A composition for relieving depression and tranquilizing the mind for improving sleep quality, and a preparation method and application thereof

Abstract

The application provides a sleep quality improving relieving depression and tranquilizing composition and a preparation method and application thereof, and belongs to the technical field of health products.The relieving depression and tranquilizing composition comprises traditional Chinese medicine extracts, astaxanthin, theanine, probiotics and chitosan; the traditional Chinese medicine extracts are composed of polygala extract, jujube seed extract and albizia julibrissin extract. When prepared, the chitosan is mixed with an acetic acid solution to form a solution, the traditional Chinese medicine extracts, astaxanthin and theanine are added to prepare a suspension, and the suspension is mixed with the probiotics after vacuum freeze drying. Animal experiments show that the composition can shorten the sleep latency, prolong the total sleep time, and increase the contents of 5-hydroxytryptamine and gamma-aminobutyric acid in brain tissues, and can be used for preparing sleep improvement products, and has the effects of relieving depression and tranquilizing, soothing nerves, high safety and wide applicability.

Description

Technical Field

[0001] This invention relates to the field of health product technology, specifically to a calming and mood-enhancing composition for improving sleep quality, its preparation method, and its application. Background Technology

[0002] Sleep is a core physiological process for maintaining human physical and mental health. However, with the accelerated pace of modern life and increasing pressure, the incidence of sleep disorders continues to rise, becoming a serious public health problem. Sleep disorders not only manifest as difficulty falling asleep, insufficient sleep depth, or early awakening, but are often accompanied by daytime fatigue, cognitive decline, and low mood. Furthermore, they are mutually reinforcing with anxiety, depression, and other mental and emotional problems, forming a vicious cycle of "insomnia caused by depression, and depression caused by insomnia."

[0003] Modern medicine often uses benzodiazepines or non-benzodiazepines as sedatives, but long-term use can easily lead to side effects such as drug dependence, drug tolerance, and cognitive impairment. In traditional Chinese medicine theory, sleep is closely related to emotions, and emotional distress and liver qi stagnation are among the core pathogenic mechanisms leading to insomnia. While existing Chinese herbal formulas have some calming effects, they mostly focus on a single calming or liver-soothing effect, and their overall regulatory capacity remains insufficient for the complex sleep problems caused by modern people's mental stress and disordered sleep patterns.

[0004] In recent years, the application of plant extracts and natural ingredients in improving sleep has gradually attracted attention. However, single ingredients often have limited effects and cannot fully cover the multiple causes of insomnia. In addition, existing compositions are mostly limited to traditional formulations and lack in-depth integration of modern pharmacological mechanisms. Their absorption efficiency, component stability, and dosage form adaptability also need to be optimized.

[0005] Therefore, there is an urgent need in this field for a composition for relieving depression and calming the mind based on traditional Chinese medicine theory, combined with modern pharmacological research, and achieved through optimized preparation process. This composition can improve sleep quality while regulating emotional state, achieving both symptomatic and root-cause treatment, and is characterized by high safety and wide applicability. Summary of the Invention

[0006] The purpose of this invention is to provide a calming and sedative composition for improving sleep quality, its preparation method, and its application. The calming and sedative composition provided by this invention has the effects of calming the nerves, relieving depression, soothing nerves, and improving sleep and mood.

[0007] To achieve the above-mentioned objectives, the present invention provides the following technical solution:

[0008] This invention provides a calming and soothing composition for improving sleep quality, comprising the following raw materials in parts by weight: 3-5 parts of traditional Chinese medicine extract, 3-5 parts of astaxanthin, 1-3 parts of theanine, 3-5 parts of probiotics, and 10-15 parts of chitosan; wherein the traditional Chinese medicine extract is composed of Polygala tenuifolia extract, Ziziphus jujuba var. spinosa extract, and Albizia julibrissin bark extract.

[0009] Preferably, the mass ratio of the Polygala tenuifolia extract, Ziziphus jujuba var. spinosa extract and Albizia julibrissin bark extract is (2-4):(4-6):(2-4).

[0010] More preferably, the extraction method of the Polygala tenuifolia extract includes: mixing Polygala tenuifolia with a 60%-70% ethanol solution by volume, and extracting by ultrasonication to obtain the Polygala tenuifolia extract.

[0011] More preferably, the extraction method of the jujube seed extract includes: ultra-finely pulverizing jujube seeds, mixing them with water, and then enzymatically hydrolyzing them with a compound enzyme to obtain the jujube seed extract.

[0012] More preferably, the complex enzyme consists of elastase and aminopeptidase.

[0013] More preferably, the extraction method of the Albizia bark extract includes: mixing Albizia bark with a 70%-80% (v / v) ethanol solution, and extracting by heating and reflux to obtain the Albizia bark extract.

[0014] Preferably, the probiotics consist of Digestive-associated Lactobacillus CICC 6284 and Bifidobacterium adolescentis CICC 24573.

[0015] The present invention also provides a method for preparing the above-mentioned antidepressant and calming composition, comprising: mixing chitosan with an acetic acid solution to obtain a chitosan solution; mixing a traditional Chinese medicine extract, astaxanthin, theanine and chitosan solution to obtain a suspension; freeze-drying under vacuum to obtain a dry powder, and mixing with probiotics to obtain the antidepressant and calming composition.

