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本文报道8例健康青年志愿者交叉口服两个药厂生产的吉非罗齐胶囊的生物利用度研究。用反相高效液相色谱法测定人血浆中吉非罗齐的浓度。单剂量口服两种胶囊900mg后,体内过程符合单室模型。达峰时间为1.781±0.550和1.995±0.692h;峰浓度为17.457±5.304和16.646±6.474mg·L-1;曲线下面积为79.641±16.816和81.817±21.573mg·L-1·h。以对照制剂为标准,样品制剂的相对生物利用度为102.732%,两药的主要药代动力学参数无显著性差异(p<0.05)。
This article reports the bioavailability of gemfibrozil capsules produced by two pharmaceutical factories at the crossing of eight healthy young volunteers. Determination of Gemfibrozil Concentration in Human Plasma by Reversed Phase High Performance Liquid Chromatography. After a single dose of oral administration of two capsules 900mg, in vivo process consistent with single-chamber model. Peak time was 1.781 ± 0.550 and 1.995 ± 0.692h; peak concentrations were 17.457 ± 5.304 and 16.646 ± 6.474mg · L-1, respectively. The area under the curve was 79.641 ± 16.816 and 81.817 ± 21.573 mg · L -1 · h. The relative bioavailability of the sample preparation was 102.732% based on the control formulation, with no significant difference in the main pharmacokinetic parameters (p <0.05).