Traditional Chinese medicine composition for treating menopausal syndrome as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines and relates to a traditional Chinese medicine composition for treating menopausal syndrome as well as a preparation method and application thereof. The traditional Chinese medicine composition is prepared from 5-10 parts of rhizoma curculiginis, 5-10 parts of herba epimedii, 15-30 parts of radix morindae officinalis, 10-20 parts of radix angelicae sinensis, 5-10 parts of rhizoma anemarrhenae, 5-10 parts of cortex phellodendri, 60-100 parts of raw oyster shell, 30-50 parts of tortoise plastron, 10-20 parts of ramulus cinnamomi, 10-20 parts of radix paeoniae alba, 10-20 parts of honey-fried licorice root, 10-20 parts of fructus ziziphi jujubae and 10-20 parts The traditional Chinese medicine composition provided by the invention has the effects of tonifying yin and yang and regulating ying and wei. Clinical tests show that the traditional Chinese medicine composition can reduce and improve the KI score and hectic fever score of patients with the menopausal syndrome, and has higher safety.

Description

Technical Field

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

[0002] Menopausal syndrome (MPS) refers to a series of complex and diverse physical and mental symptoms that occur in women before and after menopause due to fluctuations or decreases in sex hormone levels. It is a common and frequently occurring disease in women during the transition period from reproductive age to old age.

[0003] With the rapid development of modern productivity and economic levels, women are playing increasingly important social roles in both work and life, while also shouldering greater pressure. Coupled with the aging population, the incidence of MPS is increasing year by year. Over 85% of women experience a range of MPS symptoms by a certain age, including varying degrees of hot flashes, insomnia, anxiety, depression, palpitations, dizziness, irritability, and bone loss. In later stages, these symptoms may be accompanied by significant osteoporosis, cognitive impairment, cardiovascular and cerebrovascular disease, and even serious events such as fractures and cardiovascular events.

[0004] Although menopause is a physiological process, the range of clinical symptoms it causes is often severe and long-lasting. Many of these symptoms disrupt normal life and work, pose significant long-term risks and hazards, and severely impact women's physical and mental health and quality of life. Improving the quality of life of perimenopausal women has been listed as one of the three major health priorities of the 21st century. MPS not only affects individuals physically and mentally but also impacts family harmony. Severe MPS and its long-term consequences impose a significant social burden, impacting national economic growth, social development, and stability. Therefore, preventing and treating MPS is of vital importance to women, their families, and society, and scientific management of the large population of women experiencing perimenopause is of paramount importance.

[0005] Many women with MPS are hesitant to use hormone replacement therapy (HRT) due to concerns and fear of hormones. Currently, HRT is the most commonly used Western medicine treatment for MPS, but it carries various disadvantages and adverse reactions. Long-term treatment, in particular, can increase the risk of breast cancer, ovarian cancer, endometrial hyperplasia, stroke, and venous thromboembolism. Furthermore, some women with MPS have contraindications to HRT. Therefore, HRT also has limitations.

[0006] Non-hormonal methods for treating MPS can benefit patients who are unable to receive hormone therapy, but to date, existing non-hormonal treatments are not ideal, so it is urgent to find a safe and effective treatment for MPS. Summary of the Invention

[0007] Based on this, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating menopausal syndrome and its preparation method and application, which has solved the problems in the prior art.

[0008] To achieve the above-mentioned purpose, the present invention adopts the following technical solutions.

[0009] The invention provides a traditional Chinese medicine composition for treating menopausal syndrome. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5-10 parts of curculigo, 5-10 parts of epimedium, 15-30 parts of Morinda officinalis, 10-20 parts of angelica, 5-10 parts of anemarrhena, 5-10 parts of phellodendron, 60-100 parts of raw oyster, 30-50 parts of tortoise shell, 10-20 parts of cassia twig, 10-20 parts of white peony root, 10-20 parts of roasted liquorice root, 10-20 parts of jujube and 10-20 parts of ginger.

[0010] MPS is classified as a perimenopausal syndrome in Traditional Chinese Medicine. Ancient medical texts lack dedicated chapters on this condition, often referring to it as a symptom of "visceral agitation," "lily disease," and "mellow hemorrhage in the elderly." The Yellow Emperor's Classic of Internal Medicine states, "At the age of 49, a woman's Ren meridian becomes weak, her Taichong meridian weakens, her Tiangui (or celestial essence) is depleted, and her earthly passages become blocked, leading to physical deterioration and childlessness." The 49th month is the age when menstruation ceases. The kidneys are the "foundation of innate constitution." When kidney qi is abundant, Tiangui (or celestial essence) arrives; when kidney qi is weak, Tiangui (or celestial essence) is depleted, and when menstruation ceases, this indicates that the fundamental pathogenesis of MPS in women is kidney deficiency.

[0011] Professor Luo Yuankai of Lingnan Luo's Gynecology believes that the pathogenesis of this disease is kidney deficiency (primarily kidney yin deficiency), but he also believes that kidney yang deficiency also exists. Both kidney yin and yang are deficient, and imbalance of yin and yang is a key pathogenesis of this disease. Research has found that yang deficiency has become a very common physical imbalance among modern people. As women age, kidney essence and qi gradually deplete, and physiologically, yang qi gradually declines from abundance. Furthermore, modern people's habit of eating raw and cold foods (fruits, cold drinks), or their poor lifestyle (staying up late, using air conditioning excessively), can damage yang qi and lead to kidney yang deficiency. Because yin and yang are interdependent, an imbalance in the kidneys can affect yin, leading to kidney yin deficiency. Over time, this leads to a state of both kidney yin and yang deficiency. Ying is yin, while Wei is yang. Under normal circumstances, Wei (from the exterior) descends inward, while Ying (from the interior) ascends outward. This continuous circulation maintains a harmonious balance between Ying and Wei. However, once the body is disturbed by internal or external factors, this dynamic balance is disrupted, leading to imbalances in Ying and Wei, and a myriad of illnesses can arise. As the degree of kidney deficiency and depletion of Tiangui increases, the previous situation of balanced Yin and Yang, and harmonious Ying and Wei is broken, and the Ying and Wei become uncoordinated.

[0012] Therefore, based on the above theory, the present invention proposes that the pathogenesis of MPS in modern women is "kidney deficiency and imbalance of the Ying and Wei systems," establishing a treatment approach of "tonifying the kidney and regulating the Ying and Wei systems." The inventors independently formulated the Chinese herbal composition described herein for the treatment of menopausal syndrome. The decoction prepared from this composition is named Guixian Decoction and has been transformed into an in-hospital preparation, Guixian Mixture. This will not only overcome the inconveniences of traditional decoctions in terms of administration and portability, but also lay the foundation for its widespread clinical application, promote the modernization of Traditional Chinese Medicine treatment options, and thus benefit more patients and enhance therapeutic efficacy.

