Traditional Chinese medicine composition for treating depression and insomnia and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating depression and insomnia and application thereof, and belongs to the field of traditional Chinese medicines. The traditional Chinese medicine composition comprises the following raw material components in parts by weight: 10-15 parts of fermented soybean, 10-30 parts of lily, 10-15 parts of red wolfberry, 10-15 parts of radix puerariae, 10-30 parts of cistanche, 10-15 parts of longan aril, 10-30 parts of jujube, 9-30 parts of oyster, 10-15 parts of pawpaw, 3-10 parts of fingered citron, 5-15 parts of dogwood, 6-10 parts of fried gardenia, 15-30 parts of light wheat and 3-10 parts of honey-fried licorice root. Animal experiments and clinical tests prove that the traditional Chinese medicine composition can improve insomnia and depression symptoms at the same time. The traditional Chinese medicine composition has the overall regulation advantage of traditional Chinese medicine and the controllability of a modern preparation, and a safe and efficient treatment scheme is provided for depression and insomnia.

Description

Technical Field

[0001] The present invention relates to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating depression and insomnia and its application. Background Art

[0002] Insomnia, as a common mental illness, is a common sleep problem in clinical practice. It mostly shows recurrent and chronic persistence, which not only seriously affects daytime social functions, reduces work efficiency and alertness, but also is closely related to cardiovascular diseases, heart diseases, various neurological and mental diseases in the long-term development, posing a great threat to people's health.

[0003] In China, the problem of insomnia is also severe. The traditional Chinese medicine classic "Huangdi Neijing" refers to insomnia as "insomnia", "inability to close eyes", "inability to sleep", "inability to lie down", etc. Epidemiological studies show that there are more than 120 million chronic insomnia patients in China. Long-term sleep disorders will significantly increase the risks of physical diseases such as cardiovascular and cerebrovascular diseases, mental diseases such as anxiety and depression, as well as drug dependence or abuse.

[0004] It is worth noting that the health problem of senile insomnia is particularly prominent. Data shows that as of the end of 2017, the elderly population aged 60 and above in China accounted for 17.3% of the total population, and the aging of the population has intensified. Among the elderly population aged 60 and above, the prevalence of sleep disorders is as high as 47.2%, and it is directly proportional to age growth, seriously affecting the mental state and health of the elderly. At the same time, with the decline of estrogen, women will age faster and are more likely to be troubled by emotional problems such as depression. Summary of the Invention

[0005] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating depression and insomnia and its application to solve the problems existing in the above-mentioned prior art. The traditional Chinese medicine composition provided by the present invention can not only effectively improve the problem of insomnia, but also has the effect of relieving depression.

[0006] To achieve the above purpose, the present invention provides the following solutions:

[0007] The present invention provides a traditional Chinese medicine composition for treating depression and insomnia. The raw material composition is calculated by weight and includes the following components: 10 - 15 parts of fermented soybean, 10 - 30 parts of lily, 10 - 15 parts of red wolfberry, 10 - 15 parts of kudzu root, 10 - 30 parts of cistanche, 10 - 15 parts of longan aril, 10 - 30 parts of Chinese date, 9 - 30 parts of oyster, 10 - 15 parts of papaya, 3 - 10 parts of fingered citron, 5 - 15 parts of cornel, 6 - 10 parts of stir-fried gardenia, 15 - 30 parts of floating wheat, and 3 - 10 parts of roasted licorice.

[0008] Optionally, by weight, the raw material composition comprises the following components: 12 parts of fermented soybean, 15 parts of lily, 11 parts of red wolfberry, 13 parts of kudzu root, 20 parts of cistanche, 13 parts of longan pulp, 25 parts of Chinese date, 15 parts of oyster, 12 parts of papaya, 6 parts of fingered citron, 10 parts of cornel, 8 parts of stir-fried gardenia, 22 parts of floating wheat and 7 parts of roasted licorice root.

