A bacteriostatic whole-cycle health-care traditional Chinese medicine compound combined preparation set and a use method thereof

Abstract

This invention relates to the field of pharmaceutical technology, specifically to a combination of traditional Chinese medicine (TCM) preparations for antibacterial and health-promoting treatment throughout the entire life cycle, and its method of use. The kit comprises three independent preparations: a rapid-release protective spray using Litsea cubeba essential oil nanoemulsion as a solvent, loaded with a compound alcoholic extract derived from Polygonum cuspidatum, Senecio scandens, Clematis chinensis, and Glycyrrhiza uralensis in a weight ratio of 4:3:1:1; a sustained-release repair gel patch using a thermosensitive poloxamer F127 and gelatin-sodium alginate double-network hydrogel as a matrix, encapsulating a concentrated aqueous extract obtained from freeze-dried powders of Polygonum cuspidatum, Portulaca oleracea, dried ginger, Bletilla striata, and honey in a weight ratio of 4:2:1:2:1; and a soluble healing-promoting bath film, a biodegradable film made from polyvinyl alcohol and carboxymethyl chitosan via a casting method, in which ultrafine powders of the core active pharmaceutical ingredient and nano-silver-bioglass composite material are dispersed. This application aims to construct a multi-layered, responsive product system from rapid protection to deep repair.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and more specifically, to a combination of traditional Chinese medicine preparations for antibacterial and health-promoting treatment throughout the entire life cycle, and its method of use. Background Technology

[0002] Currently, most topical products on the market for skin problems (such as intertrigo and diaper dermatitis) are single-formula products, such as antibacterial sprays, zinc oxide ointments, moisturizing and repairing creams, or ordinary gels containing traditional Chinese medicine ingredients. There are also some product combination sets, such as "lotion + ointment," but the components are usually developed independently with different formulation bases. In materials science, thermosensitive hydrogels (such as poloxamer) and soluble films (such as PVA films) have been used for drug delivery.

[0003] Existing products often only address symptoms, lacking a systematic design that addresses the entire "prevention-intervention-repair" cycle. For example, sprays only provide immediate antibacterial effects and lack long-term repair, while ointments are thick and unsuitable for daily prevention. Existing gels or ointments are mostly passively released and cannot intelligently adjust the drug release rate according to the skin environment (such as humidity, temperature, and pH). The active ingredients in different dosage forms are not based on their own properties, making it difficult to produce a synergistic effect of "1+1>2". Existing ointments are greasy and viscous, sprays provide uneven coverage, bath salts or bath liquids are inconvenient to carry, and the application of soluble films in medicated baths is rare. Existing products fail to provide a convenient, integrated solution from local to whole-body and from daily to deep treatment. High-end healing materials such as nano-silver and bio-glass are mostly used alone in dressings and have not been organically combined with traditional Chinese medicine formulas to create composite functional materials that combine antibacterial properties, regulate the microenvironment, and actively promote tissue regeneration. Existing technologies may use nanoemulsions, thermosensitive gels, or soluble films individually, but they have not been organically integrated with a unified treatment concept and core formulation.

[0004] This application addresses the shortcomings of existing technologies that lack a systematic approach to the entire "prevention-intervention-repair" cycle by providing a combination of antibacterial and health-promoting traditional Chinese medicine compound preparations and their usage methods. The aim is to construct a multi-level, responsive product system that ranges from rapid protection to deep repair. Summary of the Invention

[0005] The purpose of this invention is to provide a combination of antibacterial and health-preserving traditional Chinese medicine preparations and their usage method, which solves the shortcomings of existing technologies that lack a systematic approach to the entire "prevention-intervention-repair" cycle.

[0006] On one hand, embodiments of the present invention provide a combination of traditional Chinese medicine preparations for antibacterial and health-promoting treatment throughout the entire life cycle, comprising the following three independent preparations: The quick-release protective spray uses Litsea cubeba essential oil nanoemulsion as solvent and is loaded with a compound alcohol extract extracted from Polygonum cuspidatum, Senecio scandens, Clematis armandii, and Glycyrrhiza uralensis in a weight ratio of 4:3:1:1. The sustained-release repair gel patch uses thermosensitive poloxamer F127 and gelatin-sodium oxidized alginate double network hydrogel as the matrix, and encapsulates a compound water extract concentrate obtained by extracting and concentrating freeze-dried powders of Polygonum cuspidatum, Portulaca oleracea, dried ginger, Bletilla striata and honey in a weight ratio of 4:2:1:2:1. The soluble healing bath film is a biodegradable film made of polyvinyl alcohol and carboxymethyl chitosan by casting. It contains dispersed core medicinal component ultrafine powder and nano silver-bioglass composite material. The core medicinal component ultrafine powder includes Polygonum cuspidatum, Senecio scandens, Portulaca oleracea, dried ginger, Coptis chinensis, and Euphorbia humifusa.

