摘要
《中华人民共和国药典》、美国药典(USP)及欧洲药典(EP)等均指出具有抑菌性产品的微生物计数、检测、抑菌效力检查或无菌检查,应首先中和其抑菌性,并需对中和抑菌性的方法进行验证。《美国药典》通则<1227>药品微生物回收的验证首次详细阐释了中和方法验证方案的设计和试验结果的判定,对于完善药品微生物检查方法、保证微生物检测结果准确,具有指导意义。本文将《美国药典》(USP42-NF372S)通则<1227>章节译出,以期为医药界的科研工作者提供参考。
The antimicrobial property should be neutralized firstly and the neutralization method must be validated when the tests of microbial enumeration,specified microorganisms,antimicrobial effectiveness or sterility are performed for antibacterial products as per ChP,USP and EP.The design of validation protocol of neutralization method and the results judgement are described in details in the general notice<1227>(Validation of Microbial Recovery from Pharmacopoeia Articles)of USP for the first time.That has the guidance significance on improving the microbial test method and ensuring the accuracy of results.The general notice<1227>of USP42-NF372S is translated to provide the reference for the researchers in pharmaceutical industry.
作者
解慧
刘洪祥
杨倩
曹晓云
XIE Hui;LIU Hongxiang;YANG Qian;CAO Xiaoyun(Tianjin Institute for Drug Control,Tianjin 300070,China)
出处
《中国药品标准》
CAS
2020年第2期146-149,共4页
Drug Standards of China
关键词
美国药典
微生物回收验证
抑菌性
USP
validation of microbial recovery
antimicrobial property
