CN115120698A

CN115120698A - A topical Chinese medicinal composition for preventing alopecia, and its preparation method

Info

Publication number: CN115120698A
Application number: CN202211045464.5A
Authority: CN
Inventors: 李京; 常宇; 杨茗茜
Original assignee: Liaoning University of Traditional Chinese Medicine
Current assignee: Liaoning University of Traditional Chinese Medicine
Priority date: 2022-08-30
Filing date: 2022-08-30
Publication date: 2022-09-30
Anticipated expiration: 2042-08-30
Also published as: CN115120698B

Abstract

The invention relates to the field of traditional Chinese medicines, in particular to an external traditional Chinese medicine composition for preventing alopecia and a preparation method thereof. The invention provides an external traditional Chinese medicine composition for preventing alopecia, which comprises the following components: radix sophorae flavescentis, cortex dictamni, fructus kochiae, cacumen biotae, folium mori, rhizoma smilacis glabrae, radix stemonae, pinellia ternate, rhizoma acori graminei, rhizoma atractylodis, ligusticum wallichii, angelica sinensis, caulis spatholobi, safflower, cortex moutan, radix paeoniae rubra, lithospermum, radix sileris, notopterygium root, fructus viticis, radix angelicae, plantain herb, rhizoma alismatis, herba ecliptae, polygonum multiflorum, radix bupleuri, cassia twig, rhizoma zingiberis, pepper, fructus psoraleae, herba epimedii, liquorice and mint. The tincture prepared by the invention has the effects of removing heat and drying dampness, nourishing liver and kidney, promoting blood circulation to remove blood stasis, fixing hair and preventing alopecia, is simple in preparation method and obvious in effect, belongs to a pure traditional Chinese medicine external preparation, does not damage liver and kidney functions, and is good in safety evaluation.

Description

A topical Chinese medicinal composition for preventing alopecia, and its preparation method

Technical Field

The invention relates to the field of traditional Chinese medicines, in particular to an external traditional Chinese medicine composition for preventing alopecia and a preparation method thereof.

Background

Alopecia is a common disease in modern clinical practice, is mostly seen in young and strong men, and is mainly manifested by gradual upward movement of hair lines on two sides of forehead and temples, and sparse hair on the top of the head, or even shedding, which seriously affects physical and mental health and daily work and study of patients, so in recent years, experts in multiple disciplines and multiple fields develop a series of deep discussion and research on the disease. Modern medicine does not clearly describe the etiology and pathogenesis of the disease, and is considered to be closely related to factors such as immunity, heredity, hormone use, local inflammation, internal environment of nerves and the like. In addition, mental anxiety, dietary disorders, and bacterial infections can also induce or aggravate the condition. Aiming at the disease, the clinical treatment is very troublesome, the medicine such as finasteride tablets, minoxidil tablets and the like is usually taken for oral treatment, and the serious patient can be treated by autologous hair follicle transplantation. Although effective to some extent, long-term effective therapeutic goals have not been achieved.

Alopecia belongs to the category of diseases such as tinea moths and tinea, alopecia moths and the like in traditional Chinese medicine, the ancient tracing is carried out, the records about the alopecia are firstly recorded in postnatal clearing book of surgery syndrome treatment, and the pathogenesis of the alopecia can be summarized as that the alopecia is caused by eating fatty and sweet taste longitudinally, or causing emotional failure to dissipate fire, or causing labor and effort to consume blood, or steaming at the vertex due to rheumatic fever. The circulation of qi and blood is obstructed, the clear orifices are not nourished by the soft, the hair is not solid, the hair roots are empty and the hair is dropped. In conclusion, the hair loss occurs in the liver, spleen and kidney, which are closely related, the liver, kidney and spleen deficiency is the main cause, the wind, dampness and heat beat are the secondary cause, and the disease nature is characterized by intermingled deficiency and excess.

Because the alopecia is complicated and the disease course is prolonged, the clinical prevention and treatment work at the present stage faces huge challenges, so that the adoption of active and effective treatment schemes and measures is of great importance in improving clinical symptoms, slowing down the disease course and improving the life quality.

Disclosure of Invention

The invention improves and optimizes the prior prescription on the medicament dosage form, develops the traditional Chinese medicine hair-strengthening external preparation with high efficiency and small side effect and treats patients in a mode of hair-strengthening external preparation.

In principle, the traditional Chinese medicine theory and modern pharmacological research are combined to screen out traditional Chinese medicine components with the functions of resisting bacteria and diminishing inflammation, improving the activity of hair follicles and promoting the growth and development of hairs.

In the aspect of prescription medication, the specific medicinal herbs with the effects of removing heat and drying dampness, nourishing liver and kidney, cooling blood and nourishing yin, activating blood and dissolving stasis, nourishing blood and promoting tissue regeneration are selected by utilizing the four-qi five-flavor, nature and channel tropism and the main efficacy of the medicaments.

The medicine used in the whole formula has comprehensive efficacy and definite curative effect, is focused on pathogenesis, covers almost all syndrome types clinically related to alopecia through the whole processes of alopecia occurrence, development and prognosis, and is the specific practice of traditional Chinese medicine prevention and treatment concepts such as 'strengthening body resistance and eliminating evil', 'giving consideration to the symptoms and root causes', and 'treating the whole body'.

In order to achieve the above object, the present invention provides the following technical solutions.

The invention provides an external traditional Chinese medicine for treating alopecia, which comprises the following components in parts by weight: 10-20 parts of radix sophorae flavescentis, 10-30 parts of cortex dictamni, 10-20 parts of fructus kochiae, 15-30 parts of cacumen biotae, 15-30 parts of folium mori, 15-20 parts of rhizoma smilacis glabrae, 10-15 parts of radix stemonae, 10-15 parts of pinellia ternate, 15-20 parts of rhizoma acori graminei, 10-30 parts of rhizoma atractylodis, 10-25 parts of ligusticum wallichii, 10-25 parts of angelica sinensis, 10-25 parts of caulis spatholobi, 10-25 parts of safflower carthamus, 10-20 parts of moutan bark, 10-20 parts of radix paeoniae rubra, 10-20 parts of lithospermum, 10-20 parts of radix saposhnikoviae, 10-30 parts of notopterygium root, 10-30 parts of fructus viticis, 10-25 parts of radix angelicae, 10-25 parts of plantain, 10-30 parts of rhizoma alismatis, 10-30 parts of eclipta, 10-30 parts of polygonum multiflorum, 10-25 parts of radix bupleuri, 10-20 parts of cassia twig, 10-25 parts of rhizoma zingiberis, 5-15 parts of pepper, 10-30 parts of fructus psoraleae, 10-30 parts of herba epimedii, 10-20 parts of liquorice and 10-25 parts of mint.

