A traditional Chinese medicine composition for treating menopausal syndrome, a preparation method thereof and application thereof

Abstract

This invention relates to a traditional Chinese medicine composition for treating menopausal syndrome, its preparation method, and its application. The composition comprises the following raw materials: stir-fried Sophora japonica fruit, stir-fried Cuscuta chinensis seed, Acanthopanax senticosus, Poria cocos, Armillaria mellea, Astragalus membranaceus, American ginseng, donkey-hide gelatin, Lycium barbarum, Cordyceps sinensis mycelium powder, and chitosan. The components of this invention are carefully developed based on the fundamental symptoms of liver and kidney yin deficiency, combining classic prescriptions from ancient Chinese medicine texts with currently used clinical remedies. The formula of this invention focuses on tonifying deficiency, specifically using qi-tonifying, yang-tonifying, and yin-tonifying herbs, supplemented with calming herbs to treat symptoms such as irritability and insomnia, and further enhanced with blood-activating and stasis-removing herbs to regulate blood circulation. The combination of these herbs complements each other, achieving the effects of tonifying the liver and kidneys, nourishing yin and qi, activating blood circulation and regulating menstruation, and calming the mind and regulating qi. It is effective for various types of menopausal syndrome in women, with strong universality and significant therapeutic effects.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition for treating menopausal syndrome, its preparation method, and its application. Background Technology

[0002] Menopausal syndrome refers to a group of symptoms in women around the time of menopause, primarily characterized by autonomic nervous system dysfunction and accompanied by neuropsychological symptoms, caused by endocrine changes. Common clinical manifestations include menstrual irregularities, hot flashes, night sweats, irritability, insomnia, mood swings, and depression. Traditional Chinese medicine refers to these symptoms as "pre- and post-menopausal symptoms" or "pre- and post-menopausal symptoms."

[0003] Modern medicine indicates that after women enter menopause, the loss or decline of ovarian function leads to significant changes in sex hormone levels, primarily manifested as a decrease in E2 and an increase in FSH and LH. This disrupts the balance of the hypothalamus-pituitary-gonadal axis, resulting in endocrine disorders and is the main cause of menopausal syndrome. Currently, modern medicine mainly uses hormone replacement therapy, which is relatively simple, has many adverse reactions, and may increase the incidence of uterine, ovarian, and breast cancer, endangering health and life. In contrast, traditional Chinese medicine can rival hormone replacement therapy in efficacy without the associated risks.

[0004] Traditional Chinese medicine (TCM) believes that the root cause of "premenopausal symptoms" is kidney deficiency. An imbalance of Yin and Yang in the kidneys subsequently affects multiple organs, including the heart, liver, and spleen, leading to pathological changes and triggering the disease. TCM offers a dialectical treatment plan for this condition. Clinical medications include ancient formulas such as Zuogui Wan and Liuwei Dihuang Wan, as well as modern clinicians' self-formulated prescriptions such as Kun'an Ning and Danggui Liuhuang Tang. While these formulas each have their own characteristics, the diagnostic criteria for this disease vary greatly, are highly flexible, and lack uniformity, thus limiting their universal applicability.

[0005] Therefore, there is an urgent need to develop a versatile and comprehensive traditional Chinese medicine composition for treating menopausal syndrome. Summary of the Invention

[0006] The technical problem to be solved by the present invention is: the present invention provides a traditional Chinese medicine composition for treating menopausal syndrome, its preparation method and application. The traditional Chinese medicine composition is formulated with traditional Chinese medicine materials, fungal materials and chitosan. It has a novel approach, strong versatility and can effectively relieve and treat menopausal syndrome of various syndrome differentiation types.

[0007] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is as follows:

[0008] This invention provides a traditional Chinese medicine composition for treating menopausal syndrome, comprising the following traditional Chinese medicine raw material components:

[0009] Stir-fried Sophora japonica fruit, stir-fried Cuscuta chinensis, Acanthopanax senticosus, Poria cocos, Armillaria mellea, Astragalus membranaceus, American ginseng, donkey-hide gelatin, wolfberry, Cordyceps mycelium powder, chitosan.

