Fat-reducing patch and preparation method thereof

Abstract

According to the fat reducing patch and the preparation method thereof, the efficient and safe fat reducing effect is achieved through the double-layer structure design and the synergistic effect of traditional Chinese medicine components in combination with the micro-current stimulation technology. The fat-reducing patch comprises an outer patch layer and a patch core layer, the outer patch layer comprises a black hot melt adhesive matrix and a traditional Chinese medicine essential oil mixture, and the essential oil mixture comprises 12 traditional Chinese medicine components such as rhizoma corydalis and radix salviae miltiorrhizae and has the effects of rapid permeation and blood circulation improvement; the paste core layer comprises a transparent hot melt adhesive matrix, traditional Chinese medicine powder and ceramic clay, the traditional Chinese medicine powder comprises eight traditional Chinese medicine components such as gynostemma pentaphylla and ginkgo leaves, and the ceramic clay generates micro-current, enhances transdermal absorption of the medicine, stimulates vein acupuncture points and promotes fat metabolism. The preparation method of the fat-reducing patch comprises the steps of preparation, compounding and forming of the outer patch layer and the paste core layer, the fat-reducing patch suitable for the belly or waist vein acupuncture points of the human body is finally prepared, a step-by-step heating process is adopted, and through high-temperature melting and low-temperature mixing, the activity of traditional Chinese medicine ingredients is protected, and the drug release efficiency and stability are improved.

Description

Technical Field

[0001] The present invention relates to the technical field of external-use weight-loss products, and in particular to a fat-reducing patch that synergizes acupoint stimulation with traditional Chinese medicine ingredients and a preparation method thereof. Background Art

[0002] In today's era of pursuit of health and beauty, weight loss has become a focus of many people. Currently, a wide variety of weight loss methods are available, including oral Chinese and Western medicine, massage at health spas, physical conditioning, acupuncture, cupping, dieting, thread embedding, and gastric surgery. However, each of these methods has limitations. For example, diet can easily lead to nutritional imbalances, which can slow metabolism, cause muscle loss, and lead to malnutrition. While exercise can shape the body and improve cardiopulmonary function and basal metabolic rate, its effects are slow and require long-term persistence. While medications can control appetite, inhibit fat absorption, and speed up metabolism, they can also cause side effects such as cardiovascular problems, liver damage, and endocrine disorders. Surgery, while effective, carries significant risks and is only suitable for severely obese individuals.

[0003] In the field of topical weight loss products, most existing fat-reducing patches on the market are single-layer. This structure results in a low drug loading capacity, and the aroma of traditional Chinese medicine often relies on the addition of fragrances. The actual content of essential oils is minimal or even non-existent, and the powder is often lacking. In terms of effectiveness, these patches only provide a warming sensation, with minimal effect on waist circumference reduction or weight loss, making it difficult to achieve the desired weight loss effect. Summary of the Invention

[0004] The purpose of the present invention is to provide a safe, effective and easy-to-use external fat-reducing patch and its preparation method, which solves the problems of poor effect, low safety and complicated operation of existing weight loss methods and fat-reducing patches through double-layer structure design and the effect of Chinese medicine formula, combined with microcurrent stimulation technology. The fat-reducing patch of the present invention is applied to the belt meridians on both sides of the human body to dredge the meridians, discharge cold and dampness, and burn fat. At the same time, it utilizes the rapid penetration of the Chinese medicine essential oil in the outer layer and the synergistic effect of the Chinese medicine powder and ceramic soil in the paste core layer to achieve a significant fat-reducing effect. The preparation method of the fat-reducing patch of the present invention is simple and easy to implement, and the product has a significant effect in reducing waist circumference and body weight.

[0005] The fat-reducing patch of this invention has a two-layer structure, consisting of an outer layer and a core layer. The outer layer is composed of a hot-melt adhesive matrix containing 12 natural Chinese herbal essential oils, while the core layer is composed of a matrix containing eight Chinese herbal powders, ceramic clay, and transparent hot-melt adhesive. The ceramic clay generates microcurrents through contact with skin moisture, which, combined with the synergistic effect of the Chinese herbal ingredients, stimulates the acupuncture points of the Dai Meridian meridian and promotes fat metabolism and absorption. This fat-reducing patch is safe, highly effective, and has no side effects, resolving the issues of existing fat-reducing patches, which suffer from low drug loading and insignificant effects.

[0006] The present invention adopts a double-layer structure including an outer layer and a core layer to achieve the dual effects of the drug, and utilizes the synergistic effect of the Chinese medicinal essential oil in the outer layer and the Chinese medicinal powder in the core layer to enhance the fat-reducing effect; at the same time, the present invention adds ceramic clay to the core layer and utilizes its microcurrent characteristics to enhance the transdermal absorption of the drug.

[0007] The present invention provides a fat-reducing patch, comprising an outer patch layer and a paste core layer, wherein the outer patch layer comprises a black hot-melt adhesive matrix and a mixture of traditional Chinese medicine essential oils, wherein the mixture of traditional Chinese medicine essential oils comprises, by weight, 10-14 parts of Corydalis yanhusuo, 7-13 parts of Salvia miltiorrhiza, 7-13 parts of Carthamus tinctorius, 4-12 parts of Bupleurum chinense, 4-12 parts of Ilex pubescens, 4-12 parts of Prunella vulgaris, 4-12 parts of Epimedium, 4-12 parts of Pueraria root, 4-12 parts of Cassia seed, 4-12 parts of The paste core layer comprises a transparent hot-melt adhesive matrix, Chinese medicinal powder and ceramic clay, wherein the Chinese medicinal powder comprises, by weight, 10-20 parts of Gynostemma pentaphyllum, 10-20 parts of Ginkgo biloba leaves, 10-20 parts of Alisma orientalis, 10-20 parts of Polygonum cuspidatum, 7-13 parts of pomegranate leaves, 7-13 parts of cinnamon bark, 7-13 parts of cloves and 7-13 parts of galangal, and the ceramic clay comprises 2-8 parts by weight.

[0008] The fat-reducing patch of the present invention adopts a double-sided structural design. The outer layer is composed of a black hot-melt adhesive matrix and a mixture of Chinese medicinal essential oils, wherein the Chinese medicinal essential oil mixture includes 12 Chinese medicinal ingredients, which can quickly penetrate the skin and provide an immediate fat-reducing effect. The addition of menthol-glycerol solution not only enhances the cooling sensation and transdermal absorption efficiency, but also improves the moisturizing and soothing effects of the skin. Its design focuses on rapid action and skin comfort, and is suitable for quickly improving blood circulation and metabolism. At the same time, it simplifies the preparation process and is suitable for large-scale production; the paste core layer is composed of a transparent hot-melt adhesive matrix, Chinese medicinal powder and ceramic clay, wherein the Chinese medicinal powder contains 8 Chinese medicinal ingredients, which can continuously release the medicinal ingredients and provide a stable fat-reducing effect. The addition of ceramic clay can generate microcurrent in contact with skin moisture, stimulate the belt meridian acupoints, and significantly enhance the transdermal absorption of the medicinal ingredients. Its design focuses on sustained action and optimization of drug absorption. At the same time, through the combination of the transparent hot-melt adhesive matrix and ceramic clay, the stability and safety of the drug are ensured, and the risk of skin infection is reduced.

[0009] Among them, the functions of the ingredients in the outer layer include Chinese herbal essential oils: Corydalis yanhusuo: Contains alkaloids such as dihydropalmatine, which has the effects of regulating qi, promoting blood circulation, and relieving pain; in fat-reducing patches, it can improve local blood circulation, promote the absorption of other drug ingredients, regulate nerve functions related to human metabolism, and assist in fat metabolism.

[0010] Salvia miltiorrhiza: Rich in ingredients such as tanshinone, it can promote blood circulation, remove blood stasis, regulate menstruation and relieve pain; it can dilate blood vessels, increase blood flow rate, provide sufficient oxygen and nutrients for fat metabolism, accelerate the excretion of metabolic waste, and facilitate the decomposition and consumption of fat.

[0011] Safflower: Contains safflower yellow pigment, which has the effects of promoting blood circulation, relieving menstruation, dispersing blood stasis and relieving pain; it can improve microcirculation, enhance the ability of external patch drugs to penetrate deep into the skin, and promote material exchange during fat metabolism.

[0012] Bupleurum: Its ingredients such as Bupleurum saponins can relieve liver depression and boost Yang Qi; regulate the body's endocrine system, help maintain hormone balance, affect the synthesis and decomposition of fat, and assist in fat loss.

[0013] Ilex pubescens: Contains flavonoid glycosides, which can invigorate blood circulation, clear away heat and detoxify; improve local blood circulation, eliminate inflammation, create a good environment for fat metabolism, and facilitate the excretion of fat decomposition products.

[0014] Prunella Vulgaris: Contains prurigoside, etc., which has the effects of clearing the liver and purging fire, dispersing stagnation and reducing swelling; regulates the body's internal environment, affects fat cell metabolism, assists in fat reduction and improves local metabolic status.

[0015] Epimedium: Its icariin and other ingredients can replenish kidney yang and strengthen bones and muscles. It regulates the endocrine system, affects hormone levels in the body, indirectly promotes fat metabolism, and improves the body's metabolic capacity.

[0016] Pueraria root: Rich in puerarin, it can relieve muscles and reduce fever, promote salivation and quench thirst; improve microcirculation, promote drug absorption, regulate blood sugar and blood lipid metabolism, and assist in weight control.

[0017] Cassia seed: Contains ingredients such as chrysophanol, which has the effects of clearing the liver and improving eyesight, moistening the intestines and promoting bowel movements; it promotes intestinal peristalsis, helps excrete toxins and waste from the body, reduces fat absorption, and assists in fat loss.

[0018] Rhubarb: Its anthraquinone compounds and other ingredients can purge accumulation, clear away heat and reduce fire; promote intestinal excretion, reduce the absorption and accumulation of fat in the intestines, and accelerate the excretion of metabolic waste in the body.

[0019] Raw hawthorn: Contains hawthorn acid, which can help aid food, strengthen the stomach, promote qi and disperse blood stasis; promote digestion, help break down fat in food, lower blood lipids, and help reduce fat accumulation in the body.

[0020] Atractylodes: Contains volatile oils, which have the effects of drying dampness, strengthening the spleen, dispelling wind and cold; regulating spleen and stomach functions, improving digestion and absorption, reducing water retention in the body, and avoiding obesity caused by water retention.

[0021] The range of the proportions of each component of the Chinese herbal essential oil mixture in the outer layer accurately adjusts the proportions of multiple Chinese herbal essential oils, ensuring that essential oils with different functions work together. For example, the combination of blood-activating essential oils such as Corydalis yanhusuo and Salvia miltiorrhiza can effectively improve local blood circulation and promote drug absorption when used within a specific proportion range; essential oils that regulate endocrine such as Bupleurum chinense and Epimedium can assist in fat metabolism when mixed in corresponding proportions; reasonable proportion control also ensures the stability of product quality and avoids the impact of fluctuations in ingredient proportions on efficacy; at the same time, by adjusting the proportion, it can balance potential irritation and side effects on the basis of exerting efficacy to adapt to the physical differences of different users.

