A traditional Chinese medicine composition for treating perimenopausal depression, a preparation method and use thereof

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine composition, preparation method, and uses for treating perimenopausal depression. It comprises the following raw material components in parts by weight: 12-17 parts lily bulb, 12-17 parts rehmannia root, 8-10 parts angelica root, 12-17 parts white peony root, 10-15 parts poria cocos, 8-10 parts chuanxiong rhizome, 10-15 parts alisma rhizome, 10-15 parts atractylodes rhizome, 12-17 parts polygonum multiflorum stem, 8-10 parts gardenia fruit, 12-17 parts floating wheat, 4-8 parts vinegar-processed cyperus rhizome, 4-8 parts green plum blossom, 4-8 parts green tangerine peel, 2-4 parts prepared licorice root, 12-17 parts jujube, and 10-15 parts turmeric. This invention can improve the efficacy of treating perimenopausal depression.

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 endocrine environment of the body, 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 symptoms 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 channels are deficient, qi and blood, yin and yang are out of balance, and the functions of zang-fu organs are disordered, resulting in emotional disorders and prone to depression. This disease is based on the kidney and closely related to the liver, and can involve the heart, spleen, stomach and other zang-fu organs; currently, it is generally believed that its pathogenesis is kidney deficiency and liver depression, and the principles and methods of treatment are mainly to tonify the kidney and replenish 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, cynomorium songaricum, curcuma longa, curculigo orchioides, salvia officinalis, polygonum cuspidatum, astragalus membranaceus, bupleurum chinense, ginseng, etc. The main prescriptions are modified lily-rehmannia decoction, minor bupleurum decoction, peach kernel and safflower four-ingredient decoction, kidney-tonifying and liver-soothing formula. 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, and improve the effect of treating 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 - 1,7 parts of lily, 12 - 17 parts of rehmannia root, 8 - 10 parts of angelica sinensis, 12 - 17 parts of white peony root, 10 - 15 parts of poria cocos, 8 - 10 parts of ligusticum wallichii, 10 - 15 parts of alisma orientale, 10 - 15 parts of atractylodes macrocephala, 12 - 17 parts of polygonum multiflorum thunb, 8 - 10 parts of gardenia jasminoides, 12 - 17 parts of floating wheat, 4 - 8 parts of cyperus rotundus, 4 - 8 parts of green plum, 4 - 8 parts of green tangerine peel, 2 - 4 parts of roasted licorice root, 12 - 17 parts of Chinese date, 10 - 15 parts of turmeric root-tuber.

[0006] Preferably, the raw material components include the following parts by weight: 14-16 parts of lily bulb, 14-16 parts of rehmannia root, 8-10 parts of angelica root, 14-16 parts of white peony root, 11-13 parts of poria cocos, 8-10 parts of chuanxiong rhizome, 11-13 parts of alisma rhizome, 11-13 parts of atractylodes rhizome, 14-16 parts of polygonum multiflorum stem, 8-10 parts of gardenia fruit, 14-16 parts of wheat bran, 5-7 parts of vinegar-processed cyperus rhizome, 5-7 parts of green plum blossom, 5-7 parts of green tangerine peel, 2-4 parts of prepared licorice root, 14-16 parts of jujube, and 11-13 parts of turmeric.

[0007] Preferably, the raw material components include the following parts by weight: 15 parts lily bulb, 15 parts rehmannia root, 9 parts angelica root, 15 parts white peony root, 12 parts poria cocos, 9 parts chuanxiong rhizome, 12 parts alisma rhizome, 12 parts atractylodes rhizome, 15 parts polygonum multiflorum stem, 9 parts gardenia fruit, 15 parts floating wheat, 6 parts vinegar-processed cyperus rhizome, 6 parts green plum blossom, 6 parts green tangerine peel, 3 parts prepared licorice root, 15 parts jujube, and 12 parts turmeric.

[0008] Preferably, the dosage form of the traditional Chinese medicine composition is tablets, capsules, granules, pills, or oral liquid.

