本文選題：注射用多尼培南 + 健康人體藥代動(dòng)力學(xué)��； 參考：《四川大學(xué)學(xué)報(bào)(醫(yī)學(xué)版)》2015年01期

【摘要】：目的考察注射用多尼培南在中國(guó)健康人體單次給藥的臨床藥代動(dòng)力學(xué)特性,為臨床推薦優(yōu)化的治療方案。方法 12例健康志愿者按拉丁方三交叉試驗(yàn)設(shè)計(jì),隨機(jī)先后單劑量靜脈滴注多尼培南0.25、0.5、1.0g,采用高效液相色譜法分離紫外檢測(cè)法(HPLC-UV)測(cè)定人血漿及尿中多尼培南濃度。用Phoenix○R WinNonlin○R6.1藥代動(dòng)力學(xué)程序計(jì)算得到非房室模型統(tǒng)計(jì)矩參數(shù),并進(jìn)行藥代動(dòng)力學(xué)特征分析。結(jié)果單次靜脈滴注多尼培南0.25、0.5、1.0g后,血藥峰濃度(Cmax)分別為(11.81±1.52)、(22.80±3.80)和(47.26±8.38)μg/mL;達(dá)峰時(shí)間(Tmax)分別為(60.42±1.44)、(58.33±5.77)和(60.00±0)min;半衰期(t1/2)分別為(63.48±10.51)、(69.12±16.72)和(69.30±11.71)min;藥時(shí)曲線下面積(AUC0~t)分別為(1 100.86±150.04)、(2 111.50±359.58)和(4 359.50±789.38)μg/(mL·min)。直線回歸分析和置信區(qū)間法分析均提示本品具有線性藥代動(dòng)力學(xué)特征。本品主要經(jīng)腎臟排泄,給藥后24h尿液累積排泄率為70%~75%。本品安全性較好,不良反應(yīng)發(fā)生率為19.44%,均為輕度。結(jié)論注射用多尼培南具有線性動(dòng)力學(xué)特征,男女患者應(yīng)用本品無(wú)需調(diào)整給藥劑量。
[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. 緇撴灉鍗曟闈?rùn)鑴夋淮娉ㄥ灏煎煿鍗?.25,0.5,1.0g鍚，

本文編號(hào)：1919288