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

Abstract

The invention relates to the technical field of traditional Chinese medicines, relates to a new application of a traditional Chinese medicine composition, and in particular relates to an application of the traditional Chinese medicine composition in preparing a medicine for preventing and / or treating depression. 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 increase the body weight and social interaction index of a social contusion depression model mouse and reduce the corticosterone content in serum; and the total movement distance and the central region retention time of an open field experiment in a chronic mild stress rat depression model are obviously increased, the content of 5-HT in plasma is increased, and a good treatment effect on depression is achieved.

Description

Technical Field

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

[0002] Depression is a feeling of sadness and / or decreased interest or pleasure in activities that becomes a disorder when it is intense enough to interfere with functioning. Although depression may develop after a recent loss or other traumatic event, the sadness often manifests as an inappropriate emotional response that is out of proportion to the situation and lasts for a long time. Depression is characterized by a marked and persistent low mood, accompanied by a loss of interest and pleasure, which often affects an individual's work, school, and social functioning.

[0003] Depression can be caused by a variety of factors, including genetic, biological, psychosocial, and environmental factors. Clinically, symptoms require a persistent episode of depression lasting for at least two weeks. Some patients experience self-harm and suicidal behavior, accompanied by psychotic symptoms such as delusions and hallucinations. In severe cases, depressive stupor may develop, characterized by fixed facial expressions, lack of response to stimuli, minimal or no speech, and minimal or no movement. According to the World Health Organization, depression affects approximately 280 million people worldwide.

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

[0005] In view of this, the present invention provides use of a traditional Chinese medicine composition in the preparation of a medicament for preventing and / or treating depression.

[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 depression. 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 depression includes improving abnormalities in neurobiochemical indicators.

[0031] In some specific embodiments of the present invention, the improvement of abnormal neurobiochemical indicators includes:

[0032] (I) Improve the social ability of mice with social frustration depression model;

[0033] (II), reducing the level of corticosterone in serum;

[0034] (III) increasing the total distance traveled and the time spent in the center area in an open field behavioral test; and / or

[0035] (IV) Increase the 5-HT content in plasma.

[0036] The present invention provides the use of a traditional Chinese medicine composition in the preparation of a medicament for treating depression. The traditional Chinese medicine composition provided by the present invention can significantly improve the social ability of mice in a social frustration depression model and reduce the corticosterone content in the serum; increase the total movement distance and the time spent in the center area in an open field behavioral experiment, that is, increase the exploratory desire in a chronic mild stress rat depression model, and increase the 5-HT content in the plasma, indicating that the traditional Chinese medicine composition can exert an antidepressant effect by improving the abnormalities of neurochemical indicators in the body. DETAILED DESCRIPTION

[0037] The present invention discloses the use of a Chinese medicine composition in the preparation of a medicament for preventing and / or treating depression. Those skilled in the art can refer to the contents of this invention and appropriately improve the process parameters to achieve the desired effect. 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.

[0038] 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.

[0039] 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.

[0040] The present invention will be further described below in conjunction with the embodiments:

[0041] Example 1 Preparation of the Chinese medicine composition granules of the present invention

[0042] Take 250g of cinnamon twig, 250g of white peony root, 200g 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 and boil for 1.5 hours for the first time, and add 8 times the amount of water and boil for 1 hour for the second time, 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, make granules, dry, and make 1000g.

[0043] Experimental Example 2 Therapeutic Effect of Chinese Medicine Composition on Social Frustration Depression Model Mice

[0044] 1. Experimental Materials

[0045] 1.1 Animals

[0046] 120 male CD-1 mice, 4 to 6 months old, were housed in single cages for 7 days; 72 male C57BL / 6J mice, 6 to 8 weeks old, weighing 18 to 20 g were used in the experiment.

[0047] 120 male retired ICR (CD-1) mice, 4 to 6 months old, were individually caged for 7 days of acclimatization. CD-1 mice were screened for aggression over 3 consecutive days and were excluded if they exhibited at least two sustained attacks, with a latency to the first attack of less than 60 seconds. CD-1 mice with a 50% pass rate were selected and challenged with different C57BL / 6J mice daily during the 10-day social defeat model.

