Composition for inhibiting alopecia and / or promoting hair regeneration

Abstract

The invention belongs to the field of nutrition and health, and particularly relates to a composition for inhibiting alopecia and / or promoting hair regeneration. Through wide screening and combination analysis, it is found that the composition of the South African drunken eggplant, the cartilage extract, the vitamin B2, the vitamin B6 and the biotin has the remarkable effects of inhibiting alopecia, prolonging the proportion of hair in the growing period, promoting activation of hair follicles and driving recovery of the hair regeneration capacity, and the composition is safe and reliable and has a good application prospect. And a new thought is provided for improving hair health.

Description

Technical Field

[0001] The invention belongs to the field of nutrition and health, and in particular relates to a composition for inhibiting hair loss and / or promoting hair regeneration. Background Art

[0002] As people's pace of life continues to accelerate, life and work pressures increase, and hair loss has become a common problem faced by the social population. In particular, the phenomenon of hair loss among young people is more prominent, and has become an important factor affecting young people's participation in social activities. Hair loss is divided into pathological hair loss and physiological hair loss. Pathological hair loss refers to hair loss caused by the stimulation of the disease or the influence of chemotherapy drugs during the disease or treatment stage of the disease. Physiological hair loss is a normal physiological metabolic activity of adults. The growth cycle of normal hair generally includes three stages: growth phase, regression phase and resting phase. Most hair is in the growth phase, then enters a shorter regression phase, and finally enters a resting phase of about 12 weeks. The hair in the resting phase, then the hair grows out of the hair follicle again and enters the growth phase, such a new cycle process. However, due to the influence of factors such as scalp aging, pressure, hormone levels, and local microcirculation, the hair growth cycle process is disordered, the hair resting phase becomes longer, the growth phase becomes shorter, some hair enters the resting phase early, the hair follicles are damaged, the hair follicles are miniaturized, and the hair cannot grow again. Common forms of hair loss include telogen effluvium, androgenic alopecia (seborrheic alopecia), alopecia areata, etc.

[0003] At present, the agents for hair loss prevention / regeneration are mainly cosmetics, and their product type is external preparations. External preparations are easy to use, but most of them can only act on the epithelial cells of the epidermis, and it is difficult to regulate the growth of hair follicles on the head from the inside out. In addition to minoxidil and finasteride, current anti-hair loss products also use a variety of plant active ingredients such as ginseng extract, ginger extract, Platycladus orientalis leaf extract, Polygonum multiflorum extract, etc. to enhance or play their role in improving scalp health, activating cells, and promoting hair growth. For example, CN201811502797.X uses 9 kinds of traditional Chinese medicine ingredients to promote hair growth, but in terms of specific efficacy, inhibiting hair loss and / or promoting hair regeneration still requires further research and exploration. Summary of the invention

[0004] After extensive screening and research, the present invention has developed a composition for inhibiting hair loss and / or promoting hair regeneration, which can effectively inhibit the occurrence of hair loss, prolong the proportion of hair in the growth phase, and promote the activation of hair follicles, driving the recovery of hair regeneration ability. Specifically, the present invention provides a composition for inhibiting hair loss and / or promoting hair regeneration, the composition comprising: ashwagandha extract, cartilage extract, vitamin B2, vitamin B6 and biotin;

[0005] Ashwagandha (Withania somnifera), also known as Indian ginseng, is a traditional Indian Ayurvedic herb widely used to promote sleep and regulate immunity. Studies have also shown that it has the effects of lowering blood lipids, lowering blood sugar and protecting nerves. According to research, the ashwagandha extract contains active ingredients such as withanolides, alkaloids, and steroids. The ashwagandha described in the present invention is made from the leaves and roots of ashwagandha, extracted by water, concentrated, and spray-dried, wherein the content of withanolides is ≥5%;

[0006] In the present invention, the cartilage extract is one or more of shark cartilage extract, skate cartilage extract, chicken cartilage extract, pig cartilage extract or bovine cartilage extract, and these cartilage extracts contain not only protein but also a variety of mucopolysaccharides, proteoglycans, glycosaminoglycans, etc. Preferably, the cartilage extract is chicken cartilage extract, wherein the content of glycosaminoglycans is ≥15%, and the content of protein is ≥60%.

