A ganoderma lucidum composition for promoting sleep and anti-depression nervonic acid and application thereof

Abstract

The application discloses a kind of for promoting sleep and anti-depression ganoderma lucidum composition and its application, it is related to biological medicine and health-care food technical field, the composition with neuroacid, ganoderma extract as core, with jujube seed extract, gamma-aminobutyric acid, phosphatidylserine and plant lactobacillus P-8 probiotics, by melt emulsification-high pressure homogenization method preparation into solid lipid nanoparticle targeted preparation, the application can effectively repair damaged nerve structure, regulate central nervous system neurotransmitter balance, reshape HPA axis homeostasis, control brain-gut axis balance, break insomnia and depression vicious cycle, and the formula of composition is natural safety, no drug dependence, preparation process is simple controllable, easy to industrialization, can be widely used in sleep-promoting, anti-depression drug and health-care food field, market prospect is wide.

Description

Technical Field

[0001] This invention relates to the fields of biomedicine and health food technology, and in particular to a combination of nervonic acid and Ganoderma lucidum for promoting sleep and anti-depression, and its application, especially suitable for the intervention and treatment of comorbid sleep disorders and depression in the general population. Background Technology

[0002] Sleep disorders and depression are prevalent comorbid public health problems in modern society, exhibiting a typical vicious cycle: chronic insomnia significantly increases the risk of depression, while depression further exacerbates sleep disturbances, leading to long-term, recurrent episodes that severely damage physical and mental health and quality of life. Currently, mainstream clinical interventions primarily rely on chemical sedatives and antidepressants. While these can control symptoms in the short term, long-term use can easily lead to drug dependence, daytime sleepiness, cognitive impairment, and other side effects, making them unsuitable for long-term management. Natural active ingredients, due to their high safety and fewer side effects, have become a research hotspot for sleep-depression comorbidity intervention.

[0003] Existing technologies related to natural products still have many key technical defects. For example, nervonic acid, as the core nerve repair component, is a long-chain unsaturated fatty acid with strong lipid solubility and poor water solubility. Ordinary oral preparations have low intestinal absorption efficiency, making it difficult for the active ingredient to reach the effective concentration and limiting the intervention effect. Moreover, the human blood-brain barrier has a strict screening function. The active ingredients in existing ordinary preparations mostly rely on passive diffusion transport, which has low permeability and makes it difficult to effectively enter the brain parenchyma. This makes it impossible to fully exert the functions of nerve repair and neurotransmitter regulation, resulting in poor intervention effect on sleep-depression comorbidity. People with chronic insomnia and depression commonly suffer from gut microbiota dysbiosis, with a decrease in the abundance of beneficial bacteria and an increase in the level of chronic inflammatory factors in the body. However, existing compositions only focus on the single dimension of central nervous system regulation and lack targeted intervention on gut microbiota. They cannot activate the bidirectional regulatory mechanism of the brain-gut axis and cannot break the comorbid pathological loop at its root.

[0004] In addition, most existing related products are simple compound formulations that only achieve physical mixing of ingredients without building a multi-target synergistic regulatory system. They also lack dedicated delivery technology, resulting in poor ingredient stability and slow onset of action. Furthermore, some products contain hormones such as melatonin, which pose a risk of dependence with long-term use and have poor compatibility. For example, the Chinese patent discloses a fat emulsion compound preparation containing nervonic acid and Ganoderma lucidum spore oil (publication number CN118766845A). This patent mainly targets brain health and intelligence improvement, but does not focus on intervention for the comorbidity of sleep and depression. For example, a Chinese patent discloses a neurotrophic acid composition for relieving sleep disorders and its application (publication number CN120938107A). The sleep composition disclosed in this patent contains melatonin, which poses a risk of side effects with long-term use.

[0005] To address the above problems, the present invention provides a nervonic acid Ganoderma lucidum composition for promoting sleep and antidepressant effects, and its application. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this invention provides a nervonic acid-based Ganoderma lucidum composition for promoting sleep and combating depression, and its application, thus solving the problems mentioned in the background art.

