Traditional Chinese medicine external preparation for treating pruritic immune dermatosis and application of traditional Chinese medicine external preparation

Abstract

The invention provides a traditional Chinese medicine external preparation for treating pruritic immune skin diseases and application. The traditional Chinese medicine external preparation is prepared from the following raw material medicines in parts by weight: 9-11 parts of cortex phellodendri, 9-11 parts of radix sophorae flavescentis, 9-11 parts of fructus cnidii, 9-11 parts of rhizoma atractylodis, 9-11 parts of rhizoma atractylodis macrocephalae and 9-11 parts of radix sanguisorbae. According to the skin lesion characteristics of dermatitis and eczema, the traditional Chinese medicine external preparation is high in percutaneous absorption capacity, directly reaches the deep part of the skin lesion and has the effects of clearing away heat and toxic materials and eliminating dampness and relieving itching. The traditional Chinese medicine external preparation has a remarkable treatment effect, is clinically used for treating the pruritic and immune skin diseases, and is particularly suitable for the pruritic and immune skin diseases such as eczema and atopic dermatitis.

Description

Technical Field

[0001] The invention relates to a traditional Chinese medicine external preparation for treating pruritic immune skin diseases and application thereof, belonging to the field of traditional Chinese medicine. Background Art

[0002] Pruritus / immune dermatosis is a common inflammatory skin disease caused by a variety of internal and external factors, including infectious and non-infectious factors. Its clinical features are mainly manifested as itching, erythematous papules, papulovesicles, blisters, redness, swelling or exudation, sometimes covered with crusts. As a representative of this type of disease, dermatitis and eczema, which usually develops in childhood and may persist into adulthood, are characterized by recurrent chronic eczematoid lesions, skin sensitivity and itching, often accompanied by seasonal fluctuations. Some patients may also have respiratory allergic diseases (such as asthma, allergic rhinitis) as well as cardiovascular and neuropsychiatric disorders. The pathogenesis of these diseases is mainly related to the action of environmental factors (such as allergens, scratching, pathogenic microorganisms, etc.) on genetically susceptible individuals, which leads to immune dysregulation and activation of specific inflammatory factor pathways, inducing systemic allergic reactions and immune dysfunction. At present, conventional treatment methods of Western medicine mainly rely on topical hormones, antihistamines and immunomodulators, but long-term use of these drugs may cause many side effects, such as skin atrophy and immunosuppression, and the recurrence rate is extremely high.

[0003] According to traditional Chinese medicine, the occurrence of pruritic skin diseases is closely related to the invasion of exogenous pathogens (such as rheumatism and dampness), viscera disorders, and immune abnormalities. Dampness and wind evil invade the skin, causing itching and inflammation. Especially in the acute stage of eczema, moisture and dampness interact with each other, manifesting as skin redness, swelling, and exudation. In addition, blood heat and dampness caused by the failure of the surface to close will further aggravate skin inflammation. In this context, traditional Chinese medicine emphasizes the treatment of such diseases by means of harmonizing the viscera, removing dampness and detoxifying, and clearing heat and relieving itching. This Chinese patent medicine has multiple effects such as clearing heat and detoxifying, drying dampness and relieving itching, and cooling blood and removing wind, which can regulate immune response and relieve inflammation.

[0004] This study also systematically combed through patent technical documents with similar efficacy to the present application, among which patent publication number CN116672383A records: A Chinese medicine composition for treating eczema, made from the following raw materials by weight: 3-7 parts of Sophora flavescens, 2-4 parts of Cyperus rotundus, 1-5 parts of Gentiana scabra, 3-7 parts of Scutellaria baicalensis, 3-7 parts of Kochia scoparia, 3-7 parts of Dictamni, 2-6 parts of Rubia cordifolia, 1-5 parts of Lithospermum officinale, and 3-7 parts of Eclipta prostrata. This Chinese medicine composition can effectively treat acute and chronic eczema. Clinical trials show that it improves the area and severity index of eczema, has few toxic and side effects, and is easy to use. CN114732881A A Chinese medicine external composition for treating chronic perianal eczema. It is prepared from the following raw materials in proportion by weight: 15-20 parts of Radix Rehmanniae, 15-20 parts of Angelicae Sinensis, 8-15 parts of Radix Ophiopogonis, 8-15 parts of Semen Persicae, 8-15 parts of Radix Scrophulariae, 8-15 parts of Rhizoma Atractylodis Macrocephalae, 8-15 parts of Rhizoma Atractylodis Macrocephalae, 8-15 parts of Poria, 8-15 parts of Saposhnikovia Divaricata, 8-15 parts of Fructus Cnidium, 8-15 parts of Cortex Dictamni, 8-15 parts of Polygonum Multiflorum, 8-15 parts of Radix Stemonae, 8-15 parts of Cortex Meliae, 8-12 parts of Sophora flavescens, 8-12 parts of Cortex Pittosporum, 8-15 parts of Herba Siegesbeckiae, 8-15 parts of Cortex Phellodendri, 8-15 parts of Smilax glabrae, 8-12 parts of Bombyx Batryticatus and 6-10 parts of Periostracum Cicadae. The external preparation has the effects of nourishing blood and moistening dryness, strengthening the spleen and removing dampness, dispelling wind and relieving itching, and clearing away dampness and heat.

[0005] Although there are many traditional Chinese medicines for the treatment of pruritic skin diseases, there are some defects. For example, there are too many medicinal flavors in the traditional Chinese medicine compound, some ingredients may cause allergies, and the clinical efficacy is not ideal. In addition, the existing traditional Chinese medicine treatment still has certain limitations in terms of permeability, stability and onset time. Therefore, it is particularly important to develop a more effective traditional Chinese medicine preparation for the treatment of pruritic / immune skin diseases to meet the new needs of clinical treatment plans. Summary of the invention

[0006] The present invention provides a Chinese medicine external preparation for treating pruritic immune skin diseases and its application. The Chinese medicine external preparation has the advantages of simple formula and compatibility, significant clinical efficacy and small side effects. It also has the advantages of good patient compliance and convenient administration in clinical application. The Chinese medicine full formula has the effects of clearing away heat and detoxifying, drying dampness and relieving itching.

[0007] The present invention also combines modern drug preparation technology, through reasonable drug compatibility and preparation process, can make the effective components of traditional Chinese medicine quickly penetrate the skin, take effect quickly, and have low side effects, low long-term recurrence rate, and have the effects of clearing away heat and detoxification, anti-inflammatory, antipruritic and astringent. Animal experiments show that it can effectively treat DNFB-induced atopic dermatitis mouse model, improve skin lesions, relieve epidermal thickening, reduce mast cell infiltration, reduce spleen and lymph node enlargement, reduce the number of scratching, reduce the level of inflammatory factors, etc. Clinically, it is mainly used to treat eczema and dermatitis caused by dampness and heat, rheumatism, etc., immune skin diseases, and is particularly suitable for patients in the acute and subacute stages of eczema.

[0008] The Chinese medicine prescription for treating pruritus and immune skin diseases of the present invention is derived from the classic prescription based on the traditional prescription "Two Wonderful Prescriptions" under the guidance of the basic theory of traditional Chinese medicine. The optimal components and dosage ratios are summarized after a large number of clinical practice explorations by the inventors based on clinical efficacy feedback. The dosage of each component has good clinical efficacy within the following weight range.

[0009] The technical solution of the patent application of this invention is: A traditional Chinese medicine external preparation for treating pruritic skin diseases, the traditional Chinese medicine external preparation comprising the following raw materials in proportion by weight: 9-11 parts of phellodendron, 9-11 parts of sophora flavescens, 9-11 parts of cnidium monnieri, 9-11 parts of atractylodes, 9-11 parts of atractylodes, 9-11 parts of white atractylodes, and 9-11 parts of sanguisorba officinalis.

