Ganoderma lucidum raw plasma composition for improving sleep and preparation method thereof

Abstract

The present application belongs to the technical field of fermentation, and discloses a ganoderma lucidum original pulp composition for improving sleep and a preparation method thereof. The ganoderma lucidum original pulp composition for improving sleep is prepared from the following components in parts by weight: ganoderma lucidum original pulp 35-45 parts, phellinus igniarius 8-12 parts, polygonatum 12-18 parts, astragalus 12-18 parts, zizyphus jujuba mill 4-6 parts, poria cocos 8-12 parts, lily 8-12 parts, and gamma-aminobutyric acid 0.2-0.3 parts. The ganoderma lucidum original pulp composition can effectively shorten the sleep time, prolong the sleep time, and improve the sleep depth, has no chemical sedative components, has no dependence and no obvious side effects, and is suitable for long-term insomnia people. The ganoderma lucidum original pulp composition has significant advantages in improving sleep-related symptoms, and has high clinical application prospect and market promotion value.

Description

Technical Field

[0001] This invention belongs to the field of fermentation technology and relates to a Ganoderma lucidum extract composition for improving sleep and its preparation method. Background Technology

[0002] Insomnia is a subjective experience where patients are dissatisfied with their sleep duration and / or quality, which affects their daytime social functioning. It manifests as difficulties in initiating or maintaining sleep, and premature awakening, leading to daytime lethargy, poor concentration, mood swings, and memory decline. The occurrence of insomnia is related to central nervous system hormones such as serotonin, norepinephrine, dopamine, and gamma-aminobutyric acid (GABA); its main pathological basis is excessive arousal, manifested as abnormal cortisol secretion, sympathetic nerve excitation, and hypothalamic-pituitary-adrenal axis dysfunction.

[0003] Treatment for insomnia primarily includes pharmacological and non-pharmacological approaches. Benzodiazepines, benzodiazepine receptor agonists, and certain antidepressants are currently the most commonly prescribed medications for insomnia. Although pharmacological treatments are relatively fast-acting and have clear efficacy, long-term use has certain side effects, including potential drug dependence, withdrawal symptoms, daytime residual effects (such as drowsiness and cognitive decline), and tolerance issues. Therefore, patients often resist medication, resulting in low adherence. Non-pharmacological treatments refer to other therapies besides pharmacological treatment, including physical therapy, psychotherapy, and traditional Chinese medicine, which have positive effects on regulating nerve function, altering patient cognition, and improving sleep quality.

[0004] Developing safe and effective products for treating insomnia is essential for preventing and treating insomnia. Summary of the Invention

[0005] In view of this, the present invention provides a Ganoderma lucidum extract composition for improving sleep and its preparation method. The Ganoderma lucidum extract composition for improving sleep is prepared from the following components: Ganoderma lucidum extract, Phellinus linteus, Polygonatum sibiricum, Astragalus membranaceus, Ziziphus jujuba var. spinosa, Poria cocos, Lilium brownii, and γ-aminobutyric acid (GABA). The ingredients in the Ganoderma lucidum extract composition of the present invention work synergistically to alleviate difficulty falling asleep, reduce nighttime awakenings, improve sleep quality, and have no obvious side effects, making it suitable for long-term conditioning.

[0006] The sleep-improving Ganoderma lucidum extract composition of the present invention is prepared from the following components by weight: 35-45 parts of Ganoderma lucidum extract, 8-12 parts of Phellinus linteus, 12-18 parts of Polygonatum sibiricum, 12-18 parts of Astragalus membranaceus, 4-6 parts of Ziziphus jujuba var. spinosa, 8-12 parts of Poria cocos, 8-12 parts of Lilium brownii, and 0.2-0.3 parts of γ-aminobutyric acid.

[0007] In one embodiment of the present invention, the sleep-improving Ganoderma lucidum extract composition is prepared by weight of the following components: 35 parts Ganoderma lucidum extract, 12 parts Phellinus linteus, 15 parts Polygonatum sibiricum, 18 parts Astragalus membranaceus, 4 parts Ziziphus jujuba var. spinosa, 12 parts Poria cocos, 8 parts Lilium brownii, and 0.2 parts γ-aminobutyric acid.

