Traditional Chinese medicine composition for treating seborrheic dermatitis and alopecia and use thereof

Abstract

The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating seborrheic dermatitis and alopecia and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Sophora flavescens 9-11 parts, Phellodendron chinense 9-11 parts, Paris polyphylla 4-6 parts, Lotus leaf 9-11 parts, Fructus Kochiae 14-16 parts, Dictamnus dasycarpus 14-16 parts, Mentha haplocalyx 9-11 parts, and Salvia miltiorrhiza 19-21 parts. The traditional Chinese medicine composition has a good therapeutic effect on treating seborrheic dermatitis and alopecia, can improve the pathological state of skin, improve hair growth, and has a good application prospect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition for treating seborrheic dermatitis and hair loss and its uses. Background Technology

[0002] Seborrheic dermatitis and hair loss are common chronic hair and skin diseases in clinical practice. Both are closely related to local sebaceous gland hypersecretion, abnormal androgen levels, and inflammatory response of the hair follicle microenvironment in terms of pathogenesis. They often occur together and seriously affect the patient's quality of life.

[0003] Current routine clinical treatments mainly include: topical antifungal agents (such as ketoconazole), corticosteroids, calcineurin inhibitors, and oral anti-androgen drugs (such as finasteride) and immunomodulators. While these medications have some efficacy, they also have several limitations: topical medications can easily lead to local skin irritation, atrophy, and drug resistance; oral anti-androgen drugs may cause systemic adverse reactions such as sexual dysfunction and gynecomastia; and the safety and adherence to long-term medication are not ideal. Furthermore, existing treatment regimens have limited effectiveness in improving the inflammatory microenvironment of hair follicles associated with seborrheic dermatitis, making it difficult to simultaneously achieve comprehensive effects such as oil control, anti-inflammation, anti-androgen therapy, and hair growth promotion.

[0004] Traditional Chinese medicine (TCM) offers unique advantages in treating these diseases through holistic regulation and multi-target intervention. Traditional Chinese medicine formulas are often based on principles such as "clearing heat and drying dampness, cooling blood and detoxifying, and dispelling wind and relieving itching," as exemplified by classic formulas like the "Wind-Dispelling and Muscle-Changing Powder" recorded in the *Yizong Jinjian*. In recent years, there have been reports of using single herbs or compound formulas such as *Sophora flavescens*, *Dictamnus dasycarpus*, and *Platycladus orientalis* for external treatment of seborrheic dermatitis, achieving certain clinical results. However, existing TCM preparations are mostly empirical formulas, and there is still a need to optimize the formulation of TCM combinations to achieve better therapeutic effects for seborrheic dermatitis and hair loss. Summary of the Invention

[0005] In view of the problems of the prior art, the present invention provides a traditional Chinese medicine composition for treating seborrheic dermatitis and hair loss and its uses.

[0006] A traditional Chinese medicine composition is made from the following raw materials in parts by weight: 9-11 parts Sophora flavescens, 9-11 parts Phellodendron chinense, 4-6 parts Paris polyphylla, 9-11 parts Nelumbo nucifera, 14-16 parts Kochia scoparia, 14-16 parts Dictamnus dasycarpus, 9-11 parts Mentha haplocalyx, and 19-21 parts Salvia miltiorrhiza.

[0007] Preferably, it is made from the following raw materials in parts by weight: 10 parts Sophora flavescens, 10 parts Phellodendron chinense, 5 parts Paris polyphylla, 10 parts Nelumbo nucifera, 15 parts Kochia scoparia, 15 parts Dictamnus dasycarpus, 10 parts Mentha haplocalyx, and 20 parts Salvia miltiorrhiza.

[0008] Preferably, it is a formulation prepared by adding pharmaceutically acceptable excipients or auxiliary ingredients to the active ingredient, which is the original drug of the raw material, water or organic solvent extract.

[0009] Preferably, the preparation is a topical preparation.

[0010] Preferably, the preparation is an ointment, cream, gel, liniment, lotion, tincture, plaster, patch, paste, powder, coating, film, aerosol, spray, or foam.

[0011] Preferably, the traditional Chinese medicine composition is used to treat seborrheic dermatitis and / or androgenetic alopecia.

[0012] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating seborrheic dermatitis.

[0013] Preferably, the drug is used to reduce fungal infections on the skin surface and to reduce epidermal thickening and inflammatory cell infiltration.

[0014] The present invention also provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for treating hair loss.

[0015] Preferably, the type of hair loss is androgenetic alopecia; and / or, the drug is used to increase the number of hair follicles in the skin tissue.

