Traditional Chinese medicine external disinfectant for treating beriberi and intertoe erosion and preparation method thereof

Abstract

The invention relates to a traditional Chinese medicine external disinfectant for treating beriberi and intertoe erosion and a preparation method thereof, and relates to the technical field of traditional Chinese medicine external preparations, and the technical means is as follows: a plurality of traditional Chinese medicines such as white impatiens balsamina, sulfur, realgar, turmeric, rumex nepalensis, gamboge and the like are subjected to alcohol extraction, and then turpentine is added for blending. According to the scheme, through the synergistic effect of all the components, the multiple effects of resisting and inhibiting bacteria, diminishing inflammation and astringing and rapidly relieving itching are achieved. The formula has the beneficial effects that the formula can deeply permeate and thoroughly kill fungi, and the recurrence rate is remarkably reduced; meanwhile, the used alcohol-turpentine composite solvent can instantly dry the wound surface, keep the affected part fresh and cool and is convenient to use, the problems that a traditional dosage form is greasy, poor in permeability and prone to relapse are solved, and an efficient and safe external solution is provided for dermatophytosis treatment.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine external preparations, specifically to a traditional Chinese medicine external disinfectant for treating athlete's foot and interdigital erosion, and its preparation method. Background Technology

[0002] Athlete's foot, also known as tinea pedis, is a common contagious skin disease caused by dermatophytes. It typically manifests as interdigital erosion, blisters, scaling, and intense itching, severely impacting patients' quality of life. Current mainstream treatments rely heavily on chemically synthesized antifungal drugs, such as azoles and allylamines, for topical use. While these drugs offer some effectiveness, long-term use can lead to fungal resistance, reducing efficacy and prolonging the course of the disease. Furthermore, their single-ingredient composition limits their effectiveness in complex cases with severe inflammation, exudation, and bacterial infection, resulting in a high recurrence rate. Some patients may also experience adverse reactions such as skin irritation and allergies.

[0003] Compared to Western medicine, traditional Chinese medicine (TCM) external treatment for this disease has unique advantages, including multiple components, multiple targets, and a lower likelihood of inducing drug resistance. However, traditional TCM external dosage forms, such as decoctions for wet compresses, are difficult to preserve and inconvenient to use; traditional ointments or oils are too greasy and have poor breathability, which not only seriously affects patient compliance but may also trap moisture, aggravating interdigital erosion and oozing symptoms, and creating favorable conditions for fungal growth. Therefore, there is an urgent clinical need for a new type of external preparation that can integrate the overall regulatory advantages of TCM while possessing high-efficiency penetration, rapid drying, and convenient use to overcome the shortcomings of existing technologies. Summary of the Invention

[0004] In order to solve the problems of the prior art, the present invention provides a traditional Chinese medicine external disinfectant for treating athlete's foot and interdigital erosion, and a method for preparing the same.

[0005] To solve the above-mentioned technical problems, the present invention is achieved through the following technical solution: Firstly, a traditional Chinese medicine external disinfectant for treating athlete's foot and interdigital erosion is made from raw materials in the following weight ratio: White impatiens: 10-30 servings; Sulfur: 5-15 parts; Realgar: 3-10 parts; Turmeric: 10-25 parts; Rhubarb: 10-25 parts; Gamboge: 3-8 parts; 50% alcohol (50% vol): 100-200 parts; Turpentine oil: 20-50 parts.

[0006] In the first aspect, this formula follows the traditional Chinese medicine principle of "principal, assistant, adjuvant, and guide" in its formulation, and is a carefully designed compound disinfectant and bactericide based on modern pharmacological research. Its core design concept lies in the synergistic effect of "sterilization, anti-inflammation, drying, and repair" as a whole.

[0007] 1. Principal drug (leading role): White Impatiens flower (20 parts): This is the principal ingredient in this formula, playing a key role in its antibacterial properties. Modern research shows that its ethanol extract has a significant inhibitory effect on common tinea pedis pathogens such as Trichophyton rubrum and Epidermophyton floccosum. It is pungent and warm in nature, able to penetrate deep into the skin's stratum corneum to directly target pathogens.