[0008] In one embodiment of the present invention, the sleep-improving Ganoderma lucidum extract composition is prepared by weight of the following components: 40 parts Ganoderma lucidum extract, 8 parts Phellinus linteus, 12 parts Polygonatum sibiricum, 15 parts Astragalus membranaceus, 5 parts Ziziphus jujuba var. spinosa, 8 parts Poria cocos, 10 parts Lilium brownii, and 0.3 parts γ-aminobutyric acid.

[0009] In one embodiment of the present invention, the sleep-improving Ganoderma lucidum extract composition is prepared by weight of the following components: 45 parts Ganoderma lucidum extract, 10 parts Phellinus linteus, 18 parts Polygonatum sibiricum, 12 parts Astragalus membranaceus, 6 parts Ziziphus jujuba var. spinosa, 12 parts Poria cocos, 8 parts Lilium brownii, and 0.2 parts γ-aminobutyric acid.

[0010] The present invention also provides a method for preparing the aforementioned Ganoderma lucidum extract composition for improving sleep, comprising the following steps: (1) Extract Ganoderma lucidum with water, filter, and obtain Ganoderma lucidum extract; (2) Add water to extract Sanghuang, lily, astragalus and polygonatum, filter, combine the water extracts to obtain extract I; (3) After crushing Poria cocos and Ziziphus jujuba seeds, add water and mix, add compound probiotics for fermentation, filter after fermentation to obtain fermentation liquid I; (4) Mix the Ganoderma lucidum syrup obtained in step (1), extract I obtained in step (2), and fermentation broth I obtained in step (3), sterilize, add γ-aminobutyric acid, mix, and obtain the final product.

[0011] In one embodiment of the present invention, in step (1), water is added for extraction twice. The first extraction is carried out with 8-10 times the weight of Ganoderma lucidum and water is added for 1-2 hours. The second extraction is carried out with 6-8 times the weight of Ganoderma lucidum and water is added for 0.5-1 hours.

[0012] In one embodiment of the present invention, step (2) involves two extractions with water. The first extraction is performed with 10-12 times the total mass of Sanghuang, lily, astragalus, and polygonatum, and is carried out for 1-2 hours. The second extraction is performed with 8-10 times the total mass of Sanghuang, lily, astragalus, and polygonatum, and is carried out for 0.5-1 hours.

[0013] In one embodiment of the present invention, in step (3), the amount of water added is 15-20 times the mass of Poria cocos and Ziziphus jujuba seeds, and compound probiotics are inoculated at 2%-3% (v / v). Fermentation is carried out at 28±1℃, anaerobic conditions, and 0.02-0.03MPa for 48-72 hours until the pH of the fermentation broth is 4.2-4.5 and the viable count is ≥1.0×10⁻⁶. 8CFU / mL, yielding fermentation broth I; the compound probiotics are composed of Lactobacillus casei, Bifidobacterium, and Streptococcus thermophilus in a mass ratio of 2:1:3, with a total viable count of ≥1.0×10⁻⁶. 10 CFU / g.

[0014] In one embodiment of the present invention, water extraction is performed twice in step (1). The first extraction is performed with 10 times the weight of Ganoderma lucidum in water for 1 hour, and the second extraction is performed with 8 times the weight of Ganoderma lucidum in water for 1 hour. In step (2), water is added twice. The first extraction is carried out with 12 times the total mass of Sanghuang, lily, astragalus and polygonatum for 1.5 hours. The second extraction is carried out with 10 times the total mass of Sanghuang, lily, astragalus and polygonatum for 1 hour. In step (3), the amount of water added is 15 times the mass of Poria cocos and Ziziphus jujuba seeds. Compound probiotics are inoculated at 2% concentration, and fermentation is carried out at 28℃, anaerobic conditions, and 0.02 MPa for 48 hours until the pH of the fermentation broth reaches 4.2 and the viable cell count reaches 1.0 × 10⁻⁶. 8 CFU / mL, yielding fermentation broth I; the compound probiotics were composed of Lactobacillus casei, Bifidobacterium, and Streptococcus thermophilus in a mass ratio of 2:1:3, with a total viable count of 1.0 × 10⁻⁶ CFU / mL. 10 CFU / g.

