Traditional Chinese medicine composition with effects of soothing nerves and helping sleep as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the field of biological medicine, and particularly relates to a traditional Chinese medicine composition with nerve soothing and sleep aiding effects, a preparation method and application, the composition is prepared by compounding spina date seed, platycladi seed, astragalus membranaceus, longan aril, medlar, dogwood, tuber fleeceflower stem, bighead atractylodes rhizome, angelica sinensis, poria cocos, polygala tenuifolia, ginseng, lily, elecampane, pericarpium citri reticulatae, liquorice, wheat and gamma-aminobutyric acid. The preparation method comprises the following steps: S1, drying and crushing semen ziziphi spinosae, semen boitae, rhizoma atractylodis macrocephalae, radix angelicae sinensis, radix aucklandiae and pericarpium citri reticulatae, and performing supercritical carbon dioxide extraction to obtain a raw material volatile oil A; s2, crushing astragalus membranaceus, longan aril, wolfberry, dogwood, tuber fleeceflower stem, poria cocos, polygala tenuifolia, ginseng, lily, liquorice and wheat, mixing the crushed materials with medicine residues obtained after the volatile oil is extracted in the step S1, and performing extraction, concentration and drying to obtain raw material powder B; s3, clathrating the volatile oil A obtained in the step S1 with hydroxypropyl beta cyclodextrin, and drying to obtain raw material powder C; s4, mixing the raw material powder B, the raw material powder C and gamma-aminobutyric acid to obtain the traditional Chinese medicine composition. The composition and the preparation thereof can improve the symptoms of lassitude, impatient temperament and irritability caused by difficulty in falling asleep, dreaminess, easy waking and insufficient sleep of an insomnia patient, and can deepen the sleep depth of the patient and prolong the sleep duration.

Description

TECHNICAL FIELD

[0001] The present application belongs to the field of biological medicine, and particularly relates to a traditional Chinese medicine composition with the effects of soothing the nerves and helping sleep, a preparation method and application. BACKGROUND

[0002] With the increasingly fierce social competition, the pace of people's work and life is accelerating, leading to an increasing problem of sleep affected by stress. Poor sleep quality or even insomnia directly affects the next day's study, work and life.

[0003] Insomnia is also called "not sleeping" in traditional Chinese medicine, and the causes and mechanisms are mainly due to heart and spleen deficiency and heart-kidney disharmony. Insomnia mainly manifests in three aspects: difficulty falling asleep at night, decreased sleep quality and reduced sleep time, leading to daytime drowsiness, decreased memory and attention, and easy occurrence of daytime sleepiness. Long-term sleep deprivation or partial deprivation can easily produce "microsleep" state (Terry Cralle W. David Brown: "Unscientific Science - Alternative Research on Human Sleep"), that is, a short sleep of several tenths of a second to half a minute, during which the brain automatically shuts down, consciousness is lost, and the person is completely cut off from the outside world, which is extremely dangerous when driving. Long-term insomnia will have a great harm to people's spirit and body. A series of physical discomforts caused by insomnia have a great harm to human body function, intelligence and immunity. For adolescents and children, insomnia will affect their growth and development and intelligence growth (Kang Xuli, Adolescent Sleep Disorders Cannot Be Ignored, Youth Health, 2023, 10, 14-15.); for adults, long-term insomnia will affect people's thinking activities, damage people's immune system, and even lead to depression (Li Guojun, Wang Genwei, Hao Zhuoqun, et al. Mediating Role of Inflammatory Factors between Insomnia Symptoms and Cognitive Function in Patients with Major Depressive Disorder, Neurological Diseases and Mental Health, 2025, 25(08), 555-560).

[0004] At present, insomnia is mainly treated by chemical drugs, mainly some tranquilizers (benzodiazepine drugs). The disadvantage of such drugs is that they have a large side effect, mainly manifested as dizziness, muscle weakness, similar to "hangover state" in the morning, easy distraction of attention during the day, and low work efficiency. In addition, there are adverse reactions such as addiction and rebound insomnia. Long-term and large-scale use produces dependence, and once the drug is stopped, the original symptoms such as insomnia and restlessness will reappear, and there will also be various physical symptoms such as palpitation, nausea, sweating, etc., which seriously affect the normal work, study and life of patients.

[0005] Some traditional Chinese medicines have sleep-aiding effects, with jujube seed being a representative example. Known as the "Oriental Sleeping Fruit," it is a food-medicine homology herb that has gained widespread attention due to its relatively high safety profile. Chinese patent ZL201510042001.7 discloses a method for preparing jujube seed extract and a brain-boosting and sleep-aiding oral liquid containing jujube seed extract. The preparation process involves grinding jujube seeds into powder and then extracting the extract using water, acid-water, and alkaline water methods. Chinese patent ZL202010792346.5 discloses a formula primarily composed of jujube seed, combined with polygonatum, alpinia oxyphylla, wolfberry, lily bulb, and poria cocos. Total saponins from jujube seed are extracted using 80% ethanol, resulting in a functional food product with sleep-improving effects. Similar formulas exist, indicating that traditional Chinese medicine does have therapeutic effects on sleep. However, these products all neglect the role of jujube seed oil in their jujube seed preparation processes. Pharmacological studies have shown that jujube seed oil has a direct hypnotic effect on mice, and no tolerance was observed with long-term use (Wu Shanglin, Yuan Bingxiang, Ma Zhiyi, Effects of long-term use of jujube seed oil on the hypnotic effect in mice, Northwest Pharmaceutical Journal, 2001, 16(3), 114-115). In processing and clinical practice, it has also been found that "if jujube seed is fried for too long, the oil will become dry and lose its aroma, and it will be difficult to see its effects," because jujube seed oil has a variety of pharmacological activities such as sedation, antidepressant, and antioxidant. Therefore, jujube seed is best used raw (Zhao Kai, Wang Yifei, Li Xin, et al., Progress in the research and application of jujube seed oil, China Cereals and Oils Journal, 2022, 37(12), 311-320.).

[0006] Therefore, considering the various shortcomings of existing technologies, it is necessary to provide a new solution to insomnia by combining traditional Chinese medicine theory with modern advanced technology. Summary of the Invention

[0007] To address the problems mentioned in the background art, this invention proposes a traditional Chinese medicine composition with calming and sleep-aiding effects. It can improve symptoms of insomnia patients such as difficulty falling asleep, frequent dreams and easy awakening, and lethargy and irritability caused by insufficient sleep. It can also deepen the patient's sleep, prolong sleep duration, and enable insomnia patients to maintain a good mental state after waking up.

[0008] The technical solution adopted by the present invention to solve its technical problem is: to provide a traditional Chinese medicine composition with the effect of calming the nerves and aiding sleep, comprising: jujube seed, cypress seed, astragalus, longan pulp, wolfberry, cornus officinalis, polygonum multiflorum, atractylodes macrocephala, angelica sinensis, poria cocos, polygala tenuifolia, ginseng, lily bulb, costus root, tangerine peel, licorice, wheat, and γ-aminobutyric acid.

