A hot compress for treating scleroderma and a preparation method thereof

Abstract

This invention belongs to the technical field of skin disease treatment products, specifically relating to a topical hot compress for treating scleroderma and its preparation method. The topical hot compress for treating scleroderma is made from the following raw materials in parts by weight: 20-40 parts of Artemisia argyi, 20-40 parts of Cinnamomum cassia, 10-20 parts of Sparganium stoloniferum, 10-20 parts of Curcuma zedoaria, 10-20 parts of Loranthus parasiticus, 15-30 parts of Gynostemma pentaphyllum, 10-20 parts of Spirodela polyrhiza, 15-30 parts of Spirodela polyrhiza, 15-30 parts of Ephedra sinica, 20-40 parts of Clematis chinensis, 5-15 parts of Eupolyphaga sinensis, 15-25 parts of Eriocaulon buergerianum, 5-15 parts of Carthamus tinctorius, 3-6 parts of Dracaena cochinchinensis, 3-6 parts of processed Strychnos nux-vomica, 20-40 parts of Vaccaria segetalis, 20-40 parts of Astragalus membranaceus, 10-20 parts of Magnolia officinalis, 10-20 parts of Aconitum carmichaelii, and 22-40 parts of rice wine. This invention is a topical medication that eliminates the need for oral administration, treating the disease externally and guiding the pathogenic factors to a cure. It avoids the inconvenience of bitter medications and effectively relieves symptoms and promotes the cure of localized scleroderma.

Description

Technical Field

[0001] This invention belongs to the technical field of skin disease treatment products, specifically relating to a topical hot compress for treating scleroderma and its preparation method. Background Technology

[0002] Scleroderma is a connective tissue disease characterized by inflammation, degeneration, thickening, and fibrosis of the skin, eventually leading to hardening and atrophy. In the early stages, scleroderma may present as localized or multiple edematous plaques on the skin surface, accompanied by thickening and hardening of the skin. It may also lead to joint pain, muscle atrophy, and esophageal and lung lesions, becoming symptoms of systemic scleroderma.

[0003] Currently available treatments for scleroderma include immunosuppressants such as corticosteroids and cyclophosphamide tablets, which can effectively alleviate symptoms but cannot be taken long-term due to significant side effects. For localized skin symptoms, topical treatment is more beneficial for recovery.

[0004] There are also some topical preparations for treating scleroderma in the existing technology, such as a topical liniment for treating localized scleroderma and its preparation method disclosed in Chinese patent CN105147788A, and a Centella asiatica ointment, a topical gel dressing and its preparation method disclosed in Chinese patent CN112316205A. These topical preparations are used by rubbing or applying, and can be used for a long time, but the efficacy is not good. Summary of the Invention

[0005] To address the aforementioned technical problems, this invention provides a topical hot compress for treating scleroderma and its preparation method, particularly suitable for localized skin diseases. The topical hot compress for treating scleroderma provided by this invention is an external medication, eliminating the need for oral administration. It treats the disease externally, guiding the pathogenic factors to a point of healing. It eliminates the inconvenience of bitter medications and effectively relieves symptoms and promotes healing in localized scleroderma, demonstrating good therapeutic efficacy.

[0006] The first objective of this invention is to provide a topical hot compress for treating scleroderma, made from the following raw materials in parts by weight: 20-40 parts of Artemisia argyi, 20-40 parts of Cinnamomum cassia, 10-20 parts of Sparganium stoloniferum, 10-20 parts of Curcuma zedoaria, 10-20 parts of Loranthus parasiticus, 15-30 parts of Gynostemma pentaphyllum, 10-20 parts of Spirodela polyrhiza, 15-30 parts of Ephedra sinica, 20-40 parts of Clematis chinensis, 5-15 parts of Eupolyphaga sinensis, 15-25 parts of Eriocaulon buergerianum, 5-15 parts of Carthamus tinctorius, 3-6 parts of Dracaena cochinchinensis, 3-6 parts of processed Strychnos nux-vomica, 20-40 parts of Vaccaria segetalis, 20-40 parts of Astragalus membranaceus, 10-20 parts of Magnolia officinalis, 10-20 parts of Aconitum carmichaelii, and 22-40 parts of rice wine.

[0007] The effects of each ingredient in this invention are as follows:

[0008] Artemisia leaves, with their light and volatile nature, are pungent and warm, reaching the exterior, and are considered the foremost in warming Yang. They warm the meridians, dispel cold, unblock the channels, and open the orifices. They also have the effects of warming Qi and blood, dispelling dampness and cold, promoting Qi transformation, and softening the skin.

[0009] Cinnamon twigs can induce sweating, relieve muscle tension, warm and unblock the meridians, promote yang energy in the limbs, and assist yang energy transformation.

[0010] The three-edged spar is used to break up blood stasis, promote qi circulation, soften hard masses, disperse nodules, and soften the skin.

[0011] Curcuma zedoaria promotes qi circulation, breaks up blood stasis, softens the skin, and resists tissue fibrosis.

[0012] If he were to be beaten, his merit would be comparable to that of Liu Ji Nu. It is a mild, blood-activating medicine that can accelerate fracture healing.

