Traditional Chinese medicine composition for treating hair loss and screening method, preparation method and application thereof

Abstract

The present invention provides a Chinese medicine composition for treating alopecia and a screening method, a preparation method and an application thereof, and belongs to the technical field of Chinese medicine. The present invention utilizes a network pharmacology method to screen and obtain a Chinese medicine composition (Dodder seed, Polygonatum sibiricum, Chuanxiong, Carthamus tinctorius, Ginseng, Licorice, Polygonum multiflorum) for treating alopecia that can completely cover 288 alopecia-related targets. The Chinese medicine composition for treating alopecia of the present invention uses Polygonum multiflorum as the monarch drug, Dodder seed and Polygonatum sibiricum as the ministerial drug, Ginseng, Carthamus tinctorius, Chuanxiong as the adjuvant drug, Licorice as the messenger drug, the medicine is simple and powerful, and the whole party plays the effect of tonifying the liver and kidney, invigorating qi and activating blood circulation, without obvious incompatibility taboos, for preventing and treating alopecia, promoting hair regeneration, and is particularly suitable for alopecia syndromes with liver and kidney deficiency and insufficient essence and blood in TCM differentiation, and the patient has a significant effect after using it for 7-8 weeks, and the cure rate can reach 63.0%, the effective rate can reach 95.1%, and there is no rebound.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating hair loss, a screening method, a preparation method and an application thereof. Background Art

[0002] Hair loss is a common skin disease, which is closely related to genetics, aging, immunity, hormones, infection, mental and psychological factors. Traditional Chinese medicine has a long history of preventing and treating hair loss and is of great significance in traditional medicine. Traditional Chinese medicine for preventing and treating hair loss is mainly in the category of tonifying deficiency, clearing away heat and promoting blood circulation and removing blood stasis. In addition to the pharmacological activity of hair growth and development, this type of traditional Chinese medicine also has the characteristics of regulating abnormal hair follicle growth through multiple pathways, multiple targets and multiple channels.

[0003] The journal article ("Discussion on the Treatment of Seborrheic Alopecia with Traditional Chinese Medicine Platycladus orientalis Leaves", Li Guihua et al., "Exploration of Rational Drug Use in China", Issue 5, 2023) discusses the active ingredients, treatment mechanisms, clinical compatibility, clinical efficacy and treatment advantages of Platycladus orientalis leaves in the treatment of seborrheic alopecia. Modern pharmacological studies have shown that the active ingredients of the main extracts of Platycladus orientalis leaves, such as volatile oils, flavonoids and tannins, can increase the nutrition of hair follicles, promote blood circulation, accelerate the nutrient absorption of related cells, and effectively inhibit bacteria, thereby promoting hair growth and improving the symptoms of hair loss. Clinical trial studies have shown that prescriptions and medicines containing Platycladus orientalis leaves have significant clinical efficacy, few adverse reactions, and are easily accepted by most patients. However, this paper did not focus on the targets of the traditional Chinese medicine Platycladus orientalis leaves and their compound medicines.

[0004] The journal article ("The Application of Traditional Chinese Medicine Prescriptions in the Treatment of Seborrheic Alopecia", Li Rong et al., "Guangming Chinese Medicine" Issue 12, 2022) believes that the formation of seborrheic alopecia is due to dysfunction of the liver, spleen, and kidney. Deficiency of both the liver and kidney and insufficient essence and blood cause the hair to lose nourishment, and damp heat from the spleen and stomach rises to the hair roots, causing hair to fall out. The syndrome differentiation and classification of seborrheic alopecia are relatively complex, and there is a possibility of mutual transformation, so the combined use of traditional Chinese medicine prescriptions can improve the treatment effect. Traditional Chinese medicine pays attention to the overall concept and syndrome differentiation and treatment, so there is a viewpoint of different treatments for the same disease and the same treatment for different diseases. In the prescriptions used, the essence is grasped and added or subtracted according to the syndrome. In addition, modern pharmacological studies have confirmed that many traditional Chinese medicines have the effect of directly or indirectly inhibiting the production of androgens, which also proves the reliability of traditional Chinese medicine prescriptions in the treatment of seborrheic alopecia. However, the paper did not specifically study the mechanism or target of traditional Chinese medicine prescriptions in the treatment of hair loss.

[0005] Hair loss is a complex disease involving multiple factors, multiple targets and multiple mechanisms. Although there are many traditional Chinese medicines and active ingredients that can promote hair follicle growth, the number of hair loss-related disease targets that can be acted on by using a certain traditional Chinese medicine or active ingredient alone only accounts for a small part of the number of hair loss-related targets. At present, the scope of action of many mainstream hair growth traditional Chinese medicines has not yet covered most of the hair loss-related targets, which is the main reason why hair loss is difficult to cure. On the other hand, it also suggests that in order to improve the efficacy of traditional Chinese medicine in preventing and treating hair loss, we should not rely solely on traditional Chinese medicine monomers or single traditional Chinese medicines to achieve the treatment goal, but should take into account the characteristics of each traditional Chinese medicine or traditional Chinese medicine monomer, and make formulas according to scientific proportions.

