心无忧片质量标准提升研究

Study on the improvement of quality standard of Xinwuyou Tablets

目的建立并提升心无忧片的质量标准。方法采用薄层色谱法对心无忧片中的细辛、茵陈及丹参进行定性鉴别,采用高效液相色谱法测定心无忧片中丹酚酸B的含量。色谱柱为Kromasil C18柱(4.6 mm×250 mm,5μm),流动相为乙腈-0.1%磷酸溶液(25∶75),流速为1.0 mL/min,检测波长为286 nm,柱温为30℃。结果鉴别方法专属性强,定量方法简便、准确,丹酚酸B进样量在0.0735~3.6750μg范围内线性关系良好,相关系数为1.0000;平均回收率为101.20%,RSD为1.05%。结论该方法简便、准确、重复性好,可作为心无忧片的质量标准。

Objective To eastablish and improve the quality standard of Xinwuyou Tablets. Methods Thin-layer chromatography was used to identify Asari Radix et Rhizoma, Artemisiae Scopariae Herba and Salviae Miltiorrhizae Radix et Rhizoma, and high performance liquid chromatography was applied for the determination of salvianolic acid B in Xinwuyou Tablets. Kromasil C18 column (4.6 mm×250 mm, 5 μm) was adopted with a mobile phase of acetonitrile-0.1% phosphoric acid (25∶75) at the flow rate of 1.0 mL/min. The detection wavelength wad set at 286 nm and the column tempetature was 30℃. Results The thin-layer chromatography identification was highly specific. The method of content determination was simple and accurate. The good linearity with peak areas was achieved in the range of 0.0735-3.6750 μg (r = 1.0000) for salvianolic acid B. The average recovery was 101.20% and the RSD was 1.05%. Conclusion The method is simple, accurate and reproducible, and can be used for the quality control of Xinwuyou Tablets.