[0013] Liaojiangshi is a traditional Chinese medicine from Shaanxi Province. It is used to promote blood circulation, dissipate stagnation, relieve pain and swelling, and fight cancer.

[0014] Duckweed, being light and reaching the skin, disperses external pathogens and clears the meridians and orifices.

[0015] Ephedra promotes sweating, dispels cold, and clears the meridians and orifices. It penetrates the pores and softens the skin.

[0016] Clematis chinensis is the premier herb for softening and dispersing nodules, unblocking the twelve meridians, promoting blood circulation, and softening the skin.

[0017] Earthworm has the effects of reducing swelling and relieving pain, removing blood stasis and promoting blood circulation, softening and dispersing nodules, and softening the skin.

[0018] Pageworms are adept at moving sideways and are skilled at clearing the meridians, breaking up blood stasis, reducing swelling and dissipating nodules. They are an essential medicine for treating masses, injuries from falls and blows, and hard lumps on the skin.

[0019] Safflower warms the body and invigorates blood circulation. It promotes blood flow, removes blood stasis, and relieves pain.

[0020] Dragon's blood has the functions of promoting blood circulation, relieving pain, removing blood stasis, stopping bleeding, promoting tissue regeneration, and healing sores.

[0021] Processed strychnine seeds can promote blood circulation, remove blood stasis, clear the meridians, and relieve pain.

[0022] Wang Bu Liu Xing (Semen Vaccariae) unblocks the twelve meridians, invigorates blood circulation, removes blood stasis, opens the orifices and unblocks the collaterals, and promotes diuresis and reduces swelling.

[0023] Astragalus membranaceus (Huang Qi) can replenish qi and raise yang, strengthen the body's defenses and consolidate the exterior, promote diuresis and reduce swelling, generate fluids and nourish blood, and assist yang in transforming qi.

[0024] Magnolia officinalis is used to dry dampness, resolve phlegm, regulate qi, and eliminate stagnation.

[0025] Aconitum carmichaelii warms the yang and transforms qi, unblocks the twelve meridians, dispels cold and relieves pain, and restores yang and rescues from collapse.

[0026] Yellow wine, considered the best of all medicines, can unblock the twelve meridians, warm the yang, invigorate blood circulation, and relieve pain by clearing the channels, thus acting as a medium.

[0027] The formulation principle of this invention's external hot compress for treating scleroderma is as follows: The principal ingredients are Artemisia argyi, Cinnamomum cassia, Aconitum carmichaelii, Ephedra sinica, and Astragalus membranaceus, whose main functions are warming the Yang, dispelling cold, and promoting blood circulation. The assistant ingredients are Gypsum fibrosum, Ephedra sinica, Clematis chinensis, Eupolyphaga sinensis, Lysimachia christinae, and Lysimachia christinae, whose main functions are softening and dispersing nodules, promoting blood circulation, and softening the skin. The adjuvant ingredients are Sparganium stoloniferum, Curcuma zedoaria, Spirodela polyrhiza, Carthamus tinctorius, Dragon's blood, processed Strychnos nux-vomica, Magnolia officinalis, and rice wine, whose main functions are promoting blood circulation, removing blood stasis, softening and dispersing nodules, and resolving phlegm and nodules. The main effects of the combined ingredients are to invigorate Qi and warm the Yang, promote blood circulation, resolve phlegm and nodules, and soften the skin. It has excellent effects in treating localized scleroderma, chilblains, and cold sores.

[0028] The preferred topical hot compress for treating scleroderma, after decades of clinical practice and modifications to the drug formulation, is made from the following ingredients in parts by weight: 30 parts Artemisia argyi, 30 parts Cinnamomum cassia, 15 parts Sparganium stoloniferum, 15 parts Curcuma zedoaria, 15 parts Rhizoma Scutellariae Radix, 20 parts Glehnia littoralis, 15 parts Spirodela polyrhiza, 20 parts Ephedra sinica, 30 parts Clematis chinensis, 10 parts Eupolyphaga sinensis, 20 parts Carthamus tinctorius, 5 parts Dragon's Blood, 5 parts Prepared Strychnos nux-vomica, 30 parts Vaccaria segetalis, 30 parts Astragalus membranaceus, 15 parts Magnolia officinalis, 15 parts Aconitum carmichaelii, and 33 parts rice wine. This formula has good efficacy and a high drug effectiveness rate.

[0029] A second objective of this invention is to provide a method for preparing a topical hot compress for treating scleroderma, comprising:

[0030] Prepare the raw materials according to their respective weight proportions, mix all the raw materials except for the rice wine, and grind them into a powder of 40-60 mesh.

[0031] Add rice wine to the medicinal powder, mix to moisten the powder, put it into a cloth bag, heat it, and you will get a topical hot compress for treating scleroderma.

[0032] Of the above preparation methods, the preparation of the medicinal powder is simple. It is made by using rice wine as a base, putting it into a cloth bag, applying it with heat, and using it conveniently. It also leaves very little residue on the skin and is easy to clean after application.

[0033] Preferably, the rice wine is a modified Tapai rice wine, and the alcohol content is adjusted to 15 degrees using edible ethanol.