[0010] As a preferred embodiment of the present invention, the Chinese medicine external preparation comprises raw materials in the following weight ratio: 10 parts of Phellodendron chinense, 10 parts of Sophora flavescens, 10 parts of Cnidium monnieri, 10 parts of Atractylodes macrocephala, 10 parts of Atractylodes macrocephala, and 10 parts of Sanguisorba officinalis.

[0011] As a preferred embodiment of the present invention, the preparation method comprises the following steps: Step (1): taking the medicinal materials of Phellodendron chinense, Sophora flavescens, Cnidium monnieri, Atractylodes lancea, Atractylodes macrocephala, and Sanguisorba officinalis in the weight ratio, soaking them in water, adding 8 to 14 times the weight of the above medicinal materials in water, decocting them 1 to 3 times for 0.5 to 3 hours, filtering, and combining the above decoction filtrates; Step ⑵: Take the decocted filtrate of step ⑴, and concentrate it under reduced pressure at 65-85° C. to a clear paste with a relative density of 1.10-1.15. After concentration, add the clear paste liquid, and then add the pharmaceutical excipients, stir and mix evenly to prepare a Chinese medicine external preparation.

[0012] As a further preferred embodiment of the present invention, it is characterized in that the preparation method comprises the following steps (1): Take the medicinal materials of Phellodendron chinense, Sophora flavescens, Cnidium monnieri, Atractylodes lancea, Atractylodes macrocephala, and Sanguisorba officinalis in the above weight ratio, add 12 to 14 times the weight of the above medicinal materials in water, soak in water for 1 to 2 hours, decoct in water twice, the first decoction time is 1.5 to 3 hours, the second decoction time is 10 to 12 times the weight of the above medicinal materials in water, the second decoction time is 1 to 2 hours, filter, and combine the above decoction filtrates.

[0013] As a preferred embodiment of the present invention, the concentration temperature of step (2) of the preparation method is 70°C.

[0014] Preferably, the pharmaceutical excipients in step (2) of the preparation method are: one or more combinations of carbomer, triethanolamine, glycerol, and sodium carboxymethyl cellulose.

[0015] As a preferred embodiment of the present invention, the dosage form of the Chinese medicine external preparation can be: ointment, gel, liniment, spray, paste.

[0016] The external preparation is not limited to the above-mentioned preferred dosage forms, and may also be a patch, a lotion, a tincture, and the like.

[0017] Preferably, the traditional Chinese medicine external preparation is used in the preparation of a drug for treating immune skin diseases.

[0018] Preferably, the traditional Chinese medicine external preparation is used in the preparation of medicines for treating eczema and dermatitis.

[0019] Preferably, the traditional Chinese medicine external preparation is used in the preparation of medicines for treating skin diseases such as atopic dermatitis, folliculitis, neurodermatitis, and hormonal dermatitis.

[0020] The application method of the Chinese herbal external preparation for improving various types of dermatitis with itching as the main symptom is as follows: the Chinese herbal external preparation can be thinly applied to the affected area 2-3 times a day.

[0021] The etiology and pathogenesis of pruritic skin diseases treated by the Chinese medicine external preparation of the present invention are as follows: This disease is often closely related to factors such as exogenous invasion, visceral disorders, and immune dysfunction. "Exogenous evil attacks the surface": external moisture or wind evil invades the human body, and the dampness evil accumulates. The wind evil often acts together with moisture, causing itching and inflammatory reactions of the skin, especially in the acute eczema stage, the itching is particularly obvious. "Internal dampness and heat": the interaction between endogenous moisture and dampness and heat causes the skin surface to show redness, swelling, and exudation; "Blood dryness and wind prevail": blood deficiency cannot nourish the skin, while blood heat promotes local inflammatory reactions, forming redness, swelling, exudation, itching and pain on the skin; at the same time, immune skin diseases such as atopic dermatitis are often accompanied by immune dysfunction, abnormally enhanced immune responses in the body or persistent allergic reactions, leading to excessive inflammatory reactions of the skin, forming symptoms such as itching and redness. Environmental factors and genetic susceptibility: External stimuli such as dry climate, air pollution, allergens, and pathogenic microorganisms can trigger the disease. In addition, the occurrence of diseases such as atopic dermatitis is related to the genetic background. The incidence rate is higher in people with allergic diseases in their family history.

[0022] The therapeutic principles of the Chinese medicine prescription of the present invention are as follows: This prescription carefully selects six medicinal materials, including Phellodendron chinense, Sophora flavescens, Cnidium monnieri, Atractylodes lancea, Atractylodes macrocephala, and Sanguisorba officinalis, and determines the corresponding treatment principles based on the pathogenesis characteristics of the disease. ① Clearing away heat and drying dampness is the core treatment method for these diseases. By clearing away heat and detoxifying, the toxic evil in the body can be removed, and local inflammatory reactions such as redness, swelling, and itching can be alleviated. Phellodendron chinense and Sophora flavescens are used in the prescription to clear heat and dry dampness, detoxify and kill insects; ② Dispel wind and stop itching: Eczema is often accompanied by wind evil, which is an important factor causing skin itching. The Cnidium monnieri added in the prescription has the effect of dispelling wind and relieving itching, and can relieve skin discomfort caused by wind evil; ③. Drying dampness: The Chinese medicinal materials such as Atractylodes lancea and Atractylodes macrocephala used in the prescription have the effects of drying dampness, promoting diuresis and strengthening the spleen, which can improve dampness retention, and relieve skin inflammation and itching and pain symptoms by eliminating dampness and dampness in the body; ④. Regulating the spleen and stomach functions and enhancing the spleen's transportation and transformation capabilities are crucial for the treatment of dampness-related skin diseases such as eczema. Atractylodes macrocephala can strengthen the spleen and replenish qi, promote diuresis and eliminate dampness, which can help improve pathological conditions such as dampness retention and promote the recovery of eczema.

[0023] The formula of the Chinese medicine prescription of the present invention is explained as follows: This prescription uses Phellodendron chinense as the main drug. It is bitter and cold in nature. It enters the kidney, bladder, and large intestine meridians. It has the effects of clearing away heat and dampness, purging fire and removing steam, and detoxifying and curing sores. External application can directly reach the skin pores and inhibit exudative itching. It is especially suitable for skin diseases caused by dampness and heat such as eczema and dermatitis. Phellodendron chinense relieves skin redness, swelling, and itching by reducing the accumulation of dampness and heat in the body; it can also inhibit bacterial infection and promote the disappearance of local inflammation. This prescription is combined with Sophora flavescens and Cnidium monnieri are the ministerial drugs. Sophora flavescens is bitter and cold in nature, and enters the heart, lung, kidney, and large intestine meridians; Cnidium monnieri is pungent and warm in nature, and enters the kidney and spleen meridians. Both of them can clear away heat and dampness, dispel wind and kill insects, and can assist and enhance the heat-clearing and dampness-clearing effect of Phellodendron chinense. In addition, Cnidium monnieri can regulate immune response and has obvious therapeutic effects on immune skin diseases such as atopic dermatitis. Its unique antipruritic effect can effectively reduce skin itching caused by allergic reactions and abnormal immune system.

