Traditional Chinese medicine composition for treating generalized anxiety as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention provides a traditional Chinese medicine composition for treating generalized anxiety as well as a preparation method and application thereof, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 8-17 parts of cortex albiziae, 15-30 parts of light wheat, 6-14 parts of radix paeoniae alba, 4-10 parts of radix bupleuri, 3-10 parts of radix curcumae, 4-10 parts of radix salviae miltiorrhizae, 3-9 parts of schisandra chinensis, 5-11 parts of jujube and 3-10 parts of liquorice. All the components have a synergistic effect, and the composition has an obvious improvement effect on mCPP-induced mouse anxiety-like behaviors, mCPP-induced rat anxiety-like behaviors, chronic constraint stress-induced mouse anxiety-like behaviors and PCPA-induced rat anxiety-like behaviors. The traditional Chinese medicine composition disclosed by the invention has an excellent effect of improving the generalized anxiety, and can be applied to preparation of medicines for improving the generalized anxiety.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating generalized anxiety and a preparation method and application thereof. BACKGROUND

[0002] Generalized anxiety disorder (GAD) is a common chronic mental disorder characterized by persistent and uncontrollable excessive worry, often accompanied by muscle tension, fatigue, sleep disorders and other somatic symptoms, which seriously affects the daily life and social function of patients.

[0003] At present, the etiology and pathogenesis of generalized anxiety disorder in modern medicine are not clear, but most studies believe that the main causes are: central nervous system neurotransmitter metabolism abnormalities and neural and endocrine network disorders after the interaction of genetic susceptibility and environmental stress.

[0004] The current treatment for generalized anxiety disorder (GAD) still mainly relies on drug therapy and cognitive behavioral therapy (CBT); the treatment drugs mainly include: selective serotonin reuptake inhibitors (SSRIs such as paroxetine), benzodiazepine drugs (such as diazepam tablets) and some antipsychotic drugs (such as quetiapine), but the above drugs still have the disadvantages of high risk of addiction (such as benzodiazepine drugs), obvious side effects, and the risk of increasing dementia (such as anticholinergic antidepressants) after long-term use. Short-term sedation for anxiety symptoms can only improve symptoms for a short time and cannot improve the etiology.

[0005] From the perspective of traditional Chinese medicine, the etiology of anxiety disorder is closely related to emotional disorders, visceral function disorders and yin-yang imbalance. Traditional Chinese medicine theory believes that the occurrence of anxiety disorder involves the functional disorders of multiple organs such as heart, liver, spleen and kidney. Emotional disorders can lead to liver stagnation, spleen dysfunction and poor qi movement, and further cause anxiety, insomnia and other symptoms. In the treatment of anxiety disorder, the basic treatment ideas of traditional Chinese medicine include nourishing blood, invigorating spleen and soothing liver and relieving depression, emphasizing the principles of soothing liver and relieving depression, nourishing heart and calming mind, invigorating spleen and reducing phlegm.

[0006] Traditional Chinese medicine decoction can support healthy qi and eliminate pathogenic factors, balance yin and yang, and consolidate the foundation, and has good potential in the drug treatment of generalized anxiety disorder. Chinese invention patent CN101744918A discloses a medicine for treating generalized anxiety disorder and a preparation method thereof. The traditional Chinese medicine raw materials in the medicine are: Radix Bupleuri 3-60 parts by weight, Radix Paeoniae Alba 4-45 parts by weight, Radix Salviae Miltiorrhizae 4-45 parts by weight, Radix Angelicae Sinensis 4-45 parts by weight, Suanzaoren 4-45 parts by weight, Citrus medica 2-15 parts by weight, and Rhizoma Coptidis 2-15 parts by weight. The medicine can reduce the content of 5-hydroxytryptamine (5-HT) in the brain tissue of liver stagnation model rats and improve the rate of gastrointestinal propulsion. It can also increase the number of rats crossing the light and dark box, increase the number of climbing steps and reduce the number of standing upright while climbing, reduce the number of autonomous activities of mice, and prolong the sleep time of mice, and has anxiolytic effect.

[0007] Chinese invention patent CN111053854A discloses a traditional Chinese medicine preparation with the effect of treating depression and its preparation method and application. The traditional Chinese medicine preparation is prepared from the following raw materials in parts by weight: Radix Bupleuri 10-30 parts, Fructus Aurantii 10-30 parts, Radix Paeoniae Alba 15-45 parts, Radix Paeoniae Alba 15-45 parts, Radix Puerariae 30-90 parts, Flos Albiziae 30-90 parts, Radix Glycyrrhizae 10-30 parts, Radix Aristolochiae 15-45 parts, Radix Glycyrrhizae 10-30 parts, Rhizoma Pinelliae 10-30 parts, Cortex Magnoliae Officinalis 10-30 parts, Poria 15-45 parts, dried leaf of Cicer arietinum 30-90 parts, Triticum aestivum 30-90 parts, Fructus Jujubae 10-30 parts, Radix Ephedrae 6-18 parts, and Fructus Schisandrae 6-18 parts. The traditional Chinese medicine preparation can significantly shorten the tail suspension immobility time of mice and the forced swimming immobility time of mice, and has reliable anti-depression effect.

[0008] However, in the field of traditional Chinese medicine technology, anti-anxiety and anti-depression belong to different diseases. The essence of depression is that emotions are "stagnant", and liver qi cannot be relaxed, resulting in inability to stretch qi and emotions, which is manifested as low, numbness, and weakness. The key to treatment is to "relieve" stagnation and then supplement and nourish the damaged. The essence of anxiety is that emotions are "disturbed", and liver qi is in disorder and fire disturbs the heart, resulting in loss of control of emotions and restlessness of the mind, which is manifested as tension, fear, and irritability. The key to treatment is to "calm" the disturbance and then nourish yin and reduce fire. Traditional Chinese medicine grasps the core pathogenesis through "differential diagnosis" and adjusts the prescription. Therefore, although the traditional Chinese medicine preparation can relieve emotions, it still cannot well resist anxiety.

[0009] In addition, although a large number of prior arts disclose Chinese medicinal compositions for treating anxiety disorders, the provided Chinese medicinal compositions mostly present independent effects or simple superposition of effects; or in the existing Chinese medicinal compositions with anti-anxiety effects, the types of components reach dozens, and the components in the compositions merely coexist without mutual synergistic effects, and even can have antagonistic adverse effects; in addition, some compositions have anti-anxiety effects, but generally only have good improvement effects on a certain anxiety behavior or a certain induced anxiety behavior, and cannot simultaneously have excellent improvement effects on multiple anxiety behaviors. Therefore, based on the complexity of Chinese medicinal formula, it is necessary to further study the Chinese medicinal formula in order to obtain a Chinese medicinal composition with mutual synergistic effects for resisting generalized anxiety. SUMMARY

[0010] The present application provides a Chinese medicinal composition for treating generalized anxiety and a preparation method and use thereof, and deeply studies Chinese medicinal ingredients, proportions and monarch-minister-attendant-chauffeur, in order to obtain a product with effects for treating generalized anxiety.

