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目的:建立参桃软肝胶囊的质量控制标准。方法:采用TLC对该制剂中生晒参、当归、丹参、大黄进行定性鉴别,采用HPLC测定人参皂苷Rb1的含量,色谱条件为以乙腈-水为流动相进行线性梯度洗脱,流速1.0 mL·min-1,检测波长203nm。结果:TCL专属性强,均能检出目标物质,且斑点清晰,阴性对照无干扰。人参皂苷Rb1线性范围0.406～4.059 7μg(r=0.999 7),平均加样回收率100.96%,RSD 1.16%。结论:方法简便准确、重复性好,可有效控制参桃软肝胶囊的质量。
Objective: To establish the quality control standard of Shen Tao Ruangan Capsule. Methods: The crude Radix Ginseng, Radix Angelicae Sinensis, Radix Salviae Miltiorrhizae and Rhubarb were qualitatively identified by TLC. The content of ginsenoside Rb1 was determined by HPLC. The chromatographic conditions were linear gradient elution with acetonitrile-water as mobile phase and the flow rate was 1.0 mL · min-1, detection wavelength of 203nm. Results: The specificity of TCL was high, both of which could detect the target substance, and the spots were clear and the negative control had no interference. Ginsenoside Rb1 linear range of 0.406 ~ 4.059 7μg (r = 0.999 7), the average recovery rate of 100.96%, RSD 1.16%. Conclusion: The method is simple, accurate and reproducible, which can effectively control the quality of Shen Tao Ruan Gan Capsule.