Preparation method and application of traditional Chinese medicine composition for growing and nourishing hair

Abstract

The invention provides a preparation method and application of a traditional Chinese medicine composition for growing and nourishing hair, and belongs to the technical field of traditional Chinese medicines. In the formula, prepared rehmannia root and prepared fleeceflower root are used as monarch drugs, wine-processed glossy privet fruit, dodder and refined sealwort are used as ministerial drugs, ligusticum wallichii, peach kernel, safflower and white peony root are used as adjuvant drugs, and notopterygium root and pawpaw are used as conductant drugs. According to the traditional Chinese medicine composition for growing and nourishing hair, through mutual cooperation of pure natural traditional Chinese medicine raw materials, hair output of existing hair follicles can be promoted, the unit number of functional hair follicles can be increased in the modes of improving the microenvironment of the hair follicles, activating dormant hair follicles and the like, and the purposes of growing hair and nourishing hair are achieved; and the risk of relapse of alopecia is effectively reduced.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a method for preparing and applying a traditional Chinese medicine composition for hair growth and nourishment. Background Technology

[0002] Androgenetic alopecia (AGA), also known as seborrheic alopecia, is the most common type of hair loss. Its core pathological features are progressive miniaturization of hair follicles and shortening of the anagen phase. Clinically, in men, AGA often presents as a receding hairline and / or progressive thinning and reduction of hair in the occipital region, while in women, it typically presents as diffuse thinning and reduction of hair, primarily on the crown, often accompanied by excessive sebum secretion. Currently, the globally recognized first-line drug treatment is oral 5α-reductase inhibitors (finasteride) and topical vasodilators (minoxidil). However, these standard Western medicine treatments have many side effects. For example, long-term use of finasteride may cause sexual dysfunction and depressive tendencies, while minoxidil often causes contact dermatitis, local itching, and other allergic reactions, leading to poor patient compliance. Furthermore, these drugs can only partially slow down the hair loss process, and once discontinued, hair loss is very likely to recur, making fundamental reversal difficult.

[0003] Traditional Chinese medicine's understanding of hair loss has evolved over thousands of years, forming a unique theoretical system centered on holistic concepts and dialectical treatment. From the *Huangdi Neijing*, *Zhubing Yuanhou Lun*, *Shengji Zonglu*, and *Wai Ke Zhengzong* to the Qing Dynasty's *Yizong Jinjian*, physicians throughout history have continuously enriched their understanding of androgenetic alopecia, attributing its etiology and pathogenesis to liver and kidney deficiency and depletion of essence and blood as the root cause, and damp-heat rising upwards and phlegm and blood stasis as the superficial manifestations. These two aspects are mutually causal, resulting in a lingering and difficult-to-cure condition.

[0004] As a result, numerous traditional Chinese medicine formulas, tinctures, and related products claiming to promote hair growth have emerged in the market. However, existing TCM interventions also face some challenges: unstable efficacy and long treatment cycles: most formulas are slow to take effect, and the results vary from person to person, lacking stable and predictable hair growth effects; inconvenient dosage forms and poor user experience: traditional decoctions are cumbersome to prepare, and some topical preparations are greasy and have an unpleasant odor, affecting the convenience and comfort of daily use for patients; unclear mechanisms of action and lack of modern pharmacological evidence: the mechanisms of action of many products are still explained at the level of traditional theories, lacking empirical research support at the level of modern pharmacology and cell and molecular biology, leading to doubts about their scientific validity and effectiveness.

[0005] In conclusion, neither current standard Western medicine treatments nor commercially available traditional Chinese medicine products have ideally resolved the core contradiction in AGA treatment: safety, effectiveness, convenience, and radical cure. Therefore, there is an urgent clinical need for a novel therapeutic drug that integrates the essence of both Western and traditional Chinese medicine theories, has a clear mechanism of action, few side effects, is easy to use, and can fundamentally improve the hair follicle microenvironment and reverse the miniaturization process of hair follicles. Summary of the Invention

[0006] In view of this, the present invention provides a traditional Chinese medicine composition for hair growth and nourishment, the composition comprising the following raw materials in parts by weight: 15-24 parts of Rehmannia glutinosa (processed), 15-24 parts of Ligustrum lucidum (processed with wine), 15-24 parts of Polygonum multiflorum (processed), 15-24 parts of Cuscuta chinensis, 15-24 parts of Polygonatum sibiricum (processed), 3-9 parts of Paeonia lactiflora, 3-9 parts of Prunus persica, 3-9 parts of Carthamus tinctorius, 2-6 parts of Notopterygium incisum, 2-6 parts of Ligusticum chuanxiong, and 2-6 parts of Chaenomeles speciosa.

[0007] The above formula can be explained as follows: Rehmannia glutinosa and Polygonum multiflorum are the principal herbs, while Ligustrum lucidum, Cuscuta chinensis and Polygonatum sibiricum are the assistant herbs. The assistant herbs assist the principal herbs to replenish the essence and blood of the liver and kidneys, thus providing a source for growth. Ligusticum chuanxiong, Prunus persica, Carthamus tinctorius and Paeonia lactiflora are the adjuvant herbs to enhance the tonifying effect of the principal and assistant herbs. Notopterygium incisum and Chaenomeles speciosa are the guiding herbs to ensure that the tonifying and blood-activating herbs reach the affected area directly.

[0008] Furthermore, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 18 parts Rehmannia glutinosa (processed), 18 parts Ligustrum lucidum (processed with wine), 18 parts Polygonum multiflorum (processed), 18 parts Cuscuta chinensis, 18 parts Polygonatum sibiricum (processed), 6 parts Paeonia lactiflora, 6 parts Prunus persica, 6 parts Carthamus tinctorius, 3.6 parts Notopterygium incisum, 3.6 parts Ligusticum chuanxiong, and 3.6 parts Chaenomeles speciosa.

