A traditional Chinese medicine composition for treating dermatophytosis and application thereof

Abstract

The application discloses a traditional Chinese medicine composition for treating skin tinea, which is made of the following components in parts by weight: 20-40 parts of Sophora flavescens, 10-20 parts of Stachys robusta, 10-20 parts of Kochia scoparia, 10-40 parts of Solpugid, 20-40 parts of Sphaeropsidipus, 20-40 parts of Phellodendron, 20-40 parts of Dictamnus dasycarpus, 20-40 parts of Cnidium monnieri, 10-20 parts of Melioidzine, 10-20 parts of Zanthoxylum bungeanum and 10-20 parts of Scophularia ningpoensis. In the traditional Chinese medicine composition, Sophora flavescens, Phellodendron and Dictamnus dasycarpus can clear heat and dry dampness, Stachys robusta, Kochia scoparia, Solpugid, Sphaeropsidipus, Cnidium monnieri and Scophularia ningpoensis have the effect of killing insects and stopping itching; in addition, Melioidzine can invigorate the spleen and dispel wind, and Zanthoxylum bungeanum can increase the transdermal effect of the composition, so that the whole composition can better play the treatment role of clearing heat and dry dampness, killing insects and stopping itching.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically, it relates to a traditional Chinese medicine composition for treating tinea and its application. Background Technology

[0002] Tinea is a superficial fungal skin disease that occurs on the epidermis, hair, and nails. It is characterized by its contagiousness, long-term nature, and widespread nature, and has always been a focus of skin disease prevention and control. This disease has different names depending on the location of its occurrence, such as tinea capitis (white tinea) or tinea favosa (yellow tinea) on the scalp, tinea manuum (hand tinea) on the hands, and tinea corporis (body tinea) or tinea versicolor (pityriasis versicolor) on the face, neck, and trunk.

[0003] Traditional Chinese medicine believes that the cause of this disease is due to improper lifestyle, fungal infection, and external invasion of wind, dampness, and heat, which stagnate in the skin and spread to the pores. When it occurs on the scalp and hair, it manifests as tinea capitis or tinea pedis; when it occurs between the toes, it manifests as athlete's foot; when it occurs on the palms, it manifests as tinea pedis; and when it occurs on the body surface and groin, it manifests as tinea purpura, tinea corporis, or tinea pubis. If the symptoms include fever, rash, itching, and scaling, it is often due to excessive wind-heat; if there is oozing, itching, and crusting, it is often due to excessive damp-heat; and if the skin is thickened, dry, cracked, and itchy, it is often due to stagnant heat transforming into dryness, disharmony of qi and blood, and lack of nourishment for the skin.

[0004] Current treatment focuses on killing parasites and relieving itching. Targeted treatment mainly includes oral and topical medications, while also improving the patient's immunity to prevent infection and reinfection. Summary of the Invention

[0005] To address the problems of drug resistance easily arising from topical medications and drug-induced liver damage easily arising from oral medications in existing treatments, the purpose of this invention is to provide a traditional Chinese medicine composition for treating tinea.

[0006] Another object of the present invention is to provide the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating tinea.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0008] The first aspect of the present invention provides a traditional Chinese medicine composition for treating tinea, which is made of the following components in parts by weight:

[0009] Sophora flavescens 20-40 parts, Stemona japonica 10-20 parts, Hibiscus syriacus bark 10-20 parts, Euphorbia fischeriana 10-40 parts, Buthus martensii 3-12 parts, Pseudolarix amabilis bark 20-40 parts, Phellodendron chinense bark 20-40 parts, Dictamnus dasycarpus bark 20-40 parts, Cnidium monnieri 20-40 parts, Vespa nidus 10-20 parts, Zanthoxylum bungeanum 10-20 parts, Gallus gallus domesticus gizzard lining 10-20 parts.

[0010] The traditional Chinese medicine composition for treating tinea is made from the following components in parts by weight: 30 parts Sophora flavescens, 15 parts Stemona japonica, 15 parts Hibiscus syriacus bark, 15 parts Euphorbia fischeriana, 6 parts Buthus martensii, 30 parts Pseudolarix amabilis bark, 30 parts Phellodendron chinense bark, 30 parts Dictamnus dasycarpus bark, 30 parts Cnidium monnieri, 15 parts Vespa nidus, 15 parts Zanthoxylum bungeanum, and 15 parts Gallus gallus domesticus gizzard lining.

