Traditional Chinese medicine external preparation for treating alopecia
By using traditional Chinese medicine formulations and multiple dosage forms, the limitations of Western medicine in treating hair loss and the problem of insufficient penetration of traditional Chinese medicine have been solved, achieving efficient hair growth and low recurrence rate, and adapting to the treatment needs of different types of hair loss.
Patent Information
- Application Number
- CN202511535883.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-10-27
- Publication Date
- 2025-12-19
AI Technical Summary
Existing Western medicine treatments for hair loss have limitations. For example, minoxidil can easily cause scalp irritation and hirsutism, finasteride may interfere with sexual function, and traditional Chinese medicine hair growth products have sticky or insufficiently penetrating formulations, making it difficult to balance efficacy and user experience.
The formula uses a combination of traditional Chinese medicines, including Polygonum multiflorum, Platycladus orientalis leaves, Salvia miltiorrhiza, Angelica sinensis, Ligusticum chuanxiong, Eclipta prostrata, Ligustrum lucidum, Clematis chinensis, ginger, borneol, and licorice. It combines three dosage forms: tincture, gel, and spray. It utilizes ethanol extraction, water-alcohol dual extraction, and azone transdermal penetration enhancer to achieve precise drug delivery and efficient penetration.
It significantly increases hair density and diameter, reduces the relapse rate after discontinuation of medication, adapts to different stages of hair loss and patient preferences, and provides a treatment effect that addresses both the symptoms and the root cause.
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Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of traditional Chinese medicine preparation, in particular to a traditional Chinese medicine external preparation for treating alopecia. BACKGROUND
[0002] Alopecia is a common hair disease, and modern medicine mainly uses drugs such as minoxidil and finasteride. Such western medicines have obvious limitations: minoxidil can easily cause scalp irritation, hirsutism and re-alopecia after drug withdrawal; finasteride can interfere with sexual function and is prohibited for men of childbearing age. The existing traditional Chinese medicine hair-growing products have problems such as complex prescription, unclear mechanism, sticky or insufficient penetration of dosage form, and are difficult to balance efficacy and use experience.
[0003] According to traditional Chinese medicine theory, alopecia is closely related to liver and kidney deficiency, blood stasis and damp-heat upward transmission. Traditional external preparations often ignore modern transdermal technology and active ingredient extraction process, resulting in low bioavailability of effective components. There is an urgent need in the current market for a traditional Chinese medicine external preparation based on classical theory, appropriate compatibility, and dosage form adapted to the physiological characteristics of the scalp to achieve both the symptoms and the root cause. SUMMARY
[0004] The purpose of this section is to summarize some aspects of the embodiments of the present application and briefly introduce some preferred embodiments. Some simplifications or omissions may be made in this section and the abstract and title of the specification to avoid obscuring the purpose of this section, the abstract and the title. Such simplifications or omissions cannot be used to limit the scope of the present application.
[0005] In view of the problems in the prior art, the present application is proposed.
[0006] Therefore, the purpose of the present application is to overcome the deficiencies in the prior art and provide a traditional Chinese medicine external preparation for treating alopecia.
[0007] To solve the above technical problems, the present application provides the following technical scheme: a traditional Chinese medicine external preparation for treating alopecia, which is composed of the following raw materials in parts by weight: 15-30 parts of radix polygoni multiflori, 10-25 parts of cypress leaves, 10-20 parts of salvia miltiorrhiza, 8-15 parts of angelica sinensis, 5-12 parts of ligusticum wallichii, 8-15 parts of eclipta prostrata, 8-15 parts of ligustrum lucidum, 5-10 parts of rubia akane, 3-8 parts of ginger or 0.1-0.5 parts of ginger volatile oil, 0.5-2 parts of borneol, and 3-8 parts of licorice.
[0008] As a preferred scheme of the traditional Chinese medicine external preparation for treating alopecia, the raw materials are proportioned as follows: 25 parts of radix polygoni multiflori, 20 parts of cypress leaves, 15 parts of salvia miltiorrhiza, 12 parts of angelica sinensis, 10 parts of ligusticum wallichii, 12 parts of eclipta prostrata, 12 parts of ligustrum lucidum, 8 parts of rubia akane, 5 parts of ginger or 0.3 parts of ginger volatile oil, 1 part of borneol, and 5 parts of licorice.
[0009] As a preferred scheme of the external preparation of traditional Chinese medicine for treating alopecia, the preparation form is selected from tincture, gel, and spray.
