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High-dissolution-rate sugar-iron compound and preparation method thereof

A compound and high solubility technology, which is applied in the direction of medical preparations, drug combinations, and pharmaceutical formulas of non-active ingredients, can solve the problems of increasing production costs, increasing the difficulty of powder crushing and energy input, etc., and achieves fast dissolution speed Effect

Active Publication Date: 2015-12-09
NANJING LIFENERGY R & D +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This will undoubtedly increase the difficulty of powder crushing and energy input, increasing production costs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Carboxy maltodextrin 1.88kg, ferric chloride 5.43kg, purified water 5.67kg, mix in the reaction kettle, control the temperature at 20-25°C, stir for 3h; Continue heating at ℃ for 5 hours to obtain a black colloidal solution formed by ferric hydroxide and polysaccharide; adjust the pH of the colloidal solution to 1.30 with hydrochloric acid solution, add 10.37kg of ethanol to obtain a sugar-iron complex, and dry to obtain a solid powder; the dried solid is pulverized by airflow Machine crushing, the crushing pressure is 0.7-0.75Mpa, and the frequency of the crushing wheel is 20Hz.

[0026] The results of product quality inspection after pulverization are as follows: iron content: 31.9%, sugar content: 30.1%, weight average molecular weight: 281256, pH1.49, specific surface area: 1.00, dissolution time: 8.0min. It can be seen that the pH is less than 2, and the dissolution rate is higher, but the molecular weight will exceed the upper limit of the molecular weight range i...

Embodiment 2

[0028] Carboxy maltodextrin 2.06kg, ferric chloride 5.43kg, purified water 5.67kg, mixed in the reaction kettle, temperature controlled 20-25 ℃, stirred for 3h; the solution was adjusted to pH 6.6 with 20% NaOH aqueous solution; the aqueous solution after alkali adjustment was 55 Continue heating at ℃ for 5 hours to obtain a black colloidal solution formed by ferric hydroxide and polysaccharide; adjust the pH of the colloidal solution to 2.0 with hydrochloric acid solution, add 9.68kg of ethanol to obtain a sugar-iron complex, and dry to obtain a solid powder; the dried solid is pulverized by airflow Machine crushing, the crushing pressure is 0.6-0.65Mpa, and the frequency of the crushing wheel is 11Hz.

[0029] The product quality inspection results after crushing are as follows: iron content: 30.1%, sugar content 32.5%, weight average molecular weight: 118023, pH2.01, specific surface area: 0.18m 2 / g, the dissolution time is 9.3min.

Embodiment 3

[0031] Carboxy maltodextrin 2.06kg, ferric chloride 5.43kg, purified water 5.67kg, mixed in the reaction kettle, temperature controlled 20-25°C, stirred for 3h; the solution was adjusted to pH 6.8 with 20% NaOH aqueous solution; the aqueous solution after alkali adjustment was 55 Continue heating at ℃ for 5 hours to obtain a black colloidal solution formed by ferric hydroxide and polysaccharide; adjust the pH of the colloidal solution to 2.1 with hydrochloric acid solution, add 13.56kg of ethanol to obtain a sugar-iron complex, and dry to obtain a solid powder; the dried solid is pulverized by airflow Machine crushing, the crushing pressure is 0.7-0.75Mpa, and the frequency of the crushing wheel is 30Hz.

[0032] The product quality inspection results after crushing are as follows: iron content: 29.5%, sugar content 33.3%, weight average molecular weight: 173258, pH2, specific surface area: 2.00m 2 / g, the dissolution time is 7.8min.

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PUM

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Abstract

The invention discloses a high-dissolution-rate sugar-iron compound and a preparation method thereof. The sugar-iron compound is a macromolecular compound formed by compounding of iron hydroxide and sugar, and complete dissolution time is shorter than 30 minutes. The sugar-iron compound is characterized in that (1) weight-average molecular weight is 10,000Da-230,000Da; (2) sugar content ranges from 25% to 50%; (3) iron content ranges from 24% to 32%; (4) a pH (potential of hydrogen) value ranges from 2 to 5. The high-dissolution-rate sugar-iron compound and the preparation method thereof have the advantages that studies discover that when the sugar content, the iron content, specific surface area and the pH value of the sugar-iron compound are controlled within a certain range, prepared active pharmaceutical ingredients of the sugar-iron compound are high in dissolution rate, and during preparation production, the technical difficulties that part of the active pharmaceutical ingredients are agglomerated at the bottom of a dosing tank, material liquid blocks a filter membrane and an injector and the like during dissolution can be avoided effectively.

Description

technical field [0001] The invention belongs to the field of pharmacy, and relates to a sugar-iron complex with a high dissolution rate and a preparation method thereof Background technique [0002] Iron is an essential trace element for the human body. Iron deficiency due to insufficient intake, limited utilization or other reasons is quite common. Iron deficiency anemia is the most widely distributed nutritional deficiency disease in the world today. Iron sugar-iron complex is currently widely used as an iron supplement for anti-iron deficiency anemia, especially for iron deficiency anemia caused by hemodialysis of kidney disease. It has the advantages of fast, efficient, accurate positioning, and low risk. [0003] Patent WO2007 / 081744 describes the preparation method and related pharmaceutical and chemical properties of sugar-iron complexes, such as iron carboxymaltose, but does not involve its dissolution properties, such as dissolution rate. [0004] But in fact, the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K33/26A61K47/48A61K47/02A61P7/06A61P3/02
Inventor 卢琴曹光龙汤传飞王宁方文
Owner NANJING LIFENERGY R & D