A composition for hair growth and hair blackening and a method for preparing the same

Abstract

This invention relates to a composition for promoting hair growth and darkening hair, and a method for preparing the same. The composition comprises custard apple seeds, bitter thorn root, chicken bone incense, jujube kernel, sophora root, winter melon seeds, black nightshade fruit, oxalis, amla leaves, elm seeds, white pear leaves, coriander seeds, and shepherd's purse root; or the composition comprises bitter thorn root, chicken bone incense, sophora root, black nightshade fruit, oxalis, amla leaves, green jade fan, kangaroo claw flower, and Panax notoginseng. In some embodiments, the composition exhibits hair growth, darkening, and follicle activation effects comparable to or even better than the positive control.

Description

Technical Field

[0001] This invention relates to the pharmaceutical field, specifically to a hair growth and hair darkening composition, its pharmaceutical uses, and a preparation method thereof. Background Technology

[0002] Hair, as an important organ on the human body surface, not only has physiological functions such as protecting the skin, regulating body temperature, and participating in sensory transmission, but it is also an important component of human appearance, closely related to an individual's gender characteristics, aesthetic preferences, and social identity. With the accelerated pace of society, increased environmental pollution, unbalanced diets, and generally increased mental stress, the incidence of hair-related problems such as hair loss, thinning hair, and premature graying has risen significantly, showing a trend of affecting younger people and becoming more widespread, thus becoming a globally concerning health and quality of life issue.

[0003] Hair loss comes in many complex and diverse forms, with common types including androgenetic alopecia, alopecia areata, telogen effluvium, and cicatricial alopecia. Among these, androgenetic alopecia, due to its close relationship with genetics, endocrine function, and age, has an extremely high incidence rate and is the most widespread type of hair loss affecting the population. This type of hair loss typically manifests as gradual atrophy of hair follicles, thinning and softening of hair shafts, and ultimately loss of hair regrowth ability. Gray hair, on the other hand, is usually associated with impaired melanin synthesis, decreased activity of melanocytes in hair follicles, and oxidative stress. While it does not affect health, it significantly impacts an individual's appearance and psychological state, causing considerable psychological burden, especially among young people.

[0004] Market research data shows that the global market for hair regrowth and hair loss prevention products has exceeded US$10 billion and is growing at an average annual rate of over 5%. Taking China as an example, data from 2023 indicates that over 250 million people aged 18 and above experience varying degrees of hair loss or hair quality problems, with men accounting for about 60% of these cases, and the number of women experiencing hair loss also rising rapidly. Correspondingly, market demand covers multiple sub-sectors including hair regrowth, hair loss prevention, hair darkening, hair care, and hair strengthening, with users placing higher demands on product safety, efficacy, naturalness, and convenience.

[0005] In existing technologies, drugs used to promote hair growth and darken hair mainly include minoxidil and finasteride. Minoxidil is a topical vasodilator that exerts its effect by promoting local blood circulation and prolonging the hair follicle growth phase. However, this type of drug is often accompanied by certain side effects, such as scalp allergies, itching, and dandruff, making it unsuitable for all patients. Long-term use may lead to dependence, and rebound hair loss is likely to occur after discontinuation. On the other hand, while hormone-based drugs such as finasteride are effective for androgenetic alopecia, their mechanism of action involves endocrine regulation, posing safety risks such as sexual dysfunction and liver damage, which particularly limits their use in women and young adults.

[0006] Compared to traditional Western medicine, natural medicines, herbal remedies, and traditional Chinese medicine formulas are gradually gaining attention in the field of hair regeneration. Traditional Chinese medicine theory holds that "hair is the surplus of blood," "the kidneys govern hair," and "the liver stores blood," indicating that hair growth is closely related to liver and kidney function. Many Chinese medicinal herbs, such as Polygonum multiflorum, Angelica sinensis, black sesame, Polygonum multiflorum, and mulberry, have long been used in dietary therapy or external formulas for hair growth and darkening, possessing a long history of traditional application.

[0007] Nevertheless, most herbal hair growth products on the market still suffer from the following major problems: poor efficacy, lack of scientific validation, and insufficient animal experimental data. Therefore, how to screen safe and effective herbal combinations based on modern pharmacology, skin biology, and pharmacology principles, and use advanced extraction and preparation processes to activate and repair hair follicle function, promote hair regeneration, and assist in restoring melanin production, is an important research direction in the field of hair growth and darkening.

[0008] In summary, there is a strong market demand for safe, effective, and convenient topical herbal medicines that can activate hair follicles, promote hair growth, and stimulate melanin production. However, existing technologies still suffer from insufficient efficacy, significant side effects, unclear ingredients, and weak evidence. There is an urgent need to develop topical herbal compositions with a clear mechanism of action, reasonable formulation, and controllable quality. In particular, herbal compositions with significant synergistic effects, comparable to or even superior to traditional Western medicines, will have immense application prospects and market value in this field. Summary of the Invention

[0009] This invention relates to a composition and its topical formulation, particularly a composition of an ethanol extract for activating hair follicles, promoting hair growth, and promoting hair darkening. It can be formulated into ointments and other forms suitable for scalp application.

[0010] The composition of the present invention is obtained by synergistic combination of specific plant ingredients and ethanol extraction, and is made into topical dosage forms such as ointment. It can significantly activate hair follicles, prolong the hair follicle growth phase, and promote hair shaft generation, thereby achieving a significant hair growth promotion effect.

