Use of a traditional Chinese medicine compound in the preparation of a medicament for treating or improving alopecia

Abstract

This invention discloses the application of a traditional Chinese medicine compound in the preparation of a drug for treating or improving hair loss, belonging to the field of traditional Chinese medicine technology. The traditional Chinese medicine composition consists of the following raw materials in the following proportions: 10-15 parts of white peony root, 6-10 parts of bupleurum root, 10-15 parts of prepared rehmannia root, 15-20 parts of stir-fried yam, 12 parts of dodder seed, 10 parts of angelica root, 10 parts of poria cocos, 12 parts of privet fruit, 10-15 parts of salvia miltiorrhiza root, 10-12 parts of cornus fruit, and 10 parts of morinda root; preferably, it is prepared as a freeze-dried powder preparation. The traditional Chinese medicine compound preparation of this invention can significantly improve hair loss in naturally aging female mice, promote hair growth, improve the weight of hair on the back of mice and the number of hair follicles on the back skin, and has a good anti-hair loss effect, which is superior to the control drug. At the same time, it provides a drug option for other types of hair loss besides androgenetic alopecia in women.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to the application of a traditional Chinese medicine compound in the preparation of a drug for treating or improving hair loss. Background Technology

[0002] Existing research indicates that many women experience hair loss. The prevalence of hair loss in women increases with age, and clinically, it is most common after middle age or postpartum, often associated with poor sleep, lack of sleep, stress, or excessive pressure. The chronic nature and difficulty in treating hair loss not only affect a patient's appearance but also negatively impact their mental health and quality of life.

[0003] Currently, common clinical medications for treating female pattern hair loss include minoxidil and finasteride. While these medications can promote hair growth to some extent, they suffer from long treatment cycles, slow onset of action, and ineffectiveness in some individuals. Finasteride, as an androgen inhibitor, has significant impacts on women's health and is generally not recommended for their use. Topical minoxidil also presents challenges such as increased hair loss in the initial stages and insufficient short-term efficacy.

[0004] Furthermore, current first-line medications for treating hair loss are mostly indicated for androgenetic alopecia. The causes of hair loss are complex. In middle-aged and elderly women, hair loss is often related to a variety of complex factors, including hair follicle aging, hormone metabolism, and environmental conditions. With age, various types of age-related hair loss may occur, including alopecia areata, diffuse female pattern hair loss, and telogen effluvium. However, medications specifically targeting these types of hair loss remain relatively scarce.

[0005] Therefore, developing a traditional Chinese medicine preparation with a short treatment cycle, significant efficacy, and superior performance compared to existing chemical drugs in treating other types of hair loss besides androgenetic alopecia in women has important scientific significance and clinical application potential. Summary of the Invention

[0006] The purpose of this invention is to provide an application of a traditional Chinese medicine composition in the preparation of a medicament for treating or improving hair loss related to natural aging in women, so as to solve the above-mentioned problems.

[0007] To achieve the above objectives, the technical solution adopted by the present invention is as follows:

[0008] The application of a traditional Chinese medicine compound in the preparation of a drug for treating or improving hair loss, wherein the traditional Chinese medicine compound is prepared from raw materials in the following weight ratio:

[0009] White peony root 10-15 parts, Bupleurum root 6-10 parts, Rehmannia root 10-15 parts, stir-fried yam 15-20 parts, Cuscuta seed 12 parts, Angelica root 10 parts, Poria cocos 10 parts, Ligustrum lucidum 12 parts, Salvia miltiorrhiza 10-15 parts, Cornus officinalis 10-12 parts, Morinda officinalis 10 parts.

[0010] The hair loss mentioned refers to hair loss related to natural aging in women.

[0011] The specific Chinese herbal ingredients involved in the compound formula of this invention are as follows:

[0012] White peony root is the dried root of Paeonialactiflora Pal., a plant in the Ranunculaceae family.

[0013] Bupleurum is the dried root of Bupleurum chinense DC. or Bupleurum corzonerifolium Willd., both belonging to the Apiaceae family.

[0014] Rehmannia glutinosa (Shu Di) is the dried tuberous root of Rehmannia glutinosa Libosch., a plant of the Scrophulariaceae family, which is prepared by stewing with wine or steaming.

[0015] Yam is the dried rhizome of Dioscorea opposita Thunb., a plant belonging to the Dioscoreaceae family.

