A traditional Chinese medicine composition for treating insomnia and a preparation method thereof

Abstract

The present application relates to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating insomnia and a preparation method thereof. The traditional Chinese medicine composition is made of the following raw materials in parts by weight: angelica 10-20 parts, raw rehmannia 10-20 parts, polygala 5-15 parts, poria 10-20 parts, clematis 5-15 parts, pinellia 6-12 parts, prunella 6-12 parts, tribulus terrestris 8-12 parts, raw oyster 5-15 parts, raw oyster 5-15 parts, bupleurum 8-12 parts, licorice 5-10 parts. The whole prescription takes blood-nourishing and liver-soothing as the treatment principle, and has the effects of regulating qi and soothing liver, and the patient's night rest condition can be improved.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating insomnia and its preparation method. Background Technology

[0002] Insomnia is a common disorder characterized by difficulty falling asleep, frequent awakenings, difficulty falling back asleep, and short sleep duration. Prolonged sleep deprivation can lead to increased anxiety and depression, and has a significant impact on the cardiovascular system. Severe sleep deprivation can also increase mortality rates. Studies show that insomnia is now the second leading cause of mental illness worldwide, with an incidence rate of 23-56%. 10% of people experience chronic insomnia, while nearly one-third have experienced transient insomnia. In my country, approximately 42.5% of the population suffers from insomnia to varying degrees, and this population is growing. Clinically, chronic insomnia severely impacts the work and daily life of patients, making improving sleep a critical issue worldwide. Current Western medicine treatments for insomnia often experience significant side effects, with many patients experiencing adverse reactions upon discontinuation. Therefore, the search for new and effective treatments is a primary concern. Traditional Chinese medicine, as an effective method for treating insomnia in clinical practice, plays a unique role in the treatment of insomnia due to its unique theoretical system. In recent years, the safety, stability, reliability, and convenience of traditional Chinese medicine in treating insomnia have gradually become apparent, gaining recognition and acceptance from the public.

[0003] CN116898923A discloses a traditional Chinese medicine formula for treating insomnia, composed of arborvitae seed, ginseng, jujube seed, poria cocos, poria cocos sclerotium, cinnamon, polygala tenuifolia, calamus, tortoise shell, dragon bone, coptis chinensis, rehmannia glutinosa, cinnabar, angelica sinensis, and licorice root. This pure Chinese herbal formula has the effects of calming the mind and soothing the nerves, nourishing and dispelling cold, thus fundamentally promoting sleep. Furthermore, this formula is based on traditional Chinese medicine diagnosis, with a scientifically reasonable proportion of ingredients, resulting in significant effects. It regulates yin and yang to nourish the patient, treating both deficiency and excess, effectively addressing both the symptoms and root cause of insomnia, and improving sleep quality.

[0004] CN108210712A discloses a traditional Chinese medicine composition for nourishing the heart and calming the mind, and its preparation method, comprising the following substances: stir-fried jujube seed, raw dragon bone, schisandra fruit, polygala root, red ginseng, poria cocos, raw rehmannia root, ophiopogon root, lily bulb, angelica root, longan pulp, white peony root, stir-fried tortoise shell, albizia bark, polygonum multiflorum stem, magnetite, acorus tatarinowii rhizome, arborvitae seed, licorice root, and amber. This traditional Chinese medicine composition for nourishing the heart and calming the mind has a good effect on neurasthenia, characterized by insomnia, forgetfulness, palpitations, memory loss, frequent dreams and easy awakening, and fatigue. It also has the beneficial effects of definite efficacy and few toxic side effects.

