Traditional Chinese medicine composition for treating children atopic dermatitis and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating children atopic dermatitis and a preparation method thereof, and relates to the technical field of traditional Chinese medicine compositions. The traditional Chinese medicine composition comprises the following raw materials: 4-8 parts of rhizoma atractylodis, 6-10 parts of honeysuckle, 4-8 parts of cortex phellodendri, 4-8 parts of semen coicis, 4-8 parts of radix achyranthis bidentatae, 2-8 parts of radix sophorae flavescentis, 4-8 parts of cortex dictamni, 4-8 parts of fructus kochiae, 2-8 parts of cicada slough and The preparation method comprises the following steps: soaking the traditional Chinese medicinal materials in water, heating, refluxing, extracting, filtering and taking filtrate; concentrating the filtrate into clear paste, cooling, adding ethanol, standing, taking supernate, recovering ethanol, performing secondary concentration to obtain traditional Chinese medicine ointment, and granulating the traditional Chinese medicine ointment. The traditional Chinese medicine and modern pharmacological actions are combined to achieve the effects of clearing heat, eliminating dampness, tonifying spleen, excreting dampness, dispelling wind and arresting itching; in practical application, the traditional Chinese medicine composition has obvious improvement and cure conditions on children atopic dermatitis symptoms, and has the advantages of quick response, short curative effect, low side effect and no relapse after healing.

Description

Technical Field

[0001] The present application relates to the technical field of Chinese medicine compositions, and in particular, to a Chinese medicine composition for treating atopic dermatitis in children and a preparation method thereof. Background Art

[0002] Atopic dermatitis (AD) in children is also known as "atopic dermatitis", "genetic allergic dermatitis", "atopic eczema", "atopiceczema dermatitis syndrome (AEDS)", etc. It is a chronic, recurrent, inflammatory skin disease related to genetic allergic constitution. The clinical manifestations are itching, polymorphic skin lesions, and exudative tendency, often accompanied by asthma and allergic rhinitis-conjunctivitis. It is characterized by obvious "atopy" in the patient or family. The incidence rate in children worldwide is about 10% to 20%, and the incidence rate in adults is about 1% to 3%, and the incidence rate has a tendency to increase year by year. Atopic dermatitis in children is prone to recurrence and is difficult to cure, which has a great impact on the patient's physical and mental health and quality of life.

[0003] The pathogenesis of pediatric atopic dermatitis is relatively complex. From a Western medical perspective, its main pathogenesis is believed to be an imbalance between Th1 cells and Th2 cells. Previous studies on the acute phase of AD have found that AD patients have a dual expression pattern of Th1 / Th2 cytokines in their peripheral blood. IL-4 is one of the most important Th2 cytokines, and its overexpression can lead to typical clinical manifestations of AD. IL-31 has been shown to induce the expression of a variety of eczema-related chemokines, thereby inducing skin inflammation. It is also an important cytokine that induces itching. Therefore, modern medicine's recognized treatments for AD mainly include antihistamines, glucocorticoids, antimicrobial agents, and immunosuppressants. However, due to various side effects and adverse reactions, patients' compliance with long-term medication has decreased, and the long-term efficacy is not ideal.

[0004] Traditional Chinese medicine has a long history, outstanding efficacy and few adverse reactions. In recent years, with the increasing attention paid to traditional Chinese medicine around the world, traditional Chinese medicine has made certain progress in the treatment of AD. Many documents and patents have disclosed relevant traditional Chinese medicine formulas for the treatment of pediatric atopic dermatitis. However, there are also shortcomings such as poor efficacy, easy recurrence and long treatment cycle. Therefore, it is of great significance to develop a traditional Chinese medicine preparation that can improve the above defects. Summary of the invention

[0005] The purpose of the present application is to provide a Chinese medicine composition for treating pediatric atopic dermatitis and a preparation method thereof. The product has the advantages of rapid efficacy, small side effects, and no recurrence after drug discontinuation for pediatric atopic dermatitis, and the raw materials used are low in cost and the preparation method is simple.

[0006] In order to solve the above technical problems, the technical solution adopted in this application is:

[0007] On the one hand, the present application provides a traditional Chinese medicine composition for treating atopic dermatitis in children, which includes the following Chinese medicinal materials, measured by weight: 4-8 parts of Atractylodes lancea, 6-10 parts of Honeysuckle, 4-8 parts of Phellodendron chinense, 4-8 parts of Coix seeds, 4-8 parts of Achyranthes bidentata, 2-8 parts of Sophora flavescens, 4-8 parts of Dictamni cortex, 4-8 parts of Kochia scoparia, 2-8 parts of Periostracum cicadae, and 2-8 parts of Licorice.

[0008] On the other hand, the present application provides a method for preparing a Chinese medicine composition for treating atopic dermatitis in children, comprising the following steps:

[0009] S1, soaking the Chinese medicinal materials in water, then heating and refluxing for extraction, filtering, and taking the filtrate;

[0010] S2. Concentrate the filtrate into a clear paste, add ethanol after cooling, let it stand, take the supernatant and recover the ethanol, then concentrate it twice to obtain a Chinese medicine paste, granulate the Chinese medicine paste to obtain the Chinese medicine composition product for treating pediatric atopic dermatitis.

