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Iron dextran and preparation method thereof

A technology for iron dextran and dextran, which is applied in the field of iron dextran and its preparation, can solve the problems of high macromolecular impurities and ionic impurities, low iron content, low solubility of iron dextran, etc., and achieves reduced content, high purity and good solubility. Effect

Active Publication Date: 2015-08-12
江西华太药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0009] The object of the present invention is to solve the problem that the solubility of iron dextran in cold water is less and iron content is on the low side, for improving its solubility in cold water, improve iron content, the present invention has taken following technology when complexing reaction finishes means:
[0011] The object of the present invention is also to solve the problem that molecular weight is 18-20 ten thousand macromolecular impurities and ion impurities in iron dextran, for this reason the present invention has taken following technical means before ultrafiltration:

Method used

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  • Iron dextran and preparation method thereof

Examples

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Embodiment 1

[0021] Embodiment 1: a kind of preparation method of iron dextran comprises the steps:

[0022] (1) Put 155kg of purified water into the reaction tank, control the pressure to 0.10 MPa, stir and heat to 80°C, then add 60kg of dextran 20, boil until completely dissolved; add 5.4mol / L hydrochloric acid to adjust the pH of the solution to 4, continue Boil for 1.5 hours, then cool to 38°C, add 10mol / L sodium hydroxide solution to adjust the pH of the hydrolyzate to 6, heat to 70°C, and pass through a 100-mesh sieve to obtain a brown-yellow transparent solution;

[0023] (2) Weigh 38.9kg of ferric chloride and dissolve it with 85kg of purified water, add it to the reaction tank, then add the prepared dextran 20 hydrolyzate, adjust the pH to 11 with 10mol / L sodium hydroxide solution, and control the pressure to 0.10MPa , the solution was heated to boiling, boiled for 1.5 hours, and then cooled to 38°C to obtain the complex solution; then technical means 1 was used for treatment, tha...

Embodiment 2

[0025] Embodiment 2: a kind of preparation method of iron dextran comprises the steps:

[0026] (1) Put 150kg of purified water into the reaction tank, control the pressure to 0.05MPa, stir and heat to 75°C, then add 60kg of dextran 20, boil until completely dissolved; add 5.4mol / L hydrochloric acid to adjust the pH of the solution to 3, continue Boil for 1 hour, then cool to 35°C, add 10mol / L sodium hydroxide solution to adjust the pH of the hydrolyzate to 6, heat to 65°C, and pass through a 100-mesh sieve to obtain a brown-yellow transparent solution;

[0027] (2) Weigh 38.9kg of ferric chloride and dissolve it with 80kg of purified water and add it to the reaction tank, then add the prepared dextran 20 hydrolyzate, adjust the pH to 10 with 10mol / L sodium hydroxide solution, and control the pressure to 0.05MPa , the solution was heated to boiling, boiled for 1 hour, and then cooled to 35°C to obtain the complex solution; then technical means 1 was used for treatment, that is...

Embodiment 3

[0029] Embodiment 3: a kind of preparation method of iron dextran comprises the steps:

[0030] (1) Put 160kg of purified water into the reaction tank, control the pressure to 0.15MPa, stir and heat to 85°C, then add 60kg of dextran 20, boil until completely dissolved; add 5.4mol / L hydrochloric acid to adjust the pH of the solution to 5, continue Boil for 2 hours, then cool to 40°C, add 10mol / L sodium hydroxide solution to adjust the pH of the hydrolyzate to 7, heat to 75°C, and pass through a 100-mesh sieve to obtain a brown-yellow transparent solution;

[0031] (2) Weigh 38.9kg of ferric chloride and dissolve it with 90kg of purified water, add it to the reaction tank, then add the prepared dextran 20 hydrolyzate, adjust the pH to 11 with 10mol / L sodium hydroxide solution, and control the pressure to 0.15MPa , the solution was heated to boiling, boiled for 2 hours, and then cooled to 40°C to obtain the complex solution; then technical means 1 was used for processing, that is...

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Abstract

The invention provides a preparation method of iron dextran. In the provided preparation method, after the complexing liquid is obtained, the pH of the complexing liquid is adjusted so as to greatly improve the dissolving property of iron dextran, while during the process, intermediates, which has a molecular weight of about 180000 to 200000, and accounts for 5 to 8% of the total weight of the final product, are generated, a great amount of ions absorbs on the intermediates, because the molecular weight of the intermediates is similar to that of iron dextran, the iron dextran and intermediates cannot be separated easily through ultrafiltration, thus the ion content of the final product is high, and the iron content is influenced in some degree, so a treatment is carried out before the ultrafiltration so as to remove the intermediates. The iron content of the prepared iron dextran is much higher than the national standard (25%), and can reach 40% or more. The solubility of iron dextran in cold water can reach 4g / 100g (cold water) or more, moreover, the contents of ions such as sodium iron, chlorine iron, and the like are greatly reduced, and the purity of iron dextran is higher.

Description

technical field [0001] The invention relates to an anti-anemia drug and a preparation method thereof, in particular to iron dextran and a preparation method thereof. Background technique [0002] Iron dextran, also known as iron dextran, is dark brown and can be sterilized by hot pressing and filtration; it is one of the important derivatives of low molecular weight dextran, which is the combination of dextran with a weight average molecular weight of 5000-7500 and iron hydroxide. complexes. Among them, iron ion is an effective active ingredient, which can be used to treat iron deficiency anemia, supplement the lack of iron in the patient's body, accelerate the synthesis of hemoglobin, and improve the symptoms related to tissue iron deficiency and iron-containing enzyme activity reduction. [0003] The method for preparing iron dextran is mainly to use dextran 20 for hydrolysis, and then carry out complexation reaction with ferric chloride. A certain traditional process fo...

Claims

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Application Information

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IPC IPC(8): C08B37/02A61P7/06
Inventor 裘德荣熊建国缪贵忠龚卫华王尽忠毛聪益
Owner 江西华太药业有限公司
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