奥沙普秦分散片的人体相对生物利用度

Relative bioavailability of oxaprozin dispersible tablet in healthy volunteers

目的 :研究奥沙普秦分散片在健康人体的相对生物利用度 ,为临床更合理用药提供理论依据。方法 :采用 HPL C法测定了 18名健康志愿者口服奥沙普秦分散片和普通片各 40 0 m g后不同时间的血药浓度 ,并进行生物等效性评价。结果 :奥沙普秦分散片剂和普通片的 cmax分别为 ( 70 .5 8± 7.6 0 ) ︼g/ml和 ( 6 5 .89± 8.2 2 ) ︼g/ml;tmax分别为 ( 3.2 2± 0 .43) h和 ( 3.44± 0 .5 1)h;T1 / 2 分别为 33.18h和 2 9.41h;AUC(0 - 96h) 为 ( 2 741.6± 393.6 )︼g/ml· h和 ( 2 5 6 1.8± 375 .7)︼g/ml· h。奥沙普秦分散片剂的人体相对生物利用度为 ( 10 4.0 2± 4.0 5 ) %。结论 :奥沙普秦分散片剂与普通片具有生物等效性。

AIM: To study relative bioavailability of oxaprozin dispersible tablet in healthy volunteers. METHODS: The study was carried out in 18 healthy volunteers after receiving a single dose of 400 mg oxaprozin dispersible tablet and domestic tablet. The blood drug concentration was determined by high performance liquid chromatography (HPLC), and the pharmacokinetic parameters were calculated and the bioavailability was evaluated. RESULTS: The pharmacokinetic parameters for dispersible tablet (T) and tablet (R) were as follows: c max was (70 58±7 60) μg/ml and (65 89±8 22) μg/ml, t max was (3 22±0 43) h and (3 44±0 51) h, T 1/2 was 33 18 h and 29 41 h, AUC (0 96h) was ( 2 741 6 ±393 6) μg/ml·h and ( 2 561 8 ±375 7) μg/ml·h, respectively. The relative bioavailability for oxaprozin dispersible tablet was (104 02±4 50)% compared with tablet. CONCLUSION: Oxaprozin dispersible tablet and domestic tablet are bioequivalent.