4种药品包装材料的生物安全性评价  

Biological Safety Evaluation of Four Pharmaceutical Packaging Materials

作　　者：李晓春 王莉芳 徐长根 LI Xiao-Chun;WANG Li-Fang;XU Chang-Gen(Shaanxi Institute for Food and Drug Control, Xi’an 710065, China)

机构地区：[1]陕西省食品药品监督检验研究院,陕西西安710065

出　　处：《中国医药指南》2019年第12期48-49,共2页Guide of China Medicine

摘　　要：目的考察聚丙烯输液袋、塑料输液容器用聚丙烯组合盖(拉环式)、三层共挤输液用膜(Ⅰ)、袋及五层共挤输液用膜(Ⅰ)、袋4种药品包装材料的生物安全性。方法按照药包材生物学评价标准中的细菌内毒素试验、细胞毒性试验、皮肤致敏试验、皮内刺激试验、急性全身毒性试验、溶血试验、热原试验,分别对12个厂家的4个药包材品种进行安全性评价。结果 4种药品包装材料的安全性检查,结果均符合规定。结论 4种药品包装材料作为药包材用于临床是安全的。Objective To study the biological safety of PP infusion bottles, combinational closures of PP for plastic infusion containers(with ring-pull), 3-layer co-extrusion film(Ⅰ)and bag for infusion and 5-layer co-extrusion film(Ⅰ) and bag for infusion. Methods According to the standard of packaging materials biosafety evaluation, four pharmaceutical packaging materials from twelve manufacturers were tested by bacterial endotoxin test, cytotoxicity test, skin sensitization test, intracutaneous irritation test, acute systemic toxicity test, hemolysis test and pyrogen test. Results The results of the test were in accordance with the standards. Conclusions These four pharmaceutical packaging materials were safe to clinical use.

关 键 词：聚丙烯输液袋 塑料输液容器用聚丙烯组合盖(拉环式) 三层共挤输液用膜(Ⅰ)、袋 五层共挤输液用膜(Ⅰ)、袋 药包材 生物安全性评价 

分 类 号：R927[医药卫生—药学]