[0010] This invention proposes a traditional Chinese medicine composition for treating menopausal syndrome. Based on the traditional Chinese medicine view that menopause is characterized by liver and kidney yin deficiency, and that treatment should focus on tonifying the liver and kidneys, nourishing yin, and clearing heat, this composition is carefully developed by combining classic prescriptions from ancient Chinese medical texts with proven clinical formulas. In this formula, Astragalus membranaceus, combined with Acanthopanax senticosus and American ginseng, enhances the effects of tonifying the spleen and kidneys, replenishing qi, and combating fatigue; Lycium barbarum has the function of nourishing yin and replenishing qi, and its combination with Astragalus membranaceus and American ginseng enhances the qi-replenishing effect; Cordyceps mycelium powder, combined with Cuscuta chinensis, has the effects of tonifying yang and kidneys, used to treat kidney deficiency, lower back pain, weak legs, and mental fatigue; Poria cocos has the function of calming the mind and soothing the nerves; Donkey-hide gelatin has the effect of replenishing blood and nourishing yin; Chitosan can effectively regulate the autonomic nervous system and endocrine function, and improve the body's immunity. The formula of this invention focuses on tonifying deficiency, specifically using qi-tonifying, yang-tonifying, and yin-tonifying herbs as the main components, supplemented by calming herbs to treat symptoms such as irritability and insomnia, and further enhanced with blood-activating and stasis-removing herbs to regulate blood circulation. The combination of these herbs complements each other, working synergistically to tonify the liver and kidneys, nourish yin and qi, activate blood circulation and regulate menstruation, and calm the mind and regulate qi. It is effective for various types of menopausal syndrome in women, exhibiting strong universality and significant therapeutic effects.

[0011] Preferably, the traditional Chinese medicine composition for treating menopausal syndrome comprises the following parts by weight of traditional Chinese medicine raw materials:

[0012] 10-40 parts of stir-fried Sophora japonica fruit, 6-18 parts of stir-fried Cuscuta chinensis, 6-18 parts of Acanthopanax senticosus, 5-15 parts of Poria cocos, 1-3 parts of Armillaria mellea, 1-5 parts of Astragalus membranaceus, 1-5 parts of American ginseng, 1-5 parts of donkey-hide gelatin, 1-5 parts of wolfberry, 1-5 parts of Cordyceps sinensis mycelium powder, and 0.5-2 parts of chitosan.

[0013] Most preferably, the traditional Chinese medicine composition for treating menopausal syndrome comprises the following parts by weight of traditional Chinese medicine raw materials:

[0014] 30 parts of stir-fried Sophora japonica fruit, 12 parts of stir-fried Cuscuta chinensis, 12 parts of Acanthopanax senticosus, 8.4 parts of Poria cocos, 1.8 parts of Armillaria mellea, 1.8 parts of Astragalus membranaceus, 1.8 parts of American ginseng, 1.8 parts of donkey-hide gelatin, 1.8 parts of wolfberry, 1.8 parts of Cordyceps mycelium powder, and 0.9 parts of chitosan.

[0015] The properties, meridian tropism, and efficacy of the traditional Chinese medicine components used in this invention are as follows:

[0016] Sophora japonica fruit: bitter in taste and cold in nature; enters the liver and large intestine meridians; belongs to the category of blood-cooling hemostatic drugs under the hemostatic drug classification, and has the functions of clearing heat and purging fire, cooling blood and stopping bleeding.

[0017] Cuscuta seed: It has a pungent and sweet taste and a neutral nature; it enters the liver, kidney, and spleen meridians; it belongs to the yang-tonifying medicine category under the tonifying medicine classification, and has the effects of tonifying the kidney and replenishing essence, nourishing the liver and improving eyesight.

