Radiation sterilization resistant silicone gel dressing and its preparation method and application

Abstract

The application belongs to the technical field of medical dressings and relates to a radiation-resistant sterilization silicone gel dressing which is widely applied in wound self-repair, scar inhibition, pressure reduction, antibiosis, deodorization, hemostasis, foam dressing, eye patch, scar patch, fixing belt and the like. The radiation-resistant sterilization silicone gel dressing comprises a release layer, a porous silicone gel layer, an absorption layer and a water-blocking layer, and each layer is integrated by bonding and heat sealing process and is prepared by die cutting. The porous silicone gel layer has radiation resistance. By controlling the ratio of silicon hydrogen groups to silicon vinyl groups in the system to be between 0.35 and 0.85, first, a component A is prepared by taking methyl phenyl vinyl silicone oil, end vinyl silicone oil, MDTQ methyl phenyl vinyl silicone resin and a catalyst as main raw materials; then, a component B is prepared by taking methyl phenyl vinyl silicone oil, end vinyl silicone oil, MDTQ methyl phenyl vinyl silicone resin, a crosslinking agent, a chain extender and an inhibitor as main raw materials; finally, the component A and the component B are mixed in proportion, and the radiation-resistant sterilization silicone gel dressing is prepared by coating and punching.

Description

Technical Field

[0001] This invention belongs to the field of medical dressing technology, and relates to silicone gel dressings, particularly to a radiation-resistant sterilizable silicone gel dressing and its preparation method and application. Background Technology

[0002] Silicone gel is a transparent self-adhesive adhesive with excellent properties such as cushioning and shock absorption, self-healing, self-adhesion, moisture-proof sealing, resistance to thermal shock, electrical insulation, and non-toxicity. Therefore, it is widely used in the field of medical devices to ensure their self-adhesion and self-healing properties.

[0003] The silicone gel system prepared by existing technology will further crosslink after irradiation sterilization, which will increase the degree of crosslinking, resulting in a significant decrease in the peel strength of the silicone gel and a decrease in adhesion, affecting the clinical use effect and making it unsuitable for widespread use in irradiation sterilization.

[0004] Silicone gel is typically a solid-liquid coexisting gel material formed by crosslinking a vinyl polysiloxane base with a hydrogen-containing polysiloxane as a crosslinking agent in the presence of a catalyst through a hydrosilylation reaction. It is then coated and perforated to form silicone gel rolls, which are later used in silicone gel dressings.

[0005] Existing silicone gel dressings are typically sterilized with ethylene oxide, which has a long desorption period (14 days for standard desorption). Clinical use is only permitted after passing tests for ethylene oxide residue, significantly extending product delivery times and increasing clinical risks. The absorbent layer in silicone gel dressings generally has a porous structure and a certain thickness, making it prone to absorbing and retaining ethylene oxide gas. Therefore, thorough desorption after sterilization is necessary to ensure its biosafety. Summary of the Invention

[0006] Based on this, the purpose of the present invention is to provide a radiation-resistant sterilizable silicone gel dressing, which has wide applications in wound self-healing, scar inhibition, pressure reduction, antibacterial, deodorizing, hemostasis, foam dressing, eye patch, scar patch, fixation bandage, etc.

[0007] To achieve the above objectives, the present invention adopts the following technical solution:

[0008] This invention provides a radiation-resistant sterilizable silicone gel dressing, comprising a release layer, a porous silicone gel layer, an absorbent layer, and a water-resistant layer. The layers are bonded together using adhesive and heat-sealing processes, and then die-cut to obtain the dressing. Its key features include radiation resistance, good tackiness after radiation sterilization, and a peel strength remaining at 0.3-0.5 N / cm; liquid absorption capacity >10 times; and a water vapor transmission rate of 5000-10000 g / (m²). 2 24h), liquid absorption capacity > 20g / 48h.

