Food-grade degradable skin adhesion drug sustained-release membrane

Abstract

The invention relates to the technical field of medical application, in particular to a food-grade degradable skin adhesion drug sustained-release membrane which comprises a sealing module, a synergistic module and a drug sustained-release module, and the synergistic module and the drug sustained-release module are located in the sealing module. The sealing module is divided into an upper part and a lower part, and the synergistic module and the drug sustained-release module are arranged in the sealing module in a sheet shape; the drug sustained release module comprises a drug carrier layer, a viscosity adjusting layer, a substrate bonding layer and a release film which are sequentially distributed from top to bottom; due to the integrated design of the medicine carrier layer, the viscosity adjusting layer and the substrate bonding layer, a three-in-one food-grade material composite system of substrate bonding, viscosity adjusting and medicine carrier is created for the first time, and the application bottleneck of edible materials in the field of medical skin adhesion is solved in a breakthrough mode. Skin irritation and allergy risks caused by chemical adhesives are completely eradicated from the source, a dynamic viscosity adjusting mechanism is constructed by means of the intrinsic characteristics of materials of the base adhesive layer, the function of automatic falling over time after application is achieved, and dynamic adaptation of viscosity and the physiological state of the skin is achieved.

Description

TECHNICAL FIELD

[0001] The application relates to the technical field of medical dressings, in particular to a food-grade degradable skin-adhesive drug sustained-release film. BACKGROUND

[0002] The adhesion performance of traditional medical dressings depends on chemical adhesives such as acrylate and rubber, which have strong adhesion but have two major defects: firstly, the chemical adhesives can easily cause skin allergy or irritation, and have poor compatibility with sensitive skin, children and long-term medication groups, and about 20% of the users will have adverse reactions such as skin redness and itching; secondly, when removed, the adhesives are easily left behind and need to be pulled off with force, which can damage the cuticle or cause skin damage, thereby damaging the skin barrier function, and the drug carrier is usually ordinary non-woven fabric or film, which lacks an effective drug release mechanism, so that the drug release rate is difficult to accurately control, and the absorption efficiency is low, therefore, the food-grade degradable skin-adhesive drug sustained-release film is proposed to solve the above problems. SUMMARY

[0003] The application aims to provide a food-grade degradable skin-adhesive drug sustained-release film to solve the problems in the background.

[0004] To achieve the above-mentioned purpose, the application provides the following technical scheme: As an optional solution of the food-grade degradable skin-adhesive drug sustained-release film, the food-grade degradable skin-adhesive drug sustained-release film comprises a sealing module, and a synergistic module and a drug sustained-release module located inside the sealing module. The sealing module is divided into two parts, and the synergistic module and the drug sustained-release module are in sheet form and located in the sealing module. The drug sustained-release module comprises a drug carrier layer, an adhesion adjusting layer, a base adhesive layer and a release film which are sequentially arranged in an up-down manner. The drug carrier layer, the adhesion adjusting layer and the base adhesive layer are integrally arranged, and the release film is covered on the other side of the base adhesive layer. The other side of the drug carrier layer is compounded with the synergistic module, and the synergistic module is used for heating and tightening the drug sustained-release module.

[0005] As an optional solution of the food-grade degradable skin-adhesive drug sustained-release film, the base adhesive layer is made of dopamine-modified xanthan gum and chitosan derivatives, and the base adhesive layer is used to provide basic adhesion.

[0006] As an optional solution of the food-grade degradable skin-adhesive drug sustained-release film, the adhesion adjusting layer is made of konjac glucomannan, glycerol and citric acid, and the adhesion adjusting layer is used to dynamically control the adhesion strength.

[0007] As an optional solution of the food-grade degradable skin-adhesive drug sustained-release film, the drug carrier layer is made of polyhydroxyalkanoate and soy lecithin, which is used to load water-soluble or fat-soluble drugs.

