A traditional Chinese medicine composition for preventing and treating androgenic alopecia, a preparation method and application thereof

Abstract

This invention belongs to the field of traditional Chinese medicine composition technology, and discloses a traditional Chinese medicine composition for preventing and treating androgenetic alopecia, its preparation method, and its application. The traditional Chinese medicine composition for preventing and treating androgenetic alopecia of this invention comprises the following raw medicinal materials in parts by weight: Gynostemma pentaphyllum 10-20 parts, Atractylodes macrocephala 6-12 parts, Poria cocos 9-15 parts, Glycyrrhiza uralensis 1.5-9 parts, Coix lacryma-jobi 9-30 parts, Artemisia capillaris 6-15 parts, Morus alba leaf 5-9 parts, Morus alba root bark 5-15 parts, Pueraria lobata root 9-15 parts, and Salvia miltiorrhiza root 5-15 parts. This invention's entire formula closely adheres to the core pathogenesis of "spleen and stomach damp-heat," focusing on the treatment principle of "strengthening the spleen and removing dampness, clearing heat and protecting hair," forming an organic whole to exert its effect; when applied to patients with androgenetic alopecia of the spleen and stomach damp-heat type, it shows significant therapeutic effect and high safety.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine composition technology, specifically to a traditional Chinese medicine composition for preventing and treating androgenetic alopecia, its preparation method, and its application. Background Technology

[0002] Androgenic alopecia (AGA), also known as androgenetic alopecia or seborrheic alopecia, is a characteristic type of hair loss with genetic factors and dependent on androgen action. It can affect both men and women. Clinically, it is characterized by thinning hair on the crown or sides of the forehead, with hair gradually becoming thinner, softer, sparser, and falling out. The hairline gradually recedes, accompanied by seborrhea, dandruff, and itching. In Traditional Chinese Medicine (TCM), androgenetic alopecia falls under the categories of "hair loss due to scalp rot" or "scalp rot and tinea." Initially, it is often characterized by blood heat and wind-dryness; if the condition persists, blood deficiency and wind-dryness may develop. Furthermore, damp-heat in the spleen and stomach, ascending along the meridians, or liver and kidney deficiency can also lead to this disease. The pathogenesis manifests in the hair, but the disease location is in the internal organs, especially closely related to the liver, spleen, and kidneys. The main syndrome differentiation types include blood heat and wind-dryness, blood deficiency and wind-dryness, damp-heat in the spleen and stomach, and liver and kidney deficiency.

[0003] Currently, routine clinical interventions for AGA mainly fall into four categories: Western medicine treatment, traditional Chinese medicine treatment, surgical hair transplantation, and physical therapy. Each of these approaches has insurmountable clinical drawbacks, as detailed below: (1) Western medicine treatment for androgenetic alopecia often uses oral finasteride, oral spironolactone, and topical minoxidil. However, Western medicine treatment for androgenetic alopecia has the following shortcomings: 1) Slow onset of action: finasteride and minoxidil require at least 6 months to observe efficacy, and spironolactone requires at least 12 months to observe efficacy; 2) Many adverse reactions: the main adverse reactions of finasteride include male breast development, testicular pain, allergic reactions, and impaired sexual function (erectile dysfunction, ejaculatory dysfunction, reduced ejaculation volume or decreased libido); the main adverse reactions of spironolactone include menstrual disorders, decreased libido, and breast tenderness; the main adverse reactions of minoxidil include hirsutism, irritation and allergic dermatitis; 3) Limited selectivity of oral drugs: men can only choose finasteride, and women can only choose spironolactone.

[0004] (2) Traditional Chinese medicine emphasizes syndrome differentiation and treatment. Inaccurate syndrome differentiation and misuse of drugs are common clinical drawbacks in AGA: 1) Misuse of tonifying drugs for damp-heat type: Patients with oily scalp, itchy scalp, bitter taste in mouth, and thick and greasy tongue coating may take traditional Chinese medicine for nourishing the liver and kidneys and blood (such as Liuwei Dihuang Pills and Yangxue Shengfa Capsules) indiscriminately, which will aggravate the stagnation of damp-heat in the body, increase the secretion of oily scalp, block the hair follicle opening, accelerate hair loss, and aggravate oily scalp and dandruff; 2) Misuse of heat-clearing and detoxifying drugs for deficiency-cold constitution: Patients with spleen and stomach deficiency-cold, fear of cold and loose stools may take heat-clearing and detoxifying drugs for a long time. Traditional Chinese medicines for dampness (such as Niuhuang Jiedu Pian and Longdan Xiegan Wan) can easily damage the spleen and stomach's digestive function, leading to insufficient production of qi and blood, which further depletes the qi and blood of the hair roots, resulting in persistent hair loss; 3) AGA is becoming more prevalent among younger people, with middle-aged and young AGA patients mainly suffering from spleen and stomach damp-heat type, while commercially available traditional Chinese medicines for treating hair loss are mostly for tonifying the liver and kidneys, making it difficult to find traditional Chinese medicines for treating spleen and stomach damp-heat type AGA; 4) The liver is under heavy burden: the main ingredients of commercially available traditional Chinese medicines for treating hair loss often contain Polygonum multiflorum, which may cause liver damage with long-term use.

