Composition for promoting falling asleep and prolonging deep sleep and preparation method thereof

Abstract

The invention relates to the technical field of functional food, in particular to a composition for promoting falling asleep and prolonging deep sleep and a preparation method thereof. The composition is prepared from the following components in parts by mass: 40 to 60 parts of semen ziziphi spinosae extract, 280 to 320 parts of gamma-aminobutyric acid, 45 to 55 parts of tea leaf theanine, 40 to 60 parts of poria cocos extract and 40 to 60 parts of lily bulb extract. The invention also provides a preparation method of the composition. The composition which is good in sleep aiding effect, good in taste and stable in system is formed by effectively aiding sleep and improving the sleep quality through the main raw materials, improving the taste through the taste auxiliary materials and stabilizing the system through the functional auxiliary materials. The main active ingredients come from plants and natural sources, so that the dependency of chemical auxiliaries is avoided, and the safety is high. The defect that in the prior art, sleep aiding products are limited in safety, effectiveness and applicability is overcome.

Description

Technical Field

[0001] This invention relates to the field of functional food technology, specifically to a plant-based composition that promotes sleep and prolongs deep sleep time, and its preparation method. Background Technology

[0002] With the fast pace of modern life, sleep disorders are becoming increasingly prominent. However, long-term use of chemically synthesized drugs to aid sleep can easily lead to dependence and side effects. Among pharmaceutical sleep aids, benzodiazepines... Long-term use of these drugs can easily lead to dependence and adverse reactions, while non-benzodiazepines... Tolerance issues also exist with certain medications; melatonin can disrupt the body's secretion rhythm and has limited applicability. In the health supplement field, single-ingredient gamma-aminobutyric acid (GABA) products have limited actual sleep-aiding effects due to their difficulty in crossing the blood-brain barrier; jujube seed extract varies in quality, has a narrow range of applicable symptoms, and its use as a single ingredient can easily cause adverse reactions. Single active ingredients cannot simultaneously achieve the full-cycle regulation of sleep—"inhibiting nerve excitation, relieving stress, and promoting deep relaxation." Furthermore, the inherent bitterness of traditional Chinese medicine preparations leads to poor user compliance, making it difficult to persist with use and resulting in insignificant therapeutic effects.

[0003] This led to the emergence of plant-based sleep aids. However, most existing plant-based sleep aids use a single ingredient, which results in slow onset of action and insufficient regulation of deep sleep.

[0004] Overall, existing sleep aids have limitations in terms of safety, effectiveness, and applicability, and there is an urgent need to develop new, natural, effective, and widely applicable sleep aids. Summary of the Invention

[0005] To address the limitations of existing sleep aid products in terms of safety, effectiveness, and applicability, this invention provides a composition with excellent efficacy and safety, along with its preparation method. This composition improves sleep quality, promotes sleep onset, and prolongs deep sleep. The main active ingredients are derived from plants and natural sources, avoiding dependence on chemical additives and ensuring high safety.

[0006] To achieve the above objectives, the present invention adopts the following technical solution:

[0007] In a first aspect, the present invention provides a composition for promoting sleep onset and prolonging deep sleep, the composition comprising, by weight parts: 40-60 parts of jujube seed extract, 280-320 parts of γ-aminobutyric acid, 45-55 parts of tea theanine, 40-60 parts of Poria cocos extract, and 40-60 parts of lily extract.

[0008] Furthermore, the composition, by weight parts, also includes flavoring agents and functional agents.

[0009] Further, the taste auxiliary ingredient comprises erythritol 580-620 parts by mass, sucralose 4-8 parts by mass, citric acid 40-80 parts by mass, malic acid 20-40 parts by mass, and prune concentrate juice 100-200 parts by mass.

[0010] Further, the functional auxiliary ingredient comprises xanthan gum 10-20 parts by mass, potassium sorbate 10-20 parts by mass, vitamin C 80-120 parts by mass, and highland barley red koji fermentation product 1-3 parts by mass.

[0011] Further, the total saponin content of the Zizyphus jujuba Mill. extract is greater than 3.0% by mass.

[0012] Further, the polysaccharide content of the lily extract is greater than 50% by mass.

[0013] Further, the polysaccharide content of the Poria cocos extract is greater than 70% by mass.

