Study On The Synthesis Of Ferric Carboxymaltose

Iron deficiency anemia is a common nutritional disease. It is caused by the shortage of iron in body which can’t meet the normal needs of erythropoiesis. The traditional medicine for treatment of iron deficiency anemia is inorganic iron supplement, it has a lot of shortcomings such as severe side effects. Ferric carboxymaltose can overcome these shortcomings and have the advantages of good stability, good solubility and high iron content.Synthetic route is determined on the basis of the synthetic method of ferric carboxymaltose in Vifor’s patent. First, maltodextrin of specific dextrose equivalent value is oxidized by oxidants such as sodium hypochlorite. Then ferric chloride solution is added to the above reaction solution. At last, the product is obtained after a series of pH changes.The feasibility of the synthetic route is proved by experiments. Also, the influence of process parameters on product molecular weight are investigated. The following parameters are considered:1, the DE value of maltodextrin; 2, the amount of ferric chloride hexahydrate; 3, the concentration of sodium carbonate solution; 4, the dropping speed of sodium carbonate solution; 5, the reaction time; 6, the reaction temperature; 7, the pH value of reaction solution.According to the changes of molecular weight under different reaction conditions, we can conclude that:20.28 is selected as the DE value of maltodextrin; 1.7:1 is selected as the mass ratio of maltodextrin to ferric chloride hexahydrate; 1M is selected as the concentration of sodium carbonate solution; 4h is selected as the dropping time; 5-6h is selected as the reaction time; 50 ℃ is selected as the reaction temperature; 11 is selected as the reaction pH.Parallel tests show that the product yield and iron content are stable, and the product molecular weight is similar to Ferinject of Vifor.