Traditional Chinese medicine composition for preventing hair loss and growing hair and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for preventing hair loss and promoting hair growth and application thereof, and relates to the technical field of hair loss prevention and hair growth, the traditional Chinese medicine composition is composed of sesame flower, cockscomb, magnolia flower, lithospermum, fleece-flower root, prepared rehmannia root, notopterygium root, radix angelicae pubescentis, ruddle and periostracum cicada; in-vitro experiments show that the traditional Chinese medicine composition can promote proliferation of human dermal papilla cells HDPC, relieve the damage degree of HDPC and induce cycle transformation of hair follicles, so that the effect of promoting hair growth is achieved; animal experiments show that the traditional Chinese medicine composition can significantly increase the number of hair follicles and the thickness of skin and dermis fat of mice, reduce the levels of mouse serum IL-2, TNF-alpha and TGF-beta1 and reduce the levels of testosterone, dihydrotestosterone and estradiol in mouse skin tissue, so that hair follicle fibrosis is inhibited, the growth period of hair follicles is accelerated, the growth period is prolonged, the hair loss phenomenon is improved, and the hair loss rate is increased. The hair growth is promoted.

Description

Technical Field

[0001] The present invention relates to the technical field of anti - hair - loss and hair - growth promotion, and particularly relates to a traditional Chinese medicine composition for anti - hair - loss and hair - growth promotion and its application. Background Art

[0002] Hair loss is a common and frequently - occurring skin disease with the main clinical manifestations of abnormal excessive hair loss and sparse hair. Androgenetic alopecia and alopecia areata are relatively common, which is one of the common clinical diseases in modern society. Although it is not a serious disease threatening human life and health, it brings great mental pressure and psychological burden to patients. According to epidemiological investigations, the proportion of the global hair - loss population reaches 2%, and the hair - loss rates of men and women in China are 21.3% and 6.0% respectively, among which the proportion of men with hair loss before the age of 30 is as high as 84%. Modern medicine believes that multiple pathogenic factors such as genetics, autoimmunity, mental psychology, endocrine, cytokines, and trace elements abnormally regulate the hair - growth cycle, making hair follicles miniaturize, thus inducing hair loss. In the treatment of hair loss, the commonly used drugs in clinical practice are minoxidil and finasteride. These two drugs are prone to recurrence after discontinuation and can also cause adverse reactions such as skin irritation, scalp itching, hirsutism on the face and hands, dizziness, anorexia, and tachycardia.

[0003] Traditional Chinese medicine refers to hair loss as "oily scalp wind", "moth - eaten tinea of the hair", etc. It is believed that pathogenic factors such as blood stasis, damp - heat, heat pathogen, and exogenous pathogens cause deficiency of zang - fu organs, resulting in deficiency of essence and blood, a mixture of deficiency and excess, with deficiency in origin and excess in superficiality, and it is difficult to cure. Eventually, the hair loses nourishment and falls out. The treatment of hair loss in traditional Chinese medicine is mainly related to tonifying the liver and kidney and "blood". Among them, "blood" includes promoting blood circulation, nourishing blood, cooling blood, and enriching blood, and the corresponding treatment methods are removing stasis, replenishing qi, expelling wind, and strengthening the spleen respectively. The microscopic manifestations of hair loss caused by causes such as liver - kidney deficiency, liver - qi stagnation and blood stasis, internal accumulation of damp - heat, and blood - heat and wind - dryness are that the living environment of hair follicle cells is damaged, the functions of hair follicle cells are disordered, and the metabolic products of cell reactivity or dead cells themselves will become "deficiency of healthy qi" or "stagnation of qi and blood", etc. And traditional Chinese medicine can regulate at the microscopic molecular level by affecting the expression of inflammatory mediators, inhibiting apoptosis, regulating gene expression, regulating immune function, etc., control the occurrence and development of hair - loss lesions, achieve a state of internal coordination and balance between yin and yang, thereby reducing hair follicle damage, and finally realizing anti - hair - loss and hair - growth promotion. However, at present, the research on traditional Chinese medicine for anti - hair - loss and hair - growth promotion is mostly about single - herb extracts and active monomer components of traditional Chinese medicine, and there are few traditional Chinese medicine compound formulas. Therefore, it is particularly necessary to develop a traditional Chinese medicine compound formula with the effect of anti - hair - loss and hair - growth promotion, and it has important practical significance. Summary of the Invention

[0004] (1) Technical Problems to be Solved

[0005] In view of the deficiencies of the prior art, the present invention provides a traditional Chinese medicine composition for anti - hair - loss and hair - growth promotion and its application.

