CN107320786B - Slow-release anti-infection composite soft tissue repair material and preparation method thereof - Google Patents
Slow-release anti-infection composite soft tissue repair material and preparation method thereof Download PDFInfo
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
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- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/36—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
- A61L27/3604—Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
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- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
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- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
- A61L2300/602—Type of release, e.g. controlled, sustained, slow
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Abstract
The invention relates to a slow-release anti-infection composite soft tissue repair material and a preparation method thereof. The medium containing anti-infection components is placed between or on the surface of the biological material layer at intervals according to the radius of the drug sensitive test inhibition zone, and is integrated by means of adhesive, suture or pressure. The invention can effectively and continuously release anti-infection components, does not change the biocompatibility of the biological material, is nontoxic and harmless, and has good application prospect.
Description
Technical Field
The invention belongs to the field of soft tissue repair materials and preparation thereof, and particularly relates to a slow-release anti-infection composite soft tissue repair material and a preparation method thereof.
Background
Biomaterials are important advances in the study of soft tissue repair materials, with representative materials that are infection-resistant and remodelable including synthetic biomaterials (e.g., P4HB, fibroin fibers, collagen, chitosan, etc.) and acellular matrix biomaterials. Compared with the traditional non-absorbable high molecular material, the biological material is used as a temporary tissue scaffold after being implanted into a body, and host cells infiltrate into the tissue scaffold and generate autologous collagen fibers along with the degradation of the patch material. The process of endogenous tissue remodeling can realize early local rapid revascularization and early entry of phagocytes, and a bacterial biomembrane is difficult to form, so that the tissue remodeling has certain resistance to infection. It is undeniable, however, that the biomaterial is only partially resistant to infection and not to infection, that it has no antimicrobial activity on its own, and that the non-crosslinked acellular matrix biological patch rapidly disintegrates in an infectious environment upon digestion by bacterial secreted collagenases. Thus, there is a great need for biomaterials that improve infection resistance.
In this regard, advances have included: chinese invention patents CN102014790A and CN101623518A respectively disclose methods for improving the anti-infection performance of biological patches by infiltrating acellular matrix biological materials with antibacterial metal particles such as nano silver and silver ions. The results of in vitro antibacterial experiments and animal experiments show that the infection rate of the acellular matrix biological material can be reduced, and the success rate of repairing the polluted wound surface is improved. The improved biological patch has a satisfactory anti-infection effect, but as the antibacterial components are only adsorbed to the material net structure and are loosely combined, a large amount of antibacterial components are released in a short time after implantation, so that the later antibacterial effect of a repair area is poor. Chinese patent CN103751844A discloses a preparation method and application of an antibacterial and anti-degradation porcine small intestine mucosa acellular matrix. The antibacterial and anti-degradation biological material is prepared from the pig small intestine mucosa acellular matrix treated by genipin, dopamine and nano-silver, the dopamine has viscosity, and antibacterial components can be bound to the collagen fiber scaffold under the action of chemical bonds. However, when applied to contaminated surfaces, acellular matrix biomaterials significantly increase the infection rate in the repair area compared to non-crosslinked materials, probably because crosslinking reduces the porosity of the material, and too small pores are not conducive to cell invasion to achieve early vascularization, and are prone to bacterial colonization and bacterial biofilm formation. The Chinese patent CN101810883A discloses a biological derivative material with high tissue compatibility and long-acting anti-infection, which comprises acellular matrix and absorbable anti-infection nanoparticles, wherein the absorbable anti-infection nanoparticles release the drug in a short time after being implanted into the body, the effective concentration is quickly reached, and the effective blood concentration lasts for 2 weeks to 3 months. Chinese patent CN102172418A discloses a cell-free matrix material for sustained release of growth factors, which comprises degradable hydrophobic polymer, angiogenesis growth factors and cell-free matrix, and the nanometer sustained release system is compounded into the cell-free matrix, so that the sustained release growth factors still effectively maintain biological characteristics, and the sustained release process is long and stable. However, the preparation processes of the nanoparticles related to the two patents are complex, the biological safety is unknown, and the nanoparticles with smaller particle size (<50nm) may have certain cytotoxicity and lack clinical application prospects. Therefore, methods for increasing the anti-infection of biological materials are still in need of improvement.
Disclosure of Invention
The invention aims to solve the technical problem of providing a slow-release anti-infection composite soft tissue repair material and a preparation method thereof. The medium containing anti-infection components is placed between or on the surface of the biological material layer at intervals according to the radius of the drug sensitive test inhibition zone, and is integrated by means of adhesive, suture or pressure. The invention can effectively and continuously release anti-infection components, does not change the biocompatibility of the biological material, is nontoxic and harmless, and has good clinical application prospect.
The invention relates to a slow-release anti-infection composite soft tissue repair material, which comprises a biological material and a medium containing anti-infection components.
