注射用培美曲塞二钠参比制剂解析研究
Analysis of Pemetrexed Disodium for Injection Reference Listed Drug
刘梦婷 1姚彤 2许多 2唐婷婷 1常梦茹 1白玮丽 2高珣1
作者信息
- 1. 江苏海洋大学,江苏 连云港 222005
- 2. 连云港杰瑞药业有限公司,江苏 连云港 222006
- 折叠
摘要
通过文献调研和反向工程实验,对注射用培美曲塞二钠参比制剂进行解析.通过对参比制剂的FDA说明书、EMA及PMDA审评信息的查阅分析,初步得出参比制剂的处方组成等信息;采用高效液相色谱法、2020版中国药典通则等方法,对3批参比制剂的有关物质、含量等关键质量属性进行检测.注射用培美曲塞二钠参比制剂中主要杂质为培美曲塞酮和杂质BC;培美曲塞过量投料8.5%,满足说明书中临床用量不少于100 mg的要求;检测结果均符合中国药典对注射剂的要求.较全面地解析出了注射用培美曲塞二钠参比制剂的处方和关键质量属性,为行业开展一致性评价工作提供参考.
Abstract
To analysis the reference listed drug of Pemetrexed disodium for injection through literature research and reverse engineering experiments.By reviewing and analyzing the FDA instructions,EMA,and PMDA review information of the reference listed drug,the prescription composition and other information of the reference listed drug were preliminarily obtained;methods such as high-performance liquid chromatography and the 2020 edition of the General Principles of the Chinese Pharmacopoeia were used to detect the critical quality attribute of the three batches of reference listed drugs,including related substances etc.,The main impurities in the reference listed drug of Pemetrexed disodium for injection were Pemetrexed ketone and impurity BC;The excessive dosage of Pemetrexed in the reference listed drug is 8.5%,which meets the clinical requirement of not less than 100 mg in the instruction manual;The test results all meet the requirements of the Chinese Pharmacopoeia for injections.The prescriptionand Critical to quality attributes of the listed drug of Pemetrexed disodium for injection were comprehensively analyzed,providing reference for the industry to carry out consistency evaluation.
关键词
注射用培美曲塞二钠/参比制剂/反向工程/一致性评价Key words
pemetrexed disodium for injection/reference listed drug/reverse engineering/consistency evaluation引用本文复制引用
出版年
2024
NETL
NSTL
万方数据