[0009] This invention provides a method for preparing the traditional Chinese medicine composition, wherein the traditional Chinese medicine components are mixed, decocted twice with water, the first time with 8-12 times the amount of water and the second time with 5-7 times the amount of water, the decoctions are combined, filtered, and concentrated to obtain the traditional Chinese medicine composition.

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

[0011] Preferably, the first decoction time is 1-2 hours, and the second decoction time is 0.5-1 hour.

[0012] Preferably, the relative density of the concentrated drug solution is 1.3-1.4.

[0013] This invention provides an application of the traditional Chinese medicine composition, which is used to prepare a drug for treating perimenopausal depression.

[0014] The beneficial effects of this invention are as follows: lily nourishes yin and moistens the lungs, clears the heart and calms the mind; rehmannia nourishes yin and cools the blood, nourishes yin and generates fluids. The combination of these two herbs can nourish yin and clear heat, tonify the heart and lungs, and improve symptoms such as irritability, mental confusion, insomnia, and excessive dreaming. White peony nourishes blood and softens the liver; angelica replenishes and invigorates blood, assisting peony in nourishing liver blood; chuanxiong promotes the flow of qi in the blood, ensuring smooth blood flow and preventing stagnation; alisma promotes diuresis and eliminates dampness; atractylodes and poria strengthen the spleen and eliminate dampness. The three herbs combined treat the spleen. Sufficient liver blood ensures smooth qi flow, and a healthy spleen eliminates dampness.

[0015] The entire formula works by soothing the liver and relieving depression, regulating qi, nourishing blood and promoting blood circulation, and strengthening the spleen and eliminating dampness. Polygonum multiflorum nourishes the heart and calms the mind, unblocks the meridians and dispels wind; Gardenia jasminoides clears heat and relieves irritability, clears heat and promotes diuresis; Triticum aestivum strengthens qi and consolidates the exterior, nourishes the heart and calms the mind; Cyperus rotundus (processed with vinegar) soothes the liver and relieves depression, regulates menstruation and relieves pain; Prunus mume (green) and Citrus reticulata peel (green) soothe the liver and regulate qi; Curcuma longa (turmeric) promotes blood circulation, relieves pain, regulates qi and relieves depression, clears the heart and cools the blood; Jujube and Glycyrrhiza uralensis (processed) harmonize the properties of the herbs and tonify the middle jiao and replenish qi. The combined effects of these herbs enhance the efficacy of nourishing the heart and calming the mind, soothing the liver and relieving depression, and promoting blood circulation and removing blood stasis.

[0016] This invention adds Polygonum multiflorum, Gardenia jasminoides, Triticum aestivum, Cyperus rotundus (processed with vinegar), Prunus mume, and Citrus reticulata peel to the basic formula of Lily and Rehmannia Decoction combined with Angelica and Peony Powder. Through experiments, it was found that the traditional Chinese medicine composition of this invention, compared with the compositions of comparative examples 1-3, can significantly increase body weight, reduce disorder rate, and increase the time for mice to enter the central zone. The OE% and OT% values ​​are significantly increased, and the sucrose preference of model mice can be significantly improved. The regulatory effects on LH and E2 are significantly enhanced, indicating that it has a good therapeutic effect on perimenopausal depression. Attached Figure Description

[0017] Figure 1 Examples of mouse vaginal exfoliated cell smear results at different stages (20×); where (A) is proestrus, (B) is estrus, (C) is metestrus, and (D) is estrus.

[0018] Figure 2 The open field trajectory diagrams for each group of mice are shown.

[0019] Figure 3 The trajectory diagrams for the elevated cross maze experiment of mice in each group are shown. Detailed Implementation

[0020] Example 1

[0021] A traditional Chinese medicine composition for treating perimenopausal depression comprises the following herbal components in parts by weight: 15g lily bulb, 15g rehmannia root, 9g angelica root, 15g white peony root, 12g poria cocos, 9g chuanxiong rhizome, 12g alisma rhizome, 12g atractylodes rhizome, 15g polygonum multiflorum stem, 9g gardenia fruit, 15g wheat bran, 6g vinegar-processed cyperus rhizome, 6g green plum blossom, 6g green tangerine peel, 3g prepared licorice root, 15g jujube, and 12g turmeric.

