Medical skin care dressing

Abstract

The invention discloses a medical skin care dressing, and relates to the field of medical dressings, the medical skin care dressing comprises recombinant mussel mucoprotein, Ectoine, beta glucose, a gel matrix, a chelating agent, a pH regulator, a surfactant, a preservative and a solvent, the gel matrix comprises carbomer and cationic guar gum, the chelating agent is EDTA disodium, the pH regulator is triethanolamine, the surfactant is sodium dodecyl sulfate, the preservative is sodium dodecyl sulfate, and the solvent is sodium dodecyl sulfate. The surfactant comprises disodium lauryl sulfosuccinate and cocamidopropyl betaine, the preservative comprises phenoxyethanol and ethyl glycerol, and the solvent is purified water. According to the medical skin care dressing disclosed by the invention, a protective layer is provided on the surface of a wound surface for physical isolation, so that bacteria are prevented from invading and infecting; the mussel mucoprotein is taken as a substrate, a wet microenvironment is provided for a wound surface, wound surface healing is promoted, and the mussel mucoprotein is prepared by a recombinant expression method for expressing target protein in microorganisms through a genetic engineering technology, so that the mussel mucoprotein is suitable for large-scale production, higher in purity, low in toxin and lower in cost.

Description

Technical Field

[0001] This invention relates to the field of medical dressings, and particularly to a medical skin care dressing. Background Technology

[0002] Currently, in clinical applications, the increasing demand for wound healing and restorative functional dressings places higher demands on products. Previous wound dressings were mostly adhesive dressings (using non-woven fabrics, absorbent cotton as a carrier) or gel dressings primarily based on collagen and sodium hyaluronate. The application and development of mussel adhesive protein in wound care was limited. Furthermore, mussel adhesive protein is mainly derived from invertebrates, requiring strict control over animal-derived viruses and resulting in high costs. This study aims to change traditional methods and improve cost control by developing applications for mussel adhesive protein.

[0003] Skin injuries are common in clinical practice. Trauma, burns, inflammatory skin diseases, chronic trauma, surgery, or minimally invasive treatments can all cause skin damage, disrupting the body's physiological barrier. Besides the pathological structural damage caused by the primary injury, secondary damage such as oxidative stress and inflammation can also occur, leading to delayed wound healing and scar formation, causing both physical and psychological distress to patients. Skin repair is a complex, dynamic regulatory process involving a series of orderly interactions between cells, cytokines, and the extracellular matrix in time and space. Its core purpose is to rebuild the skin and restore barrier function. Mussel adhesive protein contains 20% lysine, allowing it to bind to negatively charged human tissue cells through electrostatic adsorption. Combined with a network of microscopic biofilm scaffolds, this provides direction and support for cell adhesion and creep, orderly promoting the growth of normal keratinocytes, fibroblasts, and vascular endothelial cells around the wound from the periphery to the center and from the base upwards. In addition, the positively charged mussel adhesive protein interacts with the negatively charged platelets, promoting platelet aggregation and activation, which in turn promotes blood coagulation. Therefore, mussel adhesive protein shortens the wound healing period by accelerating hemostasis and wound repair.

[0004] Therefore, it is necessary to propose a medical skin care dressing to solve the above problems. Summary of the Invention

[0005] The main objective of this invention is to provide a medical skin care dressing that can effectively solve the problems in the prior art.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: A medical skin care dressing includes recombinant mussel adhesive protein, ectoine, β-glucose, a gel matrix, a chelating agent, a pH adjuster, a surfactant, a preservative, and a solvent. The gel matrix includes carbomer and cationic guar gum. The chelating agent is disodium EDTA. The pH adjuster is triethanolamine. The surfactant includes disodium lauryl sulfosuccinate and cocamidopropyl betaine. The preservative includes phenoxyethanol and ethyl ethyl glycerin. The solvent is purified water. By weight percentage: 0.1%-0.5% recombinant mussel adhesive protein; 0.3%-0.8% ectoine; 0.1%-0.5% β-glucose; 0.5%-1.0% carbomer; 0.05%-0.15% cationic guar gum; 0.1%-0.3% chelating agent; 0.3%-0.5% pH adjuster; 0.1%-0.3% disodium lauryl sulfosuccinate; 0.1%-0.3% cocamidopropyl betaine; 0.4%-0.6% phenoxyethanol; 0.1%-0.3% ethyl ethyl glycerol; balance purified water.

