氢溴酸加兰他敏胶囊单次给药在健康人体内的药物动力学  

Pharmacokinetics of Galanthamine hydrobromine capsules in healthy Chinese volunteers

作　　者：刘梅[1] 张琰[1] 文爱东[2] 杨林[2] 李微[2] 袁静[2] 高晓华[2] 

机构地区：[1]第四军医大学唐都医院药学部,陕西西安710038 [2]第四军医大学西京医院药学部,陕西西安710032

出　　处：《华西药学杂志》2007年第4期410-412,共3页West China Journal of Pharmaceutical Sciences

摘　　要：目的研究单剂量口服氢溴酸加兰他敏胶囊后加兰他敏在健康人体内的药物动力学。方法24名健康受试者口服7.8 mg氢溴酸加兰他敏胶囊后,采用LC-MS法测定药后血浆中不同时间的加兰他敏浓度,计算主要药物动力学参数。结果药动学参数tmax、Cmax、t1/2、AUC0-t、AUC0-∞分别为0.76±0.28 h,55.4±13.2 ng.ml-1、7.1±2.0 h、434.8±106.2 ng.h.ml-1、457.8±109.5 ng.h.ml-1。结论加兰他敏口服吸收较快,耐受性与安全性均良好。OBJECTIVE To study pharmacokinetics of Galanthamine hydrobromine capsules after a single oral dose administration in healthy volunteers. METHODS A single oral 7.8 mg of Galanthamine was given to 24 healthy Chinese male volunteers. The plasma concentration of galanthamine from the volunteers at the certain timepoints after the administration was determined by LC - MS assay. RESULTS The main pharmacokinetic parameters of galanthamine oral preparation were as follows ： tmax was 0. 76 ± 0. 28 h, Cmax was 55.4 ± 13.2 ng·ml^-1 , t1/2 was 7. 1 ±2. 0 h, AUC0-∞ was 434. 8 ± 106. 2 ng · h·ml^-1 and AUC0-∞ was 457.8 ± 109. 5 ng· h·ml^-1 , respectively. CONCLUSION There are no serious adverse events or premature withdrawals from the study. Galanthamine is well tolerated and appeared to be safe in these Chinese voluteers.

关 键 词：加兰他敏 药物动力学 体内过程分析 液相色谱-质谱联用法 

分 类 号：R969.1[医药卫生—药理学]