The external traditional Chinese medicine for treating alopecia is preferably prepared from the following components in parts by weight: 15g of radix sophorae flavescentis, 15g of cortex dictamni, 15g of fructus kochiae, 15g of cacumen biotae, 15g of folium mori, 20g of rhizoma smilacis glabrae, 15g of radix stemonae, 10g of pinellia ternate, 15g of rhizoma acori graminei, 15g of rhizoma atractylodis, 15g of ligusticum wallichii, 15g of angelica sinensis, 15g of caulis spatholobi, 10g of safflower, 15g of cortex moutan radicis, 15g of radix paeoniae rubra, 10g of lithospermum, 15g of radix saposhnikoviae, 15g of notopterygium root, 15g of fructus viticis, 15g of radix angelicae, 15g of plantain herb, 15g of rhizoma alismatis, 15g of herba ecliptae, 15g of polygonum multiflorum, 15g of radix bupleuri, 10g of cassia twig, 15g of rhizoma zingiberis, 10g of pepper, 15g of fructus psoraleae, 15g of herba epimedii, 15g of liquorice and 12g of mint.

The invention provides a preparation method of an external traditional Chinese medicine for treating alopecia, which comprises the steps of soaking traditional Chinese medicine decoction pieces in 300ml of 75% alcohol for two weeks, discarding dregs of a decoction, and pouring supernatant liquor to obtain the external traditional Chinese medicine.

The traditional Chinese medicine composition is used for preparing medicines with the effects of removing heat and drying dampness, nourishing liver and kidney, promoting blood circulation to remove blood stasis and fixing hair and preventing alopecia.

Furthermore, the dosage form of the traditional Chinese medicine composition is tincture.

Furthermore, the tincture is used for wiping the alopecia local, the clinical dosage is calculated according to the body weight of a human body, and 0.035g of the medicine is used for 1 kg of the body weight for each time, and 2 times/day is used.

The pharmacological effects of the raw materials of the invention are as follows.

According to the traditional Chinese medicine, alopecia is closely related to liver and kidney deficiency, damp-heat fumigation, phlegm-blood stasis and blood heat wind dryness, and the nature of the alopecia is mostly the syndrome of intrinsic deficiency and secondary excess. Firstly, the hair is the rest of blood, the essence and blood are homologous, the liver and kidney are deficient, the water is deficient, the wood is depressed, the hair roots are empty, and the hair loses the source of nourishing, so the hair is withered and easy to lose, and the hair is treated as nourishing the liver and kidney, nourishing the blood and replenishing the essence, and fundamentally cultivating and nourishing. Secondly, pathogenic factors are marked by damp-heat and blood-heat fumigating and transpiring, heat is transformed into dryness for a long time, wind is extremely generated, the head is positioned at the position of yang, the head is positioned at the vertex of the human body, and is easy to be attacked by wind evil, such as wind-blowing leaf fall and hair streak is not floated, so that the traditional Chinese medicine can treat the aspects of removing heat and drying dampness, nourishing liver and kidney, cooling blood and nourishing yin, promoting blood circulation and removing blood stasis, nourishing blood and promoting tissue regeneration and the like, eliminate pathogenic factors and strengthen the body resistance and prevent alopecia. In addition, because the alopecia disease is mainly on the body surface skin and is easy to be progressively aggravated, the external traditional Chinese medicine preparation is adopted to wipe the affected part, the treatment target that the medicine effect directly reaches the focus can be realized, and the external preparation can perfectly accord with the long-term local treatment requirement.

The traditional Chinese medicine composition is prepared from lightyellow sophora root, densefruit pittany root-bark, broom cypress fruit, arborvitae tops, mulberry leaf, safflower, tree peony bark, red paeony root, yerbadetajo herb, tuber fleeceflower root and the like, and the compatibility of the whole formula is strict, and the lightyellow sophora root, the densefruit pittany root-bark, glabrous greenbrier rhizome, broom cypress fruit and sessile stemona root are taken as monarch medicines; chinese angelica, suberect spatholobus stem, safflower, Szechuan lovage rhizome, tree peony bark, red paeony root and Chinese arborvitae twig are taken as ministers; radix Arnebiae, radix Angelicae Dahuricae, fructus Vitics Simplicifoliae, herba Menthae, radix Saposhnikoviae, Notopterygii rhizoma, rhizoma Pinelliae, rhizoma Acori Graminei, and rhizoma Atractylodis as adjuvants; radix bupleuri, cassia twig, dried ginger, pepper, yerbadetajo herb, fructus psoraleae, herba epimedii and polygonum multiflorum are used as guiding drugs. The sophora flavescens, the cortex dictamni, the rhizoma smilacis glabrae, the fructus kochiae and the radix stemonae have the effects of clearing heat, drying dampness, killing parasites and relieving itching. Modern pharmacological studies show that the sophora flavescens extract has the effect of inhibiting the activity of II-type 5 alpha-reductase, balancing the secretion of grease, dredging and astringing pores, promoting the growth and repair of damaged blood vessels, recovering the activity of subcutaneous capillary cells, accelerating blood circulation, improving the activity of hair follicles and achieving the treatment purpose of promoting hair growth by local administration. Cortex Dictamni Radicis has effects of clearing heat, eliminating dampness, dispelling pathogenic wind and removing toxic substance, and is described in materia Medica: the glabrous greenbrier rhizome has the effects of promoting diuresis and removing heat, entering collaterals and eliminating accumulation of damp-heat, so the combination of the glabrous greenbrier rhizome and the poria cocos can play the effect of crisp eyebrows. Experimental research results show that medicinal components contained in the cortex dictamni can not prevent cyclophosphamide from inducing alopecia of rats, but have an effect of resisting damaged hair follicles induced by the medicinal components and promoting hair growth of the rats, and the effect is related to inflammation resistance and immunosuppression. Broom cypress fruit and stemona root, radix stemonae, and radix stemonae: all people have nine worms in the abdomen … … and all the people have alopecia areata, which is caused by the worms, namely the insects are grown on the head, the white scabs are very itchy, and the hair is broken and does not fall, so the alopecia areata is called, and indicates that the alopecia is related to the invasion of worm pathogens, so that the traditional Chinese medicine needs to take a pesticide to prevent the alopecia. Original herbal statement: "remove accumulated heat in skin and wet itch except skin", Zhongkui of the republic of Pupuzi: "treating cough and killing parasites". Pharmacological research indicates that the fructus kochiae water-soaking agent (1: 3) has certain inhibiting effect on dermatophytes such as trichophyton schoenleinii, microsporum ozoensis and the like. The stemona water extract and the stemona alcohol extract can fully separate out the stemonine, the isocstemonine and the protostemonine contained in the stemona water extract and the stemona alcohol extract, and can play the roles of resisting bacteria, diminishing inflammation, killing parasites and relieving itching when being locally applied to hair follicles.