[0016] The present invention also provides an application of the above-described antidepressant and calming composition in the preparation of sleep-improving products.

[0017] Preferably, the product includes capsules, tablets, granules, oral liquids, and powders.

[0018] Compared with the prior art, the present invention has the following beneficial effects:

[0019] This invention provides a calming and soothing composition for improving sleep quality, comprising: traditional Chinese medicine extracts, astaxanthin, theanine, probiotics, and chitosan; the traditional Chinese medicine extracts consist of extracts of Polygala tenuifolia, Ziziphus jujuba var. spinosa, and Albizia julibrissin. In preparation, chitosan is first mixed with an acetic acid solution to form a solution, then the traditional Chinese medicine extracts, astaxanthin, and theanine are added to form a suspension, which is then freeze-dried under vacuum and mixed with probiotics.

[0020] Among them, Polygala tenuifolia extract calms the mind and soothes the nerves, clears phlegm and opens the orifices; Ziziphus jujuba seed extract nourishes the liver and calms the mind, astringes sweat and promotes body fluid production; Albizia julibrissin bark extract relieves depression and calms the nerves, promotes blood circulation and reduces swelling. These three ingredients work synergistically to improve insomnia caused by multiple factors. Astaxanthin has antioxidant and nerve-protecting properties, regulates sleep rhythm, and reduces stress hormones; theanine soothes nerves, regulates neurotransmitters, and reduces nighttime awakenings; probiotics (Lactobacillus comorbidus CICC 6284 and Bifidobacterium adolescentis CICC 24573) regulate intestinal flora and promote the production of calming neurotransmitters; chitosan acts as a carrier to improve the stability and bioavailability of the ingredients. Overall, it can relieve depression and soothe the nerves, shorten the sleep latency period, prolong the deep sleep duration, improve sleep quality, and also has a mood-regulating effect.

[0021] Animal experiments have shown that the composition of this invention can shorten the sleep latency, prolong the total sleep time, and increase the content of 5-hydroxytryptamine and γ-aminobutyric acid in brain tissue. It can be used to prepare sleep improvement products, and has the effects of relieving depression, calming the nerves, and soothing the nerves. It is safe and widely applicable. Detailed Implementation

[0022] This invention provides a calming and soothing composition for improving sleep quality, comprising the following raw materials in parts by weight: 3-5 parts of traditional Chinese medicine extract, 3-5 parts of astaxanthin, 1-3 parts of theanine, 3-5 parts of probiotics, and 10-15 parts of chitosan; wherein the traditional Chinese medicine extract is composed of Polygala tenuifolia extract, Ziziphus jujuba var. spinosa extract, and Albizia julibrissin bark extract.

[0023] The preferred mass ratio of the Polygala tenuifolia extract, Ziziphus jujuba var. spinosa extract, and Albizia julibrissin bark extract in this invention is (2-4):(4-6):(2-4), and more preferably 3:5:3.

[0024] The preferred extraction method for the Polygala tenuifolia extract of the present invention includes: mixing Polygala tenuifolia with a 60%-70% (v / v) ethanol solution, and then extracting by ultrasonication to obtain the Polygala tenuifolia extract. More preferably, the method includes: pulverizing Polygala tenuifolia, passing it through a 200-400 mesh sieve, adding 10-15 times its weight (v / v) of a 60%-70% ethanol solution, and extracting by ultrasonication 1-3 times at 150-250W, 20-40kHz, and 40-50℃ for 20-60 minutes each time, followed by filtration, concentration, and drying to obtain the Polygala tenuifolia extract.

[0025] This invention contains Polygala tenuifolia extract, which calms the mind and soothes the nerves. It can address insomnia, palpitations, and forgetfulness caused by restlessness and disharmony between the heart and kidneys. It improves sleep by harmonizing the heart and kidneys and calming the mind. At the same time, it can resolve restlessness caused by phlegm obstructing the orifices. In synergy with Ziziphus jujuba seed extract and Albizia julibrissin bark extract, it enhances the effects of the composition in relieving depression, calming the mind, and improving sleep quality.

[0026] The preferred extraction method for the jujube seed extract of the present invention includes: ultra-fine pulverizing jujube seeds, mixing with water, and then enzymatically hydrolyzing with a compound enzyme to obtain the jujube seed extract. More preferably, the method includes: ultra-fine pulverizing jujube seeds, passing them through an 800-1000 mesh sieve to obtain ultrafine powder, adding 8-12 times their weight of water, enzymatically hydrolyzing with a compound enzyme, inactivating the enzyme, filtering, concentrating, and drying to obtain the jujube seed extract. The compound enzyme is preferably composed of elastase and aminopeptidase in a mass ratio of 1:(1-3), more preferably 1:2. The amount of the compound enzyme added is preferably 3%-6% of the mass of the ultrafine powder, more preferably 5%. The enzymatic hydrolysis temperature is preferably 38-42℃, more preferably 40℃, and the pH value is preferably 8-8.5, more preferably 8.2.

