《中国药典》水分活度在非无菌产品微生物控制中的应用指导原则标准的增订

《中国药典》2020年版“水分活度在非无菌产品微生物控制中的应用指导原则”标准的增订依托药典委员会2017标准提高课题15展开。本文从指导原则的制定背景、研究思路、主要内容、相关说明和应用展望等5个方面综合介绍标准的制订过程。新增订的“水分活度在非无菌产品微生物控制中的应用指导原则”标准将为药品的微生物过程控制提供有力工具,是对当前药品微生物检测和控制体系的重要补充,对于推动我国药品微生物过程控制,进一步实现药品质量控制的科学化、合理化、国际化具有重要意义。

Revision of the guideline standard for the application of water activity in the microbial control of non-sterile products in Chinese PharmacopoeiaLI Hui1,SONG Lin2,MA Shi-hong3,ZHANG Yue-hua4,SHENG Jin-fang 5*

The newly revised standard of "Application of water activity determination to nonsterile pharmaceutical products" in the Chinese Pharmacopoeia 2020 edition was carried out based on the standard improvement topic 15 of Pharmacopoeia Committee in 2017. The paper introduces the formulation process of the standard from five aspects: the background of the formulation of the standard, the research idea, the main content, the relevant explanation and the application prospect. The newly revised " Application of water activity determination to nonsterile pharmaceutical products " standard will provide a powerful tool for microbial process control of nonsterile pharmaceutical products , is the important supplement of the current pharmaceutical microbial test and control system, to promote Chinese pharmaceutical microbial process control, to further implement the drug quality control to be scientific, rationalization, internationalization is of great significance.