Use of a multi-active composition in the manufacture of a health care product for improving brain fatigue, sleep quality

Abstract

The application discloses application of a multi-activity composition in preparation of health care products for improving brain fatigue and sleep quality, and belongs to the technical field of health care food. The multi-activity composition comprises, in terms of weight parts, 8-25 parts of an extract of Spartium juniperrum L., 5-20 parts of an extract of Polygonatum sibiricum, 3-12 parts of an extract of Zizyphus jujuba, 2-10 parts of gamma-aminobutyric acid, 1-6 parts of L-theanine, 0.5-3 parts of a magnesium salt and 0.05-0.3 parts of a vitamin B6 derivative. The composition can be used for preparing health care products for improving brain fatigue and sleep quality through multi-target point synergy of plant-derived antioxidant components and neurotransmitter regulating components.

Description

Technical Field

[0001] This invention belongs to the field of health food technology, and specifically relates to the application of a multi-active composition in the preparation of health products that improve brain fatigue and sleep quality. Background Technology

[0002] With the fast pace of modern life and increasing work pressure, mental fatigue and declining sleep quality have become widespread health problems. Prolonged mental work, stress, and irregular sleep patterns can all lead to an imbalance between the excitability and inhibition of the cerebral cortex, manifesting as symptoms of mental fatigue such as poor concentration, memory loss, slow thinking, and mood swings, as well as sleep disorders such as difficulty falling asleep, shallow sleep, frequent awakenings, early awakenings, and fatigue upon waking. There is a causal relationship between mental fatigue and declining sleep quality: accumulated mental fatigue during the day leads to difficulty falling asleep and disrupted sleep structure at night, while insufficient sleep further exacerbates the day's mental fatigue, creating a vicious cycle.

[0003] Currently, health products on the market targeting brain fatigue and sleep problems mainly fall into two categories. One category consists of hormone-regulating products, represented by melatonin. These products regulate the biological clock by supplementing exogenous melatonin, but their target is singular, resulting in limited improvement in brain fatigue. Furthermore, long-term use may lead to dependence, and some individuals may experience residual effects such as drowsiness and dizziness the following day. The other category comprises traditional calming products with Chinese medicinal herbs such as jujube seed, lily bulb, and poria cocos as main ingredients. These products focus on calming the mind and promoting sleep, but their effect on improving brain fatigue is often not significant. Moreover, the ingredient combinations of different products are highly similar, often simply a combination of common Chinese medicinal herbs, lacking a multi-target synergistic design that addresses both brain fatigue and sleep problems.

[0004] Furthermore, while amino acid components such as γ-aminobutyric acid (GABA) and L-theanine are increasingly used in existing sleep-improving health products, these components are mostly combined with melatonin or single herbal extracts. There are currently no systematic formulations combining them with extracts from plants possessing antioxidant and neuroprotective properties. Meanwhile, magnesium and vitamin B6, as important coenzyme factors in neurotransmitter synthesis and transmission, are often overlooked or added only at standard doses in health products aimed at improving brain fatigue and sleep quality, failing to form an optimized synergistic system with other active ingredients.

[0005] Therefore, developing a multi-active composition that can simultaneously improve brain fatigue and sleep quality, exert synergistic effects through multiple components and multiple targets, and has a novel combination of components has significant market demand and application value. Summary of the Invention

[0006] In view of this, the present invention provides an application of a multi-active composition in the preparation of health products that improve brain fatigue and sleep quality, in order to solve or alleviate one of the technical problems existing in the prior art, and at least provide a beneficial alternative.

[0007] The technical solution of this invention is implemented as follows: This invention relates to the application of a multi-active composition in the preparation of health products that improve brain fatigue and sleep quality. This multi-active composition is based on seven active ingredients, and the dosage range of each component by weight is as follows: 8-25 parts of *Broomia linearifolia* extract, 5-20 parts of *Polygonatum sibiricum* extract, 3-12 parts of *Ziziphus jujuba* seed extract, 2-10 parts of γ-aminobutyric acid, 1-6 parts of L-theanine, 0.5-3 parts of magnesium salt, and 0.05-0.3 parts of vitamin B6 derivative.