[0016] Cuscuta seeds are the dried, mature seeds of Cuscuta australis R.Br. or Cuscuta chinensis Lam., plants belonging to the Convolvulaceae family.

[0017] Angelica sinensis is the dried root of Angelica sinensis (Oliv.) Diels, a plant belonging to the Apiaceae family.

[0018] Poria cocos is the dried sclerotium of the fungus Poriacocos (Schw.) Wolf, belonging to the Polyporaceae family.

[0019] Privet fruit is the dried, ripe fruit of Ligustrum lucidum Ait., a plant in the Oleaceae family.

[0020] Danshen is the dried root and rhizome of Salvia miltiorrhiza Bge., a plant belonging to the Lamiaceae family.

[0021] Cornus officinalis, also known as Cornus officinalis, is the dried, ripe pulp of the Cornus officinalis plant (Cornus officinalis Sieb. et Zucc.).

[0022] Morinda officinalis is the dried root of Morinda officinalis How, a plant in the Rubiaceae family.

[0023] According to traditional Chinese medicine theory, among the above components, Cuscuta chinensis nourishes the kidneys and liver, while Rehmannia glutinosa nourishes yin and kidneys. When used together, they nourish the kidneys and replenish essence, nourishing the Chong and Ren meridians, and serve as the principal herbs. Angelica sinensis and Paeonia lactiflora nourish blood, soften the liver, and regulate menstruation. Bupleurum chinense can soothe the liver and relieve depression, as well as regulate blood. Poria cocos is sweet and bland in nature, and when combined with Dioscorea opposita, it strengthens the spleen and stomach. Ligustrum lucidum nourishes the liver and kidneys, and together they strengthen the innate spleen and stomach and nourish the acquired liver and kidneys, serving as the assistant herbs. Cornus officinalis and Morinda officinalis tonify kidney yang and consolidate essence, serving as adjuvant herbs. Salvia miltiorrhiza invigorates blood, nourishes blood, removes blood stasis, and regulates menstruation, serving as the guiding herb.

[0024] The pharmacological effects of the formulation in this invention can be explained from the perspective of traditional Chinese medicine as follows:

[0025] Traditional Chinese medicine (TCM) believes that hair loss associated with aging is often related to multiple factors, including kidney essence deficiency, insufficient qi and blood, and blood stasis. The TCM compound of this invention can improve hair loss by synergistically regulating the body's internal environment through multiple targets and pathways. For women, treating female hair loss requires a multi-pronged approach, addressing issues such as nourishing the liver, tonifying the kidneys, replenishing blood, and relieving depression. The TCM composition described in this invention has the effects of tonifying the kidneys and strengthening essence, removing blood stasis and relieving depression, promoting blood circulation and nourishing blood, and strengthening the spleen and stomach, demonstrating significant efficacy in treating female hair loss.

[0026] As a preferred technical solution, the traditional Chinese medicine compound is prepared from the following raw materials in the indicated weight ratios: 10 parts white peony root, 6 parts bupleurum root, 10 parts prepared rehmannia root, 15 parts stir-fried yam, 12 parts dodder seed, 10 parts angelica root, 10 parts poria cocos, 12 parts privet fruit, 10 parts salvia miltiorrhiza root, 10 parts cornus fruit, and 10 parts morinda root.

[0027] As a preferred technical solution, the traditional Chinese medicine compound is prepared from the following raw materials in the indicated weight ratios: 15 parts white peony root, 10 parts bupleurum root, 15 parts prepared rehmannia root, 20 parts stir-fried yam, 12 parts dodder seed, 10 parts angelica root, 10 parts poria cocos, 12 parts privet fruit, 15 parts salvia miltiorrhiza root, 12 parts cornus fruit, and 10 parts morinda root.

[0028] As a preferred technical solution, the drug is an oral preparation or a lyophilized powder.

[0029] As a further preferred technical solution, the preparation method of the drug is to extract and concentrate the raw materials to obtain a concentrated solution; then add pharmaceutically acceptable excipients to prepare an oral preparation, or directly freeze-dry to prepare a freeze-dried powder.

[0030] As a further preferred technical solution, the method for preparing the concentrate includes the following steps:

[0031] (1) Weighing and soaking: Weigh the raw materials according to the proportion, put them into 10 times the volume of pure water, soak for 30 minutes, boil gently for 1 hour, and filter to obtain extract and residue.

