JP2005204789A - Injection preparation with high usability - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To prevent liquid leakage when sucking liquid medication from a container storing injection solution to a syringe and prevent the leakage of the injection solution left in the container after the injection when the container falls down. <P>SOLUTION: A bottomed cylindrical plastic container welded and sealed with a film which enables to puncture the opening part of the plastic container with a needle is used, so that an injection needle can be directly inserted therein without peeling off the film. The film is thus existed at the opening part even after the injection to prevent the leakage of the injection solution left in the container after the injection, when the container falls down. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

  The present invention relates to an injection preparation in which an injection solution is contained in a bottomed cylindrical plastic container sealed by welding an opening with a film that can be punctured with a needle. In particular, the present invention relates to an injection preparation in which the injection solution is a narcotic, and an injection preparation in which the injection solution is a morphine hydrochloride solution. Moreover, it is related with the method of managing the morphine hydrochloride solution after the injection using this container.

As an injection preparation, an injection preparation in which an injection solution is contained in a glass ampule is generally known. However, there were problems such as accidents of hand and finger injuries when opening glass ampoules and leakage of chemicals due to overturning of ampoules after opening ampoules.
On the other hand, a prefilled syringe or the like is used as an injection preparation without the above-mentioned problems. For example, Patent Document 1 describes a prefilled syringe made of a synthetic resin such as polypropylene and integrated with a syringe. However, since the prefilled syringe is bulky, there is a problem in transportation.
Apart from the above, several plastic containers are known as containers for injections. Patent Document 2 describes a sealed soft plastic container that contains a pharmaceutical solution and a container made of a film or sheet that encloses the container. Patent Document 3 describes a sealed plastic container containing a pharmaceutical solution and a container containing a pharmaceutical solution comprising a sealed film or sheet containing the plastic container. However, none of the documents describes a bottomed cylindrical plastic container sealed by welding an opening with a film that can be punctured with a needle.

Currently, narcotics are used to obtain analgesic and sedative effects during severe pain associated with cancer. One of the dosage forms is an injection preparation. As an injection preparation of morphine hydrochloride, a morphine hydrochloride preparation in which a morphine hydrochloride solution is contained in a glass ampoule or a morphine hydrochloride preparation in which a morphine hydrochloride solution is previously contained in a plastic syringe are commercially available.
JP 2002-172166 A Japanese Patent Laid-Open No. 7-100185 Japanese Patent Application Laid-Open No. 5-49647

In a conventional injectable preparation using a glass ampoule as a container, it is necessary to prevent leakage of a chemical solution remaining in the container after opening. In particular, in the case of narcotics, it is necessary to strictly manage the drugs under the Drug Enforcement Law, and prevention of chemical leakage is a major issue.
For example, as a morphine hydrochloride injection preparation, a 10 mg injection containing 1 ml of glass ampule, a 50 mg injection containing 200 ml of glass ampule, and a 200 mg injection are available.
When 80 mg is prescribed, 8 mL corresponding to 80 mg out of two 50 mg injections may be used, and 2 ml of residual liquid corresponding to 20 mg may be generated.
In the above case, the usage amount is managed by describing that the remaining amount is 20 mg or 2 ml on the prescription and confirming that the amount of liquid remaining on the glass ampoule matches the remaining amount described on the prescription. ing.
In the case of a glass ampoule, a relatively large hole is opened after opening, so that when the ampoule falls down, the contained chemical solution may leak. That is, it is very important in terms of narcotic management to prevent leakage of morphine hydrochloride remaining in the container after injection when the container falls.
In the medical field, from the viewpoint of preventing leakage of residual liquid when the glass ampoule falls down, the opened glass ampoule opening is closed with cellophane tape or placed in the syringe until the confirmation work by the drug administrator. It is currently being sucked and stored.
In the case of a prefilled syringe, although the above-mentioned problems can be solved, the container is bulky and has problems in terms of storage and transportation.

