JP4526133B2 - Medical container - Google Patents

Description

【００６７】
２）安定性試験結果（６０℃ ７５％ＲＨ、４週間、試料数＝５）
滅菌終了２４時間後に上記製造試料を条件（６０℃ ７５％ＲＨ）４週間保存し、内容医薬品の安定性を調べた。含量はアミノ酸の個別含量を調べ、１種類でも含量低下を認めた物は不合格と判定した。
【００６８】
【表２】

【００６９】
３）単品落下
滅菌終了２４時間後、上記のようにして製造した各種バッグをタバイエスペック（株）製低温高温槽ＢＮＣ−１２０（８℃に設定）に２４時間保存し、品温が１０℃以下になっていることを確認後、落下試験に供した。落下試験条件は６０ｃｍの高さから落下させた。
【００７０】
単品落下試験の評価は(1)ピンホールにつながるバッグの傷の有無、(2)バッグ並びにシール部の異常有無、(3)内溶液の漏出の有無の以上３点を目視確認した。
【００７１】
なお、試験に供した対照例１と対照例２は全て滅菌後の層間剥離をきたしていた。
【００７２】
【表３】

【００７３】
【発明の効果】
本発明によれば、透明性、耐衝撃性、柔軟性、ガスバリアー性、低温強度、耐熱性及び防汚染性など医療用として望まれる全ての品質性能を備えた多層フィルム性の医療用容器を提供できる。
【図面の簡単な説明】
【図１】本発明医療用容器の平面図である。
【図２】本発明医療用容器を構成している多層フィルムの一実施形態を示す拡大断面図である。
【図３】他の実施形態を示す拡大断面図である。
【図４】更に他の実施形態を示す拡大断面図である。
【符号の説明】
１ 中間層
２ 隣接層
３ 最内層
４ 最外層
５ 接着剤層[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a medical container, and more particularly to a medical container that is applied to storage of a medicine that is likely to deteriorate over time due to oxidation, moisture absorption, or the like.
[0002]
[Prior art]
Conventionally, pharmaceuticals that are difficult to maintain in stability due to oxidative degradation or hydrolysis are often filled and stored in glass containers, but glass containers are heavy, bulky, and easily damaged. However, ampoules have problems such as the generation of cut foreign substances during use, and recently, in consideration of the convenience of transportation and use, plastic containers represented by polyethylene and polypropylene have been changed.
[0003]
However, the plastic container has a large amount of gas such as water vapor, oxygen and carbon dioxide as compared with glass, and there is a problem in terms of quality and performance in the application to pharmaceuticals whose stability is difficult to maintain by oxidative decomposition or hydrolysis. It was.
[0004]
Recently, as one of the measures to solve the above-mentioned quality performance problems, outer packaging is applied to plastic containers using a gas barrier film, and if necessary, oxygen scavenger, desiccant, etc. between the container and outer packaging. A proposal has been made to accommodate
[0005]
Conventionally, as gas barrier films for medical use, silica-deposited polyethylene terephthalate film, alumina-deposited film, aluminum laminate film, polyvinyl alcohol film, ethylene / vinyl alcohol copolymer film, polyvinylidene chloride film, etc. have been proposed. However, since these gas barrier films are generally hard, pinholes are likely to occur due to vibration during transportation and the like, and the content retention stability is not sufficient. In addition, since the gas barrier film is hard and bulky, it has been pointed out that there is a dust problem when it is discarded after use.
[0006]
On the other hand, it is conceivable to construct a medical container directly from the gas barrier film, but practical application is difficult due to the following problems (1) and (2).
[0007]
(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.
[0008]
(2) Since the film itself is stiff, there is a problem in strength, particularly impact resistance and flexibility. However, among the above gas barrier films, the aluminum laminate film can clear the above problems (1) and (2), but the film is opaque and used in addition to the problem that the contents cannot be seen from the outside. The adhesive component that permeates through the plastic film moves to the contents side and contaminates the contents, and it is difficult to put it to practical use as in the case of the gas barrier film.
[0009]
[Problems to be solved by the invention]
The present invention eliminates the above-mentioned conventional problems, and has all the quality performances desired for medical use such as transparency, flexibility, impact resistance, low temperature strength, heat resistance and antifouling properties as well as gas barrier properties. It was made for the purpose of providing a medical container.
[0010]
[Means for Solving the Problems]
The present invention relates to 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, directly on the inner surface side of the intermediate layer. An inner adjacent layer is formed so as to be in contact with the inner adjacent layer, a resin having a modified polyolefin as a main component, a first mixed resin having a modified polyolefin and a styrene resin as main components, or a polypropylene resin and a styrene resin. It is related with the medical container characterized by being comprised from 2nd mixed resin which has as a main component.
[0011]
In the present invention, the mixed resin constituting the intermediate layer preferably contains at least 50% by weight of ethylene / vinyl alcohol copolymer and at least 5% by weight of styrene resin.
[0012]
The first mixed resin constituting the inner adjacent layer preferably contains at least 10% by weight of modified polyolefin and at least 5% by weight of styrene resin.
[0013]
The second mixed resin constituting 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. In addition to the two components, a modified polyolefin is used as a third component. In a range not exceeding 20% by weight.
[0014]
An outer adjacent layer can be formed on the outer surface side of the intermediate layer. The outer adjacent layer, like the inner adjacent layer, is mainly composed of a resin composed mainly of a modified polyolefin, a first mixed resin composed mainly of a modified polyolefin and a styrene resin, or a polypropylene resin and a styrene resin. The second mixed resin may be made of, and may also be made of nylon.
[0015]
An innermost layer as a heat seal layer made of a mixed resin mainly composed of a polypropylene resin and a styrene resin can be formed on the inner surface side of the inner adjacent layer. The innermost layer may contain a thermoplastic resin other than the two components as the third component in addition to the two components.
