Traditional Chinese medicine composition for regulating scalp micro-ecology and external preparation containing traditional Chinese medicine composition and application of external preparation

Abstract

The invention provides a traditional Chinese medicine composition for regulating scalp micro-ecology, an external preparation containing the traditional Chinese medicine composition and application of the external preparation, and relates to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine composition for regulating and controlling scalp micro-ecology is prepared from cacumen biotae, rhizoma cyperi, fructus cnidii, cortex dictamni, radix sanguisorbae, herba ecliptae and herba menthae. Based on the compatibility principle of monarch, minister, assistant and guide, the composition takes fructus cnidii for eliminating dampness and killing parasites as monarch, cortex dictamni and cacumen biotae for removing heat to cool blood as minister, garden burnet, eclipta and rhizoma cyperi for astringing, detoxifying, nourishing yin and regulating qi as assistant, and mint for guiding the medicine to move upwards and transdermal permeation as guide, so that multiple effects of inhibiting bacteria, resisting inflammation, repairing a barrier, regulating sebum secretion and the like are synergistically realized. Modern pharmacological studies show that the active ingredients can inhibit malassezia proliferation, regulate and control inflammatory pathways of NF-kB, TLR4 and the like, reduce expression of proinflammatory factors of IL-6, TNF-alpha and the like, and promote skin barrier repair. Clinical observation shows that the composition can significantly improve the scalp seborrheic dermatitis symptom.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparations, and in particular to a topical preparation containing a traditional Chinese medicine composition for regulating scalp microecology and its application. Background Technology

[0002] Pityriasis alba and seborrheic dermatitis are common chronic inflammatory skin diseases. Their pathogenesis is closely related to the excessive proliferation of Malassezia, abnormal sebum secretion, impaired skin barrier function, and immune inflammatory responses. Studies have shown that Malassezia, as an opportunistic pathogenic fungus, can proliferate in large numbers in the lipid-rich scalp environment, triggering an inflammatory response in the stratum corneum. At the same time, the imbalance of sebum secretion and the destruction of the epidermal barrier further aggravate the dysbiosis, forming a vicious cycle. In addition, molecular-level studies have shown that activation of the Toll-like receptor 4 (TLR4) / nuclear factor-κB (NF-κB) signaling pathway can induce the release of pro-inflammatory factors such as interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and interleukin-1β (IL-1β), leading to symptoms such as erythema, itching, and scaling on the scalp.

[0003] Currently, Western medicine treatments mainly utilize antifungal and anti-inflammatory ingredients such as ketoconazole and selenium sulfide. While these can relieve symptoms in the short term, long-term use can easily lead to drug resistance and often results in adverse reactions such as scalp dryness and irritation. Furthermore, these chemical agents mostly focus on single antibacterial effects and lack the ability to systematically intervene in the regulation of inflammatory pathways, sebum secretion balance, and skin barrier repair, making it difficult to achieve long-term stable regulation of the scalp's microecology.

[0004] In the application of traditional Chinese medicine, existing technologies also have obvious limitations. For example, patent CN107496265A discloses an anti-dandruff and anti-hair loss shampoo powder composed of more than 30 kinds of traditional Chinese medicine. The formula is extensive, focuses on the traditional theory of "dispelling wind and promoting blood circulation," has a low dissolution rate of effective ingredients, poor skin penetration, and unclear modern pharmacological mechanisms. Although patent CN11459531A involves ingredients such as arborvitae leaves, it has not formed a concise formula targeting the multidimensional synergistic regulation of "microbiota-inflammation-barrier," nor has it adopted a formulation technology compatible with modern gentle cleansing systems.

[0005] Therefore, existing technologies still lack a traditional Chinese medicine external preparation that is concise in formulation, has a clear mechanism, possesses multiple functions including antibacterial, anti-inflammatory, sebum-regulating, and barrier-repairing properties, and is well-compatible with mild amino acid surfactants. Researching and developing a safe, mild, long-term usable traditional Chinese medicine composition for regulating scalp microecology and its preparation method has become an urgent technical problem to be solved in this field.

[0006] In view of this, the present invention is hereby proposed. Summary of the Invention

[0007] The primary objective of this invention is to provide a traditional Chinese medicine composition for regulating scalp microecology, wherein the composition can achieve safe and long-term regulation of scalp microecological imbalance.

[0008] A second objective of this invention is to provide a topical preparation.

[0009] A third objective of this invention is to provide an application of the above-mentioned traditional Chinese medicine composition or external preparation.

