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目的:建立糖脂消胶囊的质量标准。方法:采用薄层色谱法对丹参、白术、山楂进行定性鉴别;采用高效液相色谱法测定丹酚酸B的含量,色谱柱为YMC-Triart C18(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸(24∶76),流速为1.0 ml·min-1,柱温为30℃,检测波长为286 nm。结果:丹参、白术、山楂的薄层色谱图均斑点清晰,阴性无干扰;丹酚酸B在0.012~0.120 mg·ml-1范围内线性关系良好(r=0.999 5),平均回收率为100.06%,RSD为0.83%(n=6)。结论:研究方法准确可靠,重复性好,可用于糖脂消胶囊的质量控制。
Objective: To establish the quality standard of glycolipid capsule. Methods: TLC, TLC and HPLC were used to determine the content of salvianolic acid B. The chromatographic column was YMC-Triart C18 (250 mm × 4.6 mm, 5 μm) with mobile phase Acetonitrile-0.1% phosphoric acid (24:76), the flow rate was 1.0 ml · min-1, the column temperature was 30 ℃ and the detection wavelength was 286 nm. Results: The TLCs of Salvia miltiorrhiza, Atractylodes macrocephala and Crataegus pinnatifida were all clear spots and negative without interference. The linearity of salvianolic acid B in the range of 0.012-0.120 mg · ml-1 was good (r = 0.999 5) and the average recovery was 100.06 %, RSD 0.83% (n = 6). Conclusion: The research method is accurate and reliable with good repeatability and can be used for quality control of glycolipid capsules.