Traditional Chinese medicine composition for helping sleep as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a sleep-aiding traditional Chinese medicine composition and a preparation method and application thereof. The sleep-aiding traditional Chinese medicine composition is prepared from 50-80 parts of spina date seeds, 50-80 parts of polygala tenuifolia, 50-80 parts of lilies, 50-80 parts of poria cocos, 30-50 parts of red dates, 30-50 parts of lotus seeds, 30-50 parts of longan aril, 30-50 parts of mulberries, 20-30 parts of seaweed polyphenols and 20-30 parts of gamma-aminobutyric acid. Pharmacodynamic tests show that the composition can remarkably shorten the sleep latency time of mice, prolong the total sleep time and remarkably improve the levels of 5-hydroxytryptamine, melatonin and gamma-aminobutyric acid in serum of the mice, so that the composition has an obvious sleep aiding effect through scientific proportioning and synergistic interaction of the raw materials.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine and health food, and particularly relates to a sleep-aiding traditional Chinese medicine composition and a preparation method and application thereof. Background Art

[0002] With the accelerating pace of life, the development of electronic science and technology, and increasing work pressure, insomnia has become a global public health issue and a major factor in various mental health problems. Chronic sleep deprivation can lead to a host of neurological, psychiatric, and sub-health symptoms, such as irritability, depression, decreased alertness and mobility, autonomic nervous system dysfunction, and digestive disorders. It can even weaken the immune system, impact physical health and work efficiency, and reduce quality of life.

[0003] At present, the most effective and most commonly used drugs are sedatives and hypnotics, such as diazepam, zopiclone and midazolam. These drugs have definite efficacy and can achieve immediate results in the initial stage, reducing the number of nighttime awakenings, increasing total sleep time, and improving sleep quality. However, long-term use will have certain side effects on the body, such as drug resistance and dependence, and symptoms such as dizziness, headache, nausea, drowsiness, ataxia, and emotional instability.

[0004] The use of traditional Chinese medicine to treat insomnia has unique advantages, including low toxicity and side effects, no dependence, low patient compliance, and no withdrawal reactions. It also reflects the characteristics of syndrome differentiation and treatment in clinical treatment, and is highly favored in patients' treatment options. There are many kinds of sleep-aiding Chinese medicine compositions on the market, which are often based on traditional medicinal materials such as Chinese jujube seeds and lilies. Although they can improve sleep quality to a certain extent, they generally have problems such as a relatively simple formula structure, insufficient synergistic effect, and unclear mechanism of action. In addition, some products only contain traditional medicinal materials, which have limitations such as limited efficacy, slow onset, and large individual differences. In addition, the traditional ingredient ratios mostly follow empirical models and traditional dosage ratios, lack scientific optimization basis, and it is difficult to accurately exert the advantages of the formula. Summary of the Invention

[0005] To address the shortcomings of the aforementioned prior art, the present invention aims to provide a sleep-enhancing traditional Chinese medicine composition. This composition incorporates classic tranquilizing herbs such as Chinese date seeds, polygala root, lily bulb, and poria, and incorporates seaweed polyphenols and gamma-aminobutyric acid. Through the scientific proportions and synergistic effects of these ingredients, a multi-mechanism sleep-enhancing intervention system is constructed. Pharmacological experiments have demonstrated that this composition significantly shortens sleep-onset latency in mice, prolongs total sleep time, and significantly improves sleep-related serum markers. This demonstrates that this composition, guided by traditional Chinese medicine theory and integrated with modern pharmacological strategies, offers significant advantages in improving sleep.

[0006] The present invention is achieved through the following technical solutions:

[0007] In a first aspect, the present invention provides a sleep-aiding Chinese medicine composition, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0008] 50-80 parts of sour jujube seeds, 50-80 parts of polygala tenuifolia, 50-80 parts of lilies, 50-80 parts of poria cocos, 30-50 parts of red dates, 30-50 parts of lotus seeds, 30-50 parts of longan pulp, 30-50 parts of mulberries, 20-30 parts of seaweed polyphenols, and 20-30 parts of gamma-aminobutyric acid.

