摘要
目的 :测定替硝唑片在人体内的相对生物利用度。方法 :采用自身双周期交叉试验设计 ,单剂量服用重庆、广东两药厂生产的替硝唑片后 ,用高效液相色谱法测定血清中替硝唑浓度。结果 :两种替硝唑片的体内药时数据符合药动学一室模型 ,两厂替硝唑片消除速率常数t1/ 2 ke分别为 15 94± 3 0 8h-1和 16 15± 2 18h-1;Cmax为 12 86± 1 97μg·ml-1和 13 2 3± 2 2 6μg·ml-1;Tmax为 1 83± 0 77h和 1 75± 0 93h ;AUC0～ 72 为 2 86 75± 5 6 79mg·h·L-1和2 90 77± 64 79mg·h·L-1;相对生物利用度为 98 61%。结论
OBJECTIVE:To study relative bioavailability of Tinidazole tablets in normal volunteers.METHODS:500 mg single oral of Huabang tinidazole tablets and Bidi tinidazole tablets were given to 18 healthy volunteers in an open randomized cross over study.Tinidazole concentration in serum were determined by HPLC.The pharmacokinetic parameters as well as relative bioavailability were measured.RESULTS:The concentration time curves of two tinidazole tablets were conformed to one compartment open model. AUC (0-72) were 286.75±56.79 mg·h·L -1 and 290.77±64.79 mg·h·L -1 ,T max were 1 83±0 77 h and 1.75±0.93 h,C max were 12 86±1 97 μg·ml -1 and 13.23±2 26 μg·ml -1 ,respectively.There was no significant difference between the two formulations in the AUC (0 72) ,T max ,C max CONCLUSION:The relative bioavailability of Huabang tinidazole tablets was 98 61%,compared with Bidi tinidazole tablets.The results of the statistical analysis showed that the two tablets were bioequivalent.
出处
《华西药学杂志》
CAS
CSCD
2001年第4期281-282,共2页
West China Journal of Pharmaceutical Sciences
