补肾消石颗粒质量标准研究

Study on Quality Standard for Bushenxiaoshi Granules

目的:建立补肾消石颗粒的质量标准。方法:采用薄层色谱(TLC)法,对处方中的元胡、泽泻、山药进行定性鉴别;采用薄层色谱扫描法测定延胡索乙素的含量。结果:在TLC中均能检出元胡、泽泻、山药的特征斑点;延胡索乙素进样量在0.408～2.04μg范围内线性关系良好(r=0.9975),平均回收率为95.94%(RSD=1.85%)。结论:所建标准可用于该制剂的质量控制。

OBJECTIVE： To establish the standard for quality control of Bushenxiaoshi granules. METHODS： TLC was applied to identify the properties of Rhizoma Corydalis, Rhizoma Alismatis and Rhizoma Dioscoreae;TLC scanning method was applied to determine the content of Tetrahydropalmatine in Bushenxiaoshi granules.RESULTS：The three herbs could be identified by TLC.There was a good linear relationship with Tetrahydropalmatine at the range of 0. 408- 2. 04μg（ r = 0.997 5）, and the average recovery is 95.94% （RSD= 1.85% ） . CONCLUSION： The methods could be used for quality control of Bushenxiaoshi granules.