Traditional Chinese medicine composition for treating atopic dermatitis, traditional Chinese medicine preparation for treating atopic dermatitis as well as preparation method and application of traditional Chinese medicine preparation

Abstract

The invention relates to the technical field of traditional Chinese medicines, and discloses a traditional Chinese medicine composition for treating atopic dermatitis. The traditional Chinese medicine composition contains cynanchum paniculatum, tripterygium wilfordii, bletilla striata, cuttlebone, duckweed, mint, radix sophorae flavescentis, golden cypress, moutan bark and liquorice. In addition, the invention further provides a traditional Chinese medicine preparation for treating atopic dermatitis and a preparation method and application of the traditional Chinese medicine preparation. The traditional Chinese medicine composition has the effects of dispelling wind, relieving itching, astringing to stop bleeding, clearing heat, drying dampness, detoxifying and dredging collaterals, and has no toxic or side effect.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, and specifically, to a traditional Chinese medicine composition for treating atopic dermatitis. In addition, the present invention also provides a traditional Chinese medicine preparation for treating atopic dermatitis, a preparation method thereof, and an application thereof. Background Art

[0002] Atopic dermatitis (AD) is a chronic, recurrent, and refractory skin disease with a genetic predisposition, characterized by severe skin itching and eczematous changes, and can develop into other systemic and allergic diseases. Epidemiological surveys show that the global prevalence of AD has been increasing year by year, and 20% of AD patients are affected throughout their lives. Studies show that the overall prevalence of AD in China has been on the rise year by year.

[0003] Atopic dermatitis is characterized by obvious "atopic" characteristics in the patient or their family: ① a familial tendency to easily suffer from asthma, allergic rhinitis, and eczema; ② allergy to foreign proteins; ③ high levels of immunoglobulins in the serum; ④ increased blood eosinophils. Typical atopic dermatitis has specific eczema clinical manifestations and the above four characteristics. Atopic dermatitis is also known as atopic eczema, atopic dermatitis, constitutional prurigo, or genetic allergic eczema, and is clinically divided into three stages: the infantile stage presents as acute or subacute eczema; the childhood and adolescent stages are subacute or chronic eczema; the elderly stage is mainly characterized by lichenification. The disease has a lingering course and is difficult to cure. Due to the long-term and repeated effects of itching, skin rashes, damage to appearance, and drug side effects, it seriously damages the growth and development, physical and mental health of children, affects the quality of work and life in adulthood and old age, and brings a heavy burden to the daily life and society of patients.

[0004] Atopic dermatitis is a chronic and recurrent disease, and clinical symptoms can be relieved or eliminated, recurrence can be reduced and prevented, and the quality of life of patients can be improved through methods such as basic treatment, topical drug treatment, physical treatment, and systemic drug treatment.

[0005] 1. Basic treatment: Breastfeeding is advocated; clothes should be made of cotton, loose, and cool. Pay attention to avoiding various suspected pathogenic factors. During the onset period, spicy foods and alcohol should be avoided, and excessive washing and ironing should be avoided. After bathing, emollients should be used to restore the skin barrier function.

[0006] 2. Topical drug treatment: Select drugs according to the disease severity and age. Topical glucocorticoids are the first-line drugs for the treatment of atopic dermatitis. Weak-potency glucocorticoids are recommended for mild skin lesions; mid-potency glucocorticoids are recommended for moderate skin lesions; high-potency glucocorticoids are recommended for severe hypertrophic skin lesions; weak-potency or mid-potency glucocorticoids are generally selected for skin lesions on the face and skin folds. In addition, calcineurin inhibitors, such as tacrolimus ointment and pimecrolimus cream, also have good curative effects, and wet dressings have a certain therapeutic effect on severe, stubborn, and hypertrophic skin lesions.

[0007] 3. Physical therapy: Narrowband ultraviolet B and UVA1 can be used to treat atopic dermatitis.

[0008] 4. Systemic drug treatment: When itching is severe and affects sleep, consider giving antihistamines. Antibiotics are added for patients with secondary bacterial infections. When secondary herpes simplex virus infection occurs, antiviral treatment is selected. For patients who cannot be controlled by topical drugs and physical therapy, immunosuppressants such as glucocorticoids, cyclosporine capsules, azathioprine tablets, and methotrexate tablets can be selected.

[0009] Generally speaking, most modern medical treatments are symptomatic, non-specific anti-inflammatory or immunosuppressive treatments. The main treatment method is local application of corticosteroids combined with emollients, but continuous or long-term use has side effects such as skin atrophy at the drug application site, drug dependence, rebound after drug withdrawal, and osteoporosis.

[0010] Therefore, there is an urgent need for a traditional Chinese medicine composition that has a good therapeutic effect on atopic dermatitis and has no side effects. Summary of the Invention

[0011] The purpose of the present invention is to overcome the problem of many side effects of the traditional Chinese medicine composition applied to the treatment of atopic dermatitis in the prior art, and to provide a traditional Chinese medicine composition for the treatment of atopic dermatitis. The traditional Chinese medicine composition has the effects of dispelling wind and relieving itching, astringing and stopping bleeding, clearing heat and drying dampness, and detoxifying and dredging collaterals, and has no toxic side effects.

[0012] To achieve the above purpose, the first aspect of the present invention provides a traditional Chinese medicine composition for the treatment of atopic dermatitis, and the traditional Chinese medicine composition contains Cynanchum paniculatum, Tripterygium wilfordii, Bletilla striata, Sepia seu cuttlefish bone, Lemna minor, Mentha haplocalyx, Sophora flavescens, Phellodendron amurense, Paeonia suffruticosa and Glycyrrhiza uralensis.

