Traditional Chinese medicine composition for regulating qi and relieving depression, traditional Chinese medicine preparation and application

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and provides a traditional Chinese medicine composition for regulating qi and relieving depression, a traditional Chinese medicine preparation and application. The traditional Chinese medicine composition is prepared from the following components in parts by weight: 9 to 11 parts of radix bupleuri, 9 to 11 parts of rhizoma cyperi, 9 to 11 parts of fructus aurantii, 9 to 11 parts of pericarpium citri reticulatae, 9 to 11 parts of rhizoma chuanxiong, 15 to 20 parts of radix paeoniae alba, 4 to 6 parts of liquorice root, 16 to 20 parts of radix curcumae and 9 to 11 parts of flos inulae. The composition has the effects of soothing liver and regulating qi, and resolving depression and tonifying spleen, and can be widely applied to relieving and treating the symptoms such as hypochondriac pain, chest distress, fit, emotion depression, irritability or belching, abdominal fullness and distention and the like caused by liver depression and qi stagnation.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and provides a traditional Chinese medicine composition, a traditional Chinese medicine preparation and an application for regulating qi and relieving depression. Background Art

[0002] Depression is a common psychological disorder. Commonly used drugs in Western medicine for the treatment of depression, such as escitalopram, venlafaxine, duloxetine, etc., can cause damage to the liver and kidneys when taken for a long time. Traditional Chinese medicine believes that depression is a pathogenesis of qi stagnation and brain spirit malnutrition caused by factors such as emotional injury, improper diet, overwork, and imbalance of zang-fu functions, belonging to the category of "depression syndrome", and its etiology and pathogenesis are mostly related to factors such as emotional injury, liver qi stagnation, and heart-spleen deficiency.

[0003] However, there are many varieties of traditional Chinese medicines, such as Jieyu Pills, Jiaotong Xinshen Capsules, Shugan Jieyu Capsules, Chaihu Yujin Decoction, etc., but their respective effects are different.

[0004] For example, Chaihu Yujin Decoction is a prescription made mainly of bupleurum and turmeric, and there are various different prescriptions. Among them, the prescription with 10 grams each of bupleurum, fructus aurantii, white peony root, cyperus rotundus, and turmeric, 6 grams each of tangerine peel, green tangerine peel, and inula britannica (decocted in a package), and 3 grams of licorice has the effect of soothing the liver and regulating the stomach, and is applicable to those with belching caused by anger and depression injuring the liver, liver qi invading the stomach, and stomach qi ascending rebelliously. And the prescription with 10g of bupleurum, 10g of turmeric, 15g of prunella vulgaris, 10g of seaweed, 30g of raw oyster, 15g of Dioscorea bulbifera, 10g of pinellia ternata (prepared), 30g of scutellaria barbata, 20g of bolbostemma paniculatum, 15g of Paris polyphylla, 10g each of green tangerine peel and tangerine peel, and 30g of cat's claw grass is applicable to liver depression with phlegm dampness.

[0005] It is stated in the analysis of the prescription in "Medical Prescriptions Theory" that "in all depression diseases, qi disease must come first. Once qi is dredged, how can there be depression?", which fully illustrates the pathogenesis status of liver qi stagnation in depression. The existing Chaihu Yujin Decoction still needs to be improved in terms of soothe the liver and regulate qi.

[0006] Chinese Patent Application CN104758813A discloses a traditional Chinese medicine composition for treating gastric and duodenal ulcers of liver qi invading the stomach type, which is composed of the following raw materials in parts by weight: 3 - 11 parts of bupleurum, 3 - 11 parts of fructus aurantii, 28 - 36 parts of paeonia lactiflora, 1 - 9 parts of licorice, 5 - 13 parts of cyperus rotundus, 2 - 10 parts of chuanxiong, 20 - 28 parts of white peony root, 2 - 十个 parts of turmeric, 2 - 10 parts of licorice, 20 - 28 parts of kumquat root. However, it mainly treats epigastric pain and has limited improvement effect on the depression caused by liver qi stagnation.

[0007] Therefore, it is necessary to further improve the traditional Chinese medicine prescriptions of the existing technology to further enhance the therapeutic effects such as soothe the liver and regulate the stomach, relieve depression and strengthen the spleen. Summary of the Invention

[0008] In view of the problems existing in the prior art, the present invention provides a traditional Chinese medicine composition for regulating qi and relieving depression. The composition has significant effects in soothing the liver and regulating qi, relieving depression and strengthening the spleen. It can be used for hypochondriac pain, chest tightness, frequent sighing, emotional depression, irritability or belching, and abdominal distension caused by liver qi stagnation.