[0006] We previously searched for about 14,171 targets related to hair loss with the help of disease databases such as Gene Cards. We further collected 20 traditional Chinese medicines reported in the literature and confirmed to have the effect of promoting hair follicle growth by in vivo or in vitro experiments, including Angelica dahurica, Nepeta tenuifolia, Platycladus orientalis, Angelica sinensis, Carthamus tinctorius, Ligustrum lucidum, Polygonatum sibiricum, Ginger, Ligustrum lucidum, Licorice, Astragalus, Ginseng, Coriander, Lygodium japonicus, Cuscuta australis, Rehmannia glutinosa, Rehmannia glutinosa, Polygonum multiflorum, Sophora flavescens, and Codonopsis pilosula, and used the Chinese medicine system pharmacology database and analysis platform (https: / /

[0007] / / tcmsp-e.com / index.php) and HIT 2.0 Chinese herbal medicine component target analysis platform (http: / / hit2.badd-cao.net / ) analyzed and screened the active ingredients and targets of each of the above Chinese medicines, and found that most hair-growth Chinese medicines contained a high degree of duplication of active ingredients and targets. After removing duplicate targets, the 20 hair-growth Chinese medicines investigated can cover 288 hair loss-related targets, suggesting that blindly superimposing Chinese medicines may only increase the content of a specific active ingredient, and may not necessarily expand the target range covered by hair-growth Chinese medicines and improve the efficacy. In addition, the course of hair loss treatment is long (2-12 months). If the selected Chinese medicine compound for hair loss has a large formula and complex active ingredients, it will not only increase the economic burden on patients; but also the complex formula composition is easy to interact with other drugs during long-term medication, increasing the incidence of adverse reactions.

[0008] Based on this, the present invention further optimizes and simplifies using network pharmacology methods, and re-screens and combines a Chinese medicine combination (Dodder, Polygonatum, Chuanxiong, Carthami, Ginseng, Licorice, Polygonum multiflorum) that can completely cover the above 288 hair loss-related targets. The hair-growth Chinese medicine combination has been proven to be safe and effective after clinical use. It can treat mild to moderate hair loss and relieve hair loss after 1 week, and relieve symptoms of itchy and oily scalp. Most patients have significant efficacy after 7-8 weeks of use, and there is no rebound. Summary of the invention

[0009] The present invention aims at the problems existing in the prior art and provides a Chinese medicine composition for treating hair loss and a screening method, a preparation method and an application thereof. The present invention uses a network pharmacology method to screen and obtain a Chinese medicine composition for treating hair loss (cuscuta, polygonatum, chuanxiong, safflower, ginseng, liquorice, and polygonum multiflorum) that can completely cover 288 hair loss-related targets. The Chinese medicine composition for treating hair loss of the present invention uses polygonum multiflorum as the main drug, cuscuta and polygonatum as the ministerial drugs, ginseng, safflower, and chuanxiong as the adjuvant drugs, and liquorice as the guiding drug. The medicine is simple and powerful, and the whole prescription has the effect of nourishing the liver and kidney, invigorating qi and activating blood circulation, has no obvious incompatibility taboos, is used to prevent and treat hair loss, and promotes hair regeneration, and is particularly suitable for hair loss syndromes with liver and kidney deficiency and insufficient essence and blood in TCM diagnosis. The Chinese medicine composition for treating hair loss has been proven to be safe and effective after clinical use. It can reduce hair loss and relieve symptoms of itchy and oily scalp in one week for mild to moderate hair loss. The therapeutic effect is significant after 7-8 weeks of use, with a cure rate of 63.0%, an effective rate of 95.1%, and no rebound.

[0010] To achieve the above object, in a first aspect, the present invention provides a method for screening a Chinese medicine composition for treating hair loss, comprising the following steps:

[0011] The screening method comprises the following steps:

[0012] 1) Collecting literature on traditional Chinese medicine for hair loss through database, and collecting 20 traditional Chinese medicines reported in literature and confirmed by in vivo or in vitro experiments to have the effect of promoting hair follicle growth, including angelica dahurica, schizonepeta tenuifolia, cypress leaf, angelica sinensis, safflower, chuanxiong, polygonatum, ginger, glossy privet fruit, liquorice, astragalus, ginseng, coriander, sea sand, dodder seed, raw rehmannia root, cooked rehmannia root, polygonum multiflorum, sophora flavescens, and codonopsis pilosula;

[0013] 2) Analyze and screen the active ingredients and targets of each of the above-mentioned traditional Chinese medicines with the help of an analysis platform or a research platform, remove duplicate targets, and obtain a traditional Chinese medicine target data set;

[0014] 3) Collecting hair loss related targets through the database to obtain a hair loss target data set;

[0015] 4) Intersecting the TCM target dataset from step 2) with the hair loss target dataset from step 3) to obtain 288 hair loss-related targets covered by the 20 hair-growth TCMs investigated;

[0016] 5) Screening the 20 traditional Chinese medicines, deleting the traditional Chinese medicines containing the same active ingredients or the same targets, retaining the traditional Chinese medicines covering more active ingredients or targets, and screening out the smallest group of traditional Chinese medicine compositions for treating hair loss that completely covers the above 288 hair loss-related targets through continuous comparison and analysis; the traditional Chinese medicine composition for treating hair loss is a combination of Cuscuta australis, Polygonatum sibiricum, Ligusticum chuanxiong, Carthami, Ginseng, Licorice, and Polygonum multiflorum.

