External hot compress agent for treating scleroderma and preparation method thereof

Abstract

The invention belongs to the technical field of skin disease treatment products, and particularly relates to an external hot compress agent for treating scleroderma and a preparation method of the external hot compress agent. The traditional Chinese medicine is prepared from the following raw materials in parts by weight: 20-40 parts of folium artemisiae argyi, 20-40 parts of cassia twig, 10-20 parts of rhizoma sparganii, 10-20 parts of curcuma zedoary, 10-20 parts of centella asiatica, 15-30 parts of loess-doll, 10-20 parts of duckweed, 15-30 parts of ephedra, 20-40 parts of radix clematidis, 5-15 parts of ground beetle, 15-25 parts of turmeric, 5-15 parts of safflower, 3-6 parts of dragon's blood, 3-6 parts of processed semen strychni, 20-40 parts of cowherb seed, 20-40 parts of astragalus membranaceus, 10-20 parts of mangnolia officinalis, 10-20 parts of aconite and 22-40 parts of yellow wine. The traditional Chinese medicine is an external medicine, does not need to be orally taken, treats external diseases by external treatment, is beneficial to the situation, and provides a way for curing pathogenic factors. The trouble of bitter taste of medicines is avoided, and the traditional Chinese medicine composition also has good effects of relieving symptoms of the localized scleroderma and curing the localized scleroderma.

Description

Technical Field

[0001] The present invention belongs to the technical field of skin disease treatment products, and particularly relates to an external hot compress for treating scleroderma and a preparation method thereof. Background Art

[0002] Scleroderma is a connective tissue disease characterized by skin inflammation, degeneration, thickening, and fibrosis, followed by hardening and atrophy. Initially, scleroderma may present with localized or multiple edematous plaques on the skin, accompanied by thickening and hardening of the skin. Symptoms of systemic scleroderma may also include joint pain, muscle atrophy, and esophageal and lung lesions.

[0003] Currently, scleroderma is treated with immunosuppressants such as glucocorticoids and cyclophosphamide tablets. While these can effectively alleviate scleroderma symptoms, they cannot be taken long-term due to significant side effects. For localized skin symptoms, local treatment is more beneficial for recovery.

[0004] There are also some topical preparations for treating scleroderma in the prior art, such as Chinese Patent CN105147788A, which discloses a topical ointment for treating localized scleroderma and a preparation method thereof, and Chinese Patent CN112316205A, which discloses a Centella asiatica ointment, a topical gel dressing, and a preparation method thereof. These topical preparations are applied by rubbing or applying and can be used for a long time, but the therapeutic effect is poor. Summary of the Invention

[0005] To address the above technical problems, the present invention provides a topical hot compress for treating scleroderma and a preparation method thereof, particularly suitable for localized skin diseases. The topical hot compress provided by the present invention is a topical medication that does not require oral administration and effectively treats external diseases, taking advantage of the situation and finding a path to cure the pathogenic factors. This eliminates the need for bitter medication while relieving the symptoms of localized scleroderma and providing a cure, resulting in excellent efficacy.

[0006] The first object of the present invention is to provide an external hot compress for treating scleroderma, which is prepared from the following raw materials in parts by weight: 20 to 40 parts of mugwort leaves, 20 to 40 parts of cassia twigs, 10 to 20 parts of triangularis, 10 to 20 parts of zedoaria, 10 to 20 parts of rhizoma scutellariae, 15 to 30 parts of ginger stone, 10 to 20 parts of duckweed, 15 to 30 parts of ephedra, 20 to 40 parts of clematis, 5 to 15 parts of earthworms, 15 to 25 parts of leaf worms, 5 to 15 parts of safflower, 3 to 6 parts of dragon's blood, 3 to 6 parts of processed strychnine seeds, 20 to 40 parts of fenugreek, 20 to 40 parts of astragalus, 10 to 20 parts of magnolia bark, 10 to 20 parts of aconite, and 22 to 40 parts of yellow rice wine.