[0005] (3) Hair transplant surgery is expensive and has a high barrier to entry; it is an invasive treatment, and there are risks of intraoperative bleeding, postoperative wound infection, edema and pain; it can only improve the appearance of local baldness and cannot cure it; the donor area has limited hair follicle resources and it is difficult to repair large areas of baldness.

[0006] (4) Physical therapy such as low-energy laser and microneedling can only slightly improve scalp blood circulation and relieve mild inflammation around hair follicles. It is only suitable for very early mild AGA and is basically ineffective for moderate to severe patients whose hair follicles have become miniaturized. In addition, it requires high-frequency and long-term physical therapy, which is costly.

[0007] Therefore, given the multiple shortcomings of existing treatment options, developing a scientifically formulated, rapidly effective, safe, non-toxic, and comprehensive traditional Chinese medicine composition for the prevention and treatment of androgenetic alopecia is of significant clinical value and practical necessity. Summary of the Invention

[0008] The purpose of this invention is to overcome the shortcomings of the prior art and provide a traditional Chinese medicine composition for preventing and treating androgenetic alopecia, its preparation method and application. This traditional Chinese medicine composition is used to treat androgenetic alopecia of the spleen and stomach damp-heat type.

[0009] To achieve the above objectives, the technical solution adopted by the present invention is as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for preventing and treating androgenetic alopecia, comprising the following raw medicinal materials in parts by weight: Gynostemma pentaphyllum 10-20 parts, Atractylodes macrocephala 6-12 parts, Poria cocos 9-15 parts, Glycyrrhiza uralensis 1.5-9 parts, Coix lacryma-jobi 9-30 parts, Artemisia capillaris 6-15 parts, Morus alba leaf 5-9 parts, Morus alba root bark 5-15 parts, Pueraria lobata 9-15 parts, Salvia miltiorrhiza 5-15 parts.

[0010] Gynostemma pentaphyllum: sweet, bitter, and cold in nature; it can invigorate qi and strengthen the spleen, resolve phlegm and relieve cough, and clear heat and detoxify. It is used for spleen deficiency syndrome and lung deficiency cough syndrome.

[0011] Raw Atractylodes macrocephala: sweet, bitter, and warm in nature; it can invigorate qi and strengthen the spleen, dry dampness and promote diuresis, stop sweating, and calm the fetus. It is used for spleen qi deficiency syndrome, spontaneous sweating due to qi deficiency, and threatened abortion due to spleen deficiency.

[0012] Poria cocos: sweet, bland, and neutral in nature; it can promote diuresis and eliminate dampness, strengthen the spleen, and calm the mind. It is used for edema, phlegm retention, spleen deficiency diarrhea, palpitations, and insomnia.

[0013] Licorice: Sweet and neutral in nature; it can tonify the spleen and replenish qi, resolve phlegm and stop cough, relieve spasms and pain, clear heat and detoxify, and harmonize the properties of other herbs. It is used for insufficient heart qi, irregular pulse, palpitations, spleen qi deficiency, cough and asthma, abdominal and limb spasms and pain, carbuncles and sores caused by heat toxins, sore throat, food and drug poisoning, and harmonize the properties of other herbs.

[0014] Job's tears: sweet, bland, and cool in nature; it can promote diuresis and eliminate dampness, strengthen the spleen, relieve numbness, clear heat and drain pus. It is used for edema, difficulty urinating, beriberi, spleen deficiency diarrhea, dampness-induced numbness and contracture, lung abscess, and intestinal abscess.

[0015] Artemisia capillaris: bitter, pungent, and slightly cold in nature; it can clear damp-heat, promote bile secretion, and reduce jaundice. It is used for jaundice and itchy skin sores.

[0016] Mulberry leaves: sweet, bitter, and cold in nature; they can dispel wind-heat, clear the lungs and moisten dryness, calm liver yang, and clear the liver and improve eyesight. They are used for wind-heat colds, the initial stage of febrile diseases, lung-heat coughs, dry-heat coughs, dizziness due to liver yang hyperactivity, and red and blurred vision.

