Traditional Chinese medicine external washing bag, preparation method and application

Abstract

The invention discloses a traditional Chinese medicine external washing bag, a preparation method and application, and relates to the technical field of traditional Chinese medicine external treatment. Seborrheic dermatitis and scalp psoriasis are two common chronic inflammatory skin diseases, scalp is taken as a main affected part, erythema, scale and pruritus are shown, the illness state is stubborn and easy to relapse, and the life quality of a patient is seriously influenced. In order to solve the problems that in an existing treatment method, external ointment is inconvenient to use, traditional Chinese medicine is time-consuming to decoct and wash, and commercially available lotion is high in cost, the invention provides a traditional Chinese medicine external washing bag which is characterized by being prepared from the following components in parts by mass: 20 parts of radix sophorae flavescentis, 30 parts of cacumen biotae, 15 parts of flos chrysanthemi indici, 10 parts of fructus cnidii, 15 parts of fructus kochiae, 20 parts of herba taraxaci and 30 parts of herba speranskiae tuberculatae. And detoxifying and cooling blood. The traditional Chinese medicine composition is simple to prepare, convenient to use and low in price, can effectively relieve the symptoms of scalp seborrheic dermatitis and scalp psoriasis and improve the skin barrier function, and has a good clinical application prospect.

Description

Technical Field

[0001] The invention relates to the technical field of external treatment with traditional Chinese medicine, and in particular to a traditional Chinese medicine external washing bag, a preparation method and application thereof. Background Art

[0002] Seborrheic dermatitis and scalp psoriasis are two common chronic inflammatory skin diseases, both of which mainly affect the scalp, bringing significant physical and psychological burdens to patients. The incidence of seborrheic dermatitis in the general population is 1% to 3%, while it can be as high as 34% to 83% in patients with low immune function or neurological diseases. The incidence rate in men is higher than that in women. It is more common in young and middle-aged people with vigorous sebaceous gland secretion. The lesions are mostly concentrated in sebum secretion areas such as the head, face, chest and back, of which about 70.3% of cases involve the scalp. As a manifestation of psoriasis, the incidence of scalp psoriasis cannot be ignored. About 45% to 80% of psoriasis patients first show symptoms on the scalp, of which about 25% of patients have lesions limited to this area. It is characterized by erythema with thick scales, itching and even tufts of hair. The condition is recurrent and stubborn, seriously affecting the patient's appearance and self-confidence.

[0003] The occurrence of seborrheic dermatitis involves multiple factors. Studies have shown that hypersecretion of sebaceous glands is an important internal cause. Excessive sebum provides conditions for the overgrowth of Malassezia. The metabolites of Malassezia further trigger immune responses, stimulate keratinocytes to release proinflammatory factors, and lead to inflammation and desquamation. In addition, bacterial proliferation such as Staphylococcus, Streptococcus and Acinetobacter can be seen in the skin of some patients. Repeated inflammation destroys the skin barrier, making it more susceptible to external stimuli, forming a vicious cycle of worsening of the disease. Environmental factors such as high temperature and humidity, greasy diet and alcoholism can also induce or aggravate symptoms. Traditional Chinese medicine attributes it to the combination of wind, dampness and heat, or caused by physical factors such as internal dampness and heat, blood deficiency and wind dryness. Scalp psoriasis is believed to be related to the combined effects of genetics, immune abnormalities and environmental stimuli. Traditional Chinese medicine calls it "white psoriasis" or "pine skin psoriasis". The cause is complex and prone to recurrence.

[0004] Currently, the Western medicine treatment of seborrheic dermatitis mainly focuses on anti-fungal and anti-inflammatory treatments. Topical anti-fungal drugs (such as ketoconazole) and weak corticosteroids are the first choices. For severe cases, drugs such as itraconazole can be taken orally, and keratolytic agents such as salicylic acid lotion are used as adjuvants to relieve scalp symptoms. The treatment of scalp psoriasis mostly relies on topical hormones or calcineurin inhibitors. However, hair obstruction makes it difficult for the ointment to fully contact the lesion, and the drug is sticky and difficult to clean, which affects the curative effect. Traditional Chinese medicine treatment emphasizes syndrome differentiation and treatment. According to syndromes such as blood heat and wind dryness, spleen and stomach damp-heat, or yin deficiency and blood dryness, taking internal medicine prescriptions for clearing heat and cooling blood, strengthening the spleen and removing dampness, or nourishing yin and moistening dryness has significant effects. At the same time, external treatment methods of traditional Chinese medicine such as medicated bath and application have attracted much attention because of their simple operation and direct action. However, the traditional decoction of traditional Chinese medicine for external washing takes a long time and has cumbersome steps, which does not conform to the modern life rhythm and the patient compliance is low; the commercially available proprietary Chinese medicine lotion is relatively expensive, and there is a lack of special products for scalp lesions, so the promotion is limited.

[0005] After retrieval, the Chinese patent with the patent number CN101693088A treats seborrheic dermatitis by taking internal medicine of traditional Chinese medicine. Currently, there is no external washing package of traditional Chinese medicine for treating seborrheic dermatitis by clearing heat and drying dampness, expelling wind and relieving itching, and detoxifying and cooling blood. Summary of the Invention

[0006] In view of the above problems, the present invention aims to provide an external washing package of traditional Chinese medicine, a preparation method and an application thereof, which have multiple effects such as clearing heat and drying dampness, expelling wind and relieving itching, and detoxifying and cooling blood, hitting the pathogenesis of blood dryness, wind preponderance and dampness entrapment, brewing into toxin, so as to treat the symptoms of seborrheic dermatitis (dandruff wind), scalp psoriasis (psoriasis), and scalp folliculitis.

[0007] In order to achieve the above object, the technical solutions adopted by the present invention are as follows:

[0008] An external washing package of traditional Chinese medicine, characterized in that its mass ratio is: 5-15 parts of Xanthium sibiricum, 20-30 parts of Sophora flavescens, 30-40 parts of Platycladus orientalis, 15-20 parts of Chrysanthemum indicum, 10-20 parts of Cnidium monnieri, 15-30 parts of Kochia scoparia, 20-25 parts of Taraxacum mongolicum, 30-40 parts of Speranskia tuberculata.

[0009] Preferably, the mass ratio of the external washing package of traditional Chinese medicine is: 10 parts of Xanthium sibiricum, 30 parts of Sophora flavescens, 40 parts of Platycladus orientalis, 20 parts of Chrysanthemum indicum, 20 parts of Cnidium monnieri, 30 parts of Kochia scoparia, 25 parts of Taraxacum mongolicum, 40 parts of Speranskia tuberculata.

[0010] Preferably, the mass ratio of the external washing package of traditional Chinese medicine is: 10 parts of Xanthium sibiricum, 20 parts of Sophora flavescens, 30 parts of Platycladus orientalis, 15 parts of Chrysanthemum indicum, 10 parts of Cnidium monnieri, 15 parts of Kochia scoparia, 20 parts of Taraxacum mongolicum, 30 parts of Speranskia tuberculata.

[0011] A preparation method of an external washing package of traditional Chinese medicine, comprising the following steps

[0012] Step 1: Take Xanthii Fructus, Sophorae Flavescentis Radix, Platycladi Cacumen, Chrysanthemi Indici Flos, Cnidii Monnieri Fructus, Kochiae Fructus, Taraxaci Herba, and Speranskiae Tuberculatae Herba according to the weight ratio for standby.

