JPS5917349A - Medical package container - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention]

(9) Cost Technical Field of the Invention The present invention relates to a medical packaging container. To be more specific, the present invention is intended to contain the odor that occurs especially when medical tools and the like are sterilized by radiation into a packaging container that is substantially odorless upon opening. Prior Art Conventionally, disposable injection needles, disposable syringes, disposable bare-face 4-knit fabrics, suture threads, medical non-woven fabrics, etc. have been sterilized with a sterilizing agent such as ethylene oxide → noid gas, and then similarly sterilized with 91i embedding. However, due to the toxicity of the 21-dilene A:1 side gas to the human body, it cannot be ignored. There is. As a sterilization method that does not use such toxic sterilizing agents, a radiation sterilization method has recently been proposed. In the radiation sterilization method, medical tools are placed in a packaging container and then irradiated with radiation. However, since radiation irradiation has negative effects such as deterioration, coloring, and soot on packaging containers, materials for packaging containers should be selected from materials that have minimal negative effects. At present, packaging containers for radiation sterilization of the above-mentioned medical devices include films such as polyethylene terephthalate and polypropylene. A bag-shaped composite film is used, in which a film layer of a low melting point resin such as polyT-dylene or ethylene-vinyl acetate copolymer is laminated on the inner surface of a thermoplastic resin film such as polyamide. However, if you use such a packaging container, you will not be able to release it!
) When one-ray sterilization is performed, there is a problem in that a very small amount of decomposed products of the packaging container or medical device remain due to radiation irradiation, and this can be felt as an odor when the package is opened. ■Object of the Invention Accordingly, an object of the present invention is to provide a novel medical packaging container. Another object of the present invention is to provide a packaging container that does not give off any odor after opening when sterilized by radiation. Various aspects of these include a synthetic resin layer containing 0% by weight or more of an α-A olefin-unsaturated carbon type copolymer on at least a portion of the inner surface of a sealed bag made of a synthetic resin film. This is achieved by a medical packaging container made of laminated layers. The present invention also provides a packaging container in which the copolymer-containing synthetic resin layer is laminated on the entire inner surface of a bag-like object. Furthermore, the present invention provides that the bag-like article is made of a synthetic resin film formed by laminating the synthetic resin layers containing the copolymer, and the synthetic resin film containing the copolymer is layered in a furnace so that the synthetic resin layer containing the copolymer is located on the inner surface. The present invention also provides a packaging container in which the (χ-A lenoine-unsaturated carboxylic acid copolymer is) 0.2 to 20 mol% of unsaturated carboxylic acid, and MF
R (Melt Ilo+v Rate) is 0.2~
The packaging container is 30g/min. The present invention also provides a packaging container in which the unsaturated carboxylic acid is methacrylic acid, acrylic acid, or maleic acid. The present invention is a packaging container in which the content of α-olefin-unsaturated carboxylic acid copolymer in the laminated synthetic resin layers is 80% by weight or more. The present invention also provides a packaging container in which the synthetic resin film is polyester or polypropylene. The present invention is a packaging container which is an ionomer resin in which 90% or less of the unsaturated carboxylic acid of an α-olefin-unsaturated carboxylic acid copolymer is neutralized with a metal compound. The present invention is a packaging container in which the ionomer resin has a metal neutralization rate of 20 to 50%. Furthermore, the present invention provides that the copolymer-containing resin layer has a thickness of 5 to 50%.
90 ttrn packaging container. ■1 Detailed description of the invention Next, refer to the drawings 1. An embodiment of the present invention will now be described. That is, in a medical packaging container according to the present invention, for example, a radiation sterilization packaging container 11J, as shown in Figures 1 to 2, a part of the inner surface of a sealed bag made of a synthetic resin film 2 is , is formed by laminating a total of 3 synthetic resin layers containing an α-olefin-unsaturated carboxylic acid copolymer, usually 3 synthetic resin layers containing an α-olefin-unsaturated carboxylic acid copolymer
The peripheral edge portion 4 is heat-sealed via the. The synthetic resin layer containing the α-olefin-unsaturated carboxylic acid copolymer has the function of adsorbing decomposed products in the packaging container and suppressing the generation of decomposed products from the synthetic resin film 2 during radiation sterilization. FIG. 3 shows another embodiment of the present invention, in which a synthetic resin layer 3 containing an α-olefin-unsaturated carboxylic acid copolymer is provided on one side of the inner surface of a sealed bag made of a synthetic resin film 2.
