Skin patch for promoting wound healing after cesarean section and preparation method thereof

Abstract

The invention discloses a skin patch for promoting wound healing after cesarean section and a preparation method thereof, the patch is composed of a multi-layer structure, and comprises a release film, a medical bandage bottom layer, a biological material layer, an electret functional layer and a breathable waterproof covering layer. The biological material layer contains fibroin, sodium alginate and medicinal plant extract components, and has the characteristics of resisting inflammation, resisting bacteria and promoting blood circulation and cell regeneration. The medical bandage bottom layer is made of pure cotton or elastic non-woven fabric and is breathable and comfortable. The electret functional layer is prepared through a special process, and the electret performance of PTFE is enhanced. The breathable waterproof covering layer is made of TPU materials, so that breathability and waterproofness are guaranteed. The preparation method comprises the following steps: preparing the medical bandage bottom layer, the biological material layer, the electret functional layer and the breathable waterproof covering layer, sequentially combining the layers, and finally treating and packaging a finished product. The skin patch effectively promotes wound healing after cesarean section through the synergistic effect of a multi-layer structure, and the living quality of a patient is improved.

Description

Technical Field

[0001] The invention belongs to the field of obstetrics and gynecology nursing, and specifically discloses a skin patch for promoting wound healing after caesarean section and a preparation method thereof. Background Art

[0002] Cesarean sections, as a common method of delivery, can effectively address certain delivery challenges, but postoperative wound care and recovery present a significant challenge for mothers. Due to the depth and breadth of the incision, cesarean section wounds often require a long recovery period and are prone to complications such as infection and inflammation, causing significant inconvenience and pain for mothers. Therefore, how to effectively promote wound healing and reduce complications after cesarean sections has become a pressing medical issue.

[0003] Traditionally, cesarean section wound care has relied primarily on disinfection, dressing changes, and the use of antibiotics. However, while these methods can prevent infection to a certain extent, they are limited in promoting wound healing, alleviating pain, and reducing scarring. Furthermore, frequent dressing changes not only increase the difficulty of wound care but may also cause secondary damage to the wound.

[0004] With the continuous advancement of materials science and biotechnology, researchers have begun exploring the use of novel materials and technologies to create specialized wound care products. Among these, skin patches have gradually gained attention as a convenient and effective wound care method. However, most existing skin patches only provide simple coverage and protection, lacking specific designs tailored to the unique needs of cesarean section wounds.

[0005] For example, while some skin patches offer a certain degree of breathability, they often fail to effectively prevent the intrusion of moisture and bacteria, increasing the risk of infection. Other patches, while containing drug ingredients, often struggle to achieve sustained and precise drug release, impacting therapeutic efficacy. Therefore, there is an urgent need for a skin patch that can effectively protect wounds and prevent infection, while also promoting wound healing and alleviating pain. Summary of the Invention

[0006] In view of the deficiencies in the prior art, the present invention provides a skin patch for promoting wound healing after cesarean section and a preparation method thereof.

[0007] The present invention includes the following technical solutions:

[0008] A skin patch for promoting wound healing after cesarean section, the patch is composed of a multi-layer structure, which sequentially comprises:

[0009] 1) Release film:

[0010] 2) The bottom layer of the medical bandage is coated with a skin-friendly and non-toxic adhesive and covered with a release film:

[0011] 3) a biomaterial layer comprising silk fibroin, sodium alginate, and medicinal plant extracts, wherein the medicinal plant extracts are selected from plants having anti-inflammatory, antibacterial, blood circulation promoting, and cell regeneration promoting properties, including one or more of Panax notoginseng, Angelica sinensis, honeysuckle, astragalus, and coptis chinensis;

[0012] 4) electret functional layer;

[0013] 5) Breathable waterproof cover.

[0014] Furthermore, in the above-mentioned skin patch for promoting wound healing after cesarean section, the material of the bottom layer of the medical bandage is pure cotton or elastic non-woven fabric.

[0015] Furthermore, in the above-mentioned skin patch for promoting wound healing after cesarean section, the biomaterial layer is composed of the following materials in parts by weight:

[0016]

[0017] Furthermore, in the above-mentioned skin patch for promoting wound healing after cesarean section, the Panax notoginseng extract is prepared by the following steps:

[0018] 1) Raw material processing: Panax notoginseng rhizomes were selected as raw materials, sorted, washed, dried and crushed, and passed through a 100-mesh sieve to obtain Panax notoginseng powder;

[0019] 2) Ethanol extraction:

[0020] Solvent selection: Use 70% to 95% ethanol as the extraction solvent;

[0021] Extraction conditions: Mix Panax notoginseng powder with ethanol at a ratio of 1:5-10g / ml and perform reflux extraction; the extraction time is 1.5-2.5h, and the extraction temperature is controlled at 70-80℃ to promote the full dissolution of the active ingredients;

[0022] 3) Filtration and concentration:

[0023] Filtration: After the extraction is completed, the extract is centrifuged at 3000-5000g; filtered through gauze and the supernatant is taken to remove the residue and impurities;

