JPH10323381A - Medical container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical container with all kinds of quality performance which are needed as a medical purpose such as transparency, shock resistance, flexibility, gas barrier, contamination-proof, strength under low temperature, and heat resistance. SOLUTION: In this medical container made of a multilayer film, the multilayer film includes an intermediate layer 1 formed of a mixed resin made of ethylene-vinyl alcohol copolymer and styrene resin, an inside adjacent layer 2 is formed so as to adjoin directly to the inside of the intermediate layer 1, the inside adjacent layer 2 is made of a resin with the main component of denatured polyolefin, a first mixed resin with the main components of denatured polyplefine and styrene resin, and a second mixed resin with the main components of polypropylene resin and styrene resin.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical container, and more particularly, to a medical container which is used for storing a medicine which is easily deteriorated with time due to oxidation, moisture absorption and the like.

[0002]

2. Description of the Related Art Conventionally, medicines which are difficult to maintain stability due to oxidative decomposition or hydrolysis are often filled and stored in glass containers. There are problems such as contamination due to elution and cut foreign matter generated when using ampules.Recently, plastic containers typified by polyethylene and polypropylene have been changed in consideration of the benefits during transportation and use. ing.

However, compared to glass, the above-mentioned plastic container has a large amount of gas permeation such as water vapor, oxygen and carbon dioxide gas, and is not suitable for pharmaceuticals whose stability is difficult to maintain due to oxidative decomposition or hydrolysis. There was a problem.

[0004] Recently, as one of measures to solve the quality performance problem, a plastic container is externally wrapped using a gas barrier film, and if necessary, a deoxidizer is provided between the container and the outer wrapping. It has been proposed to contain a desiccant or the like.

Conventionally, as gas barrier films for medical use, generally, films using silica-deposited polyethylene terephthalate, films deposited on alumina, aluminum laminated films, films using polyvinyl alcohol, films using ethylene / vinyl alcohol copolymer, films using polyvinylidene chloride, etc. Has been proposed,
Since these gas barrier films are generally rigid, pinholes are easily generated due to vibration during transportation and the like, and the holding stability of the contents is not sufficient. Further, since the gas barrier film is firm and bulky, it has been pointed out that there is a problem of dust when the gas barrier film is disposed after use.

On the other hand, it is conceivable to construct a medical container directly from the gas barrier film, but it is difficult to put it into practical use because of the following problems (1) and (2).

(1) If a high-pressure steam sterilization treatment necessary for storing a sterile preparation is performed, delamination occurs and the performance as a container cannot be maintained.

(2) Since the film itself is hard, strength
In particular, problems arise in impact resistance and flexibility. However, among the above-mentioned gas barrier films, an aluminum laminated film can solve the above problems (1) and (2), but in addition to the problem that the film is opaque and the contents cannot be seen from the outside, There is a problem that the adhesive component is transferred to the contents side through the plastic film and contaminates the contents, so that it is difficult to put it to practical use like the gas barrier film.

[0009]

DISCLOSURE OF THE INVENTION The present invention eliminates all of the above-mentioned conventional problems, and has medical barrier properties such as transparency, flexibility, impact resistance, low-temperature strength, heat resistance, and stain resistance as well as gas barrier properties. The purpose of the present invention is to provide a medical container having all the desired quality performances.

[0010]

According to the present invention, there is provided a medical container comprising a multilayer film, wherein the multilayer film includes an intermediate layer composed of a mixed resin of an ethylene / vinyl alcohol copolymer and a styrene resin. , An inner adjacent layer is formed so as to directly contact the inner surface side of the intermediate layer,
Be composed of a resin mainly composed of modified polyolefin, a first mixed resin mainly composed of modified polyolefin and styrene resin, or a second mixed resin mainly composed of polypropylene resin and styrene resin. The present invention relates to a medical container characterized by the above-mentioned.

In the present invention, the mixed resin constituting the intermediate layer preferably contains at least 50% by weight of an ethylene / vinyl alcohol copolymer and at least 5% by weight of a styrene resin.

Further, it is preferable that the first mixed resin constituting the inner adjacent layer contains at least 10% by weight of the modified polyolefin and at least 5% by weight of the styrene resin.

The second mixed resin forming the inner adjacent layer preferably contains at least 10% by weight of a polypropylene resin and at least 5% by weight of a styrene resin. As a modified polyolefin in an amount not exceeding 20% by weight.

An outer adjacent layer can be formed on the outer surface side of the intermediate layer. The outer adjacent layer is, similarly to the inner adjacent layer, a resin mainly composed of a modified polyolefin, a first mixed resin mainly composed of a modified polyolefin and a styrene resin or a polypropylene resin and a styrene resin as main components. Second
It may be composed of a mixed resin, and may be composed of nylon.

On the inner surface side of the inner adjacent layer, an innermost layer as a heat seal layer made of a mixed resin containing a polypropylene resin and a styrene resin as main components can be formed. The innermost layer is a third component in addition to the above two components.
A thermoplastic resin other than the component may be contained.

The outermost layer as a protective layer may be formed directly on the outside of the intermediate layer or via an outer adjacent layer. When the outermost layer is formed directly on the outside of the intermediate layer, the outermost layer can be made of, for example, a resin containing polyolefin as a main component, and can be bonded to the intermediate layer via an adhesive or an adhesive layer. it can.

On the other hand, when the outermost layer is formed outside the intermediate layer with an outer adjacent layer interposed therebetween, the outermost layer contains, for example, a polypropylene-based resin and a styrene-based resin as main components, and other thermoplastic resins as necessary. It can be composed of a mixed resin to which a resin is added. Since such a mixed resin has adhesiveness to the modified polyolefin, the first and second mixed resins, or nylon constituting the outer adjacent layer, it can be integrally molded by applying extrusion molding means to the outer adjacent layer.

[0018]

DESCRIPTION OF THE PREFERRED EMBODIMENTS One embodiment of the present invention will be described below with reference to the accompanying drawings.

FIG. 1 shows a medical container A of the present invention, and FIGS.
4 is a multilayer film A constituting the medical container A of the present invention.
1 illustrates various embodiments of the present invention.

The multilayer film A1 has an intermediate layer 1 made of a mixed resin of an ethylene / vinyl alcohol copolymer (hereinafter referred to as EVOH) and a styrene resin.

In the above mixed resin, EVOH is a resin having excellent gas barrier properties, and has a function of imparting gas barrier properties to the intermediate layer 1. EVOH must account for at least 50% by weight of the total weight, and is usually appropriately selected from the range of 50 to 95% by weight.

