Bacteriostatic dampness-eliminating anti-inflammatory health-care Yao bath compound nano medicine powder and preparation method thereof

Abstract

This invention relates to the field of pharmaceutical technology, specifically to a compound nanopowder for antibacterial, dampness-removing, anti-inflammatory, and health-promoting Yao bath, and its preparation method. The compound nanopowder comprises: the core active ingredient, prepared by ultra-fine pulverization of the following raw materials in parts by weight: 40 parts Polygonum cuspidatum, 30 parts Senecio scandens, 20 parts Portulaca oleracea, 10 parts dried ginger, 5 parts Coptis chinensis, and 5 parts Euphorbia humifusa; the surface-modifying component is one or more of pullulan, chitosan quaternary ammonium salt, and γ-cyclodextrin, and the amount of the surface-modifying component is 1%-10% of the weight of the core active ingredient powder. This application addresses the shortcomings of existing technologies in terms of poor stability and permeability by abandoning the simple "pulverization-mixing" process, providing a compound nanopowder for antibacterial, dampness-removing, anti-inflammatory, and health-promoting Yao bath, and its preparation method, aiming to improve the stability and transdermal efficiency of the components.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, and more specifically, to a compound nanopowder for antibacterial, dampness-removing, anti-inflammatory, and health-promoting Yao bath, and its preparation method. Background Technology

[0002] Existing Yao bath or traditional Chinese medicine bath powders are usually made by directly mixing various Chinese medicinal materials after sun drying and coarse grinding. In order to improve solubility and skin feel, some existing technologies use ordinary ultra-fine grinding processes to grind the medicinal materials to several hundred mesh. In addition, nanotechnology has been applied in the fields of high-end cosmetics or drug delivery, such as using ball milling or high pressure homogenization to prepare nano suspensions, or using liposomes or polymer nanoparticles to encapsulate single active ingredients.

[0003] Existing technologies suffer from low utilization rates of active ingredients. Coarsely ground or ordinary ultrafinely ground medicinal powders do not adequately break down cell walls, resulting in slow and incomplete dissolution of active ingredients in the bath liquid, leading to low effective utilization. Stability and permeability are also poor. Simple physical powder mixtures often result in hydrophobic components floating, making the system unstable. Furthermore, the relatively large particle size makes it difficult to penetrate the skin's stratum corneum, limiting transdermal absorption and limiting the effect to the surface. Ingredients are prone to inactivation. Conventional grinding processes generate high heat, easily leading to the oxidation and degradation of heat-sensitive volatile oils and polyphenols in the medicinal materials, affecting the antibacterial and anti-inflammatory activity of the final product. Functions are limited; existing Yao bath powders primarily focus on single functions such as dehumidification or antibacterial action, lacking comprehensive conditioning capabilities for complex skin problems (such as damp-heat itching accompanied by minor damage). The processes are crude and reproducible. Existing preparation methods lack precise control over key process parameters (such as temperature and grinding energy), resulting in significant differences in particle size distribution and efficacy between different batches of products.

[0004] This application addresses the shortcomings of existing technologies in terms of stability and permeability by abandoning the simple "pulverization-mixing" process and providing a compound nanopowder for antibacterial, dampness-removing, anti-inflammatory, and health-promoting Yao bath, as well as its preparation method, aiming to improve the stability of the ingredients and transdermal efficiency. Summary of the Invention

[0005] The purpose of this invention is to provide a compound nano-powder for antibacterial, dampness-removing, anti-inflammatory, and health-preserving Yao bath, and its preparation method, which solves the defects of poor stability and permeability in the existing technology.

[0006] On the one hand, a compound nano-powder for antibacterial, dampness-removing, anti-inflammatory, and health-preserving Yao bath is characterized by being made of core active ingredients and surface-modifying ingredients; The core active ingredient is made from the following raw materials by weight through ultra-fine grinding: 40 parts Polygonum cuspidatum, 30 parts Senecio scandens, 20 parts Portulaca oleracea, 10 parts dried ginger, 5 parts Coptis chinensis, and 5 parts Euphorbia humifusa. The surface-modifying component is one or more of pullulan, chitosan quaternary ammonium salt, and γ-cyclodextrin, and the amount of the surface-modifying component is 1%-10% of the weight of the core active ingredient powder.

[0007] Furthermore, the core active ingredient powder has a particle size D90≤5μm, and after being treated with surface-modified components through fluidized bed coating or molecular self-assembly technology, it forms nanospheres with an average particle size of 100nm-1μm.

