格列吡嗪胶囊剂的相对生物利用度和生物等效性评价  

Relative bioavailability and bioequivalence of glipizide capsules

作　　者：黄圣凯[1] 杨劲[1] 黄开军 

机构地区：[1]中国药科大学

出　　处：《新药与临床》1995年第3期139-141,共3页

摘　　要：９名健康志愿者，随机交叉口服进口和国产格列吡嗪制剂，利用ＨＰＬＣ测定血浆中药物的达峰浓度Ｃｍａｘ分别为５９１±１７８ｎｇ·Ｌ－１和５２６±１８８ｎｇ·Ｌ－１，２种制剂的消除半衰期　分别为３．２±０．５和３．５±０．８ｈ，血药一时曲线下面积分别为４９１５±１４３２和４８１２±１３０９ｎｇ·ｈ·Ｌ－１。药一时曲线符合一级吸收的单房室模型，国产格列吡嗪片的相对生物利用度Ｆ为０．９８，表明２种制剂具有生物等效性。The bioavailability and bioequivalence of glipizide were investigated in a cross-over trial in 9 healthy volunteers after oral administration of two kinds of the capsules,imported(A)and domestic(B).One compartment model was fitted to the concentration-time profiles.The main pharmacokinetic parametes for the reference product A and test B showed Cmax 591±178 and 526±188 ng·L-1;3.2± 0.5 and 3.5±0.8 h;AUC 4915±1432 and 4812±1309 ng·h·L-1 respectively.Data of AUC from comparative bioavailability trial were analyzed by ANOVA and two one-sided test procedures.

关 键 词：降血糖药 格列吡嗪 生物学效用 药代动力学 

分 类 号：R977.15[医药卫生—药品]