七味红花殊胜丸质量标准研究

Seven Kinds of Safflower Shushen Pill Quality Standards Yesearch

目的：建立七味红花殊胜丸质量标准。方法：采用薄层色谱法（TLC）对处方中红花进行定性鉴别;用高效液相色谱法（HPLC）测定羟基红花黄色素A含量。结果：TLC定性鉴别分离效果好,斑点显色清晰。羟基红花黄色素A的进样浓度在13.18~79.10μg·ml-1范围内与峰面积积分值呈良好线性关系（r=0.9998）;平均回收率为98.2%,RSD=1.27%（n=6）;每丸含红花以羟基红花黄色素A计应不少于1.0mg。结论：标准可用于该制剂的质量控制。

Objective： To establish the quality standard of seven kinds of safflower Shushen pill. Method： By thin layer chromatography （TLC）was used to identify the prescription Honghua;High performance liquid chromatography （HPLC）determination of hydroxysafflor yellow A content. Results：TLC qualitative identification of good separation effect, spot color clear. Sample concentration of hydroxysafflor yellow A in 13.18~79.10μg·ml-1 scope with the peak area values were good linear relationship （r=0.9998）;the average recovery was 98.2%, RSD=1.27%（n=6）;each pill contains safflower to hydroxysafflor yellow A meter shall be not less than 1.0mg. Conclusion：The established standard can be used for the quality control of the preparation.