An tissue adhesion patch and its preparation method

Abstract

The present invention discloses a tissue adhesive patch and a preparation method thereof, which relates to the technical field of medical materials, and solves the technical problems that the existing tissue adhesives have insufficient adhesive force and poor mechanical properties; the present invention includes an adhesive layer and a reinforcing layer; the adhesive layer is coated on the surface of the reinforcing layer and photocured to form a tissue adhesive patch; the raw material of the reinforcing layer is a biodegradable polyester material; the raw materials of the adhesive layer include component A, component B, component C and component D; component A is a biodegradable polymer material; component B is acrylate or N-isopropylacrylamide; component C is acrylosuccinimide ester, and component D is a quaternary ammonium salt cationic monomer containing an unsaturated double bond; the present invention plays a role in enhancing and toughening the adhesive patch through the setting of the reinforcing layer, and at the same time improves the adhesive strength of the adhesive patch.

Description

Technical Field

[0001] The present invention relates to the technical field of medical materials, and particularly relates to a tissue adhesive patch and a preparation method thereof. Background Art

[0002] Clinically, the commonly used methods for repairing wounds or fistulas on the surface of visceral tissues include using tissue adhesives for adhesion or using staplers for anastomosis of fistulas. Commonly used tissue adhesives include α-cyanoacrylate, fibrin glue, etc. α-cyanoacrylate has strong adhesion, but after adhesion, it has high hardness, poor toughness, poor tissue mechanics matching, and poor biocompatibility, and is prone to produce toxic and side effects. The fibrin glue-based adhesive is an adhesive extracted from human plasma, mainly containing fibrinogen, thrombin, etc. Its curing reaction directly utilizes the body's own coagulation mechanism and finally generates a fibrin network with very strong adhesion, but there are problems such as poor wet surface adhesion, risk of immunogenicity and virus infection.

[0003] In the prior art, there are also some cases where hydrogels are used as adhesives for tissue adhesion repair. They have good biocompatibility and various forms can adapt to complex tissues, but it has been found in practice that hydrogel adhesives have insufficient adhesion and their mechanical properties cannot meet the use requirements. Summary of the Invention

[0004] The present invention aims to solve the technical problems that existing tissue adhesives have insufficient adhesion and poor mechanical properties, and aims to provide a tissue adhesive patch and a preparation method thereof. By setting an enhancement layer, the adhesive patch is enhanced and toughened, and at the same time, the adhesion strength of the adhesive patch is improved.

[0005] The present invention is achieved by the following technical solutions:

[0006] The first object of the present invention is to provide a tissue adhesive patch, which includes an adhesive layer and an enhancement layer;

[0007] The adhesive layer is coated on the surface of the enhancement layer and photocured to form a tissue adhesive patch;

[0008] The raw material of the enhancement layer is a biodegradable polyester material;

[0009] The raw materials of the adhesive layer include component A, component B, component C, and component D;

[0010] Component A is a biodegradable polymer material;

[0011] Component B is acrylate or N-isopropylacrylamide;

[0012] Component C is acrylate succinimidyl ester;

[0013] Component D is a quaternary ammonium salt cationic monomer containing an unsaturated double bond.

[0014] Further, component A is selected from any one or a combination of polyvinylpyrrolidone, polyvinyl alcohol, carboxymethyl cellulose, hydroxypropyl methyl cellulose, sodium alginate, gelatin, gum arabic, and tragacanth gum.

[0015] Further, component A is selected from any one or a combination of polyvinyl alcohol and polyvinylpyrrolidone.

[0016] Further, the acrylate esters are selected from any one or a combination of 2-hydroxyethyl methacrylate, 2-hydroxyethyl acrylate, and 2-hydroxybutyl acrylate.

[0017] Further, the acrylate esters are selected from 2-hydroxyethyl acrylate.

[0018] Further, the raw materials of the reinforcing layer are selected from any one or a combination of PLGA, PLA, PGA, PCL, PPDO, PHA, PHB, and PHV.

