医药导报2011，Vol.30Issue(6)：702-705,4.DOI:10.3870/yydb.2011.06.003
兰索拉唑片的生物等效性研究
Study on the Bioequivalence of Two Different Dose of Lansoprazole
摘要
Abstract
Objective To establish a simple and fast method for determing concentration of lansoprazole in human blood,and to estimate bioequivalence of two lansoprazole. Methods Chromatography was carried out on an Agilent C18 ( 250 mm×5 mm,5 μm ),with acetonitrile-water ( contained 1‰ triethylamine ) ( pH = 7.0 ) ( 30: 70 ) as mobile phase, at a flow rate of 1.0 mL · min- 1,at 285 nm of wavelength with the sample loaded at 20 μL. Results Twenty volunteers were randomly divided into 2 groups. A single oral dose of 10 mg of test or reference tablets was delivered to each volunteer in an open crossover test. The plasma concentration of bisoprolol hemifumarate was determined by HPLC-UV detection. Based on the parameters of pharmcokintic and relative bioavailability, the bioequivalance of bisoprolol hemifumarate was evaluated. The main pharmacokinetic parameters of the test prepartion were as follows: t1/2 were ( 2.19±0.49 ) and ( 2.38±0.48 ) h, tmax were ( 2.52±0.80 ) and ( 2.82 ±0.69 ) h, Cmax were ( 854.82 ±249.70 ) and ( 813.22 ±289.59 ) ng · mL- 1, AUC( 0- 12 h) were ( 3 513.00 ±742.25) and (3 779.90±1 191.52) μg · h · mL-1,AUC(0-∞) were (3 742.64±749.85) and (4078.54±1 171. 17)μg · h · mL-1 , respectively. Conclusion The preparations of test and reference are bioequivalent.关键词
兰索拉唑/色谱法,高效液相/生物等效性分类
医药卫生引用本文复制引用
张悦,张爱丽,李穆琼,王宝龙,秦向阳,李晓晔,孙晓莉,文爱东..兰索拉唑片的生物等效性研究[J].医药导报,2011,30(6):702-705,4.基金项目
化学Ⅰ类新药IDHP的药学研究基金资助项目(基金编号:2010K01-173) （基金编号:2010K01-173）
