A traditional Chinese medicine composition for promoting hair growth and its preparation method and application

Abstract

This invention relates to the field of traditional Chinese medicine (TCM) technology, and particularly to a TCM composition for promoting hair growth and its preparation method and application. The TCM composition is prepared from the following raw materials in parts by weight: 1-8 parts dandelion, 1-8 parts *Polygonum chinense*, 1-8 parts *Gastrodia elata*, 2-10 parts mulberry leaf, 1-8 parts *Achyranthes bidentata*, 1-8 parts *Taxillus chinensis*, 4-12 parts *Platycladus orientalis* leaf, 2-10 parts *Eclipta prostrata*, 1-8 parts *Ligustrum lucidum*, 2-10 parts *Polygonum multiflorum*, 2-6 parts black jujube, 1-8 parts *Lonicera japonica* vine, and 1-8 parts *Angelica dahurica*. The TCM composition is used to prevent or treat hair loss, with rapid and significant effects, high safety, and generally does not cause side effects or adverse reactions, nor does it cause excessive irritation.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a hair-strengthening and hair-growth-promoting traditional Chinese medicine composition, its preparation method, and its application. Background Technology

[0002] Hair loss is a common physiological phenomenon that not only affects appearance but can also lead to skin conditions such as dermatitis and folliculitis. Currently, there are numerous methods to promote hair regrowth. However, each method, based on different principles, typically has its own limitations.

[0003] Minoxidil is a commonly used hair growth agent in clinical practice. Its mechanism of action relies on sulfotransferases present in the outer root sheath of human hair follicles. Under the catalytic conversion of endogenous sulfotransferases, minoxidil can generate active minoxidil sulfate, which is the key substance for achieving its anti-hair loss effect. Specifically, the hair growth mechanism of minoxidil is mainly reflected in the following aspects: First, under the action of sulfotransferases, it is converted into active minoxidil sulfate, which directly exerts its anti-hair loss and hair growth effects; Second, it can promote angiogenesis and capillary dilation, increase blood supply to the hair follicle, thereby stimulating the proliferation of hair follicle epithelial cells, while reducing the damage of androgens to hair follicles, reducing the occurrence of hair thinning, softening, and loss; Third, it can regulate the proportion of trace elements in hair follicle cells, increasing the intracellular potassium ion content and indirectly reducing the calcium ion content. Related studies have shown that calcium ions have an inhibitory effect on hair follicle growth.

[0004] However, the effectiveness of minoxidil is greatly affected by individual differences. Due to variations in the content and activity of sulfotransferase in the outer root sheath of hair follicles among different individuals, those with higher enzyme activity respond significantly better to minoxidil than those with lower activity. This results in some users experiencing faster hair regrowth after using minoxidil, while others experience slow recovery or even no noticeable effect. In other words, the activity of sulfotransferase directly determines the hair regrowth effect of minoxidil. Furthermore, if the hair loss has been prolonged and the hair follicles have atrophied and closed, using minoxidil will also be unlikely to achieve the desired hair regrowth effect.

[0005] In clinical applications, the most common adverse reaction to minoxidil solution is mild scalp dermatitis. Other reports indicate that various other adverse reactions may occur after using this product, but the causal relationship between these adverse reactions and minoxidil use is not yet clear. These include: irritant dermatitis (redness, scaling, and burning), mild erythema, itching, nonspecific allergic reactions, wheals, allergic rhinitis, facial swelling, allergies, shortness of breath, headache, neuritis, dizziness, syncope, vertigo, edema, chest pain, changes in blood pressure, palpitations, and changes in pulse rate.

[0006] Studies have shown that tanshinone, the active ingredient in Danshen (Salvia miltiorrhiza), can promote hair growth in mice and improve dihydrotestosterone (DHT)-induced androgenetic alopecia. DHT may alter the hair growth cycle by inducing autophagy, inhibiting telogen follicles from entering the anagen phase. Tanshinone capsules may improve androgenetic alopecia by inhibiting autophagy, promoting telogen follicles to enter the anagen phase, and prolonging the anagen phase. It should be noted that tanshinone capsules are an oral preparation. Currently, the only oral medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of androgenetic alopecia is finasteride. Finasteride is a synthetic steroid compound that acts as a specific inhibitor of intracellular type II 5α-reductase during the metabolism of androgens (testosterone) to dihydrotestosterone (DHT). It can promote hair growth and prevent the continued progression of hair loss by inhibiting the local production of DHT in the scalp.

[0007] In clinical applications, finasteride typically produces certain side effects, including decreased libido, abnormal ejaculation, testicular pain, and even erectile dysfunction. However, these symptoms generally return to normal within about six months of discontinuing finasteride use and usually do not cause functional damage to the body. Nevertheless, they can still cause psychological distress for users, affecting medication adherence. Furthermore, hair growth drugs with finasteride, tanshinone, and other similar ingredients often work by inhibiting dihydrotestosterone receptor activity, reducing the catalytic effect of androgens in the scalp, thereby promoting hair growth. However, the therapeutic effect of these drugs is limited, requiring long-term consistent use to achieve noticeable results. They may also cause local discomfort such as dry scalp and itching, further restricting their clinical application.