[0010] As a preferred scheme of the external preparation of traditional Chinese medicine for treating alopecia, when the preparation is tincture, the preparation includes: a) after the raw materials are crushed, 60-75% ethanol is used for extraction for 7-14 days (the ratio of material to liquid is 1:5-1:8); b) after filtration, ginger juice / volatile oil and ice flakes ethanol solution are added; c) the volume is adjusted to contain 1.0-1.5 g of crude drug per milliliter.
[0011] As a preferred scheme of the external preparation of traditional Chinese medicine for treating alopecia, when the preparation is gel, the preparation includes: a) the raw materials are decocted and concentrated to 1.10-1.20 g / ml of clear extract; b) alcohol precipitation is performed to contain 60-70% alcohol, and the supernatant is concentrated; c) after mixing with a carbomer base, the pH is adjusted to 6.0-7.0; d) ginger components, ice flakes, and a humectant are added.
[0012] As a preferred scheme of the external preparation of traditional Chinese medicine for treating alopecia, when the preparation is spray, the preparation includes: a) the raw materials are extracted with 60-75% ethanol; b) the filtrate is added with ice flakes and 0.5-2.0% azone; c) after adding water to adjust the volume, filtration and packaging are performed.
[0013] As a preferred scheme of the gel of the external preparation of traditional Chinese medicine for treating alopecia, the humectant is glycerol, and the amount is 3-8% of the total amount of the preparation.
[0014] As a preferred scheme of the tincture of the external preparation of traditional Chinese medicine for treating alopecia, the extraction temperature is 20-30°C, and the stirring is performed 1-2 times per day.
[0015] As a preferred scheme of the spray of the external preparation of traditional Chinese medicine for treating alopecia, azone, a transdermal enhancer, is contained, and the amount is 1.0%.
[0016] The spray of the external preparation of traditional Chinese medicine for treating alopecia is used for the preparation of a medicine for treating androgenetic alopecia or alopecia areata.
[0017] The present application has the following advantages: the preparation is based on the core principle of "tonifying kidney and essence as the monarch, promoting blood circulation and unblocking collaterals as the minister, and clearing heat and penetrating skin as the assistant"; Radix Polygoni Multiflori and Platycladi Leaves are used as the monarch herbs, which can synergistically activate hair follicle stem cells and inhibit the conversion of androgens; Salvia Miltiorrhiza, Angelica and Rhizoma Chuanxiong are used to improve microcirculation and reverse hair follicle atrophy; Eclipta Prostrata and Ligustri Lucidi Fructus are used to nourish yin and consolidate the body and block oxidative stress damage; Rhizoma Buergerae, Borneolum Syntheticum and Zingiber Officinale are used to form a penetrating drug system, which can break through the barrier of the stratum corneum and has the effects of anti-inflammation and oil control. The whole prescription forms a three-level network of "nourishing-blood-activating-penetrating drugs".
[0018] The tincture extracts liposoluble active substances with ethanol to directly reach the mamillary papilla; the gel uses water-alcohol double extraction combined with a biological adhesive matrix to prolong the action time; the spray realizes non-contact drug delivery by using a nitrogen ketone synergist. The three dosage forms cover different stages of the disease and patient preferences, and clinical verification shows that they can significantly improve hair density and diameter, and the recurrence rate after drug withdrawal is lower than that of chemical drugs. DETAILED DESCRIPTION
[0019] In order to make the above-mentioned objectives, features and advantages of the present application more apparent and easy to understand, the specific embodiments of the present application will be described in detail below with reference to the embodiments of the present application.
[0020] In the following description, many specific details are set forth in order to provide a thorough understanding of the present application. However, the present application can be practiced in other ways that are not identical to the description herein, and those skilled in the art can make similar extensions without departing from the scope of the present application, so the present application is not limited to the specific embodiments disclosed below.
[0021] Secondly, "one embodiment" or "embodiment" referred to herein means that a specific feature, structure or characteristic can be included in at least one implementation of the present application. "In one embodiment" appearing in different places in this specification does not mean the same embodiment, nor does it mean an embodiment that is separate or selectively excluded from other embodiments.
[0022] Embodiment 1 The present embodiment provides a traditional Chinese medicine external preparation for treating alopecia, specifically, a hair-growing tincture.
[0023] Formulation and process parameters
[0024] Preparation process: Medicine pretreatment: nine kinds of medicinal materials, Radix Polygoni Multiflori, Platycladi Leaves, Salvia Miltiorrhiza, Angelica, Rhizoma Chuanxiong, Eclipta Prostrata, Ligustri Lucidi Fructus, and Radix Glycyrrhizae, were ground into 20-mesh coarse powder, and then mixed uniformly and placed in a sealed extraction tank.