[0016] I. Solutions for Hair Loss After the prescription was changed to be applied externally, its core mechanism of action changed to directly acting on the local microenvironment of the scalp. Through transdermal absorption, it exerts the effects of clearing heat and dampness, dispelling wind and relieving itching, and promoting blood circulation and unblocking collaterals. This aligns with the pathogenesis of hair loss scalp, which involves "damp-heat accumulation, blood stasis obstructing the hair follicles, and wind-dryness causing malnourishment." The external application formula is explained as follows: Sophora flavescens: It tastes bitter and is cold in nature. It enters the heart, liver, stomach, large intestine and bladder meridians. It is the chief herb. It is good at clearing heat and drying dampness, killing parasites and relieving itching. Its nature is descending. It can clear damp heat in the internal organs and skin, and at the same time relieve the inflammatory state of the scalp microenvironment. Phellodendron bark: It tastes bitter and is cold in nature. It enters the kidney, bladder and large intestine meridians. It is an assistant herb and is good at clearing heat and drying dampness, purging fire and detoxifying. It is especially good at clearing damp heat in the lower burner. It can also strengthen yin and prevent bitter and cold herbs from damaging yin and consuming fluids. When combined with Sophora flavescens, it forms a pattern of clearing heat and removing dampness by treating both the upper and lower parts of the body, reducing scalp oil secretion and improving the living environment of hair follicles. Paris polyphylla: It tastes bitter and is slightly cold in nature. It is used as an assistant herb and enters the liver meridian. Its functions are to clear heat and detoxify, reduce swelling and dissipate nodules. When used in a light dose (5 parts), it can clear the deep heat toxins in the scalp and relieve the potential inflammatory nodules in the hair follicles. At the same time, its slightly cold nature will not make it too cold. Kochia scoparia fruit: pungent and bitter in taste, cold in nature, enters the kidney and bladder meridians, serving as an adjuvant herb. Its core functions are clearing heat and dampness, dispelling wind and relieving itching. It can clear damp-heat in the lower burner and on the skin surface, and also disperse wind-evil from the skin. Targeting symptoms of damp-heat and wind-dryness such as oily scalp and itching, it relieves damp-heat stagnation around the hair follicles from the source, making it an essential medicine for treating dermatological itching and malnourishment of hair.

[0017] Dictamnus dasycarpus root bark: Bitter in taste and cold in nature, it enters the spleen, stomach, and bladder meridians. As an adjuvant herb, it excels at clearing heat and drying dampness, dispelling wind and detoxifying. Its drying power is strong, which can clear deep damp heat in the skin, and it can also dispel wind and unblock the meridians, improving stagnation of qi and blood in the scalp. When used in combination with Kochia scoparia fruit, it strengthens the core effects of "clearing heat and removing dampness, dispelling wind and relieving itching", directly targeting the symptoms of hair loss.

[0018] Danshen (Salvia miltiorrhiza): Bitter in taste and slightly cold in nature, it enters the heart and liver meridians. As an adjuvant herb, it is a key herb for "invigorating blood and nourishing blood," used in doses of up to 20 parts. In the formula, it plays the role of "invigorating blood and unblocking collaterals, nourishing blood and promoting hair growth." On the one hand, Danshen can remove blood stasis and unblock collaterals, improve scalp microcirculation, and break through the pathogenesis of "blood stasis obstructing the flow of new blood to the hair roots." On the other hand, its blood-nourishing function can nourish the hair, taking into account "removing blood stasis without harming the body's vital energy, and invigorating blood to generate new blood," laying the material foundation for hair regeneration. At the same time, it balances the bitter and cold nature of the principal and assistant herbs, preventing them from damaging blood and depleting qi.

[0019] Lotus leaf: It tastes bitter and astringent, is neutral in nature, and enters the liver, spleen, and stomach meridians. As an adjuvant, it can clear summer heat and dampness, and promote the upward movement of clear yang. Its "upward movement of clear yang" can guide the medicine to the top of the head, while clearing dampness without harming yin. It can improve the state of clear yang not rising in the head and dampness obscuring the orifices, and promote the upward movement of qi, blood and body fluids to nourish the hair. Peppermint: It has a pungent taste and cool nature, and enters the lung and liver meridians. As an adjuvant, it can dispel wind-heat, clear the head and eyes, and promote rash eruption and relieve itching. Its pungent and cool nature can not only dispel wind-dryness of the scalp and relieve itching and dandruff, but also act as a "guiding herb" to direct all the medicines in the formula directly to the affected area (scalp). At the same time, its light and clear nature can prevent the bitter, cold, and blood-activating medicines in the formula from becoming too stagnant.

[0020] Characteristics of the whole formula 1. Local targeting, directly to the affected area: The drug does not pass through the internal organs for metabolism, but acts directly on the scalp and hair follicles. It has a fast effect and avoids the harm to the spleen and stomach caused by taking bitter and cold medicines. It is especially suitable for patients with weak spleen and stomach but obvious damp heat stagnation on the scalp. 2. Layered action, addressing both symptoms and root cause: From the surface (oil control and itch relief), superficial layer (anti-inflammatory and antibacterial) to the deep layer (blood circulation and follicle nourishment), a complete action system is formed, which not only improves immediate symptoms but also promotes hair follicle repair; 3. Harmonious medicinal properties, safe and controllable: By nourishing blood with danshen, protecting the scalp with lotus leaf, and penetrating with peppermint, the irritation of bitter and cold medicines is balanced, reducing the risk of damage to the scalp barrier, making it suitable for long-term external use.

[0021] II. Treatment for Seborrheic Dermatitis In Traditional Chinese Medicine (TCM), seborrheic dermatitis is often classified as "facial wind" or "white dandruff wind." Its core pathogenesis involves spleen and stomach dysfunction, leading to internal damp-heat, which ascends to the head and face along the meridians, accompanied by wind-evil, obstructing the pores. Symptoms include oily scalp / face, itching, and scaling. This external application targets the core pathogenesis of "damp-heat accumulation in the skin, wind-evil disturbance, and blood stasis obstructing the meridians," using the core treatment principles of clearing heat and drying dampness, dispelling wind and relieving itching, and promoting blood circulation and unblocking the meridians. It directly reaches the affected area through local transdermal action. The specific formula is explained below: Seborrheic dermatitis lesions are concentrated on the surface of the skin and around the hair follicles. Topical application allows the active ingredients of the drug to act directly on the affected area, avoiding the impact of oral medications on internal organs and quickly improving the local microenvironment—removing excess oil, inhibiting inflammatory reactions, relieving itching and scaling, and repairing the skin barrier. This aligns with the traditional Chinese medicine principle of "treating external diseases externally and addressing both the symptoms and the root cause."