[0013] Step 2: Mix Sophorae Flavescentis Radix, Cnidii Monnieri Fructus, Speranskiae Tuberculatae Herba, and Kochiae Fructus, dry them, and perform wall-breaking pulverization (ultrafine pulverization) to obtain Pulverized Product 1 for standby.

[0014] Step 3: Dry and mix Xanthii Fructus, Platycladi Cacumen, Chrysanthemi Indici Flos, and Taraxaci Herba, and pulverize them to 200 meshes to obtain Pulverized Product 2 for standby (because Xanthii Fructus and Platycladi Cacumen contain volatile oils, are prone to volatilization and moisture absorption, and the water extract of Xanthii Fructus is toxic, so wall-breaking pulverization is not used).

[0015] Step 4: Mix Pulverized Product 1 and Pulverized Product 2 evenly according to the volume ratio of 1-2:1-2, and seal them with non-woven fabric according to the required amount to make the finished product.

[0016] Preferably, in Step 4, Pulverized Product 1 and Pulverized Product 2 are mixed evenly according to the volume ratio of 1:2.

[0017] Preferably, in Step 4, Pulverized Product 1 and Pulverized Product 2 are mixed evenly according to the volume ratio of 1:1.

[0018] Preferably, in Step 4, Pulverized Product 1 and Pulverized Product 2 are mixed evenly according to the volume ratio of 2:1.

[0019] Preferably, the application of the traditional Chinese medicine external washing package in the preparation of drugs for treating chronic inflammatory skin diseases.

[0020] Preferably, the chronic inflammatory skin diseases include seborrheic dermatitis and scalp psoriasis.

[0021] The pharmacology of each raw material drug is as follows:

[0022] Xanthii Fructus: Nature and flavor: Warm, pungent, bitter, toxic. Meridian tropism: Lung meridian. Efficacy: Disperse wind-dampness, open nasal orifices, kill insects. Indications: Wind-cold headache, runny nose, rubella itching, damp arthralgia and contracture.

[0023] The 2020 edition of the Chinese Pharmacopoeia stipulates that the oral dosage of Xanthii Fructus is 3-10 g, and the external dosage is not mentioned. Referring to (Liu Guangyun, Bai Li, Miao Mingsan. Toxicity characteristics and external use analysis of slightly toxic traditional Chinese medicines in the 2020 edition of the Pharmacopoeia of the People's Republic of China [J]. Chinese Archives of Traditional Chinese Medicine, 2024, 42(06): 55-59+266.), the general external dosage is 1-3 times the oral dosage, and this external use complies with the regulations.

[0024] Sophorae Flavescentis Radix: Nature and flavor: Bitter, cold. Meridian tropism: Heart meridian, liver meridian, stomach meridian, large intestine meridian, bladder meridian. Efficacy: Clear heat and dry dampness, kill insects, promote diuresis. Indications: Damp heat, jaundice, dysentery, enteritis, skin itching, etc.;

[0025] Platycladus orientalis leaf: Nature and flavor: Bitter, astringent, cold; Meridians entered: lung, liver, spleen meridians; Functions: cooling blood for hemostasis, resolving phlegm for relieving cough, promoting hair growth and blackening hair; Indications: hematemesis, epistaxis, hemoptysis, hematochezia, metrorrhagia and metrostaxis, cough due to lung heat, hair loss due to blood heat, premature graying of hair and beard.

[0026] Wild chrysanthemum: Nature and flavor: Slightly cold, bitter, pungent. Entering the heart meridian and liver meridian. Efficacy: clearing heat and detoxifying, reducing swelling, cooling the liver and improving eyesight. Indications: wind-heat cold, furuncles and carbuncles, sore throat, eczema, etc.

[0027] Cnidium monnieri: Nature and flavor: Pungent, bitter, warm, slightly toxic. Entering the kidney meridian. Functions: killing insects and relieving itching, drying dampness, warming the kidney and strengthening yang. Indications: impotence, cold uterus, leukorrhea with cold-dampness, pain in the lower back due to damp arthralgia; for external use, eczema of vulva, itching of female genitals, trichomonal vaginitis.

[0028] The 2020 edition of the Chinese Pharmacopoeia stipulates that the oral dose of Cnidium monnieri is 3 - 10 g, and the external use is appropriate. Referring to (Liu Guangyun, Bai Li, Miao Mingsan. Toxicity characteristics and external use analysis of slightly toxic traditional Chinese medicines in the 2020 edition of the Pharmacopoeia of the People's Republic of China [J]. Chinese Archives of Traditional Chinese Medicine, 2024, 42(06): 55 - 59 + 266.), generally, the external use amount is 1 - 3 times the oral dose, and this external use complies with the regulations.

[0029] Kochia scoparia fruit: Nature and flavor: Cold, pungent, bitter. Entering the kidney and bladder meridians. Efficacy: clearing heat and promoting diuresis, expelling wind and relieving itching. Used for dysuria, itching of genitals and leukorrhea, rubella, eczema, skin itching.

[0030] Dandelion: Nature and flavor: Bitter, sweet, cold. Entering the liver and stomach meridians. Efficacy: clearing heat and detoxifying, reducing swelling and dissipating nodules, inducing diuresis for treating stranguria, clearing the liver and improving eyesight. Used for treating furuncles and carbuncles, breast abscess, scrofula, red eyes, sore throat, lung abscess, intestinal abscess, jaundice due to damp-heat, stranguria with pain.

[0031] Glandularia conferta: Warm in nature, pungent in flavor. Entering the kidney and liver meridians; Efficacy: expelling wind and removing dampness, relaxing tendons and activating blood circulation, dissipating stasis and reducing swelling, detoxifying and relieving pain. Can be used for treating rheumatic arthralgia, contraction of muscles and bones, cold-damp beriberi, lumbar sprain, paralysis, amenorrhea, eczema of scrotum, sores and carbuncles, etc.

[0032] The beneficial effects of the present invention are:

[0033] The inventor explored the therapeutic experience of traditional Chinese medicine, combined with clinical work practice, and put forward the view of "clearing heat and drying dampness, dispelling wind and relieving itching, detoxifying and cooling blood". According to this treatment principle, a traditional Chinese medicine external washing package prescription for treating this disease was formed. Among them, sophora flavescens and oriental arborvitae leaf are the monarch drugs, which clear heat and dry dampness, and cool blood; supplemented by divaricate saposhnikovia root, fructus cnidii, dandelion, and fructuskochiae as ministerial drugs; dispelling wind, detoxifying and relieving itching, assisted by xanthium sibiricum and wild chrysanthemum to carry the medicine upward, with concentrated medicine power and targeting the pathogenesis of blood dryness, wind preponderance and dampness entrapment, brewing into toxin. Clinical verification shows that this formula can anti-inflammatory, anti-allergic, inhibit fungi and bacteria, reduce sebum secretion, and repair the scalp barrier, and has the efficacy of treating seborrheic dermatitis (dandruff wind), scalp psoriasis (psoriasis), and scalp folliculitis. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required to be used in the embodiments will be briefly introduced below.