[0009] Further, the mass parts of each raw material are as follows: Zizyphus jujuba 1-50 parts, Platycladus orientalis 1-50 parts, Astragalus membranaceus 1-50 parts, Longan 1-50 parts, Lycium barbarum 1-50 parts, Cornus officinalis 1-50 parts, Cuscuta japonica 1-20 parts, Atractylodes macrocephala 1-30 parts, Angelica sinensis 1-10 parts, Poria cocos 1-50 parts, Polygala 1-50 parts, Panax ginseng 1-20 parts, Lilium brownii 1-30 parts, Saussurea lappa 1-10 parts, Citrus reticulata 1-10 parts, Glycyrrhiza uralensis 1-10 parts, Triticum aestivum 1-20 parts, and gamma-aminobutyric acid 1-10 parts.

[0010] Preferably, the traditional Chinese medicine composition of the present application is prepared from the following mass parts of traditional Chinese medicine raw materials: Zizyphus jujuba 20-50 parts, Platycladus orientalis 20-50 parts, Astragalus membranaceus 20-50 parts, Longan 20-50 parts, Lycium barbarum 20-50 parts, Cornus officinalis 20-50 parts, Cuscuta japonica 5-20 parts, Atractylodes macrocephala 5-30 parts, Angelica sinensis 2-10 parts, Poria cocos 20-50 parts, Polygala 20-50 parts, Panax ginseng 2-20 parts, Lilium brownii 3-30 parts, Saussurea lappa 2-10 parts, Citrus reticulata 2-10 parts, Glycyrrhiza uralensis 2-10 parts, Triticum aestivum 2-20 parts, and gamma-aminobutyric acid 2-10 parts.

[0011] More preferably, the traditional Chinese medicine composition of the present application is prepared from the following mass parts of traditional Chinese medicine raw materials: Zizyphus jujuba 30-45 parts, Platycladus orientalis 30-45 parts, Astragalus membranaceus 30-45 parts, Longan 30-45 parts, Lycium barbarum 30-45 parts, Cornus officinalis 30-45 parts, Cuscuta japonica 10-15 parts, Atractylodes macrocephala 10-20 parts, Angelica sinensis 4-8 parts, Poria cocos 30-45 parts, Polygala 30-45 parts, Panax ginseng 5-15 parts, Lilium brownii 5-15 parts, Saussurea lappa 3-6 parts, Citrus reticulata 3-6 parts, Glycyrrhiza uralensis 4-8 parts, Triticum aestivum 4-10 parts, and gamma-aminobutyric acid 3-6 parts.

[0012] Further, the dosage form of the traditional Chinese medicine composition includes solid beverage, oral liquid, tablet, capsule, granule, pill or paste.

[0013] The principle of the composition of the 18 raw materials contained in the present application is as follows:

[0014] The present application adopts Zizyphus jujuba, Platycladus orientalis, Astragalus membranaceus and Longan as monarch drugs, which have the effects of nourishing heart and calming spirit, and tonifying qi and blood; Lycium barbarum, Cornus officinalis, Cuscuta japonica, Atractylodes macrocephala, Angelica sinensis, Poria cocos, Polygala, Panax ginseng and Lilium brownii are minister drugs, which have the effects of tonifying kidney yin, calming heart and blood, and tonifying qi and spleen; Saussurea lappa, Citrus reticulata, Glycyrrhiza uralensis and Triticum aestivum are auxiliary drugs, which have the effects of regulating qi, relieving middle, resolving accumulation and harmonizing stomach. The above-mentioned prescription has the effects of tonifying spleen and qi, calming heart and moistening kidney, and is suitable for treating palpitation, insomnia, dreaminess, forgetfulness, dizziness and tinnitus caused by heart-spleen deficiency and heart-kidney disharmony. In addition, gamma-aminobutyric acid, a central inhibitory neurotransmitter, has good effects on various insomnia.

[0015] The properties, tastes, meridians and functions of the traditional Chinese medicine raw materials used in the present application are as follows:

[0016] Semen Ziziphi Spinosae: neutral in nature, sweet and sour in taste, and meridian entry into the liver, gallbladder and heart. It has the effects of nourishing the heart and liver, calming the nerves, and stopping sweating. It is mainly used for blood deficiency palpitation, physical weakness and excessive sweating, restlessness, forgetfulness, insomnia and dreaminess, etc.

[0017] Semen Platycladi: neutral in nature, sweet in taste, and meridian entry into the heart, kidney and large intestine. It has the effects of nourishing the heart, calming the nerves, moistening the intestines, and stopping sweating. It is used for treating yin blood deficiency, insomnia, heart palpitations, dry intestines and constipation, and yin deficiency sweating, etc.

[0018] Radix Astragali: slightly warm in nature, sweet in taste, and meridian entry into the lung and spleen. It has the effects of tonifying qi, ascending yang, stopping sweating, promoting water and reducing swelling, producing saliva and nourishing blood, and removing stagnation and relieving pain. It is used for treating spleen and lung qi deficiency, qi deficiency and blood stasis, etc.

[0019] Arillus Longan: neutral in nature, sweet in taste, and meridian entry into the heart, liver, spleen and kidney. It has the effects of tonifying blood, calming the nerves, invigorating the brain and intelligence, and nourishing the heart and spleen. It is used for treating physical weakness, heart palpitations, insomnia, forgetfulness, diarrhea, postpartum edema, mental fatigue, and sweating, etc.

[0020] Fructus Lycii: neutral in nature, sweet in taste, and meridian entry into the liver, heart and spleen. It has the effects of nourishing the liver and kidney, and benefiting the eyesight. It is used for treating dizziness and blurred vision caused by liver and kidney deficiency, and softness of the waist and knees, spermatorrhea, and diabetes caused by yin deficiency, etc.

[0021] Fructus Corni: slightly warm in nature, sour and astringent in taste, and meridian entry into the liver and kidney. It has the effects of tonifying the liver and kidney, and astringing essence and preventing leakage. It is used for treating dizziness, tinnitus, soreness of the waist and knees, impotence and spermatorrhea, frequent urination, leucorrhea, profuse sweating, and diabetes, etc.

[0022] Caulis Polygoni Multiflori: neutral in nature, sweet and slightly bitter in taste, and meridian entry into the heart and liver. It has the effects of nourishing the heart and calming the nerves, dispelling wind and dredging collaterals, and dispelling wind and relieving itching. It is used for treating insomnia, dreaminess, blood deficiency and body pain, wind rashes, and skin itching, etc.

[0023] Rhizoma Atractylodis Macrocephalae: warm in nature, bitter and sweet in taste, and meridian entry into the spleen and stomach. It has the effects of tonifying qi, invigorating the spleen, drying dampness, promoting urination, stopping sweating, and preventing miscarriage, etc. It is used for treating spleen and stomach qi deficiency, spleen deficiency diarrhea, and edema, etc.

[0024] Radix Angelicae Sinensis: pungent and slightly warm in nature, sweet in taste, and meridian entry into the liver, heart and spleen. It has the effects of tonifying blood, regulating menstruation and relieving pain, and moistening the intestines and promoting defecation. It is used for treating blood deficiency, dizziness, palpitations, irregular menstruation, amenorrhea and dysmenorrhea, cold and damp arthralgia, contusions and sprains, dry intestines and constipation, etc.