[0014] In a second aspect, the application provides a preparation method of the composition for promoting sleep and prolonging deep sleep, comprising the following steps:

[0015] The raw materials are taken according to the formula, and the prune concentrate juice, citric acid and malic acid are mixed to obtain an acid base;

[0016] The xanthan gum and erythritol are dry-mixed, and then added into pure water, and high-speed shearing dispersion is performed to obtain a mixture;

[0017] The Zizyphus jujuba Mill. extract, theanine, gamma-aminobutyric acid, Poria cocos extract, lily extract and highland barley red koji fermentation product are added into the mixture, and homogenization treatment is performed to obtain a first solution;

[0018] The first solution is added into the acid base, and sucralose, potassium sorbate and vitamin C are added;

[0019] The volume is fixed, filtration and sterilization are performed to obtain the composition.

[0020] Further, the temperature of the pure water is 60-70°C.

[0021] The application has the following beneficial effects:

[0022] 1. The composition for promoting sleep and prolonging deep sleep has good effects and high safety, effectively promotes sleep and improves sleep quality through the main raw materials, improves the taste through the taste auxiliary ingredient, and stabilizes the system through the functional auxiliary ingredient, thereby forming a composition with good sleep-promoting effect, good taste and stable system. The main active ingredients are derived from plants and natural sources, avoiding the dependence on chemical additives and improving the safety. The application solves the problems of the sleep-promoting products in the prior art, such as safety, effectiveness and applicability.

[0023] 2. The preparation method of the composition for promoting falling asleep and prolonging deep sleep according to the application is relatively simple and convenient, easy for industrialized production, and has a wide application range. DETAILED DESCRIPTION

[0024] In order to make the skilled in the art better understand the technical solutions of the application, the application will be further described in detail below in combination with specific embodiments.

[0025] The embodiment of the application provides a composition for promoting falling asleep and prolonging deep sleep, which comprises, in terms of mass fraction, 40-60 parts of Zizyphus jujuba Mill. extract, 280-320 parts of gamma-aminobutyric acid, 45-55 parts of theanine, 40-60 parts of Poria cocos extract and 40-60 parts of lily extract.

[0026] In some embodiments of the application, the composition further comprises a taste auxiliary material and a functional auxiliary material in terms of mass fraction.

[0027] In some embodiments of the application, the taste auxiliary material comprises, in terms of mass fraction, 580-620 parts of erythritol, 4-8 parts of sucralose, 40-80 parts of citric acid, 20-40 parts of malic acid and 100-200 parts of Prunus domestica L. concentrate juice.

[0028] In some embodiments of the application, the functional auxiliary material comprises, in terms of mass fraction, 10-20 parts of xanthan gum, 10-20 parts of potassium sorbate, 80-120 parts of vitamin C and 1-3 parts of barley monascus fermentation product.

[0029] In some embodiments of the application, the mass percentage of total saponins in the Zizyphus jujuba Mill. extract is greater than 3.0% in terms of dry weight.

[0030] In some embodiments of the application, the mass percentage of polysaccharides in the lily extract is greater than 50% in terms of dry weight.

[0031] In some embodiments of the application, the mass percentage of polysaccharides in the Poria cocos extract is greater than 70% in terms of dry weight.

[0032] In some embodiments of the application, the soluble solid content of the Prunus domestica L. concentrate juice is greater than or equal to 65 °Brix.

[0033] In some embodiments of the application, the mass percentage of lovastatin in the barley monascus fermentation product is greater than 0.2% in terms of dry weight.

[0034] In some embodiments of the application, the purity of the gamma-aminobutyric acid is greater than or equal to 98%.

[0035] In some embodiments of the present application, the tea theanine has a purity of ≥98%.

[0036] The main raw material has multiple neuromodulation systems: first, the extract of Suanzaoren plays a role of sedation, anti-anxiety and sleep promotion mainly by regulating the balance of central neurotransmitters (such as GABA, 5-HT) and inhibiting the overactivation of hypothalamic-pituitary-adrenal (HPA) axis. In addition, the active ingredients contained therein (such as saponins and flavonoids) also exhibit anti-inflammatory and antioxidant stress effects, which may provide an auxiliary mechanism for its neuroprotective effect, thereby comprehensively improving sleep disorders caused by stress and mental tension.

