A pharmaceutical composition for treating alopecia and promoting hair growth and application thereof

Abstract

The application discloses a kind of drug combination for treating alopecia, promoting hair growth, which is prepared by extracting the following weight parts of traditional Chinese medicine: 6-15 parts of Artemisia Scoparia, 9-30 parts of Imperata Cylindrica, 6-15 parts of Polyporus, 3-15 parts of Curcuma, 9-15 parts of Albizia, 9-15 parts of Cassia Seed (fried), 3-15 parts of Red Flower, 6-15 parts of Lantana, 3-15 parts of Magnolia, 3-12 parts of Chuanxiong. The application also discloses the preparation method and application of the above-mentioned drug, and the drug composition has the effects of clearing heat and removing dampness, expelling wind and relieving itching, promoting blood circulation to remove meridian obstruction, cooling blood to calm the nerves, clearing liver and relieving depression, and nourishing hair and darkening beard. Pharmacological studies show that the treatment effect on androgenic alopecia is remarkable.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a pharmaceutical composition for treating hair loss and promoting hair growth, as well as its preparation method and application. Background Technology

[0002] Hair loss is a common and stubborn clinical condition, with androgenetic alopecia being the most prevalent type, accounting for over 90%. Androgenetic alopecia is a progressive disease, and its incidence is on the rise due to the increasing pace of work and life pressures in modern society. Its disfiguring characteristics cause significant mental stress and psychological burden for patients. Statistics show that the prevalence of androgenetic alopecia in my country is 21.3% in men and 6.0% in women, with a trend of increasing annually and affecting younger age groups.

[0003] Currently, only minoxidil and finasteride are approved by the US FDA for the treatment of hair loss. However, due to the chronic nature of androgenetic alopecia and the interaction of genetic and environmental factors, the clinical efficacy of these two drugs is limited, and they also have certain toxic side effects, such as allergic reactions and sexual dysfunction. Therefore, there is an urgent need to develop new, safe, and effective drugs for the treatment of androgenetic alopecia to compensate for the shortcomings of existing treatments. Summary of the Invention

[0004] The purpose of this invention is to fully utilize the advantages of traditional Chinese medicine in the prevention and treatment of hair loss, and to provide a pharmaceutical composition for treating hair loss and promoting hair growth, which has the effects of clearing heat and dampness, dispelling wind and relieving itching, promoting blood circulation and unblocking collaterals, cooling blood and calming the mind, clearing the liver and relieving depression, and promoting hair growth and darkening the beard. Another objective of this invention is to provide a method for preparing this pharmaceutical composition.

[0005] The present invention discloses a pharmaceutical composition for treating hair loss and promoting hair growth, which is prepared from the following Chinese herbal raw materials in parts by weight: Artemisia capillaris 6-15 parts, Imperata cylindrica root 9-30 parts, Polyporus umbellatus 6-15 parts, Curcuma longa 3-15 parts, Albizia julibrissin bark 9-15 parts, stir-fried Cassia tora seed 9-15 parts, Carthamus tinctorius 3-15 parts, Lycopus lucidus 6-15 parts, Magnolia biondii 3-15 parts, and Ligusticum chuanxiong 3-12 parts.

[0006] The pharmaceutical composition is made from the following Chinese herbal raw materials in parts by weight: Artemisia capillaris 12 parts, Imperata cylindrica 15 parts, Polyporus umbellatus 12 parts, Curcuma longa 12 parts, Albizia julibrissin bark 12 parts, stir-fried Cassia tora seed 12 parts, Carthamus tinctorius 12 parts, Lycopus lucidus 12 parts, Magnolia biondii 12 parts, and Ligusticum chuanxiong 10 parts.

[0007] Furthermore, it is a preparation made by adding pharmaceutically acceptable excipients or auxiliary ingredients to the aqueous extracts of various weight parts of traditional Chinese medicine raw materials.

[0008] Furthermore, the formulation is an oral formulation.

[0009] More preferably, the preparation is an oral liquid, granules, capsules, or tablets.