[0035] Figure 1 It is a raw material diagram of this traditional Chinese medicine external washing package according to the weight ratio;

[0036] Figure 2 It is a ratio diagram of crushed product 1;

[0037] Figure 3 It is a ratio diagram of crushed product 2;

[0038] Figure 4 It is a product diagram of finished product 1;

[0039] Figure 5 It is a product diagram of finished product 2;

[0040] Figure 6 It is a product diagram of finished product 3;

[0041] Figure 7 It is a comparison diagram before and after the treatment of case 1;

[0042] Figure 8 It is a comparison diagram before and after the treatment of case 2;

[0043] Figure 9 It is a comparison diagram before and after the treatment of case 3;

[0044] Figure 10 It is a comparison diagram before and after the treatment of case 4;

[0045] Figure 11 It is a comparison diagram before and after the treatment of case 5;

[0046] Figure 12 It is a comparison diagram before and after the treatment of case 6;

[0047] Figure 13 It is a comparison diagram before and after the treatment of case 7;

[0048] Figure 14 It is a comparison chart before and after the treatment of Case 8;

[0049] Figure 15 It is a comparison chart before and after the treatment of Case 9;

[0050] Figure 16 It is a comparison of the improvement of clinical symptom scores after the treatment of the two groups Specific implementation manner

[0051] In order to enable ordinary technicians in the field to better understand the technical solution of the present invention, the technical solution of the present invention will be further described below in conjunction with the accompanying drawings and embodiments.

[0052] Example 1

[0053] A traditional Chinese medicine external washing package, the formula is in parts by mass ratio: 10 parts of Xanthium sibiricum, 20 parts of Sophora flavescens, 30 parts of Platycladus orientalis, 15 parts of Chrysanthemum indicum, 10 parts of Cnidium monnieri, 15 parts of Kochia scoparia, 20 parts of Taraxacum mongolicum, 30 parts of Speranskia tuberculata.

[0054] Mix Sophora flavescens, Cnidium monnieri, Speranskia tuberculata, and Kochia scoparia, dry them, and then perform wall-breaking and pulverization (ultrafine pulverization) to make pulverized product 1 for standby;

[0055] Dry and mix Xanthium sibiricum, Platycladus orientalis, Chrysanthemum indicum, and Taraxacum mongolicum and pulverize them to 200 meshes to make pulverized product 2 for standby (because Xanthium sibiricum and Platycladus orientalis contain volatile oils, are easy to volatilize and absorb moisture, and the water extract of Xanthium sibiricum is toxic, so wall-breaking and pulverization are not used);

[0056] Mix (pulverized product 1) and (pulverized product 2) evenly according to the ratio of 1:2 respectively, seal the package with non-woven fabric according to the required amount, and the package weight is 110 ± 5 grams to make finished product 1 (heat-clearing and detoxifying package).

[0057] Mix (pulverized product 1) and (pulverized product 2) evenly according to the ratio of 1:1 respectively, seal the package with non-woven fabric according to the required amount, and the package weight is 110 ± 5 grams to make finished product 2 (moistening dryness and cooling blood package).

[0058] Mix (pulverized product 1) and (pulverized product 2) evenly according to the ratio of 2:1 respectively, seal the package with non-woven fabric according to the required amount, and the package weight is 110 ± 5 grams to make finished product 3 (dandruff-removing, oil-control and itching-relieving package).

[0059] Example 2

[0060] A traditional Chinese medicine external washing package, the formula is in parts by mass ratio: 10 parts of Xanthium sibiricum, 30 parts of Sophora flavescens, 30 parts of Platycladus orientalis, 15 parts of Chrysanthemum indicum, 20 parts of Cnidium monnieri, 30 parts of Kochia scoparia, 20 parts of Taraxacum mongolicum, 40 parts of Speranskia tuberculata.

[0061] Mix Sophora flavescens, Cnidium monnieri, Speranskia tuberculata, and Kochia scoparia, dry them after mixing, then perform wall-breaking and pulverization (ultrafine pulverization), and make the pulverized product 1 for standby;

[0062] Dry and mix Xanthium sibiricum, Platycladus orientalis, Chrysanthemum indicum, and Taraxacum mongolicum, and pulverize them to 200 meshes to make the pulverized product 2 for standby (because Xanthium sibiricum and Platycladus orientalis contain volatile oils, are prone to volatilization and moisture absorption, and the water extract of Xanthium sibiricum is toxic, so wall-breaking pulverization is not adopted);

[0063] Mix (pulverized product 1) and (pulverized product 2) evenly according to the ratio of 1:2 respectively, seal and package them with non-woven fabric according to the required amount, and the package weight is 110 ± 5 grams to make the finished product 1 (heat-clearing and detoxifying package).

[0064] Mix (pulverized product 1) and (pulverized product 2) evenly according to the ratio of 1:1 respectively, seal and package them with non-woven fabric according to the required amount, and the package weight is 110 ± 5 grams to make the finished product 2 (moistening dryness and cooling blood package).

[0065] Mix (pulverized product 1) and (pulverized product 2) evenly according to the ratio of 2:1 respectively, seal and package them with non-woven fabric according to the required amount, and the package weight is 110 ± 5 grams to make the finished product 3 (dandruff-removing, oil-control and itching-relieving package).

[0066] Use the formula of Example 1 as the main treatment formula and conduct the following tests:

[0067] Clinical research report

[0068] 1. Research purpose

[0069] Observe the clinical efficacy of a traditional Chinese medicine external washing package, its preparation method and application in the treatment of seborrheic dermatitis.

[0070] 2. Research subjects

[0071] Use the random table number method to collect 50 patients with seborrheic dermatitis in the dermatology department from June 2024 to December 2024 and divide them into an experimental group and a control group, with 25 cases in each group. Among them, there are 13 males and 12 females in the experimental group, with an age of 30.2 ± 7.81 years and a disease course of 5 (3, 8) months; there are 25 cases in the control group, with 12 males and 13 females, with an age of 32.92 ± 8.63 years and a disease course of 6 (3, 7) months; there are no statistically significant differences in gender, age, disease course, and baseline scores between the two groups of patients (p > 0.05), and they are comparable.

[0072] Inclusion criteria: ① Patients with mild to moderate scalp seborrheic dermatitis aged 18 - 60 years, ② The western medicine diagnosis conforms to the scalp seborrheic dermatitis diagnosis standard in "Chinese Clinical Dermatology"; the main symptoms are erythema, scales, and itching;

[0073] Exclusion criteria: ① Severe seborrheic dermatitis patients with blisters, erosions, exudates, or serous or bloody crusts; ② Patients with other scalp diseases (such as psoriasis, tinea capitis, etc.); ③ Patients who have not used drugs for treating seborrheic dermatitis within 2 weeks before treatment; ④ Pregnant or lactating women who cannot complete the treatment follow-up.

[0074] 3. Treatment methods:

[0075] Control group: Compound glycyrrhizin tablets were taken orally at a dose of 150 mg three times a day, and vitamin B6 tablets were taken orally at a dose of 20 mg three times a day for 4 weeks.

[0076] Treatment group: On the basis of the control group, a traditional Chinese medicine external washing package for treating seborrheic dermatitis containing Chinese herbal medicines was used (prescription composition: 30 g of speranskia tuberculata, 30 g of biota orientalis leaves, 20 g of sophora flavescens, 10 g of cnidium monnieri, 15 g of wild chrysanthemum, 15 g of Kochia scoparia, 10 g of xanthium sibiricum, 20 g of dandelion).

