An external traditional Chinese medicine composition with the effects of dispelling wind and dampness, promoting blood circulation and relieving itching

Abstract

The application discloses a kind of external use traditional Chinese medicine compositions with expelling wind and removing dampness, activating blood and stopping itching effect, by weight parts, including: 10-20 parts of Xanthium sibiricum, 10-20 parts of Xanthium sibiricum, 10-20 parts of Lemna, 10-20 parts of Smilax china, 10-20 parts of Arnebia, 25-35 parts of Salvia miltiorrhiza, 10-20 parts of Angelica sinensis.Efficacy experiment proves that the composition itself has the effect of significant antipruritic, anti-inflammatory and repairing skin barrier, its mechanism of action is related to regulating Th1 / Th2 immune balance, reducing the content of Th2 type inflammatory factor IL-4 in skin tissue.Clinical trials further show that, on the basis of conventional treatment, combined use of the composition can significantly reduce the pruritus score and lesion severity score of patients with various pruritic skin diseases, and improve the quality of life of patients, the total effective rate can reach 93.90% after 14 days of treatment, and it has no irritancy to intact and damaged skin, and has good safety.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine formulation technology, and in particular to a topical traditional Chinese medicine composition with the effects of dispelling wind and dampness, promoting blood circulation and relieving itching. Background Technology

[0002] As the largest organ and the first line of defense for health, the skin is susceptible to various skin diseases when its function is impaired. Itching is the most common symptom of many skin diseases, causing not only discomfort but also problems with sleep, mood, and social interactions, severely impacting daily activities and mental health, and reducing quality of life. Itching encompasses various specific diseases, such as pruritus, eczema, urticaria, psoriasis, and neurodermatitis. Its etiology is complex, often related to factors such as wind-dampness-heat and qi-blood disharmony. Some diseases are characterized by recurrent attacks and difficulty in complete cure. Prolonged illnesses often present with complex syndromes such as "prolonged illness affecting the collaterals," "blood deficiency and wind-dryness," or "wind-dampness-heat and blood stasis," severely affecting patients' quality of life. In current treatment methods, Western medicine often uses antihistamines and corticosteroids for symptomatic relief. While these can temporarily alleviate symptoms, long-term use carries the risk of side effects, and relapse is common after discontinuation.

[0003] Traditional Chinese medicine (TCM) considers these diseases to fall under the categories of "wind-induced itching," "damp sores," and "stubborn tinea," with their pathogenesis often related to the interplay of "wind," "dampness," "heat," "toxins," and "blood stasis" in the skin's texture. The important treatment principle is "treat wind by first treating blood; when blood flows smoothly, wind will naturally subside." Therefore, dispelling wind and dampness, detoxifying and relieving itching, nourishing and invigorating blood, and resolving blood stasis and unblocking the meridians are the core principles for treating these diseases. Currently, although various TCM preparations are used to treat these diseases, they mostly focus on "clearing heat and drying dampness," lacking sufficient power to dispel wind, invigorate blood, and nourish blood.

[0004] Therefore, developing a topical Chinese medicine compound preparation that is rigorously formulated, has definite efficacy, is easy to prepare, and is safe and convenient to use remains an urgent clinical need. Summary of the Invention

[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing a topical traditional Chinese medicine composition that has the effects of dispelling wind and dampness, promoting blood circulation, and relieving itching.

[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: The first aspect is to provide a topical Chinese medicine composition with the effects of dispelling wind and dampness, promoting blood circulation and relieving itching, which, by weight, includes: 10-20 parts of Xanthium sibiricum, 10-20 parts of Xanthium sibiricum fruit, 10-20 parts of Spirodela polyrhiza, 10-20 parts of Smilax china, 10-20 parts of Lithospermum erythrorhizon, 25-35 parts of Salvia miltiorrhiza, and 10-20 parts of Angelica sinensis.

[0007] Further, by weight, the traditional Chinese medicine composition includes: 12-18 parts of Xanthium sibiricum, 12-18 parts of Xanthium sibiricum fruit, 12-18 parts of Spirodela polyrhiza, 12-18 parts of Smilax china, 12-18 parts of Lithospermum erythrorhizon, 28-32 parts of Salvia miltiorrhiza, and 12-18 parts of Angelica sinensis.

[0008] Furthermore, by weight, the traditional Chinese medicine composition comprises: 15 parts of Xanthium sibiricum, 15 parts of Xanthium sibiricum fruit, 15 parts of Spirodela polyrhiza, 15 parts of Smilax china, 15 parts of Lithospermum erythrorhizon, 30 parts of Salvia miltiorrhiza, and 15 parts of Angelica sinensis.

