右旋佐匹克隆在中国健康受试者中的药代动力学研究
发布时间:2018-04-08 19:29
本文选题:右旋佐匹克隆 切入点:药代动力学 出处:《中国临床药理学杂志》2015年24期
【摘要】:目的评价中国健康受试者单次服用不同剂量以及连续多次服用右旋佐匹克隆的药代动力学特征。方法单次给药组12名受试者随机、交叉、空腹口服右旋佐匹克隆1.5,3.0,6.0 mg;多次给药组8名受试者每天空腹口服右旋佐匹克隆3.0 mg,连续7 d。用HPLC-MS/MS法测定不同时间点血浆右旋佐匹克隆的浓度,用3P97程序计算药代动力学参数并对给药剂量与C_(max)和AUC进行线性相关性分析。结果单次口服右旋佐匹克隆1.5,3.0,6.0 mg的药代动力学参数如下:C_(max)分别为(18.08±4.65),(38.29±15.41),(76.38±23.34)ng·mL~(-1);t_(max)分别为(0.94±0.39),(1.04±0.63),(1.08±0.51)h;AUC_(0-t)分别为(110.90±23.06),(227.36±62.41),(504.10±140.13)ng·mL~(-1)·h;t_(1/2)分别为(5.84±1.03),(5.53±1.91),(6.17±1.23)h。多次给药的药代动力学参数如下:C_(max)为(33.43±5.63)ng·mL~(-1),t_(max)为(1.38±0.50)h,AUC_(ss)为(263.30±51.21)ng·mL~(-1)·h,t_(1/2)为(6.74±1.49)h。主要不良事件包括口苦或味觉异常等,停药后均自行缓解或消失。结论右旋佐匹克隆在1.5~6.0 mg内呈剂量比例关系的线性药代动力学特征,该药用于人体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.缁撴灉鍗曟鍙f湇鍙虫棆浣愬尮鍏嬮殕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,
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