[0077] Specific method: The traditional Chinese medicine external washing package was placed in water at 90°C until it reached room temperature (about 37 - 42°C). Alternatively, the traditional Chinese medicine external washing package could be placed in boiling water for 3 - 5 minutes, then diluted with water for later use. It could be used to wash the hair or apply wet compresses for 5 - 10 minutes, and then rinsed with clean water, once every other day for 4 weeks.

[0078] 4. Efficacy observation:

[0079] 4.1 Dandruff score

[0080] The adherent scalp flaking score (ASFS) of 10 grades was used to evaluate the severity of scalp scales before and after treatment: According to the severity of scalp scales, a score of 0 - 10 was given: Grade 0 indicated no dandruff (none), grades 1 - 2 were small powdery grayish - white rough scales (a small amount), grades 3 - 4 were small to medium - sized scale flakes (mild), grades 5 - 6 were large and thin scale flakes loosely attached to the scalp (moderate), grades 7 - 8 were large adherent scale flakes (obvious), and grades 9 - 10 were thick white - to - yellow scales tightly attached to the scalp (severe).

[0081] 4.2 Lesion score

[0082] The clinical scale for seborrheic dermatitis scalp lesions (4 - grade scoring method) was used to evaluate the improvement of lesion symptoms in patients before and after treatment: 0 points indicated no erythema, 1 point was for mild (a little light red or yellow - red patches, the area of erythema < 20% of the scalp area, and the number of papules ≤ 5), 2 points was for moderate (multiple yellow - red patches with a few isolated papules, the area of erythema accounting for 20% - 40% of the scalp area, and the number of papules 6 - 10), and 3 points was for severe (multiple infiltrated erythemas with a large number of red papules, the area of erythema ≥ 40% of the scalp area, and the number of maculopapules > 10).

[0083] 4.3 Pruritus Score

[0084] The pruritus score scale (4 - level scoring method) was used to evaluate the improvement of pruritus symptoms in subjects before and after treatment: 0 points indicates no pruritus, 1 point indicates mild (barely aware, no need to scratch, easily tolerable), 2 points indicates moderate (obviously aware, sometimes scratch, but can be tolerated, does not affect daily life and sleep), and 3 points indicates severe (often feel itchy, often scratch, difficult to tolerate, affects daily life and sleep).

[0085] 5. Clinical Efficacy Judgment:

[0086] The percentage of efficacy, that is, the total clinical score improvement rate = (sum of clinical symptom scores before treatment - sum of clinical symptom scores after treatment) / sum of clinical symptom scores before treatment × 100%. ① ≥ 90% is considered cured; ② 89% - 50% is considered markedly effective; ③ 49% - 30% is considered improved; ④ < 30% is considered ineffective. The total effective rate of efficacy = (number of cured + number of markedly effective + number of improved) / total number of people × 100%.

[0087] 5.1 Adverse Reactions and Recurrence Rate

[0088] Adverse reactions during medication were recorded, such as skin burning sensation, dry hair, scalp tightness, hair loss, etc. Those with systemic symptoms need further examination. All patients were followed up for 4 weeks after the end of treatment. If new skin lesions or aggravated clinical symptoms reappeared in patients with effective total efficacy evaluation of clinical symptom indicators, it was determined as recurrence. The recurrence rate = (number of recurrence cases / total number of effective cases in the evaluation of clinical symptom indicators) × 100%.

[0089] 5.2 Statistical Analysis:

[0090] SPSS 22 was used for statistical analysis of the data. Measurement data were expressed as , paired - sample t - test or non - parametric Wilcoxon test was used for comparison before and after treatment, and independent - sample t - test or Mann - Whitney U test was used for comparison of efficacy differences between groups; chi - square test was used for count data. A p < 0.05 was considered to indicate a statistically significant difference.

[0091] 5.3 Result Analysis:

[0092] 5.3.1 Comparison of Clinical Symptom Index Improvement

[0093] After 4 - week treatment, the scores of dandruff, skin lesions, pruritus, etc. in both groups were significantly decreased compared with those before treatment, and the differences were clinically significant with p < 0.001 (see Table 1). The total clinical score improvement rate of the experimental group was 63.85 ± 14.09 (%), and that of the control group was 39.06 ± 12.85 (%), with a statistically significant difference (t = 4.95, p < 0.001).

[0094] After 4 weeks of treatment, the total clinical score and dandruff score of the experimental group were 3.08±1.06 points and 1.6±0.75 points respectively, while those of the control group were 5.12±1.32 points and 2.48±0.82 points respectively. There were statistically significant differences between the two groups (t values were -4.71 and -3.24 respectively, and p values were both <0.001); the skin lesion score of the experimental group was 0.76±0.55 points, and that of the control group was 1.48±0.62 points, with a statistically significant difference (Z = 3.31, p <0.001). The itching score of the experimental group was 0.72±0.63 points, which was better than that of the control group (1.16±0.60 points) (Z = 2.03, p = 0.04) (see Table 1, Figure 16 ).

[0095] 5.3.2 Comparison of the total therapeutic effects of the two groups of patients after treatment

[0096] The total effective rate of the experimental group was 96.00%, including 2 cases of cure, 18 cases of marked effect, and 4 cases of effectiveness; the total effective rate of the control group was 72%, including 0 cases of cure, 9 cases of marked effect, and 9 cases of improvement. There were statistically significant differences in the total therapeutic effects of the clinical symptom indicators between the two groups of patients after treatment (χ2 = 5.36, p = 0.04). (see Table 2)

[0097] Table 1 Comparison of the improvement of clinical symptom scores between the two groups before and after treatment

[0098]

[0099]

[0100] Table Note: a: Paired t-test, b: Non-parametric Wilcoxon test

[0101] Table 2 Comparison of the effective rates of the two groups after treatment (%)

[0102]

[0103] 5.3.3 Adverse reactions and recurrence rates

[0104] After treatment, for the incidence of adverse reactions, in the experimental group, 1 case had mild skin irritation and burning during the first external wash, which later subsided on its own; in the control group, 1 case had weight gain, and no obvious abnormalities were found in the rechecked laboratory indicators. Considering it was related to compound glycyrrhizin, no other adverse reactions were observed. One month after the end of the treatment, 2 cases (10.52%) in the experimental group relapsed, and 8 cases (44.44%) in the control group relapsed. There were statistically significant differences in the recurrence rates (χ2 = 5.54, p = 0.02).

[0105] 6. Conclusion

[0106] The combined treatment of traditional Chinese medicine external washing pack and oral medicine for seborrheic dermatitis is superior to simple oral drug treatment in treating mild and moderate seborrheic dermatitis, especially in significantly improving symptoms such as scalp scales, erythema, and itching. The traditional Chinese medicine external washing pack for treating seborrheic dermatitis can reduce the recurrence of the disease.

[0107] For the 14 typical cases in Example 1

[0108] Among them, cases 1 - 10 are seborrheic dermatitis, and cases 11 - 14 are scalp psoriasis.

