JP2011110369A - Medical container - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical container suppressing elution of an adhesive to a medicinal solution. <P>SOLUTION: The medical container includes an inner layer composed of a cyclic olefin resin, the inner layer being adhered to an adjacent layer by use of an adhesive, and an intermediate layer provided adjacently to the inner layer without adhesion, the intermediate layer being formed of a resin which is different from the cyclic olefin resin and has good adhesiveness to the cyclic olefin resin. The intermediate layer is adhered to an outer layer by use of the adhesive. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a medical container that suppresses the influence of elution on the contents of an adhesive.

  Conventionally, a glass container has been used as a container for storing a drug and a drug solution. On the other hand, in recent years, a resin container has been desired from the viewpoint of disposal and lightness.

  However, when a drug and a chemical solution are stored with a typical resin material such as polyethylene (PE) or polypropylene (PP) as a single layer or an innermost layer, a highly adsorbable drug such as nitroglycerin is used in a container (PE Or PP) may cause the drug to be adsorbed, resulting in a decrease in active ingredients or insoluble components in the container.

In addition, compared with glass, resin is poor in gas barrier properties, and there is concern about the influence on chemicals and chemicals.
Accordingly, containers using cyclic olefins have been developed as containers having low drug adsorption, good chemical resistance such as acid resistance, alkali resistance and boiling water resistance, and good transparency.

  For example, Patent Document 1 describes a multilayer container using a cyclic olefin layer and a gas barrier resin layer as a container having transparency, chemical resistance, gas barrier property, and water vapor permeability. Patent Document 2 discloses that an oxygen-absorbing resin layer containing an oxidizing polymer and a transition metal-based oxidation catalyst is used as an intermediate layer and sandwiched between an oxygen-barrier resin and / or an oxygen-barrier vapor-deposited layer. It describes an oxygen-absorbing container that prolongs the oxygen-absorbing performance of the absorbent resin layer.

  Patent Document 3 describes a packaging material having excellent gas barrier properties in which an oxygen-absorbing resin layer mainly composed of a polyolefin resin containing an oxygen absorbent and a gas barrier resin layer mainly composed of a cyclic polyolefin resin are laminated. Has been. Furthermore, Patent Document 4 describes a structure having a high gas barrier property by being composed of an ethylene-vinyl alcohol copolymer (EVOH) layer and a cyclic olefin layer.

JP-A-4-276253 Japanese Patent Laid-Open No. 2002-240813 Japanese Patent Laid-Open No. 2007-111982 WO96 / 01184 Publication

  The ethylene-vinyl alcohol copolymer (EVOH) has a high gas barrier property, but the gas barrier property depends on humidity, and the gas barrier property decreases as the humidity increases. On the other hand, since the cyclic olefin resin is excellent in water vapor barrier resistance, EVOH can be kept in a low humidity state by sandwiching EVOH with the cyclic olefin as described in the cited document 4, and a good gas barrier is obtained. Can keep sex.

  However, EVOH has poor adhesion to other resins, and there is a problem that it peels easily unless an adhesive layer is provided between both layers. However, when an adhesive is used in a medical container or the like, there is a concern that the adhesive component may elute into the chemical solution stored in the container. Further, the cyclic olefin has a high rigidity, and there is a problem that when the thickness is increased to suppress elution of the adhesive, the container is easily damaged.

  Therefore, an object of the present invention has been made in view of the above problems, and is to find a medical container capable of suppressing the elution of an adhesive into a chemical solution.

  In order to solve the above-mentioned problems, the present inventors have intensively studied to overcome the problems of the above-described conventional techniques. As a result, the inventors have an inner layer made of a cyclic olefin-based resin, and use an adhesive with an adjacent layer. A medical container formed by adhering to the inner layer without using an adhesive and having an intermediate layer made of a resin different from the cyclic olefin resin and made of a resin having good adhesion to the cyclic olefin resin. And it discovered that the elution to the chemical | medical solution of an adhesive agent can be suppressed by adhere | attaching an intermediate | middle layer and an outer layer using an adhesive agent. The present invention has been made based on these findings.

  That is, according to the present invention, there is provided a medical container having an inner layer made of a cyclic olefin resin and bonded to an adjacent layer using an adhesive, and adjacent to the inner layer without using an adhesive. And having an intermediate layer made of a resin different from the cyclic olefin resin and made of a resin having good adhesion with the cyclic olefin resin, and bonding the intermediate layer and the outer layer using an adhesive. The medical container which can suppress the elution to the chemical | medical solution is provided.