[0032] (2) Decoction: Add 6 to 10 times the volume of purified water to the obtained filter residue, simmer at 100°C for 1 hour, filter to obtain the extract; repeat this step, and decoct the filter residue at least twice.

[0033] (3) Concentration: Combine the extracts from each of the above steps and concentrate them under vacuum at 50-60°C until each milliliter contains 0.7-1.0g of medicinal slices, or concentrate them to 10%-20% of the total mass of the raw materials.

[0034] It should be noted that, based on common sense that can be understood by those skilled in the art, the efficacy of traditional Chinese medicine compound prescriptions (the main active ingredients and their proportions) is mainly determined by the raw material formula and their proportions. Therefore, Examples 1 and 2 described below are only illustrative examples. Using the preparation method of the present invention, within the above parameter range, it is possible to obtain a concentrated solution with almost the same effective ingredients and concentration.

[0035] As a further preferred technical solution, the freeze-drying method is as follows:

[0036] Pre-freezing: The concentrate is pre-frozen at -80℃ for 12 to 24 hours;

[0037] Sublimation drying: Vacuum at -80℃ for 48-72 hours; then dry at 30℃ for 24-48 hours. After freeze-drying, crush, sieve, and seal the freeze-dried material to obtain freeze-dried Chinese medicine powder.

[0038] This invention is a new application based on the applicant's previous application CN121081564A. The formulation and preparation method can be found in CN121081564A. As described in CN121081564A, this formulation was designed for the treatment of female ovarian dysfunction. The inventors used various models of female ovarian dysfunction to verify the formulation's efficacy in protecting the ovaries. During the experiments, the inventors unexpectedly discovered that this formulation significantly improved hair loss in naturally aging female mice, but did not have this effect on hair loss induced by other chemotherapy models. Based on this unexpected discovery, the inventors conducted extensive experiments to verify that it has stable efficacy in treating female hair loss related to natural aging, and its efficacy is significantly superior to current first-line drugs for treating female hair loss in clinical practice.

[0039] The "natural aging" of this invention refers to a series of bodily functional changes that occur in healthy women with age. The "natural aging-related hair loss" is described in the paper "Prevalence of female pattern hair loss in postmenopausal women: a cross-sectional study" by Chaikittisilpa and Sukanya: it is female pattern hair loss that occurs with age in healthy postmenopausal women, with a high prevalence in postmenopausal women. It is characterized by non-scarring diffuse hair loss due to progressive atrophy of hair follicles and subsequent reduction in hair quantity. Commonly affected areas are the central, frontal, and parietal regions. The typical pattern is centrifugal expansion of the central scalp while the hairline remains intact. Although female pattern hair loss in postmenopausal women and androgenetic alopecia in men share a common hair follicle degeneration pathway, the role of androgens in female pattern hair loss is unclear, and the etiology of female pattern hair loss remains undetermined.

[0040] The main advantages of this invention include:

[0041] (a) Compared with existing drugs such as minoxidil, finasteride and compound preparations of the two in different proportions, as well as other drugs with other indications for androgenetic alopecia, the drug provided by the present invention provides an alternative drug for women to treat other types of hair loss besides androgenetic alopecia; it has significant efficacy, especially in treating women’s age-related hair loss.

[0042] (b) As a traditional Chinese medicine composition, the selected drugs in this invention have been documented in past clinical cases, the side effects are relatively controllable, the safety is higher, and it can be used for a long time.

[0043] (c) The drug in this invention has a long-term effect of maintaining efficacy after discontinuation, which improves the disadvantage of relapse after discontinuation of existing drugs.

[0044] Specifically, the inventors conducted numerous comparative experiments, with sufficient biological replicates for each experimental group in each comparative experiment. Eight-week-old female C57BL / 6J mice were selected as the blank control group. Several ten-month-old naturally aging female mice were randomly divided into a natural aging model group, a minoxidil group, and a traditional Chinese medicine example group. The efficacy of the traditional Chinese medicine composition in this invention was compared with that of minoxidil, an existing drug for treating female hair loss. After 42 days of continuous administration, changes in hair regeneration, hair density, and hair follicle number on the backs of the female mice in each group were observed. The results showed:

[0045] The hair regeneration speed and regeneration status of the herbal compound group of this invention are significantly better than those of the minoxidil group; the hair density, hair weight and number of hair follicles of the herbal compound group of this invention are significantly higher than those of the minoxidil group.

