叶下珠配方颗粒、饮片汤剂药动学特性及生物等效性评价  

Evaluation for pharmacokinetic properties and bioequivalency of Yexiazhu Formula Granules and Decoction

作　　者：朱仙慕 黄群[1] 陈丹[1] 谢平[1] 马国萍[1] ZHU Xian-mu;HUANG Qun;CHEN Dan;XIE Ping;MA Guo-ping(College of Pharmacy,Fujian University of Traditional Chinese Medicine,Fuzhou 350122,China)

机构地区：[1]福建中医药大学药学院,福建福州350122

出　　处：《中成药》2024年第5期1451-1456,共6页Chinese Traditional Patent Medicine

基　　金：福建省科技计划项目(2010Y2004);福建省科技引导性项目(2019Y0037,2019Y0038)。

摘　　要：目的评价叶下珠配方颗粒、饮片汤剂药动学特性及生物等效性。方法12只大鼠随机分为2组,分别灌胃给予叶下珠配方颗粒、饮片汤剂溶液(0.4282、2.000 g/kg),于0.083、0.167、0.25、0.5、0.75、1、2、3、4、8、12、24、36 h采血,UPLC-MS/MS法测定没食子酸、柯里拉京、鞣花酸血药浓度,计算主要药动学参数。再考察这2种制剂的生物等效性。结果2种制剂AUC_(0~∞)、AUC_(0~t)、MRT_(0~∞)、MRT_(0~t)、t_(1/2)、T_(max)、CL、C_(max)比较,差异无统计学意义(P>0.05),其C_(max)、AUC_(0~∞)比值或对数均数的差值均在90%置信度下符合生物等效标准。结论叶下珠配方颗粒、饮片汤剂药动学特性接近,具有生物等效性。AIM To evaluate the pharmacokinetic properties and bioequivalency of Yexiazhu Formula Granules and Decoction.METHODS Twelve rats were randomly assigned into two groups and given intragastric administration of the solutions of Yexiazhu Formula Granules and Decoction(0.4282,2.000 g/kg),respectively,after which blood collection was made at 0.083,0.167,0.25,0.5,0.75,1,2,3,4,8,12,24,36 h,UPLC-MS/MS was adopted in the plasma concentration determination of gallic acid,corilagin and ellagic acid,and main pharmacokinetic parameters were calculated.Subsequently,the bioequivalency of these two preparations was investigated.RESULTS No significant differences in AUC_(0-∞),AUC_(0-t),MRT_(0-∞),MRT_(0-t),t_(1/2),T_(max),CL and C_(max)were observable between the two preparations(P>0.05),whose C_(max),AUC_(0-∞)ratios or logarithmic mean differences accorded with bioequivalence standard at the 90%confidence level.CONCLUSION Yexiazhu Formula Granules and Decoction demonstrate approximate pharmacokinetic properties and display bioequivalency.

关 键 词：叶下珠配方颗粒 叶下珠饮片汤剂 药动学特性 生物等效性 UPLC-MS/MS 

分 类 号：R969.1[医药卫生—药理学]