[0007] Furthermore, in the quick-release protective spray, the particle size of the Litsea cubeba essential oil nanoemulsion is 50-200nm, the ethanol extraction concentration of the compound alcohol extract is 60%-80%, the dry extract accounts for 15%-30% of the total weight of the spray, and it contains 0.1%-0.5% menthol and 1%-3% pentanediol.

[0008] Furthermore, in the sustained-release repair gel patch, the concentration of thermosensitive poloxamer F127 is 18%-25%, the mass ratio of gelatin to sodium oxidized alginate is 2:1-1:1, the relative density of the compound aqueous extract concentrate is 1.10-1.20 (60℃), and its drug loading in the gel matrix is ​​10%-25% (w / w).

[0009] Furthermore, the gel patch matrix also contains 0.5%-2% carbomer to adjust adhesion and sustained-release profile; and 1%-3% erythritol as a moisturizing factor.

[0010] Furthermore, in the soluble healing bath membrane, the mass ratio of polyvinyl alcohol to carboxymethyl chitosan is 3:1-5:1, the membrane thickness is 0.05-0.15mm, the particle size D90 of the core active ingredient ultrafine powder is ≤20μm, accounting for 20%-40% of the membrane weight, and the nano-silver-bioglass composite material accounts for 1%-5% of the membrane weight.

[0011] Furthermore, in the aforementioned nano-silver-bioglass composite material, nano-silver is loaded onto porous bioactive glass microspheres in elemental form, with a silver content of 0.5%-2% (w / w).

[0012] Furthermore, the soluble healing bath film also contains 3%-8% by weight of triethyl citrate as a plasticizer, and 0.5%-1.5% of silica as an anti-caking agent and reinforcing agent.

[0013] On the other hand, a combination of antibacterial and whole-cycle health-preserving traditional Chinese medicine preparations is used in products for the prevention and care of intertrigo, diaper dermatitis, skin maceration, first- and second-degree burns, and skin barrier damage.

[0014] On the other hand, the method of using a combination of traditional Chinese medicine preparations for antibacterial and health-preserving treatment throughout the entire cycle is characterized by including the following stages: Daily protection phase: Spray the quick-release protective spray on areas prone to sweating and friction until slightly damp, forming a hydrophobic and antibacterial film. Use 2-4 times daily. Intensive repair phase: After cleansing the skin, cut the slow-release repair gel patch according to the area of ​​skin damage and apply it to the erythema, maceration or minor damage. Each application lasts 4-8 hours and is repeated 1-2 times daily. Deep health and wellness stage: When bathing, place 1-2 of the soluble healing bath films mentioned above in bathwater at 40-45℃, stir until completely dissolved, and take a full-body medicinal bath for 15-20 minutes, 2-3 times a week.

[0015] Furthermore, immediately after the medicated bath described in the deep conditioning phase, the application of patches described in the intensive repair phase is performed to enhance the local repair effect.

[0016] Compared with the prior art, the embodiments of the present invention have at least the following advantages or beneficial effects: 1. In this invention, the instant-release protective spray utilizes the potent, broad-spectrum antibacterial properties and rapid volatility of Litsea cubeba essential oil nanoemulsion, combined with the anti-inflammatory and astringent effects of traditional Chinese medicine alcohol extracts, to instantly form a breathable "invisible antibacterial film" on the surface of susceptible skin; its nanoparticle size ensures that the ingredients quickly penetrate the stratum corneum to exert an immediate effect, effectively preventing bacterial growth and initial inflammation caused by sweat, friction, and hot and humid environments, reducing the occurrence of problems from the source.

[0017] 2. The sustained-release repair gel patch of the present invention uses a thermosensitive poloxamer F127 and a gelatin-sodium alginate dual-network hydrogel; when applied to the skin (approximately 33-35°C), a sol-gel transition occurs, resulting in a tight fit without flow; its dual-network structure can efficiently load and continuously and slowly release repair ingredients (such as healing factors from Bletilla striata and honey) for several hours, providing a long-lasting moist repair microenvironment for damaged skin; the addition of carbomer further refines the adhesion and drug release curve, avoiding secondary damage during replacement.