[0034] Preferably, the bag is made of gauze. Gauze has good breathability, which facilitates the penetration of the active ingredients in the powder into the skin.

[0035] Preferably, the temperature of the heated topical compress is 40℃~48℃. This is a temperature that the human body can tolerate without easily causing burns, and it also helps the active ingredients in the powder to be released and penetrate into the skin.

[0036] Based on the same inventive concept, this invention also provides another method for preparing a topical hot compress for treating scleroderma, comprising:

[0037] Prepare the raw materials according to their respective weight proportions, mix them, and grind them into a powder of 40-60 mesh.

[0038] Moisten the medicinal powder with rice wine and put it into a cloth bag;

[0039] After the medicine packet is placed in the cloth bag, it is placed in a plastic packaging bag, sealed, and refrigerated at 4℃~10℃ for 1 day to 2 days.

[0040] Heating produces a topical hot compress for treating scleroderma.

[0041] In the preparation method of this invention, refrigeration allows the active ingredients in the raw materials to integrate, reducing drug sensitization and improving efficacy. Preferably, the cloth bag is made of gauze, and the temperature of the heated external compress is 40°C to 48°C.

[0042] Preferably, during refrigeration, a refrigerant is placed inside the plastic bag, and the refrigerant coats the outside of the medicine bag. After refrigeration, the medicine bag is removed, heated, and used as a topical hot compress. The refrigerant is uncrushed mugwort leaves or safflower. Mugwort leaves are leaf-shaped, and safflower petals are petals; both are relatively thin and have high volatile components. Existing technologies often use them to make mugwort essential oil and safflower essential oil. This invention uses mugwort leaves or petals as a refrigerant, allowing the volatiles in these two materials to slowly evaporate and penetrate into the medicine bag under low-temperature conditions. Note that high-temperature storage is not used, because under high-temperature conditions, the volatiles evaporate too quickly, leaving only a small amount on the surface of the medicine bag, while most of the volatiles will dissipate and be wasted.

[0043] Preferably, the amount of refrigerant used per 100g of powder does not exceed 50g. Preferably, the refrigerant is a single layer wrapped around the outer surface of the medicine packet.

[0044] Preferably, after refrigeration, the bottom surface of the plastic package is perforated with holes of 1mm to 2mm in diameter, with at least three holes (e.g., 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 holes). The plastic package is then placed with the bottom surface facing down in a steamer and heated to 60℃ to 65℃, followed by cooling to 40℃ to 48℃. This method allows water vapor to penetrate into the medicine package. Heating to 60℃ to 65℃ first is necessary because the powder inside the medicine package is not easily heated. Heating to a slightly higher temperature first, followed by cooling to 40℃ to 48℃, yields a topical hot compress agent, which is then used for hot compresses. Preferably, using a steamer with controllable heating temperature, and maintaining the heating temperature at 60℃ to 65℃, makes it easier to control the temperature of the topical hot compress agent.

[0045] Scleroderma presents with localized coldness, hardening, skin atrophy, and blocked pores, resulting in anhidrosis, hair loss, and difficulty in penetrating and absorbing ointments. The goal of this invention is to utilize the warmth of a hot compress to open the skin's pores, facilitating drug penetration and absorption. Combined with the synergistic effect of warming, blood-activating, and meridian-clearing medications, achieving the desired therapeutic effect is inevitable.

[0046] Compared with existing technologies, the present invention has at least the following beneficial effects: The main functions of the external hot compress for treating scleroderma provided by the invention are to invigorate qi and warm yang, promote blood circulation and unblock collaterals, resolve phlegm and dissipate nodules, soften the skin, and treat localized scleroderma, chilblains, and cold sores. The external hot compress for treating scleroderma provided by the invention is a topical medication, requiring no oral administration. Localized scleroderma manifests as localized coldness, hardening, and blocked pores, making it difficult for commonly used ointments or topical preparations to penetrate and be absorbed, thus ultimately improving the efficacy of the medication. Attached Figure Description

[0047] Figure 1 The images show the effects of treatment for volunteer 1. A represents before treatment, and B represents after treatment.

[0048] Figure 2 The images show the effects of treatment on volunteer 2. A represents before treatment, and B represents after treatment.

[0049] Figure 1 and Figure 2 In the diagram, the circled area indicates the treatment location. Detailed Implementation

[0050] To enable those skilled in the art to better understand and implement the technical solutions of the present invention, the present invention will be further described below in conjunction with specific embodiments and accompanying drawings.

[0051] In existing technologies, oral medications such as glucocorticoids and cyclophosphamide tablets have significant side effects and cannot be taken long-term. Topical preparations disclosed in Chinese patents CN105147788A and CN112316205A are not absorbed and have poor efficacy. For these reasons, the present invention provides a topical hot compress for treating scleroderma, made from the following raw materials in parts by weight: 20-40 parts of Artemisia argyi, 20-40 parts of Cinnamomum cassia, 10-20 parts of Sparganium stoloniferum, 10-20 parts of Curcuma zedoaria, 10-20 parts of Loranthus parasiticus, 15-30 parts of Gynostemma pentaphyllum, 10-20 parts of Spirodela polyrhiza, 15-30 parts of Ephedra sinica, 20-40 parts of Clematis chinensis, 5-15 parts of Eupolyphaga sinensis, 15-25 parts of Eriocaulon buergerianum, 5-15 parts of Carthamus tinctorius, 3-6 parts of Dracaena cochinchinensis, 3-6 parts of processed Strychnos nux-vomica, 20-40 parts of Vaccaria segetalis, 20-40 parts of Astragalus membranaceus, 10-20 parts of Magnolia officinalis, 10-20 parts of Aconitum carmichaelii, and 22-40 parts of rice wine. Its main functions are to invigorate qi and warm yang, promote blood circulation and unblock collaterals, resolve phlegm and dissipate nodules, and soften the skin. It has good effects in treating localized scleroderma, chilblains, and cold sores.

