Traditional Chinese medicine external preparation for dispelling wind and arresting itching and application thereof

Abstract

The invention belongs to the field of traditional Chinese medicine preparations, and particularly relates to a traditional Chinese medicine external preparation for dispelling wind and arresting itching and application thereof. The traditional Chinese medicine external preparation is prepared from the following raw materials: 10-30 parts of fried fructus xanthii, 10-30 parts of fructus kochiae, 10-30 parts of rhizoma chuanxiong, 10-30 parts of flos carthami and 5-15 parts of solanum lyratum thunb. The raw materials are subjected to process extraction and refining to obtain the traditional Chinese medicine external preparation. A plurality of processes are researched, and research results show that the itching relieving and detumescence effects of the transdermal drug delivery preparation are obviously superior to those of original oral granules, and the effect is better than that of dermatitis treatment cream sold in the market. According to the traditional Chinese medicine external preparation disclosed by the invention, the anti-inflammatory, detumescence and itching-relieving drug effects are improved, oral administration is changed into external administration, the administration is more direct, the safety is higher, the drug effects are better, the crude drug amount is smaller, and the cost is lower.

Description

[0001] This invention is a divisional application:

[0002] Parent case application number: 202410366266.1

[0003] Invention name of the parent case: A Chinese medicine external preparation for dispelling wind and relieving itching and its application

[0004] Parent case filing date: March 28, 2024 Technical Field

[0005] The invention belongs to the technical field of external preparations, and particularly relates to an external Chinese medicine preparation for dispelling wind and relieving itching and an application thereof. Background Art

[0006] Urticaria is a vascular skin reaction, typically manifested as a short-lived outbreak of itchy blisters. The blisters are erythematous spots with clear borders, pale centers, smooth, and slightly elevated skin surfaces, and they vary in shape and size. This reaction is caused by the release of other vasoactive substances caused by local histamine or hypersensitivity reactions. Acute urticaria develops rapidly and usually has a clear cause, such as hypersensitivity to certain drugs, foods, insect bites, vacuum cleaners, or contact allergens, emotional stress, or environmental factors. Although individual lesions may disappear within 12 to 24 hours, new lesions will continue to appear, and severe cases may be accompanied by anaphylactic shock-like symptoms such as palpitations, irritability, nausea, vomiting, and even low blood pressure. Urticaria that lasts for more than 6 weeks is chronic. It can recur over months or years, and the underlying cause is usually unknown. Sometimes, psychological factors can also cause urticaria. At present, general treatments include finding the cause and removing it, internal medication, or external use of calamine lotion or other antipruritic creams, such as diphenhydramine cream and hydrocortisone cream.

[0007] Eczema is also a relatively common skin disease caused by a variety of internal and external factors. It is characterized by severe itching and inflammatory reactions in the epidermis and superficial dermis. It is divided into three stages: acute, subacute, and chronic. The etiology of eczema is complex. It is easy to relapse after treatment and is difficult to cure. The clinical morphology and location are different, and the medication varies from person to person.

[0008] Itch is a symptom that is difficult to bear, but it persists. It seriously affects the quality of life. Oral antiallergic drugs are often used clinically. However, for chronic diseases, oral administration for a long time is prone to tolerance and adverse reactions. External antipruritic preparations have become another good treatment method. For refractory patients, hormone drugs are mainly used, such as potent hormone drugs such as compound flumethasone ointment and fluticasone propionate ointment; medium-acting hormone drugs include desonide ointment and mometasone furoate ointment. Weak hormone drugs are mainly hydrocortisone ointment. In addition, some traditional Chinese medicine ingredients such as paeonol ointment and Qingpeng ointment also have anti-inflammatory and antipruritic effects, but for those with severe symptoms and longer illness time, the effect is not obvious and cannot solve the actual clinical problems. Immunosuppressive drugs, such as tacrolimus and pimecrolimus, have obvious antipruritic effects while anti-inflammatory, but long-term use has obvious adverse reactions. Moisturizing ointments, such as zinc oxide ointment and vitamin E cream, can moisturize the skin and relieve itching, and can serve as an auxiliary treatment. Antipruritic ointments or lotions, such as halcinonide solution, calamine lotion, and compound triamcinolone acetate solution, can also play a good role, but if you want to have a good effect, they are also hormone-like ingredients and are not suitable for long-term use.

[0009] Compared with the traditional oral route, Chinese medicine for external use is simple, convenient, effective and cheap. Wu Shangxian, the "master of external treatment" in the Qing Dynasty, pointed out in "Lihua Pianwen" that "internal treatment with decoctions is like being in a dark room, and external treatment with plasters is like being in a public place. People in a dark room cannot see it, but people in a public place can see it. Therefore, internal treatment can be deceived, but external treatment cannot be deceived. However, it is easy to make up for mistakes and avoid serious mistakes. "In the Chinese Medicine Dictionary, some Chinese medicinal materials can be used externally to treat diseases, such as injuries, sores, carbuncles, and swellings, but most of them are fresh products, and fresh products are not specifically developed into Chinese patent medicines. Recently, many researchers have also made various efforts to study external preparations for itching.

[0010] Chinese patent application CN201310010283.3 discloses a Chinese medicine antipruritic gel and a preparation method, which is prepared from Viola yedoensis, Dictamni cortex and Sophora flavescens in a mass ratio of 2:1:1. The invention also relates to a preparation method of the Chinese medicine antipruritic gel, including (1) preparing a decoction concentrate of the Chinese medicine composition, (2) preparing a gel matrix, and (3) finally adding the decoction concentrate of the antipruritic Chinese medicine composition to the gel matrix, stirring evenly, and cooling at low temperature. In the above method, the gel excipients are 12-14 parts of hydroxyethyl cellulose, 5-8 parts of Avicel CL-611, 100 parts of glycerol, 50 parts of anhydrous ethanol, 15 parts of azone, 300-400 parts of distilled water, and 0-3 parts of carrageenan and 0-10 parts of sodium hydroxide. The Chinese medicine antipruritic gel of the invention is used in medicines for skin itching caused by various reasons, including eczema, urticaria and pruritus.

[0011] Chinese patent application CN201710188238.5 discloses a skin soothing and antipruritic gel and its preparation method. The invention uses Dendrobium officinale extract and carboxymethyl deacetylated chitosan as the main effective substances, and reasonably matches with thickeners, moisturizers, solubilizers, etc. to prepare a gel with skin soothing, antipruritic and moisturizing effects, which can effectively improve skin sensitivity, especially with immediate soothing and antipruritic effects. Chinese patent application CN201710189612.3 discloses a gel composition. The invention relates to a gel composition for relieving itching, which is made of pure natural plant extracts. The gel composition comprises the following raw materials in parts by weight: 0.1-2 parts of purslane extract, 0.1-2 parts of white chamomile extract, 0.1-2 parts of licorice extract, 0.1-2 parts of neem extract, 0.5-4 parts of carbomer, 0.12 parts of polyethylene glycol-8, 0.85 parts of PEG-40 hydrogenated castor oil, 5-15 parts of glycerol, 0.01-0.05 parts of ethylparaben, 65.85-93.17 parts of purified water, etc. The gel composition can effectively relieve itching symptoms caused by skin allergies, eczema, or mosquito bites.

