dry the first inner layer film after washing.

III. Third embodiment

The packaging bag for storing a medicinal solution according to a third embodiment is characterized in that the inner layer film includes a first inner layer film disposed on the medicinal solution side, a second inner layer film disposed on the outer bag side, and an arrangement thereof. The laminated film of the functional layer for the inner layer film between the first inner layer film and the second inner layer film, the first inner layer film and the second inner layer film contain fluorine containing a melting point of 230 ° C. or lower A film of a resin, and the film for thermal fusion in the outer layer film is a film containing a fluorine-containing resin having a melting point of 230 ° C or lower.

According to the third aspect, since the first inner layer film is a fluorine-containing resin film, the elution of impurities into the chemical solution can be suppressed. In addition, since the second inner layer film and the first outer layer film are fluorine-containing resin films having a predetermined melting point or lower, the inner layer film and the outer layer film can be thermally welded at a relatively low temperature.

The thickness of the first inner layer film, the functional layer for the inner layer film, and the second inner layer film can be appropriately selected according to the use of the packaging bag. The combination of the first inner layer film, the functional layer for the inner layer film, and the resin used for the second inner layer film as the third embodiment (resin of the first inner layer film / resin for the functional layer for the inner layer film) / Resin of the second inner layer film) include, for example, EFEP / polyimide (PI) / EFEP, LM-ETFE / PI / LM-ETFE, and the like. The functional layer for the inner layer film may be the same as that described in the item "II. Second Embodiment Aspects". In addition, it is possible to make it the same as the packaging bag of "I. 1st embodiment aspect" about the point other than the above.

B. Container for medicinal solution storage

The medicinal solution storage container of the present invention includes an outer container and a medicinal solution storage packaging bag arranged in the outer container, characterized in that the medicinal solution storage packaging bag is the above-mentioned "A. medicinal solution storage packaging bag" "The medicinal solution storage packaging bag described in the item".

That is, the medicinal solution storage container of the present invention includes an outer container and a medicinal solution storage packaging bag arranged in the outer container, wherein the medicinal solution storage packaging bag has a bag body and has a inner portion. An inner bag formed of a layered film and containing a medicinal solution, and an outer bag formed of an outer layered film and arranged on the outer side of the inner bag; and an injection member that is connected to the bag body, and the inner bag and the outer bag have overlapping The multilayer structure formed by the inner layer film and the outer layer film is a heat-sealed portion which is welded in a state where the inner layer films are opposed to each other, and the inner layer film has a melting point of 230 on the outermost surface of the chemical liquid side. For a fluorine-containing resin film below ℃, the outer layer film is a laminated film having a first outer layer film disposed on the inner bag side and a second outer layer film disposed on the outer side of the bag body, and the first outer film system A film for thermal fusion bonding that can be thermally welded to the inner layer film, and the second outer layer film includes a resin having a melting point equal to or higher than the melting point of the fluorine-containing resin of the inner layer film.

16 and 17 are schematic cross-sectional views showing one example and another example of a container for storing a medicinal solution according to the present invention. As shown in FIGS. 16 and 17, the medicinal solution storage container 4 includes an outer container 5 and a medicinal solution storage packaging bag 1 arranged in the outer container 5. FIG. 15 shows an example of a packaging bag for storing a medicinal solution in a first embodiment, and FIG. 16 shows an example of a packaging bag for storing a medicinal solution in a second embodiment. The packaging solution 1 for medicinal solution storage can be the same as that described in FIGS. 1 to 3 and 13 to 15, and therefore description thereof is omitted here. 16 and 17 show an example in which the outer container 5 is a metal can, and the container body 51, a gas supply unit 52 for supplying nitrogen and the like to the container body 51, and a note 1 for storing a medicinal solution packaging bag Out An example in which the member 3 is fixed to the fixing portion 53 of the container body 51.

According to the present invention, the medicinal solution storage packaging bag described above can be used as a medicinal solution storage container capable of suppressing the impurities in the inner bag in the medicinal solution storage pack from dissolving into the medicinal solution. Hereinafter, the details of the medicinal solution storage container of the present invention will be described.

1.Packaging bag for medicinal solution storage

The packaging bag for storing a medicinal solution in the present invention is one arranged in an outer container. The details of the packaging bag for storing a medicinal solution in the present invention may be the same as those described in the item "A. Packaging bag for storing a medicinal solution", and therefore description thereof is omitted here.

