益智药阿尼西坦胶囊在人体内的生物等效性评价  

Evaluation of the biological equivalence of aniracetam capsules in human body

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

机构地区：[1]解放军第四军医大学西京医院药剂科,陕西省西安市710023

出　　处：《中国临床康复》2004年第4期660-661,共2页Chinese Journal of Clinical Rehabilitation

摘　　要：目的:比较两种阿尼西坦胶囊在健康志愿者体内的药动学及生物等效性。方法:18名男性健康志愿受试者,采用标准二阶段交叉设计自身对照试验方法,单剂量口服阿尼西坦胶囊试验品和参比品400mg,以高效液相色谱法测定血浆中阿尼西坦主要活性代谢产物—对甲氧基苯甲酰氨基丁酸(N-anisoyl-GABA,ABA)的经时浓度,对两种阿尼西坦胶囊制剂的主要参数进行统计学比较。结果:两种阿尼西坦胶囊在健康志愿者体内的药-时曲线均符合一级吸收的单室模型,试验品和参比品的主要药动学参数达峰时间Tmax(实测值)、最大血药浓度Cmax(实测值)、曲线下面积AUC0～180min分别为:(28.90±3.23)比(30.00±6.60)min,(11.33±2.49)比(10.64±2.09)mg/L,(801.62±151.88)比(750.21±147.78)mg·min/L(F=0.1607～3.4532,P均>0.05);试验品的相对生物利用度为108.4%。结论:统计学结果显示两种阿尼西坦胶囊制剂具有生物等效性。AIM:To compare the pharmacokinetic parameters and bioavailability of two kind s of aniracetam capsules inside the healthy volunteers. METHODS:A standard two-period crossover self control trial was conducted to eighteen healthy male volunteers.Concentration of N-anisoyl-GABA ABA,the ma in active metabolite of aniracetam capsules in plasma were assayed by high perfo rmance liquid chromatograpy(HPLC) after a single dosage oral 400 mg that were fo r test or reference.The main pharmacokinetics parameters(AUC,Cmax and Tmax)were analyzed by statistical methods. RESULTS:The concentration-time curve after medication conformed to a 1-co mpartment open model with a first order absorption.Tmax,Cmax and AUC(0-180 min ) of tested and referenced were(28.90± 3.20) to(30.00± 6.60)min, (11.33± 2.4 9) to (10.64± 2.09) mg/L, (801.62± 151.88) to(750.21± 147.78) mg· min/L res pectively(F=0.1607-3.4532,P >0.05).The relative bioavalability of tested was 1 08.4% . CONCLUSION:The statistical results show that the two aniracetam capsules are of biological equivalence.

关 键 词：益智药 何尼西坦胶囊 生物等效性 药动学 治疗 

分 类 号：R969[医药卫生—药理学]