External traditional Chinese medicine preparation for treating erosive tinea pedis and capable of quickly relieving itching and recovering and preparation method of external traditional Chinese medicine preparation

Abstract

The invention discloses an erosive tinea pedis traditional Chinese medicine external preparation for quick-acting itching relieving and rehabilitation and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine external preparations. The preparation is prepared from 80 to 120 parts of flos caryophylli, 40 to 60 parts of rhizoma polygoni cuspidati, 180 to 220 parts of fructus psoraleae, 40 to 60 parts of alumen and 1800 to 2200 parts of alcohol with the volume fraction of 70 to 95 percent. The preparation method comprises the steps of raw material pretreatment, earthen jar soaking, twice filtering, alum dissolution and the like. The preparation disclosed by the invention has the characteristics of quickly relieving itching, promoting healing of an erosive surface and reducing relapse, and is suitable for treating erosive tinea pedis.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine external preparations technology, specifically relating to an external liquid medicine for treating erosive tinea pedis based on a traditional Chinese medicine composition and its preparation method. Background Technology

[0002] Erosive tinea pedis is a common skin disease caused by dermatophyte infection of the foot. Clinically, it manifests as maceration, erosion, and oozing of the skin between the toes, accompanied by intense itching. It is prone to secondary bacterial infections, and conventional treatments suffer from problems such as the high irritation of Western medicines and the slow onset of action and high recurrence rate of traditional Chinese medicine preparations. Currently, many commercially available Chinese herbal foot baths use single bactericidal ingredients, which lack sufficient synergistic effects on skin repair and preventing recurrence. While traditional remedies have some efficacy, their simple preparation processes (such as simple soaking) result in low dissolution rates of active ingredients, failing to meet the needs for rapid itch relief and wound healing. Therefore, there is an urgent need to develop a Chinese herbal topical preparation with a reasonable process, rapid onset of action, and significant anti-recurrence effect. Summary of the Invention

[0003] The purpose of this invention is to provide a fast-acting, itch-relieving, and rehabilitating traditional Chinese medicine external preparation for erosive tinea pedis, and its preparation method.

[0004] To achieve the above objectives, the present invention provides the following technical solution: a fast-acting, antipruritic, and rehabilitating traditional Chinese medicine external preparation for erosive tinea pedis, characterized in that it is made from the following raw materials in parts by weight: 80-120 parts clove, 40-60 parts Polygonum cuspidatum, 180-220 parts Psoralea corylifolia, 40-60 parts alum, and 1800-2200 parts alcohol; wherein the volume fraction of the alcohol is 70%-95%. Clove contains eugenol (content ≥8%), which has antifungal and nerve ending sensitivity-inhibiting effects; emodin in Polygonum cuspidatum (content ≥3%) can reduce local inflammation; psoralen (content ≥1.5%) promotes keratinocyte proliferation; alum (hydrated potassium aluminum sulfate) reduces exudate through astringent action; the alcohol concentration is preferably 75% (volume fraction) to balance bactericidal efficacy and skin irritation. Defining the core components and their proportions ensures the synergistic effect of the composition, covering the basic framework of the claims.

[0005] Furthermore, the weight proportions of each raw material are as follows: 100 parts clove, 50 parts Polygonum cuspidatum, 200 parts Psoralea corylifolia, 50 parts alum, and 2000 parts alcohol; the volume fraction of the alcohol is 75%. Through orthogonal experiments, it was verified that at this ratio, the eugenol dissolution rate is ≥85%, the alum solubility is over 90%, and the clinical verification shows an antipruritic effect of ≤30 minutes; at an alcohol concentration of 75% (volume fraction), the inhibition zone diameter against Staphylococcus aureus is ≥15mm (plate diffusion method). Defining the optimal implementation parameters enhances the practicality of the patent and prevents others from circumventing infringement by simply adjusting the proportions.

[0006] Furthermore, the following steps are included:

[0007] S1: Raw material pretreatment: Wash cloves, Japanese knotweed and psoralea corylifolia 2-3 times with purified water, air dry until the moisture content is ≤8%, grind into 20-mesh coarse powder and mix them;

[0008] S2: First soaking: Place the mixed coarse powder in a ceramic jar, add the alcohol, and soak at 20-25℃ in the dark for 15 days, stirring once a day (30-60 rpm, 10 minutes each time);

[0009] S3: First filtration: Filter the soaking solution with double-layered 200-mesh gauze and collect the filtrate;

[0010] S4: Alum treatment: Grind alum into 80-mesh fine powder;

[0011] S5: Mixing and dissolving: Add alum powder to the filtrate, stir at 50 rpm for 30 minutes, and let stand for 24 hours;

[0012] S6: Second filtration: Filter using a 0.45μm polyethersulfone microporous membrane and collect the filtrate.

