An external-use traditional Chinese medicine composition for preventing and treating alopecia, and a preparation method and use thereof

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a topical traditional Chinese medicine composition for preventing and treating hair loss, its preparation method, and its uses. The composition consists of eight ingredients that, according to Chinese regulations, can be added to cosmetics: Artemisia argyi, chrysanthemum, Clematis armandii, Schizonepeta tenuifolia, Saposhnikovia divaricata, peppermint, Patchouli, and Nardostachys jatamansi. This composition can reduce dandruff by inhibiting harmful bacteria on the scalp; improve the scalp's water-oil balance and reduce excessive sebum secretion; reduce inflammation and alleviate scalp itching; and promote hair growth, thus improving hair loss. The preparation method of this topical traditional Chinese medicine composition is simple, and it can be easily added to scalp topical medications, scalp care essences, shampoos, and other product forms for consumer convenience.

Description

Technical Field

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

[0002] Hair loss, or hair shedding, includes both physiological and pathological hair loss. Physiologically, hair follicles on the scalp undergo cyclical growth, consisting of three phases: anagen (growth), catagen (transitional), and telogen (resting). Under normal circumstances, the number of hairs entering the anagen and telogen phases is relatively balanced with the number entering the anagen phase. Losing 100-150 hairs per day is considered normal physiological metabolism and is called physiological hair loss. However, factors such as medication side effects, environmental factors, psychological factors, and postpartum can disrupt the normal hair growth cycle, breaking this balance and causing hair loss far exceeding the normal range, thus becoming pathological hair loss. There are many types of hair loss, the most common being androgenetic alopecia and alopecia areata.

[0003] Androgenetic alopecia is a progressive hair loss disorder characterized by the miniaturization of hair follicles that begins in or after puberty. It can affect both men and women, but presents with different patterns and prevalence rates. In my country, the prevalence is approximately 21.3% in men and 6.0% in women. Treatment methods for androgenetic alopecia include systemic medication, topical medication, hair transplantation, and low-energy laser therapy. Among drug treatments, finasteride is only suitable for male patients, with an effectiveness rate of 65%-90% after one year of use. Some patients may experience decreased prostate-specific antigen (PSA), gynecomastia, testicular pain, allergic reactions, and impaired sexual function. Spironolactone is only suitable for some female patients, requiring at least one year of use to be effective. Major adverse reactions include menstrual irregularities, decreased libido, and breast tenderness. Minoxidil is a topical medication; a 5% concentration is recommended for men and a 2% concentration for women. The average time to see results is 6-9 months, with an effectiveness rate of 50%-85%. Some patients may experience hirsutism, irritant dermatitis, and allergic dermatitis, which usually subside after discontinuation of the medication.

[0004] Alopecia areata is a common inflammatory non-scarring hair loss that can occur at any age, but is more common in young and middle-aged adults. There is no significant gender difference. Most mild cases resolve spontaneously, but about half of the patients experience recurrent episodes, which can last for years or even decades. Treatment primarily involves topical corticosteroids, the main medication for mild to moderate alopecia areata. If no improvement is seen after 3-4 months of treatment, the treatment plan should be adjusted. Adverse reactions mainly include skin atrophy and yellowing, telangiectasia, folliculitis, and hypopigmentation; most of these symptoms resolve after discontinuation of the medication. Intralesional corticosteroid injection is the preferred treatment for patients with smaller areas of hair loss in the stable phase. If no hair growth is observed within 3 months, injections should be discontinued. Adverse reactions mainly include local skin atrophy, folliculitis, and hypopigmentation; most of these symptoms resolve spontaneously. Local immunotherapy can be used for severe cases and is suitable for those with a long disease course or those who have not responded well to other treatments. Treatment should be continued for at least 3-6 months before evaluating efficacy; the effectiveness rate is approximately 30%-50%. Adverse reactions are more numerous, mainly contact dermatitis, lymphadenopathy, pigmentation, fever, and vitiligo.

