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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  • 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

Method used

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

Examples

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Example Embodiment

[0035] Example 1

[0036] The maltodextrin is 100g, and 200ml of water is added to stir the dissolved, 1 g of bromide is added, and the pH of the hydroxide solution to adjust the maltodextrin solution is 9.0 ~ 11.0, temperature control 25 to 40 ° C, stirring, 10% sodium hypochlorite under stirring. The solution was 80 g, and the carboxyl maltode was obtained.

[0037] Carboxymethemus erythrochemical solution with trichloride solution (trichloride concentration 75% w / w, 220 g of iron chloride hexahydrate 220g] is made into first mix, stir, temperature control 50 ~ 70 ° C, with peristalsis The pump was pumped, and the sodium carbonate solution was pumped (concentration 25% w / w, was formulated from 110 g of sodium carbonate), and the flow rate and sodium carbonate were added to 0.3 hours. After the reaction is completed, a 30% sodium hydroxide solution is added, and the pH of the solution is 10.0 to 12.0, the temperature control is 50 to 70 ° C, stirred for 0.5 hours (base curing...

Example Embodiment

[0038] Example 2

[0039] Preparation of Carboxymethum Malt Quick Solution As Example 1.

[0040] Carboxymetallucetux (((((((,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, (,, The peristaltic pump is allowed to add sodium carbonate solution (concentration 25% w / w, 10 g of sodium carbonate), set the flow rate, sodium carbonate solution to 0.5 hours. After the reaction is completed, the acid, base and high temperature are solidified. A stable carboxy maltose iron solution was obtained, and then anhydrous ethanol 160 ml was added to precipitate the carboxyl maltose.

Example Embodiment

[0041] Example 3

[0042] Preparation of Carboxymethum Malt Quick Solution As Example 1.

[0043]Carboxymethemus erythrochemical solution with trichloride solution (trichloride concentration 75% w / w, 220 g of iron chloride hexahydrate 220g] is made into first mix, stir, temperature control 50 ~ 70 ° C, with peristalsis The pump was pumped, and the sodium carbonate solution was pumped (concentration 25% w / w, and the water was prepared from 110 g of sodium carbonate), and the flow rate, sodium carbonate solution was added over 1.0 hours. After the reaction was completed, a stable carboxyl maltose iron solution was obtained after the acid, base and high temperature was cured, and then anhydrous ethanol 160 ml was added to precipitate the carboxyl 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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