[0024] This prescription is supplemented with bran-fried Atractylodes, bran-fried Atractylodes and raw Sanguisorba officinalis, which are adjuvants. Among them, bran-fried Atractylodes and bran-fried Atractylodes are bitter, warm in nature, and enter the spleen and stomach meridians. Both can invigorate the spleen and eliminate dampness, regulate the spleen and stomach functions, promote the discharge of moisture from the human body, assist the monarch and ministerial drugs to enhance their dampness-drying effect, relieve the itching and exudation of the skin, and have a good alleviating effect on skin inflammation caused by moisture. Raw Sanguisorba officinalis is bitter and sour in nature and slightly cold in nature. It enters the liver and large intestine meridians and has the effects of clearing away heat and detoxifying, cooling blood and stopping bleeding. Its heat-clearing and detoxifying properties can promote the healing of the skin, especially for the skin symptoms of exudation and ulceration caused by damp-heat burning.

[0025] The combination of all the herbs in the prescription can achieve multiple effects of clearing away heat and detoxification, drying dampness and relieving itching, cooling blood and removing wind, and strengthening the spleen and removing dampness. It can regulate the causes of dampness and heat, wind evil, and relieve symptoms such as skin redness, swelling, itching, and exudation; it can also regulate the internal organs and reduce allergic reactions caused by abnormal immune system, achieving the effect of treating both the symptoms and the root causes. In addition, the prescription focuses on the combination of dryness and astringency in the process of compatibility: the dryness of Atractylodes lancea and Sophora flavescens is combined with the astringency of Sanguisorba officinalis, which conforms to the treatment principle of "controlling exudation in the acute stage and preventing dryness and cracking in the chronic stage" for itchy skin diseases such as eczema.

[0026] Beneficial effects of the Chinese medicine external preparation of the present invention ⑴. The Chinese medicine external preparation of the present invention is the core inventor Professor Zheng Yan's practical experience in clinical Chinese medicine for many years, based on a large number of clinical patients' efficacy feedback, and continuously summarized and optimized. The Chinese medicine prescription for treating itching is a classic prescription based on the traditional famous prescription "Two Wonderful Prescriptions" under the guidance of the basic theory of Chinese medicine. The prescription is composed of multiple medicines such as Phellodendron, Sophora flavescens, Cnidium monnieri, bran-fried Atractylodes, bran-fried Atractylodes, and Radix Sanguisorbae. The whole prescription is reasonably compatible with the monarch, minister, assistant, and envoy, and plays the effects of clearing away heat and detoxification, drying dampness and relieving itching, dispelling wind and relieving itching, and strengthening the spleen and removing dampness. It is clinically used for eczema and dermatitis caused by dampness stagnation caused by damp heat and rheumatism, atopic dermatitis and other itchy / immune skin diseases, especially suitable for the acute and subacute stages of eczema, and is safe and effective for relieving itching and improving skin barrier.

[0027] (2) Pharmacological experiments show that the Chinese medicine external preparation of the present invention can treat the DNFB-induced atopic dermatitis mouse model, improve skin lesions, epidermal thickness, ear thickness, mast cell infiltration, spleen and lymph node enlargement, reduce the number of scratching times and SCORAD score, enhance the expression of epidermal barrier-related molecules, and reduce the expression of inflammatory factors.

[0028] ⑶. After years of clinical application verification, the name of the in-hospital preparation corresponding to the Chinese medicine external preparation of the present invention is: Antipruritic and Drying Ointment. The drug has completed clinical interventions for 10,910 patients with immune pruritic skin diseases such as eczema and atopic dermatitis. The Chinese medicine external preparation of the present invention has a more obvious therapeutic effect on patients with itchy skin diseases such as eczema and atopic dermatitis. Patients with mild symptoms can be cured within one course of treatment, while patients with severe symptoms or larger skin lesions require 2 courses of treatment to see significant effects or recovery. After 5 years of clinical practice verification (2020-2024), the Chinese medicine external preparation has shown significant therapeutic advantages, with a total effective rate of 92% and a cure rate of more than 85%. And it performs outstandingly in terms of treatment convenience and patient compliance.

[0029] The Chinese medicine external preparation has almost no side effects in clinical applications and has good safety. The Chinese medicine external preparation of the present invention can also effectively treat and improve the clinical symptoms of various pruritic / immune skin disease patients including folliculitis, neurodermatitis, and steroid dermatitis. In addition, the Chinese medicine external preparation of the present invention has the advantages of small side effects, simple preparation process and low cost. In summary, the Chinese medicine external preparation of the present invention has a very broad market application prospect and is worthy of further promotion in clinical practice. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The drawings described herein are used to provide a further understanding of the present invention and constitute a part of the present invention, wherein the Chinese medicine external preparation of the present invention refers to: a Chinese medicine external preparation made from Phellodendron chinense, Sophora flavescens, Cnidium monnieri, Atractylodes macrocephala, Atractylodes macrocephala, and Sanguisorba officinalis, including but not limited to gel, ointment, etc. The illustrative embodiments of the present invention and their descriptions are used to explain the present invention and do not constitute an improper limitation of the present invention.

[0031] Figure 1 -A is the skin lesion picture of each group of mice, Figure 1 B H&E staining of back lesions, and Figure 1 C Toluidine blue staining results, in which the control group used vaseline to apply on the back, the DNFB group used DNFB to apply on the back according to the specific implementation method described below, and the low-dose group used 25 mg / cm 2 Chinese medicine preparations, high-dose group used 50mg / cm 2 Chinese medicine preparations, hormone treatment group was treated with 0.1% hydrocortisone.

[0032] Figure 2 - Figure A shows the ear pictures of mice in each group, H&E staining results and quantitative statistics of epidermal thickness; Figures B and C show the spleen, spleen volume and weight changes, and axillary lymph node volume and weight changes of mice with DNFB atopic dermatitis treated with two doses of Chinese medicine preparations; Figure 3 - Figure A shows the changes in scratching; Figure B shows the SCORD score; Figures C, D, E, and F show the four detailed indicators of the SCORD score, including erythema / hemorrhage, crust / dryness, epidermal exfoliation / erosion, and edema; Figure 4 - is the relative expression level of inflammatory factor mRNA in the skin tissue of each group of mice; Figure 5 - Statistical data on the body weight of mice in each experimental group; Figure 6 - Toxicity test of the Chinese medicine for external use of the present invention, H&E staining of liver and kidney of each group of mice; Figure 7 - are the effect diagrams before and after clinical use of individual patients using the Chinese medicine external preparation of the present invention, wherein: Figure 7 A, male patient, 32 years old, suffered from dermatitis for 2 years with repeated attacks. Since using the product on August 7, 2023, the skin lesions subsided by 30% in 3 days, 50% in 7 days, and basically completely subsided in 14 days. Figure 7 B, a 73-year-old female patient, had suffered from eczema for 1 year. She started using the product on July 19, 2023, and her skin lesions improved significantly after 14 days of use. Figure 7 C, male patient, 4 years old, suffered from eczema for half a year. He started using the product on June 15, 2023. After 7 days of use, the skin lesions subsided by 50%, and after 14 days of use, the skin lesions were basically completely subsided. Figure 7 D, male patient, 4 years old, suffered from atopic dermatitis for 4 years. He started using the product on June 13, 2023, and the skin lesions subsided by 70% after 14 days of use. Figure 7 E, female patient, 3 years old, had urticaria pigmentosa for half a year. She started using the product on June 8, 2023. The itching was relieved after 7 days of use, and significantly relieved after 14 days of use.

[0033] Figure 8 - Effect diagram of skin recovery status before and after treatment of some patients using the topical ointment and gel of the present invention. DETAILED DESCRIPTION

[0034] In order to more fully understand the implementation of the present invention, one or more experimental examples are listed below, and the present invention is further described below through typical embodiments.

