六味地黄浓缩丸中4种活性成分的溶出度比较

Comparative of dissolution on four active components of Liuwei Dihuang concentrated pills

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 an HPLC method for the simuhaneous determination of gallic acid, loganin, paeoniflorin and paeonol of Liuwei Dihuang concentrated pills （ LDCP ）, and study the dissolution characteristics of four active components in vitro. METHODS The paddle method was used with 250 mL 0. 1 mol·L^-1 hydrochloric acid as the dissolution medium, and the rotate speed was 100 r·min^-1. The dissolution of 4 active components of LDCP were determined by HPLC. The accumulative dissolution percentages were calculated and the resemblance of release curves were compared by similarity factors. RESULTS Compared with gallic acid, the similarity factors of loganin, paeoniflorin and paeonol were 90.47,74. 11 and 88. 36. Compared with loganin, the similarity factors of paeoniflorin and paeonol were 77.77 and 86.40. Compared with paeoniflorin, the similarity factors of paeonol was 73.39. CONCLUSION The dissolution of gallic acid, loganin, paeoniflorin and paeonol of LDCP have the same characteristics of synchronous dissolution in 0.1 mol·L^-1 hydroehloric acid. It can be for the quality control of LDCP.