[0018] Acanthopanax senticosus: It has a pungent and slightly bitter taste and is warm in nature; it enters the spleen, kidney, and heart meridians; it belongs to the category of qi-tonifying herbs under the category of tonifying deficiency herbs, and has the effects of invigorating qi and strengthening the spleen, tonifying the kidneys and calming the mind.

[0019] Poria cocos: It has a sweet and bland taste and a neutral nature; it enters the heart and spleen meridians; it belongs to the category of calming and tranquilizing drugs, and has the effects of calming the mind, promoting diuresis and eliminating dampness, and strengthening the spleen and replenishing the middle jiao.

[0020] Armillaria mellea: sweet in taste and neutral in nature; enters the liver meridian; belongs to the category of wind-relieving and spasm-stopping drugs under the category of liver-calming and wind-extinguishing drugs, and has the effects of calming the liver, extinguishing wind, stopping spasms, dispelling wind, and unblocking the meridians.

[0021] Astragalus: It has a sweet taste and slightly warm nature; it enters the spleen and lung meridians; it belongs to the category of qi-tonifying herbs under the category of tonifying deficiency herbs, and has the functions of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, generating fluids and nourishing blood, promoting circulation and relieving pain, promoting the elimination of toxins and pus, and promoting wound healing and tissue regeneration.

[0022] American ginseng: It tastes sweet and slightly bitter, and is cool in nature; it enters the heart, lung, and kidney meridians; it belongs to the category of qi-tonifying herbs under the category of tonifying deficiency herbs, and has the functions of tonifying qi and nourishing yin, clearing heat and generating fluids.

[0023] Donkey-hide gelatin: It has a sweet taste and neutral properties; it enters the lung, liver, and kidney meridians; it belongs to the blood-tonifying medicine category under the tonifying medicine classification, and has the functions of tonifying blood, nourishing yin, moistening the lungs, and stopping bleeding.

[0024] Goji berries: sweet in taste and neutral in nature; they enter the liver and kidney meridians; they belong to the yin-tonifying category of tonifying herbs, and have the effects of nourishing the liver and kidneys, benefiting essence and improving eyesight.

[0025] Cordyceps mycelium: sweet in taste and neutral in nature; enters the lung and kidney meridians; belongs to the category of tonifying yang medicine under the category of tonifying deficiency medicine, and has the functions of tonifying the lung and kidney, stopping bleeding, and resolving phlegm.

[0026] Another aspect of the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0027] S1. Soak the stir-fried Sophora japonica fruit, stir-fried Cuscuta chinensis, Acanthopanax senticosus, Poria cocos, Armillaria mellea, Astragalus membranaceus, American ginseng, donkey-hide gelatin, wolfberry and Cordyceps mycelium powder in water, then decoct them, and combine the decoctions for vacuum concentration.

[0028] S2. Add chitosan to the above decoction, mix well, concentrate and dry to obtain an extract, which is the traditional Chinese medicine composition.

[0029] The method for preparing the traditional Chinese medicine composition described in this invention is simple, low-cost, and suitable for industrial production.

[0030] Preferably, in step S1, the soaking conditions include: the weight of water is 3-6 times the total weight of the initial Chinese herbal raw materials, and the soaking time is 30-90 minutes.

[0031] Preferably, in step S1, the conditions for decocting include: decocting more than twice, each decoction lasting 45 minutes, and the amount of water used for each decoction being 10 times the total weight of the Chinese herbal raw materials.

[0032] Preferably, in steps S1 and S2, the concentration temperature is below 60°C.

[0033] In another aspect, the present invention provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a medicament for treating menopausal syndrome.

[0034] Preferably, the drug is further formulated into an oral preparation by adding pharmaceutically acceptable excipients, including tablets, capsules, granules, pills, or oral liquid preparations. Attached Figure Description

[0035] Figure 1 Comparative images of uterine tissue morphology in mice from different groups in the experimental examples of this invention (HE staining, ×200);

[0036] Figure 2 This is a graph showing the effect of ovarian removal on the expression of Bcl-2, Bax, Caspase-3, and Caspase-9 mRNA in the mouse uterus in the experimental examples of this invention;

[0037] Figure 3 This diagram illustrates the effects of different groups of mice on the expression of Bcl-2, Bax, Caspase-3, and Caspase-9 mRNA in the experimental examples of this invention. Detailed Implementation

[0038] To better understand the above technical solutions, exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that the present invention can be understood more clearly and thoroughly, and that the scope of the present invention can be fully conveyed to those skilled in the art.

