Use of a traditional Chinese medicine composition in the preparation of a drug for preventing and / or treating menopausal syndrome

Abstract

The present application relates to the technical field of traditional Chinese medicine, and particularly relates to application of a traditional Chinese medicine composition in preparation of a medicine for preventing and / or treating menopausal syndrome, wherein the traditional Chinese medicine composition is prepared from turtle shell, radix falcaliae, rhizoma discontinu, medlar, rhizoma atractylodis macrocephalae and poria cocos.The present application can increase the content level of estradiol (E2) and progesterone (P) in serum of ovariectomized female rats, and obviously reduce the content of follicle stimulating hormone (FSH) and luteinizing hormone (LH); increase the sleeping number of ovariectomized female mice induced by sodium pentobarbital, reduce the sleeping latency, and prolong the sleeping time; obviously increase the activity of superoxide dismutase (SOD) and glutathione peroxidase (GSH-PX) in serum of ovariectomized female mice, and reduce the content of malondialdehyde (MDA), which indicates that the traditional Chinese medicine composition has a good treatment effect on menopausal syndrome.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and to a new use of a traditional Chinese medicine composition, specifically to the application of a traditional Chinese medicine composition in the preparation of drugs for the prevention and / or treatment of menopausal syndrome. Background Technology

[0002] Climacteric syndrome is a series of clinical symptoms that occur in women during menopause due to physiological and psychological changes. Menopausal women experience decreased ovarian function and increased pituitary function, leading to excessive secretion of gonadotropins and causing autonomic nervous system dysfunction. This results in a range of symptoms of varying degrees, such as menstrual changes, hot flashes, palpitations, insomnia, fatigue, depression, anxiety, mood swings, irritability, and difficulty concentrating.

[0003] Most women experience a slow decline in ovarian function, allowing their bodies to adapt naturally and compensate adequately, or they may only experience mild symptoms. A small number of women experience more pronounced symptoms because their bodies cannot adapt quickly, but generally do not require specific treatment. In a very small number of cases, the symptoms are severe, even affecting their daily lives and work, requiring medication. Menopausal syndrome falls under the category of "pre- and post-menopausal symptoms" in Traditional Chinese Medicine (TCM). TCM believes that menopausal syndrome is caused by insufficient kidney qi and declining Tian Gui (menstrual blood), leading to an imbalance of Yin and Yang. Therefore, treatment primarily focuses on tonifying kidney qi and regulating Yin and Yang.

[0004] However, current treatments are not very effective, and long-term use of estrogen may increase the risk of endometrial cancer and breast cancer, especially for women with a family history or past medical history, who need to be strictly evaluated. Therefore, providing traditional Chinese medicine compositions and their application in the preparation of drugs for treating menopausal syndrome is of great practical significance. Summary of the Invention

[0005] In view of this, the present invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for treating menopausal syndrome. This traditional Chinese medicine composition has a good therapeutic effect on menopausal syndrome.

[0006] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0007] This invention provides the use of a traditional Chinese medicine composition in the preparation of a medicament for the prevention and / or treatment of menopausal syndrome, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

[0008]

[0009] In some specific embodiments of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0010]

[0011] In some specific embodiments of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0012]

[0013] In some specific embodiments of the present invention, the traditional Chinese medicine composition comprises the following components in parts by weight:

[0014]

[0015] In some specific embodiments of the present invention, the preparation method of the traditional Chinese medicine composition includes the following steps:

[0016] Step 1: Add water to the prescribed amount of Polygonum multiflorum, Dipsacus asper, and Atractylodes macrocephala and decoct. Filter the solution, combine the filtrates, concentrate them into an extract, cool to room temperature, add ethanol to the extract, let it stand, take the supernatant, recover the ethanol, concentrate it into a second concentration to obtain the first extract, filter it for later use.