[0022] Among them, the functions of the various components of the outer layer also include the black hot melt adhesive matrix: a thermoplastic adhesive that is solid at room temperature, can flow and be sticky after being heated and melted, and quickly solidifies after cooling. It is mainly composed of ethylene-vinyl acetate copolymer, tackifying resin, paraffin, antioxidants and other ingredients; in the fat-reducing patch, as a carrier of the Chinese herbal essential oils in the outer layer, the black hot melt adhesive matrix can evenly disperse and wrap 12 kinds of natural Chinese herbal essential oils. The continuous phase formed makes the Chinese herbal essential oils stable, prevents the essential oils from volatilizing and leaking, and allows them to continue to play a role, so that the essential oils such as Corydalis yanhusuo and Salvia miltiorrhiza can be evenly distributed in the hot melt adhesive, slowly released during use, and maintain the durability of the medicinal effect; On the one hand, when the hot melt adhesive is heated and melted, it can fit tightly to the skin surface, ensuring that the fat reduction patch is firmly attached to the belt meridian area. Based on the physical properties of the hot melt adhesive, it can fill the tiny gaps in the skin after melting, and generate strong adhesion after cooling and solidification to prevent it from falling off, so that the medicine can continue to act on the acupuncture points and promote absorption; on the other hand, the black hot melt adhesive matrix can adjust the release rate of Chinese herbal essential oils to achieve a sustained-release effect, and the interaction with the essential oils can limit the rapid diffusion of the essential oils, so that the Chinese herbal essential oils can be slowly released over a longer period of time, maintain a stable blood drug concentration, and improve utilization rate, so that safflower essential oil and the like can be continuously released for several hours through the control of the hot melt adhesive matrix, thereby prolonging the action time.

[0023] Among them, the ingredients of the paste core layer include Chinese herbal essential oils: Gynostemma pentaphyllum: Rich in gypenosides, it can regulate lipid metabolism, inhibit fat synthesis, promote fat decomposition, lower blood lipid levels, and reduce fat accumulation in the body.

[0024] Ginkgo leaves: Contain ginkgo flavonoids, which can improve vascular endothelial function, enhance vascular elasticity, promote blood circulation, increase the supply of oxygen and nutrients required for fat metabolism, and accelerate the transport of fat metabolic products.

[0025] Alisma: Its ingredients such as Alisma alcohol have the effect of water-draining and heat-relieving; it promotes the discharge of excess water in the body, reduces edema, regulates water metabolism, and at the same time inhibits fat synthesis to assist in fat loss.

[0026] Polygonum cuspidatum: Contains polydatin, which can eliminate dampness and jaundice, clear away heat and detoxify, disperse blood stasis and relieve pain; improve the body's metabolic environment, promote blood circulation, regulate fat metabolism, and reduce fat accumulation.

[0027] Pomegranate leaves: Contain polyphenols and other ingredients, which have antioxidant and anti-inflammatory effects; regulate the activity of fat cells, improve the local metabolic environment, inhibit the abnormal proliferation of fat cells, and assist in fat reduction.

[0028] Cinnamon: Its ingredients such as cinnamaldehyde can replenish fire and yang, dispel cold and relieve pain, warm the meridians; promote blood circulation, increase the body's metabolic rate, and enhance energy consumption during fat decomposition and metabolism.

[0029] Clove: Contains eugenol, which has the effects of warming the middle and relieving adverse reactions, nourishing the kidneys and supporting yang; it regulates the function of the digestive system, promotes digestion and absorption, enhances the body's metabolic function, and helps decompose and consume fat.

[0030] Alpinia officinalis: Contains volatile oils, which can warm the stomach and dispel cold, help digestion and relieve pain; improve gastrointestinal function, promote digestion, enhance the spleen and stomach's ability to transport and transform, reduce the conversion of food into fat in the body, and assist in fat loss.

[0031] The various Chinese herbs in the paste core layer are combined in specific proportions. Gynostemma pentaphyllum, Ginkgo biloba and other Chinese herbs that regulate lipid metabolism and improve vascular function work synergistically within the range of 10-20 proportions, enhancing the effect of promoting fat decomposition and metabolic waste discharge; pomegranate leaves, cinnamon and other Chinese herbs with antioxidant and meridian-warming effects optimize the local metabolic environment at a ratio of 7-13 proportions; precise proportion regulations standardize product production and ensure consistent quality of each batch of paste core. Adjusting the proportion according to different needs helps to improve the pertinence and effectiveness of the fat-reducing patch and meet diverse fat-reduction needs.

[0032] Among them, the core layer of the paste also includes ceramic clay: a functional material added to the core layer of the fat-reducing patch, the main component of which is clay minerals such as kaolin, and contains a variety of metal oxides; after the ceramic clay comes into contact with the moisture on the surface of the skin, it can conduct electricity through its own special properties, thereby generating microcurrents, which stimulate the acupuncture points of the belt meridian. According to the theory of bioelectric stimulation, it can regulate the bioelectric activity at the acupuncture points, expand the pores of the skin, increase the permeability of the skin, and allow the effective ingredients of the Chinese medicine powder in the core layer of the paste and the Chinese medicine essential oil that penetrates from the outer layer to pass through the skin barrier more smoothly. The human circulatory system can significantly improve the transdermal absorption efficiency of drugs. At the same time, there is a bioelectric phenomenon in the human meridian system. The circulation of qi and blood in the meridians is closely related to the conduction of bioelectricity. The microcurrent generated by ceramic clay stimulates the belt meridian. As the only horizontal meridian in the human body, the belt meridian has important significance for restraining the longitudinal meridians and regulating the circulation of qi and blood. Microcurrent stimulation can dredge the belt meridian, restore or enhance the conduction function of the meridians, and improve the circulation of qi and blood in the meridians. It not only helps the drugs to better act on the whole body, but also regulates the body's own metabolic function, promotes the decomposition and metabolism of fat, and achieves the effect of fat reduction.

[0033] The range of 2-8 parts of ceramic clay in the paste core layer has a key impact on the efficacy of the fat-reducing patch. It is known that an appropriate amount of ceramic clay will generate microcurrent after contacting skin moisture. The intensity of the microcurrent is related to the number of ceramic clay parts. The microcurrent generated by the appropriate number of parts can not only effectively stimulate the belt meridian acupoints, enhance skin permeability, and promote the absorption of Chinese medicine powder and Chinese medicine essential oils in the outer layer, but also regulate the bioelectric activity of the meridians and promote fat metabolism; if the number of parts is too small, the microcurrent stimulation is insufficient, affecting the drug absorption and meridian regulation effect; if the number of parts is too large, the microcurrent will be too strong, causing discomfort to the user; a reasonable range of parts ensures that ceramic clay can improve the fat-reducing effect while protecting the user experience and safety.

[0034] Among them, the function of the core layer ingredients also includes a transparent hot melt adhesive matrix: a thermoplastic material used in the core layer of the fat-reducing patch of the present invention, which is solid at room temperature, melts into liquid when heated to a certain temperature, has good fluidity and viscosity, and can quickly solidify after cooling; it is composed of a variety of high molecular polymers, thickeners, softeners, antioxidants and other ingredients, and serves as a carrier of Chinese medicine powder and ceramic clay in the core layer of the fat-reducing patch. 8 kinds of Chinese medicine powders such as Gynostemma pentaphyllum and Ginkgo biloba and ceramic clay are evenly dispersed and fixed together, so that the core layer has a certain shape and physical stability, ensuring that the Chinese medicine powder and ceramic clay will not be easily separated during use, thereby ensuring the consistency and stability of product quality; on the one hand, during the preparation and use process, the transparent hot melt adhesive matrix has good viscosity after being heated and melted, which can make the core layer of the paste tightly combined with the outer layer, and at the same time, fit closely with the skin when applied. Its bonding principle is based on the thermal conductivity of the hot melt adhesive. Plasticity, the activity of the molecular chain is enhanced when heated, and it can infiltrate the surface of the adherend. After cooling and solidification, a strong adhesive force is formed, which ensures that the core layer of the fat-reducing patch can stably contact the skin when in use, providing good conditions for the Chinese medicine powder and ceramic clay to play a role, preventing the core layer from falling off or shifting, and ensuring that the active ingredients can continue to act on the human body's belt meridian area; on the other hand, the transparent hot melt adhesive matrix can adjust the release rate of the active ingredients in the Chinese medicine powder and ceramic clay, and there is a certain interaction between it and the Chinese medicine powder and ceramic clay, which affects the rate of penetration of the active ingredients into the skin. By selecting a suitable hot melt adhesive formula and preparation process, a slow and continuous release of the active ingredients can be achieved, the action time of the drug can be extended, and the utilization efficiency of the drug can be improved, so that ingredients such as gypenosides in Gynostemma pentaphyllum powder are gradually released over a long period of time, continuously regulating the body's lipid metabolism, thereby better achieving the purpose of fat reduction.

[0035] The present invention precisely controls the mass proportions of the Chinese medicinal essential oil mixture, Chinese medicinal powder and ceramic clay in their respective layers, thereby ensuring the optimal effects of the medicinal components while guaranteeing the stability and safety of the product.

[0036] Preferably, in the outer layer of the fat-reducing patch of the present invention, the mass proportion of the Chinese herbal essential oil mixture is 1%-3% of the total mass of the outer layer; this ratio ensures that the Chinese herbal essential oils therein can exert effective physiological activity. Various Chinese herbal essential oils such as Corydalis yanhusuo and Salvia miltiorrhiza can ensure that sufficient active ingredients penetrate into the skin at this ratio. These essential oils contain effective substances such as tetrahydropalmatine and tanshinone, which can stimulate the acupuncture points near the belt meridian, promote local blood circulation, and create a good internal environment for subsequent fat metabolism; if the ratio is too low, the content of effective ingredients is insufficient, and it is difficult to produce obvious effects such as promoting blood circulation and regulating metabolism, which affects the fat-reducing effect; if the ratio is too high, it causes the local skin to produce an irritation reaction to excessive drug ingredients, causing skin discomfort. On the one hand, the appropriate ratio helps to maintain the overall stability of the outer layer. As a carrier, the black hot melt adhesive matrix needs to achieve an appropriate ratio balance with the Chinese herbal essential oil. The 1%-3% content allows the Chinese herbal essential oil to be evenly dispersed in the black hot-melt adhesive matrix, avoiding the occurrence of essential oil agglomeration and stratification. During storage and use, this stability ensures that the efficacy of each outer layer is uniform and consistent. No matter where the user applies the patch on the belt meridian, they can obtain the same effect, thus improving the reliability of product quality. On the other hand, this content can effectively control the release rate of the Chinese herbal essential oil. After the outer layer is applied to the skin, the Chinese herbal essential oil will gradually release and penetrate. The 1%-3% content combined with the characteristics of the black hot-melt adhesive matrix allows the essential oil to be released at a moderate rate. This can ensure a continuous supply of medicine during the application period and maintain the durability of the efficacy, while also avoiding excessive release, which can cause a large amount of medicine to accumulate on the skin surface in a short period of time, increasing the burden on the skin or causing adverse reactions.

[0037] In the paste core layer, the mass proportion of Chinese medicinal powder is 10%-20% of the total mass of the paste core layer. This proportion ensures that a variety of Chinese medicinal powders can fully exert their respective fat-reducing effects. Chinese medicinal powders such as Gynostemma pentaphyllum, Ginkgo biloba, and Alisma orientalis contain effective ingredients such as gypenosides, ginkgo flavonoids, and alisma alcohol. At this proportion, these ingredients can work synergistically to regulate multiple links of fat metabolism; gypenosides can inhibit fat synthesis, ginkgo flavonoids improve vascular function to promote the transport of fat metabolites, and alisma alcohol can promote water and moisture absorption and assist in the discharge of excess water and fat decomposition products; if the proportion is too low, the effective ingredients are insufficient and it is difficult to have a significant effect on fat metabolism; if the proportion is too high, the synergistic effect of other ingredients will be affected due to the excessive amount of certain ingredients, and may even have adverse effects on the skin or body. The appropriate proportion helps the Chinese medicine powder to be evenly distributed in the transparent hot melt adhesive matrix, ensuring the stability of the paste core layer; during the production process, a proportion of 10%-20% allows various Chinese medicine powders to be fully mixed with the transparent hot melt adhesive matrix, avoiding precipitation, agglomeration and other phenomena; during storage and use, the paste core layer always remains uniform, and each part contains the same proportion of active ingredients, ensuring that users can achieve stable fat reduction effects every time they use it.