[0009] The present invention also provides a preparation method of the traditional Chinese medicine composition, comprising the following steps:

[0010] Clean and remove impurities from the raw materials, and then carry out pulverization treatment to obtain fine raw material powder;

[0011] Dissolve the fine raw material powder in a solvent, then carry out heating extraction, and obtain an extract after filtration;

[0012] Concentrate the extract to obtain a concentrated solution, and dry the concentrated solution to obtain the traditional Chinese medicine composition.

[0013] Optionally, the solvent comprises water and an ethanol solution.

[0014] Optionally, when the solvent is water, the mass ratio of the fine raw material powder to the solvent is 1:2.

[0015] Optionally, when the solvent is an ethanol solution, the mass ratio of the fine raw material powder to the solvent is 1:1.

[0016] Optionally, the heating extraction is carried out in 2 cycles. After the first heating extraction is completed, collect the filtrate as the first filtrate. Take the filter residue and add the solvent again for the second heating extraction. After the extraction is completed, collect the filtrate as the second filtrate, and combine the two filtrates to obtain the extract.

[0017] Optionally, the relative density of the concentrated solution is 1.10 - 1.20.

[0018] The present invention also provides an application of the traditional Chinese medicine composition in the preparation of a drug for treating depressive insomnia.

[0019] Optionally, the dosage form of the drug comprises granules, tablets and pills.

[0020] The present invention discloses the following technical effects:

[0021] In the traditional Chinese medicine composition of the present invention, the monarch drugs (soybean sprouts and lily) clear heat and relieve depression, nourish yin and soothe the nerves; the minister drugs (red wolfberry, kudzu root, etc.) supplement qi, blood, yin and yang; the assistant and guide drugs (fried gardenia, roasted licorice, etc.) regulate the properties of the drugs, forming a synergistic effect of "clearing heat to nourish the heart and tonifying deficiency to soothe the nerves", and at the same time improving insomnia and depressive symptoms. Animal experiments show that it significantly prolongs the sleep duration (6.2 hours / day) and increases the proportion of deep sleep (35%), and the antidepressant effect (the immobile time in the forced swimming test is reduced to 100 seconds) is better than that of the control group (180 seconds). Clinical trials show that after patients take it, the scores of traditional Chinese medicine syndromes are significantly reduced (for example, emotional depression drops from 1.82 to 1.27), and the total effective rate reaches 90%, which is better than that of the diazepam control group (63%). In particular, it significantly improves concurrent symptoms such as dreaminess and easy waking, loss of appetite, etc., and no obvious side effects are reported.

[0022] The present invention combines the advantages of the overall regulation of traditional Chinese medicine and the controllability of modern preparations, providing a safe and efficient treatment plan for depression and insomnia, especially suitable for high-risk populations such as the elderly and menopausal women. Detailed Description of the Invention

[0023] The various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, characteristics, and embodiments of the present invention.

[0024] It should be understood that the terms used in the present invention are only for describing specific embodiments and are not intended to limit the present invention. In addition, for the numerical ranges in the present invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any intermediate value within any stated value or stated range, as well as each smaller range between any other stated value or intermediate value within the stated range, is also included in the present invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0025] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present invention pertains. Although the present invention only describes the preferred methods and materials, any methods and materials similar or equivalent to those described herein can also be used in the implementation or testing of the present invention. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials related to the documents. In case of conflict with any incorporated document, the content of this specification shall prevail.

[0026] Without departing from the scope or spirit of the present invention, various improvements and changes can be made to the specific embodiments of the present invention specification, which are obvious to those skilled in the art. Other embodiments obtained from the specification of the present invention are obvious to those skilled in the art. The specification and embodiments of the present invention are only exemplary.

[0027] As used herein, terms such as "comprising", "including", "having", "containing", etc. are all open-ended terms, meaning including but not limited to.

