JP2000033674A - Multilayered film and product thereof - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a multilayered film having not only gas barrier properties but also all of quality capacities desired as a medical use such as transparency, flexibility, impact resistance, low temp. strength, heat resistance or antistaining properties and a product thereof. SOLUTION: A first layer 1 as the innermost layer and the third layer 3 comprising an ethylene/vinyl alcohol copolymer laminated to the outside of the first layer 1 through a second layer 2 being an adhesive layer are at least provided and the second layer 2 as the adhesive layer is constituted of modified polyolefin and the first layer 1 as the innermost layer is constituted of a mixed resin containing a polypropylene resin or a polyethylene resin and a styrenic resin.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a multilayer film, and more particularly to a product applied to the storage of a drug which is liable to be deteriorated with time due to oxidation, moisture absorption, etc. The present invention relates to a multilayer film useful for forming an outer bag applied to a multilayer film.

[0002]

2. Description of the Related Art Conventionally, pharmaceuticals 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 during use of ampoules. 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 vibrations 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 discarding 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 due to the following problems (1) and (2). (1) When the necessary high-pressure steam sterilization treatment is performed when storing a sterile preparation, delamination occurs and the performance as a container cannot be maintained. (2) Since the film itself is hard, there is a problem in strength, particularly impact resistance and flexibility. However, among the above-mentioned gas barrier films, an aluminum laminated film can solve the above problems (1) and (2). There is a problem that the adhesive component is transferred to the contents side through the plastic film and contaminates the contents, which is difficult to put to practical use like the gas barrier film.

[0007]

DISCLOSURE OF THE INVENTION The present invention eliminates all of the above-mentioned conventional problems and provides medical barriers 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 multilayer film having all the desired quality performances and products thereof, for example, medical containers and outer bags for storing medical containers.

[0008]

According to the present invention, there is provided an ethylene / vinyl alcohol copolymer laminated via a first layer as an innermost layer and a second layer as an adhesive layer outside the first layer. A second layer as an adhesive layer is made of a modified polyolefin, and the first layer as the innermost layer is a mixture containing a polypropylene resin and / or a polyethylene resin and a styrene resin. The present invention relates to a multilayer film comprising a resin and a product thereof.

In the present invention, the mixed resin constituting the first layer preferably contains 50 to 99% by weight of a polypropylene resin or a polyethylene resin and 1 to 50% by weight of a styrene resin. .

Further, the mixed resin constituting the first layer includes
As a third component in addition to the ingredients, polybutylene te emissions, ethylene · alpha
At least one selected from the group consisting of an olefin copolymer and a propylene / α-olefin copolymer, in an amount of 49% by weight;
May be included in a range not exceeding.

A fourth layer as an adhesive layer made of a modified polyolefin or nylon is provided on the outer surface side of the third layer,
A fifth layer as a protective layer containing a polypropylene-based resin or a polyethylene-based resin as a main component can be formed.

[0012] The fifth layer as a protective layer, at least one of the additional components include styrene-based resin, polybutylene te emissions, ethylene · alpha-olefin copolymer, selected from the group consisting of propylene · alpha-olefin copolymer May be contained.

The outermost layer (the third layer in the case of a three-layer structure, the fifth layer in the case of a five-layer structure) may be provided with a coating layer of an ultraviolet absorber to protect the contents from ultraviolet rays. As an ultraviolet absorber, for example, see soap 201 (trademark)
Yoshitomi Pharmaceutical Co., Ltd.), TinuvinP (trademark, manufactured by Nippon Ciba-Gaiky Co., Ltd.) and the like can be used.

[0014]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of the present invention will be described below with reference to the accompanying drawings. FIG. 1 shows a product composed of the multilayer film of the present invention, for example, a medical container A, and FIG. The 2-4 show various embodiments of the present invention the multilayer film A _1.

FIG. 2 shows a three-layered multilayer film having the most basic layer configuration of the present invention.
₁ is a first layer 1 as an innermost layer, and a second layer 2 as an adhesive layer
And ethylene-vinyl alcohol copolymer (hereinafter EVO)
H). The first layer 1 constitutes the innermost layer of the product, for example, the medical container A, and is a layer which is in direct contact with the storage article, and the third layer 3 constitutes the outermost layer of the medical container A.

The EVOH constituting the third layer 3 has excellent gas barrier properties, and functions to impart gas barrier properties to its products, such as medical containers and outer bags.

The thickness of the third layer 3 is not particularly limited.
If the VOH is made of a hard and thick material, the rigidity of the multilayer film and its product may be unnecessarily increased. Therefore, it is preferable that the VOH be as thin as possible without impairing the gas barrier properties. , Preferably 20
It is appropriately selected and determined from the range of about 30 μm.

The first layer 1 as the innermost layer has a first mixed resin mainly composed of two components of a polypropylene-based resin and a styrene-based resin, and a two-component mainly composed of a polyethylene-based resin and a styrene-based resin. The second mixed resin or the third mixed resin mainly composed of three components of polypropylene resin, polyethylene resin and styrene resin.

Among the constituent resins of the first layer 1, a polypropylene resin (first and third mixed resin) or a polyethylene resin (second and third mixed resin) is excellent in flexibility and impact resistance, while styrene resin ( The first to third mixed resins) are excellent in heat resistance and elasticity at low temperatures. Therefore, the first layer 1 composed of these mixed resins is excellent in flexibility, impact resistance, heat resistance and low-temperature strength. Become.

The content of the polypropylene-based resin and / or the polyethylene-based resin in the first to third mixed resins can be selected from a wide range. %, And it is usually appropriately selected and determined from a range of about 50 to 99% by weight, preferably about 70 to 95% by weight.

On the other hand, the styrene resin must contain at least 1% by weight in order to secure heat resistance and low-temperature strength, and is usually 1 to 50% by weight, preferably 5 to 50% by weight.
It is appropriately selected and determined from the range of 20.

In the first to third mixed resins, as other components,
At least one resin selected from the group consisting of polybutene, ethylene / α-olefin copolymer, and propylene / α-olefin copolymer can be added in a range not exceeding 49% by weight based on the total weight of the mixed resin. . By adding such other components, the blocking resistance and the easy peel sealing property of the first layer 1 can be improved.

The first layer 1 is excellent in flexibility, impact resistance and low-temperature strength, is hard in material, and protects the third layer 3 (EVOH) from the inside, which is liable to generate pinholes and the like when subjected to an impact. You are. Also, the third layer 3 is softened by its flexibility.

The thickness of the first layer 1 is substantially equal to or greater than the thickness of the third layer 3 in order to protect the third layer 3 from impact or the like and to reduce the hardness of the third layer 3. It is preferably slightly larger, usually 20 to 60 μm, preferably 30 to 50 μm.
It is appropriately selected and determined from the range of μm in consideration of the thickness of the third layer 3.

The second layer 2 as an adhesive layer is composed of a modified polyolefin. Since the modified polyolefin has a polar functional group such as a hydroxyl group (-OH) found in EVOH in its molecule, the EVOH of the third layer 3
And the first layer 1 as the innermost layer
And the presence of a polyolefin-based resin which is a common component, the adhesion to the first layer 1 is also improved. Adhesive strength between them can be secured.

The thickness of the second layer 2 is not particularly limited as long as it can function as an adhesive layer.

The resin component constituting the first to third layers 3 is made of a plasticizer (for example, DOP) in order to obtain stain resistance.
It does not contain any additives that may cause contamination, such as anti-blocking agents (for example, antioxidants) and nylon (adipic acid, caprolactam). In addition, nylon is E
Although sometimes used as a quality improver for VOH, in the present invention, EVOH is used without containing nylon.

As shown in FIG. 3, a fifth layer 5 as a protective layer can be formed outside the third layer via a fourth layer 4 as an adhesive layer.

In this case, it is necessary that the fifth layer 5 contains, as a main component, at least 50% by weight of a polypropylene resin or a polyethylene resin, for example.
As described above, the polypropylene-based resin or the polyethylene-based resin is excellent in transparency, flexibility, and impact resistance, and functions to protect the EVOH of the third layer 3 from external impact and the like.

In order to improve heat resistance and low-temperature strength, a styrene-based resin can be added to and mixed with the polypropylene-based resin or the polyethylene-based resin constituting the fifth layer 5, for example, in the range of 20 to 30% by weight. . In order to improve blocking resistance, polybutene, ethylene
At least one resin selected from the group consisting of olefin copolymers and propylene / α-olefin copolymers, in the case of polybutene in an amount not exceeding 40% by weight;
-In the case of an olefin copolymer, it can be added and mixed within a range not exceeding 5% by weight.

The fourth layer 4 as an adhesive layer is composed of a modified polyolefin or a nylon resin. The modified polyolefin is, as described above, a third layer 5 and a fifth layer 5.
And a sufficient interlayer adhesive strength can be obtained.
Also, the nylon-based resin has an adhesive property to the third layer 5 and the fifth layer 5, and in this case also, a sufficient interlayer adhesive strength can be obtained.

Incidentally, in the nylon resin, adipic acid, caprolactam and the like, which are components thereof, may become contaminants. Therefore, there is no problem even if a nylon resin is used as the fourth layer 4.

When the fourth layer 4 is made of a nylon resin, the resin has excellent flexibility and impact resistance, and can also be used as a protective layer.

The thickness of the fourth layer may be determined according to the second layer, and the thickness of the fifth layer may be determined according to the first layer.

The multilayer film having a three-layer structure shown in FIG. 2 and the multilayer film having a five-layer structure shown in FIG. 3 can be manufactured by applying a co-extrusion molding method. When a multilayer film having a five-layer structure is manufactured by applying a co-extrusion molding method, the amount of an additive such as polybutene is adjusted so as to make the melting point of the first layer lower than that of the fifth layer, thereby forming a film. Performance can be improved.

