Method for removing endotoxin in oligomeric sodium hyaluronate

A technology of oligomeric hyaluronic acid and sodium hyaluronate, applied in the field of biomedicine, can solve the problems of high cost, residual detergent, long time, etc., and achieve the effects of low pollution risk, thorough removal and low cost

Active Publication Date: 2019-11-08
河北常山凯络尼特生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Existing endotoxin removal methods mainly include liquid phase separation, activated carbon adsorption, quaternary ammonium salts drug removal, and ultrafiltration, but these endotoxin removal methods have problems such as incomplete treatment, long time and high cost.
[0004] The liquid phase separation method uses some detergents, such as Triton-114. Sodium deoxycholate can combine with the lipid part of endotoxin to remove endotoxin by extraction, but there will be detergent residue in the removed product, which is not Conform to medical grade quality requirements of oligomeric sodium hyaluronate
Activated carbon uses the gaps to absorb impurities and remove endotoxins at the same time. However, due to the limitation of pore size, the endotoxin removal effect in general oligomeric hyaluronic acid is 0.5 EU/mg, which is ten times greater

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] A method for removing endotoxin in oligomeric sodium hyaluronate, comprising the following steps carried out in sequence:

[0027] (1) Endotoxin detection: the endotoxin content in the oligomeric sodium hyaluronate powder is detected to be less than 5 EU / mg by using the limulus reagent;

[0028] (2) Dissolve the oligomeric sodium hyaluronate powder in a certain volume of water for injection that has been tested and meets the endotoxin detection standard, the concentration is 8%, and stir at room temperature to completely dissolve it;

[0029] (3) Add sodium hydroxide and sodium chloride solids respectively, so that the final concentration of sodium hydroxide is 0.5%, and the final concentration of sodium chloride is 5%, and stir at room temperature for 8 hours;

[0030] (4) Adjust the pH of the solution to neutral with glacial acetic acid;

[0031] (4-1) Endotoxin re-testing: take a sample of the solution, and use the Limulus reagent to detect the endotoxin content of ...

Embodiment 2

[0034] A method for removing endotoxin in oligomeric sodium hyaluronate, comprising the following steps carried out in sequence:

[0035] (1) Endotoxin detection: the endotoxin content in the oligomeric sodium hyaluronate powder is detected to be less than 5 EU / mg by using the limulus reagent;

[0036] (2) Dissolve the oligomeric sodium hyaluronate powder in a certain volume of water for injection that has been tested and meets the endotoxin detection standard, the concentration is 10%, and stir at room temperature to completely dissolve;

[0037] (3) Add sodium hydroxide and sodium chloride solids respectively, so that the final concentration of sodium hydroxide is 0.5%, and the final concentration of sodium chloride is 5%, and stir at room temperature for 8 hours;

[0038] (4) Adjust the pH of the solution to neutral with glacial acetic acid;

[0039] (4-1) Retesting of endotoxin: take a sample of the solution, and use the limulus reagent to detect that the endotoxin conten...

Embodiment 3

[0042] A method for removing endotoxin in oligomeric sodium hyaluronate, comprising the following steps carried out in sequence:

[0043] (1) Endotoxin detection: the endotoxin content in the oligomeric sodium hyaluronate powder is detected to be less than 5 EU / mg by using the limulus reagent;

[0044] (2) Dissolve the oligomeric sodium hyaluronate powder in a certain volume of water for injection that has been tested and meets the endotoxin detection standard, the concentration is 10%, and stir at room temperature to completely dissolve;

[0045] (3) Add sodium hydroxide and sodium chloride solids respectively, so that the final concentration of sodium hydroxide is 5%, and the final concentration of sodium chloride is 5%, and stir at room temperature for 8 hours;

[0046] (4) Adjust the pH of the solution to neutral with glacial acetic acid;

[0047](4-1) Endotoxin re-testing: take a sample of the solution, and use the Limulus reagent to detect the endotoxin content of the o...

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PUM

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Abstract

The invention discloses a method for removing endotoxin in oligomeric sodium hyaluronate, and the method comprises the following steps in sequence: (1) performing raw material endotoxin limit detection; (2) dissolving the oligomeric sodium hyaluronate in water; (3) respectively adding a sodium hydroxide solid and a sodium chloride solid, and stirring; (4) adjusting the pH of the solution to neutrality; and (5) adding ethanol for precipitation, dewatering and drying to obtain oligomeric sodium hyaluronate powder. The method has the advantages of thorough treatment, simple steps and low cost, and the endotoxin content of the treated oligomeric sodium hyaluronate reaches the medical standard (less than 0.05 EU/mg).

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a method for removing endotoxin in oligomeric sodium hyaluronate. Background technique [0002] Oligomeric sodium hyaluronate is a molecular fragment of sodium hyaluronate with a very low molecular weight prepared by the degradation of hyaluronic acid, and is an inherent component in the human body. It has strong skin permeability and can penetrate into the cutin of the skin. At the same time, it has all-round moisturizing and anti-aging properties, and has a wide range of applications in the field of cosmetics. The injection oligomeric sodium hyaluronate is more easily absorbed than sodium hyaluronate, and can be used for injection repair of bone and joint trauma and wrinkle removal. [0003] Endotoxin is a substance released by Gram-negative bacteria, and the human body is extremely sensitive to endotoxin. Endotoxin can cause fever, microcirculation disturbance...

Claims

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Application Information

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IPC IPC(8): C08B37/08
CPCC08B37/0003C08B37/0072
Inventor 薛茹刘振姚圣圣
Owner 河北常山凯络尼特生物技术有限公司
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