Application of valerian extract in preparation of medicine for preventing and treating climacteric syndrome

Abstract

The invention belongs to the field of traditional Chinese medicines, and provides application of a valerian extract in preparation of a medicine for preventing and treating climacteric syndrome. Pharmacological experiments show that the valerian extract has a regulation effect on a hypothalamic-pituitary-neuroendocrine system, and has important significance in regulating postmenopausal endocrine conditions of middle-aged and old women and improving anxiety, insomnia, dysphoria and other climacteric symptoms related to FSH (follicle stimulating hormone) and LH (luteinizing hormone). In addition, the valerian extract has a good regulation effect on secretion of related sex hormones and hypothalamus neurotransmitters of climacteric rats, and has a certain correction effect on the central monoamine neurotransmitter disorder state of the climacteric rats. The traditional Chinese medicine composition can improve clinical symptoms of climacteric syndrome.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to the use of a valerian extract in the preparation of a drug for the prevention and treatment of menopausal syndrome. Background Technology

[0002] Menopause is the transitional stage in a woman's life from reproductive capacity to non-reproductive capacity. During this stage, women experience menstrual changes such as frequent menstruation, scanty menstruation, irregular menstruation, and amenorrhea. Simultaneously, changes in ovarian endocrine function during menopause lead to changes in the internal environment, affecting the function of various organ systems and causing corresponding symptoms. These include hot flashes, sweating, headaches (symptoms of vasomotor instability), palpitations, dizziness, insomnia, abnormal skin sensations (symptoms of autonomic nervous system instability), and psychological symptoms such as depression, anxiety, paranoia, decreased self-confidence, poor concentration, irritability, phobias, and even hysterical-like symptoms, collectively known as menopausal syndrome.

[0003] Causes of Menopausal Syndrome: Ovarian dysfunction is the main contributing factor. It initially manifests as progressive luteal regression or absence of corpus luteum formation, leading to fewer ovulation cycles and eventually anovulation. Estrogen secretion also gradually decreases until it is insufficient to stimulate the endometrium, resulting in scanty or absent menstruation. Due to the reduced estrogen and progesterone secretion by the ovaries, blood levels decrease, altering the normal balance of the hypothalamic-pituitary-ovarian axis. The feedback inhibition of estrogen on the pituitary gland weakens, leading to hypothalamic-pituitary hyperfunction, manifested as increased secretion of gonadotropins such as follicle-stimulating hormone (FSH) and luteinizing hormone (LH). This endocrine change affects the central nervous system and the functions of its controlled organs, resulting in a series of symptoms of autonomic nervous system dysfunction. Women with pre-existing autonomic nervous system instability are most susceptible, and the condition is also related to personality, psychological factors, and social and cultural environmental factors.

[0004] Clinical symptoms of menopausal syndrome include: 1) Cardiovascular symptoms: Hot flashes are often the first symptom, followed by sweating, chills, or alternating hot and cold sensations, lasting from a few seconds to a few minutes. Sometimes accompanied by palpitations, anxiety, "pseudo-angina," chest tightness, dizziness, headache, heaviness in the head, head distension, and elevated blood pressure. 2) Neuropsychiatric symptoms: Mood instability, depression, anxiety, irritability, mood changes, depression and anxiety, memory decline, poor concentration, insomnia, fatigue, and numbness in the limbs. 3) Changes in the menstrual and reproductive systems: Menstrual irregularities, often with prolonged cycles, gradually decreasing menstrual flow, or even amenorrhea; or shortened cycles and increased menstrual flow; or irregular cycles and menstrual flow; gradual atrophy of the vulva and vagina or itching. 4) Joint, skin, and muscle symptoms, such as joint pain, lower back pain, muscle pain, and abnormal skin sensations.

