芪芨散质量标准的研究

Study on Quality Standard of Qiji Powders

目的:建立芪芨散的质量标准方法:采用TLC法,对处方中的黄芪和当归两味药材进行定性鉴别;采用HPLC法,Diamonsil C_(18)色谱柱(150 mm×4.6 mm,5μm),以甲醇-水-磷酸(54:46:0.6,用三乙胺调节pH 6.0)进行洗脱,在280 nm处测定芪芨散中延胡索乙素的含量。结果:在薄层色谱中均能检测出黄芪和当归的成分,空白对照无干扰;延胡索乙素在5.97～59.70μg·ml^(-1)范围内质量浓度与峰面积呈良好的线性关系,平均回收率为100.1%(RSD=1.68%,n=9)。结论:建立的方法准确度高、重复性好,可作为芪芨散的质量控制方法。

Objective： To establish a quality standard of Qiji powders. Method： TLC was used to identify the two herbal plants of the prescription ：Radix Astragali and Radix Angelicaesinensis. The analysis of tetrahydropalmatine was performed on Diamonsil Cls （150 mm × 4. 6 mm,5 um）column with the mobile phase of methanol-water-phosphoric acid （54： 46： 0. 6, adjusting pH to 6. 0 with triethyl- amine）, and the detection wavelength was 280 nm. Result： Components of the two herbals were detected by TLC without negative inter- ference. The linear calibration curve was obtained within the concentration range of 5.97-59. 70 ug· m1-1. The average recovery of tetra- hydropalmatine was 100. 1% （RSD = 1.68% ,n =9）. Conclusion： The method is precise and reproductive,which can be used to con- trol the quality of Qiji powders.