And Chinese angelica, suberect spatholobus stem, safflower, Szechuan lovage rhizome, tree peony bark, red paeony root and Chinese arborvitae twig have the effects of promoting qi and blood circulation, cooling blood, removing blood stasis and growing hair. The statement of "blood syndrome & blood stasis": "stagnant blood in the upper energizer or hair falling without growing. "doctor lin correction" (a statement: blood stasis outside the skin and inside the flesh, blood vessels are blocked, and new blood cannot nourish hair, so the hair falls. "Confucian relatives": the early white hair and early falling in the young, the blood heat too much can be seen, the blood deficiency, the blood stasis and the blood heat are all closely related to the hair growth, so the regulation of blood circulation is particularly important in the process of preventing and treating alopecia. The Chinese angelica is used for nourishing blood, promoting blood circulation and removing blood stasis; caulis Spatholobi has effects of replenishing blood, promoting blood circulation, and dredging collaterals; safflower promotes blood circulation, clears the channels and eliminates blood stasis; the combination of moutan bark and red peony root has the effects of clearing heat, cooling blood and removing blood stasis, and the compatibility of the ligusticum wallichii with qi-tonifying medicine in blood has the effects of promoting qi circulation and relieving depression, so that the medicine is good for treating upper diseases. The arborvitae tops cool blood and moisten dryness, and the compendium of materia medica discusses that the pine leaves (i.e. arborvitae tops) are "wind-damp sores, hair growing, five internal organs calming, middle energizer eliminating, life prolonging and beard and hair growing", and are matched with "Ying ying Sheng Yao" Chinese angelica, which can activate blood and promote blood generation and can also achieve the effect of hair regeneration. Research shows that the angelica sinensis can accelerate local metabolism, expand capillaries, improve cell oxygenation capacity, provide nutrition for hair follicles, and meanwhile, the angelica sinensis contains estrogen-like medicine components, can resist androgen, regulate and control immunologic functions, and improve local internal environment activity of the hair follicles, so that alopecia is slowed down. The volatile oil component (cedrol) contained in folium Platycladi can improve blood microcirculation of scalp, enhance cell nutrient, stimulate hair follicle growth, and promote hair growth. The paeonol can make effective components fully enter blood by enhancing skin capillary permeability, and has antiinflammatory and antibacterial effects. The anti-inflammatory chemical component of red peony root is total paeony glycoside, and the anticoagulant and antithrombotic action mechanism of the total paeony glycoside is that the excessive desensitization of G protein coupled receptor signal transduction is improved and the level of inflammatory factors is reduced by inhibiting the up-regulation of proinflammatory mediators such as tumor necrosis factor-alpha (TNF-alpha), IL-1 beta, iNOS, cyclooxygenase-2 (COX-2) and 5-lipoxygenase (5-LOX). In vitro human platelet tests show that the moutan bark aqueous extract and paeonol can inhibit thromboxane A2 generated by platelet arachidonic acid, inhibit platelet aggregation, regulate and control hemodynamic circulation, maintain local blood circulation and normal production supply, and further protect the activity of damaged hair follicles. The ethanol extract of rhizoma Ligustici Chuanxiong has effects of regulating platelet aggregation rate, stimulating capillary blood vessel sensitivity, regulating blood circulation of skin hair follicle, promoting blood circulation, removing blood stasis, and promoting hair growth.

The alopecia is localized on the head, like Bian, which is a mountain, so it can be seen only by wind and is easy to be attacked by wind; wind can be produced by damp-heat, blood-heat and blood deficiency, wind is yang pathogen, and the hair loss is just like wind-blown leaf fall, so wind-dispelling herbs such as Zi Cao, Bai Zhi Zi, Bo He, Fang Feng and Qiang Huo are added. It is intended to: the wind-herbs can move upwards to make the drug effect directly reach the focus; also, because alopecia is usually due to blood heat or yin deficiency with wind generation, wind-dispelling herbs have the action of dispelling wind, relieving itching and regulating and treating pruritus. In addition, wind-herbs can be treated by meridian theory, and different meridian-inducing herbs are supposed to be passed according to the different meridians of the disease, for example, Dahurian angelica root enters yangming on forehead; fructus Viticis entering jueyin at the head of the patient; notopterygium root enters the sun at the back head of the patient; fang Feng and chai Hu enter shao yang on the head side. Modern researches indicate that the mint has the effects of resisting inflammation, easing pain, resisting fungi, resisting viruses and the like, and the active ingredients of the mint and menthol promote the absorption of the medicine by changing the structure of the horny layer of the skin, so that the mint is the best medium carrier of the external medicine penetrant.

For alopecia, there is a bad diet habit of eating fat, sweet and thick flavor in longitudinal direction and being not contraindicated in cold or raw state, which causes spleen damage, dysfunction of transportation and transformation, endogenous phlegm, ascending along the channels, damp stagnation and hair root, hair follicle erosion, hair malnutrition, and hair loss. Phlegm-turbidity obstructing the body for a long time, transforming into heat or generating stasis, obstructing the circulation of qi and blood, so that old hair is not fixed and new hair is not generated. Pinellia ternate, rhizoma acori graminei and rhizoma atractylodis have the effects of drying dampness and harmonizing stomach, leveling cold and heat, relieving resuscitation, normalizing the spleen and stomach, internalizing damp turbidity, clearing stagnant heat and nourishing hair. Because the head is soaked by water, the treatment method can be used for getting the head out of the disease, and the hair is loosened because the hair is not soaked by water and the hair is loosened, thus the plantain and the alisma orientale which have thin smell are used for clearing heat and excreting dampness, promoting diuresis to descend and guiding turbidity to descend, and the treatment method also conforms to the Chinese medical diagnosis and treatment concept of 'treating the head by the principle of lying behind the head due to the fact that the head is soaked by water firstly'.

The hair follicle is one of the skin components, and the growth and metabolism of the hair follicle depend on the supply of qi, blood and body fluid, so that the hair follicle maintains normal physiological functions. The shaoyang meridian plays a pivotal role in transporting the interior and exterior in the circulation of the meridian. The shaoyang pivot functions normally, and qi-blood nutrient-defense transportation is normal, so that the skin hair follicle muscles are moist, otherwise, shaoyang pivot is unfavorable, the metabolism of the hair follicles is abnormal, and the hairs are not fixed and then are lost. Therefore, the formula takes the decoction of bupleurum, cassia twig and dried ginger, combines the three flavors of bupleurum, cassia twig and dried ginger and pepper, clears away stagnated heat, dredges liver and gallbladder, harmonizes yin and yang, kills parasites and relieves itching. Gu Shi Cheng in the great Specification of ulcer medicine: the four-two pricklyash peel is brewed with white spirit for seven days, and is used for moistening bald parts in the morning and evening and growing. The theory of 'external disease internal treatment' of traditional Chinese medicine circulation treatment is exerted. Radix bupleuri dredges qi movement and relieves shaoyang disease; ramulus Cinnamomi and Glycyrrhrizae radix have the effects of pungent and sweet taste and yang-invigorating, and regulating body fluid; the combination of gan Jiang and gan Cao can transform the pathogenic factors of taiyin into shao Yang, and the three herbs play the roles of cold and heat in regulating and clearing the upper-temperature.