[0007] Among them, the effects of each raw material in the present invention are as follows:

[0008] Mugwort, with its light, pungent, and warming properties, is ranked first among yang-warming herbs. It warms the meridians and dispels cold, unblocks the meridians and opens the orifices. It warms Qi and blood, dispels dampness and cold, aids in qi transformation, and softens the skin.

[0009] Cinnamon twig, induces sweating and relieves muscles, warms the meridians, promotes yang to the limbs, and helps yang transform into qi.

[0010] Trillium can break up blood and promote qi circulation, soften hard masses and loosen lumps, and soften the skin.

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

[0012] It is a warming blood-activating herb. It can accelerate fracture healing.

[0013] Jiangshi is a Shaanxi native medicinal material that can promote blood circulation, disperse stagnation, relieve pain, reduce swelling and fight cancer.

[0014] Duckweed is light in texture and can reach the skin, dispel external evil, dredge the meridians and open the orifices.

[0015] Ephedra, which can induce sweating, dispel cold, open up the meridians and orifices, open up the pores and soften the skin.

[0016] Smilax glabra is the best at softening and dispersing lumps, opening up the twelve meridians, promoting blood circulation and unblocking meridians, and softening the skin.

[0017] Earth element can reduce swelling and relieve pain, remove blood stasis and dredge meridians, activate blood circulation and dredge collaterals, soften hard lumps and soften the skin.

[0018] Page worms are good at crawling across the body, and are good at unblocking meridians, breaking up blood and removing blood stasis, reducing swelling and dispersing nodules. They are important medicines for treating accumulation of symptoms, injuries from falls, and skin lumps.

[0019] Safflower warms the yang and invigorates blood circulation, promotes menstruation, dissipates blood stasis and relieves pain.

[0020] Xuejie, promotes blood circulation and relieves pain, resolves blood stasis and stops bleeding, promotes tissue regeneration and heals sores.

[0021] Processed Strychnos nux vomica can promote blood circulation, remove blood stasis, dredge meridians and relieve pain.

[0022] Vaccaria segetalis can open up the twelve meridians, promote blood circulation and remove blood stasis, open the orifices and dredge the meridians, and promote diuresis and reduce swelling.

[0023] Astragalus nourishes Qi and raises Yang, benefits the Wei and strengthens the exterior, promotes diuresis and reduces swelling, promotes fluid production and nourishes blood, and assists Yang and transforms Qi.

[0024] Magnolia officinalis, dries dampness and eliminates phlegm, promotes qi and removes accumulation.

[0025] Aconitum warms the Yang and transforms Qi, unblocks the twelve meridians, dispels cold and relieves pain, and restores Yang and rescues the adverse.

[0026] Yellow wine, the best of all medicines, can open up the twelve meridians, warm the yang and activate blood circulation, dredge the meridians and relieve pain, and play a mediating role.

[0027] The compatibility principle of the external hot compress for treating scleroderma of the present invention is as follows: wormwood leaf, cinnamon twig, aconite root, ephedra, and astragalus root are used as the main ingredients, and their main functions are warming yang and dispelling cold, promoting blood circulation and unblocking the meridians; ginger stone, ephedra, clematis root, earthworm, radix scutellariae, and schizonepeta as the auxiliary ingredients, and their main functions are softening and dispersing hard masses, promoting blood circulation and unblocking the meridians, and softening the skin; and adjuvant ingredients are triangular horn, zedoaria, duckweed, safflower, dragon's blood, processed strychnine seeds, magnolia bark, and yellow rice wine, and their main functions are promoting blood circulation and dispersing blood stasis, softening and dispersing hard masses, and resolving phlegm and resolving stagnation. The main effects of the combination of the ingredients are invigorating qi and warming yang, promoting blood circulation and unblocking the meridians, resolving phlegm and dispersing stagnation, and softening the skin, and the invention has a good effect in treating localized scleroderma, frostbite, and cold sores.