[0009] The porous silicone gel layer possesses radiation resistance and has any one of the following small pore structures: circular, elliptical, or square. By controlling the ratio of silane groups to vinyl groups in the reaction system to be between 0.35 and 0.85, component A is first prepared by reacting methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, and a catalyst as main raw materials in a specific ratio. Then, component B is prepared by reacting methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, a crosslinking agent, a chain extender, and an inhibitor as main raw materials in a specific ratio. Finally, component A and component B are mixed in a specific ratio and then coated and perforated to obtain the final product.

[0010] Further, the methylphenyl vinyl silicone oil is a divinyl-terminated methylphenyl silicone oil with a phenyl molar content of 5%-60%, a vinyl content of 0.01-0.1 mol / 100g, and a viscosity between 500-5000 mPa·s; possessing any one of the following structural formulas, where a, b, and c are integers ≥1.

[0011] A

[0012] B

[0013] C.

[0014] Furthermore, the vinyl-terminated silicone oil is a divinyl-terminated polydimethylsiloxane with a viscosity between 10,000 and 200,000 mPa·s, including any one of vinyl-terminated silicone oils of single viscosity or mixtures of vinyl-terminated silicone oils of different viscosities.

[0015] Furthermore, the viscosity of the MDTQ methylphenyl vinyl silicone resin is between 1000 and 20000 mPa·s, and the vinyl content is 0.01-0.5 mol / 100g.

[0016] Further, the crosslinking agent is a hydrogen-containing silicone oil with a hydrogen content not exceeding 0.15%, including at least one of methyl hydrogen-containing silicone oil and phenyl hydrogen-containing silicone oil; possessing any one of the following structural formulas, wherein in chemical formula D, a is an integer ≥0 and b is an integer ≥3; in chemical formula E, a is an integer ≥3 and b is an integer ≥1; in chemical formula F, a is an integer ≥3 and b is an integer ≥1.

[0017] D

[0018] E

[0019] F.

[0020] Furthermore, the chain extender is a hydrogen-terminated silicone oil, each molecule containing at least two silane groups, with a hydrogen content not exceeding 0.2%, including one or both of methyl hydrogen-terminated silicone oil and phenyl hydrogen-terminated silicone oil; possessing any one of the following structural formulas, where a is an integer ≥ 0 and b is an integer ≥ 1.

[0021] G

[0022] H.

[0023] Further, the inhibitor includes any one or more of ethynyl alcohols, vinylcyclosiloxanes, maleate esters, and amine compounds; wherein ethynyl alcohols include any one of 3-methyl-1-butyn-3-ol, 1-ethynyl-1-cyclohexanol, 3-phenyl-1-butyn-3-ol, and 3-octyl-1-butyn-3-ol; and vinylcyclosiloxanes include any one of 2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane and 1,1,3,3-tetramethyl-1,3-divinylsiloxane.

[0024] Furthermore, the platinum catalyst comprises any one or more of the following: platinum compounds soluble in polyorganosiloxanes, platinum-olefin complexes, platinum-cyclopropane complexes, alcoholic solutions of hexachloroplatinic acid, platinum catalysts coordinated with tetrahydrofuran, and platinum-vinylsiloxane complexes.

[0025] Furthermore, the absorbent layer is a single-layer or multi-layer composite material structure, including any one or more of polyurethane foam, activated carbon fiber, graphene antibacterial fiber, polypropylene fiber, chitosan fiber, and calcium alginate fiber.

[0026] This invention also provides a method for preparing a radiation-resistant sterilizable silicone gel dressing, characterized by comprising the following steps:

[0027] Step A: Preparation of radiation-resistant silicone gel compound: Component A is prepared by mixing methyl phenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methyl phenyl vinyl silicone resin, and catalyst in a certain proportion and stirring until homogeneous; Component B is prepared by mixing methyl phenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methyl phenyl vinyl silicone resin, crosslinking agent, chain extender, and inhibitor in a certain proportion and stirring until homogeneous.

[0028] Furthermore, the MDTQ methylphenyl vinyl silicone resin can be a silicone resin dispersion, which is formed by dispersing the MDTQ methylphenyl vinyl silicone resin into methylphenyl vinyl silicone oil and / or terminal vinyl silicone oil.