[0013] Preferably, relative to 10 parts by weight of the Cynanchum paniculatum, the content of Tripterygium wilfordii is 7.5 - 13.5 parts by weight, the content of Bletilla striata is 8.5 - 12 parts by weight, the content of Sepia seu Sepiella is 8.5 - 12 parts by weight, the content of Lemna minor is 7.5 - 13.5 parts by weight, the content of Mentha haplocalyx is 4 - 8.5 parts by weight, the content of Sophora flavescens is 7.5 - 13.5 parts by weight, the content of Phellodendron amurense is 7.5 - 13.5 parts by weight, the content of Paeonia suffruticosa is 6 - 9 parts by weight, and the content of Glycyrrhiza uralensis is 4 - 8.5 parts by weight.

[0014] Preferably, relative to 10 parts by weight of the Cynanchum paniculatum, the content of Tripterygium wilfordii is 8 - 11.5 parts by weight, the content of Bletilla striata is 9 - 11 parts by weight, the content of Sepia seu Sepiella is 9 - 11 parts by weight, the content of Lemna minor is 8 - 12.5 parts by weight, the content of Mentha haplocalyx is 5.5 - 7 parts by weight, the content of Sophora flavescens is 8 - 11.5 parts by weight, the content of Phellodendron amurense is 8 - 11.5 parts by weight, the content of Paeonia suffruticosa is 4 - 8.5 parts by weight, and the content of Glycyrrhiza uralensis is 5.5 - 7 parts by weight.

[0015] The second aspect of the present invention provides a preparation method of a traditional Chinese medicine preparation for treating atopic dermatitis, and the method includes: mixing and heating the traditional Chinese medicine raw materials and water, wherein the traditional Chinese medicine raw materials include Cynanchum paniculatum, Tripterygium wilfordii, Bletilla striata, Sepia seu Sepiella, Lemna minor, Mentha haplocalyx, Sophora flavescens, Phellodendron amurense, Paeonia suffruticosa and Glycyrrhiza uralensis.

[0016] Preferably, relative to 10 parts by weight of the Cynanchum paniculatum, the dosage of Tripterygium wilfordii is 7.5 - 13.5 parts by weight, the dosage of Bletilla striata is 8.5 - 12 parts by weight, the dosage of Sepia seu Sepiella is 8.5 - 12 parts by weight, the dosage of Lemna minor is 7.5 - 13.5 parts by weight, the dosage of Mentha haplocalyx is 4 - 8.5 parts by weight, the dosage of Sophora flavescens is 7.5 - 13.5 parts by weight, the dosage of Phellodendron amurense is 7.5 - 13.5 parts by weight, the dosage of Paeonia suffruticosa is 6 - 9 parts by weight, and the dosage of Glycyrrhiza uralensis is 4 - 8.5 parts by weight.

[0017] Preferably, relative to 10 parts by weight of the Cynanchum paniculatum, the dosage of Tripterygium wilfordii is 8 - 11.5 parts by weight, the dosage of Bletilla striata is 9 - 11 parts by weight, the dosage of Sepia seu Sepiella is 9 - 11 parts by weight, the dosage of Lemna minor is 8 - 12.5 parts by weight, the dosage of Mentha haplocalyx is 5.5 - 7 parts by weight, the dosage of Sophora flavescens is 8 - 11.5 parts by weight, the dosage of Phellodendron amurense is 8 - 11.5 parts by weight, the dosage of Paeonia suffruticosa is 4 - 8.5 parts by weight, and the dosage of Glycyrrhiza uralensis is 5.5 - 7 parts by weight.

[0018] Preferably, the method further includes: concentrating the liquid obtained by the mixing and heating to obtain an extract.

[0019] Preferably, the density of the extract is 1.20 - 1.25 g / mL.

[0020] The third aspect of the present invention provides a traditional Chinese medicine preparation for treating atopic dermatitis.

[0021] The fourth aspect of the present invention provides an application of the above-mentioned traditional Chinese medicine composition for treating atopic dermatitis or the traditional Chinese medicine preparation for treating atopic dermatitis in the preparation of a drug for treating atopic dermatitis.

[0022] Preferably, the atopic dermatitis is damp-heat accumulating in the skin type of atopic dermatitis.

[0023] Through the above technical solutions, the beneficial effects of the present invention are as follows: For the traditional Chinese medicine composition provided by the present invention, Cynanchum paniculatum and Tripterygium wilfordii are used as the monarch drugs for expelling wind and dredging collaterals, resolving dampness and relieving itching; Bletilla striata and Sepia seu Sepiella seu Sepiellae are used as the minister drugs for arresting bleeding and astringing dampness and promoting granulation; Lemna minor, Mentha haplocalyx, Sophora flavescens, Phellodendron amurense, and Paeonia suffruticosa are used as the assistant drugs for clearing heat and cooling blood, drying dampness and detoxifying; Glycyrrhiza uralensis is used as the assistant and guiding drug for detoxifying, relieving spasm and harmonizing the properties of the medicine. The compatibility of various drugs plays the functions of expelling wind and relieving itching, arresting bleeding, clearing heat and drying dampness, and detoxifying and dredging collaterals together. The formula is scientific and reasonable. The functions of each raw material medicinal herb are different but complement each other. The formula is excellent. It has a high symptom remission rate, a high cure rate, and a low recurrence rate for atopic dermatitis.