[0005] Currently, there are various traditional Chinese medicine (TCM) formulas used clinically to treat insomnia. However, many of these formulas are determined by physicians based solely on experience and have not been tested using pharmacodynamic models, leading to problems such as poor or unstable efficacy. Furthermore, traditional TCM treatments mainly rely on oral decoctions or compound preparations. While these can alleviate symptoms like insomnia, most have strong properties and flavors that can irritate the gastrointestinal tract, resulting in poor long-term treatment adherence and inconvenience in carrying them, making it difficult for patients to persist with long-term use. Therefore, there is an urgent need for a TCM composition that addresses both the symptoms and root cause, has stable efficacy, minimal side effects, and can effectively prevent or treat insomnia. Summary of the Invention

[0006] In view of the shortcomings of existing technologies, this invention provides a traditional Chinese medicine composition for treating insomnia and its preparation method through extensive experimental screening and clinical experience. It has few toxic side effects and a significant effect in treating insomnia.

[0007] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is as follows:

[0008] A traditional Chinese medicine composition for treating insomnia, by weight, is made from the following raw materials: 10-20 parts Angelica sinensis, 10-20 parts Rehmannia glutinosa, 5-15 parts Polygala tenuifolia, 10-20 parts Poria cocos, 5-15 parts Polygonum multiflorum, 6-12 parts Pinellia ternata, 6-12 parts Prunella vulgaris, 8-12 parts Tribulus terrestris, 5-15 parts raw Ostrea gigas, 5-15 parts raw Dragon bone, 8-12 parts Cynanchum paniculatum, and 5-10 parts Glycyrrhiza uralensis.

[0009] Preferably, the traditional Chinese medicine composition is made from the following raw materials: 12-18 parts of Angelica sinensis, 12-18 parts of Rehmannia glutinosa, 8-12 parts of Polygala tenuifolia, 12-18 parts of Poria cocos, 8-12 parts of Polygonum multiflorum, 8-10 parts of Pinellia ternata, 8-10 parts of Prunella vulgaris, 9-11 parts of Tribulus terrestris, 8-12 parts of raw Ostrea gigas, 8-12 parts of raw Dragon bone, 9-11 parts of Cynanchum paniculatum, and 7-9 parts of Glycyrrhiza uralensis.

[0010] Preferably, the traditional Chinese medicine composition is made from the following raw materials: 15 parts Angelica sinensis, 15 parts Rehmannia glutinosa, 10 parts Polygala tenuifolia, 15 parts Poria cocos, 10 parts Polygonum multiflorum, 9 parts Pinellia ternata, 9 parts Prunella vulgaris, 10 parts Tribulus terrestris, 10 parts raw oyster shell, 10 parts raw dragon bone, 10 parts Cynanchum paniculatum, and 8 parts Glycyrrhiza uralensis.

[0011] Furthermore, the present invention also provides a method for preparing the aforementioned traditional Chinese medicine composition, comprising the following steps:

[0012] (1) Weigh each Chinese herbal raw material according to the above weight ratio, clean them, and dry them at 30-40℃ for later use;

[0013] (2) Mix the dried Angelica sinensis, Rehmannia glutinosa, Polygala tenuifolia, Poria cocos, Polygonum multiflorum and Glycyrrhiza uralensis evenly, grind and pulverize them, and pass them through an 80-120 mesh sieve to obtain medicinal powder.

[0014] (3) Mix the dried Pinellia ternata, Prunella vulgaris, raw dragon bone, raw oyster shell, Cynanchum paniculatum and Tribulus terrestris evenly, add 5-10 times the weight of the raw materials in distilled water, decoct 2-3 times, combine the filtrates and concentrate under reduced pressure to obtain an extract, dry the extract at 30-40℃, grind and pulverize it and pass it through an 80-120 mesh sieve to obtain the second medicinal powder.

[0015] (4) Mix and stir the first powder, the second powder, the binder and distilled water, knead and form into pills, package and store.

[0016] Preferably, the extraction time for each decoction is 2-3 hours.

[0017] Preferably, the extract has a relative density of 1.1-1.2 when the filtrate is concentrated under reduced pressure to 75°C.

[0018] Preferably, the adhesive is selected from honey, rice paste, or flour paste.

[0019] Furthermore, the present invention also provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicament for treating insomnia.

