Impurity Research Of Polysaccharideiron And Capsule

Iron deficiency anemia is becoming a global disease that affects human survival and health.Studies have shown that some cardiovascular and cerebrovascular diseases,renal failure,decreased immunity,postpartum blood loss,and incomplete mental development in infants are all related to iron deficiency anemia.If it is not treated in time,it will endanger the safety of the patient's life.At present,the general use of oral iron replacement therapy for the treatment of iron deficiency anemia.The experimental study on corn starch polysaccharide iron complex is a kind of high-quality oral iron,not only enable the body to maximize the absorption and utilization of the iron,but does not produce excessive cell toxicity,more significant effect.At the same time,this product is enteric-soluble sustained-release capsules to avoid stimulation of the gastrointestinal tract.For drug development,the research of impurities is the key link to ensure the quality of drugs.The source of the impurities and the steps to be introduced can reduce the amount of work for the purification of the effective components.Through the detection of inorganic impurities,organic impurities and degradation impurities in the self made corn starch polysaccharide iron complex,the safety and effective control of the raw material is controlled to ensure the smooth progress of the following process.The purpose of this study is to analyze the overall impurity of the corn starch polysaccharide iron complex material,establish a complete spectrum of impurities,and revise the current quality standards for impurities.The content of the process and degradation impurities can be controlled within a controllable range,so as to ensure the quality and safety of the polysaccharide iron complex.In this experiment,the homemade three batches raw materials as experimental materials,detect chloride ions,iron ions,heavy metals,arsenic salt and other inorganic impurities of them,the results for chloride turbidity is low and does not exceed the standard in 2%;iron color not deeper than the standard iron solution;heavy metal content shall not exceed 20ppm;arsenic spot color much shallower than standard color,in accordance with the provisions of the limitation of 5ppm;To determine the residual solvent of ethanol in the sample,the detection is less than the specified value of 0.5%;the main inorganic metal impurity free iron does not exceed0.02%;the reduction of glucose content of polysaccharides mainly organic impurities,the precipitation amount is less than the specified value of 0.2%;raw materials of high temperature,high humidity and light and alkali experiment was detected by high performance liquid chromatography and ultraviolet spectrophotometry,were not found to have generated new impurities.