[0016]
The outermost layer as the protective layer may be formed outside the intermediate layer directly or via an outer adjacent layer. When the outermost layer is formed directly on the outer side of the intermediate layer, the outermost layer can be composed of, for example, a resin mainly composed of polyolefin, and can be bonded to the intermediate layer via an adhesive or an adhesive layer. it can.
[0017]
On the other hand, when the outermost layer is formed outside the intermediate layer via an outer adjacent layer, the outermost layer is mainly composed of, for example, a polypropylene resin and a styrene resin, and other thermoplastic resins are added as necessary. It can be comprised from the mixed resin. Since such a mixed resin is suitable for adhesion to the modified polyolefin, the first and second mixed resins, or nylon constituting the outer adjacent layer, it can be integrally formed by applying an extrusion molding means to the outer adjacent layer.
[0018]
DETAILED DESCRIPTION OF THE INVENTION
An embodiment of the present invention will be described below with reference to the accompanying drawings.
[0019]
FIG. 1 shows the medical container A of the present invention, and FIGS. 2 to 4 show various embodiments of the multilayer film A1 constituting the medical container A of the present invention.
[0020]
The multilayer film A1 includes an intermediate layer 1 made of a mixed resin of an ethylene / vinyl alcohol copolymer (hereinafter referred to as EVOH) and a styrene resin.
[0021]
Among the above mixed resins, EVOH is a resin having excellent gas barrier properties and functions to impart gas barrier properties to the intermediate layer 1. EVOH needs to occupy at least 50 weight percent of the total weight, and is usually selected appropriately from the range of 50 to 95 weight percent.
[0022]
On the other hand, a styrene resin, particularly an elastomer thereof, is a resin excellent in heat resistance and low temperature elasticity, and functions to impart heat resistance and low temperature strength to the layer 1. The styrenic resin needs to occupy at least 5% by weight of the total weight, and is usually selected appropriately from the range of 5 to 50% by weight.
[0023]
The intermediate layer 1 composed of such a mixed resin is excellent in gas barrier properties, heat resistance and low-temperature strength, and contains a styrene resin, so that the hardness tends to be less than that of EVOH alone, and even when subjected to vibration or the like. It becomes difficult to generate pinholes. EVOH and styrene-based resin are both transparent, and can secure the transparency required for medical containers.
[0024]
An inner adjacent layer 2 is formed on the intermediate layer 1 so as to be in direct contact with the inner adjacent layer 2. The inner adjacent layer 2 is a first mixed resin mainly composed of a modified polyolefin and a styrene resin. It is comprised from 2nd mixed resin which has resin or a polypropylene resin and a styrene resin as a main component.
[0025]
Among the resins constituting the inner adjacent layer 2, the modified polyolefin or polypropylene resin is excellent in 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, the modified polyolefin or polypropylene-based resin needs to occupy at least 10% by weight of the total weight, usually 10 to 95% by weight. % Is appropriately selected from the range of%.
[0026]
When the inner adjacent layer 2 is composed of the first mixed resin or the second mixed resin, the styrene resin as one component of these mixed resins is superior in heat resistance and elasticity at low temperatures as described above. Therefore, heat resistance and low temperature strength can be imparted to the inner adjacent layer 2. The styrenic resin is required to occupy at least 5% by weight of the total weight, and is usually appropriately selected from the range of 5 to 70% by weight. These first or second mixed resins may contain at least 10% by weight of a modified polyolefin in order to improve the adhesion with adjacent layers.
[0027]
The inner adjacent layer 2 composed of the modified polyolefin alone, the first mixed resin or the second mixed resin is flexible and has a moderate elasticity, and has a slight cushioning property, and functions to protect the intermediate layer 1 from impact. , Also has transparency. Further, when the inner adjacent layer 2 contains a styrene resin, improved impact resistance, low temperature strength and heat resistance can be obtained.
[0028]
When a modified polyolefin is used for the inner adjacent layer 2, it has a functional group having a polarity such as a hydroxyl group (—OH) found in EVOH in its molecule, so that the EVOH of the intermediate layer 1 is bonded to the modified polyolefin. Property is improved.
[0029]
In the case of using a styrenic tree for the inner adjacent layer 2, the interlayer adhesion between the EVOH of the intermediate layer 1 and the polypropylene resin of the inner adjacent layer 2 is weak, but the styrene resin that is a component common to both layers The adhesion strength that can withstand high-pressure steam sterilization treatment (for example, 121 ° C., 20 minutes) from the fact that there is good adhesion between EVOH and styrene resin, and that polypropylene and styrene resin are heat resistant. can get.
[0030]
As shown in FIG. 2, in addition to the inner adjacent layer 2, the intermediate layer 1 can include an outer adjacent layer 2 'on the outer side. In this case, the intermediate layer 1 is protected from the inner and outer sides by the inner and outer adjacent layers 2 and 2 '. The inner adjacent layer 2 also serves as a heat seal layer.
[0031]
The outer adjacent layer 2 ′, like the inner adjacent layer 2, is 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. It can comprise from the 2nd mixed resin which has as a main component. In addition, EVOH constituting the intermediate layer 1 functions to prevent migration of harmful components caused by hydrolysis and the like to the inner layer side, so that the outer adjacent layer 2 'has flexibility, impact resistance and transparency. This makes it possible to apply nylon that excels in resistance.
[0032]
As shown in FIG. 3, the innermost layer 3 as a heat seal layer is applied to the inner surface side of the inner adjacent layer 2, and the outermost layer 4 as a protective layer is applied to the outer surface side of the outer adjacent layer 2 ′. And can be integrally formed.
[0033]
The innermost layer 3 and the outermost layer 4 can be composed of a mixed resin of a polypropylene resin and a styrene resin. In addition to these two components, a thermoplastic resin other than these, for example, polyethylene, polybutene, poly- It may contain 4-methylpentene, cyclic hydrocarbon resin, ethylene-vinyl acetate copolymer, ethylene-ethyl acrylate copolymer, ethylene-acrylate copolymer, ethylene-methacrylic acid copolymer, modified polyolefin, etc. . The third component is useful for obtaining blocking resistance and easy peel sealability in the innermost layer 3 and for obtaining blocking resistance in the outermost layer 4. The mixing ratio of each component of the mixed resin is suitably 25 to 90% by weight of polypropylene resin, 5 to 70% by weight of styrene resin, and 5 to 50% by weight of other thermoplastic resins.
