核苷类抗病毒药物质量控制研究进展  

Research progress in quality control of nucleoside antiviral drugs

作　　者：黄露 刘博[1,2] 王岩 范慧红[1,2] 张庆生 HUANG Lu;LIU Bo;WANG Yan;FAN Huihong;ZHANG Qingsheng(National Institutes for Food and Drug Control,Beijing 102629,China;NMPA Key Laboratory for Quality Research and Evaluation of Chemical Drugs,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]国家药品监督管理局化学药品质量研究与评价重点实验室,北京102629

出　　处：《中国药物警戒》2022年第6期692-696,共5页Chinese Journal of Pharmacovigilance

基　　金：北京市自然科学基金资助项目(7194337)。

摘　　要：近年来核苷类抗病毒药物呈现出蓬勃发展的态势,其质量控制标准也在不断发展与完善。本研究基于《中华人民共和国药典》2020年版(ChP 2020)、《美国药典》43版(USP 43)、《欧洲药典》10.0版(EP 10.0)、《日本药典》17版(JP 17)等国内外及相关指导原则等参考资料,全面归纳了核苷类抗病毒药物在药典中的收载情况,对常见核苷类抗病毒药物的质量控制方法进行总结,对其鉴别、含量测定、有关物质及遗传毒性杂质等关键质控项目进行全面分析,深入对比并重点阐述有关物质检查这一关键质量属性的质控研究进展,期望为更为精准的核苷类抗病毒药物质量控制方法的研究与开发提供参考。In recent years,nucleoside antiviral drugs have been increasingly developed,and the related quality control standards have also been improved.Based on 2020 edition of Pharmacopeia of people's Republic of China(ChP2020),43 edition of the United States Pharmacopeia(USP43),10.0 edition of European Pharmacopeia(EP10.0),17 edition of Japanese Pharmacopeia(JP17)and relevant domestic and foreign guidelines,the inclusion of nucleoside antiviral drugs in these pharmacopoeias was summarized,while the critical elements of quality control,such as identification,assay and genotoxic impurities,were analyzed in general and related substances in particular so as to provide reference for the research and development of more accurate quality control methods for nucleoside antiviral drugs.

关 键 词：核苷类抗病毒药物 药典 质量控制 鉴别 含量测定 有关物质 遗传毒性杂质 

分 类 号：R917[医药卫生—药物分析学]