[0039] Example 1

[0040] A traditional Chinese medicine composition for treating menopausal syndrome, comprising the following parts by weight of traditional Chinese medicine raw materials:

[0041] 30 parts of stir-fried Sophora japonica fruit, 12 parts of stir-fried Cuscuta chinensis, 12 parts of Acanthopanax senticosus, 8.4 parts of Poria cocos, 1.8 parts of Armillaria mellea, 1.8 parts of Astragalus membranaceus, 1.8 parts of American ginseng, 1.8 parts of donkey-hide gelatin, 1.8 parts of wolfberry, 1.8 parts of Cordyceps mycelium powder, and 0.9 parts of chitosan.

[0042] It is prepared by the following method:

[0043] S1. Soak stir-fried sophora japonica fruit, stir-fried cuscuta chinensis, acanthopanax senticosus, poria, armillaria mellea, astragalus membranaceus, american ginseng, donkey-hide gelatin, wolfberry fruit and cordyceps mycelium powder in water 3 - 6 times the total weight of the initial traditional Chinese medicine raw materials for 30 - 90 minutes, then add water for decoction. Decoct twice in total. Each time, add water to 10 times the total weight of the traditional Chinese medicine raw materials, and each decoction time is 45 minutes. Combine the decoction liquids and then conduct decompression concentration, with the concentration temperature below 60°C.

[0044] S2. Add chitosan to the above-mentioned decoction liquid, mix evenly, and conduct concentration and drying to obtain an extract, with the concentration temperature below 60°C, which is the traditional Chinese medicine composition mentioned above.

[0045] The above-mentioned traditional Chinese medicine composition can be used in the preparation of drugs for treating menopausal syndrome, and can further be made into oral preparations by adding pharmaceutically acceptable excipients, including tablets, capsules, granules, pills or liquid oral preparations.

[0046] Dilute the extract obtained in Example 1 with water 10 times the daily dosage of a human to obtain a high-concentration traditional Chinese medicine composition liquid; dilute it with water 5 times the daily dosage of a human to obtain a low-concentration traditional Chinese medicine composition liquid.

[0047] Comparative Example 1

[0048] The difference between this comparative example and Example 1 is that the commercially available drug Kuntai Capsule for treating menopausal syndrome is used as a positive control. Referring to the dosage in the instruction manual, dissolve Kuntai Capsule in water 10 times the daily dosage of a human to obtain Kuntai liquid.

[0049] Comparative Example 2

[0050] The difference between this comparative example and Example 1 is that the commercially available drug Fugengkang Capsule for treating menopausal syndrome is used as a positive control. Referring to the dosage in the instruction manual, dissolve Fugengkang Capsule in water 10 times the daily dosage of a human to obtain Fugengkang liquid.

[0051] Test Example

[0052] 1. Experimental animals

[0053] 75 SPF-grade female C57BL / 6 mice, weighing 18 - 22 g, were purchased from Shanghai Slack Experimental Animal Co., Ltd., and the experimental animal production license number is: SCXK(Shanghai)2022 - 0004.

[0054] 2. Experimental drugs

[0055] The test drug was the traditional Chinese medicine composition prepared in Example 1 of this invention (the daily adult dose is equivalent to 74.1g of raw drug); the positive control drugs were Kuntai Capsules (Guiyang Xintian Pharmaceutical Co., Ltd., batch number Z20000083, specification: 0.5g per capsule, clinical daily dose of 12 capsules) in Comparative Example 1 and Fugengkang Capsules (Anfa (Fujian) Biotechnology Co., Ltd., batch number G20130564, specification: 0.45g per capsule, clinical daily dose of 6 capsules) in Comparative Example 2.

