兰索拉唑片的生物等效性研究  

Study on the Bioequivalence of Two Different Dose of Lansoprazole

作　　者：张悦[1] 张爱丽[1] 李穆琼[1] 王宝龙[1] 秦向阳[1] 李晓晔[1] 孙晓莉[1] 文爱东[2] 

机构地区：[1]第四军医大学药学系化学教研室,西安710032 [2]第四军医大学西京医院药剂科,西安710032

出　　处：《医药导报》2011年第6期702-705,共4页Herald of Medicine

基　　金：化学Ⅰ类新药IDHP的药学研究基金资助项目(基金编号:2010K01-173)

摘　　要：目的建立反相高效液相色谱法测定兰索拉唑的血浆浓度,并研究其生物等效性。方法以AgilentC18(250 mm×5 mm,5μm)为色谱柱;流动相为乙腈-1‰三乙胺水溶液(pH=7.0)(30:70),流速1.0 mL.min-1,进样量为20μL,内标为奥美拉唑。血浆样品经乙酸乙酯提取后于285 nm紫外光检测。结果 20例健康受试者单次口服兰索拉唑片后,受试制剂与参比制剂的血浆中兰索拉唑的半衰期(t1/2)分别为(2.19±0.49)和(2.38±0.48)h,达峰时间(tmax)分别为(2.52±0.80)和(2.82±0.69)h,血药峰浓度(Cmax)分别为(854.82±249.70)和(813.22±289.59)ng.mL-1,血药浓度-时间曲线下面积(AUC0-12 h)分别为(3 513.00±742.25)和(3 779.90±1 191.52)μg.h.mL-1,AUC(0-∞)分别为(3 742.64±749.85)和(4 078.54±1 171.17)μg.h.mL-1。结论两种制剂的兰索拉唑片具有生物等效性。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,5μm） ,with acetonitrile-water （contained 1%c 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 pharmacokintic and relative bioavailability, the bioequivalance of bisoprolol henmfumarate was evaluated. The main phannacokinetic parameters of the test prepartion were as follows： t l/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（0-12h） 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 （4 078.54± 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 号：R975.2[医药卫生—药品] R969[医药卫生—药学]