Non-toxic cross-linked sodium hyaluronate gel articular cavity injection and preparation method thereof

A technology of sodium hyaluronate and articular cavity, which is applied in the direction of pharmaceutical formula, aerosol delivery, medical preparations of non-active ingredients, etc. It can solve problems such as toxicity, reduce toxicity, reduce the probability of adverse reactions, and have a stable structure Effect

Pending Publication Date: 2021-04-20
SHANGHAI HAOHAI BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Therefore, from non-cross-linking to cross-linking is the trend of product development and replacement, but the cross-linking agents for cross-linking sodium hyaluronate are mainly DVS and BDDE, but these cross-linking agents have certain toxicity

Method used

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  • Non-toxic cross-linked sodium hyaluronate gel articular cavity injection and preparation method thereof
  • Non-toxic cross-linked sodium hyaluronate gel articular cavity injection and preparation method thereof
  • Non-toxic cross-linked sodium hyaluronate gel articular cavity injection and preparation method thereof

Examples

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Embodiment 1

[0040] This example describes the preparation process of the cross-linking reaction between sodium hyaluronate and L-lysine, and detects the shear viscosity of the product.

[0041]Add 100 mL of phosphate buffer solution and 2 g of sodium hyaluronate raw material into a 500 mL round bottom flask, stir overnight at room temperature to dissolve. Add 1g of L-lysine into the reaction system, stir at 2-8°C for 2h, add 1g of DMTMM to catalyze the cross-linking reaction, and stir at 2-8°C for 24h to carry out the cross-linking reaction. Add ethanol to the obtained reaction product to precipitate and collect, and use ethanol to wash the obtained precipitate 3 times for 10 minutes each time, until the precipitate completely loses water, put the precipitate in a vacuum dryer and dry it for 24 hours to obtain a slightly cross-linked glass Sodium acid gel dry powder. Use phosphate buffer solution to redissolve the dry powder, add the dry powder to the phosphate buffer solution and dissol...

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Abstract

The invention relates to the technical field of medical injections, in particular to a non-toxic cross-linked sodium hyaluronate gel articular cavity injection and a preparation method thereof. The product is gel formed by cross-linking sodium hyaluronate serving as a main body and amino acid containing two or more amino groups serving as a cross-linking agent under the action of a catalyst. The preparation method comprises the following steps of dissolving sodium hyaluronate in a certain amount of solvent I; then adding the cross-linking agent for dissolving; adding the catalyst, and carrying out a cross-linking reaction; dialyzing a product obtained by crosslinking through the solvent I to remove the cross-linking agent and the catalyst remained in the cross-linking reaction process; or carrying out precipitation collection on the product obtained by cross-linking by using a solvent II, drying, and dissolving the precipitation product in the solvent I until the required concentration is achieved; and filling the obtained product into a pre-filled syringe under a sterile condition, sterilizing the filled product, and carrying out light inspection to obtain the final product. The product is high in liquidity and long in degradation time, and reduces infection risks and pains of patients.

Description

technical field [0001] The invention relates to the technical field of medical injections, in particular to a bone and joint cavity injection. Background technique [0002] In recent years, with the intensification of social aging, the proportion of China's elderly population is increasing rapidly. Osteoarthritis (OA) is a chronic degenerative bone and joint disease common in the elderly, which seriously affects the quality of life of the elderly. It is estimated that by 2020, osteoarthritis will become the fourth most disabling disease , which will bring a huge economic burden to patients, their families and society. The research results from the China Health and Pension Tracking Survey database show that the prevalence of knee symptomatic OA in my country is 8.1%, and women are higher than men; there are obvious regional differences, namely the southwest region (13.7%) and the northwest region ( 10.8%) is the highest, while North China (5.4%) and eastern coastal areas (5....

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K31/728A61K47/18A61P19/02
Inventor 张军东杜敬霆刘璐吴剑英
Owner SHANGHAI HAOHAI BIOLOGICAL TECH
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