[0009] The second aspect is to provide a method for preparing the above-mentioned topical traditional Chinese medicine composition. When the dosage form of the traditional Chinese medicine composition is topical granules, the preparation method includes the following steps: Step 1: Extract the volatile oil and extract the alcohol from Angelica sinensis separately: Take the prescribed amount of Angelica sinensis, crush it, soak it in water, extract the volatile oil by steam distillation, collect the volatile oil, dissolve and dilute it with ethanol, and keep it for later use, while retaining the residue; Take the prescribed amount of Lithospermum erythrorhizon and Salvia miltiorrhiza, add ethanol and heat under reflux to extract, combine the alcohol extracts, filter, recover the ethanol and concentrate it for later use, while retaining the residue. Step 2, water extraction: Take the prescribed amount of cocklebur grass, cocklebur fruit, duckweed, and smilax. After the cocklebur fruit is stir-fried to reduce its toxicity, combine it with all the dregs obtained in Step 1, soak it in water, decoct it, combine the decoctions, and filter it. Step 3, purification and drying: After concentrating the aqueous extract obtained in step 2, add ethanol for alcohol precipitation, let stand, filter, recover the ethanol and concentrate, combine with the concentrated alcohol extract obtained in step 1, continue to concentrate into a clear paste, dry, pulverize, and obtain dry paste powder. Step 4, Granulation: Take the dry powder obtained in Step 3 and mix it with the excipients. Use the ethanol solution containing Angelica sinensis volatile oil obtained in Step 1 as a wetting agent to make a soft material, granulate it, dry it, and granulate it to obtain the final product.

[0010] Furthermore, when the dosage form of the traditional Chinese medicine composition is a topical ointment, the preparation method includes: mixing and emulsifying the dry ointment powder with oil and water phase components, cooling, adding the Angelica sinensis volatile oil, stirring evenly, and cooling to obtain the final product.

[0011] The third aspect is to provide the application of the above-mentioned topical Chinese medicine composition in the preparation of topical medicines for treating pruritus skin diseases.

[0012] Furthermore, the pruritic skin disease is any one or more of eczema, pruritus, atopic dermatitis, seborrheic dermatitis, or contact dermatitis.

[0013] Furthermore, the dosage form of the topical medicine is a topical granule, topical ointment, lotion, cream, gel, or liniment.

[0014] The occurrence of intractable pruritic skin diseases is mostly due to external invasion of wind, dampness, and heat, or internal accumulation of dampness and heat, with dampness and heat clashing and stagnating in the skin. Over time, this leads to obstruction of meridians, stagnation of qi and blood, and lack of nourishment for the skin, resulting in wheals, erythema, thickening, desquamation, and intense itching. The disease is located on the surface, and its core pathogenesis lies in "wind, dampness, heat, stagnation, and blood deficiency leading to malnourishment." Therefore, treatment should not only focus on dispelling wind and dampness, clearing heat and detoxifying to address the symptoms, but also on nourishing blood, promoting blood circulation, and removing blood stasis to address the root cause, so that qi and blood flow smoothly, wind pathogens are eliminated, and the skin is nourished.

[0015] Based on the above pathogenesis, the compatibility principles and formula explanations of the traditional Chinese medicine compound provided by this invention are as follows: The principal herbs in this formula are cocklebur grass and cocklebur fruit. These two herbs, from the same plant, have similar effects, but one is cold and the other warm. Cocklebur grass is bitter, pungent, cold, and toxic; it excels at dispelling wind and heat, detoxifying, and killing parasites. Cocklebur fruit is sweet, warm, and toxic; it functions to dispel wind and dampness, kill parasites, and relieve itching. The *Yuqiu Yaoxie* states: "It reduces swelling and relieves numbness, dispels wind and dampness. It treats scabies, wind-induced itching, and rashes." Together, they dispel wind, eliminate dampness, and relieve itching, targeting the pathogenic factors of wind and dampness, opening the gates to expel the invaders, making them essential herbs for treating itching.

[0016] The assistant herbs are duckweed and smilax. Duckweed is pungent and cold, and is good at dispersing wind-heat, promoting rash eruption and relieving itching; smilax is sweet and warm, and can dispel wind, promote diuresis and detoxify. The two herbs assist the principal herbs in dispelling wind, promoting diuresis, detoxifying and relieving itching.

[0017] The adjuvant herbs are Lithospermum erythrorhizon, Salvia miltiorrhiza, and Angelica sinensis. Lithospermum erythrorhizon is bitter and cold, and is good at cooling blood, promoting blood circulation, relieving rashes, detoxifying, and clearing heat toxins from the blood. Salvia miltiorrhiza is bitter and slightly cold, and its function is to promote blood circulation, nourish blood, cool blood, and detoxify. As the saying goes, "Treat wind by first treating blood, and when blood flows smoothly, wind will naturally disappear." Angelica sinensis is sweet, pungent, and warm, and it nourishes and harmonizes blood. The Rihuazi Materia Medica says, "It treats all kinds of wind, all kinds of blood, and nourishes all kinds of fatigue." If urticaria is chronic and does not heal, it must be due to damage to yin and blood. It is used to support the body's resistance and expel pathogens.

[0018] When used in combination, this formula works synergistically to dispel wind and dampness, nourish and invigorate blood, and detoxify and relieve itching. It expels external wind pathogens, clears internal damp-heat, and harmonizes and nourishes the blood, thus resolving wind-dampness-heat toxins, harmonizing qi and blood, and nourishing the skin. Consequently, symptoms such as itching, hives, erythema, and thickening naturally disappear. This formula aligns with the pathogenesis of pruritic skin diseases, which involves the accumulation of wind-dampness toxins and disharmony of yin and blood.

