WO2020042072A1

WO2020042072A1 - Traditional chinese medicine composition for treating alopecia, preparation method therefor and use thereof

Info

Publication number: WO2020042072A1
Application number: PCT/CN2018/103207
Authority: WO
Inventors: 管汾; 倪文澎; 束雅春; 吴旭彤; 傅静娟; 周琴妹; 罗会盛; 施洪
Original assignee: 江苏省中医院
Priority date: 2018-08-29
Filing date: 2018-08-30
Publication date: 2020-03-05
Also published as: CN108743907A

Abstract

Disclosed are a traditional Chinese medicine composition for treating alopecia, a preparation method therefor and the use thereof. The traditional Chinese medicine composition comprises the following parts by weight of raw materials: fleeceflower root 5-40, danshen root 5-40, milkvetch root 5-40, fortune's drynaria rhizome 5-40, safflower 5-40, malaytea scurfpea fruit 5-30, Gynostemma pentaphyllum 5-30, peach seed 5-40, zingiber 5-30, camphor 2-20, and hot pepper 2-15.

Description

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

Technical field

The invention relates to a traditional Chinese medicine composition for treating hair loss, a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine compounds.

Background technique

Alopecia is a common disease of dermatology and frequently occurs in the scope of diseases such as "alopecia areata" and "oil wind" in Chinese medicine. Clinically, it can be divided into alopecia areata, seborrheic alopecia, senile alopecia, chemotherapy-induced alopecia and other types. The incidence of alopecia areata and seborrheic alopecia is highest. The etiology of this disease is not clear so far, and may be related to the patient's own genetics, endocrine disorders, immune factors, neuropsychological factors, vascular dysfunction, infection, poisoning and so on.

Alopecia areata is a common chronic inflammatory disease that occurs in hair follicles. It has localized non-spotted patchy hair loss, and is associated with genetic, immune, bacterial, and fungal infections of pathogenic microorganisms, endocrine disorders, malnutrition, vascular dysfunction, and nervousness. And other factors. The onset of seborrheic alopecia is related to heredity, gonad endocrine disorders, excessive sebum secretion, microbial infections in hair follicles, and increased blood viscosity.

Western medicine is used for clinical treatment of alopecia (alopecia areata), such as glucocorticoids, cyclosporin A, mecobalamin, vitamin E, Xitoto ointment, and minoxidil have certain effects on hair loss. The treatment of seborrheic alopecia is mainly two types of hormone modulators and biological response modifiers. Hormonal regulators include androgen blockers and estrogen mediators, and biological response regulators include minoxidil and retinoids. The treatment of alopecia areata is mainly an immunomodulator and a biological response modifier, which non-specifically stimulate hair growth. Immunomodulators include corticosteroids, topical immunotherapy for contact sensitization, dithranol and the like. Biological response modifiers are mainly 2% minoxidil solutions. However, these drugs have relatively large toxic and side effects and are not suitable for long-term use in patients with hair loss. There are also some patients who have used hair transplantation to achieve certain results.

Traditional Chinese medicine has certain clinical effects. Traditional Chinese medicine treats hair loss on the basis of dialectical treatment. It has the advantages of significant effects, little or no toxic side effects, and no drug dependence. Traditional Chinese medicine believes that the cause and pathogenesis of hair loss are as follows: The earliest records of hair loss Seen in the "Inner Canon", it is called hair plucking, hair fall, hair fall. Traditional Chinese medicine believes that "hair is not only blood, but kidneys." "The Pathology of Various Pathogens" states: "The pulse of Ren is the sea of twelve classics, the sea of blood, and the upper lip of the mouth must be in contact with the blood. If the blood is rich, it must be beautiful, and it must be beautiful; Rong Run, she must be bald. "All of the above shows that hair growth depends on qi, blood, and fineness. Because "qi runs but blood goes", "qi can produce blood", "qi is not consumed, it is attributed to the kidney and refined; essence is not leaked, it is attributed to the liver and the blood is cleared." It can be seen that the hair grows gloomy and viscera. Qi and blood are closely related. Some modern doctors believe that poisonous evils (wind, dampness, heat) are confined, blood stasis and obstruction are the etiology and pathology of hair loss, and detoxification and collaterals are their treatments. After eating fat and burning, drinking gluttonous liquor, sitting more and moving less, using God too much, hurting the heart and spleen, dying blood or stagnation of fire, endogenous fever, and kidney water damage are the causative factors. Poisonous stasis Damage to the network, hair stagnation, hair root loss of honor are its pathological changes.

