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目的:研究国产盐酸左氧氟沙星片的人体相对生物利用度与生物等效性。方法:20名男性健康志愿者随机交叉单剂量口服国产盐酸左氧氟沙星受试和参比制剂(彼妥)200 mg,采用反相高效液相色谱法测定其血药浓度,计算其药动学参数和相对生物利用度,评价2种制剂的生物等效性。结果:国产盐酸左氧氟沙星受试和参比制剂的主要药动学参数:t_(1/2)分别为(7.37±0.88),(7.39±0.96)h;t_(max)分别为(1.13±0.30),(1.06±0.24)h;C_(max)分别为(2.08±0.42),(2.03±0.35)mg·L~(-1);AUC_(0～24)分别为(13.17±2.32),(13.73±2.89)mg·h·L~(-1)。国产盐酸左氧氟沙星受试制剂的相对生物利用度为(97.7±16.7)%。结论:2制剂具有生物等效性。
Objective: To study the relative bioavailability and bioequivalence of domestic levofloxacin hydrochloride tablets. Methods: Twenty healthy male volunteers were randomized to receive a single oral dose of levofloxacin hydrochloride (200 mg) and a reference formulation (bortezin). The plasma concentrations were determined by RP-HPLC. The pharmacokinetic parameters and Relative bioavailability was evaluated for bioequivalence of the two formulations. Results: The main pharmacokinetic parameters of domestic levofloxacin hydrochloride test and reference preparation were: t 1/2 (7.37 ± 0.88) and (7.39 ± 0.96) h, t max respectively (1.13 ± 0.30) (1.06 ± 0.24) h and (Cmax) were (2.08 ± 0.42) and (2.03 ± 0.35) mg · L -1, respectively; AUC 0-24 were 13.17 ± 2.32 and 13.73 respectively ± 2.89) mg · h · L -1. The relative bioavailability of domestic levofloxacin hydrochloride preparations was (97.7 ± 16.7)%. Conclusion: 2 formulations have bioequivalence.