Composition for improving sleep and preparation method thereof, health product and application thereof

Abstract

The application provides a traditional Chinese medicine composition for improving sleep, a preparation method, health care products and application, and relates to the technical field of health care products. The traditional Chinese medicine composition has the effects of soothing the nerves, tonifying and regulating by using spina date, eucommia ulmoides as monarchs, anemarrhena asphodeloides, chuanxiong rhizome and radix codonopsis as ministers, poria cocos as assistant and licorice as enforcer. The traditional Chinese medicine composition is clear in hierarchy and orderly in primary and secondary aspects, and is suitable for the syndrome of liver and kidney deficiency, disturbed spirit by virtual fire, and heart-kidney disharmony. The traditional Chinese medicine composition is suitable for the syndrome of body deficiency, overthinking, liver and kidney deficiency, virtual fire ascending, heart-kidney disharmony, night insomnia, dreaminess, low mood, unstable mood, easy to sigh, dizziness, tinnitus, bitter taste, dry throat, red tongue, greasy moss, slippery pulse and the like.

Description

Technical Field

[0001] This invention belongs to the field of health product technology, specifically relating to a composition that helps improve sleep, its preparation method, health products, and applications. Background Technology

[0002] In Western medicine, insomnia is a disease characterized by difficulty falling asleep, poor sleep quality, frequent dreams, and easy awakenings. With rapid socioeconomic development, the pressure from life and work is increasing, leading to a rising incidence of insomnia, which continues to increase.

[0003] In traditional Chinese medicine, insomnia is referred to as "inability to lie down" or "inability to sleep." It is believed that the main causes of "insomnia" are stagnation of Yang Qi, imbalance of Yin and Yang, disharmony of Qi and blood, disharmony of the internal organs, and restlessness of the mind. Therefore, harmonizing the functions of the five internal organs and calming the mind are the key to treating "insomnia".

[0004] (1) The heart governs the mind and controls sleep. If the heart is not healthy, it is easy for the heart fire to be too strong, which leads to too many thoughts and affects the quality of sleep. This manifests as difficulty falling asleep, insomnia and dreaming, feeling unrefreshed after waking up, and even feeling more tired and sleepy.

[0005] (2) The liver governs the free flow of qi and has the function of regulating emotions. When liver qi is not flowing smoothly, it can lead to emotional "loss of control", resulting in discomfort such as feeling depressed, anxious, stressed, preoccupied, and depressed, which in turn affects sleep.

[0006] (3) The spleen governs transportation and transformation. Excessive worry and anxiety can lead to the heart not being properly nourished, resulting in spleen deficiency and impaired transportation. As a result, the body's natural resources are depleted, and over time, the disease can damage the internal organs and blood. The defensive qi cannot retain yin internally, leading to an imbalance of yin and yang, which ultimately causes insomnia.

[0007] (4) Impaired spleen and stomach function, food stagnation in the middle jiao, spleen failing to ascend clear qi and stomach failing to descend turbid qi, obstruction of yin and yang interaction often leads to insomnia.

[0008] (5) There is a balance between water and fire between the heart and kidneys. If the balance between yin and yang, water and fire between the heart and kidneys is disrupted, it will lead to ataxia, resulting in heart and kidney disharmony and insomnia.

[0009] Currently, most chemical drugs or health products used to treat sleep disorders are sedatives and hypnotics for the central nervous system. However, long-term use can lead to side effects such as drug dependence, respiratory depression, and damage to cognitive function and the mental system. Traditional Chinese medicine has the medical tradition of food and medicine sharing the same origin, and using Chinese medicine to relieve insomnia has irreplaceable advantages. Summary of the Invention

[0010] The first objective of this invention is to provide a traditional Chinese medicine composition that helps improve sleep.

[0011] A second objective of this invention is to provide a method for preparing the above-mentioned traditional Chinese medicine composition that helps improve sleep.

[0012] A third objective of this invention is to provide a health product comprising the above-mentioned traditional Chinese medicine composition that helps improve sleep.

[0013] A fourth objective of this invention is to provide the application of the above-mentioned traditional Chinese medicine composition or health product that helps improve sleep.

[0014] To achieve the above-mentioned objectives of this invention, the present invention adopts the following technical solution: This invention provides a traditional Chinese medicine composition that helps improve sleep, comprising the following raw materials in parts by weight: 10-96 parts of Eucommia ulmoides, 5-80 parts of Ziziphus jujuba var. spinosa, 5-72 parts of Codonopsis pilosula, 10-96 parts of Anemarrhena asphodeloides, 10-96 parts of Ligusticum chuanxiong, 10-96 parts of Poria cocos, and 5-72 parts of Glycyrrhiza uralensis.

