JPH05269201A - Medical container - Google Patents

Abstract

PURPOSE:To provide a medical container for medicines, blood, pharmaceutical solution or the like, which is excellent in gas resistance and vapor permeability, which is very safe in use and which can prevent environmental pollution during burning of used articles. CONSTITUTION:A medical container is made of a block copolymer of an aromatic group vinyl compound and isobutylene, having at least a gas-resistant and vapor-permeable layer.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a novel pharmaceutical / medical container having at least a gas resistant and water vapor permeable layer formed of a block copolymer composed of an aromatic vinyl compound and isobutylene.

[0002]

2. Description of the Related Art Conventionally, medicines for blood preservation, non-oral drug solutions, etc., formed of plasticized polyvinyl chloride resin softened by the addition of a plasticizer such as dioctyl phthalate
Medical containers are known. Although the container made of plasticized polyvinyl chloride resin is excellent in flexibility and flexibility, it cannot be sterilized by migration of plasticizer or ethylene oxide sterilization by plasticizer or γ-ray sterilization. There are drawbacks such as environmental pollution.

As a method for improving these drawbacks, an attempt to use a polymer alloy composed of hydrogenated butadiene-styrene block copolymer / polypropylene / ethylene / acrylic acid ester copolymer (Japanese Patent Laid-Open No. 2-1279), An attempt to use a laminate of a flexible layer composed of a styrene-butadiene block copolymer and a polyolefin such as polyethylene and a water vapor resistant layer composed of polyisobutylene and high density polyethylene (Japanese Patent Publication No. 63-5019).
No. 7) is proposed.

Although the above-mentioned drawbacks are solved to a large extent by these methods, the production process is complicated and the cost is increased because a plurality of polymers are mixed or a plurality of polymer layers are laminated. There is a problem and improvement is required.

[0005]

SUMMARY OF THE INVENTION It is an object of the present invention to provide a medical / pharmaceutical container which solves the above problems of the prior art and can be manufactured by a simple manufacturing process.

[0006]

According to the present invention,
There is provided a pharmaceutical / medical container having at least a gas resistant and water vapor resistant layer formed of a rubber material made of a block copolymer of an aromatic vinyl compound and isobutylene.

The block copolymer used in the present invention comprises at least one aromatic vinyl compound-based polymer block, preferably two aromatic vinyl compound-based polymer blocks, and at least one aromatic vinyl compound-based polymer block. It consists of a polymer block mainly composed of isobutylene. The structure of the block copolymer is not particularly limited, and includes (AB) _n , A- (B
_{-A) n, B- (A-} B) linear structure such as _n, [(A-B)
_n ] _{m + 1-} X, [(B-A) _n- B] _{m + 1-} X, [(A-
B) _n- A] _{m + 1-} X or the like, and may have a linear or branched structure, or a mixture thereof (in the above formula, m and n are integers of 1 or more, and X is The residue of a polyfunctional polymerization initiator is shown).

As the aromatic vinyl compound, styrene,
α-methylstyrene, β-methylstyrene, p-methylstyrene, t-butylstyrene, monochlorostyrene,
Examples include dichlorostyrene, methoxystyrene, indene and the like.

Further, other cationically polymerizable monomers may be copolymerized in the block copolymer within a range not impairing the performance of the article of the present invention. Examples of such a cationically polymerizable monomer include 1-butene, pentene, hexene, butadiene, isoprene and methyl vinyl ether.

The content ratio of the aromatic vinyl compound and isobutylene in the block copolymer is not particularly limited, and the optimum ratio is determined according to the kind of the article of the present invention and the required characteristics, but usually the aromatic The range of 10 to 50% by weight of the vinyl compound and the range of 50 to 90% by weight of isobutylene are preferable. When the content of the aromatic vinyl compound is less than 10% by weight, the strength is lowered, and when it exceeds 50% by weight, the workability and the water vapor permeation resistance are deteriorated. More preferably, the content ratio of the aromatic vinyl compound is 20 to 45% by weight.

In the present invention, the molecular weight of the block copolymer is not particularly limited, but normally, the number average molecular weight (measured by GPC, converted to standard polystyrene) is 30,000.
It is in the range of 0 to 500,000. Number average molecular weight is 3
If it is less than 10,000, the fluidity increases, and the bag of the present invention is easily deformed during high-pressure steam sterilization, which is not preferable.
On the other hand, if it exceeds 500,000, the viscosity becomes high, the processability is deteriorated, and it is difficult to form a sheet, which is not preferable. It is preferably in the range of 50,000 to 400,000.

In the present invention, the method for producing a block copolymer of an aromatic vinyl compound and isobutylene is not particularly limited. For example, a Lewis acid and an organic compound which forms a cationic polymerization active species in combination with Lewis acid (hereinafter In the presence of an initiator system consisting of
It can be produced by adding a third component such as amines and esters as necessary and polymerizing an aromatic vinyl compound and isobutylene in an inert solvent such as hexane or methylene chloride.

The initiator compound is an organic compound having a functional group such as an alkoxy group, an acyloxy group or a halogen, for example, bis (2-methoxy-2-propyl).
Examples thereof include benzene, bis (2-acetoxy-2-propyl) benzene and bis (2-chloro-2-propyl) benzene. Examples of Lewis acids include titanium tetrachloride, boron trichloride, aluminum chloride, etc., examples of amines include triethylamine, and examples of esters include ethyl acetate.

