Application of Dan'e fukang in preparation of medicine for treating perimenopausal syndrome

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to application of a Dan'e Fukang preparation in preparation of a medicine for treating perimenopausal syndrome. The invention provides application of a Dan'e Fukang preparation in preparation of a medicine for treating perimenopausal syndrome. Pharmacological experiments prove that Dan'e Fukang can reduce the number of activities of mice and prolong the sleep time of the barbital sodium of the mice, and has certain sedative, hypnotic and anxiety-resistant effects; the composition can effectively resist rat foot plantar sweat secretion caused by pilocarpine, and has a certain effect of resisting sweating; moreover, the traditional Chinese medicine composition has an obvious effect of reducing LH, FSH and T in climacteric rats, has an effect of increasing E2 in serum of the climacteric rats, and can be used for effectively treating the perimenopausal syndrome. Dan'e'fukang can reduce the total accumulated immobility time of the rat in the forced swimming experiment; the despair state time of a tail suspension experiment rat is obviously shortened, and a certain anti-depression effect is achieved. The Dan'e Fukang can provide more drug choices for clinical treatment of perimenopausal syndrome diseases.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to the application of Dan'e Fukang in the preparation of drugs for treating perimenopausal syndrome. Background Technology

[0002] Perimenopausal syndrome refers to a series of symptoms caused by the gradual decline or loss of ovarian function and the decrease in estrogen levels during or after menopause, resulting in autonomic nervous system dysfunction and metabolic disorders.

[0003] When women enter menopause, their estrogen levels drop significantly, leading to imbalances in the nervous, mental, psychological, endocrine, and metabolic systems, resulting in perimenopausal syndrome. Symptoms include hot flashes, insomnia, irritability, hot flashes and sweating, mood swings, dizziness and tinnitus, lower back pain, and emotional instability. These symptoms can last from several months to several years, and in severe cases, even 5 to 10 years, significantly impacting the quality of life for perimenopausal women.

[0004] Hormone therapy is a relatively effective treatment for perimenopausal syndrome, but it has many side effects. Long-term use can increase the risk of vascular embolism, sclerosis, breast cancer, and other complications, which increases the psychological and economic burden on patients. In addition, although hormone replacement therapy is fast-acting, symptoms are prone to relapse after discontinuation.

[0005] Traditional Chinese medicine (TCM) treatments are effective with few side effects and have unique advantages that make them easily accepted by patients. Dan'e Fukang, derived from Yi ethnic medicine, has the effects of promoting blood circulation, removing blood stasis, soothing the liver and regulating qi, regulating menstruation and relieving pain, and softening and resolving masses. There are no reports on Dan'e Fukang's use in treating perimenopausal syndrome. Summary of the Invention

[0006] The purpose of this invention is to provide a new pharmaceutical use for Dan'e Fuke preparation.

[0007] This invention provides the application of Dan'e Fukang preparation in the preparation of drugs for treating perimenopausal syndrome.

[0008] Furthermore, the Dan'e Fuke preparation is a preparation made from raw materials including Salvia miltiorrhiza, Curcuma zedoaria, Bupleurum chinense, Panax notoginseng, Paeonia lactiflora, Angelica sinensis, Sparganium stoloniferum, Cyperus rotundus, Corydalis yanhusuo, and Glycyrrhiza uralensis.

[0009] Furthermore, the Dan'e Fuke preparation is an oral preparation.

[0010] Furthermore, the perimenopausal syndrome includes at least one of the following symptoms: (1) perimenopausal sleep disorder; (2) perimenopausal hot flashes and sweating; (3) perimenopausal depression; (4) perimenopausal anxiety.

[0011] Purple Salvia is the dried root of *Salvia przewalskii* Maxim. or *Salvia przewalskii* Maxim. var. *mandarinorum* (Diels) Stib., belonging to the Lamiaceae family. It has the effects of promoting blood circulation, removing blood stasis, regulating menstruation, relieving pain, and calming the mind. It can improve blood circulation and alleviate symptoms such as irregular menstruation and dysmenorrhea.

[0012] Curcuma zedoaria is the dried rhizome of *Curcuma phaeocaulis* VaL., *Curcuma kwangsiensis* S.G.Lee et CFLiang, or *Curcuma wenyujin* YHChenet C.Ling, all belonging to the ginger family. It has the effects of promoting qi circulation, breaking up blood stasis, eliminating stagnation, and relieving pain. It is used for abdominal masses, amenorrhea due to blood stasis, chest pain, and abdominal distension due to food stagnation.