[0024] In addition, for the traditional Chinese medicine composition provided by the present invention, through the mutual cooperation among Cynanchum paniculatum, Tripterygium wilfordii, Bletilla striata, Sepia seu Sepiella seu Sepiellae, Lemna minor, Mentha haplocalyx, Sophora flavescens, Phellodendron amurense, Paeonia suffruticosa, and Glycyrrhiza uralensis, while reducing the skin irritation of the drug, it can effectively promote wound repair and accelerate drug penetration. Using Glycyrrhiza uralensis as the assistant and guiding drug can fully harmonize the properties of the drugs contained in Cynanchum paniculatum, Tripterygium wilfordii, Bletilla striata, Sepia seu Sepiella seu Sepiellae, Lemna minor, Mentha haplocalyx, Sophora flavescens, Phellodendron amurense, Paeonia suffruticosa, etc., thereby effectively improving the drug efficacy and reducing side effects.

[0025] The traditional Chinese medicine composition provided by the present invention has a wide source of raw materials, low cost, no toxic and side effects, is applicable to damp-heat accumulating in the skin type of atopic dermatitis, can greatly reduce the treatment cost, and relieve the family burden of patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 It is the animal model diagrams of the examples and the comparative examples, wherein, (1) is the blank group; (2) is the model group; (3) is Example 1; (4) is Example 2; (5) is Example 3; (6) is Example 4; (7) is Example 5; (8) is Comparative Example 1; (9) is Comparative Example 2; Figure 2 It is the comparison photos of Patient 1 before and after treatment; Figure 3 It is the comparison photos of Patient 2 before and after treatment; Figure 4 These are the comparison photos of Patient Three before and after treatment. Detailed implementation manners

[0027] The endpoints and any values within the ranges disclosed herein are not limited to the exact ranges or values. These ranges or values should be understood to include values close to these ranges or values. For numerical ranges, the endpoint values within each range, between the endpoint values of each range and individual point values, and between individual point values can be combined with each other to obtain one or more new numerical ranges, and these numerical ranges should be regarded as specifically disclosed herein.

[0028] As mentioned above, the first aspect of the present invention provides a traditional Chinese medicine composition for treating atopic dermatitis. The traditional Chinese medicine composition contains Cynanchum paniculatum, Tripterygium wilfordii, Bletilla striata, Sepia seu cuttlefish bone, Lemna minor, Mentha haplocalyx, Sophora flavescens, Phellodendron amurense, Paeonia suffruticosa and Glycyrrhiza uralensis.

[0029] The pharmacological analysis of the selected traditional Chinese medicine raw materials of the present invention is as follows: Cynanchum paniculatum: Warm in nature, pungent in taste, and attributive to the liver and stomach meridians. It has the effects of expelling wind, resolving dampness, relieving pain and itching, and is used for rheumatic arthralgia, stomachache and distension, toothache, lumbago, traumatic injury pain, rubella and eczema.

[0030] Tripterygium wilfordii: Cool in nature, pungent and bitter in taste, and attributive to the heart and liver meridians. It has the effects of expelling wind and dampness, reducing swelling and relieving pain, and killing insects and detoxifying, and is used for stubborn rheumatic arthralgia, sores, leprosy and stubborn tinea.

[0031] Bletilla striata: Slightly cold in nature, bitter, sweet and astringent in taste; attributive to the lung, liver and stomach meridians. It has the effects of astringing to stop bleeding, reducing swelling and promoting granulation, and is used for hemoptysis, hematemesis, traumatic bleeding, sores and toxic swelling, and skin chaps.

[0032] Sepia seu cuttlefish bone: Warm in nature, salty and astringent in taste; attributive to the spleen and kidney meridians. It has the effects of astringing to stop bleeding, astringing sperm and arresting leucorrhea, regulating acidity and relieving pain, and astringing dampness and promoting granulation, and is used for hematemesis and epistaxis, metrorrhagia and metrostaxis, hematochezia, spermatorrhea and spermatorrhea, external treatment of traumatic bleeding, eczema and damp sores.

[0033] Lemna minor: Cold in nature, pungent in taste; attributive to the lung meridian. It has the effects of diffusing wind-heat, promoting eruption and inducing diuresis, and is used for measles not erupting, rubella itching, and oliguria due to edema.

[0034] Mentha haplocalyx: Cool in nature, pungent in taste; attributive to the lung and liver meridians. It has the functions of dispersing wind-heat, clearing the head and eyes, relieving sore throat, promoting eruption, and soothing the liver and regulating qi, and is used for treating wind-heat cold, initial stage of wind-warm disease, headache, red eyes, sore throat, mouth ulcers, rubella, measles, chest and hypochondrium distension and stuffiness and other diseases.

[0035] Sophora flavescens: Cold in nature, bitter in taste, and attributive to the heart, liver, stomach, large intestine and bladder meridians. It has the effects of clearing away heat and drying dampness, killing insects and inducing diuresis, and is used for treating dysentery with heat, hematochezia, jaundice with oliguria, leukorrhea with red and white discharge, swelling and itching of the vulva, eczema, damp sores, skin itching, scabies and leprosy.

[0036] Phellodendron amurense Rupr.: Cold in nature, bitter in taste, attributing to the kidney meridian and bladder meridian. It has the effects of clearing away heat and dampness, purging fire and removing steaming, detoxifying and treating sores, and is used for treating damp-heat diarrhea, jaundice, leukorrhea, heat strangury, steaming bone fever, night sweats, spermatorrhea; sores and ulcers, eczema and pruritus.

[0037] Moutan Cortex: Bitter and pungent in taste, slightly cold in nature; attributing to the heart, liver and kidney meridians. It has the effects of clearing heat and cooling blood, promoting blood circulation to remove stasis, and is used for treating epidemic febrile disease with maculae, hematemesis and epistaxis, feverish sensation at night and coolness in the early morning, bone steaming without sweating, amenorrhea and dysmenorrhea, carbuncles and sores, traumatic injuries.

