Traditional Chinese medicine composition for dermatitis and eczema, and preparation method and application thereof

Abstract

The present invention relates to the field of medical technology, and more particularly to a Chinese medicine composition for dermatitis and eczema, and its preparation method and application. The Chinese medicine composition is prepared by including the following bulk drugs in parts by weight: 5-40 parts of Polygonum cuspidatum, 6-30 parts of Cynanchum chinense, 5-30 parts of Dictamni cortex, 5-30 parts of Smilax glabra, 5-30 parts of Scutellaria baicalensis, 5-30 parts of Fructus Forsythiae, 5-30 parts of Paeonia suffruticosa, and 6-30 parts of Paeonia lactiflora. The Chinese medicine composition provided by the present invention has a unique prescription, and each medicinal flavor is combined to give full play to the prescription drug effect, and can be used for the treatment of acute and chronic nonspecific dermatitis and eczema, with rapid onset and remarkable efficacy. Especially for the therapeutic effect of chronic nonspecific dermatitis and eczema, it is very significant.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a traditional Chinese medicine composition for treating dermatitis and eczema, and a preparation method and application thereof. Background Art

[0002] Eczema (eczema) is an inflammatory skin disease with an exudative tendency caused by a variety of internal and external factors. It is relatively common clinically and can be divided into three categories: acute, subacute and chronic. Acute eczema has a relatively fast onset, and skin lesions often show as dense millet-sized papules, papulovesicles or small blisters on the basis of erythema, often with dotted or small flaky erosive surfaces, with obvious serous exudation, and many have severe itching. Subacute eczema often develops from acute eczema, and skin lesions are dark red, and are mainly composed of small papules, scales and scabs on the basis of erythema, with a small amount of papulovesicles or blisters and erosions, and mild infiltration may be arranged, and itching is mostly more severe. Chronic eczema is often formed by the prolongation of acute and subacute eczema, or the onset is chronic, and it shows as thickening of the skin of the affected part, and infiltration or lichenification may be arranged. Skin lesions are mostly dark red or gray-brown, and are locally dry, rough, and scaly. They may be accompanied by hyperpigmentation or hypopigmentation, and often have obvious itching symptoms. The pathogenesis of eczema is complex, and modern medicine believes it is closely related to genetics, immunity, diet, and environmental exposure. Eczema can occur in people of all ages, genders, and seasons, and is often caused by a congenital intolerance, severely impacting patients' quality of life.

[0003] For this type of disease, Western medicine (such as antihistamines, corticosteroids and immunosuppressants) is often used clinically for treatment. Although antihistamines can relieve itching symptoms with minimal side effects, the recurrence rate after discontinuation of the drug is high. Steroid drugs can improve itching and skin lesions in the short term, with a fast onset, strong effect and significant effect, but long-term use can cause serious adverse reactions and poor therapeutic effects, so they are not suitable for long-term use. Chemical immunosuppressants all have serious adverse reactions and should be used with caution, and only when other therapies are ineffective.

[0004] In recent years, traditional Chinese medicine and its compound preparations have shown certain effects in the treatment of eczema with relatively few side effects. The consensus of experts in the diagnosis and treatment of eczema (wet sores) published in 2021 recommended Chinese patent medicines such as Xiaofeng Zhiyang Granules, Jinchan Zhiyang Capsules, Runzao Zhiyang Capsules, and Tripterygium wilfordii polyglycosides tablets. Among them, the treatment methods are mainly based on clearing heat, dispelling wind, removing dampness, and activating blood circulation. Although they have certain therapeutic effects, they will still recur; in addition, although Tripterygium wilfordii polyglycosides tablets have anti-inflammatory and cellular immunity and humoral immunity inhibitory effects, they are highly toxic and have obvious side effects.

[0005] In view of this, the present invention is proposed. Summary of the Invention

[0006] To solve the above technical problems, the present invention provides a traditional Chinese medicine composition for dermatitis and eczema, its preparation method, and use. The traditional Chinese medicine composition suppresses the immune response to control acute and chronic eczema symptoms, reducing and preventing recurrence, and achieving a therapeutic effect that addresses both the symptoms and the root cause.