[0034]
FIG. 4 shows a case in which only the inner adjacent layer 2 is provided in the intermediate layer 1 and the outer adjacent layer 2 ′ is omitted. In this case, the inner side of the inner adjacent layer 2 is the same as the type shown in FIG. The innermost layer 3 can be formed as a heat seal layer.
[0035]
Moreover, the outermost layer 4 which has polyolefin resin, such as polyethylene and a polypropylene, as a main component can be formed in the outer surface side of the intermediate | middle layer 1 as a protective layer. In this case, since the above-mentioned polyolefin and the EVOH of the intermediate layer 1 are not very suitable for adhesion, an adhesive (for example, modified polyolefin) or an adhesive layer 5 (for example, nylon) is applied between the layers. In the latter case, the adhesive layer 5 serves to reinforce the intermediate layer 1.
[0036]
In the present invention, the styrenic resin is not particularly limited to homopolymers and copolymers, but the following elastomers are preferred.
[0037]
Styrene elastomers: 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-ethylene butylene, polystyrene-ethylene butylene-polystyrene, Polystyrene-ethylenebutylene-polyethylene, police Len - ethylene butylene - 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 modified polyolefin as used herein refers to, for example, those obtained by reacting a polyolefin with an α, β-unsaturated carboxylic acid or acid anhydride thereof. Specific examples thereof include, for example, maleic anhydride-modified polyethylene. And maleic anhydride-modified polypropylene, ethylene / ethyl acrylate / maleic anhydride copolymer, and ethylene / vinyl acetate / maleic anhydride copolymer.
[0038]
The polypropylene resin may be any of a homopolymer (including amorphous and low crystallinity) and a copolymer (for example, a random polymer and a block polymer).
[0039]
Since the multilayer film which comprises the medical container of this invention is equipped with the intermediate | middle layer which contains EVOH as a main component, it is equipped with the gas barrier property peculiar to EVOH.
[0040]
Further, since the intermediate layer 1 contains a styrene resin, the hardness of EVOH tends to be softened by the styrene resin, and the inner adjacent layer 2 functions to alleviate the impact. Therefore, the intermediate layer 1 is mainly composed of EVOH. In spite of this, pinholes and cracks do not occur even when subjected to an impact, and the gas barrier property can be maintained stably for a long period of time. Such performance can be further improved by providing the outer adjacent layer in addition to the inner adjacent layer.
[0041]
Further, the intermediate layer 1 is improved in flexibility, low-temperature strength and heat resistance by the styrene resin contained therein, and the intermediate layer 1 and the inner adjacent layer 2 contain a styrene resin as a common component or the inner adjacent layer. 2 contains a modified polyolefin having good adhesion to the EVOH of the intermediate layer 1, so that there is no risk of delamination during high-pressure steam sterilization due to high adhesion strength between layers.
[0042]
Further, the inner adjacent layer 2 is directly formed on the inner side of the intermediate layer 1, and it is not necessary to provide an adhesive layer that causes contamination on the inner side of the intermediate layer 1, and the intermediate layer 1 is superior in its quality. The barrier property prevents migration of pollutants from the outside to the inside, so that the contents are not contaminated by the pollutants, thereby providing antifouling properties.
[0043]
Furthermore, not only 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. All are transparent and the transparency required as a medical container is obtained.
The following are examples of the present invention, and the results of comparative experiments with the control examples are as follows.
[0044]
[Example 1]
Inner adjacent layer 60 μm: Polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm ^Three , MI = 4) and styrenic elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm) ^Three , MI = 0.7) 2 types of resin by weight ratio 5: 5, intermediate layer 30 μm: ethylene vinyl alcohol (hereinafter EVOH) (trade name: Eval, Kuraray Co., Ltd., ethylene copolymer molar ratio 44% ) And styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI = 0.7), a weight ratio of 7: 3, outer adjacent layer 120 μm: polypropylene (trade name: HIPOL, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm) ^Three , MI = 4) and styrenic elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm) ^Three , MI = 0.7), and a resin having a weight ratio of 5: 5 mixed into a film having a width of 480 mm and a thickness of 210 μm by the T-die method (temperature 160 to 230 ° C.). Each film was cut into a length of about 1000 mm in the take-off direction. This film is folded in two so as to make a bag with a length of 250 mm, and the upper and lower molds are folded at a temperature condition of 180 ° C. to 195 ° C. so that the seal width is 10 mm. 3 places were heat sealed. In this way, a bag (bag) having an outer dimension of 200 mm in the lateral direction and 250 mm in the vertical direction, in which three directions were welded, was produced. And density in opening part: 0.910 g / cm ^Three Port portions made of polypropylene were thermally welded. A polypropylene cap (density: 0.910 g / cm) filled with 10 W / V% amino acid solution (amipalene solution) from the port and fitted with a rubber plug that passed Japanese Pharmacopoeia (13th revision). ^Three ). The 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 to determine the suitability of the manufactured bag.
[0045]
[Example 2]
The following films were formed using a five-kind five-layer water-cooled inflation film molding machine. Resin composition is outermost layer 60 μm: linear low density polyethylene (trade name: Ultozex, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.940 g / cm ^Three , MI = 2), adhesive layer 10 μm: modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.940 g / cm ^Three , MI = 2), intermediate layer 30 μm: EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio 38%) and styrene elastomer (trade name: manufactured by Hibler, Kuraray Co., Ltd., density: 0) .940g / cm ^Three , MI = 0.7) of two types of resin in a weight ratio of 7: 3, inner adjacent layer 60 μm: polypropylene (trade name: HIPOL, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm) ^Three , MI = 6) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI = 0.7) by weight ratio 5: 5, innermost layer 50 μm: polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm ^Three , MI = 8) and linear low-density polyethylene (trade name: ULTZEX, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.940 g / cm ^Three , MI = 2) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI = 0.7), and a weight ratio of 6: 3: 1.