[0017] Step 2: Add water to the prescribed amounts of turtle shell, wolfberry, and poria cocos and decoct. Filter the decoction, combine the filtrates, and concentrate them in a third stage to obtain the second extract. Filter the extract and set it aside.

[0018] Step 3: Combine the first extract and the second extract and mix well.

[0019] In some specific embodiments of the present invention, the first concentration in step 1 is: concentrating at 50-80°C to a relative density of 1.10-1.15; and / or

[0020] The amount of water added in step 1 is 8 times the original amount of medicine; and / or

[0021] The decoction process described in step 1 is performed three times, each time for one hour; and / or

[0022] The addition of ethanol in step 1 is to achieve an alcohol content of 60% (v / v); and / or

[0023] The settling time mentioned in step 1 is at least 12 hours; and / or

[0024] The second concentration in step 1 is: concentrating at 50–80°C to a relative density of 1.20–1.23; and / or

[0025] The third concentration mentioned in step 2 is: concentrating at 50–80°C to a relative density of 1.20–1.23; and / or

[0026] The amount of water added in step 2 is 8 times the original amount of medicine; and / or

[0027] The simmering process described in step 1 is repeated 3 times, with each simmering lasting 1 hour.

[0028] In some specific embodiments of the present invention, the medicament includes any of the following and pharmaceutically acceptable excipients:

[0029] (I) The traditional Chinese medicine composition; or

[0030] (II) The traditional Chinese medicine composition prepared by the above method.

[0031] In some specific embodiments of the present invention, the excipients include steviol glycosides and / or dextrin;

[0032] Preferably, by weight, it includes:

[0033] 5 parts of steviol glycosides;

[0034] 40-70 parts of dextrin.

[0035] In some specific embodiments of the present invention, the dosage form of the drug includes one or more of oral dosage forms, injectable dosage forms, or topical dosage forms;

[0036] Preferably, the dosage form of the drug includes one or more of the following: decoction, granules, capsules, tablets, oral liquid, pills, tinctures, syrups, gels, sprays, or injections.

[0037] In some specific embodiments of the present invention, the method for preparing the drug includes the following steps:

[0038] The traditional Chinese medicine composition was prepared according to the described preparation method;

[0039] Add the amounts of steviol glycosides and / or dextrin specified in the formula, and granulate.

[0040] The composition provided by this invention can increase the levels of estradiol (E2) and progesterone (P) in the serum of castrated female rats, and significantly reduce the levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH); increase the number of sleepers in castrated female mice induced by sodium pentobarbital, reduce sleep latency, and prolong sleep time; significantly increase the activities of superoxide dismutase (SOD) and glutathione peroxidase (GSH-PX) in the serum of castrated female mice, and reduce the level of malondialdehyde (MDA), suggesting that this traditional Chinese medicine composition has a good therapeutic effect on menopausal syndrome. Detailed Implementation

[0041] This invention discloses the application of a traditional Chinese medicine composition in the preparation of drugs for the prevention and / or treatment of menopausal syndrome. Those skilled in the art can refer to the content of this document and appropriately modify the process parameters to achieve the desired result. It should be particularly noted that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included in this invention. The methods and applications of this invention have been described through preferred embodiments. Those skilled in the art can obviously make modifications or appropriate alterations and combinations to the methods and applications described herein without departing from the content, spirit, and scope of this invention to realize and apply the technology of this invention.

[0042] This invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for menopausal syndrome. The composition is prepared from turtle shell, Polygonum multiflorum, Dipsacus asper, Lycium barbarum, Atractylodes macrocephala, and Poria cocos. The term "used for" can refer to any method beneficial to improving the corresponding symptoms of the patient, including treatment or prevention.

[0043] The traditional Chinese medicine composition includes: 1-100 parts of turtle shell, 1-100 parts of Polygonum multiflorum, 1-100 parts of Dipsacus asper, 1-100 parts of Lycium barbarum, 1-100 parts of Atractylodes macrocephala, and 1-100 parts of Poria cocos.

