RP-HPLC测定血浆中奥美拉唑及其相对生物利用度研究

Rapid RP HPLC Determination of Omeprazole in Human Plasma for Relative Bioavailabilitly

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 sensitive,rapid RP HPLC method was developed for the dedermination of omeprazole in human plasma and the pharmacokinetics and bioavailability of omeprazole were investigated The one-compartment open model with first order absorption was used to describe the time course of plasma concentrations of omeprazole in ten volunteers following the administration of a single oral dose of 40mg test tablet or reference capsule The results were as follow:t max =(2 60±0 94)h and (3 30±0 82)h,C max =(1171 0±553 2)ng/ml and (1214 9±590 2)ng/ml,t 1/2 =(0 95±0 44)h and (1 06±0 73)h,and AUC=(3691 8±2665 2)ng/h·ml -1 and (3387 2±2408 7)ng/h·ml -1 for the test tablet and the reference capsule respectively It is shown,through the double onesidt tests,that the test tablet and reference capsule were bioequvalent with the relative bioavailability of 108 23%