羧基麦芽糖铁制备工艺研究

The Preparation Process Study of Ferric Carboxymaltose

羧基麦芽糖铁是一种由碳水化合物外壳包裹氢氧化铁核形成的新型铁复合物,主要用于缺铁性贫血的治疗,注射时间短,可大剂量静脉给药。本文以麦芽糖糊精和三氯化铁为原料,对羧基麦芽糖铁的制备工艺进行了摸索和优化,确定了最优工艺参数。所得产品在铁含量、糊精含量、分子量、分子量分布、稳定性等方面与原研品基本一致。

Ferric carboxymaltose is a novel iron complex consisting of a carbohydrate shell and an iron hydroxide core.Ferric carboxymaltose is mainly used for iron deficiency anemia.Ferric carboxymaltose was prepared from maltodextrin and Ferric chloride.The preparation process was explored and optimized,and the optimal process parameters were determined.The product is identical to the original product in terms of iron content,dextrin content,molecular weight,molecular weight distribution,and stability.