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Preparation method of low-temperature secondary cross-linked sodium hyaluronate gel

A technology of cross-linking hyaluronic acid and sodium hyaluronate, which is applied in the field of medical biomaterials and industrial transformation, to improve cross-linking efficiency, reduce the generation of organic reaction by-products, and improve biocompatibility

Inactive Publication Date: 2013-06-12
SHANGHAI QISHENG BIOLOGICAL PREPARATION CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] To sum up, in order to obtain a safe and effective BDDE cross-linked sodium hyaluronate product, the above two important problems need to be solved at the same time, that is, to effectively remove the cross-linking agent residue of BDDE and improve the biocompatibility of the product. None of the domestic invention patents involve

Method used

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  • Preparation method of low-temperature secondary cross-linked sodium hyaluronate gel
  • Preparation method of low-temperature secondary cross-linked sodium hyaluronate gel

Examples

Experimental program
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Effect test

Embodiment 1

[0011] Prepare 20 ml of 1% sodium hydroxide aqueous solution, add 0.2 g of cross-linking agent BDDE, mix well, add 2.0 g of sodium hyaluronate, stir well, put it in a refrigerator at 4° C. for 48 hours. Then, put it in a 40°C water bath, heat for 2 hours, take out the gel cut into about 1 g in mass, put it in PBS buffer solution, and perform expansion dialysis for 8 hours to obtain a cross-linked sodium hyaluronate gel with a concentration of 20 mg / ml .

Embodiment 2

[0013] Prepare 20ml of 1% sodium hydroxide aqueous solution, add 0.1g of cross-linking agent BDDE, mix well, add 2.0g sodium hyaluronate, stir well, put it in a refrigerator at 6°C for 48h. Then, put it in a 40°C water bath, heat for 2 hours, take out the gel cut into about 1 g in mass, put it in PBS buffer solution, and perform expansion dialysis for 8 hours to obtain a cross-linked sodium hyaluronate gel with a concentration of 20 mg / ml .

Embodiment 3

[0015] Prepare 10ml of 1.5% sodium hydroxide aqueous solution, add 0.08g of cross-linking agent BDDE, mix well, add 1.5g of sodium hyaluronate, stir well, put it in a refrigerator at 4°C for 24h. Then, put it in a water bath at 50°C, heat it for 1 hour, take out the gel cut into a mass of about 1 g, put it in PBS buffer solution, and perform expansion dialysis for 10 hours to obtain a cross-linked sodium hyaluronate gel with a concentration of 20 mg / ml .

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Abstract

The invention relates to a preparation method of 1,4-butanediol diglycidyl ether cross-linked sodium hyaluronate gel. The method comprises the steps of: by taking high-concentration sodium hyaluronate solution as reaction matrix, performing first cross-linking for a longer time under the low-temperature condition by adding less cross-linking agent, then performing secondary deep cross-linking under high-temperature condition, and finally processing and pelleting through short-time dialysis technique, thereby obtaining the sodium hyaluronate gel product. With the method, the cross-linking condition of the high-concentration cross-linking agent under the traditional high-temperature condition can be eliminated, milder secondary depth cross-linking condition is adopted, the reaction efficiency of the less cross-linking agent can be greatly improved, the residual cross-linking agent is more easily removed, and the excellent biocompatibility of the cross-linked sodium hyaluronate gel can be ensured. The method is simple in preparation technique, excellent in controllability and easier to practically produce on large scale.

Description

technical field [0001] The invention relates to the technical field of medical biological materials and industrial transformation, and relates to a preparation method of a novel cross-linked sodium hyaluronate, which is used for medical filling and cosmetology. Background technique [0002] Sodium hyaluronate is an important component of human and animal skin, vitreous, joint lubricating fluid and cartilage tissue, which consists of (1-β-4)D-glucuronic acid and (1-β-3)N-acetyl- D-Glucosamine disaccharide units are repeatedly connected, and are widely used in repair surgery, eye surgery or as cosmetic products to fill wrinkles. Hyaluronic acid has good physical and chemical properties and biocompatibility. However, it is rapidly degraded by the enzymatic hydrolysis of hyaluronidase in the body, and its retention time is short, requiring repeated injections to achieve curative effect. Cross-linked hyaluronic acid is a polymer gel with a three-dimensional structure obtained b...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08J3/24C08J3/075C08L5/08C08K5/1515A61L27/20A61L27/52
Inventor 魏长征奚宏伟朱彬蒋丽霞吴剑英王文斌
Owner SHANGHAI QISHENG BIOLOGICAL PREPARATION CO LTD
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