摘要
药品微生物控制是药品安全性保障的重要措施。从2005年版《中国药典》起,经持续不断的努力,已经形成了一个比较完备的药品微生物控制标准体系;至2015年版《中国药典》,不仅实现了三部药典通则的统一,且解决了《中国药典》与ICH协调案的协调问题,完全实现了与国际标准的接轨。笔者通过对历版《中国药典》主要增修订工作的回顾,揭示了2015年版《中国药典》药品微生物控制体系的形成过程和主要特征,且通过对2015年版《中国药典》增修订工作中热点问题的讨论,明确未来国内药品微生物控制的发展方向。
Microbial control is one of the important parts of drug safety guarantee system. Chinese pharmacopoeia 2015 edition has constructed a complete system for pharmaceutical microbial control after continuous efforts since the 2005 edition. The new edition Chinese pharmacopoeia not only achieves the unity of three parts,but also makes harmonization between Chinese pharmacopoeia and ICH,thus is fully in line with international quality control system. In this paper,the revision progress of the last several editions of Chinese pharmacopoeia is reviewed. The main characteristics of pharmaceutical microbial control system in Chinese pharmacopoeia 2015 edition is clarified by revealing the formation process. The trend of this field in China is outlined by discussion on some hot issues.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2015年第20期1747-1751,共5页
Chinese Pharmaceutical Journal
