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目的:建立复方白头翁缓释微丸的质量控制方法。方法:采用TLC法鉴别方中白头翁、黄连、黄柏及秦皮;采用HPLC法测定微丸中白头翁皂苷B_4含量。结果:TLC法可检出白头翁、黄连、黄柏及秦皮的特征斑点,且斑点清晰;白头翁皂苷B_4含量在1.06～10.6μg范围内线性良好(r=0.999 7),平均回收率为99.65%(RSD=1.56%,n=9)。结论:本方法简便、准确,可用于该制剂的质量控制。
Objective: To establish a quality control method for compound Pulsatilla sustained-release pellets. Methods: TLC was used to identify Pulsatilla Chinensis, Coptis chinensis, Phellodendron chinense and Cortex Phellodendri. The content of Pulsatilla saponin B_4 in pellets was determined by HPLC. Results: The spots of Pulsatilla chinensis, Coptis chinensis, Phellodendron amurense and Cortex pendula were detected by TLC, and the spots were clear. The content of Pulsatilla saponin B_4 in the range of 1.06-10.6μg was linear (r = 0.999 7) and the average recovery was 99.65% (RSD = 1.56%, n = 9). Conclusion: This method is simple and accurate and can be used for the quality control of this preparation.