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Preparation method of ferric carboxymaltose injection

A technology of carboxymaltose iron and carboxymaltose, which is applied in the field of preparation of carboxymaltose iron injection, can solve problems such as the continuous production process of carboxymaltose iron that has not yet been seen, achieve solvent and energy saving, good economy, and simplify the refining and impurity removal process Effect

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

AI Technical Summary

Problems solved by technology

[0009] There is no relevant report on the continuous production process of iron carboxymaltose from synthesis to injection

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Add 1000mL of water to 500g of maltodextrin, stir to dissolve, add 30% sodium hydroxide solution to adjust the pH of the aqueous maltodextrin solution to 9.0-11.0, control the temperature at 25-40°C, add 400g of 10% sodium hypochlorite solution under stirring conditions, and obtain carboxyl malt Dextrin solution.

[0030] Carboxymaltodextrin solution and ferric chloride solution (ferric chloride hexahydrate 1100g, add water to prepare a 75% (w / w) solution) are first mixed, stirred, temperature controlled at 50-70°C, and uniformly speeded with a peristaltic pump Sodium carbonate solution (550 g of sodium carbonate, added with water to prepare a 25% (w / w) solution) was added dropwise, the flow rate was set, and the sodium carbonate solution was controlled to be added within about 1.0 hour. After finishing, add 30% sodium hydroxide solution to adjust the pH value of the solution to 10.0~12.0, control the temperature at 50~70°C, stir for 0.5 hour (alkali solidification); ad...

Embodiment 2

[0042] According to the technological process of embodiment 1, each material is amplified 2 times, obtains stable carboxyl maltose iron aqueous solution 12410g.

[0043] Regulate the pH value of carboxyl maltose ferric aqueous solution with 30% sodium hydroxide solution to be 6.4, under pressure 0.4~0.6Mpa, be the ceramic membrane filtration of 50nm with membrane aperture, measure the iron content of the solution that is intercepted by membrane with complexometric titration, Calculate the amount of water replenishment, add water to 31800mL, and retest the iron content to be 50.46mg / mL; then filter with a 0.22μm filter membrane, fill the filtrate into a 2mL ampoule, and sterilize.

[0044] According to the method of Example 1, the molecular weight and iron content of carboxymaltose iron in the carboxymaltose iron injection of this embodiment are shown in Table 1. The key indicators of this embodiment are consistent with those of the original preparation.

Embodiment 3

[0046] By the technological process of embodiment 1, each material is enlarged 4 times. Obtain 24350 g of stable carboxy maltose iron aqueous solution.

[0047] Regulate the pH value of carboxyl maltose ferric aqueous solution with 30% sodium hydroxide solution to be 6.3, under pressure 0.4~0.6Mpa, be the ceramic membrane filtration of 50nm with membrane aperture, measure the iron content of the solution that is intercepted by membrane with complexometric titration, Calculate the amount of water replenishment, add water to 64050mL, and retest the iron content to be 50.09mg / mL; then filter through a 0.22μm filter membrane, fill the filtrate into 2mL ampoules, and sterilize.

[0048] According to the method of Example 1, the molecular weight and iron content of carboxymaltose iron in the carboxymaltose iron injection of this embodiment are shown in Table 1. The key indicators of this embodiment are consistent with those of the original preparation.

[0049] Table 2: Key indica...

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Abstract

The preparation method comprises the following steps: by 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 aqueous solution; adjusting the pH value of the aqueous solution of ferric carboxymaltose to 5.0-7.0, filtering with a ceramic membrane, and supplementing water to the solution intercepted by the membrane until the iron content is 48-52 mg / mL; and filtering, filling and sterilizing. The preparation method of the ferric carboxymaltose injection is an integrated process, the refining and impurity removal process of the ferric carboxymaltose is simplified, the process from synthesis of the ferric carboxymaltose to completion of the injection is a continuous process, the processes of material refining, drying, packaging and the like are avoided in the process, a large amount of solvent and energy are saved, the economical efficiency is good, and the process is easy to implement in production and has higher practicability. The key indexes of the final product are consistent with those of an original sample.

Description

technical field [0001] The invention belongs to the field of drug synthesis and preparation technology, and relates to a preparation method of carboxymaltose iron injection. Background technique [0002] Iron deficiency anemia is a common nutritional disease and one of the nutritional deficiencies recognized worldwide. Iron deficiency anemia is anemia that occurs when iron stores in the body cannot meet the needs of normal red blood cell production. [0003] 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. [0004] 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, o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/716A61P7/06C08B37/16
CPCA61K9/08A61K9/0019A61K31/716A61P7/06C08B37/0012Y02P20/10
Inventor 万辉黄春玉袁铎李剑徐向阳谢俊
Owner JINLING PHARMA
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