[0044] Furthermore, the traditional Chinese medicine composition includes: 1-70 parts of turtle shell, 1-70 parts of Polygonum multiflorum, 1-70 parts of Dipsacus asper, 1-70 parts of Lycium barbarum, 1-70 parts of Atractylodes macrocephala, and 1-70 parts of Poria cocos.

[0045] Preferably, the traditional Chinese medicine composition includes: 10-50 parts of turtle shell, 10-50 parts of Polygonum multiflorum, 10-50 parts of Dipsacus asper, 10-50 parts of Lycium barbarum, 10-50 parts of Atractylodes macrocephala, and 10-50 parts of Poria cocos.

[0046] Most preferably, the traditional Chinese medicine composition includes: 10-50 parts of turtle shell, 10-50 parts of Polygonum multiflorum, 10-50 parts of Dipsacus asper, 10-50 parts of Lycium barbarum, 10-50 parts of Atractylodes macrocephala, and 10-50 parts of Poria cocos.

[0047] The above-mentioned composition can be made by directly grinding raw materials into powder and mixing, or it can be an extract or other form obtained by conventional means. The raw materials used can also be used by directly grinding them into powder, extracting them, or using other processed forms.

[0048] Specifically, the drug dosage forms for menopausal syndrome provided by the present invention include oral dosage forms, injectable dosage forms, or topical dosage forms.

[0049] The dosage form of the drug of the present invention is prepared by weighing the raw material in proportion, and then adding pharmaceutically acceptable excipients or additives, such as fillers, disintegrants, lubricants, suspending agents, binders, sweeteners, flavoring agents, preservatives, and matrices, in accordance with conventional pharmaceutical production methods, to produce a pharmaceutically acceptable conventional dosage form, including but not limited to decoctions, granules, capsules, tablets, oral liquids, pills, tinctures, syrups, suppositories, gels, sprays, and injections.

[0050] Furthermore, the preparation method of the aforementioned traditional Chinese medicine composition is as follows:

[0051] Step 1: Boil Polygonum multiflorum, Dipsacus asper, and Atractylodes macrocephala in water three times, filter, combine the filtrates, concentrate to extract, cool to room temperature, add ethanol to extract until the alcohol content reaches 60%, let stand, take the supernatant, recover the ethanol and concentrate to extract, filter for later use.

[0052] Step 2: Boil turtle shell, wolfberry and poria cocos in water three times, filter, combine the filtrates, concentrate to extract, filter and set aside;

[0053] Step 3: Combine the two extracts and mix well; add appropriate amounts of steviol glycosides and dextrin, granulate, and the product is obtained.

[0054] More preferably, the preparation method of the aforementioned traditional Chinese medicine composition is as follows:

[0055] Step 1: Boil Polygonum multiflorum, Dipsacus asper, and Atractylodes macrocephala in 8 times the amount of water three times, 1 hour each time. Filter the decoction, combine the filtrates, and concentrate them to an extract with a relative density of 1.10-1.15. Cool to room temperature, add ethanol to make the alcohol content reach 60%, let stand for more than 12 hours, take the supernatant, recover the ethanol and concentrate it to an extract with a relative density of 1.20-1.23. Filter and set aside.

[0056] Step 2: Add 8 times the amount of water to turtle shell, wolfberry, and poria cocos and decoct three times, one hour each time. Filter, combine the filtrates, concentrate to an extract with a relative density of 1.20-1.23, filter, and set aside.

[0057] Step 3: Combine the two extracts, mix well, add 5g of steviol glycosides and an appropriate amount of dextrin, granulate, and the product is ready.