[0046] Compared with the prior art, the advantages of the present invention are as follows:

[0047] (1) This invention uses the synergistic effect of traditional Chinese medicine compound to improve hair loss, especially female aging-related hair loss, from multiple aspects such as nourishing the liver and kidneys, nourishing blood and promoting blood circulation, and improving hair follicle microcirculation;

[0048] (2) This invention uses freeze-drying process to retain the active ingredients of traditional Chinese medicine to the greatest extent, thereby improving the stability and bioavailability of the preparation;

[0049] (3) Animal experiments have shown that the freeze-dried compound Chinese medicine powder of the present invention is significantly more effective than minoxidil in promoting hair growth and increasing the number of hair follicles in aging female mice;

[0050] (4) The present invention has high safety, is suitable for long-term use, and has good industrialization prospects;

[0051] (5) The present invention can maintain the efficacy for a long time after the drug is discontinued. Attached Figure Description

[0052] Figure 1 Hair growth in each group of experimental mice before drug treatment;

[0053] Figure 2 Comparison of hair growth in different groups of experimental mice after administration of different drugs;

[0054] Figure 3 A continuous comparison of hair growth in each group of experimental mice after administration of the control drug and the drug of the present invention;

[0055] Figure 4 An example of a method for measuring the average gray value of hair on the back of a mouse;

[0056] Figure 5 The quantitative results of hair grayscale values ​​of experimental mice in each group after administration of the control drug and the drug of the present invention, respectively;

[0057] Figure 6 The results show the hair weight of each group of experimental mice after administration of the control drug and the drug of the present invention, respectively.

[0058] Figure 7 The method for counting hair follicles after longitudinal sectioning of full-thickness skin pathological sections of mice in each group of experiments is shown. The left image shows the counted length of the back skin, which is 6604.51 μm; the red arrow in the right image points to the mouse hair follicles.

[0059] Figure 8 The results show the number of hair follicles in each group of experimental mice after administration of the control drug and the drug of the present invention, respectively.

[0060] Figure 9This is a comparison of hair growth in mice from the natural aging model group and mice treated with the drug of this invention after discontinuation of drug administration. Detailed Implementation

[0061] To explain the technical content, objectives, and effects of the present invention in detail, the following specific embodiments are provided to further illustrate the content of the present invention. However, the content of the present invention is far more than the following examples.

[0062] Unless otherwise specified, the experimental methods described in the following examples are conventional methods; unless otherwise specified, the reagents and materials are commercially available.

[0063] Example 1

[0064] A compound freeze-dried powder of traditional Chinese medicine, the formula of which is: 10g of white peony root, 6g of bupleurum root, 10g of prepared rehmannia root, 15g of stir-fried yam, 12g of dodder seed, 10g of angelica root, 10g of poria cocos, 12g of privet fruit, 10g of salvia root, 10g of cornus fruit, and 10g of morinda root.

[0065] The method for preparing the above-mentioned compound into a freeze-dried traditional Chinese medicine powder includes the following steps:

[0066] (1) Processing of medicinal materials: Weigh each Chinese medicinal material according to the above weight proportions, wash and remove impurities, and dry for later use;

[0067] (2) Decoction extraction: Mix the medicinal materials and add water with a total weight of 8 times, soak for 30 minutes, and decoct over low heat; after decoction, filter to separate the dregs and extract, add water to the dregs and decoct again, repeat this at least 3 times, each time for 1.5 hours, and finally combine the extracts obtained each time.

[0068] (3) Concentration of medicinal liquid: The combined extracts are concentrated under reduced pressure at 55°C to 15% of the total mass of the original medicinal materials to obtain the concentrated liquid;

[0069] (4) Pre-freezing: Pre-freeze the concentrate at −80℃ for 18 hours;

[0070] (5) Freeze-drying and pulverizing: Place the pre-frozen material in a freeze dryer and freeze-dry at -80℃ for 60 hours and at 30℃ for 36 hours; pulverize and sieve the freeze-dried material, seal and package it to obtain the finished freeze-dried Chinese medicine powder.

