【摘要】 目的　以左氧氟沙星片为参比制剂 ,评价左氧氟沙星胶囊的相对生物利用度和生物等效性。方法　 8名男性健康受试者交叉单剂量口服 2 0 0mg两种制剂 ,采用RP HPLC测定血浆中左氧氟沙星浓度。结果　单剂量口服 2 0 0mg左氧氟沙星胶囊和片剂后的AUC0 -2 4分别为 (880 2 .4 1± 172 8.39)ng·h·mL-1和 (90 97.2 5± 15 5 8.4 0 )ng·h·mL-1;Cmax分别为 (2 0 4 2 .31± 6 97.19)ng·mL-1和 (175 1.0 1± 4 0 0 .4 2 )ng·mL-1;tmax分别为 (0 .6 6± 0 .19)h和 (0 .84± 0 .5 3)h ,MRT分别为 (8.15± 1.33)h和 (9.0 3± 1.16 )h ;t1/ 2 β分别为 (6 .5 2± 0 .78)h和 (6 .79± 0 .74 )h ,两种制剂所有药物动力学参数均无显著性差异 (P >0 .0 5 ) ,左氧氟沙星胶囊的相对生物利用度F为 (96 .77± 8.88) %。结论　两种制剂生物等效。更多还原

【Abstract】 OBJECTIVE Compared with levofloxacin tablet to evaluate the relative bioavailability and bioequivalence of levofloxacin capsule. METHOD 8 male health volunteers orally took a single dose of 200mg levofloxacin capsule and tablet in cross ways. The plasma concentrations of levofloxacin were determined by RP-HPLC.RESULTS The pharmacokinetic parameters of levofloxacin capsule and tablet were as follows: AUC 0-24 (8802.41±1728.39)ng·h·mL -1 and (9097.25±1558.40)ng·h·mL -1; C max (2042.31±697.19)ng·mL -1 and (1751.01±400.42)ng·mL -1; t max (0.66±0.19)h and (0.84±0.53)h; MRT (8.15±1.33)h and (9.03±1.16)h; t 1/2β (6.52±0.78)h and (6.79±0.74)h, respectively. There was no statistical difference between levofloxacin capsule and tablet in pharmacokinetic parameters (P>0.05). The relative bioavailability of levofloxacin capsule was (96.77±8.88)%. CONCLUSION Two preparations of levofloxacin are bioequivalent.更多还原