[0038] Licorice Root: Neutral in nature, sweet in taste; attributing to the heart, lung, spleen and stomach meridians. It has the effects of replenishing qi and tonifying the middle, relieving spasm and pain, moistening the lungs and relieving cough, purging fire and detoxifying, coordinating various herbs, and is used for treating lassitude and anorexia, emaciation and sallow complexion, palpitation and shortness of breath, abdominal pain and loose stools, spasmodic pain of the limbs, hysteria, cough and asthma, swelling and pain of the throat, sores and ulcers, fetal toxicity and drug and food poisoning.

[0039] The traditional Chinese medicine components used in the present invention can all be obtained through commercial purchase.

[0040] The traditional Chinese medicine composition of the present invention has a unique and reasonable compatibility, and together exerts the functions of dispelling wind and relieving itching, astringing bleeding, clearing away heat and dampness, detoxifying and dredging collaterals. The formula is scientific and reasonable. The functions of each raw material medicinal herb are different but complementary to each other. The formula is excellent. It has a high symptom remission rate, high cure rate and low recurrence rate for atopic dermatitis. Moreover, the traditional Chinese medicine composition provided by the present invention, through the mutual cooperation of Cynanchum paniculatum (Bunge) Kitagawa, Tripterygium wilfordii Hook. f., Bletilla striata (Thunb.) Reichb. f., Sepia seu Endoconcha Sepiae, Lemna minor L., Mentha haplocalyx Briq., Sophora flavescens Ait., Phellodendron amurense Rupr., Moutan Cortex and Licorice Root, while reducing the skin irritation of the drug, can effectively promote wound repair and accelerate drug penetration. The traditional Chinese medicine composition provided by the present invention has a wide source of raw materials, low cost, no toxic and side effects, is applicable to atopic dermatitis of damp-heat accumulation type, can greatly reduce the treatment cost, and relieve the family burden of patients.

[0041] Preferably, relative to 10 parts by weight of Cynanchum paniculatum, the content of Tripterygium wilfordii is 7.5 - 13.5 parts by weight, the content of Bletilla striata is 8.5 - 12 parts by weight, the content of Sepia seu Sepiella is 8.5 - 12 parts by weight, the content of Lemna minor is 7.5 - 13.5 parts by weight, the content of Mentha haplocalyx is 4 - 8.5 parts by weight, the content of Sophora flavescens is 7.5 - 13.5 parts by weight, the content of Phellodendron amurense is 7.5 - 13.5 parts by weight, the content of Paeonia suffruticosa is 6 - 9 parts by weight, and the content of Glycyrrhiza uralensis is 4 - 8.5 parts by weight. During the research process, it was found that controlling the dosage of each component in the above traditional Chinese medicine composition within the above range can further improve the compatibility effect between components, thereby further improving the therapeutic effect on atopic dermatitis. Considering that the therapeutic effect on atopic dermatitis can be further improved, more preferably, relative to 10 parts by weight of Cynanchum paniculatum, the content of Tripterygium wilfordii is 8 - 11.5 parts by weight, the content of Bletilla striata is 9 - 11 parts by weight, the content of Sepia seu Sepiella is 9 - 11 parts by weight, the content of Lemna minor is 8 - 12.5 parts by weight, the content of Mentha haplocalyx is 5.5 - 7 parts by weight, the content of Sophora flavescens is 8 - 11.5 parts by weight, the content of Phellodendron amurense is 8 - 11.5 parts by weight, the content of Paeonia suffruticosa is 4 - 8.5 parts by weight, and the content of Glycyrrhiza uralensis is 5.5 - 7 parts by weight.

[0042] As described above, the second aspect of the present invention provides a preparation method of a traditional Chinese medicine preparation for treating atopic dermatitis, and the method includes: mixing and heating traditional Chinese medicine raw materials with water, wherein the traditional Chinese medicine raw materials include Cynanchum paniculatum, Tripterygium wilfordii, Bletilla striata, Sepia seu Sepiella, Lemna minor, Mentha haplocalyx, Sophora flavescens, Phellodendron amurense, Paeonia suffruticosa and Glycyrrhiza uralensis.

[0043] The inventor found during the research process that by mixing and heating the above specific traditional Chinese medicine raw materials with water, the prepared traditional Chinese medicine preparation has a good therapeutic effect on atopic dermatitis through the mutual compatibility between Cynanchum paniculatum, Tripterygium wilfordii, Bletilla striata, Sepia seu Sepiella, Lemna minor, Mentha haplocalyx, Sophora flavescens, Phellodendron amurense, Paeonia suffruticosa and Glycyrrhiza uralensis, with a low recurrence rate and no toxic and side effects.

[0044] According to the present invention, the temperature of mixing and heating can be 90 - 110 °C, and the time of mixing and heating can be 0.3 - 0.8 h. Preferably, the number of times of mixing and heating can be 1 - 3 times. When the number of times of mixing and heating exceeds once, first separate the liquid obtained from the first mixing and heating from the system, then continue to add water for mixing and heating, and mix the liquids obtained from multiple times of mixing and heating.

[0045] Preferably, during each mixing and heating process, relative to 10 parts by weight of the traditional Chinese medicine raw materials, the dosage of water is 50 - 100 parts by weight.