[0007] To achieve the above objectives, the present invention is implemented through the following technical solution: a nervonic acid-Ganoderma lucidum composition for promoting sleep and anti-depression, the composition comprising active ingredients and excipients, wherein, by weight, the active ingredients comprise: nervonic acid 10-20 parts, Ganoderma lucidum extract 20-50 parts, Ziziphus jujuba seed extract 10-30 parts, γ-aminobutyric acid 3-10 parts, phosphatidylserine 2.5-5 parts, and Lactobacillus plantarum P-8 postbiotic 5-15 parts; The active ingredient is prepared into solid lipid nanoparticles with a particle size of 80–120 nm and an encapsulation efficiency of ≥92%.

[0008] As a further technical solution of the present invention, the weight ratio of nervonic acid to Ganoderma lucidum extract is 1:2 to 1:4.

[0009] As a further technical solution of the present invention, the purity of the nervonic acid is ≥98%, the content of cis-15-tetracosenoic acid is ≥90%, the content of Ganoderma lucidum triterpenes in the Ganoderma lucidum extract is ≥25%, the content of Ganoderma lucidum polysaccharides is ≥15%, and the content of jujube seed saponin A in the jujube seed extract is ≥2%.

[0010] As a further technical solution of the present invention, the Lactobacillus plantarum P-8 postbiotic is a freeze-dried product of the fermentation supernatant of Lactobacillus plantarum P-8, and contains short-chain fatty acids and extracellular polysaccharide active ingredients.

[0011] As a further technical solution of the present invention, a lipid carrier is also included, wherein the lipid carrier comprises 25-35 parts by weight of glyceryl monostearate and 8-12 parts by weight of lecithin, and the preparation method of the solid lipid nanoparticles adopts the melt emulsification-high pressure homogenization method, specifically including the following: Step 1: Mix glyceryl monostearate and lecithin at a mass ratio of 3:1, and melt them in a constant temperature water bath at 73-77℃ for 10-15 minutes until the system is completely clear and free of particles. Then add the fat-soluble active ingredients nervonic acid, ganoderic triterpenes, and phosphatidylserine, and stir under magnetic stirring at 250-350 r / min for 8-10 minutes to obtain a homogeneous and stable oil phase. Protect the oil from light and provide antioxidant protection throughout the process. Step 2: Dissolve Ganoderma lucidum polysaccharide, jujube seed saponin, γ-aminobutyric acid, and Lactobacillus plantarum P-8 postbiotic in sterile purified water at 73-77℃. First, stir at a low speed of 180-220 r / min for 4-6 min to initially disperse the components, and then stir at a constant temperature of 250-350 r / min for 8-12 min until all components are completely dissolved, resulting in a clear sterile aqueous phase system. Step 3: Then, under constant temperature of 73-77℃ and high-speed shearing of 9000-11000r / min, the oil phase is added dropwise to the water phase at a uniform rate for 3-5 minutes, and shearing emulsification is continued for 4-6 minutes to prepare a uniform and stable O / W type primary emulsion with no layering and no floating oil. Step 4: Keep the system at a constant temperature of 70-75℃, first pre-homogenize at a pressure of 250-350 bar 1-3 times, then continuously homogenize at a rated working pressure of 550-650 bar 4-6 times, with each homogenization cycle lasting 1.5-2.5 min, to prepare a nano-suspension, and control the PDI of the suspension to be ≤0.25. Step 5: After homogenization, the suspension is gradually cooled and solidified. First, it is kept at 55-65℃ for 4-6 minutes, then cooled at a uniform rate to 20-25℃, and finally allowed to stand at 3-5℃ for 25-35 minutes to promote stable crystallization of the lipid skeleton. After solidification, it is filtered under pressure through a 0.22μm sterile organic microporous filter membrane to remove large particles and free impurities. Step 6: Add 8% to 10% freeze-drying protectant to the filtered high-purity suspension, and vacuum seal after freeze-drying to obtain a loose, porous solid lipid nanoparticle powder with excellent resolubility. Step 7: The prepared solid lipid nanoparticles have a particle size of 80-120 nm, a zeta potential of -25 to -35 mV, an encapsulation rate of active ingredients ≥92%, and a moisture content ≤3.0%.

[0012] As a further technical solution of the present invention, in step six, the freeze-drying protectant is a mixture of mannitol and sucrose in a mass ratio of 2:1.