[0025] Preferred extraction operation: 900 ml of 65% ethanol solution (solid-liquid ratio 1:7 g / ml) was added, and extraction was carried out at 25±2℃ for 10 days in a sealed tank; Furthermore, mechanical stirring is performed twice daily for 10 minutes each time to promote diffusion balance; After extraction, the residue was coarsely filtered through four layers of gauze. The residue was washed twice with 200ml of 65% ethanol (stirring for 5 minutes each time), and the filtrates were combined to obtain the initial extract.
[0026] Post-processing and shaping: Juice fresh ginger and filter it, then add it to the initial extract; As one implementation method, borneol is pre-dissolved in 10 ml of 95% ethanol and then added to the system, and stirred for 30 minutes until completely dissolved; After standing for 48 hours, the supernatant was filtered through a 0.45μm microporous membrane. Add 65% ethanol to a final volume of 1000ml (containing 1.2g / ml of crude drug), and dispense into brown light-proof bottles.
[0027] Quality Inspection Standards Appearance: A clear, brownish-red liquid with a characteristic medicinal aroma and ginger-like pungent taste; pH value: 5.8-6.2 (measured by potentiometry at 25℃); Content determination: Quercetin ≥ 0.15 mg / ml and Tanshinone IIA ≥ 0.06 mg / ml were determined by HPLC. Stability: Accelerated test (40℃±2℃, RH75%±5%) for 6 months, active ingredient degradation rate <5%.
[0028] Example 2 This embodiment provides a topical Chinese medicine preparation for treating hair loss, specifically a hair growth gel.
[0029] Formula and key parameters
[0030] Preparation process: Water extraction and concentration stage: Specifically, weigh out 30 parts of Polygonum multiflorum, 18 parts of Platycladus orientalis leaves, and other ten medicinal materials (excluding volatile oil and borneol), add 10 times the amount of purified water and soak for 30 minutes; After bringing to a boil over high heat, reduce to a simmer and cook for 1.5 hours. Filter the liquid. Add 8 times the amount of water to the dregs and simmer again for 1 hour. Combine the filtrates. Concentrate under reduced pressure (60-70℃) to a clear extract with a relative density of 1.15 (60℃).
[0031] Alcohol precipitation purification stage: Cool the ointment to 25°C, and slowly add 95% ethanol while stirring until the alcohol content reaches 65%. After standing for 24 hours, the supernatant was collected to recover the ethanol until there was no alcohol odor, yielding a thick extract (yield 58% ± 3%).
[0032] Gelation stage: As a preferred embodiment, Carbopol 940 was dispersed in 400ml purified water, swelled overnight to form a transparent matrix; The thick extract was added into the matrix, and treated by homogenizer at 3000rpm for 5 minutes; Triethanolamine was added dropwise to adjust pH to 6.5, forming a gel matrix; Low temperature mixing: menthol (0.8g pre-dissolved in ethanol) and ginger volatile oil were added, and finally glycerol was added and water was added to 1000g, and homogenized to obtain.
[0033] Formulation characteristics: rheology: viscosity 8500-9500 mPa·s (Brookfield DV2T, 25℃); Transdermal performance: measured by Franz diffusion cell, the cumulative penetration amount of quercetin was 62.5±3.2μg / cm 2 ; Stability: no delamination and discoloration was observed after storage at 4-30℃ for 12 months.
[0034] Example 3 The present embodiment provides a traditional Chinese medicine external preparation for treating alopecia, specifically, a hair growth spray.
[0035] Formulation and process:
[0036] Preparation process: Extraction stage: Specifically, 20 parts of Radix Polygoni Multifidi and 25 parts of Cacumen Platycladi were crushed, and 70% ethanol was added according to the solid-liquid ratio of 1:6. Preferably, dynamic extraction was used: 25℃ for 7 days, with ultrasonic-assisted extraction (40kHz, 30 minutes per day) during the period; Filtering, squeezing the residue, and combining the filtrate to obtain about 650ml of ethanol extract.
[0037] Compounding and constant volume: Menthol 1.5 parts and azone 10ml were pre-mixed with 20ml 95% ethanol, and then added to the extract; As an embodiment, purified water was added to 1000ml, and stirred for 30 minutes; Sterilized by 0.22μm filter membrane and packaged in a quantitative spray bottle (0.10±0.02ml per spray).
[0038] Alternative process path: Further, to adapt to industrial production, percolation method can be used: after the medicinal materials are wetted, they are packed into a column, and 70% ethanol is percolated (flow rate 2ml / min), and 8 times the amount of percolate is collected and directly added to the transdermal component.