[0028] The present invention provides a traditional Chinese medicine composition for treating depression and insomnia. The raw material composition is calculated by weight and includes the following components: 10 - 15 parts of fermented soybean, 10 - 30 parts of lily, 10 - 15 parts of red wolfberry, 10 - 15 parts of kudzu root, 10 - 30 parts of cistanche, 10 - 15 parts of longan aril, 10 - 30 parts of Chinese date, 9 - 30 parts of oyster, 10 - 15 parts of papaya, 3 - 10 parts of fingered citron, 5 - 15 parts of cornel, 6 - 10 parts of stir-fried gardenia, 15 - 30 parts of floating wheat, and 3 - 10 parts of roasted licorice root.

[0029] The compatibility principle of the above prescription: Fermented soybean: Promote the dispersing of stagnated heat and relieve exterior syndrome and vexation; Lily: Nourish yin and moisten the lung, clear the heart and calm the mind. The two together serve as the monarch drugs. One disperses and the other astringes, clearing heat and relieving depression while nourishing yin and calming the mind, laying the core of "clearing heat and nourishing the heart, regulating yin and yang" for the whole prescription. Ministerial drug group: Red wolfberry: Tonify the liver and kidney, benefit essence and improve eyesight; Kudzu root: Generate fluid and relax muscles, promote the ascending of clear yang; Cistanche: Tonify kidney yang and benefit essence and blood; Longan aril + Chinese date: Tonify the heart and spleen, nourish blood and calm the mind. The ministerial drug group mainly focuses on "tonifying deficiency", taking into account qi, blood, yin and yang, forming a three-dimensional support of "nourishing yin without forgetting to warm yang, calming the mind and supplementing qi and blood simultaneously". Assisting drugs: Stir-fried gardenia, clearing heat and purging fire, and preventing the warm supplementation of cistanche and longan aril from generating heat. Floating wheat astringes sweating and relieves vexation, assisting lily to calm the mind and preventing the excessive dispersing of fermented soybean. Assisting drugs include oyster, papaya and fingered citron, calming the mind and activating collaterals, soothing the liver and regulating qi, targeting concurrent syndromes. Cornel assists cistanche in tonifying the kidney and preventing the dissipation of yin fluid. Roasted licorice root serves as the guiding drug, replenishing qi and regulating the middle-jiao, relieving the cold nature of gardenia and fermented soybean. Harmonizing all the drugs and enhancing the synergy of the whole prescription.

[0030] The procurement standards for the above raw materials are as follows:

[0031] Floating wheat: Select plump and non-mildewed floating wheat.

[0032] Stir-fried gardenia: Select high-quality gardenia and conduct frying treatment.

[0033] Fermented soybean: Ensure that the fermented soybean has no peculiar smell and excellent quality.

[0034] Lily: Select lily without spots and with firm texture.

[0035] Kudzu root: Select thick and non-cracked kudzu root.

[0036] Oyster: Use fresh and non-odoriferous oyster.

[0037] Chinese date: Select plump and non-insect-eaten Chinese date.

[0038] Papaya: Select ripe and non-damaged papaya.

[0039] Longan pulp: Fresh and non - deteriorated longan pulp is used.

[0040] Red wolfberry: Select bright - red and impurity - free red wolfberries.

[0041] Mountain cornus: Select mountain cornus without insect damage and of excellent quality.

[0042] Cistanche: Select soft - textured and non - mildewed cistanche.

[0043] Fried licorice root: Ensure that the licorice root has been roasted and is free of impurities.

[0044] Buddha's hand: Select undamaged and high - quality Buddha's hand.

[0045] After the above raw materials are purchased, they are respectively washed to remove impurities and soil. For raw materials that need to be processed, such as stir - fried gardenia fruit, ensure that the processing process meets the standards to achieve the best medicinal effect.

[0046] After the above - mentioned raw materials are washed, they are respectively pulverized to make fine powder. The pulverized raw materials are extracted by water extraction or alcohol extraction process.

