兰索拉唑片相对生物利用度与生物等效性研究  

Study on the Relative Bioavailability and Bioequivalence of Lansoprazole Table

作　　者：李茜[1] 邓俊刚[1] 乔建[1] 黎维勇[1] 

机构地区：[1]华中科技大学同济医学院附属协和医院药剂科,武汉430022

出　　处：《医药导报》2009年第2期165-167,共3页Herald of Medicine

摘　　要：目的研究兰索拉唑胶囊与兰索拉唑片的人体相对利用度和生物等效性。方法健康志愿者19例，随机交叉单剂量口服试验制剂兰索拉唑片与参比制剂兰索拉唑胶囊，剂量均为30mg，洗脱期1周。分别于服药后12h内多点抽取静脉血；高效液相色谱法测定血浆兰索拉唑浓度。应用DAS2．0统计软件计算相对生物利用度并评价两种制剂生物等效性。结果单剂量口服试验制剂和参比制剂后血浆中兰索拉唑Cmax分别为（662．14±360．85）和（649．85±356．29）μg·L^-1；tmax分别为（2．82±0．53）和（2．26±0．63）h；AUC0→12分别为（1788．12±1078．25）和（1857．72±1136．34）μg·h·L^-1；AUC0→∞分别为（1892．97±1108．87）和（1938．03±1160．68）μg·h·L^-1。Cmax、AUC0→12和AUC0→∞90％可信区间分别为97．8％-104．8％，90．0％～101．9％和92．0％-103．2％。试验制剂与参比制剂的人体相对生物利用度为（96．8±15．1）％。结论试验制剂与参比制剂具有生物等效性。Objective To study the relative bioavailability and bioequivalenee of lansoprazole tablets and lansoprazole capsules in human plasma. Methods 19 healthy volunteers in randomized crossover study were given a single oral dose of 30 mg of the test or of the reference. 12 h later,blood was taken out at several time points. The plasma level of lansoprazole was determined by HPLC. The pharmaeokinetie parameters were calculated and the bioavailability and bioequivalence of two formulations were evaluated by DAS2. 0 program. Results Cmax of the test formulation and the reference one were , （662.14 ± 360.85 ） and （649.85 ± 356.29 ）μg· L^-1 ; tmax were （2. 82± 0. 53 ） and （ 2.26 ±0.63 ） h ; AUC0→12 were （1 788.12±1 078.25） and （1 857.72 ±1 136.34） μg · h · L^-1; AUC0→8, （1 892.97±1 108.87） and （1 938.03± 1 160.68） μg · h · L^-1 , respectively. The 90% confidential interval of Cmax, AUC0→12 and AUC0→∞ of the test were 97.8% 104.8% , 90.0%- 101.9% and 92.0% - 103.2% , respectively. The relative bioavailability was （96.8 ± 15.1 ） % for the test and reference preparation. Conclusion The two formulations are bioequivalent.

关 键 词：兰索拉唑 药动学 生物利用度 相对 生物等效性 色谱法 高效液相 

分 类 号：R965[医药卫生—药理学]