三仙脱力丹质量标准研究

Study on quality standards for Sanxiantuoli pills

目的：建立三仙脱力丹的质量标准。方法：采用薄层色谱法对三仙脱力丹组方中药材五味子、淫羊藿进行定性鉴别;采用高效液相色谱法测定淫羊藿苷的含量,色谱柱为InertSil ODS-SP C_（18）色谱柱（5μm,4.6 mm×250 mm）,流动相为乙腈-水（30∶70）,流速1.0 mL/min,柱温30℃,检测波长270 nm。结果：薄层色谱鉴别斑点清晰,专属性强,阴性对照无干扰;高效液相色谱法测定淫羊藿苷在0.209 6～1.048 0μg呈良好的线性关系（r=0.999 8）,加样回收率为99.43%,RSD为1.84%（n=5）。结论：本研究建立的检测方法既能定性又能定量,操作方法简便,专属性强,重复性好,可作为制剂三仙脱力丹的质量标准。

Objective：To establish quality standards for Sanxiantuoli pills. Methods：Fructus Schinensis and Herba Epimedii in the Sanxiantuoli pills were identified qualitatively by TLC method. The content of icariin was determined by HPLC,InertSil ODS-SP C_（18）（5 μm,4.6 mm × 250 mm）as the chromatogram column,and acetonitrile-water（30∶70）as the mobile phase.The flow rate was 1.0 mL/min;the column temperature was 30 ℃;the detection wavelength was 270 nm. Results：TLC identification showed clear spots with strong specificity and non-interference in negative control. The concentration of icariin that measured by HPLC presented a good linearity in the range of 0.209 6～1.048 μg（r=0.999 8）. The average recovery was99.43%,RSD =1.84%（n =5）. Conclusion：The method in this study was to use for both qualitaty and quantitaty,which was simple,accurate,reliable,exclusive and with good reproducibility. The method could be used for the quality control of Sanxiantuoli pills