中国药品微生物标准体系的建立与发展  

The establishment and development of China′s pharmaceutical microbiological standard system

作　　者：朱冉 许华玉[1] 张军[1] ZHU Ran;XU Huayu;ZHANG Jun(Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]国家药典委员会,北京100061

出　　处：《中国药品标准》2023年第6期561-566,共6页Drug Standards of China

摘　　要：自1973年起,中国全面开展药品微生物检验工作已经历经五十年。通过不断解决我国药品污染微生物检验、控制的实际问题,总结大量课题研究的规律,充分学习、吸收国际先进经验等,从无到有,建立起了相对完善的中国药品微生物标准体系,成为中国药典的有机组成部分,满足了我国几十年来医药行业质量控制的需求,夯实了未来进一步发展的坚实基础,并将在国家推动制药业高质量发展的战略中发挥重要作用。Since 1973,China has been conducting comprehensive pharmaceutical microbiological testing work for fifty years.Through continuously solving practical problems in pharmaceutical microbiological testing and control in China,conducting extensive research and summarizing rules,and fully learning and absorbing international experience,China has established a relatively complete China′s pharmaceutical microbiological standard system,which has become an essential component of the Chinese Pharmacopoeia and has met the safety control needs of the pharmaceutical industry in China for decades.It has laid a solid foundation for the further development in the future and will continue to play an important role in the national strategy of promoting high-quality development of the pharmaceutical industry.

关 键 词：药品微生物 标准体系 建立 发展 

分 类 号：R921.2[医药卫生—药学]