抗感染药物杂质对照品的研发策略与展望

摘要：杂质研究是药品质量控制的热点，也是当前药品注册审评审批中所关注的重点。随着药物分析、检测技术的提高， 药品质量标准中对杂质的控制水平也不断提高，进而对杂质分析中特定杂质的定位、定量以及复杂分析方法的转移、评价提出 了新的挑战。采用适宜的杂质对照品可以较好地解决上述难题。本文以杂质或组分相对复杂的抗感染药物为例，重点介绍了中 检院通过研制特定杂质对照品和混合杂质对照品，尝试解决上述问题的思路，提出杂质对照品的研发策略，并阐述目前存在的 问题和今后的发展方向。

Research and development strategy and prospect of anti-infective drug impurity reference substance

Abstract Impurity research is a hot topic in drug quality control and also the focus of attention in the current drug registration review and approval. With the improvement of drug analysis and detection technology, the control level of impurities in drug quality standards is continuously improved, which poses new challenges to the positioning and quantitation of specific impurities in impurity analysis as well as the transfer and evaluation of complex analysis methods. The above problems can be well solved by using appropriate impurity reference substances. Taking antiinfective drugs with relatively complicated impurities or components as an example, this paper mainly introduces the strategy of solving the above problems by developing specific impurity reference substances and mixed impurity reference substances in NIFDC. It puts forward the research and development strategy of impurity reference substances. In addition, it expounds the existing problems and future development