[0009] As a further preferred technical solution, the Chinese medicine composition is made of the following raw materials in parts by weight:

[0010] 60-70 parts of spinach seeds, 60-70 parts of polygala tenuifolia, 60-70 parts of lily bulbs, 60-70 parts of poria cocos, 35-45 parts of red dates, 35-45 parts of lotus seeds, 35-45 parts of longan pulp, 35-45 parts of mulberries, 24-28 parts of seaweed polyphenols, and 24-28 parts of gamma-aminobutyric acid.

[0011] As a further preferred technical solution, the Chinese medicine composition is made from the following raw materials in parts by weight:

[0012] 65 parts of spinach seeds, 65 parts of polygala tenuifolia, 65 parts of lilies, 65 parts of poria cocos, 40 parts of red dates, 40 parts of lotus seeds, 40 parts of longan pulp, 40 parts of mulberries, 25 parts of seaweed polyphenols, and 25 parts of gamma-aminobutyric acid.

[0013] The seaweed polyphenols of the present invention can be obtained from commercial products or prepared by the following method:

[0014] (1) The dried seaweed raw material was crushed and extracted twice with 50-60% ethanol solution as the extraction solvent at a raw material to solvent mass ratio of 1:15-20 g / mL at 45-55°C, with each extraction time of 20-40 min;

[0015] (2) The extracts were combined and concentrated under reduced pressure to obtain a concentrate, 95% ethanol was added to the concentrate, mixed and then allowed to settle at 4°C, the precipitate was collected by centrifugation, the supernatant was discarded, and the precipitate was dissolved in a small amount of deionized water, filtered and impurities were removed to obtain a crude extract of seaweed polyphenols;

[0016] (3) The crude extract of seaweed polyphenols is freeze-dried or vacuum-concentrated to prepare a powder.

[0017] The sleep-enhancing Chinese medicine composition of the present invention is based on the core therapeutic principles of "nourishing the heart and calming the mind, replenishing qi and blood, harmonizing the internal organs, and stabilizing the central nervous system." Through the synergistic effects of multiple Chinese medicinal herbs that are both medicinal and edible, it achieves the combined effects of sedation, hypnosis, and improved sleep. The pharmacology, efficacy, and formulation mechanism of each component are as follows:

[0018] ①Core ingredients for calming the nerves and aiding sleep: Ziziphus jujuba seeds, Polygala tenuifolia, Lilium bulbs, Poria cocos, and GABA

[0019] Chinese jujube seeds: They are mild in nature, sweet and sour in flavor, and nourish the heart and liver, calming the mind and tranquilizing the spirit. Traditional Chinese Medicine believes they "nourish heart yin, benefit liver blood, and tranquilize the mind and tranquilize the spirit," making them a commonly used remedy for insomnia. Modern pharmacological research indicates that Chinese jujube seeds, rich in saponins and flavonoids, can enhance the activity of gamma-aminobutyric acid in the central nervous system, exerting significant sedative, hypnotic, and anxiolytic effects, helping to shorten sleep onset and prolong sleep duration.

[0020] Polygala root: Warm in nature, bitter and pungent in flavor, it improves intelligence and soothes the mind, eliminates phlegm and opens the orifices. Traditional Chinese Medicine describes it as "calming the mind and improving intelligence, connecting the heart and kidneys, and eliminating phlegm and opening the orifices." It is used for conditions such as heart-kidney disharmony, insomnia, and forgetfulness. Modern pharmacological research has revealed that Polygala root contains saponins, flavonoids, and various small molecule alkaloids, which promote synaptic regeneration, enhance memory, and relieve anxiety. Polygala root saponins have a calming effect on the central nervous system, reducing central nervous system excitability and promoting sleep, while also improving learning and memory.

[0021] Lily: Slightly cold in nature and sweet in flavor, it nourishes yin and moistens the lungs, clears the heart and calms the mind. Traditional Chinese Medicine believes it nourishes yin and moistens the lungs, clears the heart and calms the mind. It is used to treat restlessness, palpitations, insomnia, and excessive dreaming. Modern research shows that lily contains various alkaloids and saponins that have sedative, anxiolytic, and sleep-inducing effects, relieving stress, promoting relaxation, and facilitating sleep. It can also lower cortisol levels and alleviate stress-induced nervous excitement.