[0019] Further, component D is selected from any one or a combination of acryloyloxyethyl trimethyl ammonium chloride, methacryloyloxyethyl trimethyl ammonium chloride, methacrylamidopropyl trimethyl ammonium chloride, and alkyl allyl ammonium chloride.

[0020] Further, the adhesive layer further includes an active ingredient capable of loading and promoting tissue healing, and the active ingredient includes recombinant human epidermal growth factor, fibroblast growth factor, and vascular endothelial growth factor.

[0021] The second object of the present invention is to provide a method for preparing a tissue adhesive patch, comprising the following steps:

[0022] Dissolve the biodegradable polyester material in an organic solvent to form a biodegradable polyester solution; coat the biodegradable polyester solution on a template to form a layer of biodegradable polyester liquid film, and place the coated template in a vacuum drying oven for drying. After drying, a reinforcing layer is formed;

[0023] Dissolve the raw material components of the adhesive layer, component A biodegradable polymer material, component B acrylate ester or N-isopropylacrylamide, component C acrylsuccinimide ester, and component D quaternary ammonium salt cationic monomer containing an unsaturated double bond, in distilled water, add a water-soluble photoinitiator and stir to dissolve to form a prepolymer solution. Coat the prepolymer solution on the reinforcing layer and place it in an ultraviolet curing oven for curing for 0.5 - 3 h. After curing, a tissue adhesive patch is formed.

[0024] Further, the dissolution concentration of the degradable polyester material is 3%-20%, the dissolution concentration of component A is 5%-20%, the dissolution concentration of component B is 10%-35%, the dissolution concentration of component C is 3-15%, and the dissolution concentration of component D is 1%-15%.

[0025] Further, the addition amount of the water-soluble photoinitiator is 0.05-0.1% of the total mass of the solution, and the water-soluble photoinitiator is selected from α-hydroxy ketone-based water-soluble photoinitiators.

[0026] Compared with the prior art, the present invention has the following advantages and beneficial effects:

[0027] 1. The present invention copolymerizes acryloyl succinimide with substances such as acrylate or N-isopropylacrylamide and quaternary ammonium salt cationic monomers to form the main body of the adhesive, and forms an interpenetrating network structure with the degradable polymer material to enhance the cohesion of the main body of the adhesive. Acryloyl succinimide can react with amino groups on the tissue surface under physiological conditions to form strong amide covalent bonds; the introduction of quaternary ammonium salt cationic monomers can form strong electrostatic interactions with negatively charged functional groups on the tissue surface such as OH - 、COOO - etc. to provide non-covalent bonding adhesion, further improving the wet adhesion of the adhesive; at the same time, the polar groups in the degradable polymer material can also form strong hydrogen bonds and van der Waals forces with the tissue surface to provide partial adhesion, making the tissue adhesion patch provided by the present invention have stronger adhesion.

[0028] 2. The quaternary ammonium salt introduced in the tissue adhesion patch of the present invention has good broad-spectrum bactericidal properties, enabling the tissue adhesion patch to have certain antibacterial properties while having strong adhesion, and can effectively prevent wound infections.

[0029] 3. The present invention polymerizes and cures the adhesive prepolymer solution on the reinforcing layer under the action of ultraviolet light. The free radical polymerization reaction will cause some groups in the adhesive to graft onto the reinforcing layer, making the adhesive layer and the reinforcing layer firmly bonded together. Therefore, through the setting of the reinforcing layer, it plays a role in enhancing the mechanical strength and toughness of the adhesive layer, improving the mechanical properties of the patch. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] In order to more clearly illustrate the technical solutions of the exemplary embodiments of the present invention, the following will briefly introduce the drawings required for use in the embodiments. It should be understood that the following drawings only show some embodiments of the present invention, and therefore should not be regarded as limiting the scope. For those of ordinary skill in the art, without creative efforts, other related drawings can also be obtained based on these drawings. In the drawings:

[0031] Figure 1 Schematic diagram of the structure of the tissue adhesive patch of the present invention;

[0032] Figure 2 Product diagram of the tissue adhesive patch prepared in Example 5 of the present invention;

[0033] Figure 3 Lap-shear adhesion strength curve of the tissue adhesive patch prepared in Example 5 of the present invention;

[0034] Figure 4 Peel strength curve of the tissue adhesive patch prepared in Example 5 of the present invention. Detailed implementation manners

[0035] To make the objectives, technical solutions and advantages of the present invention clearer and more understandable, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments and the drawings. Obviously, the illustrative embodiments and descriptions of the present invention are only used to explain the present invention and are not intended to limit the present invention.