[0009] Rehmannia glutinosa nourishes yin and blood, replenishes essence and marrow; sufficient kidney essence provides a source for hair growth.

[0010] He Shou Wu (Polygonum multiflorum) nourishes the essence and blood, and benefits the liver and hair.

[0011] Privet fruit nourishes the liver and kidneys, replenishes yin and blood, and makes essence and blood more abundant.

[0012] Cuscuta seed nourishes the kidneys and replenishes essence, strengthens the Chong and Ren meridians, and prevents hair loss due to deficiency of essence and qi.

[0013] Polygonatum sibiricum replenishes qi and nourishes yin, and moisturizes hair.

[0014] Chuanxiong (Ligusticum striatum) invigorates blood circulation and promotes the flow of qi, guiding blood upwards to the top of the head.

[0015] Peach kernels and safflower can break up blood stasis, promote blood circulation, and promote the flow of new blood.

[0016] White peony root nourishes the blood and softens the liver, harmonizes the body's vital energy and defenses, and both aids in tonification and protects the blood and yin.

[0017] Papaya can relax muscles and tendons, and regulate qi and blood circulation.

[0018] Notopterygium root is pungent and warm in nature, and it is good at dispelling wind and dampness, reaching the head and neck.

[0019] The second aspect of this invention provides the application of a traditional Chinese medicine composition for promoting hair growth and nourishing hair in the preparation of a pharmaceutical formulation for improving hair loss symptoms.

[0020] The third aspect of this invention provides a method for preparing a traditional Chinese medicine preparation for hair growth and nourishment, comprising the following steps: (1) Preparation of ethanol extract of traditional Chinese medicine: S1. Weigh the raw materials; S2. Pre-treat the raw materials; S3. Impregnation and filtration: Transfer the pretreated raw materials obtained in step (S2) to a mixing tank. Add a certain amount of ethanol solution to the mixing tank and completely immerse the raw materials. Seal and impregnate the raw materials under certain conditions for 2-6 days, allow them to stand, and filter 1-3 times to obtain the ethanol extract of traditional Chinese medicine.

[0021] (2) Preparation: Add a certain amount of glycerol to the ethanol extract of Chinese medicine obtained in step (1) and stir until the glycerol and the extract are evenly mixed to obtain a pre-prepared product.

[0022] (3) Volume adjustment: Add ethanol to the pre-prepared solution obtained in step (2), stir again until the total volume of the liquid reaches the required volume, and obtain the traditional Chinese medicine preparation for hair growth and nourishment.

[0023] Furthermore, the preprocessing in step (S2) includes the following steps: a. Cleaning: Removing impurities from the raw materials to obtain clean medicinal materials; b. Crushing: The cleaned medicinal materials obtained in step a are crushed to obtain coarse powder in which all particles pass through a 24-mesh sieve and at least 60% pass through a 65-mesh sieve.

[0024] Furthermore, the impregnation and filtration in step S3 specifically include: (1) Impregnation: Transfer the pretreated raw material obtained in step (S2) to the mixing tank, add a certain amount of 70%-80% ethanol solution to the mixing tank, so that the ethanol liquid completely submerges the coarse powder of the medicinal material and is appropriately higher than its surface, stir to ensure that the medicinal material and ethanol are fully mixed, seal the container lid, and place it in a room temperature environment of 20-25℃ and in the dark for 84-108 hours. During the impregnation period, it is necessary to stir once every 12 hours, and stir slowly in the same direction for 5-10 minutes each time. (2) Filtration: Filter the medicinal liquid after soaking in step (1), take the filtrate, and squeeze the medicinal residue to obtain a secondary filtrate. Mix the two filtrates to obtain a mixed filtrate. (3) Standing: Let the mixed filtrate obtained in step (2) stand at room temperature (20-25℃) in the dark for 36-60 hours; (4) Secondary filtration: The mixed filtrate that has been allowed to stand in step (3) is filtered a second time, the supernatant is taken and the precipitate is discarded; the supernatant is filtered again to obtain the Chinese herbal ethanol extract.

[0025] Furthermore, the filtration in step (2) uses six layers of medical gauze; the supernatant in step (4) is filtered again using a fusion funnel (G1).

[0026] Furthermore, based on the aforementioned hair growth liniment, this invention further develops a hair growth gel process, the specific preparation steps of which are as follows: Take a certain amount of hair growth lotion, purified water, carbomer powder, and triethanolamine; Place purified water in a container, add carbomer powder while stirring to avoid clumping, stir for a certain period of time, stop stirring, seal the container, and let it stand at room temperature until the solution forms a uniform transparent gel without obvious particles, thus obtaining the gel matrix. Add the hair growth liniment to the transparent gel obtained in step (b), stir to fully mix the medicine with the gel matrix; while stirring, add triethanolamine dropwise until the solution forms a gel, stop adding triethanolamine, and continue stirring until the gel is uniform, delicate and glossy to obtain the gel.

[0027] The fourth aspect of the present invention provides the use of the above-mentioned traditional Chinese medicine composition or preparation in the preparation of a drug that improves hair production in patients' hair follicles, increases functional hair follicle units, and reduces the risk of hair loss recurrence.

[0028] Compared with the prior art, the present invention has at least the following advantages: (1) The hair growth and hair care composition provided by the present invention can not only promote the hair production of existing hair follicles, but also increase the number of functional hair follicles by improving the microenvironment of hair follicles and activating dormant hair follicles, thereby reversing the hair follicle miniaturization process, achieving the therapeutic effect of hair growth and hair care, and effectively reducing the risk of hair loss recurrence.

[0029] (2) The hair growth and hair care preparation provided by the present invention is convenient to use as a topical application. The active ingredients are all pure natural Chinese herbal medicines with relatively few side effects, making it suitable for long-term use. Compared with some chemical drugs, this reduces the potential risk of damage to organs such as the liver and kidneys.