[0024] Concentration: Concentrate the filtered extract at 60-72°C until the specific gravity of the extract reaches 1.06 to 1.09;

[0025] 4) Macroporous resin adsorption:

[0026] Resin selection: Use D101 macroporous resin or;

[0027] Adsorption conditions: The concentrated extract is passed through a macroporous resin column for adsorption to remove some impurities; the amount of resin used is 10-15 times the mass of the extract;

[0028] 5) Elution and collection:

[0029] Eluent selection: Use 70% to 80% ethanol;

[0030] Elution and collection: First elute impurities with 5-10 times the volume of resin in water, then elute with 3-6 times the volume of resin in ethanol, and collect the ethanol eluate;

[0031] 6) Drying and testing

[0032] Drying: The collected ethanol eluate is subjected to ethanol recovery and vacuum drying to obtain the Panax notoginseng extract.

[0033] Furthermore, in the above-mentioned skin patch for promoting wound healing after cesarean section, the biomaterial layer is prepared by the following steps:

[0034] a. Weigh the raw materials by weight:

[0035] b. placing polylactic acid in a melt extruder and heating it to a molten state to form a molten polylactic acid matrix;

[0036] c. Add silk fibroin, sodium alginate, chitosan, and collagen to sterile water at a ratio of 1:5-10 g / ml and stir to obtain a mixture;

[0037] d. The Panax notoginseng extract, Angelica extract and honeysuckle extract were added to the mixed solution of step c and stirred thoroughly to form a mixture containing Chinese herbal extracts;

[0038] e. The mixture containing the herbal extract obtained in step d is evenly coated or sprayed on the molten polylactic acid matrix obtained in step 2, and allowed to dry naturally to obtain a biomaterial layer for standby use.

[0039] Furthermore, in the above-mentioned skin patch for promoting wound healing after cesarean section, the electret functional layer is prepared by the following steps:

[0040] I. Solution Preparation:

[0041] Add PTFE powder to xylene at a ratio of 1:5-10 g / ml; stir and mix at room temperature until the PTFE powder is completely dissolved to form a uniform PTFE solution;

[0042] II. Coating molding:

[0043] Use a coating machine to evenly coat the PTFE solution on the base material PET film, controlling the coating thickness to 10-50μm;

[0044] III. Drying and curing:

[0045] Place the coated substrate in an oven and dry it at 80-90°C for 2-4 hours to remove the xylene solvent and fix the PTFE layer.

[0046] IV. Charge Injection and Polarization:

[0047] The cured PTFE layer was charged using a corona discharge device with an injection volume of 50-100 microcoulombs / cm2;

[0048] After the charge is injected, a polarization treatment is performed at a temperature of 120-130°C for 1-2 hours with an electric field strength of 1000-5000V / cm to enhance the electret properties of PTFE.

[0049] V post-processing:

[0050] The electret functional layer after polarization is peeled off from the base material, surface residues are cleaned and removed, and the electret functional layer is dried at room temperature to obtain the electret functional layer.

[0051] Furthermore, in the above-mentioned skin patch for promoting wound healing after cesarean section, the breathable and waterproof covering layer is made of TPU material.

[0052] The present invention also discloses a method for preparing the skin patch, comprising the following steps:

[0053] S1 Preparation of the bottom layer of medical bandage:

[0054] Cut the medical bandage material into the required size; evenly apply skin-friendly and non-toxic adhesive around the bandage and cover it with a release film to prevent the adhesive from sticking to other items;

[0055] S2 Preparation of biomaterial layer:

[0056] Apply the side of the biomaterial layer containing the Chinese medicine extract to the bottom layer of the medical bandage

[0057] S3 preparation of electret functional layer:

[0058] Cover the electret functional layer on the polylactic acid matrix of the biomaterial layer and press gently to ensure a tight fit between the two layers;

[0059] S4 Preparation Breathable Waterproof Cover:

[0060] Cutting the breathable and waterproof covering layer material into a size that is the same as or slightly larger than the electret functional layer;

[0061] Completely covering the electret functional layer with a breathable and waterproof covering layer and firmly bonding it to the underlying material using a hot melt bonding method to obtain a patch;

[0062] S5 finished product processing and packaging:

[0063] The prepared skin patch is trimmed and arranged as necessary to ensure that its edges are flat and flawless, and the skin patch is placed in a sterile package and sealed.

