A traditional Chinese medicine composition for the prevention or treatment of hair loss

Abstract

This invention relates to a traditional Chinese medicine composition for the prevention or treatment of hair loss, made from ginseng, astragalus, arborvitae, ginger, soapberry, artemisia annua, rehmannia glutinosa, and notoginseng, which promotes hair follicle formation and growth, increases the number of hair follicles, and has low skin irritation.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition for the prevention or treatment of hair loss. Background Technology

[0002] With increasing life and work pressures in modern society, hair loss is becoming increasingly prevalent among younger people. Common causes include: In some individuals, hair follicles on the top of the scalp tend to accumulate androgens. Excessive androgens are easily oxidized by enzymes into dihydrotestosterone (DHT), which induces the production of reactive oxygen species and inflammation, damaging hair follicles and severely impacting the microcirculation system. Androgens can also induce excessive sebum secretion from the sebaceous glands. Excessive sebum can cause inflammation and blockage, leading to follicle atrophy, shortened hair growth cycle, and thinning and eventual hair loss. Furthermore, endocrine and hormonal imbalances can increase oxidative stress, damaging hair follicles and disrupting the hair growth cycle, resulting in hair loss. Additionally, external stimuli can damage the scalp environment, weakening its ability to anchor hair follicles and causing hair loss.

[0003] Wang Lifei reported in "A Correlation Study of Etiological Factors and Traditional Chinese Medicine Syndrome Differentiation in 214 Patients with Seborrheic Alopecia" that the patients' TCM syndrome differentiation was, in descending order, damp-heat accumulation syndrome, blood deficiency and wind-dryness syndrome, and liver and kidney deficiency syndrome. The age of onset and TCM syndrome differentiation showed significant differences; the course of the disease also showed significant differences. Wang Yijun reported in "A Study on the Medication Patterns of Contemporary Physicians in Treating Seborrheic Alopecia Based on Data Mining" that contemporary physicians often use the following TCM prescriptions to treat blood-heat and wind-dryness type seborrheic alopecia: Astragalus membranaceus, Rehmannia glutinosa, and Polygonum multiflorum; for spleen and stomach damp-heat type, Poria cocos, Coix lacryma-jobi, and Atractylodes macrocephala; and for liver and kidney deficiency type, Ligustrum lucidum, Polygonum multiflorum, and Eclipta prostrata. The medicinal properties of the herbs used to treat blood-heat and wind-dryness type, spleen and stomach damp-heat type, and liver and kidney deficiency type seborrheic alopecia were all cold and sweet; the most common herbs entered the liver meridian, and the herbs were mainly those that nourish yin and blood, strengthen the spleen and remove dampness, and nourish the liver and kidneys. In her clinical research on the risk factors of seborrheic alopecia and its relationship with TCM constitution, Zhang Yueyue found that a family history of seborrheic alopecia, phlegm-dampness constitution, and yin deficiency constitution may be risk factors for the onset of seborrheic alopecia.

[0004] CN116270855B discloses a traditional Chinese medicine composition for treating hair loss, prepared from the following herbs: raw arborvitae, mulberry leaves, eclipta prostrata, vitex trifolia, cuscuta chinensis, astragalus membranaceus, peppermint, cockscomb flower, and salvia miltiorrhiza, which can increase the number of hair follicles. CN115869352B discloses a traditional Chinese medicine compound preparation for treating androgenetic alopecia, made from arborvitae leaves, prepared he shou wu, dandelion, kudzu root, clematis chinensis, and peppermint, which can relieve dampness and turbidity on the scalp of patients with androgenetic alopecia, promote qi and blood circulation, and thus prevent hair loss; it also has antibacterial and anti-inflammatory properties, and nourishes the internal organs, allowing the hair to receive continuous nourishment from the internal organs. CN107551021B

