JP3692516B2 - Resin composition, easily peelable film formed using the same, and flexible container - Google Patents

Description

【００１９】
【表２】

【００２０】
【表３】

【００２１】
実施例サンプルは比較例サンプルに比べて、従来より高温である１２１℃での高圧蒸気滅菌前後でもＴ字剥離強度の変化が小さく、易剥離性が安定していることがわかる。また実施例サンプルが単層フィルムの場合透明性はよくないが、多層フィルムにした場合比較例を上回る優れた透明性を有することが分かる。
【００２２】
【発明の効果】
以上説明してきたことから明らかなように、本発明の樹脂組成物から形成される易剥離性フィルムおよび可撓性容器は、透明性、柔軟性に優れている。また、１１５℃以上の高温での高圧蒸気滅菌処理にも耐えられるため、滅菌時間の短縮が可能であり、滅菌後も安定した剥離性を維持することができる。さらに可塑剤や有害な添加物を含まないポリオレフィン系樹脂からなる樹脂組成物を用いているため、医療安全性に優れており廃棄処理時も有害物質の発生する虞れが少ない。上記の優れた性質は、医薬品等を収容する医療用複室容器として利用する場合特に顕著であるが、その他各種包装材、例えば易劈開性容器や容器の蓋材などへの応用も可能である。
【図面の簡単な説明】
【図１】本発明の樹脂組成物からなる易剥離性フィルムの一実施例を示す断面図である。
【図２】本発明の医療用容器の一実施例を示す正面図である。
【図３】図２に示す医療用容器のＸ−Ｘ線断面図である。
【図４】図３に示す医療用容器の剥離部の拡大断面図である。
【図５】本発明の医療用容器の他の実施例を示す正面図である。
【符号の説明】
１ 易剥離性３層積層フィルム
１１ 易剥離性フィルム層
１２、１３ 基材層
４ 医療用複室容器
４１、４５ 周縁部
４３、５２ 剥離部
４２、４４ 室
５ 医療用容器
５１ 口部[0001]
[Industrial application fields]
The present invention relates to a resin composition excellent in high-pressure steam sterilization resistance, transparency, flexibility, peelability, and the like, and an easily peelable film and a flexible container formed using the composition.
In addition, in this specification, easy peelability is easy by heat-sealing at a relatively low temperature (hereinafter referred to as low-temperature welding) with a strong seal portion that cannot be peeled and opened substantially by heat-welding at a relatively high temperature. The weak seal portion that can be peeled off is a property that can be selectively formed.
[0002]
[Prior art]
Conventionally, a packaging material that can be easily opened by forming a partition wall that can be easily peeled off by low-temperature welding, and a medical multi-chamber container that is partitioned by a partition wall that can be easily peeled are employed.
Medical multi-chamber containers are used for applications such as aseptic mixing of drugs and chemicals that are poorly preserved due to deterioration in the mixed state, just before use. The contents are separately stored in the chamber, and the container is compressed by hand to peel the partition immediately before use, and the contents are aseptically mixed by communicating with a plurality of chambers.
This multi-chamber container firmly seals the side of a single-layer film having easy peelability or a multilayer film laminated so that the film having easy peelability is the innermost layer, and heated gold from the outside of the formed container. A partition wall that can be easily peeled by heat welding with a mold is formed, and the plurality of chambers are liquid-tightly partitioned by the partition wall. In addition, in the case where the multi-chamber container is a container formed of a resin that does not have easy peelability, the easy peelable partition of the multi-chamber container is an easily peelable film (usually a resin used for the film forming the container). And a resin mixture that is incompatible with this resin is employed, and is inserted into the partition wall and thermally welded.
[0003]
Easy-release films used in medical containers must satisfy not only medical safety and disposal but also heat resistance, transparency, flexibility, and impact resistance. Proposals have been made.
For example, JP-A-7-136234 and JP-A-8-131515 disclose an easily peelable film made of a mixture of a polypropylene polymer and an ethylene-α-olefin elastomer on the inner wall surface of a container. JP-A-8-229099 and JP-A-8-229100 disclose a film made of a mixture of a polypropylene polymer or polyethylene polymer, which is a main component, as an inner wall surface of a container, and a styrene elastomer. Has been. However, these films have poor heat resistance of the elastomer component, and change and variation in peel strength of the formed partition walls increase, so that high-pressure steam sterilization can be performed only at 115 ° C. or lower.
On the other hand, Japanese Patent Publication No. 7-96283 discloses an easily peelable film formed from a resin composition of a polyolefin resin and an incompatible resin such as a polymethylpentene resin excellent in heat resistance. When the amount of the incompatible resin is large, the transparency and flexibility are deteriorated and it is inappropriate as a medical material.
[0004]
[Problems to be solved by the invention]
The present invention has been made in view of the above circumstances, and is a resin composition excellent in transparency and flexibility, in which the peel strength of an easily peelable partition wall formed in a higher temperature sterilizing atmosphere does not change, and uses the same An object of the present invention is to provide a flexible film and a flexible container.
[0005]
[Means for Solving the Problems]
As a result of intensive studies, the present inventors have found that a resin composition obtained by mixing 100 parts by weight of resin A, 5 to 80 parts by weight of resin B, and 5 to 15 parts by weight of resin C solves the above problems. .
That is, the present invention is based on 100 parts by weight of the crystalline polyolefin resin (A), 5 to 80 parts by weight of olefin-based and / or styrene-based elastomer (B), polymethylpentene-based resin, and / or ethylene-vinyl alcohol. The present invention relates to a resin composition containing 5 to 15 parts by weight of a polymer (C), an easily peelable film formed using the resin composition, and a flexible container.
[0006]
