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以没食子酸、马钱苷、芍药苷、丹皮酚的含量为指标,筛选溶出度测定条件,建立六味地黄浓缩丸多指标成分的溶出度测定方法,计算并绘制累积溶出曲线,再通过相似因子(f2)比较不同厂家产品的溶出度差异。结果显示,最佳的溶出度测定条件为采用桨法,以250 mL 0.1 mol·L-1盐酸为溶出介质,转速100 r·min-1。不同厂家六味地黄浓缩丸中4种成分的溶出曲线相似因子f2大多小于50,表明不同厂家六味地黄浓缩丸溶出度存在显著性差异,为完善六味地黄浓缩丸的质量评价提供科学依据。
The content of gallic acid, loganin, paeoniflorin and paeonol were used as indexes to determine the dissolution conditions of the Liuwei Rehmannia glutinosa pellets. The dissolution index of the multi-index components of Liuweidihuang concentrated pills was established. The cumulative dissolution curve was calculated and plotted. (f2) Compare the dissolution of different manufacturers of products. The results showed that the optimum conditions of dissolution were paddle method, 250 mL 0.1 mol·L-1 hydrochloric acid as dissolution medium and 100 r · min-1 rotation speed. The flotation curve similarity factor f2 of four components of Liuwei Rehmanniae Pills from different manufacturers is mostly less than 50, indicating that there are significant differences in dissolution rate of Liuwei Rehmanniae Pills from different manufacturers, providing a scientific basis for improving the quality evaluation of Liuweidihuang Pills.