[0013] Yunnan Bupleurum is a processed product of the dried whole herb of Bupleurum marginatum Wall.ex DC., Bupleurum microcephalum Diels., and Bupleurum tenue Buch.-Ham.ex D.Don, all belonging to the Apiaceae family. It can soothe the liver, relieve depression, regulate qi and blood, and alleviate symptoms such as hot flashes, night sweats, and mood swings caused by liver stagnation.

[0014] Panax notoginseng (Burk.) FH Chen, a plant belonging to the Araliaceae family, is known for its dried roots and rhizomes. It is used to disperse blood stasis, stop bleeding, reduce swelling, and relieve pain; it can improve blood circulation and alleviate pain caused by blood stasis.

[0015] Red peony root is the dried root of Paeonia lactiflora Pall. or Paeonia veitchii Lynch, both belonging to the Ranunculaceae family. It clears heat, cools the blood, disperses blood stasis, and relieves pain.

[0016] Angelica sinensis is the dried root of Angelica sinensis (Oliv.) Diels, a plant belonging to the Apiaceae family. It has a sweet and pungent taste, and is warm in nature. It nourishes and invigorates blood circulation, regulates menstruation and relieves pain, and moistens the intestines to promote bowel movements.

[0017] Sanleng is the dried tuber of *Sparganium stoloniferum* Buch.-Ham., a plant in the family Sparganaceae. It is used to promote blood circulation, regulate qi, eliminate stagnation, and relieve pain.

[0018] Cyperus rotundus L., a plant in the Cyperaceae family, is a dried rhizome. It is used to soothe the liver and relieve depression, regulate qi and relieve chest tightness, regulate menstruation and relieve pain, and can alleviate mood swings.

[0019] Corydalis yanhusuo is the dried tuber of the poppy family Corydalis yanhusuo WT. Wang. It is used for chest and rib pain, abdominal pain, angina pectoris, amenorrhea, dysmenorrhea, postpartum blood stasis, and traumatic swelling and pain.

[0020] Licorice is the dried root and rhizome of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L., all belonging to the legume family. Licorice harmonizes the effects of other medications, alleviates their side effects, and enhances overall therapeutic efficacy.

[0021] The inventors discovered through research that Dan'e Fukang can regulate the endocrine system. The chemical components contained in purple salvia, turmeric, notoginseng, cyperus, and angelica have certain estrogen-like effects. They can produce estrogen or anti-estrogenic effects according to the level of estrogen in the body, thereby producing feedback regulation on the hormone secretion of the hypothalamus and pituitary gland, indirectly regulating estrogen levels, and alleviating perimenopausal symptoms caused by fluctuations or decreases in estrogen.

[0022] Through the inventors' research, it was also discovered that Dan'e Fukang has a certain regulatory effect on the nervous system; Zidanshen can promote blood supply to the brain, relieve insomnia and dizziness caused by insufficient qi and blood, thereby improving sleep quality; Ezhu has the effects of breaking up blood stasis, promoting qi circulation, eliminating stagnation and relieving pain, and its application in nervous system diseases mainly focuses on improving blood circulation and treating qi stagnation and blood stasis; Dianchaihu has the effect of soothing the liver and relieving depression, which can relieve emotional fluctuations and chest tightness. In addition, Dianchaihu also has the effects of harmonizing qi and blood, enhancing immunity, and relieving fatigue, which has a certain positive impact on the nervous system; the chemical components in Sanqi have a certain inhibitory effect on the central nervous system, and have the effects of sedation, tranquilization and sleep improvement; the active ingredients in Chishao can exert a neuroprotective effect through mechanisms such as inhibiting neuroinflammation, regulating the gut-brain axis and improving brain damage and dysfunction; Danggui has a certain sedative and calming effect, which can relieve anxiety, insomnia and other nervous system problems; Xiangfu can regulate the central nervous system, improve mood and sleep quality, and help relieve symptoms such as chest tightness and irritability caused by emotional depression. The chemical components in Corydalis can also regulate the nervous system, relieve anxiety and tension, and have a certain improving effect on neurasthenia and depression. Dan'e Fukang can also enhance the body's immunity and alleviate perimenopausal syndrome symptoms by regulating the function of the immune system.