[0008] In addition to the aforementioned drug treatments, there are other non-drug methods for hair regrowth, such as phototherapy. This therapy uses low-energy pulsed lasers and heat-mediated light therapy to stimulate hair growth and enhance hair root health, thereby improving hair loss symptoms. However, this type of phototherapy has significant limitations; it requires long-term, continuous treatment and is relatively expensive, making it difficult to widely apply to the general population experiencing hair loss.

[0009] In addition, there are other transplantation methods such as hair transplantation and skin flap transplantation. Although these methods can directly achieve hair regeneration, with obvious treatment effects and a high success rate, and can quickly improve the appearance of hair loss, the safety of these transplantation methods still needs further research and demonstration. Postoperative complications, long-term prognosis and other related issues have not been fully clarified, which to some extent limits their clinical application.

[0010] In view of this, the present invention is hereby proposed. Summary of the Invention

[0011] To address the limitations of existing hair regrowth methods, this invention provides a traditional Chinese medicine composition with hair regrowth effects, its preparation method, and its application. When used to prevent or treat hair loss, this composition is fast-acting, effective, and highly safe, generally without causing side effects or adverse reactions, and without excessive irritation to the scalp. Furthermore, the traditional Chinese medicine composition provided by this invention can also regulate overall scalp health, effectively alleviating dandruff, moisturizing hair follicles, increasing scalp nutrition, reducing scalp itching, and improving scalp health.

[0012] Specifically, the technical solution provided by this invention is as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for strengthening hair growth, which is prepared from the following raw materials in parts by weight: 1-8 parts of dandelion, 1-8 parts of Polygonum chinense, 1-8 parts of Gastrodia elata, 2-10 parts of mulberry leaf, 1-8 parts of Achyranthes bidentata, 1-8 parts of Taxillus chinensis, 4-12 parts of Platycladus orientalis leaf, 2-10 parts of Eclipta prostrata, 1-8 parts of Ligustrum lucidum, 2-10 parts of Polygonum multiflorum, 2-6 parts of black jujube, 1-8 parts of Lonicera japonica, and 1-8 parts of Angelica dahurica.

[0013] In this invention, the sources, efficacy, and compatibility principles of each raw material in the traditional Chinese medicine composition are as follows: Polygonum multiflorum, belonging to the Polygonaceae family, enters the liver, heart, and kidney meridians; it has the effects of nourishing blood and benefiting the liver, consolidating essence and benefiting the kidneys, and strengthening muscles and bones, and is a traditional tonic. In this invention, processed Polygonum multiflorum is preferred, and its core function is to improve the symptoms of liver and kidney deficiency and qi and blood deficiency, fully exerting its potential to nourish blood and promote hair growth, and providing internal nourishment for hair growth.

[0014] Dandelion, belonging to the Asteraceae family, is cold in nature and bitter and sweet in taste. It enters the liver and stomach meridians and has the effects of clearing heat and detoxifying, reducing swelling and dissipating nodules. In this invention, dandelion is mainly used for symptoms of heat toxicity. Simultaneously, this invention utilizes the high iron and calcium content of dandelion to supplement hair follicles with necessary nutrients, further promoting hair follicle health and hair growth.

[0015] The leaves of Platycladus orientalis, the dried branches and leaves of the Platycladus orientalis plant (Callicarpa spp.), are cold in nature and bitter in taste. They enter the lung, liver, and spleen meridians and have the effects of cooling the blood and stopping bleeding, resolving phlegm and relieving cough. This invention utilizes the pharmacological characteristics of Platycladus orientalis leaves—bitter, cold, and entering the blood—to cool the blood, stop bleeding, and enter the liver meridian. It uses these leaves to cool the blood, dispel wind, promote hair growth, and darken hair. When used in combination with other ingredients in the formula, such as processed Polygonum multiflorum, Ligustrum lucidum, and Eclipta prostrata, it can synergistically improve hair loss-related symptoms caused by liver and kidney deficiency and depletion of essence and blood. Furthermore, this invention fully utilizes the flavonoid active ingredients contained in Platycladus orientalis leaves to further enhance the antibacterial and anti-inflammatory effects of the composition.

[0016] Eclipta prostrata, the dried aerial part of the herbaceous plant Eclipta prostrata, is sweet, sour, and cold in nature, and enters the liver and kidney meridians. This invention utilizes the characteristics of Eclipta prostrata—sweet and sour in nature, transforming into yin and entering the liver and kidney meridians—to nourish the liver and kidneys, replenish essence and blood, synergistically enhancing the hair-darkening and hair-growth effects of the composition, providing internal nourishment and support for healthy hair growth.

[0017] Ligustrum lucidum, belonging to the Oleaceae family, is neutral in nature and has a sweet and bitter taste. It enters the liver and kidney meridians and possesses the effects of nourishing yin and promoting longevity, strengthening the liver and kidneys, and clearing heat and improving eyesight. In this invention, Ligustrum lucidum and Eclipta prostrata are used synergistically to enhance their effects, primarily targeting the symptoms of premature graying and sparse hair caused by liver and kidney yin deficiency, further strengthening the liver-nourishing, kidney-tonifying, and hair-darkening effects of the composition.

