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Preparation method of iron sucrose composite solution with low heavy metal content, and product

A technology with low heavy metals and complexes, applied in the field of medicine, can solve the problems of low removal rate of heavy metals, difficulties in development and stable production, etc., and achieve the effects of no accumulation risk of heavy metals, high safety, and low content of heavy metals

Inactive Publication Date: 2019-06-18
南京恒生制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the currently disclosed iron sucrose preparation process has a very low removal rate of heavy metals, which brings great difficulties to the development and stable production of iron sucrose complexes with low heavy metal content.

Method used

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  • Preparation method of iron sucrose composite solution with low heavy metal content, and product
  • Preparation method of iron sucrose composite solution with low heavy metal content, and product

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Add 110g of anhydrous sodium carbonate and 2.3kg of purified water into the 5L glass flask, stir for about 30min to dissolve, heat to 80°C, then add 250g of ferric chloride hexahydrate (manganese content 934ppm, nickel content 48.12ppm, cobalt content 9.88ppm) ), stirred and reacted for about 15min, the solution was black, filtered, and the filtrate was transferred to a 5L glass flask and cooled to 5°C. Add 20% sodium carbonate solution dropwise for about 5h to adjust the pH of the reaction solution to about 2.0, stir the reaction at 5°C for about 4h, adjust the pH of the reaction solution to about 7.0 with 20% sodium carbonate solution, stir for 30min and filter, the filter cake uses about 5kg The purified water was repeatedly washed 4 times, the conductivity of the washed purified water was 3342 μs / cm, the obtained ferric hydroxide colloid was added with sodium hydroxide to adjust the pH of the reaction solution to not less than 10, 1.3 kg of sucrose was added, and the...

Embodiment 2

[0047] Add 110g anhydrous sodium carbonate and 2.3kg purified water to the 5L glass flask, stir for about 30min to dissolve, heat to 60°C, then add 250g ferric chloride hexahydrate (manganese content 934ppm, nickel content 48.12ppm, cobalt content 9.88ppm) ), stirred and reacted for about 15min, the solution was black, filtered, and the filtrate was transferred to a 5L glass flask and cooled to 0°C. Add 20% sodium carbonate solution dropwise for about 5h to adjust the pH of the reaction solution to about 3.0, stir the reaction at 5°C for about 8h, adjust the pH of the reaction solution to about 8.5 with 20% sodium carbonate solution, stir for 30min and filter, the filter cake uses about 5kg The purified water was repeatedly washed 4 times, the conductivity of the washed purified water was 2490 μs / cm, the obtained ferric hydroxide colloid was added with sodium hydroxide to adjust the pH of the reaction solution to not less than 10, 1.0 kg of sucrose was added, and the reaction s...

Embodiment 3

[0049] Add 105g of anhydrous sodium carbonate and 2.3kg of purified water to the 5L glass flask, stir for about 30min to dissolve, heat to 50°C, then add 250g of ferric chloride hexahydrate (manganese content 934ppm, nickel content 48.12ppm, cobalt content 9.88ppm) ), stirred and reacted for about 15min, the solution was black, filtered, and the filtrate was transferred to a 5L glass flask and cooled to 5°C. Add 20% sodium carbonate solution dropwise for about 3h to adjust the pH of the reaction solution to about 2.3, stir the reaction at 5°C for about 8h, adjust the pH of the reaction solution to about 8.2 with 20% sodium carbonate solution, stir for 30min and filter, the filter cake uses about 5kg The purified water was repeatedly washed 5 times, and the conductivity of the washed purified water was 1216 μs / cm. The obtained ferric hydroxide colloid was added with sodium hydroxide to adjust the pH of the reaction solution to not less than 10, 0.9 kg of sucrose was added, and t...

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Abstract

The invention discloses a preparation method of an iron sucrose composite solution with the low heavy metal content, and a product. According to a preparation process of an iron sucrose composite, through unique ferric hydroxide intermediate preparation and purification processes and process control and by comprehensively considering heavy metal introduction of a complex reaction vessel, the removal rate of heavy metal can be remarkably increased, the problems that the risk of heavy metal element impurities in an existing iron sucrose crude drug process technology is high, and particularly thecontent of the heavy metal element impurities of manganese, nickel and cobalt is high are solved, the heavy metal toxicity of an iron sucrose intravenous iron supplement in a human body is effectively lowered, drug use safety is improved, and the advantages that process operation is easy, and industrialization is easy to realize are achieved.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a preparation method of a sucrose iron complex solution with low heavy metal content and a product thereof. Background technique [0002] Iron-deficiency anemia is one of the most common anemias in the world. It refers to a kind of hypochromic anemia caused by insufficient iron storage in the body. Insufficient iron intake, excessive iron loss, and iron malabsorption can all lead to the occurrence of iron-deficiency anemia. The most effective method is iron supplementation. [0003] Iron sucrose is a commonly used intravenous iron supplement, which has the advantages of high efficiency, rapidity, accurate localization, and low toxicity of parenteral administration. On the other hand, as an intravenous preparation, iron sucrose is used in a large amount at one time, and it directly enters the blood circulation system, so safety assurance is one of the major challenges of this ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/26A61K9/08A61P7/06A61P3/02C07H3/04C07H1/00A61K31/7016
Inventor 刘勇曹光龙汤传飞花传政
Owner 南京恒生制药有限公司
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