法莫替丁口溶片的人体药代动力学及相对生物利用度研究

Study on Pharmacokinetics and Relative Bioavailability of Rapid Dissolving Tablet in Mouth of Famotidine in Health Volunteers

目的 比较法莫替丁口溶片和普通市售片的人体内药代动力学及相对生物利用度。方法 8名健康志愿者单剂量口含法莫替丁口溶片和口服法莫替丁普通市售片后 ,用高效液相色谱法测定血药浓度 ,进行口溶片与普通市售片的药代动力学和生物利用度研究。结果 两剂型血药浓度有显著差异 ,口溶片为 :AUC =(115 9.2 4± 391.49)ng·h·ml-1,Cmax =(2 13.97±78.90 )ng·ml-1,Tmax =(1.5 0± 0 .36 )h ,市售片的药动学参数为 :AUC =(719.5 3± 379.17)ng·ml-1,Cmax =(131.78± 6 7.5 3)ng·ml-1,Tmax =(2 .75± 0 .37)h ,口溶片与普通片的AUC的差异有统计学意义 (P <0 .0 1) ,相对生物利用度为 16 1.11%。

Aim To study the pharmacokinetics and bioavailability of rapid dissolving tablet of famotidine in mouth and famotidine market tablet.Methods Rapid dissolving tablets in mouth and market tablets of famotidine were single-dose oral given to eight health volunteers.The blood levels of famotidine were determined by HPLC method.The pharmacokinetics and relative bioavailability of rapid dissolving tablets in mouth and market tablets were investigated.Results The pharmacokinetic parameters of rapid dissolving tablets in mouth were:AUC=(1159.24±391.49)ng·h·ml -1 ,C max =(213.97±78.90)ng·ml -1 ,t max =(1.50±0.36)h, and the pharmacokinetic parameters of market tablets were:AUC=( 719.53±379.17)ng·h·ml -1 ,C max =(131.78±67.53)ng·ml -1 ,T max =(2.75±0.37)h,The statistical analysis for the AUC showed that there was significant difference (P<0.01) between the two products, The relative bioavailability was 161.11%.Conclusions The bioavailability of rapid dissolving tablets in mouth were higher than that of market tablets.