[0011] Experimental data show that the specific compositions of the present invention (such as composition 7 and composition 10) exhibit hair growth, hair darkening, and hair follicle activation effects comparable to or even better than the positive control drug minoxidil in the test model, especially in terms of hair length increase, melanin value enhancement, and hair follicle number increase.

[0012] In a first aspect of the invention, a composition is provided comprising 90-110 parts by weight of custard apple seeds, bitter thorn root, chicken bone incense, jujube kernel, sophora root, winter melon seeds, black nightshade fruit, oxalis, amla leaves, elm seeds, white pear leaves, coriander seeds, and shepherd's purse root.

[0013] The present invention provides a composition comprising 100 parts by weight of each of the following: custard apple seeds, bitter thorn root, chicken bone incense, jujube kernel, sophora root, winter melon seeds, black nightshade fruit, oxalis, amla leaves, elm seeds, white pear leaves, coriander seeds, and shepherd's purse root.

[0014] The present invention provides a composition comprising 90-110 parts by weight of custard apple seeds, 90-110 parts by weight of bitter thorn root, 90-110 parts by weight of chicken bone incense, 90-110 parts by weight of jujube kernel, 90-110 parts by weight of sophora root, 90-110 parts by weight of winter melon seeds, 90-110 parts by weight of black nightshade fruit, 90-110 parts by weight of oxalis, 90-110 parts by weight of amla leaves, 90-110 parts by weight of elm seeds, 90-110 parts by weight of white pear tree leaves, 90-110 parts by weight of coriander seeds, and 90-110 parts by weight of shepherd's purse root.

[0015] The present invention provides a composition comprising 100 parts by weight of custard apple seeds, 100 parts by weight of bitter thorn root, 100 parts by weight of chicken bone incense, 100 parts by weight of jujube kernel, 100 parts by weight of sophora root, 100 parts by weight of winter melon seeds, 100 parts by weight of black nightshade fruit, 100 parts by weight of oxalis, 100 parts by weight of amla leaves, 100 parts by weight of elm seeds, 100 parts by weight of white pear tree leaves, 100 parts by weight of coriander seeds, and 100 parts by weight of shepherd's purse root.

[0016] The present invention provides a composition comprising 90-110 parts by weight of bitter thorn root, 90-110 parts by weight of chicken bone incense, 90-110 parts by weight of sophora root, 90-110 parts by weight of black nightshade fruit, 90-110 parts by weight of oxalis, 90-110 parts by weight of amla leaf, 180-220 parts by weight of green jade fan, 180-220 parts by weight of kangaroo claw flower, and 180-220 parts by weight of Panax notoginseng.

[0017] In some embodiments of the present invention, the composition comprises 100 parts by weight of bitter thorn root, 100 parts by weight of chicken bone incense, 100 parts by weight of sophora root, 100 parts by weight of black nightshade fruit, 100 parts by weight of oxalis, 100 parts by weight of amla leaves, 200 parts by weight of green jade fan, 200 parts by weight of kangaroo claw flower and 200 parts by weight of Panax notoginseng.

[0018] In some embodiments of the present invention, the composition comprises a 95% ethanol reflux extract of the mixed raw materials. Optionally, the reflux time is 2 hours. Optionally, the weight of the 95% ethanol is 9-11 times the total weight of the mixed raw materials; more preferably, the weight of the 95% ethanol is 10 times the total weight of the mixed raw materials.

[0019] In some embodiments of the present invention, the custard apple seed is the dried seed of *Annona squamosa* L. In some embodiments of the present invention, the bitter thorn root is the dried root of *Sophora viciifolia* Hance. In some embodiments of the present invention, the chicken bone fragrance is the dried root of *Croton crassifolius* Geisel. In some embodiments of the present invention, the jujube pit is the dried jujube pit. In some embodiments of the present invention, the sophora root is the dried root of *Sophora japonica*. In some embodiments of the present invention, the winter melon seed is the dried mature seed of winter melon. In some embodiments of the present invention, the black nightshade fruit is the dried fruit of *Solanum nigrum*. In some embodiments of the present invention, the oxalis is the dried whole herb of *Oxalis corniculata* L. In some embodiments of the present invention, the amla leaf is the dried leaf of *Amla emblica*. In some embodiments of the present invention, the elm seed is the dried winged fruit of *Elm*. In some embodiments of the present invention, the white pear leaf is the dried leaf of *Pyrus pyrifolia*. In some embodiments of the present invention, the coriander seeds are dried coriander seeds. In some embodiments of the present invention, the shepherd's purse root is the dried root of shepherd's purse. In some embodiments of the present invention, the Panax notoginseng is the dried root of Panax notoginseng. In some embodiments of the present invention, the green jade fan is the dried whole plant of Haworthia truncata Schönland. In some embodiments of the present invention, the kangaroo claw flower is the dried whole plant of Anigozanthos flavidus.

[0020] This invention provides a composition, the preparation method of which is as follows: take 90-110 parts by weight of each of the following herbs: custard apple seeds, bitter thorn root, chicken bone incense, jujube kernel, sophora root, winter melon seeds, black nightshade fruit, oxalis, amla leaves, elm seeds, white pear leaves, coriander seeds, and shepherd's purse root. Crush and mix them evenly to obtain a powder. Add 95% ethanol, heat to reflux, cool, filter, and remove the solvent from the filtrate to obtain the final product.