[0022] Sophora flavescens: Bitter in taste and cold in nature, it enters the heart, liver, and bladder meridians, serving as the principal herb. When applied externally, it can directly reach the skin surface. Its core functions are clearing heat and drying dampness, killing parasites and inhibiting bacteria, and relieving itching. Its components, such as matrine, can directly inhibit excessive sebum secretion, reducing scalp and facial oiliness. It also has a significant inhibitory effect on pathogenic bacteria related to seborrheic dermatitis, such as Malassezia, and can alleviate local inflammatory edema and itching, thus addressing the core pathogenesis of "damp-heat accumulating in the skin" at its source.

[0023] Phellodendron bark: Bitter and cold in nature, it enters the kidney and bladder meridians. As an assistant herb, it is effective in clearing heat and drying dampness, purging fire and detoxifying, and astringing and relieving itching when used externally. Its berberine component can enhance the antibacterial and anti-inflammatory effects, clearing away damp-heat toxins deep in the skin. At the same time, it also has astringent properties, which can reduce skin exudation and relieve stickiness and discomfort. When used in conjunction with Sophora flavescens, it forms a synergistic effect of "controlling oil on the surface, removing dampness deep inside, and anti-inflammatory throughout the treatment", which is the core pillar of the whole formula for treating seborrheic dermatitis.

[0024] Paris polyphylla: Bitter in taste and slightly cold in nature, it enters the liver meridian. For external use, the dosage is small (5 parts), serving as an assistant herb. Its functions are clearing heat and detoxifying, reducing swelling and dissipating nodules. For the small inflammatory nodules or pustules that may appear in the hair follicles during the course of seborrheic dermatitis, Paris polyphylla can clear deep heat toxins, prevent the spread of inflammation, and its mild medicinal properties do not irritate the skin. It assists the principal herb in clearing residual pathogens and consolidating the anti-inflammatory effect.

[0025] Kochia scoparia: It has a pungent and bitter taste, and is cold in nature. It enters the kidney and bladder meridians and is used as an adjuvant medicine. When used externally, it is good at clearing away damp heat in the skin and dispersing wind-evil from the surface of the skin. Its pungent and dispersing properties can penetrate into the skin meridians and relieve itching caused by "wind-evil disturbance". Its bitter and cold properties can clear away residual damp heat. Moreover, its medicinal properties are mild. While relieving itching, it does not damage the skin barrier. It is especially suitable for seborrheic dermatitis with obvious itching and desquamation.

[0026] Dictamnus dasycarpus root bark: Bitter and cold in nature, it enters the spleen and stomach meridians. As an adjuvant herb, its external effects are clearing heat and drying dampness, dispelling wind and detoxifying, and moisturizing and relieving itching. It can clear deep-seated damp-toxins in the skin and improve inflammatory infiltration around hair follicles. It can also relieve skin tightness and itching by dispelling wind and unblocking the meridians. At the same time, it has a certain repairing effect on damaged skin barrier. When combined with Kochia scoparia fruit, it strengthens the effect of "dispelling wind and relieving itching", solves the core subjective symptoms of seborrheic dermatitis, and assists the principal herb in consolidating the effect of clearing heat and removing dampness.

[0027] Danshen (Salvia miltiorrhiza): Bitter in taste and slightly cold in nature, it enters the heart and liver meridians. When used externally, it is the key to "invigorating blood and protecting the skin" in the formula. As an adjuvant, its components such as tanshinone can penetrate the stratum corneum of the skin, improve local microcirculation, break up skin metabolic disorders caused by "stasis and obstruction," and promote the repair of damaged skin tissue. At the same time, its blood-nourishing properties can nourish the skin, balance the bitter and cold properties of the principal and assistant herbs, and avoid excessive drying and dampness that could lead to increased skin dryness and peeling, thus achieving "invigorating blood without depleting blood, and clearing the meridians to nourish the skin."

[0028] Lotus leaf: It tastes bitter and astringent and is neutral in nature. It enters the liver and spleen meridians. When used externally, it can resolve dampness and promote the upward movement of clear qi, and guide the medicine upward. As a guiding medicine, its light and clear nature can guide the effective ingredients of the whole formula to gather in the areas where seborrheic dermatitis often occurs, such as the head and face. At the same time, it resolves dampness without causing dryness, avoiding dryness and discomfort of the scalp / face due to drug stimulation. It can also improve the local state of insufficient clear yang and stagnation of dampness and turbidity, and help regulate skin metabolism.

[0029] Peppermint: It has a pungent and cool nature, and enters the lung and liver meridians. When used externally, it is the core "guiding medicine" and "harmonizing medicine". As an adjuvant, its pungent and cool nature can quickly penetrate the skin, promote the transdermal absorption of other drug components, and at the same time disperse wind-heat on the skin surface, clear the head and eyes, and relieve the burning and itching sensation of the skin. In addition, the cooling nature of peppermint can neutralize the stagnant nature of bitter and cold medicines in the formula, so that the medicinal power can penetrate without stagnation, and improve the overall efficacy.