[0030] (3) The preparation method of the hair growth and hair care traditional Chinese medicine preparation provided by the present invention is simple, generates less waste during the preparation process, and is suitable for mass production.

[0031] (4) The present invention further provides a traditional Chinese medicine gel for hair growth and nourishment, which overcomes the shortcomings of traditional liniments and enhances the safety and efficacy stability of the product. Attached Figure Description

[0032] The accompanying drawings, which form part of this invention, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an undue limitation of the invention. In the drawings: Figure 1 These are microscopic images of the scalp and hair of patients with hair loss before and after applying the topical Chinese herbal medicine preparation for hair growth and nourishment in the clinical study of this invention. Figure 2 These are microscopic images of the scalp and hair of patients with hair loss (2) before and after applying the topical Chinese medicine preparation for hair growth and nourishment in clinical research of this invention; Figure 3 These are microscopic images of the scalp and hair of patients with hair loss (3) before and after applying the topical Chinese medicine preparation for hair growth and nourishment in the clinical study of this invention. Figure 4 These are microscopic images of the scalp and hair of patients with hair loss (4) before and after applying the topical Chinese medicine preparation for hair growth and nourishment in the clinical study of this invention. Figure 5 This is a schematic diagram of bar graph analysis of scalp and hair microscopic images before and after the application of the topical hair growth and nourishing Chinese herbal preparation to patients with hair loss in the clinical study of this invention. Figure 6 This is a schematic diagram illustrating the effect of serum containing the hair growth and hair care traditional Chinese medicine preparations at concentrations of 20%, 25%, 30%, 35%, and 40% of the present invention on the proliferation of HFDPC. Figure 7 This is a schematic diagram illustrating the effect of serum containing the 25% hair growth and nourishing traditional Chinese medicine preparation of the present invention on CyclinD1 gene expression; Figure 8 This is a schematic diagram illustrating the effect of the hair growth and nourishing traditional Chinese medicine preparation of the present invention on skin color and hair growth in the hair-loss area of ​​mice; Figure 9 This is a schematic diagram illustrating the effect of the hair growth and nourishing traditional Chinese medicine preparation of the present invention on the hair length and density in the hair loss area of ​​mice; Figure 10 This is a schematic diagram illustrating the effect of the hair growth lotion of the present invention on the morphology and number of hair follicles in the hair-removed area of ​​mice. Detailed Implementation

[0033] The embodiments of the present invention will now be clearly and completely described in conjunction with the accompanying drawings. Obviously, those skilled in the art will understand that the following embodiments are for illustrative purposes only and should not be considered as limiting the scope of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

[0034] Unless otherwise specified in the examples, the conditions shall be performed in accordance with conventional conditions or the conditions recommended by the manufacturer. If the manufacturer of the reagents or instruments used is not specified, they shall be conventional products that can be purchased commercially.

[0035] Example 1: The traditional Chinese medicine composition includes: 2.4g of Rehmannia glutinosa (processed), 2.4g of Ligustrum lucidum (processed with wine), 2.4g of Polygonum multiflorum (processed), 2.4g of Cuscuta chinensis, 2.4g of Polygonatum sibiricum (processed), 0.9g of Paeonia lactiflora, 0.9g of Prunus persica, 0.9g of Carthamus tinctorius, 0.6g of Notopterygium incisum, 0.6g of Ligusticum chuanxiong, and 0.6g of Chaenomeles speciosa.

[0036] The traditional Chinese medicine preparation includes: (a) an ethanol extract of traditional Chinese medicine, 1000-1100ml; prepared Rehmannia glutinosa 2.4g, Ligustrum lucidum 2.4g, Polygonum multiflorum 2.4g, Cuscuta chinensis 2.4g, Polygonatum sibiricum 2.4g, Paeonia lactiflora 0.9g, Prunus persica 0.9g, Carthamus tinctorius 0.9g, Notopterygium incisum 0.6g, Ligusticum chuanxiong 0.6g, and Chaenomeles speciosa 0.6g as raw materials, which are extracted by ethanol soaking; (b) Glycerin: 71ml; (c) Ethanol: 266-294 ml.

[0037] The preparation method of the traditional Chinese medicine preparation for hair growth and nourishment in this embodiment includes the following steps: (1) Take 2.4g of Rehmannia glutinosa, 2.4g of Ligustrum lucidum, 2.4g of Polygonum multiflorum, 2.4g of Cuscuta chinensis, 2.4g of Polygonatum sibiricum, 0.9g of Paeonia lactiflora, 0.9g of Prunus persica, 0.9g of Carthamus tinctorius, 0.6g of Notopterygium incisum, 0.6g of Ligusticum chuanxiong, and 0.6g of Chaenomeles speciosa. Clean and remove impurities, crush the herbs, and make sure that all the coarse powder passes through a 24-mesh sieve, and that the proportion passing through a 65-mesh sieve is not less than 60%; (2) Put the coarse powder obtained in step (1) into a mixing bucket, add 1350ml of 75% ethanol solution, so that the ethanol liquid completely submerges the coarse powder of the herbs and is appropriately higher than its surface, and stir slowly in the same direction to ensure that the herbs and ethanol are fully mixed. Seal the container lid and place it in a room temperature environment of 20-25℃ and away from light for 96 hours. During the soaking period, it is necessary to stir once every 12 hours. (3) Stir slowly in the same direction for more than 5 minutes while stirring; (4) Filter the mixture after soaking in step (2) for the first time. Use six layers of medical gauze for filtration, and slowly pour the supernatant onto the gauze for filtration. Wrap the remaining residue with gauze and squeeze it appropriately to extract as much residual liquid as possible. Combine the filtrates. The amount of filtrate collected this time is expected to be about 1080-1148 ml; (5) Let the filtrate obtained in step (3) stand at room temperature (20-25℃) and away from light for 48 hours for a second filtration. Slowly pour out the supernatant and filter it using a fusion funnel (G1). A small amount of sediment at the bottom of the container can be discarded. The amount of clarified filtrate collected this time is expected to be about 1000-1100ml; (5) Add 71ml of glycerin to the secondary filtrate obtained in step (4) and stir evenly; (6) Add 75% ethanol solution to the solution in step (5) and stir continuously until the total volume of the medicine solution reaches exactly 1350ml, thus obtaining the hair growth and hair nourishing Chinese medicine liniment.