The resin A in the present invention is preferably a crystalline polypropylene resin or a crystalline polyethylene resin from the viewpoint of chemical resistance and transparency. In order to ensure heat resistance during high-pressure steam sterilization, the Vicat softening point (JIS K7206) Is at least 100 ° C or higher, preferably 110 ° C or higher, more preferably 120 ° C or higher. The crystalline polypropylene resin (PP) described here is a crystalline homopolymer such as isotactic PP or syndiotactic PP, PP partially having an atactic component, or a copolymer based on these. low temperature properties, if the flexural modulus long as emphasis on flexibility (JISK6758) well those 10,000 kg / cm ² or less, preferably 8,000 kg / cm ² or less, more preferably 6,000 kg / cm ² or less It is.
A crystalline polyethylene resin having a density of at least 0.92 g / cm ³ or more, preferably 0.94 g / cm ³ or more, more preferably 0.95 g / cm ³ or more is employed. If it is 0.92 g / cm ³ or less, the heat resistance is poor and sterilization at 115 ° C. or more is difficult.
In addition, if the softening point temperature is 100 ° C. or higher, a cyclic olefin polymer having 5 or more carbon atoms in place of the above-mentioned propylene resin or ethylene resin, or these cyclic olefin monomers and diene monomers or α -Copolymers with olefinic monomers and various derivatives thereof can also be used.
[0007]
As the resin B in the present invention, α-olefin polymers such as butene-1, ethylene-α-olefin copolymers, propylene-α-olefin copolymers, amorphous polypropylene, cyclic olefin copolymers and the like can be employed. These may be composed of the same components as those used in the above-mentioned resin A, but from the viewpoint of imparting flexibility, those having a Shore A hardness (JIS K6301) of 80 or less are preferred, preferably 60 or less, more preferably Is 50 or less.
The styrene elastomer is preferably a flexible elastomer resin having a styrene component of 40 wt% or less. For example, copolymers of styrene and diene monomers such as butadiene and isoprene, hydrogenated polymers in which these unsaturated bonds are saturated by hydrogenation or epoxidation, epoxidized styrene elastomers, and various derivatives thereof is there. Among them, a hydride polymer excellent in non-eluting property, heat resistance, and compatibility with polyolefin resin is preferable.
The ratio of the resin B used for the film of the present invention can be changed depending on the application. In particular, in order to improve flexibility and transparency, it is preferable to blend an amount of 5 to 80 parts by weight with respect to 100 parts by weight of the resin A. When it exceeds 80 parts by weight, the adhesive strength increases, and the blocking phenomenon, heat resistance, and strength decrease between the molded products become remarkable. On the other hand, if it is 5 parts by weight or less, the difference in the peel strength between the partition walls before and after sterilization is large, and the stability is deteriorated.
[0008]
The resin C in the present invention is incompatible with both of the resins A and B, and can be easily peelable by blending. Furthermore, since it has a high melting point and excellent heat resistance compared to other components, it is possible to stabilize the peel strength after high-pressure steam sterilization. In the case of a polymethylpentene resin, a poly-4-methylpentene-1 homopolymer or copolymer can be employed. However, in view of flexibility and kneadability with other resins to be blended, ethylene and other α- More preferred are copolymers with olefins.
The ethylene-vinyl alcohol copolymer changes its melting point, hygroscopicity, sterilization resistance, and compatibility with polyolefin resin depending on the ratio of the vinyl alcohol component, so it is adjusted according to the type of polyolefin resin used as the matrix. There is a need to. In general, those having a vinyl alcohol component of 32 to 47 mol% can be employed.
The ratio of the resin C used in the film of the present invention is preferably 5 to 15 parts by weight with respect to 100 parts by weight of the resin A. If the amount is less than 5 parts by weight, easy peelability is hardly stabilized by sterilization at 115 ° C. or higher, and if it is more than 15 parts by weight, the transparency and flexibility are significantly deteriorated.
These resins A, B, and C may be used one by one, or two or more resins may be mixed and used. However, the molecular weight of the resin in the case of mixing needs to be adjusted according to the processing method and molding conditions of the molded body. Further, various organic and inorganic additives such as anti-blocking agents and flexibility-imparting agents may be used depending on applications, physical properties, molding methods, and processing conditions.
[0009]
DETAILED DESCRIPTION OF THE INVENTION
Next, embodiments of the present invention will be described with reference to the drawings.
FIG. 1 is a view showing one example (having a three-layer structure) of an easily peelable film made of the resin composition of the present invention. 2 is a plan view (consisting of the film shown in FIG. 1) showing an embodiment of the flexible container of the present invention, FIG. 3 is a sectional view taken along line XX of FIG. 2, and FIG. 4 is a partition wall portion shown in FIG. FIG. FIG. 5 is a view showing another embodiment of the flexible container of the present invention.
[0010]
The easily peelable film forming the container of the present invention may be a single layer, but may be a laminated film of the easily peelable film 11 and other resins 12 and 13 as shown in FIG.
In particular, since transparency and flexibility are important for an infusion container and the like, it is preferable to use a laminated film having an easily peelable film 11 as thin as possible as an inner wall layer. In this case, the layer thickness is preferably 70 μm or less, and more preferably 50 μm or less.
