复方仙草颗粒的质量标准研究

Study on the Quality Standard of Compound Xiancao Granules

目的:建立复方仙草颗粒的质量标准。方法:采用显微鉴别、薄层色谱法(TLC)对制剂中大黄、三七进行定性鉴别;采用高效液相色谱法(HPLC)测定制剂中人参皂苷Rb1的含量。结果:显微鉴别中三七特征明显,具有专属性,重现性好。大黄、三七的TLC图斑点清晰,分离度好,阴性对照无干扰。人参皂苷Rb1在1.045~10.45μg范围内线性关系良好(r=0.9999),平均加样回收率为100.02%,RSD=1.45%(n=6)。结论:本法专属性强、灵敏度高、重复性好,可用于复方仙草颗粒的质量控制。

Objective:To establish the quality standard of Compound Xiancao Granules.Method:The identification of rhubarb and notoginseng in the preparation was qualitatively identified by microscopic identification and thin layer chromatography(TLC).The content of ginsenoside Rb1 in the preparation was determined by high performance liquid chromatography(HPLC).Result:The characteristics of notoginseng in microscopic identification were significant,with speciality and good reproducibility.The TLC plots of rhubarb and notoginseng are clear,the resolution is good,and the negative control has no interference.The linear relationship of ginsenoside Rb1 in the range of 1.045~10.45μg was good(r=0.9999),the average recovery was 100.02%,and RSD was 1.45%(n=6).Conclusion:This method has strong specificity,high sensitivity and good repeatability,and can be used for quality control of Compound Xiancao Granules.