[0030] External application compatibility characteristics 1. Targeted and precise: The medication acts directly on the affected skin, with rapid onset and strong targeting, making it especially suitable for seborrheic dermatitis limited to the scalp and face; 2. Layered treatment: A complete chain of action is formed from "oil control and dampness drying (surface layer) → anti-inflammatory and antibacterial (superficial layer) → blood circulation promotion and repair (deep layer) → wind removal and itch relief (symptoms)", which takes into account both immediate relief and long-term conditioning; 3. Mild medicinal properties: Through the blood-nourishing properties of Danshen, the protective properties of lotus leaf, and the harmonizing properties of peppermint, the irritation of bitter and cold medicines is balanced, reducing the risk of skin barrier damage, making it suitable for long-term external use.

[0031] This formula closely addresses the local pathogenesis of seborrheic dermatitis, namely "dampness and heat, wind and stagnation," and achieves the unity of "clearing, drying, unblocking and nourishing" through external application, providing a combination of efficacy and safety for the external treatment of seborrheic dermatitis.

[0032] This invention provides a novel traditional Chinese medicine composition that exhibits excellent therapeutic effects on seborrheic dermatitis and alopecia, improving skin pathology and hair growth in animal models. Furthermore, the formulation of this traditional Chinese medicine composition has been optimized, resulting in significantly superior therapeutic effects compared to several similar formulations. Therefore, the traditional Chinese medicine composition of this invention has promising application prospects.

[0033] Obviously, based on the above description of the present invention, and according to common technical knowledge and conventional methods in the field, various other modifications, substitutions or alterations can be made without departing from the basic technical concept of the present invention.

[0034] The following detailed embodiments further illustrate the above-described content of the present invention. However, this should not be construed as limiting the scope of the present invention to the following examples. All technologies implemented based on the above-described content of the present invention fall within the scope of the present invention. Attached Figure Description

[0035] Figure 1 Images showing the hair loss status of mice in each group in Experiment Example 1; Figure 2 The images show the pathological morphological results of mice in each group in Experiment Example 1. A is the image of group C (×200), B is the image of group Mo (×200), C is the image of the whole prescription group (×200), D is the image of prescription 1 (×200), E is the image of prescription 2 (×200), F is the image of prescription 3 (×200), and G is the image of prescription 4 (×200). Figure 3 The table below shows the statistical results of the number of hair follicles in the skin tissue of mice in each group after drug administration in Experiment 1. A represents the comparative experimental results of group C, group Mo, the whole formula group, group 1 (fragmented formula), and group 2 (fragmented formula); B represents the comparative experimental results of group C, group Mo, the whole formula group, group 3 (fragmented formula), and group 4 (fragmented formula). " indicates P < 0.05; Figure 4 Images showing fungal infections in mice from each group in Experiment Example 2; Figure 5 The images show the pathological morphological results of mice in each group in Experiment Example 2. Among them, A is the image of group C (×40), B is the image of group C (×200), C is the image of group Mo (×40), D is the image of group Mo (×200), E is the image of the whole formula group (×40), F is the image of the whole formula group (×200), G is the image of the split formula group 1 (×40), and H is the image of the split formula group 1 (×200). Figure 6The images show the pathological morphological results of mice in each group in Experiment Example 2. Among them, A is the image of group 2 (×40), B is the image of group 2 (×200), C is the image of group 3 (×40), D is the image of group 3 (×200), E is the image of group 4 (×40), and F is the image of group 4 (×200).

[0036] Figure 7 This is a schematic diagram of the NRS numerical rating scale and greasiness rating scale in Experiment Example 3; Figure 8 This is a schematic diagram of the scoring locations and scoring table for the scaling index in Experiment Example 3; Figure 9 This is a bar chart showing the results of the pruritus index assessment in Experiment Example 3; Figure 10 This is a bar chart showing the results of the greasiness index examination in Experiment Example 3; Figure 11 This is a bar chart showing the results of the scale index examination in Experiment Example 3; Figure 12 This is a bar chart showing the results of the hair growth index examination in Experiment Example 3. Detailed Implementation

[0037] In the following examples and experimental cases, reagents and raw materials not specifically described are all commercially available products.

[0038] Example 1 The traditional Chinese medicine composition in this embodiment is as follows: Sophora flavescens 10g, Phellodendron chinense 10g, Paris polyphylla 5g, Nelumbo nucifera leaf 10g, Kochia scoparia 15g, Dictamnus dasycarpus 15g, Mentha haplocalyx 10g, Salvia miltiorrhiza 20g.

[0039] The preparation of the traditional Chinese medicine composition in this embodiment is as follows: Soak the above-mentioned herbs in cold water for 0.5 hours, decoct 3 times, add 6 times the amount of water each time and decoct for 45 minutes, filter through a 140-mesh sieve, concentrate the filtrate to 400ml, add 4g of sorbic acid as a preservative, mix well, and dispense into 100ml bottles.

[0040] In other embodiments, the formulation of the traditional Chinese medicine composition may also be varied within the following ranges: Sophora flavescens 9-11 g, Phellodendron chinense 9-11 g, Paris polyphylla 4-6 g, Nelumbo nucifera leaf 9-11 g, Kochia scoparia 14-16 g, Dictamnus dasycarpus 14-16 g, Mentha haplocalyx 9-11 g, Salvia miltiorrhiza 19-21 g; For example: Sophora flavescens 9 g, Phellodendron chinense 11 g, Paris polyphylla 4 g, Nelumbo nucifera leaf 11 g, Kochia scoparia 14 g, Dictamnus dasycarpus 16 g, Mentha haplocalyx 9 g, Salvia miltiorrhiza 21 g; Alternatively, use 11 g of Sophora flavescens, 9 g of Phellodendron chinense, 6 g of Paris polyphylla, 9 g of Nelumbo nucifera leaf, 16 g of Kochia scoparia, 14 g of Dictamnus dasycarpus root bark, 11 g of Mentha haplocalyx, and 19 g of Salvia miltiorrhiza.

