A traditional Chinese medicine composition for treating atopic dermatitis, and a preparation method and application thereof

Abstract

The application provides a traditional Chinese medicine composition for treating atopic dermatitis and a preparation method and application thereof, and belongs to the technical field of biological medicine. The traditional Chinese medicine composition comprises 15-25 parts of schizonepeta tenuifolia, 25-35 parts of saposhnikovia divaricata, 15-25 parts of brassica juncea, 15-25 parts of notopterygium incisum, 15-25 parts of stemona, 25-35 parts of dictamnus dasycarpus, 15-25 parts of sophora flavescens, 15-25 parts of plumeria alba, 5-15 parts of kudzuvine leaf and 5-15 parts of licorice. The traditional Chinese medicine composition has the effects of opening the skin, promoting the eruption, clearing heat and removing dampness and relieving itching. The clinical research results show that the traditional Chinese medicine composition can effectively relieve itching and reduce skin symptoms, achieves the effect of efficiently treating atopic dermatitis, and even the treatment effect is better than that of a positive drug. In addition, the preparation method is simple and easy to operate, is suitable for industrial production, and the traditional Chinese medicine composition prepared by the preparation method has high patient acceptance, good transdermal property and high safety.

Description

Technical Field

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

[0002] Atopic dermatitis (AD) is a chronic, relapsing inflammatory disease with diverse clinical manifestations. Its most basic characteristics are dry skin, chronic eczematous lesions, and significant itching, severely impacting patients' quality of life. AD mostly begins in infancy, with a high percentage of cases occurring before the age of one, and in some patients, the condition can persist into adulthood.

[0003] For patients with mild to moderate atopic dermatitis (AD), current treatment primarily involves traditional topical medications such as topical corticosteroids (TCS) and topical calcineurin inhibitors (TCI). For severe cases, systemic use of immunosuppressants, corticosteroids, and biologics is required. However, these treatments still have limitations and adverse reactions, especially in children with atopic dermatitis. For example, long-term, large-area use of TCS may lead to skin and systemic adverse reactions; children are more likely to experience transdermal absorption of topical medications, increasing the risk of adverse reactions. TCIs may cause local burning and irritation. The safety and efficacy of some immunosuppressants and biologics in children are still unclear. For instance, abuxitinib is only approved for moderate to severe AD in adults, and its safety and efficacy in children and adolescents under 18 years of age are unclear. 2% criborone ointment is approved for mild to moderate AD in children over 2 years of age and adults. Therefore, providing a traditional Chinese medicine composition for the effective treatment of atopic dermatitis, especially in children, is a pressing issue in this field. Summary of the Invention

[0004] Therefore, the purpose of this invention is to provide a traditional Chinese medicine composition for treating atopic dermatitis, its preparation method and application, which can effectively treat atopic dermatitis and has high safety.

[0005] To achieve the above-mentioned objectives, the present invention provides the following technical solution: This invention provides a traditional Chinese medicine composition for treating atopic dermatitis, comprising the following raw materials in parts by weight: 15-25 parts of Schizonepeta tenuifolia spike, 25-35 parts of Saposhnikovia divaricata, 15-25 parts of Mustard seed, 15-25 parts of Notopterygium incisum, 15-25 parts of Stemona japonica, 25-35 parts of Dictamnus dasycarpus root bark, 15-25 parts of Sophora flavescens, 15-25 parts of Plumeria rubra, 5-15 parts of Hibiscus mutabilis leaf, and 5-15 parts of Glycyrrhiza uralensis.

[0006] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 17-23 parts of Schizonepeta tenuifolia spike, 26-32 parts of Saposhnikovia divaricata, 17-24 parts of Mustard seed, 16-24 parts of Notopterygium incisum, 17-22 parts of Stemona japonica, 27-34 parts of Dictamnus dasycarpus root bark, 17-24 parts of Sophora flavescens root, 16-24 parts of Plumeria rubra flower, 7-13 parts of Hibiscus mutabilis leaf, and 7-13 parts of Glycyrrhiza uralensis.

[0007] This invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: Mix the aforementioned Stemona japonica, Dictamnus dasycarpus, Sophora flavescens, Sinapis alba, and Glycyrrhiza uralensis, then mix with water, soak, boil, and decoct for the first time. Then add the aforementioned Schizonepeta tenuifolia, Saposhnikovia divaricata, and Notopterygium incisum, and continue to decoct for the second time. Finally, add the aforementioned Frangipani and Hibiscus mutabilis leaves, and continue to decoct for the third time. Filter, collect the filtrate, and obtain the aforementioned traditional Chinese medicine composition.

[0008] Preferably, the soaking method is to soak at 20~25℃ for 25~35 minutes.

[0009] Preferably, the mixture of catnip spikes, saposhnikovia root, mustard seed, notopterygium root, stemona root, dictamnus root bark, sophora root, frangipani flower, hibiscus leaf, and licorice is a raw material mixture; the mass-to-volume ratio of the raw material mixture to water is 1g:20~30mL.

[0010] Preferably, the first decoction is simmered over low heat for 15-25 minutes, the second decoction is simmered over low heat for 8-12 minutes, and the third decoction is simmered over low heat for 4-7 minutes.

