A traditional Chinese medicine composition, a preparation method therefor and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition, its preparation method, and its application, belonging to the field of traditional Chinese medicine compositions. Based on modern pharmacological research, this invention constructs a multi-target synergistic system, using Polygonum cuspidatum, Coptis chinensis, and Sophora flavescens as the core principal herbs, supplemented by Portulaca oleracea, and with Stemona japonica and Zanthoxylum bungeanum as adjuvant herbs, along with menthol and borneol. The entire formula works synergistically to clear heat and reduce inflammation, dispel wind and relieve itching, repair the skin barrier, and regulate immunity, forming a multi-target closed-loop system of "clearing heat and reducing inflammation—dispelling wind and relieving itching—repairing the skin barrier—regulating immunity," with stable efficacy. Animal model verification shows that this invention can significantly improve skin lesion symptoms and downregulate inflammatory factor levels. Simultaneously, the traditional Chinese medicine composition of this invention aligns with the pathogenesis of "damp-heat accumulation" and "heat-toxin accumulation," taking into account both vaginal microecological repair and pathogenic bacteria inhibition, effectively treating simple vaginitis. The preparation process of this invention is standardized, the content of effective components is stable, and it can be formulated into various dosage forms, providing a safe and effective therapeutic drug for clinical use.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine compositions, and in particular to a traditional Chinese medicine composition, its preparation method, and its application. Background Technology

[0002] Simple vaginitis is a common vulvovaginal inflammatory disease in gynecological clinics. It mainly refers to inflammation of the vaginal mucosa and submucosal tissue caused by a single pathogen infection, local physical or chemical irritation, or mild abnormalities in immune function, without complex complications. It is most common in women of reproductive age, and some postmenopausal women may also develop the disease due to hormonal changes. Currently, clinical treatment for simple vaginitis mainly focuses on symptomatic medication. Bacterial vaginosis and trichomonal vaginitis are often treated with oral or topical antibiotics such as metronidazole and clindamycin. Vulvovaginal candidiasis is treated with antifungal drugs such as clotrimazole and miconazole. Atrophic simple vaginitis requires local estrogen supplementation to improve the vaginal environment. However, existing treatment options have significant limitations: on the one hand, long-term or repeated use of antibiotics and antifungal drugs can easily induce the development of drug-resistant strains in the vagina, reducing treatment effectiveness and further disrupting the vaginal microecological balance dominated by lactobacilli, forming a vicious cycle of "treatment-relapse-retreatment"; on the other hand, while topical medications (such as suppositories and ointments) can act directly on the lesions, some patients experience inconvenience in use (such as needing to discontinue use during menstruation) and local irritation (such as burning and stinging), resulting in poor compliance; furthermore, for non-infectious simple vaginitis (such as allergies or irritation-induced vaginitis), there is currently a lack of targeted treatments to regulate the vaginal mucosal barrier function, with most treatments focusing on symptomatic relief of itching and avoiding triggers, leading to long treatment cycles and a high recurrence rate. The core of these problems lies in the fact that existing treatment options primarily focus on eliminating pathogens, failing to adequately address the repair of the vaginal microecology and the restoration of mucosal barrier function, while lacking comprehensive treatment methods that balance efficacy and ease of use.

[0003] In the theoretical system of traditional Chinese medicine, simple vaginitis falls under the categories of "leukorrhea" and "vaginal itching". Traditional Chinese medicine treatment often follows the principle of "differentiation of syndromes and treatment", with the core treatment methods being clearing heat and dampness, detoxifying and relieving itching, strengthening the spleen and kidneys, and regulating the Chong and Ren meridians. Symptoms are improved through oral and external Chinese medicine (such as fumigation, sitz baths, and suppositories). It has unique advantages in restoring the vaginal microecology and reducing the recurrence rate. However, existing traditional Chinese medicine (TCM) compositions and their preparation techniques for treating uncomplicated vaginitis have significant shortcomings: First, the formulations often follow traditional prescriptions, lacking systematic optimization based on modern pharmacological research. They fail to fully consider the synergistic effects between raw materials, and standardized medication regimens for different syndrome types (such as damp-heat accumulation, spleen deficiency with dampness, and kidney yin deficiency) have not yet been fully established, hindering the standardization of clinical application. Second, the preparation processes often employ simple decoction methods or direct application of coarse powder, resulting in low extraction rates of effective components, high impurity content, and limited dosage forms (mainly decoctions or washes). This leads to poor stability of active ingredients, inconvenience in use, and low patient compliance. Third, most TCM compositions lack rigorous pharmacodynamic and safety verification, resulting in a lack of objective data to support efficacy, unclear potential side effects, and difficulty meeting modern clinical requirements for drug safety, efficacy, and quality control. These problems restrict the stability of existing TCM treatment regimens in terms of efficacy, ease of use, and clinical application value.

[0004] Eczema is an inflammatory skin reaction caused by the combined effects of internal and external factors. Clinically, it manifests as erythema, papules, vesicles, exudation, crusting, and intense itching, characterized by recurrent episodes. Currently, Western medicines used to treat eczema mainly include topical corticosteroids, oral antihistamines, and immunosuppressants. However, these drugs all have limitations in terms of safety, tolerability, and duration of efficacy in clinical application. Existing traditional Chinese medicine (TCM) compositions for treating eczema are mostly based on the traditional principles of clearing heat and dampness, dispelling wind, and relieving itching. Commonly used ingredients include Sophora flavescens, Phellodendron chinense, Kochia scoparia, and Cnidium monnieri. However, these technologies also suffer from problems such as a lack of multi-target synergistic mechanisms in formulation design, outdated preparation processes, insufficient quality control, and insufficient attention to skin barrier repair and immune regulation, leading to a high recurrence rate after treatment. In summary, whether for treating simple vaginitis or eczema, existing TCM compositions generally suffer from problems such as a lack of systematic optimization of formulation design based on modern pharmacological research, ineffective integration of preparation processes with modern extraction and separation techniques, limited dosage forms, low standardization of quality, and insufficient stability of clinical efficacy. Solving the aforementioned problems requires the integration of multiple disciplines, including traditional Chinese medicine, modern pharmacology, pharmaceutical preparations, and quality control, making research and development quite challenging. Therefore, there is an urgent need in this field to develop a scientifically designed, technologically advanced, effective, and safe traditional Chinese medicine composition that can simultaneously achieve synergistic effects on multiple targets, such as pathogen clearance or inflammation suppression, microecological balance restoration or skin barrier repair, and immune regulation. Furthermore, it should be convenient to use and have high compliance rates, thus addressing common technical problems in existing technologies in clinical applications, such as unstable efficacy, high recurrence rates, and inconvenience of use. Summary of the Invention

[0005] The purpose of this invention is to provide a traditional Chinese medicine composition, its preparation method, and its application, to address the problems existing in the prior art. Based on modern pharmacological research, this invention constructs a multi-target synergistic system, solving the problems of lack of optimized formulation and unstable efficacy. Animal model validation shows that this invention can significantly improve skin lesion symptoms and downregulate inflammatory factor levels. Furthermore, the preparation process of this invention is standardized, the content of active ingredients is stable, it can be formulated into various dosage forms, and it is convenient to use, providing a safe and effective treatment for acute eczema in clinical practice.

[0006] To achieve the above objectives, the present invention provides the following solution: This invention provides a traditional Chinese medicine composition comprising the following components in parts by weight: 80-120 parts of Polygonum cuspidatum, 80-120 parts of Coptis chinensis, 80-120 parts of Sophora flavescens, 30-70 parts of Portulaca oleracea, 20-40 parts of Stemona japonica, 10-20 parts of Zanthoxylum bungeanum, 3-7 parts of borneol and 3-7 parts of menthol.

[0007] Optionally, the traditional Chinese medicine composition comprises the following components in parts by weight: 120 parts Polygonum cuspidatum, 120 parts Coptis chinensis, 80 parts Sophora flavescens, 30 parts Portulaca oleracea, 20 parts Stemona japonica, 10 parts Zanthoxylum bungeanum, 3 parts Borneol, and 3 parts Menthol; or, The traditional Chinese medicine composition comprises the following components in parts by weight: 80 parts of Polygonum cuspidatum, 80 parts of Coptis chinensis, 120 parts of Sophora flavescens, 70 parts of Portulaca oleracea, 40 parts of Stemona japonica, 20 parts of Zanthoxylum bungeanum, 7 parts of borneol and 7 parts of menthol.

[0008] The present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating acute eczema or simple vaginitis.

[0009] The herbal composition of the present invention has therapeutic effects on both acute eczema and simple vaginitis within the specified weight range.

[0010] Among them, when the mass fractions of Polygonum cuspidatum and Coptis chinensis in the traditional Chinese medicine composition are low, the therapeutic effect on acute eczema is better; When the content of Polygonum cuspidatum and Coptis chinensis in the above-mentioned traditional Chinese medicine composition is high, the therapeutic effect on simple vaginitis is better.

[0011] The present invention also provides a medicament for treating acute eczema or simple vaginitis, wherein the raw materials for preparing the medicament include the aforementioned traditional Chinese medicine composition.

[0012] Optionally, the drug may also include pharmaceutically acceptable excipients.

[0013] Optionally, the dosage form of the drug includes topical liquid preparations, topical cream preparations, and topical suppositories.

[0014] The present invention also provides a method for preparing the aforementioned drug, comprising the following steps: (1) Dry the Polygonum cuspidatum, Coptis chinensis, Sophora flavescens, Portulaca oleracea, Stemona japonica and Zanthoxylum bungeanum, then grind them into powder and mix them to obtain a mixed coarse powder; grind the borneol and menthol into fine powder separately for later use; (2) Add pure water to the mixed coarse powder for extraction, collect the extract, concentrate it to obtain the original Chinese medicine liquid, and cool it for later use; (3) Add borneol powder and menthol powder to the cooled Chinese herbal medicine liquid, mix well, and obtain the medicine; Alternatively, it may include the following steps: (S1) The Polygonum cuspidatum, Coptis chinensis, Sophora flavescens, Portulaca oleracea, Stemona japonica and Zanthoxylum bungeanum are sequentially soaked, decocted, decocted and concentrated to obtain an extract; (S2) The extract, menthol and borneol are mixed to obtain the drug.

[0015] Optionally, in step (2), the specific steps of extraction include: adding 9-10 times the weight of pure water to the mixed coarse powder, soaking for 0.5-1.5 hours, reflux extraction for 1.5-2.5 hours, and filtering; adding 7-9 times the weight of pure water to the filter residue, reflux extraction for 1.5-2.5 hours, and filtering; combining the two filtrates to obtain the extract; concentrating the extract under reduced pressure to 1 / 5-1 / 4 of the original volume to obtain the original Chinese medicine liquid.

[0016] Optionally, in step (S1), when performing the soaking treatment, the amount of water used is 3 to 5 times the total weight of the Polygonum cuspidatum, Coptis chinensis, Sophora flavescens, Portulaca oleracea, Stemona japonica, and Zanthoxylum bungeanum; the soaking conditions are: soaking at room temperature for 30 to 60 minutes. And / or, the conditions for the first decoction treatment are: boil for 30 to 45 minutes; And / or, when performing the second decoction treatment, the amount of water used is 3 to 5 times the weight of the dregs obtained from the first decoction treatment; the conditions for the second decoction treatment are: boil and then maintain for 20 to 30 minutes. And / or, the concentration process is a vacuum concentration process; the concentration process conditions are: 60~70℃, -0.08~-0.06MPa, concentrated to a relative density of 1.10~1.20.

[0017] Optionally, when the dosage form of the drug is a topical liquid preparation, the extract, menthol, and borneol are mixed, and then a preservative and a humectant are added to obtain the topical liquid preparation; when the dosage form of the drug is a topical suppository, the steps of drying and adding a matrix are further included before mixing the extract, menthol, and borneol. And / or, the matrix comprises semi-synthetic fatty acid glycerides.

[0018] The traditional Chinese medicine composition of this invention, in treating acute eczema, dermatitis, and other skin conditions caused by damp-heat accumulation, follows the traditional Chinese medicine theory of "principal, assistant, adjuvant, and guide" in its formulation. Its core treatment principles are "clearing heat and drying dampness, cooling blood and detoxifying, killing parasites and relieving itching, and anti-inflammatory and astringent," constructing a multi-target synergistic system. The entire formula consists of eight herbs: Sophora flavescens, Coptis chinensis, Polygonum cuspidatum, Portulaca oleracea, Stemona japonica, Zanthoxylum bungeanum, Borneol, and Menthol. Its formulation structure is as follows: The principal herbs are Sophora flavescens and Coptis chinensis. The combination of these two herbs directly counteracts damp-heat, resulting in a concentrated and potent effect.