[0012] Among the above prior arts, there are certain effects on different itching symptoms, mainly for moisturizing, soothing and relieving itching, and for mild itching symptoms, Chinese patent medicines for dispelling wind and relieving itching are mainly taken orally in clinical practice, and work through systemic regulation. Oral administration is a common method in clinical practice, and topical administration to the skin is also a good way. In order to achieve good therapeutic effects, requirements are placed on the characteristics of Chinese medicine prescription drugs, extraction processes and preparations. Most drugs that are effective for oral administration may not be effective for skin administration, or the effects are not obvious, and the purpose of treatment cannot be achieved. The reason is that the skin, as a protective organ of the body, prevents the invasion of viruses and bacteria, and also prevents the entry of drugs. Summary of the invention

[0013] To solve the above problems, the present invention aims to provide a Chinese medicine external preparation with strong wind-dispelling and itching-relieving effects and rapid onset of action. The preparation method thereof is easy to industrialize and has low cost. The prepared gel or ointment can exhibit excellent anti-inflammatory, itching-relieving and anti-inflammatory effects without any side effects.

[0014] In order to achieve the above-mentioned invention object, the present invention provides the following technical solutions:

[0015] A Chinese medicine external preparation for dispelling wind and relieving itching, which is composed of the following medicinal raw materials by weight: 10-30 parts of stir-fried Xanthium sibiricum fruit, 10-30 parts of Kochia scoparia fruit, 10-30 parts of Chuanxiong rhizome, 10-30 parts of Carthamus tinctorius, and 5-15 parts of Sophora flavescens; the extraction process is selected from any one of the following:

[0016] Method 1: Add water to stir-fried Xanthium sibiricum, Kochia scoparia, Chuanxiong, Carthamus tinctorius, and Sophora flavescens according to the above proportions for 2-3 times, take the supernatant, filter, and concentrate the filtrate to a clear paste of 1.20-1.35 to obtain the product;

[0017] Method 2: Add water to the stir-fried Xanthium sibiricum, Kochia scoparia, Chuanxiong, Carthamus tinctorius, and Sophora flavescens according to the above proportions for extraction 2-3 times, concentrate and precipitate with alcohol for 12-24 hours, take the supernatant, filter, and concentrate the alcohol filtrate under reduced pressure to a clear paste with a relative density of 1.20-1.35 to obtain the product;

[0018] Method 3: stir-fry Xanthium sibiricum, Kochia scoparia, Chuanxiong, Carthamus tinctorius, and Sophora flavescens in the above proportions, use 30%-80% ethanol as the extraction solution, extract for 18h-48h, take the extract and concentrate it under reduced pressure to obtain the product;

[0019] Method 4: Add stir-fried Xanthium sibiricum, Kochia scoparia, Ligusticum chuanxiong, Carthamus tinctorius, and Sophora flavescens in the above proportions with 30%-70% glycerol as the extraction solution, extract for 18h-48h, filter, and obtain the glycerol extract; extract the residue with water or 50-80% ethanol, filter, and concentrate the filtrate to obtain the product.

[0020] Preferably, the extraction process is: add water to stir-fried Xanthium sibiricum, Kochia scoparia, Ligusticum chuanxiong, Carthamus tinctorius and Sophora flavescens according to the above proportions, extract 2-3 times, concentrate the extract to a relative density of 1.10-1.25, add alcohol to an alcohol content of 60%-75%, and after alcohol precipitation for 12-20 hours, take the supernatant, filter, and concentrate the alcohol filtrate under reduced pressure to a clear paste with a relative density of 1.20-1.35 to obtain the product.

[0021] The specific formula of the embodiment is further preferred: the Chinese medicine external preparation is composed of the following raw materials: 20 parts of stir-fried Xanthium sibiricum, 20 parts of Kochia scoparia, 20 parts of Chuanxiong, 20 parts of Carthamus tinctorius, and 10 parts of Sophora flavescens.

[0022] The specific formula of the embodiment is further preferred: the Chinese medicine external preparation is composed of the following raw materials: 18 parts of stir-fried Xanthium sibiricum fruits, 19 parts of Kochia scoparia fruits, 20 parts of Chuanxiong, 21 parts of Carthamus tinctorius, and 12 parts of Sophora flavescens.

[0023] The specific formula of the embodiment is further preferred: the Chinese medicine external preparation is composed of the following raw materials: 19 parts of stir-fried Xanthium sibiricum fruits, 20 parts of Kochia scoparia fruits, 18 parts of Chuanxiong, 19 parts of Carthamus tinctorius, and 11 parts of Sophora flavescens.

[0024] Preferably, the traditional Chinese medicine external preparation includes a gel, cream, solution or film-coating made of pharmaceutically acceptable excipients.

[0025] Preferably, the external Chinese medicine preparation is a gel, which comprises, by weight, 20-100 parts of the product prepared above, 0.1-2.0 parts of carbomer, 0.1-0.2 parts of sodium propylparaben, 10-30 parts of glycerol, 130-150 parts of water, and triethanolamine to adjust the pH to 6.0-8.0.

[0026] Preferably, the Chinese medicine external preparation is a solution, which comprises 20-40 parts of the product prepared above, 50-80 parts of water, 10-30 parts of glycerol, 0.1-0.5 parts of disodium edetate, and 0.1-0.5 parts of tartaric acid.

[0027] Preferably, the external Chinese medicine preparation is a film coating agent, which includes 20-35 parts of the product prepared above, 5-15 parts of polyvinyl alcohol, 0.2-0.8 parts of sodium propylparaben, 10-30 parts of glycerol, and 120-150 parts of 50%-60% ethanol solution.

[0028] The present invention also provides the use of the traditional Chinese medicine external preparation in preparing medicines for treating urticaria, eczema, urticaria, allergic dermatitis, rhinitis and other pruritus-induced pruritus diseases.

[0029] Compared with the prior art, the advantages of the present invention are:

[0030] 1. The present invention is based on the theory of traditional Chinese medicine, combined with the experience of inventing Chinese medicine research and development, comparing various Chinese medicine prescriptions, repeatedly conducting comparative studies on extraction processes, and finally selecting the formula product of the present invention as the research object (see Example 1). Compared with oral preparations, effective preparations for transdermal administration can not only reach drug concentrations at the site of action at a fast speed, but also have the advantages of avoiding the first-pass effect of the liver and gastrointestinal inactivation, maintaining a constant drug concentration, fewer side effects, and increasing medication compliance. The results of the efficacy study of the present invention show that the antipruritic effect of the composition of the present invention for skin administration is significantly better than that of the oral preparation of the same prescription and the positive control drug Pi Yan Ping, and its application is not limited to mild to moderate itching, and can be used for moderate to severe, or even refractory pruritus.