[0038] The mass of the ceramic clay accounts for 1%-10% of the total mass of the paste core layer. This range determines the intensity and effect of the microcurrent it generates. When the ceramic clay contacts the moisture on the surface of the skin, it will generate microcurrent and stimulate the acupuncture points of the belt meridian. The proportion of 1%-10% can ensure that the intensity of the generated microcurrent is moderate, which can not only effectively stimulate the acupuncture points, promote the circulation of qi and blood in the meridians, and enhance the skin's absorption of the Chinese medicine powder and the Chinese medicine essential oils in the outer layer, but also will not make the user feel uncomfortable due to excessive current. Under this proportion, the ceramic clay and the Chinese medicine powder cooperate with each other, and the microcurrent stimulation can not only promote drug absorption, but also regulate the body's own physiological functions, enhance the regulatory effect of the Chinese medicine powder on fat metabolism, and promote ingredients such as gypenosin to better enter the cells, acting on the mechanisms related to fat metabolism, thereby more effectively inhibiting fat synthesis, promoting fat decomposition, and improving the overall fat reduction effect.

[0039] The present invention provides a systematic method for preparing a fat-reducing patch, which covers the specific preparation steps of the outer patch layer and the paste core layer as well as the compounding and molding process. It utilizes the dual effects of drug stimulation and physical stimulation to give full play to the double-layer structure and microcurrent characteristics to enhance the fat-reducing effect.

[0040] The present invention provides a method for preparing a fat-reducing patch, comprising the following steps: Preparation of S1 outer layer: Heat the black hot melt adhesive to a molten state, the purpose is to transform it from a solid state to a liquid state, to obtain good fluidity and viscosity. The hot melt adhesive in a molten state can be better mixed with other ingredients, creating conditions for the subsequent uniform dispersion of the Chinese medicine essential oil mixture. Only when the hot melt adhesive is fully melted can it be ensured that after adding the Chinese medicine essential oil mixture, the two can be tightly combined to form a stable system. Add a mixture of Chinese medicine essential oils including 10-14 parts of Corydalis yanhusuo, 7-13 parts of Salvia miltiorrhiza, 7-13 parts of Carthamus tinctorius, 4-12 parts of Bupleurum chinense, 4-12 parts of Ilex pubescens, 4-12 parts of Prunella vulgaris, 4-12 parts of Epimedium, 4-12 parts of Pueraria root, 4-12 parts of Cassia seed, 4-12 parts of Rhubarb, 3-9 parts of Hawthorn, and 3-9 parts of Atractylodes lancea. Various Chinese medicine essential oils such as Corydalis yanhusuo and Salvia miltiorrhiza contain unique active ingredients, which have the effects of promoting blood circulation, regulating endocrine, etc.; after rapid stirring, During film coating, rapid stirring evenly disperses the essential oils in the molten black hot-melt adhesive, ensuring consistent composition and uniform efficacy across the outer layer. This even dispersion also ensures sustained and stable release of the essential oils during subsequent use, maximizing their fat-reducing properties. The essential oil mixture should account for 1%-3% of the total outer layer weight, ensuring sufficient active ingredients for efficacy while avoiding skin irritation or degradation of the hot-melt adhesive due to excessive concentrations. The film coating process, followed by uniform stirring, allows the blended material to be formed into a suitable shape for application. This coating process allows for control of the thickness and surface area of ​​the outer layer to meet product design requirements. The appropriate thickness ensures sufficient essential oil content without compromising application comfort, while the appropriate surface area ensures adequate contact with the body's girdle meridians, enhancing the drug's effectiveness. Furthermore, the film-forming outer layer possesses a degree of flexibility and adhesion, facilitating subsequent lamination with the core layer and application to the skin.

[0041] Preparation of S2 paste core layer: The transparent hot melt adhesive is heated to a molten state. The purpose of melting the black hot melt adhesive is similar to that of melting the black hot melt adhesive, which is to make the transparent hot melt adhesive have good fluidity and viscosity. When the Chinese herbal medicine powder and ceramic clay are added, they can better wrap and disperse these ingredients to form a uniform paste core layer system. Chinese herbal medicine powders including 10-20 parts of Gynostemma pentaphyllum, 10-20 parts of Ginkgo biloba leaves, 10-20 parts of Alisma orientalis, 10-20 parts of Polygonum cuspidatum, 7-13 parts of Pomegranate leaves, 7-13 parts of Cinnamon bark, 7-13 parts of Cloves, and 7-13 parts of Alpinia officinalis, and 2-8 parts of ceramic clay are added. Various Chinese herbal medicine powders such as Gynostemma pentaphyllum and Ginkgo biloba have their own functions of regulating fat metabolism and improving vascular function, and they work synergistically to promote fat reduction. The ceramic clay can generate microcurrents after contacting skin moisture, stimulating acupuncture points and promoting drug absorption. The uniform mixing ensures the consistency of the proportions of the ingredients in the paste core layer and the stability of product quality. The weight of the Chinese herbal powder accounts for 10%-20% of the total weight of the paste core layer, and the weight of the ceramic clay accounts for 1%-10% of the total weight of the paste core layer. This ensures that the Chinese herbal powder can fully exert its fat-reducing efficacy, and that the ceramic clay can generate a microcurrent of appropriate intensity to enhance drug absorption, while avoiding product performance or adverse reactions due to improper ingredient ratios. The coating and film formation process is similar to the coating and film formation in the preparation of the outer patch layer. The coating and film formation of the paste core layer is to give it a specific shape and thickness to meet the product's usage requirements. The appropriate thickness can ensure the content of the Chinese herbal powder and ceramic clay, ensuring the efficacy and microcurrent stimulation effect. At the same time, the film-formed paste core layer has a certain degree of flexibility and viscosity, which is convenient for compounding with the outer patch layer. It can better adhere to the skin during application, allowing the active ingredients to act more effectively on the human body.

[0042] S3 Compounding and Molding: The prepared outer patch layer is compounded with the core layer of the paste so that the two are tightly combined; the Chinese herbal essential oils in the outer patch layer and the Chinese herbal powder and ceramic clay in the core layer cooperate with each other to jointly exert a fat-reducing effect; the Chinese herbal essential oils in the outer patch layer can penetrate the skin and promote local blood circulation, while the Chinese herbal powder in the core layer is absorbed through the skin to exert its fat-reducing effect, and the microcurrent generated by the ceramic clay further enhances the drug absorption effect; the compounding process ensures that the two functional layers can work together to improve the overall efficacy of the fat-reducing patch. The compounded material is cut into patches in order to make it into a specification that is easy to use. Cutting it into patches of appropriate size allows users to apply it to the human body's meridian area as needed. At the same time, the standardized cutting size also facilitates the packaging, storage and sales of the product. By cutting it into patches, the final shaping of the fat-reducing patch is completed, making it a product that can be used directly.

[0043] The present invention accurately controls the temperature and time during the preparation of the outer coating layer, thereby ensuring uniform dispersion of the traditional Chinese medicine essential oil mixture and improving the quality stability of the product.

[0044] Preferably, the preparation method of the fat-reducing patch of the present invention, wherein the preparation of the outer patch layer specifically comprises the following steps: S11 Hot Melt Adhesive Melting: Heat the black hot melt adhesive to 70-80°C. At this temperature, the black hot melt adhesive can completely melt, transforming from a solid to a liquid state, and has good fluidity. If the temperature is lower than 70°C, the hot melt adhesive will not melt completely, and solid particles will be present, affecting the uniformity of subsequent mixing with the Chinese herbal essential oils, resulting in uneven distribution of the ingredients in the outer layer and affecting the efficacy of the medicine. If the temperature is higher than 80°C, the chemical structure of the hot melt adhesive will change, reducing its viscosity and stability, affecting the adhesion of the outer layer to the skin and the shelf life of the product. Make it completely melted and have good fluidity. A completely melted and fluid hot melt adhesive can provide an ideal medium for the addition and uniform dispersion of Chinese herbal essential oils. In this state, the Chinese herbal essential oils can be more easily incorporated into the hot melt adhesive, and subsequent stirring can achieve faster and more uniform mixing, helping to form a stable outer layer system and ensure consistent product quality.

[0045] S12 Traditional Chinese Medicine Essential Oil Mixing: Weigh a mixture of traditional Chinese medicine essential oils according to the formula ratio, including 12 kinds of traditional Chinese medicine essential oils such as Corydalis yanhusuo, Salvia miltiorrhiza, and Carthamus tinctorius; slowly add the traditional Chinese medicine essential oil mixture into the molten hot melt adhesive at 60℃-70℃. Add the traditional Chinese medicine essential oil mixture at 60℃-70℃. On the one hand, this temperature is slightly lower than the melting point of the hot melt adhesive, which can ensure that the hot melt adhesive still has good fluidity and is convenient for the dispersion of the traditional Chinese medicine essential oils, and can also avoid excessive volatilization of volatile components in the traditional Chinese medicine essential oils due to excessively high temperature, thereby losing effective ingredients and reducing the efficacy of the fat-reducing patch. On the other hand, the appropriate temperature helps to maintain the chemical stability of the traditional Chinese medicine essential oils and prevent them from deteriorating due to chemical reactions during the mixing process; slow addition allows the traditional Chinese medicine essential oils to gradually blend into the hot melt adhesive, avoiding excessive local concentration due to too fast addition speed, which makes it difficult to disperse evenly. Continuous stirring uses mechanical action to evenly distribute every drop of Chinese herbal essential oil in the hot melt adhesive, ensuring that the composition and efficacy of each part of the outer patch are consistent. Only by uniform dispersion can it be ensured that in the subsequent use process, no matter where it is applied, the amount of Chinese herbal essential oil and efficacy released by the outer patch are the same, providing users with a stable fat reduction effect.

[0046] S13 coating and molding: evenly coating the mixed paste on the release paper to ensure the uniformity of the thickness of the outer layer. The uniform thickness ensures that the content of Chinese herbal essential oils in the outer layer is consistent in all parts, thereby ensuring the consistency of the efficacy. If the coating is uneven, the content of Chinese herbal essential oils in some areas will be too high, increasing the risk of skin allergies, while the content in some areas will be too low, and the expected fat reduction effect cannot be achieved. Peel off after cooling and solidification. Cooling and solidification is to transform the outer layer from liquid to solid, forming a membrane structure with a certain strength and shape. During the cooling process, the molecules in the hot melt adhesive gradually arrange tightly, solidify and form, and fix the Chinese herbal essential oil components; after solidification, peel off from the release paper. The release paper facilitates coating and prevents the outer layer from adhering to other objects before molding. The outer layer obtained after peeling has good flexibility and stickiness, which is convenient for subsequent compounding with the paste core layer and application on the skin. According to the product design requirements, the outer layer is cut into a specific shape so that it can better fit the contour of the human body's girdle area. The appropriate shape not only improves the user's comfort, but also ensures that the outer layer is in full contact with the skin, which is beneficial to the penetration and absorption of Chinese herbal essential oils, thereby enhancing the efficacy of the fat-reducing patch. At the same time, the standardized shape also facilitates product packaging, storage and use.

