Traditional Chinese medicine composition for treating alopecia areata as well as preparation method and application thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating alopecia areata and a preparation method and application thereof, and belongs to the technical field of traditional Chinese medicine preparations. The traditional Chinese medicine composition is prepared from the following components in parts by mass: 10 to 30 parts of radix rehmanniae recen, 10 to 30 parts of radix rehmanniae preparata, 10 to 30 parts of caulis spatholobi, 10 to 30 parts of caulis polygoni multiflori, 30 to 50 parts of radix astragali, 10 to 20 parts of rhizoma chuanxiong, 10 to 30 parts of radix paeoniae alba, 5 to 20 parts of rhizoma gastrodiae, 5 to 20 parts of cordyceps sinensis, 10 to 30 parts of herba ecliptae, 10 to 30 parts of mulberry and 5 to 20 parts of fructus chaenomelis. The effect is stronger, and no side effect exists. The tincture prepared by the invention is a pure external preparation without systemic toxicity, has no side effects such as hirsutism and skin atrophy after long-term use, and is especially suitable for sensitive scalp patients.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine preparations, and in particular relates to a traditional Chinese medicine composition for treating alopecia areata, and a preparation method and application thereof. Background Art

[0002] Alopecia areata (AA) is a common, inflammatory, non-scarring hair loss disorder. Its clinical features include: sudden onset of hair loss: clearly defined, round or oval patches of hair loss appear on the scalp, which in severe cases can progress to alopecia totalis (complete hair loss) or alopecia universalis (all body hair loss). Its pathological mechanism is a breakdown of the hair follicle's immune system, with CD8+ T lymphocytes attacking hair follicle stem cells through the IFN-γ / JAK-STAT pathway, causing the hair follicles to prematurely enter the catagen phase. Psychological impacts: Approximately 50% of patients experience anxiety, depression, and other psychological issues, which severely impact their quality of life.

[0003] Currently, the commonly used Western medicine treatment options and their side effects are as follows:

[0004] Minoxidil: Single efficacy: only effective for mild alopecia areata (effectiveness <50%), almost ineffective for alopecia totalis and alopecia universalis; local side effects: 30% of patients experience contact dermatitis and scalp itching, and long-term use can lead to hypertrichosis (abnormal growth of hair on the face and limbs); drug resistance: the efficacy decreases significantly after 6 months of continuous use.

[0005] Corticosteroids: Limitations: Short-term dependence: Intralesional injection can only maintain efficacy for 4-6 weeks and requires repeated treatment; Skin side effects: Long-term use leads to skin atrophy, capillary dilation, and even secondary infection; Systemic risks: Oral or intravenous injection may cause Cushing's syndrome and osteoporosis.

[0006] JAK inhibitors (such as tofacitinib, baricitinib): Limitations: Systemic toxicity: Oral preparations are prone to cause serious infections (pneumonia, herpes zoster), dyslipidemia and cardiovascular events; Local dosage form defects: Topical creams have low transdermal efficiency (<5% of the drug penetrates into the hair follicles) and poor stability (easily degraded by light).

[0007] Traditional Chinese medicine (TCM) is based on the principle of "nourishing blood and tonifying the kidney, dispelling wind and activating blood circulation" for the treatment of alopecia areata, and has the advantage of multi-target regulation. However, existing research has the following shortcomings: single compound compatibility: most prescriptions focus on "nourishing blood and promoting hair growth" and ignore the synergistic effect of "immune regulation-microcirculation improvement"; poor dosage form adaptability: traditional water decoctions are inconvenient for external application, and ordinary tinctures have a fixed ethanol concentration (usually 60-70%), which leads to an imbalance in the dissolution of water-soluble components (such as polysaccharides) and alcohol-soluble components (such as flavonoids), affecting the efficacy.