[0035] Example 1 Preparation of the TCM external preparation gel of the present invention Take the following dosage of the prescription of the present invention: 100g of Phellodendron chinense, 100g of Sophora flavescens, 100g of Cnidium monnieri, 100g of Atractylodes macrocephala, 100g of Atractylodes macrocephala, and 100g of Sanguisorba officinalis; The preparation method steps are as follows: Step 1: Prepare and cook the ingredients Take the raw materials according to the proportion and mix them thoroughly. Add 13 times the amount of water to the mixed raw materials and soak them for 1.5 hours. Decoction the soaked raw materials for 2 hours at the first decoction, and then filter and take the liquid. Add 11 times the amount of water to the remaining drug residue, decoct for another 1.5 hours, and filter and take the liquid. Combine the filtrates obtained from the two decoctions and let them settle.

[0036] Step 2: Concentration, drying and preparation The filtrate obtained in step 1 is concentrated under reduced pressure at 70°C to a relative density of 1.01-1.05, the concentrated solution is allowed to stand for 18 hours, and the supernatant is concentrated at 70°C to a clear paste solution with a relative density of 1.10-1.15.

[0037] Step 3: Prepare the gel Take 100g of glycerol and 30g of sodium carboxymethyl cellulose, mix them evenly. Stir them evenly, add 80mL of the clear paste liquid obtained in step 2- while stirring, and add an appropriate amount of distilled water until the total mass reaches 1000g. Then mix the above liquid and pharmaceutical excipients evenly, and the prepared Chinese medicine external gel is filled, sealed, and quality inspected.

[0038] Example 2 Preparation of the Traditional Chinese Medicine External Ointment of the Present Invention Take the following dosage of the prescription of the present invention: 100g of Phellodendron chinense, 100g of Sophora flavescens, 100g of Cnidium monnieri, 100g of Atractylodes macrocephala, 100g of Atractylodes macrocephala, and 100g of Sanguisorba officinalis; The preparation method steps are as follows: Step 1: Raw material preparation and cooking Take the raw materials according to the proportion and mix them thoroughly. Add 12 times the amount of water to the mixed raw materials and soak them for 2 hours. Decoction the soaked raw materials for 1.5 hours at the first decoction, and then filter and take the liquid. Add 10 times the amount of water to the remaining drug residue, decoct for another hour, and filter and take the liquid. Combine the filtrates obtained from the two decoctions and let them settle.

[0039] Step 2: Concentration, drying and preparation The filtrate obtained in step 1 is concentrated under reduced pressure at 60°C to a relative density of 1.01-1.05, the concentrated solution is allowed to stand for 12 hours, and the supernatant is concentrated at 80°C to a clear paste solution with a relative density of 1.10-1.15.

[0040] Step 3: Ointment preparation ①, Liquid A: Weigh 5g of Carbomer, add it into 300ml of distilled water, and stir it using a mechanical stirring device; ②, Liquid B: Take 1g of triethanolamine and 0.3g of ethylparaben and add them to 20ml of distilled water and stir with a stirrer until they are completely dissolved to form a uniform neutralizer solution; ③. Mix liquid A and liquid B and continue stirring until they are uniform.

[0041] Mix the clear ointment obtained in step 2 with the ointment base in step 3, and continue stirring until uniform. During the process, adjust the mixing amount according to the pH value of the solution. Add the neutralizer solution in small amounts and multiple times to avoid adding too much at one time; during the stirring process, constantly observe the viscosity and uniformity of the ointment, and the texture is uniform, and the ointment is prepared. Fill, seal, and conduct quality inspection.

[0042] Example 3 Preparation of the Chinese medicine external preparation spray of the present invention Take the following dosage of the prescription of the present invention: 100g of Phellodendron chinense, 100g of Sophora flavescens, 100g of Cnidium monnieri, 100g of Atractylodes macrocephala, 100g of Atractylodes macrocephala, and 100g of Sanguisorba officinalis; The preparation method steps are as follows: Step 1: Raw material preparation and cooking Take the raw materials according to the proportion and mix them thoroughly. Add 14 times the amount of water to the mixed raw materials and soak them for 1 hour. Decoction the soaked raw materials for 3 hours at the first decoction, and then filter and take the liquid. Add 12 times the amount of water to the remaining drug residue, decoct for another 2 hours, and filter and take the liquid. Combine the filtrates obtained from the two decoctions and let them settle.

[0043] Step 2: Concentration, drying and preparation The filtrate obtained in step 1 is concentrated under reduced pressure at 75°C to a relative density of 1.01-1.05, the concentrated solution is allowed to stand for 12 hours, filtered, and the supernatant is concentrated at 70°C to a clear paste solution with a relative density of 1.10-1.15.

[0044] The concentrated clear paste liquid is stirred evenly, and distilled water is added to 1000 ml to form a stable and uniform solution, which is made into a spray, filled, sealed, and quality inspected.

[0045] Example 4 Preparation of the Traditional Chinese Medicine External Preparation Solution Liniment of the Present Invention Take the following dosage of the prescription of the present invention: 100g of Phellodendron chinense, 100g of Sophora flavescens, 100g of Cnidium monnieri, 100g of Atractylodes macrocephala, 100g of Atractylodes macrocephala, and 100g of Sanguisorba officinalis; The preparation method steps are as follows: Step 1: Raw material preparation and cooking Take the raw materials according to the proportion and mix them thoroughly. Add 10 times the amount of water to the mixed raw materials and soak them for 1 hour. Decoction the soaked raw materials for 2 hours at the first decoction, and then filter and take the liquid. Add 8 times the amount of water to the remaining drug residue, decoct for another 1.5 hours, and filter and take the liquid. Combine the filtrates obtained from the two decoctions and let them settle.

[0046] Step 2: Concentration, drying and preparation The filtrate obtained in step 1 is concentrated under reduced pressure at 70°C to a relative density of 1.01-1.05, the concentrated solution is allowed to stand for 12 hours, and the supernatant is concentrated at 75°C to a clear paste solution with a relative density of 1.10-1.15.

[0047] Evenly stir the concentrated clear paste liquid, add distilled water to 1000ml to form a stable and uniform solution, prepare the solution ointment, fill, seal and conduct quality inspection.

[0048] Example 5 Preparation of the TCM external preparation gel of the present invention Take the following prescription dosage of the present invention: 110g of Phellodendron, 100g of Atractylodes, 100g of Atractylodes, 110g of Sophora flavescens, 100g of Cnidium monnieri, and 90g of Sanguisorba officinalis; prepare the traditional Chinese medicine gel according to the preparation method of Example 1.

[0049] Example 6 Preparation of the Chinese medicine external preparation ointment of the present invention Take the following prescription and dosage of the present invention: 100g of Phellodendron chinense, 90g of Sophora flavescens, 100g of Cnidium monnieri, 110g of Atractylodes macrocephala, 90g of Atractylodes macrocephala, and 100g of Sanguisorba officinalis; prepare a traditional Chinese medicine ointment according to the "Preparation method of Example 2".

[0050] Example 7 Preparation of the Chinese medicine external preparation spray of the present invention Take the following prescription dosage of the present invention: 90g of Phellodendron chinense, 110g of Sophora flavescens, 90g of Cnidium monnieri, 110g of Atractylodes macrocephala, 90g of Atractylodes macrocephala, and 110g of Sanguisorba officinalis; prepare a traditional Chinese medicine spray according to the "Preparation method of Example 3".

[0051] Example 8 Preparation of the Traditional Chinese Medicine External Preparation Solution Liniment of the Present Invention Take the following prescription and dosage of the present invention: 110g of Phellodendron, 90g of Sophora flavescens, 110g of Cnidium monnieri, 90g of Atractylodes macrocephala, 110g of Atractylodes macrocephala, and 90g of Sanguisorba officinalis; prepare a Chinese medicine liniment according to the "Preparation method of Example 8".

