Compositions comprising bemaprost and uses thereof

Abstract

The present invention provides a composition comprising bemaprost or a physiologically acceptable salt, solvate or prodrug thereof, and further comprising a natural product or a physiologically acceptable non-covalent derivative thereof. The invention also provides a pharmaceutical preparation and a cosmetic containing the composition. The invention further provides uses of the composition, pharmaceutical formulations and cosmetics. The composition provided by the invention can have different hair growth promoting mechanisms to achieve a synergistic effect of preventing and treating alopecia, so that the composition can be applied to alopecia of different pathological types, especially alopecia caused by chemotherapy. The composition provided by the invention has an obviously improved curative effect, so that the dosage can be reduced, the medication safety can be improved, and the economic pressure and side effects of a user can be relieved. The active ingredients are wide in source, simple and convenient to prepare, suitable for large-scale production and application, and wide in application prospect and clinical value.

Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a composition comprising bimatoprost, and also to a pharmaceutical preparation and cosmetics comprising the composition and their use in preventing and / or treating hair loss diseases and / or promoting hair growth. Background Art

[0002] In recent years, with the accelerating pace of modern life and the increasing work pressure, coupled with unhealthy lifestyle habits such as staying up late and irregular eating, the number of patients with hair loss diseases has increased and is showing a clear trend of younger age. The common types of hair loss in clinical practice mainly include androgenic alopecia, alopecia areata, alopecia caused by chemotherapy or radiotherapy, growth effluvium and telogen effluvium. Although hair loss is not life-threatening, it will bring great social barriers and psychological burden to patients, seriously affecting their quality of life (Wall D, et al. 2022, Fac Rev). Although the global market size of hair loss treatment drugs is predicted to be as high as tens of billions of dollars, there are currently only three drugs approved by the FDA for marketing: finasteride, minoxidil and baricitinib. Finasteride reduces the production of dihydrotestosterone by inhibiting 5α-reductase; minoxidil increases hair follicle nutrition by promoting vascular microcirculation; baricitinib reduces hair loss by inhibiting the JAK-STAT signaling pathway (Yu Ruiyao. 2001, Dermatology and Venereology; Han JH, et al. 2004, J Dermatol Sci; King B, et al. 2021, J Am Acad Dermatol). Although the above three drugs have different mechanisms of action for treating hair loss, none of them can promote the growth of hair follicle stem cells, and they are prone to relapse after drug withdrawal, and all have adverse reactions and shortcomings to varying degrees (Melcangi RC, et al. 2017, J Steroid Biochem Mol Biol; Wu Qiaofang, et al. 2018, Journal of Clinical Dermatology; Gilhar A, et al. 2019, Lancet), so there is still a large unmet clinical need in the field of hair loss treatment.

[0003] Bimatoprost was originally developed for the treatment of glaucoma and is recommended as a first-line drug for the treatment of primary open-angle glaucoma in the Chinese Glaucoma Guidelines (Chinese Glaucoma Guidelines. 2020, Chinese Journal of Ophthalmology). However, during clinical application, it was observed that patients often developed eyelash hypertrichosis after using bimatoprost, which was manifested as thicker and longer eyelashes (Tosti A, et al. 2004, J Am Acad Dermatol). Based on this, Allergan developed bimatoprost for the promotion of hair growth, and it was approved by the US FDA in 2008 for the treatment of hypotrichosis (Cohen J L. 2010, Dermatol Surg). Unlike finasteride, minoxidil and baricitinib, bimatoprost has a unique mechanism of action in promoting hair growth, specifically activating the Wnt / β-catenin signaling pathway, which can effectively promote the growth and development of hair follicle stem cells, thereby promoting hair growth (Tauchi M, et al. 2010, Br J Dermatol; Liu Licheng, et al. 2021, Chinese Medical Journal). Based on the clear effectiveness of bimatoprost in promoting hair growth, there are more and more research reports on its clinical use in the treatment of androgenic alopecia, alopecia areata, chemotherapy or radiotherapy-induced hair loss and hypotrichosis (Smith S, et al. 2012, J Am Acad Derm; Beer KR, et al. 2013, Dermatol Surg; Zaher H, et al. 2015, Dermatology; Glaser DA, et al. 2015, Br J Dermatol; Barrón-Hernández YL, et al. 2017, Expert Opin Investig Drugs).