[0015] Preferably, the traditional Chinese medicine composition provided by the present invention is made from the following raw materials in parts by weight: 32-96 parts of Eucommia ulmoides, 13-80 parts of Ziziphus jujuba var. spinosa, 32-72 parts of Codonopsis pilosula, 32-96 parts of Anemarrhena asphodeloides, 32-96 parts of Ligusticum chuanxiong, 32-96 parts of Poria cocos, and 16-72 parts of Glycyrrhiza uralensis.

[0016] In a preferred embodiment, the traditional Chinese medicine composition used consists of: 64 parts Eucommia ulmoides, 26 parts Ziziphus jujuba var. spinosa, 48 parts Codonopsis pilosula, 64 parts Anemarrhena asphodeloides, 64 parts Ligusticum chuanxiong, 64 parts Poria cocos, and 48 parts Glycyrrhiza uralensis.

[0017] This invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition that helps improve sleep, comprising the following steps: Step (1): Extraction: Eucommia ulmoides, Ziziphus jujuba var. spinosa, Codonopsis pilosula, Anemarrhena asphodeloides, Ligusticum chuanxiong, Poria cocos and Glycyrrhiza uralensis are extracted using the traditional hot water reflux extraction method. The extraction time is 0.5-2.0 hours, and the number of extractions is 1-3 times. The amount of water used each time is 5-8 times that of the raw material. Step (2): Concentration and drying: The extract is concentrated to a clear paste with a relative density of 1.10-1.15 at 60℃, and then spray-dried at an inlet air temperature of 160-200℃ and an outlet air temperature of 90-100℃ to obtain spray-dried powder.

[0018] Preferably, the extraction is performed twice in step (1). The amount of water used in the first extraction is 6 times that of the raw material, and the extraction time is 1.5 hours. The amount of water used in the second extraction is 5 times that of the raw material, and the extraction time is 1 hour.

[0019] Preferably, the temperature for concentration and drying in step (2) is 70-80°C.

[0020] As a further preferred embodiment of the preparation method of the composition described in this invention, it also includes the processing of traditional Chinese medicinal materials: Eucommia: Remove impurities, cut into 2-4cm sections, and rinse before feeding; Sour jujube seeds: Remove impurities and crush; Codonopsis pilosula: Remove impurities, cut into 2-4cm sections, and rinse before feeding; Anemarrhena asphodeloides: Remove impurities, break into small pieces of about 2cm, and rinse before feeding; Chuanxiong: Remove impurities, break into small pieces of about 2cm, and rinse before feeding; Poria cocos: Remove impurities and add directly to the feed; Licorice: Prepared slices, added directly to the ingredients.

[0021] As a further preferred embodiment of the preparation method of the traditional Chinese medicine composition described in this invention, the method further includes pretreatment of the raw materials: soaking the above 7 raw materials for 30 minutes.

[0022] As a further preferred embodiment of the preparation method of the composition described in this invention, the method further includes pulverization: the spray-dried powder is pulverized through a 100-mesh sieve.

[0023] The present invention also provides a health product comprising the above-mentioned traditional Chinese medicine composition that helps improve sleep and excipients.

[0024] Preferably, based on the above-mentioned technical solution of the present invention, the excipients include any one or a combination of at least two of corn starch, microcrystalline cellulose, silicon dioxide or magnesium stearate.

[0025] Preferably, based on the above-described technical solution of the present invention, the dosage form of the health product includes any one of capsules, tablets, powders, decoctions, granules, oral liquids, granules, mixtures, or solid beverages. Preferably, the health product is a capsule, which can mask unpleasant odors of medicinal materials, improve drug stability, and has a rapid onset of action.

[0026] Another object of the present invention is to provide the application of the aforementioned traditional Chinese medicine composition or health product in the fields of calming the mind and aiding sleep, tonifying qi and strengthening the spleen, nourishing blood and liver, and calming the mind and strengthening the kidneys.

[0027] The recommended dosage of the health supplement provided by this invention is as follows: Take two capsules with warm water after meals, twice a day.

[0028] Analysis of the composition of the present invention: Eucommia ulmoides: [Properties and Channels Entered] Sweet, warm. Enters the Liver and Kidney channels. [Functions and Indications] Tonifies the Liver and Kidneys, strengthens tendons and bones, and calms the fetus. Used for Liver and Kidney deficiency, lower back and knee pain, weakness of tendons and bones, dizziness, threatened miscarriage, and threatened abortion.