[0018] Gastrodia elata, sweet and neutral in nature, enters the liver meridian. It effectively calms internal wind and dispels external wind, while also tonifying the liver and kidneys, and relieving pain by unblocking the meridians. In this invention, the combination of Gastrodia elata and Polygonum multiflorum can synergistically address hair loss caused by kidney deficiency with dampness and wind-evil damaging the blood. For hair loss caused by liver wind disturbance and wind-evil invasion, following the treatment principle of calming liver wind and tonifying the liver and kidneys, the combination of Gastrodia elata and Achyranthes bidentata can calm the liver and subdue yang, nourish yin and reduce fire, improving hair malnutrition caused by excessive liver yang. Furthermore, while Gastrodia elata and Achyranthes bidentata have a strong liver-calming effect but a less pronounced yin-tonifying effect, the herbal composition of this invention is further combined with components such as Ligustrum lucidum and Eclipta prostrata to enhance the overall liver-tonifying, kidney-tonifying, essence-nourishing, and blood-nourishing effects, achieving a balance between "calming the liver" and "tonifying yin," better adapting to the pathological mechanism of hair loss.

[0019] Mulberry leaves, sweet and bitter in taste and cold in nature, enter the lung and liver meridians, and have the effects of dispersing wind-heat, calming the liver and improving eyesight, and blackening and protecting hair. In this invention, mulberry leaves are mainly used to clear heat from the liver meridian and also nourish yin. For treating hair loss caused by wind-heat, they can be used together with dandelion to clear liver wind-heat. The two work synergistically to clear liver heat and disperse wind-heat, improving hair loss caused by wind-heat disturbing the meridians. Achyranthes bidentata, the root of the Achyranthes bidentata plant (family Amaranthaceae), is bitter, sweet, sour, and neutral in nature. It enters the liver and kidney meridians and has the functions of tonifying the liver and kidneys, strengthening tendons and bones, and guiding blood downwards. In this invention, Achyranthes bidentata, when used in combination with other liver and kidney tonifying herbs in the formula, can have an auxiliary effect, enhancing the efficacy for hair loss caused by liver and kidney deficiency. Furthermore, it can guide excessive yang downwards, making it suitable for various symptoms of yin deficiency and yang excess, especially for hair loss caused by excessive yang heat. It can improve the scalp's internal environment and promote healthy hair growth by calming the liver, suppressing yang, and guiding heat downwards.

[0020] The traditional Chinese medicine composition provided by this invention is based on traditional Chinese medicine theory, and combines single herbs that are appropriate for the symptoms, which greatly improves the efficacy and safety.

[0021] Specifically, the compatibility principles of the traditional Chinese medicine composition described in this invention are as follows: see attached diagram for compatibility principles. Figure 1 The head is the convergence point of all Yang energies, and hair, like the branches and leaves of grass and trees, must rely on blood for nourishment to thrive. The kidneys store essence, which manifests in the hair; the liver stores blood, and hair is the surplus of blood. Hair that is not properly nourished will wither and, in severe cases, fall out. Therefore, hair loss is most closely related to the dysfunction of the liver and kidneys. In this formula, the arborvitae leaf enters the liver meridian, cools the blood, dispels wind, and promotes hair growth and darkening, making it the principal herb. Mulberry leaf, Eclipta prostrata, and Polygonum multiflorum are added as assistant herbs, assisting the principal herb and enhancing its efficacy. Mulberry leaves and Eclipta prostrata (Japanese eclipta prostrata) cool the blood and stop bleeding, complementing the blood-cooling effect of Platycladus orientalis leaves. Mulberry leaves excel at dispersing wind-heat, clearing away wind-heat pathogens from the scalp and alleviating hair loss caused by wind-heat disturbing the meridians. Eclipta prostrata nourishes the liver and kidneys, replenishes essence and blood, providing internal nourishment for hair growth. Prepared Polygonum multiflorum (He Shou Wu) is considered a "miracle product for nourishing blood, promoting hair growth, and darkening hair," excelling at nourishing blood, benefiting the liver, and strengthening essence and kidneys. Combined with Eclipta prostrata, it enhances the effects of nourishing the liver and kidneys and strengthening the foundation, fundamentally improving the malnourished state of hair. Eclipta prostrata nourishes the liver and kidneys, thus strengthening the foundation. Combined with Eclipta prostrata, it enhances the effects of nourishing the liver and kidneys and strengthening the foundation, fundamentally improving the malnourished state of hair.

