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健康人国产加替沙星片的药代动力学
Pharmacokinetics of gatifloxacin tablet in healthy volunteers
【摘要】 目的 :研究健康人口服加替沙星片后药代动力学特征。方法∶10名健康受试者单剂口服加替沙星片 2 0 0mg ,反相高效液相色谱法 (HPLC)测其血清、尿药物浓度。结果∶受试者单剂口服加替沙星片 2 0 0mg后 ,人体耐受良好 ,体内过程符合二室开放模型。药物口服后迅速吸收 ,达峰时间短 ,tmax为 (1.0 8± 0 .38)h ,血cmax为 (1.0 8± 0 .18)mg/L ,AUC0 -∞ 为 (9.0 1±0 .15 )mg·h/L ,V/Fc值为 (133.0 3± 36 .39)L/ 5 5kg。消除半衰期平均为 (7.84± 1.83)h ,48h尿累积回收率为 (6 2 .3± 8.0 )%。结论∶加替沙星口服吸收良好 ,血峰浓度高于敏感菌MIC值 ,组织分布广 ,2 0 0mg每日 1~ 2次口服可用于治疗常见敏感细菌感染。
【Abstract】 Objective: To study the pharmacokinetics of gatifloxacin tablet in healthy volunteers. Methods:A single-dose of 200?mg gatifloxacin were administered orally to ten healthy volunteers, serum and urine concentrations of gatifloxacin were detected by HPLC. Results:The concentration-time data after single oral dose of 200?mg gatifloxacin conformed to a two-compartment open model. The peak serum concentration reached at (1.08±0.38)?h, being (1.09±0.18)?mg/L, AUC 0-∞ was(9.01±0.15)?mg·h/L,V/Fc value was (133.03±36.39)?L/55?kg. The elimination half-life of gatifloxacin was (7.84±1.83)?h. (62.3±7.96)?% of the administered dose was recovered in the urine within 48?h. Conclusions: These results indicate that gatifloxacin has a favorable pharmacokinetic properties with high blood concentration and good tissue distribution. Once or twice daily dose of 200?mg may be used for the treatment of bacterial infections caused by susceptible organisms.
- 【文献出处】 中国抗感染化疗杂志 ,Chinese Journal of Infection and Chemotherapy , 编辑部邮箱 ,2002年02期
- 【分类号】R969
- 【被引频次】11
- 【下载频次】53