[0007] Specifically, the technical solution of the present invention is as follows:

[0008] In a first aspect, the present invention provides a traditional Chinese medicine composition, which is prepared from the following raw materials in parts by weight: 5-40 parts of Polygonum cuspidatum, 6-30 parts of Cynanchum chinense, 5-30 parts of Dictamni cortex, 5-30 parts of Smilax glabra, 5-30 parts of Scutellaria baicalensis, 5-30 parts of Forsythia suspensa, 5-30 parts of Paeonia suffruticosa, and 6-30 parts of Paeonia lactiflora.

[0009] The traditional Chinese medicine composition provided by the invention is a pure traditional Chinese medicine preparation, has the functions of detoxifying, removing dampness, dispelling wind and relieving itching, and can be used for acute and chronic nonspecific dermatitis and eczema.

[0010] Specifically, in the Chinese medicine composition of the present invention, the efficacy and compatibility principles of each raw material are as follows:

[0011] Polygonum cuspidatum clears heat, detoxifies, and disperses blood stasis, and enters the liver, gallbladder, and lung meridians, making it a monarch drug. Dictamnus radix phellodendri clears heat and dries dampness, dispels wind and detoxifies, and enters the spleen, stomach, and bladder meridians. Cynanchum chinense dispels wind, removes dampness, and relieves itching, while Rhizoma Smilacis Glabrae dispels toxins and removes dampness. Together, these three are ministerial drugs, assisting the monarch drug in detoxifying, dispelling wind, removing dampness, and relieving itching. Fructus Forsythiae clears heat and detoxifies, reduces swelling, disperses stagnation, and dispels wind-heat. Radix Scutellariae clears heat, dries dampness, and purges fire. Together, they serve as adjuvant drugs, assisting in the heat-clearing, detoxifying, and dampness-drying effects. Cortex Moutan and Radix Paeoniae Rubra serve as guiding drugs, guiding the other drugs to clear dampness and heat from the body, cool the blood, activate blood circulation, and resolve blood stasis and relieve pain. The combination of these drugs has the effect of activating blood circulation, dispelling dampness, and relieving itching. It is used for red papules with symptoms such as burning skin, severe itching, fever, and thirst, and can treat both the symptoms and the root cause of acute and chronic nonspecific dermatitis and eczema.

[0012] In the Chinese medicine composition described in the present invention, the modern pharmacological effects of each raw material are as follows: Smilax glabra contains brass, phenylpropanoids, steroids, organic acids, volatile oils, etc., and has obvious pharmacological activity in anti-inflammatory, analgesic, and immune system aspects. Paeonol in Paeony Cortex has anti-tumor, antibacterial and anti-inflammatory, and immune regulation functions. The chemical components of Cynanchum chinense include volatile oils, C21 steroids, polysaccharides, flavonoids, etc., and have analgesic, anti-inflammatory, antiviral, antitumor, neuroprotective, and anti-snake venom pharmacological effects. Dictamni contains alkaloids, limonoids, flavonoids, sesquiterpenes and their glycosides, steroids, etc., and has anti-inflammatory, antifungal, insecticidal, anti-atherosclerotic, hemostatic, anticancer, neuroprotective, and antioxidant pharmacological effects. Scutellaria baicalensis has anti-inflammatory, analgesic, antimicrobial, and antioxidant pharmacological effects. The chemical components of Polygonum cuspidatum include quinones, stilbenes, flavonoids, and phenylpropanoids; they can be used to treat inflammation, diabetes, gout, cancer, viral diseases, bacterial infections, and neurodegenerative diseases. Their pharmacological activities include antiviral (anti-coronavirus, anti-HIV, anti-hepatitis virus, anti-enterovirus, etc.), anti-inflammatory, antioxidant, anti-cancer, antibacterial, anti-diabetic, anti-gout, neuroprotective, estrogen-like, and angiogenic effects. The chemical components and pharmacological effects of Forsythia suspensa include lignin, flavonoids, terpenes and volatile oils, phenylethanoid glycosides, phenolic acids, C6-C2 natural alcohols and glycosides, and have anti-tumor, immunomodulatory, antiviral, antioxidant, hepatoprotective, anti-inflammatory, and antibacterial effects. Red peony root includes monoterpene glycosides, triterpenes, flavonoids, tannins, phenolic acids, sugars, steroids and volatile oils; it has a wide range of pharmacological effects, including protecting myocardial cells and nerve cells, stabilizing microcirculation, anti-endotoxin, anti-atherosclerosis, lowering pulmonary hypertension, anti-depression, liver protection, anti-gastric ulcer, anti-tumor, slowing down aging, treating Parkinson's syndrome and diabetes and its complications, anti-radiation, anti-inflammatory, anti-virus, etc.