The biomaterial is a single-layer, multi-layer or multi-component composite structure, and the medium containing anti-infection components is arranged between biomaterial layers or on the surface at intervals according to the radius of a bacteriostatic zone.
The radius of the zone of inhibition should be the minimum radius of the zone of inhibition within the effective time of the anti-infective ingredient, depending on the selected anti-infective ingredient, the application site, the indication and other factors, but the zone of inhibition should completely cover the layer of the medium containing the anti-infective ingredient.
The biomaterial is one or more of extracellular matrix/acellular matrix, collagen, fibrin, chitosan, chondroitin sulfate, hyaluronic acid, gelatin, P4HB and fibroin, and has good biocompatibility.
The extracellular matrix/acellular matrix is derived from the submucosa, basement membrane, dermis, pericardium, peritoneum, pleura or amnion of a hollow organ of a human or mammal, and the cross-linking degree of the material is 0-100%.
The medium containing the anti-infection component consists of the anti-infection component and the medium, and the anti-infection component is uniformly and stably distributed in the medium.
The anti-infection component is inorganic antibacterial agent and/or organic antibacterial agent.
The anti-infection component is one or more of nano silver, silver ions, bismuth, triclosan, chlorhexidine, bismuth compounds, antibiotics and antibacterial polypeptide.
The amount of the anti-infective ingredient added will depend on the use of the repair material, the conventional amount of anti-infective ingredient used, and the desired release profile of the anti-infective ingredient for use.
The medium is a three-dimensional interpenetrating network cross-linked structure, the components comprise one or more of extracellular matrix, collagen, fibrin, chitosan, hyaluronic acid, chondroitin sulfate, gelatin, polymer hydrogel and the like, the medium has the characteristics of degradability, plastic shape, biocompatibility, biosafety and the like, and the extracellular matrix gel is preferably selected.
The effective release time of the anti-infective ingredient in the composite soft tissue repair material is 1-48 days.
The invention relates to a preparation method of a slow-release anti-infection composite soft tissue repair material, which comprises the following steps: the method comprises the following steps: the biological material and the medium containing the anti-infection component are fixed into a whole through degradable suture bundling, adhesive bonding and vacuum lamination.
The method for fixing the biological material and the medium containing the anti-infective ingredient can be one or more selected from medical degradable suture bundling, medical adhesive bonding, vacuum lamination or other physical, chemical or biological methods capable of fixing the multi-layer material into a whole.
Advantageous effects
(1) Slow release, controlled release anti-infective ingredients: the medium provided by the invention is used as a delivery carrier of anti-infection components, and has the functions of slow release and controlled release. The medium is used as a delivery carrier of the drug, and is a solid or semisolid three-dimensional scaffold material which has a chemical or physical crosslinking structure, can be absorbed and is insoluble in water. The drug related to the invention can be in a liquid state and can be free in the gaps of a network structure, or can form covalent or non-covalent connection with molecules, and the drugs in the two states can reach certain dynamic equilibrium. After the implant is implanted into an organism, a large amount of medicines which are dissociated in a liquid state in gaps of a reticular structure are released at an early stage, host cells and tissues grow in a middle and later stage, a medium is slowly degraded, and meanwhile, the residual medicines are released continuously. In addition, the biological material is a three-dimensional network structure, has certain thickness, moisture permeability and porosity, is beneficial to exchange of nutrient components and oxygen and moisture of cells growing in the biological material, and can further play a role of slow release as a semipermeable membrane.
(2) The biological safety is good: the entrapment of the medium ensures that no large dose of antibacterial agent is directly exposed to organism tissues, and the spaced arrangement ensures that the medicine can be effectively released on the whole material, the use dose of the medicine is reduced while the effective medicine concentration is maintained, the area of direct contact between the medicine carrying medium and the organism is reduced, the histocompatibility and host-material immunoreaction types of the material are not changed, anaphylactic reaction is not caused, the toxicity and side effect can be further reduced, and the adverse reaction is reduced.
(3) The basic type of immune response of the host-material interface is not significantly changed: the anti-infection component is arranged between the biological material layers and does not directly contact with host tissues, the anti-infection component stamp sample is attached to the surface of the biological material, the ratio of the surface area of the antibacterial/biological material is smaller by the principle of the bacteriostatic zone, and the influence on the basic type of immune reaction of the host-material contact surface is reduced to the minimum.
Drawings
FIG. 1 is a schematic representation of the structure of a slow release anti-infective composite tissue repair material described in example 1; wherein 1 is biological material 2 is medium containing anti-infection component;
FIG. 2 results of in vitro bacteriostatic experiments (E.coli);
FIG. 3 results of in vitro bacteriostatic experiments (Staphylococcus aureus).
