A traditional Chinese medicine composition for skin wet itching, and a preparation method and application thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine composition, and particularly relates to a traditional Chinese medicine composition for skin wet itching and a preparation method and application thereof.The traditional Chinese medicine composition comprises the following raw medicinal materials: Cnidium, Cusparia, Fructus, Vitis, Calophyllum, Giant Knotweed, Purple Violet, Semen Euphorbiae, Polygonum, Chinese wormwood, Atractylodes, Bamboo Leaf Pepper, Pinus, Myrrh and Sophora alopecuroides.The present application is composed of pure traditional Chinese medicine, and has good local safety and tolerance through pharmacology and toxicology verification, avoids common adverse reactions such as skin atrophy, pigmentation and hormone dependence caused by glucocorticoid external medicine, and is particularly suitable for chronic eczema, dermatitis and pruritus patients who need long-term drug management.The dosage form is represented by an ointment, and the external preparation has good spreading property, long-lasting drug release, and skin protection function, and can effectively improve the skin barrier function of the skin lesion area.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, and in particular to a traditional Chinese medicine composition for treating itchy skin, its preparation method and application. Background Technology

[0002] Eczema, dermatitis, tinea, and pruritus are the most common itchy skin diseases in clinical practice, characterized by high incidence, prolonged course, and recurrent flare-ups, severely impacting patients' quality of life. These diseases are mainly manifested by itching, erythema, papules, exudation, and lichenification. Traditional Chinese medicine often categorizes them under "wet sores" or "infiltrating sores," believing their pathogenesis is related to internal damp-heat, external invasion of wind-damp-heat pathogens, and disharmony of qi and blood. Currently, the treatment cycle for common itchy skin diseases is long and prone to recurrence, placing a heavy physical and mental burden and economic pressure on patients and their families.

[0003] Currently, clinical medications for treating pruritic skin diseases such as eczema and dermatitis are mainly divided into two categories: chemical drugs and traditional Chinese medicine. Chemical drug treatment primarily involves antihistamines, corticosteroid creams, and immunosuppressants. While these can relieve itching and control inflammation in the short term, long-term use can easily lead to adverse reactions such as skin atrophy, pigmentation, hormone dependence, and secondary infections. Topical corticosteroids are highly effective in controlling acute symptoms, but the relapse rate is high after discontinuation, and they are not suitable for long-term, large-area use. Regarding traditional Chinese medicine treatment, oral decoctions require gastrointestinal absorption, have a slow onset of action, and some patients have poor compliance due to long treatment courses and unpleasant taste. Therefore, there is an urgent need to develop a topical preparation that is directly effective, highly safe, and less likely to cause dependence to meet the clinical needs for long-term management of pruritic skin diseases.

[0004] Traditional Chinese medicine (TCM) topical preparations have a long history of treating skin diseases, offering advantages such as direct action, minimal side effects, and avoidance of the first-pass effect in the liver. Ointments, as one of the main dosage forms for transdermal drug delivery, are characterized by good spreadability, long-lasting drug release, and protective and moisturizing effects on the affected skin, making them particularly suitable for treating chronic and subacute skin diseases. In recent years, TCM topical ointments have seen rapid development in the field of skin disease treatment, with several varieties such as Binghuang Fule Ointment, Wudai Ointment, and Compound Kushen Antipruritic Ointment already in clinical use, demonstrating good anti-inflammatory, antipruritic, and antibacterial effects. However, existing TCM topical ointments still have shortcomings, including limited ingredient combinations, single efficacy, and limited effectiveness against complex skin lesions with both dampness and heat. Furthermore, some products use only water or alcohol extraction processes, failing to fully extract the effective components from the medicinal materials, thus affecting the overall efficacy of the preparation. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition for treating itchy skin, its preparation method, and its application.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a traditional Chinese medicine composition for treating itchy skin, comprising the following raw materials in the indicated weight proportions: 60-80 parts of Cnidium monnieri, 40-60 parts of Coptis chinensis, 40-60 parts of Toona sinensis bark, 50-80 parts of Pseudolarix amabilis bark, 30-50 parts of Brucea javanica, 80-100 parts of Polygonum cuspidatum, 80-100 parts of Viola yedoensis, 60-90 parts of Kochia scoparia, 15-25 parts of Polygonum aviculare, 20-30 parts of Artemisia capillaris, 30-40 parts of Atractylodes lancea, 20-30 parts of Zanthoxylum bungeanum, 15-25 parts of Pinus massoniana, 5-10 parts of Commiphora myrrha, and 30-50 parts of Sophora flavescens.

[0007] Preferably, the product also includes the following excipients in parts by weight: 230-270 parts petrolatum, 100-120 parts cetyl alcohol, 8-18 parts sodium lauryl sulfate, 150-180 parts glycerin, and 1-3 parts ethylparaben.

[0008] This invention provides a method for preparing the traditional Chinese medicine composition, comprising the following steps: (a) Take bitter beans, place them in a dry distillation kettle, heat them, and evacuate the air to make the vacuum pressure not lower than 0.02 MPa. When the furnace temperature rises to 180-200℃, carry out heat preservation dry distillation and collect the distilled oil to obtain bitter bean dry distilled oil. (b) Take Viola yedoensis and Polygonum cuspidatum, add ethanol solution for percolation extraction, collect the percolate, recover the ethanol until there is no alcohol odor, concentrate under reduced pressure to obtain alcohol extract; (c) Take the remaining raw materials except for bitter bean seed, violet and Japanese knotweed, decoct with water 2 to 3 times, combine the extracts, filter, concentrate under reduced pressure to obtain water extract. (d) Combine the alcohol extract from step (b) with the water extract from step (c), mix well, and concentrate to obtain the total extract; (e) Heat petrolatum, cetyl alcohol, and glycerin to 75-85°C to melt, add sodium dodecyl sulfate and ethylparaben, stir to dissolve, and use as the oil phase; (f) Heat the total extract from step (d) to 75–85°C as the aqueous phase; (g) Add the aqueous phase slowly to the oil phase while stirring, emulsify evenly, and cool to 40-50°C; (h) Add the bitter bean dry distilled oil from step (a) and stir well to obtain the final product.

