摘要
目的研究抑平舒 (国产 )与西那普利药动学及生物等效性。 方法 14名志愿者分别单剂量口服2 .5mg抑平舒与西那普利 ,采用以14 C -HHL为ACE底物的放射酶分析法测定血药对ACE的抑制率及两者的药动学参数 ,并以AUC0→∞ 与Cmax/AUC0→∞ 为指标 ,用t检验法分析两种制剂的生物等效性。 结果两者的药 -时曲线可用二室模型拟合 ,两者的Cmax(ng·ml 1)分别为 82 .4与 83.5 ;tmax(h)分别为 2 .3与 2 .3;AUC0→∞(ng·ml 1·h)分别为175 9.0与 2 16 2 .9;Imax(% )分别为 97.11与 97.49。两者AUC0→∞ 与Cmax/AUC0→∞ 无显著性差异 (P >0 .0 5 )。结论抑平舒与西那普利为生物等效制剂 ,抑平舒的相对生物利用度为 81.3%。
Objective To study the pharmacokinetics and relative bioavailability between Yi pingshu (cilazapril tablet manufactured by Roche,Shanghai)and cilazapril produced by Roche,Switzerland. Methods The concentrations in plasma isolated from 14 volunteers who accepted 2.5mg of oral dose of Yipingshu and cilazapril respectively in an open randomized cross-over test was determined by the radioenzymatic method. Results The concentration-time curves of Yipingshu and cilazapril were confirmed to an other apartment open model with a second order absorption.The C max (ng·ml 1 )of Yipignshu and cilazapril tablet were 82.4 and 83.5,t max (h)were 2.3 and 2.3,AUC 0-∞ (ng·ml 1 ·h)were 1759.0 and 2162.9,I max % were 97.11 and 97.49,respectively.The results showed that there was no significant difference between the parameters described above (P>0.05)。 Conclusion The formulation of Yipinshu and cilazapril is equivalent.The ralative bioavalability of Yipingshu is 81.3%.
出处
《上海第二医科大学学报》
CSCD
2001年第1期17-19,共3页
Acta Universitatis Medicinalis Secondae Shanghai
基金
上海市科委课题!( 99HX0 0 6)