[0023] The beneficial effects of this invention are:

[0024] This invention provides the application of Dan'e Fukang in the preparation of drugs for treating perimenopausal syndrome. Dan'e Fukang preparations can regulate hormone levels and improve the endocrine disorder during perimenopause; regulate the central nervous system, improve the patient's emotional state, and alleviate symptoms such as anxiety, depression, and insomnia; and improve microcirculation, making the blood supply to various parts of the body more uniform, which helps to maintain stable body temperature and reduce sweating.

[0025] Pharmacological experiments have demonstrated that Dan'e Fukang can reduce the activity level of mice and prolong the sodium barbital sleep time, exhibiting certain sedative-hypnotic and anti-anxiety effects. It can effectively counteract pilocarpine-induced sweating in rats, demonstrating a certain anti-sweating effect. Furthermore, it significantly reduces LH, FSH, and T levels in menopausal rats and increases serum E2 levels, thus effectively treating perimenopausal syndrome. Dan'e Fukang can reduce the cumulative immobility time in forced swimming rats and significantly reduce the despair state time in tail suspension rats, exhibiting a certain antidepressant effect. Compared to Western estrogen drugs, Dan'e Fukang has better safety profiles and can provide more medication options for the clinical treatment of perimenopausal syndrome. Detailed Implementation

[0026] The present invention will be further described in detail below through specific embodiments. All drugs and reagents involved in the specific embodiments are commercially available.

[0027] Example 1

[0028] The Dan'e Fuke Decoction was prepared according to the national drug standard WS-10227 (ZD-0227) 2002-2012Z-2016, as follows: 450g of Salvia miltiorrhiza, 250g of Curcuma zedoaria, 250g of Bupleurum chinense, 150g of Panax notoginseng, 250g of Paeonia lactiflora, 250g of Angelica sinensis, 175g of Sparganium stoloniferum, 150g of Cyperus rotundus, 175g of Corydalis yanhusuo, and 100g of Glycyrrhiza uralensis.

[0029] The above ten herbs—Salvia miltiorrhiza, Curcuma zedoaria, Panax notoginseng, Angelica sinensis, and Corydalis yanhusuo—were soaked in 70% ethanol for 24 hours. The mixture was then percolated at a rate of 2–4 mL per minute, collecting approximately 5800 mL of the percolate. The ethanol was recovered under reduced pressure and concentrated to a thick paste with a relative density of 1.30–1.35 (50°C). The dregs were then decocted twice with the remaining five herbs, including Bupleurum chinense, for 2 hours each time. The decoctions were combined, filtered, and the filtrate was concentrated to a thick paste with a relative density of 1.30–1.35 (50°C). The two thick pastes were combined, and an appropriate amount of refined honey-refined sugar (100:165) and 3 g of potassium sorbate were added. The mixture was then stirred until 1000 g was obtained.

[0030] Example 2: Sedative-hypnotic effects of Dan'e Fuke

[0031] 2.1 Experimental Materials

[0032] 2.1.1 Laboratory Animals

[0033] Female Kunming mice, weighing 22–26g, were provided by Sichuan Vitonlihua Laboratory Animal Technology Co., Ltd.

[0034] 2.1.2 Experimental reagents

[0035] Test drugs: Dan'e Fuke Decoction (Yunnan Shengke Pharmaceutical Co., Ltd., National Drug Approval Number: Z20025253, Specification: 150g / bottle, Product Batch Number: 221005); Sodium Pentobarbital (purchased from Sigma-Aldrich); Kuntai Capsules (Guiyang Xintian Pharmaceutical Co., Ltd., Approval Number: National Drug Approval Number Z20000083)