[0009] The technical solution of the present invention is as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for regulating qi and relieving depression, wherein the traditional Chinese medicine composition comprises, by weight parts: 9-11 parts of Bupleurum chinense, 9-11 parts of Cyperus rotundus, 9-11 parts of Citrus aurantium, 9-11 parts of Citrus reticulata peel, 9-11 parts of Ligusticum chuanxiong, 15-20 parts of Paeonia lactiflora, 4-6 parts of Glycyrrhiza uralensis, 15-20 parts of Curcuma longa and 9-11 parts of Inula japonica.

[0010] Preferably, the traditional Chinese medicine composition comprises, by weight parts: 9-10 parts Bupleurum, 9-10 parts Cyperus rotundus, 9-10 parts Citrus aurantium, 9-10 parts Citrus reticulata peel, 9-10 parts Ligusticum chuanxiong, 17-18 parts Paeonia lactiflora, 4.5-5.5 parts Glycyrrhiza uralensis, 17-18 parts Curcuma longa, and 9-10 parts Inula japonica.

[0011] More preferably, the traditional Chinese medicine composition comprises, by weight parts: 10 parts Bupleurum, 10 parts Cyperus, 10 parts Citrus aurantium, 10 parts Citrus reticulata peel, 10 parts Ligusticum chuanxiong, 17.5 parts Paeonia lactiflora, 5 parts Glycyrrhiza uralensis, 17.5 parts Curcuma longa and 10 parts Inula japonica.

[0012] This formula uses Bupleurum as the chief herb, taking advantage of its ability to "soothe the liver and relieve depression, and harmonize the lesser yang" (Shennong's Classic of Materia Medica). It regulates liver qi, unblocks stagnation, and directly addresses the root cause of liver qi stagnation.

[0013] The three herbs, Cyperus rotundus ("regulates qi and relieves depression, and unblocks the three jiaos" (Compendium of Materia Medica), Citrus aurantium ("breaks qi and relieves chest congestion, eliminates stagnation and promotes digestion" (Treatise on the Nature of Medicinal Herbs)), and Citrus reticulata ("regulates qi and strengthens the spleen, dries dampness and resolves phlegm" (Essentials of Materia Medica), work together to soothe the liver and regulate qi, harmonize the middle jiao, and help Bupleurum chinense relieve depression and disperse stagnation.

[0014] The adjuvant herbs are divided into three groups: Chuanxiong (Ligusticum striatum) "invigorates blood and qi, relieves depression and pain" (Rihuazi Materia Medica), when combined with Xiangfu (Cyperus rotundus) to invigorate blood and qi, and treat pain in the hypochondrium; Baishao (Paeonia lactiflora) "softens the liver and relieves spasms, nourishes blood and astringes yin" (Shennong's Classic of Materia Medica), when combined with Gancao (Paeonia lactiflora and Gancao Decoction) to transform yin into sour and sweet, relieve spasms and pain; Yujin (Curcuma longa) "invigorates qi and relieves depression, clears the heart and cools the blood" (Compendium of Materia Medica), which not only assists Chaihu (Bupleurum chinense) in soothing the liver, but also relieves the restlessness caused by depression and heat disturbing the heart; Xuanfuhua (Inula japonica) "descends qi and resolves phlegm, and clears the chest and diaphragm" (Mingyi Bielu), which descends rebellious qi to stop belching and relieve epigastric fullness.

[0015] Licorice is used as a medicinal ingredient to "harmonize all the herbs, replenish the middle and boost qi" (from "Ben Cao Zheng"), and also to relieve urgency and harmonize the middle.

[0016] The entire formula uses Bupleurum as the chief herb to soothe the liver, Cyperus rotundus, Citrus aurantium, and Citrus reticulata as the assistant herbs to regulate qi, Ligusticum chuanxiong, Paeonia lactiflora, Curcuma longa, and Inula japonica as adjuvant herbs to invigorate blood, soothe the liver, and resolve phlegm, and Glycyrrhiza uralensis as the guiding herb to harmonize the body. Together, they achieve the effects of soothing the liver and regulating qi to relieve depression, and regulating the middle jiao and resolving phlegm to strengthen the spleen. When the qi flows smoothly, the pain in the hypochondrium disappears, and when the stagnation is dispersed, the emotions are harmonized.