[0052] In order to further illustrate the safety and effectiveness of the Chinese medicine external preparation of the present invention in clinical practice, we have compiled some of the clinical and pharmacological experimental results of the present invention as follows to further illustrate the beneficial effects of the Chinese medicine external preparation of the present invention.

[0053] Experimental Example 1 Observation on the clinical therapeutic effect of the Chinese medicine external preparation of the present invention on patients with different dermatitis and eczema 1.1 General Information A total of 1000 outpatients with dermatitis and eczema of damp-heat accumulation in the skin, damp-heat infiltration, and spleen deficiency and dampness accumulation type who met the clinical standard requirements were collected (The First Affiliated Hospital of Xi'an Jiaotong University). The general data of the selected patients, such as age (3-80 years old), disease course (3 days to 2 years), and disease severity, were compared, and there was no statistically significant difference (P>0.05), so they were comparable.

[0054] 1.2 Diagnostic criteria 1.2.1 Standards for TCM Syndrome Differentiation TCM syndrome diagnostic criteria (developed with reference to the "Syndrome Section of TCM Clinical Diagnosis and Treatment Terminology" GB / T16751.2-1997 and the "Guidelines for Clinical Research of New Chinese Medicines" 2002).

[0055] 1.2.1.1 Damp-heat accumulation in the skin syndrome Main symptoms: skin blisters or redness, swelling, erosion, discharge, scabs, and infiltration of skin and mucous membranes. Itching of the affected area. Red tongue with yellow and greasy tongue coating and slippery and rapid pulse.

[0056] 1.2.1.2 Syndrome of damp-heat infiltration Main symptoms: redness, swelling, wetness and rottenness of the eyelid margins or ear canals, nasal cavity, corners of mouth, fingers, toes, etc., ulceration and discharge, severe itching, or eyelid swelling, extending to the whole body, red tongue, thin and greasy or yellow tongue coating, slippery and rapid pulse. Secondary symptoms: aversion to wind, fever, sore throat.

[0057] 1.2.1.3 Spleen deficiency and dampness accumulation syndrome Main symptoms: poor appetite, abdominal distension, loose stools, yellow urine, heaviness in the head and body, excessive leucorrhea, pale tongue, thin white or greasy tongue coating, soft or smooth pulse. Secondary symptoms: eczema, herpes, genital sores, dark spots.

[0058] 1.3 Inclusion criteria Meet the above diagnostic criteria.

[0059] 1.4 Exclusion criteria 1) Those who have used other drugs to treat the disease after the onset of the disease; 2) Those who did not use the drugs as prescribed and whose efficacy cannot be determined, or whose data are incomplete and whose efficacy cannot be determined. 3) Those who have severe primary cardiovascular disease, liver disease, kidney disease, hematological disease, lung disease, or serious diseases that affect their survival, such as tumors or AIDS.

[0060] 1.5 Treatment Dosage and administration: Apply the ointment prepared by the method of Example 2 of the present invention to the skin lesions of the test patients 3 times a day for 14 consecutive days. During the medication period, the skin lesions should be rinsed less and rest should be taken.

[0061] 1.6 Efficacy evaluation criteria Cured: The lesion area decreased by more than 70%, and the itching almost disappeared. Improved: The lesion area decreased by more than 50%, and the itching was significantly improved. Ineffective: The lesion area decreased by less than 30%, and the itching was not significantly relieved.

[0062] 1.7 Treatment outcomes Clinical efficacy statistics: Patients used the Chinese medicine compound ointment preparation of the present invention for external use, applied to the affected skin lesions, once in the morning and evening, and 7 days was a course of treatment. All cases had symptoms such as erythema and itching. This study observed the erythema area and itching degree of 1,000 patients with dermatitis and eczema 7 days and 14 days after medication. The clinical efficacy results are shown in Table 1.

[0063] Table 1 Clinical efficacy statistics of the Chinese medicine external ointment preparation of the present invention Number of cases (N) Improvement rate (%) Cure rate (%) Inefficiency (%) 1000 (example) 920（92%） 850（85%） 80（8%） The clinical observation results shown in Table 1 show that the total effective rate of the Chinese medicine ointment preparation of the present invention in treating erythema, itching and exudation symptoms of dermatitis and eczema is 92%, the cure rate can reach 80%, and the itching symptoms of most patients can be relieved within 7 days.

[0064] 1.8 Adverse Reactions The Chinese medicinal ointment preparation for external use of the present invention did not show any adverse reactions during clinical treatment observation. The above clinical statistical results show that the Chinese medicinal ointment preparation for external use of the present invention has significant clinical efficacy in treating dermatitis and eczema, and is safe and convenient to use, and is worthy of active promotion and application in clinical practice.

[0065] Experimental Example 2 Therapeutic effect of Chinese medicine external preparation on hapten (DNFB) AD mouse model 1. Improvement of skin lesions, itching symptoms and tissue pathology of AD mice by external Chinese medicine preparations 1. Experimental materials and methods: 1.1 Preparation of test drugs: A. Preparation of the drug group of the present invention: (1) Take 10g of Phellodendron amurense, 10g of Sophora flavescens, 10g of Cnidium monnieri, 10g of Atractylodes macrocephala, 10g of Atractylodes macrocephala, and 10g of Radix Sanguisorbae officinalis, and mix them thoroughly.

[0066] (2) Add 12 to 14 times the amount of water to the mixed API and soak for 1 to 2 hours.

[0067] (3) Decoction the soaked raw materials for 1.5 to 3 hours at the first decoction, and then filter the liquid.

[0068] (4) Add 10 to 12 times the amount of water to the remaining residue, boil for 1 to 2 hours, and filter the liquid.

[0069] (5) Combine the filtrates obtained from the two decoctions and let them stand to settle.

[0070] (6) Concentrate the filtrate under reduced pressure at 60°C-85°C to a relative density of 1.01-1.05.

[0071] (7) Let the concentrated solution stand for 12 to 24 hours, take the supernatant and concentrate it at 60 to 85°C to a relative density of 1.10-1.15. Set aside.

[0072] (8) Take 100 g of glycerol and 30 g of sodium carboxymethyl cellulose and mix them evenly.

[0073] (9) Stir the two mixtures evenly and add 80 mL of the solution obtained in step (7) while stirring. At the same time, add an appropriate amount of distilled water until the total mass reaches 1000 g.

[0074] (10) The above-mentioned drug solutions are mixed evenly, and the prepared gel is filled and sealed to obtain the product.

[0075] B. Preparation of control group drugs: Take 1% hydrocortisone cream sold on the market.

[0076] 1.2 Experimental animals: 30 6-week-old Balb / c mice were purchased from the Animal Center of Xi'an Jiaotong University.

[0077] Statistical analysis: The experimental results were ±s indicates that the significance of the difference among the groups was determined by t test.

[0078] 2. Pharmacological and efficacy tests and results of the present invention: 2.1 Improvement of skin lesions, pruritus and histopathology of AD mice by topical Chinese medicine Thirty 6-week-old Balb / c mice were randomly divided into 5 groups, with 6 mice in each group. Group 1: blank control group (negative control group); Group 2: model group (DNFB group); Group 3: low-dose treatment group (25 mg / cm2); Group 4: high-dose treatment group (50 mg / cm 2 ); Group 5: Hydrocortisone application group. Chinese medicine formula: 10 parts of raw Sanguisorba officinalis, 10 parts of Phellodendron chinense, 10 parts of bran-fried Atractylodes macrocephala, 10 parts of bran-fried Atractylodes macrocephala, 10 parts of Sophora flavescens, and 15 parts of Cnidium monnieri. Low-dose thin application (25 mg / cm 2 ), high dose thick coating (50mg / cm 2). On the first two days of the first week, 100ul 1% high concentration DNFB was applied to the back of the mice for sensitization. The solvent was acetone / olive oil = 3 / 1. On the 1st and 4th days of the second week, 100ul 0.4% low concentration DNFB was applied to the back of the mice to maintain sensitization. On the 1st and 4th days of the third and fourth weeks, groups 2-5 continued to use 100ul 0.4% low concentration DNFB to maintain sensitization. At the same time, groups 3-5 were treated every day in the third and fourth weeks for 14 consecutive days. Among them, group 3 was given 25mg / cm 2， The Chinese medicine external preparation of the present invention was evenly applied to the back, once a day; Group 4 was given 50 mg / cm 2 The Chinese medicine external preparation was evenly applied on the back, once a day; Group 5 used 100ul, 1% hydrocortisone, once a day, and the back skin of the mice was photographed after hair removal and before and after treatment.