[0011] This invention provides a traditional Chinese medicine composition prepared by the above-described preparation method.

[0012] This invention provides an application of the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method in the preparation of drugs for atopic dermatitis.

[0013] Preferably, the atopic dermatitis is childhood atopic dermatitis.

[0014] Preferably, the drug further includes pharmaceutically acceptable excipients.

[0015] Compared with the prior art, the present invention has the following beneficial effects: This invention provides a traditional Chinese medicine composition for treating atopic dermatitis, its preparation method, and its application. The composition uses *Schizonepeta tenuifolia* and *Saposhnikovia divaricata* as the principal herbs, which have the effect of dispelling cold and opening the exterior; *Notopterygium incisum* and *Sinapis alba* as the assistant herbs, which have the effect of unblocking the channels, dispelling cold, relieving exterior symptoms, dispelling wind, and eliminating dampness; *Stemona japonica*, *Dictamnus dasycarpus*, *Sophora flavescens*, *Frangipani florida*, and *Hibiscus mutabilis* as adjuvant herbs, which have the effects of relieving itching, clearing heat and dampness, and cooling the blood; and licorice root as the guiding herb to harmonize the properties of the herbs. The combined effects of these herbs are to open the exterior, promote rash eruption, clear heat and dampness, and relieve itching. Clinical studies have shown that the composition effectively relieves itching and significantly reduces skin symptoms, achieving a highly effective treatment for atopic dermatitis, even outperforming positive control drugs. Furthermore, the preparation method of this invention is simple and easy to operate, suitable for industrial production, and the composition obtained by this method does not require oral administration, has high acceptability, good transdermal properties, and no obvious local irritation or allergic reactions such as rash, redness, swelling, stinging, or local burning, demonstrating high safety. Attached Figure Description

[0016] Figure 1 The improvement of right foot symptoms in a patient with typical case 1 after 4 weeks of treatment with the traditional Chinese medicine wash solution in Example 1.

[0017] Figure 2 The improvement of right foot symptoms in a patient in typical case 2 after two weeks of treatment with the traditional Chinese medicine wash solution from Example 1. Detailed Implementation

[0018] This invention provides a traditional Chinese medicine composition for treating atopic dermatitis, comprising the following raw materials in parts by weight: 15-25 parts of Schizonepeta tenuifolia spike, 25-35 parts of Saposhnikovia divaricata, 15-25 parts of Mustard seed, 15-25 parts of Notopterygium incisum, 15-25 parts of Stemona japonica, 25-35 parts of Dictamnus dasycarpus root bark, 15-25 parts of Sophora flavescens, 15-25 parts of Plumeria rubra, 5-15 parts of Hibiscus mutabilis leaf, and 5-15 parts of Glycyrrhiza uralensis.

[0019] In this invention, as a preferred embodiment, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15-25 parts of Schizonepeta tenuifolia spike, 25-35 parts of Saposhnikovia divaricata, 15-25 parts of Mustard seed, 15-25 parts of Notopterygium incisum, 15-25 parts of Stemona japonica, 25-35 parts of Dictamnus dasycarpus root bark, 15-25 parts of Sophora flavescens, 15-25 parts of Plumeria rubra, 5-15 parts of Hibiscus mutabilis leaf, and 5-15 parts of Glycyrrhiza uralensis.

[0020] In a preferred embodiment of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 17-23 parts of Schizonepeta tenuifolia spike, 26-32 parts of Saposhnikovia divaricata, 17-24 parts of Mustard seed, 16-24 parts of Notopterygium incisum, 17-22 parts of Stemona japonica, 27-34 parts of Dictamnus dasycarpus root bark, 17-24 parts of Sophora flavescens, 16-24 parts of Frangipani flower, 7-13 parts of Hibiscus mutabilis leaf, and 7-13 parts of Glycyrrhiza uralensis. More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 20 parts of Schizonepeta tenuifolia spike, 30 parts of Saposhnikovia divaricata, 20 parts of Mustard seed, 20 parts of Notopterygium incisum, 20 parts of Stemona japonica, 30 parts of Dictamnus dasycarpus root bark, 20 parts of Sophora flavescens, 20 parts of Frangipani flower, 10 parts of Hibiscus mutabilis leaf, and 10 parts of Glycyrrhiza uralensis.

[0021] In this invention, *Nepeta cataria* is a plant of the Lamiaceae family. Schizonepeta tenuisfolia Dried flower spikes of *Britschia mirabilis*. It has a pungent taste and slightly warm properties. It enters the lung and liver meridians. It has the effects of relieving exterior syndromes, dispelling wind, promoting rash eruption, and eliminating sores. *Britschia mirabilis* flower spikes contain numerous chemical components, including volatile oils, flavonoids, terpenes, and other compounds, possessing anti-inflammatory, anti-ulcer, and antibacterial pharmacological effects. This invention does not have specific limitations on the source of *Britschia mirabilis* flower spikes; commercially available products in this field are acceptable.