[0019] The present invention adopts the above technical solution and has the following technical effects compared with the prior art: This invention relates to a specific herbal composition, composed of Xanthium sibiricum, Xanthium fruit, Spirodela polyrhiza, Smilax china, Lithospermum erythrorhizon, Salvia miltiorrhiza, and Angelica sinensis in a specific ratio. Pharmacodynamic experiments have confirmed that this composition itself has significant antipruritic, anti-inflammatory, and skin barrier repair effects. Its mechanism of action is related to regulating the Th1 / Th2 immune balance and reducing the content of the Th2-type inflammatory factor IL-4 in skin tissue. Clinical trials have further shown that, when used in combination with conventional treatment, this composition can significantly reduce pruritus scores and skin lesion severity scores in patients with various pruritic skin diseases, and improve patients' quality of life. The total effective rate after 14 days of treatment can reach 93.90%, and it is non-irritating to both intact and damaged skin, demonstrating good safety. Attached Figure Description

[0020] Figure 1 HE staining of skin in AEW model mice: A. blank control group; B. model group; C. low-dose group; D. medium-dose group; E. high-dose group; F. positive control group. Detailed Implementation

[0021] The present invention will be further described below with reference to the accompanying drawings and specific embodiments, but this is not intended to limit the invention. It should be noted that, unless otherwise specified, the embodiments and features described in the embodiments of the present invention can be combined with each other.

[0022] Experimental methods in the following examples, unless otherwise specified, were performed under standard conditions or as recommended by the manufacturer. Unless otherwise stated, all reagents and materials used in the following examples were commercially available.

[0023] Example 1 This embodiment provides a topical Chinese medicine composition with the effects of dispelling wind and dampness, promoting blood circulation and relieving itching. By mass, it consists of the following components: 15 parts of Xanthium sibiricum, 15 parts of Xanthium sibiricum fruit, 15 parts of Spirodela polyrhiza, 15 parts of Smilax china, 15 parts of Lithospermum erythrorhizon, 30 parts of Salvia miltiorrhiza, and 15 parts of Angelica sinensis.

[0024] Example 2 Preparation of external granules (1) Extraction of Angelica sinensis volatile oil: Weigh Angelica sinensis according to the prescription ratio of Example 1, crush it through a 10-mesh sieve, add 12 times the amount of water, soak for 4 hours, extract by steam distillation for about 8 hours, collect the volatile oil, dissolve and dilute with an appropriate amount of 95% ethanol, and keep the residue.

[0025] (2) Alcohol extraction: Weigh out Lithospermum erythrorhizon and Salvia miltiorrhiza according to the prescription ratio in Example 1, add 6 to 8 times the amount of 75% ethanol, heat and reflux to extract twice, each time for 1.5 hours, combine the alcohol extracts, filter, and recover the ethanol from the filtrate under reduced pressure until there is no alcohol taste, concentrate to an appropriate amount, and keep for later use; retain the residue.

[0026] (3) Water extraction: Weigh out the following ingredients according to the prescription ratio in Example 1: Xanthium sibiricum, Xanthium sibiricum fruit, duckweed, and Smilax china. After stir-frying Xanthium sibiricum to reduce its toxicity, combine it with Xanthium sibiricum, duckweed, Smilax china, Angelica sinensis residue, Lithospermum erythrorhizon residue, and Salvia miltiorrhiza residue. Add 10 times the amount of water, soak for 0.5 hours, and decoct twice, each time for 1 to 2 hours (the first time is slightly longer). Combine the decoctions and filter.

[0027] (4) Purification and merging: Concentrate the aqueous extract under reduced pressure to a relative density of 1.05~1.10 (60℃), slowly add 95% ethanol to make the alcohol content reach 65%, let stand for 24 hours, filter, and recover the ethanol from the filtrate under reduced pressure until there is no alcohol odor, and continue to concentrate to an appropriate amount; merge with the alcohol extract concentrate obtained in step (2), and concentrate under reduced pressure to a clear paste with a relative density of 1.25~1.30 (60℃); place the clear paste in a vacuum drying oven and dry it to a dry paste at 65℃ and -0.09MPa, take it out and crush it through a 100-mesh sieve to obtain dry paste powder.

[0028] (5) Granulation: Take dry ointment powder and mix it with appropriate amounts of dextrin, starch and other excipients. Use the ethanol solution of Angelica sinensis volatile oil as a wetting agent to make soft material. Sieve and granulate, dry and granulate, then seal and package to obtain external granules for medicinal bath or wet compress.

[0029] Example 3 Preparation of Topical Ointment (1) Prepare the Chinese herbal dry extract powder and Angelica sinensis volatile oil according to (1)~(4) of the above granule preparation method; (2) Emulsification: Glycerin, Tween-80, purified water and Chinese herbal dry powder are used as the aqueous phase and heated to 75°C in a beaker; stearic acid, glyceryl monostearate, white petrolatum, octadecanol and liquid paraffin are used as the oil phase and heated to 75°C in another beaker to melt; the aqueous phase is slowly added to the oil phase under stirring and emulsified at a speed of 250 r / min for 15 minutes.

[0030] (3) Adding the medicine and cooling: When the temperature of the emulsion system drops to 45°C, add the volatile oil of Angelica sinensis, continue to stir evenly, stop heating, and continue stirring at room temperature until it is completely cooled and solidified. Dispense the ointment into aluminum ointment tubes, seal them, and the topical ointment is obtained.

[0031] Test Example 1: Skin Irritation Test The study was conducted in accordance with the "Technical Guidelines for Research on Local Irritation and Allergic Effects of Traditional Chinese Medicine and Natural Drugs".