[0047] In some embodiments of the present invention, the alcohol extraction process is as follows:

[0048] Add the pulverized fine powder to 75% ethanol solution at a mass ratio of 1:1, heat under reflux for 1 - 2 h and then filter. Collect the filtrate, which is the first filtrate; add the filter residue to 75% ethanol solution at a mass ratio of 1:1, heat under reflux again for 1 - 2 h and then filter. Collect the filtrate, which is the second filtrate;

[0049] Combine the first filtrate and the second filtrate, concentrate under reduced pressure to remove the excess solvent, so that the concentrated solution reaches a relative density of 1.10 - 1.20. After drying the concentrated solution, a dry fine powder is obtained.

[0050] In some embodiments of the present invention, the water extraction process is as follows:

[0051] Add the pulverized fine powder to pure water at a mass ratio of 1:2, heat to boiling, keep boiling for 1 - 2 h and then filter. Collect the filtrate, which is the first filtrate; add the filter residue to pure water at a mass ratio of 1:2, heat to boiling again, keep boiling for 1 - 2 h and then filter. Collect the filtrate, which is the second filtrate;

[0052] Combine the first filtrate and the second filtrate, concentrate under reduced pressure to remove the excess solvent, so that the concentrated solution reaches a relative density of 1.10 - 1.20. After drying the concentrated solution, a dry powder is obtained.

[0053] In some embodiments of the present invention, the dried raw material powder can be further prepared into granules, tablets or pills.

[0054] The traditional Chinese medicine composition of the present invention, its preparation and application will be described in detail with reference to specific embodiments.

[0055] Example 1

[0056] By weight, the raw material composition of the traditional Chinese medicine composition is as follows: 15 parts of Semen Sojae Preparatum, 10 parts of Bulbus Lilii, 15 parts of Fructus Lycii Rubri, 10 parts of Radix Puerariae, 30 parts of Herba Cistanches, 10 parts of Arillus Longan, 30 parts of Fructus Jujubae, 9 parts of Concha Ostreae, 15 parts of Fructus Chaenomelis, 3 parts of Fructus Citri Sarcodactylis, 15 parts of Fructus Corni, 6 parts of Fructus Gardeniae, 30 parts of Fructus Tritici Levis, and 3 parts of Radix Glycyrrhizae Preparata.

[0057] After washing the above raw materials, they are respectively pulverized to form fine powders (particle size 125μm - 180μm).

[0058] The pulverized fine powders are added to pure water at a mass ratio of 1:2, heated to boiling, and boiled for 1 hour before filtration. The filtrate is collected as the first filtrate; the filter residue is added to pure water at a mass ratio of 1:2, heated to boiling again, and boiled for 2 hours before filtration. The filtrate is collected as the second filtrate.

[0059] The first filtrate and the second filtrate are combined and concentrated under reduced pressure (60°C, 0.07MPa) to remove the excess solvent until the concentrated solution reaches a relative density of 1.10. The concentrated solution is dried by a spray dryer to obtain a dry powder.

[0060] The dry powder is prepared into granules.

[0061] Example 2

[0062] By weight, the raw material composition of the traditional Chinese medicine composition is as follows: 10 parts of Semen Sojae Preparatum, 30 parts of Bulbus Lilii, 10 parts of Fructus Lycii Rubri, 15 parts of Radix Puerariae, 10 parts of Herba Cistanches, 15 parts of Arillus Longan, 10 parts of Fructus Jujubae, 30 parts of Concha Ostreae, 10 parts of Fructus Chaenomelis, 10 parts of Fructus Citri Sarcodactylis, 5 parts of Fructus Corni, 10 parts of Fructus Gardeniae, 15 parts of Fructus Tritici Levis, and 10 parts of Radix Glycyrrhizae Preparata.

[0063] After washing the above raw materials, they are respectively pulverized to form fine powders (particle size 125μm - 180μm).

[0064] The pulverized fine powders are added to a 75% ethanol solution at a mass ratio of 1:1, heated under reflux for 1 hour before filtration. The filtrate is collected as the first filtrate; the filter residue is added to a 75% ethanol solution at a mass ratio of 1:1, heated under reflux for 2 hours again before filtration. The filtrate is collected as the second filtrate.