[0008] The adhesion performance of traditional medical dressings depends on chemical adhesives such as acrylates and rubbers. Although they have strong adhesion, they have two major defects: first, chemical adhesives can cause skin allergy or irritation, and are not compatible with sensitive skin, children and long-term medication groups. About 20% of users will have adverse reactions such as skin redness and itching. Second, when removed, the adhesive residue is easily left behind, and forceful tearing can damage the skin keratin layer or cause skin damage, thereby damaging the skin barrier function. In addition, the drug carrier of the medical dressing is usually ordinary non-woven fabric or film, which lacks an effective drug release mechanism, making it difficult to accurately control the drug release rate and reducing the absorption efficiency. The device integrates the drug carrier layer, the adhesion adjustment layer and the base adhesion layer, and creates a "base adhesion-adhesion adjustment-drug carrier" three-in-one food-grade material composite system, which breaks through the application bottleneck of edible materials in the field of medical skin adhesion, eliminates the risk of skin irritation and allergy caused by chemical adhesives from the source, and relies on the intrinsic properties of the base adhesion layer to build a dynamic adhesion adjustment mechanism, which can automatically fall off over time after application, dynamically adapts to the adhesion and physiological state of the skin, and the glycerol in the adhesion adjustment layer can continuously moisturize the skin during use, stably delivering water to the skin keratin layer to expand the gap between keratinocytes and create a favorable channel for drug molecules to penetrate. At the same time, the polyhydroxyalkanoate in the drug carrier layer forms a nano-porous structure, and the drug molecules are uniformly wrapped therein. As the carrier material and the skin interact and gradually degrade, the drug is released at a stable rate, avoiding fluctuations in local drug concentration caused by rapid drug loss, and effectively isolating the drug from the skin, significantly reducing the risk of irritation.

[0009] As an optional solution of the food-grade degradable skin-adhesive drug sustained-release film, the drug carrier layer is made of polyhydroxyalkanoate and soy lecithin, which is used to load water-soluble or fat-soluble drugs.

[0010] As an optional solution of the food-grade degradable skin-adhesive drug sustained-release film, the drug carrier layer is made of polyhydroxyalkanoate and soy lecithin, which is used to load water-soluble or fat-soluble drugs.

[0011] The coordinated design of the upper and lower unit sealing layers provides dual protection for the drug sustained-release module and the enhancement module, effectively preventing the volatilization and loss of the drug's active ingredients. For sealing reliability, the device adds a leak detection ball as a sealing detection element: in a dry state, the cobalt chloride inside the leak detection ball is blue; when a leak occurs and moisture is absorbed, the cobalt chloride undergoes a hydration reaction to form cobalt chloride hexahydrate, and the color turns pink simultaneously, enabling visual detection of sealing failure.

[0012] As an alternative embodiment of the food-grade biodegradable skin-adhesive drug sustained-release film of the present invention, the synergistic module includes a coating layer and a synergistic element distributed vertically, the coating layer is attached to the upper surface of the synergistic element, and the other side of the synergistic element is connected to the drug sustained-release module.

[0013] As an alternative to the food-grade biodegradable skin-adhesive drug sustained-release film of the present invention, the synergist includes a heating layer connected to the drug carrier layer at its bottom, a staggered heating rod embedded above the heating layer, a sealing film covering the heating rod, and one side of the sealing film being integrally formed with the protruding film.

[0014] As an alternative embodiment of the food-grade biodegradable skin-adhesive drug sustained-release film of the present invention, a moisture-absorbing block is installed on both sides above the heating layer, the upper surface of the moisture-absorbing block is covered with a sealing sheet, a strip plate connected to the heating layer is provided on one side of the moisture-absorbing block, and deformation strips embedded above the heating layer are connected to both ends of the other side of the strip plate.

[0015] As an alternative to the food-grade biodegradable skin-adhesive drug sustained-release film described in this invention, the heating layer has uniformly distributed pores on its surface.