[0028] Preferably, the topical hot compress for treating scleroderma is prepared from the following raw materials in parts by weight after decades of clinical practice and changes in drug compatibility: 30 parts of Artemisia argyi, 30 parts of cinnamon twig, 15 parts of Trigonosciadium japonicum, 15 parts of Curcuma zedoaria, 15 parts of Lodestemon radix, 20 parts of Ligusticum wallichii, 15 parts of Duckweed, 20 parts of Ephedra sinica, 30 parts of Clematidis, 10 parts of Earthworm, 20 parts of Leafworm, 10 parts of Carthamus tinctorius, 5 parts of Sanguisorba officinalis, 5 parts of processed Strychnos nux vomica, 30 parts of Vaccaria segetalis, 30 parts of Astragalus membranaceus, 15 parts of Magnolia officinalis, 15 parts of Aconitum carmichaelii, and 33 parts of Yellow rice wine. This formula has good efficacy and high drug efficiency.

[0029] A second object of the present invention is to provide a method for preparing an external hot compress for treating scleroderma, comprising:

[0030] Prepare the raw materials according to their weight parts, mix the raw materials except the yellow rice wine, and grind them into 40-60 mesh powder;

[0031] Yellow rice wine is added to the medicinal powder, mixed to moisten the medicinal powder, put into a cloth bag, and heated to obtain an external hot compress for treating scleroderma.

[0032] In the above preparation method, the preparation method of the medicine powder is simple, and it is put into a cloth bag with rice wine as the guide, and hot compress is applied. It is easy to use, has very little stickiness on the skin, and is easy to clean after application.

[0033] Preferably, the rice wine is adjusted Ta Pai rice wine, and the alcohol content is adjusted to 15 degrees with edible ethanol.

[0034] Preferably, the cloth bag is made of gauze, which has good air permeability and facilitates the active ingredients in the medicine powder to penetrate into the skin.

[0035] Preferably, the temperature of the heated external hot compress is 40° C. to 48° C. This is a temperature that is acceptable to the human body and is not easily burned, and also helps the active ingredients in the powder to be released and penetrate into the skin.

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

[0037] Prepare the raw materials according to their weight parts, mix them, and grind them into 40-60 mesh powder;

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

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

[0040] The mixture is heated to obtain a hot compress for external use for treating scleroderma.

[0041] In the preparation method of the present invention, the active ingredients in the raw materials are integrated by refrigeration, thereby reducing drug allergy and improving drug efficacy. Preferably, the bag is made of gauze, and the temperature of the external hot compress after heating is 40°C to 48°C.

[0042] Preferably, during refrigeration, a refrigerant is built into the plastic bag, and the refrigerant is wrapped around the outside of the medicine bag. After refrigeration, the medicine bag is taken out and heated to be used as an external hot compress; wherein the refrigerant is uncrushed mugwort or safflower. Mugwort is in the form of leaves, and safflower is in the form of petals. Both are relatively thin and have good volatile components. The existing technology is commonly used to make mugwort essential oil and safflower essential oil. The present invention uses mugwort or petals as a refrigerant, allowing the volatiles in the two to slowly evaporate under low temperature conditions and penetrate into the inside of the medicine bag. Note that it is not stored at high temperature, because under high temperature conditions, the volatiles evaporate too quickly, and only a small amount can remain on the surface of the medicine bag, and most of the volatiles will escape and be wasted.

[0043] Preferably, the amount of the refrigerant used per 100g of the powder is no more than 50g. Preferably, the refrigerant is wrapped in a single layer on the outer surface of the medicine bag.

[0044] Preferably, after refrigeration, the lower surface of the plastic bag is pierced with holes with a diameter of 1mm to 2mm, with the number of holes being no less than 3, such as 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 or 15; the lower surface of the plastic bag is facing downwards, placed in a steamer and heated to 60°C to 65°C, and then cooled to 40°C to 48°C. This method allows water vapor to penetrate into the medicine bag. The reason for heating to 60°C to 65°C first is that the powder inside the medicine bag is not easily heated. It is first heated to a slightly higher temperature and then cooled to 40°C to 48°C to obtain an external hot compress, which is finally used for hot compress. Preferably, a steamer with controllable heating temperature is used to control the heating temperature to 60°C to 65°C, which makes it easy to control the temperature of the external hot compress.