[0037] The tea theanine can be absorbed through the intestinal tract and then competitively cross the blood-brain barrier through specific amino acid transport systems. It mainly functions by regulating the central neurotransmitter system (such as possibly affecting glutamic acid, GABA and dopaminergic system), and significantly enhances the alpha brain wave activity in a relaxed state of wakefulness. The dominant state of alpha waves is closely related to the reduction of physical and mental stress and the enhancement of relaxation, thereby creating favorable conditions for reducing pre-sleep nervousness and smoothly transitioning to sleep. Therefore, tea theanine indirectly promotes sleep mainly by relieving anxiety and promoting relaxation.

[0038] Gamma-aminobutyric acid (GABA) is the most important inhibitory neurotransmitter in the central nervous system, which can mediate neuronal hyperpolarization inhibition after binding to GABA-A receptors.

[0039] Poria cocos extract and lily are rich in active polysaccharide ingredients: Poria cocos polysaccharide and lily polysaccharide. Existing research shows that Poria cocos extract mainly regulates the gut microbiota-brain axis to exert systemic anti-inflammatory and immunoregulatory effects, effectively stabilizes the internal environment, consolidates the sleep structure, reduces nighttime awakenings, and thus prolongs deep sleep time. Lily extract focuses on clearing the heart and calming the mind, and through its anti-inflammatory and potential mood regulation functions, it relieves sleep disorders caused by anxiety and mental stress, creating an optimal emotional premise for the core ingredients to function. Poria cocos polysaccharide and lily polysaccharide, through the above mechanisms, form a functional complement with the core ingredients: Suanzaoren saponin, theanine, GABA, indirectly support and enhance the overall sleep quality improvement effect.

[0040] The multiple raw materials in the present composition form a stable system through compounding, building a multiple neuromodulation system, starting from inhibiting central nervous excitation, promoting relaxation, relieving stress, enhancing immunity and other multiple dimensions, and comprehensively covering the entire chain of falling asleep. First, promote sleep, then regulate the deep sleep ratio during the sleep process, so that deep sleep is longer, and the overall effect is good.

[0041] Jujube seed saponins can activate GABA-A receptor function, enhance inhibitory neurotransmission, and reduce neuronal excitability, thereby aiding in sleep induction. Tea theanine can be absorbed through the intestines and cross the blood-brain barrier, inducing relaxation and anti-anxiety states by regulating the central neurotransmitter system (such as affecting the balance of glutamate and GABA) and promoting alpha brain wave generation, thus creating favorable conditions for sleep initiation. Gamma-aminobutyric acid (GABA), as a direct ligand of the GABAergic system, can directly supplement inhibitory neurotransmitters and rapidly generate sedative signals.

[0042] Mechanistically, jujube seed extract, tea theanine, and γ-aminobutyric acid (GABA) form a multi-target regulatory network by acting on related but different targets: tea theanine mainly regulates the glutamatergic system and induces alpha brain waves, reducing the background excitability of the central nervous system and creating optimized "environmental conditions" for the efficient operation of the GABAergic system; γ-aminobutyric acid, as an endogenous agonist of GABA-A receptors, is an "activator" of inhibitory neural signals, providing rapid inhibitory signals and directly initiating the sleep process; simultaneously, jujube seed saponins exert deeper and more sustained regulation on the GABAergic system, jointly enhancing the output of inhibitory neural signals. The combined use of these three substances covers the complete chain from "anxiety relief" to "signal initiation" to "sleep maintenance," thereby more comprehensively and effectively improving sleep quality, shortening sleep latency, and prolonging sleep duration.

[0043] The added barley red yeast rice fermentation product contains lovastatin and a variety of fermentation active substances, which can help regulate the physiological function of blood lipids, improve the body's microcirculation and cardiovascular health, and create a more suitable internal physiological environment for sleep in the brain, thereby providing support for the overall improvement of sleep quality from a fundamental level.

[0044] Furthermore, this composition exhibits good system stability, and the functional excipients can work in conjunction with the main raw materials to form a natural preservative system, effectively inhibiting bacteria and providing antioxidant effects. The functional excipients can also regulate the physical state of the system, resulting in good homogeneity and morphological stability, further enhancing the smoothness of the texture.

[0045] The addition of flavoring agents and optimization of their proportions in the composition enable it to work effectively with the main ingredients, mask the bitterness of other ingredients, and improve the taste. This results in the composition being effective and having a good taste when used in functional foods.

