加替沙星胶囊的药代动力学及生物等效性评价  

Assessment on pharmacokinetics and bioavailability of Gatifloxacin Capsules

作　　者：姜洪涛 

机构地区：[1]丹东市妇女儿童医院,辽宁丹东118002

出　　处：《中国医药导报》2010年第1期56-57,共2页China Medical Herald

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400mg(国产)和加替沙星片400mg(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。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 phamlacokinetic parameters were analyzed by two one-sided t test. Results： Compared local Gatifloxacin Capsules, 90% confidence limit of AUCo-t and Cmax of imported Gatifloxacin Capsules was 95.8% times and 95.6% times, respectively. Conclusion： The Gatifloxacin Capsules has characteristic of quick absorption, high peak concentration in plasma and longer mean retention times. The restult of statistical analysis showed that two formulations were bioequivalent.

关 键 词：加替沙星 药代动力学 生物等效性 

分 类 号：R96[医药卫生—药理学]