[0005] Traditional Chinese medicine refers to hair loss as "insect-eaten hair loss," "hair-eating tinea," or "oil wind," believing it is often related to liver and kidney deficiency, qi and blood deficiency, weak pores, and invasion of wind pathogens, leading to dryness of the blood and malnourishment of the hair. It is also attributed to emotional distress, disharmony of qi and blood, and obstruction of blood flow, resulting in insufficient blood nourishment of the hair. Traditional Chinese medicine often employs methods to tonify the kidneys, nourish the blood, promote blood circulation, and cool the blood. In addition to oral medications such as Yangxue Shengfa capsules and Bantu pills, external treatments of Chinese medicine have a long history in treating hair loss. Clinically, external treatments are often combined with internal treatments. Furthermore, tinctures can be prepared and applied to the affected area for massage, or decoctions can be used for soaking and fumigating the hair.

[0006] Chinese Patent 202010604636.X discloses a traditional Chinese medicine shampoo for preventing and treating seborrheic alopecia. The main ingredients include Sophora flavescens, Angelica dahurica, Arctium lappa, Saposhnikovia divaricata, Kochia scoparia, Ligustrum lucidum, Angelica sinensis, Dipsacus asper, Polygonum multiflorum, Eclipta prostrata, Cinnamomum cassia, Magnolia officinalis, Psoralea corylifolia, Aconitum carmichaelii, Achyranthes bidentata, Paeonia lactiflora, Morus alba leaves, Citrus reticulata peel, Artemisia argyi, Chrysanthemum morifolium, Ligusticum striatum, Schizonepeta tenuifolia, Pogostemon cablin, and Nardostachys chinensis. The preparation method involves boiling the aforementioned main ingredients in water, filtering, and allowing it to stand. The supernatant is then added to other ingredients such as cocamidopropyl betaine to make a shampoo. Chinese Patent 202210714479.X discloses an oil-controlling and hair loss-preventing composition, including Zingiber officinale root, Ligustrum lucidum, Rehmannia glutinosa root, Polygonum multiflorum, sesame, ginseng root, Eclipta prostrata, Platycladus orientalis leaves, diaminopyrimidine oxide, and adenosine. The preparation method includes the following steps: water extraction, filtration, and concentration. Chinese Patent 202210783845.7 discloses a traditional Chinese medicine composition for treating hair loss and promoting hair growth, comprising Gynostemma pentaphyllum, Astragalus membranaceus, mulberry leaf, raspberry, Angelica sinensis, white peony root, cinnamon twig, earthworm, Eupolyphaga sinensis, Notopterygium incisum, Atractylodes lancea, Ephedra sinica, and Strychnos nux-vomica. The preparation process involves pulverizing, ethanol extraction, concentration, and then adding excipients to form a topical formula. Chinese Patent 202211045464.5 discloses a topical traditional Chinese medicine composition for preventing hair loss and its preparation method, comprising Sophora flavescens, Dictamnus dasycarpus, Kochia scoparia, Platycladus orientalis leaf, mulberry leaf, Smilax glabra, Stemona japonica, Pinellia ternata, Acorus tatarinowii, Atractylodes lancea, Ligusticum chuanxiong, Angelica sinensis, Spatholobus suberectus, Carthamus tinctorius, Paeonia suffruticosa, Paeonia lactiflora, Lithospermum erythrorhizon, Saposhnikovia divaricata, Notopterygium incisum, Vitex trifolia, Angelica dahurica, Plantago asiatica, Alisma plantago-aquatica, Eclipta prostrata, Polygonum multiflorum, Bupleurum chinense, cinnamon twig, dried ginger, Zanthoxylum bungeanum, Psoralea corylifolia, Epimedium brevicornu, Glycyrrhiza uralensis, and Mentha haplocalyx. The preparation method involves extraction with alcohol of a certain concentration. However, the above preparation methods have various problems, such as the use of a large number of medicinal ingredients, complex preparation processes, poor efficacy, and slow onset of action.

[0007] Therefore, there is still a significant market demand for topical Chinese medicine preparations for preventing and treating hair loss that are effective, fast-acting, simple to prepare, and low in cost. Summary of the Invention

[0008] The purpose of this invention is to address the shortcomings of existing technologies by providing a topical Chinese medicine composition for preventing and treating hair loss, along with its preparation method and uses, targeting the traditional Chinese medicine pathogenesis of hair loss. The composition consists of eight ingredients that are permitted for use in cosmetics according to Chinese regulations. This composition can reduce dandruff by inhibiting harmful bacteria on the scalp; improve the scalp's oil-water balance and reduce excessive sebum secretion; reduce inflammation and alleviate scalp itching; and promote hair growth, thus improving hair loss. The preparation method of this topical Chinese medicine composition is simple, and it can be easily added to scalp topical medications, scalp care serums, shampoos, and other product forms for consumer convenience.