[0013] The traditional Chinese medicine composition provided by the present invention has an immunosuppressive effect, and achieves the therapeutic effect of controlling and reducing dermatitis and eczema and preventing recurrence by inhibiting the immune response.

[0014] Based on the above treatment principles, in a preferred embodiment of the present invention, the Chinese medicine composition is prepared from the following raw materials in parts by weight: 8-14 parts of Polygonum cuspidatum, 12-14 parts of Cynanchum chinense, 8-14 parts of Dictamni cortex, 8-10 parts of Smilax glabra, 8-10 parts of Scutellaria baicalensis, 8-10 parts of Forsythia suspensa, 8-10 parts of Paeonia suffruticosa, and 12-14 parts of Paeonia lactiflora.

[0015] More preferably, the Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of Polygonum cuspidatum, 12 parts of Cynanchum chinense, 10 parts of Dictamni cortex, 10 parts of Smilax glabra, 10 parts of Scutellaria baicalensis, 10 parts of Forsythia suspensa, 10 parts of Paeonia suffruticosa, and 12 parts of Paeonia lactiflora.

[0016] The present invention does not impose any particular limitation on the sources of the above-mentioned raw materials, and any raw material from conventional commercial sources in the field can be used.

[0017] Compared to traditional Chinese medicine formulas, the Chinese herbal composition provided by the present invention has anti-inflammatory and anti-hypersensitivity properties and is suitable for various types of eczema, especially chronic eczema. The Chinese herbal composition provided by the present invention can reduce the frequency of itching and ear thickness in mice with acute eczema and significantly reduce ear thickness in mice with a chronic eczema model. HE results show that the Chinese herbal composition provided by the present invention can improve pathological changes such as epidermal thickening, dermal edema, and inflammatory infiltration in mice with chronic eczema.

[0018] In a second aspect, the present invention provides a traditional Chinese medicine preparation, which is prepared from the traditional Chinese medicine composition alone, or from the traditional Chinese medicine composition and a pharmaceutically acceptable carrier and / or excipient.

[0019] The present invention does not particularly limit the specific dosage form of the traditional Chinese medicine preparation.

[0020] In a preferred embodiment of the present invention, the dosage form of the traditional Chinese medicine preparation is tablets, pills, capsules, granules, granules or oral liquids.

[0021] In a third aspect, the present invention provides a method for preparing the Chinese medicine preparation, comprising the following steps: weighing each raw material drug by weight, then extracting each raw material drug in an extraction solvent to obtain an extract; combining the extract with the carrier and / or excipient to obtain a Chinese medicine preparation.

[0022] In the specific embodiment provided by the present invention, each medicinal material is preferably processed by the following processing technology before being weighed:

[0023] Japanese knotweed: remove impurities, wash, soak thoroughly, cut into thick slices, and dry.

[0024] Dictamnus peel: remove impurities, wash, moisten slightly, cut into thick slices, and dry

[0025] Xu Changqing: Remove impurities, wash quickly, cut into sections, and dry in the shade.

[0026] Smilax glabra: soak, wash, moisten thoroughly, cut into thin slices, and dry.

[0027] Scutellaria baicalensis: Remove impurities from the Scutellaria baicalensis slices, boil them in boiling water for 10 minutes, take them out, simmer them thoroughly, cut them into thin slices, and dry them; or steam them for half an hour, take them out, cut them into thin slices, and dry them.

