关键词: font-size:medium, ">羧基麦芽糖铁；补铁剂；仿制药；质量控制

Abstract: Objective：To study the quality control method of ferric carboxymaltose injection and to evaluate the consistency of generic drugs. Methods：Ferric carboxymaltose samples were prepared by the optimized ferric-carbohydrate preparation method. The particle size of ferric carboxymaltose was determined by dynamic light scattering method and the nanoparticles were observed by electron microscopy. The relative molecular weight of ferric carboxymaltose was determined by chromatography， and the content of glycosylated ligand was determined by atomic absorption method. The particle size of ferric core was detected by X-ray powder diffraction， those compared with the ferric carboxymaltose original drug. Results： The particle size， molecular weight， iron core particle size， sugar ligand content and iron content of the self-made ferric carboxymaltose sample were similar to those of the original sample， indicating that the properties of ferric carboxymaltose prepared by the improved method were similar to those of the original drug. Meanwhile， dynamic light scattering， electron microscopy， chromatography， atomic absorption spectrometry and X-ray powder diffraction can be used to evaluate the quality of ferric carboxymaltose. Conclusion： Effective method to control ferric carboxymaltose quality evaluation， is effective to improve the quality control of generic drugs of ferric carboxymaltose， to ensure the quality of generic drugs and efficacy of consistency with the original drug， and provide technical reference for the consistency research of quality and efficacy of the generic drugs.

Key words: Ferric carboxymaltose(FCM), Iron supplements, Generic drug, Quality control