[0036] The following will appropriately refer to the drawings to detail the implementation manners of a tissue adhesive patch and its preparation method according to the present invention. However, there may be cases where unnecessary details are omitted. For example, there are cases where the detailed descriptions of well-known matters and repeated descriptions are omitted. This is to avoid the following descriptions from becoming unnecessarily lengthy and to facilitate the understanding of those skilled in the art.

[0037] The "range" disclosed in this application is defined in the form of a lower limit and an upper limit. A given range is defined by selecting a lower limit and an upper limit, and the selected lower limit and upper limit define the boundary of a specific range. The ranges defined in this way can include the end values or not include the end values, and can be combined arbitrarily, that is, any lower limit can be combined with any upper limit to form a range.

[0038] If there is no special description, all the implementation manners and optional implementation manners of this application can be combined with each other to form a new technical solution.

[0039] If there is no special description, all the technical features and optional technical features of this application can be combined with each other to form a new technical solution.

[0040] If there is no special description, the "including" and "comprising" mentioned in this application mean open-ended, and can also be closed-ended. For example, the "including" and "comprising" can mean that other substances not listed can also be included or comprised, or can only include or comprise the listed substances.

[0041] If there is no special description, all the steps of this application can be carried out in sequence or randomly, and preferably in sequence.

[0042] To solve the technical problems of insufficient adhesion and poor mechanical properties existing in existing tissue adhesives, the technical solution of the present invention is to provide a tissue adhesion patch with a structure as shown in Figure 1 shown, including an adhesive layer and a reinforcing layer;

[0043] The adhesive layer is coated on the surface of the reinforcing layer and photocured to form a tissue adhesion patch;

[0044] The raw material of the reinforcing layer is a degradable polyester material;

[0045] The raw materials of the adhesive layer include component A, component B, component C and component D;

[0046] Component A is a degradable polymer material;

[0047] Component B is acrylate or N-isopropylacrylamide;

[0048] Component C is acrylate succinimide ester;

[0049] Component D is a quaternary ammonium salt cationic monomer containing an unsaturated double bond.

[0050] The present invention copolymerizes acrylate succinimide ester with substances such as acrylate or N-isopropenylacrylamide and quaternary ammonium salt cationic monomer to form an adhesive main body, and forms an interpenetrating network structure with a degradable polymer material to enhance the cohesion of the adhesive main body. Acrylate succinimide ester can react with amino groups on the tissue surface under physiological conditions to form strong amide covalent bonds; the introduction of quaternary ammonium salt cationic monomer can form strong electrostatic interactions with negatively charged functional groups on the tissue surface such as OH - 、COOO - etc. to provide non-covalent bonding adhesion force, further improving the wet adhesion force of the adhesive; at the same time, polar groups in the degradable polymer material such as PVP can also form strong hydrogen bonds and van der Waals forces with the tissue surface to provide partial adhesion force.

[0051] The adhesive prepolymer solution polymerizes and cures on the reinforcing layer under the action of ultraviolet light. The free radical polymerization reaction will cause some groups in the adhesive to graft onto the reinforcing layer, making the adhesive layer and the reinforcing layer firmly bonded together. Specifically, under the action of an ultraviolet light initiator, the acrylate or quaternary ammonium salt cation monomer in the adhesive component reacts with the hydroxyl group in the reinforcing layer polyester through the free radical generated by the carbon-carbon double bond, so that the adhesive layer and the reinforcing layer are more firmly bonded together. Thus, through the setting of the reinforcing layer, the mechanical strength and toughness of the adhesive layer are enhanced, and the mechanical properties of the patch are improved. In actual use, the mechanical strength of the patch can be adjusted by adjusting the concentration of the reinforcing layer to meet the requirements of different tissues for mechanical strength and facilitate better fitting of the adhesive layer to the tissue.