[0028] Forsythia: Harvest the fruits in autumn when they are just beginning to ripen and are still green, remove impurities, steam them, and dry them in the sun; or harvest the fruits when they are fully ripe, dry them in the sun, and remove impurities.

[0029] Peony bark: Wash quickly, moisten, cut into thin slices, and dry in the sun.

[0030] Red peony root: remove impurities, separate into large and small sizes, wash, soak thoroughly, cut into thick slices, and dry.

[0031] Preferably, the extraction solvent is water.

[0032] Preferably, the extraction method comprises: placing each raw material drug in 6-10 times the amount of water and decocting for 30-90 minutes, filtering, adding 4-8 times the amount of water to the filter residue, decocting for 20-60 minutes, filtering, and combining the drug solutions.

[0033] More preferably, the extraction method is: placing each raw material drug in 8 times the amount of water and boiling for 40 minutes, filtering, adding 6 times the amount of water to the filter residue, boiling for 30 minutes, filtering, and combining the drug solutions.

[0034] In a specific embodiment provided by the present invention, the extract is preferably concentrated and dried, and then combined with the carrier and / or excipient to obtain a traditional Chinese medicine preparation.

[0035] The preparation method provided by the present invention has a simple process, and the traditional Chinese medicine composition prepared by the preparation method has a longer shelf life and more stable quality.

[0036] In a fourth aspect, the present invention provides the use of the Chinese medicine composition, or the Chinese medicine preparation, or the Chinese medicine preparation prepared by the preparation method in the preparation of drugs for treating dermatitis and eczema.

[0037] Preferably, the dermatitis and eczema is acute or chronic nonspecific dermatitis and eczema.

[0038] Beneficial effects:

[0039] The present invention combines modern Chinese medicine innovation theory, observes and analyzes its pathological change characteristics through a large number of clinical cases, and proposes a Chinese medicine composition for the treatment of dermatitis and eczema, and the Chinese medicine composition is made by including the following bulk drugs in parts by weight: 5-30 parts of Polygonum cuspidatum, 6-30 parts of Cynanchum chinense, 5-30 parts of Dictamni, 5-30 parts of Smilax glabra, 5-30 parts of Scutellaria baicalensis, 5-30 parts of Forsythia suspensa, 5-30 parts of Paeonia suffruticosa, 6-30 parts of Red Peony Root. The Chinese medicine composition provided by the present invention has unique prescription, and each medicinal flavor is combined to give full play to the prescription drug effect, and can be used for the treatment of acute and chronic nonspecific dermatitis and eczema, and is rapid in onset and has remarkable efficacy. Especially the therapeutic effect to chronic nonspecific dermatitis and eczema is very remarkable.

[0040] The present invention provides a refined Chinese medicine composition which can be prepared into various pharmaceutically acceptable dosage forms, is convenient for clinical use, has a large drug loading capacity, is easy to store and carry, has low cost, and is easily accepted by patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] In order to more clearly illustrate the technical solutions of the present invention or the prior art, the drawings required for use in the embodiments or the description of the prior art will be described below.

[0042] Figure 1 This is the result of Experimental Example 1 of the present invention on the frequency of itching in mice with acute eczema.

[0043] Figure 2 This is the result of Experimental Example 1 of the present invention on the ear weight of mice with acute eczema.

[0044] Figure 3 This is the result of Experimental Example 2 of the present invention on the frequency of itching in mice with chronic eczema.

[0045] Figure 4 These are the results of Experimental Example 2 of the present invention on the ear weight and ear thickness of mice with chronic eczema.

[0046] Figure 5 This is the result of Experimental Example 2 of the present invention on the ear tissue pathology of mice with chronic eczema.

[0047] Figure 6 These are the results of Experimental Example 2 of the present invention on the effects of serum IL-1β and IgE in mice with chronic eczema. DETAILED DESCRIPTION

[0048] The following examples provide a detailed description of the technical solutions provided by the present invention, but they should not be construed as limiting the scope of protection of the present invention. Unless otherwise specified, the experimental methods used in the examples are conventional methods; the materials and reagents used are all commercially available.

