单一成分药物有关物质的质量控制研究要点

以紫杉醇及紫杉醇注射液为例,根据《化学药物杂质研究的技术指导原则》,并参考《中国药典》《美国药典》《欧洲药典》《英国药典》,探讨单一成分药物有关物质质量控制研究要点：（1）不同来源（例如天然来源分离、半合成、发酵）单一成分药物的有关物质可能存在差异;（2）不同来源单一成分新药原料药与制剂的有关物质控制侧重点有所不同,新药制剂的有关物质侧重于对降解产物制定限度;（3）4国药典收录的紫杉醇及其注射剂在有关物质的控制上有所区别;（4）4国药典或相关指导原则对有关物质限度的要求基本一致;（5）通过中药注册分类途径申报的,从天然来源分离得到的单一成分药物及制剂需参照中国《化学药物杂质研究的技术指导原则》的相关要求进行研究和控制。

Key points of research on quality control of related substances in single component drugs

In this paper, paclitaxel and Paclitaxel Injection as an example, according to the "Technical Guideline for the Study of Chemical Drug Impurities", and reference to the Chinese Pharmacopoeia, United States Pharmacopoeia, European Pharmacopoeia, British Pharmacopoeia, discuss the single component drug related substances quality control research points:(1) There may be differences in the relevant substances of single component drugs from different sources (such as natural sources, semi-synthetic, fermentation); (2) The control focus of related substances of new drug APIs from different sources with single components is different from that of new drug preparations. Related substances of new drug preparations focus on setting limits of degradation products; (3) There are differences in the control of related substances in paclitaxel and its injections recorded in the pharmacopoeia of four countries; (4) The pharmacopoeias of four countries or relevant guidelines have basically the same requirements for the limits of related substances; (5) Single component medicines and preparations isolated from natural sources that have been declared through the registration and classification of traditional Chinese medicine should be studied and controlled in accordance with the relevant requirements of "Technical Guideline for the Study of Chemical Drug Impurities".