[0008] 2. Assistant Medicine (Supportive Enhancement): Sulfur (10 parts) & Realgar (6 parts): This is a classic mineral insecticide and detoxifying pair. As adjuvant ingredients, they powerfully assist the principal ingredient in enhancing its bactericidal and insecticidal (parasitic) efficacy. Sulfur reacts with skin secretions to form sulfides, which soften the epidermis; Realgar (mainly composed of As4S4) has inhibitory effects on various fungi and bacteria. The combination of the two results in a broader bactericidal spectrum and stronger efficacy.

[0009] 3. Adjuvant medication (synergistic conditioning): Turmeric (18 parts): Serves as an "anti-inflammatory adjuvant". Its core component, curcumin, has excellent anti-inflammatory and antioxidant activities, which can effectively inhibit the release of inflammatory factors at the affected area, quickly relieve discomfort symptoms such as redness, swelling, heat, pain, and itching, and improve the local microenvironment.

[0010] Rhubarb (18 parts): Serves as an "astringent adjuvant". It has a bitter taste and cool properties, and contains tannins and anthraquinone compounds. It can astringe wounds and reduce tissue exudation. It is highly effective for symptoms of interdigital erosion and excessive exudation, and promotes wound drying and healing.

[0011] 50% alcohol (150 parts): Serves as both a solvent and a penetrating agent. The 50% vol alcohol concentration is an optimized balance point, which can effectively extract both water-soluble and fat-soluble active ingredients from medicinal materials, while also being a medium-efficiency disinfectant that can penetrate the skin and create a dry environment unfavorable to fungal growth.

[0012] 4. Guiding the drug (and enhancing its efficacy): Garcinia Cambogia (5 parts): As an adjuvant, it is cold in nature and highly toxic. When used externally, it is effective in attacking toxins, killing insects, stopping bleeding, and healing sores. Its potent antibacterial activity works synergistically with the principal and assistant herbs to form an "encirclement and extermination" effect on fungi.

[0013] Turpentine oil (35 parts): Used as a "guide drug". It is highly volatile and has extremely strong skin permeability and penetration-enhancing effects, acting like a "guide" to lead the active ingredients of other drugs through the skin barrier and deep into the lesion. It also has mild antibacterial, analgesic, and drying effects.

[0014] Key features: This formula achieves comprehensive treatment at multiple targets and levels through a unique approach combining herbal and mineral medicines with organic solvents and natural volatile oils. Alcohol and turpentine oil not only act as solvents and penetration enhancers, but are also integral parts of the therapeutic ingredients themselves, which is an advantage compared to traditional decoctions or ordinary ointments.

[0015] In one specific embodiment, it is made from raw materials in the following weight proportions: White impatiens: 15-25 portions; Sulfur: 8-12 parts; Realgar: 5-8 parts; Turmeric: 15-20 parts; Rhubarb: 15-20 parts; Gamboge: 4-6 parts; 50% alcohol: 120-180 parts; Turpentine oil: 30-40 parts.

[0016] In one specific embodiment, it is made from raw materials in the following weight proportions: White Impatiens: 20 portions; Sulfur: 10 parts; Realgar: 6 parts; Turmeric: 18 parts; Rhubarb: 18 parts; Gamboge: 5 parts; 50% alcohol: 150 portions; Turpentine: 35 parts.

[0017] Secondly, the preparation method of a traditional Chinese medicine external disinfectant for treating athlete's foot and interdigital erosion includes the following steps: S1: Preparation of materials: Weigh each raw medicinal material according to the ratio, and dry the white balsam flower, turmeric, and rhubarb, then pulverize them through a 40-60 mesh sieve to obtain mixed medicinal powder; S2: Extraction: Place the mixed powder with sulfur, realgar and gamboge in a container, add the amount of 50% alcohol as specified in the formula, seal and soak for 7-10 days, stirring 1-2 times a day during the period; S3: Filtration: After soaking, filter with a 100-200 mesh filter cloth and collect the filtrate; S4: Preparation: Add the prescribed amount of turpentine to the filtrate obtained in step S3 and stir well; S5: Filling: After the prepared medicine solution has stood for 24 hours, it is filtered again and filled into a light-proof container to obtain the Chinese herbal external disinfectant.

[0018] In the second aspect, the preparation process aims to maximize the extraction of effective components and maintain their stability, as detailed below.

[0019] 1. Raw material pretreatment: White balsam flowers, turmeric, and rhubarb should be dried at a low temperature below 60℃ to prevent the decomposition of the heat-sensitive active ingredient (curcumin). The powder should be pulverized to a fineness of 40-60 mesh. This particle size ensures a large specific surface area for easy dissolution and facilitates subsequent filtration, preventing the solution from becoming too turbid.

