A traditional Chinese medicine composition for treating insomnia, its preparation method and application

Abstract

The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating insomnia, its preparation method and application. The present invention provides a traditional Chinese medicine composition for treating insomnia, which comprises the following raw materials in parts by mass: 20-30 parts of mulberry, 15-18 parts of rose, 15-18 parts of asarum, 6-12 parts of chuanxiong, 6-12 parts of Chinese yam, 2-5 parts of polygala root, and 2-5 parts of honeysuckle flower. The present invention adopts pure traditional Chinese medicine herbal raw materials. According to the theoretical characteristics of traditional Chinese medicine with overall and syndrome-differentiating features, following the principles of "sovereign", "minister", "assistant" and "guide", taking mulberry as the sovereign drug, taking rose and asarum together as the minister drugs, taking chuanxiong and Chinese yam together as the assistant drugs, and taking polygala root and honeysuckle flower together as the guide drugs. When all the drugs are combined, they have the effect of calming the nerves and helping sleep, can significantly improve insomnia symptoms, and have no toxic and side effects.

Description

Technical Field

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

[0002] Insomnia refers to a sleep disorder in which a person is unable to fall asleep or maintain a sleep state, resulting in insufficient sleep. It is manifested as difficulty in falling asleep, intermittent and incoherent sleep, waking up prematurely, and being unable to continue sleeping after waking up, resulting in insufficient sleep and general fatigue. The treatment of insomnia aims to enable a person's effective sleep time to reach the average sleep time corresponding to their age group, so as to achieve the effect of eliminating fatigue and restoring mental and physical states. Hypnotic drugs are the main drug intervention strategies for treating insomnia.

[0003] There are many drugs for treating insomnia on the market. Many insomnia patients affected by insomnia for a long time will choose Western medicine treatment. The most commonly used hypnotics include benzodiazepine drugs and non-benzodiazepine drugs. Most of these drugs are chemically synthesized and often cause side effects such as amnesia and dizziness, and have a low safety factor and a single therapeutic effect. Seeking therapeutic drugs and treatment plans from traditional Chinese medicine has become one of the important research directions in the field of insomnia prevention and treatment. Traditional Chinese medicine for treating insomnia is neither addictive, nor has dependence and drug resistance, nor withdrawal symptoms. However, many existing traditional Chinese medicines fail to achieve the expected effect, and their curative effects are not satisfactory. Summary of the Invention

[0004] The purpose of the present invention is to solve the problems of inaccurate curative effect and slow onset of existing insomnia drugs, and provide a traditional Chinese medicine composition for treating insomnia, its preparation method and application, so as to improve the treatment effect of insomnia.

[0005] The present invention provides a traditional Chinese medicine composition for treating insomnia, comprising the following raw materials in parts by mass: 20-30 parts of mulberry, 15-18 parts of rose, 15-18 parts of asarum, 6-12 parts of chuanxiong, 6-12 parts of Chinese yam, 2-5 parts of polygala, and 2-5 parts of honeysuckle.

[0006] Preferably, it comprises the following raw materials in parts by mass: 23-28 parts of mulberry, 16-18 parts of rose, 16-18 parts of asarum, 6-10 parts of chuanxiong, 6-10 parts of Chinese yam, 3-4 parts of polygala, and 3-5 parts of honeysuckle.

[0007] Preferably, it comprises the following raw materials in parts by mass: 25 parts of mulberry, 16 parts of rose, 16 parts of asarum, 8 parts of chuanxiong, 8 parts of Chinese yam, 3 parts of polygala, and 3 parts of honeysuckle.

[0008] Preferably, the dosage form of the traditional Chinese medicine composition is decoction or aqueous solution.

[0009] The present invention also provides a preparation method of the traditional Chinese medicine composition described in the above technical solution, which includes the following steps:

[0010] Mix the raw materials with the first component of water, carry out the first decoction, and collect the first decoction liquid and the medicinal residues;

[0011] Mix the medicinal residues with the second component of water, carry out the second decoction, and collect the second decoction liquid;

[0012] Mix the first decoction liquid and the second decoction liquid, and concentrate to obtain the traditional Chinese medicine composition.

[0013] Preferably, the mass-volume ratio of the raw materials to the first component of water is 1 g:(10-15) mL.

[0014] Preferably, the first decoction includes: decocting with slow fire for 1-2 h.

[0015] Preferably, the mass-volume ratio of the medicinal residues to the second component of water is 1 g:(5-8) mL.