[0079] After the treatment, the mice were killed by cervical dislocation, and tissues from the back and ears of the mice were collected. The spleen and lymph nodes of the mice were photographed and weighed.

[0080] Mouse skin lesion severity score (SCORAD score): erythema / hemorrhage, scab / dryness, epidermal exfoliation / erosion, edema, the severity of each item is still scored from 0 to 3 points, 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score is the SCORAD score. Take pictures and calculate the SCORAD score of the mouse.

[0081] The specimens obtained during the experiment were thoroughly rinsed with saline to remove blood and contaminants, and then the tissue blocks were placed in 4% paraformaldehyde and fixed for 24 hours. They were then paraffin-embedded and sectioned, and H&E and toluidine blue stained, and image acquisition and analysis were completed using a microscope.

[0082] Results Figure 1 . Figure 1 A shows the changes in skin lesions on the back of mice. The results showed that on the 21st day, the skin lesions in the low-dose and high-dose Chinese herbal medicine treatment groups and the hormone treatment group were improved compared with the DNFB group. On the 28th day, the skin lesions in the Chinese herbal medicine treatment group were further improved, while the skin lesions in the hormone treatment group were aggravated. Figure 1 B shows the HE staining results of mouse skin tissue, which showed that the epidermal thickness increased in the DNFB group, and after low-dose and high-dose Chinese herbal topical preparations and hormone treatment, the epidermal thickness decreased significantly. Figure 1 C shows the results of toluidine blue staining of mouse skin tissue, and the results show that the number of mast cells in the Chinese medicine topical preparation treatment group and the hormone treatment group decreased compared with the DNFB group. The above all indicate that Chinese medicine topical preparations have a significant therapeutic effect on the DNFB-induced mouse atopic dermatitis model.

[0083] Figure 2 A shows the HE staining results of mouse ear tissue, which showed that the ear thickness increased in the DNFB group, and after low-dose and high-dose Chinese medicine treatments and hormone treatment, the ear thickness decreased significantly. Figure 2 B shows the size and weight of mouse spleen. Figure 2 C shows the size and weight of the mouse axillary lymph nodes. The results show that the spleen and lymph nodes in the DNFB group were significantly enlarged, and the mass of the spleen and lymph nodes decreased after low-dose and high-dose Chinese medicine combinations and hormone treatment. It shows that Chinese medicine topical preparations can improve the enlargement of the spleen and lymph nodes in the DNFB-induced mouse atopic dermatitis model. In addition, the mass of the spleen and lymph nodes in the hormone treatment group decreased, indicating a significant inhibitory effect on the immune organs, and the Chinese medicine topical preparation of the present invention has good safety.

[0084] Figure 3 A shows the changes in the number of scratching times in mice. The results indicate that topical Chinese medicine preparations and hormone treatment can effectively improve the itching caused by DNFB-induced atopic dermatitis. Figure 3 BF shows the total SCORAD score of mice and four SCORAD indicators: erythema / hemorrhage, dry scab, epidermal exfoliation / erosion, and edema. The results showed that compared with the DNFB group, the total SCORAD score and various indicators of the Chinese medicine topical preparation treatment group decreased.

[0085] 2.2 Effects of external Chinese medicine preparations on the expression of inflammatory factors in the skin of AD mice Total RNA was extracted from mouse skin tissue, and reverse transcription and real-time quantitative PCR (qRT-PCR) were performed to determine the relative expression of related inflammatory factors. Figure 4 ,in Figure 4 A is the relative expression of FLG (filagrin). The expression of FLG increased after treatment with topical Chinese medicine and hormone therapy, indicating that topical Chinese medicine and hormone therapy have a certain effect on epidermal barrier repair. Figure 4 BF is the relative expression of IL-4, IL-6, IL-22, IL-23, and TNFα, which was significantly increased in DNFB mice and decreased in the Chinese herbal topical preparations and hormone treatment groups, indicating that Chinese herbal topical preparations can reduce the expression of inflammatory factors in the DNFB-induced atopic dermatitis mouse model.

[0086] 2.3 Safety experiments of Chinese medicine external preparations The weight of mice was monitored and recorded weekly during the experiment. After the treatment, the specimens (liver and kidney tissues) obtained during the experiment were thoroughly rinsed with saline to remove blood and contaminants, and then the tissue blocks were placed in 4% paraformaldehyde and fixed for 24 hours. Paraffin embedding and tissue sectioning were then performed, H&E staining was performed, and image acquisition and analysis were completed using a microscope.

[0087] Results Figure 5-6 ,in Figure 5 Shows the changes in mouse body weight. Figure 6 The H&E staining results of the liver and kidney tissues of mice are shown. The results show that during the treatment, the mice in the Chinese herbal medicine treatment group were in general good condition, ate normally, and had no significant weight loss. H&E staining showed that there were no obvious histological abnormalities in the liver and kidneys of mice in each group, indicating that the Chinese herbal medicine at this dose had no hepato-renal toxicity to mice.

[0088] The above data show that the Chinese medicine external preparation of the present invention has very high safety.

[0089] In order to further highlight the significant clinical efficacy of the external Chinese medicine preparation for external use of the present invention, the effects of the external preparation of the present invention on some patients are selected for further explanation, and the results are organized as follows.

[0090] Typical cases: Case 1, Peng, male, 32 years old, chief complaint: the patient had erythema, papules and itching all over the body for 2 years, which worsened for 1 month. Current medical history: the patient complained that erythema and papules appeared on the skin all over the body without obvious causes 2 years ago, and he felt itchy and recurrent. One month ago, the skin lesions expanded without obvious causes, and he felt that the itching worsened. There was no dry mouth or bitter taste in the mouth, and his appetite and sleep were good, and his bowel movements were normal. TCM symptoms: pale tongue, fat white thick fur, and floating pulse.

[0091] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Rhizoma Atractylodis Macrocephalae 10g, Rhizoma Atractylodis Macrocephalae 10g, Radix Sanguisorbae 10g. Usage: Apply the ointment prepared above to the lesions 3 times a day for 14 consecutive days. The patient has been using this product since August 7, 2023. After 3 days of medication, the lesions subsided by 30% and the itching was alleviated; after 7 days of medication, the lesions subsided by 50% and the itching was significantly improved; after 14 days of medication, the lesions were basically completely subsided.

[0092] Case 2, Li, female, 74 years old, main complaint: erythema, scaling, erosion, exudation and itching on the skin of both lower limbs for 1 year, aggravated for 2 months. Current medical history: The patient complained that erythema and scaling appeared on the skin of both lower limbs without obvious cause 1 year ago, and she felt itchy and recurrent. Two months ago, there was no obvious cause, the skin lesions worsened, the exudation increased, and the itching was obvious. There was no dry mouth or bitter taste in the mouth, the appetite and sleep were good, and the bowel movements were normal. TCM symptoms: pale tongue with thick white fur, slippery and rapid pulse.