[0008] Furthermore, the absolute value of the zeta potential of the nanospheres is greater than 30mV, and they can be stably suspended for more than 24 hours in an aqueous dispersion system with pH 5.5-8.0.

[0009] Furthermore, among the raw materials of the core active ingredient, Polygonum cuspidatum is the rhizome of a three-year-old Polygonum cuspidatum from the understory of Jiangyin slopes, Senecio scandens is the above-ground part of wild Senecio scandens from Leigong Mountain in southeastern Guizhou, and Coptis chinensis is the whole flowering herb harvested in autumn.

[0010] Furthermore, the core active ingredient also includes 2-5 parts by weight of extracts of *Rhizoma Cimicifugae* or *Caulis Paederia scandens*, wherein the extracts are spray-dried powders obtained after water extraction and alcohol precipitation.

[0011] Furthermore, the surface-modifying component also includes a complex of pullulan and ε-polylysine in a weight ratio of 1:0.5-2.

[0012] On the other hand, a method for preparing a compound nano-powder for antibacterial, dampness-removing, anti-inflammatory, and health-promoting Yao bath includes the following steps: Step 1: Weigh the raw medicinal materials of the core active ingredient according to the proportion, and freeze-dry them separately at low temperature of -40℃ to -20℃ to make the moisture content of the medicinal materials less than 5%. After mixing, pulverize them using low temperature supersonic airflow pulverization technology to obtain ultrafine powder of the core active ingredient. Step 2: Dissolve the surface-modifying component in a 40%-60% ethanol-water mixed solvent to prepare a coating solution with a mass concentration of 2%-8%. Step 3: In a high-voltage electrostatic spraying device, the core active pharmaceutical ingredient ultrafine powder is fluidized in a fluidized bed under the protection of inert gas. At the same time, a coating solution with a mass concentration of 2%-8% is atomized and sprayed in at a rate of 0.5-2.0 mL / min, so that the surface modification component crystallizes and coats the powder particles in situ to form nanospheres. The electrostatic spraying voltage is 15-25kV, and the distance between the nozzle and the fluidized powder bed is 10-20cm. Step 4: Collect the product nanospheres, vacuum dry them at 50-60℃ for 2-4 hours, then sterilize them with low-temperature plasma, and package them in aluminum-plastic composite film bags, and fill them with nitrogen for protection.

[0013] Furthermore, in step 1, the operating temperature of the low-temperature supersonic airflow pulverizer is -10℃ to 10℃, the pulverizing pressure is 0.8-1.2MPa, and the material is pulverized in 3-5 cycles.

[0014] Furthermore, in step 3, the inert gas is nitrogen or argon, and the fluidizing gas temperature is 25-35℃.

[0015] Furthermore, in step 4, the parameters for the low-temperature plasma sterilization are: power 300-500W, processing time 5-15 minutes, and working gas is a mixture of argon and oxygen.

[0016] Compared with the prior art, the embodiments of the present invention have at least the following advantages or beneficial effects: 1. Based on the classic antibacterial and dampness-removing formula of "Polygonum cuspidatum - Senecio scandens - Portulaca oleracea - dried ginger," this formula innovatively introduces Coptis chinensis (for clearing heat and detoxifying, promoting blood circulation and relieving pain) and Euphorbia humifusa (for clearing heat and promoting diuresis) as adjuvant herbs, enhancing the formula's anti-inflammatory, blood-activating, and deep-seated damp-heat-clearing effects. Optional additions such as Ramulus arvense or Paederia scandens further strengthen the functions of dispelling wind and dampness, and promoting digestion and eliminating food stagnation, allowing this compound to not only act on the skin surface but also focus on regulating internal dampness and stagnation, achieving a comprehensive health-preserving effect that addresses both the symptoms and the root cause.

[0017] 2. By pulverizing the core active pharmaceutical ingredients to a D90 ≤ 5 μm and ultimately constructing nanospheres of 100 nm-1 μm, ultrafine drug particle size was achieved. This significantly increases the contact area with water, allowing poorly soluble active ingredients (such as polygalactoside, resveratrol, and gingerol) to dissolve and be released rapidly and fully. More importantly, nanoscale particles can more easily penetrate the gaps in the stratum corneum of the skin, significantly improving bioavailability and onset of action, resulting in a qualitative leap in the "external treatment" effect of traditional Yao bath.