[0046] Preferably, relative to 10 parts by weight of the Cynanchum paniculatum, the dosage of the Tripterygium wilfordii is 7.5 - 13.5 parts by weight, the dosage of the Bletilla striata is 8.5 - 12 parts by weight, the dosage of the Sepia seu Sepiella is 8.5 - 12 parts by weight, the dosage of the Lemna minor is 7.5 - 13.5 parts by weight, the dosage of the Mentha haplocalyx is 4 - 8.5 parts by weight, the dosage of the Sophora flavescens is 7.5 - 13.5 parts by weight, the dosage of the Phellodendron amurense is 7.5 - 13.5 parts by weight, the dosage of the Paeonia suffruticosa is 6 - 9 parts by weight, and the dosage of the Glycyrrhiza uralensis is 4 - 8.5 parts by weight. During the research process, it was found that there is a better compatibility effect among the components in the above dosages, thereby being able to further improve the therapeutic effect on atopic dermatitis. Considering that the therapeutic effect on atopic dermatitis can be further improved, more preferably, relative to 10 parts by weight of the Cynanchum paniculatum, the dosage of the Tripterygium wilfordii is 8 - 11.5 parts by weight, the dosage of the Bletilla striata is 9 - 11 parts by weight, the dosage of the Sepia seu Sepiella is 9 - 11 parts by weight, the dosage of the Lemna minor is 8 - 12.5 parts by weight, the dosage of the Mentha haplocalyx is 5.5 - 7 parts by weight, the dosage of the Sophora flavescens is 8 - 11.5 parts by weight, the dosage of the Phellodendron amurense is 8 - 11.5 parts by weight, the dosage of the Paeonia suffruticosa is 4 - 8.5 parts by weight, and the dosage of the Glycyrrhiza uralensis is 5.5 - 7 parts by weight.

[0047] According to the present invention, the above traditional Chinese medicine preparation can be an external preparation. The external preparation can be an external ointment, an external liquid preparation, and a microemulsion gel. The external ointment can be an ointment obtained by concentrating the liquid obtained by the above mixing and heating, or can be an ointment obtained by concentrating the mixture of the liquid obtained by the above mixing and auxiliary materials, or the liquid obtained by the above mixing and heating can be directly used externally as a liquid preparation, or a liquid preparation obtained by mixing the obtained ointment with water, or the liquid obtained by the above mixing and heating is prepared into a microemulsion gel. The preparation method of the above preparation can adopt the preparation methods disclosed in the prior art. The above external preparation can effectively reduce the discomfort during use, and patients will not scratch during use, affecting the absorption of the traditional Chinese medicine composition. Moreover, when the traditional Chinese medicine composition is made into a microemulsion gel, it has high permeability, high bioavailability, good moisturizing effect, high patient compliance, and can relieve the discomfort caused by dermatitis.

[0048] In a specific embodiment of the present invention, the method further includes: concentrating the liquid obtained by the above mixing and heating to obtain an extract. Preferably, the temperature of the concentration is 65 - 75 °C. The time of the concentration is not particularly limited as long as a paste can be formed. Preferably, the density of the extract is 1.20 - 1.25 g / mL. This extract has a better therapeutic effect.

[0049] Preferably, the method further includes: soaking the traditional Chinese medicine raw materials in water for 20 - 60 min before mixing and heating.

[0050] The present invention will be described in detail below by way of examples.

[0051] Unless otherwise specified, the reagents and traditional Chinese medicine raw materials used can be obtained from commercial sources without special instructions.

[0052] Example 1 Take 12 parts of Cynanchum paniculatum, 9 parts of Tripterygium wilfordii, 14 parts of Bletilla striata, 14 parts of Sepia seu cuttlebone, 9 parts of Lemna minor, 10 parts of Mentha haplocalyx, 9 parts of Sophora flavescens, 9 parts of Phellodendron amurense, 10 parts of Paeonia suffruticosa, and 10 parts of Glycyrrhiza uralensis, put them into a decocting container, add 6 times the amount of water and soak for 30 minutes, decoct for 30 minutes for the first time, add 5 times the amount of water and decoct for 20 minutes for the second time, combine the decoction, concentrate and filter to obtain Extract-1.

[0053] Example 2 Take 9 parts of Cynanchum paniculatum, 12 parts of Tripterygium wilfordii, 8 parts of Bletilla striata, 8 parts of Sepia seu cuttlebone, 12 parts of Lemna minor, 4 parts of Mentha haplocalyx, 12 parts of Sophora flavescens, 12 parts of Phellodendron amurense, 8 parts of Paeonia suffruticosa, and 4 parts of Glycyrrhiza uralensis, put them into a decocting container, add 10 times the amount of water and soak for 30 minutes, decoct for 50 minutes for the first time, add 7 times the amount of water and decoct for 40 minutes for the second time, combine the decoction, concentrate and filter to obtain Extract-2.

[0054] Example 3 Take 10 parts of Cynanchum paniculatum, 10 parts of Tripterygium wilfordii, 10 parts of Bletilla striata, 10 parts of Sepia seu cuttlebone, 10 parts of Lemna minor, 6 parts of Mentha haplocalyx, 10 parts of Sophora flavescens, 10 parts of Phellodendron amurense, 6 parts of Paeonia suffruticosa, and 6 parts of Glycyrrhiza uralensis, put them into a decocting container, add 8 times the amount of water and soak for 30 minutes, decoct for 40 minutes for the first time, add 6 times the amount of water and decoct for 30 minutes for the second time, combine the decoction, concentrate and filter to obtain Extract-3.

[0055] Example 4 Take 12 parts of Cynanchum paniculatum, 10 parts of Tripterygium wilfordii, 13 parts of Bletilla striata, 13 parts of Sepia seu cuttlebone, 10 parts of Lemna minor, 8 parts of Mentha haplocalyx, 10 parts of Sophora flavescens, 10 parts of Phellodendron amurense, 10 parts of Paeonia suffruticosa, and 8 parts of Glycyrrhiza uralensis, put them into a decocting container, add 6 times the amount of water and soak for 30 minutes, decoct for 30 minutes for the first time, add 5 times the amount of water and decoct for 20 minutes for the second time, combine the decoction, concentrate and filter to obtain Extract-4.