[0005] Valerian is the dried rhizome and root of *Valeriana pseudofcinalis* CYCheng et HHChen, a plant in the Valerianaceae family. It is pungent, sweet, and warm in nature. It enters the heart and liver meridians. Its functions and indications include calming the mind, regulating qi, and relieving pain. It is used for restlessness, palpitations, insomnia, depression, epilepsy, abdominal distension and pain, lower back and leg pain, and traumatic injuries. Valerian is sweet in taste and primarily enters the heart and liver meridians. It has calming, qi-regulating, and depression-relieving effects, treating restlessness, palpitations, depression, and epilepsy. Modern pharmacological experiments have shown that it has sedative, antidepressant, anti-anxiety, anti-epileptic, anticonvulsant, memory-improving, and anti-cerebral ischemia-related central nervous system effects. It also has antiarrhythmic, lipid-lowering, and kidney-protective pharmacological effects. There are no reports in existing literature regarding the use of valerian for the prevention and improvement of menopausal syndrome symptoms. Summary of the Invention

[0006] In view of the above-mentioned prior art, through long-term technical and practical exploration, the present invention provides the use of valerian extract in the preparation of a drug for the prevention and treatment of menopausal syndrome.

[0007] This invention is achieved through the following technical solution: This invention provides the use of valerian extract in the preparation of a medicament for the prevention and treatment of menopausal syndrome, specifically the use of the valerian extract in the preparation of a medicament for the prevention and treatment of estrogen deficiency menopausal syndrome.

[0008] Preferably, the use of the valerian extract in the preparation of health products for the prevention of menopausal syndrome caused by estrogen deficiency.

[0009] As a further explanation of the present invention, the drug is prepared into various oral preparations using valerian herbal materials or valerian extract as raw materials according to conventional preparation methods. The oral preparations are powders, granules, microcapsules, soft capsules, tablets or oral liquids.

[0010] Preferably, the method for preparing the valerian extract involves extracting the effective components of valerian using supercritical carbon dioxide extraction at an extraction temperature below 40°C. Specifically, the method includes the following steps: taking coarse valerian powder, employing supercritical carbon dioxide extraction technology at an extraction temperature of 30–40°C, an extraction pressure of 20–30 MPa, and using an entrainer at a volume of 2–4 times the weight of the herb. The entrainer is measured in ml, and the herb weight is measured in g. The entrainer is selected from methanol, anhydrous ethanol, or 95% ethanol. The desorption temperature is 30–40°C, the desorption pressure is 3–6 MPa, the CO2 flow rate is 10–20 L / h, and the extraction time is 1–2 h.

[0011] As a further explanation of the present invention, the drug is prepared by mixing and grinding valerian volatile oil inclusions and extract powder. Preferably, the valerian preparation is prepared by mixing and grinding valerian volatile oil inclusions and extract powder. Furthermore, the preparation method of the valerian preparation includes the following steps: 1) Fresh valerian rhizomes and roots are used. After washing away the dirt and draining, they are chopped into 1-5cm long pieces and then distilled using a water-double-barrel pressurized direct steam distillation method. The initial steam pressure is 0.08-0.12mPa / cm². 2 During the distillation process, the steam pressure was 0.02-0.06 mPa / cm. 2 The steam pressure in the later stage of distillation is 0.08-0.10 mPa / cm. 2 The process lasts for 1.5-2.5 hours, during which volatile oil and medicinal residue are separated. 2) The dregs are dried in advance, either by sun drying, oven drying, or vacuum drying. They are then placed in a percolation tank and compacted. After soaking in 70-95% v / v ethanol (1.5 times the amount of fresh medicinal material) for 8-12 hours, percolation begins. The percolate is filtered, the ethanol is recovered, concentrated, and dried to obtain valerian dry extract. The extract is then ground and sieved to obtain valerian extract powder. 3) Take 2-5 times the weight of β-cyclodextrin of volatile oil, add 1-2 times the amount of distilled water and grind evenly. Then add valerian volatile oil and grind thoroughly for 20-40 minutes to form a volatile oil mixture. Filter to remove water, wash away the un-encapsulated volatile oil with petroleum ether at a boiling range of 30-60℃, and dry at room temperature, air dry, or vacuum dry. Grind and sieve to obtain valerian volatile oil β-cyclodextrin inclusion powder. 4) The β-cyclodextrin inclusion complex powder of valerian volatile oil is mixed with valerian extract powder and starch is added to the filler volume. After mixing evenly, the mixture is passed through a 38-45 mesh sieve and then filled into capsules to make capsules.