The excess of blood, withered or deficient blood. Sudden alopecia, itching scalp, hair and eyebrow falling, and the symptoms of blood heat, wind generation and wind wood shaking are also included, so the root of alopecia is treated mainly by reinforcing kidney, nourishing kidney essence and nourishing source, and the hair root is not broken firmly, so the treatment method uses nourishing liver and kidney and filling essence and blood as the main method, so eclipta is used for tonifying kidney yin, psoralea is used for tonifying kidney yang, epimedium is used for filling essence and blood, and polygonum multiflorum is used for fixing beard and hair. The flavonoids contained in Ecliptae herba can expand blood vessel elasticity, inhibit platelet aggregation, regulate and control thrombin activity, and inhibit OH and O2 ^- Free radicals have strong scavenging ability, reduce lipid peroxide, and delay hair loss in the aspects of regulating immunity, endocrine and the like. Psoralen can improve blood circulation, resist bacteria, remove fat, increase estradiol and follicle-stimulating hormone cold dew, and realize the function of anti-male and anti-drop. The polygonum multiflorum is beneficial to hair follicle generation, and the prepared polygonum multiflorum has the effects of tonifying liver and kidney, benefiting essence and blood and promoting hair growth. Meanwhile, the hair growth promoter can also promote the hair growth by regulating the contents of a fiber-forming growth factor, beta-catenin and the like, thereby achieving the purpose of hair growth. Meanwhile, the four flavors are all black in color, and are faithful to the theory of Su Wen & Baoming holomorphism, namely that all things are familiar and precious, people grow from the nature of the heaven and earth, and the four seasons, people are coherent with the nature of the heaven and earth and correspond to the days and the months.

The external traditional Chinese medicine composition for preventing alopecia has various medicinal ingredients and comprehensive effects, combines the four flavors and five flavors of the medicinal ingredients, strictly conforms to the pathogenesis characteristics of alopecia, covers the disease characteristics of the disease in each stage of occurrence and development, combines the traditional Chinese medicine theory and the modern pharmacological experimental study, is beneficial to enriching the technical means for clinically treating alopecia, and brings good news to patients. Meanwhile, the use of the medicinal ingredients reflects the theory of meridian-viscera correlation in traditional Chinese medicine. The compatibility and application of the traditional Chinese medicine and the traditional Chinese medicine are combined with the disease position related to viscera and the focus occurrence position, and the traditional Chinese medicine are in accordance with the theory of Chinese medicine and western medicine, so that the total quantity of the traditional Chinese medicine and the traditional Chinese medicine is indispensable, medicines with similar efficacies are not required to be applied too much, and the problems of too many traditional Chinese medicines, too complicated efficacies and too violent side effects are avoided. Secondly, on the basis of the determination of the dosage of each medicine, the specific application range of the dosage of the medicine is determined according to the general conditions of the patients such as physique, shape, height, weight and the like, the medicine is applied according to the conditions of people and is personalized and flexible, the medicine effect optimization is realized as far as possible, the aim of clinical treatment is realized, the medicine is not required to be used excessively, and the influence of the side effect generated by the medicine or other effects on the whole curative effect of the whole prescription is avoided.

Compared with the prior art, the method has the beneficial technical effects.

Compared with the existing external preparation for preventing and treating alopecia in related traditional Chinese medicines, the formula provided by the invention has the advantages that the treatment principle closely conforms to the characteristics of etiology, pathogenesis and disease property, the differentiation of symptoms and thinking fully combines the differentiation of internal organs, the differentiation of symptoms and collaterals, the theory of the invention is embodied by the concept of 'holistic concept', 'both manifestation and root cause' and 'pathogenic factor and body resistance' of the traditional Chinese medicine prevention and treatment measures, and the invention is beneficial exploration and discovery of traditional Chinese medicine circulation treatment. The whole formula is based on the theory of holistic concept and syndrome differentiation and treatment in traditional Chinese medicine, and the whole formula is based on the pathogenesis of diseases, comprehensively covers the series of syndrome types derived in the process of alopecia occurrence and development, and is practical application of the theory system of 'holistic concept' and 'syndrome differentiation and treatment' in traditional Chinese medicine.

A topical Chinese medicinal composition for preventing alopecia is prepared by soaking in ethanol, making into tincture, and directly applying on head to effectively and directly act on head, slow disease process, resist bacteria, relieve inflammation, improve hair follicle microcirculation, reduce scalp oil secretion, improve scalp, reduce pruritus, and promote hair growth. And the tincture is more convenient to prepare than ointment, oil agent and the like, is not easy to pollute clothes, and is easy to be received by the public. The research and development of an external traditional Chinese medicine composition for preventing alopecia are carried out without departing from the diagnosis and treatment essences of the theory (pathological medicine theory), the method (treatment method), the formula (meridian formula + hour formula), the medicine (dialectical medicine) and the operation (external preparation) in the traditional Chinese medicine.

The tincture prepared by the invention has the effects of removing heat and drying dampness, nourishing liver and kidney, promoting blood circulation to remove blood stasis, fixing hair and preventing alopecia, is simple in preparation method and obvious in effect, belongs to a pure traditional Chinese medicine external preparation, does not damage liver and kidney functions, and is good in safety evaluation.

Detailed Description

Example 1.

1. The specific dosage of the formula and the preparation method.

The specific dosage of the formula is as follows: 15g of radix sophorae flavescentis, 15g of cortex dictamni, 15g of fructus kochiae, 15g of cacumen biotae, 15g of folium mori, 20g of rhizoma smilacis glabrae, 15g of radix stemonae, 10g of pinellia ternate, 15g of rhizoma acori graminei, 15g of rhizoma atractylodis, 15g of ligusticum wallichii, 15g of angelica sinensis, 15g of caulis spatholobi, 10g of safflower, 15g of cortex moutan radicis, 15g of radix paeoniae rubra, 10g of lithospermum, 15g of radix saposhnikoviae, 15g of notopterygium root, 15g of fructus viticis, 15g of radix angelicae, 15g of plantain herb, 15g of rhizoma alismatis, 15g of herba ecliptae, 15g of polygonum multiflorum, 15g of radix bupleuri, 10g of cassia twig, 15g of rhizoma zingiberis, 10g of pepper, 15g of fructus psoraleae, 15g of herba epimedii, 15g of liquorice and 12g of mint.

The preparation method comprises the following steps: soaking the above Chinese medicinal decoction pieces in 300ml of 75% ethanol for two weeks, discarding residues, pouring out supernatant, and wiping part for 2 times/day.

Example 2.

In the embodiment, the external traditional Chinese medicine for treating alopecia is distinguished as kidney essence deficiency and phlegm-blood stasis syndrome, and comprises the following components in parts by weight: 10g of radix sophorae flavescentis, 10g of cortex dictamni, 10g of fructus kochiae, 15g of cacumen biotae, 15g of folium mori, 15g of rhizoma smilacis glabrae, 10g of radix stemonae, 10g of pinellia ternate, 15g of rhizoma acori graminei, 10g of rhizoma atractylodis, 10g of ligusticum wallichii, 10g of angelica sinensis, 10g of caulis spatholobi, 10g of safflower, 10g of cortex moutan radicis, 10g of radix paeoniae rubra, 10g of lithospermum, 10g of radix sileris, 10g of notopterygium root, 10g of fructus viticis, 10g of radix angelicae, 10g of plantain herb, 10g of rhizoma alismatis, 10g of herba ecliptae, 10g of polygonum multiflorum, 10g of radix bupleuri, 10g of cassia twig, 10g of rhizoma zingiberis, 5g of pepper, 10g of fructus psoraleae, 10g of herba epimedii, 10g of liquorice and 10g of mint. Soaking the above decoction pieces in 300ml75% ethanol for two weeks, discarding the residue, pouring out the supernatant, and wiping the part for 2 times per day.

