《中华人民共和国药典(2015年版)》(四部)中微生物检验相关通则的增、修订情况介绍
摘 要 目的:介绍《中华人民共和国药典(2015年版)》(四部)中微生物检验相关通则的主要增、修订情况。方法:比较本版和前版药典相关内容的主要差异。结果:本版药典中微生物检验相关通则体现了新的检验理念,在检验技术、检验方法、环境设施、培养体系和质量管理等方面均进行了增、修订。结论:本版药典中微生物检验相关通则更趋完善,已与国际全面接轨。
关键词 《中华人民共和国药典(2015年版)》 微生物检验 通则 增、修订
中图分类号:R921.2 文献标识码:C 文章编号:1006-1533(2016)07-0011-05
An introduction to the revision of microbiological test in the general principle of the Pharmacopoeia of the People’s Republic of China (2015 version) volume IV
FENG Zhen*, FAN Yiling, YANG Meicheng**
(Division of Antibiotics, Shanghai Institute for Food and Drug Control, Shanghai 201203, China)
ABSTRACT Objective: To systematically introduce major supplement and revision in the general principle of the Pharmacopoeia of the People’s Republic of China (Chinese Pharmacopoeia) (2015 version) volume IV. Methods: The main differences between Chinese Pharmacopoeia (2010 version) and Chinese Pharmacopoeia (2015 version) were compared. Results: New ideas in microbiological test were established in Chinese Pharmacopoeia (2015 version), and supplement and updating amendment were carried out in testing technology and methods, environmental facilities, culture media and quality management. Conclusion: The general principle related to microbiological test in Chinese Pharmacopoeia (2015 version) is tending to be perfect and has achieved the international pharmaceutical standard.
KEY WORDS Pharmacopoeia of the People’s Republic of China (2015 version); microbiological testing; general principle; revision
微生物污染是影响药品质量和安全性的主要因素之一。《中华人民共和...
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