[0027] This invention enriches the active ingredients by ultra-fine pulverization and compound enzyme extraction of Polygala tenuifolia. Its core effects are to nourish the liver and calm the mind, astringe sweat and promote body fluid production. It is specifically designed to treat insomnia, palpitations and excessive dreaming caused by deficiency and restlessness. It stabilizes the mind by regulating neurotransmitter levels and prolongs the duration of deep sleep. Its liver-nourishing and blood-tonifying effects can improve shallow sleep and easy awakening caused by insufficient liver blood. When combined with other Chinese herbal extracts, it enhances the targeted sleep-regulating effect of the composition.

[0028] The preferred extraction method for the Albizia bark extract of the present invention includes: mixing Albizia bark with a 70%-80% (v / v) ethanol solution, and extracting by reflux to obtain the Albizia bark extract. More preferably, the method includes: pulverizing Albizia bark through a 300-400 mesh sieve, mixing it with 10-15 times its weight of a 70%-80% (v / v) ethanol solution, extracting by reflux at 80-83°C 1-3 times, each time for 40-80 minutes, filtering, combining the filtrates, concentrating, and drying to obtain the Albizia bark extract.

[0029] This invention utilizes ethanol reflux extraction of Albizia bark, resulting in a product rich in flavonoids and saponins. Its core functions are to relieve depression, calm the mind, promote blood circulation, and reduce swelling. It primarily alleviates insomnia and anxiety caused by emotional distress, improving sleep by relieving liver stagnation and calming emotions. Its blood-activating effect can also help harmonize Qi and blood, reducing sleep disorders caused by poor Qi and blood circulation. Combined with extracts of Polygala tenuifolia and Ziziphus jujuba var. spinosa, it comprehensively addresses sleep problems caused by various factors.

[0030] In this invention, the extracts of traditional Chinese medicine include Polygala tenuifolia extract, which can calm the mind and soothe the nerves, clear phlegm and open the orifices, and improve insomnia caused by restlessness; Ziziphus jujuba var. spinosa extract, which can nourish the liver and calm the mind, astringe sweat and promote body fluid production, and has a significant effect on insomnia due to deficiency and restlessness, palpitations and excessive dreaming; and Albizia julibrissin bark extract, which can relieve depression and soothe the nerves, promote blood circulation and reduce swelling, and relieve insomnia and anxiety caused by emotional depression. The combination of the three has a strong effect of relieving depression and soothing the nerves, and can significantly improve sleep quality.

[0031] The astaxanthin of this invention has a dual effect of neuroprotection and rhythm regulation. Its antioxidant activity can remove excess free radicals in central nerve cells, protect the structural integrity of neurons in brain regions related to sleep, and reduce sleep rhythm disorders caused by oxidative stress. At the same time, it can reduce the level of stress hormones such as cortisol, alleviate the interference of anxiety on sleep, enhance mitochondrial function, improve the energy metabolism efficiency of nerve cells, and improve the problems of shallow sleep and easy awakening.

[0032] This invention utilizes a traditional Chinese medicine extract to harmonize organ function, soothe the liver and relieve depression, and precisely promote the synthesis and release of serotonin, γ-aminobutyric acid (GABA), and other neurotransmitters that calm the mind, directly addressing the core pathogenesis of insomnia caused by emotional distress and disharmony between the heart and kidneys. Astaxanthin, with its powerful antioxidant activity, targets and protects neurons in sleep-related brain regions, reducing the interference of neuroinflammation on sleep pathways, thus laying a solid neurophysiological foundation for the regulatory effects of the traditional Chinese medicine extract. The polar components in the extract improve the water solubility and intestinal mucosal permeability of astaxanthin, enhancing its bioavailability. Furthermore, astaxanthin inhibits the oxidative degradation of the active ingredients in the traditional Chinese medicine, prolonging their duration of action in the body. These two components work synergistically to achieve the dual effects of rapidly relieving insomnia symptoms and fundamentally maintaining nerve and organ homeostasis, significantly enhancing the targeted, effective, and long-lasting effects of the composition in relieving depression and calming the mind.

[0033] The theanine described in this invention, as a unique active ingredient in tea, can soothe nerves and relieve anxiety. By regulating the levels of neurotransmitters such as dopamine and serotonin in the brain, it can reduce mental tension. At the same time, it can improve sleep structure, reduce the number of nighttime awakenings, prolong deep sleep time, and has no sedative side effects, thus improving sleep quality while ensuring daytime mental state.

[0034] The probiotics described in this invention are preferably composed of Lactobacillus digestiveis CICC 6284 and Bifidobacterium adolescentis CICC 24573. Among the probiotics, the number of Lactobacillus digestiveis CICC 6284 is preferably 100 million to 300 million / g, more preferably 200 million / g, and the number of Bifidobacterium adolescentis CICC 24573 is preferably 300 million to 600 million / g, more preferably 400 million / g.

