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目的:测定国产甲磺酸左氧氟沙星注射液在人体的药物动力学.方法:12名健康受试者恒速iv gtt 200mg/0.5h,用HPLC法测定血清中和尿液中甲磺酸左氧氟沙星浓度.结果:经药物动力学计算程序拟合,符合二室模型.其初始血药浓度C_0为(3.54±0.24)mg/L,T_(1/2β)为(6.53±0.96)h,CL为(14.063±2.639)L/h,V/F为(38.529±3.913)L,AUC为(14.63±2.41)[(mg/L)·h].24h内累积尿药排泄率为(62.97±5.86)%.各项药物动力学参数与国外文献报道基本相符.结论:甲磺酸左氧氟沙星国产与进口产品的体内处置过程相同.
OBJECTIVE: To determine the pharmacokinetics of levofloxacin mesylate injection in human.Methods: Twelve 200 mg / 0.5 h constant-dose iv gtt were given to healthy subjects, and the concentration of levofloxacin mesylate in serum and urine was determined by HPLC. Results: According to the pharmacokinetic calculation program fitting, the two-compartment model was established. The initial plasma concentration of C_0 was (3.54 ± 0.24) mg / L, T 1/2 1/2 (6.53 ± 0.96) h and CL was (14.063 ± 2.639) L / h, V / F was (38.529 ± 3.913) L and AUC was (14.63 ± 2.41) [(mg / L) · h]. The urinary excretion rate within 24 hours was (62.97 ± 5.86)%. The pharmacokinetic parameters were in good agreement with those reported in foreign literature.Conclusion: Levofloxacin mesylate is the same as the in vivo disposal of imported products.