[0004] Natural products can participate in regulating the hair follicle growth cycle through multiple cell growth factor pathways such as keratinocyte growth factor, hepatocyte growth factor, insulin-like growth factor-1, sonic hedgehog factor, transforming growth factor-β, and vascular endothelial growth factor, thereby nourishing hair follicles and treating hair loss (Cho EC, et al. 2020, J Ethnopharmacol). Natural products have relatively good safety, relatively few clinical side effects, relatively wide sources, and relatively low prices. In recent years, the use of natural products to treat hair loss has received more and more attention and has great development prospects. Among them, terpene natural products such as oleanolic acid and cedrol (Chinese patent CN 114796000, CN 107260710; Liu Zhenda, et al. 2022, Chinese Modern Applied Pharmacy), indole natural products such as isatis glycoside (Chinese patent CN 104873562), ketone natural products such as teruncle glycoside and baicalin (Chinese patent CN 111184773, CN 115887377; Xing F, et al. 2018, Int J Mol Med), anthraquinone natural products such as rhamnolide (Chinese patent CN 112569247; Shin JY, et al. 2020, BMC Complement Med Ther), stilbene natural products such as diphenyl glycoside (Chinese patent CN 105663148; Li YF, 2015, Evid Based Complement Alternat Med), diketone natural products such as curcumin (Chinese patent CN 113041246, CN111526861; Mao YQ, et al. 2022, J Cosmet Dermatol; Ma Dongxue, et al. 2022, Chinese Journal of Integrated Traditional and Western Medicine Dermatology and Venereology), etc., all have relevant literature and patent reports that can promote hair growth. Summary of the invention

[0005] In order to make up for the deficiencies in the prior art, an object of the present invention is to provide a composition which has excellent functions of promoting hair growth and reducing hair loss, and can be effectively used to prevent, improve and treat hair loss and related diseases or symptoms.

[0006] Another object of the present invention is to provide a pharmaceutical preparation and a cosmetic comprising the composition.

[0007] Another object of the present invention is to provide uses of the composition, pharmaceutical preparation and cosmetics.

[0008] The first aspect of the present invention provides a composition comprising an active component A and an active component B, wherein the active component A is bimatoprost or a physiologically acceptable salt, solvate or prodrug thereof, and the active component B is a natural product or a physiologically acceptable non-covalent derivative thereof.

[0009] The inventors of the present invention have discovered through research that active component A and active component B have different mechanisms of action in promoting hair growth and reducing hair loss, and each has good therapeutic effects. When the two are used in combination, they can produce a significant synergistic effect, that is, the therapeutic effect is significantly better than when the two are used alone. Therefore, the present invention provides a composition with better efficacy and higher safety, which can effectively prevent, improve or treat various types of hair loss, promote hair growth, reduce hair loss, and provide more and better choices for hair loss patients.

[0010] In the composition provided by the present invention, the active component A and the active component B can be any dosage ratio within the acceptable range for the subject or patient. In some preferred embodiments, the molar ratio of the active component A to the active component B can be 0.1-5:10-300. In some more preferred embodiments, the molar ratio of the active component A to the active component B can be 1-5:100-300. In other more preferred embodiments, the molar ratio of the active component A to the active component B can be 0.8-1.2:80-120. In some most preferred embodiments, the molar ratio of the active component A to the active component B can be 1:100.

[0011] In the composition provided by the present invention, the active component B may be a natural product or a physiologically acceptable salt, solvate or co-crystal thereof.

