国家药品标准物质替诺福韦的研制  

Establishment of national reference substance of tenofovir

作　　者：刘毅[1] 郭贤辉 严菁[1] 林兰[1] LIU Yi;GUO Xian-hui;YAN Jing;LIN Lan(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,北京102629

出　　处：《中国新药杂志》2024年第1期79-82,共4页Chinese Journal of New Drugs

基　　金：中国食品药品检定研究院化学药品检定所重点实验室学科建设项目(2023HYZX25)。

摘　　要：目的:本研究对首批国家药品标准物质替诺福韦进行研发,为相关药品的质量控制提供保障。方法:综合采用紫外光谱、红外光谱、高分辨质谱、核磁共振谱等技术对首批标准物质替诺福韦的结构进行确证;采用质量平衡法赋值标准物质的含量,并应用外标法、容量法等佐证量值的准确性;采用动态水分吸附分析法初步研究了本品的引湿性。结果:首批标准物质替诺福韦的含量为93.8%;引湿性研究显示本品6%的水分含量趋于稳定。结论:建立了首批替诺福韦国家药品标准物质。Objective:To establish the first batch of national reference substance of tenofovir,in order to provide guarantee for quality control of related drugs.Methods:The structure of tenofovir was identified by UV,IR,HRMS,and NMR.The content of tenofovir was determined by mass balance method,and was further verified by external standard method and volumetric method to ensure the accuracy of the quantification.The hygroscopicity of the reference substance was preliminarily studied by dynamic vapor sorption(DVS)analysis.Results:The result of the mass balance method was used as the content of the first batch of national reference substance,and the amount of tenofovir was 93.8%.The hygroscopicity study showed that the 6%moisture content of the reference substance tends to be stable.Conclusion:The first batch of national reference substance of tenofovir was successfully developed.

关 键 词：替诺福韦 国家药品标准物质 引湿性 动态水分吸附 质量平衡法 结构确证 

分 类 号：R917[医药卫生—药物分析学]