A Kampo medicine composition for treating childhood atopic dermatitis and a method for preparing the same.

Abstract

This application provides a Kampo (traditional Japanese herbal medicine) composition for treating childhood atopic dermatitis and a method for preparing the same, relating to the technical field of Kampo compositions. [Solution] The raw materials of the herbal medicine composition include 4-8 parts of Atractylodes lancea, 6-10 parts of Lonicera japonica, 4-8 parts of Phellodendron bark, 4-8 parts of Coix seed, 4-8 parts of Achyranthes bidentata, 2-8 parts of Sophora flavescens, 4-8 parts of Bletilla striata, 4-8 parts of Rehmannia glutinosa, 2-8 parts of Cicada rotundifolia, and 2-8 parts of Glycyrrhiza uralensis. The preparation method involves adding water to the herbal medicine and immersing it, then heating and reflux extraction, filtering, taking the filtrate, concentrating the filtrate to make a clear ointment, cooling, adding ethanol, letting it stand, taking the supernatant liquid and recovering the ethanol, then secondary concentration to obtain a herbal medicine paste, and finally granulating the herbal medicine paste. This invention combines traditional herbal medicine with modern pharmacological action to achieve the effects of clearing heat and removing dampness, strengthening the spleen and removing dampness, and dispelling wind and relieving itching. In actual application, it shows remarkable improvement and complete cure in the symptoms of childhood atopic dermatitis, with a rapid effect, a short treatment process, low side effects, and no recurrence after complete cure.

Description

Technical Field

[0001] This application relates to the technical field of traditional Chinese medicine compositions, and specifically to a traditional Chinese medicine composition for treating pediatric atopic dermatitis and a method for preparing the same.

Background Art

[0002] Pediatric atopic dermatitis (AD) is also called "heterotopic dermatitis", "hereditary allergic dermatitis", "heterotopic eczema", "atopic eczema or skin inflammation syndrome (atopic eczema dermatitis syndrome, AEDS)", etc. It is a chronic, recurrent, inflammatory skin disease related to hereditary allergic constitution. Clinically, it shows itching, polymorphic skin damage, has an exudative tendency, often accompanies asthma and allergic rhinitis, and its characteristic is the obvious "atopy" in the patient or the family. The incidence rate of children worldwide is about 10% - 20%, and the incidence rate of adults is about 1% - 3%, and the incidence rate shows an increasing trend year by year. Pediatric atopic dermatitis is prone to repeated attacks of the disease condition and is difficult to cure, thus greatly affecting the physical and mental health and quality of life of patients.

[0003] The pathogenesis of pediatric atopic dermatitis is relatively complex. In Western medicine, it is considered that the main pathogenesis is the imbalance in the ratio between Th1 cells and Th2 cells. From the previous research on the acute phase of AD, it can be seen that peripheral blood of AD patients has a dual expression mode of Th1 / Th2 cytokines. IL-4 is one of the most important cytokines of Th2, and its overexpression can cause typical clinical manifestations of AD. It has been proved that IL-31 can induce the expression of various eczema-related chemokines, and it is also an important cytokine that induces skin inflammation and itching. Therefore, the recognized treatment methods for AD in modern medicine mainly include antihistamine drugs, glucocorticoids, antimicrobial agents, immunosuppressive agents, etc. However, various side effects and adverse reactions reduce the compliance of patients with long-term medication, and the long-term treatment effect is not ideal.

[0004] Traditional Chinese medicine has a long history, remarkable therapeutic effects, and few adverse reactions. In recent years, with the increasing attention given to traditional Chinese medicine worldwide, traditional Chinese medicine has made some progress in the treatment of Alzheimer's disease (AD). Many publications and patents disclose that relevant traditional Chinese medicine prescriptions are used to treat childhood atopic dermatitis. However, it also has shortcomings such as poor therapeutic effects, a high recurrence rate, and a long treatment cycle. Therefore, developing traditional Chinese medicine formulations that can improve these shortcomings is of great significance. [Overview of the project]

[0005] The object of this application is to provide a Kampo medicine composition for treating childhood atopic dermatitis and a method for preparing the same, wherein the product has the advantages of rapid therapeutic effect on childhood atopic dermatitis, few side effects, and no recurrence after discontinuation of the drug, and the raw materials used are inexpensive and the preparation method is simple.

[0006] To solve the above technical problems, the technical solutions adopted in this application are as follows:

[0007] In one embodiment, the present application provides a Kampo medicine composition for treating childhood atopic dermatitis, comprising, by weight, 4-8 parts of Atractylodes lancea, 6-10 parts of Lonicera japonica, 4-8 parts of Phellodendron amurense, 4-8 parts of Coix seed, 4-8 parts of Achyranthes bidentata, 2-8 parts of Sophora flavescens, 4-8 parts of Platycerium erythrostictum, 4-8 parts of Rehmannia glutinosa, 2-8 parts of Cicada rotundifolia, and 2-8 parts of Glycyrrhiza uralensis.

[0008] In another embodiment, the present application, Step S1: After adding water to the herbal medicine and steeping it, the process involves heating, reflux extraction, filtration, and obtaining the filtrate. Step S2: Concentrate the filtrate to make a clear ointment, cool it, add ethanol, let it stand, take the supernatant liquid to recover the ethanol, then perform secondary concentration to obtain a herbal medicine paste, granulate the herbal medicine paste to obtain the herbal medicine composition product for treating the aforementioned childhood atopic dermatitis. This invention provides a method for preparing a Kampo medicine composition for treating childhood atopic dermatitis, which includes [specific ingredient / component].

