益肝防石颗粒质量标准研究

Quality Standard of Yigan Fangshi Granule

目的：建立益肝防石颗粒的质量控制方法。方法：采用薄层色谱法（TLC）对方中的白术、党参、枸杞子、山茱萸进行了定性鉴别;采用高效液相色谱法（HPLC）对淫羊藿苷进行了含量测定;色谱柱为Diamonsil-C18柱（250 mm×4.6 mm,5μm）;流动相为乙腈-水（25∶75）;流速为1.0 mL·min-1;检测波长为270 nm。结果：薄层条件适合,斑点清晰;HPLC法定量分离效果好,淫羊藿苷进样浓度在3.125~100μg/mL范围内呈良好的线性关系,r=0.999 8,平均回收率为98.42%,RSD为1.61%（n=6）。结论：该方法无干扰,准确、重复性良好,可作为该药品的质量控制方法。

Objective：To establish a quality control method for Yigan Fangshi Granule. Methods： Rhizoma Atraetylodis Macrocephalae, Radix Codonopsis, lycium chinensis mill and fructus eorni were identified by TLC. HPLC was used to determine ieariin on Diamonsil-C18 （250 mm × 4.6 mm,5 μ m ） column using acetonitrile-water （ 25 ： 75 ） as mobile phase. The flow rate was 1.0 mL · min-1 and the detection wavelength was at 270 nm. Results ： The condition of TLC was suitable and the spots were clear. HPLC had a good separation and there was a good linearity within the range of 3.125-100 μg/mL （r=0.999 8 ）for icariin. The average recovery was 98.42% with RSD of 1.61% （ n=6 ）. Conclusion ： The method is simple, accurate and reproducible. It can he used as the quality control method of Yigan Fangshi Granule.