A pharmaceutical composition for promoting hair growth and preventing hair loss, its preparation method and application

Abstract

The present invention belongs to the technical field of hair growth promotion, and particularly relates to a pharmaceutical composition for hair growth promotion, its preparation method and application. Calculated by weight fraction, the raw materials of the pharmaceutical composition of the present invention include: 10-20 parts of polygonatum sibiricum, 10-20 parts of longan, 10-15 parts of wolfberry, 10-15 parts of mulberry, 5-10 parts of Chinese yam, 10-20 parts of red date, 8-12 parts of lily, 10-20 parts of black bean, 10-20 parts of black sesame, 5-10 parts of glossy privet fruit, 10-30 parts of semen alpinaekatsumadai, 10-20 parts of angelica sinensis, 2-15 parts of fingered citron, 5-15 parts of wild jujube seed and 5-20 parts of American ginseng. The composition of the present invention is made with a suitable raw material ratio, has a reasonable compatibility, and has the effects of tonifying the liver and kidney, strengthening the spleen and benefiting the lung, promoting hair growth and preventing hair loss. This product can activate hair follicles and strengthen the development of the scalp.

Description

Technical Field

[0001] The present invention belongs to the technical field of hair growth promotion and hair loss prevention, and particularly relates to a pharmaceutical composition for hair growth promotion and hair loss prevention, a preparation method thereof, and an application thereof. Background Art

[0002] Hair is produced by hair follicles. A hair follicle consists of an epithelial cell sheath originating from the epidermis and a hair bulb containing globular keratinocytes that are in a constant state of division during hair growth. Each hair follicle shows an independent growth cycle, namely three consecutive stages: anagen, catagen, and telogen. Hair loss is divided into two categories: normal hair loss and pathological hair loss. Normal hair loss refers to the shedding of hairs in the catagen or telogen stage; pathological hair loss refers to the abnormal or excessive shedding of hairs that are not in the catagen and telogen stages. Pathological hair loss often leads to phenomena such as baldness and alopecia areata, greatly affecting people's health and appearance.

[0003] For a long time, hair loss has troubled people's normal life, so the research and development of products for hair growth promotion, hair care, and hair nourishment have attracted much attention. At present, there are many drugs and hair growth liquids for preventing and treating hair loss, and the product effects vary; while supplementing hair nutrition through the oral route, such as taking food supplements or functional foods, to protect and maintain hair in a good state is still a relatively new hair care method.

[0004] Traditional Chinese medicine theory holds that: "The kidney stores essence, and the liver stores blood", "Essence and blood are mutually generated, and when essence and blood are abundant, the human body is strong", "The luster of the kidney is manifested in the hair, and hair is the surplus of blood". The withering, whitening, and shedding of hair are closely related to the essence and blood of the liver and kidney. Therefore, the treatment of hair loss should start from tonifying the kidney and nourishing blood. Make full use of traditional Chinese medicine to tonify qi and blood, promote blood circulation in the scalp, and enable the scalp, hair, and hair follicles to obtain sufficient nutrition.

[0005] Chinese Patent Application CN104814428A discloses a nutritional composition for treating hair loss and white hair. The nutritional composition contains the following raw materials in weight percentages: 25-35% of black beans, 15-30% of black sesame seeds, 15-25% of black mulberries, 10-20% of walnut kernels, and 10-20% of Chinese yams. Preparation: Weigh the raw materials according to the weight percentages; wash the black beans, black sesame seeds, and black mulberries, dry them, and set aside; add 15 mL / 100 g of 50° liquor to the washed black beans and stir-fry until cooked; add 1 mL / 10 g of vinegar to the walnut kernels and stir-fry until dry; peel and slice the fresh Chinese yams, and then dry them in the sun or air-dry; mix, crush, and sieve the raw materials after the above steps, and finally bag and seal for storage.

