加替沙星胶囊的药代动力学及生物等效性评价
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[摘要] 目的:研究两种加替沙星药剂的药代动力学参数,同时评估两者的生物等效性。方法:采用随机交叉,将36例男性健康志愿者随机分为两组,分别单剂量口服加替沙星胶囊400 mg(国产)和加替沙星片400 mg(进口),以高效液相色谱法测定受试者服药后血浆中加替沙星的经时浓度,计算加替沙星药动学参数,以双单侧t检验统计法比较两种甲磺酸加替沙星制剂是否具有生物等效性。结果:进口药物AUCo-t的90%可信限为国内药物相应参数的95.8%左右,Cmax的90%可信限为国内药物相应参数的95.6%左右。结论:加替沙星胶囊口服吸收迅速,血药浓度高,组织分布广,消除半衰期长,国产与进口加替沙星为生物等效制剂。
[关键词] 加替沙星;药代动力学;生物等效性
[中图分类号] R96 [文献标识码]A [文章编号]1673-7210(2010)01(a)-056-02
Assessment on pharmacokinetics and bioavailability of Gatifloxacin Capsules
JIANG Hongtao
(Women and Children Hospital in Dandong City, Dandong 118002, China)
[Abstract] Objective: To study pharmacokinetic parameters of two kinds of Gatifloxacin Capsules and assessment their bioavailability. Methods: An open, randomized, two-period crossover study was conducted in 36 healthy volunteers. Concentrations of gatifloxacin in plasma were assayed by HPLC after a single oral rose of 400 mg local Gatifloxacin Capsules or imported Gatifloxacin Capsules. The main pharmacokinetic parameters were analyzed by two one-sided t test ......
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