[0017] Mulberry bark: sweet and cold in nature; it can purge lung heat, relieve asthma, promote diuresis, and reduce swelling. It is used for cough and asthma due to lung heat, and edema.

[0018] Kudzu root: sweet, pungent, and cool in nature; it can relieve muscle tension and reduce fever, promote rash eruption, generate fluids and quench thirst, and raise yang to stop diarrhea. It is used for fever due to external pathogens, stiff neck and back pain, incomplete measles eruption, thirst due to febrile diseases, thirst due to yin deficiency, diarrhea and dysentery due to heat, and diarrhea due to spleen deficiency.

[0019] Salvia miltiorrhiza: Bitter and slightly cold in nature; it can invigorate blood circulation and regulate menstruation, remove blood stasis and relieve pain, cool blood and reduce swelling, relieve irritability and calm the mind. It is used for irregular menstruation, amenorrhea and dysmenorrhea, postpartum abdominal pain due to blood stasis, heart pain due to blood stasis, abdominal pain, masses and accumulations, traumatic injuries, rheumatic arthralgia, carbuncles and boils, fever with irritability and delirium, palpitations and insomnia.

[0020] The traditional Chinese medicine composition of this invention is for androgenetic alopecia of the spleen and stomach damp-heat type. Clinical manifestations include damp hair, as if oiled or soaked in water, sometimes several hairs sticking together, greasy scales; red tongue, yellow and slightly greasy coating, and a soft and rapid pulse.

[0021] In this invention, the traditional Chinese medicine composition is based on strengthening the spleen. Gynostemma pentaphyllum combines the effects of invigorating qi and strengthening the spleen with clearing heat and detoxifying, which aligns with the pathogenesis of damp-heat and is low in cost and mild in nature. Combined with Atractylodes macrocephala, Poria cocos, Glycyrrhiza uralensis, Coix lacryma-jobi, and Artemisia capillaris, it exerts the effects of strengthening the spleen, removing dampness, and clearing heat. The treatment method of "clearing wind-heat in the lung meridian" is introduced. Since the lung governs the skin and hair, clearing lung heat helps nourish the scalp; therefore, mulberry leaves and mulberry bark are added to disperse wind-heat in the lung meridian. For those with damp-heat in the spleen and stomach who are prone to spleen deficiency and dampness obstruction, and failure of clear yang to ascend, kudzu root is added to raise yang qi to nourish the hair. Baldness is a manifestation of blocked collaterals; Salvia miltiorrhiza has the effect of activating blood and unblocking collaterals, so it is added to improve microcirculation in hair follicles and promote hair growth. The entire formula closely adheres to the core pathogenesis of "damp-heat in the spleen and stomach," and revolves around the treatment method of "strengthening the spleen, removing dampness, clearing heat, and protecting hair," forming an organic whole that works synergistically. The various components work synergistically to clear wind-heat from the lung meridian, raise yang qi, and promote blood circulation, thereby strengthening the spleen, removing dampness, clearing heat, and protecting hair. When applied to patients with androgenetic alopecia of the spleen and stomach damp-heat type, the effects are significant and the safety is better.

[0022] As a preferred embodiment of the traditional Chinese medicine composition for preventing and treating androgenetic alopecia according to the present invention, it comprises the following raw medicinal materials in parts by weight: Gynostemma pentaphyllum 12-20 parts, Atractylodes macrocephala 7-12 parts, Poria cocos 9-15 parts, Glycyrrhiza uralensis 2-8 parts, Coix lacryma-jobi 12-30 parts, Artemisia capillaris 6-14 parts, Morus alba leaf 5-9 parts, Morus alba root bark 6-15 parts, Pueraria lobata 10-15 parts, Salvia miltiorrhiza 6-15 parts.

[0023] As a further preferred embodiment of the traditional Chinese medicine composition for preventing and treating androgenetic alopecia according to the present invention, it comprises the following raw medicinal materials in parts by weight: 20 parts of Gynostemma pentaphyllum, 12 parts of raw Atractylodes macrocephala, 15 parts of Poria cocos, 6 parts of Glycyrrhiza uralensis, 30 parts of Coix lacryma-jobi, 6 parts of Artemisia capillaris, 9 parts of Morus alba leaves, 15 parts of Morus alba root bark, 15 parts of Pueraria lobata, and 15 parts of Salvia miltiorrhiza.