[0049] Example 1

[0050] This embodiment provides a traditional Chinese medicine composition, which has a formula by weight:

[0051] 10 parts of Polygonum cuspidatum, 12 parts of Radix Cynanchifoliae, 10 parts of Cortex Dictamni, 10 parts of Rhizoma Smilacis Glabrae, 10 parts of Radix Scutellariae, 10 parts of Fructus Forsythiae, 10 parts of Cortex Moutan, 12 parts of Radix Paeoniae Rubra.

[0052] This embodiment also provides a Chinese medicine (granule) preparation comprising the above-mentioned Chinese medicine composition, and its preparation method is as follows:

[0053] Weigh the processed raw materials according to the prescribed dosage, then add 8 times the amount of water to each raw material, decoct for 40 minutes, filter, add 6 times the amount of water to the filter residue, decoct for 30 minutes, filter, combine the liquid medicines, and concentrate to a concentrated paste with a density of 1.2±0.05 (60°C). Dry under reduced pressure at 70°C to obtain a dry paste. Crush the dry paste through a 60-mesh sieve to obtain an extract powder, add 12 parts of dextrin, mix well, granulate with 70% ethanol, and dry to obtain the product.

[0054] Example 2

[0055] This embodiment provides a traditional Chinese medicine composition, which has a formula by weight:

[0056] 8 parts of Polygonum cuspidatum, 14g of Cynanchum chinense, 8 parts of Dictamni Cortex, 8 parts of Rhizoma Smilacis Glabrae, 8 parts of Radix Scutellariae, 8 parts of Fructus Forsythiae, 8 parts of Cortex Moutan, 14 parts of Radix Paeoniae Rubra.

[0057] This embodiment also provides a Chinese medicine (granule) preparation comprising the above-mentioned Chinese medicine composition, and its preparation method is the same as that of Example 1.

[0058] Example 3

[0059] This embodiment provides a traditional Chinese medicine composition, which has a formula by weight:

[0060] 14 parts of Polygonum cuspidatum, 14g of Cynanchum chinense, 14 parts of Dictamni Cortex, 10 parts of Rhizoma Smilacis Glabrae, 10 parts of Radix Scutellariae, 10 parts of Fructus Forsythiae, 10 parts of Cortex Moutan, 12 parts of Radix Paeoniae Rubra.

[0061] This embodiment also provides a Chinese medicine (granule) preparation comprising the above-mentioned Chinese medicine composition, and its preparation method is the same as that of Example 1.

[0062] Comparative Example 1

[0063] Compared with Example 1, the only difference is that the formula of the Chinese medicine composition does not contain Polygonum cuspidatum. The specific formula is:

[0064] 12 parts of Radix Cynanchifoliae, 10 parts of Cortex Dictamni, 10 parts of Rhizoma Smilacis Glabrae, 10 parts of Radix Scutellariae, 10 parts of Fructus Forsythiae, 10 parts of Cortex Moutan, 12 parts of Radix Paeoniae Rubra.

[0065] Comparative Example 2

[0066] Compared with Example 1, the only difference is that the formula of the Chinese medicine composition does not contain Cynanchum chinense, and its specific formula is: 10 parts of Polygonum cuspidatum, 10 parts of Dictamni cortex, 10 parts of Smilax glabra, 10 parts of Scutellaria baicalensis, 10 parts of Forsythia suspensa, 10 parts of Paeonia suffruticosa, and 12 parts of Paeonia lactiflora.

[0067] Comparative Example 3

[0068] Antihistamine: Loratadine (approval number: National Medicine Standard H10970410, Bayer Pharmaceuticals Shanghai Co., Ltd.).

[0069] Comparative Example 4

[0070] Chinese patent medicine: Xiaofeng Zhiyang Granules (approval number: National Medicine Standard Z22025024, Jilin Zixin Pharmaceutical Co., Ltd.).

[0071] Experimental Example 1

[0072] Comparison of drug efficacy trials for acute eczema

[0073] In this experimental example, the concentrated ointment with a density of 1.2 prepared in Example 1, Comparative Example 1 and Comparative Example 2 was diluted 10 times with water and compared with the acute eczema efficacy test at the same dosage; and compared with the antihistamine loratadine.