[0046] First, erythritol and sucralose enhance the sweetness and form a low-calorie sweetness system, improving palatability. Furthermore, the added prune concentrate contains polyphenols and natural fruit flavor, effectively masking the bitterness of herbs, replenishing fruit acids, and enhancing taste acceptance; combined with flavoring agents, this results in a highly palatable composition.

[0047] Specifically, potassium sorbate in the functional excipients combines with γ-aminobutyric acid (GABA), an organic acid in the main raw material, to form a natural preservative system with a synergistic effect, effectively inhibiting mold / yeast. Vitamin C in the functional excipients chelates metal ions, preventing the oxidative degradation of active ingredients and providing antioxidant protection, further enhancing the system's stability and antioxidant properties. The xanthan gum added to the functional excipients promotes the formation of a shear-thinning fluid in the composition, effectively preventing liquid sedimentation, improving liquid uniformity, and enhancing the smoothness of the texture.

[0048] In a second aspect, the present invention provides a method for preparing a composition as described above that promotes sleep onset and prolongs deep sleep, comprising the following steps:

[0049] Take the raw materials according to the formula, and mix prune concentrate, citric acid and malic acid to obtain the sour base;

[0050] Xanthan gum and erythritol were dry-mixed and then added to pure water, and dispersed by high-speed shearing to obtain a mixture.

[0051] Add jujube seed extract, tea theanine, γ-aminobutyric acid, poria cocos extract, lily extract, and barley red yeast rice fermentation product to the mixture, and homogenize to obtain the first solution;

[0052] Add the first solution to the acidic base, along with sucralose, potassium sorbate, and vitamin C;

[0053] The composition is obtained by adjusting the volume, filtering, and sterilizing.

[0054] In some embodiments of the present invention, the temperature of the pure water is 60-70°C.

[0055] Thirdly, the present invention provides the application of the above-described composition, which can be used in the field of functional foods and has the effect of promoting sleep and prolonging deep sleep.

[0056] The above is a detailed description of the present invention, and the following are embodiments of the present invention.

[0057] Example 1

[0058] In this embodiment, an oral liquid 1 is provided to promote sleep onset and prolong deep sleep. A single dose of 30 mL of oral liquid is provided.

[0059] Raw materials and dosage:

[0060] Active ingredients: Ziziphus jujuba seed extract (total saponins ≥3.0%) 50mg, γ-aminobutyric acid (purity ≥98%) 300mg, tea theanine (purity ≥98%) 50mg, prune concentrate (soluble solids ≥65°Brix) 150mg, Poria cocos extract (total polysaccharides ≥70%) 50mg, lily extract (total polysaccharides ≥50%) 50mg, highland barley red yeast rice fermentation product 2mg (lovastatin ≥0.2%).

[0061] Functional excipients: Erythritol 600mg, Sucralose 6mg, Citric Acid 60mg, Malic Acid 30mg

[0062] Stabilizing components: xanthan gum 15mg, potassium sorbate 15mg.

[0063] Antioxidant: Vitamin C 100mg.

[0064] Preparation method:

[0065] 1. Mix prune concentrate (soluble solids ≥ 65°Brix) with citric acid and malic acid at 45°C and stir for 10 minutes to form a sour base.

[0066] 2. After dry mixing xanthan gum and erythritol, add them to pure water at 65°C and disperse them at high speed of 10,000 rpm for 15 minutes to obtain a mixture;

[0067] 3. Add 2 mg of jujube seed extract (total saponins ≥3.0%), theanine (purity ≥98%), γ-aminobutyric acid (purity ≥98%), poria cocos extract (total polysaccharide ≥70%), lily extract (total saponins ≥1.5%), and barley red yeast rice fermentation product (lovastatin ≥0.2%) to the mixture obtained in step 2 to obtain the first solution. Homogenize the first solution three times under a pressure of 25 MPa.

[0068] 4. Mix the acidic base material obtained in step 1 with the first solution obtained in step 3, add sucralose, potassium sorbate, and vitamin C, and stir for 30 minutes;

[0069] 5. Adjust the volume to 30 ml, filter through a 0.22 μm filter membrane, sterilize at 121 °C for 15 minutes, and fill into brown glass bottles to obtain oral liquid 1.

[0070] Example 2

[0071] In this embodiment, a tablet that promotes sleep onset and prolongs deep sleep is provided. A single-dose 550mg tablet is provided.