[0022] In this invention, *Saposhnikovia divaricata* is a plant belonging to the Apiaceae family. Saposhnikovia divaricata The dried root of *Saposhnikovia divaricata* (Turcz.) Schishk. It has a pungent and sweet taste, and is slightly warm in nature. It enters the bladder, liver, and spleen meridians. It has the effects of dispelling wind and releasing the exterior, eliminating dampness and relieving pain, and stopping spasms. *Saposhnikovia divaricata* contains various chemical components such as chromogens, volatile oils, coumarins, and polysaccharides, and has pharmacological effects such as antipyretic, analgesic, anti-inflammatory, antitumor, anticonvulsant, anti-allergic, and antiviral properties. This invention does not have a specific limitation on the source of *Saposhnikovia divaricata*; commercially available products in this field are acceptable.

[0023] In this invention, the mustard seed is white mustard, a plant belonging to the Brassicaceae family. White mustard L. or mustard Brassica juncea The dried, mature seeds of *L.) Czern. et Coss., also known as mustard seeds, green mustard seeds, or yellow mustard seeds. They have a pungent taste and warm properties. They enter the lung meridian. They have the effects of warming the lungs, resolving phlegm, promoting qi circulation, dispersing stagnation, unblocking meridians, and relieving pain. The main components of mustard seeds are glucosinolates and isothiocyanates produced by hydrolysis under the action of myrosinase, which have pharmacological effects such as anti-inflammatory, analgesic, antibacterial, expectorant, and immunomodulatory effects. This invention does not have a specific limitation on the source of mustard seeds; commercially available products in this field are acceptable.

[0024] In this invention, *Notopterygium incisum* refers to the plant *Notopterygium incisum*, belonging to Notopterygium incisum Ting ex HTChang or Broadleaf Notopterygium Notopterygium franchetiiThe dried rhizome and root of *H. de Boiss.*. It has a pungent and bitter taste, and is warm in nature. It enters the bladder and kidney meridians. It has the effects of relieving exterior syndromes, dispelling cold, eliminating wind and dampness, and relieving pain. The main chemical components of *Notopterygium incisum* include volatile oils, coumarins, and sugars, which have pharmacological effects such as anti-inflammatory, analgesic, antipyretic, antibacterial, and antiarrhythmic properties. This invention does not have a specific limitation on the source of *Notopterygium incisum*; commercially available products in this field are acceptable.

[0025] In this invention, *Stemona japonica* refers to the plant *Stemona chinensis*, belonging to the family Stemonaceae. Stemona sessilefolia (Miq.) Miq., overflowing with flowers Japanese stemona (Bl.)Miq. or Pseudostellaria heterophylla Tuberous stemona The dried tuberous root of *Stemona japonica*. It has a sweet and bitter taste, and is slightly warm in nature. It enters the lung meridian. It has the effects of moistening the lungs, lowering qi, relieving cough, and killing insects and lice. The main active ingredient of *Stemona japonica* is alkaloids, which have pharmacological effects such as antitussive, expectorant, insecticidal, and antibacterial properties. This invention does not have a specific limitation on the source of *Stemona japonica*; commercially available products in this field are acceptable.

[0026] In this invention, *Dictamnus dasycarpus* is the plant *Dictamnus dasycarpus* of the Rutaceae family. Dictamnus dasycarpus Dried root bark of *Turcz.*. Bitter in taste and cold in nature. It enters the spleen, stomach, and bladder meridians. It has the effects of clearing heat and drying dampness, dispelling wind and detoxifying. *Dictamnus dasycarpus* root bark mainly contains alkaloids, sesquiterpenes, limonene, fatty acids, volatile oils, flavonoids, and steroids, and has pharmacological effects such as antibacterial, anti-inflammatory, insecticidal, anti-allergic, anticancer, cardiovascular protection, and improvement of gastrointestinal motility. This invention does not have a specific limitation on the source of *Dictamnus dasycarpus* root bark; commercially available products in this field are acceptable.

[0027] In this invention, Sophora flavescens is the legume Sophora flavescens. Sophora flavense The dried root of *Ait.*. It has a bitter taste and is cold in nature. It enters the heart, liver, stomach, large intestine, and bladder meridians. It has the effects of clearing heat and drying dampness, killing parasites, and promoting diuresis. The main chemical components of *Sophora flavescens* are oxymatrine, matrine, and flavonoids, which have pharmacological effects such as antibacterial, anti-inflammatory, antiviral, hypoglycemic, hypolipidemic, and antioxidant properties. This invention does not have a specific limitation on the source of *Sophora flavescens*; commercially available products in this field are acceptable.

[0028] In this invention, the frangipani refers to the frangipani plant, which belongs to the Apocynaceae family. Red plumeria Dried flowers of *L.*. Sweet and slightly bitter in taste, cool in nature. Enters the lung and large intestine meridians. Has the effects of promoting diuresis, clearing heat, and relieving summer heat. The chemical components of *Plumeria rubra* mainly include flavonoids, volatile oils, iridoids, triterpenoids, phenolic compounds, and polysaccharides, etc., possessing various pharmacological effects such as anti-inflammatory, antioxidant, antibacterial, tumor cell growth inhibition, antipyretic analgesic, hypoglycemic, and liver protection. This invention does not specifically limit the source of *Plumeria rubra*; commercially available products in this field are acceptable.