[0010] The preparation method of the aforementioned pharmaceutical composition for treating hair loss and promoting hair regrowth is as follows:

[0011] (1) Weigh out each part of the raw medicinal material, add water in an amount of 1-10 times (preferably 10 times) of the weight of the raw material, boil for 45-60 minutes (preferably 60 minutes), and filter out the first decoction; then add water in an amount of 1-9 times (preferably 9 times) of the weight of the raw material, boil for 35-50 minutes (preferably 45 minutes), and filter out the second decoction; then add water in an amount of 1-8 times (preferably 8 times) of the weight of the raw material, boil for 30-45 minutes (preferably 35 minutes), and filter out the third decoction;

[0012] (2) Combine the first, second and third medicinal solutions prepared in step (1) above to obtain crude extract of traditional Chinese medicine. Boil and concentrate the extract to a concentration with a relative density of 1.10-1.25 at 70°C, which is the concentrated extract of traditional Chinese medicine.

[0013] (3) Take the concentrated Chinese medicine solution prepared in step (2), freeze it into a solid state at (-10℃ to -50℃), and then freeze-dry it under vacuum (1.3-13Pa) to obtain a powdered drug extract.

[0014] The present invention also proposes a pharmaceutical composition comprising the powdered pharmaceutical extract as described above and a pharmaceutically acceptable carrier, said pharmaceutical composition being formulated into one of the following dosage forms: capsule, tablet, granule or oral liquid.

[0015] The present invention also proposes the application of the pharmaceutical composition in the preparation of drugs for treating hair loss and promoting hair growth, wherein the syndrome of hair loss is damp-heat stagnation.

[0016] The above-mentioned medicinal materials are all selected according to pharmacopoeia standards, and the functions and effects of each component are as follows:

[0017] Artemisia capillaris, or Artemisia scoparia Waldst. et Kit. or Artemisia capillaris Thunb., are the dried aerial parts of plants in the Asteraceae family. They taste bitter and pungent, and are slightly cold in nature. They enter the spleen, stomach, liver, and gallbladder meridians. They have the effects of clearing damp-heat, promoting bile secretion, and reducing jaundice.

[0018] Imperata cylindrica root is the dried rhizome of the grass Imperata cylindrica Beauv. var. major (Nees) CE Hubb. It has a sweet taste and cold properties. It enters the lung, stomach, and bladder meridians. It has the effects of cooling the blood and stopping bleeding, clearing heat and promoting diuresis.

[0019] Polyporus umbellatus, the dried sclerotium of the fungus Polyporus umbellatus (Pers.) Fries of the family Polyporaceae, is mild in flavor, sweet and bland in nature, attributive to the kidney and bladder meridians, and has the function of promoting diuresis and percolating dampness.

[0020] Turmeric, the dried tuberous roots of Curcuma wenyujin Y.H.Chen et C.Ling, Curcuma longa L., Curcuma kwangsiensis S.G.Lee et C.F.Liang or Curcuma phaeocaulis Val. of the family Zingiberaceae, is pungent, bitter and cold in nature, attributive to the liver, heart and lung meridians, and has the effects of promoting blood circulation to relieve pain, regulating qi to relieve depression, clearing the heart and cooling blood, and promoting bile secretion to remove jaundice.

[0021] Pericarpium Albiziae, the dried bark of Albizia julibrissin Durazz. of the family Leguminosae, is sweet in flavor and neutral in nature, attributive to the heart, liver and lung meridians, and is good at relieving depression and calming the mind, and promoting blood circulation to reduce swelling.

[0022] Fried Semen Cassiae, prepared from the dried ripe seeds of Cassia obtusifolia L. or Cassia tora L. of the family Leguminosae, is sweet, bitter and salty in flavor, slightly cold in nature, attributive to the liver and large intestine meridians, and has the effects of clearing heat and improving eyesight, and moistening the intestines and promoting defecation.

[0023] Flos Carthami, the dried flowers of Carthamus tinctorius L. of the family Compositae, is pungent in flavor and warm in nature, attributive to the heart and liver meridians, and has the effects of promoting blood circulation to dredge the channels and dispelling stasis to relieve pain.

[0024] Herba Lycopi, the dried aerial parts of Lycopus lucidus Turcz. var. hirtus Regel of the family Labiatae, is bitter, pungent and slightly warm in nature, attributive to the liver and spleen meridians, and has the effects of promoting blood circulation and regulating menstruation, dispelling stasis and eliminating carbuncles, and promoting diuresis and reducing swelling.

