富马酸亚铁胶丸相对生物利用度及药代动力学

 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10名男性成年健康志愿者，用自身交叉叶照试验方法，分别 po 富尔血口服液0.56g，富马酸亚铁胶丸0.6g，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一时间曲线符合一室模型，两种制剂的t〈sub〉max〈/sub〉均为4.50 h，c〈sub〉max〈/sub〉分别为(1.66±0.I1)mg·L〈sup〉-1〈/sup〉和(1.85±0.32)mg·L〈sup〉-1〈/sup〉；t〈sub〉1/2〈/sub〉分别为(1.27士.12)h和(1.18士0.09)h；AUC〈sub〉o～∞〈/sub〉，分别为(5.21士0.39)mg·h·L〈sup〉-1〈/sup〉和(5.44士0.30)mg·h·L〈sup〉-10.05)，经双单侧t检验，两种制剂具有生物等效性。

Relative bioavailability and pharmacokinetics of ferrous fumarate soft capsule

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^-1and (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^-1and (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.