[0029] In this invention, the hibiscus leaf refers to the hibiscus plant (Hibiscus mutabilis) of the Malvaceae family. Hibiscus mutabilis The dried leaves of *Hibiscus mutabilis*. It has a pungent taste and neutral properties. It enters the lung and liver meridians. It has the effects of cooling the blood, detoxifying, reducing swelling, and relieving pain. The main components of *Hibiscus mutabilis* leaves are flavonoids, which have anti-inflammatory, analgesic, and antibacterial pharmacological effects. This invention does not have a specific limitation on the source of *Hibiscus mutabilis* leaves; commercially available products in this field are acceptable.

[0030] In this invention, licorice refers to the legume *Glycyrrhiza uralensis*. Glycyrrhiza uralensis Fisch., Licorice inflata Inflated licorice Bat. or Licorice root Glycyrrhiza glabra The dried roots and rhizomes of *Licorice twig*. It has a sweet taste and neutral properties, and possesses the effects of tonifying the spleen and replenishing qi, clearing heat and detoxifying, resolving phlegm and relieving cough, alleviating spasms and pain, and harmonizing other medicines. The chemical components of licorice include flavonoids, saponins, alkaloids, amino acids, coumarins, and polysaccharides, exhibiting various pharmacological effects such as antioxidant, anti-inflammatory, immunomodulatory, anti-ulcer, antiviral, antidepressant, analgesic, hepatoprotective, and anti-atherosclerotic properties. This invention does not specifically limit the source of licorice; commercially available products in this field are acceptable.

[0031] In this invention, the traditional Chinese medicine composition uses Schizonepeta tenuifolia and Saposhnikovia divaricata as the principal herbs, which have the effect of dispelling cold and opening the exterior; Notopterygium incisum and Mustard seed as the assistant herbs, which have the effect of clearing the channels, dispelling cold, relieving exterior symptoms, dispelling wind and dampness; Stemona japonica, Dictamnus dasycarpus, Sophora flavescens, Plumeria rubra and Hibiscus mutabilis leaf as adjuvant herbs, which have the effect of relieving itching, clearing heat and promoting diuresis and cooling blood; Glycyrrhiza uralensis is the guiding herb to harmonize the properties of the herbs; the combined use of these herbs achieves the effects of opening the exterior and promoting rash eruption, clearing heat and removing dampness, and relieving itching, and can effectively treat atopic dermatitis.

[0032] This invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps: Mix the aforementioned Stemona japonica, Dictamnus dasycarpus, Sophora flavescens, Sinapis alba, and Glycyrrhiza uralensis, then mix with water, soak, boil, and decoct for the first time. Then add the aforementioned Schizonepeta tenuifolia, Saposhnikovia divaricata, and Notopterygium incisum, and continue to decoct for the second time. Finally, add the aforementioned Frangipani and Hibiscus mutabilis leaves, and continue to decoct for the third time. Filter, collect the filtrate, and obtain the aforementioned traditional Chinese medicine composition.

[0033] In this invention, the Stemona japonica, Dictamnus dasycarpus root bark, Sophora flavescens root, mustard seed, and licorice are mixed. This invention does not impose any particular limitation on the mixing method; any method known in the art, such as stirring, may be used.

[0034] In this invention, after mixing, the mixture is then mixed with water, soaked, boiled, and decocted for the first time. Then, the *Schizonepeta tenuifolia*, *Saposhnikovia divaricata*, and *Notopterygium incisum* are added, and a second decoction is performed. Finally, the *Frangipani* and *Hibiscus mutabilis* leaves are added, and a third decoction is performed. The mixture is filtered, and the filtrate is collected to obtain the traditional Chinese medicine composition. The *Schizonepeta tenuifolia*, *Saposhnikovia divaricata*, mustard seed, *Notopterygium incisum*, *Stemona japonica*, *Dictamnus dasycarpus*, *Sophora flavescens*, *Frangipani*, *Hibiscus mutabilis* leaves, and licorice are mixed as a raw material mixture. That is, the *Schizonepeta tenuifolia*, *Saposhnikovia divaricata*, mustard seed, *Notopterygium incisum*, *Stemona japonica*, *Dictamnus dasycarpus*, *Sophora flavescens*, *Frangipani*, *Hibiscus mutabilis* leaves, and licorice are mixed according to the above-mentioned weight proportions to obtain the raw material mixture. The mass-to-volume ratio of the raw material mixture to water is preferably 1g:20-30mL, more preferably 1g:22-28mL, and even more preferably 1g:25mL. The soaking method is preferably soaking at 20-25℃ for 25-35 minutes. More preferably, soaking at 20-25℃ for 26-34 minutes, and even more preferably soaking at 20-25℃ for 30 minutes. The boiling method is high heat. The first decoction is preferably simmered over low heat for 15-25 minutes, more preferably 17-23 minutes, and even more preferably 20 minutes. The second decoction is preferably simmered over low heat for 8-12 minutes, more preferably 9-11 minutes, and even more preferably 10 minutes. The third decoction is preferably simmered over low heat for 4-7 minutes, more preferably 5-6 minutes, and even more preferably 5 minutes. This invention utilizes soaking, boiling, and then decoction to extract the active ingredients of the traditional Chinese medicine composition, which can effectively treat atopic dermatitis, especially childhood atopic dermatitis, with better efficacy than positive control drugs. This invention does not specifically limit the filtration method; any filtration method known in the art, such as gauze filtration, membrane filtration, or centrifugal filtration, can be used.

