桃仁膝康丸质量标准研究

目的建立桃仁膝康丸的质量标准。方法用薄层色谱法对桃仁膝康丸中独活、乳香、白芍、牛膝进行定性鉴别,用高效液相色谱法测定桃仁膝康丸中三七人参皂苷Rg1的含量,采用色谱柱Agilent C18柱（4.6 mm×250 mm,5μm）;流动相：以乙腈为流动相A,水为流动相B,进行梯度洗脱：0-12 min乙腈-水（19∶81）,12-15 min乙腈（19%→20%）,15-18 min乙腈（20%→23%）,18-30 min乙腈（23%→27%）;检测波长为203 nm;流速1.0 mL.min-1;柱温30℃,理论塔板数以人参皂苷Rg1计不低于3000。结果薄层色谱鉴别法能定性鉴别独活、乳香、白芍、牛膝,斑点清晰,分离度好,专属性强,且阴性无干扰。含量测定项中人参皂苷Rg1在2.20-11.01μg间呈良好的线性关系,r=0.999 9;平均加样回收率为99.49%,RSD为1.52%。结论该方法简便、准确、精密度高、重现性好,可作为桃仁膝康丸的质量控制标准。

Research on the Quality Standard of Taoren Xikang Pill

Objective To establish the quality standard of taoren xikang pill.Methods The thin layer chromatography（TLC）was used to identify in quality radix angelicae pubescentis,frankincense,radix paeoniae alba and radix achyranthis bidentatae.The high performance liquid chromatography（HPLC）was adopted to detect the content of ginsenoside Rg1 in radix notoginseng.Color column：Agilent C18（4.6 mm×250 mm,5 μm）.Mobile phase：acetonitrile as mobile phase A,water as mobile phase B.Gradient elution：0-12 min acetonitrile-water（19∶ 81）,12-15 min acetonitrile（19%→20%）,15-18 min acetonitrile（20%→23%）,18-30min acetonitrile（20%→23%）.Detection wavelength：203n.Flow velocity：1.0 mL·min-1.Column temperature：30 ℃.The number of theoretic plate：not less than 3000 for ginsenoside Rg1.Results TLC could identify qualitatively radix angelicae pubescentis,frankincense,radix paeoniae alba and radix achyranthis bidentatae,characterized as explicit dots,good in separation,strong in specificity and negative in interference.Ginsenoside Rg1 was detected in the range from 2.20 to 11.01 μg,indicating good linear relationship,r=-0.999 9.The mean sample recovery rate was 99.48% and RSD was 1.52%.Conclusion This method is simple and accurate in operation,high precision and good in reproducibility.This method can be taken as the standard of quality control for taoren xikang pill.