[0009] Atractylodes lancea: This plant has an irregular, bead-like or nodular cylindrical shape, is slightly curved, occasionally branched, and measures 3-10 cm in length and 1-2 cm in diameter. The surface is grayish-brown, with wrinkles, transverse curves, and remnants of fibrous roots, and has a stem scar or remnants of stem base at the tip. It is solid, with a yellowish-white or grayish-white cross-section, and many orange or brown oil chambers scattered throughout. After exposure for a while, fine, white, needle-like crystals precipitate. It has a distinctive aroma and a slightly sweet, pungent, and bitter taste.

[0010] Honeysuckle: This plant is rod-shaped, thicker at the top and thinner at the bottom, slightly curved, 2-3 cm long, with an upper diameter of approximately 3 mm and a lower diameter of approximately 1.5 mm. The surface is yellowish-white or greenish-white (the color gradually deepens with prolonged exposure) and densely covered with short, soft hairs. Leaf-like bracts are commonly seen. The calyx is green, with a 5-lobed tip and hairy lobes, approximately 2 mm long. The open corolla is tubular, with two lip-shaped tips, 5 stamens attached to the tubular wall, yellow, with one pistil and a glabrous ovary. It has a mild fragrance and a faint, slightly bitter taste.

[0011] Phellodendron amurense: This specimen is plate-like or shallowly grooved, with varying lengths and widths, and a thickness of 1-6 mm. The outer surface is yellowish-brown or yellowish-brown, flat or with longitudinal grooves, with visible pores and residual grayish-brown rough bark. The inner surface is dark yellow or light brown with dense longitudinal ridges. The body is light, hard, fibrous in cross-section, and fragmented in layers, and is dark yellow. It has a slight odor, a very bitter taste, and a viscous texture when chewed.

[0012] Coix seed: This product is broadly ovate or oblong, 4-8 mm long and 3-6 mm wide. The surface is milky white and smooth, with occasional remnants of yellowish-brown seed coat. One end is bluntly rounded, the other end is broad and slightly concave, and there is a single faint brown dot-like hilum. The dorsal surface is rounded, and the ventral surface has a single broad, deep longitudinal groove. It is solid, with a white, powdery cross-section. It has a slight odor and a slightly sweet taste.

[0013] Achyranthes bidentata (Posterior): This specimen is slender and cylindrical, straight or slightly curved, 15-70 cm long and 0.4-1 cm in diameter. The surface is grayish-yellow or light brown, with fine, slightly twisted longitudinal wrinkles, sparsely arranged lateral root scars, and transverse pore-like projections. It is hard and brittle, easily broken, and becomes soft after becoming wet. The cross-section is flat, light brown, and slightly oily with a keratinous texture. The woody part of the central vascular bundle is large and yellowish-white, with numerous yellowish-white, dot-like vascular bundles scattered around its circumference, arranged intermittently in 2-4 rings. It has a slight odor and a slightly sweet and slightly bitter taste.

[0014] Sophora flavescens: This plant is long and cylindrical, with branching at the base, measuring 10-30 cm in length and 1-6.5 cm in diameter. The surface is grayish-brown or brownish-yellow, with longitudinal wrinkles and transverse pore-like projections. The outer skin is thin, easily ruptured and recurved, and peels off easily. The peeled areas are yellow and smooth. It is hard, not easily broken, and has a fibrous cross-section. Slices are 3-6 mm thick, with a yellowish-white cut surface, radial patterns and fissures, and irregularly shaped vascular bundles are scattered concentrically or irregularly. It has a slight odor and a very bitter taste.

[0015] White-skinned: This product is rolled, 5-15 cm long, 1-2 cm in diameter, and 0.2-0.5 cm thick. The outer surface is grayish-white or pale grayish-yellow, with fine vertical wrinkles and thin root scars, and many small, protruding granular dots. The inner surface is mostly white with fine vertical stripes. The quality is brittle, and when broken, dust is released. The cross-section is not flat but somewhat layered, and the outer layer peels off, revealing small, flashing bright spots that catch the light. It has a goaty taste and is slightly bitter.

[0016] Peeling: This fruit has a flattened, spherical, pentagonal shape, with a diameter of 1-3 mm. It is covered with a residual perianth, which is grayish-green or light brown on the surface, has five small membranous fins around the periphery, and on the underside there is a minute projection, a punctate fruit pedicel in the center, with 5-10 radial veins. When the perianth is peeled away, the membranous pericarp is visible and is semi-transparent. The seeds are flattened, oval, about 1 mm long, and black. They have a slight odor and a slightly bitter taste.

[0017] Cicada shell: This specimen is roughly oval-shaped, approximately 3.5 cm long and 2 cm wide. Its surface is yellowish-brown, translucent, and glossy. The head has a pair of filiform antennae, most of which are detached, and the compound eyes protrude. The tip of the forehead protrudes, the kiss is well-developed, the upper lip is short, and the lower lip is elongated into a tube. The dorsal surface of the thorax is cruciform, the slits curl inward, there are two small wings on each side of the back, and there are three pairs of legs on the ventral surface, covered with fine yellowish-brown hairs. The abdomen is blunt and has a total of nine segments. The body is light, hollow, and fragile. It has a slight odor and a mild taste.

