Traditional Chinese medicine composition for treating perimenopausal depression as well as preparation method and application of traditional Chinese medicine composition

The traditional Chinese medicine composition Lily Dihuang Decoction combined with Danggui Shaoyao San is added to the ingredients such as Yejiao, Gardenia, Floating Wheat, Vinegar, Green Plum Blossom, Green Plum Blossom, Green Skin, etc., and is prepared into tablets, capsules or oral liquids, which solves the problem of poor efficacy in the treatment of perimenopause depression in the prior art, and achieves significant symptom improvement and physiological regulation effects.

CN120227436AActive Publication Date: 2025-07-01HUNAN UNIV OF CHINESE MEDICINE
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Patent Information

Application Number
CN202510582002.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-05-07
Publication Date
2025-07-01
Estimated Expiration
2045-05-07

AI Technical Summary

Technical Problem

The prior art has limited effectiveness in treating perimenopause depression, and cannot effectively improve symptoms such as depression, depression and negative psychological emotions, and lacks significant drug efficacy.

Method used

Provided is a traditional Chinese medicine composition, including lily, Rehmannia, Angelica sinensis, white peony, Poria cocos, Chuanxiong, Alisma, Atractylodes, Nightclub, Gardenia, Floating Wheat, Vinegar, Green Plum Blossom, Green Plum Blossom, Green Skin, Roasted Licorice and Date, etc., which are prepared into tablets, capsules, granules or oral liquids through specific decoction and concentration methods, for the treatment of perimenopause depression.

Benefits of technology

Significantly improve the symptoms of perimenopause depression, increase the time when mice enter the central area, reduce the rate of erotic cycle disorders, improve sugar water preference, regulate gonadotropin release and estrogen levels, and enhance the therapeutic effect.

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Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating perimenopausal depression and a preparation method and application thereof.The traditional Chinese medicine composition is prepared from, by weight, 12-17 parts of lily, 12-17 parts of rehmannia, 8-10 parts of angelica sinensis, 12-17 parts of radix paeoniae alba, 10-15 parts of poria cocos, 8-10 parts of ligusticum wallichii, 10-15 parts of rhizoma alismatis, 10-15 parts of rhizoma atractylodis macrocephalae, 12-17 parts of tuber fleeceflower stem, 8-10 parts of cape jasmine and 12-17 parts of light wheat. , 4-8 parts of vinegar-processed rhizoma cyperi, 4-8 parts of green plum blossom, 4-8 parts of pericarpium citri reticulatae viride, 2-4 parts of honey-fried licorice root, 12-17 parts of jujube and 10-15 parts of radix curcumae. The traditional Chinese medicine composition can improve the effect of treating the perimenopausal depression.
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Description

Technical Field

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

[0002] Perimenopause refers to a period before and after menopause in women. With the decline of ovarian function and the degradation of hypothalamic-pituitary function in perimenopausal women, it can lead to fluctuations and decreases in sex hormone levels, promote changes in the body's endocrine environment, and then cause a series of clinical manifestations such as menstrual disorders, dizziness, and hot flashes, that is, perimenopausal syndrome. If the symptoms cannot be further improved, it can cause negative psychological emotions such as low mood, depression, and pessimism, and in severe cases, the condition can even progress to perimenopausal depression (PMD).

[0003] PMD belongs to the categories of "zangzao", "yuzheng", "various syndromes before and after menopause" and other in traditional Chinese medicine. In perimenopausal women, tiankui is about to exhaust, kidney qi gradually declines, chong and ren meridians are deficient, qi and blood, yin and yang are out of balance, and visceral functions are disordered, resulting in emotional disorders and prone to depression. This disease is based on the kidney and is closely related to the liver, and can involve the heart, spleen, stomach and other viscera; currently, it is generally believed that its pathogenesis is kidney deficiency and liver depression, and the treatment principles and methods are mainly to tonify the kidney and fill essence, regulate qi and soothe the liver. Research progress on the pathogenesis and prevention and treatment of perimenopausal depression with traditional Chinese medicine, Zhu Lijun et al., Chinese Journal of Experimental Traditional Medical Formulae, published on April 10, 2024, disclosed the mechanism of action of traditional Chinese medicine active ingredients in treating PMD, and its active ingredients mainly come from Pueraria lobata, Epimedium brevicornu, Cynomorium songaricum, Curcuma longa, Curculigo orchioides, Salvia officinalis, Polygonum cuspidatum, Astragalus membranaceus, Bupleurum chinense, Panax ginseng, etc. The main prescriptions are Jiawei Baihe Dihuang Decoction, Minor Bupleurum Decoction, Taohong Siwu Decoction, and Zishen Shugan Decoction. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for treating perimenopausal depression, a preparation method and uses thereof, so as to improve the treatment effect of perimenopausal depression.