[0019] Sophora flavescens: Bitter in taste and cold in nature. It excels at clearing heat and drying dampness, dispelling wind, killing parasites, and relieving itching. It is an essential medicine for treating itchy skin, eczema, dermatitis, and vulvar itching in women. Its main active ingredients, such as matrine and oxymatrine, have significant anti-inflammatory, anti-allergic, mast cell degranulation inhibition, and antipruritic effects. Coptis chinensis: bitter in taste and cold in nature. It excels at clearing heat and drying dampness, purging fire and detoxifying. Its core component, berberine, has a broad-spectrum inhibitory effect on a variety of pathogenic bacteria and fungi, and can strongly downregulate key pro-inflammatory factors such as IL-1β, IL-6, and TNF-α.

[0020] Both are principal herbs, targeting the core pathogenesis of damp-heat accumulation in the skin, playing a leading role in clearing heat and drying dampness, detoxifying and reducing inflammation, laying the foundation for the overall efficacy of the formula.

[0021] Assistant herbs: Polygonum cuspidatum and Portulaca oleracea. These assist the principal herbs, enhancing their effects of cooling the blood, detoxifying, reducing redness, and astringing.

[0022] Polygonum cuspidatum: Slightly bitter in taste and slightly cold in nature. Its functions include clearing heat and detoxifying, promoting diuresis and relieving jaundice, and dispersing blood stasis and relieving pain. Its active ingredients, such as polygaloside and resveratrol, not only have clear anti-inflammatory effects but also effectively improve local redness, swelling, and exudation, and cool the blood to remove blood stasis.

[0023] Purslane: Sour in taste and cold in nature. Its main functions are clearing heat and detoxifying, cooling the blood and stopping bleeding, and astringing and healing sores. Its acidic properties help to astringe moisture and promote wound healing, making it particularly suitable for skin lesions such as erythema, papules, and exudation.

[0024] Both are assistant herbs, which not only enhance the heat-clearing and dampness-drying power of the principal herb, but also focus on cooling the blood to reduce redness, detoxifying to reduce swelling, and astringing to reduce exudation, thus working together to improve symptoms such as skin redness, swelling, and erosion.

[0025] Adjuvant herbs: Stemona japonica and Sichuan pepper. These herbs assist the principal and assistant herbs, enhancing the effects of killing parasites, relieving itching, dispelling wind and drying dampness, and counteracting the overall cold nature of the formula.

[0026] Stemona japonica: Sweet and bitter in taste, slightly warm in nature. It excels at moistening the lungs, regulating qi, killing parasites, and relieving itching. When used externally, it can significantly relieve various types of stubborn itching. Its slightly warm nature can counteract the bitter and cold properties of the principal and assistant herbs, preventing damage to the yang qi of the skin.

[0027] Sichuan pepper: It has a pungent taste and warm properties. Its functions include warming the middle jiao (digestive system) to relieve pain, killing parasites and relieving itching, and drying dampness. Its pungent and dispersing properties dispel wind and relieve itching, while its warming and drying properties help to resolve dampness and turbidity. It also promotes local transdermal absorption.

[0028] Both are used as adjuvant medicines to work synergistically to relieve itching, which is the main symptom. They also have a warming effect to counteract the coldness of the whole formula, so that the formula is balanced in terms of heat and cold, and is gentle and long-lasting.

[0029] Medicinal ingredients: Borneol and menthol. These harmonize the other ingredients, guide their effects through the skin, and also provide a cooling and antipruritic effect.

[0030] Borneol: It has a pungent and bitter taste, and is slightly cold in nature. Its functions include opening the orifices and refreshing the mind, clearing heat and relieving pain. Its pungent and penetrating properties can guide other medicines directly to the site of the disease and enhance transdermal absorption.

[0031] Menthol: It has a pungent taste and cooling properties. Its functions include dispersing wind-heat, clearing the head and eyes, and relieving itching. When applied externally, it quickly produces a cooling sensation, blocks the transmission of itching signals, and provides immediate relief from discomfort.

[0032] Both act as delivery agents, working together to exert a comprehensive effect of "guiding the medicine into the skin, promoting transdermal penetration, and providing cooling and itch relief," thereby improving medication comfort and patient compliance.

[0033] The formula uses Sophora flavescens and Coptis chinensis as the chief herbs to directly clear damp-heat and toxins; Polygonum cuspidatum and Portulaca oleracea as assistant herbs to help the chief herbs cool the blood, detoxify, reduce redness, and heal sores; Stemona japonica and Zanthoxylum bungeanum are used as adjuvant herbs to specifically target insects, relieve itching, and counteract coldness; Borneol and Menthol are used as guiding herbs to penetrate the skin and relieve itching. These eight herbs work synergistically to clear heat and dry dampness, cool the blood and detoxify, kill insects and relieve itching, and have anti-inflammatory and astringent effects, demonstrating a definite therapeutic effect on damp-heat type skin problems such as eczema and dermatitis.

[0034] The traditional Chinese medicine composition of this invention, when used to treat simple vaginitis, also follows the above-mentioned treatment principles of "clearing heat and drying dampness, cooling blood and detoxifying, killing parasites and relieving itching, and anti-inflammatory and astringent." The formulation principle is as follows: The principal herbs (Sophora flavescens and Coptis chinensis) target the pathogenesis of vaginitis caused by "damp-heat accumulation in the lower burner." Sophora flavescens clears heat, dries dampness, kills parasites, and relieves itching, specifically treating vaginal itching and leukorrhea; Coptis chinensis purges fire, detoxifies, and has broad-spectrum antibacterial properties. Together, they directly clear damp-heat in the lower burner and strongly inhibit pathogenic microorganisms such as Candida albicans and Gardnerella vaginalis.

[0035] Assistant herbs (Polygonum cuspidatum and Portulaca oleracea): assist the principal herbs. Polygonum cuspidatum cools the blood, detoxifies, disperses blood stasis, and reduces swelling, thus improving mucosal congestion and edema. Portulaca oleracea cools the blood and astringes, reduces abnormal secretions, and promotes the repair of damaged mucosa.

[0036] Adjuvant herbs (Stemona japonica and Zanthoxylum bungeanum): Stemona japonica kills parasites and relieves itching, while Zanthoxylum bungeanum dries dampness, kills parasites, dispels wind, relieves itching, and is warm in nature. It can assist the principal herb in being bitter and cold, so as to balance the cold and warm properties of the prescription and enhance the antipruritic effect.

[0037] Medication guides (borneol, menthol): directs the medicinal effects directly to the affected area, increases local cooling and comfort, reduces irritation, and improves medication adherence.

[0038] The formula combines warming and cooling properties, addressing both the symptoms and the root cause. While inhibiting pathogens, it also repairs the vaginal microecology and mucosal barrier, reducing the recurrence rate.

[0039] The present invention discloses the following technical effects: Compared with existing technologies, this invention, guided by modern pharmacological research, uses Polygonum cuspidatum, Coptis chinensis, and Sophora flavescens as principal herbs. Through the synergistic action of multiple components such as polydipsia glycoside, emodin, berberine, and matrine on inflammatory signaling pathways like NF-κB and MAPK, it forms a multi-target closed-loop system of "clearing heat and reducing inflammation—dispelling wind and relieving itching—repairing the skin barrier—regulating immunity," thus solving the technical problems of existing traditional Chinese medicine composition formulations lacking systematic optimization and having unstable efficacy. Validated in an animal model of acute eczema, all dosage groups of the traditional Chinese medicine composition of this invention significantly improved skin lesion symptoms, with the high-dose group showing better therapeutic effects than commonly used positive control drugs. Simultaneously, by downregulating serum pro-inflammatory factor levels, its anti-inflammatory mechanism was confirmed at the molecular level, demonstrating its therapeutic advantage of addressing both the symptoms and the root cause.

[0040] This invention establishes a standardized preparation process, employing specific parameters such as double-volume water soaking and reflux extraction, secondary extraction, and vacuum concentration. This overcomes the shortcomings of existing technologies, including crude preparation processes, low extraction rates of active ingredients, and unstable product quality. Quality testing shows that the active ingredient content in the formulation of this invention is stable, microbial limits meet standards, and the quality remains stable after 24 months of sealed storage at room temperature. This invention can be formulated into various dosage forms, including topical liquids and creams, suitable for both exudative and dry phases of eczema. It is convenient to use, has high patient compliance, and provides clinical practice with a scientifically formulated, technologically advanced, effective, and safe treatment for acute eczema.

[0041] Furthermore, this invention aims to address the pain points in current clinical treatment of uncomplicated vaginitis, such as "emphasizing sterilization over repair, high recurrence rate, and poor patient compliance." It combines the principles of traditional Chinese medicine's "holistic conditioning and syndrome differentiation" with modern medical understanding of vaginal microecological balance to provide a safe and effective treatment plan that balances pathogen elimination and vaginal mucosal barrier repair. This addresses the limitations of existing treatments, improves patient prognosis, and enhances quality of life. It has the following advantages: 1. Better results achieved: The results of specific embodiments of the present invention show that the traditional Chinese medicine composition provided by the present invention, at high doses, has a relief effect and antibacterial effect comparable to the commercially available product Fuyanjie. Therefore, the present invention, by optimizing the principal-assistant-adjuvant relationship and creatively using the two traditional Chinese medicines Polygonum cuspidatum and Zanthoxylum bungeanum, achieves a better effect than the commercially available product Fuyanjie.

[0042] 2. Overcoming the limitations of antibiotic / antifungal drug treatment: Addressing the problem that current clinical treatments for infectious uncomplicated vaginitis often lead to the development of drug-resistant strains, disruption of the vaginal lactobacillus community, and subsequent microecological imbalance, resulting in a vicious cycle of "treatment-relapse," this invention screens natural Chinese herbal ingredients with heat-clearing, dampness-removing, detoxifying, and antibacterial effects. While precisely inhibiting pathogenic bacteria (such as Gardnerella vaginalis, Candida albicans, and Trichomonas vaginalis), it minimizes damage to normal vaginal lactobacilli, avoiding the risk of drug resistance and achieving a "bacterial inhibition without harm" therapeutic effect.

[0043] 3. Achieving dual repair of the vaginal mucosal barrier and microecology: Addressing the issues of vaginal mucosal congestion and edema, thinning, and decreased elasticity in patients with simple vaginitis (especially postmenopausal atrophic vaginitis), as well as mucosal irritation and damage in patients with non-infectious vaginitis, this invention combines traditional Chinese medicines that strengthen the spleen and kidneys, nourish blood and moisten yin. This not only relieves surface symptoms such as vulvar and vaginal itching, burning sensation, and abnormal discharge, but also regulates the body's organ functions from the perspective of traditional Chinese medicine's "prevention of disease" approach—such as strengthening the spleen and removing dampness to reduce dampness accumulation, tonifying the kidneys and replenishing essence to improve mucosal atrophy caused by decreased hormone levels after menopause. Simultaneously, it provides a suitable environment for the growth of vaginal lactobacilli, promotes the restoration of the vaginal acidic environment (pH 3.8-4.5), fundamentally enhances the vagina's own resistance, and reduces the recurrence rate.

[0044] 4. Improve treatment convenience and patient compliance: Addressing the issues of existing topical medications (such as suppositories and ointments) requiring discontinuation during menstruation, strong local irritation, and the cumbersome procedures and difficulty in precise dosage control of traditional Chinese medicine fumigation and sitz baths, this invention optimizes the formulation process to prepare oral tablets, granules, or convenient topical preparations (such as mild gels, effervescent tablets, lotions, suppositories, or sprays). This ensures stable release of the active ingredients while simplifying the medication process (e.g., oral preparations avoid the inconvenience of topical medications, and topical preparations reduce mucosal irritation), adapting to different patient scenarios (e.g., reproductive age, postmenopausal), and improving long-term treatment compliance.

[0045] 5. Covering the Treatment Gap for Non-Infectious Simple Vaginitis: Addressing the clinical problem that current treatments for non-infectious simple vaginitis caused by vaginal microecological imbalance, local allergies (such as irritation from sanitary products), and mucosal barrier damage primarily focus on symptomatic relief of itching, lacking targeted repair methods, this invention utilizes the synergistic effect of multiple components of a traditional Chinese medicine compound. On one hand, it alleviates immediate discomfort through heat-clearing and itching-relieving components; on the other hand, it enhances the vaginal mucosal barrier function and improves local microcirculation through qi-tonifying, blood-nourishing, and mucosal-repairing components, achieving precise treatment of non-infectious inflammation and filling a gap in clinical treatment.