On the other hand, a styrene-based resin, particularly an elastomer thereof, is a resin having excellent heat resistance and low-temperature elasticity, and has a function of imparting heat resistance and low-temperature strength to the layer 1.
The styrene-based resin must account for at least 5% by weight of the total weight, and is usually appropriately selected from the range of 5 to 50% by weight.

The intermediate layer 1 composed of such a mixed resin is excellent in gas barrier properties, heat resistance and low-temperature strength. Also, since it contains a styrene resin, the hardness tends to be less than that of EVOH alone, and vibration and the like are reduced. Pinholes are less likely to occur even when received. Further, both the EVOH and the styrene-based resin are transparent, so that transparency necessary for a medical container can be secured.

An inner adjacent layer 2 is formed on the intermediate layer 1 so as to be in direct contact with the intermediate layer 1. The inner adjacent layer 2 is mainly composed of a modified polyolefin-based resin or a modified polyolefin and a styrene-based resin. The first mixed resin or the second mixed resin mainly composed of a polypropylene resin and a styrene resin.

Among the resins constituting the inner adjacent layer 2, the modified polyolefin or polypropylene resin has excellent flexibility and impact resistance, and functions to impart flexibility and impact resistance to the inner adjacent layer 2. . When the inner adjacent layer is composed of the first or second mixed resin, it is necessary that the modified polyolefin or polypropylene resin accounts for at least 10% by weight of the total weight, and usually 10 to 95% by weight. %
Is appropriately selected from within the range.

When the inner adjacent layer 2 is made of the first mixed resin or the second mixed resin, as described above, the styrene resin which is one component of the mixed resin has heat resistance and elasticity at low temperature as described above. Therefore, heat resistance and low-temperature strength can be imparted to the inner adjacent layer 2. The styrene-based resin must account for at least 5% by weight of the total weight, and is usually appropriately selected from the range of 5 to 70% by weight. In order to improve the adhesiveness between the first and second mixed resins, the modified polyolefin may have at least 10
% By weight.

The inner adjacent layer 2 composed of the modified polyolefin alone, the first mixed resin or the second mixed resin is soft, has moderate elasticity, has a slight cushioning property, and protects the intermediate layer 1 from impact. It works and is transparent. When the inner adjacent layer 2 contains a styrene-based resin, improved impact resistance, low-temperature strength and heat resistance can be obtained.

When a modified polyolefin is used for the inner adjacent layer 2, the hydroxyl group (-) found in EVOH in its molecule is used.
OH) to have a polar functional group such as
The adhesion between the EVOH of the mid layer 1 and the modified polyolefin is improved.

When a styrene resin is used for the inner adjacent layer 2, although the interlayer adhesion between the EVOH of the intermediate layer 1 and the polypropylene resin of the inner adjacent layer 2 is weak, it is a component common to both layers. Presence of styrenic resin, EV
Since the adhesiveness between OH and the styrene-based resin is good, and the polypropylene and the styrene-based resin are heat-resistant, an adhesive strength that can withstand high-pressure steam sterilization (for example, 121 ° C., 20 minutes) can be obtained.

As shown in FIG. 2, the intermediate layer 1 can be provided with an outer adjacent layer 2 'outside the inner adjacent layer 2 in addition to the inner adjacent layer 2. In this case, the intermediate layer 1 is protected from the inner and outer sides by the inner and outer adjacent layers 2, 2 '. The inner adjacent layer 2 also serves as a heat seal layer.

As in the case of the inner adjacent layer 2, the outer adjacent layer 2 'is made of a resin mainly composed of a modified polyolefin, a first mixed resin mainly composed of a modified polyolefin and a styrene resin,
Alternatively, it can be composed of a second mixed resin mainly composed of a polypropylene resin and a styrene resin. Also,
Since the EVOH constituting the intermediate layer 1 functions to prevent harmful components generated by hydrolysis or the like from migrating to the inner layer side, the outer adjacent layer 2 'has excellent flexibility, impact resistance and transparency. Nylon can be applied.

As shown in FIG. 3, an innermost layer 3 as a heat seal layer is formed on the inner side of the inner adjacent layer 2 and an outermost layer 4 as a protective layer is formed on the outer side of the outer adjacent layer 2 ', for example, by co-extrusion. A unit can be formed integrally by applying means.

The innermost layer 3 and the outermost layer 4 can be composed of a mixed resin of a polypropylene-based resin and a styrene-based resin. In addition to these two components, as a third component, a thermoplastic resin other than these, for example, polyethylene, polybutene , Poly-4-methylpentene, cyclic hydrocarbon resin, ethylene-vinyl acetate copolymer, ethylene-ethyl acrylate copolymer, ethylene-acrylate copolymer ethylene-methacrylic acid copolymer, modified polyolefin, etc. May be. The third component is used in the innermost layer 3 in order to obtain blocking resistance and easy peel sealability.
The outermost layer 4 is useful for obtaining blocking resistance. The mixing ratio of each component of the mixed resin is 25 to 90% by weight of a polypropylene resin and 5 to 7% of a styrene resin.
0% by weight and 5 to 50% by weight of other thermoplastic resins are suitable.

FIG. 4 shows a case where only the inner adjacent layer 2 is provided on the intermediate layer 1 and the outer adjacent layer 2 'is omitted. In this case, the inner surface of the inner adjacent layer 2 is provided with the type shown in FIG. Similarly, the innermost layer 3 as a heat seal layer can be formed.

On the outer surface side of the intermediate layer 1, an outermost layer 4 mainly composed of a polyolefin resin such as polyethylene or polypropylene can be formed as a protective layer. In this case, the polyolefin and the EVO of the intermediate layer 1 are used.
Since H has poor adhesion suitability, an adhesive (for example, a modified polyolefin) or an adhesive layer 5 (for example, nylon) is applied between the layers. In the latter case, the adhesive layer 5 has a function of reinforcing the intermediate layer 1. I do.

In the present invention, the styrene resin is not particularly limited, such as a homopolymer or a copolymer, but the following elastomers are preferred.