[0017] In some preferred embodiments of the present invention, the mass ratio of Cyperus rotundus, Citrus aurantium, and Citrus reticulata peel is 1:1-1.2:1-1.2. In some preferred embodiments of the present invention, the mass ratio of Ligusticum chuanxiong to Paeonia lactiflora is 1:1.5-1.8.

[0018] In some specific embodiments of the present invention, the traditional Chinese medicine composition is prepared by the following steps: take Bupleurum chinense, Cyperus rotundus, Citrus aurantium, Citrus reticulata peel, Ligusticum chuanxiong, Paeonia lactiflora, Glycyrrhiza uralensis, Curcuma longa and Inula japonica, pulverize them and mix them evenly to obtain the final product.

[0019] In some other specific embodiments of the present invention, the traditional Chinese medicine composition is prepared by the following steps: take Bupleurum chinense, Cyperus rotundus, Citrus aurantium, Citrus reticulata, Ligusticum chuanxiong, Paeonia lactiflora, Glycyrrhiza uralensis, Curcuma longa and Inula japonica, pulverize them, add them to water and decoct them. The decoction is then filtered and concentrated to obtain the final product.

[0020] Furthermore, the decoction is performed 2-3 times, with 3-6 times the amount of water added each time, and the extraction is carried out for 1-2 hours.

[0021] In some more specific embodiments of the present invention, the decoction is performed twice, wherein the first decoction is performed with 6 times the amount of water and decocted for 1.5 hours; the second decoction is performed with 4 times the amount of water and decocted for 1.5 hours.

[0022] Secondly, the present invention also provides a traditional Chinese medicine preparation comprising any of the above-described traditional Chinese medicine compositions, wherein the traditional Chinese medicine preparation is made solely from the traditional Chinese medicine composition, or is made from the traditional Chinese medicine composition and a pharmaceutically acceptable carrier.

[0023] In some embodiments of the present invention, the carrier includes one or more of dextrin, starch, lactose, microcrystalline cellulose, and powdered sugar.

[0024] In some embodiments of the present invention, the traditional Chinese medicine preparation is prepared by the following steps: the traditional Chinese medicine composition and dextrin are mixed to form a soft material, which is then granulated, dried and sorted to obtain the final product.

[0025] Thirdly, the present invention also provides the application of any of the above-described traditional Chinese medicine compositions and preparations in the preparation of antidepressant drugs.

[0026] Furthermore, the dosage form of the antidepressant is any one of granules, tablets, capsules, pills, ointments, powders, decoctions, and oral solutions.

[0027] Compared with the prior art, the present invention has the following beneficial effects: The composition of this invention uses Bupleurum chinense as the chief ingredient to soothe the liver, Cyperus rotundus, Citrus aurantium, and Citrus reticulata as the assistant ingredients to regulate qi, Ligusticum chuanxiong, Paeonia lactiflora, Curcuma longa, and Inula japonica as adjuvant ingredients to invigorate blood, soften the liver, and resolve phlegm, and Glycyrrhiza uralensis as the guiding ingredient to harmonize the body. Together, they achieve the effects of soothing the liver and regulating qi to relieve depression, and regulating the middle jiao to strengthen the spleen. When qi flows smoothly, hypochondriac pain disappears, and when stagnation dissipates, emotions are harmonized. The entire formula is rationally formulated and has the effects of soothing the liver and regulating qi, relieving depression, and strengthening the spleen. It is used for hypochondriac pain, chest tightness, frequent sighing, emotional depression, irritability, belching, and abdominal distension caused by liver qi stagnation. Detailed Implementation

[0028] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0029] Example 1 A traditional Chinese medicine composition for regulating qi and relieving depression, with the following raw material composition: Bupleurum 10 parts, Cyperus rotundus 10 parts, Citrus aurantium 10 parts, Citrus reticulata 10 parts, Ligusticum chuanxiong 10 parts, Paeonia lactiflora 17.5 parts, Glycyrrhiza uralensis 5 parts, Curcuma longa 17.5 parts, and Inula japonica 10 parts.

[0030] The preparation method is as follows: (1) Weigh each raw material according to the prescription amount, crush and sieve it and put it into the extraction tank. Add 6 times the amount of water for the first time and decoct for 1.5 hours. After filtration, add 4 times the amount of water to the residue and continue to decoct for 1.5 hours. After filtration, combine the filtrates. Filter through a 100-mesh sieve to obtain the extract. (2) The extract was concentrated under reduced pressure (vacuum degree -0.06~-0.08MPa) to a relative density of 1.20-1.25g / cm³. 3 (60℃) to obtain the extract of the traditional Chinese medicine composition.

