二氢吡啶类药物杂质研究概述

杂质影响药物的稳定性和质量，降低疗效，并带来可能的毒副作用，分析并控制杂质含量对保证药物质量和用药安全十分重要，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。本文以临床抗高血压一线用药二氢吡啶类药物为例，讨论了杂质研究所涉及的杂质来源、检测方法、杂质限度以及评价标准等相关内容，并对可能出现的问题提出了解决建议，为药物的杂质研究提供参考。

Pharmaceutical impurities affect the stability and quality of the drug,reduce the efficacy,and even cause adverse effects on the human body. Therefore,the impurity investigation is critical to ensure the quality and effectivity of drugs,and is an important part for the novel drug development and generic product consistency evaluation. In this paper,the impurities of dihydropyridine derivates,as an example,were discussed on the sources,determinations,limits and evaluation criteria. And feasible suggestions were given for potential problems. This paper could provide a reference for impurity studies.