[0056] Example 5 Take 9 parts of Cynanchum paniculatum, 10 parts of Tripterygium wilfordii, 8.5 parts of Bletilla striata, 8.5 parts of Sepia seu cuttlebone, 11 parts of Lemna minor, 5 parts of Mentha haplocalyx, 10 parts of Sophora flavescens, 10 parts of Phellodendron amurense, 4 parts of Paeonia suffruticosa, and 5 parts of Glycyrrhiza uralensis, put them into a decocting container, add 10 times the amount of water and soak for 30 minutes, decoct for 50 minutes for the first time, add 7 times the amount of water and decoct for 40 minutes for the second time, combine the decoction, concentrate and filter to obtain Extract-5.

[0057] Comparative Example 1 Obtain the extract according to the method of Example 3, except that Cynanchum paniculatum is not added.

[0058] Comparative Example 2 The extract was obtained by the method of Example 3, except that Tripterygium wilfordii was not added.

[0059] Comparative Example 3 The extract was obtained by the method of Example 3, except that Bletilla striata was not added.

[0060] Comparative Example 4 The extract was obtained by the method of Example 3, except that Sepia seu Sepiella was not added.

[0061] Test Example 1 Preparation of DNCB solution: Weigh 20 mg of 1-chloro-2,4-dinitrobenzene (DNCB) powder precisely and place it in a mixed solution of 2000 μL of acetone and olive oil (3:1) to prepare a 2 mL 1% DNCB modeling solution.

[0062] Weigh 10 mg of 1-chloro-2,4-dinitrobenzene (DNCB) powder precisely and place it in a mixed solution of 2000 μL of acetone and olive oil (3:1) to prepare a 2 mL 0.5% DNCB modeling solution.

[0063] Select a 2 cm × 2 cm area of skin on the back of the mouse, and remove the hair on the back one day before the experiment. On the 1st, 4th, and 7th days of the experiment, apply 200 μL of 1% DNCB mixed solution to the back each time. Do not perform any treatment from the 8th to the 13th day. After the 14th day, apply 200 μL of 0.5% DNCB mixed solution every 2 days until the 28th day. Observe whether there are any signs of desquamation, erythema, etc. on the back of the mouse. If they appear, it means the model preparation is successful. Finally, a total of 90 successfully modeled mice were selected, and another 10 non-modeled mice were taken as the blank control group, for a total of 100 mice to enter the subsequent experiment.

[0064] The medicinal liquids obtained in the examples and comparative examples were respectively heated and concentrated to an extract with a relative density of 1.2 g / mL. Each traditional Chinese medicine extract was added with distilled water to prepare a medicinal liquid of 1 g extract / mL for standby.

[0065] Except for the blank control group, the prepared model mice were randomly divided into 9 groups, namely the model group, Example 1-5 groups, and Comparative Example 1-4 groups, with 10 mice in each group. After the model preparation, 200 μL of the corresponding medicinal liquid was applied to the skin at the lesion site on the back of the mice in Example 1-5 groups and Comparative Example 1-4 groups for two consecutive weeks; the mice in the model group were smeared with the same volume of distilled water instead.

[0066] During the whole experiment, different degrees of AD-like reactions appeared on the backs of the mice after modeling. The specific symptoms included obvious skin erythema, dryness, epidermal erosion, exfoliation and crusting, etc. After receiving drug treatment, the symptoms of the mice in the example group and the comparative example group in the modeling area were significantly improved. The number of erythemas decreased, and the conditions of crusting and skin erosion were gradually alleviated. Among them, the treatment effect of the mice in the example group was better, especially the treatment effect of the mice in Example 3 group was particularly prominent. The bleeding points of skin damage, dry scales and lichenoid lesions of the skin were significantly reduced or improved. See Figure 1 .

[0067] The atopic dermatitis score referred to the SCORAD scoring standard: After the last administration, according to the conditions of erythema, epidermal exfoliation, scales, papules or edema, exudation or crusting on the back, it was divided into 4 grades: none, mild, moderate and severe, marked 0, 1, 2, 3 points respectively. The total score was the sum of the symptom scores. The higher the score, the more serious the skin damage degree was.

[0068] The observation of the scratching behavior of the mice referred to the standards of KURAISHI et al. After the last administration in the experiment, the number of times the seven groups of mice scratched the shaved area was counted. The statistical duration of the scratching times of each group of mice was 10 minutes. The continuous scratching of the back by the hind limbs was regarded as 1 scratching activity. When the hind paw landed or was licked, it represented the end of this scratching activity. The continuous long-term scratching was counted as 1 time.

[0069] After the last administration, the mice were weighed and their body weights were recorded. After the mice were anesthetized, blood was taken from the eyeballs, left standing at room temperature for 2 h, centrifuged at 3000 r / min for 15 min, and then the supernatant was taken for standby.

[0070] Refer to the instructions to prepare standard product solutions with different concentrations by gradient dilution. Add the standard products and the samples to be tested in turn, gently mix them, and then incubate them in a water bath at 37 °C for 30 min. Add the IgE antibody diluent and incubate in a water bath at 37 °C for 30 min. Add the avidin peroxidase complex and incubate at 37 °C for 30 min. After washing with the washing solution and drying by centrifugation, add the termination solution to terminate the reaction after the color reaction. Measure the absorbance A value of the sample to be tested at a wavelength of 450 nm in an enzyme-linked immunosorbent assay (ELISA) reader, establish a standard product regression curve, and calculate the concentration according to the A value of the sample to be tested.

