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Synthesis method of iron dextran and dispersible tablet thereof

A technology of iron dextran and dextran, which is applied in the field of preparation of anti-anemia drugs, can solve the problems of low dissolution rate, low iron content, and low production efficiency, so as to reduce iron ion precipitation, increase iron content and dissolution rate, Effect of improving dissolution rate

Active Publication Date: 2022-03-25
江西华太药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] At present, there are two problems in the synthesis method of iron dextran. On the one hand, there are generally problems such as low iron content, low dissolution rate, and high impurity content; Bring difficulty, resulting in low production efficiency

Method used

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  • Synthesis method of iron dextran and dispersible tablet thereof
  • Synthesis method of iron dextran and dispersible tablet thereof
  • Synthesis method of iron dextran and dispersible tablet thereof

Examples

Experimental program
Comparison scheme
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Embodiment 1

[0049] The present embodiment provides a kind of synthetic method of iron dextran, comprises the following steps:

[0050] (1) Make dextran 20 in pure water to make dextran hydrolyzate, weigh ferric chloride, and dissolve it with 2 times the amount of pure water to make ferric chloride solution, wherein the mass of dextran 20 and ferric chloride The ratio is 1:2.5;

[0051] (2) Add the dextran hydrolyzate and ferric chloride solution into the reaction tank and mix evenly, adjust the pH of the obtained reaction solution to 10, then heat it to boiling under 0.08MPa, and react for 50 minutes to obtain the complex solution ;

[0052] (3) Adjust the pH of the obtained complex solution to 6.3 with hydrochloric acid solution, then pass through coarse filtration, medium filtration and ultrafiltration respectively, and spray dry to obtain the finished product of iron dextran.

[0053] This embodiment also provides a dispersible tablet of iron dextran synthesized according to the abov...

Embodiment 2

[0057] On the basis of Example 1, this example also provides a method for synthesizing iron dextran, wherein the preparation method of step (1) dextran hydrolyzate is:

[0058] Heat the purified water to 80°C, then add dextran 20 and stir to dissolve to obtain a dextran solution, then heat to boiling, add hydrochloric acid solution to adjust the pH of the dextran solution to 4, keep boiling for 1 hour, then cool to 30°C, and then adjust the pH of the dextran solution to 7.2 , to obtain dextran hydrolyzate.

[0059] Among them, the mass ratio of dextran 20 to purified water is 1:5, the concentration of hydrochloric acid solution is 5 mol / L, and the concentration of sodium hydroxide solution is 9 mol / L.

[0060] The specific method for adjusting the pH of the dextran solution to 7.2 is:

[0061] A. Take anhydrous sodium carbonate and pure water according to the mass ratio of 1:2 to prepare sodium carbonate solution, then take anhydrous sodium bicarbonate and pure water accordin...

Embodiment 3

[0065] On the basis of Example 1, this example also provides a method for synthesizing iron dextran, wherein the specific method for adjusting the pH of the reaction solution to 10 in step (2) is:

[0066] a. Take anhydrous sodium carbonate and pure water according to the mass ratio of 1:3.5 to prepare the first sodium carbonate solution, then take anhydrous sodium carbonate and pure water according to the mass ratio of 1:2 to prepare the second sodium carbonate solution ;

[0067] B, drip the first part of sodium carbonate solution in the reaction solution under stirring conditions, until the pH of the solution is 3, then continue to drop the second part of sodium carbonate solution until the pH of the solution is 4, continue to stir for 50-60min, Then sodium hydroxide solution was added dropwise until the pH of the solution was 10.

[0068] All the other are with embodiment 1.

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Abstract

The invention discloses a method for synthesizing iron dextran and its dispersible tablets, comprising the following steps: (1) preparing dextran 20 into a dextran hydrolyzate, weighing ferric chloride to prepare a ferric chloride solution; (2) preparing the dextran Add the hydrolyzate and ferric chloride solution into the reaction tank and mix evenly, adjust the pH of the obtained reaction solution to 10‑11, then heat to boiling state, and react to obtain the complex solution; (3) the obtained complex solution The pH of the solution is adjusted to 6.3-6.8 with hydrochloric acid solution, and then the finished product of iron dextran is obtained after being subjected to coarse filtration, medium filtration and ultrafiltration, and spray drying. The invention provides a method for synthesizing iron dextran and its dispersible tablets. Through the pH value adjustment before and after the complexation reaction and the design of the ceramic ultrafiltration membrane, the iron content and dissolution rate can be increased, the impurity content can be reduced, and the production efficiency can also be improved.

Description

technical field [0001] The invention belongs to the technical field of preparation of anti-anemia drugs, and more specifically relates to a method for synthesizing iron dextran and dispersible tablets thereof. Background technique [0002] Iron-deficiency anemia is the most common type of anemia. Iron deficiency anemia can be caused by insufficient iron intake, impaired iron absorption, or excessive iron loss due to increased iron content. Patients may have fatigue, tiredness, dizziness, and growth retardation in children. , Mental retardation, its incidence is significantly higher in developing countries, economically underdeveloped areas, infants, and women of childbearing age. Iron dextran can also be used as a drug for preventing and treating iron deficiency anemia in piglets. [0003] Iron dextran, also known as iron dextran complex, iron dextran, iron dextran, is a complex of dextran and iron with a weight average molecular weight (Mw) of 5000-7500, generally containi...

Claims

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Application Information

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IPC IPC(8): C08B37/02A61K31/721A61K33/26A61K9/30A61P7/06
CPCC08B37/0021A61K9/282A61K31/721A61P7/06A61K33/26
Inventor 缪贵忠刘慧星裘德荣熊建国龚卫华王尽忠毛聪益
Owner 江西华太药业有限公司
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