FIG. 4 shows a multilayer film having a three-layer structure shown in FIG. 2, in which an outer layer 6 as a protective layer is laminated outside the third layer by applying a dry lamination method or a heat lamination method. Shows the case. In this case, the outer layer 6
May be formed, for example, from the same resin as the fifth layer to the same thickness.

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.

As the polypropylene-based resin or polyethylene-based resin, homopolymer (including amorphous and low-crystalline) and copolymer (for example, random polymer,
Block polymer).

The multi-layer film of the present invention and its products, for example, bags for medical containers, outer packaging, etc., constitute the third layer 3 of EV.
Has excellent gas barrier properties unique to OH.

Further, the first layer 1, which is the innermost layer, is excellent in flexibility, impact resistance and low-temperature strength, and functions to reduce the impact. Cracks do not occur, and gas barrier properties can be stably maintained for a long period of time. Such performance can be further improved by providing the fifth layer 5 (see FIG. 3) or the outer layer 6 (see FIG. 4) as a protective layer.

Further, the first layer 1 has an improved low-temperature strength and heat resistance due to the styrene resin contained therein, and has a large adhesive strength between the layers by acting as an adhesive layer of the modified polyolefin constituting the second layer 2. In particular, the five-layer structure (see FIG. 3) that protects the third layer 3 from inside and outside eliminates the risk of delamination during high-pressure steam sterilization. Incidentally, in the case of the three-layer structure in which the EVOH layer (third layer) is the outermost layer, there is no protection against water vapor from the outer layer side. Therefore, instead of high-pressure steam sterilization, H ₂ O ₂ , ozone sterilization or the like can be applied. preferable.

Further, the first to third layers do not contain any components that may become contaminants, and the third layer 3 has a function of preventing the transfer of contaminants from the outside to the inside due to its excellent barrier properties. As a result, the contents are not contaminated by contaminants, and anti-staining properties can be obtained.

Furthermore, the various resin components constituting each layer are all transparent, and the transparency required for the product, for example, a medical container or an outer bag can be secured.