[0013] In some embodiments of the present invention, the drug is prepared from the following raw materials in parts by weight: 5-9 parts of Curculigo, 5-9 parts of Epimedium, 15-25 parts of Morinda officinalis, 10-19 parts of Angelica sinensis, 5-9 parts of Anemarrhena asphodeloides, 5-9 parts of Phellodendron chinense, 60-90 parts of raw oyster, 30-45 parts of tortoise shell, 10-18 parts of cinnamon twig, 10-19 parts of white peony root, 10-19 parts of roasted liquorice, 10-18 parts of jujube, and 10-15 parts of ginger.

[0014] In some embodiments of the present invention, the drug is prepared from the following raw materials in parts by weight: 5-7 parts of Curculigo, 5-7 parts of Epimedium, 15-18 parts of Morinda officinalis, 10-13 parts of Angelica sinensis, 5-6 parts of Anemarrhena asphodeloides, 5-6 parts of Phellodendron chinense, 60-70 parts of raw oyster, 30-35 parts of tortoise shell, 10-13 parts of cinnamon twig, 10-15 parts of white peony root, 10-15 parts of roasted liquorice root, 10-15 parts of jujube, and 10-12 parts of ginger.

[0015] The present invention also provides a preparation method of the traditional Chinese medicine composition, comprising: weighing curculigo, epimedium, Morinda officinalis, angelica, anemarrhena, phellodendron, raw oyster, tortoise shell, cinnamon twig, white peony root, roasted liquorice, jujube and ginger according to a proportion and extracting with water to obtain the composition.

[0016] In some embodiments of the present invention, the amount of water is 5 to 7 times the amount of the raw material drug in the traditional Chinese medicine composition.

[0017] In some embodiments of the present invention, the extraction method is selected from any one of a decoction method, a heating reflux method, or an ultrasonic extraction method.

[0018] In some embodiments of the present invention, the decoction method comprises: soaking the raw material drug in 5 to 7 times the amount of water for 20 to 35 minutes, boiling over high heat for 10 to 15 minutes, and then simmering over low heat for 1 hour to 1.5 hours, and decocting 2 to 3 times.

[0019] The present invention also provides a medicine for treating menopausal syndrome, wherein the medicine uses the traditional Chinese medicine composition as an active ingredient.

[0020] In some embodiments of the present invention, the drug further comprises a pharmaceutically acceptable excipient.

[0021] In some embodiments of the present invention, the pharmaceutically acceptable excipients include one or more of flavoring agents, preservatives, diluents, binders, disintegrants, lubricants, fragrances, excipients, wetting agents, capsule materials, plasticizers, opacifiers, colorants, coating materials, antioxidants, solubilizers, or suspending agents.

[0022] Specifically, in some embodiments of the present invention, the flavoring agent is selected from one or more of sucrose, honey, steviol glycosides, and aspartame.

[0023] The preservatives include one or more of benzoic acid, sodium benzoate, sorbic acid, and potassium sorbate; the diluents include one or more of lactose, sucrose, starch, dextrin, and mannitol; the binders include one or more of povidone, hydroxypropyl methylcellulose, and starch slurry; the disintegrants include one or more of sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, sodium bicarbonate, and citric acid; the lubricants include one or more of magnesium stearate, micropowdered silica gel, talc, and stearic acid; the fragrances include one or more of tangerine peel volatile oil, menthol, borneol, and essence; the excipients The agent includes one or more of honey, rice paste, flour paste, water, and medicinal juice; the capsule material includes gelatin or hydroxypropyl methylcellulose; the plasticizer includes glycerol or sorbitol; the sunscreen includes one or more of titanium dioxide, iron oxides, zinc oxide, and barium sulfate; the coating material includes a sugar coating or a film coating; the antioxidant includes one or more of sodium sulfite, vitamin C, sodium thiosulfate, and propyl gallate; the solubilizer includes one or more of polysorbate 80, poloxamer, and lecithin; and the suspending agent includes one or more of sodium carboxymethyl cellulose, gum arabic, glycerol, and gelatin.

[0024] In some embodiments of the present invention, the dosage form of the drug is a decoction, granules, pills, capsules, tablets, powders or oral liquids.

[0025] The present invention also provides the use of the traditional Chinese medicine composition in preparing medicine for treating menopausal syndrome.

[0026] The compatibility relationship in the Chinese medicine composition is as follows:

[0027] Main medicines: Curculigo orchioides, Epimedium brevicornum, Morinda officinalis, and cinnamon twig.

[0028] Assistant medicines: angelica, oyster, tortoise shell, white peony root.

[0029] Auxiliary drugs: Anemarrhena asphodeloides, Phellodendron chinense.

[0030] Auxiliary medicines: roasted licorice, jujube, and ginger.

[0031] The traditional Chinese medicine composition provided by the present invention is a self-developed formula. Based on the pathogenesis of MPS (muscular stagnation syndrome) characterized by "kidney deficiency and imbalance of nutrient and defensive systems," the inventors established a "tonifying the kidney and regulating nutrient and defensive systems" treatment approach. In the formula, Curculigo, Epimedium, and Morinda officinalis nourish kidney essence and warm kidney yang. Sufficient kidney essence, under the warming effect of kidney yang, transforms qi into yin. Combined with Chinese Angelica sinensis, it nourishes and replenishes blood, emphasizing the principle that "essence and blood share the same origin." Anemarrhena and Phellodendron amurense nourish yin and moisten dryness, preventing excessive warming and drying effects from the warming yang agents. The entire formula works to tonify the kidney's nutrient and defensive systems, replenishing the deficiencies in the kidneys of MPS patients. In the formula, cinnamon twig promotes yang and regulates defensive systems, while white peony root astringes yin and harmonizes nutrient and defensive systems. This approach integrates external and internal functions, balancing nutrient and defensive systems. Roasted licorice root invigorates qi and harmonizes the middle, and, together with cinnamon twig's pungent and sweet properties for yang transformation and white peony root's sour and sweet properties for yin transformation, jujube nourishes the middle and assists white peony root in yin. Ginger warms the stomach and assists cinnamon twig in promoting yang. The modified herb turtle shell nourishes yin and suppresses yang, tonifying the kidneys and strengthening bones, renowned for its ability to replenish true yin. "Those who are adept at replenishing yang must seek yang within yin; yang, aided by yin, will thrive." Adding turtle shell to yang-tonifying herbs has the virtue of promoting yang and strengthening yin. Raw oysters can calm, consolidate, and soothe the mind, allowing yang to be consolidated and yin to be internalized. Combining them with cassia twigs, as recorded in the "Jiangxueyuan Ancient Prescriptions Selection and Annotation," states: "The stubborn and pure nature of oysters is potent when combined with cassia twigs." Oysters benefit from the cassia twigs to prevent the suppression of yang. These herbs combined can either "seek yang within yin" or "seek yin within yang," achieving "balanced yin and yang, harmonious yin and wei."

