我国药物研发中杂质研究面临的挑战与思考

目的：分析探讨化学药物杂质研究的基本思路与杂质限度确定的一般原则。方法：通过分析我国药物研发中杂质研究现状和国际上杂质研究发展趋势．阐述杂质研究的目的、内容及其一般过程，探讨其基本规律和相关要素。结果：杂质研究是药品研发中风险控制意识的重要体现．药品中的杂质是否能被全面准确地控制．直接关系到药品的质量可控与安全性。结论：通过选择合适的分析方法，准确分辨与定量杂质．综合药学、毒理学及临床研究的结果．确定杂质的合理限度．通过对起始原料．原料药辅料的源头控制、制备工艺的过程控制、包装材料的优选、贮藏条件及有效期的确立等终端控制措施，将杂质控制在安全合理的范围内．正是杂质研究的最终目的。

Challenge and Considerations for the Impurity Study in the Research and Development of the Drugs in Our Country

Objoetive： Analyze and discuss the basic idea for the impurity study of the chemical drugs and the general principles to determine the impurity limit. Methods： Describe the purpose, content and the general process of the impurity study and discuss the basic law and related essential factors of it through the analysis of the current impurity study status in the research and development of the drugs in our country and the development trend of the intemational impurity study. Results： By the discussion, it is considered that impurity study is the important manifestation for the risk control consciousness in the research and development of the drugs, whether the impurities in the drugs can be controlled completely and accurately is directly related to the quality controllability and safety of the drugs. Conclusions： Distinguish and quantify the impurity accurately, integrate the results of pharmaceutical and toxicological and clinical studies and determine the reasonable limit of the impurity through the selection of the suitable analysis methods and control the impurity within the safe and reasonable limit by the source control of the starting materials, excipients of the APIs, process control of the preparation process, optimal selection of the packing materials and final control measures such as the determination of the storage condition and expiration date is the final purpose of the impurity study.