[0074] Modeling and Dosing: Sixty ICR mice were randomly divided into six groups of 10 mice each: control group, model group, Example 1 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group. One day before the experiment, a 2 cm x 2 cm area on the back of the mice was depilated. On the day of the experiment, all mice (except the control group) were sensitized with 100 μl of 7% DNCB solution (acetone:soybean oil = 4:1) applied to the depilated area. Five days later, the mice were challenged with 10 μl of 1% DNCB solution (acetone:soybean oil = 4:1) applied to the inside of the right ear. The left ear was challenged with an equal amount of substrate solution. The control group received an equal amount of substrate solution applied to both ears. After challenge, visible redness and swelling of the right ear was observed. Twenty-four hours after sensitization, each group began receiving the prescribed dose of 0.2 ml of the drug by gavage once daily for seven consecutive days.

[0075] The results of the effect on the number of itching times in mice with acute eczema are shown in Figure 1 . Figure 1 The results showed that compared with the control group, the number of pruritus in the model group mice increased significantly (P < 0.01); compared with the model group, the number of pruritus in the Example 1 group and the Comparative Example 2 group mice decreased significantly (P < 0.05 or P < 0.01); the number of pruritus in the Comparative Example 3 group mice also decreased significantly (P < 0.01) ( Figure 1 ); Comparative Example 1 group, no significant change. This shows that Example 1 group, Comparative Example 2 group and Comparative Example 3 group are better than Comparative Example 1 group.

[0076] The results of the effect on ear weight of mice with acute eczema are shown in Figure 2 . Figure 2 The results showed that compared with the control group, the ear weight of the mice in the model group increased significantly (P<0.01); compared with the model group, the ear weight of the mice in Example 1 and Comparative Example 2 groups increased significantly (P<0.05 or P<0.01, Figure 2 ), the ear weight of mice in the comparative example 3 group showed a downward trend compared with the model group, but there was no statistical difference. This shows that the example 1 group and the comparative example 2 group were better than the comparative example 1 group and the comparative example 3 group.

[0077] The results of Experimental Example 1 show that compared with Comparative Examples 1-3, the Chinese medicine composition provided in Example 1 of the present application has better efficacy on acute eczema.

[0078] Experimental Example 2

[0079] Comparison of drug efficacy trials for chronic eczema

[0080] In this experimental example, the concentrated ointment with a density of 1.2 prepared in Example 1, Comparative Example 1 and Comparative Example 2 was diluted 10 times with water and compared with the same dosage in a chronic eczema efficacy test; and compared with the antihistamine loratadine.

[0081] Modeling and Dosing: 60 mice were randomly divided into 6 groups, each with 10 mice: control group, model group, Example 1 group, Comparative Example 1 group, Comparative Example 2 group, and Comparative Example 3 group. One day before the experiment, a 2 cm x 2 cm area was removed from the back of the mice for hair removal. On the day of the experiment, all mice (except the control group) were sensitized with 100 μl of 7% DNCB solution (acetone:soybean oil = 4:1) applied to the hairless area. Five days later, the mice were challenged for the first time by applying 10 μl of 1% DNCB solution (acetone:soybean oil = 4:1) to the inside of the right ear. The left ear was treated with an equal amount of the substrate solution. The control group received an equal amount of the substrate solution on both ears. The mice were challenged once every three days for a total of four times. Twenty-four hours after sensitization, each group began receiving the prescribed dose of 0.2 ml of the drug by gavage once daily for 19 consecutive days.

[0082] The results of the effect on the frequency of itching in mice with chronic eczema are shown in Figure 3 . Figure 3 The results showed that compared with the control group, the number of pruritus in the model group mice increased significantly (P<0.01); compared with the model group, both the embodiment and the comparative example could significantly reduce the number of pruritus in the chronic eczema mice (P<0.05 or P<0.01); the number of pruritus in the comparative example 3 (loratadine group) mice decreased significantly (P<0.01, Figure 3 ), indicating that each formula can improve the itching condition of chronic eczema mice. The examples and comparative examples can play a corresponding role.