[0012] Specifically, the above-mentioned valerian preparations are made from the following raw materials in parts by weight: raw material weight Valerian volatile oil 65-68mg β-Cyclodextrin 195-264mg Valerian extract powder 24-30mg Medicinal starch 18-24mg 70% ethanol 28-32mg magnesium stearate 0.6-0.7mg talcum powder 0.3-0.4mg .

[0013] More preferably, the valerian preparation is made from the following raw materials in parts by weight: raw material weight Valerian volatile oil 66-68mg β-Cyclodextrin 198-206mg Valerian extract powder 26-28mg Medicinal starch 20-22mg 70% ethanol 29-30mg magnesium stearate 0.6-0.65mg talcum powder 0.3-0.35mg ; The valerian volatile oil is a pale yellow clear liquid with a fragrant aroma and a slightly pungent taste. It has a relative density of 0.94-0.96, a refractive index of 1.48-1.49, a heavy metal content of no more than 10 parts per million, and a bornyl acetate content of ≥ 27%. The valerian extract powder is a brownish-brown powder with a moisture content of <5%, a valerian terpene lactone A content of ≥1.3%, and a total terpene lactone content of ≥8.0%. Each capsule contains 0.29g and contains ≥40mg of valerian volatile oil, 25±3mg of valerian extract, >12mg of bornyl acetate, >0.38mg of valerian lactone A, and >5.5mg of total terpene lactones.

[0014] Furthermore, the valerian preparation is Rick® Valerian Extract Capsules produced by Wuhan United Pharmaceutical Co., Ltd.

[0015] In this invention, the non-pharmaceutical active ingredients such as carriers, excipients, and diluents that may be included are well known in the art, and those skilled in the art can determine that they meet clinical standards.

[0016] The beneficial effects of this invention are: This invention provides the use of valerian preparations in the prevention and treatment of menopausal syndrome. Pharmacological experiments show that valerian extract has a regulatory effect on the hypothalamic-pituitary-neuroendocrine system, which is of great significance for regulating the endocrine status of postmenopausal women and improving menopausal symptoms such as anxiety, insomnia, and irritability related to FSH and LH. In addition, valerian extract has a good regulatory effect on the secretion of hormones related to menopause and hypothalamic neurotransmitters in menopausal rats, and has a certain corrective effect on the disordered state of central monoamine neurotransmitters in menopausal rats. This invention can improve the clinical symptoms of menopausal syndrome. Detailed Implementation

[0017] The present invention will be further illustrated with specific examples. These examples are for illustrative purposes only and do not limit the scope of the invention. Unless otherwise specified, experimental conditions not explicitly stated in the examples are generally performed under conventional conditions or as recommended by the reagent company. Unless otherwise specified, all reagents and consumables used in the following examples are commercially available.

[0018] The following examples further illustrate the present invention, but do not constitute a limitation thereof. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the invention.

[0019] Example 1. Preparation of a valerian preparation The valerian preparation is made from the following raw materials in parts by weight: raw material weight Valerian volatile oil 66-68mg β-Cyclodextrin 198-206mg Valerian extract powder 26-28mg Medicinal starch 20-22mg 70% ethanol 29-30mg magnesium stearate 0.6-0.65mg talcum powder 0.3-0.35mg .