[0031] 2. The present invention obtains a better preparation method through prescription screening and repeated optimization of the extraction process, and changes the administration route of oral skin itching granules to an external preparation, which significantly improves the efficacy, significantly reduces the amount of medicinal materials and costs, and also significantly reduces the probability of systemic adverse reactions.

[0032] 3. The external preparation of the present invention has a uniform and fine texture, is easy to apply on the skin, and because it has good adhesion, does not produce large fluidity, is more convenient to use, and has a strong effect, low drug concentration, excellent process, not deep color, and the dosage form is easy to clean and does not pollute clothing. Most importantly, the gel of the product has the characteristics of fast drug release, long retention time and no irritation to human skin. The external Chinese medicine preparation of the present invention is different from the general external Chinese medicine preparation with deep color and poor use, and has good clinical compliance.

[0033] The causes of pruritus are complex, including both internal and external causes. The topical preparation of the present invention is mainly used for pruritus caused by allergic causes, such as urticaria, eczema, atopic dermatitis, rhinitis, etc. The present invention can well control the symptoms of pruritus and rhinitis.

[0034] The detailed structure of the present invention is further described below in conjunction with specific implementation methods. DETAILED DESCRIPTION

[0035] Example 1

[0036] A traditional Chinese medicine external preparation for dispelling wind and relieving itching, wherein the medicinal raw materials of the traditional Chinese medicine external preparation are as follows by weight: 20 parts of stir-fried Xanthium sibiricum, 20 parts of Kochia scoparia, 20 parts of Chuanxiong, 20 parts of Carthamus tinctorius, and 10 parts of Sophora flavescens; extraction process: stir-fried Xanthium sibiricum, Kochia scoparia, Chuanxiong, Carthamus tinctorius, and Sophora flavescens are extracted 2-3 times with water, the extract is concentrated to a relative density of 1.10-1.25 (measured at 20°C), alcohol is added to 50-80%, supernatant is taken after 12-24 hours, filtered, and the alcohol filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.20-1.35 (measured at 20°C), so as to obtain a skin itching cream, which is the product of Example 1 of the present invention.

[0037] The part means part by weight, generally representing g.

[0038] The selection process of the research object of the present invention

[0039] The inventors first analyzed Xiaofeng Zhiyang Cream, Fuyang Cream, and Guixiong Nourishing Skin Milk, and combined with the characteristics of skin administration preparations, the three prescriptions were tested for anti-inflammatory and antipruritic effects in mice. The results showed that Xiaofeng Zhiyang Cream had no obvious effect after transdermal administration, Guixiong Nourishing Skin Milk had certain pharmacological activity, but the effect was not obvious; Fuyang Granules had the strongest effect and had the potential to be a medicine. The Fuyang Granules are the subsequent research objects of the present invention.

[0040] The specific experiments are as follows:

[0041] Study on the efficacy screening of Xiaofengzhiyang cream, Fuyang cream and Guixiong nourishing skin cream

[0042] 1. Research objectives

[0043] This study conducted a comparative study on the antipruritic efficacy screening of Xiaofeng Zhiyang Cream, Fuyang Cream and Guixiong Yangfu Cream, in order to provide a basis for evaluating the clinical value assessment and clinical application of new drug development.

[0044] 2. Test Materials

[0045] 2.1 Test products

[0046] 2.1.1 Xiaofeng Zhiyang Cream (comparative product) is prepared by adopting the formulation of Xiaofeng Zhiyang Granules, a marketed product, and extracting intermediates through extraction process, batch number: 20033101.

[0047] Xiaofeng Zhiyang Granules, eliminate wind, clear heat, remove dampness and stop itching. Mainly used for papular urticaria, also used for eczema and skin pruritus. Prescription composition: 50g of Saposhnikovia divaricata, 50g of cicada shell, 90g of Radix Digu, 60g of Atractylodes macrocephala (fried), 90g of linseed, 90g of Angelica sinensis, 150g of Rehmannia glutinosa, 30g of Aristolochia ternata, 50g of Nepeta tenuifolia, 30g of Gypsum, 30g of Licorice. Preparation method: Take the above eleven flavors, crush the gypsum, add water and boil for 2 hours, add the remaining ten flavors such as Saposhnikovia divaricata and continue to decoct twice, the first time for 3 hours, the second time for 2 hours, combine the decoction, filter, and concentrate the filtrate to an appropriate amount (0.5q medicinal material per 1ml). Add ethanol to make the alcohol content reach 70%, stir well, let stand, filter, and concentrate the filtrate to a clear paste with a relative density of about 1.36 (20°C), and then add excipients to prepare a cream.

[0048] 2.1.2 Skin itching cream (the product of Example 1 of the present invention) is prepared by adopting the prescription of skin itching granules of the marketed variety and extracting the intermediates through the extraction process. Prescription composition: 20 parts of stir-fried Xanthium sibiricum, 20 parts of Kochia scoparia, 20 parts of Ligusticum chuanxiong, 20 parts of Carthamus tinctorius, and 10 parts of Sophora flavescens. Preparation method: Extract with water 2-3 times, concentrate the extract to a relative density of 1.10-1.25 (measured at 20°C), add alcohol to 50-80%, take the supernatant after 12-24 hours, filter, and concentrate the alcohol filtrate under reduced pressure to a relative density of 1.20-

[0049] 1.35 (measured at 20℃) of clear paste, and then add auxiliary materials to prepare cream. Batch number: 20033101. Fuyang granules are a Chinese patent medicine for dermatology, which has the effects of dispelling wind, activating blood circulation, removing dampness and relieving itching. It is mainly used in the treatment of skin pruritus and urticaria.

[0050] 2.1.3 Guixiong Skin Nourishing Lotion (comparison product), batch number: 20190711.

[0051] This product is used for dry skin, pruritus in the elderly, atopic dermatitis, etc. It has the effects of clearing away heat, cooling blood, removing dampness and relieving itching.

[0052] Prescription composition: Bolbostemma paniculatum 60g, Ligusticum chuanxiong 35g, Angelica sinensis 45g, Carthamus tinctorius 25g, Armeniaca vulgaris 45g, Galla chinensis 15g, Kochia scoparia 35g; Add 12 times the amount of water and extract twice for 2 hours; Combine the extracts, concentrate to a relative density of 1.2 - 1.25 (°C), add 95% ethanol to make the ethanol content 55 - 60%, let stand for 48 hours, take the supernatant, recover ethanol under pressure until there is no alcohol smell, reserve for use, and then add excipients to prepare a cream.