[0010] In order to achieve the above-mentioned objectives of the present invention, the following technical solution is adopted: This invention provides a traditional Chinese medicine composition for regulating scalp microecology, the composition of which is composed of the following raw materials: Platycladus orientalis leaves, Cyperus rotundus, Cnidium monnieri, Dictamnus dasycarpus root bark, Sanguisorba officinalis root bark, Eclipta prostrata, and Mentha haplocalyx.

[0011] Furthermore, based on parts by weight, the active pharmaceutical ingredients of the traditional Chinese medicine composition include: 25-35 parts of Platycladus orientalis leaves, 15-35 parts of Cyperus rotundus, 8-12 parts of Cnidium monnieri, 12-18 parts of Dictamnus dasycarpus root bark, 10-15 parts of Sanguisorba officinalis, 15-25 parts of Eclipta prostrata, and 6-10 parts of Mentha haplocalyx.

[0012] Furthermore, based on parts by weight, the active pharmaceutical ingredients of the traditional Chinese medicine composition include: 30 parts of arborvitae leaves, 30 parts of cyperus rhizome, 10 parts of cnidium fruit, 15 parts of dictamnus root bark, 15 parts of burnet root, 15 parts of eclipta prostrata, and 10 parts of mint.

[0013] The present invention provides a topical preparation comprising the above-mentioned traditional Chinese medicine composition and a pharmaceutically acceptable carrier or excipient.

[0014] Furthermore, the dosage form of the topical preparation is one of shampoo, spray, conditioning solution, or foam.

[0015] Furthermore, the traditional Chinese medicine composition is added to the external preparation in the form of a traditional Chinese medicine mother liquor, which is obtained by dissolving the formulation particles of each raw material in an aqueous solvent and filtering.

[0016] Furthermore, the pharmaceutically acceptable excipients include at least one of surfactants, humectants, thickeners, preservatives, and pH adjusters.

[0017] Furthermore, the surfactant is an amino acid-based surfactant.

[0018] Furthermore, the amino acid surfactant is one or more of acylglutamate, acylglycine, or acylsarcosine.

[0019] The above-mentioned traditional Chinese medicine composition or external preparation provided by the present invention is used in the preparation of drugs for improving seborrheic dermatitis, scalp eczema, or regulating scalp microecology.

[0020] Compared with the prior art, the beneficial effects of the present invention are as follows: This invention provides a traditional Chinese medicine composition for regulating scalp microecology. The composition comprises Platycladus orientalis leaves, Cyperus rotundus, Cnidium monnieri, Dictamnus dasycarpus root bark, Sanguisorba officinalis, Eclipta prostrata, and Mentha haplocalyx. Based on the traditional Chinese medicine principles of "clearing heat and drying dampness, cooling blood and detoxifying, and strengthening the body's resistance," this composition systematically addresses the core pathogenesis of seborrheic dermatitis and scalp pityriasis versicolor, characterized by "internal damp-heat, blood-heat generating wind, and parasites infesting the skin." Cnidium monnieri is the principal herb, drying dampness and killing parasites, directly targeting the itching and desquamation caused by Malassezia infection. Dictamnus dasycarpus root bark and Platycladus orientalis leaves are the assistant herbs, clearing heat and drying dampness, cooling blood and relieving itching, and enhancing anti-inflammatory and anti-allergic effects. Sanguisorba officinalis, Eclipta prostrata, and Cyperus rotundus are the adjuvant herbs, respectively exerting astringent and detoxifying effects, repairing the skin barrier, nourishing yin and cooling blood, and soothing the liver and regulating qi, as well as regulating sebum, thus simultaneously eliminating pathogens and strengthening the body's resistance. Mentha haplocalyx is the guiding herb, promoting the upward movement of the medicine, dispelling wind and heat, and enhancing drug absorption efficiency through its transdermal absorption-enhancing effect. Meanwhile, modern pharmacological studies have shown that the traditional Chinese medicine composition of this application can inhibit the proliferation of Malassezia through active ingredients such as osthol, and through the synergistic regulation of inflammatory signaling pathways such as NF-κB, Toll-like receptors, and IL-17 by alkaloids and saponins, reduce the expression levels of pro-inflammatory factors such as IL-6 and TNF-α. At the same time, it can promote skin barrier repair by using tannins from Sanguisorba officinalis and flavonoids from Eclipta prostrata, forming a multi-dimensional synergistic network of antibacterial, anti-inflammatory, repair, oil control and penetration promotion, so as to achieve safe and long-term regulation of scalp microecological imbalance.