[0017] In a preferred embodiment, the database in step 1) is Pubmed, EMBASE, CNKI, CSTJ and Wanfang; the analysis platform or research platform in step 2) is the Traditional Chinese Medicine System Pharmacology Database and Analysis Platform (https: / / www.tcmwell.com / ).

[0018] / / tcmsp-e.com / index.php), HIT 2.0 Chinese herbal medicine ingredient target analysis platform (http: / / hit2.badd-cao.net / ) and TCMIP, a traditional Chinese medicine integrative pharmacology research platform; the databases described in step 3) are TTD, OMIM and GeneCards disease databases.

[0019] The present invention collects traditional Chinese medicines with the efficacy of treating hair loss, and uses network pharmacology analysis to screen out a traditional Chinese medicine composition with multiple targets for treating hair loss. The traditional Chinese medicine composition (cuscuta chinensis, polygonatum sibiricum, ligusticum chuanxiong, safflower, ginseng, liquorice, and polygonum multiflorum) can cover 288 hair loss-related disease targets. Compared with the existing technology, it uses fewer medicinal materials and covers more targets. It also has a concise taste, mild medicinal properties, good taste, definite efficacy during clinical application, no obvious adverse reactions, and high patient acceptance.

[0020] In a second aspect, the present invention provides a Chinese medicine composition for treating hair loss obtained by the above screening method, wherein the Chinese medicine composition is composed of the following components in parts by weight:

[0021] 6-15 parts of Cuscuta seeds, 10-15 parts of Polygonatum sibiricum, 6-10 parts of Ligusticum chuanxiong, 6-10 parts of Carthamus tinctorius, 6-15 parts of Ginseng, 6-10 parts of Liquorice, and 6-15 parts of Polygonum multiflorum.

[0022] The Chinese medicine composition for treating hair loss of the present invention uses Polygonum multiflorum as the main drug. Polygonum multiflorum tastes bitter, sweet and astringent, is warm in nature, and enters the liver and kidney meridians. It has the effects of nourishing the liver and kidney, nourishing blood and dispelling wind. "Polygonum multiflorum record": "strengthen the muscles, benefit the essence, strengthen the qi, keep the face, blacken the hair, and prolong life." "Kaibao revised Materia Medica": "It is used to treat scrofula, eliminate carbuncle, and treat wind sores on the head and face." "Compendium of Materia Medica":

[0023] "This substance is warm in nature and bitter in taste. Bitterness nourishes the kidneys, warmth nourishes the liver, and can restrain essence and qi, so it can nourish the blood and benefit the liver, consolidate essence and benefit the kidneys, strengthen the tendons and bones, and blacken hair. It is a good tonic, neither cold nor dry, and its efficacy is better than that of Rehmannia glutinosa and Asparagus cochinchinensis."

[0024] Cuscuta and Polygonatum are the assistant drugs. Cuscuta is pungent and sweet, neutral in nature, and enters the kidney, liver, and spleen meridians. It has the effects of tonifying the kidney and consolidating essence, nourishing the liver and improving eyesight, and strengthening the spleen and stopping diarrhea; Polygonatum is sweet, neutral in nature, and enters the spleen, lung, and kidney meridians. It has the effects of tonifying qi and nourishing yin, strengthening the spleen, moistening the lungs, and benefiting the kidneys. The combination of the two can enhance the ability of Polygonum multiflorum to nourish the liver and kidneys.

[0025] Ginseng, safflower and Chuanxiong are adjuvants. Ginseng tastes sweet and slightly bitter, is slightly warm in nature, and enters the spleen, lung, heart, and kidney meridians. It has the effects of greatly replenishing vital energy, tonifying the spleen and lungs, promoting body fluid, calming the mind and improving intelligence; safflower tastes pungent and is warm in nature; it enters the heart and liver meridians, and has the effects of promoting blood circulation, dredge menstruation, removing blood stasis and relieving pain; Chuanxiong tastes pungent and is warm in nature; it enters the liver, gallbladder, and pericardium meridians, and has the effects of promoting blood circulation, removing wind and relieving pain. The three are used together to show the effect of replenishing qi and activating blood circulation, making the whole prescription nourishing without stagnation.

[0026] Licorice is a guiding drug. Licorice is sweet, neutral in nature, and enters the heart, lung, spleen, and stomach meridians. It has the effects of replenishing qi and tonifying the middle, moistening the lungs and relieving cough, clearing away heat and detoxifying, relieving pain, and harmonizing the properties of the drugs. Licorice can not only harmonize the various drugs in this prescription, but also strengthen the qi-tonifying effect of ginseng and reduce the dryness of safflower and Chuanxiong, so it is a guiding drug.

[0027] The Chinese medicine composition for treating hair loss of the present invention has the effects of nourishing the liver and kidney, invigorating qi and activating blood circulation, has no obvious incompatibility contraindications, is used for preventing and treating hair loss, and promotes hair regeneration, and is particularly suitable for hair loss syndromes diagnosed as liver and kidney deficiency and deficiency of essence and blood in traditional Chinese medicine.

[0028] In a preferred embodiment, the Chinese medicine composition consists of the following components in parts by weight:

[0029] 15 parts of Cuscuta seeds, 15 parts of Polygonatum sibiricum, 10 parts of Ligusticum chuanxiong, 6 parts of Carthamus tinctorius, 10 parts of Ginsengs, 6 parts of Liquorice, and 15 parts of Polygonum multiflorum.