[0053] 2.2 Positive control drug

[0054] Compound dexamethasone acetate ointment, batch number: 2001031X, purchased from China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.; Paeonol ointment, batch number: 200512, purchased from Changchun Puhua Pharmaceutical Co., Ltd.

[0055] 2.3 Experimental animals

[0056] 36 guinea pigs, half male and half female, weighing 250 - 300g, purchased from Wuhan Wanqian Jiaxing Biotechnology Co., Ltd., production license number of experimental animals: SCXK(E)2016 - 0011; Raised in the barrier environment of Hunan Drug Safety Evaluation and Research Center, experimental animal use license number: SYXK(Xiang)2015 - 0016.

[0057] 2.4 Main reagents

[0058] Histamine phosphate, batch number: Q29M10D84345, Shanghai Yuanye Bio-Technology Co., Ltd.; Pure water,自制 by this center.

[0059] 2.5 Main instruments

[0060] AUY220 type analytical balance, AUW - 220D type analytical balance, products of Mettler company; ME2002E type electronic balance, products of Mettler company.

[0061] 3. Test methods

[0062] 3.1 Therapeutic effects of Xiaofeng Zhiyang Cream, Fuyang Cream (product of Example 1 of the present invention), and Guixiong Yangfu Milk on histamine-induced acute pruritus guinea pig model

[0063] 36 guinea pigs, half male and half female, weighing 250 - 300g, were randomly divided into a model control group, Xiaofeng Zhiyang Cream qd, bid groups, Fuyang Cream (product of Example 1 of the present invention) qd, bid groups, Guixiong Yangfu Milk qd, bid groups, Compound dexamethasone acetate cream bid group, Paeonol ointment bid group (control group) according to body weight, with 6 in each group. The hair on the right hind foot back of each group of guinea pigs was shaved in an area of 1.5 cm × 1.5 cm, and the test substances were evenly applied to the shaved area, with the dosage of 0.1 g·cm each time. -2The administration area was about 1 cm×1 cm. The Xiaofeng Zhiyang Cream, Fuyang Cream (the product of Example 1 of the present invention), and Guixiong Yangfu Milk qd group were administered once a day, and the dexamethasone acetate cream bid group, paeonol ointment bid group, Xiaofeng Zhiyang Cream, Fuyang Cream (the product of Example 1 of the present invention), and Guixiong Yangfu Milk bid group were administered twice a day, with an interval of 3 hours, and all were used for 6 consecutive days. On the 7th day of administration, the shaved areas were scratched with coarse sandpaper to injure the epidermis, and slight bleeding was considered as the degree. Apply the test substance or control substance to the wound once. Ten minutes after application, drip 0.01%, 0.02%, 0.03%, 0.04%, 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.10%, 0.2%, 0.3% histamine phosphate 50 μL / guinea pig on the wound every 3 minutes until the guinea pig turns its head and licks its right hind paw. Record the number of histamine phosphate drops and the time when itching signs appear.

[0064] 3.2 Dose setting

[0065] Table 1 Trial grouping and dosage design

[0066]

[0067] 3.3 Detection indicators

[0068] The reaction of guinea pigs licking their right hind paw was used as an indication of itch. The itch latency, the number of histamine phosphate administrations, and the total amount of histamine phosphate used were observed and recorded after the histamine application. Itch latency: the time when the animal first experienced itch; the number of histamine phosphate administrations: the number of histamine phosphate administrations when the animal experienced itch; histamine phosphate threshold: the total amount of histamine phosphate used when the animal experienced itch.

[0069] 3.4 Data processing and statistical analysis

[0070] SPSS 16.0 was used for statistical analysis, and the level of statistical significance was set at P < 0.05. Leven's test was used to test normality and variance homogeneity. If normality and variance homogeneity were met (P>0.05), one-way analysis of variance (ANOVA) and post Hoc LSD were used for inter-group statistical analysis. For data that did not meet normality and variance homogeneity (P<0.05), appropriate variable transformation was performed. After the normality or variance homogeneity requirements were met, the transformed data were used for statistics. If the variables still did not meet the normality or variance homogeneity requirements after transformation, the rank sum test was used for statistics. Statistical differences and biological significance were considered during the evaluation.

[0071] 4. Experimental Results

[0072] 4.1 Effects of Xiaofeng Zhiyang Cream, Fuyang Cream (product of Example 1 of the present invention), and Guixiong Nourishing Skin Lotion on the Latent Period of Pruritus

[0073] As shown in Table 2, compared with the model control group, the incubation period of the dexamethasone acetate ointment bid group, the paeonol ointment bid group, the itching cream (the product of Example 1 of the present invention) qd, bid group, and the angelica sinensis nourishing skin cream bid group were significantly prolonged (P≤0.05 or P≤0.01).

[0074] Table 2. Effects of Xiaofeng Zhiyang Cream, Fuyang Cream (product of Example 1 of the present invention), and Guixiong Nourishing Skin Lotion on the Latent Period of Pruritus

[0075]

[0076] Note: Compared with the model control group, * P≤0.05, ** P≤0.01

[0077] 4.2 Effects of Xiaofeng Zhiyang Cream, Fuyang Cream (the product of Example 1 of the present invention), and Guixiong Yangfu Cream on the Phosphate Histamine Threshold of the Itch Latency Period

[0078] As shown in Table 2, compared with the model control group, the histamine phosphate threshold and the number of histamine phosphate additions in the dexamethasone acetate ointment bid group, the paeonol ointment bid group, the itching cream (the product of Example 1 of the present invention) qd, bid group, and the angelica sinensis skin care lotion bid group all showed significant increases (P≤0.05).

[0079] Table 3. Effects of Xiaofeng Zhiyang Cream, Fuyang Cream (product of Example 1 of the present invention), and Guixiong Yangfu Lotion on the Phosphate Histamine Threshold of the Itch Latency Period

[0080]

[0081] Note: Compared with the model control group, * P≤0.05

[0082] 5. Discussion

[0083] Itch is a specific skin sensation that can trigger the desire to scratch and the scratching reflex. It is a common manifestation of a variety of skin diseases such as atopic dermatitis, psoriasis, and urticaria. The mechanisms of pruritus mainly include histamine-dependent pruritus and non-histamine-dependent pruritus. Histamine is an important endogenous itch-causing substance that activates sensory neurons through histamine-dependent pathways to produce itch signals. In this experiment, the acute pruritus model induced by histamine was simulated by applying histamine phosphate solution to the wound surface produced by coarse sandpaper friction to study the efficacy of Xiaofeng Zhiyang Ointment, Fuyang Ointment, and Guixiong Yangfu Milk in treating pruritus. The results showed that Xiaofeng Zhiyang ointment did not show pharmacological effects, Guixiong nourishing skin lotion had certain effects, and the itching cream (the product of Example 1 of the present invention) could effectively prolong the latency of histamine phosphate-induced pruritus and improve the histamine phosphate threshold for the latency period of pruritus. The itching cream (the product of Example 1 of the present invention) was the most superior, and both doses showed good effects, with strengths similar to those of the marketed paeonol ointment. Further optimization of the extraction process and the preparation process is expected to achieve the strength of dexamethasone acid ointment, be clinically effective, and solve the adverse reactions and medication restrictions caused by long-term use of hormones.

