Quality Rearch Of Polysaccharide Iron Active Pharmaceutical Ingredient

Iron deficiency anemia is an iron deficiency disease around the world,and it is harmful to the human body.Therefore,it is of great significance for the study of iron supplements.Polysaccharide iron complex belongs to the third generation iron supplements,with perfect stability,good water-solubility,easy absorption,high bioavailability,less toxic side effects and other characteristics,and it can be effective in the treatment of iron deficiency anemia.Quality research of active pharmaceutical ingredient(API)is an important part of drug research and development.The quality research of polysaccharide iron API can ensure the safety,effectiveness,controllability of quality as well as the stability of its production quality.It can lay a foundation for future industrial production.Three batch of pilot materials synthesized in this laboratory are used for quality research experiments on this research.The research content mainly includes properties,identification,purity check,determination.The physical properties and impurities results show that the polysaccharide-iron complex is brownish black,which is soluble in water,insoluble in ethanol and other organic solvents and it has high hygroscopicity.The identification test results show that the main components of the complex are polysaccharides and iron ions,and polysaccharide has been effectively complexed with iron ions;chloride content is not more than 2%;free iron content does not exceed 0.2%;heavy metal content lead is not more than twenty ppm;arsenic content is not more than five ppm;the residual solvent ethanol content was not more than 0.5%;the free Fe2+ content was between0.02%~0.04%.The determination of content results showed that the principal component iron content was between 40%~48%.The methodology experimentalresults show that the methods are accurate and reliable,and can meet the need of analysis.All the results show that the quality of these three batches of the formulation can meet Pharmacopoeia requirements.Our research can provide some experience for the development of domestic polysaccharide iron complex preparation.Because of the uncertainty of the structure of polysaccharide iron complex,it is difficult to guarantee the stability of the quality.We conduct a comprehensive study of its quality research to ensure the production of high-quality drugs.