[0011] Atractylodes: This product is irregularly beaded or nodular cylindrical, slightly curved, occasionally branched, 3 to 10 cm long, 1 to 2 cm in diameter. The surface is gray-brown, with wrinkles, transverse lines and residual fibrous roots, with stem scars or residual stem bases at the top. The texture is solid, the cross section is yellow-white or gray-white, with many orange-yellow or brown-red oil chambers scattered. If exposed for a while, white fine needle-shaped crystals can be precipitated. The aroma is unique, and the taste is slightly sweet, spicy and bitter.

[0012] Honeysuckle: This product is stick-shaped, thick at the top and thin at the bottom, slightly curved, 2-3cm long, about 3mm in diameter at the top and about 1.5mm in diameter at the bottom. The surface is yellowish-white or greenish-white (the color gradually darkens with long storage), densely covered with short soft hairs. Leaf-like bracts are occasionally seen. The calyx is green, with 5 lobes at the tip, and the lobes are hairy and about 2mm long. The open corolla is tubular, with two lips at the tip; there are 5 stamens, attached to the wall of the tube, yellow; there is 1 pistil, and the ovary is glabrous. The smell is fresh, and the taste is light and slightly bitter.

[0013] Phellodendron chinense: This product is in the form of plates or shallow grooves, with different lengths and widths, and a thickness of 1 to 6 mm. The outer surface is yellow-brown or yellow-brown, flat or with longitudinal grooves, and some have visible lenticel marks and residual gray-brown rough skin; the inner surface is dark yellow or light brown, with fine longitudinal ridges. It is light, hard, fibrous in cross section, and flaky and layered, dark yellow. It has a slight odor, tastes extremely bitter, and is sticky when chewed.

[0014] Coix seeds: This product is broadly oval or oblong, 4-8mm long and 3-6mm wide. The surface is milky white and smooth, with occasional residual yellow-brown seed coat; one end is blunt and round, the other end is wider and slightly concave, with a light brown dot-shaped hilum; the back is round and convex, and the ventral surface has a wide and deep longitudinal groove. The texture is solid, the cross section is white, and the powder is fine. The smell is slight and the taste is slightly sweet.

[0015] Achyranthes bidentata (Huai): This product is slender and cylindrical, straight or slightly curved, 15 to 70 cm long, 0.4 to 1 cm in diameter. The surface is grayish yellow or light brown, with slightly twisted fine longitudinal wrinkles, sparsely arranged lateral root marks and transverse long lenticel-like protrusions. It is hard and brittle, easy to break, and becomes soft after being damp. The cross section is flat, light brown, slightly horny and oily. The central vascular bundle has a large yellow-white xylem, and its periphery is scattered with many yellow-white dot-like vascular bundles, which are intermittently arranged in 2 to 4 rounds. The smell is faint, and the taste is slightly sweet and slightly bitter.

[0016] Sophora flavescens: This product is long cylindrical, often with branches at the bottom, 10-30cm long, 1-6.5cm in diameter. The surface is gray-brown or brownish yellow, with longitudinal wrinkles and long horizontal lenticel-like protrusions. The outer skin is thin, often cracked and curled, easy to peel off, and the peeling part is yellow and smooth. It is hard and not easy to break. The cross section is fibrous; the slice thickness is 3-6mm; the cut surface is yellow-white, with radial texture and cracks, and some have heteromorphic vascular bundles in concentric rings or irregularly scattered. The smell is slight and the taste is very bitter.

[0017] Dictamni: This product is in the shape of a roll, 5-15cm long, 1-2cm in diameter, and 0.2-0.5cm thick. The outer surface is off-white or light grayish yellow, with fine longitudinal wrinkles and fine root marks, and often with protruding granular dots; the inner surface is off-white with fine longitudinal lines. It is brittle, and dust flies when broken. The cross section is uneven and slightly flaky. When the outer layer is peeled off, small flashing spots can be seen in the light. It has a sheep-like smell and tastes slightly bitter.

[0018] Kochia scoparia: This product is flat spherical five-pointed star-shaped, with a diameter of 1 to 3 mm. The outer layer is covered with persistent perianth, the surface is gray-green or light brown, surrounded by 5 small membranous wings, and there are slightly protruding dot-shaped fruit stalk marks and 5 to 10 radial veins in the center of the back; peel off the perianth, and you can see the membranous pericarp, which is translucent. The seeds are flat-ovate, about 1 mm long, and black. The smell is faint and the taste is slightly bitter.

[0019] Cicada molt: This product is slightly oval and curved, about 3.5cm long and 2cm wide. The surface is yellow-brown, translucent and shiny. There is a pair of filamentous antennae on the head, most of which have been broken off, and the compound eyes are prominent. The tip of the forehead is prominent, the muzzle is well-developed, the upper lip is wide and short, and the lower lip is elongated into a tube. The back of the chest is cross-shaped, the crack is curled inward, and there are 2 pairs of small wings on both sides of the back; there are 3 pairs of legs on the ventral side, covered with yellow-brown fine hairs. The abdomen is blunt and round, with a total of 9 segments. The body is light, hollow, and fragile. The smell is slight and the taste is light.