[0056] 3. Experimental Methods

[0057] 3.1 Dosage of the drug

[0058] (1) Dosage of traditional Chinese medicine composition

[0059] Administer by gavage at a dose of 0.1 mL / 10 g body weight. The high and low concentration doses are 12.35 g / kg and 6.175 g / kg, respectively.

[0060] (2) Positive drug dosage

[0061] Take Kuntai capsule granules, dissolve them in water to make a 100mg / mL solution, administer the drug at a volume of 0.1mL / 10g body weight, and administer the drug to mice at a dose of 1g / kg.

[0062] Take Fugengkang capsule granules, dissolve them in water to make a 45mg / mL solution, administer the drug at a volume of 0.1mL / 10g body weight, and administer the drug to mice at a dose of 0.45g / kg.

[0063] 3.2 Model Preparation

[0064] Seventy-five 6-week-old female C57BL / 6 mice were housed in an SPF-grade environment. After one week of acclimatization, 10 mice were randomly selected as the blank control group. All mice were anesthetized with 7 mg / mL sodium pentobarbital (Sigma, batch number 201706), and their dorsal hair was removed. The skin and peritoneum were cut open. The blank control mice underwent only sham surgery without ovariectomy. The remaining mice had their fallopian tubes and fat ligated below the ovaries, and both ovaries were removed. The wounds were then sutured, and erythromycin ointment was applied to the wounds for antibacterial and anti-inflammatory purposes. One week later, vaginal smears were examined for five consecutive days. If no estrus response was observed for five consecutive days, the menopausal mouse model was successfully established.

[0065] 3.3 Group Dosing

[0066] Fifty ovariectomized mice that had not yet entered estrus and were still alive were selected and randomly divided into four groups (n=10 per group): a model group, a positive control group (Kuntai capsules), a positive control group (Fugengkang capsules), a low-concentration group (traditional Chinese medicine composition), and a high-concentration group (traditional Chinese medicine composition). Mice in each group were administered 0.1 mL / 10 g via gavage once daily for seven weeks. The blank control group and model group received an equal volume of water as a solvent, while the other groups received the corresponding drugs. Samples were collected for analysis after the administration was completed.

[0067] 3.4 Detection Indicators and Methods

[0068] 3.4.1 Uterine Index Detection

[0069] After the last administration, the mice were fasted and deprived of water for 24 hours. Each mouse was weighed and its weight was recorded. The mice were dissected, their uteruses were removed, excess tissue was removed, and the wet weight of the uterus was measured. The uterine index of the mice was calculated according to the formula "uterine index = wet weight of uterus (mg) ÷ body weight (g) × 100%". The average uterine index of each group of mice was taken.

[0070] 3.4.2 Serum hormone level measurement

[0071] Blood was collected by enucleating the eyeballs. After the blood sample was allowed to stand for 1 hour, it was centrifuged at 3000 rpm for 15 minutes. The supernatant was collected and the mouse serum was analyzed by ELISA according to the kit instructions.

[0072] 3.4.3 Histopathological morphological observation of uterine tissue

[0073] Mouse uterus was taken, fixed in 4% paraformaldehyde solution, embedded in paraffin, sectioned, stained with hematoxylin and eosin (HE), and the pathological changes of mouse uterine tissue in each group were observed under a light microscope. The light intensity of the sections was kept consistent, and the magnification was uniformly 200 times.

[0074] 3.4.4 Detection of Bcl-2, Bax, Caspase-3, and Caspase-9 mRNA expression in the uterus

[0075] Approximately 30 mg of mouse uterine tissue was collected, and total RNA was extracted using Trlzol reagent. After determining the RNA concentration and purity, it was reverse transcribed into cDNA. Primers corresponding to the target gene were designed and synthesized, using glyceraldehyde-3-phosphate dehydrogenase (GAPDH) as an internal reference gene. -ΔΔCt The relative expression level of the target gene was calculated using a method. Primers were synthesized by Sangon Biotech (Shanghai) Co., Ltd., and the primer sequences are shown in Table 1.