[0013] S1: Air-dry at a temperature of 15-20℃ and a humidity of 40%-50% to prevent the medicinal materials from becoming moldy;

[0014] S2: The earthenware urn is made of coarse pottery with an iron content of ≤1%, and its volume is 1.5-2 times the volume of the liquid to promote the dissolution of effective ingredients;

[0015] S6: 0.45μm polyethersulfone filter membrane (molecular weight cutoff ≥10kDa) to ensure the sterility of the formulation.

[0016] Build a complete process chain, clarify key process parameters, and prevent others from reducing the quality of the formulation by simplifying steps or replacing materials.

[0017] Furthermore, the air-drying conditions described in step S1 are a temperature of 15-20℃ and a relative humidity of 40%-50%. Temperatures >25℃ result in a degradation rate of emodin in Polygonum cuspidatum ≥15%, and humidity >50% results in a total bacterial count ≥10 on the surface of the medicinal material. 3 CFU / g (refer to the microbial limit standards in the 2020 edition of the Chinese Pharmacopoeia). Key process parameters are limited to ensure the quality of medicinal material pretreatment and avoid the impact of environmental fluctuations on the stability of the formulation.

[0018] Furthermore, the volume of the ceramic urn mentioned in step S2 is 1.5-2 times the total volume of the soaking solution. If the volume of the ceramic urn is too small (<1.5 times), it leads to insufficient dissolved oxygen, reducing the dissolution rate of effective ingredients by 20%; if the volume is too large (>2 times), it increases the amount of alcohol used, increasing costs by 30%. This combination of material characteristics and process effects prevents others from circumventing the core process by selecting the appropriate container.

[0019] Furthermore, the stirring speed in step S2 is 30-60 rpm. A speed <30 rpm reduces the dissolution rate of the medicinal components by 15%, while a speed >60 rpm leads to the destruction of the alum crystal structure (particle size <50μm accounts for >50%). Limiting the dynamic extraction conditions ensures the full release of the active ingredients and prevents others from reducing the efficacy through differences in stirring intensity.

[0020] Furthermore, the double-layer gauze described in step S3 has a mesh size of 200. 200-mesh gauze (pore size ≈ 75μm) can intercept medicinal fiber (length > 2mm, percentage > 90%), and has a light transmittance > 90% (visible light wavelength 550nm). Clearly defined filtration standards prevent the use of low-precision filter materials by others, which could lead to turbidity in the preparation.

[0021] Furthermore, the amount of alum powder added in step S5 is 2.5%-3.5% (w / v) of the filtrate volume. When the alum concentration is <2.5%, the pH is <4.0, and the antibacterial effect decreases (antibacterial rate against Trichophyton rubrum <60%); when the concentration is >3.5%, the pH is >5.0, and the local irritation score is ≥2 points (VAS score). Quantifying the amount of excipients prevents others from disrupting the compatibility balance through dosage adjustments.

[0022] Furthermore, the microporous filter membrane described in step S6 is made of polyethersulfone (PES). PES is heat-resistant (150°C) and has low protein adsorption (<0.1%), making it superior to nylon (which easily swells) and cellulose esters (which have poor chemical stability). This limitation on filter material characteristics prevents others from affecting the sterility of the formulation through material substitution.

[0023] This invention provides a fast-acting, antipruritic, and rehabilitating traditional Chinese medicine external preparation for erosive tinea pedis, and its preparation method, which has the following beneficial effects:

[0024] (1) Quick relief of itching: Clove volatile oil (such as eugenol) can quickly inhibit the sensitive reaction of skin nerve endings, and the astringent effect of alum can reduce exudate. The two work together to relieve itching within 30 minutes.

[0025] (2) Promote wound repair: Emodin in Polygonum cuspidatum has anti-inflammatory and antibacterial effects, which can reduce local inflammatory reactions; psoralen can regulate the proliferation and differentiation of skin keratinocytes, accelerate the regeneration of epidermis on eroded surfaces, and shorten the healing cycle (clinical observation shows that most patients can see the wound dry and scab over in 5-7 days).

[0026] (3) Anti-recurrence properties: The Chinese medicine composition reduces the recurrence rate by regulating the local microecological balance (inhibiting excessive fungal growth) and enhancing the skin barrier function (promoting stratum corneum repair). (After clinical verification in 200 cases, the recurrence rate in 3 months was ≤15%, which was significantly lower than the 40% in the Western medicine group.)

[0027] (4) Process rationality: The use of ceramic urn for light-proof soaking improves the dissolution rate of active ingredients. Two filtrations combined with microporous membranes remove impurities to ensure the clarity of the preparation. Alum is dissolved after grinding to ensure uniformity. Process parameters (temperature, speed and time) are optimized to ensure stable quality between batches. Detailed Implementation

[0028] Exemplary embodiments will now be described in detail. The embodiments described in the following exemplary embodiments do not represent all embodiments consistent with this disclosure. Rather, they are merely examples of apparatuses consistent with some aspects of this disclosure as detailed in the appended claims.

[0029] Example 1: Basic Formulation Validation

[0030] 100g cloves, 50g Japanese knotweed, 200g psoralea corylifolia, 50g alum, 2000ml 75% alcohol

[0031] Soak in earthenware jar for 15 days (stirring daily at 50 rpm) → filter through double-layer 200-mesh gauze → add ground alum → finely filter through 0.45μm polyethersulfone membrane.

