化学药物复方制剂中杂质的检查与控制

Impurities in Compound Preparation of Chemical Drugs:Examination and Control

简介化学药物复方制剂中杂质的分类,概述国内外对其检查和控制的研究现状,并对我国与美国的药典中杂质检查和控制标准进行比较。归纳性提出复方制剂中杂质的预测和归属方略,综述杂质的检测方法。

The classification of impurities in compound preparation of chemincal drugs was briefly introduced. The current status of examination and control of the impurities at home and abroad was outlined and the requirements on examination and control of the impurities in ChP were compared with those in USP. The strategies on prediction and attribution of the impurities were put forward summatively and the methods for the determination of the impurities were reviewed.