[0022] Poria cocos: It is mild in nature and sweet in flavor. It strengthens the spleen and eliminates dampness, calming the mind and soothing the spirit. Traditional Chinese Medicine believes it "tonifies the spleen and soothes the mind, promotes diuresis and eliminates dampness." It is used for insomnia and forgetfulness caused by both heart and spleen deficiency. Poria cocos contains components such as pachycoryl polysaccharides and pachymic acid, which can improve qi and blood metabolism by strengthening the spleen, indirectly nourishing the mind. The pachycoryl polysaccharides also exhibit certain sedative and immunomodulatory effects, regulating the spleen and eliminating dampness, and promoting rest and sleep.

[0023] Gamma-aminobutyric acid (GABA): As a key inhibitory neurotransmitter in the human central nervous system, GABA binds to GABA receptors, inhibiting neuronal overexcitation, resulting in sedative, anti-anxiety, and sleep-promoting effects. Direct GABA supplementation can enhance the GABA system's effects, coordinating the effects of the entire formula, enhancing its calming effects, and accelerating the onset of deep sleep.

[0024] ② Nourishes the heart and spleen, replenishes Qi and blood Ingredients: red dates, lotus seeds, longan meat, mulberries

[0025] Red dates: Warm in nature and sweet in flavor, they tonify the middle and replenish qi, nourish blood and calm the mind. Traditional Chinese Medicine (TCM) describes them as "tonifying the middle and replenishing qi, nourishing blood and calming the mind." They are effective for insomnia caused by qi and blood deficiency and restlessness. Modern research shows that red dates are rich in polysaccharides, saponins, vitamins, and amino acids, which can improve physical fitness and support nervous system function.

[0026] Lotus seeds: They are mild in nature, sweet and astringent in flavor. They nourish the spleen, stop diarrhea, and nourish the heart and calm the mind. Traditional Chinese Medicine believes they "tonify the kidneys and strengthen essence, tonify the spleen and stop diarrhea, and nourish the heart and calm the mind." They are used to treat heart-kidney disharmony, palpitations, and insomnia. Lotus seeds are rich in alkaloids such as liensinine and nelumbosamine, which have sedative and antiarrhythmic effects, can help stabilize mood, and promote sleep.

[0027] Longan flesh: Warm in nature and sweet in flavor, it nourishes the heart and spleen, nourishes blood and calms the mind. Traditional Chinese Medicine (TCM) states that it "tonifies the heart and spleen, nourishes blood and calms the mind." It is used to treat Qi and blood deficiency, palpitations, insomnia, and forgetfulness. Longan flesh contains a variety of sugars, polyphenols, and volatile oils, which effectively replenish essential nutrients and improve Qi and blood circulation, thereby indirectly nourishing the mind and alleviating insomnia caused by heart and spleen deficiency.

[0028] Mulberries: Cold in nature and sweet in flavor, they nourish yin and blood, moisturize dryness and calm the mind. Traditional Chinese Medicine believes they "tonify the liver and kidneys, nourish yin and blood." They are used to treat liver and kidney yin deficiency, dizziness, insomnia, and tinnitus. Rich in natural active ingredients like anthocyanins and resveratrol, mulberries have antioxidant, anti-fatigue, and sleep-enhancing properties.

[0029] ③Highly active and innovative synergistic components: seaweed polyphenols

[0030] Seaweed polyphenols are marine natural products extracted from natural brown algae. They have the effects of clearing away heat and detoxifying, resolving phlegm and softening hard masses. As an emerging marine bioactive substance, seaweed polyphenols have significant antioxidant, anti-inflammatory and neuroprotective effects. Several studies have confirmed that seaweed polyphenols can exert sedative and anti-anxiety effects by activating GABA_A receptors, inhibiting monoamine oxidase activity, and reducing cortisol release. In addition, seaweed polyphenols can indirectly exert sedative and hypnotic effects by inhibiting neuroinflammation, regulating neurotransmitter metabolism, alleviating oxidative stress damage to nerve cells, and improving the excitement state of the central nervous system. The present invention introduces it into the prescription, aiming to provide additional neuroprotection and regulatory effects, synergistically enhance the overall sleep-inducing effect, and add modern scientific connotations to the traditional prescription.