[0016] Preferably, the second decoction includes: decocting with slow fire until boiling and then decocting with strong fire for 15-20 min.

[0017] The present invention also provides the application of the traditional Chinese medicine composition described in the above technical solution in the preparation of products for treating insomnia.

[0018] Beneficial effects:

[0019] The present invention provides a traditional Chinese medicine composition for treating insomnia, which includes the following raw materials in parts by mass: 20-30 parts of mulberry, 15-18 parts of rose, 15-18 parts of asarum, 6-12 parts of chuanxiong, 6-12 parts of Chinese yam, 2-5 parts of polygala, and 2-5 parts of honeysuckle. The present invention adopts pure traditional Chinese medicine herbal raw materials, and based on the theoretical characteristics of traditional Chinese medicine with overall and dialectical nature, follows the principles of "emperor", "minister", "assistant", and "guide". Taking mulberry as the emperor medicine, rose and asarum together as the minister medicine, chuanxiong and Chinese yam together as the assistant medicine, and polygala and honeysuckle together as the guide medicine. The combination of various medicines has the effect of calming the nerves and helping sleep, can significantly improve insomnia symptoms, and has no toxic and side effects. Specific embodiments

[0020] The present invention provides a traditional Chinese medicine composition for treating insomnia, which includes the following raw materials in parts by mass: 20-30 parts of mulberry, 15-18 parts of rose, 15-18 parts of asarum, 6-12 parts of chuanxiong, 6-12 parts of Chinese yam, 2-5 parts of polygala, and 2-5 parts of honeysuckle.

[0021] In the present invention, calculated by parts by mass, the raw materials of the traditional Chinese medicine composition include 20-30 parts of mulberry, preferably 23-28 parts, and more preferably 25 parts.

[0022] In the present invention, based on the parts by mass of the mulberries, the raw materials of the traditional Chinese medicine composition include 15 - 18 parts of rose flowers, preferably 16 - 18 parts, and more preferably 16 parts.

[0023] In the present invention, based on the parts by mass of the mulberries, the raw materials of the traditional Chinese medicine composition include 15 - 18 parts of asarum, preferably 16 - 18 parts, and more preferably 16 parts.

[0024] In the present invention, based on the parts by mass of the mulberries, the raw materials of the traditional Chinese medicine composition include 6 - 12 parts of chuanxiong rhizome, preferably 6 - 10 parts, and more preferably 8 parts.

[0025] In the present invention, based on the parts by mass of the mulberries, the raw materials of the traditional Chinese medicine composition include 6 - 12 parts of Chinese yam, preferably 6 - 10 parts, and more preferably 8 parts.

[0026] In the present invention, based on the parts by mass of the mulberries, the raw materials of the traditional Chinese medicine composition include 2 - 5 parts of polygala root, preferably 3 - 4 parts, and more preferably 3 parts.

[0027] In the present invention, based on the parts by mass of the mulberries, the raw materials of the traditional Chinese medicine composition include 3 - 5 parts of honeysuckle flowers, preferably 3 - 4 parts, and more preferably 3 parts.

[0028] The present invention adopts pure traditional Chinese medicine herbal raw materials, with mulberries as the monarch drug. Mulberries are sweet, sour, and cold, soothe the liver and relieve depression, and nourish qi and blood. Rose flowers and asarum together serve as the ministerial drugs. Rose flowers are sweet and slightly bitter, tonifying qi and nourishing blood. Asarum is pungent and warm, dispelling wind, cold, promoting diuresis, and opening orifices. Chuanxiong rhizome and Chinese yam together serve as the adjuvant drugs. Chuanxiong rhizome is pungent and warm, promoting blood circulation and qi movement, dispelling wind and relieving pain. Chinese yam is sweet and neutral, tonifying the middle - energizer and replenishing qi. Polygala root and honeysuckle flowers together serve as the guiding drug. Polygala root is warm in nature, bitter and pungent in taste, opening the heart qi and calming the mind. Honeysuckle flowers are sweet and cold, clearing heat and relieving the exterior. Based on the theoretical characteristics of traditional Chinese medicine of wholeness and syndrome differentiation, the present invention follows the principles of "monarch", "minister", "adjuvant", and "guiding". When all the drugs are combined, they have the effect of calming the mind and helping sleep, can significantly improve insomnia symptoms, and have no toxic side effects.

[0029] In the present invention, the dosage form of the traditional Chinese medicine composition is preferably decoction or aqueous solution.