[0012] In some preferred embodiments, the natural product may be one or more of the common terpene natural products, indole natural products, flavonoid natural products, anthraquinone natural products, stilbene natural products, and diketone natural products that have hair growth promoting effects.

[0013] In some more preferred embodiments, the terpene natural products include but are not limited to oleanolic acid and / or cedrol; the indole natural products include but are not limited to isatis glycosides; the flavonoid natural products include but are not limited to teruncosides and / or baicalin; the anthraquinone natural products include but are not limited to emodin; the stilbene natural products include but are not limited to stilbene glycosides; the diketone natural products include but are not limited to curcumin.

[0014] In some most preferred embodiments, the natural product is one or more of oleanolic acid, isatisin, and baicalin.

[0015] The second aspect of the present invention provides a pharmaceutical preparation comprising the composition described in any one of the above technical solutions and a pharmaceutically acceptable excipient and / or adjuvant.

[0016] In some preferred embodiments, the pharmaceutical preparation may also contain other active ingredients having physiological effects such as treating hair loss and promoting hair growth, for example, finasteride, minoxidil, baricitinib, etc., which have been clinically applied.

[0017] The third aspect of the present invention provides a cosmetic comprising the composition described in any one of the above technical solutions and a carrier and / or auxiliary material acceptable in the field of cosmetics.

[0018] In some preferred embodiments, the cosmetics may also contain other active ingredients having physiological effects such as treating hair loss and promoting hair growth, for example, finasteride, minoxidil, baricitinib, etc., which have been clinically applied.

[0019] In the pharmaceutical preparation or cosmetic provided by the present invention, the content of the active component A can be 0.001-2% by mass. In some preferred embodiments, the content of the active component A can be 0.005-0.1%, for example, about 0.005%, about 0.01%, about 0.015%, about 0.02%, about 0.025%, about 0.03%, about 0.035%, about 0.04%, about 0.045%, about 0.05%, about 0.06%, about 0.07%, about 0.08%, about 0.09%, about 0.1% or any combination of numerical intervals. In some more preferred embodiments, the content of the active component A can be 0.01-0.05%.

[0020] In the pharmaceutical preparation provided by the present invention, the pharmaceutical preparation can be any common dosage form, including but not limited to eye drops, tinctures, liniments, paints, gels, emulsions, microneedles, patches, lotions, aerosols, etc. In some preferred embodiments, the preparation can be administered transdermally or intradermally.

[0021] The cosmetics provided by the present invention can be any common hair cosmetics, including but not limited to shampoo, conditioner, hair essence, hair oil, hair milk, scalp cream, hair gel, hair wax, hair mask, hair dye, hair growth liquid, eyelash care liquid, eyebrow care liquid, etc.

[0022] In addition to pharmaceutical preparations and cosmetics, the composition of the present invention can also be added to any other common products used to prevent and treat hair loss, promote hair growth, and reduce hair loss, such as functional health products, sanitary products, etc.

[0023] The fourth aspect of the present invention provides use of the composition described in any one of the above technical solutions in the preparation of medicines or cosmetics for preventing and / or treating hair loss diseases and / or promoting hair growth.

[0024] A fifth aspect of the present invention provides use of the pharmaceutical preparation described in any one of the above technical solutions as a drug for preventing and / or treating hair loss diseases and / or for promoting hair growth.

[0025] A sixth aspect of the present invention provides use of the cosmetic described in any one of the above technical solutions as a cosmetic for preventing and / or treating hair loss diseases and / or for promoting hair growth.

[0026] In the use provided by the present invention, the hair loss disease can be a common disease type in clinical practice or daily life or other diseases containing hair loss symptoms, including but not limited to chemotherapy-induced hair loss, radiotherapy-induced hair loss, hypolashes, hypobrows, androgenic alopecia, alopecia areata, female pattern hair loss, anagen effluvium, telogen effluvium, etc.

