复方白头翁汤结肠缓释片质量标准研究

Studies on the Quality Control of Compound Prescription Baitouweng Soup Colon Slow Release Tablets

目的:建立复方白头翁汤结肠缓释片的质量标准。方法:采用TLC对制剂中的白头翁、黄连和黄柏、秦皮进行定性鉴别;采用HPLC测定制剂中白头翁皂苷B4和盐酸小檗碱的含量。结果:白头翁、黄连和黄柏、秦皮薄层图谱斑点清晰,分离效果好,专属性强,限性对照无干扰;白头翁皂苷B4在0.60～6.00μg呈良好的线性关系,r=0.999 9,平均加样回收率100.08%,RSD 0.19%;盐酸小檗碱在0.135～1.350μg呈良好的线性关系(r=0.999 9),平均加样回收率为99.25%,RSD0.58%。结论:建立的定性、定量方法简单、重复性好,结果准确可靠,可作为复方白头翁汤结肠缓释片的质量控制方法。

Objective：To establish a quality control for compound prescription Baitouweng tang colon slow release tablets.Method：TLC method used in the preparation Pulsatilla Radix,Coptidis Rhizoma and Phellodendri Chinensis Cortex,Fraxini Corte qualitative identification;Determination by HPLC preparation Pulsatilla saponin B4 and berberine content.Result：Pulsatilla Radix,Coptidis Rhizoma,Phellodendri Chinensis Cortex,Fraxini Cortex layer of map spots were clear,separation effect,specific,limiting without interference,pulsatilla saponin B4 in 0.60-6.00 μg linear relationship,（r = 0.999 9）,the average recovery rate was 100.08%,RSD 0.19%.Berberine in 0.135-1.350 μg linear relationship（r=0.999 9）,the average recovery rate was 99.25%,RSD 0.58%.Conclusion：Establish the qualitative and quantitative method is simple,reproducible,accurate and reliable,and can be used as compound prescription Baitouweng tang colon slow release tablets quality control.