中药国家药品标准修订技术要求  

Technical Requirements for Revision of National Drug Standards for Traditional Chinese Medicine

作　　者：何轶 翟为民[1] 倪龙[1] 郝博[1] 李浩 杨昭鹏 HE Yi;ZHAI Wei-min;NI Long;HAO Bo;LI Hao;YANG Zhao-peng(Chinese Pharmacopoeia Commission)

机构地区：[1]国家药典委员会

出　　处：《中国食品药品监管》2021年第9期40-43,共4页China Food & Drug Administration Magazine

摘　　要：国家药品标准是药品监管的强制性技术准则和法定依据,其制修订工作一直以来都受到社会各界的广泛关注。本文从中药国家药品标准修订基本原则、起草用样品及对照物质要求、检测方法的选择以及分析方法验证等方面介绍了中药国家药品标准修订的基本技术要求,以期增加社会各界对中药国家药品标准修订工作的了解,促进此项工作的进一步完善和提高。The national drug standards are mandatory technical provisions and legal basis for drug regulation,the drafting and revision of which have always drawn much attention from regulators and industry alike.This article introduces the basic technical requirements for the revision of national drug standards for traditional Chinese medicine(TCM),in terms of underlying principles,requirements for sample collection and reference materials,choice of testing methods and validation of analytical methods.The authors hope to improve industry and public understanding of TCM drug standard revision,and achieve better results with the task.

关 键 词：中药国家药品标准 技术要求 分析方法验证 

分 类 号：TQ65[化学工程—精细化工]