[0011] The traditional Chinese medicine composition for treating tinea is made from the following components in parts by weight: 20 parts Sophora flavescens, 10 parts Stemona japonica, 10 parts Hibiscus syriacus bark, 10 parts Euphorbia fischeriana, 3 parts Buthus martensii, 20 parts Pseudolarix amabilis bark, 20 parts Phellodendron chinense bark, 20 parts Dictamnus dasycarpus bark, 20 parts Cnidium monnieri, 10 parts Vespa nidus, 10 parts Zanthoxylum bungeanum, and 10 parts Gallus gallus domesticus gizzard lining.

[0012] The traditional Chinese medicine composition for treating tinea is made from the following components in parts by weight: 40 parts Sophora flavescens, 20 parts Stemona japonica, 20 parts Hibiscus syriacus bark, 40 parts Euphorbia fischeriana, 12 parts Buthus martensii, 40 parts Pseudolarix amabilis bark, 40 parts Phellodendron chinense bark, 40 parts Dictamnus dasycarpus bark, 40 parts Cnidium monnieri, 20 parts Vespa nidus, 20 parts Zanthoxylum bungeanum, and 20 parts Gallus gallus domesticus gizzard lining.

[0013] In the traditional Chinese medicine composition for treating tinea of ​​the present invention, the principal ingredient is Sophora flavescens, the assistant ingredients are Stemona japonica, Hibiscus syriacus bark, Euphorbia fischeriana, Pseudolarix amabilis bark, and Cnidium monnieri; the adjuvant ingredients are Buthus martensii, Phellodendron chinense bark, Dictamnus dasycarpus bark, Vespa nidus, and Gallus gallus domesticus gizzard lining; and the guiding ingredient is Zanthoxylum bungeanum.

[0014] The properties, meridians, functions, and common dosages of each drug in the formulation of this invention are as follows:

[0015] Sophora flavescens: Properties: Bitter, cold. Meridians: Heart, Liver, Stomach, Large Intestine, Bladder. Functions: Clears heat and dries dampness, kills parasites and relieves itching. For external use, apply appropriate amount.

[0016] Stemona japonica: Properties: Sweet, bitter, slightly warm. Enters the Lung Meridian. Functions: Kills insects and lice. For external use, apply appropriate amount.

[0017] Hibiscus bark: Taste and nature: sweet and bitter, slightly cold. Meridians: Large intestine, liver, heart, lung, stomach, spleen. Functions: Clears heat and promotes diuresis, kills parasites and relieves itching. For external use, apply appropriate amount.

[0018] Wolfsbane: Properties: Bitter, pungent, neutral. Toxic. Enters the lung, spleen, and liver meridians. Functions: Drains water retention, breaks up accumulations, and kills parasites. For external use, apply appropriate amount.

[0019] Whole scorpion: Properties: pungent, neutral. Toxic. Enters the liver meridian. Functions: calms wind and stops spasms, attacks toxins and dissipates nodules. For external use, apply appropriate amount.

[0020] Pseudolarix bark: Properties: pungent, warm. Meridians: Lung, Spleen. Functions: Insecticidal, treats tinea, dispels dampness and relieves itching. For external use, apply appropriate amount.

[0021] Phellodendron bark: Properties: Bitter, cold. Meridians: Kidney, Bladder, Large Intestine. Functions: Clears heat and dries dampness, drains fire and detoxifies. For external use, apply appropriate amount.

[0022] Dictamnus dasycarpus root bark: Properties: Bitter, cold. Meridians: Spleen, Stomach, Bladder. Functions: Clears heat and dampness, detoxifies and relieves itching. For external use, apply appropriate amount.

[0023] Cnidium monnieri: Properties: pungent, bitter, warm. Slightly toxic. Enters the kidney meridian. Functions: kills parasites and relieves itching, dries dampness and dispels wind. For external use, apply appropriate amount.

[0024] Beehive: Properties: Sweet, neutral. Meridian: Stomach. Functions: Detoxifies and kills parasites, dispels wind and relieves pain. For external use, apply appropriate amount.

[0025] Sichuan pepper: Properties: pungent, warm. Meridians: spleen, stomach, kidney. Functions: dries dampness, kills parasites, relieves itching. For external use, apply appropriate amount.

