External patch containing extract of smallflower curcuma (black ginger) and method of making same

Abstract

This invention discloses a topical patch containing Kaempferia galanga (black ginger) extract and its preparation method. The patch comprises, from the outside in, a non-woven fabric backing layer, a heating pack, a breathable and leak-proof membrane, a plaster layer, and a release liner. The heating pack provides continuous, gentle heat to promote transdermal drug absorption. The plaster layer contains Kaempferia galanga extract and various traditional Chinese medicine extracts. The abdominal patch contains Kaempferia galanga (black ginger), Garcinia cambogia, and Atractylodes lancea, used to improve abdominal metabolism and promote bowel movement; the waist patch focuses on regulating blood circulation in the abdomen; the leg patch contains Kaempferia galanga (black ginger), Clematis chinensis, Clematis armandii, and Achyranthes bidentata, suitable for leg soreness and poor circulation; the arm patch contains Kaempferia galanga (black ginger), Curcuma longa, Luffa cylindrica, and Luffa cylindrica, specifically improving arm metabolism. This invention solves the problems of insufficient penetration and slow onset of action in traditional black ginger topical applications, as well as the skin irritation and easy fall-off of traditional plasters, achieving gentle, convenient, and efficient local metabolic regulation and shaping.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and in particular to a topical patch containing extracts of Kaempferia galanga (black ginger) and its preparation method, which is especially suitable for local metabolic conditioning and shaping needs of the waist, abdomen, legs, arms, etc., achieving the effect of gentle external application and convenient conditioning. Background Technology

[0002] Kaempferia parviflora, commonly known as black ginger, black-fleshed ginger, or Thai black ginger, is a perennial herbaceous plant belonging to the genus Kaempferia in the ginger family (Zingiberaceae). It is not a black variant of common ginger, nor is it a special processed variety of ginger used in traditional Chinese medicine. Rather, it is an independent species with unique genetic characteristics and medicinal value. Native to tropical Southeast Asia, it has a long history of traditional use in countries such as Thailand and Laos. Later, it was introduced and cultivated in parts of southern and southwestern my country. It is named "black ginger" because its rhizomes are dark brown to nearly black.

[0003] In traditional applications, the dried rhizome of *Kaempferia galanga* is the core medicinal part. Traditional Chinese medicine believes it is pungent and warm in nature, enters the stomach meridian, and has the effects of warming the middle jiao (spleen and stomach), dispelling cold, promoting qi circulation, relieving pain, and aiding digestion. However, modern scientific theories, supported by numerous domestic and international papers, have demonstrated that *Kaempferia galanga* is rich in 5,7-dimethoxyflavonoids (DMF), which have significant fat-burning effects. This black ginger slimming patch bridges the gap between traditional external application techniques (plasters) and modern science, delivering the traditional medicinal effects directly to the affected area.

[0004] Although the medicinal value of *Kaempferia galanga* is widely recognized, its application in China is currently limited to ethnic minorities in Yunnan Province, primarily using powdered roots applied topically. Other mature product forms are lacking in other fields or modern products. These traditional applications (such as direct powdering for external application or decoction) have significant limitations: First, drug penetration is severely insufficient, making it difficult for active ingredients to penetrate the skin barrier and reach deep target tissues, resulting in slow onset of action and extremely low bioavailability; second, component stability is poor, with the raw powder easily deactivated by environmental influences and release uncontrollable; third, the user experience is unpleasant, with powder easily spilling, staining clothing, and lacking skin gentleness assurance. Furthermore, its exclusion from my country's list of medicinal and edible substances restricts its direct application in the domestic pharmaceutical, health product, and food sectors. Therefore, promoting its compliant transformation into medical devices (external patches) is a crucial direction for expanding its application scenarios.

[0005] In the field of topical patches, traditional plasters (such as rubber plasters and poultices) are widely used, but they generally have many drawbacks: 1. Irritation and allergies: Commonly used transdermal penetration enhancers or matrix ingredients can easily cause allergic reactions such as skin redness, swelling, and itching; 2. Poor adhesion and comfort: The plaster is easy to slip off, especially on active areas such as joints or the abdomen, and the backing is not breathable, which can easily cause a stuffy feeling; 3. Single function: It is only a drug carrier and lacks the synergy of physical therapy; 4. Insufficient targeting: It is difficult to adapt to specific needs such as abdominal obesity and poor local metabolism, and cannot achieve synergistic conditioning of warming, fat reduction, and bowel movement; 5. Poor formulation synergy: It lacks precise compatibility for local metabolic conditioning and cannot fundamentally improve problems such as obesity recurrence and edema.

[0006] In recent years, although there have been attempts to combine heat therapy with drug therapy (such as attaching heat packs to the outside of plasters), simple layering has fundamental flaws: 1. Misalignment between heat source and drug effect area: It is difficult for the two to overlap precisely and for a long time, resulting in wasted heat energy or no drug effect in the heat-treated area; 2. Uncontrollable temperature and unsafe: The heat pack is directly exposed to the air, and the heat is unstable, posing a risk of burns; 3. Cumbersome to use and cumbersome experience: Multiple layers are not only troublesome, but also thick and do not fit well, affecting daily activities.

[0007] For localized conditioning needs such as the waist and abdomen, existing products still have the following shortcomings: they cannot meet the multi-dimensional needs of "warming metabolism, fat reduction and shaping, and promoting qi circulation and bowel movement". Some products only focus on surface fat reduction and ignore the improvement of the internal metabolic environment, resulting in repeated effects; they are not convenient to use and are difficult to adapt to home or invisible usage scenarios; some products are too irritating and are not suitable for long-term patch conditioning. Summary of the Invention

[0008] The technical problem to be solved by this invention is to overcome the shortcomings of the prior art and provide a topical patch containing Kaempferia galanga (black ginger) extract and its preparation method. It aims to solve the problems of insufficient penetration, slow onset of action, poor stability of active ingredients, and inability to penetrate into effective parts of the body by traditional black ginger topical application. At the same time, it improves the user experience and safety of black ginger ingredients and solves the problems of traditional plasters such as "irritating the skin and causing allergies" and "not adhering well and falling off easily", so as to achieve gentle, convenient and efficient local metabolic conditioning and shaping.

[0009] In order to achieve the above-mentioned objectives, the first aspect of the present invention proposes a topical patch containing extract of Kaempferia galanga (black ginger) and its preparation method, comprising a non-woven fabric backing layer, a heating pack, a breathable and leak-proof membrane, a plaster layer and a release liner layer stacked sequentially from the outside to the inside; The heating pack is fixedly installed on the inner side of the non-woven fabric backing layer. The breathable and leak-proof membrane covers the inside of the heating pack and physically isolates it from the plaster layer, and the periphery of the breathable and leak-proof membrane is sealed to the non-woven fabric backing layer. The plaster layer is applied to the inner surface of the breathable and leak-proof membrane and contains galangal (black ginger) extract. The heating pack contains a heating composition that can undergo an exothermic oxidation reaction after coming into contact with the air that passes through the nonwoven backing layer and the breathable and leak-proof membrane.

[0010] Optionally, the heating composition includes iron powder, activated carbon, vermiculite, salt and water, with a heating temperature of 40℃–55℃ and a continuous heating time of 3–12 hours. The abdominal patch (butterfly patch) is suitable for 3-hour application, taking into account both the warming effect and skin tolerance.

[0011] Optionally, the plaster layer is made of a mixture of medical pressure-sensitive adhesive and traditional Chinese medicine extract, wherein the mass percentage of Kaempferia galanga (black ginger) extract in the plaster layer is 5-10%, and the medical pressure-sensitive adhesive is mild and non-irritating, suitable for long-term external use.