[0029] Sour jujube seed: [Properties and Channels Entered] Sweet, sour, neutral. Enters the liver, gallbladder, and heart channels. [Functions and Indications] Nourishes the heart and liver, calms the mind and soothes the nerves, astringes sweat, and generates body fluids. Used for insomnia due to deficiency and restlessness, palpitations and excessive dreaming, excessive sweating due to physical weakness, and thirst due to fluid depletion.

[0030] Codonopsis pilosula: [Properties and Channels Entered] Sweet, neutral. Enters the spleen and lung channels. [Functions and Indications] Strengthens the spleen and lungs, nourishes blood and generates fluids. Used for spleen and lung qi deficiency, poor appetite and fatigue, cough and wheezing, qi and blood deficiency, sallow complexion, palpitations and shortness of breath, thirst due to fluid depletion, and internal heat and thirst.

[0031] Anemarrhena asphodeloides: [Properties and Channels Entered] Bitter, sweet, cold. Enters the Lung, Stomach, and Kidney channels. [Functions and Indications] Clears heat and drains fire, nourishes Yin and moistens dryness. Used for exogenous febrile diseases, high fever and thirst, dry cough due to lung heat, steaming bone fever, internal heat and thirst, and constipation due to intestinal dryness.

[0032] Chuanxiong (Ligusticum striatum): [Properties and Channels Entered] Pungent, warm. Enters the Liver, Gallbladder, and Pericardium channels. [Functions and Indications] Activates blood circulation and promotes qi flow, dispels wind and relieves pain. Used for chest pain, stabbing pain in the chest and hypochondrium, swelling and pain from falls, irregular menstruation, amenorrhea and dysmenorrhea, abdominal masses and pain, headache, and rheumatic pain.

[0033] Poria cocos: [Properties and Channels Entered] Sweet, bland, neutral. Enters the Heart, Lung, Spleen, and Kidney channels. [Functions and Indications] Promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. Used for edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations, and insomnia.

[0034] Licorice: [Properties and Channels Entered] Sweet, neutral. Enters the Heart, Lung, Spleen, and Stomach channels. [Functions and Indications] Tonifies the spleen and replenishes qi, clears heat and detoxifies, resolves phlegm and relieves cough, alleviates spasms and pain, and harmonizes other herbs. Used for spleen and stomach weakness, fatigue, palpitations, shortness of breath, cough with excessive phlegm, abdominal and limb spasms and pain, carbuncles and boils, and to alleviate the toxicity and harshness of other drugs.

[0035] This invention uses Eucommia ulmoides and Ziziphus jujuba var. spinosa as the principal herbs. Ziziphus jujuba var. spinosa is sweet and sour, moist in nature, and enters the heart and liver meridians. It nourishes blood and liver, calms the mind and soothes the nerves, directly targeting the main symptoms of "insomnia and excessive dreaming". Its effects of nourishing the heart and liver, calming the mind and reducing sweating dominate the whole formula, which is in line with the primary goal of "calming the mind and aiding sleep". Eucommia ulmoides tonifies the liver and kidneys and strengthens tendons and bones, directly improving the pathological basis of "liver and kidney deficiency". Together, they are the principal herbs. Codonopsis pilosula, Anemarrhena asphodeloides, and Ligusticum chuanxiong are the assistant herbs. Anemarrhena asphodeloides nourishes yin and reduces fire, clears deficiency heat to relieve bitter taste in the mouth and dry throat, and upward flaring of deficiency fire, and assists the principal herbs in relieving depression and irritability. Ligusticum chuanxiong invigorates blood and promotes qi circulation, soothes the liver and relieves depression, and alleviates symptoms of qi stagnation such as low mood and wiry and slippery pulse. Codonopsis pilosula tonifies qi and strengthens the spleen, targeting the symptoms of "weak body and spleen deficiency", enhancing the body's qi transformation function and assisting the principal herbs in calming the mind. Poria cocos is the adjuvant herb, which strengthens the spleen and calms the mind, promotes diuresis to remove greasy tongue coating, and works with the principal and assistant herbs to calm the mind, while also addressing spleen deficiency and dampness. Licorice is used as the guiding herb to harmonize the other herbs, mitigate their adverse effects, and simultaneously tonify the spleen and replenish qi, enhancing the overall synergistic effect of the formula. The entire formula uses jujube seed and eucommia bark as the chief herbs, anemarrhena rhizome, chuanxiong rhizome, and codonopsis root as the assistant herbs, poria cocos as the adjuvant herb, and licorice as the guiding herb. Together, they achieve the effects of calming the mind, tonifying, and harmonizing the body. It addresses symptoms of liver and kidney deficiency, mental disturbance due to deficiency fire, and disharmony between the heart and kidneys, with a clear hierarchy and orderly application of herbs.