[0011] To achieve the above object, the technical scheme adopted by the present application is as follows: Firstly, the present application provides a Chinese medicinal composition for treating generalized anxiety, which is prepared from the following raw materials according to weight parts: Cortex Albiziae 8-17 parts, Triticum Repenense 15-30 parts, Radix Paeoniae Alba 6-14 parts, Radix Bupleuri 4-10 parts, Radix Curcumae 3-10 parts, Radix Salviae Miltiorrhizae 4-10 parts, Fructus Schisandrae 3-9 parts, Fructus Jujubae 5-11 parts and Radix Glycyrrhizae 3-10 parts.

[0012] Preferably, the Chinese medicinal composition is prepared from the following raw materials according to weight parts: Cortex Albiziae 10-15 parts, Triticum Repenense 20-25 parts, Radix Paeoniae Alba 7-12 parts, Radix Bupleuri 5-9 parts, Radix Curcumae 4-9 parts, Radix Salviae Miltiorrhizae 5-9 parts, Fructus Schisandrae 4-7 parts, Fructus Jujubae 6-10 parts and Radix Glycyrrhizae 4-9 parts.

[0013] Further preferably, the Chinese medicinal composition is prepared from the following raw materials according to weight parts: Cortex Albiziae 12 parts, Triticum Repenense 21 parts, Radix Paeoniae Alba 9 parts, Radix Bupleuri 6 parts, Radix Curcumae 6 parts, Radix Salviae Miltiorrhizae 6 parts, Fructus Schisandrae 6 parts, Fructus Jujubae 9 parts and Radix Glycyrrhizae 6 parts.

[0014] Then, the present application provides a preparation method of the above Chinese medicinal composition, which comprises the following steps: mixing Cortex Albiziae, Triticum Repenense, Radix Paeoniae Alba, Radix Bupleuri, Radix Curcumae, Radix Salviae Miltiorrhizae, Fructus Schisandrae, Fructus Jujubae and Radix Glycyrrhizae, soaking them in water, then decocting, filtering, concentrating and drying the filtrate to obtain the Chinese medicinal composition.

[0015] Preferably, the soaking time is 20-40 min; further preferably, the soaking time is 20-30 min.

[0016] Preferably, the soaking is achieved by immersing the medicinal materials in water; further preferably, the amount of water used is 6-12 times the mass of the raw materials; more preferably, the amount of water used is 10 times the mass of the raw materials.

[0017] In the present application, the amount of water used is 6-12 times the mass of the raw materials, and any point value or range value within the range of 6-12 can achieve the technical effects of the present application, and is not limited to 6 times, 6.5 times, 7 times, 7.5 times, 8 times, 8.5 times, 9 times, 9.5 times, 10 times, 10.5 times, 11 times, 11.5 times, or 12 times.

[0018] Preferably, the decocting is performed 2-4 times, and each time the decocting is performed for 1-2.5 hours; further preferably, the decocting is performed 2-3 times, and each time the decocting is performed for 1.5 hours.

[0019] In the present application, the decocting is performed for 1-2.5 hours, and any point value or range value within the range of 1-2.5 hours can achieve the technical effects of the present application, and is not limited to 1 hour, 1.2 hours, 1.4 hours, 1.5 hours, 1.6 hours, 1.8 hours, 2 hours, 2.2 hours, 2.4 hours, or 2.5 hours.

[0020] Preferably, the concentration is performed to a relative density of 1.02-1.4 (40-60°C) of the extract. In the present application, the concentration is performed to a relative density of 1.02-1.4 (40-60°C) of the extract, and any point value or range value within the range of 1.02-1.4 can achieve the technical effects of the present application, and is not limited to 1.02, 1.05, 1.1, 1.15, 1.2, 1.25, 1.3, 1.35, or 1.4.

[0021] Preferably, the drying is a drying method commonly used in the art, and is not limited to any one of reduced-pressure drying, spray drying, freeze drying, vacuum crystallization drying, or fluidized bed drying, and is performed until the moisture content is ≤8%.

[0022] Furthermore, the present application provides the use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine having a treatment effect on generalized anxiety.

[0023] Finally, the present application provides a medicine having a treatment effect on generalized anxiety, which comprises the component: the above-mentioned traditional Chinese medicine composition.

[0024] Preferably, the medicine further comprises the component: a pharmaceutically acceptable excipient.

[0025] The adjuvant ingredients can be either solid or in liquid form. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, acacia, magnesium stearate, stearic acid, dextrin, malt dextrin and soluble starch. Examples of liquid carriers include syrup, peanut oil, olive oil and water.

[0026] In preparing the compositions in oral dosage form, any convenient pharmaceutical media can be employed. For example, water, ethanol, oils, alcohols, flavoring agents, preservatives, coloring agents and the like can be used to form oral liquid preparations such as suspensions, solutions and emulsions; while carriers such as starches, sugars, microcrystalline cellulose, diluents, granulating agents, emulsifying agents, lubricants, binders, disintegrating agents can be used to form oral solid preparations such as powders, capsules and tablets with solutions being preferred over suspensions. Because of their ease of administration, tablets and capsules represent the most advantageous oral dosage unit form, and tablets in particular are preferred. Standard aqueous or nonaqueous techniques are employed for the formation of tablets.

[0027] Tablets containing the pharmaceutical compositions of the application or extracts can be prepared by compression or molding, optionally with one or more accessory ingredients or adjuvants. Tablets, and other solid dosage forms, can optionally be prepared with coatings or shells, i.e., protective sheaths or layers, and the like. Such coatings can be clear or opaque, colorless or colored, and can be flavored or unflavored. The tablets or pills of the application can be formulated to delay disintegration and dissolution in the gastrointestinal tract, and can contain various agents such as a sweetening agent, flavorant, colorant and a lubricant. Tablets or pills of the application can be formulated to release the active ingredient(s) either immediately, or after a delay of a few hours, or even after a delay of a few days. The tablets or pills of the application can be formulated to release the active ingredient(s) in a controlled manner, i.e., to release the active ingredient(s) at a predetermined rate or to release the active ingredient(s) over a predetermined period of time. Examples of controlled release preparations include osmotic, erodible, bioerodible, and swelling agents. Each tablet or capsule preferably contains about 0.05 mg to about 5 g of the active ingredient. For example, tablets or capsules containing about 0.5 mg to about 5 g of the active pharmaceutical ingredient mixed with a suitable amount of carrier materials can be prepared, which can constitute from about 5 to about 95 percent of the total composition. Unit dosage forms typically contain from about 1 mg to about 2 g of the active ingredient, often 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg or 1000 mg.

