A hair-growing traditional Chinese medicine composition, a preparation method thereof and application thereof

Abstract

The application discloses a hair-growing traditional Chinese medicine composition and a preparation method and application thereof, and relates to the technical field of traditional Chinese medicine compositions. The raw medicine of the composition is composed of twelve kinds of medicine materials, i.e., raw Chinese arborvitae leaves, rhizoma drynariae, salvia miltiorrhiza, angelica sinensis, chuanxiong rhizome, safflower, warm and smooth medicine materials, wind dispelling and antioxidant medicine materials, mulberry medicine materials, viburnum or monkshood, kudzu root or asarum and ligusticum. The composition is prepared into tincture by impregnating extraction with an ethanol solvent, and can also be prepared into spray, gel or film coating agent. In vitro experiment verification shows that the composition has dose-dependent inhibitory effect on the activity of human 5alpha-reductase type II, can reduce the generation of dihydrotestosterone, promotes the proliferation of human hair papilla cells and has the ability of scavenging free radicals. Animal experiments and clinical observation further prove that the composition can promote hair growth, increase hair density and diameter. The composition can be used for preparing medicines for treating alopecia diseases or hair-washing and hair-care products for preventing hair loss and promoting hair growth.

Description

Technical Field

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

[0002] Hair loss is a common hair disease in dermatology clinics, with androgenetic alopecia (AGA) having the highest incidence. Modern medical research has clearly established that the core pathological process of AGA lies in the conversion of testosterone in the scalp to highly active dihydrotestosterone (DHT) under the action of 5α-reductase type II. After DHT binds to androgen receptors in the dermal papilla cells of hair follicles, it triggers a series of signaling pathway changes, ultimately leading to a shortened hair follicle growth phase, hair follicle miniaturization, and an increased proportion of resting follicles. At the same time, local microcirculatory disturbances in the scalp, micro-inflammation around hair follicles, and oxidative stress damage also participate in the occurrence and progression of hair loss.

[0003] Chemical drugs have limited effects due to their single target. For example, minoxidil mainly works through the potassium channel opening mechanism, which makes it difficult to simultaneously cover the multiple pathological links involved in hair loss, such as excessive 5α-reductase activity, insufficient hair follicle cell proliferation, local microcirculation disorders, and oxidative stress damage.

[0004] The use of external Chinese medicine to treat hair loss has a long history. Ge Hong's *Elbow-Side Emergency Prescriptions* from the Jin Dynasty records the use of arborvitae leaves for external hair growth. Later medical texts also contain numerous accounts of using herbal soaks in alcohol for external application to treat baldness. These external preparations often use ethanol as a solvent, extracting the fat-soluble and alcohol-soluble components of the herbs through a soaking method. After being applied to the scalp, they are absorbed through the skin, aiming to improve local blood circulation, reduce scalp sebum, and thus promote hair growth.

[0005] For example, patent CN200610138323 describes a hair growth agent whose formula includes nearly twenty medicinal herbs such as arborvitae leaves, eclipta prostrata, mulberry fruit, privet fruit, fleeceflower root, psoralea corylifolia, achyranthes bidentata, peony bark, red peony root, madder root, rhubarb, vaccaria segetalis, acorus tatarinowii, notoginseng, luffa cylindrica, rehmannia glutinosa, and angelica sinensis. The large number of herbs results in high raw material costs and increased quality control points during production. Patent CN200810142418 discloses an internal and external formula for treating gray hair and hair loss, containing ginseng, privet fruit, arborvitae leaves, eclipta prostrata, fleeceflower root, rehmannia glutinosa, mulberry fruit, Sichuan pepper, old ginger, and vitex trifolia. This formula combines internal and external application rather than a simple external tincture, making its usage relatively complex.

[0006] Some folk remedies contain ingredients that directly contain toxic herbs. For example, Yu Qihai hair growth tincture contains blister beetle, red ladybug, psoralea corylifolia, and Sichuan pepper. Among them, blister beetle and red ladybug are toxic insect-based medicinal materials. Even if used externally, they may cause contact dermatitis, local burns, or even systemic toxic reactions after skin absorption. Therefore, they are not suitable for long-term continuous use. Summary of the Invention

[0007] The technical problem to be solved by this invention is that existing Chinese herbal hair growth preparations have complex formulas and high costs.

[0008] To address the above problems, the present invention proposes the following technical solution:

[0009] In a first aspect, the present invention provides a traditional Chinese medicine composition for hair growth, wherein the raw materials comprise the following medicinal materials in parts by weight:

[0010] 35-45 parts of fresh Platycladus orientalis leaves

[0011] 25-35 parts of Drynaria fortunei

[0012] 20-28 parts of Salvia miltiorrhiza

[0013] Angelica sinensis 18-22 parts

[0014] Chuanxiong 10-14 parts

[0015] 6-10 parts safflower

[0016] 10-28 portions of warming and invigorating medicinal herbs

[0017] 8-22 parts of wind-dispelling and antioxidant medicinal herbs

[0018] 10-18 parts of mulberry-derived medicinal materials, 10-14 parts of Vitex trifolia fruit, or 6-10 parts of Cimicifuga rhizome.

[0019] 8-12 parts of kudzu root or 3-7 parts of asarum root

[0020] 6-10 parts of Ligusticum striatum

[0021] The warming and invigorating medicinal material is selected from any one of fresh ginger, dried ginger, or galangal.

[0022] The wind-dispelling and antioxidant medicinal materials are selected from any one of pine needles, cypress seeds, or ginkgo leaves.

[0023] Furthermore, the amount of fresh ginger used is 18-28 parts, the amount of dried ginger used is 18-22 parts, or the amount of galangal used is 10-14 parts.

[0024] Furthermore, the amount of pine needles used is 18-22 parts, the amount of cypress seed kernels is 13-17 parts, or the amount of ginkgo leaves is 8-12 parts.

[0025] Furthermore, the medicinal material of the mulberry family is mulberry leaf or mulberry bark, wherein the amount of mulberry leaf is 12-18 parts and the amount of mulberry bark is 10-14 parts.

[0026] Furthermore, the dosage form of the hair growth herbal composition is a tincture, spray, gel, or film-forming agent.

[0027] Secondly, the present invention provides a method for preparing the hair growth herbal composition, comprising the following steps:

[0028] (1) After cleaning each raw material, crush or cut it to obtain pretreated medicinal materials;

[0029] (2) Extract the pretreated medicinal materials obtained in step (1) with an ethanol solvent. The ethanol solvent is an aqueous solution of ethanol with a volume fraction of 55%-80%, and the amount used is such that the ratio of solvent volume to total weight of medicinal materials is 2:1 to 4:1.

[0030] (3) After extraction, separate the residue from the extract and collect the extract to obtain the final product.

[0031] Furthermore, step (1) also includes: before pulverizing or cutting after cleaning, take fresh arborvitae leaves, wind-dispelling and antioxidant medicinal materials and chuanxiong, extract them with supercritical CO2, collect the extract, combine the extracted residue with the remaining raw materials, and then carry out subsequent pulverizing or cutting treatment to obtain pretreated medicinal materials.

[0032] Step (3) also includes: combining the extract with the obtained extract solution to obtain the final product.

[0033] Furthermore, the crushing or cutting process includes cleaning and cutting the arborvitae leaves, wind-dispelling and antioxidant herbs, and mulberry leaves into 1.0-2.0cm segments, washing and cutting the warming herbs into 2.0-3.0mm thin slices, and crushing the remaining herbs, with the coarse powder passing through a 10-20 mesh sieve.

[0034] Further, the extraction in step (2) is as follows: the pretreated medicinal material is mixed with an ethanol-containing solvent, sealed, and left to stand and soak for 14-28 days at 15-25°C in the dark, with intermittent shaking during the soaking period.

