A blood-cooling and itching-relieving traditional Chinese medicine composition for inhibiting th2-type inflammatory factors and repairing skin barrier and application thereof

Abstract

This invention belongs to the field of traditional Chinese medicine technology and discloses a blood-cooling and antipruritic traditional Chinese medicine composition that inhibits Th2-type inflammatory factors and repairs the skin barrier, as well as its application. This traditional Chinese medicine composition can significantly inhibit the overexpression of Th2-type inflammatory factors (IL-4, IL-5, IL-13), alleviating skin inflammation, and can also promote the proliferation of keratinocytes and improve skin barrier function. It solves the problems of poor efficacy and easy recurrence associated with single anti-inflammatory or barrier-repair methods in existing technologies. Furthermore, the raw materials are all natural traditional Chinese medicines, ensuring high safety and no obvious toxic side effects. It can be widely used in the preparation of drugs, skin care products, and topical preparations for treating atopic dermatitis and other inflammatory skin diseases, demonstrating good clinical application value and promising industrial transformation prospects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a blood-cooling and itch-relieving traditional Chinese medicine composition that inhibits Th2-type inflammatory factors and repairs the skin barrier, and its application, particularly the application of this traditional Chinese medicine composition in the treatment of inflammatory skin diseases such as atopic dermatitis. Background Technology

[0002] Atopic dermatitis (AD) is a common chronic inflammatory skin disease characterized by hyperactive Th2-cell-driven type 2 inflammatory response and impaired skin barrier function. These two factors interact to create a vicious cycle of "inflammation exacerbating barrier damage, and barrier damage further inducing inflammation," leading to skin erythema, intense itching, and eczema-like changes, severely impacting patients' quality of life. Overexpression of Th2 inflammatory factors (such as IL-4, IL-5, and IL-13) is key to triggering skin inflammation and itching, while impaired skin barrier function leads to stratum corneum hyperplasia and abnormal terminal differentiation, making the skin prone to dehydration and susceptibility to external stimuli, further exacerbating inflammation and causing recurrence.

[0003] Currently, the main drugs used in clinical treatment of this type of inflammatory skin disease include topical corticosteroids, JAK inhibitors, and biologics (such as dupilumab). Although they can relieve inflammatory symptoms in the short term, long-term use can easily cause adverse reactions such as skin atrophy and telangiectasia, and the relapse rate is high after discontinuation. Oral antihistamines and immunosuppressants may damage the digestive system and liver and kidney function, while biologics are expensive, which limits their widespread use.

[0004] Traditional Chinese medicine (TCM) possesses unique advantages in the treatment of inflammatory skin diseases. Based on holistic diagnosis and treatment, it exerts its effects through multiple targets and pathways, exhibiting high safety and minimal side effects. TCM considers these skin diseases to fall under the category of "blood heat and wind excess, internal dampness and toxin accumulation, and malnourishment of the skin," with treatment principles primarily focused on cooling the blood and relieving itching, clearing heat and moisturizing dryness, and repairing the skin barrier. While some TCM compositions exist for cooling the blood and relieving itching, most only focus on single anti-inflammatory or antipruritic effects, failing to simultaneously achieve the synergistic effect of inhibiting Th2-type inflammatory factors and repairing the skin barrier. This makes it difficult to fundamentally break the vicious cycle of inflammation and barrier damage, resulting in limited treatment efficacy and a high recurrence rate. Furthermore, some compositions are poorly formulated, with unclear pharmacodynamic material bases, making quality control difficult and affecting the stability of therapeutic efficacy.

[0005] Furthermore, existing traditional Chinese medicine (TCM) compositions often lack a clear understanding of their inhibitory effects on Th2-type inflammatory factors and the specific mechanisms of skin barrier repair, and lack corresponding experimental data to support their claims, making it difficult to meet the requirement of full disclosure in the patent application. Therefore, developing a scientifically formulated TCM composition with significant synergistic effects that can effectively inhibit Th2-type inflammatory factors, relieve itching and inflammation, repair the skin barrier, reduce recurrence rates, and meet patent application requirements—a blood-cooling and antipruritic TCM composition—has significant clinical and industrial value. Summary of the Invention

[0006] To address the shortcomings of existing technologies, the present invention aims to provide a traditional Chinese medicine composition that inhibits Th2-type inflammatory factors and repairs the skin barrier, thereby relieving itching and promoting blood circulation. This solves the problems of poor synergistic effects of existing traditional Chinese medicine compositions in anti-inflammation and barrier repair, easy recurrence, and unreasonable formulation. Simultaneously, the invention provides a method for preparing this traditional Chinese medicine composition and its application, clarifies its pharmacological mechanism of action, meets the requirement of full disclosure in the patent examination guidelines, and provides a safe, effective, and stable traditional Chinese medicine solution for the treatment of inflammatory skin diseases.

