复方生化颗粒的定性鉴别和含量测定研究

Qualitative identification and quantitative determination of Fufang Shenghua granules

目的提高复方生化颗粒的质量标准。方法采用薄层色谱(TLC)法对处方中的甘草、丹参进行定性鉴别;采用高效液相色谱(HPLC)法鉴别苦杏仁苷;采用HPLC法测定处方中的丹酚酸B含量,色谱柱为Agilent HC-C_(18)(4.6mm×250mm,5μm),流动相为乙腈-0.1%磷酸(23∶77),流速为1.0ml/min,检测波长为286nm,柱温为30℃。结果 TLC斑点清晰,分离度较好,专属性强,阴性对照无干扰;HPLC法定性鉴别更加准确、可靠与客观;丹酚酸B在1.56~49.92μg/ml范围内浓度与峰面积呈良好的线性关系(r=0.999 9),平均回收率为100.07%,RSD为1.61%(n=9)。结论建立的方法准确、可靠,重复性好,可用于复方生化颗粒的质量控制。

Objective To improve quality standard of Fufang Shenghua granules.Methods TLC was used to identify chief components in the preparation, Radix et Rhizoma Glycyrrhizae and Salvia Miltiorrhiza.HPLC was applied to identify Amarogentin and to determine the content of Salvianolic acid B.Salvianolic acid B assay was performed on Agilent HC-C18（4.6 mm×250 mm, 5 μm） column with Acetonitrile-0.1% phosphoric acid （23∶77）as mobile phase.The flow rate was 1.0 ml/min.The column temperature was 30 ℃.The detection wavelength was set at 286 nm.Results The spots on TLC were fairly clear with good separation.There was no interference from the negative control samples.However, HPLC was a more accurate, reliable and objective method for qualitative identification.Salvianolic acid B showed a good linear correlation in the range of 1.56-49.92 μg/ml （r=0.999 9）.The average recovery was 100.07%, RSD 1.61% （n=9）.Conclusion A simple, accurate and reliable method was developed for the quality control of Fufang Shenghua granules.