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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。
Objective To evaluate the relative bioavailability and bioequivalence of levofloxacin capsules with levofloxacin as reference preparation. Methods Eight male healthy subjects were given oral single oral dose of 200 mg of levofloxacin. The plasma levofloxacin concentrations were determined by RP-HPLC. Results The AUC0 -2 4 of single oral dose of 200 mg levofloxacin capsules and tablets were (880.24 ± 172 8.39) ng · h · mL-1and (90 97.2 ± 15 5 ± 8.4) ng · h · mL-1; Cmax were (2042 ± 3197.19) ng · mL-1 and (175 1.01 ± 4.04) ng · mL-1, respectively; 6 ± 0.19) h and (0.84 ± 0.53) h respectively, the MRT was (8.15 ± 1.33) h and (9.03 ± 1.16) h, respectively; t1 / 2 β were ± 0.78) h and (6.79 ± 0.74) h, respectively. There was no significant difference in all pharmacokinetic parameters between the two preparations (P> 0.05), and the relative bioavailability F of levofloxacin capsules was ( 96 .77 ± 8.88)%. Conclusions Both formulations are bioequivalent.