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Composite membrane for guided bone regeneration and preparation method of composite membrane

A technology for guiding bone regeneration and composite membranes. It is used in tissue regeneration, medical science, non-woven fabrics, etc. It can solve the problems of uneven mechanical strength, low tension resistance of collagen membranes, and collapse, and reduce the incidence of inflammation and infection. , good biocompatibility and mechanical strength, maintaining the effect of maintaining ability and stability

Inactive Publication Date: 2019-01-04
上海白衣缘生物工程有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the pure collagen from porcine collagen, cowhide or bovine tendon that is widely used in clinic at present has the following defects: first, the degradation time in vivo is short; Smaller, it is prone to collapse during the application process and loses the ability to maintain space; third, the collagen membrane is likely to cause local chronic inflammatory reactions
Both Chinese patents CN201710126662.7 and CN201710124188.4 use glutaraldehyde as a cross-linking agent to achieve the effect of improving mechanical properties and reducing the degradation rate, but the introduction of cross-linking agents, especially the introduction of aldehyde cross-linking agents, will affect the human body. Potential toxic side effects, in the long run, it is imperative to find a guided tissue regeneration membrane that does not require the addition of cross-linking agents and can meet clinical needs
[0005] In addition, most of the currently reported guided tissue regeneration membranes are designed in the form of double-layer membranes or multi-layer membranes, but they are prone to delamination and tearing problems.
In order to avoid the multi-layer film from not being tightly bonded, complex processes such as mechanical pressing are required, which affects the microscopic results and repair effect of the recycled film
At the same time, the mechanical strength of the multilayer composite film is not uniform, and the multilayer composite structure makes it feel like a foreign body after implantation, and the clinical application effect is not good.
A kind of periosteum preparation method described in Chinese patent application number CN201710126698.5 can overcome the above-mentioned shortcomings, but its tedious preparation process is not conducive to the actual production in the future

Method used

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  • Composite membrane for guided bone regeneration and preparation method of composite membrane
  • Composite membrane for guided bone regeneration and preparation method of composite membrane
  • Composite membrane for guided bone regeneration and preparation method of composite membrane

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Preparation of Dense Layer of Composite Regenerated Membrane

[0041] (1) Pretreatment

[0042]Freshly slaughtered porcine small intestine tissue was cleaned and soaked in 0.5% acetic acid solution for 30 minutes. The ratio of porcine small intestine to acetic acid solution was 1:5, and the mucosal layer, muscular layer and serosa layer of porcine small intestine and jejunum were removed by physical scraping , Lymph nodes, the submucosa was separated, cut into pieces, and washed 3 times with purified water;

[0043] (2) Virus inactivation

[0044] Use a mixed aqueous solution containing 1.0% peracetic acid and 15% ethanol, the ratio of the SIS material to the mixed aqueous solution is 1:10, and soak at room temperature for 100 minutes under ultrasonic conditions to inactivate the virus. Then use purified water to ultrasonically clean 3 times;

[0045] (3) Remove immunogenic substances

[0046] Use ethanol with a concentration of 95%, the ratio of SIS material to eth...

Embodiment 2

[0054] Immunogenic substance detection is carried out to the sample prepared in embodiment 1

[0055] (1) Detection method of residual cells: fixed with 10% neutral formalin, embedded in paraffin, cut into thin slices of 0.4 micron, dewaxed with xylene, dehydrated with serial alcohol, stained with hematoxylin-eosin, and microscope Observe the cell residue and matrix fiber structure;

[0056] (2) DNA content detection method: according to YY / T 0606.25-2014 "Determination of DNA residues in biological materials of animal origin: fluorescent staining method";

[0057] (3) α-Gal antigen content detection method: After the sample was fixed with paraformaldehyde, it was routinely embedded in paraffin and sectioned, with a thickness of 3 microns. Immunohistochemical reaction was carried out by using the specific affinity between biotin-labeled BSI-B4 and α-Gal antigen. Judgment of staining results: dark brown-yellow particles are strongly positive (+++), brown-yellow particles are ...

Embodiment 3

[0061] Antibacterial property detection is carried out to the sample prepared by embodiment 1

[0062] Grind the sample prepared in Example 1 in 0.01 M hydrochloric acid with a grinding rod until no particles are visible to the naked eye, and adjust its concentration to 100 mg / 10 mL. Add pepsin for digestion, pepsin:sample ratio is 1:10. Stir continuously at 25°C for 48h, then cool down to 4°C, add 1 / 10 volume of 0.1 M sodium hydroxide to adjust the pH to 7.2-7.4;

[0063] Prepare a mixed culture medium plate, and use an inoculation loop to pick a small amount of cultured Staphylococcus aureus and Escherichia coli slant medium into 5ml sterile normal saline to make a bacterial suspension. Take 1.0ml of the bacterial suspension and 1ml of the above-mentioned degraded sample and add it to a sterilized and dried petri dish, add the ordinary nutrient broth agar medium cooled to about 50°C, shake well, and wait until it is fully condensed for later use. Incubate upside down at 37...

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Abstract

The invention discloses a composite membrane for guided bone regeneration and a preparation method of the composite membrane. The preparation method of the composite membrane includes the operation steps: treating pig jejuna by a mechanical method to obtain small intestinal submucosa; performing multilayer horizontal-vertical overlapping after processes such as acid, decontaminant and alkali treatment to obtain a compact layer; uniformly spinning prepared collagen solution on the compact layer by an electrospinning technique, and performing compounding and vacuum freeze-drying to obtain the composite membrane. The composite membrane prepared by the method has excellent biocompatibility and bioactivity and is easily absorbed by tissues, the compact layer in a structure can selectively stopsoft tissues from growing into a bone defect area, a loose layer is of a loose porous structure and large in specific surface area by the aid of the electrospinning technique, combination of two membranes, cell adhesion and growing into pores are facilitated, new tissue regeneration can be supported by the aid of bioactive factors or medicines, and wound healing is promoted. By combination, the composite membrane achieves excellent mechanical performance and can keep a regeneration space stable within a certain time.

Description

technical field [0001] The invention relates to the field of biomedical materials, in particular to a double-layer natural composite membrane for guiding bone regeneration, which is used for repairing bone tissue and periodontal tissue. . Background technique [0002] Guided bone tissue regeneration is currently the best clinical choice for tissue defect repair. Its principle is to prevent soft tissue from entering the bone growth area through the physical barrier of the regeneration membrane, and reserve regeneration space for new bone growth in the bone defect area. And guide osteoblasts to grow into new bone in the bone defect area, so as to achieve the purpose of bone healing. [0003] The first-generation regenerative membrane materials used for guided bone regeneration in the early days were non-degradable materials represented by polytetrafluoroethylene (e-PTFE). Since such materials cannot be absorbed by tissues, a second operation is required after 4-6 weeks of pla...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/50A61L27/54A61L27/22A61L27/24A61L27/36D04H1/728
CPCA61L27/22A61L27/227A61L27/24A61L27/3629A61L27/365A61L27/3687A61L27/50A61L27/54A61L2300/252A61L2300/404A61L2300/412A61L2300/414A61L2430/02A61L2430/40C08L89/00
Inventor 韩韦红葛翠兰钱锵
Owner 上海白衣缘生物工程有限公司
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