JPH031021B2 - - Google Patents

Description

[Detailed description of the invention]

[Industrial Application Field] The present invention relates to a medical article package and a packaging material. [Prior Art] Conventionally, medicinal solutions such as amino acid preparations, fat emulsions, and vitamin preparations have been stored in flexible plastic containers and sterilized by autoclaving. However, these chemical liquids are easily deteriorated by oxygen, and there is a problem in that during sterilization or storage, the chemical liquid passes through the container wall and is deteriorated by the oxygen dissolved in the chemical liquid. Therefore, plastic containers containing the above-mentioned chemical solutions are now being packaged with packaging materials having high gas barrier properties. However, conventionally used gas barrier packaging materials have low heat resistance and are deformed by heat during sterilization. Therefore, double packaging is performed in which the container is first wrapped in a heat-resistant packaging material, then sterilized in an autoclave, and then wrapped again in a gas barrier packaging material. However, as mentioned above, gas barrier packaging materials not only have poor heat resistance, but also
It also has poor impact resistance, and pinholes are likely to form due to impact during transportation, and oxygen can enter through these pinholes.
There is a problem of deteriorating the chemical liquid. [Problems to be Solved by the Invention] As seen above, conventionally, even if medical articles containing liquids, especially medical solutions, are double-packaged, the heat resistance, gas barrier properties, and impact resistance during autoclaim sterilization are insufficient. It is not possible to satisfy all sexual needs at the same time. Therefore, the present invention provides heat resistance, gas barrier properties, and
It is an object of the present invention to provide a medical article packaging body and packaging material that can simultaneously satisfy the requirements of impact resistance and impact resistance. [Means for Solving the Problems] In the present invention, as a packaging body or packaging material for packaging a medical article containing a liquid, particularly a medical solution,
Inner layer with heat resistance and heat sealability, 121℃
It consists of a laminate consisting of an intermediate layer made of an aromatic polyamide resin with a heat shrinkage rate of less than 4%, and an outer layer having a higher melting point than the inner layer, and has an average shrinkage of 4.8 cc/m ² after autoclave sterilization. Atmospheric pressure/
A material with an oxygen permeability of 20°C and 65% relative humidity or less is used. The outer layer is made of polyester film coated with vinylidene chloride resin, the intermediate layer is made of biaxially stretched aromatic nylon film, and the inner layer is made of unstretched polypropylene film. [Example] Hereinafter, the present invention will be described in more detail with reference to the accompanying drawings. As shown in FIG. 1, a medical article containing a liquid, particularly a plastic container 11 containing a drug solution 13, is
It is packaged in a package 14 made of the packaging material of this invention. The container 11 is made of a flexible plastic such as polyvinyl chloride resin or crosslinked ethylene-vinyl acetate copolymer. A port 12 communicating with the inside of the container 11 is provided at one end of the container 11, and a drug solution 13 containing components that are easily degraded by oxygen, particularly a high concentration (10 to 12% by weight) containing tryptophan, is provided at one end of the container 11.
Amino acid infusions, fat emulsions, vitamin preparations, etc. are introduced into the container 11 through the port 12. After introducing the chemical solution 13 into the container 11, the port 12 is sealed with a suitable sealing member by high frequency welding or the like. A plastic container 11 containing a drug solution is a packaging body 1.
4. It is preferable that the product is vacuum packaged. By vacuum packaging, the amount of oxygen present between the package 14 and the container 11 can be minimized, oxygen can be prevented from entering the chemical solution 13, and almost no air phase is present. As a result, thermal conductivity is improved and autoclave sterilization can be performed more efficiently. The packaging body 14 for packaging the plastic container 11 containing the drug solution is preferably transparent so that the state of the drug solution can be visually observed, and as shown in FIG. Consists of a laminate. The inner layer 21 has heat resistance (does not deform) to withstand the heat during autoclave sterilization, which will be described later, and has heat sealability since it is heat sealed. In addition, this inner layer 21
It is preferable that the material also has good moisture permeability. As the plastic material constituting such inner layer 21, unstretched polypropylene is particularly preferred. High-density polyethylene is also considered as the inner layer material, but it has a problem with transparency. In addition, the inner layer 21 is 60~
Preferably it has a thickness of 80 μm. The intermediate layer 22 has a heat shrinkage rate at 121°C (121°C
x30 minutes in saturated steam) is less than 4% biaxially oriented aromatic nylon film. Heat shrinkage rate is 4
%, the inner layer 21 and outer layer 23 will peel or wrinkle. Transparency also decreases. This intermediate layer 22 preferably has good gas (particularly oxygen gas) barrier properties, as well as excellent mechanical strength and moisture permeability. As the material constituting the intermediate layer 22, a biaxially stretched nylon film is particularly preferred. In addition to biaxially oriented aromatic nylon film, there are other materials with excellent gas barrier properties, such as vinylidene chloride resin and saponified ethylene-vinyl acetate copolymer, but they have poor heat resistance and water resistance, so they are not used as the intermediate layer 22. is inappropriate. In addition,
Preferably, the intermediate layer 22 has a thickness of 10 to 20 μm. The outer layer 23 is the part most susceptible to heat during autoclave sterilization, and needs to have a higher melting point than the inner layer 21. In addition, the outer layer 23
Desirably, the material also has good gas barrier properties and moisture permeability. The plastic material constituting the outer layer 23 is a vinylidene chloride resin coated on the inner surface to a thickness of 1 to 3 μm (so-called K
Coated polyester films are particularly preferred. Note that the outer layer 23 preferably has a thickness of 7 to 17 μm. The inner layers of the package 14 are heat-sealed together at the peripheral edge 14a (FIG. 1). In this way, the plastic container 11 containing the drug solution packaged in the package 14 is autoclaved in an atmosphere of saturated steam substantially free of oxygen while being packaged in the package 14. High pressure steam sterilization (autoclave sterilization) is usually performed at 121℃.
It is performed for 20 to 30 minutes. At this time, the package 1
In No. 4, there is almost no decrease in transparency, and there is also little decrease in gas barrier properties. Even after such autoclave sterilization, the package 14 is JIS compliant.
According to the standard, the overall average is 4.8cc/ ^m2・atmospheric pressure・24 hours・
Atmospheric pressure, 20℃, 65% relative humidity or less, preferably 3.0
cc/ ^m2 , 24 hours, atmospheric pressure, 20℃, 65% relative humidity or less, preferably 2.5cc/ ^m2 , 24 hours, atmospheric pressure, 20
It has an oxygen permeability of less than 65% relative humidity at °C. Below, vibration tests, coloring level tests, head space oxygen concentration tests, dissolved oxygen concentration tests, drug solution PH tests,
The results of the tryptophan content test are shown together with those of comparative examples. Vibration Test Plastic containers containing amino acid preparations containing tryptophan as medicinal solutions were each packaged with packaging materials having the following configurations. Invention: Inner layer: unstretched polypropylene film with a thickness of 70 μm Intermediate layer: biaxially stretched nylon film with a thickness of 15 μm Outer layer: polyester film with a thickness of 12 μm coated with K (1 to 3 μm) Comparative example: Inner layer: Thickness 60 μm polyethylene film Middle layer: 15 μm thick polyvinylidene chloride film Outer layer: 15 μm thick nylon film Each of the above samples was tested using a packaging cargo vibration tester according to JISZ0232.
Based on the vibration test method, a 5G x 1 hour vibration test was conducted to observe the occurrence of pinholes in the packaging material. Table 1 below shows the number of samples in which pinholes occurred for each 20 samples.