[0038] Example 2: The traditional Chinese medicine composition includes: 1.8g of Rehmannia glutinosa (processed), 1.8g of Ligustrum lucidum (processed with wine), 1.8g of Polygonum multiflorum (processed), 1.8g of Cuscuta chinensis, 1.8g of Polygonatum sibiricum (processed), 0.6g of Paeonia lactiflora, 0.6g of Prunus persica, 0.6g of Carthamus tinctorius, 0.36g of Notopterygium incisum, 0.36g of Ligusticum chuanxiong, and 0.36g of Chaenomeles speciosa.

[0039] The traditional Chinese medicine preparation includes: (a) an ethanol extract of traditional Chinese medicine, 750-800ml; prepared Rehmannia glutinosa 1.8g, Ligustrum lucidum 1.8g, prepared Polygonum multiflorum 1.8g, Cuscuta chinensis 1.8g, Polygonatum sibiricum 1.8g, Paeonia lactiflora 0.6g, Prunus persica 0.6g, Carthamus tinctorius 0.6g, Notopterygium incisum 0.36g, Ligusticum chuanxiong 0.36g, and Chaenomeles speciosa 0.36g, which are extracted by ethanol soaking. (b) Glycerin: 50ml; (c) Ethanol: 150-200ml.

[0040] The preparation method of the traditional Chinese medicine preparation for hair growth and nourishment in this embodiment includes the following steps: (1) Prepared Rehmannia glutinosa 1.8g, Ligustrum lucidum 1.8g, Polygonum multiflorum 1.8g, Cuscuta chinensis 1.8g, Polygonatum sibiricum 1.8g, Paeonia lactiflora 0.6g, Prunus persica 0.6g, Carthamus tinctorius 0.6g, Notopterygium incisum 0.36g, Ligusticum chuanxiong 0.36g, Chaenomeles speciosa 0.36g, cleaned to remove impurities, pulverized, so that all the coarse powder of the medicinal materials passes through a 24-mesh sieve, and the proportion passing through a 65-mesh sieve is not less than 60%; (2) Put the coarse powder obtained in step (1) into a mixing bucket, add 1000ml of 75% ethanol solution, so that the ethanol liquid completely submerges the coarse powder of the medicinal materials and appropriately raises it above its surface, and slowly stir in the same direction to ensure that the medicinal materials and ethanol are fully mixed. Seal the container lid and place it in a room temperature environment of 20-25℃, away from light, for 96 hours. During the soaking period, it is necessary to stir once every 12 hours. (3) Stir slowly in the same direction for more than 5 minutes while stirring; (4) Filter the mixture after soaking in step (2) for the first time. Use six layers of medical gauze for filtration, and slowly pour the supernatant onto the gauze for filtration. Wrap the remaining residue with gauze and squeeze it appropriately to extract as much residual liquid as possible. Combine the filtrates. The amount of filtrate collected this time is expected to be about 800-850ml; (5) Let the filtrate obtained in step (3) stand at room temperature (20-25℃) and away from light for 48 hours for a second filtration. Slowly pour out the supernatant and filter it using a fusion funnel (G1). A small amount of sediment at the bottom of the container can be discarded. The amount of clarified filtrate collected this time is expected to be about 750-800ml; (5) Add 50ml of glycerin to the secondary filtrate obtained in step (4) and stir evenly; (6) Add 75% ethanol solution to the solution in step (5) and stir continuously until the total volume of the medicine solution reaches exactly 1000ml, thus obtaining the hair growth and hair nourishing Chinese medicine liniment.

[0041] Example 3: The herbal composition consists of: 1.5g Rehmannia glutinosa (processed), 1.5g Ligustrum lucidum (processed with wine), 1.5g Polygonum multiflorum (processed), 1.5g Cuscuta chinensis, 1.5g Polygonatum sibiricum (processed), 0.3g Paeonia lactiflora, 0.3g Prunus persica, 0.3g Carthamus tinctorius, 0.2g Notopterygium incisum, 0.2g Ligusticum chuanxiong, and 0.2g Chaenomeles speciosa.

[0042] The traditional Chinese medicine preparations include: (a) an ethanol extract of traditional Chinese medicine, 625-667 ml; obtained by immersion in ethanol and extracting the following raw materials: 1.5 g of Rehmannia glutinosa (processed), 1.5 g of Ligustrum lucidum (processed), 1.5 g of Polygonum multiflorum (processed), 1.5 g of Cuscuta chinensis, 1.5 g of Polygonatum sibiricum, 0.3 g of Paeonia lactiflora, 0.3 g of Prunus persica, 0.3 g of Carthamus tinctorius, 0.2 g of Notopterygium incisum, 0.2 g of Ligusticum chuanxiong, and 0.2 g of Chaenomeles speciosa. (b) Glycerin: 43ml; (c) Ethanol: 123-165ml.