[0007] Preferably, the composition by weight percentage includes: 0.3% recombinant mussel adhesive protein; 0.5% ectoine; 0.3% β-glucose; 0.68% carbomer; 0.1% cationic guar gum; 0.2% chelating agent; 0.36% pH adjuster; 0.2% disodium lauryl sulfosuccinate; 0.2% cocamidopropyl betaine; 0.5% phenoxyethanol; 0.2% ethyl ethyl glycerol; and the balance being purified water.

[0008] Preferably, the preparation steps include the following: S1: Preparation of active ingredient solution: Take 3% of the total water volume of purified water, heat to 60±2℃, add disodium EDTA under uniform stirring at 200-300rpm, and let it dissolve completely. Maintain this temperature and time for ten minutes. After cooling the purified water containing disodium EDTA to below 40°C, it is mixed with purified water that accounts for 95% of the total water volume. Add β-glucan, recombinant mussel adhesive protein, and ectoine in sequence, while controlling the stirring speed to prevent the formation of bubbles; Finally, add triethanolamine, phenoxyethanol, and ethylhexylglycerin, and stir until well combined. S2: Gel matrix construction: Under uniform stirring, the premixed dry powder of carbomer and cationic guar gum is sieved into the active ingredient solution. After the addition is complete, stirring is continued until the powder is completely dispersed. At this time, the system is a milky white thin paste. S3: Final system compounding and gelation. Take 2% of the total water volume of purified water, heat to 50±2℃, add disodium lauryl sulfosuccinate and cocamidopropyl betaine, and stir until a transparent solution is formed. At this point, the preparation of medical skin care dressing is completed. S4: Filling and sterilization, the product is filled in a Class 100,000 clean environment; Sterilization is performed using electron beam irradiation, with the irradiation dose controlled at 15-25 kGy; S5: Testing of the biocompatibility of the dressing. The prepared dressing shall be tested by a third-party testing institution in accordance with GB / T16886.5-2017, GB / T16886.10-2024, and GB / T16886.23-2023. The dressing shall show no potential cytotoxicity, no sensitization reaction, and very slight irritation reaction.

[0009] Preferably, when adding β-glucan, recombinant mussel adhesive protein, and ectoine, each component must be completely dissolved, meaning that the solution must be clear and transparent before adding the next component.

[0010] Compared with the prior art, the present invention provides a medical skin care dressing with the following beneficial effects: This medical skin care dressing, through recombinant mussel adhesive protein, solves the problems of viral safety risks and high production costs associated with animal-derived mussel adhesive protein. It is obtained through genetic engineering and expression in microorganisms, achieving a purity of over 95% and extremely low endotoxin content (<10 EU / mg). Its mechanism of action is based on the high proportion of positively charged lysine residues in the molecule, which electrostatically adsorb onto negatively charged wound tissue cells and the extracellular matrix, forming a biomimetic cell adhesion membrane that activates platelets and promotes local hemostasis.

[0011] This medical skin care dressing, with the addition of ectoine, a highly compatible osmotic pressure-compensating solute, stabilizes the structure of cell membranes and biomolecules in the hyperosmolar or inflammatory environment of the wound, reducing oxidative stress damage to cells and creating a stable internal microenvironment for cells. This indirectly but crucially supports the cell migration and proliferation processes promoted by mussel adhesive proteins. The combination of these two components provides dual protection through active guidance and intrinsic safeguards. β-glucan primarily acts on immune cells, gently regulating the local immune response at the wound site and enhancing the phagocytic function of macrophages, thereby effectively clearing necrotic tissue and potential pathogens. Together, they accelerate the transition from the inflammatory phase to the proliferative phase of wound healing.

[0012] This medical skin care dressing differs from traditional gel dressings, which often use carbomer alone, resulting in gels that are brittle and lack elasticity. This invention addresses this by adding carbomer and cationic guar gum. Carbomer is a polyanionic electrolyte, while cationic guar gum carries a positive charge. In water, the two interact through ionic bonds and molecular chains, forming a denser, stronger, and more elastic interpenetrating network hydrogel structure. This gel structure absorbs a large amount of wound exudate while locking in moisture, perfectly maintaining a moist healing environment. Furthermore, its excellent viscoelasticity and compliance allow it to adhere closely to wounds on various parts of the body, preventing it from easily falling off even during joint movement.

