消石通颗粒质量标准研究

Quality Standard of Xiaoshitong Granules

目的建立消石通颗粒的质量控制方法。方法对方中金钱草、鸡内金和甘草3味药进行薄层色谱(TLC)鉴别,同时采用高效液相色谱(HPLC)法测定制剂所含绿原酸总量。结果TLC色谱图中斑点清晰,专属性强;绿原酸质量浓度在7.12~35.60μg/mL范围内与峰面积线性关系良好,平均回收率为101.29%,RSD为2.29%(n=9)。结论所建立的TLC定性鉴别方法简便、重复性好,定量方法准确、可靠,可作为消石通颗粒的质量标准。

Objective To establish the quality control method of Xiaoshitong Granules.Methods TLC method was used for qualitative identification of the Lysimachia christinae,Gallus gallus domesticus and Radix Glycyrrhizae.HPLC method was used for content determination of the total chlorogenic acid in this preparation.Results TLC spots were clear with strong specificity.The linear relationship of chlorogenic acid content was good in the range of 7.12-35.60μg/m L,the average recovery was 101.29%,RSD was 2.29%(n=9).Conclusion The established TLC qualitative identification method is simple,reproducible,accurate and reliable,which can be used as the quality standard of Xiaoshitong Granules.