[0026] Chicken gizzard lining: Taste and nature: sweet, neutral. Meridians: spleen, stomach, small intestine, bladder. Functions: aids digestion, strengthens the stomach, dissolves stones, and promotes urination. For external use, apply appropriate amount.

[0027] Explanation: This formula uses Sophora flavescens as the principal herb to clear heat and dry dampness, guiding the entire formula. The assistant herbs are Stemona japonica, Hibiscus syriacus bark, Euphorbia fischeriana, Pseudolarix amabilis bark, and Cnidium monnieri to kill parasites and relieve itching. It is further supplemented with Scorpion and Vespa nidus to dispel wind and attack toxins; Phellodendron chinense and Dictamnus dasycarpus bark to clear heat, dry dampness, and relieve itching; Chicken gizzard membrane to strengthen the spleen and dispel wind; and finally, Zanthoxylum bungeanum as the guiding herb to enhance the transdermal effect of the formula. The entire formula works synergistically to clear heat, dry dampness, kill parasites, and relieve itching.

[0028] In a second aspect, the present invention provides the use of the traditional Chinese medicine composition in the preparation of a medicament for treating tinea.

[0029] In a third aspect, the present invention provides a traditional Chinese medicine preparation made from the above-mentioned traditional Chinese medicine composition, wherein the dosage form of the traditional Chinese medicine preparation is selected from cream, decoction, tablet, mixture, oral liquid, granule, pill, capsule, umbilical patch, and suppository.

[0030] By adopting the above technical solution, the present invention has the following advantages and beneficial effects:

[0031] In the traditional Chinese medicine composition of this invention, Sophora flavescens, Phellodendron chinense, and Dictamnus dasycarpus can clear heat and dry dampness; Stemona japonica, Hibiscus syriacus, Euphorbia fischeriana, Pseudolarix amabilis, and Cnidium monnieri have the effects of killing parasites and relieving itching; Scorpion and Vespa nidus are added to dispel wind and attack toxins; Chicken gizzard membrane strengthens the spleen and dispels wind; and Zanthoxylum bungeanum increases the transdermal effect of this formula, so that the whole formula can better exert its therapeutic effects of clearing heat and drying dampness, killing parasites and relieving itching.

[0032] The herbal composition cream of the present invention is suitable for treating skin fungal diseases such as tinea corporis, tinea manuum, and tinea pedis. It has good efficacy and significantly improves erythema, papules, and desquamation in guinea pig models of tinea corporis. It can inhibit the growth of mycelial spores in the skin lesions of mice, has good antifungal effect, and has no obvious skin toxicity or irritation. Attached Figure Description

[0033] Figure 1 This is a diagram showing the condition of the guinea pig's skin after administration of the drug.

[0034] Figure 2 This is a schematic diagram of the skin lesion scoring results for each group of guinea pigs.

[0035] Figure 3 This is a schematic diagram of the results of guinea pig skin sample culture after drug administration.

[0036] Figure 4 This is a schematic diagram of the results of culture and staining analysis of guinea pig skin samples after drug administration.

[0037] Figure 5 This is a schematic diagram of the results of a rat skin toxicity test.

[0038] Figure 6 This is a schematic diagram showing the skin irritation results of rats 72 hours after applying a traditional Chinese medicine composition cream. Detailed Implementation

[0039] To more clearly illustrate the present invention, the following description, in conjunction with preferred embodiments, further clarifies the invention. Those skilled in the art should understand that the specific descriptions below are illustrative rather than restrictive, and should not be construed as limiting the scope of protection of the present invention.

[0040] Example 1

[0041] A traditional Chinese medicine composition for treating tinea is made from the following components by weight:

[0042] Sophora flavescens 30g, Stemona japonica 15g, Hibiscus syriacus bark 15g, Euphorbia fischeriana 15g, Buthus martensii 6g, Pseudolarix amabilis bark 30g, Phellodendron chinense bark 30g, Dictamnus dasycarpus bark 30g, Cnidium monnieri 30g, Vespa nidus 15g, Zanthoxylum bungeanum 15g, Gallus gallus domesticus gizzard lining 15g.

