中国中药杂志

2014, v.39(02) 240-246

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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

罗云;郝伟伟;张婧;梁新丽;赵国巍;杨明;廖正根;
LUO Yun;HAO Wei-wei;ZHANG Jing;LIANG Xin-li;ZHAO Guo-wei;YANG Ming;LIAO Zheng-gen;Key Laboratory of Modern Preparation of Traditional Chinese Medicine under Ministry of Education, Jiangxi University of Traditional Chinese Medicine;

摘要(Abstract):

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 determination conditions,establish the dissolution determination method for multi-index components in Liuwei Dihuang concentrated pills,calculate and map the accumulative dissolution curve,and then compare the dissolution of products from different pharmaceutical factories through the similarity factor( f 2). According to the results,the optimum dissolution determination conditions were the paddle method, with 250 mL 0. 1 mol·L- 1hydrochloric acid as the dissolution medium,and a rotation rate of 100 r·min- 1. The similarity factor values( f 2) of the dissolution curves of the four main components of Liuwei Dihuang concentrated pills from different pharmaceutical factories 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(KeyWords): 六味地黄浓缩丸;多成分;溶出度;相似因子
Liuwei Dihuang concentrated pills;multi-component;dissolution;similarity factor

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基金项目(Foundation): 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)

作者(Author): 罗云;郝伟伟;张婧;梁新丽;赵国巍;杨明;廖正根;
LUO Yun;HAO Wei-wei;ZHANG Jing;LIANG Xin-li;ZHAO Guo-wei;YANG Ming;LIAO Zheng-gen;Key Laboratory of Modern Preparation of Traditional Chinese Medicine under Ministry of Education, Jiangxi University of Traditional Chinese Medicine;

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