JP3243084B2 - Base material for medical containers - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a flexible container (bag) for storing and preserving liquids used in medical treatment such as blood and medical liquids,
The present invention relates to a medical container base material excellent in transparency and flexibility suitable for a tube (connecting tube) to be conveyed.

[0002]

2. Description of the Related Art As materials for containers and tubes used in medical fields such as blood collection, blood transfusion, and transfusion, various performances are required in addition to safety and hygiene, but in terms of ease of handling. Transparency and flexibility are of particular importance.

[0003] Typical examples of the polymer material for this use include soft polyvinyl chloride, polyethylene-based polymers such as ethylene-vinyl acetate copolymer and low-density polyethylene, and polypropylene. Although good flexibility and transparency are exhibited by adjusting the amount, attention must be paid to the dissolution of the plasticizer, and the problem of disposal after use tends to occur.

In the case of polyolefins such as polyethylene and polypropylene, transparency and flexibility are naturally limited because they are essentially crystalline polymers, and are inferior to soft polyvinyl chloride. The introduction of a polymerization component and the addition of a transparency-imparting agent such as an olefin-based elastomer or a styrene-based elastomer naturally have limitations, and the actual use is limited. Among polyolefins, ethylene copolymers such as ethylene vinyl acetate copolymer and ethylene-methyl methacrylate copolymer are excellent in transparency, but may not satisfy requirements in terms of flexibility.

[0005]

SUMMARY OF THE INVENTION An object of the present invention is to provide a medical container base material having both transparency and flexibility, which solves the above-mentioned problems in the prior art.

[0006]

[Means for Solving the Problems ] Means for Solving the Problems
Is ethylene vinyl acetate copolymer, ethylene acrylic
Acid ester copolymer or ethylene-methacrylic acid
Ester copolymer (A) and isobutylene as main components
Polymer Composition with Amorphous Polybutene-Based Polymer (B)
It is a base material for a medical container that contains a substance as a forming layer. Also on
The solution to this problem is ethylene vinyl acetate copolymer.
-, Ethylene acrylate copolymer or d
A tylene-methacrylate copolymer (A);
Amorphous polybutene polymer based on sobutylene
(B: Hereinafter, "polybutene-based amorphous polymer"
U. ) And the crystalline polypropylene-based polymer (C)
A medical container base material comprising a polymer composition as a forming layer.
You.

That is, a polymer composition of an ethylene-vinyl acetate copolymer, an ethylene-acrylate copolymer or an ethylene-methacrylate copolymer (A) and a polybutene-based amorphous polymer (B), or (A), (B) and The gist is a base material for a medical container containing a polymer composition of a crystalline polypropylene-based polymer (C) as a forming layer, and the excellent compatibility, flexibility, and transparency-imparting effect of the polybutene-based amorphous polymer (B) are the above combinations. In which a good expression is obtained.

First, regarding (A), an ethylene-vinyl acetate copolymer (hereinafter referred to as EVA) is a polymer produced by a generally known method, and the effect of the present invention is to improve flexibility and transparency. (Compatibility with (B))
In consideration of the above, it is preferable that the vinyl acetate content is about 5 to 40% by weight, more preferably about 8 to 35% by weight. In addition, the temperature of 190
The melt flow rate (MFR) at 0.2 ° C. and a load of 2,160 g is preferably from 0.2 to 20, more preferably from 0.5 to 10. Examples of the ethylene-acrylate copolymer and ethylene-methacrylate copolymer include ethylene-methyl acrylate copolymer (EMA)
And ethylene-ethyl acrylate copolymer (EEA),
Ethylene-methyl methacrylate copolymer (EMMA)
And ethylene-ethyl methacrylate copolymer (EE
MA) is a representative example, and EEA and EMMA are particularly preferred in terms of versatility. These copolymers are EVA
For the same reason as above, the content of the acrylate or methacrylate is 5 to 35% by weight, more preferably 8 to 35% by weight.
33% by weight, MFR of 0.1 to 20, more preferably 0.2 to 15 is recommended.

Next, the polybutene-based amorphous polymer (B) in the present invention means an amorphous polybutene-based polymer containing isobutylene as a main component and can be obtained by a generally known method. Of these, particularly preferred are polymers containing isobutylene as a main component and butene-1 as a copolymerization component in an amount of about 5 to 30%.

From the viewpoint of moldability and mechanical properties of the polymer composition, (B) has a kinematic viscosity at 100 ° C. of 2,000.
0 to 20,000 cst, more preferably 2,500 to
About 10,000 cst, pour point is 10-50
C, more preferably about 15 to 45C.

