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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40mg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,C_(max)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:C_(max)(3610±956),(3466±1209)ng.mL~(–1),t_(max)(3.00±0.40),(3.00±0.46)h,AUC0–t(8140±5065),(8390±5474)ng.h.mL~(–1),AUC_(0–∞)(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。
Objective To evaluate the pharmacokinetics and bioequivalence of two pantoprazole sodium enteric-coated tablets in healthy volunteers. Methods The two-period randomized crossover design of two preparations was adopted. HPLC-UV method was used to determine the oral dosage of pantoprazole sodium enteric-coated tablets (40mg) and pantoprazole sodium enteric-coated tablets in 20 male healthy subjects Lazole concentration of blood. Pharmacokinetic parameters were calculated using a non-compartmental model. After AUC and C_ (max) logarithmic transformation, ANOVA and 90% confidence intervals were calculated. Results The pharmacokinetic parameters of domestic and imported pantoprazole sodium enteric-coated tablets were as follows: C max 3610 ± 956, 3466 ± 1209 ng.mL -1, t max 3.00 ± 0.40), (3.00 ± 0.46) h, AUC0-t (8140 ± 5065), (8390 ± 5474) ng.h.mL -1, AUC 0- ∞ 8293 ± 5094, ± 5606) ng.h.mL ~ (-1). t1 / 2 (1.61 ± 0.28), (1.85 ± 0.27) h. Conclusion Domestic and imported pantoprazole sodium enteric-coated tablets have bioequivalence.