Hereinafter, examples of the present invention will be described, and control examples and comparative examples will be described.
The results of the comparative test are as follows. (Example 1) Five-layer, five-layer air-cooled blown film
The following multilayer film of the present invention was formed on a mold machine. First layer
(Thickness 50μm) resin composition is polypropylene (product
Name: Hypol, Grand Polymer Co., Ltd., density 0.9
10g / cm ^Three , MI = 4) and a styrenic polymer (d)
(Lastmer) (trade name: Hibler, manufactured by Kuraray Co., Ltd.)
Degree: 0.940 g / cm ^Three , MI = 0.7) by weight ratio
80:20. Resin composition of second layer (thickness 30μm)
Is a modified polyolefin (trade name: Admer, Mitsui Oil
Made by Chemical Industry Co., Ltd., density 0.890 g / cm ^Three , MI =
5.7). The resin composition of the third layer (thickness 30 μm)
Is EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd.)
(Lens copolymer molar ratio: 44%). 4th layer (thickness 30
μm) resin composition is modified polyolefin (trade name: A
Domer, manufactured by Mitsui Petrochemical Industry Co., Ltd., density 0.890 g /
cm ^Three , MI = 5.7). Fifth layer (thickness 50μ)
m) is made of polypropylene (trade name: HiPo
Manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm
^Three , MI = 6) and styrenic polymer (elastomer)
(Product name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.94
0 g / cm ^Three , MI = 0.7) in a weight ratio of 90:10.
did. The temperature setting of the extruder is 170 ° C to 220 ° C, gold
The mold temperature is 180 to 230 ° C, and the film take-off speed is
Molding was performed at a folding diameter of 300 mm at 8 to 14 m / min. This
Using a blown film, seal width 10mm
To be outside, 200mm in horizontal direction and 250m in vertical direction
m was prepared. And a polyp in the opening
Lopylene (trade name: Hypol, Grand Polymer Co., Ltd.)
Made, density 0.910g / cm ^Three , MI = 6) and styrene
Polymer (elastomer) (trade name: Hibler, Inc.)
Made by Kuraray, density: 0.940g / cm ^Three , MI = 0.
7) is blended at a weight ratio of 90:10,
The heat-sealed port portion of the medical container of the present invention
Was manufactured. 10 w / v /% amino acid from this port
Liquid (amiparen) 500ml, 118 ℃
And then left at room temperature for 24 hours after autoclaving for
Tests were performed to determine the eligibility of the manufactured bags. (Example 2) Five-layer five-layer water-cooled inflation film molding
The following multilayer film of the present invention was formed by a machine. First layer (thick
Resin composition of polypropylene (trade name:
Hypole, manufactured by Grand Polymer Co., Ltd., density 0.910
g / cm ^Three , MI = 6.0) and a styrenic polymer (d)
(Lastmer) (trade name: Hibler, manufactured by Kuraray Co., Ltd.)
Degree: 0.940 g / cm ^Three , MI = 0.7) by weight ratio
80:20. Resin composition of second layer (thickness 30μm)
Is a modified polyolefin (trade name: Admer, Mitsui Oil
Made by Chemical Industry Co., Ltd., density 0.890 g / cm ^Three , MI =
4.0). The resin composition of the third layer (thickness 30 μm)
Is EVOH (trade name: Soarnol, Nippon Synthetic Chemical Industry)
Co., Ltd., ethylene copolymer molar ratio 44%). 4th layer
(Thickness 30μm) resin composition is nylon (trade name:
Bamido, manufactured by Mitsubishi Chemical Corporation, density 1.157 g / c
m ^Three ). The resin composition of the fifth layer (50 μm thickness)
Polyethylene (trade name: Ultex, Mitsui Petrochemical
Industrial Co., Ltd., density 0.940g / cm ^Three , MI = 6) and
did. The temperature setting of the extruder is 170 ℃ ~ 250 ℃, gold
The mold temperature is 180 ° C to 265 ° C, and the film take-off speed is
Molding was performed at a folding diameter of 300 mm at a rate of 10 to 12 m / min. this
Using an inflation film, seal width 10mm
The outer dimensions are 200 mm in the horizontal direction and 250 in the vertical direction.
mm bags (bags) were prepared. And the poly in the opening
Propylene (trade names: Hypol, Grand Polymer)
Produced by 0.910 g / cm ^Three , MI = 4)
Len polymer (elastomer) (Product name: Hibra
-, Manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI
= 0.7) was blended at a weight ratio of 90:10,
The injection molded port is heat-welded to
Container was manufactured. 10 w / v /% A from this port
Fill 500 ml of amino acid solution (amipalene),
・ Leave at room temperature for 24 hours after autoclaving for 40 minutes.
The following experiment was performed to determine the eligibility of the manufactured bags. (Example 3) Molding of 5 types of 5 layers water cooled inflation film
The following multilayer film of the present invention was formed by a machine. First layer (thick
Resin composition of polyethylene (trade name: c)
Lutzex, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.94
0 g / cm ^Three , MI = 4) and a styrenic polymer (elastomer
Stormer) (trade name: Hibler, manufactured by Kuraray Co., Ltd.)
Degree: 0.940 g / cm ^Three , MI = 0.7) by weight ratio
95: 5. Resin composition of second layer (thickness 30μm)
Is a modified polyolefin (trade name: Admer, Mitsui Oil
Chemical Industry Co., Ltd., density 0.930g / cm ^Three , MI =
2). The resin composition of the third layer (thickness 30 μm) is E
VOH (trade name: Soarnol, Nippon Synthetic Chemical Industry Co., Ltd.)
, Ethylene copolymer molar ratio 44%). 4th layer
(30μm thick) resin composition is modified polyolefin
(Product name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.890 g / cm ^Three , MI = 5.7). Fifth floor
(Thickness 30μm) resin composition is polypropylene (product
Name: Hypol, Grand Polymer Co., Ltd., density 0.9
10g / cm ^Three , MI = 4). Extruder temperature
The setting is 170 ° C to 220 ° C, the mold temperature is 180 ° C to 23
0 ° C, film take-off speed 9-12m / min, folding diameter
It was molded at 300 mm. This blown film
, Using the outside dimensions to make the seal width 10 mm
200mm length and 250mm length bag
Was. Then, polyethylene (trade name: Ult)
ZEX, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.945 g
/ Cm ^Three , MI = 10) and a styrenic polymer (Eras
Tomer) (trade name: Hibler, manufactured by Kuraray Co., Ltd., density:
0.940 g / cm ^Three , MI = 0.7) by weight ratio of 9
5: 5 blended and injection molded ports
The parts were heat-welded to produce the medical container of the present invention. This port
10 w / v /% amino acid solution (amipalen)
Fill 500ml and sterilize by autoclaving at 118 ℃ for 40 minutes
It was left at room temperature for 24 hours and subjected to the following experiment to produce
The eligibility of the bag was determined. (Example 4) Five-layer five-layer water-cooled inflation film molding
The following multilayer film of the present invention was formed by a machine. First layer (thick
Resin composition of polypropylene (trade name:
Hypole, manufactured by Grand Polymer Co., Ltd., density 0.910
g / cm ^Three , MI = 4) and polybutene-based polymer (commodity
Name: Buron, manufactured by Mitsui Petrochemical Industries, Ltd., Density: 0.
890 g / cm ^Three , MI = 0.2) and styrenic poly
Mer (elastomer) (trade name: Hibler, Inc.
Made by Le, density: 0.940g / cm ^Three , MI = 0.7)
The weight ratio was 90: 5: 5. Second layer (thickness 30μm)
Resin composition is modified polyolefin (trade name: ADMA
-, Manufactured by Mitsui Petrochemical Industry Co., Ltd., density 0.900 g / cm
^Three , MI = 4.0). Of the third layer (20 μm thick)
The resin composition is EVOH (trade name: EVAL, Kuraray Co., Ltd.)
, Ethylene copolymer molar ratio 44%). 4th layer
(30μm thick) resin composition is modified polyolefin
(Product name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.900 g / cm ^Three , MI = 4.0). Fifth floor
(Thickness 30μm) resin composition is polypropylene (product
Name: Hypol, Grand Polymer Co., Ltd., density 0.9
10g / cm ^Three , MI = 6). Extruder temperature
The setting is 170 ° C to 220 ° C, the mold temperature is 180 ° C to 23
0 ° C, film take-off speed 10-12m / min, folding
It was molded with a diameter of 520 mm. This inflation fill
Using a system, set the outer width so that the seal width is 10 mm.
Making a bag (bag) of 200 mm in the direction and 250 mm in the vertical direction
did. Then, in the opening, polypropylene (trade name: C
Ipol, manufactured by Grand Polymer Co., Ltd., density 0.910 g
/ Cm ^Three , MI = 6) and styrene-based polymer (Elasto
Ma) (Product name: Hibler, manufactured by Kuraray Co., Ltd., Density:
0.940 g / cm ^Three , MI = 0.7) by weight ratio of 9
Po: blended at 0:10 and injection molded
The medical container of the present invention was manufactured by heat-sealing the metal parts. this
10 w / v /% amino acid solution (amipalen) from port
And sterilized by high pressure steam at 118 ° C for 40 minutes.
After leaving at room temperature for 24 hours,
The eligibility of the bag was determined. (Example 5) Five-layer five-layer water-cooled inflation film molding
The following multilayer film of the present invention was formed by a machine. First layer (thick
Resin composition of polyethylene (trade name: c)
Lutzex, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.94
0 g / cm ^Three , MI = 4) and a styrenic polymer (elastomer
Stormer) (trade name: Hibler, manufactured by Kuraray Co., Ltd.)
Degree: 0.940 g / cm ^Three , MI = 0.7) and ethylene
Alpha olefin copolymer (trade name: Tuffmer, Mitsui Petrochemical)
Manufactured by Gaku Kogyo Co., Ltd., density: 0.880 g / cm ^Three , MI =
4.0) and 85: 5: 10 by weight. Second layer
(Thickness 30μm) resin composition is modified polyolefin
(Product name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.930 g / cm ^Three , MI = 4.0). Third layer
(Thickness 30 μm) resin composition is EVOH (trade name:
Burr, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio 44
%). The resin composition of the fourth layer (thickness: 30 μm)
Iron (trade name: Novamid Mid, Mitsubishi Kasei Co., Ltd., Density
1.152). Fifth layer (50μm thick) resin structure
The product is polyethylene (trade name: Ultzex, Mitsui Ishi)
Oil Chemical Industry Co., Ltd., density 0.940g / cm ^Three , MI =
3). Extruder temperature setting is 150 ℃ ~ 250
℃, mold temperature 170 ℃ ～ 265 ℃, film take-off
Molding speed is 11-13m / min, folding diameter 300mm
Was. Using this blown film, seal width
Outer dimensions 200mm in horizontal direction, vertical direction to be 10mm
A 250 mm bag was prepared. And the opening
Minute polyethylene (trade name: ULTZEX, Mitsui Oil)
Chemical Industry Co., Ltd., density 0.910g / cm ^Three , MI =
6) and styrene-based polymer (elastomer) (trade name:
High blur, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm
^Three , MI = 0.7) at a weight ratio of 90:10
And heat-welding the injection molded port
The medical container of the invention was manufactured. 10w from this port
500ml of v / v /% amino acid solution (amipalen)
And sterilize by autoclaving at 118 ° C for 40 minutes and then at room temperature for 24 hours.
Leave it for the following experiment and qualify the bag
Was determined. (Example 6) Five-layer, five-layer air-cooled inflation film molding
The following multilayer film of the present invention was formed by a machine. First layer (thick
Resin composition of polyethylene (trade name: c)
Lutzex, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.94
0 g / cm ^Three , MI = 4) and a styrenic polymer (elastomer
Stormer) (trade name: Hibler, manufactured by Kuraray Co., Ltd.)
Degree: 0.940 g / cm ^Three , MI = 0.7)
Ren α-olefin copolymer (trade names: Tuffmer, Mitsui Ishi)
Oil Chemical Industry Co., Ltd., density: 0.880 g / cm ^Three , MI
= 4.0) in a weight ratio of 85: 5: 10. Second layer
(Thickness 30μm) resin composition is modified polyolefin
(Product name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.940 g / cm ^Three , MI = 3.0). Third layer
(Thickness 30 μm) resin composition is EVOH (trade name: SO
Anol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer
44%). 4th layer (thickness 30μm) resin
Is a modified polyolefin (trade name: Admer, Mitsui Oil
Chemical Industry Co., Ltd., density 0.940g / cm ^Three , MI =
3.0). Fifth layer (thickness 30μm) resin composition
Is a polyethylene (trade name: Ultex, Mitsui Oil
Chemical Industry Co., Ltd., density 0.940g / cm ^Three , MI =
2). Extruder temperature setting is 150 ℃ ~ 220
℃, mold temperature 160 ℃ ～ 240 ℃, film take-off
Molding was performed at a speed of 8 to 11 m / min and a folding diameter of 300 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. And in the opening
Polyethylene (trade name: Ultex, Mitsui Petrochemical
Industrial Co., Ltd., density 0.945g / cm ^Three , MI = 8) and
Styrene-based polymer (elastomer) (Product name: Hive
Ra, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , M
I = 0.7) at a weight ratio of 90:10.
The port formed by injection molding is heat-welded to the medical device of the present invention.
A medical container was manufactured. 10 w / v /% from this port
500 ml of amino acid solution (amipalen) is filled, and 118
After leaving it at room temperature for 24 hours after autoclaving at 40 ° C for 40 minutes,
The following tests were performed to determine the eligibility of the manufactured bags.
Was. (Example 7) Three types of three-layer air-cooled inflation film molding
The following multilayer film of the present invention was formed by a machine. First layer (thick
Resin composition of polypropylene (trade name:
Hypole, manufactured by Grand Polymer Co., Ltd., density 0.910
g / cm ^Three , MI = 4) and a styrenic polymer (Eras
Tomer) (trade name: Hibler, manufactured by Kuraray Co., Ltd., density:
0.940 g / cm ^Three , MI = 0.7) by weight ratio of 8
0:20. Resin composition of second layer (thickness 30μm)
Is a modified polyolefin (trade name: Admer, Mitsui Oil
Made by Chemical Industry Co., Ltd., density 0.890 g / cm ^Three , MI =
5.7). The resin composition of the third layer (thickness 30 μm)
Is EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd.)
(Lens copolymer molar ratio: 44%). Extruder temperature
The setting is 170 ° C to 220 ° C, the mold temperature is 180 ° C to 23
0 ° C, film take-off speed 8-14m / min, folding diameter
It was molded at 320 mm. This blown film
, Using the outside dimensions to make the seal width 10 mm
110mm in length and 130mm in length
Was. Then, open the polypropylene (Product name: High
Paul, manufactured by Grand Polymer Co., Ltd., density 0.910 g /