[0022] The adjuvant herbs selected are Gastrodia elata, Taxillus chinensis, Ligustrum lucidum, Eclipta prostrata, and Achyranthes bidentata. These five herbs work synergistically, addressing the issues of "tonifying, clearing, and unblocking," assisting the principal and assistant herbs in harmonizing Qi and blood, and nourishing the liver and kidneys. Gastrodia elata excels at nourishing the liver and calming wind, astringing Yin and nourishing blood. Since the liver stores blood, nourishing the liver also nourishes the blood, improving hair malnourishment caused by liver wind disturbing the upper body and insufficient essence and blood. Taxillus chinensis is specifically effective in tonifying the kidneys and replenishing blood, synergistically enhancing the tonifying effect on the liver and kidneys. Ligustrum lucidum and Eclipta prostrata work together, significantly nourishing Yin and blood, further strengthening the nourishment of the liver and kidneys. Achyranthes bidentata not only guides the excessive Yang downwards, tonifying the liver and kidneys, but also removes blood stasis and unblocks the meridians, ensuring the entire formula is tonifying without stagnation. This aligns with the traditional Chinese medicine theory that "without removing blood stasis, new growth cannot occur; removing blood stasis is the way to generate new growth," clearing obstacles for hair regeneration. These five herbs, combined with Polygonum multiflorum, work together to tonify the liver and kidneys, strengthen tendons and bones, and darken the hair. When the Qi of the liver and kidneys is abundant, the hair will be radiant, black, and lustrous. Furthermore, dandelion, *Polygonum chinense*, and honeysuckle vine are added to clear heat from the liver meridian, while also mitigating the potential for the warming and drying properties of *Achyranthes bidentata*, processed *Polygonum multiflorum*, and *Angelica dahurica* to deplete qi and blood. This avoids further damage to qi and blood caused by the warming and drying properties, ensuring the overall formula is mild. *Angelica dahurica* primarily enters the Yangming meridian, and also dries dampness, dispels wind, and relieves pain, alleviating discomfort such as scalp itching and swelling. Black dates tonify the spleen and stomach and harmonize the other herbs, serving as the guiding herb. The combined herbs work synergistically, strengthening the foundation and nourishing and cooling the blood, as well as tonifying the liver and kidneys. With the hair nourished, there is no risk of hair loss. In summary, the combined herbs in this formula are meticulously formulated with clear primary and secondary components. It emphasizes strengthening the foundation while also clearing heat and dispersing blood stasis, achieving a synergistic effect of nourishing and cooling the blood, tonifying the liver and kidneys, dispelling wind and clearing heat, and promoting blood circulation. This allows the hair to be fully nourished, addressing the root cause of hair loss and achieving the therapeutic goal of promoting hair growth.

[0023] Based on the above analysis of hair growth principles, indications, possible adverse reactions and side effects, the pure Chinese medicine preparation of this invention has the advantages of being safer and non-toxic, and it targets a wider range of hair loss causes and is suitable for a wider range of people with hair loss.

[0024] In this invention, the traditional Chinese medicine composition is preferably prepared from the following raw materials in parts by weight: 1-5 parts of dandelion, 1-6 parts of Polygonum chinense, 1-6 parts of Gastrodia elata, 2-6 parts of mulberry leaf, 3-6 parts of Achyranthes bidentata, 4-8 parts of Taxillus chinensis, 6-10 parts of Platycladus orientalis leaf, 3-6 parts of Eclipta prostrata, 2-6 parts of Ligustrum lucidum, 2-4 parts of Polygonum multiflorum, 3-6 parts of black jujube, 2-8 parts of Lonicera japonica, and 4-8 parts of Angelica dahurica.

[0025] More preferably, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 4 parts dandelion, 6 parts Polygonum chinense, 4 parts Gastrodia elata, 4 parts mulberry leaf, 5 parts Achyranthes bidentata, 6 parts Taxillus chinensis, 8 parts Platycladus orientalis leaf, 4 parts Eclipta prostrata, 4 parts Ligustrum lucidum, 4 parts Polygonum multiflorum, 3 parts black dates, 6 parts Lonicera japonica, and 6 parts Angelica dahurica.

[0026] Secondly, the present invention provides a method for preparing the traditional Chinese medicine composition, wherein the raw materials are mixed in proportion, or further pulverized, or further formulated into a preparation.

[0027] Specifically, in this invention, each raw material is preferably washed, drained, and dried, and then subjected to ultrafine pulverization. The ultrafine pulverization time is preferably 30-90 seconds, more preferably 50-70 seconds, and even more preferably 60 seconds. After ultrafine pulverization, the resulting powder particle size preferably passes through a 100-mesh sieve.

[0028] Thirdly, the present invention provides a traditional Chinese medicine preparation, which is made alone from the traditional Chinese medicine composition, or made from the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0029] Preferably, the traditional Chinese medicine preparation is a freeze-dried powder, tablet, capsule, granule or pill.

[0030] More preferably, the traditional Chinese medicine preparation is a freeze-dried powder.

[0031] Fourthly, the present invention provides a method for preparing the aforementioned traditional Chinese medicine preparation, comprising the following steps: S1. Weigh the following ingredients according to the stated weight proportions: dandelion, *Polygonum chinense*, gastrodia elata, mulberry leaf, achyranthes bidentata, mulberry mistletoe, arborvitae leaf, eclipta prostrata, privet fruit, he shou wu, black dates, and honeysuckle vine. Dry and pulverize them to obtain a mixed powder. S2. Mix the mixed powder described in step S1 with 30-40 parts by weight of tristearate to obtain the oil phase; S3. Mix 50-70 parts by weight of soybean lecithin, 40-50 parts by weight of poloxamer 188 and 4-6 parts by weight of water to obtain an aqueous phase; S4. Mix the oil phase described in step S2 and the aqueous phase described in step S3 to obtain a mixed liquid; S5. Freeze-dry the mixture obtained in step S4 to obtain a freeze-dried powder.

[0032] In this invention, glyceryl tristearate, as a nonionic surfactant, possesses multiple functions such as wetting, emulsification, and foaming. Soy lecithin, as a natural emulsifier, emulsifies and decomposes oils. Poloxamer 188, as a nonionic copolymer surfactant, is used as an emulsifier and drug stabilizer.

[0033] In this invention, the preferred weight parts of tristearate glyceryl ester are 35 parts, the preferred weight parts of soybean lecithin are 60 parts, the preferred weight parts of poloxamer 188 are 45 parts, and the preferred weight parts of water are 5 parts.

[0034] In this invention, the mixing temperature in step S2 is preferably 75~85°C, more preferably 80°C.