2. Outer container

In the present invention, the outer container is the one in which the packaging bag for storing a medicinal solution is arranged on the inner side. The outer container usually includes a container main body in which a packaging bag for storing a medical solution is disposed and holds the medical solution, and a fixing portion for fixing an injection member in the packaging bag for storing a medical solution. Moreover, as an outer container, as shown in FIG. 16, the gas supply part 52 which supplies nitrogen etc. to the inside of the container main body 51 may be provided.

The outer container may be the same as a user of a general medicinal solution storage container, and examples thereof include outer containers made of metal, synthetic resin, and paper. More specifically, examples of the outer container include a metal can, a polyethylene bottle, and a corrugated cardboard case.

3. Container for medicinal solution storage

The medicinal solution storage container of the present invention has only the above-mentioned outer container and a medicinal solution storage The packaging bag is not particularly limited, and other components may be appropriately selected and added as necessary.

Moreover, when the medicinal solution filled in the medicinal solution packaging bag is taken out of the medicinal solution storage container of the present invention, the medicinal solution can be taken out by applying pressure from the outside of the medicinal solution packaging bag. FIG. 18 is an explanatory diagram for explaining a method for taking out a chemical solution (injection method) in a container for storing a chemical solution of the present invention. In the method for pouring the medicinal solution L in the medicinal solution storage container 4 of the present invention, the nozzle G is used to supply nitrogen gas G from the gas supply unit 52 to the inside of the container body 51. The nitrogen gas G supplied to the inside of the container body 51 applies a pressure to the medicinal solution storage packaging bag 1 from the outside. With this pressure, the medicinal solution L filled in the medicinal solution storage packaging bag 1 is squeezed out of the medicinal solution storage packaging bag 1 through the nozzle 62 to take out the medicinal liquid L. It should be noted that the symbols not described in FIG. 18 may be the same as the symbols described in FIG. 16 and the like, and thus descriptions thereof are omitted.

The present invention is not limited to the embodiments described above. The above-mentioned embodiment exemplifies that a person having substantially the same configuration as the technical idea described in the patent application scope of the present invention and exhibiting the same function and effect is also included in the technical scope of the present invention.

[Example]

The details of the packaging bag of the present invention will be described below with examples and comparative examples.

[Example 1] <Heat-weldability test of fluororesin film>

As the outer layer film, a laminated film composed of a first outer layer film, a functional layer for an outer layer film, and a second outer layer film each composed of LM-ETFE, PE, and PBT was used. Also, use LM-ETFE As an inner layer film. The multiple layers of the above-mentioned outer layer film and inner layer film are superimposed so that the inner layer film faces the side facing each other, and it is performed at 230 ° C. under a welding time of 10 seconds, a welding pressure of 0.1 MPa, and two welding times. Thermal fusion, whereby a double pouch can be formed. In addition, using a tensile tester, the adhesive strength of the heat-sealed portion of the double pouch was measured under the above conditions. As a result, it was confirmed that the adhesive strength was 25 N / 15 mm or more.

[Example 2]

As the outer layer film, a laminated film composed of a first outer layer film and a second outer layer film made of PE and PBT, respectively. Further, as the inner layer film, a laminated film composed of a first inner layer film and a second inner layer film each of LM-ETFE and PE was used. The multilayer structure in which the above-mentioned outer layer film and the inner layer film were superimposed was arranged so that the inner layer film side faced, and was performed at 230 ° C. under a welding time of 10 seconds, a welding pressure of 0.1 MPa, and two welding times. Thermal fusion, whereby a double pouch can be formed. In addition, using a tensile tester, the adhesive strength of the heat-sealed portion of the double pouch was measured under the above conditions. As a result, it was confirmed that the adhesive strength was 25 N / 15 mm or more.

[Comparative example]

PTFE, PFA, FEP, and ETFE cannot form a laminated film with other resins, and are difficult to use as an inner film.