[0072] Raw materials and dosage:

[0073] Active ingredients: Ziziphus jujuba seed extract (total saponins ≥3.0%) 45mg, γ-aminobutyric acid (purity ≥98%) 280mg, theanine (purity ≥98%) 55mg, prune concentrate (soluble solids ≥65°Brix) 100mg, Poria cocos extract (total polysaccharides ≥70%) 60mg, lily extract (total polysaccharides ≥50%) 40mg, highland barley red yeast rice fermentation product (lovastatin ≥0.2%) 1mg.

[0074] Functional excipients: erythritol 580mg, sucralose 4mg, citric acid 40mg, malic acid 20mg.

[0075] Stabilizing components: xanthan gum 10mg, potassium sorbate 10mg.

[0076] Tableting excipient: magnesium stearate 5.5 mg (1%).

[0077] Preparation method:

[0078] 1. Prepare the mixed solution according to steps 1-4 of Example 1.

[0079] 2. Spray drying: Inlet air temperature 160℃, outlet air temperature 80℃, to obtain powder (moisture ≤5%).

[0080] 3. Tableting: The powder is mixed with magnesium stearate. The tablets were compressed using a mold, with a tablet weight of 550±10mg and a hardness of 50N, to obtain tablets.

[0081] Example 3

[0082] In this embodiment, an oral liquid 2 is provided to promote sleep onset and prolong deep sleep. A single dose of 30 mL of oral liquid is provided.

[0083] The raw materials and dosages are as follows.

[0084] Active ingredients: Ziziphus jujuba seed extract (total saponins ≥3.0%) 60mg, γ-aminobutyric acid (purity ≥98%) 320mg, theanine (purity ≥98%) 45mg, prune concentrate (soluble solids ≥65°Brix) 200mg, Poria cocos extract (total polysaccharides ≥70%) 40mg, lily extract (total saponins ≥1.5%) 60mg, highland barley red yeast rice fermentation product (lovastatin ≥0.2%) 1mg.

[0085] Excipients and stabilizers: erythritol 620mg, sucralose 8mg, citric acid 80mg, malic acid 40mg, xanthan gum 20mg, potassium sorbate 20mg, vitamin C 120mg.

[0086] The preparation method is as described in Example 1, resulting in oral liquid 2.

[0087] Experiment Example 1: Sleep Improvement Effect Trial

[0088] 1.1 Experimental Design

[0089] Participants: 90 insomnia patients aged 18-55 (PSQI score ≥10) were recruited and randomly divided into 3 groups of 30 people each, with an even distribution of age and gender.

[0090] Group A received the formulation of Example 1.

[0091] Group B patients took the formulation of Example 2.

[0092] Group C received a placebo (n=30).

[0093] The placebo had the same appearance and taste as the formulation in Example 1. The placebo sample did not contain active ingredients such as jujube seed extract, γ-aminobutyric acid, tea theanine, poria cocos extract, lily extract, prune concentrate, and barley red yeast rice fermentation product; these ingredients were replaced with maltodextrin in equal amounts. The placebo retained all functional excipients, including erythritol, sucralose, citric acid, malic acid, xanthan gum, potassium sorbate, and vitamin C, and the color was adjusted by adding food coloring, ultimately making it completely identical to the experimental formulation in appearance, color, taste, packaging, and user experience.

[0094] Dosage instructions: Take the same dose orally one hour before bedtime for 28 consecutive days, and wear the same device to monitor sleep patterns.

[0095] Testing method: The duration of deep sleep and light sleep was continuously monitored using a Huawei Watch GT3 Pro (this device is FDA 510(K) certified (K210896)). Data from the baseline period (7 days) and the intervention period (days 21-28) were compared. The results are shown in Table 1.

[0096] 1.2 Test Results

[0097] Table 1

[0098]

[0099] 1.3 Experimental Conclusions

[0100] As can be seen from the data in Table 1, the proportion of people in Group A and Group B who took the preparations of Example 1 and Example 2 increased by more than 19.5%.

[0101] Compared with the 2.1% increase in the control group C who took the placebo, it can be seen that taking the composition formulation of the present invention can significantly increase the proportion of deep sleep (the increase is greater than 15%) and reduce the proportion of light sleep.

[0102] That is, the composition of the present invention does indeed have the effect of improving sleep quality, promoting sleep onset, and prolonging deep sleep.