[0018] Licorice: The roots of this plant are cylindrical, 25-100 cm long and 0.6-3.5 cm in diameter. The looseness of the outer covering varies. The surface is reddish-brown or grayish-brown with prominent longitudinal wrinkles, grooves, pores, and sparse root scars. It is solid, with a slightly fibrous, yellowish-white, powdery cross-section, prominent ring formations that are radial, and cracked. The rhizome is cylindrical, with bud scars on the surface and pith in the center of the cross-section. It has a slight odor and a sweet, distinctive taste.

[0019] In this application, the etiology and pathology of childhood atopic dermatitis is considered to be due to the child's weakness, the inability of the spleen to function normally, internal fire and damp-heat, and external wind-dampness and heat pathogens, both of which obstruct the skin. The exudative type occurs frequently in obese children, with wetness being more severe than heat, while the dry type is often seen in thin or elderly children, with heat being more severe than wetness. Acute stage: fetal inflammation and damp-heat; subacute stage: spleen dysfunction and internal damp-heat; chronic stage: qi and blood are not properly moistened, and wind pathogens are present. Damp-heat is always the dominant factor. Treatment method: clear heat and dispel dampness, strengthen the spleen and dispel dampness, dispel wind and relieve itching.

[0020] Therefore, the principle of this preparation is that Atractylodes lancea, Phellodendron bark, and Lonicera japonica are the principal herbs. Atractylodes lancea is bitter and warm, and can dry dampness in the spleen and create coldness. Phellodendron bark is bitter and cold, and its bitterness can dry dampness, and its coldness can remove heat. Lonicera japonica is sweet and cold, and is a common antipyretic and detoxifying drug used in surgery. The secondary herbs are Coix seed, Achyranthes bidentata, and Sophora flavescens. Coix seed is sweet, pale, slightly cold, pale and moist, and assists Atractylodes lancea in strengthening the spleen. Achyranthes bidentata is bitter, sour, neutral, and promotes diuresis and urination, and lowers damp-heat winds. Sophora flavescens is bitter, cold, removes heat, dries dampness, removes wind, and kills insects, making it a drug for treating various skin diseases, and modern pharmacological research indicates it has anti-allergic effects. The auxiliary herbs are Bletilla striata, Rhizome, Cicada sprouts, and Glycyrrhiza uralensis. White sprouts and Difuzi can both remove heat and dry dampness, and can also relieve wind and itchiness. Cicada's quince releases heat from wind, relieves wind and itchiness, and has a sedative effect. Modern pharmacological research indicates that it has anti-allergic and immunosuppressive effects. Licorice is used to prepare these medicines.

[0021] Based on the mechanism described above, the product of this application can also be used to treat conditions such as purpura, infantile eczema, suppurative cutaneous acne, oral ulcers, and adenoid hypertrophy in children.

[0022] Compared to the prior art, the embodiments of this application have at least the following advantages or beneficial effects.

[0023] Theoretically, this invention uses Atractylodes lancea, Phellodendron amurense, and Lonicera japonica as principal herbs, Coix lacryma-jobi, Achyranthes bidentata, and Sophora flavescens as secondary herbs, and White bark, Rehmannia glutinosa, Cicada sprouts, and Glycyrrhiza uralensis as auxiliary herbs, combining traditional Chinese medicine with modern pharmacological effects to eliminate heat and dampness, promote spleen health, and prevent itching caused by wind. In actual application, it shows remarkable improvement in the healing status of atopic dermatitis symptoms in children, with rapid effects, a short treatment process, few side effects, and no recurrence, resulting in a clinically favorable experience for such patients. [Modes for carrying out the invention]

[0024] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions in the embodiments of this application will be described clearly and completely below. For those not specifying specific conditions in the embodiments, operations were performed according to normal conditions or conditions proposed by the manufacturer. For reagents or equipment used where the manufacturer is not specified, all are ordinary products obtained commercially.

[0025] Unless there is a contradiction, the embodiments of this application and the features of the embodiments can be combined with each other. The following will describe this application in detail with reference to specific embodiments.

[0026] A Chinese medicine composition for treating pediatric atopic dermatitis, comprising Chinese medicine raw materials of 4 - 8 parts of Atractylodes lancea, 6 - 10 parts of Lonicera japonica, 4 - 8 parts of Phellodendron amurense, 4 - 8 parts of Forsythia suspensa, 4 - 8 parts of Achyranthes bidentata, 2 - 8 parts of Sophora flavescens, 4 - 8 parts of Dictamnus dasycarpus, 4 - 8 parts of Kochia scoparia, 2 - 8 parts of Cryptotympana pustulata, and 2 - 8 parts of Glycyrrhiza uralensis by weight.

[0027] In some embodiments of this application, the above Chinese medicine composition comprises Chinese medicine raw materials of 6 parts of Atractylodes lancea, 8 parts of Lonicera japonica, 6 parts of Phellodendron amurense, 6 parts of Forsythia suspensa, 6 parts of Achyranthes bidentata, 5 parts of Sophora flavescens, 6 parts of Dictamnus dasycarpus, 6 parts of Kochia scoparia, 5 parts of Cryptotympana pustulata, and 5 parts of Glycyrrhiza uralensis.