[0045] Scleroderma is characterized by localized coldness, hardening, skin atrophy, and obstructed pores. This results in an absence of sweat and hair loss, making ointments difficult to absorb. The present invention aims to utilize the warmth of the hot compress to open the pores, facilitating drug absorption. This, combined with the combined effects of warming yang, promoting blood circulation, and unblocking meridians, is essential for achieving the desired effect.

[0046] Compared with the prior art, the present invention has at least the following beneficial effects: The main effects of the topical hot compress for treating scleroderma provided by the invention are to invigorate qi and warm yang, activate blood circulation and dredge meridians, resolve phlegm and dissipate stagnation, and soften the skin. It is suitable for treating localized scleroderma, frostbite, and cold sores. The topical hot compress for treating scleroderma provided by the invention is a topical medication and does not require oral administration. Localized scleroderma manifests as localized cooling, hardening, and obstruction of the pores, which prevents conventional ointments or topical preparations from penetrating and absorbing. This ultimately achieves the effect of improving the efficacy of the drug. BRIEF DESCRIPTION OF THE DRAWINGS

[0047] Figure 1 These are pictures of the effects of volunteer 1, A is before treatment, and B is after treatment.

[0048] Figure 2 These are pictures showing the effects of volunteer 2, A is before treatment, and B is after treatment.

[0049] Figure 1 and Figure 2 In the figure, the circled position is the treatment position. DETAILED DESCRIPTION

[0050] In order to enable those skilled in the art to better understand and implement the technical solution of the present invention, the present invention is further described below with reference to specific embodiments and drawings.

[0051] In the prior art, oral medications such as glucocorticoids and cyclophosphamide tablets have significant side effects and cannot be taken long-term. External preparations disclosed in Chinese patents CN105147788A and CN112316205A cannot be absorbed and have poor efficacy. Based on these reasons, the present invention provides an external hot compress for treating scleroderma, which is made from the following raw materials in parts by weight: 20-40 parts of mugwort leaves, 20-40 parts of cassia twigs, 10-20 parts of triangularis, 10-20 parts of zedoaria, 10-20 parts of rhizoma scutellariae, 15-30 parts of ginger stone, 10-20 parts of duckweed, 15-30 parts of ephedra, 20-40 parts of clematis, 5-15 parts of earthworms, 15-25 parts of leaf worms, 5-15 parts of safflower, 3-6 parts of blood clotting, 3-6 parts of processed strychnine seeds, 20-40 parts of fenugreek, 20-40 parts of astragalus, 10-20 parts of magnolia bark, 10-20 parts of aconite, and 22-40 parts of yellow rice wine. The main effects are to invigorate qi and warm yang, promote blood circulation and dredge meridians, resolve phlegm and disperse nodules, and soften the skin. It has good effects in treating localized scleroderma, frostbite, and cold sores.

[0052] Some specific examples and experimental results are provided below to demonstrate the effects of the present invention.

[0053] The yellow rice wine used in each embodiment of the present invention is adjusted Ta Pai yellow rice wine, the type of Ta Pai yellow rice wine is Huadiao wine, item number 8675246354, and the alcohol content of Ta Pai yellow rice wine is adjusted to 15 degrees with edible ethanol to obtain adjusted Ta Pai yellow rice wine. In the following embodiments and experiments, it is referred to as yellow rice wine for later use.

[0054] Example 1

[0055] An external hot compress for treating scleroderma, the formula of which is made from the following raw materials in parts by weight:

[0056] 30 parts of wormwood leaves, 30 parts of cassia twigs, 15 parts of rhizoma trigonidis, 15 parts of zedoariae, 15 parts of rhizoma lobatae, 20 parts of ginger stones, 15 parts of duckweed, 20 parts of ephedra, 30 parts of clematis, 10 parts of earthworms, 20 parts of leaf worms, 10 parts of safflower, 5 parts of dragon's blood, 5 parts of processed strychnine seeds, 30 parts of fenugreek, 30 parts of astragalus, 15 parts of magnolia bark, 15 parts of aconite, and 33 parts of yellow rice wine.