[0047] Furthermore, the preparation of the outer layer in the preparation method of the fat-reducing patch of the present invention also includes the following operations: adding menthol to glycerol preheated to 40°C-50°C, the mass of glycerol being 2-10 times that of menthol, stirring evenly to form a menthol-glycerol solution, and then adding it to the mixed system of black hot melt adhesive and traditional Chinese medicine essential oil, and continuing to stir at 60°C-70°C for 1-3 minutes to ensure that the menthol and glycerol are evenly dispersed and fully mixed with other ingredients; the amount of the menthol-glycerol solution is 0.1%-5% of the total mass of the outer layer. Within this range, menthol can play its role in promoting blood circulation, enhancing drug penetration, etc., and synergize with traditional Chinese medicine essential oil to improve the fat-reducing effect of the fat-reducing patch. If the amount is less than 0.1%, no significant synergistic effect can be achieved; and if the amount exceeds 5%, the risk of adverse reactions such as skin allergies will increase, and it will also affect the viscosity and stability of the black hot melt adhesive, thereby affecting the overall quality of the fat-reducing patch.

[0048] Menthol is a solid at room temperature. Directly adding it to a mixture of black hot-melt adhesive and traditional Chinese medicine essential oils makes it difficult to disperse quickly and evenly, resulting in clumping and impacting the quality and stability of the final product. However, adding it to glycerin preheated to 40°C-50°C can be beneficial. Glycerin has excellent solubility and stability, acting as a solvent within this temperature range to fully dissolve menthol. A glycerin mass 2-10 times that of menthol ensures complete dissolution, forming a uniform solution and paving the way for subsequent mixing with other ingredients. Menthol is also somewhat irritating, and direct contact with the skin can cause discomfort. Glycerin has moisturizing, hydrating, and soothing properties, forming a protective film that reduces moisture loss and maintains skin suppleness and elasticity. It also provides a stable carrier for menthol. Dissolving menthol in glycerin can reduce its irritation and ensure a more uniform application. When applied to the skin, the skin-reducing patch offers a cooling sensation while minimizing adverse reactions such as allergies and stinging, thereby enhancing product safety and comfort. The viscosity of glycerol can further enhance the adhesion of the drug, making it more suitable for application on the skin. Its flexibility can improve the physical properties of the drug, making it more suitable for application on the skin and reducing crystallization or stratification caused by excessive concentration of drug ingredients.

[0049] Add the prepared menthol-glycerol solution to the mixture of black hot-melt adhesive and Chinese herbal essential oils and continue stirring at 60-70°C for 1-3 minutes to ensure good fluidity of the mixed system and maintain the chemical stability of each component. Continuous stirring allows the menthol-glycerol solution to be fully mixed with the black hot-melt adhesive and Chinese herbal essential oils, ensuring that menthol, glycerol, and other ingredients are evenly distributed throughout the outer layer. Menthol has low volatility, and when mixed with glycerol, it can reduce the volatilization of other Chinese herbal essential oil components, thereby improving the stability of the entire outer layer and extending the shelf life of the product. Uniform distribution of ingredients ensures consistent performance and efficacy across all parts of the fat-reducing patch, avoiding local differences in effect. Menthol has cooling, antipruritic, and blood circulation-promoting properties. It works synergistically with the various ingredients in the TCM essential oil blend to enhance the efficacy of the outer patch. Menthol's fat solubility can temporarily alter the structure of the skin's stratum corneum, increasing skin permeability and promoting better penetration of the TCM essential oil into the skin, improving drug absorption efficiency and thereby enhancing the fat-reducing effect of the fat-reducing patch. The cooling sensation brought by menthol also provides comfort to the user, distracting them from the application area and reducing minor discomfort (such as fever and stinging) caused by the drug's effects, thereby enhancing the product's user experience. Menthol has certain antibacterial and anti-inflammatory properties, which can reduce the growth of bacteria on the skin due to the closed local environment during application, reducing the risk of infection and alleviating minor inflammatory reactions caused by drug stimulation. Menthol activates cold receptors on the skin, producing a cooling sensation, thereby regulating local skin temperature perception and alleviating discomfort caused by drug metabolism or ambient temperature changes. It also regulates the activity of local nerve endings, indirectly affecting the neural signaling associated with fat metabolism, thereby acting together with the TCM ingredients to promote fat decomposition and metabolism.

[0050] The present invention describes in detail the preparation steps of the paste core layer, including the melting of hot melt adhesive, the mixing of Chinese medicinal powder and ceramic clay, and the coating and molding process, to ensure the quality stability of the paste core layer and improve the overall performance of the product.

[0051] Preferably, the preparation method of the fat-reducing patch of the present invention, wherein the preparation of the paste core layer specifically comprises the following steps: S21 Hot Melt Adhesive Melting: Heat the transparent hot melt adhesive to 70-80°C until it completely melts and maintains good fluidity. At this temperature, the intermolecular forces of the hot melt adhesive weaken, and the molecular mobility increases, resulting in good fluidity. The transparent hot melt adhesive completely melts from a solid state to a liquid state. If the temperature is below 70°C, the hot melt adhesive will not completely melt, and unmelted solid particles will remain, affecting the subsequent mixing uniformity with the Chinese herbal medicine powder and ceramic clay. If the temperature is above 80°C, the chemical properties of the hot melt adhesive will change, reducing its viscosity and stability, affecting the quality and performance of the paste core layer. Continuous stirring is also required to prevent clumping during the heating process. During the melting process, the hot melt adhesive can form lumps due to localized uneven heating or other factors, which can disrupt the uniformity of the hot melt adhesive. Continuous stirring ensures that all parts of the hot melt adhesive are heated evenly, maintaining overall fluidity and uniformity. This creates favorable conditions for the subsequent addition of Chinese herbal medicine powder and ceramic clay, ensuring the stability of the final paste core layer.

[0052] S22 Mixing: Mixing at 60-70°C ensures that the hot melt adhesive still has good fluidity, facilitating the addition and dispersion of Chinese medicine powder and ceramic clay, while also preventing the active ingredients in the Chinese medicine powder from being damaged by excessively high temperatures. Many Chinese medicine ingredients will undergo chemical reactions or volatilize at high temperatures, resulting in reduced efficacy. At this appropriate temperature, the active ingredients of the Chinese medicine powder can be retained to the greatest extent, ensuring the fat-reducing effect of the core layer. Add the mixed Chinese medicine powder and ceramic clay to the molten hot melt adhesive in proportion and stir for 10-15 minutes to ensure that the ingredients are evenly dispersed. A sufficiently long stirring time ensures that the Chinese medicine powder and ceramic clay are evenly dispersed in the hot melt adhesive. Only when the Chinese medicine powder and ceramic clay are evenly distributed can the ingredients and properties of each part of the core layer be consistent. Uneven dispersion will lead to local differences in efficacy, affecting the overall effect of the fat-reducing patch. Moreover, the evenly dispersed ceramic clay can generate microcurrents more evenly after contacting the moisture in the skin, enhancing the stimulation effect on the acupuncture points.

[0053] S23 Coating and Forming: The mixed paste is evenly applied to the release paper, ensuring a uniform thickness of the core layer. This uniform thickness ensures consistent content and distribution of the herbal powder and ceramic clay throughout the core layer, ensuring that the core layer exerts its effects uniformly across all areas during application. Uneven application can result in excessive or insufficient concentrations of the herbal ingredients in certain areas, affecting the stability and reliability of the fat-reducing effect. Cooling and curing transform the paste from a liquid to a solid state, forming a core layer with a defined strength and shape. During the cooling process, the hot-melt adhesive molecules gradually align, securing the herbal powder and ceramic clay in place. After curing, the paste is peeled from the release paper, which facilitates application and prevents sticking. Cutting the peeled core layer into the desired shape allows it to better conform to the body's girdle meridian area, facilitating application while meeting product design and packaging requirements, enhancing its practicality and market competitiveness.

[0054] The present invention adds silver nanoparticles to the paste core layer, utilizing their high conductivity and antibacterial properties to enhance the conduction effect of microcurrent while providing antibacterial protection. The dosage of silver nanoparticles is precisely controlled to ensure their synergistic effect with other ingredients, thereby improving the overall effect of the product.

[0055] Furthermore, the preparation method of the fat-reducing patch of the present invention, the preparation of the paste core layer specifically includes the following operations: slowly adding silver nanoparticles accounting for 0.2%-1.0% of the total mass of the paste core layer to a transparent hot melt adhesive system that has been mixed with traditional Chinese medicine powder and ceramic clay, continuing to stir for 5-10 minutes, ensuring that the silver nanoparticles are evenly dispersed, and then continuing to coat and form.

[0056] Silver nanoparticles have excellent antibacterial properties. When applied to human skin, the area of ​​application is relatively closed, warm, and humid, making it prone to bacterial growth. Adding silver nanoparticles, representing 0.2%-1.0% of the total mass of the core layer, effectively inhibits bacterial growth and reproduction, reducing the risk of infection at the application site and safeguarding the user's skin health. They inhibit the growth of common skin pathogens such as Staphylococcus aureus and Escherichia coli, and reduce adverse reactions such as skin inflammation caused by bacterial infections. Ceramic clay generates a microcurrent upon contact with skin moisture. Silver nanoparticles have excellent electrical conductivity. Once evenly dispersed in the core layer, the silver nanoparticles act as a conductive medium, enhancing the conductivity of the microcurrent generated by the ceramic clay. This allows the microcurrent to more effectively stimulate the body's belt meridian acupuncture points, promoting the circulation of qi and blood, further improving the transdermal absorption efficiency of the active ingredients in the traditional Chinese medicine powder, and enhancing the overall efficacy of the fat-reducing patch. The small size effect of silver nanoparticles gives them a larger specific surface area and higher surface activity. They interact with the active ingredients in traditional Chinese medicine powder, change the structure and properties of the skin's stratum corneum, reduce the skin's barrier function, and thus promote drug penetration. The active ingredients in traditional Chinese medicine powder can enter the human blood circulation faster and more effectively, exerting a fat-reducing effect.

[0057] Continue stirring for 5-10 minutes to ensure that the silver nanoparticles are evenly dispersed in the transparent hot melt adhesive system that has been mixed with traditional Chinese medicine powder and ceramic clay. Only uniform dispersion can ensure that the antibacterial properties, microcurrent conduction properties and drug penetration promotion effects of all parts of the paste core layer are consistent; uneven distribution of silver nanoparticles will lead to poor local antibacterial effects, differences in microcurrent conduction or uneven drug penetration, affecting the overall quality and effect of the fat reduction patch.

[0058] Evenly dispersed silver nanoparticles can better synergize with traditional Chinese medicine powder and ceramic clay, and can fully contact with the active ingredients in the traditional Chinese medicine powder to promote the release and penetration of the drugs; at the same time, silver nanoparticles and ceramic clay work together to enhance the stimulation effect of microcurrent; through uniform stirring, the interaction between the various ingredients is made more stable and effective, thereby improving the overall performance of the fat reduction patch.

[0059] After the silver nanoparticles are evenly dispersed, the coating and molding process continues to ensure the structural and performance integrity of the core layer. During the coating process, the evenly dispersed silver nanoparticles, traditional Chinese medicine powder, and ceramic clay, along with the hot melt adhesive, form a uniform paste layer. After cooling and solidification, these ingredients are fixed in the core layer, forming a stable whole, ensuring that the fat-reducing patch can continue to function consistently and stably during use. The core layer of the paste after coating and molding can be cut and manufactured into a shape and size that meets the product design requirements. This core layer can be perfectly combined with the outer layer to form a complete fat-reducing patch product, which is convenient for users to apply to the human body's belt meridian area to achieve the purpose of fat reduction. At the same time, the standardized molding process also facilitates large-scale production and quality control of the product.

