药物杂质研究中风险控制的几个关键问题_张哲峰.pdf

现代药物与临床 Drugs Clinic 2010 年第 25 卷第 5 期 327 药物杂质研究中风险控制的几个关键问题 张哲峰 （国家食品药品监督管理局药品审评中心，北京 100038 ） 摘 要：目的 分析探讨化学药物杂质研究中风险控制的相关问题。方法 通过分析、归纳杂质研究的目的、内 容及其一般过程，探讨药物杂质研究的基本规律和相关要素。结果 科学的分析方法、严格的杂质限度、严谨的 过程控制是药物杂质研究中风险控制的关键要素。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，确定合理的杂质限度，通过对原辅料的源头控制措施、制备工艺的过程控制措 施、包装材料、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。 关键词：杂质研究；风险控制；杂质限度；质量标准；用药安全 中图分类号：TQ460.6 文献标识码：A 文章编号：1674 - 5515 (2010)- 05 - 0327 - 07 Several key factors in the risk control of drug impurity ZHANG Zhe-feng （Center for Drug Evaluation ，State Food and Drug Administration，Beijing 100038 ，China ） Abstract: Objective To analyze and discuss the related factors in the risk control of chemical drug impurity. Methods The basic rule and related factors of drug impurity control were discussed ，and the purpose, content and general process of the impurity study were analyzed ．Results Scientific analytical method，strict impurity limit and critical process control are the key factors in the risk control of drug impurity ．Conclusion Appropriate analytical method ，reasonable impurity limit ，accurate impurity identification and determination are very important in the control of drug impurity ．In addition ，pharmacological ，toxicological and clinical studies should be combined at the same time ．Through source control measures of raw materials and excipients ，process control measures of preparation process and terminal control measures in packing materials ，storage condition and shelf life ，impurity can be well controlled within safe and reasonable range ． Key words: impurity study ；risk control ；impurity limit ；quality standards ；safety 词源诠释“杂质”是指物质中所夹杂的其他成