[0035] This invention provides a traditional Chinese medicine composition prepared by the above-described preparation method.

[0036] This invention provides an application of the above-mentioned traditional Chinese medicine composition or the traditional Chinese medicine composition prepared by the above-mentioned preparation method in the preparation of drugs for atopic dermatitis.

[0037] In this invention, the atopic dermatitis is preferably childhood atopic dermatitis, and the child's age is 6 months to 12 years. In this invention, the Investigator Global Assessment (IGA) is used for scoring, where an IGA of 0 indicates clearance of atopic dermatitis, an IGA of 1 indicates substantial clearance of atopic dermatitis, an IGA of 2 indicates mild atopic dermatitis, an IGA of 3 indicates moderate atopic dermatitis, and an IGA of 4 indicates severe atopic dermatitis. According to the IGA score, the atopic dermatitis of this invention is preferably mild and / or moderate atopic dermatitis. The drug also includes pharmaceutically acceptable excipients. The excipients include one or more of solvents, preservatives, solubilizers, surfactants, or fragrances. In this invention, the above-mentioned traditional Chinese medicine composition, also known as a traditional Chinese medicine wash, is the sole active ingredient. In this invention, the traditional Chinese medicine composition accounts for 4% to 80% of the drug's mass percentage. This invention utilizes the above-mentioned traditional Chinese medicine composition to apply a wet compress to the affected area. The wet compress is applied for 10 minutes each time, twice a day.

[0038] In this invention, unless otherwise specified, all raw material components are commercially available products well known to those skilled in the art.

[0039] 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.

[0040] In the following embodiments, the room temperature is 20~25°C.

[0041] Example 1 A traditional Chinese medicine composition for treating atopic dermatitis, made from the following raw materials by weight: 20g of Schizonepeta tenuifolia spike, 30g of Saposhnikovia divaricata, 20g of Mustard seed, 20g of Notopterygium incisum, 20g of Stemona japonica, 30g of Dictamnus dasycarpus root bark, 20g of Sophora flavescens root, 20g of Plumeria rubra flower, 10g of Hibiscus mutabilis leaf, and 10g of Glycyrrhiza uralensis.

[0042] A method for preparing a traditional Chinese medicine composition for treating atopic dermatitis, comprising the following steps: Add 5000mL of water to 20g of Stemona japonica, 30g of Dictamnus dasycarpus root bark, 20g of Sophora flavescens root, 20g of Mustard seed, and 10g of Glycyrrhiza uralensis root. Soak at room temperature for 30 minutes. Then bring to a boil over high heat and simmer over low heat for 20 minutes. Add 20g of Schizonepeta tenuifolia spike, 30g of Saposhnikovia divaricata root, and 20g of Notopterygium incisum root. Continue to simmer over low heat for 10 minutes. Add 20g of Frangipani flower and 10g of Hibiscus mutabilis leaf. Continue to simmer over low heat for 5 minutes. Filter and collect the filtrate to obtain the Chinese herbal composition (named Chinese herbal wash).

[0043] Example 2 A traditional Chinese medicine composition for treating atopic dermatitis, made from the following raw materials by weight: 15g of Schizonepeta tenuifolia spike, 35g of Saposhnikovia divaricata, 15g of Mustard seed, 15g of Notopterygium incisum, 25g of Stemona japonica stem, 25g of Dictamnus dasycarpus root bark, 25g of Sophora flavescens root, 15g of Plumeria rubra flower, 15g of Hibiscus mutabilis leaf, and 5g of Glycyrrhiza uralensis.

[0044] A method for preparing a traditional Chinese medicine composition for treating atopic dermatitis, comprising the following steps: Add 3800mL of water to 25g of Stemona japonica, 25g of Dictamnus dasycarpus, 25g of Sophora flavescens, 15g of Sinapis alba, and 5g of Glycyrrhiza uralensis. Soak at room temperature for 25 minutes. Then bring to a boil over high heat and simmer over low heat for 15 minutes. Add 15g of Schizonepeta tenuifolia, 35g of Saposhnikovia divaricata, and 15g of Notopterygium incisum. Continue to simmer over low heat for 8 minutes. Add 15g of Frangipani florida and 15g of Hibiscus mutabilis leaves. Continue to simmer over low heat for 7 minutes. Filter and collect the filtrate to obtain the Chinese herbal composition (named Chinese herbal wash).

[0045] Example 3 A traditional Chinese medicine composition for treating atopic dermatitis, made from the following raw materials by weight: 25g of Schizonepeta tenuifolia spike, 25g of Saposhnikovia divaricata, 25g of Mustard seed, 25g of Notopterygium incisum, 15g of Stemona japonica, 35g of Dictamnus dasycarpus root bark, 15g of Sophora flavescens root, 25g of Plumeria rubra flower, 5g of Hibiscus mutabilis leaf, and 15g of Glycyrrhiza uralensis.