[0013] As a further technical solution of the present invention, in the freeze-drying process of step six, the pre-freezing temperature is set to -48 to -42°C, the pre-freezing time is 3 to 5 hours, the vacuum degree is maintained at 10 to 15 Pa, the primary drying temperature is -32 to -28°C, the drying time is 10 to 14 hours, and the secondary drying temperature is 8 to 12°C, the drying time is 5 to 7 hours.

[0014] As a further technical solution of the present invention, the excipients are pharmaceutically or food-grade acceptable excipients, with a total weight of 20 to 60 parts, accounting for 15% to 35% of the total mass of the composition. The excipients include one or more of the following: 15 to 40 parts of microcrystalline cellulose, 0 to 15 parts of maltodextrin, and 0.5 to 5 parts of magnesium stearate.

[0015] As a further technical solution of the present invention, the dosage form of the composition is tablets, capsules, granules, or oral liquid.

[0016] The application of a combination of nervonic acid and Ganoderma lucidum for promoting sleep and antidepressant effects in the preparation of drugs or health foods for promoting sleep, antidepressant effects, and improving comorbid insomnia and depression.

[0017] This invention provides a nervonic acid-based Ganoderma lucidum composition for promoting sleep and combating depression, and its application, which has the following beneficial effects compared with the prior art: 1. This design is a combination of nervonic acid and Ganoderma lucidum for promoting sleep and combating depression. Unlike traditional single-ingredient products that only treat a single symptom, this product combines multiple natural active ingredients, all of which are natural raw materials that are both food and medicine. It does not contain chemical sedatives, antidepressants, melatonin, or other ingredients that are prone to causing dependence. On the one hand, it can repair damaged nerves, stabilize emotions, and alleviate low mood and depression. On the other hand, it can quickly soothe nerves, help you fall asleep, and prolong deep sleep. At the same time, it regulates the body's stress balance and intestinal microecology. Through the brain-gut linkage, it bidirectionally regulates the physical and mental state, completely breaking the vicious cycle of poor sleep, bad mood, and even more insomnia.

[0018] 2. This design presents a nervonic acid-Ganoderma lucidum composition for promoting sleep and combating depression. It employs solid lipid nanoparticle co-encapsulation technology to simultaneously encapsulate both lipid-soluble and water-soluble active ingredients, thus solving the problems of nervonic acid's strong lipid solubility, poor water solubility, and poor oral absorption. The nanoparticles mimic the structure of natural human chylomicrons, which can significantly improve intestinal absorption efficiency and can efficiently penetrate the blood-brain barrier to reach the target site in the brain. This solves the problems of slow onset of action, weak effects, and low utilization rate of traditional products.

[0019] 3. This design is a combination of nervonic acid and Ganoderma lucidum for promoting sleep and combating depression. It uses all natural ingredients that are both food and medicine, and does not contain melatonin, chemical sedatives, antidepressants or other ingredients that are prone to dependence. It is specially formulated to address common problems in modern people such as high stress, poor sleep, low mood, anxiety and irritability. It can improve sleep problems such as difficulty falling asleep, light sleep and easy awakening, and can also effectively relieve mild to moderate depression. It is suitable for daily conditioning for most adults and has a wide range of applications. Detailed Implementation

[0020] The technical solutions of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0021] Numerous authoritative basic research and pharmacological experiments have confirmed the independent pharmacological effects of nervonic acid and Ganoderma lucidum extract in sleep regulation and antidepressant treatment. Specific published studies are as follows: 1. Research on Nervonic Acid as a Single Agent: A team from the Qingdao Institute of Energy, Chinese Academy of Sciences, has confirmed that nervonic acid can significantly upregulate the expression of brain-derived neurotrophic factor (BDNF) and myelin basic protein (MBP), repair stress-damaged myelin sheaths, and improve core depressive behaviors in rats such as anhedonia and decreased activity levels. Meanwhile, multiple pharmacological studies have shown that nervonic acid can upregulate the expression of key sleep genes such as mtnr1aa and gabra1, reduce the number of nighttime awakenings, shorten sleep latency, and has a clear sedative-hypnotic effect. Furthermore, it can improve depressive states by regulating gut microbiota, reducing glutamate neurotoxicity in the brain, and inhibiting central inflammation.