[0025] Poria: nature is flat, sweet and light, and belongs to the heart, lung, spleen and kidney. It has the effect of promoting water and removing dampness, strengthening the spleen, calming the heart and soothing the nerves. It is often used in the treatment of difficult urination, edema, vomiting, spleen and stomach weakness, and other symptoms such as reduced diet, palpitation, insomnia, forgetfulness, and impotence.

[0026] Jujube: warm, bitter and bitter, and belongs to the heart, kidney and lung. It has the effect of soothing the heart and kidney, removing phlegm and opening the mind, and dispelling carbuncles. It is often used to treat insomnia, palpitation, forgetfulness, and other symptoms caused by heart-kidney disharmony, phlegm obstruction, and sore pain.

[0027] Ginseng: warm, sweet and bitter, and belongs to the spleen, lung and heart. Ginseng has the effect of replenishing vital energy, restoring pulse, strengthening the spleen and lung, producing saliva and blood, and soothing the nerves. It is mainly used to treat body weakness, lung cough, impotence, internal heat, and other symptoms such as prolonged illness, palpitation, insomnia, and forgetfulness.

[0028] Lily: slightly cold, sweet, and belongs to the heart and lung. It has the effect of nourishing yin and moistening the lungs, and calming the heart and soothing the nerves. It is suitable for treating dry cough, labor cough, blood cough, and other symptoms such as insomnia, dreaminess, and mental confusion.

[0029] Saussurea: warm, bitter and bitter, and belongs to the spleen, large intestine and triple energizer. It has the effect of promoting qi, strengthening the spleen, digesting food and relieving pain, and is mainly used to treat chest and stomach pain, and other symptoms such as indigestion and loss of appetite caused by spleen and stomach weakness.

[0030] Dried tangerine peel: warm, bitter and bitter, and belongs to the spleen, stomach and lung. It has the effect of regulating qi and digestion, drying dampness and phlegm, and promoting water and relieving constipation. It is used to treat abdominal distension, food and water, and other symptoms such as wet phlegm, cold phlegm, and cough caused by spleen and stomach qi stagnation.

[0031] Gancao: nature is flat, sweet, and belongs to the heart, lung, spleen and stomach. It has the effect of benefiting qi, tonifying the center, moistening the lungs, relieving cough, clearing heat and detoxifying, relieving pain, and regulating the properties of drugs. It is often used in combination with other drugs.

[0032] Wheat: cool, sweet, and belongs to the heart, spleen and kidney. It has the effect of nourishing the heart and spleen, relieving thirst, clearing heat and diuresis. It can be used to regulate the heart and mind, insomnia, and other symptoms such as body restlessness, mental depression, and mental depression.

[0033] For the combination of the above monarch, minister, and assistant drugs, the present application also provides a preparation method of a traditional Chinese medicine composition with the effects of soothing the nerves and helping sleep, comprising the following steps:

[0034] S1, dry and crush Jujube, Platycladus orientalis seed, Atractylodes, Angelica, Saussurea, and dried tangerine peel, and then extract them by supercritical carbon dioxide to obtain raw material volatile oil A;

[0035] S2, the astragalus, longan meat, medlar, dogwood, moonlight vine, tuckahoe, polygala, ginseng, lily, licorice, wheat are crushed, and the residue after extracting the volatile oil in S1 is combined, extracted, concentrated, and dried to obtain raw powder B;

[0036] S3, the volatile oil A obtained in S1 is complexed with HP-β-CD, and after drying, raw powder C is obtained; HP-β-CD is hydroxypropyl β cyclodextrin;

[0037] S4, the raw powder B, the raw powder C and the gamma-aminobutyric acid are mixed to obtain a traditional Chinese medicine composition.

[0038] Research shows that in some embodiments, this part of raw powder C is combined with other extracts for use, which has better synergistic effect. In some embodiments, a part of the medicinal materials in the above formula is selected and prepared into a product according to the principle of monarch, minister, assistant and guide, which also has a certain effect of soothing the nerves and helping sleep, but is weaker than the product prepared by the whole formula.

[0039] Traditional Chinese medicine believes that insomnia is mostly caused by heart and spleen deficiency or heart and kidney disharmony. Heart governs blood, and spleen governs transportation and transformation. Heart and spleen diseases can affect each other. Spleen dysfunction leads to insufficient blood and qi, which cannot nourish the heart. Heart blood deficiency and heart yang deficiency can cause palpitation, palpitation, insomnia, dreaminess, forgetfulness and other symptoms. The treatment principle of heart and spleen deficiency is to nourish the heart and spleen, nourish blood and calm the nerves. The most commonly used representative formula in ancient times is "Gui Pi Decoction" in "Ji Sheng Fang" and "Suan Zao Ren Decoction" in "Jin Kui Yao Lue". In some embodiments, the traditional Chinese medicine composition of the present application shows better effect of soothing the nerves and helping sleep than these two formulas.

[0040] The causes of heart and kidney disharmony are mostly caused by body yin deficiency and kidney yin damage, which leads to imbalance of heart and kidney yin and yang and cannot maintain balance. Heart belongs to fire, which is the yang of yang, and kidney belongs to water, which is the yin of yin. Kidney water deficiency cannot nourish the heart, which can cause heart yang to be alone, and heart fire cannot warm kidney water, which can cause kidney yin to be cold. The symptoms of heart and kidney disharmony are upper heat and lower cold, such as heart, insomnia, difficulty falling asleep, palpitation, dreaminess, dizziness, tinnitus, soreness of waist and knees, hot flashes, five heart heat, dry throat and other signs of yin deficiency and fire, the treatment principle is to nourish yin and lower fire, and to communicate heart and kidney. The most commonly used traditional Chinese medicine formula in modern times is "Liu Wei Di Huang Wan". In some embodiments, the traditional Chinese medicine composition of the present application also shows better effect of soothing the nerves and helping sleep than this formula.

[0041] Further, the process conditions of supercritical carbon dioxide extraction in S1 are: extraction pressure 15-25 MPa, extraction temperature 30-60℃, extraction time 1-3h.

[0042] Further, the extraction solvent in S2 is an ethanol / water system, the ethanol concentration is 0% to 100%, the extraction times are 1 to 3 times, each time is 1 to 3 hours, the concentration temperature is 40 to 75 DEG C, and the drying method is spray drying, vacuum drying or freeze drying.

[0043] Further, the mass ratio of HP-beta-CD to volatile oil A in S3 is 8:1 to 20:1, the inclusion temperature is 10 to 50 DEG C, and the inclusion time is 1 to 24 hours.

[0044] The application also provides an application of the traditional Chinese medicine composition with the effects of soothing the nerves and assisting sleep in preparation of a food or a medicine for soothing the nerves and assisting sleep.