[0021] In some embodiments of the present invention, the preparation method of the composition is as follows: take 100 parts by weight of each of the following herbs: custard apple seeds, bitter thorn root, chicken bone incense, jujube kernel, sophora root, winter melon seeds, black nightshade fruit, oxalis, amla leaves, elm seeds, white pear leaves, coriander seeds, and shepherd's purse root. Crush and mix them evenly to obtain a powder. Add 9-11 times the weight of 95% ethanol to the powder, heat to reflux, maintain for 1-3 hours, cool to room temperature, filter to remove residue, collect the supernatant, remove the solvent, and the product is obtained.

[0022] In some embodiments of the present invention, the preparation method of the composition is as follows: take 100 parts by weight of each of the following herbs: custard apple seeds, bitter thorn root, chicken bone incense, jujube kernel, sophora root, winter melon seeds, black nightshade fruit, oxalis, amla leaves, elm seeds, white pear leaves, coriander seeds, and shepherd's purse root. Crush and mix them evenly to obtain a mixed powder. Add 10 times the weight of 95% ethanol to the mixed powder, heat to reflux, maintain for 2 hours, cool to room temperature, filter to remove residue, collect the supernatant, remove the solvent, and the composition is obtained.

[0023] This invention provides a composition, the preparation method of which is as follows: take 90-110 parts by weight of bitter thorn root, 90-110 parts by weight of chicken bone incense, 90-110 parts by weight of sophora root, 90-110 parts by weight of black nightshade fruit, 90-110 parts by weight of oxalis, 90-110 parts by weight of amla leaf, 180-220 parts by weight of green jade fan, 180-220 parts by weight of kangaroo claw flower, and 180-220 parts by weight of Panax notoginseng, pulverize and mix to obtain a mixed powder, add 95% ethanol, heat to reflux, filter, collect the supernatant, remove the solvent, and obtain the final product.

[0024] This invention provides a composition, the preparation method of which is as follows: Take 90-110 parts by weight of bitter thorn root, 90-110 parts by weight of chicken bone incense, 90-110 parts by weight of sophora root, 90-110 parts by weight of black nightshade fruit, 90-110 parts by weight of oxalis, 90-110 parts by weight of amla leaves, 180-220 parts by weight of green jade fan, 180-220 parts by weight of kangaroo claw flower, and 180-220 parts by weight of Panax notoginseng, pulverize them to an average particle size of 200 micrometers, mix them evenly to obtain a mixed powder, add 9-11 times the weight of 95% ethanol to the mixed powder, heat to reflux, maintain for 1-3 hours, cool, filter to remove residue, collect the supernatant, remove the solvent, and obtain the final product.

[0025] This invention provides a composition, the preparation method of which is as follows: Take 100 parts by weight of bitter thorn root, 100 parts by weight of chicken bone incense, 100 parts by weight of sophora root, 100 parts by weight of black nightshade fruit, 100 parts by weight of oxalis, 100 parts by weight of amla leaf, 200 parts by weight of green jade fan, 200 parts by weight of kangaroo claw flower, and 200 parts by weight of Panax notoginseng, pulverize them to an average particle size of 200 micrometers, mix them evenly to obtain a mixed powder, add 10 times the weight of 95% ethanol to the mixed powder, heat to reflux, maintain for 2 hours, cool to room temperature, filter to remove residue, collect the supernatant, remove the solvent, and obtain the final product.

[0026] In some embodiments of the present invention, the composition is any of the compositions described in Example 1 of the present invention. In some embodiments of the present invention, the composition is composition 7 as described in Example 1 of the present invention. In some embodiments of the present invention, the composition is composition 10 as described in Example 1 of the present invention. In some embodiments of the present invention, the composition is prepared by the method for preparing composition 7 as described in Example 1 of the present invention. In some embodiments of the present invention, the composition is prepared by the method for preparing composition 10 as described in Example 1 of the present invention.

[0027] In some embodiments of the present invention, the custard apple seed is the dried seed of *Annona squamosa* L. In some embodiments of the present invention, the bitter thorn root is the dried root of *Sophora viciifolia* Hance. In some embodiments of the present invention, the chicken bone fragrance is the dried root of *Croton crassifolius* Geisel. In some embodiments of the present invention, the jujube pit is the dried jujube pit. In some embodiments of the present invention, the sophora root is the dried root of *Sophora japonica*. In some embodiments of the present invention, the winter melon seed is the dried mature seed of winter melon. In some embodiments of the present invention, the black nightshade fruit is the dried fruit of *Solanum nigrum*. In some embodiments of the present invention, the oxalis is the dried whole herb of *Oxalis corniculata* L. In some embodiments of the present invention, the amla leaf is the dried leaf of *Amla emblica*. In some embodiments of the present invention, the elm seed is the dried winged fruit of *Elm*. In some embodiments of the present invention, the white pear leaf is the dried leaf of *Pyrus pyrifolia*. In some embodiments of the present invention, the coriander seeds are dried coriander seeds. In some embodiments of the present invention, the shepherd's purse root is the dried root of shepherd's purse. In some embodiments of the present invention, the Panax notoginseng is the dried root of Panax notoginseng. In some embodiments of the present invention, the green jade fan is the dried whole plant of Haworthia truncata Schönland. In some embodiments of the present invention, the kangaroo claw flower is the dried whole plant of Anigozanthos flavidus.

[0028] The composition is suitable for preparing topical dosage forms for activating hair follicles and promoting hair growth, such as ointments, sprays, creams, lotions, gels, patches, foams, liquid dressings, aqueous solutions, alcohol solutions, oils, lotions, powders, aerosols, effervescent tablets, serums, microemulsions, nanoemulsions, beads, films, patches, rollerball applicators, aerosol foams, creams, hair masks, and controlled-release topical gels. The composition is also suitable for preparing topical liquid formulations or pharmaceutical serums.