[0058] This invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for treating menopausal syndrome. The composition is derived from turtle shell, Polygonum multiflorum, Dipsacus asper, Lycium barbarum, Atractylodes macrocephala, and Poria cocos. The composition significantly increases the levels of estradiol (E2) and progesterone (P) in the serum of castrated female rats, and significantly reduces the levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH); it increases the number of sleepers in castrated female mice induced by sodium pentobarbital, reduces sleep latency, and prolongs sleep time; it significantly increases the activities of superoxide dismutase (SOD) and glutathione peroxidase (GSH-PX) in the serum of castrated female mice, and reduces malondialdehyde (MDA) levels, demonstrating a good therapeutic effect on menopausal syndrome.

[0059] The raw materials and reagents used in the application of the traditional Chinese medicine composition provided by this invention in the preparation of drugs for the prevention and / or treatment of menopausal syndrome are all commercially available.

[0060] To enable those skilled in the art to more clearly understand the technical solution of this application, the technical solution of this application will be described in detail below with reference to specific embodiments. Unless otherwise specified, the following experiments were conducted under conventional conditions or conditions recommended by the manufacturer. The raw materials or excipients used, as well as the reagents or instruments whose manufacturers are not specified, are all commercially available conventional products. Experimental methods without specified detailed conditions were conducted according to conventional testing methods or the supplier's recommended operating instructions.

[0061] It should be noted that the following detailed descriptions are illustrative and intended to provide further explanation of this application. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application pertains. The following embodiments are merely for further illustrating the technical solutions of this application and are not intended to limit the scope of protection of this application.

[0062] Example 1: Preparation of the Traditional Chinese Medicine Composition

[0063] Take 357g of Polygoni Multiflori Radix, 357g of Teucrium Chuanxiong (note: corrected to standard pharmaceutical name: Dipsaci Radix), and 357g of Atractylodis Macrocephalae Rhizoma, add 8 times the amount of water to decoct three times, 1 hour each time, filter, combine the filtrates, concentrate (at 80°C) to an extract with a relative density of 1.10 to 1.15 (at 60°C), cool to room temperature (20°C ± 5°C), add ethanol to make the alcohol content reach 60%, let stand for 12 hours, take the supernatant, recover ethanol and concentrate (at 70°C) to an extract with a relative density of 1.20 to 1.23 (at 60°C), filter, and set aside; take 357g of Trionycis Carapax, 357g of Lycii Fructus, and 357g of Poria, add 8 times the amount of water to decoct three times, 1 hour each time, filter, combine the filtrates, concentrate (at 80°C) to an extract with a relative density of 1.20 to 1.23 (at 60°C), filter, and set aside. Combine the two groups of extracts described above, mix evenly, add 5g of steviol glycosides and 500g of dextrin, granulate, to obtain the product.

[0064] Experimental Example 2 Effects on the model of menopausal syndrome in female ovariectomized rats

[0065] 1. Experimental materials

[0066] Animals: 70 SPF-grade female SD rats, weighing 190-210g. Purchased from Zhejiang Vital River Laboratory Animal Technology Co., Ltd., License No.: SCXK (Zhejiang) 2024-0001.

[0067] Drugs: Diethylstilbestrol, traditional Chinese medicine composition.

[0068] Kits: Radioimmunoassay kit for estradiol (E2), radioimmunoassay kit for follicle-stimulating hormone (FSH), radioimmunoassay kit for luteinizing hormone (LH), and radioimmunoassay kit for progesterone (P) are provided by Shanghai Yuanye Bio-Technology Co., Ltd.

[0069] Instruments: Ultra-low temperature refrigerator, Haier, Model: DW-86L728; Electronic balance, Sartorius Scientific Instruments Co., Ltd., Model: BSA224S-CW; Microplate reader, Molecular Devices (USA), Model: Flexstation3.

[0070] 2. Dosage design

[0071] The human daily dosage of diethylstilbestrol is 6.60mg, the clinical dosage for an adult (calculated as 60kg) is 0.11mg / kg, and the equivalent dosage for rats is calculated to be 0.70mg / kg.