[0036] 2.2 Experimental Methods

[0037] Castrated Kunming female mice with bilateral ovariectomy were randomly divided into four groups: a high-dose group, a medium-dose group, a low-dose group, a positive control group, and a model group, with 10 mice in each group. Ten mice were reserved as a sham-operated group; their skin was incised to expose the ovaries, but the ovaries were not removed. Mice were fasted for 12 hours before the experiment. The model and sham-operated groups were administered vegetable oil by gavage. The high-dose, medium-dose, and low-dose groups of Dan'e Fukang were administered Dan'e Fukang decoction by gavage, with the high dose being 12.4 g / kg, the medium dose 6.2 g / kg, and the low dose 3.1 g / kg respectively, all in vegetable oil solutions. The positive control group was administered Kuntai capsules at a dose of 2.5 g / kg. Thirty minutes after administration, the mice were placed in an activity box for 12 minutes to acclimatize, and their spontaneous activity was recorded within 10 minutes. The experiment was conducted in a quiet environment with a constant room temperature. The mice were administered the drug via gavage for 7 days, once daily. Fifty minutes after the last administration, a threshold dose of sodium pentobarbital (50 mg / kg) was injected intraperitoneally. The duration of sleep was measured as the time from the disappearance to the recovery of the righting reflex in each mouse. The results are shown in Table 1.

[0038] Table 1. Results of spontaneous activity and sleep time in mice of each group (mean±SD, n=10)

[0039] Compared with the sham surgery group Δ p < 0.05, ΔΔ p < 0.01; compared with the model group * p < 0.05, ** p < 0.01; compared with the positive control group # p < 0.05, ## p < 0.01.

[0040] The results are shown in Table 1: Compared with the sham-operated group, the spontaneous activity of mice in the model group was significantly increased (p < 0.01) and the sleep time was significantly reduced (p < 0.05); the high, medium and low dose groups of Dan'e Fukang could significantly reduce the activity of mice and prolong the sodium barbital sleep time of mice, and had certain sedative, hypnotic and anti-anxiety effects.

[0041] Example 3: Effects of Dan'e Fuke on sweat secretion in the plantar region of rats

[0042] 3.1 Experimental Materials

[0043] 3.1.1 Laboratory Animals

[0044] Female Wistar rats, aged 11–15 months and weighing 280–350g, were provided by Spiford (Beijing) Biotechnology Co., Ltd.

[0045] 3.1.2 Experimental reagents

[0046] Test drugs: Dan'e Fuke Decoction (Yunnan Shengke Pharmaceutical Co., Ltd., National Drug Approval Number: Z20025253, Specification: 150g / bottle); Hairy Rutaecarpa Extract (purchased from Chengdu Pusi Biotechnology Co., Ltd.)

[0047] 3.2 Experimental Methods

[0048] Fifty female rats aged 11–15 months were selected. Rats exhibiting irregular estrous cycles, as determined by vaginal cytology smear examination, were classified as menopausal rats. Pilocarpine 0.035 g / kg was administered, and the rats were randomly divided into four groups: control group, positive control group, high-dose Dan'e Fuke group, medium-dose group, and low-dose group. The high-dose, medium-dose, and low-dose groups of Dan'e Fuke were administered Dan'e Fuke decoction at doses of 1.55 g / kg, 3.1 g / kg, and 6.2 g / kg, respectively, once daily for four weeks, concurrently with pilocarpine. The control group received an equal volume of distilled water. The positive control group received atropine 0.05 mg / kg, once daily for four weeks, concurrently with pilocarpine. The number of sweat spots was measured 30 minutes after administration.

[0049] Table 2. Effects of each group on sweat secretion in the plantar region of rats ( (±s, n=10)

[0050]

[0051] Compared with the control group, * p < 0.05, ** p < 0.01.

[0052] The results are shown in Table 2: The high, medium, and low dose groups of Dan'e Fukang all effectively counteracted the secretion of sweat on the plantar part of the rats induced by pilocarpine, indicating that Dan'e Fukang has a certain effect in resisting sweating.

[0053] Example 4 Regulatory Effect of Dan'e Fukang on Hormone Levels in Ovarian Rats

[0054] 4.1 Experimental Materials

[0055] 4.1.1 Experimental Animals

[0056] Female Wistar rats, 11 - 15 months old, weighing 280g - 350g; female Wistar rats, 5 - 6 months old, weighing 200g - 250g; provided by Spf (Beijing) Biotechnology Co., Ltd.

[0057] 4.1.2 Experimental Drugs

[0058] Test drug: Dan'e Fukang decoction extract (Yunnan Shengke Pharmaceutical Co., Ltd., national drug approval number: Z20025253, specification: 150g / bottle); diethylstilbestrol (purchased from Wuhan Kemike Biopharmaceutical Technology Co., Ltd.)