[0064] Compared with the prior art, the present invention has the following beneficial effects:

[0065] The present invention provides a skin patch that promotes wound healing after caesarean section. Its unique multi-layer structure design integrates a medical bandage bottom layer, a biomaterial layer rich in a variety of medicinal plant essences, an innovative electret functional layer, and a breathable and waterproof covering layer; the electret functional layer is tightly combined with the biomaterial layer to act together on the wound. The medicinal plant extract components (such as Panax notoginseng, Angelica sinensis, honeysuckle, etc.) in the biomaterial layer have anti-inflammatory, antibacterial, blood circulation and cell regeneration properties, which are crucial for wound healing. The electret functional layer further promotes the penetration of these active ingredients into the wound tissue through its unique electrostatic field and microcurrent effect, significantly accelerates the wound healing process, reduces scar formation, and improves the patient's quality of life. At the same time, the patch preparation method is scientific and easy to operate, and the finished product is easy to use, safe and effective, providing a new and efficient solution for wound care after caesarean section, with significant clinical application potential and social value. BRIEF DESCRIPTION OF THE DRAWINGS

[0066] Figure 1 is a schematic top view of the patch of the present invention;

[0067] Figure 2 Schematic diagram of the structural layers of the patch of the present invention;

[0068] Figure 3 This is a comparison chart of wound areas in the test case;

[0069] Figure 4 Comparison chart of healing time for test cases. DETAILED DESCRIPTION

[0070] like Figure 1-2 A skin patch for promoting wound healing after cesarean section is shown. The patch is composed of a multi-layer structure, which sequentially includes:

[0071] 1) Release film:

[0072] 2) The bottom layer of the medical bandage is coated with a skin-friendly and non-toxic adhesive and covered with a release film:

[0073] 3) a biomaterial layer comprising silk fibroin, sodium alginate, and medicinal plant extracts, wherein the medicinal plant extracts are selected from plants having anti-inflammatory, antibacterial, blood circulation promoting, and cell regeneration promoting properties, including one or more of Panax notoginseng, Angelica sinensis, honeysuckle, astragalus, and coptis chinensis;

[0074] 4) electret functional layer;

[0075] 5) Breathable waterproof cover.

[0076] The bottom layer of the medical bandage is made of elastic non-woven fabric;

[0077] The biomaterial layer is composed of the following materials in parts by weight:

[0078]

[0079] The Panax notoginseng extract can be purchased as a commercial product, or can be prepared by the following steps:

[0080] 1) Raw material processing: Panax notoginseng rhizomes were selected as raw materials, sorted, washed, dried and crushed, and passed through a 100-mesh sieve to obtain Panax notoginseng powder;

[0081] 2) Ethanol extraction:

[0082] Solvent selection: Use 70% to 95% ethanol as the extraction solvent;

[0083] Extraction conditions: Mix Panax notoginseng powder with ethanol at a ratio of 1:5-10g / ml and perform reflux extraction; the extraction time is 1.5-2.5h, and the extraction temperature is controlled at 70-80℃ to promote the full dissolution of the active ingredients;

[0084] 3) Filtration and concentration:

[0085] Filtration: After the extraction is completed, the extract is centrifuged at 3000-5000g; filtered through gauze and the supernatant is taken to remove the residue and impurities;

[0086] Concentration: Concentrate the filtered extract at 60-72°C until the specific gravity of the extract reaches 1.06 to 1.09;

[0087] 4) Macroporous resin adsorption:

[0088] Resin selection: Use D101 macroporous resin or;

[0089] Adsorption conditions: The concentrated extract is passed through a macroporous resin column for adsorption to remove some impurities; the amount of resin used is 10-15 times the mass of the extract;

[0090] 5) Elution and collection:

[0091] Eluent selection: Use 70% to 80% ethanol;

[0092] Elution and collection: First elute impurities with 5-10 times the volume of resin in water, then elute with 3-6 times the volume of resin in ethanol, and collect the ethanol eluate;

[0093] 6) Drying and testing

[0094] Drying: The collected ethanol eluate is subjected to ethanol recovery and vacuum drying to obtain the Panax notoginseng extract.

[0095] The biomaterial layer is prepared by the following steps:

[0096] a. Weigh the raw materials by weight:

[0097] b. placing polylactic acid in a melt extruder and heating it to a molten state to form a molten polylactic acid matrix;

[0098] c. Add silk fibroin, sodium alginate, chitosan, and collagen to sterile water at a ratio of 1:8 g / ml and stir to obtain a mixture;

[0099] d. The Panax notoginseng extract, Angelica extract and honeysuckle extract were added to the mixed solution of step c and stirred thoroughly to form a mixture containing Chinese herbal extracts;

[0100] e. The mixture containing the herbal extract obtained in step d is evenly coated or sprayed on the molten polylactic acid matrix obtained in step 2, and allowed to dry naturally to obtain a biomaterial layer for standby use.

[0101] The electret functional layer is prepared by the following steps:

[0102] I. Solution Preparation:

[0103] Add PTFE powder to xylene at a ratio of 1:8 g / ml; stir and mix at room temperature until the PTFE powder is completely dissolved to form a uniform PTFE solution;

[0104] II. Coating molding:

[0105] Use a coating machine to evenly coat the PTFE solution on the base material PET film, and control the coating thickness to be 25 μm;

[0106] III. Drying and curing:

[0107] The coated substrate was placed in an oven and dried at 85°C for 3 h to remove the xylene solvent and fix the PTFE layer.

[0108] IV. Charge Injection and Polarization:

[0109] The cured PTFE layer was charged with a corona discharge device at a charge level of 75 microcoulombs / cm2.

[0110] After charge injection, polarization treatment was performed at 125°C for 1.5 h with an electric field strength of 2500 V / cm to enhance the electret properties of PTFE.