However, with the development of society, the causes of hair loss are becoming more and more complicated. For example, hair loss is not only caused by imagination, but also is caused by an increase in mental stress and an imbalance of diet caused by imbalance of hair. Therefore, the corresponding treatment methods and principles also need to be further improved.

Summary of the Invention

Object of the invention: In view of the above technical problems, the present invention provides a traditional Chinese medicine composition for treating hair loss, and a preparation method and application thereof. The compound composition has the effect of stimulating hair growth and has a significant effect.

Technical solution: In order to achieve the above-mentioned object of the invention, the technical solution adopted by the present invention is as follows:

A traditional Chinese medicine composition for treating hair loss, which comprises the following raw materials in parts by weight:

5 to 40 servings of Polygonum multiflorum, 5 to 40 servings of Salvia miltiorrhiza, 5 to 40 servings of Astragalus, 5 to 40 servings of broken bone, 5 to 40 servings of safflower,

5-30 parts of psoralen, 5-30 parts of Gynostemma, 5-40 parts of peach kernels, 5-30 parts of dried ginger, 2-20 parts of camphor,

2-15 servings of pepper.

Preferably, the traditional Chinese medicine composition for treating hair loss includes the following raw materials in parts by weight:

15-30 parts of Polygonum multiflorum, 15-30 parts of Salvia miltiorrhiza, 15-30 parts of Astragalus, 15-30 parts of bone broken supplement, 15-30 parts of safflower,

10-20 parts of psoralen, 10-20 parts of Gynostemma, 15-30 parts of peach kernels, 10-20 parts of dried ginger, 5-15 parts of camphor,

5-10 servings of pepper.

The preparation method of the traditional Chinese medicine composition for treating hair loss includes the following steps:

(1) Take the peppers and cut them into pieces. Take the Radix Polygoni Radix Salviae, Astragalus Root, Bone Broken Tonic, Psoralen, Gynostemma, Peach Kernel, and Dried Ginger Bawei. After mixing, crush it into coarse powder. Take the coarse powder and safflower to obtain a mixed powder. ,spare;

(2) Take the crushed pepper and immerse it with a 60-80% ethanol aqueous solution for 14-16 days; take the above mixed powder and immerse it with a 60-80% ethanol aqueous solution for 14-16 days, filter the two extracts, and combine them. Allow to stand and filter to obtain the filtrate;

(3) The filtrate is concentrated and prepared with camphor and pharmaceutically acceptable excipients.

The impregnations in step (2) were all impregnated under a closed condition.

Stir once a day during the pepper dipping after crushing in step (2).

During the impregnation of the mixed powder in step (2), stirring is performed once a day.

The preparation in step (3) is a tincture, a spray, an ointment, a cream, a patch, a plaster, a coating, a tincture, or a film coating agent.

Application of the traditional Chinese medicine composition in preparing medicine for treating hair loss.

According to the internal organs theory, the cause of hair loss is still liver and kidney deficiency, with blood stasis, blood heat, and damp heat as the standard. However, the disease is mostly mixed with deficiency or empirical evidence. With changes in the external environment such as social development, work rhythm, and lifestyle, hair loss is not only caused by deficiency, but also due to increased mental stress and imbalanced diet. A hair loss caused by a combination of deficiency and solidness. Treatment of hair loss should start with Qi, blood, liver, kidney, heart, and spleen. Nourishing blood and growing hair can run through, depending on the type of syndrome, or nourishing the yin of the liver and kidney to produce yin and blood; Active, in addition to the symptoms can be added and subtracted with the card.