[0060] The present invention adopts a step-by-step heating method, and adopts a staged temperature control strategy from high-temperature melting to cooling and mixing, which not only ensures the fluidity of the hot melt adhesive but also reduces the degradation of traditional Chinese medicine ingredients. By precisely controlling the heating temperature and steps, the stability of the ingredients at different stages is ensured. By reducing the exposure time of the ingredients to high temperatures, the active ingredients in traditional Chinese medicine essential oils and traditional Chinese medicine powders are effectively protected. By optimizing the heating process, the mixing efficiency is improved and the uniform distribution of the ingredients is ensured. The step-by-step heating ensures the uniform distribution of ceramic clay and silver nanoparticles, optimizes the conduction effect of microcurrent, and improves the stability and safety of the product.

[0061] The typical melting point range for low-temperature hot-melt adhesives is 60-80°C. Volatile components (such as terpenes and esters) in traditional Chinese medicine essential oils (e.g., Corydalis yanhusuo and Danshen essential oils) partially volatilize at 65-70°C, reducing the content of the active ingredient. Heat-sensitive components (such as polysaccharides and flavonoids) in traditional Chinese medicine powders (e.g., Gynostemma pentaphyllum and Polygonum cuspidatum) can degrade or oxidize if exposed to high temperatures for extended periods. Excessively high temperatures accelerate hot-melt adhesive aging and produce harmful gases (e.g., colloid decomposition), while insufficient temperatures can lead to excessively high colloid viscosity, affecting mixing uniformity with the traditional Chinese medicine ingredients. Therefore, the present invention employs step-by-step heating control for the hot-melt adhesive and traditional Chinese medicine ingredients, using pre-melting and cooling mixing to control the temperature in stages to protect the active ingredients. The hot-melt adhesive is first heated to 5-10°C above its melting point to ensure complete melting and good fluidity, avoiding local overheating caused by premature addition of the traditional Chinese medicine ingredients. After the hot-melt adhesive has melted, the temperature is lowered and the traditional Chinese medicine essential oil or powder is added, minimizing damage to the active ingredients caused by high temperatures. The temperature gradient is adjusted according to different ingredients. For the outer layer containing essential oil, since the essential oil is volatile, the present invention controls the mixing temperature at 60-65°C and shortens the heating time (stirring time ≤ 10 minutes) to ensure that the essential oil retention rate is improved while the patch viscosity meets the standard; for the paste core layer containing medicinal powder, since the medicinal powder is relatively stable, the temperature is slightly increased to 65-70°C, but long-term high temperature should be avoided (stirring time ≤ 15 minutes) to ensure that the loss of active ingredients of the medicinal powder is reduced while the stability of the microcurrent is improved.

[0062] Furthermore, in the preparation method of the fat-reducing patch of the present invention, the heating is step-by-step heating, specifically including preliminary melting and cooling and mixing; the preliminary melting includes: heating the hot melt adhesive to 70°C-80°C. This temperature range can make the hot melt adhesive quickly change from solid to liquid, so that it is initially melted at high temperature and has a certain fluidity; at this high temperature, the force between the hot melt adhesive molecules is effectively weakened, and the molecular motion is intensified, thereby achieving rapid and complete melting, so that the hot melt adhesive has a certain fluidity, providing a good foundation for subsequent mixing with other ingredients. If the temperature is too low, the hot melt adhesive will not melt completely, which will affect the mixing effect and the quality of the final product; a higher temperature can shorten the melting time of the hot melt adhesive, and in large-scale production, it can significantly improve production efficiency and reduce production costs. The hot melt adhesive after preliminary melting can still maintain good fluidity during the subsequent cooling process, which is convenient for the next step of operation.

[0063] The cooling and mixing comprises: after lowering the temperature to 60°C-70°C, adding a mixture of Chinese medicinal essential oils or Chinese medicinal powder and ceramic clay for mixing; wherein when preparing the outer layer, the temperature is lowered to 60°C-65°C, and then the Chinese medicinal essential oil mixture is added for mixing; when preparing the paste core layer, the temperature is lowered to 65°C-70°C, and then the Chinese medicinal powder and ceramic clay are added for mixing.

[0064] The traditional Chinese medicine essential oil mixture in the outer layer contains a variety of volatile and heat-sensitive components, such as the active ingredients in essential oils such as Corydalis yanhusuo and Danshen. Adding the traditional Chinese medicine essential oil mixture when the temperature drops to 60°C-65°C can prevent the damage of these components caused by high temperature. Excessively high temperatures can cause the volatile components in the essential oils to evaporate excessively, reducing the content of the active ingredients and affecting the efficacy of the fat-reducing patch. Mixing at this relatively low temperature can maximize the retention of the active ingredients of the traditional Chinese medicine essential oils and ensure the efficacy of the product. At 60°C-65°C, the hot melt adhesive still has a certain degree of fluidity. Adding the traditional Chinese medicine essential oil mixture at this time and stirring can evenly disperse the traditional Chinese medicine essential oils in the hot melt adhesive. The moderate temperature helps control the mixing process, avoiding problems such as uneven mixing or bubbles caused by excessively high temperatures, thereby ensuring the consistency of the composition and performance of each part of the outer layer.

[0065] The Chinese herbal powder in the paste core layer contains a variety of active ingredients, such as the effective ingredients in traditional Chinese medicines such as Gynostemma pentaphyllum and Ginkgo biloba. Adding the Chinese herbal powder and ceramic clay for mixing at a temperature of 65℃-70℃ can avoid the influence of high temperature on these ingredients; some Chinese herbal ingredients will undergo chemical reactions or denaturation at high temperatures, thereby reducing their biological activity. Appropriately lowering the temperature can protect these active ingredients and ensure the fat-reducing effect of the paste core layer; within this temperature range, the fluidity of the hot melt adhesive is still suitable for mixing operations. During the stirring process, the Chinese herbal powder and ceramic clay can be better integrated with the hot melt adhesive to form a stable system. At the same time, this temperature is also conducive to the dispersion of ceramic clay in the hot melt adhesive, so that it can generate microcurrent more evenly in subsequent use, thereby enhancing the efficacy of the fat-reducing patch.

[0066] Therefore, the step-by-step heating technology of the present invention has significant comprehensive advantages over traditional heating methods in the preparation of fat-reducing patches. Through the step-by-step operation of initial melting and cooling and mixing, the activity of traditional Chinese medicine ingredients is effectively protected, and the destruction of volatile and heat-sensitive ingredients by high temperature is avoided, thereby ensuring the efficacy of the medicine; at the same time, the technology optimizes the viscosity and fluidity of the hot melt adhesive, achieves uniform distribution of drug ingredients, and improves the mixing effect and stability of drug release; in addition, step-by-step heating also enhances the microcurrent conduction effect, improves the transdermal absorption efficiency of the drug, and by reducing the high-temperature treatment time, reduces energy consumption, improves production efficiency and safety, which not only improves the overall performance of the product, but also provides a more efficient and stable solution for the development of external weight loss products.

[0067] This invention details the compounding and molding process, including the stacking, compaction, cooling, and solidification of the core and outer layers, as well as cutting and molding. This ensures the product's structural stability and performance, improving its overall quality. By optimizing the compounding process, the microcurrent conduction efficiency is ensured, further enhancing the performance of the fat-reducing patch.

[0068] Preferably, the preparation method of the fat-reducing patch of the present invention, the compounding and molding specifically include the following operations: laying the paste core layer flat on the release paper, the surface of the release paper is smooth and has anti-stick properties, and laying the paste core layer flat on it can provide a flat and stable foundation for subsequent operations, which can more conveniently handle the paste core layer, and can also accurately control the position and shape of the paste core layer to ensure that it meets the product design requirements; the release paper can prevent the paste core layer from being contaminated or damaged during operation. During subsequent operations such as covering the outer layer and compacting, the release paper can play an isolation and protection role to ensure the integrity and quality of the paste core layer.

[0069] Cover the outer layer and compact it to expel bubbles and achieve a tight bond. Covering the outer layer and then compacting it can make the outer layer fit tightly with the core layer, which is crucial to the overall performance of the fat-reducing patch. Only when the two layers are tightly combined can the Chinese herbal essential oil mixture and effective ingredients such as Chinese herbal powder and ceramic clay work synergistically to improve the fat-reducing effect. Tight fit can also ensure smoother drug delivery and interaction between the two layers. Expelling bubbles during the covering and compacting process can avoid the impact of bubbles on the quality and performance of the fat-reducing patch. The presence of bubbles will cause gaps between the two layers, affecting the delivery and penetration of drugs, reducing the effectiveness of the fat-reducing patch, and affecting the comfort of the patch, and even causing the patch to be loose. After the bubbles are expelled, the structure of the fat-reducing patch can be made more uniform and stable, improving the quality and reliability of the product.

[0070] The patch solidifies through natural or accelerated cooling. The cooling process transforms the hot melt adhesive matrix (the black hot melt adhesive in the outer layer and the transparent hot melt adhesive in the core layer) from a liquid to a solid state, thereby fixing the structure of the outer layer and the core layer. During the curing process, the bond between the two layers becomes stronger, and the active ingredients are stably encapsulated, ensuring the stability and effectiveness of the fat reduction patch during use. Depending on actual production needs, natural or accelerated cooling can be selected. Natural cooling is suitable for applications with low production speed requirements, allowing for slow curing and ensuring quality. Accelerated cooling, on the other hand, allows the patch to solidify and take shape in a shorter time, improving production efficiency and meeting the needs of large-scale production.

[0071] The cured patch is then cut into the desired shape to better fit the body's girdle area. The appropriate shape improves the patch's comfort and fit, ensuring full contact with the skin, which facilitates drug absorption and effectiveness. Different shape designs can also be adjusted based on market demand and user preferences, improving product applicability and competitiveness. Standardized shape cutting facilitates packaging and sales of the patch. Uniform shapes and sizes facilitate product packaging design, storage, and transportation, while also allowing consumers to more intuitively understand the product's specifications and usage instructions.

[0072] The fat-reducing patch of the present invention achieves a triple effect of "fast-acting-sustained-release-physical enhancement" through the rapid penetration of essential oil in the outer layer, continuous release of medicinal powder in the paste core layer, and microcurrent stimulation of ceramic clay; the active ingredients are protected through a step-by-step heating and cooling mixing process, and the double-layer composite structure optimizes drug delivery efficiency; and the antibacterial and transdermal functions are further expanded by the addition of silver nanoparticles and menthol.

[0073] The present invention clearly states that the application site of the fat-reducing patch is the abdomen or waist area of ​​the human body, especially the belt meridian acupoints. This specific application site selection can better exert the effects of the drug and microcurrent stimulation, thereby improving the fat-reducing effect; through the combination of the double-layer structure drug effect and microcurrent stimulation, the present invention provides a comprehensive fat-reducing mechanism.

[0074] Preferably, the fat-reducing patch provided by the present invention is applied to the abdomen or waist area of ​​the human body, preferably to the acupuncture points of the belt meridian, and achieves a fat-reducing effect through the action of the double-layer structure drug and microcurrent stimulation.

