本文選題：恩替卡韋 + 生物利用度�。� 參考：《河北醫(yī)科大學(xué)學(xué)報(bào)》2016年12期

【摘要】：目的評(píng)價(jià)2種恩替卡韋制劑在健康人體的生物等效性。方法 20例男性健康志愿受試者隨機(jī)分成2組,分別交叉單劑量口服試驗(yàn)制劑(恩替卡韋分散片)或參比制劑(恩替卡韋片)0.5 mg,2周后交叉服藥,采用高效液相色譜-串聯(lián)質(zhì)譜法測(cè)定血漿中藥物濃度,以DAS 3.2.7軟件計(jì)算藥動(dòng)學(xué)參數(shù),進(jìn)行生物等效性評(píng)價(jià)。結(jié)果 2種制劑的峰濃度(Cmax)分別為(4.41±1.02)μg/L和(4.36±0.89)μg/L;達(dá)峰時(shí)間(tmax)為(0.66±0.19)h和(0.70±0.29)h;半衰期(t1/2)為(46.11±32.32)h和(61.28±93.69)h;曲線下面積(area under curve,AUC)0~72h為(13.31±2.63)μg·h~(-1)·L~(-1)和(13.10±2.20)μg·h~(-1)·L~(-1)。結(jié)論 2種恩替卡韋制劑生物等效,相對(duì)生物利用度為(103.3±14.0)%。
[Abstract]:Objective to evaluate the bioequivalence of two entecavir preparations in healthy volunteers. Methods Twenty male healthy volunteers were randomly divided into two groups. After 2 weeks, 20 healthy volunteers were randomly divided into two groups. After two weeks of cross-administration, one oral test preparation (entecavir dispersible tablet) or a reference preparation (entecavir tablet) were given orally. The drug concentration in plasma was determined by high performance liquid chromatography-tandem mass spectrometry. The pharmacokinetic parameters were calculated by DAS 3.2.7 software, and the bioequivalence was evaluated. 緇撴灉 2縐嶅埗鍓傜殑宄版祿搴，

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