Example 3.

In the embodiment, the external traditional Chinese medicine for treating alopecia is identified as blood heat and wind dryness syndrome, and comprises the following components in parts by weight: 20g of radix sophorae flavescentis, 30g of cortex dictamni, 20g of fructus kochiae, 30g of cacumen biotae, 30g of folium mori, 20g of rhizoma smilacis glabrae, 15g of radix stemonae, 15g of pinellia ternate, 20g of rhizoma acori graminei, 30g of rhizoma atractylodis, 25g of ligusticum wallichii, 25g of angelica sinensis, 25g of caulis spatholobi, 25g of safflower, 20g of cortex moutan radicis, 20g of radix paeoniae rubra, 20g of lithospermum, 20g of radix saposhnikoviae, 30g of notopterygium root, 30g of fructus viticis, 25g of radix angelicae, 25g of plantain herb, 30g of rhizoma alismatis, 30g of herba ecliptae, 30g of polygonum multiflorum, 25g of radix bupleuri, 20g of cassia twig, 25g of rhizoma zingiberis, 15g of pepper, 30g of fructus psoraleae, 30g of herba epimedii, 20g of liquorice and 25g of mint, soaking the traditional Chinese medicine decoction pieces in 300ml of 75% alcohol for two weeks, discarding dregs, pouring out supernatant liquid medicine, and wiping the local part for 2 times per day.

Example 4.

Research on pharmacology of traditional Chinese medicines.

The prescription medication of the traditional Chinese medicine is based on treatment based on syndrome differentiation, and the dosage control strategy is based on the correlation between the dosage and the curative effect, namely the dosage is secret in the Chinese medicine beyond the transmission. The dosage of the prescription is an important step after the differentiation of symptoms and signs and the sending of prescriptions, and is an important influence factor for realizing the curative effect. Dosage is the standard of expected efficacy, which is the standard for testing success or failure of treatment. The traditional Chinese medicine prescription has lower dosage threshold and wider treatment window, which is closely related to the complexity of clinical symptoms, individual difference of patients and the responsiveness of patients to the prescription. The content of the influence of the medicine flavor and the medicine amount on the clinical efficacy of preventing and treating alopecia is summarized as follows:

pharmacological experimental study I.

1. Materials and methods.

1.1 Experimental drugs.

The prescription comprises the following components in parts by weight: an external traditional Chinese medicine for treating alopecia comprises the following components in parts by weight: 10-20 parts of radix sophorae flavescentis, 10-30 parts of cortex dictamni, 10-20 parts of fructus kochiae, 15-30 parts of cacumen biotae, 15-30 parts of folium mori, 15-20 parts of rhizoma smilacis glabrae, 10-15 parts of radix stemonae, 10-15 parts of pinellia ternate, 15-20 parts of rhizoma acori graminei, 10-30 parts of rhizoma atractylodis, 10-25 parts of ligusticum wallichii, 10-25 parts of angelica sinensis, 10-25 parts of caulis spatholobi, 10-25 parts of safflower carthamus, 10-20 parts of moutan bark, 10-20 parts of radix paeoniae rubra, 10-20 parts of lithospermum, 10-20 parts of radix saposhnikoviae, 10-30 parts of notopterygium root, 10-30 parts of fructus viticis, 10-25 parts of radix angelicae, 10-25 parts of plantain, 10-30 parts of rhizoma alismatis, 10-30 parts of eclipta, 10-30 parts of polygonum multiflorum, 10-25 parts of radix bupleuri, 10-20 parts of cassia twig, 10-25 parts of rhizoma zingiberis, 5-15 parts of pepper, 10-30 parts of fructus psoraleae, 10-30 parts of herba epimedii, 10-20 parts of liquorice and 10-25 parts of mint.

The medicine is divided into 2 groups according to the medicine flavor and the dosage.

Group A comprises the following components: 15g of radix sophorae flavescentis, 15g of cortex dictamni, 15g of fructus kochiae, 20g of cacumen biotae, 15g of folium mori, 20g of rhizoma smilacis glabrae, 15g of radix stemonae, 15g of pinellia ternate, 15g of rhizoma acori graminei, 15g of rhizoma atractylodis, 15g of ligusticum wallichii, 15g of angelica sinensis, 15g of caulis spatholobi, 10g of safflower, 10g of cortex moutan, 15g of radix paeoniae rubra, 10g of lithospermum, 15g of radix saposhnikoviae, 15g of notopterygium root, 15g of fructus viticis, 15g of radix angelicae, 15g of plantain herb, 15g of rhizoma alismatis, 15g of herba ecliptae, 20g of polygonum multiflorum, 15g of radix bupleuri, 10g of cassia twig, 15g of rhizoma zingiberis, 10g of pepper, 15g of fructus psoraleae, 15g of herba epimedii, 15g of liquorice and 12g of mint.

Group B comprises the following components: 5g of radix sophorae flavescentis, 5g of cortex dictamni, 5g of fructus kochiae, 10g of cacumen biotae, 10g of folium mori, 10g of rhizoma smilacis glabrae, 5g of radix stemonae, 5g of pinellia ternate, 10g of rhizoma acori graminei, 5g of rhizoma atractylodis, 5g of ligusticum wallichii, 5g of angelica sinensis, 5g of caulis spatholobi, 10g of safflower, 5g of cortex moutan radicis, 5g of radix paeoniae rubra, 10g of lithospermum, 5g of radix sileris, 5g of notopterygium root, 5g of fructus viticis, 5g of radix angelicae, 5g of plantain herb, 5g of rhizoma alismatis, 5g of herba ecliptae, 5g of polygonum multiflorum, 5g of radix bupleuri, 5g of cassia twig, 5g of rhizoma zingiberis, 5g of pepper, 5g of fructus psoraleae, 5g of herba epimedii, 5g of liquorice and 5g of mint.

1.2 animals were grouped.

The healthy male and female half white mice are 50 mice, 22-30 days old, 22-28 g in weight, and closed group system, and are provided by Liaoning traditional Chinese medicine university animal experiment center. The breeding is adapted to 1 week under experimental conditions, the temperature of the breeding environment is kept at 26 ℃, the indoor humidity is controlled at 70%, and the indoor free ventilation is kept. The area of fur on the back 1.5cm x 2cm was selected for each mouse before the experiment and the area of hair loss was determined by staining it yellow with 3% solution of picric acid. Animals in each group except the normal control group were injected with 1 mg/kg. d dose of testosterone propionate subcutaneously at the back of the neck 1 time a day for 60 days continuously to create a lipid loss model. After the adaptive feeding is finished, the group is randomly divided into a group A and a group B, and each group contains 25 animals.

1.3 preparation and dosage of the medicine.