[0005] An embodiment of the present invention provides a traditional Chinese medicine composition for treating perimenopausal depression, which comprises the following raw material components in parts by weight: 12 - 17 parts of Lilium brownii, 12 - 17 parts of Rehmannia glutinosa, 8 - 10 parts of Angelica sinensis, 12 - 17 parts of Paeonia lactiflora, 10 - 15 parts of Poria cocos, 8 - 10 parts of Ligusticum chuanxiong, 10 - 15 parts of Alisma orientale, 10 - 15 parts of Atractylodes macrocephala, 12 - 17 parts of Polygonum multiflorum Thunb. var. thomsonii, 8 - 10 parts of Gardenia jasminoides, 12 - 17 parts of Fructus Tritici Levis, 4 - 8 parts of Cyperus rotundus L. var. aromaticus, 4 - 8 parts of Flos Chloranthi, 4 - 8 parts of Pericarpium Citri Reticulatae Viride, 2 - 4 parts of Radix Glycyrrhizae Preparata, 12 - 17 parts of Fructus Jujubae, 10 - 15 parts of Curcuma aromatica Salisb.

[0006] Preferably, it comprises the following raw material components in parts by weight: 14-16 parts of lily, 14-16 parts of rehmannia root, 8-10 parts of angelica sinensis, 14-16 parts of white peony root, 11-13 parts of poria cocos, 8-10 parts of chuanxiong rhizome, 11-13 parts of alisma orientale, 11-13 parts of atractylodes macrocephala, 14-16 parts of polygonum multiflorum thunb, 8-10 parts of gardenia jasminoides, 14-16 parts of fructus tritici levis, 5-7 parts of cyperus rotundus, 5-7 parts of green plum, 5-7 parts of green tangerine peel, 2-4 parts of honey-fried licorice root, 14-16 parts of jujube, 11-13 parts of turmeric root-tuber.

[0007] Preferably, it comprises the following raw material components in parts by weight: 15 parts of lily, 15 parts of rehmannia root, 9 parts of angelica sinensis, 15 parts of white peony root, 12 parts of poria cocos, 9 parts of chuanxiong rhizome, 12 parts of alisma orientale, 12 parts of atractylodes macrocephala, 15 parts of polygonum multiflorum thunb, 9 parts of gardenia jasminoides, 15 parts of fructus tritici levis, 6 parts of cyperus rotundus, 6 parts of green plum, 6 parts of green tangerine peel, 3 parts of honey-fried licorice root, 15 parts of jujube, 12 parts of turmeric root-tuber.

[0008] Preferably, the dosage form of the traditional Chinese medicine composition is tablet, capsule, granule, pill or oral liquid.

[0009] The embodiment of the present invention provides a preparation method of the traditional Chinese medicine composition. Mix the traditional Chinese medicine components, decoct twice with water. Add 8-12 times the amount of water for the first time and 5-7 times the amount of water for the second time. Combine the decoction liquids, filter, and concentrate to obtain the traditional Chinese medicine composition.

[0010] Preferably, add 10 times the amount of water for the first time and 6 times the amount of water for the second time.

[0011] Preferably, the decocting time for the first time is 1-2 h and the decocting time for the second time is 0.5-1 h.

[0012] Preferably, the relative density of the concentrated medicinal liquid is 1.3-1.4.

[0013] The embodiment of the present invention provides a use of the traditional Chinese medicine composition. The traditional Chinese medicine composition is used for preparing a drug for treating perimenopausal depression.