[0016] In terms of the enhancement module design, when using it, the sealing film and protruding film on one side can be peeled off first to expose the heating rod and allow it to come into contact with the air to generate an exothermic reaction. If the patient feels that the temperature is insufficient, the sealing film and protruding film on both sides can be peeled off simultaneously to ensure stable heating effect. This heating structure can also be used alone on one side. When the deformation strip on one side fails, the other side can be activated immediately to achieve long-term stable heating. This heating method acts directly on the patient area, expanding the gap between pores by raising the temperature, further improving the drug penetration efficiency. It is easy to operate and suitable for clinical use scenarios. In addition, the moisture-absorbing blocks on both sides of the heating layer utilize the property of volume expansion after absorbing moisture to drive the strip plate and deformation strip to work together, causing the heating layer to move appropriately to both sides, thereby causing the drug release module below to pull the skin that is adhered to to both sides and extend it to both sides, achieving a skin tightening effect—ensuring the uniformity and effectiveness of drug release, and also providing assistance for the subsequent automatic detachment of the device.

[0017] Compared with the prior art, the beneficial effects of the present invention are: This device, through its integrated design of a drug carrier layer, an adhesive modifier layer, and a base adhesive layer, pioneers a three-in-one food-grade material composite system of "base adhesive-adhesive modifier-drug carrier," breaking through the bottleneck of edible materials in the field of medical skin adhesion. It eliminates the risk of skin irritation and allergies caused by chemical adhesives from the source. Relying on the intrinsic material properties of the base adhesive layer, it constructs a dynamic adhesive modifier mechanism, which can achieve the function of automatic detachment over time after application, achieving dynamic adaptation of adhesiveness to the physiological state of the skin.

[0018] During use, the glycerin component in the viscosity-regulating layer provides continuous moisturizing, stably delivering moisture to the stratum corneum to expand the intercellular spaces and create favorable channels for drug molecule penetration. Simultaneously, the polyhydroxyalkanoates in the drug carrier layer form a nanoscale porous structure, uniformly encapsulating drug molecules. As the carrier material gradually degrades through interaction with the skin, the drug is released slowly at a stable rate, avoiding local concentration fluctuations caused by rapid drug loss and effectively isolating the drug from direct contact with the skin, significantly reducing the risk of irritation.

[0019] Regarding the design of the enhancement module, when using it, the sealing film and protruding film on one side can be peeled off first to expose the heating rod and allow it to come into contact with the air to generate an exothermic reaction. If the patient feels insufficient temperature, the sealing film and protruding film on both sides can be peeled off simultaneously to ensure stable heating effect. This heating structure can also be used alone on one side. When the deformation strip on one side fails, the other side can be activated immediately to achieve long-term stable heating. This heating method acts directly on the patient area, expanding the gap between pores by increasing temperature, further improving drug penetration efficiency. It is easy to operate and suitable for clinical use scenarios.

[0020] In addition, the moisture-absorbing blocks on both sides of the heating layer utilize the property of volume expansion after absorbing moisture to drive the strip plate and deformation strip to work together, causing the heating layer to move appropriately to both sides, thereby causing the drug release module below to pull the skin that is adhered to to both sides and extend it to both sides, achieving a skin tightening effect—ensuring the uniformity and effectiveness of drug release, and also providing assistance for the subsequent automatic detachment of the device.

[0021] The coordinated design of the upper and lower unit sealing layers provides dual protection for the drug sustained-release module and the enhancement module, effectively preventing the volatilization and loss of the drug's active ingredients. For sealing reliability, the device adds a leak detection ball as a sealing detection element: in a dry state, the cobalt chloride inside the leak detection ball is blue; when a leak occurs and moisture is absorbed, the cobalt chloride undergoes a hydration reaction to form cobalt chloride hexahydrate, and the color turns pink simultaneously, enabling visual detection of sealing failure. Attached Figure Description

[0022] Figure 1A schematic diagram of the overall structure of a food-grade biodegradable skin-adhesive drug-releasing membrane; Figure 2 This is a schematic diagram of the structure of a food-grade biodegradable skin-adhesive drug sustained-release film synergist.

