格列齐特缓释片在健康人高脂饮食后的药动学及生物等效性  

Pharmacokinetics and Bioequivalence of Gliclazide Sustained-release Tablets in Healthy Volunteers after High Fat Diet

作　　者：杨丽君[1] 朱运贵[1] 

机构地区：[1]中南大学湘雅二医院临床药学研究室,湖南长沙410011

出　　处：《中国医药工业杂志》2009年第9期684-687,共4页Chinese Journal of Pharmaceuticals

摘　　要：研究了格列齐特缓释片在健康人高脂饮食后的药动学和生物等效性。以进口胶囊为参比制剂,国产胶囊为受试制剂,18名健康受试者高脂饮食后随机交叉口服受试制剂和参比制剂60 mg。以格列吡嗪为内标,采用HPLC-UV法测定血药浓度。结果显示:高脂饮食后受试制剂和参比制剂的主要药动学参数为:c_(max)(2.457±0.376)和(2.443±0.310)mg/L,AUC_(0-(?))(40.782±7.653)和(39.341±5.389)mg·h·L^(-1),AUC_(0-∞)(42.456±7.029)和(42.913±8.154)mg·h·L^(-1),t_(max)(5.39±0.85)和(5.50±0.71)h。受试制剂的相对生物利用度为(103.3±8.4)%,两制剂具有生物等效性。The pharmacokinetics and bioequivalence of gliclazide sustained-release tablets in healthy volunteers after high fat diet were discussed. The domestic and imported tablets were used as test and reference preparation. According a randomized two-period crossover design, a single oral dose of 60 mg gliclazide sustained-release tablets was given to 18 healthy volunteers after high fat diet. The plasma concentrations of gliclazide were determined by HPLC- UV, with glipizide as the internal standard. The main pharmacokinetic parameters for test and reference preparation were as follows： Cmax, （2.457±0.376） and （2.443±0.310） mg/L, AUC0-t （40.782±7.653） and （39.341±5.389） mg·h·L^-1, AUCo.= （42.456±7.029） and （42.913±8.154） mg·h·L^-1, tmax （5.39±0.85） and （5.50±0.71） h, respectively. The relative bioavailability of the test preparation was （103.3±8.4） %. The results showed that the test and reference preparation were bioequivalent.

关 键 词：格列齐特 高脂饮食 高效液相色谱 药动学 生物等效性 

分 类 号：R969[医药卫生—药理学]