[0031] Example 2 A traditional Chinese medicine composition for regulating qi and relieving depression, with the following raw material composition: Bupleurum chinense 9 parts, Cyperus rotundus 11 parts, Citrus aurantium 11 parts, Citrus reticulata 11 parts, Ligusticum chuanxiong 10 parts, Paeonia lactiflora 17 parts, Glycyrrhiza uralensis 4.5 parts, Curcuma longa 17 parts, and Inula japonica 10 parts.

[0032] The preparation method is the same as in Example 1.

[0033] Example 3 A traditional Chinese medicine composition for regulating qi and relieving depression, with the following raw material composition: Bupleurum 10 parts, Cyperus rotundus 10 parts, Citrus aurantium 10 parts, Citrus reticulata 10 parts, Ligusticum chuanxiong 10 parts, Paeonia lactiflora 18 parts, Glycyrrhiza uralensis 5.5 parts, Curcuma longa 18 parts, and Inula japonica 10 parts.

[0034] The preparation method is the same as in Example 1.

[0035] Example 4 Bupleurum chinense 10 parts, Cyperus rotundus 10 parts, Citrus aurantium 10 parts, Citrus reticulata 10 parts, Ligusticum chuanxiong 9.5 parts, Paeonia lactiflora 18 parts, Glycyrrhiza uralensis 5 parts, Curcuma longa 17.5 parts, and Inula japonica 10 parts.

[0036] The preparation method is the same as in Example 1.

[0037] Example 5 A traditional Chinese medicine composition for regulating qi and relieving depression, with the following raw material composition: Bupleurum chinense 9 parts, Cyperus rotundus 11 parts, Citrus aurantium 11 parts, Citrus reticulata 11 parts, Ligusticum chuanxiong 11 parts, Paeonia lactiflora 20 parts, Glycyrrhiza uralensis 6 parts, Curcuma longa 20 parts, and Inula japonica 11 parts.

[0038] The preparation method is as follows: (1) Weigh each raw material according to the prescription, crush and sieve it and put it into the extraction tank. Add 5 times the amount of water for the first time and decoct for 2 hours. After filtration, add 3 times the amount of water to the residue and continue to decoct for 2 hours. After filtration, combine the filtrates. Filter through a 100-mesh sieve to obtain the extract. (2) The extract was concentrated under reduced pressure (vacuum degree -0.06~-0.08MPa) to a relative density of 1.20-1.25g / cm³. 3 (60℃) to obtain the extract of the traditional Chinese medicine composition.

[0039] Example 6 A traditional Chinese medicine composition for regulating qi and relieving depression, with the following raw material composition: Bupleurum 11 parts, Cyperus rotundus 9 parts, Citrus aurantium 9 parts, Citrus reticulata 9 parts, Ligusticum chuanxiong 9 parts, Paeonia lactiflora 15 parts, Glycyrrhiza uralensis 4 parts, Curcuma longa 15 parts, and Inula japonica 9 parts.

[0040] The preparation method is as follows: (1) Weigh each raw material according to the prescription amount, crush and sieve it and put it into the extraction tank. Add 6 times the amount of water for the first time and decoct for 1 hour. After filtration, add 4 times the amount of water to the residue and continue to decoct for 1 hour. After filtration, combine the filtrates. Filter through a 100-mesh sieve to obtain the extract. (2) The extract was concentrated under reduced pressure (vacuum degree -0.06~-0.08MPa) to a relative density of 1.20-1.25g / cm³. 3 (60℃) to obtain the extract of the traditional Chinese medicine composition.

[0041] Example 7 A traditional Chinese medicine composition for regulating qi and relieving depression, with the following raw material composition: Bupleurum 10 parts, Cyperus rotundus 11 parts, Citrus aurantium 9.5 parts, Citrus reticulata 9.5 parts, Ligusticum chuanxiong 10 parts, Paeonia lactiflora 17.5 parts, Glycyrrhiza uralensis 5 parts, Curcuma longa 17.5 parts, and Inula japonica 10 parts.

[0042] The preparation method is the same as in Example 1.

[0043] Comparative Example 1 A traditional Chinese medicine composition for regulating qi and relieving depression, with the following raw material composition: Bupleurum 10 parts, Cyperus rotundus 10 parts, Citrus aurantium 10 parts, Citrus reticulata 6 parts, Citrus reticulata 6 parts, Paeonia lactiflora 10 parts, Glycyrrhiza uralensis 3 parts, Curcuma longa 10 parts, and Inula japonica 6 parts.