[0032] Effect:

[0033]

[0034]

[0035] Verify the feasibility of the core formulation and process, serving as a benchmark for subsequent embodiments.

[0036] Example 2: Optimization of soaking time

[0037] The soaking time for 100g cloves, 50g Japanese knotweed, 200g psoralea corylifolia, 50g alum, and 2000ml 75% alcohol in a ceramic urn was adjusted to 12 days (other steps are the same as in Example 1).

[0038] Effect:

[0039]

[0040]

[0041] This proves that the soaking time needs to be ≥15 days to ensure that the active ingredients are fully dissolved.

[0042] Example 3: Comparison of stirring intensity

[0043] 100g cloves, 50g Japanese knotweed, 200g psoralea corylifolia, 50g alum, and 2000ml 75% alcohol were soaked. During the soaking process, the stirring speed was adjusted to 20 rpm (other steps are the same as in Example 1).

[0044] Effect:

[0045] index data Residual amount of medicinal residue 15g (50% increase) Alum solubility 88％ Clarity (transmittance) of the formulation 82% (95% in Example 1)

[0046] Purpose: To verify the effect of stirring intensity on extraction efficiency and formulation quality.

[0047] Example 4: Adjustment of alum dosage

[0048] 100g cloves, 50g Japanese knotweed, 200g psoralea corylifolia, 60g alum, 2000ml 75% alcohol. Other steps are the same as in Example 1.

[0049] Effect:

[0050] index data pH 4.8 (4.5 for Example 1) Local irritation score 1.8 points (VAS) Antibacterial rate (72 hours) 98% (99% in Example 1)

[0051] To verify the balancing effect of alum dosage on safety and antibacterial efficacy.

[0052] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A fast-acting, antipruritic, and rehabilitating traditional Chinese medicine external preparation for erosive tinea pedis and its preparation method, characterized in that, It is made from the following raw materials in parts by weight: 80-120 parts cloves, 40-60 parts Polygonum cuspidatum, 180-220 parts Psoralea corylifolia, 40-60 parts alum, and 1800-2200 parts alcohol; wherein the volume fraction of the alcohol is 70%-95%.

2. The topical Chinese medicine preparation for rapid itch relief and recovery from erosive tinea pedis according to claim 1, and its preparation method, is characterized in that, The weight parts of each raw material are as follows: 100 parts cloves, 50 parts Japanese knotweed, 200 parts psoralea corylifolia, 50 parts alum, and 2000 parts alcohol; the volume fraction of the alcohol is 75%.

3. The topical Chinese medicine preparation for rapid itch relief and recovery from erosive tinea pedis according to claim 1, and its preparation method, is characterized in that... Includes the following steps: S1: Raw material pretreatment: Wash cloves, Japanese knotweed and psoralea corylifolia 2-3 times with purified water, air dry until the moisture content is ≤8%, grind into 20-mesh coarse powder and mix them; S2: First soaking: Place the mixed coarse powder in a ceramic jar, add the alcohol, and soak at 20-25℃ in the dark for 15 days, stirring once a day (30-60 rpm, 10 minutes each time); S3: First filtration: Filter the soaking solution with double-layered 200-mesh gauze and collect the filtrate; S4: Alum treatment: Grind alum into 80-mesh fine powder; S5: Mixing and dissolving: Add alum powder to the filtrate, stir at 50 rpm for 30 minutes, and let stand for 24 hours; S6: Second filtration: Filter using a 0.45μm polyethersulfone microporous membrane and collect the filtrate.

4. The topical Chinese medicine preparation for rapid itch relief and recovery from erosive tinea pedis according to claim 3, and its preparation method, characterized in that, The conditions for air drying in step S1 are a temperature of 15-20℃ and a relative humidity of 40%-50%.

5. The topical Chinese medicine preparation for rapid itch relief and recovery from erosive tinea pedis according to claim 3, and its preparation method, characterized in that, The volume of the earthenware urn mentioned in step S2 is 1.5-2 times the total volume of the soaking liquid.

6. The topical Chinese medicine preparation for rapid itch relief and recovery from erosive tinea pedis according to claim 3, and its preparation method, characterized in that, The stirring speed in step S2 is 30-60 rpm.

7. The topical Chinese medicine preparation for rapid relief and recovery from erosive tinea pedis according to claim 3, and its preparation method, is characterized in that... The double-layer gauze in step S3 has a mesh size of 200.

8. The topical Chinese medicine preparation for rapid itch relief and recovery from erosive tinea pedis according to claim 3, and its preparation method, characterized in that, The amount of alum powder added in step S5 is 2.5%-3.5% (w / v) of the volume of the filtrate.

9. The topical Chinese medicine preparation for rapid itch relief and recovery from erosive tinea pedis according to claim 3, and its preparation method, characterized in that, The microporous filter membrane mentioned in step S6 is made of polyethersulfone.

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