[0008] Existing Western medicines, due to their single target and significant side effects, are unable to meet long-term treatment needs. Traditional Chinese medicine compounds, however, are limited by their crude manufacturing process and formulation design flaws, preventing them from fully exerting their therapeutic efficacy. Therefore, there is an urgent need to develop a safe and effective topical Chinese medicine compound formulation that combines immune regulation with hair follicle repair. By optimizing the preparation process to maximize the utilization of the ingredients, this could provide a new solution for patients with alopecia areata. Summary of the Invention

[0009] In view of this, the object of the present invention is to provide a Chinese medicine composition for treating alopecia areata and its preparation method and application.

[0010] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0011] The present invention provides a traditional Chinese medicine composition for treating alopecia areata, comprising the following components in parts by weight:

[0012] 10-30 parts of raw rehmannia root, 10-30 parts of cooked rehmannia root, 10-30 parts of millettia reticulata, 10-30 parts of radix polygoni multiflori, 30-50 parts of astragalus, 10-20 parts of ligusticum chuanxiong, 10-30 parts of white peony root, 5-20 parts of rhizoma tiliaceae, 5-20 parts of cordyceps sinensis, 10-30 parts of herba ecliptae, 10-30 parts of mulberry, and 5-20 parts of papaya.

[0013] Preferably, the following components are included in parts by mass:

[0014] 15-25 parts of raw rehmannia root, 15-25 parts of prepared rehmannia root, 15-25 parts of millettia reticulata, 15-25 parts of radix polygoni multiflori, 35-45 parts of astragalus, 12-18 parts of chuanxiong, 15-25 parts of white peony root, 8-16 parts of rhizoma tiliaceae, 8-16 parts of cordyceps, 15-25 parts of herba ecliptae, 15-25 parts of mulberry, and 8-16 parts of papaya.

[0015] Preferably, the following components are included in parts by mass:

[0016] 20 parts of Radix Rehmanniae, 20 parts of Radix Rehmanniae Preparata, 20 parts of Caulis Spatholobi, 20 parts of Caulis Polygoni Multiflori, 40 parts of Radix Astragali, 15 parts of Rhizoma Chuanxiong, 20 parts of the White Peony Roots, 12 parts of Rhizoma Cibotii, 12 parts of Cordyceps Sinensis, 20 parts of Herba Ecliptae, 20 parts of Fructus Mori, 12 parts of Chaenomeles sinensis.

[0017] The present invention provides application of the traditional Chinese medicine composition in preparing medicine for treating alopecia areata.

[0018] The present invention provides application of the traditional Chinese medicine composition in preparing antidepressant medicines.

[0019] Preferably, the dosage form of the drug includes tincture, spray or cream.

[0020] The present invention provides a tincture for treating alopecia areata. The preparation method of the tincture comprises the following steps:

[0021] 1) mixing the Chinese medicine composition with water, decocting for 1 to 5 times, combining the decoctions, filtering to obtain a filtrate, and concentrating under reduced pressure to a density of 1.2 to 1.4 g / mL to obtain an extract;

[0022] 2) mixing the extract with 60% to 80% ethanol in a mass ratio of 1:2 to 6, and allowing the mixture to stand to obtain a tincture.

[0023] Preferably, the mass ratio of the traditional Chinese medicine composition to water in step 1) is 1:5-10.

[0024] Preferably, the vacuum degree of the reduced pressure concentration in step 1) is -0.10 to -0.01 MPa, and the temperature is 50 to 70°C.

[0025] Preferably, the step 2) of allowing to stand is to allow to stand in a sealed and light-proof environment.

[0026] Compared with the prior art, the present invention has the following beneficial effects:

[0027] The present invention provides a Chinese medicine composition for treating alopecia areata, its preparation method and application, breaking through the single mechanism of action of Western medicine, and synergistically intervening through the triple pathway of "immunomodulation-angiogenesis-hair follicle repair", with stronger effects and no side effects. The tincture prepared by the present invention is a pure external preparation without systemic toxicity, and has no side effects such as hirsutism and skin atrophy with long-term use. It is especially suitable for patients with sensitive scalp. The preparation method of the tincture is free of water-polluting organic solvents throughout the process, realizing a green production process and meeting the needs of industrial production. In addition, the present invention can also be made into various dosage forms such as sprays and patches, with flexible dosage forms and convenient use. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 Comparison of body weight changes of mice in each group after treatment;