In the case of a multilayer film, the resin for the base material layers 12 and 13 includes polypropylene resin, polyethylene resin, ethylene-α-olefin resin, α-olefin resin such as polybutene, cyclic polyolefin resin, and ethylene-vinyl alcohol. In addition to polyolefin resins such as polymers and ethylene-vinyl acetate copolymers, thermoplastic resins such as polyamide resins and polyester resins and blends thereof are employed. In view of medical safety and disposability, polyolefin resin is preferable.
[0011]
The easily peelable film 11 of the present invention can be produced by a method similar to a molding method used for general thermoplastic resins such as T-die molding and inflation molding. In the case of a multilayer molded product, it can be manufactured by insert molding, two-color molding, or the like. Moreover, although a flexible container can be produced from an easily peelable film, it can also be manufactured by methods, such as blow molding and vacuum forming.
[0012]
The multi-chamber container shown in FIG. 2 is made from a tube of a three-layer film as shown in FIG. The container 4 is formed with partition walls 43 that can be easily peeled and edge portions 41 and 45 that are firmly sealed by changing conditions such as temperature, pressure, and time of heat welding. In the figure, reference numerals 42 and 44 denote chambers for storing chemical solutions and drugs.
In order to form the easily peelable partition wall 43, it is preferable to perform heat welding at a temperature equal to or higher than the softening temperature of the resin B having a relatively low melting point and lower than the melting point of the resin C having a relatively high melting point. . T-peeling strength (measured using an Instron universal testing machine, etc., using a strip-shaped test piece bonded together with a peel angle of 180 °) is 0 by heat welding under these conditions. A partition wall 43 of 1 to 1.0 kg / 15 mm (tensile speed 300 mm / min) is obtained. In the case of the multi-chamber container 4, if heat-sealing to such a T-shaped peel strength, the container can be compressed by hand, the partition wall 43 can be peeled, and the chambers 42 and 44 can be communicated. The T-shaped peel strength is preferably 0.1 to 0.8 kg / 15 mm, and more preferably 0.2 to 0.6 kg / 15 mm.
On the other hand, in order to form the tightly sealed edges 41 and 45 of the container, it is preferable to perform heat welding at a temperature equal to or higher than the melting point of the resin A as the main component. Conditions such as the temperature, pressure, and time of heat welding need to be appropriately selected depending on the molding method, the thickness of the partition wall 43 portion, and the shape such as single layer or multilayer.
[0013]
The thus-prepared flexible container, for example, the infusion bag 4, is sterilized by autoclaving after putting the medicine in the chambers 42 and 44, but the conventional container can only withstand a sterilization temperature of 115 ° C. Compared to the case where the container was not sterilized, even if the container of the present invention was sterilized at a temperature of 115 ° C. or higher, the peelability and transparency were not changed, and the sterilization time could be shortened.
[0014]
The easily peelable film 11 of the present invention can be easily peeled off by inserting it into a partition forming part of a flexible single-chamber container formed from a film having no easily peelable film and heat-welding from the outside of the container. Can be formed, and can also be used as a weak adhesive tape.
In addition to the multi-chamber container 4 as shown in FIG. 4, the film of the present invention can be used for a container 5 provided with a partition wall 52 as shown in FIG. It can also be used for films.
[0015]
Hereinafter, the present invention will be described in detail with reference to examples, but the present invention is not limited to these examples.
[0016]
[Examples 1-7]
Each of the resin compositions (compositions 1 to 4) shown in Table 1 was used to form a laminated film having a thickness of 200 μm and a width of 200 mm as shown in Table 2 using a single-layer or three-type / three-layer T-die coextrusion film forming machine. When these films were eluate tested based on the polyethylene or polypropylene aqueous injection container standards according to the Japanese Pharmacopoeia plastic drug container test method , all films were sufficiently safe for medical use. Confirmed to have. Next, the two obtained films were stacked so that the layer of the easily peelable film became the inner wall surface, and heat-welded at a temperature of 130 to 165 ° C. and a pressure of 5.0 kg / cm ² for 10 seconds, and a film sample having a width of 15 mm Was made. This was subjected to high-pressure steam sterilization for 30 minutes at a temperature of 121 ° C. and a pressure of 1.5 kg / cm ² , and 180 ° T-peeling was performed at a speed of 300 mm / min using a tensile tester (AG-500D, manufactured by Shimadzu Corporation). The strength was measured. The results are shown in Table 3. Regarding the transparency of multilayer film samples, after high-pressure steam sterilization, 450 nm light transmission in water using a spectrophotometer (U-3210, manufactured by Hitachi, Ltd.) based on the Japanese Pharmacopoeia plastic drug container test method. The rate was measured. The results are shown in Table 3.
[0017]
[Comparative Examples 1-3]
Each of the resin compositions shown in Table 1 (Compositions 5 to 7) was formed into a laminated film having a thickness of 200 μm and a width of 200 mm as shown in Table 2 using a three-type three-layer T-die coextrusion film forming machine. As in the examples, T-peel strength and light transmittance were measured. The results are shown in Table 3.
[0018]
[Table 1]