[0020] Licorice: The root of this product is cylindrical, 25-100cm long, 0.6-3.5cm in diameter. The outer skin is of varying tightness. The surface is reddish brown or grayish brown, with obvious longitudinal wrinkles, grooves, lenticels and sparse fine root marks. The texture is solid, the cross section is slightly fibrous, yellow-white, powdery, the cambium ring is obvious, the rays are radial, and some have cracks. The rhizome is cylindrical, with bud marks on the surface and pith in the middle of the cross section. The smell is slight, and the taste is sweet and special.

[0021] The present application believes that the etiology and pathology of pediatric atopic dermatitis are: children's endowment is intolerant, the spleen and stomach are inoperative, there is fetal fire dampness and heat inside, and rheumatism and heat outside, both of which block the skin. Exudative type, which often occurs in fat children, is more damp than hot; dry type, which is common in thin and elderly children, is more hot than damp. In the acute stage, there is fetal fire dampness and heat; in the subacute stage, the spleen is weak and cannot move, dampness and heat are internal; in the chronic stage, the qi and blood are not moistened, and the wind evil lingers. Dampness and heat are always the main ones. Treatment: clearing heat and dampness, strengthening the spleen and draining dampness, dispelling wind and relieving itching.

[0022] Therefore, the medication principle of this application is: in the prescription, Atractylodes, Phellodendron, and Honeysuckle are the main drugs. Atractylodes is bitter and warm, good at strengthening the spleen and drying dampness, and can assist in controlling the nature of coldness; Phellodendron is bitter and cold, bitter to dry dampness, cold to clear heat. Honeysuckle is sweet and cold, and is a commonly used heat-clearing and detoxifying drug in surgery. The assistant drugs are Coix seeds, Cyathula capitata, and Sophora flavescens. Coix seeds are sweet, light, slightly cold, and can penetrate dampness and help Atractylodes strengthen the spleen; Cyathula capitata is bitter, sour, and flat, and can promote diuresis and relieve stranguria, leading damp-heat evil downward; Sophora flavescens is bitter and cold, clears heat and dries dampness, dispels wind and kills insects, and is an important drug for treating various skin diseases. Modern pharmacological studies have shown anti-allergic effects. The assistant drugs are Dictamni, Kochia scoparia, Periostracum cicadae, and Licorice. Dictamni and Kochia scoparia can clear away heat and dampness, dispel wind and relieve itching; cicada shells can dissipate wind and heat, dispel wind and relieve itching and have a sedative effect; modern pharmacological research shows that they have anti-allergic and immunosuppressive effects. Licorice is used as an envoy to harmonize the various drugs.

[0023] Based on the above mechanism, the product of this application can also be used to treat purpura, infantile eczema, skin impetigo, oral ulcers, hypertrophy of adenoids in children, etc.

[0024] Compared with the prior art, the embodiments of the present application have at least the following advantages or beneficial effects:

[0025] In theory, this application adopts Atractylodes lancea, Phellodendron chinense, and Lonicera japonica as the main medicines, Coix seed, Rhizoma Achyranthis Bidentatae, and Sophora flavescens as the auxiliary medicines, and Dictamni cortex, Kochia scoparia, Periostracum cicadae, and Licorice as the adjuvant medicines, combining traditional Chinese medicine and modern pharmacological effects to achieve the effects of clearing away heat and dampness, invigorating the spleen and draining dampness, and dispelling wind and relieving itching; in actual application, it has a significant improvement and cure effect on the symptoms of atopic dermatitis in children, and has a fast onset of action, short efficacy, low side effects, and no recurrence after recovery, bringing a good experience to such patients in clinical practice. DETAILED DESCRIPTION

[0026] In order to make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be described clearly and completely below. If the specific conditions are not specified in the embodiments, they are carried out according to the conventional conditions or the conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be purchased commercially.

[0027] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. The present application will be described in detail below with reference to specific embodiments.

[0028] A traditional Chinese medicine composition for treating atopic dermatitis in children comprises the following Chinese medicinal materials in parts by weight: 4-8 parts of atractylodes, 6-10 parts of honeysuckle, 4-8 parts of phellodendron, 4-8 parts of coix seeds, 4-8 parts of achyranthes, 2-8 parts of sophora flavescens, 4-8 parts of difficile cortex, 4-8 parts of kochia scoparia, 2-8 parts of cicada molt and 2-8 parts of liquorice.

[0029] In some embodiments of the present application, the above-mentioned Chinese medicine composition includes the following components of Chinese medicinal materials: 6 parts of Atractylodes lancea, 8 parts of Honeysuckle, 6 parts of Phellodendron chinense, 6 parts of Coix seeds, 6 parts of Achyranthes bidentata, 5 parts of Sophora flavescens, 6 parts of Dictamni cortex, 6 parts of Kochia scoparia, 5 parts of Periostracum cicadae and 5 parts of Licorice.