[0005] A topical medication for preventing and treating hair loss caused by damp-heat is disclosed. The principal ingredient is *Gynostemma pentaphyllum*, which is slightly cold in nature and has a slightly bitter and astringent taste, with the effects of clearing heat and detoxifying, cooling blood and promoting diuresis. The assistant ingredients are *Plantago asiatica*, *Euphorbia hirta*, *Hedyotis diffusa*, and *Hibiscus mutabilis* leaves, which assist *Gynostemma pentaphyllum* in clearing heat and detoxifying, cooling blood and promoting diuresis. Citron oil and patchouli oil are adjuvant ingredients, which inhibit the growth of pathogenic bacteria caused by increased scalp secretions due to damp-heat, and simultaneously promote microcirculation in the skin. Camphor oil is the guiding ingredient, which has a mild stimulating effect on the skin, guiding the drug to transdermal absorption. It has the effects of clearing heat and detoxifying, strengthening the spleen and promoting diuresis, cooling blood and reducing swelling, and mildly stimulating the skin and hair follicles, and is used for hair loss caused by damp-heat. US20220354915A1 discloses a composition for preventing hair loss or promoting hair growth, which contains ginsenoside Rg4 or a mixture of ginsenosides Rg2, Rg4, Rg6, and Rh1 as active ingredients. Treatment of human hair follicle dermal papilla cells with ginsenoside Rg4 or a mixture of ginsenosides Rg2, Rg4, Rg6 and Rh1 showed the desired effect of forming three-dimensional spheres that could induce hair follicle formation and growth and increase their size.

[0006] Currently, traditional Chinese medicine (TCM) treatments for hair loss typically employ follicle-stimulating drugs, such as those that clear heat and promote diuresis. However, excessive use of these bitter and cold herbs can easily damage Yin, and some of these herbs also have skin irritation properties, making safe use difficult to guarantee. Therefore, there is still a need to develop a TCM composition that can effectively improve hair loss while also having less or acceptable skin irritation or higher safety. Summary of the Invention

[0007] The purpose of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition for the prevention or treatment of hair loss, which can effectively prevent or treat hair loss, especially seborrheic alopecia, while reducing skin irritation and improving safety of use.

[0008] The technical solution of this invention is summarized as follows:

[0009] A traditional Chinese medicine composition for the prevention or treatment of hair loss, wherein the traditional Chinese medicine composition is made from the following raw materials in parts by weight: ginseng 1-15 parts, astragalus 1-20 parts, arborvitae 5-80 parts, ginger 5-80 parts, soapberry 1-10 parts, artemisia annua 1-30 parts, rehmannia glutinosa 5-50 parts, and notoginseng 1-30 parts.

[0010] Ginseng is the dried root of *Panax ginseng* CA Mey., a plant belonging to the Araliaceae family. It enters the spleen, lung, and heart meridians, and is sweet, slightly bitter, and neutral in nature. It contains ginsenosides A, B, C, D, E, and F. Ginsenoside A (C42H72O14) is ginsenoside Rg1. Hydrolysis of ginsenosides B and C yields panaxatriol sapogenin, while hydrolysis of ginsenosides D, E, and F yields 20-epiprotopanaxo-diol sapogenin. Ginseng has an excitatory effect on the central nervous system, enhancing the excitation and inhibition processes of higher nervous activity in animals, increasing the body's adaptability to all non-specific stimuli, and reducing fatigue. It has a certain therapeutic effect on cardiovascular diseases such as hypertension, myocardial malnutrition, coronary artery sclerosis, and angina pectoris.

[0011] Astragalus is the dried root of *Astragalus membranaceus* or *Astragalus mongholicus*, both belonging to the legume family. It tonifies qi and strengthens the exterior, promotes diuresis and eliminates toxins, drains pus, and promotes tissue regeneration. It is used for qi deficiency and fatigue, poor appetite and loose stools, qi sinking, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, carbuncles that are difficult to heal, chronic ulcers that do not heal, anemia and chlorosis, internal heat and thirst; proteinuria in chronic nephritis, and diabetes. Astragalus contains flavonoids such as calycosin and 3-hydroxy-9,10-dimethoxysphranane, as well as astragalosides I, V, and III.

[0012] Chinese arborvitae (Platycladus orientalis) (L.) Franco, a plant in the Cupressaceae family, is known for its dried branches and leaves. It enters the lung, liver, and spleen meridians and has the functions of cooling the blood and stopping bleeding, promoting hair growth and darkening hair. It is used for hematemesis, epistaxis, hemoptysis, hematochezia, metrorrhagia, hair loss due to blood heat, and premature graying of hair.

