论文部分内容阅读
目的:在8名健康志愿者体内研究了国产盐酸特拉唑嗪胶囊和进口片剂的药物动力学和生物利用度。方法:受试者交叉口服单剂量(2mg)盐酸特拉唑嗪胶囊和片剂后,采用高效液相色谱法和荧光检测器测定血药浓度。结果:胶囊和片剂的药时曲线均符合二室模型,其Tmax分别为1.3±0.6h和1.3±0.4h,Cmax分别为49.5±8.6ng·ml-1和50.3±5.2ng·ml-1,AUC0→∞分别为536.5±39.8ng·ml-1和586.6±52.8ng·ml-1·h,测试药品的相对生物利用度为92.30%±12.91%。结论:经方差分析两药药物动力学参数间差异均无显著性(P>0.05);结果表明两药具有生物等效性。
OBJECTIVE: To study the pharmacokinetics and bioavailability of domestic terazosin hydrochloride capsules and imported tablets in 8 healthy volunteers. METHODS: Subjects crossed over with a single dose (2 mg) of terazosin hydrochloride capsules and tablets at the crossing of the subjects. The plasma concentration was determined by HPLC and fluorescence detector. Results: The time curves of capsules and tablets were in accordance with the two-compartment model with Tmax of 1.3 ± 0.6 h and 1.3 ± 0.4 h respectively, with Cmax of 49.5 ± 8.6 ng · ml -1 And 50.3 ± 5.2 ng · ml-1, respectively. The AUC0 → ∞ were 536.5 ± 39.8 ng · ml-1 and 586.6 ± 52.8 ng · ml-1 · h, respectively. The relative bioavailability of the tested drugs The degree is 92.30% ± 12.91%. Conclusion: There is no significant difference between the two pharmacokinetic parameters by ANOVA (P> 0.05). The results show that the two drugs have bioequivalence.