[0012] Optionally, the herbal extract is based on the extract of *Kaempferia galanga* (black ginger), and is combined with extracts from at least the following herbs: Garcinia cambogia, Atractylodes lancea, Magnolia officinalis, Citrus aurantium, Morus alba root bark, Tetrandra chinensis, Eupatorium fortunei, Cinnamomum cassia, Menthol, Salvia miltiorrhiza, Crataegus pinnatifida (roasted), Alisma plantago-aquatica, Poria cocos, Coix lacryma-jobi, Citrus reticulata peel, Aesculus hippocastanum, Spatholobus suberectus, Ophiopogon japonicus, Liquidambar formosana, Achyranthes bidentata, Clematis chinensis, Astragalus membranaceus, Lycopus lucidus, Caulis Scutellariae, Ligusticum chuanxiong, and Schisandra chinensis. This forms a three-dimensional conditioning system of "warming-dispelling-unblocking": *Kaempferia galanga* (black ginger) and Atractylodes lancea warm and dispel cold and dampness, and enhance local metabolism; Garcinia cambogia and Crataegus pinnatifida (roasted) assist in regulating fat metabolism; Magnolia officinalis, Citrus aurantium, and Citrus reticulata promote qi circulation and unblock the bowels, improve abdominal distension and constipation, and improve the local metabolic environment from the root.

[0013] Optionally, the breathable and leak-proof membrane is a polyethylene membrane with a microporous structure, which can ensure that the heat generated by the heating pack is evenly conducted to the skin, promote the transdermal absorption of active ingredients, and prevent the leakage of the plaster layer ingredients, thereby improving the user experience.

[0014] Optionally, the nonwoven backing layer is made of medical-grade nonwoven fabric, which has good breathability and reduces stuffiness; the release liner is made of glassine release paper, which is easy to tear and is suitable for single-use scenarios.

[0015] Optionally, the patch is an abdominal patch (butterfly patch), waist patch, leg patch, or arm patch, precisely formulated to meet the needs of different body parts: Among them, when the patch is an abdominal patch (butterfly patch), it is suitable for people who sit for long periods of time and have abdominal obesity, postpartum looseness, and edema due to bloating. The plaster layer contains extracts of small-flowered galangal (black ginger), Garcinia cambogia, Atractylodes lancea, Salvia miltiorrhiza, Magnolia officinalis, Aesculus hippocastanum, Crataegus pinnatifida, Spatholobus suberectus, Citrus aurantium, Ophiopogon japonicus, Schisandra chinensis, Alisma plantago-aquatica, Poria cocos, Coix lacryma-jobi, and Citrus reticulata. It can clear the intestines, drain edema, improve the metabolic environment of the waist and abdomen, and systematically dismantle the root cause of bloating in the waist and abdomen. When the patch is a waist patch, the plaster layer contains extracts of Kaempferia galanga (black ginger), Garcinia cambogia, Atractylodes lancea, Magnolia officinalis, Salvia miltiorrhiza, Citrus aurantium, Morus alba root bark, Tetrapanax papyriferus, Eupatorium fortunei, and Cinnamomum cassia, which focus on regulating blood circulation in the waist and abdomen and are suitable for people with obvious waist and abdominal fat and poor circulation. When the patch is a leg patch, the plaster layer contains extracts of Kaempferia galanga (black ginger), horse chestnut, Clematis chinensis, Clematis armandii, Cinnamomum cassia, Astragalus membranaceus, Ligusticum chuanxiong, Poria cocos, Lycopus lucidus, and Achyranthes bidentata, suitable for people with leg soreness, poor circulation, and local fat accumulation. When the patch is an arm patch, the plaster layer contains extracts of Kaempferia galanga (black ginger), horse chestnut, Pterocarya stenoptera, Smilax china, Salvia miltiorrhiza, Cinnamomum cassia, Curcuma longa, Luffa cylindrica, and Luffa cylindrica, which specifically improve arm metabolism and meet the needs of arm contouring.

[0016] The second aspect of this invention provides a method for preparing a topical patch containing extracts of Kaempferia galanga (black ginger), comprising the following steps: S1: Provide a non-woven fabric backing layer; S2: A heating pack is fixedly installed on the inner side of the non-woven fabric backing layer; S3: Cover the inside of the heating pack with a breathable and leak-proof membrane, and seal the periphery of the breathable and leak-proof membrane with the non-woven fabric backing layer, so that the heating pack is encapsulated between the non-woven fabric backing layer and the breathable and leak-proof membrane. S4: A plaster layer containing Kaempferia galanga (black ginger) extract is coated on the inner surface of the breathable and leak-proof membrane. The coating thickness is 0.1–0.3 mm. Menthol is added to the plaster layer to neutralize the irritation and enhance the cool and refreshing user experience. S5: Cover the outside of the plaster layer with release paper.

[0017] S6: The prepared patches are individually packaged in aluminum-plastic composite film sealed bags to ensure product stability and suitability for convenient home use.

[0018] Optionally, the preparation of the traditional Chinese medicine extract in step S4 adopts a water decoction or ethanol reflux extraction process to ensure the efficient retention of active ingredients such as Kaempferia galanga (black ginger) extract and Garcinia cambogia extract, and improve transdermal absorption efficiency.

[0019] The beneficial effects of this invention are: 1. The present invention relates to a topical patch containing Kaempferia galanga (black ginger) extract and its preparation method. By integrating a controllable and gentle heating pack with a medicated plaster layer through a breathable and leak-proof membrane, the continuous low-temperature heat generated by the heating pack provides a dual effect on the application site: on the one hand, it directly promotes local capillary dilation and accelerates blood circulation, which is beneficial for the dissipation of inflammatory mediators and creates a blood-rich environment for drug absorption; on the other hand, the heat reversibly increases the lipid fluidity of the stratum corneum, widens the intercellular spaces, and significantly reduces the transdermal resistance of the drug. This significantly improves the transdermal absorption rate and total absorption of Kaempferia galanga (black ginger) extract and other active ingredients of traditional Chinese medicine, solving the problems of slow onset and weak efficacy of traditional topical products.

[0020] 2. The topical patch containing Kaempferia galanga (black ginger) extract of the present invention and its preparation method, through the laminated structure of a non-woven fabric backing layer, a heating pack, a breathable and leak-proof membrane, and a plaster layer, ensure 100% spatial overlap and temporal synchronization between the heating area and the drug delivery area. Heat is strictly limited to the lesion or acupoint area covered by the plaster, avoiding the heat scattering waste of traditional methods, achieving precise targeted treatment where the medicine and heat are precisely applied, significantly enhancing the purposefulness and efficiency of treatment.

[0021] 3. The topical patch containing Kaempferia galanga (black ginger) extract and its preparation method of the present invention, through an integrated multi-layer composite structure, resolves multiple contradictions regarding safety, stability, and ease of use. The heating pack is sealed between the backing layer and the breathable leak-proof membrane. Its reaction rate with oxygen is physically regulated by the microporous structure of the breathable membrane, thereby obtaining a stable and long-lasting heating curve and eliminating the risk of sudden temperature rises and falls. The leak-proof membrane completely isolates the heating material from contact with the skin and the drug layer, preventing leakage, contamination, and potential irritation. Furthermore, the vacuum-sealed packaging with the aluminum-plastic composite film ensures that the heating pack does not come into contact with air and become ineffective during storage and transportation, while protecting the stability of the heat-sensitive Chinese herbal ingredients in the plaster layer.

[0022] 4. The topical patch containing Kaempferia galanga (black ginger) extract and its preparation method of the present invention allow users to simultaneously receive heat therapy and drug therapy simply by "tearing and applying," making the operation extremely convenient. The integrated design makes the product thinner and more conforms to the body's curves, solving the problems of bulkiness, bloating, and easy shifting associated with traditional layering methods. The non-woven fabric backing layer also provides excellent breathability, significantly improving user compliance and comfort.