[0013] Ginger is the fresh rhizome of Zingiber officinale Rosc., a plant in the ginger family. It is pungent and slightly warm in nature. It mainly contains volatile oils, such as gingerol, phellandrene, gingerene, citral, and gingerol. These volatile oil components can cause skin hyperemia, improve local blood circulation, and alleviate hair loss symptoms. However, these volatile oils also have a certain degree of skin irritation.

[0014] Sapindus mukorossi Gaertn., a plant belonging to the Sapindaceae family and the Sapindaceae genus, is used medicinally for its roots and fruits. The fruit is bitter, slightly pungent, and cold in nature, and slightly toxic. The roots are bitter and cool in nature. Studies have shown that the pericarp of Sapindus mukorossi contains a large amount of saponins. The main surfactants in Sapindus mukorossi saponin extract are triterpenoid saponins (I), sesquiterpenoid glycosides (II), fatty oils, and proteins. It is a natural nonionic surfactant that can be used as a natural surfactant in natural shampoos and various cleansing and skincare cosmetics. However, its active ingredients, such as saponins and alkaloids, often have skin irritant properties.

[0015] Artemisia annua is the above-ground part of Artemisia annua or Artemisia argyi or other plants of the same genus in the Asteraceae family. It is bitter and cold in nature; it enters the liver and gallbladder meridians. It is commonly used for summer heat syndrome, fever, anhidrosis, or febrile diseases, fever, chills, cold clearing with heat excess, as well as malaria and other symptoms.

[0016] Rehmannia glutinosa, also known as prepared rehmannia root or Fudi, is the tuberous root of the plant Rehmannia glutinosa (family Scrophulariaceae). It is processed and sweet, and slightly warm in nature. It enters the liver and kidney meridians, and its functions include nourishing blood and yin, replenishing essence and marrow. This herb is sweet, warm, and moistening, nourishing yin and replenishing essence to generate blood. It is an essential medicine for nourishing blood and replenishing deficiency, and is often used with Angelica sinensis, Paeonia lactiflora, and Ligusticum chuanxiong to treat blood deficiency, chlorosis, dizziness, and palpitations.

[0017] Panax notoginseng is the dried root of Panax notoginseng (Burk.) FH Chen, a plant belonging to the Araliaceae family. It has a sweet and slightly bitter taste, and is warm in nature. It disperses blood stasis, stops bleeding, reduces swelling, and relieves pain. It contains various active ingredients of dammarane-type tetracyclic triterpenoid saponins, such as ginsenosides and notoginsenosides.

[0018] The preferred weight proportions are: 1-10 parts ginseng, 5-20 parts astragalus, 10-60 parts arborvitae, 10-60 parts ginger, 1-8 parts soapberry, 5-25 parts artemisia annua, 5-40 parts rehmannia glutinosa, and 2-20 parts notoginseng.

[0019] The preferred weight proportions are: 1-10 parts ginseng, 5-20 parts astragalus, 10-60 parts arborvitae, 10-60 parts ginger, 2-7 parts soapberry, 5-25 parts artemisia annua, 5-40 parts rehmannia glutinosa, and 2-20 parts notoginseng.

[0020] The preferred weight proportions are: 2 parts ginseng, 10 parts astragalus, 30 parts arborvitae, 40 parts ginger, 5 parts soapberry, 15 parts artemisia annua, 20 parts rehmannia glutinosa, and 10 parts notoginseng.

[0021] The dosage form of the traditional Chinese medicine composition is selected from oral preparations or topical preparations.

[0022] The oral preparation is selected from one of granules, capsules, tablets, decoctions, mixtures, and pills;

[0023] The topical preparation is selected from one of the following: liniment, spray, patch, solution, lotion, tincture, and gel.