[0059] 4.2 Experimental Methods

[0060] Fifty female rats aged 11 - 15 months were selected. After vaginal exfoliated cell smear examination, those with irregular estrous cycles were defined as menopausal rats. They were randomly divided into a menopausal control group, a positive control group, high, medium, and low dose groups of Dan'e Fukang, with 10 rats in each group. The high, medium, and low dose groups of Dan'e Fukang were respectively administered Dan'e Fukang decoction extract at 6.2g / kg, 3.1g / kg, and 1.55g / kg once a day for 4 consecutive weeks. The menopausal control group was given the same volume of distilled water, and the positive control group was administered diethylstilbestrol at 6mg / kg once a day for 4 consecutive weeks. At the same time, another 10 rats aged 5 - 6 months with a body weight of 200g - 250g were set as the young control group and given the same volume of distilled water. One hour after the last administration, blood was taken from the eyes to prepare serum, and radioimmunoassay was used to measure LH, FSH, E2, and T in different states, and t - test was used for statistics.

[0061] Table 3 Test Results of LH, FSH, E2, and T in Rats of Each Group ( ±s, n = 10)

[0062]

[0063] Compared with the menopausal control group, * p < 0.05, ** p < 0.01.

[0064] The results are shown in Table 3: High, medium, and low doses of Dan'e Fukang significantly reduced LH, FSH, and T levels in menopausal rats, and increased serum E2 levels in menopausal rats. This indicates that Dan'e Fukang has an effect on…

[0065] The hormone levels of menopausal female mice have an effective bidirectional regulatory effect.

[0066] Example 5: Antidepressant effect of Dan'e Fuke

[0067] 5.1 Experimental Materials

[0068] 5.1.1 Laboratory Animals

[0069] Female SD rats, SPF grade, weighing 250g–270g; provided by Beijing Huafukang Biotechnology Co., Ltd.

[0070] 5.1.2 Experimental reagents

[0071] Test drugs: Dan'e Fuke Decoction (Yunnan Shengke Pharmaceutical Co., Ltd., National Drug Approval Number: Z20025253, Specification: 150g / bottle); Sodium pentobarbital (purchased from Sigma-Aldrich); Liver-Soothing and Depression-Relieving Capsules (purchased from Sichuan Jishengtang Pharmaceutical Co., Ltd., National Drug Approval Number Z20174037, 0.36g×28 capsules)

[0072] 5.2 Preparation of a perimenopausal rat model

[0073] A perimenopausal rat model was established using bilateral ovariectomy: Rats were anesthetized by an abdominal injection of 0.3% sodium pentobarbital (0.15 mL / 100 g). The skin from the lowest costal margin to the sacrococcygeal region on the rat's back was prepared and thoroughly disinfected with povidone-iodine. A longitudinal incision was made approximately 1.5 cm lateral to the spine and 1 cm from the lowest costal margin, with a long axis of approximately 2 cm. The skin and fascia were incised layer by layer, and the muscles were bluntly dissected to expose the abdominal adipose tissue. The ovary was located within the adipose tissue, and after thorough hemostasis along the distal cervix, it was removed. After confirming no active bleeding, the remaining tissue was returned to its original position. The wound was sutured layer by layer and thoroughly disinfected with povidone-iodine. A clean dressing was applied to the wound. Penicillin was administered intramuscularly at a dose of 200,000 U / rat to prevent infection. Postoperatively, the rats were housed individually in clean bedding, fasted and deprived of water for 24 hours, and their condition was closely monitored. Nine days after the operation, the rats were allowed to recover. Starting from the 10th day, for five consecutive days, 0.5 mL of physiological saline was used to aspirate and smear the exfoliated cells from the rat vagina using a disposable sampling tube. After HE staining, the estrous cycle of the rats was observed and recorded. If no regular estrous cycle appeared, it was considered that the model was successfully established.

[0074] 5.3 Animal grouping and administration methods

[0075] Fifty successfully modeled rats were randomly divided into five groups of ten each: a model group, a high-dose Dan'e Fuke group (6.2 g / kg), a medium-dose Dan'e Fuke group (3.1 g / kg), a low-dose Dan'e Fuke group (1.55 g / kg), and a positive control group (0.13 g / kg of Shugan Jieyu capsules). Animals in the treatment groups were administered the drug via gavage once daily for 28 days at a volume of 10 mL / kg. The model group received the same volume of physiological saline. Ten pre-treated animals were designated as a sham-operated group. Except for the sham-operated group, all other groups underwent a 28-day CUMS model. During the stress modeling period, animals were administered drugs concurrently with the treatment. Drug administration was performed at 8:00 AM daily, followed by daytime stress treatment 1.5 hours later, and nighttime stress treatment at 7:00 PM.