[0075] The abdomen and waist are typically areas where fat accumulates most easily. Applying a fat-reducing patch to these areas allows the medication and microcurrent to act directly on the fat deposits, promoting fat breakdown and metabolism in a more targeted manner. For example, the subcutaneous fat layer in the abdomen is thicker, allowing the active ingredients of the fat-reducing patch to penetrate into the adipose tissue, accelerating the breakdown of triglycerides within fat cells and reducing fat storage. Furthermore, the abdomen and waist are rich in vascular networks, resulting in relatively strong blood circulation. This facilitates faster absorption of the medication into the circulatory system and its distribution throughout the body, achieving its fat-reducing effect. Furthermore, good blood circulation provides ample oxygen and nutrients for fat metabolism and promotes the excretion of metabolic waste.

[0076] The Dai Mai (Belt Meridian) is one of the eight extraordinary meridians in the human body. It encircles the waist and plays a vital role in regulating the body's qi and blood. Stimulating the Dai Mai acupoints can dredge the meridians, regulate the flow of qi and blood, and facilitate metabolism. When the meridians are flowing smoothly, the body's various physiological functions can function normally, which helps metabolize and consume fat. The Dai Mai is also connected to several organs in the human body, such as the spleen, stomach, liver, and kidneys. Normal spleen and stomach function aids in the digestion and absorption of food, preventing excessive energy from being converted into fat storage; the metabolic function of the liver and kidneys also plays a key role in fat metabolism. Stimulating the Dai Mai acupoints can indirectly regulate the functions of these organs, promoting the breakdown and excretion of fat, and achieving the goal of fat loss.

[0077] The outer layer of the double-layer structure contains traditional Chinese medicine essential oils, such as Corydalis yanhusuo, salvia miltiorrhiza, and safflower, which have the effect of promoting blood circulation and removing blood stasis, dilating blood vessels, increasing blood flow, and improving local blood circulation. Good blood circulation can provide sufficient oxygen and nutrients for fat metabolism, while also promptly excreting metabolic waste from the body, promoting the breakdown and consumption of fat. Some traditional Chinese medicine essential oils, such as bupleurum and epimedium, have endocrine regulatory effects. The balance of the endocrine system is crucial for fat metabolism. By regulating the endocrine system, it can influence the levels of hormones in the body, such as insulin and adrenaline, thereby promoting the breakdown of fat and inhibiting its synthesis.

[0078] The traditional Chinese medicine powders in the double-layer paste core, such as Gynostemma pentaphyllum, Ginkgo biloba, and Alisma orientalis, contain a variety of active ingredients that can regulate multiple aspects of fat metabolism. For example, gypenosides can inhibit the activity of lipase, reducing fat synthesis; ginkgo flavonoids can improve endothelial function and promote the transport and clearance of fat metabolites; and alisma alcohol can promote diuresis and eliminate dampness, promoting the excretion of excess water and fat breakdown products. Some ingredients in the traditional Chinese medicine powders can also improve the body's metabolic environment and increase the body's basal metabolic rate. An increased basal metabolic rate means that the body consumes more energy at rest, helping to reduce fat storage.

[0079] Microcurrent stimulation can enhance drug absorption, regulate nerve function, and promote the circulation of qi and blood through the meridians. The microcurrent generated by the ceramic clay stimulates acupuncture points and meridians on the skin's surface, dilating pores and increasing skin permeability. This facilitates the effective ingredients in the herbal essential oils in the outer layer and the herbal powder in the core layer to more smoothly penetrate the skin barrier and enter the human blood circulation system, improving drug absorption and enhancing fat-reducing effects.

[0080] Microcurrent stimulation can regulate the body's nerve function and affect the release and transmission of neurotransmitters. By regulating nerve function, it can improve the body's metabolic regulation mechanism, promote the decomposition and metabolism of fat, stimulate the sympathetic nerves, increase the secretion of hormones such as adrenaline, and thus accelerate the decomposition of fat and energy consumption.

[0081] According to Traditional Chinese Medicine (TCM), the body's meridian system is the channel through which Qi and blood flow. Microcurrent stimulation can simulate this flow, promoting its smooth flow. When Qi and blood flow smoothly through the meridians, the body's metabolism is more normal, aiding in the metabolism and consumption of fat, while also improving overall health.

[0082] In summary, the present invention has the following beneficial effects: 1. Compared with traditional single-layer fat-reducing patches, the double-layer structure design of the present invention achieves the dual effects of fast-acting and sustained-release of drugs. The Chinese medicinal essential oil in the outer layer penetrates quickly, providing an immediate fat-reducing effect; the Chinese medicinal powder in the paste core layer continuously releases the drug ingredients to ensure long-lasting drug efficacy, which not only improves the utilization rate of the drug, but also enhances the stability of the fat-reducing effect. Different from conventional double-layer or multi-layer fat-reducing patches, the fat-reducing patch of the present invention directly uses the outer layer and the paste core layer to form a composite, without using a base fabric, which reduces the problems of poor air permeability and skin allergies caused by the base fabric in traditional fat-reducing patches, while increasing the contact area between the drug and the skin and enhancing the transdermal absorption efficiency of the drug. 2. In the formula of the fat-reducing patch of the present invention, the outer layer adopts a mixture of Chinese herbal essential oils, which contains 12 Chinese herbal ingredients such as Corydalis yanhusuo and Danshen, which have the effects of rapid penetration and improving blood circulation; the paste core layer contains 8 kinds of Chinese herbal powders such as Gynostemma pentaphyllum and Ginkgo biloba, combined with the microcurrent characteristics of ceramic clay, synergistically promote fat metabolism, not only enriching the drug ingredients, but also significantly improving the fat-reducing effect through the synergistic effect of Chinese herbal ingredients; the present invention organically combines Chinese herbal essential oils, Chinese herbal powders and ceramic clay, and the Chinese herbal essential oils penetrate quickly to improve local blood circulation; the Chinese herbal powders continuously release drug ingredients to regulate fat metabolism; the ceramic clay stimulates acupuncture points through microcurrent, enhancing drug absorption and meridian regulation function, and the three work synergistically to significantly improve the fat-reducing effect; the present invention adopts a double-layer structure design, combining the rapid penetration of Chinese herbal essential oils, the continuous release of Chinese herbal powders and microcurrent stimulation to form a triple fat-reducing mechanism of "quick effect-slow release-physical enhancement"; 3. The present invention adds silver nanoparticles to the core layer of the paste, which has antibacterial properties, effectively reduces the risk of skin infection, and enhances the conduction effect of microcurrent. The addition of menthol-glycerol solution to the outer layer not only enhances the transdermal absorption efficiency of the drug, but also improves the user's comfort through a cooling sensation and reduces skin irritation. 4. The fat-reducing patch preparation method of the present invention adopts a step-by-step heating and cooling mixing process, which is different from the traditional operation of melting and mixing the ingredients at a single temperature and then heating them up. It effectively protects the activity of the traditional Chinese medicine ingredients and avoids the damage of heat-sensitive and volatile components by high temperature. It not only improves the stability and uniformity of the medicine, but also optimizes the fluidity of the hot melt adhesive and the drug release efficiency, significantly improving the overall performance of the product. 5. The fat-reducing patch of the present invention is applied to the acupuncture points of the belt meridian on the abdomen or waist of the human body. Through the synergistic effect of microcurrent stimulation and traditional Chinese medicine ingredients, it regulates the meridians and blood, dredges the meridians, and promotes fat metabolism. It not only improves the targeted effect of fat reduction, but also combines the meridian theory of traditional Chinese medicine to provide a more scientific theoretical basis for fat reduction. DETAILED DESCRIPTION

[0083] This specific embodiment is merely an explanation of the present invention and is not intended to limit the present invention. After reading this specification, those skilled in the art may make non-creative modifications to this embodiment as needed. However, as long as such modifications are within the scope of the claims of the present invention, they are protected by patent law.

[0084] Example 1

[0085] S1 Preparation of outer layer: Heat black hot melt adhesive to 80°C to melt, cool to 65°C, add a mixture of Chinese herbal essential oils including 14 parts of Corydalis yanhusuo, 13 parts of salvia miltiorrhiza, 13 parts of safflower, 12 parts of bupleurum, 12 parts of ilex pubescens, 12 parts of prunella vulgaris, 12 parts of epimedium, 12 parts of kudzu root, 12 parts of cassia seed, 12 parts of rhubarb, 9 parts of raw hawthorn, and 9 parts of atractylodes, wherein the mass proportion of the Chinese herbal essential oil mixture is 3% of the total mass of the outer layer. After rapid stirring for 10 minutes to mix evenly, add menthol-glycerol solution in an amount of 5% of the total mass of the outer layer, continue stirring at 70°C for 3 minutes, and apply to form a film; Preparation of S2 paste core layer: heat the transparent hot melt adhesive to 80°C and melt it. Add Chinese herbal medicine powder including 20 parts of Gynostemma pentaphyllum, 20 parts of Ginkgo biloba leaves, 20 parts of Alisma orientalis, 20 parts of Polygonum cuspidatum, 13 parts of pomegranate leaves, 13 parts of cinnamon bark, 13 parts of cloves, and 13 parts of Alpinia officinalis and 8 parts of ceramic clay at 70°C. The weight proportion of the Chinese herbal medicine powder is 20% of the total weight of the paste core layer, and the weight proportion of the ceramic clay is 10% of the total weight of the paste core layer. Stir for 15 minutes to mix evenly. Slowly add silver nanoparticles with a weight proportion of 1.0% of the total weight of the paste core layer and continue stirring for 10 minutes. Apply to form a film. S3 Compounding and molding: Compound the prepared outer patch layer with the paste core layer, cut into patches, and complete the preparation of the fat reduction patch.

[0086] Example 2

[0087] The preparation of S1 outer layer is the same as that in Example 1; Preparation of S2 paste core layer: heat transparent hot melt adhesive to 70°C to melt, add Chinese herbal medicine powder including 10 parts of Gynostemma pentaphyllum, 10 parts of Ginkgo biloba leaves, 10 parts of Alisma orientalis, 10 parts of Polygonum cuspidatum, 7 parts of pomegranate leaves, 7 parts of cinnamon bark, 7 parts of cloves, and 7 parts of Alpinia officinalis and 2 parts of ceramic clay at 65°C, the mass proportion of Chinese herbal medicine powder is 10% of the total mass of the paste core layer, the mass proportion of ceramic clay is 1% of the total mass of the paste core layer, stir for 10 minutes to mix evenly, then slowly add silver nanoparticles accounting for 0.2% of the total mass of the paste core layer, continue stirring for 5 minutes, and apply to form a film; S3 compounding and molding are the same as in Example 1 to complete the preparation of the fat-reducing patch.

[0088] Example 3

[0089] S1 Preparation of outer layer: Heat black hot melt adhesive to 70°C to melt, cool to 60°C, add a mixture of Chinese herbal essential oils including 10 parts of Corydalis yanhusuo, 7 parts of Salvia miltiorrhiza, 7 parts of Carthamus tinctorius, 4 parts of Bupleurum chinense, 4 parts of Ilex pubescens, 4 parts of Prunella vulgaris, 4 parts of Epimedium, 4 parts of Pueraria lobata, 4 parts of Cassia seed, 4 parts of Rhubarb, 3 parts of Crataegus pinnatifida, and 3 parts of Atractylodes lancea, the mass proportion of the Chinese herbal essential oil mixture being 1% of the total mass of the outer layer. After rapid stirring for 5 minutes to mix evenly, add menthol-glycerol solution in an amount of 0.1% of the total mass of the outer layer, continue stirring at 60°C for 1 minute, and apply to form a film; The preparation of the S2 paste core layer and the S3 compounding and molding are the same as in Example 1 to complete the preparation of the fat-reducing patch.

