铁-碳水化合物复合物的质量控制、评价与进展

Quality control,evaluation and progress of iron-carbohydrate complexes

非生物复合药物(NBCDs)是指一类通过化学方法合成、活性成分为结构相似的大分子复合物的混合物、现有物理和化学分析手段不能明确表征其结构的药物,主要包括铁-碳水化合物复合物、胶束、纳米乳、脂质体以及聚合物类药物等。铁-碳水化合物复合物是由氢氧化铁/氧化铁核心,以及外部包裹的碳水化合物外壳所组成的球形纳米颗粒,临床常用于治疗缺铁性贫血。铁-碳水化合物复合物在处方工艺、质量控制、一致性评价等方面均存在复杂性。本文主要就铁-碳水化合物复合物的监管、质量控制、一致性评价等方面进行介绍。

Non-biological complex drugs(NBCDs)are a kind of drugs synthesized by chemical methods,the active ingredients of which are mixtures of macromolecular complexes with similar structures,and the structures of which could not be clearly characterized by current physical and chemical analysis methods.NBCDs mainly include iron-carbohydrate complexes,micelles,nanoemulsions,liposomes and polymers.Iron-carbohydrate complexes are spherical nanoparticles composed of iron hydroxide/iron oxide cores and carbohydrate shells,and they are mainly used to treat iron deficiency anemia.There are complexities in formula,preparation technology,quality control and consistency evaluation of iron-carbohydrate complexes.This paper mainly introduces the regulation,quality control and consistency evaluation of iron-carbohydrate complexes.