直立式聚丙烯输液袋的生物安全性评价  

Biological Safety Evaluation of Upright Polypropylene Infusion Bag

作　　者：李晓春 王莉芳 徐长根 马丽 

机构地区：[1]陕西省食品药品监督检验研究院,陕西西安710065 [2]咸阳市中心医院药学部,陕西咸阳712000

出　　处：《世界最新医学信息文摘》2018年第45期195-196,共2页World Latest Medicine Information Electronic Version

摘　　要：目的考察直立式聚丙烯输液袋的生物安全性。方法按照药包材生物学评价标准中的细胞毒性试验、急性全身毒性试验、溶血试验、细菌内毒素试验、皮肤致敏试验、皮内刺激试验、热原试验,分别对三批样品进行安全性评价。结果 3批直立式聚丙烯输液袋的安全性检查,结果均符合标准规定。结论 3批直立式聚丙烯输液袋作为药包材用于临床是安全的。Objective To study the biological safety of upright polypropylene infusion bag. Methods According to the standard of packaging materials biosafety evaluation,three samples were tested by cytotoxicity test,acute systemic toxicity test,hemolysis test,bacterial endotoxin test,skin sensitization test,intracutaneous irritation test and pyrogen test. Results The results of the test were in accordance with the standards. Conclusions These three batches of upright polypropylene infusion bag were safe to clinical use.

关 键 词：直立式聚丙烯输液袋 药包材 生物安全性评价 

分 类 号：TQ460.69[化学工程—制药化工]