单剂量口服布洛芬控释片的药物动力学与相对生物利用度

Pharmacokinetics and relative bioavailability of ibuprofen controlled tablets

目的:研究单剂量po布洛芬控释片(A)与缓释胶囊(B)后,血清中的药物动力学与相对生物利用度.方法:采用HPLC法测定18名健康志愿者单剂量po600mgA与B后布洛芬血药浓度的变化,计算药物动力学参数与相对生物利用度,并以配对t检验与双单侧t检验进行统计分析.结果:单剂量po600mgA与B的t_(max)分别为(3.01±0.90)和(3.45±1.03)h;C_(max)分别为(16.73±3.28)和(16.05±3.56)mg/L;T_(1/2)分别为(5.23±0.86)和(5.28±0.72)h;AUC_(0→∞)分别为(175.89±35.93)和(181.80±41.10)mg·h/L.两种制剂的t_(max)、C_(max)和AUC(0→∞)均无显著差异(P>0.05).结论:两种制剂量给药600mg时为生物等效;以B为标准参比制剂,单剂量给药时A相对生物利用度为(97.37±9.98)%.

AIM:To study the pharmacokinetics and relative bioavailability of ibuprofen coutrolled tablets. METHODS: The serum concentration of ibuprofen was determined by HPLC in 18 volunteers after single oral administration 600mg ibuprofen controlled tablets (A) and ibuprofen sustained release capsules (B). RESULTS: t_(max) of the tablets and capsules were (3.01±0.90) and (3.45±1.03)h,c_(max)were (16. 73±3. 28)and (16. 05±3. 56)mg/L; T1/2 were (5. 23±0. 86)and (5. 28±0. 72)h;AUC0-∞were (175. 89±35. 93) and (181. 80± 41.10)mg · h/L,respectively. The results of statistical analysis showed that there was no significant difference of t_(max)c_(max)and AUCo-∞between the two preparations (P>. 05). CONCLUSION : The bioavailability of ibuprofen controlled tablets reference to ibuprofen sustained release capsules is (97. 37±9. 98)% in single oral administration.