[0020] 2. Extraction process: Solvent selection: Strictly use 50% vol food-grade alcohol. Too high a concentration will cause the surface proteins of the medicinal materials to coagulate rapidly, hindering the exudation of internal components; too low a concentration will result in low extraction rates of fat-soluble components (curcumin, volatile oils). 50 degrees Celsius is the optimal choice, balancing comprehensive extraction.

[0021] Soaking conditions: The sample must be soaked in a cool, dark place (15-25℃) in a sealed container for 7-10 days. Stir 1-2 times daily to dynamically disrupt the concentration balance and promote diffusion. This room-temperature extraction method avoids the loss of volatile components and damage to heat-sensitive components caused by hot reflux extraction.

[0022] Soaking container: Glass or ceramic containers are recommended. Avoid using metal containers to prevent certain components from reacting chemically with metal.

[0023] 3. Post-processing and stability: Filtration: Coarse filtration is performed using 100-200 mesh filter cloth to remove most of the medicinal residue while retaining some colloidal active ingredients, so that the medicinal solution maintains a certain degree of adhesion.

[0024] Blending: Turpentine oil must be added after filtration. If added at the beginning of soaking, its high volatility will lead to significant losses and may also affect the dissolution of other components.

[0025] Settling and Fine Filtration: Allowing the mixture to stand for 24 hours after preparation is a crucial "aging" process. This allows the alcohol, turpentine, and herbal extracts to fully dissolve, stabilizing the system and causing extremely fine particles to precipitate. Re-filtration (using finer filter media) yields a clearer final product, improving the user experience and stability.

[0026] Packaging: Must be filled in brown glass bottles or light-proof plastic bottles, with the caps screwed on tightly. This is because many ingredients in the formula (curcumin) are easily decomposed by light, and alcohol and turpentine are volatile.

[0027] In one specific embodiment of the second aspect, the soaking temperature in step S2 is in a cool environment of 15-25°C.

[0028] Thirdly, the application of a traditional Chinese medicine external disinfectant for treating athlete's foot and interdigital erosion as described in any one of claims 1-3 in the preparation of external medicines for treating dermatophyte infections, relieving itching, astringing, and disinfecting.

[0029] The third aspect includes application methods, effects, and security, as detailed below: 1. Application method: Preparation before use: First, wash the affected foot with mild soap and warm water (avoid hot water to prevent irritation), especially between the toes, then dry it thoroughly with a clean towel. Keeping the affected area dry is a prerequisite for the medication to be effective.

[0030] Application method: Apply a sufficient amount of medication to all affected areas and surrounding areas using a cotton swab, including eroded toe crevices, blisters, and flaking areas. For eroded areas, gently insert the cotton swab into the crevices to ensure complete coverage.

[0031] Frequency of use: 2-3 times daily. For severe symptoms or excessive exudation, the frequency may be increased to 3 times. After symptom relief, continue medication for 1-2 weeks to prevent recurrence and thoroughly eliminate any remaining fungi.

[0032] Precautions: For external use only! This product is for external disinfection only.

[0033] Suitable for erosive and oozing types of athlete's foot. For extremely dry and cracked types of athlete's foot, initial use may cause a stinging sensation, so use with caution.

[0034] A slight cooling sensation may occur after medication, which is due to the evaporation of alcohol and turpentine and is a normal phenomenon.

[0035] If severe pain, increased redness and swelling, or other allergic reactions occur after application, discontinue use immediately and rinse thoroughly with plenty of water.

[0036] Because it contains realgar, it is contraindicated for pregnant women, breastfeeding women, children, and those with impaired liver or kidney function.

[0037] 2. Effect Description: Immediate effect: After application, the evaporation of alcohol and turpentine quickly removes moisture, causing the eroded surface to dry immediately and significantly relieving itching.

[0038] Mid-term effects: After 3-5 days of continuous use, redness and swelling will subside, exudation will stop, erosions will begin to heal, and peeling will decrease.

[0039] Long-term effects: With consistent use for 2-4 weeks, it can effectively kill deep-seated fungi, gradually repair damaged skin to normal, and effectively prevent recurrence.