[0020] The method for preparing the valerian preparation comprises the following steps: 1) Fresh valerian rhizomes and roots are used. After washing away the dirt and draining, they are chopped into 1-5cm long pieces and then distilled using a water-double-barrel pressurized direct steam distillation method. The initial steam pressure is 0.08-0.12mPa / cm². 2During the distillation process, the steam pressure was 0.02-0.06 mPa / cm. 2 The steam pressure in the later stage of distillation is 0.08-0.10 mPa / cm. 2 The process lasts for 1.5-2.5 hours, during which volatile oil and medicinal residue are separated. 2) The dregs are dried in advance, either by sun drying, oven drying, or vacuum drying. They are then placed in a percolation tank and compacted. After soaking in 70-95% v / v ethanol (1.5 times the amount of fresh medicinal material) for 8-12 hours, percolation begins. The percolate is filtered, the ethanol is recovered, concentrated, and dried to obtain valerian dry extract. The extract is then ground and sieved to obtain valerian extract powder. 3) Take 2-5 times the weight of β-cyclodextrin of volatile oil, add 1-2 times the amount of distilled water and grind evenly. Then add valerian volatile oil and grind thoroughly for 20-40 minutes to form a volatile oil mixture. Filter to remove water, wash away the un-encapsulated volatile oil with petroleum ether at a boiling range of 30-60℃, and dry at room temperature, air dry, or vacuum dry. Grind and sieve to obtain valerian volatile oil β-cyclodextrin inclusion powder. 4) The β-cyclodextrin inclusion complex powder of valerian volatile oil is mixed with valerian extract powder and starch is added to the fill weight. After mixing evenly, the mixture is passed through a 38-45 mesh sieve and then filled into capsules to make capsules. The valerian volatile oil is a pale yellow clear liquid with a fragrant aroma and a slightly pungent taste. It has a relative density of 0.94-0.96, a refractive index of 1.48-1.49, a heavy metal content of no more than 10 parts per million, and a bornyl acetate content of ≥ 27%. The valerian extract powder is a brownish-brown powder with a moisture content of <5%, a valerian terpene lactone A content of ≥1.3%, and a total terpene lactone content of ≥8.0%. Each capsule contains 0.29g and contains ≥40mg of valerian volatile oil, 25±3mg of valerian extract, >12mg of bornyl acetate, >0.38mg of valerian lactone A, and >5.5mg of total terpene lactones.

[0021] Existing medicinal valerian preparations mainly include valerian powder, valerian extract, valerian tincture, and compound preparations. All are made from dried valerian as raw material, directly powdered or powdered and then extracted with low-to-medium concentration ethanol (60% or less). Preparations produced using existing techniques have extremely low valerian volatile oil content and low terpene lactone content. According to literature reports, the volatile oil content of valerian can decrease by 50% after six months of storage. Our observations show that the volatile oil content of fresh valerian from a certain region was 1.8%, but after two years of storage in a cool, shady indoor environment at high altitudes, the volatile oil content plummeted to 0.5%. Powdering the herb further significantly reduces the oil content. Secondly, valerian volatile oil is insoluble in low-to-medium concentration ethanol, and valerian terpene lactones are also poorly soluble in low-to-medium concentration ethanol. Therefore, valerian preparations made from dried valerian using low-to-medium concentration ethanol (60% or less) have extremely low valerian volatile oil and very low terpene lactone content. This invention utilizes the roots and rhizomes of fresh valerian. After rinsing to remove dirt and sand, draining, and slightly chopping (into 1-5cm pieces), the volatile oil is prepared using a water-double-barrel pressurized steam direct distillation method. During distillation, water is discarded from the distillation tank approximately every 1 / 2 hour, saving time and labor while achieving a high oil yield. The volatile oil extracted from fresh valerian is then encapsulated with β-cyclodextrin. This encapsulation process ensures stability, high encapsulation rate, significantly improving the stability of the formulation, accelerating absorption, and enhancing patient tolerance. Experiments show that the valerian volatile oil β-cyclodextrin-encapsulated compound, when placed in an open environment at 40℃ and 70% relative humidity for 90 days, exhibits a volatile oil loss rate of <5%. This minimizes the loss of volatile oil components, ensuring the stability and efficacy of the formulation.