[0018] 3. By coating with surface modifiers such as pullulan, chitosan quaternary ammonium salt, and γ-cyclobutin, the resulting nanospheres possess extremely high absolute Zeta potential values ​​(>30mV). Under electrostatic repulsion, they can remain stably suspended in water for extended periods (>24 hours), solving the problems of easy sedimentation and uneven distribution of active ingredients in traditional bath powders, ensuring accurate dosage for each use. The application of low-temperature vacuum freeze-drying and low-temperature supersonic airflow pulverization technologies maximizes the preservation of the activity of volatile components (such as ginger volatile oil) and heat-sensitive polyphenols and flavonoids in the medicinal materials, avoiding efficacy loss caused by traditional drying and high-temperature pulverization. The selected surface modifiers (such as chitosan quaternary ammonium salt and ε-polylysine) themselves possess antibacterial and bioadhesive properties. After contact with the skin, the microsphere structure can achieve sustained release through material properties or concentration gradients, prolonging the duration of action. The nanoscale size also lays the technological foundation for future skin-targeted delivery.

[0019] 4. From freeze-drying and low-temperature airflow pulverization to low-temperature plasma sterilization, the entire preparation process is carried out under mild conditions, systematically ensuring the stability and high activity of the product's chemical quality, which is unparalleled by traditional processes. The use of high-voltage electrostatic spray coating technology allows for precise control of the coating layer's thickness and uniformity, enabling controllable production of nanospheres in terms of particle size, morphology, and surface properties, ensuring high batch-to-batch consistency and product quality reliability. Low-temperature plasma sterilization technology achieves efficient sterilization without generating high temperatures or leaving chemical residues, conforming to modern green processing concepts and ensuring product safety. 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 compound nano-powder for antibacterial, dampness-removing, anti-inflammatory, and health-promoting Yao bath, which is made of core active ingredients and surface-modifying ingredients; The core active ingredient is made from the following raw materials by weight through ultra-fine grinding: 40 parts Polygonum cuspidatum, 30 parts Senecio scandens, 20 parts Portulaca oleracea, 10 parts dried ginger, 5 parts Coptis chinensis, and 5 parts Euphorbia humifusa. The surface-modifying component is one or more of pullulan, chitosan quaternary ammonium salt, and γ-cyclodextrin, and the amount of the surface-modifying component is 1%-10% of the weight of the core active ingredient powder.

[0023] In this embodiment of the invention, the principal herb Polygonum cuspidatum (containing emodin and resveratrol) and the assistant herb Senecio scandens (containing alkaloids) work synergistically to significantly inhibit common skin pathogens such as Staphylococcus aureus and Escherichia coli. The adjuvant herbs Coptis chinensis (containing coptisine) and Euphorbia humifusa further enhance their anti-inflammatory, heat-clearing, and blood-cooling effects, effectively relieving inflammatory reactions such as skin redness, swelling, and pain. Purslane promotes diuresis, clears heat, and detoxifies, while dried ginger warms the middle jiao, dispels cold, and promotes blood circulation. The combination of these two herbs, one clearing and one warming, effectively resolves both dampness and heat. It removes dampness and turbidity from the skin surface, and promotes the transportation and expulsion of deep dampness through its warming and invigorating effects, improving skin itching and erosion caused by dampness retention; the whole formula eliminates pathogens (antibacterial, dampness-removing, and anti-inflammatory) while also strengthening the body's resistance; the blood-activating effects of herbs such as Euphorbia humifusa help improve local microcirculation and provide nutrition for skin repair; the nano-sized ingredients are more easily absorbed, comprehensively regulating the skin's microecology, enhancing the skin's own barrier function, and achieving a "health and wellness" effect from treatment to maintenance; The core active ingredient is processed into ultrafine powder with a D90 ≤ 5μm and ultimately forms nanospheres of 100nm-1μm, resulting in an exponential increase in specific surface area. This allows for thorough disruption of the cell walls of the medicinal materials, significantly improving the dissolution rate and extent of poorly soluble active ingredients in water, thus solving the problem of traditional bath powders failing to deliver medicinal effects. The nanoscale particles can more effectively penetrate the microscopic gaps in the stratum corneum, allowing the active ingredients to reach deeper target areas of the skin (such as hair follicles, sebaceous glands, and the superficial dermis), thereby exerting a localized high-concentration therapeutic effect, resulting in faster onset and longer-lasting effects. Through coating with surface modifiers such as pullulan, the formed nanospheres exhibit high surface area... The charge (absolute value of Zeta potential > 30mV) allows the nanospheres to remain stably suspended in the bath liquid for a long time under the action of electrostatic repulsion, preventing the active ingredients from rapidly settling to the bottom. This ensures that the concentration of the medicine is uniform during each bath, and the dosage of medicine that comes into contact with the human body is stable and reliable. Surface-modifying materials such as chitosan quaternary ammonium salt have antibacterial and bioadhesive properties, which can form a protective film on the skin surface and prolong the drug's action time. The inclusion effect of γ-cyclodextrin can protect and solubilize certain unstable components. The introduction of ε-polylysine (if selected) further enhances the broad-spectrum antibacterial effect. These materials make the nanospheres not only carriers, but also functional units for active delivery and enhanced efficacy. Nanoparticles disperse and dissolve rapidly in water, resulting in a clear or uniformly milky bath liquid without the rough, granular feel and residue of traditional bath powders, providing a superior user experience. The low-temperature process preserves the natural properties of the medicinal materials, avoiding potential irritants from high-temperature processing. Due to their tiny size and surface modification, nanospheres have better skin compatibility, reducing discomfort from physical friction. From low-temperature drying and pulverization of the medicinal materials to aseptic packaging of the finished product, the entire process aims to protect the active ingredients. The final product maximizes the release and delivery of the effective substances in the compound formula, ensuring that the efficacy of each medicinal ingredient is fully realized.

