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洛美沙星制剂在中国10名健康志愿者体内的药代动力学及相对生物利用度

Pharmacokinetics and relative bioavailability of lomefloxacin preparations in 10 healthy Chinese volunteers.

作者信息

Diao Y, Lu J, Li L, Zhu X D, Ji G, Wang E H

机构信息

Nanjing Command Institute for Drug Control, China.

出版信息

Zhongguo Yao Li Xue Bao. 1993 May;14(3):247-9.

PMID:8237402
Abstract

The pharmacokinetics of lomefloxacin tablet and capsule were determined following a single oral dose of 400 mg given to each of 10 Chinese healthy male volunteers in an open, randomized crossover study. Drug concentrations in plasma were assayed by HPLC method. The peak levels in plasma averaged 6.0 +/- 1.3 and 5.9 +/- 1.0 micrograms.ml-1 at 1.3 +/- 0.4 and 1.2 +/- 0.4 h, and the areas under the drug concentration curves were 43 +/- 15 and 44 +/- 13 h.micrograms.ml-1 for lomefloxacin tablet and capsule, respectively. The concentration-time courses after medication conformed to a 1-compartment open model with a first order absorption. Pharmacokinetic parameters after tablet did not differ significantly from the corresponding values after capsule. The bioavailability of tablet was comparable to that of capsule.

摘要

在一项开放、随机交叉研究中,对10名中国健康男性志愿者每人单次口服400mg洛美沙星片和胶囊后,测定了其药代动力学。采用高效液相色谱法测定血浆中的药物浓度。血浆中的峰值水平在1.3±0.4小时和1.2±0.4小时时平均分别为6.0±1.3和5.9±1.0μg.ml-1,洛美沙星片和胶囊的药物浓度曲线下面积分别为43±15和44±13 h.μg.ml-1。用药后的浓度-时间过程符合一级吸收的单室开放模型。片剂后的药代动力学参数与胶囊后的相应值无显著差异。片剂的生物利用度与胶囊相当。

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