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本文报道8例健康志愿者交叉口服两个药厂生产的布洛芬的人体生物利用度及药代动力学研究,用反相高效液相色谱法测定人血清中布洛芬浓度。单剂量空腹口服布洛芬颗粒剂和糖衣片剂400mg后,体内过程符合单室模型.达峰时间为1.85±0.40h和27.44±7.35h;峰浓度为25.65±5.27mgL(-1)和27.44±7.35mgL(-1);曲线下的面积为136.08±27.13mgL(-1)h和142.74±32.13mgL(-1)h;消除半衰期为1.98±0.35h和1.98±0.30h。以对照制剂为标准,样品制剂的相对生物利用度为95.33%,两药的主要药代动力学参数无显著性差异(p>0.05)。
In this paper, we report the bioavailability and pharmacokinetics of ibuprofen produced by two pharmaceutical factories in eight healthy volunteers. The concentration of ibuprofen in human serum was determined by RP-HPLC. After a single dose of fasting oral ibuprofen granules and sugar-coated tablets 400mg, the in vivo process in line with the single-chamber model. The peak time was 1.85 ± 0.40h and 27.44 ± 7.35h respectively; the peak concentrations were 25.65 ± 5.27mgL (-1) and 27.44 ± 7.35mgL (-1) The area was 136.08 ± 27.13mgL (-1) h and 142.74 ± 32.13mgL (-1) h, the elimination half-lives were 1.98 ± 0.35h and 1.98 ± 0.30h respectively. The relative bioavailability of the sample preparation was 95.33% based on the control formulation. The main pharmacokinetic parameters of the two drugs showed no significant difference (p> 0.05).