[0015] The present invention also provides the use of the aforementioned Ganoderma lucidum extract composition for improving sleep in the preparation of products for improving sleep.

[0016] Compared with the prior art, the present invention has the following advantages: The ingredients in this invention's Ganoderma lucidum extract composition work synergistically to achieve a comprehensive effect in treating insomnia. Ganoderma lucidum can calm the nerves, relieve nervous tension, and improve difficulty falling asleep; Phellinus linteus, Astragalus membranaceus, Lilium brownii, and Polygonatum sibiricum nourish Qi and Yin, soothe emotions, and reduce the number of nighttime awakenings; Poria cocos and Ziziphus jujuba var. spinosa are fermented with compound probiotics, making their active ingredients easier to absorb, and the probiotics can regulate the balance of intestinal flora, further improving sleep quality through the gut-brain axis.

[0017] Animal experiments showed that administering the Ganoderma lucidum extract composition of this invention to sleep-improving mice significantly shortened sleep latency and prolonged sleep duration, indicating that the Ganoderma lucidum extract composition of this invention has a significant effect on improving sleep. Administering the Ganoderma lucidum extract composition of this invention to sub-healthy mice with heart and spleen deficiency and insomnia also significantly shortened sleep latency and prolonged sleep duration, indicating that the Ganoderma lucidum extract composition of this invention has a significant effect on improving sleep in sub-healthy mice with heart and spleen deficiency.

[0018] The Ganoderma lucidum extract composition of this invention can effectively shorten the time to fall asleep, prolong sleep time, and improve sleep depth. It contains no chemical sedative ingredients, is non-addictive, and has no obvious side effects, making it suitable for people with long-term insomnia.

[0019] The Ganoderma lucidum extract composition of the present invention has significant advantages in improving sleep and has high clinical application prospects and market promotion value. Attached Figure Description

[0020] Figure 1 Comparison of sleep latency among different groups of mice. Note: Compared with the blank control group. & P <0.05, && P <0.01; compared with the model control group, * P <0.05,** P <0.01; compared with Example 1 group, # P <0.05, ## P <0.01.

[0021] Figure 2 Comparison of sleep duration among different groups of mice. Note: Compared with the blank control group. & P <0.05, && P <0.01; compared with the model control group, * P <0.05,** P <0.01; compared with Example 1 group, # P <0.05, ## P <0.01.

[0022] Figure 3 Effects on sleep latency in sub-healthy mice with heart and spleen deficiency and insomnia. Note: Compared with the blank control group, & P <0.05, && P <0.01; compared with the model control group, * P <0.05,** P <0.01; compared with Example 1 group, # P <0.05, ## P <0.01.

[0023] Figure 4 Effects on sleep duration in sub-healthy mice with heart and spleen deficiency and insomnia. Note: Compared with the blank control group, & P <0.05, && P <0.01; compared with the model control group, * P<0.05,** P <0.01; compared with Example 1 group, # P <0.05, ## P <0.01. Detailed Implementation

[0024] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0025] Unless otherwise specified, all reagents involved in the embodiments of this invention are commercially available products and can be purchased through commercial channels.

[0026] Example 1 A Ganoderma lucidum extract composition for improving sleep comprises the following raw materials in parts by weight: 35 parts of Ganoderma lucidum extract, 12 parts of Phellinus linteus, 15 parts of Polygonatum sibiricum, 18 parts of Astragalus membranaceus, 4 parts of Ziziphus jujuba var. spinosa, 12 parts of Poria cocos, 8 parts of Lilium brownii, and 0.2 parts of γ-aminobutyric acid.