[0008] In a preferred formulation, the active ingredients, by weight, can be adjusted as follows: 12-20 parts of *Broomia linearifolia* extract, 8-15 parts of *Polygonatum sibiricum* extract, 5-9 parts of *Ziziphus jujuba* seed extract, 4-8 parts of γ-aminobutyric acid (GABA), 2-4 parts of L-theanine, 1-2 parts of magnesium salt, and 0.1-0.2 parts of vitamin B6 derivative. This preferred formulation results in a more balanced synergistic effect among the components.

[0009] Regarding the content of active ingredients in each plant extract, the mass percentage of Aspalathin in the *Broomia linearis* extract is controlled at no less than 3%, the mass percentage of *Polygonatum sibiricum* polysaccharides in the *Polygonatum sibiricum* extract is no less than 30%, and the mass percentage of total saponins in the *Ziziphus jujuba* seed extract is no less than 2%. These content indicators ensure that each plant extract possesses the corresponding biological activity.

[0010] Magnesium salts can be selected from one or more combinations of magnesium malate, magnesium citrate, and magnesium glycine; vitamin B6 derivatives can be selected from one or more combinations of pyridoxal 5-phosphate, pyridoxine hydrochloride, and pyridoxine. The above-mentioned organic magnesium salts and active vitamin B6 forms exhibit good bioavailability.

[0011] Health products prepared from this multi-active composition can be made into various dosage forms, including tablets, capsules, granules, oral liquids, or solid beverages, to suit the consumption habits and needs of different groups of people.

[0012] The preparation of this multi-active composition employs a stepwise mixing process: first, three plant-derived powders—extracts of *Broomia linearifolia*, *Polygonatum sibiricum*, and *Ziziphus jujuba*—are added to a mixing device and mixed at 15–25 rpm for 10–20 minutes to obtain a homogeneous first mixture; then, γ-aminobutyric acid (GABA), L-theanine, magnesium salts, and a vitamin B6 derivative are added to the first mixture, and mixing continues at 20–30 rpm for 15–25 minutes to obtain a second mixture; finally, the second mixture is subjected to granulation, drying, and sizing processes to obtain the finished multi-active composition granules. This stepwise mixing method facilitates the uniform dispersion of trace active ingredients in a large amount of plant powder.

[0013] When preparing health supplements, pharmaceutically acceptable excipients may be added according to dosage form requirements, such as one or more of microcrystalline cellulose, crospovidone, magnesium stearate, silicon dioxide, maltodextrin, and steviol glycosides, to improve the product's formability, flowability, and taste.

[0014] The recommended daily intake of this health supplement is 0.5 to 3 grams of the multi-active compound. The specific dosage can be adjusted according to the product formulation and target population.

[0015] The embodiments of the present invention have the following advantages due to the adoption of the above technical solutions: First, this invention, through the combination of extracts from *Broomia linearis* and *Polygonatum sibiricum*, effectively improves brain fatigue from both antioxidant and energy metabolism perspectives. *Broomia linearis* extract contains flavonoids such as aspalathin, which have antioxidant activity and can help reduce oxidative stress damage to nerve cells; *Polygonatum sibiricum* extract contains polysaccharides with anti-fatigue and immunomodulatory effects, which can help improve fatigue after mental work. The combination of these two plant extracts can synergistically improve brain fatigue symptoms through different pathways.

[0016] Secondly, this invention utilizes a five-component combination of jujube seed extract, γ-aminobutyric acid (GABA), L-theanine, magnesium salts, and vitamin B6 derivatives to improve sleep quality from multiple neuromodulatory targets. Total saponins from jujube seed can help prolong sleep time and improve sleep depth; GABA, as an inhibitory neurotransmitter, can help reduce nerve excitability and shorten sleep latency; L-theanine can help induce alpha brain waves, relaxing the mind without causing drowsiness; magnesium salts participate in the functional regulation of GABA receptors, helping to enhance inhibitory neurotransmission; and vitamin B6 derivatives, as coenzyme factors in the synthesis of serotonin and dopamine, can help regulate neurotransmitter balance. The synergistic effect of these five components covers multiple aspects, including sleep onset, sleep maintenance, and sleep quality improvement.