[Table] From this result, it can be seen that the packaging material of the present invention does not generate pinholes even in severe vibration tests. Coloring level test, headspace oxygen concentration test, dissolved oxygen concentration test, chemical solution PH test, tryptophan content test The product of the present invention in the above vibration test was subjected to high-pressure steam sterilization at 121°C for 30 minutes, and then sterilized in a constant temperature bath at 60°C. After 0 days, 4 days, 8 days, 17 days, and 30 days, the coloring level (transmittance T% at a wavelength of 420 nm was measured), the head space oxygen concentration (the oxygen concentration in the head space was measured using an oxygen analyzer) The pH of the drug solution (amino acid preparation) (measured with a PH meter), and the tryptophan content in the amino acid preparation (measured with an amino acid analyzer) were measured. For comparison, a similar Splastic container containing an amino acid preparation was wrapped in polypropylene film and subjected to the same high-pressure steam sterilization, and then a similar test was conducted on a container packaged with the packaging material of the comparative example used in the vibration test. . The results are shown in FIGS. 3 to 7, respectively. In FIGS. 3 to 7, line a is for the present invention, and line b is for the comparative example. From these results, it can be seen that the products of the present invention are equivalent to or better than the comparative examples in the accelerated coloring level test, headspace oxygen concentration test, dissolved oxygen concentration test, chemical solution PH test, and tryptophan content test. Oxygen permeability and moisture permeability test The oxygen permeability and moisture permeability of the packaging material used for the product of the present invention in the vibration test above were measured before and after high-pressure steam sterilization (121°C x 30 minutes) according to ASTM D3985-81. The results are shown in Table 2 below.

[Table] [Effects of the Invention] As described above, according to the present invention, there is provided a medical article package that is single-packed, has heat resistance that can withstand autoclave sterilization, and has excellent impact resistance and gas barrier properties. and packaging materials are provided.

[Brief explanation of the drawing]

FIG. 1 is a plan view showing a medical article package of the present invention, FIG. 2 is a sectional view of the packaging material of the present invention, and FIGS. 3 to 7 are views of the medical article package of the present invention. Graph diagram showing characteristics together with comparative examples. 11...Plastic container, 13...Medicinal solution,
14... Packaging body, 21... Inner layer, 22... Intermediate layer, 23... Outer layer.

Claims (1)

[Scope of Claims] 1. A medical article package comprising a medical article containing a liquid and a package made of a transparent flexible material for packaging the medical article, wherein the package is heat-resistant. an inner layer made of an unstretched polypropylene film having heat-sealing properties, an intermediate layer made of a biaxially oriented aromatic nylon film having a heat shrinkage rate of less than 4% at 121°C, and a melting point higher than that of the inner layer. It is made of a laminate with an outer layer made of polyester film coated with vinylidene chloride resin, and has an average resistance of 3.0 after autoclave sterilization.
A medical article packaging body characterized by having an oxygen permeability of cc/m ² / 24 hours / atmospheric pressure / 20°C / 65% relative humidity or less. 2. The medical article package according to claim 1, wherein the medical article is a plastic container containing a vitamin preparation, a fat emulsion, or an amino acid preparation. 3. The medical article package according to claim 1 or 2, wherein the medical article is vacuum packaged within the package. 4. Packaging materials for packaging medical articles containing liquids, including an inner layer made of an unstretched polypropylene film that is heat resistant and has heat sealability, and a biaxial material with a heat shrinkage rate of less than 4% at 121°C. It consists of a laminate consisting of an intermediate layer made of a stretched aromatic nylon film and an outer layer made of a polyester film coated with vinylidene chloride resin, which has a higher melting point than the inner layer, and has an average of 3.0 cc/m ² after autoclave sterilization.・24 hours・Atmospheric pressure・20
A packaging material characterized by having an oxygen permeability of 65% relative humidity or less at °C.