[0024] Furthermore, the core active ingredient powder has a particle size D90≤5μm, and after being treated with surface-modified components through fluidized bed coating or molecular self-assembly technology, it forms nanospheres with an average particle size of 100nm-1μm.

[0025] In this embodiment of the invention, the particle size range of the core powder with D90≤5μm ensures that the cell walls of the medicinal materials are almost completely broken, and the effective components inside the cells (such as glutinin, resveratrol, alkaloids, etc.) are exposed to the maximum extent, which lays the physical basis for subsequent efficient dissolution and nano-processing, and solves the core problem of slow and incomplete dissolution of components caused by traditional coarse grinding or ordinary ultrafine grinding (such as D90>20μm). The active ingredients are constructed within nanospheres with an average particle size of 100nm-1μm. This nanoscale allows the active ingredients to pass through the intercellular spaces and appendages of the stratum corneum, significantly improving the transdermal penetration rate and amount of the drug, enabling the drug to reach deeper target sites. The extremely high specific surface area causes the contact area between the microspheres and water to increase exponentially, allowing the active ingredients to dissolve and be released instantly upon contact with water, achieving "instant dissolution and immediate effect." The "fluidized bed coating or molecular self-assembly" technology ensures that the surface-modified components can be uniformly and controllably coated on the surface of the core drug particles, forming structurally stable and uniformly sized nanospheres, guaranteeing the reproducibility of product quality and industrial feasibility.

[0026] Furthermore, the absolute value of the zeta potential of the nanospheres is greater than 30mV, and they can be stably suspended for more than 24 hours in an aqueous dispersion system with pH 5.5-8.0.

[0027] In this embodiment of the invention, the absolute value of the Zeta potential is >30mV: this is a key indicator for measuring the stability of the colloidal dispersion system; a high Zeta potential means that the surface of the nanospheres carries a strong like charge, generating a strong electrostatic repulsion between particles, thereby effectively resisting collision aggregation and sedimentation caused by Brownian motion; stable suspension at pH 5.5-8.0 for >24 hours ensures uniform therapeutic effect. During the effective suspension period of up to 24 hours, the drug concentration in the bath solution remains uniform, and the user can come into contact with the effective concentration of medicine throughout the entire process from entering to leaving the bath, solving the drawbacks of traditional bath powders that quickly sink to the bottom and have a clear upper concentration and a concentrated lower concentration of medicine; the stable pH range covers common water qualities from weakly acidic to weakly alkaline, indicating that the product can maintain a good dispersion state in different water qualities, with wide applicability and reliable performance.

[0028] Furthermore, among the raw materials of the core active ingredient, Polygonum cuspidatum is the rhizome of a three-year-old Polygonum cuspidatum from the understory of Jiangyin slopes, Senecio scandens is the above-ground part of wild Senecio scandens from Leigong Mountain in southeastern Guizhou, and Coptis chinensis is the whole flowering herb harvested in autumn.

[0029] In this embodiment of the invention, the specific climate, soil, and ecological conditions of the authentic producing areas usually mean that the content of characteristic active ingredients in the medicinal materials is higher and the composition is better, thus ensuring the basic medicinal power of the core active ingredients from the source. The growth period and harvesting part are based on traditional experience and modern research on the best harvesting period of Chinese medicinal materials. For example, the alkaloid active ingredients of Coptis chinensis with flowers harvested in autumn may accumulate the most, ensuring that the raw materials used are at the peak of the active ingredients, providing the best material basis for the excellent efficacy of the final product.