[0006] Chinese Patent Application for Invention CN103271273A discloses a health food for treating hair loss, which is made from the following raw materials in parts by weight: 30 - 60 parts of black beans, 80 - 100 parts of black rice, 20 - 30 parts of black sesame seeds, 5 - 10 parts of lilies, 5 - 10 parts of coix seeds, 5 - 15 parts of walnuts, 20 - 100 parts of rice, 5 - 10 parts of brown sugar, 10 - 15 parts of fleece-flower roots, 20 - 30 parts of Chinese yams, 5 - 10 parts of gordon euryale seeds, 5 - 10 parts of Chinese wolfberries, 5 - 10 parts of hawthorns, 2 - 5 parts of honeysuckle flowers, and 3 - 6 parts of red dates.

[0007] However, as a health food or drug for strengthening hair and promoting hair growth, it is likely to cause excessive hair growth in other parts of the body, low blood pressure, arrhythmia or rapid heartbeat, etc. The present invention selects traditional Chinese medicine varieties of "medicinal and edible homology", and through a large amount of research and exploration, a drug formula with the function of strengthening hair and promoting hair growth is obtained, providing a feasible diet therapy approach to solve the existing problems of current hair loss. Summary of the Invention

[0008] Aiming at the deficiencies of the prior art, based on traditional Chinese medicine theory and combining the application of products of "medicinal and edible homology" in the field of medicine, the present invention provides a drug composition for strengthening hair and promoting hair growth, which can reduce hair loss and promote hair growth as well.

[0009] To achieve the above-mentioned invention purpose, the present invention adopts the following technical solutions:

[0010] A drug composition for strengthening hair and promoting hair growth, calculated by weight fraction, the raw materials of the drug composition include: 10 - 20 parts of polygonatum sibiricum, 10 - 20 parts of longan, 10 - 15 parts of Chinese wolfberry, 10 - 15 parts of mulberry, 5 - 10 parts of Chinese yam, 10 - 20 parts of red date, 8 - 12 parts of lily, 10 - 20 parts of black bean, 10 - 20 parts of black sesame seed, 5 - 10 parts of glossy privet fruit, 10 - 30 parts of semen alpiniae oxyphyllae, 10 - 20 parts of angelica sinensis, 2 - 15 parts of fingered citron, 5 - 15 parts of wild jujube seed, and 5 - 20 parts of American ginseng.

[0011] Preferably, calculated by weight fraction, the raw materials of the drug composition include: 12 - 15 parts of polygonatum sibiricum, 12 - 15 parts of longan, 10 - 12 parts of Chinese wolfberry, 10 - 12 parts of mulberry, 6 - 8 parts of Chinese yam, 12 - 16 parts of red date, 10 - 12 parts of lily, 15 - 20 parts of black bean, 15 - 20 parts of black sesame seed, 5 - 8 parts of glossy privet fruit, 12 - 18 parts of semen alpiniae oxyphyllae, 12 - 18 parts of angelica sinensis, 3 - 10 parts of fingered citron, 8 - 12 parts of wild jujube seed, and 5 - 10 parts of American ginseng.

[0012] Polygonatum sibiricum has a sweet taste and a neutral nature. It can replenish qi and nourish yin, strengthen the spleen, moisten the lungs, and benefit the kidneys. It is used for weakness of the spleen and stomach, fatigue, lack of appetite with dry mouth, dry cough due to lung deficiency, insufficiency of essence and blood, and internal heat with thirst.

[0013] Longan, also known as longan pulp, is sweet in taste and warm in nature. It can replenish the heart and spleen, nourish blood and calm the mind. It is used for qi and blood deficiency, palpitations, forgetfulness, insomnia, and sallow complexion due to blood deficiency.

[0014] Glossy privet fruit is bitter and sweet in taste and cool in nature. It can nourish the liver and kidney, improve eyesight and blacken hair. It is used for yin deficiency of the liver and kidney, dizziness, tinnitus, soreness and weakness of the waist and knees, premature whitening of hair, dim vision, internal heat and thirst, and hectic fever.

[0015] Wolfberry, also known as Chinese wolfberry fruit. It is sweet in taste and neutral in nature. It belongs to the liver, kidney, and lung meridians. It can nourish yin and blood, nourish the liver and kidney, improve eyesight, moisten the lungs, and enhance immune function.

