银杏内酯B注射液在健康人体的药代动力学

目的研究中国健康志愿者单次静滴银杏内酯B(抗脑梗塞药)的药代动力学。方法26名健康志愿者随机分成3组,分别单次静滴银杏内酯B注射液20、40、60mg。用LC-MS-MS法测定给药后不同时间点血浆中的银杏内酯B浓度,并用DASver2.0软件计算其药代动力学参数。结果血药浓度-时间曲线符合二房室模型,药代动力学参数中,3组的t1/2z无显著性差异,并与给药剂量无关;3组的AUC0-t随给药剂量的加大而增加;3组的AUC/dose,c/dose间差异具有统计学意义。结论在20～60mg内,银杏内酯B注射液的体内过程,基本符合线性动力学特征。

Pharmacokinetics of ginkalide B injection after a single dose in Chinese healthy volunteers

Objective To study the pharmacokinetics of a single dose ginkalide B in Chinese healthy volunteers.Methods Twenty six healthy volunteers were divided into 3 groups randomly,the concentrations of plasma samples collected from the volunteers iv 20,40,60 mg ginkalide B injection respectively were determined by LC/MS/MS.The pharmacokinetic parameters were calculated by DAS ver 2.0 software.Results The plasma concentration-time curve fits two compartment model after iv ginkalide B injection 20,40,60 mg.There were no significant difference in pharmacokinetic parameter t1/2z among the three groups.But AUC0-t creased with dose rising.There were significant difference in AUC/dose and C/dose each other three groups.Conclusion The results show that the process of the drug in the dosage range from 20 mg to 60 mg in human body fit liner dynamic.