Use of clove oil in the manufacture of a hair growth promoting product

Abstract

This invention relates to the field of pharmaceutical technology, specifically to the application of clove oil in the preparation of products that promote hair growth. The clove oil can increase the area of ​​new hair growth; promote hair follicle development, specifically by increasing the ratio of secondary hair follicles to primary hair follicles, thus increasing the number of hair follicles; and promote increased hair shaft length, i.e., increased hair growth length. The clove oil has no toxic side effects and can be safely used to promote hair growth. The clove oil, with the addition of excipients, can be prepared into different dosage forms for the treatment and / or prevention of alopecia and thinning hair, meeting various needs and possessing broad application prospects, significant social significance, and economic value.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical technology, specifically to the application of clove oil in the preparation of products that promote hair growth. Background Technology

[0002] Hair loss is a common clinical skin condition characterized by abnormal hair loss from the scalp. Although it does not endanger a patient's life, it severely impacts their appearance, self-confidence, and even mental health, causing significant psychological distress. The causes of hair loss are diverse, with hormone levels, genetic predisposition, oxidative stress, loss of extracellular matrix proteins in hair follicle cells, medications, and inflammation all playing a dominant or interacting role in the process. Research has found that hair growth is a dynamic process controlled by the hair follicle cycle. It is generally believed that the number of hair follicles at birth is fixed, and the cyclical growth of hair is not the formation of new follicles, but rather the physiological cycle of existing follicles leading to hair replacement. The hair follicle growth cycle generally consists of three phases: the anagen (growth) phase, the catagen (transitional) phase, and the telogen (resting) phase. After follicle formation, its growth strictly follows the cyclical pattern, but factors such as light, temperature, and season can affect the hair cycle. Under the influence of various congenital and acquired factors, as the hair follicle cycle progresses, pathological abnormalities occur during follicle regeneration, ultimately leading to follicle atrophy and hair loss.

[0003] Currently, the main methods for treating hair loss include surgical and non-surgical methods. Surgical methods include hair transplantation, microneedling, and laser therapy, but their application is limited by their high cost. Non-surgical methods mainly involve drug treatment. The FDA has approved two drugs, finasteride and minoxidil, for the treatment of hair loss; however, these drugs have limited efficacy and serious side effects, affecting their application. Therefore, how to safely, effectively, and conveniently intervene in hair loss is an urgent technical problem to be solved.

[0004] Clove oil is a yellow or colorless clear volatile oil obtained by distillation of dried clove buds. It emits a distinctive aromatic odor and oxidizes easily when exposed to air, darkening in color. Eugenol (C 10 H 12 Eugenol (O2) is an aromatic phenolic compound, typically obtained from the natural essential oils of plants in the Lamiaceae, Lauraceae, and Myristaceae families. It is the main component of clove oil, a colorless to pale yellow liquid, slightly soluble in water, and readily soluble in organic solvents. Eugenol possesses various antioxidant, analgesic, antimutagenic, antiplatelet, antiallergic, anti-inflammatory, and antibacterial biological activities. However, no literature currently discloses that clove oil has the effect of preventing or treating hair loss or promoting hair growth.

[0005] The inventors made an unexpected discovery during their research that clove oil has the effect of promoting hair growth, which has important social and economic significance in the development of drugs that promote hair growth. Summary of the Invention

[0006] The primary objective of this invention is to provide the application of clove oil in the preparation of products that promote hair growth.

[0007] A second objective of this invention is to provide the application of clove oil in the preparation of products that promote hair length growth.

[0008] A third objective of this invention is to provide the application of clove oil in the preparation of products that increase hair growth area.

[0009] The fourth objective of this invention is to provide the application of clove oil in the preparation of products that promote hair follicle development.

[0010] The fifth objective of this invention is to provide the application of eugenol in the preparation of products that promote hair growth.

[0011] The sixth objective of this invention is to provide the application of eugenol in the preparation of products that promote hair length growth, increase the area of ​​new hair growth, and promote hair follicle development.

[0012] Preferably, the product is a pharmaceutical and / or cosmetic.

[0013] Preferably, the medicine and / or cosmetic is a hair growth agent and / or a hair loss prevention agent.

[0014] Preferably, the pharmaceuticals and / or cosmetics contain 5% to 10% clove oil by mass, with the remainder being excipients.