[0057] Example 2

[0058] An external hot compress for treating scleroderma, the formula of which is made from the following raw materials in parts by weight:

[0059] 20 parts of wormwood leaves, 20 parts of cinnamon twigs, 10 parts of trigonosciadium japonicum, 10 parts of zedoaria, 10 parts of rhizoma lobatae, 15 parts of ginger stones, 10 parts of duckweed, 15 parts of ephedra, 20 parts of clematis, 5 parts of earthworms, 15 parts of leaf worms, 5 parts of safflower, 3 parts of dragon's blood, 3 parts of processed strychnine seeds, 20 parts of fenugreek, 20 parts of astragalus, 10 parts of magnolia bark, 10 parts of aconite, and 22 parts of yellow rice wine.

[0060] Example 3

[0061] An external hot compress for treating scleroderma, the formula of which is made from the following raw materials in parts by weight:

[0062] 40 parts of wormwood leaves, 40 parts of cassia twigs, 20 parts of rhizoma trigonidis, 20 parts of zedoariae, 20 parts of rhizoma lobatae, 30 parts of ginger stones, 20 parts of duckweed, 30 parts of ephedra, 40 parts of clematis roots, 15 parts of earthworms, 25 parts of leaf worms, 15 parts of safflower, 6 parts of dragon's blood, 6 parts of processed strychnine seeds, 40 parts of fenugreek leaves, 40 parts of astragalus, 20 parts of magnolia bark, 20 parts of aconite, and 40 parts of yellow rice wine.

[0063] The animal testing methods are as follows:

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

[0065] (2) Test drugs: The external hot compresses for treating scleroderma prepared in each embodiment, and the "Ruanpi Hot Compress Powder" prepared before the present invention, refer to the document: Han Shirong et al., "Experimental Study of External Application of Ruanpi Hot Compress Powder on Localized Scleroderma Model Mice," Chinese Journal of Practical Medical Research, June 2010, Vol. 6, No. 6. The drug composition formula in this document does not disclose the specific raw material weight composition and compatibility relationship. The formula of the present invention is a new formula proposed through continuous clinical observation and summary, which strengthens the ingredients of warming yang, activating blood circulation, unblocking meridians and opening the orifices, and softening the skin.

[0066] (3) Modeling: The specific modeling method refers to the experimental study on the localized scleroderma model mice using the external application of "soft skin hot compress powder" mentioned above.

[0067] (4) Treatment: The skin of healthy BALB / c mice served as a blank control group. Mice that had successfully been modeled without any drug treatment served as a model group. The aforementioned "soft skin hot compress powder" was applied externally to the modeled skin for 26 days, serving as a drug control group. A saline solution was applied as a reagent control group. The topical hot compress of the present invention for treating scleroderma was applied once daily for 30 minutes, with one package used once, serving as an experimental group.

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

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

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

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

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

[0073] Experimental Group 5: Prepare raw materials according to the weight parts of Example 2, mix the raw materials except rice wine, and grind them into 40-mesh powder. Add rice wine to the powder and mix to moisten the powder. Take 2 g and put it into a medical gauze bag, heat it to 40°C, and obtain a hot compress for external use for treating scleroderma.

[0074] Experimental Group 6: Prepare raw materials according to the weight parts of Example 3, mix the raw materials except rice wine, and grind them into 40-mesh powder. Add rice wine to the powder and mix to moisten the powder. Take 2 g and put it into a medical gauze bag, heat it to 40°C, and obtain an external hot compress for treating scleroderma.

[0075] Experimental Group 7: Prepare the raw materials according to the weight parts of Example 1. Mix the raw materials except for the yellow rice wine and grind them into a 40-mesh powder. Add the yellow rice wine to the powder and mix to moisten the powder. Take 2 g and place it in a medical gauze bag. Place it in a plastic bag, seal it, and refrigerate it at 4°C for 1 day. Then, remove the bag and heat it to 40°C to obtain a topical hot compress for treating scleroderma. During refrigeration, a refrigerant is placed inside the plastic bag and wrapped around the outside of the bag. The refrigerant is uncrushed mugwort leaves, and 30 g of the refrigerant is used per 100 g of the powder.