It is formed by laminating layers 3 to z-periphery 4 through layer 3.
1 - It is sealed. Figure 4

[, 1. This shows still another embodiment of the present invention, in which a synthetic resin layer 3 containing an α-Δ olefin-unsaturated carboxylic acid co-assembly is formed on the entire inner surface of a sealed bag-like object made of a synthetic resin film 2. The peripheral edge 4 is heat-sealed via the layer 3. The resin layer 3
By laminating the film on the entire inner surface of the cough bag, generation of decomposed products from the film 2 can be suppressed over the entire surface, which is more preferable. The synthetic resins used in the present invention include polyesters such as polyethylene terephthalate-1 and polybutylene terephthalate, polypropylenes such as biaxially oriented polypropylene, and non-breathable resins such as transparent thermoplastic resins such as polyamides. Thickness: 5-150μ, preferably 10-60μ
It's a brutal film. The α-AI nofin-unsaturated carboxylic acid copolymer-containing resin is an α-olefin-unsaturated carboxylic acid copolymer alone or a mixture of the α-olefin-unsaturated carboxylic acid copolymer and other low melting point thermoplastic resin. The content of α-A olefin-unsaturated carbon type copolymer is 50% by weight or more, preferably 80% by weight or more. The α-olefin-unsaturated carboxylic acid copolymer is composed of an α-olefin (preferably ethylene) and an unsaturated carboxylic acid (
(For example, methacrylic acid, acrylic acid, oleic acid, etc., or methacrylic acid). In addition, an ionomer resin having a structure in which an unsaturated carboxylic acid is neutralized with a metal has an even greater odor removal effect. This has a structure in which good chain molecules are crosslinked with metal ions. Examples of metals used for crosslinking include copper, sodium, potassium, calcium, and magnesium. α-AI Nofin~
[Neutralization of unsaturated unsaturated carboxylic acid symbiotic polymer] The content of rubonic acid is 0.5 to 20 mol%, preferably 1 to 4 mol%.
1, and the neutralization rate by the metal is 90% or less,
Preferably it is 20-50%. Furthermore, MFR(A
TSM DI238) is 0.2 to 30 (1/min, preferably 0.7 to 15 rr,,' min.
When the amount is less than 20 mol %, the odor removal effect of the illuminated sliding door is excellent, while when it is less than 20 mol %, the resin flow characteristics and other properties are excellent. Regarding the neutralization rate by metal, when it is 20% or more, the odor removal effect after radiation irradiation is excellent, whereas when it exceeds 90%, the physical properties such as flow characteristics of the resin tend to deteriorate. In addition, the low melting point thermoplastic resins that are blended into this α-olefin-unsaturated carboxylic acid copolymer include transparent resins such as polyethylene and ethylene-vinyl acetate copolymer, whose number average molecular m is 5.゜、ooo〜i、ooo、
ooo, preferably Ha100,000-500,000
It is. Such an α-olefin-unsaturated carboxylic acid copolymer-containing resin layer can be applied, for example, to the surface of a synthetic resin layer in a molten state.
It is laminated by a method such as extruding a resin containing a Δrefin-unsaturated carbonaceous compound from a die and pressing it together, or extruding both resins simultaneously from separate dies and pressing immediately, etc., and the thickness after lamination is 30 ~ It is 150 μm, preferably 40 to 90 μm. The laminated sheet thus formed is folded with the α-olefin-unsaturated carboxylic acid copolymer-containing resin layer inside, or two sheets are stacked with the resin layers inside each other for medical use. fl is placed between the laminated films, the periphery of the overlapped portion of the laminated film is sealed by heat sealing, and then sterilized by irradiation with radiation. The radiation used includes electromagnetic radiation such as gamma rays and electron beams, preferably gamma rays. The irradiation intensity of A is 1 to 5 M rad, 9.7 or 2 to 3 M rad.