[0090] Example 4

[0091] No menthol-glycerol solution was added to the preparation of the S1 outer layer. Other operations, the preparation of the S2 paste core layer, and the compounding and molding of S3 were the same as in Example 1.

[0092] Example 5

[0093] No silver nanoparticles were added to the preparation of the S2 paste core layer. Other operations, including the preparation of the S1 outer patch layer and the S3 compounding and molding were the same as in Example 1 to complete the preparation of the fat-reducing patch.

[0094] Comparative Example 1 S1 Hot melt adhesive melting: Take an appropriate amount of black hot melt adhesive and heat it to 75°C to make it completely melt and have good fluidity; S2 Traditional Chinese Medicine Essential Oil Mixing: Weigh the traditional Chinese medicine essential oil mixture according to the formula ratio as in Example 1, slowly add it to the molten hot melt adhesive at 65°C, and continue stirring for 8 minutes to ensure that the essential oil is evenly dispersed; S3 coating and molding: evenly apply the mixed paste on the release paper, peel it off after cooling and solidification, and cut it into the desired shape to complete the preparation of the fat reduction patch.

[0095] Comparative Example 2 S1 preparation of outer layer: same as Example 1 of the present invention; Preparation of the S2 paste core layer: Take an appropriate amount of transparent hot melt adhesive and heat it to 75°C to completely melt it and maintain good fluidity; weigh the Chinese medicinal powder according to the formula ratio of Example 1, add it to the molten hot melt adhesive at 68°C, and stir for 12 minutes to ensure that the ingredients are evenly dispersed. Do not add ceramic clay; evenly apply the mixed paste on the release paper, cool and solidify, peel it off, and cut it into the desired shape; S3 compounding and molding: compound the outer patch layer with the paste core layer, cut into patches, and complete the preparation of the fat reduction patch.

[0096] Comparative Example 3 S1. Preparation of the outer layer: Take an appropriate amount of black hot melt adhesive and heat it to 75°C to completely melt it and ensure good fluidity. Weigh the Chinese herbal essential oil mixture according to the formula ratio of Example 1 and add it directly to the molten hot melt adhesive at 75°C. Stir continuously for 8 minutes to ensure that the essential oil is evenly dispersed. Apply the mixed paste evenly on the release paper, cool and solidify it, peel it off, and cut it into the desired shape. Preparation of the S2 paste core layer: Take an appropriate amount of transparent hot melt adhesive and heat it to 75°C to completely melt it and maintain good fluidity. Weigh the Chinese medicine powder and ceramic clay according to the formula ratio, add them to the molten hot melt adhesive at 75°C, and stir for 12 minutes to ensure that the ingredients are evenly dispersed. Apply the mixed paste evenly on the release paper, cool and solidify, peel it off, and cut it into the desired shape. S3 compounding and molding: compound the outer patch layer with the paste core layer, cut into patches, and complete the preparation of the fat reduction patch.

[0097] 1. Performance testing The fat-reducing patches prepared in Examples 1-5 and Comparative Examples 1-3 were subjected to performance tests, including adhesion test, air permeability test, moisture permeability test, active ingredient release rate test, thermal stability test, storage period test, skin irritation test, microcurrent intensity and uniformity test, antibacterial test, and transdermal absorption rate test.

[0098] 1.1 Adhesion test Test method: Refer to the international standard ISO11193-1 "Test methods for pressure-sensitive tapes and adhesives" for testing. Cut a 25mm x 100mm sample from the fat-reducing patch and stick it to a clean skin surface (such as the inner forearm), ensuring there are no bubbles or wrinkles. Let it stand for 15 minutes to allow the adhesive to fully adhere to the skin. Use a standard adhesion tester to peel the fat-reducing patch from the skin at a speed of 300mm / min, and record the peel force (unit: Newton).

[0099] 1.2 Air and moisture permeability test Test Method: Refer to ASTM E96 "Standard Test Method for Water Vapor Transmission Rate" and ISO 7793 "Plastic Film and Sheeting - Determination of Water Vapor Transmission Rate" for testing. Cut a fat reduction patch sample with a diameter of 50mm and fix it in the test chamber of an air permeability tester. Set the test conditions to 23°C and 50% relative humidity. Record the gas transmission rate (unit: cm³ / m²·24h) over 24 hours. Fix the sample in the test chamber of a moisture permeability tester. Set the test conditions to 37°C and 100% relative humidity. Record the water vapor transmission rate (unit: g / m²·24h) over 24 hours.

[0100] 1.3 Active ingredient release rate test Test method: Refer to USP <724> The "Transdermal Drug Delivery System" was tested. A 1 cm² fat-reducing patch sample was cut out and fixed in the donor chamber of the Franz diffusion cell using a dynamic dialysis device. An appropriate amount of phosphate buffer solution with a pH of 7.4, which simulates the skin receiving fluid, was added. At 37°C ± 0.5°C, samples were taken at regular intervals (1, 2, 4, 8, 12, and 24 hours) to measure the concentration of the drug component in the receiving fluid, draw a drug release curve, and calculate the cumulative release amount and release rate.

[0101] 1.4 Thermal stability and storage period test Test method: Refer to ISO11607 "Packaging of terminally sterilized medical devices" and USP <661> The "Physical and Chemical Properties of Plastic Packaging Systems and Components" test was conducted. An appropriate amount of fat-reducing patch samples were taken and placed in a differential scanning calorimeter and a thermogravimetric analyzer. The temperature was raised from room temperature to 200°C at a heating rate of 10°C / min. The test was carried out under nitrogen protection to analyze the thermal decomposition temperature and thermal weight loss percentage of the samples. The samples were placed in an accelerated aging test at 40°C±2°C and 75%±5% relative humidity for 6 months, and the drug component retention rate and physical state were recorded.

[0102] 1.5 Skin irritation test Testing method: Refer to ISO10993-10 "Biological evaluation of medical devices" for testing. Take an appropriate amount of fat-reducing patch sample and apply it to the inner forearm of a volunteer. The application area of ​​each sample is 2 cm². The application time is 24 hours. The skin reaction is observed 24 hours, 48 ​​hours, and 72 hours after application. Irritation symptoms such as erythema, edema, and itching are recorded. According to the skin reaction scoring standard (0 points: no reaction; 1 point: mild erythema; 2 points: moderate erythema; 3 points: severe erythema; 4 points: edema, etc.), a total score of ≤2 points indicates no irritation, 3-6 points indicates mild irritation, and ≥7 points indicates moderate or severe irritation. An overall score is given for the skin irritation of each sample.

[0103] 1.6 Microcurrent intensity and uniformity test Testing method: Refer to IEC60601-2-10 "Medical Electrical Equipment" for testing. Take an appropriate amount of fat reduction patch sample, apply the sample to gauze soaked in conductive saline, and connect it to a microcurrent tester. Under simulated skin conditions (37°C, 90% humidity), record the intensity and distribution of the microcurrent.

[0104] 1.7 Antibacterial performance test Test method: Refer to ISO20743 "Determination of antibacterial properties" for testing. Take an appropriate amount of fat reduction patch sample, cut the sample into 1cm² small pieces, and place it in a container containing 10 6The culture medium was incubated at 37°C for 24 hours with 0.1 CFU / mL of Staphylococcus aureus or Escherichia coli. Samples were taken for colony count to calculate the inhibition rate and record the comprehensive inhibition rate.

[0105] 1.8 Transdermal absorption rate test Test method: Refer to USP <724> The "Transdermal Drug Delivery System" was tested. A 1 cm² fat-reducing patch sample was cut out and fixed in the donor chamber of a Franz diffusion cell. An appropriate amount of receiving solution (pH 7.4 phosphate buffer) was added. At 37°C ± 0.5°C, samples were taken at regular intervals (e.g., 1, 2, 4, 8, 12, 24 hours). The concentrations of various drug components in the receiving solution were measured, and the comprehensive transdermal absorption rate of the various components was calculated (unit: µg / cm²·h).

[0106] 2. Test results Table 1 Summary of performance test results of various fat reduction patches

[0107] Result analysis: In the adhesion test, the average peel force of Examples 1-5 was between 0.50-0.65N, and that of Comparative Examples 1-3 was between 0.42-0.48N. The adhesion of the examples was better than that of the comparative examples as a whole, especially Example 1 had the highest peel force (0.65N), indicating that its adhesion performance was good, which was related to the double-layer structure design and the optimization of the ingredients; while the adhesion of Comparative Example 1 (single-layer structure) and Comparative Example 3 (no step-by-step heating) was relatively poor, indicating that the double-layer structure design (outer patch layer and paste core layer) and the specific preparation process (such as step-by-step heating, addition of menthol-glycerol solution, etc.) in the examples enhanced the performance of the adhesive, indicating that the preparation process and component composition of the present invention enable the fat-reducing patch to better fit the skin and be less likely to fall off, which is conducive to the continued effect of the drug on the skin.

[0108] In terms of air permeability (gas permeability), the values ​​of Examples 1-5 are 520-610 cm³ / m²・24h, and those of Comparative Examples 1-3 are 420-480 cm³ / m²・24h; in terms of moisture permeability (water vapor permeability), the values ​​of the Examples are 5100-5500 g / m²・24h, and those of the Comparative Examples are 4700-4900 g / m²・24h; the air permeability and moisture permeability of the Examples are better than those of the Comparative Examples, while the air permeability and moisture permeability of Comparative Example 2 (without ceramic clay) are poor, indicating that the addition of ceramic clay helps to improve these two properties. The ceramic clay and silver nanoparticles added in the Examples improve the pore structure of the patch, so that the fat-reducing patch of the present invention can better ensure the respiration and water metabolism of the skin, improve the comfort of use, and reduce the adverse reactions of the skin caused by airtightness and moisture.

[0109] From the perspective of the active ingredient release rate at each time point and the cumulative release amount over 24 hours, the examples are generally higher than the comparative examples. For example, at 1 hour, the release rate of the examples is 4.0-5.5µg / cm²·h, while that of the comparative example is 2.5-3.5µg / cm²·h. The cumulative release amount over 24 hours is 70-85µg / cm² for the examples, while that of the comparative example is 45-55µg / cm². This shows that the preparation process of the examples (such as step-by-step heating and the addition of menthol-glycerol solution) helps to improve the release efficiency of the active ingredients and provide a stronger guarantee for the fat-reducing effect.

[0110] In terms of thermal decomposition temperature, Examples 1-5 are at 175-182°C, while Comparative Examples 1-3 are at 158-165°C; the percentage of thermal weight loss in the Examples is 4-7%, while that in the Comparative Examples is 10-14%; the 6-month drug ingredient retention rate in the Examples is 92-96%, while that in the Comparative Examples is 78-82%; this indicates that the ingredients such as ceramic clay and silver nanoparticles added in the Examples improve the thermal stability and chemical stability of the patch, and the thermal stability and shelf life of the Examples are significantly better than those of the Comparative Examples, indicating that they can better maintain the stability of the drug ingredients under high temperature and long-term storage conditions; while the thermal stability and shelf life of Comparative Example 3 (without step-by-step heating) are poor, indicating that the step-by-step heating process helps to improve the stability of the product; the Examples have better thermal stability, less loss of drug ingredients during storage, and a more stable physical state, thereby extending the shelf life of the product and facilitating long-term storage and quality stability of the product.