[0044] The preparation method is the same as in Example 1.

[0045] Comparative Example 2 Bupleurum chinense 5 parts, Cyperus rotundus 5 parts, Citrus aurantium 5 parts, Ligusticum chuanxiong 5 parts, Paeonia lactiflora 28 parts, Paeonia lactiflora 20 parts, Glycyrrhiza uralensis 2.5 parts, Curcuma longa 8.5 parts, and Citrus reticulata root 20 parts.

[0046] Bupleurum 10 parts, Cyperus rotundus 10 parts, Citrus aurantium 10 parts, Citrus reticulata 10 parts, Citrus reticulata 10 parts, Paeonia lactiflora 17.5 parts, Glycyrrhiza uralensis 5 parts, Curcuma longa 17.5 parts, and Inula japonica 10 parts.

[0047] The preparation method is the same as in Example 1.

[0048] Comparative Example 3 Bupleurum 10 parts, Cyperus rotundus 10 parts, Citrus aurantium 10 parts, Citrus reticulata root 10 parts, Ligusticum chuanxiong 10 parts, Paeonia lactiflora 17.5 parts, Glycyrrhiza uralensis 5 parts, Curcuma longa 17.5 parts, and Inula japonica 10 parts.

[0049] The preparation method is the same as in Example 1.

[0050] Comparative Example 4 Bupleurum 10 parts, Cyperus rotundus 10 parts, Citrus aurantium 10 parts, Citrus reticulata 10 parts, Ligusticum chuanxiong 10 parts, Paeonia lactiflora 17.5 parts, Glycyrrhiza uralensis 5 parts, Curcuma longa 17.5 parts, and Paeonia lactiflora 10 parts.

[0051] The preparation method is the same as in Example 1.

[0052] Comparative Example 5 Bupleurum 10 parts, Cyperus rotundus 11.5 parts, Citrus aurantium 11.5 parts, Citrus reticulata 7 parts, Ligusticum chuanxiong 10 parts, Paeonia lactiflora 17.5 parts, Glycyrrhiza uralensis 5 parts, Curcuma longa 17.5 parts, and Inula japonica 10 parts.

[0053] The preparation method is the same as in Example 1.

[0054] Comparative Example 6 Bupleurum chinense 10 parts, Cyperus rotundus 8.5 parts, Citrus aurantium 10.75 parts, Citrus reticulata 10.75 parts, Ligusticum chuanxiong 10 parts, Paeonia lactiflora 17.5 parts, Glycyrrhiza uralensis 5 parts, Curcuma longa 17.5 parts, and Inula japonica 10 parts.

[0055] The preparation method is the same as in Example 1.

[0056] Comparative Example 7 Bupleurum 10 parts, Cyperus rotundus 10 parts, Citrus aurantium 10 parts, Citrus reticulata 10 parts, Ligusticum chuanxiong 22 parts, Paeonia lactiflora 5.5 parts, Glycyrrhiza uralensis 5 parts, Curcuma longa 17.5 parts, and Inula japonica 10 parts.

[0057] The preparation method is the same as in Example 1.

[0058] Comparative Example 8 Bupleurum 10 parts, Cyperus rotundus 10 parts, Citrus aurantium 10 parts, Citrus reticulata 10 parts, Ligusticum chuanxiong 15 parts, Paeonia lactiflora 12.5 parts, Glycyrrhiza uralensis 5 parts, Curcuma longa 17.5 parts, and Inula japonica 10 parts.

[0059] The preparation method is the same as in Example 1.

[0060] I. Pharmacodynamic experiments of the traditional Chinese medicine preparation of the present invention on mice with chronic unpredictable stress (CUMS) depression model. (1) Experimental drugs: The extract of the traditional Chinese medicine composition in the comparative example above was mixed with dextrin and stirred for 15 minutes to obtain a soft material. The prepared soft material was placed into a vibrating granulator (with a 12-mesh nylon screen) for granulation to obtain uniformly sized granules. After drying the granules at a drying temperature of 60°C for 30 minutes, they were sieved through a vibrating screen with a top mesh of 10 mesh and a bottom mesh of 80 mesh, ensuring that the total amount of granules and powder that could not pass through the No. 1 sieve and could pass through the No. 5 sieve did not exceed 15%. After granulation, the corresponding traditional Chinese medicine granules were obtained for later use.