[0027] In some preferred embodiments, the hair loss disease is hair loss caused by chemotherapy in cancer patients.

[0028] The technical solution provided by the present invention has the following advantages:

[0029] (1) The present invention combines bimatoprost with natural products to form a composition for the first time, which can have different mechanisms for promoting hair growth and achieve synergistic effects in preventing and treating hair loss and promoting hair growth. Therefore, it can be applied to hair loss of different pathological types, especially hair loss caused by chemotherapy in cancer patients.

[0030] (2) Since the composition provided by the present invention has significantly improved therapeutic effects, it can reduce the dosage of the drug, improve the safety of the drug, and reduce the economic pressure on the user and the side effects caused by the drug.

[0031] (3) The bimatoprost and natural products used in the present invention are both mature and easily commercially available products with a wide range of sources and simple preparation. They are suitable for large-scale production and application and have broad application prospects and clinical value. DETAILED DESCRIPTION

[0032] definition

[0033] The term "acceptable" means having no long-term detrimental effect on the general health of the subject or patient.

[0034] The term "physiologically acceptable salt" refers to a salt of a compound or natural product of the present invention that retains the biological effectiveness and properties of a free acid or free base, and the free acid is obtained by reacting with a non-toxic inorganic base or organic base, or the free base is obtained by reacting with a non-toxic inorganic acid or organic acid. It can be obtained using standard procedures well known in the art. Suitable salts are listed in Remington's Pharmaceutical Scicences, 17th ed., Mack Publishing Company, Easton, Pa., 1985, p. 1418 and Journal of Pharmaceutical Science, 66, 2 (1977).

[0035] The term "solvate" refers to a physical aggregate of a compound of the invention or natural product and one or more solvent molecules formed by solvation, which includes varying degrees of ionic and covalent bonds, such as hydrogen bonds. "Hydrate" is a solvate with water (H2O) molecules as solvent.

[0036] The term "prodrug" refers to a substance that can be converted into a biologically active compound of the present invention or natural product through metabolism in vivo.

[0037] The term "co-crystal" refers to a crystal formed by the active pharmaceutical ingredient (API) and the co-crystal former (CCF) under the action of hydrogen bonds or other non-covalent bonds. Co-crystals are multi-component crystals, including binary co-crystals formed between two neutral solids and multi-component co-crystals formed between neutral solids and salts or solvates.

[0038] The term "carrier" refers to a material that does not cause significant irritation to an organism and does not abrogate the biological activity and properties of the administered compound or natural product.

[0039] The term "excipient" refers to an inert substance added to a pharmaceutical preparation to facilitate administration of a compound or natural product.

[0040] The term "excipient" refers to substances that have been reasonably evaluated for safety and are included in pharmaceutical preparations or cosmetics in addition to active ingredients. In addition to excipients, carriers, and stability improvements, pharmaceutical excipients also have important functions such as solubilization, solubilization, and sustained and controlled release. They are important components that may affect the quality, safety, and effectiveness of drugs. According to their sources, they can be divided into natural products, semi-synthetics, and fully synthetics. According to their functions and uses, they can be divided into: solvents, propellants, solubilizers, cosolvents, emulsifiers, colorants, adhesives, disintegrants, fillers, lubricants, wetting agents, osmotic pressure regulators, stabilizers, glidants, flavoring agents, preservatives, suspending agents, coating materials, fragrances, anti-adhesive agents, antioxidants, chelating agents, penetration enhancers, pH regulators, buffers, plasticizers, surfactants, foaming agents, defoamers, thickeners, inclusion agents, humectants, absorbents, diluents, flocculants and deflocculating agents, filter aids, release retardants, etc. The same pharmaceutical excipient can be used in drug preparations for different administration routes and has different effects and uses.