[0046] A method for preparing a traditional Chinese medicine composition for treating atopic dermatitis, comprising the following steps: Add 15g of Stemona japonica, 35g of Dictamnus dasycarpus root bark, 15g of Sophora flavescens root, 25g of Sinapis alba seed, and 15g of Glycyrrhiza uralensis root to 6300mL of water and soak at room temperature for 35 minutes. Then bring to a boil over high heat and simmer over low heat for 25 minutes. Add 25g of Schizonepeta tenuifolia spike, 25g of Saposhnikovia divaricata root, and 25g of Notopterygium incisum root and continue to simmer over low heat for 12 minutes. Add 25g of Frangipani florida flower and 5g of Hibiscus mutabilis leaf and continue to simmer over low heat for 4 minutes. Filter and collect the filtrate to obtain the Chinese herbal composition (named Chinese herbal wash).

[0047] Experimental Example 1 This experimental example is used to study the clinical efficacy of the traditional Chinese medicine composition prepared in Example 1 in the treatment of childhood atopic dermatitis. (1) Research subjects Case selection: This study primarily included 102 children aged 6 months to 12 years with mild to moderate atopic dermatitis who visited the Department of Dermatology at the Sixth People's Hospital of Dongguan City between May 2025 and May 2026. The diagnostic criteria, inclusion criteria, exclusion criteria, and dropout criteria for the study subjects are as follows: S1. Diagnostic Criteria 1. Western medicine diagnostic criteria: According to Yao's clinical diagnostic criteria for atopic dermatitis in Chinese children, a diagnosis of atopic dermatitis can be made when all of the following 3 items are simultaneously met: ① Pruritus; ② Typical morphology and site (flexural dermatitis) or atypical morphology and site accompanied by xeroderma; ③ Chronic or chronic recurrent course. The typical morphology and site (flexural dermatitis) includes involvement of the face and extremities in children.

[0048] The atypical morphology and site include: ① Typical eczematous rashes occurring at non-flexural sites (scalp dermatitis, eyelid eczema, nipple eczema, vulvar eczema, nummular eczema, fingertip eczema, nonspecific hand or foot dermatitis / atopic winter feet, nail or periungual eczema, and eczematous rashes on other parts of the body); ② Atypical eczematous rashes, including pityriasis simplex, cheilitis, infra-auricular and retro-auricular / subnasal fissures, prurigo, dyshidrotic eczema, and papular lichenoid variants.

[0049] 2. Traditional Chinese medicine diagnostic / syndrome type criteria: The diagnostic criteria for "four bends wind" in the Traditional Chinese Medicine Industry Standard of the People's Republic of China, "Standards for Diagnosis and Therapeutic Effect of Traditional Chinese Medicine Diseases and Syndromes" (ZY / T001.8-94): ① The skin lesion is characterized by dryness, roughness, thickening and lichenification, and may have acute or subacute dermatitis-like episodes. Spontaneous severe pruritus. ② The skin lesions tend to occur on the flexor sides of the elbow and knee joints, and may also be seen on the extensor sides of the calves, face and neck, perioral area and other sites. ③ There may be a history of infantile eczema, with repeated attacks that persist without recovery. ④ There is a genetic allergic predisposition, and the family members or the individual often have a history of asthma, urticaria and other conditions. ⑤ Serum IgE is elevated, and the eosinophil count in the blood routine is increased.

[0050] 3. Severity grading of atopic dermatitis: Investigator's Global Assessment (IGA), see Table 1 for details.

[0051] Table 1 Investigator's Global Assessment

[0052] S2. Inclusion criteria 1. 6 months ≤ age ≤ 12 years, regardless of gender.

[0053] 2. Meeting the aforementioned diagnostic criteria for atopic dermatitis.

[0054] 3. IGA score of 2 to 3 points.

[0055] 4. The guardian has signed the informed consent form, and the child aged ≥ 8 years also needs to sign the informed consent form.

[0056] 5. Good compliance.

[0057] S3. Exclusion criteria 1. Have used the following within the past 30 days: glucocorticoids (systemic or potent topical preparations), immunosuppressants, any traditional Chinese medicine treatment.

[0058] 2. Diagnosed with the following diseases: scabies, allergic contact dermatitis, seborrheic dermatitis, psoriasis.

[0059] 3. Presence of serious underlying diseases: cardiovascular, liver or kidney dysfunction.

[0060] 4. Combined with other skin diseases that affect the assessment of disease severity.

[0061] 5. Individuals allergic to any of the ingredients in this formula.

[0062] S4. Rejection / Removal Standards 1. Treatment was discontinued or medications prohibited by the protocol were used during the study.

[0063] 2. Those whose incomplete data during treatment affects the assessment of efficacy.

[0064] 3. Patients who experience serious adverse events during treatment and are unable to continue treatment.

[0065] (2) Trial grouping and treatment methods Experimental grouping: The 102 children with atopic dermatitis selected above were randomly divided into an experimental group and a positive control group, with 51 cases in each group, using a random number table method.

