芦氟沙星胶囊的人体药动学研究

A Study of the Pharmacokinetics of Rufloxacin Capsules in the Human Body

目的:测定盐酸芦氟沙星胶囊在人体内的药动学参数,为临床合理用药提供依据。方法:6例健康志愿者口服盐酸芦氟沙星胶囊200 mg后于不同时间取血,用高效液相色谱法(HPLC)测定血浆中芦氟沙星的血药浓度,按3P87药动学程序处理。结果:盐酸芦氟沙星胶囊口服后符合血管外口服一室开放模型,Tmax为(1.53±0.34)h,Cmax为(1.93±0.41)mg·L-1,浓度-时间曲线下面积(AUC)为(99.67±10.71)mg·h·L-1,t1/2为(34.16±8.55)h。结论:芦氟沙星血药浓度高,组织分布广,具有良好的药动学特征。

Objective: To determine the pharmacokinetic parameters of rufloxacin capsules in the human body in order to provide scientific basis for the rational clinical use of the drug. Methods: Plasma concentrations of rufloxacin were determined with high performance liquid chromatography at different times after 200 mg of rufloxacin capsules had been given PO to each of the 6 male healthy volunteers. The data were processed by the 3P87 pharmacokinetic program. Results:Rufloxacin was shown to accord with the one-compartment open model after oral administration. The mean achieved peak time ( Tmax) was (1.53 ±0.34) h;mean peak plasma concentration ( Cmax ) was (1. 93 ± 0. 41) mg · L-1 ; area under the curve ( AUC) was ( 99. 67 ± 10. 71) mg · h · L-1 ; and the half elimination time (t1/2), 34. 16 ± 8. 55 h. Conclusion: Rufloxin was shown to have a high blood concentration and a wide tissue distribution. The drug was absorbed completely and eliminated slowly, showring good pharmacokinetic features.