[0041] The terms "subject", "patient" and "patient" refer to individuals suffering from a disease, disorder or condition, etc., including mammals. Examples of mammals include, but are not limited to, any member of the class Mammalia: humans, non-human primates (e.g., chimpanzees and other apes and monkeys); livestock, such as cattle, horses, sheep, goats, pigs; domestic animals, such as rabbits, dogs and cats; laboratory animals, including rodents, such as rats, mice and guinea pigs, etc.

[0042] The term "treat" and other similar synonyms include alleviating, relieving or ameliorating symptoms of a disease or condition, preventing other symptoms, ameliorating or preventing potential metabolic causes of symptoms, inhibiting a disease or condition, such as arresting the development of a disease or condition, alleviating a disease or condition, causing a disease or condition to improve, relieving symptoms caused by a disease or condition, or stopping symptoms of a disease or condition, and in addition, the term includes the purpose of prevention. The term also includes obtaining a therapeutic effect and / or a preventive effect.

[0043] The technical solution of the present invention is further described in detail below in conjunction with specific embodiments.

[0044] The C57BL / 6 mice used in the examples of the present invention were purchased from the Experimental Animal Center of Guangzhou University of Chinese Medicine, male, 10 weeks old, and weighing about 20 g.

[0045] Oleanolic acid used in the examples of the present invention was purchased from Shanghai Aladdin Biochemical Technology Co., Ltd.; isatis indigo planta was purchased from Shanghai Jizhi Biochemical Technology Co., Ltd.; baicalin was purchased from Shanghai Yuanye Biotechnology Co., Ltd.; other raw materials or reagents were commercially available unless otherwise specified.

[0046] The percentages used in the embodiments of the present invention are all by mass unless otherwise specified.

[0047] Example 1 Effects of bimatoprost, natural products and their combination on proliferation and secretion of vascular endothelial growth factor in mouse hair follicle stem cells

[0048] C57BL / 6 mice were killed by cervical dislocation, and the skin of the tentacles on both sides was cut off. The hair follicles were separated under a microscope, and the hair shaft and hair bulb were removed. Hair follicle stem cells were isolated and cultured by enzyme digestion. Cells with good growth status were taken, digested with 0.05% trypsin-EDTA at 37°C for 10 minutes, centrifuged at 1000 rpm for 5 minutes, and resuspended in keratinocyte complete medium. The cell density was adjusted to 8×10 4 / mL, inoculated in a 96-well plate, 100 μL per well, 37 ° C, 5% CO2, and cultured overnight. The cells were divided into a blank group and a drug-treated group. The blank group was added with a complete culture medium of keratinocytes without the test drug, and the drug-treated groups were added with complete culture medium of keratinocytes containing different test drugs. Among them, the final concentration of bimaprost in the culture medium was 0.1 μM, and the final concentrations of oleanolic acid, isatis glycoside, baicalin, bimaprost + oleanolic acid (molar ratio of 1:100), bimaprost + isatis glycoside (molar ratio of 1:100), and bimaprost + baicalin (molar ratio of 1:100) in the culture medium were all 10 μM. After 24 hours of culture, the proliferation of cells in each group was detected by MTT method, and the level of vascular endothelial growth factor secreted by cells in each group was detected by ELISA method. The results are shown in Tables 1 and 2.

[0049] Table 1 Effects of bimatoprost, natural products and their combination on the proliferation of mouse hair follicle stem cells ( , n=6)

[0050]

[0051] Note: Compared with the blank group, **P<0.01.

[0052] Table 2 Effects of bimatoprost and natural products and their combination on the secretion of vascular endothelial growth factor by mouse hair follicle stem cells ( n=6)

[0053]

[0054] Note: Compared with the blank group, **P<0.01.

[0055] The results showed that bimatoprost can significantly promote the proliferation of mouse hair follicle stem cells, while the natural products oleanolic acid, isatis glycosides and baicalin can significantly promote the secretion of vascular endothelial growth factor by mouse hair follicle stem cells. The two have different mechanisms of promoting hair growth. When bimatoprost is administered in combination with the above natural products, it can simultaneously promote the proliferation of mouse hair follicle stem cells and the secretion of vascular endothelial growth factor. The combination of the two may have a synergistic effect.

