中国药房2011，Vol.22Issue(18)：1669-1672,4.
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
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
作者信息
- 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
- 折叠
摘要
Abstract
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
医药卫生引用本文复制引用
华卡,李健和,朱运贵,易利丹,曹俊华,刘晓磊,阳巧凤,曾小慧,罗霞..盐酸甲氯芬酯胶囊在健康人体内的生物等效性研究[J].中国药房,2011,22(18):1669-1672,4.