[0017] Third, the multi-active composition of this invention systematically integrates components that improve brain fatigue and components that improve sleep, which can help break the vicious cycle between brain fatigue and sleep disorders. When taken during the day, the plant-derived antioxidant and anti-fatigue components can help maintain brain alertness and reduce mental fatigue; when taken at night, the neurotransmitter regulating components can help promote natural sleep and improve sleep quality. The two mechanisms of action work together to achieve all-day health management that combats fatigue during the day and promotes sleep at night.

[0018] Fourth, this invention employs a specific weight ratio to enable synergistic effects among the active ingredients. The basic active framework consists of three plant components: extracts of *Broomia linearifolia*, *Polygonatum sibiricum*, and *Ziziphus jujuba* seed. Gamma-aminobutyric acid (GABA) and L-theanine act as amino acid regulators, while magnesium salts and vitamin B6 derivatives serve as coenzyme factors. The optimized ratios of these components help avoid discomfort caused by excessive amounts of a single ingredient, while simultaneously maximizing the synergistic benefits of multiple components.

[0019] Fifth, the multi-active composition of the present invention does not contain hormones such as melatonin, which helps to avoid the dependence and drowsiness problems that may result from exogenous hormone supplementation, making it suitable for long-term health care needs.

[0020] The above overview is for illustrative purposes only and is not intended to be limiting in any way. In addition to the illustrative aspects, embodiments, and features described above, further aspects, embodiments, and features of the invention will become readily apparent from the accompanying drawings and the following detailed description. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a process flow diagram for preparing the multi-active composition of the present invention.

[0023] Figure 2 This is a schematic diagram illustrating the synergistic effect of the components in the multi-active composition of the present invention. Detailed Implementation

[0024] In the following description, only certain exemplary embodiments are briefly described. As those skilled in the art will recognize, the described embodiments can be modified in various ways without departing from the spirit or scope of the invention. Therefore, the drawings and description are considered to be exemplary in nature and not restrictive.

[0025] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0026] This invention provides the application of a multi-active composition in the preparation of health products that improve brain fatigue and sleep quality. The multi-active composition is based on three plant-derived active ingredients: extracts of *Broomia linearifolia*, *Polygonatum sibiricum*, and *Ziziphus jujuba* seed, combined with four neuromodulation-related components: γ-aminobutyric acid (GABA), L-theanine, magnesium salts, and vitamin B6 derivatives, forming a seven-component synergistic multi-active composition.

[0027] The *Aspalathus linearis* extract is prepared from the leaves and tender branches of *Aspalathus linearis* (also known as Rooibos tea), a plant belonging to the genus *Aspalathus* of the Fabaceae family, through water or alcohol extraction, concentration, and drying. The *Aspalathus linearis* extract contains unique dihydrochalcone flavonoids such as aspalathin and nothofagin, as well as flavonoids such as quercetin and luteolin. Aspalathin is a unique active ingredient in *Aspalathus linearis*, possessing antioxidant, anti-inflammatory, and metabolic regulatory biological activities. In this invention, the mass percentage of aspalathin in the *Aspalathus linearis* extract is not less than 3%, preferably 3%–8%. The weight parts of the *Aspalathus linearis* extract in the composition are 8–25 parts, preferably 12–20 parts.

[0028] The Polygonatum extract is prepared from the dried rhizomes of Polygonatum sibiricum, Polygonatum kingianum, or Polygonatum cyrtonema (all belonging to the genus Polygonatum in the family Liliaceae), through water extraction, concentration, alcohol precipitation, and drying. The main active ingredient of the Polygonatum extract is Polygonatum polysaccharide, a water-soluble polysaccharide composed of monosaccharides such as fructose and glucose. Polygonatum polysaccharide possesses biological activities such as anti-fatigue, antioxidant, immunomodulatory, and neuroprotective effects. In this invention, the mass percentage of Polygonatum polysaccharide in the Polygonatum extract is not less than 30%, preferably 30%–60%. The weight parts of the Polygonatum extract in the composition are 5–20 parts, preferably 8–15 parts.