[0006] (2) Technical Solutions

[0007] To achieve the above object, the present invention is realized by the following technical solutions:

[0008] The present invention provides a traditional Chinese medicine composition for preventing hair loss and promoting hair growth. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 18 - 43 parts of sesame flower, 20 - 40 parts of cockscomb flower, 15 - 45 parts of magnolia flower, 15 - 45 parts of lithospermum root, 20 - 40 parts of fleece-flower root, 8 - 23 parts of prepared rehmannia root, 5 - 20 parts of notopterygium root, 5 - 20 parts of pubescent angelica root, 15 - 45 parts of hematite, and 5 - 25 parts of cicada slough.

[0009] Further, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 20 - 40 parts of sesame flower, 22 - 35 parts of cockscomb flower, 20 - 40 parts of magnolia flower, 20 - 40 parts of lithospermum root, 22 - 35 parts of fleece-flower root, 10 - 18 parts of prepared rehmannia root, 8 - 16 parts of notopterygium root, 8 - 16 parts of pubescent angelica root, 20 - 40 parts of hematite, and 8 - 16 parts of cicada slough.

[0010] Further, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 30 parts of sesame flower, 30 parts of cockscomb flower, 30 parts of magnolia flower, 30 parts of lithospermum root, 30 parts of fleece-flower root, 15 parts of prepared rehmannia root, 10 parts of notopterygium root, 10 parts of pubescent angelica root, 30 parts of hematite, and 10 parts of cicada slough.

[0011] The present invention provides a preparation method of the traditional Chinese medicine composition for preventing hair loss and promoting hair growth, comprising the following steps:

[0012] (1) Weigh cicada slough according to the above parts by weight, dry it by baking after removing the feet and wings, grind it into fine powder, and set aside;

[0013] (2) Weigh the remaining raw materials according to the above parts by weight, wash and cut them into pieces, add water and decoct them with cicada slough over a slow fire, filter, repeat 2 times, combine the decoction liquid, let it stand until it becomes clear, and filter;

[0014] (3) When the decoction liquid is concentrated by slow fire to a viscous state, add an equal amount of honey and continue to boil until it boils to obtain the product.

[0015] The present invention provides the application of the traditional Chinese medicine composition in the preparation of products for preventing and / or improving and / or treating hair loss.

[0016] Further, the products include but are not limited to medicines, health products, substitute tea, etc.

[0017] The pharmacological effects of each traditional Chinese medicine component in the traditional Chinese medicine composition of the present invention are as follows:

[0018] Sesame flower: sweet and pungent in taste, neutral in nature; having the effects of promoting blood circulation to regulate menstruation, cooling blood and clearing heat; used for irregular menstruation, dysmenorrhea, leukorrhea with red and white discharge, hemoptysis due to lung heat, and painful urination.

[0019] Cockscomb Flower: Sweet, astringent, cool in nature, attributing to the liver and large intestine meridians; having the effects of arresting bleeding, reducing leukorrhea and relieving dysentery; used for hematemesis, metrorrhagia, hematochezia, hemorrhoids bleeding, leukorrhea with red or white discharge, and chronic dysentery. The main active ingredients in cockscomb flower include flavonoids, triterpenoids, organic acids, terpenoids, etc., having pharmacological effects such as hemostasis, anti-aging, enhancing immunity, and protecting the liver.

[0020] Magnolia Flower: Pungent in taste, warm in nature, attributing to the lung and stomach meridians; having the effects of dispersing wind-cold and unblocking nasal orifices; used for headache due to wind-cold, nasal congestion and rhinorrhea, allergic rhinitis, and nasal sinusitis. The main active ingredients in magnolia flower include volatile oils, lignans, polysaccharides, alkaloids, etc., having pharmacological effects such as anti-inflammatory, anti-allergic, antioxidant, and antibacterial.

[0021] Gromwell Root: Sweet and salty in taste, cold in nature, attributing to the heart and liver meridians; having the effects of clearing heat and cooling blood, activating blood circulation to resolve toxins, and promoting eruption and removing macules; used for excessive heat and toxicity, purple and black macules, unsmooth measles, sores and ulcers, eczema, and scalds by fire or water. The main active ingredients in gromwell root include quinones, flavonoids, phenolic acids, etc., having pharmacological effects such as anti-inflammatory, antioxidant, enhancing immunity, promoting blood circulation, and protecting the central nervous system.

[0022] Fleeceflower Root: Bitter, sweet, and astringent in taste, slightly warm in nature, attributing to the liver, heart, and kidney meridians; having the effects of detoxifying, dissipating carbuncles, arresting malaria, and loosening the bowels; used for sores and carbuncles, scrofula, itching due to rubella, chronic malaria with general weakness, and constipation due to intestinal dryness. The main active ingredients in fleeceflower root include stilbene glycosides, anthraquinones, flavonoids, phospholipids, etc., having pharmacological effects such as anti-aging, anti-tumor, reducing blood lipid, anti-inflammatory, blackening hair and preventing hair loss, and enhancing immunity.

