Application of traditional Chinese medicine composition in preparation of medicine for preventing and / or treating anxiety disorder

Abstract

The invention relates to the technical field of traditional Chinese medicines, relates to new application of a traditional Chinese medicine composition, and in particular relates to application of the traditional Chinese medicine composition in preparation of a medicine for preventing and / or treating anxiety disorder. The traditional Chinese medicine composition is prepared from cassia twig, white peony root, honey-fried licorice root, ginger, jujube, ginseng, Chinese angelica, salted morinda officinalis and dwarf lilyturf tuber. The traditional Chinese medicine composition provided by the invention can obviously inhibit the anxiety state of an anxiety rat, reduce the contents of TNF-alpha, IL-1beta, IL-6, NE and 5-HT in serum of the anxiety rat, and increase the BDNF level; moreover, the content of IL-6, IL-1beta and TNF-alpha in hypothalamic tissues of anxiety rats can be reduced, and the compound has a relatively good treatment effect on anxiety.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and more particularly to a new use of a traditional Chinese medicine composition in preparing a medicine for preventing and / or treating anxiety. Background Art

[0002] Anxiety disorders, also known as anxiety neuroses, are the most common of the broader neurotic disorders and can be categorized into chronic anxiety, generalized anxiety, and acute anxiety. People with anxiety disorders may experience excessive fear or worry about specific situations (for example, panic attacks or social situations) or, in the case of generalized anxiety disorder, about a wide range of everyday situations. They typically experience these symptoms over a long period of time—at least several months. Other symptoms of anxiety disorders may include: nervous worry with no clear objective object, restlessness, autonomic nervous system dysfunction symptoms such as palpitations, hand tremors, sweating, frequent urination, and motor restlessness.

[0003] The etiology of anxiety disorders remains unclear, but may be related to genetic factors, personality traits, cognitive processes, adverse life events, biochemistry, and physical illness. Currently, modern medical treatments for anxiety disorders primarily involve pharmacotherapy with drugs such as norepinephrine and serotonin reuptake inhibitors (NSRs), benzodiazepines, and selective serotonin reuptake inhibitors (SSRIs), as well as psychotherapy such as cognitive behavioral therapy, Morita therapy, and relaxation therapy. While Western medications can alleviate symptoms to some extent, their side effects and withdrawal symptoms can affect treatment compliance. Furthermore, the numerous physical symptoms associated with anxiety disorders lead to many patients being misdiagnosed or overtreated. Approximately one-fifth of the highest healthcare users suffer from anxiety disorders, which increases the financial burden on patients and wastes medical resources. However, Traditional Chinese Medicine (TCM) offers advantages in understanding this condition, including unique theoretical insights, significant efficacy, and minimal side effects.

[0004] Therefore, providing a Chinese medicine composition for preventing and / or treating anxiety disorders has important practical significance. Summary of the Invention

[0005] In view of this, the present invention provides a Chinese medicine composition for preventing and / or treating anxiety disorders.

[0006] In order to achieve the above-mentioned object of the invention, the present invention provides the following technical solutions:

[0007] The present invention provides use of a traditional Chinese medicine composition in preparing a medicine for preventing and / or treating anxiety disorders. The main active ingredients of the traditional Chinese medicine composition include, by weight, 10-25 parts of cassia twig, 10-25 parts of white peony root, 5-25 parts of liquorice root, 10-30 parts of ginger, 15-30 parts of jujube, 10-30 parts of ginseng, 10-30 parts of angelica root, 10-30 parts of Morinda officinalis, and 10-30 parts of ophiopogon japonicus.