[0043] The preparation method of the traditional Chinese medicine preparation for hair growth and nourishment in this embodiment includes the following steps: (1) 1.5g of Rehmannia glutinosa, 1.5g of Ligustrum lucidum, 1.5g of Polygonum multiflorum, 1.5g of Cuscuta chinensis, 1.5g of Polygonatum sibiricum, 0.3g of Paeonia lactiflora, 0.3g of Prunus persica, 0.3g of Carthamus tinctorius, 0.2g of Notopterygium incisum, 0.2g of Ligusticum chuanxiong, and 0.2g of Chaenomeles speciosa are cleaned to remove impurities, pulverized, and all the coarse powder of the medicinal materials passes through a 24-mesh sieve, and the proportion passing through a 65-mesh sieve is not less than 60%; (2) The coarse powder obtained in step (1) is put into a mixing bucket, and 833ml of 75% ethanol solution is added so that the ethanol liquid completely submerges the coarse powder of the medicinal materials and is appropriately higher than its surface. Stir slowly in the same direction to ensure that the medicinal materials and ethanol are fully mixed. Seal the container lid and place it in a room temperature environment of 20-25℃ and away from light for 96 hours. During the soaking period, it is necessary to stir once every 12 hours. (3) Stir slowly in the same direction for more than 5 minutes while stirring; (4) Filter the mixture after soaking in step (2) for the first time. Use six layers of medical gauze for filtration, and slowly pour the supernatant onto the gauze for filtration. Wrap the remaining residue with gauze and squeeze it appropriately to extract as much residual liquid as possible. Combine the filtrates. The amount of filtrate collected this time is expected to be about 666-708 ml; (5) Let the filtrate obtained in step (3) stand at room temperature (20-25℃) and away from light for 48 hours for a second filtration. Slowly pour out the supernatant and filter it using a fusion funnel (G1). A small amount of sediment at the bottom of the container can be discarded. The amount of clarified filtrate collected this time is expected to be about 625-666ml; (5) Add 43ml of glycerin to the secondary filtrate obtained in step (4) and stir evenly; (6) Add 75% ethanol solution to the solution in step (5) and stir continuously until the total volume of the medicine solution reaches exactly 833ml, thus obtaining the hair growth and hair nourishing Chinese medicine liniment.

[0044] Example 4: The traditional Chinese medicine preparation includes: 500ml of the hair growth liniment prepared in Example 2, 500ml of purified water, 15g of carbomer-940 powder, and 5.2g of triethanolamine; The preparation method of the herbal gel for hair growth and nourishment in this embodiment includes the following steps: (1) Take 500ml of the hair growth liniment prepared in Example 2, 500ml of purified water, 15g of carbomer-940 powder, and 5.2g of triethanolamine; (2) Add purified water to the mixing tank and stir at low speed to form a gentle and stable vortex on the water surface. Sprinkle 15g of carbomer-940 powder evenly and slowly on the edge of the vortex in an equal increment method, so that the water flow naturally carries the powder in and disperses it in the water to avoid clumping; after adding the carbomer powder, continue stirring for 20 to 30 minutes and then stop stirring. Seal the container and let it stand at room temperature for 24 hours to obtain the gel matrix; (3) Add 500ml of hair growth liniment prepared in Example 2 to the gel matrix, stir, and gradually increase the stirring speed to medium speed so that the medicine and the gel matrix are mixed evenly; while stirring, add triethanolamine dropwise, and take a sample to measure the pH value according to the actual situation until the pH value reaches between 6.5 and 7.5, then stop adding. At this time, the amount of triethanolamine used is about 5.2g; then the hair growth gel can be obtained.

[0045] 1. Clinical research 1.1 Research Objective: To observe the application effect of topical hair growth gel on patients with hair loss. 1.2 Clinical Cases: Twenty male and female patients with hair loss (10 males and 10 females) aged 23–44 years who visited the Hair Treatment Center of the Affiliated Hospital of Tianjin Academy of Traditional Chinese Medicine between August 2023 and November 2025 were included. All patients met the clinical diagnostic criteria for hair loss and had no history of drug allergies or contraindications to medication such as severe liver or kidney dysfunction.

[0046] 1.3. Method of use: Apply the Chinese herbal gel preparation obtained in Example 4 above to the top area of ​​the hairline on both sides of the patient. Apply the medicine externally (equivalent to 1ml), spread it evenly and massage it in thoroughly. Apply once in the morning and once in the evening, and the total daily dosage shall not exceed 2ml.

[0047] 1.4 Evaluation of Application Effect: After 16 weeks of medication, images of the target area were collected using a scalp trichoscopy system. The two core indicators of hair quantity and hair density were quantitatively evaluated through a professional image analysis system to objectively reflect the treatment effect.

[0048] like Figures 1 to 4As shown, four groups of hair loss patients were randomly selected, and their scalp and hair microscopic images were compared before and after applying topical hair growth and nourishing Chinese herbal preparations. The lens area was 0.903 square centimeters. Different colors in the images represent different types of hair, such as blue for terminal hair, yellow for vellus hair, and green for intermediate hair. This makes it easy to distinguish hair thickness and determine whether hair follicles have degenerated. Circles and markers represent hair follicle units in the images. The number of dots in each circle indicates the number of hairs contained in that follicle unit. Different colored circles were used according to the number of hairs in a unit follicle. For example, a dark blue circle represents 1 hair, a green circle represents 2 hairs, a light blue circle represents 3 hairs, a red circle represents 4 hairs, a magenta circle represents 5 hairs, and a yellow circle represents 6 hairs. These images are used for further analysis and calculation of hair follicle density, the number of hairs in a single follicle, and overall hair growth.