[0061] (2) Experimental method: Male Kunming mice were acclimatized for one week, and their weight was recorded. Before grouping, the mice were trained to adapt to sugar water. After 24 hours of water deprivation, a sugar water preference test was conducted. Unqualified mice that were too sensitive to or disliked sugar water were removed to ensure that the sugar preference rate of the mice was basically consistent, and mice that met the requirements were selected.

[0062] The model was established using an isolated rearing method, specifically by randomly administering 1-2 stimuli daily to replicate the chronic stress-induced depression model. These stimuli included fasting (12 hours), water deprivation (12 hours), reversed day-night cycle, swimming in cold water (4°C, 5 min), swimming in hot water (45 min, 5 min), tilted cage, damp bedding, restraint, tail clamping, foot shock (1 min), and shaking. A different stimulus was randomly administered each morning at 9:00 AM, with no predictability for the mice. The modeling period lasted 7 weeks. Before modeling, mouse body weight, sucrose preference, and open field behavioral tests were recorded. After modeling, mice showed weight loss, decreased sucrose preference, and reduced spontaneous activity and exploratory behavior, indicating successful modeling. Mice that successfully developed the model were randomly divided into 17 groups: model group, positive group, Examples 1-7 groups, and Comparative Examples 1-8 groups, with 10 mice in each group. Ten mice with the required glucose preference rate were also selected as the blank group. One week after modeling, each group was administered the drug by gavage while continuing the CUMS operation. The positive group was given fluoxetine hydrochloride 3.3 mg / kg. Examples 1-7 and Comparative Examples 1-8 were given the corresponding Chinese herbal medicine composition at a dose of 2.4 g of raw drug / kg. The blank group and the model group were administered an equal volume of physiological saline by gavage. Each group was given the drug once a day for 4 consecutive weeks.

[0063] (3) Detection indicators: 3.1 Behavioral indicators: ① Sugar water preference test Before modeling, mice were trained to adapt to 1% sucrose solution in a quiet environment. Mice were housed individually in cages, with two identical water bottles placed in each cage. During the first 24 hours, both bottles contained 1% sucrose solution; during the second 24 hours, one bottle contained 1% sucrose solution and the other contained pure water. Afterward, both bottles were removed and weighed. Before the experiment and at week 7, each mouse underwent a sucrose preference test. Before the experiment, the mice were fasted and deprived of water for 24 hours, then given two pre-quantified bottles of water: one containing 1% sucrose solution and the other pure water. After 24 hours, the bottles were removed and weighed, and the consumption of sucrose solution and pure water was recorded. The sucrose preference rate was calculated.

[0064] Sugar water preference rate = (sugar water consumption / total liquid consumption) × 100%.

[0065] ② Forced swimming experiment Mice were placed in a glass cylinder 24 cm high and 15 cm in diameter. Under water temperature of (25±1)℃, they were forced to swim for 6 minutes. The cumulative immobility time of the mice in the last 4 minutes was observed and recorded. The cumulative immobility time was defined as the time when the mice stopped struggling, floated in the water and remained still, or made only some necessary slight movements to keep their heads on the surface of the water.

[0066] ③ Tail suspension test The mouse's tail (about 1 cm from the tip) was fixed to a self-made tail suspension device (a cube made of opaque material, 40 cm long, wide and high, made by fixing small wooden clips with an iron frame), so that the mouse's head was about 10 cm from the bottom of the box. Three people simultaneously observed the mouse's activity over 6 minutes, recorded the cumulative immobility time of the mouse in the last 4 minutes, and calculated the average value.

[0067] ④ Open field experiment Each mouse was gently placed in the center of the open field test chamber, and its movement trajectory was recorded by the camera above it over 5 minutes. The horizontal movement score (total horizontal movement distance) and vertical score (number of standing) were analyzed. Before each mouse was tested, the bottom of the chamber was thoroughly cleaned with 75% ethanol to avoid odor interference with the experimental results of the next mouse.

[0068] 3.2 Measurement of biomarkers After behavioral testing, mice were euthanized by anesthesia with 50 mg / kg sodium pentobarbital. The brains were immediately isolated, and hippocampal tissue was collected, washed with physiological saline, and stored in liquid nitrogen for later use. The 5-weight ion concentration in the hippocampal tissue was detected according to the ELISA kit instructions. HT, DA and NE content.

[0069] Statistical analysis: The data were statistically analyzed, and the results are expressed as mean ± standard deviation. One-way ANOVA was used to compare differences between groups, and P < 0.05 was considered statistically significant.