[0030] In some embodiments of the present application, the above-mentioned Achyranthes bidentata is Achyranthes bidentata.

[0031] A method for preparing a Chinese medicine composition for treating atopic dermatitis in children comprises the following steps:

[0032] S1, soaking the Chinese medicinal materials in water, then heating and refluxing for extraction, filtering, and taking the filtrate;

[0033] S2. Concentrate the filtrate into a clear paste, add ethanol after cooling, let it stand, take the supernatant and recover the ethanol, then concentrate it twice to obtain a Chinese medicine paste, granulate the Chinese medicine paste to obtain the Chinese medicine composition product for treating pediatric atopic dermatitis.

[0034] In some embodiments of the present application, the ratio of medicinal materials to water added in the above-mentioned step S1 is 1: (6-14), the soaking temperature is room temperature, and the soaking time is 0.5-3h; the number of heating reflux extractions is twice, each time for 1-3h, and the filtrates from the two times are combined and then concentrated in step S2.

[0035] In some embodiments of the present application, the concentration in the above-mentioned S2 step adopts reduced pressure concentration, the vacuum degree of concentration is -0.09MPa~-0.04Mpa, the concentration temperature is 60~80°C, and the relative density of the clear paste after concentration is 1.10~1.25.

[0036] In some embodiments of the present application, the alcohol content after adding ethanol in the above step S2 is 30-80%, and the standing time is 8-48 hours.

[0037] In some embodiments of the present application, the secondary concentration in the above-mentioned S2 step adopts vacuum concentration, and the concentrated Chinese medicine ointment is a thick paste with a relative density of 1.25 to 1.36. Auxiliary materials are added to the thick paste, mixed and granulated, and the Chinese medicine composition product is obtained after drying.

[0038] In some embodiments of the present application, the auxiliary materials include sweeteners, flavoring agents and / or bitterness inhibitors.

[0039] Sweeteners include glucose, fructose, sucrose, starch syrup, xylitol, monosyrup, fruit juice syrup, honey, stevioside, sorbitol, mannitol, D-tagatose, stevioside, aspartame, saccharin, cyclamate, aspartame, acesulfame potassium, alitame, neotame, sucralose, isomalt, and new sugars (fructose oligosaccharides).

[0040] Fragrances include peppermint oil, cinnamon oil, anise oil, peppermint water, compound cardamom anhydride, banana flavor, pineapple flavor, orange flavor, lemon flavor, chocolate flavor, glucose flavor, red apple flavor, strawberry flavor, and peach flavor.

[0041] Bitterness inhibitors include caffeic acid, ferulic acid, citric acid, adenosine monophosphate, phosphatidic acid, protein-phosphatidic acid complex, tannic acid, and neomycin.

[0042] In some embodiments of the present application, the secondary concentration in the above-mentioned S2 step adopts reduced pressure concentration, and the concentrated Chinese medicine paste is a clear paste with a relative density of 1.05 to 1.25. The clear paste is granulated in one step and dried to obtain a Chinese medicine composition product.

[0043] The features and performance of the present application are further described in detail below in conjunction with the embodiments.

[0044] Example 1

[0045] This embodiment provides a Chinese medicine composition for treating atopic dermatitis in children, and the preparation method thereof is as follows:

[0046] S1. Weigh the Chinese medicinal materials: 6g of Atractylodes lancea, 8g of Honeysuckle, 6g of Phellodendron chinense, 6g of Coix seeds, 6g of Achyranthes bidentata, 5g of Sophora flavescens, 6g of Dictamni, 6g of Kochia scoparia, 5g of Periostracum cicadae, and 5g of Licorice; add the above raw materials to 10 times the amount of water and soak for 2h, heat and reflux to extract twice, each time for 2h, filter, and combine the filtrates of the two times;

[0047] S2, the filtrate is concentrated under reduced pressure, the temperature of the concentrated under reduced pressure is 75 ° C, the concentration vacuum is -0.06MPa, and it is concentrated to a clear paste with a relative density of 1.15, cooled, ethanol is added to the clear paste to make the alcohol content reach 55%, mixed and allowed to stand for 24h, the supernatant is taken, filtered, the filtrate is recovered ethanol, and then concentrated under reduced pressure to a thick paste with a relative density of 1.28. The temperature during the concentration step is 70 ° C, and the concentration vacuum is -0.06MPa;

[0048] S3. Add common auxiliary sweeteners and aromatics to the thick paste, mix well, make into granules, dry and obtain whole granules.

