Gel patch with high moisturizing and repairing functions and preparation method of gel patch

Abstract

According to the technical scheme, the high-moisture-retention repairing gel application is characterized in that a surface film layer serves as an outermost protective barrier of the application, so that local humidity regulation and control can be guaranteed through high moisture permeability and permeation resistance of the surface film layer; the invasion of external microorganisms, pollutants, dust particles and the like on wound surfaces or sensitive skin is effectively prevented, and sealing support is provided for the internal gel layer; the gel layer is arranged between the membrane layer and the supporting layer, bears various bioactive components, forms a wet-imitating environment, is in direct contact with the skin during use, quickly releases moisturizing and repairing factors and adjusts the pH and moisture of a microenvironment, and can be attached to the surface of the skin to form a tight and soft contact interface due to the good touch feeling and rheological characteristics of the gel layer; and the substrate supporting layer is used as a bottom carrier to provide structural supporting tension buffering and overall strength enhancing effects on the gel layer, and meanwhile, the application stability is improved, so that a user can conveniently wear the gel on multiple parts and the dynamic skin surface for a long time without easily falling off and being damaged.

Description

Technical Field

[0001] The present invention relates to the technical field of hydrogel dressings, and particularly relates to a highly moisturizing and repairing hydrogel dressing and a preparation method thereof. Background Art

[0002] A hydrogel dressing is a medical dressing designed based on hydrogel materials. By combining the physical properties of polymer materials with biomedical functions, it demonstrates unique value in the fields of wound repair, drug delivery, and tissue engineering. Its core consists of a three-dimensional cross-linked hydrophilic polymer network (such as polyacrylic acid, chitosan, gelatin, etc.). By integrating the latest achievements in materials science, molecular biology, and clinical medicine, it has achieved a paradigm upgrade from a physical barrier to bioactive regulation in wound care. It can absorb up to 90% of its own weight of exudate, while maintaining a moist microenvironment, and has dual functions of physical barrier and bioactive regulation;

[0003] For example, in the Chinese patent with the publication number CN211300630U, a gel hot compress patch is proposed. The component includes an ointment gel layer and a heating layer. The heating layer is pasted on the back of the ointment gel layer. The ointment gel layer is quadrilateral in shape. The ointment gel layer includes essential oil, medicinal powder, and a covering cloth. The heating layer is made of a heating material, and the area of the heating layer is smaller than that of the ointment gel layer. The heating layer is a heating pack, and the heating pack is pasted in the middle of the back of the ointment gel layer. A release layer is provided on the side of the ointment gel layer that fits the skin. After the essential oil and the medicinal powder are mixed evenly, they are applied on the covering cloth, and then the ointment gel layer is made by gel wrapping. The proposed gel hot compress patch integrates essential oil, medicinal powder, and the covering cloth, cancels the setting of the back glue, and the whole product has only two components, with a simple structure. The heating layer does not directly contact the skin, thereby improving safety and reducing costs. When using, only the side of the ointment gel layer needs to be pasted on the uncomfortable part of the human body;

[0004] However, in actual use of the above device, the hydrogel dressing will affect its therapeutic effect due to problems such as too fast water evaporation and limited repair effect during use. To solve the above problems, we propose a highly moisturizing and repairing hydrogel dressing and a preparation method thereof. Summary of the Invention

[0005] Aiming at the deficiencies of the prior art, the present invention provides a highly moisturizing and repairing hydrogel dressing and a preparation method thereof, which solves the problem that the hydrogel dressing will affect its therapeutic effect due to problems such as too fast water evaporation and limited repair effect during use.

[0006] The above technical objectives of the present invention are achieved through the following technical solutions:

[0007] A gel patch for high moisturizing and repair, which successively includes a surface film layer, a gel layer, and a base support layer from top to bottom. The surface film layer is a polyurethane film, and the base support layer is a non-woven fabric. It is characterized in that the gel layer is made of the following raw materials and their weight percentages: sodium hyaluronate 0.3g, accounting for 0.1% - 0.5% of the total weight of the preparation; glycerol 10g, accounting for 5% - 15% of the total weight of the preparation; carbomer 0.2g, accounting for 1% - 5% of the total weight of the preparation; propylene glycol 3g, accounting for 2% - 8% of the total weight of the preparation; and the balance is purified water. A pH regulator and a preservative are additionally added to the formula.