[0025] [[ID=!8]]Flos Magnoliae, the dried flower buds of Magnolia biondii Pamp., Magnolia denudata Desr. or Magnolia sprengeri Pamp. of the family Magnoliaceae, is pungent in flavor and warm in nature, attributive to the lung and stomach meridians, and has the effects of dispelling wind-cold and opening the nasal passages.

[0026] Rhizoma Chuanxiong, the dried rhizomes of Ligusticum chuanxiong Hort. of the family Umbelliferae, is pungent in flavor and warm in nature, attributive to the liver, gallbladder and pericardium meridians, and can both promote blood circulation and remove stasis and regulate qi to relieve pain, with the efficacy of promoting qi and blood circulation.

[0027] It should be noted that there was a misspelling in the original text where "归心、甘、肺经" in the description of "合欢皮" should be "归心、肝、肺经". The corrected content is used in the translation.Hair loss can be categorized into internal and external causes. External causes are mainly the direct invasion of pathogenic factors (wind, cold, dampness, heat, dryness, fire, and fire) or external skin damage, which alter the normal physiological state of the scalp and hair follicles, leading to hair loss. Internal causes are more complex and extensive. For example, irregular diet and inactivity can lead to the accumulation of phlegm and dampness, obstructing the flow of Qi and causing the scalp and hair follicles to lose their nourishment and resulting in hair loss. Dampness can also cause a damp scalp, excessive sweating, oily scalp, swelling, and papules and vesicles. Excessive sexual activity and childbirth can deplete the essence and blood of the liver and kidneys, leading to hair loss. Excessive emotional stress can disrupt the normal rhythm of the meridians, causing hair loss. Alternatively, congenital deficiencies and weak internal organs can affect the Qi and blood of the meridians, resulting in poor distribution and regulation of Qi and blood, leading to hair loss. Emotional distress and excessive emotional stress can transform into heat and fire, which in turn generates wind that rises to the top of the head, damaging Yin and blood. The resulting blood heat and dryness can scorch the hair follicles, causing hair to lose its nourishment and fall out. Because the causes of hair loss in modern people are complex, treatment can employ a variety of methods to address different causes, such as clearing heat and dampness, dispelling wind and relieving itching, promoting blood circulation and unblocking collaterals, cooling blood and calming the mind, clearing the liver and relieving depression, and promoting hair growth and darkening the beard.

[0028] Traditional Chinese medicine (TCM) offers unique advantages in preventing and treating hair loss, including holistic regulation and minimal side effects. TCM categorizes this condition as "hair loss due to insect infestation" or "hair loss due to tinea." From the perspective of pathogenic factors, the causes of hair loss in modern people are complex. External causes are mainly the direct invasion of pathogenic factors (such as the six external evils) or external skin damage, which alter the normal physiological state of the scalp's hair follicles, leading to hair loss. Internal causes are more complex and widespread. For example, many modern people have unhealthy lifestyle habits such as a preference for spicy and rich foods and laziness, leading to internal damp-heat that rises to the surface, eroding the hair roots and causing hair to fall out due to lack of nourishment. Dampness can also cause scalp dampness, papules, and itching. Modern young and middle-aged people often experience high work pressure, frequently stay up late, and have poor sleep, leading to liver stagnation and internal heat. Extreme heat generates wind, which in turn causes hair loss. Internal heat also causes pores to open, allowing wind to invade, eventually leading to pore blockage and hair loss due to lack of nourishment. Excessive sexual activity and childbirth deplete the liver and kidney essence and blood, resulting in hair loss. Excessive emotional stress disrupts the normal rhythm of the meridians, causing hair loss. Congenital deficiencies and weak internal organs can also affect the flow and regulation of qi and blood in the meridians, leading to hair loss. During hair growth, the five internal organs, meridians, and hair follicles work together in a chain-like relationship to promote and nourish the hair.

[0029] Therefore, damp-heat stagnation is the root cause of androgenetic alopecia, and wind-evil also invades the skin and hair. Therefore, the methods of clearing heat and dampness, dispelling wind and relieving itching, promoting blood circulation and unblocking collaterals, cooling blood and calming the mind, and clearing the liver and relieving depression are more conducive to achieving the goal of hair growth and blackening of the beard. However, no new drugs have yet been developed and promoted for clinical application.