[0049] Example 2

[0050] This embodiment provides a Chinese medicine composition for treating atopic dermatitis in children, and the preparation method thereof is as follows:

[0051] S1. Weigh the Chinese medicinal materials: 8g of Atractylodes lancea, 6g of Honeysuckle, 6g of Phellodendron chinense, 8g of Coix seeds, 5g of Achyranthes bidentata, 6g of Sophora flavescens, 6g of Dictamni, 6g of Kochia scoparia, 6g of Periostracum cicadae, and 3g of Licorice; add the above raw materials to 12 times the amount of water and soak for 1.5h, heat and reflux to extract twice, each time for 2.5h, filter, and combine the filtrates of the two times;

[0052] S2, the filtrate is concentrated under reduced pressure, the temperature of the concentrated under reduced pressure is 65 ° C, the concentration vacuum is -0.04MPa, and the relative density is 1.15. Clear paste is cooled, ethanol is added to the clear paste to make the alcohol content reach 60%, the mixture is mixed and then allowed to stand for 36h, the supernatant is taken, filtered, the filtrate is recovered with ethanol, and then concentrated under reduced pressure to a thick paste with a relative density of 1.25. The temperature during the concentration step is 70 ° C, and the concentration vacuum is -0.06MPa;

[0053] S3. Add common auxiliary sweeteners and aromatics to the thick paste, mix well, make into granules, dry and obtain whole granules.

[0054] Example 3

[0055] This embodiment provides a Chinese medicine composition for treating atopic dermatitis in children, and the preparation method thereof is as follows:

[0056] S1. Weigh the Chinese medicinal materials: 8g of Atractylodes lancea, 8g of Honeysuckle, 4g of Phellodendron chinense, 4g of Coix seeds, 5g of Achyranthes bidentata, 8g of Sophora flavescens, 4g of Dictamni, 8g of Kochia scoparia, 6g of Periostracum cicadae, and 4g of Licorice; add the above raw materials to 14 times the amount of water and soak for 1.5h, heat and reflux to extract twice, each time for 3h, filter, and combine the filtrates of the two times;

[0057] S2, the filtrate is concentrated under reduced pressure, the temperature of the concentrated under reduced pressure is 65 ° C, the concentration vacuum is -0.04MPa, and it is concentrated to a clear paste with a relative density of 1.10, cooled, ethanol is added to the clear paste to make the alcohol content reach 60%, mixed and allowed to stand for 36h, the supernatant is taken, filtered, the filtrate is recovered ethanol, and then concentrated under reduced pressure to a thick paste with a relative density of 1.35. The temperature during the concentration step is 75 ° C, and the concentration vacuum is -0.06MPa;

[0058] S3. Add common auxiliary bitterness inhibitors and aromatics to the thick paste, mix well, make granules, dry, and obtain whole granules.

[0059] Example 4

[0060] This embodiment provides a Chinese medicine composition for treating atopic dermatitis in children, and the preparation method thereof is as follows:

[0061] S1. Weigh the Chinese medicinal materials: 7g of Atractylodes lancea, 10g of Honeysuckle, 5g of Phellodendron chinense, 8g of Coix seeds, 5g of Achyranthes bidentata, 6g of Sophora flavescens, 4g of Dictamni, 4g of Kochia scoparia, 4g of Periostracum cicadae, and 2g of Licorice; add the above raw materials to 9 times the amount of water and soak for 2h, heat and reflux to extract twice, each time for 3h, filter, and combine the filtrates of the two times;

[0062] S2, the filtrate is concentrated under reduced pressure, the temperature of the concentrated under reduced pressure is 80 ° C, the concentration vacuum is -0.09 MPa, and it is concentrated to a clear paste with a relative density of 1.10, cooled, ethanol is added to the clear paste to make the alcohol content reach 70%, mixed and allowed to stand for 12 hours, the supernatant is taken, filtered, the filtrate recovers ethanol, and then concentrated under reduced pressure to a thick paste with a relative density of 1.32. The temperature during the concentration step is 75 ° C, and the concentration vacuum is -0.08 MPa;

[0063] S3. Add common auxiliary bitterness inhibitors and aromatics to the thick paste, mix well, make granules, dry, and obtain whole granules.

[0064] Example 5

[0065] This embodiment provides a Chinese medicine composition for treating atopic dermatitis in children, and the preparation method thereof is as follows:

[0066] S1, Atractylodes 6g, Honeysuckle 8g, Phellodendron 6g, Coix Seed 6g, Achyranthes bidentata (Huai) 6g, Sophora flavescens 5g, Dictamni 6g, Kochia scoparia 6g, Periostracum cicadae 5g, Licorice 5g; add the above raw materials to 10 times the amount of water and soak for 2h, heat and reflux to extract twice, each time for 2h, filter, and combine the filtrates;

[0067] S2. Concentrate the filtrate under reduced pressure at a temperature of 80°C and a concentration vacuum of -0.09MPa, concentrate to a clear paste with a relative density of 1.12, cool, add ethanol to the clear paste to make the alcohol content reach 80%, mix and let stand for 12 hours, take the supernatant, filter, recover ethanol from the filtrate, and then concentrate under reduced pressure to a clear paste with a relative density of 1.25. The concentration temperature in this step is 75°C and the concentration vacuum is -0.08MPa; directly granulate the clear paste in one step and dry it.