[0035] The mixing temperature in step S3 is preferably 90~100℃, more preferably 100℃.

[0036] The mixing in step S4 is preferably subjected to high-pressure homogenization, the high-pressure homogenization time is preferably 4 to 6 minutes, more preferably 5 minutes, and the pressure of the high-pressure homogenization is preferably 45,000 to 55,000 psi, more preferably 50,000 psi.

[0037] The freeze-drying process in step S5 preferably includes two stages. The first stage is pre-freezing, where the pre-freezing temperature is preferably -15 to -5°C, more preferably -10°C, and the pre-freezing time is preferably 4 to 6 hours, more preferably 5 hours. The second stage is cooling-drying, where the cooling-drying temperature is preferably -50 to -40°C, more preferably -45°C, the cooling-drying pressure is preferably 0.8 to 1.2 kPa, more preferably 1 kPa, and the cooling-drying time is preferably 24 to 36 hours, more preferably 32 hours.

[0038] In a more preferred embodiment of the present invention, the preparation method of the traditional Chinese medicine preparation includes the following steps: S1. Weigh the following ingredients according to the stated weight proportions: dandelion, *Polygonum chinense*, gastrodia elata, mulberry leaf, achyranthes bidentata, mulberry mistletoe, arborvitae leaf, eclipta prostrata, privet fruit, he shou wu, black dates, and honeysuckle vine. Wash, drain, and dry them. After ultra-fine pulverization for 60 seconds, pass them through a 100-mesh sieve to obtain a mixed powder.

[0039] S2. Add 35 parts by weight of tristearate to the mixed powder and heat in a water bath at 80°C to obtain the oil phase.

[0040] S3. Weigh 60 parts by weight of soybean lecithin and 45 parts by weight of poloxamer 188, add 5 parts by volume of distilled water, stir to dissolve, and heat in a water bath at 100°C to obtain an aqueous phase.

[0041] S4. Mix the oil phase obtained in S2 and the aqueous phase obtained in S3, and shear at high speed for 1-2 minutes at a speed of 1000 rpm; sonicate for 2 minutes at a power of 1000 W and a frequency of 50 kHz; homogenize under high pressure for 4-6 minutes at a pressure of 50000 psi to obtain a mixed liquid.

[0042] S5. Place the mixture in a rotary evaporator and pre-freeze at -10℃ for 4-6 hours. Then adjust the freeze-drying temperature to -45℃, the pressure to 1 kPa, and the time to 24-36 hours to obtain the freeze-dried powder of traditional Chinese medicine.

[0043] Fifthly, the present invention provides the use of the traditional Chinese medicine composition, or the traditional Chinese medicine preparation, in the preparation of a medicament for the prevention or treatment of hair loss. Beneficial effects

[0044] This invention provides a traditional Chinese medicine composition for promoting hair growth and its preparation method and application. The composition has hair growth and can be used to prevent or treat hair loss.

[0045] The traditional Chinese medicine composition provided by this invention can effectively unclog hair follicles blocked by sebum, increase the density of hair follicles, alleviate seborrheic alopecia, and promote hair regeneration.

[0046] The traditional Chinese medicine composition provided by this invention can not only repair hair follicles, but also nourish them, increase their immunity, and further improve hair quality, making it stronger and shinier.

[0047] The traditional Chinese medicine composition provided by this invention can be applied to the skin surface for drug administration. The active ingredients can quickly penetrate into the epidermis and be absorbed by the skin. It is convenient and quick to use, and the effects are fast after application. It is suitable for people of all ages.

[0048] The traditional Chinese medicine composition described in this invention is a pure traditional Chinese medicine preparation. Through the compounding of multiple raw materials, it has a synergistic effect and is naturally safe with low toxicity and side effects. Compared with traditional chemically synthesized drugs, the traditional Chinese medicine composition and its preparation provided by this invention have significantly reduced skin irritation, are gentle in action, have no allergic reactions, have high transdermal absorption efficiency, and provide long-lasting hair growth and strengthening effects. Therefore, the traditional Chinese medicine composition provided by this invention overcomes the shortcomings of traditional chemically synthesized drugs, such as large side effects, serious drug dependence, and unsatisfactory effects. Attached Figure Description

[0049] To more clearly illustrate the technical solutions in this invention or the prior art, the accompanying drawings used in the description of the embodiments or the prior art will be described below.

[0050] Figure 1 It is the principle of compatibility of traditional Chinese medicine compositions; Figure 2 This is the experimental grouping route diagram described in Experiment Example 1 of this invention.

[0051] Figure 3 This is a before-and-after comparison diagram of the high-dose group medication described in Experiment Example 1 of this invention.

[0052] Figure 4 This is a before-and-after comparison diagram of the medium-dose group medication described in Experimental Example 1 of this invention.

[0053] Figure 5 This is a before-and-after comparison diagram of the low-dose group medication described in Experimental Example 1 of this invention.

