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Dense double-layer biological membrane, preparation method and application

A technology of biofilm and biomedical materials, applied in medical science, prosthesis, etc., can solve the problems of increased operational complexity, no interaction force, increased cost, etc., to improve tissue repair effect, prevent ingrowth and proliferation, The effect of increasing tightness

Active Publication Date: 2020-09-29
福建纽伯尔生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0003] However, there are still some shortcomings in the performance of the double-layer film products widely used in clinical practice.
[0004] One is that the double-layer membrane often separates during the immersion in physiological saline, which affects the operation and use effect.
It is speculated that the reason is that the existing preparation method of sparse and dense double-layer biofilms is only to press the two layers of films that were freeze-dried separately. Since there is basically no interaction force between the two layers of films, they are easy to separate.
In Chinese patent CN107412869A, two layers of membranes are bonded with fibrinogen and prothrombin solution during preparation, which increases the cost and complexity of operation
In addition, the addition of other substances has unknown effects on the safety and effectiveness of the product
[0005] In addition, due to the limitation of the concentration of the polymer solution, the freeze-dried dense layer still has a large pore size and porosity, which cannot effectively prevent cell growth. Due to reasons such as regeneration space, the tissue repair function of the membrane is not ideal

Method used

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  • Dense double-layer biological membrane, preparation method and application
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  • Dense double-layer biological membrane, preparation method and application

Examples

Experimental program
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Effect test

Embodiment 1

[0030] A method for preparing a dense double-layer biofilm, comprising the following steps:

[0031] S1, chitosan is made into a solution of 8wt% as a dense layer solution; then chitosan is made into a solution of 2wt% as a loose layer solution; the pH of the dense layer solution is 3.4, and the loose layer The pH of the solution is 4.5; the dense layer solution and the loose layer solution are degassed by centrifuging the dense layer solution and the loose layer solution at a temperature of 4°C and a speed of 3200 rpm for 10 minutes, respectively;

[0032] S2, pour the dense layer solution into a custom-made utensil, shake it evenly, and air-dry it at a temperature of 10°C and a humidity of 50% until the concentration of the dense layer solution is 60wt%, and then place it at -30°C for 2 hours to form a dense layer ;

[0033] S3, pour the loose layer solution onto the dense layer frozen in step S3, oscillate evenly, and thaw at 2°C; after the dense layer melts, put it in a r...

Embodiment 2

[0039] A method for preparing a dense double-layer biofilm, comprising the following steps:

[0040] S1, make hyaluronic acid into a 10wt% solution as the compact layer solution; then make hyaluronic acid into a 2.5wt% solution as the loose layer solution; set the pH of the dense layer solution to 3.8, and the loose layer solution The pH of the layer solution is 5.0; the dense layer solution and the loose layer solution are degassed by centrifuging the dense layer solution and the loose layer solution at a temperature of 3 ° C and a speed of 3200 rpm for 8 minutes;

[0041] S2, pour the dense layer solution into a custom-made utensil, shake it evenly, and air-dry it at a temperature of 8°C and a humidity of 40% until the concentration of the dense layer solution is 50wt%, and then put it in -20°C for 1.5 hours to form a dense layer ;

[0042] S3, pour the loose layer solution onto the dense layer frozen in step S3, oscillate evenly, and thaw at 4°C; after the dense layer melt...

Embodiment 3

[0048] A method for preparing a dense double-layer biofilm, comprising the following steps:

[0049] S1, sodium alginate is made into a solution of 8wt% as a dense layer solution; then sodium alginate is made into a solution of 2wt% as a loose layer solution; the pH of the dense layer solution is 3.2, and the loose layer The pH of the solution is 4.0; the dense layer solution and the loose layer solution are degassed by centrifuging the dense layer solution and the loose layer solution at a temperature of 4 ° C and a speed of 3200 rpm for 10 minutes;

[0050] S2, pour the dense layer solution into a custom-made utensil, shake it flat, air-dry it at a temperature of 15°C and a humidity of 70% until the concentration of the dense layer solution is 60wt%, and then place it in -30°C for 1 hour to form a dense layer ;

[0051] S3, pour the loose layer solution onto the dense layer frozen in step S3, oscillate evenly, and thaw at 2°C; after the dense layer melts, put it in a refriger...

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Abstract

The invention provides a preparation method of a dense double-layer biological membrane. The preparation method comprises the following steps that S1, a natural polymer biomedical material is preparedinto a 5-10wt% solution to be used as a dense layer solution; then the natural polymer biomedical material is prepared into a 1.5-2.5 wt% solution to be used as a porous layer solution; the dense layer solution and the porous layer solution are correspondingly centrifuged by a refrigerated centrifuge for 5-10 minutes for defoaming; S2, the dense layer solution is poured into a custom-made appliance for being flatly oscillated, air-drying is carried out under the conditions that the temperature is 5-15 DEG C and the humidity is 30-70% until the concentration of the dense layer solution is 20-80wt%, and then the dense layer solution is placed at the temperature of -20 DEG C to -40 DEG C for freezing for 1-2 hours to form a dense layer; S3, the porous layer solution is poured into the densecompact layer frozen in the step S3 for being flatly oscillated and being thawed at 1-4 DEG C; the dense layer is put into the refrigerated centrifuge to be centrifuged for 5-10 minutes under the conditions that the temperature is 6-7 DEG C and the rotating speed is 3200-3500 revolutions per minute after the dense layer is melted; and S4, after vacuum freeze drying, heating is carried out for 1-2hours at the temperature of 50-70 DEG C for fixation, and electron rays with the irradiation dose of 10-30 kGy are adopted for irradiation. The two layers of the membrane are tightly bonded.

Description

technical field [0001] The invention relates to a dense double-layer biofilm, a preparation method and an application thereof, and belongs to the technical field of medical devices. Background technique [0002] Density-dense bilayer biofilm is a commonly used restorative material in clinical practice. The loose structure on one side can promote the repair and regeneration of tissue disease defects, and the dense layer on one side can effectively prevent the growth of fibroblasts. [0003] However, there are still some shortcomings in the performance of the double-layer film products widely used in clinical practice. [0004] One is that the double-layer membrane often separates during the immersion in physiological saline, which affects the operation and use effect. It is speculated that the reason is that the existing method for preparing a sparse-dense double-layer biofilm is only to press the two layers of membranes that were freeze-dried separately. Since there is bas...

Claims

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Application Information

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IPC IPC(8): A61L27/20A61L27/24A61L27/40A61L27/50
CPCA61L27/20A61L27/24A61L27/50C08L5/08C08L5/04C08L89/00
Inventor 陈燃
Owner 福建纽伯尔生物科技有限公司