[0111] V post-processing:

[0112] peeling the polarized electret functional layer from the base material, cleaning to remove surface residues, and drying at room temperature to obtain the electret functional layer;

[0113] The breathable and waterproof covering layer is made of TPU material;

[0114] The preparation method of the above-mentioned skin patch comprises the following steps:

[0115] S1 Preparation of the bottom layer of medical bandage:

[0116] Cut the medical bandage material into the required size; evenly apply skin-friendly and non-toxic adhesive around the bandage and cover it with a release film to prevent the adhesive from sticking to other items;

[0117] S2 Preparation of biomaterial layer:

[0118] Apply the side of the biomaterial layer containing the Chinese medicine extract to the bottom layer of the medical bandage

[0119] S3 preparation of electret functional layer:

[0120] Cover the electret functional layer on the polylactic acid matrix of the biomaterial layer and press gently to ensure a tight fit between the two layers;

[0121] S4 Preparation Breathable Waterproof Cover:

[0122] Cutting the breathable and waterproof covering layer material into a size that is the same as or slightly larger than the electret functional layer;

[0123] Completely covering the electret functional layer with a breathable and waterproof covering layer and firmly bonding it to the underlying material using a hot melt bonding method to obtain a patch;

[0124] S5 finished product processing and packaging:

[0125] The prepared skin patch is trimmed and arranged as necessary to ensure that its edges are flat and flawless, and the skin patch is placed in a sterile package and sealed.

[0126] The following is a clear and complete description of the technical solutions in the embodiments of the present invention. Obviously, the embodiments described are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making any creative efforts are within the scope of protection of the present invention.

[0127] The Panax notoginseng extract, Angelica sinensis extract and Honeysuckle Flos extract of Examples 1-3 were purchased commercially.

[0128] Example 1

[0129] A skin patch for promoting wound healing after cesarean section, the patch is composed of a multi-layer structure, which sequentially comprises:

[0130] 1) Release film:

[0131] 2) The bottom layer of the medical bandage is coated with a skin-friendly and non-toxic adhesive and covered with a release film:

[0132] 3) a biomaterial layer comprising silk fibroin, sodium alginate, and medicinal plant extracts, wherein the medicinal plant extracts are selected from plants having anti-inflammatory, antibacterial, blood circulation promoting, and cell regeneration promoting properties, including one or more of Panax notoginseng, Angelica sinensis, honeysuckle, astragalus, and coptis chinensis;

[0133] 4) electret functional layer;

[0134] 5) Breathable waterproof cover.

[0135] The bottom layer of the medical bandage is made of elastic non-woven fabric;

[0136] The biomaterial layer is composed of the following materials in parts by weight:

[0137]

[0138] The biomaterial layer is prepared by the following steps:

[0139] a. Weigh the raw materials by weight:

[0140] b. placing polylactic acid in a melt extruder and heating it to a molten state to form a molten polylactic acid matrix;

[0141] c. Add silk fibroin, sodium alginate, chitosan, and collagen to sterile water at a ratio of 1:8 g / ml and stir to obtain a mixture;

[0142] d. The Panax notoginseng extract, Angelica extract and honeysuckle extract were added to the mixed solution of step c and stirred thoroughly to form a mixture containing Chinese herbal extracts;

[0143] e. The mixture containing the herbal extract obtained in step d is evenly coated or sprayed on the molten polylactic acid matrix obtained in step 2, and allowed to dry naturally to obtain a biomaterial layer for standby use.

[0144] The electret functional layer is prepared by the following steps:

[0145] I. Solution Preparation:

[0146] Add PTFE powder to xylene at a ratio of 1:8 g / ml; stir and mix at room temperature until the PTFE powder is completely dissolved to form a uniform PTFE solution;

[0147] II. Coating molding:

[0148] Use a coating machine to evenly coat the PTFE solution on the base material PET film, and control the coating thickness to be 25 μm;

[0149] III. Drying and curing:

[0150] The coated substrate was placed in an oven and dried at 85°C for 3 h to remove the xylene solvent and fix the PTFE layer.

[0151] IV. Charge Injection and Polarization:

[0152] The cured PTFE layer was charged with a corona discharge device at a charge level of 75 microcoulombs / cm2.

[0153] After charge injection, polarization treatment was performed at 125°C for 1.5 h with an electric field strength of 2500 V / cm to enhance the electret properties of PTFE.