Styrene-based elastomer: polystyrene-
Vinyl polyisoprene, polystyrene-hydrogenated vinyl polyisoprene, polystyrene-vinyl polyisoprene-polystyrene, polystyrene-hydrogenated vinyl polyisoprene-polystyrene, polystyrene-ethylene butene, polystyrene-ethylene butene-polystyrene, polystyrene-ethylene propylene, polystyrene-ethylene Propylene-polystyrene, polystyrene-propylene butene, polystyrene-propylene butene-polystyrene, hydrogenated polystyrene-butadiene, hydrogenated polystyrene-butadiene-hydrogenated polystyrene, polystyrene-ethylenebutylene, polystyrene-ethylenebutylene-polystyrene, polystyrene-ethylenebutylene-polyethylene , Polystyrene-ethylenebutylene-polypropylene , Polystyrene-ethylene propylene-polyethylene, polystyrene-ethylene propylene-polypropylene, polystyrene-ethylene butene-polyethylene, polystyrene-ethylene butene-polypropylene, polystyrene-propylene butene-polyethylene, polystyrene-propylene butene-polypropylene The polyolefin refers to, for example, one obtained by reacting a polyolefin with an α, β-unsaturated carboxylic acid or an acid anhydride thereof. Specific examples thereof include maleic anhydride-modified polyethylene,
Examples thereof include maleic anhydride-modified polypropylene, ethylene / ethyl acrylate / maleic anhydride copolymer, and ethylene / vinyl acetate / maleic anhydride copolymer.

Further, the polypropylene resin may be any of a homopolymer (including amorphous and low-crystalline) and a copolymer (for example, a random polymer or a block polymer).

The multilayer film constituting the medical container of the present invention has an intermediate layer containing EVOH as a main component, and thus has excellent gas barrier properties unique to EVOH.

Further, since the intermediate layer 1 contains a styrene resin, the hardness of the EVOH tends to be reduced by the styrene resin and the inner adjacent layer 2 functions to reduce the impact. Regardless of the main component, pinholes and cracks do not occur even when subjected to an impact, and gas barrier properties can be stably maintained for a long time. Such performance can be further improved by providing the outer adjacent layer in addition to the inner adjacent layer.

Further, the intermediate layer 1 has improved flexibility, low-temperature strength and heat resistance due to the styrene resin contained therein, and the intermediate layer 1 and the inner adjacent layer 2 contain a styrene resin as a common component. Since the inner adjacent layer 2 contains the modified polyolefin having good adhesiveness to the EVOH of the intermediate layer 1, the risk of delamination occurring during high-pressure steam sterilization treatment due to high interlayer adhesive strength is eliminated.

Further, the inner adjacent layer 2 is directly provided inside the intermediate layer 1.
It is not necessary to provide an adhesive layer which causes contamination inside the intermediate layer 1 and the intermediate layer 1 prevents the transfer of contaminants from the outside to the inside due to its excellent barrier property. As a result, the contents are not contaminated by contaminants, and antifouling properties can be obtained.

Further, not only the EVOH, styrene resin and modified polyolefin constituting the intermediate layer 1 and the inner adjacent layer 2 but also the innermost layer 3, the outer adjacent layer 2 'and the outermost layer 4 are provided. Each of these layers is transparent,
The transparency required for a medical container is obtained. Examples of the present invention are described below, and the results of comparative experiments with the control examples are shown below.

[0044]

Example 1 Inner adjacent layer 60 μm: polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density: 0.910 g /
cm ³ , MI = 4) and a styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940)
g / cm ³ , MI = 0.7), 5: 5 by weight, 30 μm in the middle layer: ethylene / vinyl alcohol (EVOH) (trade name: EVAL, Kuraray Co., Ltd.)
And a styrene elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ³ , MI = 0.7) and a weight ratio of 7 : 3, outer adjacent layer 120 μm: polypropylene (trade name: Hypol, Grand Polymer Co., Ltd.)
Ltd., ^{Density: 0.910g / cm 3, MI =} 4) and styrene elastomer (trade name: HYBRAR, manufactured by Kuraray Co., Ltd., ^{density: 0.940g / cm 3, MI =} 0.7)
A resin having a width of 480 mm and a thickness of 21 mixed by a T-die method (temperature: 160 to 230 ° C.)
It was a 0 μm film. This film was cut to a length of about 1000 mm in the take-up direction. This film is folded in half with a crease perpendicular to the film take-off direction so as to make a bag having a length of 250 mm, and the seal width is 10 mm.
The upper and lower molds are heated at a temperature of 180 ° C to 195 ° C.
Heat sealing was performed at three places including the part folded at In this manner, a bag (bag) having a lateral dimension of 200 mm and a vertical direction of 250 mm, which was welded in three directions, was produced. Then, a port made of polypropylene having a density of 0.910 g / cm ³ was heat-welded to the opening. And 1 from the port
A polypropylene cap (density: 0.910 g / cm ³ ) filled with a 0 W / V% amino acid solution (amipalene solution) and fitted with a rubber stopper that has passed the Japanese Pharmacopoeia (13th revision)
Was thermally welded. This bag was left at room temperature for 24 hours after high-pressure steam sterilization at 115 ° C. for 40 minutes, and subjected to the following experiment.
The eligibility of the manufactured bags was determined.

[0045]

Example 2 The following film was formed on a five-layer five-layer water-cooled blown film molding machine. The resin composition is the outermost layer 60 μm: linear low-density polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.94)
0 g / cm ³ , MI = 2), adhesive layer 10 μm: modified polyolefin (trade name: ADMER, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g / cm ³ , MI = 2),
Intermediate layer 30 μm: EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio 38%) and styrene-based elastomer (trade name: Hibler, Kuraray Co., Ltd.)
(Density: 0.940 g / cm ³ , MI = 0.7)
7: 3 weight ratio, inner layer 60 μm: polypropylene (trade name: Hypol, Grand Polymer Co., Ltd.)
Ltd., ^{Density: 0.910g / cm 3, MI =} 6) and styrene-based elastomer (trade name: HYBRAR, Kuraray Co., Ltd., ^{density: 0.940g / cm 3, MI =} 0.
7) at a weight ratio of 5: 5, innermost layer 50 μm: polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd.)
Density: 0.910 g / cm ³ , MI = 8) and linear low density polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g / cm ³ , MI =
2) and a styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ³ , M
I = 0.7) in a weight ratio of 6: 3: 1.

The temperature setting of the extruder is 140 ° C. to 215
C., a mold temperature of 160 to 230 ° C., and a film take-off speed of 8 to 10 m / min. Film thickness is 21
0 μm, and the folding diameter was 300 mm. Seal width 10m
m and the upper and lower molds are heated at 165 ° C. to 190 ° C.
Heat-sealed at three places at ℃, outside dimension 200m in horizontal direction
m, a bag (bag) having a length of 250 mm was prepared. Then, a port made of polypropylene having a density of 0.910 g / cm ³ was heat-welded to the opening.

A polypropylene cap (density: 0.910 g) filled with 500 ml of a 10 w / v /% amino acid injection solution of amipalene from this port and fitted with a rubber stopper that passed the Japanese Pharmacopoeia (13th revision) / Cm ³ )
Was thermally welded. This package was left at room temperature for 24 hours after high-pressure steam sterilization at 118 ° C. for 40 minutes and subjected to the following experiment.