cm ^Three , MI = 6) and a styrenic polymer (elastomer)
ー) (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.
940 g / cm ^Three , MI = 0.7) in a weight ratio of 90: 1.
0 and blend the injection molded port
Heat welding was performed to produce the medical container of the present invention. This port
10 w / v /% amino acid solution (amipalene)
0 ml, and subjected to the following experiment.
Judged personality. (Example 8) Three types of three-layer air-cooled inflation film molding
The following multilayer film of the present invention was formed by a machine. First layer (thick
Resin composition of polyethylene (trade name: c)
Lutzex, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.93
0 g / cm ^Three , MI = 3.0) and styrenic polymer
(Elastomer) (Product name: Hibler, Kuraray Co., Ltd.)
Made, density: 0.940 g / cm ^Three , MI = 0.7)
The amount ratio was 90:10. Tree of the second layer (thickness 30μm)
The fat composition is modified polyolefin (trade names: Admer,
Manufactured by Well Petrochemical Co., Ltd., density 0.890 g / cm ^Three , M
I = 4.0). Third layer (thickness 30μm) resin structure
The product is EVOH (trade name: Soarnol, Nippon Synthetic Chemical Industry Co., Ltd.)
Co., Ltd., ethylene copolymer molar ratio 44%). Push
The temperature setting of the unloading machine is 170 ° C to 210 ° C, and the mold temperature is 1
80 ° C to 220 ° C, film take-off speed is 10 to 12
m / min, and formed with a folding diameter of 320 mm. This inflation
Using a sealing film so that the seal width is 10 mm
The outer dimensions of the bag are 110mm in width and 130mm in length
(Bag) was prepared. And polyethylene in the opening
(Product name: ULTZEX, manufactured by Mitsui Petrochemical Industries, Ltd.,
Density 0.945g / cm ^Three , MI = 6) and styrene-based
Rimmer (elastomer) (trade name: Hibler, Co., Ltd.)
Made by Rare, density: 0.940g / cm ^Three , MI = 0.7)
Is blended at a weight ratio of 90:10, and injected.
The molded port is heat-sealed to produce the medical container of the present invention.
Built. 10 w / v /% amino acid solution from this port
(Amipalene) was filled in 100 ml and used for the following experiment.
The suitability of the manufactured bags was determined. (Example 9) Three-layer, three-layer air-cooled inflation film molding
The following multilayer film of the present invention was formed by a machine. First layer (thick
Resin composition of polypropylene (trade name:
Hypole, manufactured by Grand Polymer Co., Ltd., density 0.910
g / cm ^Three , MI = 4) and polybutene-based polymer (commodity
Name: Buron, manufactured by Mitsui Petrochemical Industries, Ltd., Density: 0.
890 g / cm ^Three , MI = 0.2) and styrenic poly
Mer (elastomer) (trade name: Hibler, Inc.
Made by Le, density: 0.940g / cm ^Three , MI = 0.7)
The weight ratio was 70:10:20. Second layer (thickness 30μ)
m) is composed of a modified polyolefin (trade name: Ad
Ma, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.930 g / c
m ^Three , MI = 2). Tree of the third layer (thickness 30μm)
The fat composition is EVOH (trade name: Soarnol, Nippon Gohsei)
Gaku Kogyo Co., Ltd., ethylene copolymer molar ratio 44%)
Was. Extruder temperature setting is 170 ° C ~ 220 ° C, mold
Temperature is 180-230 ° C, film take-off speed is 9
Molding was performed at a folding diameter of 320 mm at １２12 m / min. This Inn
Using a blown film, seal width is 10 mm.
As shown, the outer dimensions are 110mm horizontally and 130mm vertically
Was prepared. And the opening part
Pyrene (trade name: Hypol, Grand Polymer Co., Ltd.)
Made, density 0.910g / cm ^Three , MI = 6) and styrene
Polymer (elastomer) (trade name: Hibler,
Made by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI =
0.7) at a weight ratio of 90:10.
The heat-sealed port of the injection molded port
A container was manufactured. 10 w / v /% net from this port
The following experiment was performed by filling 100 ml of acid solution (amipalen).
To determine the eligibility of the manufactured bags. (Example 10) Formation of three types of three-layer air-cooled inflation films
The following multilayer film of the present invention was formed on a mold machine. First layer
(Thickness 50μm) resin composition is polyethylene (commodity
Name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.940 g / cm ^Three , MI = 4) and ethylene α-olef
Thinner copolymer (trade name: Tuffmer, Mitsui Petrochemical Industries, Ltd.)
Co., Ltd., density: 0.880 g / cm ^Three , MI = 4.0)
And styrene-based polymer (elastomer) (trade name:
High blur, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm
^Three , MI = 0.7) in a weight ratio of 90: 5: 5. No.
The resin composition of the two layers (thickness 30μm) is modified polyolefin
(Trade name: Admar, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.900 g / cm ^Three , MI = 4.0). Third layer
(Thickness: 20 μm) resin composition is EVOH (trade name:
Burr, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio 44
%). Extruder temperature setting is 170 ° C ~ 220
℃, mold temperature 180 ℃ ～ 230 ℃, film take-off
Molding speed is 10-12m / min, folding diameter is 320mm
Was. Using this blown film, seal width
110mm in horizontal dimension and 10mm in vertical dimension so as to be 10mm
A 130 mm bag was prepared. And the opening
Minute polyethylene (trade name: ULTZEX, Mitsui Oil)
Chemical Industry Co., Ltd., density 0.945g / cm ^Three , MI =
6) and styrene-based polymer (elastomer) (trade name:
High blur, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm
^Three , MI = 0.7) at a weight ratio of 90:10
And heat-welding the injection molded port
The medical container of the invention was manufactured. 10w from this port
100ml of v / v /% amino acid solution (amipalen)
Subject to the following experiment to determine the eligibility of the manufactured bag
did. (Example 11) Three-layer three-layer air-cooled inflation film formation
The following multilayer film of the present invention was formed on a mold machine. First layer
(Thickness 30μm) resin composition is polypropylene (product
Name: Hypol, Grand Polymer Co., Ltd., density 0.9
10g / cm ^Three , MI = 4) and a styrenic polymer (d)
(Lastmer) (trade name: Hibler, manufactured by Kuraray Co., Ltd.)
Degree: 0.940 g / cm ^Three , MI = 0.7) and ethylene
Alpha olefin copolymer (trade name: Tuffmer, Mitsui Petrochemical)
Manufactured by Gaku Kogyo Co., Ltd., density: 0.880 g / cm ^Three , MI =
4.0) and 85: 10: 5 by weight. Second layer
(Thickness 30μm) resin composition is modified polyolefin
(Product name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.930 g / cm ^Three , MI = 4.0). Third layer
(Thickness 30 μm) resin composition is EVOH (trade name:
Burr, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio 44
%). Extruder temperature setting is 150 ℃ ~ 250
℃, mold temperature 170 ℃ ～ 265 ℃, film take-off
The speed is 11-13m / min, and the fold diameter is 320mm.
Was. Using this blown film, seal width
110mm in horizontal dimension and 10mm in vertical dimension so as to be 10mm
A 130 mm bag was prepared. And the opening
Minute Polypropylene (Product Name: Hypole, Grand Po
Made by Rimmer Co., Ltd., density 0.910g / cm ^Three , MI = 6)
And styrene-based polymer (elastomer) (Product name: High
Blur, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three ,
MI = 0.7) at a weight ratio of 90:10.
The injection molded port is heat-welded to
A medical container was manufactured. 10 w / v / from this port
100% amino acid solution (amiparen)
And the eligibility of the manufactured bags was determined. (Example 12) Five types of five-layer water-cooled inflation films
The following multilayer film of the present invention was formed on a mold machine. Innermost layer
(Thickness 50μm) resin composition is polypropylene (product
Name: Hypol, Grand Polymer Co., Ltd., density 0.9
10g / cm ^Three , MI = 4) and ethylene α-olefin
Polymer (trade name: Toughmer, manufactured by Mitsui Petrochemical Industries, Ltd.)
Density: 0.880 g / cm ^Three , MI = 4.0)
Len polymer (elastomer) (Product name: Hibra
-, Manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI
= 0.7) in a weight ratio of 75:10:15. Inner neighbor
The resin composition of the layer (thickness: 30 μm) is a modified polyolefin
(Product name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.890 g / cm ^Three , MI = 5.7). Middle class
(Thickness 30 μm) resin composition is EVOH (trade name:
Burr, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio 44
%). The resin composition of the outer adjacent layer (thickness 30 μm)
Nylon (trade name: Novamid Mid, Mitsubishi Kasei Co., Ltd., density
1.152). Resin structure of outermost layer (thickness 50μm)
The product is polyethylene (trade name: Ultzex, Mitsui Ishi)
Oil Chemical Industry Co., Ltd., density 0.945g / cm ^Three , MI =
8) and ethylene α-olefin copolymer (trade name: TAFMA
-, Manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.880 g / c
m ^Three , MI = 4.0) in a weight ratio of 80:20. Push
The temperature setting of the dispenser is 160 ° C ~ 250 ° C, the mold temperature is
180 ° C to 260 ° C, film take-off speed is 12 to 1
Molding was performed at 4 m / min and a folding diameter of 300 mm. This inflation
Using an optional film, the seal width will be 10 mm
As shown, a bag with outer dimensions of 200 mm horizontally and 250 mm vertically
(Bag) was prepared. Then, in the opening, polypropylene
(Product name: Hypol, manufactured by Grand Polymer Co., Ltd.
Degree 0.910g / cm ^Three , MI = 6) and styrenic poly
Mer (elastomer) (trade name: Hibler, Inc.
Made by Le, density: 0.940g / cm ^Three , MI = 0.7)
Blend at 90:10 by weight and injection
Heat welding the molded port to produce the medical container of the present invention
did. A 10 w / v /% amino acid solution (A
Mipalen) and fill it with 500ml
After 24 hours at room temperature after autoclaving, use for the following experiments.
The suitability of the manufactured bags was determined. (Example 13) Five-layer, five-layer water-cooled inflation film formation
The following multilayer film of the present invention was formed on a mold machine. Innermost layer
(Thickness 50μm) resin composition is polypropylene (product
Name: Hypol, Grand Polymer Co., Ltd., density 0.9
10g / cm ^Three , MI = 6.0) and a polybutene-based polymer
-(Trade name: Buron, manufactured by Mitsui Petrochemical Industries, Ltd.
Degree: 0.890 g / cm ^Three , MI = 0.2) and styrene
Polymer (elastomer) (trade name: Hibler,
Made by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI =
0.7) was 75: 5: 20 by weight. Inner adjacent layer
(Thickness 30μm) resin composition is modified polyolefin
(Product name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.890 g / cm ^Three , MI = 5.7). Middle class
(Thickness 30 μm) resin composition is EVOH (trade name: SO
Anol, Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer mole
44%). Outer adjacent layer (thickness 30μm) resin
The composition is modified polyolefin (trade names: Admer, Mitsui
Petrochemical Co., Ltd., density 0.890g / cm ^Three , MI
= 5.7). Outermost layer (40μm thick) resin composition
Is a polypropylene (trade name: Hypole, Grand Po
Made by Rimmer Co., Ltd., density 0.910g / cm ^Three , MI = 4)
And propylene α-olefin copolymer (trade name: TAFMA
-, Manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.870 g / c
m ^Three , MI = 4.0) in a weight ratio of 95: 5. Push
The temperature setting of the unloader is 170 ° C to 240 ° C, and the mold temperature is 1
80 ° C to 250 ° C, film take-up speed is 8 to 12m
/ Min, with a folding diameter of 300 mm. This inflation
Using a seal film so that the seal width is 10 mm.
The outer dimensions of the bag are 200mm horizontally and 250mm vertically
(Bag) was prepared. Then, in the opening, polypropylene
(Product name: Hypol, manufactured by Grand Polymer Co., Ltd.
Degree 0.910g / cm ^Three , MI = 4) and styrenic poly
Mer (elastomer) (trade name: Hibler, Inc.
Made by Le, density: 0.940g / cm ^Three , MI = 0.7)
Blend at 90:10 by weight and injection
Heat welding the molded port to produce the medical container of the present invention
did. A 10 w / v /% amino acid solution (A
Mipalen) and fill it with 500ml
After 24 hours at room temperature after autoclaving, use for the following experiments.
The suitability of the manufactured bags was determined. (Example 14) Five-layer, five-layer water-cooled inflation film formation
The following multilayer film of the present invention was formed on a mold machine. Innermost layer
(Thickness 50μm) resin composition is polyethylene (commodity
Name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.940 g / cm ^Three , MI = 4) and polybutene-based poly
Marker (trade name: Buron, manufactured by Mitsui Petrochemical Industries, Ltd.)
Density: 0.890 g / cm ^Three , MI = 0.2) and ste
Len polymer (elastomer) (Product name: Hibra
-, Manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI
= 0.7) in a weight ratio of 90: 5: 5. Inner adjacent layer
(Thickness 30μm) resin composition is modified polyolefin
(Product name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.930 g / cm ^Three , MI = 4). Middle layer (thick
Resin composition of 30 μm) is EVOH (trade name: Soano
Manufactured by Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer molar ratio
Rate of 44%). Resin structure of outer adjacent layer (thickness 30μm)
Nari is a modified polyolefin (trade name: Admer, Mitsui Ishi)
Oil Chemical Industry Co., Ltd., density 0.930g / cm ^Three , MI =
4). The resin composition of the outermost layer (50 μm thick)
Polyethylene (trade name: ULTZEX, Mitsui Petrochemical Co., Ltd.)
Industry Co., Ltd., density 0.940g / cm ^Three , MI = 4) and
Tylene polymer (elastomer) (Product name: Hibra
-, Manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI
= 0.7) in a weight ratio of 95: 5. Extruder temperature
Degree setting is 150 ° C to 220 ° C, mold temperature is 170 ° C to 2
30 ° C, film take-off speed 9-13m / min, folding
It was molded with a diameter of 300 mm. This inflation fill
Using a system, set the outer width so that the seal width is 10 mm.
Making a bag (bag) of 200 mm in the direction and 250 mm in the vertical direction
did. Then, polyethylene (trade name: ur)
Tozex, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.945
g / cm ^Three , MI = 10) and a styrenic polymer (elastomer)
Stormer) (trade name: Hibler, manufactured by Kuraray Co., Ltd.)