[0035] This invention utilizes *Lactobacillus co-occurringus* CICC 6284, which regulates the intestinal flora structure, inhibits the proliferation of pathogenic bacteria, reduces neuroinflammation, and promotes the production of sedative neurotransmitter precursors. *Bifidobacterium adolescentis* CICC 24573 metabolizes short-chain fatty acids, regulating central nervous system excitability and alleviating anxiety. The combination of these two ingredients maintains intestinal microecological homeostasis, reducing the negative impact of intestinal stress on the central nervous system while enhancing the absorption and utilization efficiency of herbal extracts and theanine, forming a "gut-nerve-active ingredient" linkage mechanism. This addresses the root cause of mood-related sleep disorders and improves the overall calming and sedative effects of the composition.

[0036] The present invention also provides a method for preparing the above-mentioned antidepressant and calming composition, comprising: mixing chitosan with an acetic acid solution to obtain a chitosan solution; mixing a traditional Chinese medicine extract, astaxanthin, theanine and chitosan solution to obtain a suspension; freeze-drying under vacuum to obtain a dry powder, and mixing with probiotics to obtain the antidepressant and calming composition.

[0037] The present invention also provides an application of the above-described antidepressant and calming composition in the preparation of sleep-improving products.

[0038] Preferably, the product includes capsules, tablets, granules, oral liquids, and powders.

[0039] In this invention, unless otherwise specified, all raw material components are commercially available products well known to those skilled in the art.

[0040] The technical solutions of this invention will be clearly and completely described below with reference to the embodiments thereof. Obviously, the described embodiments are only a part of the embodiments of this invention, and not all of them. All other embodiments obtained by those skilled in the art based on the embodiments of this invention without creative effort are within the scope of protection of this invention.

[0041] Unless otherwise specified, the following embodiments are all conventional methods.

[0042] Unless otherwise specified, all materials and reagents used in the following examples are commercially available.

[0043] Elastase, with an enzyme activity of 200,000 U / g, was sourced from Shaanxi Langde Biotechnology Co., Ltd.; aminopeptidase, specifically alanine aminopeptidase, with an enzyme activity of 100,000 U / g, was sourced from Zhengzhou Weifeng Biotechnology Co., Ltd.; papain, with an enzyme activity of 200,000 U / g, was sourced from Nanning Pangbo Bioengineering Co., Ltd.; bromelain, with an enzyme activity of 100,000 U / g, was sourced from Nanning Pangbo Bioengineering Co., Ltd.; *Companilactobacillus alimentarius* CICC 6284, *Bifidobacterium adolescentis* CICC 24573, *Lactobacillus helveticus* CICC 22818, and *Bifidobacterium longum* CICC 6207 were all sourced from the China Industrial Microbiology Culture Collection Center.

[0044] Example 1: Antidepressant and Sedative Composition

[0045] (1) Preparation of extracts from traditional Chinese medicine

[0046] Extraction of Polygala tenuifolia extract: Polygala tenuifolia was crushed, passed through a 300-mesh sieve, and 12 times its weight of 65% ethanol solution was added. The mixture was ultrasonically extracted twice at 200W, 30kHz and 45℃ for 40 minutes each time. The mixture was filtered, the filtrates were combined, concentrated and dried to a water content of 3wt% to obtain Polygala tenuifolia extract.

[0047] Extraction of Ziziphus jujuba seed extract: Ziziphus jujuba seeds were ultra-finely pulverized to below 900 mesh to obtain ultra-fine powder. 10 times the weight of water was added, along with 5% of the weight of the ultra-fine powder's compound enzyme. Enzymatic hydrolysis was carried out at 40℃ and pH 8.5 for 3 hours to inactivate the enzyme. The mixture was filtered, the filtrate was concentrated, and dried to a water content of 2wt% to obtain the Ziziphus jujuba seed extract. The compound enzyme consisted of elastase and aminopeptidase in a mass ratio of 1:2.

[0048] Extraction of Albizia bark extract: Albizia bark was pulverized and passed through a 350-mesh sieve, mixed with 12 times its weight of a 75% ethanol solution, and extracted twice by reflux at 82°C for 60 min each time. The extract was filtered, the filtrates were combined, concentrated, and dried to a water content of 4 wt% to obtain Albizia bark extract.

[0049] The extracts of Polygala tenuifolia, Ziziphus jujuba var. spinosa, and Albizia julibrissin were mixed in a mass ratio of 3:5:3 to obtain the traditional Chinese medicine extract.

[0050] (2) Weighing

[0051] A probiotic was obtained by mixing Lactobacillus digestiveis CICC 6284 and Bifidobacterium adolescentis CICC 24573. The probiotic contained Lactobacillus digestiveis CICC 6284 with a count of 200 million / g and Bifidobacterium adolescentis CICC 24573 with a count of 400 million / g.

[0052] Weigh the following by weight: 4 parts of Chinese herbal extract, 4 parts of astaxanthin, 2 parts of theanine, 4 parts of probiotics, and 12 parts of chitosan.