[0071] After treating the atopic dermatitis model mice with the extraction solution of the example or the comparative example for two weeks, the damaged skin scores, scratching times and IgE levels in the serum of the mice in each test group were shown in Table 1.

[0072] Table 1 Comparison of damaged skin scores, scratching times and IgE levels (n = 10)

[0073] As can be seen from the above table, compared with the blank control group, the damaged skin score of the mice in the model group was significantly increased, and pathological manifestations such as erythema, epidermal exfoliation, and scabbed skin lesions appeared on the back. The scratching times increased significantly, and the serum IgE level of the mice was significantly increased. After treatment with the traditional Chinese medicine composition of the present invention for 2 weeks, the skin of the mice improved significantly, the scabs gradually decreased, and the damaged skin score, scratching times of the mice, and IgE level in the serum of the mice were significantly lower than those in the model control group and Comparative Examples 1-4 (the differences were statistically significant), which confirmed that the traditional Chinese medicine composition of the present invention has a significant effect on the treatment of atopic dermatitis.

[0074] Test Example 2 Retrospective analysis was performed on patients with atopic dermatitis who visited the dermatology outpatient department of our hospital from January 2023 to December 2024. A total of 60 cases were included. Excluding 3 cases with lost to follow-up, a total of 57 patients completed the clinical observation, including 29 male patients and 28 female patients, aged from 6 to 75 years old, with an average age of 36.80 ± 0.600 years.

[0075] Patients with atopic dermatitis who visited the dermatology department met the diagnostic criteria of Williams for atopic dermatitis in "Clinical Dermatology" (edited by Zhao Bian, 2001 edition), and the patients had no history of using antibiotics, antifungal agents, and glucocorticoid drugs in the past month. The observed skin lesions had not received any local treatment (except for emollients) within 1 week; the rash was in the subacute stage and was symmetrically distributed; a written informed consent form was signed.

[0076] Exclusion criteria: patients with other skin diseases; those receiving systemic immunosuppressants and glucocorticoid treatment (including systemic and local medications); patients with other major underlying diseases such as cardiopulmonary diseases; patients with mental diseases.

[0077] The medicinal liquid prepared by extracting the extract in Example 3 for external use was continuously treated for 7-14 days, twice a day, and evenly applied externally to the exudative rash area.

[0078] The skin lesion symptoms included erythema, edema, exudation, desquamation, lichenification, and dryness. Each symptom was scored according to a four-level standard of 0-3. The total score of the skin lesion severity was the sum of the scores of each skin lesion symptom. The observation time points were day 0, day 3, and day 7 (the observation time window was ±1 day).

[0079] The overall improvement rate = (pre-treatment score - post-treatment score) / pre-treatment score × 100%. According to the overall improvement rate, the curative effect of the subjects was divided into cured (greater than or equal to 90%), markedly effective (greater than or equal to 60% and less than 90%), effective (greater than or equal to 30% and less than 60%), and ineffective (less than 30%). The total effective rate was the sum of cured, markedly effective, and effective.

[0080] After 7 - 14 days of medication, 0 cases were cured, 15 cases showed marked improvement, 42 cases were effective, and 5 cases were ineffective. The total effective rate was 91.23%. No obvious adverse reactions were observed in all patients.

[0081] Through this clinical study, it is shown that this traditional Chinese medicine composition has the effects of rapidly reducing skin lesions and relieving itching. In the treatment of patients with atopic dermatitis, the formulated medicine of the present invention has a mild property, and has the effects of clearing heat and promoting diuresis, detoxifying and dredging collaterals, etc. Through long - term clinical observation, it is found that the formulated medicine of the present invention has a quick onset of effect, good curative effect, is not easy to relapse, has small toxic and side effects, high safety, is convenient to use, and has a high acceptance rate among patients and their parents. At the same time, it has the advantages of simple, reasonable preparation and wide drug sources.

[0082] Typical cases of the clinical application of the traditional Chinese medicine composition of the present invention: Case 1: Patient Yin, female, 17 years old.

[0083] Three years ago, the patient developed skin rashes and itching without obvious inducement, which was obvious when the temperature alternated between hot and cold. Oral administration of cetirizine relieved the symptoms. The current symptoms are scattered erythema, papules, maculopapules on the buttocks and legs, dry skin, desquamation, skin itching, which is obvious when the hot and cold air alternates, no fever, no cough, occasional sneezing, restless sleep, sweating on the head during sleep, going to bed late, preferring meat - based diet, nail - biting, occasional abdominal pain, dry stools, once every 2 - 3 days, and yellow urine. The tongue is light red, the tongue coating is white and greasy, and the pulse is slippery and rapid. Past medical history includes eczema, urticaria, mycoplasma infection, and history after adenoid resection. The mother has a history of urticaria. Traditional Chinese medicine diagnosis: Damp sore (damp - toxin accumulating in the skin); Western medicine diagnosis: Atopic dermatitis. The medicinal liquid prepared from the extract of Example 3 of the present invention was externally applied. At the second diagnosis, the rash improved compared with before. Continue to apply the above - mentioned medicine externally for 7 doses. Subsequently, the patient's rash continued to improve, and Figure 2 .

[0084] Case 2: Patient Jiang, male, 27 years old.

[0085] Scattered erythema and papules symmetrically appeared on the patient's lower extremities, with local exudation and accompanied by itching. The rash aggravated in the recent week, with obvious itching, and obvious dandruff and exudate could be seen after scratching locally. No fever, no cough, poor appetite, less intake of vegetables, restless sleep, night sweats, relatively dry stools, relatively yellow urine. The father has a history of allergic rhinitis. Traditional Chinese medicine diagnosis: Damp sore (damp - toxin accumulating in the skin); Western medicine diagnosis: Atopic dermatitis. The medicinal liquid prepared from the extract of Example 3 of the present invention was externally applied. At the second diagnosis, the rash improved compared with before. Continue to apply the above - mentioned medicine externally for 7 doses. Subsequently, the patient's rash continued to improve, and Figure 3 .