[0041] For seborrheic dermatitis and hair loss, these modified formulations can achieve therapeutic effects comparable to those in this embodiment.

[0042] Comparative Example 1 This comparative example provides several comparative traditional Chinese medicine compositions (formulas 1-4), and the differences between the formulations of these comparative traditional Chinese medicine compositions and those of Example 1 are as follows: Table 1 The comparative Chinese herbal compositions in this example were all prepared into formulations using the same method as in Example 1, and were used for subsequent comparative experimental studies.

[0043] The technical solution of the present invention will be further illustrated by the following experiments. The whole or split Chinese herbal medicine compositions used in the following experiments were prepared according to the method described in Example 1 or Comparative Example 1.

[0044] Experimental Example 1: Study on the Treatment of Hair Loss in C57 Mice I. Experimental Methods 1. Laboratory animals and their housing environment C57 mice, SPF grade, 21 males, weighing 17.6~19.8g. Provided by Chengdu Yaokang Biotechnology Co., Ltd., Laboratory Animal Production License No.: SCXK (Sichuan) 2020-0034.

[0045] Environment: Barrier environment, temperature 20-26℃, relative humidity 30-70%, 12h / 12h day / night light / dark cycle. Laboratory animal use license number: SYXK (Sichuan) 2025-0225.

[0046] Feed: Complete feed.

[0047] Drinking water: Sterile water is placed in the water box for the animals to drink freely.

[0048] 2. Method 2.1 Dihydrotestosterone intraperitoneal injection induced alopecia-like hair loss in mice Eighteen mice were injected intraperitoneally with 0.5 ml of dihydrotestosterone (DHT, 1 mg / ml) after hair removal. On the fourth day after the injection, the backs of 21 mice were shaved and then depilatory cream was applied to remove the hair, leaving the back skin completely bare. The hair removal area was approximately 2 × 2 cm. After the hair removal was completed, the 18 mice that received the DHT injection were injected intraperitoneally with 0.5 ml of DHT (1 mg / ml) twice a week for two consecutive weeks.

[0049] 2.2 Animal grouping Three mice that did not develop the model were used as the normal control group, and 18 mice injected with DHT were randomly divided into the following groups: Normal control group (Control group, C): 3 animals.

[0050] Model control group (Mo): 3 animals.

[0051] All-round group (QF group, QF): 3 animals.

[0052] Dismantle Group 1 (CF1 Group, CF1): 3 units.

[0053] Two groups of CF2 (CF2 group): 3 animals.

[0054] Disassemble 3 groups (CF3 group, CF3): 3 units.

[0055] Disassemble 4 groups (CF4 group, CF4): 3 units.

[0056] 2.3 Sample Dosage and Treatment Course Normal control group: 2ml of normal saline was applied once a day for 14 consecutive days.

[0057] Model control group: 2ml of physiological saline was applied once a day for 14 consecutive days.

[0058] Full-formula group: Apply 2ml of the full-formula medicine solution once a day for 14 consecutive days.

[0059] Formula 1: Apply 2ml of the medicine solution from Formula 1 once a day for 14 consecutive days.

[0060] Formula 2: Apply 2ml of the medicine solution from Formula 2 once a day for 14 consecutive days.

[0061] Formula 3: Apply 2ml of the medicine solution from Formula 3 once a day for 14 consecutive days.

[0062] Formula 4: Apply 2ml of the medicine solution from Formula 4 once a day for 14 consecutive days.

[0063] Mice in each group were given different samples according to Table 2. The application of the sample to mice in each group began on the 4th day after DHT injection.

[0064] During the experiment, mice in each group had free access to water.

[0065] Table 2 Dosage of Animal Samples 2.4 Observation Indicators 2.4.2 Observation of skin lesions After the administration of the drug, observe the hair growth of each mouse, take photos and record the data.

[0066] 2.4.3 HE staining to observe pathological morphological changes The tissue from the hair removal area was fixed, dehydrated, embedded in paraffin, sectioned, and stained with hematoxylin and eosin (HE). The pathological condition of the skin lesion was observed under a microscope and photographed for record-keeping.

[0067] II. Experimental Results 1. Results of hair growth observation like Figure 1 As shown, compared with group C, the hair in group Mo was significantly duller and sparser. Compared with group C, the hair in the full-formula group was significantly denser and shinier; the hair growth in group 1 (removed formula 1) was improved, and the fur was denser; the hair growth in group 2 (removed formula 2) was improved, and the fur was denser.

[0068] Compared to Group Mo, the full-strength group had significantly thicker and shinier hair; Group 3 showed improved hair growth and thicker fur; Group 4 showed improved hair growth and thicker fur.

[0069] 2. Pathological morphological examination results like Figure 2 , Figure 3 As shown in the HE staining results, compared with group C, group Mo showed obvious pathological changes; the number of hair follicles in the skin tissue was significantly reduced. Compared with group Mo, the full-formula group showed significant improvement in the severity of the lesions and a significant increase in the number of hair follicles in the skin tissue; group 1 (disassembled formula) showed some improvement in the severity of the lesions and a slight increase in the number of hair follicles in the skin tissue; group 2 (disassembled formula) showed significant improvement in the severity of the lesions and a significant increase in the number of hair follicles in the skin tissue. The degree of improvement in the full-formula group was significantly better than that in groups 1 and 2 (disassembled formula).

