【摘要】 目的 :比较试验制剂国产奥硝唑片及国产奥硝唑胶囊与参比制剂进口奥硝唑片的生物等效性。方法 :18名健康志愿者 ,单剂三交叉口服试验制剂奥硝唑片、奥硝唑胶囊和参比制剂 1.5 g ,于药前和药后0 .5 ,1,1.5 ,2 ,3,4 ,6 ,8,12 ,2 4 ,36 ,4 8,72h取肘静脉血 ,用高效液相色谱法测定奥硝唑经时血药浓度 ,数据经 3P97处理得药代动力学参数 ,根据试验制剂和参比制剂AUC计算相对生物利用度。同时对主要药代动力学参数进行方差分析、双单侧t检验和 (1- 2α)置信区间分析 ,评价试验制剂和参比制剂的生物等效性。结果 :试验制剂奥硝唑片、奥硝唑胶囊和参比制剂主要药代动力学参数t1/ 2 ( β) 分别为 (16 .2 9± 2 .199) ,(16 .0 8± 2 .317)和 (15 .84 9± 2 .2 6 4 ) ,tpeak分别为 (1.75± 0 .4 93) ,(1.75± 0 .4 93)和 (1.75± 0 .4 79)h ,Cmax分别为(2 1.5 34± 3.5 3) ,(2 1.936± 3.314 ) ,(2 0 .85± 5 .939) μg·ml-1,AUC0～ 72 分别为 (44 4 .5 6± 5 5 .872 ) ,(44 6 .4 98± 5 5 .138)、(433.30 9± 5 8.5 2 1) μg·ml-1·h-1,AUC0～∞ 分别为 (46 2 .94 9± 5 5 .35 4 ) ,(46 5 .2 2 1± 5 6 .73) ,(45 1.6 6 8± 5 7.971) μg·ml-1·h-1,奥硝唑片、奥硝唑胶囊相对生物利用度分别为 10 2 .91± 8.93%更多还原

【Abstract】 Objective: To study the bioequivalence of domestic ornidazole tablet/capsule in healthy volunteers. Methods: Eighteen volunteers were randomly divided into 3 groups(test 1,test 2 and reference ),6 in each,with three crossover design. Blood samples were collected at 0, 0.5,1, 1.5 ,2,3,4,6,8,12,24,36,48and 72 h after single oral dose of 1.5 g domestic ornidazole tablet/capsule and imported ornidazole tablet, respectively.The time-concentrations of ornidazole were determined by HPLC and pharmarcokinetic parameters were calculated with 3P97 practical pharmacokinetic programme. Results: The pharmarcokinetic parameters of domestic ornidazole tablet, capsule and imported ornidazole tablet were as follows: t _ 1/2(β) ( 16.29 ± 2.199 ), ( 16.08 ± 2.317 ) and ( 15.849 ± 2.264 ), t _ peak ( 1.75 ± 0.493 ),( 1.75 ± 0.493 ) and ( 1.75 ± 0.479 )h, C _ max ( 21.534 ± 3.53 ),( 21.936 ± 3.314 )μg/ml and ( 20.85 ± 5.939 )μg·ml, AUC _ 0～72 ( 444.56 ± 55.872 ),( 446.498 ± 55.138 ) and (433.309±58.521)μg/ml·h, AUC _ 0～∞ ( 462.949 ± 55.354 ),( 465.221 ± 56.731 ) and ( 451.668 ± 57.971 )μg·ml -1 ·h -1 . The relative bioavailability of ornidazole tablet was ( 103.52% ± 6.59% )and that of ornidazole capsule was ( 102.91% ± 8.93% ). Conclusion: The statistical analysis showed that the tests and reference were bioquivalent.更多还原