[0028] In some embodiments of this application, the above Achyranthes bidentata is Radix Achyranthis Bidentatae.

[0029] A method for preparing a Chinese medicine composition for treating pediatric atopic dermatitis, comprising: S1, adding water to the Chinese medicine for immersion, then performing heating reflux extraction, filtering, and taking out the filtrate; S2, concentrating the filtrate into a clear extract, adding ethanol after cooling, standing, taking the supernatant and recovering the ethanol, then performing secondary concentration to obtain a Chinese medicine paste, granulating the Chinese medicine paste, and obtaining the product of the Chinese medicine composition for treating pediatric atopic dermatitis.

[0030] In some embodiments of the present invention, in step S1, the ratio of the medicinal material to the water added is 1:(6-14), the immersion temperature is room temperature, the immersion time is 0.5-3h, the number of heating reflux extractions is 2, each for 1-3h, and the two filtrates are combined before the concentration treatment in step S2.

[0031] In some embodiments of the present invention, in step S2 above, vacuum concentration is employed, the vacuum level for concentration is -0.09 MPa to -0.04 MPa, the concentration temperature is 60-80°C, and the relative density of the concentrated ointment is 1.10-1.25.

[0032] In some embodiments of the present invention, the alcohol content after adding ethanol in step S2 is 30-80%, and the standing time is 8-48 hours.

[0033] In some embodiments of the present invention, the secondary concentration in step S2 is performed using reduced-pressure concentration, and the concentrated herbal medicine paste is a condensed paste with a relative density of 1.25-1.36. An auxiliary agent is added to the condensed paste, and it is uniformly mixed to prepare granules, which are then dried to obtain a herbal medicine composition product.

[0034] In some embodiments of the present application, the above-mentioned auxiliary agent includes a sweetener, a flavoring agent and / or a bitterness inhibitor.

[0035] Examples of sweeteners include glucose, fructose, sucrose, starch syrup, xylitol, monosyrup, fruit juice syrup, honey, steviolin, sorbitol, mannitol, D-tagatose, steviose, aspartame, saccharin, steviotin, asparagine, acesulfame, aspartame, neotame, sucralose, isomalt, and oligosaccharides (fructooligosaccharides).

[0036] Examples of fragrances include peppermint oil, cinnamon oil, anise oil, peppermint water, anhydrous cardamom, banana essence, pineapple essence, mandarin orange essence, lemon essence, chocolate essence, glucose essence, red apple essence, strawberry essence, and peach essence.

[0037] Examples of bitterness inhibitors include caffeic acid, ferulic acid, citric acid, adenosine monophosphate, phosphatidic acid, protein-phosphatidic acid complex, tannic acid, and neodiosmin.

[0038] In some embodiments of the present invention, the secondary concentration in step S2 is performed using reduced-pressure concentration, and the concentrated herbal medicine paste is a clear ointment with a relative density of 1.05-1.25. The clear ointment is then granulated in one step and dried to obtain a herbal medicine composition product.

[0039] The features and performance of this application will be described in more detail below with reference to the examples. [Examples]

[0040] [Example 1] This embodiment provides a Kampo medicine composition for treating childhood atopic dermatitis, and its preparation method is as follows. S1. Weigh out 6g of Atractylodes lancea, 8g of Lonicera japonica, 6g of Phellodendron amurense, 6g of Coix seed, 6g of Achyranthes bidentata, 5g of Sophora flavescens, 6g of Bletilla striata, 6g of Rhizome, 5g of Cicada rotundifolia, and 5g of Glycyrrhiza uralensis. Add 10 times the amount of water and steep for 2 hours. Extract twice by heating and refluxing, filtering for 2 hours each time, and combine the two filtrates. S2. The filtrate is concentrated under reduced pressure to a concentrated paste at a temperature of 75°C, a concentration vacuum of -0.06 MPa, and a relative density of 1.15. After cooling, ethanol is added to the paste to make the alcohol content 55%, and after mixing until uniform, it is allowed to stand for 24 hours. The supernatant is taken, filtered, and the ethanol is recovered from the filtrate. Subsequently, it is concentrated under reduced pressure to a concentrated paste with a relative density of 1.28, at a temperature of 70°C and a concentration vacuum of -0.06 MPa during this step. S3: Sweeteners and fragrances, which are common auxiliary agents, were added to the above concentrated paste, mixed uniformly to produce granules, dried, and sized to obtain the result.

[0041] [Example 2] This embodiment provides a Kampo medicine composition for treating childhood atopic dermatitis, and its preparation method is as follows. S1. Weigh out the following herbal medicine ingredients: Atractylodes lancea 8g, Lonicera japonica 6g, Phellodendron amurense 6g, Coix seed 8g, Achyranthes bidentata 5g, Sophora flavescens 6g, White bark 6g, Rehmannia glutinosa 6g, Cicada rot 6g, and Glycyrrhiza uralensis 3g. Add the above ingredients to 12 times the amount of water and steep for 1.5 hours. Heat and reflux extraction is performed twice for 2.5 hours each time, filtered, and the two filtrates are combined. S2. The filtrate is concentrated under reduced pressure to a concentrated paste with a concentration temperature of 65°C, a concentration vacuum of -0.04 MPa, and a relative density of 1.15. After cooling, ethanol is added to the paste to make the alcohol content 60%, and after mixing until uniform, it is allowed to stand for 36 hours. The supernatant is taken, filtered, and the ethanol is recovered from the filtrate. Then, it is concentrated under reduced pressure to a concentrated paste with a relative density of 1.25. In this step, the concentration temperature is 70°C and the concentration vacuum is -0.06 MPa. S3: Sweeteners and fragrances, which are common auxiliary agents, were added to the above concentrated paste, mixed uniformly to produce granules, dried, and sized to obtain the result.