[0066] Treatment methods: Both the experimental group and the positive control group received the same basic treatment, including appropriate bathing frequency and the use of moisturizing agents. The positive control group received routine drug treatment: oral desloratadine dry suspension (commercially available product, dosage and administration shown in Table 2), and topical zinc oxide oil (purchased from Beijing Shuangji Pharmaceutical Co., Ltd., National Drug Approval Number H11022229, specification 10g / tube, applied to the affected area twice daily), for a course of 4 weeks. The treatment group received the traditional Chinese medicine wash prepared in Example 1, applied as a wet compress for 10 minutes each time, twice a day, for a course of 4 weeks.

[0067] Table 2. Dosage and Administration of Desloratadine Dry Suspension

[0068] (3) Observation indicators: 3.1 General information: Patient's name, gender, age, etc.

[0069] 3.2 Efficacy indicators: IGA scores before and after treatment (primary indicator).

[0070] 3.3 Safety indicators: adverse reaction records.

[0071] (4) Evaluation of efficacy: IGA success rate after 4 weeks of treatment. IGA success rate is the proportion of patients with an IGA score of 0 (complete clearance of skin lesions) or 1 (almost complete clearance) and a decrease of ≥2 points from baseline.

[0072] (5) Statistical analysis: SPSS 26.0 software was used for data analysis. First, normality tests and homogeneity of variance analyses were performed on the continuous data. If the data conformed to a normal distribution and had homogeneity of variance, a t-test was selected for analysis, and the results were expressed as mean ± standard deviation. The independent samples t-test was used for comparisons between two groups, and the paired samples t-test was used for comparisons before and after treatment within a group. For data that did not conform to a normal distribution or were ordinal data, the rank-sum test was used, and the results were expressed as median and interquartile range. The chi-square test was used for categorical data, and p < 0.05 was considered statistically significant.

[0073] (6) Results 6.1 General Information This study included 102 subjects, who were randomly divided into an experimental group and a control group, with 51 subjects in each group. The comparison of gender and age is shown in Table 3.

[0074] In the experimental group, there were 22 males (43.1%) and 29 females (56.9%); in the positive control group, there were 23 males (45.1%) and 28 females (54.9%). The chi-square test was used to compare the gender composition between the two groups, and the difference was not statistically significant (χ²). 2 =0.04, p=0.84), and the genders of the two groups were comparable. There were no statistically significant differences in gender or age between the two groups (p>0.05).

[0075] Because the age data of both groups were not normally distributed, a nonparametric rank-sum test was used for comparison between the groups. The results showed that the median age in the experimental group was 48 months (P25~P75: 12, 72), and the median age in the positive control group was 47 months (P25~P75: 15, 72), with no statistically significant difference (Z=-0.764, p=0.445), indicating comparability.

[0076] Table 3 General Information of Subjects

[0077] 6.2 Baseline Status Investigator Overall Assessment (IGA) The mean IGA scores (SD) of the experimental group and the positive control group before treatment (baseline period) were 2.61±0.49 and 2.55±0.50, respectively (see Table 4 for details). The rank-sum test was used to compare the two groups. There was no statistically significant difference in the IGA scores at the baseline period (Z=-0.512, P=0.609), so they were comparable.

[0078] Table 4. Baseline IGA scores for different groups

[0079] 6.3 Comparison of observation indicators after treatment 6.3.1 Investigator Global Assessment (IGA) before and after treatment The results in Table 5 show that the IGA scores of both the experimental group and the positive control group decreased significantly after treatment, with the IGA score of the experimental group being significantly lower than that of the positive control group after treatment. The mean IGA scores (SD) before and after treatment in the experimental group were 2.61±0.49 and 1.15±0.99, respectively, with a statistically significant difference (t=9.73, p<0.001). The mean IGA scores (SD) before and after treatment in the positive control group were 2.55±0.50 and 1.53±0.95, respectively, with a statistically significant difference (t=7.83, p<0.001).

[0080] As shown in Table 5, among the 51 patients with mild to moderate symptoms, 37 patients had IGA scores that became 0 or 1 after treatment with the traditional Chinese medicine wash solution of this invention, while among the 30 patients in the positive control group, IGA scores that became 0 or 1 after treatment with the positive drug.

[0081] After 4 weeks of treatment, the success rates of IGA (the proportion of patients with an IGA score of 0 (complete clearance of lesions) or 1 (almost complete clearance) and a decrease of ≥2 points from baseline) in the experimental group and the positive control group were 52.9% (27 / 51) and 31.4% (16 / 51), respectively. The chi-square test was used to compare the two groups, and the difference was statistically significant (χ²). 2 =4.86, p= 0.027).

[0082] In addition, during the consultation and treatment observation period, after 4 weeks of treatment, the herbal wash of the present invention can effectively relieve itching, and the color of erythema on the skin, the degree of skin induration, the size and number of papules, and the degree of lichenification are all significantly reduced.

