中国药典2015年版大环内酯类抗生素的拟增修订重点

The keypoints of proposed supplement and revision to macrolide antibiotics in the Chinese Pharmacopoeia 2015 Edition

中国药典2020年版的增修订工作已经启动。本文针对大环内酯类抗生素的特点,在进一步解读中国药典2015年版变化的基础上,提出对其进一步进行修订的重点。鉴于大环内酯类抗生素具有组分/杂质谱复杂之特点,增修订中应关注对大环内酯类抗生素中组分/有关物质,特别是与工艺相关的特定杂质的控制;而开发具有高专属性的HPLC方法,保证分析方法具有理想的重复性和粗放性,方便地实现对样本中各组分/杂质的快速定位,仍是方法学研究的重点。

The supplement and revision of Chinese Pharmacopoeia 2020 Edition has been started. In this paper, the future keypoints of revising macrolide antibiotics are introduced, on the basis of summarizing the characteristics of macrolides and further interpretation of changes in Chinese Pharmacopoeia 2015 Edition. In view of the complex components/impurity profile of macrolides, the supplement and revision work should be focused on the control of components/related substances, especially those which are process-related. Therefore, the development of HPLC methods with high specificity, desired repeatability robustness, and the capacity of identifying various components/ impurities rapidly is still the key point of future methodology research.