人胰岛素及其类似物国家标准增修订概况  

Updates and amendments of monographs for human insulin and its analogues

作　　者：梁成罡[1] 张慧[1] 丁晓丽[1] 李晶[1] 吕萍[1] 李湛军[1] LIANG Chenggang;ZHANG Hui;DING Xiaoli;LI Jing;LÜPing;LI Zhanjun(Division of Hormone,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院激素室,北京102629

出　　处：《中国药品标准》2022年第3期253-257,共5页Drug Standards of China

基　　金：国家科技重大专项课题资助项目(2018ZX09101001-003-004);2016年药品标准提高项目(392-402)。

摘　　要：本文介绍了2020年版(三部)人胰岛素及其类似物国家标准增修订概况,包括标准起草过程的基本原则和技术考量,并就关键项目在中国药典、欧洲药典和美国药典的协调性方面进行了分析,旨在为本领域内相关研发和质控人员更好地理解和使用人胰岛素及其类似物药典标准提供参考。This paper introduced the updates and amendments of monographs for human insulin and its analogues which were described in the Chinese Pharmacopoeia 2020 VolumeⅢ.The basic principles and technical considerations involved in the process of such draft documents were described.Meanwhile,some key items were discussed in terms of harmonization among the Chinese Pharmacopoeia,European Pharmacopoeia and the United States Pharmacopoeia.It aims to provide reference for relevant R&D and quality control personnel in this field to better understand and use the pharmacopeia standards of human insulin and its analogues.

关 键 词：人胰岛素 人胰岛素类似物 国家标准 药典各论 质量控制 

分 类 号：R921.2[医药卫生—药学]