[0029] In a second aspect of the present invention, a method for preparing a composition is provided, the method comprising: taking 100 parts by weight each of custard apple seeds, bitter thorn root, chicken bone incense, jujube kernel, sophora root, winter melon seeds, black nightshade fruit, oxalis, amla leaves, elm seeds, white pear leaves, coriander seeds, and shepherd's purse root, pulverizing and mixing them evenly to obtain a mixed powder, adding 95% ethanol, heating to reflux, cooling, filtering to remove residue, collecting the supernatant, and removing the solvent to obtain the composition.

[0030] In some embodiments of the present invention, the preparation method includes: taking 100 parts by weight each of custard apple seeds, bitter thorn root, chicken bone incense, jujube kernel, sophora root, winter melon seeds, black nightshade fruit, oxalis, amla leaves, elm seeds, white pear leaves, coriander seeds, and shepherd's purse root, pulverizing and mixing them evenly to obtain a mixed powder, adding 10 times the weight of 95% ethanol to the mixed powder, heating to reflux, maintaining for 2 hours, cooling to room temperature, filtering to remove residue, collecting the supernatant, and removing the solvent to obtain the composition.

[0031] In a third aspect of the present invention, a method for preparing a composition is provided, the method comprising: taking 100 parts by weight of bitter thorn root, 100 parts by weight of chicken bone incense, 100 parts by weight of sophora root, 100 parts by weight of black nightshade fruit, 100 parts by weight of oxalis, 100 parts by weight of amla leaf, 200 parts by weight of green jade fan, 200 parts by weight of kangaroo claw flower, and 200 parts by weight of Panax notoginseng, pulverizing and mixing them evenly to obtain a mixed powder, adding 95% ethanol, heating to reflux, cooling, filtering to remove residue, collecting the supernatant, and removing the solvent to obtain the composition.

[0032] In some embodiments of the present invention, the preparation method includes: taking 100 parts by weight of bitter thorn root, 100 parts by weight of chicken bone incense, 100 parts by weight of sophora root, 100 parts by weight of black nightshade fruit, 100 parts by weight of oxalis, 100 parts by weight of amla leaf, 200 parts by weight of green jade fan, 200 parts by weight of kangaroo claw flower, and 200 parts by weight of Panax notoginseng, pulverizing and mixing them evenly to obtain a mixed powder, adding 10 times the weight of 95% ethanol to the mixed powder, heating to reflux, maintaining for 2 hours, cooling to room temperature, filtering to remove residue, collecting the supernatant, removing the solvent, and obtaining the composition.

[0033] The method is characterized by simple process, high extraction efficiency and good raw material stability, and is suitable for large-scale standardized production.

[0034] In some embodiments of the present invention, the custard apple seed is the dried seed of *Annona squamosa* L. In some embodiments of the present invention, the bitter thorn root is the dried root of *Sophora viciifolia* Hance. In some embodiments of the present invention, the chicken bone fragrance is the dried root of *Croton crassifolius* Geisel. In some embodiments of the present invention, the jujube pit is the dried jujube pit. In some embodiments of the present invention, the sophora root is the dried root of *Sophora japonica*. In some embodiments of the present invention, the winter melon seed is the dried mature seed of winter melon. In some embodiments of the present invention, the black nightshade fruit is the dried fruit of *Solanum nigrum*. In some embodiments of the present invention, the oxalis is the dried whole herb of *Oxalis corniculata* L. In some embodiments of the present invention, the amla leaf is the dried leaf of *Amla emblica*. In some embodiments of the present invention, the elm seed is the dried winged fruit of *Elm*. In some embodiments of the present invention, the white pear leaf is the dried leaf of *Pyrus pyrifolia*. In some embodiments of the present invention, the coriander seeds are dried coriander seeds. In some embodiments of the present invention, the shepherd's purse root is the dried root of shepherd's purse. In some embodiments of the present invention, the Panax notoginseng is the dried root of Panax notoginseng. In some embodiments of the present invention, the green jade fan is the dried whole plant of Haworthia truncata Schönland. In some embodiments of the present invention, the kangaroo claw flower is the dried whole plant of Anigozanthos flavidus.

[0035] In a fourth aspect of the invention, a medicament is provided, the medicament comprising the composition described in the invention.

[0036] In some embodiments of the invention, the composition promotes hair growth. In some embodiments of the invention, the composition promotes hair darkening. In some embodiments of the invention, the composition promotes hair follicle growth.

[0037] In some embodiments of the present invention, the drug is in the form of an ointment or similar dosage form. In some embodiments of the present invention, the drug can be formulated into a topical dosage form suitable for transdermal use, including but not limited to ointments, creams, gels, emulsions, patches, films, lotions, drops, sprays, medicinal serums, foams, oils, essences, microemulsions, nanoemulsions, gel patches, and penetration-enhancing formulations. Such formulations facilitate the transdermal absorption of the active ingredients in the composition, acting on the hair follicle area to activate hair follicles and promote hair growth.

[0038] In a fifth aspect of the invention, the use of the composition as described herein in the preparation of a medicament for hair growth, hair darkening, or promoting hair follicle growth is provided.