[0032] Compared with the prior art, the technical solution provided by the present invention has the following beneficial effects:

[0033] The traditional Chinese medicine composition of the present invention has the efficacy of tonifying yin and yang and harmonizing the Ying and Wei systems. Clinical trials have shown that this traditional Chinese medicine composition can reduce and improve the KI score and hot flash score in patients with menopausal syndrome. Its efficacy in improving clinical symptoms is non-inferior to that of climonadine, and its safety is superior to that of climonadine. It comprehensively improves the quality of life and life expectancy of patients and is worthy of clinical promotion.

[0034] Compared with hormone replacement therapy, the Chinese medicine composition for treating menopause provided by the present invention has the advantages of multi-target action, mild efficacy and few side effects, and has become a popular treatment for MPS.

[0035] The present invention also found that the use of the Chinese medicine composition of the present invention can improve the blood lipid metabolism of the menopausal syndrome rat model, effectively reduce the total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C) levels in the menopausal syndrome rat model, and increase the low-density lipoprotein cholesterol (HDL-C) level. In addition, the use of a high dose (1.5 to 3.0 times the recommended dose of the Chinese medicine composition provided by the present invention) of the Chinese medicine composition has a significant advantage in regulating blood lipids compared to a lower dose (0.5 to 1.5 times the recommended dose of the Chinese medicine composition provided by the present invention). BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1This is a flow chart for the preparation of the Chinese medicine composition provided by the present invention. DETAILED DESCRIPTION

[0037] The experimental methods in the following examples of the present invention, where specific conditions are not specified, are generally carried out under conventional conditions or conditions recommended by the manufacturers.

[0038] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those commonly understood by those skilled in the art. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0039] The following describes the details in conjunction with specific embodiments.

[0040] Example 1: A Chinese medicine composition for treating menopausal syndrome

[0041] A traditional Chinese medicine composition for treating menopausal syndrome comprises: 5g of Curculigo orchioides, 5g of Epimedium, 15g of Morinda officinalis, 10g of Angelica sinensis, 5g of Anemarrhena asphodeloides, 5g of Phellodendron amurense, 60g of raw oyster, 30g of tortoise shell, 10g of cinnamon twig, 10g of white peony root, 10g of roasted liquorice root, 10g of jujube, and 10g of ginger.

[0042] The preparation method of the Chinese medicine composition described in this embodiment is as follows: Figure 1 As shown, the details are as follows:

[0043] 1. Inspection and screening of Chinese medicinal materials

[0044] Before Chinese medicinal materials enter processing, they undergo rigorous inspection. According to relevant quality standards (the Pharmacopoeia of the People's Republic of China), their appearance, color, odor, and impurity content are checked to ensure they meet the requirements for medicinal use. Screening removes moldy, insect-infested, and substandard herbs to ensure the highest quality before processing.

[0045] 2. Decoction extraction

[0046] The screened Chinese medicinal materials were accurately weighed according to the formula ratio, and 5 times the amount of water was added to soak for 30 minutes. The mixture was then boiled over high heat for 10 minutes, then simmered over low heat for another hour. The mixture was then filtered, the residue was collected, and the filtrate was saved. The above process was repeated to decoct the residue a second time, so that the active ingredients in the medicinal materials were fully dissolved in the water. After the decoction was completed, the two filtrates were collected and combined to obtain the decoction described in this example.

[0047] 3. Sterilization and filtration

[0048] To prevent microbial contamination and ensure product safety, the liquid is sterilized at 121°C for 15 minutes. After sterilization, it is filtered to remove any insoluble particles and maintain a clarity of 20-50 NTU.

[0049] 4. Finished product inspection

[0050] Finished products that have passed the inspection will be packaged in accordance with the prescribed packaging specifications using appropriate packaging materials, such as glass bottles, plastic bottles, etc. At the same time, the product name, specifications, production date, expiration date, manufacturer and other information must be clearly marked on the packaging for easy identification and traceability.

[0051] 5. Packaging and labeling

[0052] Finished products that have passed the inspection will be packaged in accordance with the prescribed packaging specifications using appropriate packaging materials, such as glass bottles, plastic bottles, etc. At the same time, the product name, specifications, production date, expiration date, manufacturer and other information must be clearly marked on the packaging for easy identification and traceability.

[0053] 6. Storage

[0054] Store packaged finished products under specified storage conditions, such as a cool, dry, and ventilated warehouse, and regularly inspect inventory products to ensure stable product quality within the shelf life.

[0055] 7. Quality control and traceability

[0056] Throughout the entire manufacturing process, we have established a comprehensive quality control system to strictly monitor each link to ensure the consistency and stability of product quality. At the same time, we have established a product traceability system to record information from the purchase of raw materials to the sale of finished products. This allows us to quickly and accurately trace the cause of any quality issues and take appropriate measures.

[0057] Example 2: A Chinese medicine composition for treating menopausal syndrome

[0058] A traditional Chinese medicine composition for treating menopausal syndrome comprises: 10g of Curculigo orchioides, 10g of Epimedium, 30g of Morinda officinalis, 20g of Angelica sinensis, 10g of Anemarrhena asphodeloides, 10g of Phellodendron amurense, 100g of raw oyster, 50g of tortoise shell, 20g of cinnamon twig, 20g of white peony root, 20g of roasted liquorice root, 20g of jujube, and 20g of ginger.

[0059] The preparation method of the Chinese medicine composition described in this embodiment differs from the preparation method described in Example 1 in terms of sterilization and filtration, and the other methods are the same. Specifically, in this embodiment, the sterilization and filtration methods are as follows: sterilizing the medicinal solution by irradiation sterilization and filtering after sterilization.

