盐酸曲马多缓释滴丸在比格犬体内的药动学

发布时间：2018-08-07 17:46

【摘要】：目的:研究盐酸曲马多(Tr)缓释滴丸在比格犬体内的药动学,评价其生物利用度。方法:6只Beagle犬雌雄各半,采用两制剂双周期随机交叉试验设计,分别单剂量口服Tr缓释滴丸和缓释片,用高效液相色谱-紫外(HPLC-UV)法测定曲马多的血药浓度。结果:Tr缓释滴丸和缓释片的Cmax分别为(273.34±69.2)ng·mL-1和(244.02±94.88)ng·mL-1,Tmax分别为(6.5±0.84)h和(6.0±0.89)h,AUC0-t分别为(2 893.87±811.40)ng·h·mL-1和(2 505.99±628.50)ng·h·mL-1,试验制剂与参比制剂相对生物利用度为97.2%±13.6%,经统计学处理,试验制剂AUC0-24的90%置信区间为96.4%~116.5%,Cmax的90%置信区间为103.1%~114.9%。结论:Tr缓释滴丸和缓释片在体内的处置均符合一室模型,单次给药给予相同剂量时二者具有生物等效性。
[Abstract]:Aim: to study the pharmacokinetics and bioavailability of tramadol (Tr) sustained-release dropping pills in Beagle dogs. Methods Twenty six Beagle dogs were divided into two groups: male and female. Tr sustained-release pills and sustained release tablets were administered orally. The plasma concentrations of tramadol were determined by high performance liquid chromatography-ultraviolet (HPLC-UV). Results the Cmax of the two tablets were (273.34 卤69.2) ng mL-1 and (244.02 卤94.88) ng mL ~ (-1) mL-1, respectively, and (6.5 卤0.84) h and (6.0 卤0.89) h AUC _ (0-t) were (2 893.87 卤811.40) ng h mL-1 and (2 505.99 卤628.50) ng h ml ~ (-1), respectively. The relative bioavailability of the test and reference tablets was 97.2% 卤13.6T, respectively. The 90% confidence interval of test preparation AUC0-24 was 96.4% and the 90% confidence interval of Cmax was 103.1% and 114.9%. Conclusion the results showed that the treatment of the two tablets in vivo was in accordance with the one-compartment model, and they were bioequivalent when given the same dose once.
【作者单位】：内蒙古科技大学包头医学院第二附属医院药剂科;北京正大绿洲医药科技有限公司;内蒙古医科大学药学院药剂教研室;哈尔滨商业大学药学院;
【基金】：内蒙古自治区自然科学基金项目(编号:20080404MS1206)
【分类号】：R965

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