[0083] The results of the effect on ear weight and ear thickness of chronic eczema mice are shown in Figure 4 . Figure 4 The results showed that compared with the control group, the ear weight and ear thickness of the mice in the model group increased significantly (P < 0.01); compared with the mice in the model group, each formula could reduce the ear weight and ear thickness of the mice, among which the Example 1 group significantly inhibited the increase of the ear weight and ear thickness of the mice (P < 0.05 or P < 0.01); the ear weight and ear thickness of the mice in the Comparative Example 3 (loratadine) group also decreased significantly (P < 0.05 or P < 0.01, Figure 4 ). It shows that both the embodiment and the comparative example can play corresponding roles.

[0084] The results of the effect on ear histopathology of mice with chronic eczema are shown in Figure 5 HE staining results are as follows Figure 5As shown in Figure A, the epidermis and dermis of the ear tissue of the control group mice were intact without epidermal thickening and inflammatory infiltration. The epidermis of the model group mice was moderately hyperkeratotic, with thickening of the granular layer and the acanthus layer and mild spongioedema, and the dermis was structurally disordered with inflammatory cell infiltration. The Example 1 group and the Comparative Example 2 group were able to reduce the symptoms of epidermal hyperkeratosis or parakeratosis, thickening of the granular layer and the acanthus layer, dermal edema and inflammatory cell infiltration in the mice. There was no statistical difference in Comparative Example 1. The ear thickness results under the microscope are shown in Figure 1. Figure 5 As shown in Figure B, compared with the control group, the ear thickness of the model group mice increased significantly (P < 0.01); compared with the model group, the Example 1 group was able to significantly inhibit the increase in ear thickness of the chronic eczema mice (P < 0.01); the ear thickness of the loratadine group mice also decreased significantly (P < 0.01); there was no statistical difference between the comparative examples 1 and 2. Pathological scores are as follows Figure 5 As shown in Figure C, compared with the control group, the ear tissue pathology score of the mice in the model group was significantly increased (P < 0.05); compared with the model group, the ear tissue pathology score of the mice in Example 1 and Comparative Example 2 was reduced (P < 0.05), indicating that the Chinese medicine compositions provided in Example 1 and Comparative Example 2 can improve the pathological changes in the chronic eczema model mice. In terms of pathological changes, both Example 1 and Comparative Example 2 groups had a good effect, while the effect of Comparative Example 1 was not obvious, indicating that Polygonum cuspidatum plays a key role in the formula.

[0085] The results of the effects of serum IL-1β and IgE in chronic eczema mice are shown in Figure 6 . Figure 6 The results showed that compared with the control group, the IL-1β and IgE levels in the serum of the model group mice were significantly increased (P<0.05 or P<0.01); compared with the model group, each formula could reduce the serum IL-1β and IgE levels of the chronic eczema mice, among which the Chinese medicine composition provided in Example 1 could significantly inhibit the increase of IL-1β and IgE in the serum of mice (P<0.05 or P<0.01); Comparative Example 1 and Comparative Example 2 could significantly reduce the IL-1β content in the serum of mice (P<0.05), but there was no statistical difference in the change of serum IgE content. Comparative Example 3 (loratadine group) mice could significantly reduce the serum IgE content (P<0.01, Figure 6 ), but there was no statistical difference in IL-1β content ( Figure 6 ). This shows that in terms of immune effect, the effect of Example 1 group is the best.

[0086] Experimental Example 3

[0087] This experimental example uses the Chinese medicine composition prepared in Example 1 for patients with acute eczema, and also provides the following typical cases:

[0088] In October 2020, Mr. Liu, a 38-year-old male, developed papules and small blisters on his skin, accompanied by significant serous exudation and severe itching. He took Xiaofeng Zhiyang Granules on his own, which provided some relief. The condition recurred in December of the same year, and he took Xiaofeng Zhiyang Granules again, but there was no improvement. He subsequently sought treatment at a traditional Chinese medicine hospital, where his temperature was 36.4°C, his pulse 86 beats / minute, his respiratory rate 18 breaths / minute, and his blood pressure 128 / 90 mmHg.