[0013] This medical skin care dressing incorporates triethanolamine not only to neutralize the carboxyl groups of carbomer to form a gel, but also to precisely maintain the final product's pH value within a slightly acidic to neutral range of 6.5-7.5. This pH is close to that of healthy skin, reducing irritation to wounds and promoting a balanced wound microbiome. Disodium EDTA, as a chelating agent, integrates any metal ions that may be present in the water, preventing the oxidation and deterioration of their catalytically active components. It also disrupts the cell walls of some bacteria, enhancing its antiseptic effect.

[0014] This medical skin care dressing uses two extremely mild surfactants, disodium lauryl sulfosuccinate and cocamidopropyl betaine, which allow the dressing to gently cleanse the surrounding oil and dirt while covering the wound, avoiding secondary damage to newly formed tissue when changing dressings. The antiseptic system uses a combination of phenoxyethanol and ethylhexylglycerin; the latter significantly enhances the antiseptic effect of the former, achieving broad-spectrum antibacterial activity at low total dosages, further ensuring the product's gentleness and safety. Attached Figure Description

[0015] Figure 1 This is a process flow diagram of the present invention. Detailed Implementation

[0016] To make the technical means, creative features, objectives and effects of this invention easier to understand, the invention will be further described below in conjunction with specific embodiments.

[0017] Example 1: like Figure 1 As shown, a medical skin care dressing includes recombinant mussel adhesive protein, ectoine, β-glucose, a gel matrix, a chelating agent, a pH adjuster, a surfactant, a preservative, and a solvent. The gel matrix includes carbomer and cationic guar gum. The chelating agent is disodium EDTA. The pH adjuster is triethanolamine. The surfactant includes disodium lauryl sulfosuccinate and cocamidopropyl betaine. The preservative includes phenoxyethanol and ethyl ethyl glycerin. The solvent is purified water. By weight percentage: 0.1%-0.5% recombinant mussel adhesive protein; 0.3%-0.8% ectoine; 0.1%-0.5% β-glucose; 0.5%-1.0% carbomer; 0.05%-0.15% cationic guar gum; 0.1%-0.3% chelating agent; 0.3%-0.5% pH adjuster; 0.1%-0.3% disodium lauryl sulfosuccinate; 0.1%-0.3% cocamidopropyl betaine; 0.4%-0.6% phenoxyethanol; 0.1%-0.3% ethyl ethyl glycerol; balance purified water.

[0018] By weight percentage: 0.3% recombinant mussel adhesive protein; 0.5% ectoine; 0.3% β-glucose; 0.68% carbomer; 0.1% cationic guar gum; 0.2% chelating agent; 0.36% pH adjuster; 0.2% disodium lauryl sulfosuccinate; 0.2% cocamidopropyl betaine; 0.5% phenoxyethanol; 0.2% ethyl ethyl glycerol; balance purified water.

[0019] A medical skin care dressing includes the following preparation steps: S1: Preparation of active ingredient solution: Take 3% of the total water volume of purified water, heat to 60±2℃, add disodium EDTA under uniform stirring at 200-300rpm, and let it dissolve completely. Maintain this temperature and time for ten minutes. After cooling the purified water containing disodium EDTA to below 40°C, it is mixed with purified water that accounts for 95% of the total water volume. Add β-glucan, recombinant mussel adhesive protein, and ectoine in sequence. When adding each component, ensure that it is completely dissolved, that is, the solution is clear and transparent before adding the next component. Control the stirring speed to a level that does not produce bubbles. Finally, add triethanolamine, phenoxyethanol, and ethylhexylglycerin, and stir until well combined. S2: Gel matrix construction: Under uniform stirring, the premixed dry powder of carbomer and cationic guar gum is sieved into the active ingredient solution. After the addition is complete, stirring is continued until the powder is completely dispersed. At this time, the system is a milky white thin paste. S3: Final system compounding and gelation. Take 2% of the total water volume of purified water, heat to 50±2℃, add disodium lauryl sulfosuccinate and cocamidopropyl betaine, and stir until a transparent solution is formed. At this point, the preparation of medical skin care dressing is completed. S4: Filling and sterilization, the product is filled in a Class 100,000 clean environment; Sterilization is performed using electron beam irradiation, with the irradiation dose controlled at 15-25 kGy; S5: Testing of the biocompatibility of the dressing. The prepared dressing shall be tested by a third-party testing institution in accordance with GB / T16886.5-2017, GB / T16886.10-2024, and GB / T16886.23-2023. The dressing shall show no potential cytotoxicity, no sensitization reaction, and very slight irritation reaction.

