Iron dextran weight-average molecular weight and distribution coefficient stability control production method

Abstract

The invention discloses an iron dextran weight-average molecular weight and distribution coefficient stability control production method which comprises the following steps: S01, hydrolysis of dextran: hydrolyzing dextran under an acidic condition to reduce the molecular weight; s02, complexing: reacting ferric trichloride with sodium hydroxide to produce ferric hydroxide, and complexing ferric hydroxide with dextran to produce iron dextran; s03, nanofiltration: removing salt, heavy metals and free iron impurities in the complexing solution by adopting an ultrafiltration process, and concentrating the complexing solution; and S04, spray drying: adding the qualified ultrafiltration solution into spray drying equipment, and carrying out spray drying to obtain powder. The iron dextran with stable weight-average molecular weight and distribution coefficient is produced, and the weight-average molecular weight (Mw) of the iron dextran raw material and the preparation is accurately controlled to be about 6000, so that the internal quality and the clinical treatment effect of the iron dextran raw material and the preparation are improved.

Description

Technical field: [0001] The invention relates to the technical field of iron dextran production, in particular to a production method for controlling the weight-average molecular weight and distribution coefficient stability of iron dextran. Background technique: [0002] Iron dextran is a commonly used anti-anemia drug, which is a complex of dextran with a weight-average molecular weight of 5000-7500 and iron hydroxide, and the iron content is not less than 25.0%. Iron dextran injection is currently the most widely used iron supplementation injection to prevent and treat iron deficiency anemia in piglets. The first quality standard of "Chinese Veterinary Pharmacopoeia" 2015 edition requires that the weight average molecular weight (Mw) of iron dextran raw materials and preparations should be 5000-7500. At present, the production process of most domestic veterinary drug companies is difficult to produce iron dextran injection products that meet the national standard. The we...

AI Technical Summary

Problems solved by technology

At present, the production process of most domestic veterinary drug companies is difficult to produce iron dextran injection products that meet the national standard. The weight average molecular weight (Mw) of iron dextran injection sold in the domestic market basically exceeds 10,000, which does not meet the requirements of the national standard. The root cause is iron dextran injection. The weight-average molecular weight of the raw material and its high distribution coefficient do not meet the requirements of the national standard

[0003] Precise control of the weight average molecular weight (Mw) between 5000 and 7500 is very important for the effect of iron supplementation, and directly affects the product quality of iron dextran injection. A large molecular weight is not conducive to the body's absorption of the drug after intramuscular injection. If the injection is too severe, it will often cause black necrotic foci or lumps at the injection site, which will affect the carcass quality of pigs

[0004] Although the high-molecular dextran is produced by the enzymatic method, the high-molecular dextran is degraded by the acid hydrolysis method. The production cost is high, and it is extremely difficult to obtain ultra-micro-molecular dextran with a narrow molecular weight distribution.