[0071] Example 2

[0072] A compound freeze-dried powder of traditional Chinese medicine, the formula of which is: 15g of white peony root, 10g of bupleurum root, 15g of prepared rehmannia root, 20g of stir-fried yam, 12g of dodder seed, 10g of angelica root, 10g of poria cocos, 12g of privet fruit, 15g of salvia miltiorrhiza root, 12g of cornus fruit, and 10g of morinda root.

[0073] The freeze-dried powder of traditional Chinese medicine was prepared by the same method as in Example 1.

[0074] Effect test examples

[0075] 1.1 Experimental animals

[0076] 8-week-old, SPF-grade C57BL / 6J mice, female, weighing 20-22 g, purchased from Sichuan Vital River Laboratory Animal Technology Co., Ltd., production license number: SCXK(Sichuan)2023-0040, use license number: SYXK(Sichuan)2023-0263;

[0077] 10-month-old, SPF-grade C57BL / 6J mice, female, weighing 25-30 g, purchased from Sichuan Vital River Laboratory Animal Technology Co., Ltd., production license number: SCXK(Sichuan)2023-0040, use license number: SYXK(Sichuan)2023-0263;

[0078] All were specially raised by the Analysis and Testing Center of West China School of Public Health, Sichuan University.

[0079] 1.2 Experimental materials

[0080] The experimental materials are shown in Table 1;

[0081] Table 1 Experimental materials and sources

[0082] <​​​​​​​​​​​​

[0086] Table 2. Administration methods for different groups

[0087]

[0088] Based on the physiological changes of C57BL / 6J mice, hair loss is usually relatively stable between 10 and 12 months of age, and the degree of hair loss will continue to worsen with age.

[0089] In the experiment, 8-week-old young female mice in the blank control group were administered purified water by gavage once a day for 42 days; the natural aging model group was administered purified water by gavage once a day for 42 days; the 2% minoxidil group was administered 2 ml of the drug (containing 40 mg of minoxidil) evenly to the hairless area on the back of the mice, once a day for 42 days, according to the maximum daily human dose limit specified in the instructions. The application was started from the center of the affected area and massaged by hand for 3-5 minutes. This dose was applicable regardless of the size of the affected area. The mice were also administered purified water by gavage daily, following the principle of the only variable; the 5% minoxidil group was administered 2 ml of the drug (containing 100 mg of minoxidil) to the hairless area on the back of the mice, once a day for 42 days, according to the maximum daily human dose limit specified in the instructions. The application was started from the center of the affected area and massaged by hand for 3-5 minutes. This dose was applicable regardless of the size of the affected area. The mice were also administered purified water by gavage daily, following the principle of the only variable.

[0090] In the Traditional Chinese Medicine Example 1 and Example 2 groups, the daily dosages for mice were 9.46 g / kg and 11.66 g / kg, respectively, based on mouse body weight, which are equivalent to the clinically equivalent adult doses. The corresponding dose of lyophilized powder was dissolved in 0.5 ml of purified water and administered by gavage daily for 42 days.

[0091] After the administration of the drug, no further intervention was given to the mice. They were simply fed under suitable conditions, and their hair growth was recorded again two months after the drug was discontinued.

[0092] 1.4 Experimental Results

[0093] 1.4.1 Hair growth

[0094] The hair growth of each group of mice was observed daily, and starting from the first day after hair loss, the hair growth on the backs of the mice was recorded weekly. The hair growth changes of each group of mice are as follows: Figures 1 to 3 As shown. The traditional Chinese medicine composition of the present invention is more effective than two commonly available concentrations of minoxidil in improving hair loss in naturally aging mice, and its efficacy is more stable, making up for the shortcomings of minoxidil in treating hair loss types other than androgenetic alopecia.

[0095] 1.4.2 Quantitative analysis of hair growth using grayscale values

[0096] The average gray value was used to quantitatively analyze mouse hair density, referring to the method in Majid Manzoor's paper "Isoquercitrin promotes hair growth through induction of autophagy and angiogenesis by targeting AMPK and IGF-1R". The average gray value is calculated as the sum of the gray values ​​of all pixels in the selected area / the number of pixels in the selected area.