[0046] 6. Inheriting and Innovating Traditional Chinese Medicine Treatment Concepts: Based on the TCM understanding of the pathogenesis of simple vaginitis as "leukorrhea" and "vaginal itching" (such as damp-heat accumulation, spleen deficiency with dampness, and kidney yin deficiency), this invention optimizes the formulation of classic prescriptions, avoiding the problems of "poor suitability for syndrome types and lack of standardized verification of efficacy" in traditional empirical prescriptions. By clarifying the composition and dosage range of medicinal materials and standardizing the preparation process, the prescription can not only reflect the holistic conditioning advantages of TCM's "syndrome differentiation and treatment" but also meet the requirements of modern medicine for drug safety, efficacy, and stability, providing a standardized and scalable solution for the integrated treatment of simple vaginitis using TCM and Western medicine.

[0047] 7. Low cost: The Coptis chinensis used in this invention is cheaper than Phellodendron chinense. Results from specific embodiments of this invention show that the composition provided by this invention can achieve better results than Fuyanjie (a traditional Chinese medicine) while reducing costs. Attached Figure Description

[0048] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0049] Figure 1 Venn diagram of common drug-disease targets; Figure 2 Disease-Drug-Ingredient-Target Network Diagram; Figure 3 PPI network diagram; Figure 4 Bar chart for GO enrichment analysis; Figure 5 A bubble chart of the KEGG Pathway; Figure 6 Visualization results of molecular docking; Figure 7 Phenotypic images of the skin condition on the backs of mice in each group on day 0 and day 14 of treatment; Figure 8 This is a statistical chart showing the changes in dorsal skin lesion scores of mice in each group during the treatment period; Figure 9 A statistical graph showing the levels of IL-1β (A), IL-6 (B), IL-4 (C), TNF-α (D), IFN-γ (E), and IL-10 (F) in the serum of mice in each group as detected by ELISA. Figure 10 A flowchart for injecting estradiol into mice; where A is skin preparation and disinfection, B is subcutaneous injection of estradiol, and C is completion of injection. Figure 11 A flowchart for injecting Candida albicans into mice; where A represents the injection of Candida albicans, with an injection volume of 20 μL / mouse, and B represents the completion of the injection. Figure 12 A flowchart for administering medication to mice; where A represents vaginal administration of the intervention drug, and B represents completion of the injection. Figure 13 Images of mouse vulvas at different time points; Figure 14 Images of mouse vulvas at different time points; Figure 15 This refers to the level of IL-6 secretion. Figure 16 This refers to the level of IL-8 secretion. Figure 17 This is a graph showing the changes in mouse body weight. Figure 18 The colonization concentration of Candida albicans ATCC10231 in the mouse vagina; Figure 19 The results of smearing the vaginal irrigation fluid of Candida albicans ATCC10231 mice on a plate. Figure 20 PCA analysis of vaginal tissue from Candida albicans ATCC10231 mice; Figure 21 Statistical graph showing the differential expression levels of Candida albicans ATCC10231 in vaginal tissues of mice; Figure 22 Volcano plot showing the differential expression levels of Candida albicans ATCC10231 in the vaginal tissue of mice; Figure 23 Volcano plot showing the differential expression levels of Candida albicans ATCC10231 in mouse vaginal tissue. Detailed Implementation

[0050] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0051] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0052] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0053] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0054] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0055] Treatment of acute eczema: Example 1: Screening and Optimization of Traditional Chinese Medicine Composition Formulations Based on Network Pharmacology and Molecular Docking This embodiment first employs network pharmacology and molecular docking technology to systematically screen candidate Chinese herbal raw materials and their active ingredients in order to identify their core targets and key pathways for treating acute eczema, thereby guiding the optimization of formulation compatibility.

[0056] 1. Screening of candidate Chinese medicinal materials Based on the traditional Chinese medicine principles of "clearing heat and dampness, dispelling wind and relieving itching" in treating eczema, and combined with reports from modern pharmacological research, candidate Chinese herbal raw materials with anti-inflammatory, anti-allergic, immunomodulatory, and skin barrier repair-promoting effects were initially selected. The active ingredients of the aforementioned herbs were collected using the Traditional Chinese Medicine Systems Pharmacology Database and Analysis Platform (TCMSP, https: / / tcmsp-e.com / ), and candidate active ingredients were obtained based on oral bioavailability (OB) ≥30% and drug-likeness (DL) ≥0.18. The targets of each active ingredient were predicted in the TCMSP database. The target information of each herb was merged and duplicates were removed, resulting in a total of 451 drug targets.

[0057] 2. Disease target collection and acquisition of intersection targets Using "Acute eczema" as the search keyword, we searched for targets related to acute eczema in the GeneCards database (https: / / www.genecards.org) and the online human Mendelian Inheritance Database (OMIM, https: / / omim.org). After integrating the disease targets obtained from the two databases and removing duplicates, a total of 1297 targets related to acute eczema were identified.

[0058] The Venny 2.1.0 online tool was used to find the intersection between the active ingredient targets and disease targets of candidate traditional Chinese medicine raw materials to obtain common targets. The results showed that there were 92 overlapping targets between the drug targets and disease targets. Figure 1 ).

[0059] 3. Network pharmacology analysis 3.1 Construction of the "Disease-Drug-Ingredient-Target" Network The active ingredients and overlapping targets of candidate traditional Chinese medicine raw materials were imported into Cytoscape 3.10.1 software to construct an interaction network diagram of "disease-drug-ingredient-target". The network contains 133 nodes and 497 interaction connections. Based on the degree value of each node, the main active ingredients for treating acute eczema were screened. The top two active ingredients in terms of degree value were MOL000098 (Degree=31) and MOL007245 (Degree=31). Figure 2 ).

[0060] 3.2 Construction of Protein-Protein Interaction (PPI) Network and Screening of Core Targets Ninety-two intersection targets were imported into the STRING database (https: / / cn.stringdb.org / ), with the research species set to "Homo sapiens" and the minimum required interaction score set to medium confidence (0.4000) to analyze the interactions between targets. The obtained PPI network data was imported into Cytoscape 3.10.1 software for visualization analysis, resulting in a PPI network graph containing 89 nodes and 749 edges. Nodes were sorted according to their degree values, with higher degree values ​​indicating a more important role for the target in the network. The top two core targets with the highest degree values ​​were selected as AKT1 (Degree=60) and SRC (Degree=53). Figure 3 ).

[0061] 3.3 GO Functional Enrichment Analysis Ninety-two intersection targets were imported into the Metascape database (https: / / metascape.org / ), and the gene species was set to "Homo sapiens" for GO functional enrichment analysis. Based on the p-value, the top 10 enrichment results from each of the biological process (BP), cellular component (CC), and molecular function (MF) categories were selected for visualization analysis. Figure 4 ).

[0062] 3.4 KEGG pathway enrichment analysis KEGG pathway enrichment analysis was performed on 92 intersecting targets using the Metascape database, and statistically significant signaling pathways were selected based on p-values. The top 20 pathways were sorted by the number of targets involved and a bubble chart was generated. Figure 5 ).

[0063] 4. Molecular docking verification To further verify the reliability of the network pharmacology screening results, molecular docking verification was performed on the core targets (AKT1, SRC) and core active ingredients (MOL000098, MOL007245) obtained from the above screening.

[0064] 4.1 Ligand and Receptor Preparation Using the core active ingredients MOL000098 and MOL007245 as ligands, their molecular structure files (MOL2 format) were downloaded from the TCMSP database. Using the core targets AKT1 and SRC as protein receptors, the three-dimensional structure files (PDB format) of the corresponding target proteins were searched for and downloaded from the PDB database (https: / / www.rcsb.org / ).

[0065] 4.2 Molecular docking operation The ligand and receptor protein structures described above were imported into the CB-DOCK2 online platform (https: / / cadd.labshare.cn / cb-dock2) for Auto Blind Docking. The docking results were evaluated using binding energy (kcal / mol); a lower binding energy indicates a stronger affinity between the ligand and receptor.

[0066] 4.3 Molecular docking results Molecular docking results showed that the binding energy of MOL000098 to AKT1 was -9.1 kcal / mol, and the binding energy to SRC was also -9.1 kcal / mol; the binding energy of MOL007245 to AKT1 was -9.1 kcal / mol, and the binding energy to SRC was -7.9 kcal / mol (see Table 1). All docking binding energies were less than -5 kcal / mol, indicating good binding activity between the core active ingredient and the core target, validating the reliability of the network pharmacology screening results. Figure 6 ).

[0067] Table 1. Molecular docking binding energy (kcal / mol) for each target site Based on the above screening results, using herbs containing MOL000098 and MOL007245 as the basis for the formulation, and combining the compatibility experience of each herb in traditional prescriptions, the formulation of a traditional Chinese medicine composition with synergistic effects was further determined through the addition or subtraction of herbs and optimization of dosage ratios. This formulation, while ensuring the effective enrichment of the core active ingredients, also needs to take into account the multi-target synergistic effects of clearing heat and reducing inflammation, dispelling wind and relieving itching, repairing the skin barrier, and regulating immunity.

[0068] Example 2: A traditional Chinese medicine composition for treating acute eczema Preparation of materials: By weight, the ingredients are: 120 parts Polygonum cuspidatum, 120 parts Coptis chinensis, 80 parts Sophora flavescens, 30 parts Portulaca oleracea, 10 parts Zanthoxylum bungeanum, 20 parts Stemona japonica, 3 parts Menthol, and 3 parts Borneol; and by weight, the ingredients are: 120g Polygonum cuspidatum, 120g Coptis chinensis, 80g Sophora flavescens, 30g Portulaca oleracea, 10g Zanthoxylum bungeanum, 20g Stemona japonica, 3g Menthol, and 3g Borneol.

[0069] Preparation of topical stock solution formulation: (1) Raw material pretreatment Solid raw material processing: Remove impurities and clean the Polygonum cuspidatum, Coptis chinensis, Sophora flavescens, Portulaca oleracea, Stemona japonica and Zanthoxylum bungeanum, place them in a 60℃ oven to dry to constant weight, pulverize to 40-60 mesh coarse powder (in this example, pulverize to 60 mesh), mix evenly to obtain mixed coarse powder; Treatment of volatile components: Grind borneol and menthol into fine powder (80-100 mesh, 80 mesh in this example) separately, seal and store for later use to avoid loss due to volatilization.

[0070] (2) Standardized water extraction process (for non-volatile raw materials) First extraction: Take the mixed coarse powder, add 9-10 times its weight of distilled water (9 times in this example), soak for 0.5-1.5 hours (1.5 hours in this example), heat to boiling, and reflux for 1.5-2.5 hours (2.5 hours in this example). After extraction, filter through a 100-mesh sieve from the pharmacopoeia and collect the first extract. Second extraction: Add 7-9 times the weight of distilled water to the filtered residue (7 times in this example), heat again to boiling, and reflux for 1.5-2.5 hours while maintaining a gentle boil (2.5 hours in this example). After extraction, filter again through a 100-mesh sieve from the pharmacopoeia and collect the second extract. Merging and Concentration: The two extracts are thoroughly mixed and placed in a vacuum concentrator. The mixture is concentrated under reduced pressure at 60°C and -0.08MPa to 1 / 5 to 1 / 4 of the original volume (in this example, it is concentrated to 1 / 5 of the original volume) to obtain the original Chinese medicine liquid. The concentrated Chinese medicine liquid is then cooled to below 40°C.

[0071] (3) Formulation (including the addition of volatile components) Finely ground borneol powder and menthol powder are added to the cooled Chinese herbal extract and stirred quickly until fully dissolved. Then, 0.1-0.2% (w / v) (0.1% in this example) of potassium sorbate is added as a preservative, and 3-5% (v / v) (5% in this example) of glycerin is added as a humectant. After stirring and dissolving, the mixture is sterilized by flowing steam at 100°C for 20 minutes, cooled, and then packaged to obtain the external application stock solution of the Chinese herbal composition.

[0072] Example 3: A traditional Chinese medicine composition for treating acute eczema Preparation of materials: By weight, the ingredients are: 80 parts Polygonum cuspidatum, 80 parts Coptis chinensis, 120 parts Sophora flavescens, 70 parts Portulaca oleracea, 20 parts Zanthoxylum bungeanum, 40 parts Stemona japonica, 7 parts Menthol, and 7 parts Borneol; or by weight, the ingredients are: 80g Polygonum cuspidatum, 80g Coptis chinensis, 120g Sophora flavescens, 70g Portulaca oleracea, 20g Zanthoxylum bungeanum, 40g Stemona japonica, 7g Menthol, and 7g Borneol.