[0030] In summary, guided by the theories of Traditional Chinese Medicine, and through literature review, experimental verification, and the inventors' creative contributions, this invention has screened and obtained the aforementioned drug composition for treating hair loss and promoting hair growth. It is formulated with ten carefully selected Chinese herbs: Artemisia capillaris, Imperata cylindrica root, Polyporus umbellatus, Curcuma longa, Albizia julibrissin bark, stir-fried Cassia tora seed, Carthamus tinctorius, Lycopus lucidus, Magnolia biondii, and Ligusticum chuanxiong. Artemisia capillaris serves as the principal herb, clearing heat and dampness, promoting bile secretion and reducing jaundice, and clearing heat and cooling the blood; Imperata cylindrica root cools the blood and stops bleeding, clears heat and promotes diuresis; Polyporus umbellatus promotes diuresis and eliminates dampness, serving as the assistant herbs; Carthamus tinctorius and Lycopus lucidus invigorate blood and unblock collaterals; Cassia tora seed and Curcuma longa clear the liver and relieve depression, invigorate blood and regulate qi, and clear the heart and cool the blood; Albizia julibrissin bark nourishes the heart and calms the mind; Magnolia biondii and Xanthium sibiricum dispel wind-cold, eliminate dampness and relieve itching; Ligusticum chuanxiong invigorates blood and guides the medicine upwards to the affected area, serving as the adjuvant herbs. The entire formula clears heat and dampness, dispels wind and relieves itching, invigorates blood and unblocks collaterals, cools the blood and calms the mind, thus treating hair loss caused by cavities and achieving the goal of promoting hair growth and darkening the beard. This preparation is not only safe and non-toxic, but also has significant effects in treating hair loss and promoting hair regrowth. The development of this preparation will bring benefits to hair loss patients, as well as huge economic benefits to related enterprises, and will also promote the rapid development of related industries. Attached Figure Description

[0031] Figure 1 This is a schematic diagram showing the effect of the pharmaceutical composition of the present invention on hair growth in a dihydrotestosterone-induced androgenic alopecia model mouse on day 17 after administration.

[0032] Figure 2 This is a dermoscopic diagram illustrating the effect of the pharmaceutical composition of this invention on hair growth in a dihydrotestosterone-induced androgenic alopecia model mouse.

[0033] Figure 3 This is a schematic diagram illustrating the effect of the pharmaceutical composition of the present invention on the skin and hair follicle status of a dihydrotestosterone-induced androgenic alopecia model mouse.

[0034] Figure 4 This is a schematic diagram illustrating the effect of the pharmaceutical composition of the present invention on the proliferation of hair follicle cells in a dihydrotestosterone-induced androgenic alopecia model mouse. Detailed Implementation

[0035] The following examples further illustrate the preparation of the pharmaceutical composition of the present invention and its efficacy in treating hair loss and promoting hair regrowth.

[0036] Example 1: Preparation of the pharmaceutical composition of the present invention

[0037] Take 12g of Artemisia capillaris, 15g of Imperata cylindrica root, 12g of Polyporus umbellatus, 12g of Curcuma longa, 12g of Albizia julibrissin bark, 12g of Cassia tora seed (fried), 12g of Carthamus tinctorius, 12g of Lycopus lucidus, 12g of Magnolia biondii, and 10g of Ligusticum chuanxiong. The preparation method is as follows:

[0038] (1) Weigh each of the raw materials by the stated weight, add water equal to 10 times the weight of the raw materials to the weighed raw materials, boil, decoct for 60 minutes and filter out the first decoction; add water equal to 9 times the weight of the raw materials, decoct for 45 minutes and filter out the second decoction; add water equal to 8 times the weight of the raw materials, decoct for 35 minutes and filter out the third decoction.

[0039] (2) The first, second and third medicinal solutions prepared in step (1) above are combined to obtain crude extract of traditional Chinese medicine, which is then decocted and concentrated to a concentrate with a relative density of 1.20 g / ml.

[0040] (3) Take the concentrated Chinese medicine solution obtained in step (2), freeze it into a solid at -30℃, and then freeze-dry it under vacuum of 1.3Pa to obtain a powdered drug extract. Add excipients to prepare it into granules.