[0045] Compared with the prior art, the application has the following beneficial effects:

[0046] The traditional Chinese medicine composition for soothing the nerves and assisting sleep can improve the symptoms of sleep difficulty, dreaminess and wakefulness, sleep deficiency, mental depression, and irritable temper of the insomnia patients, can deepen the sleep depth of the patients, prolong the sleep time, and make the insomnia patients maintain a good mental state after waking up. DETAILED DESCRIPTION

[0047] The technical solutions in the embodiments of the application will be described clearly and completely below. Obviously, the described embodiments are only some of the embodiments of the application, but not all the embodiments. Based on the embodiments in the application, all the other embodiments obtained by those skilled in the art without creative work fall within the protection scope of the application.

[0048] Embodiment 1

[0049] The composition of the traditional Chinese medicine composition in this embodiment is as follows: 10000g of jujube seed, 10000g of Platycladus orientalis seed, 10000g of Astragalus root, 10000g of longan aril, 10000g of Chinese wolfberry, 10000g of Fructus Corni, 4000g of Cuscuta japonica, 6000g of Atractylodes, 2000g of Angelica sinensis, 10000g of Poria cocos, 10000g of Polygala, 4000g of Panax ginseng, 6000g of Lilium brownii, 2000g of Saussurea involucrata, 2000g of Citrus reticulata, 2000g of licorice, 4000g of wheat, and 2000g of gamma-aminobutyric acid.

[0050] In the above medicines, jujube seed, Platycladus orientalis seed, Atractylodes, Angelica sinensis, Saussurea involucrata and Citrus reticulata are dried and crushed first, and then are put into a supercritical carbon dioxide extraction machine for extraction. The extraction pressure is 25 MPa, the extraction temperature is 60 DEG C, and the extraction time is 1.5 hours, so that volatile oil is obtained. The volatile oil is mixed with HP-beta-CD according to a mass ratio of 1:10, is stirred, and is included at 30 DEG C for 8 hours, so that an inclusion compound is obtained.

[0051] The above medicine powder after extracting volatile oil is combined with Astragalus, Longan, Chinese Wolfberry, Fructus Corni, Radix Morindae Officinalis, Poria, Polygala, Ginseng, Lily, Licorice and Wheat, and is extracted twice with 1200L and 800L water respectively, each for 1.5 hours. The filtrate is combined and is concentrated under reduced pressure, and is then spray dried. The powder is mixed with the above inclusion compound and GABA to obtain the whole prescription raw material, and the final product, TRP, is obtained.

[0052] Example 2

[0053] The composition of the whole prescription of the present example is as follows: Semen Ziziphi Spinosae 10000g, Semen Platycladi 10000g, Astragalus 10000g, Longan 10000g, Chinese Wolfberry 10000g, Fructus Corni 10000g, Radix Morindae Officinalis 4000g, Atractylodes 6000g, Angelica 2000g, Poria 10000g, Polygala 10000g, Ginseng 4000g, Lily 6000g, Saussurea 2000g, Tangerine Peel 2000g, Licorice 2000g, and Wheat 4000g.

[0054] The above medicines are combined, and are extracted twice with 1200L and 800L water respectively, each for 1.5 hours. The filtrate is combined and is concentrated under reduced pressure, and is then spray dried. The powder is mixed with 500g GABA to obtain the whole prescription water extraction raw material, and the final product, WRP, is obtained.

[0055] Example 3

[0056] The composition of the whole prescription of the present example is as follows: Semen Ziziphi Spinosae 10000g, Semen Platycladi 10000g, Astragalus 10000g, Longan 10000g, Chinese Wolfberry 10000g, Fructus Corni 10000g, Radix Morindae Officinalis 4000g, Atractylodes 6000g, Angelica 2000g, Poria 10000g, Polygala 10000g, Ginseng 4000g, Lily 6000g, Saussurea 2000g, Tangerine Peel 2000g, Licorice 2000g, and Wheat 4000g.

[0057] The above medicines are combined, and are extracted twice with 1200L and 800L water respectively, each for 1.5 hours. The filtrate is combined and is concentrated under reduced pressure, and is then spray dried. The powder is mixed with 500g GABA to obtain the whole prescription water extraction raw material, and the final product, WRP, is obtained.

[0058] The above medicine powder after extracting volatile oil is combined with Chinese Wolfberry, Fructus Corni, Radix Morindae Officinalis, Poria, Polygala, Ginseng, Lily, Licorice and Wheat, and is extracted twice with 500L and 300L 70% ethanol respectively, each for 1 hour. The filtrate is combined and is vacuum dried after being concentrated under reduced pressure. The powder is mixed with the above inclusion compound and 1000g GABA to obtain the partial prescription raw material, and the final product, JRP, is obtained.

[0059] Example 4

[0060] The composition of the herbal medicine composition in this embodiment, with the removal of some of the auxiliary herbs, is as follows: 10,000g of Ziziphus jujuba seed, 10,000g of Platycladus orientalis seed, 10,000g of Astragalus membranaceus, 10,000g of Longan pulp, 4,000g of Polygonum multiflorum stem, 10,000g of Poria cocos, 10,000g of Polygala tenuifolia, 4,000g of Panax ginseng, 6,000g of Lilium brownii, 2,000g of Aucklandia lappa, 2,000g of Citrus reticulata peel, 2,000g of Glycyrrhiza uralensis, and 4,000g of wheat.

[0061] Of the above-mentioned drugs, jujube seed, cypress seed, costus root, and dried tangerine peel were first dried and pulverized, then extracted using a supercritical carbon dioxide extractor. The extraction pressure was 20 MPa, the extraction temperature was 40℃, and the extraction time was 2 hours, yielding the raw material volatile oil. The volatile oil was then mixed with HP-β-CD at a mass ratio of 1:20 and stirred, and incorporated at 20℃ for 24 hours to obtain the inclusion complex.

[0062] The above-mentioned Chinese herbal powder raw materials after volatile oil extraction were combined with Astragalus membranaceus, Longan pulp, Polygonum multiflorum, Poria cocos, Polygala tenuifolia, Ginseng, Lilium brownii, Glycyrrhiza uralensis, and wheat. They were extracted twice by heating and refluxing with 1100L and 700L of 30% ethanol, 2 hours each time. After filtration, the filtrates were combined, concentrated under reduced pressure, and then freeze-dried. The powder was mixed with the above-mentioned inclusion complex and 2000g of γ-aminobutyric acid to obtain part of the formulation raw materials, numbered CRP.

[0063] Example 5

[0064] The composition of the medicinal and edible herbal combination in this embodiment is as follows: 10,000g of jujube seed, 10,000g of astragalus root, 10,000g of longan pulp, 10,000g of wolfberry, 10,000g of cornus fruit, 2,000g of angelica root, 10,000g of poria cocos, 4,000g of ginseng, 6,000g of lily bulb, 2,000g of dried tangerine peel, 2,000g of licorice root, and 4,000g of wheat.

[0065] Of the above-mentioned medicinal and edible herbs, jujube seed, angelica root, and dried tangerine peel were first dried and pulverized, then extracted using a supercritical carbon dioxide extractor. The extraction pressure was 25 MPa, the extraction temperature was 60℃, and the extraction time was 1.5 h, yielding the volatile oil of the raw materials. The volatile oil was then mixed with HP-β-CD at a mass ratio of 1:8 and stirred, and incorporated at 50℃ for 4 h to obtain the inclusion complex.

