《欧洲药典》(9.2)2.6.27.细胞制品的微生物检查  

EP 9.2 2.6.27. Microbiological examination of cell-based preparations

作　　者：刘洪祥 杨倩 解慧 曹晓云 白海娇 LIU Hongxiang;YANG Qian;XIE Hui;CAO Xiaoyun;BAI Haijiao(Tianjin Institute for Drug Control, Tianjin 300070, China)

机构地区：[1]天津市药品检验研究院,天津300070

出　　处：《中国药品标准》2019年第2期115-118,共4页Drug Standards of China

摘　　要：历版《中华人民共和国药典》(以下简称《中国药典》)均客观地反映了不同历史时期我国医药产业和临床用药的水平^([1]),其也为国家评价药品质量和监管执法提供了法定的依据。随着科技的进步,药品的研发生产、质量提升都有着显著的变化,药典也在不断地修订升级以新版本弥补旧版本,诸如标准缺失、落后等问题^([2])。近年来生物制品成为了疾病治疗的新热点,广泛应用于临床。《中国药典》三部是针对生物制品撰写的质量标准,但在微生物的相关检验方法上与欧美国家的药典尚有差距。故《中国药典》三部在不断地结合生物制品特点进行着修订与编制,以完善国家标准体系,强化质量标准的科学性与先进性^([3,4])。本文将《欧洲药典》(9.2)2.6.27.细胞制品的微生物检查^([5])章节译出,以期为生物制品的安全性检查和新版药典修订提供参考。The all editions of"Pharmacopoeia of the People’s Republic of China" has objectively reflected the development of China’s pharmaceutical industry and medicines for clinical use in different historical periods. It also provides a statutory basis for the state to evaluate drug quality and regulatory enforcement. With the advancement of science and technology,pharmaceutical research and development,and production quality control have significantly changed,thus the " Pharmacopoeia of the People’s Republic of China" is often revised and upgraded to the new edition to compensate for the lack of standards and backward standards etc in the old edition.In recent years,biological products have attracted attention,and been widely used in clinic. As the national standard of biopharmaceuticals,the third volume of "Pharmacopoeia of the People’s Republic of China"currently has a certain gap with the European and American Pharmacopoeia in certain microbial technology requirements,which requires further improvement to strengthen the scientific and advanced quality standards. This article is a full-text translation of the European Pharmacopoeia( 9. 2) 2. 6. 27. Microbiological examination of cell preparations,in order to provide reference for the quality control of biological products and the revision of the new Pharmacopoeia.

关 键 词：欧洲药典 细胞制品 微生物检查 

分 类 号：R921.2[医药卫生—药学]