Soaking the above decoction pieces in 300ml of 75% ethanol for two weeks, discarding residues, pouring out the supernatant, and topically applying for 2 times per day. The administration dosage refers to the content of pharmacopoeia: the clinical dose of human (70 kg) was 0.035g/kg, and the dose of mouse was calculated from the ratio of the body surface area of human to that of mouse.

1.4 Observation index.

The skin change on the back of the mouse and the growth of the hair of the mouse are observed every day, and the hair length of the mouse in the experimental area is measured by a vernier caliper. After 45d, from 3cm ² The area was then harvested and 10 needles were sectioned and the change in the hair follicles was observed microscopically. And finally, fixing skin tissues in an experimental area by 10% formaldehyde, continuously taking 3 tissues along the longitudinal section of the hair follicle, wherein each tissue is 1.5cm long, and performing conventional tissue dehydration, paraffin embedding, HE (high-intensity electrophoresis) staining, optical microscopy and observation on the skin tissues of the mouse. The diameter (mum) of a dermal superficial blood vessel is randomly measured, and the diameters of 5 crosscut capillaries are calculated on average; counting the number of blood vessels (number) in the superficial dermis by 200 times of the size of visual field, counting 5 visual fields, and calculating the average number; number of new hair follicles (number) in the superficial dermis was counted in 100-fold visual field size, 5 visual fields were counted, and the average number was calculated.

1.5 statistical treatment.

Statistical analysis was performed on the data of this study using SPSS22.0 software. The measured data are expressed in (x +/-s) by adopting a t test; the count data are expressed in n (%) as x ² And (6) checking. P < 0.05 is statistically different.

2. And (6) obtaining the result.

2.1 Hair growth in two groups of mice.

As can be seen from the table, the hair growth length of the mice in group A is significantly better than that of the mice in group B at the same period, and the difference suggests that the statistical significance is achieved (P < 0.05).

Table 1 two groups of mice were compared in hair growth length (mm) (n = 25).

。

Note: suggesting that the comparison between the same period groups shows that P < 0.05 has statistical difference.

2.2 histological condition of the dorsal skin of two groups of mice.

As can be seen from the table, the group A is significantly superior to the group B in terms of the histological change of the back skin, such as expansion of the dermal superficial capillaries of the mice, enhancement of the local blood volume, improvement of the local microcirculation, enhancement of the hair follicle nutrition, promotion of the hair growth, and the like, and the difference has statistical significance (P is less than 0.05).

Table 2 two groups of mice were compared for dorsal skin histology (n = 25).

。

From the above research results, the prescriptions with the same medicinal taste, different dosages and different curative effects are commonly used clinically. Regarding the traditional Chinese medicine pharmacology stone test and the traditional Chinese medicine clinical practice, the dose-effect relationship is found to have important effects, and can be summarized into five aspects, namely that the correct medicinal dose determines the success or failure of curative effect, the medicament dose proportion in the prescription directly influences the curative effect, the change of the dose proportion among the medicaments in the prescription directly influences the treatment direction of the prescription, and the biological activity of the medicaments directly influences the dose of the medicaments and the bidirectional effect of the Chinese medicaments guides the dose of the medicaments. Therefore, in the research, the dosage control of the definite medicines strictly complies with the dosage regulation of the Chinese medicine pharmacopoeia, and the dosage of each medicine is formulated according to the related pharmacological test conclusion of the optimal dosage of single or compound medicines for preventing and treating alopecia, so that the optimal curative effect is obtained. For example, 5-20 parts of radix sophorae flavescentis can reduce the levels of ICAM-1 and ELAM-1, inhibit migration and chemotaxis of inflammatory cells, relieve the activated proinflammatory leukocytes from attacking hair follicles, inhibit infiltration of T lymphocytes to the hair follicles, relieve inflammatory and immune injuries caused to hair follicle cells and treat alopecia; 10-25 parts of angelica sinensis improves local microcirculation and nutrition metabolism of hair follicles, reduces apoptosis in hair follicles in a catagen phase, inhibits the hair follicles from entering the catagen phase, and promotes hair growth.

Example 5.

And II, pharmacological experimental study.

1. Materials and methods.

1.1 Experimental drugs.

The prescription comprises the following components in parts by weight: the externally applied traditional Chinese medicine for treating alopecia comprises the following components in parts by weight: 10-20 parts of radix sophorae flavescentis, 10-30 parts of cortex dictamni, 10-20 parts of fructus kochiae, 15-30 parts of cacumen biotae, 15-30 parts of folium mori, 15-20 parts of rhizoma smilacis glabrae, 10-15 parts of radix stemonae, 10-15 parts of pinellia ternate, 15-20 parts of rhizoma acori graminei, 10-30 parts of rhizoma atractylodis, 10-25 parts of ligusticum wallichii, 10-25 parts of angelica sinensis, 10-25 parts of caulis spatholobi, 10-25 parts of safflower carthamus, 10-20 parts of moutan bark, 10-20 parts of radix paeoniae rubra, 10-20 parts of lithospermum, 10-20 parts of radix saposhnikoviae, 10-30 parts of notopterygium root, 10-30 parts of fructus viticis, 10-25 parts of radix angelicae, 10-25 parts of plantain, 10-30 parts of rhizoma alismatis, 10-30 parts of eclipta, 10-30 parts of polygonum multiflorum, 10-25 parts of radix bupleuri, 10-20 parts of cassia twig, 10-25 parts of rhizoma zingiberis, 5-15 parts of pepper, 10-30 parts of fructus psoraleae, 10-30 parts of herba epimedii, 10-20 parts of liquorice and 10-25 parts of mint.

Group C comprises the following components: 10g of radix sophorae flavescentis, 10g of cortex dictamni, 10g of fructus kochiae, 15g of cacumen biotae, 15g of folium mori, 20g of rhizoma smilacis glabrae, 15g of radix stemonae, 15g of pinellia ternate, 15g of rhizoma acori graminei, 10g of rhizoma atractylodis, 10g of ligusticum wallichii, 10g of angelica sinensis, 10g of caulis spatholobi, 10g of safflower, 10g of cortex moutan radicis, 10g of radix paeoniae rubra, 10g of lithospermum, 10g of radix sileris, 10g of notopterygium root, 10g of fructus viticis, 10g of radix angelicae, 10g of plantain herb, 10g of rhizoma alismatis, 10g of herba ecliptae, 10g of polygonum multiflorum, 10g of radix bupleuri, 10g of cassia twig, 10g of rhizoma zingiberis, 5g of pepper, 10g of fructus psoraleae, 10g of herba epimedii, 10g of liquorice and 10g of mint.

Group D of the formula: 10g of fructus kochiae, 15g of cacumen biotae, 15g of folium mori, 20g of rhizoma smilacis glabrae, 15g of radix stemonae, 15g of pinellia ternate, 15g of rhizoma acori graminei, 10g of rhizoma atractylodis, 10g of angelica sinensis, 10g of caulis spatholobi, 10g of cortex moutan, 10g of radix paeoniae rubra, 10g of radix saposhnikoviae, 10g of notopterygium root, 10g of radix angelicae, 10g of rhizoma alismatis, 10g of herba ecliptae, 10g of polygonum multiflorum, 10g of radix bupleuri, 10g of cassia twig, 5g of pepper and 10g of herba epimedii.