[0043] A method for preparing a traditional Chinese medicine composition cream for treating tinea includes the following steps:

[0044] The first step involved weighing out the following herbs: Sophora flavescens, Stemona japonica, Hibiscus syriacus bark, Euphorbia fischeriana, Buthus martensii, Pseudolarix amabilis bark, Phellodendron chinense bark, Dictamnus dasycarpus bark, Cnidium monnieri, Vespa nidus, Zanthoxylum bungeanum, and Gallus gallus domesticus gizzard lining. After initial mixing, the herbs were coarsely pulverized using a high-speed grinder and weighed again. Then, 20 times the weight of the powdered herbs in distilled water was added, and the mixture was extracted using a high-temperature heating mantle for 1.5 hours. The decoction was allowed to stand, centrifuged, and filtered twice. This process was repeated three times (each time with 20 times the weight of water). The three decoctions were combined and dynamically concentrated under vacuum at 60°C using a rotary evaporator to obtain a fluid extract.

[0045] The second step involves weighing the components according to the following proportions: oil phase: 1g borneol, 1g paraffin, 1g beeswax, 5g liquid paraffin, 2.4g glyceryl monostearate, 1g white petrolatum, 0.4g Span-80; aqueous phase: 4g fluid extract obtained in the first step, 0.6g alum, 0.2g Tween-80, and 10g 2% NaOH aqueous solution. The oil and aqueous phases are then placed separately in an 80℃ water bath for homogenization. While still hot, the oil phase is poured into the aqueous phase, and emulsified using a high-speed homogenizer at 3000 rpm for 5 minutes to obtain a brownish-yellow cream.

[0046] Example 2

[0047] A traditional Chinese medicine composition for treating tinea is made from the following components by weight:

[0048] Sophora flavescens 20g, Stemona japonica 10g, Hibiscus syriacus bark 10g, Euphorbia fischeriana 10g, Buthus martensii 3g, Pseudolarix amabilis bark 20g, Phellodendron chinense bark 20g, Dictamnus dasycarpus bark 20g, Cnidium monnieri 20g, Vespa nidus 10g, Zanthoxylum bungeanum 10g, Gallus gallus domesticus gizzard lining 10g.

[0049] A method for preparing a decoction of a traditional Chinese medicine composition for treating tinea includes the following steps:

[0050] The first step is to weigh out the following herbs separately: Sophora flavescens, Stemona japonica, Hibiscus syriacus bark, Euphorbia fischeriana, Buthus martensii, Pseudolarix amabilis bark, Phellodendron chinense bark, Dictamnus dasycarpus bark, Cnidium monnieri, Vespa nidus, Zanthoxylum bungeanum, and chicken gizzard lining. After initial mixing, use a high-speed grinder to coarsely grind the herbs and then weigh them.

[0051] In the second step, add 10 times the weight of the medicinal powder to distilled water and soak thoroughly for 30 minutes. Then, heat with a high-temperature electric heating mantle for 1 hour to extract the liquid. Let the decoction stand, centrifuge to collect the liquid, and then filter. Repeat the above decoction, centrifugation, and filtration process once. Combine the two decoctions to obtain the traditional Chinese medicine composition decoction.

[0052] Example 3

[0053] A traditional Chinese medicine composition for treating tinea is made from the following components by weight:

[0054] Sophora flavescens 40g, Stemona japonica 20g, Hibiscus syriacus bark 20g, Euphorbia fischeriana 40g, Buthus martensii 12g, Pseudolarix amabilis bark 40g, Phellodendron chinense bark 40g, Dictamnus dasycarpus bark 40g, Cnidium monnieri 40g, Vespa nidus 20g, Zanthoxylum bungeanum 20g, Gallus gallus domesticus gizzard lining 20g.

[0055] A method for preparing a traditional Chinese medicine composition granule for treating tinea includes the following steps:

[0056] The first step involves separately weighing out the following herbs: Sophora flavescens, Stemona japonica, Hibiscus syriacus bark, Euphorbia fischeriana, Buthus martensii, Pseudolarix amabilis bark, Phellodendron chinense bark, Dictamnus dasycarpus bark, Cnidium monnieri, Vespa nidus, Zanthoxylum bungeanum, and Gallus gallus domesticus gizzard lining. After preliminary mixing, the herbs are coarsely pulverized using a high-speed grinder and weighed again. Then, 20 times the weight of the powdered herbs in distilled water is added, and the mixture is heated in a high-temperature electric heating mantle for 1.5 hours. The decoction is allowed to stand, centrifuged, and then filtered. This decoction process is repeated three times, and the resulting decoctions are combined. The three decoctions are then combined to obtain a mixed decoction.

