WO2013005890A1

WO2013005890A1 - Inner packing film for medical intravenous bag

Info

Publication number: WO2013005890A1
Application number: PCT/KR2011/007767
Authority: WO
Inventors: 임용수; 박현아; 김성미
Original assignee: 바프렉스 주식회사
Priority date: 2011-07-07
Filing date: 2011-10-19
Publication date: 2013-01-10
Also published as: KR20130005634A

Abstract

Provided is an inner packing material for a non-PVC-based medical intravenous bag. The inner packing material is constituted of a film including a plurality of layers. The film comprises: an upper end layer formed of a polypropylene-based resin having a heat resistance, the upper end layer being exposed to the outside; an inner surface layer constituting an internal surface layer contacting medicines immersed in an intravenous bag, the inner surface layer being formed by mixing a polyethylene-based resin and/or a polypropylene-based resin having superior heat sealability using a rubber-based resin having flexibility; and a moisture/gas blocking layer configured to block moisture and gas, the moisture/gas blocking layer formed of an ethylene vinyl alcohol (EVOH) resin, a nylon resin, or a nano nylon resin. The upper end layer and the moisture/gas blocking layer, and the moisture/gas blocking layer and the inner surface layer respectively adhere to each other using an adhesion layer as a medium. The inner packing material does not include a secondary pouch for surrounding a packing material thereof.

Description

【Specification】

[Name of invention]

Internal packaging film for medical sap bag

Technical Field

The present invention relates to a medical sap bag pouch, and more particularly to a medical sap bag pouch containing an inner packaging material excellent in moisture barrier properties, oxygen barrier properties, transparency, flexibility and heat resistance.

Background Art

Conventional medical fluid container is made of a glass bottle, there is an inconvenience that must be periodically adjusted the flow rate due to the generation of a vacuum space as the contents of the fragile and easy to use. Therefore, a flexible pouch form that is completely deformable and easily deformed is currently used. Pouches having this advantage allow the fluid to drain from the pouch at approximately constant speed, as the pouch shrinks at a rate proportional to the drainage rate due to atmospheric pressure when the sap is discharged from the pouch. For this property and in consideration of ease of handling, logistics costs, and ease of disposal after use, a light and soft polyvinyl chloride (PVC) -based sap container is widely used. However, due to the plasticizer added to the soft PVC container, there is a problem of environmental hormones during safety controversy and incineration, and a bag-type container using a non-PVC-based coextrusion film has been developed. Non-PVC fluid container is easy to handle soft PVC bags With the advantages of easy disposal and high temperature sterilization, there are no human hazards and environmental problems caused by plasticizers, not only high-temperature seals but also heat-sealing seals. Most preferred. Non-PVC-based film having the above advantages is to be used as a medical sap bag, for ease of handling and easy disposal after use, flexibility for checking whether the contents are contaminated, harmless, sterilization under high temperature sterilization It has to satisfy various physical property requirements such as sex, heat sealability and inner layer toughness. Therefore, for the film that satisfies the above properties, there is a need for a film that is excellent in heat resistance after high temperature sterilization and does not deform in appearance and maintains excellent transparency and flexibility. In addition, a commonly used sap packaging material is used by packaging a secondary pouch having the above characteristics and a secondary pouch having a gas barrier property for long-term storage and capable of supporting high temperature for high temperature sterilization treatment. . However, since the pouch for medical sap bag must be manufactured separately from the primary and secondary pouches, there is a problem that the process is complicated and the cost is increased (for example, see Patent No. 10-812669).

[Detailed Description of the Invention]

[Technical problem]

The present invention is to solve the problems appearing in the prior art, one purpose is to enable high-temperature sterilization of non-PVC-based medical sap bag To provide a non-PVC-based medical sap bag pouch that satisfies the sap bag requirements such as transparency, flexibility, moisture / gas barrier properties.

Another object of the present invention is a non-PVC-based medical sap bag pouch having a property that does not reduce the flexibility while providing moisture / gas barrier properties, instead of the conventional inner bag for moisture / gas barrier To provide a packaging.

Another object of the present invention is to provide a non-PVC-based medical sap bag pouch inner packaging material that can be configured as a pouch of a single structure, rather than a pouch for a medical sap bag.

