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目的研究左旋氧氟沙星胶囊的人体药代动力学及相对生物利用度。方法12名健康志愿者随机交叉口服单剂量200mg 盐酸左旋氧氟沙星胶囊和左旋氧氟沙星片剂,采用高效液相色谱法测定左旋氧氟沙星血药浓度,用一级吸收的二室模型拟合血浓_时间数据,用方差分析和双单侧t检验进行制剂的等效性分析。结果胶囊的药代动力学参数为Cmax=(3.18±0.57)mg·L-1,tmax=(0.83±0.33)h,AUC0～24=(20.0±2.9)mg·h·L-1,t1/2(β)=(7.8±2.0)h;片剂的药代动力学参数为Cmax=(2.96±0.43)mg·L-1,tmax=(0.96±0.33)h,AUC0～24=(21.5±1.9)mg·h·L -1,t1/2(β) =(6.82±0.84)h,胶囊的相对生物利用度为(93.0±11.8) %。结论盐酸左旋氧氟沙星胶囊和左旋氧氟沙星片剂具有生物等效性
Objective To study the pharmacokinetics and relative bioavailability of levofloxacin capsules. Methods Twelve healthy volunteers were randomized to receive a single oral dose of 200mg levofloxacin capsules and levofloxacin tablets. The plasma concentrations of levofloxacin were determined by HPLC. The chamber model was fitted to the blood concentration-time data, and the analysis of the equivalence of the formulations was performed using analysis of variance and double unilateral t-test. Results The pharmacokinetic parameters of the capsule were Cmax = 3.18 ± 0.57 mg · L-1, tmax = 0.83 ± 0.33 h, AUC0-24 ± 20.0 ± 2.9 mg · h · L-1, t1 / The pharmacokinetic parameters of the tablets were Cmax = (2.96 ± 0.43) mg · L-1, tmax = (0.96 ± 0.33) h, AUC0-24 = (21.5 ± 1.9) mg · h · L -1 and t1 / 2 (β) = (6.82 ± 0.84) h respectively. The relative bioavailability of the capsules was (93.0 ± 11.8)%. Conclusion Levofloxacin hydrochloride capsules and levofloxacin tablets have bioequivalence