[0028] The pharmaceutical compositions of this application suitable for parenteral administration can be formulated as solutions or suspensions of the active compounds in either aqueous or nonaqueous vehicles, including oils. Suitable surfactants that can be used to facilitate the dispersion of the active compounds include hydroxypropylcellulose. Dispersions can also be prepared in glycerol, liquid polyethylene glycols, and mixtures thereof with oils. Additionally, preservatives can be added to prevent the growth of microorganisms.

[0029] The pharmaceutical compositions of this application can be in a form suitable for rectal administration. Such preparations include for example, suppositories, which are prepared by mixing the active compound with a suitable non-irritating excipient which is solid at room temperature but liquid at body temperature and therefore will melt in the rectum to release the active compound. Such materials include cocoa butter, beeswax and polyethylene glycols.

[0030] In addition to the above-mentioned carrier components, the above-mentioned pharmaceutical preparation can include, as appropriate, one or more additional carrier components, such as diluents, buffers, flavoring agents, binders, surface active agents, thickeners, lubricants, preservatives (including antioxidants), and the like. In addition, other excipients such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, and the like, coloring agents, and flavoring agents, and the like can be added. The components of the pharmaceutical composition of the present application can also be prepared in the form of a powder or a concentrated liquid.

[0031] Further preferably, the dosage form of the drug is not limited to a pill, a capsule, a granule, an oral liquid, a syrup, a powder, a tablet, a lozenge, a paste, a powder, a tea, a pill, a gel, a soft capsule, a micro-pill / micro-capsule, an effervescent agent, an oral suspension, an oral emulsion, a nano-suspension, a self-emulsifying preparation, a gel, an oral microsphere, a sustained-release or controlled-release tablet / capsule, an enteric-coated tablet / capsule, an oral osmotic pump tablet, an oral adhesive tablet, an oral film, and the like. Suitable pharmaceutical carriers in the art can be selected for different dosage forms.

[0032] In the present application, when the drug is a granule, the preparation method includes the steps of mixing the traditional Chinese medicine composition and the excipient, granulating, drying, sizing, and sieving to obtain the drug.

[0033] Preferably, the excipient is not limited to soluble starch, malt dextrin, aspartame, ethanol, mannitol, trehalose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch, pregelatinized starch, corn starch, resistant dextrin, beta cyclodextrin, gum arabic, magnesium stearate, or silicon dioxide.

[0034] Preferably, the granulation is wet swing granulation or dry granulation; the steps of wet granulation include mixing for 5-10 minutes using a wet granulator, then adding 95% ethanol and mixing for 1-3 minutes, and sieving through an 8-20 mesh sieve; the steps of dry granulation include using a roller compaction method and sieving through an 8-20 mesh sieve.

[0035] Further preferably, the steps of wet granulation include mixing for 8 minutes using a wet granulator, then adding 95% ethanol and mixing for 2 minutes, and sieving through a 16 mesh sieve; Further preferably, the steps of dry granulation include using a roller compaction method and sieving through a 10-12 mesh sieve.

[0036] Preferably, the drying method of the granule is any one of reduced pressure drying, spray drying, freeze drying, vacuum crystallization drying, or fluidized bed drying, and the drying is performed until the moisture content is ≤7%.

[0037] Preferably, in the sieving process of the granule, the upper layer is a 10-12 mesh sieve and the lower layer is a 40-80 mesh sieve, and the particles between the two layers of sieves are qualified granule products.

[0038] Compared with the prior art, the present application has the following beneficial effects: 1、The traditional Chinese medicine composition of the present application is composed of nine medicines, i.e. Cortex Albiziae, Triticum Repen, Radix Paeoniae Alba, Radix Bupleuri, Radix Curcumae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Fructus Jujubae and Radix Glycyrrhizae. In the prescription, Cortex Albiziae is sweet and flat in taste, and is good at relieving liver depression and soothing the mind, and is the monarch drug. Radix Paeoniae Alba nourishes blood and liver, and Radix Bupleuri soothes liver and gallbladder, and Radix Curcumae moves qi and resolves stasis, and is combined with Radix Bupleuri, and is the minister drug. Radix Salviae Miltiorrhizae is bitter and cold in nature, and is good at clearing blood and heart and relieving restlessness and soothing the mind. Fructus Schisandrae Chinensis benefits qi and generates fluid, and nourishes the kidney and calms the heart, and is the auxiliary drug. Triticum Repen nourishes heart yin, and removes heat and stops sweating. Fructus Jujubae and Radix Glycyrrhizae are sweet and flat in taste, and are used for relieving heart fire, and nourishing the heart and soothing the liver, and make the heart qi sufficient, and the yin fluid sufficient, and the liver qi harmonious, and are the auxiliary drugs. The combination of the above medicines can relieve liver and resolve depression, and activate blood and nourish the heart and soothe the mind, and is suitable for the treatment of generalized anxiety disorder.

[0039] 2、In the traditional Chinese medicine composition of the present application, Cortex Albiziae, Triticum Repen, Radix Paeoniae Alba, Radix Bupleuri, Radix Curcumae, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis, Fructus Jujubae and Radix Glycyrrhizae interact with each other, and complement each other, and bring the synergistic effect of increasing the number of entering the elevated plus maze and prolonging the staying time of the anxiety animals, increasing the activity time in the light box and the number of crossing the light and dark box of the anxiety animals, significantly increasing the 5-HT and NE (norepinephrine) contents in the hippocampus of the anxiety animals, significantly increasing the central distance percentage and the central time percentage of the anxiety animals, and increasing the 5-HT and MT (melatonin) contents in the hypothalamus of the anxiety animals, and have obvious improvement effects on the mCPP (m-chlorophenylpiperazine) induced anxiety-like behavior of mice, the mCPP induced anxiety-like behavior of rats, the chronic restraint stress induced anxiety-like behavior of mice, and the PCPA (p-chlorophenylalanine) induced anxiety-like behavior of rats. That is, the traditional Chinese medicine composition of the present application has significant improvement effects on the anxiety animals induced by various behaviors, which shows that the traditional Chinese medicine composition of the present application has excellent effects on improving generalized anxiety. The composition without the nine components of the present application, or with the components increased, decreased or replaced, or with the component ratio changed, has no significant improvement effect on the anxiety animals, and has no effect on improving generalized anxiety. Therefore, the composition of the nine components of the present application has excellent effects on improving generalized anxiety, and has improvement effects on various models, which is not predictable. BRIEF DESCRIPTION OF DRAWINGS

[0040] Figure 1 is the elevated plus maze experiment result graph of the traditional Chinese medicine composition on the mCPP induced anxiety-like behavior of mice.