[0015] Preferably, the clove oil, when combined with excipients, is prepared into one or more of the following: lotion, bath product, liniment, tincture, oil, cream, ointment, plaster, paste, plaster, patch, coating, film, gel, poultice, dressing, spray, aerosol, implant, emulsion, shampoo, conditioner, suppository, tablet, capsule, pill, injection, and powder.

[0016] The beneficial effects of the present invention are: (1) The present invention provides a new use of clove oil in promoting hair growth. The clove oil can increase the area of ​​new hair growth; promote hair follicle development, specifically by increasing the ratio of secondary hair follicles to primary hair follicles and increasing the number of hair follicles; and promote the increase of hair shaft length, i.e., the increase of hair growth length; (2) The clove oil has no toxic side effects and can be safely used to promote hair growth; (3) The clove oil, with the addition of excipients, can be prepared into different dosage forms for the treatment and / or prevention of alopecia and thinning hair, meeting a variety of needs, with broad application prospects, important social significance and economic value. Attached Figure Description

[0017] Figure 1 Appearance of clove oil preparations

[0018] Note: The left side shows the nanoemulsion carrier, and the right side shows the 10% clove oil nanoemulsion.

[0019] Figure 2 Clove oil's effect on hair growth on the back of mice

[0020] Figure 3 Effects of clove oil on hair length on the back of mice

[0021] Figure 4 H&E staining of mouse back skin

[0022] Figure 5 Number of secondary hair follicles / number of primary hair follicles on the back of a mouse Detailed Implementation

[0023] To better understand the present invention, the following detailed description of the present invention through specific embodiments is provided, but it should not be construed as a limitation of the present invention.

[0024] Unless otherwise specified, all experiments disclosed in this invention employ conventional methods.

[0025] Unless otherwise specified, all drugs involved in this invention are commercially available.

[0026] The clove oil described in this invention is extracted from cloves in the laboratory. The cloves are purchased from the market, and the clove oil is extracted using steam distillation.

[0027] Example 1

[0028] A method for preparing clove oil is as follows:

[0029] Weigh 500g of clove granules and place them in a 10L flask. Add 6L of distilled water and heat under an electric heating mantle. Extract clove oil using steam distillation until no oily substance remains and the solution is clear and transparent. Stop heating when the distillation has continued for 16 hours. Add anhydrous magnesium sulfate to the collected clove oil to absorb the moisture. Store at 4℃. According to the 2020 edition of the Chinese Pharmacopoeia, clove oil is a volatile oil extracted by steam distillation from the dried flower buds of *Eugenia cayophyllata* Thunb., a plant in the Myrtaceae family. The eugenol content (C10H12O2) is 75.0%–88.0%.

[0030] Example 2

[0031] A topical preparation for hair regeneration, the preparation method of which includes the following steps:

[0032] (1) Mix 27.5 parts by weight of Tween 80 and 18.5 parts by weight of anhydrous ethanol on a magnetic stirrer.

[0033] (2) Add 5 parts by weight of isopropyl myristate and continue stirring;

[0034] (3) Slowly add 39 parts by weight of distilled water while stirring;

[0035] (4) Add 10 parts by weight of clove oil, and then continue stirring for 30 minutes to obtain 10% clove oil nanoemulsion.

[0036] Example 3

[0037] A topical preparation for hair regeneration, the preparation method of which includes the following steps:

[0038] (1) Mix 27.5 parts by weight of Tween 80 and 18.5 parts by weight of glycerol on a magnetic stirrer.

[0039] (2) Add 5 parts by weight of peanut oil and continue stirring;

[0040] (3) Slowly add 39 parts by weight of distilled water while stirring;

[0041] (4) Add 10 parts by weight of clove oil, and then continue stirring for 30 minutes to obtain 10% clove oil nanoemulsion.

[0042] Example 4

[0043] A topical preparation for hair regeneration, the preparation method of which includes the following steps:

[0044] (1) Mix 20 parts by weight of Tween 80, 5 parts by weight of Tween 20, 3.5 parts by weight of anhydrous ethanol and 15 parts by weight of glycerol on a magnetic stirrer.