[0030] The present invention also provides a preparation method of the traditional Chinese medicine composition described in the above technical solution, including the following steps:

[0031] Mix the raw materials with the first component of water and conduct the first decoction, collecting the first decoction liquid and the medicinal residues;

[0032] Mix the medicinal residues with the second component of water and conduct the second decoction, collecting the second decoction liquid;

[0033] Mix the first decoction liquid and the second decoction liquid, and concentrate them to obtain the traditional Chinese medicine composition.

[0034] In the present invention, the raw materials and the first component water are mixed and subjected to the first decoction, and the first decoction liquid and the medicinal residues are collected. In the present invention, the mass-volume ratio of the raw materials to the first component water is preferably 1 g:(10-15) mL, and more preferably 1 g:10 mL. The first decoction in the present invention preferably includes: simmering for 1-2 h, and more preferably simmering for 1.5 h.

[0035] After obtaining the first decoction liquid and the medicinal residues, in the present invention, the medicinal residues and the second component water are mixed and subjected to the second decoction, and the second decoction liquid is collected. In the present invention, the mass-volume ratio of the medicinal residues to the second component water is preferably 1 g:(5-8) mL, and more preferably 1 g:6 mL. The second decoction in the present invention preferably includes: simmering until boiling and then boiling strongly for 15-20 min, and more preferably simmering until boiling and then boiling strongly for 16 min.

[0036] After obtaining the second decoction liquid, in the present invention, the first decoction liquid and the second decoction liquid are mixed and concentrated to obtain the traditional Chinese medicine composition. In the present invention, the concentration is preferably concentrated into a water decoction containing 2-4 g / mL of raw materials, and more preferably concentrated into a water decoction containing 3 g / mL of raw materials. The present invention has no strict requirements on the concentration method, and the conventional concentration methods in the art can be used, such as evaporation concentration.

[0037] The present invention also provides the application of the traditional Chinese medicine composition described in the above technical solution in the preparation of products for treating insomnia. In the present invention, the product preferably includes drugs. The traditional Chinese medicine composition provided by the present invention has the effect of calming the nerves and helping sleep, can significantly improve insomnia symptoms, and has no toxic and side effects.

[0038] In order to further illustrate the present invention, the following examples are used to describe in detail a traditional Chinese medicine composition for treating insomnia, its preparation method and application provided by the present invention, but they cannot be understood as limiting the protection scope of the present invention.

[0039] Example 1

[0040] (1) Prepare materials according to the following mass parts: 25 parts of mulberry, 16 parts of rose, 16 parts of asarum, 8 parts of chuanxiong, 8 parts of Chinese yam, 3 parts of polygala and 3 parts of honeysuckle;

[0041] (2) Mix the above raw materials and water in a ratio of 1 g:12 mL, simmer for 1.5 h, and then collect the decoction liquid and the medicinal residues;

[0042] (3) Mix the medicinal residues obtained in step (2) and water in a ratio of 1 g:6 mL, simmer until boiling and then boil strongly for 15 min, and collect the decoction liquid;

[0043] (4) Combine the decoction liquids from steps (2) and (3), and concentrate them into a water decoction containing 3 g / mL of the raw materials to obtain the traditional Chinese medicine composition.

[0044] Example 2

[0045] (1) Prepare the raw materials according to the following parts by mass: 30 parts of mulberry, 18 parts of rose, 18 parts of asarum, 12 parts of chuanxiong, 12 parts of Chinese yam, 5 parts of polygala, and 5 parts of honeysuckle;

[0046] (2) Mix the above raw materials and water in a ratio of 1 g: 15 mL, decoct with slow fire for 2 h, and collect the decoction liquid and the medicinal residues;

[0047] (3) Mix the medicinal residues obtained in step (2) and water in a ratio of 1 g: 8 mL, decoct with slow fire until boiling and then with strong fire for 20 min, and collect the decoction liquid;

[0048] (4) Combine the decoction liquids from steps (2) and (3), and concentrate them into a water decoction containing 4 g / mL of the raw materials to obtain the traditional Chinese medicine composition.