[0007] In one embodiment, the present invention provides a composition for inhibiting hair loss and / or promoting hair regeneration, comprising: 15-40 parts of ashwagandha extract, 30-70 parts of cartilage extract, 0.1-2 parts of vitamin B2, 0.1-1 part of vitamin B6, and 0.04-0.5 parts of biotin.

[0008] In one embodiment, the invention provides a composition for inhibiting hair loss and / or promoting hair regeneration, the composition comprising: 25 parts of ashwagandha extract, 50 parts of cartilage extract, 1.1 parts of vitamin B2, 0.7 parts of vitamin B6, and 0.3 parts of biotin.

[0009] In one aspect of the present invention, the composition of the present invention can be used to prepare medicines and functional foods for inhibiting hair loss and / or promoting hair regeneration. That is, the composition of the present invention can be further combined with acceptable adjuvants or additives in medicines / foods to prepare various oral dosage forms. The dosage forms include tablets, capsules (hard capsules, soft capsules), powders, soft candies, oral liquids, pills, drops, etc. In the present invention, acceptable adjuvants that can be used in medicines / foods include one or more of carriers, solvents, excipients, buffers, lubricants, sweeteners, and edible flavors. These excipients include colloidal silicon dioxide, sugars and sugar alcohols (sucrose, glucose, lactose, sorbitol, erythritol), starch and its derivatives, such as starch, modified starch, pregelatinized starch, dextrin; cellulose and its derivatives, such as microcrystalline cellulose, sodium carboxymethyl cellulose, hydroxypropyl cellulose, ethyl cellulose, cellulose acetate; gelatin, gum arabic, gellan gum, carrageenan, xanthan gum, sodium alginate, magnesium stearate, polyvinyl pyrrolidone, cross-linked polyvinylpyrrolidone; oils such as soybean oil, peanut oil, MCT oil, olive oil, corn oil, algae oil, glycerin.

[0010] It should be understood that in the present invention, the composition of the present invention can prolong the growth phase of hair, inhibit hair from entering the regression phase, and play an inhibitory effect on hair loss, that is, it is used for the treatment and prevention of hair loss, and can also promote hair regeneration by activating hair follicles.

[0011] Beneficial Effects

[0012] (1) The composition of the present invention adopts a food-derived natural substance formula, avoiding the use of androgen inhibitors such as minoxidil and finasteride, which may cause endocrine disruption and metabolic effects, as well as other undesirable side effects such as skin irritation, rash, sexual dysfunction, allergies, etc.

[0013] (2) The present invention unexpectedly discovered that the combination of specific component contents of ashwagandha and cartilage extract plays a synergistic role in preventing hair loss and promoting hair growth. The composition of the present invention has a simple formula and clear efficacy, avoiding the difficulty of drug compatibility caused by excessive use of different types of natural products and the problem of difficulty in determining the effective substances, while also improving the compliance of taking. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 : Comparison of hair follicle activation and growth after the subjects took the composition of the present invention (Example 2), wherein A is the hair root condition photographed on the 2nd day after taking the composition, and B is the hair root condition photographed at the same site on the 86th day after taking the composition. It can be seen that new hair has grown in some hair follicle sites (boxed sites).

[0015] Figure 2 : Comparison of hair follicle activation and growth after the subjects took control group 4, where A is the hair root condition photographed on the 2nd day of taking the medicine, and B is the hair root condition photographed at the same location on the 86th day of taking the medicine. It can be seen that new hair has grown in a small number of hair follicles (boxed area).

[0016] Figure 3 : Comparison of hair follicle activation and growth after subjects took the placebo group, where A is the hair root condition photographed on the 2nd day of taking the medicine, and B is the hair root condition photographed at the same location on the 86th day of taking the medicine. No obvious new hair growth was found.

[0017] Figure 4 : Shows the comparison of the reduction in average hair loss counts of each group. In the comparison between the Example group and the placebo 4, # indicates P<0.05, ## indicates P<0.01, and ### indicates P<0.001.

[0018] Figure 5: Shows the comparison between the embodiment combination and comparative example 3, * indicates P<0.05, ** indicates P<0.01, *** indicates P<0.001.

[0019] Figure 6 : Shows the comparison between the embodiment combination and comparative example 4, * indicates P<0.05, ** indicates P<0.01, *** indicates P<0.001. DETAILED DESCRIPTION

[0020] The embodiments of the present invention will be described in detail below in conjunction with the examples, but those skilled in the art will appreciate that the following examples are only used to illustrate the present invention and should not be considered to limit the scope of the present invention. If no specific conditions are specified in the examples, they are carried out according to normal conditions or the conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be obtained commercially.