[0045] (2) Add 1 part by weight of vitamin E oil and 10 parts by weight of corn oil, and continue stirring;

[0046] (3) Slowly add 35.5 parts by weight of distilled water while stirring;

[0047] (4) Add 10 parts by weight of clove oil, and then continue stirring for 30 minutes to obtain 10% clove oil nanoemulsion.

[0048] Example 5: Performance Evaluation of Topical Preparations for Hair Regeneration Using Clove Oil

[0049] Nanoemulsions are clear, transparent, optically isotropic, and thermodynamically and kinetically stable dispersion systems with droplet sizes less than 100 nm. To prepare pharmaceutical-grade clove oil nanoemulsions, the type of clove oil nanoemulsion was determined using a staining method; the microstructure and droplet size of the clove oil nanoemulsions were detected using transmission electron microscopy; and the stability was assessed using centrifugation, isothermal acceleration, and room-temperature observation.

[0050] If left at room temperature for 12 months, such as Figure 1 Example 4 remained clear, transparent, and homogeneous. The pH value remained essentially constant at 7.0 with no significant change. High-performance liquid chromatography (HPLC) analysis showed almost no change in eugenol content after one year of storage. The blue nanoemulsion diffused faster than the red nanoemulsion, confirming that the system was an O / W type nanoemulsion. Microscopic morphology observation revealed that the nanoemulsion droplets were spherical with an average droplet size of 40 nm, with 90% of the droplets ranging from 30 to 50 nm in size. The droplets were uniformly distributed and of consistent size, indicating good nanoemulsion dispersion.

[0051] The skin irritation test results of clove oil nanoemulsion showed no difference in skin irritation between mice with and without damaged or intact skin; neither erythema nor edema occurred. Therefore, it is concluded that the nanoemulsion did not cause any irritation to mouse skin. Thus, nanoemulsions can be used as carriers for topical medications and applied in practice to exert their effective carrier function.

[0052] Example 6: Effect of clove oil nanoemulsion on hair growth in mice

[0053] (1) Experimental methods and materials

[0054] Experimental Design: Twenty-four SPF-grade Babl / c mice, 6 weeks old, weighing 18-22g, were used. Mice were placed in a 12 / 12h light / dark cycle environment at 23±2℃ and 50±10% humidity. During the acclimatization period, they were given free access to food and water. After one week of acclimatization, the 24 mice were randomly divided into four groups of six: a control group (no treatment), a group receiving the 10% clove oil nanoemulsion prepared in Example 4, a group receiving the 5% clove oil nanoemulsion diluted with distilled water as described in Example 4, and a nanoemulsion carrier control group. After the acclimatization period, the hair on the backs of the mice was removed and depilated with hair removal cream. Except for the control group, clove oil nanoemulsion and nanoemulsion carrier were applied to the backs of the mice in each group, respectively.

[0055] Measurement indicators and methods: Hair growth was photographed and recorded on the day of application (day 0) and on days 3, 6, 9, 11, 13, and 15. The growth area was measured. On day 15 of hair growth, hair was shaved from the experimental area on the back of each mouse and weighed. Five hairs were randomly selected and their lengths were measured. After the mice were euthanized, approximately 1 cm from the center of the experimental area on their backs was collected.2 Skin samples were fixed in 4% paraformaldehyde fixative for at least 24 hours for HE staining. Images of the sections were acquired using a BA210 Digital trinocular microscopy system (manufactured by Macody Industrial Group Co., Ltd.). For each section, the entire tissue was first observed at low magnification, and then 100x images were acquired for the selected area for counting. The number of primary and secondary hair follicles in each field of view was counted, and the density and follicle ratio (S / P) of primary and secondary hair follicles were calculated. Because skin tissue contracts, all skin data in this experiment are corrected for skin contraction.