[0070] Compared with the Mo group, the full-formula group showed a significant improvement in the severity of lesions and a significant increase in the number of hair follicles in the skin tissue; the lesion severity in the split-formula group 3 showed some improvement and an increase in the number of hair follicles in the skin tissue; the lesion severity in the split-formula group 4 showed some improvement and an increase in the number of hair follicles in the skin tissue. The improvement in the full-formula group was significantly better than that in the split-formula groups 3 and 4.

[0071] Based on the results of this study, compared with the normal control group, the model control group mice showed a significant decrease in hair growth; compared with the model control group, the mice treated with the full formula showed a significant increase in hair growth, and the mice treated with formula 2 and formula 1 also showed hair growth, although the degree of growth was less than that of the full formula group; the mice treated with formula 3 and formula 4 also showed hair growth, although the degree of hair growth was less than that of the full formula group. Therefore, the traditional Chinese medicine composition of this invention has a good therapeutic effect on hair loss, and is significantly superior to the four formula groups.

[0072] Experimental Example 2: Experimental Study on the Treatment of Seborrheic Dermatitis in Guinea Pigs I. Experimental Methods 1. Laboratory animals and their housing environment Guinea pigs, standard grade, 21 males, weighing 304.5~368.2g. Provided by the Sichuan Provincial Laboratory Animal Committee Breeding Farm, Laboratory Animal Production License No.: SCXK (Sichuan) 2021-0037.

[0073] Environment: Normal environment, temperature 20-26℃, relative humidity 30-70%, 12h / 12h day / night light / dark cycle. Laboratory animal use license number: SYXK (Sichuan) 2025-0225.

[0074] Feed: Complete feed.

[0075] Drinking water: Sterile water is placed in the water box for the animals to drink freely.

[0076] 2. Method 2.1 Guinea pig seborrheic dermatitis model induced by application of Malassezia globosa Twenty-one guinea pigs had their backs shaved, followed by the application of depilatory cream to completely expose the skin. The depilated area was approximately 3×3 cm. After depilation, 18 of the guinea pigs were gently and evenly rubbed with sandpaper 24 hours later, ensuring no bleeding occurred. A bacterial suspension (1×10⁻⁶) was then collected. 8 Apply 100 μL (CFU / mL) evenly to the hairless area of ​​the back. Apply the bacteria once a day for 7 consecutive days, until obvious scaling appears on the skin of the back.

[0077] 2.2 Animal grouping Three unmodeled guinea pigs were used as the normal control group, and 18 successfully modeled guinea pigs were randomly divided into the following groups: Normal control group (Control group, C): 3 animals.

[0078] Model control group (Mo): 3 animals.

[0079] All-round group (QF group, QF): 3 animals.

[0080] Dismantle Group 1 (CF1 Group, CF1): 3 units.

[0081] Two groups of CF2 (CF2 group): 3 animals.

[0082] Disassemble 3 groups (CF3 group, CF3): 3 units.

[0083] Disassemble 4 groups (CF4 group, CF4): 3 units.

[0084] 2.3 Sample Dosage and Treatment Course Normal control group: 4ml of normal saline was applied once a day for 7 consecutive days.

[0085] Model control group: 4ml of physiological saline was applied once a day for 7 consecutive days.

[0086] Full-formula group: Apply 4ml of the full-formula medicine solution once a day for 7 consecutive days.

[0087] Formula 1: Apply 4ml of the medicine solution from Formula 1 once a day for 7 consecutive days.

[0088] Formula 2: Apply 4ml of the medicine solution from Formula 2 once a day for 7 consecutive days.

[0089] Formula 3: Apply 4ml of the medicine solution from Formula 3 once a day for 7 consecutive days.

[0090] Formula 4: Apply 4ml of the medicine solution from Formula 4 once a day for 7 consecutive days.

[0091] Each group of guinea pigs was given different sample materials according to Table 3. The application of materials began after the modeling was completed.

[0092] During the experiment, the guinea pigs in each group had free access to water.

[0093] Table 3 Dosage of Animal Samples 2.4 Observation Indicators 2.4.2 Observation of skin lesions After modeling and administration, observe the fungal infection status of each guinea pig, take photos and record them.

[0094] 2.4.3 HE staining to observe pathological morphological changes The tissue from the lesion site was fixed, dehydrated, embedded in paraffin, sectioned, and stained with hematoxylin and eosin (HE). The pathological condition of the lesion tissue was observed under a microscope and photographed for record-keeping.

[0095] II. Experimental Results 1. Observation results of fungal infection like Figure 4 As shown, after modeling, compared with group C, group Mo showed obvious fungal infection.

[0096] After administration, compared with group C, group Mo showed obvious fungal infection. Compared with group Mo, the fungal infection in the whole formula group showed significant improvement; the fungal infection in the split formula 1 group showed no significant improvement; and the fungal infection in the split formula 2 group showed some improvement.

[0097] Compared with the Mo group, the fungal infection in the whole formula group was significantly improved; the fungal infection in the split formula group 3 was improved; and the fungal infection in the split formula group 4 was improved.

