益气健肝颗粒的质量标准研究

目的:建立益气健肝颗粒的质量标准。方法:采用薄层色谱(TLC)法对益气健肝颗粒中的栀子、陈皮、五味子进行定性鉴别;采用高效液相色谱(HPLC)法测定陈皮中橙皮苷的含量:色谱柱为Eclipse XDB-C18(150 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(17∶83,V/V),流速为1.0 ml/min,检测波长为283 nm,柱温为30△。结果:TLC图中,供试品在对照品、对照药材色谱相应位置上显相同颜色的斑点。橙皮苷的质量浓度在0.016⁰.160 mg/ml范围内与其峰面积积分值呈良好的线性关系(r=0.999 7);精密度、稳定性、重复性试验的RSD<2%;平均加样回收率为100.42%,RSD=1.79%(n=9)。结论:所建标准用于益气健肝颗粒的质量控制。

Study on Quality Standard ofYiqi Jiangan Granules

OBJECTIVE：To establish the quality standard of Yiqi jiangan granules. METHODS：Gardenia jasminoides,Citrus reticulata and Schisandra chinensis were qualitatively identified by TLC. The content of hesperidin was determined by HPLC. The determination was performed on Eclipse XDB-C18（150 mm×4.6 mm,5 μm）column with mobile phase consisted of acetonitrile-0.1% phosphate buffer（17∶83,V/V）at the flow rate of 1.0 ml/min. The column temperature was 30 ℃ and the detection wavelength was set at 283 nm. RESULTS：TLC spots of test sample had same color and chromatogram position to substance control and reference substance. The linear range of hesperidin were 0.016-0.160 mg/ml（r=0.9997） with an average recovery of100.42%（RSD=1.79%,n=9）. RSDs of precision,stability and reproducibility tests were all lower than 2%. CONCLUSIONS：The standard is suitable for the quality control of Yiqi jiangan granules.