[0070] (4) Experimental results: Table 1. Effects on depression-like behavior in a mouse model of depression.

[0071] Note: Compared with the blank group, # p < 0.05 ## p < 0.01; compared with the model group, & p < 0.05 && p < 0.01; compared with Example 1, % p < 0.05 %% p < 0.01.

[0072] As shown in the table above, compared with the blank group, the model group mice showed reduced carbohydrate digestion, shorter movement distance, longer immobility time during tail suspension and forced swimming, and all of these differences were highly significant (p < 0.01), indicating successful model establishment.

[0073] Compared with the model group, the depressive behavior of mice in Examples 1-7 was significantly improved (p<0.01), reaching a level comparable to that of the positive control drug; Comparative Examples 1-8 also showed varying degrees of effect in improving the depressive behavior of mice, with some indicators showing significant differences from the model group (p<0.05 or p<0.01), but far less than the examples of this application. For example, compared with Example 1, each comparative example showed significant differences in improving the depressive behavior of mice (p<0.05 or p<0.01).

[0074] Table 2. 5% of the hippocampal tissue of depressed model mice The influence of HT, DA, and NE levels

[0075] Note: Compared with the blank group, # p < 0.05 ## p < 0.01; compared with the model group, & p < 0.05 && p < 0.01; compared with Example 1, % p < 0.05 %% p < 0.01.

[0076] In emotion regulation, 5-HT is mainly responsible for addiction and compulsive behaviors, DA is mainly involved in reward and punishment regulation, and NE is mainly responsible for maintaining sleep and wakefulness. Changes in the levels and sensitivity of 5-HT and NE receptors can reduce neurotransmission function in patients, leading to depression. As shown in the table above, compared with the control group, the hippocampus of the model group mice had significantly higher levels of 5-HT and NE receptors. The significant reduction in HT, DA, and NE indicates that the mouse model of depression was successfully established.

[0077] Compared with the model group, the mouse hippocampus tissues of Examples 1-7 showed 5 The levels of HT, DA, and NE were significantly increased (p < 0.05 or p < 0.01); some indicators were also increased in Comparative Examples 1-6, but significantly lower than those in Example 1 of this application.

[0078] Furthermore, the traditional Chinese medicine compositions in Examples 4-7 exhibited depressive-like behavior and 5% hydroxychloroquine in the hippocampus of a mouse model of depression. The improvement effects on HT, DA, and NE levels were significantly worse than those in Example 1 (p < 0.05 or p < 0.01). It can be seen that the present invention further optimizes the proportions and dosages of each component of the traditional Chinese medicine composition, which can further enhance the antidepressant effect of the traditional Chinese medicine composition. Specifically, the preferred mass ratio of Cyperus rotundus, Citrus aurantium, and Citrus reticulata is 1:1-1.2:1-1.2; or the preferred mass ratio of Ligusticum chuanxiong and Paeonia lactiflora is 1:1.5-1.8.

[0079] II. Clinical Trials (1) Subjects: 100 outpatient medical records from the Sixth Hospital of Changchun City from 2021 to 2025. The gender and age distribution of the patients are shown in Table 3.

[0080] Table 3

[0081] (2) Treatment plan: 2.1 Diagnostic criteria: Symptoms: Pain in the hypochondrium, chest tightness, frequent sighing, depression, irritability or belching, and abdominal distension. The condition is often diagnosed based on two or more symptoms combined with auxiliary examinations. Symptoms may also change during the course of the disease. The onset is usually slow, and the course is relatively long.

[0082] 2.2 Examination methods: SAS Self-Rating Anxiety Scale (standard score cutoff value is 50 points), SDS Self-Rating Depression Scale (standard score cutoff value is 53 points), HAMA Hamilton Anxiety Scale (standard value is total score < 7 points), HAMD Hamilton Depression Rating Scale 24-item version (standard value is total score < 8 points). 2.3 Dialectical Classification: 1. Traditional Chinese Medicine Diagnosis: Liver Qi Stagnation 2.4 Treatment Plan: Bupleurum chinense 4g, Cyperus rotundus 4g, Citrus aurantium 4g, Citrus reticulata 4g, Ligusticum chuanxiong 4g, Paeonia lactiflora 7g, Glycyrrhiza uralensis 2g, Curcuma longa 7g, Inula japonica 4g. Total 40g, this is the daily dosage. Decoct in water and take twice daily. The entire course of treatment is 28 days.

