甲钴胺片人体药代动力学和生物等效性  

Pharmacokinetics and relative bioequivalence of mecobalamin tablets in healthy volunteers

作　　者：林琳[1] 文爱东[1] 赵磊[1] 王萌[1] 吴寅[1] 张三奇[1] 

机构地区：[1]第四军医大学西京医院药剂科,陕西西安710033

出　　处：《第四军医大学学报》2004年第5期471-474,共4页Journal of the Fourth Military Medical University

摘　　要：目的 :比较国产和进口甲钴胺片在人体内的药物代谢动力学和相对生物等效性 ,确保临床用药质量 .方法 :2 4例男性健康受试者采用标准二阶段自身交叉对照试验法服用药物 ,以微粒子捕捉酶免法测定受试者服药后 72h内血清中甲钴胺经时浓度 ,计算甲钴胺的药动学参数并将数据进行统计学处理 .结果 :国产和进口甲钴胺的主要药动学参数 :达峰时间Tmax实测值分别为 (3.0± 0 .9)h和 (3.1± 0 .9)h ,峰值血清浓度Cmax实测值分别为 (2 86± 1 0 1 )ng/L和 (2 70± 98)ng/L ,药时曲线下面积AUC(0 -72h) 分别为 (5 30 6± 1 80 1 )ng/ (h·L) 和 (5 4 0 8± 1 82 8)ng/ (h·L) ,两种甲钴胺片各主要药动学参数间均无统计学差异 (P >0 .0 5 ) ,国产对进口甲钴胺片的相对生物利用度为 99.2 % .结论 :两种制剂在人体内具有生物等效性 .AIM: To ensure the quality of the medicine by comparing the pharmacokinetic parameters and the relative bioavailability of China made and imported mecobalamin tablets. METHODS: An open, randomized, two period crossover study with a two week washout interval was conducted in 24 healthy volunteers. Concentrations of mecobalamin in serum were assayed by MEIA method and the main pharmacokinetics parameters (AUC, Cmax and Tmax) were analyzed by two one sided t test. RESULTS: The AUC (0-72 h), Cmax and Tmax of tramadol were (5306± 1801) ng/(h·L) and (5408±1828) ng/(h·L),(286±101) ng/L and (270±98) ng/L,(3.0±0.9)h and(3.1±0.9)h, respectively. CONCLUSION: As the relative bioavailability of China made and imported mecobalamin tablets are 99.2%, China made and imported mecobalamin tablets are bioequivalent.

关 键 词：甲钴胺 微粒子捕捉酶免法 药代动力学 生物等效性 

分 类 号：R969.1[医药卫生—药理学]