[0022] 2. Single-ingredient research on Ganoderma lucidum extract: Multiple studies by Zhejiang University of Technology, China Modern Applied Pharmacy and other institutions have confirmed that Ganoderma lucidum triterpenes and polysaccharides are the core active ingredients for calming the mind. They can target and regulate the GABA and 5-HT neurotransmitter pathways related to sleep and mood, prolong the sleep time induced by sodium pentobarbital, and improve sleep rhythm disorders. Network pharmacology and animal model experiments have confirmed that the active ingredients of Ganoderma lucidum can antagonize depressive-like behaviors caused by chronic stress, downregulate the level of inflammatory factors in the body, regulate HPA axis homeostasis, and achieve sedative and calming effects and relieve depressive mood when used alone.

[0023] Example 1 A nervonic acid-Ganoderma lucidum composition for promoting sleep and anti-depression, comprising the following raw materials by weight: 15 parts nervonic acid, 35 parts Ganoderma lucidum extract, 20 parts Ziziphus jujuba seed extract, 6 parts γ-aminobutyric acid, 3.75 parts phosphatidylserine, 10 parts Lactobacillus plantarum P-8 postbiotic, and 30 parts glyceryl monostearate and 10 parts lecithin in the lipid carrier.

[0024] Among them, the purity of nervonic acid was 98.5%, and the content of cis-15-tetracosenoic acid was 91.2%; The triterpenes in Ganoderma lucidum extract account for 26.3%, and the polysaccharides account for 16.7%. The content of jujube seed saponin A in the jujube seed extract is 2.2%.

[0025] A combination of Ganoderma lucidum nervonic acid for promoting sleep and combating depression is prepared as follows: Step 1: Take 30 parts of food-grade and pharmaceutical-grade glyceryl monostearate and 10 parts of lecithin (mass ratio 3:1), mix them evenly, and then place them in a 75℃ constant temperature water bath to melt for 12 minutes. When the system is completely clear and free of solid particles, add nervonic acid, Ganoderma lucidum fat-soluble triterpenoid components and phosphatidylserine. Stir with magnetic stirring at 300 r / min for 9 minutes to obtain a homogeneous and stable oil phase. Protect from light throughout the process to prevent oxidation of unsaturated components. Step 2: Take 200 portions of sterile purified water and preheat it to 75°C. Add Ganoderma lucidum polysaccharide, jujube seed saponin, γ-aminobutyric acid, and Lactobacillus plantarum P-8 postbiotic. First, disperse the components by stirring at a low speed of 200 r / min for 5 min, and then stir at a constant temperature of 300 r / min for 10 min. After all components are completely dissolved, a clear, precipitate-free sterile aqueous phase is obtained. Step 3: Keep the system temperature constant at 75℃, set the high-speed shearing speed to 10000r / min, add the oil phase to the water phase at a uniform rate for 4 minutes, and continue shearing and emulsifying for 5 minutes to obtain a fine and uniform O / W type primary emulsion with no layering, no floating oil, and no large agglomerates. Step 4: Maintain the system at a constant temperature of 72℃. First, pre-homogenize twice with a pressure of 300 bar, then continuously homogenize five times with a working pressure of 600 bar. The duration of each homogenization cycle is 2 minutes. After homogenization, a uniform nano-suspension is obtained. Control the overall PDI ≤ 0.25. Step 5: Keep the nano suspension at 60℃ for 5 minutes, cool it down to 25℃ at a uniform rate, and then let it stand at 4℃ for 30 minutes to solidify it, so that the lipid skeleton can be fully stabilized and crystallized and particle aggregation is inhibited. After solidification, filter it under pressure through a 0.22μm sterile organic microporous filter membrane to remove large particle impurities and unencapsulated free components, and obtain a high-purity suspension. Step 6: Add 9% freeze-drying protectant (mannitol: sucrose = 2:1) to the high-purity suspension, stir evenly, pre-freeze at -45℃ for 4 hours, maintain vacuum at 12Pa, first dry at -30℃ for 12 hours, second dry at 10℃ for 6 hours, freeze-drying is completed and vacuum stopper is sealed to obtain loose, porous solid lipid nanoparticle powder with excellent resolubility; Step 7: Mix the obtained nanoparticle powder with 20 parts microcrystalline cellulose and 2 parts magnesium stearate evenly, pass through an 80-mesh sieve, and fill into No. 0 capsules to obtain capsules containing 0.45g of active ingredient per capsule.