[0009] Preferably, in step (b) during percolation extraction, the amount of ethanol solution used is 6 to 10 times the total weight of Viola yedoensis and Polygonum cuspidatum, and the percolation rate is 1 to 3 mL per minute.

[0010] Preferably, the volume concentration of the ethanol solution in step (b) is 60% to 70%.

[0011] Preferably, in step (c), the amount of water added each time is 6 to 12 times the total weight of the medicinal materials, and the decoction time is 1 to 2 hours each time.

[0012] Preferably, the relative density of the total extract in step (d) at 60°C is 1.20 to 1.25.

[0013] Preferably, the emulsification speed in step (g) is 2000~10000 rpm; Preferably, after the stirring in step (h) is uniform, the material is further subjected to colloid milling treatment, and the particle size of the material after grinding is 2~40μm.

[0014] This invention provides the application of the traditional Chinese medicine composition described above or the traditional Chinese medicine composition prepared by the preparation method in the preparation of medicaments for treating eczema, dermatitis, tinea, or pruritus.

[0015] Preferably, the type of drug is a cream, gel, lotion, liniment, tincture, spray, or patch.

[0016] This invention provides an ointment preparation for treating eczema, dermatitis, tinea, or pruritus, made from the traditional Chinese medicine composition described above or the traditional Chinese medicine composition prepared by the preparation method described above.

[0017] This formula focuses on the core effects of "clearing heat and drying dampness, dispelling wind and relieving itching, cooling blood and detoxifying, and promoting wound healing and tissue regeneration." The formula design closely addresses the core pathogenesis of pruritus dermatitis and other itchy skin diseases, namely "internal damp-heat, external invasion of wind-damp-heat pathogens, and disharmony of qi and blood." In this formula, Cnidium monnieri, Kochia scoparia, and Atractylodes lancea dispel wind and dry dampness, relieve itching, and kill parasites, thus eliminating external pathogens. Coptis chinensis, Ailanthus altissima bark, Pseudolarix amabilis bark, and Sophora flavescens clear heat and dry dampness, detoxify, and kill parasites, directly addressing the symptoms of damp-heat. Polygonum cuspidatum, Viola yedoensis, and Brucea javanica cool blood, detoxify, invigorate blood circulation, and remove blood stasis, while also clearing heat toxins from the blood. Pineapple, Zanthoxylum bungeanum, Polygonum aviculare, and Artemisia capillaris clear heat and promote diuresis, guiding pathogens downwards so that dampness is eliminated through urination. Myrrh invigorates blood circulation, relieves pain, promotes wound healing, and promotes tissue regeneration, thus promoting skin lesion repair. The herbs in the entire formula complement each other, dispelling external pathogens and clearing internal pathogens, addressing both the root cause and symptoms, and achieving the combined effect of eliminating pathogens and supporting the body's resistance.

[0018] From a mechanism of action perspective, the herbs in this formula target five pathological aspects: dampness, heat, wind, toxins, and blood stasis, providing multi-target intervention. Cnidium monnieri, Atractylodes lancea, and Kochia scoparia dispel wind and relieve itching, alleviating the patient's most painful primary symptom. Coptis chinensis, Ailanthus altissima bark, Pseudolarix amabilis bark, Sophora flavescens seed, Artemisia capillaris, Polygonum aviculare, and Pinus massoniana clear heat, promote diuresis, and detoxify, eliminating the causes of exudation and spread of skin lesions. Polygonum cuspidatum, Viola yedoensis, and Brucea javanica cool the blood and detoxify, controlling the inflammatory response of local erythema and burning. Myrrh invigorates blood circulation, removes blood stasis, promotes wound healing, and improves chronic lichenification and rough, thickened skin. These five groups of herbs work synergistically to rapidly control acute itching and inflammation while also focusing on repairing the skin barrier and improving the microenvironment in the chronic phase, forming a complete treatment chain from symptom relief to etiological elimination and tissue repair.

[0019] The principal herbs in this formula are Coptis chinensis, Toona sinensis bark, Pseudolarix amabilis bark, and Cnidium monnieri. Coptis chinensis, Toona sinensis bark, and Pseudolarix amabilis bark are bitter and cold, effectively clearing damp-heat and fire toxins, and are the core of eliminating the cause of the disease. Cnidium monnieri is pungent and warm, dispelling wind, relieving itching, drying dampness, and killing parasites. When combined with the bitter and cold herbs, the combination of cold and warm herbs enhances the effect of drying dampness and relieving itching, while preventing the bitter and cold herbs from being too strong and suppressing the pathogenic factors. The assistant herbs are Polygonum cuspidatum, Viola yedoensis, Brucea javanica, and Kochia scoparia, which assist the principal herbs in enhancing the effects of cooling blood, detoxifying, clearing heat, and promoting diuresis. Among them, Polygonum cuspidatum and Viola yedoensis clear heat toxins in the blood, while Brucea javanica and Kochia scoparia help the principal herbs kill parasites, relieve itching, clear heat, and promote diuresis. The adjuvant herbs are Atractylodes lancea, Artemisia capillaris, Polygonum aviculare, Pinus massoniana, Zanthoxylum bungeanum, and Sophora flavescens. Atractylodes lancea dries dampness, strengthens the spleen, and dispels wind. Artemisia capillaris, Polygonum aviculare, and Pinus massoniana promote diuresis, reduce jaundice, and guide heat downwards. Zanthoxylum bungeanum and Sophora flavescens assist the principal herbs in drying dampness, killing parasites, clearing heat, and relieving pain. These herbs work together to support the principal and assistant herbs, addressing concurrent symptoms and preventing the lingering of damp-heat pathogens. Myrrh is the guiding herb, which invigorates blood, relieves pain, reduces swelling, and promotes tissue regeneration, guiding the other herbs directly to the affected area and promoting skin lesion healing. The entire formula is well-structured, with clear distinctions between the principal and assistant herbs, forming a formula that clears heat and dries dampness, dispels wind and relieves itching, cools the blood and detoxifies, and promotes wound healing and tissue regeneration.

