首页|富马酸丙酚替诺福韦仿制药药学研究的一般考虑

富马酸丙酚替诺福韦仿制药药学研究的一般考虑

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近年来,以富马酸丙酚替诺福韦(tenofovir alafenamide fumarate,TAF)为代表的核苷(酸)类抗乙型肝炎药物仿制药申报获得广泛关注。本文通过对富马酸丙酚替诺福韦的理化性质、合成路线、质量研究、制剂的工艺特点等进行汇总整理,结合相关文献专利和审评经验,综合提出富马酸丙酚替诺福韦(TAF)药学研究的建议,旨在为后续研发提供一些参考。
General considerations for generic pharmaceutical research of tenofovir alafenamide fumarate
In recent years,the application of generic nucleoside(acid)anti hepatitis B drugs represented by tenofovir alafenamide fumarate(TAF)has received widespread attention.This article summarized and organized the physical and chemical properties,synthesis routes,quality studies,and process characteristics of propofol tenofovir fumarate.Combined with relevant literature patents and review experience,suggestions for pharmaceutical research on propofol tenofovir fumarate(TAF)were comprehensively proposed,aiming to provide some reference for subsequent research and development.

Nucleos(t)ide analogues(NAs)Tenofovir alafenamide fumarateGeneric drug

张歆、吴小飞、王宏亮

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国家药品监督管理局药品审评中心,北京 100022

核苷(酸)类抗乙型肝炎药物 富马酸丙酚替诺福韦 仿制药

2024

药学研究
山东省药品检验所 山东省药学会

药学研究

CSTPCD
影响因子:0.653
ISSN:2095-5375
年,卷(期):2024.43(12)