[Reference Example 1] <Dissolution test of impurities in fluororesin film>

Cut out 25 from various fluororesin films of PTFE (thickness 100 μm), PFA (thickness 50 μm), FEP (thickness 50 μm), ETFE (thickness 50 μm), LM-ETFE (thickness 25 μm) Nine pieces of a film having a size of 100 mm × 100 mm were immersed in 13 mL of dimethyl carbonate (DMC) as a solvent for an electrolyte solution for a lithium ion battery and left to stand at 60 ° C. for one week. Thereafter, it was confirmed whether a component derived from the fluororesin film was eluted from the film to a solvent using a gas chromatography mass spectrometer (manufactured by Shimadzu Corporation, product name: GCMS-QP2010). The conditions are the same as in Reference Example 3 described below. In any of the fluororesin films, no component peak derived from the fluororesin was detected from a chromatogram obtained by a gas chromatography mass spectrometer.

[Reference Example 2] <Heat-weldability test of fluororesin film>

Two pieces of each fluororesin film (PTFE, PFA, FEP, ETFE, PCTFE, LM-ETFE) were heat-sealed at 230 ° C in an overlapped state, and the presence or absence of heat fusion was confirmed. Under the conditions of welding time of 10 seconds, welding pressure of 0.1 MPa, and welding times of 2 times, PTFE, PFA, FEP, and ETFE are not thermally welded, but PCTFE and LM-ETFE are thermally welded. Using a tensile tester, the adhesion strength of the PCTFE and LM-ETFE films was measured under the above conditions, and the results showed that it was 25N / 15mm or more.

[Reference Example 3] <Residual film elution test of resin film>

The following samples were subjected to a dissolution test of impurities. A PTFE film (thickness: 100 μm) was used as Sample 1 and an LM-ETFE film (thickness: 50 μm) was used as Sample 2. As a sample 3, a laminated product in which a two-layer laminated film (thickness: 100 μm) of LM-ETFE and ultra-low dissolution PE was thermally fused to the ultra-low dissolution PE surface was used. As the sample 4, an ultra-low-dissolution PE film (thickness: 80 μm) was used, and as the sample 5, a normal PE film (thickness: 50 μm) was used. again For the ultra-low-dissolution PE film, NOVATEC LD (Japan Polyethylene Co., Ltd.) without inflation is used to form a film. As a normal PE film, Umerit 125FN (UBE-MARUZEN POLYETHYLENE Corporation) ) Inflated into a film.

For the above-mentioned samples 1, 2, 4, and 5, several strip-shaped samples were sampled so as to have a total volume of 600 ^mm3 , immersed in 4 mL of dimethyl carbonate (DMC), and left to stand at 60 ° C for one week. For sample 3, a number of strips were sampled so that the total volume was 400 mm ³ , immersed in 4 mL of dimethyl carbonate (DMC), and allowed to stand at 60 ° C. for one week. Similarly, for the above samples 1, 2, 4, and 5, a plurality of strips were sampled so as to have a total volume of 600 mm ³ , and for the sample 3, several strips were sampled so as to have a total volume of 400 mm ³ , It was immersed in 4 mL of propylene glycol-1-monomethyl ether acetate (PGMEA) and left to stand at 60 ° C for 1 week to prepare an eluate from each sample.

Thereafter, each solution was analyzed using a gas chromatography mass spectrometer (manufactured by Shimadzu Corporation, product name: GCMS-QP2010). For gas chromatography, 1 μL of the eluate was introduced into the gasification chamber. The heating conditions of the gasification chamber were set to 300 ° C. The column is a column with a length of 30m, an inner diameter of 0.25mm, and a stationary phase (equivalent to dimethylsiloxane 95% phenyl 5%) 0.25. Regarding the heating conditions of the column oven, the measurement was performed after the temperature was maintained at 50 ° C for 5 minutes, and then the temperature was increased to 320 ° C at 10 ° C / min, and then held at 320 ° C for 8 minutes. The results are shown in Table 1 and FIGS. 19 and 20. Table 1 is a table showing the peak intensity of alkane (olefin) detected near the dissolution time of 15.88 min. Figure 19 and Figure 20 show the results of gas chromatography mass spectrometry. In Table 1, FIG. 19, and FIG. 20, the sample 3 is expressed by a conversion value converted into a total volume of 600 ^mm3 , and indicates a value in a case where the total volume of each sample is the same.