[0048]

Example 3 The following films were formed on a five-layer, five-layer water-cooled blown film molding machine. Innermost layer (50μ thick
The composition of the mixed resin of m) is a high-density polyethylene (trade name: Neozex, manufactured by Mitsui Petrochemical Industries, Ltd., density:
0.960 g / cm ³ , MI = 15), polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm ³ , MI = 8), styrene elastomer (trade name: Hibler, ( (Kuraray Co., Ltd., density: 0.940 g / cm ³ , MI = 0.7) at a weight ratio of 15:70:15. The resin composition of the inner adjacent layer (thickness 30 μm) is polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd.), density: 0.910 g / cm ³ ,
MI = 8) and a styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm)
³ , MI = 0.7) and modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.910)
g / cm ³ , MI = 8) were mixed at a weight ratio of 20:10:20. The mixed resin composition of the intermediate layer (40 μm thickness) is E
VOH (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Co., Ltd.)
Two kinds of resins, a ethylene copolymer molar ratio of 44%) and a styrene elastomer (trade name: Dinalon, manufactured by Nippon Synthetic Rubber Co., Ltd., density: 0.89 g / cm ³ , MI = 3.5) were mixed at a weight ratio of 9 : 1, the resin composition of the outer adjacent layer (thickness: 30 μm) is polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd.), density: 0.910 / cm ³ , MI
= 8) and a styrene-based elastomer (trade name: Dinalon, manufactured by Nippon Synthetic Rubber Co., Ltd., density: 0.89 g / cm)
³ , MI = 3.5) and modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.910)
g / cm ³ , MI = 8) were mixed at a weight ratio of 20:10:20. The composition of the mixed resin of the outermost layer (thickness: 50 μm)
High density polyethylene (trade name: Neozex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.960 g / cm ³ , MI)
= 15) and polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm ³ ,
MI = 8) and a styrene elastomer (trade name: Dinalon, manufactured by Nippon Synthetic Rubber Co., Ltd., density: 0.890 g)
/ Cm ³ , MI = 3.5) in a weight ratio of 15:70:15.
And Extruder temperature setting is 150 ℃ ~ 220 ℃,
Molding was performed at a mold temperature of 160 ° C to 225 ° C and a film take-up speed of 7 to 10 m / min. Film thickness is 200μ
m, the folding diameter was 330 mm. Using this blown film, the upper and lower molds were heat-sealed at three locations under a temperature condition of 165 ° C. to 190 ° C. so as to have a seal width of 10 mm.
m was prepared. Then, a port made of polypropylene having a density of 0.910 g / cm ³ was heat-welded to the opening. 10 from the port of this bag
A polypropylene cap (density: 0.910 g) filled with 500 ml of a w / v /% amino acid solution (amipalene) and fitted with a rubber stopper that has passed the Japanese Pharmacopoeia (13th revision)
/ Cm ³ ) was thermally welded. Put this bag at 121 ℃ ・ 20
After being subjected to high-pressure steam sterilization for 24 minutes, it was left at room temperature for 24 hours and subjected to the following experiment to determine the suitability of the manufactured bag.

[0049]

Example 4 The following film was formed on a five-layer, five-layer water-cooled blown film molding machine. Innermost layer (50μ thick
m) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density: 0.910 g /
cm ³ , MI = 3) and a styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g)
/ Cm ³ , MI = 0.7) in a weight ratio of 80:20. The resin composition of the inner adjacent layer (thickness 30 μm) is polypropylene (trade name: Hypol, Grand Polymer Co., Ltd.)
, Density: 0.910 g / cm ³ , MI = 3) and modified polyolefin (trade name: ADMER, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g / cm ³ , MI = 2) and styrene elastomer (Product name: High Blur,
Kuraray Co., Ltd., density: 0.940 g / cm ³ , MI =
0.7) was 30:50:20 by weight. The resin composition of the intermediate layer (thickness: 30 μm) is composed of EVOH (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Co., Ltd., ethylene copolymer molar ratio: 44%) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd.) , Density: 0.940 g / c
m ³ , MI = 0.7) in a weight ratio of 80:20. Outer adjacent layer (thickness: 30 μm) polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density: 0.910)
g / cm ³ , MI = 3) and a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd.), density: 0.1.
940 g / cm ³ , MI = 2) and a styrene elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density:
0.940 g / cm ³ , MI = 0.7) by weight ratio of 3
0:50:20. The resin composition of the outermost layer (thickness: 50 μm) is polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd.), density: 0.910 g / cm ³ , M
I = 3) and a styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ³ , M
I = 0.7) and linear low-density polyethylene (trade name: Ultex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g / cm ³ , MI = 2) in a weight ratio of 2
0:70:10. Extruder temperature setting is 160
C. to 220.degree. C., a mold temperature of 165.degree. C. to 225.degree. C., a film take-up speed of 9 to 12 m / min, and a folding diameter of 500 mm. Using this blown film, the outer dimensions are 200 mm in the lateral direction so that the seal width is 10 mm,
A bag (bag) having a length of 250 mm was prepared. And
A port made of polypropylene having a density of 0.910 g / cm ³ was heat-welded to the opening. 500 ml of 10 w / v /% amino acid solution (amipalen) from this port
The rubber stopper was filled and heat-sealed with a rubber stopper that passed the Japanese Pharmacopoeia (13th revision). The bag was left at room temperature for 24 hours after high-pressure steam sterilization at 118 ° C. for 40 minutes and subjected to the following experiment to determine the suitability of the manufactured bag.

[0050]

