CN112587646A

CN112587646A - Traditional Chinese medicine composition for aiding sleep

Info

Publication number: CN112587646A
Application number: CN202110032699.XA
Authority: CN
Inventors: 白云昇; 谢瑶; 刘静; 路子佳
Original assignee: BEIJING DAWN AEROSPACE BIO-TECH CO LTD
Current assignee: BEIJING DAWN AEROSPACE BIO-TECH CO LTD
Priority date: 2021-01-11
Filing date: 2021-01-11
Publication date: 2021-04-02

Abstract

The embodiment of the invention provides a traditional Chinese medicine composition for aiding sleep, which comprises the following main raw materials in percentage by mass: 24 to 27 percent of spina date seed extract, 9 to 11 percent of lucid ganoderma extract, 8.3 to 10 percent of schisandra extract, 4 to 5 percent of gamma-aminobutyric acid, 2.5 to 4.5 percent of theanine of tea leaves, 1.2 to 1.8 percent of melissa officinalis, 0.3 to 0.7 percent of passion flower extract, 27.5 to 29 percent of red yeast rice, 9.2 to 11 percent of green tea extract and 6 to 8 percent of black ginger extract. The embodiment of the invention provides a traditional Chinese medicine composition for assisting sleep, which starts from the research of a sleep-wake regulation mechanism from the receptor angle, starts from GABA regulation and control branches to regulate sleep, is assisted by traditional Chinese medicinal materials, and assists in regulating the operation of functions of various internal organs of a body from the traditional Chinese medicine theory angle to ensure that the operation of yin and yang qi of a human body is normal, thereby further regulating the sleep of the human body.

Description

Traditional Chinese medicine composition for aiding sleep

Technical Field

The invention relates to the technical field of traditional Chinese medicine health care, in particular to a traditional Chinese medicine composition for aiding sleep.

Background

With the social development, the pace of life is accelerated, night life is increased, the sleep time is shortened, the sleep quality is reduced due to various sleep diseases such as insomnia and snoring, and the sleep quality of people is worsened due to a plurality of factors such as further enhancement of work and employment pressure of people and competition pressure in various fields. Insufficient sleep can lead to memory loss and decreased brain function. The energy and oxygen in the brain nerve cells are greatly consumed in working and learning in the daytime, and the brain nerve cells can be in a rest state by enough sleep, so that the energy and the oxygen are supplemented, the memory is enhanced, the brain function is recovered, and the fatigue is eliminated. At present, medicines (western medicines) are mostly used for solving the sleep problem in the market, however, the traditional medicines for treating insomnia by using the western medicines, such as barbiturates, benzodiazepines and the like, are often accompanied by large side effects after being taken, such as hangover, addiction, rebound after stopping taking the medicines and the like. The traditional Chinese medicine has the advantages that western medicines do not exist, namely, the traditional Chinese medicine is not addicted and does not generate dependence, and people can be helped to realize natural and healthy sleep. Therefore, there is an urgent need for a Chinese medicinal product which has no side effects and can improve sleep quality.

Disclosure of Invention

The embodiment of the invention provides a traditional Chinese medicine composition for aiding sleep, which overcomes the defects of the prior art.

In order to achieve the purpose, the invention adopts the following technical scheme.

A traditional Chinese medicine composition for aiding sleep comprises the following main raw materials in percentage by mass: 24 to 27 percent of spina date seed extract, 9 to 11 percent of lucid ganoderma extract, 8.3 to 10 percent of schisandra extract, 4 to 5 percent of gamma-aminobutyric acid, 2.5 to 4.5 percent of theanine of tea leaves, 1.2 to 1.8 percent of melissa officinalis, 0.3 to 0.7 percent of passion flower extract, 27.5 to 29 percent of red yeast rice, 9.2 to 11 percent of green tea extract and 6 to 8 percent of black ginger extract.

Preferably, the content of total saponins in the spina date seed extract is more than or equal to 2%, the content of crude polysaccharide in the lucid ganoderma extract is more than or equal to 10%, the content of schizandrol A in the schisandra chinensis extract is more than or equal to 1.0%, and flavone in the passionflower extract calculated by vitexin is more than or equal to 4%.