[0084] The present invention fully considers the respective characteristics and clinical needs of skin administration and oral administration, the pharmacokinetic characteristics of intestinal absorption and transdermal preparations, and combines the requirements of industrial production to further optimize the extraction and purification technology of the itch particles, and selects and optimizes the extraction and purification process through chemical composition and efficacy judgment technology, and determines that one of the following three methods can be used for extraction and preparation, and obtains the optimal process of Example 1 of the present invention.

[0085] Example 2: Comparative study on extraction solvent, extraction process screening and administration route of itching cream (product of the present invention) (HNSE2023(3)020)

[0086] 1 Materials

[0087] 1.1 Experimental animals

[0088] Hartley guinea pigs, ordinary grade, 100, half male and half female, weighing 300-340 g, were purchased from Hunan Tianqin Biotechnology Co., Ltd., with experimental animal production license number: SCXK (Xiang) 2019-0015; they were raised in the ordinary environment area E of Hunan Prima Pharmaceutical Research Center Co., Ltd., with experimental animal use license number: SYXK (Xiang) 2020-0015.

[0089] 1.2 Main reagents and instruments

[0090] 2103FY water-extracted clear paste, batch number: FY230314; specification: 0.30g crude drug / g extract; validity period: 2023.06.13; 2103FY alcohol-extracted clear paste, batch number: FY230310; specification: 0.30g crude drug / g extract; validity period: 2023.06.09; 2103FY water-extracted alcohol-precipitated clear paste, batch number: FY230316; specification: 0.30g crude drug / g extract; validity Date: 2023.06.15; 2103FY glycerin + alcohol extract paste, batch number: FY230320; specification: 0.30g crude drug / g extract; validity period: 2023.06.19; 2103FY glycerin + water extract paste, batch number: FY230318; specification: 0.30g crude drug / g extract; validity period: 2023.06.17; The above samples are provided by Hunan Prima Drug Research Center Co., Ltd.

[0091] Method for water extraction of clear paste: add water to stir-fried Xanthium sibiricum, Kochia scoparia, Chuanxiong, Carthamus tinctorius, and Sophora flavescens according to the above proportions for extraction three times, take the supernatant, filter, and concentrate the filtrate to a clear paste of 1.20-1.35, and the product is obtained;

[0092] Method for water extraction and alcohol precipitation of clear paste: add water to stir-fried Xanthium sibiricum, Kochia scoparia, Ligusticum chuanxiong, Carthamus tinctorius and Sophora flavescens according to the above proportions for extraction three times, concentrate the extract to a relative density of 1.10-1.25, add alcohol to a concentration of 65%, and after alcohol precipitation for 12 hours, take the supernatant, filter, and concentrate the alcohol filtrate under reduced pressure to a clear paste with a relative density of 1.20-1.35 to obtain the product.

[0093] The method of alcohol extraction of clear paste is as follows: stir-fry Xanthium sibiricum, Kochia scoparia, Chuanxiong, Carthamus tinctorius, and Sophora flavescens in the above proportions, use 40% ethanol as the extraction solution, extract for 18 hours, take the extract and concentrate it under reduced pressure to obtain the product;

[0094] The method of extracting a clear paste with glycerin + alcohol or a clear paste with glycerin + water is as follows: stir-fry Xanthium sibiricum, Kochia scoparia, Ligusticum chuanxiong, Carthamus tinctorius, and Sophora flavescens in the above proportions, use 30% glycerin as the extraction solution, extract for 18 hours, filter, and obtain a glycerin extract; extract the residue with water or 60% ethanol, filter, and concentrate the filtrate to obtain the product.

[0095] Dehumidifying and antipruritic ointment, batch number 221102; specification 20g*1 tube / box; expiration date: 2024.10.31; manufacturer: Sichuan Defeng Pharmaceutical Co., Ltd.; functions and indications: clearing away heat and dampness, dispelling wind and relieving itching. Used as an auxiliary treatment for acute and subacute eczema with damp-heat or dampness-blocking syndrome; dosage and administration: for external use, 3 to 4 times a day, apply to the affected area.

[0096] Itch Granules, batch number: 20210606; specification 9g*9 bags / box; manufacturer: Sunflower Pharmaceutical; functions and indications: dispel wind and activate blood circulation, remove dampness and relieve itching. Used for skin itching and urticaria; dosage: take with boiled water, 3 times a day, 2 bags each time.

[0097] Histamine, manufacturer: RYON; batch number: RA20L0507. Preparation of histamine modeling reagent: accurately weigh 0.1224 g of histamine and dilute to 48 mL (0.25%) with pure water.

[0098] CJ-1F medical clean bench (Suzhou Fengshi Experimental Animal Equipment Co., Ltd.); ME2002E electronic balance / 560; pipette (Beijing Dalong pipette Dragonlab TopPette).

[0099] 2 Methods

[0100] 2.10.25% histamine solution induced acute pruritus model in guinea pigs

[0101] 84 Hartley guinea pigs that passed the quarantine were selected and randomly divided into a normal control group, a solvent control group, a skin itch granule group (4.185 g / kg), a dehumidifying and antipruritic ointment group (0.05 g / mouse / time), a skin itch cream (the product of Example 1 of the present invention), a process 1 low-dose group (2103FY water-extracted clear ointment, the dosage of which was 0.0015 g crude drug / cm 2 、0.015g crude drug / cm 2 ), itchy cream (product of Example 1 of the present invention) process 2 low- and high-dose groups (2103FY alcohol-extracted cream, the dosage was 0.0015 g crude drug / cm 2 、0.015g crude drug / cm 2 ), itchy cream (the product of Example 1 of the present invention) process 3 low- and high-dose groups (2103FY water-extracted alcohol-precipitated cream, the dosage was 0.0015 g crude drug / cm 2 、0.015g crude drug / cm 2 ), itchy cream (product of Example 1 of the present invention) process 4 low- and high-dose groups (2103FY glycerol + alcohol extract cream, the dosage was 0.0015g crude drug / cm 2 、0.015g crude drug / cm 2 ), itchy cream (product of Example 1 of the present invention) process 5 low and high dose groups (2103FY glycerol + water extract clear cream, the dosage is 0.0015g crude drug / cm 2 、0.015g crude drug / cm 2), 6 animals in each group. The day before group administration, the 1.5cm×1.5cm administration area was shaved on the back of the right hind foot of each group of guinea pigs. On the day of group administration, the test substance was evenly applied to the shaved area, and the administration area was 1cm×1cm. The administration was once in the morning and afternoon every day for 7 consecutive days. One hour after the last administration, the shaved administration area on the back of the right hind foot was scratched with coarse sandpaper until the skin turned red. 0.25% histamine 50μL / guinea pig was added to the scratched area with a pipette to induce an itch reaction in the guinea pig (turning back and licking the right hind foot). Thereafter, it was added every 3 minutes until the guinea pig turned back and licked the right hind foot. The total amount of histamine given to each guinea pig that turned back and licked the right hind foot was recorded as the itch threshold. If the guinea pig did not turn back and lick the right hind foot within 30 minutes, the total amount of histamine given within 30 minutes was recorded as the itch threshold. The grouping and dosage design are detailed in Table 1.