[0054] Figure 6 This is a comparison image of the blank control group before and after applying cooled boiled water, as described in Experimental Example 1 of this invention. Figure 7 HE staining of mouse fur at different doses of the patented drug group described in Experimental Example 1 of this invention. Detailed Implementation

[0055] The following examples are used to illustrate the present invention, but are not intended to limit the scope of the invention. Any modifications or substitutions made to the methods, steps, or conditions of the present invention without departing from the spirit and essence of the invention are within the scope of protection of the present invention. Unless otherwise specified, the experimental materials, reagents, instruments, etc., used in the examples of the present invention are all commercially available; unless specifically specified, all technical means in the examples of the present invention are conventional means well known to those skilled in the art. Example 1

[0056] This embodiment provides a traditional Chinese medicine composition for hair growth and development, the formula of which is shown below: Dandelion 4 parts, Polygonum chinense 6 parts, Gastrodia elata 4 parts, Mulberry leaf 4 parts, Achyranthes bidentata 5 parts, Taxillus chinensis 6 parts, Platycladus orientalis leaf 8 parts, Eclipta prostrata 4 parts, Ligustrum lucidum 4 parts, Polygonum multiflorum 4 parts, Black jujube 3 parts, Lonicera japonica 6 parts, Angelica dahurica 6 parts.

[0057] This embodiment also provides a method for preparing the traditional Chinese medicine composition, including the following steps: S1. Weigh the following ingredients according to the stated weight proportions: dandelion, *Polygonum chinense*, gastrodia elata, mulberry leaf, achyranthes bidentata, mulberry mistletoe, arborvitae leaf, eclipta prostrata, privet fruit, he shou wu, black dates, and honeysuckle vine. Wash, drain, and dry them. After ultra-fine pulverization for 60 seconds, pass them through a 100-mesh sieve to obtain a mixed powder.

[0058] S2. Add 35 parts by weight of tristearate to the mixed powder and heat in a water bath at 80°C to obtain the oil phase.

[0059] S3. Weigh 60 parts by weight of soybean lecithin and 45 parts by weight of poloxamer 188, add 5 parts by volume of distilled water, stir to dissolve, and heat in a water bath at 100°C to obtain an aqueous phase.

[0060] S4. Mix the oil phase obtained in S2 and the aqueous phase obtained in S3, and shear at high speed for 1.5 min at a speed of 1000 rpm; sonicate for 2 min at a power of 1000 W and a frequency of 50 kHz; homogenize under high pressure for 5 min at a pressure of 50000 psi to obtain a mixed liquid.

[0061] S5. Place the mixture in a rotary evaporator, pre-freeze at -10℃ for 5 hours, then adjust the freeze-drying temperature to -45℃, the pressure to 1 kPa, and the time to 30 hours to obtain the freeze-dried powder of traditional Chinese medicine. Example 2

[0062] This embodiment provides a traditional Chinese medicine composition for hair growth and development, which differs from Example 1 only in its formulation: Dandelion 2 parts, Polygonum chinense 6 parts, Gastrodia elata 4 parts, mulberry leaf 3 parts, Achyranthes bidentata 3 parts, Taxillus chinensis 8 parts, Platycladus orientalis leaf 6 parts, Eclipta prostrata 5 parts, Ligustrum lucidum 2 parts, Polygonum multiflorum 4 parts, black jujube 4 parts, Lonicera japonica 6 parts, Angelica dahurica 4 parts. Example 3

[0063] This embodiment provides a traditional Chinese medicine composition for hair growth and development, which differs from Example 1 only in its formulation: Dandelion 2 parts, Polygonum chinense 2 parts, Gastrodia elata 4 parts, Mulberry leaf 6 parts, Achyranthes bidentata 6 parts, Taxillus chinensis 8 parts, Platycladus orientalis leaf 6 parts, Eclipta prostrata 4 parts, Ligustrum lucidum 5 parts, Polygonum multiflorum 2 parts, Jujube 6 parts, Lonicera japonica 3 parts, Angelica dahurica 5 parts. Experimental Example 1

[0064] This experiment uses the traditional Chinese medicine composition provided in Example 1 as the experimental drug, commercially available hair growth liquid as the positive control, and cooled boiled water as the blank control to conduct an efficacy experiment on hair growth. The specific experimental procedures are as follows.

[0065] (1) Grouping of mice and treatment with drugs.

[0066] C57BL / 6J mice, purchased from Guangdong Zhiyuan Biomedical Technology Co., Ltd., were used as experimental animals. First, Veet hair removal cream (from France, manufactured by Reckitt Benckiser (China) Co., Ltd.) was used to shave the hair on the backs of each mouse, exposing the pinkish skin. Then, the mice were divided into 5 groups (blank control group, positive control group, high-dose group, medium-dose group, and low-dose group), with 6 mice in each group. The experimental grouping route is as follows: Figure 1 As shown.

[0067] Treatment: The mice in all five groups were smeared twice a day (at 12 noon and 6 pm). The high-dose group was smeared with an equal amount of the original drug solution, the medium-dose group was smeared with an equal amount of the original drug solution diluted 1 time, the low-dose group was smeared with an equal amount of the original drug solution diluted 2 times, the positive control group was smeared with an equal amount of commercially available hair growth solution, and the blank control group was smeared with an equal amount of cooled boiled water.

[0068] (2) Sampling and specimen processing.

[0069] After the last administration, all mice were fasted for 12 hours and then administered an intraperitoneal injection of 0.2 mL of 4% chloral hydrate solution (under general anesthesia). Samples were then collected as follows: ① Using ophthalmic scissors, a 1.5cm*1.5cm piece of skin tissue was taken from the hairless area on the back of the mouse and placed in an EP tube. The tissue was fixed in a 10% formaldehyde solution. The removed tissue was dehydrated, embedded in paraffin, sectioned, and stained with hematoxylin and eosin (HE). The number of vellus hairs and terminal hairs was counted under an optical microscope, and the morphology of the hair follicles was observed. Another piece of skin was taken and stored in an EP tube at -80℃ for later use.