[0018] 3. This invention employs different optimized compound formulas to address the core contradictions at different stages. The protective stage focuses on "clearing heat and drying dampness, inhibiting bacteria and reducing inflammation" (Polygonum cuspidatum, Senecio scandens, and Clematis armandii); the repair stage focuses on "clearing heat and astringing sores, promoting tissue regeneration and relieving pain" (Polygonum cuspidatum, Portulaca oleracea, Bletilla striata, and honey); and the health-preserving stage uses the most comprehensive "six-ingredient" core formula, taking into account all aspects. This "one formula for one symptom, one dosage for one type" design ensures highly precise efficacy for each dosage form. It incorporates active ingredients from traditional Chinese medicine, natural plant essential oils, and modern functional materials (nanotechnology). The synergistic effect of silver and bioglass (with multiple targets and mechanisms) creates a synergistic effect in antibacterial, anti-inflammatory, healing-promoting, and moisturizing properties, resulting in superior efficacy compared to any single ingredient or simple mixture. The sustained-release properties of the gel patch ensure a long-lasting and stable effect, while the nanoemulsion in the spray and the penetration enhancers in the gel (such as certain ingredients in the formula) work together to significantly improve the transdermal penetration efficiency of all active ingredients, especially macromolecules and lipid-soluble components, ensuring that the medicine "reaches, stays, and has a long-lasting effect."

[0019] 4. The soluble healing bath membrane of the present invention revolutionizes the traditional form of medicinal bath. The medicinal liquid formed after dissolution not only promotes blood circulation and removes dampness and toxins through systemic action, but the dispersed nano-silver-bioglass composite material can also work synergistically with the ultrafine powder of traditional Chinese medicine to exert strong antibacterial and anti-inflammatory effects at minimally invasive or inflamed sites and actively release ions (such as silicon and calcium ions) that promote tissue regeneration, thereby achieving systemic conditioning and strengthening from local to systemic levels. Detailed Implementation

[0020] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased commercially.

[0021] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other. The present invention will now be described in detail with reference to specific embodiments.

[0022] This invention provides a combination of three independent formulations of traditional Chinese medicine for antibacterial and health-promoting purposes, comprising a kit containing three separate formulations: The quick-release protective spray uses Litsea cubeba essential oil nanoemulsion as solvent and is loaded with a compound alcohol extract extracted from Polygonum cuspidatum, Senecio scandens, Clematis armandii, and Glycyrrhiza uralensis in a weight ratio of 4:3:1:1. The sustained-release repair gel patch uses thermosensitive poloxamer F127 and gelatin-sodium oxidized alginate double network hydrogel as the matrix, and encapsulates a compound water extract concentrate obtained by extracting and concentrating freeze-dried powders of Polygonum cuspidatum, Portulaca oleracea, dried ginger, Bletilla striata and honey in a weight ratio of 4:2:1:2:1. The soluble healing bath film is a biodegradable film made of polyvinyl alcohol and carboxymethyl chitosan by casting. It contains dispersed core medicinal component ultrafine powder and nano silver-bioglass composite material. The core medicinal component ultrafine powder includes Polygonum cuspidatum, Senecio scandens, Portulaca oleracea, dried ginger, Coptis chinensis, and Euphorbia humifusa.

