酮洛芬缓释片人体药动学和生物等效性研究

Pharmacokinetics and Bioequivalence of Ketoprofen Sustained Released Tablet in Healthy Volunteers

目的:评价受试酮洛芬缓释片与参比酮洛芬片的生物等效性。方法:采用反相高效液相色谱法测定24名健康男性志愿受试者交叉单剂量口服受试酮洛芬缓释片与参比酮洛芬片150mg后血浆中酮洛芬的浓度,用3p97程序进行数据处理。结果:口服受试和参比酮洛芬制荆后的AUC_(0-(?))分别是38.94±9.15μg·h·ml^(-1)、38.04±6.90μg·h·ml^(-1);AUC_(0-(?))分别是44.50±8.09μg·h·ml^(-1)、42.99±8.36μg·h·ml^(-1);T_(max)分别是3.87±0.55 h、1.96±0.60h;C_(max)分别是5.78±1.11μg·ml^(-1)、11.62±2.10μg·ml^(-1);t_(1/2)(Ke)分别是5.88±1.16h、1.70±1.40h。结论:受试酮洛芬缓释片与参比酮洛芬片具有生物等效性。

Objective： To study the pharmacokinetic profile and relative bioavailability of ketoprofen sustained release tablet in healthy volunteers. Methods： A single oral dose of test ketoprofen sustained release tablets and conventional ketoprofen tablets were given to 24 healthy male volunteers according to an open randomized two way crossover design. Ketoprofen concentrations in plasma were determined by HPLG method. The data were analyzed by 3p97 program. Results： The main pharmacokinetic parameters after a single oral dose of test tablets and conventional tablets were as follows： AUC0→t was 38.94± 9.15μg·h·ml^-1 and 38.04± 6.90μg·h·ml^-1,AUG0→∞ was 44.50± 8.09μg·h·ml^-1 and 42.99± 8.36μg·h·ml^-1,Tmax was 3.87± 0.55h and 1.96± 0.60 h, Gmax was 5.78± 1.11μg·ml^-1 and 11.62± 2.10μg·ml^-1, t1/2 Ke） was 5.88±1.16h and 1.70±1.40h, respectively. Conclusion： The two preparations of ketoprofen are of bioequivalence by analysis of variance.