[0041] Example 2: Preparation of the pharmaceutical composition of the present invention

[0042] Take 12g of Artemisia capillaris, 15g of Imperata cylindrica root, 12g of Polyporus umbellatus, 12g of Curcuma longa, 12g of Albizia julibrissin bark, 12g of Cassia tora seed (fried), 12g of Carthamus tinctorius, 12g of Lycopus lucidus, 12g of Magnolia biondii, and 10g of Ligusticum chuanxiong. The preparation method is as follows:

[0043] (1) Weigh each raw material component according to the stated weight, add water equal to 8 times the weight of the raw material to the weighed raw material, boil, decoct for 45 minutes and filter out the first decoction; add water equal to 8 times the weight of the raw material, decoct for 35 minutes and filter out the second decoction; add water equal to 8 times the weight of the raw material, decoct for 45 minutes and filter out the third decoction.

[0044] (2) The first, second and third medicinal solutions prepared in step (1) above are combined to obtain crude extract of traditional Chinese medicine, which is then decocted and concentrated to a concentrate with a relative density of 1.20 g / ml.

[0045] (3) Take the concentrated Chinese medicine solution obtained in step (2), freeze it into a solid at -30℃, and then freeze-dry it under vacuum at 8Pa to obtain a powdered drug extract. Add excipients to prepare granules.

[0046] Example 3: Preparation of the pharmaceutical composition of the present invention

[0047] Take 6g of Artemisia capillaris, 30g of Imperata cylindrica root, 6g of Polyporus umbellatus, 15g of Curcuma longa, 9g of Albizia julibrissin bark, 15g of stir-fried Cassia tora seed, 3g of Carthamus tinctorius, 15g of Lycopus lucidus, 3g of Magnolia biondii, and 12g of Ligusticum chuanxiong. The preparation method is as follows:

[0048] (1) Weigh each of the raw materials by the stated weight, add water equal to 10 times the weight of the raw materials to the weighed raw materials, boil, decoct for 60 minutes and filter out the first decoction; add water equal to 9 times the weight of the raw materials, decoct for 45 minutes and filter out the second decoction; add water equal to 8 times the weight of the raw materials, decoct for 35 minutes and filter out the third decoction.

[0049] (2) The first, second and third medicinal solutions prepared in step (1) above are combined to obtain crude extract of traditional Chinese medicine, which is then decocted and concentrated to a concentrate with a relative density of 1.20 g / ml.

[0050] (3) Take the concentrated Chinese medicine solution obtained in step (2), freeze it into a solid at -10℃, and then freeze-dry it under vacuum at 13Pa to obtain a powdered drug extract. Add excipients to prepare it into granules.

[0051] Example 4: Preparation of the pharmaceutical composition of the present invention

[0052] Take 15g of Artemisia capillaris, 9g of Imperata cylindrica root, 15g of Polyporus umbellatus, 3g of Curcuma longa, 15g of Albizia julibrissin bark, 9g of stir-fried Cassia tora seed, 15g of Carthamus tinctorius, 6g of Lycopus lucidus, 15g of Magnolia biondii, and 3g of Ligusticum chuanxiong. The preparation method is as follows:

[0053] (1) Weigh each of the raw materials by the stated weight, add water equal to 10 times the weight of the raw materials to the weighed raw materials, boil, decoct for 60 minutes and filter out the first decoction; add water equal to 9 times the weight of the raw materials, decoct for 45 minutes and filter out the second decoction; add water equal to 8 times the weight of the raw materials, decoct for 35 minutes and filter out the third decoction.

[0054] (2) The first, second and third medicinal solutions prepared in step (1) above are combined to obtain crude extract of traditional Chinese medicine, which is then decocted and concentrated to a concentrate with a relative density of 1.20 g / ml.

[0055] (3) Take the concentrated Chinese medicine solution obtained in step (2), freeze it into a solid at -50℃, and then freeze-dry it under vacuum at 8Pa to obtain a powdered drug extract. Add excipients to prepare it into granules.

[0056] Example 5: Pharmacodynamic experiment of the pharmaceutical composition of the present invention in promoting hair growth in mice

[0057] 1. Establishment of a dihydrotestosterone-induced androgenetic alopecia model in mice

[0058] Seventy-two male SPF-grade C57BL / 6 mice, weighing 18-22g, were used. Mice were housed under standard conditions: room temperature 20±2℃, relative humidity 40±5%, and a 12-hour light / dark cycle. After one week of acclimatization, the mice were divided into six groups of 12 mice each: a control group, a model group, a finasteride group, and groups containing the drug composition prepared in Example 1 of this invention (7.8g crude drug / kg, 15.7g crude drug / kg, and 31.4g crude drug / kg, respectively). Except for the control group, all other groups received intraperitoneal injections of 0.01ml / g dihydrotestosterone for four consecutive days. Following this, hair was removed under anesthesia to induce highly synchronized hair follicle development in the anagen phase. Subsequently, 0.01ml / g dihydrotestosterone was injected intraperitoneally five times weekly to maintain the androgenetic alopecia model.