  The intermediate layer of the medical container of the present invention is preferably a resin having a rigidity lower than that of the cyclic olefin resin.

  The outer layer of the medical container of the present invention is preferably made of EVOH.

  Moreover, it is preferable that the intermediate | middle layer of the medical container of this invention is comprised by several resin layers.

  The intermediate layer of the medical container of the present invention preferably includes a cyclic olefin resin on the outer layer side and a resin different from the cyclic olefin resin on the inner layer side and a resin having good adhesion to the cyclic olefin resin.

  Further, the resin different from the cyclic olefin resin of the medical container of the present invention and having good adhesiveness with the cyclic olefin resin is preferably a polypropylene resin containing a styrene elastomer.

  According to the present invention, it is possible to provide a medical container capable of suppressing the elution of an adhesive into a chemical solution.

It is a block diagram of the medical container in the 1st Embodiment of this invention. It is a figure which shows the adhesive agent concentration gradient of the layer which suppresses elution of the adhesive agent in one Embodiment of this invention. It is a block diagram of the medical container produced by the blow molding which concerns on embodiment of this invention.

  Hereinafter, a medical container according to an embodiment of the present invention will be described in detail with reference to the drawings.

(First embodiment)
FIG. 1 is a configuration diagram of a medical container according to the first embodiment of the present invention. The medical container 1 includes an outer layer 2, an intermediate layer 4, and a cyclic olefin resin layer 5 with an adhesive layer 3 interposed therebetween.

  The medical container 1 in the present embodiment includes a cyclic olefin-based resin in the inner layer, and can suppress the adsorption of the drug contained in the drug solution. In addition, the chemical | medical agent adsorption | suction from the accommodated chemical | medical solution can be suppressed favorably by making the cyclic olefin resin layer 5 into an inner layer, especially an innermost layer.

  Moreover, the medical container 1 in this embodiment is provided with the discharge port part 11 for discharging | emitting the stored chemical | medical solution, the suspension part 12 for suspending the medical container 1, and the trunk | drum 13.

  Further, in order to use the medical container 1 in the present embodiment, a rubber stopper is welded to the discharge port portion 11, a bottle needle with an infusion tube is punctured into the rubber stopper, and the hanging portion 12 is used as an infusion stand or the like. And the discharge port 11 is placed on the lower side. The medicinal solution stored in the medical container 1 flows into the infusion tube through the punctured bottle needle, is discharged from the medical container 1, and is introduced into the living body through the intravenous injection needle or the indwelling needle. The barrel portion 13 has flexibility, and even when the amount of the chemical solution in the container is reduced, the barrel portion 13 contracts, whereby an internal pressure can be applied in the vicinity of the discharge port, and the discharge amount of the chemical solution Can be suppressed from decaying according to the remaining amount of the chemical.

(Cyclic olefin resin layer)
The cyclic olefin used in the cyclic olefin-based resin layer 5 is a known substance (Japanese Patent Laid-Open No. 4-276253), and a polymer obtained from a cyclic olefin by a known ring-opening polymerization method and hydrogenated by a conventional hydrogenation method. It is a saturated polymer obtained by addition. These cyclic olefins can be obtained on the market. Among these, from the viewpoint of heat resistance and sterilization treatment, the glass transition temperature is preferably 115 ° C or higher, more preferably 120 ° C or higher. The cyclic olefin-based resin layer 5 has a high rigidity, and if it is too thick, the container is likely to be damaged. Moreover, since it will be easy to produce a local fracture surface when too thin and the chemical | medical agent low adsorption effect will become small, it is preferable that it is 5 micrometers or more.

(Middle layer)
The intermediate layer 4 is composed of, for example, a polyolefin resin layer. By providing the intermediate layer 4 between the adhesive layer 3 and the cyclic olefin-based resin layer 5, it is possible to suppress elution of the adhesive into the chemical solution and supplement the water vapor barrier property. With this configuration, elution of moisture by the contents can be suppressed, so that the humidity in the EVOH resin layer constituting the outer layer 2 can be kept low, and the gas barrier performance of EVOH can be kept good. In addition, a resin that is bonded to the cyclic olefin-based resin layer 5 without using an adhesive is used for the intermediate layer 4. Examples of such a resin include linear low density polyethylene (LLPE). Here, an example has been given for the case where a polyolefin resin is used as the intermediate layer. It ’s fine. Further, a resin having high transparency is more preferable so that the contents can be visually recognized. The light transmittance at this time is preferably 55% or more over the entire visible light region (wavelength 400 to 700 nm) as a multilayer laminate. More preferably, it is 75% or more. Here, the light transmittance is a value measured with a spectrophotometer using air as a control.