[0053] (3) Preparation of the antidepressant and calming composition

[0054] Chitosan and a 2% (v / v) acetic acid solution were mixed at a mass ratio of 1:60 and stirred at 30°C and 400 rpm for 40 min to obtain a chitosan solution. Traditional Chinese medicine extracts, astaxanthin, and theanine were added sequentially to the chitosan solution, stirred at 25°C and 500 rpm for 30 min, and then ultrasonically dispersed at 200 W and 30 kHz for 30 min to obtain a suspension. This suspension was concentrated and freeze-dried under vacuum to a water content of 2 wt% to obtain a dry powder. Probiotics were mixed with the dry powder and mixed at 25 rpm for 20 min to obtain a calming and sedative composition.

[0055] Example 2: Antidepressant and calming composition

[0056] (1) Preparation of extracts from traditional Chinese medicine

[0057] Extraction of Polygala tenuifolia extract: Pulverize Polygala tenuifolia, pass it through a 200-mesh sieve, add 10 times its weight of 60% ethanol solution, and extract by ultrasonication at 150W, 20kHz and 40℃ for 60min. Filter, concentrate the filtrate and dry it to a water content of 2wt% to obtain Polygala tenuifolia extract.

[0058] Extraction of Ziziphus jujuba seed extract: Ziziphus jujuba seeds were ultra-finely pulverized to below 800 mesh to obtain ultrafine powder. Eight times the weight of water was added, along with 6% of the weight of the ultrafine powder's compound enzyme. The mixture was enzymatically hydrolyzed at 38℃ and pH 8 for 3.5 hours to inactivate the enzyme. The mixture was then filtered, the filtrate was concentrated, and dried to a moisture content of 3 wt% to obtain the Ziziphus jujuba seed extract. The compound enzyme consisted of elastase and aminopeptidase in a 1:1 mass ratio.

[0059] Extraction of Albizia bark extract: Albizia bark was crushed and passed through a 300-mesh sieve, mixed with 10 times its weight of a 70% ethanol solution, and extracted by reflux at 80°C for 80 min. The mixture was then filtered, concentrated, and dried to a water content of 3 wt% to obtain Albizia bark extract.

[0060] The extracts of Polygala tenuifolia, Ziziphus jujuba var. spinosa, and Albizia julibrissin were mixed in a mass ratio of 2:4:2 to obtain the traditional Chinese medicine extract.

[0061] (2) Weighing

[0062] A probiotic was obtained by mixing Lactobacillus digestiveis CICC 6284 and Bifidobacterium adolescentis CICC 24573. The probiotic contained Lactobacillus digestiveis CICC 6284 with a count of 100 million / g and Bifidobacterium adolescentis CICC 24573 with a count of 300 million / g.

[0063] Weigh the following ingredients by weight: 3 parts of Chinese herbal extract, 5 parts of astaxanthin, 1 part of theanine, 5 parts of probiotics, and 10 parts of chitosan.

[0064] (3) Preparation of the antidepressant and calming composition

[0065] Chitosan and a 1% acetic acid solution were mixed at a mass ratio of 1:50 and stirred at 28°C and 350 rpm for 45 min to obtain a chitosan solution. Traditional Chinese medicine extracts, astaxanthin, and theanine were added sequentially to the chitosan solution and stirred at 23°C and 450 rpm for 35 min. The mixture was then ultrasonically dispersed at 180 W and 25 kHz for 35 min to obtain a suspension. This suspension was concentrated and freeze-dried under vacuum to a water content of 3 wt% to obtain a dry powder. Probiotics were mixed with the dry powder and stirred at 20 rpm for 30 min to obtain a calming and sedative composition.

[0066] Example 3: Antidepressant and Sedative Composition

[0067] (1) Preparation of extracts from traditional Chinese medicine

[0068] Extraction of Polygala tenuifolia extract: Polygala tenuifolia was crushed, passed through a 400-mesh sieve, and 15 times its weight of 70% ethanol solution was added. The mixture was ultrasonically extracted three times at 250W, 40kHz and 50℃ for 20 minutes each time. The mixture was filtered, the filtrates were combined, concentrated and dried to a water content of 4wt% to obtain Polygala tenuifolia extract.

[0069] Extraction of Ziziphus jujuba seed extract: Ziziphus jujuba seeds were ultra-finely pulverized to below 1000 mesh to obtain ultrafine powder. 12 times their weight of water were added, along with 3% of the weight of the ultrafine powder's compound enzyme. Enzymatic hydrolysis was carried out at 42℃ and pH 8.5 for 2.5 hours to inactivate the enzyme. The mixture was filtered, the filtrate was concentrated, and dried to a moisture content of 3 wt% to obtain the Ziziphus jujuba seed extract. The compound enzyme consisted of elastase and aminopeptidase in a mass ratio of 1:3.

[0070] Extraction of Albizia bark extract: Albizia bark was pulverized and passed through a 400-mesh sieve, mixed with 15 times its weight of 80% ethanol solution, and extracted by reflux at 83°C three times for 40 minutes each time. The extract was filtered, the filtrates were combined, concentrated, and dried to a water content of 2 wt% to obtain Albizia bark extract.

[0071] The extracts of Polygala tenuifolia, Ziziphus jujuba var. spinosa, and Albizia julibrissin were mixed in a mass ratio of 4:6:4 to obtain the traditional Chinese medicine extract.

