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对10名健康男性受试者连续6d多剂量交叉poIS5MN缓释片和普通片的药代动力学性质和相对生物利用度进行了研究。结果表明:IS5MN缓释片和普通片的Tmax分别为50h和14h(P<005),前者的缓释效果十分明显;AUC经对数转换后的多种统计分析表明,IS5MN缓释片(40mg)与IS5MN普通片(20mg×2)生物等效;IS5MN缓释片的相对生物利用度为10895%;IS5MN缓释片和普通片的Cmin分别为7420ng·ml-1和13442ng·ml-1(P<005),而两种制剂的其他药代动力学参数如Cmax,AUC240,AUC∞0,Ke,T1/2以及波动系数(FI)等均无显著性差异(P<005)。多次给药后两种制剂都无明显的蓄积。
The pharmacokinetic properties and relative bioavailability of povidone-5MN sustained-release tablets and conventional tablets of 6 healthy multi-dose crossover patients were studied in 10 healthy male subjects. The results showed that the Tmax of IS5MN sustained-release tablets and ordinary tablets were 50h and 14h (P <005), respectively, the former sustained-release effect is very obvious; AUC after logarithmic conversion Statistical analysis showed that IS5MN sustained release tablets (40mg) and IS 5MN ordinary tablets (20mg × 2) bioequivalence; IS5MN sustained release tablets relative bioavailability of 108 95% ; Cmin of IS5MNmodified and conventional tablets were 7420ng · ml-1 and 13442ng · ml-1, respectively (P <005), while the other pharmacokinetic parameters Such as Cmax, AUC240, AUC ∞ 0, Ke, T1 / 2 and fluctuation coefficient (FI), etc. There was no significant difference (P <005). There was no significant accumulation of both preparations after multiple administrations.