[0072] The human daily dosage of the traditional Chinese medicine composition is 20g, the clinical dosage for an adult (calculated as 60kg) is 0.33g / kg. The equivalent dosage for rats is calculated to be 2.10g / kg. This dosage is taken as the medium dosage, and designed according to the dosage ratio of 0.5:1:2, the low, medium and high dosages of the traditional Chinese medicine composition are 1.05, 2.10 and 4.20g / kg respectively.

[0073] 3. Experimental Methods

[0074] 3.1 Model Preparation

[0075] Seventy SD rats were randomly divided into cages of five and housed in a laboratory at 24°C and 40%–50% humidity, following a standard diet for acclimatization. The rats were randomly divided into three groups: a normal group (n=10), a sham-operated group (n=10), and a model group (n=50). Rats in the model group were anesthetized via intraperitoneal injection of 10% chloral hydrate solution. Abdominal hair was clipped, and the rats were fixed in a supine position on a surgical board. The surgical area was disinfected, and a 1.5cm incision was made along the lower abdominal midline to locate the bilateral uterus and ovaries. The uterine horns were ligated, the ovaries were removed, and an appropriate amount of gentamicin was instilled. The abdominal muscles and skin tissue were then sutured layer by layer. Vaginal smears were observed starting on the 5th postoperative day, once daily for 5 consecutive days. Irregular estrous changes in the rats were considered a successful model establishment. The sham-operated group underwent the same procedure as the model group, except that the ovaries were not removed.

[0076] 3.2 Animal grouping and administration

[0077] Rats that successfully established the model were randomly divided into 5 groups: the model group, the positive control drug diethylstilbestrol group, and the high, medium, and low dose groups of the traditional Chinese medicine composition, with 10 rats in each group. The blank control group, sham-operated group, and model group were given an equal volume of distilled water by gavage, while the low, medium, and high dose groups of the traditional Chinese medicine composition were given the corresponding drugs by gavage, once a day for 28 consecutive days.

[0078] After the last administration, the rats were fasted and deprived of water for 24 hours. They were then anesthetized with chloral hydrate and fixed. Blood was collected from the abdominal aorta, centrifuged at 3500 rpm for 10 min, and the serum was aliquoted and stored at -80℃.

[0079] 4. Experimental Results

[0080] The results showed that the serum E2 and P levels in the model group were significantly lower than those in the blank group and the sham-operated group (P < 0.01); the serum E2 and P levels in the positive control drug diethylstilbestrol group were significantly higher than those in the model group (P < 0.05); and the serum E2 level in the high-dose group of the traditional Chinese medicine composition was significantly higher (P < 0.05). The P level in the medium and high-dose groups of the traditional Chinese medicine composition was also significantly higher (P < 0.05).

[0081] Compared with the blank and sham-operated groups, the serum FSH and LH levels in the model group were significantly increased (P<0.01); compared with the model group, the serum FSH and LH levels in the positive control drug diethylstilbestrol group were significantly decreased (P<0.01); the serum FSH levels in the low, medium, and high dose groups of the traditional Chinese medicine composition were significantly decreased compared with the model group (P<0.01); compared with the model group, the serum LH levels in the medium and high dose groups of the traditional Chinese medicine composition were significantly decreased (P<0.01). The results are shown in Table 1.

[0082] Table 1 Effects of the traditional Chinese medicine composition on serum E2, FSH, LH and P hormone levels in ovariectomized female rats

[0083]

[0084]

[0085] Note: Compared with the blank control group, # P<0.05, ## P<0.01; compared with the model control group, *P<0.05, **P<0.01.

[0086] Experimental Example 3 Effects on the menopausal syndrome model of ovariectomized female mice

[0087] 1. Experimental materials

[0088] Animals: 70 SPF-grade female ICR mice, weighing 19-21g. Purchased from Suzhou Xishan Biotechnology Co., Ltd., License No.: SCXK (Su) 2022-0009.

[0089] Drugs: Diethylstilbestrol, sodium pentobarbital, traditional Chinese medicine composition.

