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注射用头孢拉宗在中国健康人体的药代动力学研究

发布时间:2018-07-21 15:57
【摘要】:目的研究注射用头孢拉宗在中国健康人体的药代动力学。方法用开放、随机、自身三交叉对照试验设计。12名受试者分别接受单次静脉滴注头孢拉宗1.0,2.0,3.0 g,通过高效液相色谱法测定头孢拉宗浓度。用WinNonlin5.2.1计算药代动力学参数。结果头孢拉宗的线性范围为2~250μg·mL~(-1),头孢拉宗1.0,2.0,3.0 g的主要药代动学参数:C_(max)分别为(81.74±15.95),(145.47±42.22),(198.16±36.03)μg·mL~(-1),t_(max)分别为(1.01±0.03),(1.02±0.04),(1.01±0.03)h;t_(1/2)分别为(1.80±0.30),(1.88±0.31),(1.74±0.27)h;AUC_(0-t)分别为(136.37±43.31),(263.74±93.95),(335.76±68.47)μg·mL~(-1)·h。16 h后的尿药累积排泄率分别为(45.24±17.50)%,(48.27±15.18)%,(40.82±14.24)%。结论受试者单次静脉滴注头孢拉宗1.0,2.0,3.0 g后药物体内过程呈一级线性动力学特征。
[Abstract]:Objective to study the pharmacokinetics of cefradine for injection in Chinese healthy volunteers. Methods Cefradazon concentration was determined by high performance liquid chromatography (HPLC) in 12 subjects who received a single intravenous drip of cefradazone 1.0 ~ 2.0 ~ 3.0 g in an open, randomized, self-controlled triple-controlled trial. The pharmacokinetic parameters were calculated with WinNonlin 5.2.1. 缁撴灉澶村鎷夊畻鐨勭嚎鎬ц寖鍥翠负2~250渭g路mL~(-1),澶村鎷夊畻1.0,2.0,3.0 g鐨勪富瑕佽嵂浠e姩瀛﹀弬鏁,

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