[0020] Example 2: A medical skin care dressing includes recombinant mussel adhesive protein, ectoine, β-glucose, a gel matrix, a chelating agent, a pH adjuster, a surfactant, a preservative, and a solvent. The gel matrix includes carbomer and cationic guar gum. The chelating agent is disodium EDTA. The pH adjuster is triethanolamine. The surfactants include disodium lauryl sulfosuccinate and cocamidopropyl betaine. The preservatives include phenoxyethanol and ethyl ethyl glycerin. The solvent is purified water. By weight percentage: 0.3% recombinant mussel adhesive protein; 0.5% ectoine; 0.3% β-glucose; 0.68% carbomer; 0.1% cationic guar gum; 0.2% chelating agent; 0.36% pH adjuster; 0.2% disodium lauryl sulfosuccinate; 0.2% cocamidopropyl betaine; 0.5% phenoxyethanol; 0.2% ethyl ethyl glycerol; balance purified water.

[0021] A medical skin care dressing includes the following preparation steps: S1: Preparation of active ingredient solution: Take 3% of the total water volume of purified water, heat to 60±2℃, add disodium EDTA under uniform stirring at 200-300rpm, and let it dissolve completely. Maintain this temperature and time for ten minutes, which is the key to ensuring the efficient dissolution of disodium EDTA. After cooling the purified water containing disodium EDTA to below 40°C, mix it with 95% of the total purified water. The active ingredients must be added after cooling to prevent the high temperature from denaturing or degrading the proteins (mussel adhesive protein) and sugars (β-glucan). Add β-glucan, recombinant mussel adhesive protein, and ectoine in sequence. When adding each ingredient, ensure that it is completely dissolved, that is, the solution is clear and transparent before adding the next one. Control the stirring speed to a range that does not produce too many bubbles. Finally, add triethanolamine, phenoxyethanol, and ethylhexylglycerin, and stir until homogeneous. The homogeneous solution formed in this step is the basis for the stable existence of the active ingredients. S2: Gel matrix construction. Under uniform stirring, the speed can be appropriately increased to 400-500 rpm to form a vortex. The premixed dry powder of carbomer and cationic guar gum is sieved into the active ingredient solution very slowly and evenly. Slow addition and high-speed dispersion are the key to avoid the formation of fish eyes, that is, the outer layer is hydrated and the inner layer is still the core of the dry powder micelles. After the addition is completed, continue stirring until the powder is completely dispersed. At this time, the system is a milky white thin paste. S3: Final system compounding and gelation. Take 2% of the total water volume of purified water, heat to 50±2℃, add disodium lauryl sulfosuccinate and cocamidopropyl betaine, and stir until a transparent solution is formed. At this point, the preparation of medical skin care dressing is completed. S4: Filling and sterilization, the product is filled in a Class 100,000 clean environment; Electron beam irradiation sterilization is used, with the irradiation dose controlled at 15-25 kGy. Compared with high temperature and high pressure sterilization, electron beam irradiation is a cold sterilization method that does not destroy heat-sensitive active ingredients such as mussel adhesive protein, ectoine and gel structure, making it the preferred terminal sterilization method. S5: Testing of the biocompatibility of the dressing. The prepared dressing is tested by a third-party testing agency (in this example, the third-party testing agency is Hunan Xinlinghang Testing Technology Co., Ltd.) according to GB / T16886.5-2017, GB / T16886.10-2024, and GB / T16886.23-2023. If the dressing has no potential cytotoxicity, no sensitization reaction, and very slight irritation reaction, it proves that the product has good biocompatibility.

[0022] The raw materials and formula for Example 2 are shown in the table below: This medical skin care dressing provides a protective layer on the wound surface, physically isolating it to prevent bacterial invasion and infection; it also provides a moist microenvironment to promote wound healing.