[0103] Experiment Example 2 Stability Test

[0104] 2.1 Experimental Design

[0105] Oral liquid 1 from Example 1 and tablets from Example 2 were taken and placed at a temperature of 40℃±2℃ and a relative humidity of 75%±5% for 6 months. Samples were taken at 0 months, 3 months, and 6 months to detect the retention rates of γ-aminobutyric acid and theanine, as well as the microbial limits in the formulations. The test results are shown in Table 2.

[0106] 2.2 Test Results

[0107] Table 2

[0108] Sample Time GABA Retention Rate Theanine Retention Rate Microbial Limit 0 month 100.0％ 100.0％ Pass Example 1 3 months 98.2％±0.3％ 97.5％±0.5％ Pass 6 months 95.7％±0.6％ 94.1％±0.7％ Pass 0 month 100.0％ 100.0％ Pass Example 2 3 months 97.8％±0.4％ 96.3％±0.6％ Pass 6 months 94.9％±0.8％ 93.2％±0.9％ Pass

[0109] 2.3 Experimental Conclusions

[0110] Referring to the data in Table 2, it can be seen that the formulations of Examples 1 and 2 maintained high γ-aminobutyric acid and theanine retention rates and met the acceptable microbial limits in the third and sixth months.

[0111] This demonstrates that the compositions of the present invention, through a stable compounding system, can effectively maintain component stability and safety.

[0112] Experimental Example 3. Synergistic Effect Experiment

[0113] 3.1 Laboratory Animals and Materials

[0114] Animals: Clean-grade ICR healthy male mice, weighing 18g-22g, were randomly grouped after 7 days of acclimatization.

[0115] Test substances: γ-aminobutyric acid (purity ≥98%), tea theanine (purity ≥98%), and jujube seed saponin extract (total saponins ≥3.0%).

[0116] Reagents: sodium pentobarbital, 0.5% sodium carboxymethyl cellulose (CMC-Na) solution.

[0117] 3.2 Grouping and Dosing

[0118] Grouping: A blank control group, single groups, pairwise combination groups, and three-group combination groups were set up, with 10 mice in each group.

[0119] Dosage:

[0120] GABA group: 100mg / kg

[0121] Theanine group: 16.7 mg / kg

[0122] Jujube seed saponins group: 16.7 mg / kg

[0123] Compound group: according to the above dosage combination

[0124] Experimental methods:

[0125] Mice in each group were administered the corresponding test substance (dissolved in 0.5% CMC-Na) or an equal volume of solvent by gavage at the same time each day for 14 consecutive days. Forty-five minutes after the last administration, all mice were intraperitoneally injected with a subthreshold hypnotic dose (35 mg / kg) of sodium pentobarbital solution.

[0126] 3.3 Detection Indicators and Methods

[0127] Sleep rate: The percentage of animals whose righting reflex has been absent for more than 1 minute.

[0128] Sleep latency: the time (s) required from injection of sodium pentobarbital to the disappearance of the righting reflex in mice.

[0129] Sleep duration: The time (min) required for the righting reflex to disappear and return in mice.

[0130] 3.4 Experimental Results

[0131] 3.4.1 Impact on sleep onset rate

[0132] The results are shown in Table 3. Compared with the blank control group, the sleep onset rate of each single group was improved to some extent, but the difference was not statistically significant (p>0.05). The effect of the pairwise combination groups was enhanced, with the GABA+jujube seed saponin group showing a significant difference (p<0.05). The three-component combination group had the highest sleep onset rate, reaching 90%, and the difference was highly significant compared with the blank control group and all single groups (p<0.01).

[0133] The differences were highly significant (p<0.01).

[0134] Table 3 Comparison of sleep rates among different groups of mice (n=10)

[0135] Group Dose (mg / kg) Number of Sleeping Sleeping Rate (%) Blank Control - 1 10％ GABA 100 2 20％ Theanine 16.7 2 20％ Solanum acinacifolium Saponin 16.7 3 30％ GABA + Theanine 100+16.7 4 40％ GABA + Solanum acinacifolium Saponin 100+16.7 5 50％* Theanine + Solanum acinacifolium Saponin 16.7+16.7 4 40％ Three-component Compound Group 100+16.7+16.7 9 90％**

[0136] Note: * indicates a significant difference compared to the blank control group (p<0.05), ** indicates an extremely significant difference compared to the blank control group (p<0.01).