[0029] Figure 2 The following are photos comparing the hair growth of mice in each group after treatment;

[0030] Figure 3 Comparison of immune cell infiltration in each group of mice after treatment;

[0031] Figure 4 Comparison of movement trajectories in the open field test after treatment in each group of mice;

[0032] Figure 5 Comparison of immobility time in the forced swimming test after treatment in each group of mice. DETAILED DESCRIPTION

[0033] The present invention provides a traditional Chinese medicine composition for treating alopecia areata, comprising the following components in parts by weight:

[0034] 10-30 parts of raw Rehmannia root, preferably 15-25 parts, more preferably 20 parts;

[0035] 10-30 parts of Rehmannia root, preferably 15-25 parts, more preferably 20 parts;

[0036] 10-30 parts of Millettia reticulata, preferably 15-25 parts, more preferably 20 parts;

[0037] 10-30 parts of Polygonum multiflorum, preferably 15-25 parts, more preferably 20 parts;

[0038] 30-50 parts of Astragalus, preferably 35-45 parts, more preferably 40 parts;

[0039] 10-20 parts of Chuanxiong, preferably 12-18 parts, more preferably 15 parts;

[0040] 10-30 parts of white peony root, preferably 15-25 parts, more preferably 20 parts;

[0041] 5 to 20 parts of Mingma, preferably 8 to 16 parts, more preferably 12 parts;

[0042] 5-20 parts of Cordyceps sinensis, preferably 8-16 parts, more preferably 12 parts;

[0043] 10-30 parts of Eclipta prostrata, preferably 15-25 parts, more preferably 20 parts;

[0044] 10-30 parts of mulberries, preferably 15-25 parts, more preferably 20 parts;

[0045] 5 to 20 parts of papaya, preferably 8 to 16 parts, more preferably 12 parts.

[0046] The present invention provides the use of the traditional Chinese medicine composition in the preparation of a medicament for treating alopecia areata. The present invention not only conforms to the principle of compatibility of monarch, minister, assistant and envoy in traditional Chinese medicine, but also meets the requirements of modern medicine for efficacy evaluation and safety assessment. The monarch drugs (raw rehmannia root and cooked rehmannia root): target the root cause of alopecia areata, "liver and kidney yin deficiency", repair hair follicle immune immunity, and restore the hair growth cycle; raw rehmannia root: has a cold nature and a sweet and bitter flavor, clears heat and cools blood, nourishes yin and promotes fluid production, and inhibits hair follicle inflammatory response (reducing IL-6 and TNF-α); cooked rehmannia root: has a slightly warm nature and a sweet flavor, replenishes blood and yin, nourishes essence and fills marrow, and promotes the proliferation of hair follicle stem cells. Ministerial herbs (Spatholobus spatholobus, Polygonum multiflorum, Astragalus membranaceus, and Ligusticum chuanxiong): Work in synergy with the monarch herbs to address qi and blood stasis, opening up nutrient supply pathways for hair follicles. Spatholobus spatholobus: Invigorates and replenishes blood, relaxes tendons and activates collaterals, and improves hair follicle microcirculation (increasing local blood flow). Polygonum multiflorum: Nourishes blood and calms the mind, dredges and dispels wind, and promotes melanocyte activity. Astragalus membranaceus: Invigorates qi and raises yang, strengthens the surface and regenerates muscles, and enhances the metabolic function of hair papilla cells. Ligusticum chuanxiong: Invigorates blood circulation and qi, dispels wind and relieves pain, and promotes angiogenesis in hair follicles. Adjuvant herbs (White Peony Root, Rhizoma Cimicifugae, Cordyceps sinensis, and Eclipta prostrata): Address concurrent symptoms such as wind-dryness and immune imbalance, enhancing the overall stability of the formula. White Peony Root: Soothes the liver and relieves pain, calms liver yang, and alleviates scalp itching caused by blood deficiency and wind-dryness. Tianma: Calms wind and stops spasms, unblocks meridians and relieves pain, and inhibits neurogenic inflammation. Cordyceps: Tonifies the kidneys and lungs, regulates the Treg / Th17 immune balance, and reduces autoimmune attacks on hair follicles. Eclipta Prostrata: Tonifies the liver and kidneys, cools blood and stops bleeding, and prevents capillary leakage caused by excessive blood circulation. Enhancing herbs (mulberry and papaya): Direct the various herbs directly to the hair follicles, reducing irritation and improving patient compliance. Mulberry: Nourishes yin and moistens dryness, promotes fluid production and quenches thirst, alleviating the drying irritation of ethanol on the scalp. Papaya: Relaxes the tendons and activates the meridians, harmonizes the stomach and eliminates dampness, and promotes transdermal absorption.