[0008] This prescription utilizes Morinda officinalis (Baotian), a herb from the Foot Shaoyin Meridian, and Panax ginseng (Guangshi), a herb from the Hand Shaoyin Meridian, as the main herbs. Morinda officinalis (Baotian), a herb from the Foot Shaoyin Meridian, is sweet and warm, replenishing fire without scorching water. This combined nourishment of fire and water stimulates the primordial yang from the depths of the cauldron, strengthening essence and protecting spirit. Panax ginseng is sweet, slightly bitter, and slightly warm in nature. It enters the Hand Shaoyin Meridian, nourishing the five internal organs, calming the mind, settling the soul, calming palpitations, opening the heart and improving intelligence. It significantly replenishes vital energy, nourishes qi and blood, and nourishes the heart and calms the mind. These two herbs enter the heart and kidneys, one above and one below, one south and one north, respectively, connecting the heart and kidneys. Angelica sinensis and cinnamon twigs complement the main herbs, nourishing liver blood, invigorating liver wood, and soothing liver qi. Simultaneously, Ophiopogon japonicus and White Peony Root astringe and descend lung metal. Ophiopogon japonicus enters the lung meridian, astringing and descending lung metal and calming nighttime sleepiness, while the sourness of White Peony Root astringes heart qi and calms nighttime sleepiness. These two herbs, one left and one right, one east and one west, elevate the liver and descend the lungs. Ginger, licorice, and jujube are added to pivot the Qi in the middle burner, ensuring harmonious ascending and descending movements and a smooth, orderly rotation of the four dimensions. This formula replenishes body fluids, circulates the spleen and stomach's fluids, and harmonizes the Ying and Wei systems. In this formula, ginseng and Morinda officinalis work together to "strengthen the organs from which skill emerges," enhancing daytime energy. Angelica sinensis and white peony root, being extremely gentle, act as "the root of exhaustion," calming and calming nighttime sleep. The entire formula has the effects of warming the middle and replenishing deficiency, elevating the liver and lungs, connecting the heart and kidneys, harmonizing Qi and blood, and guiding Yang into Yin.

[0009] The sources of raw materials for this recipe are as follows:

[0010] Cinnamon twigs: Dried young twigs of Cinnamomum cassia (Cinnamomum cassia). Serves the Heart, Lung, and Bladder meridians. Pungent, sweet, and warm.

[0011] White peony root: The dried root of Paeonia lactiflora Pall. (Ranunculaceae). It enters the Liver and Spleen meridians. It has a bitter, sour, and slightly cold nature.

[0012] Licorice: The dried root of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat., or Glycyrrhiza glabra L. (all from the Leguminosae family). It enters the Heart, Lung, Spleen, and Stomach meridians. It is sweet and neutral. Roasted licorice root is a processed licorice root. Preparation: Take clean licorice slices, add refined honey and a small amount of boiling water, mix well, and briefly simmer. Stir-fry until yellow or dark yellow. Remove from heat when no longer sticky and let cool.

[0013] Ginger: Fresh rhizome of Zingiber officinale Rosc. (Zingiber officinale Rosc.). It enters the lung, spleen, and stomach meridians. It has a pungent, slightly warming effect.

[0014] Jujube: The dried mature fruit of Ziziphus jujuba Mill. var. inermis (Bunge) Reh d., a plant of the Rhamnaceae family. It enters the spleen and stomach meridians. It has a sweet and warm nature.

[0015] Ginseng: The dried root of Panax ginseng (Camey) in the Araliaceae family. Cultivated ginseng is called "garden ginseng," while sun-dried or oven-dried ginseng is called "raw sun-dried ginseng." It enters the spleen, lung, and heart meridians. It has a sweet, slightly bitter, neutral flavor.

[0016] Angelica sinensis: The dried root of Angelica sinensis (Oliv.) Diels, a plant in the Umbelliferae family. It enters the liver, heart, and spleen meridians. It has a sweet, pungent, and warming effect.

[0017] Morinda officinalis: The dried root of Morinda officinalis (Rubiaceae). It enters the kidney and liver meridians. It has a sweet, pungent, and slightly warming nature.

[0018] Ophiopogon japonicus: The dried root of Ophiopogon japonicus (Thunb.) Ker-Gaw wl., a plant of the Liliaceae family. It enters the Heart, Lung, and Stomach meridians. It has a sweet, slightly bitter, and slightly cold flavor.

[0019] In some specific embodiments of the present invention, the main active ingredients include, by mass: 15 parts of cinnamon twig, 15 parts of white peony root, 12 parts of liquorice, 18 parts of ginger, 18 parts of jujube, 10 parts of ginseng, 15 parts of angelica, 10 parts of Morinda officinalis, and 10 parts of Ophiopogon japonicus.

[0020] In some specific embodiments of the present invention, the licorice root is prepared licorice root, and the Morinda officinalis is salt Morinda officinalis. Prepared licorice root has a sweeter taste and a warmer nature, and has stronger effects of invigorating the spleen and replenishing qi, and warming the middle and tonifying deficiency. Salt Morinda officinalis is warm but not dry, has relatively less toxicity, and has a stronger medicinal effect.

