中文摘要 Omeprazole是一個質子幫浦抑制劑，作用在胃壁細胞，由之防止胃酸的分泌。臨床上用於治療 食道-胃反射疾病、胃潰瘍、 Zollinger-Ellison 綜合病徵。 本研究的目的是比較兩種 omeprazole產品 Biozole錠片劑和 Losec膠囊劑(劑量20 mg)在健康男性之生體可用率。經由測得之血中藥物濃度以 LAGRAM-P PROGRAM計算出相關之藥物動力學參數，以評估兩種產品是否為相等性。 本研究首先改良一個方便及精確的高效液相層析方法去定量血漿中omeprazole的濃度。利用 VERCOPACK INERTSIL 5 ODS 80A(4.6×150mm)管柱，移動相為acetonitrile-0.05M phosphate buffer(30:70 pH=7.5)，以 coumarin為內部標準品，流速為0.65ml/min，偵測波長為302nm。 二種 omeprazole產品( Biozole錠片劑與 Losec膠囊劑)之藥物動力學參數，包括最高血中濃度( Cmax)、到達最高血中濃度時間( Tmax)與曲線下面積( AUC)等無統計上的差異。; Abstract Omeprazole is a proton-pump inhibitor in gastric parietal cells and thus prevents secretion of gastric acid. It is used for the treatment of gastro-esophageal reflux disease, peptic ulcer and the Zollinger-Ellison syndrome. The aim of the present study was to evaluate the bioavailability of two different 20 mg omeprazole formulations( Biozole tablets and Losec capsules) by following administiation to 12 healthy subjects under fasting. Using LAGRAM-P PROGRAM to calculated pharmacokinetic parameters, the possible bioequivalency of these two products were determined. A convenient and precise high-performance liquid chromatographic method involving UV detection was described for determination of omeprazole in plasma. A VERCOPACK INERTSIL 5 ODS 80A (4.6X150 mm) column was used as the stationary phase and the mobile phase consisted of acetonitrile-0.05M phosphate buffer(30:70 pH=7.5) solution at a flow rate of 0.65 ml/min. The monitoring wavelength was set at UV 302 nm. The internal standard(coumarin) and omeprazole was eluted approximately at 14.03 min and 10.99 min, respectively. There are no significant statistic difference between pharmacokinetic parameters of two products(Biozole tablets and Losec capsules), including the peak concentrations (Cmax), time to peak (Tmax) and area under the curve( AUC).
