制药生产环境用消毒剂国内外标准比对  

Comparison of domestic and foreign standards for disinfectants used in pharmaceutical manufacturing environment

作　　者：冯丹阳 肖璜[2] 丁勃 马仕洪[2] FENG Danyang;XIAO Huang;DING Bo;MA Shihong(Shandong Institute for Food and Drug Control,Jinan 250101,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]山东省食品药品检验研究院,济南250101 [2]中国食品药品检定研究院,北京100050

出　　处：《中国药品标准》2020年第5期403-406,共4页Drug Standards of China

摘　　要：目的:对国内外制药环境用消毒剂标准进行比对,探讨中国药典消毒剂相关标准制定的方向。方法:对美、日两国药典、《消毒技术规范》2002版和欧洲标准从消毒剂分类、效能验证方法等方面分别进行对比和讨论。结果与结论:国外药典是建立中国药典消毒剂标准的主要参考,行业标准可在方法上作出补充。Objective:To compare domestic and foreign standards for disinfectants used in pharmaceutical manufacturing environment,and discuss the direction of the disinfectant standards in the Chinese Pharmacopoeia.Method:In the United States Pharmacopoeia,the Japanese Pharmacopoeia,the Technical Specification for Disinfection(2002)and the European Standard,the classification and efficacy verification methods of disinfectants were compared and discussed.Results and conclusion:The foreign pharmacopoeias were the main reference for the establishment of the disinfectant standards in the Chinese Pharmacopoeia,and other standards can be supplementary for the efficacy verification methods.

关 键 词：消毒剂 日本药典 美国药典 欧洲标准 效能验证 

分 类 号：R921.2[医药卫生—药学]