[0068] Example 6

[0069] This embodiment provides a Chinese medicine composition for treating atopic dermatitis in children, and the preparation method thereof is as follows:

[0070] S1, Atractylodes 8g, Honeysuckle 7g, Phellodendron 6g, Coix seeds 5g, Achyranthes bidentata (Huai) 6g, Sophora flavescens 5g, Dictamni 5g, Kochia scoparia 6g, Periostracum cicadae 6g, Licorice 4g; add the above raw materials to 10 times the amount of water and soak for 2h, heat and reflux to extract twice, each time for 2h, filter, and combine the filtrates of the two times;

[0071] S2. Concentrate the filtrate under reduced pressure at a temperature of 70°C and a concentration vacuum of -0.06MPa, and concentrate to a clear paste with a relative density of 1.10. Cool, add ethanol to the clear paste to make the alcohol content reach 90%, mix and let stand for 15 hours, take the supernatant, filter, recover ethanol from the filtrate, and then concentrate under reduced pressure to a clear paste with a relative density of 1.20. The concentration temperature in this step is 70°C and the concentration vacuum is -0.06MPa; directly granulate the clear paste in one step and dry it.

[0072] Example 7

[0073] This embodiment provides a Chinese medicine composition for treating atopic dermatitis in children, and the preparation method thereof is as follows:

[0074] S1, Atractylodes 8g, Honeysuckle 6g, Phellodendron 4g, Coix Seed 8g, Achyranthes bidentata (Huai) 6g, Sophora flavescens 4g, Dictamni 4g, Kochia scoparia 6g, Periostracum cicadae 6g, Licorice 5g; add the above raw materials to 10 times the amount of water and soak for 3h, heat and reflux to extract twice, each time for 1.5h, filter, and combine the filtrates of the two times;

[0075] S2. Concentrate the filtrate under reduced pressure at a temperature of 70°C and a concentration vacuum of -0.07MPa, concentrate to a clear paste with a relative density of 1.10, cool, add ethanol to the clear paste to make the alcohol content reach 90%, mix and let stand for 20 hours, take the supernatant, filter, recover ethanol from the filtrate, and then concentrate under reduced pressure to a clear paste with a relative density of 1.10, the concentration temperature in this step is 70°C and the concentration vacuum is -0.07MPa; directly granulate the clear paste in one step and dry it.

[0076] Experimental Example 1

[0077] This experimental example uses the Chinese medicine composition prepared in Example 1 to explore the effect of the above Chinese medicine composition on DNCB-induced atopic dermatitis.

[0078] 1. Animals and groups: 60 BALB / C mice aged 6 to 8 weeks were adaptively fed for 1 week and 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.

[0079] 2. Modeling and drug administration: After grouping, the back skin of all animals was depilated in an area of ​​2cm*4cm. On the first day of modeling, except for the normal group, 150ul of 1% DNCB was applied to the back of the other groups, and 20ul of 1% DNCB was applied to the back of the right ear for 2 consecutive days. On the 7th, 9th, 11th, and 13th days of modeling, except for the normal group, 100ul of 0.2% DNCB solution was applied to the back of the animals in the other groups, and 10ul of 0.2% DNCB solution was applied to the back of the right ear to stimulate and maintain the symptoms of atopic dermatitis in mice. In the early stage, edema, erythema, and scabs accompanied by scratching appeared on the back skin of mice. In the later stage, dark red spots and scales appeared on the back skin, which was considered a successful modeling. Starting from the 15th day of the experiment, the normal group and the model group were given the solvent, the positive drug group was given 10 mg / kg prednisolone by oral gavage, and the test substance group was given different doses of the test substance (low, medium and high doses were 10 g crude drug / kg, 20 g crude drug / kg, and 40 g crude drug / kg, respectively) for 14 consecutive days. After the end of the drug administration, the mice were euthanized and the samples were collected.

[0080] 3. Detection indicators:

[0081] ① Skin lesion scoring: On the 14th day of administration, the back skin of the mice was observed with the naked eye, and the degree of skin lesions of the mice was scored according to the SCORAD scoring standard. Standard: severe erythema, edema, scaling, and epidermal exfoliation were scored as 3 points; moderate erythema, edema, scaling, and epidermal exfoliation were scored as 2 points; mild erythema, edema, scaling, and epidermal exfoliation were scored as 1 point; normal skin was scored as 0 points.

[0082] ② Scratching frequency detection: Record the number of scratching times of mice on the 14th day of drug administration. Place the mice alone in a quiet environment, and record the number of times the mice scratch their ears, backs, abdomens, etc. within 30 minutes. The rear claw is raised to continuously scratch the ears and abdomen, etc., and the landing or licking of the rear claw is considered as one scratch.

[0083] ③Right ear thickness detection: After the administration, the thickness of the right ear of each mouse was measured using a vernier caliper.

[0084] ④ Spleen index and thymus index detection: After the mice were killed, the spleen and thymus were weighed. Spleen index = spleen weight (mg) / body weight (g) * 10, thymus index = thymus weight (mg) / body weight (g) * 10. ⑤ Skin pathology detection: Take an appropriate amount of skin from the lesion on the back of the mouse, fix it in 4% paraformaldehyde solution for 24 hours, put it in ethanol solution for gradient dehydration for 5 minutes, make it transparent in xylene, embed it in paraffin, and cut it into 4μm slices. Hematoxylin-eosin staining, resin sealing, observe the pathological morphological changes of the slices under a light microscope, and observe the degree of epidermal hyperplasia, inflammation and mast cell infiltration.