[0020] Properties of various Chinese medicinal materials:

[0021] Angelica sinensis: enters the liver, heart, and spleen meridians; nourishes blood, invigorates blood circulation, regulates menstruation, relieves pain, moistens dryness and lubricates the intestines; mainly treats various symptoms of blood deficiency, irregular menstruation, amenorrhea, dysmenorrhea, etc.

[0022] Rehmannia glutinosa: Enters the heart, liver, and kidney meridians; nourishes yin and clears heat, cools blood and replenishes blood; mainly treats feverish thirst, internal heat and thirst, metrorrhagia, hematuria, hematochezia, blood deficiency and chlorosis, dizziness and palpitations; blood deficiency and amenorrhea, etc.

[0023] Polygala tenuifolia: It enters the heart, liver, spleen, and kidney meridians; it calms the mind and soothes the nerves, eliminates phlegm and opens the orifices, detoxifies and reduces swelling; it is mainly used to treat restlessness, palpitations, insomnia, forgetfulness, epilepsy, cough with excessive phlegm, etc.

[0024] Poria cocos: Enters the heart and spleen meridians; calms the mind, soothes the nerves, and promotes urination; treats palpitations, forgetfulness, insomnia due to forgetfulness, epilepsy, and difficulty urinating.

[0025] Polygonum multiflorum: Enters the heart and liver meridians; nourishes the heart and calms the mind, dispels wind, and unblocks the meridians; mainly treats insomnia, excessive dreaming, blood deficiency and body pain, numbness of the skin, rheumatic pain, and itchy rashes.

[0026] Pinellia ternata: It enters the spleen, stomach, and lung meridians; it dries dampness and resolves phlegm, relieves nausea and vomiting, and dissipates lumps and nodules; it is mainly used to treat cough and asthma with excessive phlegm, vomiting and nausea, chest and epigastric fullness, headache and dizziness, and restlessness at night.

[0027] Prunella vulgaris: Enters the liver and gallbladder meridians; clears liver heat and improves eyesight, disperses nodules and detoxifies; mainly treats eye pain, headache and dizziness, tinnitus, acute and chronic hepatitis, hypertension, etc.

[0028] Tribulus terrestris: enters the liver, lung, kidney, and heart meridians; soothes the liver, relieves depression, dispels wind and improves eyesight; treats headache, dizziness, chest and rib pain, breast pain, blocked milk ducts, amenorrhea, etc.

[0029] Raw oyster: enters the liver and kidney meridians; calms the liver and subdues yang, soothes the mind and spirit, softens hardness and dissipates nodules, astringes and consolidates; mainly treats dizziness, tinnitus, palpitations, insomnia, spontaneous sweating and night sweats, etc.

[0030] Raw dragon bone: It enters the heart, liver, kidney, and large intestine meridians; it calms the nerves and soothes the mind, calms the liver and subdues yang, consolidates and astringes; it is mainly used to treat epilepsy, mania, palpitations, insomnia, forgetfulness, dizziness, spontaneous sweating, and night sweats.

[0031] Baiwei (Radix Cynanchi Atrati): Enters the lung, stomach, and liver meridians; clears heat and nourishes yin, promotes urination and relieves strangury, detoxifies and heals sores; mainly treats febrile diseases, fever with rashes, tidal fever with bone steaming, lung heat cough, postpartum weakness and irritability, hot strangury, hematuria, sore throat, etc.

[0032] Licorice: It enters the spleen, stomach, heart, and lung meridians; it invigorates qi and nourishes the middle jiao, relieves spasms and pain, moistens the lungs and stops cough, clears heat and detoxifies, and harmonizes other medicines; it is mainly used to treat fatigue, poor appetite, emaciation and sallow complexion, palpitations and shortness of breath, abdominal pain and loose stools, spasms and pain in the limbs, cough and wheezing, sore throat, etc.