[0024] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition, wherein ginseng and Panax notoginseng are pulverized into coarse powder, and then the coarse powder of ginseng and Panax notoginseng is mixed with Astragalus membranaceus, Platycladus orientalis, ginger, Sapindus mukorossi, Artemisia annua and Rehmannia glutinosa, and then water or a lower alcohol or a mixed solvent of lower alcohol and water is added for extraction.

[0025] The preparation method further includes, after extraction, concentration, filtration, and addition of conventional excipients to prepare liniments, sprays, solutions, lotions, or tinctures.

[0026] The lower alcohol is selected from one or more of methanol, ethanol, propanol, and butanol, with ethanol being preferred.

[0027] The mixed solvent of the lower alcohol and water is selected from an alcohol solution of 40-90%, preferably an ethanol solution of 50%, 60%, 70%, or 80%, or preferably a n-butanol solution of 50%, 60%, 70%, 80%, or 90%.

[0028] The present invention also provides the above-described pharmaceutical uses, specifically the use of the traditional Chinese medicine composition in the preparation of products for the prevention or treatment of hair loss.

[0029] The hair loss is selected from androgenetic alopecia, seborrheic alopecia, alopecia areata, nutritional alopecia, or chemical alopecia. Seborrheic alopecia or androgenetic alopecia is preferred.

[0030] The use of the traditional Chinese medicine composition in the preparation of products that promote hair follicle formation and growth and increase the number of hair follicles.

[0031] The use of the traditional Chinese medicine composition in the preparation of hair growth products. Attached Figure Description

[0032] Figure 1 The effect of the traditional Chinese medicine compound of the present invention on the proliferation of hair follicle stem cells

[0033] Figure 2 The effect of the traditional Chinese medicine compound of this invention on hair growth in the bald area on the back of mice

[0034] Figure 3 The results of HE pathological staining of skin after administration of the traditional Chinese medicine compound of this invention

[0035] Figure 4 The bar chart of the effect of the traditional Chinese medicine compound on hair follicle growth in the hair removal area in this invention.

[0036] Beneficial effects: The traditional Chinese medicine composition of the present invention can effectively prevent or treat hair loss, especially seborrheic alopecia, while reducing skin irritation and improving safety of use. Detailed Implementation

[0037] The present invention will be further described below with reference to specific embodiments. Example

[0038] Take 20g ginseng, 100g astragalus, 300g arborvitae, 400g ginger, 50g soapberry, 150g artemisia annua, 200g rehmannia glutinosa, and 100g notoginseng. Grind the ginseng and notoginseng into coarse powder. Then mix the coarse powder with the astragalus, arborvitae, ginger, soapberry, artemisia annua, and rehmannia glutinosa. Add 15 times the amount of distilled water and soak for 20 minutes. Then heat and reflux to extract for 2 hours. Filter and collect the filtrate. Add 10 times the amount of distilled water to the residue and reflux to extract for 1.5 hours. Filter and collect the filtrate. Combine the filtrates and concentrate the liquid to 1g / ml to obtain the final product. Example

[0039] Take 50g of ginseng, 200g of astragalus, 300g of arborvitae, 200g of ginger, 30g of soapberry, 100g of artemisia annua, 300g of rehmannia glutinosa, and 200g of notoginseng. Grind the ginseng and notoginseng into coarse powder. Then mix the coarse powder with the astragalus, arborvitae, ginger, soapberry, artemisia annua, and rehmannia glutinosa. Add 12 times the amount of 70% ethanol and soak for 20 minutes. Then heat and reflux to extract for 2 hours. Filter and collect the filtrate. Add 10 times the amount of 70% ethanol to the residue and reflux to extract for 1.5 hours. Filter and collect the filtrate. Then combine the filtrates and recover the ethanol until there is no alcohol taste. Then add preservatives to make a liniment. Example

[0040] Take 30g of ginseng, 100g of astragalus, 200g of arborvitae, 500g of ginger, 20g of soapberry, 200g of artemisia annua, 100g of rehmannia glutinosa, and 200g of notoginseng. Grind the ginseng and notoginseng into coarse powder. Then mix the coarse powder with the astragalus, arborvitae, ginger, soapberry, artemisia annua, and rehmannia glutinosa. Add 10 times the amount of n-butanol and soak for 20 minutes. Then heat and reflux to extract for 1.5 hours. Filter and collect the filtrate. Add 8 times the amount of n-butanol to the residue and reflux to extract for 1 hour. Filter and collect the filtrate. Then combine the filtrates, recover some of the n-butanol under reduced pressure, concentrate, and then add preservatives to make a solution. Example