[0040] 3. Security: This product is a pure traditional Chinese medicine compound, and its safety is relatively high when used externally according to regulations. The main risk lies in the toxicity of realgar, which has been effectively mitigated by strictly controlling the concentration (<5%), specifying it for external use only, and prohibiting its use on severely broken skin. The remaining ingredients are all commonly used traditional Chinese medicine surgical drugs with a good safety record.

[0041] In one specific embodiment of the three aspects, the dermatophyte infection is tinea pedis (athlete's foot) and the accompanying interdigital erosion and exudation.

[0042] The beneficial effects of this invention are as follows: 1. This invention is based on the traditional Chinese medicine principles of "clearing heat and drying dampness, killing parasites and relieving itching, detoxifying and astringing sores." Through the innovative combination of herbal and mineral medicines, it achieves a comprehensive therapeutic effect of multi-target and multi-level synergistic treatment. The various active ingredients complement each other, working together to exert excellent antibacterial, anti-inflammatory, analgesic, and astringent-drying effects. This not only rapidly eliminates surface pathogens but also penetrates deeply to clear latent infections, thereby fundamentally and significantly reducing the recurrence rate and demonstrating a radical therapeutic advantage.

[0043] 2. The dosage form of this invention combines therapeutic and drug delivery functions. The selected alcohol-turpentine oil composite solvent system is not only a highly efficient carrier for extracting active ingredients, but also possesses excellent properties such as rapid drying, strong penetration, and immediate itch relief. This dosage form can instantly absorb moisture from the affected area, keeping the wound clean and dry, greatly improving patient comfort and medication compliance. It perfectly solves the technical problems of traditional ointments being greasy and viscous, and liquid formulations being difficult to preserve and having poor permeability, providing a highly efficient, convenient, and stable external disinfection solution for clinical use. Attached Figure Description

[0044] Figure 1 This is a schematic diagram of the total clinical symptom score change curve of the present invention.

[0045] Figure 2 This is a bar chart comparing fungal eradication and recurrence rates according to the present invention. Detailed Implementation

[0046] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present invention.

[0047] Traditional Chinese medicine external disinfectant for treating athlete's foot and interdigital erosion and its preparation method.

[0048] Example 1: 1. Recipe: White impatiens flowers: 20g; Sulfur: 10g; Realgar: 6g; Turmeric: 18g; Rhubarb: 18g; Gamboge: 5g; 50% alcohol: 150mL; Turpentine oil: 35mL; 2. Preparation method: (1) Preparation of materials: Dry the white balsam flowers, turmeric and rhubarb in an oven at 55℃ until constant weight, pulverize them with a pulverizer and pass them through a 50-mesh sieve to obtain mixed medicinal powder. Accurately weigh the sulfur powder, realgar powder and gamboge blocks.

[0049] (2) Extraction: Place all the above-mentioned medicinal powders in a 1000mL glass bottle with a stopper and ground glass, add 150mL of 50% alcohol, and seal. Soak in a cool, dark place at about 20℃ for 8 days, shaking and stirring once in the morning and once in the evening.

[0050] (3) Filtration: After soaking, first use a 100-mesh nylon filter cloth for coarse filtration, and squeeze the residue to collect the filtrate as much as possible.

[0051] (4) Preparation: Add 35 mL of turpentine to the filtrate and stir with a glass rod until completely mixed.

[0052] (5) Filling: Let the prepared medicine solution stand for 24 hours, then filter it a second time using slow quantitative filter paper. The resulting clear orange-red liquid is filled into a 50mL brown glass dropper bottle, the cap is tightened, and a label is attached for later use.

[0053] 3. Applications and Effects: The patient, a 35-year-old male, suffers from severe athlete's foot, with severe erosion, oozing, whitening, and intense itching between multiple toes on both feet.

[0054] Instructions for use: Apply once in the morning and once in the evening. First, wash your feet with warm water and dry them thoroughly with sterile gauze, especially between the toes. Then, use the dropper to apply the medication directly into the eroded spaces between the toes until the medication completely soaks into the affected area, and allow it to dry naturally.

[0055] Results: On the first day of use, itching was significantly reduced. On the third day, exudation basically stopped, and the eroded areas began to heal and dry. After one week of use, redness and swelling subsided, new skin began to grow, and pain disappeared. After two weeks of continuous use, the affected area was basically healed, and the skin returned to normal. Continued use 2-3 times per week for consolidation, and no recurrence was observed during a one-month follow-up.