[0093] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Rhizoma Atractylodis Macrocephalae 10g, Rhizoma Atractylodis Macrocephalae 10g, Radix Sanguisorbae 10g. Usage: Apply the ointment made of the above drugs to the lesions 3 times a day for 14 consecutive days. The patient has been using the product since July 19, 2023. After 14 days of use, the exudation of the lesions was significantly reduced, the itching was relieved, and the area of ​​the lesions was reduced.

[0094] Case 3, Yang Moumou, male, 4 years and 3 months old, main complaint: erythema, papules and itching on the skin of both upper limbs for half a year. Current medical history: The patient complained that there were erythema and papules on the skin of both upper limbs without obvious cause half a year ago, and he felt itchy and recurrent attacks, without dry mouth and bitter taste in the mouth, and his appetite and sleep were good, and his bowel movements were normal. TCM symptoms: red tongue with thin white fur, floating pulse.

[0095] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Atractylodes macrocephala 10g, Atractylodes macrocephala 10g, Sanguisorba officinalis 10g. Usage: Apply the ointment made of the above drugs to the lesions, 3 times a day, for 14 consecutive days. The patient has been using this product since June 15, 2023. After 7 days of use, the lesions subsided by 50% and the itching was relieved; after 14 days of use, the lesions were basically completely subsided.

[0096] Case 4, Liu, male, 5 years and 7 months old, main complaint: erythema and itching on the flexor side of the limbs for 4 years. Current medical history: The patient complained that erythema appeared on the flexor side of the limbs 4 years ago without obvious cause, and he felt itchy and recurrent. No dry mouth or bitter taste in the mouth, good appetite and sleep, normal bowel movements. TCM symptoms: pale red tongue, thin white fur, floating pulse.

[0097] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Rhizoma Atractylodis Macrocephalae 10g, Rhizoma Atractylodis Macrocephalae 10g, Radix Sanguisorbae 10g. Usage: Apply the ointment prepared from the above drugs to the lesions 3 times a day for 14 consecutive days. The patient has been using the product since June 13, 2023. After 14 days of use, the lesions subsided by 70% and the itching was significantly improved.

[0098] Case 5, Wang Moumou, female, 4 years and 6 months old, main complaint: dark red papules and plaques with itching on the skin of the trunk and limbs for half a year. Current medical history: The patient complained that dark red papules and plaques appeared on the skin of the trunk and limbs without obvious causes half a year ago, and she felt itchy and recurrent attacks, but no treatment was given. No dry mouth or bitter taste in the mouth, good appetite and sleep, normal bowel movements. TCM symptoms: pale red tongue, thick white fur, slow pulse.

[0099] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Rhizoma Atractylodis Macrocephalae 10g, Rhizoma Atractylodis Macrocephalae 10g, Radix Sanguisorbae 10g. Usage: Apply the ointment prepared from the above drugs to the lesions 3 times a day for 14 consecutive days. The patient has been using this product since June 8, 2023. The itching degree has been reduced after 7 days of use, and the itching degree has been significantly reduced after 14 days of use.

[0100] Case 6, Guo, male, 69 years old, main complaint: erythema, papules, plaques and itching on both lower limbs for 1 month. Current medical history: The patient complained that erythema and papules appeared on both lower limbs without obvious cause 1 month ago, the area of ​​lesions gradually expanded, and he felt itchy, but no treatment was given. No dry mouth or bitter taste in the mouth, good appetite and sleep, normal bowel movements. TCM symptoms: red tongue, thick white fur, floating and fine pulse.

[0101] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Atractylodes macrocephala 10g, Atractylodes macrocephala 10g, Sanguisorba officinalis 10g. Usage: Apply the ointment prepared from the above drugs to the skin lesions, 3 times a day, for 14 consecutive days.

[0102] The patient started using the product on February 9, 2023. After 11 days of use, the skin lesions subsided by 50% and the itching was alleviated. After 14 days of use, the skin lesions subsided by 70% and the itching was significantly improved.

[0103] Case 7, Zhang, male, 23 years old, main complaint: erythema and itching on the back of the neck for 1 week. Current medical history: The patient complained that erythema appeared on the left side of the back of the neck without obvious cause 1 week ago, and he felt itchy and recurrent attacks, but no treatment was given. No dry mouth or bitter taste in the mouth, good appetite and sleep, normal bowel movements. TCM symptoms: pale tongue, thick white fur, deep and fine pulse.

[0104] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Atractylodes macrocephala 10g, Atractylodes macrocephala 10g, Sanguisorba officinalis 10g. Usage: Apply the ointment prepared from the above drugs to the skin lesions, 3 times a day, for 7 consecutive days.

[0105] The patient started using the product on July 6, 2023. After 7 days of use, the itching disappeared and the skin lesions subsided by 90%.

[0106] Case 8, Zhang, male, 32 years old, main complaint: erythema, scaling and itching on both elbows and trunk for 2 months. Current medical history: The patient complained that erythema, papules and scaling appeared on both elbows and trunk skin without obvious cause 2 months ago, and he felt itchy and recurrent attacks, but he was not treated. No dry mouth or bitter taste in the mouth, good appetite and sleep, normal bowel movements. TCM symptoms: red tongue, thick white fur with cracks, deep and strong pulse.

[0107] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Atractylodes macrocephala 10g, Atractylodes macrocephala 10g, Sanguisorba officinalis 10g. Usage: Apply the ointment prepared from the above drugs to the skin lesions, 3 times a day, for 7 consecutive days.

[0108] The patient started using the product on June 20, 2023. After 7 days of use, the itching improved and the skin lesions subsided by 50%.

[0109] Case 9, Liu, female, 59 years old, main complaint: Symmetrical purpura, scaling, erythema and itching on the skin of the patient's limbs for 2 years. Current medical history: 2 years ago, dark red purpura, erythema and scaling appeared on the skin of the limbs without obvious cause, and itching occurred repeatedly. No dry mouth or bitter taste in the mouth, good appetite and sleep, normal bowel movements. TCM symptoms: red tongue, thick white fur with cracks, and smooth pulse.

[0110] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Atractylodes macrocephala 10g, Atractylodes macrocephala 10g, Sanguisorba officinalis 10g. Usage: Apply the ointment prepared from the above drugs to the skin lesions, 3 times a day, for 14 consecutive days.

[0111] The patient started using the product on July 27, 2023. After 14 days of use, the itching improved and the skin lesions subsided by 50%.

[0112] Case 10, He Moumou, female, 53 years old, chief complaint: the patient had skin erythema, papules, exudation and itching on both upper limbs for 2 months. Current medical history: 2 months ago, there was no obvious cause for erythema, papules, exudation on both upper limbs, and itching. She had been treated in Yulin Second Hospital, and external calamine lotion, fluticasone propionate cream, oral prednisone acetate tablets, Shufeng Jiedu capsules, and rupatadine fumarate tablets were used for treatment, but the effect was not good, the skin lesions did not show significant improvement, and the skin lesions still recurred. There was no dry mouth or bitter taste in the mouth, appetite and sleep were good, and bowel movements were normal. TCM symptoms: red tongue, white and greasy fur, and soft pulse.

[0113] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Atractylodes macrocephala 10g, Atractylodes macrocephala 10g, Sanguisorba officinalis 10g. Usage: Apply the ointment made of the above drugs to the skin lesions 3 times a day for 7 consecutive days. The patient has been using this product since July 27, 2023. After 7 days of use, the itching improved and the skin lesions subsided by 50%.