Preferably, the wild jujube seed extract is 27%, the ganoderma lucidum extract is 9%, the schisandra chinensis extract is 8.3%, the gamma-aminobutyric acid is 5%, the theanine of tea is 4.5%, the melissa officinalis is 1.2%, the passion flower extract is 0.3%, the red yeast rice is 27.5%, the green tea extract is 9.2%, and the black ginger extract is 8%.

Preferably, the wild jujube seed extract is 24%, the ganoderma lucidum extract is 11%, the schisandra chinensis extract is 10%, the gamma-aminobutyric acid is 4%, the tea theanine is 2.5%, the melissa officinalis is 1.8%, the passion flower extract is 0.7%, the red yeast rice is 29%, the green tea extract is 11%, and the black ginger extract is 6%.

Preferably, the wild jujube seed extract is 25.75%, the ganoderma lucidum extract is 10.3%, the schisandra chinensis extract is 9.16%, the gamma-aminobutyric acid is 4.29%, the tea theanine is 2.86%, the melissa officinalis is 1.43%, the passion flower extract is 0.43%, the red yeast rice is 28.61%, the green tea extract is 10.3%, and the black ginger extract is 6.87%.

Preferably, the composition further comprises an auxiliary material, wherein the auxiliary material is one or more of isomalt, erythritol, microcrystalline cellulose and magnesium stearate;

when the composition contains isomalt, the isomalt accounts for 18-21% of the main raw material by mass;

when the composition contains erythritol, the erythritol accounts for 2.7-3% of the main raw material by mass;

when the composition contains microcrystalline cellulose, the mass percent of the microcrystalline cellulose in the main raw material is 2.5% -2.8%;

when the composition contains magnesium stearate, the magnesium stearate accounts for 0.5-0.65% of the main raw material by mass.

Preferably, the isomalt accounts for 19.69% of the main raw material by mass, the erythritol accounts for 2.86% of the main raw material by mass, the microcrystalline cellulose accounts for 2.63% of the main raw material by mass, and the magnesium stearate accounts for 0.57% of the main raw material by mass.

The embodiment of the invention provides a traditional Chinese medicine composition for aiding sleep, which has the following pharmacological actions:

1) wild jujube seed

Semen Ziziphi Spinosae is seed of Rhamnaceae plant fructus Ziziphi Spinosae, and semen Ziziphi Spinosae saponin A, B and flavonoid compounds in semen Ziziphi Spinosae are main effective components, and have tranquilizing and hypnotic effects. The spina date seed also has remarkable effects of reducing blood fat and resisting platelet aggregation; has effects in resisting myocardial ischemia and lipid peroxidation in rat. Animal experiments prove that the spina date seed can inhibit the central nervous system, has the effects of tranquilizing and hypnotizing and has no toxic reaction. The results of experiments on animals and human bodies show that the effects and the curative effects of the animals and the human bodies are completely the same, and the animals and the human bodies have no difference and no opposite effect of inducing awakening.

2) Schisandra chinensis

Fructus Schisandrae is fruit of Schisandra chinensis of Magnoliaceae. The pericarp and mature seed coat contain lignans, which are the effective medicinal components of fructus Schisandrae, including various schizandrin. Has obvious effects on central nervous system, and has effects of tranquilizing, invigorating qi, promoting fluid production, and treating cough, asthma, body fluid deficiency, xerostomia, spermatorrhea, chronic diarrhea, amnesia, insomnia, etc. Pharmacological tests prove that the Chinese medicinal composition can regulate the excitation and inhibition processes of the central nervous system, promote the metabolism of the human body, and has the effects of astringing, arresting discharge, tonifying qi, promoting the production of body fluid, tonifying the kidney and calming the heart. The Chinese medicinal composition is clinically applied to chronic cough and asthenic asthma, nocturnal emission, enuresis, frequent micturition, chronic diarrhea, spontaneous perspiration, night sweat, regular injury, thirst, palpitation and insomnia.