[0060] Conditions for irradiation sterilization: The irradiation source is 60Coγ rays with an activity of 30,000Ci; the irradiation dose is between 2 and 10 kGy, and the theoretical irradiation time is calculated based on the irradiation dose and the intensity of the irradiation source.

[0061] Example 3: A Chinese medicine composition for treating menopausal syndrome

[0062] A traditional Chinese medicine composition for treating menopausal syndrome comprises: 5g of Curculigo orchioides, 5g of Epimedium, 15g of Morinda officinalis, 10g of Angelica sinensis, 5g of Anemarrhena asphodeloides, 5g of Phellodendron amurense, 60g of raw oyster, 30g of tortoise shell, 10g of cinnamon twig, 10g of white peony root, 10g of roasted liquorice root, 10g of jujube, and 10g of ginger.

[0063] The preparation method of the Chinese medicine composition provided in this embodiment differs from the preparation method shown in Example 1 in that the decoction extraction method is different, and the other methods are the same. Specifically, in this embodiment, the decoction extraction method is as follows: the screened Chinese medicinal materials are accurately weighed according to the formula ratio, 6 times the amount of water is added to the medicinal materials and soaked for 20 minutes, then boiled over high heat for 12 minutes, then simmered for another 1.5 hours; then filtered, the medicinal residues were collected, the filtrate was saved, and the above operation was repeated again to decoct the medicinal residues twice so that the active ingredients in the medicinal materials are fully dissolved in water. After the end, the two filtrates were collected and combined to obtain the decoction provided in this embodiment.

[0064] Example 4: A Chinese medicine composition for treating menopausal syndrome

[0065] A traditional Chinese medicine composition for treating menopausal syndrome comprises: 9g of Curculigo orchioides, 9g of Epimedium, 25g of Morinda officinalis, 19g of Angelica sinensis, 9g of Anemarrhena asphodeloides, 9g of Phellodendron amurense, 90g of raw oyster, 45g of tortoise shell, 18g of cinnamon twig, 19g of white peony root, 19g of roasted liquorice root, 18g of jujube, and 15g of ginger.

[0066] The preparation method of the Chinese medicine composition provided in this embodiment differs from the preparation method shown in Example 1 in that the method of decoction extraction is different, and the other methods are the same. Specifically, in this embodiment, the method of decoction extraction is as follows: the screened Chinese medicinal materials are accurately weighed according to the formula ratio, 7 times the amount of water is added to the medicinal materials and soaked for 35 minutes, then boiled over high heat for 15 minutes, and then simmered for another 1.5 hours; then filtered, the medicinal residues were collected, the filtrate was saved, and the above operation was repeated to decoct the medicinal residues three times in total, so that the active ingredients in the medicinal materials are fully dissolved in water. After the end, the three filtrates were collected and combined to obtain the decoction provided in this embodiment.

[0067] Example 5: A Chinese medicine composition for treating menopausal syndrome

[0068] A traditional Chinese medicine composition for treating menopausal syndrome comprises: 7g of Curculigo orchioides, 7g of Epimedium, 20g of Morinda officinalis, 13g of Angelica sinensis, 6g of Anemarrhena asphodeloides, 6g of Phellodendron chinense, 70g of raw oyster, 35g of tortoise shell, 13g of cinnamon twig, 15g of white peony root, 15g of roasted liquorice root, 15g of jujube, and 12g of ginger.

[0069] The preparation method of the Chinese medicine composition provided in this example is the same as that in Example 2.

[0070] Example 6: A Chinese medicine composition for treating menopausal syndrome

[0071] A traditional Chinese medicine composition for treating menopausal syndrome comprises: 8g of Curculigo orchioides, 8g of Epimedium, 23g of Morinda officinalis, 15g of Angelica sinensis, 8g of Anemarrhena asphodeloides, 7g of Phellodendron chinense, 80g of raw oyster, 40g of tortoise shell, 15g of cinnamon twig, 18g of white peony root, 17g of roasted liquorice root, 17g of jujube, and 13g of ginger.

[0072] The preparation method of the Chinese medicine composition provided in this example is the same as that in Example 3.

[0073] Example 7: A Chinese medicine composition for treating menopausal syndrome

[0074] A traditional Chinese medicine composition for treating menopausal syndrome comprises: 6g of Curculigo orchioides, 6g of Epimedium, 17g of Morinda officinalis, 12g of Angelica sinensis, 6g of Anemarrhena asphodeloides, 6g of Phellodendron amurense, 65g of raw oyster, 33g of tortoise shell, 12g of cinnamon twig, 13g of white peony root, 13g of roasted liquorice root, 13g of jujube, and 11g of ginger.

[0075] The preparation method of the Chinese medicine composition provided in this example is the same as that in Example 4.

[0076] Since Examples 1 to 7 all prepared Chinese medicinal compositions with the expected effects of the present invention and all achieved the effect of treating menopausal syndrome, the following only uses the Chinese medicinal composition provided in Example 1 as an example to illustrate the effects.

[0077] Clinical research on the treatment of female menopausal syndrome using the traditional Chinese medicine compositions provided in Examples 1 to 5 of the present invention.

[0078] 1. Materials and methods

[0079] (1) Clinical cases and groups

[0080] 1) General Information

[0081] Menopausal status, number of births, number of miscarriages, education level, marital status, body mass index, and waist-to-hip ratio.

[0082] 2) Diagnostic criteria

[0083] (a) According to the diagnostic criteria for female perimenopausal syndrome in the Guiding Principles for Clinical Research of New Chinese Medicines.

[0084] For women aged 45 to 55, in addition to menstrual disorders, hot flashes and sweating are typical specific symptoms, which may be accompanied by clinical symptoms such as irritability, palpitations and insomnia, chest tightness and headache, abnormal emotions, memory loss, blood pressure fluctuations, and back and leg pain.

[0085] Endocrine measurements: serum estradiol (E2) decreased (lower than the early follicular level), and follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels increased.

[0086] (b) Refer to the diagnostic criteria for pre- and post-menopausal syndromes in the “Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes” issued by the State Administration of Traditional Chinese Medicine.

[0087] The main symptoms are:

[0088] Paroxysmal hot flashes, hot sensation and sweating on the head and face.

[0089] Feeling irritable, suspicious, or anxious.

[0090] Dizziness, tinnitus, insomnia and nightmares.

[0091] Palpitations and abnormal mood.

[0092] Menstrual disorders, irregular cycles, duration and menstrual volume.

[0093] Decreased libido and dry and atrophic vulva.

[0094] (e) Refer to the diagnostic criteria of kidney yin and yang deficiency syndrome in Traditional Chinese Medicine.