[0083] 2.5 Evaluation of therapeutic effect: Significant effect: symptoms are reduced and abnormal indicators are significantly improved; Improvement: symptoms are reduced or improved and abnormal indicators are improved; (3) Ineffective: symptoms and abnormal indicators are not improved.

[0084] Effectiveness rate = (number of cases with significant effect + number of cases with improvement) / total number of cases × 100%.

[0085] 2.6 The statistical results of the clinical trials are shown in Table 4.

[0086] Table 4

[0087] The traditional Chinese medicine composition of the present invention has a total effective rate of 100% in the treatment of clinical depression, and the effect is significant.

[0088] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A traditional Chinese medicine composition for regulating qi and relieving depression, characterized in that, The traditional Chinese medicine composition comprises, in terms of weight fraction, Bupleurum 9-11 parts, Cyperus 9-11 parts, Fructus Aurantii 9-11 parts, Pericarpium Citri Reticulatae 9-11 parts, Ligusticum 9-11 parts, Radix Paeoniae Alba 15-20 parts, Glycyrrhiza 4-6 parts, Radix Curcumae 17-20 parts, and Inula 9-11 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises, in terms of weight fraction, Bupleurum 9-10 parts, Cyperus 10-11 parts, Fructus Aurantii 10-11 parts, Pericarpium Citri Reticulatae 10-11 parts, Ligusticum 10-11 parts, Radix Paeoniae Alba 17-18 parts, Glycyrrhiza 4.5-5.5 parts, Radix Curcumae 17-18 parts, and Inula 10-11 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition comprises, in terms of weight fraction, Bupleurum 10 parts, Cyperus 10 parts, Fructus Aurantii 10 parts, Pericarpium Citri Reticulatae 10 parts, Ligusticum 10 parts, Radix Paeoniae Alba 17.5 parts, Glycyrrhiza 5 parts, Radix Curcumae 17.5 parts, and Inula 10 parts.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The mass ratio of the Cyperus, Fructus Aurantii, and Pericarpium Citri Reticulatae is 1:1-1.2:1-1.2; and / or the mass ratio of the Ligusticum and Radix Paeoniae Alba is 1:1.5-1.

8.

5. The traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The traditional Chinese medicine composition is prepared by the following steps: taking Bupleurum, Cyperus, Fructus Aurantii, Pericarpium Citri Reticulatae, Ligusticum, Radix Paeoniae Alba, Glycyrrhiza, Radix Curcumae, and Inula, crushing and uniformly mixing them, and then obtaining the traditional Chinese medicine composition.

6. The traditional Chinese medicine composition according to any one of claims 1-4, characterized in that, The traditional Chinese medicine composition is prepared by the following steps: taking Bupleurum, Cyperus, Fructus Aurantii, Pericarpium Citri Reticulatae, Ligusticum, Radix Paeoniae Alba, Glycyrrhiza, Radix Curcumae, and Inula, crushing and adding them into water, decocting the mixture, filtering and concentrating the decocting liquid, and then obtaining the traditional Chinese medicine composition.

7. The traditional Chinese medicine composition according to claim 6, characterized in that, The decocting is performed for 2-3 times, each time adding 3-6 times the amount of water and extracting for 1-2 hours; preferably, the decocting is performed for 2 times, wherein the first time of decocting is performed by adding 6 times the amount of water and decocting for 1.5 hours, and the second time of decocting is performed by adding 4 times the amount of water and decocting for 1.5 hours.

8. A Chinese medicine preparation comprising the Chinese medicine composition according to any one of claims 1-7, characterized in that, The traditional Chinese medicine preparation is made of the traditional Chinese medicine composition; or made of the traditional Chinese medicine composition and a pharmaceutically acceptable carrier.

9. The traditional Chinese medicine preparation according to claim 9, characterized in that, The carrier comprises one or more of dextrin, starch, lactose, microcrystalline cellulose, and sugar powder.

10. The traditional Chinese medicine preparation according to claim 8 or 9, characterized in that, The traditional Chinese medicine preparation is prepared by the following steps: taking the traditional Chinese medicine composition and dextrin, mixing them to form a soft material, and then granulating, drying, and finishing the soft material to obtain the traditional Chinese medicine preparation.

11. Use of the traditional Chinese medicine composition of any one of claims 1-7 or the traditional Chinese medicine preparation of any one of claims 8-10 in the preparation of an anti-depression drug.

12. Use according to claim 11, characterized in that, The anti-depression drug is in any one of the following dosage forms: granules, tablets, capsules, pills, pastes, powders, decoctions, and oral solutions.

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