Otological repair material and preparation method and application thereof

A prosthetic material and otology technology, applied in medical science, tissue regeneration, prosthesis, etc., can solve problems such as increasing the difficulty of surgery and affecting the hearing recovery of the tympanic membrane

Active Publication Date: 2017-07-28
BEIJING BIOSIS HEALING BIOLOGICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Moreover, the thickness of these materials, whether autologous or allogeneic, is much larger than that of the tympanic membrane, which affects the hearing recover

Method used

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  • Otological repair material and preparation method and application thereof
  • Otological repair material and preparation method and application thereof
  • Otological repair material and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] The ear repair material of this embodiment is prepared as follows:

[0054] (1) Tissue pre-treatment: Take small intestinal submucosa tissue materials for segmentation, remove lymphatic tissue, rinse with tap water, and then rinse with purified water until the surface is free of stains, and place the washed small intestinal submucosa tissue materials in a filter such as a filter. Put it on the water device, let it stand for more than 5 minutes, and drain the water.

[0055] (2) virus inactivation: adopt peracetic acid-ethanol solution to soak small intestinal submucosa tissue material, this process can be carried out in stainless steel bucket, peracetic acid concentration (volume percentage) adopts 0.6%, ethanol concentration (volume percentage) adopts 7 %, the inactivation time is 2 hours, the ratio (volume ratio) of the solution to the small intestinal submucosa tissue material is 9:1, and the temperature range is 20°C; The volume ratio of PBS solution to small intes...

Embodiment 2

[0066] Carry out performance test to sample in embodiment 1, test item and result are as follows:

[0067] 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.

[0068] 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

[0079] 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.

[0080] 1) Pyrogen

[0081] 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.

[0082] 2) Cytotoxicity

[0083] 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 relates to an otological repair material and a preparation method and application thereof; the otological repair material is made with intestinal submucosal matrix material with immunogens removed; the repair material comprises a base layer and one or more protrusion portions arranged on the base layer; the repair material can induce cell ingrowth of a patient, a template is provided for reconstructed damaged issues for cells, and the functional tissues or organs are repaired; the immunogen removal matrix may degrade gradually in substantial sync with the reconstructed tissue regeneration process, an immunogen-removed matrix patch is completely replaced by host tissues, and otological recovery is achieved accordingly. The repair material never causes immunogen reaction, and a required shape is easy to process. A patient has no need to bear extra surgical pain.

Description

technical field [0001] The invention relates to the field of medical biological materials, in particular to an ear repair material (biological repair sheet), a preparation method and an application. Background technique [0002] The tympanic membrane, also known as the eardrum, is an oval translucent membrane located at the junction of the tympanic cavity of the middle ear and the external auditory canal, forming the outer wall of the tympanic cavity and separating the external auditory canal and the middle ear cavity. In the process of auditory conduction, the structure of the tympanic membrane can amplify the incoming sound waves, and through the interaction with the auditory ossicles, the external sound is transmitted to the auditory nerve, so that the organism obtains the perception of external sound. Because the tympanic membrane itself is relatively fragile, infection, cholesteatoma, contact with foreign objects, or a large pressure difference between the inner and out...

Claims

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Application Information

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IPC IPC(8): A61L27/36A61L27/58A61L27/56
CPCA61L27/3629A61L27/3645A61L27/3687A61L27/56A61L27/58A61L2430/14A61L2430/40
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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