[0036] The traditional Chinese medicine composition of the present invention is suitable for those who are physically weak and overthink, resulting in liver and kidney deficiency, upward flaring of deficiency fire, and disharmony between the heart and kidneys, with symptoms such as insomnia, dreaminess, low mood, restlessness, frequent sighing, dizziness, tinnitus, bitter taste in the mouth, dry throat, red tongue with greasy coating, and wiry and slippery pulse.

[0037] The beneficial effects of this invention are: 1) The composition prescription provided by this invention is selected based on the theory and clinical basis of traditional Chinese medicine dietary therapy. It uses pure natural raw materials and the formula is scientific and reasonable. The seven raw materials in the prescription are not simply superimposed. The effects of each herb complement each other. The saponins and flavonoids in jujube seed are the main components with sedative and hypnotic effects. These components can produce hypnotic effects and prolong sleep time through mechanisms such as regulating the serotonin system, resisting glutamate-mediated excitatory signaling pathways, and upregulating the expression of GABA receptors. Ligusticum chuanxiong has a significant sedative effect. Its volatile oil, when present in small amounts, has an inhibitory effect on the activity of the animal brain, while having an excitatory effect on the respiratory center, vasomotor center, and spinal reflex center of the medulla oblongata. Ligusticum chuanxiong contains abundant volatile oil and aromatic compounds. The ingredients can calm the nerves, soothe the mind, and improve sleep quality. Anemarrhena asphodeloides has the effects of clearing heat and purging fire, nourishing yin and moistening dryness. It can clear heat toxins from the body, reduce inflammatory response, and nourish the kidneys and replenish yin fluids, thus helping to improve sleep quality. Eucommia ulmoides contains components that can stimulate the pituitary-adrenal cortex system and enhance the function of the adrenal cortex, thereby achieving the effect of tonifying yang and kidneys. Poria cocos can nourish the heart and calm the mind, so it can be used for symptoms such as restlessness, palpitations, and insomnia. Licorice has a significant effect on experimental liver injury in animals, significantly reducing liver degeneration and necrosis, restoring most of the liver glycogen and ribonucleic acid content in hepatocytes to or near normal, and significantly reducing serum alanine aminotransferase activity, indicating that licorice has an anti-liver injury effect. Modern research shows that licorice extract can exert a sedative-hypnotic effect by influencing neurotransmitters such as the γ-aminobutyric acid (GABA) system. GABA is a major inhibitory neurotransmitter in the central nervous system, and licorice ethanol extract can increase GABA levels, thus aiding sleep. Codonopsis pilosula can be used to treat qi and blood deficiency syndrome and qi and yin deficiency syndrome. It has an improving effect on symptoms such as pale or sallow complexion, fatigue, dizziness, and palpitations caused by qi and blood deficiency, as well as mild thirst caused by qi and yin deficiency. Modern pharmacological research shows that Codonopsis pilosula can enhance the body's immunity. The above-mentioned raw materials are combined to exert a synergistic effect, greatly enhancing their effects of calming the mind and promoting sleep, tonifying qi and strengthening the spleen, nourishing blood and liver, and calming the mind and strengthening the kidneys. All the herbs in the formula are food ingredients or are permitted by the state for use in functional foods, and are safe and have no toxic side effects. 2) After administering the health supplements prepared in Examples 1-4 and Comparative Examples 1-3 at a dose of 10 g / kg to mice by gavage for 15 days, compared with the blank control group, the health supplements prepared in Examples 1-4 significantly prolonged the sleep time of mice treated with sodium pentobarbital for 15 days (P<0.01), and significantly shortened the sleep latency of mice treated with sodium pentobarbital for 15 days (P<0.05), without any direct sleep effect. Therefore, it is determined that the health supplements prepared in Examples 1-4 have the effect of helping to improve sleep function in mice. Detailed Implementation

[0038] It should be understood that, without departing from the principles of the present invention, several improvements and modifications can be made in conjunction with the following embodiments, and these improvements and modifications should also be considered within the scope of protection of the present invention. Example 1

[0039] Weigh the following raw materials in the indicated proportions: Eucommia ulmoides 64 parts, Ziziphus jujuba var. spinosa 26 parts, Codonopsis pilosula 48 parts, Anemarrhena asphodeloides 64 parts, Ligusticum chuanxiong 64 parts, Poria cocos 64 parts, and Glycyrrhiza uralensis 48 parts. Glycyrrhiza uralensis is a processed herb and should be added directly to the feed.

