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目的:建立益心舒胶囊质量控制方法。方法:采用薄层色谱法对人参、丹参、五味子和黄芪进行定性鉴别;用高效液相色谱法对人参皂苷Rg1,Re进行含量测定,采用Merk RP-C18(4.6 mm×250 mm,5μm)色谱柱,乙腈-0.05%磷酸溶液(20∶80)为流动相,检测波长203 nm。结果:本品定性鉴别薄层色谱斑点清晰,专属性强,易于识别;人参皂苷Rg1在进样量为0.399 2～3.992 0μg呈良好的线性关系(r=0.999 9),人参皂苷Re在进样量为0.395 6～3.956 0μg呈良好的线性关系(r=0.999 9);人参皂苷Rg1、人参皂苷Re加样回收率平均达99.6%,RSD 1.9%。结论:该方法准确灵敏、简便、重复性好,提高后的质量标准能更有效的控制益心舒胶囊的质量。
Objective: To establish Yixinshu capsule quality control method. Methods: Ginseng, Radix Salviae Miltiorrhizae, Schisandra chinensis and Astragalus membranaceus were identified by TLC. The contents of ginsenoside Rg1 and Re were determined by HPLC. Merk RP-C18 (4.6 mm × 250 mm, 5 μm) Column, acetonitrile-0.05% phosphoric acid solution (20:80) as the mobile phase, detection wavelength of 203 nm. Results: The TLC identification of the product was clear, specific and easy to identify. Ginsenoside Rg1 showed a good linearity (r = 0.999 9) when the injection volume was 0.399 2 ~ 3.992 0 μg, The linear range was 0.395 6 ~ 3.956 0 μg (r = 0.999 9). The recoveries of ginsenoside Rg1 and ginsenoside Re were 99.6% and 1.9%, respectively. Conclusion: The method is accurate, sensitive, simple and reproducible. The improved quality standard can effectively control the quality of Yixinshu capsule.