藏药十味乳香胶囊质量标准研究

Studies on Quality Standard of SHIWEIRUXIANG Capsule

目的:提高十味乳香胶囊质量标准。方法:采用薄层色谱法对处方中诃子和毛诃子进行定性鉴别;采用高效液相色谱法测定大黄酚的含量,使用FNG Redclassical C_(18)柱(250 mm×4.6 mm,5μm);以甲醇-0.1%磷酸溶液(80∶20)为流动相;流速为1.0 m L·min^(-1);检测波长为254 nm。结果:薄层色谱斑点清晰,阴性无干扰。大黄酚在0.100 8~1.008μg有良好的线性关系(r=0.999 7),平均加样回收率为99.02%(n=6),RSD为1.91%。结论:建立的方法准确、可靠、重复性好,可用于该制剂的质量控制。

Objective： To improve the quality standard of SHIWEIRUXIANG Capsule. Methods： The TLC method was used to qualitatively identify Fructus of Terminalia chebula and T. billericae. HPLC was used to determine chrysophanol. Results： Thin layer chromatograms were clear with good specificity, and no interfere was observed in negative TLC chromatogram. The calibration curve of chrysophanol was linear in the range of 0. 100 8-1. 008 μg （ r = 0. 999 7 ）, The average recovery was 99.02%, RSD was 1.91%. Conclusion： The established methods were accurate, reliable, reproducible and can be used for the quality control of SHIWEIRUXIANG Capsule.