Method for preparing medical cross-linking sodium hyaluronate gel

A technology of cross-linking hyaluronic acid and sodium hyaluronate, which is applied in the fields of medical science and prosthesis, and can solve problems such as difficult removal, ineffective removal or reduction of cross-linking agent content, and lower injectability

Inactive Publication Date: 2014-11-19
吴学森
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the amount of cross-linking agent is high, the residence time in the body will be prolonged accordingly, but the hardness will increase and the injectability will decrease. At the same time, excess cross-linking agent will remain in the product, and it is difficult to purify and clean
Moreover, removing the cross-linking agent in the gel product is also a big problem at present. The most commonly used methods to remove or reduce the residual cross-linking agent include dialysis or washing with water or buffer solution, but these methods cannot effectively remove or reduce The content of cross-linking agent is low, and the cycle is long, so it is not easy to realize industrial production
Another kind, if it is to prepare cross-linked hyaluronic acid solids, the commonly used method to remo

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Take 7.0ml of aqueous sodium hydroxide solution with a concentration of 0.25M and 50μL of crosslinking agent 1,4-butanediol diglycidyl ether, mix the two evenly, and add sodium hyaluronate 1.0 with an average molecular weight of 1.7 million under magnetic stirring. g, after stirring for 5 minutes, put it in a constant temperature water bath at 40°C for 3 hours, then react at 25°C for 3 days, after the reaction, add 100mL of 0.1M phosphate buffer solution with a pH of 7.0 to the obtained product and soak and wash repeatedly In order to obtain a pH<7.5 and a physiologically acceptable osmotic pressure value, drain the water, collect the gel, pass it through a 100-mesh sieve by external force, and then sterilize to obtain the cross-linked sodium hyaluronate gel product.

Embodiment 2

[0021] Sodium hyaluronate concentration = 14 w / v%. Alkali concentration = 0.5M, high reaction temperature = 50°C, low reaction temperature = 25°C, crosslinking agent concentration = 1.0v / v% 1,4-butanediol diglycidyl ether

[0022] Take 7.0ml of aqueous sodium hydroxide solution with a concentration of 0.5M and 70μL of cross-linking agent 1,4-butanediol diglycidyl ether, mix the two evenly, and add sodium hyaluronate 1.0 with an average molecular weight of 1.7 million under magnetic stirring. g, after stirring for 5 minutes, put it in a constant temperature water bath at 50°C for 1 hour, and then react at 25°C for 3 days. After the reaction, add 100mL of 0.1M phosphate buffer solution with a pH of 7.0 to the obtained reactant for repeated soaking and cleaning In order to obtain a pH<7.5 and a physiologically acceptable osmotic pressure value, drain the water, collect the gel, pass it through a 100-mesh sieve by external force, and then sterilize to obtain the cross-linked sodiu...

Embodiment 3

[0024] Take 5.0ml of aqueous sodium hydroxide solution with a concentration of 0.5M and 50μL of cross-linking agent 1,4-butanediol diglycidyl ether, mix the two evenly, and add sodium hyaluronate 0.9 with an average molecular weight of 1.7 million under magnetic stirring. g, after stirring for 5 minutes, put it in a temperature-controllable constant temperature water bath at 50°C for 1 hour, and then react at 20°C for 3 days. After the reaction, add 100mL of 0.1M phosphate buffer with a pH of 7.0 The solution is repeatedly soaked and washed to obtain a pH<7.5 and a physiologically acceptable osmotic pressure value, drain the water, collect the gel, pass it through a 150-mesh sieve by external force, and then sterilize to obtain cross-linked hyaluronic acid Sodium acid gel product.

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Abstract

The invention discloses a method for preparing medical cross-linking sodium hyaluronate gel. The method comprises the following steps: mixing and reacting sodium hyaluronate with glycidyl ether under the alkali condition, namely, reacting for 1-4 hours at 40-60 DEG C firstly, further reacting for more than 48 hours at 15-30 DEG C to form the cross-linking sodium hyaluronate gel, washing, performing gelation and crushing the gel into grains of certain sizes, and subsequently sterilizing, thereby obtaining the medical cross-linking sodium hyaluronate gel. By adopting the method, the residual amount of a cross-linking agent can be reduced without a purification step by prolonging the cross-linking reaction time at low temperature, the difficulty that the residual cross-linking agent is hard to remove by using a conventional method is solved, and the prepared gel is uniform in grain and can be used in fields such as the cosmetic industry and the medicinal industry.

Description

technical field [0001] The invention relates to a medical cross-linked sodium hyaluronate gel and a preparation method thereof. The cross-linked sodium hyaluronate gel is used in the field of medicine or cosmetology. Background technique [0002] Hyaluronic acid (Hyalouronic Acid, hereinafter referred to as HA) or its sodium salt is a straight-chain polysaccharide composed of D-glucuronic acid and N-acetylglucosamine disaccharide units repeatedly linked. Important component of lubricating fluid and cartilage tissue. Because of its high viscoelasticity, plasticity and biocompatibility, it is widely used in medical and beauty industries. However, natural HA has strong water solubility, is easy to diffuse and degrade in tissues, and has a short retention time in the body, so its application is limited. In order to make up for these defects, modification and cross-linking methods are usually used to modify hyaluronic acid molecules, change some of its properties, and obtain in...

Claims

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Application Information

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IPC IPC(8): C08J3/24C08J3/075C08L5/08C08K5/1515A61L27/20A61L27/52
Inventor 吴学森张龙军彭益文周奎
Owner 吴学森
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