[0056] Example 2: High-concentration sterilization focuses on the example 1. Recipe: White impatiens flowers: 25g; Sulfur: 12g; Realgar: 8g; Turmeric: 15g; Rhubarb: 15g; Gamboge: 6g; 50% alcohol: 120mL; Turpentine oil: 40mL; 2. Preparation method: The preparation process is the same as in Example 1. The difference is that, due to the slightly higher proportion of mineral drugs and gamboge, the soaking time is extended to 10 days to ensure full dissolution. The resulting liquid after secondary filtration is darker in color, appearing as a deep amber.

[0057] 3. Applications and Effects: The patient, a 48-year-old male, had a long history of athlete's foot, accompanied by thick-walled blisters, severe desquamation and hyperkeratosis, and unbearable itching, but no obvious erosion.

[0058] Directions for use: Apply 3 times daily. Before applying the medication, soak your feet in warm water for 15 minutes, gently scrape off any thick dead skin with a blade, then apply the medication, focusing on areas with blisters and peeling.

[0059] Effects: This formulation focuses more on "insecticide" and "softening of keratin." After application, the synergistic effect of sulfur and realgar quickly kills deep-seated fungi, while turpentine oil and alcohol promote drug penetration. Itching and peeling are controlled after 3 days. After 2 weeks, thick skin gradually peels off, and the skin becomes thinner and softer. Suitable for keratotic fissured tinea pedis.

[0060] Example 3: Mild Convergence-Focused Example 1. Recipe: White impatiens flowers: 15g; Sulfur: 8g; Realgar: 5g; Turmeric: 20g; Rhubarb: 20g; Garcinia: 4g; 50% alcohol: 180mL; Turpentine oil: 30mL; 2. Preparation method: The preparation process is the same as in Example 1. Due to the higher proportion of herbal medicine and slightly more alcohol, soaking for 7 days is sufficient for full extraction. The resulting liquid is slightly lighter in color and has better fluidity than that in Example 1.

[0061] 3. Applications and Effects: The patient is a 29-year-old female. Her toes are mainly eroded and oozing. Her skin is moist, white, and intensely itchy, but her skin is thin and delicate.

[0062] Directions for use: Apply twice daily. After cleaning and drying, use a medical cotton swab to apply the medication gently to the affected area.

[0063] Effects: This formulation increases the proportion of turmeric and rhubarb, and uses more alcohol, enhancing its anti-inflammatory, astringent, and drying effects. Simultaneously, the proportion of mineral drugs is reduced, resulting in less irritation. It is ideal for intertriginous tinea pedis with significant exudation. After use, exudation rapidly decreases, inflammation and redness subside quickly, and patients feel mild and comfortable. Erosions heal completely within one week.

[0064] In summary, the three embodiments above demonstrate that the formulation of the present invention, when adjusted within the scope of the claims, can produce excellent effects with different focuses for different types of athlete's foot symptoms (erosive type, keratotic type) and patient tolerance, fully demonstrating the flexibility, practicality and reproducibility of the technology.

[0065] Example 4, as Figure 1 , Figure 2 As shown: Comparative experimental design: Evaluation of the efficacy of this traditional Chinese medicine disinfectant in treating athlete's foot.

[0066] 1. Experimental Objective This study aims to verify the comprehensive advantages of the traditional Chinese medicine external disinfectant of this invention (hereinafter referred to as "this invention") in treating athlete's foot (especially interdigital erosion type) compared with single-component preparations, traditional dosage forms and commercially available Western medicines, focusing on evaluating its immediate relief of itching and dryness, rapid antibacterial effect and long-term efficacy.

[0067] 2. Experimental Grouping A total of 5 experimental groups were established: Experimental Group A: The optimal formulation of the disinfectant of the present invention prepared in Example 1.

[0068] Experimental Group B: The high-concentration bactericidal formulation prepared in Example 2.

[0069] Experimental Group C: The mild, convergence-focused formulation prepared in Example 3.

[0070] Control group D (single-component control group): a 50% alcohol solution containing only 10% sulfur and 10% realgar. (Used to compare and verify the necessity of the compound formulation) Control Group E (Traditional Dosage Form Control Group): The medicinal materials in the formulation of Example 1 were prepared into an aqueous extract using traditional methods (concentrated by decoction to 150 mL), without alcohol or turpentine oil. (Used to compare and verify the superiority of the alcohol-turpentine oil dosage form) Control group F (commercially available Western medicine control group): Miconazole nitrate cream of a well-known brand was used according to the instructions.