[0030] Furthermore, the core active ingredient also includes 2-5 parts by weight of extracts of *Rhizoma Cimicifugae* or *Caulis Paederia scandens*, wherein the extracts are spray-dried powders obtained after water extraction and alcohol precipitation.

[0031] In this embodiment of the invention, the addition of *Rhizoma Cynanchi* or *Caulis Padmasana* extract, based on the strong antibacterial, dampness-removing, and anti-inflammatory properties of the core formula (*Polygonum cuspidatum*, *Senecio scandens*, *Portulaca oleracea*, dried ginger, *Coptis chinensis*, and *Euphorbia humifusa*), enhances the formula's ability to relieve joint and skin discomfort caused by rheumatic obstruction. *Rhizoma Cynanchi* excels at digestion, wind-dispelling, and dampness-removing properties, and can assist in regulating spleen and stomach dampness, thus helping to remove dampness from the "internal environment" level, embodying the concept of "treating both internal and external factors" in health maintenance. The refining process of the spray-dried powder after water extraction and alcohol precipitation removes most impurities (such as starch and tannins), resulting in a purer active ingredient extract that is more compatible with the nanosphere system, ensuring the stability of the product system and the reliability of the added efficacy.

[0032] Furthermore, the surface-modifying component also includes a complex of pullulan and ε-polylysine in a weight ratio of 1:0.5-2.

[0033] In this embodiment of the invention, ε-polylysine is a natural, broad-spectrum, and highly effective antimicrobial peptide. When combined with pullulan, it forms an "active antimicrobial layer" on the surface of the nanospheres. When the microspheres are dispersed in bath liquid or come into contact with the skin, ε-polylysine can be released first, achieving rapid and potent antibacterial activation, and producing a synergistic or additive antibacterial effect with the core traditional Chinese medicine ingredients. ε-polylysine is positively charged and can electrostatically adsorb with the negatively charged stratum corneum of the skin and microbial cell membranes, thereby prolonging the residence time of the nanospheres on the skin surface and achieving a more lasting therapeutic effect. This makes the nanospheres themselves a multifunctional intelligent carrier integrating "targeted delivery (nanoscale)," "physical stability (high zeta potential)," "active antibacterial (ε-polylysine)," and "biocompatibility (pullulan)," resulting in a dual improvement in technological content and product efficacy. In some embodiments of the present invention, a method for preparing a compound nanopowder for antibacterial, dampness-removing, anti-inflammatory, and health-promoting Yao bath includes the following steps: Step 1: Weigh the raw medicinal materials of the core active ingredient according to the proportion, and freeze-dry them separately at low temperature of -40℃ to -20℃ to make the moisture content of the medicinal materials less than 5%. After mixing, pulverize them using low temperature supersonic airflow pulverization technology to obtain ultrafine powder of the core active ingredient. Protecting heat-sensitive and easily oxidized active ingredients; at deep low temperatures, the moisture in the medicinal materials directly sublimates, avoiding the degradation and loss of bioactivity of heat-sensitive components (such as resveratrol in Polygonum cuspidatum and volatile oil in dried ginger) caused by conventional hot air drying, while preserving the original morphology and porous structure of the medicinal materials to the maximum extent, laying the foundation for subsequent efficient pulverization; low moisture content is the key to ensuring pulverization efficiency and preventing material adhesion and blockage during the pulverization process; Step 2: Dissolve the surface-modifying components in a 40%-60% ethanol-water mixed solvent to prepare a coating solution with a mass concentration of 2%-8%. The ethanol-water mixed solvent can effectively dissolve surface-modifying components such as pullulan and chitosan quaternary ammonium salt. The concentration range of 2%-8% is crucial: if the concentration is too low, the coating layer will be too thin or incomplete, failing to provide sufficient spatial stability and functionality; if the concentration is too high, the solution viscosity will be too high, affecting the subsequent atomization uniformity and coating effect. It is essential to ensure that a solution with excellent flowability and atomability is obtained, and that an effective coating layer can be formed. Step 3: In a high-voltage electrostatic spraying device, the core active pharmaceutical ingredient ultrafine powder is fluidized in a fluidized bed under the protection of inert gas. At the same time, a coating solution with a mass concentration of 2%-8% is atomized and sprayed in at a rate of 0.5-2.0 mL / min, so that the surface modification component crystallizes and coats the powder particles in situ to form nanospheres. The electrostatic spraying voltage is 15-25kV, and the distance between the nozzle and the fluidized powder bed is 10-20cm. Under the action of a high-voltage electrostatic field, the coating solution is torn into uniformly sized microdroplets with the same charge, which lays the foundation for the formation of nanospheres with narrow particle size distribution. In-situ crystallization coating: the charged droplets are precisely guided to the fluidized core drug powder. During the flight and collision process, the solvent evaporates rapidly, and the surface-modified components crystallize and deposit in situ on the surface of the powder particles, forming a uniform and dense coating layer. The precise control of the spray distance and flow rate ensures the matching of the degree of solvent evaporation with the coating film formation process, which is the key process parameter for forming nanospheres with complete structure and particle size of 100nm-1μm. Step 4: Collect the product nanospheres, vacuum dry them at 50-60℃ for 2-4 hours, then sterilize them with low-temperature plasma, and package them in aluminum-plastic composite film bags and fill them with nitrogen for protection. Vacuum drying at 50-60℃ for 2-4 hours aims to thoroughly remove trace amounts of solvent and moisture introduced during the coating process, solidifying and shaping the nanosphere structure while preventing the coating material from melting or the active ingredients from changing due to high temperatures. The aluminum-plastic composite film packaging, with nitrogen purging, is the final barrier to product stability. The light-proof aluminum-plastic composite film blocks light and oxygen, while the inert nitrogen purging removes oxygen and moisture from the packaging, creating a stable microenvironment that effectively prevents the nanospheres from oxidizing, absorbing moisture, agglomerating, and growing microorganisms during storage, ensuring stable product performance throughout its shelf life.