[0098] 2. Pathological morphological examination results like Figure 5 , Figure 6As shown, HE staining results revealed that, compared to group C, group Mo exhibited significant pathological changes; epidermal thickening, dermal collagen fiber necrosis, a small amount of inflammatory cell infiltration, formation of new capillaries, and fibrous tissue proliferation were observed. Compared to group Mo, the full-formula group showed a significant improvement in lesion severity, with some epidermal thickening and a very small amount of inflammatory cell infiltration; the severity of lesions in group 1 (split formula) was not significantly different, with epidermal thickening, dermal collagen fiber necrosis, a small amount of inflammatory cell infiltration, and fibrous tissue proliferation; the severity of lesions in group 2 (split formula) was somewhat reduced, with epidermal thickening, dermal collagen fiber necrosis, and fibrous tissue proliferation.

[0099] Compared with the Mo group, the full-formula group showed a significant improvement in the severity of lesions, with some thickening of the epidermis and a very small amount of inflammatory cell infiltration. The severity of lesions in the split-formula groups 3 and 4 was not significantly different, with thickening of the epidermis, necrosis of collagen fibers in the dermis, a small amount of inflammatory cell infiltration, and proliferation of fibrous tissue.

[0100] Based on the results of this study, compared with the normal control group, the fungal infection rate of the model control group was significantly upregulated. Compared with the model control group, the fungal infection rate of the skin in guinea pigs treated with the full formula was significantly reduced. The fungal infection rate of the skin in guinea pigs treated with formula 2 and formula 1 was also reduced, but the degree of reduction was not as great as that in the full formula group. The fungal infection rate of the skin in guinea pigs treated with formula 3 and formula 4 was also reduced, but the degree of reduction was not as great as that in the full formula group. It can be seen that the traditional Chinese medicine composition of the present invention has a good therapeutic effect on seborrheic dermatitis, and is significantly better than the four formula groups.

[0101] Groups 2 and 1 of the formula were based on the whole formula, with adjustments made to the dosage of Sophora flavescens. The experimental results of Examples 1 and 2 above show that the dosage of Sophora flavescens in the formula of this invention is the optimal choice, achieving the best therapeutic effect. Group 3 was based on the whole formula, with "Phellodendron amurense 10g, Paris polyphylla 5g" replaced by "Phellodendron amurense 15g". Group 4 was based on the whole formula, with "Phellodendron amurense 10g, Paris polyphylla 5g" replaced by "Paris polyphylla 15g". The experimental results show that the combined use of Phellodendron amurense and Paris polyphylla achieved significantly better therapeutic effects than either herb used alone, indicating that Phellodendron amurense and Paris polyphylla achieved a synergistic therapeutic effect in the drug formula of this invention.

[0102] Experimental Case 3: Clinical Study Results I. Experimental Methods 1. Sample Description The cases observed in this study were all patients with androgenetic alopecia who visited the Dermatology Clinic of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from November 2024 to November 2025. The number of patients required for each group was calculated. Considering the possibility of loss to follow-up, it was assumed that the overall loss to follow-up rate in this study was 10-20%. Therefore, a total of 180 × (1 + 15%) ≈ 208 patients were included in this study. In the collected cases, men mainly presented with a receding hairline and / or progressive thinning and reduction of hair in the parietal and occipital regions, also known as male pattern baldness (male pattern hair loss). In women, the main manifestation was progressive thinning and reduction of hair primarily on the top of the head, generally without a receding hairline, known as female pattern alopecia (female pattern hair loss). A small number of cases may involve the temporal region, or even diffuse involvement of the entire scalp.

[0103] 2. Experimental Grouping This experimental example includes the following four experimental groups: Group 0 is the selenium disulfide group: Drug brand name: Sylgen; Manufacturer: Jiangsu Disano Pharmaceutical Co., Ltd.; Approval number: Suyaozhizi Z04000103. Usage: Apply 10g each time to wet hair and scalp, massage the head for 10 minutes, then rinse with water. Use as an external treatment once every 3 days.

[0104] Group 1 is the experimental group of the traditional Chinese medicine composition of this invention (containing Paris polyphylla): The formula of the traditional Chinese medicine composition is as follows: 10g of Sophora flavescens, 10g of Phellodendron chinense, 5g of Paris polyphylla, 10g of Nelumbo nucifera leaf, 15g of Kochia scoparia, 15g of Dictamnus dasycarpus root bark, 10g of Mentha haplocalyx, and 20g of Salvia miltiorrhiza.

[0105] The preparation of the traditional Chinese medicine composition in this embodiment is as follows: Soak the above-mentioned herbs in cold water for 0.5 hours, decoct 3 times, add 6 times the amount of water each time and decoct for 45 minutes, filter through a 140-mesh sieve, concentrate the filtrate to 400ml, add 4g of sorbic acid as a preservative, mix well, and dispense into 100ml bottles.

[0106] How to use: Wet your hair and scalp with warm water at 35℃-40℃. Apply an appropriate amount (5-10ml) of shampoo evenly to your scalp. Massage the affected areas of hair loss and itching with your fingertips to promote absorption of the medication for 5 to 8 minutes. Then rinse thoroughly with clean water. Use 3 times a week for 14 days (4 weeks) as one course of treatment.

[0107] Group 2 is the group excluding Paris polyphylla: The formula of the traditional Chinese medicine composition is as follows: 10g of Sophora flavescens, 10g of Phellodendron chinense, 10g of Nelumbo nucifera leaf, 15g of Kochia scoparia, 15g of Dictamnus dasycarpus root bark, 10g of Mentha haplocalyx, and 20g of Salvia miltiorrhiza.

