桃红通脉颗粒质量标准提高研究

Study on improving the quality standard of Taohong Tongmai granule

目的提高桃红通脉颗粒的质量标准。方法采用薄层色谱(TLC)法对赤芍、地黄、甘草进行薄层鉴别,以及采用高效液相色谱法对主药桃仁的有效成分苦杏仁苷进行鉴别;采用高效液相色谱法测定芍药苷的含量,色谱柱为Agilent HCC18柱(250mm×4.6mm,5μm),流动相为乙腈-水(13∶87),流速为1.0ml/min,柱温为30℃,检测波长为230nm。结果赤芍、地黄、甘草的TLC图均斑点清晰,阴性无干扰;芍药苷在1.79~57.28μg/ml范围内浓度与峰面积线性关系良好(r=0.999 9),平均回收率为99.99%,RSD为2.05%(n=9)。结论提高桃红通脉颗粒质量标准后,鉴别方法重现性更好,优化了芍药苷的含量测定方法,增强了成品质量的可控性。

Objective To improve the quality standard of Taohong Tongmai granule.Methods TLC was used to make qualitative identification of Paeoniae Radix Rubra,Rehmanniae Radix,Glycyrrhizae Radix;The effective components of the main walnut kernel were identified by HPLC;and HPLC was used to do quantitative determination of Paeoniflorin,the determination was performed on Agilent HC-C18(250 mm×4.6 mm,5μm)column with mobile phase consisted of Acetonitrile-water(13∶87)at the flow rate of 1.0 ml/min,the column temperature was 30 ℃ and the detection wavelength was set at 230 nm.ResultsThese TLC spots were fairly clear,and the blank test showed no interference;The paeoniflorin at the range of 1.79-57.28μg/ml was linear with peak area(r= 0.999 9),its average recovery rate was 99.99% and RSD was 2.05%(n=9).Conclusion The quality standard of Taohong Tongmai granule had been improved,identification method was better reproducibility,the determination method of paeoniflorin content had enhanced the controllability of product quality.