[0014] The beneficial effects of the present invention are as follows: In the present invention, lily nourishes yin and moistens the lung, clears the heart and calms the mind; rehmannia root nourishes yin and cools the blood, nourishes yin and promotes the production of body fluid. The two are combined in compatibility, which can nourish yin and clear heat, nourish the heart and moisten the lung, and improve symptoms such as restlessness, mental trance, insomnia and dreaminess. White peony root nourishes blood and softens the liver, angelica sinensis nourishes blood and promotes blood circulation, helps peony root to nourish the liver blood, chuanxiong rhizome promotes qi stagnation in blood, qi movement promotes blood movement and does not cause stasis, alisma orientale promotes diuresis and reduces dampness, atractylodes macrocephala and poria cocos strengthen the spleen and remove dampness, and the three drugs are combined to treat the spleen. Sufficient liver blood leads to smooth qi movement, and a healthy spleen function leads to the elimination of damp pathogens.

[0015] The whole prescription is used to soothe the liver, relieve depression, promote qi movement, nourish blood and activate blood circulation, strengthen the spleen and promote diuresis. Polygonum multiflorum Thunb. nourishes the heart and soothes the mind, dredges collaterals and dispels wind; Gardenia jasminoides Ellis purges fire and relieves restlessness, clears heat and promotes diuresis; Fructus Tritici Levis benefits qi and consolidates the exterior, nourishes the heart and soothes the mind; Rhizoma Cyperi (processed with vinegar) soothes the liver and relieves depression, regulates menstruation and alleviates pain; Flos Chloranthi and Pericarpium Citri Reticulatae Viride soothe the liver and regulate qi; Radix Curcumae promotes blood circulation to relieve pain, promotes qi movement to relieve depression, clears the heart and cools the blood; Fructus Jujubae and Radix Glycyrrhizae Preparata harmonize the properties of various drugs and invigorate the middle-jiao and replenish qi. The combination of these herbs enhances the effects of nourishing the heart and soothing the mind, soothe the liver and relieve depression, activating blood circulation to dissipate stasis.

[0016] On the basis of Baihe Dihuang Decoction and Danggui Shaoyao Powder, the present invention adds Polygonum multiflorum Thunb., Gardenia jasminoides Ellis, Fructus Tritici Levis, Rhizoma Cyperi (processed with vinegar), Flos Chloranthi, Pericarpium Citri Reticulatae Viride, etc. Through experiments, it is found that the traditional Chinese medicine composition of the present invention can significantly increase body weight, reduce the disorder rate, increase the time of mice entering the central area, and significantly increase the OE% and OT% values in the treatment of perimenopausal depression compared with the compositions of Comparative Examples 1-3. It can significantly improve the sucrose preference of model mice and significantly enhance the regulatory effects on LH and E2, that is, it has a good effect in treating perimenopausal depression. Description of the Drawings

[0017] Figure 1 Examples of smears of vaginal exfoliated cells of mice at each stage (20×); among them, (A) is proestrus, (B) is estrus, (C) is metestrus, and (D) is diestrus.

[0018] Figure 2 Track diagrams of open field tests for each group of mice.

[0019] Figure 3 Track diagrams of elevated plus maze tests for each group of mice. Detailed Description of the Invention

[0020] Example 1 A traditional Chinese medicine composition for treating perimenopausal depression, comprising the following traditional Chinese medicine components in parts by weight: 15 g of Bulbus Lilii, 15 g of Radix Rehmanniae, 9 g of Radix Angelicae Sinensis, 15 g of Radix Paeoniae Alba, 12 g of Poria, 9 g of Rhizoma Chuanxiong, 12 g of Rhizoma Alismatis, 12 g of Rhizoma Atractylodis Macrocephalae, 15 g of Caulis Polygoni Multiflori, 9 g of Fructus Gardeniae, 15 g of Fructus Tritici Levis, 6 g of Rhizoma Cyperi (processed with vinegar), 6 g of Flos Chloranthi, 6 g of Pericarpium Citri Reticulatae Viride, 3 g of Radix Glycyrrhizae Preparata, 15 g of Fructus Jujubae, and 12 g of Radix Curcumae.

[0021] The preparation method of the traditional Chinese medicine composition for treating perimenopausal depression is to mix the above traditional Chinese medicine components, decoct twice with water. The first time, add 10 times the amount of water and decoct for 2 hours, and the second time, add 6 times the amount of water and decoct for 1 hour. Combine the decoctions, filter, and concentrate to a relative density of 1.3-1.4 to obtain the traditional Chinese medicine composition.

