聚丙烯安瓿的生物学试验

Biological Tests of Polypropylene Ampoule

目的观察聚丙烯安瓿对实验动物致敏作用的皮肤、皮内刺激作用、对细胞的毒性作用,对家兔血红细胞溶血作用以及细菌内毒素检查,为其作为药品包装材料用途的生物安全性评价提供科学依据。方法根据该产品的使用用途,按照药包材生物学评价标准选择细菌内毒素检查、细胞毒性试验、迟发型超敏反应试验、皮内反应试验、急性全身毒性试验和溶血试验进行生物安全性评价。结果细菌内毒素检查结果符合规定,细胞相对增殖度0级,未出现皮肤致敏反应及皮肤刺激反应,无急性全身毒性,溶血率小于5%。结论聚丙烯安瓿作为药包材用于临床使用是安全的。

Objective Observing sensitization and intracutaneous stimulation effect of polypropylene ampoule on animal skin,toxic effects on cell,on rabbit red blood cell hemolysis and bacterial endotoxin inspection,as biological safety evaluation of the use of pharmaceutical packaging materials and instruments provide scientific basis for them. Methods According to the use of the product,in conformity to the standards of biological evaluation of medical devices selection in bacterial endotoxin test,cytotoxicity test,delayed type hypersensitivity reaction test,intradermal reaction test,acute systemic toxicity test,hemolysis test of biological safety evaluation.Results The results of bacterial endotoxin test were in line with the requirements,the relative degree of cell proliferation was 0,and there was no skin irritation and skin irritation, and no acute systemic toxicity, and the hemolysis rate was less than 5%.Conclusion Polypropylene ampoule as medical device for clinical use is safe.