[0066] The above-mentioned Chinese herbal powder raw materials after volatile oil extraction were combined with Astragalus membranaceus, longan pulp, wolfberry, Cornus officinalis, Poria cocos, ginseng, lily bulb, licorice, and wheat. The raw materials were extracted twice by heating and boiling with 800L and 600L of water, 2 hours each time. After filtration, the filtrates were combined, concentrated under reduced pressure, and spray-dried. The powder was then mixed with the above-mentioned inclusion complex and 2000g of γ-aminobutyric acid to obtain the medicinal and edible raw material, designated YSP.

[0067] Example 6

[0068] The composition of the raw materials of Spleen-Returning Decoction: Bai Zhi 10000g, Dang Gui 10000g, Fu Ling 10000g, Huang Qi 10000g, Long Yan Rou 10000g, Renshen 10000g, Yuan Zhi 10000g, Suan Zao Ren 10000g, Mu Xiang 5000g, Gan Cao 3000g.

[0069] The above medicines are combined and extracted twice with 1000L and 800L of water, respectively, by heating and boiling, each for 1.5 hours. The filtrates are combined, concentrated under reduced pressure, and then spray-dried to obtain the extract raw powder, numbered GRP.

[0070] Example 7

[0071] The composition of the raw materials of Suan Zao Ren Decoction: Suan Zao Ren 18000g, Gan Cao 3000g, Zhi Mu 10000g, Fu Ling 10000g, Chuan Xiong 5000g.

[0072] The above medicines are combined and extracted twice with 500L and 400L of water, respectively, by heating and boiling, each for 1.5 hours. The filtrates are combined, concentrated under reduced pressure, and then spray-dried to obtain the extract raw powder, numbered SRP.

[0073] Example 8

[0074] The composition of the raw materials of Liuwei Dihuang Pills: Shudihuang 24000g, Shanzha 12000g, Shanyao 12000g, Zexie 9000g, Fuling 9000g, Mudanpi 9000g.

[0075] The above medicines are combined and extracted twice with 750L and 600L of water, respectively, by heating and boiling, each for 1.5 hours. The filtrates are combined, concentrated under reduced pressure, and then spray-dried to obtain the extract raw powder, numbered LRP.

[0076] Example 9

[0077] Preparation of Granules of the Whole Formula: Take 10000g of the raw material TRP powder of Example 1, add 15000g of dextrin, wet granulate with an appropriate amount of ethanol, dry below 80°C, sieve, and pack 6g per bag to obtain KTRP, which is used for subsequent clinical trials.

[0078] Example 10

[0079] Preparation of Solid Beverage: Take 10000g of the raw material YSP powder of Example 5, add 20000g of malt dextrin, 4000g of white sugar, 1000g of citric acid, and 1500g of mogroside, wet with an appropriate amount of water, mix, sieve with a 10-mesh sieve, dry below 70°C, sieve, and pack 6g per bag to obtain GYSP, which is used for subsequent clinical trials.

[0080] Example 11

[0081] Preparation of Guipi Decoction Granules: Take 10000g of the raw material GRP powder of Example 6, add 15000g of dextrin, wet granulate with an appropriate amount of ethanol, dry below 80°C, size the granules, and pack 6g per bag to obtain KGRP, which is used for subsequent clinical trials.

[0082] Example 12

[0083] Preparation of Suanzaoren Decoction Granules: Take 10000g of the raw material SRP powder of Example 7, add 15000g of dextrin, wet granulate with an appropriate amount of ethanol, dry below 80°C, size the granules, and pack 6g per bag to obtain KSRP, which is used for subsequent clinical trials.

[0084] Example 13

[0085] Preparation of Liuweidihuang Pill Formula Granules: Take 10000g of the raw material LRP powder of Example 8, add 15000g of dextrin, wet granulate with an appropriate amount of ethanol, dry below 80°C, size the granules, and pack 6g per bag to obtain KLRP, which is used for subsequent clinical trials.

[0086] Example 14

[0087] Preparation of Oral Liquid: Take 100g of the TRP raw material of Example 1, dissolve in 2000mL of water, and fill into 200 10mL oral liquid bottles. Sterilize to obtain the oral liquid.

[0088] Example 15

[0089] Preparation of Paste: Prepare the medicinal materials in an amount of one-tenth of Example 1, and extract using the same extraction process. After extracting the volatile oil, combine the remaining 11 medicinal materials with the extracted medicinal powder, and extract twice with 120L and 80L of water, respectively, each time for 1.5hr. Filter and combine the filtrates, and concentrate under reduced pressure to obtain a thick paste. Add an appropriate amount of honey to the thick paste, heat, and slowly stir the paste until dense bubbles appear. Stop heating, add the inclusion compound and γ-aminobutyric acid to the thick paste, and stir until uniform. Fill and seal the paste, and allow it to cool to room temperature after about 24 hours.

[0090] Example 16

[0091] Preparation of pills: Take an appropriate amount of honey, heat at 120°C, until the honey appears more red-brown bubbles, and has a luster. At this time, the viscosity of the honey is larger, stop heating. Take 100g of TRP powder of Example 1, slowly add the prepared honey to the drug powder with a spoon, constantly stirring, so that the honey and drug powder are fully mixed and uniform, and then into a mass. Take a small amount of sesame oil on the palm, rub the above mass, first into 30 lumps, rub into a strip, each cut into 10 small sections, each section rub into a pill. After the pills sweat, dry the hard outer surface, and then pack with wax shell, stored in a cool dry place.

[0092] Example 17

[0093] Preparation of capsules: Take 100g of TRP raw material of Example 1, add 100g of dextrin, 150g of microcrystalline cellulose, mix well, then add an appropriate amount of ethanol to make a soft material, 16 mesh sieve granulation, 20 mesh sieve granulation, mix in a small amount of talc after drying, and then put into the selected empty capsules.

[0094] Example 18: Preparation of tablets

[0095] Take 200g of TRP raw material of Example 1, add 150g of microcrystalline cellulose, 150g of starch, mix well, add ethanol to make a soft material, dry after granulation, add 20g of magnesium stearate, 15g of micronized silica gel, mix well, and then press into tablets of a certain specification.