[0109] Case 1

[0110] Refer to Figure 7 , Liang XX, female, 34 years old, visited on September 17, 2024, outpatient number: 0905019. The main complaint was excessive scalp oil secretion accompanied by recurrent dandruff for 3 years, and the symptoms had worsened in the past 3 months. The patient reported that her scalp had been continuously oily for the past 3 years, especially obvious in summer, and occasionally accompanied by a large amount of dandruff. She had used compound ketoconazole hair lotion by herself, and the symptoms had improved, but the condition relapsed and worsened after discontinuation. In the past 3 months, the symptoms had aggravated without obvious cause, so she came to see a doctor. Physical examination: a large amount of dandruff on the scalp, scalp erythema, mainly on the temporal side of the top of the head, accompanied by itching discomfort. Dermoscopy examination: visible light erythema, irregular blood vessels, considered seborrheic dermatitis. Treatment: Vitamin B6 20mg was taken orally three times a day, Liangxue Xiaofeng San was taken orally with modification, and the external traditional Chinese medicine seborrheic external washing pack 3 was used once a day. After 10 days of follow - up, the scalp erythema subsided, the oil secretion decreased, and the scales significantly reduced. The oral traditional Chinese medicine was discontinued, and the seborrheic shampoo was still used externally once every 2 days. After 2 weeks of follow - up, the scalp erythema completely subsided, and there were occasional bran - like scales. The oil secretion decreased, and the hair could be washed once every 2 days. The patient was instructed to discontinue the oral medicine, and the traditional Chinese medicine external washing pack was used twice a week for consolidation treatment.

[0111] Case 2

[0112] Refer to Figure 8, Liang Moumou, female, 23 years old, outpatient number: 70981207, visited on November 28, 2024. The main complaint was scalp erythema with scales and itching for 2 months. The patient reported that 2 months ago, after changing the shampoo, erythema and scales appeared on the scalp. After stopping using the shampoo, the symptoms did not relieve but gradually worsened. Previously, she had visited the dermatology department of another hospital. Initially, it was considered contact dermatitis or seborrheic dermatitis. Loratadine and compound glycyrrhizin were given orally, and fluocinonide liniment was applied topically. The symptoms improved for a while, but soon recurred after stopping the medication, and the itching was obvious. The patient had a history of atopic dermatitis. Physical examination: The scalp was dry, with a lot of scales, and scratch marks and scabs were visible. Erythema and scales were visible on the eyebrows of the face, and the skin of both lower extremities was dry. Diagnosis: Seborrheic dermatitis (scalp). Mizolastine 10 mg was taken orally once a day, and Runzao Zhiyang Capsules 2 g were taken orally three times a day. The scalp was externally washed with Traditional Chinese Medicine Seborrheic Wash Package 2 once a day. After 2 weeks of follow-up, the scalp desquamation significantly decreased, and the itching relieved. The external wash was changed to once every two days, and the oral medications were stopped, and the treatment was continued for consolidation. After 3 weeks of follow-up, the patient had recovered, the external wash package was stopped, and the patient was advised to pay attention to rest and prevent recurrence.

[0113] Case 3

[0114] Refer to Figure 9 , Zhang Moumou, female, 23 years old, outpatient number: M3736500, visited on January 30, 2024. The patient's main complaint was that there was relatively much oil secretion on the scalp usually, and erythema and scales had appeared in the recent 2 weeks. The patient had obvious oiliness on the scalp and face for a long time and had a history of acne on the face. One year ago, the symptoms improved after taking isotretinoin soft capsules orally. Two weeks ago, due to the great pressure of the exam, erythema, scales, and follicular papules appeared on the scalp, so she came to our department for treatment. Physical examination: There were multiple erythema and scales on the scalp, and some red papules. Dermoscopy was performed: Perifollicular hyperkeratosis, scales, and pustules were visible. Diagnosis: Seborrheic dermatitis. The patient refused oral medication treatment and only externally washed with Seborrheic Wash Package 3 one to two times a day. After 1 week of follow-up, the pustules disappeared, and the scales significantly decreased, but the scalp was still red and occasionally itchy. It was changed to externally apply Seborrheic Wash Package 1 once a day. After 2 weeks of follow-up, the scalp erythema subsided, and the scalp oiliness decreased. Continue to externally apply Seborrheic Wash Package 1 two to three times a week for consolidation treatment.

[0115] Case 4

[0116] Refer to Figure 10, Huang Moumou, male, 62 years old. Since September 3, 2024, the patient has had erythema and scales on the scalp and face for 3 years. He has been to different hospitals for many times and was diagnosed with psoriasis. He was treated with oral topical medications, but the skin lesions did not subside significantly. When he came to our hospital for treatment, he was examined: seborrheic erythema and scales were visible on the face, and erythema on the top of the head, accounting for about 15% of the scalp, with fine scales on it. Vitamin B6, oral compound glycyrrhizic acid glycosides, topical tacrolimus ointment for the face, and topical seborrheic external wash pack 1 for the scalp, washed once a day. After 2 weeks of follow-up, the scalp crust was obviously desquamated, the scalp was dry, and the scales were reduced. It was changed to external wash pack 3 and continued to wash externally. After a follow-up visit one month later, the scalp erythema basically subsided and no scales were seen. It is still undergoing consolidation treatment.

[0117] Case 5

[0118] Reference Figure 11 , Wu Moumou, male, 42 years old, clinic number: 70997507, visited the hospital on August 9, 2023. The patient complained of excessive scalp oil secretion for many years, and erythema, papules and scales appeared in the past three months. The patient has long-term obvious scalp oil, and there is still a lot of oil after washing his hair every day. He has a history of facial acne for many years. Three months ago, due to excessive sweating, erythema, papules and scales appeared on the scalp. The patient used compound ketoconazole lotion for external treatment, but the effect was not good, so he came to our department for treatment. Physical examination: scalp erythema and scales, some of which can be seen with follicular papules. Scalp fungal detection can see yeast, but no hyphae. Diagnosis of seborrheic dermatitis. Oral itraconazole, Chinese medicine dehumidification Wei Ling Tang combined with Lianqiao Baidu Tang plus subtraction. External seborrheic wash 1, once a day. After a follow-up visit 12 days later, the scalp erythema and papules were significantly reduced, and no scales were seen. Fungal test negative. The oral medication was discontinued and replaced with seborrheic wash formula 3, which was continued daily or every other day. After a follow-up visit one month later, the skin lesions had almost disappeared, oil secretion had decreased, and the hair was washed every other day. The patient was advised to continue to apply Chinese medicine twice a week to prevent recurrence.

[0119] Case 6

[0120] Reference Figure 12, Yuan XX, male, 25 years old, outpatient number: M590033, visited on October 6, 2024. The patient complained of scalp erythema, papules accompanied by itching for 3 months. 3 months ago, due to factors such as staying up late and high work pressure, the patient developed scalp erythema, papules and itching. After self-treatment with an anti-dandruff shampoo, the effect was not good, so the patient came to our department for treatment. The patient denied a history of allergies, the scalp sebum secretion was not much, and the hair was washed once every 2-3 days on average. During this visit, the patient clearly requested traditional Chinese medicine treatment. Physical examination: scalp erythema, fine scales, mainly on both temporal sides. The patient complained of fatigue, high pressure, poor sleep at night, listlessness and spontaneous sweating. The tongue was pale with tooth marks and the coating was white, and the pulse was slow. It was considered that spleen deficiency and blood deficiency caused wind. Gui Pi Wan and Wei Ling Tang were used with modifications, and the scalp was treated with Seborrheic Wash Formula 2 externally once every other day. After 2 weeks of follow-up, the patient reported that the spirit had recovered and the sleep at night was okay. Physical examination: The scalp erythema had subsided and the scales had significantly decreased. The patient was relatively satisfied and continued to use the seborrheic lotion once a week for consolidation treatment.