Therefore, the present invention selects raw materials according to the pathogenesis of hair loss and the theory of traditional Chinese medicine. The traditional Chinese medicine compound of the present invention has the effects of nourishing liver and kidney, detoxifying and expelling wind, replenishing solid hair, activating blood, nourishing blood, renewing vital energy, refreshing qi and collaterals, and stimulating The effect of hair growth. Polygonum multiflorum, Salvia miltiorrhiza, Astragalus membranaceus, Bone broken tonic, Safflower, Psoralen, Gynostemma pentaphylla, peach kernel, dried ginger, camphor, and pepper are used as raw materials to prepare a traditional Chinese medicine prescription for treatment.

The basis of the raw materials selected in the present invention are: Polygonum multiflorum tonicate liver and kidney, detoxify and expel wind, and be the main drug; bone fragmentation, psoralen, astragalus, gypenosides, kidney and marrow, Yizhong Gufa; safflower, salvia, Dry ginger, activating blood and nourishing blood and regenerating new blood; camphor and chili are used for qi and collaterals, combined with various medicines, tonifying liver and kidney, detoxifying and expelling wind, benefiting from solid hair, activating blood and nourishing and stimulating blood, qi and activating collaterals, topical treatment All kinds of hair loss and stimulation of hair growth have good effect.

With the above-mentioned Chinese medicine, the raw materials and scientifically matched raw materials are selected based on science. The components can coordinate and promote each other, play a synergistic effect, and have a good effect on stimulating hair growth.

Application of the traditional Chinese medicine compound for treating hair growth stimulating in the invention in the preparation of a medicine for treating hair loss. After many years of clinical verification, the traditional Chinese medicine compound medicine of the present invention has the effect of stimulating hair growth.

Wherein, the medicines include medicines of various dosage forms made by combining traditional Chinese medicine compound with stimulating hair growth and pharmaceutically acceptable excipients. The dosage forms are tinctures, sprays, ointments, creams, patches, patches Agents, plasters, coatings, tinctures, or coatings.

When the traditional Chinese medicine compound for stimulating hair growth and used for treating hair loss according to the present invention is prepared into tincture, the extract of the raw material of the traditional Chinese medicine compound is added to an ethanol solution to a formula amount to prepare a tincture.

When the traditional Chinese medicine compound for stimulating hair growth is used to treat hair loss, the extract of the raw material of the traditional Chinese medicine compound and suitable auxiliary materials such as a solvent, a cosolvent, an antioxidant, a bacteriostatic agent, a surfactant, etc. The additive is filled in a special device to make a spray.

When the traditional Chinese medicine compound for stimulating hair growth and used for treating hair loss according to the present invention is made into an ointment, the extract of the raw material of the traditional Chinese medicine compound is mixed with a suitable oily or water-soluble base to prepare an ointment.

When the traditional Chinese medicine compound for stimulating hair growth for treating hair loss according to the present invention is made into a cream, the extract of the raw material of the traditional Chinese medicine compound is dissolved or dispersed in an emulsion-type matrix to form a uniform semi-solid preparation to make a cream.

When the traditional Chinese medicine compound for stimulating hair growth is used for treating hair loss, the extract of the traditional Chinese medicine compound raw material is dissolved in a solvent, and suitable surfactants, emulsifiers, humectants, and bacteriostatic agents are added. , Antioxidant or transdermal absorbent, etc., with suitable materials such as aluminum foil-polyethylene composite film, release paper, ethylene-vinyl acetate copolymer acrylic or polyisobutylene pressure-sensitive adhesive, silicone rubber and polyethylene glycol, etc. Made into a patch.

When the traditional Chinese medicine compound for stimulating hair growth is used for treating hair loss, the extract of the raw material of the traditional Chinese medicine compound and a suitable base are made into a paste and coated on a backing material to make a paste. Cream.

When the traditional Chinese medicine compound for stimulating hair growth for treating hair loss according to the present invention is made into a coating agent, the extract of the raw material of the traditional Chinese medicine compound is made into a coating agent with a solvent such as ethanol, vegetable oil, glycerin and the like.

When the traditional Chinese medicine compound for stimulating hair growth is used for treating hair loss, when the tincture is made into tincture, the extract of the raw material of the traditional Chinese medicine compound and ethanol, oil or a suitable solvent are used to make a tincture.

When the traditional Chinese medicine compound for stimulating hair growth of the present invention for treating hair loss is made into a film coating agent, the extract of the raw material of the traditional Chinese medicine compound is dissolved or dispersed in a solvent containing a film-forming material to prepare a film coating agent.