[0016] Mulberry fruit is sweet and sour in taste and cold in nature. It belongs to the heart, liver, and kidney meridians. It can tonify the liver and kidney, nourish blood, and is used for dizziness, tinnitus, premature whitening of hair, and hair loss. Traditional Chinese medicine believes that mulberry fruit has the effects of tonifying the liver and kidney, nourishing yin and blood, promoting fluid production and moistening the intestines, calming endogenous wind, improving blood supply to the skin (including the scalp), nourishing the skin, blackening hair and improving eyesight. It is mainly used to treat palpitations, insomnia, dizziness, premature whitening of hair, tinnitus, night sweats, scrofula, joint discomfort and other diseases.

[0017] Yam is the underground tuber of Dioscorea opposita Thunb. of the Dioscoreaceae family. Its aliases include Dioscorea opposita, Yuting, Xiucui, Ercao, and Jiuhuangjiang. It is neutral in nature and sweet in taste. It belongs to the lung, spleen, and kidney meridians. Its functions are: strengthening the spleen, tonifying the lung, consolidating the kidney and benefiting essence, moistening the skin and hair.

[0018] Alpinia oxyphylla is pungent and warm in nature and belongs to the kidney and spleen meridians. It has the effect of warming the kidney and astringing sperm. When used in combination with wolfberry, mulberry fruit, etc., it can enhance the effect of tonifying the liver and kidney and nourishing essence and blood.

[0019] Black soybean is sweet in taste and neutral in nature; it has the effects of strengthening the spleen and promoting diuresis, reducing swelling and relieving flatulence, nourishing the kidney yin, moistening the lung dryness, dispelling wind-heat and activating blood circulation to detoxify, stopping night sweats, and promoting hair growth and blackening.

[0020] Black sesame is the black seed of Sesamum indicum L. of the Pedaliaceae family. It is sweet and neutral in nature and has the functions of nourishing the liver and kidney, benefiting blood and moistening the intestine, promoting defecation, strengthening the stomach, protecting the liver, and promoting the growth of red blood cells. Research has found that the water extract of black sesame can promote the expression of tyrosinase and increase the synthesis of melanin, turning white hair black.

[0021] Angelica sinensis is sweet, pungent, and warm in nature. It belongs to the liver, heart, and spleen meridians. It has the functions of tonifying blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestine and promoting defecation.

[0022] Buddha's hand is pungent, bitter, and sour in taste and warm in nature. It belongs to the liver, spleen, stomach, and lung meridians. It has the functions of soothing the liver and regulating qi, harmonizing the stomach and relieving pain, and drying dampness and resolving phlegm.

[0023] Semen Ziziphi Spinosae is sweet and sour in taste and neutral in nature. It belongs to the liver, gallbladder, and heart meridians. It has the functions of nourishing the heart and tonifying the liver, calming the mind and tranquilizing the spirit, astringing sweating, and promoting the production of body fluid. It is used for restlessness and insomnia, palpitation and dreaminess, excessive sweating due to weakness, and thirst due to fluid impairment.

[0024] American ginseng is sweet and slightly bitter in taste, and cool in nature. It acts on the heart, lungs and kidneys meridians. It has the effects of replenishing qi and nourishing yin, clearing heat and promoting fluid production. It is used for qi deficiency and yin deficiency, virtual heat and fatigue, cough, asthma and bloody phlegm, internal heat and polydipsia, dry mouth and throat.

[0025] The present invention also relates to a preparation method of the above-mentioned pharmaceutical composition, comprising the following steps:

[0026] (1) Polygonatum sibiricum, Alpinia oxyphylla, Angelica sinensis, Citrus medica var. sarcodactylis, Ziziphus jujuba var. spinosa and American ginseng are pulverized, mixed, added with water and enzymes, enzymolyzed, heated, and filtered to obtain Extract 1;

[0027] (2) The remaining raw materials are pulverized, ultrasonically extracted with Solution A, and filtered to obtain Extract 2;

[0028] (3) Extract 1 and Extract 2 are mixed, concentrated and dried to obtain the pharmaceutical composition.

