多糖铁胶囊的人体生物等效性研究

Study on Bioequivalence of Polyferose Capsules

目的 :评价多糖铁胶囊与进口制剂力蜚能胶囊的生物等效性。方法 :20名男性健康受试者 ,采用单剂量、随机、自身交叉对照试验设计 ,空腹口服多糖铁胶囊与力蜚能胶囊150mg,采集12h内动态血标本 ,用原子吸收光谱法测定血清铁浓度并计算Cmax、Tmax、AUC0～t、AUC0～∞等相关参数 ,以双单侧t检验判断两制剂是否具有生物等效性。结果 :多糖铁胶囊和力蜚能胶囊的AUC0～t均为6 58( μg·h)/ml,Cmax 分别为1 07、1 10μg/ml ,Tmax 均为3 93h ,T1/2 均为2 33h ,AUC0～∞分别为6 95、6 93( μg·h)/ml。两组参数均无统计学差异 (P>0 05) ;AUC0～t、Tmax 和Cmax 经双单侧t检验证明亦无显著性差异。结论 :多糖铁胶囊的相对生物利用度为101 02 % 。

OBJECTIVE:To study the bioequivalence of polyferose capsule and imported Niferex in healthy volunˉteers.METHODS:In a randomized two-way crossover design,a single oral dose of150mg polyferose capsule(A)and Niferex(B)were given to20male healthy volunteers.The serum iron concentrations within12h after administration were determined with atomic absorption spectrometry and parameters C max ,T max ,AUC 0～t and AUC 0～∞ were obtained and analysed with two-one sided t test.RESULTS:The AUC 0～t ,C max ,T max ,T 1/2 and AUC 0～∞ of A and B were6.58μg/(h·ml)and6.58μg/(h·ml),1.07μg/ml and1.10μg/ml,3.93h and3.93h,2.33h and2.33h,6.95μg/(h·ml)and6.93μg/(h·ml)respectively.There were no significant difference between A and B(P>0.05)and the differences of AUC 0～t ,T max and C max were not significant as verified by two-one sided t test.CONCLUSION:The relative bioequivalence of polyferose capsules is101.02%which indicates that polyferose capsule is a bioequivalent product of Niferex capsule.