JPS6023621B2 - Vinyl chloride resin composition for medical devices - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a vinyl chloride resin composition for medical odors that does not contain any phthalate plasticizer and has excellent flexibility.

Therefore, vinyl chloride resin uses phthalate ester as a plasticizer to give flexibility and is used for medical disposable parts, such as blood transfusion sets, infusion sets, blood bags, artificial heart-lung disposable pull sets, artificial kidney disposable sets, etc. It is widely used in tubes, sheets, and connectors, and its safety is well known.

However, when a vinyl chloride resin composition containing a phthalate plasticizer is used as a material for storing high-calorie liquids, there is a problem because the phthalate plasticizer is largely eluted into the high-calorie liquid. The high-calorie liquid mentioned above is one that contains sugar, amino acids, fat emulsion, electrolyte, etc. The present invention uses 10 parts by weight of vinyl chloride resin, 5 to 75 parts by weight of polyurethane resin, 5 to 75 parts by weight of polyester plasticizer, and 5 to 3 parts by weight of epoxy plasticizer.
parts by weight, preferably the total of the three plasticizer components is 40 to 12
To provide a vinyl chloride resin composition which has flexibility and is excellent as a medical device for storing high-calorie substances, by blending it with 0 parts by weight and a stabilizer, a lubricant, etc.

The degree of polymerization of the vinyl chloride resin used in the present invention is 600-3
80" is better; if it is less than 600, the tear strength and tensile strength are low, and the plastic lacks flexibility and is unsuitable for use as a plastic for medical devices.

Moreover, those having P: 3,800 or more are difficult to polymerize, and there are no products available at a reasonable price. The polyurethane resin used in the present invention is preferably a polyurethane resin composed of a diisocyanate, a dibasic acid, and a polyol, and examples of the diisocyanate include diphenylmethane diisocyanate,
Hexamethylene diisocyanate, 4,4'-methylenebis(cyclohexyl diisocyanate), toluene diisocyanate, etc. are mainly used.

Preferred dibasic acids include adipic acid and maleic acid, and polyols include 1,4-butanediol, 1,3-butylene glycol, ethylene glycol, and propylene glycol. The polyester plasticizer used in the present invention is preferably a polyester plasticizer obtained by reacting a dicarboxylic acid with a diol, and the dicarboxylic acid includes adipic acid, sebacic acid, etc., and the diol includes propylene glycol, 1,
3-butanediol, ethylene glycol, 1,6-hexanediol, etc. are used.

The epoxy plasticizer used in the present invention is epoxidized soybean oil (iodine value 5 or less, oxirane oxygen 6% or more).
Alternatively, epoxidized linseed oil (iodine value 5 or less, oxirane oxygen content 9% or more) is suitable.

The present invention skillfully utilized the rubber elasticity of polyurethane resin, the high plasticization efficiency of polyester, and the thermal stability of epoxy among these plasticizers, studied their blending ratio, and found the above-mentioned blending ratio. It is.

Stabilizers, lubricants, etc. are added to the composition of the present invention in the same manner as in ordinary compositions. As stabilizers, compounds of higher fatty acids such as calcium or zinc are preferred, and other compounds such as lithium, sodium,
Potassium-, magnesium-, and aluminum-based stabilizers have poor initial coloration and cannot be used when made into sheets and tubes, and tin-based stabilizers cannot be used because of the problem of tin melting.

Also, suitable lubricants include fatty acid alcohol esters and liquid paraffin low-molecular polyesters. Molded products such as sheets and chews obtained from the composition of the present invention have good productivity, and have excellent tear strength, tensile strength, adhesiveness, flexibility, and hygienic properties. There is no elution.

Therefore, a vinyl chloride resin composition optimal for medical devices can be provided. This will be explained below using examples.

Example 1 To a product having the composition shown in Table 1, 1 part by weight of a composite of calcium stearate and zinc stearate as a stabilizer and 0.5 part by weight of stearic acid alcohol ester as a thickener were added, and the mixture was subjected to the usual soft calendering method. A sheet was prepared using the following method, and the properties of this sheet were measured, and the results shown in Table 1 were obtained.

Products using PVC with a low degree of polymerization have low tear strength, and other plasticizers were tested. No. 5.6 is particularly unsuitable for this purpose because the plasticizer is leached into the high-strength rolly liquid.

Experiment No. PVC having a polymerization degree of 600 or higher as described in 2.3.4 and using the mixed plasticizer of the present invention is a composition that is satisfactory as a medical device. Practical Example 2 Stabilizers and lubricants were added in the same manner as in Example 1 to compositions with various amounts of plasticizer as shown in Table 2, sheets were made, and their properties were measured. The results were obtained.

In addition, a sheet without epoxidized soybean oil was also investigated, but the thermal stability was poor and a good sheet could not be obtained. Also, experiment no. If the amount of epoxidized soybean oil is increased as in No. 13, the plasticizer will leak into the high-calorie liquid, which is not preferable.
Without the polyurethane resin, hygiene is poor, and without the polyester plasticizer, the productivity and processability of the tube or sheet are poor, making it unsuitable for this purpose. Experimental site. 9-12
The composition of the present invention satisfies all of the objects and is very useful as a medical odor. Table 1 Table 2 Note 1 Polyurethane resin T-5265 Manufactured by Dainippon Ink Co., Ltd.

Claims (1)

[Claims] 1. Vinyl chloride for medical devices, characterized in that 5 to 75 parts by weight of polyurethane resin, 5 to 75 parts by weight of polyester plasticizer, and 5 to 30 parts by weight of epoxy plasticizer are blended to 100 parts by weight of vinyl chloride resin. Resin composition.