[0095] Symptoms of kidney yin and yang deficiency syndrome (refer to the "Terms of Clinical Diagnosis and Treatment of Traditional Chinese Medicine" issued by the State Bureau of Technical Supervision, national standard GB / T16751.2-1997).

[0096] Main symptoms: alternating chills and fever, hot sweats, soreness in waist and knees.

[0097] Secondary symptoms: dizziness, tinnitus, forgetfulness, cold pain in the waist and back, insomnia and nightmares, tooth loss and loose hair, oligomenorrhea and amenorrhea, hot flashes and night sweats, dry mouth and throat, fever in the five parts of the body, pale tongue, thin tongue coating, and weak pulse.

[0098] The diagnosis can be confirmed if two main symptoms and at least two secondary symptoms are present.

[0099] 3) Inclusion criteria

[0100] (a) Inclusion criteria:

[0101] ①Women aged 40 to 60 (inclusive);

[0102] ② Autonomic nervous system changes (hot flashes, night sweats, insomnia, irritability, etc., or one or more of these symptoms) and menstrual disorders (≥2 changes in the length of adjacent menstrual cycles >7 days within 10 months);

[0103] ③ The domestic modified Kupperman score is greater than 15 points;

[0104] ④ Symptoms of Kidney Yin and Yang Deficiency in Traditional Chinese Medicine: Primary symptoms: hot flashes, sweating, alternating hot and cold spells, soreness of the waist and knees; Secondary symptoms: dizziness, tinnitus, forgetfulness, cold pain in the waist and back, insomnia, frequent dreams, tooth loss and loose hair, oligomenorrhea, amenorrhea, hot flashes, night sweats, dry mouth and throat, fever in the five parts of the body, pale tongue, thin fur, and weak pulse. Two of the primary symptoms and at least two of the secondary symptoms are present.

[0105] ⑤ Those who signed the informed consent form.

[0106] Those who meet all five of the above conditions can be included in the group.

[0107] (b) Exclusion criteria

[0108] ① Uterine fibroids > 3 cm, or adenomyosis, or endometriosis, or bilateral oophorectomy, or severe breast hyperplasia, or reproductive system malignant tumors;

[0109] ② Patients with unexplained irregular vaginal bleeding that has not been cured;

[0110] ③ Patients with serious primary diseases of cardiovascular, cerebrovascular, liver, kidney, endocrine and hematopoietic systems or mental illness;

[0111] ④ Those who have used sex hormone drugs in the past 3 months;

[0112] ⑤ Those with conditions that affect oral drug absorption (e.g., gastrectomy);

[0113] ⑥Patients with allergic constitution;

[0114] ⑦ Those who have used antibiotics in the past 2 weeks.

[0115] If any of the above conditions are met, the applicant will be excluded.

[0116] 4) Grouping

[0117] The enrolled patients were randomly divided into a control group and a treatment group of 44 patients each. The control group was given oral Climen (estradiol valerate tablets / estradiol cyproterone acetate tablets), taking white tablets (containing 2 mg of estradiol valerate) for the first 11 days and light orange-red tablets (containing 2 mg of estradiol valerate and 1 mg of cyproterone acetate) for the next 10 days, one tablet per day, one hour after breakfast.

[0118] The treatment group was orally administered the Chinese medicine composition provided in Example 1 of the present invention, which was uniformly decocted and distributed by the First Affiliated Hospital of Guangzhou University of Chinese Medicine (called Guixian Mixture), one dose per day, 1 hour after breakfast.

[0119] (2) Treatment course

[0120] One course of treatment is 21 days of continuous medication, followed by 7 days of discontinuation (treatment interruption period), for a total of 3 courses of treatment.

[0121] (3) Observation items and testing time points

[0122] ① Baseline data collection: menopausal status, number of births, number of miscarriages, education level, marital status, body mass index, waist-to-hip ratio, etc.

[0123] ②Main efficacy indicator: modified Kupperman Index score (KI score)

[0124] ③Safety evaluation indicators: blood routine, liver function, kidney function, urine composition, electrocardiogram, breast color Doppler ultrasound and uterine adnexa color Doppler ultrasound.

[0125] Note: KI score, blood routine, liver function, and kidney function tests were performed within 7 days before the first dose, within 7 days after the first course of treatment, and within 7 days after the third course of treatment, for a total of 3 scores. Urine combination, electrocardiogram, breast ultrasound, and uterine adnexa ultrasound were performed within 7 days before the first dose of treatment and within 7 days after the third course of treatment, for a total of 2 tests. The test time points are as described in Table 1:

[0126] Table 1 Detection time points of different observation items

[0127]

[0128] Note: “-” in the table means that the item does not exist.

[0129] (4) Efficacy and safety evaluation standards

[0130] 1) Clinical efficacy evaluation criteria

[0131] Refer to the "Guidelines for Clinical Research on New Traditional Chinese Medicines for the Treatment of Menopausal Syndrome in Women" formulated and issued in 1997.

[0132] ① Recovery: Clinical symptoms disappear and physical and chemical examination results return to corresponding levels.

[0133] ② Markedly effective: Symptoms improved significantly, and physical and chemical examination results basically returned to the corresponding level.

[0134] ③Effective: Symptoms have improved and physical and chemical examination results have improved.

[0135] ④ Ineffective: Symptoms, signs, and physical and chemical indicators did not improve or worsened.

[0136] 2) Symptom improvement assessment criteria

[0137] The Kupperman Index, a domestically modified scoring method, was used to compare the changes in scores before and after treatment between and within the groups to assess the degree of symptom improvement. The total score was the sum of all symptom scores.

[0138] Modified Kupperman Index score: Perimenopause index score = basic score × severity score

[0139] Therapeutic index (n) = (score before treatment - score after treatment) ÷ score before treatment × 100%

[0140] ① Symptom efficacy evaluation criteria:

[0141] Recovery: clinical symptoms disappear, n ≥ 90%

[0142] Markedly effective: clinical symptoms improved significantly, 70≤n<90%

[0143] Effective: Clinical symptoms improved, 30%≤n<70%

[0144] Ineffective: No significant changes in clinical symptoms before and after treatment, n<30%

[0145] Disease severity: mild: 15-20 points; moderate: 21-35 points; severe: >35 points.

[0146] Scoring method: The symptom severity is multiplied by the symptom index, and the total score ranges from 0 to 63 points.

[0147] ②Symptom index:

[0148] Hot flashes and sweating: 4;

[0149] Paresthesia, insomnia, irritability, dyspareunia, urinary symptoms: 2;

[0150] Other symptoms: 1.

