A kind of film for disposable intravenous nutrition infusion bag and preparation method thereof

Abstract

The invention relates to a disposable venous nutrition transfusion bag film. The film comprises a heat sealing layer A, a structure layer B, a bonding layer C and an external layer D which are sequentially arranged from inside to outside, the material of the heat sealing layer A is ethylene-vinyl acetate (EVA), the material of the structure layer B is mixed resin composed of polyethylene (PE) and ethylene-octylene copolymer (POE), the material of the bonding layer C is maleic anhydride (MAH) modified ethylene-octylene copolymer (POE), and the material of the external layer D is mixed resin composed of polyester elastomer (TPEE), polyamide (PA) and a compatilizer. The disposable venous nutrition transfusion bag film can be disinfected through gamma-ray irradiation disinfection or 115-125DEG C high temperature steam disinfection, and has the advantages of no need of a plasticizer, few migration precipitates, excellent medicine compatibility, low making cost, high barrier performances, good protection on treatment and nutrition transfusion, reduction of the deterioration probability of medicines, and guaranteeing of patients' medicine taking safety.

Description

technical field [0001] The invention relates to a medical device, in particular to a film for a disposable intravenous nutrition transfusion bag and a preparation method thereof. Background technique [0002] At present, in the field of disposable intravenous nutrition infusion bag production, the bag body is divided into two kinds of materials: polyvinyl chloride (PVC) or its copolymer and ethylene-vinyl acetate (EVA). [0003] The main problems of polyvinyl chloride (PVC) are: (1) polyvinyl chloride (PVC) contains polyvinyl chloride monomer, which is not conducive to the health of the human body; Its performance adds diethylhexyl phthalate (DEHP) plasticizer, which may dissolve during its use, diethylhexyl phthalate (DEHP) plasticizer Hexyl ester (DEHP) is a harmful substance and can release estrogen. Exposure to diethylhexyl phthalate (DEHP) may lead to dysplasia of the reproductive system and seriously endanger human health; (3) Polyvinyl chloride (PVC) In the producti...

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Problems solved by technology

[0003] The main problems of polyvinyl chloride (PVC) are: (1) polyvinyl chloride (PVC) contains polyvinyl chloride monomer, which is not conducive to the health of the human body; Its performance adds diethylhexyl phthalate (DEHP) plasticizer, which may dissolve during its use, diethylhexyl phthalate (DEHP) plasticizer Hexyl ester (DEHP) is a harmful substance and can release estrogen. Exposure to diethylhexyl phthalate (DEHP) may lead to dysplasia of the reproductive system and seriously endanger human health; (3) Polyvinyl chloride (PVC) In the production process, in order to prevent the resin from degrading, stabilizers containing elements such as calcium, zinc, and barium are usually added. These metal ions may migrate during the infusion process and enter the human body with the liquid medicine or blood products, which will bring harm to human health. (4) Polyvinyl chloride (PVC) has strong adsorption to some fat-soluble and alcohol-soluble drugs, especially antitumor drugs, which leads to inaccurate prescription dosage and reduced curative effect; (5) PVC (PVC) and its copolymers will form hydrochloric acid after burning, 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] The main problems of ethylene-vinyl acetate (EVA) are: (1) The heat resistance of the material is not good, and the infusion bag will shrink and wrinkle when it is sterilized by high-temperature steam, which will also easily lead to the deterioration of the drug and the pyrogen reaction of the patient. ; (2) The mechanical properties of the material are poor. In order to increase the breaking force, it can only be compensated by increasing the film thickness. Usually the film thickness is 300-400um, so the manufacturing cost is greatly increased

Although the strength of the made infusion bag can meet the requirements of the national standard, the strength of the infusion bag is still not high, and it is prone to damage and leakage in practical applications; (3) the barrier performance is low, and the oxygen transmission rate is very large. Poor protection for treatment and nutritional infusions, resulting in reduced drug efficacy or even deterioration and unusable

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