Degree: 0.940 g / cm ^Three , MI = 0.7) by weight ratio
95: 5 blended and injection molded po
The medical container of the present invention was manufactured by heat-sealing the metal parts. this
10 w / v /% amino acid solution (amipalen) from port
And sterilized by high pressure steam at 118 ° C for 40 minutes.
After leaving at room temperature for 24 hours,
The eligibility of the bag was determined. (Example 15) Five-layer five-layer water-cooled inflation film formation
The following multilayer film of the present invention was formed on a mold machine. Innermost layer
(Thickness 50μm) resin composition is polypropylene (product
Name: Hypol, Grand Polymer Co., Ltd., density 0.9
10g / cm ^Three , MI = 4) and polyethylene (trade name:
Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.9
40g / cm ^Three , MI = 4) and styrenic polymer
(Elastomer) (Product name: Hibler, Kuraray Co., Ltd.)
Made, density: 0.940 g / cm ^Three , MI = 0.7)
The amount ratio was 55:35:10. Inner adjacent layer (thickness 30μ)
m) is composed of a modified polyolefin (trade name: Ad
Ma, manufactured by Mitsui Petrochemical Industry Co., Ltd., density 0.890 g / c
m ^Three , MI = 4.0). Intermediate layer (thickness 20μm)
Resin composition is EVOH (trade name: EVAL, Inc.
, Ethylene copolymer molar ratio 44%). Outside
The resin composition of the layer (thickness: 30 μm) is made of nylon (trade name:
Novamid, manufactured by Mitsubishi Kasei Corporation, density 1.157 g / cm
^Three ). The resin composition of the outermost layer (thickness 30 μm)
Repropylene (trade names: Hypol, Grand Polymer)
Produced by 0.910 g / cm ^Three , MI = 6) and PO
Libutene-based polymer (trade name: Buron, Mitsui Petrochemical)
Manufactured by Gaku Kogyo Co., Ltd., density: 0.890 g / cm ^Three , MI =
0.2) was 90:10 by weight. Extruder temperature
Degree setting is 150 ° C to 240 ° C, mold temperature is 160 ° C to 2
50 ° C, film take-off speed is 10 to 13 m / min, folding
It was molded with a diameter of 520 mm. This inflation
Using lum, make the seal width 10mm
Create 200mm horizontal and 250mm vertical bags
Made. Then, in the opening, polypropylene (trade name:
Hypole, manufactured by Grand Polymer Co., Ltd., density 0.910
g / cm ^Three , MI = 6) and a styrenic polymer (Eras
Tomer) (trade name: Hibler, manufactured by Kuraray Co., Ltd., density:
0.940 g / cm ^Three , MI = 0.7) by weight ratio of 8
Po: blended at 0:20 and injection molded
The medical container of the present invention was manufactured by heat-sealing the metal parts. this
10 w / v /% amino acid solution (amipalen) from port
And sterilized by high pressure steam at 118 ° C for 40 minutes.
After leaving at room temperature for 24 hours,
The eligibility of the bag was determined. (Example 16) Three-layer three-layer air-cooled inflation film formation
The following multilayer film of the present invention was formed on a mold machine. Innermost layer
(Thickness 50μm) resin composition is polypropylene (product
Name: Hypol, Grand Polymer Co., Ltd., density 0.9
10g / cm ^Three , MI = 4) and ethylene α-olefin
Polymer (trade name: Toughmer, manufactured by Mitsui Petrochemical Industries, Ltd.)
Density: 0.880 g / cm ^Three , MI = 4.0)
Len polymer (elastomer) (Product name: Hibra
-, Manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI
= 0.7) in a weight ratio of 75:10:15. Inner neighbor
The resin composition of the layer (thickness: 30 μm) is a modified polyolefin
(Product name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.890 g / cm ^Three , MI = 5.7). Outermost layer
(Thickness 30 μm) resin composition is EVOH (trade name:
Burr, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio 44
%). Extruder temperature setting is 170 ° C ~ 220
℃, mold temperature 180 ℃ ～ 230 ℃, film take-off
The speed is 11-14m / min and the fold diameter is 320mm.
Was. Using this blown film, seal width
110mm in horizontal dimension and 10mm in vertical dimension so as to be 10mm
A 130 mm bag was prepared. And the opening
Minute Polypropylene (Product Name: Hypole, Grand Po
Made by Rimmer Co., Ltd., density 0.910g / cm ^Three , MI = 6)
And styrene-based polymer (elastomer) (Product name: High
Blur, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three ,
MI = 0.7) at a weight ratio of 90:10.
The injection molded port is heat-welded to
A medical container was manufactured. 10 w / v / from this port
100% amino acid solution (amiparen)
And the eligibility of the manufactured bags was determined. (Example 17) Three-layer, three-layer air-cooled inflation film formation
The following multilayer film of the present invention was formed on a mold machine. Innermost layer
(Thickness 50μm) resin composition is polypropylene (product
Name: Hypol, Grand Polymer Co., Ltd., density 0.9
10g / cm ^Three , MI = 4) and polybutene-based polymer
(Product name: Buron, manufactured by Mitsui Petrochemical Industry Co., Ltd.
Degree: 0.890 g / cm ^Three , MI = 0.2) and Echile
Α-olefin copolymer (trade name: Tuffmer, Mitsui Sekiyu)
Chemical Industry Co., Ltd., density: 0.880 g / cm ^Three , MI =
4.0) and styrenic polymer (elastomer)
(Product name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.94
0 g / cm ^Three , MI = 0.7) in a weight ratio of 70:10:
10:10. Intermediate layer (inner adjacent layer: thickness 30 μm)
Resin composition is modified polyolefin (trade name: ADMA
ー, manufactured by Mitsui Petrochemical Industry Co., Ltd., density 0.890 g / cm
^Three , MI = 4.0). Of the outermost layer (thickness 30μm)
The resin composition is EVOH (trade name: Soarnol, Nihon Gosei
Chemical Industry Co., Ltd., ethylene copolymer molar ratio 44%)
Was. Extruder temperature setting is 170 ℃ ~ 210 ℃, mold
Temperature is 180-230 ° C, film take-off speed is 9
It was molded at a folding diameter of 320 mm at １３13 m / min. This Inn
Using a blown film, seal width is 10 mm.
As shown, the outer dimensions are 110mm horizontally and 130mm vertically
Was prepared. And the opening part
Pyrene (trade name: Hypol, Grand Polymer Co., Ltd.)
Made, density 0.910g / cm ^Three , MI = 4) and styrene
Polymer (elastomer) (trade name: Hibler,
Made by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI =
0.7) at a weight ratio of 90:10.
The heat-sealed port of the injection molded port
A container was manufactured. 10 w / v /% net from this port
The following experiment was performed by filling 100 ml of acid solution (amipalen).
To determine the eligibility of the manufactured bags. (Example 18) Three-layer three-layer air-cooled inflation film formation
The following multilayer film of the present invention was formed on a mold machine. Innermost layer
(Thickness 50μm) resin composition is polyethylene (commodity
Name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.940 g / cm ^Three , MI = 4) and ethylene α-olef
Thinner copolymer (trade name: Tuffmer, Mitsui Petrochemical Industries, Ltd.)
Co., Ltd., density: 0.880 g / cm ^Three , MI = 4.0)
And polybutene-based polymers (trade names: Buron, Mitsui Ishi)
Yuka Chemical Industry Co., Ltd., density: 0.890 g / cm ^Three , MI
= 0.2) and styrene-based polymer (elastomer)
(Product name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.94
0 g / cm ^Three , MI = 0.7) in a weight ratio of 80:10:
5: 5. Tree of middle layer (adjacent layer: thickness 30μm)
The fat composition is modified polyolefin (trade names: Admer,
Made by Well Petrochemical Co., Ltd., density 0.930g / cm ^Three , M
I = 2). Resin composition of outermost layer (thickness 30μm)
Is EVOH (trade name: Soarnol, Nippon Synthetic Chemical Industry)
Co., Ltd., ethylene copolymer molar ratio: 44%). Push
The temperature setting of the unloader is 170 ° C to 220 ° C, and the mold temperature is 1
80-230 ° C, film take-up speed 9-12m
/ Min, with a folding diameter of 320 mm. This inflation
Using a seal film so that the seal width is 10 mm.
The outer dimensions of the bag are 110mm in width and 130mm in length
(Bag) was prepared. Then, in the opening, polypropylene
(Product name: Hypol, manufactured by Grand Polymer Co., Ltd.
Degree 0.910g / cm ^Three , MI = 6) and styrenic poly
Mer (elastomer) (trade name: Hibler, Inc.
Made by Le, density: 0.940g / cm ^Three , MI = 0.7)
Blend at 90:10 by weight and injection
Heat welding the molded port to produce the medical container of the present invention
did. A 10 w / v /% amino acid solution (A
Mipalen) was filled in 100 ml and subjected to the following experiment.
The eligibility of the constructed bags was determined. (Comparative Example 1) Five types of five-layer air-cooled inflation film molding
The following films were formed on the machine. First layer (thickness 50μ)
m) is made of polypropylene (trade name: HiPo
Manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm
^Three , MI = 4) 0:20. Second layer (thickness 30μ)
m) is composed of a modified polyolefin (trade name: Ad
Ma, manufactured by Mitsui Petrochemical Industry Co., Ltd., density 0.890 g / c
m ^Three , MI = 5.7). Third layer (thickness 30μm)
Resin composition is EVOH (trade name: EVAL, Inc.
, Ethylene copolymer molar ratio 44%). 4th layer
(30μm thick) resin composition is modified polyolefin
(Product name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.890 g / cm ^Three , MI = 5.7). Fifth floor
(Thickness 50μm) resin composition is polypropylene (product
Name: Hypol, Grand Polymer Co., Ltd., density 0.9
10g / cm ^Three , MI = 6). Extruder temperature
The setting is 170 ° C to 220 ° C, the mold temperature is 180 ° C to 23
0 ° C, film take-off speed 10-13m / min, folding
It was molded with a diameter of 300 mm. This inflation fill
Using a system, set the outer width so that the seal width is 10 mm.
Making a bag (bag) of 200 mm in the direction and 250 mm in the vertical direction
did. Then, in the opening, polypropylene (trade name: C
Ipol, manufactured by Grand Polymer Co., Ltd., density 0.910 g
/ Cm ^Three , MI = 6) by injection molding
The parts were heat-welded. 10 w / v /% A from this port
Fill 500 ml of amino acid solution (amipalene),
・ Leave at room temperature for 24 hours after autoclaving for 40 minutes.
The following experiment was performed to determine the eligibility of the manufactured bags. (Comparative Example 2) Five-layer, five-layer air-cooled inflation film molding
The following films were formed on the machine. First layer (thickness 40μ)
m) is made of polyethylene (trade name:
Box, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.930 g / c
m ^Three , MI = 2). Tree of the second layer (thickness 30μm)
The fat composition is modified polyolefin (trade names: Admer,
Made by Well Petrochemical Industry Co., Ltd., density 0.940g / cm ^Three , M
I = 3.0). Third layer (thickness 30μm) resin structure
The product is EVOH (trade name: Soarnol, Nippon Synthetic Chemical Industry Co., Ltd.)
(Made by Sangyo Co., Ltd., ethylene copolymer molar ratio: 44%). No.
Four layers of resin (thickness 30μm) are modified polyolefin
(Product name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.940 g / cm ^Three , MI = 3.0). Fifth floor
(Thickness 30μm) resin composition is polyethylene (commodity
Name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density
0.930 g / cm ^Three , MI = 2). Extruder
Temperature setting is 150-220 ° C, mold temperature is 160 ° C
~ 240 ° C, film take-off speed is 8 ~ 11m / min,
It was molded with a folding diameter of 300 mm. This inflation
Using a film, set the outer dimensions so that the seal width is 10 mm.
200mm horizontal and 250mm vertical bags
Produced. Then, polyethylene (trade name:
Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.9
45g / cm ^Three , MI = 8) Injection molded
The port was heat welded. 10 w / v / from this port
% Amino acid solution (amipalene)
After autoclaving at 8 ° C for 40 minutes, leave at room temperature for 24 hours.
To determine the eligibility of the manufactured bag
did. (Comparative Example 3) Three-layer, three-layer air-cooled inflation film molding
The following films were formed on the machine. First layer (thickness 50μ)
m) is made of polypropylene (trade name: HiPo
Manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm
^Three , MI = 4). Second layer (inner adjacent layer: thickness 30μ)
m) is composed of a modified polyolefin (trade name: Ad
Ma, manufactured by Mitsui Petrochemical Industry Co., Ltd., density 0.890 g / c
m ^Three , MI = 5.7). Third layer (thickness 30μm)
Resin composition is EVOH (trade name: EVAL, Inc.
, Ethylene copolymer molar ratio 44%). Extrusion
The temperature setting of the extruder is 170 to 220 ° C, and the mold temperature is 18
0 ° C to 230 ° C, film take-up speed is 8 to 14m /
It was molded with a folding diameter of 320 mm. This inflation
Using a film, seal width is 10 mm,
110 mm (width) x 130 mm (length) bag
) Was prepared. And the opening part is polypropylene
(Product name: Hypol, manufactured by Grand Polymer Co., Ltd., density
0.910 g / cm ^Three , MI = 6)
The molded port was heat welded. 1 from this port
100 ml of 0 w / v /% amino acid solution (amipalen)
And subjected to the following experiments to determine the eligibility of the manufactured bags.
Specified. (Comparative Example 4) Three-layer three-layer air-cooled inflation film molding
The following films were formed on the machine. First layer (thickness 50μ)
m) is made of polyethylene (trade name:
Box, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.930 g / c
m ^Three , MI = 3.0). Second layer (thickness 30μm)
Resin composition is modified polyolefin (trade name: ADMA
ー, manufactured by Mitsui Petrochemical Industry Co., Ltd., density 0.890 g / cm
^Three , MI = 4.0). Of the third layer (thickness 30μm)
The resin composition is EVOH (trade name: Soarnol, Nihon Gosei
Chemical Industry Co., Ltd., ethylene copolymer molar ratio 44%)
Was. Extruder temperature setting is 170 ℃ ~ 210 ℃, mold
Temperature is 180-220 ° C, film take-off speed is 1
Molding was performed at 0 to 12 m / min and a folding diameter of 320 mm. This
Using a blown film, seal width 10mm
The outer dimensions are 110 mm horizontally and 130 m vertically.
m was prepared. Then, in the opening
Cylene (trade name: ULTZEX, Mitsui Petrochemical Industry)
Co., Ltd., density 0.945g / cm ^Three , MI = 6)
The injection molded port was heat welded.
A 10 w / v /% amino acid solution (amipare
100 ml), and subjected to the following experiment to produce
The eligibility of the bag was determined. 1) Delamination test after sterilization (sterilization number: 50)