[0032] 1. Experimental Methods Six healthy New Zealand rabbits were used, divided into an intact skin group and a damaged skin group. The test drugs were the granules (5% solution, for wet compresses) prepared in Example 2 and the ointment (for direct application) prepared in Example 3. A self-comparison method was used, with the right side receiving either the granules or the ointment, and the left side receiving a negative control (purified water). Administered once daily for 7 consecutive days, at a dose of 0.5 mL (g) per rabbit. Skin irritation was observed before daily administration and 1 hour after drug removal. After the last administration, erythema and edema were visually observed and recorded at the application site at 60 minutes, 24, 48, and 72 hours after drug removal. Scoring was performed according to the Draize skin irritation rating scale (Table 1).

[0033] Table 1

[0034] 2. Experimental Results (1) Intact skin: After 7 days of continuous administration, no irritation reactions such as erythema, edema, or eschar were observed on the back skin of rabbits in the granule group, ointment group and negative control group. The average score of the irritation reaction was 0, which was judged as non-irritating.

[0035] (2) Damaged skin: No erythema, edema or other reactions were observed in the granule group and ointment group at the site of damaged skin (only one animal in the granule group showed mild erythema at 1 hour, with a score of 1 point, which subsided after 24 hours), with an average score of <0.5, and was judged to be non-irritating.

[0036] (3) Whole body observation: During the experiment, all animals had normal diet, activity and mental state, no abnormal behavior, and no abnormal changes such as infection, hair loss or pigmentation were observed at the drug administration site.

[0037] 3. Experimental Conclusions The topical granules and ointments of this invention are non-irritating to both intact and broken skin in rabbits, exhibiting good safety profiles. They are suitable for topical treatment of skin diseases, including application to areas of broken skin.

[0038] Experimental Example 2: Clinical Trial (Loading Experiment for Common Pruritus-Induced Skin Diseases with Blood Deficiency and Wind-Dryness Syndrome) 1. General Information This study included 82 patients with common pruritic skin conditions, all of whom visited the Department of Traditional Chinese Medicine at Shanghai Changzheng Hospital between October 2025 and March 2026. There were 42 males and 40 females, aged 18–75 years, with a mean age of 42.6 ± 14.2 years. The diseases included: eczema (30 cases), pruritus (20 cases), atopic dermatitis (12 cases), seborrheic dermatitis (10 cases), and contact dermatitis (10 cases).

[0039] All patients met the corresponding Western medicine diagnostic criteria and were diagnosed with blood deficiency and wind-dryness syndrome by traditional Chinese medicine.

[0040] 2. Diagnostic criteria 2.1 Western Medicine Diagnostic Criteria: ① Eczema: Refer to the diagnostic criteria for eczema in "Dermatology and Venereology (7th Edition)"; ② Pruritus: Refer to the diagnostic criteria in "Expert Consensus on Traditional Chinese Medicine Treatment of Pruritus" (no primary skin lesions, only itching and secondary scratch marks); ③ Atopic dermatitis: Use the Williams diagnostic criteria; ④ Seborrheic dermatitis: Refer to the diagnostic criteria in "Expert Consensus on the Diagnosis and Treatment of Seborrheic Dermatitis in Traditional Chinese and Western Medicine"; ⑤ Contact dermatitis: Refer to the diagnostic criteria for contact dermatitis in "Merck Manual".

[0041] 2.2 Traditional Chinese Medicine Diagnostic Criteria: ① Primary Symptoms: Dry, scaly, rough, thickened, or lichenified skin; severe itching, worsening at night; ② Secondary Symptoms: Pale or sallow complexion; dizziness; palpitations; insomnia; fatigue; dry mouth and throat; constipation; ③ Tongue and Pulse: Pale red or pale white tongue with little or no coating; thready or deep and thready pulse. The syndrome type is determined by a senior, experienced TCM physician: Patients meeting two primary symptoms and two secondary symptoms, with generally consistent tongue and pulse characteristics, are eligible for selection.

[0042] 3. Inclusion criteria ① Meets the above Western medicine diagnosis; ② Belongs to the TCM syndrome differentiation criteria of blood deficiency and wind dryness; ③ Has not used any related medications for treating pruritus in the past 2 weeks; ④ Has good compliance, and the patient has given informed consent and voluntarily signed the informed consent form.

[0043] 4. Exclusion Criteria ① Individuals allergic to any component of the investigational drug; ② Individuals with severe bacterial, fungal, or viral infections at the site of skin lesions, or those with open ulcers; ③ Pregnant or lactating women; ④ Individuals with severe dysfunction of organs such as the heart, liver, or kidneys; ⑤ Individuals with mental illness or poor compliance; ⑥ Individuals who have participated in other clinical trials within the past 3 months.

[0044] 5. Intervention Program (1) Standardized Western medicine basic treatment: Eczema: Apply mometasone furoate cream topically once a day, thinly applied to the affected area; take loratadine tablets orally once a day. Pruritus: Apply urea ointment topically twice a day; take loratadine tablets orally once a day. Atopic dermatitis: Apply hydrocortisone butyrate cream topically once a day; take cetirizine tablets orally once a day. Seborrheic dermatitis: Apply ketoconazole cream topically once a day; take loratadine tablets orally once a day. Contact dermatitis: Apply mometasone furoate cream topically once a day; take loratadine tablets orally once a day.