[0030] In a preferred embodiment, the dodder seed is salt dodder seed, the polygonatum is wine polygonatum, the chuanxiong is raw chuanxiong, the ginseng is raw sun-dried ginseng or codonopsis, the licorice is roasted licorice, and the polygonum multiflorum is processed polygonum multiflorum.

[0031] In a third aspect, the present invention provides a method for preparing the above-mentioned Chinese medicine composition for treating hair loss, comprising the following steps: weighing raw materials, decocting with water for 1-3 times, and combining the decoctions to obtain the Chinese medicine composition.

[0032] In a preferred embodiment, water is added each time and boiled for 1-3 hours, and the volume mass ratio of water to raw materials is 6-10 mL / g.

[0033] In a preferred embodiment, the raw materials are weighed and mixed, and then water is added and decocted for 1-3 times, and the decoctions are combined to obtain the traditional Chinese medicine composition.

[0034] In a preferred embodiment, after weighing the raw materials, mix the raw materials other than ginseng, add water and boil for 1-3 times, combine the decoctions to obtain extract 1; stew ginseng in water for 1-2 hours to obtain extract 2; and mix extract 1 and extract 2 to obtain the Chinese medicine composition.

[0035] In a fourth aspect, the present invention provides the use of the above-mentioned traditional Chinese medicine composition for treating hair loss in the preparation of a medicine having the effect of treating hair loss.

[0036] In a preferred embodiment, the pharmaceutical dosage form having the effect of treating hair loss is selected from decoction, tincture, granule, oral solution, tablet or capsule.

[0037] In a preferred embodiment, the granules are prepared by adding an appropriate amount of auxiliary materials to the traditional Chinese medicine composition, wherein the auxiliary materials are at least one of fillers, binders, wetting agents, disintegrants, lubricants and film coating materials; the oral liquid is prepared by adding an appropriate amount of preparation auxiliary materials to the traditional Chinese medicine composition; the preparation auxiliary materials are at least one of solvents, fragrances, flavoring agents, clarifiers and preservatives.

[0038] The beneficial effects of the present invention are:

[0039] 1. The present invention uses network pharmacology methods to screen and obtain a traditional Chinese medicine composition (cuscuta australis, polygonatum, ligusticum chuanxiong, safflower, ginseng, licorice, and polygonum multiflorum) for treating hair loss that can completely cover 288 hair loss-related targets. Compared with the existing technology, it uses fewer medicinal materials and covers more targets.

[0040] 2. The Chinese medicine composition for treating hair loss of the present invention uses Polygonum multiflorum as the main drug, Cuscuta australis and Polygonatum sibiricum as the auxiliary drugs, ginseng, safflower and Ligusticum chuanxiong as the adjuvant drugs, and liquorice as the guiding drug. The medicine is simple and powerful, and the whole formula has the effects of nourishing the liver and kidney, invigorating qi and activating blood circulation, and has no obvious incompatibility taboos. It is used to prevent and treat hair loss and promote hair regeneration, and is particularly suitable for hair loss syndromes diagnosed as liver and kidney deficiency and insufficient essence and blood in traditional Chinese medicine.

[0041] 3. The Chinese medicine composition for treating hair loss of the present invention has been proven to be safe and effective after clinical use. It can treat mild to moderate hair loss and reduce hair loss after 1 week, and relieve the symptoms of itchy and oily scalp. After 7-8 weeks of use, the patient has significant therapeutic effect, with a cure rate of up to 63.0%, an effective rate of up to 95.1%, and no rebound. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 Schematic diagram of the screening and validation process of Chinese herbal medicine compositions for treating hair loss;

[0043] Figure 2 Comparison of hair loss-related targets covered by different technical solutions;

[0044] Figure 3 Characteristic component diagram of the Chinese medicine composition for treating hair loss according to Example 2 of the present invention;

[0045] Figure 4 Comparison chart of a typical case before and after treatment of the Chinese medicine composition for treating hair loss according to Example 2 of the present invention;

[0046] Figure 5 Quantitative evaluation diagram of the efficacy of the Chinese medicinal composition for treating hair loss according to Example 2 of the present invention, A: patient self-rating (full score = 18); B: independent blind scoring by 3 dermatologists (full score = 3). DETAILED DESCRIPTION

[0047] It is worth noting that the raw materials used in the present invention are all common commercially available products, and their sources are not specifically limited.

[0048] Example 1 Screening method for Chinese medicine composition for treating hair loss

[0049] The screening method comprises the following steps:

[0050] 1) A total of 3457 articles on traditional Chinese medicine for the treatment of hair loss were collected through databases (Pubmed, EMBASE, CNKI, CSTJ and Wanfang), and 68 articles were obtained by removing duplicate articles and screening through abstracts. Twenty traditional Chinese medicines reported in the literature and confirmed to have the effect of promoting hair follicle growth by in vivo or in vitro experiments were selected, including Angelica dahurica, Nepeta tenuifolia, Platycladus orientalis, Angelica sinensis, Carthamus tinctorius, Ligusticum chuanxiong, Polygonatum sibiricum, Ginger, Ligustrum lucidum, Ligustrum lucidum, Astragalus, Ginseng, Coriander, Lygodium japonicus, Cuscuta australis, Rehmannia root, Rehmannia root, Polygonum multiflorum, Sophora flavescens, and Codonopsis pilosula were collected;