[0090] Kits: Superoxide dismutase (SOD) kit, malondialdehyde (MDA) test kit, glutathione peroxidase (GSH-PX) test kit, provided by Nanjing Jiancheng Bioengineering Institute.

[0091] Instruments: Ultra-low temperature refrigerator, Haier, Model: DW-86L728; Electronic balance, Sartorius Scientific Instruments Co., Ltd., Model: BSA224S-CW; Microplate reader, Molecular Devices (USA), Model: Flexstation3.

[0092] 2. Dose design

[0093] The daily human dose of diethylstilbestrol is 6.60mg, the clinical dose for an adult (calculated as 60kg) is 0.11mg / kg, and the equivalent dose for mice is calculated to be 1.00mg / kg.

[0094] The daily human dose of the traditional Chinese medicine composition is 20g, the clinical dose for an adult (calculated as 60kg) is 0.33g / kg. The equivalent dose for mice is calculated to be 3.03g / kg. Taking this dose as the medium dose, and designing according to the dose ratio of 0.5:1:2, the low, medium and high doses of the traditional Chinese medicine composition are 1.52, 3.03 and 6.06g / kg respectively.

[0095] 3. Experimental method

[0096] Seventy ICR mice were randomly divided into cages of 10 each and housed in a laboratory at 24°C and 40%–50% humidity, following standard dietary adaptation procedures. The mice were randomly divided into three groups: a normal group (n=10), a sham-operated group (n=10), and a model group (n=50). Mice in the model group were anesthetized via intraperitoneal injection of chloral hydrate solution. Abdominal hair was clipped, and the mice were placed in a supine position on a surgical board. The surgical area was disinfected, and a 1cm incision was made along the lower abdominal midline to locate both uteruses and ovaries. The uterine horns were ligated, the ovaries were removed, and an appropriate amount of gentamicin was instilled. The abdominal muscles and skin tissue were then sutured layer by layer. Vaginal smears were observed starting on the 5th postoperative day, once daily for 5 consecutive days. Irregular estrous changes were considered a successful model establishment. The sham-operated group underwent the same procedure as the model group, except that the ovaries were not removed.

[0097] 3.2 Animal grouping and administration

[0098] Mice that successfully developed the model were randomly divided into 5 groups: the model group, the positive control drug diethylstilbestrol group, and the high, medium, and low dose groups of the traditional Chinese medicine composition, with 10 mice in each group. The blank control group, sham-operated group, and model group were given an equal volume of distilled water by gavage, while the low, medium, and high dose groups of the traditional Chinese medicine composition were given the corresponding drugs by gavage, once a day for 40 consecutive days.

[0099] One hour after the last administration to the mice, blood was collected from the inner canthus of the eye, centrifuged at 3500 rpm for 10 min, and the serum was aliquoted and stored at -80℃. The levels of SOD, MDA, and GSH-PX were then measured.

[0100] 3.2.1 Sedation-Hypnosis Experiment

[0101] Sedation-hypnosis experiments were conducted on animals 15 days after drug administration. One hour after drug administration, animals were intraperitoneally injected with sodium pentobarbital (35 mg / kg). -1 Mice that lost their righting reflex for more than 1 minute within 15 minutes were considered to have entered sleep. Record the sleep latency, number of mice sleeping, and sleep duration.

[0102] 4. Experimental Results

[0103] The results showed that, compared with the model group, the number of mice in the positive control group (diethylstilbestrol), and the low, medium, and high dose groups of the traditional Chinese medicine composition significantly increased, the latency period was significantly shortened, and the sleep time of the mice was prolonged. Compared with the model group, the activities of SOD and GSH-PX in the serum of mice in the diethylstilbestrol group and the high dose group of the traditional Chinese medicine composition were significantly increased, and the MDA content was significantly decreased. The results are shown in Tables 2 and 3.

[0104] Table 2. Effects of traditional Chinese medicine composition on pentobarbital sodium-induced sleep in castrated female mice.