[0052] The tissue adhesive patch provided by the present invention can be used for adhesion on the surface of wet tissues or on the surface of dry tissues after wetting the patch with water, and has a strong adhesive force. After the surface of the adhesive patch contacts water, the water is quickly absorbed by the water-absorbing component therein, causing the dry adhesive layer to form a viscous gel. At the same time, the water on the tissue surface is removed, which is beneficial to the reaction between the adhesive groups in the adhesive and the groups on the tissue surface to form strong adhesion.

[0053] The tissue adhesive patch of the present invention is applied to repair various tissue wounds or fistulas, such as the repair of skin surface wounds, as an adhesive patch for various visceral tissue wounds, such as the repair of heart, liver, kidney, and tubular tissue tears in the gastrointestinal tract and blood vessels. It can also be used in combination with repair tools such as intestinal staplers to reinforce the anastomosis. The patch has good mechanical flexibility and can adapt to the normal physiological peristalsis of tissues without being torn.

[0054] In one or more embodiments, the component A is selected from any one or more combinations of polyvinylpyrrolidone, polyvinyl alcohol, carboxymethyl cellulose, hydroxypropyl methyl cellulose, sodium alginate, gelatin, gum arabic, and tragacanth gum. Preferably, the component A is selected from any one or more combinations of polyvinyl alcohol and polyvinylpyrrolidone.

[0055] In one or more embodiments, the acrylates are selected from any one or more combinations of 2-hydroxyethyl methacrylate, 2-hydroxyethyl acrylate, and 2-hydroxybutyl acrylate. Preferably, the acrylates are selected from 2-hydroxyethyl acrylate.

[0056] In one or more embodiments, the raw material of the reinforcing layer is selected from any one or more combinations of PLGA, PLA, PGA, PCL, PPDO, PHA, PHB, and PHV.

[0057] In one or more embodiments, component D is selected from any one or more combinations of acryloyloxyethyl trimethyl ammonium chloride, methacryloyloxyethyl trimethyl ammonium chloride, methacrylamidopropyl trimethyl ammonium chloride, and alkyl allyl ammonium chloride.

[0058] To expand the functions of the tissue adhesive patch of the present invention, active ingredients promoting tissue healing, including but not limited to recombinant human epidermal growth factor, fibroblast growth factor, vascular endothelial growth factor, etc., can also be loaded during the preparation of the adhesive layer.

[0059] Based on the above tissue adhesive patch, the present invention also provides a method for preparing a tissue adhesive patch, comprising the following steps:

[0060] Dissolve the biodegradable polyester material in an organic solvent to form a clear and transparent solution with a concentration of 3% - 20%, preferably 5 - 10%, to form a biodegradable polyester solution; use a spin coater to coat the biodegradable polyester solution on a polytetrafluoroethylene template to form a layer of biodegradable polyester liquid film, and the spin coating parameters are: rotation speed 80 - 400 r / min, acceleration 20 - 100 m / s, spin coating time 10 - 40 s; then put the coated template into a vacuum drying oven for drying, and the drying parameters are: time 10 - 40 min, pressure -0.5 - 0.01 Mpa, temperature 30 - 80 °C; after drying, an enhanced layer is formed;

[0061] Dissolve the raw material components of the adhesive layer, component A biodegradable polymer material, component B acrylate or N-isopropylacrylamide, component C acryloyl succinimide ester, and component D quaternary ammonium salt cation monomer containing an unsaturated double bond, in distilled water to form a clear and transparent solution, add a water-soluble photoinitiator and stir to dissolve to form a prepolymer solution, use a spin coater to coat the prepolymer solution on the enhanced layer, and the spin coating parameters are: rotation speed 80 - 400 r / min, acceleration 20 - 100 m / s, spin coating time 10 - 40 s, put it into an ultraviolet curing oven (60 w, 365 nm) for curing for 0.5 - 3 h, and after curing, remove the formed film from the template to obtain the tissue adhesive patch.