[0029] Further, in step A, the molar ratio of hydroxyl groups to vinyl groups in the system is controlled to be between 0.35 and 0.85. Component A includes the following components (by weight): 10-40 parts of methylphenyl vinyl silicone oil, 30-75 parts of terminal vinyl silicone oil, 1-10 parts of MDTQ methylphenyl vinyl silicone resin, and 0.01-1 parts of catalyst; Component B includes the following components (by weight): 5-15 parts of methylphenyl vinyl silicone oil, 20-90 parts of terminal vinyl silicone oil, 1-10 parts of MDTQ methylphenyl vinyl silicone resin, 10-20 parts of crosslinking agent, 1-10 parts of chain extender, and 0.01-1 parts of inhibitor.

[0030] Step B: Processing of the porous silica gel layer: Mix component A and component B prepared in step A at a mass ratio of 1-3:1-4, stir thoroughly until homogeneous, and then coat using a coating machine. The processing temperature is 50℃-200℃, and the coating amount is 100-1000 g / m². 2 No primer is needed during coating; it can be directly coated and has good adhesion to the substrate.

[0031] Step C: Preparation of Radiation-Resistant Sterilizable Silicone Gel Dressing: The release layer, the porous silicone gel layer prepared in Step B, the absorbent layer, and the water-blocking layer are bonded together using adhesive and heat sealing processes. After die-cutting and irradiation sterilization, the dressing is prepared. If the absorbent layer has a multi-layered structure, the layers are bonded together as a single unit without any adhesive between them. Electron beam sterilization is used, with an irradiation dose of 8kGy-25kGy. Under suitable conditions, X-ray or gamma-ray irradiation sterilization can also be used.

[0032] This invention also provides an application of radiation-resistant sterilizable silicone gel dressing in wound self-healing, scar inhibition, pressure reduction, antibacterial, deodorizing, and hemostatic applications.

[0033] This invention also provides an application of radiation-resistant sterilizable silicone gel dressing in silicone gel foam dressings, eye patches, scar patches, and silicone gel fixation bandages.

[0034] The beneficial effects of the invention are:

[0035] 1. The radiation-resistant silicone gel material in this radiation-resistant silicone gel dressing is prepared by hydrosilylation addition reaction using silicone oils containing delocalized large π-bond structures, such as methylphenyl vinyl silicone oil, phenyl side-hydrogen silicone oil, and phenyl terminal hydrogen silicone oil. The delocalized large π-bonds in the benzene ring conjugated structure can disperse the absorbed radiation energy, allowing the excitation energy to be transferred between or within molecules, thereby avoiding the breaking of chemical bonds. As a result, the radiation resistance of the material is improved, making the silicone gel suitable for radiation sterilization in medical device applications.

[0036] 2. The radiation-resistant silicone gel preparation process provided by this invention effectively controls the crosslinking density of the silicone gel by controlling the ratio of silanol groups to vinyl silane groups in the silicone gel system between 0.35 and 0.85, and by adding reinforcing silicone resin. This results in increased strength after curing while maintaining good tack. After irradiation sterilization, it exhibits good tack and minimal decrease in peel strength, remaining at 0.3-0.5 N / cm.

[0037] 3. Compared with existing silicone gel dressings, the significant advantage of the radiation-resistant silicone gel dressing provided by this invention is that it can be sterilized by radiation, which greatly improves the sterilization efficiency. Compared with existing ethylene oxide sterilization technology, the sterilized product does not have the problems of ethylene oxide residue and long desorption cycle (generally 2 weeks).

[0038] 4. The absorption layer of this radiation-resistant silicone gel dressing is a single-layer or multi-layer composite material structure. In addition to meeting the basic requirements of moist wound healing theory, it also has the functions of absorbing a large amount of exudate, reducing pressure, antibacterial, deodorizing, and vertical absorption and anti-permeability. Detailed Implementation

[0039] The present invention will be further described in detail below with reference to embodiments, but the implementation of the present invention is not limited thereto. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention. Example 1

[0040] A radiation-resistant silicone gel dressing is prepared using the following steps:

[0041] (1) Preparation of radiation-resistant silicone gel: The selection of each raw material component is shown in Table 1 and Table 2, and it is prepared according to the following method:

[0042] Group A partitioning: Methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, and diethylenetetramethyldisiloxane platinum complex were mixed in proportion and added to a dual planetary stirrer for stirring and dispersion. The mixture was obtained after 180 min.