[0021] This invention provides a topical preparation comprising the aforementioned traditional Chinese medicine composition and a pharmaceutically acceptable carrier or excipient. Due to the effects of the aforementioned traditional Chinese medicine composition, this topical preparation can achieve safe and long-lasting regulation of scalp microecological imbalance.

[0022] The above-mentioned traditional Chinese medicine composition or external preparation provided by the present invention can be widely used in the preparation of drugs for improving seborrheic dermatitis, scalp eczema, or regulating scalp microecology. Detailed Implementation

[0023] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0024] According to one aspect of the present invention, a traditional Chinese medicine composition for regulating scalp microecology, the traditional Chinese medicine composition being composed of the following raw materials: Platycladus orientalis leaves, Cyperus rotundus, Cnidium monnieri, Dictamnus dasycarpus root bark, Sanguisorba officinalis root bark, Eclipta prostrata, and Mentha haplocalyx.

[0025] This invention provides a traditional Chinese medicine composition for regulating scalp microecology. The composition comprises Platycladus orientalis leaves, Cyperus rotundus, Cnidium monnieri, Dictamnus dasycarpus root bark, Sanguisorba officinalis, Eclipta prostrata, and Mentha haplocalyx. Based on the traditional Chinese medicine principles of "clearing heat and drying dampness, cooling blood and detoxifying, and strengthening the body's resistance," this composition systematically addresses the core pathogenesis of seborrheic dermatitis and scalp pityriasis versicolor, characterized by "internal damp-heat, blood-heat generating wind, and parasites infesting the skin." Cnidium monnieri is the principal herb, drying dampness and killing parasites, directly targeting the itching and desquamation caused by Malassezia infection. Dictamnus dasycarpus root bark and Platycladus orientalis leaves are the assistant herbs, clearing heat and drying dampness, cooling blood and relieving itching, and enhancing anti-inflammatory and anti-allergic effects. Sanguisorba officinalis, Eclipta prostrata, and Cyperus rotundus are the adjuvant herbs, respectively exerting astringent and detoxifying effects, repairing the skin barrier, nourishing yin and cooling blood, and soothing the liver and regulating qi, as well as regulating sebum, thus simultaneously eliminating pathogens and strengthening the body's resistance. Mentha haplocalyx is the guiding herb, promoting the upward movement of the medicine, dispelling wind and heat, and enhancing drug absorption efficiency through its transdermal absorption-enhancing effect. Meanwhile, modern pharmacological studies have shown that the traditional Chinese medicine composition of this application can inhibit the proliferation of Malassezia through active ingredients such as osthol, and through the synergistic regulation of inflammatory signaling pathways such as NF-κB, Toll-like receptors, and IL-17 by alkaloids and saponins, reduce the expression levels of pro-inflammatory factors such as IL-6 and TNF-α. At the same time, it can promote skin barrier repair by using tannins from Sanguisorba officinalis and flavonoids from Eclipta prostrata, forming a multi-dimensional synergistic network of antibacterial, anti-inflammatory, repair, oil control and penetration promotion, so as to achieve safe and long-term regulation of scalp microecological imbalance.

[0026] Specifically, the formulation principles of the traditional Chinese medicine composition in this application are as follows: 1. Targeting the root cause, killing parasites and relieving itching: Cnidium monnieri is the principal ingredient. Due to its strong pungent and bitter properties, it can dry dampness and kill parasites. It is mainly used to treat itching and peeling caused by "insects infesting the skin surface" and effectively relieves symptoms related to Malassezia infection.

[0027] 2. Assists in antibacterial and anti-inflammatory effects, clearing heat and drying dampness: Dictamnus dasycarpus root bark and Platycladus orientalis leaf are used as assistant herbs. Dictamnus dasycarpus root bark is bitter and cold, which can clear heat and dry dampness, purge fire and detoxify, and enhance anti-inflammatory and anti-allergic capabilities; Platycladus orientalis leaf is bitter, astringent and slightly cold, which has the effects of cooling blood and relieving itching, astringing and drying dampness, targeting itching caused by "blood heat generating wind", and helping to reduce sebum exudation.

