Crosslinking hyaluronic acid sodium gel for injection and preparation method thereof

A technology of cross-linking hyaluronic acid and sodium hyaluronate, which is applied in the field of medicine, can solve the problems of unsatisfactory retention time and easy diffusion, and achieve the effect of less impurities, simple process, and uniform and fine particles

Active Publication Date: 2009-08-12
SHANDONG FREDA PHARMA GRP CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, natural HA is easily degraded by enzymes in body tissues, and its good water solubility makes it easy to diffuse in tissues, so its local retention time in animal tissues is not satisfactory

Method used

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  • Crosslinking hyaluronic acid sodium gel for injection and preparation method thereof
  • Crosslinking hyaluronic acid sodium gel for injection and preparation method thereof
  • Crosslinking hyaluronic acid sodium gel for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Take 10g SH (average molecular weight 1.8 million Daltons) and 68ml 1% NaOH solution containing 0.5g BDDE and mix evenly. The resulting reaction solution is incubated at 50°C for 3 hours to form a water-insoluble gel. In order to illustrate the advantages of the process of the present invention, the gel obtained by the reaction is divided into 2 parts on average, 1 part is prepared according to the method of the present invention (A), and the other part is prepared according to the method disclosed in WO026350 (B). For ease of comparison, gel B The same purification temperature and phosphate buffer system as gel A were used.

[0029] A: After purifying with deionized water at 70°C for 10 hours, squeeze the gel through a 60-mesh sieve (the inner diameter of the sieve is 250 μm), collect the gel particles, and add an equal volume of isotonic PBS with a concentration of 2 times (each 1000ml contains NaH 2 PO 4 2H 2 O 90mg, Na 2 HPO 4 12H 2 O1.12g, NaCl 17g), incubated...

Embodiment 2

[0042] Take 10 g of SH (average molecular weight: 1.2 million Daltons) and dissolve in 90 ml of 1.5% NaOH solution containing 0.8 g of BDDE. In order to illustrate the advantages of the process of the present invention, the reaction solution is evenly divided into 2 parts, 1 part is prepared according to the reaction conditions of the method of the present invention (C), and the other part is prepared according to the reaction conditions disclosed in CN1590444 (D).

[0043] The C reaction solution was incubated at 50° C. for 2 hours to form a water-insoluble gel.

[0044] The D reaction solution was incubated at 20° C. for 24 hours to form a water-insoluble gel.

[0045] For ease of comparison, the gel post-treatment processes (purification, particle preparation and sterilization, etc.) obtained by reactions C and D all adopt the preparation method of the gel in Example 1A.

[0046] In order to compare the different properties of the obtained gel, the gel was tested according...

Embodiment 3

[0051] Dissolve 5 g of SH with different molecular weights (average molecular weight: 300,000, 420,000, 570,000, and 780,000 Daltons) in 35 ml of 1.0% NaOH solution containing 0.25 g of BDDE. According to the preparation method of the gel in Example 1A, 4 kinds of gels with different properties were obtained respectively, and the gel was tested according to the method described in Example 1, and the results are shown in Table 3.

[0052] Table 3 Comparison of determination data of 4 kinds of gels

[0053]

[0054] SH with different molecular weights can be prepared into water-insoluble gel particles by the same process, and its content, yield and enzyme resistance increase with the increase of molecular weight.

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Abstract

The invention relates to a cross bonding sodium hyaluronate gel for injection and a preparation method thereof. The method is characterized in that sodium hyaluronate and glycidyl ether are mixed and react in alkaline solution to form water-insoluble gel, the gel is purified in deionized water and broken into particles of certain sizes; ionic strength of the deionized water is improved to contract the gel particles. The cross bonding sodium hyaluronate gel features asepsis, apyrogeneity and small and uniform particles; therefore the gel can be applied to prepare injection for beauty care and medical treatment.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a cross-linked sodium hyaluronate gel for injection and a preparation method thereof. Background technique [0002] Hyaluronic acid (hereinafter referred to as HA) is composed of (1-β-4) D-glucuronic acid and (1-β-3) N-acetyl-D-glucosamine disaccharide units repeatedly linked It is a chain polyanionic mucopolysaccharide, which is an important component of skin, vitreous body, synovial fluid and cartilage tissue, and has unique physical and chemical properties and biological functions. Commercial sodium hyaluronate (sodium hyaluronate, hereinafter referred to as SH) is the sodium salt of HA. It is derived from animal tissue or microbial fermentation. It is widely used in food, daily chemical and pharmaceutical fields. Due to the difference in purity, it has food grade, medical grade and Cosmetic grade and other grades of products. After long-term research and development, high-purity medic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/04
Inventor 凌沛学陈建英贺艳丽郭学平汪敏刘杰刘建建荣晓花
Owner SHANDONG FREDA PHARMA GRP CO LTD
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