JP2003038638A - Tube for transfusion bag - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a tube for a transfusion bag which has the flexibility approximately equal to that of the conventional tube made of a soft polyvinyl chloride resin, is excellent in heat resistance as well and is small in the degree of elongation even under a high load. SOLUTION: This tube for the transfusion bag is formed of a resin composition consisting of 50 to 90 wt.% styrene elastomer (A) having Shore hardness of A35 to A70, tensile strength of 5 to 25 MPa and elongation of 800 to 1,000% and 10 to 50 wt.% at least one kind of a component (B) selected from the group consisting of an olefinic elastomer, polyolefin and polyolefin copolymer.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to a tube for an infusion bag used in a medical infusion bag.

[0002]

2. Description of the Related Art Conventionally, resin tubes have been frequently used as tubular members in infusion bags and various catheters. Such a medical tube is required to have performance such as safety, flexibility, and transparency, and has a function of transferring a drug solution, blood, drainage, air, etc., so that a flow path is always secured. Is important, and it is also required to have a property of being hard to bend, that is, to have kink resistance.

For this reason, soft polyvinyl chloride resin has been widely used as a material for medical tubes. However, the polyvinyl chloride resin has problems that special care is required during incineration treatment and that the plasticizer contained in the polyvinyl chloride resin is eluted into a chemical solution or the like.

On the other hand, there is no general-purpose polyolefin resin such as polyethylene or polypropylene which has a satisfactory level of flexibility required for medical tubes. Among the polyolefin resins, ethylene-vinyl acetate copolymer Coalescence is relatively flexible,
After all it is not enough as a material for medical tubes,
It also has poor heat resistance.

Further, as described in Japanese Patent Application Laid-Open No. 8-131537, a thermoplastic elastomer has recently attracted attention as a substitute material for a polyvinyl chloride resin, but such a general thermoplastic elastomer is However, since it is excellent in flexibility, it has a large elongation, and when it is used in a portion to which a load is applied, such as an infusion bag, it expands, and there is also a problem that it cannot fulfill its function as a tube.

[0006]

SUMMARY OF THE INVENTION The present invention has been made in view of the above problems, and has the same flexibility as that of a conventional tube made of a soft polyvinyl chloride resin.
It is an object of the present invention to provide a tube for an infusion bag which is excellent in heat resistance and has a small degree of elongation even under a high load.

[0007]

The present invention is based on JIS K-
6301 has a Shore hardness of A35 to A70 measured based on a hardness test, a tensile strength of 5 to 25 MPa and an elongation of 8 measured based on a tensile test.
Styrene-based elastomer (A) which is from 0 to 1000%
50 to 90% by weight and 10 to 50% by weight of at least one component (B) selected from the group consisting of olefin elastomers, polyolefins and polyolefin copolymers.
A tube for an infusion bag formed from a resin composition comprising Hereinafter, the present invention will be described in detail.

The resin composition constituting the tube for an infusion bag of the present invention contains 50 to 90% by weight of a styrene elastomer (A) having specific physical properties, a group consisting of an olefin elastomer, a polyolefin and a polyolefin copolymer. At least one component (B) selected from
It is contained in an amount of 0 to 50% by weight.

The styrene elastomer (A) having the above-mentioned specific physical properties is composed of polystyrene in the hard segment,
Polybutadiene, polyisoprene, soft segment
A block copolymer having a polyolefin or the like,
The three physical property values of hardness, tensile strength, and tensile elongation are limited to specific ranges. Such physical property values are JI
It is measured based on a hardness test and a tensile test in a vulcanized rubber physical test method defined in SK-6301 (revised 1995).

The styrene elastomer (A) has a Shore hardness of A35 to A7 measured based on a hardness test.
0, the tensile strength measured based on the tensile test is 5 to 25
MPa, elongation measured based on a tensile test is 800 to
1000% is used.

Among the styrene elastomers (A) satisfying the above-mentioned physical properties, the soft segment is one of ethylene-butylene random copolymer, ethylene-propylene copolymer or ethylene- (ethylene-propylene) random copolymer. More preferably, a styrene elastomer composed of one of the above or a combination of two or more thereof is used.

The styrene elastomer (A) is, for example, a product name "Clayton" or "Califlex" manufactured by Shell Chemical Co., a product name "Toughprene" manufactured by Asahi Kasei Co., Ltd., a product name "Lavalon" manufactured by Mitsubishi Chemical Co. Product name "Septon" / "High Blur", product name "Dynaron" manufactured by JSR, product name "Elastomer AR" manufactured by Aron Kasei, product name "Sumitomo TPE" manufactured by Sumitomo Chemical Co., Ltd. It can be obtained by selecting a specific grade.

