摘要
目的研究替硝唑片在健康人体的药代动力学和相对生物利用度。方法采用高效液相色谱法测定20名健康男性志愿者,随机交叉单剂量口服替硝唑片1g后血浆中的药物浓度,计算药代动力学参数和相对生物利用度,并进行生物等效性评价。结果受试和参比替硝唑片的t1/2分别为(13.98±1.55)h、(13.80±0.93)h,tmax分别为(2.1±1.0)h、(2.3±0.9)h,cmax分别为(18.60±2.27)mg·L-1、(18.47±3.14)mg·L-1,AUC0τ分别为(368.49±44.08)mg·L-1·h-1、(353.86±40.99)mg·L-1·h-1。受试制剂于参比制剂的人体相对生物利用度为104.9±13.4%。结论两种制剂的药代动力学参数相近,具有生物等效性。
AIM To study the pharmakineties and relative bioavailability of tinidazole tablets. METHODS The serum concentration of 20 volunteers were determined by HPLC after a random cross single oral dose of 1 g of tinidazole tablets, the phannakinetics and relative bioavailability were calculated and the biequivalence was evaluated as wen. RESULTS For the test and the reference tablets, the tl/2 of which were （ 13.98 ± 1.55） h and （ 13.80 ± 0.93） h respectively, the tmax of which were （2.1 ± 1.0） h and （ 2.3 ± 0.9 ） h respectively, the cmax, of which were （ 18.60 ± 2.27）mg·L^-1 and （ 18.47 ± 3.14）mg·L^-1 respectively, the AUC0-τ of which were （368.49 ± 44.08） mg·L^-1·h^-1 and （353.86± 40.99）mg·L^-1·h^-1 respectively, the relative bioavailability of the test preparation was （104.9 ± 13.4% ） of the reference one. CONCLUSION The test and the reference tablets were of bioequivalence.
出处
《江苏药学与临床研究》
2006年第2期117-119,共3页
Jiangsu Pharmacertical and Clinical Research