[0040] Prepare a traditional Chinese medicine composition or health product that helps improve sleep according to the following steps: Step (1): Raw material pretreatment: Remove impurities from the raw materials of Eucommia ulmoides, Ziziphus jujuba var. spinosa, Codonopsis pilosula, Anemarrhena asphodeloides, Ligusticum chuanxiong and Poria cocos. Cut Eucommia ulmoides and Codonopsis pilosula into 2-4cm sections, break the shell of Ziziphus jujuba var. spinosa, and crush Anemarrhena asphodeloides and Ligusticum chuanxiong into small pieces of about 2cm. Rinse the above 6 raw materials and set aside. Step (2): Extraction: Add water to the above six pre-treated raw materials and licorice and decoct twice. For the first decoction, add 6 times the amount of water as the raw materials, soak for 30 minutes, and decoct for 1.5 hours. For the second decoction, add 5 times the amount of water as the raw materials and decoct for 1 hour. Combine the decoctions and filter. Step (3): Concentration and drying: Concentrate under reduced pressure to a clear paste with a relative density of 1.10-1.15 at 60℃, spray dry with an inlet air temperature of 180℃ and an outlet air temperature of 95℃ to obtain spray-dried powder, pulverize and pass through a 100-mesh sieve for later use.

[0041] Step (4): Add 14 parts by weight of microcrystalline cellulose, 4 parts by weight of silicon dioxide and 4 parts by weight of magnesium stearate to the above spray-dried powder and mix for 30 minutes; Step (5): Fill capsules, 0.4g / capsule. Example 2

[0042] Weigh the following raw materials in the indicated proportions: Eucommia ulmoides 96 parts, Ziziphus jujuba var. spinosa 16 parts, Codonopsis pilosula 72 parts, Anemarrhena asphodeloides 96 parts, Ligusticum chuanxiong 32 parts, Poria cocos 96 parts, and Glycyrrhiza uralensis 72 parts. Glycyrrhiza uralensis is a processed herb and should be added directly to the feed.

[0043] The preparation method of the traditional Chinese medicine composition that helps improve sleep is the same as steps (1) to (3) in Example 1.

[0044] Preparation of health supplements that help improve sleep: Step (4): Add 18 parts by weight of microcrystalline cellulose, 5 parts by weight of silicon dioxide and 5 parts by weight of magnesium stearate to the above spray-dried powder and mix for 30 minutes; Step (5): Fill capsules, 0.4g / capsule. Example 3

[0045] Weigh the following raw materials in the indicated proportions: Eucommia ulmoides 41 parts, Ziziphus jujuba var. spinosa 39 parts, Codonopsis pilosula 64 parts, Anemarrhena asphodeloides 32 parts, Ligusticum chuanxiong 96 parts, Poria cocos 32 parts, and Glycyrrhiza uralensis 16 parts. Glycyrrhiza uralensis is a processed herb and is added directly to the feed.

[0046] The preparation method of the traditional Chinese medicine composition that helps improve sleep is the same as steps (1) to (3) in Example 1.

[0047] Preparation of health supplements that help improve sleep: Step (4): Add 12 parts by weight of microcrystalline cellulose, 3.5 parts by weight of silicon dioxide and 3.5 parts by weight of magnesium stearate to the above spray-dried powder, and mix for 30 minutes; Step (5): Fill capsules, 0.4g / capsule. Example 4

[0048] Weigh the following raw materials in the indicated proportions: 80 parts Eucommia ulmoides, 80 parts Ziziphus jujuba var. spinosa, 32 parts Codonopsis pilosula, 32 parts Anemarrhena asphodeloides, 32 parts Ligusticum chuanxiong, 32 parts Poria cocos, and 32 parts Glycyrrhiza uralensis. Glycyrrhiza uralensis is a processed herb and should be added directly to the feed.

[0049] The preparation method of the traditional Chinese medicine composition or health product that helps improve sleep is the same as in Example 3.

[0050] Comparative Example 1 Weigh the following raw materials in the indicated proportions: 26 parts of jujube seed, 64 parts of anemarrhena rhizome, 64 parts of chuanxiong rhizome, 64 parts of poria cocos, and 48 parts of licorice root. Licorice root is a processed herb and should be added directly to the ingredients.