[0033] Compared with the prior art, the beneficial effects of the present invention are: the traditional Chinese medicine composition is based on the theory of syndrome differentiation and treatment in traditional Chinese medicine, with the principles of nourishing blood and calming the mind, soothing the liver and relieving depression, and is rationally formulated and matched, resulting in a significant effect in treating insomnia. In this formula: Angelica sinensis is the chief herb, directly nourishing the liver to achieve the effects of replenishing blood and calming the mind; Rehmannia glutinosa is the assistant herb, nourishing yin, clearing heat, cooling blood, and replenishing blood. Together with Angelica sinensis, it clears heat from the triple burner and also cools blood and relieves irritability; Polygala tenuifolia, Poria cocos, Polygonum multiflorum, Pinellia ternata, Prunella vulgaris, raw dragon bone, raw oyster shell, Cynanchum paniculatum, and Tribulus terrestris are the adjuvant herbs. Polygala tenuifolia calms the mind, Poria cocos is calming and soothing, Polygonum multiflorum is calming and relieving depression, Pinellia ternata and Prunella vulgaris are used together to relieve fullness in the chest and hypochondrium, raw dragon bone and raw oyster shell are used together to calm the mind and soothe the mind and suppress liver yang, Cynanchum paniculatum is used together with Tribulus terrestris to achieve the effects of clearing heat, calming the liver, and cooling blood; Glycyrrhiza uralensis is the guiding herb, nourishing heart qi and harmonizing the effects of the other herbs. The whole formula takes nourishing blood and calming the mind, soothing the liver and relieving depression as the treatment principle, and works together to regulate qi and calm the mind, relieve depression and promote sleep, soothe the stagnant liver wood, regulate emotions, and fully improve the patient's sleep at night. Detailed Implementation

[0034] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Unless otherwise specified, the materials and reagents used are commercially available.

[0035] Example 1: A traditional Chinese medicine composition for treating insomnia

[0036] Prescription dosage: Angelica sinensis 15g, Rehmannia glutinosa 15g, Polygala tenuifolia 10g, Poria cocos 15g, Polygonum multiflorum 10g, Pinellia ternata 9g, Prunella vulgaris 9g, Tribulus terrestris 10g, Ostrea gigas 10g, Os draconis 10g, Cynanchum paniculatum 10g, Glycyrrhiza uralensis 8g.

[0037] The preparation method of the traditional Chinese medicine composition includes the following steps:

[0038] (1) Weigh each Chinese herbal raw material according to the above weight ratio, clean them, and dry them at 35℃ for later use;

[0039] (2) Mix the dried Angelica sinensis, Rehmannia glutinosa, Polygala tenuifolia, Poria cocos, Polygonum multiflorum and Glycyrrhiza uralensis evenly, grind and pulverize them and pass them through a 100-mesh sieve to obtain medicinal powder one;

[0040] (3) Mix the dried Pinellia ternata, Prunella vulgaris, raw dragon bone, raw oyster shell, Cynanchum paniculatum and Tribulus terrestris evenly, add 8 times the weight of the raw materials of distilled water, decoct 3 times, and each decoction takes 2 hours to extract. Combine the filtrates and concentrate under reduced pressure to an extract with a relative density of 1.1 at 75°C. Dry the extract at 35°C, grind and pulverize it and pass it through a 100-mesh sieve to obtain the second medicinal powder.

[0041] (4) Mix and stir the first powder, the second powder, honey and distilled water, knead and make into pills, package and store.

[0042] Example 2: A traditional Chinese medicine composition for treating insomnia

[0043] Prescription dosage: Angelica sinensis 18g, Rehmannia glutinosa 18g, Polygala tenuifolia 8g, Poria cocos 18g, Polygonum multiflorum 8g, Pinellia ternata 10g, Prunella vulgaris 10g, Tribulus terrestris 9g, Ostrea gigas 12g, Os draconis 12g, Cynanchum paniculatum 9g, Glycyrrhiza uralensis 7g.

[0044] The preparation method of the traditional Chinese medicine composition is the same as in Example 1.