[0102] Table 1 Trial grouping and dosage design

[0103]

[0104]

[0105] Note: The normal control group was given pure water, and the solvent control group was given glycerol. The route of administration, dosage, and number of administrations were consistent with those of the dehumidifying and antipruritic ointment group.

[0106] 2.2 Statistical methods

[0107] The significant figures of the experimental data were rounded off and statistical analysis was performed in accordance with relevant regulations. The statistical software used was SPSS23.0. The measurement data were expressed as mean ± standard deviation. Indicates that Leven's test method was used to test normality and homogeneity of variance. If there was no statistical significance (P>0.05), one-way analysis of variance (ANOVA) was used for statistical analysis. If ANOVA was statistically significant (P≤0.05), LSD test (parametric method) was used for comparative analysis. If the variance was unequal (P≤0.05), Kruskal-Wallis test was used. If the Kruskal-Wallis test was statistically significant (P≤0.05), Dunnett's Test (non-parametric method) was used for comparative analysis. The statistical results were tested with α=0.05 as the test limit, where P≤0.05 indicated statistical significance, and P≤0.01 indicated that the difference tested was very significant.

[0108] 3 Experimental results

[0109] As shown in Table 2, there was no significant difference in the itch threshold of guinea pigs among low-dose 2103FY water-extracted ointment, low-dose 2103FY alcohol-extracted ointment and low-dose 2103FY glycerol + water-extracted ointment; high-dose 2103FY water-extracted alcohol-precipitated ointment, high-dose 2103FY skin itch granules, dehumidifying and antipruritic ointment, high-dose 2103FY alcohol-extracted ointment, low-dose 2103FY water-extracted alcohol-precipitated ointment and low-dose 2103FY glycerol + alcohol-extracted ointment; high-dose 2103FY glycerol + water-extracted ointment and high-dose 2103FY glycerol + alcohol-extracted ointment were better than high-dose 2103FY water-extracted ointment, skin itch granules, dehumidifying and antipruritic ointment, high-dose 2103FY alcohol-extracted ointment and low-dose 2103FY glycerol + alcohol-extracted ointment in increasing the itch threshold of guinea pigs. The ability of 2103FY water-extracted alcohol-precipitated ointment to increase the itch threshold of guinea pigs is better than that of other process groups of 2103FY with the same dose, showing the best antipruritic effect.

[0110] In summary, the extraction process samples of the itching cream (the product of Example 1 of the present invention) 2103FY water-extracted clear cream high dose, 2103FY water-extracted alcohol-precipitated clear cream high dose, itching granules, dehumidifying and antipruritic ointment, 2103FY alcohol-extracted clear cream high dose, 2103FY water-extracted alcohol-precipitated clear cream low dose, 2103FY glycerin + alcohol-extracted clear cream low dose, 2103FY glycerin + water-extracted clear cream high dose and 2103FY glycerin + alcohol-extracted clear cream high dose all have significant antipruritic effects on histamine-induced acute itching in guinea pigs, and the water-extracted alcohol-precipitated clear cream has the best efficacy.

[0111] Table 2 Comparison of itch thresholds of guinea pigs in each group ( n=6)

[0112]

[0113] Note: Compared with the normal control group: *P<0.05; **P<0.01; ***P<0.001;

[0114] Example 3 Extraction and purification process screening efficacy test of itchy cream (product of Example 1 of the present invention) (HNSE2023(3)020-002)

[0115] 1 Materials

[0116] 1.1 Experimental animals

[0117] Hartley guinea pigs, ordinary grade, 100, half male and half female, weighing 300-340 g, were purchased from Hunan Tianqin Biotechnology Co., Ltd., with experimental animal production license number: SCXK (Xiang) 2019-0015; they were raised in the ordinary environment area E of Hunan Prima Pharmaceutical Research Center Co., Ltd., with experimental animal use license number: SYXK (Xiang) 2020-0015.

[0118] 1.2 Main reagents and instruments

[0119] 2103FY water-extracted alcohol-precipitated ointment, batch number: FY230316; specification: 0.30g crude drug / g extract; expiration date: 2023.06.15

[0120] 2103FY glycerin + alcohol extract cream, batch number: FY230320; specification: 0.30g crude drug / g extract; expiration date: 2023.06.19

[0121] 2103FY glycerol, batch number: FY230318; from Shandong Ruisheng Pharmaceutical Excipients Co., Ltd.

[0122] Piyanping, batch number 2203074X; specification 20g*1 piece / box; manufacturer: Guangdong China Resources Shunfeng Pharmaceutical Co., Ltd.; used for localized pruritus, neurodermatitis, contact dermatitis, seborrheic dermatitis and chronic eczema; dosage and administration: for external use, 1 to 2 times a day, apply to the affected area.

[0123] Fuyang Granules, batch number: 2210115; specification 9g*10 bags / box; manufacturer: Sichuan Shenghe Pharmaceutical Co., Ltd.; functions and indications: dispel wind and activate blood circulation, remove dampness and relieve itching. Used for skin itching and urticaria; dosage: take with boiled water, 3 times a day, 2 bags each time.

[0124] Histamine, manufacturer: RYON; batch number: RA20L0507. Preparation of histamine modeling reagent: accurately weigh 0.1224 g of histamine and dilute to 48 mL (0.25%) with pure water.