[0008] Preferably, the preparation method of the polyurethane film is as follows:

[0009] Dissolve the polyurethane resin in the solvent ethyl acetate, and a plasticizer and a surfactant can be added;

[0010] Uniformly coat the solution on the PET base film;

[0011] Heat and dry at 60 - 80°C to volatilize the solvent and form a uniform transparent film, thus obtaining it.

[0012] Preferably, the preservative is a freshly prepared mixed liquid, which is prepared by compounding methylparaben, ethylparaben, propylene glycol and the balance of water, and needs to be pre-dissolved in advance.

[0013] Preferably, the pH regulator is triethanolamine, which is of pharmaceutical grade and is used to buffer and adjust the pH value of the gel layer to between 4.5 and 7.5 to ensure the stability of the formula and the skin adaptability.

[0014] Preferably, the purified water is prepared by a combined process of physical filtration + reverse osmosis + disinfection and sterilization. The reverse osmosis membrane is used to remove about 99% of ions and organic substances, and the remaining ions and microorganisms can be removed after microfiltration.

[0015] A preparation method of a gel patch for high moisturizing and repair, which is characterized in that the preparation method includes the following steps:

[0016] S1: Dissolve carbomer in purified water at 80°C, stir and dissolve to form a uniform solution;

[0017] S2: When the temperature drops to 40°C - 50°C, successively add glycerol, sodium hyaluronate, and the preservative, and stir evenly at low speed;

[0018] S3: Add the pH regulator to the mixed solution and adjust the pH value to 5.5 - 6.5;

[0019] S4: After the temperature drops to room temperature, uniformly coat the mixed solution on the support layer, then cover the surface film layer on the surface of the solution layer, and dry at low temperature for 24 hours to form a film;

[0020] S5: Cut and shape, and then perform aseptic packaging to obtain the product.

[0021] In summary, the present invention mainly has the following beneficial effects:

[0022] Since the surface film layer serves as the outermost protective barrier of the dressing, its high moisture permeability and anti-permeability can effectively prevent the invasion of external microorganisms, pollutants, dust particles, etc. to the wound surface or sensitive skin while ensuring local humidity regulation, providing a closed support for the internal gel layer; the gel layer is placed between the film layer and the support layer, carrying a variety of bioactive components, forming a moisture-mimicking environment, directly contacting the skin during use, quickly releasing moisturizing and repair factors and regulating the microenvironment pH and moisture. Its good touch and rheological properties enable it to fit the skin surface to form a tight and soft contact interface; the base support layer serves as the bottom carrier, providing structural support, tension buffering and overall strength enhancement for the gel layer, while improving the sticking stability, facilitating the user to wear it for a long time on multi-site and dynamic skin surfaces without easy falling off or damage.

[0023] Since the surface film layer is made of medical-grade polyurethane film material, it has good biocompatibility, flexibility and water vapor transmission rate (MVTR). While blocking external bacterial and particulate contamination, it allows the moisture generated by tissue metabolism to permeate, thus constructing a closed and moisture-permeable "moist wound healing environment", which is beneficial to epidermal cell migration and wound self-repair. At the same time, the base support layer has good mechanical strength and flexibility, which can provide stable structural support for the gel layer, preventing the gel from failing due to deformation, shear force or hydration swelling. At the same time, the base support layer has good mechanical strength and flexibility, which can provide stable structural support for the gel layer, preventing the gel from failing due to deformation, shear force or hydration swelling; it can be selected as breathable or airtight according to needs. Under specific designs, the base support layer can be given multiple functions such as antibacterial, liquid absorption, anti-seepage or skin-friendly through coating treatment. At the same time, the polyurethane film has a certain degree of ductility and resilience, and can adapt to the small deformations of the skin in different parts after application, improving the conformability and comfort during the application process, and reducing the problems of dressing detachment and edge lifting.