In view of the above circumstances, as a result of the study by the present inventors, the injection solution was fallen into the container by storing the injection solution in a cylindrical plastic container with a bottom sealed by welding with a film that can be punctured with a needle. The inventors have found that it is possible to prevent leakage of the injection solution at the time, and have completed the following invention.
(1) An injection preparation in which an injection solution is contained in a bottomed cylindrical plastic container sealed by welding an opening with a film that can be punctured with a needle.
(2) The injection preparation according to (1), wherein the container is made of polypropylene.
(3) The injectable preparation according to (1), wherein the horizontal cross section of the container is circular.
(4) The injectable preparation according to (3), wherein the horizontal cross section of the container has an inner diameter of 0.5 to 2 cm and a height of 3 to 7 cm.
(5) The injection preparation according to (1), wherein the film material is a transparent resin film.
(6) The injection preparation according to (5), wherein the film is a strongly weldable film that cannot be peeled off.
(7) The injection preparation according to (6), wherein the film is further covered with a peelable, weakly welded protective film.
(8) The injection preparation according to (1), wherein the container is calibrated.
(9) The injection preparation according to any one of (1) to (8), wherein the injection solution is a narcotic.
(10) The injection preparation according to (9), wherein the injection solution is a morphine hydrochloride solution.
(11) The amount of morphine hydrochloride solution after injection remaining in the bottomed cylindrical plastic container sealed by welding the opening with a film that can be punctured with a needle, and the remaining amount of morphine hydrochloride described in the prescription Is a management method of morphine hydrochloride solution to confirm that the two match.

  By welding the opening of the plastic container with a film that can be punctured with a needle, it has become possible to puncture the injection needle directly without removing the film. Thereby, it is possible to prevent liquid spilling during the suction of the drug solution from the ampoule opening to the syringe and leakage of the injection solution remaining in the container after injection when the container falls.

An injection preparation containing an injection solution in a bottomed cylindrical plastic container sealed by welding the opening of the present invention with a needle-piercable film is directly inserted into the injection needle without removing the film. It is possible to prevent the leakage due to liquid spilling during the suction of the drug solution from the ampoule opening to the syringe and the fall of the drug solution remaining in the container after the injection, which is a problem of the conventional glass ampoule preparation. The present invention is preferable in terms of narcotic management when the injection solution is a narcotic, particularly morphine hydrochloride.
In addition, unlike conventional glass ampules, ampule cutting is not required, so that preparation work can be simplified and accidents of hand and finger cuts can be prevented. Since the container is plastic, it does not break. From the situation where there are many glass ampoules in the market, it can be differentiated from other items, the distinction from other items can be improved, and erroneous administration can be prevented. There is also an advantage of downsizing the individual packaging box.
In addition, the above-described liquid spillage prevention can be similarly applied to a conventional vial sealed by tightening a rubber stopper and an aluminum cap. However, in the case of a vial, since the inside of the container has a negative pressure, it is difficult to suck a chemical solution. In addition, when the chemical solution in the container is discarded or the container itself is separated and discarded, it is necessary to remove the aluminum cap. The injection of the present invention can also solve these problems.
Further, when the injection solution is morphine hydrochloride solution, it is preferable from the viewpoint of drug management (quantity, residual solution, safe storage), and the injection preparation containing the morphine hydrochloride solution of the present invention is very useful.

The container used in the present invention is a bottomed cylindrical plastic container, and the material thereof is not particularly limited, but polyethylene, polypropylene, polystyrene, polycarbonate, polymethylpentene, polymethacrylate, ethylene-vinyl acetate copolymer, Polyvinyl chloride, polyvinylidene chloride, polyethylene terephthalate, polyethylene naphthalate, ethylene vinyl alcohol copolymer, addition polymer of cyclic olefin and α-olefin, and ring-opening polymer of cyclic olefin, particularly polypropylene are preferred.
The shape of the plastic container is not particularly limited as long as it has a bottomed cylindrical shape, but a plastic container having a circular horizontal cross section or a polygonal shape (for example, a quadrangle) can be used. From the viewpoint of preventing rolling during storage and storage, a rectangular shape is preferable.
The plastic container used in the present invention is characterized in that the opening is sealed by welding with a film that can be punctured with a needle. Any film can be used as long as it can completely close the opening of the container so that the contained morphine hydrochloride solution does not leak and can be punctured with an injection needle without removing the film. As the film, an aluminum laminate film, a transparent resin film, or the like can be used. In particular, a transparent resin film is preferable.
As the film, a weakly weldable film that can be peeled or a strongly weldable film that cannot be peeled can be used.
In the case of using a weakly weldable film that can be peeled off, when the amount of the remaining liquid after injection is confirmed, the amount of the liquid can be measured by peeling the chemical solution into another container after the film is peeled off. In addition, the chemical solution can be easily discarded.
When a strongly weldable film that cannot be peeled is used, it is possible to reliably prevent leakage of the chemical solution, which is preferable for drug management. When the chemical solution is discarded, the film is broken and the chemical solution is discarded.