[0023] In this embodiment of the invention, the instant-release protective spray establishes an immediate and proactive "first line of defense." Using Litsea cubeba essential oil nanoemulsion as a solvent, its nano-sized particles (50-200nm) greatly increase the specific surface area and skin permeability of the essential oil. Upon contact with the skin, it rapidly evaporates and penetrates, utilizing the potent broad-spectrum antibacterial properties of Litsea cubeba essential oil (mainly citral) to instantly form a breathable, hydrophobic antibacterial film on the skin surface. This isolates external microorganisms from both physical and chemical perspectives, making it suitable for areas prone to sweating and friction, effectively preventing intertrigo, diaper dermatitis, and other problems. The loaded compound alcohol extract (Polygonum cuspidatum, Senecio scandens, Clematis chinensis, Glycyrrhiza uralensis) is rich in polyphenols, alkaloids, and other components, possessing clear anti-inflammatory, antioxidant, and astringent effects. Synergistically with the essential oil, it can quickly relieve early, mild redness, itching, and other discomfort, strengthening the skin's defense capabilities and nipping problems in the bud. This sustained-release repair gel patch provides a long-lasting, intelligent "targeted repair chamber." The base uses thermosensitive poloxamer F127, which is liquid at room temperature for easy application. Upon contact with the skin, it rapidly transforms into a semi-solid gel due to the increased temperature (around 33°C), adhering closely to the contours of the lesion without flowing, creating a closed and moist repair environment. Combined with a gelatin-sodium alginate dual-network structure, it firmly encapsulates the compound water extracts (Polygonum cuspidatum, Portulaca oleracea, dried ginger, Bletilla striata, and honey), achieving continuous and slow release of active ingredients (up to 4-8 hours), maintaining an effective local drug concentration, and promoting repair. The contained traditional Chinese medicine compound (such as the gelatinous substance of Bletilla striata, various enzymes and nutrients in honey) and moisturizing factor (erythritol) work together to provide nutrition to the wound, promoting granulation tissue growth and epithelial cell migration, accelerating the healing of minor abrasions, maceration, or erythema. It is suitable for the "intensive repair phase" when definite skin lesions have appeared. The soluble healing bath film implements a comprehensive "holistic wellness regimen" for deep system treatment. When dissolved in warm water, the film forms a medicinal bath. Full-body immersion promotes capillary dilation and blood circulation, leveraging the heat-clearing, dampness-drying, blood-activating, and detoxifying effects of the ultra-fine powders of traditional Chinese medicine (including Polygonum cuspidatum, Senecio scandens, and six other herbs). It is particularly suitable for scenarios requiring large-area care or deep conditioning. The core component is a nano-silver-bioglass composite material dispersed within the film. Nano-silver provides a powerful and long-lasting antibacterial effect, preventing the risk of infection during immersion. The bioactive glass gradually releases calcium and silicon ions in the body fluid environment, actively regulating the local microenvironment and directly stimulating fibroblast proliferation and collagen synthesis. Synergistically working with the traditional Chinese medicine ingredients, it significantly accelerates the healing process of deeper wounds such as first- and second-degree burns and reduces scar formation.

[0024] Furthermore, in the quick-release protective spray, the particle size of the Litsea cubeba essential oil nanoemulsion is 50-200nm, the ethanol extraction concentration of the compound alcohol extract is 60%-80%, the dry extract accounts for 15%-30% of the total weight of the spray, and it contains 0.1%-0.5% menthol and 1%-3% pentanediol.

[0025] In this embodiment of the invention, the particle size range (50-200nm) of the Litsea cubeba essential oil nanoemulsion is the stable range of the nanoemulsion. Smaller particle size (nanoscale) means a huge specific surface area, which allows Litsea cubeba essential oil to disperse and contact the skin more quickly and evenly, significantly improving its transdermal penetration speed and efficiency. This is the physical basis for achieving "rapid release" and immediate effect. At the same time, the nanoemulsion system within this range is kinetically stable and not easy to separate, ensuring the stability of the product during storage. The ethanol extraction concentration (60%-80%) is the optimal range for extracting antibacterial and anti-inflammatory active ingredients (such as polyphenols and alkaloids) from medicinal materials such as Polygonum cuspidatum and Senecio scandens. If the concentration is too low, the extraction will be incomplete, and if it is too high, too many fat-soluble impurities may be dissolved. This optimized concentration ensures the purity and strength of the active ingredients in the extract. The drug loading design with a dry extract ratio (15%-30%) ensures that the spray contains a sufficiently high concentration of active ingredients to exert effective prevention and immediate soothing effects. Combined with nanoemulsion technology, it solves the problem that traditional high-concentration extracts may be sticky and difficult to absorb. Menthol (0.1%-0.5%) and pentylene glycol (1%-3%) provide an immediate cooling sensation, quickly relieving discomfort such as itching and burning, thus improving the user experience and compliance. Pentylene glycol is a multifunctional ingredient that acts as a highly effective moisturizer, helping to maintain the moisture of the stratum corneum at the application site. It is also a mild preservative, reducing the reliance on traditional preservatives in the formula and enhancing the product's gentleness and safety, making it especially suitable for sensitive or damaged skin.

[0026] Furthermore, in the sustained-release repair gel patch, the concentration of thermosensitive poloxamer F127 is 18%-25%, the mass ratio of gelatin to sodium oxidized alginate is 2:1-1:1, the relative density of the compound aqueous extract concentrate is 1.10-1.20 (60℃), and its drug loading in the gel matrix is ​​10%-25% (w / w).

