盐酸甲氯芬酯胶囊在健康人体内的生物等效性研究  

Bioequivalence Study of Meclofenoxate Hydrochloride Capsule in Healthy Volunteers

作　　者：华卡[1] 李健和[2] 朱运贵[2] 易利丹[2] 曹俊华[3] 刘晓磊[2] 阳巧凤[2] 曾小慧[2] 罗霞[2] 

机构地区：[1]湖南省脑科医院药剂科,长沙市410007 [2]中南大学湘雅二医院药学部,长沙市410011 [3]湖南省马王堆医院,长沙市410016

出　　处：《中国药房》2011年第18期1669-1672,共4页China Pharmacy

摘　　要：目的:研究2种盐酸甲氯芬酯胶囊在中国健康志愿者体内的生物等效性。方法:18名健康男性志愿者随机分为2组,分别单剂量交叉口服盐酸甲氯芬酯胶囊受试制剂或参比制剂200mg。于服药前0h和服药后0.33、0.67、1、1.5、2、2.5、3、4、6、8、10、14、24h时抽取静脉血,采用高效液相色谱法测定血浆中对氯苯氧乙酸的浓度。通过DASVer2.0软件计算主要药动学参数,评价2制剂的生物等效性。结果:盐酸甲氯芬酯受试制剂与参比制剂的药动学参数分别为:tma(x2.11±0.37)、(2.06±0.34)h,cmax(12.56±2.85)、(12.78±2.84)μg·mL-1,t1/(25.81±2.68)、(6.00±2.14)h,AUC0～2(434.11±7.89)、(34.12±7.99)μg·h·mL-1,AUC0～∞(34.83±7.68)、(34.79±7.97)μg·h·mL-1。以AUC0～24计算,受试制剂对参比制剂的相对生物利用度为(100.7±11.7)%。结论:2种盐酸甲氯芬酯胶囊在中国健康志愿者体内具有生物等效性。OBJECTIVE：To evaluate the bioequivalence of two kinds of Meclofenoxate hydrochloride capsule in Chinese healthy volunteers.METHODS：18 healthy male volunteers were randomly divided into 2 groups and given single oral dose of meclofenoxate test preparation or reference preparation 200 mg.The blood samples were collected at 0 h,and 0.33,0.67,1,1.5,2,2.5,3,4,6,8,10,14,24 h after adiministrotion.The concentration of chlorophenoxyacetic acid in plasma was determined by HPLC.The pharmacokinetic parameters were calculated and the relative bioequivalence was evaluated by DAS Ver 2.0 software.RESULTS：The main pharmacokinetic parameters of trial capsules vs.reference capsule of meclofenoxate hydrochloride were as follows：tmax（2.11±0.37）h vs.（2.06±0.34）h;cmax（12.56±2.85）μg·mL-1 vs.（12.78±2.84）μg·mL-1,t1/2（5.81±2.68）h vs.（6.00±2.14） h;AUC0～24（34.11±7.89）μg·h·mL-1 vs.（34.12±7.99）μg·h·mL-1;AUC0～∞（34.83±7.68）μg·h·mL-1 vs.（34.79±7.97）μg·h·mL-1,respectively。The relative bioavailability of test capsule was（100.7±11.7）%.CONCLUSION：Two kinds of meclofenoxate hydrochloride capsules are bioequivalent in Chinese healthy volunteers.

关 键 词：盐酸甲氯芬酯胶囊 对氯苯氧乙酸 高相液相色谱法 生物等效性 

分 类 号：R969.1[医药卫生—药理学] R971.7[医药卫生—药学]