乳酸左氧氟沙星片的人体生物利用度

Bioavailability of levofloxacin lactate tablets in healthy volunteers

目的;测定乳酸左氧氟沙星片的相对生物利用度.方法:8名男性健康志愿者交叉po 200mg国产和进口乳酸左氧氟沙星片,采用HPLC法测定血浆中左氧氟沙星的浓度.结果:两种片剂的血药浓度曲线均符合二室模型.其主要药物动力学参数:Ka分别为(0.70±0.26)和(0.68±0.281)h^(-1).T_(1/2)分别为(5.93±3.03)和(4.43±0.66)h,AUC分别为(11.13±2.81)和(11.18±2.89)μg·h/ml.两种片剂药物动力学参数均无明显差异(P>0.05),国产乳酸左氧氟沙星片的相对生物利用度为100.60%.结论:两种片剂生物等效.

AIM: To study the bioavailability of levofloxacin lactate tablets in 8 normal male volunteers. METHODS;A single oral dose of 200mg domestic or imported levofloxacin was given according to a crossover design. The concentrations in plasma were determined by high performance liquid chromatography. RESULTS: The concentration-time curves of domestic and imported products fitted to two-compartment open model. The main pharma-cokinetic parameters were Ka (0. 70±0. 26)and (0. 68±0. 281)h^(-1),the T1/2(5. 93±3. 03)and (4. 43±0. 66)h,the AUC (11.13±2.81)and (11.18±2. 89)μg · h/ml,respectively. The pharmacokinetic parameters obtained from our studies showed no significant difference between two products(P>0. 05).The relative bioavailability of domestic to imported tables-157-was 100. 60%. CONCLUSION:Two preparations are bioequivalent.