[0151] The severity of symptoms is divided into 0 to 3 points: no symptoms, 0 points; occasional symptoms, 1 point; symptoms that continue, 2 points; and symptoms that affect life, 3 points.

[0152] 3) Criteria for determining efficacy of TCM

[0153] ① Clinical recovery: The clinical symptoms of kidney yin and yang deficiency disappear, the physical signs disappear or basically disappear, and the symptom score decreases by ≥95%.

[0154] ② Markedly effective: The clinical symptoms and signs of kidney yin and yang deficiency syndrome were significantly improved, and the symptom score was reduced by ≥70%.

[0155] ③Effective: The clinical symptoms and signs of kidney yin and yang deficiency syndrome are improved, and the symptom score is reduced by ≥30%.

[0156] ④ Ineffective: The clinical symptoms and signs of kidney yin and yang deficiency syndrome have no obvious improvement or even worsen, and the symptom score is reduced by less than 30%.

[0157] Note: The calculation formula (nimodipine method) is: ﹛(score before treatment - score after treatment) ÷ score before treatment﹜×100%.

[0158] (3) Other indicators

[0159] Blood routine and liver and kidney function tests were analyzed according to the normal range of our hospital. Breast ultrasound and uterine adnexa color Doppler ultrasound were analyzed based on the results of B-ultrasound.

[0160] 2. Results

[0161] This study enrolled 100 patients with menopausal syndrome, with 50 in the experimental group and 50 in the control group. One patient in the control group was excluded. During treatment, 10 patients in the experimental group and 9 in the control group dropped out, resulting in a total of 40 patients in the experimental group and 40 patients in the control group. Therefore, the full analysis set for statistical analysis included 50 patients in the experimental group and 49 patients in the control group, and the per-protocol set included 40 patients in the experimental group and 40 patients in the control group.

[0162] (1) Baseline data

[0163] Per-protocol set (PP): The baseline data of the two groups were balanced and there was no statistical difference (P>0.05). Menopausal status, number of births, number of miscarriages, education level, and marital status were count data, and the chi-square test was used. 2 Waist-to-hip ratio was normally distributed, and the t-test was used. Body mass index was not normally distributed, and the Mann-Whitney rank sum test was used. Baseline data, test statistics, and P values for the two groups are shown in Table 2.

[0164] Table 2 Baseline data of the two groups of patients before taking medication (PP)

[0165]

[0166] Note: Enumeration data are expressed as the number of cases (%), using the χ 2 Test. The measurement data that conform to normal distribution are expressed as mean ± standard deviation. t-test was used for the data. Quantitative data that did not conform to the normal distribution were represented by M(Q1, Q3) and the Mann-Whitney rank sum test was used. "-" in the table indicates that the item was not available.

[0167] The full analysis set (FAS) showed that the baseline data of the two groups were balanced and there was no statistical difference (P>0.05). Menopausal status, number of births, number of miscarriages, education level, and marital status were count data, and the chi-square test was used. 2 Waist-to-hip ratio was normally distributed, and the t-test was used. Body mass index was not normally distributed, and the Mann-Whitney rank sum test was used. Baseline data, test statistics, and P values for the two groups are shown in Table 3.

[0168] Table 3 Baseline data of the two groups of patients before taking medication (FAS)

[0169]

[0170] Note: Enumeration data are expressed as the number of cases (%), using the χ 2 Test. The measurement data that conform to normal distribution are expressed as mean ± standard deviation. t-test was used for the data. Quantitative data that did not conform to the normal distribution were represented by M(Q1, Q3) and the Mann-Whitney rank sum test was used. "-" in the table indicates that the item was not available.

[0171] 3. Main analysis results and inferences

[0172] (1) KI scoring

[0173] Per-protocol set (PP): Paired t-tests compared the pre- and post-treatment KI scores within the two groups (see Table 4) and showed statistically significant differences (P < 0.05), indicating that both the experimental and control groups significantly reduced KI scores after treatment compared with pre-treatment. T-tests compared the pre- and post-treatment KI scores between the two groups and the difference in KI scores between the two groups showed no statistically significant differences (P > 0.05), indicating that the two groups were well-balanced before treatment and that there was no significant difference in the efficacy of the experimental group in improving KI scores after treatment. A non-inferiority test of the pre- and post-treatment KI scores between the two groups (see Table 5) showed that the efficacy of the experimental group in improving KI scores was no less than that of the control group (P < 0.05).

[0174] Table 4 Comparison of KI scores before and after treatment between the two groups [points, ](PP)

[0175] Group Before treatment After treatment Difference t○ P○ Experimental group (n=40) 23.48±5.52 9.57±4.30 -13.90±4.96 17.723 ＜0.001* Control group (n=40) 22.44±5.41 8.11±4.32 14.33±5.57 15.453 ＜0.001* t# 0.821 1.479 -0.359 - - P# 0.414 0.143 0.721 - -

[0176] Note: Difference is the difference in KI scores before and after treatment within the same group. ○ indicates a pre- and post-treatment comparison within the same group, using a paired t-test. # indicates a t-test between the experimental and control groups. * indicates P < 0.05. "-" indicates that the item is not available in the table.

[0177] Table 5 Non-inferiority test of KI scores before and after treatment in the two groups [scores, ](PP)

[0178]

[0179] Note: The difference is the difference in KI scores before and after treatment within the same group. * indicates P < 0.05.

[0180] Full Analysis Set (FAS): Paired t-tests compared the pre- and post-treatment KI scores within the two groups (see Table 6) and showed statistically significant differences (P < 0.05), indicating that both the experimental and control groups significantly reduced KI scores after treatment compared with pre-treatment. T-tests compared the pre- and post-treatment KI scores between the two groups and the difference in KI scores between the two groups showed no statistically significant differences (P > 0.05), indicating that the two groups were well-balanced before treatment and that there was no significant difference in the KI score improvement between the experimental group and the control group after treatment. A non-inferiority test of the pre- and post-treatment KI scores between the two groups (see Table 7) showed that the experimental group was not inferior to the control group in improving KI scores (P > 0.05).

[0181] Table 6 Comparison of KI scores before and after treatment between the two groups [scores, (X±S)] (FAS)

[0182] Group Before treatment After treatment Difference t○ P○ Experimental group (n=50) 22.36±5.42 12.32±6.51 11.43±7.71 8.380 ＜0.001* Control group (n=49) 23.16±5.87 11.73±8.32 10.04±7.02 7.859 ＜0.001* t# 0.708 -0.390 0.938 - - P# 0.481 0.697 0.351 - -

[0183] Note: Difference is the difference in KI scores before and after treatment within the same group. ○ indicates a pre- and post-treatment comparison within the same group, using a paired t-test. # indicates a t-test between the experimental and control groups. * indicates P < 0.05. "-" indicates that the item is not available in the table.