[0023] Prepared Rehmannia Root: Sweet in taste, slightly warm in nature, attributing to the liver and kidney meridians; having the effects of enriching blood and nourishing yin, and replenishing essence and marrow; used for sallow complexion due to blood deficiency, palpitation, irregular menstruation, metrorrhagia and menorrhagia, yin deficiency of the liver and kidney, soreness and weakness of the waist and knees, hectic fever, night sweats and spermatorrhea, internal heat and polydipsia, dizziness, tinnitus, and premature whitening of hair. The main active ingredients in prepared rehmannia root include iridoid glycosides, phenyl ethanol glycosides, saccharides, amino acids, etc., having pharmacological effects such as improving the hematopoietic function of the body, anti-aging, anti-tumor, enhancing immunity, and preventing osteoporosis.

[0024] Notopterygium Root: Pungent and bitter in taste, warm in nature, attributing to the bladder and kidney meridians; having the effects of inducing sweating to dispel cold, expelling wind and dampness, and relieving pain; used for common cold due to wind-cold, headache and stiffness of the neck, arthralgia due to wind-dampness, and soreness and pain of the shoulders and back. The main active ingredients in notopterygium root include coumarins, volatile oils, amino acids, saccharides, etc., having pharmacological activities such as anti-inflammatory, antibacterial, promoting blood circulation in the brain, and anti-myocardial ischemia.

[0025] Duhuo: Spicy and bitter in taste, slightly warm in nature, enters the kidney and bladder meridians; has the effects of dispelling wind and dampness, relieving numbness and relieving pain; used for wind-cold-dampness arthralgia, waist and knee pain, Shaoyin hidden wind headache, wind-cold and dampness headache. Duhuo mainly contains active ingredients such as coumarins, volatile oils, sugars, organic acids, etc., and has pharmacological effects such as anti-inflammatory, antioxidant, anti-tumor, protection of the cardiovascular system, and regulation of the central nervous system.

[0026] Daizheshi: bitter and sweet in taste, neutral in nature, enters the liver, stomach and heart meridians; has the effects of calming the liver and suppressing yang, calming the adverse qi, cooling blood and stopping bleeding; used for belching, vomiting, choking and regurgitation, asthma, epilepsy, hematemesis, epistaxis, intestinal wind, hemorrhoids, fistula, metrorrhagia and leucorrhea.

[0027] Cicada shell: sweet and salty, cool in nature, enters the lung and liver meridians; has the effects of dispersing wind-heat, promoting lung function, and calming spasms; used for exogenous wind-heat, hoarseness in cough, poor measles outbreak, urticaria itching, infantile epilepsy, red eyes, cataract, furuncle swelling, tetanus. Cicada shell mainly contains active ingredients such as N-acetyl dopamine derivatives, polysaccharides, amino acids, etc., which have pharmacological effects such as anti-inflammatory, antioxidant, and cardiovascular protection.

[0028] (III) Beneficial effects

[0029] The invention provides a traditional Chinese medicine composition for preventing hair loss and promoting hair growth and its application. The traditional Chinese medicine composition is composed of ten traditional Chinese medicines including sesame flower, cockscomb, magnolia flower, lithospermum officinale, polygonum multiflorum, rehmannia root, notopterygium wilfordii, angelica pubescens, magnetite and cicada shell. The prescription uses sesame flower and cockscomb as main medicines. Sesame flower nourishes liver and kidney, nourishes blood and promotes hair growth. Cockscomb cools blood and stops bleeding, dispels wind and relieves itching. The two complement each other, can enhance liver and kidney function, promote blood circulation, effectively promote hair growth, and relieve symptoms such as scalp itching. Polygonum multiflorum, rehmannia root and lithospermum officinale are used as assistant medicines. Polygonum multiflorum nourishes liver and kidney, improves essence and blood, and blackens hair. Rehmannia root nourishes blood and nourishes yin. It replenishes essence and fills marrow, while Lithospermum officinale cools blood, promotes blood circulation, detoxifies and clears rashes. The combination of the three can assist the main medicine to further enhance the effects of nourishing the liver and kidney, nourishing blood and promoting hair growth, while improving the scalp environment and nutrient supply; Notopterygium wilfordii, Angelica dahurica and Magnolia flower are used as adjuvants. Notopterygium wilfordii relieves exterior symptoms and dispels cold, dispels wind and dampness, while Angelica dahurica dispels wind and dampness, relieves numbness and relieves pain, while Magnolia flower dispels cold and opens the orifices, which can assist the main and ministerial medicines in strengthening the body and eliminating evil, dispelling wind and dampness, and improving the scalp environment; Daizheshi and cicada shell are used as guiding medicines. Daizheshi calms the liver and suppresses yang, cools blood and stops bleeding, while cicada shell dispels wind-heat, improves eyesight and removes cataracts. The two coordinate the effects of the drugs, balance the rise and fall, and harmonize the Qi, so that the whole prescription is nourishing without stagnation, and clears without causing cold.