[0020] Compared with the prior art, the present invention has the following beneficial effects: The beneficial effects of the traditional Chinese medicine composition provided by this invention are primarily reflected in its comprehensive coverage and precise intervention of the core pathogenesis of skin itching. Targeting the complex etiologies of eczema, dermatitis, and other diseases characterized by "internal damp-heat, external invasion of wind-damp-heat pathogens, and disharmony of qi and blood," the formulation breaks through the conventional approach of simply clearing heat or dispelling wind and relieving itching. Its core effects are clearing heat and drying dampness, dispelling wind and relieving itching, cooling blood and detoxifying, promoting blood circulation and removing blood stasis, and promoting tissue regeneration and wound healing, achieving a complete treatment process from eliminating pathogenic factors and alleviating clinical symptoms to repairing damaged tissue. Compared to the limitations of existing products that often focus on immediate itch relief or short-term anti-inflammatory effects, this invention can simultaneously address complex skin lesions such as acute exudative redness and swelling as well as chronic infiltrative thickening, expanding the breadth of indications and the depth of treatment for topical traditional Chinese medicine preparations.

[0021] Secondly, this invention, through an innovative step-by-step preparation process, maximizes the preservation of the activity of active ingredients with different polarities. The lipophilic antipruritic and anti-inflammatory components of *Bletilla striata* are obtained using dry distillation; flavonoids, anthraquinones, and other blood-cooling and detoxifying components are enriched using percolate extraction from *Viola yedoensis* and *Polygonum cuspidatum*; and the remaining herbs are extracted by decoction to obtain the more polar heat-clearing and dampness-draining medicinal substances. By combining the strengths of each method and proceeding in parallel, this approach avoids the omission or destruction of components with different properties caused by a single extraction method, while ensuring a complete range and sufficient content of active substances in the final ointment. This gives the composition the clinical characteristics of rapid, efficient, and long-lasting effects, demonstrating significant advantages in terms of antipruritic onset time, duration of efficacy, and overall symptom improvement.

[0022] Furthermore, the entire formula of this invention is composed of pure traditional Chinese medicine, and pharmacological and toxicological studies have verified its good local safety and tolerability. It avoids common adverse reactions caused by topical corticosteroids, such as skin atrophy, pigmentation, and hormone dependence, making it particularly suitable for patients with chronic eczema, dermatitis, and pruritus requiring long-term medication management. Its dosage form is designed as a topical preparation, primarily an ointment. Such preparations have good spreadability, long-lasting drug release, and moisturizing and protective functions, effectively improving the skin barrier function in the affected area. This invention provides a new treatment option with definite efficacy, high safety, and good compliance for patients with refractory and recurrent pruritus skin diseases, and has promising clinical application prospects. Detailed Implementation

[0023] The technical solutions provided by the present invention will be described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0024] Example 1

[0025] A traditional Chinese medicine composition for treating itchy skin is made from the following raw materials in the indicated weight proportions: 80 parts of Cnidium monnieri, 60 parts of Coptis chinensis, 60 parts of Toona sinensis bark, 80 parts of Pseudolarix amabilis bark, 50 parts of Brucea javanica, 100 parts of Polygonum cuspidatum, 100 parts of Viola yedoensis, 90 parts of Kochia scoparia, 25 parts of Polygonum aviculare, 30 parts of Artemisia capillaris, 40 parts of Atractylodes lancea, 30 parts of Zanthoxylum bungeanum, 25 parts of Pinus massoniana, 10 parts of Commiphora myrrha, and 50 parts of Sophora flavescens.

[0026] The excipients include: 270 parts petrolatum, 120 parts cetyl alcohol, 18 parts sodium lauryl sulfate, 180 parts glycerin, and 3 parts ethylparaben.

[0027] Its preparation method includes the following steps: (a) Take bitter beans, place them in a dry distillation kettle, heat them, and evacuate the air to make the vacuum pressure value 0.05MPa. When the furnace temperature rises to 200℃, keep it at the temperature for 6 hours and collect the distilled oil to obtain bitter bean dry distilled oil. (b) Take Viola yedoensis and Polygonum cuspidatum, add 10 times their total weight of 70% ethanol solution for percolation extraction at a rate of 3 mL per minute, collect the percolate, recover the ethanol until there is no alcohol odor, concentrate under reduced pressure to obtain ethanol extract. (c) Take the remaining raw materials except for bitter bean, violet and Japanese knotweed, add water and decoct three times, each time adding water 12 times the total weight of the medicinal materials, decoct for 2 hours each time, combine the extracts, filter, concentrate under reduced pressure to obtain water extract. (d) Combine the alcohol extract from step (b) with the water extract from step (c), mix well, and concentrate to a total extract with a relative density of 1.25 at 60°C. (e) Heat petrolatum, cetyl alcohol, and glycerin to 85°C to melt, add sodium dodecyl sulfate and ethylparaben, stir to dissolve, and use as the oil phase; (f) Heat the total extract from step (d) to 85°C as the aqueous phase; (g) Add the aqueous phase slowly to the oil phase while stirring, emulsify (2000 rpm) until uniform, and cool to 50°C; (h) Add the bitter bean dry distilled oil from step (a), stir well, and pass it through a colloid mill (the average particle size after grinding is 30μm) to obtain the product.

[0028] Example 2

[0029] A traditional Chinese medicine composition for treating itchy skin is made from the following raw materials in the indicated weight ratios: 60 parts of Cnidium monnieri, 40 parts of Coptis chinensis, 40 parts of Toona sinensis bark, 50 parts of Pseudolarix amabilis bark, 30 parts of Brucea javanica, 80 parts of Polygonum cuspidatum, 80 parts of Viola yedoensis, 60 parts of Kochia scoparia, 15 parts of Polygonum aviculare, 20 parts of Artemisia capillaris, 30 parts of Atractylodes lancea, 20 parts of Zanthoxylum bungeanum, 15 parts of Pinus massoniana, 5 parts of Commiphora myrrha, and 30 parts of Sophora flavescens.