[0022] Example 2. Preparation of a valerian preparation Preparation method of valerian extract: The effective components of valerian were extracted using supercritical carbon dioxide extraction at an extraction temperature below 40℃. The specific steps included: taking crude valerian powder, using supercritical carbon dioxide extraction technology, with an extraction temperature of 30-40℃, an extraction pressure of 20-30 MPa, and an entrainer amount of 2-4 times the weight of the herb. The entrainer amount is measured in ml, and the herb weight is measured in g. The entrainer is selected from methanol, anhydrous ethanol, or 95% ethanol. The desorption temperature was 30-40℃, the desorption pressure was 3-6 MPa, the CO2 flow rate was 10-20 L / h, and the extraction time was 1-2 h.

[0023] Valerian extract, whose active ingredients include valerin derivatives, valerenoic acid derivatives, and volatile oils. The obtained valerian extract is prepared into various oral formulations using conventional pharmaceutical methods. These oral formulations are powders, granules, microcapsules, soft capsules, tablets, or oral liquids.

[0024] Example 3. Pharmacological tests: The pharmacological activity and effective dosage of the drug were tested in menopausal animals to assess their endocrine disorders, reproductive system, and behavior. The results are reported below: 1. Effects on the uterus and estrogen levels in female SD rats Test drug: The control group used estradiol valerate, prepared as a suspension with corn oil. The sample group used valerian extract capsules produced by Wuhan United Pharmaceutical Co., Ltd., batch number 202401019.

[0025] Test animals: Ten-week-old female SD grade II rats, weighing 245 (±10g). They were divided into sham-operated group, model group, estradiol group, low-dose group, medium-dose group and high-dose group of the sample, with 12 rats in each group.

[0026] Modeling: Except for the sham-operated group, the abdomen of the rats was cut open along the midline, and both ovaries were removed. The suturing was then performed. The rats in the sham-operated group underwent the same surgical procedure, but the ovaries were not removed.

[0027] Administration method: After surgery, rats in each group were fed a normal diet for 2 weeks. Drug administration began in the 3rd week after surgery and continued for 5 weeks. The normal group, model group and sham-operated group were given the same volume of corn oil by gavage daily. The estradiol group was given 0.25 mg / (kg·day) of estradiol by gavage daily. The low-dose sample group was given 100 mg / (kg·day) by gavage. The medium-dose sample group was given 250 mg / (kg·day) by gavage. The high-dose sample group was given 500 mg / (kg·day) by gavage.

[0028] Experimental Results: Statistical Analysis: Data are expressed as mean ± standard deviation (mean ± s). Statistical analysis was performed using the t-test. P < 0.05 was considered statistically significant, and P < 0.01 was considered highly statistically significant.

[0029] 1) Effect on uterine weight in SD rats: Uterine wet weight observation: Five weeks after administration, each group was anesthetized, the midline of the abdomen was cut open, the uterus was completely separated from the surrounding tissues, and the uterus was weighed.

[0030] Table 1. Effects on uterine development in ovariectomized rats (means±s, n=12) Group Uterine weight (mg / 100g) Sham surgery group 279.21±15.64 Model group <![CDATA[132.54±13.12 ## ]]> estradiol group 201.32±56.24 Low-dose group of samples 162.08±34.15 In the sample, the dose group 185.55±15.38* High-dose group of samples 195.12±12.56* Note: Compared with the sham surgery group, ##p<0.01, #p<0.05; compared with the model group, **p<0.01, *p<0.05.

[0031] The results are shown in Table 1. Seven weeks after bilateral ovariectomy, the rat uterus significantly atrophied, and the uterine weight was significantly lower in the model group compared with the sham-operated group (P < 0.01). Five weeks after administration, the medium-dose and high-dose groups of the sample showed some recovery of the atrophied uterus (P < 0.05), while the low-dose group of the sample had no significant effect.

