泮托拉唑钠肠溶片在健康中国人体内的药动学研究及生物等效性评价

摘要

Aim To evaluate the pharmacokinetics and bioequivalence of domestic pantoprazole sodium enteric-coated tablets as compared with imported pantoprazole enteric-coated tablets. Methods This was an open randomized, two periods cross over study on twenty healthy male volunteers. The pantoprazole concentrations in plasma after an oral dose of 40 mg pantoprzaole preparations were determined by a HPLC-UV method. Non-compartmental method was used for the calculation of pharmacokinetic parameters. Logarithm-transformed Cmax and AUC were analyzed by the analysis of variance (ANOVA) with 90% confidence intervals. Results The main pharmacokinetics parameters of domestic pantoprazole sodium enteric-coated tablets and (1.61±0.28), (1.85±0.27) h, respectively. Conclusion Domestic pantoprazole sodium enteric-coated tablets were bioequivalent with the imported pantoprazole sodium enteric-coated tablets.%目的 评价健康受试者单剂量口服两种泮托拉唑钠肠溶片的人体药动学与生物等效性.方法 采用两种制剂两周期随机交叉试验设计,HPLC-UV法测定20名男性健康受试者单剂量口服40 mg国产泮托拉唑钠肠溶片和进口泮托拉唑钠肠溶片后泮托拉唑的血药浓度.采用非室模型计算药动学参数.AUC,Cmax对数转换后进行方差分析并计算90%可信区间.结果 国产和进口泮托拉唑钠肠溶片的药动学参数分别为:Cmax(3610±956),(3466±1209)ng·mL-1,tmax(3.00±0.40),(3.00±0.46)h,AUC0-t(8140±5065),(8390±5474)ng·h·mL-1,AUC0-∞(8293±5094),(8625±5606)ng·h·mL-1.t1/2(1.61±0.28),(1.85±0.27)h.结论 国产和进口泮托拉唑钠肠溶片具有生物等效性.