Example 5 The following film was formed on a five-layer, five-layer water-cooled blown film molding machine. Innermost layer (50μ thick
m) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density: 0.910 g /
cm ³ , MI = 3) and a styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g)
/ Cm ³ , MI = 0.7) and a linear low-density polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g / cm ³ , MI = 2) by weight ratio. 10: 5: 85. Inner adjacent layer (thickness 40μ)
m) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density: 0.910 g /
cm ³ , MI = 3) and modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940)
g / cm ³ , MI = 2) and a styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.9)
40 g / cm ³ , MI = 0.7) in a weight ratio of 15:80:
5 and mixed. The resin composition of the intermediate layer (25 μm thick)
EVOH (trade name: Soarnol, Nippon Synthetic Chemical Co., Ltd.)
, Ethylene copolymer molar ratio 44%) and a styrene elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ³ , MI = 0.7) at a weight ratio of 90:10. . Outer adjacent layer (thickness: 40 μm) polypropylene (trade name: Hypol, Grand Polymer Co., Ltd.)
, Density: 0.910 / cm ³ , MI = 3) and modified polyolefin (trade name: ADMER, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g / cm ³ , MI = 2) and styrene elastomer (Product name: High Blur,
Kuraray Co., Ltd., density: 0.940 g / cm ³ , MI =
0.7) was set to a weight ratio of 15: 80: 5. The resin composition of the outermost layer (thickness: 50 μm) is polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd.), density: 0.91
0 g / cm ³ , MI = 3) and a styrene elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.9)
40 g / cm ³ , MI = 0.7) and linear low-density polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g / cm ³ , MI = 2)
Was 10: 5: 85 by weight. Extruder temperature setting is 150 ° C to 220 ° C, mold temperature is 160 ° C to 225
The film was molded at a temperature of 9 to 13 m / min.
The folding diameter of the film was 500 mm. Using this blown film, the upper and lower molds were heat-sealed at 165 ° C. to 190 ° C. at three locations so as to have a seal width of 10 mm.
A 50 mm bag was prepared. Then, a port portion made of polyethylene having a density of 0.945 g / cm ³ was heat-welded to the opening. 1 from the port of this bag
A polyethylene cap (density: 0.945 g) filled with 500 ml of 0 w / v /% amino acid solution (amipalene) and fitted with a rubber stopper that has passed the Japanese Pharmacopoeia (13th revision)
/ Cm ³ ) was thermally welded. This package is at 118 ° C / 40
After being subjected to high-pressure steam sterilization for 24 minutes, it was left at room temperature for 24 hours and subjected to the following experiment to determine the suitability of the manufactured bag.

[0051]

Example 6 The following films were formed on a five-layer, five-layer air-cooled inflation film molding machine. Innermost layer (thickness 30μ)
m) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910 g / c)
m ³ , MI = 4) and styrene elastomer (trade name:
Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / c
m ³ , MI = 0.7) in a weight ratio of 80:20. The resin composition of the inner adjacent layer (thickness 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industry Co., Ltd.)
A density of 0.910 g / cm ³ , MI = 3) and a styrene elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ³ , MI = 0.7) are 90:10 by weight ratio. And The resin composition of the intermediate layer (thickness: 40 μm) is composed of EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio: 44%) and styrene elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd.) : 0.
940 g / cm ³ , MI = 0.7) in a weight ratio of 95: 5.
And The resin composition of the outer adjacent layer (thickness: 30 μm) is composed of a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.910 g / cm ³ , MI = 3) and a styrene elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ³ , MI = 0.7)
Was set to 90:10 by weight ratio. Outermost layer (50μm thickness)
The resin composition is polypropylene (trade name: Hypol,
Grand Polymer Co., Ltd., density 0.910g / c
m ³ , MI = 6) and a styrene-based elastomer (trade name:
Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / c
m ³ , MI = 0.7) in a weight ratio of 90:10. The temperature setting of the extruder is 170 to 220 ° C, the mold temperature is 180 to 230 ° C, and the film take-up speed is 7.5 to
Molding was performed with a folding diameter of 520 mm at 12 m / min. Using this blown film, a bag having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was prepared so that the seal width was 10 mm. In the opening, polypropylene (trade name: Hypol, Grand Polymer Co., Ltd.)
Ltd., density ^{0.910g / cm 3, MI = 6} ) and styrene-based elastomer (trade name: HYBRAR, manufactured by Kuraray Co., Ltd., density: at ^{0.940g / cm 3, MI = 0.7} ) by weight ratio 90 : 10 and the injection molded port was heat welded. 10w / from this port
500 ml of v /% amino acid solution (amipalen) is filled,
After being subjected to high-pressure steam sterilization at 118 ° C. for 40 minutes, the bag was left at room temperature for 24 hours and subjected to the following experiment to determine the suitability of the manufactured bag.

[0052]

Example 7 The following films were formed on a five-layer, five-layer air-cooled inflation film molding machine. Innermost layer (thickness 30μ)
m) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910 g / c)
m ³ , MI = 4) and styrene elastomer (trade name:
Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / c
m ³ , MI = 0.7) in a weight ratio of 80:20. The resin composition of the inner adjacent layer (thickness 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industry Co., Ltd.)
A density of 0.890 g / cm ³ , MI = 3) and a styrene elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ³ , MI = 0.7) are 90:10 by weight ratio. And The resin composition of the intermediate layer (thickness: 40 μm) is composed of EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio: 44%) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd.) : 0.
940 g / cm ³ , MI = 0.7) in a weight ratio of 95: 5.
And The resin composition of the outer adjacent layer (thickness 30 μm) was a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.890 g / cm ³ , MI = 3). The resin composition of the outermost layer (thickness: 50 μm) is polypropylene (trade name: Hypol, Grand Polymer Co., Ltd.)
Manufactured, density 0.910 g / cm ³ , MI = 4). The temperature setting of the extruder is 170 to 220 ° C, the mold temperature is 180 to 230 ° C, and the film take-up speed is 9 to 12.
m / min, and formed with a folding diameter of 520 mm. Using this blown film, a bag having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was prepared so that the seal width was 10 mm. In the opening, polypropylene (trade name: Hypol, Grand Polymer Co., Ltd.)
Ltd., density ^{0.910g / cm 3, MI = 6} ) and styrene-based elastomer (trade name: HYBRAR, manufactured by Kuraray Co., Ltd., density: at ^{0.940g / cm 3, MI = 0.7} ) by weight ratio 90 : 10 and the injection molded port was heat welded. 10w / from this port
500 ml of v /% amino acid solution (amipalen) is filled,
After being subjected to high-pressure steam sterilization at 118 ° C. for 40 minutes, the bag was left at room temperature for 24 hours and subjected to the following experiment to determine the suitability of the manufactured bag.

