药物中有机杂质的控制  

Control of organic impurities in drugs

作　　者：苏佳妍[1] 于大海[2] 马坤[3] 

机构地区：[1]中国医科大学第一临床医院药学部,沈阳110001 [2]辽宁省食品药品检验所,沈阳110023 [3]国家食品药品监督管理局药品审评中心,北京100038

出　　处：《中国新药杂志》2009年第24期2298-2301,2312,共5页Chinese Journal of New Drugs

摘　　要：化学药品在研制过程中,有关物质的定性研究具有重要意义,有关物质是指在药物制备和贮存过程中,根据药物性质和合成方法可能产生的杂质,多指有机杂质,也包括残留溶剂和手性化合物中无特殊毒性的对映体。现对在研制过程中有关物质定性研究的几种方法进行介绍。Qualitative research of related substances is important in the development of medicinal chemicals. Related substance is defined as the impurity that is produced naturally,and during the synthesis of drugs,preparation and storage.Most related substances are organic admixture and residual solvents,and also included non-specific toxic enantiomers of chiral compounds.Here we introduce several methods of qualitative research of related substances in the development of drugs.

关 键 词：有关物质 定性研究 有机杂质 

分 类 号：R95[医药卫生—药学] R927.12