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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)%.
OBJECTIVE: To study the pharmacokinetics and relative bioavailability of single-dose po, ibuprofen controlled-release tablets (A) and sustained-release capsules (B) in serum.METHODS: A single dose of po600mgA And B after ibuprofen plasma concentration changes pharmacokinetic parameters and relative bioavailability calculated by paired t-test and double unilateral t-test statistical analysis.Results: single dose po600mgA and B t_ (max) Were (3.01 ± 0.90) and (3.45 ± 1.03) h respectively; C max were (16.73 ± 3.28) and (16.05 ± 3.56) mg / L respectively; T 1/2 was 5.23 ± 0.86 and (5.28 ± 0.72) h and AUC_ (0 → ∞) were (175.89 ± 35.93) and (181.80 ± 41.10) mg · h-1 respectively.The t_max, C_max and AUC of 0 ~ (P> 0.05) .Conclusion: The bioavailability of the two formulations is bioequivalent when administered at 600mg. The relative bioavailability of A with single dose of B is (97.37 ± 9.98 )%.