[0057] The second step involves vacuum freeze-drying the mixed decoction to obtain a compound freeze-dried powder of traditional Chinese medicine. The freeze-dried powder, sugar powder, and dextrin are mixed in a weight ratio of 1:2:4 and sieved to obtain a dry mixture. This mixture is then further vacuum-dried to a constant weight to obtain granules of the traditional Chinese medicine composition.

[0058] Example 4

[0059] Application of a traditional Chinese medicine composition cream for treating tinea in animal models of tinea:

[0060] I. Preparation of animal experimental models of tinea:

[0061] Twenty-four healthy guinea pigs of ordinary grade were raised for 7 days to adapt to the experimental environment and then randomly divided into four groups of 10 each according to their weight. These groups were named: blank group, model group, positive control group (ketoconazole cream), and treatment group (the traditional Chinese medicine composition cream prepared in Example 1). The hair on one side of the guinea pig's back was trimmed to an area of ​​approximately 4cm × 4cm. An appropriate amount of depilatory cream was then applied to the trimmed area. After several minutes, the cream was washed off with warm water. The skin at the depilated area was examined for damage or drug residue. The guinea pigs were anesthetized with 10% chloral hydrate solution, and the skin was abraded with sterile sandpaper until bleeding occurred. The area was then disinfected with 75% ethanol. After the disinfected area dried, a 1×10⁻⁶ dose of the herbal composition cream was prepared. 8 300 μL of a CFU / mL suspension of Trichophyton mentagrophytes was evenly applied to the surface of the damaged skin. The appearance of obvious erythema, scaling, and other characteristics of tinea corporis on the skin indicated that the guinea pig model of tinea corporis was successfully established.

[0062] II. Animal experiments: drug administration methods and skin lesions:

[0063] After successful model preparation, the corresponding drugs were applied topically to the dorsal skin of guinea pigs. The control group received no treatment, the model group received 1 mg of purified water, the positive control group received 1 mg of ketoconazole cream, and the treatment group received 1 mg of the traditional Chinese medicine composition cream prepared in Example 1, twice daily for 14 consecutive days. Changes in the skin at the injection site were observed and assessed daily. After 14 days, the skin condition of each group was as follows: Figure 1 As shown, Figure 1 This is a diagram showing the condition of the guinea pig's skin after administration of the drug.

[0064] Skin lesions were scored based on the area of ​​erythema, the number of papules, and the severity of scaling. The scores for each animal in each group were summed, and comparisons were made between groups. After 14 days of treatment, the skin lesion scores were as follows: Figure 2 As shown, Figure 2 This is a schematic diagram of the skin lesion scores for each group of guinea pigs. As can be seen from the diagram, the skin lesion score in the model group was still significantly higher than that in the control group, while the treatment group and the positive control group showed significant improvement in the guinea pig tinea corporis skin lesions, and the treatment effect in the treatment group was better than that in the positive control group.

[0065] The skin lesion scoring criteria are shown in Table 1:

[0066] Table 1

[0067]

[0068] The results for each group are shown in Table 2:

[0069] Table 2

[0070] Blank group Model group Treatment group Ketoconazole cream erythema 0±0 <![CDATA[2.2±0.42 ## ]]> <![CDATA[0.7±0.67 ** ]]> <![CDATA[0.9±0.74 ** ]]> scaly 0±0 <![CDATA[2.6±0.52 ## ]]> <![CDATA[0.9±0.74 ** ]]> <![CDATA[1.1±0.74 ** ]]> papules 0±0 <![CDATA[1.7±0.67 ## ]]> <![CDATA[0.4±0.52 ** ]]> <![CDATA[0.5±0.53 ** ]]> Total Score 0±0 <![CDATA[6.5±1.18 ## ]]> <![CDATA[2.0±1.15 ** ]]> <![CDATA[2.5±1.35 ** ]]>

[0071] Note: Compared with the blank group, ## P < 0.01; compared with the model group, ** P < 0.01.

[0072] III. Skin Sample Culture

[0073] After treatment, a cotton swab was used to collect samples from the skin lesion, which were then inoculated onto a Sabouraud dextrose agar slant to detect the presence of bacterial colonies. Skin tissue samples were scraped from a glass slide, stained with Giemsa stain, and observed for the presence of spores.