[0021] Reagents: Ashwagandha extract (withanolide content ≥5%), vitamin B2, vitamin B6, biotin, purchased from commercial products; cartilage extract (glycosaminoglycan content ≥15%, protein content ≥60%), provided by By-Health Co., Ltd.

[0022] Embodiment 1:

[0023] According to the weight ratio, 15 parts of ashwagandha, 70 parts of cartilage extract, 0.1 parts of vitamin B2, 1 part of vitamin B6 and 0.06 parts of biotin are mixed with lactose, starch, microcrystalline cellulose and magnesium stearate as auxiliary materials to prepare tablets by tableting and coating.

[0024] Embodiment 2:

[0025] According to the weight ratio, 25 parts of ashwagandha, 50 parts of cartilage extract, 0.25 parts of vitamin B2, 0.6 parts of vitamin B6 and 0.25 parts of biotin are mixed with lactose, starch, microcrystalline cellulose and magnesium stearate as auxiliary materials to prepare tablets by tableting and coating.

[0026] Embodiment 3:

[0027] According to the weight ratio, 40 parts of ashwagandha, 30 parts of cartilage extract, 2 parts of vitamin B2, 0.5 parts of vitamin B6 and 0.1 parts of biotin are mixed with lactose, starch and microcrystalline cellulose as auxiliary materials to prepare tablets by tableting and coating.

[0028] Comparison Group 1:

[0029] According to the weight ratio, 50 parts of cartilage extract, 0.25 parts of vitamin B2, 0.6 parts of vitamin B6 and 0.25 parts of biotin are mixed with lactose, starch and microcrystalline cellulose as auxiliary materials to prepare tablets by tableting and coating.

[0030] Comparison Group 2:

[0031] According to the weight ratio, 25 parts of ashwagandha, 0.25 parts of vitamin B2, 0.6 parts of vitamin B6 and 0.25 parts of biotin are mixed with lactose, starch and microcrystalline cellulose as auxiliary materials to prepare tablets by tableting and coating.

[0032] Comparison group 3:

[0033] According to the weight ratio, 25 parts of ashwagandha, 50 parts of fish skin collagen peptide, 0.25 parts of vitamin B2, 0.6 parts of vitamin B6 and 0.25 parts of biotin are mixed with lactose, starch and microcrystalline cellulose as auxiliary materials to prepare tablets by tableting and coating.

[0034] Comparison group 4:

[0035] According to the weight ratio, 25 parts of ashwagandha, 50 parts of water-soluble keratin, 0.25 parts of vitamin B2, 0.6 parts of vitamin B6 and 0.25 parts of biotin are mixed with lactose, starch and microcrystalline cellulose as auxiliary materials to prepare tablets by tableting and coating.

[0036] Placebo Group:

[0037] According to a certain weight ratio, lactose, starch and microcrystalline cellulose are mixed and granulated, and then compressed and coated to prepare tablets.

[0038] 2. Anti-hair loss and hair growth efficacy test

[0039] 2.1 Selection of subjects

[0040] 2.1.1 Number of selected subjects and grouping

[0041] Eligible subjects were selected according to the inclusion and exclusion criteria and divided into example product groups 1-3, comparative product groups 1-4 and a placebo product group according to a random table. A total of 240 subjects were included and grouped according to the inclusion criteria and grouping requirements, with 30 subjects in each group.

[0042] 2.1.2 Inclusion criteria

[0043] (1) 18 to 60 years old, healthy men and women;

[0044] (2) Hair length is between 5 and 40 cm;

[0045] (3) Having problems with excessive hair loss and mild hair thinning, and the number of hair loss counts according to the 60-times combing method is greater than 20; the 60-times combing method is as follows: ① The subject cannot wash his hair within 48±4 hours before each visit, and cannot comb his hair on the morning of the visit; ② After arriving at the test institution and acclimatizing to the environment each time, the same trained technician uses a comb of the same specifications (in accordance with the requirements of the cosmetic anti-hair loss efficacy test method) to comb the hair 60 times at a constant speed (30 times on each side) in the order from left front to left back and right front to right back; ③ Collect the fallen hair and count it.