[0028] 3. Synergistic Treatment with Multiple Herbs: Sanguisorba officinalis, Eclipta prostrata, and Cyperus rotundus are used as adjuvant herbs. Sanguisorba officinalis is sour, astringent, and slightly cold, and can astringe and detoxify, promote wound repair, and reduce scaling; Eclipta prostrata is sweet, sour, and cold, and can nourish yin, cool blood, and strengthen hair. Its blood-cooling properties help Platycladus orientalis clear heat toxins from the blood and balance the bitter, cold, and drying properties of the other herbs, reflecting the idea of ​​"strengthening the body's resistance and consolidating its foundation"; Cyperus rotundus is pungent, slightly bitter, and neutral, and can soothe the liver, regulate qi, and harmonize the qi mechanism. "When qi flows, dampness is transformed." Through its qi-regulating effect, it helps to regulate the abnormal sebum metabolism caused by the retention of dampness and turbidity.

[0029] 4. Guiding and harmonizing the effects of other herbs: Peppermint is the guiding herb. It is pungent, cool, and aromatic, and its light and upward-moving properties can guide other herbs to the head, face, and scalp. Its wind-dispelling and heat-clearing properties can penetrate and relieve stagnant heat, quickly relieving itching and discomfort. At the same time, it has a transdermal penetration promoting effect, which enhances the penetration efficiency of all the herbs in the scalp tissue.

[0030] 5. Holistic and synergistic approach, addressing both symptoms and root causes: The traditional Chinese medicine composition for regulating the scalp microecology in this application consists of seven herbs, each with its own function. While eliminating external pathogens, it also addresses internal constitution regulation, achieving fundamental improvement in scalp diseases.

[0031] Furthermore, the traditional Chinese medicine composition of this invention not only has the support of traditional Chinese medicine theory, but also possesses a multi-target synergistic mechanism at the modern pharmacological level. It can achieve comprehensive regulation of the scalp microecology through multiple biological pathways. The specific technical effects are as follows: 1. Directly inhibits the growth of pathogenic microorganisms: Osthol, the main active ingredient in Cnidium monnieri, has a high inhibitory activity against Malassezia, which can directly inhibit the excessive proliferation of this conditionally pathogenic bacterium and control the source of infection.

[0032] 2. Local anti-inflammatory and immune regulation: The alkaloids in Dictamnus dasycarpus root bark and the saponins and tannins in Sanguisorba officinalis root bark can effectively inhibit the activation of inflammatory signaling pathways such as NF-κB in keratinocytes and reduce the expression levels of pro-inflammatory cytokines such as IL-6, TNF-α, and IL-1β, thereby alleviating inflammatory reactions such as scalp erythema and burning.

[0033] 3. Promotes skin barrier repair: The tannins in Sanguisorba officinalis have an astringent effect, which can promote hydration of the stratum corneum and reduce transepidermal water loss; Eclipta prostrata is rich in flavonoids and triterpenoid saponins, which have antioxidant effects and can promote the proliferation and migration of keratinocytes, helping to accelerate the structural repair of damaged scalp barrier.

[0034] 4. Regulate sebum secretion: Cyperene contained in Cyperus rotundus can regulate the lipid metabolism process of sebaceous gland cells; Eclipta prostrata, through its blood-cooling and yin-nourishing effects, regulates the internal factors that lead to excessive sebum secretion from the perspective of "blood heat" and "yin deficiency" in traditional Chinese medicine, and synergistically improves the oily scalp environment and destroys the suitable conditions for the reproduction of Malassezia.

[0035] 5. Construction of a multi-component-multi-target synergistic network: Through network pharmacology analysis, it is predicted that the main active components of the composition of this application (such as osthol, dictamnus tinctoria, sanguisorbin BII, eclipta prostrata flavonoids, menthol, etc.) can work together to target key targets such as PTGS2 (COX-2), TNF, IL6, IL1B, and CASP3. These targets are enriched in the Toll-like receptor signaling pathway, IL-17 signaling pathway, NF-κB signaling pathway, and apoptosis pathway, revealing the modern scientific basis for their multi-pathway synergistic regulation of scalp immune status and microecological environment.

[0036] 6. Enhances drug penetration and provides immediate relief: Menthol contained in peppermint can stimulate the skin's cold receptors, producing a cooling sensation and quickly relieving itching; at the same time, as a natural transdermal penetration enhancer, it can improve the distribution and absorption efficiency of other active ingredients in the scalp tissue, thereby increasing the overall speed of drug efficacy.

[0037] As an optional embodiment, the raw materials of the traditional Chinese medicine composition include, by mass parts: 25-35 parts of Platycladus orientalis leaves, 15-35 parts of Cyperus rotundus, 8-12 parts of Cnidium monnieri, 12-18 parts of Dictamnus dasycarpus root bark, 10-15 parts of Sanguisorba officinalis, 15-25 parts of Eclipta prostrata, and 6-10 parts of Mentha haplocalyx.