[0021] In some specific embodiments of the present invention, the drug further comprises a medically acceptable excipient. Specifically, the excipient used is a carrier or excipient commonly used in the art, including but not limited to starch, lactose, glucose, sodium carboxymethyl cellulose, ethyl cellulose, methyl cellulose, malt, gelatin, polyols (such as propylene glycol, glycerol, mannitol), compressed tablets, etc., to help improve the stability or activity of the drug, or to produce an acceptable taste or smell when taken orally.

[0022] In some specific embodiments of the present invention, the dosage form of the drug is decoction, tablet, capsule, granule, oral solution or pill, so as to facilitate clinical administration.

[0023] In some specific embodiments of the present invention, the preparation method of the traditional Chinese medicine composition comprises: mixing the raw medicinal materials according to a ratio, decocting them twice with water, decocting them for 1.5 hours with 10 times the amount of water for the first time and decocting them for 1 hour with 8 times the amount of water for the second time, combining the decoctions, filtering, and concentrating the filtrate to an extract with a relative density of 1.10 to 1.20 (60°C).

[0024] In some specific embodiments of the present invention, the preparation method of the drug comprises: mixing the raw medicinal materials according to a ratio, decocting twice with water, decocting for 1.5 hours with 10 times the amount of water for the first time, and decocting for 1 hour with 8 times the amount of water for the second time, combining the decoctions, filtering, concentrating the filtrate to an extract with a relative density of 1.10 to 1.20 (60° C.), and mixing with excipients to obtain the extract;

[0025] Alternatively, the raw medicinal materials are mixed according to the ratio, 8 to 10 times the weight of water are added, and the water extraction is performed twice. The water extracts are combined and concentrated to 1 gram of crude drug / mL.

[0026] In some specific embodiments of the present invention, when the dosage form of the drug is a decoction, the preparation method thereof comprises the following steps:

[0027] Mix the raw medicinal materials according to the proportion, add 8 to 10 times the weight of water and boil for 30 to 40 minutes to obtain the product.

[0028] In some specific embodiments of the present invention, when the dosage form of the drug is tablets, capsules, granules, oral liquid or pills, the preparation method thereof comprises the following steps:

[0029] The raw medicinal materials are mixed according to the proportion, 8 to 10 times the weight of water are added, and the water extraction is performed twice. The water extracts are combined and concentrated to 1 gram of crude drug / mL, and auxiliary materials are added. The corresponding dosage form is prepared according to the conventional method in the field.

[0030] In some embodiments of the present invention, the prevention and / or treatment of anxiety disorders comprises:

[0031] (I) Increase the total distance of open-arm exercise, the time of open-arm exercise, and the total distance of exercise;

[0032] (II), reducing the levels of IL-6, IL-1β and / or TNF-α in serum and / or hypothalamic tissue;

[0033] (III), reducing the levels of NE and / or 5-HT in serum; and / or

[0034] (IV) Increase the level of BDNF in serum.

[0035] The present invention provides the use of a traditional Chinese medicine composition in the preparation of a medicament for preventing and / or treating anxiety disorders. The traditional Chinese medicine composition provided by the present invention can significantly inhibit the anxiety state of anxiety rats, reduce the levels of TNF-α, IL-1β, IL-6, NE and 5-HT in the serum of anxious rats, and increase the level of BDNF; and can also reduce the levels of IL-6, IL-1β and TNF-α in the hypothalamic tissue of anxious rats, indicating that the traditional Chinese medicine composition has a significant improvement effect on anxiety disorders. DETAILED DESCRIPTION

[0036] The present invention discloses the use of a Chinese medicine composition in the preparation of a medicament for preventing and / or treating anxiety disorders. Those skilled in the art can refer to the contents of this article and appropriately improve the process parameters to achieve the above. It should be noted that all similar substitutions and modifications are obvious to those skilled in the art and are considered to be included in the present invention. The methods and applications of the present invention have been described through preferred embodiments, and relevant personnel can obviously modify or appropriately change and combine the methods and applications described herein without departing from the content, spirit and scope of the present invention to implement and apply the technology of the present invention.

[0037] Unless otherwise specified, the following experiments were conducted under conventional conditions or those recommended by the manufacturer. All APIs, excipients, reagents, and instruments used, unless the manufacturer is specified, are commercially available. Unless otherwise specified, all percentages, ratios, proportions, and parts are by weight.

[0038] Unless otherwise defined, all professional and scientific terms used herein have the same meaning as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein can be applied to the present invention.