[0026] Example 2 The preparation method used in this embodiment is the same as that in Example 1. The difference is that the raw materials weighed in this embodiment are: 10 parts of nervonic acid, 25 parts of Ganoderma lucidum extract, 15 parts of Ziziphus jujuba seed extract, 5 parts of γ-aminobutyric acid, 2.5 parts of phosphatidylserine, and 8 parts of Lactobacillus plantarum P-8 postbiotic.

[0027] The lipid carrier contains 25 parts of glyceryl monostearate and 8 parts of lecithin.

[0028] The purity of nervonic acid was 98.2%, and the content of cis-15-tetracosenoic acid was 90.5%. The Ganoderma lucidum extract contains 25.8% triterpenes and 15.6% polysaccharides. The content of jujube seed saponin A in the jujube seed extract is 2.1%.

[0029] Example 3 The preparation method used in this embodiment is the same as that in Example 1. The difference is that the raw materials weighed in this embodiment are: 20 parts of nervonic acid, 45 parts of Ganoderma lucidum extract, 25 parts of Ziziphus jujuba seed extract, 8 parts of γ-aminobutyric acid, 5 parts of phosphatidylserine, and 12 parts of Lactobacillus plantarum P-8 postbiotic.

[0030] The lipid carrier contains 35 parts of glyceryl monostearate and 12 parts of lecithin.

[0031] The purity of nervonic acid was 98.7%, and the content of cis-15-tetracosenoic acid was 92.1%. The triterpenes in Ganoderma lucidum extract account for 27.1%, and the polysaccharides account for 17.2%. The content of jujube seed saponin A in the jujube seed extract is 2.3%.

[0032] In summary, the dosage and ratio used in Example 1 are optimal. Moreover, the composition prepared by this invention has superior efficacy, production cost, and process stability compared to the shortcomings of traditional single-component formulations that only treat a single symptom. By combining multiple natural active ingredients, this invention can repair damaged nerves, stabilize emotions, and alleviate low mood and depression. It can also quickly soothe nerves, help with falling asleep, and prolong deep sleep. At the same time, it regulates the body's stress balance and gut microbiota. Through the brain-gut linkage, it bidirectionally regulates the body and mind, completely breaking the vicious cycle of poor sleep, bad mood, and even more insomnia.

[0033] The above description is merely a preferred embodiment of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention. Structures, devices, and operating methods not specifically described or explained in this invention are implemented according to conventional methods in the art unless otherwise specified or limited.

Claims

1. A combination of Ganoderma lucidum nervonic acid for promoting sleep and combating depression, characterized in that, The composition includes active ingredients and excipients. By weight, the active ingredients include: 10-20 parts of nervonic acid, 20-50 parts of Ganoderma lucidum extract, 10-30 parts of Ziziphus jujuba seed extract, 3-10 parts of γ-aminobutyric acid, 2.5-5 parts of phosphatidylserine, and 5-15 parts of Lactobacillus plantarum P-8 postbiotic. The active ingredient is prepared into solid lipid nanoparticles with a particle size of 80–120 nm and an encapsulation efficiency of ≥92%.

2. The sleep-promoting and antidepressant nervonic acid Ganoderma lucidum composition according to claim 1, characterized in that, The weight ratio of nervonic acid to Ganoderma lucidum extract is 1:2 to 1:

4.

3. The Ganoderma lucidum nervonic acid composition for promoting sleep and combating depression according to claim 1, characterized in that, The purity of the nervonic acid is ≥98%, and the content of cis-15-tetracosenoic acid is ≥90%. The Ganoderma lucidum extract contains ≥25% Ganoderma lucidum triterpenes and ≥15% Ganoderma lucidum polysaccharides. The content of jujube seed saponin A in the jujube seed extract is ≥2%.

4. The Ganoderma lucidum nervonic acid composition for promoting sleep and combating depression according to claim 1, characterized in that, The postbiotic of Lactobacillus plantarum P-8 is a freeze-dried supernatant from the fermentation of Lactobacillus plantarum P-8, and contains short-chain fatty acids and extracellular polysaccharide active ingredients.

