化学药品杂质谱控制的现状与展望

Current situation and the trend in impurity profiling of chemical drugs

对药物杂质谱的控制是保证药品用药安全的重要环节,也是促进国内新药研发的关键因素。在国家重大新药创制专项的支持下,十二五期间国内杂质谱控制技术得以迅速发展,已经针对杂质谱控制中的关键技术问题:复杂体系样本的分离分析、微量组分的结构分析和微量组分的毒性评价,形成了基本解决方案,并在应用中取得重大进展。本文综述2010年以来化学药品杂质控制的进展情况,并就今后的发展提出自己的观点。

The safety of medication therapy is closely related to the quality of drugs. Impurity profiling has become the most important activity in assuring the high quality of drugs; meanwhile,it is the key factor for promoting the domestic new drug research and development. Supported by the National Key New Drug RD Program during the 12 th Five Year Plan of state in China,the techniques used in impurity profiling with emphasis on impurity determination,identification as well as qualification have been developing rapidly and made great progress in the application. The progress in impurity profiling of chemical drugs since 2010 was reviewed and the trend of this field in China was outlined.