3) Glossy ganoderma

Ganoderma is whole plant of Ganoderma lucidum or Ganoderma sinense of Polyporaceae. Ganoderma lucidum has high medicinal value as a traditional Chinese treasure medicinal material with thousands of years of medicinal history, and the ancient China believes that the Ganoderma lucidum has the effects of being old and dead and reviving and is regarded as the Mesona chinensis. Modern pharmacological research of scientific research institutions for decades proves that the ganoderma lucidum has obvious curative effects on enhancing human immunity, regulating blood sugar, controlling blood pressure, assisting tumor radiotherapy and chemotherapy, protecting liver, promoting sleep and the like. The pharmacological actions of ganoderma lucidum are recognized and acknowledged internationally in many countries. In the future popularization process, the lucid ganoderma needs to obtain more cognition and application of people, and contributes to human health. Animal pharmacology shows that the experiment: ganoderma has effects of inhibiting nervous system, lowering blood pressure and strengthening heart contraction, and eliminating phlegm for respiratory system. Ganoderma lucidum has been used for neurasthenia and insomnia, and it has a good effect on the central nervous system. The extract can stimulate motility inhibition, reduce motility, cause coordinated movement disorder and show dosage-dependent disease-relieving effect, has effect in shortening sleep time for Cyclohexabarbital, and can prolong spasm and death time caused by central stimulant caffeine, and these results show that Ganoderma has inhibitory effect on central nervous system. The ganoderma lucidum has a strong regulating effect on the central nervous system, has the efficacy of tranquilizing and allaying excitement, is an essential good product for patients with neurasthenia and insomnia, and is an effective medicine for improving sleep and tranquilizing in the national formulary.

4) Gamma-aminobutyric acid

Gamma-aminobutyric acid (GABA) is a four-carbon nonprotein amino acid, is an important inhibitory neurotransmitter in the central nervous system of mammals and plays an important role in sleep. It can bind to and activate anxiolytic brain receptors, and then act synergistically with other substances to prevent anxiety-related information from reaching brain indicating center, thereby promoting relaxation and eliminating nervous tension, so as to achieve anti-stress and anxiolytic effects. The gamma-aminobutyric acid can rest the excited brain cells, inhibit the excessive excitation of nerve cells and achieve the effect of improving sleep. It is also called "natural sedative for the brain" because it can induce the brain to calm down.

GABA is a central nervous system inhibitory neurotransmitter, and can be catabolized via GABA bypass (GABA-shunt) under the action of GABA transaminase, and gamma-hydroxybutyric acid (GHB), an intermediate metabolite thereof, can exert inhibitory action on central nervous system excitatory neurons through the action of GHB specific receptors on cell membranes, GABA-B receptors or 5-hydroxytryptamine nervous systems and the like, thereby producing sedative and hypnotic effects on organisms.

The gamma-aminobutyric acid can promote the metabolism of brain tissues, recover the functions of brain cells and improve the nerve functions. It can enter into tricarboxylic acid circulation in brain to promote brain cell metabolism, raise glucose phosphatase activity during glucose metabolism, increase acetylcholine formation, dilate blood vessel, increase blood flow, make brain cell active and raise brain activity.

5) Theanine

Theanine is a unique amino acid found primarily in plants of the family Theaceae and typically constitutes 1-2% of the total weight of dry matter of tea. The theanine existing in nature is L-type, and is systematically named as: N-ethyl-L-glutamine, is very soluble in water. L-theanine can be absorbed through the small intestine wall, can pass through the blood brain barrier after a human body takes L-theanine for 30min, reaches the peak value of the L-theanine content in the brain after 5h, can influence the function of a central system through various mechanisms, and is metabolized in the spleen to generate ethylamine and glutamine.

6) Melissa officinalis

Melissa is also a species of mint, a traditional herb widely used as a mild sedative, spasmolytic, antibacterial agent. Animal experiments show that vanillin and citral are the main active components of Melissa officinalis with sedative and hypnotic effects. In addition, rosmarinic acid, ursolic acid and oleanolic acid in Melissa officinalis can inhibit GABA transaminase of brain tissue of rat, thereby interfering GABA metabolism, increasing GABA content in brain, reducing excitability of nervous system, tranquilizing, relieving and resisting anxiety.

