JPS63110132A - Medical plastic vessel - Google Patents

Abstract

(57) [Abstract] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed Description of the Invention] fal Industrial Field of Use This invention relates to medical containers, which are used to store, use, etc. liquid drugs for infusion, injection, administration, etc. such as Ringer's solution, glucose solution, amino acid solution, etc. This relates to a plastic container for housing the

(b) Prior art Conventionally, medical containers used for the above purposes include:
Vials made of glass (vials), polyolefin resin (bottles), or polyvinyl chloride (PVC) containing plasticizer (bags) are used, but glass vials are prone to damage due to impact, large weight, and empty. There are problems such as complicated bottle processing and the infiltration of bacteria through the air needle.Polyolefin bottles are not transparent enough, so visual inspection is incomplete, they have low heat resistance, and they are softer than air needles because they allow bacteria to enter. PVC
Bafugu had drawbacks such as the risk of plasticizer leaching and poor barrier properties against water vapor and other elements, but all containers have problems due to the Japanese Pharmacopoeia and other regulations. At present, it is currently being used.

Currently, in order to eliminate the above-mentioned drawbacks of conventional containers, plastics for infusions using laminated films have been proposed in place of the above-mentioned PvC bags, and are currently being used in other countries. There are problems that need to be solved as will be described later.

le) Problems to be solved by the invention The purpose of using a laminate film as a container material is to provide an outer layer that takes into account dimensions, mechanical stability, protection of printing, impact resistance, water vapor and gas barrier properties, and heat sealability. , an inner layer that takes into account heat resistance, impact resistance, water vapor and gas barrier properties, hygiene against the contents of chemicals, etc., and an intermediate layer that specifically provides heat resistance, impact resistance, water vapor and gas barrier properties, etc., each having a role. The goal is to take advantage of the characteristics of each layer and combine them in a divided manner.

However, the material for plastic containers for infusions in Japan is limited by the Japanese Pharmacopoeia to a single layer of PvC with polyethylene, polypropylene, and dioctyl phthalate (DOP) as plasticizers. Even those that have been approved are not yet approved in Japan.

This is because there are problems, especially in terms of hygiene.

Generally speaking, the method of laminating plastic film is as follows:
Methods are broadly divided into methods using adhesives and methods without adhesives, but adhesives are usually used to laminate different types of plastic films.

The most common method of laminating using adhesives is the dry laminating method, in which the adhesive is dissolved in a solvent, and the solvent is evaporated before being applied to one film and then applied to the other film. It consists of the process of laminating the film.

Furthermore, there is a non-solvent method, which differs from the dry lamination method in that it involves applying the adhesive itself to the film and pasting it with another film.This method does not use a solvent, so it eliminates the negative effects of the residual F6 shoulder described later. However, the heat resistance and impact resistance are inferior to those made by the dry lamination method, such as laminates of polyamide resin and polyolefin resin, and plastic containers laminated with adhesives that do not use solvents are suitable for medical infusions with a content of 500mf or more. Not suitable for containers etc.

Next, the adhesive for dry lamination mentioned above is generally a urethane-based two-component reactive adhesive with isocyanate resin as the main ingredient and ether or ester resin as the curing agent, and acetic ester as the organic solvent. Ketones (mainly ethyl acetate) (mainly methyl ethyl ketone), toluene, and mixtures thereof are used.

(In addition, ethyl acetate, methyl ethyl ketone, and toluene are all deleterious substances outside the pharmaceutical layer.) The dry lamination method has almost no restrictions on the type of film that can be laminated, and has excellent heat resistance and impact resistance, which are necessary for infusion bags, etc. A laminated film is obtained, and over time, there are no other problems when used as containers for sugar drugs, protein amino acid preparations, organic acid preparations, electrolyte solutions, plasma substitute drugs, etc. that are normally filled in infusion bags etc. However, there is a major problem with residual solvents.

That is, for example, ethyl acetate (b, p, 76
．． 82°C), it is difficult to reduce the residual solvent to 2/M or less.
Assuming that 0g of drug solution is filled and all of this residual solvent is transferred to the drug solution, the amount will reach 80ppm, which is fatal for infusion drugs, where large amounts of the same drug are often instilled over a long period of time in the same container. It becomes a defect.

Furthermore, toluene (b, p) having a relatively high boiling point, for example, toluene (b, p).

110.8° C.), residual solvent was found to be 5 times more than that of ethyl acetate.

Furthermore, in this type of adhesive, residual or elution of unreacted main ingredients and curing agents also poses a problem.

As mentioned above, lamination methods that use adhesives are difficult to use considering the hygiene and strength aspects of medical infusion containers, and commercialization is unlikely in Japan, where strict regulations have been established. It is possible.

This invention eliminates the residue of solvent and unreacted organic matter (
Moreover, the aim was to provide a medical plastic container using a laminate with excellent heat resistance and impact resistance, and as a result of research, this was completed.

(d) Means and action for solving the problems In order to achieve the above-mentioned purpose, the medical plastic container according to the present invention has the following features:
No residual solvent or unreacted organic matter, heat resistant,
In order to create a laminate film with excellent impact resistance, etc., it is necessary to use polyamide resin, polyolefin resin, etc., which are bonded to the film used for the laminate base material of medical plastic containers for infusions, etc., without using so-called adhesives. It is necessary to use an adhesive resin that has excellent properties, heat resistance, and impact resistance, and can be laminated using normal lamination methods without causing any hygiene concerns. As the adhesive resin, it is appropriate to use an adhesive resin based on an olefin or ethylene-hynylacetate copolymer system and into which a carboxylic acid group has been introduced (for example, Atmer manufactured by Mitsui Petrochemical Industries, Ltd.).

