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Preparation process of ferric carboxymaltose injection

A carboxymaltose iron and preparation process technology, which is applied in the direction of medical preparations containing active ingredients, blood diseases, extracellular fluid diseases, etc., can solve the unseen continuous production process of carboxymaltose iron, the influence of carboxymaltose iron molecular weight, and large consumption Solvent and energy problems, to achieve the effect of saving solvent and energy, easy to realize, and high practicability

Active Publication Date: 2021-06-25
JINLING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These processes such as refining and drying will have an impact on the molecular weight of carboxymaltose iron, and will consume a large amount of solvent and energy, and the economy is poor
[0008] There is no relevant report on the continuous production process of carboxymaltose iron from synthesis to injection

Method used

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  • Preparation process of ferric carboxymaltose injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Add 200 mL of water to 100 g of maltodextrin and stir to dissolve; add 30% sodium hydroxide solution to adjust the pH of the maltodextrin aqueous solution to 9.0-11.0, control the temperature at 25-40°C, and add 80 g of 10% sodium hypochlorite solution under stirring to obtain carboxylated malt Dextrin solution.

[0025] Preparation of ferric chloride solution: 220 g of ferric chloride hexahydrate was mixed with water to form a 75% (w / w) solution.

[0026] Preparation of sodium carbonate solution: add 110 g of sodium carbonate to prepare a 25% (w / w) solution.

[0027] The carboxy maltodextrin solution and the ferric chloride solution are first mixed, stirred, the temperature is controlled at 50-70°C, the flow rate is set, and the sodium carbonate solution is added dropwise at a constant speed with a peristaltic pump, and the sodium carbonate solution is controlled to be added within 1.0 hour. After completion, carry out alkali curing, acid curing and high temperature c...

Embodiment 2

[0039] According to the technical process of Example 1, each material was enlarged by 2 times to obtain a stable iron carboxy maltose solution.

[0040] Add 320 g of absolute ethanol to carboxymaltose iron solution to precipitate carboxymaltose iron, filter, add 1200 mL of water for injection to the filter cake, stir to dissolve, adjust the pH value to 6.5 with 30% sodium hydroxide solution, and measure iron by complexometric titration content, calculate the amount of water replenishment, add water to 1866mL, and retest the iron content to be 49.12mg / mL; then filter through a 0.22μm filter membrane, fill the filtrate into 2mL ampoules, and sterilize.

[0041] According to the method of Example 1, the molecular weight and iron content of carboxymaltose iron in the present embodiment carboxymaltose iron injection were determined. See Table 1, the key indicators of this embodiment are consistent with those of the original preparation.

Embodiment 3

[0043] According to the technical process of Example 1, each material was enlarged 4 times to obtain a stable iron carboxy maltose solution.

[0044] Add 640g of absolute ethanol to carboxymaltose iron solution to precipitate carboxymaltose iron, filter, add 2400mL of injection to the filter cake, stir to dissolve, adjust the pH value to 6.3 with 30% sodium hydroxide solution, and use complexometric titration to measure iron content, calculate the amount of water replenishment, add water to 3629mL, and retest the iron content to 50.32mg / mL; then filter through a 0.22μm filter membrane, fill the filtrate into 2mL ampoules, and sterilize.

[0045] According to the method of Example 1, the molecular weight and iron content of carboxymaltose iron in the present embodiment carboxymaltose iron injection were determined. See Table 1, the key indicators of this embodiment are consistent with those of the original preparation.

[0046] Table 1: Key indicators of embodiment 1-embodimen...

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Abstract

The invention relates to a preparation process of ferric carboxymaltose injection, which comprises the following steps: taking maltodextrin as an initial reaction raw material, oxidizing the maltodextrin with sodium hypochlorite to generate carboxyl maltodextrin, and complexing the carboxyl maltodextrin with a ferric trichloride solution to obtain a ferric carboxymaltose solution; adding absolute ethyl alcohol into the ferric carboxymaltose solution, separating out ferric carboxymaltose, and filtering; wherein a filter cake does not need to be dried, directly adding water for dissolution, and adjusting the pH to 5.0-7.0; supplementing water until the iron content is 48-52 mg / mL; and filtering, filling and sterilizing. The key indexes of the product prepared by the method are consistent with those of an original product, but the process from synthesis of ferric carboxymaltose to completion of the injection is a continuous process, the processes of refining, drying, packaging and the like of materials are avoided in the process, and other organic solvents are not involved except that ethanol is used for separating out ferric carboxymaltose from an aqueous solution of ferric carboxymaltose, a large amount of solvent and energy are saved, the economical efficiency is good, the process is easy to implement in production, and the practicability is high.

Description

technical field [0001] The invention belongs to the field of medicine synthesis and preparation technology, and relates to a preparation technology of carboxymaltose iron injection. Background technique [0002] At present, about 2 billion people in the world suffer from anemia, and from the clinical statistics, more than 90% of them are iron-deficiency anemia; that is to say, 9 out of 10 anemia patients are iron-deficiency anemia patients. 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. [0003] The most common treatment for iron deficiency anemia is oral or injectable iron. Oral iron supplementation is effective, cheap and safe, and is now often used as the drug of choice for iron deficiency anemia, and oral iron supplementation is still the mainstay in China. However, oral iron often has obvious symptoms of gastrointestinal discomfort, and some patients interru...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/716A61P7/06C08B31/00
CPCA61K9/08A61K9/0019A61K31/716A61P7/06C08B31/00
Inventor 万辉黄春玉袁铎李剑徐向阳谢俊
Owner JINLING PHARMA
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