参术康胃胶囊质量标准研究

Quality Standards of Shenzhu Kangwei Capsules

目的:建立参术康胃胶囊的质量标准。方法:采用薄层色谱法对参术康胃胶囊中黄连、苦参、大青叶、延胡索进行定性鉴别;采用高效液相色谱法测定参术康胃胶囊中盐酸小檗碱的含量。结果:苦参、黄连、大青叶、延胡索的薄层色谱斑点清晰、分离效果较好、且无阴性干扰。盐酸小檗碱在0.089 1~0.712 4μg范围内与其峰面积积分值呈良好线性关系(r=0.999 9),平均加样回收率为98.27%,RSD=1.89%(n=6)。结论:该方法简便可行、专属性强、重复性好,可用于参术康胃胶囊的质量控制。

Objective： To establish the quality standards of Shenzhu Kangwei Capsules. Methods： TLC was used to identify Sophorae Flavescentis Radix, Coptidis Rhizoma, Isatidis Folium and Corydalis Rhizoma in Kangwei Capsules qualitatively. The content of Berberine hydrochloride was determined by HPLC. Results： TLC spots of Sophorae Flavescentis Radix, Coptidis Rhizoma, Isatidis Folium and Atractlodis Rhizoma were clear and well separated without interference from negative control. The linear range of Berberine hydrochloride was 0. 089 1 - 0.712 4 μg（ r = 0. 999 9）. Average recovery was 98.27% and RSD = 1.89% （ n = 6）. Conclusions ： The method is simple, accurate, specific and reproducible, which can be used for quality control of Shenzhu Kangwei Capsules.