[0019]
[Table 2]

[0020]
[Table 3]

[0021]
It can be seen that the change in the T-peel strength is small and the easy peelability is stable before and after the high-pressure steam sterilization at 121 ° C., which is higher than the conventional sample. Moreover, when an Example sample is a single layer film, transparency is not good, but when a multilayer film is used, it turns out that it has the outstanding transparency which exceeds a comparative example.
[0022]
【The invention's effect】
As is apparent from the above description, the easily peelable film and flexible container formed from the resin composition of the present invention are excellent in transparency and flexibility. In addition, since it can withstand high-pressure steam sterilization at a high temperature of 115 ° C. or higher, the sterilization time can be shortened, and stable releasability can be maintained even after sterilization. Furthermore, since a resin composition comprising a polyolefin-based resin that does not contain a plasticizer or harmful additives is used, it is excellent in medical safety and has a low possibility of generating harmful substances during disposal. The above-mentioned excellent properties are particularly noticeable when used as a medical multi-chamber container for storing pharmaceuticals etc., but can also be applied to other various packaging materials such as easy-cleavage containers and container lids. .
[Brief description of the drawings]
FIG. 1 is a cross-sectional view showing an example of an easily peelable film made of the resin composition of the present invention.
FIG. 2 is a front view showing an embodiment of the medical container of the present invention.
3 is a cross-sectional view of the medical container shown in FIG. 2 taken along line XX.
4 is an enlarged cross-sectional view of a peeling portion of the medical container shown in FIG.
FIG. 5 is a front view showing another embodiment of the medical container of the present invention.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 Easy peelable 3 layer laminated film 11 Easy peelable film layer 12, 13 Base material layer 4 Medical multi-chamber container 41, 45 Peripheral part 43, 52 Peel part 42, 44 Chamber 5 Medical container 51 Mouth

Claims (5)

Olefin elastomer and / or styrene elastomer (B) 5 to 80 parts by weight, polymethylpentene resin and / or ethylene-vinyl alcohol copolymer (C) with respect to 100 parts by weight of crystalline polyolefin resin (A) ) A flexible container formed of a resin composition comprising 5 to 15 parts by weight, and a multi-chamber container having a plurality of chambers liquid-tightly partitioned by an easily peelable partition wall Flexible container. Flexible container of claim 1, wherein formed by cold welding an inner wall partition walls facing the container. Claim 1 or 2 flexible container, wherein the infusion bag. Olefin elastomer and / or styrene elastomer (B) 5 to 80 parts by weight, polymethylpentene resin and / or ethylene-vinyl alcohol copolymer (C) with respect to 100 parts by weight of crystalline polyolefin resin (A) ) A flexible container formed of a resin composition comprising 5 to 15 parts by weight, wherein the container mouth is liquid-tightly closed by a partition wall that can be easily peeled off. The flexible container according to claim 4, wherein the partition wall is formed by low-temperature welding of the inner wall facing the container mouth portion.

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