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目的建立同时快速测定六味地黄浓缩丸中没食子酸、马钱苷、芍药苷、丹皮酚成分的体外溶出测定方法,并考查其溶出特点。方法采用桨法,以250 m L 0.1 mol·L-1盐酸为溶出介质,转速100 r·min-1;用HPLC法测定六味地黄浓缩丸中4种成分的溶出度,并计算累积溶出度;采用相似因子法对溶出度曲线进行相似性比较。结果没食子酸与马钱苷、芍药苷、丹皮酚的相似因子分别为90.47、74.11、88.36,马钱苷与芍药苷、丹皮酚的相似因子分别为77.77、86.40,芍药苷与丹皮酚的相似因子为73.39。结论所用方法以0.1 mol·L-1盐酸为溶出介质时,六味地黄浓缩丸中的4个成分的溶出度具有同步性,可为其质量标准的制定提供参考。
OBJECTIVE To establish a rapid in vitro determination method for the dissolution of gallic acid, loganin, paeoniflorin and paeonol in Liuwei Dihuang Pills. Methods The paddle method was used. The dissolution rate was 100 r · min-1 with 250 mol L · mol·L -1 hydrochloric acid and the rotational speed was 100 r · min-1. The dissolution of four components in Liuweidihuang concentrated pills was determined by HPLC and the cumulative dissolution was calculated. Similarity method was used to compare the similarity of dissolution curves. Results Similarity factors of gallic acid with loganin, paeoniflorin and paeonol were 90.47, 74.11 and 88.36 respectively. The similarities of loganin with paeoniflorin and paeonol were 77.77 and 86.40, respectively. Paeoniflorin and paeonol The similarity factor is 73.39. Conclusions The dissolution rate of the four components in Liuwei Dihuang concentrated pills is in synchronicity with 0.1 mol·L-1 hydrochloric acid as dissolution medium, which can provide references for the formulation of quality standards.