  In addition, the thickness of the intermediate | middle layer 4 should just be sufficient thickness which can suppress the elution to the chemical | medical solution of the adhesive bond layer 3. Thereby, in combination with the water vapor barrier property in the cyclic olefin-based resin layer 5, the water vapor permeation from the chemical solution to the EVOH resin layer can be sufficiently prevented, and the gas barrier performance of the EVOH can be kept good for a long time.

  Moreover, as a polyolefin-type resin, a melting | fusing point is 121 degreeC or more from a viewpoint of heat resistance and a sterilization process (121 degreeC, 30 minutes).

  Further, the intermediate layer 4 has, for example, a filler such as silica, a pigment, a dye, a heat stabilizer, a light stabilizer, and the like as long as the properties as a container, particularly mechanical strength (impact resistance) and transparency are not impaired. Contains one or more additives used in the field, such as plasticizers, antistatic agents, flame retardants, flame retardants, anti-aging agents, UV absorbers, antioxidants, anti-fogging agents, lubricants, etc. You may do it.

  Note that transparent containers are particularly in demand in the pharmaceutical and food fields, but pharmaceuticals have substances that are unstable to light, and when filling such pharmaceuticals, coloring agents, titanium oxide, etc. It is optional to add the shading agent.

  Moreover, although the resin between the adhesive layer 3 and the cyclic olefin resin layer 5 has been described as a polyolefin resin here, the synthesis is lower than that of the cyclic olefin resin without using an adhesive. Any resin that can be bonded to a cyclic olefin resin can be used without particular limitation.

(Outer layer)
The outer layer 2 is composed of, for example, an ethylene-vinyl alcohol copolymer (EVOH) resin layer having gas barrier properties. Further, one or more resin layers may be provided on the outer layer.

(Adhesive layer)
As the adhesive layer 3, any adhesive known in the field can be used as long as it can adhere to another adjacent resin.

  As a method for obtaining the above-mentioned multilayer sheet, known methods for laminating each layer such as dry lamination, extrusion coating, coextrusion lamination (T-die method, inflation method), heat lamination, or a lamination method combining these methods are known. This method can be used. Alternatively, a method may be used in which each resin is dissolved in a solvent, applied as a solution and dried.

  In addition, as a method for producing a medical container having the above layer structure, a sheet forming method such as vacuum forming or pressure forming, a blow forming method such as multi-layer coextrusion blow molding, or between multilayer films cut into a predetermined shape Various molding methods such as a method of creating a bag or the like by bonding the peripheral portion with heat fusion or an adhesive can be adopted, and the present invention is not limited to these.

  FIG. 2 is a diagram showing an adhesive concentration gradient of a layer that suppresses elution of the adhesive in an embodiment of the present invention. The vertical axis represents the adhesive component concentration, and the horizontal axis represents time.

  Between the adhesive layer composed of the inner layer adhesive and the innermost cyclic olefin resin layer in contact with the chemical solution, a layer (for example, a linear low density polyethylene layer) for suppressing elution of the adhesive component, Assume a case where it is installed with a certain thickness determined by the chemical solution to be stored.

  Here, the concentration of the adhesive component in the adhesive layer is 100%, but since the layer for preventing elution has a thickness, it takes time to diffuse the adhesive component. Even if the adhesive component reaches the innermost cyclic olefin resin layer, it takes more time to diffuse the cyclic olefin resin layer. Therefore, it is sufficient to provide the layer for suppressing the elution of the adhesive component so that the adhesive component does not diffuse to the innermost layer within the effective period of the chemical solution to be contained. At the same time, the layer for suppressing the elution of the adhesive component also prevents the permeation of water vapor, so that the water vapor permeates from the chemical solution toward the outer layer side and the humidity of the EVOH layer provided in the outer layer is prevented from increasing. be able to. Further, unlike the case where the adhesive component and water vapor are barriered by the cyclic olefin single layer, the rigidity can be kept good, and the container can be prevented from being easily damaged. Moreover, in the case of a medical bag shape, since it has each said barrier property and can maintain the softness | flexibility of the trunk | drum 13 favorably, it can prevent the drainage fall when the content decreases. it can.