[0022] Comparative Example 1 Compared with Example 1, the difference lies in that it includes the following parts by weight of traditional Chinese medicine components: 28 g of lily, 28 g of raw rehmannia root, 17 g of angelica, 28 g of white peony root, 23 g of poria, 17 g of chuanxiong rhizome, 22 g of alisma, and 23 g of atractylodes macrocephala. Others are the same as in Example 1.

[0023] Comparative Example 2 Compared with Example 1, the difference lies in that it includes the following parts by weight of traditional Chinese medicine components: 15 g of lily, 15 g of raw rehmannia root, 9 g of angelica, 15 g of white peony root, 12 g of poria, 9 g of chuanxiong rhizome, 12 g of alisma, 12 g of atractylodes macrocephala, 15 g of polygala root, 9 g of gardenia fruit, 15 g of albizia flower, 6 g of poria with hostwood, 6 g of roasted epimedium, 6 g of immature bitter orange, 3 g of roasted licorice root, 15 g of Chinese date, and 12 g of turmeric root-tuber. Others are the same as in Example 1.

[0024] Comparative Example 3 Compared with Example 1, the difference lies in that it includes the following parts by weight of traditional Chinese medicine components: 28 g of lily, 28 g of rehmannia root, 17 g of angelica, 28 g of white peony root, 23 g of poria, 17 g of chuanxiong rhizome, 23 g of alisma, and 22 g of atractylodes macrocephala. Others are the same as in Example 1. Comparative Example 3 is composed of Lily-Rehmannia Decoction and Danggui Shaoyao Powder, and it is the classical prescription group.

[0025] Example 2 1. Experimental animals C57BL / 6 mice, female, 8 weeks old, weighing 18 - 22 g, 56 in number, purchased from Hunan Slack Jingda Experimental Animal Co., Ltd.

[0026] 2. Drugs Compound of traditional Chinese medicine under test: The prescription is shown in Example 1. Groups of Comparative Examples 1 - 3 are shown in Comparative Examples 1 - 3.

[0027] Positive drug: Flupentixol and Melitracen Tablets, purchased from Lundbeck A / S, Denmark, approval number H20171104, specification: 0.5 mg of flupentixol and 10 mg of melitracen per tablet × 20 tablets.

[0028] 3. Grouping and model establishment After the animals were purchased, they were adaptively fed for 5 days. The baseline depressive behaviors of each animal were detected by the sucrose preference test. According to the sucrose preference, the animals were randomly divided into 7 groups, including a blank control group, a model group, a positive drug group, a comparative example group 1, a comparative example group 2, a comparative example group 3 (i.e., the classical prescription group), and an example 1 group (i.e., the test drug group), with 8 animals in each group. Except for the blank control group, the rest of the mice were established with a perimenopausal depression (PDD) animal model by using the method of ovariectomy (OVX) combined with chronic unpredictable stress (CUS). The mice were anesthetized by intraperitoneal injection of 2% sodium pentobarbital (60 mg / kg). A bilateral longitudinal incision was made about 1 cm on both sides of the spine at the lower 1 / 3 of the trunk, the fat mass was separated, both ovaries were ligated and excised to complete the castration, and the incision was sutured after the operation. The mice in the blank control group had their abdominal cavities opened under anesthesia, adipose tissue equivalent to the volume of the ovaries was excised, and then the incision was sutured. Penicillin was injected into the thigh muscles after the operation to prevent infection. After the operation, vaginal smears were detected in the mice for 5 consecutive days. If no estrous cycle was seen for 5 consecutive days, the castration treatment was considered successful.

[0029] CUS modeling was continued for 6 weeks. The modeling methods included: Cold water bath swimming at 4°C for 5 minutes: Simulating cold stress, with a duration of 5 minutes.

[0030] Tail clamping for 1 minute: Inducing an acute stress response by clamping the mouse's tail for 1 minute.

[0031] Exposure to wet bedding for 24 hours: Placing the mice in a humid environment for 24 hours to increase environmental stress.

[0032] Reversal of day and night for 24 hours: Changing the circadian rhythm of the mice to simulate circadian clock disruption.

[0033] Restraint for 6 hours: Fixing the mice in a narrow space for 6 hours to induce a stress response.

[0034] Food and water deprivation for 24 hours: Depriving the mice of food and water for 24 hours to create physiological stress.

[0035] Foot shock (2 mA, 1 s / time, 10 times / min) for 2 minutes: Using electric shock to stimulate the plantar nerves of the mice to produce pain and stress.