[0030] The excipients include: 230 parts petrolatum, 100 parts cetyl alcohol, 8 parts sodium lauryl sulfate, 150 parts glycerin, and 1 part ethylparaben.

[0031] Its preparation method includes the following steps: (a) Take bitter beans, place them in a dry distillation kettle, heat them, and evacuate the air to make the vacuum pressure value 0.03 MPa. When the furnace temperature rises to 180°C, keep it at the temperature for 2 hours and collect the distilled oil to obtain bitter bean dry distilled oil. (b) Take Viola yedoensis and Polygonum cuspidatum, add 6 times their total weight of 60% ethanol solution for percolation extraction at a rate of 1 mL per minute, collect the percolate, recover the ethanol until there is no alcohol odor, concentrate under reduced pressure to obtain ethanol extract. (c) Take the remaining raw materials except for bitter bean, violet and Japanese knotweed, add water and decoct twice, each time adding water to 6 times the total weight of the medicinal materials, decoct for 1 hour each time, combine the extracts, filter, concentrate under reduced pressure to obtain water extract. (d) Combine the alcohol extract from step (b) with the water extract from step (c), mix well, and concentrate to a total extract with a relative density of 1.20 at 60°C. (e) Heat petrolatum, cetyl alcohol, and glycerin to 75°C to melt, add sodium dodecyl sulfate and ethylparaben, stir to dissolve, and use as the oil phase; (f) Heat the total extract from step (d) to 75°C as the aqueous phase; (g) Add the aqueous phase slowly to the oil phase while stirring, emulsify (6000 rpm) until uniform, and cool to 40°C; (h) Add the bitter bean dry distilled oil from step (a), stir well, and pass it through a colloid mill (the average particle size after grinding is 20μm) to obtain the product.

[0032] Example 3

[0033] A traditional Chinese medicine composition for treating itchy skin is made from the following raw materials in the indicated weight ratios: 72 parts of Cnidium monnieri, 48 parts of Coptis chinensis, 55 parts of Toona sinensis bark, 65 parts of Pseudolarix amabilis bark, 38 parts of Brucea javanica, 88 parts of Polygonum cuspidatum, 92 parts of Viola yedoensis, 75 parts of Kochia scoparia, 18 parts of Polygonum aviculare, 24 parts of Artemisia capillaris, 35 parts of Atractylodes lancea, 26 parts of Zanthoxylum bungeanum, 20 parts of Pinus massoniana, 7 parts of Commiphora myrrha, and 42 parts of Sophora flavescens.

[0034] The excipients include: 250 parts petrolatum, 108 parts cetyl alcohol, 12 parts sodium lauryl sulfate, 162 parts glycerin, and 2 parts ethylparaben.

[0035] Its preparation method includes the following steps: (a) Take bitter beans, place them in a dry distillation kettle, heat them, and evacuate the air to make the vacuum pressure value 0.04 MPa. When the furnace temperature rises to 190°C, keep it at the temperature for 4 hours and collect the distilled oil to obtain bitter bean dry distilled oil. (b) Take Viola yedoensis and Polygonum cuspidatum, add 7 times their total weight of 62% ethanol solution for percolation extraction at a rate of 1.5 mL per minute, collect the percolate, recover the ethanol until there is no alcohol odor, concentrate under reduced pressure to obtain ethanol extract. (c) Take the remaining raw materials except for bitter bean, violet and Japanese knotweed, add water and decoct twice, each time adding water to 8 times the total weight of the medicinal materials, decoct for 1.5 hours each time, combine the extracts, filter, concentrate under reduced pressure to obtain water extract. (d) Combine the alcohol extract from step (b) with the water extract from step (c), mix well, and concentrate to a total extract with a relative density of 1.22 at 60°C. (e) Heat petrolatum, cetyl alcohol, and glycerin to 78°C to melt, add sodium dodecyl sulfate and ethylparaben, stir to dissolve, and use as the oil phase; (f) Heat the total extract from step (d) to 80°C as the aqueous phase; (g) Add the aqueous phase slowly to the oil phase while stirring, emulsify (10,000 rpm) until uniform, and cool to 44°C; (h) Add the bitter bean dry distilled oil from step (a), stir well, and pass it through a colloid mill (the average particle size after grinding is 10μm) to obtain the product.

[0036] Example 4

[0037] A traditional Chinese medicine composition for treating itchy skin is made from the following raw materials in the indicated weight proportions: 76 parts of Cnidium monnieri, 55 parts of Coptis chinensis, 48 ​​parts of Toona sinensis bark, 72 parts of Pseudolarix amabilis bark, 45 parts of Brucea javanica, 95 parts of Polygonum cuspidatum, 85 parts of Viola yedoensis, 80 parts of Kochia scoparia, 22 parts of Polygonum aviculare, 28 parts of Artemisia capillaris, 38 parts of Atractylodes lancea, 23 parts of Zanthoxylum bungeanum, 22 parts of Pinus massoniana, 9 parts of Commiphora myrrha, and 46 parts of Sophora flavescens.

[0038] The excipients include: 260 parts petrolatum, 115 parts cetyl alcohol, 15 parts sodium lauryl sulfate, 172 parts glycerin, and 2.5 parts ethylparaben.