[0096] Example 19

[0097] Subthreshold dose of sodium barbital hypnotic test:

[0098] Test method: Take the raw material medicine of example 1-8, take 288 healthy mice, randomly divided into 25 groups, 12 in each group: (1) blank control group, intragastrically administered with distilled water; (2) TRP low dose group 100mg / kg; (3) TRP middle dose group 200mg / kg; (4) TRP high dose group 400mg / kg; (5) WRP low dose group 100mg / kg; (6) WRP middle dose group 200mg / kg; (7) WRP high dose group 400mg / kg; (8) JRP low dose group 100mg / kg; (9) JRP middle dose group 200mg / kg; (10) JRP high dose group 400mg / kg; (11) CRP low dose group 100mg / kg; (12) CRP middle dose group 200mg / kg; (13) CRP high dose group 400mg / kg; (14) YSP low dose group 100mg / kg; (15) YSP middle dose group 200mg / kg; (16) YSP high dose group 400mg / kg; (17) GRP low dose group 100mg / kg; (18) GRP middle dose group 200mg / kg; (19) GRP high dose group 400mg / kg; (20) SRP low dose group 100mg / kg; (21) SRP middle dose group 200mg / kg; (22) SRP high dose group 400mg / kg; (23) LRP low dose group 100mg / kg; (24) LRP middle dose group 200mg / kg; (25) LRP high dose group 400mg / kg. 30min after the last intragastric administration, the mice were injected intraperitoneally with a threshold dose of sodium barbital 150mg / kg, and the loss of righting reflex was used as the index of sleep. The number of mice that fell asleep after the administration of the test substance and the threshold dose of sodium barbital was observed, and the sleep rate (the number of sleeping animals / total number of animals) was calculated to compare the effects of the test substances on the sleep rate of the mice.

[0099] The experimental results are shown in Table 1.

[0100] Table 1 Effects of various compositions on the sleep rate of mice

[0101]

[0102] As can be seen from Table 1, the low, middle and high dose groups of TRP and the other groups compared with the control group can significantly improve the sleep rate of mice. The remaining compositions also have a certain sleep-promoting effect, but the sleep rate under the same dose is weaker than that of the TRP group. This result shows that it has a promoting effect on the sleep rate of mice injected with a threshold dose of sodium barbital.

[0103] Example 20

[0104] Barbital sodium sleep latency test:

[0105] Test method: Take the raw material medicine of examples 1-8, take 288 healthy mice, randomly divided into 25 groups, 12 in each group: (1) blank control group, intragastrically administered with distilled water; (2) TRP low dose group 100 mg / kg; (3) TRP middle dose group 200 mg / kg; (4) TRP high dose group 400 mg / kg; (5) WRP low dose group 100 mg / kg; (6) WRP middle dose group 200 mg / kg; (7) WRP high dose group 400 mg / kg; (8) JRP low dose group 100 mg / kg; (9) JRP middle dose group 200 mg / kg; (10) JRP high dose group 400 mg / kg; (11) CRP low dose group 100 mg / kg; (12) CRP middle dose group 200 mg / kg; (13) CRP high dose group 400 mg / kg; (14) YSP low dose group 100 mg / kg; (15) YSP middle dose group 200 mg / kg; (16) YSP high dose group 400 mg / kg; (17) GRP low dose group 100 mg / kg; (18) GRP middle dose group 200 mg / kg; (19) GRP high dose group 400 mg / kg; (20) SRP low dose group 100 mg / kg; (21) SRP middle dose group 200 mg / kg; (22) SRP high dose group 400 mg / kg; (23) LRP low dose group 100 mg / kg; (24) LRP middle dose group 200 mg / kg; (25) LRP high dose group 400 mg / kg. 30 min after the last intragastric administration, the mice were intraperitoneally injected with sodium barbital 300 mg / kg, and the time from injection of sodium barbital to disappearance of the righting reflex of the mice was recorded, i.e. sleep latency. The effects of each test substance on the sleep latency of mice were compared.

[0106] The experimental results are shown in Table 2.

[0107] Table 2 Effects of each composition on sleep latency of mice ± SD)

[0108]

[0109] Note: compared with the control group *P<0.05; **P<0.01; ***P<0.001.

[0110] As can be seen from Table 2, the low, middle and high dose groups of TRP and other groups compared with the control group, the sleep latency of mice showed significant difference, and the difference had statistical significance (*P<0.05; **P<0.01; P<0.001), and many groups showed dose-dependent relationship. The rest of the compositions also had certain activity, but were weaker than the TRP group under the same dose. This result shows that it has a promoting effect on shortening the sleep latency of sodium barbital mice.

[0111] Example 21

[0112] Prolonged pentobarbital sodium sleeping time test:

[0113] Test method: Take the raw materials of Examples 1-8, take 288 healthy mice, randomly divided into 25 groups, 12 in each group: (1) blank control group, intragastrically administered with distilled water; (2) TRP low-dose group 100 mg / kg; (3) TRP medium-dose group 200 mg / kg; (4) TRP high-dose group 400 mg / kg; (5) WRP low-dose group 100 mg / kg; (6) WRP medium-dose group 200 mg / kg; (7) WRP high-dose group 400 mg / kg; (8) JRP low-dose group 100 mg / kg; (9) JRP medium-dose group 200 mg / kg; (10) JRP high-dose group 400 mg / kg; (11) CRP low-dose group 100 mg / kg; (12) CRP medium-dose group 200 mg / kg; (13) CRP high-dose group 400 mg / kg; (14) YSP low-dose group 100 mg / kg; (15) YSP medium-dose group 200 mg / kg; (16) YSP high-dose group 400 mg / kg; (17) GRP low-dose group 100 mg / kg; (18) GRP medium-dose group 200 mg / kg; (19) GRP high-dose group 400 mg / kg; (20) SRP low-dose group 100 mg / kg; (21) SRP medium-dose group 200 mg / kg; (22) SRP high-dose group 400 mg / kg; (23) LRP low-dose group 100 mg / kg; (24) LRP medium-dose group 200 mg / kg; (25) LRP high-dose group 400 mg / kg. 30 min after the last intragastric administration, the mice were intraperitoneally injected with pentobarbital sodium 60 mg / kg, and the disappearance of the righting reflex was taken as the sleep index. The time from the disappearance of the righting reflex to the recovery was observed, i.e. the sleep duration. The effects of each test substance on the sleep time of mice were compared.

[0114] The experimental results are shown in Table 3.

[0115] Table 3 Effects of each composition on the sleep time of mice ±SD)

[0116]

[0117] Note: *P<0.05; **P<0.01; ***P<0.001 compared with the control group.

[0118] As shown in Table 3, the low, medium and high dose groups of TRP and other groups showed significant differences in the sleep duration of mice compared with the control group, and the differences had statistical significance (*P<0.05; **P<0.01; P<0.001), and many groups showed dose-dependent relationship. Each group of compositions also had certain activity, but was weaker than the group of TRP at the same dose. This result showed that it had a promoting effect on prolonging the sleep time of mice injected with pentobarbital sodium.

