摘要
目的 :比较国产和进口泮托拉唑肠溶片的相对生物利用度。方法 :8名健康男性受试者交叉 po单剂量国产和进口泮托拉唑肠溶片 40mg ,采用HPLC测定血浆中泮托拉唑浓度。 结果 :国产及进口制剂的体内药动学主要参数分别为 :cmax为(2 932 .3± 6 6 5 .8)和 (32 5 1.9± 731.4) μg·L-1;tmax为 (2 .9± 0 .7)和 (2 .9± 0 .6 )h ;AUC0～∞ 为 (992 0 .7± 5 2 5 0 .9)和 (10 890 .1±6 0 15 .6 ) μg·h·L-1;t1/2 为 (1.8± 0 .4)和 (2 .1± 0 .4)h ;MRT为 (4.8± 1.0 )和 (4.7± 0 .7)h。国产制剂的平均相对生物利用度为 (92 .8± 10 .1) %。结论 :经统计学分析 ,两种制剂为生物等效制剂。
OBJECTIVE:To compare the relative bioavailability of domestic and imported pantoprazole tablet.METHODS:In randomized crossover design,single dose of pantoprazole domestic tablet or imported tablet 40 mg was given to 8 healthy male volunteers.Plasma concentration was determined with HPLC method.RESULTS:The pharmacokinetic parameters of domestic and imported products were c max :(2932.3±665.8),(3251.9±731.4) μg·L -1 ; t max (2.9±0.7),(2.9±0.6) h; AUC 0～∞ (9920.7±5250.9),(10890.1±6015.6) μg·h·L -1 ; t 1/2 :(1.8±0.4),(2.1±0.4) h;MRT:(4.8±1.0),(4.7±0.7) h,respectively.CONCLUSION:The results demonstrated that there were no statistically significant difference between the two products in AUC obtained from the studies.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2000年第5期329-331,共3页
Chinese Pharmaceutical Journal