Next, the crystalline polypropylene-based polymer (C) in the present invention is an isotactic or syndiotactic polypropylene or a crystalline copolymer containing these as a main component, which is usually obtained using a stereoregular polymerization catalyst. . These are appropriately selected, but copolymers, particularly random copolymers, are advantageous in terms of flexibility and transparency. Comonomer is ethylene, butene
Α-olefins having 2 to 12 carbon atoms such as 1, pentene-1, hexene-1, octene-1, decene-1, dodecene-1, and 4-methylpentene-1 are preferred, and the comonomer amount is 3 to 40 mol. %, More preferably about 5 to 30 mol%.

The polypropylene-based crystalline polymer (C) has a flexural modulus (JIS K7203) of 8,000.
Vicat softening point at 0 kg / cm ² or less (JISK720
6) is 100 ° C. or higher, which is suitable from the viewpoint of balance between flexibility, transparency and heat resistance. Also moldability,
Considering the mechanical properties of the molded product, the temperature is 230 ° C,
The MFR (melt flow rate) under a load of 2,160 g is preferably 0.3 to 40, more preferably 5 to 30.

As described at the outset, the substrate of the present invention comprises:
The polymer composition composed of (A) and (B) is contained as a formation layer, or the polymer composition composed of (A), (B) and (C) is contained as a formation layer. “Included as a forming layer” means that the base material is composed of only the polymer composition (a) or (b) or that the polymer composition is composed of at least one layer and the other polymer is composed of at least one layer. It means that there may be a multi-layered body.

In the case of (b), the mechanical properties (flexibility, strength, etc.) of the container, moldability, heat sealability, and blocking resistance ((B) are sticky sheets and tubes made of a polymer composition) May be blocking), and the like, and the above-mentioned "other polymer" which forms a multilayer body is polyethylene, ethylene-vinyl acetate copolymer, ethylene-acrylate copolymer, ethylene-methacrylic acid Ester copolymer, crystalline polypropylene polymer, crystalline polybutene-1 polymer, poly-4-methylpentene-1, polyester, polyamide, polyetherester (polyethylene oxide, polypropylene oxide, ethylene oxide-propylene oxide copolymer, polytetramethylene oxide Such as Block copolymers), polyether amides of ether and polyester (block copolymer of the above-mentioned polyether and polyamide), polyurethane (especially polyether type is better)
Is mentioned.

Note here the thickness of the "other polymer". In other words, it is important to reduce the thickness of the “other polymer” layer for the purpose of expressing flexibility and transparency, which is the object of the present invention, and it is 0.08 mm or less, more preferably 0.05 mm or less per layer. There should be.

The composition of the polymer composition varies depending on whether the composition is the above, whether the base material is (a) a single layer or (b) a multi-layer, the application, etc., but generally (A) and (B) Weight ratio of 95 to 35: 5 to 65, more preferably 90 to 4
0:10 to 60, and (C) is preferably 60% by weight or less, more preferably 50% by weight or less in the polymer composition. The addition of (C) leads to an improvement in the mechanical properties of the composition, but care must be taken to increase the rigidity. In the case of a multilayer structure, it is needless to say that the proportion of (B) in the polymer composition should be relatively large.

The total thickness of the base material is 0.05 to 1.0 mm in the case of a sheet, more preferably 0.08 to 0.5 mm.
About 8 mm is appropriate, and 0.5 to 3.0 in the case of a tube.
mm, more preferably about 0.8 to 2.0 mm (the inner diameter of the tube is 1 to 20 mm, more preferably 2 to 15 mm.
mm is common).

In the present invention, the medical container means a container or a tube for storing or transporting a liquid to be treated in medical treatment such as blood or a medical solution, and such a product is usually obtained by a known method. (A), (B) and / or
Or extruding the polymer composition comprising (C) alone or simultaneously with another polymer through a T-die or a circular die (the melting temperature varies depending on the combination of the polymers, but generally ranges from about 160 to 250 ° C). The obtained flat sheet, tubular sheet, parison, etc. are processed into a predetermined shape and form by utilizing thermoforming, blowing, stretching, cutting, fusing (sealing), etc. as appropriate. do it.

The sheet may be either a non-stretched product or a stretched product.

In order to produce a multilayer sheet, a laminating method may be applied.

Needless to say, the inner and outer surfaces of the container may be roughened (embossed) or an antiblocking agent, a slip agent, etc. may be added to prevent blocking between sheets.

Further, a styrene-based elastomer, an olefin-based elastomer, and the like may be added as long as the gist of the present invention is not impaired. The extrusion molding method is most suitable for the production of the tube.