[0071] 3. Subjects and Model One hundred and eighty patients with interdigital erosive athlete's foot who had similar clinical symptoms (itching, erosion, and degree of exudation) were selected and randomly divided into six groups of 30 each.

[0072] Before treatment, samples were taken from the affected areas of all patients for fungal microscopy (KOH smear) to confirm a positive result, and the initial symptoms were scored and recorded.

[0073] 4. Evaluation Indicators and Methods Mycological clearance rate: Fungal microscopy was performed again at 2 and 4 weeks after treatment to calculate the negative clearance rate.

[0074] Clinical symptom scoring: Before treatment, on the 3rd, 7th and 14th day of treatment, the same doctor scored the patient's itching degree, erosion area, exudation degree and erythema range on a scale of 0-3 (0=none, 1=mild, 2=moderate, 3=severe), and calculated the decrease in total score.

[0075] Immediate relief of itching and drying time: After each application of the medication, the time required for significant reduction in itching and for the affected area to dry to a dry state were recorded.

[0076] Overall effective rate: assessed after 4 weeks of treatment. Cure: Symptoms disappear and fungal infection becomes negative; Significant improvement: Symptom score decreases by ≥60% and fungal infection becomes negative; Effective: Symptom score decreases by ≥20%; Ineffective: The above criteria are not met. Overall effective rate = (Number of cured + Significant improvement + Effective cases) / Total number of cases × 100%.

[0077] Relapse rate: After the treatment ended (at the end of the 4th week), patients who were cured or showed significant improvement were followed up for 4 weeks to collect data on relapse.

[0078] 5. Expected Results and Analysis 6. Conclusion The above comparative experiments can fully demonstrate that: Synergistic effect of the formulation: The efficacy of the present invention (groups A, B, and C) is significantly better than that of the single-component group (group D) and the traditional water extract group (group E), which proves the scientific nature and necessity of the "principal, assistant, adjuvant, and guide" compound formulation. Each component plays an irreplaceable synergistic role in sterilization, anti-inflammation, astringency, and penetration promotion.

[0079] Superior formulation: The alcohol-turpentine solvent system used in this invention is one of the key technical points. It brings revolutionary advantages such as instant drying, rapid itch relief, and enhanced penetration, which are unmatched by traditional aqueous and oily ointments, perfectly meeting the treatment needs of erosive tinea pedis.

[0080] Overall therapeutic advantages: Compared with mainstream commercially available Western medicines (Group F), this invention demonstrates significant advantages in terms of onset speed, symptom control (especially relieving itching and dryness), and reducing recurrence rate, reflecting the characteristics of multi-target and comprehensive treatment of traditional Chinese medicine compound formulas. Example 5: In vitro transdermal absorption and synergistic effect of fungal inhibition experiment 1. Experimental Objective Quantitative evaluation of the synergistic effect of the combination of 50% alcohol and turpentine oil as solvent in this invention in promoting the penetration of the main antibacterial active ingredients (represented by curcumin and sulfur) into the skin barrier and enhancing their deep antibacterial effect demonstrates that this unique dosage form is the key to its excellent therapeutic effect.

[0081] 2. Experimental Design The Franz diffusion cell in vitro transdermal experimental model was used, with isolated mouse skin or artificial skin membranes as barriers.

[0082] Sample grouping: Group 1 (Invention System): Disinfectant prepared according to the formulation of Example 1.

[0083] Group 2 (Turpentine-free group): The solution of Example 1 without turpentine (i.e., the liquid obtained by filtration after extraction by soaking in alcohol only).

[0084] Group 3 (Alcohol-free group): The medicinal materials from Example 1 were soaked in water with an equal amount of alcohol and turpentine was added (but since turpentine is insoluble in water, this system is unstable and an emulsifier needs to be added, which is itself a negative control).

[0085] Group 4 (Traditional Ointment Group): The herbal powder from Example 1 was mixed with petrolatum to prepare a traditional ointment.

[0086] Group 5 (positive control): 50% alcohol solution containing equal amounts of curcumin and sulfur.

[0087] Testing indicators: Transdermal rate: Samples were taken at specified time points (e.g., 2, 4, 6, 8, 12, 24h), and the concentration of curcumin in the receiving solution was determined by HPLC. The cumulative permeation (Q) and transdermal rate (Js) were calculated.