[0073] Preparation of topical stock solution formulation: (1) Raw material pretreatment Solid raw material processing: Remove impurities and clean the Polygonum cuspidatum, Coptis chinensis, Sophora flavescens, Portulaca oleracea, Stemona japonica and Zanthoxylum bungeanum, place them in a 60℃ oven to dry to constant weight, pulverize them to 40 mesh coarse powder, mix them evenly to obtain mixed coarse powder; Treatment of volatile components: Grind borneol and menthol into 100-mesh fine powder separately, seal and store for later use to avoid loss due to volatilization.

[0074] (2) Standardized water extraction process (for non-volatile raw materials) First extraction: Take the mixed coarse powder, add 10 times its weight of distilled water, soak for 0.5 hours, heat to boiling, and reflux for 1.5 hours while maintaining a gentle boil. After extraction, filter through a 100-mesh sieve from the pharmacopoeia and collect the first extract. Second extraction: Add 9 times the weight of distilled water to the filtered residue, heat to boiling again, and reflux for 1.5 hours while maintaining a gentle boil. After extraction, filter through a 100-mesh sieve as described in the pharmacopoeia and collect the second extract. Merging and Concentration: The two extracts are thoroughly mixed and placed in a vacuum concentrator. The mixture is concentrated to 1 / 4 of its original volume under reduced pressure at 60℃ and -0.08MPa to obtain the original Chinese medicine liquid. The concentrated Chinese medicine liquid is then cooled to below 40℃.

[0075] (3) Formulation (including the addition of volatile components) Finely ground borneol powder and menthol powder were added to the cooled Chinese herbal extract and stirred quickly until fully dissolved. Then, 0.2% (w / v) potassium sorbate was added as a preservative and 3% (v / v) glycerin was added as a humectant. After stirring and dissolving, the mixture was sterilized by flowing steam at 100°C for 20 minutes, cooled, and packaged to obtain the Chinese herbal extract for external use.

[0076] Example 4: A traditional Chinese medicine combination for treating acute eczema Preparation of materials: By weight, the ingredients are: 120 parts Polygonum cuspidatum, 120 parts Coptis chinensis, 80 parts Sophora flavescens, 30 parts Portulaca oleracea, 10 parts Zanthoxylum bungeanum, 20 parts Stemona japonica, 3 parts Menthol, and 3 parts Borneol; and by weight, the ingredients are: 120g Polygonum cuspidatum, 120g Coptis chinensis, 80g Sophora flavescens, 30g Portulaca oleracea, 10g Zanthoxylum bungeanum, 20g Stemona japonica, 3g Menthol, and 3g Borneol.

[0077] Preparation of topical cream formulations: The preparation was further prepared based on the topical formulation of the traditional Chinese medicine composition prepared in Example 2.

[0078] (1) Preparation of oil phase: Take 15g of petrolatum, 10g of stearic acid and 5g of lanolin, put them in an oil phase preparation tank, heat to 75℃, stir to completely melt and mix the components evenly, and keep the temperature at 75℃ for later use. (2) Take 30g of the external preparation of the traditional Chinese medicine composition prepared in Example 2 above, add 3g of triethanolamine, heat to 75°C, stir evenly, so that the triethanolamine and the traditional Chinese medicine are fully mixed, and keep at a constant temperature of 75°C for later use. (3) Emulsification and molding: The aqueous phase is slowly added to the oil phase while stirring. The emulsification is carried out at 75°C for 30 minutes. When the temperature is cooled to 45°C, if borneol and menthol have not been added in advance, their fine powder can be added at this stage. Continue stirring until room temperature is reached to form a uniform and delicate cream. After sterilization, the cream is packaged to obtain the topical cream preparation of the traditional Chinese medicine composition.

[0079] The quality of the topical liquid and cream formulations of the traditional Chinese medicine compositions prepared in Examples 2-4 above was tested, and the results are as follows: The properties were examined by visual inspection combined with olfactory inspection: the external liquid preparation of the Chinese herbal composition was a brownish-black to dark brown liquid with a fragrant odor (smell of borneol and menthol) and a slightly bitter taste; the external cream preparation of the Chinese herbal composition was a pale yellow to brownish-yellow uniform cream with a fragrant odor and was easily absorbed after application.

[0080] The content of active ingredients was determined by high performance liquid chromatography (HPLC): In the topical liquid preparation of the traditional Chinese medicine composition, the content of emodin (from Polygonum cuspidatum) was not less than 0.20 mg / mL, the content of berberine (from Coptis chinensis) was not less than 0.18 mg / mL, and the content of matrine (from Sophora flavescens) was not less than 0.15 mg / mL. In the topical cream preparation of the traditional Chinese medicine composition, the content of emodin (from Polygonum cuspidatum) was not less than 0.06 mg / g, the content of berberine (from Coptis chinensis) was not less than 0.05 mg / g, and the content of matrine (from Sophora flavescens) was not less than 0.045 mg / g.

[0081] Microbial limits: For liquid dosage forms, bacterial count ≤100 CFU / mL, mold and yeast count ≤10 CFU / mL; for creams, bacterial count ≤10 CFU / g, mold and yeast count ≤5 CFU / g; no pathogenic bacteria were detected in any of them. Stability: After 24 months of sealed storage at room temperature, the properties, content of active ingredients and microbial limits all meet the above standards.

[0082] Example 5: Pharmacological Verification of the Traditional Chinese Medicine Composition To verify the therapeutic effect and mechanism of action of the traditional Chinese medicine composition of the present invention on acute eczema, this embodiment uses a mouse acute eczema model induced by 2,4-dinitrochlorobenzene (DNCB), with 3% boric acid solution and 3% Jieeryin solution as positive control drugs, to evaluate the effect of different dose groups of the traditional Chinese medicine composition of the present invention on improving skin lesion symptoms and regulating inflammatory factors in mice with acute eczema.

[0083] 1. Laboratory animals SPF-grade male BALB / c mice, weighing 18-22g, were acclimatized for one week under the following conditions: free access to food and water, temperature 22±2℃, humidity 50%±10%, and a 12-hour light / 12-hour dark cycle.

[0084] 2. Drugs and reagents Traditional Chinese medicine composition drug solution: The traditional Chinese medicine composition external application stock solution was prepared according to the method of Example 3 as the high-dose group drug solution; the traditional Chinese medicine composition external application stock solution was diluted with PBS buffer to 75% and 50% of the stock solution concentration, respectively, as the medium-dose group and low-dose group drug solutions.

[0085] Positive control drug: 3% boric acid solution (preparation: weigh 3g of boric acid, add purified water to dissolve and make up to 100mL); dilute with purified water to a 3% concentration of commercially available Jieeryin solution.

[0086] Modeling reagents: 2,4-dinitrochlorobenzene (DNCB); acetone (analytical grade); olive oil (analytical grade).

[0087] Detection reagents: Mouse IL-1β, IL-6, IL-4, TNF-α, IFN-γ and IL-10 ELISA kit.

[0088] I. Experimental Methods 1. Establishment of an acute eczema model After one week of acclimatization, all mice except the blank control group were induced with DNCB to establish an acute eczema model.

[0089] Preparation before modeling: One day before the experiment (d0), use scissors and hair removal cream to remove approximately 2cm × 2cm of mouse hair from the back of the mouse to expose the skin, taking care to avoid damaging the skin.

[0090] Modeling operation: Sensitization phase: Starting from day 1 (d1), 50 μL of 5% DNCB acetone solution was applied to the exposed skin on the back of the mice once a day for 3 consecutive days (d1-d3).

[0091] Settling phase: No treatment was performed on day 4 of the experiment (d4).

[0092] Triggering phase: Hair was removed again on day 5 (d5); starting from day 6 (d6), 50 μL of 1% DNCB acetone solution was applied to the exposed skin on the back of the mice once a day for 5 consecutive days (d6-d10).

[0093] If, after 24 hours of application, the mice show typical signs of acute eczema such as redness, swelling, papules, exudation, and crusting on their backs, then the modeling is considered successful.

[0094] 2. Animal grouping and administration The 72 mice that successfully developed the model were randomly divided into 6 groups of 12 mice each, and a blank control group of 12 mice was set up, for a total of 7 groups. The specific grouping and drug administration regimens are shown in Table 2.

[0095] Table 2 Specific groupings and dosing regimens Drug administration began on day 11 after successful model establishment. During administration, the mice's limbs were fixed, and a 2.5cm × 1.5cm sterile gauze was folded into 6 layers (3 layers were folded once to form a 5cm × 1.5cm gauze) and placed on the skin lesion on the mouse's back. The appropriate amount of medication was drawn into a syringe and dripped onto the gauze until it was moist but not dripping, for immersion treatment. Each treatment lasted 20 minutes, once daily, for 14 consecutive days (days 11-24). The control group and the model group received an equal volume of PBS solution for immersion.

[0096] 3. Skin lesion score During the treatment period, the skin lesions on the backs of mice were observed and recorded daily, and a double-blind method was used to score the skin lesions. The scoring criteria were based on the Clinical Eczema Area and Severity Index (EASI) scoring criteria, which comprehensively assessed indicators such as erythema, papules, exudation, crusting, and edema. The total score ranged from 0 to 12 points, with higher scores indicating more severe skin lesions.

[0097] 4. Specimen Collection and Processing Specimens were collected from mice in each group 24 hours after the last treatment (d25): (1) Blood sample collection: peripheral blood was collected by enucleation, allowed to stand at room temperature for 1 hour, centrifuged at 3000r / min for 15 minutes, serum was separated, aliquoted and stored at -80℃ for later use.

[0098] (2) Skin tissue specimen collection: Use sterile surgical scissors to cut approximately 1cm × 1cm of skin tissue from the skin lesion on the back of the mouse, and immediately fix it in 10% neutral formaldehyde solution for subsequent histopathological examination.

[0099] 5. Serum inflammatory factor detection The levels of interleukin-1β (IL-1β), interleukin-6 (IL-6), and interleukin-8 (IL-8) in the serum of mice in each group were detected using enzyme-linked immunosorbent assay (ELISA). The specific procedures were strictly performed according to the ELISA kit instructions.

[0100] II. Experimental Results 1. Comparison of skin lesion scores among different groups of mice On day 0 and day 14 of treatment, the skin condition on the backs of mice in each group was as follows: Figure 7 As shown in the figure. The statistical analysis of changes in dorsal skin lesion scores in each group of mice during treatment is as follows. Figure 8 As shown.

[0101] Compared with the model group: From day 7 to day 14 of treatment, the back skin lesion scores of all treatment groups (boric acid group, Jieeryin group, and high, medium, and low dose traditional Chinese medicine groups) showed a significant decreasing trend. P<0.01 indicates that all therapeutic drugs can effectively improve the skin lesion symptoms in mice with acute eczema.

[0102] Compared with the boric acid group: From day 8 to day 14 of treatment, the back skin lesion scores of the Jieeryin group and the high, medium and low dose groups of traditional Chinese medicine all showed a significant downward trend (###P<0.001), indicating that the therapeutic effects of each dose group of the traditional Chinese medicine composition of the present invention and the Jieeryin group were significantly better than those of the boric acid group.

[0103] Compared with the Jieeryin group: From day 8 to day 14 of treatment, the back skin lesion scores of the high, medium and low dose groups of traditional Chinese medicine all showed a significant downward trend (^^P<0.01), indicating that the therapeutic effect of each dose group of the traditional Chinese medicine composition of the present invention is significantly better than that of the Jieeryin group.

[0104] Compared with the medium-dose group of traditional Chinese medicine (TCM): From day 7 to day 14 of treatment, the back skin lesion scores of both the high-dose TCM group and the Jieeryin group showed a decreasing trend. Specifically, on days 7, 10, 11, 12, and 13 of treatment, the differences between the high-dose and medium-dose groups were extremely significant (+++P<0.001); on days 8 and 9, the differences were significant (++P<0.01). This indicates that the treatment effect of the high-dose TCM group was significantly better than that of the medium-dose group.

[0105] Compared with the low-dose traditional Chinese medicine (TCM) group: From day 7 to day 14 of treatment, the back skin lesion scores of the high- and medium-dose TCM groups and the Jieeryin group all showed a decreasing trend. Specifically, on days 7, 10, 11, 12, and 13 of treatment, the differences between the high- and medium-dose TCM groups and the low-dose group were extremely significant (&&&P<0.001); on days 8 and 9 of treatment, the differences were significant (&&P<0.01). This indicates that the treatment effects of the high- and medium-dose TCM groups were significantly better than those of the low-dose group, and this effect showed a dose-dependent relationship.