[0108] The preparation, storage and use of the drug solution are the same as in Group 1.

[0109] Group 3 consists of a single type of Paris polyphylla: Applicable Chinese herbal medicine: Paris polyphylla 5g.

[0110] The preparation, storage and use of the drug solution are the same as in Group 1.

[0111] 3. Evaluation of treatment effectiveness After treatment with the drugs and methods used in the four experimental groups (groups 0-3) described above, the following indicators were examined: (1) Itching index (NRS numerical rating scale), oiliness rating scale, Skindex-16 items Patients recorded the severity of itching and tolerance to oiliness at weeks 0, 2, 4, 8, and 12 of treatment. Itching severity was assessed using the NRS numerical rating scale, with 0 indicating no itching and 10 indicating extreme itching, graded into four levels. Oiliness tolerance was graded into five levels, with patients selecting a level based on their own hair oiliness during treatment, 0 indicating complete tolerance and 6 indicating extreme oiliness. Patients were asked to rate the level of their perceived intensity (e.g., ...). Figure 7 (As shown).

[0112] (2) Scale index The scalp was divided into eight areas: left forehead, left top, left occiput, left neck, right forehead, right top, right occiput, and right neck. No visible dandruff scored 0 points; occasional fine dandruff at the hair roots scored 1 point; visible fine dandruff at the hair roots scored 2 points; a small amount of large dandruff or a large amount of fine dandruff scored 3 points; a large amount of large dandruff scored 4 points. The score for scalp adhesion was calculated by summing the scores from all areas. Figure 8 As shown.

[0113] (3) Hair growth index Observation area: Based on the common hair loss sites of androgenetic alopecia, the forehead and crown were selected for observation at the Touwei and Baihui acupoints. The main observations were the total number of hairs, hair density, and hair shaft diameter variation rate before and after the hair loss. Hair count: Total number of hairs per field of view Hair density: Total number of hair shafts per square centimeter (total hair shafts / cm2) Hair shaft diameter variation rate: the ratio of vellus hair (diameter <30μm) to the total number of hair shafts.

[0114] II. Experimental Results The test results of various indicators at week 0 (i.e., before treatment), week 2, week 4, week 8, and week 12 of treatment are shown in Tables 4-7. Figures 9-12 As shown: Table 4. Results of analysis of pruritus indicators p <0.05 p <0.01 Table 5. Results of Oiliness Index Analysis p <0.05 p <0.01 Table 6. Results of Scalp Index Analysis p <0.05 p <0.01 Table 7. Results of Hair Growth Index Analysis p <0.05 p <0.01 To facilitate comparison of treatment effects among the experimental groups, the improvement values ​​of each indicator at week 12 relative to week 0 were calculated, and the results are shown in the table below: Table 8 Improvement of each indicator As can be seen from the results in the table above, the improvement effect of the traditional Chinese medicine composition of the present invention (Group 1) on various indicators is better than the sum of the improvement effects of the group without Paris polyphylla (Group 2) and the group with Paris polyphylla alone (Group 3). This proves that in the traditional Chinese medicine composition of the present invention, Paris polyphylla produces a synergistic therapeutic effect with other components in the composition.

[0115] As can be seen from the above embodiments and experimental examples, the components in the composition of the present invention have a synergistic effect, resulting in better therapeutic effects in the treatment of seborrheic dermatitis and hair loss.

Claims

1. A traditional Chinese medicine composition, characterized in that, It is made from the following ingredients in parts by weight: 9-11 parts Sophora flavescens, 9-11 parts Phellodendron chinense, 4-6 parts Paris polyphylla, 9-11 parts Nelumbo nucifera, 14-16 parts Kochia scoparia, 14-16 parts Dictamnus dasycarpus, 9-11 parts Mentha haplocalyx, and 19-21 parts Salvia miltiorrhiza.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following ingredients in parts by weight: 10 parts Sophora flavescens, 10 parts Phellodendron chinense, 5 parts Paris polyphylla, 10 parts Nelumbo nucifera, 15 parts Kochia scoparia, 15 parts Dictamnus dasycarpus, 10 parts Mentha haplocalyx, and 20 parts Salvia miltiorrhiza.

3. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that: It is a formulation prepared by adding pharmaceutically acceptable excipients or auxiliary ingredients to the active ingredient, which is the original drug, water or organic solvent extract of the raw material.

4. The traditional Chinese medicine composition according to claim 3, characterized in that: The preparation is for external use.

5. The traditional Chinese medicine composition according to claim 4, characterized in that: The preparations are ointments, creams, gels, liniments, lotions, tinctures, plasters, patches, pastes, powders, coatings, films, aerosols, sprays, or foams.

6. The traditional Chinese medicine composition according to claim 1 or 2, characterized in that: The traditional Chinese medicine composition is used to treat seborrheic dermatitis and / or androgenetic alopecia.

7. Use of the traditional Chinese medicine composition according to any one of claims 1-6 in the preparation of a medicament for treating seborrheic dermatitis.

8. The use according to claim 7, characterized in that: The drug is used to reduce fungal infections on the skin surface and decrease epidermal thickening and inflammatory cell infiltration.

9. Use of the traditional Chinese medicine composition according to any one of claims 1-6 in the preparation of a medicament for treating hair loss.

10. The use according to claim 9, characterized in that: The type of hair loss described is androgenetic alopecia; And / or, the drug is used to increase the number of hair follicles in skin tissue.

Images