[0056] Example 2 Effects of bimatoprost and natural products and their combination on hair growth in mice with dorsal hair loss caused by rosin and paraffin

[0057] After anesthetizing C57BL / 6 mice, a mixture of heated and melted rosin and paraffin (1:1) was evenly applied to the back of the mice, and the dorsal hair was removed after cooling and solidification to establish a dorsal hair loss mouse model. The depilated animals were randomly divided into a solvent group (methanol was applied), an experimental group (test drug was applied), and a negative control group (no drug was applied). The drugs were evenly applied with a cotton swab once a day at a fixed time, and the dosage was 100 μL. Among them, the drugs in the experimental group were all dissolved in methanol. By mass percentage, the concentration of bimatoprost was 0.03%, and the concentrations of oleanolic acid, isatisin, baicalin, bimatoprost + oleanolic acid (molar ratio of 1:100), bimatoprost + isatisin (molar ratio of 1:100), and bimatoprost + baicalin (molar ratio of 1:100) were all 3%. After 28 days of continuous administration, tissues from the same position on the back of the animals in each group were taken to make paraffin tissue sections, and the number of hair follicles was observed and recorded after HE staining. The results are shown in Table 3.

[0058] Table 3 Effects of bimatoprost and natural products and their combination on the number of hair follicles in mice with dorsal hair loss ( n=6)

[0059]

[0060] Note: **P<0.01 compared with the solvent group.

[0061] The results showed that there was no significant difference in the number of hair follicles between the animals in the solvent group and the negative control group, indicating that the solvent (methanol) used in the test drug had no effect on the growth of hair follicles, and the change in the number of hair follicles in the experimental group was caused by the intervention of the test drug. When bimatoprost and the natural products oleanolic acid, isatis glycoside, and baicalin were administered alone, they could effectively promote the growth of the back hair follicles of animals, but the promoting effect of bimatoprost was better than that of natural products. In addition, after the combined administration of bimatoprost and the above-mentioned natural products, the number of hair follicles of the animals was significantly higher than that of bimatoprost or natural products administered alone, indicating that the combined administration of the two can more effectively promote the growth of hair follicles.

[0062] Example 3 Effects of bimatoprost, natural products and their combination on hair growth in mice with chemotherapy-induced alopecia

[0063] After anesthetizing C57BL / 6 mice, a mixture of heated and melted rosin and paraffin (1:1) was evenly applied to the back of the mice, and the back hair was removed after cooling and solidification. After 10 days, a mouse hair loss model caused by chemotherapy drugs was established by a single intraperitoneal injection of cyclophosphamide (150 mg / kg). The animals after modeling were randomly divided into a control group (applied with normal saline) and an experimental group (applied with test drugs), and the drugs were evenly applied with a cotton swab once a day at a fixed time, and the dosage was 100 μL. Among them, the drugs in the experimental group were all dissolved in methanol, and the concentration of bimatoprost was 0.03% by mass percentage, and the concentrations of oleanolic acid, isatis glycoside, baicalin, bimatoprost + oleanolic acid (molar ratio of 1:100), bimatoprost + isatis glycoside (molar ratio of 1:100), and bimatoprost + baicalin (molar ratio of 1:100) were all 3%. After 20 days of continuous administration, tissues at the same position on the back of the animals in each group were taken to make paraffin tissue sections, and the number of hair follicles was observed and recorded after HE staining. The results are shown in Table 4.

[0064] Table 4 Effects of bimatoprost, natural products and their combination on the number of hair follicles in mice with chemotherapy-induced alopecia ( , n=6)

[0065]

[0066] Note: **P<0.01 compared with the control group.

