注射用多尼培南健康人体药代动力学研究

发布时间：2018-05-21 12:56

  本文选题：注射用多尼培南 + 健康人体药代动力学　； 参考：《四川大学学报(医学版)》2015年01期

【摘要】：目的考察注射用多尼培南在中国健康人体单次给药的临床药代动力学特性,为临床推荐优化的治疗方案。方法 12例健康志愿者按拉丁方三交叉试验设计,随机先后单剂量静脉滴注多尼培南0.25、0.5、1.0g,采用高效液相色谱法分离紫外检测法(HPLC-UV)测定人血浆及尿中多尼培南浓度。用Phoenix○R WinNonlin○R6.1药代动力学程序计算得到非房室模型统计矩参数,并进行药代动力学特征分析。结果单次静脉滴注多尼培南0.25、0.5、1.0g后,血药峰浓度(Cmax)分别为(11.81±1.52)、(22.80±3.80)和(47.26±8.38)μg/mL;达峰时间(Tmax)分别为(60.42±1.44)、(58.33±5.77)和(60.00±0)min;半衰期(t1/2)分别为(63.48±10.51)、(69.12±16.72)和(69.30±11.71)min;药时曲线下面积(AUC0~t)分别为(1 100.86±150.04)、(2 111.50±359.58)和(4 359.50±789.38)μg/(mL·min)。直线回归分析和置信区间法分析均提示本品具有线性药代动力学特征。本品主要经肾脏排泄,给药后24h尿液累积排泄率为70%~75%。本品安全性较好,不良反应发生率为19.44%,均为轻度。结论注射用多尼培南具有线性动力学特征,男女患者应用本品无需调整给药剂量。
[Abstract]:Objective to investigate the pharmacokinetic characteristics of single dose of Donipenem for injection in Chinese healthy volunteers. Methods 12 healthy volunteers were randomly assigned to single dose intravenous drip of Donipenem 0.25 and 0.5 渭 g. The concentration of Donipenem in human plasma and urine was determined by high performance liquid chromatography (HPLC) separation and ultraviolet detection (HPLC-UV). The concentration of Donipenem in human plasma and urine was determined by high performance liquid chromatography (HPLC). The statistical moment parameters of non-atrioventricular model were calculated by Phoenix0R WinNonlin0R6.1 pharmacokinetic program, and the pharmacokinetic characteristics were analyzed. 缁撴灉鍗曟�￠潤鑴夋淮娉ㄥ�氬凹鍩瑰崡0.25,0.5,1.0g鍚，

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