[0053]

Example 8 The following film was formed on a five-layer, five-layer air-cooled inflation film molding machine. Innermost layer (50μ thick
m) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910 g / c)
m ³ , MI = 4) and styrene elastomer (trade name:
Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / c
m ³ , MI = 0.7) in a weight ratio of 80:20. The resin composition of the inner adjacent layer (thickness 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industry Co., Ltd.)
The density was 0.910 g / cm ³ and MI = 3). The resin composition of the intermediate layer (thickness: 20 μm) is EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio: 44)
%) And a styrene-based elastomer (trade name: Hibler,
Kuraray Co., Ltd., density: 0.940 g / cm ³ , MI =
0.7) was 95: 5 by weight. Outer adjacent layer (thickness 3
0 μm) is a modified polyolefin (trade name:
Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.910
g / cm ³ , MI = 3). Outermost layer (50μ thick
m) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910 g / c)
m ³ , MI = 6) and a styrene-based elastomer (trade name:
Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / c
m ³ , MI = 0.7) in a weight ratio of 90:10. The temperature setting of the extruder is 170 to 220 ° C, the mold temperature is 180 to 230 ° C, and the film take-up speed is 7.5 to
Molding was performed with a folding diameter of 520 mm at 12 m / min. Using this blown film, a bag having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was prepared so that the seal width was 10 mm. In the opening, polypropylene (trade name: Hypol, Grand Polymer Co., Ltd.)
Ltd., density ^{0.910g / cm 3, MI = 6} ) and styrene-based elastomer (trade name: HYBRAR, manufactured by Kuraray Co., Ltd., density: at ^{0.940g / cm 3, MI = 0.7} ) by weight ratio 90 : 10 and the injection molded port was heat welded. 10w / from this port
500 ml of v /% amino acid solution (amipalen) is filled,
After being subjected to high-pressure steam sterilization at 118 ° C. for 40 minutes, the bag was left at room temperature for 24 hours and subjected to the following experiment to determine the suitability of the manufactured bag.

[0054]

Example 9 The following films were formed on a five-layer, five-layer water-cooled inflation film molding machine. Innermost layer (thickness 60μ)
m) is made of polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.930 g /
cm ³ , MI = 2.0) and a styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940)
g / cm ³ , MI = 0.7) in a weight ratio of 95: 5. The resin composition of the inner adjacent layer (thickness 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.930 g / cm ³ , MI = 2.0)
And The resin composition of the intermediate layer (thickness 30 μm) is EVO
H (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd.)
Ethylene copolymer molar ratio 44%) and styrene elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density:
0.940 g / cm ³ , MI = 0.7) by weight ratio of 9
0:10. The resin composition of the outer adjacent layer (thickness 30 μm) is made of nylon (trade name: Novamid, Mitsubishi Kasei Co., Ltd.)
And a density of 1.140 g / cm ³ ). The resin composition of the outermost layer (thickness: 50 μm) is polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.93)
0 g / cm ³ , MI = 3) and a styrene-based elastomer (trade name: Dinalon, manufactured by Nippon Synthetic Rubber Co., Ltd., density:
0.910 g / cm ³ , MI = 0.7) in a weight ratio of 9
0:10. The temperature setting of the extruder is 170 ℃ ～ 2
Molding was performed at 50 ° C, a mold temperature of 180 to 265 ° C, a film take-up speed of 10 to 12 m / min, and a folding diameter of 520 mm. Using this blown film, a bag having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was prepared so that the seal width was 10 mm. Then, polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.945 g / cm ³ , M
I = 8) and a styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ³ , M
I = 0.7) at a weight ratio of 90:10, and the injection-molded port was heat-sealed. 5 w / v /% amino acid solution (amipalen)
After filling with 00ml and sterilizing by high pressure steam at 118 ° C for 40 minutes, 2
The bag was left at room temperature for 4 hours and subjected to the following experiment to determine the suitability of the manufactured bag.

[0055]

Example 10 The following film was formed on a five-layer, five-layer water-cooled inflation film molding machine. Innermost layer (50μ thick
m) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910 g / c)
m ³ , MI = 4) and styrene elastomer (trade name:
Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / c
m ³ , MI = 0.7) in a weight ratio of 80:20. The resin composition of the inner adjacent layer (thickness 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industry Co., Ltd.)
The density was 0.890 g / cm ³ and MI = 5.7). The resin composition of the intermediate layer (thickness: 40 μm) includes EVOH (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer molar ratio: 44%) and styrene-based elastomer (trade name: Hibler, Kuraray Co., Ltd.) Made, density: 0.940
g / cm ³ , MI = 0.7) in a weight ratio of 90:10. The resin composition of the outer adjacent layer (thickness 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.890 g / cm ³ , MI = 5.7)
And The resin composition of the outermost layer (thickness: 20 μm) was polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm ³ , MI = 4). The temperature setting of the extruder is 170 to 220 ° C, the mold temperature is 180 to 230 ° C, and the film take-up speed is 9
Molded at a folding diameter of 520 mm at １２12 m / min. Using this blown film, the outer dimensions are 200 mm in the horizontal direction and 250 mm in the vertical direction so that the seal width is 10 mm.
Was prepared. In the opening, polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm ³ , MI = 6) and styrene elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0) 0.940 g / cm ³ , MI = 0.7)
Was blended at a weight ratio of 90:10, and the injection-molded port was heat-sealed. 10 from this port
500 ml of a w / v /% amino acid solution (amipalen) was filled, and after being subjected to high-pressure steam sterilization at 118 ° C. for 40 minutes, allowed to stand at room temperature for 24 hours, and subjected to the following experiment to determine the suitability of the manufactured bag.

[0056]

Example 11 The following film was formed on a five-layer, five-layer water-cooled inflation film molding machine. Innermost layer (50μ thick
m) is a resin composition of polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g /
cm ³ , MI = 3) and an ethylene α-olefin copolymer (trade name: Tuffmer, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.880 g / cm ³ , MI = 4) in a weight ratio of 8
0:20. The resin composition of the inner adjacent layer (thickness 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.940 g / cm ³ , MI =
1.3). The resin composition of the intermediate layer (thickness: 20 μm) is composed of EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio: 44%) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd.) : 0.
940 g / cm ³ , MI = 0.7) in a weight ratio of 90: 1.
0 was set. The resin composition of the outer adjacent layer (thickness: 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g / cm ³ , MI = 1.
3). The resin composition of the outermost layer (thickness 30 μm) was polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm ³ , MI = 6). The temperature setting of the extruder is 170 to 220 ° C, the mold temperature is 180 to 230 ° C, and the film take-up speed is 1
Molding was performed at a folding diameter of 520 mm at 0 to 12 m / min. Using this blown film, the outer dimensions are 200 mm in the horizontal direction and 250 m in the vertical direction so that the seal width is 10 mm.
m was prepared. Then, polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.945 g / cm ³ , MI = 6) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd.) (Density: 0.940 g / cm ³ , MI = 0.7)
Was blended at a weight ratio of 90:10, and the injection-molded port was heat-sealed. 10 from this port
500 ml of a w / v /% amino acid solution (amipalen) was filled, and after being subjected to high-pressure steam sterilization at 118 ° C. for 40 minutes, allowed to stand at room temperature for 24 hours, and subjected to the following experiment to determine the suitability of the manufactured bag.

