泮托拉唑钠肠溶胶囊在健康人体的药动学和生物等效性

 目的评价2种泮托拉唑钠肠溶胶囊(抗溃疡药)的生物等效性。方法20名男性健康志愿者随机交叉单剂量分别口服泮托拉唑钠试验和参比制剂40mg;用HPLC内标法测定其血药浓度,用DAS软件计算药动学参数,考察其生物等效性。结果2制剂在健康人体的药-时曲线符合二房室开放模型,主要药动学参数:t_1/2分别为(1.875±0.636),(1.860±0.785)h;t_max(3.083±0.393),(3.028±0.436)h;ρ_max(2.969±0.616),(2.961±0.493)mg·L^-1;AUC_0-t(8.478±4.493),(8.460±4.293)mg·h·L^-1;相对生物利用度为(100.0±9.0)%。结论2种制剂具有生物等效性。

Pharmacokinetics and Bioequivalence of Pantoprazole Sodium Enteric-Coated Capsules in Healthy Volunteers

OBJECTIVE To evaluate bioequivalence of pantoprazole sodium enteric-coated capsules in healthy volunteers.METHODS A single oral dose of 40 mg pantoprazole sodium enteric-coated test and reference capsules was given to 20 male healthy volunteers in a randomized crossover design.The plasma concentrations were determined by HPLC.Pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two preparations.RESULTS Plasma concentration-time profiles were adequately described by a two-compartment open model.The main pharmacokinetic parameters of pantoprazole sodium test and reference capsules were as follow:t_1/2(1.875±0.636) and(1.860±0.785)h,t_max(3.083±0.393) and(3.028±0.436)h;ρ_max(2.969±0.616) and(2.961±0.493)mg·L^-1;AUC_0-t(8.478 ±4.493) and(8.460±4.293) mg·h·L^-1,respectively.The relative bioavailability of test capsules was(100.0±9.0)%.CONCLUSION The two preparations of pantoprazole sodium are bioequivalent.