[0036] 90 dB noise for 4 hours: Continuous noise interference for 4 hours to simulate the stress effect of noise pollution.

[0037] One stress method was randomly adopted every day, and the same stress method was not used continuously to ensure the diversity and randomness of stress and avoid adaptation caused by a single stress method.

[0038] 4. Animal administration Gavage administration was started on the first day of CUS model establishment. Among them, the positive drug was given as flupentixol melitracen tablets, and the administration dose was 2.73 mg / kg / d (the daily adult dose is 21 mg, the clinical equivalent dose); the groups of Example 1 and Comparative Examples 1-3 were given the corresponding drugs at 8.06 g / kg / d (1 / 3 times the clinical equivalent dose), and the blank control group and the model group were given an equal volume of distilled water, and the administration volume was 20 mL / kg.

[0039] 5. Index detection (1) Body weight Each group of mice was weighed regularly once a week, and the body weight changes were recorded.

[0040] (2) Open field test The open field test was used to evaluate the activity, exploratory behavior and anxiety-depression level of mice in a new environment. The mice were placed in a black open experimental box, and their spontaneous activity behavior was observed. The total activity distance, the residence time in the central area and the activity distance in the central area of the animals were recorded. Mice with a higher anxiety level stayed in the central area for a shorter time and had a smaller activity distance, showing more marginal activities, while animals with a higher depression level also had a significantly reduced total activity distance.

[0041] (3) Elevated plus maze test The elevated plus maze test was used to evaluate the anxiety behavior of mice. During the experiment, the number of times the mice entered the open arms and the closed arms within 5 minutes and the residence time in the open arms were recorded. Calculate the open-arm entry percentage (OE) = the number of times entering the open arms / (the number of times entering the open arms + the number of times entering the closed arms) × 100%; the open-arm residence time percentage (OT) = the residence time in the open arms / (the residence time in the open arms + the residence time in the closed arms) × 100%. Mice with a higher anxiety level usually entered the open arms less frequently and had a shorter residence time, showing stronger avoidance behavior.

[0042] (4) Sucrose preference test The sucrose preference test was used to evaluate the degree of anhedonia in mice, which is one of the most classic behavioral indexes for animal models of depression and drug efficacy evaluation. During the experiment, two bottles of 2% sucrose solution and distilled water were placed at the drinking place of the mice, and the mice were allowed to freely choose to drink. The drinking amounts of the sucrose solution and distilled water within a certain period of time were recorded, and the sucrose preference value was calculated. The formula is: sucrose preference value = sucrose intake / (sucrose intake + distilled water intake) × 100%. A lower sucrose preference value usually means a more significant anhedonia phenomenon.

[0043] (5) Tail suspension test The tail suspension test is one of the classic methods for evaluating depressive-like behaviors in mice. In the experiment, one-third of the mouse's tail is fixed to the tail suspension apparatus with tape, suspending the mouse in the air. After the mouse adapts for 30 seconds, the time that its four limbs remain stationary within 5 minutes is recorded. The longer the immobility time, the more obvious the animal's despair behavior, reflecting the depression and helplessness of the mouse.

[0044] (6)ELISA experiment Using the enzyme-linked immunosorbent assay method, the contents of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH), and estrogen (E2) in the blood of rats are measured by an ELISA kit. Based on the changes in the contents of each index, the effects of the test drug on the physiological functions of the hypothalamic-pituitary-ovarian axis (HPO axis) are judged, and the operation is carried out according to the kit instructions.

[0045] II. Experimental results 1. Body weight Compared with the blank group, the body weight of the mice in the model group was significantly reduced from the 6th week ( P <0.01); compared with the model group, the body weights of the mice in the positive drug group, the second comparative group, and the test drug group increased from the 6th week ( P <0.05); compared with the first comparative group, the body weight of the mice in the test drug group increased significantly at the 8th week ( P <0.05). See Table 1.

[0046] Table 1 Effects of the test drug on the body weight of PDD mice ( ±s, n = 8)

[0047] Note: Compared with the blank group ** P <0.01, * P <0.05; compared with the model group ## P <0.01, # P <0.05; compared with the first comparative group △ P <0.05.

