摘要
结合盐酸阿托莫西汀原料药的合成路线以及可能存在的降解路径,对盐酸阿托莫西汀的有关物质进行了全面剖析。在此基础上,从杂质的结构入手,针对同分异构体难以分离难题,采用不同分析策略对盐酸阿托莫西汀有关物质国内外的研究进展进行了归纳,为盐酸阿托莫西汀原料药及其制剂的有关物质的质量控制提供全面可靠的技术支撑,提高儿童用药安全性。
The impurity profile of Atomoxetine Hydrochloride was comprehensively explored according to the synthetic route and possible degradation pathway.And on this basis,the domestic and foreign research progress of related substances of Atomoxetine Hydrochloride was summarized with different analytical schemes,starting from the impurity profile idea and the structure of impurities,in order to resolve the difficult separation of isomers.The comprehensive and reliable technical support for the quality control of Atomoxetine Hydrochloride and its preparation was provided in order to ensure the safety of drug use for children.
作者
李树英
倪志伟
张庆
卢大峰
臧淑超
王玉玲
翟光喜
LI Shuying;NI Zhiwei;ZHANG Qing;LU Dafeng;ZANG Shuchao;WANG Yuling;ZHAI Guangxi(School of Pharmaceutical Sciences,Shandong University,Jinan 250012,China;Qingdao Double Whale Pharmaceutical Co.,Ltd.,Qingdao 266000,China)
出处
《药学研究》
CAS
2022年第6期400-405,共6页
Journal of Pharmaceutical Research
基金
国家“重大新药创制”科技重大专项资助项目(No.2018ZX09721003-002-004)。
关键词
盐酸阿托莫西汀
有关物质
有机杂质谱
研究进展
Atomoxitine Hydrochloride
Related substances
Impurity profile
Research progress