[0038] The dosage of Platycladus orientalis leaves can be, for example, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, or 35 parts, or any integer value between 25 and 35 parts; the dosage of Cyperus rotundus can be, for example, 15, 20, 25, 30, or 35 parts, or any integer value between 15 and 35 parts; the dosage of Cnidium monnieri can be, for example, 8, 9, 10, 11, or 12 parts, or any integer value between 8 and 12 parts; the dosage of Dictamnus dasycarpus bark can be, for example, 12, 13, 14, 15, or 1... The dosage of Sanguisorba officinalis can be 6, 17, or 18 parts, or any integer value between 12 and 18 parts; the dosage of Sanguisorba officinalis can be 10, 11, 12, 13, 14, or 15 parts, or any integer value between 10 and 15 parts; the dosage of Eclipta prostrata can be 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, or 25 parts, or any integer value between 15 and 25 parts; the dosage of Mentha haplocalyx can be 6, 7, 8, 9, or 10 parts, or any integer value between 6 and 10 parts.

[0039] In a preferred embodiment of the present invention, the raw materials of the traditional Chinese medicine composition, by weight, include: 30 parts of Platycladus orientalis leaves, 30 parts of Cyperus rotundus, 10 parts of Cnidium monnieri, 15 parts of Dictamnus dasycarpus root bark, 15 parts of Sanguisorba officinalis root bark, 15 parts of Eclipta prostrata, and 10 parts of Mentha haplocalyx.

[0040] According to one aspect of the present invention, a topical preparation comprising the above-mentioned traditional Chinese medicine composition and a pharmaceutically acceptable carrier or excipient.

[0041] This invention provides a topical preparation comprising the aforementioned traditional Chinese medicine composition and a pharmaceutically acceptable carrier or excipient. Due to the effects of the aforementioned traditional Chinese medicine composition, this topical preparation can achieve safe and long-lasting regulation of scalp microecological imbalance.

[0042] In a preferred embodiment of the present invention, the dosage form of the topical preparation is one of shampoo, spray, conditioning solution or foam.

[0043] In a preferred embodiment of the present invention, the traditional Chinese medicine composition is added to the external preparation in the form of a traditional Chinese medicine mother liquor, which is obtained by dissolving the formulation particles of each raw material in an aqueous solvent and filtering.

[0044] In a preferred embodiment, the traditional Chinese medicine composition in the topical formulation of this application is added in the form of a traditional Chinese medicine mother liquor, which is obtained by dissolving the formulation particles of each active pharmaceutical ingredient in an aqueous solvent and then filtering. This preparation method is simple to operate, eliminates the need for traditional decoction, and effectively avoids the destruction of heat-sensitive active ingredients by high temperatures. At the same time, the dissolution and filtration steps yield a clear and stable extract, which is beneficial for subsequent uniform mixing with the surfactant system and improves the physical stability of the formulation.

[0045] In a preferred embodiment of the present invention, the pharmaceutically acceptable excipients include at least one of surfactants, humectants, thickeners, preservatives, and pH adjusters.

[0046] In a preferred embodiment of the present invention, the surfactant is an amino acid surfactant.

[0047] As a preferred embodiment, this application uses amino acid surfactants as the cleaning ingredient, which are gentle on the skin, low in irritation, and can effectively reduce damage to the scalp barrier. They are chemically stable and have good compatibility with the mother liquor of traditional Chinese medicine, which helps maintain the uniformity and stability of the preparation system. At the same time, the pH range of amino acid surfactants is similar to the physiological environment of the scalp, making it easy to adjust to a weakly acidic condition of 5.5~6.0, enhancing the comfort during use, and making them suitable for long-term daily care, especially for people with sensitive scalps and those who need frequent washing and conditioning.

[0048] In the preferred embodiments described above, the amino acid surfactant is one or more of acylglutamate, acylglycine, or acylsarcosine.

[0049] According to one aspect of the present invention, the above-mentioned traditional Chinese medicine composition or topical preparation is used in the preparation of a medicine for improving seborrheic dermatitis or regulating the scalp microecology.

[0050] The above-mentioned traditional Chinese medicine composition or external preparation provided by the present invention can be widely used in the preparation of drugs for improving seborrheic dermatitis, scalp eczema, or regulating scalp microecology.

[0051] The technical solution of the present invention will be further described below with reference to the embodiments.