[0049] A comparative analysis of scalp and hair microscopic images of patients with hair loss before and after application of topical Chinese herbal preparations for hair growth and nourishment in clinical studies yielded a bar graph analysis. Figure 5 .like Figure 5 As shown, after 16-20 weeks of continuous use of the hair growth lotion, all hair-related indicators showed significant improvement compared to before treatment. The results indicate that this traditional Chinese medicine preparation for hair growth and nourishment can effectively increase hair quantity, density, and follicular unit indicators, especially by specifically promoting vellus hair growth, thus improving hair loss symptoms. Furthermore, the efficacy demonstrates statistical reliability and clinical applicability, providing an effective treatment option for hair loss patients. Details are as follows: (1) The number and density of hair in patients with hair loss are significantly increased. The average number of hairs increased from (113.60±46.96) hairs / 0.903 cm² before treatment to (162.05±46.73) hairs / 0.903 cm², and the average hair density increased from (147.90±51.97) hairs / cm² before treatment to (179.41±51.74) hairs / cm². The statistical differences between the two indicators were significant (t-values ​​were 6.870 and 6.880, respectively, both P<0.0001) (Table 1). This result indicates that the hair growth lotion can effectively promote the hair production capacity of hair follicles, not only increasing the total number of hairs per unit area but also improving the density of hair distribution, thus improving the core clinical problem of "sparse hair" in patients with hair loss. Furthermore, the statistical reliability of the efficacy is high, excluding the interference of accidental factors. Table 1. Effects of hair growth gel treatment on hair quantity and density in patients with hair loss. index Before treatment After treatment Number of hairs (roots) 133.6±46.96 162.05±46.73 6.870 ＜0.0001 <![CDATA[Hair density (cm 2 )]]> 147.90±51.97 179.41±51.74 6.880 ＜0.0001 (2) The amount of vellus hair in patients with hair loss has significantly improved. After treatment, the average number of terminal hairs increased from (50.45±20.17) to (66.10±22.51), a statistically significant difference (t=2.528, P=0.0205<0.05). This indicates that the hair growth gel can promote the transformation of hair follicles to a more mature growth stage, helping the bald area to restore normal hair structure. However, although the average number of vellus hairs increased before and after treatment (before treatment: 41.15±38.92; after treatment: 47.40±46.40), it was not statistically significant (t=0.789, P=0.4396>0.05) (Table 2). The results show that this hair growth lotion can significantly increase the number of terminal hairs in the bald area, but it did not produce a clinically significant improvement in the growth of vellus hair. This may be because hair growth gels have the ability to "selectively act on the hair follicle growth phase," tending to activate hair follicles in the resting or regression phase to transform into the growth phase and promote their development into terminal hair.

[0050] Table 2. Effects of hair growth gel treatment on the amount of terminal hair and vellus hair in patients with hair loss. index Before treatment After treatment Number of terminal hairs (hairs) 50.45±20.17 66.10±22.51 2.528 0.0205 Number of downy hairs (roots) 41.15±38.92 47.40±46.40 0.789 0.4396 (3) The number and density of hair follicles in patients with hair loss are significantly increased. After treatment, the average number of hair follicle units increased from (80.6±20.45) to (93.5±20.25); the average hair follicle density increased from (89.22±22.63) units / cm² to (103.51±22.42) units / cm². Statistical analysis showed that the differences in both indicators before and after treatment were statistically significant (t values ​​were 7.284 and 7.288, respectively, both P<0.001) (Table 3). This indicates that the hair growth gel not only promotes hair production from existing hair follicles, but may also increase the number and density of functional hair follicle units by improving the hair follicle microenvironment and activating dormant hair follicles, providing a "structural basis" for long-term hair growth. Compared to simply increasing the number of hairs in the short term, the improvement in hair follicle unit-related indicators better reflects the intervention value of the hair growth gel on the pathological state of hair loss, helps reduce the risk of hair loss recurrence, and brings patients a more lasting and stable treatment effect.

[0051] Table 3. Effects of hair growth gel treatment on the number and density of hair follicles in patients with hair loss. index Before treatment After treatment Number of hair follicle units 80.6±20.45 93.5±20.25 7.284 ＜0.0001 <![CDATA[Hair follicle density (cm 2 )]]> 89.22±22.63 103.51±22.42 7.288 ＜0.0001 2. In vitro culture experiment of immortalized human follicular dermal papillary cells (HFDPC) 2.1 Research Objective: To evaluate the optimal concentration of serum containing the hair growth liniment for optimal effect; and to verify the proliferative effect of serum containing the hair growth liniment on HFDPC.

[0052] 2.2 Research Methods: SD rats were randomly divided into a blank control group and a serum group containing the herbal preparation for hair growth and nourishment, with a human-to-rat equivalent dose ratio of 6.17:1. The herbal liniment prepared in Example 2 was administered by gavage for 3 days, and the blank control group was administered physiological saline by gavage for 3 days. Blood was collected from the abdominal aorta of the rats to prepare serum containing the herbal preparation for hair growth and nourishment and blank serum. HFDPCs were cultured in DMEM medium at 37℃ in a 5% CO2 incubator until the 7th generation. HFDPCs in the logarithmic growth phase were collected, and the cell density was adjusted to 5 × 10⁻⁶ cells / mL. 4 Cells were seeded at 100 μL / well in 96-well plates. After 24 hours of cell adhesion, the cells were divided into two groups: control group (40% blank serum) and experimental groups (20%, 25%, 30%, 35%, and 40% drug-containing serum, with blank serum used to supplement any groups with less than 40%). Each group had 5 replicates. After incubation at 37°C and 5% CO2 for 24 hours, 10 μL / well of CCK8 working solution was added to each well. After incubation for 2 hours, the absorbance (OD) of each group at 450 nm was measured using a microplate reader. The proliferation rate (%) was calculated as: (OD value of control group - OD value of drug-containing serum group) × 100%. Analysis of variance (ANOVA) was used to compare the differences between groups. P < 0.05 was considered statistically significant. PCR was used to measure the expression of the cell proliferation marker cyclin D1 gene to verify the proliferative effect of the drug-containing serum on HFDPCs.

[0053] 2.3 Experimental Results like Figure 6 As shown, compared with the control group (containing 40% blank serum), serums containing the hair growth and nourishing traditional Chinese medicine preparation at concentrations of 20%, 25%, 30%, 35%, and 40% all exhibited a promoting effect on HFDPC proliferation, and the promoting effect showed a concentration-dependent increasing trend. Cell proliferation activity was detected by the CCK-8 assay after 24 hours. The results showed that the cell viability (OD value) of each serum-containing group was significantly higher than that of the control group (P<0.05). Among them, the 25% concentration of serum containing the hair growth liniment showed the best effect, while the 30%, 35%, and 40% concentration groups, although still having a promoting effect, showed a weakened effect compared to the 25% concentration group, exhibiting a trend of first increasing and then decreasing. This may be related to the non-specific effects of certain components in high-concentration serum on cells. These results indicate that serum containing the hair growth liniment at a concentration of 25% can effectively promote HFDPC proliferation.