[0074] The results are as follows Figure 3 and Figure 4 As shown, Figure 3 This is a schematic diagram of the results of guinea pig skin sample culture after drug administration. Figure 4 This is a schematic diagram of the results of culture and staining analysis of guinea pig skin samples after drug administration. Figure 3 The results showed that, except for the model group, no obvious spores or colonies grew in the other groups, indicating that both the treatment group and the positive control group had good antifungal effects. Figure 4 The staining results showed that the model group had a large number of hyphae and spores growing out, while the treatment group and the positive control group had no obvious spores or colonies growing out, indicating a good antifungal effect.

[0075] Example 5

[0076] A study on the skin toxicity of a traditional Chinese medicine composition cream for treating tinea in experimental animals:

[0077] I. Skin toxicity test

[0078] Fifty healthy SD rats, half male and half female, were selected. Hair was removed from a 3cm × 3cm area on the back of each rat 24 hours before administration. The rats were divided into 5 groups of 10 rats each. The excipient was applied to the hair-removed area at a dose of 1g / rat (blank control group). The herbal composition cream prepared in Example 1 was applied to the hair-removed area at a dose of 3g / rat (high-dose intact skin group). The herbal composition cream was applied to broken skin in the hair-removed area at a dose of 3g / rat (high-dose broken skin group). The herbal composition cream was applied to the hair-removed area at a dose of 1g / rat (low-dose intact skin group). The herbal composition cream was applied to broken skin in the hair-removed area at a dose of 1g / rat (low-dose broken skin group). After 24 hours, the test substance was removed with warm water and observed. Then, the same test substance was applied and repeated for 7 consecutive days. The rats' overall condition and mortality were observed, including changes in body weight, degree of redness and swelling of the skin in the hairless area, hair, eyes and mucous membranes, as well as changes in respiration, circulation, central nervous system, and limb movement.

[0079] The results of the effect of the traditional Chinese medicine composition cream on the skin toxicity of SD rats are shown in the figure. Figure 5 As shown, Figure 5 This is a schematic diagram of the results of the rat skin toxicity experiment. In the diagram, a represents the skin of the blank control group; b represents the skin of the high-dose broken skin group; c represents the skin of the low-dose broken skin group; d represents the skin of the high-dose intact skin group; and e represents the skin of the low-dose intact skin group. The results showed that after 7 days of application of the topical herbal composition cream, no obvious abnormal reactions were observed in the rats of the high-dose and low-dose intact skin groups. No abnormalities were observed in their mental state, spontaneous movement, eyes, hair, skin and mucous membranes, or respiration. No erythema or edema was observed in the local skin of the blank control group, and no deaths occurred. In the high-dose and low-dose broken skin groups, slight redness and swelling appeared at the original skin scratches, but no erythema or edema was observed around the scratches, and no deaths occurred. As shown in Table 3, all experimental animals showed normal weight gain, with no difference compared to the data of the blank control group (P > 0.05). These results indicate that the herbal composition cream prepared in Example 1 has minimal or no skin toxicity to ordinary SD rats.

[0080] Table 3. Effects of topical application of traditional Chinese medicine composition cream on rat body weight.

[0081]

[0082] II. Skin Irritation Test

[0083] Twenty healthy SD rats, both male and female, were selected. 24 hours before administration, the hair in a 3cm×3cm area on both sides of the rats was removed. The rats were divided into two groups of 10 each. A 16-gauge needle was used to make a "#" mark on the anesthetized, hairless and disinfected skin until the skin bled to break the skin.

[0084] The excipient was applied at a dose of 1 g / animal to the intact hair-removed skin area on the left side, and the herbal composition cream prepared in Example 1 was applied at a dose of 1 g / animal to the intact hair-removed skin area on the right side, forming the herbal composition cream intact skin group. The excipient was applied at a dose of 1 g / animal to the damaged hair-removed skin area on the left side, and the herbal composition cream was applied at a dose of 1 g / animal to the damaged hair-removed skin area on the right side, forming the herbal composition cream damaged skin group. After 24 hours, the test substances were removed with warm water, and the results were observed. The same test substances were then applied repeatedly for 3 consecutive days. The degree of irritation of the hair-removed skin in the guinea pigs was observed at 1 hour, 24 hours, 48 ​​hours, and 72 hours after the last application.