[0052] Examples 1-3 A functional shampoo for regulating scalp microecology, the preparation method of the shampoo comprising: (1) Raw material weighing: Weigh each Chinese herbal medicine formula granules according to the following weight parts: 30 parts of arborvitae leaf, 30 parts of cyperus rhizome, 10 parts of cnidium fruit, 15 parts of dictamnus root bark, 15 parts of burnet root, 15 parts of eclipta prostrata, and 10 parts of mint.

[0053] (2) Preparation of Chinese medicine mother liquor: After mixing the above Chinese medicine formula granules evenly, add purified water to dissolve them. Add 10 mL of purified water to every 1 g of Chinese medicine formula granules, and stir at 300 rpm for 30 minutes under 50℃ water bath conditions to fully dissolve the active ingredients and obtain a clear or slightly turbid Chinese medicine solution.

[0054] The obtained Chinese herbal solution was filtered under reduced pressure through a 0.45 μm microporous membrane to remove insoluble impurities. The filtrate was collected to obtain the Chinese herbal mother liquor.

[0055] (3) Formulation: Take 10 parts by weight of the above-mentioned Chinese medicine mother liquor and slowly add it to 84.3 parts by weight of sodium lauroyl glutamate (concentration of 30% w / v) and mix well. Then add 5 parts of humectant (glycerin), 0.5 parts of thickener (xanthan gum) and 0.2 parts of preservative (ethylparaben). Stir while adding, keep the stirring speed at 100 rpm and continue mixing for 20 minutes until the system is uniform.

[0056] Adjust the pH of the mixture to 5.8 with lactic acid, and continue stirring for 10 minutes to stabilize the system, thus obtaining the functional shampoo.

[0057] Examples 2 and 3 A functional shampoo for regulating scalp microecology, the preparation method of the shampoo comprising: (1) Raw material weighing: Weigh each Chinese medicine formula granule according to the following weight parts, see Table 1 for details.

[0058] Table 1:

[0059] (2) Preparation of mother liquor of traditional Chinese medicine: Same as in Example 1; (3) Formulation: Same as in Example 1.

[0060] Comparative Examples 1-4 A functional shampoo for regulating scalp microecology, the preparation method of the shampoo comprising: (1) Raw material weighing: Weigh each Chinese medicine formula granule according to the following weight parts, see Table 2 for details.

[0061] Table 2:

[0062] (2) Preparation of mother liquor of traditional Chinese medicine: Same as in Example 1; (3) Formulation: Same as in Example 1.

[0063] Comparative Example 5 This comparative example is the same as Example 1, except that Cyperus rotundus in the raw materials is replaced with an equal amount of Scutellaria baicalensis.

[0064] Experimental Example 1 To evaluate the clinical efficacy of the traditional Chinese medicine composition described in this invention in improving the symptoms of seborrheic dermatitis of the scalp, the following clinical observation study was conducted using the functional shampoo prepared in Example 1 as an example.

[0065] I. Research Subjects and Methods: 1. Case selection criteria: Patients diagnosed with mild to moderate seborrheic dermatitis of the scalp at the Dermatology Clinic of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine between June 2024 and March 2025 were selected. The diagnosis was based on the Williams International Diagnostic Criteria. There were 16 males and 14 females, aged 18 to 52 years, with a mean age of (34.5±9.1) years. Patients who were using other medications for scalp diseases (such as topical hormones, antifungals, etc.) or had recently received systemic treatment were excluded.

[0066] 2. Treatment plan: After all patients discontinued other related medications and shampoos (with a 1-week shampooing period), they began using the functional shampoo prepared in Example 1 of this invention. Patients were instructed to wash their hair 3 times a week, applying an appropriate amount of product to the scalp for 5 minutes each time, followed by rinsing thoroughly with water, for a continuous period of 4 weeks.

[0067] 3. Efficacy evaluation indicators: The total severity scoring method was used for evaluation. The same physician scored the patients in a blinded manner before treatment, at the end of the second week of treatment, and at the end of the fourth week of treatment. The scoring items included three symptoms: itching, erythema, and scaling. Each symptom was scored on a four-level scale of 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The total score was the sum of the scores of the three symptoms (maximum score of 9 points).

[0068] Calculate the efficacy index: Therapeutic effect index = (Total score before treatment - Total score after treatment) / Total score before treatment × 100%; The criteria for judging the efficacy are as follows: Cured: Efficacy index ≥ 90%; Significantly effective: 60% ≤ Efficacy index < 90%; Effective: 20% ≤ Efficacy index < 60%; Ineffective: Efficacy index < 20%.