[0045] (2) Traditional Chinese medicine external treatment (additional treatment): On the basis of the above basic treatment, the external granules prepared in Example 2 of this invention are added.

[0046] Instructions for use: Take one packet (45g) each time, place it in a basin, dissolve it with 500-1000ml of boiling water, and let it cool to 38-42℃. Use it to soak, apply wet compresses or rinse the affected area for 15-20 minutes, twice a day (once in the morning and once in the evening), for 14 consecutive days.

[0047] (3) Regulations on combined medication: No other traditional Chinese medicine preparations, decoctions or external application of traditional Chinese medicine preparations shall be used during the treatment period. If other medications must be used due to the condition, they shall be recorded in detail.

[0048] 6. Observe the course of treatment The efficacy was evaluated at three time points: before treatment (baseline), 7 days after treatment, and 14 days after treatment.

[0049] 7. Evaluation Indicators 7.1 Primary therapeutic indicators Itching score: The peak itch numerical rating scale (NRS) was used, ranging from 0 to 10, and patients self-reported the most severe itch in the past 24 hours.

[0050] 7.2 Secondary efficacy endpoints (1) Severity of skin lesions: The Eczema Area and Severity Index (EASI) score was used (for pruritus, EASI only records secondary scratches, scabs, etc., and does not count primary skin lesions).

[0051] (2) Quality of life: Dermatology Quality of Life Index (DLQI) was used for scoring.

[0052] (3) TCM syndrome score: The main symptoms and secondary symptoms are scored (0, 2, 4, 6 points) based on the blood deficiency and wind dryness syndrome grading and quantification table.

[0053] (4) Overall effective rate: The efficacy index was calculated according to the nimodipine method (difference in scores before and after treatment / score before treatment × 100%). Cure: efficacy index ≥ 95%; Significant effect: 70% ≤ efficacy index < 95%; Effective: 30% ≤ efficacy index < 70%; Ineffective: efficacy index < 30%. Overall effective rate = (Cure + Significant effect + Effective) / Total number of cases × 100%.

[0054] 7.3 Safety Indicators Adverse events: Record any adverse events that occur during treatment, including local irritation, allergic reactions, and systemic symptoms.

[0055] 8. Statistical Analysis SPSS 27.0 statistical software was used for data management and analysis. Count data were described using frequency (proportion), and comparisons between groups were performed using... Test. For continuous data that conform to a normal distribution, express the mean ± standard deviation (SD). The description of the data is as follows: Paired-samples t-tests were used for comparisons before and after treatment within each group; for data not conforming to a normal distribution, the median was used, and Wilcoxon signed-rank tests were used for comparisons within each group. All tests were two-tailed. P <0.05 indicates a statistically significant difference.

[0056] 9. Results 9.1 Overall therapeutic effect of the disease Table 2 Comparison of scores before and after overall treatment ( , n =82)

[0057] Table 3 Overall treatment effectiveness analysis ( n =82)

[0058] 9.2 Efficacy of treatment for each disease (14 days of treatment) Table 4 Comparison of NRS pruritus scores before and after treatment for each disease ( )

[0059] Table 5. Overall effective rate of treatment for each disease after 14 days ( n )

[0060] 9.3 Adverse Reactions No adverse events related to the topical formulation of this invention were observed throughout the entire trial. A small number of patients (3 cases, 3.66%) experienced mild local dryness or burning sensations after using basic Western medicine medications (such as mometasone furoate cream), which resolved spontaneously after discontinuation of the medication or reduction of the frequency of use, and were unrelated to the formulation of this invention.

[0061] 9.4 Historical Comparative Analysis Literature reports that a basic treatment regimen using corticosteroids combined with antihistamines for pruritic skin diseases such as eczema and atopic dermatitis has an overall effective rate of approximately 65%–75% after 2 weeks (referencing the "Chinese Guidelines for the Diagnosis and Treatment of Eczema" and relevant clinical studies in recent years). In this trial, the addition of the granules of this invention to the basic treatment regimen resulted in an overall effective rate of 93.90% after 14 days of treatment, significantly superior to the reported efficacy of the basic treatment alone. This historical control analysis suggests that the granules of this invention exert a synergistic effect in the combination regimen.

[0062] 10. Experimental Conclusion Under basic Western medicine treatment, the combined use of the topical granules of this invention has a clear therapeutic effect on various common pruritus skin diseases (eczema, pruritus, atopic dermatitis, seborrheic dermatitis, and contact dermatitis) diagnosed by Traditional Chinese Medicine (TCM) as blood deficiency and wind-dryness syndrome. After 14 days of treatment, patients' NRS scores, EASI scores, DLQI scores, and TCM syndrome scores all decreased significantly, with a total effective rate of 93.90%, significantly better than the effects of basic treatment alone reported in the literature. No adverse reactions related to the preparation of this invention were observed throughout the entire course of treatment, indicating good safety.

[0063] Example 3: Pharmacodynamic Test 1. Experimental Objective The purpose of this invention is to evaluate the antipruritic, anti-inflammatory, and skin barrier repair effects of the topical granules on a mouse model of chronic pruritus, providing pharmacodynamic evidence for its clinical application in the treatment of chronic pruritus skin diseases.

[0064] 2. Experimental Materials 2.1 Test Drug The granule group of the present invention (low, medium and high doses): Take the external granules prepared in Example 2, and prepare them into 2.5%, 5% and 10% (g / ml, based on the amount of raw drug) solutions with purified water before use, and perform AEW modeling.