[0045] Example 3: A traditional Chinese medicine composition for treating insomnia

[0046] Prescription dosage: Angelica sinensis 12g, Rehmannia glutinosa 12g, Polygala tenuifolia 12g, Poria cocos 12g, Polygonum multiflorum 12g, Pinellia ternata 8g, Prunella vulgaris 8g, Tribulus terrestris 11g, Ostrea gigas 8g, Os draconis 8g, Cynanchum paniculatum 11g, Glycyrrhiza uralensis 9g.

[0047] The preparation method of the traditional Chinese medicine composition is the same as in Example 1.

[0048] Comparative Example 1 (using white peony root and chuanxiong rhizome instead of angelica root and rehmannia root in Example 1)

[0049] Prescription dosage: White peony root 15g, Sichuan lovage rhizome 15g, Polygala root 10g, Poria cocos 15g, Polygonum multiflorum stem 10g, Pinellia ternata 9g, Prunella vulgaris 9g, Tribulus terrestris 10g, raw oyster shell 10g, raw dragon bone 10g, Cynanchum paniculatum 10g, licorice root 8g.

[0050] The preparation method of the traditional Chinese medicine composition is the same as in Example 1.

[0051] Comparative Example 2 (using turmeric and jujube seed instead of polygala and poria in Example 1)

[0052] Prescription dosage: Angelica sinensis 15g, Rehmannia glutinosa 15g, Curcuma longa 10g, Ziziphus jujuba var. spinosa 15g, Polygonum multiflorum 10g, Pinellia ternata 9g, Prunella vulgaris 9g, Tribulus terrestris 10g, Ostrea gigas 10g, Os draconis 10g, Cynanchum paniculatum 10g, Glycyrrhiza uralensis 8g.

[0053] The preparation method of the traditional Chinese medicine composition is the same as in Example 1.

[0054] Comparative Example 3 (using stir-fried bitter orange peel and mimosa flower instead of raw oyster and raw pork bone in Example 1)

[0055] Prescription dosage: Angelica sinensis 15g, Rehmannia glutinosa 15g, Polygala tenuifolia 10g, Poria cocos 15g, Polygonum multiflorum 10g, Pinellia ternata 9g, Prunella vulgaris 9g, Tribulus terrestris 10g, Citrus aurantium 10g, Albizia julibrissin 10g, Cynanchum paniculatum 10g, Glycyrrhiza uralensis 8g.

[0056] The preparation method of the traditional Chinese medicine composition is the same as in Example 1.

[0057] Comparative Example 4 (using Gentiana scabra and Bupleurum chinense instead of Tribulus terrestris and Cynanchum paniculatum in Example 1)

[0058] Prescription dosage: Angelica sinensis 15g, Rehmannia glutinosa 15g, Polygala tenuifolia 10g, Poria cocos 15g, Polygonum multiflorum 10g, Pinellia ternata 9g, Prunella vulgaris 9g, Gentiana scabra 10g, Ostrea gigas 10g, Os draconis 10g, Bupleurum chinense 10g, Glycyrrhiza uralensis 8g.

[0059] The preparation method of the traditional Chinese medicine composition is the same as in Example 1.

[0060] Clinical trial studies

[0061] 1. Case source: This study included 120 patients with insomnia, all of whom visited the outpatient department of the China Academy of Chinese Medical Sciences between January and December 2023.

[0062] 2. Diagnostic criteria:

[0063] Traditional Chinese Medicine (TCM) diagnostic criteria: Based on the criteria in the "Guidelines for Diagnosis and Treatment of Common Diseases in TCM Internal Medicine (TCM Diseases Section)" published by China Press of Traditional Chinese Medicine, the main symptoms are: difficulty falling asleep, easy to wake up after falling asleep, chest and rib distension, irritability and easy to be startled, depression and tension. The diagnosis can be made by combining these symptoms with a pale red tongue, white coating and wiry pulse.

[0064] Western medicine diagnostic criteria: Refer to the diagnostic criteria for insomnia in the "Chinese Classification and Diagnostic Criteria for Mental Disorders, Third Edition": (1) Having typical insomnia symptoms; (2) Insomnia ≥ 3 times per week, with a course of illness ≥ 1 month; (3) Having insomnia and a dominant belief that they are extremely concerned about the outcome of insomnia; (4) Excluding secondary insomnia caused by mental disorders and organic diseases.