[0039] Its preparation method includes the following steps: (a) Take bitter beans, place them in a dry distillation kettle, heat them, and evacuate the air to make the vacuum pressure value 0.045 MPa. When the furnace temperature rises to 195°C, keep it at the temperature for 5 hours and collect the distilled oil to obtain bitter bean dry distilled oil. (b) Take Viola yedoensis and Polygonum cuspidatum, add 9 times their total weight of 68% ethanol solution for percolation extraction at a rate of 2.5 mL per minute, collect the percolate, recover the ethanol until there is no alcohol odor, concentrate under reduced pressure to obtain ethanol extract. (c) Take the remaining raw materials except for bitter bean, violet and Japanese knotweed, add water and decoct three times, each time adding water 10 times the total weight of the medicinal materials, decoct for 1.8 hours each time, combine the extracts, filter, concentrate under reduced pressure to obtain water extract. (d) Combine the alcohol extract from step (b) with the water extract from step (c), mix well, and concentrate to a total extract with a relative density of 1.24 at 60°C. (e) Heat petrolatum, cetyl alcohol, and glycerin to 82°C to melt, add sodium dodecyl sulfate and ethylparaben, stir to dissolve, and use as the oil phase; (f) Heat the total extract from step (d) to 82°C as the aqueous phase; (g) Add the aqueous phase slowly to the oil phase while stirring, emulsify (8000 rpm) until uniform, and cool to 48°C; (h) Add the bitter bean dry distilled oil from step (a), stir well, and pass it through a colloid mill (the average particle size after grinding is 10μm) to obtain the product.

[0040] Example 5

[0041] A traditional Chinese medicine composition for treating itchy skin is made from the following raw materials in the indicated weight ratios: 70 parts of Cnidium monnieri, 50 parts of Coptis chinensis, 50 parts of Toona sinensis bark, 65 parts of Pseudolarix amabilis bark, 40 parts of Brucea javanica, 90 parts of Polygonum cuspidatum, 90 parts of Viola yedoensis, 75 parts of Kochia scoparia, 20 parts of Polygonum aviculare, 25 parts of Artemisia capillaris, 35 parts of Atractylodes lancea, 25 parts of Zanthoxylum bungeanum, 20 parts of Pinus massoniana, 7.5 parts of Commiphora myrrha, and 40 parts of Sophora flavescens.

[0042] The excipients include: 250 parts petrolatum, 110 parts cetyl alcohol, 13 parts sodium lauryl sulfate, 165 parts glycerin, and 2 parts ethylparaben.

[0043] Its preparation method includes the following steps: (a) Take bitter beans, place them in a dry distillation kettle, heat them, and evacuate the air to make the vacuum pressure value 0.04 MPa. When the furnace temperature rises to 190°C, keep it at the temperature for 4 hours and collect the distilled oil to obtain bitter bean dry distilled oil. (b) Take Viola yedoensis and Polygonum cuspidatum, add 8 times their total weight of 65% ethanol solution for percolation extraction at a rate of 2 mL per minute, collect the percolate, recover the ethanol until there is no alcohol odor, concentrate under reduced pressure to obtain ethanol extract. (c) Take the remaining raw materials except for bitter bean, violet and Japanese knotweed, add water and decoct three times, each time adding water to 9 times the total weight of the medicinal materials, decoct for 1.5 hours each time, combine the extracts, filter, concentrate under reduced pressure to obtain water extract. (d) Combine the alcohol extract from step (b) with the water extract from step (c), mix well, and concentrate to a total extract with a relative density of 1.22 at 60°C. (e) Heat petrolatum, cetyl alcohol, and glycerin to 80°C to melt, add sodium dodecyl sulfate and ethylparaben, stir to dissolve, and use as the oil phase; (f) Heat the total extract from step (d) to 80°C as the aqueous phase; (g) Add the aqueous phase slowly to the oil phase while stirring, emulsify (4000 rpm) until uniform, and cool to 45°C; (h) Add the bitter bean dry distilled oil from step (a), stir well, and pass it through a colloid mill (the average particle size after grinding is 20μm) to obtain the product.

[0044] Comparative Example 1

[0045] The other methods are the same as in Example 5, except that the addition of *Pseudostellaria heterophylla*, *Toona sinensis* bark, and *Pseudolarix amabilis* bark is omitted.

[0046] Comparative Example 2

[0047] The other methods are the same as in Example 5, except that the prickly ash bark, ailanthus bark, and sesame bark are replaced with equal amounts of coptis bark, phellodendron bark, and dictamnus bark.

[0048] Comparative Example 3

[0049] The other methods are the same as in Example 5, except that the bamboo leaf pepper and pine needles are replaced with equal amounts of Sichuan pepper and styrax.

[0050] Comparative Example 4

[0051] The other methods are the same as in Example 5, except that bitter beans are not added.

[0052] Comparative Example 5

[0053] The other methods are the same as in Example 5, except that the preparation method is different. The method for preparing the traditional Chinese medicine composition includes the following steps: Its preparation method includes the following steps: (a) Take all raw materials, add water and decoct three times, each time adding water to 9 times the total weight of the medicinal materials, decoct for 1.5 hours each time, combine the extracts, filter, concentrate under reduced pressure to obtain water extract; (b) Melt petrolatum, cetyl alcohol, and glycerin at 80°C, add sodium dodecyl sulfate and ethylparaben, stir to dissolve, and use as the oil phase; (c) Heat the total extract from step (a) to 80°C as the aqueous phase; (d) Add the aqueous phase slowly to the oil phase while stirring, and emulsify until homogeneous to obtain the final product.

[0054] Experimental Example 1

[0055] Healthy rabbits were selected and their backs were shaved to create two groups: intact skin and damaged skin. The samples from Examples 1 to 5 were applied to the rabbits once a day for 7 consecutive days. The rabbits were washed off 4 hours after each application. Erythema and edema at the application site were observed at 24, 48, and 72 hours after the last application. The scores were recorded according to the skin irritation scoring standard to evaluate the intensity of irritation.

[0056] Healthy guinea pigs were taken, and the hair on their backs was removed. The samples from Examples 1 to 5 were applied to them. Induction contact was performed on days 1, 4, and 7, and challenge contact was performed on day 21. Each contact was closed and fixed for 6 hours. Skin reactions were observed at 24, 48, and 72 hours after challenge. The sensitization rate was calculated according to the sensitization reaction scoring standard, and the sensitization was determined. The results are shown in Table 1.

