丹郁消癖颗粒质量控制方法研究

Study on Quality Standard of Danyu Xiaopi Granules

目的建立丹郁消癖颗粒的质量控制方法。方法采用薄层色谱法,对丹郁消癖颗粒中益母草、赤芍、青皮、夏枯草、柴胡和皂角刺进行定性鉴别;采用高效液相色谱法,对君药中有效成分丹参素钠进行定量测定。结果益母草、赤芍、青皮、夏枯草、柴胡和皂角刺薄层色谱斑点清晰,分离度好,阴性无干扰;丹参素钠进样量在0.9~4.5μg范围内与峰面积线性关系良好(r=0.999 9),平均加样回收率为97.11%,RSD为2.34%(n=6)。结论该方法简单、准确、重复性好,可用于丹郁消癖颗粒大生产中的质量控制。

Objective To establish the quality standard for Danyu Xiaopi Granules. Methods TLC method was used for qualitative de-termination of Leonurus japonicus, HaUxPaeoniae rubro, CUri Reticulatae d Gleditsiae spina in Danyu Xiaopi Granules. HPLC method was used for quantitative determination of the effective ingredients sodium dan-shensu in the monarch herb. Results The TLC spots of C on o ra i a p cn icu t , a a d ir eaPrunello Bulouris, Rupleupn chuieo and Gleditsiae spina were clear with gointerference. The linear ranges of sodium danshensu were 0.9-4. 5 （xg（ r = 0. 999 9）, the average recovery rate was 97.11%, was2. 34% （ n = 6）. Conclusion The method is simple, reliable and reproducible, which can be used for the quality control of mass productionof Danyu Xiaopi Granules.