[0076] Experimental Group 8: Prepare the raw materials according to the weight parts of Example 2. Mix the raw materials except for the yellow rice wine and grind them into a 40-mesh powder. Add the yellow rice wine to the powder and mix to moisten the powder. Take 2 g and place it in a medical gauze bag. Place it in a plastic bag, seal it, and refrigerate it at 4°C for 1 day. Then, remove the bag and heat it to 40°C to obtain a topical hot compress for treating scleroderma. During refrigeration, a refrigerant is placed inside the plastic bag and wrapped around the outside of the bag. The refrigerant is uncrushed mugwort leaves, and 30 g of the refrigerant is used for every 100 g of the powder.

[0077] Experimental Group 9: Prepare the raw materials according to the weight parts of Example 3. Mix the raw materials except for the yellow rice wine and grind them into a 40-mesh powder. Add the yellow rice wine to the powder and mix to moisten the powder. Take 2 g and place it in a medical gauze bag. Place it in a plastic bag, seal it, and refrigerate it at 4°C for 1 day. Then, remove the bag and heat it to 40°C to obtain a topical hot compress for treating scleroderma. During refrigeration, a refrigerant is placed inside the plastic bag and wrapped around the outside of the bag. The refrigerant is uncrushed mugwort leaves, and 30 g of the refrigerant is used for every 100 g of the powder.

[0078] Experimental Group 10: Prepare the raw materials according to the weight parts of Example 1. Except for the yellow rice wine, mix the raw materials and grind them into a 40-mesh powder. Add the yellow rice wine to the powder and mix to moisten the powder. Take 2 g and place it in a medical gauze bag. Place it in a plastic bag, seal it, and refrigerate it at 4°C for 1 day. Then, remove the bag and heat it to 40°C to obtain a topical hot compress for treating scleroderma. During refrigeration, a refrigerant is placed inside the plastic bag and wrapped around the outside of the bag. The refrigerant is unground safflower, and 30 g of the refrigerant is used per 100 g of the powder.

[0079] Experimental Group 11: Prepare the raw materials according to the weight parts of Example 2. Except for the yellow rice wine, mix the raw materials and grind them into a 40-mesh powder. Add the yellow rice wine to the powder and mix to moisten the powder. Take 2 g and place it in a medical gauze bag. Place it in a plastic bag, seal it, and refrigerate it at 4°C for 1 day. Then, remove the bag and heat it to 40°C to obtain a topical hot compress for treating scleroderma. During refrigeration, a refrigerant is placed inside the plastic bag and wrapped around the outside of the bag. The refrigerant is unground safflower, and 30 g of the refrigerant is used per 100 g of the powder.

[0080] Experimental Group 12: Prepare the raw materials according to the weight parts of Example 3. Except for the yellow rice wine, mix the raw materials and grind them into a 40-mesh powder. Add the yellow rice wine to the powder and mix to moisten the powder. Take 2 g and place it in a medical gauze bag. Place it in a plastic bag, seal it, and refrigerate it at 4°C for 1 day. Then, remove the bag and heat it to 40°C to obtain a topical hot compress for treating scleroderma. During refrigeration, a refrigerant is placed inside the plastic bag and wrapped around the outside of the bag. The refrigerant is unground safflower, and 30 g of the refrigerant is used per 100 g of the powder.

[0081] Experimental Group 13: Prepare the raw materials according to the weight parts of Example 1. Except for the rice wine, mix the raw materials and grind them into a 40-mesh powder. Add the rice wine to the powder and mix until the powder is moistened. Take 2g of the powder and place it in a medical gauze bag. Place it in a sealed plastic bag and refrigerate at 4°C for 1 day. During refrigeration, the plastic bag contains a refrigerant (unground mugwort leaves) wrapped around the outside of the bag. The refrigerant is 30g per 100g of powder. After refrigeration, pierce the bottom surface of the plastic bag with 1mm diameter holes, with 10 holes in total. Heat the bag in a steamer to 60°C and then cool it to 40°C.