[0083] Table 5. IGA scores of different groups after 4 weeks of treatment

[0084] (7) Comparison of adverse reactions between the two groups During the treatment period, no gastrointestinal adverse reactions such as diarrhea, abdominal pain, nausea, or vomiting occurred in any of the subjects in the experimental group or the positive control group. No obvious local irritation or allergic reactions such as rash, redness, swelling, stinging, or local burning were observed. This invention has good drug safety.

[0085] Typical Case 1 Ms. Liao, a 6-year-old girl, presented with a 2-year history of recurrent erythema, papules, and vesicles accompanied by itching on both feet. A recurrence occurred one week prior, with subsequent desquamation and itching following the resolution of the erythema and papules. She was diagnosed with atopic dermatitis. She had previously used compound ketoconazole cream during flare-ups, but the condition recurred after discontinuation of the medication. At the initial consultation, she was scored using the Investigator Global Assessment (IGA) method as shown in Table 1, with an IGA score of 3. She was treated externally with the herbal wash prepared in Example 1, applied as a wet compress for 10 minutes each time, twice a day, for 4 weeks.

[0086] One week later, Liao's itching was significantly relieved. Figure 1 The results showed that after 4 weeks of treatment, the erythema and papules on the patient's feet significantly subsided, with no new papules, oozing, or crusting. It should be noted that the blood crust on the patient's third toe was found to be caused by accidental bleeding. Furthermore, the IGA score was performed 4 weeks after treatment, and the IGA score was 1 point.

[0087] Typical Case 2 Mr. Wang, a 6-year-old boy, had a 3-year history of atopic dermatitis, mainly presenting with recurrent erythema and papules accompanied by itching on the trunk and limbs. He had previously been treated with diphenhydramine hydrochloride cream and desloratadine dry suspension, but the condition recurred. At this visit, the patient presented with dry, scaly skin and itching on his right foot. At the initial consultation, his Investigator Global Assessment (IGA) score was 3 points. He was treated externally with the herbal wash prepared in Example 1, applied as a wet compress for 10 minutes each time, twice a day, for 2 weeks.

[0088] Figure 2 The results showed that after two weeks of treatment, the patient's foot symptoms significantly improved, the thickened and lichenified skin on the feet subsided, the skin regained its softness and elasticity, and the dryness and scaling of the skin were significantly reduced. Furthermore, the patient's itching symptoms decreased significantly upon inquiry. After two weeks of treatment, the patient's IGA score was 1.

[0089] 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 atopic dermatitis, characterized in that, Including the following parts by weight of raw materials: 15-25 parts of Schizonepeta tenuifolia spike, 25-35 parts of Saposhnikovia divaricata, 15-25 parts of Mustard seed, 15-25 parts of Notopterygium incisum, 15-25 parts of Stemona japonica, 25-35 parts of Dictamnus dasycarpus root bark, 15-25 parts of Sophora flavescens, 15-25 parts of Plumeria rubra, 5-15 parts of Hibiscus mutabilis leaf, and 5-15 parts of Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, Including the following parts by weight of raw materials: 17-23 parts of Schizonepeta tenuifolia spike, 26-32 parts of Saposhnikovia divaricata, 17-24 parts of Mustard seed, 16-24 parts of Notopterygium incisum, 17-22 parts of Stemona japonica, 27-34 parts of Dictamnus dasycarpus root bark, 17-24 parts of Sophora flavescens root, 16-24 parts of Plumeria rubra flower, 7-13 parts of Hibiscus mutabilis leaf, and 7-13 parts of Glycyrrhiza uralensis.

3. The method for preparing the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, Includes the following steps: Mix the aforementioned Stemona japonica, Dictamnus dasycarpus, Sophora flavescens, Sinapis alba, and Glycyrrhiza uralensis, then mix with water, soak, boil, and decoct for the first time. Then add the aforementioned Schizonepeta tenuifolia, Saposhnikovia divaricata, and Notopterygium incisum, and continue to decoct for the second time. Finally, add the aforementioned Frangipani and Hibiscus mutabilis leaves, and continue to decoct for the third time. Filter, collect the filtrate, and obtain the aforementioned traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that, The soaking method is to soak at 20~25℃ for 25~35 minutes.

5. The preparation method according to claim 3, characterized in that, The raw material mixture consists of the following ingredients: catnip spike, saposhnikovia root, mustard seed, notopterygium root, stemona root, dictamnus root bark, sophora root, frangipani flower, hibiscus leaf, and licorice root; the mass-to-volume ratio of the raw material mixture to water is 1g:20~30mL.

6. The preparation method according to claim 3, characterized in that, The first decoction is simmered over low heat for 15-25 minutes, the second decoction is simmered over low heat for 8-12 minutes, and the third decoction is simmered over low heat for 4-7 minutes.

7. The traditional Chinese medicine composition prepared by the preparation method according to any one of claims 3 to 6.

8. The use of the traditional Chinese medicine composition according to claim 1 or 2, or the traditional Chinese medicine composition according to claim 7, in the preparation of atopic dermatitis drugs.

9. The application according to claim 8, characterized in that, The atopic dermatitis mentioned refers to childhood atopic dermatitis.

10. The application according to claim 8, characterized in that, The drug also includes pharmaceutically acceptable excipients.

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