健肠止泻合剂的质量标准研究

Study on quality standard of Jianchang Zhixie Mixture

目的:建立健肠止泻合剂的质量标准。方法:采用薄层色谱法对健肠止泻合剂中的白芍、陈皮、黄连进行定性鉴别;采用高效液相色谱法对健肠止泻合剂中芍药苷、橙皮苷含量进行测定,色谱柱为Cosmosil C18(250 mm×4.6 mm,5μm),以乙腈-0.1%磷酸水溶液为流动相梯度洗脱,双波长法测定芍药苷(230 nm)、橙皮苷(283 nm),流速1.0 mL/min,柱温30℃。按药典方法测定盐酸小檗碱含量。结果:供试品薄层色谱中均与白芍、陈皮、黄连的对照药材及其相应对照品显示相同颜色斑点或荧光斑点。芍药苷、橙皮苷、盐酸小檗碱在各自范围内线性关系良好(r≥0.9999),平均加样回收率98.12%~98.99%。结论:薄层色谱法鉴别与含量测定方法准确简便,重复性好,可用于健肠止泻合剂的质量控制。

Objective:To establish the quality standard for Jianchang Zhixie Mixture.Methods:Thin layer chromatography(TLC)was used for qualitative identification of Paeonia lactiflora Pall,Aurantii Immaturus Fructus,Coptis chinensis Franch in Jianchang Zhixie Mixture.High performance liquid chromatography(HPLC)method was used for the content determination of paeoniflorin,hesperidin in Jianchang Zhixie Mixture.Using Cosmosil C18 column(250 mm×4.6 mm,5μm).Paeoniflorin(230 nm)and hesperidin(283 nm)were determined simultaneously by gradient elution with acetonitrile-0.1%phosphoric acid solution,with flow rate 1.0 mL/min at 30℃.The content of berberine hydrochloride was determined by the Chinese Pharmacopoeia method.Results:In TLC,all the tested samples showed the same color spots or fluorescent spots as the control herbs of Paeonia lactiflora Pall,Aurantii Immaturus Fructus,Coptis chinensis Franch and their corresponding reference substance.The linearity of paeoniflorin,hesperidin and berberine hydrochloride in their respective ranges was good(r≥0.9999),and the average recoveries were 98.12%~98.99%.Conclusion:The method for TLC identification and content determination is accurate,simple and reproducible,which can be used for the quality control of Jianchang Zhixie Mixture.