Melissa extract also has a function of improving psychological mood and cognitive ability, and it is currently believed that these mechanisms are associated with muscarinic receptors and nicotinic acetylcholine receptors. The Melissa officinalis extract has acetylcholinesterase (AChE) inhibiting activity, and the acetylcholinesterase inhibitor can inhibit the activity of cholinesterase in synaptic cleft to reduce acetylcholine decomposition, thereby increasing acetylcholine activity to realize neuroprotection; melissa officinalis extract also has protective effect on methylenedioxymethamphetamine (MDMA) induced apoptosis of hippocampal primary neuronal cells.

7) Passion flower extract

In recent years, foreign research on the health care function of passion flower shows that the passion flower plant has the health care effects of resisting anxiety and calming and sleeping. The duration of sleep was significantly prolonged in mice in the ether-induced hypnotic test after addition of the water extract of passion fruit peel. The passion flower extract enhances the affinity to GABA receptors and inhibits the reuptake of rat cortical synaptosomes to GABA; direct GABA A current is induced in CA1 hippocampal pyramidal neurons, and the current has the function similar to benzodiazepine drugs.

8) Red rice

Red rice has effects of lowering blood pressure, reducing blood lipid, and reducing cholesterol, and the contained lovastatin can effectively prevent triglyceride formation. It also has effects in invigorating spleen, promoting digestion, promoting blood circulation, removing blood stasis, and has good adjuvant treatment effect on cardiovascular and cerebrovascular diseases, chest distress, headache, and abdominal distention.

9) Green tea extract

The green tea extract is an active component extracted from green tea leaves, mainly comprises tea polyphenol which has the effects of resisting oxidation, eliminating free radicals and the like, obviously reduces the content of serum total cholesterol, triglyceride and low-density lipoprotein cholesterol of hyperlipidaemia, simultaneously has the effects of recovering and protecting the function of vascular endothelium, improves the overall immunity of a human body and can promote the self-conditioning function of the human body.

10) Black ginger extract

The black ginger can be made into tea and various foods in folk, and is used for improving blood flow and enhancing vitality. Polymethoxylated flavones (PMFs) in the extract of Zingiber nigrum L have high activity on SIRT1 enzyme (deacetylase), and can activate SIRT1 enzyme. The SIRT1 enzyme can delay the onset of diseases caused by aging, such as diabetes, dementia, obesity, motor dysfunction and prolong the health span of human beings. The activation effect of the black ginger extract (100ug/mL) on the SIRT1 enzyme is 5 times that of resveratrol.

According to the technical scheme provided by the embodiment of the invention, the sleep-aiding traditional Chinese medicine composition is composed of traditional Chinese medicines such as a spina date seed extract, a lucid ganoderma extract, a schisandra chinensis extract, gamma-aminobutyric acid, tea theanine, melissa officinalis, a passion flower extract, red yeast rice, a green tea extract and a black ginger extract, and has the functions of soothing the nerves, aiding sleep, regulating blood pressure, enhancing human immunity and the like. The invention starts from the research of a sleep-wake regulation mechanism from the receptor perspective, starts from the GABA regulation branch to regulate the sleep, simultaneously assists with traditional Chinese medicinal materials, and assists in regulating the operation of the functions of various viscera of a human body from the traditional Chinese medicine theory perspective, so that the operation of yin and yang qi of the human body is normal, the sleep of the human body is further regulated, the sleep improvement effect is obvious, the safety is high, and no side effect exists; the red yeast, the green tea extract and the black ginger extract have the effects of being beneficial to regulating blood index levels such as blood fat, blood sugar and the like, can effectively improve the blood health condition of organisms, and increase the blood and nutrient supply capacity, thereby assisting in improving the sleep condition of the organisms; in addition, the melissa officinalis and the passion flower extract act on different aspects of GABA paths in GABA branches, so that the GABA content and the receptor affinity in a human body can be improved, a synergistic effect is achieved, and the dosage of gamma-aminobutyric acid in the composition can be reduced to a certain extent, so that the production cost is reduced.

Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.

Detailed Description

In order to facilitate understanding of the embodiments of the present invention, the following description will be made by taking several specific embodiments as examples, and the embodiments are not to be construed as limiting the embodiments of the present invention.

The embodiment of the invention provides a traditional Chinese medicine composition for aiding sleep, which comprises the following main raw materials in percentage by mass: 24 to 27 percent of spina date seed extract, 9 to 11 percent of lucid ganoderma extract, 8.3 to 10 percent of schisandra extract, 4 to 5 percent of gamma-aminobutyric acid, 2.5 to 4.5 percent of theanine of tea leaves, 1.2 to 1.8 percent of melissa officinalis, 0.3 to 0.7 percent of passion flower extract, 27.5 to 29 percent of red yeast rice, 9.2 to 11 percent of green tea extract and 6 to 8 percent of black ginger extract.

Wherein, the content of total saponins in the wild jujube seed extract is more than or equal to 2 percent, the content of crude polysaccharide in the lucid ganoderma extract is more than or equal to 10 percent, the content of schizandrol A in the schisandra chinensis extract is more than or equal to 1.0 percent, and the content of flavone in the passionflower extract calculated by vitexin is more than or equal to 4 percent.

The composition also comprises an auxiliary material, wherein the auxiliary material is one or more of isomalt, erythritol, microcrystalline cellulose and magnesium stearate. When the composition contains isomalt, the isomalt accounts for 18-21% of the main raw material by mass, and is preferably 19.69%; when the composition contains erythritol, the erythritol accounts for 2.7-3% of the main raw material by mass, and preferably 2.86%; when the composition contains microcrystalline cellulose, the mass percent of the microcrystalline cellulose in the main raw material is 2.5-2.8%, preferably 2.63%; when the composition contains magnesium stearate, the mass percentage of the magnesium stearate in the main raw material is 0.5-0.65%, and preferably 0.57%.

According to the technical scheme, the GABA regulating branch is used for regulating the sleep, and the traditional Chinese medicine theory is combined with the traditional Chinese medicine theory and the traditional Chinese medicinal materials such as the spina date seed extract, the lucid ganoderma extract and the schisandra chinensis extract are used as auxiliary materials, so that the sleep of a human body is further regulated, and the sleep improving effect is obvious. The melissa officinalis and passion flower extract act on different aspects of GABA paths in GABA branches, can improve GABA content and receptor affinity in a human body, has a synergistic effect, and can reduce the dosage of gamma-aminobutyric acid in the composition to a certain extent, so that the production cost is reduced. In addition, the red yeast rice can generate a plurality of metabolites beneficial to human beings, and the red yeast rice and other medicinal materials in the composition supplement each other in action, so that the composition has a synergistic effect, and can effectively relieve emotion and improve sleep; green tea extract can improve cerebral cortex activity and regulate blood lipid metabolism; the extract of Zingiber Officinale Rosc has effects in improving sugar and lipid metabolism, inhibiting fat tissue hypertrophy, promoting muscle cell differentiation, improving blood vessel aging and blood flow, enhancing activity, and resisting saccharification and oxidation. The extract and the raw material composition have simple components, no side effect on human bodies and safety.

The embodiment of the invention provides a specific preparation process of a traditional Chinese medicine composition for aiding sleep, which is a known technology in the art, and is not described in detail in this embodiment and other embodiments.

In order to further explain the invention, the following describes the sleep-aiding Chinese medicinal composition provided by the invention in detail with reference to the examples.

Example one

In the embodiment of the invention, the traditional Chinese medicine composition for aiding sleep comprises the following main raw materials in percentage by mass: 27% of spina date seed extract, 9% of lucid ganoderma extract, 8.3% of schisandra extract, 5% of gamma-aminobutyric acid, 4.5% of theanine, 1.2% of melissa officinalis, 0.3% of passion flower extract, 27.5% of red yeast rice, 9.2% of green tea extract and 8% of black ginger extract. Wherein, the content of total saponins in the wild jujube seed extract is more than or equal to 2 percent, the content of crude polysaccharide in the lucid ganoderma extract is more than or equal to 10 percent, the content of schizandrol A in the schisandra chinensis extract is more than or equal to 1.0 percent, and the content of flavone in the passionflower extract calculated by vitexin is more than or equal to 4 percent.