[0137] **The difference between this group and the blank control group was extremely significant (p<0.01).

[0138] 3.4.2 Effects on sleep latency and duration

[0139] The results are shown in Table 4. The three-component combination group had the shortest sleep latency and the longest sleep duration, and the differences were highly significant compared with the blank control group and all other groups (p<0.01).

[0140] Table 4 Comparison of sleep latency and duration in mice of different groups (n=10, Mean±SD)

[0141] Group Sleep Latency (s) Sleep Duration (min) Blank Control 512.3±78.9 65.8±15.2 GABA 468.5±82.4 78.3±16.5 Theanine 476.2±75.1 75.9±14.8 Solanum acinacifolium Saponin 452.8±69.5 82.1±17.0 GABA + Theanine 398.4±61.2* 95.6±18.4** GABA + Solanum acinacifolium Saponin 365.7±58.3** 102.5±19.1** Theanine + Solanum acinacifolium Saponin 376.9±60.1** 98.7±17.8** Three-component Compound Group 285.6±45.8** 125.4±20.3**

[0142] Note: * indicates a significant difference compared to the blank control group (p<0.05), ** indicates an extremely significant difference compared to the blank control group (p<0.01).

[0143] The results above show that the combined use of GABA (100 mg / kg), tea theanine (16.7 mg / kg), and jujube seed saponins (16.7 mg / kg) can significantly improve the sleep onset rate, shorten the sleep latency, and prolong the sleep duration in mice induced by subthreshold doses of sodium pentobarbital. Its effect is significantly better than that of each single component or the combination of two components.

[0144] The above are merely preferred embodiments of the present invention. It should be noted that the above preferred embodiments should not be considered as limitations on the present invention, and the scope of protection of the present invention should be determined by the scope defined in the claims. For those skilled in the art, several improvements and modifications can be made without departing from the spirit and scope of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A composition that promotes sleep onset and prolongs deep sleep, characterized in that, The composition, by weight parts, comprises: 40-60 parts of jujube seed extract, 280-320 parts of γ-aminobutyric acid, 45-55 parts of tea theanine, 40-60 parts of Poria cocos extract, and 40-60 parts of lily extract.

2. The composition for promoting sleep onset and prolonging deep sleep according to claim 1, characterized in that, The composition, by weight, also includes flavoring agents and functional agents.

3. The composition for promoting sleep onset and prolonging deep sleep according to claim 2, characterized in that, The flavoring ingredients, by weight, include 580-620 parts erythritol, 4-8 parts sucralose, 40-80 parts citric acid, 20-40 parts malic acid, and 100-200 parts prune concentrate.

4. The composition for promoting sleep onset and prolonging deep sleep according to claim 2, characterized in that, The functional excipients, by weight, include 10-20 parts xanthan gum, 10-20 parts potassium sorbate, 80-120 parts vitamin C, and 1-3 parts highland barley red yeast fermentation product.

5. The composition for promoting sleep onset and prolonging deep sleep according to claim 1, characterized in that, The total saponins in the jujube seed extract have a mass percentage greater than 3.0% on a dry weight basis.

6. The composition for promoting sleep onset and prolonging deep sleep according to claim 1, characterized in that, The lily extract contains more than 50% polysaccharides by weight, on a dry weight basis.

7. The composition for promoting sleep onset and prolonging deep sleep according to claim 1, characterized in that, The extract of Poria cocos contains polysaccharides at a mass percentage greater than 70% on a dry weight basis.

8. A method for preparing a composition for promoting sleep onset and prolonging deep sleep as described in any one of claims 1 to 7, characterized in that, Includes the following steps: Take the raw materials according to the formula, and mix prune concentrate, citric acid and malic acid to obtain the sour base; Xanthan gum and erythritol were dry-mixed and then added to pure water, and dispersed by high-speed shearing to obtain a mixture. Add jujube seed extract, tea theanine, γ-aminobutyric acid, poria cocos extract, lily extract, and barley red yeast rice fermentation product to the mixture, and homogenize to obtain the first solution; Add the first solution to the acidic base, along with sucralose, potassium sorbate, and vitamin C; The composition is obtained by adjusting the volume, filtering, and sterilizing.

9. A method for preparing a composition for promoting sleep onset and prolonging deep sleep according to claim 1, characterized in that, The temperature of the pure water is 60–70°C.

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