[0085] 4. Results:

[0086] ① Compared with the normal group, the model group had obvious erythema, edema, scaling or epidermal exfoliation. Compared with the model group, the skin lesions in the positive drug group and the test substance administration groups improved, with scabs on the skin, no erythema, no bleeding, normal hair growth, and reduced skin lesion scores.

[0087] ② Compared with the normal group, the model group had obvious scratching behavior. Compared with the model group, the scratching times of the positive drug group and the test substance administration groups were significantly reduced.

[0088] ③Compared with the normal group, the thickness of the right ear in the model group increased significantly.Compared with the model group, the thickness of the right ear in the positive drug group and the test substance administration groups decreased significantly, and the edema decreased.

[0089] ④Compared with the normal group, the thymus index and spleen index of the model group were significantly increased. Compared with the model group, the thymus index and spleen index of the positive drug group and the test substance administration groups were reduced. The increase in spleen index may be related to over-activated B lymphocytes.

[0090] ⑤ The skin tissue thickness of mice in the normal group was normal, with clear layers. The structure of hair follicles and sebaceous glands in the dermis was intact, and no obvious edema or inflammatory cell infiltration was observed. The epidermis of mice in the model group was significantly thickened, with fewer sebaceous glands, no neatly arranged hair follicles, necrosis, shedding, ulceration, and defects of epidermal cells, unclear cell gaps and layers, incomplete / excessive keratinization of epidermal cells, poor density, pyknotic nuclei in the stratum corneum, inflammatory cell infiltration in the dermis, and epidermal protrusions extending downward. After drug intervention, the epidermal structure of the mice's skin was intact but the thickness increased, a small amount of eosinophils and lymphocytes infiltration was observed in the dermis, incomplete skin keratinization was improved, residual nuclei were seen in the thickened stratum corneum, the granular layer was not obvious, and the skin showed significant improvement.

[0091] 5. Conclusion: The Chinese medicine composition of the present invention can significantly reduce the number of scratching times of mice with atopic dermatitis, inhibit skin itching, and alleviate erythema, edema and skin inflammation caused by atopic dermatitis, and has a therapeutic effect on atopic dermatitis in mice.

[0092] Experimental Example 2

[0093] The Chinese medicine composition prepared in Example 1 of the present application was used clinically.

[0094] 1. Research subjects

[0095] The Chinese medicine combination was used in clinical observation of 60 cases, including 28 males and 32 females, who were randomly divided into a treatment group of 30 cases and a control group of 30 cases, aged 2 to 18 years, with a course of 2 to 14 years. Among them, 12 cases had a clear history of hereditary allergy.

[0096] 2. Diagnostic basis

[0097] Western medicine diagnostic criteria

[0098] According to the diagnostic criteria for AD in Williams' diagnostic criteria, the main features are as follows: a history of skin itching, plus 3 or more of the following: ① a history of skin involvement on the flexor side, including the cubital fossa, popliteal fossa, anterior ankle, or around the neck; ② visible dermatitis on the flexor side; ③ onset before 2 years of age; ④ a history of asthma or allergic rhinitis; ⑤ a history of dry skin all over the body;

[0099] TCM diagnostic criteria

[0100] Refer to the diagnostic criteria for eczema in the "Standards for Diagnosis and Efficacy of Chinese Medicine Diseases and Syndromes" issued by the State Administration of Traditional Chinese Medicine: It is a type of skin disease caused by intolerance of constitution, rheumatic heat invading the skin, and clinically characterized by symmetrical distribution, polymorphic rash, exudation, severe itching, and repeated attacks.

[0101] 3. Usage and Dosage

[0102] Treatment group: patients weighing more than 50 kg were given the medicine prepared by the Chinese medicine composition of the present invention with warm water; patients weighing 30-50 kg were given 2 / 3 of the prescribed dose; patients weighing less than 30 kg were given 1 / 3 of the prescribed dose.

[0103] Control group: Oral administration of loratadine syrup (Want Pharmaceutical (Hainan) Co., Ltd., batch number H20070001), 5 ml per day for patients weighing ≤20 kg, and 10 ml per day for patients weighing >20 kg.

[0104] 4. Efficacy standards

[0105] Refer to the efficacy standards for eczema in the "Diagnosis and Efficacy Standards for TCM Diseases and Syndromes" issued by the State Administration of Traditional Chinese Medicine:

[0106] (1) Basically cured: All skin lesions disappear, symptoms such as itching disappear, and the efficacy index is 90% to 100%;

[0107] (2) Significantly effective: Most of the skin lesions disappear, pruritus is significantly relieved, and the efficacy index is 70% to 90%;

[0108] (3) Effective: skin lesions partially subsided, pruritus symptoms improved, and the efficacy index was 30% to 70%;

[0109] (4) Ineffective: The skin lesions did not subside significantly, the itching did not decrease or the clinical symptoms worsened, and the efficacy index was less than 30%.