The auxiliary materials in the composition are isomalt, erythritol, microcrystalline cellulose and magnesium stearate, wherein the isomalt accounts for 19.69% of the main raw material by mass, the erythritol accounts for 2.86% of the main raw material by mass, the microcrystalline cellulose accounts for 2.63% of the main raw material by mass, and the magnesium stearate accounts for 0.57% of the main raw material by mass.

Example two

In the embodiment of the invention, the traditional Chinese medicine composition for aiding sleep comprises the following main raw materials in percentage by mass: 24% of spina date seed extract, 11% of lucid ganoderma extract, 10% of schisandra extract, 4% of gamma-aminobutyric acid, 2.5% of theanine, 1.8% of melissa officinalis, 0.7% of passion flower extract, 29% of red yeast rice, 11% of green tea extract and 6% of black ginger extract. Wherein, the content of total saponins in the wild jujube seed extract is more than or equal to 2 percent, the content of crude polysaccharide in the lucid ganoderma extract is more than or equal to 10 percent, the content of schizandrol A in the schisandra chinensis extract is more than or equal to 1.0 percent, and the content of flavone in the passionflower extract calculated by vitexin is more than or equal to 4 percent.

EXAMPLE III

In the embodiment of the invention, the traditional Chinese medicine composition for aiding sleep comprises the following main raw materials in percentage by mass: 25.75% of spina date seed extract, 10.3% of lucid ganoderma extract, 9.16% of schisandra extract, 4.29% of gamma-aminobutyric acid, 2.86% of theanine, 1.43% of melissa officinalis, 0.43% of passion flower extract, 28.61% of red yeast rice, 10.3% of green tea extract and 6.87% of black ginger extract. Wherein, the content of total saponins in the wild jujube seed extract is more than or equal to 2 percent, the content of crude polysaccharide in the lucid ganoderma extract is more than or equal to 10 percent, the content of schizandrol A in the schisandra chinensis extract is more than or equal to 1.0 percent, and the content of flavone in the passionflower extract calculated by vitexin is more than or equal to 4 percent.

Example four

In the embodiment of the invention, the traditional Chinese medicine composition for aiding sleep comprises the following main raw materials: 225g of spina date seed extract, 90g of lucid ganoderma extract, 80g of schisandra chinensis extract, 37.5g of gamma-aminobutyric acid, 25g of theanine, 12.5g of melissa officinalis, 3.75g of passion flower extract, 250g of red yeast rice, 90g of green tea extract and 60g of black ginger extract. Wherein, the content of total saponins in the wild jujube seed extract is more than or equal to 2 percent, the content of crude polysaccharide in the lucid ganoderma extract is more than or equal to 10 percent, the content of schizandrol A in the schisandra chinensis extract is more than or equal to 1.0 percent, and the content of flavone in the passionflower extract calculated by vitexin is more than or equal to 4 percent.

The auxiliary materials comprise: 172g of isomalt, 25g of erythritol, 23g of microcrystalline cellulose and 5g of magnesium stearate.

EXAMPLE five

Animal experiments were carried out using the composition prepared in any of examples 1 to 4 above:

1. materials and methods

1.1 sample: tablet, size: 0.5 g/tablet, 2 tablets per person (adult) per day, wherein the recommended dosage for oral administration is 33.3mg/kg BW, and the weight of the adult is calculated according to 60 kg.

1.2 Experimental animals and groups: 120 SPF-grade healthy adult Kunming male mice bred in Guangdong province medical test animal center are selected, and the weight of the mice is 18-22 g. Every 40 mice are divided into one group, and 3 groups are respectively subjected to a direct sleep test, a test for prolonging the sleep time of pentobarbital sodium and a test for sleep latency of barbital sodium.