[0042] [Example 3] This embodiment provides a Kampo medicine composition for treating childhood atopic dermatitis, and its preparation method is as follows. S1. Weigh out the following herbal medicine ingredients: Atractylodes lancea 8g, Lonicera japonica 8g, Phellodendron amurense 4g, Coix seed 4g, Achyranthes bidentata 5g, Sophora flavescens 8g, White bark 4g, Rehmannia glutinosa 8g, Cicada relics 6g, and Glycyrrhiza uralensis 4g. Add the above ingredients to 14 times the amount of water and steep for 1.5 hours. Heat and reflux extraction is performed twice for 3 hours each time, filtered, and the two filtrates are combined. S2. The filtrate is concentrated under reduced pressure to a concentrated paste with a concentration temperature of 65°C, a concentration vacuum of -0.04 MPa, and a relative density of 1.10. After cooling, ethanol is added to the paste to make the alcohol content 60%, and after mixing until uniform, it is allowed to stand for 36 hours. The supernatant is taken, filtered, and the ethanol is recovered from the filtrate. Then, it is concentrated under reduced pressure to a concentrated paste with a relative density of 1.35. In this step, the concentration temperature is 75°C and the concentration vacuum is -0.06 MPa. S3: The above concentrated paste was mixed uniformly with a bitterness inhibitor and a fragrance agent, which are common auxiliary agents, to produce granules, which were then dried and sized to obtain the granules.

[0043] [Example 4] This embodiment provides a Kampo medicine composition for treating childhood atopic dermatitis, and its preparation method is as follows. S1. Weigh out the following herbal ingredients: 7g of Atractylodes lancea, 10g of Lonicera japonica, 5g of Phellodendron amurense, 8g of Coix seed, 5g of Achyranthes bidentata, 6g of Sophora flavescens, 4g of Bletilla striata, 4g of Rhizome, 4g of Cicada rot, and 2g of Glycyrrhiza uralensis. Add the above ingredients to 9 times the amount of water and steep for 2 hours. Heat and reflux extraction is performed twice for 3 hours each time, then filter, and the two filtrates are combined. S2. The filtrate is concentrated under reduced pressure to a concentrated paste at a temperature of 80°C, a concentration vacuum of -0.09 MPa, and a relative density of 1.10. After cooling, ethanol is added to the paste to make the alcohol content 70%, and after mixing until uniform, it is allowed to stand for 12 hours. The supernatant is taken, filtered, and the ethanol is recovered from the filtrate. Subsequently, it is concentrated under reduced pressure to a concentrated paste with a relative density of 1.32, at a temperature of 75°C and a concentration vacuum of -0.08 MPa during this step. S3: The above concentrated paste was mixed uniformly with a bitterness inhibitor and a fragrance agent, which are common auxiliary agents, to produce granules, which were then dried and sized to obtain the granules.

[0044] [Example 5] This embodiment provides a Kampo medicine composition for treating childhood atopic dermatitis, and its preparation method is as follows. S1 consists of 6g of Atractylodes lancea, 8g of Lonicera japonica, 6g of Phellodendron amurense, 6g of Coix seed, 6g of Achyranthes bidentata, 5g of Sophora flavescens, 6g of Bletilla striata, 6g of Rhizome, 5g of Cicada rotundifolia, and 5g of Glycyrrhiza uralensis. These ingredients are added to 10 times the amount of water and steeped for 2 hours. The mixture is then heated and refluxed twice for 2 hours each time, filtered, and the two filtrates are combined. S2. The filtrate is concentrated under reduced pressure to a plaster with a concentration temperature of 80°C, a concentration vacuum of -0.09 MPa, and a relative density of 1.12. After cooling, ethanol is added to the plaster to make the alcohol content 80%, and after mixing until uniform, it is left to stand for 12 hours. The supernatant is taken, filtered, and the ethanol is recovered from the filtrate. Then, it is concentrated under reduced pressure to a plaster with a relative density of 1.25, with a concentration temperature of 75°C and a concentration vacuum of -0.08 MPa. The plaster may be directly granulated in one step and dried beforehand.