[0024] Secondly, the present invention provides a method for preparing the traditional Chinese medicine composition for preventing and treating androgenetic alopecia, comprising the following steps: (1) Take the raw medicinal materials separately and cut or crush them; (2) Take the processed raw medicinal materials, soak them in water and then decoct them; combine the decoctions obtained from the decoctions of each raw medicinal material to form a decoction; The amount of water added is 8-10 times the weight of the raw medicinal materials; (3) Filter the decoction, concentrate it, and dry it into powder; (4) The powder is divided and packaged to obtain the product.

[0025] In a preferred embodiment of the preparation method of the traditional Chinese medicine composition for preventing androgenetic alopecia according to the present invention, the cutting involves cutting the Gynostemma pentaphyllum, Artemisia capillaris, mulberry leaves, and mulberry bark into segments or shreds 1-3 cm long, and cutting the raw Atractylodes macrocephala, licorice, kudzu root, and Salvia miltiorrhiza into slices 2-4 mm thick; the pulverizing involves pulverizing Poria cocos and Coix seed into coarse powder of 10-24 mesh; the decoction involves first heating over high heat to boiling, then simmering over low heat for 0.5-2.5 hours; the filtration is performed using a 100-200 mesh filter; and the drying is performed using spray drying or vacuum drying.

[0026] Preferably, during the decoction process, the soaked raw medicinal materials and water are first placed in a decoction pot, heated to boiling over high heat, and then simmered over low heat for 1-1.5 hours. The first decoction is then filtered and collected. Next, 6-8 times the total weight of the medicinal materials is added to the dregs, heated to boiling over high heat, and then simmered over low heat for 0.5-1 hour. The second decoction is then filtered and collected.

[0027] Thirdly, the present invention provides a pharmaceutical preparation for preventing and treating androgenetic alopecia, comprising the traditional Chinese medicine composition for preventing and treating androgenetic alopecia described in the first aspect.

[0028] As a preferred embodiment of the pharmaceutical preparation described in this invention, it also includes pharmaceutically acceptable excipients.

[0029] As a further preferred embodiment of the pharmaceutical preparation described in this invention, the dosage form of the pharmaceutical preparation is powder, tablet, capsule, granule, pill, oral liquid or syrup.

[0030] Fourthly, the present invention applies the traditional Chinese medicine composition described in the first aspect and the pharmaceutical preparation described in the third aspect in the preparation of a drug for the prevention or treatment of androgenetic alopecia.

[0031] Preferably, the androgenetic alopecia is a treatment for androgenetic alopecia of the spleen and stomach damp-heat type.

[0032] As a preferred embodiment of the application described in this invention, the prevention or treatment also includes the combined use of topical minoxidil, which has a rapid onset of action, significant efficacy, few adverse reactions, and good safety, and can be widely promoted and applied in clinical practice.

[0033] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. The traditional Chinese medicine composition of the present invention has excellent effects: (1) Rapid onset of action: The traditional Chinese medicine compositions of the present invention can significantly promote hair growth in mice with androgenic alopecia, with a hair coverage rate of 95.3% on day 28, which is significantly better than commercially available similar products; the traditional Chinese medicine compositions of the present invention, combined with minoxidil, can achieve a total effective rate of 100% (of which the cure rate is 37%) in only 3 months (12 weeks), which is significantly shorter than the onset time of finasteride (6 months), spironolactone (12 months), and minoxidil (6 months) described in the background art. The combination of traditional Chinese medicine compositions and minoxidil can have a synergistic effect.

[0034] (2) High safety: The traditional Chinese medicine composition of this invention does not use Polygonum multiflorum. No liver damage or other significant adverse reactions were reported during clinical use. In a systemic observation of 100 cases, only 2 cases of transient and mild gastrointestinal discomfort occurred. The safety is significantly better than that of finasteride and spironolactone, which may cause sexual dysfunction and menstrual disorders.

[0035] (3) Highly targeted and effective: The Chinese medicine composition of the present invention is specifically designed for the clinically common syndrome of "spleen and stomach damp-heat". It fills the gap that most commercially available Chinese medicines for treating hair loss are mainly for tonifying the liver and kidneys, but do not have the function of strengthening the spleen, removing dampness and clearing heat. The theoretical basis is sufficient, and clinical verification shows that it is effective for this syndrome of androgenetic alopecia, with excellent treatment effect and high efficiency. Detailed Implementation

[0036] To better illustrate the objectives, technical solutions, and advantages of this invention, the invention will be further described below with reference to specific embodiments. Those skilled in the art should understand that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

[0037] Unless otherwise specified, the experimental methods used in the examples are conventional methods; the materials, reagents, and Chinese herbal raw materials used are all commercially available unless otherwise specified.