[0154] V post-processing:

[0155] peeling the polarized electret functional layer from the base material, cleaning to remove surface residues, and drying at room temperature to obtain the electret functional layer;

[0156] The breathable and waterproof covering layer is made of TPU material;

[0157] The preparation method of the above-mentioned skin patch comprises the following steps:

[0158] S1 Preparation of the bottom layer of medical bandage:

[0159] Cut the medical bandage material into the required size; evenly apply skin-friendly and non-toxic adhesive around the bandage and cover it with a release film to prevent the adhesive from sticking to other items;

[0160] S2 Preparation of biomaterial layer:

[0161] Apply the side of the biomaterial layer containing the Chinese medicine extract to the bottom layer of the medical bandage

[0162] S3 preparation of electret functional layer:

[0163] Cover the electret functional layer on the polylactic acid matrix of the biomaterial layer and press gently to ensure a tight fit between the two layers;

[0164] S4 Preparation Breathable Waterproof Cover:

[0165] Cutting the breathable and waterproof covering layer material into a size that is the same as or slightly larger than the electret functional layer;

[0166] Completely covering the electret functional layer with a breathable and waterproof covering layer and firmly bonding it to the underlying material using a hot melt bonding method to obtain a patch;

[0167] S5 finished product processing and packaging:

[0168] The prepared skin patch is trimmed and arranged as necessary to ensure that its edges are flat and flawless, and the skin patch is placed in a sterile package and sealed.

[0169] Example 2

[0170] A skin patch for promoting wound healing after cesarean section, the patch is composed of a multi-layer structure, which sequentially comprises:

[0171] 1) Release film:

[0172] 2) The bottom layer of the medical bandage is coated with a skin-friendly and non-toxic adhesive and covered with a release film:

[0173] 3) a biomaterial layer comprising silk fibroin, sodium alginate, and medicinal plant extracts, wherein the medicinal plant extracts are selected from plants having anti-inflammatory, antibacterial, blood circulation promoting, and cell regeneration promoting properties, including one or more of Panax notoginseng, Angelica sinensis, honeysuckle, astragalus, and coptis chinensis;

[0174] 4) electret functional layer;

[0175] 5) Breathable waterproof cover.

[0176] The bottom layer of the medical bandage is made of elastic non-woven fabric;

[0177] The biomaterial layer is composed of the following materials in parts by weight:

[0178] 100 parts of polylactic acid

[0179] 4.5 parts of silk fibroin

[0180] 15 parts of sodium alginate

[0181] 20 parts of chitosan

[0182] 7.5 parts collagen

[0183] 4.5 parts of Panax notoginseng extract

[0184] 7.5 parts of Angelica Extract

[0185] 3 parts of honeysuckle extract.

[0186] The biomaterial layer is prepared by the following steps:

[0187] a. Weigh the raw materials by weight:

[0188] b. placing polylactic acid in a melt extruder and heating it to a molten state to form a molten polylactic acid matrix;

[0189] c. Add silk fibroin, sodium alginate, chitosan, and collagen to sterile water at a ratio of 1:8 g / ml and stir to obtain a mixture;

[0190] d. The Panax notoginseng extract, Angelica extract and honeysuckle extract were added to the mixed solution of step c and stirred thoroughly to form a mixture containing Chinese herbal extracts;

[0191] e. The mixture containing the herbal extract obtained in step d is evenly coated or sprayed on the molten polylactic acid matrix obtained in step 2, and allowed to dry naturally to obtain a biomaterial layer for standby use.

[0192] The electret functional layer is prepared by the following steps:

[0193] I. Solution Preparation:

[0194] Add PTFE powder to xylene at a ratio of 1:8 g / ml; stir and mix at room temperature until the PTFE powder is completely dissolved to form a uniform PTFE solution;

[0195] II. Coating molding:

[0196] Use a coating machine to evenly coat the PTFE solution on the base material PET film, and control the coating thickness to be 25 μm;

[0197] III. Drying and curing:

[0198] The coated substrate was placed in an oven and dried at 85°C for 3 h to remove the xylene solvent and fix the PTFE layer.

[0199] IV. Charge Injection and Polarization:

[0200] The cured PTFE layer was charged with a corona discharge device at a charge level of 75 microcoulombs / cm2.

[0201] After charge injection, polarization treatment was performed at 125°C for 1.5 h with an electric field strength of 2500 V / cm to enhance the electret properties of PTFE.

[0202] V post-processing:

[0203] peeling the polarized electret functional layer from the base material, cleaning to remove surface residues, and drying at room temperature to obtain the electret functional layer;

[0204] The breathable and waterproof covering layer is made of TPU material;

[0205] The preparation method of the above-mentioned skin patch comprises the following steps:

[0206] S1 Preparation of the bottom layer of medical bandage:

[0207] Cut the medical bandage material into the required size; evenly apply skin-friendly and non-toxic adhesive around the bandage and cover it with a release film to prevent the adhesive from sticking to other items;

[0208] S2 Preparation of biomaterial layer:

[0209] Apply the side of the biomaterial layer containing the Chinese medicine extract to the bottom layer of the medical bandage

[0210] S3 preparation of electret functional layer:

[0211] Cover the electret functional layer on the polylactic acid matrix of the biomaterial layer and press gently to ensure a tight fit between the two layers;

[0212] S4 Preparation Breathable Waterproof Cover:

[0213] Cutting the breathable and waterproof covering layer material into a size that is the same as or slightly larger than the electret functional layer;

[0214] Completely covering the electret functional layer with a breathable and waterproof covering layer and firmly bonding it to the underlying material using a hot melt bonding method to obtain a patch;

[0215] S5 finished product processing and packaging:

[0216] The prepared skin patch is trimmed and arranged as necessary to ensure that its edges are flat and flawless, and the skin patch is placed in a sterile package and sealed.