[0007] To address the aforementioned technical problems, this invention provides a traditional Chinese medicine composition that cools the blood and relieves itching by inhibiting Th2-type inflammatory factors and repairing the skin barrier.

[0008] The traditional Chinese medicine composition of this invention is composed of the following raw materials in parts by weight: principal ingredient: purslane 15-30 parts, rehmannia root 10-20 parts; assistant ingredient: indigo leaf 10-20 parts, schizonepeta spike 8-15 parts, hemp seed 8-15 parts; adjuvant ingredient: sophora flavescens 6-12 parts, kochia scoparia fruit 6-12 parts, phellodendron bark 6-12 parts, gallnut 3-8 parts.

[0009] Furthermore, the preferred weight ratio of the traditional Chinese medicine composition of the present invention is as follows: purslane 20-25 parts, rehmannia root 12-18 parts, indigo leaf 12-18 parts, schizonepeta spike 10-12 parts, hemp seed 10-12 parts, sophora root 8-10 parts, kochia fruit 8-10 parts, phellodendron bark 8-10 parts, and gallnut 5-6 parts.

[0010] Furthermore, the optimal weight ratio of the traditional Chinese medicine composition of the present invention is as follows: 22 parts of purslane, 15 parts of rehmannia root, 15 parts of indigo leaf, 11 parts of schizonepeta spike, 11 parts of hemp seed, 9 parts of sophora root, 9 parts of kochia fruit, 9 parts of phellodendron bark, and 5.5 parts of gallnut.

[0011] This invention's formulation follows the traditional Chinese medicine principle of "principal, assistant, and adjuvant" drug pairing. The principal herbs, purslane and rehmannia root, work together to cool the blood, relieve itching, nourish yin, and generate fluids, targeting the core pathogenesis of "blood heat and wind excess, leading to malnourishment of the skin." The assistant herbs, indigo leaf, schizonepeta spike, and hemp seed, assist the principal herbs, enhancing their heat-clearing, blood-cooling, wind-dispelling, and itching-relieving effects, while also addressing skin barrier repair and harmonizing the medicinal properties. The adjuvant herbs, sophora flavescens, kochia scoparia, phellodendron bark, and gallnut, support the principal and assistant herbs, enhancing their anti-inflammatory, antipruritic, and astringent effects, synergistically repairing the skin barrier. The entire formula is scientifically formulated, with a balanced balance of cold and warm properties, avoiding damage to the skin from single cold-natured herbs while achieving a synergistic effect of "anti-inflammatory, antipruritic, and barrier repair," fundamentally breaking the vicious cycle of inflammation and barrier damage.

[0012] Meanwhile, this application provides a method for preparing a traditional Chinese medicine composition, comprising the following steps: (1) Raw material pretreatment: each Chinese medicinal material is crushed and passed through an 80-100 mesh sieve to remove impurities and set aside. The crushing particle size is controlled at 80-100 mesh, which can increase the contact area between the raw material and the extraction solvent, improve the extraction rate of effective components, and facilitate the subsequent preparation.

[0013] (2) Extraction: Take the pretreated raw materials, add 8-12 times the amount of deionized water, soak for 30-60 minutes to fully wet the raw materials and facilitate the dissolution of effective components; heat to boiling, simmer for 2-3 times, each time for 30-60 minutes, combine the decoctions, filter, and obtain the filtrate; the water decoction method conforms to the traditional Chinese medicine extraction process, is simple to operate, low in cost, and can retain the water-soluble effective components of each raw material to the maximum extent, avoiding organic solvent residue.

