富马酸亚铁胶丸相对生物利用度及药代动力学  

Relative bioavailability and pharmacokinetics of ferrous fumarate soft capsule

作　　者：赵红光[1] 杜智敏[1] 张一飞[1] 陆义诚[1] 郑心明[1] 

机构地区：[1]哈尔滨医科大学附属第二医院临床药学药物研究所,哈尔滨150086

出　　处：《中国药学杂志》2000年第3期179-181,共3页Chinese Pharmaceutical Journal

摘　　要：目的 :以哈尔滨健尔制药厂生产的富尔血口服液为参比制剂 ,比较哈尔滨健尔制药厂生产的富马酸亚铁胶丸的相对生物利用度和生物等效性。方法 :选择 1 0名男性成年健康志愿者 ,用自身交叉对照试验方法 ,分别 po富尔血口服液 0 .5 6g ,富马酸亚铁胶丸 0 .6 g ,血药浓度用原子吸收分光光度仪测定 ,血药浓度 时间数据用 3P87程序自动拟合 ,求算药代动力学参数。结果 :po富尔血口服液及富马酸亚铁胶丸两种制剂的血药浓度 时间曲线符合一室模型 ,两种制剂的tmax均为 4.5 0h ,cmax分别为 (1 .6 6± 0 .1 1 )mg·L-1和 (1 .85± 0 .32 )mg·L-1;t1/ 2 分别为 (1 .2 7± 0 .1 2 )h和 (1 .1 8± 0 .0 9)h ;AUC0～∞ 分别为 (5 .2 1±0 .39)mg·h·L-1和 (5 .44± 0 .30 )mg·h·L-1,富马酸亚铁胶丸和富尔血口服液比较的相对生物利用度为 97.75 %。结论 :经方差分析表明两种制剂的主要药代动力学参数间无显著性差异 (P >0 .0 5 ) ,经双单侧t检验 ,两种制剂具有生物等效性。OBJECTIVE:To investigate the relative bioavailability and pharmacokinetics of Ferrous Fumarate soft capsule,and to evaluate the bioequivalence between the soft capsule and oral solution.METHODS:0.56 g oral solution (or 0.6 g soft capsule) was given to 10 healthy volunteers according to cross over design.Drug concentrations in serum were assayed by atomic absorption spectrometry.The pharmacokinetic parameters were measured by 3P87 program.RESULTS:The concentration time curve of Ferrous Fumarate soft capsule was fitted to one compartment open model.The pharmacokinetic parameters of Ferrous Fumarate oral solution and Ferrous Fumarate soft capsule:were t max 4.50 h; c max (1.66±0.11) mg·L -1 and (1.85±0.32)mg·L -1 ; t 1/2 (1.27±0.12) h and (1.18±0.09) h; AUC 0～∞ (5.21±0.39)mg·h·L -1 and (5.44±0.30) mg·h·L -1 ,respectively.The relative bioavailability of Ferrous Fumarate soft capsule was 97.75%.CONCLUSION:The pharmacokinetic parameters between two products had no significant difference ( P >0.05).The two formulations were of bioequivalence.

关 键 词：富马酸亚铁 药代动力学 生物利用度 胶丸 

分 类 号：R977.9[医药卫生—药品] R969.1[医药卫生—药学]