[0043] Group B formulation: Methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, crosslinking agent, chain extender, and inhibitor are added to a dual planetary mixer in the specified proportions and mixed for 180 minutes to obtain the final product.

[0044] (2) Processing of porous silica gel layer:

[0045] Mix components A and B of the radiation-resistant silicone gel at a 1:1 mass ratio, stir thoroughly, and apply to the substrate at a coating weight of 200 g / m². 2Curing temperature 150℃, then winding; set the punching machine parameters, punch and wind to obtain a porous, radiation-resistant silicone gel.

[0046] (3) The release layer, porous silicone gel layer, absorbent layer, and water-blocking layer are composited. The porous silicone gel roll, polyurethane foam roll, polypropylene fiber roll, chitosan fiber roll, activated carbon fiber roll, adhesive-coated polyurethane film, and release layer are composited and die-cut on a dressing die-cutting machine to form a radiation-resistant silicone gel dressing. No adhesive is added between the layers of the absorbent layer.

[0047] (4) Pack and seal the radiation-resistant silicone gel dressing, and sterilize it under a 10kGy irradiation dose to obtain the product. Example 2

[0048] A radiation-resistant silicone gel dressing is prepared using the following steps:

[0049] (1) Preparation of radiation-resistant silicone gel: The selection of each raw material component is shown in Table 1 and Table 2, and it is prepared according to the following method:

[0050] Group A mixture: Methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, and diethylenetetramethyldisiloxane platinum complex were mixed in proportion and added to a dual planetary stirrer for stirring and dispersion. The mixture was obtained after 150 minutes.

[0051] Group B formulation: Methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, crosslinking agent, chain extender, and inhibitor are added to a dual planetary mixer in the specified proportions and mixed for 150 minutes to obtain the final product.

[0052] (2) Processing of porous silica gel layer:

[0053] Mix components A and B of the radiation-resistant silicone gel at a mass ratio of 1:2, stir thoroughly, apply to the substrate with a coating amount of 150 g / m2, cure at 170℃, and then roll up. Set the parameters of the punching machine, punch holes, and roll up to obtain a perforated radiation-resistant silicone gel roll.

[0054] (3) The release layer, porous silicone gel layer, absorbent layer, and water-blocking layer are compositely molded. The porous silicone gel roll, polyurethane foam roll, polypropylene fiber roll, coated polyurethane film, and release layer are compositely die-cut on a dressing die-cutting machine to form a radiation-resistant silicone gel dressing. No adhesive is added between the layers of the absorbent layer.

[0055] (4) Pack and seal the radiation-resistant silicone gel dressing, and sterilize it under an irradiation dose of 15 kGy to obtain the product. Example 3

[0056] A radiation-resistant silicone gel dressing is prepared using the following steps:

[0057] (1) Preparation of radiation-resistant silicone gel: The selection of each raw material component is shown in Table 1 and Table 2, and it is prepared according to the following method:

[0058] Group A mixture: Methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, and diethylenetetramethyldisiloxane platinum complex were mixed in proportion and added to a dual planetary stirrer for stirring and dispersion. The mixture was obtained after 120 minutes.

[0059] Group B mixing method: Methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, crosslinking agent, chain extender, and inhibitor are added to a dual planetary mixer in proportion and mixed for 120 minutes to obtain the final product.

[0060] (2) Processing of porous silica gel layer:

[0061] Mix components A and B of the radiation-resistant silicone gel at a mass ratio of 3:1, stir thoroughly, and apply to the substrate with a coating weight of 110 g / m². 2 Curing temperature 150℃, then winding; set the punching machine parameters, punch and wind to obtain perforated radiation-resistant silicone gel roll material.

[0062] (3) The release layer, porous silicone gel layer, absorbent layer, and water-blocking layer are compositely molded. The porous silicone gel roll, polyurethane foam roll, polypropylene fiber roll, coated polyurethane film, and release layer are compositely die-cut on a dressing die-cutting machine to form a radiation-resistant silicone gel dressing. No adhesive is added between the layers of the absorbent layer.

