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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 compare the relative bioavailability and bioequivalence of ferrous fumarate capsules produced by Harbin Jianlian Pharmaceutical Factory with Fuerxue oral liquid produced by Harbin Jianlian Pharmaceutical Factory as reference preparation. Methods: A total of 10 male adult healthy volunteers were enrolled in this study. Their self-controlled cross-over test methods were used respectively, 0.56g po Fuerxue oral liquid and 0.6g fumaric acid ferrous capsules were used. The concentration of blood plasma was determined by atomic absorption spectroscopy Photometric determination of plasma concentrations of time data using 3P87 program automatically fitted to calculate the pharmacokinetic parameters. Results: The time curve of plasma concentration of pooerfu oral liquid and ferrous fumarate capsules coincided with the one-compartment model. The tmax of the two preparations was 4.5 0 h with cmax of (1.66 ± 0 .1 1) mg · L-1 and (1.85 ± 0.32) mg · L-1; t1 / 2 were (1.27 ± 0.12) h and (1.18 ± 0 .0 9) h; AUC0 ~ ∞ were (5.21 ± 0.39) mg · h · L-1 and (5.44 ± 0.30) mg · h · L-1, The relative bioavailability of iron capsule and Furuxue oral solution was 97.75%. CONCLUSIONS: An ANOVA showed no significant difference in the main pharmacokinetic parameters between the two formulations (P> 0.05). Two-sided t-test showed that the two formulations were bioequivalent.