[0062] In one or more embodiments, the dissolution concentration of the biodegradable polyester material is 3% - 20%, preferably 5 - 10%, the dissolution concentration of component A is 5% - 20%, the dissolution concentration of component B is 10% - 35%, the dissolution concentration of component C is 3 - 15%, and the dissolution concentration of component D is 1% - 15%. The organic solvent is selected from any one of hexafluoroisopropanol, ethyl formate, ethyl acetate, toluene, and dichloromethane.

[0063] In one or more embodiments, the addition amount of the water-soluble photoinitiator is 0.05-0.1% of the total mass of the solution. Specifically, the water-soluble photoinitiator is selected from α-hydroxy ketone-based waterborne photoinitiators, such as Irgacure 2959, Irgacure 651, etc., and Irgacure 2959 is preferred.

[0064] The technical solution of the present invention will be further described in detail below in conjunction with the embodiments.

[0065] It should be noted that the experimental methods used in the examples are all conventional methods unless otherwise specified. The materials, reagents, methods, and instruments used are all conventional materials, reagents, methods, and instruments in the art, and those skilled in the art can obtain them through commercial channels without special instructions.

[0066] Example 1

[0067] Preparation of the reinforcing layer

[0068] PCL was dissolved in dichloromethane to form a clear solution with a concentration of 8%. The PCL solution was coated on a polytetrafluoroethylene mold using a spin coater to form a PCL liquid film with a rotation speed of 80 r / min and a rotation time of 10 s. The spin-coated mold was placed in a vacuum drying oven and dried for 30 min to remove the dichloromethane solvent, obtaining a patch reinforcing layer with a thickness of 300 μm.

[0069] Example 2

[0070] Preparation of the reinforcing layer

[0071] PCL was dissolved in hexafluoroisopropanol to form a clear solution with a concentration of 10%. The PCL solution was coated on a polytetrafluoroethylene mold using a spin coater to form a PCL liquid film with a rotation speed of 100 r / min and a rotation time of 12 s. The spin-coated mold was placed in a vacuum drying oven and dried for 35 min to remove the hexafluoroisopropanol solvent, obtaining a patch reinforcing layer with a thickness of 200 μm.

[0072] Example 3

[0073] Preparation of the reinforcing layer

[0074] PCL was dissolved in hexafluoroisopropanol to form a clear solution with a concentration of 15%. The PCL solution was coated on a polytetrafluoroethylene mold using a spin coater to form a PCL liquid film with a rotation speed of 100 r / min and a rotation time of 15 s. The spin-coated mold was placed in a vacuum drying oven and dried for 40 min to remove the hexafluoroisopropanol solvent, obtaining a patch reinforcing layer with a thickness of 150 μm.

[0075] Example 4

[0076] Preparation of the reinforcing layer

[0077] Dissolve PLGA and PCL in hexafluoroisopropanol to form a mixed solution with a concentration of 10%, and the ratio of the two is PLGA:PCL = 3:7. Use a spin coater to coat the mixed solution on a polytetrafluoroethylene mold to form a liquid film with a rotation speed of 100 r / min and a rotation time of 12 s. The spin-coated mold is placed in a vacuum drying oven and dried for 35 min to remove the hexafluoroisopropanol solvent, thus obtaining the patch reinforcing layer with a thickness of 220 μm.

[0078] Example 5

[0079] Prepare the tissue adhesive patch using the product prepared in Example 1 as the patch reinforcing layer.

[0080] Dissolve each component raw material in distilled water to form a homogeneous prepolymer solution with concentrations of 10% polyvinylpyrrolidone, 10% 2-hydroxyethyl acrylate, 10% succinimidyl acrylate, 6% acryloyloxyethyl trimethyl ammonium chloride, and 0.5% Irgacure 651 initiator. The prepolymer solution is spin-coated onto the mold of the PLGA reinforcing layer. The reinforcing layer is placed under a 365 nm ultraviolet lamp for photocuring for 2 h, thus obtaining the tissue adhesive patch.

[0081] Example 6

[0082] Prepare the tissue adhesive patch using the product prepared in Example 1 as the patch reinforcing layer.