[0065] Positive control group: 0.1% mometasone furoate cream, specification: 5g, each tube contains 5mg mometasone furoate, AEW modeling.

[0066] Model control group: Equal volume of purified water, AEW modeling.

[0067] Blank control group: Equal volume of purified water, normal mice.

[0068] 2.2 Laboratory Animals Forty-eight SPF-grade male BALB / c mice, 6-8 weeks old, weighing 18-22g, were selected. The mice were housed at a temperature of 22±2℃, relative humidity of 50%-60%, with 12-hour light-dark cycles and free access to food and water. Experiments began after one week of acclimatization. The experimental protocol was approved by the institution's laboratory animal ethics committee.

[0069] 3. Experimental Methods 3.1 Modeling and Drug Administration Forty-eight BALB / c mice were acclimatized for one week and then randomly divided into four groups (n=8 per group): a control group, a model group, low-, medium-, and high-dose groups of the drug, and a positive control group, based on body weight using a random number table. The pruritus model was established according to the literature. On day 0, a 2 cm × 3 cm hairless area was prepared on the back of the neck of the mice. Starting from day 1, cotton balls were soaked in an acetone-ether mixture (1:1) and applied to the shaved area on the back of the neck of the mice at 9:00 AM daily for 15 seconds, followed by a wet compress of pure water for 30 seconds. The control group received pure water applied to the skin once daily for 7 consecutive days. After successful model establishment, starting from day 8, 0.2 ml of the corresponding test drug solution was taken from each treatment group and evenly applied to the shaved area on the back of the neck at 10:00 AM and 4:00 PM daily. The area was then covered and fixed with a non-toxic polyethylene film and left for 0.5 hours before being washed off with warm water. This was repeated once daily for 7 consecutive days. The positive control group applied 0.2g of mometasone furoate cream daily. The blank control group and the model control group applied an equal volume of purified water.

[0070] 3.2 Observation Indicators (1) Observation of pruritus behavior: Scratching behavior was recorded before administration (day 8) and on days 1, 3, 5, and 7 after administration (i.e., days 9, 11, 13, and 15 of the experiment). Mice were placed in a transparent observation cage (20 cm in diameter and 30 cm in height) for 30 minutes to acclimatize. They were then filmed continuously for 0.5 h in a quiet, undisturbed environment. The behavior of the mice scratching their backs with their hind limbs was recorded using a camera. (Scratching: one continuous scratching of the back with the hind limbs of the mouse was counted as one instance. A pause of less than 2 seconds in the middle of continuous scratching was considered as the same instance).

[0071] (2) Skin tissue pathological examination: After the administration of the drug (day 15), the mice were sacrificed and full-thickness skin (about 1cm × 1cm) was taken from the central part of the hairless area on the back. Some tissues were fixed in 4% paraformaldehyde, embedded in paraffin, sectioned, and stained with HE to observe the epidermal thickness and the degree of inflammatory cell infiltration.

[0072] (3) Evaluation of skin barrier function: Using a Tewameter TM300, the TEWL value of the skin on the back of mice was measured before administration and on days 3 and 7 after administration in a stable environment with room temperature (23±1)℃ and humidity (46±2)%. Three points were measured for each mouse and the average value was taken.

[0073] (4) Determination of inflammatory factors in skin tissue: Take another part of skin tissue, cut it into pieces, add PBS homogenate, centrifuge and take the supernatant, and use an ELISA kit to detect the content of interleukin-4 (IL-4) and interferon-γ (IFN-γ).

[0074] 4. Experimental Results 4.1 Effects on pruritus in mice Compared with the blank control group, the number of scratches in the model control group mice was significantly increased, indicating that the AEW model was successfully established. Compared with the model control group, the number of scratches in the medium and high dose groups of the granules of this invention was significantly reduced from the 3rd day after administration, and the effect of the high dose group was comparable to that of the positive control group. The low dose group also showed a significant inhibitory effect after the 5th day. The results indicate that the granules of this invention have a dose-dependent antipruritic effect on chronic pruritus.

[0075] Table 6. Effect of the granules of this invention on the number of scratches in AEW model mice ( , n =10)

[0076] Note: Compared with the blank control group, ### P <0.001; compared with the model control group, * P< 0.05, ** P< 0.01, *** P< 0.001.

[0077] 4.2 Effects on dermatopathology In the control group, the skin structure on the back of the neck of mice was relatively intact, with no thickening of the stratum corneum, a flat epidermis, and no obvious telangiectasia or inflammatory cell infiltration in the dermis. In the model group, the epidermis of the skin of mice was significantly thickened (hyperkeratosis and acanthosis), and the dermis showed telangiectasia, congestion, and extensive inflammatory cell infiltration. Compared with the model control group, the epidermal thickness was significantly reduced in the medium and high dose groups of the granules of this invention, with only a small amount of telangiectasia in the dermis, a significantly reduced degree of inflammatory cell infiltration, and the skin structure tended to be normal. The positive control group also showed similar improvement. See also Figure 1 .

[0078] 4.3 Effects on skin barrier function The transepidermal water loss (TEWL) value of the dorsal skin of mice in the model control group was significantly higher than that in the blank control group, indicating that the skin barrier was damaged. After 7 days of administration of the medium and high dose groups of the granules of this invention, the TEWL value was significantly reduced, approaching the level of the blank control group, suggesting that the formulation of this invention can effectively repair the damaged skin barrier.

