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目的建立祛脂胶囊的质量标准。方法采用薄层色谱法(TLC)对山楂、何首乌进行定性鉴别;采用高效液相色谱法(HPLC)测定熊果酸含量,色谱柱为十八烷基硅烷键合硅胶柱,流动相为乙腈-0.5%磷酸溶液(72∶28),流速为1.0ml·min-1,检测波长205nm,柱温40℃。结果 TLC可以鉴别出山楂、何首乌对应的特征斑点,且阴性对照无干扰;采用HPLC法测定熊果酸的线性范围为0.22~2.2μg(r2=0.9994),平均回收率为102.3%,RSD为2.7%(n=6)。结论该方法简便可行、重复性好,可用于祛脂胶囊的质量控制。
Objective To establish the quality standard of Qushi Capsule. Methods TLC and TLC were used to identify hawthorn and fleece-flower root. The content of ursolic acid was determined by high performance liquid chromatography (HPLC). The column was octadecylsilane bonded silica gel column, the mobile phase consisted of acetonitrile - 0.5% phosphoric acid solution (72:28), flow rate 1.0ml · min-1, detection wavelength 205nm, column temperature 40 ℃. TLC and TLC were used to identify the characteristic spots of hawthorn and fleece-flower root, and there was no interference with the negative control. The linear range of ursolic acid was 0.22 ~ 2.2μg (r2 = 0.9994) with the average recovery of 102.3% and RSD of 2.7 % (n = 6). Conclusion The method is simple and feasible with good repeatability and can be used for the quality control of Qushi Capsule.