加替沙星片的人体药代动力学及生物等效性研究  

Clinical Pharmacokinetics and Bioequivalence of Gatifloxacin

作　　者：吕向群 黄敏珠[2] 

机构地区：[1]浙江永康市第一人民医院,浙江永康321300 [2]解放军第117医院

出　　处：《中国药师》2007年第5期430-432,共3页China Pharmacist

摘　　要：目的:研究国产加替沙星片在健康志愿者中的药物动力学及生物等效性和安全性。方法:选择24名健康成年男性受试者,随机分为2组,单次空腹口服国产或进口片剂400mg,采用HPLC法测定其血药和尿药浓度。结果:单剂量空腹口服国产和进口加替沙星片剂后体内过程均符合血管外二室模型,C_(max)分别为(4.15±1.04)mg·L^(-1)和(3.95±0.75)mg·L^(-1),t_(max)分别为(0.75±0.30)h和(0.75±0.32)h,t_(1/2)为(6.77±1.58)h和(7.18±0.98)h,AUC_(0-t)分别为(31.83±3.84)mg·h·L^(-1)和(32.41±3.81)mg·h·L^(-1)。48 h内平均累积尿排出率分别为(79.53±5.79)%和(79.89±6.09)%。结论:国产片剂与进口片剂相比,主要药物动力学参数经统计学处理均无显著性差异,其相对生物利用度为(98.41±7.62)%。Objective： To evaluate the pharmacokinetic and the bioequivalence of domestic gatifloxacin. Method： A single oral dose of 400rag of gatifloxacin of domestic or imported tablet was given to 24 healthy male volunteers. The gatifloxacin concentrations in plasma and urine was determined by HPLC method. Result： The concentration-time curve of gatifloxacin was accorded with two - compartment model. The Cm,, of domestic and imported were （4.15 ± 1,04 ）mg· L^-1 and （ 3.95 ±0.75 ） mg· L^-1, t max were （ 0.75 ± 0.30 ） h and （0.75 ±0,32）h, t1/2 were （6.77 ± 1.58）h and （7.18 ±0.98）h, AUC（0-1） were （31.83 ±3.84）mg· L^-1 and （32.41 ± 3.81 ） mg· L^-1 respectively. The cumulative urinary excretion rate in 48 h were （ 79.53 ± 5.79 ） % and （ 79.89 ± 6.09 ） % respectively. Conclusion： Compared with imported tablet, the differences of the main pharmacokinetic parameters of the domestic tablet were not statistically significant （P 〉 0.05 ）. The relative bioavailability of domestic gatifloxicin tablet was（98.41 ± 7.62）%.

关 键 词：加替沙星 药物动力学 生物等效性 

分 类 号：R969.1[医药卫生—药理学]