[0029] Preferably, the enzyme in step (1) is a mixed enzyme of cellulase, pectinase and xylanase, and the mass ratio of cellulase, pectinase and xylanase is 4-5:1-2:1.

[0030] Preferably, the addition amount of water in step (1) is 6-8 times the total mass of Polygonatum sibiricum, Alpinia oxyphylla, Angelica sinensis, Citrus medica var. sarcodactylis, Ziziphus jujuba var. spinosa and American ginseng, and the addition amount of enzyme is 0.5%-0.8% of the total mass of Polygonatum sibiricum, Alpinia oxyphylla, Angelica sinensis, Citrus medica var. sarcodactylis, Ziziphus jujuba var. spinosa and American ginseng.

[0031] Preferably, the temperature of enzymolysis in step (1) is 40-60°C, the time of enzymolysis is 1-2 h, the temperature of heating is 80-90°C, and the time of heating is 10-20 min.

[0032] Preferably, Solution A in step (2) is an ethanol aqueous solution with a mass concentration of 55%-65%, and the addition amount of Solution A is 7-9 times the total mass of the remaining raw materials.

[0033] Preferably, the temperature of ultrasonic extraction in step (2) is 40-60°C, the time of ultrasonic extraction is 2-3 h, and the ultrasonic power is 200-300 w.

[0034] The active ingredients of the above-mentioned drugs or homologous components of medicine and food are the material basis for hair growth or hair fixation. Increasing the dissolution rate and extraction rate of the active ingredients in the raw materials, promoting the digestion and absorption of the effective ingredients by the human body, and can increase the effect of the composition. By enzymolyzing and ultrasonically extracting the raw materials, the cell wall breaking rate can be increased, the effective ingredients in the cells can be fully exposed, the effective ingredients in the cells can directly contact the extraction solution, the dissolution rate of the active ingredients can be improved, and then it is convenient for the human body to absorb the effective substances.

[0035] The present invention also relates to the use of the above-mentioned pharmaceutical composition or the pharmaceutical composition prepared by the above-mentioned preparation method in the preparation of a drug having the effect of promoting hair growth and preventing hair loss.

[0036] Preferably, the dosage form of the drug is selected from any one of tablets, powders, pills, capsules, ointments and granules.

[0037] More preferably, in addition to the pharmaceutical composition, the drug may further contain a surfactant, a diluent (such as lactose, glucose, sucrose, mannitol, sorbitol, cellulose and glycine) or a lubricant (such as silica, talc, stearic acid and its magnesium or calcium salts, and polyethylene glycol). The tablets may further contain a binder, such as magnesium aluminum silicate, starch paste, gelatin, tragacanth, methylcellulose, sodium carboxymethylcellulose and polyvinylpyrrolidone, and if necessary, may further contain a pharmaceutical additive such as a disintegrant, for example, starch, agar, alginic acid or its sodium salt, a wetting agent, a coloring agent, a flavoring agent, a sweetening agent, etc. The tablets can be prepared by common methods of mixing, granulating or coating.

[0038] Compared with the prior art, the present invention has the following beneficial effects:

[0039] (1) The composition of the present invention is made with a suitable raw material ratio, has a reasonable compatibility, and has the effects of tonifying the liver and kidney, strengthening the spleen and nourishing the lung, promoting hair growth and preventing hair loss. This product can activate hair follicles and strengthen the development of the scalp.

[0040] (2) The composition of the present invention adopts a specific preparation process, which increases the dissolution rate and extraction rate of the active ingredients in the raw materials, and achieves a better effect of promoting hair growth and preventing hair loss.