[0085] The skin irritation reaction score focuses on observing erythema and edema. Erythema is categorized into five levels: no erythema (0 points), mild erythema (barely visible) (1 point), moderate erythema (clearly visible) (2 points), severe erythema (3 points), and purplish-red erythema to mild eschar formation (4 points). Edema is categorized into five levels: no edema (0 points), mild edema (barely visible) (1 point), moderate edema (clearly visible) (2 points), severe edema (skin raised approximately 1 mm with a clear outline) (3 points), and extreme edema (skin raised more than 1 mm and expanding) (4 points). Intensity evaluation: The average irritation index score = (total erythema score + total edema score) / number of animals. A score ≤0.49 indicates no irritation, 0.5–2.99 indicates mild irritation, 3.0–5.99 indicates moderate irritation, and 6.0–8.0 indicates strong irritation.

[0086] See results for skin irritation. Figure 6 As shown, Figure 6This is a schematic diagram showing the skin irritation results in rats 72 hours after applying a traditional Chinese medicine composition cream. In the diagram, a represents the skin of the left side of the damaged skin area in the group with damaged skin treated with the traditional Chinese medicine composition cream; b represents the skin of the right side of the damaged skin area in the same group; c represents the skin of the left side of the intact skin area in the group with intact skin treated with the traditional Chinese medicine composition cream; and d represents the skin of the right side of the intact skin area in the same group. The results showed that, upon observation, in the rat group with intact skin after applying the herbal composition cream, no erythema or edema appeared at four time points: 1 h, 24 h, 48 h, and 72 h after the cream was applied and the test substance was removed. The skin morphology was the same as the area where the excipient was applied, and the average reaction intensity score for this group was less than 0.5. In the rat group with broken skin after applying the herbal composition cream, except for the dark red scabs that appeared after the sterile injection needle scratched normal skin, no erythema or edema appeared at four time points: 1 h, 24 h, 48 h, and 72 h after applying the herbal composition cream and removing the test substance. The skin morphology was the same as the area where the excipient was applied, and the average reaction intensity score for this group was also less than 0.5. These results indicate that the herbal composition cream is non-irritating to both normal and broken skin.

[0087] The scores for skin irritation reactions are shown in Tables 4 and 5:

[0088] Table 4

[0089]

[0090] Table 5

[0091]

[0092] III. Skin Allergy Test

[0093] Thirty healthy guinea pigs, half male and half female, were randomly divided into three groups of 10 each. Twenty-four hours before the experiment, hair was removed from a 3cm×3cm area on the back of each guinea pig. These groups were designated as the blank control group, the cream group containing the traditional Chinese medicine composition prepared in Example 1, and the positive control group.

[0094] The excipient was applied to the hair removal area at a dose of 1 g / animal as a blank control group; the traditional Chinese medicine composition cream was applied to the hair removal area at a dose of 1 g / animal as a traditional Chinese medicine composition cream group; and DNCB (1-chloro-2,4-dinitrobenzene) at a concentration of 1% was applied to the hair removal area at a dose of 0.1 mL / animal as a positive control group. The mixture was fixed with tape and left for 6 hours. The same method was repeated on day 7 and day 14.

[0095] Fourteen days after the last application of the drug to sensitize the guinea pigs, the herbal composition cream and excipients (approximately 0.3g / pig) and DNCB (0.1% concentration, approximately 0.1mL / pig) were applied to the hairless areas of the guinea pigs. The test substances were washed off with warm water after 6 hours. The guinea pigs were observed for allergic reactions at four time points: immediately, 24 hours, 48 ​​hours, and 72 hours, including the presence of local skin erythema, edema, and systemic allergic reactions such as difficulty breathing and abnormal activity.

[0096] The skin allergic reaction score is mainly based on erythema and edema. Erythema is categorized into five levels: no erythema (0 points), mild erythema (barely visible) (1 point), moderate erythema (clearly visible) (2 points), severe erythema (3 points), and purplish-red erythema to mild eschar formation (4 points). Edema is categorized into five levels: no edema (0 points), mild edema (barely visible) (1 point), moderate edema (clearly visible) (2 points), severe edema (skin raised approximately 1 mm with a clear outline) (3 points), and extreme edema (skin raised more than 1 mm and expanding) (4 points).

[0097] Sensitivity is estimated based on the incidence of sensitization. Sensitivity incidence = (Number of animals with allergic reactions / Total number of animals) × 100%. Sensitivity incidence (%): 0-10 indicates no sensitization, 11-30 indicates mild sensitization, 31-60 indicates moderate sensitization, 61-80 indicates severe sensitization, and 81-100 indicates extreme sensitization.

