国际药典第九版概况及增修订要点回顾  

Overview of the Ninth Edition of the International Pharmacopoeia and the Main Parts of Additions and Revisions

作　　者：蔡丹宁 何开勇 孙春艳 Cai Danning;He Kaiyong;Sun Chunyan(Hubei Institute of Drug Control,Wuhan 430075,China)

机构地区：[1]湖北省药品监督检验研究院,武汉430075

出　　处：《中国药事》2020年第12期1440-1444,共5页Chinese Pharmaceutical Affairs

摘　　要：《国际药典》由世界卫生组织编纂出版,收载原料药、辅料和制剂在全球范围内广泛协调的质量标准及其检验方法,供成员国参考使用。本文介绍了2019年第九版《国际药典》的基本情况,并对《国际药典》2016-2019年的增修订情况进行了回顾总结,以期为我国标准工作提供参考。The International Pharmacopoeia was compiled and published by the World Health Organization. It has collected wide and globally-coordinated quality specifications for pharmaceutical substances, excipients and preparations and serves as references for all member states. This article is to provide an overview of the ninth edition of the International Pharmacopoeia published in 2019 and to review and summarize the main parts of additions and revisions made from 2016 to 2019 so as to provide references for the work on domestic specifications.

关 键 词：国际药典 质量标准 检验方法 

分 类 号：R95[医药卫生—药学]