[0041] (3) The composition of the present invention can be added to drugs, and direct consumption also has the effects of reducing hair loss, promoting hair growth, and restoring the normal function of atrophied hair follicle cells. Detailed embodiments

[0042] The present invention will be further described below in conjunction with specific embodiments, and the advantages and features of the present invention will become clearer with the description. However, these embodiments are merely exemplary and do not constitute any limitation to the scope of the present invention. Those skilled in the art should understand that without departing from the spirit and scope of the present invention, modifications or substitutions can be made to the details and forms of the technical solutions of the present invention, but these modifications and substitutions all fall within the protection scope of the present invention.

[0043] Example 1

[0044] A hair growth-promoting pharmaceutical composition, calculated by weight fraction, the raw materials are: 13 parts of polygonatum sibiricum, 13 parts of longan, 11 parts of wolfberry, 11 parts of mulberry, 7 parts of Chinese yam, 13 parts of red date, 11 parts of lily, 18 parts of black bean, 16 parts of black sesame, 7 parts of glossy privet fruit, 15 parts of semen alpiniae oxyphyllae, 14 parts of angelica sinensis, 4 parts of fingered citron, 10 parts of wild jujube seed, and 8 parts of American ginseng.

[0045] The preparation method of the above-mentioned pharmaceutical composition is as follows:

[0046] (1) Crush polygonatum sibiricum, semen alpiniae oxyphyllae, angelica sinensis, fingered citron, wild jujube seed, and American ginseng, mix them, add 7 times the water of the total mass of polygonatum sibiricum, semen alpiniae oxyphyllae, angelica sinensis, fingered citron, wild jujube seed, and American ginseng and 0.6% of the mixed enzyme (the mixed enzyme is cellulase, pectinase, and xylanase with a mass ratio of 4.5:1.5:1), carry out enzymatic hydrolysis at 50 °C for 1.5 h, then heat to 85 °C, heat for 15 min, filter, and obtain extract 1;

[0047] (2) Crush the remaining raw materials, add solution A which is 8 times the total mass of the remaining raw materials, and solution A is an ethanol aqueous solution with a mass concentration of 60%, carry out ultrasonic extraction at 50 °C for 3 h, the ultrasonic power is 250 w, filter, and obtain extract 2;

[0048] (3) Mix extract 1 and extract 2, concentrate, and dry to obtain the above-mentioned pharmaceutical composition.

[0049] Example 2

[0050] A hair growth-promoting pharmaceutical composition, calculated by weight fraction, the raw materials are: 10 parts of polygonatum sibiricum, 10 parts of longan, 10 parts of wolfberry, 10 parts of mulberry, 5 parts of Chinese yam, 10 parts of red date, 8 parts of lily, 10 parts of black bean, 10 parts of black sesame, 5 parts of glossy privet fruit, 10 parts of semen alpiniae oxyphyllae, 10 parts of angelica sinensis, 2 parts of fingered citron, 5 parts of wild jujube seed, and 5 parts of American ginseng.

[0051] The preparation method of the above-mentioned pharmaceutical composition is as follows:

[0052] (1) Crush polygonatum sibiricum, semen alpiniae oxyphyllae, angelica sinensis, fingered citron, wild jujube seed, and American ginseng, mix them, add 8 times the water of the total mass of polygonatum sibiricum, semen alpiniae oxyphyllae, angelica sinensis, fingered citron, wild jujube seed, and American ginseng and 0.8% of the mixed enzyme (the mixed enzyme is cellulase, pectinase, and xylanase with a mass ratio of 5:2:1), carry out enzymatic hydrolysis at 60 °C for 1 h, then heat to 90 °C, heat for 10 min, filter, and obtain extract 1;

[0053] (2) Crush the remaining raw materials, add solution A which is 9 times the total mass of the remaining raw materials, and solution A is an ethanol aqueous solution with a mass concentration of 65%, carry out ultrasonic extraction at 60 °C for 2 h, the ultrasonic power is 200 w, filter, and obtain extract 2;

[0054] (3) Mix the extract 1 and the extract 2, concentrate and dry them to obtain the said pharmaceutical composition.