[0063] (4) Pack and seal the radiation-resistant silicone gel dressing, and sterilize it under a 20kGy irradiation dose to obtain the product. Example 4

[0064] A radiation-resistant silicone gel dressing is prepared using the following steps:

[0065] (1) Preparation of radiation-resistant silicone gel: The selection of each raw material component is shown in Table 1 and Table 2, and it is prepared according to the following method:

[0066] Group A mixture: Methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, and diethylenetetramethyldisiloxane platinum complex were mixed in proportion and added to a dual planetary stirrer for stirring and dispersion. The mixture was obtained after 160 min.

[0067] Group B mixing method: Methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, crosslinking agent, chain extender, and inhibitor are added to a dual planetary mixer in proportion and mixed for 160 minutes to obtain the final product.

[0068] (2) Processing of porous silica gel layer:

[0069] Mix components A and B of the radiation-resistant silicone gel at a mass ratio of 2:1, stir thoroughly, apply to the substrate with a coating amount of 130 g / m2, cure at 120℃, and then roll up. Set the parameters of the punching machine, punch holes, and roll up to obtain a perforated radiation-resistant silicone gel roll.

[0070] (3) The release layer, porous silicone gel layer, absorbent layer and water-blocking layer are compositely molded. The porous silicone gel roll, polyurethane foam roll, chitosan fiber roll, adhesive polyurethane film and release layer are compositely die-cut on a dressing die-cutting machine to form a radiation-resistant silicone gel dressing. No adhesive is added between the layers of the absorbent layer.

[0071] (4) Pack and seal the radiation-resistant silicone gel dressing, and sterilize it under a 20kGy irradiation dose to obtain the product. Example 5

[0072] A radiation-resistant silicone gel dressing is prepared using the following steps:

[0073] (1) Preparation of radiation-resistant silicone gel: The selection of each raw material component is shown in Table 1 and Table 2, and it is prepared according to the following method:

[0074] Group A formulation: Methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, and diethylenetetramethyldisiloxane platinum complex were mixed in proportion and added to a dual planetary stirrer for stirring and dispersion. The mixture was obtained after 200 minutes.

[0075] Group B mixing method: Methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, crosslinking agent, chain extender, and inhibitor are added to a dual planetary mixer in proportion and mixed for 200 minutes to obtain the final product.

[0076] (2) Processing of porous silica gel layer:

[0077] Mix components A and B of the radiation-resistant silicone gel at a 1:1 mass ratio, stir thoroughly, apply to the substrate at a coating weight of 170 g / m², cure at 180°C, and then roll up. Set the parameters of the punching machine, punch holes, and roll up to obtain a perforated radiation-resistant silicone gel roll.

[0078] (3) The release layer, porous silicone gel layer, absorbent layer, and water-blocking layer are compositely molded. The porous silicone gel roll, polyurethane foam roll, polypropylene fiber roll, graphene antibacterial fiber, adhesive-coated polyurethane film, and release layer are compositely die-cut on a dressing die-cutting machine to form a radiation-resistant silicone gel dressing. No adhesive is added between the layers of the absorbent layer.

[0079] (4) Pack and seal the radiation-resistant silicone gel dressing, and sterilize it under a 10kGy irradiation dose to obtain the product.

[0080] Table 1. Selection and dosage of raw materials for component A of the radiation-resistant silicone gel in Examples 1-5

[0081]

[0082] Table 2. Selection and dosage of raw materials for component B of the radiation-resistant silicone gel in Examples 1-5

[0083]

[0084] Comparative Example 1 and Comparative Example 2

[0085] A silicone gel dressing, the preparation steps are as follows:

[0086] (1) Preparation of silicone gel material: The difference from the example is that methyl phenyl vinyl silicone oil was not added to the system. The selection of each raw material component is shown in Table 3, and it is prepared according to the following method.