[0009] Specifically, the present invention is achieved through the following technical solutions:

[0010] In a first aspect, the present invention provides a topical Chinese medicine composition for preventing and treating hair loss, wherein, by weight, the Chinese medicine composition comprises 2-8 parts of Artemisia argyi, 2-8 parts of Chrysanthemum morifolium, 2-8 parts of Clematis armandii, 2-8 parts of Schizonepeta tenuifolia, 2-8 parts of Saposhnikovia divaricata, 4-16 parts of Mentha haplocalyx, 2-8 parts of Pogostemon cablin, and 2-8 parts of Nardostachys jatamansi.

[0011] As an optional method, the above-mentioned external Chinese medicine composition, by weight, includes 4-6 parts of Artemisia argyi, 4-6 parts of Chrysanthemum, 4-6 parts of Clematis armandii, 4-6 parts of Schizonepeta tenuifolia, 4-6 parts of Saposhnikovia divaricata, 8-12 parts of Mentha haplocalyx, 4-6 parts of Pogostemon cablin, and 4-6 parts of Nardostachys jatamansi.

[0012] As an optional method, the above-mentioned external Chinese medicine composition, by weight, includes 6 parts of Artemisia argyi, 6 parts of Chrysanthemum, 6 parts of Clematis armandii, 6 parts of Schizonepeta tenuifolia, 6 parts of Saposhnikovia divaricata, 12 parts of Mentha haplocalyx, 6 parts of Pogostemon cablin, and 6 parts of Nardostachys jatamansi.

[0013] Alternatively, in the above-mentioned external application traditional Chinese medicine composition, the traditional Chinese medicine composition is made from mugwort, chrysanthemum, nine-section tea, schizonepeta, saposhnikovia, peppermint, patchouli, and nard.

[0014] Artemisia argyi is a plant belonging to the Artemisia genus of the Asteraceae family. The whole plant is used medicinally and has various effects such as warming the meridians, dispelling dampness, dispersing cold, stopping bleeding, reducing inflammation, relieving asthma, stopping cough, and calming the fetus. When used externally, it can dispel dampness and relieve itching.

[0015] Chrysanthemum is the dried capitulum of the chrysanthemum plant in the Asteraceae family. It has the effects of dispelling wind and clearing heat, calming the liver and improving eyesight, and clearing heat and detoxifying.

[0016] Nine-section tea refers to the above-ground parts of *Sarcandra glabra*, a plant belonging to the genus *Sarcandra* in the family Chloranthus. It has the functions of dispelling wind and promoting blood circulation, clearing heat and detoxifying.

[0017] Catnip is the dried aerial part of the catnip plant (Nepeta cataria), belonging to the Lamiaceae family. It has the functions of relieving exterior syndromes, dispelling wind, promoting rash eruption, and eliminating sores.

[0018] Saposhnikovia root is the dried root of Saposhnikovia divaricata, a plant in the Apiaceae family. It has the functions of dispelling wind and relieving exterior syndromes, promoting diuresis and relieving pain, and stopping spasms.

[0019] Peppermint is the dried aerial part of the peppermint plant (Mentha haplocalyx), belonging to the Lamiaceae family. It has the functions of dispersing wind-heat, clearing the head and eyes, relieving sore throat, promoting rash eruption, and soothing the liver and regulating qi.

[0020] Patchouli is the dried whole herb of *Pogostemon cablin*, belonging to the genus *Pogostemon* in the family Lamiaceae. It has the functions of relieving summer heat, dispelling exterior syndromes, resolving dampness, and harmonizing the stomach.

[0021] Nardostachys jatamansi is the dried root and rhizome of the plant Nardostachys jatamansi, belonging to the Valerianaceae family. It has the functions of regulating qi and relieving pain, relieving stagnation and invigorating the spleen; externally, it is used to dispel dampness and reduce swelling.