[0014] (3) Concentration and drying: The filtrate is concentrated under reduced pressure to a clear extract with a relative density of 1.10-1.20 (60℃), and then spray-dried or freeze-dried under vacuum. After pulverizing, it is passed through a 100-mesh sieve to obtain the dry powder of the Chinese medicine composition. Concentration under reduced pressure can remove moisture at a lower temperature and avoid damage to the active ingredients. Freeze-drying under vacuum can better preserve the activity of the active ingredients and improve the stability of the composition. Spray drying is suitable for large-scale industrial production.

[0015] (4) Formulation: As needed, the dry powder of the Chinese medicine composition is mixed with pharmaceutically acceptable excipients to form external or oral preparations. External preparations can be ointments, creams, lotions, wet compresses, gels, sprays, etc., while oral preparations can be capsules, tablets, granules, etc. Excipients can be selected according to dosage form requirements. For example, ointments can be made with petrolatum, lanolin, etc. as a base, and lotions can be made with ethanol, propylene glycol, etc. as a cosolvent. These are all commonly used excipients in the pharmaceutical field and have high safety.

[0016] Preferably, in step (2), the decoction is performed twice. The first time, 10 times the amount of deionized water is added, the mixture is soaked for 45 minutes, and then decocted for 45 minutes. The second time, 8 times the amount of deionized water is added, and the mixture is decocted for 35 minutes. This parameter can reduce the extraction time and solvent usage while ensuring that the effective ingredients are fully extracted, thereby reducing production costs.

[0017] Preferably, in step (3), vacuum freeze drying is used, with a drying temperature of -40℃ to -30℃ and a vacuum degree of 10-20Pa. This condition can maximize the preservation of the activity of the active ingredients, avoid the influence of high temperature on the efficacy, and the resulting dry powder has good solubility and high stability.

[0018] In addition, this application provides an application of a traditional Chinese medicine composition, as follows: The traditional Chinese medicine composition of this invention has significant effects in inhibiting Th2-type inflammatory factors, cooling blood and relieving itching, and repairing the skin barrier. It can be widely used in the preparation of drugs that inhibit Th2-type inflammatory factors, drugs or skin care products that repair the skin barrier, and drugs for treating Th2-type inflammatory skin diseases.

[0019] Among them, the Th2-type inflammation-mediated inflammatory skin diseases include one or more of atopic dermatitis, eczema, and contact dermatitis, and are especially suitable for the treatment of atopic dermatitis. They can effectively relieve symptoms such as skin erythema, itching, dryness, and desquamation, and reduce the recurrence rate.

[0020] The dosage form of the drug or skin care product is preferably a topical preparation, including one of ointment, cream, lotion, wet compress, gel, or spray. Topical preparations can act directly on the lesion site, have a rapid onset of action, and can reduce the irritation of oral preparations to the gastrointestinal tract, thus improving the safety of medication. In the topical preparation, the mass fraction of the dry powder of the traditional Chinese medicine composition is 5%-20%. This concentration range can ensure efficacy while avoiding skin irritation caused by high concentrations. Experimental verification shows that the composition has the best anti-inflammatory and barrier repair effects within this concentration range, and also has good safety.

[0021] By adopting the above technical solution, the traditional Chinese medicine composition of the present invention reduces skin inflammation and infiltration, and relieves symptoms such as erythema and itching by inhibiting the overexpression of Th2-type inflammatory factors (IL-4, IL-5, IL-13). At the same time, it promotes the proliferation of keratinocytes, improves abnormal terminal differentiation of the stratum corneum, increases skin moisture content, repairs skin barrier function, and reduces the invasion of external irritants and allergens, thereby breaking the vicious cycle of inflammation and barrier damage, achieving both symptomatic and radical treatment. Moreover, the raw materials are all natural traditional Chinese medicines, and there are no obvious toxic side effects with long-term use, solving the problems of large adverse reactions and easy recurrence of existing drugs. Attached Figure Description

[0022] Figure 1This is a bar chart showing the effect of the traditional Chinese medicine composition of the present invention on the serum IL-4 content in mice with atopic dermatitis; Figure 2 This is a bar chart showing the effect of the traditional Chinese medicine composition of the present invention on the serum IL-5 content in mice with atopic dermatitis; Figure 3 This is a bar chart showing the effect of the traditional Chinese medicine composition of the present invention on the serum IL-13 content in mice with atopic dermatitis; Figure 4 This is a bar chart showing the effect of the traditional Chinese medicine composition of the present invention on the skin water content of mice with atopic dermatitis. Detailed Implementation

[0023] The present invention will be further described in detail below with reference to specific embodiments. The following embodiments are only used to illustrate the present invention and are not intended to limit the scope of protection of the present invention.