[0111] The skin irritation scores of the embodiments were between 1-1.8, indicating that they were non-irritating or mildly irritating. The scores of the comparative examples were between 2.5-3.0. Their single-layer structure or lack of specific ingredients (such as ceramic clay and menthol-glycerin solution) resulted in poor skin adaptability and relatively high irritation. This indicates that the fat-reducing patch of the present invention performs better in terms of skin irritation, is safer to use, and can reduce the risk of skin discomfort for users.

[0112] In terms of microcurrent intensity, the embodiment is 0.15-0.35mA, and the comparative example is 0.01-0.08mA; the distribution uniformity of the embodiment is 6-9%, and that of the comparative example is 12-15%. Although the distribution uniformity value of the comparative example seems to be higher, the microcurrent intensity is too low. The embodiment can maintain better uniformity while ensuring a certain intensity, which is more conducive to promoting fat loss through microcurrent stimulation of acupuncture points. The silver nanoparticles added in the embodiment can enhance the generation and distribution of microcurrent, thereby helping to promote the transdermal absorption of drug ingredients.

[0113] In the antibacterial performance test, the antibacterial rate of the embodiment was between 91% and 95%, and the antibacterial rate of the comparative example was between 82% and 88%. The antibacterial performance of the embodiments was better than that of the comparative example, especially the antibacterial rates of Examples 1 and 5 were higher, indicating that the addition of silver nanoparticles had a significant improvement in the antibacterial performance; the transdermal absorption rate of the embodiment was 10-12µg / cm²·h, and that of the comparative example was 7-9µg / cm²·h. The transdermal absorption rate of the embodiment was significantly higher than that of the comparative example, indicating that its formula and preparation process were more conducive to the transdermal absorption of the drug ingredients; the antibacterial performance and transdermal absorption rate of the embodiment were better than those of the comparative example. Good antibacterial performance can reduce the risk of skin infection, and a high transdermal absorption rate can enable more drug ingredients to enter the human body to take effect, thereby enhancing the fat reduction effect.

[0114] Based on the summary data of the performance test results of various fat-reducing patches, the fat-reducing patches prepared in the embodiments of the present invention are generally superior to the comparative examples in various performance aspects, and show obvious advantages in adhesion, breathability, active ingredient release, thermal stability, skin irritation, antibacterial and transdermal absorption rate. The optimization of these properties helps to improve the effectiveness and practicality of the fat-reducing patch.

[0115] 2. Effect verification In order to verify the actual fat-reducing effect of the fat-reducing patch of the present invention, a 7-day clinical trial was designed and 23 volunteers (including men and women) were recruited. All participants underwent a detailed health check before the trial to ensure that they were suitable for participation in the trial. Before the start of the trial, the height, weight and waist circumference of each participant were recorded as baseline data. Each participant used a fat-reducing patch of the present invention every day, applied it to the belt meridian acupoints on the abdomen or waist, and changed it once a day for 7 consecutive days. After the trial, the weight and waist circumference of each participant were measured again, and the changes in weight and waist circumference were calculated. The fat-reducing effect of the fat-reducing patch was evaluated by comparing the weight and waist circumference data before and after use. All data were analyzed using scientific statistical methods to ensure the reliability and validity of the results.

[0116] Table 2 Comparison of weight and waist circumference changes before and after using the fat-reducing patch

[0117] Result analysis: During the 7-day trial, the weight of all 23 volunteers decreased, with the weight change range being between -0.2kg and -2.5kg, and the waist circumference change range being between -0.2cm and -4.0cm. The average weight decreased by about 1.39kg, and the average waist circumference decreased by about 1.74cm. This shows that the fat-reducing patch has a good effect on reducing waist circumference and losing weight, proving the effectiveness and practicality of the fat-reducing patch of the present invention.

[0118] The present invention provides a double-layer fat-reducing patch comprising an outer layer and a core layer, and its preparation method. The outer layer is made from 12 natural Chinese herbal essential oils and black hot-melt adhesive, utilizing small molecules to rapidly penetrate the skin. The core layer contains eight Chinese herbal powders, transparent hot-melt adhesive, and ceramic clay, generating microcurrents to stimulate the acupuncture points of the Dai Meridian and accelerate drug absorption. The preparation method encompasses melt mixing, coating, molding, and compounding processes. Through its innovative double-layer structure, optimized Chinese herbal formula, and microcurrent stimulation technology, this fat-reducing patch addresses the issues of poor effectiveness, low safety, and complex operation associated with existing weight loss methods and patches. Clinical trials have demonstrated significant results in reducing waist circumference and weight, providing a safe, effective, and convenient new topical solution for weight loss.

Claims

1. A fat-reducing patch, characterized in that: The invention comprises an outer layer and a core layer, wherein the outer layer comprises a black hot melt adhesive matrix and a mixture of Chinese herbal essential oils, wherein the mixture of Chinese herbal essential oils comprises, by weight, 10-14 parts of Corydalis yanhusuo, 7-13 parts of Salvia miltiorrhiza, 7-13 parts of Carthamus tinctorius, 4-12 parts of Bupleurum chinense, 4-12 parts of Ilex pubescens, 4-12 parts of Prunella vulgaris, 4-12 parts of Epimedium, 4-12 parts of Pueraria root, 4-12 parts of Cassia seed, 4-12 parts of Rhubarb, 3 -9 parts of raw hawthorn, 3-9 parts of atractylodes; the paste core layer includes a transparent hot-melt adhesive matrix, Chinese medicine powder and ceramic clay, the Chinese medicine powder includes, by mass: 10-20 parts of Gynostemma pentaphyllum, 10-20 parts of Ginkgo biloba leaves, 10-20 parts of Alisma orientalis, 10-20 parts of Polygonum cuspidatum, 7-13 parts of pomegranate leaves, 7-13 parts of cinnamon, 7-13 parts of cloves, 7-13 parts of galangal, and the mass portion of the ceramic clay is 2-8 parts.

2. The fat-reducing patch according to claim 1, characterized in that: In the outer layer, the mass proportion of the Chinese medicine essential oil mixture is 1-3% of the total mass of the outer layer; in the core paste layer, the mass proportion of Chinese medicine powder is 10%-20% of the total mass of the core paste layer, and the mass proportion of ceramic clay is 1%-10% of the total mass of the core paste layer.

3. A method for preparing a fat-reducing patch, characterized in that: The following steps are involved: S1 Preparation of outer layer: Heat black hot melt adhesive until molten, add a mixture of Chinese herbal essential oils including 10-14 parts of Corydalis yanhusuo, 7-13 parts of salvia miltiorrhiza, 7-13 parts of safflower, 4-12 parts of bupleurum, 4-12 parts of ilex pubescens, 4-12 parts of prunella vulgaris, 4-12 parts of epimedium, 4-12 parts of kudzu root, 4-12 parts of cassia seed, 4-12 parts of rhubarb, 3-9 parts of raw hawthorn, and 3-9 parts of atractylodes, stir quickly and evenly, and then apply to form a film, wherein the weight of the Chinese herbal essential oil mixture accounts for 1%-3% of the total weight of the outer layer; S2 Preparation of the paste core layer: Heat the transparent hot melt adhesive to a molten state, add 10-20 parts of Chinese herbal medicine powder including Gynostemma pentaphyllum, 10-20 parts of Ginkgo biloba leaves, 10-20 parts of Alisma orientalis, 10-20 parts of Polygonum cuspidatum, 7-13 parts of pomegranate leaves, 7-13 parts of cinnamon bark, 7-13 parts of cloves, 7-13 parts of galangal, and 2-8 parts of ceramic clay, mix well, and apply to form a film, wherein the weight of the Chinese herbal medicine powder accounts for 10%-20% of the total weight of the paste core layer, and the weight of the ceramic clay accounts for 1%-10% of the total weight of the paste core layer; S3 Compounding and molding: Compound the prepared outer patch layer with the paste core layer, cut into patches, and complete the preparation of the fat reduction patch.

4. The method for preparing the fat-reducing patch according to claim 3, wherein: The preparation of the outer layer specifically includes the following steps: S11 Hot melt adhesive melting: Heat the black hot melt adhesive to 70℃-80℃ to make it completely melt and have good fluidity; S12 Traditional Chinese Medicine Essential Oil Mixing: Weigh a mixture of 12 traditional Chinese medicine essential oils, including Corydalis yanhusuo, Danshen, and Safflower, according to the formula ratio; slowly add the traditional Chinese medicine essential oil mixture to the molten hot melt adhesive at 60-70°C, and continue stirring for 5-10 minutes to ensure that the essential oils are evenly dispersed; S13 coating and molding: evenly apply the mixed paste on the release paper, peel it off after cooling and solidification, and cut it into the desired shape.

5. The method for preparing the fat-reducing patch according to claim 4, characterized in that: The preparation of the outer layer also includes the following operations: adding menthol to glycerol preheated to 40°C-50°C, where the mass of glycerol is 2-10 times that of menthol, stirring evenly to form a menthol-glycerol solution, then adding it to the mixed system of black hot melt adhesive and traditional Chinese medicine essential oil, and continuing to stir at 60°C-70°C for 1-3 minutes to ensure that the menthol and glycerol are evenly dispersed and fully mixed with other ingredients; the amount of the menthol-glycerol solution used is 0.1%-5% of the total mass of the outer layer.

6. The method for preparing the fat-reducing patch according to claim 3, characterized in that: The preparation of the paste core layer specifically includes the following steps: Melting of S21 hot melt adhesive: Heat the transparent hot melt adhesive to 70℃-80℃ to completely melt it and maintain good fluidity, while stirring continuously to prevent caking; S22 Mixing: Add the mixed Chinese medicine powder and ceramic clay to the molten hot melt adhesive in proportion at 60-70°C, and stir for 10-15 minutes to ensure that the ingredients are evenly dispersed; S23 coating and molding: evenly apply the mixed paste on the release paper, peel it off after cooling and solidification, and cut it into the desired shape.

7. The method for preparing the fat-reducing patch according to claim 6, characterized in that: The preparation of the paste core layer specifically includes the following operations: slowly adding silver nanoparticles accounting for 0.2%-1.0% of the total mass of the paste core layer to a transparent hot melt adhesive system that has been mixed with traditional Chinese medicine powder and ceramic clay, continuing to stir for 5-10 minutes to ensure that the silver nanoparticles are evenly dispersed before continuing coating and forming.

8. The method for preparing the fat-reducing patch according to claim 4 or 6, characterized in that: The heating is step-by-step heating, specifically including preliminary melting and cooling and mixing; the preliminary melting includes: heating the hot melt adhesive to 70°C-80°C so that it is initially melted at high temperature and has a certain fluidity; the cooling and mixing includes: after lowering the temperature to 60°C-70°C, adding a mixture of Chinese herbal essential oils or Chinese herbal powder and ceramic clay for mixing, wherein when preparing the outer layer, the temperature is lowered to 60°C-65°C before the Chinese herbal essential oil mixture is added for mixing, and when preparing the paste core layer, the temperature is lowered to 65°C-70°C before the Chinese herbal powder and ceramic clay are added for mixing.

9. The method for preparing the fat-reducing patch according to claim 3, characterized in that: The compounding and molding specifically include the following operations: spreading the paste core layer on the release paper, covering the outer patch layer and compacting it to expel bubbles, cooling it naturally or accelerating cooling to solidify it into shape, and then cutting it into the desired shape to complete the preparation of the fat reduction patch.

10. The fat-reducing patch according to claim 1, characterized in that: When used, it is applied to the abdomen or waist area of ​​the human body, preferably to the belt meridian acupoints, and achieves fat reduction effects through the double-layer structure of drug action and microcurrent stimulation.

Images