[0039] In some embodiments of the present invention, the use of the compositions described herein is provided in the preparation of medicaments for hair growth. In some embodiments of the present invention, the use of the compositions described herein is provided in the preparation of medicaments for hair darkening. In some embodiments of the present invention, the use of the compositions described herein is provided in the preparation of medicaments for promoting hair follicle growth.

[0040] In some embodiments of the present invention, the use of the compositions described herein is provided in the preparation of medicaments for the prevention or treatment of androgenetic alopecia. In some embodiments of the present invention, the use of the compositions described herein is provided in the preparation of medicaments for the treatment of androgenetic alopecia. In some embodiments of the present invention, the use of the compositions described herein is provided in the preparation of medicaments for the prevention of androgenetic alopecia.

[0041] In some embodiments of the present invention

[0042] Technical effects of the present invention: Experimental data from the examples show that the specific compositions of the present invention (such as composition 7 and composition 10) exhibit hair growth, hair darkening, and hair follicle activation effects comparable to or even better than the positive control drug minoxidil in the test model. In particular, there are significant differences in hair length growth, melanin value enhancement, and hair follicle number increase, indicating that the compositions have a synergistic effect. Detailed Implementation

[0043] The following examples further illustrate this disclosure, but do not limit this disclosure to the scope of the examples described. Experimental methods in the following examples, unless otherwise specified, are performed according to conventional methods and conditions, or as selected in the product instructions. The reagents and raw materials used in this disclosure are commercially available.

[0044] The raw materials used in the following examples are: custard apple seeds (dried seeds of Annona squamosa L.), dried roots of Sophora viciifolia Hance, dried roots of Croton crassifolius Geisel., dried jujube kernels, dried roots of Sophora japonica, dried mature seeds of winter melon, dried fruits of Solanum nigrum, dried whole plant of Oxalis corniculata L., dried leaves of Phyllanthus emblica, dried winged fruits of Elm, dried leaves of Pyrus pyrifolia, dried seeds of Coriander, dried roots of Capsella bursa-pastoris; dried roots of Panax notoginseng; dried whole plant of Haworthia truncata Schönland; and dried whole plant of Anigozanthos flavidus.

[0045] Example 1: Preparation of the Composition

[0046] Take 100 parts by weight each of the following ingredients: custard apple seeds, jujube pits, winter melon seeds, black nightshade fruit, oxalis, amla leaves, elm seeds, white pear leaves, coriander seeds, and shepherd's purse roots. Wash and dry each ingredient separately, and grind them to an average particle size of approximately 200 micrometers. Mix them thoroughly to obtain a powder. Add 10 times the weight of 95% ethanol to the powder, heat to reflux, and maintain for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 1.

[0047] Take 100 parts by weight each of the following ingredients: custard apple seeds, bitter thorn root, chicken bone incense, jujube kernel, sophora root, winter melon seeds, elm seeds, white pear leaves, coriander seeds, and shepherd's purse root. Wash and dry each ingredient separately, and grind them to an average particle size of approximately 200 micrometers. Mix them thoroughly to obtain a powder. Add 10 times the weight of 95% ethanol to the powder, heat to reflux, and maintain for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 2.

[0048] Take 100 parts by weight of each of the following herbs: custard apple seeds, bitter thorn root, chicken bone incense, jujube kernel, sophora root, winter melon seeds, black nightshade fruit, oxalis, elm seeds, and white pear leaves. Grind each herb to an average particle size of approximately 200 micrometers. Mix thoroughly to obtain a powder. Add 10 times the weight of 95% ethanol to the powder and heat to reflux for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 3.

[0049] Take 100 parts by weight of each of the following herbs: bitter thorn root, chicken bone incense, sophora root, black nightshade fruit, oxalis, amla leaves, coriander seeds, and shepherd's purse root. Wash and dry them separately, and pulverize them to an average particle size of about 200 micrometers. Mix them evenly to obtain a powder. Add 10 times the weight of 95% ethanol to the powder, heat to reflux, and maintain for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 4.

[0050] Take custard apple seeds, jujube pits, winter melon seeds, elm seeds, and white pear leaves, wash and dry them separately, and take 100 parts by weight of each. Grind them to an average particle size of about 200 micrometers. Mix them evenly to obtain a powder, add 10 times the weight of 95% ethanol to the powder, heat to reflux, and maintain for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 5.

[0051] Take 100 parts by weight of each of the following herbs: custard apple leaves, bitter thorn root, chicken bone incense, jujube, sophora root, winter melon peel, black nightshade fruit, oxalis, amla leaves, elm flower, dried white pear fruit, coriander seeds, and shepherd's purse root. Wash and dry each herb separately, and pulverize them to an average particle size of approximately 200 micrometers. Mix them thoroughly to obtain a powder. Add 10 times the weight of 95% ethanol to the powder, heat to reflux, and maintain for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 6.

[0052] Take 100 parts by weight of each of the following herbs: custard apple seeds, bitter thorn root, chicken bone incense, jujube kernel, sophora root, winter melon seeds, black nightshade fruit, oxalis, amla leaves, elm seeds, white pear leaves, coriander seeds, and shepherd's purse root. Wash and dry them separately, and grind each to an average particle size of approximately 200 micrometers. Mix them thoroughly to obtain a powder. Add 10 times the weight of 95% ethanol to the powder, heat to reflux, and maintain for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 7.