[0023] In the diagram: 1. Upper unit sealing layer; 2. Coating layer; 3. Enhancement component; 301. Heating layer; 302. Heating rod; 303. Moisture-absorbing block; 304. Strip plate; 305. Deformation strip; 306. Sealing membrane; 307. Protruding membrane; 308. Sealing sheet; 5. Drug carrier layer; 6. Viscosity adjustment layer; 7. Substrate adhesive layer; 8. Release membrane; 9. Lower unit sealing layer; 10. Detection groove; 11. Leak test ball. Detailed Implementation

[0024] Example 1: Please refer to Figure 1 The present invention provides a technical solution: A food-grade, biodegradable, skin-adhesive drug-releasing film. It includes a sealing module and an enhancement module and a drug sustained-release module located inside the sealing module; The sealing module is divided into upper and lower parts, with the enhancement module and drug sustained-release module located in the middle in sheet form; The drug sustained-release module includes a drug carrier layer 5, a viscosity adjustment layer 6, a base adhesive layer 7, and a release membrane 8 arranged in a vertical sequence. The drug carrier layer 5, the viscosity adjustment layer 6, and the substrate adhesive layer 7 are integrally formed, and the release film 8 covers the other side of the substrate adhesive layer 7. The other side of the drug carrier layer 5 is composited with an enhancement module, which is used to heat and tighten the drug sustained-release module.

[0025] The base adhesive layer 7 is made of dopamine-modified xanthan gum and chitosan derivatives. The base adhesive layer 7 is used to provide basic adhesion, drawing on the adhesion mechanism of natural polysaccharides to replace acrylic chemical adhesives.

[0026] The viscosity modulating layer 6 is made of konjac glucomannan, glycerol and citric acid. The viscosity modulating layer 6 is used to dynamically control the viscosity strength.

[0027] The drug carrier layer 5 is made of polyhydroxyalkanoate and soybean lecithin, which is used to load water- or lipid-soluble drugs to achieve sustained and controlled release.

[0028] Traditional medical dressings rely on chemical adhesives such as acrylates and rubbers for adhesion. While these adhesives offer strong adhesion, they suffer from two major drawbacks: First, chemical adhesives easily trigger skin allergies or irritation, resulting in poor compatibility with sensitive skin, children, and long-term users. Approximately 20% of users experience adverse reactions such as skin redness, swelling, and itching. Second, removal often leaves adhesive residue and requires forceful tearing, potentially damaging the stratum corneum or causing skin abrasions, thereby disrupting the skin barrier function. Furthermore, their drug carriers are mostly ordinary non-woven fabrics or films, lacking effective controlled-release mechanisms, leading to insufficient drug delivery. The release rate is difficult to control precisely, and the absorption efficiency is low. This device, through the integrated design of drug carrier layer 5, viscosity adjustment layer 6 and base adhesive layer 7, pioneered a three-in-one food-grade material composite system of "base adhesive-viscosity adjustment-drug carrier". It breaks through the application bottleneck of edible materials in the field of medical skin adhesion, eliminates the risk of skin irritation and allergies caused by chemical adhesives from the source, and builds a dynamic viscosity adjustment mechanism based on the material intrinsic properties of base adhesive layer 7. It can realize the function of automatic detachment over time after application, and achieve dynamic adaptation of viscosity and skin physiological state. The specific stages are as follows: Initial adhesion stage (0-10 seconds): Glycerin (food-grade moisturizer) in viscosity conditioning layer 6 quickly penetrates the stratum corneum of the skin, causing the molecular chains of konjac glucomannan to unfold. Dopamine modifies the phenolic hydroxyl groups of xanthan gum to form transient hydrogen bonds with the amino groups on the skin surface. Stable adhesion strength (shear strength ≥15kPa) can be achieved by pressing for 10 seconds, solving the problem of "not sticking well". During continuous use (10 seconds to 4 hours): the membrane material slowly integrates with the sweat and sebum secreted by the skin. The viscosity adjustment layer 6 maintains the adhesion strength at 8-12 kPa through a dynamic balance of "water absorption and swelling - moderate cross-linking". This not only resists mechanical forces such as joint flexion and extension and limb movement, but also avoids skin pressure caused by excessive adhesion. Peeling stage (4-8 hours): As the moisture in the membrane evaporates, the polysaccharide molecular chains gradually shrink, the viscosity adjustment layer 6 loses its swelling properties, and the adhesion strength drops to below 3 kPa, achieving "natural peeling without residue" and completely solving the pain points of traditional adhesive tapes that are "unbreakable and easy to leave adhesive residue". Breaking away from the traditional "single carrier drug release" model, this system constructs a dual-effect synergistic system of "membrane softening of the stratum corneum + carrier sustained-release of the drug," achieving efficient and gentle drug penetration. In the keratinization process: Food-grade moisturizing ingredients such as glycerin in the viscosity regulation layer 6 can continuously deliver moisture to the stratum corneum of the skin, which expands the intercellular spaces of the keratinocytes and widens the pore size of the permeation channels from the traditional 2-5nm to 8-12nm, creating favorable conditions for drug molecule penetration, while avoiding the irritation of the skin by chemical penetration enhancers (such as azone). Drug sustained-release process: The polyhydroxyalkanoate of drug carrier layer 5 forms a nanoscale porous structure, encapsulating the loaded drug molecules. Through the interaction between the gel membrane and the skin, the carrier material slowly degrades, releasing the drug at a rate of 0.5-2 μg / (cm³). 2 The stable release rate of .h) avoids concentration fluctuations caused by rapid drug loss and prevents irritation caused by direct skin contact with the drug, significantly reducing the risk of irritation. By creating an integrated product lifecycle encompassing "use-degradation-detachment," this approach addresses the pain points of traditional medical adhesive products from both user experience and environmental perspectives. Natural shedding during later use: After 4-8 hours of drug delivery, as moisture evaporates, the film gradually dries and thins (thickness decreases from the initial 50-80μm to 10-15μm), and the structural strength weakens. It can be peeled off by gently tearing it off, or it will naturally detach with the normal skin metabolism (such as exfoliation) without the need for forceful tearing. Environmentally friendly degradation: The core components of the material (chitosan, PHA, konjac glucomannan) can be decomposed into water, carbon dioxide and natural polysaccharides by microorganisms in the natural environment, with a natural degradation rate of ≥95% in 15 days; even if discarded by humans, it can be completely dissolved in water within 30 minutes without any solid residue, avoiding the pressure of medical waste disposal. The food-grade ingredients achieve "zero skin irritation" and are suitable for special areas such as wounds and sensitive skin, solving the industry problem of a high allergy rate of 12%-18% for traditional patches; In terms of performance: The dynamic adhesion adjustment mechanism enables a full-cycle experience of "adhesive upon application, stable adhesion during use, and painless removal", while the "gel film-drug controlled release" synergistic system improves drug delivery efficiency and balances adhesion reliability, efficacy and skin friendliness; From an environmental perspective: the "degradable + shedding with metabolism" solution reduces the cost of medical waste disposal, adapts to diverse usage scenarios, and balances environmental friendliness and practicality.