[0034] In some embodiments of the present invention, in step 1, the operating temperature of the low-temperature supersonic airflow pulverization is -10℃ to 10℃, the pulverization pressure is 0.8-1.2MPa, and the material undergoes 3-5 cycles of pulverization. Continuously controlling the low temperature during the pulverization process effectively counteracts the heat generated by the impact of high-speed airflow and particle collision, preventing "thermal damage" and ensuring that the active substances retained after freeze-drying are not destroyed in the pulverization process. The high kinetic energy generated by the supersonic airflow, combined with multiple cycles of pulverization, enables efficient and uniform cell wall disruption of medicinal materials, ensuring that the core active ingredient powder stably meets the stringent requirement of D90≤5μm, providing "core raw materials" with qualified size and intact activity for the construction of nanospheres. In some embodiments of the present invention, in step 3, the inert gas is nitrogen or argon, and the fluidization gas temperature is 25-35°C. Operating under an inert atmosphere can completely prevent the active ingredients from being oxidized during processing, which is a guarantee of high-quality manufacturing. The appropriate fluidization temperature ensures a good fluidization state of the powder, while avoiding excessive temperature from causing the coating material to deform or the active ingredients to be damaged.

[0035] In some embodiments of the present invention, in step 4, the parameters of the low-temperature plasma sterilization are: power 300-500W, processing time 5-15 minutes, and working gas is a mixture of argon and oxygen; achieving "green, cold sterilization". Compared with traditional high-temperature steam sterilization (which destroys heat-sensitive components), irradiation sterilization (which may cause material denaturation) or chemical sterilization (which poses a risk of residue), low-temperature plasma, at near room temperature, destroys the genetic material and cell structure of microorganisms through the generated active particles (such as free radicals and ultraviolet photons), achieving efficient and thorough sterilization without producing thermal effects or introducing chemical residues, making it perfectly suited for high-end nano-products that are sensitive to heat and chemicals.

[0036] Example 1 In one embodiment of the present invention, 40 kg of three-year-old Polygonum cuspidatum rhizome from Congjiang, 30 kg of the above-ground parts of wild Senecio scandens from Leigong Mountain, 20 kg of Portulaca oleracea, 10 kg of dried ginger, 5 kg of Coptis chinensis with autumn flowers, and 5 kg of Euphorbia humifusa were weighed by weight; each medicinal material was placed in a vacuum freeze-drying environment at -35°C until the moisture content was <5%; after mixing, the mixture was pulverized four times using a low-temperature supersonic airflow pulverizer at -5°C and 1.0 MPa pressure to obtain ultrafine powder of the core active ingredient with D90=4.2μm; Weigh 1.0 kg pullulan polysaccharide and 0.5 kg chitosan quaternary ammonium salt, dissolve them in 50% ethanol-water mixed solvent, and make up to 25 kg to obtain a coating solution with a mass concentration of 6%. The above ultrafine powder was added to a fluidized bed and circulated with nitrogen gas at 30°C. Under an electrostatic voltage of 20kV, the coating solution was atomized and sprayed at a rate of 1.0 mL / min (spray distance 15cm) to coat the surface modifier on the powder surface. The resulting wet microspheres were vacuum dried at 55°C for 3 hours. The dried microspheres were placed in a low-temperature plasma sterilization device and treated for 10 minutes at 400W power under an argon-oxygen mixture. After sterilization, the product was packaged into aluminum-plastic bags, filled with nitrogen and sealed to obtain nano-microsphere bath powder A.

