Studies On Preparation Process Of Medicine For The Treatment Of Iron Deficiency Anemia

Iron deficiency anemia is an important global nutritional problems,can lead to decreased immunity,cardiovascular diseases,anemia in infants even affect the development of brain cells resulting in mental retardation.Iron supplements have been an effective method for the treatment of iron deficiency anemia.As a new type of iron agent,Polysaccharide iron complex can avoid the poor chemical stability,low bioavailability and other side effects of the traditional ferrous preparation,and the curative effect is distinct,which is widely studied by domestic and foreign researchers.Based on the absorption and utilization mechanism of polysaccharide iron complex,this paper aims to prepare a kind of polysaccharide iron complex enteric-coated pellets with higher utilization rate.Through the analysis and comparison with standard iron solution and accessories,a method for the determination of iron content and release rate of polysaccharide iron complex pellets by o-phenanthroline spectrophotography was established,the standard curve was also established.The validation results showed that the method was scientific and reliable.The compatibility results of raw/ auxiliary materials show that enteric materials easy to react with the main drug,So they should be separated from each other in the coating process.The polysaccharide iron complex pellets were prepared with centrifugal granulation.Through single factor experiments we got the optimal prescription was: 50% ethanol solution as solvent,the concentration of PVPK30 is 2%,The dosage of silica is 4% of PVPK30.Based on the results of single factor experiments,response surface experiments and analysis was carried out to optimize the key process parameters,the final result was: when the wheel speed was 224 rpm,liquid supply speed was 10.4rpm and the feeding rate of powder was 8.7rpm,the target nuclear yield was 90.42%.The fluid bed was adopted to prepare polysaccharide iron complex enteric-coated pellets.HPMC(E5)was used as the isolation layers material,Acryl-EZE 93F19255 was used as enteric material.Single factor experiment was designed to optimization formulation and process of coating.The prescription of isolation layers was: 70% ethanol solution as solvent,the concentration of HPMC(E5)is 2%,the addition of silica and SDS was 15% and 0.5% of HPMC(E5)respectively,the final isolation layer coating amount was 5%.An orthogonal experiment was designed to obtain better process parameters,when material temperature was 40?,atomization pressure was 0.07 MPa and liquid supply speed was 10 rpm,the isolation coating effect was good.Preparation of enteric coating liquid refer to the usage of Acryl-EZE 93F19255,the dosage of PEG4000 is 8% of enteric coating material,the final coating amount was 25%;when material temperature was 28-32?,atomization pressure was 0.07 MPa and liquid supply speed was 8rpm,the release of the enteric-coated pellets in acid solution was less than 10% within 2h and that in pH6.8 PBS was more than 80.00%,which conformed to the criterion of pharmacopoeia.The preliminary stability research of polysaccharide iron complex enteric-coated pellets showed that the pellets should be kept in dry environment.