[0029] Example 2: This example is an improvement upon Example 1. Please refer to [link / reference]. Figure 1 Specifically, the sealing module includes an upper unit sealing layer 1 and a lower unit sealing layer 9. The opposite end faces of the upper unit sealing layer 1 and the lower unit sealing layer 9 are recessed to accommodate the enhancement module and the drug sustained-release module. Furthermore, a recessed detection groove 10 is provided on one side of the recessed surface of the upper unit sealing layer 1 and the lower unit sealing layer 9, and a leak detection ball 11 is provided inside the detection groove 10.

[0030] The leak test ball 11 is made of color-changing silicone that changes color after absorbing moisture.

[0031] The coordinated design of the upper unit sealing layer 1 and the lower unit sealing layer 9 provides dual protection for the drug sustained-release module and the enhancement module, effectively preventing the volatilization and loss of the drug's active ingredients. For the design of sealing reliability, the device adds a leak detection ball 11 as a sealing detection element: the main components of the color-changing silica gel are porous silica and cobalt chloride. In a dry state, the cobalt chloride inside the leak detection ball 11 is blue. When a poor seal occurs and moisture is absorbed, humid air enters the detection tank 10, comes into contact with its leak detection ball 11 and reacts. The cobalt chloride undergoes a hydration reaction to generate cobalt chloride hexahydrate, and the color changes to pink simultaneously, realizing the visual detection of sealing failure.

[0032] Example 3: This example is an improvement on Example 2. Please refer to [link / reference]. Figure 2 Specifically, the enhancement module includes a coating layer 2 and an enhancement component 3 distributed vertically. The coating layer 2 is attached to the upper surface of the enhancement component 3, and the other side of the enhancement component 3 is connected to the drug sustained-release module.

