摘要
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.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2016年第6期1101-1107,共7页
Chinese Journal of Pharmaceutical Analysis
关键词
微生物检查
中国药典2015年版
药典修订
微生物计数法
培养体系
质控理念
microbiological examination
Chinese pharmacopoeia 2015 edition
pharmacopoeia revision
microbial enumeration test
microbial culture system
quality control concept