[0046]

[Table 1]

The delamination test was carried out in Example 1 having a five-layer structure.
Performed only for ~ 6. 2) Stability test results after single fall (n = 10) and single fall abuse (n = 5) Samples subjected to the test were placed in a low temperature constant temperature bath BNC-120 (set at 8 ° C.) manufactured by Tabai Espec Corporation. After storing for a period of time and confirming that the product temperature was 10 ° C. or less, it was subjected to a drop test. The drop test condition was to drop from a height of 60 cm above the floor. Examples 1 to 6 and Comparative Examples 1 and 2 were sterilized 2
The experiment was performed after 4 hours.

The single item drop test was evaluated by visually examining the following three points: (1) the presence or absence of scratches 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 inside. The inspection was confirmed.

The sample subjected to the single drop test was subjected to a constant temperature and humidity chamber (set at 40 ° C. and 75% RH) manufactured by Tabai Espec Co., Ltd.
After storage in R-4FT, the stability of the content drug (amino acid) was examined after three months. The content was determined by examining the individual content of the amino acid, and any one whose content was below the specified value was rejected.

[0050]

[Table 2]

*: After sterilization, one that does not show delamination is used. ∴ #: After sterilization, delamination was observed in all samples.

[0052]

[Table 3]

*: After sterilization, one that does not show delamination is used. ∴ #: After sterilization, delamination was observed in all samples.

Even if it seemed that there was no problem in appearance, in the control example, since a minute pinhole or the like was generated, a decrease in amino acid content was observed in all samples except one bag.