[0086] Case 3: Patient Lü, male, 45 years old.

[0087] The patient presented with scattered erythema, papules, and maculopapules on the trunk and limbs, skin desquamation, itching, exudation visible after local scratching, no fever, no cough, dry and itchy eyes, normal appetite, restlessness at night, spontaneous sweating, night sweating, dry stools, and yellowish urine. The tongue was red, the coating was thick and white and greasy, and the pulse was slippery and rapid. The patient had a history of allergic rhinitis and urticaria. Traditional Chinese medicine diagnosis: Siwanfeng (damp-toxin accumulating in the skin); Western medicine diagnosis: atopic dermatitis. The patient was externally applied with the medicinal liquid prepared from the extract of Example 3 of the present invention. At the second consultation, the rash improved compared with before. The above prescription was continued to be applied externally for 7 doses. Subsequently, the patient's rash continued to improve and showed Figure 4 .

[0088] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited thereto. Within the scope of the technical concept of the present invention, various simple modifications can be made to the technical solutions of the present invention, including any other suitable combination of each technical feature. These simple modifications and combinations should also be regarded as the content disclosed by the present invention and fall within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating atopic dermatitis, characterized in that: The traditional Chinese medicine composition contains Cynanchum chinense, Tripterygium wilfordii, Bletilla striata, Cuttlebone, Duckweed, Mentha arvense, Sophora flavescens, Phellodendron chinense, Paeonia suffruticosa and Licorice.

2. The Chinese medicine composition according to claim 1, characterized in that: Relative to 10 parts by weight of the Cynanchum wilfordii, the content of the Tripterygium wilfordii is 7.5-13.5 parts by weight, the content of the Bletilla striata is 8.5-12 parts by weight, the content of the Cuttlebone is 8.5-12 parts by weight, the content of the Duckweed is 7.5-13.5 parts by weight, the content of the Mint is 4-8.5 parts by weight, the content of the Sophora flavescens is 7.5-13.5 parts by weight, the content of the Phellodendron chinense is 7.5-13.5 parts by weight, the content of the Paeonia suffruticosa is 6-9 parts by weight, and the content of the Licorice is 4-8.5 parts by weight.

3. The Chinese medicine composition according to claim 2, characterized in that: Relative to 10 parts by weight of the Cynanchum wilfordii, the content of the Tripterygium wilfordii is 8-11.5 parts by weight, the content of the Bletilla striata is 9-11 parts by weight, the content of the Cuttlebone is 9-11 parts by weight, the content of the Duckweed is 8-12.5 parts by weight, the content of the Mint is 5.5-7 parts by weight, the content of the Sophora flavescens is 8-11.5 parts by weight, the content of the Phellodendron chinense is 8-11.5 parts by weight, the content of the Paeonia suffruticosa is 4-8.5 parts by weight, and the content of the Licorice is 5.5-7 parts by weight.

4. A method for preparing a Chinese medicine preparation for treating atopic dermatitis, characterized in that: The method comprises: mixing the Chinese medicine raw material and water and heating them; The Chinese medicinal raw materials include Cynanchum wilfordii, Tripterygium wilfordii, Bletilla striata, Cuttlebone, Duckweed, Menthus fragrans, Sophora flavescens, Phellodendron amurense, Paeonia suffruticosa and Licorice.

5. The preparation method according to claim 4, characterized in that: Relative to 10 parts by weight of the Cynanchum wilfordii, the amount of the Tripterygium wilfordii is 7.5-13.5 parts by weight, the amount of the Bletilla striata is 8.5-12 parts by weight, the amount of the Cuttlebone is 8.5-12 parts by weight, the amount of the Duckweed is 7.5-13.5 parts by weight, the amount of the Mint is 4-8.5 parts by weight, the amount of the Sophora flavescens is 7.5-13.5 parts by weight, the amount of the Phellodendron chinense is 7.5-13.5 parts by weight, the amount of the Paeonia suffruticosa is 6-9 parts by weight, and the amount of the Licorice is 4-8.5 parts by weight.

6. The preparation method according to claim 5, characterized in that: Relative to 10 parts by weight of the Cynanchum wilfordii, the amount of the Tripterygium wilfordii is 8-11.5 parts by weight, the amount of the Bletilla striata is 9-11 parts by weight, the amount of the Cuttlebone is 9-11 parts by weight, the amount of the Duckweed is 8-12.5 parts by weight, the amount of the Mint is 5.5-7 parts by weight, the amount of the Sophora flavescens is 8-11.5 parts by weight, the amount of the Phellodendron chinense is 8-11.5 parts by weight, the amount of the Paeonia suffruticosa is 4-8.5 parts by weight, and the amount of the Licorice is 5.5-7 parts by weight.

7. The preparation method according to any one of claims 4 to 6, characterized in that: The method further comprises: concentrating the liquid obtained by mixing and heating to obtain an extract.

8. The preparation method according to claim 7, characterized in that: The density of the extract is 1.20-1.25 g / mL.

9. The Chinese medicine preparation obtained by the preparation method according to any one of claims 4 to 8.

10. Use of the Chinese medicine composition according to any one of claims 1 to 3 or the Chinese medicine preparation according to claim 9 in the preparation of a drug for treating atopic dermatitis; Preferably, the atopic dermatitis is damp-heat-skin type atopic dermatitis.

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