[0022] In a second aspect, the present invention also provides a method for preparing the topical Chinese medicine composition described in the first aspect above, the method comprising the following steps:

[0023] (1) Weigh out the following ingredients in proportion: mugwort leaves, chrysanthemum, nine-section tea, schizonepeta, saposhnikovia, mint, patchouli, and nard, and coarsely crush them for later use;

[0024] (2) Put the coarse powder of the medicinal material into a steam distillation extraction device, add 10-20 times the amount of water of the medicinal material, soak overnight, so that the medicinal material can fully absorb water and be moistened;

[0025] (3) Heat to boiling, then reduce the heating temperature to 80℃-100℃ and maintain it for 4-8 hours. Collect the condensate to obtain aromatic water.

[0026] (4) Filter the residue, collect the filtrate, and obtain the extract.

[0027] Alternatively, in the above preparation method, the preparation method includes the following steps:

[0028] (1) Weigh out the following ingredients in proportion: mugwort leaves, chrysanthemum, nine-section tea, schizonepeta, saposhnikovia, mint, patchouli, and nard, and coarsely crush them for later use;

[0029] (2) Put the coarse powder of the medicinal material into a steam distillation extraction device, add 16 times the amount of water of the medicinal material, soak overnight, so that the medicinal material can fully absorb water and be moistened.

[0030] (3) Heat to boiling, then reduce the heating temperature to 85°C and maintain for 6 hours. Collect the condensate to obtain aromatic water.

[0031] (4) Filter the residue, collect the filtrate, and obtain the extract.

[0032] Alternatively, in the above preparation method, the amount of aromatic water and the amount of extract added to the external Chinese medicine composition are 10-80% by weight percentage.

[0033] Alternatively, in the above preparation method, the amount of aromatic water and the amount of extract added to the external Chinese medicine composition are 30-60% by weight percentage.

[0034] Alternatively, in the above preparation method, the amount of aromatic water added to the external Chinese medicine composition is 45% by weight, and the amount of extract added is 55%.

[0035] In a third aspect, the present invention provides the use of the topical Chinese medicine composition described in the first aspect above, or the topical Chinese medicine composition prepared by the preparation method described in the second aspect above, in the preparation of topical products for the prevention and treatment of hair loss.

[0036] Alternatively, in the above-mentioned uses, the topical product may be a medicine, cosmetic, or personal care product.

[0037] Alternatively, in the above-mentioned uses, the topical product is a gel, ointment, cream, foam, shampoo, conditioner, or spray-type liquid formulation.

[0038] Alternatively, in the above-mentioned uses, the hair loss is one or more of the following: androgenetic alopecia, neurogenic alopecia, endocrine alopecia, nutritional alopecia, physical alopecia, chemical alopecia, infectious alopecia, congenital alopecia, and seasonal alopecia.

[0039] Alternatively, in the above-described uses, the topical product enhances the activity of hair follicle tissue, prompting resting hair follicles to enter a regeneration cycle and promoting hair growth.

[0040] It should be understood that, within the scope of this invention, the above-described technical features of this invention and the technical features specifically described below (such as in the embodiments) can be combined with each other to form new or preferred technical solutions. Due to space limitations, they will not be described in detail here.

[0041] Compared with the prior art, the present invention has the following advantages:

[0042] (1) This invention is a topical Chinese medicine composition with readily available ingredients and high safety, based on the theory of the pathogenesis of hair loss in traditional Chinese medicine.

[0043] (2) The topical Chinese medicine composition of the present invention can reduce dandruff by inhibiting harmful bacteria on the scalp; improve the water-oil balance of the scalp and reduce excessive secretion of scalp oil; reduce inflammation and improve the scalp inflammation state and relieve scalp itching; promote hair growth and improve hair loss.

[0044] (3) The preparation method of the topical Chinese medicine composition of the present invention is simple, and it can be conveniently added to the form of scalp topical medicine, scalp care essence, shampoo and other products to facilitate consumer use. Detailed Implementation

[0045] The preferred embodiments of the present invention are described below. It should be understood that the preferred embodiments described herein are for illustration and explanation only and are not intended to limit the present invention. Where specific techniques or conditions are not specified in the embodiments, they shall be performed in accordance with the techniques or conditions described in the literature in the art, or in accordance with the product instructions. Where the manufacturers of the reagents or instruments used are not specified, they are all conventional products that can be purchased through legitimate channels.