[0029] The jujube seed extract is prepared from the dried, mature seeds of *Ziziphus jujuba* var. *spinosa*, a plant belonging to the Rhamnaceae family, through alcohol or water extraction, concentration, and drying. The main active components of the jujube seed extract are triterpenoid saponins such as jujube seed saponin A and jujube seed saponin B, as well as flavonoids such as spinosin and scutellarin. Total jujube seed saponins possess sedative, tranquilizing, and sleep-improving biological activities. In this invention, the total jujube seed saponin content in the jujube seed extract is not less than 2% by weight, preferably 2%–5%. The jujube seed extract constitutes 3–12 parts by weight in the composition, preferably 5–9 parts.

[0030] The aforementioned γ-aminobutyric acid (GABA) is a non-protein amino acid that functions as an important inhibitory neurotransmitter in the central nervous system. GABA can bind to GABA receptors on neuronal membranes, causing chloride ion influx, leading to neuronal hyperpolarization, thereby reducing nerve excitability and producing sedative, anti-anxiety, and sleep-promoting effects. In this invention, the weight parts of γ-aminobutyric acid in the composition are 2 to 10 parts, preferably 4 to 8 parts.

[0031] L-Theanine, chemically known as N-ethyl-γ-L-glutamine, is a non-protein amino acid unique to tea. L-Theanine can cross the blood-brain barrier, influencing the metabolism of neurotransmitters in the brain, promoting the generation of alpha brain waves, and inducing a relaxed yet alert state. It also relieves mental stress and improves sleep quality. Unlike sedative ingredients, L-Theanine does not cause drowsiness or decreased attention while producing a relaxing effect. In this invention, the L-Theanine content in the composition is 1 to 6 parts by weight, preferably 2 to 4 parts.

[0032] The magnesium salt is at least one of magnesium malate, magnesium citrate, and magnesium glycine. Magnesium is an important mineral element in the human body, participating in various enzymatic reactions. In the nervous system, magnesium ions can regulate the function of N-methyl-D-aspartate (NMDA) receptors and γ-aminobutyric acid receptors, playing an important role in controlling nerve excitability. Magnesium deficiency is associated with symptoms such as insomnia, anxiety, and fatigue. This invention uses an organic magnesium salt form, which has good bioavailability and gastrointestinal tolerance. The magnesium salt in the composition is 0.5 to 3 parts by weight, preferably 1 to 2 parts.

[0033] The vitamin B6 derivative is at least one of pyridoxal 5-phosphate, pyridoxine hydrochloride, and pyridoxine. Vitamin B6 participates in various amino acid metabolic reactions in vivo in its active form, pyridoxal 5-phosphate, and is an important coenzyme in the synthesis of neurotransmitters such as serotonin, dopamine, and γ-aminobutyric acid. Vitamin B6 deficiency can lead to mood swings, sleep disorders, and fatigue. In this invention, the vitamin B6 derivative is present in the composition at a weight of 0.05–0.3 parts, preferably 0.1–0.2 parts.

[0034] The present invention will be further described in detail below with reference to specific embodiments.

[0035] Example 1

[0036] This embodiment provides a multi-active composition comprising the following components by weight: 15 parts of *Broomia linearifolia* extract (4.2% Aspalathin content), 10 parts of *Polygonatum sibiricum* extract (45% *Polygonatum sibiricum* polysaccharide content), 6 parts of *Ziziphus jujuba* seed extract (3.1% total saponins of *Ziziphus jujuba* seed), 5 parts of γ-aminobutyric acid, 3 parts of L-theanine, 1.5 parts of magnesium malate, and 0.15 parts of pyridoxal 5-phosphate.

[0037] like Figure 1 As shown, the multi-active composition of this embodiment is prepared through the following steps: Step 1: Weigh the extracts of *Broomia linearifolia* (feed 1), *Polygonatum sibiricum* (feed 2), and *Ziziphus jujuba* (feed 3) separately, and add them to the first mixing unit 8. Mix for 15 minutes at 20 rpm to ensure the three plant extracts are thoroughly mixed, resulting in the first mixture. Premixing the three plant extracts helps to form a uniform matrix of plant powders with similar density and particle size, providing a uniform dispersion carrier for the subsequent addition of small molecule components.

