摘要
复方制剂系指含有多个主药成分(≥2个)的制剂,由于其主药成分较多,除了各原料药的杂质和生产贮存过程中产生的杂质外,还包括主药与主药、主药与辅料之间相互作用产生的降解产物。因此,复方制剂的杂质研究相较于单方制剂更为复杂。本文根据实际案例,梳理了复方制剂有关物质研究和产品优化的基本思路。从杂质分析预测、复方制剂有关物质初步检测方法建立、方法优化、杂质谱研究、杂质归属研究、产品优化等各个步骤逐一阐述,为复方制剂基于有关物质研究开展质量优化的整体流程和思路提供参考。
The compound preparation contains more than one APIs,the sources and types of impurities involved are complex and diverse,and the impurity study is more complex than that of the monotherapeutic preparation,including not only the impurities introduced by each API,the deg-radation products produced by each component during preparation and storage,and the degradation products generated by the possible interactions between the APIs,the API and the excipients.This paper aims to sort out the basic ideas of studying related substances and product optimization of compound preparations according to actual cases,including impurity prediction,preliminary analysis method establishment,analysis method optimi-zation,impurity profile study,impurity attribution study and product optimization,in order to provide reference for the quality optimization of com-pound preparations.
作者
唐丽莉
黄慧萍
Tang Lili;Huang Huiping(Fudan University,Shanghai,200433)
出处
《当代化工研究》
CAS
2023年第19期188-190,共3页
Modern Chemical Research
关键词
有关物质
杂质
复方制剂
产品优化
related substance
impurities
compound preparation
product optimization