[0121] Case 7

[0122] Huang XX, male, 43 years old, outpatient number: 36487080, visited on November 7, 2024, complaining of scalp erythema, scales accompanied by itching for 3 months. The patient reported that 3 months ago, there were erythema, scales and itching on the scalp without obvious cause. The patient had self-treated with shampoo before, but the effect was not good, and the symptoms had gradually worsened recently. Physical examination showed: multiple scalp erythema, scales, mainly on the top of the head, visible red papules, and some were crusted. It was diagnosed as scalp seborrheic dermatitis. The patient was treated with Traditional Chinese Medicine Seborrheic External Wash Package 1 externally once a day. After 1 week of follow-up, the patient reported that the itching had improved significantly, the scalp erythema had subsided, and the dandruff had decreased. It was changed to Traditional Chinese Medicine External Wash Package 2 for continuous external washing once a day. The patient was advised not to stay up late and eat less greasy and sweet foods. After 1 week of follow-up, the dandruff had significantly decreased and the erythema had completely subsided. The Traditional Chinese Medicine External Wash Package was changed to once every 3 days for consolidation treatment. There was no recurrence during the 1-month follow-up.

[0123] Case 8

[0124] Liu XX, female, 11 years old, outpatient number: M6101568, visited on March 6, 2024. The child complained of scalp erythema accompanied by scales for 1 month. 1 month ago, the child developed scalp erythema and scales, and the itching was not obvious. The child had visited the city skin hospital before, and the fungal examination result was negative. At that time, Shen Bai Lotion and Fluocinonide Liniment were used externally for treatment, but the curative effect was not good, so the child came to our department for treatment. Physical examination: The scalp showed bran-like scales, and some scales adhered to the hair. After peeling, there were no bleeding points or bundled hair. Dermoscopy examination: No blood vessels were seen under the light red background. Diagnosis: Seborrheic dermatitis. The patient was treated with Anti-dandruff and Itch-relieving Package 3 for external washing, and Triamcinolone Acetonide and Econazole Nitrate Cream was applied externally once a day. After 1 week of follow-up, the scales had significantly decreased, and the normal color of the scalp was visible. So the Triamcinolone Acetonide and Econazole Nitrate Cream was stopped, and the Anti-dandruff Package continued to be used for external washing once every 1-2 days. After 2 weeks of follow-up, the scales had almost subsided and there were no other discomforts.

[0125] Case 9

[0126] Ms. Huang, female, 42 years old, outpatient number: M2116710, visited on May 8, 2024. The patient complained of excessive scalp sebum secretion and sparse hair on the top of the head for many years, and the symptoms had worsened in the past two months. The patient had obvious scalp oiliness and sparse hair on the top of the head for a long time, and there was a family history. In the past two months, due to high work pressure and poor sleep at night, the scalp oiliness had increased significantly, accompanied by increased dandruff and itching discomfort, so she came to see a doctor. Physical examination: Excessive scalp oiliness, sparse hair on the top of the head, follicular papules and bran-like desquamation could be seen. Diagnosis: Seborrheic dermatitis, androgenetic alopecia. Vitamin B6 and spironolactone were given orally, and the traditional Chinese medicine Seborrheic Washing Prescription 3 was used for external washing once every other day. After 4 weeks of follow-up, the scalp oiliness decreased and no dandruff was found. The patient was instructed to continue using the traditional Chinese medicine Prescription 2 for external washing twice a week for consolidation treatment.

[0127] Case 10

[0128] Ms. He, female, 33 years old, outpatient number 5516861, visited on August 16, 2024. The patient complained of red patches, scales and itching on the scalp and face, and the course of the disease had reached half a year. Half a year ago, without obvious inducement, the patient began to have red patches, scales and itching symptoms on the head and face, so she went to the local hospital for treatment. After preliminary diagnosis of seborrheic dermatitis, the doctor gave oral medications such as Minone and vitamin B6, and externally used selenium disulfide lotion for treatment, but the curative effect was not good. In the past month, the patient's condition had worsened, and the red patches, scales and itching symptoms had further deteriorated, so she came to our hospital for treatment. Physical examination: Red patches and scales on the scalp, obvious hairline, no obvious bunchy hair was seen. Skin microscopy examination showed uniformly distributed spherical, annular and hairpin-shaped blood vessels. Seborrheic dermatitis was considered. The patient refused oral medication treatment, and tacrolimus cream was used externally on the face, and Seborrheic Washing Package 2 was used for external washing once a day. After 2 weeks of follow-up, the scalp red patches began to subside, the scales decreased, but the itching was still obvious. Then it was changed to Seborrheic Washing Package 3 for external use. After 4 weeks of follow-up, the scalp red patches subsided, the scales decreased, and there was no obvious itching. Continuing consolidation treatment.

[0129] Case 11

[0130] Refer to Figure 13 , Mr. He, male, 51 years old, outpatient number 3977098, visited on August 11, 2024. The patient had suffered from psoriasis for 10 years and was currently receiving treatment with the biological agent secukinumab. The patient reported red patches and scales on the face and scalp, and the symptoms worsened after staying up late or drinking alcohol. Physical examination showed erythema around the mouth and nose, and a small amount of pityriasis scales. There were multiple red patches of different sizes on the scalp, and no obvious scales were seen. The patient refused to use scalp ointment for external treatment, and it was recommended to use Seborrheic Washing Prescription for treatment. After 2 weeks of follow-up, most of the red patches subsided, and a small amount of pityriasis scales appeared. Then it was changed to Washing Package 3 for external use once every other day. After 1 month of follow-up, no skin lesions were seen, and the clinical cure was achieved. The patient was instructed not to stay up late or drink alcohol to prevent recurrence.

[0131] Case 12

[0132] Refer to Figure 14 , Zhou XX, male, 41 years old, outpatient number 2037219, visited on September 2, 2024. The patient reported that he had had erythema and scales all over the body accompanied by itching for 1 year. After routine treatment, the skin lesions on the trunk did not show obvious regression, and there were more skin lesions on the scalp, with tufted hair. Due to a previous history of hepatitis B, the patient refused immunosuppressive agents such as biological agents. Physical examination: Scattered erythema on the trunk, a small amount of scales, and some skin lesions merged into patches; diffuse erythema on the scalp, more scales, and some tufted hair; PASI score was 16 points. The patient was given oral tretinoin tablets 10 mg twice a day, compound glycyrrhizin 150 mg three times a day, and modified traditional Chinese medicine Liangxue Qingying Decoction. For the trunk, halometasone and tacalcitol ointment were used topically, and for the scalp, traditional Chinese medicine external washing package was used externally twice a day. After 2 weeks of follow-up, some skin lesions on the trunk regressed, the scales on the scalp decreased, and the area of erythema shrank. The traditional Chinese medicine external washing package 2 was continued for treatment once a day. After 1 month of follow-up, the erythema on the scalp continued to shrink and no obvious scales were seen. The traditional Chinese medicine was used for external washing once every other day. Continue consolidation treatment.

