茶碱缓释干混悬剂在Beagle犬体内的药动学和生物等效性
发布时间:2018-05-13 15:14
本文选题:茶碱缓释干混悬剂 + 生物等效性 ; 参考:《中国医药工业杂志》2015年03期
【摘要】:研究茶碱缓释干混悬剂(受试制剂)和茶碱缓释片(参比制剂)在Beagle犬体内的药动学和生物等效性。进行双周期交叉试验,每条Beagle犬单次口服给予受试或参比制剂200 mg。建立了HPLC法测定Beagle犬血浆中的茶碱,用非房室模型分析得到参比制剂与受试制剂的主要药动学参数,分别为cmax(9.75±1.91)和(8.94±0.86)μg/ml,tmax(2.58±0.92)和(2.67±0.82)h,AUC0→t(76.59±9.51)和(75.22±15.06)μg·ml-1·h,AUC0→∞(79.55±9.86)和(77.08±13.44)μg·ml-1·h,t1/2(3.19±0.95)和(3.18±0.63)h,MRT(5.80±0.55)和(6.08±0.83)h。统计分析结果表明茶碱缓释干混悬剂与市售茶碱缓释片生物等效。
[Abstract]:The pharmacokinetics and bioequivalence of theophylline slow-release dry suspension (test preparation) and theophylline sustained-release tablets (reference preparation) in Beagle dogs were studied. Two-cycle cross-over test was conducted. Each Beagle dog was given a single oral dose of 200 mg. 寤虹珛浜咹PLC娉曟祴瀹欱eagle鐘娴嗕腑鐨勮尪纰,
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