浅析水分活度测定在非无菌制剂微生物控制中的应用

以美国药典（USP）收载的1112章节"水分活度测定在非无菌制剂中的应用"为参考，从水分活度的概念，测定原理与方法、与微生物的关系以及在药品质量控制中的应用、意义、问题和不足等角度，介绍和分析水分活度测定在非无菌制剂中的应用。USP率先将水分活度应用于制药领域微生物控制，代表了非无菌制剂的微生物控制由微生物限度测试逐渐向微生物风险评估下的参数放行转变的发展趋势，其理念更为科学合理，控制方法更为简便灵活。对水分活度的理解和认识有助于推动《中华人民共和国药典》2020年版相关内容的增订与推广。

The application of water activity determination of nonsterile pharmaceutical products which is relative to microbiological control in USP 40 was taken as reference. The application of water activity determination of nonsterile pharmaceutical products was introduced from the concepts of water activity, the principle and method of determination, the relationship with microorganisms, the application, significance, problems and shortcomings and development trends of drug quality control. USP pioneered the microbiological control standards with water activity applications in the pharmaceutical industry, which represents the developing trend of microbial control of non-sterile agents from a comprehensive microbiological limit test to the evolution of parameters under microbial risk assessment. The control method became simpler and more flexible. The idea became more scientific and reasonable. Exploring and understanding knowledge of water activity will help to promote the revision and development of relevant content of Pharmacopoeia of the People's Republic of China 2020 edition.