几种沙坦类药物的杂质谱研究现状  

Research progress of sartans' impurity profile

作　　者：蔡鹏俊[1] 李悦[1] 

机构地区：[1]中国医药工业研究总院上海医药工业研究院,创新药物与制药工艺国家重点实验室,上海201203

出　　处：《药物分析杂志》2016年第3期377-405,共29页Chinese Journal of Pharmaceutical Analysis

摘　　要：杂质控制是保证药物安全的需要,沙坦类药物是临床上普遍应用的降压药,作为一类需长期服用的药物,其杂质谱的研究尤为关键。目前,各国药典均有收载部分沙坦类药物,制定了相关的质量标准。沙坦类药物的杂质主要来源于工艺过程和降解过程,贮存和运输条件的影响也会产生杂质。本文汇总了各国药典中沙坦类药物的收载情况及相关的杂质限度,并针对已上市的沙坦类药物,结合具体药物的生产工艺和结构特征,归纳分析了几种沙坦药物的杂质谱,对杂质来源进行归属,为杂质的有效检出,药物的质量控制和工艺优化提供参考。Impurity control is a significant portion in drug therapy for safety and efficacy.Sartans are widely used in clinical application.The study of the impurities of sartans＇,which are the first-line antihypertensive drugs, is particularly critical.So far,the national pharmacopoeia has recorded some sartans and formulated the relevant quality standards.The impurities of sartans mainly come from production and degradation process.Storage and transportation conditions may also produce additional impurities.By combining specific synthetic technology and structures of compounds,the possible impurities could be analyzed.This article summarizes the records of sartans in pharmacopoeias and limits of relevant impurities.Meanwhile,we have established the impurity profiles of marketed sartans and assigned the source of impurities by analyzing the producing process and chemical structures.The study of sartans＇ impurity profiles can provide a reference for effective detection,quality control and process optimization.

关 键 词：沙坦类药物 杂质谱 杂质结构 中间体 副产物 降解杂质 药典规定 

分 类 号：R917[医药卫生—药物分析学]