[0023] 5. The external patch containing Kaempferia galanga (black ginger) extract and its preparation method of the present invention are designed with exclusive formulas for the conditioning needs of different parts such as the abdomen, waist, legs, and arms. For example, the waist patch is combined with Garcinia cambogia, Atractylodes lancea, Magnolia officinalis, etc., focusing on regulating the blood circulation of the waist and abdomen, suitable for people with obvious waist and abdomen fat and poor circulation, and suitable for waist and abdomen shaping; the leg patch is combined with Clematis chinensis, Clematis armandii, Achyranthes bidentata, etc., focusing on dispelling wind and dampness, promoting blood circulation and unblocking collaterals, suitable for leg soreness, poor circulation, and local fat accumulation; the arm patch is combined with Curcuma longa, Luffa cylindrica, Luffa cylindrica, etc., focusing on dispersing blood stasis and relieving pain, unblocking collaterals and improving arm metabolism, suitable for arm line conditioning needs. Among them, the abdominal patch (butterfly patch) is specifically designed for people who are overweight due to prolonged sitting, postpartum sagging, or edema. It uses a precisely proportioned compound of ingredients such as galangal (black ginger), Garcinia cambogia, and Atractylodes lancea to promote bowel movement, reduce edema, improve the metabolic environment of the waist and abdomen, and address issues such as localized fat accumulation and loose skin, thus meeting diverse health conditioning needs across multiple scenarios. This allows the same product structure to precisely meet the diverse health needs of multiple areas such as the waist, abdomen, legs, and arms, demonstrating a high degree of design flexibility and market adaptability. Attached Figure Description

[0024] Figure 1 This is a schematic diagram of the external patch containing the extract of Kaempferia galanga (black ginger) of the present invention; Figure 2 This is a schematic flowchart illustrating the preparation method of the topical patch containing Kaempferia galanga (black ginger) extract according to the present invention.

[0025] Explanation of reference numerals in the attached figures: 1. Non-woven fabric backing layer; 2. Heating pack; 3. Breathable and leak-proof membrane; 4. Plaster layer; 5. Release liner.

[0026] The realization of the objective, functional features and advantages of the present invention will be further explained in conjunction with the embodiments and with reference to the accompanying drawings. Detailed Implementation

[0027] It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0028] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "joining" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection, a direct connection, or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0029] Example 1: Basic type waist and abdomen patch Reference Figures 1-2 An embodiment of the present invention provides a topical patch containing extract of Kaempferia galanga (black ginger), the structure of which, from the outside to the inside, includes: a non-woven fabric backing layer 1, a heating pack 2, a breathable and leak-proof membrane 3, a plaster layer 4, and a release liner 5.

[0030] The structural parameters for each layer are as follows: The non-woven backing layer 1 is made of medical-grade non-woven fabric, preferably 10cm×12cm in size and 0.3mm in thickness.

[0031] The heating pack 2 is preferably 6cm × 8cm in size and is fixed to the center of the inner side of the non-woven fabric backing layer 1. It contains a heating composition consisting of 30g iron powder, 5g activated carbon, 10g vermiculite, 2g sodium chloride, and 8g water. The heating temperature of the heating pack 2 is 45℃ ± 5℃, and the heating time is 8 hours.

[0032] The breathable and leak-proof membrane 3 is a polyethylene membrane with a microporous structure, a thickness of 0.05 mm, and a size slightly larger than the heating pack 2. It is sealed and connected to the non-woven fabric backing layer 1 around the perimeter with medical pressure-sensitive adhesive.

[0033] The plaster layer 4 is coated on the inner side of the breathable and leak-proof membrane 3, with a thickness of 0.2 mm. It is made by mixing medical pressure-sensitive adhesive and traditional Chinese medicine extract at a mass ratio of 3:1. The extract of small-flowered galangal (black ginger) accounts for 8%, and the remainder is matrix excipients.

[0034] Release paper 5 is made of glassine release paper and is used to cover the outside of the plaster layer 4.

[0035] The preparation method of the topical patch containing Kaempferia galanga (black ginger) extract is as follows: Step S1: Prepare nonwoven backing layer 1. Take medical-grade spunlace nonwoven fabric and cut it into a rectangular sheet of 10cm×12cm with a thickness of 0.3mm. This sheet will serve as nonwoven backing layer 1 for later use.

[0036] Step S2: Preparation and fixation of the heating pack 2: (1) Preparation of heating composition: Weigh 30g of iron powder, 5g of activated carbon, 10g of vermiculite, 2g of sodium chloride and 8g of deionized water, mix them evenly under nitrogen protection to prepare heating mixture; (2) Packaging the heating pack 2: The above mixture is placed into a flat bag made of breathable non-woven fabric (size 6cm×8cm), and the opening is heat-sealed to make the heating pack 2; (3) Fixing the heating pack 2: Apply a ring of medical-grade pressure-sensitive adhesive to the center of the inner side of the non-woven fabric backing layer 1, and fix the heating pack 2 flat.

[0037] Step S3: Cover and seal the breathable and leak-proof membrane 3. Take a piece of microporous polyethylene breathable membrane with a size of 8cm×10cm and a thickness of 0.05mm, cover it on the heating pack 2, and use a heat sealing machine to heat-seal the membrane with the non-woven fabric backing layer 1 around the perimeter to ensure that the heating pack 2 is completely sealed and leak-proof.

[0038] Step S4: Preparation and application of the plaster layer 4 (1) Preparation of Kaempferia galanga extract: Take the dried rhizome of Kaempferia galanga (black ginger), crush it to 20 mesh, add 8 times the amount of water and decoct twice for 1.5 hours each time. Combine the filtrates and concentrate under reduced pressure to an extract with a relative density of 1.25 (measured at 60℃) for later use. (2) Preparation of ointment: Weigh 75g of medical acrylate pressure-sensitive adhesive (solid content 40%), add 8g of kaempferia galanga extract (based on dry ointment), stir evenly, add 1g of azone as a penetration enhancer, and continue stirring until a uniform ointment is formed; (3) Coating: The paste is evenly coated on the inner surface of the breathable and leak-proof membrane 3. The coating thickness is controlled at 0.2 mm. It is then placed in a 50°C oven to dry for 15 minutes to remove some of the solvent.

[0039] Step S5: Cover with release paper 5 and cut. Cover the surface of the plaster layer 4 with glassine release paper, press lightly to make it adhere, and then use a cutting machine to cut the plaster into finished sizes of 10cm×12cm.

[0040] Step S6: Seal the packaging. Immediately pack the cut patches into aluminum-plastic composite film bags, one patch per bag. Vacuum seal and heat seal the bag. Store in a cool, dry place.

[0041] Understandably, this embodiment provides a basic external patch, the structure of which, from the outside to the inside, consists of a non-woven fabric backing layer 1, a heating pack 2, a breathable and leak-proof membrane 3, a plaster layer 4, and a release liner 5. The overall size of the patch is 10cm × 12cm. The heating pack 2, composed of iron powder, activated carbon, vermiculite, sodium chloride, and water, is fixed in the center of the backing layer and can maintain a heating temperature of 45℃ ± 5℃ for approximately 8 hours. It is sealed with a microporous polyethylene breathable and leak-proof membrane 3 to prevent leakage. The active ingredients of this patch are concentrated in the plaster layer 4, which is made by mixing medical pressure-sensitive adhesive and traditional Chinese medicine extract in a specific ratio. The main functional ingredient is *Kaempferia galanga* (black ginger) extract, accounting for 8%. The preparation method includes: cutting and preparing non-woven fabric backing; preparing, packaging and fixing heating pack 2; covering and hot-pressing to seal breathable and leak-proof membrane 3; preparing galangal (black ginger) extract extract by water decoction, mixing it with pressure-sensitive adhesive and penetration enhancer and then coating it into shape; finally covering with release liner paper 5, cutting and vacuum sealing packaging.

[0042] Example 2: Example of applying butterfly patch to the abdomen The butterfly-shaped patch suitable for the abdomen has a similar structural framework to that of Example 1, except that the non-woven backing layer 1 is designed in a biomimetic butterfly shape to better fit the abdominal curve, while the plaster layer 4 uses a specific compound black ginger formula.

[0043] Structural composition: Reference Figures 1-2 (The schematic diagram shows the outline of the butterfly shape.) The external patch containing galangal (black ginger) extract provided in this embodiment has the following structure from the outside to the inside: butterfly-shaped non-woven fabric backing layer 1, heating pack 2, breathable and leak-proof membrane 3, plaster layer 4, and release liner 5.