[0030] The traditional Chinese medicine composition of the present invention can promote the proliferation of human dermal papilla cells (HDPCs), reduce the degree of damage to HDPCs, induce hair follicle cycle transformation, thereby achieving the effect of promoting hair growth; it can significantly increase the number of hair follicles, the thickness of the skin and dermal fat in mice, reduce the levels of serum IL-2, TNF-α, and TGF-β1 in mice, and reduce the levels of testosterone, dihydrotestosterone, and estradiol in the skin tissues of mice, thereby inhibiting hair follicle fibrosis, accelerating the entry of hair follicles into the growth phase and prolonging the growth phase, improving the phenomenon of hair loss, and promoting hair growth. Detailed implementation manners

[0031] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are some, rather than all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without making creative efforts belong to the scope of protection of the present invention.

[0032] Example 1

[0033] A traditional Chinese medicine composition for preventing hair loss and promoting hair growth, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 30 parts of sesame flower, 30 parts of cockscomb flower, 30 parts of magnolia flower, 30 parts of lithospermum root, 30 parts of fleece-flower root, 15 parts of prepared rehmannia root, 10 parts of notopterygium root, 10 parts of pubescent angelica root, 30 parts of hematite, and 10 parts of cicada slough.

[0034] Example 2

[0035] The difference between this example and Example 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 34 parts of sesame flower, 33 parts of cockscomb flower, 38 parts of magnolia flower, 38 parts of lithospermum root, 32 parts of fleece-flower root, 18 parts of prepared rehmannia root, 16 parts of notopterygium root, 16 parts of pubescent angelica root, 33 parts of hematite, and 18 parts of cicada slough.

[0036] Example 3

[0037] The difference between this example and Example 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 41 parts of sesame flower, 40 parts of cockscomb flower, 43 parts of magnolia flower, 43 parts of lithospermum root, 38 parts of fleece-flower root, 23 parts of prepared rehmannia root, 20 parts of notopterygium root, 20 parts of pubescent angelica root, 42 parts of hematite, and 24 parts of cicada slough.

[0038] Example 4

[0039] The difference between this example and Example 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 22 parts of sesame flower, 25 parts of cockscomb flower, 20 parts of magnolia flower, 20 parts of lithospermum root, 25 parts of fleece-flower root, 12 parts of prepared rehmannia root, 10 parts of notopterygium root, 10 parts of pubescent angelica root, 20 parts of hematite, and 10 parts of cicada slough.

[0040] Example 5

[0041] The difference between this example and Example 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 20 parts of sesame flower, 23 parts of cockscomb flower, 18 parts of magnolia flower, 18 parts of lithospermum root, 23 parts of fleece-flower root, 10 parts of prepared rehmannia root, 8 parts of notopterygium root, 8 parts of pubescent angelica root, 18 parts of hematite, and 8 parts of cicada slough.

[0042] Example 6

[0043] The difference between this example and Example 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 18 parts of sesame flower, 20 parts of cockscomb flower, 15 parts of magnolia flower, 15 parts of lithospermum root, 20 parts of fleece-flower root, 8 parts of prepared rehmannia root, 5 parts of notopterygium root, 5 parts of pubescent angelica root, 15 parts of hematite, and 5 parts of cicada slough.

[0044] Example 7

[0045] The difference between this example and Example 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 36 parts of sesame flower, 38 parts of cockscomb flower, 40 parts of magnolia flower, 40 parts of lithospermum root, 35 parts of fleece-flower root, 20 parts of prepared rehmannia root, 17 parts of notopterygium root, 18 parts of pubescent angelica root, 36 parts of hematite, and 20 parts of cicada slough.

[0046] Example 8

[0047] The difference between this example and Example 1 is that the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 25 parts of sesame flower, 28 parts of cockscomb flower, 23 parts of magnolia flower, 23 parts of lithospermum root, 28 parts of fleece-flower root, 15 parts of prepared rehmannia root, 12 parts of notopterygium root, 13 parts of pubescent angelica root, 22 parts of hematite, and 11 parts of cicada slough.