[0053] Take 100 parts by weight of washed and dried custard apple seeds, 150 parts by weight of bitter thorn root, 100 parts by weight of chicken bone incense, 100 parts by weight of jujube kernels, 150 parts by weight of sophora root, 50 parts by weight of winter melon seeds, 50 parts by weight of black nightshade fruit, 30 parts by weight of oxalis, 50 parts by weight of amla leaves, 50 parts by weight of elm seeds, 50 parts by weight of white pear leaves, 50 parts by weight of coriander seeds, and 30 parts by weight of shepherd's purse root, and grind them to an average particle size of about 200 micrometers. Mix them evenly to obtain a powder, add 10 times the weight of the powder in 95% ethanol, heat to reflux, and maintain for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 8.

[0054] Take 30 parts by weight of washed and dried custard apple seeds, 50 parts by weight of bitter thorn root, 100 parts by weight of chicken bone incense, 100 parts by weight of jujube kernels, 100 parts by weight of sophora root, 50 parts by weight of winter melon seeds, 70 parts by weight of black nightshade fruit, 25 parts by weight of oxalis, 160 parts by weight of amla leaves, 150 parts by weight of elm seeds, 30 parts by weight of white pear leaves, 150 parts by weight of coriander seeds, and 150 parts by weight of shepherd's purse root, and grind them to an average particle size of about 200 micrometers. Mix them evenly to obtain a powder, add 10 times the weight of the powder in 95% ethanol, heat to reflux, and maintain for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 9.

[0055] Take 100 parts by weight of bitter thorn root, 100 parts by weight of chicken bone incense, 100 parts by weight of sophora root, 100 parts by weight of black nightshade fruit, 100 parts by weight of oxalis, 100 parts by weight of amla leaves, 200 parts by weight of green jade fan, 200 parts by weight of kangaroo claw flower, and 200 parts by weight of Panax notoginseng. Wash, dry, and pulverize them separately to an average particle size of about 200 micrometers. Mix them evenly to obtain a powder. Add 10 times the weight of the powder in 95% ethanol, heat to reflux, and maintain for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 10.

[0056] Take 200 parts by weight of *Gynostemma pentaphyllum*, 200 parts by weight of *Kangaroo Claw Flower*, and 200 parts by weight of *Panax notoginseng*, wash, dry, and pulverize them to an average particle size of approximately 200 micrometers. Mix them evenly to obtain a powder, add 10 times the weight of 95% ethanol to the powder, heat to reflux, and maintain for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 11.

[0057] Take 100 parts by weight of bitter thorn root, 100 parts by weight of chicken bone incense, 100 parts by weight of sophora root, 100 parts by weight of black nightshade fruit, 100 parts by weight of oxalis, 100 parts by weight of amla leaves, 30 parts by weight of green jade fan, 30 parts by weight of kangaroo claw flower, and 30 parts by weight of Panax notoginseng. Wash, dry, and pulverize them to an average particle size of about 200 micrometers. Mix them evenly to obtain a powder. Add 10 times the weight of the powder in 95% ethanol, heat to reflux, and maintain for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 12.

[0058] Take 100 parts by weight of bitter thorn root, 100 parts by weight of chicken bone incense, 100 parts by weight of sophora root, 100 parts by weight of black nightshade fruit, 100 parts by weight of oxalis, and 100 parts by weight of amla leaves. Wash, dry, and pulverize them to an average particle size of about 200 micrometers. Mix them evenly to obtain a powder. Add 10 times the weight of the powder in 95% ethanol, heat to reflux, and maintain for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 13.

[0059] Take 100 parts by weight of bitter thorn root, 100 parts by weight of chicken bone incense, 100 parts by weight of sophora root, 100 parts by weight of black nightshade fruit, 100 parts by weight of oxalis, 100 parts by weight of amla leaves, and 200 parts by weight of Panax notoginseng. Wash, dry, and pulverize them to an average particle size of about 200 micrometers. Mix them evenly to obtain a powder. Add 10 times the weight of the powder in 95% ethanol, heat to reflux, and maintain for 2 hours. Cool to room temperature, filter to remove residue, and collect the supernatant. Evaporate to dryness under reduced pressure at 30°C using a rotary evaporator to obtain composition 14.

[0060] Example 2: Hair regrowth and other effects test

[0061] Weigh each composition prepared as described in Example 1 and prepare solutions of the desired concentrations (see Table 1) with 70% ethanol.

[0062] Seven-week-old male C57BL / 6J mice, weighing 20.5-21.3 grams, were used. They were randomly divided into groups of 10 mice each. A 1cm × 1cm area was selected on the upper left back of each mouse and the hair was removed.

[0063] Prepare a 70% ethanol solution of testosterone with a concentration of 5 mg / mL.

[0064] Starting from day 1 after hair removal, 0.1 mL of 70% ethanol solution of testosterone was evenly applied to the hair removal area on the back of the model group mice; once a day for 9 consecutive days.

[0065] Starting from day 1 after hair removal, mice in the minoxidil group had 0.1 mL of 70% ethanol solution of testosterone evenly applied to the hair removal area on their backs, and 0.1 mL of 5% (w / v) minoxidil solution evenly applied to their backs 2 hours later. Testosterone and minoxidil were applied once each day for 9 consecutive days.

[0066] Blank group: No processing.

[0067] Each composition group: Starting from day 1 after hair removal, 0.1 mL of 70% ethanol solution of testosterone was evenly applied to the back of each mouse in each group, and 0.1 mL of 70% ethanol solution of the corresponding composition was evenly applied to the back of each mouse 2 hours later; testosterone and the composition were applied once each day for 9 consecutive days.

[0068] Mice in each group were fed and given water normally.

