来曲唑及来曲唑片药典标准制定研究概述  

Establishment of Chinese pharmacopoeia standards for letrozole and Letrozole Tablets

作　　者：岳志华[1] 王志军[1] 梁键谋 何兰[3] YUE Zhihua;WANG Zhijun;LIANG Jianmou;HE Lan(Chinese Pharmacopoeia Commission,Beijing 100061,China;Zhejiang Institutes for Food and Drug Control,Hangzhou 310052,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]国家药典委员会,北京100061 [2]浙江省食品药品检验研究院,浙江杭州310052 [3]中国食品药品检定研究院,北京102629

出　　处：《药物评价研究》2021年第9期2036-2040,共5页Drug Evaluation Research

摘　　要：来曲唑及来曲唑片为《中国药典》2020年版二部新增品种。有关物质是药品的关键质量属性,此项药典标准的制定对于药品质量控制起到重要作用。重点针对来曲唑有关物质项的标准起草、复核、公示、审核及确定过程进行详细分析,阐明了来曲唑原料药及片剂药典标准制定的思路和过程,同时也为其他药品标准的提升及药典标准制定提供了参考。The Monograph of letrozole and letrozole tablets have been added to the 2020 version of Chinese Pharmacopoeia(VolumeⅡ).The impurities control is the key quality attribute of letrozole,so this paper focused on the drafting,review,publicity,review and determination process of letrozole impurities specification.This paper clarified the ideas and processes of pharmacopoeia standard formulation for letrozole and letrozole Tablets,and also provides a reference of the formulation of the pharmacopoeia standard.

关 键 词：来曲唑 来曲唑片 国家药品标准提高 药典标准建立 质量控制 

分 类 号：R921[医药卫生—药学]