| 盐酸托烷司琼口腔崩解片在健康人体内的药动学及生物等效性 |
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| 引用本文： | 贾君,徐海燕,张凤娥,汤芳玲,潘澄,袁波.盐酸托烷司琼口腔崩解片在健康人体内的药动学及生物等效性[J].沈阳药科大学学报,2010,27(4):325-328. |
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| 作者姓名： | 贾君 徐海燕 张凤娥 汤芳玲 潘澄 袁波 |
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| 作者单位： | 沈阳药科大学 药学院，辽宁 沈阳 110016 |
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| 摘 要： | 目的建立测定人血浆中托烷司琼浓度的LC/MS/MS法,并用该法研究托烷司琼在健康人体内的药动学特征及其相对生物等效性。方法采用LC/MS/MS法,测定20名健康男性受试者口服含盐酸托烷司琼10 mg的受试制剂和参比制剂后,不同时刻血浆中托烷司琼的浓度,绘制药动学曲线并计算主要药动学参数。结果受试制剂和参比制剂中托烷司琼的主要药动学参数如下:tmax分别为(2.1±0.8)和(2.1±0.8)h;ρmax分别为(15.7±6.2)和(16.1±6.2)μg.L-1,t1/2分别为(9.9±5.0)和(9.4±5.0)h;用梯形法计算,AUC0-t分别为(213.2±162.7)和(210.1±159.2)μg.h.L-1,AUC0-∞分别为(231.0±190.4)和(231.2±190.9)μg.h.L-1。以AUC0-t计算,盐酸托烷司琼口腔崩解片中托烷司琼的相对生物利用度为(102.2±25.7)%。结论盐酸托烷司琼的两种制剂生物等效。
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| 关 键 词： | 盐酸托烷司琼 液质联用技术 药动学 生物等效性 |
| 收稿时间： | 2009-5-20 |
Pharmacokinetics and bioequivalence of tropisetron hydrochloride orally disintegrating tablets in healthy volunteers |
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| JIA Jun,XU Hai-yan,ZHANG Feng-e,TANG Fang-ling,PAN Cheng,YUAN Bo.Pharmacokinetics and bioequivalence of tropisetron hydrochloride orally disintegrating tablets in healthy volunteers[J].Journal of Shenyang Pharmaceutical University,2010,27(4):325-328. |
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| Authors: | JIA Jun XU Hai-yan ZHANG Feng-e TANG Fang-ling PAN Cheng YUAN Bo |
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| Institution: | School of Pharmacy, Shenyang Pharmaceutical University, Shenyang 110016, China |
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| Abstract: | Objective To develop a sensitive and rapid LC/MS/MS method to determine the plasma concentration of tropisetron and study the pharmacokinetics and bioequivalence of tropisetron hydrochloride tablets in healthy volunteers.Methods Twenty healthy volunteers were given a single oral dosage of 10 mg tropisetron hydrochloride test and reference formulation.The concentrations of tropisetron in plasma were determined by LC/MS/MS.The plasma concentration-time curves were plotted and the main pharmacokinetic paramete... |
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| Keywords: | tropisetron hydrochloride LC/MS/MS pharmacokinetics bioequivalence |
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