[0049] Example 3

[0050] (1) Prepare the raw materials according to the following parts by mass: 20 parts of mulberry, 15 parts of rose, 15 parts of asarum, 6 parts of chuanxiong, 6 parts of Chinese yam, 2 parts of polygala, and 2 parts of honeysuckle;

[0051] (2) Mix the above raw materials and water in a ratio of 1 g: 10 mL, decoct with slow fire for 1 h, and collect the decoction liquid and the medicinal residues;

[0052] (3) Mix the medicinal residues obtained in step (2) and water in a ratio of 1 g: 5 mL, decoct with slow fire until boiling and then with strong fire for 15 min, and collect the decoction liquid;

[0053] (4) Combine the decoction liquids from steps (2) and (3), and concentrate them into a water decoction containing 2 g / mL of the raw materials to obtain the traditional Chinese medicine composition.

[0054] Comparative Example 1

[0055] Same as Example 1, the only difference is that it does not contain mulberry, and the mass fraction of rose is 23 parts, and the mass fraction of asarum is 23 parts.

[0056] Comparative Example 2

[0057] Same as Example 1, the only difference is that the mass fraction of rose is 25 parts, and the mass fraction of mulberry is 16 parts.

[0058] Comparative Example 3

[0059] Same as Example 1, the only difference is that 25 parts of mulberries are replaced with 25 parts of wild jujube seeds.

[0060] Comparative Example 4

[0061] Same as Example 1, the only difference is that Asarum sieboldii is not included, and the mass fraction of rose flowers is 32 parts.

[0062] Comparative Example 5

[0063] Same as Example 1, the only difference is that Chuanxiong rhizome is not included, and the mass fraction of Chinese yams is 16 parts.

[0064] Comparative Example 6

[0065] Same as Example 1, the only difference is that honeysuckle is not included, and the mass fraction of polygala roots is 6 parts.

[0066] Comparative Example 7

[0067] Same as Example 1, the only difference is that after preparing the raw materials according to the mass fraction, the raw materials are subjected to two times of heating under reflux extraction, and concentrated into an extract containing 4 g / mL of raw materials to obtain the traditional Chinese medicine composition.

[0068] Test Example 1

[0069] Animal experiment

[0070] 1. Experimental animals and grouping

[0071] 65 SPF-grade healthy male Kunming mice, 6 - 8 weeks old, weighing (20 ± 2) g, [Changchun Yisi Experimental Animal Center, animal certificate number SCXK(Ji) 2020 - 0001], normally raised, temperature 20 - 25 °C, humidity 40% - 60%, normal day and night cycle.

[0072] The experimental animals were randomly divided into a negative control group, control groups 1 - 7, experimental groups 1 - 3, a model group, and a positive control group, with 5 mice in each group.

[0073] 2. Establishment of animal model

[0074] After the animals were normally raised and adapted to the environment for 7 days, at a fixed time every day, in control groups 1 - 7, experimental groups 1 - 3, and the positive control group, 400 mg / kg PCPA suspension (PCPA suspension is prepared by adding powder to water to obtain 30 mg / mL) was intraperitoneally injected continuously for 2 days. The control group was injected with an equal volume of normal saline. After 2 days, the states of each group were observed. The results showed that except for the negative control group, the mice in the other treatment groups showed phenomena such as circadian rhythm disorder and mutual attack, indicating that the insomnia model was successfully established.

[0075] 3. Administration

[0076] Negative control group: intragastrically administered normal saline continuously for 7 days;

[0077] Model group: Intragastrically administered normal saline for 7 consecutive days;

[0078] Positive control group: Intragastrically administered estazolam at a dose of 0.1 mg / (kg·d) for 7 consecutive days;

[0079] Control group 1: Intragastrically administered the traditional Chinese medicine composition obtained in Comparative Example 1 at a dose of 1 mL / (kg·d) for 7 consecutive days;

[0080] Control group 2: Intragastrically administered the traditional Chinese medicine composition obtained in Comparative Example 2 at a dose of 1 mL / (kg·d) for 7 consecutive days;

[0081] Control group 3: Intragastrically administered the traditional Chinese medicine composition obtained in Comparative Example 3 at a dose of 1 mL / (kg·d) for 7 consecutive days;

[0082] Control group 4: Intragastrically administered the traditional Chinese medicine composition obtained in Comparative Example 4 at a dose of 1 mL / (kg·d) for 7 consecutive days;

[0083] Control group 5: Intragastrically administered the traditional Chinese medicine composition obtained in Comparative Example 5 at a dose of 1 mL / (kg·d) for 7 consecutive days;

[0084] Control group 6: Intragastrically administered the traditional Chinese medicine composition obtained in Comparative Example 6 at a dose of 1 mL / (kg·d) for 7 consecutive days;