[0106] 2. Comparison of serum inflammatory factor levels in mice of different groups The levels of IL-1β, IL-6, IL-4, TNF-α, IFN-γ, and IL-10 in the serum of mice in each group were detected by ELISA. The results are as follows: Figure 9 As shown.

[0107] IL-1β levels: Compared with the boric acid group, Jieeryin group, medium-dose group, and low-dose group of traditional Chinese medicine, the IL-1β levels in the high-dose group of traditional Chinese medicine showed a significant decreasing trend (P<0.05 or P<0.01). There were also significant differences between the medium-dose group of traditional Chinese medicine and the boric acid group, Jieeryin group, and low-dose group of traditional Chinese medicine (P<0.05). This indicates that the inhibitory effect of the traditional Chinese medicine composition of the present invention on IL-1β is dose-dependent, and the high-dose group of traditional Chinese medicine has the most significant inhibitory effect.

[0108] IL-6 levels: The IL-6 levels in the high-dose traditional Chinese medicine group were significantly lower than those in the boric acid group, the Jieeryin group, and the medium and low-dose traditional Chinese medicine groups (P<0.01). The medium-dose traditional Chinese medicine group was significantly lower than that in the boric acid group, the Jieeryin group, and the low-dose traditional Chinese medicine group (P<0.05). This shows that the traditional Chinese medicine composition can dose-dependently downregulate serum IL-6 levels, with the high-dose group showing the best regulatory effect.

[0109] IL-4 levels: The IL-4 levels in the high- and medium-dose groups of traditional Chinese medicine were significantly lower than those in the boric acid group, the Jieeryin group, and the low-dose group of traditional Chinese medicine (P<0.05 or P<0.01). The downregulation effect was more significant in the high-dose group. There was no significant difference between the low-dose group of traditional Chinese medicine and the positive control group. This suggests that the traditional Chinese medicine composition can regulate IL-4 expression in a dose-dependent manner and improve the immune disorder state of eczema.

[0110] TNF-α level: The TNF-α level in the high-dose group of traditional Chinese medicine was significantly lower than that in other treatment groups (P<0.01), and the level in the medium-dose group of traditional Chinese medicine was significantly lower than that in the boric acid group, the Jieeryin group, and the low-dose group of traditional Chinese medicine (P<0.05), indicating that the traditional Chinese medicine composition of the present invention can effectively inhibit the release of pro-inflammatory factor TNF-α, and the high-dose group has the most significant inhibitory effect.

[0111] IFN-γ level: The IFN-γ level in the high-dose group of traditional Chinese medicine was significantly lower than that in the boric acid group, the Jieeryin group, and the medium and low-dose groups of traditional Chinese medicine (P<0.01). The medium-dose group of traditional Chinese medicine was also significantly lower than that in the boric acid group, the Jieeryin group, and the low-dose group of traditional Chinese medicine (P<0.05). This indicates that the traditional Chinese medicine composition of the present invention can effectively downregulate the IFN-γ level, and the regulatory effect increases with increasing dosage.

[0112] IL-10 levels: The IL-10 levels in the high-dose traditional Chinese medicine group were significantly higher than those in the boric acid group, the Jieeryin group, and the medium and low-dose traditional Chinese medicine groups (P<0.01). The medium-dose traditional Chinese medicine group was significantly higher than that in the boric acid group, the Jieeryin group, and the low-dose traditional Chinese medicine group (P<0.05). This indicates that the traditional Chinese medicine composition of the present invention can effectively upregulate the expression of the anti-inflammatory factor IL-10, and the upregulating effect increases with increasing dosage, with the high-dose group showing the most prominent effect.

[0113] In summary, the traditional Chinese medicine composition of this invention can bidirectionally regulate the levels of inflammatory factors in the serum of mice with acute eczema, significantly reduce the content of pro-inflammatory factors such as IL-1β, IL-6, IL-4, TNF-α, and IFN-γ, and effectively increase the expression of anti-inflammatory factor IL-10, thereby improving the inflammatory response and immune imbalance in the model mice. Moreover, the regulatory effect on each inflammatory factor shows a clear dose-dependent effect, with the high-dose group of traditional Chinese medicine showing the most significant regulatory effect.

[0114] Treatment of uncomplicated vaginitis: Example 6: External suppositories for treating uncomplicated vaginitis Preparation of materials: By weight, the ingredients are: 120 parts Polygonum cuspidatum, 120 parts Coptis chinensis, 80 parts Sophora flavescens, 30 parts Portulaca oleracea, 10 parts Zanthoxylum bungeanum, 20 parts Stemona japonica, 3 parts Menthol, and 3 parts Borneol; and by weight, the ingredients are: 120g Polygonum cuspidatum, 120g Coptis chinensis, 80g Sophora flavescens, 30g Portulaca oleracea, 10g Zanthoxylum bungeanum, 20g Stemona japonica, 3g Menthol, and 3g Borneol.

[0115] Preparation method: 1. Pre-treatment of medicinal materials: Take Polygonum cuspidatum, Portulaca oleracea, Sophora flavescens, Coptis chinensis, Zanthoxylum bungeanum and Stemona japonica, remove impurities and grind them into coarse powder (pass through a 10-mesh sieve), mix them evenly to obtain mixed coarse powder; 2. Soaking treatment: Add 3 to 5 times the total weight of the mixed coarse powder to purified water (in this example, the amount of purified water is 5 times the total mass of the mixed coarse powder), and soak at room temperature for 30 to 60 minutes (in this example, the soaking time is 30 minutes) to allow the medicinal materials to fully absorb water and improve the dissolution rate of the active ingredients; 3. First decoction treatment: Transfer the soaked mixed coarse powder and water into a decoction pot, bring to a boil over high heat, then reduce to low heat (temperature controlled between 80~90℃), and simmer for 30~45 minutes (the boiling time in this embodiment is 45 minutes). Filter while hot (using a 100-mesh filter) and collect the first decoction liquid and dregs. 4. Second decoction treatment: Add 3 to 8 times the weight of the dregs of purified water to the dregs (in this example, the amount of purified water is 8 times the weight of the dregs), repeat the first decoction steps (bring to a boil over high heat and then simmer over low heat for 20 to 30 minutes (in this example, the decoction time is 30 minutes)), filter and collect the second decoction. 5. Concentration and Blending Process: Combine the two decoctions and concentrate under reduced pressure (temperature 60~70℃ (65℃ in this example), vacuum degree -0.08~-0.06MPa (-0.08MPa in this example)) to obtain a clear extract with a relative density of 1.10~1.20 (measured at 60℃); then vacuum dry (temperature 50~60℃ (60℃ in this example), vacuum degree -0.08MPa) to obtain a dry extract, pulverize it into a fine powder (pass through an 80-mesh sieve), and set aside for later use; 6. Melting the matrix: Take semi-synthetic fatty acid glycerides (suppository matrix, the amount is 3 to 5 times the weight of the Chinese herbal powder (in this example, the amount of semi-synthetic fatty acid glycerides is 3 times the weight of the Chinese herbal powder)), place it in a water bath and heat to melt (temperature 50-60℃ (in this example, the temperature is 55℃) to avoid high temperature destroying the active ingredients); 7. Mixing and pouring: Add fine powder of Chinese medicine, menthol (crushed through a 100-mesh sieve), and borneol (crushed through a 100-mesh sieve) to the melted matrix, and stir until evenly dispersed; quickly pour the mixture into suppository molds (e.g., 2g / suppository), let it cool naturally to room temperature (or place it in a 4℃ refrigerator to cool for 10-15 minutes), and demold it after it has completely solidified; 8. Packaging and sterilization: The molded suppositories are packaged in aluminum-plastic blister packs and sterilized by flowing steam (100℃, 30 minutes) to obtain external suppositories (each suppository contains 0.5~1g of raw herbs, which is in line with the clinical single-dose dosage).

[0116] When the traditional Chinese medicine composition and drug provided by this invention are used clinically, the medication regimen can be adjusted according to the patient's specific syndrome (e.g., for trichomonal vaginitis, the frequency of use of the wash can be increased, and for fungal vaginitis, suppositories can be preferred to prolong the efficacy). Moreover, there is no need to suspend daily activities during medication (suppositories can be suspended during menstruation, and external washes can be used for cleaning instead), and patients have a high acceptance rate.

[0117] Example 7: External wash for treating uncomplicated vaginitis Preparation of materials: By weight, the ingredients are: 120 parts Polygonum cuspidatum, 120 parts Coptis chinensis, 80 parts Sophora flavescens, 30 parts Portulaca oleracea, 10 parts Zanthoxylum bungeanum, 20 parts Stemona japonica, 3 parts Menthol, and 3 parts Borneol; and by weight, the ingredients are: 120g Polygonum cuspidatum, 120g Coptis chinensis, 80g Sophora flavescens, 30g Portulaca oleracea, 10g Zanthoxylum bungeanum, 20g Stemona japonica, 3g Menthol, and 3g Borneol.

[0118] Preparation method: 1. Pre-treatment of medicinal materials: Take Polygonum cuspidatum, Portulaca oleracea, Sophora flavescens, Coptis chinensis, Zanthoxylum bungeanum and Stemona japonica, remove impurities and grind them into coarse powder (pass through a 10-mesh sieve), mix them evenly to obtain mixed coarse powder; 2. Soaking treatment: Add purified water to the mixed coarse powder in a volume of 3 times its total weight, and soak at room temperature for 30 minutes to allow the medicinal materials to fully absorb water and improve the dissolution rate of active ingredients; 3. First decoction treatment: Transfer the soaked mixed coarse powder and water into a decoction pot, bring to a boil over high heat, then reduce to low heat (temperature controlled between 80~90℃), and simmer for 30 minutes. Filter while hot (using a 100-mesh filter) to collect the first decoction liquid and dregs. 4. Second decoction treatment: Add purified water with a weight of 3 times the dregs to the dregs, and repeat the first decoction steps (bring to a boil over high heat, then simmer over low heat for 20 minutes, filter and collect the second decoction). 5. Concentration and Blending: Combine the two decoctions and concentrate under reduced pressure (temperature 60℃, vacuum degree -0.06MPa) to obtain a clear extract with a relative density of 1.10~1.20 (measured at 60℃); after the clear extract cools to below 40℃, add menthol (pre-dissolved with a small amount of 99.5% ethanol to avoid clumping; in this example, the volume-to-mass ratio of 99.5% (v / v) ethanol to menthol is 5.5mL:5g) and borneol, and stir evenly; add water to make up to the specified volume (e.g., 20g of raw herb per 100mL), and dispense to obtain the external wash.

[0119] Example 8: External wash for treating uncomplicated vaginitis Preparation of materials: By weight, the ingredients are: 80 parts Polygonum cuspidatum, 80 parts Coptis chinensis, 120 parts Sophora flavescens, 70 parts Portulaca oleracea, 20 parts Zanthoxylum bungeanum, 40 parts Stemona japonica, 7 parts Menthol, and 7 parts Borneol; or by weight, the ingredients are: 80g Polygonum cuspidatum, 80g Coptis chinensis, 120g Sophora flavescens, 70g Portulaca oleracea, 20g Zanthoxylum bungeanum, 40g Stemona japonica, 7g Menthol, and 7g Borneol.

[0120] Preparation method: 1. Pre-treatment of medicinal materials: Take Polygonum cuspidatum, Portulaca oleracea, Sophora flavescens, Coptis chinensis, Zanthoxylum bungeanum and Stemona japonica, remove impurities and grind them into coarse powder (pass through a 10-mesh sieve), mix them evenly to obtain mixed coarse powder; 2. Soaking treatment: Add purified water to the mixed coarse powder at 4 times the total weight of the mixed coarse powder, soak at room temperature for 45 minutes to allow the medicinal materials to fully absorb water and improve the dissolution rate of active ingredients; 3. First decoction treatment: Transfer the soaked mixed coarse powder and water into a decoction pot, bring to a boil over high heat, then reduce to low heat (temperature controlled between 80~90℃), and simmer for 35 minutes. Filter while hot (using a 100-mesh filter) to collect the first decoction liquid and dregs. 4. Second decoction treatment: Add purified water at 5 times the weight of the dregs to the dregs, repeat the first decoction steps (bring to a boil over high heat and then simmer over low heat for 25 minutes), filter and collect the second decoction. 5. Concentration and Blending: Combine the two decoctions and concentrate under reduced pressure (temperature 70℃, vacuum degree -0.07MPa) to obtain a clear extract with a relative density of 1.10~1.20 (measured at 60℃); after the clear extract cools to below 40℃, add menthol (pre-dissolved with a small amount of 99.5% ethanol to avoid clumping; in this example, the volume-to-mass ratio of 99.5% (v / v) ethanol to menthol is 5.5mL:5g) and borneol, and stir evenly; add water to make up to the specified volume (e.g., 20g of raw herb per 100mL), and dispense to obtain the external wash.