[0125] CJ-1F medical clean bench (Suzhou Fengshi Experimental Animal Equipment Co., Ltd.); ME2002E electronic balance / 560; pipette (Beijing Dalong pipette Dragonlab TopPette)

[0126] 2 Methods

[0127] 2.10.25% histamine solution induced acute pruritus model in guinea pigs

[0128] 42 Hartley guinea pigs that passed the quarantine were selected and randomly divided into a solvent control group, a Fuyang granule group (4.185 g / kg), a Piyanping group (0.05 g / mouse / time), a Fuyang cream (the product of Example 1 of the present invention), a process 1 low-dose group (2103FY water-extracted alcohol-precipitated cream, the dosage of which was 0.0015 g crude drug / cm 2 、0.015g crude drug / cm 2), itchy cream (the product of Example 1 of the present invention) process 2 low- and high-dose groups (2103FY glycerol + alcohol extract cream, the dosage is 0.0015g crude drug / cm 2 、0.015g crude drug / cm 2 ), 6 animals in each group. The day before group administration, the 1.5cm×1.5cm administration area was shaved on the back of the right hind foot of each group of guinea pigs. On the day of group administration, the test substance was evenly applied to the shaved area, and the administration area was 1cm×1cm. The administration was once in the morning and afternoon every day for 7 consecutive days. One hour after the last administration, the shaved administration area on the back of the right hind foot was scratched with coarse sandpaper until the skin turned red. 0.25% histamine 50μL / guinea pig was added to the scratched area with a pipette to induce an itch reaction in the guinea pig (turning back and licking the right hind foot). Thereafter, it was added every 3 minutes until the guinea pig turned back and licked the right hind foot. The total amount of histamine given to each guinea pig that turned back and licked the right hind foot was recorded as the itch threshold. If the guinea pig did not turn back and lick the right hind foot within 30 minutes, the total amount of histamine given within 30 minutes was recorded as the itch threshold. The grouping and dosage design are detailed in Table 3.

[0129] Table 3 Trial grouping and dosage design

[0130]

[0131]

[0132] Note: The solvent control group was given glycerol, and the route of administration, dosage, and number of administrations were consistent with those of the sample group; 3 Experimental results

[0133] As shown in Table 4, the test sample groups were analyzed from the perspective of the arithmetic mean of the threshold value: different extraction processes all had certain antipruritic effects. Among them, the threshold value of the high-dose group of 2103FY water-extracted alcohol-precipitated cream was the highest, showing a good antipruritic effect. At the same time, the threshold standard deviation value analysis of the high-dose group of 2103FY water-extracted alcohol-precipitated cream also had relatively stable data, and the data were concentrated near the mean, with good data reproducibility. In the statistical analysis, the threshold values ​​of each test sample group VS the threshold value of the solvent control group: the P value of all test groups was 0.000, which was significantly different from the normal group, but the arithmetic mean value of the threshold value of the high-dose group of 2103FY water-extracted alcohol-precipitated cream was lower than that of other dosing groups, and the stability of the threshold standard deviation value was also lower than that of other dosing groups. Among 2103FY water-extracted alcohol-precipitated cream and 2103FY glycerol + alcohol-extracted cream, the one with significant antipruritic effect was 2103FY water-extracted alcohol-precipitated cream, and the dosage was 0.015g crude drug / cm 2 .

[0134] In summary, the extraction process samples of the itching cream (the product of Example 1 of the present invention) 2103FY water-extracted alcohol-precipitated cream low dose, 2103FY water-extracted alcohol-precipitated cream high dose, itching granules, dermatitis cream, 2103FY glycerol + alcohol-extracted cream low dose and 2103FY glycerol + alcohol-extracted cream high dose all have significant antipruritic effects on histamine-induced acute itching in guinea pigs, and the efficacy of 2103FY water-extracted alcohol-precipitated cream high dose is the best.

[0135] Table 4 Comparison of itch thresholds of guinea pigs in each group ( n=6)

[0136]

[0137]

[0138] Example 4

[0139] Traditional Chinese medicine for external use has the problems of large dosage and dark color. Clinical use may affect appearance and stain clothing, etc. It is necessary to optimize the clinical dosing regimen through preparation and efficacy research. Based on this consideration, this prescription has conducted research on gels, emulsions, solutions (ointments, sprays), etc.

[0140] An external medication preparation capable of relieving itching comprises the following raw materials: 18 parts of stir-fried Xanthium sibiricum fruit, 19 parts of Kochia scoparia fruit, 20 parts of Chuanxiong rhizome, 21 parts of safflower and 12 parts of Sophora flavescens.

[0141] The preparation method of the external drug-administered preparation of the present invention comprises the following steps: (1) extraction: the above five flavors are decocted twice with water, soaked in water for 45 minutes and then decocted for 1-2 hours, the decoctions are combined and filtered through 200 mesh.

[0142] (2) Concentration: The filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.10 to 1.15 (measured at 60°C), and then cooled to room temperature.

[0143] (3) Alcohol precipitation: add ethanol to the clear paste to make the alcohol content of the supernatant reach 65%, and precipitate for 16 hours. Filter and concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.25-1.35 (measured at 60°C) for later use.

[0144] (4) Preparation: Select about 21 parts of the thick paste of step 3, and the auxiliary materials: 1.4 parts of carbomer homopolymer type C, 21 parts of glycerol, 0.14 parts of propylparaben sodium, and 4 parts of triethanolamine; weigh 0.2 parts of propylparaben sodium and add it to a mixing tank filled with purified water, stir to dissolve, add carbomer homopolymer type C and stir slightly, soak overnight to make it into a suspension, and set aside. Add the reserved thick paste to carbomer homopolymer type C or other dissolution-promoting and dispersing auxiliary material solution, add glycerol, stir evenly, add triethanolamine in an appropriate amount to adjust the pH value, stir evenly, add purified water in an appropriate amount to make the total weight to 142 parts, stir evenly, and divide into packages to obtain.

[0145] The medicinal effects are the same as those of the water-extraction and alcohol-precipitation product of Example 1, and will not be repeated here.

[0146] Example 5 Preparation of coating agent

[0147] Prescription herbs: 19 parts of stir-fried Xanthium sibiricum, 20 parts of Kochia scoparia, 18 parts of Chuanxiong, 19 parts of Carthamus tinctorius, and 11 parts of Sophora flavescens;

[0148] Preparation excipients: 10 parts of polyvinyl alcohol, 22 parts of glycerol, 0.5 parts of sodium propylparaben, and appropriate amount of 60% ethanol.

[0149] The preparation method of the skin itch gel comprises the following steps: (1) extraction: the above five flavors are decocted twice with water, the first time 8 times the amount of water is added to soak for 45 minutes and then decocted for 2 hours, the second time 8 times the amount of water is added to decoct for 1 hour, the decoctions are combined and filtered through 200 mesh.

[0150] (2) Concentration: The filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.10 to 1.15 (measured at 60°C), and then cooled to room temperature.

[0151] (3) Alcohol precipitation: add ethanol to the clear paste to make the alcohol content of the supernatant reach 65%, precipitate for 16 hours, filter through 300 mesh, and concentrate the filtrate under reduced pressure (-0.08MPa to -0.10MPa) at 50°C to 70°C to a thick paste with a relative density of 1.25 to 1.35 (measured at 60°C) of about 21 parts, which is set aside.

[0152] (4) Preparation: Weigh 0.5 parts of sodium propylparaben and add it to a mixing tank containing 60% ethanol, stir to dissolve, add 7 parts of polyvinyl alcohol and stir, soak overnight to make it into a suspension for use. Add 21 parts of the reserved thick paste to 10 parts of polyvinyl alcohol suspension, add 22 parts of glycerol, stir evenly, add 120 parts of 60% ethanol to make the total weight to 142 parts, stir evenly, and divide into packages to obtain the product.