[0038] Example 1: A Traditional Chinese Medicine Composition This traditional Chinese medicine composition includes the following raw medicinal materials by weight: Gynostemma pentaphyllum 20g, Atractylodes macrocephala 12g, Poria cocos 15g, Glycyrrhiza uralensis 6g, Coix lacryma-jobi 30g, Artemisia capillaris 6g, Morus alba leaf 9g, Morus alba root bark 15g, Pueraria lobata root 15g, Salvia miltiorrhiza 15g.

[0039] The preparation method of this traditional Chinese medicine composition includes the following steps: (1) Preparation of raw medicinal materials Select raw medicinal materials, remove impurities, non-medicinal parts, and damaged or deteriorated raw medicinal materials, and then clean the raw medicinal materials to remove surface dust and dirt; cut Gynostemma pentaphyllum, Artemisia capillaris, mulberry leaves, and mulberry bark into 2cm long segments or shreds; cut raw Atractylodes macrocephala, licorice, kudzu root, and Salvia miltiorrhiza into 3mm thick slices; and grind Poria cocos and Coix seed into 24-mesh coarse powder.

[0040] (2) Decoction Weigh out the prepared raw medicinal materials separately, add water equal to 9 times the total weight of the materials and soak for 60 minutes to allow the materials to fully absorb water and swell. Put the soaked materials and water into a decoction pot, heat over high heat until boiling, then reduce to low heat and simmer for 1 hour. Filter and collect the first decoction. Add water equal to 8 times the total weight of the materials to the dregs, heat over high heat until boiling, then reduce to low heat and simmer for 1 hour. Filter and collect the second decoction. Combine the two decoctions to form a decoction.

[0041] (3) Concentration The decoction is filtered using a 100-mesh filter to remove dregs, impurities, and suspended solids; the filtered decoction is then concentrated by heating and evaporation to remove most of the water.

[0042] (4) Drying The water in the concentrated medicinal liquid is removed by spray drying or vacuum drying to obtain the powder of the traditional Chinese medicine composition, while maintaining the effective components and efficacy of the medicinal liquid.

[0043] (5) Configuration and Packaging The traditional Chinese medicine composition powder is divided into oral dosage forms and packaged to form an oral dosage form.

[0044] Example 2: A Traditional Chinese Medicine Composition This traditional Chinese medicine composition includes the following raw medicinal materials by weight: Gynostemma pentaphyllum 12g, Atractylodes macrocephala 7g, Poria cocos 10g, Glycyrrhiza uralensis 2g, Coix lacryma-jobi 12g, Artemisia capillaris 7g, Morus alba leaf 6g, Morus alba root bark 6g, Pueraria lobata 10g, Salvia miltiorrhiza 6g.

[0045] The preparation method of this traditional Chinese medicine composition is the same as that in Example 1.

[0046] Example 3: A Traditional Chinese Medicine Composition This traditional Chinese medicine composition includes the following raw medicinal materials by weight: Gynostemma pentaphyllum 18g, Atractylodes macrocephala 10g, Poria cocos 14g, Glycyrrhiza uralensis 8g, Coix lacryma-jobi 25g, Artemisia capillaris 14g, Morus alba leaf 8g, Morus alba root bark 14g, Pueraria lobata 14g, Salvia miltiorrhiza 14g.

[0047] The preparation method of this traditional Chinese medicine composition is the same as that in Example 1.

[0048] Example 4: A Traditional Chinese Medicine Composition This traditional Chinese medicine composition includes the following raw medicinal materials by weight: Gynostemma pentaphyllum 15g, Atractylodes macrocephala 12g, Poria cocos 9g, Glycyrrhiza uralensis 5g, Coix lacryma-jobi 30g, Artemisia capillaris 10g, Morus alba leaf 5g, Morus alba root bark 12g, Pueraria lobata 12g, Salvia miltiorrhiza 10g.

[0049] The preparation method of this traditional Chinese medicine composition is the same as that in Example 1.

[0050] Comparative Example 1: A Traditional Chinese Medicine Composition This traditional Chinese medicine composition includes the following raw medicinal materials by weight: Gynostemma pentaphyllum 25g, Atractylodes macrocephala 12g, Poria cocos 15g, Glycyrrhiza uralensis 6g, Coix lacryma-jobi 30g, Artemisia capillaris 6g, Morus alba leaf 9g, Morus alba root bark 15g, Pueraria lobata root 15g, Salvia miltiorrhiza 15g.

[0051] The preparation method of this traditional Chinese medicine composition is the same as that in Example 1.

[0052] Comparative Example 2: A Traditional Chinese Medicine Composition This traditional Chinese medicine composition includes the following raw medicinal materials by weight: Gynostemma pentaphyllum 5g, Atractylodes macrocephala 12g, Poria cocos 15g, Glycyrrhiza uralensis 6g, Coix lacryma-jobi 30g, Artemisia capillaris 6g, Morus alba leaf 9g, Morus alba root bark 15g, Pueraria lobata root 15g, Salvia miltiorrhiza 15g.