[0048] Test Example 1

[0049] 1 Materials and Methods

[0050] 1.1 Experimental Drugs

[0051] Test Group 1: 30 parts of sesame flower, 30 parts of cockscomb flower, 30 parts of magnolia flower, 30 parts of lithospermum root, 30 parts of fleece-flower root, 15 parts of prepared rehmannia root, 10 parts of notopterygium root, 10 parts of pubescent angelica root, 30 parts of hematite, and 10 parts of cicada slough.

[0052] Test Group 2: 30 parts of magnolia flower, 30 parts of lithospermum root, 30 parts of fleece-flower root, 15 parts of prepared rehmannia root, 10 parts of notopterygium root, 10 parts of pubescent angelica root, 30 parts of hematite, and 10 parts of cicada slough.

[0053] Test Group 3: 30 parts of sesame flower, 30 parts of cockscomb flower, 30 parts of fleece-flower root, 15 parts of prepared rehmannia root, 10 parts of notopterygium root, 10 parts of pubescent angelica root, 30 parts of hematite, and 10 parts of cicada slough.

[0054] Test group 4: 30 parts of sesame flower, 30 parts of cockscomb flower, 30 parts of magnolia flower, 30 parts of lithospermum root, 10 parts of angelica pubescens, 30 parts of hematite, 10 parts of cicada slough.

[0055] Test group 5: 30 parts of sesame flower, 30 parts of cockscomb flower, 30 parts of magnolia flower, 30 parts of lithospermum root, 30 parts of fleeceflower root, 15 parts of prepared rehmannia root, 10 parts of incised notopterygium root.

[0056] Weigh each raw material according to the above weight parts respectively. Remove the feet and wings of cicada slough, then dry and grind it into fine powder. Wash and cut the remaining raw materials, extract them with water by ultrasonic for 1.5 h, filter, repeat 2 times, combine the filtrates, and concentrate to a crude drug content of 1 g / mL to obtain each traditional Chinese medicine stock solution.

[0057] 1.2 Cell culture

[0058] Resuscitate human dermal papilla cells (HDPC) in mesenchymal stem cell medium containing 10% fetal bovine serum, 1% penicillin-streptomycin, and stem cell growth factor, and culture them in a cell incubator at 37°C and 5% CO 2 , and perform routine passage and medium replacement.

[0059] 1.3 Detection indexes

[0060] 1.3.1 Cell proliferation activity

[0061] Take HDPC in the logarithmic growth phase, inoculate them in a 96-well plate at a density of 1×10 4 cells / well, set up a blank control group and test groups 1-5, with 3 replicates in each group. Culture them in a cell incubator at 37°C and 5% CO 2 for 24 h. After the cells adhere, the blank control group is given 200 μL of complete medium, and test groups 1-5 are given 200 μL of medium containing 200 μg / mL of each drug. After continuing to culture for 24 h, add 10 μL of CCK-8 to each well, incubate for 1-4 h, and then measure the absorbance at 450 nm with an enzyme-linked immunosorbent assay (ELISA) reader to calculate the cell viability. Cell proliferation rate = OD 药物组 / OD 空白组 ×100%.

[0062] 1.3.2 Detection of VEGF and HDF levels

[0063] Take HDPC in the logarithmic growth phase, inoculate them in a 24-well plate at a density of 2×10 5 cells / well, set up a blank control group and test groups 1-5, and culture them at 37°C and 5% CO 2Cultured in a cell incubator for 24 h. After the cells adhered to the wall, the blank control group was given 1 mL of complete medium, and the experimental groups 1-5 were given 1 mL of medium containing 200 μg / mL of each drug. After continuous culture for 24 h, the supernatant was collected, and the contents of VEGF and HGF were measured according to the instructions of the ELISA kit.

[0064] 1.4 Statistical methods

[0065] Data analysis was performed using Graphpad Prism 8 statistical software, and the mean ± standard deviation (s) was used to represent the data. One-way ANOVA was used for statistical analysis, and a difference was considered statistically significant when P < 0.05.

[0066] 2 Results

[0067] 2.1 Effects of each drug on the proliferation of HDPC

[0068] As shown in Table 1, compared with the blank control group, the experimental groups 1-5 all had varying degrees of promoting effects on the proliferation ability of human dermal papilla cells (HDPC). Among them, the promoting effect of the experimental group 1 was the strongest (P < 0.01). Although the proliferation ability of HDPC in the experimental groups 2-3 showed an upward trend, the difference was not statistically significant (P > 0.05).