[0039] Quality evaluation Spray characteristics: spray angle 60°±5°, droplet size D50=52.3 μm (laser diffraction method); Content uniformity: continuous injection for 50 times, quercetin content RSD=1.8% (HPLC determination); Irritation evaluation: HET-CAM score 0.8, belonging to the non-irritating category.
[0040] In summary, the formulation constructs a three-dimensional treatment system of "kidney and essence as the foundation, blood circulation as the path, and transdermal targeting as the bridge".
[0041] The monarch drug level (Radix Polygoni Multifidi-Cacumen Platycladi): Radix Polygoni Multifidi nourishes the kidney and fills essence, directly targeting the core pathogenesis of "the kidney stores essence, and its splendor is in hair", providing a material basis for hair follicle regeneration; Cacumen Platycladi clears blood heat and dampness, addressing the symptoms of "blood heat and dryness". The combination of the two forms the cornerstone of "treatment of both the root and the branch".
[0042] The minister and assistant network: Salvia miltiorrhiza-Angelica sinensis-Szechuan lovage root forms the "iron triangle of blood circulation": tanshinone improves microcirculation around the hair follicle, angelica polysaccharide up-regulates VEGF to promote angiogenesis, and ligustilide inhibits platelet aggregation to reduce blood viscosity. The three work together to reverse the hair follicle atrophy caused by "blood stasis and obstruction of collaterals". Eclipta prostrata-Schisandra chinensis (Erzhi pill) targets the essence of "liver and kidney deficiency", and the iridoid glycoside removes oxidative damage to the hair follicle through the Nrf2 / ARE pathway. The "drug penetration engine" is composed of Rhizoma Bletillae-Borneol-Ginger: methyl salicylate softens the stratum corneum, borneol disrupts the arrangement of intercellular lipids, and gingerols activate the TRPV1 receptor to dilate capillaries, significantly improving drug bioavailability.
[0043] Further, the three dosage forms are not simply morphological differences, but precise designs based on the anatomical characteristics of the scalp and the pathological characteristics of hair loss: Tincture (lipid channel dominant type) is suitable for androgenetic alopecia (excessive oil secretion), and the principle is that the ethanol system efficiently dissolves liposoluble active substances (such as tanshinone and Cacumen Platycladi flavonoids), and uses the sebaceous gland opening as the drug penetration channel. The concentration difference generated by the evaporation of ethanol drives the drug to diffuse to the deep part of the hair follicle, especially targeting the hair papilla area rich in 5α-reductase. Zingibain protease in fresh ginger juice can gently degrade the keratin plug, solving the problem of hair follicle blockage in patients with seborrheic alopecia.
[0044] Gel (hydration and sustained release type) is suitable for sensitive scalp / long-term maintenance needs, and the principle is that the carbomer matrix forms a three-dimensional network structure when it comes into contact with water, producing a triple effect: ① water increases the permeability of the stratum corneum; ② biological adhesion prolongs the drug retention time (up to 6-8 hours); ③ glycerol maintains the water balance of the scalp. The water-alcohol double extraction process ensures the simultaneous acquisition of hydrophilic (angelica polysaccharide) and hydrophobic (tanshinone) components, achieving full-layer nourishment of the hair follicle.
[0045] Spray (flash-through broad coverage type) adaptation scene: alopecia areata / diffuse sparse, principle of action: nitrogen ketone-ice piece cooperates to form "transdermal enhancement pole": nitrogen ketone inserts into the lipid bilayer of the stratum corneum to expand the gap, and ice piece promotes drug cell bypass transport. Atomization injection realizes uniform distribution of drugs between hair follicles, especially for multiple alopecia areata lesions. The transient cooling effect caused by ethanol evaporation can relieve the burning sensation of the scalp in blood-heat type hair loss.
[0046] Tincture adopts low-temperature extraction (25±2℃), which maximizes the activity of heat-sensitive components (such as volatile hair growth-promoting factors in Platycladus orientalis); The water extraction and alcohol precipitation process of the gel has double purification value: water decoction extracts polysaccharide immunomodulatory substances, and alcohol precipitation removes large molecular impurities such as starch to reduce the risk of sensitization; The ultrasonic-assisted extraction of the spray breaks the plant cells through cavitation effect, which increases the yield of lipid-soluble active ingredients by more than 40%.
[0047] The preparation realizes the precise delivery of drugs in the target area of the scalp through three-level regulation: first-level regulation (dosage form matrix): ethanol in tincture as "penetration carrier", carbomer in gel as "sustained-release warehouse", and spray droplet size (D50=52.3μm) to control epidermal deposition rate; second-level regulation (transdermal components): ice piece-nitrogen ketone-ginger build a gradient penetration system, ice piece acts on the surface layer of stratum corneum (0-2h), nitrogen ketone acts on the deep layer (2-8h), and ginger continuously improves local microcirculation; third-level regulation (component synergy): danshensu enhances the permeability of hair follicle blood vessels, allowing macromolecules such as eclipta alba flavones to enter the hair papilla.
