复方山豆根合剂质量标准的研究

Quality Standard of Fufang Shandougen Heji

目的建立复方山豆根合剂的质量标准。方法采用TLC法对处方中山豆根、牛蒡子进行鉴别;HPLC法测定牛蒡子中牛蒡苷的含量。结果用TLC法在处方中检出山豆根和牛蒡子;HPLC检测牛蒡苷在19.14~153.12μg·ml^(-1)范围内线性关系良好,r=0.9996,平均加样回收率为103.3%,RSD为1.79%。结论本方法简便可行,专属性强,重复性好,可用于该制剂的质量控制。

Objective To establish a quality standard for Fufang Shandougen Heji. Methods TLC was used for identification of Radix et Rhizaoma Sophorae Tonkinensis and Arctium lappa L. HPLC was used for determination of arctiin. Results Radix et Rhizaoma Sophorae Tonkinensis and Arctium lappa L. were identified by TLC.The content of arctiin was detected by HPLC. The liner range was 19. 14- 153. 12 μg·ml^（-1） and the average recovery was 103. 3% with an RSD of 1. 79%. Conclusion This method is highly specific,simple and efficient,which can be used as an index of quality control.