[0082] Experimental Group 14: Prepare the ingredients according to the weight portion of Example 2. Except for the rice wine, mix the ingredients and grind them into a 40-mesh powder. Add the rice wine to the powder and mix until the powder is moistened. Take 2g of the powder and place it in a medical gauze bag. Place it in a sealed plastic bag and refrigerate at 4°C for 1 day. During refrigeration, the plastic bag contains a refrigerant (unground mugwort leaves) wrapped around the outside of the bag. The refrigerant is 30g per 100g of powder. After refrigeration, pierce the bottom surface of the plastic bag with 1mm diameter holes, 10 in total. Heat the bag in a steamer to 60°C, then cool to 40°C.

[0083] Experimental Group 15: Prepare the raw materials according to the weight parts of Example 3. Except for the rice wine, mix the raw materials and grind them into a 40-mesh powder. Add the rice wine to the powder and mix until the powder is moistened. Take 2g of the powder and place it in a medical gauze bag. Place it in a sealed plastic bag and refrigerate at 4°C for 1 day. During refrigeration, the plastic bag contains a refrigerant (unground mugwort leaves) wrapped around the outside of the bag. The refrigerant is 30g per 100g of powder. After refrigeration, pierce the bottom surface of the plastic bag with 1mm diameter holes, 10 in total. Heat the bag in a steamer to 60°C, then cool it to 40°C.

[0084] (5) Skin thickness analysis results.

[0085] The results of skin thickness analysis are shown in Table 1. Skin thickness analysis is an intuitive therapeutic effect of animal experiments. As can be seen from the results in Table 1, the therapeutic effects of experimental groups 1 to 15 of the present invention are better than those of other groups.

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

[0087] Grouping Number of experimental mice 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) Antibacterial test results

[0089] Since scleroderma may also be associated with fungal infection, we evaluated the antibacterial effects of different drugs. The drug settings for the experimental group are as follows:

[0090] Blank group: sterile distilled water.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[0107] The test strains were ATCC36347 Thermomyces spore-trichol standard strain and ATCC34921 filamentous fungus. The above drugs were added to the bacterial solution, and the original live bacterial concentration of the bacterial solution was 10 8 cfu / mL, add 1g of drug per 100mL of bacterial solution. After 20 minutes, count the viable bacterial concentration in the bacterial solution again and calculate the inhibition rate.

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

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

[0110]

[0111] The results showed that the external hot compress for treating scleroderma prepared by the present invention had an obvious antibacterial effect, which was close to 100%.

[0112] (7) Clinical treatment methods and effects

[0113] 1. 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: Sclerotic changes proximal to the metacarpophalangeal joints, which may involve the entire limbs, face, body, and trunk.

[0116] (2) Minor criteria: digital scleroderma, the above-mentioned skin changes are limited to the fingers; there are depressed scars on the fingertips and disappearance of the finger pads; bilateral basilar fibrosis.

[0117] (3) Other manifestations that are helpful for diagnosis: Raynaud's phenomenon, polyarthritis or joint pain, esophageal motility abnormalities, skin pathology collagen fiber swelling and fibrosis, etc.

[0118] Please note that the above clinical diagnostic criteria are based on the indicators currently used in actual clinical diagnostic activities, including but not limited to the above-mentioned major criteria, minor criteria or other manifestations that are helpful for diagnosis.

[0119] 2. Patient inclusion

[0120] Scleroderma patients, 100 cases in each group, half male and half female, aged 20 to 55 years.

[0121] III. Criteria for determining efficacy

[0122] Recovery: The lesioned part returns to normal, the skin becomes soft, and only mild pigmentation or atrophy remains.

[0123] Markedly effective: More than 50% of the lesioned area returned to normal, the skin gradually softened, and the clinical symptoms were significantly alleviated.

[0124] Effective: The skin lesions were partially improved, the skin sclerosis was improved, and the clinical symptoms were improved.

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

[0126] 4. External hot compress

[0127] Because clinical cases are difficult to obtain, and according to the experimental results in Table 1, experimental groups 1 to 3 have comparable effects, and experimental groups 7 to 12 have comparable effects, for the sake of sample size and cost, the present invention selected experimental groups 1, 4, and 7 to prepare a topical hot compress for treating scleroderma as a topical hot compress for clinical treatment. Due to the complex preparation plan, experimental groups 13 to 15 were not used in the clinical trial process of the present invention.