[0083] Dissolve each component raw material in distilled water to form a homogeneous prepolymer solution with concentrations of 15% polyvinyl alcohol, 15% 2-hydroxyethyl methacrylate, 12% succinimidyl acrylate, 8% methacrylamidopropyl trimethyl ammonium chloride, and 1.0% Irgacure 2959 initiator. The prepolymer solution is spin-coated onto the mold of the PCL reinforcing layer. The reinforcing layer is placed under a 365 nm ultraviolet lamp for photocuring for 1.5 h, thus obtaining the tissue adhesive patch.

[0084] Example 7

[0085] Prepare the tissue adhesive patch using the product prepared in Example 1 as the patch reinforcing layer.

[0086] Dissolve each component raw material in distilled water to form a homogeneous prepolymer solution with concentrations of 12% hydroxypropyl methylcellulose, 10% N-isopropylacrylamide, 5% succinimidyl acrylate, 10% dimethyldiallylammonium chloride, and 0.8% Irgacure 651 initiator. The prepolymer solution is spin-coated onto the mold of the PLGA reinforcing layer. The reinforcing layer is placed under a 365 nm ultraviolet lamp for photocuring for 1 h, thus obtaining the tissue adhesive patch with a thickness of 500 μm.

[0087] Comparative Example 1

[0088] The tissue adhesion patch was prepared by the method of Example 5, with the difference that component D was not contained in the composition of the adhesive layer.

[0089] Comparative Example 2

[0090] The tissue adhesion patch was prepared by the method of Example 5, with the difference that the reinforcing layer was not contained.

[0091] The performance of the tissue adhesion patches prepared in Examples 5 - 7 of the present invention and the comparative examples was tested, and the test results are shown in Table 1.

[0092] (1) Burst pressure test

[0093] Take a fresh pig small intestine that has been cleaned, about 15 cm in length. Clamp one end of the small intestine with surgical forceps, insert the other end into a silicone hose connected to CO2 gas and fix it with a cable tie. A high-precision pressure test gauge is installed on the silicone hose to test the burst pressure. Make a break about 2 mm x 2 mm in the middle of the small intestine, and cut the adhesion patch into a square of 10 mm x 10 mm. Wet the cut patch with physiological saline and attach it to the break of the small intestine. After pressing for 10 min, turn on the CO2 gas source, ventilate the small intestine at a speed of 2 mL / s, and record the maximum value of the pressure during the whole process as the burst pressure of the tissue patch.

[0094] (2) Lap-shear tensile strength test

[0095] Take fresh pigskin and degrease it according to Appendix 2. Cut the pigskin into a size of length x width x thickness = 60 mm x 25 mm x 2 mm, and cut the tissue patch into splines of the same length and width. Lap the front end 25 mm x 10 mm of the pigskin and the adhesive layer side of the tissue patch. After lapping, press for 30 min and test according to the method of ASTM F2255, collect data, and calculate the shear strength of the interface.

[0096] (3) Peel strength test, interface toughness

[0097] Take fresh pigskin and degrease it. Cut the pigskin into a size of length x width x thickness = 60 mm x 25 mm x 2 mm, and cut the tissue patch into splines of the same length and width. Bond the pigskin to the adhesive layer of the adhesion patch. After bonding, press for 30 min and test according to the method of ASTM F2256, collect data, and calculate the peel strength of the patch.

[0098] (4) Elongation at break

[0099] Cut the tissue adhesion patch into a size of 60mm x 25mm, clamp both ends of the patch with a fixture and fix it on a universal testing machine, stretch the patch at a speed of 5mm / min, record the elongation at the time of patch fracture, and calculate the elongation at break of the tissue patch.

[0100] (5) Antibacterial performance test

[0101] Take the leaching solution of the adhesive layer in physiological saline, and the test method refers to WS / T650-2019 for antibacterial performance test against Staphylococcus aureus.