[0217] Example 3

[0218] A skin patch for promoting wound healing after cesarean section, the patch is composed of a multi-layer structure, which sequentially comprises:

[0219] 1) Release film:

[0220] 2) The bottom layer of the medical bandage is coated with a skin-friendly and non-toxic adhesive and covered with a release film:

[0221] 3) a biomaterial layer comprising silk fibroin, sodium alginate, and medicinal plant extracts, wherein the medicinal plant extracts are selected from plants having anti-inflammatory, antibacterial, blood circulation promoting, and cell regeneration promoting properties, including one or more of Panax notoginseng, Angelica sinensis, honeysuckle, astragalus, and coptis chinensis;

[0222] 4) electret functional layer;

[0223] 5) Breathable waterproof cover.

[0224] The bottom layer of the medical bandage is made of elastic non-woven fabric;

[0225] The biomaterial layer is composed of the following materials in parts by weight:

[0226]

[0227] The biomaterial layer is prepared by the following steps:

[0228] a. Weigh the raw materials by weight:

[0229] b. placing polylactic acid in a melt extruder and heating it to a molten state to form a molten polylactic acid matrix;

[0230] c. Add silk fibroin, sodium alginate, chitosan, and collagen to sterile water at a ratio of 1:8 g / ml and stir to obtain a mixture;

[0231] d. The Panax notoginseng extract, Angelica extract and honeysuckle extract were added to the mixed solution of step c and stirred thoroughly to form a mixture containing Chinese herbal extracts;

[0232] e. The mixture containing the herbal extract obtained in step d is evenly coated or sprayed on the molten polylactic acid matrix obtained in step 2, and allowed to dry naturally to obtain a biomaterial layer for standby use.

[0233] The electret functional layer is prepared by the following steps:

[0234] I. Solution Preparation:

[0235] Add PTFE powder (polytetrafluoroethylene powder) to xylene at a ratio of 1:8 g / ml; stir and mix at room temperature until the PTFE powder is completely dissolved to form a uniform PTFE solution;

[0236] II. Coating molding:

[0237] Use a coating machine to evenly coat the PTFE solution on the base material PET film, and control the coating thickness to be 25 μm;

[0238] III. Drying and curing:

[0239] The coated substrate was placed in an oven and dried at 85°C for 3 h to remove the xylene solvent and fix the PTFE layer.

[0240] IV. Charge Injection and Polarization:

[0241] The cured PTFE layer was charged with a corona discharge device at a charge level of 75 microcoulombs / cm2.

[0242] After charge injection, polarization treatment was performed at 125°C for 1.5 h with an electric field strength of 2500 V / cm to enhance the electret properties of PTFE.

[0243] V post-processing:

[0244] peeling the polarized electret functional layer from the base material, cleaning to remove surface residues, and drying at room temperature to obtain the electret functional layer;

[0245] The breathable and waterproof covering layer is made of TPU material;

[0246] The preparation method of the above-mentioned skin patch comprises the following steps:

[0247] S1 Preparation of the bottom layer of medical bandage:

[0248] Cut the medical bandage material into the required size; evenly apply skin-friendly and non-toxic adhesive around the bandage and cover it with a release film to prevent the adhesive from sticking to other items;

[0249] S2 Preparation of biomaterial layer:

[0250] Apply the side of the biomaterial layer containing the Chinese medicine extract to the bottom layer of the medical bandage

[0251] S3 preparation of electret functional layer:

[0252] Cover the electret functional layer on the polylactic acid matrix of the biomaterial layer and press gently to ensure a tight fit between the two layers;

[0253] S4 Preparation Breathable Waterproof Cover:

[0254] Cutting the breathable and waterproof covering layer material into a size that is the same as or slightly larger than the electret functional layer;

[0255] Completely covering the electret functional layer with a breathable and waterproof covering layer and firmly bonding it to the underlying material using a hot melt bonding method to obtain a patch;

[0256] S5 finished product processing and packaging:

[0257] The prepared skin patch is trimmed and arranged as necessary to ensure that its edges are flat and flawless, and the skin patch is placed in a sterile package and sealed.

[0258] Example 4

[0259] The Panax notoginseng extract was prepared by the following method:

[0260] 1) Raw material processing: Panax notoginseng rhizomes were selected as raw materials, sorted, washed, dried and crushed, and passed through a 100-mesh sieve to obtain Panax notoginseng powder;

[0261] 2) Ethanol extraction:

[0262] Solvent selection: Use 70% to 95% ethanol as the extraction solvent;

[0263] Extraction conditions: Mix Panax notoginseng powder with ethanol at a ratio of 1:5-10g / ml and perform reflux extraction; the extraction time is 1.5-2.5h, and the extraction temperature is controlled at 70-80℃ to promote the full dissolution of the active ingredients;

[0264] 3) Filtration and concentration:

[0265] Filtration: After the extraction is completed, the extract is centrifuged at 3000-5000g; filtered through gauze and the supernatant is taken to remove the residue and impurities;