[0119] Example 22

[0120] Human sleep aid test:

[0121] Test method: The preparations of Examples 9-13 were divided into 6 g / bag. 90 people prone to insomnia were randomly selected to investigate the sleep improvement after use by questionnaire. The inclusion criteria were that the subjects met the conditions after physical examination, and there was no food or drug related to the function of the subjects in the recent period. Randomly divided into 5 groups, 15 cases in each group, respectively blank group (taking granules without drugs), KTRP sample group, GYSP sample group, KGRP sample group, KSRP sample group and KLRP sample group. The age of the blank group was 35-65 years old, and the average age was 48 years old; the age of the KTRP group was 36-68 years old, and the average age was 48 years old; the age of the GYSP group was 33-66 years old, and the average age was 48 years old; the age of the KGRP group was 34-64 years old, and the average age was 48 years old; the age of the KSRP group was 36-67 years old, and the average age was 48 years old; the age of the KLRP group was 35-68 years old, and the average age was 48 years old. There was no statistically significant difference (P>0.05) in the general data such as gender, age and physical signs of the six groups, and they were comparable. The six groups of people took one sample each time, and took it 1-2 hours before going to bed every night, and continued to take it for 2 weeks. Since the sleep time cannot be recorded, the sleep duration was recorded with the bed time as the starting time and the wake-up time as the end time. The subjects with prolonged sleep time were effective, and if the subjects' sleep time was not prolonged, but the self-conscious mental state after waking up the next day was significantly improved compared with before taking the drug, it was recorded as significant effect. The total effective rate was calculated, and the results are shown in Table 4.

[0122] Table 4 Sleep improvement of subjects after taking for 2 weeks

[0123]

[0124] As shown in Table 4, compared with the blank group, the five test groups were effective, but the total effective rate of the KTRP group reached 93%, which was higher than the other five groups, indicating that the present application had a more outstanding effect on improving sleep.

[0125] Animal pharmacological experiments and clinical tests prove that the traditional Chinese medicine composition has remarkable effects in improving sleep difficulty, improving sleep quality, and prolonging sleep time of patients.

[0126] Example 23: finished traditional Chinese medicine composition TRP-1

[0127] The composition of the full prescription traditional Chinese medicine composition of this example is: 1100g of Suanzaoren, 1100g of Baiziren, 1100g of Huangqi, 1100g of Longyanrou, 1100g of Gouqi, 1100g of Shanzhuyu, 450g of Yijiaoteng, 550g of Baizhu, 220g of Danggui, 1100g of Fuling, 1100g of Yuanzhi, 450g of Renshen, 550g of Baihe, 210g of Muxiang, 210g of Chenpi, 220g of Gancao, 450g of wheat, and 210g of gamma-aminobutyric acid.

[0128] Among the above drugs, Suanzaoren, Baiziren, Baizhu, Danggui, Muxiang, and Chenpi are dried and crushed, and then put into a supercritical carbon dioxide extraction machine for extraction. The extraction pressure is 15 MPa, the extraction temperature is 30°C, and the extraction time is 3h, to obtain raw material volatile oil. The volatile oil is mixed with HP-β-CD at a mass ratio of 1:10, stirred, and packed at 30°C for 8.5h to obtain a clathrate.

[0129] The traditional Chinese medicine powder raw material after extraction of volatile oil is combined with Huangqi, Longyanrou, Gouqi, Shanzhuyu, Yijiaoteng, Fuling, Yuanzhi, Renshen, Baihe, Gancao, and wheat, and then heated and boiled with 115L and 75L of water for extraction twice, each for 1.5h. After filtration, the filtrates are combined, concentrated under reduced pressure, and then spray dried. The obtained powder is mixed with the above clathrate and gamma-aminobutyric acid to obtain the full prescription raw material, and the finished traditional Chinese medicine composition, numbered TRP-1, is obtained.

[0130] Example 24: finished traditional Chinese medicine composition TRP-2

[0131] The composition of the full prescription traditional Chinese medicine composition of this example is: 950g of Suanzaoren, 950g of Baiziren, 950g of Huangqi, 950g of Longyanrou, 950g of Gouqi, 950g of Shanzhuyu, 380g of Yijiaoteng, 650g of Baizhu, 180g of Danggui, 950g of Fuling, 950g of Yuanzhi, 380g of Renshen, 650g of Baihe, 190g of Muxiang, 190g of Chenpi, 180g of Gancao, 380g of wheat, and 190g of gamma-aminobutyric acid.

[0132] Among the above drugs, Suanzaoren, Baiziren, Baizhu, Danggui, Muxiang, and Chenpi are dried and crushed, and then put into a supercritical carbon dioxide extraction machine for extraction. The extraction pressure is 25 MPa, the extraction temperature is 60°C, and the extraction time is 1h, to obtain raw material volatile oil. The volatile oil is mixed with HP-β-CD at a mass ratio of 1:10, stirred, and packed at 30°C for 7.5h to obtain a clathrate.

[0133] The above-mentioned Chinese medicine powder raw material after extracting volatile oil is combined with Astragalus, Longan, Medlar, Cornus, Moonseed, Poria, Polygala, Ginseng, Lily, Licorice and Wheat, and is extracted twice with 125L and 85L of water respectively, each for 1.5 hours. The filtrate is combined after filtration, and is spray-dried after being concentrated under reduced pressure. The obtained powder is mixed with the above-mentioned inclusion compound and gamma-aminobutyric acid to obtain the whole prescription raw material, and the finished Chinese medicine composition numbered TRP-2 is obtained.

[0134] Example 25: Finished Chinese medicine composition TRP-3

[0135] The composition of the whole prescription Chinese medicine composition of the present example is as follows: Suanzaoren 1050g, Baiziren 1050g, Huangqi 1050g, Longyanrou 1050g, Gouqi 1050g, Shanzhuyu 1050g, Yejiaoteng 420g, Baizhu 500g, Danggui 210g, Fuling 1050g, Fuzi 1050g, Renshen 420g, Baihe 500g, Muxiang 205g, Chenpi 205g, Gancao 210g, and Wheat 420g, and gamma-aminobutyric acid 205g.

[0136] The above-mentioned Chinese medicine powder raw material after extracting volatile oil is combined with Astragalus, Longan, Medlar, Cornus, Moonseed, Poria, Polygala, Ginseng, Lily, Licorice and Wheat, and is extracted twice with 125L and 85L of water respectively, each for 1.5 hours. The filtrate is combined after filtration, and is spray-dried after being concentrated under reduced pressure. The obtained powder is mixed with the above-mentioned inclusion compound and gamma-aminobutyric acid to obtain the whole prescription raw material, and the finished Chinese medicine composition numbered TRP-2 is obtained.

[0137] The above-mentioned Chinese medicine powder raw material after extracting volatile oil is combined with Astragalus, Longan, Medlar, Cornus, Moonseed, Poria, Polygala, Ginseng, Lily, Licorice and Wheat, and is extracted twice with 115L and 75L of water respectively, each for 1.5 hours. The filtrate is combined after filtration, and is spray-dried after being concentrated under reduced pressure. The obtained powder is mixed with the above-mentioned inclusion compound and gamma-aminobutyric acid to obtain the whole prescription raw material, and the finished Chinese medicine composition numbered TRP-3 is obtained.

[0138] Example 26: Finished Chinese medicine composition TRP-4

[0139] The composition of the whole prescription Chinese medicine composition of the present example is as follows: Suanzaoren 980g, Baiziren 980g, Huangqi 980g, Longyanrou 980g, Gouqi 980g, Shanzhuyu 980g, Yejiaoteng 390g, Baizhu 620g, Danggui 190g, Fuling 980g, Fuzi 980g, Renshen 390g, Baihe 620g, Muxiang 195g, Chenpi 195g, Gancao 190g, and Wheat 390g, and gamma-aminobutyric acid 195g.