[0055] Example 3

[0056] A pharmaceutical composition for preventing hair loss and promoting hair growth, by weight fraction, the raw materials are: 20 parts of polygonatum sibiricum, 20 parts of longan, 15 parts of wolfberry, 15 parts of mulberry, 10 parts of Chinese yam, 20 parts of red date, 12 parts of lily, 20 parts of black bean, 20 parts of black sesame, 10 parts of glossy privet fruit, 30 parts of semen albiziae, 20 parts of angelica sinensis, 15 parts of fingered citron, 15 parts of wild jujube seed and 20 parts of American ginseng.

[0057] The preparation method of the said pharmaceutical composition is as follows:

[0058] (1) Crush polygonatum sibiricum, semen albiziae, angelica sinensis, fingered citron, wild jujube seed and American ginseng, mix them, add 6 times the total mass of polygonatum sibiricum, semen albiziae, angelica sinensis, fingered citron, wild jujube seed and American ginseng of water and 0.5% of a mixed enzyme (the mixed enzyme is a cellulase, pectinase and xylanase with a mass ratio of 4:1:1), carry out enzymatic hydrolysis at 40°C for 2 h, then heat to 80°C, heat for 20 min, filter to obtain extract 1;

[0059] (2) Crush the remaining raw materials, add solution A which is 7 times the total mass of the remaining raw materials, and solution A is an ethanol aqueous solution with a mass concentration of 55%, carry out ultrasonic extraction at 40°C for 3 h, the ultrasonic power is 300 w, filter to obtain extract 2;

[0060] (3) Mix the extract 1 and the extract 2, concentrate and dry them to obtain the said pharmaceutical composition.

[0061] Comparative Example 1

[0062] A pharmaceutical composition for preventing hair loss and promoting hair growth, the difference from Example 1 is only that: 27 parts of semen albiziae, 0 part of fingered citron, 0 part of American ginseng.

[0063] Comparative Example 2

[0064] A pharmaceutical composition for preventing hair loss and promoting hair growth, the difference from Example 1 is only that: 0 part of semen albiziae, 9 parts of fingered citron, 18 parts of American ginseng.

[0065] Comparative Example 3

[0066] A pharmaceutical composition for preventing hair loss and promoting hair growth, the difference from Example 1 is only that: 15 parts of semen albiziae, 0 part of fingered citron, 12 parts of American ginseng.

[0067] Comparative Example 4

[0068] A pharmaceutical composition for preventing hair loss and promoting hair growth, the difference from Example 1 is only that: 15 parts of semen albiziae, 12 parts of fingered citron, 0 part of American ginseng.

[0069] Comparative Example 5

[0070] A hair growth-promoting pharmaceutical composition, which is only different from that of Example 1 in that the preparation method is different:

[0071] The preparation method of the pharmaceutical composition in this comparative example is as follows:

[0072] (1) Crush and mix all raw materials, add 7 times the total mass of the raw materials of water and 0.6% of the mixed enzyme (the mixed enzyme is cellulase, pectinase and xylanase with a mass ratio of 4.5:1.5:1), carry out enzymatic hydrolysis at 50 °C for 1.5 h, then heat to 85 °C, heat for 15 min, and filter to obtain the extract;

[0073] (2) Concentrate and dry the extract to obtain the pharmaceutical composition.

[0074] Comparative Example 6

[0075] A hair growth-promoting pharmaceutical composition, which is only different from that of Example 1 in that the preparation method is different:

[0076] The preparation method of the pharmaceutical composition in this comparative example is as follows:

[0077] (1) Crush all raw materials, add 8 times the total mass of the raw materials of Solution A, Solution A is an ethanol aqueous solution with a mass concentration of 60%, carry out ultrasonic extraction at 50 °C for 3 h, the ultrasonic power is 250 w, and filter to obtain the extract;

[0078] (3) Concentrate and dry the extract to obtain the pharmaceutical composition.

[0079] Comparative Example 7

[0080] A hair growth-promoting pharmaceutical composition, which is only different from that of Example 1 in that the preparation method is different:

[0081] In step (1), the mixed enzyme is cellulase, pectinase and β-glucanase with a mass ratio of 4.5:1.5:1.

