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8名男性健康志愿者交叉口服2mg国产盐酸特拉唑嗪片和进口的盐酸特拉唑嗪片,进行了国产制剂生物利用度研究,血药浓度用HPLC法测定。结果表明:口服国产和进口两种制剂的血药浓度时间曲线均符合二室模型,Ka分别为2.27±1.31和2.24±1.46h-1;Ke分别为0.069±0.09和0.06±0.08h-1;Cmax分别为60.36±14.68和59.69±11.06μg/L,于1.03±0.38h达峰,T1/2分别为10.86±2.13和11.55±3.09h,AUC是505.8±69.24和488.14±86.77μg·L·h-1,比较两种制剂的药代动力学参数均无显著性差异(P>0.05)。国产盐酸特拉唑嗪片剂的相对生物利用度为104.49%,两种制剂生物等效。
Eight healthy volunteers were given oral crossover oral 2mg terazosin hydrochloride tablets and imported terazosin hydrochloride tablets, bioavailability of domestic formulations were studied, the plasma concentration was determined by HPLC. The results showed that the time curves of plasma concentrations of both domestic and imported preparations accorded with the two-compartment model with Ka values of 2.27 ± 1.31 and 2.24 ± 1.46 h-1, respectively. The Ke values were 0.069 ± 0.09 and 0.06 ± 0.08h-1 respectively; Cmax was 60.36 ± 14.68 and 59.69 ± 11.06μg / L respectively, reached the peak at 1.03 ± 0.38h, T1 / 2 Were 10.86 ± 2.13 and 11.55 ± 3.09 h, AUC was 505.8 ± 69.24 and 488.14 ± 86.77 μg · L · h-1, pharmacokinetics were compared between the two formulations There was no significant difference between the parameters (P> 0.05). The relative bioavailability of domestic-made terazosin tablets was 104.49%, and both formulations were bioequivalent.