[0039] The present invention will be further described below in conjunction with the embodiments:

[0040] Example 1 Preparation of the Chinese medicine composition granules of the present invention

[0041] Take 250g of white peony root, 250g of roasted licorice root, 300g of ginger, 300g of jujube, 167g of ginseng, 250g of angelica, 167g of Morinda officinalis, and 167g of Ophiopogon japonicus, add water and boil twice, add 10 times the amount of water for the first time and boil for 1.5 hours, add 8 times the amount of water for the second time and boil for 1 hour, combine the decoctions, filter, and concentrate the filtrate to an extract with a relative density of 1.10-1.20 (60°C) to obtain a traditional Chinese medicine composition, add maltodextrin, dry, grind into fine powder, add maltodextrin, mix well, make into granules, dry, and make into 1000g.

[0042] Experimental Example 2 Effect of a Chinese herbal composition on improving anxiety behavior in rats with chronic restraint-induced anxiety disorder 1. Experimental materials

[0043] 1.1 Animals

[0044] Sixty SPF-grade 8-week-old male SD rats, weighing (160-180) g, were purchased from Hangzhou Medical College (production), production license number: SCXK (Zhejiang) 2019-0002.

[0045] 1.2 Medication

[0046] The Chinese medicine composition prepared in Example 1 was purchased from Jiangsu Kangyuan Pharmaceutical Co., Ltd.

[0047] 1.3 Instruments

[0048] Refrigerator (Haier Company, model: BCD-216SZ); electronic balance (Sartorius Scientific Instrument Company, model: BSA224S-CW); purified water instrument (Millipore Company, Germany, model: Milli-QPlus); animal weighing scale (Shanghai Xiangchuan Electronic Scale Co., Ltd., model: ACX-SC-DA); XR-XG201 elevated plus maze (EPM), XR-Xmaze animal behavior analysis system (Shanghai Xinruan Information Technology Co., Ltd.).

[0049] 2. Dosage design

[0050] The unit dosage of the traditional Chinese medicine composition is 2051g of crude drug, plus excipients, to obtain a finished product of 1000g. Six bags are taken daily (twice daily, three bags at a time), equivalent to a daily dose of 123g of crude drug per person. Based on the body surface area conversion method, the equivalent dose for rats is 123g / 60kg*6.2=12.71g / kg, which is the median dose. Using a 0.5:1:2 dosing ratio, the low dose is 6.36g / kg and the high dose is 25.42g / kg.

[0051] 3. Experimental Methods

[0052] Rats were acclimated for 3 days with free access to feed and water. They were randomly divided into a blank control group and a modeling group. The modeling group rats were placed in a 200 mm long, 50 mm inner diameter PVC water pipe, restricted in their range of motion, and deprived of food and water. After each day of restraint, they were allowed to resume normal diet and free movement. The modeling period lasted 14 days, with restraint increasing by 1 hour from day 1 to day 8, and remaining at 8 hours per day from day 9 to day 14. The successfully established rats were divided into five groups: a model control group, a positive drug diazepam group (0.001 g / kg), and a group receiving low, medium, and high doses of a traditional Chinese medicine composition (6.36 g / kg, 12.71 g / kg, and 25.42 g / kg), each with 10 rats. The blank and model groups were given equal amounts of pure water, while the remaining groups were gavaged with the corresponding drug solution for 7 consecutive days.

[0053] Detection indicators: An elevated cross maze test was performed 14 days after model establishment to test anxiety-like behavior.

[0054] 4. Statistical methods

[0055] The results were compared between groups using one-way ANOVA.

[0056] 5. Experimental Results

[0057] Results showed that after 14 days of chronic restraint stress modeling, the blank group showed no significant changes. However, the total distance traveled, time spent in the open arms, and number of entries into the open arms were significantly reduced compared to the blank group (P < 0.0001), indicating successful modeling. Seven days after administration, the total distance traveled, time spent in the open arms, and total distance traveled by rats in the low-, medium-, and high-dose groups of the Chinese medicine composition were significantly increased compared to the model group. The results are shown in Table 1.

[0058] Table 1 Effects of Chinese herbal medicine combination on the elevated plus maze test results of rats in each group after modeling ( n=10)

[0059]

[0060]

[0061] Note: Compared with the normal group, #### P<0.0001; compared with the model group, *P<0.05, **P<0.01, ****P<0.0001.