[0051] Prepare traditional Chinese medicine compositions or health products according to the following steps: Step (1): Raw material pretreatment: Remove impurities from the raw materials of jujube seed, anemarrhena rhizome, chuanxiong rhizome and poria cocos. Crack the shell of jujube seed, and break anemarrhena rhizome and chuanxiong rhizome into small pieces of about 2cm. Rinse the above 4 raw materials and set aside. Step (2): Extraction: Add water to the above four pre-treated raw materials and licorice and decoct twice. For the first decoction, add 6 times the amount of water as the raw materials, soak for 30 minutes, and decoct for 1.5 hours. For the second decoction, add 5 times the amount of water as the raw materials and decoct for 1 hour. Combine the decoctions and filter. Step (3): Concentration and drying: Concentrate under reduced pressure to a clear paste with a relative density of 1.10-1.15 at 60℃, spray dry with an inlet air temperature of 180℃ and an outlet air temperature of 95℃ to obtain spray-dried powder, pulverize and pass through a 100-mesh sieve for later use.

[0052] Step (4): Add 14 parts by weight of microcrystalline cellulose, 4 parts by weight of silicon dioxide and 4 parts by weight of magnesium stearate to the above spray-dried powder and mix for 30 minutes; Step (5): Fill capsules, 0.4g / capsule.

[0053] Comparative Example 2 Weigh the following raw materials in the indicated proportions: 26 parts jujube seed, 48 parts codonopsis root, 64 parts chuanxiong rhizome, 64 parts poria cocos, and 48 parts licorice root. Licorice root is a processed herb and should be added directly to the ingredients.

[0054] Prepare a traditional Chinese medicine composition or health product that helps improve sleep according to the following steps: Step (1): Raw material pretreatment: Remove impurities from the raw materials of jujube seed, codonopsis, chuanxiong and poria. Cut codonopsis into 2-4cm small sections, crack the shell of jujube seed, and crush chuanxiong into small pieces of about 2cm. Rinse the above 4 raw materials and set aside. Step (2): Extraction: Add water to the above four pre-treated raw materials and licorice and decoct twice. For the first decoction, add 6 times the amount of water as the raw materials, soak for 30 minutes, and decoct for 1.5 hours. For the second decoction, add 5 times the amount of water as the raw materials and decoct for 1 hour. Combine the decoctions and filter. Step (3): Concentration and drying: Concentrate under reduced pressure to a clear paste with a relative density of 1.10-1.15 at 60℃, spray dry with an inlet air temperature of 180℃ and an outlet air temperature of 95℃ to obtain spray-dried powder, pulverize and pass through a 100-mesh sieve for later use.

[0055] Step (4): Add 14 parts by weight of microcrystalline cellulose, 4 parts by weight of silicon dioxide and 4 parts by weight of magnesium stearate to the above spray-dried powder and mix for 30 minutes; Step (5): Fill capsules, 0.4g / capsule.

[0056] Comparative Example 3 Weigh the following raw materials in the indicated proportions: 26 parts jujube seed, 48 parts codonopsis root, 64 parts anemarrhena rhizome, 64 parts poria cocos, and 48 parts licorice root. Licorice root is a processed herb and should be added directly to the ingredients.

[0057] Prepare a traditional Chinese medicine composition or health product that helps improve sleep according to the following steps: Step (1): Raw material pretreatment: Remove impurities from the raw materials of jujube seed, codonopsis, anemarrhena and poria. Cut codonopsis into 2-4cm small sections, crack the shell of jujube seed, and crush anemarrhena into small pieces of about 2cm. Rinse the above 4 raw materials and set aside. Step (2): Extraction: Add water to the above four pre-treated raw materials and licorice and decoct twice. For the first decoction, add 6 times the amount of water as the raw materials, soak for 30 minutes, and decoct for 1.5 hours. For the second decoction, add 5 times the amount of water as the raw materials and decoct for 1 hour. Combine the decoctions and filter. Step (3): Concentration and drying: Concentrate under reduced pressure to a clear paste with a relative density of 1.10-1.15 at 60℃, spray dry with an inlet air temperature of 180℃ and an outlet air temperature of 95℃ to obtain spray-dried powder, pulverize and pass through a 100-mesh sieve for later use.

[0058] Step (4): Add 14 parts by weight of microcrystalline cellulose, 4 parts by weight of silicon dioxide and 4 parts by weight of magnesium stearate to the above spray-dried powder and mix for 30 minutes; Step (5): Fill capsules, 0.4g / capsule. Application examples

[0059] This invention has a positive effect on improving sleep, which will be further illustrated below with animal experimental data, using the composition obtained in Example 1 as a sample.