[0044] The structural parameters for each layer are as follows: The butterfly-shaped non-woven backing layer 1 is made of medical-grade elastic non-woven fabric. The overall outline is butterfly-shaped, with a maximum size (wingspan) of approximately 15cm × 12cm, a central abdominal width of approximately 8cm, and a thickness of 0.35mm, in order to improve the fit and comfort during application.

[0045] The heating pack 2 is preferably 7cm × 9cm in size and is fixed to the center of the inner side of the backing layer 1. It contains a heating composition consisting of: 35g iron powder, 6g activated carbon, 12g vermiculite, 2.5g sodium chloride, and 10g water. The heating temperature of the heating pack 2 is 50℃ ± 3℃, and the heating time is 10 hours.

[0046] The breathable and leak-proof membrane 3 is made of polyethylene film with microporous structure, with a thickness of 0.05mm and a size of 8cm×10cm. It completely covers the heating pack 2 and is sealed to the butterfly-shaped non-woven fabric backing layer 1 with medical hot melt adhesive on all four sides.

[0047] The plaster layer 4 is applied to the inside of the breathable and leak-proof membrane 3, covering an area slightly smaller than that of the membrane 3, with a thickness of 0.25 mm. The plaster layer 4 is made by mixing medical-grade acrylic pressure-sensitive adhesive and traditional Chinese medicine extract in a mass ratio of approximately 3:1. The traditional Chinese medicine extract consists of the following herbal extracts in the indicated weight proportions: Black ginger extract: 5-10 parts; Garcinia Cambogia extract: 3-4 parts; Atractylodes lancea extract: 3-6 parts; Salvia miltiorrhiza extract: 3-6 parts; Magnolia officinalis extract: 3-6 parts; Horse chestnut extract: 3-4 parts; Roasted hawthorn extract: 3-6 parts; Chicken blood vine extract: 5-7 parts; Citrus aurantium extract: 6-9 parts; Ophiopogon japonicus extract: 2-3.5 parts; Schisandra chinensis extract: 2-3.5 parts; Alisma plantago-aquatica extract: 8-10 parts; Poria cocos extract: 6.5-8.5 parts; Coix seed extract: 3-6 parts; Tangerine peel extract: 3-6 parts; Ointment base: 16.5-18 parts; Menthol: 0.5-1.5 parts.

[0048] Release paper 5 is made of glassine release paper that matches the outline of the butterfly-shaped patch and covers the outside of the plaster layer 4.

[0049] The preparation method of the abdominal butterfly patch is as follows: Step S1: Prepare butterfly-shaped nonwoven backing layer 1. Take medical-grade elastic spunlace nonwoven fabric and cut it using a special butterfly-shaped mold to obtain a butterfly-shaped sheet with a maximum size of approximately 15cm × 12cm and a thickness of 0.35mm, which will serve as backing layer 1 for later use.

[0050] Step S2: Preparation and fixation of heating pack 2.

[0051] (1) Preparation of heating composition: Weigh 35g iron powder, 6g activated carbon, 12g vermiculite, 2.5g sodium chloride and 10g deionized water, and mix them evenly under nitrogen protection; (2) Packaging the heating pack 2: Put the mixture into a 7cm×9cm flat bag made of breathable non-woven fabric and heat seal it; (3) Fixing the heating pack 2: Apply medical pressure-sensitive adhesive to the center area inside the butterfly-shaped non-woven fabric backing layer 1, and fix the heating pack 2 flat and attached.

[0052] Step S3: Cover and seal the breathable and leak-proof membrane 3. Take a piece of microporous polyethylene breathable membrane with a size of 8cm×10cm, cover it on the heating pack 2, and use a heat sealing machine to heat-press and seal it with the backing layer 1 around the membrane to form a sealed cavity.

[0053] Step S4: Preparation and application of the plaster layer 4.

[0054] (1) Preparation of extracts of traditional Chinese medicine: a. Weigh out the following dried medicinal materials in the prescribed amount: galangal (black ginger), garcinia cambogia, atractylodes lancea, salvia miltiorrhiza, magnolia officinalis, horse chestnut, charred hawthorn, chicken blood vine, immature bitter orange, ophiopogon japonicus, schisandra chinensis, alisma plantago-aquatica, poria cocos, coix seed, and tangerine peel.

[0055] b. Group extraction: To optimize extraction efficiency, black ginger was decocted twice with 8 times the amount of water, 1.5 hours each time, and the extract was obtained by filtration. The remaining fourteen medicinal materials were mixed, pulverized to 30 mesh, and extracted twice with 10 times the amount of 60% ethanol, refluxed for 1.5 hours each time, and the extract was obtained by filtration. The ethanol was then recovered.

[0056] c. Combine the above-mentioned black ginger aqueous extract and the alcohol extract concentrate of the remaining medicinal materials, mix them, and concentrate under reduced pressure to a thick paste with a relative density of 1.30-1.35 (measured at 60℃) to obtain the compound Chinese medicine extract.

[0057] (2) Preparation of ointment: Weigh 32g of the above compound Chinese medicine extract (based on dry ointment), add 1.0g of menthol, mix with 68g of pre-prepared medical acrylate pressure-sensitive adhesive (solid content 40%), and stir thoroughly until a uniform ointment is formed.

[0058] (3) Coating: The paste is evenly coated on the inner surface of the breathable and leak-proof membrane 3. The coating thickness is controlled at 0.25 mm. It is then placed in a 55℃ oven and dried for 12 minutes to form the plaster layer 4.

[0059] Step S5: Cover with release liner 5. Cover the surface of the plaster layer 4 with the pre-cut glassine release liner that matches the butterfly shape, and press lightly to ensure adhesion.

[0060] Step S6: Sealing and Packaging. Place the finished patch into an aluminum-plastic composite film bag, vacuum seal it, and store it in a cool, dry place.

[0061] Understandably, this embodiment provides a butterfly-shaped patch specifically designed for the abdomen. Its unique butterfly-shaped backing structure better adapts to the physiological curvature of the abdomen, improving the stability and comfort of the application. The plaster layer uses a compound formula with 15 herbs, including galangal (black ginger) as the core, combined with ginseng, atractylodes, salvia miltiorrhiza, magnolia officinalis, and immature bitter orange. This formula addresses multiple therapeutic directions, such as warming, dispelling dampness, promoting blood circulation, regulating qi, and relieving indigestion, aiming to synergistically act on the abdomen. The preparation process employs a herbal grouping extraction method (black ginger extracted separately with water, the others with alcohol extraction) to more specifically extract the effective components from each herb. Combined with stable heat application at 50℃±3℃ for approximately 10 hours, it effectively promotes the transdermal absorption of the complex compound active ingredients, achieving a deep synergy between heat therapy and drug therapy, meeting the specific needs of abdominal care.

[0062] Example 3: Waist patch (with ingredients such as Garcinia Cambogia) The patch suitable for the waist has a similar structure to that in Example 1, except for the composition of the plaster layer 4: The plaster layer consists of 4 components: Black ginger extract: 7%; Garcinia Cambogia extract: 3%; Atractylodes lancea extract: 2.5%; Magnolia officinalis extract: 13%; Fructus Aurantii Immaturus extract: 10%; Mulberry bark extract: 13%; Tetrapanax papyrifer extract: 10%; Eupatorium fortunei extract: 10%; Cinnamon twig extract: 5%; Menthol: 1%; Medical pressure-sensitive adhesive: Balance; The composition of heating pack 2 was adjusted to: 35g iron powder, 6g activated carbon, 12g vermiculite, 2.5g salt, and 10g water. The heating temperature was 50℃±3℃, and the heating lasted for 10 hours.

[0063] The preparation method for the patch suitable for the waist is as follows: Steps S1-S3: Same as in Example 1, prepare the backing layer, heating pack 2 (adjust the heating components to: 35g iron powder, 6g activated carbon, 12g vermiculite, 2.5g sodium chloride, 10g water) and seal with a breathable and leak-proof membrane 3.

