甲钴胺血清浓度的测定及生物等效性研究  

Determination of Mecobalamin in Serum and its Bioequivalence

作　　者：赵磊[1] 文爱东[1] 张三奇[1] 林琳[1] 王萌[1] 

机构地区：[1]中国人民解放军第四军医大学西京医院,药剂科陕西西安710032

出　　处：《解放军药学学报》2004年第5期355-357,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的　建立血清中甲钴胺的血药浓度测定方法 ,比较国产甲钴胺胶囊和进口甲钴胺片在健康人体内的相对生物等效性。方法　 2 4名男性健康志愿者以标准二阶段交叉设计自身对照试验法 ,分别口服单剂量二种甲钴胺制剂 ,采用微粒子酶免法测定受试者服药后 72h内血清中甲钴胺的浓度。结果　国产和进口甲钴胺主要的药代动力学参数 Tmax　分别为 3.15± 0 .95、3.10± 0 .88h ,Cmax　、AUC(0 -72h) 分别为 :310± 10 6、2 70± 98ng·L-1;5 5 88± 170 6、5 4 0 8± 182 8ng·h-1·L-1,药动学参数间均无统计学差异 (P >0 .0 5 ) ,国产胶囊对进口片剂的相对生物利用度为 10 5 .3%。结论　二种甲钴胺制剂在健康志愿者体内具有生物等效性。Aim To establish a microparticle enzyme immunoassay(MEIA) for determination of mecobalamin in serum and to compare the relative bioequivalence of domestic and imported mecobalamin.Methods A single oral dose of two kinds of mecobalamn were given to 24 healthy volunteers in a randomized two-period crossover study.The concentrations of mecobalamin in serum were determined by MELA method.Results The main pharmacokinetics parameters of domestic and imported mecobalamin(T max ,C max and AUC) were 3.15±0.95 and 3.10±0.88h,310±106 and 270±98ng·L -1,or 5 588±1 706 and 5 408±1 828ng·h -1·L -1 respectively.There were no statistic differences between tablet and capsule(P>0.05).The relative bioavailability of domestic mecobalamin capsule was 105.3%.Conclusion The two kinds of mecobalamin were bioequivalent in healthy volunteers.

关 键 词：甲钴胺 血清浓度 测定 生物等效性 药代动力学 微粒子酶免法 

分 类 号：R969.1[医药卫生—药理学]