[0024] Through the synergistic effect of sodium hyaluronate and glycerin, a long-acting water-locking mechanism is provided to improve the skin moisture state and maintain the moist environment required for wound healing. As typical hydrophilic humectants, glycerin and propylene glycol can bidirectionally regulate the moisture in the stratum corneum of the skin, prevent moisture loss, and multiple moisturizing factors work together to build a "water absorption - water locking - slow release" triple moisturizing mechanism, significantly enhancing the water replenishment and moisturizing persistence of the patch. Carbomer is a high-molecular gel matrix with good rheological properties and film-forming properties, which can endow the patch with appropriate viscoelasticity. The pH regulator can control the charge density and network structure stability of carbomer, avoid water separation, delamination or collapse of the system, and enhance the stable adhesion ability of the patch under long-term use or dynamic conditions. Propylene glycol has both solvent and penetration-promoting functions, which can accelerate the release of active ingredients and improve the use effect; through the pH regulator and preservative, the activity stability and low irritation of the system during use are ensured, and the adaptability and safety to sensitive skin are enhanced. The gel layer is made of a variety of raw materials to ensure good transparency, soft touch and easy extensibility, and is skin-friendly, comfortable and non-greasy when used.

[0025] The purified water process can remove about 99% of inorganic salts, heavy metal ions and organic substances through reverse osmosis membranes, effectively avoiding chemical reactions between impurities and active ingredients, improving the stability and purity of the preparation, avoiding catalytic degradation by trace metal ions, and improving the preservation and service life of components such as sodium hyaluronate and glycerin. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 is a three-dimensional structural schematic diagram of the present invention;

[0027] Figure 2 is a method structural schematic diagram of the present invention.

[0028] Reference numerals: 1, surface film layer; 2, gel layer; 3, base support layer. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0029] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0030] Example 1

[0031] Reference Figure 1As shown in the figure, a highly moisturizing and repairing gel dressing includes a surface film layer 1, a gel layer 2, and a base support layer 3 from top to bottom. The surface film layer 1 is a polyurethane film, and the base support layer 3 is a non-woven fabric. It is characterized in that the gel layer 2 is made of the following raw materials and their weight percentages: sodium hyaluronate 0.3g, accounting for 0.1% - 0.5% of the total weight of the preparation; glycerol 10g, accounting for 5% - 15% of the total weight of the preparation; carbomer 0.2g, accounting for 1% - 5% of the total weight of the preparation; propylene glycol 3g, accounting for 2% - 8% of the total weight of the preparation; and the balance is purified water. A pH regulator and a preservative are added to the formula. The sodium hyaluronate and glycerol cooperate to provide a long-acting water-locking mechanism, improve the skin moisture state, and maintain the moist environment required for wound healing. Glycerol and propylene glycol, as typical hydrophilic moisturizers, can bidirectionally regulate the moisture in the skin cutin layer and prevent moisture loss. Multiple moisturizing factors cooperate to build a "water absorption - water locking - slow release" triple moisturizing mechanism, significantly improving the water replenishment and moisturizing persistence of the dressing. Carbomer is a polymer gel matrix with good rheological properties and film-forming properties, which can endow the dressing with appropriate viscoelasticity. The pH regulator can control the charge density and network structure stability of carbomer, avoid water separation, delamination or collapse of the system, and improve the stable adhesion ability of the dressing under long-term use or dynamic conditions. Propylene glycol has both solvent and penetration-promoting functions, which can accelerate the release of active ingredients and improve the use effect. The pH regulator and preservative ensure the active stability and low irritation of the system during use, improve the adaptability and safety to sensitive skin, and ensure that the gel layer has good transparency, soft touch and easy extensibility through the preparation of multiple raw materials, and is skin-friendly, comfortable and non-greasy when used.

[0032] Since the surface film layer is the outermost protective barrier of the dressing, its high moisture permeability and anti-permeability can effectively prevent the intrusion of external microorganisms, pollutants, dust particles, etc. into the wound surface or sensitive skin while ensuring local humidity control, providing a closed support for the internal gel layer. The gel layer is placed between the film layer and the support layer, carrying a variety of bioactive ingredients, forming a simulated moist environment, directly contacting the skin during use, quickly releasing moisturizing and repairing factors and regulating the microenvironment pH and moisture. Its good touch and rheological properties enable it to form a tight and soft contact interface with the skin surface. The base support layer, as the bottom carrier, provides structural support, tension buffering and overall strength enhancement for the gel layer, while improving the sticking stability, facilitating the user to wear it for a long time on multiple parts and dynamic skin surfaces without easy falling off or damage.