[Table 1]

As shown in Table 1, FIG. 19, and FIG. 20, with respect to any of the solvents of DMC and PGMEA, no peaks of impurities were observed in Samples 1 and 2. On the other hand, regarding samples 3 and 4, a peak of an alkane (olefin) was confirmed at a dissolution time of 15.88 min. Therefore, it can be considered that the eluted amount of impurities is a relationship of PTFE ≒ LM-ETFE <LM-ETFE / ultra-low dissolution PE <ultra-low dissolution PE <(normal PE). With regard to sample 3, although some dissolution was found, the detection intensity was lower than that of sample 4. The reason is speculated that the LM-ETFE with the position of sample 3 on the surface side inhibits the dissolution of PE from the position of sample 3 with the main body. From this result, it was confirmed that the elution of impurities from the low-leaching PE film positioned inside the laminated film was suppressed. That is, when the above-mentioned laminated film is used for the inner bag, it can be confirmed that the elution of impurities can be suppressed compared with the case where the ultra-low dissolution film is used for the inner bag. Moreover, when only an LM-ETFE film was used for the inner bag, it was confirmed that the elution of impurities can be more effectively suppressed.

Claims (6)

A packaging bag for storing a medicinal solution, comprising: an inner bag composed of an inner layer film and containing the medicinal solution; and a bag body composed of an outer layer film and disposed on an outer bag outside the inner bag, and the bag The injection member connected to the body is characterized in that the inner bag and the outer bag have a heat-sealed portion, which is a multilayer structure formed by overlapping the inner layer film and the outer layer film so that the inner layer film overlaps with each other It is welded in this state. The inner layer film has a film containing a fluorine-containing resin having a melting point of 230 ° C. or lower on the outermost surface of the drug solution side. The outer layer film has a first outer layer film disposed on the inner bag side. A laminated film with a second outer layer film disposed on the outer side of the bag body, the first outer layer film is a heat-sealing film that can be thermally welded to the inner layer film, and the second outer layer film includes the inner layer and the inner layer. The above-mentioned fluorine-containing resin is a film of a resin having a melting point equal to or higher than the melting point. For example, the medicinal solution storage packaging bag of claim 1, wherein the inner layer film includes only the film containing the above-mentioned fluororesin, and the first outer layer film includes a fluorine-containing film having a melting point of 230 ° C or lower. Resin film. For example, the medicinal solution storage packaging bag according to claim 2, wherein the bag body further includes an intermediate bag disposed between the inner bag and the outer bag and composed of an intermediate film, and the multilayer structure in the heat-welded portion has The inner layer film, the intermediate film, and the outer layer film are overlapped, and the intermediate film has a film containing a fluorine-containing resin having a melting point of 230 ° C. or lower. The medicinal solution storage packaging bag according to claim 1, wherein the inner layer film is a first inner layer film having a fluorine-containing resin disposed on the side of the medicinal solution and containing a melting point of 230 ° C or lower, and the outer bag is disposed in the outer bag. A laminated film including a second inner layer film of a resin that can be thermally welded at a temperature equal to or lower than the melting point of the above fluororesin, and the above-mentioned film for thermal fusion in the outer layer film includes Film of a fluororesin that is thermally welded at a temperature equal to or lower than the melting point. The medicinal solution storage packaging bag according to claim 4, wherein the bag body further includes an intermediate bag disposed between the inner bag and the outer bag and composed of an intermediate film, and the multi-layer structure in the heat-sealed portion has The inner layer film, the intermediate film, and the outer layer film are overlapped, and the intermediate film is a film including a resin that can be thermally welded at a temperature equal to or lower than the melting point of the fluororesin. A medicinal solution storage container includes an outer container and a medicinal solution storage packaging bag arranged in the outer container. The medicinal solution storage packaging bag has a bag body and an inner layer. An inner bag made of a film and containing a medicinal solution, and an outer bag made of an outer film and arranged on the outer side of the inner bag; and an ejection member that is connected to the bag body; the inner bag and the outer bag have heat-welded portions It is a multilayer structure formed by overlapping the inner layer film and the outer layer film in a state where the inner layer films overlap with each other, and the inner layer film has a melting point including the melting point on the outermost surface of the chemical liquid side. The film is a fluorine-containing resin at 230 ° C or lower. The outer film is a laminated film having a first outer film disposed on the inner bag side and a second outer film disposed on the outer side of the bag body. The first outer layer is The film is a film for thermal welding that can be thermally welded to the inner layer film, and the second outer layer film is a film including a resin having a melting point equal to or higher than the melting point of the fluorine-containing resin of the inner layer film.