That is, as shown in the cross-sectional view in Fig. 1, an adhesive resin layer (1) is interposed between the outer layer (2), which corresponds to the outer surface of the container and is in contact with the outside air, and the inner layer (3), which corresponds to the inner surface and is in contact with chemicals, etc. RFI (a, and b).

Alternatively, an intermediate N (4
), the outer layer (2), the inner layer (3) and the middle layer (4)
In between, the adhesive resin layer (1) is thermally bonded and laminated (C).

Note that, if necessary, it is possible to provide two or more intermediate layers (4), and furthermore, it is also possible to use other adhesives in combination with the outer layer portion that is not affected by residual solvents and the like.

In addition, coextrusion inflation and coextrusion blow molding are extremely effective in producing these laminate films for use in medical plastic containers.

It is possible to perform multilayer lamination in one step.

■Because it is a tube shape, if you keep the air blown into a clean state using a filter etc., there will be no infiltration of foreign substances or bacteria into the inside, so the surrounding environment equipment will be relatively relaxed, especially when extruding. The heating also serves as a sterilization process, allowing for complete sealing afterwards.

■Since it is finished in a tube shape, it simplifies the bag making process and saves on materials.

This is due to the following reasons.

(Q) Examples Example 1. A 25μ thick unstretched nylon (CN) and a 60μ thick unstretched polypropylene (CPP) were used as a 5μ resin layer of a thermoadhesive resin (Atomer QF 305 manufactured by Mitsui Petrochemical Industries, Ltd.) under the conditions described below using a multilayer coextrusion inflation method. A test piece was prepared by extrusion molding.

Example 2 Polyethylene terephthalate (PET) 25μ Unstretched polypropylene (CPP) 60μ was prepared using Atomer QF305 in Example 1. A test piece was prepared under the same conditions.

Example 3 Polyethylene terephthalate (PET) 25μ unstretched nylon (CN) 25μ Atomer Q
Example 1 using F305. A test piece was prepared under the same conditions.

Comparative Example (A) Said Example 1.2.3. The two films were adhesively laminated by dry lamination.

Comparative Example (B) Example 1.2.3. The two films were adhesively laminated by extrusion lamination.

Comparative Example (C) Example 1.2゜3. The two films were adhesively laminated by co-extrusion lamination.

Comparative Example (D) Example 1.2.3. Two films each were adhesively laminated by a hot press method (pressing temperature: 190° C.).

The test results of lamination strength for each of the above examples and comparative examples are as shown in the following table, and the examples of the present invention obtained extremely superior results in lamination strength compared to each conventional lamination method. Ta.

The measuring equipment and conditions were as follows.

■Shimadzu Autograph S-100 constant speed moving type tensile tester) Tensile speed used: 100 mm/min Peeling conditions: T type 180° peeling unit
The equipment and conditions used to prepare the above sample are as follows.

1. Laminating machine using multi-layer inflation lamination method using thermoadhesive resin ■K 40/40/40 R made by Plako Resin temperature used: CN 240℃, CPP 200℃thermal adhesive resin 2o0℃ Lamination speed 25m/lll1n2, extrusion lamination method using thermoadhesive resin Machine: Sumitomo Heavy Industries @Resin temperature used: 300°C Lamination speed: 110m/+m1n3, dry lamination adhesive Attocoat 300A and 300B, manufactured by Toyo Ink Manufacturing @: 300^: 300B: Ethyl acetate-15: 15
: Diluted and used at a ratio of 70% (weight ratio).

Laminating machine made by Okazaki Machinery Drying temperature used
60~80℃ Lamination speed 100m/m1ri4, extrusion lamination method (1 and 2. extrude cPP, 3.
(extrudes CN) Laminating machine Jujuki Kikai Kogyo ■
Made Resin temperature CPP (1,2>28
0”CCN(3) 320℃ Lamination speed CP P 120m/m1nCN
100a+/win 5, co-extrusion lamination method laminating machine manufactured by Hitachi Zosen Sangyo Co., Ltd. Used resin temperature
CN230"c, CPP200"c Lamination speed: 35 m/m1n 6. Heat press lamination method: A press of 20 CIll x 20 CIF was used in an in-house hydraulic press machine.

Press temperature 220℃ Press pressure 50+r/co! Press time: 1 sec if) Effects of the invention The medical plastic container according to the present invention uses films with excellent heat resistance, impact resistance, etc., and laminates them with a solvent-free adhesive resin, thereby eliminating residual solvent. , it is possible to avoid the adverse effects of residual unreacted adhesive pigments (and also to have extremely excellent laminate strength), and it is also possible to perform coextrusion inflation molding, coextrusion blow molding, etc. This is a novel invention that can contribute to improving hygiene, simplifying processes, saving materials, etc.

[Brief explanation of the drawing]

FIGS. 1(a), 1(b), and 1(c) are partial cross-sectional views of a laminate film constituting a medical plastic container according to the present invention. Figure 2 is a cross-sectional view of a container inflation tube made by coextrusion inflation molding.

Claims (2)

[Claims] (1) When laminating synthetic resin films, etc. that constitute two layers, an outer layer and an inner layer, or multiple layers, such as an outermost layer, an intermediate layer, and an innermost layer, a part or all of each adhesive layer is laminated using a solvent-free adhesive resin. A medical plastic container characterized by its laminated structure. (2) Medical use according to claim 1, characterized in that the lamination of synthetic resin films via a solvent-free adhesive resin and the molding of the container body are performed by coextrusion inflation molding or coextrusion blow molding. plastic container.