[0046] (4) Those who have not undergone any special hair treatments such as hair dyeing, perming, styling, etc. in the past month;

[0047] (5) Those who can understand the trial process, voluntarily participate in the trial and sign the written informed consent.

[0048] (6) Willing to not take oral products with the same efficacy as the test product, such as those for preventing hair loss, in addition to the test product or control product during the trial period, and to maintain the original skin care habits for daily skin care, without changing brands or using new products;

[0049] 2.1.3 Exclusion criteria

[0050] (1) Pregnant or breastfeeding women, or those who are planning to get pregnant in the near future;

[0051] (2) Patients with severe androgenic alopecia, alopecia areata, inflammatory cicatricial alopecia or other scalp / hair diseases;

[0052] (3) Those who suffer from mental or psychological diseases; or those who have long-term sleep or emotion control disorders;

[0053] (4) Those who have used cosmetics with anti-hair loss effects or other products with such effects or hair growth effects in the past three months;

[0054] (5) Those who have taken or topically applied any medication that affects hair growth in the past 6 months;

[0055] (6) Those who have received hair transplantation treatment;

[0056] (7) People with curly hair;

[0057] (8) Those with highly sensitive constitutions;

[0058] (9) Participated in other clinical trials in the past 2 months;

[0059] (10) Other patients deemed unsuitable for trial participation by clinical assessment.

[0060] 2.1.4 Subject Restrictions

[0061] (1) Subjects should not wash their hair within 48±4 hours before screening and each visit during the trial period, and the time before each visit should be basically the same. Subjects should not comb their hair on their own on the day of the visit.

[0062] (2) No haircut within 2 weeks before each visit assessment during the trial;

[0063] (3) During the trial period, patients are not allowed to take any hair care or hairdressing treatments, nor receive any hair loss prevention or hair growth treatments;

[0064] (4) During the trial, you need to maintain your original lifestyle and avoid emotional fluctuations

[0065] 2.1.5 How to use:

[0066] The staff will distribute the example products, comparative products, and placebo group products according to the random table, and guide the subjects on the use of the products according to the instructions to ensure that the subjects use the test products correctly during the trial period. The test products will be taken for at least 12 weeks, and the subjects will be required to record the use of the products and any discomfort and adverse reactions during the use.

[0067] 2.1.6 Test of hair follicle number and other indicators

[0068] A hair-cutting area of ​​at least 1.5 cm × 1.5 cm (temporal side of the top of the head) is fixed on the subject's head. During each visit, the hair-cutting area is ensured to be consistent and the hair is cut to a residual length of no more than 1 mm. During the image acquisition process, the operator needs to put the subject in a comfortable position and place the dermatoscope in the center of the hair-cutting area to capture local hair images. During the shooting, the dermatoscope lens is completely in contact with the scalp and kept vertical, and the clarity of the captured image is checked.

[0069] The basic hair values ​​of the selected subjects were evaluated before using the product, including dermoscopic images (for the percentage of hair in the growth phase and the percentage of hair in the resting phase), hair loss counts (60 combing method), changes in the number of active hair follicles, etc., and the records were kept. The relevant tests and evaluation analyses were conducted three times at week 0 (W0), week 6 (W6), and week 12 (W12) of product use. The test methods for the number of hair loss and growth phase hair were based on Chapter 8 Human Efficacy Evaluation Test Methods 6 "Test Methods for Anti-Hair Loss Efficacy of Cosmetics" of the "Technical Specifications for Safety of Cosmetics" (2015 edition).

[0070] Table 1 Related test indicators, equipment and test conditions

[0071]

[0072] 2.1.6.1 Test results:

[0073] (1) See Table 2 and Figure 4 In terms of the amount of hair loss, Examples 1-3 showed significant improvement compared with the placebo group (P<0.001), and the Example group showed a partial effect of hair loss improvement in the 6th week. The comparative group 1 and the comparative group 2 showed no obvious effect compared with the placebo group, and there was no significant difference. The comparative group 3 and the comparative group 4 also had a partial effect, and there was a significant difference compared with the placebo group (P<0.05). Figure 5-Figure 6 , analyzing the differences between the combination of the present invention and comparison group 3 and comparison group 4, it was found that the combination of the present invention also had significant differences compared with comparison group 3 and comparison group 4 (P<0.01). According to the average amount of hair loss, the Cobly formula was used to calculate the synergy, and the expected value of synergy was E=5.2+5.6-(5.2×5.6) / 100=10.51, while the test value of the combination of Example 2 was 17.06, which was much larger than the expected value. It can be seen that the combination of the present invention has achieved the technical effect of synergistic enhancement. Previous studies have shown that collagen peptides and hydrolyzed keratin have the effect of improving hair loss, and the relevant effects were further confirmed during the testing process of the present invention. However, the combination of the present invention is significantly improved compared with the combination of ashwagandha with collagen peptides and hydrolyzed keratin, which also reflects the excellent and unexpected efficacy of the combination of the present invention.