[0027] The preparation method is as follows: (1) Extract Ganoderma lucidum with water, filter, and obtain Ganoderma lucidum extract; (2) Add water to extract Sanghuang, lily, astragalus and polygonatum, filter, combine the water extracts to obtain extract I; (3) After crushing Poria cocos and Ziziphus jujuba seeds, add water and mix, add compound probiotics for fermentation, filter after fermentation to obtain fermentation liquid I; (4) Mix the Ganoderma lucidum syrup obtained in step (1), extract I obtained in step (2), and fermentation broth I obtained in step (3), sterilize, add γ-aminobutyric acid, mix, and obtain the final product.

[0028] In step (1), water was added twice for extraction. The first extraction was done with 10 times the weight of Ganoderma lucidum in water for 1 hour, and the second extraction was done with 8 times the weight of Ganoderma lucidum in water for 1 hour.

[0029] In step (2), water is added twice. The first extraction is carried out with 12 times the total mass of Sanghuang, lily, astragalus and polygonatum in water for 1.5 hours. The second extraction is carried out with 10 times the total mass of Sanghuang, lily, astragalus and polygonatum in water for 1 hour.

[0030] In step (3), the amount of water added is 15 times the mass of Poria cocos and Ziziphus jujuba seeds. Compound probiotics are inoculated at 2% (v / v), and fermentation is carried out at 28℃, anaerobic conditions, and 0.02 MPa for 48 hours until the pH of the fermentation broth reaches 4.2 and the viable cell count reaches 1.0 × 10⁻⁶. 8 CFU / mL yielded fermentation broth I; the compound probiotics were composed of Lactobacillus casei, Bifidobacterium, and Streptococcus thermophilus in a mass ratio of 2:1:3, with a total viable count of 1.0 × 10⁻⁶. 10 CFU / g.

[0031] Example 2 A Ganoderma lucidum extract composition for improving sleep comprises the following raw materials in parts by weight: 40 parts of Ganoderma lucidum extract, 8 parts of Phellinus linteus, 12 parts of Polygonatum sibiricum, 15 parts of Astragalus membranaceus, 5 parts of Ziziphus jujuba var. spinosa, 8 parts of Poria cocos, 10 parts of Lilium brownii, and 0.3 parts of γ-aminobutyric acid.

[0032] The preparation method is as follows: (1) Extract Ganoderma lucidum with water, filter, and obtain Ganoderma lucidum extract; (2) Add water to extract Sanghuang, lily, astragalus and polygonatum, filter, combine the water extracts to obtain extract I; (3) After crushing Poria cocos and Ziziphus jujuba seeds, add water and mix, add compound probiotics for fermentation, filter after fermentation to obtain fermentation liquid I; (4) Mix the Ganoderma lucidum syrup obtained in step (1), extract I obtained in step (2), and fermentation broth I obtained in step (3), sterilize, add γ-aminobutyric acid, mix, and obtain the final product.

[0033] In step (1), water was added twice for extraction. The first extraction was done with 8 times the weight of Ganoderma lucidum in water for 1 hour, and the second extraction was done with 8 times the weight of Ganoderma lucidum in water for 0.5 hours.

[0034] In step (2), water is added twice. The first time, water is added at 10 times the total mass of Sanghuang, lily, astragalus and polygonatum for 1 hour. The second time, water is added at 10 times the total mass of Sanghuang, lily, astragalus and polygonatum for 1 hour.

[0035] In step (3), the amount of water added is 20 times the mass of Poria cocos and Ziziphus jujuba seeds. Compound probiotics are inoculated at 2% (v / v), and fermentation is carried out at 27℃, anaerobic conditions, and 0.03 MPa for 48 hours until the pH of the fermentation broth reaches 4.5 and the viable cell count reaches 1.0 × 10⁻⁶. 8 CFU / mL yielded fermentation broth I; the compound probiotics were composed of Lactobacillus casei, Bifidobacterium, and Streptococcus thermophilus in a mass ratio of 2:1:3, with a total viable count of 1.0 × 10⁻⁶. 10 CFU / g.