[0041] Figure 2 is the light and dark box experiment result graph of the traditional Chinese medicine composition on the mCPP induced anxiety-like behavior of rats.

[0042] Figure 3is a result graph of the Chinese medicine composition on chronic restraint stress-induced anxiety-like behavior of mice in the elevated plus-maze experiment.

[0043] Figure 4 is a result graph of the Chinese medicine composition on chronic restraint stress-induced anxiety-like behavior of mice in the light-dark box experiment.

[0044] Figure 5 is a result graph of the Chinese medicine composition on chronic restraint stress-induced anxiety-like behavior of mice in the light-dark box experiment.

[0045] Figure 6 is a result graph of the Chinese medicine composition on chronic restraint stress-induced anxiety-like behavior of mice in the light-dark box experiment. DETAILED DESCRIPTION

[0046] The following non-limiting examples can make the ordinary skilled in the art more comprehensive understanding of the present application, but not in any way limit the present application. The following content is only an exemplary description of the scope of the present application, those skilled in the art can make various changes and modifications to the present application according to the disclosed content, and it should also belong to the scope of the present application claimed.

[0047] When the examples give a numerical range, it should be understood that, unless otherwise specified by the present application, each numerical range of two endpoints and any one of the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used in the present application have the same meaning as generally understood by those skilled in the art to which the present application belongs.

[0048] The present application is further described below in the manner of specific examples. The various chemical reagents used in the examples of the present application are obtained by conventional commercial routes unless otherwise specified. In the specific embodiments of the present application and effect verification, the raw materials and chemical reagents used, different products of different manufacturers do not have a significant effect on the effect.

[0049] Example 1 A Chinese medicine composition for treating generalized anxiety, made of the following raw materials according to weight parts: Jinyunpi 12 parts, floating wheat 21 parts, Baishao 9 parts, Chaihu 6 parts, Yujin 6 parts, Danshen 6 parts, Wuweizi 6 parts, Dazao 9 parts and Gancao 6 parts.

[0050] The preparation method of the Chinese medicine composition is: (1) the raw materials are weighed according to the weight ratio; (2) the raw materials are soaked in water until the water level is higher than the raw materials, and then soaked at room temperature for 30 minutes; add water until the water addition amount is 10 times the mass of the raw materials, and decoct twice, each time for 1.5 h, filter the decoction to obtain the filtrate; (3) combine the filtrate and concentrate to the relative density of 1.2 (40-60℃) of the extract; (4) The extract is dried under reduced pressure to obtain dry extract; (5) The dry extract is crushed to pass through a 100-mesh sieve to obtain the traditional Chinese medicine composition.

[0051] Example 2 A traditional Chinese medicine composition for treating generalized anxiety, which is prepared from the following raw materials according to weight parts: 10 parts of Chinese magnolia bark, 25 parts of common wheat, 7 parts of white peony root, 9 parts of bupleurum, 4 parts of curcuma, 9 parts of red sage root, 4 parts of schisandra, 6 parts of Chinese date and 9 parts of licorice.

[0052] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0053] Example 3 A traditional Chinese medicine composition for treating generalized anxiety, which is prepared from the following raw materials according to weight parts: 15 parts of Chinese magnolia bark, 20 parts of common wheat, 12 parts of white peony root, 5 parts of bupleurum, 9 parts of curcuma, 5 parts of red sage root, 7 parts of schisandra, 10 parts of Chinese date and 4 parts of licorice.

[0054] The preparation method of the traditional Chinese medicine composition is the same as that in Example 1.

[0055] Example 4 A traditional Chinese medicine composition for treating generalized anxiety, which is prepared from the following raw materials according to weight parts: 17 parts of Chinese magnolia bark, 15 parts of common wheat, 6 parts of white peony root, 4 parts of bupleurum, 10 parts of curcuma, 4 parts of red sage root, 9 parts of schisandra, 11 parts of Chinese date and 3 parts of licorice.

[0056] The preparation method of the traditional Chinese medicine composition is as follows: (1) The raw medicinal materials are weighed according to the weight ratio; (2) The raw medicinal materials are soaked in water for 20 minutes at room temperature, and then water is added to the raw materials until the water reaches 6 times the mass of the raw materials. The mixture is boiled for 2.5 hours twice, and the decoction is filtered to obtain the filtrate; (3) The filtrates are combined and concentrated to obtain an extract with a relative density of 1.02 (40-60°C); (4) The extract is dried under reduced pressure to obtain dry extract; (5) The dry extract is crushed to pass through a 60-mesh sieve to obtain the traditional Chinese medicine composition.

[0057] Example 5 A traditional Chinese medicine composition for treating generalized anxiety, which is prepared from the following raw materials according to weight parts: 8 parts of Chinese magnolia bark, 30 parts of common wheat, 14 parts of white peony root, 10 parts of bupleurum, 3 parts of curcuma, 10 parts of red sage root, 3 parts of schisandra, 5 parts of Chinese date and 10 parts of licorice.

[0058] The preparation method of the traditional Chinese medicine composition is as follows: (1) The raw medicinal materials are weighed according to the weight ratio; (2) The raw medicinal materials are soaked in water at room temperature for 40 minutes. Water is added until the amount of water is 12 times the mass of the raw materials. The mixture is decocted for 3 times, each time for 1 hour. The decoction is filtered to obtain a filtrate; (3) The filtrates are combined and concentrated to obtain an extract with a relative density of 1.4 (40-60°C); (4) The extract is dried under reduced pressure to obtain a dry extract; (5) The dry extract is crushed through a 300-mesh sieve to obtain the traditional Chinese medicine composition.

[0059] Comparative Example 1 The difference from Example 1 is that the Fufangqi is replaced by Hehunpi.

[0060] The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Hehunpi 33 parts, Baishao 9 parts, Chaihu 6 parts, Yujin 6 parts, Danshen 6 parts, Wuyizi 6 parts, Dazao 9 parts, and Gancao 6 parts.

[0061] The preparation method of the traditional Chinese medicine composition is as follows: (1) The raw medicinal materials are weighed according to the weight ratio; (2) The raw medicinal materials are soaked in water at room temperature for 30 minutes. Water is added until the amount of water is 10 times the mass of the raw materials. The mixture is decocted for 2 times, each time for 1.5 hours. The decoction is filtered to obtain a filtrate; (3) The filtrates are combined and concentrated to obtain an extract with a relative density of 1.2 (40-60°C); (4) The extract is dried under reduced pressure to obtain a dry extract; (5) The dry extract is crushed through a 100-mesh sieve to obtain the traditional Chinese medicine composition.

[0062] Comparative Example 2 The difference from Example 1 is that the Fufangqi is replaced by Hehunpi.