[0064] Step S4: Preparation and application of the plaster layer 4: (1) Preparation of extracts of traditional Chinese medicine: Weigh out the following ingredients according to the formula: 7g of small-flowered galangal (black ginger), 3g of garcinia cambogia, 2.5g of atractylodes lancea, 13g of magnolia officinalis, 10g of immature bitter orange, 13g of mulberry bark, 10g of tetrapanax papyriferus, 10g of eupatorium fortunei, and 5g of cinnamon twig; Mix and grind to 30 mesh, add 10 times the amount of water and soak for 2 hours, decoct 3 times, 1 hour each time, combine the filtrates, and concentrate under reduced pressure to a thick paste with a relative density of 1.30 (measured at 60℃); (2) Preparation of ointment: Take 30g of the above thick ointment (based on dry ointment), add 1g of menthol, mix with 70g of medical pressure-sensitive adhesive (solid content 40%), and stir until uniform; (3) Coat the inside of the breathable and leak-proof membrane 3 with a thickness of 0.25 mm and dry at 55°C for 10 minutes.

[0065] Steps S5-S6: Same as in Example 1, cover with release paper, cut, and package in aluminum-plastic bags.

[0066] Understandably, this embodiment provides a compound patch suitable for the waist, which, based on the basic structure of Embodiment 1, mainly adjusts the composition of the plaster layer 4 and the performance of the heating pack 2. The plaster layer 4 uses a compound traditional Chinese medicine extract, containing extracts of nine medicinal materials: galangal (black ginger), garcinia cambogia, atractylodes lancea, magnolia officinalis, immature bitter orange, mulberry bark, tetrapanax papyriferus, eupatorium fortunei, and cinnamon twig. Among them, the galangal extract accounts for 7%, and menthol is added to achieve a synergistic effect on the waist through multiple components. Correspondingly, the composition ratio of the heating pack 2 is adjusted, and the amount of materials such as iron powder is increased, so that its heating temperature is increased to 50℃±3℃ and the continuous heating time is extended to 10 hours to provide a stronger and more lasting heat therapy effect. The preparation method is similar to that of Embodiment 1, except that the traditional Chinese medicine extract is obtained by mixing and pulverizing the various medicinal materials, then using a water decoction process to extract and concentrate them into a thick paste, which is then mixed with the matrix and coated.

[0067] Example 4: Leg patch (containing ingredients such as Clematis chinensis) The patch for the legs has a similar structure to that in Example 1, except for the composition of the plaster layer 4: The plaster layer consists of 4 components: Black ginger extract: 6%; Clematis chinensis extract: 3%; Herba Clematis chinensis extract: 3.5%; Astragalus extract: 10%; Ligusticum chuanxiong extract: 10%; Poria cocos extract: 13%; Eupatorium japonicum extract: 10%; Achyranthes bidentata extract: 7%; Salvia miltiorrhiza extract: 2.5%; Menthol: 1%; Medical pressure-sensitive adhesive: Balance; The composition of heating pack 2 was adjusted to: 28g iron powder, 4g activated carbon, 8g vermiculite, 2g salt, and 6g water. The heating temperature was 42℃±3℃, and the heating lasted for 6 hours.

[0068] The preparation method for the patch suitable for the legs is as follows: Steps S1-S3: Same as in Example 1, prepare the backing layer, heating pack 2 (adjust the heating components to: 28g iron powder, 4g activated carbon, 8g vermiculite, 2g sodium chloride, and 6g water) and seal with a breathable and leak-proof membrane 3.

[0069] Step S4: Preparation and application of the plaster layer 4: (1) Preparation of extracts of traditional Chinese medicine: Weigh out the following ingredients according to the formula: 6g of small-flowered galangal (black ginger), 3g of clematis, 3.5g of clematis root, 10g of astragalus root, 10g of chuanxiong rhizome, 13g of poria cocos, 10g of eupatorium fortunei, 7g of achyranthes bidentata root, and 2.5g of salvia miltiorrhiza root; After mixing, add 8 times the amount of 70% ethanol and reflux extract twice, 1.5 hours each time. Combine the extracts, recover the ethanol, and concentrate to a thick paste. (2) Preparation of ointment: Take 25g of thick ointment (based on dry ointment), add 1g of menthol and 0.5g of borneol, and mix evenly with 75g of medical pressure-sensitive adhesive (solid content 40%); (3) Coat the inside of the breathable and leak-proof membrane 3 with a thickness of 0.18 mm and dry at 45°C for 20 minutes.

[0070] Steps S5-S6: Same as in Example 1, cover with release paper, cut, and package in aluminum-plastic bags.

[0071] Understandably, this embodiment provides a patch suitable for the legs, with a structural framework consistent with Embodiment 1. However, the formulation of the plaster layer 4 and the parameters of the heating pack 2 have been specifically designed for leg use. The plaster layer 4 uses a compound formula primarily for dispelling wind and dampness, and promoting blood circulation. It contains 6% extract of Kaempferia galanga (black ginger) and is combined with extracts of Clematis chinensis, Clematis armandii, Astragalus membranaceus, Ligusticum chuanxiong, Poria cocos, Lycopus lucidus, Achyranthes bidentata, and Salvia miltiorrhiza. Borneol is added to enhance the cooling and penetrating sensation. After adjusting the proportions of the heating pack 2 components, the heating temperature is slightly reduced to 42℃±3℃, with a duration of 6 hours, making it more suitable for prolonged application to the leg skin. The key difference in the preparation process is that the herbal extracts are obtained using a 70% ethanol reflux extraction method to more effectively extract the fat-soluble active ingredients from the medicinal materials. Subsequent steps are similar to those in the basic Embodiment 1.

[0072] Example 5: Arm patch (containing horse chestnut and other ingredients) The patch suitable for the arm has a similar structure to that in Example 1, except for the composition of the plaster layer 4: The plaster layer consists of 4 components: Black ginger extract: 9%; Horse chestnut extract: 3%; Flying dragon's paw blood extract: 4%; Black vine extract: 3%; Salvia miltiorrhiza extract: 3%; Luffa sponge extract: 13%; Turmeric extract: 19%; Cinnamon twig extract: 9%; Lulutong extract: 14%; Menthol: 1%; Medical pressure-sensitive adhesive: Balance; The heating pack 2 has the same composition as in Example 1.

[0073] The preparation method for patches suitable for the arm is as follows: Steps S1-S3: Same as in Example 1, the composition of the backing layer and heating pack 2 is the same as in Example 1.

[0074] Step S4: Preparation and application of the plaster layer 4: (1) Preparation of extracts of traditional Chinese medicine: Weigh out the following ingredients according to the formula: 9g of small-flowered galangal (black ginger), 3g of horse chestnut, 4g of dragon's palm blood, 3g of black bone vine, 3g of salvia miltiorrhiza, 13g of loofah sponge, 19g of turmeric, 9g of cinnamon twig, and 14g of luffa cylindrica; Grind to 40 mesh, add 9 times the amount of water to soak for 3 hours, decoct 4 times, 45 minutes each time, combine the filtrates, and concentrate to a thick paste with a relative density of 1.28 (measured at 60℃); (2) Preparation of ointment: Take 35g of thick ointment (based on dry ointment), add 1g of menthol, and mix evenly with 65g of medical pressure-sensitive adhesive (solid content 40%); (3) Coat the inside of the breathable and leak-proof membrane 3 with a thickness of 0.22 mm and dry at 50°C for 15 minutes.

[0075] Steps S5-S6: Same as in Example 1, cover with release paper, cut, and package in aluminum-plastic bags.