[0051] 2) With the help of the Chinese medicine system pharmacology database and analysis platform (https: / / tcmsp-e.com / index.php), HIT 2.0 Chinese herbal medicine component target analysis platform (http: / / hit2.badd-cao.net / ), and the Chinese medicine integrated pharmacology research platform (TCMIP), the active ingredients and targets of each of the above Chinese medicines were analyzed. The analysis results are shown in Tables 1-2 (the combination of active ingredients in Table 2 can completely cover 288 hair loss targets). The targets of 20 Chinese medicines were screened, and duplicate targets were removed to obtain a Chinese medicine target data set;

[0052] 3) Collect hair loss related targets through TTD, OMIM, and GeneCards disease databases to obtain a hair loss target dataset consisting of 14,171 hair loss related targets;

[0053] 4) Intersecting the Chinese medicine target dataset of step 2) with the hair loss target dataset of step 3) to obtain 288 hair loss related targets covered by the 20 hair growth Chinese medicines investigated (see Table 3, the same hair loss targets covered by the present invention);

[0054] 5) In order to achieve the goal of using the least amount of Chinese medicine to cover as many hair loss-related targets as possible, 20 Chinese medicines were screened, and Chinese medicines with the same active ingredients or the same targets were deleted, and Chinese medicines with more active ingredients or targets were retained. For example, β-sitosterol and stigmasterol in angelica and rehmannia are effective ingredients for treating hair loss, but safflower also contains other effective ingredients for treating hair loss in addition to β-sitosterol and stigmasterol, which can act on more hair loss targets. Therefore, only safflower was included in the formula without angelica and rehmannia; the 5 effective The ingredients can cover 6 hair loss related targets (GSK3B, ESR1, NCOA2, AR, AChE, PRSS1). Polygonum multiflorum can act on more hair loss targets besides these 6 hair loss targets. When formulating the prescription, only Polygonum multiflorum was included and black sesame was excluded. Through continuous comparison and analysis, the Chinese medicine composition for treating hair loss with the smallest formula that completely covers the above 288 hair loss related targets was finally screened out; the Chinese medicine composition for treating hair loss is a combination of Cuscuta chinensis, Polygonatum sibiricum, Ligusticum chuanxiong, Safflower, Ginseng, Licorice, and Polygonum multiflorum. The screening process is as shown in the attached Figure 1 shown.

[0055] Table 1 Number of active ingredients contained in 20 traditional Chinese medicines and number of hair loss targets they act on

[0056]

[0057] Table 2 Number of hair loss targets acted upon by each active ingredient

[0058] Chemical name Chemical name Chemical name Chemical name Chemical name Beta Carotene (11) Ginsenoside rh2(4) Physcion (1) Quercetin (69) Naringenin(16) Chuanxiong Naphtholide (3) Dioscin (8) Arachidonic acid (2) Rhein(47) Rhein (14) Isoflavones(6) Medi-Pterostilbene (10) Isorhamnetin (14) Kaempferol (31) Picea glycosides (18) Rhein (1) Sophora flavescens (4) Licorice flavonoids (10) Luteolin (23) Sesamin(18) Danthronone (1) Hedera hedera (8) Resveratrol (189) Baicalein(17) Matrine (8)

[0059] Table 3 Hair loss target information of the present invention and the prior art (CN110101781A, CN102210810A)

[0060]

[0061]

[0062] In addition, the targets of similar compositions in the prior art were statistically analyzed and compared with the Chinese medicine composition of the present invention, as follows:

[0063] Patent CN110101781A (referred to as "patent 1") discloses a Chinese herbal composition for hair growth and nourishment containing saffron, including seven Chinese medicinal herbs: "saffron, Platycladus orientalis leaves, Ligustrum lucidum fruit, Polygonum multiflorum, Cuscuta australis, Sophora flavescens, and Licorice". Theoretically, this combination can cover 314 targets, of which 283 targets are related to hair loss.

[0064] Patent CN102210810A (referred to as "patent 2") discloses a drug for treating hair loss, including 9 traditional Chinese medicines: "raw rehmannia, polygonum multiflorum, angelica, ligusticum chuanxiong, dodder seed, polygonatum sibiricum, liquorice, cooked rehmannia, and astragalus". Theoretically, it can cover 312 targets, of which 281 targets are related to hair loss.

[0065] The Chinese medicine composition of the present invention includes 7 Chinese medicinal herbs: Cuscuta chinensis, Polygonatum sibiricum, Ligusticum chuanxiong, Carthamus tinctorius, Ginseng, Licorice, and Polygonum multiflorum. Theoretically, it can cover 288 targets, and all 288 targets are related to hair loss. The hair loss-related targets covered by different technical solutions are shown in Table 3.

