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

A weight-average molecular weight and stability control technology, applied in the field of iron dextran production, can solve the problems of affecting the product quality of iron dextran injection, high stress in piglets, difficulty in obtaining molecular weight distribution, etc. Quality controllable effects

Inactive Publication Date: 2021-02-26
SHANGHAI SHENYA ANIMAL HEALTH PROD FUYANG CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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 th

Method used

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Effect test

Embodiment 1

[0022] A production method for iron dextran weight average molecular weight and distribution coefficient stability control, comprising:

[0023] S01, hydrolysis of dextran: add 260kg of purified water into a 1000L reactor and heat to 100°C, add 100kg of dextran with a molecular weight of 20,000, heat and stir for 30 minutes to dissolve, and keep the kettle temperature at 100°C; add 6L of hydrochloric acid after the dextran dissolves, and Hydrochloric acid adopts the hydrochloric acid solution of 1:1 with water mass ratio, carries out hydrolysis heating and stirring for 15 minutes; In the dextran solution after the hydrolysis in the kettle, adding concentration is that about 8L of 50% sodium hydroxide solution is neutralized, and carries out rapid adjustment of pH value, will Adjust the pH value to 7, stop the hydrolysis of dextran, stir and naturally cool down to 80°C, replenish the evaporated water, and keep warm at 80°C for 30 minutes;

[0024] S02, complexation: naturally c...

Embodiment 2

[0028] A production method for iron dextran weight average molecular weight and distribution coefficient stability control, comprising:

[0029] S01, hydrolysis of dextran: add 260kg of purified water into a 1000L reactor and heat to 100°C, add 100kg of dextran with a molecular weight of 20,000, heat and stir for 30 minutes to dissolve, and keep the kettle temperature at 100°C; add 6L of hydrochloric acid after the dextran dissolves, and Hydrochloric acid adopts the hydrochloric acid solution of 1:1 with water mass ratio, carries out hydrolysis heating and stirring for 15 minutes; In the dextran solution after the hydrolysis in the kettle, adding concentration is that about 8L of 50% sodium hydroxide solution is neutralized, and carries out rapid adjustment of pH value, will Adjust the pH value to 8, stop the hydrolysis of dextran, stir and naturally cool down to 80°C, replenish the evaporated water, and keep warm at 80°C for 30 minutes;

[0030] S02, complexation: naturally c...

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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...

Claims

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Application Information

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IPC IPC(8): C08B37/02C08J3/12C08L5/02
CPCC08B37/0021C08J3/122C08J2305/02
Inventor 王勇谢继奎刘小兰王艳杨雪飞
Owner SHANGHAI SHENYA ANIMAL HEALTH PROD FUYANG CO LTD
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