[0022] The method for preparing the traditional Chinese medicine composition for treating perimenopausal depression is as follows: mix the above-mentioned traditional Chinese medicine components, add water and decoct twice. For the first decoction, add 10 times the amount of water and decoct for 2 hours. For the second decoction, 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.

[0023] Comparative Example 1

[0024] Compared with Example 1, the difference lies in the inclusion of the following herbal components by weight: lily bulb 28g, rehmannia root 28g, angelica root 17g, white peony root 28g, poria cocos 23g, chuanxiong rhizome 17g, alisma rhizome 22g, and atractylodes rhizome 23g. Everything else is the same as in Example 1.

[0025] Comparative Example 2

[0026] Compared with Example 1, the difference lies in the inclusion of the following herbal components by weight: 15g lily bulb, 15g rehmannia root, 9g angelica root, 15g white peony root, 12g poria cocos, 9g chuanxiong rhizome, 12g alisma rhizome, 12g atractylodes rhizome, 15g polygala root, 9g gardenia fruit, 15g albizia flower, 6g poria cocos sclerotium, 6g prepared epimedium root, 6g immature bitter orange fruit, 3g prepared licorice root, 15g jujube, and 12g turmeric. All other components are the same as in Example 1.

[0027] Comparative Example 3

[0028] Compared with Example 1, the difference lies in the inclusion of the following herbal components by weight: lily bulb 28g, rehmannia root 28g, angelica root 17g, white peony root 28g, poria cocos 23g, chuanxiong rhizome 17g, alisma rhizome 23g, and atractylodes rhizome 22g. Everything else is the same as in Example 1. Comparative Example 3 consists of Lily Bulb and Rehmannia Decoction combined with Angelica and Peony Root Powder, representing a classical formula combination.

[0029] Example 2

[0030] 1. Laboratory animals

[0031] C57BL / 6 mice, female, 8 weeks old, 18-22g, 56 mice, were purchased from Hunan Slack Jingda Experimental Animal Co., Ltd.

[0032] 2. Drugs

[0033] The compound prescription for the tested traditional Chinese medicine group is shown in Example 1. Comparative examples 1-3 are shown in Comparative examples 1-3.

[0034] Positive drug: Flupentixol and melitracen tablets, purchased from Lundbeck Pharmaceuticals Ltd., Denmark, approval number H20171104, specifications: Flupentixol 0.5mg and melitracen 10mg / tablet × 20 tablets.

[0035] 3. Grouping and modeling

[0036] After purchase, animals were acclimatized for 5 days. A saccharide preference test was used to assess baseline depressive behavior in each animal. Based on saccharide preference, animals were randomly divided into 7 groups: 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 traditional Chinese medicine group), and an example 1 group (i.e., the test drug group), with 8 animals in each group. Except for the blank control group, all other mice underwent ovariectomy (OVX) combined with chronic unpredictable stress (CUS) to establish a perimenopausal depression (PDD) animal model. Mice were anesthetized by intraperitoneal injection of 2% sodium pentobarbital (60 mg / kg). Bilateral longitudinal incisions were made approximately 1 cm laterally along the lower third of the trunk and on both sides of the spine. The fat pads were separated, and both ovaries were ligated and removed, completing castration. The incisions were sutured after surgery. In the blank control group, the abdominal cavity was opened under anesthesia, and adipose tissue equivalent to the volume of the ovary was removed before suturing the incision. Postoperatively, penicillin was injected into the thigh muscle to prevent infection. After the surgery, vaginal smears of mice were examined for 5 consecutive days. If no estrous cycle was observed for 5 consecutive days, the castration was considered successful.

