Preparation method of absorbable haemostasis material

A technology of hemostatic materials and solid materials, which is applied in the field of preparation of absorbable hemostatic materials, can solve problems such as poor stability of cross-linking agent residues, increased difficulty of cross-linking agent removal, and unsolved problems, so as to improve tissue adhesion, Improve the anti-adhesion function and reduce the effect of tissue bleeding

Inactive Publication Date: 2017-08-11
JIANGSU CHANGJIYONG BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Products that have been marketed abroad, because hyaluronic acid is either unmodified or has a low degree of modification, it is easily degraded by hyaluronidase in the body, and the degradation speed is too fast, which affects its anti-adhesion effect
[0005] Modified hyaluronic acid or its salts will have the problem of cross-linking agent residues. The cross-linking agent has potential carcinogenic toxicity, and the removal of the cross-linking agent will increase with the increase of the amount added. The residual amo

Method used

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  • Preparation method of absorbable haemostasis material

Examples

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Effect test

Embodiment 1

[0032] Sodium hyaluronate with a molecular weight of 3 million Daltons was dissolved in water for injection, the temperature was controlled at 4°C, the ultrasonic frequency was 20KHz, intermittently ultrasonicated for 0.5h, left to stand for 1h, and circulated twice to make hyaluronic acid with a concentration of 2.5%. Sodium bicarbonate gel solution, freeze-dried at low temperature to obtain a white material with a thickness of 2mm.

Embodiment 2

[0034] Sodium hyaluronate with a molecular weight of 1.2 million Daltons was dissolved in water for injection, the temperature was controlled at 4°C, the ultrasonic frequency was 20KHz, the ultrasonic frequency was intermittently ultrasonicated for 0.5h, left to stand for 1h, and circulated twice to make hyaluronic acid with a concentration of 1.0%. sodium bicarbonate gel solution, freeze-dried at low temperature to obtain a white material with a thickness of 5mm.

Embodiment 3

[0036] Add sodium hyaluronate with a molecular weight of 100,000 Daltons to 0.05M sodium hydroxide solution, add BDDE cross-linking agent, make the mass ratio of BDDE to sodium hyaluronate 1:40, and participate in the cross-linking reaction hyaluronic acid Sodium acid concentration is 12%, ultrasonic at 10°C, 20KHz for 0.5 hours, stand still for 2 hours, cycle reaction 3 times, use dialysis bags to dialyze the cross-linked gel, replace the dialysate regularly, remove the cross-linking agent, and then inject Wash the salt ions with water to obtain a neutral cross-linked sodium hyaluronate gel with a concentration of 2.5%.

[0037] Mix the neutral cross-linked sodium hyaluronate gel with the uncross-linked sodium hyaluronate gel (prepared in Example 1) according to the mass ratio of 9:1 to obtain a 2.5% mixed sodium hyaluronate gel, which is freeze-dried at low temperature A white material with a thickness of 3 mm was obtained.

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Abstract

The invention discloses a preparation method of an absorbable haemostasis material. The preparation method comprises the following steps: carrying out a cross-linking reaction on a raw material hyaluronic acid or hyaluronate under the action of low-temperature intermittent ultrasonic treatment, uniformly mixing the crosslinked hyaluronic acid or hyaluronate with low-temperature intermittent ultrasonic treatment unreacted hyaluronic acid or hyaluronate, and carrying out ultralow-temperature freeze drying to obtain the absorbable haemostasis material. The low-temperature ultrasonic dissolving technology greatly shortens the hyaluronic acid dissolving time and reduces the pollution probability of the product in the production process; high-molecular weight hyaluronic acid or hyaluronate which can prolong the in-vivo degradation time through improving the solution concentration to meet the wound healing time has large production cost, and is bad for the reduction of the production cost of enterprises; and medium-and-small-molecular weight hyaluronic acid or hyaluronate undergoes the chemical crosslinking reaction under the low-temperature intermittent ultrasonic conditions, and the crosslinked hyaluronic acid or hyaluronate is mixed with the low-temperature intermittent ultrasonic treatment unreacted hyaluronic acid or hyaluronate according to a certain ratio, so the obtained haemostasis material has the advantages of improvement of the anti-adhesion performance, low residual amount of a crosslinking agent, stabilization of the residual amount in a certain range, reduction of the biological risk brought by free crosslinking agents, and reduction of the production cost of the enterprises.

Description

technical field [0001] The invention belongs to the field of biological materials, and in particular relates to a preparation method of an absorbable hemostatic material. Background technique [0002] Hyaluronic acid is a natural polymeric acidic mucopolysaccharide composed of β-D-glucuronic acid and β-N-acetylglucosamine disaccharide units linked by alternating (1→4) and (1→3) glycosidic bonds , is an important component of human and animal skin, vitreous body, joint lubricant and cartilage tissue, with good physical and chemical properties and biocompatibility. [0003] According to the provisions of the National Pharmacopoeia, the appearance of hyaluronic acid or its salts is white or off-white loose fibrous matter or amorphous powder. In practical applications, hyaluronic acid or its salts are often prepared into aqueous solutions. As a macromolecular substance, it is easy to form a colloid on the surface during the dissolution process, which makes the dissolution proce...

Claims

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Application Information

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IPC IPC(8): A61L24/08A61L24/00
CPCA61L24/08A61L24/001A61L24/0042A61L2400/04C08L5/08
Inventor 王风华丁显玉陈勇任恒飞
Owner JIANGSU CHANGJIYONG BIOTECH CO LTD
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