[0184] Table 7 Non-inferiority test of KI scores before and after treatment in the two groups [scores, (X±S)] (FAS)

[0185]

[0186] Note: The difference is the difference in KI scores before and after treatment within the same group.

[0187] (2) Three sex hormones

[0188] Per-Protocol Set (PP): The Wilcoxon rank sum test compared the three sex hormone levels (FSH, LH, and E2) before and after treatment between the two groups (see Tables 8-10). There was no statistical difference in the experimental group (P>0.05), while there was a statistical difference in the control group (P<0.05). This indicates that compared with pre-treatment, the control group had a significant improvement in sex hormone levels after treatment, while the experimental group had no significant improvement in sex hormone levels after treatment. The Mann-Whitney rank sum test showed no statistical difference between the two groups before treatment (P>0.05), indicating that the two groups were well-balanced before treatment. After treatment, the difference between the two groups was statistically significant (P<0.05), indicating that the control group can significantly reduce FSH and LH levels and increase E2 levels in patients with menopausal syndrome.

[0189] Table 8 Comparison of FSH before and after treatment between the two groups [IU / L, M (Q1, Q3)] (PP)

[0190] Group Before treatment After treatment Difference <![CDATA[Z ○ ]]> <![CDATA[P ○ ]]> Experimental group (n=40) 70.47(57.58，91.80) 71.19(53.54，87.00) -0.49(-7.92，11.65) -0.265 0.791 Control group (n=40) 67.99(59.87，91.11) 36.37(12.08，51.64) 36.66(10.42，51.12) -4.776 ＜0.001* Z# -0.317 -3.475 -4.676 - - P# 0.751 0.001* ＜0.001* - -

[0191] Note: Differences are the differences in FSH values before and after treatment within the same group. ○ indicates a pre- and post-treatment comparison within the same group, using the Wilcoxon rank sum test. # indicates a comparison between the experimental and control groups, using the Mann-Whitney rank sum test. * indicates P < 0.05. "-" indicates that the item is not available in the table.

[0192] Table 9 Comparison of LH before and after treatment between the two groups [IU / L, M (Q1, Q3)] (PP)

[0193] Group Before treatment After treatment Difference <![CDATA[Z ○ ]]> <![CDATA[P ○ ]]> Experimental group (n=40) 37.39(28.33，54.32) 36.20(27.55，55.47) 0.14(-4.66，3.34) -0.181 0.856 Control group (n=40) 38.66(30.02，52.59) 14.94(8.97，35.80) 17.05(4.61，28.23) -4.231 ＜0.001* Z# -0.011 -3.612 -4.024 - - P# 0.991 ＜0.001* ＜0.001* - -

[0194] Note: Two patients in the control group had missing pre-treatment LH values, so n = 34. Difference is the difference between pre- and post-treatment LSH values. ○ indicates a pre- and post-treatment comparison within the same group, using the Wilcoxon rank sum test. # indicates a between-group comparison between the experimental and control groups, using the Mann-Whitney rank sum test. * indicates P < 0.05. "-" indicates that the item is not available in the table.

[0195] Table 10 Comparison of E2 before and after treatment between the two groups [pmol / L, M (Q1, Q3)] (PP)

[0196]

[0197]

[0198] Note: Some E2 values before and after treatment are missing in both groups; n = 30 for the experimental group and n = 28 for the control group. Differences are the differences in E2 values before and after treatment within the same group. ○ indicates a pre-treatment comparison within the same group, using the Wilcoxon rank sum test. # indicates a between-group comparison between the experimental and control groups, using the Mann-Whitney rank sum test. * indicates P < 0.05. "-" indicates that the item is not available in the table.

[0199] Full Analysis Set (FAS): The Wilcoxon rank sum test compared the three sex hormone levels (FSH, LH, and E2) before and after treatment between the two groups (see Tables 11-13). No statistical difference was found in the experimental group (P>0.05), while there was a statistical difference in the control group (P<0.05). This indicates that compared with pre-treatment, the control group had a significant improvement in sex hormone levels after treatment, while the experimental group had no significant improvement in sex hormone levels after treatment. The Mann-Whitney rank sum test showed no statistical difference between the two groups before treatment (P>0.05), indicating that the two groups were well-balanced before treatment. After treatment, the difference between the two groups was statistically significant (P<0.05), indicating that the control group can significantly reduce FSH and LH levels and increase E2 levels in patients with menopausal syndrome.

[0200] Table 11 Comparison of FSH before and after treatment between the two groups [IU / L, M (Q1, Q3)] (FAS)

[0201] Group Before treatment After treatment Difference <![CDATA[Z ○ ]]> <![CDATA[P ○ ]]> Experimental group (n=50) 68.43(52.31，93.66) 73.20(54.56，89.04) -0.52(-7.95，10.65) -0.365 0.771 Control group (n=49) 67.72(53.87，92.01) 37.37(11.15，50.64) 37.45(10.41，52.15) -4.706 ＜0.001* Z# -0.256 -4.570 -3.604 - - P# 0.736 0.001* ＜0.001* - -

[0202] Note: Differences are the differences in FSH values before and after treatment within the same group. ○ indicates a pre- and post-treatment comparison within the same group, using the Wilcoxon rank sum test. # indicates a comparison between the experimental and control groups, using the Mann-Whitney rank sum test. * indicates P < 0.05. "-" indicates that the item is not available in the table.

[0203] Table 12 Comparison of LH before and after treatment between the two groups [IU / L, M (Q1, Q3)] (FAS)

[0204] Group Before treatment After treatment Difference <![CDATA[Z ○ ]]> <![CDATA[P ○ ]]> Experimental group (n=50) 38.10(28.33，53.32) 36.20(27.55，55.47) 0.15(-4.77，4.34) -0.181 0.868 Control group (n=49) 38.66(30.01，54.59) 14.94(8.97，35.80) 17.05(5.23，28.68) -4.253 ＜0.001* Z# -0.012 -3.520 -3.021 - - P# 0.792 ＜0.001* ＜0.001* - -

[0205] Note: Difference is the difference in LSH before and after treatment. ○ indicates intra-group comparison before and after treatment, using the Wilcoxon rank sum test. # indicates inter-group comparison between the experimental and control groups, using the Mann-Whitney rank sum test. * indicates P < 0.05. "-" indicates that the item is not available in the table.