5. The sleep-promoting and antidepressant nervonic acid Ganoderma lucidum composition according to claim 1, characterized in that, It also includes a lipid carrier, wherein the lipid carrier comprises 25-35 parts by weight of glyceryl monostearate and 8-12 parts by weight of lecithin. The preparation method of the solid lipid nanoparticles adopts a melt emulsification-high pressure homogenization method, specifically including the following: Step 1: Mix glyceryl monostearate and lecithin at a mass ratio of 3:1, and melt them in a constant temperature water bath at 73-77℃ for 10-15 minutes until the system is completely clear and free of particles. Then add the fat-soluble active ingredients nervonic acid, ganoderic triterpenes, and phosphatidylserine, and stir under magnetic stirring at 250-350 r / min for 8-10 minutes to obtain a homogeneous and stable oil phase. Protect the oil from light and provide antioxidant protection throughout the process. Step 2: Dissolve Ganoderma lucidum polysaccharide, jujube seed saponin, γ-aminobutyric acid, and Lactobacillus plantarum P-8 postbiotic in sterile purified water at 73-77℃. First, stir at a low speed of 180-220 r / min for 4-6 min to initially disperse the components, and then stir at a constant temperature of 250-350 r / min for 8-12 min until all components are completely dissolved, resulting in a clear sterile aqueous phase system. Step 3: Then, under constant temperature of 73-77℃ and high-speed shearing of 9000-11000r / min, the oil phase is added dropwise to the water phase at a uniform rate for 3-5 minutes, and shearing emulsification is continued for 4-6 minutes to prepare a uniform and stable O / W type primary emulsion with no layering and no floating oil. Step 4: Keep the system at a constant temperature of 70-75℃, first pre-homogenize at a pressure of 250-350 bar 1-3 times, then continuously homogenize at a rated working pressure of 550-650 bar 4-6 times, with each homogenization cycle lasting 1.5-2.5 min, to prepare a nano-suspension, and control the PDI of the suspension to be ≤0.

25. Step 5: After homogenization, the suspension is gradually cooled and solidified. First, it is kept at 55-65℃ for 4-6 minutes, then cooled at a uniform rate to 20-25℃, and finally allowed to stand at 3-5℃ for 25-35 minutes to promote stable crystallization of the lipid skeleton. After solidification, it is filtered under pressure through a 0.22μm sterile organic microporous filter membrane to remove large particles and free impurities. Step 6: Add 8% to 10% freeze-drying protectant to the filtered high-purity suspension, and vacuum seal after freeze-drying to obtain a loose, porous solid lipid nanoparticle powder with excellent resolubility. Step 7: The prepared solid lipid nanoparticles have a particle size of 80-120 nm, a zeta potential of -25 to -35 mV, an encapsulation rate of active ingredients ≥92%, and a moisture content ≤3.0%.

6. The Ganoderma lucidum nervonic acid composition for promoting sleep and combating depression according to claim 5, characterized in that, In step six, the freeze-drying protectant is a mixture of mannitol and sucrose in a mass ratio of 2:

1.

7. The Ganoderma lucidum nervonic acid composition for promoting sleep and combating depression according to claim 5, characterized in that, In step six, during the freeze-drying process, the pre-freezing temperature is set to -48 to -42℃, the pre-freezing time is 3 to 5 hours, the vacuum degree is maintained at 10 to 15 Pa, the primary drying temperature is -32 to -28℃, the drying time is 10 to 14 hours, and the secondary drying temperature is 8 to 12℃, the drying time is 5 to 7 hours.

8. The sleep-promoting and antidepressant nervonic acid Ganoderma lucidum composition according to claim 1, characterized in that, The excipients are pharmaceutically or food-grade acceptable, and the total weight is 20 to 60 parts, accounting for 15% to 35% of the total mass of the composition. The excipients include one or more of the following: 15 to 40 parts microcrystalline cellulose, 0 to 15 parts maltodextrin, and 0.5 to 5 parts magnesium stearate.

9. The Ganoderma lucidum nervonic acid composition for promoting sleep and combating depression according to claim 1, characterized in that, The composition is available in the form of tablets, capsules, granules, or oral liquid.

10. The use of the composition according to any one of claims 1-9 in the preparation of a medicament or health food for promoting sleep, antidepressant, and improving comorbid insomnia and depression.