[0076] Understandably, this embodiment provides a patch suitable for the arm, with the same overall structure as in Embodiment 1, and the composition of the heating pack 2 is also consistent. The plaster layer 4 employs a high proportion of compound formulation emphasizing blood circulation, removing blood stasis, and unblocking meridians. Among these, the extract of *Kaempferia galanga* (black ginger) accounts for 9%, the highest among all embodiments, and is combined with extracts of *Aesculus hippocastanum*, *Gnaphalium affine*, *Smilax china*, *Salvia miltiorrhiza*, *Luffa cylindrica*, *Curcuma longa*, *Cinnamomum cassia*, and *Ligusticum striatum*, with menthol acting as a penetration enhancer. This design aims to address issues such as arm pain and poor blood circulation. In the preparation method, the herbal extracts are prepared by pulverizing the herbs, soaking them for a long time (3 hours), and then decocting them multiple times (4 times) to obtain a thick paste, aiming to fully extract the effective components. The remaining coating and encapsulation steps are the same as in Embodiment 1.

[0077] Comparative Example 1: Control patch without heating pack As a comparison of the effects of the present invention, this comparative example provides a topical patch without a heating structure. Its plaster layer formula is exactly the same as that of Example 1, but the overall structure is simplified and does not include a heating pack and related sealing structure.

[0078] Structural composition: Reference Figure 1 The external patch containing Kaempferia galanga (black ginger) extract provided in this comparative example has the following structure from the outside to the inside: a non-woven fabric backing layer 1, a plaster layer 4, and a release liner 5.

[0079] The structural parameters for each layer are as follows: The nonwoven backing layer 1 uses the same medical-grade nonwoven fabric as in Example 1, with a size of 10cm × 12cm and a thickness of 0.3mm.

[0080] The plaster layer 4 is directly coated on the inner surface of the non-woven fabric backing layer 1, with a thickness of 0.2 mm. Its composition is exactly the same as that in Example 1: it is made by mixing medical pressure-sensitive adhesive and traditional Chinese medicine extract at a mass ratio of 3:1. The extract of small-flowered galangal (black ginger) accounts for 8%, and the remainder is matrix excipients, and contains the same proportion of the penetration enhancer azone.

[0081] Release paper 5 is made of glassine release paper and is used to cover the outside of the plaster layer 4.

[0082] The preparation method of the non-heating patch is as follows: Step S1: Prepare nonwoven backing layer 1. Take medical-grade spunlace nonwoven fabric and cut it into rectangular sheets of 10cm×12cm with a thickness of 0.3mm, as nonwoven backing layer 1, for later use.

[0083] Step S2: Preparation and application of the plaster layer 4.

[0084] (1) Preparation of Kaempferia galanga extract: The method is exactly the same as step S4 (1) in Example 1. Take the dried rhizome of Kaempferia galanga (black ginger), crush it to 20 mesh, add 8 times the amount of water and decoct twice, 1.5 hours each time, combine the filtrates, and concentrate under reduced pressure to an extract with a relative density of 1.25 (measured at 60℃) for later use; (2) Preparation of ointment: Weigh 75g of medical acrylate pressure-sensitive adhesive (solid content 40%), add 8g of kaempferia galanga extract (based on dry ointment), stir evenly, add 1g of azone as a penetration enhancer, and continue stirring until a uniform ointment is formed; (3) Coating: The paste is evenly coated on the inner surface of the nonwoven backing layer 1, and the coating thickness is controlled at 0.2 mm. It is then placed in a 50°C oven to dry for 15 minutes to remove some of the solvent.

[0085] Step S3: Cover with release liner 5 and cut. Cover the surface of the plaster layer 4 with glassine release liner, press lightly to adhere it, and then use a cutting machine to cut the plaster into finished sizes of 10cm×12cm.

[0086] Step S4: Sealing and Packaging. Immediately pack the cut patches into aluminum-plastic composite film bags, one patch per bag. Vacuum seal and heat seal the bag. Store in a cool, dry place.

[0087] Understandably, this comparative example provides a control patch with the same active ingredients as the plaster in Example 1, but without the heating function. Its structure consists only of a non-woven fabric backing layer 1, a plaster layer 4, and a release liner 5, omitting the heating pack 2, the breathable and leak-proof membrane 3 used to encapsulate the heating pack, and the related fixation and sealing processes found in Example 1. This comparative example is intended as a negative or baseline control group in subsequent experiments (such as transdermal absorption rate, clinical efficacy comparison, etc.) to independently evaluate and demonstrate the independent contribution and value of the thermotherapy effect provided by the "heating pack" in this invention in promoting drug absorption and enhancing efficacy. Its preparation method is simpler than that of Example 1, with the core being ensuring the consistency of the plaster layer formulation.

[0088] In the above embodiments, the heating pack 2 is physically isolated from the plaster layer 4 by the breathable and leak-proof membrane 3, which not only prevents leakage and contamination but also ensures that heat is evenly conducted to the skin, promoting transdermal drug absorption. The traditional Chinese medicine extract mixed with medical pressure-sensitive adhesive in the plaster layer 4 has good adhesion and sustained-release properties. The patch structure is integrated, convenient to use, and suitable for different parts such as the waist, abdomen, legs, and arms, achieving a synergistic effect of heat therapy and drug therapy.

[0089] The technical effect data is as follows: 1. Transdermal absorption efficiency data: The Franz vertical diffusion cell method was used in vitro, with SPF-grade SD rat abdominal excised skin as the transdermal barrier, simulating the physiological environment of human skin at 32℃. The core active ingredient of Kaempferia galanga extract, 5,7-dimethoxyflavone (DMF), was used as the detection index. The concentration of the index component in the receiving solution was determined by high performance liquid chromatography (HPLC). The steady-state transdermal rate, 12-hour cumulative transdermal amount, and transdermal rate were calculated to evaluate the transdermal absorption efficiency of the patch, which conforms to the guidelines for in vitro transdermal testing in the Chinese Pharmacopoeia.

[0090] HPLC detection conditions: Waters UPLC was used with a Waters C18 column (4.6 mm × 250 mm, 5 μm), a mobile phase of methanol-water = 60:40 (v / v), a detection wavelength of 280 nm, a flow rate of 1.0 mL / min, and a column temperature of 30 °C. The DMF standard curve equation was y = 12589x + 235.6 (R² = 0.9998), with recoveries of 98.5%–102.3% and a precision RSD of 2.1%.

[0091] The test product was the finished patch from Examples 1-5. Additionally, a "traditional black ginger external application group" (black ginger powder applied directly) and a control group 1, "patch without heat pack" (same formula as Example 1 but without heat pack), were added as controls. Three parallel samples were set for each case. The receiving solution was polyethylene glycol 400-physiological saline (1:9, v / v). Samples were taken at 1, 2, 4, 6, 8, 10, and 12 hours after administration to simultaneously determine the concentration of 5,7-dimethoxyflavone (DMF) in the receiving solution. A blank control group and a skin integrity control group were also set up to ensure the validity of the experiment. The relative standard deviation (RSD) was ≤5%. The blank control group consisted of a blank patch without DMF, with other matrix components consistent with Example 1.

[0092] Heat therapy control: Examples 1-3 use built-in self-heating material to maintain heat therapy temperature at 50℃±3℃; Example 4 heat therapy temperature at 45℃±5℃; Example 5 heat therapy temperature at 42℃±3℃; all heat therapy groups continuously generate heat for 12 hours, and the temperature is recorded every 1 hour. Temperature fluctuations are all within the set range.

[0093] Table 1: Transdermal absorption test results of topical patches containing Kaempferia galanga (black ginger) extract Verification using the Franz diffusion cell method (pharmacopoeia standard) showed that the transdermal penetration rate of the single-component base patch in Example 1 reached 32.46±1.32%, while the transdermal penetration rate of Example 2, after optimization of the compound, increased to 48.93±2.05%. The steady-state transdermal rate fell within the reasonable range for similar herbal hot compress patches and was superior to traditional black ginger external application (traditional black ginger powder / ointment typically has an in vitro transdermal penetration rate below 25%, and even weaker without continuous hot compress assistance), directly demonstrating improved absorption efficiency. Heating temperature significantly affected the transdermal effect. Under a hot compress condition of 50℃±3℃, Examples 2 and 3 showed significantly better transdermal performance than patches at 45℃±5℃ and 42℃±3℃. Appropriate high temperatures can enhance the permeability of the stratum corneum, thereby accelerating the penetration of active ingredients. The transdermal penetration rate of Comparative Example 1 (without a heating pack) was only 22.38±1.16%, further validating the technical advantage of the synergistic effect of hot compress and drug therapy.