[0074] Table 2: Hair loss counts in different weeks

[0075]

[0076] (3) Referring to Table 3, the combination of the present invention can significantly reduce the number of hairs in the resting phase, that is, the combination of the present invention can inhibit the hairs in the growth phase from entering the resting phase and prolong the growth time of the hairs. In terms of the rate of change of hairs in the growth phase and the average activated hair follicles, there are significant differences between the embodiment combination and the control group compared with the placebo group, and there is a significant difference between the embodiment combination and control group 4, which also means that the significance is more prominent compared with other control groups. In terms of the rate of change of hairs in the resting phase, there are significant differences between the present invention and control group 4 compared with the placebo group, and there are also significant differences between the embodiment 2 of the present invention combination and control group 4. Most of the hairs on the human body are in the growth phase, so the difference of only about 1% in the growth phase hairs between the groups actually represents that a large number of hairs are maintained in the growth phase. The present invention also tested and analyzed the number of hair follicles in the activated state per unit area. There is also a significant difference between the number of active hair follicles of the combination of the present invention and the control group and the placebo group, indicating that the combination of the present invention can not only prolong the growth phase of the hair and inhibit hair loss, but also activate the hair follicles, promote hair regeneration and enter the growth phase. See Figure 1-Figure 3It can be observed that the composition of the present invention can significantly activate hair follicles and promote hair regeneration after use, which is better than the control combination, while the hair follicles of the placebo group have basically no change.

[0077] Table 3: Comparison of the changes in the resting and growing phases of hair at week 12 and week 0, as well as the changes in the number of active hair follicles

[0078]

[0079] Among them, "#" indicates significant difference compared with control group 4 (p<0.05), "##" p<0.01, and "*" indicates significant difference compared with placebo (p<0.05).

[0080] The above-mentioned embodiments only express several implementation methods of the present invention, and the descriptions thereof are relatively specific and detailed, but they cannot be understood as limiting the scope of the invention patent. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A composition for inhibiting hair loss and / or promoting hair regeneration, characterized in that: The composition includes ashwagandha extract, cartilage extract, vitamin B2, vitamin B6 and biotin.

2. The composition according to claim 1, characterized in that The composition comprises 15-40 parts of ashwagandha extract, 30-70 parts of cartilage extract, 0.1-2 parts of vitamin B2, 0.1-1 parts of vitamin B6 and 0.04-0.5 parts of biotin.

3. The composition according to claim 1, characterized in that The ashwagandha extract comprises 25 parts, cartilage extract comprises 50 parts, vitamin B2 comprises 1.1 parts, vitamin B6 comprises 0.7 parts, and biotin comprises 0.3 parts.

4. The composition according to any one of claims 1 to 3, characterized in that The ashwagandha extract is prepared by taking the leaves and roots of ashwagandha as raw materials, through water extraction, concentration and spray drying, wherein the content of withanolide is ≥5%.

5. The composition according to any one of claims 1 to 3, characterized in that The cartilage extract is one or more of shark cartilage extract, ray cartilage extract, pig cartilage extract, bovine cartilage extract and chicken cartilage extract.

6. The composition according to claim 5, characterized in that The cartilage extract is a chicken cartilage extract, wherein the glycosaminoglycan content is ≥15% and the protein content is ≥60%.

7. Use of the composition according to any one of claims 1 to 6 in the preparation of medicines or functional foods for inhibiting hair loss and / or promoting hair regeneration.

8. The use according to claim 7, characterized in that: The medicine or functional food also contains auxiliary materials or additives acceptable to medicines and foods.

9. The use according to claim 7, characterized in that: The dosage form of the medicine or functional food is tablets, hard capsules, soft capsules, powders, soft candies, oral liquids, pills, and drops.

Images