[0023] The mussel adhesive protein used in this medical skin care dressing is mainly derived from lower invertebrate tissues. However, animal-derived materials have higher control costs and stricter requirements in virus control methods. The product uses a recombinant expression method that expresses the target protein in microorganisms through genetic engineering technology. This method is suitable for large-scale production, has higher purity, lower toxicity, and lower cost. This mussel adhesive protein gel dressing has excellent conformability and adaptability, allowing it to adapt to and adhere closely to the wound surface, sealing the wound and better exerting its healing-promoting effect. In addition, current clinical applications advocate moist healing, and the hydrogel formulation can lock in moisture, providing a moist microenvironment for wound healing and promoting wound healing.

[0024] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely illustrative of the principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of this invention is defined by the appended claims and their equivalents.

Claims

1. A medical skin care dressing, comprising recombinant mussel adhesive protein, ectoine, β-glucan, a gel matrix, a chelating agent, a pH adjuster, a surfactant, a preservative, and a solvent, characterized in that: The gel matrix includes carbomer and cationic guar gum, the chelating agent is disodium EDTA, the pH adjuster is triethanolamine, the surfactant includes disodium lauryl sulfosuccinate and cocamidopropyl betaine, the preservative includes phenoxyethanol and ethyl ethyl glycerol, and the solvent is purified water. By weight percentage: 0.1%-0.5% recombinant mussel adhesive protein; 0.3%-0.8% ectoine; 0.1%-0.5% β-glucose; 0.5%-1.0% carbomer; 0.05%-0.15% cationic guar gum; 0.1%-0.3% chelating agent; 0.3%-0.5% pH adjuster; 0.1%-0.3% disodium lauryl sulfosuccinate; 0.1%-0.3% cocamidopropyl betaine; 0.4%-0.6% phenoxyethanol; 0.1%-0.3% ethyl ethyl glycerol; balance purified water.

2. The medical skin care dressing according to claim 1, characterized in that: By weight percentage: 0.3% recombinant mussel adhesive protein; 0.5% ectoine; 0.3% β-glucose; 0.68% carbomer; 0.1% cationic guar gum; 0.2% chelating agent; 0.36% pH adjuster; 0.2% disodium lauryl sulfosuccinate; 0.2% cocamidopropyl betaine; 0.5% phenoxyethanol; 0.2% ethyl ethyl glycerol; balance purified water.

3. The medical skin care dressing according to claim 1, characterized in that: The preparation steps include the following: S1: Preparation of active ingredient solution: Take 3% of the total water volume of purified water, heat to 60±2℃, add disodium EDTA under uniform stirring at 200-300rpm, and let it dissolve completely. Maintain this temperature and time for ten minutes. After cooling the purified water containing disodium EDTA to below 40°C, it is mixed with purified water that accounts for 95% of the total water volume. Add β-glucan, recombinant mussel adhesive protein, and ectoine in sequence, while controlling the stirring speed to prevent the formation of bubbles; Finally, add triethanolamine, phenoxyethanol, and ethylhexylglycerin, and stir until well combined. S2: Gel matrix construction: Under uniform stirring, the premixed dry powder of carbomer and cationic guar gum is sieved into the active ingredient solution. After the addition is complete, stirring is continued until the powder is completely dispersed. At this time, the system is a milky white thin paste. S3: Final system compounding and gelation. Take 2% of the total water volume of purified water, heat to 50±2℃, add disodium lauryl sulfosuccinate and cocamidopropyl betaine, and stir until a transparent solution is formed. At this point, the preparation of medical skin care dressing is completed. S4: Filling and sterilization, the product is filled in a Class 100,000 clean environment; Sterilization is performed using electron beam irradiation, with the irradiation dose controlled at 15-25 kGy; S5: Testing of the biocompatibility of the dressing. The prepared dressing shall be tested by a third-party testing institution in accordance with GB / T16886.5-2017, GB / T16886.10-2024, and GB / T16886.23-2023. The dressing shall show no potential cytotoxicity, no sensitization reaction, and very slight irritation reaction.

4. A medical skin care dressing according to claim 3, characterized in that: When adding β-glucan, recombinant mussel adhesive protein, and ectoine, each component must be completely dissolved, meaning the solution must be clear and transparent before adding the next component.

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