[0094] 2. Skin irritation: In accordance with GB / T 16886.10 "Biological Evaluation of Medical Devices Part 10: Irritation and Skin Sensitization Tests", the skin irritation of the patch of this invention was tested to fully ensure the safety of product use. Healthy New Zealand rabbits were used as test animals, divided into an intact skin group and a damaged skin group, with 3 female New Zealand rabbits in each group. The standard for preparing damaged skin was "to make a cross-shaped incision on the rabbit's back with a sterile scalpel blade, 0.5 mm deep and 1 cm long, without bleeding". Test areas of the same size (3cm × 4cm) were prepared on both sides of the spine on the back. The patch of each embodiment was cut into 2cm × 3cm samples and applied for 24 hours in a closed application and for 7 consecutive days (4 hours per day) to simulate actual use scenarios. After the patch was applied, it was removed. The skin erythema and edema of the New Zealand rabbits were observed at three time points: 1h, 24h, and 48h. The degree of irritation was evaluated according to the standard scoring method (erythema 0-4 points, edema 0-4 points, total score 0-8 points). The skin sensitization test was performed using the Guinea Pig Maximization Test (GPMT), which was divided into an induction period (3 applications) and a provocation period (1 application). The skin sensitization reaction was observed. The test results are shown in Table 2 below.

[0095] Table 2: Skin irritation test results of topical patches containing Kaempferia galanga (black ginger) extract According to the test results, the irritation scores for intact skin, damaged skin, and continuous 7-day application were all below 0.49, and the data of parallel samples within the group showed good consistency. Therefore, the medical-grade excipients, traditional Chinese medicine extracts, and preparation processes used in the patch of this invention all meet the requirements of biosafety, have excellent biocompatibility, and are non-irritating to the skin. They can be safely used for long-term application to different parts of the human body such as the waist, abdomen, legs, and arms.

[0096] 3. Paste adhesion properties: Referring to the YY / T 0148-2006 standard "Medical Pressure-Sensitive Adhesive Patches", the adhesive performance of the patch was comprehensively evaluated using three core indicators: initial tack, holding power, and peel strength, to ensure that the patch adheres firmly, is comfortable to use, and has no problems such as falling off or leaving residue. The test environment was controlled at a temperature of 23℃±2℃ and a humidity of 50%±5%RH. The samples were tested after equilibration for 24 hours. Three parallel samples were set up for each group, and the relative standard deviation (RSD) was ≤5% to ensure that the test results were reliable and repeatable.

[0097] (1) Initial tack test: The rolling ball method is used. The paste is fixed with the surface facing up on a test plate at an angle of 30°. A standard steel ball is selected and rolled from a specified height. The rolling distance of the steel ball on the surface of the paste is recorded. The shorter the rolling distance, the stronger the initial tack, which can reflect the adhesion effect of the patch when it is first applied.

[0098] (2) Adhesion test: Under a constant temperature environment of 25℃, the paste was cut into 25mm×100mm samples and pasted on a stainless steel test plate with a bonding area of ​​25mm×25mm. A 1kg weight was suspended at the free end of the sample, and the time it took for the paste to slide off the test plate was recorded to reflect the stability of the patch after long-term application.

[0099] (3) Peel strength test: The 180° peel method was used. The paste was attached to a stainless steel test plate and rolled back and forth 3 times with a 2kg pressure roller. After standing for 20 minutes, it was peeled at a speed of 300mm / min at 180°. The average peel force was recorded and the peel strength (N / 25mm) was calculated to reflect the adhesion force when the patch was removed. This avoids skin damage due to excessive peel force. The test results are shown in Table 3 below.

[0100] Table 3: Adhesion performance test results of topical patches containing Kaempferia galanga (black ginger) extract Based on the above data, the initial adhesion should be controlled between 7.80-8.8 mm. The smaller the value, the stronger the initial adhesion. Example 2 has the best initial adhesion (7.0±0.2 mm), which can quickly conform to the abdominal curve. Example 4 has a moderately reduced initial adhesion (8.8±0.4 mm) due to skin sensitivity, to avoid pulling and irritation during application. The holding power is precisely matched according to the usage time. Examples 2 and 3 (abdomen / waist patch, continuous heating for 10 hours) have a holding power of ≥10.0-10.5 hours, far exceeding the usage cycle, and can withstand large movements such as waist twisting and abdominal movement, completely solving the problem of traditional plasters falling off easily. Examples 1 and 5 (basic waist / abdomen / arm patch, continuous heating for 8 hours) have a holding power of ≥8.0-8.5 hours, and Example 4 (leg patch, continuous heating for 6 hours) has a holding power of ≥6.5 hours. All of them can stably cover the single use time, without the need for frequent replacement, improving convenience. The peel strength was strictly controlled within a mild range of 1.65-2.05 N / 25 mm. Examples 2 and 3 (abdomen / waist patch, for thicker stratum corneum) used a higher value (1.98-2.05 N / 25 mm) to ensure firmness, while Example 4 (leg patch) used a lower value (1.65±0.09 N / 25 mm) to reduce irritation during removal. No adhesive residue was left after application in all examples, balancing adhesion stability and skin gentleness.

[0101] 4. Human trial observation experiment: To verify the practical application effect of the patch of this invention in waist and abdomen shaping and metabolic regulation, the butterfly-shaped abdominal patch (compound) of Example 2 was selected as the test sample for a human trial observation experiment. The experiment followed the principles of voluntary participation and informed consent, excluding pregnant / lactating women, those with broken skin on the waist and abdomen, patients with severe metabolic diseases, and those allergic to the patch ingredients. Finally, 30 subjects with waist and abdomen shaping needs were included, including 15 men and 15 women, aged 25-45 years. The initial waist circumference of men was 95-102 cm, and that of women was 88-95 cm. The subjects' baseline physical condition was balanced with no significant differences, ensuring the objectivity of the experimental results.

[0102] The trial period was set at 1 month. Participants applied the patches according to the prescribed method: once daily for 4 hours each time, applied to the core area of ​​the waist and abdomen. During the application period, participants maintained a normal diet and moderate exercise (walking ≥6000 steps daily, avoiding strenuous exercise). Feelings and physical changes were recorded. Follow-up tests were conducted on days 7, 14, 28, and 30 to collect feedback on safety and effectiveness, ensuring the data was authentic, reliable, and traceable.

[0103] Shaping effect indicators: Before the start of the experiment (baseline), and on days 7, 14, 28, and 30, waist circumference was measured at the same horizontal position (2 cm above the navel) using a standard soft measuring tape. Measurements were taken three times each time, and the average value was calculated to determine the change in waist circumference. Simultaneously, the improvement in abdominal skin firmness was evaluated through subject self-assessment and researcher observation (categorized into three levels: significant improvement, slight improvement, and no change). Safety indicators: Record whether adverse reactions such as skin redness, swelling, itching, stinging, etc. occur during the entire application period, as well as problems such as patch detachment and residue. Focus on summarizing safety feedback at each follow-up point to evaluate the safety and comfort of product use.

[0104] Comfort evaluation: Subjects self-evaluated their skin discomfort and ease of movement during the application of the patch at each follow-up point, and the overall user experience of the product was evaluated.

[0105] Table 4: Results of Human Trial Observation of Butterfly-Shaped Abdominal Patch (Compound) Note: Male subjects had a baseline waist circumference of 95-102cm, and female subjects had a baseline waist circumference of 88-95cm. All data are mean ± standard deviation (x ± s). A negative value for waist circumference change indicates a reduction in waist circumference. Improvement rate of skin firmness = (significant improvement + slight improvement) number of subjects / total number of subjects of the corresponding gender × 100%. Adverse reactions included skin irritation, allergies, and patch-related discomfort. No adverse reactions occurred in either male or female subjects during the entire trial period.

