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
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摘要
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 f_2 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 T_d 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 f_2 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".
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 f_2 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 T_d 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 f_2 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".
引文
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[11]凌昳,张继稳,陈立兵,等.应用中药物质组释放动力学理论研究银翘解毒丸的缓释动力学及其同步性[J].药学学报,2008,43(11):1140-1146.
[12]楼云雁,石婷婷,陈立兵,等.运用UV-Vis考察五子衍宗丸物质组释放特征[J].中华中医药学刊,2011,29(7):1489-1491.
[13]吴佳佳,李智慧,石森林,等.桂枝茯苓丸的物质组释放动力学特征及可视化评价[J].浙江中医杂志,2014,49(4):299-302.
[14]郭桢,凌昳,张继稳,等.龙胆泻肝丸物质组释放动力学特征研究[J].中草药,2010,41(11):1806-1808.
[15]徐本亮,王冰,浦益琼,等.丹皮酚平衡溶解度与油水分配系数测定及大鼠在体肠吸收研究[J].中成药,2012,34(10):1892-1896.
[16]李文兰,扈正婷,季宇彬,等.马钱苷肠吸收机制的研究[J].中国中药杂志,2008,33(9):1052-1055.
[17]连赟芳,陈丹,蔡韦炜,等.基于特征图谱表征的玳玳黄酮滴丸组分群同步释药特性评价[J].中草药,2015,46(3):353-358.
[18]祝丽欣,陈芝,郭莹,等.f2相似因子法评价银杏酮酯缓释微丸大类成分总黄酮和各类成分的体外释放相关性研究[J].中草药,2015,46(23):3482-3488.
[19]张继稳,陈立兵,葛卫红,等.中药物质组相关概念释义[J].世界科学技术—中医药现代化,2008,10(2):1-4.
[20]张继稳,陈立兵,顾景凯,等.多组分中药化合物组释放同步性评价方法[J].药学学报,2008,43(6):647-651.
[21]王娟,狄留庆,单进军.中药传统丸剂的释药特点与机制分析[J].中成药,2012,34(4):723-726.
[2]刘霞,李亚.六味地黄丸联合利拉鲁肽和二甲双胍治疗2型糖尿病的临床研究[J].现代药物与临床,2016,31(8):1146-1150.
[3]谢奇.六味地黄丸在2型糖尿病治疗中的作用与研究[J].中医临床研究,2013,5(1):116-118.
[4]柴彦军.六味地黄丸联合消渴丸治疗气阴两虚2型糖尿病的临床研究[J].药物评价研究,2016,39(3):445-448.
[5]王久香.六味地黄丸联合氯沙坦钾治疗早期糖尿病肾病的临床研究[J].现代药物与临床,2015,30(6):674-677.
[6]杜标炎,郭玉荣,易华,等.六味地黄丸含药血清对自杀基因治疗黑色素瘤增效作用的缝隙连接机制初探[J].中国中西医结合杂志,2013,33(5):651-658.
[7]曹占花.阿卡波糖联合六味地黄丸治疗早期糖尿病肾病的临床疗效观察[J].现代药物与临床,2013,28(5):760-762.
[8]翁夏蒙,石森林,吴素香,等.不同厂家六味地黄丸溶散与释药特性的比较[J].中国实验方剂学杂志,2015,21(2):44-48.
[9]陈立兵,张继稳,顾景凯,等.中药制剂及给药系统的物质组释放/溶出动力学原理[J].中草药,2008,39(5):641-644.
[10]江叔奇,葛卫红,吴君金,等.冠心苏和丸的物质组释放动力学研究[J].中成药,2011,33(5):809-813.
[11]凌昳,张继稳,陈立兵,等.应用中药物质组释放动力学理论研究银翘解毒丸的缓释动力学及其同步性[J].药学学报,2008,43(11):1140-1146.
[12]楼云雁,石婷婷,陈立兵,等.运用UV-Vis考察五子衍宗丸物质组释放特征[J].中华中医药学刊,2011,29(7):1489-1491.
[13]吴佳佳,李智慧,石森林,等.桂枝茯苓丸的物质组释放动力学特征及可视化评价[J].浙江中医杂志,2014,49(4):299-302.
[14]郭桢,凌昳,张继稳,等.龙胆泻肝丸物质组释放动力学特征研究[J].中草药,2010,41(11):1806-1808.
[15]徐本亮,王冰,浦益琼,等.丹皮酚平衡溶解度与油水分配系数测定及大鼠在体肠吸收研究[J].中成药,2012,34(10):1892-1896.
[16]李文兰,扈正婷,季宇彬,等.马钱苷肠吸收机制的研究[J].中国中药杂志,2008,33(9):1052-1055.
[17]连赟芳,陈丹,蔡韦炜,等.基于特征图谱表征的玳玳黄酮滴丸组分群同步释药特性评价[J].中草药,2015,46(3):353-358.
[18]祝丽欣,陈芝,郭莹,等.f2相似因子法评价银杏酮酯缓释微丸大类成分总黄酮和各类成分的体外释放相关性研究[J].中草药,2015,46(23):3482-3488.
[19]张继稳,陈立兵,葛卫红,等.中药物质组相关概念释义[J].世界科学技术—中医药现代化,2008,10(2):1-4.
[20]张继稳,陈立兵,顾景凯,等.多组分中药化合物组释放同步性评价方法[J].药学学报,2008,43(6):647-651.
[21]王娟,狄留庆,单进军.中药传统丸剂的释药特点与机制分析[J].中成药,2012,34(4):723-726.