Preparation method for single-phase crosslinked sodium hyaluronate gel

A technology of cross-linking hyaluronic acid and sodium hyaluronate, which is applied in the direction of medical preparations and pharmaceutical formulas of non-active ingredients, and can solve the problem of uneven mixing of biphasic HA, differences in the pushing force of preparations, and unstable quality control and other issues to achieve the effect of reducing the risk of cross-contamination, reducing manual operations, and reducing the risk of clinical use

Active Publication Date: 2018-08-14
ZHEJIANG JINGJIA MEDICAL TECH CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, due to the existence of non-cross-linked sodium hyaluronate, the product itself will have inhomogeneous biphasic HA mixing, resulting in a series of problems such as filling difficulties, differences in the pushing force of the preparation, and unstable quality control etc., will seriously affect product quality and cause adverse effects

Method used

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  • Preparation method for single-phase crosslinked sodium hyaluronate gel
  • Preparation method for single-phase crosslinked sodium hyaluronate gel

Examples

Experimental program
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Effect test

Embodiment 1

[0041] Prepare 100ml of 0.32mol / L sodium hydroxide solution, add 750μL of BDDE, mix well for later use, take 8.0g of sodium hyaluronate raw material at room temperature, mix with the above solution, stir and dissolve until there is no visible white undissolved to the naked eye HA so far. Adjust the temperature of the water bath to 40°C, keep the dissolved HA in the water bath for 3 hours, then take it out, divide the cross-linked HA gel into square blocks with a size of 1-2 cm, and set aside. Prepare a physiological balance solution (containing sodium chloride, sodium dihydrogen phosphate, disodium hydrogen phosphate, water for injection), add the block gel, stir at low speed to swell, replace the buffer at intervals of 1h, 6h and 16h, 10L each time, Stop dialysis until the pH of the buffer reaches neutral and the weight of the gel is about 400 g, reaching the end point of dialysis. The dialyzed gel was taken out, sieved twice with a sieve and preliminarily crushed to obtain ...

Embodiment 2

[0043] Prepare 100ml of 0.32mol / L sodium hydroxide solution, add 750μL of BDDE, mix well for later use, take 8.0g of sodium hyaluronate raw material at room temperature, mix with the above solution, stir and dissolve until there is no visible white undissolved to the naked eye HA so far. Adjust the temperature of the water bath to 60°C, keep the dissolved HA in the water bath for 1 hour, then take it out, divide the cross-linked HA gel into square blocks with a size of 1-2 cm, and set aside. Prepare a physiological balance solution (containing sodium chloride, sodium dihydrogen phosphate, disodium hydrogen phosphate, water for injection), add the block gel, stir at low speed to swell, replace the buffer at intervals of 1h, 6h and 24h, 10L each time, Stop dialysis until the pH of the buffer reaches neutral and the weight of the gel is about 400 g, reaching the end point of dialysis. The dialyzed gel was taken out, sieved twice with a sieve and preliminarily crushed to obtain a...

Embodiment 3

[0045] Prepare 100ml of 0.32mol / L sodium hydroxide solution, add 750μL of BDDE, mix well for later use, take 8.0g of sodium hyaluronate raw material at room temperature, mix with the above solution, stir and dissolve until there is no visible white undissolved to the naked eye HA so far. Adjust the temperature of the water bath to 60°C, keep the dissolved HA in the water bath for 0.5h, then take it out, divide the cross-linked HA gel into square blocks with a size of 1-2 cm, and set aside. Prepare a physiological balance solution (containing sodium chloride, sodium dihydrogen phosphate, disodium hydrogen phosphate, water for injection), add the block gel, stir at low speed to swell, replace the buffer at intervals of 1h, 6h and 24h, 10L each time, Stop dialysis until the pH of the buffer reaches neutral and the weight of the gel is about 400 g, reaching the end point of dialysis. The dialyzed gel was taken out, sieved twice with a sieve and preliminarily crushed to obtain a g...

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Abstract

The invention discloses a preparation method for a single-phase crosslinked sodium hyaluronate gel. The method specifically comprises the following steps: sodium hyaluronate alkali treatment-a 1,4-butanediol diglycidyl ether cross-linking reaction-dialysate dialysis-preliminary granulation-and colloid mill grinding granulation. The method provided by the invention controls a crosslinking degree ofa crosslinking agent and HA through designing reaction conditions, so that a gel with suitable viscoelastic properties is obtained, a gel particle diameter suitable for secondary granulation of a colloid mill is obtained by subsequent preliminary crushing, and finally the crosslinked sodium hyaluronate gel with a target diameter is obtained by selection of appropriate colloid mill granulation parameters; and since the final product has suitable rheological properties, small particle sizes and uniform distribution, artificial operation in the production process can be reduced, the risk of cross contamination is reduced, the production filling process can be met without adding lubricants, the production cycle is shortened, the situation that two-phase cross-linked products are difficult tomix uniformly is avoided, the risk of clinical use is reduced, and product quality is improved.

Description

technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a preparation method of single-phase cross-linked sodium hyaluronate gel. Background technique [0002] The current conventional medical cross-linked sodium hyaluronate gel preparation method mainly includes the following steps: cross-linking reaction-swelling-dialysis-sieve granulation-filling-sterilization, since sodium hyaluronate itself belongs to a polymer substance, Depending on the type of cross-linking agent selected for the cross-linking reaction, the conditions of the cross-linking reaction and other factors, the rheological properties of the final gel are very different. Generally, it is necessary to add non-cross-linked sodium hyaluronate as a lubricant to Meet the requirements of subsequent filling and clinical use. [0003] However, due to the existence of non-cross-linked sodium hyaluronate, the product itself will have inhomogeneous biphasic HA mixin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C08J3/24C08J3/075C08J3/00C08L5/08A61K47/36
CPCA61K47/36C08J3/00C08J3/075C08J3/24C08J2305/08
Inventor 陈亮葛雪飞李建勇
Owner ZHEJIANG JINGJIA MEDICAL TECH CO LTD
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