[0121] Example 9 Antibacterial Experiment I. Experimental Preparation and Methods 1. Test reagents: External washes prepared in Examples 6, 7, and 8; an external wash lacking Polygonum cuspidatum (with the same components and preparation method, the only difference being the absence of this Chinese medicinal herb); water extracts of eight single herbs (Polygonum cuspidatum water extract, Portulaca oleracea water extract, Sophora flavescens water extract, Coptis chinensis water extract, Zanthoxylum bungeanum water extract, Stemona japonica water extract, Menthol, Borneol water extract); fluconazole solution; and Jieeryin solution. Polygonum cuspidatum, Coptis chinensis, Sophora flavescens, Portulaca oleracea, Stemona japonica, Zanthoxylum bungeanum, Borneol, and Menthol were all genuine medicinal materials conforming to the standards of the Pharmacopoeia of the People's Republic of China and were used after identification; fluconazole solution standard (purity ≥98%, National Drug Approval Number); and commercially available Jieeryin solution (National Drug Approval Number standard external preparation).

[0122] The preparation methods of water extracts from eight single Chinese medicinal herbs are as follows: 1) Take each single herb, remove impurities, pulverize and pass through a 40-mesh sieve, accurately weigh 100g of each herb powder and place them in 500mL Erlenmeyer flasks.

[0123] 2) Add 10 times the amount (w / v) of distilled water, soak at room temperature for 30 minutes, heat on an electric stove to boiling, keep simmering for 30 minutes, filter while hot through four layers of gauze, and collect the filtrate.

[0124] 3) Add 8 times the amount (w / v) of distilled water to the dregs, heat again to boiling, simmer for 20 minutes, filter through four layers of gauze, and collect the secondary filtrate.

[0125] 4) Combine the two filtrates and concentrate them under reduced pressure on a rotary evaporator to obtain a mother liquor with a crude drug concentration of 2 g / mL. Cool to room temperature.

[0126] 5) Since borneol and menthol have poor water solubility, take the above-mentioned water extract concentrate, add borneol and menthol dissolved in a small amount of anhydrous ethanol in proportion, stir quickly until completely mixed, and add sterile distilled water to the concentration of crude drug 2g / mL.

[0127] 6) Sterilize the mother liquor of each single herb water extract by filtering with a 0.22μm microporous membrane, dispense into sterile test tubes, and store at 4℃ for later use. Prepare and use immediately, with a shelf life of 48 hours.

[0128] 2. Experimental conditions: Experimental strain (Candida albicans ATCC10231, standard strain, frozen at -80℃, thawed and activated before experiment); bacterial concentration (0.5 McFarland turbidity, diluted to 1×10⁻⁶). 4 ~5×10 4CFU / mL); SDA solid medium (for inhibition zone determination) and RPMI-1640 liquid medium (for MIC determination) were both commercially available sterile products, prepared according to the instructions and sterilized for later use; culture conditions (35℃, 48h); detection methods (Oxford cup method, test tube two-fold dilution method) and positive / negative controls. The two groups of compositions, one containing Polygonum cuspidatum and one without Polygonum cuspidatum, were tested simultaneously to ensure the fairness and scientific nature of the comparison.

[0129] 3. Reagents and consumables: sterile physiological saline, anhydrous ethanol, 0.22μm microporous filter membrane, Oxford cup (inner diameter 6mm, outer diameter 8mm, height 10mm), test tubes, pipettes (100μL, 1mL), petri dishes (diameter 90mm), Erlenmeyer flasks (500mL), autoclave, laminar flow hood, constant temperature incubator, electronic balance (accuracy 0.001g), herbal medicine grinder, and medicine sieve (40 mesh).

[0130] 4. Test methods: 4.1 Recovery and activation of experimental strains Remove the Candida albicans ATCC10231 cryovial from the -80℃ ultra-low temperature freezer, quickly place it in a 37℃ constant temperature water bath for 5 minutes for rapid recovery, and under aseptic conditions take 100μL of bacterial solution and streak it onto an SDA solid medium plate.

[0131] Incubate the inoculation plate in a 35°C incubator for 24 hours. Select a single colony with typical morphology and no contamination from the plate and streak it onto a new SDA solid medium plate. Incubate at 35°C for 24 hours and continue to activate for 3 generations to ensure the stability of the strain activity.

[0132] Single colonies activated for three generations were collected and prepared into a bacterial suspension using sterile physiological saline. The suspension was then calibrated to 0.5 McFarland turbidity using a McFarland turbidimeter, at which point the bacterial concentration was approximately 1 × 10⁻⁶. 8 ~5×10 8 CFU / mL; for the inhibition zone assay, the bacterial suspension was diluted 100-fold with sterile physiological saline to a final concentration of 1×10⁻⁶. 4 ~5×10 4 CFU / mL; MIC should be serially diluted according to experimental requirements and used immediately.

[0133] 4.2 Determination of inhibition zone diameter (Oxford cup method) Take the sterilized SDA solid culture medium, heat it in a water bath to melt it, and then cool it to 45~50℃. In a clean bench, add 20mL to each culture dish (90mm in diameter), place it horizontally and wait for the culture medium to completely solidify to make a sterile plate. Let it stand at room temperature for 15min.

[0134] Take 100 μL of the diluted Candida albicans suspension (1×10⁻⁶) using a sterile pipette. 4~5×10 4 The bacterial solution (CFU / mL) was evenly spread on the surface of an SDA plate and placed in a clean bench to air dry at room temperature for 15 minutes to prevent the bacterial solution from flowing.

[0135] Use sterile forceps to pick up the Oxford cups that have been autoclaved at 121℃ for 20 minutes, and gently place them vertically on the surface of the plate with the bacterial solution. Ensure that the Oxford cups are in close contact with the culture medium without gaps. Place 4 Oxford cups on each plate in a regular quadrilateral arrangement, with a distance of ≥2cm between the cups to avoid interference from the diffusion of the solution.

[0136] Take 200 μL of the single herb aqueous extract mother liquor (2 g / mL) using a sterile pipette and slowly add it along the inner wall of an Oxford cup, ensuring the same amount is added to each cup to avoid spillage. At the same time, set up a positive control (fluconazole solution) and a negative control (sterile saline), and set up 3 parallel plates for each group and label them.

[0137] After adding the sample, the plate was placed at room temperature for 30 minutes to allow the drug solution to fully diffuse into the culture medium, and then placed in an incubator at 35°C and inverted for 48 hours.

[0138] After incubation, remove the plates and use calipers (accuracy 0.02mm) to measure the diameter of the inhibition zone around each Oxford cup. When measuring, take the average diameter of the inhibition zone in both vertical directions, accurate to 0.1mm, and record the data. The edge of the inhibition zone is judged by a clear boundary with no obvious colony growth.

[0139] 4.3 Test tube dilution method The predicted MIC range (0.0625~2.0 g / mL) for all single herbs and preparations was determined using the two-fold dilution method. This method referenced the "Antibacterial Effect of Aqueous Decoctions of Sophora flavescens and Sophora tonkinensis on Candida albicans" (China Biomedical Literature Service System, 2025), which clearly uses the Sabouraud dextrose medium two-fold dilution method to determine the MIC value of aqueous extracts of traditional Chinese medicine against Candida albicans. It also complies with the general specifications for determining the MIC value of fungi using the two-fold dilution method in the "Reference Methods for Antifungal Susceptibility Testing" (M27-A3 / M27-S4) formulated by the Clinical and Laboratory Standards Institute (CLSI), ensuring the scientific and standardized nature of the experimental method.

[0140] 5. Data processing: SPSS 26.0 statistical software was used to calculate the mean ± standard deviation, and the data were compared synchronously with the previous experimental data of single herbs (diameter of inhibition zone, MIC value) to ensure the reliability and comparability of the results.

[0141] II. Experimental Results The inhibition zones of each test agent are shown in Table 1.

[0142] Table 1. Inhibition zones of each test agent Note: Synergistic antibacterial rate refers only to the synergistic effect between the composition and the corresponding single herb. "-" indicates no synergistic relationship (single herb has no synergistic effect with composition).

[0143] 1. Comparison of inhibition zone diameters (Oxford cup method, cup inner diameter 6mm) Based on the reference values ​​for the inhibition zone of single Chinese herbal medicines, the diameters of the inhibition zones of the two groups of compositions containing and without Polygonum cuspidatum were compared with those of the single herb to clarify the influence of Polygonum cuspidatum on the inhibition zone of the compositions. The core effect of this study is to demonstrate the synergistic effect of the compound and the role of Polygonum cuspidatum. The specific comparison is as follows: 1.1 Antibacterial zones of the two groups of compositions: ① Composition containing Polygonum cuspidatum (external washes prepared in Examples 7 and 8): The diameter of the antibacterial zone in Example 7 was 30-36 mm, and the diameter of the antibacterial zone in Example 8 was 28-34 mm. Both were significantly larger than the diameter of the antibacterial zones of all single-herb water extracts, and the edges of the antibacterial zones were clear and neat, without obvious turbidity, indicating that the composition had excellent antibacterial activity, superior to the individual effects of any single herb. ② Composition without Polygonum cuspidatum (external washes lacking Polygonum cuspidatum): Due to the removal of the core antibacterial component Polygonum cuspidatum (the single herb has an antibacterial zone of 18-22 mm, with strong activity), the synergistic effect was weakened. The diameter of the antibacterial zone was 26-32 mm, still significantly larger than other single herb except Coptis chinensis, but significantly smaller than the composition containing Polygonum cuspidatum (difference of 2-6 mm in Example 6, difference of 2-2 mm in Example 7). The edges of the antibacterial zone were still clear, but some gradients may show slight turbidity, indicating that the absence of Polygonum cuspidatum reduces the antibacterial activity of the composition, but does not affect its overall strong antibacterial properties.

[0144] 1.2 Differences compared with single-herb Chinese herbal water extracts: (1) Comparison with highly active single herb water extracts: Coptis chinensis water extract has the largest inhibition zone (25-30 mm) among single herbs. The inhibition zone of the composition without Polygonum cuspidatum is 1-7 mm higher than that of Coptis chinensis, with an increase of 4.0%-23.3%, which is lower than that of the composition containing Polygonum cuspidatum (Example 6 shows an increase of 0-44.0% compared to Coptis chinensis, and Example 8 shows an increase of 12.0%-13.3% compared to Coptis chinensis). Sophora flavescens water extract is a single herb with strong antibacterial activity (inhibition zone 20-24 mm). The inhibition zone of the composition without Polygonum cuspidatum is 2-12 mm higher than that of Sophora flavescens, with a significant increase, but it is also lower than that of the composition containing Polygonum cuspidatum (Example 7 shows an increase of 25.0%-75.0% compared to Sophora flavescens water extract, and Example 8 shows an increase of 16.7%-41.7% compared to Sophora flavescens water extract). This shows that Polygonum cuspidatum can enhance the synergistic effect of the composition with Coptis chinensis and Sophora flavescens. The synergistic increase is significantly reduced after its absence.

[0145] (2) Compared with aqueous extracts of active single herbs: The diameter of the inhibition zone of aqueous extracts of Stemona japonica, borneol and menthol is at a medium level. The inhibition zone of the composition without Polygonum cuspidatum is 7-17 mm higher than that of Stemona japonica, 8-18 mm higher than that of borneol and 6-16 mm higher than that of menthol, with an increase of 36.8%-89.5%. The increase is lower than that of the composition containing Polygonum cuspidatum (Example 6 shows an increase of 57.9%-100.0% compared with the three, and Example 7 shows an increase of 47.4%-80.0% compared with the three). This indicates that Polygonum cuspidatum can help enhance the synergistic effect of active single herbs. Although the absence of Polygonum cuspidatum can still significantly enhance the antibacterial ability of active single herbs, the increase is greatly reduced.

[0146] (3) Compared with low-activity single herbs: Purslane water extract and Sichuan pepper water extract are herbs with relatively weak antibacterial activity among single herbs. The antibacterial zone of the composition without Polygonum cuspidatum is 10-20 mm and 12-22 mm higher than the two respectively, with an increase of 62.5%-157.1%. The increase is close to that of the composition containing Polygonum cuspidatum (Example 7 increased by 87.5%-157.1% compared with the two, and Example 8 increased by 75.0%-142.9% compared with the two), indicating that Polygonum cuspidatum has little effect on the synergistic auxiliary effect of low-activity single herbs. Even if it is missing, the composition can still effectively make up for the lack of antibacterial activity of low-activity single herbs.

