恩替卡韦分散片人体药动学及生物等效性研究

发布时间：2018-06-25 18:04

  本文选题：恩替卡韦 + 生物利用度　； 参考：《河北医科大学学报》2016年12期

【摘要】：目的评价2种恩替卡韦制剂在健康人体的生物等效性。方法 20例男性健康志愿受试者随机分成2组,分别交叉单剂量口服试验制剂(恩替卡韦分散片)或参比制剂(恩替卡韦片)0.5 mg,2周后交叉服药,采用高效液相色谱-串联质谱法测定血浆中药物浓度,以DAS 3.2.7软件计算药动学参数,进行生物等效性评价。结果 2种制剂的峰浓度(Cmax)分别为(4.41±1.02)μg/L和(4.36±0.89)μg/L;达峰时间(tmax)为(0.66±0.19)h和(0.70±0.29)h;半衰期(t1/2)为(46.11±32.32)h和(61.28±93.69)h;曲线下面积(area under curve,AUC)0~72h为(13.31±2.63)μg·h~(-1)·L~(-1)和(13.10±2.20)μg·h~(-1)·L~(-1)。结论 2种恩替卡韦制剂生物等效,相对生物利用度为(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. 缁撴灉 2绉嶅埗鍓傜殑宄版祿搴，

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