[0032] 2) Effects on serum estrogen levels in SD rats: Hormone assay: Five weeks after administration, each group was anesthetized, injected intraperitoneally, and blood was collected from the abdominal aorta. Serum was separated, stored at -20℃, and the levels of estradiol (E2), follicle-stimulating hormone (FSH), and luteinizing hormone (LH) in the serum were measured using radioimmunoassay.

[0033] Table 2. Effects of hormone levels on ovariectomized rat serum hormone levels (means±s, n=12) Group estradiol pg / ml Follicle-stimulating hormone mIU / ml Luteinizing hormone mIU / ml Sham surgery group 25.68±2.13 1.69±0.41 1.19±0.52 Model group <![CDATA[13.3±0.75 ## ]]> <![CDATA[3.35±0.37 ## ]]> <![CDATA[2.85±0.12 ## ]]> estradiol group 23.54±0.28 2.25±0.46 1.32±0.24 Low-dose group of samples 17.8±0.54 2.73±0.33 2.48±0.34 In the sample, the dose group 18.7±1.12* 2.52±0.52* 2.25±0.38* High-dose group of samples 19.8±1.36* 2.31±1.36* 1.52±0.16* Note: Compared with the sham surgery group. ## p < 0.01, # p < 0.05; compared with the model group, **p < 0.01, *p < 0.05 The results are shown in Table 2. After ovariectomy in rats, serum estradiol levels decreased significantly, with a significant difference between the model group and the sham-operated group (P < 0.01). At the same time, follicle-stimulating hormone (FSH) and luteinizing hormone (LH) levels increased significantly (P < 0.01). Estradiol treatment could restore serum estrogen levels. After gavage administration of medium and high doses of valerian extract, serum estrogen levels showed the same trend as the estradiol-treated group, with significantly increased estradiol levels (P < 0.01) and significantly decreased FSH and LH levels (FSH < 0.05, LH < 0.01).

[0034] 3) Effects on the levels of 5-HT, NE, and DA in rat hypothalamic tissue Table 3 Comparison of 5-HT, NE, and DA levels in the hypothalamus tissue of rats in different groups (n=12) Group 5-HTml NE DA Sham surgery group 1.28±0.13 1.89±0.24 2.62±0.52 Model group 2.83±0.35 1.55±0.17 0.72±0.18 estradiol group 1.54±0.18 1.95±0.12 1.52±0.24 Low-dose group of samples 1.78±0.25 1.83±0.13 1.46±0.16 In the sample, the dose group 1.62±0.22 1.86±0.15 1.75±0.38 High-dose group of samples 1.48±0.16 1.96±0.09 1.83±0.25 The results are shown in Table 3. After ovariectomy, compared with the control group, the 5-HT content in the hypothalamus of the model group was significantly increased, while the NE and DA content was significantly decreased (P < 0.01). After gavage administration, compared with the model group, the 5-HT content in the hypothalamus of each administration group was significantly decreased, while the NE and DA content was significantly increased (P < 0.01, P < 0.05). Compared with estradiol valerate tablets, there was basically no difference in the 5-HT, NE, and DA content in the hypothalamus of each administration group (P > 0.05).