[0033] The synergist 3 includes a heating layer 301 connected to the drug carrier layer 5 at its bottom. A staggered heating rod 302 is embedded above the heating layer 301. A sealing film 306 covers the heating rod 302. One side of the sealing film 306 is integrally formed with the protruding film 307.

[0034] Moisture-absorbing blocks 303 are installed on both sides above the heating layer 301. A sealing sheet 308 covers the upper surface of the moisture-absorbing blocks 303. A strip plate 304 connected to the heating layer 301 is provided on one side of the moisture-absorbing blocks 303. Deformation strips 305 embedded above the heating layer 301 are connected to both ends of the other side of the strip plate 304.

[0035] The surface of the heating layer 301 has evenly distributed vent holes.

[0036] In terms of the enhancement module design, when using it, the sealing film 306 and the protruding film 307 on one side can be peeled off first, so that the heating rod 302 can be exposed and come into contact with the air to generate an exothermic reaction. If the patient feels that the temperature is insufficient, the sealing film 306 and the protruding film 307 on both sides can be peeled off at the same time to ensure stable heating effect. This heating structure can also be used alone on one side. When the deformation strip 305 on one side fails, the other side can be activated immediately to achieve long-term stable heating. This heating method acts directly on the patient area, and expands the gap between pores by heating up, further improving the drug penetration efficiency. It is easy to operate and suitable for clinical use scenarios. The heating rod 302 is made of methanol gel, catalyst powder and slow-release agent mixed and pressed. After contact with air, it is slowly oxidized by the catalyst and continuously releases heat. There is no open flame or liquid leakage in the whole process. It can be discarded after use. The products are carbon dioxide and water. Methanol gel: As a core fuel base material, methanol itself is a highly efficient and low-carbon fuel that can stably produce carbon dioxide and water after combustion. Making it into a gel form is a key improvement. For example, calcium acetate is commonly used as a gelling agent, which can make methanol form a high-viscosity, low-volatility solid structure. This can not only avoid liquid methanol leakage, but also reduce the safety hazards caused by volatilization, while retaining its high heat efficiency. Its calorific value can usually reach 15-20 MJ / L, which can meet the energy demand for continuous exothermic heat. Catalyst powder: Its core function is to lower the reaction threshold of methanol oxidation and achieve low-temperature, flameless oxidation. Common high-efficiency catalysts, such as Pt / Al2O3 fiber composite catalysts, can trigger the reaction of methanol and oxygen at room temperature. Slow-release agents: used to precisely control the reaction rate. They can prevent the rapid oxidation of methanol and the sudden temperature rise by physically blocking or adjusting the contact area between methanol gel and air. For example, some polymer slow-release materials can allow methanol vapor to slowly permeate to the catalyst surface, thereby achieving continuous heat release. This can ensure that the heating process is stable within a comfortable or applicable temperature range of 40-60℃, avoiding local overheating. In addition, the moisture-absorbing blocks 303 arranged on both sides of the heating layer 301 utilize the characteristic of volume expansion after absorbing moisture. The water produced by the oxidation reaction of the heating rod 302 evaporates in the form of trace water vapor. The moisture-absorbing blocks 303 absorb moisture and expand, which can drive the strip plate 304 and the deformation strip 305 to work together, causing the heating layer 301 to move appropriately to both sides. This, in turn, causes the drug release module below to pull the skin that is adhered to to both sides and extend it to both sides, achieving a skin tightening effect. This not only ensures the uniformity and effectiveness of drug release, but also provides assistance for the subsequent automatic detachment of the device. The ventilation holes ensure the device's breathability, preventing poor membrane breathability from causing skin stuffiness, sweat buildup, and affecting the user experience; The deformation strip 305 is made of a slightly curved, deformable material, which ensures that when the moisture-absorbing block 303 absorbs water and expands, it pushes the strip plate 304 toward the deformation strip 305. The deformation strip 305 and the strip plate 304 push the moisture-absorbing block 303 in the opposite direction, which is used to stretch the skin bonded to the drug sustained-release module to both sides, so as to achieve the purpose of tightening the skin in the disease area.

