盐酸文拉法辛胶囊的人体生物等效性  

Bioequivalence of two venlafaxine hydrochloride capsules in healthy volunteers

作　　者：姜云平[1] 于波涛[1] 张勤[1] 高朝霞[1] 徐光[1] 

机构地区：[1]成都军区总医院药剂科,四川成都610083

出　　处：《西南国防医药》2009年第11期1081-1083,共3页Medical Journal of National Defending Forces in Southwest China

摘　　要：目的：对盐酸文拉法辛两种胶囊制剂进行生物等效性评价。方法：18名健康受试者分别随机交叉单剂量口服盐酸文拉法辛胶囊50mg后，采用反相高效液相色谱．荧光检测法测定血药浓度。结果：受试制剂和参比制剂的药动学参数Cmax分别为（161．76±70．15）和（143．22±70．14）ng／ml；Tmax分别为（3．00±0．84）和（2．58±0．86）h；AUC0→t。分别为（917．17±500．72）和（834．48±437．99）ng／（h·ml）；AUC0→∞分别为（1115．46±687．85）和（1239．67±861．78）ng／（h·ml）；t1／2分别为（4．51±1．93）和（5．42±3．55）h。受试制剂AUC0→t的90％可信限落在参比制剂80．0％-125．0％范围内。Cmax的90％可信限落在参比制剂70．0％～143．0％范围内，Tmax经Witeoxon非参数秩和检验无显著性差异。结论：受试制剂与参比制剂在人体内生物等效。Objective： To evaluate the bioequivalence of two venlafaxine hydrochloride capsules. Methods ： Single oral dose of two venlafaxine hydrochl±oride capsules was given to 18 volunteers in an open randomized crossover way to study their pharmacokinetics and relative bioavailability. The venlafaxine concentrations in plasma were determined by reversed phase high performance liquid chromatography. Results： The pharmacokinetic parameters of test and control preparations were as follows： Cmax was（ 161.76 ± 70.15 ） vs. （ 143.22 ± 70.14 ） ng/ml; Tmax was （3.00 ±0.84）vs. （2.58 ±0.86） h;AUC0→t was（917.17 ± 500.72） vs. （834.48 ±437.99） ng/（h· ml） ;AUC0→∞ was（ 1115.46 ±687.85） vs, （ 1239.67 ± 861.78 ）ng/ （ h· ml） ;h/2 was （4.51 ± 1.93 ） vs. （5.42 ± 3.55 ） h. 90% confidence interval of AUC0→t and C max of test preparation ranged from 80.0% to 125.0% and control preparation did from 70.0% to 143.0%, respectively. The relative bioavailability of test preparation was （108.0 ± 27.4 ）%. Statistical analysis on Tmax showed that there was no significant difference between these two capsules. Conclusion：Test and control preparation were bioequivalent in human body.

关 键 词：文拉法辛 生物等效性 血药浓度 

分 类 号：R969[医药卫生—药理学]