[0069] Table 1 Comparison of HDPC proliferation in each group

[0070] Grouping Proliferation ability Blank control group 100.75±1.41 Test group 1 <![CDATA[154.42±10.15 ** > Test group 2 103.58±2.92 Test group 3 113.47±2.80 Test group 4 <![CDATA[120.63±5.57 ** > Test group 5 <![CDATA[130.84±4.54 ** >

[0071] Note: Compared with the blank control group, * P < 0.05, ** P < 0.01.

[0072] 2.2 Effects of each drug on the secretion of VEGF and HGF by HDPC

[0073] Table 2 shows the effects of each drug group on the secretion of VEGF and HGF by human dermal papilla cells (HDPC). Compared with the blank control group, the experimental groups 1-5 could all up-regulate the expression levels of VEGF and HGF to varying degrees (P < 0.05, P < 0.01). Among them, the up-regulation effect of the experimental group 1 was the most significant.

[0074] Table 2 Comparison of the secretion of VEGF and HGF by cells in each group

[0075]

[0076]

[0077] Note: Compared with the blank control group, * P < 0.05, **P < 0.01.

[0078] 3 Conclusions

[0079] The above experimental data show that the traditional Chinese medicine composition of the present invention can effectively promote the proliferation of human dermal papilla cells (HDPCs), up-regulate the expression levels of VEGF and HGF, thereby reducing the degree of damage to human dermal papilla cells, inducing hair follicle cycle transformation, and promoting hair growth. Among them, the experimental group 1 showed the most significant promoting effect. In experimental groups 2-5, due to the lack of some traditional Chinese medicine components, their promoting effects were limited to varying degrees, which further proved that the efficacy of the traditional Chinese medicine composition of the present invention is based on the reasonable compatibility principle of traditional Chinese medicine theory, and none of the traditional Chinese medicine components can be missing.

[0080] Experimental Example 2

[0081] 1 Materials and Methods

[0082] 1.1 Experimental Animals

[0083] Thirty-six SPF-grade C57BL / 6N mice, male, 6-7 weeks old, weighing 20 ± 2 g, were provided by Beijing Vital River Laboratory Animal Technology Co., Ltd.

[0084] 1.2 Experimental Drugs

[0085] 30 parts of sesame flower, 30 parts of cockscomb flower, 30 parts of magnolia flower, 30 parts of lithospermum root, 30 parts of fleece-flower root, 15 parts of prepared rehmannia root, 10 parts of notopterygium root, 10 parts of pubescent angelica root, 30 parts of hematite, 10 parts of cicada slough.

[0086] Weigh each raw material according to the above weight parts. After removing the feet and wings of the cicada slough, it was dried and ground into fine powder. The remaining raw materials were washed and chopped, soaked in water for 20-30 min, then transferred to a casserole and decocted for 20-30 min. Filtered while it was hot, repeated twice, and the two filtrates were combined and concentrated to a crude drug content of 1 g / mL to obtain the traditional Chinese medicine stock solution.

[0087] Minoxidil tincture, purchased from Zhejiang Wansheng Pharmaceutical Co., Ltd.

[0088] 1.3 Establishment, Grouping and Administration of Experimental Animal Models

[0089] After anesthetizing C57BL / 6N mice, remove the hair from the areas on both sides of the dorsal midline that are slightly larger than 1×2 cm. Use depilatory cream to depilate the depilated areas and then put the mice back into the cage for breeding. Observe the skin condition of the depilated areas on the backs of the mice 1 day after depilation. Exclude the mice with large patches of melanin or skin damage on the skin that seriously affect the subsequent evaluation of drug efficacy. Randomly divide the remaining mice into 6 groups, namely the blank control group, the model control group, the minoxidil group, the high-dose traditional Chinese medicine composition group, the medium-dose traditional Chinese medicine composition group, and the low-dose traditional Chinese medicine composition group, with 6 mice in each group. Except for the blank group, apply 0.1 mL / cm of testosterone solution with a mass concentration of 1 mg / mL to the depilated areas on the backs of the mice in the other groups 2 , and apply an equal volume of 75% ethanol solution to the blank control group. Administer the drug 2 hours after modeling every day. Apply 0.1 mL / cm of 5% minoxidil tincture to the depilated areas on the backs of the mice in the minoxidil group 2 . Administer 200 mg / kg of the traditional Chinese medicine composition of the present invention by gavage to the high-dose traditional Chinese medicine composition group, administer 100 mg / kg of the traditional Chinese medicine composition of the present invention by gavage to the medium-dose traditional Chinese medicine composition group, administer 50 mg / kg of the traditional Chinese medicine composition of the present invention by gavage to the low-dose traditional Chinese medicine composition group, and administer an equal volume of normal saline by gavage to the blank control group and the model control group. Do this once a day for 28 consecutive days.