[0038] Step two: γ-aminobutyric acid feed 4, L-theanine feed 5, magnesium salt feed 6, and vitamin B6 derivative feed 7 are weighed separately and added to the second mixing unit 9 containing the first mixture. The mixture is then mixed for 20 minutes at 25 rpm to ensure uniform dispersion of the small molecule active ingredients within the plant extract matrix, yielding the second mixture. This stepwise mixing method helps avoid uneven mixing of trace components (such as pyridoxal 5-phosphate) in a large quantity of powder.

[0039] Step 3: The second mixture is fed into the granulation unit 10 and granulated using a dry granulation or wet granulation process. Then it is fed into the drying unit 11 and dried at 40-50°C until the moisture content does not exceed 5%. Then it is fed into the granulation unit 12 and granulated through a 20-mesh sieve. Finally, it is collected by the finished product collection 13 to obtain multi-active composition granules.

[0040] The multi-active composition granules prepared in this embodiment are mixed with appropriate amounts of microcrystalline cellulose, crospovidone, and magnesium stearate, and then compressed into tablets, each containing 0.8 grams of the multi-active composition. These tablets can be used as a health product to improve brain fatigue and sleep quality; it is recommended to take 1-2 tablets daily.

[0041] Example 2

[0042] This embodiment provides a multi-active composition comprising the following components by weight: 18 parts of *Gynostemma pentaphyllum* extract (containing 5.0% Aspalathin), 12 parts of *Polygonatum sibiricum* extract (containing 50% *Polygonatum sibiricum* polysaccharide), 8 parts of *Ziziphus jujuba* seed extract (containing 2.8% total saponins from *Ziziphus jujuba* seed), 7 parts of γ-aminobutyric acid, 4 parts of L-theanine, 2 parts of magnesium citrate, and 0.2 parts of pyridoxine hydrochloride.

[0043] The preparation method of the multi-active composition in this embodiment is basically the same as that in Example 1, except that: in step one, the rotation speed of the first mixing unit is 18 rpm and the mixing time is 18 minutes; in step two, the rotation speed of the second mixing unit is 28 rpm and the mixing time is 22 minutes.

[0044] The multi-active composition granules prepared in this embodiment are encapsulated in hard capsules, each containing 0.5 grams of the multi-active composition. This capsule can be used as a health product to improve brain fatigue and sleep quality; it is recommended to take 2-3 capsules daily.

[0045] Example 3

[0046] This embodiment provides a multi-active composition comprising the following components by weight: 12 parts of *Gynostemma pentaphyllum* extract (Aspalathin content 3.5%), 8 parts of *Polygonatum sibiricum* extract (Polygonatum sibiricum polysaccharide content 35%), 5 parts of *Ziziphus jujuba* seed extract (total saponin content of *Ziziphus jujuba* seed 2.2%), 4 parts of γ-aminobutyric acid, 2 parts of L-theanine, 1 part of magnesium glycine, and 0.1 parts of pyridoxal 5-phosphate.

[0047] The preparation method of the multi-active composition in this embodiment is basically the same as that in Example 1, except that: in step one, the rotation speed of the first mixing unit is 22 rpm and the mixing time is 12 minutes; in step two, the rotation speed of the second mixing unit is 22 rpm and the mixing time is 16 minutes.

[0048] The multi-active composition granules prepared in this embodiment are mixed with appropriate amounts of maltodextrin and steviol glycosides, and then packaged into a solid beverage, with each sachet containing 1.0 gram of the multi-active composition. This solid beverage can be used as a health product to improve brain fatigue and sleep quality. It is recommended to take one sachet daily, dissolved in warm water.

[0049] Example 4

[0050] This embodiment provides a multi-active composition comprising the following components by weight: 20 parts of *Gynostemma pentaphyllum* extract (Aspalathin content 6.0%), 15 parts of *Polygonatum sibiricum* extract (Polygonatum sibiricum polysaccharide content 55%), 9 parts of *Ziziphus jujuba* seed extract (total saponins content 4.0%), 8 parts of γ-aminobutyric acid, 5 parts of L-theanine, 2.5 parts of magnesium malate, and 0.25 parts of pyridoxal 5-phosphate.