[0024] Example 1 A traditional Chinese medicine composition for cooling the blood and relieving itching that inhibits Th2-type inflammatory factors and repairs the skin barrier, wherein the weight parts of each raw material are: 15 parts of purslane, 10 parts of rehmannia root, 10 parts of indigo leaf, 8 parts of schizonepeta spike, 8 parts of hemp seed, 6 parts of sophora root, 6 parts of kochia fruit, 6 parts of phellodendron bark, and 3 parts of gallnut.

[0025] Preparation method: (1) Raw material pretreatment: each Chinese medicinal material is crushed and passed through an 80-mesh sieve to remove impurities and set aside; (2) Extraction: take the pretreated raw material, add 8 times the amount of deionized water, soak for 30 minutes, heat to boiling, and simmer twice. The first simmering is for 30 minutes, and the second simmering is for 30 minutes with 8 times the amount of deionized water added. Combine the simmering liquids, filter, and obtain filtrate; (3) Concentration and drying: the filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.10 (60℃), spray-dried (inlet air temperature 180℃, outlet air temperature 80℃), crushed and passed through a 100-mesh sieve to obtain dry powder of Chinese medicinal composition; (4) Formulation: take 5 parts of dry powder of Chinese medicinal composition, add 95 parts of petrolatum, heat to melt, stir evenly, and cool to make ointment.

[0026] Example 2 A traditional Chinese medicine composition for cooling the blood and relieving itching that inhibits Th2-type inflammatory factors and repairs the skin barrier, wherein the weight parts of each raw material are: 30 parts of purslane, 20 parts of rehmannia root, 20 parts of indigo leaf, 15 parts of schizonepeta spike, 15 parts of hemp seed, 12 parts of sophora flavescens, 12 parts of kochia fruit, 12 parts of phellodendron bark, and 8 parts of gallnut.

[0027] Preparation method: (1) Raw material pretreatment: each Chinese medicinal material is crushed and passed through a 100-mesh sieve to remove impurities and set aside; (2) Extraction: take the pretreated raw material, add 12 times the amount of deionized water, soak for 60 minutes, heat to boiling, and simmer for 3 times. The first decoction is 60 minutes, and the second and third decoctions are each 10 times the amount of deionized water and simmered for 45 minutes. Combine the decoctions, filter, and obtain filtrate; (3) Concentration and drying: the filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.20 (60℃), and then freeze-dried under vacuum (temperature -40℃, vacuum degree 10Pa). After crushing, it is passed through a 100-mesh sieve to obtain the dry powder of the Chinese medicine composition; (4) Formulation: take 20 parts of the dry powder of the Chinese medicine composition, add 10 parts of propylene glycol, 10 parts of ethanol, and 60 parts of deionized water, stir to dissolve, and prepare a lotion.

[0028] Example 3 A traditional Chinese medicine composition for cooling the blood and relieving itching that inhibits Th2-type inflammatory factors and repairs the skin barrier, wherein the weight parts of each raw material are: purslane 20 parts, rehmannia root 12 parts, indigo leaf 12 parts, schizonepeta spike 10 parts, hemp seed 10 parts, sophora root 8 parts, kochia fruit 8 parts, phellodendron bark 8 parts, and gallnut 5 parts.

[0029] Preparation method: (1) Raw material pretreatment: each Chinese medicinal material is crushed and passed through a 90-mesh sieve to remove impurities and set aside; (2) Extraction: take the pretreated raw material, add 10 times the amount of deionized water, soak for 40 minutes, heat to boiling, and simmer twice. The first simmering is for 40 minutes, and the second simmering is for 35 minutes with 8 times the amount of deionized water added. Combine the simmering liquids, filter, and obtain filtrate; (3) Concentration and drying: the filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.15 (60℃), and then freeze-dried under vacuum (temperature -35℃, vacuum degree 15Pa). After crushing, it is passed through a 100-mesh sieve to obtain the dry powder of the Chinese medicine composition; (4) Formulation: take 10 parts of the dry powder of the Chinese medicine composition, add 1 part of carbomer, 0.5 parts of triethanolamine, 5 parts of glycerin, and 83.5 parts of deionized water, stir evenly, and make a gel.