[0036] Example 3 A Ganoderma lucidum extract composition for improving sleep comprises the following raw materials in parts by weight: 45 parts of Ganoderma lucidum extract, 10 parts of Phellinus linteus, 18 parts of Polygonatum sibiricum, 12 parts of Astragalus membranaceus, 6 parts of Ziziphus jujuba var. spinosa, 12 parts of Poria cocos, 8 parts of Lilium brownii, and 0.2 parts of γ-aminobutyric acid.

[0037] The preparation method is as follows: (1) Extract Ganoderma lucidum with water, filter, and obtain Ganoderma lucidum extract; (2) Add water to extract Sanghuang, lily, astragalus and polygonatum, filter, combine the water extracts to obtain extract I; (3) After crushing Poria cocos and Ziziphus jujuba seeds, add water and mix, add compound probiotics for fermentation, filter after fermentation to obtain fermentation liquid I; (4) Mix the Ganoderma lucidum syrup obtained in step (1), extract I obtained in step (2), and fermentation broth I obtained in step (3), sterilize, add γ-aminobutyric acid, mix, and obtain the final product.

[0038] In step (1), water was added twice for extraction. The first extraction was done with 10 times the weight of Ganoderma lucidum in water for 2 hours, and the second extraction was done with 6 times the weight of Ganoderma lucidum in water for 0.5 hours.

[0039] In step (2), water is added twice. The first extraction is carried out with 12 times the total mass of Sanghuang, lily, astragalus and polygonatum, for 2 hours. The second extraction is carried out with 10 times the total mass of Sanghuang, lily, astragalus and polygonatum, for 0.5 hours.

[0040] In step (3), the amount of water added is 15 times the mass of Poria cocos and Ziziphus jujuba seeds. Compound probiotics are inoculated at 3% (v / v), and fermentation is carried out at 29℃, anaerobic conditions, and 0.02 MPa for 72 hours until the pH of the fermentation broth reaches 4.2 and the viable cell count reaches 1.0 × 10⁻⁶. 8 CFU / mL yielded fermentation broth I; the compound probiotics were composed of Lactobacillus casei, Bifidobacterium, and Streptococcus thermophilus in a mass ratio of 2:1:3, with a total viable count of 1.0 × 10⁻⁶. 10 CFU / g.

[0041] Example 4 A Ganoderma lucidum extract composition for improving sleep comprises the following raw materials in parts by weight: 45 parts of Ganoderma lucidum extract, 12 parts of Phellinus linteus, 12 parts of Polygonatum sibiricum, 15 parts of Astragalus membranaceus, 5 parts of Ziziphus jujuba var. spinosa, 12 parts of Poria cocos, 10 parts of Lilium brownii, and 0.2 parts of γ-aminobutyric acid.

[0042] The preparation method is as follows: (1) Extract Ganoderma lucidum with water, filter, and obtain Ganoderma lucidum extract; (2) Add water to extract Sanghuang, lily, astragalus and polygonatum, filter, combine the water extracts to obtain extract I; (3) After crushing Poria cocos and Ziziphus jujuba seeds, add water and mix, add compound probiotics for fermentation, filter after fermentation to obtain fermentation liquid I; (4) Mix the Ganoderma lucidum syrup obtained in step (1), extract I obtained in step (2), and fermentation broth I obtained in step (3), sterilize, add γ-aminobutyric acid, mix, and obtain the final product.

[0043] In step (1), water was added twice for extraction. The first extraction was carried out with 8 times the weight of Ganoderma lucidum in water for 1.5 hours, and the second extraction was carried out with 8 times the weight of Ganoderma lucidum in water for 0.5 hours.

[0044] In step (2), water is added twice. The first extraction is carried out with 10 times the total mass of Sanghuang, lily, astragalus and polygonatum in water for 1 hour. The second extraction is carried out with 10 times the total mass of Sanghuang, lily, astragalus and polygonatum in water for 0.5 hours.