[0079] Table 7. Effects of the granules of this invention on the TEWL value of skin in AEW model mice ( , n =10, g·h -1 ·m -2 )

[0080] Note: Compared with the blank control group, ### P <0.001; compared with the model control group, *P< 0.05, ** P< 0.01, *** P< 0.001.

[0081] 4.4 Effects on skin tissue inflammatory factors IL-4 and IFN-γ In the control group of mice, the levels of Th2 cytokine IL-4 in skin tissue were significantly increased, while the levels of Th1 cytokine IFN-γ were slightly decreased, indicating that the model exhibited a Th2-dominant immune response. The medium and high doses of the granules in this invention significantly reduced IL-4 levels while increasing IFN-γ levels, indicating that it has a regulatory effect on the Th1 / Th2 immune balance.

[0082] Table 8

[0083] Note: Compared with the blank control group, # P <0.05, ### P <0.001; compared with the model control group, * P< 0.05, ** P< 0.01, *** P< 0.001.

[0084] 5. Experimental Conclusion: The topical granules of this invention can dose-dependently reduce the number of scratches in AEW chronic pruritus model mice, inhibit epidermal thickening and inflammatory infiltration, repair skin barrier function, significantly reduce the content of Th2-type inflammatory factor IL-4 in skin tissue, increase the content of Th1-type factor IFN-γ, and restore Th1 / Th2 immune balance. This indicates that the topical granules of this invention have good antipruritic, anti-inflammatory, and skin repair effects.

[0085] Typical Cases To more intuitively demonstrate the technical effects of the present invention, the following three typical cases are provided.

[0086] Case 1: Chronic eczema (blood deficiency and wind-dryness syndrome) Patient Li, female, 52 years old. Presented with a one-year history of "dry, scaly, thickened skin on both lower limbs accompanied by severe itching, worsening over the past week." One year ago, without any obvious cause, the patient developed dry, scaly, thickened skin on the anterior tibia of both lower limbs, resembling lichenification, accompanied by severe itching, especially at night, affecting sleep. She was previously diagnosed with "chronic eczema" at another hospital and intermittently used topical corticosteroid ointment (specific details unknown). Symptoms were temporarily relieved during medication, but quickly recurred after discontinuation. Over the past week, the itching has worsened, with scratches and scabs visible after scratching, and significant dryness and desquamation of the skin. Physical examination revealed symmetrical patches of thickened, lichenified skin on the anterior tibia of both lower limbs, with dry, scaly surfaces, scattered scratches and scabs, covering approximately 3% of the body surface area. The tongue was pale red with little coating, and the pulse was thready. Western medicine diagnosis: Chronic eczema. Traditional Chinese Medicine (TCM) diagnosis: Blood deficiency and wind-dryness syndrome (Main symptoms: dry, scaly, thickened skin, severe itching, worsening at night; Secondary symptoms: dry mouth and throat, palpitations, insomnia, fatigue; Tongue and pulse: pale red tongue with little coating, thready pulse). Treatment plan: Use the topical granules prepared in Example 2 of this invention, one sachet (45g) each time, dissolved in 800ml of boiling water, cooled to 38-42℃, and used to soak the affected area for 20 minutes, twice daily. Simultaneously discontinue the original corticosteroid ointment; only use petroleum jelly moisturizer (twice daily) during treatment. Treatment results: After 7 days of treatment, the pruritus NRS score decreased from 8 to 3, the skin lesion color lightened, desquamation decreased, and sleep improved; after 14 days of treatment, the pruritus NRS score decreased to 1, the skin lesions were basically healed with only a small amount of pigmentation remaining, and the quality of life returned to normal. No recurrence was observed during a 4-week follow-up, indicating that the preparation of this invention has good effects in nourishing blood, promoting blood circulation, dispelling wind, and relieving itching.

[0087] Case 2: Chronic urticaria (a syndrome of wind-dampness toxin accumulation and yin-blood disharmony) Patient Zhang, female, 38 years old. Presented with "recurrent wheals and itching all over the body for over 3 years, worsening in the past week." Previously diagnosed with "chronic urticaria," oral antihistamines such as cetirizine and loratadine provided temporary relief, but the symptoms recurred upon discontinuation. Physical examination: Scattered pale red wheals of varying sizes all over the body, some merging into patches; scratch marks, oozing, and crusting were visible on the trunk and limbs; no primary skin rash; dark red tongue with petechiae on the edges, white and slightly greasy coating; thready, slippery, and slightly hesitant pulse. Western medicine diagnosis: chronic urticaria; Traditional Chinese medicine diagnosis: wind-dampness toxin accumulation, yin and blood disharmony. In addition to standard Western medicine basic treatment (oral loratadine 10mg once daily), the topical granules prepared in Example 2 of this invention were added, one sachet (45g) each time, dissolved in 600ml of boiling water, and used to soak the itchy areas of the whole body for 15 minutes, twice daily. After 7 days of treatment, the NRS score for pruritus decreased from 8 to 2, the wheal area decreased by approximately 80%, and the patient was able to sleep for 6 hours at night. After 14 days of treatment, the NRS score for pruritus decreased to 0, the wheals completely subsided, scratch marks healed, pigmentation lightened, and the DLQI score decreased from 12 to 1. No recurrence was observed during a 4-week follow-up, indicating that the granules of this invention have a synergistic effect on basic treatment.