[Technical solution]

In order to achieve the above object, according to the present invention there is provided a non-PVC-based medical sap bag pouch. The inner packaging material is composed of a film consisting of a plurality of layers of the inner packaging material, the film is made of a polypropylene (polypropylene) resin having heat resistance characteristics and exposed to the outside, and contained in the sap bag The inner layer consists of an inner surface layer in contact with chemicals and blocks the inner layer composed of polyethylene resin and / or polypropylene resin having excellent heat sealing properties and rubber resin which gives flexibility characteristics. It comprises a water / gas barrier layer consisting of ethylene vinyl alcohol (EVOH), nylon or Nano Nylon resin, the top layer and the water / gas barrier layer and the water / gas barrier layer and the inner surface The layers are each bonded to each other via an adhesive layer therebetween, and the inner packaging material is a secondary pouch that wraps the packaging material. One being configured without All. In one embodiment, the top layer may further include a rubber-based resin in addition to the polypropylene resin. In one embodiment, an alpha olefin copolymer or SEBS (Stylene Ethylene / Butadien Stylene) may be used as the rubber-based resin. In one embodiment, nylon may be used as the moisture / gas barrier layer, in which case Nylon6, Nylon6.66 or Nylonll may be used.

【Effects of the Invention】

According to the non-PVC-based medical sap bag pouch of the present invention, while providing moisture / gas barrier properties, the flexibility is not reduced, it is possible to achieve various characteristics required for the sap bag at the same time. In addition, the above characteristics can be provided without providing the secondary pouch, thereby significantly reducing the costs associated with the secondary pouch.

[Brief Description of Drawings]

1 is a view showing a film cross-sectional structure of the inner packaging material for medical sap bag pouch according to an embodiment of the present invention.

[The best form for carrying out invention]

Hereinafter, specific embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the following description, the phrases already well known in the art with respect to the infusion bag preparation Detailed description of the surname is omitted. Even if this description is omitted, those skilled in the art will be able to easily understand the features of the present invention through the following description. The inner packaging material according to the present invention was prepared at 200 ~ 230 ^° C using a bottom-up 5-Layer Blown film machine. The method of manufacturing the film constituting the inner packaging material includes a casting method of forming a cooling roll through T-Die, an inflation method of forming water-cooling through a circular die, and the like, and a method of dry lamination of each film. According to the inventor's observation, when the inflation method is applied, the transparency and flexibility of the film produced is superior to that of the T-Die method or the Lamination method, and it is wound in two layers so that there is no possibility of incorporation of foreign substances in the inner layer. ， Convenience of work convenience. Therefore, in the present invention, a film having excellent flexibility and transparency is manufactured using a water-cooled inflation method. In addition, since the infusion bag is manufactured by forming in the form of a rib, only the upper and lower portions of the infusion bag need to be sealed by post processing. Therefore, when the infusion bag is manufactured by molding into a film, it is possible to reduce the post-processing cost compared to sealing the four sides of the infusion bag. The film cross-sectional structure of the inner packaging material for the medical sap bag pouch manufactured through the process as described above is shown in FIG. As shown in FIG. 1, the inner packaging film according to the present invention is composed of a plurality of layers 10, 20, 30, 40, and 50. The inventors of the present invention consisted of a polypropylene-based resin for heat resistance. According to the example, like the following inner surface layer 50, rubber type resin can also be mix | blended in order to further increase flexibility characteristics. The inner surface layer 50, which is the inner surface layer of the pouch in contact with the chemical contained in the sap bag, is composed of polyethylene and / or polypropylene resin having excellent heat sealing properties, and in order to provide flexibility characteristics System resin, for example, alpha-olefin copolymer was mix | blended and comprised. On the other hand, in relation to the properties that the pouch should have, that is, moisture and oxygen barrier properties, moisture can be obtained using ethylene vinyl alcohol (EVOH), nylon (e.g. Nylon6, Nylon6.66, Nylonll) or nano nylon resin. The gas barrier layer 30 was interposed between the top layer and the inner surface layer, and then, the adhesive layers 20 and 40 were bonded to each other to complete the present invention. Polypropylene generally used is excellent in heat resistance and can withstand high temperature sterilization, but is poor in transparency and flexibility. In order to reinforce this flexibility problem, the film is formed by blending a rubber-based resin in the inner layer 50, and preferably, the rubber-based resin is also blended in the upper layer 10 to further increase flexibility. . As such a rubber-based resin, an alpha olefin copolymer or SEBS (Stylene Ethylene Butadien Stylene) can be used. On the other hand, rubber-based resins increase flexibility, but may also deteriorate heat resistance, so each layer is composed of a compounding ratio that trades off the upper layer. Conventional sap packaging consists of an inner packaging material and a secondary pouch packaging the inner packaging material, that is, two pouches. Resistant packaging material is a direct packaging of the drug, there is a need for flexibility and heat resistance for drainage. However, the packaging material does not have gas / moisture barrier properties, and if stored for a long time, the chemical contained in the packaging material is deteriorated. To prevent this, use a secondary pouch with a gas / moisture barrier. However, since the secondary pouch is to be used, there is a problem in that a separate process for manufacturing the secondary pouch is required and the cost increases accordingly. However, as described above, according to the present invention, in addition to providing a moisture / gas barrier layer to the film constituting the inner packaging material, the rubber-based resin on the inner layer 50 (preferably, the upper layer 10) By including, it is possible to meet all the characteristics required for the sap packaging material, such as flexibility, moisture / gas barrier properties, etc., it is possible to simplify the process and reduce the cost. The present inventors configured various inner packaging materials using the above-described configuration of the present invention, measured the characteristics thereof, and the results are shown in Table 1.