[0035] Furthermore, step (2) also includes ultrasonic treatment of the mixture of medicinal materials and ethanol solvent before static soaking, with ultrasonic conditions of 20-50 kHz and 20-60 minutes.

[0036] Further, the solid-liquid separation in step (3) includes: filtering with degreased gauze, rinsing the residue with fresh ethanol solvent and pressing, combining all the filtrates, and taking the supernatant after standing for 12-48 hours.

[0037] Thirdly, the present invention also provides another method for preparing the hair growth herbal composition, comprising the following steps:

[0038] (1) Boil all the medicinal materials in water twice, each time for 0.5-2 hours, and combine the decoctions;

[0039] (2) The decoction obtained in step (1) is concentrated to a relative density of 1.10-1.15 at 60℃;

[0040] (3) Add 95% ethanol to the concentrate to make the alcohol content reach 55%-65%, let it stand for 24 hours, and take the supernatant.

[0041] (4) After recovering the ethanol from the supernatant obtained in step (3), dilute it with an ethanol aqueous solution with an ethanol volume fraction of 55%-80% until the ratio of solvent volume to total weight of medicinal materials is 2:1 to 4:1.

[0042] Fourthly, the present invention also provides the use of the hair growth herbal composition in the preparation of a medicine for treating hair loss diseases or a shampoo and conditioner for preventing hair loss and promoting hair growth.

[0043] Furthermore, the hair loss disease is androgenetic alopecia, alopecia areata, telogen effluvium, postpartum alopecia, or stress-related alopecia.

[0044] Furthermore, the hair care products include shampoo, conditioner, scalp serum, etc.

[0045] Fifthly, the present invention provides a topical hair growth kit, comprising:

[0046] (a) The hair growth herbal composition described above;

[0047] (b) A skin needle for pretreating the scalp before applying the herbal composition.

[0048] Furthermore, the skin needle is a plum blossom needle, a microneedle roller, or an electric skin needle.

[0049] Compared with the prior art, the technical effects achieved by the present invention include:

[0050] The hair growth herbal composition provided by this invention uses fresh Platycladus orientalis leaves as the principal ingredient, combined with Drynaria fortunei, Salvia miltiorrhiza, and other blood-activating and kidney-tonifying herbs, supplemented with Angelica sinensis, Ligusticum chuanxiong, and Carthamus tinctorius to activate and nourish blood. Warming herbs are added to unblock the meridians, wind-dispelling and antioxidant herbs to dispel wind and calm the mind, and Morus alba herbs to disperse wind-heat. Simultaneously, Vitex trifolia or Cimicifuga foetida, Pueraria lobata or Asarum heterotropoides, and Ligusticum striatum are added as guiding herbs to form a meridian-guiding system covering the head, face, forehead, and vertex. When these twelve herbs are combined in specific dosages, they produce a synergistic effect in inhibiting 5α-reductase activity and reducing dihydrotestosterone production. At the same time, they simultaneously intervene in the pathological process of hair loss by promoting dermal papilla cell proliferation, improving local microcirculation in the scalp, and clearing oxidative stress products. The combination of each group of drugs takes into account three levels: etiological blockade, symptom improvement, and targeted delivery, rather than a single-point point-to-point effect. Therefore, the composition as a whole possesses the technical effect of multi-target systemic intervention for hair loss, and has good application prospects.

[0051] The preparation method provided by this invention involves purifying and pulverizing or cutting the raw materials, extracting them with an ethanol-containing solvent of a specific concentration and amount, and collecting the extract after solid-liquid separation. This process targets the tissue structure and polar characteristics of various medicinal materials in the composition, achieving simultaneous and efficient dissolution of multiple active ingredients such as flavonoids, phenolic acids, volatile oils, and gingerols by controlling the solvent concentration and dosage ratio. The extraction method, combining room-temperature, light-protected immersion with intermittent shaking, ensures extraction efficiency while avoiding degradation of heat-sensitive components. The process conditions are mild and controllable, the operation steps are simple and repeatable, and it is suitable for large-scale production.

[0052] The application of the hair growth traditional Chinese medicine composition provided by this invention in the preparation of drugs for treating hair loss or shampoos and conditioners for preventing hair loss and promoting hair growth utilizes the pharmacological basis of the composition's multi-target synergistic intervention in the pathological process of hair loss. It can act on the scalp hair follicle microenvironment in a non-single mechanism, taking into account blocking the source of the disease, improving local circulation and promoting the recovery of hair follicle function. It has application prospects in both pharmaceutical and daily chemical products. Detailed Implementation

[0053] The technical solutions in the embodiments are described clearly and completely below. Obviously, the embodiments described below are only some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0054] It should be understood that, when used in this specification and the appended claims, the terms "comprising" and "including" indicate the presence of the described features, integrals, steps, operations, elements and / or components, but do not exclude the presence or addition of one or more other features, integrals, steps, operations, elements, components and / or collections thereof.

[0055] It should also be understood that the terminology used in the specification of embodiments of the present invention is for the purpose of describing particular embodiments only and is not intended to limit the embodiments of the present invention. As used in the specification of embodiments of the present invention and the appended claims, unless the context clearly indicates otherwise, the singular forms "a," "an," and "the" are intended to include the plural forms.

[0056] This invention provides a traditional Chinese medicine composition for hair growth, the raw materials of which include the following medicinal materials in parts by weight:

[0057] The formula consists of 35-45 parts of fresh Platycladus orientalis leaves, 25-35 parts of Drynaria fortunei, 20-28 parts of Salvia miltiorrhiza, 18-22 parts of Angelica sinensis, 10-14 parts of Ligusticum chuanxiong, 6-10 parts of Carthamus tinctorius, 10-28 parts of warming and invigorating herbs, 8-22 parts of wind-dispelling and antioxidant herbs, 10-18 parts of Morus alba herbs, 10-14 parts of Vitex trifolia fruit or 6-10 parts of Cimicifuga foetida, 8-12 parts of Pueraria lobata or 3-7 parts of Asarum heterotropoides, and 6-10 parts of Ligusticum striatum. The above-mentioned hair-growth-promoting herbal composition is designed around the principles of cooling the blood and promoting blood circulation, dispelling wind and promoting hair growth, and guiding the herbs upwards along the meridians. The entire formula uses fresh arborvitae leaves as the chief ingredient, with Drynaria fortunei and Salvia miltiorrhiza as assistant ingredients. Angelica sinensis, Ligusticum chuanxiong, Carthamus tinctorius, warming and invigorating herbs, wind-dispelling and antioxidant herbs, and Morus alba herbs are used as adjuvant ingredients. Vitex trifolia or Cimicifuga foetida, Pueraria lobata or Asarum heterotropoides, and Ligusticum striatum are used as guiding ingredients. These twelve herbs are combined in specific dosages, each with its own function while also synergistically complementing each other. The following provides a detailed explanation of the role, efficacy, and possible alternatives of each herb in the formula.

[0058] Raw arborvitae leaves are the principal ingredient in this formula, used in doses of 35-45 parts, such as 35, 38, 40, 42, or 45 parts. The raw arborvitae leaves refer to the dried branches and leaves of the arborvitae plant (Platycladus orientalis), used raw, not charred, and should comply with the requirements for arborvitae leaves in Part I of the 2020 edition of the Chinese Pharmacopoeia. Raw arborvitae leaves are bitter and astringent, cold in nature, and enter the lung, liver, and spleen meridians. They have the effects of cooling the blood and stopping bleeding, and promoting hair growth and darkening hair. This formula uses raw arborvitae leaves instead of charred arborvitae leaves because the raw product retains abundant flavonoids, especially quercetin and kaempferol, which can inhibit 5α-reductase type II activity and reduce the conversion of testosterone to dihydrotestosterone, thereby blocking the initiation of hair follicle miniaturization at its source.

