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采用高效液相色谱法(HPLC)测定盐酸环丙沙星的血药浓度。色谱条件为:紫外检测波长λ277nm;分析柱为HP-RP-ODSC18柱,Φ4.6×220mm;流动相:乙腈∶(溴化四丁基铵0.008mol·L-1+磷酸二氢钾水溶液0.011mol·L-1)=14∶86,配好后磷酸调pH至2.74±0.02。本法血清最低检出浓度0.01μg·ml-1。对10名受试者口服500mg两种盐酸环丙沙星片后进行药动学和生物利用度研究。药-时曲线经拟合为二室开放模型,其T1/2β分别为4.68±0.53h与4.40±0.47h,Tmax分别为1.28±0.07h与1.33±0.07h,Cmax分别为6.44±0.61(μg·ml-1)与5.88±0.40(μg·ml-1),AUC分别为19.88±1.83(μg·h-1·ml-1)和19.24±1.08(μg·h-1·ml-1)。供试品片剂的相对生物利用度为103.32±4.81%(99.58±4.63%,经含量校正),经统计分析两种制剂具有生物等效性。
The plasma concentrations of ciprofloxacin hydrochloride were determined by high performance liquid chromatography (HPLC). The chromatographic conditions were: UV detection wavelength λ277nm; analytical column HP-RP-ODSC18 column, Φ4.6 × 220mm; mobile phase: acetonitrile: tetrabutyl ammonium bromide 0.008mol·L-1 + .011mol·L-1) = 14:86, with a good pH adjusted to pH 2.74 ± 0.02. The minimum detectable serum concentration of 0.01μg · ml-1. Pharmacokinetics and bioavailability of two ciprofloxacin hydrochloride tablets (500 mg) were orally administered to 10 subjects. The drug-time curve was fitted to a two-compartment open model with T1 / 2β of 4.68 ± 0.53h and 4.40 ± 0.47h, Tmax of 1.28 ± 0.07h and 1.33 ± 0.07h, Cmax were 6.44 ± 0.61 (μg · ml-1) and 5.88 ± 0.40 (μg · ml-1) respectively, AUC were 19.88 ± 1.83 h-1 · ml-1) and 19.24 ± 1.08 (μg · h-1 · ml-1). The relative bioavailability of the tested tablets was 103.32 ± 4.81% (99.58 ± 4.63%, corrected by content), and the bioavailability of the two preparations was statistically analyzed.