[0037] This article uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only for the purpose of helping to understand the method and core ideas of the present invention. The above descriptions are only preferred embodiments of the present invention. It should be noted that due to the limitations of textual expression, while there are objectively infinite specific structures, those skilled in the art can make several improvements, modifications, or changes without departing from the principles of the present invention, and can also combine the above technical features in an appropriate manner. These improvements, modifications, changes, or combinations, or the direct application of the inventive concept and technical solution to other situations without modification, should all be considered within the scope of protection of the present invention.

Claims

1. A food-grade biodegradable skin-adhesive drug-releasing film, characterized in that: It includes a sealing module and an enhancement module and a drug sustained-release module located inside the sealing module; The sealing module is divided into upper and lower parts, with the enhancement module and drug sustained-release module located in a sheet-like form within it; The drug sustained-release module includes a drug carrier layer (5), a viscosity adjustment layer (6), a base adhesive layer (7), and a release membrane (8) arranged in a vertical sequence. The drug carrier layer (5), the viscosity adjustment layer (6) and the substrate adhesive layer (7) are integrally formed, and the release film (8) covers the other side of the substrate adhesive layer (7); The other side of the drug carrier layer (5) is composite with an enhancement module, which is used to heat and tighten the drug sustained-release module.

2. The food-grade biodegradable skin-adhesive drug-releasing film according to claim 1, characterized in that: The base adhesive layer (7) is made of dopamine-modified xanthan gum and chitosan derivatives, and the base adhesive layer (7) is used to provide basic adhesion.

3. The food-grade biodegradable skin-adhesive drug-releasing film according to claim 1, characterized in that: The viscosity modulating layer (6) is made of konjac glucomannan, glycerol and citric acid. The viscosity modulating layer (6) is used to dynamically regulate the viscosity strength.

4. The food-grade biodegradable skin-adhesive drug-releasing film according to claim 1, characterized in that: The drug carrier layer (5) is made of polyhydroxy fatty acid ester and soybean lecithin, which is used to load water- or fat-soluble drugs.

5. The food-grade biodegradable skin-adhesive drug-releasing film according to claim 1, characterized in that: The sealing module includes an upper unit sealing layer (1) and a lower unit sealing layer (9). The opposite end faces of the upper unit sealing layer (1) and the lower unit sealing layer (9) are recessed to accommodate the enhancement module and the drug sustained release module. A recessed detection groove (10) is also provided on one side of the recessed surface of the upper unit sealing layer (1) and the lower unit sealing layer (9), and a leak detection ball (11) is provided inside the detection groove (10).

6. The food-grade biodegradable skin-adhesive drug-releasing film according to claim 5, characterized in that: The leak test ball (11) is made of color-changing silica gel that changes color after absorbing moisture.

7. The food-grade biodegradable skin-adhesive drug-releasing film according to claim 1, characterized in that: The enhancement module includes a coating layer (2) and an enhancement component (3) distributed vertically. The coating layer (2) is attached to the upper surface of the enhancement component (3), and the other side of the enhancement component (3) is connected to the drug sustained-release module.

8. The food-grade biodegradable skin-adhesive drug-releasing film according to claim 7, characterized in that: The enhancement component (3) includes a heating layer (301) connected to the drug carrier layer (5) at the bottom. A staggered heating rod (302) is embedded above the heating layer (301). A sealing film (306) is covered above the heating rod (302). One side of the sealing film (306) is integrally formed with the protruding film (307).

9. The food-grade biodegradable skin-adhesive drug-releasing film according to claim 8, characterized in that: Moisture-absorbing blocks (303) are installed on both sides above the heating layer (301). The upper surface of the moisture-absorbing block (303) is covered with a sealing sheet (308). A strip plate (304) connected to the heating layer (301) is provided on one side of the moisture-absorbing block (303). Deformation strips (305) embedded above the heating layer (301) are also connected to both ends of the other side of the strip plate (304).

10. The food-grade biodegradable skin-adhesive drug-releasing film according to claim 8, characterized in that: The surface of the heating layer (301) has uniformly distributed vent holes.

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