[0053] The preparation method of this traditional Chinese medicine composition is the same as that in Example 1.

[0054] Comparative Example 3: A Traditional Chinese Medicine Composition This traditional Chinese medicine composition includes the following raw medicinal materials by weight: Gynostemma pentaphyllum 20g, Atractylodes macrocephala 12g, Poria cocos 15g, Glycyrrhiza uralensis 6g, Coix lacryma-jobi 30g, Artemisia capillaris 6g, Pueraria lobata 15g, Salvia miltiorrhiza 15g.

[0055] The preparation method of this traditional Chinese medicine composition is the same as that in Example 1.

[0056] Comparative Example 4: A Traditional Chinese Medicine Composition This traditional Chinese medicine composition includes the following raw medicinal materials by weight: Gynostemma pentaphyllum 20g, Atractylodes macrocephala 12g, Poria cocos 15g, Glycyrrhiza uralensis 6g, Coix lacryma-jobi 30g, Artemisia capillaris 6g, Morus alba leaf 9g, Morus alba root bark 15g, Salvia miltiorrhiza 15g.

[0057] The preparation method of this traditional Chinese medicine composition is the same as that in Example 1.

[0058] Comparative Example 5: A Traditional Chinese Medicine Composition This traditional Chinese medicine composition includes the following raw medicinal materials by weight: Gynostemma pentaphyllum 20g, Atractylodes macrocephala 12g, Poria cocos 15g, Glycyrrhiza uralensis 6g, Coix lacryma-jobi 30g, Artemisia capillaris 6g, Morus alba leaf 9g, Morus alba root bark 15g, Pueraria lobata root 15g.

[0059] The preparation method of this traditional Chinese medicine composition is the same as that in Example 1.

[0060] Comparative Example 6: A Traditional Chinese Medicine Composition This traditional Chinese medicine composition includes the following raw medicinal materials by weight: Angelica sinensis 8g, Rehmannia glutinosa 6g, Ligusticum chuanxiong 4g, Morus alba 6g, Astragalus membranaceus 8g, black sesame 12g, Morus alba leaf 4g, processed Polygonum multiflorum 12g, Cuscuta chinensis 6g, Lycium barbarum 6g, Platycladus orientalis leaf 6g, Rehmannia glutinosa (processed) 10g, Ligustrum lucidum 8g, Eclipta prostrata 8g, Spatholobus suberectus 6g.

[0061] The preparation method of this traditional Chinese medicine composition refers to the legal process of "Nourishing Hair Growth Tablets" in the "Drug Standards of Traditional Chinese Medicine Compound Preparations" issued by the Ministry of Health, while maintaining consistency with the dosage form in Example 1. The preparation steps are as follows: (1) Processing of black sesame seeds: Take the prescribed amount of black sesame seeds, grind them into fine powder separately, and set aside; (2) Water decoction extraction: Weigh and mix the remaining 14 raw medicinal materials, including Angelica sinensis, Rehmannia glutinosa, and Ligusticum chuanxiong, add water and soak for 60 minutes. Then heat to boiling and simmer twice. Combine the filtrates to form the extract decoction. (3) Concentration and drying: After filtering the above decoction, heating and evaporating to concentrate and remove water, the extract powder is dried by vacuum drying (or spray drying). (4) Mixing and packaging: The black sesame powder obtained in step (1) and the extract powder obtained in step (3) are thoroughly mixed and packaged into the same oral powder dosage form as in Example 1.

[0062] Experimental example: Animal experiments (1) Animal model construction and dosing regimen To verify the therapeutic effect of a traditional Chinese medicine composition on androgenetic alopecia, an AGA model induced by testosterone propionate in C57BL / 6J mice was established. Six-week-old male C57BL / 6 mice (weighing 20±2g) were housed in an SPF-grade animal facility, maintaining a temperature of 22±2℃, humidity of 50%±10%, a 12-hour light-dark cycle, and providing ample food and water.

[0063] Experimental mice were grouped into 12 groups, including blank control group, model control group, Example 1 group, Example 2 group, Example 3 group, Example 4 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, Comparative Example 5 group and Comparative Example 6 group, with 10 mice in each group.

[0064] Modeling method: Hair was removed from the backs of all mice (area 5cm × 3cm); the blank control group was injected subcutaneously with physiological saline daily, while the other groups were injected subcutaneously with testosterone propionate (25mg / kg) at the same time every day.

