摘要
目的 研究氟康唑胶囊对健康人体的药动学和相对生物利用度。方法 采用高效液相色谱法 (HPLC) ,测定 2 0名男性健康受试者单剂量交叉口服 30 0mg两种氟康唑胶囊后 ,不同时间血浆中的药物浓度。结果 两制剂的药时曲线均符合一房室模型 ,被试制剂和参比制剂的主要药动学参数如下 :Cmax分别为 (6 .2 2± 0 .6 9)mg·L-1和(6 .2 6± 0 .6 2 )mg·L-1;Tmax分别为 (1.78± 0 .93)h和 (1.78± 0 .75 )h ;T1/2ke分别 (2 5 .99± 4 .81)h和 (2 6 .2 0± 3.13)h ;AUCt0 分别为 (2 0 2 .2 2± 37.37)mg·h·L-1和 (2 0 9.98± 34.4 1)mg·h·L-1;AUC∞0 分别为 (2 2 1.77± 5 0 .71)mg·h·L-1和(2 2 6 .73± 37.78)mg·h·L-1;对试制剂的相对利用度F10 与F∞0 分别为 (97.74± 17.39) %和 (98.4 2± 19.4 6 ) %。结论 方差分析和双单侧t检验证明
Objective To study pharmacokinetics and bioavailability of fluconazole in 20 young healthy volunteers.Methods The fluconazole concentrations in plasma were determined by HPLC after a single oral dose of standard formulation and the tested formulation was respectively given to 20 volunteers in randomized cross-over test.Results The concentration-time curves of the two formulations fitted to a one-compartment open model.The C max was (6.22±0.69)mg·L -1 and(6.26±0.62)mg·L -1,T max was(1.78±0.93)h and (1.78±0.75)h;T 1/2ke was (25.99±4.81)h and (26.205±3.13)h;AUC t 0 was (202.22±37.37)mg·h·L -1 and (209.98±34.41) mg·h·L -1,AUC ∞ 0 was (221.77±50.71) mg·h·L -1 and (226.73±37.78) mg·h·L -1,respectively.The pharmacokinetic parameters obtained form the study showed no significant difference between the two formulations(P>0.05).The relative bioavailability was (97.74±17.39)% and (98.42±19.46.03)% of tested formulation.Conclusion The results of statistical analysis prove that the two formulations are bioequivalent.
出处
《河南职工医学院学报》
2004年第2期103-105,共3页
Journal of Henan Medical College For Staff and Workers
