《欧洲药典》包装标准体系概况与进展  

Overview and Progress of Packaging Standard System in European Pharmacopoeia

作　　者：徐俊 蔡荣 杨美成 陈蕾[2] XU Jun;CAI Rong;YANG Meicheng;CHEN Lei(Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203,China;Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]上海市食品药品包装材料测试所,上海201203 [2]国家药典委员会,北京100061

出　　处：《医药导报》2023年第7期1002-1008,共7页Herald of Medicine

摘　　要：目的概述《欧洲药典》包装标准体系及其发展,为我国药包材标准体系的建立与优化提供参考。方法解析《欧洲药典》包装标准体系结构与标准内容,关联比较各标准相互关系,评价相关策略的适用性。结果《欧洲药典》包装标准体系保持相对稳定并结合发展需求持续完善,材料标准具有鲜明特色,标准适用性和可操作性较平衡合理。结论《欧洲药典》对包装标准的预期管理,对材料以及允许添加剂的管理策略,对我国药包材标准体系建设具有重要参考价值。Objective To summarize the packaging standard system and its development in European Pharmacopoeia,and to provide reference for the establishment and optimization of the pharmaceutical packaging standard system in China.Methods The structure of the packaging standard system and the contents of the standards in European Pharmacopoeia were analyzed,the relationship between the standards was compared,and the applicability of the relevant strategy was evaluated.Results The packaging standard system in European Pharmacopoeia has remained relatively stable and been continuously improved in line with the needs of development.The standards of materials were of distinctive characteristics,and the suitability and operability of the standards are reasonably balanced.Conclusion The expectation management of packaging standards and the management policy of materials and accepted additives in European Pharmacopoeia are of great reference value to the construction of the pharmaceutical packaging standard system in our country.

关 键 词：欧洲药典 药包材 标准体系 

分 类 号：R95[医药卫生—药学]