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比较了头孢克罗缓释片和普通胶囊的药物动力学和生物利用度,8名健康志愿者随机交叉单剂量po750mg缓释片和普通胶囊,采用HPLC法测定血浆和尿中头孢克罗浓度,缓释片和普通胶囊的药动学参数为Cmax7.26±1.08和15.44±3.73μg/ml;Tmax1.13±0.23和0.72±0.16h;t1/20.94±0.19和0.63±0.08h;MRT2.51±0.45和1.35±0.25h,AUC21.65±3.31和22.24±3.68hμg/ml。AUC及其对数形式经三因素方差分析和双单侧检验,两种制剂均无显著性差异,缓释片的相对生物利用度为(98.23±13.73)%。
The pharmacokinetics and bioavailability of cefaclor sustained-release tablets and ordinary capsules were compared. Eight healthy volunteers were randomized to cross a single dose of po750mg sustained-release tablets and ordinary capsules. Plasma and urinary cefaclor concentrations were determined by HPLC. The pharmacokinetic parameters of sustained-release tablets and ordinary capsules were Cmax7.26 ± 1.08 and 15.44 ± 3.73μg / ml; Tmax1.13 ± 0.23 and 0.72 ± 0.16h; t1 / 20. 94 ± 0.19 and 0.63 ± 0.08 h; MRT 2.51 ± 0.45 and 1.35 ± 0.25 h, AUC 21.65 ± 3.31 and 22.24 ± 3.68 hμg / ml. AUC and its logarithmic form by three-factor analysis of variance and double unilateral test, no significant difference between the two preparations, the relative bioavailability of sustained-release tablets was (98.23 ± 13.73)%.