[0069] On the 10th day after hair removal, the hair growth of the skin at the hair removal site of the mice was photographed and recorded. Five skin areas were randomly selected at the modeling site, and the skin melanin value was measured using a skin color analyzer. Then, 10 newly grown hairs were randomly plucked from the hair removal site of each mouse, and the length of the hairs was measured with a ruler. The average length was calculated. The results were taken as the average hair length of animals within each group. See Table 1.

[0070] On day 10 post-hair removal, the hair length in the bald area on the back of mice in the model group was significantly shorter than that in the blank control group, showing a statistically significant difference. The hair length in the minoxidil group, composition 7 (100 mg / mL), composition 7 (50 mg / mL), composition 10 (100 mg / mL), and composition 10 (50 mg / mL) was significantly longer than that in the model group and the other composition groups, respectively, showing a statistically significant difference (P<0.05). This indicates that minoxidil, composition 7, and composition 10 have significantly stronger hair growth-promoting activities than other compositions. Composition 10 has a synergistic effect. Compared with compositions 8 and 9, composition 7 differs only in the quality of raw materials, but its activity is significantly improved; composition 7 differs from compositions 1-6 in the type of raw materials or the site of application, but its activity is significantly improved, thus composition 7 achieved unexpected technical effects. Similarly, composition 10 also achieved unexpected technical effects. Lower concentrations of composition 7 and composition 10 still exhibit strong activity.

[0071] Table 1. Hair length in the treated area on day 10 after hair removal

[0072]

[0073] On day 10 post-hair removal, the melanin index of the hair-removed area on the back of mice was measured using a skin melanin analyzer (Mexameter® MX 18) (a higher value indicates higher melanin content). The relative value of the melanin index of the back area of ​​mice compared to the control group was calculated (melanin index of each group / melanin index of the control group). Then, the mean value of each group was calculated. See Table 2.

[0074] On day 10 after hair removal, the melanin levels in the hair-removed areas on the backs of mice in the model group were significantly lower than those in the blank control group, showing a statistically significant difference. The melanin levels in the minoxidil group, composition 7 group (100 mg / mL), composition 7 group (50 mg / mL), composition 10 group (100 mg / mL), and composition 10 group (50 mg / mL) were all significantly higher than those in the model group and the other composition groups, respectively, showing statistically significant differences (P<0.05).

[0075] Table 2. Relative melanin content in the treated area on day 10 after hair removal

[0076]

[0077] Melanin synthesis in mouse skin is closely related to hair follicle growth. Hair follicles in the anagen phase stimulate the activity of melanocytes in the basal layer of the epidermis, leading to increased skin pigmentation, which is visibly "darkened" by the naked eye. After treatment with the composition, increased pigmentation occurs, and the surface hair follicles are activated and enter the anagen phase.

[0078] On the 10th day after hair removal, the newly grown hair in the hair removal area of ​​the model group animals was noticeably sparse and the hair was fine; the newly grown hair in the hair removal area of ​​the minoxidil group, combination group 7, and combination group 10 was the densest, darkest, and thickest.

[0079] Skin samples were taken from the modeling sites of mice 10 days after hair removal, fixed in 4% formaldehyde solution, dehydrated, embedded in paraffin, sectioned, and stained with hematoxylin and eosin (HE). The sections were then scanned and analyzed using a digital tissue scanner. The number of hair follicles was counted, and the average value of each group was calculated.

[0080] HE staining showed that the number of hair follicles in mice in the minoxidil group, composition 7 group (50 mg / mL), and composition 10 group (50 mg / mL) were 18.3 per 150 square micrometers, 18.6 per 150 square micrometers, and 19.3 per 150 square micrometers, respectively, which were significantly higher than those in the model group (3.7 per 150 square micrometers) and other composition groups (compositions 1-6, 8-9, and 11-14, 100 mg / mL; number of hair follicles 3.9 to 10.4 per 150 square micrometers), reaching statistical significance (P<0.01). The number of hair follicles in composition 7 group (100 mg / mL) and composition 10 group (100 mg / mL) (>24.8 per 150 square micrometers) was significantly higher than that in the minoxidil group, with statistical significance (P<0.01).

[0081] Example 3: Preparation of Hair Growth Topical Ointment

[0082] Add 5g of composition 7 prepared as described in Example 1 to 75g of white petrolatum and 10g of lanolin, heat in a water bath to 60°C, and stir until homogeneous. Separately, take 8g of propylene glycol, 1g of phenoxyethanol (preservative), and an appropriate amount of deionized water, and mix them evenly. Combine and stir, then slowly pour the aqueous phase into the oil phase, continuing to stir until emulsified and homogeneous, and cool to room temperature. A semi-solid ointment-like topical medicine is obtained. After stirring evenly, dispense into aluminum tubes or wide-mouth bottles, store away from light, and label as hair growth topical ointment.

[0083] Add 5g of the composition 10 prepared as described in Example 1 to 75g of white petrolatum and 10g of lanolin, heat in a water bath to 60°C, and stir until homogeneous. Separately, take 8g of propylene glycol, 1g of phenoxyethanol (preservative), and an appropriate amount of deionized water, and mix them evenly. Combine and stir, then slowly pour the aqueous phase into the oil phase, continuing to stir until emulsified and homogeneous, and cool to room temperature. A semi-solid ointment-like topical medicine is obtained. After stirring evenly, dispense into aluminum tubes or wide-mouth bottles, store away from light, and label as hair growth topical ointment.