[0063] The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: Hehunpi 33 parts, Baishao 9 parts, Chaihu 6 parts, Yujin 6 parts, Danshen 6 parts, Wuyizi 6 parts, Dazao 9 parts, and Gancao 6 parts.

[0064] The preparation method of the traditional Chinese medicine composition is as follows: (1) The raw medicinal materials are weighed according to the weight ratio; (2) The raw medicinal materials are soaked in water at room temperature for 30 minutes. Water is added until the amount of water is 10 times the mass of the raw materials. The mixture is decocted for 2 times, each time for 1.5 hours. The decoction is filtered to obtain a filtrate; (3) The filtrates are combined and concentrated to obtain an extract with a relative density of 1.2 (40-60°C); (4) The extract is dried under reduced pressure to obtain a dry extract; (5) The dry extract is crushed through a 100-mesh sieve to obtain the traditional Chinese medicine composition.

[0065] Comparative Example 3 Different from Example 1, the Radix Paeoniae Alba and Radix Bupleuri are replaced by the same proportion of Radix Paeoniae Rubra and Radix Bupleuri.

[0066] The traditional Chinese medicine composition is prepared from the following raw materials according to weight parts: Cortex Albiziae 12 parts, Triticum Repenense 21 parts, Radix Paeoniae Alba 12.6 parts, Radix Bupleuri 8.4 parts, Radix Salviae Miltiorrhizae 6 parts, Fructus Schisandrae 6 parts, Fructus Jujubae 9 parts, and Radix Glycyrrhizae 6 parts.

[0067] The preparation method of the traditional Chinese medicine composition is as follows: (1) The raw medicinal materials are weighed according to the weight proportions; (2) The raw medicinal materials are soaked in water at room temperature for 30 minutes; water is added until the amount of water added is 10 times the mass of the raw materials, and decocted twice, each time for 1.5 hours; the decoction is filtered to obtain a filtrate; (3) The filtrates are combined and concentrated into an extract with a relative density of 1.2 (40-60°C); (4) The extract is dried under reduced pressure to obtain a dry extract; (5) The dry extract is crushed through a 100-mesh sieve to obtain the traditional Chinese medicine composition.

[0068] Comparative Example 4 Different from Example 1, the Radix Salviae Miltiorrhizae is replaced by Poria cocos.

[0069] The traditional Chinese medicine composition is prepared from the following raw materials according to weight parts: Cortex Albiziae 12 parts, Triticum Repenense 21 parts, Radix Paeoniae Alba 9 parts, Radix Bupleuri 6 parts, Radix Paeoniae Rubra 6 parts, Poria cocos 6 parts, Fructus Schisandrae 6 parts, Fructus Jujubae 9 parts, and Radix Glycyrrhizae 6 parts.

[0070] The preparation method of the traditional Chinese medicine composition is as follows: (1) The raw medicinal materials are weighed according to the weight proportions; (2) The raw medicinal materials are soaked in water at room temperature for 30 minutes; water is added until the amount of water added is 10 times the mass of the raw materials, and decocted twice, each time for 1.5 hours; the decoction is filtered to obtain a filtrate; (3) The filtrates are combined and concentrated into an extract with a relative density of 1.2 (40-60°C); (4) The extract is dried under reduced pressure to obtain a dry extract; (5) The dry extract is crushed through a 100-mesh sieve to obtain the traditional Chinese medicine composition.

[0071] Comparative Example 5 Different from Example 1, the ingredient Rhubarb is added.

[0072] The traditional Chinese medicine composition is prepared from the following raw materials according to weight parts: Cortex Albiziae 12 parts, Triticum Repenense 21 parts, Radix Paeoniae Alba 9 parts, Radix Bupleuri 6 parts, Radix Paeoniae Rubra 6 parts, Radix Salviae Miltiorrhizae 6 parts, Fructus Schisandrae 6 parts, Fructus Jujubae 9 parts, Radix Glycyrrhizae 6 parts, and Rhubarb 6 parts.

[0073] The preparation method of the traditional Chinese medicine composition is as follows: (1) each raw material is weighed according to the weight ratio; (2) the raw material is soaked in water at room temperature for 30 minutes; water is added to the raw material, and the amount of water added is 10 times the mass of the raw material; decoction is performed twice, each time for 1.5 hours; the decoction liquid is filtered to obtain a filtrate; (3) the filtrates are combined and concentrated into an extract with a relative density of 1.2 (40-60°C); (4) the extract is dried under reduced pressure to obtain a dry extract; (5) the dry extract is crushed to pass through a 100-mesh sieve to obtain the traditional Chinese medicine composition.

[0074] Comparative Example 6 The difference between Example 1 is that the weight ratio of each raw material component in the traditional Chinese medicine composition is different.

[0075] The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20 parts of Chinese magnolia bark, 20 parts of common wheat, 10 parts of white peony root, 6 parts of bupleurum, 4.5 parts of curcuma, 4 parts of salvia, 4.5 parts of schisandra, 6 parts of jujube, and 6 parts of licorice.

[0076] The preparation method of the traditional Chinese medicine composition is as follows: (1) each raw material is weighed according to the weight ratio; (2) the raw material is soaked in water at room temperature for 30 minutes; water is added to the raw material, and the amount of water added is 10 times the mass of the raw material; decoction is performed twice, each time for 1.5 hours; the decoction liquid is filtered to obtain a filtrate; (3) the filtrates are combined and concentrated into an extract with a relative density of 1.2 (40-60°C); (4) the extract is dried under reduced pressure to obtain a dry extract; (5) the dry extract is crushed to pass through a 100-mesh sieve to obtain the traditional Chinese medicine composition.

[0077] I. Effect of mCPP on inducing anxiety-like behavior in mice 1. Modeling and drug administration: After adaptive feeding, 110 male C57BL / 6 mice (SPF level, 35-48 days old, animal qualification certificate number: 20250507Abzz06190000535; experimental animal source: Zhejiang Weitong Lihua Experimental Animal Technology Co., Ltd.; experimental animal production license number: SCXK (Zhe) 2024-0001; experimental animal use license number: SYXK (Su) 2021-0065) were randomly divided into normal control group, model group, western medicine positive control group (diazepam tablets), traditional Chinese medicine positive control group (Jiwei Zhenxin Granules), Example 1 group, Example 2 group, Example 3 group, Example 4 group, Example 5 group, Comparative Example 1 group, and Comparative Example 2 group, 10 mice in each group. Except for the normal control group and the model group, each administration group was given the corresponding dose of 10.56 g / kg of the test substance once a day for 14 consecutive days. After the last administration, except for the normal control group, the rest of the groups of mice were intraperitoneally injected with mCPP at a dose of 4 mg / kg to induce anxiety-like behavior in mice, and 30 minutes later, the elevated plus maze experiment was performed to analyze the percentage (%) of open arm entry and the percentage (%) of open arm stay time of each group.