[0070] ② Blood was collected by enucleation method. Approximately 1 mL of blood was collected from each mouse and placed in a sterile EP tube. The tube was left at room temperature for 20 minutes until the blood coagulated naturally. Then, the tube was centrifuged at 4000 rpm for 10 minutes. The supernatant was collected and stored in a sterile EP tube at -80℃ for later use.

[0071] (3) Observation indicators.

[0072] ① Observation of the general condition of experimental animals: changes in the color of the skin on the back of the experimental animals, abnormal conditions of the skin at the administration site during the administration process (redness, swelling, blisters, ulceration, erosion and other contact dermatitis-like symptoms), and changes in the living habits and eating habits of mice.

[0073] ② Skin tissue pathological examination: Observe the changes in hair follicle morphology in each pathological section, and select the field of view with the most hair follicles. Count the total number of hair follicles, the number of terminal hair follicles, and the number of vellus hair follicles under 100x magnification to calculate the terminal hair / vellus hair ratio.

[0074] ③ Determination of testosterone, dihydrotestosterone (DHT), and type II 5α-reductase levels in serum and skin tissue: Serum and skin tissue samples stored at -80℃ were removed and refrigerated at 4℃. After complete thawing, the OD450 values ​​of testosterone, DHT, and type II 5α-reductase in serum and skin tissue homogenate samples were measured according to the enzyme-linked immunosorbent assay (ELISA) kit instructions. Based on the obtained standard concentrations and corresponding OD450 values, the results were analyzed using Curve Expert software to generate a standard curve, thereby further calculating the concentrations of testosterone, DHT, and type II 5α-reductase. (4) Toxicity test.

[0075] ① Anatomical examination of the heart, liver, spleen, lungs and kidneys: First, observe the color, shape and size of each organ with the naked eye, then fix them with formalin solution, embed them in paraffin, stain them with HE and observe them under a microscope (comparison between the normal group and the drug-treated group).

[0076] ② Urine test: Collect at least 1 mL of fresh urine for the 10 urine tests, and complete the test within 2 hours.

[0077] Experimental results are as follows Figures 3-6 As shown.

[0078] The experimental results showed that: after administration of the high-dose group, the growth rate was fast, the skin color changed greatly, and the hair growth phenomenon was obvious; after administration of the medium-dose group, the growth rate was relatively fast, the skin color changed significantly, and the hair growth phenomenon was relatively obvious; after administration of the low-dose group, the growth rate was slow, the skin color changed, and the hair growth phenomenon was present, but it was less obvious compared to the high-dose and medium-dose groups; no hair growth phenomenon was observed after applying cold boiled water to the blank control group.

[0079] Experimental results are as follows Figure 7 As shown.

[0080] Experimental results show that: The blank control group showed the slowest or weakest hair regrowth compared to the minoxidil group and the patented drug group; it also had the fewest hair follicles and the lowest density. Results from the low, medium, and high dose groups showed that most hair follicles were in the resting phase, with short structures and a low proportion of follicles in the growth phase. The dermis was thinner, and the number of blood vessels was relatively fewer.

[0081] Minoxidil group: Compared with the minoxidil group and the patented drug group, hair regeneration was more significant; the number, density, and depth of hair follicles were significantly better than the control group. Observations from the low, medium, and high dose groups showed a significantly increased proportion of hair follicles in the growth phase, and more active cell proliferation in the hair bulb; the dermis may have a richer blood supply, providing more nutrients to the hair follicles.

[0082] Patented drug group: Compared with the control group, the patented drug group showed significantly better results in terms of hair follicle number, structure, and anagen phase ratio per unit field, indicating that the drug has the potential to promote hair growth. Compared with the minoxidil group, the patented drug group showed significantly better results in terms of hair follicle integrity, density, and depth, indicating that the patented drug group is more effective in promoting hair follicles to enter the anagen phase. In addition, there was less inflammatory cell infiltration, showing stronger anti-inflammatory effects; increased dermal thickness; and more microvessels, indicating that the patented drug group has unique advantages such as promoting angiogenesis.

[0083] Results observation of low, medium and high doses of the patented drug group: After administration of the low-dose group, the number of hair follicles increased to a certain extent, the skin color changed, and hair regrowth was observed, but the hair regrowth was less obvious compared to the high-dose and medium-dose groups. After administration of the medium dose, the number of hair follicles in the growth phase increased, the density was higher, the arrangement was deeper, the skin color changed more significantly, the hair follicle structure was more intact, the cells in the hair bulb were more active near the basement membrane, there was less inflammatory cell infiltration, showing a strong anti-inflammatory effect, the dermis thickness increased, more microvessels appeared, and the hair growth phenomenon was more obvious.