[0059] Both Drynaria fortunei and Salvia miltiorrhiza are used as assistant herbs. The dosage of Drynaria fortunei is 25-35 parts, such as 25, 28, 30, 32, or 35 parts, conforming to the regulations under the Drynaria fortunei entry in Part I of the 2020 edition of the Chinese Pharmacopoeia. It is bitter and warm in nature, entering the liver and kidney meridians. Its function is to invigorate blood circulation and promote tendon healing. Its extract can promote the proliferation of human dermal papilla cells and upregulate the expression of vascular endothelial growth factor, helping to prolong the hair follicle growth phase and delay cell degeneration. The dosage of Salvia miltiorrhiza is 20-28 parts, such as 20, 23, 25, 27, or 28 parts, conforming to the regulations under the Salvia miltiorrhiza entry in Part I of the 2020 edition of the Chinese Pharmacopoeia. It is bitter and slightly cold in nature, entering the heart and liver meridians. Its function is to invigorate blood circulation and remove blood stasis. Its tanshinone components can dilate microvessels, reduce blood viscosity, improve local microcirculation in the scalp, and increase blood perfusion and oxygen supply to hair follicles. Drynaria fortunei focuses on promoting the proliferation and growth of hair follicle cells, while Salvia miltiorrhiza focuses on improving the microcirculation and nutrient supply of hair follicles. The two drugs work synergistically, one promoting growth and the other clearing blockages, together building a dual support for promoting hair follicle growth and improving the nutrient supply of hair follicles.

[0060] Angelica sinensis, Ligusticum chuanxiong, and Carthamus tinctorius are used as adjuvant herbs in this formula to promote blood circulation, remove blood stasis, and improve local circulation. The dosage of Angelica sinensis is 18-22 parts, such as 18, 19, 20, 21, or 22 parts, which should comply with the provisions of the Angelica sinensis entry in Part I of the 2020 edition of the Chinese Pharmacopoeia. It is sweet and pungent in taste and warm in nature, and enters the liver, heart, and spleen meridians. It has the effect of promoting blood circulation and removing blood stasis. The ferulic acid it contains can improve local microcirculation of the scalp and promote blood supply around hair follicles after being absorbed through the skin. The dosage of Chuanxiong (Ligusticum striatum) is 10-14 parts, such as 10, 11, 12, 13, or 14 parts, which should comply with the provisions of the Chuanxiong entry in Part I of the 2020 edition of the Chinese Pharmacopoeia. It is pungent and warm in nature, and enters the liver, gallbladder, and pericardium meridians. Its functions are to invigorate blood circulation, promote qi flow, dispel wind, and unblock collaterals. The ligustrazine it contains can dilate blood vessels and improve microcirculation. Furthermore, Chuanxiong has an ascending and dispersing nature, naturally guiding the medicine upwards, which can assist the overall medicinal power of the formula in reaching the head. The dosage of Honghua (Carthamus tinctorius) is 6-10 parts, such as 6, 7, 8, 9, or 10 parts, which should comply with the provisions of the Honghua entry in Part I of the 2020 edition of the Chinese Pharmacopoeia. It is pungent and warm in nature, and enters the heart and liver meridians. Its functions are to invigorate blood circulation, promote menstruation, disperse blood stasis, and unblock collaterals. The safflower yellow pigment it contains has the effect of inhibiting platelet aggregation and improving local blood flow. The three medications work synergistically to improve scalp microcirculation, providing hair follicles with sufficient nutrients and oxygen, while also helping to clear the accumulation of metabolic products caused by local microcirculation disorders.

[0061] The warming and dispersing herbs in this formula function to warm and unblock the meridians and promote circulation. They are selected from fresh ginger, dried ginger, or galangal. Fresh ginger is the preferred choice, with a dosage of 22-28 parts, such as 22, 24, 25, 27, or 28 parts. Fresh ginger is rich in active ingredients unique to fresh ginger, such as 6-gingerol and zingerone, which have strong local warming, dispersing, antibacterial, and anti-inflammatory effects. It can stimulate local blood circulation in the scalp, inhibit the excessive proliferation of pathogenic bacteria on the scalp such as Malassezia, and improve the scalp microenvironment. Dried ginger is the dried product of fresh ginger and should comply with the provisions of the Dried Ginger section of Part I of the 2020 edition of the Chinese Pharmacopoeia. The preferred dosage is 18-22 parts, such as 18, 19, 20, 21, or 22 parts. Its gingerol content is lower than that of fresh ginger, and its warming and dispersing effect is slightly milder. Galangal is the dried rhizome of the ginger family plant *Alpinia galanga*. Its dosage should conform to the *Alpinia galanga* entry in the 2020 edition of the Chinese Pharmacopoeia, with a range of 10-14 parts, such as 10, 11, 12, 13, or 14 parts. It has a strong pungent and warm nature, and its ability to warm the middle jiao, dispel cold, and relieve pain is particularly prominent. The above three warming and unblocking herbs can be selected according to clinical needs and availability, and all can play a fundamental role in warming and unblocking the meridians in the formula.

[0062] The wind-dispelling and antioxidant herbs in this formula play a role in dispelling wind, clearing the meridians, and resisting oxidation. They are selected from pine needles, cypress seeds, or ginkgo leaves. Pine needles, the needles of the Pinus massoniana or Pinus tabuliformis, are a preferred herb in the basic formula. Rich in proanthocyanidins, flavonoids, and volatile oils, they possess significant antioxidant and free radical scavenging capabilities, reducing oxidative stress damage around hair follicles. Their volatile components also help dilate local blood vessels and improve scalp microcirculation. The dosage is 18-22 parts, for example, 18, 19, 20, 21, or 22 parts. Cypress seeds, the dried mature seeds of the Platycladus orientalis, should meet the requirements of the Cypress Seed section in the 2020 edition of the Chinese Pharmacopoeia. Rich in fatty oils and saponins, they have moisturizing, protective, and antioxidant effects. When used as a substitute for pine needles, the dosage is 13-17 parts, for example, 13, 14, 15, 16, or 17 parts. Ginkgo leaves are the dried leaves of the Ginkgo biloba plant (Ginkgoaceae family). They should meet the requirements for Ginkgo leaves in the 2020 edition of the Chinese Pharmacopoeia, Part I. Rich in ginkgo flavonoids and ginkgolides, they have the effects of improving microcirculation and anti-oxidation. When used as a substitute for pine needles, the dosage is 8-12 parts, for example, 8, 9, 10, 11, or 12 parts. All three of the above-mentioned medicinal materials have good antioxidant activity and can play a fundamental role in scavenging free radicals, reducing oxidative stress damage to hair follicles, and improving local microcirculation in the scalp.

[0063] Mulberry-derived medicinal materials play a role in dispersing wind-heat in this formula. Mulberry leaves or mulberry bark can be selected. Mulberry leaves are the dried leaves of the mulberry tree (Morus alba), and should conform to the requirements of the 2020 edition of the Chinese Pharmacopoeia, Volume I, under the Mulberry Leaf section. They are a preferred medicinal material in the basic formula. Their extracts have a certain regulatory effect on the hair follicle cycle and can also disperse wind-heat in the head and face. The dosage is 12-18 parts, for example, 12, 14, 15, 17, or 18 parts. Mulberry bark is the dried root bark of the mulberry tree (Morus alba), and should conform to the requirements of the 2020 edition of the Chinese Pharmacopoeia, Volume I, under the Mulberry Bark section. It is from the same source as mulberry leaves but a different part. The dosage is 10-14 parts, for example, 10, 11, 12, 13, or 14 parts. Externally, it has the effect of clearing heat and removing dampness, and helps improve scalp seborrhea. When used as a substitute for mulberry leaves, it provides another option while maintaining the overall efficacy of the formula.

