通脉颗粒的质量标准研究

Study on the quality standard for Tongmai Granules

目的研究通脉颗粒的质量控制标准。方法通过薄层色谱法(TLC)对通脉颗粒剂处方中的益母草、茵陈和当归3味药材进行定性鉴别;建立通脉颗粒中芍药苷高效液相色谱(HPLC)测定方法。结果在通脉颗粒薄层色谱鉴别中均能检出益母草、茵陈和当归;通脉颗粒高效液相色谱图中芍药苷色谱峰与其他组分峰分离良好,芍药苷质量浓度在3.6~144μg·mL^(-1)范围内线性关系良好,相关系数(r=0.999 8)符合要求,通脉颗粒的样品加样回收率为98.5%,RSD值为1.19%(n=5).结论建立的方法简便可行,该标准可作为通脉颗粒的质量控制方法。

Objective To establish a standard for the quality control of Tongmai Granules.Methods Leonurus japonicus,Artemisia capillaris and Angelica sinensis were identified by TLC,and paeoniae was quantatively analyzed by HPLC.Results The TLC identification methods of Leonurus japonicus,Artemisia capillaris and Angelica sinensis were specific,the calibration curve of paeoniflorin showed a good linear relationship in a range of 3.6-144μg·mL-1（r=0.999 8）,and the average recovery of Tongmai Granules was 98.5%,RSD was 1.19%（n=5）.Conclusion This method is accurate and reproducible,and can be used as the quality standard of Tongmai Granules.