[0084] Example 4: Preparation of Hair Growth Topical Solution

[0085] Oil phase pre-dissolution: 3g of composition 7 or composition 10 prepared as described in Example 1 is mixed with 5g of MCT oil (caprylic / capric triglyceride) and 2.5g of PEG-40 hydrogenated castor oil, and heated to 40°C and stirred thoroughly until homogeneous.

[0086] Aqueous phase preparation: Mix 80g of deionized water, 3g of glycerin, 5g of propylene glycol, 0.5g of lecithin, and 0.1g of sodium hyaluronate evenly.

[0087] Mixing and emulsification: Slowly add the oil phase to the aqueous phase and stir for 5 minutes at approximately 8000 rpm using a high-shear emulsifier to form a microemulsion or transparent emulsion.

[0088] Adjustment and filling: Adjust the pH to 5.5-6.0, filter, and fill in the dark. This yields the hair growth external solution.

Claims

1. A composition characterized in that, The composition consists of Annona squamosa seeds, Rhus succedaneum roots, Rubus corchorifolius roots, Aquilaria sinensis roots, Radix Sophorae Tonkinensis, Benincasa cerifera seeds, Solanum nigrum fruits, Oxalis corniculata, Phyllanthus emblica leaves, Euonymus alatus, Pyrus xeridifolia leaves, Coriandrum sativum seeds, and Brassica rapa roots, and each is 90-110 parts by weight.

2. A composition characterized in that, The composition consists of Annona squamosa seeds, Rhus succedaneum roots, Rubus corchorifolius roots, Aquilaria sinensis roots, Radix Sophorae Tonkinensis, Benincasa cerifera seeds, Solanum nigrum fruits, Oxalis corniculata, Phyllanthus emblica leaves, Euonymus alatus, Pyrus xeridifolia leaves, Coriandrum sativum seeds, and Brassica rapa roots, and each is 100 parts by weight.

3. The composition of claim 1 or 2, wherein the composition is prepared by taking Annona squamosa seeds, Rhus succedaneum roots, Rubus corchorifolius roots, Aquilaria sinensis roots, Radix Sophorae Tonkinensis, Benincasa cerifera seeds, Solanum nigrum fruits, Oxalis corniculata, Phyllanthus emblica leaves, Euonymus alatus, Pyrus xeridifolia leaves, Coriandrum sativum seeds, and Brassica rapa roots, each 90-110 parts by weight, crushing and mixing to obtain a mixed powder, adding 95% ethanol, heating to reflux, cooling, filtering, removing the solvent from the filtrate, and obtaining the composition.

4. The composition of claim 1 or 2, wherein the composition is prepared by taking Annona squamosa seeds, Rhus succedaneum roots, Rubus corchorifolius roots, Aquilaria sinensis roots, Radix Sophorae Tonkinensis, Benincasa cerifera seeds, Solanum nigrum fruits, Oxalis corniculata, Phyllanthus emblica leaves, Euonymus alatus, Pyrus xeridifolia leaves, Coriandrum sativum seeds, and Brassica rapa roots, each 100 parts by weight, crushing and mixing to obtain a mixed powder, adding 10 times the weight of 95% ethanol to the mixed powder, heating to reflux for 2 hours, cooling to room temperature, filtering to remove the residue, collecting the supernatant, and removing the solvent.

5. A composition consisting of: Rhus succedaneum roots 90-110 parts by weight, Rubus corchorifolius roots 90-110 parts by weight, Radix Sophorae Tonkinensis 90-110 parts by weight, Solanum nigrum fruits 90-110 parts by weight, Oxalis corniculata 90-110 parts by weight, Phyllanthus emblica leaves 90-110 parts by weight, Euonymus alatus 180-220 parts by weight, Acacia auriculiformis 180-220 parts by weight, and Panax notoginseng 180-220 parts by weight.

6. A composition, wherein the composition is prepared by taking Rhus succedaneum roots 90-110 parts by weight, Rubus corchorifolius roots 90-110 parts by weight, Radix Sophorae Tonkinensis 90-110 parts by weight, Solanum nigrum fruits 90-110 parts by weight, Oxalis corniculata 90-110 parts by weight, Phyllanthus emblica leaves 90-110 parts by weight, Euonymus alatus 180-220 parts by weight, Acacia auriculiformis 180-220 parts by weight, Panax notoginseng 180-220 parts by weight, crushing and mixing to obtain a mixed powder, adding 95% ethanol, heating to reflux, filtering, collecting the supernatant, and removing the solvent.

7. A process for the preparation of a composition as claimed in claim 1 or 2, said process comprising: Annona squamosa seeds, Rhus succedaneum roots, Rubus corchorifolius roots, Aquilaria sinensis roots, Radix Sophorae Tonkinensis, Benincasa cerifera seeds, Solanum nigrum fruits, Oxalis corniculata, Phyllanthus emblica leaves, Euonymus alatus, Pyrus xeridifolia leaves, Coriandrum sativum seeds, and Brassica rapa roots, each 100 parts by weight, crushing and mixing to obtain a mixed powder, adding 95% ethanol, heating to reflux, cooling, filtering to remove the residue, collecting the supernatant, and removing the solvent.

8. A medicament comprising the composition of any one of claims 1-6.

9. Use of the composition of any one of claims 1-6 in the preparation of a medicament for hair growth or hair blackening.

10. Use of the composition of any one of claims 1-6 in the preparation of a medicament for preventing or treating androgenetic alopecia.

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