摘要
目的 :研究头孢呋辛酯片在健康人体内的药物动力学和相对生物利用度。方法 :按标准的 2× 2交叉试验方案设计 ,2 2名健康男性志愿者分别予参比制剂及受试制剂各 5 0 0 mg,po,血清中药物浓度采用 RP- HPL C法检测。结果 :参比制剂及受试制剂口服后体内药物动力学过程符合一室模型 ,tmax分别为 ( 2 .0 4 5± 0 .72 2 )和 ( 2 .0 4 5± 0 .63 5 ) h,cmax分别为 ( 5 .894± 1.5 10 )和( 6.5 5 6± 1.5 2 5 )︼g/ ml,AU C( 0 - T) 分别为 ( 18.92 7± 5 .5 82 )和 ( 19.63 8± 4 .70 0 )︼g· h/ m l,AU C( 0 -∞ ) 分别为 ( 19.5 95± 5 .897)和( 2 0 .0 2 3± 4 .85 3 ) ︼g· h/ ml,T1 / 2 分别为 ( 1.3 17± 0 .5 5 1)和 ( 1.119± 0 .191) h,Ke分别为 ( 0 .5 64± 0 .14 2 )和 ( 0 .645± 0 .15 3 )h- 1 ,Ka分别为 ( 1.0 0 4± 0 .4 5 1)和 ( 1.0 0 4± 0 .3 15 ) h- 1 。受试制剂头孢呋辛酯片的相对生物利用度为 10 6.99%。结论
AIM: To study the pharmacokinetics and bioequivalence of cefuroxime axetil tablets in healthy volunteers. METHODS: A dose of 500 mg was given to 22 healthy male volunteers according to a randomized two way cross over design. A reverse phase high performance liquid chromatography (RP HPLC) method was established to determine the concentrations of cefuroxime in serum. RESULTS: The concentration time curves of 2 preparations were fitted to one compartment model. The peak time ( t max ) of reference and test drug were (2.045±0 722) and (2.045±0 635) h, the peak serum levels ( c max ) were (5.894±1 510) and (6.556±1.525) μg/ml, AUC (0 T) were (18.927±5 582) and (19.638±4.700) μg·h/ml, AUC (0 ∞) were (19 595±5 897) and (20 023±4 853) μg·h/ml, T 1/2 were (1.317±0 551) and (1.119±0 191) h, Ke were (0.564±0 142) and (0.645±0 153) h -1 , Ka were (1.004±0 451) and (1.004±0.315) h -1 , respectively. The relative bioavailability of the test drug was 106.99%. CONCLUSION: The 2 preparations are bioequivalent.
出处
《中国临床药学杂志》
CAS
2001年第6期376-378,共3页
Chinese Journal of Clinical Pharmacy