[0046]
The extruder was molded at a temperature setting of 140 ° C. to 215 ° C., a mold temperature of 160 ° C. to 230 ° C., and a film take-up speed of 8 to 10 m / min. The thickness of the film was 210 μm and the fold diameter was 300 mm. The upper and lower molds were heat sealed at a temperature condition of 165 ° C. to 190 ° C. so that the seal width was 10 mm, and a bag (bag) having outer dimensions of 200 mm in the horizontal direction and 250 mm in the vertical direction was produced. And density in opening part: 0.910 g / cm ^Three A port portion made of polypropylene was thermally welded.
[0047]
A polypropylene cap (density: 0.910 g / cm) filled with 500 ml of amiparene solution which is 10 w / v /% amino acid injection solution from this port and fitted with a rubber plug that passed Japanese Pharmacopoeia (13th revision). ^Three ). This pug was left at room temperature for 24 hours after autoclaving at 118 ° C. for 40 minutes and subjected to the following experiment.
[0048]
[Example 3]
The following films were formed using a five-kind five-layer water-cooled inflation film molding machine. The composition of the mixed resin of the innermost layer (thickness 50 μm) is high density polyethylene (trade name: Neozex, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.960 g / cm ^Three , MI = 15) and polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm) ^Three , MI = 8), styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was 15:70:15 by weight. The resin composition of the inner adjacent layer (thickness 30 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm ^Three , MI = 8) and styrenic elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm) ^Three , MI = 0.7) and modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.910 g / cm) ^Three , MI = 8) were mixed at a weight ratio of 20:10:20. The mixed resin composition of the intermediate layer (thickness 40 μm) consists of EVOH (trade name: Soarnol, Nippon Synthetic Chemical Co., Ltd., ethylene copolymer molar ratio 44%) and styrene elastomer (trade name: Dynalon, Nippon Synthetic Rubber ( Co., Ltd., density: 0.89 g / cm ^Three , MI = 3.5) with a weight ratio of 9: 1, and the resin composition of the outer adjacent layer (thickness 30 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density: 0.00). 910 / cm ^Three , MI = 8) and styrene elastomer (trade name: Dynalon, manufactured by Nippon Synthetic Rubber Co., Ltd., density: 0.89 g / cm ^Three , MI = 3.5) and modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.910 g / cm) ^Three , 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) is high density polyethylene (trade name: Neozex, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.960 g / cm ^Three , MI = 15) and polypropylene (trade name: Hypol, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm) ^Three , MI = 8) and styrene-based elastomer (trade name: Dynalon, manufactured by Nippon Synthetic Rubber Co., Ltd., density: 0.890 g / cm ^Three , MI = 3.5) was 15:70:15 by weight. Molding was performed at an extruder temperature setting of 150 to 220 ° C., a mold temperature of 160 to 225 ° C., and a film take-off speed of 7 to 10 m / min. The thickness of the film was 200 μm, and the fold diameter was 330 mm. Using this inflation film, the upper and lower molds are heat sealed at a temperature condition of 165 ° C. to 190 ° C. so that the seal width is 10 mm, and a bag (bag) having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction is obtained. Produced. And density in opening part: 0.910 g / cm ^Three Port portions made of polypropylene were thermally welded. A polypropylene cap (density: 0.910 g / cm) filled with 500 ml of 10 w / v /% amino acid solution (amipalene) from the port part of this bag and fitted with a rubber stopper that passed the Japanese Pharmacopoeia (13th revision). ^Three ). This bag was left at room temperature for 24 hours after autoclaving at 121 ° C. for 20 minutes and subjected to the following experiment to determine the suitability of the manufactured bag.
[0049]
[Example 4]
The following films were formed using a five-kind five-layer water-cooled inflation film molding machine. The resin composition of the innermost layer (thickness 50 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm ^Three , MI = 3) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was 80:20 by weight. The resin structure of the inner adjacent layer (thickness 30 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm). ^Three , MI = 3) and modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.940 g / cm) ^Three , MI = 2) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm) ^Three MI = 0.7) was 30:50:20 by weight. The resin composition of the intermediate layer (thickness 30 μm) is EVOH (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Co., Ltd., ethylene copolymer molar ratio 44%) and styrene elastomer (trade name: Hybler, manufactured by Kuraray Co., Ltd.). , Density: 0.940 g / cm ^Three MI = 0.7) was 80:20 by weight. Outer adjacent layer (thickness 30 μm) polypropylene (trade name: Hipole, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm ^Three , MI = 3) and modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.940 g / cm) ^Three , MI = 2) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm) ^Three MI = 0.7) was 30:50:20 by weight. The resin composition of the outermost layer (thickness 50 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm ^Three , MI = 3) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI = 0.7) and linear low density polyethylene (trade name: Ultozex, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.940 g / cm) ^Three , MI = 2) at a weight ratio of 20:70:10. The temperature setting of the extruder was 160 ° C. to 220 ° C., the mold temperature was 165 ° C. to 225 ° C., the film take-up speed was 9 to 12 m / min, and the folding diameter was 500 mm. Using this inflation film, a bag (bag) having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was produced so as to have a seal width of 10 mm. And density in opening part: 0.910 g / cm ^Three Port portions made of polypropylene were thermally welded. From this port portion, 500 ml of 10 w / v /% amino acid solution (amipalene) was filled, and a rubber plug that passed the Japanese Pharmacopoeia (13th revision) was heat welded. The bag was left at room temperature for 24 hours after autoclaving 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 films were formed using a five-kind five-layer water-cooled inflation film molding machine. The resin composition of the innermost layer (thickness 50 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm ^Three , MI = 3) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI = 0.7) and linear low density polyethylene (trade name: Ultozex, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.940 g / cm) ^Three , MI = 2) at a weight ratio of 10: 5: 85. The resin structure of the inner adjacent layer (thickness: 40 μm) is polypropylene (trade name: Hipole, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm). ^Three , MI = 3) and modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.940 g / cm) ^Three , MI = 2) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm) ^Three , MI = 0.7) were mixed at a weight ratio of 15: 80: 5. The resin composition of the intermediate layer (thickness 25 μm) is EVOH (trade name: Soarnol, Nippon Synthetic Chemical Co., Ltd., ethylene copolymer molar ratio 44%) and styrene elastomer (trade name: Hybler, Kuraray Co., Ltd.). , Density: 0.940 g / cm ^Three MI = 0.7) was 90:10 by weight. Outer adjacent layer (thickness 40 μm) polypropylene (trade name: Hipole, manufactured by Grand Polymer Co., Ltd., density: 0.910 / cm ^Three , MI = 3) and modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.940 g / cm) ^Three , MI = 2) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm) ^Three MI = 0.7) was a weight ratio of 15: 80: 5. The resin composition of the outermost layer (thickness 50 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm ^Three , MI = 3) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three , MI = 0.7) and linear low density polyethylene (trade name: Ultozex, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.940 g / cm) ^Three , MI = 2) at a weight ratio of 10: 5: 85. Molding was performed at an extruder temperature setting of 150 to 220 ° C., a mold temperature of 160 to 225 ° C., and a film take-up speed of 9 to 13 m / min. The fold diameter of the film was 500 mm. Using this inflation film, the upper and lower molds were heat-sealed at 165 ° C to 190 ° C at a temperature of 165 ° C to 190 ° C so that the seal width would be 10 mm. Produced. And density in opening part: 0.945g / cm ^Three Port portions made of polyethylene were thermally welded. A polyethylene cap (density: 0.945 g / cm) filled with 500 ml of 10 w / v /% amino acid solution (amipalene) from the port portion of this bag and fitted with a rubber stopper that passed Japanese Pharmacopoeia (13th revision). ^Three ). The bag was left at room temperature for 24 hours after autoclaving at 118 ° C. for 40 minutes, and subjected to the following experiment to determine the suitability of the manufactured bag.
[0051]
[Example 6]
The following films were formed using a 5-type 5-layer air-cooled inflation film molding machine. The resin composition of the innermost layer (thickness 30 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm ^Three , MI = 4) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was 80:20 by weight. The resin composition of the inner adjacent layer (thickness 30 μm) is modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.910 g / cm ^Three , MI = 3) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was 90:10 by weight. The resin composition of the intermediate layer (thickness: 40 μm) is EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio 44%) and styrene elastomer (trade name: Hybler, manufactured by Kuraray Co., Ltd., density). : 0.940 g / cm ^Three MI = 0.7) was 95: 5 by weight. The resin composition of the outer adjacent layer (thickness 30 μm) is modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.910 g / cm). ^Three , MI = 3) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was 90:10 by weight. The resin composition of the outermost layer (thickness 50 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm ^Three , MI = 6) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was 90:10 by weight. Molding was performed at an extruder temperature setting of 170 ° C. to 220 ° C., a mold temperature of 180 ° C. to 230 ° C., a film take-up speed of 7.5 to 12 m / min, and a folding diameter of 520 mm. Using this inflation film, a bag (bag) having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was prepared so as to have a seal width of 10 mm. In addition, polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm at the opening part) ^Three , MI = 6) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was blended at a weight ratio of 90:10, and the injection-molded port part was heat-sealed. This port is filled with 500 ml of 10 w / v /% amino acid solution (amipalene), left at room temperature for 24 hours after high-pressure steam sterilization at 118 ° C. for 40 minutes, and subjected to the following experiment. Judged.
[0052]
[Example 7]
The following films were formed using a 5-type 5-layer air-cooled inflation film molding machine. The resin composition of the innermost layer (thickness 30 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm ^Three , MI = 4) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was 80:20 by weight. The resin composition of the inner adjacent layer (thickness 30 μm) is modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.890 g / cm). ^Three , MI = 3) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was 90:10 by weight. The resin composition of the intermediate layer (thickness: 40 μm) is EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio 44%) and styrene elastomer (trade name: Hybler, manufactured by Kuraray Co., Ltd., density). : 0.940 g / cm ^Three MI = 0.7) was 95: 5 by weight. The resin composition of the outer adjacent layer (thickness 30 μm) is modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.890 g / cm ^Three MI = 3). The resin composition of the outermost layer (thickness 50 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm ^Three MI = 4). The extruder was set at a temperature of 170 ° C. to 220 ° C., a mold temperature of 180 ° C. to 230 ° C., a film take-up speed of 9 to 12 m / min, and a folding diameter of 520 mm. Using this inflation film, a bag (bag) having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was produced so as to have a seal width of 10 mm. In addition, polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm at the opening part) ^Three , MI = 6) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was blended at a weight ratio of 90:10, and the injection-molded port part was heat-sealed. This port is filled with 500 ml of 10 w / v /% amino acid solution (amipalene), left at room temperature for 24 hours after high-pressure steam sterilization at 118 ° C. for 40 minutes, and subjected to the following experiment. Judged.
[0053]
[Example 8]
The following films were formed using a 5-type 5-layer air-cooled inflation film molding machine. The resin composition of the innermost layer (thickness 50 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm). ^Three , MI = 4) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was 80:20 by weight. The resin composition of the inner adjacent layer (thickness 30 μm) is modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.910 g / cm ^Three 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 styrene elastomer (trade name: HYBRA, manufactured by Kuraray Co., Ltd., density) : 0.940 g / cm ^Three MI = 0.7) was 95: 5 by weight. The resin composition of the outer adjacent layer (thickness 30 μm) is modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.910 g / cm). ^Three MI = 3). The resin composition of the outermost layer (thickness 50 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm ^Three , MI = 6) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was 90:10 by weight. Molding was performed at an extruder temperature setting of 170 ° C. to 220 ° C., a mold temperature of 180 ° C. to 230 ° C., a film take-up speed of 7.5 to 12 m / min, and a folding diameter of 520 mm. Using this inflation film, a bag (bag) having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was produced so as to have a seal width of 10 mm. In addition, polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm at the opening part) ^Three , MI = 6) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was blended at a weight ratio of 90:10, and the injection-molded port part was heat-sealed. This port is filled with 500 ml of 10 w / v /% amino acid solution (amipalene), left at room temperature for 24 hours after high-pressure steam sterilization at 118 ° C. for 40 minutes, and subjected to the following experiment. Judged.