[0052] The following are some specific embodiments and experimental results to demonstrate the effectiveness of the present invention.

[0053] The rice wine used in the various embodiments of this invention is adjusted Tapai rice wine. Tapai rice wine is a type of Huadiao wine, product number 8675246354. The alcohol content of Tapai rice wine is adjusted to 15 degrees with edible ethanol to obtain the adjusted Tapai rice wine. In the following embodiments and experiments, it is referred to as rice wine for future reference.

[0054] Example 1

[0055] A topical hot compress for treating scleroderma, the formulation of which is made from the following raw materials in parts by weight:

[0056] 30 parts Artemisia argyi, 30 parts Cinnamomum cassia, 15 parts Sparganium stoloniferum, 15 parts Curcuma zedoaria, 15 parts Rhizoma scutellariae, 20 parts Glehnia littoralis, 15 parts Spirodela polyrhiza, 20 parts Ephedra sinica, 30 parts Clematis chinensis, 10 parts Eupolyphaga sinensis, 20 parts Achyranthes bidentata, 10 parts Carthamus tinctorius, 5 parts Dragon's Blood, 5 parts Prepared Strychnos nux-vomica, 30 parts Vaccaria segetalis, 30 parts Astragalus membranaceus, 15 parts Magnolia officinalis, 15 parts Aconitum carmichaelii, and 33 parts Shaoxing wine.

[0057] Example 2

[0058] A topical hot compress for treating scleroderma, the formulation of which is made from the following raw materials in parts by weight:

[0059] 20 parts Artemisia argyi, 20 parts Cinnamomum cassia, 10 parts Sparganium stoloniferum, 10 parts Curcuma zedoaria, 10 parts Rhizoma floribunda, 15 parts Glehnia littoralis, 10 parts Spirodela polyrhiza, 15 parts Ephedra sinica, 20 parts Clematis chinensis, 5 parts Eupolyphaga sinensis, 15 parts Achyranthes bidentata, 5 parts Carthamus tinctorius, 3 parts Dragon's Blood, 3 parts Prepared Strychnos nux-vomica, 20 parts Vaccaria segetalis, 20 parts Astragalus membranaceus, 10 parts Magnolia officinalis, 10 parts Aconitum carmichaelii, 22 parts Yellow rice wine.

[0060] Example 3

[0061] A topical hot compress for treating scleroderma, the formulation of which is made from the following raw materials in parts by weight:

[0062] 40 parts Artemisia argyi, 40 parts Cinnamomum cassia, 20 parts Sparganium stoloniferum, 20 parts Curcuma zedoaria, 20 parts Rhizoma salsa, 30 parts Glehnia littoralis, 20 parts Spirodela polyrhiza, 30 parts Ephedra sinica, 40 parts Clematis chinensis, 15 parts Eupolyphaga sinensis, 25 parts Achyranthes bidentata, 15 parts Carthamus tinctorius, 6 parts Dragon's Blood, 6 parts Prepared Strychnos nux-vomica, 40 parts Vaccaria segetalis, 40 parts Astragalus membranaceus, 20 parts Magnolia officinalis, 20 parts Aconitum carmichaelii, and 40 parts Shaoxing wine.

[0063] The animal testing methods are as follows:

[0064] (1) Experimental animals: BALB / c mice, SPF grade, female, 6 weeks old, weighing 18g to 22g.

[0065] (2) Test drugs: The topical hot compresses for treating scleroderma prepared in each embodiment, and the "Soft Skin Hot Compress Powder" prepared prior to this invention. The referenced document is: Han Shirong et al., Experimental study on the application of "Soft Skin Hot Compress Powder" to a mouse model of localized scleroderma, Chinese Journal of Practical Medical Research, June 2010, Vol. 6, No. 6. The drug composition formula in that document did not disclose the specific weight parts of the raw materials and their compatibility. The formulation of this invention is a newly proposed formulation based on continuous clinical observation and summarization, which strengthens the components of warming yang and promoting blood circulation, clearing the meridians and opening the orifices, and softening the skin.

[0066] (3) Modeling: The specific modeling method refers to the above experimental study on the application of "Soft Skin Hot Compress Powder" to a mouse model of localized scleroderma.

[0067] (4) Treatment: Skin from healthy BALB / c mice served as the blank control group. Mice that successfully developed the scleroderma without any drug treatment served as the model group. The above-mentioned "soft skin hot compress powder" was applied topically to the model skin for 26 days, serving as the drug control group. Physiological saline was used as the reagent control group. The topical hot compress for treating scleroderma of this invention was applied once daily for 30 minutes, with one packet of medicine used once daily, serving as the experimental group.