[0047] The present invention provides application of the traditional Chinese medicine composition in preparing antidepressant medicines.

[0048] In the present invention, the dosage form of the drug preferably includes tincture, spray or cream.

[0049] The present invention provides a tincture for treating alopecia areata. The preparation method of the tincture comprises the following steps:

[0050] 1) mixing the Chinese medicine composition with water, decocting for 1 to 5 times, combining the decoctions, filtering to obtain a filtrate, and concentrating under reduced pressure to a density of 1.2 to 1.4 g / mL to obtain an extract;

[0051] 2) mixing the extract with 60% to 80% ethanol in a mass ratio of 1:2 to 6, and allowing the mixture to stand to obtain a tincture.

[0052] In the present invention, the traditional Chinese medicine composition is mixed with water, decocted for 1 to 5 times, the decoctions are combined, filtered to obtain a filtrate, and concentrated under reduced pressure to a density of 1.2 to 1.4 g / mL to obtain an extract. Before the Chinese medicine composition is mixed with water, the Chinese medicine is preferably crushed to 10-50 mesh, more preferably 20-40 mesh, and even more preferably 30 mesh; the mass ratio of the Chinese medicine composition to water is preferably 1:5-10, more preferably 1:6-9, and even more preferably 1:8; the number of decoctions is 1-5 times, preferably 2-4 times, and even more preferably 3 times; the temperature for the reduced pressure concentration is preferably 50-70°C, more preferably 55-65°C, and even more preferably 60°C; the vacuum degree is preferably -0.10-0.01 MPa, more preferably -0.08-0.03 MPa, and even more preferably -0.05 MPa; the time for the reduced pressure concentration is preferably 2-4 hours, more preferably 2.5-3.5 hours, and even more preferably 3 hours; the density of the extract is 1.2-1.4 g / mL (25°C), preferably 1.25-1.35 g / mL (25°C), and even more preferably 1.3 g / mL (25°C);

[0053] In the present invention, the extract is mixed with 60% to 80% ethanol by volume in a mass ratio of 1:2 to 6, and allowed to stand to obtain a tincture. The volume concentration of ethanol is preferably 60% to 80%, more preferably 65% to 75%, and even more preferably 70%; the mass ratio of the extract to ethanol is preferably 1:2 to 6, more preferably 1:3 to 5, and even more preferably 1:4; the mixing is performed by uniformly stirring the extract and the ethanol solution; the standing is preferably performed in a sealed, light-proof manner, and the standing time is preferably 10-20 days, more preferably 14 to 16 days, and even more preferably 15 days.

[0054] The technical solutions provided by the present invention are described in detail below with reference to the embodiments, but they should not be construed as limiting the scope of protection of the present invention.

[0055] Example 1

[0056] Drug composition:

[0057] 20g of raw Rehmannia root, 20g of cooked Rehmannia root, 20g of Millettia reticulata, 20g of Polygonum multiflorum root, 40g of Astragalus root, 15g of Chuanxiong root, 20g of white peony root, 12g of Tianma root, 12g of Cordyceps sinensis, 20g of Eclipta prostrata, 20g of mulberry fruit, and 12g of papaya.