[0089] Diagnosis: Chronic eczema (Western medicine); Wind-heat accumulation in the skin (Traditional Chinese medicine)

[0090] Treatment principle: Activate blood circulation, remove dampness, dispel wind and relieve itching

[0091] Prescription: Polygonum cuspidatum 10g, Cynanchum chinense 12g, Dictamni root bark 10g, Smilax glabra 10g, Scutellaria baicalensis 10g, Forsythia suspensa 10g, Paeonia suffruticosa 10g, Paeonia lactiflora 12g. Decoction twice, extract 300ml of the juice, and take 150ml each morning and evening, warm, for a total of 7 doses. Instruct the patient to discontinue other medications.

[0092] Second visit: No adverse reactions to the medicine, the itching of the skin has been alleviated, and the papules and small blisters have disappeared. The medicine has worked, and the patient is taking another 7 doses of the same prescription.

[0093] Third visit: After taking 14 doses, the skin itching disappeared and the skin appearance returned to normal. An additional 7 doses were taken.

[0094] Four examinations: The patient complained of no adverse reactions after taking the medicine.

[0095] Fifth diagnosis: Symptoms completely disappeared, the patient can live and work normally, clinically cured, and there has been no recurrence in the past two years.

[0096] The above-described embodiments merely illustrate several implementation methods of the present invention, and are provided to facilitate a specific and detailed understanding of the technical solutions of the present invention. They should not be construed as limiting the scope of the invention patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the scope of the present invention, and all such variations and improvements fall within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating dermatitis and eczema, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5-40 parts of polygonum cuspidatum, 6-30 parts of cynanchum chinense, 5-30 parts of white peony root bark, 5-30 parts of smilax glabra, 5-30 parts of scutellaria baicalensis, 5-30 parts of forsythia suspensa, 5-30 parts of moutan bark and 6-30 parts of red peony root.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 8-14 parts of polygonum cuspidatum, 12-14 parts of cynanchum chinense, 8-14 parts of white peony root bark, 8-10 parts of smilax glabra, 8-10 parts of scutellaria baicalensis, 8-10 parts of forsythia suspensa, 8-10 parts of moutan bark and 12-14 parts of red peony root.

3. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of polygonum cuspidatum, 12 parts of cynanchum chinense, 10 parts of white peony root bark, 10 parts of rhizoma smilax, 10 parts of scutellaria baicalensis, 10 parts of forsythia suspensa, 10 parts of moutan bark and 12 parts of red peony root.

4. A Chinese medicine preparation for treating dermatitis and eczema, characterized in that: The invention is prepared from the Chinese medicine composition according to any one of claims 1 to 3 alone, or from the Chinese medicine composition according to any one of claims 1 to 3 and a pharmaceutically acceptable carrier and / or excipient.

5. The Chinese medicine preparation according to claim 4, characterized in that The dosage form of the traditional Chinese medicine preparation is tablets, pills, capsules, granules or oral liquid.

6. The method for preparing the Chinese medicine preparation according to claim 4 or 5, characterized in that: The method comprises the following steps: weighing each raw material medicine by weight, then extracting each raw material medicine in an extraction solvent to obtain an extract; and combining the extract with the carrier and / or excipient to obtain a traditional Chinese medicine preparation.

7. The preparation method according to claim 6, characterized in that: The extraction solvent is water.

8. The preparation method according to claim 7, characterized in that: The extraction method comprises: placing each raw medicine in 6-10 times the amount of water, decocting for 30-90 minutes, filtering, adding 4-8 times the amount of water to the filter residue, decocting for 20-60 minutes, filtering, and combining the medicinal solutions.

9. Use of the Chinese medicine composition according to any one of claims 1 to 3, or the Chinese medicine preparation according to claim 4 or 5, or the Chinese medicine preparation prepared by the preparation method according to any one of claims 6 to 8 in the preparation of a medicament for treating dermatitis and eczema.

10. The use according to claim 9, characterized in that: The dermatitis and eczema is acute or chronic nonspecific dermatitis and eczema.

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