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目的:提高并完善清源调脂胶囊的质量标准。方法:采用TLC鉴别法对制剂中菊花、决明子、山楂、熟地4味中药定性鉴别;以HPLC法测定菊花中绿原酸的含量:色谱柱为DIKMA Spursil C_(18)(250×4.6 mm,5μm);流动相选择甲醇-0.2%磷酸(9∶91);流速为1 ml·min~(-1),检测波长为327 nm,进样量20μl。结果:TLC中,各供试品在与对照品或对照药材相应的位置上显相同颜色的斑点,阴性对照无干扰;绿原酸在4.425 2~30.976 4μg·ml~(-1)(r=0.999 9)浓度范围内有良好的线性关系;平均回收率为101.18%,RSD为1.88%(n=6)。结论:提高后的质量标准具有专属性强、准确度高、重复性好的特点,可用于清源调脂胶囊的质量控制。
Objective: To improve and perfect the quality standard of Qingyuan Tiaozhi Capsule. Methods: Chrysanthemum, cassia, hawthorn and Rehmannia glutinosa were identified by TLC. The contents of chlorogenic acid in chrysanthemum were determined by HPLC: The column was DIKMA Spursil C18 (250 × 4.6 mm, 5 μm ). The mobile phase was methanol-0.2% phosphoric acid (9:91), the flow rate was 1 ml · min ~ (-1), the detection wavelength was 327 nm, and the injection volume was 20μl. Results: In TLC, each test sample showed the same color spots at the corresponding position of the reference substance or the reference drug, and the negative control had no interference. Chlorogenic acid was at 4.425 2 ~ 30.976 4 μg · ml -1 (r = 0.999 9). The average recovery was 101.18% with a RSD of 1.88% (n = 6). Conclusion: The improved quality standard has the characteristics of strong specificity, high accuracy and good repeatability, which can be used for the quality control of Qingyuan Tiaozhi Capsule.