Beneficial effect; Compared with the prior art, the traditional Chinese medicine compound with the effect of stimulating hair growth provided by the present invention has the following advantages:

1. The traditional Chinese medicine compound for stimulating hair growth of the present invention for the treatment of hair loss. According to the theory of traditional Chinese medicine and the pathogenesis of hair loss, the combination of raw materials is selected, and the distribution ratio of each group is scientific and reasonable. Clinical observation research shows that the traditional Chinese medicine of the present invention The compound has the effect of stimulating hair growth, has the effect of treating hair loss, and has no adverse effects in long-term use.

2. The traditional Chinese medicine compound preparation method of the present invention has reasonable process design, no organic solvent is used in the preparation process, no pollution, and large-scale industrial production can be realized.

3. The traditional Chinese medicine compound for treating hair loss according to the present invention can be conveniently and pharmaceutically acceptable excipients prepared into various dosage forms of medicines, which is convenient to use.

detailed description

The technical solution according to the present invention will be further described in detail through specific embodiments.

Example 1

Drug composition:

Polygonum multiflorum 22g, Salvia miltiorrhiza 23g, Astragalus 23g, Bone broken supplement 22g, Safflower 22g,

Psoralen 17g, Gynostemma 18g, Peach Kernel 22g, Dried Ginger 17g, Camphor 11g,

9g chili

Preparation:

(1) Take the peppers and cut them into pieces. Take the Radix Polygoni Radix Salviae Root, Radix Astragali, Gusuibubu, Psoralen, Gynostemma, Peach Kernel and Dried Ginger Bawei, mix and crush them into coarse powder, mix the coarse powder with safflower and set aside.

(2) Take the crushed peppers, place them in an impregnated bucket with a lid, add an appropriate amount of 70% ethanol solution, soak them in a tight lid for 15 days, stir once a day during the period, and filter out the appropriate amount of the extract; Cover the immersion tank with a 70% ethanol solution and immerse it for 15 days. Stir once a day during the period, filter the leaching solution, combine the leaching solutions, let stand for 24 hours, and filter to obtain the filtrate.

(3) Take the filtrate to concentrate, take another camphor, dissolve it with an appropriate amount of ethanol, add it to the filtrate, add 70% ethanol to the total amount, and stir well. Strained, packed and packed after filtering to obtain tincture.

Example 2

Drug composition:

Polygonum multiflorum 5g, Salvia miltiorrhiza 5g, Astragalus 5g, Bone broken supplement 5g, Safflower 5g,

Psoralen 5g, Gynostemma 5g, Peach Kernel 5g, Dried Ginger 5g, Camphor 2g,

2g chili

Preparation:

(2) Take the crushed peppers, place them in an impregnated bucket with a lid, add an appropriate amount of 60% ethanol solution, soak them in a tight lid for 16 days, stir once a day during the period, and filter out the appropriate amount of extract; Add a suitable amount of 60% ethanol in the lid to the immersion tank, and immerse it in a tight lid for 16 days, stirring once a day during the period, filtering the leaching solution, combining the leaching solutions, leaving them for 24 hours, filtering, and obtaining the filtrate.

(3) Take the filtrate to concentrate, and take camphor, and fill it with suitable auxiliary materials such as solvents, co-solvents, antioxidants, bacteriostatic agents, surfactants and other additives in a special device to make a spray.

Example 3

Drug composition:

Polygonum multiflorum 40g, Salvia miltiorrhiza 40g, Astragalus 40g, Bone broken supplement 40g, Safflower 40g,

30g psoralen, 30g gynostemma, 40g peach, 30g dried ginger, 20g camphor,

15g chili

Preparation:

(2) Take the crushed peppers, place them in an impregnated bucket with a lid, add an appropriate amount of 80% ethanol solution, and immerse them in a tight lid for 14 days. Stir once a day during the period, and filter out the appropriate amount of extract. Cover the immersion tank with an appropriate amount of 80% ethanol solution, and immerse it tightly for 14 days. Stir once a day during the period, filter the leaching solution, combine the leaching solutions, let stand for 24 hours, and filter to obtain the filtrate.

