中国与欧美药品包装材料相容性研究规范  

Regulations and Technical Guidelines of Drug Packaging Material's Compatibility Study in China,EU and USA

作　　者：王学芬[1,2] 陈祖坚 闫超[1] 

机构地区：[1]上海交通大学药学院,上海200240 [2]纽迪希亚制药(无锡)有限公司,上海201204

出　　处：《广州化工》2014年第5期31-33,50,共4页GuangZhou Chemical Industry

摘　　要：药品包装是药品的重要组成部分,近年来由于药品包装选择不当,由药品与包装材料相容性引起的问题不断出现。本文综合收载了中国、欧盟以及美国的药品监管机构对药品与包装材料相容性研究的不同法规要求,希望能为药品生产企业及其研发机构进行相容性研究提供了基本的理论依据和试验思路。Drug packaging material was one of the important drug parts. In recent years, lot of issues which caused by the compatibility between drugs and packaging materials arose were because of wrong selection of packaging materials. The different regulations and technical guidelines in China, USA and EU were reviewed and analyzed, which related to the compatibility study between drug and packaging materials. It hoped to provide pharmaceutical company and research institution the basic theory and technical guidelines.

关 键 词：中国 欧美 药品 包装材料 相容性研究 法规要求 

分 类 号：R951[医药卫生—药学]