[0062] 6. Experimental Conclusion

[0063] The elevated plus maze test can evaluate the anxiolytic effect of drugs. After administration of low, medium and high doses of the Chinese medicine composition, the total distance of open arm movement, open arm movement time and total movement distance of rats were significantly increased compared with the model group.

[0064] Experimental Example 3 Effects of Chinese herbal composition on inflammatory factors and neural factors in rats with chronic restraint-induced anxiety

[0065] 1. Experimental Materials

[0066] 1.1 Animals

[0067] Sixty SPF-grade 8-week-old male SD rats, weighing (160-180) g, were purchased from Hangzhou Medical College (production), production license number: SCXK (Zhejiang) 2019-0002.

[0068] 1.2 Medication

[0069] The Chinese medicine composition was prepared according to the method of Example 1 and provided by Jiangsu Kangyuan Pharmaceutical Co., Ltd.

[0070] 1.3 Instruments

[0071] Refrigerator (Haier Company, model: BCD-216SZ); electronic balance (Sartorius Scientific Instruments Company, model: BSA224S-CW); multifunctional microplate reader (MD Company, USA, model: Flexstation 3); animal weighing scale (Shanghai Xiangchuan Electronic Scale Co., Ltd., model: ACX-SC-DA); NE and 5-HT test kits (Wuhan Boster Bioengineering Co., Ltd.); BDNF test kit (R&D Company, USA).

[0072] 2. Dosage design

[0073] The daily dosage of the Chinese herbal medicine composition is 2051g of the crude drug, plus excipients, to obtain a finished product of 1000g. Six bags are taken daily (twice daily, three bags at a time), equivalent to a daily dose of 123g of the crude drug per person. Based on the body surface area conversion method, the equivalent dose for rats is 123g / 60kg*6.2=12.71g / kg, which is the median dose. Using a 0.5:1:2 dosing ratio, the low dose is 6.36g / kg and the high dose is 25.42g / kg.

[0074] 3. Experimental Methods

[0075] Example 1 After the behavioral test, the rats were decapitated and blood was collected. The blood was centrifuged at 12000 r / min for 5 min, and the supernatant was stored in a -80°C refrigerator for further testing. Appropriate amounts of hypothalamic tissue were taken, and the hypothalamic tissue was homogenized with PBS (pH 7.4). The homogenate was centrifuged at 4°C and 3000 r / min for 20 min, with a radius of 7.4 cm, and the supernatant was taken. Within 2 h, enzyme-linked immunosorbent assay (ELISA) was used to determine the levels of serum IL-6, IL-1β, TNF-α, NE, 5-HT, BDNF, and IL-6, IL-1β, and TNF-α in the hypothalamus. The operation was carried out in strict accordance with the instructions of the ELISA kit.

[0076] Detection indicators:

[0077] 1) Determination of inflammatory-related factors, neural factors, and neurotransmitters in serum;

[0078] 2) Determination of inflammation-related factors in hypothalamic tissue.

[0079] 4. Statistical methods

[0080] The results were compared between groups using one-way ANOVA.

[0081] 5. Experimental Results

[0082] Results showed that compared with the normal group, the serum levels of IL-6, IL-1β, and TNF-α in the model group rats were significantly increased (P < 0.0001), indicating successful modeling. Compared with the model group, the levels of these inflammatory factors in the lung serum of mice in the positive drug group and the low-, medium-, and high-dose groups of the Chinese herbal composition were significantly reduced, with the high-dose group showing the most significant improvement. It is currently believed that the occurrence of anxiety disorders is related to the effects of neurokines and neurotransmitters. The serum levels of NE and 5-HT in the model group rats were higher than those in the blank group, while the level of BDNF was lower than that in the blank group, with statistically significant differences (P < 0.0001). After administration of the low-, medium-, and high-dose Chinese herbal composition, the serum levels of NE and 5-HT decreased, while the level of BDNF increased. This indicates that the Chinese herbal composition has a good regulatory effect on rats with anxiety. The results are shown in Tables 2 and 3.

[0083] Compared with the normal group, the levels of IL-6, IL-1β, and TNF-α in the hypothalamic tissue of the model rats were significantly increased. Inflammation-related factors were significantly decreased after administration of the Chinese herbal composition at low, medium, and high doses. These results indicate that the Chinese herbal composition has a good therapeutic effect on inflammation in rats with chronic restraint stress-induced anxiety disorder. The results are shown in Table 4.