[0072] (2) Weighing

[0073] A probiotic was obtained by mixing Lactobacillus digestiveis CICC 6284 and Bifidobacterium adolescentis CICC 24573. The probiotic contained Lactobacillus digestiveis CICC 6284 with a count of 200 million / g and Bifidobacterium adolescentis CICC 24573 with a count of 400 million / g.

[0074] Weigh the following ingredients by weight: 5 parts of Chinese herbal extract, 3 parts of astaxanthin, 3 parts of theanine, 3 parts of probiotics, and 15 parts of chitosan.

[0075] (3) Preparation of the antidepressant and calming composition

[0076] Chitosan and a 3% acetic acid solution were mixed at a mass ratio of 1:70 and stirred at 32°C and 450 rpm for 35 min to obtain a chitosan solution. Traditional Chinese medicine extracts, astaxanthin, and theanine were added sequentially to the chitosan solution, stirred at 28°C and 550 rpm for 25 min, and then ultrasonically dispersed at 150 W and 25 kHz for 27 min to obtain a suspension. This suspension was concentrated and freeze-dried under vacuum to a water content of 4 wt% to obtain a dry powder. Probiotics were mixed with the dry powder and mixed at 28 rpm for 18 min to obtain a calming and sedative composition.

[0077] Comparative Example 1

[0078] Unlike Example 1, the preparation method of the Chinese herbal extract in step (1) is as follows: Polygala tenuifolia, Ziziphus jujuba var. spinosa and Albizia julibrissin bark are weighed in a weight ratio of 3:5:3, pulverized separately, passed through a 300-mesh sieve, mixed, and then 10 times the weight of water is added. The mixture is heated and refluxed at 102°C twice for 60 minutes each time. After filtration, the filtrates are combined, concentrated, and dried to a water content of 4 wt% to obtain the Chinese herbal extract.

[0079] Comparative Example 2

[0080] Unlike Example 1, in step (1), the ethanol solutions of Polygala tenuifolia extract and Albizia julibrissin bark extract were both replaced with purified water, and the temperature of the reflux extraction was adjusted to 102°C, while other conditions remained unchanged.

[0081] Comparative Example 3

[0082] Unlike Example 1, the extraction method of jujube seed extract in step (1) is as follows: Jujube seed is ultra-finely pulverized to below 900 mesh to obtain ultra-fine powder, 10 times its weight of water is added, and 5% of the weight of the ultra-fine powder of compound enzyme is added. The mixture is enzymatically hydrolyzed at 55℃ and pH 6.5 for 3 hours to inactivate the enzyme, filtered, the filtrate is concentrated and dried to a water content of 2wt% to obtain jujube seed extract; the compound enzyme is composed of papain and bromelain in a mass ratio of 1:2.

[0083] Comparative Example 4

[0084] Unlike Example 1, the herbal extract in step (2) is omitted, the weight of astaxanthin is adjusted to 8 parts, the total weight is the same as in Example 1, and step (1) is omitted.

[0085] Comparative Example 5

[0086] Unlike Example 1, astaxanthin in step (2) is omitted, and the weight of the drug extract is adjusted to 8 parts, with the total weight being the same as in Example 1.

[0087] Comparative Example 6

[0088] Unlike Example 1, in step (2), the digestive symbiotic lactobacillus CICC 6284 was replaced with Lactobacillus helveticus CICC 22818, and Bifidobacterium adolescentis CICC 24573 was replaced with Bifidobacterium longum CICC 6207, while other conditions remained unchanged.

[0089] Experimental example: Animal experiments

[0090] (1) Laboratory animals

[0091] SPF-grade 5-week-old ICR mice, weighing 20-22g, half male and half female. Housing environment: temperature 22±2℃, humidity 55±5%, 12h light / 12h dark cycle (light time 07:00-19:00), free access to water and food, and experiments began after 3 days of acclimatization.

[0092] (2) Grouping

[0093] Mice were divided into 12 groups of 20 each, with half males and half females: blank control group, model group, positive control group, Example 1 group, Example 2 group, Example 3 group, comparative example 1 group, comparative example 2 group, comparative example 3 group, comparative example 4 group, comparative example 5 group and comparative example 6 group.

[0094] The sample groups are Example 1, Example 2, Example 3, Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4, Comparative Example 5, and Comparative Example 6.

[0095] (3) Modeling

[0096] Except for the blank control group, mice in other groups were subjected to a combined model of chronic unpredictable mild stress (CUMS) and sleep deprivation to induce sleep disorders and anxiety.

[0097] Chronic unpredictable mild stress (concurrent with drug administration): day-night reversal (24h light / 24h darkness alternation), fasting for 24h, water restriction for 12h, tilted cage (45°, 24h), and damp bedding (24h). One type of stress was administered in the above order each day for 14 consecutive days.

[0098] Sleep deprivation (concurrent with drug administration): On days 12-14, mice were deprived of sleep for 6 hours (00:00-06:00) daily using the small platform water environment method (mice stand on a small platform above the water surface to avoid drowning. When the mice enter a sleep state, muscle relaxation causes them to fall from the platform into the water, thus waking them up, thereby interrupting the sleep cycle and achieving sleep deprivation for a specific duration) to establish a sleep disorder model.

