盐酸加替沙星胶囊的人体药代动力学及生物等效性评价  

Equivalence Analysis on Pharmacokinetics and Bioavailability of Gatifloxacin HCL Capsules in Healthy Volunteers

作　　者：李宏力[1] 赵磊[2] 

机构地区：[1]陕西能源职业技术学院医学技术系,陕西西安710613 [2]第四军医大学西京医院临床药理基地,陕西西安710613

出　　处：《陕西能源职业技术学院学报》2007年第2期39-42,共4页

摘　　要：目的研究盐酸加替沙星胶囊在健康人体内的药代动力学特征及相对生物等效性。方法采用标准二阶段交叉设计自身对照试验法，将18例男性健康志愿者随机分为两组，单剂量口服盐酸加替沙星胶囊（试验品）或盐酸加替沙星片（参照品）各400mg，以高效液相色谱法测定受试者服药24h内血浆中加替沙星的经时浓度，计算药动学参数。以双单侧t检验统计法比较两种制剂参数间的差异。结果盐酸加替沙星在人体内的处置为一级吸收单室模型，两种制剂的药动学参数相近；试验品的相对生物利用度为105、2％。结论盐酸加替沙星具有吸收快、血药浓度较高、体内平均滞留时间（MRT）较长的特点；两种制剂具有生物等效性（P〉0．05）。AIM： To compare the pharmacokinetic parameters and bioavailability of gatifloxacin HCL 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 tested or referenced. The main pharmacokinetic parameters 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. The parameters of two formulations were similar. The relative bioavailability of tested was 105.2%. CONCLUSION： The Gatifloxacin HCL has characteristic of absorb quickly, high peak concentration in plasma and longer mean retention time and two formulations were bioequivalent（ P 〉 0.05 ）.

关 键 词：盐酸加替沙星胶囊 药动学 生物等效性 高效液相色谱 

分 类 号：R969.1[医药卫生—药理学]