[0078] Percentage (%) of open arm entry = number of times entering the open arm part of the maze / total number of times entering the open arm and closed arm parts of the maze x 100%; Percentage (%) of open arm stay time = open arm stay time / total stay time in the elevated plus maze x 100%.

[0079] 2. The results are expressed as mean ± standard deviation, and the t-test is used for pairwise comparison of differences between groups, P<0.05, indicating statistical significance.

[0080] 3. The percentage (%) of open arm entry and the percentage (%) of open arm stay time of each group of mice are shown in Table 1, and the results of the elevated plus maze experiment of the traditional Chinese medicine composition on mCPP-induced anxiety-like behavior in mice are shown in Figure 1 .

[0081] Table 1

[0082] Note: 1# Calculated based on the content of diazepam; 2# Calculated based on the active substance of the decoction piece.

[0083] In Table 1, compared with the normal control group, # P<0.05, ## P<0.01; compared with the model group, △ P<0.05, △△ P<0.01; compared with the Example 1 group, & P<0.05, &&P<0.01.

[0084] Compared with the normal control group, the percentage of open arm entry and the percentage of open arm stay time of the model group were significantly reduced, and the difference was statistically significant (P<0.05, P<0.01), indicating that the anxiety degree of the model group mice was significantly increased, and the modeling was successful. Compared with the model group, the percentage of open arm entry and the percentage of open arm stay time of the western medicine positive control group, the traditional Chinese medicine positive control group and the example group increased, indicating that the anxiety degree of the mice was reduced. Specifically, the percentage of open arm entry and the percentage of open arm stay time of the example group of the application were significantly increased, and the technical effect was better than that of the traditional Chinese medicine positive control group and the comparative example group, showing a significant effect of improving anxiety. The percentage of open arm entry and the percentage of open arm stay time brought by the composition of the comparative example group were worse than those of the example group. It is indicated that although the comparative example with changed prescription has a certain anti-anxiety effect, the improvement effect on mCPP-induced anxiety-like behavior of mice is low, and it cannot achieve effective therapeutic effect.

[0085] II. Influence on mCPP-induced anxiety-like behavior of rats 1. Modeling and administration: After adaptive feeding, 90 male SD rats (SPF level, body weight 170-190 g; animal qualification certificate number: A202504070284; experimental animal source: Sibeifu (Suzhou) Biotechnology Co., Ltd.; experimental animal production license number: SCXK (Su) 2022-0006; experimental animal use license number: SYXK (Su) 2022-0043) were randomly divided into normal control group, model group, example 1 group, example 2 group, example 3 group, example 4 group, example 5 group, comparative example 3 group and comparative example 4 group according to body weight, 10 rats in each group. Except for the normal control group and the model group, the other administration groups were given the corresponding dose of 7.3 g / kg of the test substance once a day for 14 consecutive days. After the last administration, except for the normal control group, the rest of the groups were injected with mCPP at a dose of 1 mg / kg intraperitoneally to induce anxiety-like behavior in rats, and 30 minutes later, the light-dark box experiment was performed. According to the software, the percentage of left box (light box) activity time (%) and the number of shuttles between light and dark boxes of each group were statistically analyzed.

[0086] The percentage of left box (light box) activity time (%) = left box (light box) activity time / total activity time x 100%.

[0087] The light-dark box experiment is also a classical behavioral experiment commonly used to evaluate anxiety-like behavior in rodents, and its principle is based on the conflict between the natural aversion of rodents to bright environments (dark-seeking) and their curiosity to explore new environments. Animals with high anxiety levels tend to stay in the dark box and reduce activity in the light box and the number of shuttles between the light and dark boxes.

[0088] 2、Results were expressed as mean ± standard deviation, and the differences between groups were compared by t-test, P<0.05, indicating statistical significance.

[0089] 3、The percentage of time spent in the left box (open box) and the number of times of crossing between the light and dark boxes of rats in each group were shown in Table 2, and the results of open field test of mCPP-induced anxiety-like behavior of rats were shown in Figure 2 .

[0090] Table 2

[0091] In Table 2, compared with the normal control group, ## P<0.01; compared with the model group, △ P<0.05; compared with the control group and the group of Example 1, & P<0.05.

[0092] Compared with the normal control group, the percentage of time spent in the left box (open box) and the number of times of crossing between the light and dark boxes of the model group were significantly reduced (P<0.01), indicating that the modeling was successful. Compared with the model group, after administration of the traditional Chinese medicine composition of the examples, the percentage of time spent in the left box (open box) and the number of times of crossing between the light and dark boxes of each group were significantly increased (P<0.05), and different group proportions within the protection scope of the application showed the efficacy of improving anxiety symptoms. Compared with the control group and the control group of Example 4, the traditional Chinese medicine composition of the examples of the application significantly increased the percentage of time spent in the left box (open box) and the number of times of crossing between the light and dark boxes, which indicated that the components in the traditional Chinese medicine composition of the examples of the application were not randomly replaced or conventionally selected, and the traditional Chinese medicine composition without the components and proportions of the application could not achieve the technical effects of the application, and the improvement of mCPP-induced anxiety-like behavior of rats was poor.

[0093] III. Effect on anxiety-like behavior of mice induced by chronic restraint stress (CRS) 1. Modeling and administration: After acclimation, 100 ICR mice aged 35-48 days (SPF level; animal qualification certificate number: 20241025Abzz0619000102 (female), 20241025Abzz0619000617 (male); source of experimental animals: Zhejiang Vintone Lihua Experimental Animal Technology Co., Ltd.; experimental animal production license number: SCXK (Zhe) 2024-0001; experimental animal use license number: SYXK (Su) 2021-0065) were taken, half male and half female. Except for the normal control group (n=20), the rest were modeling groups to replicate the CRS anxiety model. The specific operation: the mice were placed in a 50 mL centrifuge tube with a diameter of 3 mm small hole on the tube wall and placed horizontally for restraint, 3 hours a day (about 12:00-15:00), for 7 consecutive days. Subsequently, 10 mice were randomly taken from the normal control group and the modeling group to judge whether the model was successful by behavioral detection. On the 8th day, 70 mice in the modeling group were randomly divided into the model group, Example 1 group, Example 2 group, Example 3 group, Example 4 group, Example 5 group, and Comparative Example 5 group, 10 mice in each group. In the morning every day, except for the normal control group and the model group given double distilled water, each administration group was given 10.56 g / kg of the test substance. About 1 hour after administration, except for the normal control group, the rest of the mice in each group continued to be restrained for 3 hours, once a day, for 14 consecutive days.

[0094] 2. Elevated plus maze test: The elevated plus maze test was performed before the end of the experiment. The percentage of open arm entries and the percentage of open arm residence time of each group were statistically analyzed according to the software.