[0110] 5. The treatment effects are shown in Table 1

[0111] Table 1

[0112]

[0113]

[0114] Note: Total effective rate = (basically cured cases + markedly effective cases) / total number of cases × 100%

[0115] 6. Typical Cases

[0116] Case example 1: Xu, male, 12 years old. Chief complaint: scattered maculopapular rashes all over the body for more than half a month. The child had red maculopapular rashes and itching all over the body without obvious cause more than half a month ago. After taking the medicine prepared by the Chinese medicine composition of the present application for 4 courses of treatment, the color of the skin lesions became lighter, itching occurred occasionally, and no new rashes were seen. After taking it for 2 more courses of treatment, the skin lesions all subsided, and the symptoms such as itching disappeared, and the child was cured.

[0117] Case example 2: Ye, male, 4 years old. Chief complaint: maculopapular rash on the skin of the whole body for more than half a year. When he came to the clinic, he found red maculopapular rash on the facial skin, which gradually became herpes, accompanied by itching, erosion, exudation, and scabs after rupture. Red maculopapular rash was scattered on the trunk and limbs, accompanied by obvious itching. Diagnosed with atopic dermatitis. After taking the medicine prepared by the Chinese medicine composition of this application for 8 courses of treatment, the color of the erythema became lighter, the exudation of the skin lesions was significantly reduced, and the itching was alleviated. After taking it for 6 courses of treatment, the spots and rashes disappeared, the scabs fell off, and the patient was cured.

[0118] The embodiments described above are part of the embodiments of the present application, rather than all of the embodiments. The detailed description of the embodiments of the present application is not intended to limit the scope of the present application for protection, but merely represents the selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work belong to the scope of protection of the present application.

Claims

1. A Chinese medicine composition for treating atopic dermatitis in children, characterized in that: The Chinese medicinal materials include the following components, in parts by weight: 4-8 parts of Atractylodes lancea, 6-10 parts of Honeysuckle, 4-8 parts of Phellodendron chinense, 4-8 parts of Coix seeds, 4-8 parts of Achyranthes bidentata, 2-8 parts of Sophora flavescens, 4-8 parts of Dictamni cortex, 4-8 parts of Kochia scoparia, 2-8 parts of Periostracum cicadae and 2-8 parts of Licorice.

2. A Chinese medicine composition for treating atopic dermatitis in children according to claim 1, characterized in that: In parts by weight, the Chinese medicine composition includes the following Chinese medicinal materials: 6 parts of Atractylodes lancea, 8 parts of Honeysuckle, 6 parts of Phellodendron chinense, 6 parts of Coix seeds, 6 parts of Achyranthes bidentata, 5 parts of Sophora flavescens, 6 parts of Dictamni cortex, 6 parts of Kochia scoparia, 5 parts of Periostracum cicadae and 5 parts of Licorice.

3. A Chinese medicine composition for treating atopic dermatitis in children according to claim 1 or 2, characterized in that: The Achyranthes bidentata is Achyranthes bidentata.

4. A method for preparing a Chinese medicine composition for treating atopic dermatitis in children as claimed in any one of claims 1 to 3, characterized in that: The following steps are involved: S1, soaking the Chinese medicinal materials in water, then heating and refluxing for extraction, filtering, and taking the filtrate; S2. Concentrate the filtrate into a clear paste, add ethanol after cooling, let it stand, take the supernatant and recover the ethanol, then concentrate it twice to obtain a Chinese medicine paste, granulate the Chinese medicine paste to obtain the Chinese medicine composition product for treating pediatric atopic dermatitis.

5. The method for preparing a Chinese medicine composition for treating atopic dermatitis in children according to claim 4, characterized in that: In the step S1, the ratio of the medicinal materials to water is 1: (6-14), the soaking temperature is room temperature, and the soaking time is 0.5-3 hours; the heating reflux extraction is performed twice, each time for 1-3 hours, and the filtrates from the two times are combined and then concentrated in step S2.

6. The method for preparing a Chinese medicine composition for treating atopic dermatitis in children according to claim 5, characterized in that: The concentration in step S2 is carried out under reduced pressure, the vacuum degree of the concentration is -0.09MPa to -0.04MPa, the concentration temperature is 60 to 80°C, and the relative density of the concentrated paste is 1.10 to 1.

25.

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

8. The method for preparing a Chinese medicine composition for treating atopic dermatitis in children according to claim 6, characterized in that: In the step S2, the secondary concentration is performed by vacuum concentration. The concentrated Chinese medicine paste is a thick paste with a relative density of 1.25 to 1.

36. Auxiliary materials are added to the thick paste, mixed and granulated, and dried to obtain a Chinese medicine composition product.

9. The method for preparing a Chinese medicine composition for treating atopic dermatitis in children according to claim 8, characterized in that: The auxiliary materials include sweeteners, aromatics and / or bitterness inhibitors.

10. The method for preparing a Chinese medicine composition for treating atopic dermatitis in children according to claim 6, characterized in that: In the step S2, the secondary concentration is performed by vacuum concentration, and the concentrated Chinese medicine paste is a clear paste with a relative density of 1.05 to 1.

25. The clear paste is granulated in one step and dried to obtain a Chinese medicine composition product.

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