[0065] The first filtrate and the second filtrate are combined and concentrated under reduced pressure (60°C, 0.07MPa) to remove the excess solvent until the concentrated solution reaches a relative density of 1.20. The concentrated solution is dried under vacuum conditions to obtain a dry block, which is pulverized into fine powder.

[0066] Prepare the dried fine powder into pills.

[0067] Example 3

[0068] By weight, the raw material composition of the traditional Chinese medicine composition: 12 parts of fermented soybean, 15 parts of lily, 11 parts of red wolfberry, 13 parts of kudzu root, 20 parts of cistanche, 13 parts of longan pulp, 25 parts of Chinese date, 15 parts of oyster, 12 parts of papaya, 6 parts of fingered citron, 10 parts of cornel, 8 parts of stir-fried gardenia, 22 parts of floating wheat and 7 parts of roasted licorice.

[0069] Wash the above raw materials and then crush them respectively to make fine powder (particle size 125μm - 180μm) powder.

[0070] Add pure water to the crushed fine powder in a mass ratio of 1:2, heat to boiling, continue boiling for 2h and then filter to collect the filtrate, which is the first filtrate; add pure water to the filter residue in a mass ratio of 1:2, heat to boiling again, continue boiling for 1.5h and then filter to collect the filtrate, which is the second filtrate;

[0071] Combine the first filtrate and the second filtrate, concentrate under reduced pressure (60°C, 0.07MPa), remove the excess solvent to make the concentrated solution reach a relative density of 1.15. Dry the concentrated solution under vacuum conditions to obtain a dried block, and crush it into fine powder.

[0072] Prepare the dried fine powder into tablets.

[0073] Comparative Example 1

[0074] Compared with Example 3, the difference is only that the fermented soybean is replaced with wild jujube seed.

[0075] Comparative Example 2 [[ID=Z8]]

[0076] Compared with Example 3, the difference is only that, by weight, 15 parts of polygonatum sibiricum and 15 parts of albizia bark are added to the raw material composition of the traditional Chinese medicine composition.

[0077] Comparative Example 3

[0078] Compared with Example 3, the difference is only that the papaya is removed from the raw material composition of the traditional Chinese medicine composition.

[0079] Comparative Example 4

[0080] Compared with Example 3, the difference is only that, by weight, the raw material composition of the traditional Chinese medicine composition: 20 parts of fermented soybean, 8 parts of lily, 15 parts of red wolfberry, 20 parts of kudzu root, 8 parts of cistanche, 18 parts of longan pulp, 8 parts of Chinese date, 10 parts of oyster, 20 parts of papaya, 15 parts of fingered citron, 3 parts of cornel, 5 parts of stir-fried gardenia, 10 parts of floating wheat and 12 parts of roasted licorice.

[0081] Verification Example 1 Animal Experiment

[0082] 1. Experimental materials

[0083] Experimental animals: 160 SPF-grade mice, half male and half female, with a body weight of 20 - 25 g.

[0084] Drugs: The traditional Chinese medicine compositions prepared in Examples 1 - 3 and Comparative Examples 1 - 4 of the present invention.

[0085] Experimental instruments and reagents: Animal breeding equipment, oral gavage needles, activity monitors, blood collection equipment, biochemical analyzers, etc.

[0086] 2. Experimental methods

[0087] Animal grouping and drug administration: The mice were randomly divided into 8 groups, with 20 mice in each group, half male and half female. Each group was respectively given the traditional Chinese medicine compositions prepared in Examples 1 - 3 and Comparative Examples 1 - 4 and an equal amount of normal saline (control group). The administration method was oral gavage, with a dosage of 25 mg / kg, once a day, for 4 consecutive weeks.

[0088] Sleep quality monitoring: An activity monitor was used to record the sleep duration and the proportion of deep sleep of the mice for 7 consecutive days.

[0089] Behavioral test: After the drug administration was completed, a forced swimming test was conducted to record the immobile time of the mice to evaluate the antidepressant effect.