[0037] Example 2 In one embodiment of the present invention, 40 kg of Polygonum cuspidatum, 30 kg of Senecio scandens, 20 kg of Portulaca oleracea, 10 kg of dried ginger, 5 kg of Coptis chinensis, 5 kg of Euphorbia humifusa, and 3 kg of Boehmeria nivea extract (water-extracted, alcohol-precipitated, spray-dried powder) were weighed; and the powder was pulverized three times at 2°C and 1.1 MPa as in Example 1 to obtain core powder with D90=4.8μm. Weigh 0.8 kg pullulan and 1.2 kg ε-polylysine, dissolve them in a 45% ethanol-water mixed solvent, and bring the volume to 20 kg to obtain a coating solution with a mass concentration of 10%. Under argon protection at 25°C, the coating solution was atomized and sprayed into the fluidized powder at a rate of 1.5 mL / min (spray distance 12 cm) with a voltage of 18 kV; subsequent drying, sterilization and packaging were the same as in Example 1, to obtain nanosphere bath powder B.

[0038] Example 3 In one embodiment of the present invention, 40 kg of Polygonum cuspidatum, 30 kg of Senecio scandens, 20 kg of Portulaca oleracea, 10 kg of dried ginger, 5 kg of Coptis chinensis, 5 kg of Euphorbia humifusa, and 5 kg of Paederia scandens extract were weighed; and the mixture was pulverized 5 times at 8°C and 0.9 MPa using the same method as in Example 1 to obtain core powder with D90=3.9μm. Weigh 1.2 kg of γ-cyclodextrin, dissolve it in a 55% ethanol-water mixed solvent, and make up to 30 kg to obtain a coating solution with a mass concentration of 4%. Under nitrogen protection at 28℃, the coating solution was atomized and sprayed at a rate of 0.8 mL / min (spray distance 18 cm) with a voltage of 22 kV. The wet microspheres were vacuum dried at 50℃ for 4 hours and plasma sterilized at 350 W power for 12 minutes. After packaging, the nano-microsphere Yao Bath Powder C was obtained.

[0039] Comparative Example 1 (Traditional Process) Weigh out the same type and proportion of medicinal materials as in Example 1 (not from authentic regions, but commercially available); dry them with hot air at 80°C to a moisture content of about 10%, mix them, and then pulverize them with a regular mechanical pulverizer and pass them through a 200-mesh sieve (about 75μm); sterilize the powder with Co-60 irradiation; directly package them to obtain traditional Yao bath powder D.

[0040] Comparative Example 2 (without surface modification process) The preparation of the core active ingredient ultrafine powder was the same as in Example 1, resulting in ultrafine powder with D90=4.2μm; without surface modification, the ultrafine powder was directly dried at 60℃ for 2 hours; and then subjected to low-temperature plasma sterilization and packaging in the same manner as in Example 1 to obtain unmodified ultrafine powder E.

[0041] Experimental results The products obtained in Examples 1-3 and Comparative Examples 1-2 were subjected to the following tests, and the results are shown in the table below:

[0042] *Note: Example 2 contains ε-polylysine, which significantly enhances its antibacterial activity.

[0043] Results analysis: Physical properties and stability: The products (A, B, C) of the embodiments of the present invention successfully constructed microspheres with nanoscale particle size and high zeta potential, exhibiting excellent water dispersion stability, with almost no precipitation after standing for 24 hours; while Comparative Example 1 (D) has a large particle size and is prone to precipitation; although Comparative Example 2 (E) is an ultrafine powder, its stability is far worse than that of the embodiments due to the lack of surface modification; accelerated tests show that the nanosphere structure of the present invention (combined with nitrogen-filled packaging) can effectively protect the active ingredients and has excellent stability.

[0044] Protection of active ingredients: The retention rates of heat-sensitive components (polysaccharin and polyphenols) in the products of the examples are all higher than 95%, which is significantly higher than that of the traditional hot air drying and irradiation process of Comparative Example 1 (D) (<73%), proving that the low-temperature freeze drying, low-temperature pulverization and mild sterilization process of the present invention can protect the active ingredients to the greatest extent; the active ingredient retention rate of Comparative Example 2 (E) is also slightly lower than that of the examples because it is not coated.

