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目的:测定噁丙嗪的体内过程,作出相对生物利用度评价,为临床合理用药提供可靠的依据.方法:10名男性健康志愿者,随机自身交叉po单剂量噁丙嗪胶囊或片剂,采用HPLC法测定不同时间的血药浓度,经3P87软件拟合处理,并计算药物动力学参数.结果:噁丙嗪胶囊和片剂血药浓度-时间曲线均符合一房室模型,体内药物达峰时间分别为(3.95±0.89)和(4.13±0.93)h;c_(max)分别为(52.84±3.12)和(53.74±2.32)μg/ml;T_(1/2)分别为(29.36±1.69)和(28.73±2.27)h;AUC分别为(2453.54±150.78)和(2486.71±187.38)(mg/L)·h,噁丙嗪胶囊的相对生物利用度为98.93%.结论:两种制剂具有生物等效性.
OBJECTIVE: To determine the in vivo process of oxaprozin and to make a relative bioavailability evaluation to provide a reliable basis for rational clinical use.Methods: Ten male volunteers were randomized to crossover single dose oxaprozin capsules or tablets HPLC method was used to determine plasma concentration at different time and the pharmacokinetic parameters were calculated by 3P87 software.Results: The plasma concentration-time curves of oxaprozin capsules and tablets were in accordance with one-compartment model and reached peak in vivo Time was (3.95 ± 0.89) and (4.13 ± 0.93) h respectively; c max was (52.84 ± 3.12) and (53.74 ± 2.32) μg / ml respectively; T 1/2 was 29.36 ± 1.69 And (28.73 ± 2.27) h, AUC was (2453.54 ± 150.78) and (2486.71 ± 187.38) (mg / L) · h respectively, and the relative bioavailability of oxaprozin capsules was 98.93% .Conclusion: Equivalence.