[0054]
[Example 9]
The following films were formed using a five-kind five-layer water-cooled inflation film molding machine. The resin composition of the innermost layer (thickness: 60 μm) is made of polyethylene (trade name: ULTZEX, manufactured by Mitsui Petrochemical Co., Ltd., density 0.930 g / cm ^Three , MI = 2.0) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm) ^Three MI = 0.7) was 95: 5 by weight. The resin structure of the inner adjacent layer (thickness 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.930 g / cm). ^Three MI = 2.0). The resin composition of the intermediate layer (thickness 30 μm) is EVOH (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer molar ratio 44%) and styrene elastomer (trade name: Hybler, Kuraray Co., Ltd.). Product, density: 0.940 g / cm ^Three MI = 0.7) was 90:10 by weight. The resin configuration of the outer adjacent layer (thickness 30 μm) is nylon (trade name: Novamid, manufactured by Mitsubishi Kasei Co., Ltd., density 1.140 g / cm ^Three ). The resin composition of the outermost layer (thickness: 50 μm) is polyethylene (trade name: ULTZEX, manufactured by Mitsui Petrochemical Co., Ltd., density 0.930 g / cm ^Three , MI = 3) and styrene-based elastomer (trade name: Dynalon, manufactured by Nippon Synthetic Rubber Co., Ltd., density: 0.910 g / cm ^Three MI = 0.7) was 90:10 by weight. The extruder was set at a temperature of 170 ° C. to 250 ° C., a mold temperature of 180 ° C. to 265 ° C., a film take-up speed of 10 to 12 m / min, and a folding diameter of 520 mm. Using this inflation film, a bag (bag) having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was produced so as to have a seal width of 10 mm. In addition, polyethylene (trade name: Ultozex, manufactured by Mitsui Petrochemical Co., Ltd., density 0.945 g / cm at the opening part) ^Three , MI = 8) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was blended at a weight ratio of 90:10, and the injection-molded port part was heat-sealed. This port is filled with 500 ml of 10 w / v /% amino acid solution (amipalene), left at room temperature for 24 hours after high-pressure steam sterilization at 118 ° C. for 40 minutes, and subjected to the following experiment. Judged.
[0055]
[Example 10]
The following films were formed using a five-kind five-layer water-cooled inflation film molding machine. The resin composition of the innermost layer (thickness 50 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm). ^Three , MI = 4) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was 80:20 by weight. The resin composition of the inner adjacent layer (thickness 30 μm) is modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.890 g / cm). ^Three MI = 5.7). The resin composition of the intermediate layer (thickness 40 μm) is EVOH (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer molar ratio 44%) and styrene elastomer (trade name: Hybler, Kuraray Co., Ltd.). Product, density: 0.940 g / cm ^Three MI = 0.7) was 90:10 by weight. The resin composition of the outer adjacent layer (thickness 30 μm) is modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.890 g / cm ^Three MI = 5.7). The resin composition of the outermost layer (thickness 20 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm ^Three MI = 4). The extruder was set at a temperature of 170 ° C. to 220 ° C., a mold temperature of 180 ° C. to 230 ° C., a film take-up speed of 9 to 12 m / min, and a folding diameter of 520 mm. Using this inflation film, a bag (bag) having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was produced so as to have a seal width of 10 mm. In addition, polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm at the opening part) ^Three , MI = 6) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was blended at a weight ratio of 90:10, and the injection-molded port part was heat-sealed. This port is filled with 500 ml of 10 w / v /% amino acid solution (amipalene), left at room temperature for 24 hours after high-pressure steam sterilization at 118 ° C. for 40 minutes, and subjected to the following experiment. Judged.
[0056]
Example 11
The following films were formed using a five-kind five-layer water-cooled inflation film molding machine. The resin composition of the innermost layer (thickness: 50 μm) is polyethylene (trade name: ULTZEX, manufactured by Mitsui Petrochemical Co., Ltd., density 0.940 g / cm). ^Three , MI = 3) and ethylene α-olefin copolymer (trade name: Tafmer, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.880 g / cm ^Three , MI = 4) was 80:20 by weight. The resin structure of the inner adjacent layer (thickness 30 μm) is a modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.940 g / cm). ^Three MI = 1.3). 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 styrene elastomer (trade name: HYBRA, manufactured by Kuraray Co., Ltd., density) : 0.940 g / cm ^Three MI = 0.7) was 90:10 by weight. The resin composition of the outer adjacent layer (thickness 30 μm) is modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.940 g / cm ^Three MI = 1.3). The resin composition of the outermost layer (thickness 30 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm ^Three , MI = 6). The temperature setting of the extruder was 170 ° C. to 220 ° C., the mold temperature was 180 ° C. to 230 ° C., the film take-up speed was 10 to 12 m / min, and the folding diameter was 520 mm. Using this inflation film, a bag (bag) having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was produced so as to have a seal width of 10 mm. In addition, polyethylene (trade name: Ultozex, manufactured by Mitsui Petrochemical Co., Ltd., density 0.945 g / cm at the opening part) ^Three , MI = 6) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was blended at a weight ratio of 90:10, and the injection-molded port part was heat-sealed. Filled with 500 ml of 10 w / v /% amino acid solution (amipalene) from this port, 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. Judged.