[0035] Conclusion: Menopausal syndrome refers to a group of symptoms in women around the time of menopause, characterized primarily by autonomic nervous system dysfunction and accompanied by neuropsychological symptoms, caused by fluctuations or decreases in sex hormones. Menopausal syndrome occurs as women transition from reproductive age to old age, due to declining ovarian function, decreased sex hormone secretion, and increased gonadotropins, leading to a systemic imbalance in neuroendocrine function, particularly a disorder of the hypothalamic autonomic nervous system and hyperactivity of the sympathetic-adrenal system, resulting in a series of clinical signs. Uterine bioassay in rats has long been a classic method for studying the estrogenic activity of drugs. In the above experiment, after administering medium and high doses of the extract to ovariectomized SD rats by gavage for 5 weeks, the uterine weight, endometrial thickness, and number of glands in the endometrial basal layer of the SD rats were significantly increased, demonstrating an estrogen-like effect on the uterus. In addition, valerian extract significantly improved the secretion of estrogen in serum, with medium and high doses of valerian extract acting directly on the uterus and significantly increasing serum estradiol levels. On the other hand, medium and high doses of valerian extract could counteract the increase in FSH and LH levels caused by the decrease in estrogen levels after ovariectomy, indicating that valerian extract may have a regulatory effect on the hypothalamic-pituitary-neuroendocrine system. This is of great significance for regulating the endocrine status of postmenopausal women in middle-aged and elderly women and improving menopausal symptoms such as anxiety, insomnia, and irritability related to FSH and LH. In addition, valerian extract has a good regulatory effect on the secretion of hormones and hypothalamic neurotransmitters related to menopause in rats, and has a certain corrective effect on the disorder of central monoamine neurotransmitters in menopausal rats.

[0036] Valerian has a sweet taste and primarily enters the heart and liver meridians. It has calming, qi-regulating, and depression-relieving effects, treating restlessness, palpitations, depression, and epilepsy. Modern pharmacological experiments show that it has sedative, antidepressant, anti-anxiety, anti-epileptic, anticonvulsant, memory-improving, and anti-cerebral ischemia-related central nervous system effects. It also has antiarrhythmic, lipid-lowering, and kidney-protective pharmacological effects. Clinically, menopausal symptoms mainly manifest as insomnia, hot flashes, sweating, dry mouth and throat, irritability, and insomnia with excessive dreaming, which are symptoms of yin deficiency and fire excess. Valerian is significant for treating menopausal symptoms such as palpitations, insomnia, anxiety, and irritability, improving clinical symptoms of menopausal syndrome, and has significant pharmacological activity and efficacy in treating menopausal syndrome.

[0037] Example 4. Clinical therapeutic effects of the present invention To demonstrate the therapeutic effect of the traditional Chinese medicine of this invention on menopausal syndrome, the inventors conducted a clinical observation on 50 cases, including 50 women aged 45-60 years. Inclusion criteria: diagnosed with menopausal syndrome, with clinical symptoms primarily including hot flashes and sweating, irritability, palpitations, insomnia, poor appetite, fatigue, menstrual irregularities, or amenorrhea. The experimental group used the traditional Chinese medicine granules obtained in Example 5, taken three times a day, half an hour after breakfast and dinner. Both groups underwent a 30-day course of treatment, and the efficacy was evaluated after three courses.

[0038] Criteria for judging the efficacy: 1. Cured: clinical symptoms disappear; 2. Significantly effective: symptoms improve significantly; 3. Effective: symptoms improve to some extent; 4. Ineffective: symptoms and signs do not improve.

[0039] The method of administration for this invention is as follows: Take the traditional Chinese medicine capsules described in Example 3 of this invention orally, three times daily after meals; two capsules each time, for one month as one course of treatment. Through taking this invention's medicine, generally 1-6 courses of treatment were required. 47 people were cured, with a cure rate of 94%, and 49 people showed improvement, with an effectiveness rate of 98%.

[0040] Finally, it should be noted that the above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of them. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. The use of a valerian extract in the preparation of a medicament for the prevention and treatment of menopausal syndrome, characterized in that... Menopausal syndrome is caused by estrogen deficiency.

2. The use according to claim 1, characterized in that, The use of this valerian extract in the preparation of health supplements for the prevention of menopausal syndrome caused by estrogen deficiency.

3. The use according to claim 1, characterized in that, The drug is prepared into various oral preparations using valerian herbal materials or valerian extracts as raw materials according to conventional preparation methods. The oral preparations are granules, powders, microcapsules, soft capsules, tablets or oral liquids.

