《美国药典》药包材标准体系概况与最新进展  

Overview and Latest Progress of Pharmaceutical Packaging Standard System in the United States Pharmacopoeia

作　　者：张芳芳 杨美成 蔡荣 凌霄 陈蕾[3] ZHANG Fangfang;YANG Meicheng;CAI Rong;LING Xiao;CHEN Lei(Shanghai Food and Drug Packaging Material Control Center,Shanghai 201203,China;Headquarters of the United States Pharmacopoeia Commission in China,Shanghai 200125,China;Chinese 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]美国药典委员会中华区总部,上海200125 [3]国家药典委员会,北京100061

出　　处：《医药导报》2023年第7期1009-1014,共6页Herald of Medicine

基　　金：国家药典委员会支持项目(药典综函[2022]303号);上海市市场监督管理局科技项目计划(2023-72)。

摘　　要：目的分析《美国药典》药包材标准体系概况及其最新进展,为我国药包材标准体系的建立与优化提供参考。方法对《美国药典》药包材标准体系框架结构与标准内容进行解析,对药包材产品标准和方法标准、美国药包材管理法规的相互关系进行比较分析。结果《美国药典》药包材标准体系相对完善,药包材评价标准具有鲜明特色,药包材标准贯穿药包材使用全生命周期,同时药典论坛定期更新。结论《美国药典》相对完善的药包材材质标准,产品标准与评价标准相互支撑并贯穿药包材使用全生命周期,都对我国药包材标准体系建设具有重要参考价值。Objective To study on the pharmaceutical packaging standard system and the latest progress in the United States Pharmacopoeia(USP),and to provide reference for the establishment and optimization of the pharmaceutical packaging standard system in China.Methods The structure of the pharmaceutical packaging standard system in USP and their contents were analyzed,the relationship among the packaging products standards,method standards,guidance for pharmaceutical packaging in USP were compared and analyzed.Results The pharmaceutical packaging standard system in USP is relatively complete,and the evaluation standards for pharmaceutical packaging materials have distinctive characteristics.The applicability of the standards is more comprehensively throughout the entire life cycle of pharmaceutical packaging material and pharmacopoeia forum updates periodically.Conclusion The relatively complete standards for pharmaceutical packaging materials in USP,mutually-supporting product standards plus evaluation standards throughout the entire life cycle of pharmaceutical packaging material are of great reference value to the construction of Chinese pharmaceutical packaging standard system.

关 键 词：中华人民共和国药典 美国药典 药包材 标准体系 

分 类 号：R95[医药卫生—药学]