It is arrl. However, medical devices that can be subjected to radiation sterilization using the packaging container according to the present invention include, for example, disposable syringe nails and disposable syringes. Disposable blood collection kits, sutures, medical non-woven fabrics,
Absorbent cotton 1 Artificial surface tube, catheter, etc. Next, the present invention will be explained in more detail with reference to Examples. Example 1 MFR5,O made by neutralizing 30% of Eblen-methacrylic resistant coda composite with methacrylic acid content of 3.0 mol% with zinc
+ J/min of ionomer resin 90 heavily affected areas and poly, clove -
Len (number average molecular weight 100,000) 10 weight fl1%
The resin composition was laminated to a thickness of 20 μm on a 16 μm thick polyester terephthalate film to form a laminated film of 1 q. It was bent with the compound layer side inward, a disposable syringe was inserted between the -, and the periphery was heat-sealed. An odor sensory test was conducted in the following manner: After opening the package, the user immediately brought his/her nose close to the odor and smelled it.The results are shown in Table 1. "Steps of Strength" (Tensile Test Method/Comments 1980. P104G
). One sample envelope was opened every 5 minutes. Note that the order of the samples given to the 20 people was not fixed. The results are shown in Table 2 - 4゜Example 2 In the method of Example 1, an ethylene-methacrylic acid copolymer with a methacrylic acid content of 3.0 mol% was mixed with zinc to 25%
A resin composition consisting of 90 parts by weight of a neutralized ionomer resin with an MFR of 14, Og/min and 5 parts by weight of an ethylene-vinyl acetate copolymer with a number average molecular weight of 70,000>1. Except for this, a packaging container was manufactured using the same method and a similar test was conducted. ? It was done. Example 3 A packaging container was manufactured in the same manner as in Example 1, except that biaxially oriented polypropylene was used instead of polyethylene terephthalate as the outer layer, and a similar test was conducted. The results in the table were 1q. Example 4 'h? of Example 1? h, for the outer layer, biaxially oriented polypropylene was used instead of polyethylene derephthalate (1), and for the inner layer, polyethylene-acrylic acid conjugate (1) was used.
M F R9 (manufactured by Mitsubishi Yuka Co., Ltd.) resin was used.Other than (1) When a packaging container was manufactured in the same manner and the same test was conducted, the results in Table 2 were obtained. (qra l"1
．． i: . Further, similar results were obtained when ethylene-methacrylic mLJt 1 l wood and J-ethylene leic acid copolymer were used as the inner layer. Comparative Example 1 A packaging container was manufactured in the same manner as in Example 1, except that polyethylene ethylene (number average molecular weight FF 190,000) was used as the inner layer, and a similar test was conducted. The results in Table 2 were calculated by 1q. Comparative Example 2 A packaging container was prepared in the same manner as in Example 1 except that an ethylene-vinyl acetate copolymer (number average molecular weight 70,000) was used as the inner layer. WA3i!!shi, same t
When various tests were conducted, the results shown in Table 2 were obtained. Comparative Example 3 A packaging platform was manufactured in the same manner as in Comparative Example 1, except that biaxially oriented polypropylene was used instead of polyethylene terephthalate as the outer layer, and the same tests were conducted, as shown in Table 2. The result is 1! It's seven years old. (J Su bottom margin) Moga 1 L O odorless 1,・'2 R small limit (very slightly felt) 1
Clear (feeling or not unpleasant) 2 Antagonism
- 3 Strong (uncomfortable) 4 Very strong (very unpleasant) 5 Unbearable (makes you feel nauseous) Table 2 fFf+IIi OL'21 2345th bow Example 10 8 9 3 000 Example 20
9 9 2000 Example 30 9 7 3100 Example 40 5 105000 Comparative example 1 0 0 15 6 8 0 Comparative example 2 0
0 2 3 6 9 0 Comparative example 3 0 0 0
7 6 7 0■0 Specific Effects of the Invention As described above, the medical packaging container according to the present invention is made of a synthetic resin film. Since it is made of laminated synthetic resin layers containing 50% by weight or more of an unsaturated carboxylic acid copolymer, it not only suffers less deterioration due to RFL sword rays when sterilized by radiation irradiation, but also
