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10名男性健康志愿受试者单剂量交叉口服10mg富马酸比索洛尔胶囊和富马酸比索洛片,用高效液相色谱荧光检测法测定血浆富马酸比索洛尔浓度,进行富马酸比索洛尔胶囊的药代动力学和相对生物利用度研究.结果表明:富马酸比索洛尔胶囊和片剂的血药浓度时间曲线图均符合口服吸收二室模型,主要药动学参数T_ρ口分别为1.05±1.89h和2.20±l.75h,C_mAX分别为63.27±16.05υg·L~-1和57.49±10.49υg·L~-1/,t_1/2β分别12.79±2.86h和13.11±3.93h,AUC分别为788.50±105.02υg·L~-1和759.22±111.56υg·L~-1.两种剂型的药代动力学参数经统计学分析无明显性差异(P>0.05).富马酸比索洛尔胶囊的相对生物利用度为100.1±18.7%,结果提示受试的胶囊剂和对照的片剂生物等效.
Ten male healthy volunteers were given a single dose of 10 mg bisoprolol fumarate capsules and bisoprolol fumarate tablets. The plasma concentration of bisoprolol fumarate was determined by high performance liquid chromatography with fluorescence detection, The pharmacokinetics and relative bioavailability of bisoprolol capsules were studied.The results showed that the plasma concentration time curves of bisoprolol fumarate capsules and tablets were in accordance with the two-compartment model of oral absorption, and the main pharmacokinetic parameters T ρ Respectively, 1.05 ± 1.89h and 2.20 ± l.75h respectively, C_mAX were 63.27 ± 16.05υg · L ~ -1 and 57.49 ± 10.49υg · L ~ -1 / respectively, and t_1 / 2β were 12.79 ± 2.86h and 13.11 ± 3.93 h and AUC were 788.50 ± 105.02 υg · L ~ -1 and 759.22 ± 111.56 υg · L ~ (-1) respectively.The pharmacokinetic parameters of the two formulations had no statistical difference (P> 0.05) The relative bioavailability of acid bisoprolol capsules was 100.1 ± 18.7%, suggesting that the capsules tested were bioequivalent to the control tablets.