[0048] 2. Vaginal smear Proestrus: Mainly composed of nucleated epithelial cells. As the proestrus transforms into estrus, the proportion of anuclear keratinized cells gradually increases. Estrus: Mainly anuclear keratinized cells, with irregular shapes and piled up in sheets. Metestrus: A large number of white blood cells and anuclear keratinized epithelial cells, and the white blood cells are round or oval in shape. Diestrus: There are three types of cells, namely nucleated epithelial cells, keratinized cells and white blood cells. As the transformation into proestrus occurs, the number of white blood cells gradually decreases. The vaginal cell smear of the mice in the blank group shows regular changes according to the pattern of proestrus - estrus - metestrus - diestrus, which is one estrous cycle; compared with the blank group, the mice in the experimental group are continuously in diestrus, that is, the estrous cycle is disordered. After the administration treatment in each group is completed, the disorder rate of the estrous cycle of the model mice is significantly reduced ( P <0.01), but there is no statistical difference among the administration groups. See Figure 1 , Table 2.

[0049] Table 2 Effects of the test drugs on the disorder rate of estrous cycle in PDD mice (n = 8)

[0050] Note: Compared with the blank group ** P <0.01; compared with the model group ## P <0.01.

[0051] 3. Open field test Compared with the blank group, the total distance, the time and frequency of entering the central area of the mice in the model group were significantly reduced ( P <0.01); compared with the model group, the total distance, the time and frequency of entering the central area of the mice in the positive drug group, the classical prescription group and the test drug group were significantly increased ( P <0.01 or P <0.05), the time and frequency of entering the central area of the second control group were significantly increased ( P <0.05), but there was no obvious effect on the total activity distance of the mice; compared with the first control group, the time of the test drug group mice entering the central area was significantly increased ( P <0.05). See Figure 2 , Table 3.

[0052] Table 3 Effects of the test drugs on the total distance in the open field and the situation of entering the central area of PPD mice ( ±s, n = 8)

[0053] Note: Compared with the blank group ** P <0.01; compared with the model group ## P <0.01, # P< 0.05; Compared with the first group of control examples △ P < 0.05.

[0054] 4. Elevated plus maze test Compared with the blank group, the ratios of the number of times (OE%) and time (OT%) that the mice in the model group entered the open arms were significantly decreased ( P < 0.01 or P < 0.05); compared with the model group, the OE% and OT% values of the positive drug group, the second group of control examples and the test drug group were significantly increased ( P < 0.01 or P < 0.05), and only the test drug group had significant statistical differences ( P < 0.01), and there were statistical differences in the OT% value of the test drug group compared with the first group of control examples ( P < 0.05). See Figure 3 , see Table 4.

[0055] Table 4 Effects of the test drug on the entry of PDD mice into the open arms ( ±s, n = 8)

[0056] Note: Compared with the blank group ** P < 0.01, * P < 0.05; compared with the model group ## P < 0.01, # P < 0.05; compared with the first group of control examples △ P < 0.05.

[0057] 5. Sucrose preference test and tail suspension test Both the sucrose preference test and the tail suspension test are used to evaluate the depressive-like behaviors of animals, simulating the anhedonia and behavioral despair states of patients with depression respectively. Compared with the blank group, the sucrose preference degree of the mice in the model group was significantly decreased ( P < 0.01), and the immobile time was significantly increased ( P < 0.01); compared with the model group, only the positive drug group and the test drug group had significant reversals in the sucrose preference degree and immobile time (both P < 0.01), and the test drug group was significantly superior to the first group of control examples and the second group of control examples in improving the sucrose preference degree of the model mice ( P < 0.05), showing its good antidepressant potential. See Table 5.

[0058] Table 5 Effects of the test drug on the sucrose preference degree and immobile time of PDD mice ( ±s, n = 8)

[0059] Note: Compared with the blank group ** P <0.01; compared with the model group ## P <0.01, # P <0.05; compared with Comparative Example Group 1 △ P <0.05; compared with Comparative Example Group 2 ▲ P <0.05.