[0084] Table 2 Comparison of TNF-α, IL-1β, and IL-6 levels in rat serum ( n=6)

[0085]

[0086]

[0087] Note: Compared with the normal group, #### P<0.0001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001,

[0088] ****P<0.0001.

[0089] Table 3 Comparison of NE, 5-HT and BDNF levels in rat serum ( n=10)

[0090]

[0091] Note: Compared with the normal group, #### P<0.0001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001,

[0092] ****P<0.0001.

[0093] Table 4 Comparison of TNF-α, IL-1β, and IL-6 levels in rat hypothalamus tissue ( n=10)

[0094]

[0095]

[0096] Note: Compared with the normal group, #### P<0.0001; compared with the model group, *P<0.05, **P<0.01, ***P<0.001, ****P<0.0001.

[0097] 6. Experimental Conclusion

[0098] After administration of low, medium and high doses of the Chinese medicine composition, the levels of IL-6, IL-1β and TNF-α in the serum and hypothalamus tissue of anxiety rats were significantly decreased; and the levels of NE and 5-HT in serum were reduced, while the level of BDNF was increased, indicating that the Chinese medicine composition has a good regulatory effect on anxiety rats.

[0099] The above embodiments of the present invention are merely examples for the purpose of clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. Those skilled in the art will appreciate that other variations or modifications may be made based on the above description. It is not necessary and impossible to enumerate all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the claims of the present invention.

Claims

1. Use of a Chinese medicine composition in the preparation of a medicament for preventing and / or treating anxiety, characterized in that: In parts by weight, the Chinese medicine composition comprises:

2. The use according to claim 1, characterized in that In parts by weight, the Chinese medicine composition comprises:

3. The use according to claim 1 or 2, characterized in that The licorice is roasted licorice, and the Morinda officinalis is salt Morinda officinalis.

4. The use according to any one of claims 1 to 3, characterized in that The medicine comprises the traditional Chinese medicine composition and pharmaceutically acceptable excipients.

5. The use according to any one of claims 1 to 4, characterized in that The dosage form of the medicine is one or more of granules, decoction, tablets, capsules, oral liquid or pills.

6. The use according to any one of claims 1 to 5, characterized in that The preparation method of the traditional Chinese medicine composition comprises: mixing various raw medicinal materials according to a proportion, decocting with water twice, decocting with 10 times the amount of water for the first time for 1.5 hours, and decocting with 8 times the amount of water for the second time for 1 hour, combining the decoctions, filtering, and concentrating the filtrate to an extract with a relative density of 1.10 to 1.20 (60° C.).

7. The use according to any one of claims 1 to 6, characterized in that The preparation method of the medicine comprises: mixing the raw medicinal materials according to a proportion, decocting with water twice, decocting with 10 times the amount of water for 1.5 hours for the first time and decocting with 8 times the amount of water for 1 hour for the second time, combining the decoctions, filtering, concentrating the filtrate to an extract with a relative density of 1.10 to 1.20 (60° C.), and mixing with auxiliary materials to obtain the extract; Alternatively, the raw medicinal materials are mixed according to the ratio, 8 to 10 times the weight of water are added, and the water extraction is performed twice. The water extracts are combined and concentrated to 1 gram of crude drug / mL.

8. The use according to claim 7, characterized in that When the dosage form of the drug is a granule, the preparation method comprises: mixing the raw medicinal materials according to a proportion, decocting twice with water, decocting for 1.5 hours with 10 times the amount of water for the first time, and decocting for 1 hour with 8 times the amount of water for the second time, combining the decoctions, filtering, concentrating the filtrate to an extract with a relative density of 1.10 to 1.20 (60° C.), adding maltodextrin, drying, crushing into fine powder, adding maltodextrin, mixing, forming granules, and drying to obtain the product; When the dosage form of the drug is a decoction, tablet, capsule, oral solution or pill, the preparation method comprises: mixing the raw medicinal materials according to a proportion, adding 8 to 10 times the weight of water, extracting twice with water, combining the water extracts, concentrating to 1 gram of crude drug / mL, adding excipients, and preparing the corresponding dosage form.

9. The use according to any one of claims 1 to 8, characterized in that The prevention and / or treatment of anxiety disorders includes: (I) Increase the total distance of open-arm exercise, the time of open-arm exercise, and the total distance of exercise; (II), reducing the levels of IL-6, IL-1β and / or TNF-α in serum and / or hypothalamic tissue; (III), reducing the levels of NE and / or 5-HT in serum; and / or (IV) Increase the level of BDNF in serum.

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