[0066] It can be seen that the number of Chinese medicinal herbs contained in the present invention is the same as that in "patent 1", but because it contains ginseng, polygonatum, and chuanxiong, it covers more hair loss-related targets (NR3C1, CASP1, ABCC2, RXRG, and PSMG1) than "patent 1"; the number of Chinese medicinal herbs contained in the present invention is less than that in "patent 2", but because it contains ginseng and safflower, it still covers more hair loss-related targets than "patent 2" (ALB, MDM2, PCNA, CASP1, CASP7, RXRG, and PSMG1), that is, the present invention uses the network pharmacology method to screen and obtain a Chinese medicinal composition for treating hair loss with the least number of Chinese medicinal herbs but the most hair loss-related targets (cuscuta, polygonatum, chuanxiong, safflower, ginseng, licorice, and polygonum multiflorum). The comparison of hair loss-related action targets covered by different technical schemes is detailed in the attached Figure 2 .

[0067] Example 2 Chinese medicine composition for treating hair loss

[0068] Prescription: 15 parts of salt dodder seeds, 15 parts of wine polygonatum, 10 parts of raw chuanxiong, 6 parts of safflower, 10 parts of raw sun-dried ginseng slices, 6 parts of roasted licorice, and 15 parts of processed polygonum multiflorum.

[0069] Here are the steps:

[0070] (1) weighing the raw materials according to the formula, mixing, adding water at a volume mass ratio of water to raw materials of 8 mL / g for decocting for 2 hours, centrifuging, and obtaining decoction 1 and medicinal residues;

[0071] (2) adding water to the residue in step (1) at a volume mass ratio of water to residue of 8 mL / g for a second decoction for 2 hours, and centrifuging to obtain decoction 2;

[0072] (3) combining decoction 1 and decoction 2 to obtain the traditional Chinese medicine composition for treating hair loss.

[0073] The effective ingredients of the Chinese medicine composition for treating hair loss of this embodiment were identified by HPLC-MS / MS method, mainly including baicalin, rhamnolide, kaempferol, luteolin, naringenin, quercetin and other ingredients. The specific characteristic ingredients are as follows: Figure 2 shown.

[0074] Example 3 Chinese medicine composition for treating hair loss

[0075] Prescription: 15 parts of salt dodder seeds, 15 parts of wine polygonatum, 10 parts of raw chuanxiong, 6 parts of safflower, 10 parts of codonopsis slices, 6 parts of roasted licorice, and 15 parts of processed polygonum multiflorum.

[0076] Here are the steps:

[0077] (1) weighing the raw materials according to the formula, mixing, adding water at a volume mass ratio of water to raw materials of 8 mL / g for decocting for 2 hours, centrifuging, and obtaining decoction 1 and medicinal residues;

[0078] (2) adding water to the residue in step (1) at a volume mass ratio of water to residue of 8 mL / g for a second decoction for 2 hours, and centrifuging to obtain decoction 2;

[0079] (3) combining decoction 1 and decoction 2 to obtain the traditional Chinese medicine composition for treating hair loss.

[0080] Example 4 Chinese medicine composition for treating hair loss

[0081] Prescription: 6 parts of salt dodder seeds, 12 parts of wine polygonatum, 8 parts of raw chuanxiong, 10 parts of safflower, 15 parts of raw sun-dried ginseng slices, 10 parts of roasted licorice, and 12 parts of processed polygonum multiflorum.

[0082] Here are the steps:

[0083] (1) weighing the raw materials according to the formula, mixing the raw materials other than the raw sun-dried ginseng, adding water at a volume mass ratio of water to the raw materials of 6 mL / g for decocting for 3 hours, centrifuging, and obtaining a decoction 1 and a medicinal residue;

[0084] (2) adding water to the medicinal residue in step (1) at a volume mass ratio of water to medicinal residue of 10 mL / g for a second decoction for 1 hour, centrifuging to obtain decoction 2; combining decoction 1 and decoction 2 to obtain extract 1;

[0085] (3) adding water to the raw sun-dried ginseng at a volume mass ratio of water to raw material of 8 mL / g, stewing for 1 h, and centrifuging to obtain extract 2;

[0086] (4) combining extract 1 and extract 2 to obtain the Chinese medicine composition for treating hair loss.

[0087] Application Examples

[0088] 1. Clinical trial: A clinical trial was conducted on the performance of the Chinese medicine composition for treating hair loss of Example 2.

[0089] Case selection: 81 patients with seborrheic alopecia and alopecia areata were selected, including 36 cases of mild alopecia (14 cases of mild grade 2, 22 cases of mild grade 3), 25 cases of moderate alopecia (11 cases of moderate grade 4, 14 cases of moderate grade 5), 16 cases of severe alopecia (13 cases of severe grade 6, 3 cases of moderate grade 7), and 4 cases of alopecia areata. The patients were 14-49 years old, and the disease course was half a month to 10 years.

[0090] According to the NORWOOD classification method commonly used at home and abroad, hair loss patients are divided into three types, mild, moderate and severe, and 1-7 stages. Mild level 1: sparse hair; Mild level 2: sparse hair on the top of the head, slight hair loss in the frontal corners; Mild level 3: sparse hair on the top of the head, obvious hair loss in the frontal corners; Moderate level 4: obvious hair loss on the top of the head, obvious M-shaped hair loss in the frontal corners; Moderate level 5: obvious hair loss in the frontal corners, sparse remaining hair in the center of the top; Severe level 6: complete hair loss in the frontal corners, with residual hair on the top; Severe level 7: complete hair loss in the frontal corners and complete hair loss on the top.