In addition to the above styrene elastomer (A), the resin constituting the infusion bag tube of the present invention includes:
At least one selected from the group consisting of olefin elastomers, polyolefins and polyolefin copolymers
The seed component (B) is included.

The above-mentioned olefin elastomer has polyolefin such as polypropylene and polyethylene in the hard segment and ethylene propylene rubber (EPR) in the soft segment and is not particularly limited, but for example, manufactured by Sumitomo Chemical Co., Ltd. Product name "Excellen", product name "SPX" / "Zela" manufactured by Nippon Polychem
s ”or the like can be used.

The above-mentioned polyolefin is not particularly limited, and examples thereof include low density polyethylene, linear low density polyethylene, medium density polyethylene, high density polyethylene, crosslinked polyethylene, polypropylene and polybutene-1. In the present invention, polypropylene is particularly preferably used. In addition, as the polyolefin-based copolymer, a propylene-α-olefin copolymer, an ethylene-ethyl acrylate copolymer, an ethylene-methyl methacrylate copolymer, an ethylene-vinyl acetate copolymer and the like are used.

The resin constituting the tube of the present invention comprises 50 to 90% by weight of the component (A) (styrene-based elastomer) and 10 to 50% by weight of the component (B) (olefinic elastomer, polyolefin, polyolefin copolymer). % And. This is because if the proportion of the styrene-based elastomer is less than 50% by weight, the tube for an infusion bag will be too hard, and if it exceeds 90% by weight, the stiffness will be lost and it will not be usable.

If desired, various additives such as stabilizers and colorants may be added to the resin composition.

The infusion bag tube of the present invention has a tube length of 5 cm and is subjected to a tensile test using a tensile tester at a speed of 50 mm / min to obtain 50 N.
It is preferable that the elongation at the time of reaching the tension is 30% or less. This is because the present invention is a medical-use tube intended to be used in a portion to which a relatively large load is applied, that is, an infusion bag.

[0019]

EXAMPLES The following examples are given to explain the present invention in more detail, but the present invention is not limited to these examples. Examples 1 to 3 and Comparative Example 1 Using various resin compositions based on the compositions shown in Table 1, tubes having an inner diameter of 6.0 mm, an outer diameter of 7.5 mm and a length of 30 cm were molded by an extrusion molding device.

[Evaluation] Using the tube obtained above, the following evaluation was performed in an atmosphere of 25 ° C. and 50% RH, and the results are shown in Table 1. (Flexibility) A compression tester was used to measure the load when the tube was pressed half (3 mm) with a pressing rod having a tip shape of 15 mmφ at a speed of 10 mm / min. The average value of 5 measurements was used as a measure of flexibility. (Elongation) A tube cut into a length of 5 cm was subjected to a tensile test at a speed of 50 mm / min using a tensile tester to measure the elongation when a tension of 50 N was reached. The average value of 5 measurements was used as the evaluation value. (Heat resistance) Each tube was allowed to stand under autoclave sterilization conditions (121 ° C, 20 minutes), and the presence or absence of deformation of the tube was observed, and the heat resistance was evaluated according to the following criteria. ◯: No deformation X: Deformation (safety / eluate test) For each tube, an eluate test was conducted according to the 14th revised Japanese Pharmacopoeia General Test Method Plastic Drug Container Test Method. As a result, those which conformed to the “polyethylene or polypropylene aqueous injection container” standard were indicated by “◯”.

[0021]

[Table 1]

As is clear from the results shown in Table 1, the tube of the present invention has suitable flexibility as a tube for an infusion bag,
It can be seen that it has elongation, heat resistance and safety.

[0023]

EFFECTS OF THE INVENTION Since the present invention has the above constitution, it has sufficient flexibility, elongation and heat resistance required for a tube for an infusion bag.

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Claims (3)

[Claims] 1. A styrene elastomer (A) having a Shore hardness of A35 to A70, a tensile strength of 5 to 25 MPa and an elongation of 800 to 1000% (50 to 90% by weight).
And a resin composition comprising 10 to 50% by weight of at least one component (B) selected from the group consisting of olefin elastomers, polyolefins and polyolefin copolymers. 2. The styrene elastomer (A) is
A block copolymer composed of a hard segment made of polystyrene and a soft segment made of polyolefin, wherein the soft segment is an ethylene-butylene random copolymer, an ethylene-propylene copolymer and an ethylene- (ethylene-propylene ) The tube for an infusion bag according to claim 1, wherein the tube is at least one selected from the group consisting of random copolymers. 3. The tube for an infusion bag according to claim 1, which has an elongation of 30% or less.