胆石通胶囊质量控制方法研究

Study on Quality Control Method of Danshitong Capsules

目的探讨控制胆石通胶囊质量标准的方法。方法采用高效液相色谱法(HPLC)检测供试品溶液与对照品的大黄素和大黄酚,分析线性关系、重复性、精密性及回收率。结果 HPLC重复性良好,RSD分别为2.01%和1.80%;精密性检测结果显示大黄素平均(1.526±0.26)mg/g,大黄酚平均(2.235±0.89)mg/g,RSD分别为3.89%和1.56%。大黄素和大黄酚的回收率分别为101.21%、100.45%,RSD分别为0.51%、0.28%。结论 HPLC可以作为胆石通胶囊质量控制的方法。

Objective To explore the method of quality control standard for Danshitong Capsules. Methods High performance liquid chromatography(HPLC)was used to determine the linear relationship,repeatability,precision and recovery of emodin and chrysophanol in the test solution and the control. Results The repeatability of HPLC was good,RSD was 2.01% and 1.80%,respectively. The results showed that the average of emodin and chrysophanol were 1.526±0.26 mg/g and 2.235±0.89 mg/g,with RSD of 3.89% and 1.56%,respectively. The recoveries of emodin and chrysophanol were 101.21% and 100.45%,respectively,with RSD of 0.51% and 0.28%,respectively. ConclusionHPLC can be used as a method for the quality control of Danshitory Capsules.