[0037] Continue to provide CUS with 6 weeks of modeling support, including the following methods:

[0038] Swimming in 4℃ cold water for 5 minutes: Simulates cold water stress, lasting for 5 minutes.

[0039] Tail clamping for 1 minute: An acute stress response was induced by clamping the tail of a mouse for 1 minute.

[0040] Moist bedding for 24 hours: Placing mice in a moist environment for 24 hours increases environmental stress.

[0041] Reversing day and night for 24 hours: altering the circadian rhythm in mice to simulate a disruption of their biological clock.

[0042] Restraint for 6 hours: Mice were fixed in a confined space for 6 hours to induce a stress response.

[0043] Fasting and water restriction for 24 hours: Depriving people of food and water for 24 hours causes physiological stress.

[0044] Foot shock (2 mA, 1 s / time, 10 times / min) for 2 minutes: Electric shocks were used to stimulate the plantar nerves of mice to produce pain and stress.

[0045] 90dB noise for 4 hours: Continuous noise interference for 4 hours to simulate the stress effect of noise pollution.

[0046] A different stress method is randomly applied each day, and the same stress method is not used consecutively, to ensure the diversity and randomness of stress and avoid adaptation caused by a single stress method.

[0047] 4. Animal administration

[0048] On day 1 of CUS modeling, the drugs were administered by gavage. The positive control group was given flupentixol melitracen tablets at a dose of 2.73 mg / kg / day (the adult daily dose is 21 mg, which is the clinically equivalent dose). The Example 1 and Comparative Examples 1-3 groups were given the corresponding drugs at 8.06 g / kg / day (1 / 3 of the clinically equivalent dose). The blank control group and the model group were given an equal volume of distilled water at a dose of 20 mL / kg.

[0049] 5. Indicator Testing

[0050] (1) Weight

[0051] Mice in each group were weighed weekly at regular intervals, and their weight changes were recorded.

[0052] (2) Open field experiment

[0053] The open field test is used to assess the activity, exploratory behavior, and anxiety / depression levels of mice in a new environment. Mice are placed in a dark, open test chamber, and their spontaneous activity is observed. The total distance traveled, the time spent in the central region, and the distance traveled in the central region are recorded over 5 minutes. Mice with higher anxiety levels spend less time in the central region and travel shorter distances, exhibiting more peripheral activity, while animals with higher depression levels also show a significantly reduced total distance traveled.

[0054] (3) Elevated cross maze experiment

[0055] The elevated cross maze test is used to assess anxiety behavior in mice. In the experiment, the number of times mice entered open and closed arms within 5 minutes, as well as the time spent in open arms, were recorded. The open-arms entry percentage (OE) was calculated as (number of open arm entries / (number of open arm entries + number of closed arm entries)) × 100%; the open-arms time percentage (OT) was calculated as (open arm time / (open arm time + closed arm time)) × 100%. Mice with higher anxiety levels typically entered open arms less frequently and spent less time in them, exhibiting stronger avoidance behavior.

[0056] (4) Sugar water preference experiment

[0057] The sucrose preference test is used to assess the degree of anhedonia in mice and is one of the most classic behavioral indicators for evaluating the efficacy of drugs in animal models of depression. In the experiment, two bottles, one containing 2% sucrose solution and the other containing distilled water, are placed at the mice's drinking water outlets, allowing them to choose freely. The amount of sucrose solution and distilled water consumed over a certain period is recorded, and the sucrose preference value is calculated using the formula: Sucrose preference value = (Sucrose intake / (Sucrose intake + Distilled water intake)) × 100%. A low sucrose preference value usually indicates a significant anhedonia.

[0058] (5) Tail suspension test

[0059] The tail suspension test is a classic method for assessing depressive-like behavior in mice. In this test, the mouse's tail is taped to a tail suspension device, suspending the mouse in the air. After the mouse adapts for 30 seconds, the time it remains motionless for 5 minutes is recorded. A longer period of stillness indicates more pronounced hopeless behavior, reflecting the mouse's depression and helplessness.