Since the generated odor is also substantially absorbed by the resin layer containing the α-olefin-unsaturated carboxylic acid copolymer, there is no discomfort when opening the package. In addition, the packaging container can more completely suppress the generation of decomposition products from the synthetic resin film by laminating the copolymer-containing resin layer on the inner surface of the bag-like object, and has a larger area. The adsorption effect increases. Furthermore, α−
It is more preferable that the olefin is ethylene because it is difficult to be decomposed by gamma rays, and when the unsaturated carboxylic acid is 0.5 mol% or more, it has excellent adsorption properties, and when it is 20 mol% or less, it has excellent adsorption properties, and M F ' When R is in the range of 0.2 to 30 q/min, the workability is excellent. Furthermore, when the unsaturated carboxylic acid is methacrylic acid, acrylic acid, or maleic acid, the adsorption properties are particularly excellent. Also, α-olefin-
If the content ffl of the unsaturated carboxylic acid copolymer is 80 or more, the adsorptivity is even better. Furthermore, by using polynisol or polypropylene as the synthetic resin film, the heat resistance f1 can be increased during heat sealing.Also, when the unsaturated carboxylic acid is a resin with a structure in which it is neutralized by a metal, If the metal neutralization rate of Eye Δ Tsumar resin is higher than 20%, the adsorption effect against odors will be even greater.
On the other hand, if it is less than 50%, it is difficult to decompose. Furthermore, the thickness of the synthetic resin containing the round hand union is 5 to 90 μm.
If it is 11, it is preferable in terms of hardness as a packaging container and prevention of pinholes during manufacturing.

[Brief explanation of the drawing]

FIG. 1 is a perspective view showing an example of a packaging container according to the present invention, FIG. 2 is a cross-sectional view taken along the line -II of FIG. 1, and FIG. FIG. 4 is a sectional view similar to FIG. 2 showing another example. 1... Packaging container, 2... Synthetic resin layer, 3... α
- olefin-unsaturated carbon M polymer-containing resin layer,
4... Peripheral area.

Claims (1)

[Scope of Claims] (1) At least a portion of the inner surface of the airtight bag made of a synthetic resin film contains 50% or more of α-oleeno, 19% or more of unsaturated carboxylic acid co-IF. A medical packaging container comprising laminated synthetic resin layers. (2) A packaging container according to claim 1, wherein the copolymer-containing synthetic resin layer is laminated over the entire inner surface of a bag-like object. 3) The bag-like article is made by laminating a synthetic resin film containing the copolymer-containing synthetic resin layer, and forming an M layer such that the copolymer-containing synthetic resin layer is placed on the inner surface (II! The packaging container according to claim 2, wherein the packaging container is heat-sealed at the peripheral edge thereof. (4) The α-Δ olefin-unsaturated carboxylic acid copolymer is] A copolymer containing 0.5 to 20 mol% of the unsaturated carboxylic acid and an MFR of 0.2
~30(+/min) Claims 1 to 3
Packaging containers described in any one of the paragraphs. (5) The packaging container according to claim 4, wherein the unsaturated carboxylic acid is methacrylic acid, acrylic acid, or maleic acid. (6) Any one of claims 1 to 5, wherein the content of the α-A olefin-unsaturated carboxylic acid copolymer in the single synthetic resin layer is 80% or more. The packaging container described in . (7) The packaging container according to any one of claims 1 to 61r1, wherein the synthetic resin film is polyester or polypropylene. (8) Claims 1 to 7 are ionomer resins in which the unsaturated carboxylic acid of the α-A olefin-unsaturated carboxylic acid copolymer is neutralized by 90% or less with a metal compound.
Packaging containers described in any one of the paragraphs. (9) The metal neutralization rate of the ionomer resin is 20 to 50%
The packaging container according to claim 8, which has a temperature of 0.degree. (10) The thickness of the copolymer-containing synthetic resin layer is 5 to 90 μm
The packaging container according to any one of claims 1 to 9, which is m.