[0048] Twelve male C57BL / 6J mice, 6-8 weeks old, weighing 18-20g, were used for screening. The screening C57BL / 6J mice were placed directly into the housing of individually housed CD-1 mice for 3 minutes, ensuring that the C57BL / 6J mice could not escape the CD-1 housing area. The screening C57BL / 6J mice were used only to screen qualified CD-1 mice and were not used in subsequent experiments.

[0049] The experiment involved 60 male C57BL / 6J mice, 6-8 weeks old, weighing 18-20g. Ten C57BL / 6J mice served as a blank control group, and 50 C57BL / 6J mice were subjected to a 10-day social defeat model. Following the modeling, the C57BL / 6J mice were randomly divided into a model group, a fluoxetine-treated group, and high-, medium-, and low-dose groups of the Chinese medicine composition, with 10 mice per group.

[0050] Breeding environment: room temperature 20-26℃, relative humidity controlled at 40-70%.

[0051] 1.2 Medication

[0052] The traditional Chinese medicine composition prepared in Example 1 was purchased from Jiangsu Kangyuan Pharmaceutical Co., Ltd.; fluoxetine hydrochloride capsules were purchased from Suzhou Sinochem Pharmaceutical Co., Ltd., 20 mg / capsule.

[0053] Mouse Corticosterone (CORT) Elisa Kit (Nanjing Jiancheng Bioengineering Institute, catalog number: H205); physiological saline was purchased from Shaanxi Shengao Animal Pharmaceutical Co., Ltd.

[0054] 1.3 Instruments

[0055] Electronic analytical balance, METTLER TOLEDO, model: ME303E; high-speed refrigerated centrifuge, Eppendorf, model: BY-20; multifunctional enzyme plate reader, PerkinElmer P, model: Enspire; small animal behavior instrument, Reward, model: SMART3.0.

[0056] 2. Dosage design

[0057] The unit prescription for Shuhe is 2051g of crude drug. After water extraction, concentration, and drying, approximately 738g of dry paste powder is obtained. Excipients are added and granulated to obtain 1000g of the finished product. Each bag contains 10g, containing 20.5g of crude drug. Taking 6 bags per day (twice a day, 3 bags at a time) is equivalent to taking 123g of crude drug per person per day. According to the body surface area conversion method, the equivalent dose for mice is 123g / 60kg*12.3=25.22g crude drug / kg. This dose is set as the medium dose group, then the low dose group receives 12.61g crude drug / kg, and the high dose group receives 50.44g crude drug. Administration is by gavage at 0.2mL / 10g once a day.

[0058] The daily dosage of fluoxetine hydrochloride capsules is 40 mg / day. According to the body surface area conversion method, the equivalent dose for mice is 40 mg / 60 kg*12.3=8.2 mg / kg.

[0059] 3. Experimental Methods

[0060] 3.1 Selection of CD-1 mice as challenge mice

[0061] To ensure CD-1 mice are not aggressive, a double number of CD-1 mice was prepared to screen for highly aggressive CD-1 mice. Non-breeding male CD-1 mice, 4-6 months of age, were housed individually in cages for 7 days to acclimate and develop territorial awareness. Six- to seven-week-old C57BL / 6J mice, 5 per cage, were also housed for 7 days to acclimate. Screening experiments were conducted in the CD-1 mouse housing cages. Screening C57BL / 6J mice were placed directly into the individually housed CD-1 mouse housing cages for 3 minutes, ensuring that the C57BL / 6J mice could not escape the CD-1 mouse housing area. Regardless of the latency to attack, the C57BL / 6J mice were removed after the 3-minute delay. Screening was performed daily for three consecutive days to ensure that each CD-1 mouse attacked a different C57BL / 6J mouse. During the three screening rounds, the CD-1 mice must exhibit at least two sustained aggressive behaviors, with the latency to the first attack being less than 60 seconds. CD-1 mice that did not meet these criteria were removed.

[0062] 3.2 Social frustration stimulation

[0063] Every day after the experiment began, experimental C57BL / 6J mice were placed in the cages of selected CD1 mice as "aggressor" mice and subjected to a 5-minute fight. During the fight, the C57BL / 6J mice displayed avoidance, fear, and submissive behaviors due to the attack from the CD1 mice. After the fight, the two mice were separated by a porous transparent organic plastic sheet. For the next 24 hours, the defeated mice were allowed to passively accept non-contact stimuli such as scent and sound from the CD1 mice. This stress lasted for 10 days. A control group was housed in the same cages, separated by a porous transparent organic plastic sheet.