[0060] (6) ELISA experiment

[0061] The levels of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH), and estrogen (E2) in rat serum were measured using an enzyme-linked immunosorbent assay (ELISA) kit. The effects of the test drug on the physiological function of the hypothalamus-pituitary-ovarian axis (HPO axis) were determined based on changes in the levels of each indicator. The procedure was performed in accordance with the kit instructions.

[0062] II. Experimental Results

[0063] 1. Weight

[0064] Compared with the control group, the body weight of mice in the model group decreased significantly from week 6 onwards. P <0.01); Compared with the model group, mice in the positive drug group, comparative group II, and test drug group gained weight from week 6 onwards ( P <0.05); compared with the control group, the mice in the test drug group had a significant increase in body weight at week 8 ( P <0.05). See Table 1.

[0065] Table 1. Effects of the test drug on the body weight of PDD mice ( ±s, n=8)

[0066]

[0067] 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 comparative example group △ P <0.05.

[0068] 2. Vaginal smear

[0069] Proestrus: Predominantly composed of nucleated epithelial cells. As proestrus transitions to estrus, the proportion of anucleated keratinocytes gradually increases. Estrus: Mainly composed of anucleated keratinocytes, irregularly shaped and clustered in sheets. Mesentery: Abundant leukocytes and anucleated keratinocytes; leukocytes are round or oval in shape. Diestrus: Nucleated epithelial cells, keratinocytes, and leukocytes coexist; as proestrus continues, the number of leukocytes gradually decreases. Vaginal cell smears from the control group mice showed a pattern of proestrus—estrus—metaestrus—diestrus, constituting one estrous cycle. Compared to the control group, the experimental group mice remained continuously in the diestrus phase, indicating estrous cycle disorder. After treatment in each group, the rate of estrous cycle disorder in the model mice was significantly reduced. P <0.01), but there was no statistically significant difference between the different treatment groups. See Figure 1 See Table 2.

[0070] Table 2. Effects of the test drug on the estrous cycle disorder rate in PDD mice (n=8)

[0071]

[0072] Note: Compared with the blank group** P <0.01; compared with the model group ## P <0.01.

[0073] 3. Open field experiment

[0074] Compared with the control group, the total distance traveled, the time to enter the central area, and the number of times were all significantly reduced in the model group mice. P <0.01); Compared with the model group, the total distance traveled, the time to enter the central area, and the number of times mice in the positive drug group, the traditional Chinese medicine group, and the test drug group were all significantly increased ( P <0.01 or P <0.05, the time and frequency of entering the central area in the second comparative group increased significantly ( P <0.05), but had no significant effect on the total distance traveled by mice; compared with the control group, the time for mice in the test drug group to enter the central area was significantly increased ( P <0.05). See Figure 2 See Table 3.

[0075] Table 3. Effects of the test drug on the total open field distance and entry into the central region in PPD mice ( ±s, n=8)

[0076]

[0077] Note: Compared with the blank group** P <0.01; compared with the model group ## P <0.01, # P <0.05; compared with the comparative example group △ P <0.05.

[0078] 4. Elevated Cross Maze Experiment

[0079] Compared with the control group, the model group mice showed a significantly lower rate of entry into the open arm (OE%) and a significantly lower time to enter (OT%). P <0.01 or P <0.05; compared with the model group, the OE% and OT% values ​​of the positive drug group, the control group II, and the test drug group were significantly increased ( P <0.01 or P <0.05, with only the test drug group showing a statistically significant difference ( P <0.01, and the OT% value of the test drug group was statistically different from that of the control group ( P <0.05). See Figure 3 See Table 4.

[0080] Table 4. Effects of the test drug on the entry of PDD mice into open arms ( ±s, n=8)

[0081]

[0082] 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 comparative example group △ P <0.05.