[0046] Preparation Example:

[0047] Example 1

[0048] In a topical Chinese medicine composition for preventing and treating hair loss, the composition is made from 6 parts of Artemisia argyi, 6 parts of Chrysanthemum morifolium, 6 parts of Clematis armandii, 6 parts of Schizonepeta tenuifolia, 6 parts of Saposhnikovia divaricata, 12 parts of Mentha haplocalyx, 6 parts of Pogostemon cablin, and 6 parts of Nardostachys jatamansi, by weight.

[0049] The preparation method includes the following steps:

[0050] (1) Weigh out the following ingredients in proportion: mugwort leaves, chrysanthemum, nine-section tea, schizonepeta, saposhnikovia, mint, patchouli, and nard, and coarsely crush them for later use;

[0051] (2) Put the coarse powder of the medicinal material into a steam distillation extraction device, add 16 times the amount of water of the medicinal material, soak overnight, so that the medicinal material can fully absorb water and be moistened.

[0052] (3) Heat to boiling, then reduce the heating temperature to 85°C and maintain for 6 hours. Collect the condensate to obtain aromatic water.

[0053] (4) Filter the residue, collect the filtrate, and obtain the extract.

[0054] In the above-mentioned topical Chinese medicine composition, the amount of aromatic water added is 45% by weight, and the amount of extract added is 55%.

[0055] Example 2

[0056] This embodiment provides a shampoo for preventing hair loss, which includes the following components by weight percentage:

[0057] The topical Chinese medicine composition obtained in Example 1 contains 60% sodium lauryl ether sulfate, 16.5% cocamidopropyl betaine, 5% cocoyl glucoside, 4% cocamide, 2.5% glycerin, 2% polyquaternium-7, 0.8% fragrance, 0.5% PEG-7 glyceryl cocoate, 0.5% trehalose, 0.5% betaine, 0.3% sodium chloride, and 0.3% hydantoin.

[0058] The above-mentioned shampoo is processed as follows: the solid raw materials are dissolved and filtered, the filtrate is added together with other liquid raw materials to the extract and aromatic water of the composition, and then stirred and homogenized in an emulsification tank before being packaged.

[0059] Compare with Example 1

[0060] This comparative example was prepared according to the method of Example 1, except that 6 parts of Vitex trifolia fruit were used instead of 6 parts of Chrysanthemum in the raw materials.

[0061] Compare with Example 2

[0062] This comparative example was prepared according to the method of Example 1, except that 6 parts of Vitex trifolia were used instead of 6 parts of Chrysanthemum in the raw materials, and 6 parts of peppermint were used.

[0063] Compare with Example 3

[0064] This comparative example was prepared according to the method of Example 1, except that 6 parts of Vitex trifolia were used instead of 6 parts of Clematis chinensis in the raw materials, 6 parts of peppermint were used, and 6 parts of Ligusticum striatum were added.

[0065] Compare with Example 4

[0066] This comparative example was prepared according to the method of Example 1. However, only aromatic water was used in the external Chinese medicine composition.

[0067] Compare with Example 5

[0068] This comparative example was prepared according to the method of Example 1. However, only the extract was used in the external application traditional Chinese medicine composition.

[0069] Example of effect:

[0070] Experimental Example 1:

[0071] The purpose of this experiment is to investigate the inhibitory effect of aromatic water and extract in the topical Chinese medicine composition prepared in Example 1 on Malassezia, so as to determine its dandruff-removing efficacy.

[0072] Test method:

[0073] 1) Pre-culture the bacterial strain to prepare Malassezia furfural plates.

[0074] 2) Add aromatic water and extract to sterile filter paper respectively, and let them air dry.

[0075] 3) Use tweezers to place the filter paper onto the Malassezia agar plate.

[0076] 4) Place the prepared Malassezia furfur agar plates into an incubator and incubate at 30 degrees Celsius for 3-7 days.

[0077] 5) Measure the diameter of the inhibition zone against Malassezia furfur using a ruler.

[0078] Basis for result determination:

[0079] If the diameter of the inhibition zone of the test sample is greater than 7 mm, it has an antibacterial effect and is judged to have dandruff removal efficacy; if the diameter of the inhibition zone is not greater than 7 mm, it does not have an antibacterial effect and is judged to have no dandruff removal efficacy.