[0045] In step (3), the amount of water added is 15 times the mass of Poria cocos and Ziziphus jujuba seeds. Compound probiotics are inoculated at 3% (v / v), and fermentation is carried out at 28℃, anaerobic conditions, and 0.03 MPa for 48 hours until the pH of the fermentation broth reaches 4.5 and the viable cell count reaches 1.0 × 10⁻⁶. 8 CFU / mL yielded fermentation broth I; the compound probiotics were composed of Lactobacillus casei, Bifidobacterium, and Streptococcus thermophilus in a mass ratio of 2:1:3, with a total viable count of 1.0 × 10⁻⁶. 10 CFU / g.

[0046] Example 5 A Ganoderma lucidum extract composition for improving sleep comprises the following raw materials in parts by weight: 40 parts of Ganoderma lucidum extract, 8 parts of Phellinus linteus, 15 parts of Polygonatum sibiricum, 12 parts of Astragalus membranaceus, 5 parts of Ziziphus jujuba var. spinosa, 8 parts of Poria cocos, 10 parts of Lilium brownii, and 0.3 parts of γ-aminobutyric acid.

[0047] The preparation method is the same as in Example 1.

[0048] Example 6 A Ganoderma lucidum extract composition for improving sleep comprises the following raw materials in parts by weight: 45 parts of Ganoderma lucidum extract, 10 parts of Phellinus linteus, 18 parts of Polygonatum sibiricum, 15 parts of Astragalus membranaceus, 6 parts of Ziziphus jujuba var. spinosa, 10 parts of Poria cocos, 12 parts of Lilium brownii, and 0.2 parts of γ-aminobutyric acid.

[0049] The preparation method is the same as in Example 2.

[0050] Example 7 A Ganoderma lucidum extract composition for improving sleep comprises the following raw materials in parts by weight: 35 parts of Ganoderma lucidum extract, 12 parts of Phellinus linteus, 15 parts of Polygonatum sibiricum, 15 parts of Astragalus membranaceus, 5 parts of Ziziphus jujuba var. spinosa, 8 parts of Poria cocos, 12 parts of Lilium brownii, and 0.2 parts of γ-aminobutyric acid.

[0051] The preparation method is the same as in Example 3.

[0052] Comparative Example 1 18 parts of Phellinus linteus, 21 parts of Polygonatum sibiricum, 24 parts of Astragalus membranaceus, 10 parts of Ziziphus jujuba var. spinosa, 18 parts of Poria cocos, 13 parts of Lilium brownii, and 0.2 parts of γ-aminobutyric acid.

[0053] Compared with Example 1, the difference is that it does not contain Ganoderma lucidum extract and the amount of other components is increased.

[0054] The preparation method is the same as in Example 1.

[0055] Comparative Example 2 35 parts of Ganoderma lucidum extract, 21 parts of Polygonatum sibiricum, 18 parts of Astragalus membranaceus, 4 parts of Ziziphus jujuba var. spinosa, 12 parts of Poria cocos, 14 parts of Lilium brownii, and 0.2 parts of γ-aminobutyric acid.

[0056] Compared with Example 1, the difference is that Phellinus linteus is omitted and the amount of Polygonatum sibiricum and lily bulb is increased.

[0057] The preparation method is the same as in Example 1.

[0058] Comparative Example 3 35 parts of Ganoderma lucidum extract, 20 parts of Phellinus linteus, 15 parts of Polygonatum sibiricum, 4 parts of Ziziphus jujuba var. spinosa, 22 parts of Poria cocos, 8 parts of lily bulb, and 0.2 parts of γ-aminobutyric acid.

[0059] Compared with Example 1, the difference is that Astragalus membranaceus is omitted and the dosage of Phellinus linteus and Poria cocos is increased.

[0060] The preparation method is the same as in Example 1.

[0061] Comparative Example 4 49 parts of Ganoderma lucidum extract, 15 parts of Phellinus linteus, 10 parts of Polygonatum sibiricum, 10 parts of Astragalus membranaceus, 8 parts of Ziziphus jujuba var. spinosa, 6 parts of Poria cocos, 6 parts of Lilium brownii, and 0.2 parts of γ-aminobutyric acid.