[0206] Table 13 Comparison of E2 before and after treatment between the two groups [pmol / L, M (Q1, Q3)] (FAS)

[0207] Group Before treatment After treatment Difference <![CDATA[Z ○ ]]> <![CDATA[P ○ ]]> Experimental group (n=50) 52.58(42.61，151.26) 66.52(44.55，149.00) -4.34(-43.00，16.49) -0.592 0.554 Control group (n=49) 58.72(39.08，85.13) 209.20(58.03，590.68) -93.82(-531.55，-10.73) -3.301 0.001* Z# -0.607 -2.412 -1.712 - - P# 0.544 0.016* 0.048* - -

[0208] Note: Differences are the differences in E2 before and after treatment within the same group. ○ indicates a pre- and post-treatment comparison within the same group, using the Wilcoxon rank sum test. # indicates a comparison between the experimental and control groups, using the Mann-Whitney rank sum test. * indicates P < 0.05. "-" indicates that the item is not available in the table.

[0209] (3) Adverse events (all adverse events that occurred during the study and detailed treatment process)

[0210] In this trial, there were no serious adverse events and 19 adverse events. A total of 4 patients in the experimental group experienced adverse reactions before and after treatment, including 3 with mild epigastric distension and pain (all 3 continued to take the medication for observation, and the symptoms gradually subsided after the patient was instructed to take small, repeated doses of warm Chinese herbal decoction). One patient developed loose stools and mild abdominal distension and pain (the patient requested discontinuation of the treatment after the symptoms did not subside despite repeated doses of warm Chinese herbal decoction). The remaining subjects showed no significant abnormalities in blood analysis, urine composition, liver and kidney function, electrocardiogram, uterine adnexa color Doppler ultrasound, or breast color Doppler ultrasound. A total of 15 patients in the control group experienced adverse reactions before and after treatment, including 8 with irregular vaginal bleeding (7 resolved after continued medication observation, and 1 was lost to follow-up), 1 with palpitations (the patient requested discontinuation), 1 with dry mouth (the patient continued medication observation and was advised to drink plenty of water), 1 with headache (the patient requested discontinuation), 2 with enlarged breast nodules (one patient completed the course of treatment and was reexamined and advised to consult a breast specialist; the other patient requested discontinuation), 1 with epigastric distension and pain during treatment (gradually alleviated after continued medication observation), and 1 with mild elevations in creatinine and urea (elevated levels after completion of the course of treatment; the patient was advised to reexamine 1 week later). No significant abnormalities were found in the remaining subjects' blood analysis, urine composition, liver and kidney function, electrocardiogram, uterine adnexa color Doppler ultrasound, or breast color Doppler ultrasound. Adverse events were recorded on the CRF form. Once the subject reported the adverse event to the researcher, the treatment of the subject was determined and the adverse reaction was recorded. Changes in adverse reactions were monitored continuously after treatment. The incidence of adverse reactions in patients with perimenopausal syndrome after treatment was compared using the chi-square test. 2 Test (see Table 14), χ 2 =8.159, P=0.004<0.05, the difference in the incidence of adverse reactions between the two groups was statistically significant, indicating that the incidence of adverse reactions in the experimental group was lower than that in the positive control group.

[0211] Table 14 Incidence of adverse reactions in the two groups [cases (%)]

[0212]

[0213] Note: Chi-square test, *P<0.05.

[0214] The technical features of the above-described embodiments can be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0215] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

Claims

1. A Chinese medicine composition for treating menopausal syndrome, characterized in that: The invention is prepared from the following raw materials in parts by weight: 5-10 parts of Curculigo orchioides, 5-10 parts of Epimedium, 15-30 parts of Morinda officinalis, 10-20 parts of Chinese angelica, 5-10 parts of Anemarrhena asphodeloides, 5-10 parts of Phellodendron chinense, 60-100 parts of raw oyster, 30-50 parts of tortoise shell, 10-20 parts of cinnamon twig, 10-20 parts of white peony root, 10-20 parts of roasted liquorice root, 10-20 parts of jujube and 10-20 parts of ginger.

2. The Chinese medicine composition according to claim 1, wherein The invention is prepared from the following raw materials in parts by weight: 5-9 parts of Curculigo orchioides, 5-9 parts of Epimedium, 15-25 parts of Morinda officinalis, 10-19 parts of Chinese angelica, 5-9 parts of Anemarrhena asphodeloides, 5-9 parts of Phellodendron amurense, 60-90 parts of raw oyster, 30-45 parts of tortoise shell, 10-18 parts of cinnamon twig, 10-19 parts of white peony root, 10-19 parts of roasted liquorice root, 10-18 parts of jujube and 10-15 parts of ginger.

3. The Chinese medicine composition according to claim 2, wherein The invention is prepared from the following raw materials in parts by weight: 5-7 parts of Curculigo orchioides, 5-7 parts of Epimedium, 15-18 parts of Morinda officinalis, 10-13 parts of Chinese angelica, 5-6 parts of Anemarrhena asphodeloides, 5-6 parts of Phellodendron chinense, 60-70 parts of raw oyster, 30-35 parts of tortoise shell, 10-13 parts of cinnamon twig, 10-15 parts of white peony root, 10-15 parts of roasted liquorice root, 10-15 parts of jujube and 10-12 parts of ginger.

4. The method for preparing the Chinese medicine composition according to any one of claims 1 to 3, wherein: include: Weigh curculigo, epimedium, Morinda officinalis, angelica, anemarrhena, phellodendron, raw oyster, tortoise shell, cinnamon twig, white peony root, roasted liquorice root, jujube and ginger according to the proportion and extract with water to obtain the product.

5. The preparation method according to claim 4, wherein The amount of water is 5 to 7 times the amount of the raw material medicine in the traditional Chinese medicine composition.

6. The preparation method according to claim 4, wherein The extraction method is selected from any one of a decoction method, a water heating reflux method or an ultrasonic extraction method.

7. A drug for treating menopausal syndrome, characterized in that: The medicine uses the traditional Chinese medicine composition according to any one of claims 1 to 3 as an active ingredient.

8. The drug according to claim 7, wherein The drug also includes pharmaceutically acceptable excipients.

9. The drug according to claim 7, wherein The dosage form of the medicine is decoction, granules, pills, capsules, tablets, powders or oral liquid.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating menopausal syndrome.

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