[0090] 3. Data processing and statistical analysis

[0091] The SPSS statistical software was used to process and analyze the experimental data. One-way analysis of variance (ANOVA) was used for both sleep quality data and behavioral test data, and Tukey's HSD multiple comparison test was conducted afterwards. A P value < 0.05 was considered to indicate a statistically significant difference.

[0092] 4. Actual data and analysis

[0093] The analysis results of the sleep quality and antidepressant effect of the mice in each group are shown in Table 1.

[0094] Table 1 Sleep quality and antidepressant effect of mice in each group

[0095] Group Gavage drug Sleep duration (hours / day) Proportion of deep sleep (%) Immobile time (seconds) 1 Example 1 6.1±0.2 30±2 108±4 2 Example 2 6.0±0.3 33±3 120±10 3 Example 3 6.2±0.2 35±2 100±5 4 Comparative Example 1 6.0±0.2 28±3 150±12 5 Comparative Example 2 5.7±0.4 25±4 105±7 6 Comparative Example 3 5.5±0.3 23±2 120±15 7 Comparative Example 4 5.2±0.2 21±3 130±15 8 Normal saline 5.0±0.5 20±5 180±20

[0096] Sleep quality analysis: Compared with the control group, the sleep duration and the proportion of deep sleep of the mice in each drug administration group increased. The overall improvement of sleep in the mice gavaged with the drugs of Examples 1 - 3 was higher than that of the mice gavaged with the drugs of Comparative Examples 1 - 4.

[0097] Analysis of antidepressant effect: Compared with the control group, the immobile time of mice in each drug administration group decreased, which was consistent with the results of sleep quality analysis. The drugs prepared in Examples 1-3 had better effects than those in Comparative Examples 1-4.

[0098] Based on the comprehensive analysis of sleep quality improvement and antidepressant effect, the overall effect of Example 3 was the most significant. Subsequently, the drug prepared in Example 3 was used for clinical verification.

[0099] Verification of Clinical Effect in Verification Example 2

[0100] 1. General Information

[0101] Forty insomnia patients admitted to Chaoyang District Traditional Chinese Medicine Hospital from April 2015 to April 2016 were selected by random lottery method. (Inclusion criteria: Age: 24 - 67, male-female ratio: 1:2, disease course: 1 - 6 months, 4 patients with mild insomnia, 10 patients with moderate insomnia, 7 patients with severe insomnia; Exclusion criteria: patients with other mental diseases, other genetic diseases or serious diseases, and pregnant women) were divided into an experimental group and a control group. There were 21 patients in the experimental group, including 7 males and 14 females, aged 24 - 67 years, with an average age of (35.5 ± 2.3) years, a disease course of 1 - 6 months, and an average of (3.5 ± 3.2) months, 4 patients with mild insomnia, 10 patients with moderate insomnia, and 7 patients with severe insomnia. There were 19 patients in the control group, including 8 males and 11 females, aged 27 - 68 years, with an average age of (37.5 ± 1.2) years, a disease course of 1 - 8 months, and an average of (4.5 ± 2.1) months, 5 patients with mild insomnia, 12 patients with moderate insomnia, and 2 patients with severe insomnia. There was no statistically significant difference in the general information (age, gender, disease course) between the two groups of patients, P > 0.05, and they were comparable.

[0102] 2. Experimental Method

[0103] Patients in the control group were treated with diazepam, once a day, 5 mg each time, taken before going to bed every night until the symptoms disappeared. Patients in the experimental group took the traditional Chinese medicine composition tablets prepared in Example 3, chewed and taken, 3 times a day, 5 mg each time.

[0104] 3. Observation Indexes

[0105] According to the insomnia diagnosis in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and combined with the symptoms of liver depression and spleen deficiency, the traditional Chinese medicine syndromes were observed by using a grading and quantification scoring method. The Pittsburgh Sleep Quality Index (PSQI) was applied to observe the sleep quality of patients. The higher the score, the worse the sleep quality.