[0031] In summary, the Chinese medicine composition of the present invention uses Chinese jujube seeds as the main ingredient, which plays its core role of nourishing the heart and calming the mind, and significantly inducing hypnosis. It is supplemented with auxiliary medicines such as red dates, lotus seeds, lilies, and longan meat that nourish the heart and spleen, calm the mind and nourish the blood, and jointly improve insomnia caused by deficiency of both the heart and spleen; it is supplemented with medicinal materials such as Polygala tenuifolia, Poria cocos, mulberries, and seaweed polyphenols to help resolve phlegm and open the mind, calm the mind, resist oxidation, and regulate the balance of neurotransmitters; and introduces γ-aminobutyric acid as a guiding drug to strengthen the GABA-mediated central inhibitory system from the perspective of modern pharmacology, and quickly improve sleep efficiency. Most of the ingredients in the prescription, such as red dates, lotus seeds, lilies, Poria cocos, longan meat, and mulberries, are in the category of medicine and food, are edible daily, and are highly safe. The innovative addition of seaweed polyphenols introduces the neuroprotective and regulatory potential of marine bioactive substances, injects modern scientific and technological elements into traditional sleep-aid prescriptions, and broadens the sleep-aid mechanism. The overall formula is based on the principle of "tonifying Qi and nourishing blood, calming the mind and tranquilizing the spirit", taking into account the functional regulation of the central nervous system and the support of emotional stability, achieving a multi-target synergistic sleep-aiding effect, and conforming to the organic integration of the logic of the monarch, minister, assistant and envoy compatibility of traditional Chinese medicine formulas and the modern neuropharmacology mechanism.

[0032] In a second aspect, the present invention further provides a method for preparing the above-mentioned sleep-aiding Chinese medicine composition, comprising the following steps:

[0033] (1) Crush and mix spinach seeds, polygala root, lily, poria, red dates, lotus seeds, longan pulp, and mulberry according to weight ratio, add water and boil twice, collect the two extracts, and obtain a mixed extract;

[0034] (2) Add seaweed polyphenols and γ-aminobutyric acid to the mixed extract in proportion and stir evenly to obtain the mixture.

[0035] Preferably, in step (1), each raw material drug is crushed to 10-20 mesh.

[0036] Preferably, in step (1), the first decoction time is 20-60 min, and the material-liquid ratio is 1:8-15; the second decoction time is 20-60 min, and the material-liquid ratio is 1:6-10.

[0037] Preferably, in step (2), the stirring temperature is 55-65°C.

[0038] In a third aspect, the present invention further provides use of the aforementioned sleep-aiding Chinese medicine composition in the preparation of sleep-aiding medicines or health foods.

[0039] The medicine or health food of the present invention comprises an effective amount of a Chinese medicine composition and a pharmaceutically or food-acceptable carrier. The pharmaceutically or food-acceptable carrier includes but is not limited to a lubricant, a pH adjuster, a penetration enhancer, a plasticizer, an antioxidant, a preservative, and the like.

[0040] The medicine or health food of the present application can be prepared according to the conventional method in the art, and the dosage form of the medicine or health food includes oral liquid, granules, powder, capsules or tablets.

[0041] Compared with the prior art, the present application has the following advantages:

[0042] The sleep-aiding traditional Chinese medicine composition provided by the present application is prepared from scientifically matched homoeopathic raw materials of seaweed polyphenol, red dates, lotus seeds, polygala, lilies, poria cocos, longan arillus, mulberry, jujube kernel and gamma-aminobutyric acid. The pharmacodynamic test results show that the composition can significantly shorten the sleep latency of mice, prolong the total sleep time, and show good sedative and hypnotic effects in the aspect of sleep behavior, and can significantly improve the levels of 5-hydroxytryptamine, melatonin and gamma-aminobutyric acid in serum, indicating that the composition has obvious sleep-aiding effect through scientific matching and synergistic effect of the raw materials.

[0043] The traditional Chinese medicine composition is rich in natural functional components with the effects of soothing the nerves, calming the heart, sedation and regulating biological rhythm, has important potential in regulating sleep behavior and sleep serum indicators, and its mechanism of action involves multiple dimensions such as sleep initiation, sleep maintenance, neurotransmitter and hormone secretion regulation, and has good sleep-aiding health care efficacy and development and application potential. BRIEF DESCRIPTION OF DRAWINGS

[0044] Figure 1 The mice are in a sleep state;

[0045] Figure 2 The results of sleep latency and total sleep time of the mice in each group;

[0046] Figure 3 The results of sleep-aiding index detection of the serum of the mice in each group. DETAILED DESCRIPTION

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

[0048] The test materials used in the embodiments of the present application are all conventional test materials in the art, and can be purchased through commercial channels.