[0064] The three herbs, Vitex trifolia or Cimicifuga, Pueraria lobata or Asarum heterotropoides, and Ligusticum striatum, serve as guiding herbs, forming a meridian-guiding group to direct the medicinal power of the entire formula to the key areas of the head. The dosage of Vitex trifolia is 10-14 parts, for example, 10, 11, 12, 13, or 14 parts. It is the dried, mature fruit of Vitex trifolia or Vitex negundo, a plant of the Verbenaceae family, and should comply with the provisions of the Vitex trifolia entry in Part I of the 2020 edition of the Chinese Pharmacopoeia. It has a bitter and slightly cold taste and enters the bladder, liver, and stomach meridians. It is light in nature and thin in taste, and rises upward, effectively dispersing wind-heat in the head and face, making it an essential herb for guiding the medicine to the head and face. Cimicifuga rhizome is an alternative to Vitex trifolia fruit, used in doses of 6-10 parts, such as 6, 7, 8, 9, or 10 parts, conforming to the provisions of the Cimicifuga rhizome entry in Part I of the 2020 edition of the Chinese Pharmacopoeia. It has a pungent and sweet taste, is slightly cold in nature, and enters the lung, spleen, stomach, and large intestine meridians. Its function is to ascend to the head and face, guiding the medicine upwards and dispersing, and it can be used as a guiding herb for the head and face. Kudzu root, used in doses of 8-12 parts, such as 8, 9, 10, 11, or 12 parts, is the dried root of the legume Pueraria lobata or Pueraria truncata. It should conform to the provisions of the Kudzu root entry in Part I of the 2020 edition of the Chinese Pharmacopoeia. It has a sweet and pungent taste, is cool in nature, and enters the spleen and stomach meridians. It is a guiding herb for the Yangming meridian, and its lightness allows it to ascend, guiding the medicinal power specifically to the forehead area. It also has pharmacological effects of improving microcirculation and anti-inflammation. Asarum is an alternative to kudzu root, used in doses of 3-7 parts, such as 3, 4, 5, 6, or 7 parts, conforming to the regulations under the Asarum section of the 2020 edition of the Chinese Pharmacopoeia. It is pungent and warm in nature, entering the heart, lung, and kidney meridians. Its pungent and warm properties allow it to penetrate deeply, promoting transdermal absorption. However, due to its content of safrole and other components, its dosage must be strictly controlled. Ligusticum striatum is used in doses of 6-10 parts, such as 6, 7, 8, 9, or 10 parts. It is the dried rhizome of Ligusticum striatum or Ligusticum lilyense, belonging to the Apiaceae family. It conforms to the regulations under the Ligusticum striatum section of the 2020 edition of the Chinese Pharmacopoeia. It is pungent and warm in nature, entering the bladder meridian and acting as a guiding herb for the Jueyin meridian, specifically targeting the top of the head, concentrating the medicinal effect in this area. The three groups of guiding herbs work together to form a targeted guidance system covering three key hair loss areas: the face, forehead, and crown. This allows the full efficacy of the formula to be concentrated in the anatomical areas with high hair follicle density and where hair loss most commonly occurs, thus improving the local bioavailability of the drug.

[0065] The hair growth herbal composition provided by this invention offers flexibility in dosage form selection, allowing it to be formulated as a tincture, spray, gel, or film-forming agent according to the usage scenario and medication habits. The tincture is the basic dosage form of this formula, prepared from the aforementioned twelve medicinal herbs through extraction with an ethanol-containing solvent. Ethanol, as a solvent, can simultaneously dissolve both fat-soluble and alcohol-soluble active ingredients in the medicinal herbs. After application, it has multiple auxiliary effects, including disinfection and degreasing, pore dilation, and promoting transdermal drug penetration. The final product is a clear, brownish-red to brownish-brown liquid with a pungent odor. The spray involves filling the tincture into a container equipped with a spray pump, spraying it onto the scalp surface with each press, suitable for even administration to large areas of hair loss. The gel is prepared by appropriately concentrating the tincture and adding a gel matrix such as carbomer. After application, it is less prone to dripping, prolonging the drug's retention time on the scalp. The film-forming agent is made by adding film-forming materials such as polyvinyl alcohol to the tincture. After application, it forms a thin film that adheres to the scalp, providing occlusion and promoting penetration. It is used before bedtime and removed in the morning.

[0066] The hair growth herbal composition provided by this invention can be prepared by the following steps:

[0067] (1) After cleaning each raw material, crush or cut it to obtain pretreated medicinal materials;

[0068] (2) Extract the pretreated medicinal materials obtained in step (1) with an ethanol solvent. The ethanol solvent is an aqueous solution of ethanol with a volume fraction of 55%-80%, and the amount used is such that the ratio of solvent volume to total weight of medicinal materials is 2:1 to 4:1.

[0069] (3) After extraction, separate the residue from the extract and collect the extract to obtain the final product.

[0070] In specific implementation, in step (1), each raw material is cleaned separately to remove impurities and non-medicinal parts. According to the tissue characteristics and texture of each medicinal material, it is processed by crushing or cutting. Among them, the leaves of fresh arborvitae, the pine needles in the wind-dispelling and antioxidant medicinal materials, and the mulberry leaves in the mulberry family are leaf or needle-leaf medicinal materials. After cleaning, they can be cut into segments with a length of 1.0-2.0cm, such as 1.0cm, 1.5cm, and 2.0cm. The fresh ginger in the warming and invigorating medicinal materials is a fresh rhizome medicinal material. After cleaning, it is cut into thin slices with a thickness of 2.0-3.0mm, such as 2.0mm, 2.5mm, and 3.0mm. The remaining medicinal materials are dried slices with a relatively hard texture. They are processed by crushing and sieving. The mesh size of the sieve after crushing is 10-20 mesh, such as 10 mesh, 15 mesh, and 20 mesh. If the warming and invigorating medicinal materials are dried ginger or galangal, they should be pulverized and sieved as dried medicinal slices. If the wind-dispelling and antioxidant medicinal materials are cypress seeds, they should be crushed due to their rich fatty oil and oily texture. If the wind-dispelling and antioxidant medicinal materials are ginkgo leaves, they can be cut into sections as leaf-type medicinal materials. If the mulberry medicinal materials are mulberry bark, which is a root bark, they can be pulverized and sieved as dried medicinal slices. Through the above pretreatment, the specific surface area of ​​the medicinal materials is increased, which is conducive to the full contact between the solvent and the medicinal materials and the efficient dissolution of active ingredients during the subsequent extraction process.

[0071] In step (2), the pretreated medicinal materials obtained in step (1) are mixed and placed in an extraction container. An ethanol-containing solvent is added to completely submerge the medicinal materials, with the liquid level 2-3 cm above the surface of the materials. After sealing, the mixture is left to stand and extract under light-protected conditions at 15-25°C. The soaking time is 14-28 days, for example, 14, 17, 21, 25, and 28 days. During the soaking period, intermittent shaking is performed daily for 1-3 minutes each time to prevent the powder from settling and caking at the bottom of the container, ensuring uniform extraction. The ethanol-containing solvent is an aqueous solution of ethanol with a volume fraction of 55%-80%, for example, 55%, 60%, 65%, 70%, 75%, and 80%. Preferably, the ethanol-containing solvent is 75% medical ethanol or commercially available high-proof liquor above 50°. The amount of solvent used is such that the ratio of solvent volume to the total weight of the medicinal materials is 2:1 to 4:1, for example, 2:1, 2.5:1, 3:1, 3.5:1, and 4:1. The immersion conditions at room temperature and away from light can effectively protect heat-sensitive and photosensitive components from degradation. The longer immersion period allows the solvent to fully penetrate into the tissues of various medicinal materials, gradually dissolving and extracting a variety of active ingredients with different polarities and solubilities, such as flavonoids, phenolic acids, volatile oils, and gingerols.