[0090] 1.4 Observation indicators

[0091] 1.4.1 Hair growth status

[0092] Observe the hair growth status on the backs of the mice every week. After the last administration, randomly pluck 10 hairs from the depilated areas of the mice to measure the length.

[0093] 1.4.2 Observe the changes in the skin and hair follicles by pathological section

[0094] Anesthetize and sacrifice the mice 1 hour after the last administration. Take the back skin tissue, fix it in 4% paraformaldehyde for 24 hours, dehydrate it, then perform paraffin embedding, sectioning, dehydration, HE staining, and mounting. Observe and record the skin thickness, dermal fat thickness, and hair follicle number under an optical microscope.

[0095] 1.4.3 Expression levels of serum IL-2, TNF-α, and TGF-β1

[0096] One hour after the last administration, collect blood from the orbital cavities of the mice, 4 mL per mouse. Let it stand for 30 minutes, then centrifuge at 4°C and 3000 rpm for 30 minutes. Take the supernatant and detect the contents of IL-2, TNF-α, and TGF-β1 in the serum according to the instructions of the ELISA kit.

[0097] 1.4.4 Determination of the contents of testosterone, dihydrotestosterone, and estradiol in the skin of mice

[0098] One hour after the last administration, the mice were anesthetized, and the back skin tissues were taken and weighed. PBS solution was added at a mass-to-volume ratio of 1:9, and the skin tissues were ground thoroughly using a cryogenic grinder (4 °C, 90 s, 65 Hz) to prepare a homogenate. The homogenate was centrifuged at 4 °C and 12,000 rpm for 30 min, and the supernatant was collected. The contents of testosterone, dihydrotestosterone, and estradiol were measured according to the instructions of the ELISA kit.

[0099] 1.4.5 Statistical methods

[0100] Data analysis was performed using Graphpad Prism 8 statistical software, and the results were expressed as mean ± standard deviation (s). One-way ANOVA was used for statistical analysis, and a difference was considered statistically significant when P < 0.05.

[0101] 2 Results

[0102] 2.1 Effects of each drug on the hair growth status of mice

[0103] As shown in Table 1, compared with the blank control group, the length of the newly grown hair of the mice in the model control group was significantly reduced (P < 0.01); compared with the model control group, the length of the newly grown hair of the mice in each drug administration group was significantly increased (P < 0.05, P < 0.01), and there was a certain dose-dependence, indicating that the traditional Chinese medicine composition of the present invention can significantly promote hair growth in mice with androgenetic alopecia.

[0104] Table 1 Comparison of the length of newly grown hair of mice in each group

[0105] Grouping Hair length Blank control group 7.36±0.29 Model control group <![CDATA[5.68±0.27 ## > Minoxidil group <![CDATA[7.24±0.21 ** > High-dose group of traditional Chinese medicine composition <![CDATA[7.15±0.10 ** > Medium-dose group of traditional Chinese medicine composition <![CDATA[6.65±0.11 ** > Low-dose group of traditional Chinese medicine composition <![CDATA[6.27±0.10 * >

[0106] Note: Compared with the blank control group, # P < 0.05, ## P < 0.01; compared with the model control group, * P < 0.05, ** P < 0.01.

[0107] 2.2 Effects of each drug on the skin and hair follicle numbers of mice

[0108] As shown in Table 2, compared with the blank control group, the skin thickness and dermal thickness of the mice in the model control group were significantly decreased (P < 0.01), and the number of hair follicles was significantly reduced (P < 0.01); compared with the model control group, the skin thickness, dermal thickness, and number of hair follicles of the mice in each drug administration group were significantly increased (P < 0.05, P < 0.01), and there was a certain dose-dependence, indicating that the traditional Chinese medicine composition of the present invention can increase the number of hair follicles in mice with androgenetic alopecia, extend the hair growth period, and thus promote hair growth.

[0109] Table 2 Comparison of the skin and hair follicle numbers of mice in each group

[0110]

[0111]

[0112] Note: Compared with the blank control group, # P < 0.05, ## P < 0.01; compared with the model control group, * P < 0.05, ** P < 0.01.

[0113] 2.3 Effects of each drug on the levels of IL-2, TNF-α, and TGF-β1 in mouse serum

[0114] As shown in Table 3, compared with the blank control group, the levels of IL-2, TNF-α, and TGF-β1 in the serum of mice in the model control group were significantly increased (P < 0.01); compared with the model control group, the levels of IL-2, TNF-α, and TGF-β1 in the serum of mice in each drug administration group decreased to varying degrees, among which the high-dose group had the most significant effect (P < 0.01); indicating that the traditional Chinese medicine composition of the present invention can inhibit follicular fibrosis in androgenetic alopecia mice, accelerate the hair follicles to enter the growth phase, and promote hair growth.

