普拉克索相关杂质的研究进展

Research Progress of Pramipexole Related Impurities

杂质影响药物的质量和稳定性,降低疗效,甚至可能带来毒副作用,分析并控制杂质含量是新药研发和仿制药质量疗效一致性评价的一项重要内容,对保证药物质量和用药安全十分重要。本文以近年来国内外研究文献为基础,对帕金森病治疗药物普拉克索及其制剂相关杂质的来源、种类、合成路线等进行综述,希望为普拉克索杂质的后续研究提供参考,从而将现有的合成方法进一步优化。

Impurities affect the quality and stability of drugs,reduce the efficacy,and even may cause toxic and side effects.Analyzing and controlling the content of impurities is an important part of the consistency evaluation of new drug development and generic drug’s quality and efficacy,and is very important to ensure the drug quality and drug safety.Based on recent domestic and foreign research literature,this paper reviews the sources,types and synthetic routes of Pramipexole and its preparation related impurities,It is hoped to provide reference for the follow-up study of Pramipexole impurities,as so to further optimize the existing synthetic methods.