[0082] Effect test

[0083] 1. Hair growth effect test

[0084] Select 200 patients with kidney deficiency-induced hair loss, and randomly divide them into 10 groups on average, with 20 people in each group. Take the pharmaceutical compositions of Examples 1-3 and Comparative Examples 1-7 respectively, take them orally with water once a day, 2 g each time, and take them continuously for 2 months. The treatment effects are divided into:

[0085] Cured: Hair loss is completely controlled, only a few hairs are occasionally shed during washing and combing, and fine new hair grows on the head. No recurrence is seen during the 6-month follow-up;

[0086] Improvement: Hair loss significantly reduced, no recurrence seen during 3-month follow-up;

[0087] Ineffective: No improvement seen in hair loss and concomitant symptoms.

[0088] Total effective rate = [(number of cured + number of improved) / 15] * 100%, and the test results are shown in Table 1.

[0089] Table 1 Hair growth effect

[0090] Number of cured patients Number of improved patients Number of ineffective patients Total effective rate (%) Example 1 10 9 1 95.0 Example 2 8 10 2 90.0 Example 3 9 10 1 95.0 Comparative Example 1 1 6 13 35.0 Comparative Example 2 1 9 10 50.0 Comparative Example 3 3 8 9 55.0 Comparative Example 4 1 6 13 35.0 Comparative Example 5 0 7 13 35.0 Comparative Example 6 0 6 14 30.0 Comparative Example 7 0 4 16 20.0

[0091] 2. Hair growth effect test

[0092] Select 100 patients with kidney deficiency-induced hair loss, and there are small areas of alopecia areata (i.e., skin lesions) on the top of the patients' heads. They are randomly divided into 5 groups with 20 people in each group. The pharmaceutical compositions prepared in Example 1 and Comparative Examples 1-4 are taken orally with water once a day, 2 g each time, and used continuously for 3 months. The clinical treatment effects are divided into:

[0093] (1) Cured: The skin lesions on the top of the head are restored, black hair grows in the hair loss area, the hair pulling test shows negative, and no hair loss symptoms appear again;

[0094] (2) Markedly effective: The skin lesions on the top of the head are restored, black hair grows in most of the hair loss areas, the terminal hair coverage rate is above 60%, the hair pulling test shows negative, and no hair loss symptoms appear again;

[0095] (3) Improved: Black hair grows in some of the hair loss areas, the terminal hair coverage rate is between 30% and 60%, and the hair pulling test shows negative or weakly positive;

[0096] (4) Ineffective: The hair loss symptoms are not improved or even worsened.

[0097] Total effective rate = (number of cured + number of markedly effective + number of improved) / 20 * 100%, and the results are shown in Table 2.

[0098] Table 2 Hair growth effect

[0099] Number of cured patients Number of markedly effective patients Number of improved patients Number of ineffective patients Total effective rate (%) Example 1 7 8 4 1 95.0 Comparative Example 1 1 3 5 11 45.0 Comparative Example 2 1 2 6 11 45.0 Comparative Example 3 0 2 8 10 50.0 Comparative Example 4 2 3 7 8 60.0

[0100] The above detailed description is a specific description of one of the feasible embodiments of the present invention. This embodiment is not intended to limit the patent scope of the present invention. Any equivalent implementation or modification without departing from the present invention should be included within the scope of the technical solution of the present invention.