[0087] Group A formulation: High-viscosity vinyl-terminated silicone oil, low-viscosity vinyl-terminated silicone oil, MDTQ methylphenyl vinyl silicone resin, and diethylenetetramethyldisiloxane platinum complex are mixed in proportion and added to a dual planetary stirrer for stirring and dispersion. The mixture is obtained after 200 minutes.

[0088] Group B mixing method: High viscosity vinyl-terminated silicone oil, low viscosity vinyl-terminated silicone oil, MDTQ methyl phenyl vinyl silicone resin, crosslinking agent, chain extender, and 1-ethynyl-1-cyclohexanol are added to a dual planetary stirrer in the specified proportions and mixed for 200 minutes to obtain the final product.

[0089] (2) Processing of the silica gel layer:

[0090] Mix components A and B of the silicone gel compound at a 1:1 mass ratio, stir thoroughly, and apply to the substrate at a coating weight of 120 g / m². 2 Curing temperature 170℃, then winding; set the punching machine parameters, punch and wind to obtain perforated silicone gel roll material.

[0091] (3) The release layer, silicone gel layer, absorbent layer, and water-resistant layer are compositely molded. The porous silicone gel roll, polyurethane foam roll, polypropylene fiber roll, coated polyurethane film, and release layer are compositely die-cut on a dressing die-cutting machine to form a silicone gel dressing. No adhesive is added between the layers of the absorbent layer.

[0092] (4) The silicone gel dressing is packaged and sealed, and sterilized under a 10kGy irradiation dose to obtain the product.

[0093] Table 3. Raw material selection and dosage of silicone gel compounds in Comparative Examples 1 and 2

[0094]

[0095] Performance testing

[0096] (1) Referring to the method in YY / T 1293.2-2022, the performance of the radiation-resistant silicone gel dressings prepared in Examples 1-5 before and after irradiation sterilization was tested. The test results are shown in Table 4 below.

[0097] Table 4. Performance test results of the radiation-resistant silicone gel dressings prepared in Examples 1-5

[0098] test Example 1 Example 2 Example 3 Example 4 Example 5 Silicon-hydrogen / silicon vinyl molar ratio 0.55 0.54 0.55 0.53 0.54 Liquid absorption (before) 10.1 10.3 10 10.6 10.2 Liquid absorption (after) 10.2 10 10.1 10.2 10 Liquid permeation (48h) 20.5 20.3 20.5 20.4 20.5 Liquid permeation rate after 48 hours 20.5 20.1 20.4 20 20.3 Water vapor transmission rate (front) 14700 14760 14800 14690 14701 Water vapor transmission rate (after) 147800 14745 14820 14700 14688 Water resistance (front) qualified qualified qualified qualified qualified Water resistance (after) qualified qualified qualified qualified qualified Heavy metal content (front) qualified qualified qualified qualified qualified Heavy metal content (later) qualified qualified qualified qualified qualified pH (before) qualified qualified qualified qualified qualified pH (after) qualified qualified qualified qualified qualified

[0099] (2) Referring to the method in YY / T 1293.2-2022, the peel strength of the silicone gel dressings prepared in Examples 1-5 and Comparative Examples 1-2 before and after irradiation sterilization was tested. The test results are shown in Table 5 below.

[0100] Table 5 shows the peel strength test results of the dressings before and after irradiation sterilization obtained in Examples 1-5 and Comparative Examples 1-2.

[0101] test Example 1 Example 2 Example 3 Example 4 Example 5 Comparative Example 1 Comparative Example 2 Peel strength (N / cm) (front) 0.45 0.43 0.44 0.45 0.42 0.44 0.43 Peel strength (N / cm) (after peel) 0.4 0.39 0.41 0.38 0.37 0.16 0.15

[0102] As can be seen from Table 4, the radiation-resistant silicone gel dressing prepared by the method provided in this invention maintains stable performance before and after irradiation, especially with a liquid absorption capacity >10 times and a water vapor transmission rate of 5000-10000 g / (m²). 2 24h), liquid absorption capacity > 20g / 48h.

