《中国药典》2015年版非无菌产品微生物限度检查:控制菌检查法解读与对策

Interpretation and Countermeasure of the Microbiological Examination for Nonsterile Products: Tests for Specified Microorganisms in Chinese Pharmacopoeia( 2015 Edition)

目的:解读《中国药典》2015年版非无菌产品微生物限度检查控制菌检查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控制菌检查法与《中国药典》2010版微生物限度检查法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控制菌检查法在检查内容、检查方法、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年版将微生物限度检查控制菌检查法完善成为更加科学的与国际接轨的检查方法。

Objective： To interpret the main revision of the microbiological examination for nonsterile products： tests for specified microorganisms in Chinese Pharmacopoeia（ 2015 edition）. Methods： The microbiological examination for nonsterile products： tests for specified microorganisms in Chinese Pharmacopoeia（ 2015 edition） was compared with the relevant content in the 2010 edition,and then the differences were investigated. Results： Microbiological examination for nonsterile products： tests for specified microorganisms in 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 in Chinese Pharmacopoeia（ 2015edition） is gradually improved to become a high standard check system in line with the international standards.