[0115] Table 3 Comparison of serum factors in each group of mice

[0116] Grouping IL-2 (pg / mL) TNF-α (pg / mL) TGF-β1 (pg / mL) Blank control group 89.41±3.79 54.28±5.03 626.85±10.98 Model control group <![CDATA[167.74±8.47 ## > <![CDATA[92.83±3.57 ## > <![CDATA[816.20±9.29 ## > Minoxidil group <![CDATA[112.42±7.07 ** > <![CDATA[65.28±3.58 ** > <![CDATA[692.73±8.53 ** > High-dose group of traditional Chinese medicine composition <![CDATA[124.13±11.09 ** > <![CDATA[71.22±2.68 ** > <![CDATA[715.96±8.71 ** > Medium-dose group of traditional Chinese medicine composition <![CDATA[134.56±7.81 ** > <![CDATA[77.19±2.33 ** > <![CDATA[743.26±11.06 ** > Low-dose group of traditional Chinese medicine composition 152.74±6.35 <![CDATA[82.77±1.74 * > <![CDATA[776.08±9.07 ** >

[0117] Note: Compared with the blank control group, # P < 0.05, ## P < 0.01; compared with the model control group, * P < 0.05, ** P < 0.01.

[0118] 2.4 Effects of each drug on the hormone levels in mice

[0119] As shown in Table 4, compared with the blank control group, the levels of testosterone, dihydrotestosterone, and estradiol in the skin tissue of mice in the model control group were significantly increased (P < 0.01); compared with the model control group, the levels of testosterone, dihydrotestosterone, and estradiol in the skin tissue of mice in each drug administration group decreased to varying degrees, among which the high-dose group had the most significant effect (P < 0.01); indicating that the traditional Chinese medicine composition of the present invention can improve the local follicular hormone receptor levels in androgenetic alopecia mice and improve phenomena such as hair loss.

[0120] Table 4 Comparison of hormone levels in each group of mice

[0121]

[0122]

[0123] Note: Compared with the blank control group, # P < 0.05, ## P < 0.01; compared with the model control group, * P < 0.05, ** P < 0.01.

[0124] 3 Conclusions

[0125] The above test results show that the traditional Chinese medicine composition of the present invention has a good effect on preventing hair loss and promoting hair growth, can promote hair regeneration in androgenetic alopecia mice, significantly increase the number of hair follicles, the thickness of the skin and dermal fat in mice, prolong the hair growth phase, and promote hair growth; significantly reduce the levels of serum IL-2, TNF-α, and TGF-β1 in mice, inhibit hair follicle fibrosis, accelerate the entry of hair follicles into the growth phase, and promote hair growth; reduce the levels of testosterone, dihydrotestosterone, and estradiol in the skin tissue of mice, and improve phenomena such as hair loss.

[0126] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicine composition for preventing hair loss and promoting hair growth, characterized in that: The invention is composed of the following raw materials in parts by weight: 18-43 parts of sesame flower, 20-40 parts of cockscomb flower, 15-45 parts of magnolia flower, 15-45 parts of lithospermum officinale, 20-40 parts of polygonum multiflorum, 8-23 parts of rehmannia root, 5-20 parts of notopterygium root, 5-20 parts of angelica dahurica, 15-45 parts of magnetite and 5-25 parts of cicada shell.

2. A Chinese medicine composition for preventing hair loss and promoting hair growth according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 20-40 parts of sesame flower, 22-35 parts of cockscomb flower, 20-40 parts of magnolia flower, 20-40 parts of lithospermum officinale, 22-35 parts of polygonum multiflorum, 10-18 parts of rehmannia root, 8-16 parts of notopterygium root, 8-16 parts of angelica root, 20-40 parts of magnetite and 8-16 parts of cicada shell.

3. A Chinese medicine composition for preventing hair loss and promoting hair growth according to claim 1, characterized in that: The invention is composed of the following raw materials in parts by weight: 30 parts of sesame flower, 30 parts of cockscomb flower, 30 parts of magnolia flower, 30 parts of lithospermum officinale, 30 parts of polygonum multiflorum, 15 parts of rehmannia root, 10 parts of notopterygium root, 10 parts of angelica root, 30 parts of magnetite and 10 parts of cicada shell.

4. The use of a Chinese medicine composition for preventing hair loss and promoting hair growth as claimed in any one of claims 1 to 3, characterized in that: The traditional Chinese medicine composition is used for preparing a product for preventing and / or improving and / or treating hair loss.

5. The anti-hair loss and hair growth product according to claim 4, characterized in that: The products include but are not limited to medicines, health products, tea substitutes, etc.

Images