[0095] Percentage of open arm entries (%) = number of times entering the open arm part of the maze / total number of times entering the open arm and closed arm parts of the maze x 100%; Percentage of open arm residence time (%) = open arm residence time / total residence time in the elevated plus maze x 100%.

[0096] 3. Light-dark box test: The light-dark box test was performed before the end of the experiment. The percentage of left box (light box) activity time and the number of shuttles between light and dark boxes of each group were statistically analyzed according to the software.

[0097] The elevated plus maze test and the light-dark box test were performed before the end of the experiment. After the behavioral detection, the mice were sacrificed, and the hippocampal tissue was taken to detect the contents of 5-HT (5-hydroxytryptamine) and NE (norepinephrine).

[0098] 4. Determination of hippocampal neurotransmitter content: After behavioral detection, the mice were sacrificed, and the hippocampal tissue was taken to detect the contents of 5-HT and NE.

[0099] 5、Results were expressed as mean ± standard deviation, and the differences between groups were compared by t-test, P<0.05, indicating statistical significance.

[0100] 6、The percentage of open arm entries and the percentage of open arm time of each group of mice are shown in Table 3; the results of the elevated plus maze experiment of the chronic restraint stress-induced mouse anxiety-like behavior are shown in Figure 3 .

[0101] The percentage of left box (light box) activity time and the number of shuttle times between light and dark boxes of each group of mice are shown in Table 4; the results of the light-dark box experiment of the chronic restraint stress-induced mouse anxiety-like behavior are shown in Figure 4 .

[0102] The results of the hippocampal tissue 5-HT and NE content of each group of mice are shown in Table 5.

[0103] Table 3

[0104] In Table 3, compared with the normal control group, # P<0.05; compared with the model group, △ P<0.05; compared with the model group, & P<0.05.

[0105] As can be seen from Table 3, compared with the normal control group, the percentage of open arm entries and the percentage of open arm time of the model group were significantly reduced (P<0.05), indicating that the CRS model group of mice had obvious anxiety-like behavior, and the modeling was successful. Compared with the model group, the percentage of open arm entries was significantly increased after administration of the traditional Chinese medicine composition of the application (P<0.05), suggesting that the anxiety-like behavior of the mice was improved. Compared with the model group, the percentage of open arm entries and the percentage of open arm time of the comparative example 5 group also showed a trend of increase, but the improvement effect was very low, and the efficacy was not as good as that of the example group; the effects of the comparative example 5 group and the example group were compared, and the difference was statistically significant, suggesting that the prescription of the traditional Chinese medicine composition in the example of the application was reasonable and had significant efficacy.

[0106] Table 4

[0107] In Table 4, compared with the normal control group, # P<0.05, ## P<0.01; compared with the model group, △ P<0.05, △△ P<0.01; compared with the model group, & P<0.05.

[0108] As shown in Table 4, compared with the normal control group, the percentage of activity time in the left box (open box) and the number of shuttles between the open and dark boxes in the model group were significantly reduced (P < 0.05, P < 0.01), indicating that the CRS model group exhibited significant anxiety-like behavior and the modeling was successful. Compared with the model group, administration of the traditional Chinese medicine composition of the example significantly increased the percentage of activity time in the left box (open box) and the number of shuttles (P < 0.05, P < 0.01), suggesting that the anxiety-like behavior of mice was significantly improved. The effects of the comparative group 5 were significantly weaker than those of the example group, and the difference in technical effects was statistically significant, indicating that the formulation of the traditional Chinese medicine composition in the example of this invention is reasonable and has significant therapeutic effects. The addition of components to the comparative group 5 disrupted the synergistic effect of the components in the original traditional Chinese medicine composition, resulting in a significant decrease in the anti-anxiety effect on mice under chronic restraint stress.

[0109] Table 5

[0110] Table 5 shows the comparison with the normal control group. # P < 0.05; compared with the model group, △△ P < 0.01; compared with Example 1 group, the comparative example group, & P < 0.05.

[0111] Imbalance of the neurotransmitter system is one of the important mechanisms in the development of anxiety disorders. The 5-HT and NE neurotransmitter systems are closely related to the development of anxiety disorders.

[0112] As shown in Table 5, compared with the normal control group, the levels of 5-HT and NE in the hippocampus of mice in the model group were significantly reduced (P < 0.05), indicating an imbalance in the levels of neurotransmitters related to anxiety in the hippocampus in the CRS model group. Compared with the model group, administration of the traditional Chinese medicine composition of the present invention significantly increased the levels of 5-HT and NE (P < 0.01), suggesting that the imbalanced neurotransmitter levels in the hippocampus may be restored to some extent. The improvement effect of Comparative Example 5 was not as good as that of Example 5 group, and the difference was statistically significant.

[0113] In summary, the traditional Chinese medicine composition of the present invention with specific formulation and ratio has a significant effect on improving anxiety-like behavior induced by CRS in mice. It can increase the percentage of activity time and number of shuttles in the left box (light box) of mice in the light-dark box experiment, as well as the percentage of central distance and central time in the open field experiment. Its mechanism of improving anxiety may be related to restoring the imbalanced neurotransmitter system in the hippocampus of anxious mice.

[0114] IV. Effects of p-chlorophenylalanine (PCPA) on anxiety-like behavior in rats 1. Modeling and administration: After acclimation, 70 male SD rats (SPF level, body weight 150-170 g; animal qualification certificate number: A202502280046; experimental animal source: Sibeifu (Suzhou) Biotechnology Co., Ltd.; experimental animal production license number: SCXK (Su) 2022-0006; experimental animal use license number: SYXK (Su) 2022-0043) were randomly divided into a normal control group (n=10) and a modeling group (n=60) according to body weight. The modeling group was injected intraperitoneally with p-chlorophenylalanine (PCPA) weak alkaline suspension at 350 mg / kg for 2 consecutive days to induce a sleep disorder-induced anxiety rat model. The normal control group was injected intraperitoneally with the same volume of weak alkaline normal saline. Subsequently, the modeling group was randomly divided into a model group, Example 1 group, Example 2 group, Example 3 group, Example 4 group, and Comparative Example 6 group according to body weight, with 10 rats in each group. Except for the normal control group and the model group, which were given double distilled water, each administration group was given the corresponding dose of 7.3 g / kg of the test substance once a day for 7 consecutive days.

[0115] 2. Light-dark box test: The light-dark box test was performed before the end of the test. The percentage of left box (light box) activity time and the number of shuttles between the light-dark boxes of each group were statistically analyzed according to the software.

[0116] Percentage of left box (light box) activity time (%) = left box (light box) activity time / total activity time x 100%.

[0117] 3. Open field test: The open field test was performed before the end of the test. The percentage of central distance (%) and the percentage of central time (%) of each group were statistically analyzed according to the software.