Even if the shape of the horizontal cross section of the plastic container is circular, it is possible to prevent rolling at the time of falling by using a film provided with a projection.
Moreover, in order to prevent a foreign material etc. adhering to the surface of a film, you may cover the outer side of this film with the weakly weldable protective film which can be peeled further.
Moreover, in order to measure easily the amount of chemical | medical solutions which remained in the container after injection, what gave the scale to the container is preferable.
Containers of various sizes can be used depending on the amount of chemical solution to be accommodated. For example, the thing which can accommodate 1 ml of chemical | medical solutions, the thing which can accommodate chemical | medical solutions, such as 5 ml and 10 ml, etc. are mentioned. For example, when the horizontal cross-sectional shape of the container is circular, a container having an inner diameter of 0.5 to 2 cm and a height of 3 to 7 cm can be used. When the horizontal cross section of the container is a quadrangle, one having a horizontal cross section of 0.5 to 2 cm and a height of 3 to 7 cm can be used.

  The injection solution is not particularly limited. Any injection solution can be used as long as it is an injection solution. From the present situation where many glass ampoules are used as injection preparations, the present invention is very significant from the viewpoint of improving the distinction from other injections. In view of the characteristics of the injection preparation of the present invention, the narcotic injection solution is particularly preferable as the injection solution. Currently, the only commercially available narcotic injection solution is morphine hydrochloride injection solution, but even narcotic injection solutions other than morphine hydrochloride injection solution can be used as the injection preparation of the present invention.

  A particularly preferred embodiment of the plastic container used in the present invention is a bottomed cylindrical plastic container sealed with a strongly weldable film that cannot be peeled, the opening being covered with a peelable weakly welded protective film. . After peeling off the protective film, the injection needle is punctured directly into the sealing film to suck the drug solution.

The present invention will be described more specifically with reference to the following examples. However, this is merely an example and does not limit the present invention.
After filling a plastic container made by injection molding with a chemical solution, heat sealing is performed with an aluminum laminate film or a transparent resin film at 170 to 210 ° C. for 0.5 to 3 seconds at a pressure of 1 to 3 kgf / cm ^2. Thus, an injection contained in a bottomed cylindrical plastic container sealed by welding the opening shown in FIG. 1 with a film that can be punctured with a needle was obtained.

The ampule injection after opening and the chemical leakage in the injection of the present invention after the needle was inserted into the film were evaluated.
(Method) After 5 g of ampule for 5 mL was filled with water and sealed, the specimen prepared by opening and the container of the present invention shown in FIG. 1 was filled with 5 g of water and a sealing film was applied. Sample prepared by piercing an 18G needle to make a hole, condition 1: falling from a stationary state, condition 2: dropping from a height of 10 cm onto a desk, condition 3: dropping from a height of 80 cm onto the floor, and the sample liquid The amount of spillage was measured by weight loss (Tables 1-3).
As a result, under any condition, the injection of the present invention has a lower risk of liquid spillage than the conventional glass ampoule, and it is considered that almost no chemical leaks when the container falls on a desk.

It is a schematic diagram of this invention container.

Claims (11)

An injection preparation in which an injection solution is contained in a bottomed cylindrical plastic container sealed by welding an opening with a film that can be punctured with a needle. The injectable preparation according to claim 1, wherein the container is made of polypropylene. The injectable preparation according to claim 1, wherein the horizontal cross section of the container has a circular shape. The injectable preparation according to claim 3, wherein the horizontal cross section of the container has an inner diameter of 0.5 to 2 cm and a height of 3 to 7 cm. The injectable preparation according to claim 1, wherein the film material is a transparent resin film. The injection preparation according to claim 5, wherein the film is a strongly weldable film that cannot be peeled off. The injectable preparation according to claim 6, wherein the film is further covered with a peelable weakly welded protective film. The injectable preparation according to claim 1, wherein the container is graduated. The injection preparation according to any one of claims 1 to 8, wherein the injection solution is a narcotic. The injection preparation according to claim 9, wherein the injection solution is a morphine hydrochloride solution. The amount of morphine hydrochloride solution after injection remaining in the bottomed cylindrical plastic container sealed by welding the opening with a film that can be punctured with a needle matches the remaining amount of morphine hydrochloride described in the prescription. How to manage morphine hydrochloride solution to confirm that.

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