4. The use according to claim 3, characterized in that, The method for preparing the valerian extract involves extracting the effective components of valerian using supercritical carbon dioxide extraction at an extraction temperature below 40°C. Specifically, the method includes the following steps: taking coarse valerian powder, employing supercritical carbon dioxide extraction technology at an extraction temperature of 30–40°C, an extraction pressure of 20–30 MPa, and using an entrainer at a volume of 2–4 times the weight of the herb. The entrainer is measured in ml, and the herb weight is measured in g. The entrainer is selected from methanol, anhydrous ethanol, or 95% ethanol. The desorption temperature is 30–40°C, the desorption pressure is 3–6 MPa, the CO2 flow rate is 10–20 L / h, and the extraction time is 1–2 h.

5. The use according to claim 3, characterized in that, The drug is prepared by mixing and grinding valerian volatile oil inclusions and extract powder.

6. The use according to claim 5, characterized in that, The preparation method of the drug comprises the following steps: 1) Fresh valerian rhizomes and roots are used. After washing away the dirt and draining, they are chopped into 1-5cm long pieces and then distilled using a water-double-barrel pressurized direct steam distillation method. The initial steam pressure is 0.08-0.12mPa / cm². 2 During the distillation process, the steam pressure was 0.02-0.06 mPa / cm. 2 The steam pressure in the later stage of distillation is 0.08-0.10 mPa / cm. 2 The process lasts for 1.5-2.5 hours, during which volatile oil and medicinal residue are separated. 2) The dregs are pre-dried, sun-dried, oven-dried, or vacuum-dried, placed in a percolation tank and compacted. They are then soaked in 70-95% v / v ethanol at a concentration of 1.5 times the amount of fresh medicinal material for 8-12 hours before percolation begins. The percolate is filtered and the ethanol is recovered, then concentrated and dried to obtain valerian dry extract. It is then ground and sieved to obtain valerian extract powder. 3) Take 2-5 times the weight of β-cyclodextrin of volatile oil, add 1-2 times the amount of distilled water and grind evenly, then add valerian volatile oil, grind and mix thoroughly for 20-40 minutes, filter to remove water, wash away unencapsulated volatile oil with petroleum ether at a boiling range of 30-60℃, dry at room temperature, air dry or vacuum dry, grind and sieve to obtain valerian volatile oil β-cyclodextrin inclusion powder; 4) Mix the β-cyclodextrin inclusion complex powder of valerian volatile oil with valerian extract powder and add starch to the fill volume. After mixing evenly, pass through a 38-45 mesh sieve and then fill into capsules to make capsules.

7. The use according to claim 6, characterized in that, This drug is made from the following raw materials in the following weight ratios: 65-68 mg valerian volatile oil, 195-264 mg β-cyclodextrin, 24-30 mg valerian extract powder, 18-24 mg medicinal starch, 28-32 mg 70% ethanol, 0.6-0.7 mg magnesium stearate, and 0.3-0.4 mg talc.

8. The use according to claim 7, characterized in that... This drug is made from the following raw materials in the indicated weight ratios: 66-68 mg valerian volatile oil, 198-206 mg β-cyclodextrin, 26-28 mg valerian extract powder, 20-22 mg medicinal starch, 29-30 mg 70% ethanol, 0.6-0.65 mg magnesium stearate, and 0.3-0.35 mg talc. The valerian volatile oil is a pale yellow clear liquid with a fragrant aroma and a slightly pungent taste. It has a relative density of 0.94-0.96, a refractive index of 1.48-1.49, a heavy metal content of no more than 10 parts per million, and a bornyl acetate content of ≥27%. The valerian extract powder is a brownish-brown powder with a moisture content of <5%, a valerian terpene lactone content of ≥1.3%, and a total terpene lactone content of ≥8.0%. Each capsule contains 0.29g and contains ≥40mg of valerian volatile oil, 25±3mg of valerian extract, >12mg of bornyl acetate, >0.38mg of valerian lactone A, and >5.5mg of total terpene lactones.