1.3 environmental conditions of experimental animal houses: animal laboratories are barrier systems. Laboratory temperature of the laboratory: 22-25 ℃, relative humidity: 55-77%.

1.4 dose selection and sample treatment: based on the recommended human dose for this sample, there were 3 test groups of 167, 333, 666mg/kg BW (corresponding to 5, 10, 20 times the recommended human dose), and one negative control group of 10 animals per group. Respectively weighing 835 mg, 1665 mg and 3330mg of the composition tablets, adding pure water to 100mL, mixing uniformly, preparing 8.35 mg/mL, 16.65 mg/mL and 33.30mg/mL concentration solutions, respectively feeding corresponding dose groups of animals with the gavage volume of 0.2mL/10g BW, feeding the control group with the pure water with the same volume, gavage once a day, and continuously gavage for 30 days.

1.5 Main instruments and reagents

The instrument comprises the following steps: animal platform scales, electronic analytical balances, stopwatches, and the like.

Reagent: pentobarbital sodium (imported and packaged by Shanghai West Biotech Co., Ltd.), and barbital sodium (produced by Guangfu Fine chemical research institute of Tianjin).

1.6 Experimental methods

1.6.1 direct sleep test: and (3) observing the sleep condition of the mouse after the last sample is given, judging that the mouse enters the sleep by taking the disappearance of the righting reflex of the animal for more than 60 seconds, and judging that the animal is awakened by the restoration of the righting reflex. Experimental results the number of animals falling asleep was measured as x²Testing, and statistically analyzing the sleep time by using analysis of variance. If the number of the animals falling asleep or the sleep time of the test group is increased and has a significant difference with the negative control group, the test result is judged to be positive.

1.6.2 test for prolonging the sleep time of sodium pentobarbital: after 20 minutes of administration of the last sample, animals were injected intraperitoneally with 45mg/kg BW of sodium pentobarbital in an amount of 0.2mL/20g BW. And observing whether the test object can prolong the sleep time of the sodium pentobarbital by taking the disappearance of the righting reflex of the animal as an index. The experimental results were statistically analyzed by analysis of variance. If the sleeping time of the test group mouse is longer than that of the negative control group and has statistical significance, the test result is judged to be positive.

1.6.3 barbiturate sodium sleep latency test: each group of animals was injected with 300mg/kg BW of barbital sodium intraperitoneally 20 minutes after the last sample administration, and the injection amount was 0.2mL/20g BW. And observing whether the test object can shorten the sleep latency of the barbiturate sodium by taking the disappearance of the righting reflex as an index. The experimental results were statistically analyzed by analysis of variance. If the sleep latency of the test group mice is shorter than that of the negative control group and has statistical significance, the test result is judged to be positive.

1.7 determination of results

If the test for prolonging the sleep time of the sodium pentobarbital and the test for prolonging the sleep latency of the sodium barbital are positive and have no obvious direct sleep effect, the test sample can be judged to have the effect of improving the sleep function.

2. Results

2.1 Effect of samples on mouse body weight

TABLE 1 weight of experimental mice for improving sleep function

Note: in the sleep I-III groups, the initial, middle and terminal body weights and weight gains of mice in each dose group are compared with those in a negative control group, and the differences are not significant (P is more than 0.05).

As can be seen from Table 1, the body weights of the mice in each dose group of the samples at the initial stage, the middle stage and the final stage of the experiment and the body weight increase of the mice in the experiment period are compared with those of the negative control group, and the differences are not significant (P is more than 0.05), which indicates that the sample has no obvious influence on the body weight increase of the mice.

2.2 direct sleep Effect of samples

As can be seen from table 2, when the composition of the present invention is orally administered to mice at different doses for 30 days, no animal appears to have the disappearance of righting reflex in each dose group, i.e. all animals do not enter a sleep state, and the sample is promoted not to have the effect of directly inducing the sleep of the mice.