Claims

1. A hair growth and hair strengthening pharmaceutical composition, characterized in that, By weight fraction, the raw materials of the pharmaceutical composition are: 10 - 20 parts of polygonatum sibiricum, 10 - 20 parts of longan, 10 - 15 parts of wolfberry, 10 - 15 parts of mulberry, 5 - 10 parts of Chinese yam, 10 - 20 parts of red date, 8 - 12 parts of lily, 10 - 20 parts of black soybean, 10 - 20 parts of black sesame, 5 - 10 parts of glossy privet fruit, 10 - 30 parts of semen alpiniae oxyphyllae, 10 - 20 parts of angelica sinensis, 2 - 15 parts of fingered citron, 5 - 15 parts of wild jujube seed, and 5 - 20 parts of American ginseng; The preparation method of the pharmaceutical composition comprises the following steps: (1) Crush polygonatum sibiricum, semen alpiniae oxyphyllae, angelica sinensis, fingered citron, wild jujube seed, and American ginseng, mix them, add water and enzyme, carry out enzymatic hydrolysis, heat, and filter to obtain extract 1; (2) Crush the remaining raw materials, extract them by ultrasonic wave with solution A, and filter to obtain extract 2; (3) Mix extract 1 and extract 2, concentrate, and dry to obtain the pharmaceutical composition; The enzyme in step (1) is a mixed enzyme of cellulase, pectinase, and xylanase, and the mass ratio of cellulase, pectinase, and xylanase is 4 - 5:1 - 2:1; The solution A in step (2) is an ethanol aqueous solution with a mass concentration of 55% - 65%, and the addition amount of solution A is 7 - 9 times the total mass of the remaining raw materials.

2. The pharmaceutical composition according to claim 1, wherein By weight fraction, the raw materials of the pharmaceutical composition are: 12 - 15 parts of polygonatum sibiricum, 12 - 15 parts of longan, 10 - 12 parts of wolfberry, 10 - 12 parts of mulberry, 6 - 8 parts of Chinese yam, 12 - 16 parts of red date, 10 - 12 parts of lily, 15 - 20 parts of black soybean, 15 - 20 parts of black sesame, 5 - 8 parts of glossy privet fruit, 12 - 18 parts of semen alpiniae oxyphyllae, 12 - 18 parts of angelica sinensis, 3 - 10 parts of fingered citron, 8 - 12 parts of wild jujube seed, and 5 - 10 parts of American ginseng.

3. A method for preparing the pharmaceutical composition according to any one of claims 1-2, characterized in that, Comprises the following steps: (1) Crush polygonatum sibiricum, semen alpiniae oxyphyllae, angelica sinensis, fingered citron, wild jujube seed, and American ginseng, mix them, add water and enzyme, carry out enzymatic hydrolysis, heat, and filter to obtain extract 1; (2) Crush the remaining raw materials, extract them by ultrasonic wave with solution A, and filter to obtain extract 2; (3) Mix extract 1 and extract 2, concentrate, and dry to obtain the pharmaceutical composition; The enzyme in step (1) is a mixed enzyme of cellulase, pectinase, and xylanase, and the mass ratio of cellulase, pectinase, and xylanase is 4 - 5:1 - 2:1; The solution A in step (2) is an ethanol aqueous solution with a mass concentration of 55% - 65%, and the addition amount of solution A is 7 - 9 times the total mass of the remaining raw materials.

4. The preparation method according to claim 3, characterized in that, The addition amount of water in step (1) is 6 - 8 times the total mass of polygonatum sibiricum, semen alpiniae oxyphyllae, angelica sinensis, fingered citron, wild jujube seed, and American ginseng, and the addition amount of enzyme is 0.5% - 0.8% of the total mass of polygonatum sibiricum, semen alpiniae oxyphyllae, angelica sinensis, fingered citron, wild jujube seed, and American ginseng.

5. The preparation method according to claim 3, characterized in that, The temperature of enzymatic hydrolysis in step (1) is 40 - 60 °C, the time of enzymatic hydrolysis is 1 - 2 h, the temperature of heating is 80 - 90 °C, and the time of heating is 10 - 20 min.

6. The preparation method according to claim 3, wherein The temperature of ultrasonic extraction in step (2) is 40 - 60 °C, the time of ultrasonic extraction is 2 - 3 h, and the ultrasonic power is 200 - 300 w.

7. Use of the pharmaceutical composition according to any one of claims 1-2 or the pharmaceutical composition prepared by the preparation method according to any one of claims 3-6 in the preparation of a drug having the effect of promoting hair growth and preventing hair loss.

8. The application according to claim 7, characterized in that, The dosage form of the drug is selected from any one of tablets, powders, pills, capsules, ointments and granules.