摘要
目的:研究国产与进口硫酸氢氯吡格雷片在健康人体内的药动学特征及生物等效性。方法:采用标准两周期交叉设计自身对照试验方法,20名健康志愿者单剂量口服硫酸氢氯吡格雷片受试制剂(国产)或参比制剂(进口)75mg后,用液-质联用(LC-MS)法测定人血浆中氯吡格雷的浓度,计算其药动学参数并评价2种制剂的生物等效性。结果:受试制剂与参比制剂的各主要药动学参数分别为:tmax(0.64±0.21)、(0.68±0.27)h,cmax(1.724±1.38)、(1.752±1.856)ng·mL-1,t1/2(6.6±4.9)、(6.3±7.0)h,AUC0～36h(1.996±1.223)、(2.112±1.493)ng·h·mL-1,AUC0～∞(2.114±1.209)、(2.117±1.500)ng·h·mL-1。受试制剂相对于参比制剂的生物利用度为(108.9±52.2)%。结论:2种硫酸氢氯吡格雷片具有生物等效性。
OBJECTIVE： To study the pharmacokinetic characteristics and bioequivalence of domestic and imported Clopidogrel hydrogen sulfate tablets. METHODS： In randomized crossover designed self-controlled study, 20 healthy volunteers were given single oral dose of Clopidogrel hydrogen sulfate tablets of trial preparation 75 mg （domestic product） or reference preparation 75 mg （imported product）. The plasma concentrations of clopidogrel were determined by LC-MS. The pharmacokinetic parameters wes calculated and bioequivalence was evaluated. RESULTS： Main pharmacokinetic parameters of trial preparation and reference preparation were as follows： tmax（0.64 ± 0.21） h and （0.68 ± 0.27）h; Cmax（1.724 ± 1.38）ng.mL 1 and （1.752 ± 1.856）ng.mL^-1; tl/2（6.6 ± 4.9）h and （6.3 ± 7.0） h; AUC0-36 h（1.996 ± 1.223）ng-h.mL^-1 and （2.112 ± 1.493）ng.h.mL^-1; AUC0-∝（2.114 ± 1.209）ng.h.mL-1 and （2.117 ± 1.500） ng. h. m^-1. The relative bioavailability of trial preparation was （108.9 ± 52.2）%. CONCLUSION： The two kinds of Clopidogrel formulations are bioequivalent.
出处
《中国药房》
CAS
CSCD
北大核心
2011年第34期3201-3203,共3页
China Pharmacy