(Second Embodiment)
Further, the adhesive may not be provided as a layer by mixing the adhesive with the EVOH resin. According to this embodiment, the layer configuration can be reduced, and the moldability can be improved. On the other hand, since the gas barrier property may be lowered by adding an adhesive component or a modifier to EVOH, it is preferable to appropriately adjust the amount to be added.

(Third embodiment)
In the present embodiment, a plurality of layers are provided between the adhesive layer 3 and the cyclic olefin-based resin layer 5.

  The plurality of layers provided between the adhesive and the cyclic olefin-based resin are made of a resin capable of bonding adjacent layers without using an adhesive. Such a plurality of layers can be constituted, for example, from the inner layer to cyclic olefin resin / linear low density polyethylene (LLPE) / high density polyethylene (HDPE) / adhesive. Further, the plurality of layers provided between them can be used without any particular limitation as long as they have lower rigidity than the resin used for the cyclic olefin-based resin layer 5.

  EXAMPLES Next, although an Example demonstrates this invention further in detail, this invention is not limited to these Examples.

[Example 1]

  FIG. 3 is a configuration diagram of a medical container produced by blow molding.

  The medical container 20 is an intermediate layer with a cyclic olefin resin layer 23 and an adhesive layer 24 adjacent to a polypropylene resin layer 22 to which a styrene elastomer is added as an outermost layer without an adhesive layer. An EVOH resin layer 25 having gas barrier properties, and an intermediate layer of the EVOH resin layer 25 with a cyclic olefin-based resin layer 27 via an adhesive layer 26 and a styrene-based elastomer adjacent to each other without an adhesive layer. It is based on a multilayer configuration in which the added polypropylene resin layer 28 and the cyclic olefin resin layer 29 are provided adjacent to each other without an adhesive layer, and the cyclic olefin resin is used as the innermost layer. It is possible to prevent drug adsorption from the chemical solution.

  The total thickness of the medical container 20 is 500 μm. As the constitution of the thickness of each resin layer, the outermost polypropylene resin layer 22 is 25%, the cyclic olefin resin layer 23 is 7%, the adhesive layer 24 is 3%, the EVOH resin layer 25 is 15%, The adhesive layer 26 is 3%, the inner cyclic olefin resin layer 27 is 7%, the polypropylene resin layer 28 is 35%, and the innermost cyclic olefin resin layer 29 is 5%.

  The polypropylene-based resin layer 22 and the polypropylene-based resin layer 28 are each formed by adding a styrene-based elastomer so that the adjacent cyclic olefin-based resin and the adhesive can be bonded without using an adhesive. Moreover, since the transparency of a polypropylene resin layer can be improved by adding a styrene-type elastomer, the transparency of the whole medical container 20 is improved, and the light transmittance is 80%. .

  In addition, since the flexibility is improved by adding a styrene-based elastomer, there is flexibility even at a similar thickness compared to the case where it is not added, and it is possible to improve the drainage in the bag shape and to prevent damage due to dropping. Become.

  In addition, polypropylene resin has better transparency and higher heat resistance than polyethylene resin, and can withstand high temperature sterilization.

  The polypropylene resin preferably has a melting point of 121 ° C. or higher from the viewpoint of heat resistance and sterilization treatment (121 ° C., 30 minutes), and is a known resin used for medical use or food packaging. If there is, it can be used without any particular limitation.

  Moreover, the styrene elastomer added to the polypropylene resin is obtained by sequentially polymerizing a polystyrene block component and a polybutadiene component, and is not particularly limited and can be obtained on the market. By adding a styrene elastomer to the polypropylene resin, the adhesion to the cyclic olefin resin layer is improved and the transparency of the polypropylene resin is increased.

  Examples of styrene elastomers include hydrogenated styrene butadiene rubber (HSBR), styrene / ethylene butylene / crystalline olefin block copolymer (SEBC), styrene / ethylene butylene / styrene block copolymer (SEBS), and styrene / ethylene propylene. -Styrene block copolymer (SEPS), styrene-butadiene rubber (SBR), styrene-butadiene-styrene block copolymer (SBS), etc. can be mentioned. The styrene elastomer is more preferably one that is uniformly and finely dispersed in the polypropylene resin. More preferably, those finely dispersed (several tens of nanometers) in the nano order are preferable. Adhesiveness and transparency can be further improved by uniformly finely dispersing the styrene elastomer.