Table 11

Each item in the table is already well known in the art, but briefly described as follows.

Transparency was measured according to ASTM D1003, which indicates the extent to which light is transmitted through the film. Each tensile strength was measured according to ASTM D638, where the tensile strength at break indicates the maximum load that can withstand cracking when the film is pulled, and the yield point tensile strength indicates the force at which permanent deformation begins in the film. Elongation was also measured according to ASTM D638, which indicates the extent to which the film has a stretch property. On the other hand, it is expressed by Modulus value as a measure of the softness of the film. MD and TD are abbreviations for Machine Direction and Transverse Direction, respectively, and indicate the direction in which the film is manufactured. Oxygen permeability was measured according to ASTM D1434 and represents the amount of oxygen permeated per unit area per day. In the comparative example, the top layer was made of homo PP (polypropylene), the middle layer and the inner layer were made of PP and SEBS, that is, composed of 3-layer. In the case of Example 1, the upper layer (10) ol polypropylene (melting point Tm: 145 ~ 165 ^° C), and the inner layer 50 of the polypropylene (melting point 130 ^° C) 10 ~ 90 wt%, Rubber (alpha olefin copolymer or SEBS) was composed of ΚΓ40 wt%, and the bonding between each layer and the barrier layer 30 using an adhesive. In Example 2, the inner layer 50 was composed of 40 to 80 wt% polypropylene, rubber 1 (Γ50 wt% and polyethylene (PE) 530%, and more easy peel characteristics (in sap packaging material) For multichambers, two solutions should be When the mixture is used, the two solutions are separated (heat-bonded), and when a certain force is applied, the heat-bonded portion is peeled off to mix the contents, and the separation property is called an easy peel property). Others were configured similarly to Example 1. As shown in Table 1, it can be seen that in Examples 1 and 2 configured according to the present invention, the characteristics required for the sap packaging material are satisfied. In particular, compared with the comparative example, it can be seen that the oxygen permeability characteristics and the tensile strength characteristics are very excellent. As such, the inner packaging material for the non-PVC-based medical sap bag pouch provided in accordance with the present invention has properties such as flexibility and transparency, and also has moisture / gas barrier properties, and is a single inner packaging material without using a secondary pouch. Only the sap bag can be configured, reducing the cost of materials and processing costs. In addition, because it is processed by the inflation method, it is folded and wound in two layers, there is no possibility of foreign matter mixed in the inner layer, it is hygienic and convenient operation. As mentioned above, although this invention was demonstrated with reference to the preferred embodiment, it is understood that this invention is not limited to the above-mentioned embodiment. That is, the present invention

Various modifications and changes can be made within the scope of the following claims, and all of them fall within the scope of the present invention. Accordingly, the invention is limited only by the claims and the equivalents thereof.

Claims

[Patent Claims]

[Claim 1]

Non—Inner packaging material for PVC-based medical sap bag.

The inner packaging material is composed of a film composed of a plurality of layers,

The film is composed of a polypropylene resin having heat resistance and constitutes an upper layer exposed to the outside and an inner surface layer in contact with a chemical contained in an infusion bag, and has excellent heat sealing properties. ) And / or polypropylene-based resin and rubber-based resins that provide flexibility properties, and act to block moisture and gas, and ethylene vinyl alcohol (EVOH), nylon or nano Includes a moisture / gas barrier layer formed using a nylon nylon resin,

The top layer and the moisture / gas barrier layer and the moisture / gas barrier layer and the inner layer are respectively bonded to each other via an adhesive layer therebetween,

The inner packaging material is a non-PVC-based medical sap bag pouch, characterized in that it is configured without a secondary pouch surrounding the packaging material.

[Claim 2]

The inner packaging material of claim 1, wherein the top layer further comprises a rubber-based resin in addition to the polypropylene-based resin.

[Claim 3]

The alpha-olefin air according to claim 1 or 2 as the rubber-based resin Inner packaging material for Non—PVC-based medical fluid bag pouches characterized by the use of coalescing or SEBS (Stylene Ethylene / Butadien Stylene).

[Claim 4]

The inner packaging material according to claim 3, characterized in that nylon is used as the moisture / gas barrier layer.

[Claim 5]

The inner packaging material according to claim 4, wherein Nylon 6, Nylon 6.66 or Nylonll is used as the nylon.