甲苯璜酸妥舒沙星分散片在人体内的相对生物利用度  

Relative Bioavailability of Tosufloxacin Tosylate Dispersible Tablet in Healthy Volunteers

作　　者：喻德雅[1] 蔡亚敏[1] 谭鸿毅[2] 裴奇[2] 黄志军[2] 刘畅[2] 阳国平[2] 

机构地区：[1]解放军163医院,湖南长沙410003 [2]中南大学湘雅三医院临床药理中心,湖南长沙410013

出　　处：《医学临床研究》2007年第9期1543-1545,共3页Journal of Clinical Research

摘　　要：【目的】研究甲苯璜酸妥舒沙星分散片的相对生物利用度。【方法】采用随机、开放、双周期交叉试验设计。18名健康志愿者分别单剂量口服300mg甲苯璜酸妥舒沙星片(参比制剂)或甲苯璜酸妥舒沙星分散片(受试制剂)。采用HPLC法测定给药后不同时间的妥舒沙星血药浓度。【结果】参比制剂和受试制剂中的妥舒沙星Cmax分别为(927±200)μg/L、(926±210)μg/L;tmax分别为(1.17±0.24)h、(1.22±0.26)h;t1/2分别为(4.6±0.5)h、(4.4±0.5)h;AUC0～24h分别为(4978±1284)μg/(h.L)、(5005±1349)μg/(h.L)。受试制剂的相对生物利用度为(100.8±11.3)%。【结论】受试制剂与参比制剂具有生物等效性。To study the pharmacokinetics and relative bioavailability of tosufloxacin tosylate dispersible tablet in healthy volunteers. [Methods]A single oral dose of 300 mg of tosufloxacin tosylate dispersible tablets and common tablets were administrated according to randomized two-way cross-over design. Tosufloxacin concentrations in plasma were determined by HPLC in the different times. [Results]The pharmacokinetic parameters of reference formulation and test formulation were as follows： Cmax were （927 ± 200）mg/L and（926 ± 210）mg/L; were （1.17 ± 0.24）h and（1.22 ± O. 26）h; t1/2 were（4.6±0.5）h and（4.4±0.5） h; AUC0-4h were（4978± 1284）mg/（h· L） and（5005 ± 1349）mg/（h ~ L）. The relative bioavailability of the test formulation was （100.8 ± 11.3）. [Conclusion]The two formulations are bioequivalent.

关 键 词：癌 非小细胞肺/药物疗法 顺铂/投药和剂量 紫杉酚/投药和剂量 

分 类 号：R730.26[医药卫生—肿瘤]