[0067] The results showed that both bimatoprost and natural products could significantly increase the number of hair follicles in mice with chemotherapy-induced hair loss when administered alone, and the effect of combined administration of the two was significantly better than that of bimatoprost or natural products administered alone, indicating that both bimatoprost and natural products can treat chemotherapy-induced hair loss, and the combination of the two has a significant synergistic effect.

[0068] In summary, bimatoprost and natural products (such as oleanolic acid, isatis indigo plant glycosides, baicalin, etc.) are very suitable for combined use as medicines, cosmetics, functional health products, sanitary products, etc., and can be applied to different pathological types of hair loss, especially hair loss caused by chemotherapy in cancer patients, and therefore have very good practicality.

[0069] Unless otherwise defined, the terms used in the present invention have the meanings commonly understood by those skilled in the art.

[0070] The embodiments described in the present invention are for illustrative purposes only and are not intended to limit the scope of protection of the present invention. Those skilled in the art may make various other substitutions, changes and improvements within the scope of the present invention. Therefore, the present invention is not limited to the above embodiments, but is only limited by the claims.

Claims

1. A composition, characterized in that The composition comprises an active component A and an active component B, wherein the active component A is bimatoprost or a physiologically acceptable salt, solvate or prodrug thereof, and the active component B is a natural product or a physiologically acceptable non-covalent derivative thereof.

2. The composition according to claim 1, characterized in that The molar ratio of the active component A to the active component B is 0.1-5:10-300, preferably 1-5:100-300.

3. The composition according to claim 1 or 2, characterized in that The active component B is a natural product or a physiologically acceptable salt, solvate or co-crystal thereof.

4. The composition according to claim 3, characterized in that The natural product is one or more of terpene natural products, indole natural products, flavonoid natural products, anthraquinone natural products, stilbene natural products, and diketone natural products; Preferably, the terpene natural product is oleanolic acid and / or cedrol; and / or The indole natural product is isatis glycoside; and / or The flavonoid natural product is terebinthioside and / or baicalin; and / or The anthraquinone natural product is rhein; and / or The stilbene natural product is diphenylethylene glycoside; and / or The diketone natural product is curcumin.

5. A pharmaceutical preparation, characterized in that The pharmaceutical preparation comprises the composition according to any one of claims 1 to 4 and a pharmaceutically acceptable excipient and / or auxiliary material.

6. A cosmetic, characterized in that: The cosmetic comprises the composition according to any one of claims 1 to 4 and a carrier and / or auxiliary material acceptable in the cosmetics field.

7. The pharmaceutical preparation according to claim 5 or the cosmetic according to claim 6, characterized in that In terms of mass percentage, the content of the active component A is 0.001-2%, preferably 0.005-0.1%.

8. The pharmaceutical preparation according to claim 5 or the cosmetic according to claim 6, characterized in that The pharmaceutical preparation is an eye drop, a tincture, a liniment, a paint, a gel, an emulsion, a microneedle, a patch, a lotion or an aerosol; preferably, the preparation is administered transdermally or intradermally; The cosmetics are preferably hair cosmetics, more preferably shampoo, conditioner, hair essence, hair oil, hair milk, scalp cream, hair gel, hair wax, hair mask, hair dye, hair growth liquid, eyelash care liquid or eyebrow care liquid.

9. Use of the composition according to any one of claims 1 to 4 in the preparation of a medicament or cosmetic for preventing and / or treating alopecia and / or promoting hair growth; or Use of the pharmaceutical preparation according to claim 5 as a drug for preventing and / or treating hair loss diseases and / or for promoting hair growth; or Use of the cosmetic according to claim 6 as a cosmetic for preventing and / or treating hair loss diseases and / or for promoting hair growth.

10. The use according to claim 9, characterized in that The hair loss diseases are hair loss caused by chemotherapy, hair loss caused by radiotherapy, hypoeyelashes, hypobrows, androgenic alopecia, alopecia areata, female pattern hair loss, anagen effluvium or telogen effluvium; preferably, the hair loss diseases are hair loss caused by chemotherapy in cancer patients.

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