Detailed Description
The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Further, it should be understood that various changes or modifications of the present invention may be made by those skilled in the art after reading the teaching of the present invention, and such equivalents may fall within the scope of the present invention as defined in the appended claims.
Example 1
A tissue repairing material with medicine carrying and slow releasing function is prepared from the Small Intestine Submucosa (SIS) with cells removed, chitosan sheet, chitosan powder and antibacterial agent through mixing, dissolving and shaping to obtain sheet-shaped material, and preparing the SIS by cross splicing to obtain the tissue repairing material with area of 10 × 10cm2The tablet layer (2) is discontinuously paved on the SIS surface (1) according to the diameter of the inhibition zone with reference to fig. 1, and 6 tablets are paved. The layers are fixed by medical chitosan adhesive, and pressed into a whole under the pressure of 200 mmHg.
The bacteriostatic effect of the material in vitro is observed by a bacteriostatic loop method: has effective antibacterial activity against methicillin-resistant Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa and Escherichia coli for 7-21 days.
The cytotoxicity of the material was evaluated according to the method prescribed in GB/T16886.5. NIH3T3 and L929 were used as model cells. Cell culture medium is used as leaching medium, leaching liquor with gradient concentration is used for replacing culture medium to culture cells, and the cell survival rate is determined by MTT method. The cytotoxicity of the material is 0-I grade.
Constructing a canine model with abdominal wall defect accompanied by severe bacterial infection to repair materials. Animals were observed for 1, 3, 7, 14, 30 days after surgery without severe abdominal infection, and the bacterial numbers of the secretions were suppressed.
Claims (8)
1. A slow-release anti-infection composite soft tissue repair material, which is characterized in that: the repair material comprises a biological material and a medium containing an anti-infective component; wherein, the medium containing anti-infection components is arranged between the layers and/or on the surface of the biological material at intervals according to the radius of the bacteriostatic circle, and the periphery of the bacteriostatic circle is overlapped to ensure that the surface of the composite material is not missed.
2. The slow release, anti-infective composite soft tissue repair material of claim 1, wherein: the biomaterial is a single-layer, multi-layer or multi-component composite structure.
3. The slow release, anti-infective composite soft tissue repair material of claim 1, wherein: the biomaterial is one or more of extracellular matrix/acellular matrix, collagen, fibrin, chitosan, chondroitin sulfate, hyaluronic acid, gelatin, P4HB and fibroin.
4. The slow release, anti-infective composite soft tissue repair material of claim 1, wherein: the medium containing the anti-infective ingredient is composed of the anti-infective ingredient and the medium, and the anti-infective ingredient is distributed in the medium.
5. The slow release, anti-infective composite soft tissue repair material of claim 4, wherein: the anti-infection component is one or more of nano silver, silver ions, bismuth, triclosan, chlorhexidine, bismuth compounds, antibiotics and antibacterial polypeptide.
6. The slow release, anti-infective composite soft tissue repair material of claim 4, wherein: the medium is a three-dimensional interpenetrating network cross-linked structure, and the components of the medium comprise one or more of extracellular matrix, collagen, fibrin, chitosan, hyaluronic acid, chondroitin sulfate, gelatin and polymer hydrogel.
7. The slow release, anti-infective composite soft tissue repair material of claim 1, wherein: the effective release time of the anti-infective ingredient in the composite soft tissue repair material is 1-48 days.
8. A method of making a slow release anti-infective composite soft tissue repair material of any one of claims 1-7, comprising: the biological material and the medium containing the anti-infective ingredient are bound together by degradable sutures, adhesive bonding or vacuum lamination.
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| CN113908343B (en) * | 2021-09-30 | 2023-01-20 | 卓阮医疗科技（苏州）有限公司 | Biomaterial with improved bending performance |
| CN108653810B (en) * | 2018-05-28 | 2021-11-30 | 重庆科技学院 | Silk fibroin/gelatin interpenetrating network hydrogel capable of realizing cell encapsulation and preparation method thereof |
| CN111035806A (en) * | 2018-10-12 | 2020-04-21 | 上海市静安区闸北中心医院 | Anti-infection biological material and preparation method thereof |
| CN109847099B (en) * | 2018-11-22 | 2022-04-01 | 四川大学华西医院 | Multilayer soft tissue repair material and preparation method thereof |
| CN112451732A (en) * | 2020-11-27 | 2021-03-09 | 山东大学 | Silk fibroin antibacterial dressing with silver loaded on one side, and preparation method and application thereof |
| CN115282341B (en) * | 2022-06-27 | 2023-05-23 | 华南理工大学 | Porous metal material with polypeptide bidirectional gradient distribution surface and preparation method and application thereof |
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| CN85101396A (en) * | 1984-03-27 | 1987-01-31 | 新泽西州口腔医学院 | Can be by the lining matter of biological reduction of media and its method of production |
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