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Anal fistula suppository and preparation method thereof

A technology of biological embolism and anal fistula, applied in medical science, prosthesis and other directions, can solve the problems of affecting the anti-infection ability of products, tissue regeneration ability, destroying three-dimensional structure, product instability, etc. High stability, guaranteed stability and uniformity

Active Publication Date: 2013-09-04
BEIJING BIOSIS HEALING BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

On the other hand, Biodesign Surgisis products use common hybrid pigs as animal sources, and individual differences in the genetic background of hybrid animals lead to instability and inconsistency in different batches of products
On the other hand, the vacuum compression freeze-drying molding process adopted by Biodesign Surgisis products compresses the spatial structure of the SIS matrix material, destroys the natural three-dimensional structure of ECM, and affects the anti-infection ability of the product and the ability to promote tissue regeneration

Method used

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  • Anal fistula suppository and preparation method thereof
  • Anal fistula suppository and preparation method thereof
  • Anal fistula suppository and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Example 1: Preparation of 4-layer anal fistula bioembolism

[0043] The preparation method is as follows:

[0044] (1) Determination of animal source and pretreatment and initial washing of small intestine tissue

[0045] The Chinese inbred Wuzhishan minipig was selected as the animal source, and the animal species was determined using the method specified in the patent ZL200510008994.2. The small intestine tissue of the freshly slaughtered Chinese inbred Wuzhishan minipig was cleaned, and the small intestinal submucosa was separated and used Rinse with water for injection 3 times.

[0046] (2) Virus inactivation

[0047] The peracetic acid-ethanol solution method is used to inactivate the virus. This step is carried out in a constant temperature ultrasonic cleaner that can shake the cleaning tank. The volume percentage of peracetic acid is 0.05~0.2% (preferably 0.1%). The time is 1~2h (preferably 1h), the temperature range is 4~40°C, and then washed 2~5 times in pho...

Embodiment 2

[0056] Embodiment 2: Physical and chemical properties, histology, growth factors and biological performance detection of the material prepared in embodiment 1

[0057] 1. Porosity determination

[0058] Porosity determination: Mercury porosimetry was used to determine the porosity of the material and compared with and compared with Biodesign Surgisis products. Results: The porosity of the sample provided in Example 1 was 87.8±2.51, and the porosity of the Biodesign Surgisis product was 78.3±6.38.

[0059] 2. Chemical performance testing, testing items include virus, pH, endotoxin and DNA residue.

[0060] 1) Preparation of test solution: Preparation of test solution: take the uniform thickness part of the sample and cut it into 1cm 2 fragments, washed with water, dried, and then added to a glass container, according to the total surface area of ​​the inside and outside of the sample (cm 2 ) to water (mL) at a ratio of 5:1, add water, cover and place in a pressure steam ster...

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Abstract

The invention provides an anal fistula biological suppository and a preparation method thereof. The anal fistula biological suppository uses small intestine submucosa tissues of inbred line animals without cell and DNA (deoxyribonucleic acid) components as the raw material, completely reserves the extracellular matrix component and structure, and has a micropore structure. The preparation method of the anal fistula biological suppository comprises the following operation steps: determination of animal source, pretreatment and rough cleaning of small intestine tissues, virus inactivation, cell removal, DNA removal treatment, formation, packaging and sterilization. The anal fistula biological suppository prepared by the method uses an inbred line animal as an animal source, and thus, the hereditary features are pure, stable and uniform, thereby radically ensuring the stability and uniformity of different batches of products; and the anal fistula biological suppository has fewer animal source DNA residues, completely reserves the three-dimensional structure of natural ECM, and has the advantages of low immune source property and high infection resistance.

Description

technical field [0001] The invention relates to the technical field of animal-derived implantable medical devices, in particular to an anal fistula biological embolus and a preparation method thereof. Background technique [0002] Anal fistula is a chronic infectious duct with the same perianal skin and rectum / anal canal. It is the inevitable result after the healing of perianal abscess. second. The main method of treatment of anal fistula is surgical treatment. Traditional surgical methods include anal fistula resection, thread therapy, drainage of fistula tract, transanorectal mucosal flap repair and other surgical methods. These surgical treatments all have problems of anal dysfunction and recurrence. Postoperative anal The incidence of incontinence is between 10% and 65%, the recurrence rate of postoperative anal fistula is between 10% and 20%, and the quality of life of patients is very poor. At present, it is believed that both the healing of anal fistula and the ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/36A61L27/56
Inventor 赵博王振军
Owner BEIJING BIOSIS HEALING BIOLOGICAL TECH
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