理脾养胃丸的质量标准研究

Study on Quality Standard of Lipi Yangwei Pills(理脾养胃丸)

目的建立理脾养胃丸质量标准。方法显微鉴别法鉴别砂仁;薄层色谱法(TLC)鉴别白芍和黄芪;高效液相色谱法检测橙皮苷含量,色谱柱为Shimadzu VP-ODS C18(250 mm×4.6 mm,5μm),以甲醇:2%冰醋酸水溶液(35:65)为流动相,流速1.0 ml/min,柱温为30℃,检测波长284 nm。结果显微鉴别特征明显;TLC的色谱斑点清晰,阴性对照无干扰;橙皮苷在0.0442~0.8844μg/ml范围内呈良好的线性关系(r=0.9999),平均回收率100.77%,相对标准偏差(RSD)为0.96%。结论该测定方法简单可行,可用于理脾养胃丸定性、定量检测,可用于理脾养胃丸的质量控制。

Objective To establish quality standard of Lipi Yangwei Pills(理脾养胃丸).Methods Microscopic identification was applied to identify Fructus Amomi Villosi.Thin layer chromatography(TLC)was applied to identify Radix Paeoniae Alba and Radix Astragali seu Hedysari.Hesperidin was determined by high performance liquid chromatography(HPLC).The chromatographic column was Shimadzu VP-ODS C18(250 mm×4.6 mm,5μm).Gradient elution was performed,methanol as mobile phase A and 2%Glacial acetic acid as mobile phase B.The mobile phase was 1.0 mL/min and the column temperature was 30℃.The detection wavelength was 284 nm.Results Characteristics in the microscopic identification were obvious.The TLC spots were clear and the negative control had no interference.Hesperidin showed a good linear relationship in the range of 0.0442 g-0.8844μg/mL(r=0.9999),and the average recovery rate was 100.77%,with relative standard deviation(RSD)of 0.96%.Conclusion The method is simple and available.It can be used for qualitative and quantitative determination,as well as quality control of Lipi Yangwei Pills(理脾养胃丸).