[0114] Case 11, Ma Moumou, male, 26 years old, Chief complaint: The patient had wheals and itching all over the skin for 1 year. Current medical history: wheals and itching appeared on the skin all over the body without obvious causes 1 year ago. He had taken fexofenadine tablets orally, but the effect was poor and the symptoms recurred. No dry mouth or bitter taste in the mouth, good appetite and sleep, normal bowel movements. TCM symptoms: red tongue, yellow fur, floating pulse.

[0115] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Atractylodes macrocephala 10g, Atractylodes macrocephala 10g, Sanguisorba officinalis 10g. Usage: Apply the ointment prepared from the above drugs to the skin lesions, 3 times a day, for 1 month.

[0116] The patient started using the product on May 12, 2023. After 14 days of use, the itching improved and the skin lesions subsided by 50%. After one month of use, the skin lesions subsided by 70% and the itching improved significantly.

[0117] Case 12, Ding, female, 33 years old, main complaint: the patient had erythema, papules, plaques and itching on the whole body skin for 2 years. Current medical history: 2 years ago, there was no obvious cause and erythema, papules, plaques and itching appeared on the whole body skin. Desonide cream was used externally, but the effect was poor and the symptoms recurred. No dry mouth or bitter taste in the mouth, good appetite and sleep, normal bowel movements. TCM symptoms: red tongue, white and greasy fur, floating pulse.

[0118] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Atractylodes macrocephala 10g, Atractylodes macrocephala 10g, Sanguisorba officinalis 10g. Usage: Apply the ointment prepared from the above drugs to the skin lesions, 3 times a day, for 7 consecutive days.

[0119] The patient started using the product on September 8, 2022. After 7 days of use, the itching improved and the skin lesions subsided by 50%.

[0120] Case 13, Liu, male, 79 years old, main complaint: the patient had erythema, papules and itching on the whole body of the skin for 2 years. Current medical history: 2 years ago, there was no obvious cause for erythema, papules and plaques on the whole body of the skin, and he felt itchy. He was diagnosed with "eczema" in another hospital and treated with topical hormone ointment, but the effect was poor and the disease recurred. There was no dry mouth or bitter taste in the mouth, and the appetite and sleep were good, and the bowel movements were normal. TCM symptoms: red tongue, thin white fur, floating pulse, strong pulse when pressed hard.

[0121] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Atractylodes macrocephala 10g, Atractylodes macrocephala 10g, Sanguisorba officinalis 10g. Usage: Apply the ointment prepared from the above drugs to the skin lesions, 3 times a day, for 14 consecutive days.

[0122] The patient started using the product on August 29, 2024. The itching improved after 7 days of use, and the skin lesions subsided by 50% after 14 days of use.

[0123] Case 14, Song Moumou, female, 52 years old, main complaint: erythematous papules and itching on the whole body skin for 4 days. Current medical history: The patient complained that erythema and papules appeared on the whole body skin after eating dried shrimps 4 days ago, and she felt itchy and recurrent attacks, but no treatment was given. There was dry mouth, no bitter taste in the mouth, good appetite and sleep, and normal bowel movements. TCM symptoms: red tongue, white and greasy coating, and floating pulse.

[0124] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Atractylodes macrocephala 10g, Atractylodes macrocephala 10g, Sanguisorba officinalis 10g. Usage: Apply the ointment prepared from the above drugs to the skin lesions, 3 times a day, for 7 consecutive days.

[0125] The patient started using the product on July 15, 2024. After 7 days of use, the itching improved and the skin lesions subsided by 50%.

[0126] Case 15, Zhang, female, 3 years and 11 months old, main complaint: erythema, papules and itching on the limbs and face for 1 week. Current medical history: The patient complained that erythema and papules appeared on the limbs and face without obvious cause 1 week ago, and she felt itchy, but no treatment was given. She had dry mouth and bad breath, liked to eat cold food, had good appetite and sleep, and had normal bowel movements. TCM symptoms: red tongue, thin white fur, and floating pulse.

[0127] Prescription: Phellodendron chinense 10g, Sophora flavescens 10g, Cnidium monnieri 10g, Atractylodes macrocephala 10g, Atractylodes macrocephala 10g, Sanguisorba officinalis 10g. Usage: Apply the ointment prepared from the above drugs to the skin lesions, 3 times a day, for 14 consecutive days.

[0128] The patient has been using this product since March 25, 2024. After 14 days of use, the itching improved and the skin lesions subsided by up to 50%.

Claims

1. A Chinese medicinal external preparation for treating pruritic skin diseases, characterized in that: The traditional Chinese medicine external preparation comprises raw materials in the following weight proportions: 9-11 parts of Phellodendron amurense, 9-11 parts of Sophora flavescens, 9-11 parts of Cnidium monnieri, 9-11 parts of Atractylodes macrocephala, 9-11 parts of Atractylodes macrocephala, and 9-11 parts of Sanguisorba officinalis.

2. The Chinese medicinal external preparation for treating pruritic skin diseases according to claim 1, characterized in that: The traditional Chinese medicine external preparation comprises raw materials in the following weight proportions: 10 parts of Phellodendron amurense, 10 parts of Sophora flavescens, 10 parts of Cnidium monnieri, 10 parts of Atractylodes lancea, 10 parts of Atractylodes macrocephala, and 10 parts of Sanguisorba officinalis.

3. The method for preparing the Chinese medicine external preparation according to claim 1 or 2, characterized in that: The preparation method comprises the following steps: Step (1): taking the medicinal materials of Phellodendron chinense, Sophora flavescens, Cnidium monnieri, Atractylodes lancea, Atractylodes macrocephala, and Sanguisorba officinalis in the weight ratio, soaking them in water, adding 8 to 14 times the weight of the above medicinal materials in water, decocting them 1 to 3 times for 0.5 to 3 hours, filtering, and combining the above decoction filtrates; Step ⑵: Take the decocted filtrate of step ⑴, and concentrate it under reduced pressure at 65-85° C. to a clear paste with a relative density of 1.10-1.

15. After concentration, add the clear paste liquid, and then add the pharmaceutical excipients, stir and mix evenly to prepare a Chinese medicine external preparation.

4. The method for preparing the Chinese medicine external preparation as claimed in claim 3, characterized in that: The preparation method comprises the following steps (1): Take the medicinal materials of Phellodendron chinense, Sophora flavescens, Cnidium monnieri, Atractylodes lancea, Atractylodes macrocephala, and Sanguisorba officinalis in the above weight ratio, add 12 to 14 times the weight of the above medicinal materials in water, soak in water for 1 to 2 hours, decoct in water twice, the first decoction time is 1.5 to 3 hours, the second decoction time is 10 to 12 times the weight of the above medicinal materials in water, the second decoction time is 1 to 2 hours, filter, and combine the above decoction filtrates.

5. The method for preparing the Chinese medicine external preparation as claimed in claim 3, characterized in that: The concentration temperature in step (2) of the preparation method is 70°C.

6. The method for preparing the Chinese medicine external preparation as claimed in claim 3, characterized in that: The pharmaceutical excipients in step (2) of the preparation method are: one or more combinations of carbomer, triethanolamine, glycerol, and sodium carboxymethyl cellulose.

7. The method for preparing the Chinese medicine external preparation as claimed in claim 4, characterized in that: The dosage form of the traditional Chinese medicine external preparation can be: ointment, gel, liniment, spray, paste.

8. Use of the Chinese medicinal external preparation according to claim 1 or 2 in the preparation of drugs for treating immune skin diseases.

9. Use of the Chinese medicinal preparation for external use as claimed in claim 1 in preparing medicines for treating eczema and dermatitis.

10. Use of the Chinese medicinal external preparation according to claim 9 in preparing medicines for treating atopic dermatitis, folliculitis, neurodermatitis and steroid-induced dermatitis.

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