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尼扎替丁分散片与尼扎替丁普通片在健康人体内的药代动力学研究

Pharmacokinetics comparison between nizatidine dispersible tablets and nizatidine conventional tablets in healthy volunteers
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摘要 目的比较尼扎替丁分散片与尼扎替丁普通片在健康人体内药代动力学行为。方法 12名男性健康志愿者均分为2组,分别单剂量口服尼扎替丁分散片与尼扎替丁普通片150 mg,用高效液相色谱法检测尼扎替丁的血药浓度。结果尼扎替丁分散片与尼扎替丁普通片主要药代动力学参数Cmax分别为(1614.8±106.2)μg/L和(1 311.7±89.5)μg/L,tmax分别为(1.0±0.6)h和(1.5±0.4)h,t1/2分别为(4.8±1.3)h和(5.3±1.1)h,AUC0∞分别为(4731.3±118.29)μg/(h.L)和(4518.6±108.3)μg/(h.L),AUC0t分别为(2216.7±106.9)μg/(h.L)和(2187.4±78.9)μg/(h.L)。结论尼扎替丁分散片的tmax、t1/2明显小于普通片,Cmax又明显高于普通片,说明尼扎替丁分散片具有良好的速释效果。 Objective To compare the pharmacokinetics of nizatidine dispersible tablets and nizatidine conventional tablets in healthy volunteers.Methods 12 healthy male volunteers were divided into two groups,who received a single oral dose of 150 mg nizatidine dispersible tablets and nizatidine conventional tablets,respectively.The plasma concentrations of nizatidine were determined by HPLC,and the data was analyzed by using DAS 2.1.Results The main pharmacokinetic parameters of nizatidine dispersible tablets and nizatidine tablets were as follows: Cmax were(1614.8±106.2) μg/L and(1 311.7±89.5) μg/L,tmax were(1.0±0.6) h and(1.5±0.4) h,t1/2 were(4.8±1.3) h and(5.3±1.1) h,AUC0∞ were(4 731.3±118.29) μg/(h·L) and(4 518.6±108.3) μg/(h·L);AUC0t were(2 216.7±106.9) μg/(h·L) and(2 187.4±78.9) μg/(h·L) respectively.Conclusions tmax and t1/2 of nizatidine dispersible tablets were significantly shorter than those of nizatidine conventional tablets,and Cmax of nizatidine dispersible tablets was significantly higher than that of nizatidine conventional tablets.It suggested that nizatidine dispersible tablets had a property of quick release.
作者 冒群
出处 《实用临床医药杂志》 CAS 2011年第1期101-103,共3页 Journal of Clinical Medicine in Practice
关键词 尼扎替丁 分散片 血药浓度 药代动力学 nizatidine dispersible tablet plasma drug concentration pharmacokinetics
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