[0118] Percentage of central distance (%) = central region movement distance / total movement distance x 100%; Percentage of central time (%) = central region movement time / total movement time x 100%.

[0119] 4. Determination of neurotransmitter content: After the above behavioral tests, the rats were sacrificed, and the hypothalamus was removed to determine the contents of 5-HT (5-hydroxytryptamine) and MT (melatonin).

[0120] 5. The results are expressed as mean ± standard deviation, and the differences between groups were compared using t-test. P<0.05 indicates statistical significance.

[0121] 6. The results of the percentage of left box (light box) activity time and the number of shuttles between the light-dark boxes of each group of rats are shown in Table 6. The results of the light-dark box test of the p-chlorophenylalanine (PCPA)-induced anxiety-like behavior in rats are shown in Figure 5 .

[0122] The results of the percentage of central distance and the percentage of central time of each group of rats in the open field test are shown in Table 7, and the results of the open field test of rats induced by p-chlorophenylalanine (PCPA) are shown in Figure 6 .

[0123] The results of the hypothalamic 5-HT and MT content of each group of rats are shown in Table 8.

[0124] Table 6

[0125] In Table 6, compared with the normal control group, ## P<0.01, compared with the model group, △△ P<0.01, compared with the example 1 group, & P<0.05, && P<0.01.

[0126] As can be seen from Table 6, compared with the normal control group, the percentage of activity time in the left box (light box) and the number of shuttles between the light and dark boxes of the model group were significantly reduced (P<0.01), indicating that sleep circadian rhythm disorder induced obvious anxiety-like behavior. Compared with the model group, after being given the traditional Chinese medicine composition of the application, each example group could increase the percentage of activity time in the left box (light box) and the number of shuttles between the light and dark boxes, and the example group suggested that the anxiety-like behavior of the rats was obviously improved. The comparative example 6 group also showed a trend of increasing the activity time in the left box (light box) and the number of shuttles between the light and dark boxes, and the improvement effect was significantly weaker than that of the traditional Chinese medicine composition of the application in the example, and the difference in technical effect had statistical significance.

[0127] Table 7

[0128] In Table 7, compared with the normal control group, # P<0.05, compared with the model group, △ P<0.05, compared with the example 1 group, & P<0.05.

[0129] As can be seen from Table 7, compared with the normal control group, the percentage of central distance and the percentage of central time of the model group were significantly reduced (P<0.05), indicating that sleep circadian rhythm disorder induced obvious anxiety-like behavior in rats. Compared with the model group, after being given the traditional Chinese medicine composition of the application, the percentage of central distance and the percentage of central time were increased (P<0.05), suggesting that the anxiety-like behavior of the rats was obviously improved. Although the comparative example 6 group also showed a trend of increasing the activity time in the left box (light box) and the number of shuttles between the light and dark boxes, the improvement effect was weaker than that of the traditional Chinese medicine composition of the application in the example, and the technical effect of the comparative example had statistical significance.

[0130] Table 8

[0131] In Table 8, compared with the normal control group, # P < 0.05; compared with the model group, △△ P < 0.01; compared with Example 1 group, the comparative example group, & P < 0.05.

[0132] As shown in Table 8, compared with the normal control group, the hypothalamic MT content in the model group was significantly reduced (P < 0.05), but the 5-HT content showed no difference. This suggests that after one week of administration, the inhibitory effect of PCPA was relieved, and the 5-HT content recovered somewhat, but the MT content remained reduced, indicating the presence of sleep disorders. Compared with the model group, administration of the traditional Chinese medicine composition of the present invention significantly increased the hypothalamic 5-HT content (P < 0.05) and significantly increased the MT content (P < 0.01). Although the comparative group 6 also showed a trend of increasing hypothalamic 5-HT and MT content, the improvement effect was significantly weaker than that of the example group, which was statistically significant.

[0133] In summary, the traditional Chinese medicine composition of the present invention has a significant effect on improving PCPA-induced anxiety-like behavior in rats. It can also significantly increase the activity time and number of shuttles in the light box in the light-dark box experiment, and increase the proportion of central distance and central time in the open field experiment. Its anti-anxiety mechanism involves the regulation of 5-HT and MT levels in the hypothalamus.

[0134] Conclusion: In the above four animal models of anxiety, the traditional Chinese medicine composition of the present invention was verified to have significant anti-anxiety effects under specific component and ratio conditions, and it had a significant improvement effect on generalized anxiety in all four models. The effect was better than that of the control model, and the data difference was statistically significant. The formulation of the present invention has good application prospects in the preparation of drugs for treating and improving generalized anxiety.

[0135] 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 treating generalized anxiety disorder, characterized in that, The product is made from the following ingredients by weight: 8-17 parts of Albizia bark, 15-30 parts of wheat bran, 6-14 parts of white peony root, 4-10 parts of Bupleurum root, 3-10 parts of Curcuma root, 4-10 parts of Salvia miltiorrhiza root, 3-9 parts of Schisandra fruit, 5-11 parts of jujube, and 3-10 parts of licorice root.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The product is made from the following ingredients by weight: 10-15 parts of Albizia bark, 20-25 parts of wheat bran, 7-12 parts of white peony root, 5-9 parts of Bupleurum root, 4-9 parts of Curcuma root, 5-9 parts of Salvia miltiorrhiza root, 4-7 parts of Schisandra fruit, 6-10 parts of jujube, and 4-9 parts of licorice root.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The product is made from the following ingredients by weight: 12 parts Albizia bark, 21 parts floating wheat, 9 parts white peony root, 6 parts Bupleurum root, 6 parts Curcuma root, 6 parts Salvia miltiorrhiza root, 6 parts Schisandra fruit, 9 parts jujube, and 6 parts licorice root.

4. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The steps include: mixing Albizia bark, wheat bran, white peony root, bupleurum root, turmeric, salvia root, schisandra fruit, jujube, and licorice root, soaking them in water, decocting them, filtering, concentrating the filtrate, and drying it to obtain the traditional Chinese medicine composition.

5. The preparation method according to claim 4, characterized in that, The soaking time is 20-40 minutes; the amount of water used is 6-12 times the mass of the raw material.

6. The preparation method according to claim 4, characterized in that, The decoction is performed 2-4 times, with each decoction lasting 1-2.5 hours.

7. The preparation method according to claim 6, characterized in that, The decoction is performed 2-3 times, with each decoction lasting 1.5 hours.

8. The preparation method according to claim 4, characterized in that, The concentrate is concentrated into an extract with a relative density of 1.02-1.

4.

9. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating generalized anxiety disorder.

10. A drug for treating generalized anxiety disorder, characterized in that, The composition includes the traditional Chinese medicine composition according to any one of claims 1-3.

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