[0049] Preparation method of seaweed polyphenol:

[0050] The dried seaweed raw material was pulverized until it passed through a 40-mesh sieve. A 50% ethanol solution was added as the extraction solvent at a raw material to solvent mass ratio of 1:20 (g / mL). The mixture was placed in a multifunctional extraction tank and refluxed at 50°C for two extractions, each lasting 30 minutes. The combined extracts were concentrated under reduced pressure at 50°C to remove the ethanol, yielding an aqueous concentrate. Three volumes of 95% ethanol were then slowly added to the concentrate, mixed thoroughly, and allowed to settle at 4°C for 12 hours. The precipitate was collected by centrifugation, the supernatant discarded, and dissolved in a small amount of deionized water. After filtration and impurity removal, the crude seaweed polyphenol extract was obtained. The resulting extract can be freeze-dried or vacuum-concentrated to prepare a powder for later use.

[0051] Example 1:

[0052] A sleep-aiding Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0053] 65 parts of spinach seeds, 65 parts of polygala tenuifolia, 65 parts of lily bulbs, 65 parts of poria cocos, 40 parts of red dates, 40 parts of lotus seeds, 40 parts of longan pulp, 40 parts of mulberries, 25 parts of seaweed polyphenols, and 25 parts of gamma-aminobutyric acid;

[0054] The preparation method comprises the following steps:

[0055] (1) Accurately weigh all raw materials according to the prescription ratio, remove impurities and grind them into appropriate particle size (10-20 mesh), and set aside;

[0056] (2) The medicinal material and purified water were mixed in a ratio of 1:10 (w / v), placed in an extraction tank, heated to boiling, and decocted at a slight boiling state for 30 minutes. After the end, the mixture was filtered while hot to collect the first extract; the medicinal residue was added with purified water in a ratio of 1:8 (w / v), decocted again for 30 minutes, and then hot filtered again to collect the second extract; the two filtrates were combined and allowed to stand for clarification, and suspended impurities were removed by filtering through filter cloth to obtain a clarified mixed extract;

[0057] (3) Add seaweed polyphenols and γ-aminobutyric acid to the mixed extract in proportion, stir thoroughly at room temperature to dissolve them evenly, and if necessary, dissolve them in a 60°C water bath to obtain the product.

[0058] Example 2:

[0059] A sleep-aiding Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0060] 52 parts of spinach seeds, 52 parts of polygala tenuifolia, 52 parts of lily bulbs, 52 parts of poria cocos, 48 ​​parts of red dates, 48 ​​parts of lotus seeds, 48 ​​parts of longan pulp, 48 parts of mulberries, 28 parts of seaweed polyphenols, and 28 parts of gamma-aminobutyric acid;

[0061] The preparation method is the same as that in Example 1.

[0062] Example 3:

[0063] A sleep-aiding traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0064] Semen ziziphi spinozae 78 parts, polygala 78 parts, lily 78 parts, poria cocos 78 parts, red dates 32 parts, lotus seeds 32 parts, longan arillus 32 parts, mulberry 32 parts, sea algae polyphenol 21 parts, γ-aminobutyric acid 21 parts;

[0065] The preparation method is the same as that in Example 1.

[0066] Example 4:

[0067] A sleep-aiding traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0068] Semen ziziphi spinozae 60 parts, polygala 60 parts, lily 60 parts, poria cocos 60 parts, red dates 45 parts, lotus seeds 45 parts, longan arillus 45 parts, mulberry 45 parts, sea algae polyphenol 24 parts, γ-aminobutyric acid 24 parts;

[0069] The preparation method is the same as that in Example 1.

[0070] Example 5:

[0071] A sleep-aiding traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0072] Semen ziziphi spinozae 70 parts, polygala 70 parts, lily 70 parts, poria cocos 70 parts, red dates 38 parts, lotus seeds 38 parts, longan arillus 38 parts, mulberry 38 parts, sea algae polyphenol 26 parts, γ-aminobutyric acid 26 parts;

[0073] The preparation method is the same as that in Example 1.