[0140] Among the above drugs, take the dried and powdered Zizyphus jujuba, Platycladus orientalis, Atractylodes macrocephala, Angelica sinensis, Saussurea involucrata, and Citrus reticulata, and put them into a supercritical carbon dioxide extraction machine for extraction. The extraction pressure is 24.5 MPa, the extraction temperature is 60°C, and the extraction time is 1.5 h, to obtain raw material volatile oil. Mix the volatile oil with HP-β-CD according to a mass ratio of 1:10, stir, and pack at 30°C for 7.8 h, to obtain a pack.

[0141] The above-mentioned traditional Chinese medicine powder raw material after extraction of volatile oil is combined with Astragalus membranaceus, Longan, Lycium barbarum, Cornus officinalis, Marsdenia tenacissima, Poria cocos, Polygala tenuifolia, Panax ginseng, Lilium brownii, Glycyrrhiza uralensis, and Triticum aestivum, and is heated and boiled with 122 L and 82 L of water for extraction twice, each for 1.5 h. After filtration, the filtrates are combined, concentrated under reduced pressure, and spray dried. The obtained powder is mixed with the above-mentioned pack and γ-aminobutyric acid to obtain a whole prescription raw material, to obtain a finished traditional Chinese medicine composition, numbered TRP-4.

[0142] Example 27: Finished traditional Chinese medicine composition TRP-5

[0143] The composition of the whole prescription traditional Chinese medicine composition of this example is as follows: Zizyphus jujuba 1120 g, Platycladus orientalis 1120 g, Astragalus membranaceus 1120 g, Longan 1120 g, Lycium barbarum 1120 g, Cornus officinalis 1120 g, Marsdenia tenacissima 440 g, Atractylodes macrocephala 580 g, Angelica sinensis 230 g, Poria cocos 1120 g, Polygala tenuifolia 1120 g, Panax ginseng 440 g, Lilium brownii 580 g, Saussurea involucrata 215 g, Citrus reticulata 215 g, Glycyrrhiza uralensis 230 g, and Triticum aestivum 440 g, and γ-aminobutyric acid 215 g.

[0144] Among the above drugs, take the dried and powdered Zizyphus jujuba, Platycladus orientalis, Atractylodes macrocephala, Angelica sinensis, Saussurea involucrata, and Citrus reticulata, and put them into a supercritical carbon dioxide extraction machine for extraction. The extraction pressure is 24.5 MPa, the extraction temperature is 60°C, and the extraction time is 1.5 h, to obtain raw material volatile oil. Mix the volatile oil with HP-β-CD according to a mass ratio of 1:10, stir, and pack at 30°C for 7.8 h, to obtain a pack.

[0145] The above-mentioned traditional Chinese medicine powder raw material after extraction of volatile oil is combined with Astragalus membranaceus, Longan, Lycium barbarum, Cornus officinalis, Marsdenia tenacissima, Poria cocos, Polygala tenuifolia, Panax ginseng, Lilium brownii, Glycyrrhiza uralensis, and Triticum aestivum, and is heated and boiled with 122 L and 82 L of water for extraction twice, each for 1.5 h. After filtration, the filtrates are combined, concentrated under reduced pressure, and spray dried. The obtained powder is mixed with the above-mentioned pack and γ-aminobutyric acid to obtain a whole prescription raw material, to obtain a finished traditional Chinese medicine composition, numbered TRP-4.

[0146] Although embodiments of the present application have been shown and described, it is to be understood that various modifications, substitutions, replacements and changes can be made to these embodiments without departing from the principles and spirit of the present application, and the scope of the present application is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition with calming and sleep-aiding effects, characterized in that, include: The ingredients include: jujube seed, cypress seed, astragalus, longan pulp, wolfberry, cornus officinalis, polygonum multiflorum, atractylodes macrocephala, angelica sinensis, poria cocos, polygala tenuifolia, ginseng, lily bulb, costus root, tangerine peel, licorice, wheat, and γ-aminobutyric acid.

2. The traditional Chinese medicine composition with sedative and sleep-aiding effects according to claim 1, characterized in that, The mass fractions of each raw material are as follows: Sour jujube seed 1-50 parts, arborvitae seed 1-50 parts, astragalus 1-50 parts, longan pulp 1-50 parts, wolfberry 1-50 parts, cornus officinalis 1-50 parts, polygonum multiflorum 1-20 parts, atractylodes macrocephala 1-30 parts, angelica sinensis 1-10 parts, poria cocos 1-50 parts, polygala tenuifolia 1-50 parts, ginseng 1-20 parts, lily bulb 1-30 parts, costus root 1-10 parts, tangerine peel 1-10 parts, licorice root 1-10 parts, wheat 1-20 parts, γ-aminobutyric acid 1-10 parts.

3. The traditional Chinese medicine composition with sedative and sleep-aiding effects according to claim 2, characterized in that, Dosage forms of traditional Chinese medicine compositions include solid beverages, oral liquids, tablets, capsules, granules, pills, and ointments.

4. A method for preparing a traditional Chinese medicine composition with sedative and sleep-aiding effects as described in any one of claims 1-3, characterized in that, Includes the following steps: S1. The jujube seed, cypress seed, atractylodes macrocephala, angelica sinensis, costus root, and dried tangerine peel are dried and pulverized, and then subjected to supercritical carbon dioxide extraction to obtain raw material volatile oil A; S2. Grind Astragalus membranaceus, longan pulp, wolfberry, cornus officinalis, Polygonum multiflorum, Poria cocos, Polygala tenuifolia, ginseng, lily bulb, licorice, and wheat into powder, combine with the residue after extracting volatile oil in S1, and then extract, concentrate, and dry to obtain raw material powder B. S3. The volatile oil A obtained in S1 is encapsulated with HP-β-CD and dried to obtain raw material powder C; S4. Mix raw material powder B, raw material powder C and γ-aminobutyric acid to obtain a traditional Chinese medicine composition.

5. The method for preparing a traditional Chinese medicine composition with sedative and sleep-aiding effects according to claim 4, characterized in that, The process conditions for supercritical carbon dioxide extraction in S1 are: extraction pressure 15-25 MPa, extraction temperature 30-60℃, and extraction time 1-3 h.

6. The method for preparing a traditional Chinese medicine composition with sedative and sleep-aiding effects according to claim 5, characterized in that, The solvent for extraction in S2 is an ethanol / water system with an ethanol concentration of 0% to 100%. The extraction is performed 1 to 3 times, each time for 1 to 3 hours. The concentration temperature is 40 to 75°C. The drying method is spray drying, vacuum drying, or freeze drying.

7. A method for preparing a traditional Chinese medicine composition with sedative and sleep-aiding effects according to claim 6, characterized in that, In S3, the mass ratio of HP-β-CD to volatile oil A is 8:1 to 20:1, the inclusion temperature is 10-50℃, and the inclusion time is 1-24h.

8. The use of a traditional Chinese medicine composition with sedative and sleep-aiding effects as described in any one of claims 1-3 in the preparation of sedative and sleep-aiding foods or medicines.

Images