[0057] Table 1 Toxicological Experiments

[0058] The toxicological results in Table 1 show that the traditional Chinese medicine compositions prepared in Examples 1 to 5 of this invention did not cause erythema or edema after being administered to intact and damaged skin of rabbits for 7 consecutive days, and the skin irritation score was non-irritating. At the same time, in the guinea pig skin allergy test, no skin allergic reaction was observed after induction and challenge contact, and the sensitization rate was zero. This indicates that the ointment composition has good safety and tolerability for topical skin application, and no obvious irritation or sensitization was observed.

[0059] Experiment Example 2

[0060] Take 1.0 g of the test drug (samples from Example 5, Comparative Examples 1-5, and products from the prior art group prepared according to method CN 1965959A) and aseptically weigh them into sterile Petri dishes for later use. The test bacterial strains selected are Staphylococcus aureus (ATCC 6538), Streptococcus pyogenes (ATCC 19615), Escherichia coli (ATCC 8099), and Pseudomonas aeruginosa (ATCC 15442). After inoculating each strain onto a suitable culture medium for activation and culture, prepare a culture with a bacterial count of approximately 1 × 10⁻⁶ using sterile physiological saline. 8 ~5×10 8 Prepare a bacterial suspension at CFU / mL. Take a sterile carrier (a circular filter paper disc with a diameter of 10 mm), add 50 μL of bacterial suspension to each disc, and dry at room temperature for later use.

[0061] The above-mentioned bacterial carriers were completely immersed in each test ointment and allowed to act for 5 min, 10 min and 60 min respectively. After the set time, the carriers were removed and immediately placed in a test tube containing 5 mL of neutralizing agent (PBS solution containing 3% Tween-80 and 0.3% lecithin). The tubes were shaken thoroughly to elute the bacteria. The eluent was used for viable cell counting culture. Two plates were inoculated for each dilution. After incubation at 37°C for 48 h, the colony count was counted. Each batch of tests was repeated 3 times.

[0062] The bactericidal rate at each time point was calculated using the following formula: Bactericidal rate (%) = (Average colony count in the positive control group - Average colony count in the experimental group) / Average colony count in the positive control group × 100%. The in vitro antibacterial effect of each ointment composition was evaluated based on the bactericidal rate. The results are shown in Tables 2 to 5.

[0063] Table 2. Sterilization rate (%) of Staphylococcus aureus at different treatment times

[0064] Table 3. Strenuous pyogenicity (%) at different treatment times

[0065] Table 4. Sterilization rate of Escherichia coli at different treatment times (%)

[0066] Table 5. Killing rate (%) of Pseudomonas aeruginosa at different treatment times

[0067] According to the antibacterial function test results in Tables 2 to 5, the traditional Chinese medicine composition of Example 5 of this invention exhibits broad-spectrum and rapid bactericidal activity against four common skin pathogens: Staphylococcus aureus, Streptococcus pyogenes, Escherichia coli, and Pseudomonas aeruginosa. Its bactericidal effect is evident within a short contact time and continues to increase with prolonged action time, ultimately reaching an extremely high bactericidal level. Compared with existing technologies, Example 5 shows a significant bactericidal advantage at all points of action, indicating that the formulation design and extraction process of this invention represent a significant advancement in antibacterial efficacy, enabling more effective inhibition and killing of various pathogens associated with skin infections.

[0068] Further comparison of the comparative examples reveals that Comparative Example 5, which uses a single water decoction extraction of all medicinal materials, exhibits the weakest bactericidal ability among all groups. This indicates that the stepwise extraction method of this invention—dry distillation of Sophora flavescens, alcohol extraction of Viola yedoensis and Polygonum cuspidatum, and water extraction of the remaining medicinal materials—is more conducive to preserving and enriching active antibacterial components. Meanwhile, Comparative Example 1, which omits Coptis chinensis, Toona sinensis bark, and Pseudolarix amabilis bark, and Comparative Example 4, which lacks Sophora flavescens, shows significantly inferior bactericidal effects compared to Example 5, demonstrating the indispensability of these medicinal materials in the overall formula for antibacterial performance. While Comparative Examples 2 and 3, which replace some medicinal materials with similar or commonly used substitutes, show better bactericidal activity than the other comparative examples, they are still inferior to Example 5. This further confirms that the specific combination and ratio of medicinal ingredients selected in this invention have a synergistic effect, and the preparation method can maximize the efficacy of the medicine.

[0069] Experimental Example 3

[0070] 1. Kunming mice (18-22g, half male and half female) were randomly divided into several groups of 15 mice each, designated as Example 5 group, Comparative Examples 1-5 group, and the prior art group. Each group of mice had 0.59g of the corresponding drug applied to its right ear twice daily for 3 consecutive days. One hour after the last administration on the 4th day, residual drug was washed away with distilled water and the ear was cleaned. Subsequently, 0.05mL of xylene was evenly applied to both sides of the right ear of each group to induce inflammation. The left ear was left untreated as a self-control. The animals were euthanized by cervical dislocation 30 minutes after inflammation induction.

[0071] Using an 8mm diameter punch, two ear pieces were punched from the same location along the ear margin. These pieces were then precisely weighed on an electronic balance, and the weight difference between the left and right ear pieces was used as the degree of auricular swelling (mg). The average swelling degree and standard deviation for each group were calculated. The swelling inhibition rate was calculated using the following formula: Swelling inhibition rate (%) = (Average swelling degree of blank control group - Average swelling degree of treated group) / Average swelling degree of blank control group × 100%. This was used to evaluate the inhibitory effect of each preparation on acute inflammation. By comparing the swelling degree and inhibition rate of each group, the anti-inflammatory effect of the herbal composition of this invention on xylene-induced acute auricular inflammation was evaluated. The results are shown in Table 6.

[0072] Table 6. Effects of the formulation on ear swelling in mice.

[0073] Table 6 shows that the auricular swelling in Example 5 was the smallest among all test groups, significantly better than that of the comparative examples and the prior art group, indicating that the complete formulation and the preferred preparation process of the present invention have the best synergistic anti-inflammatory effect. Comparative example 5 had the worst effect because it abandoned the key extraction process. The anti-inflammatory effects of comparative examples 1 to 4 were weakened to varying degrees due to the absence or replacement of specific medicinal ingredients or the lack of bitter bean, which confirms the indispensability of each medicinal ingredient in the formulation and the step-by-step extraction process to the efficacy.

