基于多指标成分同时检测的六味地黄浓缩丸溶出度测定  

Determination of dissolution of Liuwei Dihuang concentrated pills based on multi-index components

作　　者：罗云[1] 郝伟伟[1] 张婧[1] 梁新丽[1] 赵国巍[1] 杨明[1] 廖正根[1] 

机构地区：[1]江西中医药大学现代中药制剂教育部重点实验室,江西南昌330004

出　　处：《中国中药杂志》2014年第2期240-246,共7页China Journal of Chinese Materia Medica

基　　金：江西省卫生厅中医药科研计划项目(2012A033);江西省教育厅科研项目(GJJ13584);江西中医药大学重点学科青年教师培养计划项目(2012jzzdxk020)

摘　　要：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。With the content of gallic acid, loganin, paeoniflorin and paeonol as the indexes, to screen out dissolution determi- nation conditions, establish the dissolution determination method for multi-index components in Liuwei Dihuang concentrated pills, cal- culate and map the accumulative dissolution curve, and then compare the dissolution of products from different pharmaceutical factories through the similarity factor （f2）. According to the results, the optimum dissolution determination conditions were the paddle method, with 250 mL 0. 1 mol ~ L-t hydrochloric acid as the dissolution medium, and a rotation rate of 100 r ~ min-1. The similarity factor val- ues （f2） of the dissolution curves of the four main components of Liuwei Dihuang concentrated pills from different pharmaceutical facto- ties were mostly less than 50. This demonstrated a significant difference in the dissolution of Liuwei Dihuang concentrated pills from different pharmaceutical factories, and provided scientific basis for improving the equality evaluation of Liuwei Dihuang concentrated pills.

关 键 词：六味地黄浓缩丸 多成分 溶出度 相似因子 

分 类 号：R286[医药卫生—中药学]