[0060] 1. Laboratory animals Ninety Kunming mice were randomly divided into nine groups, with half males and half females in each group. The groups were: a blank control group (n=10), a positive control group (n=10), Example 1 group (n=10), Example 2 group (n=10), Example 3 group (n=10), Example 4 group (n=10), and Comparative Example 1 group (n=10), Comparative Example 2 group (n=10), and Comparative Example 3 group (n=10). The blank control group was administered 0.4 mL of distilled water by gavage, the positive control group was administered 1 mg / kg diazepam solution by gavage, and each example group and comparative example group was administered a dose of 10 g / kg.

[0061] 2. Sample The health products prepared in Examples 1 to 4 and Comparative Examples 1 to 3.

[0062] 3. Test Items 3.1 Direct Sleep Experiment Nine groups of mice were administered the drug via gavage once daily at the same time for 15 consecutive days. Mice were considered to be asleep if they could not turn over in a supine position for more than 60 seconds. The number of mice falling asleep in each group within one hour after the last gavage administration was recorded. A significant increase in the number of sleeping mice was considered a positive result.

[0063] Results of direct sleep experiment in mice Group Animal number Number of animals falling asleep Sleep incidence rate % Blank control group 10 0 0 Positive control group 10 8 80 Example 1 Group 10 0 0 Example 2 group 10 0 0 Example 3 Group 10 0 0 Example 4 group 10 0 0 Comparative Example 1 10 0 0 Comparative Example 2 10 0 0 Comparative Example 3 Groups 10 0 0 Results: Except for the positive control group, which had a sleep rate of 80%, significantly higher than the blank control group, the other example groups and comparative groups did not improve the sleep rate of mice.

[0064] 3.2 Experiment on prolonging sodium pentobarbital sleep time Experiment: Thirty minutes after the last gavage, mice were intraperitoneally injected with sodium pentobarbital 45 mg / kg. The experiment observed whether the test substance could prolong the sleep time of the mice and the differences in sleep time among the groups. The sleep time was recorded as the time from the disappearance to the reappearance of the righting reflex. A significant prolongation of sleep time was considered a positive result.

[0065] Results of experiments prolonging sodium pentobarbital sleep time Group Animal number Number of animals falling asleep Sleep incidence rate % Sleep duration (min) Blank control group 10 10 100 27.31±9.53 Positive control group 10 10 100 72.55±15.11** Example 1 Group 10 10 100 40.26±10.52** Example 2 group 10 10 100 45.26±15.68** Example 3 Group 10 10 100 36.38±8.91** Example 4 group 10 10 100 47.18±12.10** Comparative Example 1 10 10 100 29.68±11.82 Comparative Example 2 10 10 100 31.23±10.74 Comparative Example 3 Groups 10 10 100 33.07±7.37 **: P < 0.01, compared with the blank control group Results: Compared with the blank control group, the positive control group and the example group showed significant differences, with significantly prolonged sleep time. Although the sleep time of the comparative proportion group was slightly prolonged, there was no significant difference compared with the blank control group.

[0066] 3.3 Subthreshold dose hypnotic experiment with sodium pentobarbital Thirty minutes after the last gavage, mice were intraperitoneally injected with sodium pentobarbital 25 mg / kg. Sleep was defined as a mouse remaining in a supine position for more than 60 seconds without being able to right itself. Differences in sleep time among the groups were observed. A significant increase in the incidence of sleepiness was considered a positive result.

[0067] Results of subthreshold dose hypnotic experiments with sodium pentobarbital Group Animal number Number of animals falling asleep Sleep incidence rate % Blank control group 10 1 10 Positive control group 10 9 90 Example 1 Group 10 4 40 Example 2 group 10 5 50 Example 3 Group 10 3 30 Example 4 group 10 4 40 Comparative Example 1 10 2 20 Comparative Example 2 10 2 20 Comparative Example 3 Groups 10 2 20 Results: The sleep rate of mice in the control group was 10%, which validated the rationality of using sodium pentobarbital dosage to study the effect of subthreshold sodium on mouse hypnosis. Compared with the control group, the sleep rates of mice in the example groups were 40%, 50%, 30%, and 40%, respectively, all showing varying degrees of improvement. The sleep rate of mice in the control group was 20% for all mice. The example groups showed a better hypnotic effect of subthreshold sodium pentobarbital on mice than the control group.

[0068] 3.4 Sodium barbital sleep latency test Thirty minutes after the last gavage, mice were intraperitoneally injected with sodium barbital 250 mg / kg. A mouse was considered to have entered a sleep state if it could not right itself for more than 60 seconds while in a supine position. The time from intraperitoneal injection to the disappearance of the righting reflex was recorded as the sleep latency. Differences in sleep latency among the groups were observed. A significant shortening of sleep latency was considered a positive result.

