药物残留溶剂的监控及其分析方法

Regulations of residual solvents in pharmaceuticals and advances in the research of its analytical methods

当药品中所含的残留溶剂水平高于安全值时,对人体或环境将产生危害。对残留溶剂的控制已越来越受到人们的关注。本文详细介绍了各国药典对残留溶剂控制标准的沿革、残留溶剂分析方法的沿革,并对近年来残留溶剂分析方法的新进展进行了综述。最后,作者根据本课题组的相关研究成果,对残留溶剂测定专家系统的应用前景进行了展望。

If the presence of residual solvents in pharmaceuticals exceeds tolerance limits as suggested by safety data,they may be harmful to the human body or the environment.It is because of this that the determination of residual solvents receives a great deal of attention.This paper reviews in detail the changes in the regulations on residual solvents in pharmaceuticals in leading pharmacopoeias,and the advances in the techniques involved,especially,the recent advances in the analytical techniques are summarized.At the end,the authors introduce the prospect of the expert system for determining residual solvents in pharmaceuticals based on the studies of their research group.