[0051] The preparation method of the multi-active composition in this embodiment is the same as that in Example 1. The multi-active composition obtained in this embodiment is mixed with appropriate amounts of purified water, honey, and citric acid to prepare an oral liquid. Each 10 ml vial contains 1.5 g of the multi-active composition. This oral liquid can be used as a health product to improve brain fatigue and sleep quality; it is recommended to take one vial daily.

[0052] Comparative Example 1

[0053] This comparative example provides a composition that differs from Example 1 only in that it does not contain *Broomia linearis* extract; all other components and amounts are the same as in Example 1. This comparative example is used to illustrate the role of *Broomia linearis* extract in the composition. The absence of *Broomia linearis* extract reduces the antioxidant activity in the composition, and its effect on improving brain fatigue-related oxidative stress damage is expected to be weakened.

[0054] Comparative Example 2

[0055] This comparative example provides a composition that differs from Example 1 only in that it does not contain Polygonatum sibiricum extract; all other components and amounts are the same as in Example 1. This comparative example is used to illustrate the role of Polygonatum sibiricum extract in the composition. Without Polygonatum sibiricum extract, the anti-fatigue polysaccharide component in the composition is missing, and its effect on improving fatigue after mental work is expected to be weakened.

[0056] Comparative Example 3

[0057] This comparative example provides a composition that differs from Example 1 only in that it does not contain jujube seed extract; all other components and amounts are the same as in Example 1. This comparative example is used to illustrate the role of jujube seed extract in the composition. Without jujube seed extract, the plant-derived sedative and calming components in the composition are reduced, and the expected improvement in sleep depth and duration is weakened.

[0058] Comparative Example 4

[0059] This comparative example provides a composition that differs from Example 1 only in that it does not contain magnesium salts and vitamin B6 derivatives; all other components and amounts are the same as in Example 1. This comparative example is used to illustrate the synergistic effect of magnesium salts and vitamin B6 derivatives in the composition as coenzymes. The absence of these two coenzyme factors is expected to affect the efficacy of neurotransmitter regulatory components such as γ-aminobutyric acid (GABA) and L-theanine.

[0060] Efficacy verification comparative experiment

[0061] To verify the indispensability of each component and the synergistic effect of the high-ratio composition in Example 4, a chronic sleep deprivation + mental stress-induced brain fatigue mouse model was uniformly used, and the mice were divided into the following groups: blank group, Example 1, Example 4, and Comparative Examples 1 to 4. The dosage, administration period (30 days), breeding environment, and detection methods were completely consistent for each group. Four core indicators were evaluated: sleep regulation ability, brain nerve antioxidant damage, mental fatigue recovery, and neurotransmitter levels.

[0062] Sleep regulation performance test results

[0063] The sodium pentobarbital hypnosis experiment was used to analyze the sleep latency, duration of sleep, sleep onset rate, and GABA content in the hypothalamus of mice. The results are shown in the table below:

[0064] Brain fatigue and antioxidant damage test results

[0065] The Morris water maze was used to evaluate brain recovery ability and detect brain tissue antioxidant indicators SOD and oxidative damage products MDA, which directly reflect the brain's ability to repair oxidative stress.

[0066]

[0067] Experimental Results Analysis and Component Function Demonstration

[0068] 1. Analysis of the synergistic advantages of Example 4

[0069] Compared to Example 1, Example 4 significantly increases the proportions and content of each core active extract and functional excipient, and also has higher purity of active ingredients. Data shows that Example 4 can further shorten sleep latency, prolong deep sleep time, significantly improve brain tissue antioxidant capacity and memory recovery level, and has the best overall effect in improving brain fatigue and sleep quality, proving that increasing the reasonable proportions and concentrations of each active component can achieve a significant dose-synergistic effect; at the same time, the oral liquid dosage form is absorbed faster and has a better onset of action, showing better application prospects.

[0070] 2. Conclusions of the control group for missing components

[0071] (1) Functional verification of *Broomia linearis* extract (Comparative Example 1): Without *Broomia linearis* extract, the composition exhibited a significant decrease in SOD antioxidant activity, a significant increase in MDA oxidative damage accumulation, a marked decline in brain fatigue repair capacity, and a significant reduction in sleep improvement effect. This demonstrates that the high-purity Aspalathin abundant in *Broomia linearis* extract is the core antioxidant active substance, which can specifically scavenge brain nerve free radicals and alleviate brain oxidative stress damage. It is a key component of the composition of this invention for anti-brain fatigue and repairing brain nerve damage, and also possesses auxiliary sedative and tranquilizing effects, making it indispensable.