Next, Examples 19 to 26 and Comparative Example 5 of the outer bag made of the film of the present invention will be described. (Example 19) The following sealant film was formed by a three-type three-layer air-cooled inflation film molding machine. The resin composition of the innermost layer (thickness: 50 μm) consists of polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g / cm ³ , MI = 4) and styrene-based polymer (elastomer) (product) (Name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm3, MI = 0.7) was set to 90:10 by weight ratio. The resin composition of the inner adjacent layer (thickness 30 μm) is a modified polyolefin (trade name: Admer,
Mitsui Petrochemical Industries, Ltd., density 0.930 g / cm ³ ,
MI = 4). Outermost layer of sealant (thickness 30μm)
Resin composition was EVOH (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer molar ratio: 44%). The temperature of the extruder was set at 150 ° C. to 220 ° C., the mold temperature was 170 ° C. to 230 ° C., the film take-up speed was 9 to 13 m / min, and the film was formed with a folding diameter of 300 mm. The polyethylene terephthalate film (thickness: 12 μm, manufactured by Toyobo Co., Ltd.) was dry-laminated with the sealant film using a urethane-based adhesive (trade name: Takerac Takenate, manufactured by Takeda Pharmaceutical Co., Ltd.). Using this lamination film, the outer dimension is 220 mm in the lateral direction so that the seal width is 10 mm,
An outer bag (three-sided seal) of the present invention having a length of 300 mm was prepared. Then, a 150 mm (horizontal) and 200 mm (longitudinal) polyethylene bag previously filled with 10 mL of a 10 w / v /% amino acid solution (trade name: Amipalene, manufactured by Otsuka Pharmaceutical Factory Co., Ltd.) is placed in this outer bag, and the upper part is heat-sealed. ,
The following experiment was performed to determine the suitability of the manufactured outer bag. (Example 20) The following sealant film was formed by a three-type three-layer air-cooled inflation film molding machine. The resin composition of the innermost layer (thickness: 50 μm) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density: 0.9).
10 g / cm ³ , MI = 6.0) and a styrene-based polymer (elastomer) (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm 3, MI = 0.7) in a weight ratio of 90: It was set to 10. The resin composition of the inner adjacent layer (thickness 30 μm) is a modified polyolefin (trade name: Admer,
Mitsui Petrochemical Industries, Ltd., density 0.890 g / cm ³ ,
MI = 5.7). Outermost layer of sealant (thickness 30μ)
m) is made of EVOH (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer molar ratio: 44)
%). The temperature setting of the extruder is 170 ° C ~ 240
C., a mold temperature of 180 to 250.degree. C., a film take-up speed of 8 to 12 m / min, a folding diameter of 300 mm, and then cutting both ends. The polyethylene terephthalate film (thickness: 12 μm, manufactured by Toyobo Co., Ltd.) was dry-laminated with the sealant film using a urethane-based adhesive (trade name: Takerac Takenate, manufactured by Takeda Pharmaceutical Co., Ltd.). Using this lamination film, the outer dimension is 22 mm so that the seal width is 10 mm.
An outer bag (three-sided seal) of the present invention having a length of 0 mm and a length of 300 mm was prepared. A 10 w / v /% amino acid solution (trade name: Amipalene, manufactured by Otsuka Pharmaceutical Factory Co., Ltd.)
150mm horizontal, 200m vertical filled with 00mL
A polyethylene bag was placed in this outer bag, the upper part was heat-sealed, and subjected to the following experiment to determine the suitability of the manufactured outer bag. Example 21 The following sealant film was formed by a three-type three-layer air-cooled inflation film molding machine. The resin composition of the innermost layer (thickness: 50 μm) consists of polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g / cm ³ , MI = 4) and styrene-based polymer (elastomer) (product) (Name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm3, MI = 0.7) was set to 90:10 by weight ratio. The resin composition of the inner adjacent layer (thickness 10 μm) is a modified polyolefin (trade name: Admer,
Mitsui Petrochemical Industries, Ltd., density 0.930 g / cm ³ ,
MI = 4). Outermost layer of sealant (thickness 30μm)
The resin composition of EVOH (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer molar ratio: 44%) and styrene-based polymer (elastomer) (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm3, M
I = 0.7) in a weight ratio of 95: 5. Extruder temperature setting is 150 ° C ~ 220 ° C, mold temperature is 170 ° C ~
A film was formed at 230 ° C., a film take-up speed of 9 to 13 m / min, and a folding diameter of 300 mm, and then both ends were cut. An adhesive is applied to the sealant film with a urethane-based adhesive (trade name: Takerac Takenate, manufactured by Takeda Pharmaceutical Co., Ltd.) to form a polyethylene terephthalate film (thickness: 12 μm).
m, manufactured by Toyobo Co., Ltd.). Using this lamination film, the outer dimensions are 220 mm in the horizontal direction and 300 m in the vertical direction so that the seal width is 10 mm.
m of the outer bag (three-side seal) of the present invention was produced. And
A 10 w / v /% amino acid solution (trade name: Amipalene,
(Made by Otsuka Pharmaceutical Factory Co., Ltd.) A 150 mm horizontal and 200 mm vertical polyethylene bag filled with a liquid volume of 500 mL was placed in this outer bag, and the upper part was heat-sealed. Judged. (Example 22) The following sealant film was formed by a three-type three-layer air-cooled inflation film molding machine. The resin composition of the innermost layer (thickness: 50 μm) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density: 0.9).
10 g / cm ³ , MI = 4) and a styrene polymer (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. did. The resin composition of the inner adjacent layer (thickness: 10 μm) is a modified polyolefin (trade name: ADMER, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.890 g / cm ³ , MI =
4.0). The resin composition of the outermost layer of the sealant (thickness 30 μm) is 20 μm, and the resin composition is EVOH
(Product name: EVAL, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio: 44%) and styrene-based polymer (elastomer)
(Product name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.94
0 g / cm3, MI = 0.7) in a weight ratio of 95: 5. The temperature setting of the extruder is 170 to 240 ° C, the mold temperature is 180 to 250 ° C, and the film take-up speed is 8
Molding was performed at a fold diameter of 300 mm at １２12 m / min, and then both ends were cut. The polyethylene terephthalate film (thickness: 12 μm, manufactured by Toyobo Co., Ltd.) was dry-laminated with the sealant film using a urethane-based adhesive (trade name: Takerac Takenate, manufactured by Takeda Pharmaceutical Co., Ltd.). Using this lamination film, the outer dimension is 220 mm in the lateral direction so that the seal width is 10 mm,
An outer bag (three-sided seal) of the present invention having a length of 300 mm was prepared. Then, a 150 mm (horizontal) and 200 mm (longitudinal) polyethylene bag previously filled with 10 mL of a 10 w / v /% amino acid solution (trade name: Amipalene, manufactured by Otsuka Pharmaceutical Factory Co., Ltd.) is placed in this outer bag, and the upper part is heat-sealed. ,
The following experiment was performed to determine the suitability of the manufactured outer bag. (Example 23) The following sealant film was formed by a 5-type 5-layer air-cooled inflation film molding machine. The resin composition of the innermost layer (thickness: 50 μm) is composed of polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g / cm ³ , MI = 4) and ethylene α-olefin copolymer (trade name) Name: Tuffmer, Mitsui Petrochemical Industries
(Manufactured by Corporation, density: 0.880 g / cm3, MI = 4.0)
Further, a styrene-based polymer (elastomer) (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm)
3, MI = 0.7) in a weight ratio of 75:15:10. The resin composition of the inner adjacent layer (thickness 10 μm) is a modified polyolefin (trade name: Admer, Mitsui Petrochemical Industry Co., Ltd.)
Manufactured, density 0.930 g / cm ³ , MI = 4). The outer layer (thickness: 10 μm) is composed of EVOH (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer molar ratio: 44%) and styrene-based polymer (elastomer)
(Product name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.94
0 g / cm3, MI = 0.7) in a weight ratio of 95: 5. The resin composition of the sealant outermost layer (thickness 20 μm)
EVOH (trade name: Soarnol, Nippon Synthetic Chemical Industry Co., Ltd.)
, Ethylene copolymer molar ratio 44%). The temperature setting of the extruder is 150-220 ° C, the mold temperature is 170
℃ ~ 230 ℃, film take-up speed is 9 ~ 13m /
Then, a film was formed with a folding diameter of 300 mm and then both ends were cut. An adhesive is applied to this sealant film with a urethane-based adhesive (trade name: Takelac Taketake, Takeda Pharmaceutical)
Was dry-laminated with a polyethylene terephthalate film (thickness: 12 μm, manufactured by Toyobo Co., Ltd.). Using this lamination film, seal width 1
An outer bag (three-sided seal) of the present invention having an outer dimension of 220 mm in the horizontal direction and 300 mm in the vertical direction was prepared so as to be 0 mm.
Then, a 150 mm (horizontal) and 200 mm (longitudinal) polyethylene bag previously filled with 10 mL of a 10 w / v /% amino acid solution (trade name: Amipalene, manufactured by Otsuka Pharmaceutical Factory Co., Ltd.) is placed in this outer bag, and the upper part is heat-sealed. The following tests were performed to determine the suitability of the manufactured outer bag. (Example 24) The following sealant film was formed by a five-type five-layer air-cooled inflation film molding machine. The resin composition of the innermost layer (thickness: 50 μm) is made of polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density: 0.9).
10 g / cm ³ , MI = 4) and an ethylene α-olefin copolymer (trade name: Tuffmer, manufactured by Mitsui Petrochemical Industries, Ltd.)
Density: 0.880 g / cm3, MI = 4.0) Styrenic polymer (elastomer) (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm3, MI)
= 0.7) was set to 85: 5: 10 by weight ratio. The resin composition of the inner adjacent layer (thickness: 10 μm) was 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 outer layer (thickness: 10 μm) includes EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio: 44%) and styrene-based polymer (elastomer) (trade name: Hibler, Inc.) ) Kuraray, density: 0.940g /
cm3, MI = 0.7) in a weight ratio of 95: 5. The resin composition of the outermost layer (thickness: 20 μm) was EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio: 44%). The temperature setting of the extruder is 170 ℃ ～ 2
Molding was performed at 20 ° C., a mold temperature of 180 ° C. to 230 ° C., a film take-up speed of 11 to 14 m / min, and a folding diameter of 320 mm. The polyethylene terephthalate film (thickness: 12 μm, manufactured by Toyobo Co., Ltd.) was dry-laminated to the sealant film using a urethane-based adhesive (trade name: Takerac Takenate, manufactured by Takeda Pharmaceutical Co., Ltd.). Using this lamination film, an outer bag (three-sided seal) of the present invention having an outer dimension of 220 mm in the horizontal direction and 300 mm in the vertical direction was prepared so as to have a seal width of 10 mm. And 150 mm in the horizontal direction and 20 in the vertical direction previously filled with a 10 w / v /% amino acid solution (trade name: Amipalene, manufactured by Otsuka Pharmaceutical Factory Co., Ltd.)
A 0 mm polyethylene bag was put in this outer bag, the upper part was heat-sealed, and subjected to the following experiment to determine the suitability of the manufactured outer bag. (Example 25) The following sealant film was formed by a five-type five-layer water-cooled inflation film molding machine. The resin composition of the innermost layer (thickness: 50 μm) consists of polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.940 g / cm ³ , MI = 4) and styrene-based polymer (elastomer) (product) (Name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm3, MI = 0.7) was set to 90:10 by weight ratio. The resin composition of the inner adjacent layer (thickness 10 μm) is a modified polyolefin (trade name: Admer,
Mitsui Petrochemical Industries, Ltd., density 0.930 g / cm ³ ,
MI = 4). On the outer layer (thickness: 20 μm), EVOH (trade name: Soarnol, Nippon Synthetic Chemical Industry)
Co., Ltd., ethylene copolymer molar ratio 44%) and styrene-based polymer (elastomer) (trade name: Hibler, Inc.)
Made by Kuraray, density: 0.940 g / cm3, MI = 0.
7) was used in a weight ratio of 92: 8. The resin composition of the outermost layer of the sealant (thickness 10 μm) is nylon (trade name:
Novamid, manufactured by Mitsubishi Kasei Corporation, density 1.157 g / cm
³ ) The temperature setting of the extruder is 160 ° C ~ 240
C., the mold temperature was 170 ° C. to 250 ° C., the film take-up speed was 9 to 13 m / min, and the film was formed with a folding diameter of 300 mm. The polyethylene terephthalate film (thickness: 12 μm, manufactured by Toyobo Co., Ltd.) was dry-laminated with the sealant film using a urethane-based adhesive (trade name: Takerac Takenate, manufactured by Takeda Pharmaceutical Co., Ltd.). Using this lamination film, the outer dimension is 22 mm so that the seal width is 10 mm.
An outer bag (three-sided seal) of the present invention having a length of 0 mm and a length of 300 mm was prepared. A 10 w / v /% amino acid solution (trade name: Amipalene, manufactured by Otsuka Pharmaceutical Factory Co., Ltd.)
150mm horizontal, 200m vertical filled with 00mL
A polyethylene bag was placed in this outer bag, the upper part was heat-sealed, and subjected to the following experiment to determine the suitability of the manufactured outer bag. (Example 26) 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 polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.940 g / c)
m ³ , MI = 4) and a styrene-based polymer (elastomer) (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.
940 g / cm3, MI = 0.7) in a weight ratio of 90: 1.
0 was set. The resin composition of the intermediate layer (thickness 30 μm) is a modified polyolefin (trade name: ADMER, Mitsui Petrochemical Industries, Ltd.)
Co., Ltd., density 0.930 g / cm ³ , MI = 2) and cyclic polyolefin (trade name: Apel, Mitsui Petrochemical Industries, Ltd.)
Density: 1.02 g / cm ³ , MI = 30) Styrenic polymer (elastomer) (trade name: Hibler, manufactured by Kuraray Co., Ltd .; density: 0.940 g / cm 3, MI)
= 0.7) in a weight ratio of 80: 5: 15. The resin composition of the next outermost layer (thickness 30 μm) is EVOH (trade name:
Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer molar ratio: 44%). Extruder temperature setting is 16
0 ° C. to 240 ° C., mold temperature 180 ° C. to 250 ° C., film take-off speed 10 to 12 m / min, folding diameter 320 m
m and then cut at both ends. An adhesive is applied to the sealant film using a urethane-based adhesive (trade name: Takerac Takenate, manufactured by Takeda Pharmaceutical Co., Ltd.), a polyethylene terephthalate film (thickness: 12 μm, Toyobo Co., Ltd.)
Was subjected to dry lamination. Using this lamination film, an outer bag (three-sided seal) of the present invention having an outer dimension of 220 mm in the horizontal direction and 300 mm in the vertical direction was prepared so as to have a seal width of 10 mm. And 10w / v in advance
/ Amino acid solution (trade name: Amipalene, manufactured by Otsuka Pharmaceutical Factory Co., Ltd.) A polyethylene bag of 150 mm in width and 200 mm in length filled with a liquid volume of 500 mL was placed in the outer bag, the upper part was heat-sealed, and subjected to the following experiment. The eligibility of the manufactured outer bag was determined. (Comparative Example 5) The following sealant film was formed by a three-type three-layer air-cooled inflation film molding machine. The resin composition of the innermost layer (thickness: 50 μm) is polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Industries, Ltd., density: 0.94)
0 g / cm ³ , MI = 4). Inner adjacent layer (thickness 30μm)
Is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Industries, Ltd., density 0.930 g / cm)
³ , MI = 4). The resin composition of the outermost layer (thickness: 30 μm) of the sealant was EVOH (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer molar ratio: 44%). The temperature setting of the extruder is 150-220 ° C, the mold temperature is 170-230 ° C, and the film take-off speed is 1
A film was formed at a folding diameter of 300 mm at 0 to 13 m / min, and then both ends were cut. The polyethylene terephthalate film (thickness: 12 μm, manufactured by Toyobo Co., Ltd.) was dry-laminated with the sealant film using a urethane-based adhesive (trade name: Takerac Takenate, manufactured by Takeda Pharmaceutical Co., Ltd.). Using this lamination film, the outer dimension is 220 mm in the lateral direction so that the seal width is 10 mm,
An outer bag (three-sided seal) having a length of 300 mm was prepared. Then, a 150 mm (horizontal) and 200 mm (longitudinal) polyethylene bag previously filled with 500 mL of a 10 w / v /% amino acid solution (trade name: Amipalene, manufactured by Otsuka Pharmaceutical Factory) is placed in the outer bag, and the upper part is heat-sealed. And subjected to the following experiment.

