JP2906487B2 - Medical article transparent package - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Application Field] The present invention is to package a plastic container containing a drug solution such as an amino acid preparation, a glucose preparation, and a fat emulsion, and protect the container from gas such as oxygen. The present invention relates to a transparent package for medical articles for long-term stable storage of a drug solution in a container.

[Conventional technology]

Conventionally, drug solutions such as amino acid preparations, glucose preparations, and fat emulsions have been provided in flexible plastic containers, which have been sterilized in an autoclave. However, these chemicals are easily degraded by gas, especially oxygen,
There has been a problem that oxygen passes through the container wall over time, dissolves in the chemical solution, and deteriorates the chemical solution.

For this reason, a plastic container for accommodating a chemical is packaged with a packaging material having high gas barrier properties (particularly, oxygen barrier properties). However, a plastic film coated with vinylidene chloride as a conventional gas barrier packaging material (mainly stretched polyethylene,
Stretched polyamide, stretched polypropylene coated with vinylidene chloride), laminated film using polyethylene / polyvinyl alcohol copolymer, laminated film using aluminum foil, etc. There are drawbacks such as:

Autoclave sterilization of the laminate film coated with vinylidene chloride reduces gas barrier properties,
It is not suitable for packaging a plastic container containing a chemical solution with the laminate film and sterilizing it in an autoclave, because the transparency is lowered. Also, a laminated film using a polyethylene / polyvinyl alcohol copolymer film is unsuitable for performing autoclave sterilization after packaging a plastic container containing a chemical liquid with the laminated film because the gas barrier property is significantly reduced under high humidity. .

On the other hand, after autoclave sterilization, even if a drug is packaged using such a film having a high gas barrier property, deterioration of the contents due to oxygen over time has not been completely prevented.

Further, as a method for solving such a phenomenon, an aluminum foil (usually 7 to 20 μm thick) laminate film is used, but there is a problem that the quality of the chemical solution is deteriorated and other changes cannot be easily confirmed. Is not suitable.

[Problems to be solved by the invention]

As described above, at present, even if medical articles containing liquids, particularly chemicals, are packaged in packages having high gas barrier properties, autoclave sterilization is performed to achieve the original strength and gas barrier properties of the packages, that is, the overlap material. It is difficult to satisfy all of the transparency at the same time.

Further, as a method for overcoming the above-mentioned problem of packaging, "Retort pouch for infusion solution" (Japanese Utility Model Laid-Open No. 1-98640) is provided. The retort pouch is, as described in the claims, a sheet formed by laminating a polyester resin layer, a silica-deposited layer and a linear low-density polyethylene layer or a linear medium-density polyethylene layer in this order. The sheet is formed in a bag shape with the polyester resin layer of the sheet facing outward.

However, in this retort pouch, cracks and the like are generated in the vapor deposition layer due to torsional impact, pinholes are easily generated, silica vapor deposition stability is poor, thereby causing variations in gas barrier properties, and quality control of formed bags. A difficult problem remains. Therefore, this leads to an increase in cost, and furthermore, the sheet has poor heat resistance, and thus is not suitable for a drug to be subjected to autoclave sterilization.

Therefore, an object of the present invention is to solve the problems seen in the retort pouch for an infusion agent disclosed in the above-mentioned publication in view of the above points, and to achieve a long-term stable storage of a drug solution in a container having a significantly higher gas barrier property. An object of the present invention is to provide an optimal medical article transparent package.

[Means for solving the problem]

The object is an unstretched film whose innermost layer is made of a polyolefin resin having a density of 0.89 to 0.965, a biaxially stretched film whose intermediate layer is made of a vinylidene chloride-acrylate copolymer, and an aluminum oxide whose outermost layer is made of polyethylene terephthalate. This is achieved by a medical article transparent package, which is a vapor-deposited film and is laminated in the order of an innermost layer, an intermediate layer, and an outermost layer.

That is, the package of the present invention is formed by sequentially laminating the three layers of the innermost layer, the intermediate layer, and the outermost layer made of the specific material.