[0106] 4. Efficacy Judgment

[0107] If one can have 6 hours of deep sleep every day and wake up energetic, it is considered cured. If the sleep quality is improved and the daily sleep time increases by more than 3 hours, it is considered markedly effective. If the insomnia symptoms are slightly relieved and the daily sleep time increases by less than 3 hours, it is considered effective. If the insomnia symptoms are not alleviated and tend to worsen, it is considered ineffective.

[0108] 5. Results

[0109] The TCM syndrome scores of the two groups of patients are shown in Table 2. There was no statistically significant difference in the TCM syndrome scores between the two groups before treatment (P > 0.05). After treatment, the score of the experimental group was lower than that of the control group, and the difference between the two groups was statistically significant (P < 0.05).

[0110] Table 2 Comparison of TCM syndrome scores between two groups

[0111]

[0112]

[0113] The comparison of the treatment effects of the two groups of patients is shown in Table 3.

[0114] Table 3 Comparison of treatment effects of two groups of patients (cases, %)

[0115]

[0116] The total effective rate of the experimental group was 90%, and that of the control group was 63%. The treatment effect of the experimental group was better than that of the control group, with statistical significance (P < 0.05).

[0117] The embodiments described above are only used to describe the preferred embodiments of the present invention, and do not limit the scope of the present invention. Without departing from the spirit of the present invention, various modifications and improvements made by those of ordinary skill in the art to the technical solutions of the present invention should fall within the protection scope determined by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating depression and insomnia, characterized in that, The raw material composition, by weight, comprises the following components: 10-15 parts of fermented soybean, 10-30 parts of lily, 10-15 parts of red wolfberry, 10-15 parts of kudzu root, 10-30 parts of cistanche, 10-15 parts of longan aril, 10-30 parts of Chinese date, 9-30 parts of oyster, 10-15 parts of papaya, 3-10 parts of fingered citron, 5-15 parts of cornel, 6-10 parts of stir-fried gardenia, 15-30 parts of floating wheat and 3-10 parts of honey-fried licorice root.

2. The traditional Chinese medicine composition according to claim 1, wherein The raw material composition, by weight, comprises the following components: 12 parts of fermented soybean, 15 parts of lily, 11 parts of red wolfberry, 13 parts of kudzu root, 20 parts of cistanche, 13 parts of longan aril, 25 parts of Chinese date, 15 parts of oyster, 12 parts of papaya, 6 parts of fingered citron, 10 parts of cornel, 8 parts of stir-fried gardenia, 22 parts of floating wheat and 7 parts of honey-fried licorice root.

3. The preparation method of the traditional Chinese medicine composition according to claim 1 or 2, characterized in that, It includes the following steps: After cleaning and removing impurities from the raw materials, perform comminution treatment to obtain fine raw material powder. The fine raw material powder is dissolved in a solvent and then subjected to heating extraction, and the extract is obtained after filtration. The extract is concentrated to obtain a concentrated solution, and the concentrated solution is dried to obtain the traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that The solvent includes water and ethanol solution.

5. The preparation method according to claim 4, characterized in that, When the solvent is water, the mass ratio of the fine raw material powder to the solvent is 1:

2.

6. The preparation method according to claim 4, characterized in that When the solvent is ethanol solution, the mass ratio of the fine raw material powder to the solvent is 1:

1.

7. The preparation method according to claim 3, characterized in that, The heating extraction is carried out in 2 cycles. After the first heating extraction is completed, collect the filtrate as the first filtrate. Take the filter residue and add the solvent again for the second heating extraction. After the extraction is completed, collect the filtrate as the second filtrate, and combine the two filtrates to obtain the extract.

8. The preparation method according to claim 3, characterized in that, The relative density of the concentrated solution is 1.10 - 1.

20.

9. Use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a drug for treating depressive insomnia.

10. The application according to claim 9, wherein The dosage forms of the drug include granules, tablets and pills.

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