[0065] 3. Inclusion criteria: (1) Meets the above-mentioned Western and Chinese medicine diagnostic criteria; (2) Has not taken sedative-hypnotic drugs regularly or addically within 1 month; (3) Is mentally clear and can answer questions and fill out forms clearly; (4) Voluntarily join this clinical trial and sign informed consent form.

[0066] 4. Grouping and Experimental Methods:

[0067] Western medicine control group (20 patients): Administered eszopiclone (Qilu Pharmaceutical Co., Ltd., approval number: National Drug Approval Number H20213536), 3.0 mg / tablet, one tablet taken half an hour before bedtime each night.

[0068] The traditional Chinese medicine group (100 patients, randomly divided into 5 groups): The patients were given the traditional Chinese medicine pills of Example 1 and Comparative Examples 1-4, respectively, and were taken 3 times a day (one hour after breakfast, one hour after lunch, and half an hour before bedtime), with 2 pills each time.

[0069] The treatment course was 4 weeks, with weekly follow-up visits. PSQI assessment and TCM symptom scoring were conducted before and after treatment.

[0070] 5. Observation indicators:

[0071] The Pittsburgh Sleep Quality Index (PSQI) is a self-reported sleep quality scale that assesses sleep quality across seven areas: recent sleep onset time, sleep duration, sleep disturbances, sleep quality, sleep efficiency, daytime dysfunction, and medication use. As the world's most widely recognized sleep quality assessment scale, each section is scored from 0 to 3, divided into four levels (PSQI grading standards: Normal ≤ 5, 6 ≤ Mild ≤ 10, 11 ≤ Moderate ≤ 15, 16 ≤ Severe ≤ 21). This study excluded patients who were self-medicating, therefore a total of six sections were included, with total scores ranging from 0 to 18. Scores were negatively correlated with sleep quality.

[0072] Traditional Chinese Medicine Symptom Scoring: The TCM symptom scoring was conducted in accordance with the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs". It mainly examined six symptoms, including "difficulty falling asleep, easy to wake up after falling asleep, chest and rib distension, irritability and easy to be startled, depression and tension". The above symptoms were scored in four stages: none (0 points), mild (occasionally occurring: 1 point), moderate (occasionally occurring: 2 points), and severe (frequently occurring: 3 points), with a total score of 18 points.

[0073] 6. Treatment results:

[0074] (1) The comparison of PSQI scores of patients in each group before and after treatment is shown in Table 1.

[0075] Table 1 Comparison of PSQI scores among different groups of patients

[0076]

[0077]

[0078] (2) The comparison of TCM symptom scores of patients in each group before and after treatment is shown in Table 2.

[0079] Table 2 Comparison of TCM symptom scores among different groups of patients

[0080]

[0081] (3) Results Analysis

[0082] As shown in Tables 1-2, after 4 weeks of treatment, the insomnia patients taking the herbal pills of Example 1 of this invention showed significant decreases in both PSQI scores and TCM symptom scores, approaching the scores of the positive control group—the eszopiclone administration group. This indicates that the herbal composition of this invention can significantly improve the nighttime rest of insomnia patients. Specifically, the PSQI and TCM symptom scores show that the herbal composition of this invention is effective in improving PSQI indicators such as sleep onset time, sleep duration, sleep disturbances, sleep quality, sleep efficiency, and daytime dysfunction in insomnia patients, as well as TCM symptoms such as difficulty falling asleep, frequent awakenings, chest and rib distension, irritability, depression, and emotional tension. It can effectively alleviate patients' depression and anxiety, and improve their quality of life. Furthermore, this invention also conducted a herbal substitution experiment (Comparative Examples 1-4). The results showed that when using white peony root and chuanxiong rhizome instead of angelica root and rehmannia root, turmeric and jujube seed instead of polygala root and poria cocos, fried immature bitter orange peel and albizia flower instead of raw oyster shell and raw dragon bone, and gentian root and bupleurum root instead of tribulus terrestris and cynanchum atratum, the resulting herbal compositions were all less effective in treating insomnia than the herbal composition of this invention. This further confirms that the herbal composition of this invention is based on the theory of syndrome differentiation and treatment in traditional Chinese medicine, with the principles of nourishing blood and calming the mind, and soothing the liver and relieving depression. Through reasonable formulation and compatibility, it can significantly improve patients' nighttime rest. After follow-up observation, the patients' sleep conditions remained stable after the treatment ended, indicating that the formulation has a definite and stable therapeutic effect and can be further promoted and applied in clinical practice.

