A kind of breast patch and its preparation and application method

A technology of patch and breast, applied in the field of breast patch

Active Publication Date: 2019-11-19
BEIJING BIOSIS HEALING BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are few reports on immunogen-removed small intestinal submucosa matrix materials used in breast reconstruction

Method used

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  • A kind of breast patch and its preparation and application method
  • A kind of breast patch and its preparation and application method
  • A kind of breast patch and its preparation and application method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] The present embodiment breast patch is prepared as follows:

[0045] (1) Tissue pre-treatment: take the small intestinal submucosa tissue material and divide it into specified sizes, remove the lymphoid tissue, rinse with tap water for 3 times, and then rinse with purified water until the surface is free of stains, place the washed small intestinal submucosa tissue material in Put it on a water filter device such as a strainer, let it stand for more than 5 minutes, and drain the water.

[0046] (2) virus inactivation: adopt peracetic acid-ethanol solution to soak small intestinal submucosa tissue material, this process can be carried out in stainless steel barrel, peracetic acid concentration (volume percentage) adopts 0.1%, ethanol concentration (volume percentage) adopts 5 %, the inactivation time is 2 hours, the ratio (volume ratio) of the solution to the small intestinal submucosa tissue material is 8:1, and the temperature range is 20°C; times, the volume ratio of...

Embodiment 2

[0056] Carry out performance test to sample in embodiment 1, test item and result are as follows:

[0057] 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 3.64±0.96ng / mg.

[0058] 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 color ...

Embodiment 3

[0071] 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.

[0072] 1) Pyrogen

[0073] 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.

[0074] 2) Cytotoxicity

[0075] 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 breast repair patch and preparation and application methods thereof. The breast repair patch is characterized in that the breast repair patch comprises a biodegradable double-layer structure of a concave and convex texture fixing layer and a porous layer, and the double-layer structure adopts small intestinal submucosa materials of animals as raw materials and is prepared from the materials which removes immunogenicity and reserves complete extracellular matrix components. The breast repair patch has the advantages that the breast repair patch is totally new and capable of inducing self cells of patients to grow into the patch, provides a template for cell reformation injured tissue, and is repaired to be vascularized and functionalized tissue or organs, immunogen removal matrix can be degraded gradually and basically synchronous with the reconstructed tissue regeneration process, and finally the immunogen removal matrix patch is completely repalced by host tissue.

Description

technical field [0001] The invention relates to the field of medical biomaterials, in particular to a breast repair sheet for reconstruction of missing breasts, correction of breast deformities, and breast augmentation, and a preparation and application method thereof. Background technique [0002] With the continuous progress of society, more and more women undergo breast plastic surgery in pursuit of beauty to improve their own image, and breast augmentation surgery and plastic surgery will cause breast damage, involving breast repair and reconstruction. Breast reconstruction surgery can be performed for missing breasts and severe breast deformities to reshape the breasts and improve the shape of the breasts. After mastectomy (removal of the breast), due to the loss of a large number of muscles, the autologous skin cannot effectively support the implant, and complications such as sagging or even exposure of the implant will occur. [0003] Breast augmentation is a common ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61L27/36A61L27/50A61L27/58A61L27/56
CPCA61L27/3629A61L27/3683A61L27/50A61L27/56A61L27/58A61L2430/30A61L2430/34A61L2430/40
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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