[0085] Control group 7: Intragastrically administered the traditional Chinese medicine composition obtained in Comparative Example 7 at a dose of 1 mL / (kg·d) for 7 consecutive days;

[0086] Experimental group 1: Intragastrically administered the traditional Chinese medicine composition obtained in Example 1 at a dose of 1 mL / (kg·d) for 7 consecutive days;

[0087] Experimental group 2: Intragastrically administered the traditional Chinese medicine composition obtained in Example 2 at a dose of 1 mL / (kg·d) for 7 consecutive days;

[0088] Experimental group 3: Intragastrically administered the traditional Chinese medicine composition obtained in Example 3 at a dose of 1 mL / (kg·d) for 7 consecutive days;

[0089] 4. Observation of behavioral status and determination of body weight changes

[0090] The mental state, behavior, etc. of the mice in each group were observed before and after modeling and after treatment, and the body weights of the mice before and after modeling and after the last administration were recorded. The increase in body weight of the mice was calculated. The results showed that the states of the mice in each group were significantly different after modeling. The mice in the negative control group were in normal mental state with obvious circadian rhythm; the mice in the model group were irritable, aggressive, and sensitive to external stimuli; the states of the mice in each group gradually returned to normal after treatment. The body weight of the mice in the negative control group continued to increase steadily, while the body weights of the mice in the other groups showed a trend of first decreasing and then increasing. The results are shown in Table 1.

[0091] Table 1 Mouse body weight under different treatment methods (g, n = 5, x±s)

[0092]

[0093]

[0094] Note: Different lowercase letters indicate significant differences, p < 0.05.

[0095] It can be seen from Table 1 that compared with the negative control group, the body weight of mice in the model group was significantly reduced (P < 0.05); compared with the model group, the body weights of mice in Control Groups 1 - 7, Experimental Groups 1 - 3, and the positive control group were significantly increased (P < 0.05). However, compared with Control Groups 1 - 7, the body weight increase effect of Experimental Groups 1 - 3 was more significant (P < 0.05). The traditional Chinese medicine composition provided by the present invention has a resistance effect on the decreased body weight gain rate of insomnia mice.

[0096] 5. Determination of sleep latency and sleep time

[0097] One hour after the last administration to mice in each treatment group, sodium pentobarbital was injected at a dose of 45 mg / kg of mouse body weight, and the sleep latency and sleep time of the mice were recorded. During the experiment, it was necessary to keep quiet.

[0098] Table 2 Sleep latency and sleep time of mice under different treatment methods (min, n = 5, x±s)

[0099]

[0100]

[0101] Note: Different lowercase letters in the same column indicate significant differences, p < 0.05; different capital letters in the same column indicate significant differences, p < 0.05.

[0102] It can be seen from Table 2 that compared with the negative control group, the sleep latency of mice in the model group was significantly increased (P < 0.05), and the continuous sleep time was significantly reduced (P < 0.05); compared with the model group, the sleep latency of mice in Control Groups 1 - 7, Experimental Groups 1 - 3, and the positive control group was significantly reduced (P < 0.05). However, compared with Control Groups 1 - 7, the sleep latency of mice in Experimental Groups 1 - 3 was reduced more significantly (P < 0.05); compared with the model group, the continuous sleep time of mice in Control Groups 1 - 7, Experimental Groups 1 - 3, and the positive control group was significantly increased (P < 0.05). However, compared with Control Groups 1 - 7, the continuous sleep time of mice in Experimental Groups 1 - 3 was increased more significantly (P < 0.05). The traditional Chinese medicine composition provided by the present invention has the effects of shortening the sleep latency and prolonging the sleep time of insomnia mice.

[0103] Test Example 2

[0104] Clinical trial

[0105] (1) Referring to the "Diagnosis and Treatment Guidelines for Insomnia in Chinese Adults", 300 patients diagnosed with insomnia in the Third People's Hospital of Ganzhou from January 2020 to December 2023 were randomly selected and divided into a control group, Treatment Group 1, and Treatment Group 2, with 100 cases in each treatment group. Among them, the average age of the control group was 62 ± 3 years old, the average age of Treatment Group 1 was 59 ± 2 years old, and the average age of Treatment Group 2 was 61 ± 2 years old. The insomnia symptoms and the degree of insomnia development of the three groups of patients were similar, without significant differences, and were comparable.