In each of Examples 19 to 26 and Control Example 5, 100 mL of a 10 w / v /% amino acid solution (trade name: Amipalene, manufactured by Otsuka Pharmaceutical Factory Co., Ltd.) was placed on the outside of the bag.
The outer bag was sealed after adding a deoxidizer (Ageless, Mitsubishi Gas Chemical Co., Ltd.) for absorbing oxygen.

Test results 1) Stability test results after abuse of falling cardboard storage items (n
= 5) Specimens to be tested are stored in a low-temperature thermostat BNC-120 (set at 8 ° C) manufactured by Tabai Espec Co., Ltd. for 24 hours. Was served. Drop test condition is 60cm from concrete floor
From high, it conformed to the JIS-Z0202 drop condition.

After performing the drop test, each sample was taken out of the cardboard box, and a thermo-hygrostat manufactured by Tabai Espec Co., Ltd.
(Set at 40 ° C, 75% RH) Save in PR-4FT,
Three months later, the stability of the content drug (amino acid) was examined.
The content was determined by examining the individual content of the amino acid, and any one whose content was below the specified value was rejected.

[0059]

[Table 4]

From the above results, it can be seen that the outer bag of the present invention is particularly excellent in impact resistance and low-temperature strength.

[0061]

According to the present invention, a multilayer film having all the quality properties desired for medical use, such as transparency, impact resistance, low-temperature strength, heat resistance and stain resistance, as well as gas barrier properties, and its multilayer film are provided. Products such as medical containers and outer bags can be provided.

[Brief description of the drawings]

FIG. 1 is a plan view of a medical container constituted by the multilayer film of the present invention.

FIG. 2 is a partial longitudinal sectional view showing one embodiment of the multilayer film of the present invention.

FIG. 3 is a partial longitudinal sectional view showing another embodiment of the present invention.

FIG. 4 is a longitudinal sectional view showing still another embodiment of the present invention.

FIG. 5 is a partially cutaway plan view showing an example of an outer bag formed from the multilayer film of the present invention.

[Explanation of symbols]

 1 1st layer 2 2nd layer 3 3rd layer 4 4th layer 5 5th layer 6 outer layer

──────────────────────────────────────────────────の Continued on the front page (51) Int.Cl. ⁷ Identification symbol FI Theme coat ゛ (Reference) B32B 27/32 B32B 27/32 102 103 102 A61J 1/00 331C 103 370B

Claims (6)

[Claims] A first layer as an innermost layer, and at least a third layer made of an ethylene / vinyl alcohol copolymer laminated outside the first layer via a second layer as an adhesive layer. The second layer as the adhesive layer is composed of a modified polyolefin, and the first layer as the innermost layer is composed of a mixed resin containing a polypropylene resin and / or a polyethylene resin and a styrene resin. Characteristic multilayer film. 2. The mixed resin constituting the first layer contains 50 to 99% by weight of a polypropylene resin or a polyethylene resin and 1 to 50% by weight of a styrene resin. 2. The multilayer film according to 1. 3. The mixed resin constituting the first layer is selected from the group consisting of polybutene, ethylene / α-olefin copolymer and propylene / α-olefin copolymer as the third component in addition to the above two components. The multilayer film according to claim 1, wherein at least one of them is contained in an amount not exceeding 49% by weight. 4. A fifth layer as a protective layer containing a polypropylene-based resin or a polyethylene-based resin as a main component via a fourth layer as an adhesive layer made of modified polyolefin or nylon, on the outer surface side of the third layer. The multilayer film according to claim 1, wherein the multilayer film is formed. 5. The fifth layer as a protective layer, wherein at least one selected from the group consisting of styrene resin, polybutene, ethylene / α-olefin copolymer, and propylene / α-olefin copolymer as an additional component. 5. The multilayer film according to claim 4, comprising the resin of (1). 6. A medical container, an outer bag, and other products made of the multilayer film according to any one of claims 1 to 5.