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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 the quality control method of Yigangan stone particles. Methods: Atractylodes, Radix Codonopsis, Fructus Lycii and Fructus Corni were qualitatively identified by TLC. The content of icariin was determined by high performance liquid chromatography (HPLC). The chromatographic column was Diamonsil- C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase was acetonitrile-water (25:75). The flow rate was 1.0 mL · min-1. The detection wavelength was 270 nm. The results showed that the TLC conditions were suitable and the spots were clear. The method of HPLC showed good separation effect and the linearity of icariin in the range of 3.125 ~ 100μg / mL was obtained. The average recovery was 98.42% RSD was 1.61% (n = 6). Conclusion: This method has no interference, accuracy and repeatability and can be used as quality control method of this medicine.