富马酸亚铁叶酸片中铁的人体生物等效性研究

Bioequivalence of Iron from Ferrous Fumarate and Folic Acid Tablets in Healthy Volunteers

目的:研究富马酸亚铁叶酸片中铁在健康志愿者体内的生物利用度及生物等效性。方法:24例健康志愿者分别随机交叉口服受试制剂(富马酸亚铁叶酸片:一次2片,含富马酸亚铁304 mg×2,叶酸0.35 mg×2),参比制剂1(富马酸亚铁片:一次3片,200 mg×3)和参比制剂2(叶酸片:一次2片,0.4 mg×2),采用原子吸光分光光度法测定血中铁的浓度。结果:健康志愿者口服受试制剂和参比制剂后,铁的Cmax分别为(1.70±0.53)μg·mL-1和(1.61±0.62)μg·mL-1;Tmax分别为(4.0±1.0)h和(4.3±1.5)h;AUC0-24 h分别为(14.4±8.5)μg·h·mL-1和(14.3±8.1)μg·h·mL-1;t1/2分别为(3.3±2.9)h和(3.2±2.3)h。Cmax、AUC0-24 h和AUC0-∞剂量校正后经双向单侧t检验和(1-2α)置信区间生物等效性评价,Tmax经非参数检验(Wilcoxon符号秩法)均无显著性差异(P>0.05)。结论:根据铁的结果判定,富马酸亚铁叶酸片和富马酸亚铁片生物等效。

Objective： To study the bioavailability and bioequivalence of iron from ferrous fumarate and folio acid tablets in heahhy vohmteers. Methods： Twenty four heahhy volunteers administered the test fornulation （2 tablels of ferrous fumarate and folio acid, each containing 304 mg ferrous fumarate and 0.35 mg folie aeid） or reference formulation 1 （3 tablets, each containing 200 mg ferrous fumarate） anti reference formulation 2 （2 tablets, each containing 0.4 mg folio acid） in a random crossover study. Plasma iron concentrations were detected by atomic absorption spectrometry. Results： The main iron pharmacokinetic parameters of the test and reference formulations were as follows： C were （1.70±0.53） μg·mL-1 and （1.61± 0.62） μg·mL-1; Tmax were （4.0±1.0）h and （4.3±1.5）h; AUC0-24h were （14.4±8.5）μg·h·mL-1 and （14.3±8.1）μg·h·mL-1; t1/2 were （3.3±2.9）h and （3.2±2.3）h, respectively. Conclusion： There is no significant difference of the pharmacokinetic parameters of iron between the test anti reference formulations. The two iron formulations were bioequivalent according to the results.