The substrate of the present invention is used as a container for preserving blood components (particularly platelets and plasma), as well as physiological saline, electrolyte solution,
It is particularly useful as a drug solution container for dextran preparations, mannitol preparations, saccharide preparations, amino acid preparations and the like.

[0024]

EXAMPLES The present invention will be described in more detail with reference to the following Examples, but it should not be construed that the invention is limited thereto.

The sheets (films) used here are all unstretched.

(Examples 1 to 6, Comparative Examples 1 and 2) (1) Sheet Preparation of polymer composition: EVA (A ₁ ), EMMA
(A ₂ ), polybutene-based amorphous polymer (B),
It is appropriately selected from the crystalline polypropylene-based copolymer (C) and supplied to a twin-screw melt-mixing extruder to obtain 160-210
The strands extruded by kneading in a temperature range of
Cutting, dried to obtain a pellet-like polymer composition _{(D 1) ~ (D 6} ). Table 1 shows an overview of the raw materials (A), (B) and (C) and the polymer composition (D).

Preparation of sheet: (A ₁ ), (C ₁ ),
Using (C ₂ ) and pellets of the polymer compositions (D ₁ ) to (D ₆ ), 17
The sheet was extruded at 0 to 210 ° C., cooled with a casting roller maintained at 20 ° C., trimmed, and wound up at a speed of 6 m / min with a sheet having a thickness of 0.32 mm and a width of 200 mm.

Measurement and evaluation of physical properties of the sheet: The transmittance of the sheet obtained at 450 nm in water at a wavelength of 450 nm was measured with a Shimadzu double beam type auto-recording spectrophotometer UV-300 and used as a measure of transparency. The sheet obtained was cut into a dumbbell shape, and the tensile modulus was measured according to JIS K7113 to obtain a measure of flexibility. Table 2 shows the results.

The test for heavy metal and dissolution of the sheet was performed according to the general test method of the Japanese Pharmacopoeia, "Test method for plastic containers for infusion".

[0030]

[Table 1]

(2) Results of Evaluation of Physical Properties (See Table 2) All sheets were produced smoothly, and in any composition, a sheet having high uniformity was obtained without observing foreign matters and foaming.

Table 2 shows the composition of the sheet and the light transmittance.
As shown in the relationship with the tensile modulus, it was confirmed that EVA and EMMA were softened while maintaining transparency.

In each case, it was confirmed that the heavy metals and the eluates conformed to the Japanese Pharmacopoeia.

[0034]

[Table 2]

[0035]

As described above, the base material for a medical container of the present invention comprises a polyethylene polymer (A) such as EVA or EMMA and a polybutene amorphous polymer (B), and further comprises (A) and (B). And a good use of the good compatibility between the crystalline polypropylene 1-based polymer (C) and the polymer container. The medical container has good transparency and flexibility, and good hygiene and moldability. Some industrial substrates have high industrial value.

──────────────────────────────────────────────────続 き Continuation of the front page (56) References JP-A-54-88950 (JP, A) JP-A-61-34030 (JP, A) JP-A-58-169466 (JP, A) 104268 (JP, A) JP-A-55-40563 (JP, A) JP-A-4-303452 (JP, A) JP-A-3-218770 (JP, A) JP-A-3-51049 (JP, A) JP-A-59-97670 (JP, A) JP-A-4-292170 (JP, A) JP-A-58-165866 (JP, A) JP-A-5-31156 (JP, A) (58) (Int.Cl. ⁷ , DB name) A61J 1/10

Claims (4)

(57) [Claims] 1. An ethylene vinyl acetate copolymer, an ethylene acrylate ester copolymer or an ethylene-methacrylate ester copolymer (A) , and isobutylene
A base material for a medical container comprising, as a forming layer, a polymer composition with an amorphous polybutene-based polymer (B) whose main component is 2. Ethylene vinyl acetate copolymer, ethylene
Acrylic acid ester copolymer or ethylene-
Acrylate copolymer (A) and isobutylene
An amorphous polybutene-based polymer (B) containing, as a main component,
Polymer composition with crystalline polypropylene polymer (C)
Base material for medical containers containing a product as a forming layer. 3. The amorphous polybutene-based polymer according to claim 1,
Main component is sobutylene, butene-1 is 5-30% by weight
3. The composition according to claim 1, which is contained as a combined component.
Base material for medical containers. 4. A medical container in the medical container base material.
Is a blood component storage container or a drug solution container.
4. The medical container base material according to any one of 1 to 3.