[0069] Overall effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases × 100%.

[0070] 4. Safety evaluation: Record any local irritation, allergic reactions or other adverse events that occur during treatment.

[0071] II. Results: 1. Clinical efficacy: After 4 weeks of treatment, the overall effective rate of the 30 patients was 93.33%. Specific results are shown in Table 1.

[0072] Table 1. Statistical results of clinical efficacy (n=30):

[0073] 2. Changes in symptom scores: After treatment, the scores of each symptom and the total score of the patients decreased significantly compared with those before treatment (P<0.01).

[0074] After 4 weeks of treatment, the pruritus score decreased by approximately 73.1% (from 2.23±0.68 to 0.60±0.56), the erythema score decreased by approximately 65.2% (from 2.10±0.66 to 0.73±0.58), the scaling score decreased by approximately 64.5% (from 2.17±0.65 to 0.77±0.57), and the total severity score decreased by approximately 67.7% (from 6.50±1.72 to 2.1±1.51). Specific data are shown in Table 2.

[0075] Table 2. Comparison of symptom scores before and after treatment (x±s, n=30):

[0076] Note: Compared with before treatment, P<0.05, * P<0.01.

[0077] 3. Safety: All patients completed the study, and no adverse events such as local irritation or allergies related to the investigational product were observed.

[0078] III. Typical Cases: Case 3: Patient Li, male, 35 years old. Before treatment, he had significant scalp itching, erythema, and scaling, with a total score of 7. After using the shampoo of this invention for 2 weeks, the itching was significantly reduced and the scaling decreased; after 4 weeks, the symptoms basically disappeared, the total score dropped to 1, the efficacy index was 85.7%, and it was judged to be significantly effective.

[0079] Clinical observations in this trial demonstrate that the herbal composition of this invention can significantly improve the clinical symptoms of patients with seborrheic dermatitis of the scalp, with a high overall effective rate and rapid onset of action (significant improvement within 2 weeks), and good safety, fully verifying its clinical application value.

[0080] Experimental Example 2: In vitro antibacterial experiment The minimum inhibitory concentration (MIC) of the traditional Chinese medicine mother liquor in Examples 1-3 and Comparative Examples 1-5 of this invention against Malassezia was determined by microdilution method. At the same time, commercially available 2% ketoconazole lotion (Kangwang) was used as a positive control, and traditional decoctions obtained from the raw materials in Example 1 of this application were used as decoction controls. The results are shown in Table 3.

[0081] Table 3. Results of in vitro antibacterial experiment:

[0082] As shown in the above in vitro antibacterial experiments, the mother liquor of the traditional Chinese medicine compositions obtained in Examples 1-3 of this invention exhibits significantly better antibacterial activity than the traditional decoction (MIC value is 4 times lower), indicating that modern preparation processes can better preserve and extract the effective components. Although the direct MIC value of the traditional Chinese medicine compositions in Examples 1-3 of this invention is higher than that of ketoconazole, considering their multi-target, anti-inflammatory, and sebum-regulating effects, the traditional Chinese medicine compositions of this invention have greater potential in maintaining long-term microecological balance.

[0083] In contrast, the implementation method in Comparative Example 1, which did not contain Cnidium monnieri, showed a significant increase in MIC value, indicating that the absence of the principal drug Cnidium monnieri directly led to a substantial decrease in the core antibacterial ability. In contrast, the implementation method that did not include Dictamnus dasycarpus root bark in Comparative Example 2 showed an increase in MIC value to that of traditional decoction, indicating that the absence of the herb Dictamnus dasycarpus root bark weakened the synergistic effect of anti-inflammatory and antibacterial activity. In contrast, the implementation method without Sanguisorba officinalis in Comparative Example 3 showed an increased MIC value, indicating that the astringent and detoxifying effects of the adjuvant Sanguisorba officinalis contributed to both antibacterial and barrier repair. In contrast, the MIC value of the implementation method that did not include Eclipta prostrata in Comparative Example 4 was higher, suggesting that the yin-nourishing and blood-cooling components of Eclipta prostrata have an auxiliary effect in maintaining the overall efficacy environment. In contrast, in Comparative Example 5, where Cyperus rotundus was replaced with Scutellaria baicalensis, the MIC value increased significantly, and the effects of regulating qi and lipids were lost, proving that Cyperus rotundus is irreplaceable in regulating the sebaceous microenvironment.