[0048] Compared with minoxidil simply stimulating hair follicle metabolism, the present scheme establishes a physiological barrier against recurrence through three mechanisms: polygonum multiflorum polysaccharide up-regulates Sox9 expression of hair follicle stem cells, enhancing hair follicle regeneration reserve; ligustrum lucidum glycoside inhibits TNF-α-mediated immune attack on hair follicles (especially for alopecia areata); rhizoma bletillae volatile oil regulates PPARγ receptors of sebaceous glands, improving the sebum environment from the source.
[0049] It should be noted that the above examples are only used to illustrate the technical solutions of the present application and are not limiting. Although the present application has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solutions of the present application can be modified or replaced by equivalents without departing from the spirit and scope of the present application, which should be covered in the scope of the claims of the present application.
Claims
1. A Chinese medicine external preparation for treating alopecia, characterized in that it comprises the following ingredients in parts by weight: Radix Polygoni Multiflori 15-30 parts, Folium Platycladi 10-25 parts, Radix Salviae Miltiorrhizae 10-20 parts, Radix Angelicae Sinensis 8-15 parts, Rhizoma Chuanxiong 5-12 parts, Herba Ecliptae 8-15 parts, Fructus Ligustri Lucidi 8-15 parts, Herba Lycopodii 5-10 parts, Zingiber officinale 3-8 parts or Zingiber officinale volatile oil 0.1-0.5 parts, Borneolum Syntheticum 0.5-2 parts, Radix Glycyrrhizae 3-8 parts. The ingredients are in the following proportions: Radix Polygoni Multiflori 25 parts, Folium Platycladi 20 parts, Radix Salviae Miltiorrhizae 15 parts, Radix Angelicae Sinensis 12 parts, Rhizoma Chuanxiong 10 parts, Herba Ecliptae 12 parts, Fructus Ligustri Lucidi 12 parts, Herba Lycopodii 8 parts, Zingiber officinale 5 parts or Zingiber officinale volatile oil 0.3 parts, Borneolum Syntheticum 1 part, Radix Glycyrrhizae 5 parts.
2. The external preparation of traditional Chinese medicine for treating alopecia according to claim 1, characterized in that: The preparation is in the form of tincture, gel or spray.
3. The external preparation of traditional Chinese medicine for treating alopecia according to claim 1 or 2, characterized in that: When it is tincture, the preparation comprises the following steps:
4. The external preparation of traditional Chinese medicine for treating alopecia according to claim 1, characterized in that: a) The ingredients are ground and extracted with 60-75% ethanol for 7-14 days (1:5-1:8 of solid to liquid); b) After filtration, Zingiber officinale juice / volatile oil and Borneolum Syntheticum are added; c) The volume is made up to 1.0-1.5 g of crude drug per ml. When it is gel, the preparation comprises the following steps:
5. The external preparation of traditional Chinese medicine for treating alopecia according to claim 1, characterized in that: a) The ingredients are decocted and concentrated to 1.10-1.20 g of clear extract per ml; b) The extract is alcohol precipitated to 60-70% alcohol content, and the supernatant is concentrated; c) The pH is adjusted to 6.0-7.0 after mixing with Carbomer base; d) Zingiber officinale components, Borneolum Syntheticum and humectant are added. When it is spray, the preparation comprises the following steps:
6. The external preparation of traditional Chinese medicine for treating alopecia according to claim 1, characterized in that: a) The ingredients are extracted with 60-75% ethanol; b) The filtrate is added with Borneolum Syntheticum and 0.5-2.0% azone; c) The volume is made up with water, and the preparation is filtered and packed. The humectant is glycerol, and its amount is 3-8% of the total preparation.
7. The Chinese medicinal external preparation gel for treating alopecia according to claim 5, characterized in that: The extraction temperature is 20-30°C, and the mixture is stirred 1-2 times per day.
8. The external preparation of traditional Chinese medicine for treating alopecia according to claim 4, characterized in that: The preparation contains the transdermal enhancer azone, and its amount is 1.0%.
9. The external preparation of traditional Chinese medicine for treating alopecia according to claim 6, characterized in that:
10. Use of the Chinese medicine external preparation for treating alopecia according to any one of claims 1-9 in the preparation of a medicine for treating androgenic alopecia or alopecia areata.