[0074] 2. SD rats (150-180g, half male and half female) were randomly divided into several groups of 10 rats each, designated as Example 5 group, Comparative Examples 1-5, and the existing technology group. One day before the experiment, the normal volume (mL) of the right hind paw of each group was measured using capillary amplification as the baseline value before inflammation. On the day of the experiment, 0.2g / rat of the corresponding drug was applied to the right hind paw of each group. One hour after drug administration, 0.05mL / rat of 100% fresh egg white was injected subcutaneously into the right hind paw to induce acute inflammation. Immediately after injection, the same dose of drug was applied again. The matrix control group received an equal amount of matrix.

[0075] The volume of the right hind paw of rats in each group was measured again at 1 h, 2 h, and 4 h after inflammation induction. The difference between the volume at each time point after inflammation induction and the baseline volume before inflammation induction was used as the paw swelling degree (mL). The mean swelling degree and standard deviation of each group were calculated, and the differences between groups were compared to evaluate the inhibitory effect of each preparation on acute nonspecific inflammation induced by egg white. The results are shown in Table 7.

[0076] Table 7. Volume difference of the right hind foot (ml)

[0077] Table 7 shows that Example 5 significantly inhibited egg white-induced rat paw edema at different time points, demonstrating superior effects compared to the comparative examples and the prior art group. This indicates that the ointment composition of the present invention exhibits the best anti-inflammatory effect under the complete formulation and optimized process. Among the comparative examples, Comparative Example 3 showed relatively better results, but still inferior to Example 5, suggesting that the combination of *Zanthoxylum bungeanum* and *Pinus massoniana* has certain specific advantages. Comparative Examples 1 and 5 showed poorer results, indicating that the absence of the aforementioned medicinal materials and the single water extraction process significantly weakened the overall anti-inflammatory activity. Comparative Examples 2 and 4 also showed varying degrees of decreased anti-inflammatory activity, further confirming the rationality of the principal, assistant, adjuvant, and guide formulation of the present invention and the necessity of introducing pyrolysis oil. Overall, Example 5 maintained a low level of swelling at all observation points after inflammation induction, demonstrating rapid onset and sustained relief. In contrast, the swelling inhibition ability of the control group and the comparative examples weakened with prolonged action time, reflecting the significant advantage of the composition of the present invention in terms of anti-inflammatory duration.

[0078] Experiment Example 4

[0079] I. Case Screening and Diagnostic Criteria

[0080] This study selected 60 patients with chronic eczema who met both Western and Traditional Chinese Medicine (TCM) diagnostic criteria (30 males and 30 females, mean age 33.3 years, disease duration 1–19 months). Western medicine diagnosis was based on "Clinical Dermatology," characterized by thickened and infiltrated skin lesions, brownish-red or grayish-brown pigmentation, rough, scaly surface, lichenification, and localized severe itching. TCM diagnosis was based on the damp-heat type criteria in "Guiding Principles for Clinical Research of New Traditional Chinese Medicines," requiring the primary symptom of severe itching, significant exudation, and burning erythema, along with secondary symptoms such as irritability, thirst, dark urine, dry stools, red tongue with a yellow, greasy coating, and a slippery pulse. Patients were only eligible for inclusion if they met both the primary symptom and at least two secondary symptoms.

[0081] II. Subject Inclusion, Exclusion, and Ethical Guidelines

[0082] Inclusion criteria were limited to patients aged 18 to 65 years, without serious organic diseases or mental disorders, who could cooperate with observation, and who signed informed consent forms. Exclusion criteria were strictly enforced, excluding pregnant and lactating women, patients with serious underlying cardiovascular, cerebrovascular, liver, or kidney diseases, patients who had used glucocorticoids or retinoids within the past two weeks, and patients allergic to any component of the investigational drug or with other complications that could interfere with efficacy assessment, to ensure the homogeneity and safety of the study population.

[0083] III. Randomization and Dosing Regimen

[0084] Sixty eligible patients were randomly divided into two groups (half male and half female) using a random number table. The treatment group (30 cases) received the ointment prepared according to Example 5 of this invention, applied evenly to the affected skin three times a day for seven consecutive days as one course of treatment, for a total of two courses. The control group (30 cases) received commercially available mometasone furoate cream, applied once a day, also for seven days as one course of treatment, for a total of two courses. During the treatment period, all patients were strictly advised to avoid spicy foods, beef, mutton, and other foods that may aggravate the condition, and to refrain from washing the affected area with hot water and soap, and to avoid scratching, in order to eliminate external interference factors.

[0085] IV. Efficacy Observation Indicators and Safety Monitoring

[0086] The Hani-fin eczema severity scoring system was used. Six physical signs—erythema, papules, infiltration and thickening, scratch marks, lichenification, and crusting—were scored on a four-level scale (0 for asymptomatic and 3 for severe) before and after treatment. The degree of itching was also independently recorded (0-3 points for mild, moderate, and severe, corresponding to no itching). The onset and duration of itch relief were also calculated in hours. All scores were summed to obtain the total disease score. Regarding safety, all patients underwent complete blood count, urinalysis, liver function (ALT), and kidney function (Cr, BUN) tests before and after treatment. Researchers continuously recorded adverse reactions such as local irritation and burning sensations after drug administration to ensure continuous monitoring of drug tolerance and toxic side effects.

[0087] V. Criteria for Evaluating Therapeutic Effect and Statistical Processing

[0088] The efficacy index is calculated based on the difference in scores before and after treatment (efficacy index = (score before treatment - score after treatment) / score before treatment × 100%), and the clinical outcome is divided into four levels: cure (efficacy index ≥ 90%), significant effect (60% ≤ efficacy index < 90%), effective (20% ≤ efficacy index < 60%), and ineffective (efficacy index < 20%).