[0266] Concentration: Concentrate the filtered extract at 60-72°C until the specific gravity of the extract reaches 1.06 to 1.09;

[0267] 4) Macroporous resin adsorption:

[0268] Resin selection: Use D101 macroporous resin or;

[0269] Adsorption conditions: The concentrated extract is passed through a macroporous resin column for adsorption to remove some impurities; the amount of resin used is 10-15 times the mass of the extract;

[0270] 5) Elution and collection:

[0271] Eluent selection: Use 70% to 80% ethanol;

[0272] Elution and collection: First elute impurities with 5-10 times the volume of resin in water, then elute with 3-6 times the volume of resin in ethanol, and collect the ethanol eluate;

[0273] 6) Drying and testing

[0274] Drying: The collected ethanol eluate is subjected to ethanol recovery and vacuum drying to obtain the Panax notoginseng extract.

[0275] The rest is the same as Example 2.

[0276] Comparative Example 1

[0277] The method is the same as that in Example 2 except that it does not contain silk fibroin and sodium alginate.

[0278] Comparative Example 2

[0279] The extracts of Panax notoginseng, Angelica sinensis and honeysuckle are not contained, and the rest are the same as those in Example 2.

[0280] Comparative Example 3

[0281] It does not contain silk fibroin and sodium alginate, nor does it contain Panax notoginseng, Angelica sinensis and honeysuckle extracts. Other aspects are the same as those in Example 2.

[0282] Comparative Example 4

[0283] The electret functional layer is not included, and the rest is the same as in Example 2.

[0284] Comparative Example 5

[0285] Commercially available Band-Aids.

[0286] Test Case

[0287] Patches of Examples 1-4, Comparative Examples 1-4 (all 2x2 cm in size, with a medical bandage base layer of 0.3 mm thickness, a biomaterial layer of 1 g mass, and an electret functional layer of 25 μm), and Comparative Example 5 were tested. The tests were conducted on animals.

[0288] Animals: Adult male Wistar rats weighing 180-220 g were housed in an SPF barrier environment.

[0289] Surgical Procedure: After anesthesia, the rats underwent routine skin preparation and disinfection on the back. A 1.5 cm x 1.5 cm incision was made on the back, followed by routine hemostasis. On the day of surgery and for nine days after surgery, antibiotics were administered intramuscularly daily to prevent surgical site infection.

[0290] Grouping and drug administration:

[0291] On the day of surgery, the rats were randomly divided into 10 groups, with 10 rats in each group, including a control group that did not receive drug treatment. The rats were housed in single cages. The surgical site was initially covered with a patch, which was changed every 3 days. The wound healing and infection were observed every day during the experiment. The length and width of the skin wound of each group of rats were measured on the 9th day, and the wound area was calculated. The patch was then changed every 3 days. The time for complete wound healing was calculated for one month. The healing refers to the wound being filled with new granulation tissue and completely epithelialized. The results were averaged and are shown in Tables 1 and 2. Figure 3-4 shown.

[0292] Table 1 Wound healing status.

[0293]

[0294] As can be seen from the above table 1 data, the medicinal plant extract components (such as Radix Notoginseng, Radix Angelicae Sinensis, Flos Lonicerae etc.) in the embodiment of the present invention 1-4 biomaterial layer have anti-inflammatory, antibacterial, promote blood circulation and cell regeneration and other characteristics, which are very important for wound healing. And the electret functional layer, by its unique electrostatic field and microcurrent effect, further promotes the infiltration of these active ingredients to wound tissue, significantly accelerates the healing process of the wound, and alleviates scar formation. Especially embodiment 4 uses homemade Radix Notoginseng extract, anti-inflammatory, and pro-healing function is better. As can be seen from comparative example 1-5, the patch of the present embodiment is compared with commercially available Band-Aid patch, and in healing time, scar situation, aspect healing time, all has huge progress. As can be seen from comparative example 1-4, natural protein, between Chinese medicine extract and the electret functional layer, produce obvious synergistic effect, promote wound healing.

[0295] The above are limited to several preferred embodiments of the present invention, and their description is relatively specific and detailed, but it should not be understood as limiting the scope of the present invention. It should be pointed out that those skilled in the art can make various modifications and improvements without departing from the scope of the present invention, and these modifications and improvements are all within the scope of protection of the present invention.

Claims

1. A skin patch for promoting wound healing after caesarean section, characterized in that: The patch consists of a multi-layer structure, which includes: 1) Release film: 2) The bottom layer of the medical bandage is coated with a skin-friendly and non-toxic adhesive and covered with a release film: 3) a biomaterial layer comprising silk fibroin, sodium alginate, and medicinal plant extracts, wherein the medicinal plant extracts are selected from plants having anti-inflammatory, antibacterial, blood circulation promoting, and cell regeneration promoting properties, including one or more of Panax notoginseng, Angelica sinensis, honeysuckle, astragalus, and coptis chinensis; 4) electret functional layer; 5) Breathable waterproof cover.