[0065] Dosage and method of administration: The oral preparation of the traditional Chinese medicine composition was administered by gavage. The dosage was calculated based on the body weight of the mice. In the examples and comparative groups, the dosage was 10g of raw drug / kg body weight / day, once a day, for 28 consecutive days.

[0066] Results observation: Hair regrowth was observed and photographed on days 7, 14, 21, and 28. The study ended on day 28, and mice were euthanized under inhalation anesthesia via cervical dislocation.

[0067] (2) Experimental results On days 7, 14, 21, and 28, the hair regeneration in the bald areas on the backs of mice in each group was observed and recorded, and the hair coverage rate was calculated.

[0068] Hair coverage rate = area of ​​new hair growth in the hair removal area ÷ total area of ​​original hair removal × 100%.

[0069] The results are shown in Table 1.

[0070] Table 1 Comparison of hair coverage rates in different groups of mice at different time points (x±s,%, n=10) The hair coverage rate of the model control group mice was only 4.5% on day 7 after modeling, 5.9% on day 14, 5.3% on day 21, and 4.0% on day 28, which was significantly lower than that of the blank control group. P The result was <0.01, indicating that testosterone propionate successfully induced androgenetic alopecia in mouse models, and hair growth was significantly inhibited.

[0071] In Example 1, the hair coverage rate of mice in group 1 reached 28.3% on day 7 after drug administration, which was significantly higher than that of the model control group (4.5%). P <0.01); the hair coverage rate reached 58.4% on day 14, 82.7% on day 21, and 95.3% on day 28, approaching the level of the blank control group. This indicates that the traditional Chinese medicine composition in Example 1 can significantly promote hair growth in androgenic alopecia mice. Examples 2-4 also showed significant hair growth promoting effects, with hair coverage rates of 88.2%, 85.8%, and 91.8% on day 28, respectively, all significantly higher than the model control group (…). P <0.01). Among them, the first group of examples showed the best effect, indicating that the preferred ratio has the best therapeutic effect.

[0072] On day 28, the hair coverage rate of mice in Comparative Example 1 was 55.3%, and that of mice in Comparative Example 2 was 52.5%, both significantly lower than that of Group 1 of Example (95.3%). P <0.01). This demonstrates that both excessively high and low levels of Gynostemma pentaphyllum can lead to a significant decrease in therapeutic efficacy.

[0073] On day 28, the hair coverage rate of mice in Comparative Example 3 was 62.0%, in Comparative Example 4 it was 58.3%, and in Comparative Example 5 it was 65.3%, all significantly lower than that in Example 1 (95.3%). P <0.01). This demonstrates that mulberry leaves, mulberry bark, kudzu root, and salvia miltiorrhiza play indispensable roles in this formula, reflecting the synergistic effect of traditional Chinese medicine combinations.

[0074] On day 28, the hair coverage rate of mice in the comparative group 6 was 70.0%, significantly lower than that in the example group 1 (95.3%). P <0.01), indicating that the herbal composition of the embodiment has a better hair growth promoting effect than commercially available hair growth supplement tablets.

[0075] In summary, the herbal compositions of Examples 1-4 all significantly promoted hair growth in mice with androgenetic alopecia, with Example 1 showing the best effect, achieving a hair coverage rate of 95.3% on day 28. Comparative Examples 1-2 and 3-5 showed significantly lower efficacy compared to Example 1, demonstrating a synergistic effect between these raw materials and other ingredients in the formula. Comparative Example 6 (commercially available hair-growth tonic tablets) showed significantly lower efficacy than Example 1, proving that the herbal composition of this invention is superior to existing technologies.

[0076] Trial example: Clinical trial From 2019 to 2024, 100 patients diagnosed with androgenetic alopecia (androgenetic alopecia / seborrheic alopecia) and diagnosed by traditional Chinese medicine as hair loss due to brittle hair and damp-heat syndrome of spleen and stomach were collected from the Department of Dermatology of Jiaxing First Hospital. The herbal composition of Example 1 was decocted using a closed decoction machine. The prescription was decocted once, and the decoction process was as follows: the corrected herbal pieces were placed in a cloth bag, soaked in cold water for at least 30 minutes, placed in the decoction machine, and decocted at high temperature for 60 minutes after adding water. During the decoction process, the decoction machine automatically squeezed instead of stirring. After decoction, the automatic squeezing and pressure inside the pot forced the medicine into a filling machine for packaging. One bag (150mL) was taken twice daily for 12 weeks, combined with topical minoxidil solution (Mandi).

[0077] All participants signed a written informed consent form. The gender and age distribution of the participants is detailed in Tables 2 and 3.