[0057]
Example 12
The following films were formed using a five-kind five-layer water-cooled inflation film molding machine. The resin composition of the innermost layer (thickness 30 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm ^Three , MI = 4) and ethylene α-olefin copolymer (trade name: Toughmer, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.880 g / cm ^Three , MI = 4.0) was 90:10 by weight. The resin composition of the inner adjacent layer (thickness 30 μm) is modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.890 g / cm). ^Three MI = 5.7). The resin composition of the intermediate layer (thickness: 30 μm) is EVOH (trade name: EVAL, manufactured by Kuraray Co., Ltd., ethylene copolymer molar ratio 44%) and styrene elastomer (trade name: Hybler, manufactured by Kuraray Co., Ltd., density) : 0.940 g / cm ^Three MI = 0.7) was 95: 5 by weight. The resin configuration of the outer adjacent layer (thickness 30 μm) is nylon (trade name: Novamimid, manufactured by Mitsubishi Kasei Co., Ltd., density 1.152 g / cm ^Three ). The resin composition of the outermost layer (thickness: 50 μm) is polyethylene (trade name: Ultzex, manufactured by Mitsui Petrochemical Co., Ltd., density 0.940 g / cm ^Three MI = 3). Molding was performed at an extruder temperature setting of 150 ° C. to 250 ° C., a mold temperature of 170 ° C. to 265 ° C., a film take-up speed of 10 to 14 m / min, and a folding diameter of 520 mm. Using this inflation film, a bag (bag) having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was produced so as to have a seal width of 10 mm. In addition, polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm at the opening part) ^Three , MI = 6) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was blended at a weight ratio of 90:10, and the injection-molded port part was heat-sealed. Filled with 500 ml of 10 w / v /% amino acid solution (amipalene) from this port, 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. Judged.
[0058]
Example 13
The following films were formed using a 5-type 5-layer air-cooled inflation film molding machine. The resin composition of the innermost layer (thickness: 40 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm ^Three , MI = 4) and polyptenic polymer (trade name: buron, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.890 g / cm ^Three , MI = 0.2) was 70:30 by weight. The resin composition of the inner adjacent layer (thickness 30 μm) is modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.890 g / cm). ^Three MI = 5.7). The resin composition of the intermediate layer (thickness 30 μm) is EVOH (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer molar ratio 44%) and styrene elastomer (trade name: Hybler, Kuraray Co., Ltd.). Product, density: 0.940 g / cm ^Three MI = 0.7) was 95: 5 by weight. The resin configuration of the outer adjacent layer (thickness 30 μm) is nylon (trade name: Novamimid, manufactured by Mitsubishi Kasei Co., Ltd., density 1.152 g / cm ^Three ). The resin composition of the outermost layer (thickness: 30 μm) is polyethylene (trade name: ULTZEX, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.930 g / cm ^Three , MI = 2). The temperature setting of the extruder was 150 ° C. to 250 ° C., the mold temperature was 160 ° C. to 265 ° C., the film take-up speed was 10 to 12 m / min, and the folding diameter was 520 mm. Using this inflation film, a bag (bag) having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was produced so as to have a seal width of 10 mm. In addition, polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm at the opening part) ^Three , MI = 6) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was blended at a weight ratio of 90:10, and the injection-molded port part was heat-sealed. This port is filled with 500 ml of 10 w / v /% amino acid solution (amipalene), left at room temperature for 24 hours after high-pressure steam sterilization at 118 ° C. for 40 minutes, and subjected to the following experiment. Judged.
[0059]
Example 14
The following films were formed using a 5-type 5-layer air-cooled inflation film molding machine. The resin composition of the innermost layer (thickness: 40 μm) is polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density: 0.910 g / cm ^Three , MI = 4) and polyptenic polymer (trade name: buron, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.890 g / cm ^Three , MI = 0.2) was 70:30 by weight. The resin composition of the inner adjacent layer (thickness 30 μm) is modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.890 g / cm). ^Three MI = 5.7). The resin composition of the intermediate layer (thickness 30 μm) is EVOH (trade name: Soarnol, manufactured by Nippon Synthetic Chemical Industry Co., Ltd., ethylene copolymer molar ratio 44%) and styrene elastomer (trade name: Hybler, Kuraray Co., Ltd.). Product, density: 0.940 g / cm ^Three MI = 0.7) was 95: 5 by weight. The resin composition of the outer adjacent layer (thickness 30 μm) is modified polyolefin (trade name: Admer, manufactured by Mitsui Petrochemical Co., Ltd., density 0.890 g / cm ^Three MI = 5.7). The resin composition of the outermost layer (thickness: 30 μm) is polypropylene (trade name: Hipole, manufactured by Mitsui Petrochemical Co., Ltd., density: 0.910 g / cm ^Three MI = 4). The extruder was set at a temperature of 150 ° C. to 220 ° C., a mold temperature of 160 ° C. to 235 ° C., a film take-up speed of 7 to 11 m / min, and a folding diameter of 520 mm. Using this inflation film, a bag (bag) having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was produced so as to have a seal width of 10 mm. In addition, polypropylene (trade name: High Pole, manufactured by Grand Polymer Co., Ltd., density 0.910 g / cm at the opening part) ^Three , MI = 6) and styrene-based elastomer (trade name: Hibler, manufactured by Kuraray Co., Ltd., density: 0.940 g / cm ^Three MI = 0.7) was blended at a weight ratio of 90:10, and the injection-molded port part was heat-sealed. This port is filled with 500 ml of 10 w / v /% amino acid solution (amipalene), left at room temperature for 24 hours after high-pressure steam sterilization at 118 ° C. for 40 minutes, and subjected to the following experiment. Judged.
[0060]
Example 15
A medical container of the present invention having the same configuration as Example 9 and the outermost layer except that the mixed resin of polyethylene and styrene resin was changed to polypropylene was obtained.
[0061]
Example 16
The present invention is the same as in Example 13 except that the innermost layer is composed of a mixed resin of polypropylene and polybutene, and the outermost layer is replaced with polyethylene and polypropylene. A medical container was obtained.
