15版药包材标准下多层共挤输液用袋的生物安全性评价  

Biosafety Evaluation of Multi-layer Co-Extrusion Infusion Bag under 15th Edition Standard

作　　者：刘茜 严小莉 王莎莎 胡煜雯 高静贤 

机构地区：[1]江苏省医疗器械检验所(江苏省食品药品监督管理局医药材料容器产品质量监督检验站),南京210022

出　　处：《中国医疗器械信息》2017年第7期53-55,61,共4页China Medical Device Information

摘　　要：目的:研究15版药包材标准下三层(五层)共挤输液用袋袋体、塑料输液容器用聚丙烯接口和塑料输液容器用聚丙烯组合盖的生物安全性。方法:依据新版标准中的细胞毒性试验、细菌内毒素试验、致敏试验、皮内刺激试验、急性全身毒性试验及溶血试验,分别对样品进行生物学评价。结果:样品按新标准中规定的生物试验检查,结果均符合标准规定。结论:在新的药包材标准下,五层、三层共挤输液用袋袋体、塑料输液容器用聚丙烯接口和塑料输液容器用聚丙烯组合盖作为药品包装材料用于临床是安全的。Objective： To study the biological safetyof multilayer copolymer/zed compound membrane infusion packages（contain： packages＇body. Polypropylene Interface and Polypropylene combined cover）by the methods on 15 edition packaging materials standard. Methods： According to the new standard in the cytotoxicity test, the samples were tested by bacterial endotoxin test, cytotoxicity test, delayed-type hypersensitivity reaction test, intradermal reaction test, acute systemic toxicity test, hemolysis test. Results： the results of the test were in accordance with the standards specified in the new standard.Concluxion： in the new drug packaging standard, multilayer copolymerized compound membrane infusion packages is sale toclinical use.

关 键 词：药包材 多层共挤膜输液袋 生物安全性 

分 类 号：R927[医药卫生—药学]