[0033] As a further solution of the present invention, the preparation method of the polyurethane film is as follows:

[0034] Dissolve the polyurethane resin in the solvent ethyl acetate, and plasticizers and surfactants can be added;

[0035] Uniformly coat the solution on the PET base film;

[0036] Heat and dry at 60-80 °C to volatilize the solvent and form a uniform transparent film;

[0037] Since the surface film layer is made of medical-grade polyurethane film material, it has good biocompatibility, flexibility and moisture vapor transmission rate (MVTR). While blocking external bacterial and particulate contamination, it allows the moisture generated by tissue metabolism to permeate out, thus constructing a closed and moisture-permeable "moist healing environment", which is conducive to epidermal cell migration and wound self-repair. At the same time, the base support layer 3 has good mechanical strength and flexibility, which can provide stable structural support for the gel layer 2 to prevent the gel from failing due to deformation, shear force or hydration swelling; It can be selected as breathable or airtight according to needs. Under specific designs, the base support layer 3 can be given multiple functions such as antibacterial, liquid absorption, anti-seepage or skin-friendly through coating treatment. At the same time, the polyurethane film has a certain degree of ductility and resilience, and can adapt to the minor deformations of the skin in different parts after application, improving the conformability and comfort during the application process, and reducing the problems of dressing detachment and edge warping.

[0038] As a further solution of the present invention, the preservative is a freshly prepared mixed liquid, which is compounded from methylparaben, ethylparaben, propylene glycol and the balance of water, and needs to be pre-dissolved in advance;

[0039] Compared with traditional synthetic preservatives, this plant-derived preservative combination has good stability in the pH range of 4-8 for methylparaben and ethylparaben (collectively called parabens), can effectively inhibit bacteria, molds and yeasts, and can significantly extend the safe use period of the product; Since propylene glycol not only helps the above preservatives to be evenly distributed in the entire aqueous phase system, but also can improve skin permeability and enhance the antibacterial activity of the preservative components at the contact interface between the dressing surface layer and the skin. At the same time, it can avoid affecting the film-forming performance and transparency of the gel, and ensure the texture and stability of the finished product.

[0040] As a further solution of the present invention, the pH regulator is triethanolamine, which is of pharmaceutical grade and is used to buffer and adjust the pH value of the gel layer to between 4.5 and 7.5 to ensure formulation stability and skin adaptability;

[0041] Since triethanolamine can effectively adjust and buffer the pH of the gel system to between 4.5 and 7.5, the system can maintain relative stability of acidity and alkalinity during the preparation and storage processes; It can prevent the phenomena of gel water separation, thinning or precipitation caused by pH changes, enhance the storage stability of the product, and at the same time reduce the irritation to the skin caused by alkaline raw materials, improve the skin-friendly nature and comfort of the product, and is especially suitable for sensitive skin or wound repair;

[0042] Using pharmaceutical-grade triethanolamine, the impurity content is lower, and the limits of heavy metals, nitrosamines, etc. meet the pharmacopoeia standards, and it has little effect on the activity of sensitive components such as fragrances and preservatives, which helps to maintain the overall performance of the product.

[0043] As a further solution of the present invention, the purified water is produced by a combined process of physical filtration + reverse osmosis + disinfection and sterilization. The reverse osmosis membrane is used to remove about 99% of ions and organic substances, and the remaining ions and microorganisms can be removed after microfiltration;

[0044] This combined process can remove about 99% of inorganic salts, heavy metal ions and organic substances through the reverse osmosis membrane, effectively avoiding chemical reactions between impurities and active ingredients, improving the stability and purity of the preparation, avoiding catalytic degradation by trace metal ions, and improving the preservation and service life of ingredients such as sodium hyaluronate and glycerol; through physical filtration and microfiltration membrane precision filtration (such as 0.22μm) technology, the microbial load of bacteria, molds, spores, etc. in water can be significantly reduced; combined with disinfection and sterilization processes (such as ultraviolet, ozone, pasteurization, etc.), the microbial safety of the product can be improved, meeting the requirements of sterile / antibacterial dressings. High-purity water can reduce the presence of potential irritants (such as residual chlorine and metabolites of miscellaneous bacteria), helping to improve the mildness and biocompatibility of the gel formula with the skin, being applicable to sensitive skin and wound repair. At the same time, it helps to ensure the uniform dispersion and dissolution of polymer materials such as carbomer, improving the film-forming property, consistency and appearance quality of the gel.