[0045] Bioactivity: The products of the examples, especially Example 2 (B) containing ε-polylysine, exhibited the strongest in vitro antibacterial and anti-inflammatory activities, with MIC and IC50 values ​​far superior to those of the comparative examples; this was due to the improved dissolution and penetration by nano-sizing, the high retention rate of active ingredients, and the synergistic effect of surface modifiers; Comparative Example 1 (D) had the worst activity due to large loss of activity and coarse particle size.

[0046] The embodiments described above are some, but not all, embodiments of the present invention. The detailed description of the embodiments of the present 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 the present invention without inventive effort are within the scope of protection of the present invention.

Claims

1. A compound nano-powder for antibacterial, dampness-removing, anti-inflammatory, and health-promoting Yao bath, characterized in that, It is made from core active pharmaceutical ingredients and surface-modifying components; The core active ingredient is made from the following raw materials by weight through ultra-fine grinding: 40 parts Polygonum cuspidatum, 30 parts Senecio scandens, 20 parts Portulaca oleracea, 10 parts dried ginger, 5 parts Coptis chinensis, and 5 parts Euphorbia humifusa. The surface-modifying component is one or more of pullulan, chitosan quaternary ammonium salt, and γ-cyclodextrin, and the amount of the surface-modifying component is 1%-10% of the weight of the core active ingredient powder.

2. The antibacterial, dampness-removing, anti-inflammatory, and health-promoting Yao bath compound nanopowder according to claim 1, characterized in that, The core active pharmaceutical ingredient powder has a particle size D90≤5μm. After being treated with surface-modified components through fluidized bed coating or molecular self-assembly technology, it forms nanospheres with an average particle size of 100nm-1μm.

3. The antibacterial, dampness-removing, anti-inflammatory, and health-promoting Yao bath compound nanopowder according to claim 2, characterized in that, The nanospheres have an absolute zeta potential greater than 30 mV and can be stably suspended for more than 24 hours in an aqueous dispersion system with pH 5.5-8.

0.

4. The antibacterial, dampness-removing, anti-inflammatory, and health-promoting Yao bath compound nanopowder according to claim 3, characterized in that, The core active ingredient also includes 2-5 parts by weight of extracts of *Rhizoma Cimicifugae* or *Caulis Paederia scandens*, wherein the extracts are spray-dried powders obtained after water extraction and alcohol precipitation.

5. The antibacterial, dampness-removing, anti-inflammatory, and health-promoting Yao bath compound nanopowder according to claim 4, characterized in that, The surface-modifying component also includes a complex of pullulan and ε-polylysine in a weight ratio of 1:0.5-2.

6. A method for preparing the antibacterial, dampness-removing, anti-inflammatory, and health-promoting Yao bath compound nanopowder as described in any one of claims 1-5, characterized in that, Includes the following steps: Step 1: Weigh the raw medicinal materials of the core active ingredient according to the proportion, and freeze-dry them separately at low temperature of -40℃ to -20℃ to make the moisture content of the medicinal materials less than 5%. After mixing, pulverize them using low temperature supersonic airflow pulverization technology to obtain ultrafine powder of the core active ingredient. Step 2: Dissolve the surface-modifying component in a 40%-60% ethanol-water mixed solvent to prepare a coating solution with a mass concentration of 2%-8%. Step 3: In a high-voltage electrostatic spraying device, the core active pharmaceutical ingredient ultrafine powder is fluidized in a fluidized bed under the protection of inert gas. At the same time, a coating solution with a mass concentration of 2%-8% is atomized and sprayed in at a rate of 0.5-2.0 mL / min, so that the surface modification component crystallizes and coats the powder particles in situ to form nanospheres. The electrostatic spraying voltage is 15-25kV, and the distance between the nozzle and the fluidized powder bed is 10-20cm. Step 4: Collect the product nanospheres, vacuum dry them at 50-60℃ for 2-4 hours, then sterilize them with low-temperature plasma, and package them in aluminum-plastic composite film bags, and fill them with nitrogen for protection.

7. The preparation method according to claim 6, characterized in that, In step 1, the operating temperature of the low-temperature supersonic airflow pulverizer is -10℃ to 10℃, the pulverizing pressure is 0.8-1.2MPa, and the material is pulverized in 3-5 cycles.

8. The preparation method according to claim 6, characterized in that, In step 3, the inert gas is nitrogen or argon, and the fluidizing gas temperature is 25-35℃.

9. The preparation method according to claim 6, characterized in that, In step 4, the parameters for the low-temperature plasma sterilization are: power 300-500W, processing time 5-15 minutes, and working gas is a mixture of argon and oxygen.

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