[0072] In other embodiments, an ultrasonic treatment step can be added before static impregnation. After mixing the pretreated medicinal material with an ethanol-containing solvent, it is first ultrasonically treated at 20-50 kHz for 20-60 minutes, such as 20 kHz, 30 kHz, 40 kHz, or 50 kHz. The cavitation effect of ultrasound promotes the breaking of the cell walls of the medicinal material and the rapid release of active ingredients. After ultrasonic pretreatment, the subsequent impregnation time can be appropriately shortened to 7-14 days, such as 7 days, 10 days, 12 days, or 14 days, while the other operating conditions remain unchanged.

[0073] In step (3), after extraction, filter the residue with 4-6 layers of degreased gauze with a pore size of 150-250 μm, for example, 150 μm, 200 μm, and 250 μm, to separate the residue from the initial filtrate. Rinse the residue 2-3 times with fresh ethanol-containing solvent, each rinse being 20-30 mL, for example, 20 mL, 25 mL, and 30 mL, and collect the rinsing liquid. After rinsing, place the residue in a press and gently press, collecting the extract until no more liquid drips. Combine the initial filtrate, rinsing liquid, and extract, and allow the combined filtrate to settle at room temperature for 12-48 hours, for example, 12 hours, 24 hours, 36 hours, and 48 hours, allowing the fine precipitate to settle naturally. Collect the supernatant. The final product is a clear, brownish-red to brownish-brown liquid with a pungent odor, and an alcohol content of 55%-80% based on ethanol.

[0074] The hair growth herbal composition provided by this invention can also be prepared using a supercritical CO2 extraction-assisted preparation method. Details are as follows:

[0075] S1 uses supercritical CO2 to extract fresh arborvitae leaves, pine needles and chuanxiong, collects the extract, and retains the residue after extraction;

[0076] S2 Combine the extracted residue obtained in step S1 with the remaining raw materials and extract with an ethanol-containing solvent. The ethanol-containing solvent is an aqueous solution of ethanol with a volume fraction of 55%-80%. The amount used is such that the ratio of solvent volume to total weight of medicinal materials is 2:1 to 4:1. After extraction, separate the residue from the extract and collect the extract.

[0077] S3 combines the extract obtained in step S1 with the extract obtained in step S2 to obtain the final product.

[0078] In step S1, three medicinal materials rich in volatile components—fresh arborvitae leaves, pine needles, and Sichuan lovage rhizome—are selected, cleaned, and appropriately pulverized. These materials are then placed in a supercritical CO2 extraction apparatus and extracted for 1-4 hours under conditions of 15-35 MPa extraction pressure, 35-55℃ extraction temperature, and CO2 flow rate of 10-30 L / h. The extract is collected. The extract mainly consists of volatile oils and fat-soluble components from the aforementioned medicinal materials and is sealed and stored away from light for later use. The residue after extraction still retains abundant non-volatile active components; it is collected and sealed for storage to prevent residual volatile solvents and component loss.

[0079] In step S2, the extracted residue obtained in step S1 is combined with the remaining raw materials (Drynaria fortunei, Salvia miltiorrhiza, Angelica sinensis, Carthamus tinctorius, warming herbs, mulberry herbs, Vitex trifolia or Cimicifuga foetida, Pueraria lobata or Asarum heterotropoides, Ligusticum striatum) and operated according to steps (1) to (3) of the aforementioned preparation method. That is, each herb is first pretreated by cleaning, crushing or cutting, and then extracted by immersion in an ethanol-containing solvent at 15-25°C in the dark for 14-28 days. During the immersion period, the herbs are shaken intermittently every day. After the extraction, the herbs are filtered with defatted gauze, the residue is rinsed with fresh ethanol-containing solvent and pressed, all the filtrates are combined and allowed to settle for 12-48 hours, and the supernatant is taken as the extract. The specifications, amount and immersion conditions of the ethanol-containing solvent are the same as those of the aforementioned preparation method, and will not be repeated here.

[0080] In step S3, the supercritical CO2 extract obtained in step S1 is combined with the extract obtained in step S2, and the mixture is stirred thoroughly until the extract is completely dissolved or uniformly dispersed in the extract. This method, by extracting volatile and non-volatile components stepwise and then combining them, can more completely preserve the chemical components with different polarities and solubility characteristics in the whole formula, while avoiding the loss of volatile components during long-term impregnation.

[0081] In specific implementation, the hair growth traditional Chinese medicine composition provided by the present invention can also be prepared by water extraction and alcohol precipitation, including the following steps:

[0082] A1. All raw materials are decocted twice with water, and the decoctions are combined.

[0083] A2. Concentrate the decoction obtained in step A1 to a relative density of 1.10-1.15 (60℃).

[0084] A3 Add 95% ethanol to the concentrate to make the alcohol content reach 55%-65%, let it stand for 24 hours, and take the supernatant.

[0085] A4 After recovering the ethanol from the supernatant obtained in step A3, the volume is adjusted to the target volume with an ethanol-containing solvent to obtain the final product.

[0086] In step A1, after cleaning all the raw medicinal materials, grind or cut them appropriately and put them into a decoction container. Add water and decoct twice. For the first decoction, add water at a ratio of 6-10 times the total weight of the medicinal materials, for example, 6 times, 8 times, or 10 times, and decoct for 1-2 hours, for example, 1 hour, 1.5 hours, or 2 hours. For the second decoction, add water at a ratio of 4-8 times the total weight of the medicinal materials, for example, 4 times, 6 times, or 8 times, and decoct for 0.5-1.5 hours, for example, 0.5 hours, 1 hour, or 1.5 hours. After each decoction, filter through gauze, collect the decoction separately, and combine the two decoctions.

[0087] In step A2, the combined decoction obtained in step A1 is placed in an evaporation and concentration apparatus and concentrated under reduced pressure or normal pressure at 60-80℃ until the relative density is 1.10-1.15 (measured at 60℃), for example, 1.10, 1.12, 1.13, 1.15. The concentrated liquid is a dark brown viscous liquid. After standing and cooling to room temperature, proceed to the next step.

[0088] In step A3, 95% ethanol is slowly added to the concentrated solution obtained in step A2 while stirring, until the volume fraction of ethanol in the solution reaches 55%-65%, for example, 55%, 58%, 60%, 63%, or 65%. After the addition is complete, stirring continues to ensure thorough mixing. The solution is then sealed and allowed to stand at room temperature for 24 hours. During the alcohol precipitation process, water-soluble macromolecular impurities such as starch, protein, mucilage, and pectin in the aqueous extract coagulate and precipitate under the action of ethanol. After standing, the supernatant is separated from the precipitate by decanting or siphoning, and the supernatant is collected.

[0089] In step A4, the supernatant obtained in step A3 is placed in a distillation or vacuum concentration apparatus to recover ethanol at below 60°C until no alcohol odor remains, yielding a concentrated medicinal solution. An ethanol-containing solvent with a volume fraction of 55%-80%, such as 75% medical ethanol or 60-degree liquor, is added to the concentrated solution, and the volume is adjusted to a solvent-to-total-weight ratio of 2:1 to 4:1. The mixture is thoroughly mixed, allowed to stand, and the supernatant is collected. This method uses water as the initial extraction solvent, effectively extracting water-soluble active ingredients from the medicinal materials. The alcohol precipitation step removes a large amount of water-soluble impurities from the decoction. The final product still meets the alcohol content requirements for tinctures. While maintaining the advantages of the alcohol extraction system, it reduces the amount of ethanol used in the extraction stage, providing a technical reserve for the diversity of solvent selection during the production process.