[0030] Example 4 A traditional Chinese medicine composition for cooling the blood and relieving itching that inhibits Th2-type inflammatory factors and repairs the skin barrier, wherein the weight parts of each raw material are: purslane 25 parts, rehmannia root 18 parts, indigo leaf 18 parts, schizonepeta spike 12 parts, hemp seed 12 parts, sophora flavescens 10 parts, kochia fruit 10 parts, phellodendron bark 10 parts, and gallnut 6 parts.

[0031] Preparation method: Same as in Example 3, except that in step (4), 15 parts of the dry powder of the Chinese medicine composition are taken, 5 parts of lanolin and 80 parts of petrolatum are added, heated and melted, stirred evenly, and cooled to make an ointment.

[0032] Example 5 A traditional Chinese medicine composition for cooling the blood and relieving itching that inhibits Th2-type inflammatory factors and repairs the skin barrier, wherein the weight parts of each raw material are: purslane 22 parts, rehmannia root 15 parts, indigo leaf 15 parts, schizonepeta spike 11 parts, hemp seed 11 parts, sophora root 9 parts, kochia fruit 9 parts, phellodendron bark 9 parts, and gallnut 5.5 parts.

[0033] Preparation method: (1) Raw material pretreatment: each Chinese medicinal material is crushed and passed through a 100-mesh sieve to remove impurities and set aside; (2) Extraction: take the pretreated raw material, add 10 times the amount of deionized water, soak for 45 minutes, heat to boiling, and simmer twice. The first simmering is for 45 minutes, and the second simmering is for 35 minutes with 8 times the amount of deionized water added. Combine the simmering liquids, filter, and obtain filtrate; (3) Concentration and drying: the filtrate is concentrated under reduced pressure to a clear paste with a relative density of 1.15 (60℃), and then freeze-dried under vacuum (temperature -35℃, vacuum degree 15Pa). After crushing, it is passed through a 100-mesh sieve to obtain the dry powder of the Chinese medicine composition; (4) Formulation: take 12 parts of the dry powder of the Chinese medicine composition, add 15 parts of ethanol, 8 parts of glycerin, and 65 parts of deionized water, stir to dissolve, add an appropriate amount of fragrance, and make a spray.

[0034] Example 6 The efficacy of the traditional Chinese medicine composition of the present invention was experimentally verified.

[0035] 1. Experimental objective: To verify the inhibitory effect of the traditional Chinese medicine composition of the present invention on Th2-type inflammatory factors and its skin barrier repair effect.

[0036] 2. Experimental materials: The dry powder of the traditional Chinese medicine composition prepared in Example 5 (optimal ratio) was selected. Control group 1 was glucocorticoid ointment (dexamethasone ointment), control group 2 was commercially available blood-cooling and antipruritic traditional Chinese medicine ointment, model group was physiological saline, experimental animals were SPF grade BALB / c mice (weight 20±2g), Th2 type inflammatory factor (IL-4, IL-5, IL-13) detection kit, and skin moisture meter.

[0037] 3. Experimental Methods: (1) Construction of atopic dermatitis mouse model: 2,4-dinitrochlorobenzene (DNCB) was used to induce skin inflammation on the back of mice to establish an atopic dermatitis model. After successful modeling, the mice were randomly divided into 4 groups of 10 mice each, namely model group, control group 1, control group 2, and experimental group (the composition group of this invention).

[0038] (2) Administration method: The experimental group mice were given the cream of the Chinese medicine composition of the present invention (containing 12% dry powder of the composition) on their backs, the control group 1 was given dexamethasone ointment, the control group 2 was given commercially available blood-cooling and antipruritic Chinese medicine ointment, and the model group was given physiological saline. The cream was given twice a day, 0.2g each time, for 14 consecutive days.

[0039] (3) Index detection: 14 days after administration, mouse serum was collected and the contents of IL-4, IL-5 and IL-13 in the serum were detected by ELISA; the skin moisture content of the back skin of mice was detected by skin moisture meter to evaluate the skin barrier function; the improvement of symptoms such as skin erythema, itching and desquamation of mice was observed and recorded.

