本文選題：瑞格列奈 + 二甲雙胍　； 參考：《中國醫(yī)院藥學雜志》2015年11期

【摘要】：目的:建立高效液相色譜-串聯(lián)質譜法(HPLC-MS/MS)同時測定人血漿中瑞格列奈和二甲雙胍濃度的方法,并進行人體藥動學研究。方法:以乙腈沉淀蛋白處理血漿樣品,替米沙坦做內標,采用Kromasil 60-5CN色譜柱(2.1 mm×100 mm,5μm),流動相為20 mmol·L-1醋酸銨水溶液(含0.2%甲酸)-乙腈(45∶55);質譜采用電噴霧離子化-多反應離子監(jiān)測(ESIMRM)。并測定12名健康志愿者單劑量口服瑞格列奈鹽酸二甲雙胍復方片(2 mg∶500 mg)后瑞格列奈和二甲雙胍的血漿濃度。結果:瑞格列奈和二甲雙胍分別在0.05~50μg·L-1、2~2 000μg·L-1范圍內線性良好,定量下限分別為0.05μg·L-1和2μg·L-1,日內日間精密度均小于8%,提取回收率分別為77.32%~80.65%和78.98%~82.46%。瑞格列奈和二甲雙胍的主要藥動學參數(shù)Cmax分別為(29.50±9.57),(1 167±197.77)μg·L-1;tmax分別為(0.83±0.39),(1.88±0.64)h;t1/2分別為(1.11±0.38),(4.31±0.86)h;AUC0→∞分別為(56.90±20.31),(7 407.32±1 653.25)μg·L-1·h-1。結論:建立的分析方法靈敏、準確可靠,樣品處理快速、簡便,適用于瑞格列奈/鹽酸二甲雙胍復方片人體藥動學和生物等效性研究。
[Abstract]:Objective: to establish a high performance liquid chromatography-tandem mass spectrometry (HPLC-MS / MS) method for simultaneous determination of reaglinide and metformin in human plasma and to study their pharmacokinetics. Methods: plasma samples were treated with acetonitrile precipitated protein and misartan was used as internal standard. The mobile phase was 20 mmol L-1 ammonium acetate aqueous solution (containing 0.2% formic acid-acetonitrile 45: 55) with Kromasil 60-5CN column of 2.1 mm 脳 100 mm ~ 5 渭 m ~ (-1). ESIMRM was monitored by electrospray ionization and multi-reaction ion. Plasma concentrations of repaglinide and metformin in 12 healthy volunteers were determined after oral administration of metformin hydrochloride compound tablets (2 mg:500 mg). Results: the linear range of reaglinide and metformin was 0.05 渭 g / L and 2 渭 g / L, respectively. The lower limit of quantification was 0.05 渭 g / L and 2 渭 g / L, respectively. The intra-day precision was less than 8 渭 g / L, and the recoveries were 77.32 ~ 80.65% and 78.98 ~ 82.46, respectively. The main pharmacokinetic parameters (Cmax) of repaglinide and metformin were 29.50 鹵9.57, 1.167 鹵197.77) 渭 g 路L ~ (-1) T _ (-1), respectively, were 0.83 鹵0.39 ~ (-1) h ~ (-1) t ~ (-1), 1.88 鹵0.64 h ~ (-1) h ~ (-1 / 2) were 1.11 鹵0.384.31 鹵0.86 h ~ (-1) AUC _ (0) 鈭，

本文編號：1805986