[0106] (2) Treatment method

[0107] Taking two weeks as a course of treatment, after the control group and Treatment Groups 1 - 2 were withdrawn from drug intervention, the sleep conditions of the patients were observed. Among them,

[0108] Control group: The test patients took diazepam orally before going to bed every day, with a dosage of 5 mg / time;

[0109] Treatment Group 1: The test patients took 100 mL of the traditional Chinese medicine composition obtained in Example 1 before going to bed every day;

[0110] Treatment Group 2: The test patients took 100 mL of the traditional Chinese medicine composition obtained in Comparative Example 1 before going to bed every day;

[0111] During the treatment process, the patients in each treatment group developed good sleep habits, went to bed on time, refused to drink coffee, strong tea, etc. before going to bed, and avoided watching TV dramas and novels that affected emotions.

[0112] (3) Efficacy criteria

[0113] Cured: All symptoms disappeared, and there was no insomnia for 20 consecutive days;

[0114] Improved: Symptoms were relieved, and the number of insomnia times within 20 days was less than 10 times;

[0115] Ineffective: Symptoms showed no change before and after treatment

[0116] (4) After the treatment was completed, the curative effects of different treatment groups were compared. The results showed that compared with the control group and Treatment Group 2, Treatment Group 1 could significantly improve the treatment effect of insomnia (Table 3).

[0117] Table 3 Comparison results of clinical curative effects

[0118] Group Number of cured patients / Cure rate Number of improved patients / Improvement rate Number of ineffective patients / Ineffectiveness rate Total effective rate Control group 32(32％) 41(41％) 27(27％) 73％ Treatment group 1 72(72％) 24(24％) 4(4％) 96％ Treatment group 2 49(49％) 35(35％) 16(16％) 84％

[0119] Note: The total effective rate = cure rate + improvement rate.

[0120] It can be seen from the above content that the traditional Chinese medicine composition provided by the present invention has the effect of calming the nerves and helping sleep, can significantly improve insomnia symptoms, and has no toxic and side effects.

[0121] Although the above embodiments have described the present invention in detail, they are only some embodiments of the present invention, rather than all embodiments. People can also obtain other embodiments based on these embodiments without creative efforts, and these embodiments all fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating insomnia, characterized in that, It is made from the following raw materials in parts by mass: 20 - 30 parts of mulberry, 15 - 18 parts of rose, 15 - 18 parts of asarum, 6 - 12 parts of chuanxiong, 6 - 12 parts of Chinese yam, 2 - 5 parts of polygala, and 2 - 5 parts of honeysuckle flower.

2. The traditional Chinese medicine composition according to claim 1, characterized in that It is made from the following raw materials in parts by mass: 23 - 28 parts of mulberry, 16 - 18 parts of rose, 16 - 18 parts of asarum, 6 - 10 parts of chuanxiong, 6 - 10 parts of Chinese yam, 3 - 4 parts of polygala, and 3 - 5 parts of honeysuckle flower.

3. The traditional Chinese medicine composition according to claim 2, wherein, It is made from the following raw materials in parts by mass: 25 parts of mulberry, 16 parts of rose, 16 parts of asarum, 8 parts of chuanxiong, 8 parts of Chinese yam, 3 parts of polygala, and 3 parts of honeysuckle flower.

4. The traditional Chinese medicine composition according to any one of claims 1 to 3, characterized in that The dosage form of the traditional Chinese medicine composition is decoction or aqueous solution.

5. The preparation method of the traditional Chinese medicine composition according to any one of claims 1 to 4, characterized in that, It includes the following steps: Mix the raw materials with the first component of water and conduct the first decoction, collecting the first decoction liquid and the medicinal residues. Mix the medicinal residues with the second component of water and conduct the second decoction, collecting the second decoction liquid. Mix the first decoction liquid and the second decoction liquid, and concentrate to obtain the traditional Chinese medicine composition.

6. The preparation method according to claim 5, characterized in that, The mass - volume ratio of the raw materials to the first component of water is 1 g:(10 - 15) mL.

7. The preparation method according to claim 5, characterized in that, The first decoction includes: decocting with slow fire for 1 - 2 h.

8. The preparation method according to claim 5, characterized in that, The mass - volume ratio of the medicinal residues to the second component of water is 1 g:(5 - 8) mL.

9. The preparation method according to claim 5, characterized in that, The second decoction includes: decocting with slow fire until boiling and then decocting with strong fire for 15 - 20 min.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 - 4 or the traditional Chinese medicine composition obtained by the preparation method according to any one of claims 5 - 9 in the preparation of a product for treating insomnia.

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