[0064] 3.4 Administration

[0065] Drug administration began 24 hours after modeling. Each drug-treated group was given 0.2 mL / 10 g of drug by gavage once a day for 14 consecutive days. The normal control group and the model control group were given normal saline under the same conditions.

[0066] Testing Indicators: ① Social Interaction Ratio: 24 hours after the last administration, measure the social interaction time of each mouse. SI ratio = Social Interaction Time B (CD-1 mice present) / Social Interaction Time A (CD1 mice absent). ② 1.5 mL of blood was collected from the eyeball, centrifuged to separate the plasma, and the supernatant serum was aspirated. Serum CORT concentration was measured using an enzyme-linked immunosorbent assay (ELISA) kit.

[0067] 4. Statistical methods

[0068] The results were statistically analyzed using One-Way ANOVA test.

[0069] 5. Experimental Results

[0070] 5.1 Effects on body weight and social interaction index in social frustration model mice

[0071] Mice were stimulated with social interaction frustration for 10 days. Twenty-four hours after modeling, mice were treated with the Chinese herbal composition for 14 days. Compared with the normal control group, the body weight and social interaction index of the mice decreased significantly, with statistically significant differences (P<0.05, P<0.0001). Compared with the model control group, the body weight and social interaction index of the high- and medium-dose groups increased significantly, with statistically significant differences (P<0.01, P<0.001, P<0.0001). See Table 1.

[0072] Table 1: Effects on body weight and social interaction index in social frustration depression model mice

[0073]

[0074] Note: Compared with the normal control group, # P<0.05,## P<0.01; compared with the model control group, ** P<0.01, *** P<0.001, **** P<0.0001.

[0075] 5.2 Effects on serum corticosterone (CORT) in social defeat model mice

[0076] ELISA results showed that compared with the normal control group, the serum CORT level of mice in the model control group was significantly increased, with a statistically significant difference (P<0.0001). Compared with the model control group, the serum CORT levels of the high- and medium-dose groups were significantly decreased, with a statistically significant difference (P<0.0001). See Table 2.

[0077] Table 2: Effects on CORT levels in mice model of social frustration depression

[0078]

[0079] Note: Compared with the normal control group, #### P<0.0001; compared with the model control group, **** P<0.0001.

[0080] 6. Experimental Conclusion

[0081] The Chinese herbal composition at 50.44 and 25.22 g / kg can significantly increase the body weight and social interaction index of mice with social frustration depression model and reduce the CORT content in serum, indicating that the Chinese herbal composition has a certain therapeutic effect on social frustration-induced depression mice.

[0082] Experimental Example 3 Therapeutic Effects of a Chinese Medicine Composition on Chronic Mild Stress Depression Model Rats 1. Experimental Materials

[0083] 1.1 Animals

[0084] 60 male SD rats, SPF grade, weighing 160-180 g, were housed in single cages.

[0085] Breeding environment: room temperature 20-26℃, relative humidity controlled at 40-70%.

[0086] 1.2 Medication

[0087] The Chinese medicine composition was prepared according to the method of Example 1 and provided by Jiangsu Kangyuan Pharmaceutical Co., Ltd.; fluoxetine hydrochloride capsules were purchased from Suzhou Zhonghua Pharmaceutical Co., Ltd., 20 mg / capsule.

[0088] Chloral hydrate (Sinopharm Chemical Reagent Co., Ltd., batch number 20200320); rat 5-HT enzyme-linked immunosorbent assay kit (Wuhan Huamei Biological Company, catalog number CSB-E08364R).

[0089] 1.3 Instruments

[0090] Electronic analytical balance, METTLER TOLEDO, model: ME303E; high-speed refrigerated centrifuge, Eppendorf, model: BY-20; multifunctional enzyme plate reader, PerkinElmer P, model: Enspire; small animal behavior instrument, Reward, model: SMART3.0.