[0090] Example 1: Preparation of basic formulation tincture

[0091] Weigh the raw materials according to the following proportions by weight: 40g of fresh arborvitae leaves, 30g of drynaria rhizome, 25g of salvia miltiorrhiza, 20g of angelica sinensis, 12g of chuanxiong rhizome, 8g of safflower, 25g of fresh ginger, 20g of pine needles, 15g of mulberry leaves, 12g of vitex fruit, 10g of kudzu root, and 8g of ligusticum striatum.

[0092] Select fresh or shade-dried current-year arborvitae leaves, pine needles, and mulberry leaves, remove dead branches and impurities, quickly wash with clean water, and air dry in a cool, ventilated place. Cut into sections 1.0-2.0cm in length. Select fresh mature ginger, wash away dirt and sand, and slice into thin slices 2.0-3.0mm thick. Coarsely grind the remaining medicinal slices (Drynaria fortunei, Salvia miltiorrhiza, Angelica sinensis, Ligusticum chuanxiong, Carthamus tinctorius, Vitex trifolia, Pueraria lobata, and Ligusticum striatum) in a high-speed universal grinder, pass through a 10-20 mesh sieve, and set aside the sieve-passing material.

[0093] Place all the treated medicinal materials into a clean, dry, brown wide-mouthed glass bottle. Measure 500 mL of 75% medical ethanol and slowly pour it along the bottle wall to completely submerge the medicinal materials, ensuring the liquid level is 2-3 cm above the material. Seal the bottle. Place the sealed bottle in a cool, dark, and well-ventilated place at room temperature (15-25℃) for 21 days to soak. During the soaking period, shake the bottle once a day for 2 minutes each time, alternating between upside-down shaking and horizontal rotation, with an amplitude of 5-10 cm, to ensure full contact between the medicinal materials and the solvent and prevent the powder from settling and caking.

[0094] After the soaking period, open the container and filter through 4-6 layers of medical degreased gauze (pore size approximately 150-250 μm). Collect the filtrate in a clean container. Wash the residue twice with 50 mL of fresh 75% ethanol (25 mL each time), and combine the washings. Gently press the residue in a screw press until no more liquid drips out, and combine all the filtrates. Let the combined filtrate stand at room temperature for 24 hours to allow the fine precipitate to settle naturally, and carefully decant the supernatant. Determine the alcohol content; it should be 70%-75% ethanol. Aliquot into brown glass bottles, seal, and store in a cool, dark place.

[0095] The finished product is a clear, brownish-red to brownish-brown liquid with a pungent aroma, a slight ginger-like spiciness, and a spicy taste.

[0096] Experiment 1: Inhibition of 5α-reductase type II (in vitro)

[0097] Human prostate microsomes were used as the enzyme source for 5α-reductase type II, in order to [ 14 [C]-testosterone was used as the substrate (final concentration 1 μM), and finasteride was used as the positive control (IC50). 50 =0.095 μM). The tincture prepared in Example 1 was diluted to three concentrations: 0.1 mg / mL, 1 mg / mL, and 10 mg / mL. These were then co-incubated with the enzyme source and substrate at 37°C for 30 minutes. The peak area of ​​DHT was detected by HPLC-UV, and the inhibition rate was calculated. Each group had six replicates. The raw data and statistical analysis results of the inhibition rates for each concentration group are shown in Table 1 below.

[0098] Table 1. Experimental data on inhibition of 5α-reductase type II

[0099]

[0100] One-way ANOVA: F=374.88, P=1.56×10⁻⁶ -13 Log-concentration-inhibition rate linear regression: R 2 =0.9997, P = 0.011; IC 50 Estimated: Approximately 3.5 mg / mL (based on dose-response trend).

[0101] The above results indicate that the tincture prepared in Example 1 inhibited human 5α-reductase type II activity in a dose-dependent manner within the concentration range of 0.1-10 mg / mL, with an inhibition rate of 68.34% ± 3.99% in the high concentration group (10 mg / mL), confirming its pharmacological effect of blocking dihydrotestosterone production and targeting the core cause of androgenetic alopecia.

[0102] Experiment 2: Human hair papilla cell proliferation experiment (in vitro)

[0103] Third-generation human dermal papilla cells were collected at a concentration of 5 × 10⁻⁶. 3 / wells were seeded in 96-well plates, with blank control group (complete culture medium), minoxidil positive control group (0.1 mM), low-dose group (0.1% dilution), medium-dose group (1% dilution), and high-dose group (10% dilution) of the tincture from Example 1, with 6 replicates for each group. After incubation at 37°C and 5% CO2 for 48 hours, OD was measured by MTT assay. 490 OD values ​​were used to calculate cell proliferation rate. OD values ​​for each group were also used. 490 The original data and statistical analysis results of the values ​​are shown in Table 2 below.

[0104] Table 2 Results of human dermal papilla cell proliferation experiment

[0105]

[0106] P-value: Compared with the control group; one-way ANOVA: F=892.45, P<0.001. Comparison between the high-dose tincture group and the minoxidil group: P=0.482, no statistically significant difference.

[0107] The results showed that all dose groups of the tincture prepared in Example 1 significantly promoted the proliferation of human dermal papilla cells in a dose-dependent manner. The high-dose group (10% dilution) achieved a proliferation rate of 159.0%, comparable to the minoxidil positive control group, confirming its pharmacological effects in promoting hair follicle cell proliferation and prolonging the hair follicle growth phase.

[0108] Experiment 3: DPPH Free Radical Scavenging Experiment (In Vitro)

[0109] A 0.1 mM DPPH ethanol solution was prepared, and the tincture prepared in Example 1 was diluted to three concentrations: 0.1 mg / mL, 1.0 mg / mL, and 10.0 mg / mL, with vitamin C (VC) as a positive control. Each test sample was mixed with an equal volume of DPPH solution and reacted at room temperature in the dark for 30 minutes. The absorbance was measured at 517 nm, and the clearance rate was calculated. Six replicates were set for each group. The raw data and statistical analysis results of the clearance rates for each group are shown in Table 3 below.

[0110] Table 3 Results of DPPH free radical scavenging experiment

[0111]

[0112] Dose-response relationship: R² = 0.998, P < 0.01.

[0113] The results showed that the tincture prepared in Example 1 had a significant DPPH free radical scavenging ability in a dose-dependent manner, with the high concentration group (10 mg / mL) achieving a scavenging rate of 78.0% ± 1.1%, confirming its pharmacological effects of antioxidation and reducing oxidative stress damage to hair follicles.

[0114] Experiment 4: C57BL / 6 mouse androgenetic alopecia model experiment (animals)

[0115] Eight-week-old female C57BL / 6 mice were used to remove hair from their backs to create a 2cm×2cm hairless area. Starting the next day, 5% testosterone propionate tincture (0.1mL / mouse / day) was applied topically for 21 consecutive days to establish an androgenic alopecia model. Mice that successfully developed the model were randomly divided into seven groups: a normal control group (no hair removal, no modeling, no medication); a model control group (hair removal and application of testosterone propionate, no medication); a minoxidil group (hair removal and application of testosterone propionate, plus 0.2 mL of 5% minoxidil tincture twice daily); a low-dose tincture group (hair removal and application of testosterone propionate, plus 0.1 mL of tincture from Example 1 twice daily); a high-dose tincture group (hair removal and application of testosterone propionate, plus 0.2 mL of tincture from Example 1 twice daily); a plum blossom needle group (hair removal and application of testosterone propionate, plus plum blossom needle tapping three times a week); and a combined treatment group (hair removal and application of testosterone propionate, plus 0.2 mL of tincture from Example 1 twice daily after plum blossom needle tapping, plus plum blossom needle tapping three times a week).