[0078] Table 2. Distribution of patients by gender Table 3. Age distribution of patients The criteria for determining efficacy were formulated with reference to the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines", as shown in Table 4.

[0079] Table 4. Criteria for Evaluating Therapeutic Effect

[0080] Clinical treatment results showed that the traditional Chinese medicine composition of Example 1, combined with minoxidil tincture, showed significant efficacy after 12 weeks (3 months), significantly shortening the onset time compared to finasteride tablets (6 months), spironolactone tablets (12 months), and minoxidil (6 months). Among these, 37 cases were cured (37% cure rate); 63 cases showed significant improvement (63% significant improvement rate); and 0 cases were ineffective. The total effective rate (cured + significantly improved) was 100%. During the treatment, one case experienced mild abdominal distension, and one case experienced mild diarrhea; both resolved spontaneously without special treatment, and no other significant adverse reactions were observed.

[0081] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A traditional Chinese medicine composition for preventing and treating androgenic alopecia, characterized in that, The raw medicinal materials include the following parts by weight: Gynostemma pentaphyllum 10-20 parts, Atractylodes macrocephala 6-12 parts, Poria cocos 9-15 parts, Glycyrrhiza uralensis 1.5-9 parts, Coix lacryma-jobi 9-30 parts, Artemisia capillaris 6-15 parts, Morus alba leaf 5-9 parts, Morus alba root bark 5-15 parts, Pueraria lobata 9-15 parts, Salvia miltiorrhiza 5-15 parts.

2. The traditional Chinese medicine composition for preventing and treating androgenic alopecia according to claim 1, characterized in that, The raw medicinal materials include the following parts by weight: Gynostemma pentaphyllum 12-20 parts, Atractylodes macrocephala 7-12 parts, Poria cocos 9-15 parts, Glycyrrhiza uralensis 2-8 parts, Coix lacryma-jobi 12-30 parts, Artemisia capillaris 6-14 parts, Morus alba leaf 5-9 parts, Morus alba root bark 6-15 parts, Pueraria lobata 10-15 parts, Salvia miltiorrhiza 6-15 parts. 3.The Chinese medicine composition for preventing and treating androgenic alopecia according to claim 2, characterized in that, The raw medicinal materials include the following parts by weight: 20 parts of Gynostemma pentaphyllum, 12 parts of raw Atractylodes macrocephala, 15 parts of Poria cocos, 6 parts of Glycyrrhiza uralensis, 30 parts of Coix lacryma-jobi, 6 parts of Artemisia capillaris, 9 parts of Morus alba leaves, 15 parts of Morus alba root bark, 15 parts of Pueraria lobata, and 15 parts of Salvia miltiorrhiza.

4. The preparation method of the traditional Chinese medicine composition for preventing and treating androgenic alopecia according to any one of claims 1-3, characterized in that, Includes the following steps: (1) Take the raw medicinal materials separately and cut or crush them; (2) Take the processed raw medicinal materials, soak them in water and then decoct them; combine the decoctions obtained from the decoctions of each raw medicinal material to form a decoction; (3) Filter the decoction, concentrate it, and dry it into powder; (4) The powder is divided and packaged to obtain the product.

5. The method for preparing the traditional Chinese medicine composition for preventing androgenetic alopecia according to claim 4, characterized in that, The cutting process involves cutting the Gynostemma pentaphyllum, Artemisia capillaris, mulberry leaves, and mulberry bark into 1-3 cm long segments or shreds, and cutting the raw Atractylodes macrocephala, licorice, kudzu root, and Salvia miltiorrhiza into 2-4 mm thick slices; the pulverizing process involves pulverizing Poria cocos and Coix seed into 10-24 mesh coarse powder; the decoction process involves first heating over high heat to boiling, then reducing to low heat and simmering for 0.5-2.5 hours; the filtration process uses a 100-200 mesh filter; and the drying process uses spray drying or vacuum drying.

6. A pharmaceutical preparation for preventing androgenetic alopecia, characterized in that, The traditional Chinese medicine composition for preventing and treating androgenetic alopecia as described in any one of claims 1-3.

7. The pharmaceutical preparation according to claim 6, characterized in that, It also includes pharmaceutically acceptable excipients.

8. The pharmaceutical preparation according to claim 6 or 7, characterized in that, The dosage form of the pharmaceutical preparation is powder, tablet, capsule, granule, pill, oral liquid or syrup.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-3 and the pharmaceutical preparation according to any one of claims 6-8 in the preparation of a medicament for the prevention or treatment of androgenetic alopecia.

10. The application according to claim 9, characterized in that, The prevention or treatment also includes the combined use of topical minoxidil.

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