泽泻排石防石颗粒的质量标准研究

Study on Quality Standard of Zexie Paishifangshi Granules

目的建立泽泻排石防石颗粒的质量标准。方法采用薄层色谱法对成品中的广金钱草、桂枝2味中药进行鉴别,采用高效液相色谱法测定成品中的大车前苷的有效成分含量。结果各TLC色谱中,供试品与各自对照品及对照药材色谱相同的位置上显相同颜色的斑点,且阴性对照无干扰。HPLC法测定大车前苷在0.022-0.219 mg/mL范围内线性关系良好（r=0.999 5）,平均加样回收率为100.23%,RSD=0.82%（n=6）。结论本方法具专属性,准确度、重复性好,适用于泽泻排石防石颗粒的质量控制。

OBJECTIVE To establish the quality standard for Zexie paishi fangshi granules. METHODS TLC was used to identify Desmodium styraci fo Lium and Cinnamomum cassia Presl in the granules,and the contents of Plantamajoside were determined by HPLC. RESULTS The characteristic spots of the granules were the same as those of the standard samples without any interference from the negative control. Plantamajoside had a good linear relationship within the range of 0.022-0.219 mg / mL（ r = 0.999 5）,and the average recovery was 100.23% with RSD of 0.82%（ n = 6）. CONCLUSION The method of quality standard is sensitive,accurate,specific and reproducible,which can be used for the quality control of Zexie paishi fangshi granules.