十三味和中丸的质量标准研究

Study on Quality Standard for Shisanwei Hezhong Pills

目的建立十三味和中丸的质量标准。方法采用薄层色谱法(thin layer chromatography,TLC)法鉴别处方中延胡索、白芍、陈皮。采用高效液相色谱法(high performance liquid chromatography,HPLC)测定十三味和中丸中柚皮苷的含量。结果 TLC色谱中分别检出延胡索乙素、芍药苷、橙皮苷,阴性对照无干扰。柚皮苷在44.52～222.60μg/ml范围内与峰面积呈良好的线性关系(r=0.999 9),平均回收率为96.91%,RSD=1.31%(n=6)。结论所建立的TLC和HPLC方法专属性强、灵敏度高、重现性好,可用于十三味和中丸的质量控制。

Objective To establish the quality standard for Shisanwei Hezhong Pills. Methods Rhizome Corydalis, white peony root, and tangerine peel in the prescription were identified by thin-layer chroma tography （TLC）. The content of naringin in Shisanwei Hezhong Pills was determined by high-performance liquid chromatography （HPLC）. Results Corydalis B, paeoniflorin, and hesperidin were detected by TLC, and there was no interference with the constituents in the negative control group. Naringin showed a good linear relationship between concentration and peak area in the range of 44.52-222.60μg/ml （r= 0. 999 9）. The average recovery rate was 96.91%, and the relative standard deviation was 1.31% （n=6）.Conclusion The TLC/HPLC method can be used for quantity control of Shisanwei Hezhong Pills because of its high specificity, high sensitivity, and good repeatability.