[0088] Case 3: Pruritus (Blood Deficiency and Wind-Dryness Syndrome) Patient Wang, male, 68 years old. Presented with a 5-year history of recurrent dry, itchy skin, worsening over the past 2 months. Previously diagnosed with senile pruritus, oral antihistamines and topical emollients provided temporary relief but relapse was common. Physical examination revealed dry, scaly skin all over the body, scattered scratches, scabs, and pigmentation on the lower limbs and back, no primary skin rash, pale red tongue with a thin white coating and little moisture, and a thready, wiry pulse. Western medicine diagnosis: senile pruritus; Traditional Chinese medicine diagnosis: blood deficiency and wind-dryness syndrome. In addition to standard Western medicine basic treatment (topical urea ointment + oral loratadine for 7 days), the topical granules prepared in Example 2 of this invention were added. One sachet (45g) was dissolved in 600ml of boiling water and used to soak the itchy areas for 15 minutes, twice daily. After 7 days of treatment, the NRS score for pruritus decreased from 7 to 3, and the patient was able to sleep for 5-6 hours at night. After 14 days of treatment, the NRS score for pruritus decreased to 1, dry and scaly skin significantly improved, scratches healed, and the DLQI score decreased from 10 to 1. No significant recurrence of pruritus was observed during a 4-week follow-up, indicating that the granules of this invention have a synergistic effect on basic treatment.

[0089] The above description is merely a preferred embodiment of the present invention and does not limit the implementation and protection scope of the present invention. Those skilled in the art should realize that any equivalent substitutions and obvious changes made based on the content and illustrations of the present invention should be included within the protection scope of the present invention.

Claims

1. A topical traditional Chinese medicine composition with the effects of dispelling wind and dampness, promoting blood circulation and relieving itching, characterized in that, By weight, it includes: 10-20 parts of Xanthium sibiricum, 10-20 parts of Xanthium sibiricum fruit, 10-20 parts of Spirodela polyrhiza, 10-20 parts of Smilax china, 10-20 parts of Lithospermum erythrorhizon, 25-35 parts of Salvia miltiorrhiza, and 10-20 parts of Angelica sinensis.

2. The external application traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises, by weight, 12-18 parts of Xanthium sibiricum, 12-18 parts of Xanthium sibiricum fruit, 12-18 parts of Spirodela polyrhiza, 12-18 parts of Smilax china, 12-18 parts of Lithospermum erythrorhizon, 28-32 parts of Salvia miltiorrhiza, and 12-18 parts of Angelica sinensis.

3. The topical traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition comprises, by weight, 15 parts of Xanthium sibiricum, 15 parts of Xanthium sibiricum fruit, 15 parts of Spirodela polyrhiza, 15 parts of Smilax china, 15 parts of Lithospermum erythrorhizon, 30 parts of Salvia miltiorrhiza, and 15 parts of Angelica sinensis.

4. The method for preparing the external application traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, When the dosage form of the traditional Chinese medicine composition is external granules, the preparation method includes the following steps: Step 1: Extract the volatile oil and extract the alcohol from Angelica sinensis separately: Take the prescribed amount of Angelica sinensis, crush it, soak it in water, extract the volatile oil by steam distillation, collect the volatile oil, dissolve and dilute it with ethanol, and keep it for later use, while retaining the residue; Take the prescribed amount of Lithospermum erythrorhizon and Salvia miltiorrhiza, add ethanol and heat under reflux to extract, combine the alcohol extracts, filter, recover the ethanol and concentrate it for later use, while retaining the residue. Step 2, water extraction: Take the prescribed amount of cocklebur grass, cocklebur fruit, duckweed, and smilax. After the cocklebur fruit is stir-fried to reduce its toxicity, combine it with all the dregs obtained in Step 1, soak it in water, decoct it, combine the decoctions, and filter it. Step 3, purification and drying: After concentrating the aqueous extract obtained in step 2, add ethanol for alcohol precipitation, let stand, filter, recover the ethanol and concentrate, combine with the concentrated alcohol extract obtained in step 1, continue to concentrate into a clear paste, dry, pulverize, and obtain dry paste powder. Step 4, Granulation: Take the dry powder obtained in Step 3 and mix it with the excipients. Use the ethanol solution containing Angelica sinensis volatile oil obtained in Step 1 as a wetting agent to make a soft material, granulate it, dry it, and granulate it to obtain the final product.

5. The preparation method according to claim 4, characterized in that, When the dosage form of the traditional Chinese medicine composition is a topical ointment, the preparation method includes: mixing and emulsifying the dry ointment powder with oil and water phase components, cooling, adding the Angelica sinensis volatile oil, stirring evenly, and cooling to obtain the final product.

6. The use of the topical Chinese medicine composition according to any one of claims 1-3 in the preparation of a topical medicine for treating pruritic skin diseases.

7. The application according to claim 6, characterized in that, The pruritic skin disease is any one or more of eczema, pruritus, atopic dermatitis, seborrheic dermatitis, or contact dermatitis.

8. The application according to claim 6, characterized in that, The dosage form of the topical medicine is a topical granule, topical ointment, lotion, cream, gel, or liniment.

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