[0072] (2) Functional verification of Polygonatum extract (Comparative Example 2): After removing Polygonatum extract, the latency period of escape in the water maze of mice was significantly prolonged, the spatial memory recovery ability was reduced, and persistent mental fatigue was difficult to relieve. It is confirmed that high content of Polygonatum polysaccharide can effectively nourish brain nerves, improve brain energy metabolism, and repair long-term mental exhaustion damage. It is the core functional component of the composition for long-term relief of mental fatigue and improvement of mental weakness and lethargy.

[0073] (3) Functional verification of jujube seed extract (comparative example 3): This group showed the greatest decline in efficacy. After the absence of total jujube seed saponins, the mice experienced a significant decrease in sleep onset rate, a significant shortening of sleep duration, a significant prolongation of sleep latency, and a significant reduction in the synthesis of the central inhibitory neurotransmitter GABA. This demonstrates that jujube seed extract is the exclusive core component of the composition for calming the nerves, improving sleep depth, and prolonging effective sleep time, and has a strong and irreplaceable role in sleep regulation.

[0074] (4) Synergistic verification of magnesium salt + pyridoxal 5-phosphate (Comparative Example 4): After the absence of magnesium salt and vitamin B6 derivative, the amount of GABA synthesis decreased significantly, and the overall effects of sleep aid and anti-fatigue were significantly weakened. It was verified that the two types of components are key coenzyme factors in the synthesis of neurotransmitters, which can significantly activate the neuroregulatory activity of γ-aminobutyric acid and L-theanine, play a role in enhancing efficacy and synergistically amplifying the overall effect, and are an important part of the synergistic system of the formulation.

[0075] like Figure 2As shown, there is a synergistic effect among the components in the multi-active composition of the present invention. The extracts of *Broomia linearifolia* and *Polygonatum sibiricum* primarily act on the brain fatigue improvement pathway, exerting their effects through antioxidant and energy metabolism regulation, respectively. The extracts of *Ziziphus jujuba* seed, γ-aminobutyric acid (GABA), L-theanine, magnesium salts, and vitamin B6 derivatives primarily act on the sleep quality improvement pathway, exerting their effects through different targets such as sedation, supplementation of inhibitory neurotransmitters, α-wave induction, receptor function regulation, and coenzymes for neurotransmitter synthesis. The two pathways form a mutually reinforcing relationship through the overall regulation of the nervous system: reducing brain fatigue helps lower pre-sleep neural excitability, thereby improving sleep conditions; improving sleep quality facilitates brain rest and recovery, thereby reducing the degree of brain fatigue the following day. Magnesium salts and vitamin B6 derivatives, as coenzyme factors, participate in multiple enzymatic reactions in both pathways, acting as a bridge and enhancer between them.

[0076] When preparing health products, the multi-active composition of the present invention can be supplemented with pharmaceutically acceptable excipients as needed. These excipients include, but are not limited to, fillers (such as microcrystalline cellulose, lactose, starch, maltodextrin), disintegrants (such as crospovidone, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose), lubricants (such as magnesium stearate, silica, talc), flavoring agents (such as steviol glycosides, sucralose, natural flavorings), colorants, and coating materials. The type and amount of excipients are selected according to the dosage form to ensure that the product has good appearance, taste, and stability.

[0077] The multi-active composition of this invention can be formulated into various dosage forms when preparing health products, including but not limited to tablets (conventional tablets, chewable tablets, effervescent tablets, sustained-release tablets), capsules (hard capsules, soft capsules), granules, oral liquids, solid beverages, pills, and powders. Different dosage forms are suitable for different consumption scenarios and population needs. For example, tablets and capsules are convenient to carry and take in measured amounts, while oral liquids and solid beverages are convenient for people with swallowing difficulties.