[0080] result:

[0081] The diameter of the inhibition zone of both the aromatic water and the extract in the aforementioned composition is greater than 7 mm, indicating that both the aromatic water and the extract have antibacterial effects. It was determined that the aromatic water and the extract obtained from the aforementioned composition via steam distillation both have anti-dandruff efficacy. Furthermore, it was found that the diameter of the inhibition zone significantly increased after combining the aromatic water and the extract, suggesting that the combination of aromatic water and the extract may have produced a significant synergistic effect in antibacterial efficacy.

[0082] Experimental Example 2:

[0083] Healthy adults who reported oily hair, dandruff, itchy scalp, and hair loss were recruited to participate in a product trial. Those who lost more than 10 hairs after 60 hair combing exercises participated in the trial. Each group consisted of 10 people. They used the shampoo prepared according to the method described in Example 2 (Example 1, Control Example 1, Control Example 2, Control Example 3, Control Example 4, and Control Example 5) to wash their hair every other day for 12 weeks.

[0084] Self-evaluation of oiliness, dandruff, and scalp itching was conducted before use and at 4, 8, and 12 weeks after use. A 60-comb test was performed, and the number of hairs lost was calculated. At the end of the trial, if less than 10 hairs were lost after 60 combing tests, and there was almost no oiliness, dandruff, or itching, the patient was considered cured. If the number of hairs lost was reduced by half or more compared to the initial amount, and there was a significant reduction in oiliness, dandruff, and itching, the patient was considered significantly effective. If the number of hairs lost was reduced by one-third, and there was some reduction in oiliness, dandruff, and itching, the patient was considered effective. If there was no significant reduction in the number of hairs lost, and there was little change in oiliness, dandruff, or itching, the patient was considered ineffective. The overall effective rate was calculated as (cured + significantly effective + effective) / total number of cases × 100%.

[0085] Table 1: Improvement in the amount of hair loss in each group of trial participants

[0086]

[0087]

[0088] As shown in Table 1, in terms of the improvement in the amount of hair loss, the shampoo prepared by the topical Chinese medicine composition made of a specific ratio of extract and aromatic water provided by the present invention can more effectively reduce the amount of hair loss compared with the two control examples (Control Example 4 and Control Example 5) that only use aromatic water or extract. The total effective rate of Example 1 can reach 100%, which shows that the components of aromatic water and extract may have a significant synergistic effect on hair loss.

[0089] Furthermore, as can be seen from the data of Comparative Examples 1-3, when certain components in the topical Chinese medicine composition of the present invention are added, subtracted, or replaced, or their dosage ratio is changed, the efficacy of the topical Chinese medicine composition significantly deteriorates. Therefore, it is shown that the types and dosage ratios of each herb in the Chinese medicine composition are crucial to the efficacy of the topical Chinese medicine composition of the present invention.

[0090] Table 2: Improvement in oiliness among different trial groups

[0091] Group get well Effective efficient invalid Overall efficiency Example 1 4(40％) 4(40％) 2(20％) 0 10(100％) Compare with Example 1 1(10％) 4(40％) 3(30％) 2(20％) 8(80％) Compare with Example 2 0 4(40％) 4(40％) 2(20％) 8(80％) Compare with Example 3 0 3(30％) 4(40％) 3(30％) 7(70％) Compare with Example 4 1(10％) 4(40％) 3(30％) 2(20％) 8(80％) Compare with Example 5 0 3(30％) 4(40％) 3(30％) 7(70％)

[0092] As shown in Table 2, in terms of the improvement of oiliness, the shampoo prepared by the external Chinese medicine composition made of a specific ratio of extract and aromatic water provided by the present invention can more effectively reduce oiliness compared with the two control examples (control examples 4 and 5) that only use aromatic water or extract. The total effective rate of Example 1 can reach 100%, which shows that the degreasing effect of the components of aromatic water and extract may have produced a significant synergistic effect.

[0093] Furthermore, as can be seen from the data of Comparative Examples 1-3, when certain components in the topical Chinese medicine composition of the present invention are added, subtracted, or replaced, or their dosage ratio is changed, the efficacy of the topical Chinese medicine composition significantly deteriorates. Therefore, it is shown that the types and dosage ratios of each herb in the Chinese medicine composition are crucial to the efficacy of the topical Chinese medicine composition of the present invention.