[0084] After administration of the high-dose group, the number of hair follicles in the growth phase increased significantly, the density increased, the arrangement was deeper, the skin color changed more significantly, the hair follicle structure was more complete, the cells in the hair bulb proliferated actively, the infiltration of inflammatory cells was less, showing a stronger anti-inflammatory effect, the dermis thickness increased, more microvessels appeared, and the hair growth phenomenon was significant. Figure 1 It is the principle of compatibility of traditional Chinese medicine compositions; Figure 2 It is an experimental route map; Figure 3 The before-and-after comparison of high-dose medication shows that the high-dose group has a faster growth rate, greater changes in cortical color, and obvious hair growth after administration. Figure 4 The before-and-after comparison chart of the medium-dose group shows that the growth rate of the medium-dose group is faster, the color of the cortex changes more significantly, and the hair growth phenomenon is more obvious after the medium-dose group is administered; Figure 5 The comparison chart before and after medication in the low-dose group shows that the growth rate in the low-dose group is slower, the color of the cortex changes, and there is hair growth, but the hair growth is less obvious compared to the high-dose and medium-dose groups. Figure 6 The comparison chart before and after applying cold boiled water to the blank control group shows that no hair growth occurred after applying cold boiled water to the blank control group. Figure 7 HE staining of mouse hair at different doses showed that, based on indicators such as the number, structure, density, depth, and proportion of hair follicles in the growth phase, the hair regeneration effect was: blank control group < minoxidil group < patented drug group.

[0085] Although the present invention has been described in detail above with general descriptions and specific embodiments, modifications or improvements can be made to it, which will be obvious to those skilled in the art. Therefore, all such modifications or improvements made without departing from the spirit of the present invention fall within the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, It is prepared from the following raw materials in parts by weight: 1-8 parts dandelion, 1-8 parts Polygonum chinense, 1-8 parts Gastrodia elata, 2-10 parts mulberry leaf, 1-8 parts Achyranthes bidentata, 1-8 parts Taxillus chinensis, 4-12 parts Platycladus orientalis leaf, 2-10 parts Eclipta prostrata, 1-8 parts Ligustrum lucidum, 2-10 parts Polygonum multiflorum, 2-6 parts black dates, 1-8 parts Lonicera japonica, and 1-8 parts Angelica dahurica.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is prepared from the following raw materials in parts by weight: 1-5 parts dandelion, 1-6 parts Polygonum chinense, 1-6 parts Gastrodia elata, 2-6 parts mulberry leaf, 3-6 parts Achyranthes bidentata, 4-8 parts Taxillus chinensis, 6-10 parts Platycladus orientalis leaf, 3-6 parts Eclipta prostrata, 2-6 parts Ligustrum lucidum, 2-4 parts Polygonum multiflorum, 3-6 parts black dates, 2-8 parts Lonicera japonica, and 4-8 parts Angelica dahurica.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 4 parts dandelion, 6 parts Polygonum chinense, 4 parts Gastrodia elata, 4 parts mulberry leaf, 5 parts Achyranthes bidentata, 6 parts Taxillus chinensis, 8 parts Platycladus orientalis leaf, 4 parts Eclipta prostrata, 4 parts Ligustrum lucidum, 4 parts Polygonum multiflorum, 3 parts black dates, 6 parts Lonicera japonica, and 6 parts Angelica dahurica.

4. A method for preparing the traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that, The raw materials are mixed according to the formula, or further pulverized, or further formulated into preparations.

5. A traditional Chinese medicine preparation, characterized in that, It is prepared by the traditional Chinese medicine composition according to any one of claims 1 to 3 alone, or by the traditional Chinese medicine composition according to any one of claims 1 to 3 with pharmaceutically acceptable excipients.

6. The traditional Chinese medicine preparation according to claim 5, characterized in that, The traditional Chinese medicine preparations are freeze-dried powders, tablets, capsules, granules, or pills.

7. The traditional Chinese medicine preparation according to claim 6, characterized in that, The traditional Chinese medicine preparation is a freeze-dried powder.

8. The method for preparing the traditional Chinese medicine preparation according to claim 6 or 7, characterized in that, Includes the following steps: S1. Weigh the following ingredients according to the stated weight proportions: dandelion, *Polygonum chinense*, gastrodia elata, mulberry leaf, achyranthes bidentata, mulberry mistletoe, arborvitae leaf, eclipta prostrata, privet fruit, he shou wu, black dates, and honeysuckle vine. Dry and pulverize them to obtain a mixed powder. S2. Mix the mixed powder described in step S1 with 30-40 parts by weight of tristearate to obtain the oil phase; S3. Mix 50-70 parts by weight of soybean lecithin, 40-50 parts by weight of poloxamer 188 and 4-6 parts by weight of water to obtain an aqueous phase; S4. Mix the oil phase described in step S2 and the aqueous phase described in step S3 to obtain a mixed liquid; S5. Freeze-dry the mixture obtained in step S4 to obtain a freeze-dried powder.

9. The method for preparing the traditional Chinese medicine preparation according to claim 8, characterized in that, The mixing temperature in step S2 is 75~85℃; And / or, the mixing temperature in step S3 is 90~100℃; And / or, the mixture in step S4 is subjected to high-pressure homogenization, the high-pressure homogenization time is 4~6 min, and the pressure is 45000~55000 psi; And / or, the freeze-drying in step S5 includes two stages: the first stage is pre-freezing, the pre-freezing temperature is -15~-5℃, and the pre-freezing time is 4~6h; the second stage is cooling drying, the cooling drying temperature is -50~-40℃, the cooling drying pressure is 0.8~1.2kPa, and the cooling drying time is 24~36h.

10. The use of the traditional Chinese medicine composition according to any one of claims 1 to 3, or the traditional Chinese medicine preparation according to any one of claims 5 to 7, in the preparation of a medicament for the prevention or treatment of hair loss.

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