[0068] The specific preparation method of the topical hot compress for treating scleroderma of the present invention is as follows:

[0069] Experimental Group 1: Prepare the raw materials according to the weight proportions of Example 1, mix the raw materials except for the rice wine, grind them into 40-mesh powder, add the rice wine to the powder, mix to moisten the powder, take 2g and put it into a layer of medical gauze bag, heat to 40℃ to obtain the external hot compress for treating scleroderma.

[0070] Experimental Group 2: Prepare the raw materials according to the weight proportions of Example 1, mix the raw materials except for the rice wine, pulverize them into 40-mesh powder, add the rice wine to the powder, mix to moisten the powder, take 2g and put it into a layer of medical gauze bag, heat to 45℃ to obtain the external hot compress for treating scleroderma.

[0071] Experimental Group 3: Prepare the raw materials according to the weight proportions of Example 1, mix the raw materials except for the rice wine, pulverize them into 40-mesh powder, add the rice wine to the powder, mix to moisten the powder, take 2g and put it into a layer of medical gauze bag, heat to 48°C, and obtain the external hot compress for treating scleroderma.

[0072] Experimental Group 4: Prepare the raw materials according to the weight proportions of Example 1. Mix the raw materials except for the rice wine, grind them into 40-mesh powder, add the rice wine to the powder, mix to moisten the powder, take 2g and put it into a layer of medical gauze bag, then put it in a plastic packaging bag, seal it, and refrigerate it at 4°C for 1 day. After that, take out the medicine pack and heat it to 40°C to obtain the external hot compress for treating scleroderma.

[0073] Experimental Group 5: Prepare the raw materials according to the weight proportions of Example 2, mix the raw materials except for the rice wine, pulverize them into 40-mesh powder, add the rice wine to the powder, mix to moisten the powder, take 2g and put it into a layer of medical gauze bag, heat to 40℃ to obtain the external hot compress for treating scleroderma.

[0074] Experimental Group 6: Prepare the raw materials according to the weight proportions of Example 3, mix the raw materials except for the rice wine, pulverize them into 40-mesh powder, add the rice wine to the powder, mix to moisten the powder, take 2g and put it into a layer of medical gauze bag, heat to 40℃ to obtain the external hot compress for treating scleroderma.

[0075] Experimental Group 7: Raw materials were prepared according to the weight proportions of Example 1. All raw materials except for the rice wine were mixed and pulverized into a 40-mesh powder. The rice wine was added to the powder and mixed to moisten it. 2g of the powder was placed in a medical gauze bag, then placed in a plastic bag, sealed, and refrigerated at 4°C for one day. Afterward, the medicine bag was removed and heated to 40°C to obtain a topical hot compress for treating scleroderma. During refrigeration, a refrigerant was placed inside the plastic bag and wrapped around the outside of the medicine bag. The refrigerant was unpulverized mugwort leaves, and 30g of refrigerant was used per 100g of powder.

[0076] Experimental Group 8: Raw materials were prepared according to the weight proportions of Example 2. All raw materials except for the rice wine were mixed and pulverized into a 40-mesh powder. The rice wine was added to the powder and mixed to moisten it. 2g of the powder was placed in a medical gauze bag, then placed in a plastic bag, sealed, and refrigerated at 4°C for one day. Afterward, the medicine bag was removed and heated to 40°C to obtain a topical hot compress for treating scleroderma. During refrigeration, a refrigerant was placed inside the plastic bag and wrapped around the outside of the medicine bag. The refrigerant was unpulverized mugwort leaves, and 30g of refrigerant was used per 100g of powder.

[0077] Experimental Group 9: Raw materials were prepared according to the weight proportions of Example 3. All raw materials except for the rice wine were mixed and pulverized into a 40-mesh powder. The rice wine was added to the powder and mixed to moisten it. 2g of the powder was placed in a medical gauze bag, then placed in a plastic bag, sealed, and refrigerated at 4°C for one day. Afterward, the medicine bag was removed and heated to 40°C to obtain a topical hot compress for treating scleroderma. During refrigeration, a refrigerant was placed inside the plastic bag and wrapped around the outside of the medicine bag. The refrigerant was unpulverized mugwort leaves, and 30g of refrigerant was used per 100g of powder.

[0078] Experimental Group 10: Raw materials were prepared according to the weight proportions of Example 1. All raw materials except for the rice wine were mixed and pulverized into a 40-mesh powder. The rice wine was added to the powder and mixed to moisten it. 2g of the powder was placed in a medical gauze bag, then placed in a plastic bag and sealed. The bag was refrigerated at 4°C for one day. Afterward, the bag was removed and heated to 40°C to obtain a topical hot compress for treating scleroderma. During refrigeration, a refrigerant was placed inside the plastic bag and wrapped around the outside of the bag. The refrigerant was uncrushed safflower, and 30g of refrigerant was used per 100g of powder.