[0060] 6. ELISA experiment Compared with the blank group, the contents of GnRH and LH in the model group of mice were significantly increased ( P <0.01 or P <0.05), and the level of E2 was decreased ( P <0.01); compared with the model group, the trends of the above indexes in the positive drug group and the test drug group were significantly reversed ( P <0.01 or P <0.05), the classical prescription group and the Comparative Example Group 2 could reverse the levels of LH and E2 in the model mice ( P <0.01 or P <0.05), but had no significant effect on GnRH secretion; compared with Comparative Example Group 1, the regulatory effects of the test drug group on LH and E2 were significantly enhanced ( P <0.01 or P <0.05); compared with Comparative Example Group 2, the test drug group significantly increased the secretion of E2 ( P <0.05). See Table 6.

[0061] Table 6 Effects of the test drug on the function of the HPO axis in PDD mice ( ±s, n = 8)

[0062] Note: Compared with the blank group ** P <0.01, * P <0.05; compared with the model group ## P <0.01, # P <0.05; compared with Comparative Example Group 1 △△ P <0.01, △ P <0.05; compared with Comparative Example Group 2, ▲ P <0.05.

[0063] Those of ordinary skill in the art should understand that the discussion of any of the above embodiments is merely exemplary and is not intended to imply that the scope of the present application is limited to these examples; under the concept of the present application, the technical features in the above embodiments or different embodiments can also be combined, the steps can be implemented in any order, and there are many other variations of different aspects of one or more embodiments in the present application as described above, which are not provided in detail for the sake of brevity.

[0064] One or more embodiments of the present application are intended to cover all such substitutions, modifications, and variations that fall within the broad scope of the present application. Therefore, any omissions, modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of one or more embodiments of the present application shall be included within the scope of protection of the present application.

Claims

1. A Chinese medicine composition for treating perimenopausal depression, characterized in that: The invention comprises the following raw material components in parts by weight: 12-17 parts of lily, 12-17 parts of rehmannia root, 8-10 parts of angelica root, 12-17 parts of white peony root, 10-15 parts of poria, 8-10 parts of ligusticum chuanxiong, 10-15 parts of oriental water plantain, 10-15 parts of atractylodes macrocephala, 12-17 parts of polyphylla, 8-10 parts of gardenia, 12-17 parts of floating wheat, 4-8 parts of vinegar-soaked cyperus, 4-8 parts of green plum blossom, 4-8 parts of green peel, 2-4 parts of roasted licorice root, 12-17 parts of jujube and 10-15 parts of curcuma.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention comprises the following raw material components in parts by weight: 14-16 parts of lily, 14-16 parts of rehmannia root, 8-10 parts of angelica root, 14-16 parts of white peony root, 11-13 parts of poria, 8-10 parts of ligusticum chuanxiong, 11-13 parts of orientalism, 11-13 parts of atractylodes macrocephala, 14-16 parts of polyphylla, 8-10 parts of gardenia, 14-16 parts of floating wheat, 5-7 parts of vinegar-soaked cyperus, 5-7 parts of green plum blossom, 5-7 parts of green peel, 2-4 parts of roasted licorice root, 14-16 parts of jujube, and 11-13 parts of curcuma.

3. The Chinese medicine composition as claimed in claim 2, characterized in that: The invention comprises the following raw material components in parts by weight: 15 parts of lily, 15 parts of rehmannia root, 9 parts of angelica root, 15 parts of white peony root, 12 parts of poria, 9 parts of ligusticum chuanxiong, 12 parts of oriental water plantain, 12 parts of atractylodes macrocephala, 15 parts of polyphylla, 9 parts of gardenia, 15 parts of floating wheat, 6 parts of vinegar-soaked cyperus, 6 parts of green plum blossom, 6 parts of green peel, 3 parts of roasted licorice root, 15 parts of jujube and 12 parts of curcuma.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that: The dosage form of the Chinese medicine composition is tablets, capsules, granules, pills or oral liquid.

5. A method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The Chinese medicinal components are mixed, and decocted twice with water, with 8-12 times the amount of water added for the first time and 5-7 times the amount of water added for the second time. The decoctions are combined, filtered, and concentrated to obtain the Chinese medicinal composition.

6. The preparation method according to claim 5, characterized in that: Add 10 times the amount of water the first time and 6 times the amount of water the second time.

7. The preparation method according to claim 5, characterized in that: The first decoction time is 1-2h, and the second decoction time is 0.5-1h.

8. The preparation method according to claim 5, characterized in that: The relative density of the concentrated solution is 1.3-1.

4.

9. A use of the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The traditional Chinese medicine composition is used for preparing medicine for treating perimenopausal depression.

Citation Information

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