[0128] 5. Treatment Plan

[0129] Take 50g twice daily. Apply a hot compress for 30 minutes, using an infrared heating device to maintain warmth. Continue treatment for 5 months.

[0130] Table 3 Statistics of scleroderma treatment results

[0131]

[0132] Figures 1 and 2 The first experimental group ( Figure 1 ) and experimental group 7 ( Figure 2 ) external hot compress, a comparison chart of the effects before and after treatment of scleroderma, where A is before treatment and B is after treatment, and the arrows point to the locations where the scleroderma symptoms change significantly before and after.

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

[0134] Obviously, those skilled in the art may make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. If these modifications and variations of the present invention fall within the scope of the equivalent technology of the present invention, the present invention is intended to include these modifications and variations.

Claims

1. An external hot compress for treating scleroderma, characterized in that: Made from the following raw materials in parts by weight: 20-40 parts of mugwort leaves, 20-40 parts of cassia twigs, 10-20 parts of triangularis, 10-20 parts of curcuma, 10-20 parts of rhizoma rutaecarpa, 15-30 parts of ginger stone, 10-20 parts of duckweed, 15-30 parts of ephedra, 20-40 parts of clematis, 5-15 parts of earthworms, 15-25 parts of leaf worms, 5-15 parts of safflower, 3-6 parts of blood clotting, 3-6 parts of processed strychnos nux vomica, 20-40 parts of fenugreek, 20-40 parts of astragalus, 10-20 parts of magnolia bark, 10-20 parts of aconite, and 22-40 parts of rice wine.

2. The external hot compress for treating scleroderma according to claim 1, characterized in that: Made from the following raw materials in parts by weight: 30 parts of wormwood leaves, 30 parts of cassia twigs, 15 parts of trigonosciadium japonicum, 15 parts of curcuma zedoaria, 15 parts of rhizoma scutellariae, 20 parts of ginger stones, 15 parts of duckweed, 20 parts of ephedra, 30 parts of clematis, 10 parts of earthworms, 20 parts of leaf worms, 10 parts of safflower, 5 parts of blood clotting, 5 parts of processed strychnos nux vomica, 30 parts of fenugreek, 30 parts of astragalus, 15 parts of magnolia bark, 15 parts of aconite, and 33 parts of yellow rice wine.

3. The method for preparing the external hot compress for treating scleroderma according to claim 1, characterized in that: include: Prepare raw materials according to weight parts, mix the raw materials except rice wine, and grind into 40-60 mesh powder; Yellow wine is added to the medicinal powder, mixed to moisten the medicinal powder, put into a cloth bag, and heated to obtain an external hot compress for treating scleroderma.

4. The method for preparing the external hot compress for treating scleroderma according to claim 3, characterized in that: The material of the cloth bag is gauze.

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

6. The method for preparing the external hot compress for treating scleroderma according to claim 3, characterized in that: After putting into the bag and before heating, there is also a refrigeration step, and the refrigeration operation method is as follows: After being packed into the cloth bag, the medicine bag is placed in a plastic packaging bag, sealed, and refrigerated at 4℃~10℃ for 1 to 2 days.

7. The method for preparing the external hot compress for treating scleroderma according to claim 3, characterized in that: During refrigeration, a refrigerant is built into the plastic bag, and the refrigerant is wrapped around the outside of the medicine bag. After refrigeration, the medicine bag is taken out and heated to be used as an external hot compress. Wherein, the refrigerant is uncrushed mugwort leaves or safflower.

8. The method for preparing the external hot compress for treating scleroderma according to claim 7, characterized in that: The amount of refrigerant used shall not exceed 50g for every 100g of medicinal powder.

9. The method for preparing the external hot compress for treating scleroderma according to claim 7, characterized in that: After refrigeration, poke holes with a diameter of 1 mm to 2 mm on the lower surface of the plastic bag, with the number of holes being no less than 3; The lower surface of the plastic bag faces downward, and after steaming, it is cooled to 40°C to 48°C to obtain an external hot compress.

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