[0147] (4) Comparison with positive drugs: The antibacterial effect of the composition containing Polygonum cuspidatum (Example 7, Example 8) is close to that of Jieeryin solution. The diameter of the inhibition zone in Example 8 is only 2-8 mm different from that in Jieeryin solution, which proves that the composition provided by the present invention has a good antibacterial effect.

[0148] (5) Comparison of compositions with different amounts of Polygonum cuspidatum: The antibacterial zone of the external wash prepared in Example 7 (120 parts of Polygonum cuspidatum) was higher than that of the external wash prepared in Example 8 (80 parts of Polygonum cuspidatum), indicating that within the range of 80 to 120 parts of Polygonum cuspidatum, appropriately increasing the amount of Polygonum cuspidatum can increase the diameter of the antibacterial zone of the composition and enhance the antibacterial effect.

[0149] 1.3 Situation Analysis: ① Compositions containing Polygonum cuspidatum: If the diameter of the inhibition zone in Example 7 did not reach 30 mm and in Example 8 did not reach 28 mm, it is speculated that there was excessive loss of volatile components of borneol and menthol, or that the proportions of the medicinal materials were not reasonable, resulting in insufficient synergistic effect; in this case, the preparation process needs to be optimized and the experiment needs to be re-verified. ② Compositions without Polygonum cuspidatum: If the diameter of the inhibition zone is less than 26 mm, it is speculated that there was insufficient dosage of Coptis chinensis and Sophora flavescens, or that there was excessive loss of borneol and menthol; the proportions of the seven herbs need to be adjusted (appropriately increasing the dosage of Coptis chinensis and Sophora flavescens) or the preparation process needs to be optimized.

[0150] 2. Comparison of MIC values ​​(twofold dilution method in test tubes) Based on the MIC reference values ​​of single Chinese herbal medicines, the MIC values ​​of two groups of compositions (the external washes prepared in Examples 7 and 8 and the external wash lacking Polygonum cuspidatum) were compared with those of the single herb to clarify the effect of Polygonum cuspidatum on the antibacterial concentration of the composition. The core focus is on the effect of the compound on reducing the antibacterial concentration and the synergistic value of Polygonum cuspidatum. The specific comparison is as follows: 2.1 MIC values ​​of the two groups of compositions: ① Composition containing Polygonum cuspidatum (external lotion prepared in Examples 7 and 8): Example 6: MIC value of 0.046875~0.09375 g / mL, MIC50 of 0.046875 g / mL, and MIC90 of 0.09375 g / mL; Example 7: MIC value of 0.0625~0.125 g / mL, MIC50 of 0.0625 g / mL, and MIC90 of 0.125 g / mL. Both are significantly lower than the MIC values ​​of all single Chinese herbal medicines, indicating that the composition can exert antibacterial effect at a lower concentration and has more stable and stronger antibacterial activity. ② Composition without Polygonum cuspidatum (topical wash lacking Polygonum cuspidatum): Due to the lack of synergistic effect of Polygonum cuspidatum, the antibacterial concentration is significantly increased, with MIC values ​​of 0.078125~0.15625 g / mL, MIC50 of 0.078125 g / mL, and MIC90 of 0.15625 g / mL. This is still lower than other single Chinese herbal medicines except Coptis chinensis, but significantly higher than the composition containing Polygonum cuspidatum (difference from Example 6: 0.03125~0.0625 g / mL, and difference from Example 7: 0.015625~0.03125 g / mL). This indicates that Polygonum cuspidatum can reduce the antibacterial concentration of the composition. After its absence, the composition requires a higher concentration to achieve the same antibacterial effect, but the overall antibacterial activity is still better than most single Chinese herbal medicines.

[0151] 2.2 Differences compared with single Chinese herbal medicines (focusing on comparisons with compositions excluding Polygonum cuspidatum): (1) Compared with highly active single herbs: Coptis chinensis water extract has the lowest MIC value (0.0625~0.125g / mL) among single herbs. The MIC value of the composition without Polygonum cuspidatum is slightly higher than that of Coptis chinensis, and the antibacterial concentration is 25.0%~25.0% higher than that of Coptis chinensis water extract (the composition containing Polygonum cuspidatum in Example 7 is 25.0%~50.0% lower than that of Coptis chinensis, and in Example 8 it is the same as that of Coptis chinensis); the MIC50 is 25.0% higher than that of Coptis chinensis water extract (0.0625g / mL), indicating that Polygonum cuspidatum is the key component of the composition that works synergistically with Coptis chinensis to reduce the antibacterial concentration. Without it, the composition cannot reduce or even increase the antibacterial concentration, and the antibacterial effect is weaker than the synergistic effect of Coptis chinensis and Polygonum cuspidatum.

[0152] (2) Compared with active single herbs: the MIC values ​​of Sophora flavescens water extract, borneol and Stemona japonica water extract were 0.125~0.5 g / mL. The MIC value of the composition without Polygonum cuspidatum was 37.5%~84.4% lower than the three. The MIC value of menthol was 0.5~1.0 g / mL. The MIC value of the composition without Polygonum cuspidatum was 68.8%~92.2% lower than that. The increase was lower than that of the composition containing Polygonum cuspidatum (Example 7 was 50.0%~90.6% lower than the four, and Example 8 was 40.0%~87.5% lower than the four). This shows that Polygonum cuspidatum can enhance the synergistic effect of active single herbs and compound, and further reduce the antibacterial concentration. The synergistic concentration reduction effect is significantly weakened after its absence.

[0153] (3) Compared with low-activity single herbs: The MIC values ​​of water extracts of purslane and Sichuan pepper were 1.0~2.0 g / mL. The MIC value of the composition without Polygonum cuspidatum was reduced by 92.2%~96.1% compared with the two. The reduction was close to that of the composition containing Polygonum cuspidatum (93.8%~97.7% reduction in Example 7 and 93.8%~96.9% reduction in Example 8). This indicates that Polygonum cuspidatum has little effect on the concentration reduction synergistic effect of low-activity single herbs. Even without it, the composition can still significantly reduce the antibacterial concentration of low-activity single herbs.

[0154] 3. Quantitative Analysis of Synergistic Effects: ① Compositions containing Polygonum cuspidatum: The synergistic antibacterial rate of Example 7 with each individual herb was 25%~45%, and the synergistic antibacterial rate of Example 8 with each individual herb was 20%~40%. Among them, Coptis chinensis, Sophora flavescens, and Polygonum cuspidatum had the highest synergistic antibacterial rates (40%~45% in Example 7 and 35%~40% in Example 8). ② Compositions without Polygonum cuspidatum (external lotion lacking Polygonum cuspidatum): The synergistic antibacterial rate with each individual herb was 15%~35%. Among them, Coptis chinensis and Sophora flavescens had the highest synergistic antibacterial rates (30%~35%), which were significantly lower than those with Polygonum cuspidatum. The synergistic antibacterial rates of borneol and menthol were 20%~30%, and those of Portulaca oleracea and Zanthoxylum bungeanum were 15%~25%, all lower than those with Polygonum cuspidatum. This indicates that the absence of Polygonum cuspidatum reduces the overall synergistic antibacterial rate of the composition, but still maintains a certain synergistic effect without antagonistic effects.

[0155] The formula for calculating the synergistic antibacterial rate is as follows: .

[0156] 4. Comparison with positive control drugs: The antibacterial effect of the composition containing Polygonum cuspidatum (Examples 7 and 8) is close to that of Jieeryin solution. The difference between the MIC value of Example 8 and Jieeryin solution is only 0.015625~0.03125g / mL, which proves that the composition provided by the present invention has a good antibacterial effect.

[0157] 5. Comparison of compositions with different amounts of Polygonum cuspidatum: The topical lotion prepared in Example 7 (120 parts of Polygonum cuspidatum) has an extremely strong antibacterial activity level, which is higher than the strong antibacterial activity level of the topical lotion prepared in Example 8 (80 parts of Polygonum cuspidatum). Moreover, the inhibition zone of Example 7 is larger and the MIC value is lower, indicating that within the range of 80-120 parts of Polygonum cuspidatum, the ratio of 120 parts of Polygonum cuspidatum has a better antibacterial effect.

[0158] 6. Comparison of antibacterial stability 6.1 Antibacterial stability of single Chinese herbal medicines: Among the single Chinese herbal medicines, Coptis chinensis, Sophora flavescens, and Polygonum cuspidatum showed good antibacterial stability (MIC deviation ≤ 1 gradient in 3 parallel experiments); Borneol and Menthol showed moderate antibacterial stability due to the loss of volatile components (deviation can reach 1~2 gradients); Purslane and Zanthoxylum bungeanum showed weak antibacterial activity and poor stability (deviation can reach 2 gradients), and were greatly affected by extraction process and culture conditions.

[0159] 6.2 Antibacterial stability of the two groups of compositions: ① Composition containing Polygonum cuspidatum (external wash prepared in Examples 7 and 8): The antibacterial stability was significantly better than that of all single Chinese herbal medicines. In the parallel experiments of Example 7, the MIC deviation was ≤1 gradient and the inhibition zone diameter deviation was ≤1mm; in the parallel experiments of Example 8, the MIC deviation was ≤1 gradient and the inhibition zone diameter deviation was ≤1.2mm. The core reason is that the antibacterial components of each single herb synergistically complement each other, compensating for the instability of a single component. ② Composition without Polygonum cuspidatum (external wash lacking Polygonum cuspidatum): The antibacterial stability was slightly lower than that of the composition containing Polygonum cuspidatum, but still better than that of all single Chinese herbal medicines. In the three parallel experiments, the MIC deviation was ≤1 gradient and the inhibition zone diameter deviation was ≤2mm. The core reason is that even without Polygonum cuspidatum, Coptis chinensis and Sophora flavescens can still exert a core synergistic effect, compensating for the instability of volatile and low-activity components. The stability was only slightly reduced, but the overall stability remained reliable.

[0160] 7 Key Conclusions 7.1 Ranking of antibacterial activity (from strongest to weakest): External lotion prepared in Example 7 (120 parts of Polygonum cuspidatum) > External lotion prepared in Example 8 (80 parts of Polygonum cuspidatum) > External lotion without Polygonum cuspidatum > Coptis chinensis > Sophora flavescens > Polygonum cuspidatum > Borneol > Stemona japonica > Menthol > Portulaca oleracea > Zanthoxylum bungeanum; The diameter of the inhibition zone (26~32mm) and the MIC value (0.078125~0.15625g / mL) of the external lotion without Polygonum cuspidatum were better than all the single herbs except Coptis chinensis, but significantly weaker than the compositions of Examples 6 and 7 containing Polygonum cuspidatum, indicating that Polygonum cuspidatum can significantly enhance the antibacterial activity of the composition and is one of the core antibacterial components of the composition.

[0161] 7.2 The role of Polygonum cuspidatum in the composition: Polygonum cuspidatum has a significant synergistic effect with Coptis chinensis and Sophora flavescens, which can further enhance the antibacterial activity of the composition, reduce the antibacterial concentration, enhance the synergistic antibacterial rate, and improve the antibacterial stability of the composition. Polygonum cuspidatum has a weak synergistic effect on low-activity single herbs (purslane, Zanthoxylum bungeanum), and mainly acts on high- and medium-activity single herbs, laying the foundation for the strong antibacterial effect of the composition.

[0162] 7.3 Comparison of the advantages of the two groups of compositions: ① Composition containing Polygonum cuspidatum (topical washes prepared in Examples 7 and 8): stronger antibacterial activity, lower antibacterial concentration, and more significant synergistic effect. Among them, Example 7 (120 parts of Polygonum cuspidatum) has a better antibacterial effect than Example 8 (80 parts of Polygonum cuspidatum), and is more suitable for further research on in vitro anti-Candida albicans and subsequent formulation development. ② Composition without Polygonum cuspidatum (topical washes lacking Polygonum cuspidatum): although the antibacterial activity is slightly weaker, it still has strong antibacterial ability and synergistic effect, and avoids the use of Polygonum cuspidatum. It can be used as an alternative. If there are problems such as high extraction difficulty and high cost of Polygonum cuspidatum in subsequent experiments, the seven-herb composition without Polygonum cuspidatum can be considered.

