清咽利喉片的质量标准研究

Study on quality standard for Qingyan Lihou buccal tablets

目的：研究清咽利喉片的质量控制标准。方法：采用薄层色谱法鉴别方中的厚朴和玄参,采用高效液相色谱法测定方中君药金银花主要有效成分绿原酸的含量。结果：薄层色谱分离清晰,阴性无干扰。定量方法简便、准确,绿原酸在0.198~1.98μg范围内呈良好的线性关系,平均回收率为99.65%,RSD为1.84%。结论：所建立方法专属性强,灵敏度高,重复性好,可用于清咽利喉片的质量控制。

Objective： To study the quality control standard for Qingyan Lihou buccal tablets. Methods： Thin-layer chromatography（ TLC） was used to identify Magnolia officinalis and Radix Scrophulariae in tablets. High-performance liquid chromatography was used to determine the content of chlorogenic acid as the main effective component of the monarch drug（ Lonicera japonica） in the prescription. Results： There were well-defined spots on the TLC,without interference in the negative controls. The method was simple and accurate. Chlorogenic acid showed a good linear relationship between concentration and peak area in the range of 19-396 ng. The average recovery rate was 99. 65 %,and the relative standard deviation was 1. 84 %. Conclusion： The established method has high specificity,high sensitivity,and high repeatability and can be used for the quality control of Qingyan Lihou buccal tablets.