[0094] Table 3: Improvement in dandruff in each trial group

[0095] Group get well Effective efficient invalid Overall efficiency Example 1 8(80％) 2(20％) 0 0 10(100％) Compare with Example 1 4(40％) 3(30％) 2(20％) 1(10％) 9(90％) Compare with Example 2 3(30％) 3(30％) 3(30％) 1(10％) 9(90％) Compare with Example 3 4(40％) 3(30％) 1(10％) 2(20％) 8(80％) Compare with Example 4 5(50％) 3(30％) 1(10％) 1(10％) 9(90％) Compare with Example 5 3(30％) 4(40％) 1(10％) 2(20％) 8(80％)

[0096] As shown in Table 3, in terms of dandruff improvement, each experimental group had a good effect on improving dandruff in the trial population, and the total effective rate of each experimental group was over 80%.

[0097] The shampoo formulated with a topical traditional Chinese medicine composition of extract and aromatic water provided by this invention is more effective in reducing dandruff than two control examples (Control Example 4 and Control Example 5) that used only aromatic water or extract. The total effective rate of Example 1 can reach 100%, indicating that the anti-dandruff effects of the aromatic water and extract components may have a significant synergistic effect. Furthermore, it can be seen that the anti-dandruff effect of the aromatic water component may be superior to that of the extract component.

[0098] Furthermore, as can be seen from the data of Comparative Examples 1-3, when certain components in the topical Chinese medicine composition of the present invention are added, subtracted, or replaced, or their dosage ratio is changed, the efficacy of the topical Chinese medicine composition significantly deteriorates. Therefore, it is shown that the types and dosage ratios of each herb in the Chinese medicine composition are crucial to the efficacy of the topical Chinese medicine composition of the present invention.

[0099] Table 4: Improvement of scalp itching in each trial group

[0100] Group get well Effective efficient invalid Overall efficiency Example 1 10(100％) 0 0 0 10(100％) Compare with Example 1 6(60％) 4(40％) 0 0 10(100％) Compare with Example 2 6(60％) 3(30％) 1(10％) 0 10(100％) Compare with Example 3 6(60％) 4(40％) 0 0 10(100％) Compare with Example 4 8(80％) 2(20％) 0 0 10(100％) Compare with Example 5 6(60％) 3(30％) 1(10％) 0 10(100％)

[0101] As shown in Table 4, in terms of the improvement of scalp itching, each experimental group had a good effect on improving scalp itching in the trial population, and the total effective rate of each experimental group was 100%.

[0102] The shampoo formulated with a topical traditional Chinese medicine composition of extract and aromatic water provided by this invention is more effective in improving scalp itching than two control examples (Control Example 4 and Control Example 5) that used only aromatic water or extract. The cure rate in Example 1 was 100%, indicating that the aromatic water and extract components may have a significant synergistic effect in improving scalp itching. Furthermore, it can be seen that the aromatic water component may be more effective than the extract component in improving scalp itching.

[0103] Furthermore, as can be seen from the data of Comparative Examples 1-3, when certain components in the topical Chinese medicine composition of the present invention are added, subtracted, or replaced, or their dosage ratio is changed, the efficacy of the topical Chinese medicine composition significantly deteriorates. Therefore, it is shown that the types and dosage ratios of each herb in the Chinese medicine composition are crucial to the efficacy of the topical Chinese medicine composition of the present invention.

[0104] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A topical traditional Chinese medicine composition for preventing and treating hair loss, characterized in that: By weight, the traditional Chinese medicine composition comprises 4-6 parts of Artemisia argyi, 4-6 parts of Chrysanthemum morifolium, 4-6 parts of Clematis armandii, 4-6 parts of Schizonepeta tenuifolia, 4-6 parts of Saposhnikovia divaricata, 8-12 parts of Mentha haplocalyx, 4-6 parts of Pogostemon cablin, and 4-6 parts of Nardostachys jatamansi. The preparation method of the traditional Chinese medicine composition includes the following steps: (1) Weigh out the following ingredients according to the proportions: mugwort leaves, chrysanthemum, nine-section tea, schizonepeta, saposhnikovia, mint, patchouli, and nard, and coarsely crush them for later use; (2) Place the coarse powder of the medicinal material into a steam distillation extraction device, add 10-20 times the amount of water of the medicinal material, soak overnight to allow the medicinal material to fully absorb water and become moist. (3) Heat to boiling, then reduce the heating temperature to 80℃-100℃ and maintain it for 4-8 hours. Collect the condensate to obtain aromatic water. (4) Filter the residue, collect the filtrate, and obtain the extract. In the external application traditional Chinese medicine composition, the amount of aromatic water added is 45-60% by weight, and the amount of extract added is 30-55%.