2. A skin patch for promoting wound healing after cesarean section according to claim 1, characterized in that: The bottom layer of the medical bandage is made of pure cotton or elastic non-woven fabric.

3. A skin patch for promoting wound healing after cesarean section according to claim 1, characterized in that: The biomaterial layer is composed of the following materials in parts by weight:

4. A skin patch for promoting wound healing after cesarean section according to claim 3, characterized in that: The Panax notoginseng extract is prepared by the following steps: 1) Raw material processing: Panax notoginseng rhizomes were selected as raw materials, sorted, washed, dried and crushed, and passed through a 100-mesh sieve to obtain Panax notoginseng powder; 2) Ethanol extraction: Solvent selection: Use 70% to 95% ethanol as the extraction solvent; Extraction conditions: Mix Panax notoginseng powder with ethanol at a ratio of 1:5-10g / ml and perform reflux extraction; the extraction time is 1.5-2.5h, and the extraction temperature is controlled at 70-80℃ to promote the full dissolution of the active ingredients; 3) Filtration and concentration: Filtration: After the extraction is completed, the extract is centrifuged at 3000-5000g; filtered through gauze and the supernatant is taken to remove the residue and impurities; Concentration: Concentrate the filtered extract at 60-72°C until the specific gravity of the extract reaches 1.06 to 1.09; 4) Macroporous resin adsorption: Resin selection: Use D101 macroporous resin or; Adsorption conditions: The concentrated extract is passed through a macroporous resin column for adsorption to remove some impurities; The amount of resin used is 10-15 times the mass of the extract; 5) Elution and collection: Eluent selection: Use 70% to 80% ethanol; Elution and collection: First elute impurities with 5-10 times the volume of resin in water, then elute with 3-6 times the volume of resin in ethanol, and collect the ethanol eluate; 6) Drying and testing Drying: The collected ethanol eluate is subjected to ethanol recovery and vacuum drying to obtain the Panax notoginseng extract.

5. The skin patch for promoting wound healing after cesarean section according to claim 3, characterized in that: The biomaterial layer is prepared by the following steps: a. Weigh the raw materials by weight: b. placing polylactic acid in a melt extruder and heating it to a molten state to form a molten polylactic acid matrix; c. Add silk fibroin, sodium alginate, chitosan, and collagen to sterile water at a ratio of 1:5-10 g / ml and stir to obtain a mixture; d. The Panax notoginseng extract, Angelica extract and honeysuckle extract were added to the mixed solution of step c and stirred thoroughly to form a mixture containing Chinese herbal extracts; e. The mixture containing the herbal extract obtained in step d is evenly coated or sprayed on the molten polylactic acid matrix obtained in step 2, and allowed to dry naturally to obtain a biomaterial layer for standby use.

6. The skin patch for promoting wound healing after cesarean section according to claim 1, characterized in that: The electret functional layer is prepared by the following steps: I. Solution Preparation: Add PTFE powder to xylene at a ratio of 1:5-10 g / ml; stir and mix at room temperature until the PTFE powder is completely dissolved to form a uniform PTFE solution; II. Coating molding: Use a coating machine to evenly coat the PTFE solution on the base material PET film, controlling the coating thickness to 10-50μm; III. Drying and curing: Place the coated substrate in an oven and dry it at 80-90°C for 2-4 hours to remove the xylene solvent and fix the PTFE layer. IV. Charge Injection and Polarization: The cured PTFE layer was charged using a corona discharge device with an injection volume of 50-100 microcoulombs / cm2; After charge injection, polarization treatment is performed at a temperature of 120-130°C for 1-2 hours with an electric field strength of 1000-5000V / cm to enhance the electret properties of PTFE; V post-processing: The electret functional layer after polarization is peeled off from the base material, surface residues are cleaned and removed, and the electret functional layer is dried at room temperature to obtain the electret functional layer.

7. The skin patch for promoting wound healing after cesarean section according to claim 1, characterized in that: The breathable and waterproof covering layer is made of TPU material.

8. The method for preparing the skin patch according to any one of claims 1 to 7, wherein: The following steps are involved: S1 Preparation of the bottom layer of medical bandage: Cut the medical bandage material into the required size; evenly apply skin-friendly and non-toxic adhesive around the bandage and cover it with a release film to prevent the adhesive from sticking to other items; S2 Preparation of biomaterial layer: Apply the side of the biomaterial layer containing the Chinese medicine extract to the bottom layer of the medical bandage S3 preparation of electret functional layer: Cover the electret functional layer on the polylactic acid matrix of the biomaterial layer and press gently to ensure a tight fit between the two layers; S4 Preparation Breathable Waterproof Cover: Cutting the breathable and waterproof covering layer material into a size that is the same as or slightly larger than the electret functional layer; Completely covering the electret functional layer with a breathable and waterproof covering layer and firmly bonding it to the underlying material using a hot melt bonding method to obtain a patch; S5 finished product processing and packaging: The prepared skin patch is trimmed and arranged as necessary to ensure that its edges are flat and flawless, and the skin patch is placed in a sterile package and sealed.

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