【作者】 李雅菁； 石森林； 吴素香； 郭菲； 熊阳；

【Author】 LI Ya-jing;SHI Sen-lin;WU Su-xiang;GUO Fei;XIONG Yang;Zhejiang Chinese Medical University;

【机构】 浙江中医药大学；

【摘要】 目的研究不同厂家小活络丸（大蜜丸）的物质组释放动力学特征及其与溶散时限的异同性。方法按2010版《中国药典》,以浆法75r·min^-1测定释放动力学特征,采用中药物质组释放度评价技术与方法,建立不同pH释放介质的多条溶出曲线:对小活络丸物质组释放度曲线进行释放动力学模型拟合;依法测定小活络丸的溶散时限。结果小活络丸（大蜜丸）具有显著的缓释特征:小活络丸释放参数T₅₀分别为甲厂:4.17h,乙厂:3.22h,丙厂:3.56h;T_d分别为甲厂:6.06h,乙厂:4.39h,丙厂:5.21h,三厂之间的T_d具有显著性差异（P<0.05）,T₅₀和T_d与溶散时限之间具有显著地正线性相关关系（r>0.9）。结论小活络丸（大蜜丸）释放动力学特征提示其具有明显的缓释特征,不同厂家丸剂的释放动力学特征具有显著差异,小活络丸溶散时限在一定程度上反映其物质组释放动力学特征。更多还原

【Abstract】 Objective:To study the materiomic release kinetics of Xiaohuoluo Pills(large Pill) produced by different manufacturers in different release mediums and their Correlation with time-limit of dissolution.Methods:Materiomics release kinetic profiles of Xiaohuoluo Pill were determined by the paddle method with a rotate speed at 75 r ? min"1 as in Chinese Pharmacopia,the materiome was quantified by UV-Vis combined Kalman filter method,and the time-limit of dissolution was determined as the method in Chinese Pharmacopia.Results:Xiaohuoluo Pills(large Pill) behaved typical sustained release profiles.T50 and Td,the release parameters of Xiaohuoluo Pills,were remarkably linearly correlation with time-limit of dissolution.Conclusion:The sustained release profile of Xiaohuoluo Pills demonstrates the obvious sustained release characteristic of the traditional pills,the materiomic release kinetics had significant difference both among the different manufacturers and the same batch of same manufacturer,the time-limit of dissolution reflects its materiomic release kinetics in some degree,too.更多还原