[0054] Cyclin D1, a core protein in cell cycle regulation, plays a decisive role in key life activities such as cell proliferation and differentiation. To investigate the effect of serum containing a hair growth product on the cell cycle of hair follicles, we further examined the expression of the Cyclin D1 gene. Figure 7As shown, compared with the control group, the Cyclin D1 gene expression was significantly increased in the 25% hair growth liniment-containing serum treatment group (*P<0.05). This result corresponds to the optimal promoting effect of the 25% concentration of liniment-containing serum on the proliferation of human follicular dermal papilla cells (HFDPC) in the cell proliferation experiment, suggesting that the 25% hair growth liniment-containing serum may enhance cell proliferation capacity by upregulating Cyclin D1 gene expression and activating cell cycle processes. This provides a molecular-level mechanistic clue to its role in promoting hair growth and further corroborates the potential value of appropriate concentrations of liniment-containing serum in regulating the hair follicle cell cycle and promoting hair follicle development.

[0055] In summary, the hair growth lotion containing serum at a concentration of 25% significantly promoted the proliferation of human follicular dermal papillary cells (HFDPC), upregulated Cyclin D1 gene expression, and activated cell cycle progression.

[0056] 3. Animal experimental studies 3.1 Research Objective: To establish an AGA (androgenetic alopecia) model in mice by applying testosterone to the back of the body, to observe the preliminary therapeutic effect of the topical application of the traditional Chinese medicine preparation prepared in Example 2 on the androgenetic alopecia model mice, and to compare its effect with that of minoxidil tincture, which is widely used in the industry to treat androgenetic alopecia, so as to provide experimental evidence for the auxiliary hair care effect of topical application of traditional Chinese medicine preparations in preventing hair loss and promoting hair growth.

[0057] 3.2 Research Methods: Male C57BL / 6 mice were used as the animal model. Forty-eight male C57BL / 6 mice, 6-7 weeks old and weighing (20±2) g, were used. The fur on the backs of the mice was shaved short using a pet shaver, and depilatory cream was applied to remove any remaining hair. Then, 0.2 ml of 0.2% diluted testosterone solution was applied to the shaved area once daily for 14 consecutive days. Successful AGA (androgenetic alopecia) modeling was considered achieved when the backs of the mice were smooth and pink and hair no longer grew back. The mice were then divided into a model group, a positive drug group, and experimental groups (low, medium, and high doses of the traditional Chinese medicine preparation obtained in Example 2 above), with eight mice in each group. The model group received no medication, while the positive drug group received 0.2 ml of 5% minoxidil solution once daily, and the experimental groups (low, medium, and high doses of the hair growth liniment) received 0.2 ml once daily for two weeks.

[0058] 3.3 Research Results: like Figure 8As shown, no obvious redness, swelling, erosion, or ulceration was observed in the skin of the mice treated with the medication in each group. Compared with the model group, the discoloration time of the skin in the hairless area on the back of the mice in other groups was shortened to varying degrees, and the area of ​​new hair growth was increased to varying degrees. Among them, the positive drug group and the high-dose hair growth liniment group had the most significant hair growth promoting effect on mice, suggesting that the high-dose hair growth liniment group has a significant hair growth promoting effect.

[0059] After treatment with the hair removal cream, the mouse skin turned pink, indicating that the hair follicles had entered the resting phase; in the early growth phase, the skin is gray / black. Seven days after hair removal, the back skin of the positive control group and the medium- and high-dose groups showed signs of darkening, indicating that melanin was being produced and gradually accumulating in the dermis, while the low-dose group and the model group showed virtually no change. Two weeks after hair removal, the high-dose hair regrowth lotion group and the positive control group showed obvious patchy hair growth, with skin color almost completely restored, while the low- and medium-dose hair regrowth lotion groups mainly showed grayish back skin with scattered punctate hair growth.

[0060] like Figure 9 As shown, 14 days after administration, dermoscopy revealed sparse new hair growth in the hairless areas on the backs of mice. Mice in the positive drug group and the high-dose hair regrowth lotion group showed significant new hair growth. Mice without hair regrowth were excluded. The length of new hair and the proportion of melanin-containing hair follicles in the hairless areas of the mice were measured, and the results are shown in Table 4. Regarding hair length, compared with the model group, the length of new hair growth in all treatment groups was significantly increased, with a statistically significant difference between the positive drug group and the model group. P <0.01); similarly, compared with the model group, the ratio of melanin-containing hair follicles to the total number of hair follicles was significantly increased in the positive drug group and the high-dose hair growth lotion group ( P <0.05, P <0.01). This suggests that high doses of the hair growth lotion improved hair growth density in an AGA mouse model.

[0061] Table 4. Effects of different doses of hair growth lotion on hair length and density in AGA mice ( ± s , n =6) Grouping Newborn hair length (cm) The proportion of melanin-rich hair follicles Blank group <![CDATA[0.39±0.02 ** ]]> <![CDATA[0.87±0.06 ** ]]> Model group 0.22±0.03 0.53±0.09 Positive drug group <![CDATA[0.36±0.02 ** ]]> <![CDATA[0.75±0.11 * ]]> low-dose group 0.27±0.01 0.70±0.06 medium dose group 0.29±0.00 0.75±0.04 High-dose group 0.33±0.03 <![CDATA[0.81±0.07 ** ]]> Note: P Compared with the model group, * P< 0.05 ** P <0.01 like Figure 10As shown, red circles represent vellus hair and green circles represent terminal hair. After 14 days of drug administration, the histological examination of the skin tissue on the back of mice using HE staining sections showed that in the control group and each drug administration group, most hair follicles showed enlarged hair bulbs, melanin production, and growth into the dermis, indicating that they had entered the growth phase. In contrast, in the model group, most hair follicles showed reduced melanin, and some hair follicles showed abnormal sebaceous glands.

