Thermoplastic elastomer for infusion bag and preparation method thereof

Abstract

The invention relates to thermoplastic elastomer for a transfusion bag and a preparation method of the thermoplastic elastomer for the transfusion bag. The thermoplastic elastomer for the transfusion bag comprises the following components in percentage by weight: 40-75% of medical-grade polypropylene (PP) serving as a component A, 15-30% of a nano crystal structure control type propylene elastomer (NOTIO) serving as a component B and 10-30% of ethylene-vinyl acetate (EVA) serving as a component C. A manufacturing technique of the thermoplastic elastomer comprises the following steps: weighing according to a formula, mixing raw materials, making materials in a twin-screw extrusion manner, carrying out grain-sized dicing by utilizing a water ring, drying, and sieving, thus obtaining the thermoplastic elastomer. The thermoplastic elastomer is completely non-toxic, auxiliaries such as a plasticizer and antioxidant are not needed to be added during processing, no low molecular weight organic matter is separated out, and the thermoplastic elastomer has the advantages of high transparency, high flexibility, resistance to high-temperature steam at the temperature of 121 DEG C and gamma ray sterilization, low quantity of particles, less diffusate, wide medicine compatibility and the like.

Description

technical field [0001] The invention relates to a thermoplastic elastomer and a preparation method thereof, in particular to a material used in the medical field to be directly blown and stretched to make an infusion bag or as an inner layer of a co-extruded film for an infusion bag. Background technique [0002] At present, in the field of infusion bag production, there are two kinds of materials: PVC (vinyl chloride) or its copolymer and non-PVC. [0003] The main problems of PVC are: (1) PVC contains polyvinyl chloride monomer, which is not conducive to human health. (2) In the production process of PVC, plasticizer (DEHP) is added to change its performance. During its use, DEHP may be dissolved. DEHP is a harmful substance and can release estrogen. Exposure to DEHP may cause reproductive system dysplasia , seriously endangering human health. (3) PVC and its copolymers have poor heat resistance, and the disinfection temperature can only be controlled below 110°C. The ba...

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Problems solved by technology

[0003] The main problems of PVC are: (1) PVC contains polyvinyl chloride monomer, which is not conducive to human health.

(2) In the production process of PVC, plasticizer (DEHP) is added to change its performance. During its use, DEHP may be dissolved. DEHP is a harmful substance and can release estrogen. Exposure to DEHP may lead to dysplasia of the reproductive system , seriously endangering human health

(3) PVC and its copolymers have poor heat resistance, and the disinfection temperature can only be controlled below 110°C. The bag is prone to deformation and bursting when the temperature rises, and cannot meet the sterility assurance requirements (F0<12) (the provisions of the Chinese Pharmacopoeia) Sterilization standard), also easily lead to drug contamination and deterioration and pyrogen reaction of patients

(4) After the empty PVC infusion bag is placed for half a year, alcohol leaching, reducing substances, zinc ions and pH value are likely to exceed the standard. In addition, during the storage process of the medicines packed in PVC bags, some medicines will undergo migration and adsorption reactions with PVC materials, thus Reduce the efficacy of the drug or even deteriorate and cannot be used

(5) After burning, PVC and its copolymers will form hydrochloric acid, which will cause respiratory damage to humans and animals and corrosion of buildings. In addition, dioxins will be easily produced during burning, which will have a profound impact on the environment.

[0004] Non-PVC special materials for infusion bags can be roughly divided into three categories: the first category is pure polypropylene, but pure polypropylene has relatively low flexibility, impact resistance, and low temperature resistance, which cannot meet the requirements of infusion bags.

The second type is modified polypropylene with styrene block copolymer (such as SEBS, SEPS) elastomer, because styrene block copolymer inevitably contains styrene monomer, and experimental studies have shown that styrene block copolymer During processing at high temperature, the substance may decompose to produce styrene monomer and other components. Styrene monomer has certain toxicity and has been listed as a carcinogen by the FDA. Therefore, this modified polypropylene is used in the infusion bag, and the residual Styrene may migrate from the packaging material into the liquid medicine and endanger human health, even life-threatening

The third category is modified polypropylene with ethylene copolymer elastomer (such as POE, POP). Due to the poor compatibility between ethylene copolymer elastomer and polypropylene, the transparency of modified polypropylene is reduced, especially when it is made After the infusion bag is sterilized, it is prone to whitening phenomenon, low light transmittance, and large haze, which makes it difficult to identify visible foreign objects in the liquid medicine, which increases the difficulty of light inspection and brings troubles to nurses before and after dispensing. Therefore, this modification Non-toxic polypropylene is used in infusion bags, there is a risk of drug safety

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