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Absorbable and degradable biocompatible hemostatic material and preparation method thereof

A technology of biocompatible and hemostatic materials, applied in the field of biocompatible hemostatic materials, can solve the problems of obvious wound scars, poor tissue adhesion, and easy adhesion of patients, and achieve no side effects, complete degradation, and good tissue adhesion Adjunctive effect

Inactive Publication Date: 2015-09-16
上海华惠海洋生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, conventional hemostatic materials such as fibrin glue, gelatin sponge, medical gauze, etc. each have certain shortcomings: gelatin sponge has poor tissue adhesion, and the hemostatic function depends on sufficient platelets and coagulation factors. The application is limited. Fibrin glue comes from blood, which may cause viral infection. Medical gauze not only takes a long time to heal skin wounds, but also has obvious wound scars, and it is easy to stick during dressing changes, which makes patients quite painful.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] To make hemostatic sponges, the clean environment is required to meet the national GMP requirements of 1 million grades, and the local ultra-clean workbench must reach 100,000 grades. The specific production method is as follows:

[0023] 1. Put 10 grams of fish skin collagen in a stainless steel container, add 600ml of 0.5M acetic acid solution, and use a homogenizer to homogenize at a high speed, 10,000 rpm for 10-20 minutes.

[0024] 2. Add 10 grams of chitosan, continue homogenizing for 10 minutes, then add 2 grams of glycerol, homogenizing for more than 10 minutes, until the solution is completely uniform and translucent colloid.

[0025] 3. Lay out the plate and freeze-dry to form a sponge.

[0026] 4. Cut into slices, pack in medical polyethylene packing box, and sterilize by γ-ray irradiation.

Embodiment 2

[0028] 1. Put 100 grams of fish skin collagen in a stainless steel container, add 6000ml of 0.5M acetic acid solution, and use a homogenizer to homogenize at a high speed, 10000 rpm, 10-20 minutes.

[0029] 2. Add 100 grams of chitosan, continue to homogenize for 10 minutes, then add 40 grams of glycerol, and homogenize for more than 10 minutes until the solution is completely uniform and becomes a translucent colloid.

[0030] 3. Lay out the plate and freeze-dry to form a sponge.

[0031] 4. Cut into slices, pack in medical polyethylene packing box, and sterilize by γ-ray irradiation.

[0032] Fish collagen is marine or freshwater fish skin collagen, and the appearance of the hemostatic material is white, spongy and elastic. The ratio of fish collagen, chitosan and plasticizer is the key to realize the effect of the present invention. An inappropriate ratio cannot prepare a hemostatic material with good tissue adhesion, rapid hemostasis and tissue healing.

Embodiment 3

[0033] Example 3. Hemostatic sponge liver hemostasis and in vivo absorption test.

[0034] Take 12 New Zealand rabbits, 6 in the experimental group and 6 in the control group. Depilate and sterilize the rabbit's chest and cut it open to expose the liver. Make a 1-2cm long incision in the liver to make a bleeding model. Apply the hemostatic sponge of the present invention to the bleeding site for a hemostasis test and record the hemostasis time. The control sample uses Absorbable gelatin sponge (produced by Nanjing Jinling Pharmaceutical Factory) purchased on the market, and the hemostasis time was recorded. Then, the chest cavity was closed, sutured, sterilized, and observed for 20 days. Experimental results: the average hemostasis time of the hemostatic sponge of the present invention is 36 seconds, and the hemostasis time of the control product is 156 seconds. After 20 days, the abdominal cavity was cut open, and the placed sponge was completely absorbed, and no inflammati...

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PUM

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Abstract

The invention discloses an absorbable and degradable biocompatible hemostatic material and a preparation method thereof. The hemostatic material is prepared by crosslinking fish collagen and chitosan by virtue of a plasticizer, wherein the weight ratio of the fish collagen to the chitosan to the plasticizer is (1-2):(2-4):(0.1-0.6), and the degree of deacetylation of the chitosan is not less than 80%. The appearance of the hemostatic material is in the shape of white sponge flake with elasticity. The hemostatic sponge provided by the invention can be applied to hemostasis in various operations of the surgical department, the department of stomatology, the department of burn and the department of plastic surgery, is quick in hemostatic effect and good in biocompatibility, does not have immunogenicity, is aseptic, nontoxic and nonirritant, and can be absorbed in vivo. The absorbable and degradable biocompatible hemostatic material is better in safety compared with a hemostatic material prepared from terrestrial animal collagen, and is a more ideal hemostatic material.

Description

technical field [0001] The invention belongs to medical materials, and more specifically relates to an absorbable and degradable biocompatible hemostatic material. Background technique [0002] Collagen has a good hemostatic effect and can be used as a hemostatic material in biomedicine and clinical medicine. Currently approved collagen-based medical material products are all terrestrial animal-derived collagen, and marine animal-derived collagen is only found in the fields of health care products, cosmetics and food. Due to problems such as mad cow disease, avian influenza, and oral diseases, the safety of collagen from terrestrial sources has been questioned. Finding new sources of biological collagen is an important issue that needs to be solved urgently. Marine biological collagen has broad prospects for development and transformation in the field of biomaterials due to its excellent function, good safety, low cost and easy availability. Scholars at home and abroad hav...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L15/32A61L15/28A61L15/64A61L15/40A61L31/04A61L31/14A61L27/24A61L27/20A61L27/58A61L27/50
Inventor 易杨华
Owner 上海华惠海洋生物科技有限公司
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