[0098] The experimental results showed that no systemic allergic reactions such as erythema, edema, respiratory distress, or abnormal activity were observed on the local skin of guinea pigs in the herbal composition cream group and the blank control group, with a sensitization rate of 0. In the positive control group, guinea pigs were observed and recorded immediately, at 24h, 48h, 72h, 7d, and 14d after challenge exposure to the drug. The average allergy scores were 1.67±0.52, 1.17±0.41, 1±0.63, 0.5±0.55, 0.33±0.52, and 0.17±0.41, respectively, with a sensitization rate of 100%.

[0099] The results are shown in Table 6:

[0100] Table 6

[0101]

[0102] In summary, this invention successfully prepared a traditional Chinese medicine composition cream and conducted a treatment study on guinea pig tinea corporis based on an animal model of tinea corporis. The study found that its therapeutic effect was significant and superior to the positive control drug. Acute skin toxicity, skin irritation, and skin allergy tests were also conducted, and the results all indicated that the traditional Chinese medicine composition cream was non-toxic, non-irritating, and non-allergenic to skin tissue. This invention provides a basis for the treatment of tinea corporis with traditional Chinese medicine compound topical preparations.

[0103] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-described technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes, and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating tinea, characterized in that, It is made from the following components in parts by weight: Sophora flavescens 20-40 parts, Stemona japonica 10-20 parts, Hibiscus syriacus bark 10-20 parts, Euphorbia fischeriana 10-40 parts, Buthus martensii 3-12 parts, Pseudolarix amabilis bark 20-40 parts, Phellodendron chinense bark 20-40 parts, Dictamnus dasycarpus bark 20-40 parts, Cnidium monnieri 20-40 parts, Vespa nidus 10-20 parts, Zanthoxylum bungeanum 10-20 parts, Gallus gallus domesticus gizzard lining 10-20 parts.

2. The traditional Chinese medicine composition for treating tinea according to claim 1, characterized in that, The traditional Chinese medicine composition for treating tinea is made from the following components in parts by weight: 30 parts Sophora flavescens, 15 parts Stemona japonica, 15 parts Hibiscus syriacus bark, 15 parts Euphorbia fischeriana, 6 parts Buthus martensii, 30 parts Pseudolarix amabilis bark, 30 parts Phellodendron chinense bark, 30 parts Dictamnus dasycarpus bark, 30 parts Cnidium monnieri, 15 parts Vespa nidus, 15 parts Zanthoxylum bungeanum, and 15 parts Gallus gallus domesticus gizzard lining.

3. The traditional Chinese medicine composition for treating tinea according to claim 1, characterized in that, The traditional Chinese medicine composition for treating tinea is made from the following components in parts by weight: 20 parts Sophora flavescens, 10 parts Stemona japonica, 10 parts Hibiscus syriacus bark, 10 parts Euphorbia fischeriana, 3 parts Buthus martensii, 20 parts Pseudolarix amabilis bark, 20 parts Phellodendron chinense bark, 20 parts Dictamnus dasycarpus bark, 20 parts Cnidium monnieri, 10 parts Vespa nidus, 10 parts Zanthoxylum bungeanum, and 10 parts Gallus gallus domesticus gizzard lining.

4. The traditional Chinese medicine composition for treating tinea according to claim 1, characterized in that, The traditional Chinese medicine composition for treating tinea is made from the following components in parts by weight: 40 parts Sophora flavescens, 20 parts Stemona japonica, 20 parts Hibiscus syriacus bark, 40 parts Euphorbia fischeriana, 12 parts Buthus martensii, 40 parts Pseudolarix amabilis bark, 40 parts Phellodendron chinense bark, 40 parts Dictamnus dasycarpus bark, 40 parts Cnidium monnieri, 20 parts Vespa nidus, 20 parts Zanthoxylum bungeanum, and 20 parts Gallus gallus domesticus gizzard lining.

5. The use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for treating tinea.

6. A traditional Chinese medicine preparation made from the traditional Chinese medicine composition according to any one of claims 1 to 4.

7. The traditional Chinese medicine preparation according to claim 6, characterized in that, The dosage form of the traditional Chinese medicine preparation is a cream.

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