中国药典2015年版非无菌产品微生物限度检查:微生物计数法解读

目的: 解读中国药典2015 年版非无菌产品微生物限度检查:微生物计数法的主要增修订情况。方法: 对比中国药典2015 年版非无菌产品微生物限度检查:微生物计数法与中国药典2010 年版微生物限度检查法的相关内容的主要差异。结果: 中国药典2015 年版非无菌产品微生物检查计数法在适用范围、检测环境、检测方法、培养体系及质量控制理念等方面都做了较大修订。结论: 中国药典2015 年版将微生物检查计数法完善成为更加科学与国际接轨的检查方法。

Objective: To interpret the main revision situation about microbiological examination of non-sterile products according to the microbial enumeration test of Chinese pharmacopoeia 2015 edition. Methods: The microbiological examination of non-sterile products was compared between the microbial enumeration test of Chinese pharmacopoeia 2015 edition and the relevant content of the 2010 edition. Then,the differences were analyzed. Results: Our results showed that the microbial enumeration test of Chinese pharmacopoeia 2015 edition had been revised at a comparatively large scale in the inspection items,test method,microbial culture system, the quality control concept and so on. Conclusion: Microbial inspection system of Chinese pharmacopoeia 2015 edition were gradually improved,which has become a high standards check system in line with international standards.