[0058] Preparation method:

[0059] (1) Crush the root and tuber medicinal materials such as raw Rehmannia root, cooked Rehmannia root, white peony root, Chuanxiong, angelica sinensis, cordyceps sinensis, papaya and other insect and fungal medicinal materials into 20 mesh respectively;

[0060] Crush the stems, vines, herbs and fruits of Millettia reticulata, Polygonum multiflorum, Astragalus membranaceus, Eclipta tenuifolia and Morus alba into 30 meshes respectively;

[0061] The above medicinal materials are mixed evenly in the following mass proportions: 20g of raw rehmannia root, 20g of prepared rehmannia root, 20g of millettia spatholobi, 20g of radix polygoni multiflori, 40g of astragalus, 15g of ligusticum chuanxiong, 20g of white peony root, 12g of rhizoma lanatidis, 12g of cordyceps sinensis, 20g of herba ecliptae, 20g of mulberry, and 12g of papaya to prepare a mixed medicinal material powder.

[0062] (2) Take the mixed powder of medicinal materials and decoct it three times. For the first decoction, add 8 times the weight of water, boil it and keep it simmering for 40 minutes, filter it and set aside; for the second and third decoctions, add 6 times the weight of water to the medicinal residue and decoct it for 30 minutes each time. Combine the three filtrates to obtain a combined filtrate.

[0063] (3) The combined filtrate was concentrated at 60-70° C. and vacuum degree -0.05 MPa to a relative density of 1.30-1.35 (25° C.) to obtain an extract (water content 20-25%).

[0064] (4) Mix the extract with 70% ethanol at a mass ratio of 1:4 and stir until completely dissolved; seal and keep away from light for 14-16 days, take the supernatant and filter it to prepare the Chinese medicine tincture.

[0065] Example 2: Comparative Example of Drug Reduction

[0066] In order to confirm the importance of Polygonum multiflorum and Tianma ma, which were first used in the treatment of alopecia areata, in this prescription, a drug reduction comparison was set up to compare the effect with the complete prescription. In the drug reduction comparison, Polygonum multiflorum and Tianma ma were deleted from the prescription, namely:

[0067] 20g of raw Rehmannia root, 20g of cooked Rehmannia root, 20g of Millettia reticulata, 40g of Astragalus membranaceus, 15g of Chuanxiong, 20g of white peony root, 12g of Cordyceps sinensis, 20g of Eclipta prostrata, 20g of mulberry, and 12g of papaya.

[0068] The remaining operations are the same as in Example 1 to prepare the drug-reducing tincture.

[0069] Example 3 Dressing Change Comparison

[0070] Similarly, although the drug reduction ratio can prove that the Chinese herbal tincture formula is indispensable and confirms the importance of the completeness of the formula, it cannot prove its uniqueness. Therefore, in the drug replacement ratio, based on the efficacy and medicinal properties of these two herbs, Polygonum multiflorum is replaced with Ziziphus jujuba seeds, which have a calming effect, and Millettia reticulata, which has a meridian-opening effect (i.e., the Millettia reticulata ratio in the original formula is increased); Tianma is replaced with Uncaria rhynchophylla, which has a liver-calming effect, and Bombyx batryticatus, which has a wind-relieving effect, that is:

[0071] 20g of raw Rehmannia root, 20g of cooked Rehmannia root, 30g of Millettia reticulata, 10g of Ziziphus jujuba seed, 40g of Astragalus membranaceus, 15g of Ligusticum chuanxiong, 20g of white peony root, 8g of Uncaria rhynchophylla, 4g of Bombyx batryticatus, 12g of Cordyceps sinensis, 20g of Houttuynia cordata, 20g of Morus alba, and 12g of Papaya.

[0072] The remaining operations are the same as in Example 1 to prepare the medicine-changing tincture.

[0073] Experimental Example 1: Effect of continuous drug administration on alopecia areata model in mice

[0074] (1) Sixty 6-8 week old C57 male mice were selected and fed adaptively for 3-7 days. 50 mice were randomly selected and applied with imiquimod cream daily for 7 days to induce alopecia areata. The remaining mice were applied with petroleum jelly for 7 days. The mice were then observed for hair loss, body weight, and local inflammatory cytokine levels, indicating that the model was successful.

