摘要
目的研究氟康唑胶囊(抗真菌药)在健康人体的药代动力学和相对生物利用度。方法用两制剂双周期自身对照交叉试验设计,20名健康志愿者单次口服氟康唑150mg,用内标法定量,高效液相色谱法测定其血药浓度,用DAS1.0程序计算药代动力学参数。结果参比和受试制剂中氟康唑AUC0→t分别为(118±23)和(119±26)mg·h·L-1,AUC0→∞分别为(134±30),(131±33)mg·h·L-1;Cmax分别为(2.70±0.55)和(2.82±0.64)mg·h·L-1;tmax分别为(2.50±2.13),(2.35±1.16)h;相对生物利用度以AUC0→t与AUC0→∞计算,分别为(101.8±19.8)%,(99.7±24.3)%。结论2种制剂有生物等效性。
Objective To study the pharmacokinetics and bioavailability of two formulations of fluconazol capsules in healthy volunteers. Methods A single oral dose of 150 mg of fluconazol capsule was given to 20 healthy volunteers in an open randomized cross -over study. Plasma levels of fluconazol were determined by HPLC method. The pharmacokinetic parameters were calculated by DAS 1.0. Results The pharmacokinetic parameters for fluconazol were as follows： AUC0→t, were （118 ±23 ） and （119±26） mg · h · L^-1; AUC0→∞ were （134 ±30） and （131± 33） mg · h · L^-l; Cmax were （2.70±0.55） and （2.82±0.64） mg·h · L^-1 ; tmax were （2.50 ± 2.13 ） and （2.35 ± 1.16） h for reference and test fluconazol capsules, respectively. The relative bioavailability F0→t and F0-∞. were （ 101.8 ± 19.8 ） %, （ 99.7 ± 24.3 ） %, respectively. Conclusion The results of statistics analysis shown that the test and reference formulations were bioequivalence.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2006年第6期429-431,共3页
The Chinese Journal of Clinical Pharmacology