[0062]
[Example 17]
The medical use of the present invention having the same configuration as Example 12 except that the configuration of 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. A container 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: 0.940 g / cm ^Three ), A bag (bag) having an outer dimension of 200 mm in the horizontal direction and 250 mm in the vertical direction was produced by heat sealing (width 10 mm). And density in opening part: 0.945g / cm ^Three Port portions made of polyethylene were thermally welded. A polyethylene cap (density: 0.945 g / cm) filled with 500 ml of 10 w / v /% amino acid solution (amipalene) from the port portion of this bag and fitted with a rubber stopper that passed Japanese Pharmacopoeia (13th revision). ^Three ). This bag was left at room temperature for 24 hours after autoclaving at 121 ° C. for 20 minutes and subjected to the following experiment.
[0064]
[Control Example 2]
Control film 2 [thickness 220 μm: layer structure, polypropylene (density: 0.910 g / cm ^Three ) / Amorphous polypropylene (density: 0.890 g / cm ^Three ) / Adhesive polypropylene (Admer) / EVOH (thickness 30 μm, trade name: Soarnol, manufactured by Nippon Synthetic Chemical Co., Ltd.) / Adhesive polypropylene (Admer) / polypropylene (density: 0.910 g / cm) ^Three ) Was used to produce a bag (bag) having an outer size of 200 mm in the horizontal direction and 250 mm in the vertical direction by heat sealing (width 10 mm). And density in opening part: 0.910 g / cm ^Three Port portions made of polypropylene were thermally welded. A polypropylene cap (density: 0.910 g / cm) filled with 500 ml of 10 w / v /% amino acid solution (amipalene) from the port part of this bag and fitted with a rubber stopper that passed the Japanese Pharmacopoeia (13th revision). ^Three ). 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.
[0065]
1) Delamination after sterilization (number of samples: 100)
[0066]
[Table 1]

[0067]
2) Stability test results (60 ° C. 75% RH, 4 weeks, number of samples = 5)
24 hours after the completion of sterilization, the manufactured sample was stored under conditions (60 ° C. 75% RH) for 4 weeks, and the stability of the content medicine was examined. As for the content, the individual content of amino acids was examined, and even if one kind of content was found to have decreased in content, it was judged as rejected.
[0068]
[Table 2]

[0069]
3) Single item drop
24 hours after the end of sterilization, the various bags produced as described above were stored in a low temperature and high temperature bath BNC-120 (set to 8 ° C) manufactured by Tabai Espec Co., Ltd. for 24 hours, and the product temperature was 10 ° C or less. After confirming this, it was subjected to a drop test. Drop test conditions were dropped from a height of 60 cm.
[0070]
In the evaluation of the single item drop test, the above three points were visually confirmed: (1) the presence or absence of scratches on the bag leading to the pinhole, (2) the presence or absence of abnormalities in the bag and the seal part, and (3) the presence or absence of leakage of the solution in the interior.
[0071]
In addition, all of the control examples 1 and 2 subjected to the test had delamination after sterilization.
[0072]
[Table 3]

[0073]
【The invention's effect】
According to the present invention, a multilayer film medical container having all the quality performances desired for medical use such as transparency, impact resistance, flexibility, gas barrier property, low temperature strength, heat resistance and antifouling property is provided. Can be provided.
[Brief description of the drawings]
FIG. 1 is a plan view of a medical container of the present invention.
FIG. 2 is an enlarged sectional view showing an embodiment of a multilayer film constituting the medical container of the present invention.
FIG. 3 is an enlarged cross-sectional view showing another embodiment.
FIG. 4 is an enlarged sectional view showing still another embodiment.
[Explanation of symbols]
1 middle class
2 Adjacent layers
3 innermost layer
4 outermost layer
5 Adhesive layer

Claims (15)

In medical containers made of multilayer film,
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 be in direct contact with the inner surface side of the intermediate layer,
The inner adjacent layer is composed of a resin having a modified polyolefin as a main component, or a first mixed resin having a modified polyolefin and a styrene resin as main components ,
The inner adjacent layer has a thickness of 30 to 60 μm,
The thickness of the said multilayer film is 160-210 micrometers, The medical container characterized by the above-mentioned .   2. The medical container according to claim 1, wherein the mixed resin constituting the intermediate layer contains at least 50% by weight of ethylene / vinyl alcohol copolymer and at least 5% by weight of styrene resin.   2. The medical container according to claim 1, wherein 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 styrenic resin.   The medical container according to claim 1, wherein an outer adjacent layer is formed on the outer surface side of the intermediate layer.   From the resin whose main component is the modified polyolefin, the first mixed resin whose main component is the modified polyolefin and the styrene resin, or the second mixed resin whose main component is the polypropylene resin and the styrene resin. It is comprised, The medical container of Claim 4 characterized by the above-mentioned.   The medical container according to claim 4, wherein the outer adjacent layer is made of nylon.   7. The innermost layer as a heat seal layer made of a mixed resin mainly composed of a polypropylene resin and a styrene resin is formed on the inner surface side of the inner adjacent layer. A medical container according to 1.   The medical container according to claim 7, wherein the innermost layer contains a thermoplastic resin other than the two components as a third component in addition to the two components.   The medical container according to claim 1, wherein the outermost layer as a protective layer is formed in contact with the outer side of the intermediate layer.   The medical container according to claim 9, wherein the outermost layer is made of a resin mainly composed of polyolefin, and the outermost layer is bonded to the intermediate layer via an adhesive or an adhesive layer.   The medical container according to claim 4, wherein the outermost layer is formed in contact with the outside of the outer adjacent layer.   The medical container according to claim 11, wherein the outermost layer contains a resin component constituting the outer adjacent layer as a main component.   The medical container according to claim 12, wherein the outermost layer is composed of a mixed resin mainly composed of a polypropylene resin and a styrene resin.   14. The medical container according to claim 13, wherein the resin component constituting the outermost layer contains a thermoplastic resin other than these resin components in addition to the resin component.   The medical container according to any one of claims 12 to 14, wherein the outermost layer is integrally formed with the outer adjacent layer by extrusion molding.

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