1.2 animals were grouped.

The healthy male and female half-white mice are 50 mice, 23-30 days old, 21-28 g in weight, and are closed group system provided by Liaoning Chinese medicine university animal experiment center. The breeding is adapted to 1 week under experimental conditions, the temperature of the breeding environment is kept at 26 ℃, the indoor humidity is controlled at 70%, and the indoor free ventilation is kept. Before the experiment, fur was collected on the back of each mouse in an area of 1.5cm × 2cm, and the area of the fur was stained yellow with a 3% picric acid solution to determine the hair removal area. Except the normal control group, the animals in each group were injected with testosterone propionate in a dose of 1 mg/kg. d subcutaneously 1 time a day for 60 days continuously to cause fat loss model. After the adaptive feeding is finished, the group is randomly divided into a group C and a group D, and each group contains 25 animals.

1.3 preparation and dosage of the medicine.

Soaking the above decoction pieces in 300ml of 75% ethanol for two weeks, discarding residues, pouring out the supernatant, and topically applying for 2 times per day. The administration dosage refers to contents of pharmacopoeia: the clinical dose of human (70 kg) was 0.035g/kg, and the dose of mouse was calculated from the ratio of the body surface area of human to that of mouse.

1.4 Observation index.

The skin change on the back of the mouse and the growth of the hair of the mouse are observed every day, and the hair length of the mouse in the experimental area is measured by a vernier caliper. After 45d, from 3cm ² The area was then harvested and 10 needles were sectioned and the change in the hair follicles was observed microscopically. And finally, fixing skin tissues in an experimental area by 10% formaldehyde, continuously taking 3 tissues along the longitudinal section of the hair follicle, wherein each tissue is 1.5cm in length, and performing conventional tissue dehydration, paraffin embedding, HE (high-intensity polyethylene) staining, optical microscopy and observation on the skin tissues of the mice. The tube diameters (mum) of dermal superficial blood vessels are randomly measured, and the average number of the tube diameters of 5 transected capillaries is calculated; counting the number of blood vessels (number) in the superficial dermis by 200 times of the size of visual field, counting 5 visual fields, and calculating the average number; number of new hair follicles (number) in the superficial dermis was counted in 100-fold visual field size, 5 visual fields were counted, and the average number was calculated.

1.5 statistical treatment.

3. And (4) obtaining the result.

3.1 Hair growth status in two groups of mice.

As can be seen from the table, the hair growth length of mice in group C was significantly better than that of mice in group D at the same period, and the difference suggested statistical significance (P < 0.05).

Table 3 two groups of mice hair growth length (mm) comparison (n = 25)

。

Note: a statistical difference was noted between cohorts with P < 0.05.

2.2 histological conditions of the dorsal skin of two groups of mice

As can be seen from the table, the group C is significantly better than the group D mice in the same period in terms of the changes of the back skin histology, such as expanding the dermal superficial capillaries of the mice, enhancing the local blood volume, improving the local microcirculation, strengthening the hair follicle nutrition and promoting the hair growth, and the differences have statistical significance (P is less than 0.05).

Table 4 two groups of mice were compared for dorsal skin histology (n = 25).

。

Note: a statistical difference was noted between cohorts with P < 0.05.

From the above results, it is known that the dosage of the drugs is the same, but the selection of the drug flavor is extremely important for the clinical efficacy. The kidney's bones are also involved in hair growth; kidneys store essence, they grow marrow, which fills in bones and then converges with brain, and they are the exogenous condition of kidney essence, and abundant essence and blood, which make them dense and lustrous. The research of data mining indicates that the common medicines comprise Chinese angelica, tuber fleeceflower root, prepared rhizome of rehmannia, Szechuan lovage rhizome, Chinese arborvitae twig, safflower, Chinese angelica and malaytea scurfpea fruit in the frequency of medication; in the classification of drugs, the blood-activating and stasis-resolving herbs are the first of the non-deficiency-tonifying herbs; the medicinal materials are selected to be pungent, sweet and bitter in flavor; in the selection of the properties, the topical herbs are mainly warm herbs, cold and cool herbs and mild herbs; the herbs enter the meridians, most of them enter the five zang organs, most of them enter the liver meridian, and most of them enter the stomach meridian. Therefore, the invention finally determines the medicinal ingredients of the traditional Chinese medicine composition to be radix sophorae flavescentis, cortex dictamni, fructus kochiae, cacumen biotae, ligusticum wallichii, angelica sinensis, caulis spatholobi, safflower, radix sileris, notopterygium root, herba ecliptae, polygonum multiflorum, radix bupleuri, fructus psoraleae, herba epimedii and the like, and the traditional syndrome types appearing in the processes of generation, development, pathogenesis and pathological development of alopecia are comprehensively covered.

And (5) clinical trials.

60 patients with confirmed diagnosis of alopecia are selected, and all patients meet the diagnosis standard in Chinese clinical dermatology: sudden onset, round or oval spot alopecia on the head with clear margins: the skin of the hair loss area is normal without obvious subjective symptoms, the hair loss area has no obvious atrophy and scar, and the hair follicle opening is clear and visible: the local part can have mild itching feeling and no general symptoms. Androgen-induced alopecia, refer to the diagnostic standard in Chinese clinical dermatology: progressive alopecia, starting from the two sides of the forehead, gradually reduces the hair density, and the hair is thin, thin and spread to the top of the head; in areas of hair loss, fine vellus hairs, smooth skin, greasy scalp, or itching are visible. The traditional Chinese medicine diagnosis refers to the diagnosis standard of traditional Chinese medicine skin pathology which is a national high-level teaching material of traditional Chinese medicine academy: the patient has the alopecia of flaky shape, the scalp is scorched and hot, the itching is caused, the insect and ant bite feeling is caused, the dysphoria is restless, the vexation is testy, the fur is thin or yellow and greasy, the tongue is red, and the pulse is wiry. And extracting patients into an experimental group and a control group by adopting a random digital method, and observing 24 male cases and 6 female cases in the groups; age 18-43 (35 ± 2.9) years; the course of the disease is 2 weeks to 3 years; 15 cases of alopecia areata and 15 cases of seborrheic alopecia. Control group 25 men and 5 women; age 18-45 (37 + -3.4) years; the course of disease is 1 month to 5 years; 16 cases of alopecia areata and 14 cases of seborrheic alopecia. The difference between the sex, age, disease course and hair loss type of the two groups of patients is not statistically significant (P > 0.05).

The observation group applied an external traditional Chinese medicine composition for preventing alopecia to wipe scalp, after the local part is fully moistened, the patient is ordered to massage scalp, and the absorption of the hair to the medicine is increased for 2 times per day. The control group adopts 2% minoxidil tincture (manufacturer: Zhejiang Wan Cheng drug industry Co., Ltd.; production lot number national drug quasi-character H20010714) for local external use: 1ml of minoxidil (50 mg, about 7 sprays) is applied to the affected part of the head, starting from the center of the affected part, and is rubbed by hands for 3-5 minutes for 2 times per day. The curative effect is judged for 6 months of treatment in both groups.