[0076] Table 1. PCR primer sequences for each gene

[0077]

[0078] 3.5 Statistical Processing Methods

[0079] All data were analyzed using Graphpad Prism 8.0 software. Experimental data are expressed as mean ± standard deviation (X±SD). The t-test was used to evaluate differences between groups. A p-value < 0.05 was considered statistically significant.

[0080] 4. Experimental Results

[0081] 4.1 Comparison of Uterine Indices

[0082] Table 2. Effects of each group on the uterine index in menopausal mice.

[0083]

[0084]

[0085] Note: Compared with the model group, *P<0.05; **P<0.01; ****P<0.0001; compared with the blank control group, #### P < 0.0001.

[0086] Table 2 shows that, compared with the blank control group, ovariectomy caused a certain degree of uterine atrophy in mice (P < 0.0001). Compared with the model group, the uterine index of model mice treated with high-concentration traditional Chinese medicine was significantly increased (P < 0.0001), and its effect was comparable to that of the Fugengkang group and the Kuntai group (P < 0.05, P < 0.01). Although the low-concentration traditional Chinese medicine group could increase the uterine index of menopausal model mice, the difference was not statistically significant (P > 0.05).

[0087] 4.2 Comparison of serum hormone levels

[0088] Table 3. Effects of each group on serum hormone levels in menopausal mice.

[0089]

[0090] Note: Compared with the model group, *P<0.05; **P<0.01; ***P<0.001; compared with the blank control group, ## P < 0.01; ### P < 0.001.

[0091] As shown in Table 3, compared with the blank control group, the serum E2 and T levels in the model group were significantly decreased (P < 0.001, P < 0.01), while the FSH and LH levels were significantly increased (P < 0.001, P < 0.01), indicating that the menopausal mouse model was successfully established. Compared with the model group, the serum E2 and T levels in the high-concentration traditional Chinese medicine group were significantly increased (P < 0.01), while the serum FSH and LH levels were significantly decreased (P < 0.05); the serum E2 and T levels in the low-concentration traditional Chinese medicine group were significantly increased (P < 0.05), while there was no significant difference in serum FSH level (P > 0.05), and the serum LH level was significantly decreased (P < 0.01). This indicates that the traditional Chinese medicine composition of the present invention has a significant effect on improving serum hormone levels in menopausal model mice, and the improvement in some serum hormone levels is even better than that in the positive control group.

[0092] 4.3 Comparison of uterine histopathological morphology

[0093] like Figure 1 As shown, the endometrium of mice in the blank control group was normal, with the outer, myometrial, and endometrial layers clearly visible, abundant glands and capillaries, large glandular lumens, and relatively loose connective tissue. Compared with the blank control group, the endometrium of mice in the model group was thinner, with fewer glands and capillaries, and a smaller thoracic cavity. After drug intervention, the endometrium of mice in each treatment group was significantly thickened, and the glandular lumens were enlarged. Among them, the high-concentration traditional Chinese medicine group and the Kuntai group were closer to the morphology of normal endometrium.

[0094] 4.4 Comparison of mRNA expression levels of Bcl-2, Bax, Caspase-3, and Caspase-9 in the uterus

