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报道了16名健康志愿者(A 组8名,B 组8名)体内单次及多次给与200 mg 和300 mg 洛氟沙星(可乐必妥,LVFX)后的药代动力学研究。血及尿药浓度均采用 HPLC 测定。单次及多次给药的数据分别采用3P87及 SSD 程序处理,药-时曲线符合二室模型。A、B 组分别单次口服200 mg 与300 mg LVFX,平均达峰时间分别为1.18和1.43 h;血药峰浓度分别是2.87和4.20 mg/L;消除半衰期分别为6.11和6.06h;药-时曲线下面积分别为19.49和38.86(mg·h)/L。0～24 h 尿药回收率分别为66.28%和66.43%。经 t 检验两组峰浓度和药-时曲线下面积有显著性差异(P<0.05)。在200 mg/d q8h 和300 mg q12h 连续8d 的多次口服给药实验中,d1与 d8的药代动力学参数经 t检验无显著性差异(P>0.05),说明本品600 mg/d 的重复给药无明显蓄积性。
Reported pharmacokinetic studies of 16 healthy volunteers (8 in group A, 8 in group B) with single and multiple injections of 200 and 300 mg of loofloxacin (colabitol, LVFX) in vivo. Blood and urine concentrations were determined by HPLC. Single and multiple dosing data were processed using 3P87 and SSD programs, respectively, and the drug-time curve was in accordance with the two-compartment model. Group A and group B received 200 mg and 300 mg LVFX orally respectively for one time and the average peak time was 1.18 and 1.43 h respectively; the peak plasma concentrations were 2.87 and 4.20 mg / L respectively; the elimination half-lives were 6.11 and 6.06 h; When the area under the curve were 19.49 and 38.86 (mg · h) / L. Urine drug recovery rates at 0-24 h were 66.28% and 66.43%, respectively. There was a significant difference (P <0.05) between peak concentration and area under the curve of drug-time under t-test. Pharmacokinetic parameters of d1 and d8 showed no significant difference (t> 0.05) in multiple oral administrations of 200 mg / d q8h and 300 mg q12h for 8 days, indicating that the product 600 mg / d Repeated administration without significant accumulation.