[0027] In this embodiment of the invention, the concentration of poloxamer F127 (18%-25%) is the key concentration window for achieving its thermosensitive properties. Within this range, the formulation is a flowable sol at room temperature, which is easy to apply. After contact with the skin (about 33°C), it can quickly and reversibly transform into a semi-solid gel, which adheres closely to the skin lesion and does not flow, making it convenient to use and providing a comfortable experience. A high-performance dual-network hydrogel is constructed by using a mass ratio of gelatin to oxidized sodium alginate (2:1-1:1). Gelatin provides elasticity and biocompatibility, promoting cell adhesion; oxidized sodium alginate (usually referring to sodium alginate whose aldehyde content is increased through oxidation, facilitating cross-linking) provides mechanical strength and stability. The two work synergistically in this ratio, giving the gel patch both sufficient flexibility to conform to the body's contours and good cohesion and load-bearing capacity, enabling it to stably encapsulate high-water-content medications without leakage or collapse. The relative density (1.10-1.20) and drug loading (10%-25% w / w) of the compound aqueous extract concentrate ensure that the extract is moderately concentrated with a high concentration of active ingredients, while the viscosity is suitable for uniform mixing with the gel matrix. It will not affect the gel formation and drug loading due to excessive viscosity or thinness. The drug loading can carry sufficient repair components (such as the gum of Bletilla striata and various nutrients in honey) to ensure efficacy, while not destroying the physical structure of the gel network due to excessive drug loading, thus ensuring the stability of the gel's formation, adhesion and sustained-release properties.

[0028] Furthermore, the gel patch matrix also contains 0.5%-2% carbomer to adjust adhesion and sustained-release profile; and 1%-3% erythritol as a moisturizing factor.

[0029] In this embodiment of the invention, carbomer (0.5%-2%) has a dual fine-tuning effect: adjusting adhesion, it can fine-tune the adhesion of the gel to the skin, making it firmly attached and not easy to fall off, but not easy to leave residue or cause pain when removed; adjusting the sustained-release curve, as a hydrophilic gel material, it can interact with matrices such as poloxamer, further regulating the kinetics of water diffusion and drug release, making the release of active ingredients more stable and longer-lasting, and optimizing the "sustaining-release" effect; Erythritol (1%-3%) is a natural moisturizing factor that can effectively absorb and lock in moisture. In the closed environment created by the gel patch, it can continuously provide a moist healing environment for the wound. It is the core of the modern theory of moist healing and can significantly promote the migration of epithelial cells, accelerate healing, and reduce scab formation and scar formation.

[0030] Furthermore, in the soluble healing bath membrane, the mass ratio of polyvinyl alcohol to carboxymethyl chitosan is 3:1-5:1, the membrane thickness is 0.05-0.15mm, the particle size D90 of the core active ingredient ultrafine powder is ≤20μm, accounting for 20%-40% of the membrane weight, and the nano-silver-bioglass composite material accounts for 1%-5% of the membrane weight.

[0031] In this embodiment of the invention, polyvinyl alcohol (PVA) provides excellent film-forming properties, water solubility, and mechanical strength, and is the main framework of the membrane; carboxymethyl chitosan (CMCS) has inherent antibacterial properties, biocompatibility, and healing-promoting activity; at this ratio, the membrane maintains the rapid and complete water solubility of PVA (easy to use) and incorporates the biological functions of CMCS. At the same time, the addition of CMCS can also synergize with subsequent nano-silver and other materials to enhance the overall antibacterial and healing-promoting effect. The film thickness is 0.05-0.15mm. A thickness ≥0.05mm ensures that the film has sufficient mechanical strength, making it easy to handle, package, and store, and less prone to breakage. A thickness ≤0.15mm ensures that it can completely dissolve in warm water at 40-45℃ within a reasonable time (about 1-2 minutes), without affecting the user experience due to slow dissolution. This thickness also makes the film weight per unit area moderate and the active ingredient loading reasonable. Ultrafine powder technology (D90≤20μm) pulverizes six Chinese herbs to the micron level, greatly increasing the specific surface area of ​​the medicine. First, it can be quickly and evenly dispersed in the bath liquid when dissolved, avoiding clumping or precipitation. Second, the smaller particles are conducive to full contact with the skin during the medicinal bath, and even enhance absorption through hair follicles and other pathways, thereby improving the efficacy. The high drug loading capacity (20%-40%) ensures that each bath sheet contains a sufficient dose of compound Chinese medicine ingredients, enough to exert a systemic conditioning effect of "clearing heat and drying dampness, promoting blood circulation and detoxifying" during a 15-20 minute full-body medicinal bath, thus achieving the goal of in-depth health and wellness.

[0032] Furthermore, in the aforementioned nano-silver-bioglass composite material, nano-silver is loaded onto porous bioactive glass microspheres in elemental form, with a silver content of 0.5%-2% (w / w).