[0075] (2) Fifty mice with alopecia areata model were randomly divided into five groups: model group, minoxidil group, Chinese medicine tincture group, reduced-drug control group, and changed-drug control group, with 10 mice in each group.

[0076] (3) For 14 days, the blank group was smeared with vaseline, the model group was smeared with vaseline, the positive control group was smeared with minoxidil, the Chinese medicine tincture group was smeared with Chinese medicine tincture, the reduced-dose control group was smeared with reduced-dose tincture, and the changed-dose control group was smeared with changed-dose tincture.

[0077] (4) Apply imiquimod cream every 2 days to enhance the continuity of the model.

[0078] (5) During the 14-day treatment, the weight and hair growth of mice in each group were recorded for comparison. Figure 1 , hair growth details see Figure 2 .

[0079] Figure 1 Compared with the blank group, the body weight of the model group decreased significantly (P<0.05). Compared with the model group, the body weight of the TCM tincture group increased significantly (P<0.05), the minoxidil group increased slightly (P>0.05), and the reduced-dose control group and the changed-dose control group increased slightly (P>0.05). Compared with the positive control group, the body weight of the TCM tincture treatment group increased significantly (P<0.05), while the difference between the reduced-dose control group and the changed-dose control group was not significant (P>0.05).

[0080] Figure 2 The results showed that after the treatment, although the hair of the minoxidil group, the reduced-dose control group and the changed-dress control group had grown compared with before treatment, the hair was sparse and dull, and some areas still had no new hair; while the new hair in the Chinese medicine tincture group was thick and shiny.

[0081] (6) Sample collection and immunohistochemistry testing after the treatment

[0082] After the treatment, mice were screened for CD4 + and CD8 + T cell immunohistochemistry detection:

[0083] 1. Sample Collection and Tissue Preparation

[0084] After the mice in each group were killed, skin tissues from the alopecia areata area were quickly collected, fixed with 4% paraformaldehyde for 24 hours, embedded in paraffin, and serially sectioned (about 4 μm thick) for immunohistochemical staining.

[0085] 2. Immunohistochemistry (IHC)

[0086] Tissue sections were dewaxed and hydrated, and antigen retrieval was performed at high temperature using citrate buffer. Endogenous peroxidase activity was blocked with hydrogen peroxide and blocked with 5% goat serum. Primary antibodies, anti-CD4 and anti-CD8, were added (diluted according to the manufacturer's instructions) and incubated overnight at 4°C. The following day, the sections were washed with PBS and then treated with secondary antibodies. The sections were then developed with DAB, counterstained with hematoxylin, and dehydrated and mounted.

[0087] 3. Image Acquisition

[0088] Images were taken using a microscope (×200 or ×400 magnification), and image analysis software such as ImageJ was used to observe the CD4 + and CD8 + Cell staining intensity and distribution.

[0089] 4. Results Analysis

[0090] like Figure 3 As shown, a large number of CD4 + and CD8 + Positive cell infiltration indicated that the local inflammatory reaction was obvious; the number of inflammatory cells in the minoxidil group, the reduced-dose control group, and the changed-dress control group was significantly reduced; the CD4 + / CD8 + The expression level was close to that of the blank group, indicating that the inflammation had basically subsided and the treatment effect was better than that of other groups.

[0091] (7) Determination of behavioral characteristics of mice

[0092] In order to evaluate the effect of drugs on improving antidepressant-like behavior in mice, the following classic behavioral test methods were used:

[0093] 1. Forced Swim Test

[0094] Mice were individually placed in a transparent cylindrical container approximately 20 cm in diameter, 25 cm high, and 15 cm deep, at a temperature of approximately 25 ± 1°C. The test lasted for 6 minutes. The first 2 minutes were an acclimatization period, and the remaining 4 minutes were used to measure the duration of immobility (only the head remained above the water, the body was no longer struggling). A reduction in immobility time is considered to have an antidepressant-like effect.