[0133] Case 13

[0134] Zhou XX, female, 37 years old, outpatient number 50249160, visited on November 6, 2024. The patient has had psoriasis for more than 12 years and has a family history. She has been treated with the biological agent secukinumab for 3 years. Currently, there is a recurrence on the scalp, showing diffuse erythema, which merged into patches, accounting for about 15% of the scalp area, with a small amount of scales and clear boundaries. The curative effect was poor after self-administering calcipotriol betamethasone gel topically. After visiting our department, seborrheic washing package 3 was used externally once a day, and calcipotriol betamethasone gel was continued to be used topically. After 2 weeks of follow-up, the erythema on the scalp regressed and no scales were seen. The patient was instructed to stop using the gel and continue traditional Chinese medicine external washing once every other day for consolidation treatment. After 2 months of follow-up, there was no recurrence. Currently, still in consolidation treatment.

[0135] Case 14

[0136] Refer to Figure 15, Zhao XX, male, 45 years old, outpatient number: M5156945, visited in March 2024. The patient complained of recurrent erythema and scales all over the body for 8 years. The patient has long suffered from psoriasis and is currently receiving biological agent treatment. After treatment, the skin lesions all over the body have been significantly improved and the skin lesions have basically subsided. Nevertheless, erythema and scales still appear on the patient's scalp. After topical treatment with calcipotriol, the symptoms can be relieved, but it is easy to relapse after stopping the drug. At the time of diagnosis, scattered erythema and scales were visible on the patient's scalp, and some areas were fused into patches, mainly concentrated on the top of the head and the frontal hairline, and the scalp area accounted for about 15%. The patient was given continuous maintenance treatment with biological agents, and the scalp was externally applied with seborrheic external washing package 2 once a day. After 2 weeks of follow-up, the color of the scalp erythema area became lighter and the area shrank by 50%. No obvious scales were seen. Then, it was changed to scalp washing package 1 for treatment. After 1 month of follow-up, the skin lesions almost completely subsided, and the treatment was changed to once every 2 days for consolidation treatment.

[0137] Mechanism of action of traditional Chinese medicine external washing package

[0138] This formula is composed of Xanthium sibiricum and Taraxacum officinale on the basis of Kushen Decoction and Tougucao Decoction. The composition and optimization of these 2 formulas will be reviewed below: To further prove the effectiveness of this formula.

[0139] 1. Kushen Decoction

[0140] Recipe: Composed of 8 herbs, including 30g of Sophora flavescens, 30g of Chrysanthemum indicum, 15g of Cnidium monnieri, 10g of Kochia scoparia, 15g of Lonicera japonica, 10g of Angelica dahurica, 10g of Phellodendron amurense, and 10g of Acorus tatarinowii.

[0141] Kushen Decoction comes from "Collection of Experience in Surgical Diseases" written by Gao Bingjun, a surgeon in the Qing Dynasty. In the formula, Sophora flavescens clears heat and dries dampness, and kills insects and relieves itching; Chrysanthemum indicum can disperse wind and clear heat, and dispel wind-heat on the body surface. They are both monarch herbs. Lonicera japonica and Cnidium monnieri are used as minister herbs to clear heat and detoxify, and dry dampness and kill insects. Phellodendron amurense, Kochia scoparia, Acorus tatarinowii, and Angelica dahurica are used as assistants to dispel wind, remove dampness and relieve itching. It is mainly used to treat all kinds of scabies, leprosy and tinea. Modern research has found that it has pharmacological effects such as anti-inflammatory, anti-allergic, antibacterial, inhibiting epidermal proliferation, and promoting ulcer healing. It is mainly used externally to treat skin diseases such as eczema, psoriasis and vulvar pruritus, and all show good curative effects. Among them, there are reports on the external washing of Kushen Decoction for seborrheic dermatitis, and ketoconazole lotion was used as a control and observed for 4 weeks. It was found that 40 patients using Kushen Decoction lotion were superior to ketoconazole lotion in improving itching, scales and sebum overflow. The overall effective rate reached 85.72%, higher than 79.41% of ketoconazole lotion treatment, and the recurrence rate was low.

[0142] 2. Tougucao Decoction

[0143] The Tougucao Formula is a clinical experience formula created by Professor Zhao Bingnan, the "Grandmaster of Dermatology". It consists of 30g of Tougucao, 30g of Cacumen Platycladi, 30g of Gleditsia Sinensis, and 10g of Alum. In the formula, the monarch drug Tougucao is pungent and slightly warm in nature. Pungency can promote dispersion, and warmth can dispel cold-dampness, so it has the effect of expelling wind and removing dampness. The minister drug Cacumen Platycladi is bitter and slightly cold in nature, and can exert the effect of clearing heat and cooling blood. It is an excellent product for treating hair loss due to blood dryness. External use of Gleditsia Sinensis can dispel wind and relieve itching, kill insects and remove dirt. Alum has the effects of relieving heat toxin, stopping itching, drying dampness and expelling insects. This formula is carefully formulated with mild medicinal properties. It can be decocted for external washing or ground into powder for application. It has a significant therapeutic effect on seborrheic alopecia with excessive sebum secretion and scalp itching. It also has significant curative effects on various skin diseases such as psoriasis, folliculitis, and hyperkeratotic tinea pedis. It is also found that soaking with Tougucao can better penetrate the skin, act on the affected area parasitized by fungi, inhibit the growth of fungi, and improve clinical symptoms.

[0144] 3. Characteristics of this formula

[0145] This formula retains the main drugs Kushen, Flos Chrysanthemi Indici, Fructus Cnidii, and Fructus Kochiae in Kushen Decoction on the basis of the ancient formula Kushen Decoction, giving play to their effects of clearing heat and detoxifying, dispelling dampness and relieving itching. It also combines the main drugs Tougucao and Cacumen Platycladi in the Tougucao Formula created by Professor Zhao Bingnan, the "Grandmaster of Dermatology", to give play to the effects of expelling wind and removing dampness, cooling blood, reducing sebum secretion on the skin, removing the Gleditsia Sinensis and Alum in the original formula to prevent excessive dryness, and adding Fructus Xanthii and Herba Taraxaci. Fructus Xanthii has the effects of anti-allergy, anti-inflammation, and relieving itching, and is pungent and dispersing to reach the upper jiao. Adding Herba Taraxaci can enhance the effect of clearing heat and detoxifying, especially better for the syndrome of excessive heat-toxin such as seborrheic dermatitis complicated with pustules and folliculitis.

[0146] This formula uses Kushen, Cacumen Platycladi, and Tougucao as the monarch drugs, mainly for clearing heat and cooling blood, drying dampness. Assisted by Fructus Cnidii, Herba Taraxaci, and Fructus Kochiae to expel wind, relieve itching and detoxify. Adjuvant drugs Fructus Xanthii and Flos Chrysanthemi Indici are used to carry the drugs upward. The medicinal power is concentrated and hits the pathogenesis of damp-heat accumulation and blood dryness generating wind in seborrheic dermatitis. Therefore, it can be used to treat seborrheic dermatitis (White Dandruff Wind) and scalp psoriasis (White Scales).

