本文選題：右旋佐匹克隆　切入點(diǎn)：藥代動(dòng)力學(xué)　出處：《中國臨床藥理學(xué)雜志》2015年24期

【摘要】：目的評價(jià)中國健康受試者單次服用不同劑量以及連續(xù)多次服用右旋佐匹克隆的藥代動(dòng)力學(xué)特征。方法單次給藥組12名受試者隨機(jī)、交叉、空腹口服右旋佐匹克隆1.5,3.0,6.0 mg;多次給藥組8名受試者每天空腹口服右旋佐匹克隆3.0 mg,連續(xù)7 d。用HPLC-MS/MS法測定不同時(shí)間點(diǎn)血漿右旋佐匹克隆的濃度,用3P97程序計(jì)算藥代動(dòng)力學(xué)參數(shù)并對給藥劑量與C_(max)和AUC進(jìn)行線性相關(guān)性分析。結(jié)果單次口服右旋佐匹克隆1.5,3.0,6.0 mg的藥代動(dòng)力學(xué)參數(shù)如下:C_(max)分別為(18.08±4.65),(38.29±15.41),(76.38±23.34)ng·mL~(-1);t_(max)分別為(0.94±0.39),(1.04±0.63),(1.08±0.51)h;AUC_(0-t)分別為(110.90±23.06),(227.36±62.41),(504.10±140.13)ng·mL~(-1)·h;t_(1/2)分別為(5.84±1.03),(5.53±1.91),(6.17±1.23)h。多次給藥的藥代動(dòng)力學(xué)參數(shù)如下:C_(max)為(33.43±5.63)ng·mL~(-1),t_(max)為(1.38±0.50)h,AUC_(ss)為(263.30±51.21)ng·mL~(-1)·h,t_(1/2)為(6.74±1.49)h。主要不良事件包括口苦或味覺異常等,停藥后均自行緩解或消失。結(jié)論右旋佐匹克隆在1.5~6.0 mg內(nèi)呈劑量比例關(guān)系的線性藥代動(dòng)力學(xué)特征,該藥用于人體的安全性及耐受性良好。
[Abstract]:Objective to evaluate the pharmacokinetic characteristics of single dose and multiple doses of dexzopicron in Chinese healthy volunteers.Methods Twelve subjects in the single administration group were randomly divided into two groups: the control group (n = 12) and the control group (n = 8) took dextrozopicron 3.0 mg per day for 7 days.The plasma concentration of dextrozopicron at different time points was determined by HPLC-MS/MS method. The pharmacokinetic parameters were calculated by 3P97 program, and the linear correlation between dosage and Che max) and AUC were analyzed.緇撴灉鍗曟鍙ｆ湇鍙蟲棆浣愬尮鍏嬮殕1.5,3.0,6.0 mg鐨勮嵂浠ｅ姩鍔涘鍙傛暟濡備笅:C_(max)鍒嗗埆涓，

本文編號(hào)：1723052