[0084] Experimental Example 3: In vitro anti-inflammatory experiment An in vitro inflammation model was constructed using lipopolysaccharide (LPS)-induced immortalized human keratinocytes (HaCaT). A blank control group, an LPS model group, and a group treated with the traditional Chinese medicine mother liquor from Example 1 of this invention (with high, medium, and low concentrations) were set up. The concentrations of IL-6 and TNF-α in the cell supernatant were detected by ELISA.

[0085] Specific testing methods: 1. Cell Culture and Grouping: HaCaT cells were cultured in DMEM complete medium. The experiment was divided into three groups: a blank control group, an LPS model group (1 μg / mL LPS stimulation), and the traditional Chinese medicine mother liquor treatment group from Example 1 of this invention (with three concentrations: high concentration 200 μg / mL, medium concentration 100 μg / mL, and low concentration 50 μg / mL). The traditional Chinese medicine mother liquor was added to the culture system 2 hours before LPS stimulation.

[0086] 2. Stimulation and collection: After adding LPS and continuing to culture for 24 hours, collect the cell supernatant.

[0087] 3. Factor detection: The concentrations of IL-6 and TNF-α in the cell supernatant were detected by strictly following the instructions using an ELISA kit.

[0088] Table 4. Results of in vitro anti-inflammatory experiments (x±s, n=3):

[0089] Note: Compared with the blank control group, ## P<0.01; compared with the LPS model group, * P<0.05, ** P<0.01.

[0090] Conclusion: The composition of the present invention can significantly inhibit the release of LPS-induced inflammatory factors IL-6 and TNF-α from HaCaT cells in a concentration-dependent manner, confirming its good anti-inflammatory activity.

[0091] In conclusion, the antibacterial activity of the herbal composition of this invention is significantly superior to that of the traditional decoction (MIC value is 4 times lower), indicating that modern preparation processes can better preserve and extract the active ingredients. Although its direct MIC value is higher than that of ketoconazole, its combined effects of multi-target action, anti-inflammatory (such as significantly reducing IL-6 and TNF-α), sebum regulation, and barrier repair make it more promising in maintaining long-term microecological balance.

[0092] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for regulating scalp microecology, characterized in that, The traditional Chinese medicine composition consists of the following raw materials: Platycladus orientalis leaves, Cyperus rotundus, Cnidium monnieri, Dictamnus dasycarpus root bark, Sanguisorba officinalis root bark, Eclipta prostrata, and Mentha haplocalyx.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The active pharmaceutical ingredients of the traditional Chinese medicine composition, by weight, include: 25-35 parts of Platycladus orientalis leaves, 15-35 parts of Cyperus rotundus, 8-12 parts of Cnidium monnieri, 12-18 parts of Dictamnus dasycarpus root bark, 10-15 parts of Sanguisorba officinalis, 15-25 parts of Eclipta prostrata, and 6-10 parts of Mentha haplocalyx.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The active pharmaceutical ingredients of the traditional Chinese medicine composition, by weight, include: 30 parts of arborvitae leaves, 30 parts of cyperus rhizome, 10 parts of cnidium fruit, 15 parts of dictamnus root bark, 15 parts of burnet root, 15 parts of eclipta prostrata, and 10 parts of mint.

4. A topical preparation, characterized in that, The topical preparation comprises the traditional Chinese medicine composition according to any one of claims 1 to 3 and a pharmaceutically acceptable carrier or excipient.

5. The topical preparation according to claim 4, characterized in that, The dosage form of the topical preparation is one of shampoo, spray, conditioning solution or foam.

6. The topical preparation according to claim 4, characterized in that, The traditional Chinese medicine composition is added to the external preparation in the form of a traditional Chinese medicine mother liquor, which is obtained by dissolving the formulation particles of each raw material in an aqueous solvent and filtering.

7. The topical preparation according to claim 4, characterized in that, The pharmaceutically acceptable excipients include at least one of surfactants, humectants, thickeners, preservatives, and pH adjusters.

8. The topical preparation according to claim 7, characterized in that, The surfactant is an amino acid-based surfactant.

9. The topical preparation according to claim 8, characterized in that, The amino acid surfactant is one or more of acylglutamate, acylglycine, or acylsarcosine.

10. The use of the traditional Chinese medicine composition of any one of claims 1 to 3 or the topical preparation of any one of claims 4 to 9 in the preparation of a drug for improving seborrheic dermatitis or regulating the scalp microecology.

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