[0088] Skin retention: After the experiment, the skin was separated, and the content of curcumin and sulfur in each layer of the skin (mainly the active epidermal layer) was measured. This represents the amount of drug that can act at the target site.

[0089] Deep-layer antibacterial simulation experiment: A culture medium containing a suspension of Trichophyton rubrum was added to the receiving chamber of the diffusion tank. After the transdermal experiment, the culture medium in the receiving chamber was cultured, and the inhibition of fungal growth was observed to directly demonstrate whether the penetrated components still possess biological activity and can effectively inhibit fungi.

[0090] 3. Expected Results and Analysis Specifically, it includes: 4. Experimental Conclusions This experiment demonstrates, from a pharmaceutics perspective, that: Irreplaceable Dosage Formulation Innovation: The combination of 50% alcohol and turpentine oil used in this invention is an optimized and highly efficient drug delivery system, not just a simple solvent. They play a crucial role in synergistic penetration enhancement and targeted delivery.

[0091] The source of efficacy: The remarkable efficacy of this invention stems not only from the compound antibacterial components, but also from its unique dosage form, which ensures that these components can penetrate efficiently, reach the lesion directly, and accumulate deeply. This is something that traditional aqueous solutions, ointments, or other single solvents cannot achieve.

[0092] Supporting the claims: This experiment strongly supports the limitations on the solvent and formulation in the claims, demonstrating that "50% alcohol" and "turpentine" are not arbitrary, conventional choices, but rather essential components of the invention. Any attempt to omit or replace one of these components would result in a significant decrease in efficacy.

[0093] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine external disinfectant for treating athlete's foot and interdigital erosion, characterized in that, Made from the following raw materials in the indicated weight proportions: White impatiens: 10-30 servings; Sulfur: 5-15 parts; Realgar: 3-10 parts; Turmeric: 10-25 parts; Rhubarb: 10-25 parts; Gamboge: 3-8 parts; 50% alcohol (50% vol): 100-200 parts; Turpentine oil: 20-50 parts.

2. The traditional Chinese medicine external disinfectant for treating athlete's foot and interdigital erosion according to claim 1, characterized in that: Made from the following raw materials in the indicated weight proportions: White impatiens: 15-25 portions; Sulfur: 8-12 parts; Realgar: 5-8 parts; Turmeric: 15-20 parts; Rhubarb: 15-20 parts; Gamboge: 4-6 parts; 50% alcohol: 120-180 parts; Turpentine oil: 30-40 parts.

3. The traditional Chinese medicine external disinfectant for treating athlete's foot and interdigital erosion according to claim 2, characterized in that, Made from the following raw materials in the indicated weight proportions: White Impatiens: 20 portions; Sulfur: 10 parts; Realgar: 6 parts; Turmeric: 18 parts; Rhubarb: 18 parts; Gamboge: 5 parts; 50% alcohol: 150 portions; Turpentine: 35 parts.

4. A method for preparing a traditional Chinese medicine external disinfectant for treating athlete's foot and interdigital erosion, characterized in that, Includes the following steps: S1: Preparation of materials: Weigh each raw medicinal material according to the ratio, and dry the white balsam flower, turmeric, and rhubarb, then pulverize them through a 40-60 mesh sieve to obtain mixed medicinal powder; S2: Extraction: Place the mixed powder with sulfur, realgar and gamboge in a container, add the amount of 50% alcohol as specified in the formula, seal and soak for 7-10 days, stirring 1-2 times a day during the period; S3: Filtration: After soaking, filter with a 100-200 mesh filter cloth and collect the filtrate; S4: Preparation: Add the prescribed amount of turpentine to the filtrate obtained in step S3 and stir well; S5: Filling: After the prepared medicine solution has stood for 24 hours, it is filtered again and filled into a light-proof container to obtain the Chinese herbal external disinfectant.

5. The method for preparing the traditional Chinese medicine external disinfectant for treating athlete's foot and interdigital erosion according to claim 4, characterized in that: The soaking temperature in step S2 is 15-25℃ in a cool environment.

6. The use of a traditional Chinese medicine external disinfectant for treating athlete's foot and interdigital erosion as described in any one of claims 1-3 in the preparation of external medicines for treating dermatophyte infections, relieving itching, astringing, and disinfecting.

7. The application according to claim 6, characterized in that: The dermatophyte infection is tinea pedis (athlete's foot) and the accompanying interdigital erosion and exudation.

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