(3) The filtrate is concentrated, and the other camphor is dissolved and dispersed together in an emulsion-type matrix to form a uniform semi-solid preparation to prepare a cream.

Example 4

Drug composition:

Polygonum multiflorum 15g, Salvia miltiorrhiza 15g, Astragalus 15g, Bone broken supplement 15g, Safflower 15g,

Psoralen 10g, Gynostemma 10g, Peach Kernel 15g, Dried Ginger 10g, Camphor 5g,

5g chili

Preparation:

(2) Take the crushed peppers, place them in a immersion bucket with a lid, add an appropriate amount of 70% ethanol solution, and immerse them in a tight lid for 14 days. Stir once a day during the period, and filter out the appropriate amount of the extract. Add the appropriate amount of 70% ethanol in the lid to the immersion tank, and immerse it tightly for 16 days. Stir once a day during the period, filter the leaching solution, combine the leaching solutions, leave it for 24 hours, and filter to obtain the filtrate.

(3) Concentrate the filtrate, dissolve the other camphor, and dissolve it in the solvent together, add suitable surfactants, emulsifiers, humectants, bacteriostatic agents, antioxidants or transdermal absorbers, etc., with suitable materials such as aluminum foil -Polyethylene composite film, release paper, ethylene-vinyl acetate copolymer acrylic or polyisobutylene pressure-sensitive adhesive, silicone rubber and polyethylene glycol, etc., to make patches.

Example 5

Drug composition:

Polygonum multiflorum 30g, Salvia miltiorrhiza 30g, Astragalus 30g, Bone broken supplement 30g, Safflower 30g,

Psoralen 20g, Gynostemma 20g, Peach Kernel 30g, Dried Ginger 20g, Camphor 15g,

10g chili

Preparation:

(2) Take the crushed peppers, place them in a immersion bucket with a lid, add an appropriate amount of 70% ethanol solution, and immerse them in a tight lid for 16 days. Stir once a day during the period, and filter out the appropriate amount of extract. Cover the immersion tank with an appropriate amount of 70% ethanol solution, and immerse it tightly for 14 days. Stir once a day during the period, filter out the leachate, combine the leachate, leave it for 24 hours, and filter to obtain the filtrate.

(3) The filtrate is concentrated, and the other camphor is dissolved and dispersed together in a solvent containing a film-forming material to prepare a coating agent.

Clinical trial of Chinese traditional medicine composition for treating hair loss:

The experimental design was based on the principle of medicinal machine control, which was randomly divided into 71 cases in the treatment group (growth cyanosis group) and 42 cases in the control group (2% minedin group) for comparison of efficacy.

I. Diagnostic criteria:

1. The skin lesions are round or irregular hair loss plaques, the plaques vary in size and size, the edges are clear, the surface is smooth without inflammation, and there are no conscious symptoms.

2. Hair loss plaques can expand on their own, or several pieces can be fused into large hair loss.

3. The course of the disease is slow, and it can be taken off as long as you recover.

Case selection

1. Selection criteria:

(1) Outpatient male and female patients, meeting the diagnostic criteria for flecks, aged 12-70 years;

(2) The patient agreed to participate in the observation and cooperated closely.

2.Exclusion criteria:

(1) Pregnant or lactating women:

(2) Those who take oral alopecia areata or other topical alopecia areata;

(3) Those who do not follow the doctor's orders.

Treatment options:

1. The treatment group uses external preparations (such as tinctures and creams) prepared by the present invention, and rubs the affected area with cotton swabs twice daily. Observe every two weeks and record the efficacy and side effects. Two weeks is a course of treatment, and four consecutive courses are observed to determine the efficacy.

2. The control group was treated with 2% chlorhexidine.

4. Efficacy and safety evaluation standards

1. Efficacy evaluation standards:

Clinical symptoms and signs were performed on a 4-point scale, that is, 0 = none, 1 = mild, 2 = moderate, and 3 = severe.

Cure: The non-skid hairs at the hair loss area are completely grown without new hair loss spots. The curative effect index is 100%, and the symptom score is 0.