[0099] (4) Dosage and method of administration

[0100] Positive control group: based on mouse body weight The dosage is as follows: Zolpidem tablets are crushed and mixed with physiological saline, and administered by gavage at a volume of 0.2 mL / 10 g body weight.

[0101] Sample group: based on mouse body weight The dosage is as follows: the composition is mixed with physiological saline to form a suspension, which is then administered by gavage at a volume of 0.2 mL / 10 g body weight.

[0102] The model group and the blank control group were given an equal volume of physiological saline by gavage.

[0103] Dosing cycle: Each group was administered the medication by gavage for 14 consecutive days at a fixed time (18:00) every day.

[0104] (5) Detection method

[0105] 1) Sleep indicators

[0106] One hour after the last oral administration to each group, the mice in each group were injected intraperitoneally with sodium pentobarbital (40 mg / kg).

[0107] Sleep latency: Record the time from injection to falling asleep (disappearance of righting reflex).

[0108] Total sleep time: Record the total time from the disappearance to the recovery of the righting reflex after injection of sodium pentobarbital.

[0109] The disappearance of the righting reflex refers to the fact that if a mouse cannot return to a prone position on its own within 10 seconds when gently placed on its side or back, it is considered to have fallen asleep.

[0110] The results of the sleep latency and total sleep time of mice in each group are shown in Table 1.

[0111] Table 1. Sleep latency and total sleep time in each group of mice

[0112] Grouping Sleep latency (min) Total sleep time (min) Blank control group 6.54 22.92 Model group 17.71 7.25 Positive control group 7.83 18.50 Example 1 Group 8.62 16.71 Example 2 group 8.73 16.38 Example 3 Group 8.76 15.90 Comparative Example 1 11.36 12.27 Comparative Example 2 10.83 12.84 Comparative Example 3 Groups 10.30 13.67 Comparative Example 4 Groups 13.12 11.59 Comparative Example 5 Groups 12.67 11.83 Comparative Example 6 Groups 10.55 13.36

[0113] Table 1 systematically evaluates the efficacy of different intervention programs in improving sleep disorders induced by combined stress in mice, focusing on two core indicators: sleep latency (reflecting the ease of falling asleep) and total sleep time (reflecting sleep maintenance ability). The blank control group, serving as a reference for normal physiological conditions, showed stable spontaneous sleep rhythms, smooth sleep onset, and sufficient sleep duration. In contrast, the model group, after treatment with a combination of chronic unpredictable mild stress (CUMS) and sleep deprivation, exhibited a significantly prolonged sleep latency and a sharp decrease in total sleep time, indicating typical sleep onset difficulty and sleep maintenance impairment, confirming successful model establishment. The positive control group effectively shortened sleep onset time and prolonged sleep duration, verifying the model's sensitivity to positive drugs and providing a reliable reference for subsequent evaluation of the effects on sample groups.

[0114] Compared with the model group, the sleep latency in Examples 1-3 was significantly shortened and the total sleep time was prolonged. Although the sleep latency was slightly longer and the total sleep time was slightly shorter than that in the positive control group, it still showed a sleep improvement effect close to that of the drug. Comparative Examples 1-3, due to insufficient optimization of the Chinese herbal extraction process (mixed extraction, solvent replacement, enzyme system changes), had a prolonged sleep latency and a reduced total sleep time. This confirms that optimized processes such as ultrasonic alcohol extraction of Polygala tenuifolia and complex enzymatic hydrolysis of Ziziphus jujuba var. spinosa elastase-aminopeptidase are the core links in enhancing the activity of the Chinese herbal extract and improving sleep. Comparative Examples 4 and 5 had longer sleep latency and insufficient total sleep time, with significantly weaker effects compared to the Example group. This indicates that the Chinese herbal extract and astaxanthin do not simply have a synergistic effect, but rather work together through a synergistic mechanism of organ regulation and neuroprotection to shorten sleep latency and prolong sleep duration; both are indispensable. The effect of Comparative Example 6 was weaker than that of Example 6, indicating that the specific combination of Lactobacillus symbioticis CICC6284 and Bifidobacterium adolescentis CICC24573 has a stronger effect on regulating the gut-brain axis and helping to improve sleep.

[0115] 2) Biochemical indicators

[0116] After the sleep index test was completed, the mice were euthanized by cervical dislocation, the head of the mice was dissected, the brain tissue was taken, the meninges and blood vessels were removed, and the brain tissue was quickly rinsed in pre-cooled sterile saline for 10 seconds. The rinsed brain tissue was mixed with saline at a mass ratio of 1:9, homogenized at 4°C, and centrifuged at 3000 r / min at 4°C for 15 minutes to obtain the supernatant.

[0117] The levels of 5-hydroxytryptamine (5-HT) and γ-aminobutyric acid (GABA) in brain tissue were measured according to the kit instructions. The specific results are shown in Table 2.

