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A kind of biological anti-adhesion material, preparation method and application thereof

An anti-adhesion and biological technology, applied in the field of medical device biomaterials, can solve the problems of easy flow of chitosan gel or solution, insufficient mechanical strength and toughness, and difficulty in forming higher concentrations, and achieves good biocompatibility, The effect of preventing adhesion and preventing adhesion formation

Active Publication Date: 2020-05-05
BEIJING BIOSIS HEALING BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, some polymer materials have some problems. For example, the degradation products of polylactic acid are acidic, and local accumulation is easy to cause mild aseptic inflammation; chitosan gel or solution is easy to flow, and it is not easy to form a high concentration locally, while spongy or The mechanical strength and toughness of film-like chitosan are not enough

Method used

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  • A kind of biological anti-adhesion material, preparation method and application thereof
  • A kind of biological anti-adhesion material, preparation method and application thereof
  • A kind of biological anti-adhesion material, preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] The preparation method of the animal-derived implantable biological anti-adhesion material in this embodiment includes the following steps:

[0048] (1) Organization pre-processing:

[0049] Take the small intestinal submucosa tissue material and divide it into the specified size of 10cm wide and 15cm long, remove the lymphatic tissue, rinse with tap water 3 times, and then rinse with purified water until there is no stain on the surface, and then put the cleaned small intestinal submucosa tissue material on the screen Wait for the water filter device, let it stand for more than five minutes, and drain the water.

[0050] (2) Virus inactivation:

[0051] Use peracetic acid-ethanol solution to soak small intestinal submucosa tissue material for virus inactivation, and this process can be carried out in a stainless steel bucket. The concentration (percentage by volume) of peracetic acid in peracetic acid-ethanol solution is 1%, the concentration (percentage by volume) o...

Embodiment 2

[0068] Carry out performance test to sample in embodiment 1, test item and result are as follows:

[0069] 1) DNA residue: According to the fourth part of the biological agent residual DNA detection method "Chinese Pharmacopoeia" 2015 edition, the fluorescence staining method was used to detect the DNA residue of the sample provided in Example 1, and the result: the DNA residue of the sample provided in Example 1 The amount is less than 2.89±0.36ng / mg.

[0070] 2) Clearance rate of galactosidase (α-Gal): Take 2mg each of animal-derived biological material Gal positive reference substance and Gal antigen negative reference substance, add 1ml of lysate, lyse for 30-90min, and prepare 20, 10, 5 , 2.5, 1.25, and 0.625 μg of Gal standard curve samples, take 50 mg of each test product before and after immunogen removal, add 2 ml of lysate, and lyse for 30-90 min; take the supernatant after the lysate reacts with M86 antibody, add 96 Orifice plate, add secondary antibody, add chromo...

Embodiment 3

[0082] Biocompatibility experiments were carried out on the samples in Example 1, and the detection items included: pyrogen, cytotoxicity, delayed hypersensitivity reaction, intradermal reaction, acute systemic toxicity, Ames test, mouse lymphoma cell mutation test, chromosomal aberration , implantation, subchronic toxicity.

[0083] 1) Pyrogen

[0084] The test solution was prepared according to the ratio of extraction medium at a mass ratio of 1:5, 37±1°C, 72±2hr, extraction medium: normal saline. According to the method specified in GB / T 14233.2-2005, the product has no pyrogen reaction.

[0085] 2) Cytotoxicity

[0086] Prepare the test solution according to the ratio of extraction medium with a mass ratio of 1:5, 37±1°C, 24±2hr, extraction medium: MEM medium containing serum. Take the test solution and carry out the test according to the test method specified in GB / T16886.5-2003, and the result is that the cytotoxic reaction of the product is not greater than grade 1. ...

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Abstract

The invention provides a biological anti-adhesion material, a preparation method and application thereof. The biological anti-adhesion material is characterized in that the biological anti-adhesion material is prepared by using a small intestinal submucosa tissue material of an animal as a raw material, eliminating immunogenicity and retaining complete extracellular matrix ingredients and comprises a first surface, a second surface and a degradable absorbing structure positioned therebetween, the first surface is a smooth surface, the second surface is a coarse surface, and the degradable absorbing structure is in gradually-varied connection. The coarse surface of the biological anti-adhesion material is conducive to guiding growth of wound surface tissue cells so as to repair the wound surface; the smooth surface is conducive to stopping the cells to be adhered to other tissue so as to effectively prevent adhesion. The biological anti-adhesion material can be used for anti-adhesion treatment of the wound surface in enterocoelia, thorax or pelvic cavity.

Description

technical field [0001] The invention relates to the field of medical device biomaterials, in particular to an anti-adhesion material used to prevent wound adhesion, a preparation method and an application thereof. Background technique [0002] Adhesions are abnormal structures where fibrous bands of connective tissue join together with adjacent tissues or organs. The incidence of postoperative adhesions is as high as 90%, and thoracic, abdominal and pelvic surgeries can lead to different degrees of adhesions. Clinically serious complications caused by adhesions include intestinal obstruction, infertility, chronic pelvic pain, etc., which increase the chance of secondary surgery. Furthermore, even with a second surgery, the same potential for postoperative re-adhesions and recurrence of complications remains. At present, there are two ways to prevent postoperative tissue adhesion at home and abroad. One is a treatment method based on physiological / pharmacological mechanisms...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L31/14A61L31/00
CPCA61L31/005A61L31/14A61L2430/40
Inventor 赵博王洪权夏磊磊赵延瑞李学军张晋辉
Owner BEIJING BIOSIS HEALING BIOLOGICAL TECH
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