[0083] 5. Sugar water preference test and tail suspension test

[0084] Both the sucrose preference test and the tail suspension test were used to evaluate depressive-like behaviors in animals, simulating anhedonia and behavioral despair in patients with depression, respectively. Compared with the control group, the model group mice showed a significantly reduced sucrose preference ( P <0.01), the immobility time increased significantly ( P<0.01); compared with the model group, only the sucrose preference and immobility time were significantly reversed in the positive drug group and the test drug group (both <0.01). P <0.01, and the test drug group was significantly better than the control group 1 and control group 2 in improving the sucrose preference of model mice. P <0.05), demonstrating its good antidepressant potential. See Table 5.

[0085] Table 5. Effects of the test drug on sucrose preference and immobility time in PDD mice ( ±s, n=8)

[0086]

[0087] Note: Compared with the blank group** P <0.01; compared with the model group ## P <0.01, # P <0.05; compared with the comparative example group △ P <0.05; compared with the second comparative example group ▲ P <0.05.

[0088] 6. ELISA experiment

[0089] Compared with the control group, the GnRH and LH levels in the model group mice were significantly increased. P <0.01 or P <0.05, E2 level decreased ( P <0.01); compared with the model group, only the trends of the above indicators in the positive drug group and the test drug group were significantly reversed ( P <0.01 or P <0.05%, the classical formula group and the control group were able to reverse the LH and E2 levels in the model mice ( P <0.01 or P <0.05), but had no significant effect on GnRH secretion; compared with the control group, the test drug group showed a significantly enhanced regulatory effect on LH and E2 ( P <0.01 or P <0.05); compared with control group 2, the test drug group significantly increased E2 secretion ( P <0.05). See Table 6.

[0090] Table 6. Effects of the test drug on HPO axis function in PDD mice ( ±s, n=8)

[0091]

[0092] 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 comparative example group △△ P <0.01, △ P <0.05; compared with the second comparative example, ▲ P <0.05.

[0093] Those skilled 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 protection of this application is limited to these examples; within the framework of this application, the technical features of 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 of this application as described above, which are not provided in detail for the sake of brevity.

[0094] One or more embodiments in this application are intended to cover all such substitutions, modifications, and variations that fall within the broad scope of this application. Therefore, any omissions, modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of one or more embodiments in this application should be included within the protection scope of this application.

Claims

1. A traditional Chinese medicine composition for treating perimenopausal depression, characterized in that, It is composed of the following raw materials in parts by weight: 15 parts lily bulb, 15 parts rehmannia root, 9 parts angelica root, 15 parts white peony root, 12 parts poria cocos, 9 parts chuanxiong rhizome, 12 parts alisma rhizome, 12 parts atractylodes rhizome, 15 parts polygonum multiflorum stem, 9 parts gardenia fruit, 15 parts floating wheat, 6 parts vinegar-processed cyperus rhizome, 6 parts green plum blossom, 6 parts green tangerine peel, 3 parts prepared licorice root, 15 parts jujube, and 12 parts turmeric. ​ 2. The traditional Chinese medicine composition as described in claim 1, characterized in that, The dosage form of the traditional Chinese medicine composition is tablets, capsules, granules, pills, or oral liquid.

3. A method for preparing the traditional Chinese medicine composition as described in claim 1 or 2, characterized in that, The herbal components are mixed and decocted twice with water. The first decoction is 8-12 times the amount of water, and the second decoction is 5-7 times the amount of water. The decoctions are combined, filtered, and concentrated to obtain the herbal composition.

4. The preparation method according to claim 3, characterized in that, Add 10 times the amount of water the first time, and 6 times the amount of water the second time.

5. The preparation method according to claim 3, characterized in that, The first decoction should be done for 1-2 hours, and the second decoction should be done for 0.5-1 hour.

6. The preparation method according to claim 3, characterized in that, The relative density of the concentrated medicine solution is 1.3-1.

4.

7. The use of the traditional Chinese medicine composition as described in claim 1 or 2, characterized in that, The traditional Chinese medicine composition is used to prepare a drug for treating perimenopausal depression.

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