[0059] 2. Hair growth in mice

[0060] Starting from day 2 of hair removal, medication was administered. The positive control group received 0.13 mg / kg finasteride by gavage, while the drug groups received different concentrations of the drug composition described in Example 1 by gavage. The blank control group and the model group received an equal volume of double-distilled water by gavage. Gross and dermoscopic photographs were taken of mice on the day of hair removal and on days 3, 7, 10, 14, 17, and 21 of medication. Hair growth on the backs of the mice was recorded, and skin color was scored as follows: pink, off-white, white, light gray, gray to dark gray, corresponding to scores of 1, 2, 3, 4, 5, and 6, respectively. To ensure photographic quality, all mice were anesthetized with isoflurane before photography. Gross photographs were taken under the same light source to ensure a consistent background. (See attached image). Figure 1 , Figure 2 Tables 1 and 2.

[0061] Table 1 Overall hair growth in mice

[0062]

[0063] Note: "-" indicates no hair growth; "+" indicates a small amount of fine downy hair; "++" indicates more obvious hair growth; "+++" indicates good hair growth; "++++" indicates hair growth is no different from that of normal mice.

[0064] Table 2. Mouse skin color (mean ± SD)

[0065]

[0066] Note: # * indicates that compared with the control group, P < 0.05, and the difference is statistically significant; * indicates that compared with the model group, P < 0.05, and the difference is statistically significant.

[0067] Figure 1 , Figure 2 As shown in Tables 1 and 2, after using dihydrotestosterone to establish the hair growth model, hair growth in all groups of mice except the control group was significantly inhibited. On day 17 after hair removal, the coverage rate of newly grown hair in the bald areas on the backs of some mice in the model group was still less than 50%, while the newly grown hair in the bald areas of the other groups was almost completely covered. This indicates that the pharmaceutical composition of the present invention is effective in promoting hair growth in mice and alleviating androgenetic alopecia.

[0068] 3. The pharmaceutical composition of the present invention promotes the increase of hair follicle diameter and skin thickness in mice.

[0069] H&E staining: Mouse dorsal skin tissue was fixed in 4% paraformaldehyde solution for 24 h, then dehydrated in a gradient, cleared, embedded in paraffin, and sectioned. After dewaxing and rehydration, sections were stained with hematoxylin for 3 min, rinsed with running water for 5 min; differentiated with 0.05% hydrochloric acid-ethanol for 10 s, rinsed with running water for 5 min; blued with 1% ammonia solution for 30 s, rinsed with running water for 5 min; stained with eosin for 3 min, rinsed with running water for 5 min; then dehydrated in a gradient of 50%, 75%, 95%, and 100% ethanol and xylene, 20 s each time; finally, the sections were mounted with a 1:1 mixture of xylene and neutral resin and air-dried in a fume hood. The sections were observed under a pathological microscope, and randomly selected fields of view were photographed. Results are shown below. Figure 3 And Tables 3 and 4.

[0070] Table 3. Changes in hair follicle diameter on the back of mice (μm) (mean±SD)

[0071]

[0072] Note: # * indicates that compared with the control group, P < 0.05, and the difference is statistically significant; * indicates that compared with the model group, P < 0.05, and the difference is statistically significant.

[0073] Table 4. Changes in skin thickness on the back of mice (μm) (mean±SD)

[0074]

[0075] Note: # * indicates that compared with the control group, P < 0.05, and the difference is statistically significant; * indicates that compared with the model group, P < 0.05, and the difference is statistically significant.

[0076] Figure 3As shown in Tables 3 and 4, compared with the control group, the hair follicle cells in the model group mice were disordered, varied in size, smaller in volume, and had significantly reduced hair follicle diameter and skin thickness. With increasing dosage of the drug composition, the hair follicle condition of the alopecia mice improved, with a significant increase in hair follicle diameter and skin thickness. This indicates that the drug composition of the experimental examples of this invention can improve the condition of the skin and hair follicles on the back of mice and alleviate androgenetic alopecia.

