扶正化瘀胶囊的TLC鉴别和丹酚酸B含量测定方法研究

Study on the methods for the TLC identification and the content determination of salvianolic acid B and other components in Fuzheng Huayu capsules

目的：完善扶正化瘀胶囊的质量标准。方法：建立了其主要组分丹参、桃仁和五味子的薄层层析鉴别方法;采用反相液相色谱法（RP-HPLC）,在C_（18）色谱柱上,以甲醇-乙腈-水-甲酸（30：10：59：1）为流动相,检测波长286 nm,测定了丹酚酸B的含量。结果 ：薄层图谱斑点清晰,空白对照无干扰。丹酚酸B在4.83-145.05μg/ml范围内有较好的线性关系。平均回收率（n=9）为99.33%,RSD为1.76%。结论 ：本方法操作简便、快速,结果可靠,重复性好,可作为该产品的质量控制方法。

Objective： To improve the quality standard for Fuzheng Huayu capsules. Methods： Salviae miltiorrhizaea, Persicae semen, Schisandrae chinensis fructus in these capsules were identified by TLC. The contents of salvianolic acid B were determined by RP-HPLC on a C_（18） column with a mobile phase of methanol-acetonitrile-water-formic acid（30：10：59：1） at wavelength of 286 nm. Results： The spots on TLC were clear and accurate. The standard curve of salvianolic acid B was linear over the range of 4.83～145.05 μg/ml with an average recovery of 99.33%（RSD 1.76%）. Conclusion： The methods are convenient, reliable and accurate for the quality control of Fuzheng Huayu capsules.