[0153] The medicinal effects are the same as those of the water-extraction and alcohol-precipitation product of Example 1, and will not be repeated here.

[0154] Example 6 Gel Preparation and Stability Study

[0155] Prescription: stir-fried Xanthium sibiricum 20 parts, Kochia scoparia 20 parts, Chuanxiong 20 parts, Carthamus tinctorius 20 parts, Sophora flavescens 10 parts;

[0156] Excipients: 1.4 parts of carbomer homopolymer type C, 20 parts of glycerin, 0.14 parts of sodium propylparaben, 4 parts of triethanolamine, and appropriate amount of purified water.

[0157] Preparation method: Add water to the above five flavors and boil them twice. For the first time, add 10 times the amount of water to soak for 30 minutes and then boil for 2 hours. For the second time, add 8 times the amount of water and boil for 1 hour. Combine the decoctions, filter through 200 mesh, and concentrate the filtrate at 60℃~65℃ under reduced pressure (-0.08MPa~-0.10MPa) to a clear paste with a relative density of 1.10~1.15 (measured at 60℃). Cool to room temperature, add ethanol to make the supernatant contain 60% alcohol, precipitate with alcohol for 16 hours, filter through 300 mesh, and concentrate the filtrate at 50℃~70℃ under reduced pressure (-0.08MPa~-0.10MPa) to a thick paste with a relative density of 1.25~1.35 (measured at 50℃), and set aside.

[0158] Weigh 0.14 parts of propylparaben sodium and add it to a batching tank containing 86 parts of purified water, stir to dissolve, add 1.4 parts of carbomer homopolymer C and stir slightly, soak overnight to make it into a suspension for standby use. Add 22 parts of the reserved thick paste to the carbomer homopolymer C suspension, add 20 parts of glycerol, stir evenly, add an appropriate amount of triethanolamine (about 4 parts) to adjust the pH value to 6.5-7.5, stir evenly, add an appropriate amount of purified water to make the total weight to 142 parts, stir evenly, and pack.

[0159] The medicinal effects are the same as those of the water-extraction and alcohol-precipitation product of Example 1, and will not be repeated here.

[0160] The above is a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field, within the technical scope disclosed by the present invention, can make equivalent replacements or changes according to the technical solutions and concepts of the present invention, which should be covered by the protection scope of the claims of the present invention.

Claims

1. A Chinese medicine external preparation for dispelling wind and relieving itching, characterized in that: The Chinese medicine external preparation is composed of the following raw materials by weight: 10-30 parts of stir-fried Xanthium sibiricum, 10-30 parts of Kochia scoparia, 10-30 parts of Chuanxiong, 10-30 parts of Carthamus tinctorius, and 5-15 parts of Sophora flavescens; the extraction process is selected from any one of the following: Method 1: Add water to stir-fried Xanthium sibiricum, Kochia scoparia, Chuanxiong, Carthamus tinctorius, and Sophora flavescens according to the above proportions for 2-3 times, take the supernatant, filter, and concentrate the filtrate to a clear paste of 1.20-1.35 to obtain the product; Method 2: The extraction process is as follows: stir-fry Xanthium sibiricum, Kochia scoparia, Chuanxiong, Carthamus tinctorius, and Sophora flavescens with water for 2-3 times according to the above proportions, concentrate the extract to a relative density of 1.10-1.25, add alcohol to an alcohol content of 60%-75%, precipitate with alcohol for 12-20 hours, take the supernatant, filter, and concentrate the alcohol filtrate under reduced pressure to a clear paste with a relative density of 1.20-1.35 to obtain the product; Method 3: Add stir-fried Xanthium sibiricum, Kochia scoparia, Ligusticum chuanxiong, Carthamus tinctorius and Sophora flavescens in the above proportions, use 30%-80% ethanol as the extraction solution, extract for 18h-48h, take the extract and concentrate it under reduced pressure to obtain the product.

2. The Chinese medicine external preparation for dispelling wind and relieving itching according to claim 1, characterized in that: The traditional Chinese medicine external preparation is composed of the following medicinal raw materials: 20 parts of stir-fried Xanthium sibiricum fruit, 20 parts of Kochia scoparia fruit, 20 parts of Chuanxiong rhizome, 20 parts of Carthamus tinctorius, and 10 parts of Sophora flavescens.

3. The Chinese medicine external preparation for dispelling wind and relieving itching according to claim 1, characterized in that: The traditional Chinese medicine external preparation is composed of the following medicinal raw materials: 18 parts of stir-fried Xanthium sibiricum fruit, 19 parts of Kochia scoparia fruit, 20 parts of Chuanxiong rhizome, 21 parts of safflower, and 12 parts of Sophora flavescens.

4. The Chinese medicinal external preparation for dispelling wind and relieving itching according to claim 1, characterized in that: The traditional Chinese medicine external preparation is composed of the following medicinal raw materials: 19 parts of stir-fried Xanthium sibiricum fruit, 20 parts of Kochia scoparia fruit, 18 parts of Chuanxiong rhizome, 19 parts of Carthamus tinctorius, and 11 parts of Sophora flavescens.

5. The Chinese medicinal external preparation for dispelling wind and relieving itching according to any one of claims 1 to 4, characterized in that: The traditional Chinese medicine external preparation includes a gel, cream, solution or film-coating made of pharmaceutically acceptable excipients.

6. The Chinese medicinal external preparation for dispelling wind and relieving itching according to claim 5, characterized in that: The external Chinese medicine preparation is a gel, which comprises, by weight, 20-100 parts of the product according to any one of claims 1 to 5, 0.1-2.0 parts of carbomer, 0.1-0.2 parts of sodium propylparaben, 10-30 parts of glycerol, 130-150 parts of water, and triethanolamine to adjust the pH to 6.0-8.

0.

7. The Chinese medicinal external preparation for dispelling wind and relieving itching according to claim 5, characterized in that: The external Chinese medicine preparation is a solution, which comprises 20-40 parts of the product according to any one of claims 1 to 5, 50-80 parts of water, 10-30 parts of glycerol, 0.1-0.5 parts of disodium edetate, and 0.1-0.5 parts of tartaric acid.

8. The Chinese medicinal external preparation for dispelling wind and relieving itching according to claim 5, characterized in that: The traditional Chinese medicine external preparation is a coating agent, which comprises 20-35 parts of the product according to any one of claims 1 to 5, 5-15 parts of polyvinyl alcohol, 0.2-0.8 parts of sodium propylparaben, 10-30 parts of glycerol, and 120-150 parts of 50%-60% ethanol solution.

9. Use of the Chinese medicinal preparation for external use according to any one of claims 1 to 8 in the preparation of a medicament for treating urticaria, eczema, urticaria, allergic dermatitis, rhinitis and other pruritus-induced pruritic diseases.

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