[0095] from Figure 2 It can be seen that, compared with the blank control group, the expression of Bcl-2 mRNA in the uterine tissue of the model group mice was significantly decreased (P < 0.01), while the expression of Bax, Caspase-3, and Caspase-9 mRNA was significantly increased (P < 0.05, P < 0.01, P < 0.01). Combined with... Figure 3It was found that, compared with the model group, the expression of Bcl-2 mRNA in the uterine tissue of mice in the Fugengkang group was significantly increased (P < 0.001), while the expression of Caspase-3 and Caspase-9 mRNA was significantly decreased (P < 0.01, P < 0.01). There was no significant difference in mRNA expression (P>0.05). In the Kuntai group, Bcl-2 mRNA expression in the uterine tissue of mice was significantly increased (P<0.001), while Bax, Caspase-3, and Caspase-9 mRNA expression was significantly decreased (P<0.05, P<0.001, P<0.001). In the high-concentration traditional Chinese medicine group, Bcl-2 mRNA expression in the uterine tissue of mice was significantly increased (P<0.01), while Bax, Caspase-3, and Caspase-9 mRNA expression was significantly decreased (P<0.05, P<0.0001, P<0.0001). In the low-concentration traditional Chinese medicine group, Caspase-3 and Caspase-9 mRNA expression in the uterine tissue of mice was significantly decreased (P<0.05, P<0.05), while there was no significant difference in Bcl-2 and Bax mRNA expression (P>0.05).

[0096] The above results indicate that the combination of traditional Chinese medicine components used in this invention is reasonable, and the resulting traditional Chinese medicine composition has a significant effect on improving menopausal syndrome. Furthermore, the mechanism of action may be related to the inhibition of the caspase-dependent apoptosis pathway. The traditional Chinese medicine composition of this invention is derived from years of experience, summarization, and screening based on traditional Chinese medicine theory. After analysis, research, and verification, it possesses certain clinical value and has broad application prospects.

[0097] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A traditional Chinese medicine composition for treating menopausal syndrome, characterized in that, Composed of the following parts by weight of traditional Chinese medicine raw materials: 10-40 parts of stir-fried Sophora japonica fruit, 6-18 parts of stir-fried Cuscuta chinensis, 6-18 parts of Acanthopanax senticosus, 5-15 parts of Poria cocos, 1-3 parts of Armillaria mellea, 1-5 parts of Astragalus membranaceus, 1-5 parts of American ginseng, 1-5 parts of donkey-hide gelatin, 1-5 parts of wolfberry, 1-5 parts of Cordyceps sinensis mycelium powder, and 0.5-2 parts of chitosan.

2. The traditional Chinese medicine composition for treating menopausal syndrome as described in claim 1, characterized in that, Composed of the following parts by weight of traditional Chinese medicine raw materials: 30 parts of stir-fried Sophora japonica fruit, 12 parts of stir-fried Cuscuta chinensis, 12 parts of Acanthopanax senticosus, 8.4 parts of Poria cocos, 1.8 parts of Armillaria mellea, 1.8 parts of Astragalus membranaceus, 1.8 parts of American ginseng, 1.8 parts of donkey-hide gelatin, 1.8 parts of wolfberry, 1.8 parts of Cordyceps mycelium powder, and 0.9 parts of chitosan.

3. A method for preparing a traditional Chinese medicine composition as described in any one of claims 1-2, characterized in that, Includes the following steps: S1. Soak the stir-fried Sophora japonica fruit, stir-fried Cuscuta chinensis, Acanthopanax senticosus, Poria cocos, Armillaria mellea, Astragalus membranaceus, American ginseng, donkey-hide gelatin, wolfberry and Cordyceps mycelium powder in water, then decoct them, combine the decoctions and concentrate them under reduced pressure. S2. Add chitosan to the above decoction, mix well, concentrate and dry to obtain an extract, which is the traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that, In step S1, the soaking conditions include: the weight of water used is 3-6 times the total weight of the initial Chinese herbal raw materials, and the soaking time is 30-90 minutes.

5. The preparation method according to claim 3, characterized in that, In step S1, the conditions for decocting include: decocting more than twice, each decoction lasting 45 minutes, and the amount of water used for each decoction being 10 times the total weight of the Chinese medicinal materials.

6. The preparation method according to claim 3, characterized in that, In steps S1 and S2, the concentration temperature is below 60°C.

7. The use of a traditional Chinese medicine composition as described in any one of claims 1-2 in the preparation of a medicament for treating menopausal syndrome.

8. The application as described in claim 7, characterized in that, The drug is further formulated into an oral preparation by adding pharmaceutically acceptable excipients.

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