[0040] 4. Experimental Results: (1) Inflammatory factor levels: The serum levels of IL-4, IL-5, and IL-13 in the model group mice were (186.32±15.78) pg / mL, (98.45±8.92) pg / mL, and (156.79±12.35) pg / mL, respectively, which were significantly higher than those in the other three groups (P<0.01); the serum levels of IL-4, IL-5, and IL-13 in the experimental group mice were (68.54±7.21) pg / mL, (32.16±4.35) pg / mL, and (59.87±6.89) pg / mL, respectively, which were significantly lower than those in the control group (IL-4: 102.67±9.53 pg / mL, IL-5: 56.89±6.12 pg / mL, IL-13: 98.45±8.76 pg / mL). The difference in pg / mL between the two groups was statistically significant (P<0.05); there was no significant difference between the two groups and control group 1 (IL-4: 65.32±6.87 pg / mL, IL-5: 30.89±4.12 pg / mL, IL-13: 57.63±6.54 pg / mL) (P>0.05), indicating that the composition of the present invention has a significant inhibitory effect on Th2 inflammatory factors, with an effect close to that of glucocorticoids and superior to commercially available similar traditional Chinese medicine ointments. Experimental data were analyzed by one-way ANOVA using SPSS 26.0 software, and multiple comparisons between groups were performed using the LSD method, with a statistical significance level of α=0.05.

[0041] (2) Skin moisture content: The skin moisture content of the model group mice was (28.65±3.21)%, significantly lower than that of the other three groups (P<0.01); the skin moisture content of the experimental group mice was (58.79±4.56)%, significantly higher than that of control group 1 (45.32±3.89)% and control group 2 (40.15±3.67)%, with statistically significant differences (P<0.05); there was no significant difference between control group 1 and control group 2 (P>0.05), indicating that the composition of the present invention has a significant skin barrier repair effect, which is superior to glucocorticoids and commercially available similar traditional Chinese medicine ointments. The skin moisture content was detected by a three-point sampling method, with three different sites selected on the back of each mouse for measurement, and the average value was taken as the final data. The experimental data were statistically analyzed by SPSS 26.0 software, and the t-test was used for inter-group comparisons, with a statistical significance level of α=0.05.

[0042] (3) Symptom improvement: The skin symptom scoring scale (0-10 points, 0 points for no symptoms, 10 points for the most severe symptoms) was used to score the symptoms of erythema, itching and desquamation in mice. Before administration, there was no significant difference in the symptom scores of mice in each group (P>0.05), and all were above 8.5 points. After 14 days of administration, the skin symptom score of mice in the experimental group was (0.8±0.3) points, and the symptoms such as erythema, itching and desquamation basically disappeared, with an improvement rate of 90% (9 / 10 mice were completely relieved of symptoms). The symptom score of control group 1 was (1.2±0.4) points, with an improvement rate of 85% (symptom relief in 8 / 10 mice), but 3 mice experienced adverse reactions such as thinning of the skin and slight telangiectasia. The symptom score of control group 2 was (3.2±0.6) points, with an improvement rate of 65% (symptom relief in 6 / 10 mice), but significant erythema and mild itching remained. The symptom score of the model group was (9.1±0.5) points, with no improvement in symptoms, and even worsening manifestations such as skin ulceration and exudation. Symptom scores were assessed by two independent dermatologists in a blinded manner, and the average score was taken as the final score. Differences between groups were analyzed using a non-parametric test (Kruskal-Wallis H test), with P<0.05 considered statistically significant.

[0043] 5. Experimental Conclusion: The traditional Chinese medicine composition of this invention can significantly inhibit the expression of Th2-type inflammatory factors (IL-4, IL-5, IL-13), effectively repair the skin barrier function, and alleviate the skin symptoms of atopic dermatitis mice, with no obvious adverse reactions. The effect is better than commercially available similar traditional Chinese medicine products, and the safety is higher than that of glucocorticoids, which has good clinical application value.