[0083] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several modifications or equivalent substitutions can be made to the technical solution without departing from the principle of the present invention, and these modifications or equivalent substitutions should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating insomnia, characterized in that: The traditional Chinese medicine composition, by weight, is made from the following raw materials: 10-20 parts Angelica sinensis, 10-20 parts Rehmannia glutinosa, 5-15 parts Polygala tenuifolia, 10-20 parts Poria cocos, 5-15 parts Polygonum multiflorum, 6-12 parts Pinellia ternata, 6-12 parts Prunella vulgaris, 8-12 parts Tribulus terrestris, 5-15 parts raw Ostrea gigas, 5-15 parts raw Dragon bone, 8-12 parts Cynanchum paniculatum, and 5-10 parts Glycyrrhiza uralensis.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition, by weight, is made from the following raw materials: Angelica sinensis 12-18 parts, Rehmannia glutinosa 12-18 parts, Polygala tenuifolia 8-12 parts, Poria cocos 12-18 parts, Polygonum multiflorum 8-12 parts, Pinellia ternata 8-10 parts, Prunella vulgaris 8-10 parts, Tribulus terrestris 9-11 parts, Ostrea gigas 8-12 parts, Os draconis 8-12 parts, Cynanchum paniculatum 9-11 parts, Glycyrrhiza uralensis 7-9 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that: The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 15 parts Angelica sinensis, 15 parts Rehmannia glutinosa, 10 parts Polygala tenuifolia, 15 parts Poria cocos, 10 parts Polygonum multiflorum, 9 parts Pinellia ternata, 9 parts Prunella vulgaris, 10 parts Tribulus terrestris, 10 parts raw Ostrea gigas, 10 parts raw Dragon bone, 10 parts Cynanchum paniculatum, and 8 parts Glycyrrhiza uralensis.

4. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, Includes the following steps: (1) Weigh each Chinese herbal raw material according to the above weight ratio, clean them, and dry them at 30-40℃ for later use; (2) Mix the dried Angelica sinensis, Rehmannia glutinosa, Polygala tenuifolia, Poria cocos, Polygonum multiflorum and Glycyrrhiza uralensis evenly, grind and pulverize them, and pass them through an 80-120 mesh sieve to obtain medicinal powder. (3) Mix the dried Pinellia ternata, Prunella vulgaris, raw dragon bone, raw oyster shell, Cynanchum paniculatum and Tribulus terrestris evenly, add 5-10 times the weight of the raw materials in distilled water, decoct 2-3 times, combine the filtrates and concentrate under reduced pressure to obtain an extract, dry the extract at 30-40℃, grind and pulverize it and pass it through an 80-120 mesh sieve to obtain the second medicinal powder. (4) Mix and stir the first powder, the second powder, the binder and distilled water, knead and form into pills, package and store.

5. The preparation method according to claim 4, characterized in that, The extraction time for each decoction is 2-3 hours.

6. The preparation method according to claim 4, characterized in that, The filtrate is concentrated under reduced pressure to obtain an extract with a relative density of 1.1-1.2 at 75°C.

7. The preparation method according to claim 4, characterized in that, The adhesive is selected from honey, rice paste, or flour paste.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-3 or the traditional Chinese medicine composition prepared by the preparation method according to any one of claims 4-7 in the preparation of a drug for treating insomnia.

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