2. The topical Chinese medicine composition according to claim 1, characterized in that: By weight, the traditional Chinese medicine composition is made from 6 parts of Artemisia argyi, 6 parts of Chrysanthemum morifolium, 6 parts of Clematis armandii, 6 parts of Schizonepeta tenuifolia, 6 parts of Saposhnikovia divaricata, 12 parts of Mentha haplocalyx, 6 parts of Pogostemon cablin, and 6 parts of Nardostachys jatamansi. The preparation method of the traditional Chinese medicine composition includes the following steps: (1) Weigh out the following ingredients according to the proportions: mugwort leaves, chrysanthemum, nine-section tea, schizonepeta, saposhnikovia, mint, patchouli, and nard, and coarsely crush them for later use; (2) Place the coarse powder of the medicinal material into a steam distillation extraction device, add 16 times the amount of water of the medicinal material, and soak overnight to allow the medicinal material to fully absorb water and become moist. (3) Heat to boiling, then reduce the heating temperature to 85°C and maintain for 6 hours. Collect the condensate to obtain aromatic water. (4) Filter the residue, collect the filtrate, and obtain the extract. In the external Chinese medicine composition, the amount of aromatic water added is 45% and the amount of extract added is 55% by weight percentage.

3. The method for preparing the external application traditional Chinese medicine composition according to claim 1, characterized in that: The preparation method includes the following steps: (1) Weigh out the following ingredients according to the proportions: mugwort leaves, chrysanthemum, nine-section tea, schizonepeta, saposhnikovia, mint, patchouli, and nard, and coarsely crush them for later use; (2) Place the coarse powder of the medicinal material into a steam distillation extraction device, add 10-20 times the amount of water of the medicinal material, soak overnight to allow the medicinal material to fully absorb water and become moist. (3) Heat to boiling, then reduce the heating temperature to 80℃-100℃ and maintain it for 4-8 hours. Collect the condensate to obtain aromatic water. (4) Filter the residue, collect the filtrate, and obtain the extract. In the external application traditional Chinese medicine composition, the amount of aromatic water added is 45-60% by weight, and the amount of extract added is 30-55%.

4. The preparation method according to claim 3, characterized in that: The preparation method of the traditional Chinese medicine composition includes the following steps: (1) Weigh out the following ingredients according to the proportions: mugwort leaves, chrysanthemum, nine-section tea, schizonepeta, saposhnikovia, mint, patchouli, and nard, and coarsely crush them for later use; (2) Place the coarse powder of the medicinal material into a steam distillation extraction device, add 16 times the amount of water of the medicinal material, and soak overnight to allow the medicinal material to fully absorb water and become moist. (3) Heat to boiling, then reduce the heating temperature to 85°C and maintain for 6 hours. Collect the condensate to obtain aromatic water. (4) Filter the residue, collect the filtrate, and obtain the extract. In the external Chinese medicine composition, the amount of aromatic water added is 45% and the amount of extract added is 55% by weight percentage.

5. The use of the topical Chinese medicine composition according to claim 1 or claim 2, or the topical Chinese medicine composition prepared by the preparation method according to claim 3 or claim 4, in the preparation of topical products for the prevention and treatment of hair loss.

6. The use according to claim 5, characterized in that: The external products mentioned are medicines or personal care products.

7. The use according to claim 5, characterized in that: The topical product is a gel, ointment, or foam.

8. The use according to claim 5, characterized in that: The topical product is a cream.

9. The use according to claim 5, characterized in that: The topical product is shampoo or conditioner.

10. The use according to claim 5, characterized in that: The hair loss is one or more of the following: androgenetic alopecia, neurogenic alopecia, endocrine alopecia, nutritional alopecia, physical alopecia, chemical alopecia, infectious alopecia, congenital alopecia, or seasonal alopecia.

11. The use according to claim 5, characterized in that: The topical product enhances the activity of hair follicle tissue, prompting resting hair follicles to enter the regeneration cycle and promoting hair growth.

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