[0057]

Example 12 The following films were formed on a five-layer, five-layer water-cooled inflation film molding machine. Innermost layer (thickness 30μ)
m) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910 g / c)
m ³ , MI = 4) and an ethylene α-olefin copolymer (trade name: Tuffmer, manufactured by Mitsui Petrochemical Industries, Ltd., density:
0.880 g / cm ³ , MI = 4.0) in a weight ratio of 9
0:10. The resin composition of the inner adjacent layer (thickness 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.890 g / cm ³ , MI =
5.7). The resin composition of the intermediate layer (thickness: 30 μm) is composed of EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio: 44%) and styrene elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd.) : 0.
940 g / cm ³ , MI = 0.7) in a weight ratio of 95: 5.
And The resin composition of the outer adjacent layer (thickness: 30 μm) was nylon (trade name: Novamimid, manufactured by Mitsubishi Kasei Corporation, density: 1.152 g / cm ³ ). Outermost layer (50μ thick
m) is a resin composition of polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g /
cm ³ , MI = 3). Extruder temperature setting is 1
50 ° C. to 250 ° C., mold temperature 170 ° C. to 265 ° C., film take-off speed 10 to 14 m / min, folding diameter 520
mm. Using this blown film, the outer dimension is set to 20 mm in the lateral direction so that the seal width becomes 10 mm.
A bag (bag) having a length of 0 mm and a length of 250 mm was prepared.
Then, polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910 g / c)
m ³ , MI = 6) and a styrene-based elastomer (trade name:
Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / c
m ³ , MI = 0.7) were blended at a weight ratio of 90:10, and the injection-molded port was heat-sealed.
500 ml of 10 w / v /% amino acid solution (amipalen) was filled from this port portion, and after high-pressure steam sterilization at 118 ° C. for 40 minutes, it was allowed to stand at room temperature for 24 hours. Judged.

[0058]

Example 13 The following films were formed on a five-layer, five-layer air-cooled inflation film molding machine. Innermost layer (thickness 40μ)
m) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910 g / c)
m ³ , MI = 4) and a polyptene polymer (trade name: Buron, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.89)
0 g / cm ³ , MI = 0.2) in a weight ratio of 70:30. The resin composition of the inner adjacent layer (thickness: 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industry Co., Ltd., density: 0.890 g / cm ³ , MI = 5.7)
And The resin composition of the intermediate layer (thickness 30 μm) is EVO
H (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd.)
Ethylene copolymer molar ratio 44%) and styrene elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density:
0.940 g / cm ³ , MI = 0.7) by weight ratio of 9
5: 5. The resin composition of the outer adjacent layer (thickness: 30 μm) is made of nylon (trade name: Novamimid, Mitsubishi Kasei Co., Ltd.)
And a density of 1.152 g / cm ³ ). The resin composition of the outermost layer (thickness: 30 μm) is polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.93)
0 g / cm ³ , MI = 2). Extruder temperature setting is 150 ° C to 250 ° C, mold temperature is 160 ° C to 265
C., a film take-up speed of 10 to 12 m / min and a folding diameter of 520 mm. Using this blown film, a bag having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was prepared so that the seal width was 10 mm. Then, polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910)
g / cm ³ , MI = 6) and a styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940)
g / cm ³ , MI = 0.7) at a weight ratio of 90:10, and the injection-molded port was heat-sealed. 500 ml of 10 w / v /% amino acid solution (amipalen) was filled from this port portion, and after high-pressure steam sterilization at 118 ° C. for 40 minutes, it was allowed to stand at room temperature for 24 hours. Judged.

[0059]

Example 14 The following films were formed on a five-layer, five-layer air-cooled inflation film molding machine. Innermost layer (thickness 40μ)
m) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910 g / c)
m ³ , MI = 4) and a polyptene polymer (trade name: Buron, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.89)
0 g / cm ³ , MI = 0.2) in a weight ratio of 70:30. The resin composition of the inner adjacent layer (thickness: 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industry Co., Ltd., density: 0.890 g / cm ³ , MI = 5.7)
And The resin composition of the intermediate layer (thickness 30 μm) is EVO
H (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd.)
Ethylene copolymer molar ratio 44%) and styrene elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density:
0.940 g / cm ³ , MI = 0.7) by weight ratio of 9
5: 5. The resin composition of the outer adjacent layer (thickness 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.890 g / cm ³ , MI =
5.7). The resin composition of the outermost layer (thickness: 30 μm) is polypropylene (trade name: Hypol, manufactured by Mitsui Petrochemical Industries, Ltd.), density: 0.910 g / cm ³ , MI =
4). Extruder temperature setting is 150 ℃ ~ 220
C., a mold temperature of 160 to 235 ° C., a film take-up speed of 7 to 11 m / min, and a folding diameter of 520 mm.
Using this blown film, seal width 10
mm, the outer dimensions are 200 mm in the horizontal direction and 2 in the vertical direction.
A 50 mm bag was prepared. Then, polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm ³ , MI = 6) is formed in the opening.
And styrene-based elastomer (trade name: Hibler,
Kuraray Co., Ltd., density: 0.940 g / cm ³ , MI =
0.7) was blended at a weight ratio of 90:10, and the injection-molded port was heat-sealed. A 10 w / v /% amino acid solution (amipalen) is supplied from this port section to 500
After filling in the solution and sterilizing it by high-pressure steam at 118 ° C. for 40 minutes, it was left at room temperature for 24 hours and subjected to the following experiment to determine the suitability of the manufactured bag.

[0060]

Example 15 A medical container according to the present invention was obtained in the same manner as in Example 9 except that the outermost layer was changed from a mixed resin of polyethylene and styrene resin to polypropylene.

[0061]

Example 16 Example 13 was the same as Example 13 except that the structure of the innermost layer was changed from a mixed resin of polypropylene and polybutene to polypropylene and an ethylene α-olefin copolymer, and the structure of the outermost layer was changed from polyethylene to polypropylene. A medical container of the present invention having a configuration was obtained.

[0062]

Example 17 Example 12 was the same as Example 12 except that the innermost layer was changed from a mixed resin of polypropylene and ethylene α-olefin copolymer to a mixed resin of polyethylene and ethylene α-olefin copolymer. The medical container of the present invention was obtained.

