Preparation method of an iron and carbohydrate complex

A technology of carbohydrates and complexes, which is applied in the field of preparation of iron carbohydrate complexes and carboxymaltose iron, which can solve the problems of large molecular weight difference, large polydispersity index, and low product uniformity, and achieve good uniformity and high product quality. The effect of stable quality

Inactive Publication Date: 2018-06-08
JIANGSU AOSAIKANG PHARMA CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The inventor also found through experimental research that the carboxymaltose iron product prepared according to the

Method used

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  • Preparation method of an iron and carbohydrate complex

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Experimental program
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Effect test

Embodiment 1

[0029] Embodiment 1 Preparation of carboxymaltose iron

[0030] At 20-35°C, stir and dissolve 100g of maltodextrin (DE=11) in 300ml of purified water, add 13.8g of trioctylmethylammonium chloride and 0.7g of sodium bromide in turn, stir, and keep it at pH 10-10.5 Add 50g of tert-butyl hypochlorite, react for 3 hours, and adjust the pH to 13.0-13.5 with 30% NaOH solution.

[0031] Slowly add 432g ferric chloride solution (9.8% Fe, 205g ferric chloride hexahydrate dissolved in 227g water), 620g sodium carbonate solution (16.8%, 104g sodium carbonate dissolved in 516g water) to the above oxidized maltose In dextrin, react for 9 hours, adjust the pH to 10.5-11.5 with 30% sodium hydroxide solution, heat the solution to 45-50°C, react for 30 minutes, then adjust the pH to 5.0-6.0 with 37% hydrochloric acid, React at ~50°C for 30 minutes, then heat to 95-100°C, and continue to react for 30 minutes. After the solution was cooled to room temperature, the pH was adjusted to 6.0-6.5. ...

Embodiment 2

[0033]Embodiment 2 Preparation of carboxymaltose iron

[0034] Stir and dissolve 100g of maltodextrin (DE=11) in 300ml of purified water at 20-35°C, add 13g of tributylmethylammonium chloride and 0.7g of sodium bromide in turn, stir, and add 40g of it at pH 10-10.5 Tert-butyl hypochlorite, reacted for 3 hours, and adjusted the pH to 13.0-13.5 with 30% NaOH solution.

[0035] Slowly add 432g ferric chloride solution (9.8% Fe) and 620g sodium carbonate solution (16.8%) to the above oxidized maltodextrin, react for 10 hours, adjust the pH to 11.5-12.5 with 30% sodium hydroxide solution , heat the solution to 45-50°C, react for 30 minutes, then adjust the pH to 5.0-6.0 with 37% hydrochloric acid, react at 45-50°C for 30 minutes, then heat to 90-100°C, and continue the reaction for 30 minutes. After the solution was cooled to room temperature, the pH was adjusted to 6.0-6.5.

[0036] Add 20g of activated carbon to the reaction solution, filter it with diatomaceous earth after sti...

Embodiment 3

[0037] Embodiment 3 Preparation of carboxymaltose iron

[0038] At 20-35°C, stir and dissolve 100g of maltodextrin (DE=11) in 300ml of purified water, add 13.8g of trioctylmethylammonium chloride and 0.7g of sodium bromide in turn, stir, and keep it at pH 10-10.5 Add 16.5g sodium hypochlorite solution (14.6% active chlorine), 30g tert-butyl hypochlorite, react for 3 hours, and adjust the pH to 13.0-13.5 with 30% NaOH solution.

[0039] Slowly add 432g ferric chloride solution (9.8% Fe) and 620g sodium carbonate solution (16.8%) to the above oxidized maltodextrin, react for 8 hours, adjust the pH to 10.5-11.5 with 30% sodium hydroxide solution , heat the solution to 45-50°C, react for 30 minutes, then adjust the pH to 5.0-6.0 with 37% hydrochloric acid, react at 45-50°C for 30 minutes, then heat to 95-100°C, and continue the reaction for 30 minutes. After the solution was cooled to room temperature, the pH was adjusted to 6.0-6.5.

[0040] Add 20g of activated carbon to the r...

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Abstract

The invention provides a preparation method of an iron and carbohydrate complex, and particularly relates to a preparation method of ferric carboxymaltose. The preparation method of ferric carboxymaltose comprises the following steps: maltodextrin is oxidized by an oxidant containing tert-butyl hypochlorite in an alkaline aqueous solution in the presence of a phase transfer catalyst; the oxidizedmaltodextrin solution is subjected to a reaction with an aqueous solution of ferric iron salt, wherein the phase transfer catalyst is selected from one or more of quaternary ammonium salts such as trioctylmethylammonium chloride, tributylmethylammonium chloride, tributylmethylammonium bromide, tributylmethylammonium chloride, tetrabutylammonium chloride, and tetrabutylammonium bromide; the oxidantis tert-butyl hypochlorite or a combination of tert-butyl hypochlorite and sodium hypochlorite. Obtained ferric carboxymaltose has MW (molecular weight) of 150-230 kDa, Pd value of 1.2-1.3 and iron content of 26%-31%.

Description

technical field [0001] The invention belongs to the field of medicinal chemistry, and relates to an iron carbohydrate complex, especially a preparation method of carboxymaltose iron. Background technique [0002] Iron deficiency anemia (IDA) refers to insufficient iron storage in the body to maintain normal hematopoiesis, and iron demand exceeds supply. In severe cases, patients have microcytic hypochromic red blood cells with decreased mean corpuscular volume (MCV) and mean corpuscular hemoglobin concentration (MCHC). The World Health Organization (WHO) estimates that approximately 700 million people suffer from iron deficiency anemia (IDA). There are two types of iron supplements currently on the market: oral and injection: the advantage of oral iron is that it takes effect quickly, but it can greatly stimulate the gastric mucosa, so it needs to be taken between meals, and tea should be avoided when taking the medicine. In order to prevent iron from being precipitated by...

Claims

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Application Information

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IPC IPC(8): C08B37/02C08B30/18
CPCC08B30/18C08B37/0009
Inventor 陈庆财陈虹宇宗在伟赵骞杨瑞峰周长岭
Owner JIANGSU AOSAIKANG PHARMA CO LTD
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