[0045] [Example 6] This embodiment provides a Kampo medicine composition for treating childhood atopic dermatitis, and its preparation method is as follows. S1 consists of 8g of Atractylodes lancea, 7g of Lonicera japonica, 6g of Phellodendron amurense, 5g of Coix seed, 6g of Achyranthes bidentata, 5g of Sophora flavescens, 5g of Bletilla striata, 6g of Rhizome, 6g of Cicada rot, and 4g of Glycyrrhiza uralensis. These ingredients are added to 10 times the amount of water and steeped for 2 hours. The mixture is then heated and refluxed twice for 2 hours each time, filtered, and the two filtrates are combined. S2. The filtrate is concentrated under reduced pressure to a plaster with a concentration temperature of 70°C, a concentration vacuum of -0.06 MPa, and a relative density of 1.10. After cooling, ethanol is added to the plaster to make the alcohol content 90%, and after mixing until uniform, it is allowed to stand for 15 hours. The supernatant is taken, filtered, and the ethanol is recovered from the filtrate. Subsequently, it is concentrated under reduced pressure to a plaster with a relative density of 1.20, with a concentration temperature of 70°C and a concentration vacuum of -0.06 MPa. The plaster may be directly granulated in one step and dried beforehand.

[0046] [Example 7] This embodiment provides a Kampo medicine composition for treating childhood atopic dermatitis, and its preparation method is as follows. S1 consists of 8g of Atractylodes lancea, 6g of Lonicera japonica, 4g of Phellodendron amurense, 8g of Coix seed, 6g of Achyranthes bidentata, 4g of Sophora flavescens, 4g of Bletilla striata, 6g of Rhizome, 6g of Cicada rotundifolia, and 5g of Glycyrrhiza uralensis. These ingredients are added to 10 times the amount of water and steeped for 3 hours. The mixture is then heated and refluxed twice for 1.5 hours each time, filtered, and the two filtrates are combined. S2. The filtrate is concentrated under reduced pressure to a plaster with a concentration temperature of 70°C, a concentration vacuum of -0.07 MPa, and a relative density of 1.10. After cooling, ethanol is added to the plaster to make the alcohol content 90%, and after mixing until uniform, it is allowed to stand for 20 hours. The supernatant is taken, filtered, and the ethanol is recovered from the filtrate. Then, it is concentrated under reduced pressure to a plaster with a relative density of 1.10, with a concentration temperature of 70°C and a concentration vacuum of -0.07 MPa. The plaster may be directly granulated in one step and dried beforehand.

[0047] [Experimental Example 1] This experiment explored the effects of the herbal medicine composition prepared in Example 1 on DNCB-induced atopic dermatitis.

[0048] 1. Animals and group division: 60 BALB / C mice aged 6-8 weeks were adaptively reared for one week, then randomly divided into a normal group, a model group, a positive drug group, and low, medium, and high dose groups of the test substance, with 10 mice in each group.

[0049] 2. Modeling and Administration: After dividing the animals into groups, the dorsal skin of all animals was treated with depilation, covering an area of ​​2cm x 4cm. On day 1 of modeling, excluding the normal group, 150ul of 1% DNCB was applied to the dorsal area of ​​each remaining group, and 20ul of 1% DNCB was applied to the back of the right ear, for two consecutive days. On days 7, 9, 11, and 13 of modeling, excluding the normal group, 100ul of 0.2% DNCB solution was applied to the dorsal area of ​​each remaining group, and 10ul of 0.2% DNCB solution was applied to the back of the right ear to excite and maintain atopic dermatitis symptoms in the mice. Modeling success was defined as the appearance of edema and erythema on the dorsal skin of early-stage mice, with crusting and scratching, and the appearance of dark erythema and scaling on the dorsal skin of late-stage mice. From day 15 of the study, the normal group and the model group were administered the solvent, the positive drug group received 10 mg / kg of prednisolone intragastricly, and the test subject group received different doses of the test substance (low, medium, and high doses were 10 g / kg, 20 g / kg, and 40 g / kg of crude drug, respectively) for 14 consecutive days. After administration, the subjects were euthanized and samples were collected.

[0050] 3. Detection indicators: (1) Skin damage score: On day 14 after administration, the skin on the back of the mice was observed with the naked eye, and the degree of skin damage in the mice was scored by referring to the Clinical Atopic Dermatitis Integral (SCORAD) evaluation criteria. Criteria: Severe erythema, edema, scaling, and epidermal shedding were assigned a score of 3 minutes, moderate erythema, edema, scaling, and epidermal shedding were assigned a score of 2 minutes, mild erythema, edema, scaling, and epidermal shedding were assigned a score of 1 minute, and normal skin was assigned a score of 0 minutes.

[0051] (2) Detection of scratch count: The number of scratches on the 14th day after administration to mice was recorded. Mice were placed alone in a resting environment, and the number of times they scratched their ears, backs, and abdomens etc. within 30 minutes was recorded using a camera. One scratch was considered to be when the mouse lifted its hind leg, scratched its ears and abdomen etc. continuously, and then dropped its hind leg or licked it.

[0052] (3) Measurement of right ear thickness: After administration, the thickness of the right ear of each mouse was measured using calipers.

[0053] (4) Detection of spleen index and thymus index: After killing the mice, the spleen and thymus were removed and weighed. Spleen index = spleen weight (mg) / body weight (g) * 10, thymus index = thymus weight (mg) / body weight (g) * 10.

[0054] (5) Skin pathology examination: A suitable amount of skin was taken from the injured area on the back of a mouse, fixed in a 4% paraformaldehyde solution for 24 hours, dehydrated by gradient in an ethanol solution for 5 minutes, cleared with xylene, embedded in paraffin, and cut into 4 μm thin sections. The sections were stained with hematoxylin and eosin, sealed with resin, and the pathological morphological changes of the sections were observed under a lens to assess the degree of epidermal proliferation, inflammation, and mast cell infiltration.