[0056] Hair follicle density = number of hair follicles per field of view / field of view area (1.36285275 square millimeters)

[0057] S / P value = Secondary hair follicle density / Primary hair follicle density

[0058] (2) Experimental Results

[0059] Depend on Figure 2 and Figure 3 It can be seen that after 9 days of administration, the back hair of mice in each group grew to varying degrees, with the 10% clove oil group showing the largest area of ​​new hair growth on the back. The area of ​​new hair growth on the back skin of mice treated with different concentrations of clove oil increased with increasing clove oil concentration. After 11 days of administration, the area of ​​new hair growth on the skin of mice in all clove oil groups increased, with localized short hair shafts appearing, and within the concentration range of this experiment, a clove oil concentration-dependent trend was observed. The control group mice showed no new hair growth over a large area of ​​their back skin. After 13 days of administration, hair shafts appeared in all groups of mice. Compared with the blank control group, the area of ​​new hair growth and the length of hair shafts on the back skin of mice in the clove oil-treated group increased. After 14 days of administration, compared with the blank control group and the nanoemulsion carrier group, the area of ​​new hair growth and the length of hair shafts on the back skin of mice in the clove oil-treated group increased, and the back hair of the mice showed visibly dense growth. The area of ​​new hair growth on the back skin of mice in the blank control group increased compared to before, but some parts of the back skin remained pink, and only a small amount of hair grew. After 15 days of drug administration, except for the blank control group and the nanoemulsion carrier group, the hair growth on the backs of mice in all other groups was complete and dense, with only a small amount of hair growing slowly at the junction of the head and back in the hair-removed treatment group. Comparison of hair shaft length among the groups revealed that the hair shaft length of the clove oil treatment group was significantly longer (P<0.001) than that of the blank control group and also significantly longer (P<0.001) than that of the nanoemulsion carrier treatment group. However, within the clove oil treatment group, the hair shaft lengths of the mice in the 10% clove oil and 5% clove oil treatment groups were almost the same, with no significant difference.

[0060] Primary hair follicles develop and differentiate early, forming coarse hair, while secondary hair follicles differentiate later, forming vellus hair. The ratio of secondary hair follicle density to primary hair follicle density is an important indicator reflecting hair growth performance. To further confirm the hair growth-promoting effect of clove oil through changes in hair follicle development, we performed histological sections and H&E staining on the dorsal skin of mice in different treatment groups 15 days after hair removal treatment, and observed morphological changes under a microscope, such as... Figure 4 . Figure 5 The results showed that after 15 days of administration, the number of hair follicles in the skin of mice in the clove oil group was significantly increased compared with the blank control group and the carrier group. The ratio of secondary hair follicles to primary hair follicles in the clove oil group was significantly higher (P<0.05) than that in the blank control group and the carrier group.

[0061] The experimental group received continuous application of the drug for 15 days. No allergic reactions, peeling, or wrinkling were observed on the backs of the mice. Skin color, texture, and other aspects were not significantly different from the blank control group and the carrier control group. Observations showed that the mice's physiological condition was normal in all aspects. Within the drug concentration range (10%–1% mass concentration), it is non-irritating, non-toxic, and causes no allergic reactions to the skin; it is safe to use and has no toxic side effects. Therefore, clove oil, as a highly effective hair growth promoter, has significant application value.

[0062] In summary, this invention provides a novel use of clove oil in promoting hair growth. The clove oil can increase the area of ​​new hair growth; promote hair follicle development, specifically by increasing the ratio of secondary hair follicles to primary hair follicles, thus increasing the number of hair follicles; and promote increased hair shaft length, i.e., increased hair growth length. The clove oil has no toxic side effects and can be safely used to promote hair growth. This invention also provides a novel use of eugenol in promoting hair growth. The clove oil and eugenol, with the addition of excipients, can be prepared into different dosage forms for the treatment and / or prevention of alopecia and thinning hair, meeting various needs and possessing broad application prospects, significant social and economic value.

Claims

1. Application of clove oil as the sole active ingredient in the preparation of products that promote hair growth.

2. The application as described in claim 1, characterized in that, The products mentioned are pharmaceuticals and / or cosmetics.

3. The application as described in claim 2, characterized in that, The medicines and / or cosmetics mentioned are hair growth agents and / or hair loss prevention agents.

4. The application as described in claim 3, characterized in that, The pharmaceuticals and / or cosmetics mentioned herein contain 5% to 10% clove oil by mass, with the remainder being excipients.

5. The application as described in claim 4, characterized in that, The clove oil is added to excipients to prepare an emulsion.

6. The application as described in claim 5, characterized in that, The emulsion is prepared into a lotion or bath solution by adding excipients.

7. The application as described in claim 6, characterized in that, The cleaning agent mentioned is specifically shampoo or conditioner.

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