[0079] Experimental Group 11: Raw materials were prepared according to the weight proportions of Example 2. All raw materials except for the rice wine were mixed and pulverized into a 40-mesh powder. The rice wine was added to the powder and mixed to moisten it. 2g of the powder was placed in a medical gauze bag, then placed in a plastic bag and sealed. The bag was refrigerated at 4°C for one day. Afterward, the bag was removed and heated to 40°C to obtain a topical hot compress for treating scleroderma. During refrigeration, a refrigerant was placed inside the plastic bag and wrapped around the outside of the bag. The refrigerant was uncrushed safflower, and 30g of refrigerant was used per 100g of powder.

[0080] Experimental Group 12: Raw materials were prepared according to the weight proportions of Example 3. All raw materials except for the rice wine were mixed and pulverized into a 40-mesh powder. The rice wine was added to the powder and mixed to moisten it. 2g of the powder was placed in a medical gauze bag, then placed in a plastic bag and sealed. The bag was refrigerated at 4°C for one day. Afterward, the bag was removed and heated to 40°C to obtain a topical hot compress for treating scleroderma. During refrigeration, a refrigerant was placed inside the plastic bag and wrapped around the outside of the bag. The refrigerant was uncrushed safflower, and 30g of refrigerant was used per 100g of powder.

[0081] Experimental Group 13: Prepare the raw materials according to the weight proportions of Example 1. Mix all raw materials except for the rice wine, grind them into 40-mesh powder, add the rice wine to the powder, mix to moisten the powder, take 2g and put it into a layer of medical gauze bag, then place it in a plastic packaging bag, seal it, and refrigerate it at 4°C for 1 day. During refrigeration, the plastic bag contains a refrigerant that wraps around the outside of the medicine bag. The refrigerant is unground mugwort leaves, and 30g of refrigerant is used for every 100g of medicine powder. After refrigeration, punch 10 holes with a diameter of 1mm on the bottom surface of the plastic bag; place it in a steamer and heat to 60°C, then cool to 40°C.

[0082] Experimental Group 14: Prepare the raw materials according to the weight proportions of Example 2. Mix all raw materials except for the rice wine, grind them into 40-mesh powder, add the rice wine to the powder, mix to moisten the powder, take 2g and put it into a layer of medical gauze bag, then place it in a plastic packaging bag, seal it, and refrigerate it at 4°C for 1 day. During refrigeration, the plastic bag contains a refrigerant that wraps around the outside of the medicine bag. The refrigerant is unground mugwort leaves, and 30g of refrigerant is used for every 100g of medicine powder. After refrigeration, punch 10 holes with a diameter of 1mm on the bottom surface of the plastic bag; place it in a steamer and heat to 60°C, then cool to 40°C.

[0083] Experimental Group 15: Prepare the raw materials according to the weight proportions of Example 3. Mix all raw materials except for the rice wine, grind them into 40-mesh powder, add the rice wine to the powder, mix to moisten the powder, take 2g and put it into a layer of medical gauze bag, then place it in a plastic packaging bag, seal it, and refrigerate it at 4°C for 1 day. During refrigeration, the plastic bag contains a refrigerant that wraps around the outside of the medicine bag. The refrigerant is unground mugwort leaves, and 30g of refrigerant is used for every 100g of medicine powder. After refrigeration, punch 10 holes with a diameter of 1mm on the bottom surface of the plastic bag; place it in a steamer and heat to 60°C, then cool to 40°C.

[0084] (5) Results of skin thickness analysis.

[0085] The results of skin thickness analysis are shown in Table 1. Skin thickness analysis provides a direct visual representation of the therapeutic effect in animal experiments. As can be seen from the results in Table 1, the therapeutic effects of experimental groups 1 through 15 of this invention were better than those of the other groups.

[0086] Table 1. Skin thickness analysis (mean ± standard deviation)

[0087] Grouping Number of experimental mice (units) Skin thickness (μm) Blank control group 6 15.37±0.56 Model group 6 38.49±0.35 Reagent control group 6 38.22±0.27 Drug control group 6 22.14±0.28 Experimental Group 1 6 18.24±0.15 Experimental Group 2 6 18.61±0.18 Experimental Group 3 6 18.53±0.32 Experimental Group 4 6 16.82±0.44 Experimental Group 5 6 18.55±0.51 Experimental Group 6 6 18.42±0.47 Experimental Group 7 6 16.00±0.33 Experimental Group 8 6 16.22±0.34 Experimental Group 9 6 16.14±0.35 Experimental Group 10 6 16.25±0.39 Experimental Group 11 6 16.13±0.08 Experimental Group 12 6 16.11±0.31 Experimental Group 13 6 15.68±0.09 Experimental Group 14 6 15.83±0.15 Experimental Group 15 6 15.92±0.32

[0088] (6) Results of antibacterial test

[0089] Since scleroderma can also be associated with fungal infections, we evaluated the antibacterial effects of different drugs. The experimental drug setup was as follows:

[0090] Control group: sterile distilled water.

[0091] Reagent group: The above-mentioned "soft skin hot compress powder" was sterilized at 121℃ for 20 minutes and then cooled to room temperature.

[0092] Experiment 1: A topical hot compress for treating scleroderma was prepared according to the method of Experiment 1 above, sterilized at 121℃ for 20 minutes, and then cooled to room temperature.