[0103] As shown in Table 5, the peel strength of the silicone gel dressing prepared in the comparative example decreased by about 65% after irradiation sterilization, severely affecting the adhesiveness of the dressing. The method for preparing the radiation-resistant silicone gel dressing provided by this invention, by controlling the molar ratio of silanol groups to vinyl silane groups in the system between 0.35 and 0.85, and by adding methylphenyl vinyl silicone oil, phenyl hydrogen silicone oil, and MDTQ methylphenyl vinyl silicone resin to the system, can improve the radiation resistance of the silicone gel. After irradiation sterilization, the adhesiveness is good, and the peel strength decreases only slightly, remaining at 0.3-0.5 N / cm. Its radiation resistance mechanism lies in the fact that the delocalized large π bonds in the benzene ring conjugated structure can disperse the absorbed radiation energy, allowing the excitation energy to transfer between or within molecules, thereby avoiding the breaking of chemical bonds, thus improving the radiation resistance of the material.

[0104] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A radiation-resistant sterilization silicone gel dressing, comprising a release layer, a porous silicone gel layer, an absorbent layer, and a water-resistant layer, wherein the layers are bonded together by adhesive and heat-sealing processes, and then die-cut to obtain the dressing, characterized in that... It exhibits radiation resistance, with a peel strength remaining at 0.3-0.5 N / cm; liquid absorption capacity >10 times; and water vapor transmission rate of 5000-10000 g / (m²). 2 .24h), liquid permeation >20g / 48h; The porous silicone gel layer possesses radiation resistance and has any one of the following small pore structures: circular, elliptical, or square. By controlling the molar ratio of silane groups to vinyl groups in the reaction system to be between 0.35 and 0.85, component A is first prepared by reacting methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, and a catalyst as main raw materials in a specific ratio. Then, component B is prepared by reacting methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, a crosslinking agent, a chain extender, and an inhibitor as main raw materials in a specific ratio. Finally, component A and component B are mixed in a specific ratio, coated, and perforated to obtain the final product. The crosslinking agent is a side-containing hydrogen silicone oil, including at least one of methyl hydrogen silicone oil and phenyl hydrogen silicone oil. The chain extender is a terminal hydrogen silicone oil, including one or both of methyl hydrogen silicone oil and phenyl hydrogen silicone oil. The crosslinking agent is a hydrogen-containing silicone oil with a hydrogen content not exceeding 0.15%, including at least one of methyl hydrogen-containing silicone oil and phenyl hydrogen-containing silicone oil; it possesses any one of the following structural formulas, wherein in chemical formula D, a is an integer ≥0 and b is an integer ≥3; in chemical formula E, a is an integer ≥3 and b is an integer ≥1; in chemical formula F, a is an integer ≥3 and b is an integer ≥1. ； The chain extender is a hydrogen-terminated silicone oil, each molecule containing at least two silane groups, with a hydrogen content not exceeding 0.2%, including one or both of methyl hydrogen-terminated silicone oil and phenyl hydrogen-terminated silicone oil; possessing any one of the following structural formulas, where a is an integer ≥ 0 and b is an integer ≥ 1. 。 2. The radiation-resistant sterilizable silicone gel dressing according to claim 1, characterized in that, The methylphenyl vinyl silicone oil is a divinyl-terminated methylphenyl silicone oil with a phenyl molar content of 5%-60%, a vinyl content of 0.01-0.1 mol / 100g, and a viscosity between 500-5000 mPa·s; it possesses any one of the following structural formulas, where a, b, and c are integers ≥1. 。 3. The radiation-resistant sterilizable silicone gel dressing according to claim 1, characterized in that, The vinyl-terminated silicone oil is a divinyl-terminated polydimethylsiloxane with a viscosity between 10,000 and 200,000 mPa·s, including any one of vinyl-terminated silicone oils of single viscosity or mixtures of vinyl-terminated silicone oils of different viscosities.

4. The radiation-resistant sterilizable silicone gel dressing according to claim 1, characterized in that, The viscosity of the MDTQ methylphenyl vinyl silicone resin is between 1000-20000 mPa·s, and the vinyl content is 0.01-0.5 mol / 100g.

