Research On Iron Polysaccharide Complex Capsules Small Test

Iron deficiency anemia(IDA)is a common nutritional disease in modern society due to lack of dietary iron content,iron malabsorption and excessive loss of body of iron.Oral iron supplementation is clearly the best choice of cheap and effective treatment and prevention of human iron deficiency anemia.A new type of iron,iron polysaccharide complex can be well absorbed by the body,and has the side effect of high stability,good water solubility and less,is the most studied drug for the treatment of iron deficiency anemia.In this paper,the formulation of pellets was optimized by the dissolution test,and a new type of iron supplement with low price,high bioavailability and less side effects was prepared.In this paper,prescription drugs before,established the general method of iron content of nonyl phenol detection of corn starch polysaccharide iron pellets,and the method was accuracy,precision,specificity and linearity method validation,to ensure the phenanthroline determination of iron content in science.In order to avoid the effects of the excipients on the stability of the drugs,the compatibility test of the raw materials was carried out,and the appropriate excipients were screened out.Natural zein is used as a skeleton material and PVP k30 is used as adhesive to prepare cytoskeleton corn starch polysaccharide iron enteric sustained-release pellets.The quality evaluation criteria of pellets were established,including the yield of pellets,the yield of pellets,the roundness,hardness and bulk density.Pellets with diameter of pellets ranging from 0.701 to 0.991 mm were pellets. Corn starch polysaccharide iron pellets were prepared by centrifugal granulation.According to the quality evaluation criteria of pellets,the effects of formulation factors and process parameters on pellets were investigated. Among them,prescription factors include blockers,adhesives,and wetting agents.The main parameters include main engine speed,shotcreting speed,jet pressure and powder feeding speed.After comprehensive evaluation of pellets,the main engine speed is 200r/min,the spraying speed is 20r/min,the jet pressure is 0.02 MPa,and the powder feeding speed is 25r/min.Corn starch polysaccharide iron complex is very soluble in water.Previous experiments also proved that the corn starch polysaccharides and iron complex had strong hygroscopicity.Therefore,the pellets prepared must be wrapped in a layer of isolation to reduce the hygroscopicity of pellets. The corn starch polysaccharide iron enteric coated sustained-release pellets were prepared by adjusting the proportion and dosage of corn gluten and polyvinylpyrrolidone K30,and increasing the isolation layer by single factor experiment. It is preliminarily determined that the ratio of zein to polyvinylpyrrolidone K30 is 4:1,the total amount of the two kinds of excipients is 30 g,and the weight gain of the isolation layer is 4%.According to single factor experiment before the response surface optimization of experimental design,in the response surface model equations and response analysis of surface and contour map,and ultimately determine the zein and polyvinylpyrrolidone K30 ratio is 2.880:1,the total amount of two kinds of accessories for 29.030 g,the isolation layer weight increased by 2.61%.The quality control and stability of the prepared pellet capsules were studied. The study of quality control mainly includes appearance,iron content,dissolution,free iron content and detection of residual solvents. In the study of stability,the influence factors experiment,accelerated test and long term test were mainly conducted.The influencing factors experiments included high temperature,high humidity and strong light irradiation. The iron content and dissolution of pellets are not affected by high temperature,high humidity and light.Their properties are stable.However,the water content of pellets varies greatly in high humidity environment,which requires us to carry out subsequent packaging,transportation and storage in a dry environment.