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Preparation method of ferric carboxymaltose

A carboxyl maltose iron, carboxyl maltose technology, applied in the field of pharmaceutical chemical industry, can solve problems such as molecular weight control of carboxyl maltose iron, and achieve the effects of great practical significance, simple method and low technical requirements

Active Publication Date: 2021-06-22
JINLING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0008]Related patents CN106977621A, CN108129582A, CN1705682A (original research patent) etc. all involve the synthesis of carboxymaltose iron, but there is no corresponding description on the molecular weight control of carboxymaltose iron

Method used

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  • Preparation method of ferric carboxymaltose
  • Preparation method of ferric carboxymaltose
  • Preparation method of ferric carboxymaltose

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Maltodextrin 100g, add 200ml of water and stir to dissolve, add 1g of sodium bromide, add 30% sodium hydroxide solution to adjust the pH of the maltodextrin solution to 9.0-11.0, control the temperature at 25-40°C, add 10% sodium hypochlorite under stirring Solution 80g, obtain carboxyl maltodextrin solution.

[0037] Carboxymaltodextrin solution and ferric chloride solution (concentration of ferric chloride 75% w / w, prepared by adding 220 g of ferric chloride hexahydrate and water) were first mixed, stirred, temperature controlled at 50-70°C, and peristaltic Add sodium carbonate solution (concentration 25% w / w, prepared by adding water to 110 g of sodium carbonate) dropwise by the pump at a constant speed, set the flow rate, and control the addition of sodium carbonate solution within 0.3 hours. After completion of the reaction, add 30% sodium hydroxide solution to adjust the pH value of the solution to 10.0 to 12.0, control the temperature at 50 to 70° C., and stir fo...

Embodiment 2

[0039] The preparation of carboxy maltodextrin solution is the same as in Example 1.

[0040] Carboxymaltodextrin solution and ferric chloride solution ((concentration of ferric chloride 75% w / w, prepared by adding water to 220 g of ferric chloride hexahydrate) were first mixed, stirred, and the temperature was controlled at 50-70°C, and Add sodium carbonate solution (concentration 25% w / w, prepared by adding water to 110g of sodium carbonate) with the peristaltic pump at a constant speed, set the flow rate, and control the addition of sodium carbonate solution within 0.5 hours. After the reaction is completed, it will be cured by acid, alkali and high temperature Obtain stable iron carboxy maltose solution, then add 160 ml of absolute ethanol to precipitate iron carboxy maltose.

Embodiment 3

[0042] The preparation of carboxy maltodextrin solution is the same as in Example 1.

[0043]Carboxymaltodextrin solution and ferric chloride solution (concentration of ferric chloride 75% w / w, prepared by adding 220 g of ferric chloride hexahydrate and water) were first mixed, stirred, temperature controlled at 50-70°C, and peristaltic Pump the sodium carbonate solution (concentration 25% w / w, prepared by adding water to 110 g of sodium carbonate) dropwise at a constant speed, set the flow rate, and control the addition of the sodium carbonate solution within 1.0 hour. After the reaction is completed, solidify with acid, alkali and high temperature to obtain a stable iron carboxy maltose solution, and then add 160 ml of absolute ethanol to precipitate iron carboxy maltose.

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Abstract

The invention discloses a preparation method of ferric carboxymaltose, which comprises the steps of adding a sodium carbonate solution into a mixed system of a carboxyl maltodextrin solution and a ferric trichloride solution at a constant speed within 0.3-4 hours, and controlling the adding speed of the sodium carbonate solution to obtain ferric carboxymaltose with target molecular weight and molecular weight distribution coefficient, wherein in terms of ferric trichloride hexahydrate, the mass ratio of ferric trichloride to sodium carbonate is 2: 1-3: 1. According to the method, actual production and the raw material ratio, material concentration, pH value, temperature and the like of a fixed reaction system are combined, the uniform adding speed of the sodium carbonate solution is controlled, and the ferric carboxymaltose with different target molecular weights is obtained. The method is simple, low in equipment and technical requirements and especially suitable for industrial operation and suitable for industrial production, and has great practical significance in actual production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical chemical industry, and relates to a method for preparing carboxymaltose iron, in particular to a method for controlling the molecular weight of carboxymaltose iron in the synthesis reaction of carboxymaltose iron, which is suitable for determining the molecular weight of the final product carboxymaltose iron in the synthesis process of carboxymaltose iron control. Background technique [0002] Iron-deficiency anemia is a common nutritional disease that occurs due to the inability of iron stores in the body to meet the needs of normal erythropoiesis. Carboxymaltose iron is a new type of drug for the treatment or prevention of iron deficiency anemia. [0003] The synthetic route of carboxyl maltose iron is as follows: [0004] [0005] Sodium hydroxide solution is used to control the pH of the maltodextrin solution at 9.0 to 11.0, with sodium bromide as the catalyst, the maltodextrin solution is m...

Claims

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Application Information

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IPC IPC(8): C08B37/00C08K3/22
CPCC08B37/00C08K3/22C08K2003/2265
Inventor 万辉黄春玉袁铎周红燕李剑徐向阳谢俊
Owner JINLING PHARMA
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