[0089] Table 8 Treatment Efficacy Survey Form

[0090] Table 9 Treatment Efficacy Survey Form

[0091] Table 8 shows that, in the clinical efficacy comparison of patients with chronic eczema, the ointment of Example 5 of this invention is superior to commercially available mometasone furoate cream in both overall effectiveness and cure rate, especially in controlling the course of the disease. The treatment group showed a significantly better trend in the number of cured and significantly effective cases than the control group, while the number of ineffective cases was smaller, suggesting that this traditional Chinese medicine composition has a comprehensive and stable therapeutic effect on damp-heat type eczema. This difference in efficacy may be due to the synergistic effect of multiple traditional Chinese medicines in this invention, which can clear heat and dry dampness, kill parasites and relieve itching, as well as promote blood circulation, remove blood stasis, and promote tissue regeneration, thereby intervening in the complex pathological process of eczema at multiple targets and overcoming the limitations of the limited action pathways of single chemical components.

[0092] Table 9 further shows that the ointment of this invention also exhibits significant advantages in improving patients' itching symptoms. Compared with the control group, the treatment group showed a more significant decrease in itching severity scores after administration, and also achieved earlier and longer-lasting antipruritic effects, indicating that this traditional Chinese medicine compound preparation can not only quickly relieve patients' subjective discomfort but also maintain a longer duration of efficacy. This combination of rapid and long-lasting effects is of great significance in improving the clinical dilemma of worsened itching and impaired sleep quality in eczema patients, and also reflects the excellent design of the transdermal penetration and local concentration maintenance of antipruritic active ingredients such as bitter bean oil, Cnidium monnieri, and Kochia scoparia in this invention.

[0093] Based on the combined evaluation indicators, the ointment of Example 5 of this invention showed a superior trend compared to the control group in terms of overall effective rate, cure rate, and duration of itching control, demonstrating the unique value of topical Chinese medicine preparations in the treatment of chronic eczema. Its therapeutic advantage may be attributed to the precise formulation of this invention targeting the pathogenesis of damp-heat accumulation, and the organic combination of dry distillation, alcohol extraction, and water extraction processes, which maximizes the preservation of both fat-soluble and water-soluble active ingredients. The above clinical observation results provide strong evidence for this Chinese medicine composition as an alternative or supplementary option to glucocorticoid drugs, especially suitable for eczema patients requiring long-term management, seeking low side effects, and avoiding hormone dependence.

[0094] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating itchy skin, characterized in that, The raw materials include the following parts by weight: Cnidium monnieri 60-80 parts, Coptis chinensis 40-60 parts, Toona sinensis bark 40-60 parts, Pseudolarix amabilis bark 50-80 parts, Brucea javanica 30-50 parts, Polygonum cuspidatum 80-100 parts, Viola yedoensis 80-100 parts, Kochia scoparia 60-90 parts, Polygonum aviculare 15-25 parts, Artemisia capillaris 20-30 parts, Atractylodes lancea 30-40 parts, Zanthoxylum bungeanum 20-30 parts, Pinus massoniana 15-25 parts, Commiphora myrrha 5-10 parts, and Sophora flavescens 30-50 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It also includes the following excipients in parts by weight: 230-270 parts petrolatum, 100-120 parts cetyl alcohol, 8-18 parts sodium lauryl sulfate, 150-180 parts glycerin, and 1-3 parts ethylparaben.

3. A method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: (a) Take bitter beans, place them in a dry distillation kettle, heat them, and evacuate the air to make the vacuum pressure not lower than 0.02 MPa. When the furnace temperature rises to 180-200℃, carry out heat preservation dry distillation and collect the distilled oil to obtain bitter bean dry distilled oil. (b) Take Viola yedoensis and Polygonum cuspidatum, add ethanol solution for percolation extraction, collect the percolate, recover the ethanol until there is no alcohol odor, concentrate under reduced pressure to obtain alcohol extract; (c) Take the remaining raw materials except for bitter bean seed, violet and Japanese knotweed, decoct with water 2 to 3 times, combine the extracts, filter, concentrate under reduced pressure to obtain water extract. (d) Combine the alcohol extract from step (b) with the water extract from step (c), mix well, and concentrate to obtain the total extract; (e) Heat petrolatum, cetyl alcohol, and glycerin to 75-85°C to melt, add sodium dodecyl sulfate and ethylparaben, stir to dissolve, and use as the oil phase; (f) Heat the total extract from step (d) to 75–85°C as the aqueous phase; (g) Add the aqueous phase slowly to the oil phase while stirring, emulsify evenly, and cool to 40-50°C; (h) Add the bitter bean dry distilled oil from step (a) and stir well to obtain the final product.

4. The method according to claim 3, characterized in that, In step (b), the amount of ethanol solution used during percolation extraction is 6 to 10 times the total weight of Viola yedoensis and Polygonum cuspidatum, and the percolation rate is 1 to 3 mL per minute.

5. The method according to claim 4, characterized in that, The volume concentration of the ethanol solution in step (b) is 60% to 70%.

6. The method according to claim 3, characterized in that, In step (c), the amount of water added during each decoction and extraction is 6 to 12 times the total weight of the medicinal materials, and the decoction time is 1 to 2 hours each time; the relative density of the total extract in step (d) at 60°C is 1.20 to 1.

25.

7. The method according to claim 3, characterized in that, The emulsification speed in step (g) is 2000~10000 rpm; after stirring evenly in step (h), the material is further ground by a colloid mill, and the particle size of the ground material is 2~40μm.

8. The use of the traditional Chinese medicine composition according to claim 1 or 2 or the traditional Chinese medicine composition prepared by any one of the preparation methods according to claims 3 to 7 in the preparation of a medicament for treating eczema, dermatitis, tinea or pruritus.

9. The application according to claim 8, characterized in that, The types of drugs are creams, gels, lotions, liniments, tinctures, sprays, or plasters.

10. An ointment preparation for treating eczema, dermatitis, tinea, or pruritus, characterized in that, It is made from the traditional Chinese medicine composition according to claim 1 or 2 or the traditional Chinese medicine composition prepared by any one of the preparation methods according to claims 3 to 7.

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