中国临床药理学与治疗学2013，Vol.18Issue(5)：545-549,5.
布洛芬缓释胶囊在健康人体的相对生物利用度研究
Study of the relative bioequivalence of sustained release capsules of Ibuprofen in healthy volunteers
摘要
Abstract
AIM:To study the relative bioequivalence of sustained release capsules of Ibuprofen made by Jiangxi Pharmaceutical Co.,Ltd.METHODS:A single dose of 300 mg domestic Ibuprofen,and its reference preparation made by Zhengzhou Fusheng Pharmaceuticals Co.,Ltd.were given to 24 healthy volunteers by oral in an open randomized two way crossover experiment.The plasma concentrations were determined by HPLC method.RESULTS:The main pharmacokinetic parameters of a single dose of Ibuprofen were as follows:Cmax were (13.5 ±5.9) and (12.7±5.4) μg/mL; tmax were (5.1±1.0),(5.5±1.5) h; AUC0-24 were (100.2±45.4) and (98.5 ± 44.8) μg· h· mL-1;AUC0→∞ were (105.7 ± 47.3) and (103.8 ±47.0) μg· h· mL-1 for the reference drug and the test drug,respectively.The main pharmacokinetic parameters of muti dose of Ibuprofen were as follows:Cmax were (14.1±5.3) and (14.9±6.4) μg/mL;Cav were(8.2±3.4)and (8.6±4.3) μg/mL; tmax were (4.8±1.0) and (4.6±0.9) h; AUCss were (99.0±40.4) and (103.3±51.3) μg· h · mL-1 for the reference drug and the test drug,respectively.CONCLUSION:Statistic analysis shows that the reference preparation and the test preparation are bioequivalent.关键词
布洛芬/相对生物利用度/药代动力学Key words
Ibuprofen/ Relative bioavailability/Pharmacokinetics分类
医药卫生引用本文复制引用
田炜超,杨瑞,沈杰,谢海棠,王芳杰,肖坚..布洛芬缓释胶囊在健康人体的相对生物利用度研究[J].中国临床药理学与治疗学,2013,18(5):545-549,5.基金项目
湖南省自然科学重点项目(10JJ2008) （10JJ2008）
863计划项目(2012AA02A518) （2012AA02A518）
