论文部分内容阅读
目的:研究泮托拉唑钠肠溶试验片与参比片的药代动力学与相对生物利用度。方法:20名男性健康志愿者单剂量口服泮托拉唑钠试验和参比制剂各40mg;采用反相高效液相色谱法测定其血药浓度。用DAS软件计算药代动力学参数,考察其生物等效性。结果:泮托拉唑钠肠溶片在人体的药动学行为符合二房室开放模型,试验片与参比片的主要药代动力学参数:Tmax分别为(3.18±0.54)和(3.30±0.47)h;Cmax分别为(2.98±0.83)和(2.91±0.87)mg·L-1;T12分别为(1.86±0.41)和(1.72±0.48)h;AUC0-t分别为(9.51±3.71)和(9.77±4.55)mg·h·L-1;相对生物利用度为(102.3±19.6)%。结论:泮托拉唑钠肠溶片两种制剂具有生物等效性。
Objective: To study the pharmacokinetics and relative bioavailability of pantoprazole sodium enteric-coated tablets and reference tablets. Methods: A total of 20 male volunteers were given a single oral dose of pantoprazole sodium (40 mg) and reference preparations (40 mg each) respectively. The plasma concentrations were determined by reversed-phase high performance liquid chromatography. Pharmacokinetic parameters were calculated using DAS software to investigate its bioequivalence. Results: The pharmacokinetic behavior of pantoprazole sodium enteric-coated tablets in human body was in accordance with the two-compartment open model. The main pharmacokinetic parameters of test and reference tablets were Tmax (3.18 ± 0.54) and (3.30 ± 0.47 ) h and Cmax were (2.98 ± 0.83) and (2.91 ± 0.87) mg · L-1, respectively. The T12 values were (1.86 ± 0.41) and (1.72 ± 0.48) (9.77 ± 4.55) mg · h · L -1, and the relative bioavailability was (102.3 ± 19.6)%. Conclusion: The two preparations of pantoprazole sodium enteric-coated tablets are bioequivalent.