[0095] 2. Open field test

[0096] Mice are placed in an open square experimental box (e.g., 50 cm x 50 cm), and a video tracking system is used to record the total distance moved, the time spent in the center area, and the number of entries within 5 minutes. Antidepressant treatment often improves the decreased activity.

[0097] The results are as follows Figure 4 and Figure 5 As shown;

[0098] Figure 4 The results showed that compared with the blank group, the model group had significantly reduced movement trajectories; the minoxidil group, the reduced-dose control group, and the changed-dose control group had increased movement trajectories, but were much smaller than those in the TCM tincture group. This suggests that the TCM tincture group can restore depression in mice.

[0099] Figure 5 The results showed that compared with the blank group, the immobility time in the model group was significantly increased (P<0.05). Although the time in the minoxidil group, the reduced-dose treatment group and the dressing-change control group decreased, the effect was not as good as that in the Chinese medicine tincture group (P<0.05).

[0100] Conclusion: The external application of the compound Chinese medicine tincture in the embodiment of the present invention can significantly improve the alopecia areata condition in mice and also improve their depression to a certain extent, and the effect is significantly higher than that of other control groups.

[0101] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the present invention. These improvements and modifications should also be regarded as within the scope of protection of the present invention.

Claims

1. A Chinese medicine composition for treating alopecia areata, characterized in that: The composition includes the following parts by mass: 10-30 parts of raw rehmannia root, 10-30 parts of cooked rehmannia root, 10-30 parts of millettia reticulata, 10-30 parts of radix polygoni multiflori, 30-50 parts of astragalus, 10-20 parts of ligusticum chuanxiong, 10-30 parts of white peony root, 5-20 parts of rhizoma tiliaceae, 5-20 parts of cordyceps sinensis, 10-30 parts of herba ecliptae, 10-30 parts of mulberry, and 5-20 parts of papaya.

2. The Chinese medicine composition according to claim 1, characterized in that The composition includes the following parts by mass: 15-25 parts of raw rehmannia root, 15-25 parts of prepared rehmannia root, 15-25 parts of millettia reticulata, 15-25 parts of radix polygoni multiflori, 35-45 parts of astragalus, 12-18 parts of chuanxiong, 15-25 parts of white peony root, 8-16 parts of rhizoma tiliaceae, 8-16 parts of cordyceps, 15-25 parts of herba ecliptae, 15-25 parts of mulberry, and 8-16 parts of papaya.

3. The Chinese medicine composition according to claim 2, characterized in that The composition includes the following parts by mass: 20 parts of Radix Rehmanniae, 20 parts of Radix Rehmanniae Preparata, 20 parts of Caulis Spatholobi, 20 parts of Caulis Polygoni Multiflori, 40 parts of Radix Astragali, 15 parts of Rhizoma Chuanxiong, 20 parts of the White Peony Roots, 12 parts of Rhizoma Cibotii, 12 parts of Cordyceps Sinensis, 20 parts of Herba Ecliptae, 20 parts of Fructus Mori, 12 parts of Chaenomeles sinensis.

4. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating alopecia areata.

5. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of antidepressant drugs.

6. The use according to claim 4 or 5, characterized in that The dosage form of the drug includes tincture, spray or cream.

7. A tincture for treating alopecia areata, characterized in that The preparation method of the tincture comprises the following steps: 1) mixing the Chinese medicine composition according to any one of claims 1 to 3 with water, decocting for 1 to 5 times, combining the decoctions, filtering to obtain a filtrate, and concentrating under reduced pressure to a density of 1.2 to 1.4 g / mL to obtain an extract; 2) mixing the extract with 60% to 80% ethanol in a mass ratio of 1:2 to 6, and allowing the mixture to stand to obtain a tincture.

8. The tincture according to claim 7, characterized in that The mass ratio of the traditional Chinese medicine composition to water in step 1) is 1:5-10.

9. The tincture according to claim 7, characterized in that The vacuum degree of the reduced pressure concentration in step 1) is -0.10 to -0.01 MPa, and the temperature is 50 to 70°C.

10. The tincture according to claim 7, characterized in that The step 2) is to place the container in a sealed container away from light.

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