复方丹参片中5种活性成分的溶出度比较

Comparative study of dissolution on five active components of Fufang Danshen tablets

目的研究复方丹参片中5种活性成分的体外溶出特点。方法采用HPLC法测定复方丹参片中5种活性成分在不同溶出介质中的体外溶出度,计算活性成分的累积溶出百分率,采用相似因子(f2)进行释放曲线的相似性比较。结果在0.5%十二烷基硫酸钠水溶液中,原儿茶醛、三七皂苷R1、丹酚酸B、丹参酮ⅡA与丹参素的相似因子分别为60、61、73、17;在0.1 mo.lL-1的HCl溶液中,原儿茶醛、三七皂苷R1、丹酚酸B与丹参素的相似因子分别为70、40、36。结论在0.5%十二烷基硫酸钠水溶液与0.1 mol.L-1HCl溶液中,复方丹参片的活性成分不具有同步溶出的特点。

OBJECTIVE To study the dissolution characteristics of five active components of Fufang Danshen tablets in vitro. METHODS The different dissolution solvents and the dissolution rates in vitro of five kinds of active components of Fufang Danshen tablets were investigated. The contents of active components were determined by HPLC. The accumulative dissolution percentages were calculated, and the resemblance of release curves were compared by similarity factors （f2）. RESULTS Compared with danshensu, the similarity factors of protocatechualdehyde , notoginsenoside R1, salvianolic acid B, tanshinone ⅡA were 60,61,73 and 17 in 0.5% SDS solution, respectively. The similarity factors of protocatechualdehyde, notoginsenoside R1, salvianolic acid B were 70,40 and 36 in 0.1 mol·L^-1 HCl solution, respectively. CONCLUSION The dissolution of active components of Fufang Danshen tablets do not have the same characteristics of synchronous dissolution in 0. 5% SDS solution and in 0.1 mol·L^-1 HCl solution.