清肝调脂丸质量控制研究

Study on Quality Control of Qinggantiaozhi Pill

目的建立清肝调脂丸的质量控制方法。方法采用薄层色谱法对清肝调脂丸中柴胡、黄芩、丹参进行定性鉴别,采用化学法对郁李仁进行定性鉴别,采用高效液相色谱法测定丹参中丹参酮ⅡA的含量。结果丹参酮ⅡA进样量在0.036～0.096μg范围内与峰面积线性关系良好(r=0.99998),平均回收率为97.4%,RSD=0.96%。结论所用方法重现性好,能有效控制清肝调脂丸的质量。

Objective： To establish a method for the quality control of Qinggantiaozhi pill. Methods Three main Chinese herbal components of Qinggantiaozhi pill were identified by TLC. Then, Yuliren was identified by the certain chemical method. Finally, the content of tanshinone ⅡA in Radix Salviae Mihiorrhizae was determined by HPLC. Results Tanshinone ⅡA showed a good linearity in a range of 0. 036-0. 096 μg （r=0. 999 98）, and the average recovery rate was 97.4%, RSD = 0. 96%. Conclusion This method has a good recurrence and can be used to control the quality of Qinggantiaozhi pill.