兰索拉唑肠溶片人体生物利用度及生物等效性研究  

Sudies on pharmacokinetic and bioquiavailability of lansoprazole enteric tablets in healthy volunteers

作　　者：邵志梅 张静[2] 刘云[2] 

机构地区：[1]盐城市第四人民医院,盐城224002 [2]南京医科大学第一附属医院,南京210029

出　　处：《药学与临床研究》2008年第6期453-456,共4页Pharmaceutical and Clinical Research

摘　　要：目的:研究兰索拉唑肠溶片人体生物利用度及生物等效性。方法:22例健康志愿受试者交叉口服兰索拉唑肠溶片和兰索拉唑胶囊剂各30 mg,以非那西丁为内标,HPLC-UV法测定血浆中兰索拉唑浓度。结果与结论:健康志愿者口服两种制剂各30 mg后,Cm ax分别为(1 057.26±230.42)ng.mL-1和(1 336.35±288.88)ng.mL-1;tm ax分别为(2.6±0.6)h和(2.1±0.6)h;t1/2分别为(1.85±0.28)h和(1.75±0.34)h;AUC0-12分别为(3 565.34±1 233.03)h.ng.mL-1和(3 951.22±1 375.82)h.ng.mL-1。各参数经统计学配对t检验,均无显著性差异(P>0.05)。兰索拉唑肠溶片与兰索拉唑胶囊剂在健康志愿者体内的药动学参数相似。Object ve：To study the pharmacokinetic and bioavailability of lansoprazole enteric tablets in healthy male volunteers. Methods： 22 healthy volunteers administrated with lansoprazole enteric tablets and lansoprazole capsules 30 mg respectively in a random crossover study, Plasma concentration was detected by reverse-phase HPLC with phenacetin as internal standard. Results and Conclusion： The statistic data of the main pharmaeokinetic parameters were as follows： Cmax were （ 1 057.26 ± 230.42） ng· mL^-1 and （ 1 336.35 ± 288.88 ） ng· mL^-1 ; tmax were （2.6 ± 0.6） h and （2.1 ± 0.6） h ; t1/2 were （ 1.85 ± 0.28 ） h and （ 1.75 ± 0.34） h ; AUC0-12 were （3 565.34 ± 1 233.03 ） h·ng·mL^-1 and （3 951.22 ± 1 375.82）h·ng·mL^-1, respectively. There are no significant difference in the pharmacokinetic parameters between the lansoprazole enteric tablets and lansoprazole capsules.

关 键 词：兰索拉唑 肠溶片 胶囊剂 生物利用度 生物等效性 高效液相色谱法 

分 类 号：R969.1[医药卫生—药理学]