[0074] Comparative Example 1:

[0075] A sleep-aiding traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0076] Semen ziziphi spinozae 65 parts, lily 65 parts, poria cocos 65 parts, red dates 40 parts, longan arillus 40 parts;

[0077] The preparation method is the same as that in Example 1.

[0078] Comparative Example 2:

[0079] A sleep-aiding traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0080] Semen ziziphi spinozae 65 parts, lily 65 parts, poria cocos 65 parts, red dates 40 parts, lotus seeds 40 parts, longan arillus 40 parts, mulberry 40 parts, γ-aminobutyric acid 25 parts;

[0081] The preparation method is the same as that in Example 1.

[0082] Comparative Example 3:

[0083] A sleep-aiding Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0084] 65 parts of Polygala tenuifolia, 65 parts of Lilium bulbs, 65 parts of Poria cocos, 40 parts of red dates, 40 parts of lotus seeds, 40 parts of longan pulp, 40 parts of mulberries, and 25 parts of seaweed polyphenols;

[0085] The preparation method is the same as that in Example 1.

[0086] Test Example 1:

[0087] Get 96 5 week-old SPF level healthy BALB / c male mice, body weight is (20 ± 2) g, and experiment starts before adaptability is raised 1 week.Mice are randomly divided into 6 groups, 16 in every group, be respectively control group, model group, embodiment 1 group, comparative example 1 group, comparative example 2 group and comparative example 3 group.Control group and model group gavage normal saline, other 4 groups of respectively continuous gavage embodiment 1, comparative example 1, comparative example 2, comparative example 3 prepared oral liquid 32 days, every day 1 time.Except control group, all the other each group all carry out the sleep experiment of sodium pentobarbital induction at experiment the 33rd day, concrete operations are: fast 4 hours in advance, give each group mouse intraperitoneal injection sodium pentobarbital (30mg / kg BW), injection volume is 0.2mL / 20g, take mouse righting reflex disappearance as index, record sleep latency and total sleep time respectively. Eight rats in each group underwent sleep behavior monitoring, and the other eight rats were immediately killed after entering a stable sleep state. Their eyeballs were removed and blood was collected. The levels of 5-hydroxytryptamine, melatonin and γ-aminobutyric acid in the serum were detected by ELISA.

[0088] SPF animal breeding conditions:

[0089] Temperature: 25 ± 2°C; relative humidity: 55% ± 5%; light exposure for 12 h per day (free access to food and water). Animal experimental procedures were conducted in accordance with the Guiding Opinions on the Ethical Treatment of Laboratory Animals and strictly adhered to the 3R (replacement, reduction, and optimization) principles of Animal Ethics.

[0090] 1. Pentobarbital sodium-induced sleep model

[0091] Figure 1 The mice were in a sleeping state, and the disappearance of the lying down and righting reflex was used as an indicator as the time point for the mice to enter sleep, indicating that the model was successfully established.

[0092] 2. Pentobarbital-induced sleep time test

[0093] Figure 2The results showed that compared with the model group, Example 1, Comparative Example 1, Comparative Example 2, and Comparative Example 3 groups all improved sleep-related behavioral indicators to varying degrees, manifested as shortened sleep latency and prolonged total sleep time, suggesting that each intervention group had a certain degree of sedative and hypnotic potential. Among them, Example 1 had a significantly better sleep-inducing effect than Comparative Examples 1-3, with the shortest sleep latency and the longest total sleep time.

[0094] 3. Detection of sleep-promoting serum indicators in mice

[0095] (1) Mouse serum melatonin detection method:

[0096] Melatonin levels in mouse serum were measured using a melatonin assay kit provided by Shanghai Yanteng Biotechnology Co., Ltd. After the experiment, ocular blood was collected from the mice, allowed to stand for 30 minutes, and then centrifuged at 3000 rpm for 10 minutes at 4°C to separate the serum for later use. For the assay, melatonin assay working solution, biotin-antibody working solution, enzyme conjugate working solution, and 1× wash buffer were prepared according to the kit instructions. Blank wells, standard wells, and sample wells were set up separately. 50 μL of melatonin assay working solution was added to each well, followed by 50 μL of universal diluent in the blank wells. Then, 50 μL of biotin-antibody working solution was added to each well. The plates were sealed with film and incubated at 37°C for 1 hour. The remaining liquid was discarded, and 300 μL of 1× wash buffer was added to each well. The plates were allowed to stand for 1 minute, the wash buffer was shaken off, and the plates were patted dry on absorbent paper. The plates were washed three times. Then, 100 μL of enzyme conjugate working solution was added to each well. The plates were sealed with film and incubated at 37°C for 30 minutes. The remaining liquid was discarded, and the plates were washed five times. Add 90 μL of substrate (TMB) to each well, cover with a sealing film, and incubate at 37°C in the dark for 15 minutes. Finally, add 50 μL of stop solution to each well to terminate the reaction. Measure the absorbance (OD) of each well at a wavelength of 450 nm using a microplate reader. Calculate the serum melatonin concentration based on the standard curve. The result is expressed in pg / mL.

[0097] (2) Mouse serum 5-HT detection method

[0098] The 5-HT assay kit provided by Shanghai Yanteng Biotechnology Co., Ltd. was used to measure 5-HT levels in mouse serum. After the experiment, eye blood was collected from the mice, allowed to stand for 30 minutes, and then centrifuged at 3000 rpm for 10 minutes at 4°C to separate the serum for later use. For the assay, the 5-HT assay working solution, Biotin-antibody working solution, enzyme conjugate working solution, and 1× wash buffer were prepared according to the kit instructions. Blank wells, standard wells, and sample wells were set up separately. 50 μL of the 5-HT assay working solution was added to each well, followed by 50 μL of universal diluent in the blank wells. Then, 50 μL of Biotin-antibody working solution was added to each well. The plates were sealed with film and incubated at 37°C for 1 hour. The remaining liquid was discarded, and 300 μL of 1× wash buffer was added to each well. The plates were allowed to stand for 1 minute, then the wash buffer was shaken off and patted dry on absorbent paper. The plates were washed three times. Then, 100 μL of the enzyme conjugate working solution was added to each well. The plates were sealed with film and incubated at 37°C for 30 minutes. Discard the liquid and wash the plate five times. Add 90 μL of substrate (TMB) to each well, cover with film, and incubate at 37°C in the dark for 15 minutes. Finally, add 50 μL of stop solution to each well to terminate the reaction. Measure the absorbance (OD) of each well at a wavelength of 450 nm using a microplate reader. Calculate the serum 5-HT concentration based on the standard curve and express the result in ng / mL.

[0099] (3) Mouse serum γ-aminobutyric acid detection method

[0100] The γ-aminobutyric acid (GABA) content in mouse serum was determined using a GABA detection kit provided by Unicore (Shanghai) Life Sciences Co., Ltd. After the experiment, eye blood was collected from the mice, allowed to stand for 30 minutes, and then centrifuged at 3000 rpm for 10 minutes at 4°C to separate the serum for later use. For the assay, 0.1 mL of serum was added to 1 mL of GABA extract in a 1.5 mL EP tube. The tube was mixed thoroughly, tightly capped, and extracted in a 95°C water bath for 2 hours. After cooling, the tube was centrifuged at 8000 rpm for 10 minutes at room temperature. The supernatant was used as the test sample. The reaction mixture was prepared according to the kit instructions. Blank, standard, and sample tubes were set up separately. The mixture was mixed thoroughly, and 200 μL of each tube was added to the corresponding blank, standard, and sample wells of a 96-well plate. The absorbance (OD value) was then measured at 640 nm using a microplate reader. The GABA concentration in the serum was calculated based on the standard curve and expressed in μmol / mL.

[0101] like Figure 3The results show that in the pentobarbital sodium-induced mouse sleep model, compared with the control group, the levels of 5-hydroxytryptamine, melatonin and γ-aminobutyric acid in the serum of the model group mice were significantly increased, suggesting that the body activates the sleep state by increasing the secretion of inhibitory neurotransmitters, hormones, etc. On this basis, Example 1, Comparative Example 1, Comparative Example 2 and Comparative Example 3 further improved the secretion levels of the three indicators to varying degrees, suggesting that they have a synergistic activation effect on the central inhibitory system. Among them, Example 1 has the most significant regulatory effect on the above-mentioned serum indicators, and its improvement is significantly better than that of Comparative Examples 1 to 3. Comprehensive analysis shows that Example 1 achieves multi-target and multi-level synergistic sedation and sleep assistance by enhancing 5-hydroxytryptamine anabolism, promoting melatonin secretion and activating GABA-mediated central inhibitory pathways. Its mechanism may be closely related to the regulation of neurotransmitter homeostasis, melatonin biorhythm regulation and enhancement of central inhibitory signals.