[0077] 4. The pharmaceutical composition of the present invention promotes the proliferation of mouse hair follicle papillary cells.

[0078] Immunofluorescence staining: Mouse dorsal tissue was dehydrated, embedded, sectioned, dewaxed, and rehydrated. Sections were then microwaved in antigen retrieval solution for 3 min on high and 7 min on medium-high. After natural cooling to room temperature, the sections were washed three times with PBS for 5 min each time. Sections were then blocked with 5% BSA and incubated at room temperature for 1.5 h, followed by washing three times with PBS for 5 min each time. Primary antibody was added to slides, and the slides were incubated overnight at 4°C in a humidified chamber, followed by washing three times with PBS for 5 min each time. Secondary antibody was added to slides, and the slides were incubated in the dark at room temperature for 2.5 h, followed by washing three times with PBS for 5 min each time. Hoechst staining was performed for 15 min, followed by washing three times with PBS for 5 min each time. Finally, a fluorescence quencher was added, and the slides were mounted with coverslips. The slides were observed under a fluorescence microscope, and randomly selected fields of view were photographed. Results are shown below. Figure 4 See Table 5.

[0079] Table 5. Ki67 positive (mean ± SD)

[0080]

[0081] Note: # * indicates that compared with the control group, P < 0.05, and the difference is statistically significant; * indicates that compared with the model group, P < 0.05, and the difference is statistically significant.

[0082] Figure 4 As shown in Table 5, compared with the blank group, the area of ​​Ki67-positive hair follicle cells in the model group mice was significantly reduced. With increasing dosage of the pharmaceutical composition prepared by the method in Example 1 of this invention, the abundance of Ki67-positive expression in the hair follicles of alopecia mice increased, and the cells were more tightly packed. This indicates that the pharmaceutical composition prepared by the method in Example 1 of this invention can promote hair growth by promoting the proliferation of mouse hair follicle cells.

Claims

1. A pharmaceutical composition for treating hair loss and promoting hair regrowth, characterized in that, The pharmaceutical composition is made from the following Chinese herbal raw materials in parts by weight: Artemisia capillaris 6-15 parts, Imperata cylindrica root 9-30 parts, Polyporus umbellatus 6-15 parts, Curcuma longa 3-15 parts, Albizia julibrissin bark 9-15 parts, stir-fried Cassia tora seed 9-15 parts, Carthamus tinctorius 3-15 parts, Lycopus lucidus 6-15 parts, Magnolia biondii 3-15 parts, and Ligusticum chuanxiong 3-12 parts.

2. The pharmaceutical composition according to claim 1, characterized in that, The pharmaceutical composition is made from the following Chinese herbal raw materials in parts by weight: Artemisia capillaris 12 parts, Imperata cylindrica 15 parts, Polyporus umbellatus 12 parts, Curcuma longa 12 parts, Albizia julibrissin bark 12 parts, stir-fried Cassia tora seed 12 parts, Carthamus tinctorius 12 parts, Lycopus lucidus 12 parts, Magnolia biondii 12 parts, and Ligusticum chuanxiong 10 parts.

3. The pharmaceutical composition according to claim 1, characterized in that, The preparation method is as follows: (1) Weigh the raw materials, add water in 1-10 times the weight of the raw materials, boil for 45-60 minutes, and filter out the first decoction; add water in 1-9 times the weight of the raw materials, boil for 35-50 minutes, and filter out the second decoction; add water in 1-8 times the weight of the raw materials, boil for 30-45 minutes, and filter out the third decoction. (2) Combine the first, second and third medicinal solutions obtained in step (1) and concentrate them to a concentration with a relative density of 1.10-1.25, which is the Chinese medicine concentrate. (3) Take the concentrated Chinese medicine solution prepared in step (2), freeze it into a solid state at -10℃ to -50℃, and then freeze-dry it under vacuum of 1.3-13Pa to obtain a powdered drug composition.

4. The pharmaceutical composition according to claim 3, characterized in that, The resulting powdered pharmaceutical composition and a pharmaceutically acceptable carrier are formulated into one of the following dosage forms: oral liquid, granules, capsules, or tablets.

5. The application of the pharmaceutical composition according to claim 1 in the preparation of a drug for treating hair loss and promoting hair growth, wherein the syndrome of hair loss is damp-heat stagnation.

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