[0093] Experiment 2: The topical hot compress for treating scleroderma was prepared according to the method of Experiment 2 above, sterilized at 121℃ for 20 minutes, and then cooled to room temperature.

[0094] Experiment 3: The topical hot compress for treating scleroderma was prepared according to the method of Experiment 3 above, sterilized at 121℃ for 20 minutes, and then cooled to room temperature.

[0095] Experiment 4: The topical hot compress for treating scleroderma was prepared according to the method of Experiment 4 above, sterilized at 121℃ for 20 minutes, and then cooled to room temperature.

[0096] Experiment 5: The topical hot compress for treating scleroderma was prepared according to the method of Experiment 5 above, sterilized at 121℃ for 20 minutes, and then cooled to room temperature.

[0097] Experiment 6: The topical hot compress for treating scleroderma was prepared according to the method of Experiment 6 above, sterilized at 121℃ for 20 minutes, and then cooled to room temperature.

[0098] Experiment 7: A topical hot compress for treating scleroderma was prepared according to the method of Experiment 7 above, sterilized at 121°C for 20 minutes, and then cooled to room temperature.

[0099] Experiment 8: A topical hot compress for treating scleroderma was prepared according to the method of Experiment 8 above, sterilized at 121°C for 20 minutes, and then cooled to room temperature.

[0100] Experiment 9: A topical hot compress for treating scleroderma was prepared according to the method of Experiment 9 above, sterilized at 121°C for 20 minutes, and then cooled to room temperature.

[0101] Experiment 10: A topical hot compress for treating scleroderma was prepared according to the method of Experiment 10 above, sterilized at 121°C for 20 minutes, and then cooled to room temperature.

[0102] Experiment 11: A topical hot compress for treating scleroderma was prepared according to the method of Experiment 11 above, sterilized at 121°C for 20 minutes, and then cooled to room temperature.

[0103] Experiment 12: A topical hot compress for treating scleroderma was prepared according to the method of Experiment 12 above, sterilized at 121℃ for 20 minutes, and then cooled to room temperature.

[0104] Experiment 13: A topical hot compress for treating scleroderma was prepared according to the method of Experiment 13 above, sterilized at 121°C for 20 minutes, and then cooled to room temperature.

[0105] Experiment 14: A topical hot compress for treating scleroderma was prepared according to the method of Experiment 14 above, sterilized at 121°C for 20 minutes, and then cooled to room temperature.

[0106] Experiment 15: A topical hot compress for treating scleroderma was prepared according to the method of Experiment 15 above, sterilized at 121°C for 20 minutes, and then cooled to room temperature.

[0107] The test strains were the standard strain of *Spirostella thermophila* (ATCC36347) and the filamentous fungus (ATCC34921). Each of the above-mentioned drugs was added to the bacterial suspension, and the initial viable cell concentration was 10-1. 8 CFU / mL, add 1g of drug per 100mL of bacterial culture. After 20 minutes, count the viable bacteria concentration in the bacterial culture again and calculate the inhibition rate.

[0108] Antibacterial rate = 100 × (1 - concentration of viable bacteria after treatment / original concentration of viable bacteria)

[0109] Table 2 Antibacterial rate (mean ± standard deviation)

[0110]

[0111] The results showed that the topical hot compress prepared in this invention for treating scleroderma had a significant antibacterial effect, approaching 100%.

[0112] (7) Clinical treatment methods and effects

[0113] I. Clinical Diagnostic Criteria

[0114] Localized scleroderma can be diagnosed based on typical skin changes. Systemic sclerosis: American College of Rheumatology (ARA) 1998 criteria:

[0115] (1) Main criteria: hard skin changes near the metacarpophalangeal joints, which can affect the entire limb, face, body and trunk.

[0116] (2) Secondary criteria: finger scleroderma, with the above skin changes limited to the fingers; pitted scars and disappearance of finger pads at the fingertips; basal fibrosis of both lungs.

[0117] (3) Other signs that may aid in diagnosis: Raynaud's phenomenon, polyarthritis or arthralgia, esophageal peristalsis, skin pathology, collagen fiber swelling and fibrosis, etc.

[0118] Note that the above clinical diagnostic criteria are based on the indicators used in current clinical diagnostic activities, including but not limited to the primary criteria, secondary criteria, or other manifestations that are helpful for diagnosis.

[0119] II. Patient Enrollment

[0120] Patients with scleroderma, 100 in each group, half male and half female, aged 20 to 55 years.

[0121] III. Criteria for Evaluating Therapeutic Effect

[0122] Recovery: The skin lesions have partially returned to normal, the skin is soft, and only mild pigmentation or atrophy remains.

[0123] Significant effect: More than 50% of the skin lesions return to normal, the skin gradually softens, and clinical symptoms are significantly reduced.

[0124] Effective: Partial improvement in skin lesions, improvement in skin hardening, and improvement in clinical symptoms.

[0125] Ineffective: Treatment lasts for more than 4 months without any signs of improvement, or even worsening of the condition.