[0033] In this embodiment of the invention, the nano-silver-bioglass composite material (1%-5% content, silver content 0.5%-2%) loads nano-silver in elemental form onto porous bioactive glass microspheres, avoiding the aggregation of nano-silver particles and improving their dispersion stability and bioavailability. The bioactive glass can gradually release ions such as calcium, silicon, and phosphorus, which are crucial for tissue repair, in a bodily fluid environment. These ions can actively stimulate fibroblast proliferation and collagen synthesis, directly "instructing" the body to initiate the repair process. The nano-silver slowly and continuously releases silver ions from the porous carrier, providing a powerful and long-lasting broad-spectrum antibacterial effect, creating an ideal "sterile" or "low-bacterial" environment for the repair process. Through the composite material and low silver content design, while ensuring excellent antibacterial and healing effects, the amount of silver used and the potential risk of cytotoxicity are greatly reduced, resulting in higher safety.

[0034] Furthermore, the soluble healing bath film also contains 3%-8% by weight of triethyl citrate as a plasticizer, and 0.5%-1.5% of silica as an anti-caking agent and reinforcing agent.

[0035] In this embodiment of the invention, triethyl citrate (plasticizer, 3%-8%) makes the polymer membrane material (PVA / CMCS) more flexible and less brittle, improving the feel and processability of the membrane and ensuring that the membrane remains intact from production to user unpacking and use; silica (anti-caking agent / reinforcing agent, 0.5%-1.5%) effectively prevents the high proportion of traditional Chinese medicine ultrafine powder from absorbing moisture and clumping in the membrane, ensuring uniform component distribution; as a nanofiller, it can slightly improve the tensile strength and toughness of the membrane and may affect its dissolution kinetics, making its dissolution more controllable.

[0036] Furthermore, the application of a combination of antibacterial, full-cycle health-preserving traditional Chinese medicine preparations as described in any one of claims 1-7 in products for the prevention and care of intertrigo, diaper dermatitis, skin maceration, first- and second-degree burns, and skin barrier damage.

[0037] In some embodiments of the present invention, a method of using a combination of antibacterial and health-promoting traditional Chinese medicine compound preparation kit includes the following stages: Daily protection phase: Spray the quick-release protective spray on areas prone to sweating and friction until slightly damp, forming a hydrophobic and antibacterial film. Use 2-4 times daily. Intensive repair phase: After cleansing the skin, cut the slow-release repair gel patch according to the area of ​​skin damage and apply it to the erythema, maceration or minor damage. Each application lasts 4-8 hours and is repeated 1-2 times daily. Deep health and wellness stage: When bathing, place 1-2 of the soluble healing bath films mentioned above in bathwater at 40-45℃, stir until completely dissolved, and take a full-body medicinal bath for 15-20 minutes, 2-3 times a week.

[0038] Furthermore, immediately after the medicated bath described in the deep conditioning phase, the application of patches described in the intensive repair phase is performed to enhance the local repair effect.

[0039] Example 1 In one embodiment of the present invention, the quick-release protective spray comprises: Litsea cubeba essential oil nanoemulsion with a particle size of 120 nm; a compound alcohol extract (Polygonum cuspidatum: Senecio scandens: Aristolochia debilis: Glycyrrhiza uralensis = 4:3:1:1): with an ethanol concentration of 70%, the dry extract accounting for 22% of the total weight of the spray; and additives: menthol 0.3% and pentylene glycol 2%. Sustained-release repair gel patch: Base: 20% poloxamer F127, gelatin: sodium alginate = 1.5:1; Compound aqueous extract concentrate (Polygonum cuspidatum: Portulaca oleracea: dried ginger: Bletilla striata: honey freeze-dried powder = 4:2:1:2:1): relative density 1.15 (60℃), drug loading 18% (w / w); Additives: carbomer 1.2%, erythritol 2%; Soluble healing bath membrane: Substrate: PVA:CMCS=4:1, membrane thickness 0.10mm; Core medicinal ultrafine powder (six flavors): D90=15μm, accounting for 30% of membrane weight; Nano silver-bioglass composite material: accounting for 3% of membrane weight, silver content 1.2%; Additives: triethyl citrate 5%, silicon dioxide 1.0%.

[0040] Example 2 In one embodiment of the present invention, the instant-release protective spray comprises: nanoemulsion particles with a diameter of 200 nm, 15% dry alcohol extract, 0.1% menthol, and 1% pentylene glycol; Sustained-release repair gel patch: 18% poloxamer F127, gelatin: sodium alginate = 1:1, water extract drug loading 10%, carbomer 0.5%, erythritol 1%; Soluble healing bath film: PVA:CMCS=5:1, film thickness 0.15mm, ultrafine powder accounts for 20%, composite material accounts for 1%, silver content 0.5%, triethyl citrate 3%, silicon dioxide 0.5%.

