Adhesive sodium hyaluronate gel for injection and preparation method thereof

A technology of sodium hyaluronate and hyaluronic acid, which is applied in prosthesis, medical science, etc., can solve the problems of weak affinity of sodium hyaluronate gel, and achieve the effect of strong binding force, easy injection, and short dialysis time

Active Publication Date: 2022-07-19
BLOOMAGE BIOTECHNOLOGY CORP LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to solve the problem of weak affinity between the above injection sodium hyaluronate gel and tissue, the application provides an injectable adhesive hyaluronic acid The sodium gel and its preparation method, compared with the sodium hyaluronate gel prepared by the traditional method, not only has good viscoelasticity, but also has excellent tissue adhesion, which can effectively prevent its displacement after injection into the body, and , the sodium hyaluronate gel for injection prepared by the method of the present application still maintains good biocompatibility

Method used

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  • Adhesive sodium hyaluronate gel for injection and preparation method thereof
  • Adhesive sodium hyaluronate gel for injection and preparation method thereof
  • Adhesive sodium hyaluronate gel for injection and preparation method thereof

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preparation example Construction

[0035] On the one hand, the application provides a kind of preparation method of adhesive sodium hyaluronate gel for injection, it is characterized in that, it comprises the following steps:

[0036] Synthesize cross-linking agent A: Synthesize cross-linking agent A containing disulfide bonds;

[0037] Cross-linking: The gel L is obtained by reacting sodium hyaluronate with the cross-linking agent A and the cross-linking agent B;

[0038] Preparation of Gel M: Gel M is obtained by treating the Gel L with glutathione;

[0039] Treatment of Gel M: Gel M is dialyzed to obtain the adhesive sodium hyaluronate gel for injection.

[0040] "Glutathione" (GSH) in this application is a tripeptide containing a gamma-amide bond and a sulfhydryl group, consisting of glutamic acid, cysteine ​​and glycine, present in almost every cell of the body. Glutathione helps maintain normal immune system function and has antioxidant, integrated detoxification properties. The sulfhydryl group on cys...

Embodiment 1

[0077] (1) Mix 0.042mol cystine and 0.084mol 1,4-butanediol diglycidyl ether in 100mL, 0.1mol / L NaOH solution, stir and react in a water bath at 20°C for 8 hours, separate and purify to obtain 0.035mol containing Disulfide Epoxy Crosslinker A

[0078]

[0079] (2) Dissolve 939.0 g of sodium hyaluronate (molecular weight 800 kDa, the amount of sodium hyaluronate repeating unit is 2.33 mol) in 100 mL of NaOH solution with a mass fraction of 1.5%, stir and dissolve to obtain sodium hyaluronate solution, the cross-linking agent A and BDDE are mixed and added to the sodium hyaluronate solution, and the cross-linking reaction is carried out at 30 ° C for 8 hours to obtain a cross-linked gel L, wherein the amount of the cross-linking agent A and BDDE is The ratio is 0.5:1, and the ratio of the amount of the total substance of the cross-linking agent A and BDDE to the amount of the substance of the sodium hyaluronate repeating unit is 0.045:1;

[0080] (3) the gel L obtained in st...

Embodiment 2

[0085] (1) Mix 0.042mol cystine and 0.084mol 1,4-butanediol diglycidyl ether in 100mL, 0.1mol / L NaOH solution, stir and react in a water bath at 10°C for 8 hours, separate and purify to obtain 0.035mol containing Disulfide Epoxy Crosslinker A

[0086]

[0087] (2) Dissolve 471.5g sodium hyaluronate (molecular weight 300kDa, the amount of sodium hyaluronate repeating unit is 1.17mol) in 100mL, 1.5% NaOH solution, stir and dissolve to obtain a sodium hyaluronate solution, put The cross-linking agent A and BDDE are mixed and added to the sodium hyaluronate solution, and the cross-linking reaction is carried out at 25 ° C for 8 hours to obtain the cross-linked gel L. The ratio of the amount of the cross-linking agent A to the BDDE is 1:1, the ratio of the total amount of the crosslinking agent A and BDDE to the amount of the sodium hyaluronate repeating unit is 0.06:1;

[0088] (3) the gel L obtained in step (2) is broken by mechanical force, and crossed through a 60-mesh siev...

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Abstract

The invention discloses a preparation method of adhesive sodium hyaluronate gel for injection. The preparation method comprises the following steps: synthesizing a cross-linking agent A: synthesizing the cross-linking agent A containing disulfide bonds; cross-linking: reacting sodium hyaluronate with a cross-linking agent A and a cross-linking agent B to obtain gel L; preparing gel M: treating the gel L by using glutathione to obtain the gel M; treating the gel M: dialyzing the gel M to obtain the adhesive sodium hyaluronate gel for injection. The invention also discloses the adhesive sodium hyaluronate gel for injection prepared by the preparation method. The invention further discloses adhesive sodium hyaluronate gel for injection, the adhesive sodium hyaluronate gel comprises the compound with the structure shown in the formula (I), and n is 744-1985. The adhesive sodium hyaluronate gel for injection provided by the invention has good mechanical properties, is easy to inject, has strong binding force with tissues, does not generate obvious displacement in the tissues, and has good biocompatibility. The sodium hyaluronate gel disclosed by the invention is simple in preparation process, short in dialysis time, low in energy consumption and free of by-products.

Description

technical field [0001] The present application belongs to the technical field of cross-linked hyaluronic acid. Specifically, it relates to an adhesive sodium hyaluronate gel for injection and a preparation method thereof. Background technique [0002] Hyaluronic acid is a natural macromolecular polysaccharide, which is one of the components of the extracellular matrix. It has excellent biocompatibility and good moisturizing properties. It is known as an excellent natural moisturizing factor and has been widely used in medical beauty, tissue engineering, regenerative medicine, and medical devices. At present, sodium hyaluronate gel for injection is mostly sodium hyaluronate gel with BDDE as the cross-linking agent. The cross-linking process using BEED is simple, suitable for industrial production, and the metabolic pathway in vivo is clear and safe, so it is widely used. [0003] The currently used sodium hyaluronate gel for injection is mainly a gel obtained by cross-linki...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/50A61L27/52A61L27/20C08J3/24C08L5/08
CPCA61L27/50A61L27/52A61L27/20C08J3/24A61L2400/06C08J2305/08C08L5/08
Inventor 房浩伟张晓鸥郭学平
Owner BLOOMAGE BIOTECHNOLOGY CORP LTD
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