[0055] 4.Results: (1) Compared to the normal group, the model group showed clear erythema, edema, scaling, or epidermal shedding. Compared to the model group, the positive drug group and each test substance administration group showed improvement in skin damage, crusting of the skin, absence of erythema, absence of bleeding, normal hair growth, and a decrease in skin damage score.

[0056] (2) Compared to the normal group, the model group exhibited clear scratching behavior. Compared to the model group, the number of scratches in the positive drug group and each group administered the test substance was clearly reduced.

[0057] (3) Compared to the normal group, the thickness of the right ear in the model group was clearly increased. Compared to the model group, the thickness of the right ear in the positive drug group and each group administered the test substance was clearly decreased, and edema was reduced.

[0058] (4) Compared to the normal group, the thymic index and splenic index were clearly elevated in the model group. Compared to the model group, the thymic index and splenic index were decreased in the positive drug group and each group administered the test substance. The elevation of the splenic index may be related to hyperactivated B lymphocytes.

[0059] (5) In the normal group of mice, the thickness of the skin tissue was normal, the layers were clear, the structure of hair follicles and sebaceous glands in the dermis was complete, and there was no obvious edema or inflammatory cell infiltration. In the model group of mice, the epidermis was clearly thickened, the sebaceous glands were reduced, no aligned hair follicles were observed, epidermal cells were necrotic, sloughed off, disintegrated, or missing, the intercellular spaces and layers were unclear, epidermal cell keratinization was incomplete / excessive, the density was poor, cell nucleus rigidity was observed in the stratum corneum, inflammatory cell infiltration was observed in the dermis, and epidermal projections extended downward. After administration, the epidermal structure of the mice's skin was complete but increased in thickness, slight eosinophil and lymphocyte infiltration was observed in the dermis, skin keratinization was incompletely improved, cell nuclei remained in the thickened keratinized layer, the granular layer was unclear, and there was a clear improvement in the skin.

[0060] 5. Conclusion: The herbal medicine composition of the present invention significantly reduces the number of scratches in mice with atopic dermatitis, suppresses skin itching, alleviates erythema, edema, and skin inflammation caused by atopic dermatitis, and has a therapeutic effect on mouse atopic dermatitis.

[0061] [Experimental Example 2] The herbal medicine composition prepared in Example 1 of this application will be applied clinically.

[0062] 1. Research subject The herbal medicine composition was applied to 60 clinical observation cases (28 men and 32 women). The patients were randomly divided into a treatment group of 30 and a control group of 30, with ages ranging from 2 to 18 years and disease progression from 2 to 14 years. Of these, 12 had a clear history of genetic allergy.

[0063] 2. Diagnosis Western physician diagnostic criteria Referring to the diagnostic criteria for AD in the Williams diagnostic criteria, the main features are as follows: a history of itchy skin, plus three or more of the following: (1) a history of fatigue on the flexor skin, including the cubital fossa, popliteal fossa, anterior ankle, or around the neck; (2) visible dermatitis on the flexor side; (3) onset before the age of two; (4) a history of asthma or allergic rhinitis; (5) a history of generalized dry skin.

[0064] Traditional Chinese Medicine Diagnostic Criteria According to the diagnostic criteria for eczema in the "Diagnostic and Effectiveness Criteria for Diseases Caused by Traditional Chinese Medicine" issued by the State Administration of Traditional Chinese Medicine, eczema is a skin disease characterized by a clinically symmetrical distribution, multiform skin lesions, exudation and oozing, acute itching, and recurrent attacks, resulting from poor physical condition and the invasion of wind-damp-heat pathogens into the skin.

[0065] 3, Dosage Treatment group: The drug prepared from the herbal medicine composition of the present invention was administered after being washed with warm water. Patients weighing 50 kg or more were administered the prescribed dose, patients weighing 30-50 kg were administered 2 / 3 of the prescribed dose, and patients weighing 30 kg or less were administered 1 / 3 of the prescribed dose.

[0066] Control group: Crotadine syrup (Wante Pharmaceutical (Hainan) Co., Ltd., lot number H20070001) was administered orally. 5 ml was administered orally daily to subjects weighing ≤20 kg, and 10 ml was administered orally daily to subjects weighing >20 kg.