[0076] 5.4 Evaluation of Depressive Behaviors

[0077] 5.4.1 Forced Swimming Experiment

[0078] Prepare a cylindrical transparent container 50cm high and 20cm in diameter, fill it with water to a depth of 15cm, and control the water temperature to room temperature (23-25℃). Perform acclimatization training on rats at least 24 hours in advance, placing each rat in the water for 15 minutes. After removing and drying the rats, return them to their original rearing environment. The next day, conduct the formal experiment, placing the rats in the water for 6 minutes and recording the time it takes for the rat to enter a state of despair (relative stillness) within 4 minutes. The water should be changed between rats to avoid the former's effect. The criteria for judging the rat's state of despair during the forced swimming experiment are: 1. Cessation of exploratory activity; 2. Cessation or reduction of limb movement; 3. Slightly closed eyes. If condition 1 is met, and condition 2 or 3 is also met, the rat is considered to have entered a state of despair.

[0079] 5.4.2 Tail Suspension Test

[0080] Prepare a support frame 50cm off the ground. Secure the rat's tail base to the frame with a thin rope, ensuring the rat's head is 15cm above the ground. Time the test for 6 minutes, then calculate the time it takes for the rat to enter a state of despair (relative stillness) within the last 4 minutes. The criteria for determining despair in the tail suspension test are: 1. Cessation of exploratory activity; 2. Cessation of limb movement; 3. Slightly closed eyes. If condition 1 is met, and condition 2 or 3 is also met, the rat is considered to have entered a state of despair.

[0081] 5.5 Results

[0082] Table 4. Effects of Danshenfukang on depressive behavioral tasks in perimenopausal rats ( ±s,n=10)

[0083]

[0084] Note: Compared with the sham surgery group. ▲ P < 0.05▲▲ P < 0.01; compared with the model group, * P < 0.05 ** P < 0.01; compared with the positive control group, # P < 0.05 ## P < 0.01.

[0085] The results are shown in Table 4. Compared with the sham-operated group, the cumulative total immobility time of rats in the forced swimming experiment was significantly increased in the model group (P < 0.01). Compared with the model group, the cumulative total immobility time of rats in the high, medium, and low dose groups of Dan'e Fuke was decreased; compared with the positive control group, the cumulative total immobility time of rats in the high and medium dose groups of Dan'e Fuke was significantly decreased (P < 0.05).

[0086] Compared with the sham-operated group, the duration of the despair state in the tail suspension experiment was significantly increased in the model group (P < 0.01). Compared with the model group, the duration of the despair state in the tail suspension experiment was significantly decreased in the medium-dose Dan'e Fuke group (P < 0.05).

[0087] In summary, Dan'e Fukang can reduce the activity frequency of mice and prolong the sodium barbital sleep time, exhibiting certain sedative, hypnotic, and anti-anxiety effects. It can effectively counteract pilocarpine-induced sweat secretion in rats, demonstrating a certain anti-sweating effect. Furthermore, it significantly reduces LH, FSH, and T levels in menopausal rats and increases serum E2 levels, effectively treating perimenopausal syndrome. Dan'e Fukang can also reduce the cumulative immobility time in rats subjected to forced swimming and significantly reduce the despair state time in rats subjected to tail suspension experiments, indicating a certain antidepressant effect.

Claims

1. Application of Dan'e Fuke preparation in the preparation of drugs for treating perimenopausal syndrome.

2. The application according to claim 1, characterized in that: The Dan'e Fuke preparation is made from raw materials including Salvia miltiorrhiza, Curcuma zedoaria, Bupleurum chinense, Panax notoginseng, Paeonia lactiflora, Angelica sinensis, Sparganium stoloniferum, Cyperus rotundus, Corydalis yanhusuo, and Glycyrrhiza uralensis.

3. The application according to claim 1, characterized in that: The Dan'e Fuke preparation is an oral preparation.

4. The application according to claim 1, characterized in that: The perimenopausal syndrome includes at least one of the following symptoms: (1) Perimenopausal sleep disorders; (2) Perimenopause hot flashes and sweating; (3) Perimenopausal depression; (4) Perimenopausal anxiety.

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