[0041] Take 10g of ginseng, 200g of astragalus, 500g of arborvitae, 200g of ginger, 60g of soapberry, 200g of artemisia annua, 100g of rehmannia glutinosa, and 200g of notoginseng. Grind the ginseng and notoginseng into coarse powder. Then mix the coarse powder with the astragalus, arborvitae, ginger, soapberry, artemisia annua, and rehmannia glutinosa. Add 12 times the amount of 60% ethanol and soak for 20 minutes. Then heat and reflux to extract for 1.5 hours. Filter and collect the filtrate. Add 10 times the amount of 60% ethanol to the residue and reflux to extract for 1 hour. Filter and collect the filtrate. Then combine the filtrates to make a tincture. Example

[0042] Take 10g of ginseng, 200g of astragalus, 100g of arborvitae, 200g of ginger, 50g of soapberry, 200g of artemisia annua, 300g of rehmannia glutinosa, and 100g of notoginseng. Grind the ginseng and notoginseng into coarse powder. Then mix the coarse powder with the astragalus, arborvitae, ginger, soapberry, artemisia annua, and rehmannia glutinosa. Add 12 times the amount of 60% ethanol and soak for 20 minutes. Then heat and reflux to extract for 1.5 hours. Filter and collect the filtrate. Add 10 times the amount of 60% ethanol to the residue and reflux to extract for 1 hour. Filter and collect the filtrate. Then combine the filtrates, recover the ethanol until there is no alcohol taste, concentrate, and then add hyaluronic acid to make a gel. Example

[0043] Take 10g of ginseng, 50g of astragalus, 500g of arborvitae, 200g of ginger, 60g of soapberry, 200g of artemisia annua, 100g of rehmannia glutinosa, and 60g of notoginseng. Grind the ginseng and notoginseng into coarse powder. Then mix the coarse powder with the astragalus, arborvitae, ginger, soapberry, artemisia annua, and rehmannia glutinosa. Add 12 times the amount of 60% ethanol and soak for 20 minutes. Then heat and reflux to extract for 1.5 hours. Filter and collect the filtrate. Add 10 times the amount of 60% ethanol to the residue and reflux to extract for 1 hour. Filter and collect the filtrate. Then combine the filtrates, recover the ethanol until there is no alcohol taste, concentrate, dry, grind through an 80-mesh sieve, and add starch and magnesium stearate to make granules.

[0044] Take 400g of fresh ginger, 150g of artemisia annua, and 200g of prepared rehmannia root. Mix the above Chinese herbs, add 15 times the amount of distilled water and soak for 20 minutes. Then heat and reflux to extract for 2 hours. Filter and collect the filtrate. Add 10 times the amount of distilled water to the residue and reflux to extract for 1.5 hours. Filter and collect the filtrate. Then combine the filtrates and concentrate the liquid to 1g / ml to obtain the final product.

[0045] Take 20g of ginseng, 100g of astragalus, and 400g of ginger. Grind the ginseng into coarse powder, then mix the coarse powder with the astragalus and ginger. Add 15 times the amount of distilled water and soak for 20 minutes. Then heat and reflux to extract for 2 hours. Filter and collect the filtrate. Add 10 times the amount of distilled water to the residue and reflux to extract for 1.5 hours. Filter and collect the filtrate. Combine the filtrates and concentrate the liquid to 1g / ml to obtain the final product.

[0046] Take 20g of ginseng, 100g of angelica, 300g of arborvitae, 400g of ginger, 50g of soapberry, 150g of phellodendron bark, 100g of sophora flavescens, and 100g of notoginseng. Grind the ginseng and notoginseng into coarse powder. Then mix the coarse powder with angelica, arborvitae, ginger, soapberry, phellodendron bark, and sophora flavescens. Add 15 times the amount of distilled water and soak for 20 minutes. Then heat and reflux to extract for 2 hours. Filter and collect the filtrate. Add 10 times the amount of distilled water to the residue and reflux to extract for 1.5 hours. Filter and collect the filtrate. Then combine the filtrates and concentrate the liquid to 1g / ml to obtain the final product.