Thus, the innermost layer has heat resistance (to the extent that it is not deformed) that can withstand heat during autoclave sterilization, and has heat sealing properties due to heat sealing. The innermost layer preferably has good moisture permeability. In a polyolefin resin having such properties, 110
For those subjected to autoclave sterilization below ℃, the density
0.90 ~ 0.93 linear low density polyethylene is good, 115 ℃
The density of the autoclave sterilized above is 0.
89-0.91 polypropylene is preferred. The film made of the polyolefin resin is not stretched.

The intermediate layer preferably has good gas (especially, oxygen) barrier properties and excellent moisture resistance, transparency, and heat resistance (autoclave suitability). As the vinylidene chloride / acrylic acid ester-based copolymer constituting the intermediate layer, for example, Saran-UB manufactured by Asahi Kasei Kogyo Co., Ltd. is optimal. The intermediate layer film is biaxially stretched.

The outermost layer is a part which is most susceptible to heat during autoclave sterilization, and needs to have a higher melting point than the innermost layer and the intermediate layer. The outermost layer preferably has good gas barrier properties and good moisture permeability. The outermost layer is made of polyethylene terephthalate (PET), and is formed by depositing aluminum oxide on a PET film. Aluminum deposition may be performed by a method known per se, and the thickness of the deposited film is 200 to 1000 Å, preferably 500 to 80.
It is about 0Å.

The thickness of each layer depends on the medical article to be packed, but the unstretched film of the innermost layer is 20 to 80 μm, preferably 40 to 60 μm.
m, the biaxially stretched film of the intermediate layer is 15 to 25 μm, the PET film of the outermost layer is 10 to 25 μm, and the deposited aluminum oxide film on the PET film is as described above.

There is no particular limitation on the method of forming a film made of the constituent material of each of the above-mentioned layers. In particular, biaxial stretching and vapor deposition of aluminum oxide may be performed by a usual method.

In addition, the film of each layer is adhered with an appropriate adhesive,
The adhesive to be used is not particularly limited, but the adhesive to be used needs to have heat resistance enough to withstand autoclave sterilization and strength enough to firmly bond each layer, and a polyurethane-based adhesive (for example, Takeda Pharmaceutical Co., Ltd.) Bamboo rack A-
310, AD-527 manufactured by Toyo Morton Co., Ltd.).

〔Example〕

Hereinafter, the medical article transparent package of the present invention will be described in detail based on examples.

FIG. 1 shows a plastic container 20 filled with a drug solution such as an amino acid preparation, a glucose preparation, and a fat emulsion, which is packaged by the transparent package 10 of the present invention.

An embodiment of such a transparent package 10 is shown in FIG. This package is a PET film in which the innermost layer is a CPP (unstretched polypropylene) film 1, the intermediate layer is a biaxially stretched vinylidene chloride / acrylate copolymer copolymer film 3, and the outermost layer is an aluminum oxide deposited film 6. 5. Innermost layer 1 and middle layer 3, middle layer 3 and outermost layer deposited film 6
Are bonded by adhesives 8 and 9, respectively.

Next, an example of manufacturing a package having the structure shown in FIG. 2 will be specifically described.

A transparent high-barrier film (outermost layer 5, 6: for example, PET deposited product type 1011 manufactured by Toyo Metallizing Co., Ltd.) in which aluminum oxide (mainly Al ₂ O ₃ ) is vapor-deposited on a PET film having a thickness of 12 μm by 500 to 600 °, A polyurethane-based adhesive (corresponding to the adhesive 9: Takelac A-310 manufactured by Takeda Pharmaceutical Co., Ltd.) was applied in an amount of 4 to 5 g / m ² (application amount at the time of drying), and this was applied to a drying oven (about 10 m in length). (Temperature of about 80 ° C) to dry the adhesive solvent.

Next, similarly, as a transparent high barrier film of the intermediate layer 3, a biaxially stretched film of vinylidene chloride / acrylate copolymer having a thickness of 15 μm (for example, Asahi Kasei Corporation)
Saran-UB: specific gravity 1.76 to 1.78) is overlaid on the polyurethane-based adhesive surface, and this is pressed and laminated with a metal roll and a rubber roll heated to 60 to 80 ° C (lamination speed: about
60 m / min) and further pass through a cooling roll and take up in a roll shape. The rolled material is left in a room at about 40 ° C. for 2 days, and is aged to accelerate the reaction of the adhesive.

