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目的提高完善中药制剂茵栀消黄丸的质量标准。方法在原标准的基础上增订了茵陈的显微鉴别;采用薄层色谱法对大黄、栀子、枳实进行鉴别;采用高效液相色谱法测定栀子中栀子苷的含量,色谱柱为Agilent C18(4.6 mm×250 mm,5μm);流动相为乙腈-水(11∶89);流速1.0 m L/min;检测波长为238 nm;柱温35℃;进样体积10μL。结果显微鉴别特征明显,易于辨别;薄层色谱斑点清晰,分离效果良好,阴性对照无干扰;栀子苷在0.010 56~0.105 6 mg/m L浓度范围内线性关系良好,r=1.000 0,平均加样回收率为100.9%,RSD值为0.8%(n=6)。结论该方法简便,可靠,准确,专属性强,可用于该制剂的质量控制。
Objective To improve the quality of traditional Chinese medicine preparation Yinzhi Xiaoyu Pills. Methods The microscopic identification of capillaris was added on the basis of the original standard. The identification of rhubarb, gardenia and citrus aurantium by TLC was carried out. The content of geniposide in gardenia was determined by high performance liquid chromatography (HPLC) Agilent C18 (4.6 mm × 250 mm, 5 μm). The mobile phase was acetonitrile-water (11:89). The flow rate was 1.0 mL / min. The detection wavelength was 238 nm. The column temperature was 35 ℃ and the injection volume was 10 μL. The results showed that the microscopic identification was obvious and easy to distinguish. The TLC spots were clear, the separation effect was good, and the negative control had no interference. Geniposide had a good linearity in the concentration range of 0.010 56 ~ 0.105 6 mg / mL, r = 1.000 0, The average recovery was 100.9% with RSD of 0.8% (n = 6). Conclusion The method is simple, reliable, accurate and specific and can be used for the quality control of the preparation.