Significant effect: more hair growth at the hair loss site. There were no new hair loss spots, the efficacy index was> 70%, and the symptom score was 1. Improvement: Hair loss hair growth occurred at the hair loss site, and no new hair loss spots appeared. Efficacy index> 30%, symptom score is 2.

Ineffective: less hair growth, or new hair loss spots again, efficacy index <30%, symptom score of 3.

Efficacy index = (points before treatment-points after treatment) / points before treatment * 100%

The total effective rate is based on recovery plus marked effect.

2.Safety assessment standards

Level 1: Safe, without any adverse reactions

Level 2: It is relatively safe. If there is any adverse reaction, the drug can be continued without any treatment.

Level 3: There are safety issues, moderate levels, and adverse reactions can be continued after treatment.

Level 4: The trial was terminated due to adverse reactions.

3. Judgment criteria for the degree of adverse events

Mild: Subject can tolerate, does not affect treatment, does not require special treatment, and has no impact on subject's recovery;

Moderate: Subjects are intolerable, need to withdraw the drug to terminate the experiment or do special treatment, which has a direct impact on the subject's recovery; Severe: endanger the subject's life, cause death or disability, and need to withdraw the drug or urgent treatment immediately.

V. Statistical Analysis: The results are as follows

Table 1 Comparison of efficacy between treatment group and control group (%)

Note: There is a significant difference in the total effective comparison chi-square test P <0.01

From the results in the table above, the effective rate of the treatment group was significantly greater than that of the control group, and no side effects such as folliculitis and allergies occurred during the treatment.

Claims

A Chinese medicinal composition for treating hair loss, characterized in that it comprises the following raw materials in parts by weight:

5 to 40 servings of Polygonum multiflorum, 5 to 40 servings of Salvia miltiorrhiza, 5 to 40 servings of Astragalus, 5 to 40 servings of broken bone, 5 to 40 servings of safflower,

5-30 parts of psoralen, 5-30 parts of Gynostemma, 5-40 parts of peach kernels, 5-30 parts of dried ginger, 2-20 parts of camphor,

2-15 servings of pepper.
The Chinese medicine composition for treating hair loss according to claim 1, characterized in that it comprises the following raw materials in parts by weight:

15-30 parts of Polygonum multiflorum, 15-30 parts of Salvia miltiorrhiza, 15-30 parts of Astragalus, 15-30 parts of bone broken supplement, 15-30 parts of safflower,

10-20 parts of psoralen, 10-20 parts of Gynostemma, 15-30 parts of peach kernels, 10-20 parts of dried ginger, 5-15 parts of camphor,

5-10 servings of pepper.
The method for preparing a Chinese medicine composition for treating hair loss according to any one of claims 1-2, comprising the following steps:

(1) Take the peppers and cut them into pieces. Take the Radix Polygoni Radix Salviae, Astragalus Root, Bone Broken Tonic, Psoralen, Gynostemma, Peach Kernel, and Dried Ginger Bawei. After mixing, crush it into coarse powder. Take the coarse powder and safflower to obtain a mixed powder. ,spare;

(2) Take the crushed pepper and immerse it with a 60-80% ethanol aqueous solution for 14-16 days; take the above mixed powder and immerse it with a 60-80% ethanol aqueous solution for 14-16 days, filter the two extracts, and combine them. Allow to stand and filter to obtain the filtrate;

(3) The filtrate is concentrated and prepared with camphor and pharmaceutically acceptable excipients.
The method for preparing a traditional Chinese medicine composition for treating hair loss according to claim 3, wherein the impregnation in step (2) is all impregnated under a closed condition.
The method for preparing a Chinese medicine composition for treating hair loss according to claim 3, characterized in that, in step (2), the pepper is stirred once a day during the dipping of the pepper.
The method for preparing a traditional Chinese medicine composition for treating hair loss according to claim 3, characterized in that, during the impregnation of the mixed powder in step (2), stirring is performed once a day.
The method for preparing a Chinese medicine composition for treating hair loss according to claim 3, wherein the preparation in step (3) is an elixir, a spray, an ointment, a cream, a patch, a plaster, a coating agent, Tincture or coating agent.
Application of the Chinese medicinal composition according to any one of claims 1-2 in the preparation of a medicine for treating hair loss.