Next, a 30 μm thick CPP film (for example, Pyrene film manufactured by Toyobo Co., Ltd.—CTP-1128: specific gravity 0.89 to 0.91) as the innermost layer 1 is coated with a polyurethane adhesive (corresponding to adhesive 8) as described above. 4 to 5 g / m ² (coating amount when dry)
The adhesive is applied and passed through a drying furnace (temperature: about 80 ° C.) with a total length of about 10 m to dry and evaporate the solvent of the adhesive.

Next, the biaxially stretched PET film (the outermost layers 5 and 6), the biaxially stretched film of the vinylidene chloride-acrylate copolymer biaxially stretched film (intermediate layer 3), and the CPP film (the outermost layer). The surface of the adhesive applied to the inner layer 1) is overlapped, and this is pressed and laminated with a metal roll and a rubber roll heated to 60 to 80 ° C (lamination speed:
About 60 m / min), and further pass through a cooling roll and take up in a roll form. Finally, the rolled material is left in a room at about 40 ° C. for 2 days to age the adhesive.

EXAMPLES Hereinafter, it is clarified by an experimental example that the package of the present invention is excellent in impact resistance, transparency, and gas barrier properties.

Prepare a package composed of the outermost layer, intermediate layer, and innermost layer as shown in Tables I and II, and perform oxygen permeability, moisture permeability and transparency tests I and II under the following test conditions. Are shown in Tables I and II, respectively.

[Test I]

The oxygen permeability, moisture permeability and transparency of each package film were measured by the following test methods. The results are shown in Table I.

(Oxygen permeability test) It was measured according to ASTM D3985-81.

(Moisture Permeability Test) Measured according to JIS Z0208.

(Transparency test / haze) Measured according to JIS K7105.

(Test II)

High-pressure steam sterilization of each package film (autoclave: 1
The oxygen permeability, moisture permeability and transparency before and after (21 ° C. × 20 minutes) were measured by the above test method. The results are shown in Table II.

[Effect of the Invention] As described above, the medical article transparent package of the present invention is composed of the innermost layer, the intermediate layer, and the outermost layer, and each layer is made of a specific material, and thus has heat resistance enough to withstand autoclave sterilization. In addition, it has high gas barrier properties (especially oxygen barrier properties) and moisture resistance, and is optimal for long-term stable storage of chemicals.

In addition, because of its good transparency, changes in the contents can be easily confirmed, so that it is suitable as a medical product package.

The package of the present invention may be used as an overlap packaging material after autoclaving a container containing a drug solution, and the drug solution stability during storage of the product is good.

[Brief description of the drawings]

FIG. 1 is a plan view when a medical article is packaged by the package of the present invention, and FIG. 2 is a partially omitted sectional view showing one embodiment of the package of the present invention. 1: Unstretched film (innermost layer) 3: Biaxially stretched film (intermediate layer) 5: Aluminum oxide deposited film (outermost layer) 6: PET film (outermost layer) 8, 9: Adhesive

──────────────────────────────────────────────────続 き Continued on front page (58) Field surveyed (Int. Cl. ⁶ , DB name) B32B 1/00-35/00

Claims (4)

(57) [Claims] 1. A transparent package for packaging a container filled with a liquid, wherein the innermost layer is a film made of a polyolefin resin, and the intermediate layer is a film made of a vinylidene chloride-acrylate copolymer resin. A transparent packaging for medical articles, wherein the outermost layer is an aluminum oxide deposited film made of a resin having a higher melting point than the resin of the innermost layer and the intermediate layer, and is laminated in the order of the innermost layer, the intermediate layer and the outermost layer body. 2. An unstretched film in which the innermost layer is made of a polyolefin resin having a density of 0.89 to 0.965, an intermediate layer is a biaxially stretched film made of a vinylidene chloride / acrylate copolymer, and an outermost layer is an oxidation film made of polyethylene terephthalate. The medical article transparent package according to claim 1, which is an aluminum vapor-deposited film. 3. The method according to claim 2, wherein the innermost layer is an unstretched film made of polypropylene having a density of 0.89 to 0.91 or an unstretched film made of linear low-density polyethylene having a density of 0.90 to 0.93. Transparent package for medical articles. 4. The medical article transparent package according to claim 1, wherein the haze value is 15% or less.