酮洛芬缓释胶囊剂的生物利用度研究

Studies on Pharm acokinetics and Bioavailability of Ketoprofen Slo w release Capsules

８ 名健康受试者单剂量和多剂量交叉口服酮洛芬缓释胶囊的试验制剂和参比制剂。单剂量试验结果表明，达峰时间分别为５ ．６８ ±１ ．７３ ｈ 和６ ．５８ ±１ ．９２ ｈ ，峰浓度分别为３ ．９１ ±１ ．１３ μｇｍｌ 和３ ．１５ ±０ ．７９ μｇｍｌ ，两种制剂的药动学参数无显著性差异，试验制剂的相对生物利用度为（９９ ．９７ ±９ ．６３） ％ 。多剂量试验研究表明，试验制剂和对照制剂的波动系数分别为２ ．５６ ±０ ．４７ 和２ ．５５ ±０ ．７３ ，经统计学处理无显著性差异，表明两种制剂的安全性相当。

The pharmacokinetics and relative bioavailability ofthe two kinds of ketoprofen slow release capsules wereinvestigated in 8 healthy volunteers . Drug concentrations in plasma were assayed by H P L C method . The peakconcentrations( Cm ax ) of ketoprofen test formulation and control formulation were 3 .91 ±1 .13 μgml and 3 .15 ±0 .79μgml ,respectively . The relative bioavailability of ketoprofen testformulation was (99 .97 ±9 .63) % . After multipledosing ,the fluctuation indexes( F I) for the two formulations were 2 .56 ±0 .47 and 2 .54 ±0 .73 ,respectively . Theresults showed that the ketoprofen test formulation and control formulation were bioequivalent.