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

对药品杂质谱的控制是保证药品安全有效的重要措施,也是提升国产药品质量的关键环节。自2010年提出实施杂质谱控制的基本策略以来,经近十年持续的努力,国内已经形成了一个比较成熟的药品杂质谱控制体系。笔者曾对2010年之前、2010~2015年间化学药品杂质谱控制的进展进行了综述。2015年以来,该领域在杂质谱控制理念、分析技术及技术应用等方面均得以迅速发展,因此本文综述2015年以来化学药品杂质控制的进展情况,并阐述亟待解决的问题和发展前景。

Impurity profiling is one of the most important activities in both assuring drug safety and improving the quality of domestic drugs.Since the basic strategy of impurity profile control was put forward in 2010,a mature control procedure for impurity profile in drugs has been formed in China after nearly ten years of continuous efforts.The progress in impurity profiling before 2010 and from 2010 to 2015 have been reviewed.Since 2015,the concepts,analytical techniques and the application of these techniques in this field have developed rapidly.As a result,the progress in impurity profiling of chemical drugs since 2015 was reviewed in this paper.And the views on future development of impurity profiling in drugs were also put forward.