[0102] In summary, the comparison of the results of Example 1 and Comparative Examples 1-3 shows that the present invention has a significant sleep-inducing effect by compounding the raw materials of jujube seeds, polygala tenuifolia, lily, poria cocos, red dates, lotus seeds, longan meat, mulberry, seaweed polyphenols and γ-aminobutyric acid, which work synergistically.

Claims

1. A Chinese medicine composition for aiding sleep, characterized in that: The Chinese medicine composition is made from the following raw materials in parts by weight: 50-80 parts of sour jujube seeds, 50-80 parts of polygala tenuifolia, 50-80 parts of lilies, 50-80 parts of poria cocos, 30-50 parts of red dates, 30-50 parts of lotus seeds, 30-50 parts of longan pulp, 30-50 parts of mulberries, 20-30 parts of seaweed polyphenols, and 20-30 parts of gamma-aminobutyric acid.

2. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is made from the following raw materials in parts by weight: 60-70 parts of spinach seeds, 60-70 parts of polygala tenuifolia, 60-70 parts of lily bulbs, 60-70 parts of poria cocos, 35-45 parts of red dates, 35-45 parts of lotus seeds, 35-45 parts of longan pulp, 35-45 parts of mulberries, 24-28 parts of seaweed polyphenols, and 24-28 parts of gamma-aminobutyric acid.

3. The Chinese medicine composition according to claim 2, characterized in that The Chinese medicine composition is made from the following raw materials in parts by weight: 65 parts of spinach seeds, 65 parts of polygala tenuifolia, 65 parts of lilies, 65 parts of poria cocos, 40 parts of red dates, 40 parts of lotus seeds, 40 parts of longan pulp, 40 parts of mulberries, 25 parts of seaweed polyphenols, and 25 parts of gamma-aminobutyric acid.

4. The Chinese medicine composition according to any one of claims 1 to 3, characterized in that The preparation method of seaweed polyphenols comprises the following steps: (1) The dried seaweed raw material was crushed and extracted twice with 50-60% ethanol solution as the extraction solvent at a raw material to solvent mass ratio of 1:15-20 g / mL at 45-55°C, with each extraction time of 20-40 min; (2) The extracts were combined and concentrated under reduced pressure to obtain a concentrate, 95% ethanol was added to the concentrate, mixed and then allowed to settle at 4°C, the precipitate was collected by centrifugation, the supernatant was discarded, and the precipitate was dissolved in a small amount of deionized water, filtered and impurities were removed to obtain a crude extract of seaweed polyphenols; (3) The crude extract of seaweed polyphenols is freeze-dried or vacuum-concentrated to prepare a powder.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The steps include: (1) Crush and mix spinach seeds, polygala root, lily, poria, red dates, lotus seeds, longan pulp, and mulberry according to weight ratio, add water and boil twice, collect the two extracts, and obtain a mixed extract; (2) Add seaweed polyphenols and γ-aminobutyric acid to the mixed extract in proportion and stir evenly to obtain the product.

6. The method for preparing the Chinese medicine composition according to claim 5, wherein: In step (1), the first decoction time is 20-60 minutes, and the material-liquid ratio is 1:8-15; the second decoction time is 20-60 minutes, and the material-liquid ratio is 1:6-10.

7. The method for preparing the Chinese medicine composition according to claim 5, wherein: In step (2), the stirring temperature is 55-65°C.

8. Use of the traditional Chinese medicine composition according to any one of claims 1 to 4 in the preparation of sleep-aiding medicines or health foods.

9. The use according to claim 8, characterized in that The medicine or health food comprises an effective amount of a traditional Chinese medicine composition and a pharmaceutically or food-acceptable carrier.

10. The use according to claim 9, characterized in that The dosage form of the drug includes oral liquid, granules, powder, capsule or tablet.

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