[0116] The drug administration period for each group was 21 days. Daily observations were made of changes in the skin color on the backs of mice (a change from pink to gray and then to black indicates the transition of hair follicles from the resting phase to the anagen phase), and a blind hair growth score (0-4 points) was performed. Mice were sacrificed after drug administration, and back skin tissue was collected for HE staining to observe hair follicle morphology, count the ratio of anagen to resting phase hair follicles, and measure hair follicle diameter. Immunohistochemistry was used to detect the expression of vascular endothelial growth factor and insulin-like growth factor-1 in the hair follicles, and serum dihydrotestosterone levels were detected by ELISA.

[0117] The results showed that, compared with the model control group, the mice in the combined treatment group had the earliest entry of the back skin into the growth phase, the highest hair growth score, a significantly increased proportion of hair follicles in the growth phase, an increased hair follicle diameter, decreased serum DHT levels, and upregulated expression of VEGF and IGF-1.

[0118] Experiment 5: Clinical Observation Trial

[0119] To verify the clinical efficacy of the hair growth herbal composition provided by this invention, a clinical observation study was conducted. Forty-five patients with androgenetic alopecia, classified as Hamilton-Norwood grade II-IV, were randomly divided into three groups of 15 patients each. There were no statistically significant differences in hair density, average hair diameter, and the ratio of vellus hair to terminal hair at baseline among the three groups, making them comparable.

[0120] During the treatment, patients in Group A applied the tincture (10mg / mL) prepared in Example 1 twice a day, morning and evening. Each time, 1.5-2.0mL was applied evenly to the scalp in the hair loss area and massaged in a circular motion with the fingertips for 3-5 minutes until the scalp felt warm and slightly red. Patients in Group B received only plum blossom needle tapping therapy. They sat with their scalp exposed and disinfected with 75% ethanol. They then used a plum blossom needle to tap along the hair loss area in a circular motion from the periphery to the center, and then tapped longitudinally along the meridians. The intensity was such that the local scalp became flushed and slightly congested. Each tapping session lasted 5-10 minutes and was performed 2-3 times a week. Patients in Group C received the same plum blossom needle tapping as Group B, and immediately applied the tincture in the same manner as Group A. They received plum blossom needle tapping 2-3 times a week and applied the tincture twice a day. All three treatment courses lasted 12 weeks. Trichoscopy was the primary evaluation tool to observe changes in hair density, average hair diameter, and the ratio of vellus hair to terminal hair. Patient self-assessment questionnaires and physician overall evaluations were used as supplementary evaluation indicators. The trichoscopy results for each treatment stage are shown in Tables 4-9 below:

[0121] Table 4 Results of Clinical Observation Trials

[0122]

[0123] The results of the intergroup comparisons at 12 weeks are shown in Table 5 below.

[0124] Table 5. Results of intergroup comparisons at 12 weeks

[0125]

[0126] The results of the patient self-assessment questionnaire at 12 weeks are shown in Table 6 below (VAS score 0-10, the lower the score, the milder the symptoms).

[0127] Table 6. Results of Patient Self-Rating Questionnaire at Week 12

[0128]

[0129] The results of the doctor's overall assessment at 12 weeks are shown in Table 7 below.

[0130] Table 7. Physician's overall assessment results at 12 weeks

[0131]

[0132] Note: The effective rate is significant improvement + moderate improvement.

[0133] Adverse reaction records are shown in Table 8 below.

[0134] Table 8 Adverse Reaction Records

[0135]

[0136] Note: All adverse reactions were mild, resolved spontaneously, and did not affect treatment.

[0137] The treatment process data for typical cases (Group C) are shown in Table 9 below:

[0138] Table 9. Treatment process data for typical cases

[0139]

[0140] As can be seen from the results in Tables 4-9, the combined treatment group (Group C) was significantly better than the two individual treatment groups in terms of hair density, hair diameter, ratio of vellus hair to terminal hair, and patient subjective scores. Furthermore, the improvement exceeded the sum of the improvements in the simple tincture group and the simple plum blossom needle group, indicating a clear synergistic effect between the hair growth herbal composition of this invention and plum blossom needle tapping. The material basis for this synergistic effect lies in the rational combination and functional division of the components in the hair growth herbal composition of this invention.

[0141] The simple tincture group achieved sustained growth in hair density and diameter within 12 weeks, indicating that the hair growth herbal composition of the present invention already possesses observable pharmacological activity without physical penetration enhancement. This performance corroborates the aforementioned in vitro experimental results—the composition's inhibition of 5α-reductase type II, promotion of human dermal papilla cell proliferation, and scavenging ability of DPPH free radicals translate into actual hair growth promotion effects in the human scalp environment. The simple plum blossom needle group also showed some improvement, but its 12-week effective rate was less than 50%, indicating that while single physical tapping can temporarily activate local microcirculation and hair follicle stem cells, it lacks the pharmacological support for sustained inhibition of the causes of hair loss, and its efficacy has a ceiling.

[0142] The combined treatment group achieved an efficacy rate of 86.7%, and a significant decrease in the proportion of vellus hair was observed after 4 weeks of treatment, with an onset of action earlier than the two individual treatment groups. This phenomenon indicates that the microchannels pre-formed in the stratum corneum by the plum blossom needle tapping allow the active ingredients in the applied composition to enter the tissue surrounding the hair follicles more efficiently, effectively increasing the drug concentration at the target site with the same dosage. The early signal of the hair follicle transition from the resting phase to the anagen phase triggered by the tapping allows the subsequent pharmacological effects of the arborvitae leaf flavonoids inhibiting dihydrotestosterone production and the active ingredients of Drynaria fortunei promoting the proliferation of dermal papilla cells to act on the target cells that are already in a responsive state, thus achieving a combination of physical initiation and chemical follow-up within the time window.

[0143] The combined treatment group showed greater improvement in subjective scores regarding scalp itching, oiliness, and hair loss compared to the two individual treatment groups, confirming the existence of this synergistic effect from the perspective of patient experience. The improvement in subjective symptoms is related to the inhibition of scalp pathogens by 6-gingerol contained in fresh ginger in the combination, as well as the improvement of microcirculation by blood-activating herbs such as danshen and angelica. These effects were more fully realized under the conditions of plum blossom needle penetration enhancement.

[0144] Based on the above experimental data, it can be seen that the hair growth herbal composition provided by this invention has a dose-dependent inhibitory effect on human 5α-reductase type II activity (IC50). 50 Approximately 3.5 mg / mL), it can reduce the production of dihydrotestosterone; it has a significant promoting effect on the proliferation of human dermal papilla cells, with the proliferation rate of the high-dose group being comparable to that of the minoxidil positive control group; it also has the ability to scavenge DPPH free radicals (IC50). 50(Approximately 3.8 mg / mL), it can alleviate oxidative stress damage around hair follicles. These three activities stem from the rational combination of the various herbs in the formula: the flavonoids in Platycladus orientalis leaves play a major role in inhibiting 5α-reductase; the active ingredients in Drynaria fortunei promote the proliferation of dermal papilla cells and the expression of vascular endothelial growth factor; tanshinone, ligustrazine, and safflower yellow pigment synergistically improve scalp microcirculation; antioxidant components such as pine needle proanthocyanidins help scavenge free radicals; and 6-gingerol and gingerone in fresh ginger inhibit pathogenic bacteria on the scalp and improve the local microenvironment. Each component has its own focus while also being interconnected, forming a pharmacological network covering four aspects: inhibiting the cause, promoting regeneration, improving microcirculation, and providing antioxidant protection.