[0091] Dosage and administration: Take the Chinese medicine composition (decoction) for treating hair loss prepared in Example 2, take 200 ml each time, take twice a day, morning and evening, take it continuously for 8 weeks, observe the therapeutic effect every week, and record the therapeutic effect. The therapeutic results and effective time of the Chinese medicine composition for treating hair loss in Example 2 are shown in Table 4-5. The treatment standards are as follows:

[0092] Cure: The color and thickness of the new hair are consistent with the native hair, and the growth rate is normal. During the treatment period, the hair coverage rate reaches 60% of the treatment area, and it can still grow normally after stopping the medication.

[0093] Markedly effective: The color and thickness of the new hair are consistent with those of the patient's own hair and the growth rate is normal. During the treatment period, the hair coverage rate reaches 40% of the treated area and the hair can still grow normally after stopping the medication.

[0094] Effective: The color of the new hair is lighter than your own hair, the hair is finer and softer, the new hair is less dense, and the growth rate is normal. It can still grow normally after stopping the medication.

[0095] Ineffective: The new hair is white or reddish in color, has a fuzzy texture, most of the hair follicles are inactive, and the coverage is very poor.

[0096] Table 4 Treatment results of the Chinese medicine composition for treating hair loss in Example 2

[0097]

[0098] Table 5 Effect time of the Chinese medicine composition for treating hair loss in Example 2

[0099]

[0100] From Table 4-5, it can be seen that after the Chinese medicine composition for treating hair loss of the present invention (Example 2) was used for the treatment of 81 patients with seborrheic alopecia and alopecia areata, the cure rate was 63.0%, the total effective rate was 95.1%, and there were 4 ineffective cases, accounting for 4.9%. Most patients began to show significant effects 7-14 days after treatment, and the average effective time for patients with effective treatment was 19 days.

[0101] 2. Clinical trial: Conduct clinical trials on the performance of the Chinese medicine composition for treating hair loss in Example 3.

[0102] Case selection: 23 patients with seborrheic alopecia and alopecia areata were selected, including 14 cases of mild alopecia (9 cases of mild grade 2, 5 cases of mild grade 3), 4 cases of moderate alopecia (4 cases of moderate grade 4), 3 cases of severe alopecia (3 cases of severe grade 6), and 2 cases of alopecia areata. The patients were 16-46 years old, and the disease course was half a month to 10 years.

[0103] Dosage and administration: Take the Chinese medicine composition (decoction) for treating hair loss prepared in Example 3, take 200 ml each time, take twice a day in the morning and evening, take it continuously for 8 weeks, observe the therapeutic effect every week, and record the therapeutic effect. The therapeutic results and effective time of the Chinese medicine composition for treating hair loss in Example 3 are shown in Tables 6-7, and the treatment standard is the same as above.

[0104] Table 6 Treatment results of the Chinese medicine composition for treating hair loss in Example 3

[0105]

[0106] Table 7 Effective time of the Chinese medicine composition for treating hair loss in Example 3

[0107]

[0108] From Tables 6-7, it can be seen that after the Chinese medicine composition for treating hair loss of the present invention (Example 3) was used for the treatment of 23 patients with seborrheic alopecia and alopecia areata, the cure rate was 34.8%, the total effective rate was 87%, 3 cases were ineffective, accounting for 8.7%, and most patients began to show effects 7-35 days after treatment. The average effective time for patients with effective treatment was 32.9 days.

[0109] Compared with the Chinese herbal composition for treating hair loss of Example 3, the Chinese herbal composition for treating hair loss of Example 2 has higher efficacy (higher efficacy and significantly lower average effective time for effectively treated patients). It can be seen that in the Chinese herbal composition of the present invention, the use of raw sun-dried ginseng has better technical effects than Codonopsis pilosula.

[0110] 3. Clinical treatment experience

[0111] Case 1, female, 20 years old, stage 3 hair loss, hair loss for 1 year, first visit on June 27, 2023, took the Chinese medicine composition of Example 2 twice a day, after 1 week, the hair loss stopped significantly, the hair follicle openings bulged, the oiliness of the scalp decreased, and there was no obvious desquamation, itching, and redness and swelling of the scalp; after 2 weeks, new hair sprouted, the hair became shiny and elastic, the number of hair follicles gradually increased, and the oiliness of the scalp was not obvious; after about a month, the number of hairs gradually increased, and later one hair follicle increased from one hair to 2-4 hairs, the hair became thicker day by day, the production period and the resting period The follicles maintained a normal ratio, and the hair basically returned to normal.

[0112] Case 2, male, 22 years old, stage 2 hair loss, hair loss accompanied by desquamation and itching for 3 years, first visited the doctor on May 10, 2023, took the Chinese medicine composition of Example 2 twice a day, after 1 week, hair loss was reduced, hair follicle openings were bulging, scalp was mildly desquamated and itchy, but there was no obvious redness and swelling of the scalp; after 3 weeks, obvious new fine hairs could be seen on both sides of the frontal corners, and the number of hair follicles increased; after two months, the frontal corners on both sides became significantly longer and darker, the hair in the center of the top became significantly denser, and the itching and desquamation of the scalp basically subsided. Later, the number of hairs in one hair follicle increased from one to 2-4, the hair became thicker day by day, the growth phase and resting phase hair follicles maintained in a normal proportion, and the hair basically returned to normal.