[0044] In each bar chart, the horizontal axis represents the experimental group (model group, control group 1, control group 2, experimental group), and the vertical axis represents the IL-4, IL-5, and IL-13 content (pg / mL) and skin moisture content (%), respectively. The error bars represent the standard deviation (n=10). * indicates P<0.05 compared with the model group, ** indicates P<0.01 compared with the model group, # indicates P<0.05 compared with control group 2, and ## indicates P<0.01 compared with control group 2.

[0045] The above embodiments are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Any modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

[0046] It should be noted that the proportion of raw materials in the traditional Chinese medicine composition of the present invention can be adjusted within the range defined in the claims. The extraction parameters, drying methods, dosage forms, etc. in the preparation method can also be adapted according to actual needs. As long as the technical effects of the present invention can be achieved, they all fall within the protection scope of the present invention.

[0047] Furthermore, the application of the traditional Chinese medicine composition of the present invention is not limited to atopic dermatitis, eczema, and contact dermatitis mentioned in the above embodiments, but can also be applied to other inflammatory skin diseases mediated by Th2-type inflammation and accompanied by skin barrier damage, all of which fall within the protection scope of the present invention.

[0048] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for cooling the blood and relieving itching that inhibits Th2-type inflammatory factors and repairs the skin barrier, characterized in that, It is composed of the following raw materials in parts by weight: Principal ingredient: 15-30 parts of purslane and 10-20 parts of rehmannia root; Assistant ingredient: 10-20 parts of indigo leaf, 8-15 parts of schizonepeta spike and 8-15 parts of hemp seed; Adjuvant ingredient: 6-12 parts of sophora flavescens, 6-12 parts of kochia scoparia fruit, 6-12 parts of phellodendron bark and 3-8 parts of gallnut.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The weight ratio of each raw material is as follows: purslane 20-25 parts, rehmannia root 12-18 parts, indigo leaf 12-18 parts, schizonepeta spike 10-12 parts, hemp seed 10-12 parts, sophora flavescens 8-10 parts, kochia fruit 8-10 parts, phellodendron bark 8-10 parts, gallnut 5-6 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The weight ratio of each raw material is as follows: purslane 22 parts, rehmannia root 15 parts, indigo leaf 15 parts, schizonepeta spike 11 parts, hemp seed 11 parts, sophora root 9 parts, kochia fruit 9 parts, phellodendron bark 9 parts, gallnut 5.5 parts.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, Hemp seeds are selected from dried, mature seeds that have been processed, while raw rehmannia root is selected from dried tuberous roots.

5. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, Includes the following steps: (1) Raw material pretreatment: Each Chinese medicinal material is crushed separately, passed through an 80-100 mesh sieve to remove impurities, and set aside; (2) Extraction: Take the pretreated raw material, add 8-12 times the amount of deionized water, soak for 30-60 minutes, heat to boiling, and simmer for 2-3 times, each time for 30-60 minutes, combine the decoctions, filter, and obtain filtrate; (3) Concentration and drying: Concentrate the filtrate under reduced pressure to a clear paste with a relative density of 1.10-1.20 (60℃), spray dry or vacuum freeze dry, crush and pass through a 100 mesh sieve to obtain dry powder of Chinese medicinal composition; (4) Formulation: As needed, mix the dry powder of Chinese medicinal composition with pharmaceutically acceptable excipients to make external or oral preparations.

6. The preparation method according to claim 5, characterized in that, In step (2), the decoction is performed twice. The first time, 10 times the amount of deionized water is added, soaked for 45 minutes, and decocted for 45 minutes. The second time, 8 times the amount of deionized water is added and decocted for 35 minutes. In step (3), vacuum freeze drying is used. The drying temperature is -40℃ to -30℃ and the vacuum degree is 10-20Pa.

7. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a drug that inhibits Th2-type inflammatory factors.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a medicine or skin care product for repairing the skin barrier.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-4 in the preparation of a medicament for treating Th2-type inflammation-mediated inflammatory skin diseases, characterized in that, The inflammatory skin disease mentioned is one or more of atopic dermatitis, eczema, and contact dermatitis.

10. The application according to any one of claims 7-9, characterized in that, The dosage form of the drug or skin care product is a topical preparation, including one of ointment, cream, lotion, wet compress, gel, and spray; in the topical preparation, the mass fraction of the dry powder of the traditional Chinese medicine composition is 5%-20%.

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