[0047] Take 20g of ginseng, 100g of astragalus, 300g of arborvitae, 400g of ginger, 50g of soapberry, 200g of rehmannia, and 100g of notoginseng. Grind the ginseng and notoginseng into coarse powder. Then mix the coarse powder with the astragalus, arborvitae, ginger, soapberry, and rehmannia. Add 15 times the amount of distilled water and soak for 20 minutes. Then heat and reflux to extract for 2 hours. Filter and collect the filtrate. Add 10 times the amount of distilled water to the residue and reflux to extract for 1.5 hours. Filter and collect the filtrate. Combine the filtrates and concentrate the liquid to 1g / ml to obtain the final product.

[0048] Experimental protocol: Hair follicle stem cells (HFSCs) were prepared at a ratio of 8 × 10⁻⁶. 4 The cells were seeded at a density of 10 μg / mL into 96-well plates and cultured in complete culture medium. After incubation for 24 h, the culture medium was removed from each well. The cells were then treated with four different traditional Chinese medicine compound concentrations of 10 μg / mL and 25 μg / mL for 24 h. CCK-8 solution was added, and the absorbance at 450 nm was measured using an ELISA reader. The effect on the proliferation of hair follicle stem cells was then calculated.

[0049] The results showed that, at the same dosage concentrations of 10 μg / mL and 25 μg / mL, the traditional Chinese medicine compound of the present invention had a significant proliferative effect on hair follicle stem cells. The traditional Chinese medicine compound of Comparative Examples 2 and 3 also had a certain proliferative effect on hair follicle stem cells, while the traditional Chinese medicine compound of Comparative Example 1 only had a certain proliferative effect at 25 μg / mL. Moreover, the results showed that the traditional Chinese medicine compound of the present invention had a significantly improved proliferative effect on hair follicle stem cells compared with the compound of Comparative Examples 1-3.

[0050] in Figure 1The left and right graphs show the results for a compound concentration of 10 μg / mL and 25 μg / mL, respectively. Formulas 1-4 correspond to the traditional Chinese medicine compositions of proportions 1-3 and Example 1, respectively, while 0 represents the control group.

[0051] Thirty-five 6-week-old male C57BL / 6 mice, weighing 20±2g, were used for the experiment after one week of acclimatization.

[0052] Dihydrotestosterone (DHT) powder, corn oil for injection, 5% minoxidil tincture, rosin, paraffin, compound solution, and physiological saline.

[0053] A total of 7 groups were set up: blank group, model group, formula 1, formula 2, formula 3, formula 4, and minoxidil positive group, with 5 animals in each group. Formulas 1 to 4 are the traditional Chinese medicine compositions of comparative examples 1-3 and example 1, respectively.

[0054] Rosin and paraffin were mixed in a 1:1 ratio and placed in a beaker. The mixture was heated until it reached a liquid state and applied to the area on the back of mice to be treated (approximately 2×3 cm). After cooling, the mixture was removed to complete the hair removal. Except for the control group, the other six groups were used to establish an AGA model by subcutaneously injecting 0.1 ml of diluted DHT solution at a dose of 5 mg / kg / day (the skin on the back of the mouse's neck was pinched between the thumb and forefinger, and the needle was inserted horizontally for subcutaneous injection). Based on the human / mouse body area conversion, the control group and model group were treated with 0.3 ml of physiological saline, the formula group was treated with an equal dose of the drug solution diluted with physiological saline (containing 0.036 g of raw drug), and the positive control group was treated with 0.3 ml of minoxidil tincture.

[0055] From day 0 until the end of day 9 of drug administration, the hair growth in the bald areas on the backs of mice was recorded by photographing on days 0, 3, 6, and 9. The results are as follows: Figure 2 As shown, the skin of the compound four group turned gray earlier than the other three groups. On the ninth day, the skin color of the back of the mice turned significantly gray, indicating that the compound four can induce hair follicles to enter the growth phase earlier.