[0091] 2. Dosage design

[0092] The unit dosage of Shuhe is 2051g of crude drug. After water extraction, concentration, and drying, approximately 738g of dry paste powder is obtained. Excipients are added and granulated to obtain 1000g of the finished product. Each 10g bag contains 20.5g of crude drug. Taking 6 bags per day (twice a day, 3 bags at a time) is equivalent to taking 123g of crude drug per person per day. According to the body surface area conversion method, the equivalent dose for rats is 123g / 60kg*6.2=12.71g crude drug / kg. This dose is set as the medium dose group, while the low dose group receives 6.36g crude drug / kg and the high dose group receives 25.42g crude drug. Administration is by gavage at 0.2mL / 10g once a day.

[0093] The daily dosage of fluoxetine hydrochloride capsules is 40 mg / day. According to the body surface area conversion method, the equivalent dose for rats is 40 mg / 60 kg*6.2=4.13 mg / kg.

[0094] 3. Experimental Methods

[0095] SD rats were adaptively fed for 7 days with free access to feed and water and randomly divided into a normal control group, a model control group, a fluoxetine control group, and high-, medium-, and low-dose groups of the Chinese medicine composition, with 10 rats in each group.

[0096] All animals in the stress groups were subjected to a 21-day course of mild, unpredictable stimulation according to the CMS stimulation sequence (see Table 3). Starting on day 22, each treatment group received oral administration of 1 mL / 100 g of the drug once daily for 14 consecutive days. The normal control and model control groups were given normal saline under the same conditions.

[0097] Table 3 Types of stress implemented in the CMS model

[0098]

[0099] Testing Indicators: ① Open Field Test: 24 hours after the last administration, the total distance traveled and the time spent in the center zone of each rat within the open field chamber were measured. ② After autopsy, 5 mL of blood was collected from the femoral artery of the rats. Plasma samples were collected and 5-HT concentrations were measured using an enzyme-linked immunosorbent assay (ELISA) kit.

[0100] 4. Statistical methods

[0101] The results were statistically analyzed using One-Way ANOVA test.

[0102] 5. Experimental Results

[0103] 5.1 Effects on open field behavior in rats with chronic mild stress depression

[0104] Rats were stimulated with chronic mild stress for 21 days. Twenty-four hours after modeling, the Chinese medicine composition was administered for 14 days. Compared with the normal control group, the time spent in the central area and the total distance moved in the open field behavior test of the rats were significantly reduced (P<0.0001). Compared with the model control group, the time spent in the central area and the total distance moved in the high- and medium-dose groups were significantly increased (P<0.0001). See Table 4.

[0105] Table 4: Effects on total movement distance and center area residence time in open field behavior of CMS depression rat model

[0106]

[0107]

[0108] Note: Compared with the normal control group, #### P<0.0001; compared with the model control group, **** P<0.0001.

[0109] 5.2 Rats with chronic mild stress depression model

[0110] Rats were subjected to chronic mild stress for 21 days. Twenty-four hours after modeling, the Chinese medicine composition was administered for 14 days. Plasma 5-HT levels in the model control group decreased significantly, with a statistically significant difference (P < 0.0001). Plasma 5-HT levels in the high- and medium-dose groups increased significantly compared to the model control group, with statistically significant differences (P < 0.01, P < 0.0001). See Table 5.

[0111] Table 5: Effects on 5-HT in plasma of CMS depression rat model

[0112]

[0113]

[0114] Note: Compared with the normal control group, #### P<0.0001; compared with the model control group, ** P<0.01, **** P<0.0001.

[0115] 6. Experimental Conclusion

[0116] The Chinese herbal composition at 25.42 and 12.71 g / kg of crude drug can significantly increase the total moving distance and the time spent in the center area in the open field behavioral experiment, and increase the 5-HT content in plasma, indicating that the Chinese herbal composition has a certain therapeutic effect on the rat depression model induced by chronic mild stress.

[0117] 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 depression, 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, drying, and forming 1000 g. 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 depression includes improving abnormalities in neurobiochemical indicators.

10. The use according to claim 9, characterized in that The abnormalities of improving neurobiochemical indicators include: (I) Improve the social ability of mice with social frustration depression model; (II), reducing the level of corticosterone in serum; (III) increasing the total distance traveled and the time spent in the center area in an open field behavioral test; and / or (IV) Increase the 5-HT content in plasma.

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