不同类型六味地黄丸的物质组释放动力学特征及其可视化表征

Characteristics of materiome release kinetics and visual evaluation of different types of Liuwei Dihuang Pills

目的考察不同类型六味地黄丸的物质组释放动力学特征,并对其进行可视化表征。方法运用中药物质组释放动力学理论,参照《中国药典》2015年版,采用桨法装置测定不同类型六味地黄丸各时间点物质组释放率,拟合释放曲线,计算释放动力学特征参数;以市售最常见的水蜜丸、浓缩丸为参比制剂,对其他类型的六味地黄丸进行f2相似因子的计算评价;并采用物质组释放图谱、释放增量图谱,以期能够定量、整体并可视化评价不同类型六味地黄丸的物质组释放动力学特征。结果不同类型六味地黄丸的物质组释放动力学特征符合Weibull释放模型,计算各Weibull分布参数T50和Td,除浓缩丸与水泛丸外,各类型丸剂组间均有显著性差异(P<0.05),并运用f2相似因子法对比,发现不同类型六味地黄丸物质组释放具有一定的差异和相似性,通过物质组释放图谱与释放增量图谱可直观可视化地评价各类型丸剂的释放动力学特征。结论通过物质组释放动力学可以定量、整体并可视化地评价不同类型六味地黄丸的释放动力学特征,与古语所述"水丸取其易化,蜜丸取其缓化,糊丸取其迟化,蜡丸取其难化"基本相符。

Objective To investigate the characteristics of materiome release kinetics of Liuwei Dihuang Pills（LDP）,and to evaluate its visualization.Methods According to the 2015 edition of Chinese Pharmacopia,using the evaluation methods of release kinetics of Chinese material medica to determine the materiomics release kinetics and the releasecharacteristic of LDP by the paddle method.Then f2 fit factor was calculated and evaluated on other types of LDP in comparison with water-bindered pills and condensed pills as,which are two most common preparations in the market.Moreover,materiome release spectrum and release increment spectrum were used,hoping to quantify,integrate and visualise the materiome release characteristics of different types of LDP.Results The kinetic characteristics of the LDP accord with the Weibull release model,T（50） and Td were calculated,and there are significant differences between different types of pills（P 0.05） in addition to condensed pills and water pills.Also,some differences and similarities in the materiomics release characteristic by f2 fit factor were found in the study.Materiome release spectrum and release increment spectrum can be used to quantify,integrate and visualise the materiome release characteristics of LDP on different types.Conclusion The materiomics release kinetics can be applied to quantify,integrate and visualise the materiome release characteristic of LDP on different types.Basically in agreement with the saying,＂water pills from the facilitation,honey pills take the slow,paste pills from the late of,wax-wrapped pills take the difficult＂.