[0062] Compared with the model group, the number of vellus hairs was significantly reduced in the positive drug group and the high-dose group. P <0.01), the medium-dose group showed a decrease in vellus hair count, which was statistically significant ( P <0.05). Compared with the model group, the vellus hair / terminal hair ratio was significantly reduced in the positive drug group and the high-dose group ( P <0.01 (Table 5). This suggests that the traditional Chinese medicine preparation for hair growth and nourishment improved the miniaturization of AGA hair follicles.

[0063] Table 5. Effects of different doses of traditional Chinese medicine preparations for hair growth and nourishment on the number of hair follicles in vellus hair and terminal hair in AGA mice ( ± s , n =6) Note: P Compared with the model group, * P< 0.05 ** P< 0.01 The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for promoting hair growth and nourishing hair, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: Prepared Rehmannia Root 15-24 parts, Wine-processed Ligustrum Lucidum 15-24 parts, Processed Polygonum Multiflorum 15-24 parts, Cuscuta Seed 15-24 parts, Refined Polygonatum Rhizome 15-24 parts, White Peony Root 3-9 parts, Peach Kernel 3-9 parts, Safflower 3-9 parts, Notopterygium Root 2-6 parts, Ligusticum Rhizome 2-6 parts, Papaya 2-6 parts.

2. The traditional Chinese medicine composition for hair growth and nourishment according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: Prepared Rehmannia Root 18 parts, Wine-processed Ligustrum Lucidum 18 parts, Processed Polygonum Multiflorum 18 parts, Cuscuta Seed 18 parts, Refined Polygonatum Rhizome 18 parts, White Peony Root 6 parts, Peach Kernel 6 parts, Safflower 6 parts, Notopterygium Root 3.6 parts, Ligusticum Rhizome 3.6 parts, Papaya 3.6 parts.

3. The use of the traditional Chinese medicine composition for hair growth and nourishment according to any one of claims 1-2 in the preparation of a pharmaceutical preparation for improving hair loss symptoms.

4. A traditional Chinese medicine preparation for promoting hair growth and nourishing hair, characterized in that, The traditional Chinese medicine preparation includes the traditional Chinese medicine composition according to any one of claims 1-2.

5. The traditional Chinese medicine preparation for hair growth and nourishment according to claim 4, characterized in that, The dosage form of the traditional Chinese medicine preparation is either a liniment or a gel.

6. A method for preparing a traditional Chinese medicine preparation for hair growth and nourishment as described in claim 5, characterized in that, Includes the following steps: (1) Preparation of ethanol extract of traditional Chinese medicine: S1. Weigh the raw materials; S2. Pre-treat the raw materials; S3. Impregnation and filtration: Transfer the pretreated raw material obtained in step (S2) to a mixing tank, add a certain amount of ethanol solution to the mixing tank to completely soak the raw material, seal and impregnate it under certain conditions for 2-6 days, let it stand and filter it 1-3 times to obtain the Chinese herbal ethanol extract. (2) Preparation: Add a certain amount of glycerol to the ethanol extract of Chinese medicine obtained in step (1), stir until the glycerol and ethanol extract are mixed evenly to obtain the pre-prepared product; (3) Volume adjustment: Add ethanol to the pre-prepared solution obtained in step (2), stir again until the total volume of the liquid reaches the required volume, and obtain the traditional Chinese medicine preparation for hair growth and nourishment.

7. The method for preparing a traditional Chinese medicine preparation for hair growth and nourishment according to claim 6, characterized in that: The preprocessing described in step (S2) includes the following steps: a. Cleaning: Removing impurities from the raw materials to obtain clean medicinal materials; b. Crushing: The cleaned medicinal materials obtained in step a are crushed to obtain coarse powder with a particle size range of all passing through a 24-mesh sieve and at least 60% passing through a 65-mesh sieve.

8. The method for preparing a traditional Chinese medicine preparation for hair growth and nourishment according to claim 6, characterized in that: The impregnation and filtration described in step S3 specifically include: (1) Impregnation: Transfer the pretreated raw materials obtained in step (S2) to the mixing tank, add a certain amount of 70%-80% ethanol solution to the mixing tank, so that the ethanol liquid completely submerges the coarse powder of the medicinal material and is appropriately higher than the surface of the coarse powder, stir to ensure that the medicinal material and ethanol are fully mixed, seal the container lid, and place it in a room temperature environment of 20-25℃ and in the dark for 84-108 hours. During the impregnation period, it is necessary to stir once every 12 hours, and stir slowly in the same direction for 5-10 minutes each time. (2) Filtration: Filter the drug solution that has been soaked in step (1) using six layers of medical gauze, take the filtrate, and squeeze the drug residue to obtain a secondary filtrate. Mix the two filtrates to obtain a mixed filtrate. (3) Standing: Let the mixed filtrate obtained in step (2) stand at room temperature (20-25℃) in the dark for 36-60 hours; (4) Secondary filtration: The mixed filtrate that has been allowed to stand in step (3) is filtered a second time, the supernatant is taken and the precipitate is discarded; the supernatant is filtered with a fusion funnel (G1) to obtain the ethanol extract of traditional Chinese medicine.

9. The use of a traditional Chinese medicine composition as described in any one of claims 1-2 or a traditional Chinese medicine preparation as described in any one of claims 4-8 in the preparation of a medicament for improving hair production in patients' hair follicles, increasing functional hair follicle units, and reducing the risk of hair loss recurrence.

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