[0105]

[0106] Note: Compared with the model group, *P<0.05, **P<0.01.

[0107] Table 3. Effects of the traditional Chinese medicine composition on serum SOD, MDA, and GSH-PX levels in castrated female mice.

[0108]

[0109] Note: Compared with the blank control group, # P<0.05, ## P<0.01; compared with the model control group, *P<0.05, **P<0.01.

[0110] The composition proposed in this invention can significantly increase the levels of estradiol (E2) and progesterone (P) in the serum of castrated female rats, and significantly reduce the levels of follicle-stimulating hormone (FSH) and luteinizing hormone (LH). The composition also increases the number of sleepers, reduces sleep latency, and prolongs sleep time in sodium pentobarbital-induced castrated female mice. Furthermore, it significantly increases the activities of superoxide dismutase (SOD) and glutathione peroxidase (GSH-PX) in the serum of castrated female mice, and reduces malondialdehyde (MDA) levels. In conclusion, the composition of this invention has a definite therapeutic effect on menopausal syndrome.

[0111] The above embodiments of the present invention are merely examples to clearly illustrate the present invention and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of a medicament for the prevention and / or treatment of menopausal syndrome, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight:

2. The application as described in claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight:

3. The application as described in claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight:

4. The application as described in claim 1, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight:

5. The application as described in any one of claims 1 to 4, characterized in that, The preparation method of the traditional Chinese medicine composition includes the following steps: Step 1: Add water to the prescribed amount of Polygonum multiflorum, Dipsacus asper, and Atractylodes macrocephala and decoct. Filter the solution, combine the filtrates, concentrate them into an extract, cool to room temperature, add ethanol to the extract, let it stand, take the supernatant, recover the ethanol, concentrate it into a second concentration to obtain the first extract, filter it for later use. Step 2: Add water to the prescribed amounts of turtle shell, wolfberry, and poria cocos and decoct. Filter the decoction, combine the filtrates, and concentrate them in a third stage to obtain the second extract. Filter the extract and set it aside. Step 3: Combine the first extract and the second extract and mix well.

6. The application as described in claim 5, characterized in that, The first concentration in step 1 is: concentrating at 50–80°C to a relative density of 1.10–1.15; and / or The amount of water added in step 1 is 8 times the original amount of medicine; and / or The decoction process described in step 1 is performed three times, each time for one hour; and / or The addition of ethanol in step 1 is to achieve an alcohol content of 60% (v / v); and / or The settling time mentioned in step 1 is at least 12 hours; and / or The second concentration in step 1 is: concentrating at 50–80°C to a relative density of 1.20–1.23; and / or The third concentration mentioned in step 2 is: concentrating at 50–80°C to a relative density of 1.20–1.23; and / or The amount of water added in step 2 is 8 times the original amount of medicine; and / or The simmering process described in step 1 is repeated 3 times, with each simmering lasting 1 hour.

7. The application as described in any one of claims 1 to 6, characterized in that, The drug includes any of the following and pharmaceutically acceptable excipients: (I) The traditional Chinese medicine composition; or (II) The traditional Chinese medicine composition prepared by the above method.

8. The application as described in claim 7, characterized in that, The excipients include steviol glycosides and / or dextrin; Preferably, by weight, it includes: 5 parts of steviol glycosides; 40-70 parts of dextrin.

9. The application as described in any one of claims 1 to 8, characterized in that, The dosage form of the drug includes one or more of oral dosage forms, injectable dosage forms, or topical dosage forms; Preferably, the dosage form of the drug includes one or more of the following: decoction, granules, capsules, tablets, oral liquid, pills, tinctures, syrups, gels, sprays, or injections.

10. The application as described in any one of claims 7 to 9, characterized in that, The method for preparing the drug includes the following steps: The traditional Chinese medicine composition was prepared according to the described preparation method; Add the amounts of steviol glycosides and / or dextrin specified in the formula, and granulate.

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