[0102] Table 1. Test results of the performance of the tissue adhesion patches prepared in Examples 5-7 and Comparative Examples

[0103]

[0104] It can be seen from the data in Table 1 that the tissue adhesion patch prepared by the present invention has excellent adhesion strength and peel strength. Compared with the adhesion patch without a reinforcing layer, the mechanical properties of the patch are effectively improved, and after introducing quaternary ammonium salt into the tissue adhesion patch, its adhesiveness and antibacterial property are significantly improved.

[0105] Finally, it should be noted that: the above specific embodiments are only used to illustrate the purpose, technical solutions and beneficial effects of the present invention in detail. It should be understood that the above description is only the specific embodiments of the present invention and is not used to limit the protection scope of the present invention; although the present invention has been described in detail with reference to the above specific embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions recorded in the above embodiments, or perform equivalent substitution or improvement on some or all of the technical features; and these modifications, equivalent substitutions and improvements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be covered by the scope of the claims and the description of the present invention.

Claims

1. A tissue adhesive patch, characterized in that: including an adhesive layer and a reinforcing layer; The adhesive layer is coated on the surface of the reinforcement layer and light-cured to form a tissue adhesive patch; The raw material of the reinforcing layer is a degradable polyester material, and the degradable polyester material is selected from any one or more combinations of PLGA, PLA, PGA, PCL, PPDO, PHA, PHB and PHV; The raw materials of the adhesive layer include component A, component B, component C and component D; The component A is selected from any one or more combinations of polyvinyl pyrrolidine, polyvinyl alcohol, carboxymethyl cellulose, hydroxypropyl methyl cellulose, sodium alginate, gelatin, gum arabic, and gum tragacanth; The component B is acrylate or N-isopropylacrylamide; The component C is succinimidyl acrylate; The component D is selected from any one or more combinations of acryloyloxyethyl trimethyl ammonium chloride, methacryloyloxyethyl trimethyl ammonium chloride, methacrylamide propyl trimethyl ammonium chloride and alkyl allyl ammonium chloride.

2. A tissue adhesive patch according to claim 1, characterized in that: The component A is selected from any one or more combinations of polyvinyl alcohol and polyvinyl pyrrolidone.

3. A tissue adhesive patch according to claim 1, characterized in that: The acrylic esters are selected from any one or more combinations of hydroxyethyl methacrylate, hydroxyethyl acrylate, and hydroxybutyl acrylate.

4. A tissue adhesive patch according to claim 3, characterized in that: The acrylic acid esters are selected from hydroxyethyl acrylate.

5. A tissue adhesive patch according to any one of claims 1 to 4, characterized in that: The adhesive layer also includes active ingredients that promote tissue healing, including recombinant human epidermal growth factor, fibroblast growth factor, and vascular endothelial cell growth factor.

6. A method for preparing a tissue adhesive patch according to any one of claims 1 to 5, comprising the following steps: Dissolving a degradable polyester material in an organic solvent to form a degradable polyester solution; coating the degradable polyester solution on a template to form a layer of degradable polyester liquid film; placing the coated template in a vacuum drying oven for drying, and forming a reinforcement layer after drying; The raw materials of the adhesive layer, component A, a degradable polymer material, component B, acrylate or N-isopropylacrylamide, component C, succinimidyl acrylate, and component D, a quaternary ammonium salt cationic monomer containing an unsaturated double bond, are dissolved in distilled water, a water-soluble photoinitiator is added and stirred to dissolve to form a prepolymer solution, the prepolymer solution is coated on the reinforcement layer, and the solution is placed in a UV curing box for curing for 0.5-3 hours, and a tissue adhesive patch is formed after curing.

7. The method for preparing a tissue adhesive patch according to claim 6, characterized in that: The dissolution concentration of the degradable polyester material is 3%-20%, the dissolution concentration of the component A is 5%-20%, the dissolution concentration of the component B is 10%-35%, the dissolution concentration of the component C is 3-15%, and the dissolution concentration of the component D is 1%-15%.

8. The method for preparing a tissue adhesive patch according to claim 6, characterized in that: The amount of the water-soluble photoinitiator added is 0.05-0.1% of the total mass of the solution, and the water-soluble photoinitiator is selected from α-hydroxyketone water-based photoinitiators.

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