[0163] 7.4 Synergistic Mechanism: The synergistic mechanism of the composition containing Polygonum cuspidatum (the external lotion prepared in Examples 7 and 8) is related to the synergistic effect of Polygonum cuspidatum glycoside, berberine, and matrine, as well as the increased dissolution rate of the components; the synergistic mechanism of the composition without Polygonum cuspidatum (the external lotion lacking Polygonum cuspidatum) mainly depends on the complementary effect of berberine, matrine, borneol, menthol, and other components.

[0164] Example 10 Animal Model Experiment Source and treatment of Candida albicans: 10 μL of Candida albicans ATCC10231 (provided by Professor Li Yuye of the Department of Dermatology and Venereology, First Affiliated Hospital of Kunming Medical University, with the applicant promising to distribute it for 20 years from the date of application) was taken from -80℃ and spread evenly on SDA medium. It was incubated at 37℃ for approximately 24 hours. Smooth single colonies were collected and streaked with a Z-line in both Kolmargarine chromogenic medium and SDA medium. The cultures were then incubated at 37℃ for 48 hours. The Kolmargarine chromogenic medium was observed. SDA culture was passaged three times for further analysis.

[0165] The steps for constructing a mouse model of Candida albicans vaginitis are as follows: Figures 10-12 As shown, the specific steps are as follows: After 7 days of acclimatization feeding, vaginal irrigation fluid was collected from mice, and 10 μL of the diluted solution was applied to SDA medium for 24 hours to observe for the growth of Candida albicans.

[0166] Pretreatment: Four days before inoculation, mice were subcutaneously injected with estradiol valerate (E2, 0.5 mg / mL) at a dose of 0.025 mL per day to dilate the vagina of mice, increase estrogen levels, and facilitate the colonization of Candida albicans. Inoculation for each group: The mice were divided into a blank group, a model group, a fluconazole group, a Fuyanjie group, a high-dose traditional Chinese medicine group, and a medium-dose traditional Chinese medicine group. An appropriate amount of Candida albicans was added to PBS to prepare a bacterial suspension of 1.5×10 6 CFU / mL. 20 μL of the suspension was aspirated with a pipette and injected into the vaginas of mice in the model group, fluconazole group, Fuyanjie group, high-dose traditional Chinese medicine group, and medium-dose traditional Chinese medicine group, and left for 5 min to prevent liquid overflow. The blank group of mice was injected with PBS. On the second day after inoculation, 3 mice were randomly selected from each group and their vaginas were lavaged with PBS, and the obtained lavage fluid was cultured to determine whether the model was successful. After inoculation, mice were subcutaneously injected with E2 every two days. Finally, a murine model of Candida albicans vaginitis was established. Colony counting of Candida albicans in the vagina: The vaginas of mice were lavaged with PBS buffer, and 10 μL of the lavage fluid (lavage fluid:PBS buffer = 1:5) was evenly spread on SDA medium and incubated at 37 °C for 24 h - 48 h, and then the number of colonies was counted. The remaining lavage fluid was stored at -80 °C for future use.

[0167] The successfully established murine model of Candida albicans vaginitis was grouped into a model group, a fluconazole group, a Fuyanjie group, a high-dose traditional Chinese medicine group, and a medium-dose traditional Chinese medicine group, and normal mice were used as the blank group. There were 10 mice in each treatment group, and each treatment was repeated 10 times. The specific treatments for different groups were as follows: Blank group: PBS buffer, 2.5 mL / kg; Model group: PBS buffer, 2.5 mL / kg Fluconazole group: Fluconazole dispersible tablets, 5 mL / kg; Fuyanjie group (batch number 2024061502 12): Fuyanjie lotion (the main components are Sophora flavescens, Stemona japonica, Cnidium monnieri, Phellodendron amurense, and Borneol), 2.5 mL / kg; <00​​​​​​​​​​​​On day 29 of the experiment, ELISA was performed on vaginal lavage fluid from mice under different treatments, and the results are as follows: Figure 15 and Figure 16 As shown in the figure. The results showed that compared with the model group, the high- and medium-dose traditional Chinese medicine groups and the fluconazole group had a more significant reduction in IL-6 levels than the Fuyanjie group; among the various traditional Chinese medicine dosage groups, the high-dose group had the most significant reduction in IL-6 levels. Compared with the model group, the high- and medium-dose traditional Chinese medicine groups and the fluconazole group had a more significant reduction in IL-8 levels than the Fuyanjie group. Among the various traditional Chinese medicine dosage groups, the high-dose group had the most significant reduction in IL-8 levels. Therefore, the traditional Chinese medicine composition (Polygonum cuspidatum, Coptis chinensis, Stemona japonica, Zanthoxylum bungeanum, menthol, and borneol) provided by this invention has a better relieving effect than the commercially available product Fuyanjie (Sophora flavescens, Stemona japonica, Cnidium monnieri, Phellodendron amurense, and borneol). This is because this invention creatively uses Polygonum cuspidatum and Zanthoxylum bungeanum, optimizing the relationship between the principal, assistant, and adjuvant herbs, ultimately achieving a better therapeutic effect. Moreover, the Coptis chinensis used in this invention is cheaper than Phellodendron amurense, achieving better results at a lower cost.

[0170] During the 7 days of treatment, the weight trends of mice in each treatment group were as follows: Figure 17 As shown in the figure. The results showed that the body weight of mice in all treatment groups decreased. Comparing the different dosage groups of traditional Chinese medicine, the high-dose group showed the most gradual decrease in body weight. Therefore, it can be seen that the traditional Chinese medicine composition provided in this application has a relatively small impact on mice at high doses.

[0171] During the 7 days of treatment, the bacterial load in mice in each treatment group was as follows: Figure 18 As shown, the vaginal irrigation solution was smeared onto the plate. Figure 19 As shown in the figure. The results showed that during the 7 days of treatment, the number of Candida albicans colonizing the vagina was reduced in each treatment group compared to the model group. Compared to the Fuyanjie group, the high-dose group showed a reduction in the number of Candida albicans colonizing the vagina on days 1 and 3 of treatment. Comparing the various Chinese medicine dosage groups, the high-dose group showed a significant reduction in the number of Candida albicans colonizing the vagina. In the early stages of treatment (days 1-3), the Chinese medicine group was able to rapidly reduce the pathogenic bacterial load, while the Fuyanjie group had a relatively slow antibacterial effect, indicating that the composition provided by this invention has a superior antibacterial speed and intensity. It can be seen that the antibacterial effect of the Chinese medicine composition provided by this invention is also superior to that of the commercially available product Fuyanjie. The reason for this is that the composition provided by this invention optimizes the principal, assistant, adjuvant, and guide relationships and creatively uses two Chinese herbs, Polygonum cuspidatum and Zanthoxylum bungeanum.

[0172] Simultaneously, vaginal tissue samples from mice (Control group, Model group, and high-dose traditional Chinese medicine group H) were sent to the company for differential gene function analysis: PCA ( Figure 20Analysis showed that after inducing VVC, the gene levels of mice were affected, showing significant differences compared with the normal group, and the drug group also affected the gene expression of mice. Further analysis of the differentially expressed genes among groups was carried out with Padjust < 0.05 and the up- or down-regulation fold change of 2 as the screening criteria for differentially expressed genes. The results showed that compared with the Control group, 921 genes were significantly up-regulated and 559 genes were significantly down-regulated in the Model group; compared with the Model group, 156 genes were significantly up-regulated and 14 genes were significantly down-regulated in the H group after the intervention of the traditional Chinese medicine compound ( Figures 21-23 ). Thus, it can be seen that the traditional Chinese medicine compound affects gene expression, specifically manifested as: Compared with the Control group, 921 genes were significantly up-regulated and 559 genes were significantly down-regulated in the Model group; Compared with the Model group, 156 genes were significantly up-regulated and 14 genes were significantly down-regulated in the H high-dose traditional Chinese medicine group after the intervention of the traditional Chinese medicine compound.

[0173] In summary, the high-dose traditional Chinese medicine group has a relieving effect on murine vulvovaginal candidiasis. Moreover, the relieving effect of the high-dose group is better than that of Fuyanjie and the medium-dose traditional Chinese medicine group. The traditional Chinese medicine composition and drug provided by the present invention can effectively relieve simple vaginitis.

[0174] The embodiments described above are only descriptions of the preferred embodiments of the present invention, and do not limit the scope of the present invention. Without departing from the design spirit of the present invention, various modifications and improvements made by those of ordinary skill in the art to the technical solutions of the present invention shall fall within the protection scope determined by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: 80-120 parts of Polygonum cuspidatum, 80-120 parts of Coptis chinensis, 80-120 parts of Sophora flavescens, 30-70 parts of Portulaca oleracea, 20-40 parts of Stemona japonica, 10-20 parts of Zanthoxylum bungeanum, 3-7 parts of borneol and 3-7 parts of menthol.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: 120 parts Polygonum cuspidatum, 120 parts Coptis chinensis, 80 parts Sophora flavescens, 30 parts Portulaca oleracea, 20 parts Stemona japonica, 10 parts Zanthoxylum bungeanum, 3 parts Borneol, and 3 parts Menthol; or, The traditional Chinese medicine composition comprises the following components in parts by weight: 80 parts of Polygonum cuspidatum, 80 parts of Coptis chinensis, 120 parts of Sophora flavescens, 70 parts of Portulaca oleracea, 40 parts of Stemona japonica, 20 parts of Zanthoxylum bungeanum, 7 parts of borneol and 7 parts of menthol.

3. The use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating acute eczema or simple vaginitis.

4. A medicament for treating acute eczema or simple vaginitis, characterized by, The raw materials for preparing the drug include the traditional Chinese medicine composition as described in claim 1 or 2.

5. The drug according to claim 4, characterized in that, The drug also includes pharmaceutically acceptable excipients.

6. The drug according to claim 4, characterized in that, The dosage forms of the drug include topical liquid preparations, topical cream preparations, and topical suppositories.

7. A method for preparing the drug according to any one of claims 4-6, characterized in that, Includes the following steps: (1) Dry the Polygonum cuspidatum, Coptis chinensis, Sophora flavescens, Portulaca oleracea, Stemona japonica and Zanthoxylum bungeanum, then grind them into powder and mix them to obtain a mixed coarse powder; grind the borneol and menthol into fine powder separately for later use; (2) Add pure water to the mixed coarse powder for extraction, collect the extract, concentrate it to obtain the original Chinese medicine liquid, and cool it for later use; (3) Add borneol powder and menthol powder to the cooled Chinese herbal medicine liquid, mix well, and obtain the medicine; Alternatively, it may include the following steps: (S1) The Polygonum cuspidatum, Coptis chinensis, Sophora flavescens, Portulaca oleracea, Stemona japonica and Zanthoxylum bungeanum are sequentially soaked, decocted, decocted and concentrated to obtain an extract; (S2) The extract, menthol and borneol are mixed to obtain the drug.

8. The preparation method according to claim 7, characterized in that, In step (2), the specific extraction steps include: adding 9-10 times the weight of pure water to the mixed coarse powder, soaking for 0.5-1.5 hours, reflux extraction for 1.5-2.5 hours, and filtering; adding 7-9 times the weight of pure water to the filter residue, reflux extraction for 1.5-2.5 hours, and filtering; combining the two filtrates to obtain the extract; concentrating the extract under reduced pressure to 1 / 5-1 / 4 of its original volume to obtain the original Chinese medicine liquid.

9. The preparation method according to claim 7, characterized in that, In step (S1), when performing the soaking treatment, the amount of water used is 3 to 5 times the total weight of the Polygonum cuspidatum, Coptis chinensis, Sophora flavescens, Portulaca oleracea, Stemona japonica, and Zanthoxylum bungeanum; the soaking conditions are: soaking at room temperature for 30 to 60 minutes. And / or, the conditions for the first decoction treatment are: boil for 30 to 45 minutes; And / or, when performing the second decoction treatment, the amount of water used is 3 to 5 times the weight of the dregs obtained from the first decoction treatment; the conditions for the second decoction treatment are: boil and then maintain for 20 to 30 minutes. And / or, the concentration process is a vacuum concentration process; the concentration process conditions are: 60~70℃, -0.08~-0.06MPa, concentrated to a relative density of 1.10~1.

20.

10. The preparation method according to claim 7, characterized in that, When the dosage form of the drug is a topical liquid preparation, the extract, menthol, and borneol are mixed, and then a preservative and a moisturizer are added to obtain the topical liquid preparation; when the dosage form of the drug is a topical suppository, the steps of drying and adding a matrix are further included before mixing the extract, menthol, and borneol. And / or, the matrix comprises semi-synthetic fatty acid glycerides.

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