[0113] Case 3, male, 40 years old, hair loss level 5, hair loss with oily scalp and scalp for 3 years, first visit on July 17, 2023, took the Chinese medicine composition of Example 2 twice a day, after 1 week, the hair loss was alleviated, the hair follicle opening was bulging, and the oiliness of the scalp was reduced,

[0114] Dandruff is reduced, but there is no obvious itching or redness on the scalp. After 2 weeks, new fine hairs can be seen on the forehead and top of the head, and the number of hair follicles gradually increases.

[0115] The oiliness of the hair is not obvious and the dandruff is mild. After 5 weeks, the hair on the forehead and top of the head becomes darker and thicker, and the number of hairs in a hair follicle increases from one to 2-4. The hair becomes thicker day by day, and the ratio of growing follicles to resting follicles is normal. The hair is obviously thicker than before.

[0116] Case 4, male, 26 years old, hair loss level 4, hair loss for 3 years, accompanied by oily head and face. First visit on July 21, 2023, the Chinese medicine composition of Example 2 was taken twice a day. After 1 week, the hair loss was alleviated, the hair follicle opening was bulging, the oiliness of the head was reduced, and there was no obvious itching and redness on the scalp; after 2 weeks, new fine hairs were visible on the forehead and top, the number of hair follicles gradually increased, the oiliness of the head was not obvious, and the dandruff was mild; about 1 month, the hair on the forehead and top became darker and thicker, the hair became thicker, the growth phase and the rest phase hair follicles maintained a normal ratio, and the hair was significantly thicker than before.

[0117] Typical cases 1-4: Comparison of treatment before and after oral administration of the Chinese medicine composition of Example 2 for 4-8 weeks. Figure 4It can be seen that after treatment, the hair loss situation in each typical case was greatly improved, with obvious new hair growth and an increase in the number of hair follicles.

[0118] 4. Quantitative evaluation of the efficacy of hair loss treatment

[0119] An 18-point questionnaire on hair loss efficacy satisfaction was designed to measure the improvement of hair loss range, hair growth, improvement of scalp sensitivity, degree of satisfaction with efficacy, and the presence or absence of adverse reactions (Table 8). 20 patients (half male and half female) were surveyed and scored. It was found that after 8 weeks of treatment (the Chinese medicine composition of Example 2), the patient satisfaction was significantly improved ( Figure 5 A); a 3-point scoring table (Table 9) was formulated according to the hair growth situation, and 3 dermatologists independently blindly scored the patient's pictures before and after treatment. After 8 weeks of treatment (the Chinese medicine composition of Example 2), the therapeutic effect of hair loss was significant ( Figure 5 B).

[0120] Table 8 18-point questionnaire on hair loss efficacy satisfaction

[0121]

[0122]

[0123] Table 9 3-point scoring table

[0124] Evaluate Score Significant reduction -3 Moderate reduction -2 Slightly reduced -1 No change 0 Slightly increase +1 Moderate increase +2 Significant increase +3

[0125] The solutions of the present invention are not limited to the technical means disclosed by the above technical means, but also include technical solutions composed of any combination of the above technical features. The above is a specific implementation of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications are also regarded as the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating hair loss, characterized in that: The Chinese medicine composition is composed of the following components in parts by weight: 6-15 parts of salt dodder seeds, 10-15 parts of wine polygonatum, 6-10 parts of raw chuanxiong, 6-10 parts of safflower, 6-15 parts of raw sun-dried ginseng, 6-10 parts of roasted liquorice, and 6-15 parts of processed polygonum multiflorum.

2. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is composed of the following components in parts by weight: 15 parts of salt dodder seeds, 15 parts of wine polygonatum, 10 parts of raw chuanxiong, 6 parts of safflower, 10 parts of raw sun-dried ginseng, 6 parts of roasted liquorice, and 15 parts of processed polygonum multiflorum.

3. The method for preparing the Chinese medicine composition for treating hair loss according to any one of claims 1 to 2, characterized in that: The method comprises the following steps: weighing raw materials, adding water and boiling for 1-3 times, and combining the boiling liquid to obtain the traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that: The raw materials are weighed, mixed, and boiled in water for 1-3 times, and the decoctions are combined to obtain the Chinese medicine composition; or the raw materials are weighed, raw materials other than ginseng are mixed, water is added and boiled for 1-3 times, the decoctions are combined to obtain extract 1, ginseng is stewed in water for 1-2 hours to obtain extract 2, and extract 1 and extract 2 are mixed to obtain the Chinese medicine composition; water is added and boiled for 1-3 hours each time, and the volume mass ratio of water to raw materials is 6-10mL / g.

5. Use of the Chinese medicinal composition for treating hair loss as claimed in any one of claims 1 to 2 in the preparation of a medicament for treating hair loss.

6. The use according to claim 5, characterized in that The pharmaceutical dosage form is selected from decoction, tincture, granule, oral solution, tablet or capsule.

7. The use according to claim 6, characterized in that The granules are prepared by adding an appropriate amount of auxiliary materials to the Chinese medicine composition, wherein the auxiliary materials are at least one of fillers, adhesives, wetting agents, disintegrants, lubricants and film coating materials; the oral liquid is prepared by adding an appropriate amount of preparation auxiliary materials to the Chinese medicine composition; the preparation auxiliary materials are at least one of solvents, aromatics, flavoring agents, clarifiers and preservatives.

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