[0062] Compared with Example 1, the difference lies in changing the amount of each component.

[0063] The preparation method is the same as in Example 1.

[0064] Comparative Example 5 30 parts Ganoderma lucidum extract, 15 parts Phellinus linteus, 20 parts Polygonatum sibiricum, 10 parts Astragalus membranaceus, 11 parts Ziziphus jujuba var. spinosa, 15 parts Poria cocos, 5 parts Lilium brownii, and 0.2 parts Gamma-aminobutyric acid.

[0065] Compared with Example 1, the difference lies in changing the amount of each component.

[0066] The preparation method is the same as in Example 1.

[0067] Comparative Example 6 35 parts of Ganoderma lucidum extract, 12 parts of Phellinus linteus, 15 parts of Polygonatum sibiricum, 18 parts of Astragalus membranaceus, 4 parts of Ziziphus jujuba var. spinosa, 12 parts of Poria cocos, 8 parts of Lilium brownii, and 0.2 parts of γ-aminobutyric acid.

[0068] Compared with Example 1, the difference is that Poria cocos and Ziziphus jujuba seeds are not fermented, and the preparation of Poria cocos and Ziziphus jujuba seeds is changed from fermentation to water extraction.

[0069] The preparation method is as follows: (1) Extract Ganoderma lucidum with water, filter, and obtain Ganoderma lucidum extract; (2) Add water to extract Sanghuang, lily, astragalus and polygonatum, filter, combine the water extracts to obtain extract I; (3) Add water to extract Poria cocos and Ziziphus jujuba seeds, filter, combine the water extracts to obtain the extract; (4) Mix the Ganoderma lucidum extract obtained in step (1), extract I obtained in step (2), and extract obtained in step (3), sterilize, add γ-aminobutyric acid, mix, and obtain the final product.

[0070] In step (1), water was added twice for extraction. The first extraction was done with 10 times the weight of Ganoderma lucidum in water for 1 hour, and the second extraction was done with 8 times the weight of Ganoderma lucidum in water for 1 hour.

[0071] In step (2), water is added twice. The first extraction is carried out with 12 times the total mass of Sanghuang, lily, astragalus and polygonatum in water for 1.5 hours. The second extraction is carried out with 10 times the total mass of Sanghuang, lily, astragalus and polygonatum in water for 1 hour.

[0072] In step (3), water was added twice for extraction. The first extraction was carried out with 12 times the total mass of Poria cocos and Ziziphus jujuba var. spinosa, and the second extraction was carried out with 10 times the total mass of Poria cocos and Ziziphus jujuba var. spinosa, and the extraction was carried out for 1 hour.

[0073] Comparative Example 7 35 parts of Ganoderma lucidum extract, 12 parts of Phellinus linteus, 15 parts of Polygonatum sibiricum, 18 parts of Astragalus membranaceus, 4 parts of Ziziphus jujuba var. spinosa, 12 parts of Poria cocos, 8 parts of Lilium brownii, and 0.2 parts of γ-aminobutyric acid.

[0074] Compared with Example 1, the difference lies in the change of the fermentation strains of Poria cocos and Ziziphus jujuba seeds.

[0075] In step (3), the amount of water added is 15 times the mass of Poria cocos and Ziziphus jujuba seeds. Compound probiotics are inoculated at 2% (v / v), and fermentation is carried out at 28℃, anaerobic conditions, and 0.02 MPa for 48 hours until the pH of the fermentation broth reaches 4.2 and the viable cell count reaches 1.0 × 10⁻⁶. 8 CFU / mL yielded fermentation broth I; the compound probiotics were composed of Bifidobacterium and Streptococcus thermophilus in a 3:3 mass ratio, with a total viable count of 1.0 × 10⁻⁶ CFU / mL. 10 CFU / g.

