加味益气丸定性鉴别与含量测定

Standard of Jiawei Yiqi Pill

目的:提高加味益气丸的质量标准体系。方法:采用薄层色谱法对处方中当归、防己、陈皮进行定性鉴别研究;采用高效液相色谱法对柴胡皂苷a、d进行含量测定研究。结果:薄层色谱斑点清晰,阴性对照无干扰;柴胡皂苷a在0.050 4～0.352 6 g.L-1线性关系良好(r=0.9997),平均回收率96.17%,RSD 0.18%。柴胡皂苷d在0.034 6～0.242 3 g.L-1线性关系良好(r=0.999 3),平均回收率96.22%,RSD 0.16%。结论:建立的薄层色谱法和高效液相色谱法专属性强、准确度高、重复性好,可用于加味益气丸的的质量控制。

Objective：To improve the quality standard of Jiawei Yiqi Pill. Method： The TLC method was used to identify Angelicae Sinensis Radix, Stephaniae Tetrandrae Radix and Citri Reticulatae Pericarpium in prescription. The HPLC method was used to detect the content of saikosaponin A and D in Bupleuri Radix. Result： This TLC method is good in separation, strong in specificity and negative in interference; saikosaponin A was detected in the range from 0.050 4-0.352 6 mg·mL-1 indicating good linear relationship（r=0.999 7）; the mean sample recovery rate was 96.17% and the RSD was 0.18%, and saikosaponin D in the range from 0.034 6 -0.242 3 g·L-1 indicating good linear relationship（r=0.999 3）, the mean sample recovery rate was 96.22% and the RSD 0.16%. Conclusion： The TLC method and HPLC are simple and accurate in operation, high precision and good in reproducibility, and they can be taken as the standard of quality control Jiawei Yiqi Pill.