Among the block copolymers, the linear block copolymer uses an initiator compound having one functional group and a Lewis acid as an initiator system, and an aromatic vinyl compound until the reaction is substantially completed. After polymerization, isobutylene may be added to the polymerization system, and the aromatic vinyl compound may be polymerized again after the substantial polymerization reaction of isobutylene is completed. In addition, an initiator compound having two functional groups and a Lewis acid are used, isobutylene is polymerized until the reaction is substantially completed, and then an aromatic vinyl compound is added to the polymerization system to continue the polymerization reaction. It can be manufactured by a method.

In order to obtain a branched block copolymer, usually, isobutylene is polymerized using an initiator compound having three or more functional groups and a Lewis acid until the reaction is substantially completed, and then the polymerization system is used. It can be produced by a method in which an aromatic vinyl compound is added to continue the polymerization reaction.

A pharmaceutical / medical container having at least a water vapor permeation resistant layer of the present invention comprises a light stabilizer, an ultraviolet absorber, an antioxidant, if desired, depending on the type and the required characteristics of the block copolymer. Manufactured by adding agents, inorganic fillers / reinforcing agents, coloring agents, etc. As these additives, those conventionally used in the production of the article can be used and are not particularly limited. In addition, other thermoplastic polymers (for example, block copolymers of styrene and butadiene and hydrides thereof, block copolymers of ethylene and propylene, ethylene-acetic acid, etc.) are used as long as the gist of the present invention is not impaired. Vinyl copolymers, polystyrene, etc.) can be mixed. The block copolymer and these additional components are rolls,
The mixture is mixed using a mixer such as a kneader, an extruder, or a Banbury mixer to obtain a molding composition.

The container of the present invention is obtained by melt-extruding the above-mentioned molding composition into a mold having the shape of the intended container and blow-molding it or making it into a sheet using a calender or an extruder. After molding, cutting into a predetermined shape and stacking, the ends are
Manufactured by tossing.

In the pharmaceutical / medical container of the present invention, the one formed by only the layer using the block copolymer sufficiently satisfies the required performance, but if necessary, supplementation with other polymer is used. It may be formed by laminating with a conventional layer.

The container of the present invention is characterized by excellent transparency,
It has gas and water vapor permeation resistance, has sufficient flexibility without the use of plasticizers, is non-eluting and does not worry about the reaction between eluate and chemicals, etc. It is possible to boil in water, to sterilize ethylene oxide, to γ-ray, to incinerate waste, and to easily manufacture.

The container of the present invention can be used as a blood container of various shapes, a container for infusion of various medicines, nutrients and the like, a sterilization bag, etc., but is not limited to these examples.

[0021]

The present invention will be described in detail below with reference to examples. Table 1 shows the properties of the block copolymers used in the following examples.

[0022]

[Table 1]

Example Using each block copolymer shown in Table 1 and a commercially available block copolymer (KRATON G1652 manufactured by Shell Chemical Co., Ltd. and TUFTEC H1041 manufactured by Asahi Kasei Kogyo Co., Ltd.), a thickness of 0.3 mm was obtained by heating and pressurizing. A 10 cm x 15 cm bag-making sheet was produced. Water vapor permeability and air permeability were measured using these sheets, a commercially available polyethylene bag, and a polyvinylidene chloride film (Saran Wrap manufactured by Asahi Kasei Corporation).

Water vapor permeability is determined by placing a certain amount of distilled water in an aluminum cup, sealing the open part of the cup with each of the above sheets or films, and leaving it in an atmosphere of 40 ° C. for 24 hours. The weight was measured for each time. The results are shown in Table 2, and the block copolymer sheet used in the present invention exhibited very excellent resistance to water vapor permeation.

The air permeability is 0.
A sheet of 1 to 0.2 mm was prepared and measured at 21 ° C. (using a gas permeation device K-315-N manufactured by Rika Seiki Co., Ltd.). The results are shown in Table 3, and the block copolymer sheet used in the present invention showed very excellent resistance to air permeation.

[0026]

[Table 2]

[0027]

[Table 3]

Sheets using the block copolymers shown in Table 1 were eluted by the Japanese Pharmacopoeia test method for plastic containers for infusion (Test method a) and elution with distilled water for injection based on the vinyl chloride resin blood set announced by the Ministry of Health. Material test (Test method b)
I went. The results are shown in Table 4, which shows sufficient safety and hygiene.

[0029]

[Table 4]

[0030]

The pharmaceutical / medical container of the present invention is formed of a block copolymer of an unvulcanized aromatic vinyl compound and isobutylene to which no plasticizer is added. It is made from added vinyl chloride resin and is very safe compared to the conventional articles. Further, not only the gas permeation resistance and water vapor resistance are remarkably improved as compared with the conventional product, but also other physical characteristics required for the container are comparable to those of the conventional product. Furthermore, even if the used container is incinerated, there is no fear of polluting the environment. Therefore, the medical / pharmaceutical container of the present invention can be used as a container for drugs, blood storage, drug solutions, sterilization, and the like.

[Table 5]

Claims (5)

[Claims] 1. A pharmaceutical / medical container having at least a gas-proof and water vapor-permeable layer formed of a rubber material made of a block copolymer of an aromatic vinyl compound and isobutylene. 2. The pharmaceutical / medical container according to claim 1, wherein the container is for a drug. 3. The pharmaceutical / medical container according to claim 1, wherein the container is for storing blood. 4. The pharmaceutical / medical container according to claim 1, wherein the container is for a drug solution. 5. The container is for a sterilization bag.
The described pharmaceutical / medical container.