[0118] Table 2. Content of 5-HT and GABA in brain tissue of mice in each group

[0119] Grouping 5-HT (ng / g) GABA (nmol / g) Blank control group 10.24 12.77 Model group 3.82 6.05 Positive control group 8.76 10.59 Example 1 Group 7.81 9.81 Example 2 group 7.66 9.74 Example 3 Group 7.54 9.50 Comparative Example 1 6.09 8.37 Comparative Example 2 6.27 8.42 Comparative Example 3 Groups 6.50 8.82 Comparative Example 4 Groups 5.43 7.96 Comparative Example 5 Groups 5.78 8.18 Comparative Example 6 Groups 6.45 8.63

[0120] Table 2 reveals the neurobiochemical mechanisms by detecting the levels of 5-HT and GABA in brain tissue, demonstrating the mechanisms by which different interventions improve sleep. Changes in their levels are directly correlated with sleep function. 5-HT is a key neurotransmitter regulating the sleep-wake cycle; decreased 5-HT levels lead to difficulty initiating sleep. GABA, a major inhibitory neurotransmitter in the central nervous system, can cause increased nerve excitability and sleep maintenance disorders when its levels are insufficient. The blank control group serves as a normal reference, indicating that the mouse's central neurotransmitter system is in balance, providing a biochemical basis for normal sleep. After combined stress treatment, the model group showed a sharp drop in 5-HT and a decrease in GABA levels, indicating that combined stress induces sleep disorders and validating the effectiveness of the model. Data from the positive control group show that it can improve sleep function by increasing the levels of central sedative neurotransmitters. The reliability of the detection indicators provides a reference standard for the mechanism analysis of the sample groups.

[0121] Compared with the model group, the 5-HT and GABA contents of the Example 1-3 groups were increased. Although they did not completely recover to the level of the blank group, they significantly reversed the decreasing trend of neurotransmitters. The 5-HT and GABA contents of Comparative Examples 1-3 were reduced due to defects in the traditional Chinese medicine extraction process (mixed extraction, solvent replacement, and enzyme system changes). This indicates that the optimized traditional Chinese medicine extraction process can more efficiently enrich active ingredients such as polygala saponins and jujube seed saponins, thereby enhancing the regulatory ability on the 5-HT synthesis pathway (such as tryptophan hydroxylase activation) and GABA release. Process defects directly lead to a weakening of the neurotransmitter regulation effect. Comparative Examples 4 and 5 showed significantly weaker effects than the Example Group, revealing a synergistic regulatory effect between the herbal extract and astaxanthin on neurotransmitters. The herbal extract promotes neurotransmitter synthesis by regulating organ function (e.g., soothing the liver and relieving depression, nourishing the liver and calming the mind), while astaxanthin protects the activity of neurotransmitter synthesis-related enzymes (e.g., tryptophan hydroxylase, glutamate decarboxylase) through antioxidant activity. Together, they maintain the balance of central neurotransmitters, and the absence of either component leads to a significant decrease in the regulatory effect. Comparative Example 6 showed lower results than the Example Group, indicating that the specific combination of *Lactobacillus symbioticis* CICC6284 and *Bifidobacterium adolescentis* CICC24573 can regulate central neurotransmitter metabolism by producing short-chain fatty acids (e.g., butyric acid), and its gut-brain axis regulation is more targeted. Replacing it with other strains weakens the auxiliary regulatory effect on neurotransmitters.

[0122] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle 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 for improving sleep quality, characterized in that, It is made from the following raw materials in parts by weight: 3-5 parts of Chinese herbal extract, 3-5 parts of astaxanthin, 1-3 parts of theanine, 3-5 parts of probiotics, and 10-15 parts of chitosan. The herbal extract is composed of Polygala tenuifolia extract, Ziziphus jujuba seed extract and Albizia julibrissin bark extract; The extraction method of Polygala tenuifolia extract includes: mixing Polygala tenuifolia with a 60%-70% ethanol solution by volume, and then extracting by ultrasonication to obtain Polygala tenuifolia extract; The extraction method of jujube seed extract includes: ultra-finely pulverizing jujube seeds, mixing them with water, and then hydrolyzing them with a compound enzyme to obtain jujube seed extract; The complex enzyme consists of elastase and aminopeptidase; The extraction method of Albizia bark extract includes: mixing Albizia bark with a 70%-80% (v / v) ethanol solution, and extracting by heating and reflux to obtain Albizia bark extract; The probiotics consist of Lactobacillus digestive symbioticus CICC 6284 and Bifidobacterium adolescentis CICC 24573; The mass ratio of Polygala tenuifolia extract, Ziziphus jujuba var. spinosa extract and Albizia julibrissin bark extract was (2-4):(4-6):(2-4).

2. A method for preparing the composition according to claim 1, characterized in that, include: Chitosan was mixed with an acetic acid solution to obtain a chitosan solution; a traditional Chinese medicine extract, astaxanthin, and theanine were mixed with the chitosan solution to obtain a suspension; the suspension was then freeze-dried under vacuum to obtain a dry powder, which was then mixed with probiotics to obtain a composition.

3. The use of the composition according to claim 1 in the preparation of a sleep-improving product.

4. The application according to claim 3, characterized in that, The products include capsules, tablets, granules, oral liquids, or powders.