[0145] In clinical observation, patients using the composition alone showed a significant increase in hair density and diameter after 12 weeks of treatment, with an effectiveness rate of 33.3%, indicating that the composition itself has a definite hair growth promoting effect without the aid of physical penetration enhancement. When used in combination with plum blossom needle tapping, the effectiveness rate increased to 86.7%, and the improvement in various indicators exceeded the sum of the effects of using the composition alone and using plum blossom needle alone, while the onset time was also significantly shortened. This result is closely related to the multi-target, multi-component pharmacological characteristics of the composition—the microchannels formed by plum blossom needle tapping in the stratum corneum provide a pathway for multiple active ingredients to simultaneously enter the tissues surrounding the hair follicles. The activation signal of hair follicle stem cells triggered by tapping puts the target cells in a proliferative response state. The simultaneous intervention of multiple components in the composition in inhibiting dihydrotestosterone production, promoting cell proliferation, improving microcirculation, and scavenging free radicals consolidates and prolongs this endogenous regeneration signal, ultimately forming a synergistic effect of physical penetration enhancement and chemical pharmacology.

[0146] It should be noted that the combined use of plum blossom needle tapping in the above clinical observation is only a preferred external application method for the composition of the present invention, and is not a limitation on the application form of the composition. Data from 12 weeks of treatment in the simple tincture group showed that the composition of the present invention can independently achieve sustained growth in hair density and diameter without the aid of any physical penetration-enhancing methods, and this effect has been adequately supported by its mechanism in in vitro experiments.

[0147] In the pharmaceutical field, the composition of this invention can be formulated into topical dosage forms such as tinctures, sprays, gels, or films, depending on the formulation requirements, for the treatment of hair loss diseases such as androgenetic alopecia, alopecia areata, telogen effluvium, postpartum alopecia, and stress-related alopecia. When using, the preparation can be directly applied to the scalp in the area of ​​hair loss, and circular massage with fingertips can be used to promote drug penetration. It can also be used in conjunction with physical therapy methods such as plum blossom needle therapy, microneedle rollers, laser hair growth caps, and electric dermal needles to further improve the transdermal absorption efficiency of the active ingredients through physical penetration enhancement.

[0148] In the field of hair care products, the composition of this invention can be added as a functional ingredient to daily chemical products such as shampoos, conditioners, scalp serums, and scalp sprays to prevent hair loss, promote hair growth, and improve the scalp microenvironment. The 6-gingerol and gingerone contained in fresh ginger in the composition have an inhibitory effect on scalp pathogens such as Malassezia, helping to reduce scalp seborrhea and itching; herbs that promote blood circulation, such as Salvia miltiorrhiza and Angelica sinensis, can improve scalp microcirculation and maintain the nutrient supply for healthy hair follicles; antioxidant components such as Platycladus orientalis leaf flavonoids and pine needle proanthocyanidins help reduce daily damage to the scalp caused by environmental factors and oxidative stress. The multi-target pharmacological characteristics of the composition enable it to exert hair growth-promoting effects in both pharmaceutical and daily chemical product carriers. Specific product types, combinations, and frequencies of use should not be construed as limiting the scope of protection of this invention.

[0149] In the above embodiments, the descriptions of each embodiment have different focuses. For parts that are not described in detail in a certain embodiment, please refer to the relevant descriptions in other embodiments.

[0150] The above description describes specific embodiments of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various equivalent modifications or substitutions within the technical scope disclosed in the present invention, and these modifications or substitutions should all be covered within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A hair growth herbal composition, characterized in that, Its active pharmaceutical ingredients include the following medicinal materials in parts by weight: 35-45 parts of fresh Platycladus orientalis leaves 25-35 parts of Drynaria fortunei 20-28 parts of Salvia miltiorrhiza Angelica sinensis 18-22 parts Chuanxiong 10-14 parts 6-10 parts safflower 10-28 portions of warming and invigorating medicinal herbs 8-22 parts of wind-dispelling and antioxidant medicinal herbs 10-18 parts of mulberry medicinal materials 10-14 parts of Vitex trifolia fruit or 6-10 parts of Cimicifuga rhizome. 8-12 parts of kudzu root or 3-7 parts of asarum; Ligusticum sinense 6-10 parts; The warming and invigorating medicinal material is selected from any one of fresh ginger, dried ginger, or galangal. The wind-dispelling and antioxidant medicinal materials are selected from any one of pine needles, cypress seeds, or ginkgo leaves.

2. The hair growth herbal composition according to claim 1, characterized in that, The amount of fresh ginger used is 18-28 parts, the amount of dried ginger used is 18-22 parts, or the amount of galangal used is 10-14 parts.

3. The hair growth herbal composition according to claim 1, characterized in that, The dosage of pine needles is 18-22 parts, the dosage of cypress seed kernels is 13-17 parts, or the dosage of ginkgo leaves is 8-12 parts.

4. The hair growth herbal composition according to claim 1, characterized in that, The medicinal materials of the mulberry family are mulberry leaves or mulberry bark, wherein the amount of mulberry leaves is 12-18 parts and the amount of mulberry bark is 10-14 parts.

5. The hair growth traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that, The dosage form of the hair growth herbal composition is a tincture, spray, gel, or coating.

6. A method for preparing the hair growth traditional Chinese medicine composition according to any one of claims 1 to 5, characterized in that, Includes the following steps: (1) After cleaning each raw material, crush or cut it to obtain pretreated medicinal materials; (2) Extract the pretreated medicinal materials obtained in step (1) with an ethanol solvent. The ethanol solvent is an aqueous solution of ethanol with a volume fraction of 55%-80%, and the amount used is such that the ratio of solvent volume to total weight of medicinal materials is 2:1 to 4:

1. (3) After extraction, separate the residue from the extract and collect the extract to obtain the final product.

7. The preparation method according to claim 6, characterized in that, Step (1) also includes: before pulverizing or cutting after cleaning, take fresh arborvitae leaves, wind-dispelling and antioxidant medicinal materials and chuanxiong, extract them with supercritical CO2, collect the extract, combine the extracted residue with the remaining raw materials, and then carry out subsequent pulverizing or cutting treatment to obtain pretreated medicinal materials. Step (3) also includes: combining the extract with the obtained extract solution to obtain the final product.

8. A method for preparing the hair growth traditional Chinese medicine composition according to any one of claims 1 to 5, characterized in that, Includes the following steps: (1) Boil all the medicinal materials in water twice, each time for 0.5-2 hours, and combine the decoctions; (2) The decoction obtained in step (1) is concentrated to a relative density of 1.10-1.15 at 60℃; (3) Add 95% ethanol to the concentrate to make the alcohol content reach 55%-65%, let it stand for 24 hours, and take the supernatant. (4) After recovering the ethanol from the supernatant obtained in step (3), dilute it with an ethanol aqueous solution with an ethanol volume fraction of 55%-80% until the ratio of solvent volume to total weight of medicinal materials is 2:1 to 4:

1.

9. The use of the hair growth traditional Chinese medicine composition according to any one of claims 1 to 5 in the preparation of a medicament for treating hair loss or a shampoo and conditioner for preventing hair loss and promoting hair growth.

10. A topical hair growth kit, characterized in that, Include: (a) The hair growth traditional Chinese medicine composition according to any one of claims 1 to 5; (b) Dermal needle.

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