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A kind of stable sugar-iron complex and preparation method thereof

A compound and iron content technology, applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, drug combinations, etc., can solve problems such as being in the blank, achieve good stability, improve iron utilization, The effect of reducing adverse reactions

Active Publication Date: 2018-05-18
NANJING LIFENERGY R & D +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] So far, the instability of cross-linked flocculation of carboxymaltose-iron complexes still exists
And there is no literature that has noticed the risk of cross-linking and flocculation of carboxymaltose-iron complexes
At present, the research on cross-linking and flocculation of carboxymaltose-iron complex is still blank

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Add 1.5kg carboxymaltodextrin, 2.9kg ferric chloride and 6kg purified water into the reaction kettle, adjust the pH of the solution to 6.55 with 20% aqueous sodium hydroxide solution, and heat it to 50°C for 5 hours to obtain a black or dark brown colloid solution. Cool the reaction liquid to below 35°C, add 4.8kg of ethanol, ethanol analysis to obtain a wet product of carboxymaltose iron complex, and dry and pulverize the wet product to obtain carboxymaltose iron powder.

[0030] Determine the total sugar content, free sugar content, iron content and molecular weight of the sample, and prepare the sample into a 50 mg iron / ml sugar-iron complex solution, adjust the pH to 5-7, and leave it at room temperature for 24 hours to observe the stability of the sample.

[0031] Sample test results: total sugar 40.7%, iron content 27.2%, sugar iron ratio 1.5:1, free sugar 12.0%, molecular weight 152870Da. The complex solution was left at room temperature for 24 hours without pre...

Embodiment 2

[0033] Add 1.5kg carboxymaltodextrin, 2.9kg ferric chloride and 6kg purified water into the reaction kettle, adjust the pH of the solution to 8.60 with 20% aqueous sodium hydroxide solution, heat to 45°C for 5 hours, and obtain a black or dark brown colloid solution. Cool the reaction liquid to below 35°C, add 3kg of ethanol, ethanol analysis to obtain a wet product of carboxymaltose iron complex, and dry and pulverize the wet product to obtain carboxymaltose iron powder.

[0034] Determine the total sugar content, free sugar content, iron content and molecular weight of the sample, and prepare the sample into a 50 mg iron / ml sugar-iron complex solution, adjust the pH to 5-7, and leave it at room temperature for 24 hours to observe the stability of the sample.

[0035] Sample test results: total sugar 41.0%, iron content 28.2%, sugar-iron ratio 1.5:1, free sugar 1.5%, molecular weight 188050Da. The complex solution was left at room temperature for 24 hours without precipitati...

Embodiment 3

[0037] Add 1.5kg carboxymaltodextrin, 2.9kg ferric chloride and 6kg purified water into the reaction kettle, adjust the pH of the solution to 9.95 with 20% aqueous sodium hydroxide solution, heat to 55°C for 5 hours, and obtain a black or dark brown colloid solution. Cool the reaction liquid to below 35°C, add 4.2kg of ethanol, ethanol analysis to obtain a wet product of carboxymaltose iron complex, and dry and pulverize the wet product to obtain carboxymaltose iron powder.

[0038] Determine the total sugar content, free sugar content, iron content and molecular weight of the sample, and prepare the sample into a 50 mg iron / ml sugar-iron complex solution, adjust the pH to 5-7, and leave it at room temperature for 24 hours to observe the stability of the sample.

[0039] Sample test results: total sugar 40.9%, iron content 27.5%, sugar iron ratio 1.5:1, free sugar 6.4%, molecular weight 176520Da. The complex solution was left at room temperature for 24 hours without precipita...

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Abstract

The invention discloses a stable sugar-iron complex and a preparation method thereof. The sugar-iron complex contains a ferric hydroxide carboxymaltose complex. The ratio of the iron content to the total sugar content in the sugar-iron complex is 1:0.8 to 1:2.0; and the free sugar content is not less than 1.0% of the total sugar content. Sugar-iron complexes within this range have better stability. The sugar-iron complex overcomes the shortcoming of the instability of the sugar-iron complex prepared by the existing synthetic method, so that the injection does not produce precipitation or gelation during storage, thereby reducing the need for treatment of iron deficiency. The adverse reactions of patients in diseases such as sexual anemia can be improved, and the utilization rate of iron can be improved.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to a stable sugar-iron complex and a preparation method thereof. Background technique [0002] Iron is an essential trace element for the human body. The treatment of iron deficiency is very necessary for patients with iron deficiency anemia. Intravenous injection of iron is an effective means for the treatment of various iron deficiency diseases, such as severe iron deficiency anemia, intestinal Iron malabsorption, enteral iron intolerance, iron deficiency disease in whom oral administration does not respond (e.g. in dialysis patients). [0003] Sugar-iron complex is currently widely used as an anti-iron deficiency anemia iron supplement, especially for iron deficiency anemia caused by hemodialysis of kidney disease. It has the advantages of fast, efficient, accurate positioning, and low risk. [0004] By an unexpected chance, we found that some sugar-iron complexes, such as iron carboxymalto...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/295A61K33/26A61K47/26A61K47/61A61K47/54A61P3/02A61P7/06
Inventor 秦红星胡良明刘勇沙伟方文
Owner NANJING LIFENERGY R & D
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