Iron dextran raw material for human intravenous injection and preparation method thereof

Abstract

The invention relates to an iron dextran raw material for human intravenous injection and a preparation method thereof. The iron dextran for human intravenous injection is prepared from dextran through hydrolysis, ultra-filtration or gel column separation, oxidation, complexing, ultra-filtration refining and ethanol precipitation or spray drying. For human injection, the dextran is pretreated after hydrolysis, the small molecular dextran of which the absolute molecular weight is 5000-8000 is prepared by separation with an ultra-filtration device or a gel column, an oxidant and an oxidation process are adjusted, sodium peroxycarbonate is used as the oxidant for oxidation, a final product is refined by separation with the ultra-filtration device or the gel column, and then the iron dextran raw material which has the weight-average molecular weight of 135000-190000 and the molecular weight distribution of less than 2.0 and can meet the human intravenous injection is obtained.

Description

technical field [0001] The invention relates to an iron dextran raw material for human intravenous injection and a preparation method thereof, belonging to the field of polysaccharide derivatives. Background technique [0002] About 24.8% of the world's population suffers from anemia, and the prevalence of anemia in China is about 20.1%, half of which is caused by iron deficiency. Iron deficiency and anemia are common complications of many serious conditions, including chronic kidney disease, chronic heart failure, chemotherapy-induced anemia, inflammatory bowel disease, heavy menstrual bleeding, and postpartum hemorrhage. Patients with chronic kidney disease, women of childbearing age, pregnant women, and developing children are high-risk groups for iron deficiency anemia. Iron dextran is an iron supplement, which is recorded in domestic and foreign pharmacopoeias. Its dosage forms include oral tablets, intramuscular injections, and intravenous injections. Domestically, i...

AI Technical Summary

Problems solved by technology

[0005] After hydrolyzing dextran, its weight average molecular weight is controlled within a certain range, but the distribution of absolute molecules may be very wide, which directly affects the molecular weight distribution of complexation later, resulting in a wider molecular weight distribution of iron dextran, which cannot meet the requirements of intravenous injection. Can be taken orally, but iron dextran is not well absorbed when taken orally

In the past, what used to prepare iron dextran was small molecule dextran with a certain weight-average molecular weight, and it was not refined; there are several methods for preparing oxidized dextran. 1. Potassium cyanide is used as an oxidant, but potassium cyanide is High toxicity, high toxicity; 2, use alkali solution to oxidize the alkali consumption of this method is bigger, and neutralize with acid after oxidation, the consumption of acid is large, and the waste liquid containing salt is many, and processing difficulty is big; 3, use sodium hypochlorite as The weak point of the method of oxidizing agent oxidation dextran this method is that sodium hypochlorite produces chlorine ion in reaction process and has bigger impact on environment, and consumption is more, and reaction time is too long; 4, use hydrogen peroxide as oxygenant, this method is unstable because of hydrogen peroxide, The content will change, so it is difficult to quantify in actual operation, and there are certain difficulties in actual use