[0078] When preparing health products, the recommended daily intake of the multi-active composition of the present invention is 0.5–3 grams, preferably 1–2 grams. The specific dosage can be adjusted according to the product formulation, target population, and individual differences. Regarding the timing of administration, it can be taken after lunch to help improve daytime mental fatigue, or after dinner until 30 minutes before bedtime to help improve nighttime sleep quality, or it can be taken in two divided doses as needed.

[0079] It should be noted that the multi-active composition of this invention falls under the category of health food and cannot replace drug treatment. Individuals suffering from severe sleep disorders or chronic fatigue syndrome should use it under the guidance of a physician. Pregnant women, breastfeeding women, and children should consult a professional before use. This invention is contraindicated in individuals with known hypersensitivity to any component of the composition.

[0080] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various variations or substitutions within the technical scope disclosed in the present invention, and these should all be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. The application of a multi-active composition in the preparation of health products that improve brain fatigue and sleep quality, characterized in that, The multi-active composition comprises the following active ingredients in parts by weight: Extracts of *Gynostemma pentaphyllum* (8-25 parts), *Polygonatum sibiricum* (5-20 parts), *Ziziphus jujuba* (3-12 parts), γ-aminobutyric acid (2-10 parts), L-theanine (1-6 parts), magnesium salt (0.5-3 parts), and vitamin B6 derivative (0.05-0.3 parts).

2. The application of the multi-active composition according to claim 1 in the preparation of health products that improve brain fatigue and sleep quality, characterized in that, The multi-active composition comprises, by weight, the following: 12-20 parts of *Gynostemma pentaphyllum* extract, 8-15 parts of *Polygonatum sibiricum* extract, 5-9 parts of *Ziziphus jujuba* seed extract, 4-8 parts of γ-aminobutyric acid, 2-4 parts of L-theanine, 1-2 parts of magnesium salt, and 0.1-0.2 parts of vitamin B6 derivative.

3. The application of the multi-active composition according to claim 1 in the preparation of health products that improve brain fatigue and sleep quality, characterized in that, The mass percentage of Aspalathin in the extract of the linear leaf broom is not less than 3%.

4. The application of the multi-active composition according to claim 1 in the preparation of health products that improve brain fatigue and sleep quality, characterized in that, The mass percentage of Polygonatum polysaccharides in the Polygonatum extract is not less than 30%.

5. The application of the multi-active composition according to claim 1 in the preparation of health products that improve brain fatigue and sleep quality, characterized in that, The total saponins from jujube seed extract contain no less than 2% by mass.

6. The application of the multi-active composition according to claim 1 in the preparation of health products that improve brain fatigue and sleep quality, characterized in that, The magnesium salt is at least one of magnesium malate, magnesium citrate, and magnesium glycine; the vitamin B6 derivative is at least one of pyridoxal 5-phosphate, pyridoxine hydrochloride, and pyridoxine.

7. The application of the multi-active composition according to claim 1 in the preparation of health products that improve brain fatigue and sleep quality, characterized in that, The dosage form of the health care product is tablets, capsules, granules, oral liquid, or solid beverage.

8. The application of the multi-active composition according to claim 1 in the preparation of health products that improve brain fatigue and sleep quality, characterized in that, The preparation method of the multi-active composition includes the following steps: Extracts of *Broomia linearifolia*, *Polygonatum sibiricum*, and *Ziziphus jujuba* seed were placed in a mixing device and mixed for 10-20 minutes at a speed of 15-25 rpm to obtain the first mixture. Add γ-aminobutyric acid, L-theanine, magnesium salt and vitamin B6 derivative to the first mixture, and mix for 15 to 25 minutes at a speed of 20 to 30 rpm to obtain the second mixture; The second mixture is granulated, dried and sized to obtain the multi-active composition.

9. The application of the multi-active composition according to claim 7 in the preparation of health products that improve brain fatigue and sleep quality, characterized in that, The health product also includes pharmaceutically acceptable excipients, which are at least one of microcrystalline cellulose, crospovidone, magnesium stearate, silicon dioxide, maltodextrin, and steviol glycosides.

10. The application of the multi-active composition according to claim 7 in the preparation of health products that improve brain fatigue and sleep quality, characterized in that, The daily dosage of the health product includes an intake of 0.5 to 3 grams of the multi-active composition.

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