[0041] Example 3 In one embodiment of the present invention, the instant-release protective spray comprises: nanoemulsion with a particle size of 50 nm, 30% dry extract of alcohol, 0.5% menthol, and 3% pentylene glycol; Sustained-release repair gel patch: 25% poloxamer F127, gelatin: sodium alginate = 2:1, water extract drug loading 25%, carbomer 2%, erythritol 3%; Soluble healing bath film: PVA:CMCS=3:1, film thickness 0.05mm, ultrafine powder accounts for 40%, composite material accounts for 5%, silver content 2%, triethyl citrate 8%, silica 1.5%.

[0042] Comparative Example 1 The modern formulation technology of this invention is not used; only the traditional form of the same Chinese herbal compound is used. Protective agent: a simple ethanol solution of Litsea cubeba essential oil and alcohol extract (non-nanoemulsion); Repairing agent: Contains no thermosensitive gel, only a mixture of concentrated water extract and ordinary carboxymethyl cellulose gel; Health and wellness product: It is made by mixing ordinary fine powder of six Chinese herbs (D90>100μm) with bath salts, and does not contain nano silver-bioglass composite material or soluble film.

[0043] Comparative Example 2 Using only the "slow-release repair gel patch" (same formula as in Example 1) from the kit of this invention, without using the "quick-release protective spray" and "soluble healing bath film", simulates a single-product intervention mode.

[0044] Experimental results The following are the key performance test results for the above embodiments and comparative designs:

[0045] Brief description of experimental methods: In vitro antibacterial activity: The inhibition zone was measured using the agar diffusion method, and the minimum inhibitory concentration (MIC) was determined using the broth dilution method; Release and transdermal activity: The release of the index components was determined by HPLC using a Franz diffusion cell to simulate the skin pH environment; Transdermal activity was determined using an isolated porcine skin model; Cell viability: The effect of the sample on the survival rate of L929 fibroblasts was determined by the CCK-8 assay; Animal model: A rat back second-degree burn model was established, and drugs were administered to groups (the example group was treated according to the methods of claims 9-10), and the healing time was observed and recorded regularly, and histopathological scoring and measurement were performed; Full-cycle simulation: An intertrigo model induced by artificial sweat and friction was established, and groups were treated according to different protocols, and the incidence of skin erythema and lesions was statistically analyzed.

[0046] Experimental conclusion: The formulation kit of this invention has excellent and synergistic antibacterial and repair effects: the three examples are significantly better than Comparative Example 1 in key indicators such as in vitro antibacterial, sustained-release transdermal, cell safety and animal model repair; this proves that the application of modern formulation technologies such as nanoemulsion, thermosensitive dual-network gel, and nano-silver-bioglass composite material can greatly improve the bioavailability, duration of action and therapeutic targeting of traditional Chinese medicine components. The "full-cycle combined use" model has significant advantages over the "single dosage form": Comparative Example 2 (using only the patch) was inferior to Example 1 in terms of healing time, inflammation control, and final epidermal regeneration quality in the animal model; in the prevention model, the incidence of problems with the single dosage form was also much higher than that of the combined use group, which verified the scientific validity and necessity of the three-stage combined use strategy of "rapid-release protection - sustained-release repair - deep health care", achieving a synergistic effect of "1+1+1>3", which can more effectively block the occurrence of problems, accelerate damage repair, and promote the complete reconstruction of the skin barrier; The parameter range of this invention is designed to be reasonable and effective: Examples 1-3 are all within the scope of protection of the claims, and all experimental results are excellent. Example 3 shows the strongest performance in antibacterial and healing promotion, and Example 2 also shows clear effectiveness, proving that the scope of the claims can be used to prepare products with reliable performance. The differences between different examples also provide room for formula adjustment for different severity levels or skin types.

[0047] In summary, the "Antibacterial Full-Cycle Health-Preserving Traditional Chinese Medicine Compound Preparation Kit" and its usage method provided by this invention, through innovative combination of dosage form technology and spatiotemporal synergistic effects of active ingredients, have been experimentally proven to significantly improve the prevention, repair speed, and healing quality of skin barrier problems such as intertrigo and minor burns. Its comprehensive performance is significantly superior to traditional dosage forms or single-product intervention models, possessing outstanding clinical application value and market potential. The embodiments described above are some, but not all, embodiments of this invention. The detailed description of the embodiments of this invention is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without inventive effort are within the scope of protection of this invention.