[0067] 4. Treatment effectiveness criteria 5. Referring to the criteria for the effectiveness of eczema in the "Criteria for the Diagnosis and Effectiveness of Traditional Chinese Medicine for Diseases" issued by the State Administration of Traditional Chinese Medicine, (1) Basically completely cured: all skin damage disappears, symptoms such as itching disappear, and the treatment effectiveness index is 90%-100%. (2) Remarkable effect: Most skin damage is reduced, itching is significantly reduced, and the therapeutic effect index is 70%-90%. (3) Effective: Skin damage is reduced, itching symptoms improve, and the therapeutic effect index is 30%-70%. (4) Ineffective: No clear reduction in skin damage, no reduction in itching, or worsening of clinical symptoms, and the treatment efficacy index is less than 30%. 6. 5. The treatment effects are shown in Table 1. 7, Table 1 [Table 1] Note: Total effectiveness rate = (Basically cured cases + Cases with significant improvement) / Total number of cases × 100% 8. 6. Typical Cases 9. Case 1: Mr. Xu, male, 12 years old. Chief complaint: Generalized scattered maculopapular rash for more than half a month. More than half a month prior to the onset, the child developed generalized erythematous maculopapular rash and itchiness without any apparent trigger. After taking four courses of medicine prepared from the herbal medicine composition of this invention, the color of the skin lesions faded, itchiness occurred occasionally, and no new rashes were observed. After continuing to take two courses, all skin lesions disappeared, symptoms such as itchiness disappeared, and the child was completely cured. 10. Case 2: Ye, male, 4 years old. Chief complaint: Generalized maculopapular eczema had been present for over six months. Erythematous papules were discovered on the facial skin, gradually resembling herpes, accompanied by itching, and after rupture, forming erosions, exudate, and scabs. Erythematous papules were scattered on the trunk and limbs, clearly accompanied by itching. Atopic dermatitis was diagnosed. After taking 8 courses of medicine prepared from the herbal medicine composition of this invention, the erythema faded, exudation from skin damage decreased significantly, and itching was reduced. After continuing to take 6 courses, the macules disappeared, the lesions diminished, the scabs fell off, and complete recovery was achieved. 11. The embodiments described above are only some, not all, embodiments of the present application. The detailed description of the embodiments of the present application is not intended to limit the scope of the protections sought by the present application, but rather to illustrate only the selected embodiments of the present application. All other embodiments obtained by a person skilled in the art without creative work based on the embodiments of the present application are within the scope of the protections of the present application.

Claims

1. A Kampo medicine composition for treating childhood atopic dermatitis, A Kampo medicine composition characterized by containing, by weight, 4-8 parts of Atractylodes lancea, 6-10 parts of Lonicera japonica, 4-8 parts of Phellodendron amurense, 4-8 parts of Coix seed, 4-8 parts of Achyranthes bidentata, 2-8 parts of Sophora flavescens, 4-8 parts of White bark, 4-8 parts of Rehmannia glutinosa, 2-8 parts of Cicada rotundifolia, and 2-8 parts of Glycyrrhiza uralensis.

2. A Kampo medicine composition for treating childhood atopic dermatitis according to claim 1, characterized by containing, by weight, 6 parts of Atractylodes lancea, 8 parts of Lonicera japonica, 6 parts of Phellodendron bark, 6 parts of Coix seed, 6 parts of Achyranthes bidentata, 5 parts of Sophora flavescens, 6 parts of White bark, 6 parts of Rehmannia glutinosa, 5 parts of Cicada rotundifolia, and 5 parts of Glycyrrhiza uralensis.

3. The herbal medicine composition for treating childhood atopic dermatitis according to claim 1, characterized in that the aforementioned Achyranthes bidentata is Achyranthes rotundifolia.

4. A method for preparing a Kampo medicine composition for treating childhood atopic dermatitis according to any one of claims 1 to 3, Step S1: After adding water to the herbal medicine and steeping it, the process involves heating, reflux extraction, filtration, and obtaining the filtrate. Step S2: Concentrate the filtrate to make a clear ointment, cool it, add ethanol, let it stand, take the supernatant liquid to recover the ethanol, then perform secondary concentration to obtain a herbal medicine paste, granulate the herbal medicine paste to obtain the herbal medicine composition product for treating the aforementioned childhood atopic dermatitis. A preparation method characterized by including the following.

5. A method for preparing a Kampo medicine composition for treating childhood atopic dermatitis according to claim 4, characterized in that in step S1, the addition ratio of the Kampo medicine to water is 1:(6-14), the immersion temperature is room temperature, the immersion time is 0.5-3h, the number of times heating reflux extraction is 2, each time for 1-3h, and the two filtrates are combined before the concentration treatment in step S2.

6. A method for preparing a Kampo medicine composition for treating childhood atopic dermatitis according to claim 5, characterized in that, in step S2, the concentration is performed using reduced pressure concentration, the vacuum level for concentration is -0.09 MPa to -0.04 MPa, the concentration temperature is 60-80°C, and the relative density of the concentrated ointment is 1.10-1.

25.

7. The method for preparing a Kampo medicine composition for treating childhood atopic dermatitis according to claim 4, characterized in that, in step S2, the alcohol content after adding ethanol is 30-80%, and the standing time is 8-48 hours.

8. The method for preparing a Kampo medicine composition for treating childhood atopic dermatitis according to claim 6, characterized in that, in step S2, secondary concentration is performed using vacuum concentration, the concentrated Kampo medicine paste is a condensed paste with a relative density of 1.25-1.36, an auxiliary agent is added to the condensed paste, it is uniformly mixed to produce granules, and dried to obtain a Kampo medicine composition product.

9. The method for preparing a Kampo medicine composition for treating childhood atopic dermatitis according to claim 8, characterized in that the aforementioned auxiliary agent comprises a sweetener, a fragrance agent and / or a bitterness inhibitor.

10. The method for preparing a Kampo medicine composition for treating childhood atopic dermatitis according to claim 6, characterized in that in step S2, secondary concentration is performed using vacuum concentration, the concentrated Kampo medicine paste is a clear ointment with a relative density of 1.05-1.25, the clear ointment is granulated in one step, and the product is dried to obtain a Kampo medicine composition product.

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