[0045] Example Two

[0046] Reference Figure 2 As shown, a preparation method of a highly moisturizing and repairing gel dressing includes the following steps:

[0047] S1: Dissolve carbomer in purified water at 80°C and stir to form a homogeneous solution;

[0048] S2: When the temperature drops to 40°C - 50°C, sequentially add glycerol, sodium hyaluronate, and preservative, and stir evenly at low speed;

[0049] S3: Add a pH regulator to the mixed solution and adjust the pH value to 5.5 - 6.5;

[0050] S4: After the temperature drops to room temperature, evenly coat the mixed solution on the support layer, then cover the surface film layer on the surface of the solution layer, and dry at low temperature for 24 hours to form a film;

[0051] S5: Cut into shape and perform aseptic packaging to obtain the product.

[0052] Although the embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions and variations can be made in these embodiments without departing from the principles and spirit of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A gel dressing for high moisturizing and repair, which sequentially comprises a surface film layer (1), a gel layer (2), and a base support layer (3) from top to bottom. The surface film layer (1) is a polyurethane film, and the base support layer (3) is a non-woven fabric. It is characterized in that, The gel layer (2) is made from the following raw materials and their weight percentages: sodium hyaluronate 0.3 g, accounting for 0.1% - 0.5% of the total weight of the preparation; glycerol 10 g, accounting for 5% - 15% of the total weight of the preparation; carbomer 0.2 g, accounting for 1% - 5% of the total weight of the preparation; propylene glycol 3 g, accounting for 2% - 8% of the total weight of the preparation; and the balance being purified water. A pH regulator and a preservative are additionally added to the formula.

2. The gel dressing for high moisturizing and repair according to claim 1, characterized in that, The preparation method of the polyurethane film is as follows: Dissolve the polyurethane resin in the solvent ethyl acetate, and a plasticizer and a surfactant may be added; Uniformly coat the solution on a PET base film; Heat and dry at 60 - 80 °C to volatilize the solvent and form a uniform transparent film, thus obtaining the product.

3. The gel dressing for high moisturizing and repair according to claim 1, characterized in that, The preservative is a freshly prepared mixed liquid, which is compounded from methylparaben, ethylparaben, propylene glycol and the balance of water, and needs to be pre-dissolved in advance.

4. The gel patch for high moisturizing and repair according to claim 1, wherein The pH regulator is triethanolamine, which is of pharmaceutical grade and is used to buffer and adjust the pH value of the gel layer to between 4.5 and 7.5 to ensure the stability of the formula and the skin adaptability.

5. A high-moisture-repairing gel patch according to claim 1, characterized in that, The purified water is obtained by a combined process of physical filtration + reverse osmosis + disinfection and sterilization. About 99% of ions and organic substances are removed by the reverse osmosis membrane, and the remaining ions and microorganisms can be removed after microfiltration.

6. A preparation method of a highly moisturizing and repairing gel dressing, characterized in that, The preparation method includes the following steps: S1: Dissolve carbomer in purified water at 80 °C, stir to dissolve and form a uniform solution; S2: When the temperature drops to 40 °C - 50 °C, successively add glycerol, sodium hyaluronate, and the preservative, and stir evenly at a low speed; S3: Add the pH regulator to the mixed solution and adjust the pH value to 5.5 - 6.5; S4: After the temperature drops to room temperature, uniformly coat the mixed solution on the support layer, then cover the surface film layer on the surface of the solution layer, and dry at a low temperature for 24 hours to form a film; S5: Cut and shape, and perform aseptic packaging to obtain the product.

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