[0097] Images of mouse back skin and fur were converted into 8-bit grayscale images using ImageJ software. The difference in grayscale between black fur (low grayscale) and bare / grayish-white skin (high grayscale) was used to represent hair coverage. Comparable quantitative indicators of hair growth were obtained by integrating the grayscale values. In ImageJ, grayscale values ​​were divided into 255 levels, with pure black having a grayscale value of 0 and pure white having a grayscale value of 255. By statistically analyzing the average grayscale value of the mouse back region, hair growth could be quantified. The lighter the color of the mouse fur and the sparser the fur, the higher the average grayscale value. Figure 4 As shown, Figure 4 The average grayscale value of the left image is 121.383, and the average grayscale value of the right image is 31.786. Experimental Results Figure 5 And as shown in Table 3 below.

[0098] Table 3. Statistical results of average gray values ​​of different experimental groups

[0099]

[0100] Note: Data in each group were compared using one-way ANOVA. ns indicates no significant difference compared to the model group, * indicates p < 0.05 compared to the model group, ** indicates p < 0.01 compared to the model group, *** indicates p < 0.001 compared to the model group, and **** indicates p < 0.0001 compared to the model group.

[0101] The results showed that the natural aging model group exhibited significant hair loss compared to the blank control group, making it an effective mouse model of age-related hair loss. The 2% minoxidil group, the traditional Chinese medicine example 1 group, and the traditional Chinese medicine example 2 group all significantly improved the hair condition of the mice, while the 5% minoxidil group showed poor results. Among them, the traditional Chinese medicine example 1 group and the traditional Chinese medicine example 2 group showed significantly better results than the two concentrations of minoxidil.

[0102] 1.4.3 Hair weight evaluation

[0103] After the 42-day drug administration period, the experimental mice were euthanized, and the hair that grew back in the shaved areas on the backs of the mice was collected and weighed. The experimental results are as follows: Figure 6 As shown in Table 4 below.

[0104] Table 4. Statistical results of hair weight in different experimental groups

[0105]

[0106] Note: Hair weights in Table 4 are mean ± standard deviation. Data in each group were compared using one-way ANOVA. ns indicates no significant difference compared to the model group, * indicates p < 0.05, ** indicates p < 0.01, *** indicates p < 0.001, and **** indicates p < 0.0001.

[0107] The results showed that the natural aging model group had significant hair loss compared to the blank control group, making it an effective mouse hair loss model related to aging. The 2% minoxidil group, the traditional Chinese medicine example 1 group, and the traditional Chinese medicine example 2 group all significantly improved the hair condition of the mice, while the 5% minoxidil group was not effective. Among them, the traditional Chinese medicine example 1 group and the traditional Chinese medicine example 2 group were significantly better than the two concentrations of minoxidil.

[0108] It is evident that the drug described in this invention is more effective in improving hair loss due to aging in female mice.

[0109] 1.4.4 Evaluation of hair follicle quantity

[0110] Skin samples were taken from the hair-removal area parallel to the spine. The skin was trimmed into 1cm wide strips, fixed in 10% neutral formalin solution for 24-36 hours, dehydrated with graded alcohol, embedded in paraffin, trimmed, and longitudinally sectioned in full thickness. After H&E staining, the samples were observed and the number of hair follicles was counted under a light microscope. The counting method is as follows: Figure 7 As shown. The experimental results are as follows. Figure 8 And as shown in Table 5 below.

[0111] Table 5. Statistical results of hair follicle count in different experimental groups

[0112]

[0113] Note: The average number of hair follicles per millimeter in Table 5 is the mean ± standard deviation. The average number of hair follicles = number of hair follicles in the counted length of skin / counted skin length. Data in each group were compared using one-way ANOVA. ns indicates no significant difference compared to the model group, * indicates p < 0.05 compared to the model group, ** indicates p < 0.01 compared to the model group, *** indicates p < 0.001 compared to the model group, and **** indicates p < 0.0001 compared to the model group.

[0114] Furthermore, as disclosed in CN121081564A, a previous application filed by the applicant, the traditional Chinese medicine composition of this invention has the effect of increasing estradiol levels. Although prior art has reported a link between hair loss in middle-aged and elderly women and decreased estrogen levels, existing research evidence also indicates that both increases and decreases in estrogen can induce hair loss, and any significant change in estrogen levels (either a rise leading to synchronized withdrawal or an absolute decrease) can trigger female hair loss. As described in Madison J. Anzelc's paper "Considerations for cutaneous physiologic changes of pregnancy that fail to resolve postpartum," elevated placental estrogen levels during pregnancy prolong the hair growth phase. After delivery, the withdrawal of these growth hormones causes all hairs that have exceeded the growth phase to simultaneously enter the regression phase, resulting in increased shedding of telogen effluvium in the postpartum months. This illustrates that elevated estrogen levels can also lead to female hair loss, and the effect of drugs that increase estrogen levels on hair loss is unpredictable. This also highlights the limitations of treating hair loss by increasing estrogen levels: the "protective effect" of estrogen is temporary, and its fluctuations themselves constitute a risk of hair loss. Once medication is discontinued, patients may face more severe hair loss. Therefore, there is no necessary connection between drug-induced increases or decreases in estrogen levels and the ability to treat hair loss.