[0056] After the experiment, skin samples from the treatment area on the back were taken for HE pathological staining, and the number of hair follicles was counted. The results are as follows: Figure 3 , 4 As shown, compared with the blank control group, the number of hair follicles in the model group was significantly reduced; compared with the model group and comparative groups 1-3, the compound four (Example 1 of this invention) group significantly increased the number of hair follicles in DHT-induced androgenic alopecia mice.

[0057] Skin irritation test

[0058] According to the skin irritation test method in the "Cosmetic Safety Technical Specifications", 10 guinea pigs were randomly divided into two groups of 5 each. Approximately 24 hours before the test, the hair on both sides of the spine on the back of the experimental animals was shaved, taking care not to damage the skin. The shaved area was approximately 3cm × 3cm on each side. Experimental Group 1: The drug solution prepared in Example 1 was applied directly to the skin, with the other side of the skin serving as a control. Experimental Group 2: The drug solution prepared in Comparative Example 4 (with the same concentration and dosage as Experimental Group 1) was applied directly to the skin, with the other side of the skin serving as a control. Irritation and erythema were observed at 1, 24, 48, and 72 hours after administration. Skin irritation was assessed using the Draize scale, and the sum of the stimulation scores from 0 to 4 for each group was calculated to evaluate skin irritation. The results are shown in Table 1.

[0059] Table 1 Results of skin irritation test

[0060] The results showed that the traditional Chinese medicine composition of the present invention had low skin irritation, and compared with traditional Chinese medicine compositions that did not contain Artemisia annua, it had even lower skin irritation. In group 2, mild erythema was observed in two guinea pigs after 1 hour, and after 24 hours, mild erythema was observed in two more guinea pigs, while one guinea pig showed obvious erythema.

Claims

1. A traditional Chinese medicine composition for the prevention or treatment of seborrheic alopecia, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 1-10 parts ginseng, 5-20 parts astragalus, 10-60 parts arborvitae, 10-60 parts ginger, 1-8 parts soapberry, 5-25 parts artemisia annua, 5-40 parts rehmannia glutinosa, and 2-20 parts notoginseng. The preparation method of the traditional Chinese medicine composition is as follows: Ginseng and Panax notoginseng are crushed into coarse powder, and then the coarse powder of ginseng and Panax notoginseng is mixed with Astragalus membranaceus, Platycladus orientalis, ginger, Sapindus mukorossi, Artemisia annua and Rehmannia glutinosa, and then extracted with water or a lower alcohol or a mixed solvent of lower alcohol and water.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The ingredients are in the following proportions by weight: ginseng 1-10 parts, astragalus 5-20 parts, arborvitae 10-60 parts, ginger 10-60 parts, soapberry 2-7 parts, artemisia annua 5-25 parts, rehmannia glutinosa 5-40 parts, and notoginseng 2-20 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that: The ingredients are in the following proportions by weight: ginseng 2 parts, astragalus 10 parts, arborvitae 30 parts, ginger 40 parts, soapberry 5 parts, artemisia annua 15 parts, rehmannia glutinosa 20 parts, and notoginseng 10 parts.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that: The dosage form of the traditional Chinese medicine composition is selected from external preparations.

5. The traditional Chinese medicine composition according to claim 4, characterized in that: The topical preparation is selected from one of the following: liniment, spray, patch, solution, lotion, tincture, and gel.

6. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that: Ginseng and Panax notoginseng are crushed into coarse powder. Then, the coarse powder of ginseng and Panax notoginseng is mixed with Astragalus membranaceus, Platycladus orientalis, ginger, Sapindus mukorossi, Artemisia annua, and Rehmannia glutinosa. The mixture is then extracted with water or a lower alcohol or a mixture of lower alcohol and water.

7. The preparation method according to claim 6, characterized in that: The lower alcohol is selected from one or more of methanol, ethanol, propanol, and butanol.

8. The preparation method according to claim 7, characterized in that: The lower alcohol is selected from ethanol.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of products for the prevention or treatment of seborrheic alopecia.

Images