(1) The standard of curative effect refers to the content of the clinical research guiding principle of new traditional Chinese medicine, and the curative effect is divided into 4 grades of recovery, obvious effect, effective and ineffective. And (3) healing: the hair can stop falling and the alopecia can grow out completely, and the distribution density, the thickness and the color of the hair can be the same as those of a hair-care area, and the sebum secretion can be recovered to be normal. The effect is shown: the hair can stop falling, the hair loss can be regenerated by more than 70 percent, and the sebum secretion of the hair-strengthening area is obviously reduced, wherein the density, the thickness and the color of the hair-strengthening area are close to those of the hair-strengthening area. The method has the following advantages: the hair is stopped from falling, the hair loss is regenerated by more than 30 percent, and vellus hairs and white hairs are grown. And (4) invalidation: the hair regeneration is less than 30% or baldness continues. Effective rate = (number of cure cases + number of effective cases)/total number of cases × 100%. (2) The standard of the traditional Chinese medicine symptom accumulation refers to the content of clinical guidelines of new traditional Chinese medicines, the pruritus degree, the greasiness degree, the alopecia condition, the new hair condition and the scale degree are scored according to the 7-point method principle, 3 points (serious exacerbation, exacerbation degree is more than or equal to 70 percent), -2 points (moderate exacerbation, exacerbation degree is more than 30 percent and less than 70 percent), -1 point (mild exacerbation, exacerbation degree is less than or equal to 30 percent), 0 point (no change), 1 point (slight improvement, improvement degree is less than or equal to 30 percent), 2 points (moderate improvement, improvement degree is more than 30 percent and less than 70 percent) and 3 points (obvious improvement, improvement degree is more than or equal to 70 percent). (3) Reference to dermatology is made to "clinical dermatology": changes in hair diameter, peritrichological depressions, scalp pigmentation, and scalp inflammatory response before and after treatment were recorded in counts for both groups of patients. (4) And (3) safety evaluation: (ii) a Adverse reactions, local pain, redness and swelling, itching, increased dandruff, tight scalp feel, increased hair loss and the like appeared on the patients were recorded.

As a result: (1) the clinical curative effect is as follows: 16 cases, 7 cases, 5 cases and 2 cases of effectiveness are cured in a treatment group, and the effective rate is 93.33%; the control group heals 7 cases, 9 cases with obvious effect, 5 cases with effect and 9 cases with no effect, the effective rate is 70.00 percent, which shows that the external traditional Chinese medicine composition for preventing alopecia can effectively improve clinical symptoms, slow down the disease process and improve the life quality.

(2) Traditional Chinese medicine syndrome integration: before treatment, the integration of the pruritus degree, the greasiness degree, the alopecia condition, the new hair condition and the scale degree of two groups of patients has no significant difference (P is more than 0.05); after treatment, the integration of the degree of itching, the degree of greasiness, the condition of alopecia, the condition of new hair and the degree of scaling of the patients in the treatment group is obviously smaller than that in the control group (P is less than 0.05). (3) Before treatment, the skin mirror signs (large difference of hair diameter, hair circumference depression, scalp pigmentation and scalp inflammatory reaction) of two groups of patients have no significant difference (P is more than 0.05); after treatment, the dermatoscopic signs (large hair diameter difference, hair periphery depression, scalp pigmentation and scalp inflammatory reaction) of the patients in the treatment group are improved obviously better than those in the control group (P is less than 0.05). (4) And (3) safety evaluation: local stimulation pain appears after 1 case of medication in the treatment group, and 1 case of slight red swelling appears; in the control group 1, 2 patients had local burning sensation of scalp, 2 patients had red swelling, and 1 patient had aggravated scalp itching; adverse events were mild in both groups and were relieved by withdrawal or reduction, with no statistical difference (P > 0.05).

Claims

1. An external traditional Chinese medicine composition for preventing alopecia is characterized by comprising the following components in parts by weight: 10-20 parts of radix sophorae flavescentis, 10-30 parts of cortex dictamni, 10-20 parts of fructus kochiae, 15-30 parts of cacumen biotae, 15-30 parts of folium mori, 15-20 parts of rhizoma smilacis glabrae, 10-15 parts of radix stemonae, 10-15 parts of pinellia ternate, 15-20 parts of rhizoma acori graminei, 10-30 parts of rhizoma atractylodis, 10-25 parts of ligusticum wallichii, 10-25 parts of angelica sinensis, 10-25 parts of caulis spatholobi, 10-25 parts of safflower carthamus, 10-20 parts of moutan bark, 10-20 parts of radix paeoniae rubra, 10-20 parts of lithospermum, 10-20 parts of radix saposhnikoviae, 10-30 parts of notopterygium root, 10-30 parts of fructus viticis, 10-25 parts of radix angelicae, 10-25 parts of plantain, 10-30 parts of rhizoma alismatis, 10-30 parts of eclipta, 10-30 parts of polygonum multiflorum, 10-25 parts of radix bupleuri, 10-20 parts of cassia twig, 10-25 parts of rhizoma zingiberis, 5-15 parts of pepper, 10-30 parts of fructus psoraleae, 10-30 parts of herba epimedii, 10-20 parts of liquorice and 10-25 parts of mint.

2. The external traditional Chinese medicine composition for preventing alopecia is characterized by preferably comprising the following components in parts by weight: 15g of radix sophorae flavescentis, 15g of cortex dictamni, 15g of fructus kochiae, 15g of cacumen biotae, 15g of folium mori, 20g of rhizoma smilacis glabrae, 15g of radix stemonae, 10g of pinellia ternate, 15g of rhizoma acori graminei, 15g of rhizoma atractylodis, 15g of ligusticum wallichii, 15g of angelica sinensis, 15g of caulis spatholobi, 10g of safflower, 15g of cortex moutan radicis, 15g of radix paeoniae rubra, 10g of lithospermum, 15g of radix saposhnikoviae, 15g of notopterygium root, 15g of fructus viticis, 15g of radix angelicae, 15g of plantain herb, 15g of rhizoma alismatis, 15g of herba ecliptae, 15g of polygonum multiflorum, 15g of radix bupleuri, 10g of cassia twig, 15g of rhizoma zingiberis, 10g of pepper, 15g of fructus psoraleae, 15g of herba epimedii, 15g of liquorice and 12g of mint.

3. A topical Chinese medicinal composition for preventing alopecia is prepared by soaking the above decoction pieces in 300ml75% ethanol for two weeks, discarding residues, and collecting supernatant.

4. The use of the Chinese medicinal composition according to claim 1 or claim 2 or the Chinese medicinal composition prepared by the preparation method according to claim 3 in the preparation of medicaments for treating heat-clearing and dampness-drying, liver and kidney nourishing, blood circulation promoting, blood stasis removing, hair strengthening and alopecia preventing.

5. The use of claim 4, wherein the pharmaceutical dosage form is a tincture.

6. The use according to claim 4, wherein the clinical dosage is: 0.035g of said drug corresponds to 1 kg of body weight of the human being, 2 times per day.