[0126] IV. External Hot Compress Agents

[0127] Due to the difficulty in obtaining clinical cases, and based on the experimental results in Table 1, the effects of experimental groups 1-3 were comparable, as were those of experimental groups 7-12. Considering sample size and cost, this invention selected experimental groups 1, 4, and 7 to prepare the topical hot compresses for treating scleroderma, which were then used as the topical hot compresses for clinical treatment. Experimental groups 13-15 were not used in the clinical trials of this invention due to the complexity of their preparation methods.

[0128] V. Treatment Plan

[0129] Apply 50g twice daily. Apply the external heat compress for 30 minutes, using an infrared heating tool to maintain warmth during the compress. Continue treatment for 5 months.

[0130] Table 3. Statistics on treatment outcomes for scleroderma

[0131]

[0132] Figures 1-2 It adopts the first experimental group in Table 3 ( Figure 1 ) and Experimental Group 7 ( Figure 2 The image shows a comparison of the effects of topical hot compresses on scleroderma before and after treatment. In the image, A represents before treatment and B represents after treatment. The arrows indicate the locations where the scleroderma symptoms changed significantly.

[0133] It should be noted that when numerical ranges are involved in this invention, it should be understood that the two endpoints of each numerical range, as well as any value between the two endpoints, can be selected. Since the steps and methods used are the same as in the embodiments, preferred embodiments are described in this invention to avoid redundancy. Although preferred embodiments of this invention have been described, those skilled in the art, once they understand the basic inventive concept of this invention, can make other changes and modifications to these embodiments, and all such changes and modifications fall within the scope of this invention.

[0134] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. If such modifications and variations fall within the scope of equivalents of this invention, then this invention also intends to include these modifications and variations.

Claims

1. A topical hot compress for treating scleroderma, characterized in that, Made from the following parts by weight of raw materials: Artemisia argyi 20-40 parts, Cinnamomum cassia 20-40 parts, Sparganium stoloniferum 10-20 parts, Curcuma zedoaria 10-20 parts, Loranthus parasiticus 10-20 parts, Gynostemma pentaphyllum 15-30 parts, Spirodela polyrhiza 10-20 parts, Ephedra sinica 15-30 parts, Clematis chinensis 20-40 parts, Eupolyphaga sinensis 5-15 parts, Acer buergerianum 15-25 parts, Carthamus tinctorius 5-15 parts, Dracaena cochinchinensis 3-6 parts, Strychnos nux-vomica 3-6 parts, Vaccaria segetalis 20-40 parts, Astragalus membranaceus 20-40 parts, Magnolia officinalis 10-20 parts, Aconitum carmichaelii 10-20 parts, Yellow rice wine 22-40 parts.

2. The topical hot compress for treating scleroderma according to claim 1, characterized in that, Made from the following parts by weight of raw materials: 30 parts Artemisia argyi, 30 parts Cinnamomum cassia, 15 parts Sparganium stoloniferum, 15 parts Curcuma zedoaria, 15 parts Rhizoma scutellariae, 20 parts Glehnia littoralis, 15 parts Spirodela polyrhiza, 20 parts Ephedra sinica, 30 parts Clematis chinensis, 10 parts Eupolyphaga sinensis, 20 parts Achyranthes bidentata, 10 parts Carthamus tinctorius, 5 parts Dragon's Blood, 5 parts Prepared Strychnos nux-vomica, 30 parts Vaccaria segetalis, 30 parts Astragalus membranaceus, 15 parts Magnolia officinalis, 15 parts Aconitum carmichaelii, and 33 parts Shaoxing wine.

3. The method for preparing the topical hot compress for treating scleroderma according to claim 1, characterized in that, include: Prepare the raw materials according to their respective weight proportions, mix all the raw materials except for the rice wine, and grind them into a powder of 40-60 mesh. Add rice wine to the medicinal powder, mix to moisten the powder, put it into a cloth bag, heat it, and you will get a topical hot compress for treating scleroderma.

4. The method for preparing the topical hot compress for treating scleroderma according to claim 3, characterized in that, The bag is made of gauze.

5. The method for preparing the topical hot compress for treating scleroderma according to claim 3, characterized in that, The temperature of the heated topical compress is 40℃~48℃.

6. The method for preparing the topical hot compress for treating scleroderma according to claim 3, characterized in that, After being placed in a cloth bag and before heating, a refrigeration step is also included. The refrigeration process is as follows: After the medicine packets are placed in the cloth bag, they are placed in a plastic bag, sealed, and refrigerated at 4℃~10℃ for 1 to 2 days.

7. The method for preparing the topical hot compress for treating scleroderma according to claim 3, characterized in that, When refrigerating, the plastic bag contains refrigerant, which is wrapped around the outside of the medicine bag. After refrigeration, the medicine bag is removed, heated, and used as a topical hot compress. The refrigerant is uncrushed mugwort leaves or safflower.

8. The method for preparing the topical hot compress for treating scleroderma according to claim 7, characterized in that, The amount of refrigerant used per 100g of powder should not exceed 50g.

9. The method for preparing the topical hot compress for treating scleroderma according to claim 7, characterized in that, After refrigeration, punch holes with a diameter of 1mm to 2mm into the bottom surface of the plastic wrap, with no fewer than 3 holes; With the bottom surface of the plastic package facing down, it is heated by steaming and then cooled to 40℃~48℃ to obtain a topical hot compress.

Images