不同厂家六味地黄丸溶散与释药特性的比较

目的:评价六味地黄丸物质组释放动力学特性、溶散特征及其相关性。方法:选择甲乙丙3个厂家的六味地黄丸,其中甲厂家采集了3个批号的样本,采用中药物质组释放度评价技术与方法,参照2010年版《中国药典》,以桨法测定各时间点释放度,拟合释放曲线,计算释放动力学特征参数;检测各厂家批号六味地黄丸的溶散时间;分析六味地黄丸释药特征参数与其溶散时间的相关性。结果:六味地黄丸具有一定的缓释特征,动力学特征符合Weibull释放模型,计算各Weibull分布参数T50和Td。甲、乙、丙三厂家丸剂的T50分别为107.01,134.33,13.01 min,Td分别为234.11,292.33,37.66 min,均有显著性差异(P0.01);厂家甲3个批号丸剂的T50分别为107.01,125.93,194.44 min,Td分别为234.11,385.42,206.17 min,批次间也有显著差异(P0.01);厂家甲(3个批号)、乙、丙六味地黄丸的溶散时间依次为32,43,37,35,21 min,符合《中国药典》要求,但存在一定差异;六味地黄丸的释药速率参数T50,Td与其溶散时间之间均具有显著的正线性相关关系(P0.05)。结论:六味地黄丸的物质组释放动力学特征存在显著的厂间、批间差异,其释药速率与溶散时间具有相关性。

Comparative of Dissolution and Drug Releasing Characteristics of Liuwei Dihuang Pills Produced by Different Manufacturers

Objective: To study materiomic of release kinetics and dissolution characteristics of Liuwei Dihuang pills and correlation of them. Method: Choosing Liuwei Dihuang pills from three manufacturers and different batches produced by manufacturer A. According to Chinese Pharmacopia, using the evaluation methods of release kinetics of traditional Chinese Medicine to determining the materiomics release kinetics and the release characteristic of Liuwei Dihuang pills by the paddle method, determining the dissolution time, and analyzing the correlation between the characteristic parameter of drug release and dissolution of Liuwei Dihuang pills. Result: T₅₀ of Liuwei Dihuang pills of the three manufacturers are 107.01,134.33,and 13.01 min, respectively while T_d are 234.11,385.42,and 206.17 min. The materiomic release kinetics had significant difference among three different manufacturers (P<0.01);T₅₀ of Liuwei Dihuang pills of three different batches produced by manufacturer A are 107.01, 125.93, 194.44 min and T_d of them are 234.11, 385.42, 206.17 min. The materiomic release kinetics had significant difference among different batches produced by manufacturer A (P<0.01). Their disintegration time are 32, 43, 37, 35, 21 min, there was high lever of linear correlation between the release curve fitting parameter as T50, T_d and disintegration time trials result (P<0.05). Conclusion: There were significant difference among Liuwei Dihuang pills of different manufacturers or different batches produced by manufacturer A under the evaluation methods of materiomic release kinetics. And the release rate has correlation with the disintegration time.