[0069] Results of sodium barbital sleep latency test Group Animal number Number of animals falling asleep Sleep incidence rate % Sleep latency (min) Blank control group 10 10 100 23.81±3.57 Positive control group 10 10 100 12.19±2.44** Example 1 Group 10 10 100 18.66±5.32* Example 2 group 10 10 100 17.36±4.86* Example 3 Group 10 10 100 19.18±5.29* Example 4 group 10 10 100 17.22±7.17* Comparative Example 1 10 10 100 22.53±2.09 Comparative Example 2 10 10 100 23.92±5.97 Comparative Example 3 Groups 10 10 100 21.01±7.82 **: P < 0.01, *: P < 0.05, compared with the blank control group Results: Compared with the blank control group, all example groups showed significant differences, with shortened sleep latency. The sleep latency of the comparative proportion group was not significantly different from that of the blank control group.

[0070] 4. Result Determination If any two of the three tests—the prolonged sleep time test, the subthreshold dose hypnotic test of sodium pentobarbital (or sodium barbital), and the sleep latency test of sodium barbital—are positive, and there is no obvious direct sleep effect, the test sample can be determined to have the effect of improving sleep.

[0071] 5. Experimental Conclusions After administering the health supplements prepared in Examples 1-4 and Comparative Examples 1-3 at a dose of 10 g / kg to mice by gavage for 15 days, compared with the blank control group, the health supplements prepared in Examples 1-4 significantly prolonged the sleep time of mice treated with sodium pentobarbital for 15 days (P<0.01), and significantly shortened the sleep latency of mice treated with sodium pentobarbital for 15 days (P<0.05), without any direct sleep effect. Therefore, it is determined that the health supplements prepared in Examples 1-4 have the effect of helping to improve sleep function in mice.

Claims

1. A traditional Chinese medicine composition that helps improve sleep, characterized in that, The ingredients include the following parts by weight: Eucommia ulmoides 10-96 parts, Ziziphus jujuba var. spinosa 5-80 parts, Codonopsis pilosula 5-72 parts, Anemarrhena asphodeloides 10-96 parts, Ligusticum chuanxiong 10-96 parts, Poria cocos 10-96 parts, and Glycyrrhiza uralensis 5-72 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: Eucommia ulmoides 32-96 parts, Ziziphus jujuba var. spinosa 13-80 parts, Codonopsis pilosula 32-72 parts, Anemarrhena asphodeloides 32-96 parts, Ligusticum chuanxiong 32-96 parts, Poria cocos 32-96 parts, and Glycyrrhiza uralensis 16-72 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, Its composition is as follows: 64 parts Eucommia ulmoides, 26 parts Ziziphus jujuba var. spinosa, 48 parts Codonopsis pilosula, 64 parts Anemarrhena asphodeloides, 64 parts Ligusticum chuanxiong, 64 parts Poria cocos, and 48 parts Glycyrrhiza uralensis.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The preparation method of the traditional Chinese medicine composition that helps improve sleep includes the following steps: Step (1): Extraction: Eucommia ulmoides, Ziziphus jujuba var. spinosa, Codonopsis pilosula, Anemarrhena asphodeloides, Ligusticum chuanxiong, Poria cocos and Glycyrrhiza uralensis are extracted by traditional hot water reflux extraction method. The extraction time is 0.5-2.0 hours, the number of extractions is 1-3 times, and the amount of water used each time is 5-8 times that of the raw material; Step (2): Concentration and drying: The extract is concentrated to a clear paste with a relative density of 1.10-1.15 at 60℃, spray dried, the inlet air temperature is 160-200℃, the outlet air temperature is 90-100℃, and spray dried powder is obtained.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The extraction in step (1) is performed twice. The amount of water used in the first extraction is 6 times that of the raw material, and the extraction time is 1.5 hours. The amount of water used in the second extraction is 5 times that of the raw material, and the extraction time is 1 hour.

6. The traditional Chinese medicine composition according to claim 4, characterized in that, The concentration and drying temperature in step (2) is 70-80℃.

7. The traditional Chinese medicine composition according to claim 4, characterized in that, It also includes pulverization: spray-dried powder is pulverized through a 100-mesh sieve.

8. A health product comprising the above-mentioned traditional Chinese medicine composition that helps improve sleep and excipients.

9. The health product according to claim 8, characterized in that, The excipients include any one or a combination of at least two of corn starch, microcrystalline cellulose, silicon dioxide, or magnesium stearate.

10. The health product according to claim 8, characterized in that, The health product is in capsule form.