甲磺酸加替沙星__(期刊论文)

甲磺酸加替沙星胶囊人体药代动力学及生物等效性评价

http://www.100md.com 《第四军医大学学报》 2005年第20期

甲磺酸加替沙星,,甲磺酸加替沙星；药代动力学；生物利用度；色谱法，高压液相,1材料和方法,2结果,3讨论,【参考文献】

     Assessment on pharmacokinetics and bioavailability of gatifloxacin mesylate capsules in healthy volunteers

    LI HongLi， FAN DaiMing， LI Zhe， WEN AiDong， ZHAO Lei， WU Yin， GUO Zheng， SHI Ru

    Clinical Pharmacology Base, Xijing Hospital, Fourth Military Medical University Shaanxi, Xian 710033, China

    【Abstract】 AIM: To study the pharmacokinetic parameters and bioavailability of gatifloxacin mesylate capsules. METHODS: An open, randomized, twoperiod crossover study was conducted in 18 healthy volunteers. Concentrations of gatifloxacin in plasma were assayed by HPLC after a single oral dose of 400 mg of the tested capsules or the referenced tablets. The main pharmacokinetic parameters [AUC(0-24h), Cmax and Tmax] were analyzed by two onesided t test. RESULTS: The concentrationtime curve after medication conformed to onecompartment open model with a first order absorption. Tmax, Cmax and AUC(0-24h) of the tested capsules and the referenced tablet were(1.51±0.39) and (1.54±0.40) h, (3.48±0.84) and (3.43±0.96) mg·L-1，(34.51±8.49) and (33.04±10.25)mg·h·L-1 respectively. The relative bioavailability of the tested capsules tothe referenced tablets was 107.4%. CONCLUSION: The gatifloxacin mesylate has characteristic of quick absorption, high peak concentration in plasma and longer mean retention time; The result of statistical analysis showed that two formulations were bioequivalent (P>0.05). ......

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