Claims

1. A combination of traditional Chinese medicine preparations for antibacterial and health-promoting treatment throughout the entire life cycle, characterized in that, A kit containing the following three individual formulations: The quick-release protective spray uses Litsea cubeba essential oil nanoemulsion as solvent and is loaded with a compound alcohol extract extracted from Polygonum cuspidatum, Senecio scandens, Clematis armandii, and Glycyrrhiza uralensis in a weight ratio of 4:3:1:

1. The sustained-release repair gel patch uses thermosensitive poloxamer F127 and gelatin-sodium oxidized alginate double network hydrogel as the matrix, and encapsulates a compound water extract concentrate obtained by extracting and concentrating freeze-dried powders of Polygonum cuspidatum, Portulaca oleracea, dried ginger, Bletilla striata and honey in a weight ratio of 4:2:1:2:

1. The soluble healing bath film is a biodegradable film made of polyvinyl alcohol and carboxymethyl chitosan by casting. It contains dispersed core medicinal component ultrafine powder and nano silver-bioglass composite material. The core medicinal component ultrafine powder includes Polygonum cuspidatum, Senecio scandens, Portulaca oleracea, dried ginger, Coptis chinensis, and Euphorbia humifusa.

2. The antibacterial, full-cycle health-preserving traditional Chinese medicine compound preparation kit according to claim 1, characterized in that, In the instant-release protective spray, the particle size of the Litsea cubeba essential oil nanoemulsion is 50-200nm, the ethanol extraction concentration of the compound alcohol extract is 60%-80%, the dry extract accounts for 15%-30% of the total weight of the spray, and it contains 0.1%-0.5% menthol and 1%-3% pentanediol.

3. The antibacterial, full-cycle health-preserving traditional Chinese medicine compound preparation kit according to claim 1, characterized in that, In the sustained-release repair gel patch, the concentration of thermosensitive poloxamer F127 is 18%-25%, the mass ratio of gelatin to sodium alginate is 2:1-1:1, the relative density of the compound aqueous extract concentrate is 1.10-1.20 (60℃), and its drug loading in the gel matrix is ​​10%-25% (w / w).

4. The antibacterial, full-cycle health-preserving traditional Chinese medicine compound preparation kit according to claim 1, characterized in that, The gel patch matrix also contains 0.5%-2% carbomer to adjust adhesion and sustained-release profile; and 1%-3% erythritol as a moisturizing factor.

5. The antibacterial, full-cycle health-preserving traditional Chinese medicine compound preparation kit according to claim 1, characterized in that, In the soluble healing bath membrane, the mass ratio of polyvinyl alcohol to carboxymethyl chitosan is 3:1-5:1, the membrane thickness is 0.05-0.15mm, the particle size D90 of the core active ingredient ultrafine powder is ≤20μm, accounting for 20%-40% of the membrane weight, and the nano silver-bioglass composite material accounts for 1%-5% of the membrane weight.

6. The antibacterial, full-cycle health-preserving traditional Chinese medicine compound preparation kit according to claim 5, characterized in that, In the aforementioned nano-silver-bioglass composite material, nano-silver is loaded onto porous bioactive glass microspheres in elemental form, with a silver content of 0.5%-2% (w / w).

7. The antibacterial, full-cycle health-preserving traditional Chinese medicine compound preparation kit according to claim 6, characterized in that, The soluble healing bath film also contains 3%-8% by weight of triethyl citrate as a plasticizer and 0.5%-1.5% of silica as an anti-caking agent and reinforcing agent.

8. The application of a combination of antibacterial, full-cycle health-preserving traditional Chinese medicine preparations as described in any one of claims 1-7 in the prevention and care of intertrigo, diaper dermatitis, skin maceration, first- and second-degree burns, and skin barrier damage.

9. A method of using a combination of antibacterial, full-cycle health-preserving traditional Chinese medicine preparations as described in any one of claims 1-7, characterized in that, Includes the following stages: Daily protection phase: Spray the quick-release protective spray on areas prone to sweating and friction until slightly damp, forming a hydrophobic and antibacterial film. Use 2-4 times daily. Intensive repair phase: After cleansing the skin, cut the slow-release repair gel patch according to the area of ​​skin damage and apply it to the erythema, maceration or minor damage. Each application lasts 4-8 hours and is repeated 1-2 times daily. Deep health and wellness stage: When bathing, place 1-2 of the soluble healing bath films mentioned above in bathwater at 40-45℃, stir until completely dissolved, and take a full-body medicinal bath for 15-20 minutes, 2-3 times a week.

10. The method of using the antibacterial, full-cycle health-preserving traditional Chinese medicine compound preparation kit according to claim 9, characterized in that, Immediately after the medicated bath described in the deep conditioning phase, apply the patch described in the intensive repair phase to enhance the local repair effect.

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