[0115] Furthermore, long-term oral or injectable estrogen can cause obvious side effects in women. For example, authoritative literature (Breast cancer and hormone-replacement therapy in the Million Women Study) reports that patients using estrogen preparations long-term have an increased incidence of breast cancer. Therefore, treating hair loss by supplementing with estrogen is not a safe or effective solution.

[0116] Furthermore, the mechanism by which the traditional Chinese medicine compound of this invention improves or treats hair loss is complex and not necessarily related to an increase in estrogen levels after medication. The active ingredients in this formula are numerous and their pharmacological effects are complex, resulting in typical unpredictability in its clinical efficacy. Therefore, the prior art cannot provide technical inspiration for this invention.

[0117] It should also be noted that the traditional Chinese medicine compound in this application consists of multiple drugs that have been used clinically for many years, and its safety is guaranteed. Furthermore, as... Figure 9 As shown, this formulation exhibits significant improvement in the persistence of efficacy after drug withdrawal. Continuous observation after drug withdrawal revealed that female aging mice treated with this formulation maintained good coat condition two months after drug withdrawal.

[0118] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. Use of a traditional Chinese medicine compound in the preparation of a medicament for treating or improving alopecia, characterized in that, The traditional Chinese medicine compound is prepared from the following raw materials in the indicated weight ratios: White peony root 10 parts, Bupleurum root 6 parts, Rehmannia root 10 parts, stir-fried yam 15 parts, Cuscuta seed 12 parts, Angelica root 10 parts, Poria cocos 10 parts, Ligustrum lucidum 12 parts, Salvia miltiorrhiza 10 parts, Cornus officinalis 10 parts, Morinda officinalis 10 parts; or: White peony root 15 parts, Bupleurum root 10 parts, Rehmannia root 15 parts, stir-fried yam 20 parts, Cuscuta seed 12 parts, Angelica root 10 parts, Poria cocos 10 parts, Ligustrum lucidum fruit 12 parts, Salvia miltiorrhiza root 15 parts, Cornus officinalis fruit 12 parts, Morinda officinalis root 10 parts; The hair loss mentioned refers to hair loss related to natural aging in women.

2. Use according to claim 1, characterized in that, The drug is an oral preparation.

3. The application according to claim 1, characterized in that, The drug is a lyophilized powder.

4. Use according to claim 2 or 3, characterised in that, The preparation method of the drug is as follows: the raw materials are extracted and concentrated to obtain a concentrated liquid; then pharmaceutically acceptable excipients are added to prepare an oral preparation, or the drug is directly freeze-dried to prepare a freeze-dried powder.

5. The use according to claim 4, characterized in that, The method for preparing the concentrate includes the following steps: (1) Weighing and soaking: Weigh the raw materials according to the proportion, put them into 10 times the volume of pure water, soak for 30 minutes, boil gently for 1 hour, and filter to obtain extract and residue. (2) Decoction: Add 6 to 10 times the volume of purified water to the obtained filter residue, simmer at 100°C for 1 hour, and filter to obtain the extract; Repeat this step, boiling the filtered residue at least twice; (3) Concentration: Combine the extracts from each of the above steps and concentrate them under vacuum at 50-60°C to a concentration of 0.7-1.0g of medicinal slices per milliliter, or to a concentration of 10%-20% of the total mass of the raw materials.

6. The use according to claim 4, characterized in that, The freeze-drying method is as follows: Pre-freezing: The concentrate is pre-frozen at -80℃ for 12 to 24 hours; Sublimation drying: Vacuum at -80℃ for 48-72 hours; then dry at 30℃ for 24-48 hours. After freeze-drying, crush, sieve, and seal the freeze-dried material to obtain freeze-dried Chinese medicine powder.

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