[0106] The results of this human observation trial demonstrate that the butterfly-shaped abdominal patch (compound) showed significant and continuously improving waist and abdominal shaping effects in both male and female subjects during a one-month trial, adapting to the physiological characteristics of the waist and abdomen in different genders. After 30 days of the trial, the overall average waist circumference decreased by 3.3 cm, with men averaging 3.4 cm and women averaging 3.2 cm. The skin firmness improvement rate reached 80%. No adverse reactions such as skin irritation or allergies were observed throughout the trial, the patch fall-off rate was 0%, there was no adhesive residue, and the comfort score was above 8 out of 10. It possesses good safety and shaping effects, meeting the clinical needs of waist and abdominal care.

[0107] The above description is merely a preferred embodiment of the present invention and does not limit the patent scope of the present invention. Any equivalent structural or procedural transformations made based on the content of the present invention's specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the patent protection scope of the present invention.

Claims

1. A topical patch containing extract of galangal (black ginger), characterized in that, It includes a non-woven fabric backing layer (1), a heating pack (2), a breathable and leak-proof membrane (3), a plaster layer (4), and a release liner (5) stacked sequentially from the outside to the inside. The heating pack (2) is fixedly installed on the inner side of the non-woven fabric backing layer (1); The breathable and leak-proof membrane (3) covers the inside of the heating pack (2) and physically isolates it from the plaster layer (4), and the periphery of the breathable and leak-proof membrane (3) is sealed to the non-woven fabric backing layer (1). The plaster layer (4) is coated on the inner surface of the breathable and leak-proof membrane (3). The coating thickness of the plaster layer (4) is 0.1–0.3 mm, and it contains Kaempferia galanga (black ginger) extract. The mass percentage of Kaempferia galanga (black ginger) extract in the plaster layer (4) is 5–10%. The heating pack (2) contains a heating composition that can undergo an oxidative exothermic reaction after coming into contact with the air that passes through the nonwoven backing layer (1) and the breathable and leak-proof membrane (3).

2. The topical patch containing Kaempferia galanga (black ginger) extract according to claim 1, characterized in that, The heating composition includes iron powder, activated carbon, vermiculite, salt, and water.

3. The topical patch containing Kaempferia galanga (black ginger) extract according to claim 1, characterized in that, The plaster layer (4) is made by mixing medical pressure-sensitive adhesive with traditional Chinese medicine extract.

4. The topical patch containing Kaempferia galanga (black ginger) extract according to claim 1, characterized in that, The breathable and leak-proof membrane (3) is a polyethylene membrane with a microporous structure.

5. The topical patch containing Kaempferia galanga (black ginger) extract according to claim 1, characterized in that, The heating pack (2) contains a heating composition that can undergo an oxidative exothermic reaction after coming into contact with the air that passes through the non-woven backing layer (1) and the breathable leak-proof membrane (3). The heating temperature is 40℃–55℃ and the heating time is 3-12 hours, which is suitable for the metabolic needs of the application site.

6. The topical patch containing Kaempferia galanga (black ginger) extract according to claim 3, characterized in that, The plaster layer (4) is made of a mixture of medical pressure-sensitive adhesive and traditional Chinese medicine extract. The medical pressure-sensitive adhesive is suitable for long-term skin application and is gentle and non-irritating.

7. The topical patch containing Kaempferia galanga (black ginger) extract according to claim 3, characterized in that, The herbal extract uses Kaempferia galanga (black ginger) extract as its core ingredient, and is formulated with at least one of the following herbal extracts: Garcinia cambogia, Atractylodes lancea, Magnolia officinalis, Citrus aurantium, Morus alba root bark, Tetrapanax papyriferus, Eupatorium fortunei, Cinnamomum cassia, Menthol, Salvia miltiorrhiza, Crataegus pinnatifida (roasted), Alisma plantago-aquatica, Poria cocos, Coix lacryma-jobi, Citrus reticulata peel, Aesculus hippocastanum, Spatholobus suberectus, Ophiopogon japonicus, Liquidambar formosana, Achyranthes bidentata, Clematis chinensis, Astragalus membranaceus, Lycopus lucidus, Caulis Scutellariae, Ligusticum chuanxiong, and Schisandra chinensis, to achieve the synergistic effects of warming and promoting metabolism, reducing fat and shaping the body, and regulating qi and bowel movements.

8. The topical patch containing Kaempferia galanga (black ginger) extract according to claim 4, characterized in that, The breathable and leak-proof membrane (3) is a polyethylene membrane with a microporous structure, which ensures uniform heat conduction and prevents the paste from leaking out.

9. The topical patch containing Kaempferia galanga (black ginger) extract according to claim 1, characterized in that, The nonwoven backing layer (1) is medical-grade nonwoven fabric, and the release liner (5) is glassine release paper, which is suitable for convenient home use scenarios.

10. The topical patch containing Kaempferia galanga (black ginger) extract according to claim 1, characterized in that, The patch is an abdominal patch (butterfly patch), waist patch, leg patch, or arm patch; Among them, when the patch is an abdominal patch (butterfly patch), the plaster layer (4) contains extracts of small-flowered galangal (black ginger), garcinia cambogia, atractylodes lancea, salvia miltiorrhiza, magnolia officinalis, horse chestnut, charred hawthorn, chicken blood vine, immature bitter orange, ophiopogon japonicus, schisandra chinensis, alisma plantago-aquatica, poria cocos, coix seed, and tangerine peel, which are suitable for people who sit for long periods of time, have abdominal obesity, postpartum looseness, or edema due to bloating; When the patch is a waist patch, the plaster layer (4) contains extracts of small-flowered galangal (black ginger), garcinia cambogia, atractylodes lancea, magnolia officinalis, salvia miltiorrhiza, immature bitter orange, mulberry bark, datura stramonium, eupatorium fortunei, and cinnamon twig, which focus on regulating the blood circulation in the waist and abdomen. When the patch is a leg patch, the plaster layer (4) contains extracts of small-flowered galangal (black ginger), horse chestnut extract, clematis extract, clematis extract, cinnamon twig extract, astragalus extract, chuanxiong extract, poria extract, zedoaria extract, and achyranthes extract, which are suitable for poor leg circulation and soreness. When the patch is an arm patch, the plaster layer (4) contains extracts of small-flowered galangal (black ginger), horse chestnut extract, galangal blood extract, black bone vine extract, salvia miltiorrhiza extract, cinnamon twig extract, turmeric extract, luffa extract, and loofah extract, which specifically improve arm metabolism.

11. A method for preparing a topical patch containing Kaempferia galanga (black ginger) extract according to any one of claims 1-10, characterized in that, Includes the following steps: S1: Provide a non-woven backing layer (1); S2: A heating pack (2) is fixedly installed on the inner side of the non-woven fabric backing layer (1); S3: Cover the inside of the heating pack (2) with a breathable and leak-proof membrane (3), and seal the periphery of the breathable and leak-proof membrane (3) with the non-woven fabric backing layer (1), so that the heating pack (2) is encapsulated between the non-woven fabric backing layer (1) and the breathable and leak-proof membrane (3). S4: A plaster layer (4) containing Kaempferia galanga (black ginger) extract is coated on the inner surface of the breathable and leak-proof membrane (3). Menthol is added to the plaster layer (4) to neutralize the irritation and improve the comfort of use. S5: Cover the outside of the plaster layer (4) with release paper (5).

12. The preparation method according to claim 11, characterized in that, The coating thickness of the plaster layer (4) in step S4 is 0.1–0.3 mm; after step S5, the method further includes: placing the prepared patch in an aluminum-plastic composite film sealed bag for individual packaging to meet the needs of single use.

13. The preparation method according to claim 11, characterized in that, The preparation of the traditional Chinese medicine extract in step S4 adopts a water decoction or ethanol reflux extraction process to ensure the efficient retention of active ingredients such as Kaempferia galanga (black ginger) extract and Garcinia cambogia extract, thereby improving transdermal absorption efficiency.

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