[0063]

Control Example 1 Control film 1 [thickness 200 μm: layer constitution PET / adhesive / nylon / EVOH (thickness 30 μm,
Trade name: EVAL, manufactured by Kuraray Co., Ltd.) / Adhesive polyethylene (Admer) / linear L-LDPE (density: 0.9
40 g / cm ³ ), and heat-sealed (with a width of 10 g / cm ³ ).
mm) in outer dimensions of 200 mm in the horizontal direction and 250 mm in the vertical direction
Was prepared. And the density in the opening:
A port made of polyethylene of 0.945 g / cm ³ was heat welded. 10w / v from the port of this bag
/ Ml amino acid solution (amiparen), filled with a polyethylene stopper (density: 0.945 g / c) fitted with a rubber stopper that passed the Japanese Pharmacopoeia (13th revision)
m ³ ) was thermally welded. This bag was left at room temperature for 24 hours after high-pressure steam sterilization at 121 ° C. for 20 minutes and subjected to the following experiment.

[0064]

Comparative Example 2 Control film 2 [thickness 220 μm: layer structure, polypropylene (density: 0.910 g / cm ³ ) /
Amorphous polypropylene (density: 0.890 g / cm ³ )
/ Adhesive polypropylene (Admer) / EVOH (thickness 30 μm, trade name: Soarnol, Nippon Synthetic Chemical Co., Ltd.)
) / Adhesive polypropylene (Admer) / polypropylene (density: 0.910 g / cm ³ ) to form a bag (bag) having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction by heat sealing (10 mm in width). . Then, a port made of polypropylene having a density of 0.910 g / cm ³ was heat-welded to the opening. A 10 w / v /% amino acid solution (amipalene) was added to 500 parts from the port of this bag.
ml of polypropylene cap fitted with a rubber stopper that passed the Japanese Pharmacopoeia (13th revision) (density: 0.
910 g / cm ³ ). 115 this bag
After leaving it at room temperature for 24 hours after autoclaving at 40 ° C for 40 minutes,
The following experiment was performed.

1) Delamination after sterilization (number of samples: 100)

[0066]

[Table 1]

2) Stability test result (60 ° C., 75% R)
H, 4 weeks, number of samples = 5) 24 hours after the end of sterilization, the above-mentioned production samples were subjected to the conditions (60 ° C., 7
(5% RH) was stored for 4 weeks, and the stability of the content drug was examined. The content was determined by examining the individual content of amino acids, and any of those which showed a decrease in content was judged to be unacceptable.

[0068]

[Table 2]

3) Dropping of a single item 24 hours after the end of sterilization, the various bags produced as described above were put into a low temperature / high temperature tank BNC-1 manufactured by Tabai Espec Co., Ltd.
20 (set at 8 ° C.) for 24 hours. After confirming that the product temperature was 10 ° C. or less, the sample was subjected to a drop test. The drop test condition was to drop from a height of 60 cm.

The single item drop test was evaluated by visually checking the following three points: (1) the presence or absence of a scratch on the bag leading to the pinhole, (2) the presence or absence of an abnormality in the bag and the seal portion, and (3) the presence or absence of leakage of the solution in the inside. .

The control examples 1 and 2 used in the test all had delamination after sterilization.

[0072]

[Table 3]

[0073]

According to the present invention, a multilayer film having all the quality properties desired for medical use, such as transparency, impact resistance, flexibility, gas barrier properties, low-temperature strength, heat resistance and stain resistance, is provided. Can be provided.

[Brief description of the drawings]

FIG. 1 is a plan view of the medical container of the present invention.

FIG. 2 is an enlarged cross-sectional view showing one embodiment of the multilayer film constituting the medical container of the present invention.

FIG. 3 is an enlarged sectional view showing another embodiment.

FIG. 4 is an enlarged sectional view showing still another embodiment.

[Explanation of symbols]

 Reference Signs List 1 intermediate layer 2 adjacent layer 3 innermost layer 4 outermost layer 5 adhesive layer

Claims (17)

[Claims] In a medical container comprising a multilayer film, the multilayer film includes an intermediate layer composed of a mixed resin of an ethylene / vinyl alcohol copolymer and a styrene-based resin. An inner adjacent layer is formed so as to be in direct contact with the inner adjacent layer, and the inner adjacent layer is formed of a resin containing a modified polyolefin as a main component, a first mixed resin containing a modified polyolefin and a styrene resin as main components, or a polypropylene resin and a styrene resin. A medical container comprising a second mixed resin containing a resin as a main component. 2. The mixed resin constituting the intermediate layer is ethylene.
2. The medical container according to claim 1, comprising at least 50% by weight of a vinyl alcohol copolymer and at least 5% by weight of a styrene resin. 3. The medical container according to claim 1, wherein the first mixed resin constituting the inner adjacent layer contains at least 10% by weight of a modified polyolefin and at least 5% by weight of a styrene-based resin. . 4. The medical device according to claim 1, wherein the second mixed resin constituting the inner adjacent layer contains at least 10% by weight of a polypropylene-based resin and at least 5% by weight of a styrene-based resin. container. 5. The second mixed resin constituting the inner adjacent layer includes a third component in addition to two components of a polypropylene resin and a styrene resin.
5. The medical container according to claim 1, further comprising a modified polyolefin as a component in an amount not exceeding 20% by weight. 6. The medical container according to claim 1, wherein an outer adjacent layer is formed on an outer surface side of the intermediate layer. 7. The outer adjacent layer comprises a resin containing a modified polyolefin as a main component, a first mixed resin containing a modified polyolefin and a styrene resin as main components, or a polypropylene resin and a styrene resin as main components. The medical container according to claim 6, wherein the medical container is made of a second mixed resin. 8. The medical container according to claim 6, wherein the outer adjacent layer is made of nylon. 9. An innermost layer as a heat seal layer made of a mixed resin containing a polypropylene-based resin and a styrene-based resin as main components is formed on the inner surface side of the inner adjacent layer. The medical container according to any one of claims 1 to 8, wherein 10. The medical container according to claim 9, wherein the innermost layer contains a thermoplastic resin other than the two components as the third component in addition to the two components. 11. The medical container according to claim 1, wherein the outermost layer as a protective layer is formed in contact with the outside of the intermediate layer. 12. The method according to claim 11, wherein the outermost layer is composed of a resin containing polyolefin as a main component, and the outermost layer is bonded to the intermediate layer via an adhesive or an adhesive layer. Medical container. 13. The medical container according to claim 6, wherein the outermost layer is formed in contact with the outside of the outer adjacent layer. 14. The medical container according to claim 13, wherein the outermost layer contains a resin component constituting an outer adjacent layer as a main component. 15. The medical container according to claim 14, wherein the outermost layer is made of a mixed resin containing a polypropylene resin and a styrene resin as main components. 16. The medical container according to claim 15, wherein the resin component constituting the outermost layer contains a thermoplastic resin other than the above resin components in addition to the above resin components. 17. An outermost layer is formed integrally with an outer adjacent layer by extrusion molding.
7. The medical container according to any one of 6.