糖脂消胶囊质量标准的建立

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。

Study on Quality Standard for Tangzhixiao Capsules

Objective： To establish the quality standard for Tangzhixiao capsules. Methods： The qualitative identification of Salvia miltiorrhiza,Atractylodes and Hawthorn was detected by TLC,and the quantitative determination of salvianolic acid B was determined by HPLC. The HPLC determination was performed on a YMC- Triart C18（ 250 mm × 4. 6 mm,5 μm） column with the mobile phase consisted of acetonitrile-0. 1% phosphoric acid（ 24 ∶ 76） at the flow rate of 1. 0 ml·min^-1,the column temperature was 30℃ and the detection wavelength was set at 286 nm. Results： The TLC spots were fairly clear,and the negative samples showed no interference. The concentration of salvianolic acid B within the range of 0. 012-0. 120 mg·ml-1was linear with peak area（ r = 0. 999 5）,the average recovery was 100. 06% and RSD was 0. 83%（ n = 6）. Conclusion： The method is accurate,reliable and reproducible,which can be used in the quality control of Tangzhixiao capsules.