  And the addition amount of a styrene-type elastomer is 1 to 50% with respect to a polypropylene resin, Preferably, it is 10 to 30%. If the amount added exceeds 50%, it becomes too soft and the melting point of the resin layer becomes too low, which is not preferable. On the other hand, if the addition amount is less than 1%, adhesion and transparency are insufficient, which is not preferable.

  The mass average molecular weight of the styrene elastomer is preferably in the range of 100,000 to 200,000. When the mass average molecular weight is less than 100,000, mechanical strength such as tensile breaking strength and tensile breaking elongation is deteriorated, and when the mass average molecular weight exceeds 200,000, transparency tends to be deteriorated.

  Further, by providing the cyclic olefin resin layers 23 and 27 adjacent to each other on both sides of the EVOH resin layer 25 through an adhesive, the water vapor barrier property is remarkably improved. Thereby, the low humidity state of the EVOH resin layer 25 can be kept, and the gas barrier performance by EVOH can be kept good. Further, since no adhesive is interposed between the cyclic olefin resin layer 27, the polypropylene resin layer 28, and the cyclic olefin resin layer 29, elution of the adhesive component from the adhesive layer 26 into the chemical solution is suppressed. be able to.

  According to the present embodiment, a container having good gas barrier performance is obtained by providing a cyclic olefin in the inner layer and providing a cyclic olefin and a resin having good adhesiveness between the EVOH resin layer and the cyclic olefin layer. Is possible. Moreover, since the low humidity state of the EVOH layer can be maintained even if the cyclic olefin layer is thin, a container having excellent flexibility can be obtained. Thereby, the contractility is good, and even if the amount of the chemical solution in the bag is reduced, an internal pressure can be applied in the vicinity of the discharge port, and it is possible to suppress the discharge amount of the chemical solution from being attenuated. Furthermore, a cyclic olefin layer is provided in the inner layer for low drug adsorption, and elution into a chemical solution, which was a problem when using an adhesive, can be suppressed.

  As described above in detail, according to the present invention, the characteristics of the cyclic olefin are maintained, and the medical container that can meet the demands of the market in terms of mechanical strength, gas barrier properties, chemical resistance and dissolution resistance of adhesive components. Is provided not only to enable long-term use of the container, but also to extend the shelf life or shelf life without modification of the contents, especially in the pharmaceutical industry, food industry, cosmetics industry, etc. It is extremely large.

DESCRIPTION OF SYMBOLS 1 Medical container 2 Outer layer 3 Adhesive layer 4 Intermediate layer 5 Cyclic olefin resin layer 11 Discharge port part 12 Hanging part 13 Trunk part 20 Medical container 22 Polypropylene resin layer which added styrene elastomer 23 Cyclic olefin resin layer 24 Adhesive Layer 25 Ethylene-Vinyl Alcohol Copolymer (EVOH) Resin Layer 26 Adhesive Layer 27 Cyclic Olefin Resin Layer 28 Polypropylene Resin Layer Added with Styrene Elastomer 29 Cyclic Olefin Resin Layer

Claims (6)

A medical container having an inner layer made of a cyclic olefin-based resin and bonded to an adjacent layer using an adhesive;
It is provided adjacent to the inner layer without using an adhesive, and has an intermediate layer made of a resin different from the cyclic olefin resin and made of a resin having good adhesiveness with the cyclic olefin resin,
A medical container, wherein the intermediate layer and the outer layer are bonded using the adhesive.   The medical container according to claim 1, wherein the intermediate layer is a resin having lower rigidity than the cyclic olefin-based resin.   The medical container according to claim 1, wherein the outer layer is made of EVOH.   The medical container according to any one of claims 1 to 3, wherein the intermediate layer includes a plurality of resin layers.   The intermediate layer includes the cyclic olefin-based resin on the outer layer side, and a resin different from the cyclic olefin resin on the inner layer side, the resin having good adhesiveness with the cyclic olefin resin. 4. A medical container according to 4.   6. The resin according to claim 1, wherein the resin different from the cyclic olefin resin and having good adhesiveness with the cyclic olefin resin is a polypropylene resin containing a styrene elastomer. Medical containers.

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