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建立了RP-HPLC快速测定血浆中奥美拉唑的方法,应用该法测定了10名健康志愿受试者随机交叉单剂量口服奥美拉唑受试片和进口胶囊后的血药浓度,结果表明:两种制剂在人体内的药动学行为均符合一级吸收的开放一室模型,其达峰时间(tmax)分别为(2.60±0.94)h和(3.30±.82)h;峰浓度(Cmax)分别为(1171.0±553.2)ng/ml和(1214.9±590.2)ng/ml;生物半衰期(t1/2)分别为(0.95±0.44)h和(1.06±0.73)h;血浓经时曲线下面积(AUC)分别为(3691.8±2665.2)ng·h/ml和(3387.2±2408.7)ng·h/ml,配对t检验结果表明,差异均无显著性(P>0.05)。经双单侧t检验,结果显示两者在生物利用度方面属于等效,相对生物利用度为108.23%。
A rapid method for the determination of omeprazole in plasma by RP-HPLC was established. The concentration of plasma omeprazole and oral capsules after oral administration of omeprazole in 10 healthy volunteers were determined. The results showed that the pharmacokinetic behaviors of the two preparations accord with the first-order absorption in the open one-compartment model, and the peak time (tmax) were (2.60 ± 0.94) h and (3.30 ±), respectively. 82) h. The peak concentrations (Cmax) were (1171.0 ± 553.2) ng / ml and (1214.9 ± 590.2) ng / ml, ± 0.44) h and (1.06 ± 0.73) h respectively; the area under the curve of blood concentration over time (AUC) were (3691.8 ± 2665.2) ng · h / ml and (3387.2 ± 2408.7) ng · h / ml. The paired t test showed no significant difference (P> 0.05). The results of two-sided t-test showed that both of them were equivalent in bioavailability and the relative bioavailability was 108.23%.