TABLE 2 direct sleep test results in mice

2.3 Effect of samples on sleep time of sodium pentobarbital

TABLE 3 Experimental results for prolonging the sleep time of sodium pentobarbital

As can be seen from table 3, when the composition of the present invention is orally administered to mice at different doses for 30 days, the sleep time of each dose group is longer than that of the negative control group, and the difference between the high and medium dose groups and the negative control group is significant (P <0.01 and P <0.05, respectively), indicating that the sample has the effect of prolonging the sleep time of sodium pentobarbital.

2.4 Effect of samples on the hypnotic latency of barbiturate sodium

TABLE 4 experimental results of hypnotic latency of barbiturate sodium

As can be seen from table 4, when the composition of the present invention is orally administered to mice at different doses for 30 days, the sleep latency of each dose group is shortened compared with that of the negative control group, and the difference between the high dose group and the negative control group is very significant (P <0.01), suggesting that the sample has the effect of shortening the sleep latency of barbital sodium.

3. Determination of results

The sleep-aiding traditional Chinese medicine composition provided by the embodiment of the invention with doses of 167, 333 and 666mg/kg BW (equivalent to 5, 10 and 20 times of the doses recommended by a human body) is continuously infused into a stomach of a mouse for 30 days, so that the sleep time of pentobarbital sodium can be prolonged, the sleep latency of the barbital sodium is shortened, a direct sleep effect is avoided, and the weight increase of the mouse is not obviously influenced, thereby prompting that the sample has the function of improving sleep.

The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention are included in the scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims

1. The traditional Chinese medicine composition for aiding sleep is characterized by comprising the following main raw materials in percentage by mass: 24 to 27 percent of spina date seed extract, 9 to 11 percent of lucid ganoderma extract, 8.3 to 10 percent of schisandra extract, 4 to 5 percent of gamma-aminobutyric acid, 2.5 to 4.5 percent of theanine of tea leaves, 1.2 to 1.8 percent of melissa officinalis, 0.3 to 0.7 percent of passion flower extract, 27.5 to 29 percent of red yeast rice, 9.2 to 11 percent of green tea extract and 6 to 8 percent of black ginger extract.

2. The composition as claimed in claim 1, wherein the content of total saponins in the wild jujube seed extract is more than or equal to 2%, the content of crude polysaccharides in the ganoderma lucidum extract is more than or equal to 10%, the content of schizandrol A in the schisandra chinensis extract is more than or equal to 1.0%, and the content of flavones in the passionflower extract calculated by vitexin is more than or equal to 4%.

3. The composition of claim 2, wherein the wild jujube extract is 27%, the ganoderma extract is 9%, the schisandra extract is 8.3%, the gamma-aminobutyric acid is 5%, the theanine is 4.5%, the melissa officinalis is 1.2%, the passionflower extract is 0.3%, the red yeast rice is 27.5%, the green tea extract is 9.2%, and the black ginger extract is 8%.

4. The composition of claim 2, wherein the wild jujube extract is 24%, the ganoderma extract is 11%, the schisandra extract is 10%, the gamma-aminobutyric acid is 4%, the tea theanine is 2.5%, the lemon balm is 1.8%, the passion flower extract is 0.7%, the red yeast rice is 29%, the green tea extract is 11%, and the black ginger extract is 6%.

5. The composition of claim 2, wherein the amount of the wild jujube extract is 25.75%, the amount of the ganoderma lucidum extract is 10.3%, the amount of the schisandra chinensis extract is 9.16%, the amount of the gamma-aminobutyric acid is 4.29%, the amount of theanine is 2.86%, the amount of the melissa officinalis is 1.43%, the amount of the passion flower extract is 0.43%, the amount of the red yeast rice is 28.61%, the amount of the green tea extract is 10.3%, and the amount of the black ginger extract is 6.87%.

6. The composition according to any one of claims 1 to 5, further comprising an adjuvant, wherein the adjuvant is one or more of isomalt, erythritol, microcrystalline cellulose, and magnesium stearate;

7. The composition according to claim 6, wherein the isomalt is 19.69% by mass of the main raw material, the erythritol is 2.86% by mass of the main raw material, the microcrystalline cellulose is 2.63% by mass of the main raw material, and the magnesium stearate is 0.57% by mass of the main raw material.