5. The radiation-resistant sterilizable silicone gel dressing according to claim 1, characterized in that, The inhibitors include any one or more of ethynyl alcohols, vinylcyclosiloxanes, maleate esters, and amine compounds; wherein ethynyl alcohols include any one of 3-methyl-1-butyn-3-ol, 1-ethynyl-1-cyclohexanol, 3-phenyl-1-butyn-3-ol, and 3-octyl-1-butyn-3-ol; and vinylcyclosiloxanes include any one of 2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane and 1,1,3,3-tetramethyl-1,3-divinylsiloxane.

6. The radiation-resistant sterilizable silicone gel dressing according to claim 1, characterized in that, The catalyst includes a platinum catalyst, which comprises any one or more of the following: platinum compounds soluble in polyorganosiloxanes, platinum-olefin complexes, platinum-cyclopropane complexes, alcoholic solutions of hexachloroplatinic acid, platinum catalysts coordinated with tetrahydrofuran, and platinum-vinylsiloxane complexes.

7. The radiation-resistant sterilizable silicone gel dressing according to claim 1, characterized in that, The absorbent layer is a single-layer or multi-layer composite material structure, including any one or more of polyurethane foam, activated carbon fiber, graphene antibacterial fiber, polypropylene fiber, chitosan fiber, and calcium alginate fiber.

8. A method for preparing any one of the radiation-resistant sterilization silicone gel dressings according to claims 1-7, characterized in that, Includes the following steps: Step A: Preparation of radiation-resistant silicone gel compound: Component A is prepared by mixing methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, and catalyst in a certain proportion and stirring until homogeneous; Component B is prepared by mixing methylphenyl vinyl silicone oil, terminal vinyl silicone oil, MDTQ methylphenyl vinyl silicone resin, crosslinking agent, chain extender, and inhibitor in a certain proportion and stirring until homogeneous. Step B: Processing of the porous silica gel layer: Mix component A and component B prepared in step A at a mass ratio of 1-3:1-4, stir thoroughly until homogeneous, and then coat using a coating machine to obtain the porous silica gel layer; processing temperature 50℃-200℃, coating amount 100-1000g / m². 2 ; Rewinding: Set the punching machine parameters, punch and rewind to obtain a perforated radiation-resistant silicone gel; Step C: Preparation of radiation-resistant sterilizable silicone gel dressing: The release layer, the porous silicone gel layer, the absorbent layer, and the water-blocking layer prepared in step B are bonded together by adhesive and heat sealing processes, then die-cut and sterilized by irradiation to obtain the final product.

9. The preparation method according to claim 8, characterized in that, The MDTQ methylphenyl vinyl silicone resin in step A is a silicone resin dispersion, which is formed by dispersing the MDTQ methylphenyl vinyl silicone resin into methylphenyl vinyl silicone oil and / or terminal vinyl silicone oil.

10. The preparation method according to claim 8, characterized in that, In step C, irradiation sterilization is performed using electron beam sterilization, with an irradiation dose of 8kGy-25kGy.

11. The preparation method according to any one of claims 8-10, characterized in that, In step A, the molar ratio of hydroxyl groups to vinyl groups in the system is controlled to be between 0.35 and 0.

85. Component A includes the following components, by weight: 10-40 parts of methylphenyl vinyl silicone oil, 30-75 parts of terminal vinyl silicone oil, 1-10 parts of MDTQ methylphenyl vinyl silicone resin, and 0.01-1 parts of catalyst. Component B includes the following components, by weight: 5-15 parts of methylphenyl vinyl silicone oil, 20-90 parts of terminal vinyl silicone oil, 1-10 parts of MDTQ methylphenyl vinyl silicone resin, 10-20 parts of crosslinking agent, 1-10 parts of chain extender, and 0.01-1 parts of inhibitor.

12. The application of any of the radiation-resistant sterilizable silicone gel dressings according to claims 1-7 in the preparation of materials for wound self-healing, scar inhibition, pressure reduction, antibacterial, deodorizing, and hemostatic purposes.

13. The application of any one of the radiation-resistant sterilizable silicone gel dressings according to claims 1-7 in the preparation of silicone gel foam dressings, eye patches, scar patches, and silicone gel fixation bandages.

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