[0147] 4. Brief introduction to the potential pharmacological effects of the drugs involved in this formula on seborrheic dermatitis:

[0148] Kushen has a variety of pharmacological activities. Matrine can inhibit the expression of IL-17R and prevent the phosphorylation process of p38MAPK, thus inhibiting the release of pro-inflammatory factors and playing an anti-inflammatory role. The total alkaloids of Kushen and the other 4 alkaloids have obvious in vitro antibacterial effects on Staphylococcus aureus and Candida albicans. In the external application experiment model of matrine, it is found that it can inhibit the synthesis of Malassezia and has obvious curative effects in inhibiting fungi.

[0149] Progesterone in Speranskia tuberculata can prevent testosterone from being converted into dihydrotestosterone (DHT) that damages hair follicles, thereby reducing sebum secretion. Many of its components, such as organic acids and volatile oils, have astringent effects on wounds and possess anti-inflammatory and effective anti-allergic reactions. By applying a mouse model, it was demonstrated that Speranskia tuberculata and its extracts can exert their significant antibacterial and anti-inflammatory effects by reducing inflammatory factors in tissues.

[0150] Platycladus orientalis contains components such as flavonoids, volatile oils, tannins, and resins, which have significant inhibitory effects on a variety of microorganisms. Moreover, the flavonoid extract in Platycladus orientalis can supplement the nutritional components of the scalp, thus achieving the effects of hair nourishing and hair growth. And it has a certain repair effect on the scalp barrier, improving the scalp barrier function.

[0151] Kochia scoparia: The main component of Kochia scoparia, saponins, can relieve itching, have anti-inflammatory effects and inhibit allergic reactions. The 70% ethanol extract can inhibit type I and type IV hypersensitivity reactions. The basis for Kochia scoparia to exert its antibacterial effect is the contained volatile oil, which has good inhibitory effects on various dermatophytes such as Trichophyton schoenleinii, and various spore dermatophytes and other skin fungi and bacteria.

[0152] Cnidium monnieri: The extract of osthole in Cnidium monnieri can stabilize mast cells, relieve local swelling, reduce the permeability of capillaries, reduce histamine release, play a role in relieving itching, and can regulate the levels of inflammatory factors to exert anti-inflammatory effects, improving the skin barrier function of patients with seborrheic dermatitis.

[0153] In vitro experiments on the volatile oil of Chrysanthemum indicum found that it can inhibit various bacteria to varying degrees, and the ethanol dilution has an obvious inhibitory effect on Candida albicans. The volatile oil can better improve the local inflammatory reaction in mice, and this effect is concentration-related.

[0154] Xanthium sibiricum: Studies have found that the 70% ethanol extract of Xanthium sibiricum can inhibit compound 48 / 80-induced anaphylactic shock and ovalbumin-induced skin allergy in mice. Its anti-allergic mechanism may be related to stabilizing the mast cell membrane, inhibiting the intake of intracellular calcium ions and increasing the content of cyclic adenosine monophosphate. The fatty oil in Xanthium sibiricum and its processed products has a significant antibacterial effect on Staphylococcus aureus.

[0155] Taraxacum mongolicum: Flavonoids and saponins in Taraxacum mongolicum can inhibit the generation of IL-1β and reduce the expression of pro-inflammatory genes of proteins such as iNOS, COX-2, and NF-kB, showing high anti-inflammatory activity.

[0156] In summary, this traditional Chinese medicine external washing package has effects such as anti-allergic inflammation, inhibiting the inflammatory pathway and the expression of cytokines, inhibiting epidermal proliferation, etc. It can also inhibit the reproduction of fungi such as Malassezia, prevent testosterone from being converted into dihydrotestosterone (DHT) that damages hair follicles, reduce sebum secretion, etc., improve the scalp barrier function, and can be used to treat seborrheic dermatitis and scalp psoriasis.

[0157] The foregoing has shown and described the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited by the above embodiments, and what is described in the above embodiments and the specification is only to illustrate the principle of the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements fall within the scope of the present invention claimed. The scope of the present invention claimed is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine external washing package, characterized in that, The parts by mass ratio are as follows: 5 - 15 parts of Xanthium sibiricum, 20 - 30 parts of Sophora flavescens, 30 - 40 parts of Platycladus orientalis leaf, 15 - 20 parts of Chrysanthemum indicum, 10 - 20 parts of Cnidium monnieri, 15 - 30 parts of Kochia scoparia, 20 - 25 parts of Taraxacum mongolicum, 30 - 40 parts of Speranskia tuberculata.

2. The traditional Chinese medicine external washing packet according to claim 1, characterized in that, 10 parts of Xanthium sibiricum, 30 parts of Sophora flavescens, 40 parts of Platycladus orientalis leaf, 20 parts of Chrysanthemum indicum, 20 parts of Cnidium monnieri, 30 parts of Kochia scoparia, 25 parts of Taraxacum mongolicum, 40 parts of Speranskia tuberculata.

3. The traditional Chinese medicine external washing package according to claim 1, characterized in that, 10 parts of Xanthium sibiricum, 20 parts of Sophora flavescens, 30 parts of Platycladus orientalis leaf, 15 parts of Chrysanthemum indicum, 10 parts of Cnidium monnieri, 15 parts of Kochia scoparia, 20 parts of Taraxacum mongolicum, 30 parts of Speranskia tuberculata.

4. A preparation method of a traditional Chinese medicine external washing package according to any one of claims 1-3, characterized in that: It includes the following steps: Step 1: Weigh Xanthium sibiricum, Sophora flavescens, Platycladus orientalis leaf, Chrysanthemum indicum, Cnidium monnieri, Kochia scoparia, Taraxacum mongolicum, Speranskia tuberculata according to the weight ratio for standby. Step 2: Mix Sophora flavescens, Cnidium monnieri, Speranskia tuberculata, Kochia scoparia, dry them, and perform wall - broken ultrafine grinding to obtain the first pulverized product for standby. Step 3: Dry and mix Xanthium sibiricum, Platycladus orientalis leaf, Chrysanthemum indicum, Taraxacum mongolicum and grind them to 200 meshes to obtain the second pulverized product for standby. Step 4: Mix the first pulverized product and the second pulverized product evenly according to the volume ratio of 1 - 2:1 - 2, and seal - pack them with non - woven fabric according to the required quantity to make the finished product.

5. The preparation method of a traditional Chinese medicine external washing packet according to claim 4, characterized in that: In Step 4, the first pulverized product and the second pulverized product are mixed evenly according to the volume ratio of 1:

2.

6. The preparation method of a traditional Chinese medicine external washing packet according to claim 4, characterized in that: In Step 4, the first pulverized product and the second pulverized product are mixed evenly according to the volume ratio of 1:

1.

7. The preparation method of a traditional Chinese medicine external washing packet according to claim 4, characterized in that: In Step 4, the first pulverized product and the second pulverized product are mixed evenly according to the volume ratio of 2:

1.

8. Use of a traditional Chinese medicine external washing packet according to claims 1 - 3 in the preparation of a drug for treating chronic inflammatory skin diseases.

9. The application according to claim 8, wherein The chronic inflammatory skin diseases include seborrheic dermatitis and scalp psoriasis.

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