[0076] Comparative Example 8 35 parts of Ganoderma lucidum extract, 12 parts of Phellinus linteus, 15 parts of Polygonatum sibiricum, 18 parts of Astragalus membranaceus, 4 parts of Ziziphus jujuba var. spinosa, 12 parts of Poria cocos, 8 parts of Lilium brownii, and 0.2 parts of γ-aminobutyric acid.

[0077] Compared with Example 1, the difference lies in the change of the fermentation strains of Poria cocos and Ziziphus jujuba seeds.

[0078] In step (3), the amount of water added is 15 times the mass of Poria cocos and Ziziphus jujuba seeds. Compound probiotics are inoculated at 2% (v / v), and fermentation is carried out at 28℃, anaerobic conditions, and 0.02 MPa for 48 hours until the pH of the fermentation broth reaches 4.2 and the viable cell count reaches 1.0 × 10⁻⁶. 8 CFU / mL yielded fermentation broth I; the compound probiotics were composed of Lactobacillus plantarum, Lactobacillus casei, and Bifidobacterium in a mass ratio of 2:1:3, with a total viable count of 1.0 × 10⁻⁶ CFU / mL. 10 CFU / g.

[0079] Comparative Example 9 35 parts of Ganoderma lucidum extract, 12 parts of Phellinus linteus, 15 parts of Polygonatum sibiricum, 18 parts of Astragalus membranaceus, 4 parts of Ziziphus jujuba var. spinosa, 12 parts of Poria cocos, 8 parts of Lilium brownii, and 0.2 parts of γ-aminobutyric acid.

[0080] Compared with Example 1, the difference lies in the change of the fermentation strains of Poria cocos and Ziziphus jujuba seeds.

[0081] In step (3), the amount of water added is 15 times the mass of Poria cocos and Ziziphus jujuba seeds. Compound probiotics are inoculated at 2% (v / v), and fermentation is carried out at 28℃, anaerobic conditions, and 0.02 MPa for 48 hours until the pH of the fermentation broth reaches 4.2 and the viable cell count reaches 1.0 × 10⁻⁶. 8 CFU / mL yielded fermentation broth I; the compound probiotics were composed of Lactobacillus plantarum, Lactobacillus rhamnosus, and Streptococcus thermophilus in a mass ratio of 2:1:3, with a total viable count of 1.0 × 10⁻⁶ CFU / mL. 10 CFU / g.

[0082] Study on the effect of the Ganoderma lucidum extract composition of the present invention on sleeping mice 1. Establishment of a mouse sleep model SPF-grade ICR mice, weighing 18-22g, were acclimatized for 7 days and then randomly divided into a blank control group (8 mice) and a model group (80 mice) using a random number table.

[0083] Mice in the model group were injected intraperitoneally with PCPA solution (400 mg / kg, prepared with 0.5% sodium carboxymethyl cellulose solution) for 2 consecutive days. The control group was injected intraperitoneally with an equal volume of 0.5% sodium carboxymethyl cellulose solution. The behavior of the mice was observed. If irritability, sparse fur, or loss of diurnal rhythm appeared, the success of the model was determined.

[0084] After successfully constructing the model, the mice in the model group were randomly divided into a model control group, Example 1-3 groups, Comparative Example 1-5 groups, and a positive drug group, with 8 mice in each group.

[0085] Groups 1-3 were administered 200 mg / kg of the Ganoderma lucidum extract composition of Examples 1-3 via gavage, and groups 1-5 were administered 200 mg / kg of the composition of Comparative Examples 1-5 via gavage. The positive control group was administered 8.91 g / kg of Bailuomian capsules (Yangtze River Pharmaceutical Group) via gavage once daily. The blank control group and the model control group were administered an equal volume of pure water via gavage. The administration was continued for 7 days.

[0086] 2. Indicator Testing One hour after the last oral administration, each group of animals was injected intraperitoneally with 350 mg / kg of tribromide.

[0087] Preparation of tribromoaqueous solution: Mix 25g of tribromoaqueous solution with 15.5mL of tert-amyl alcohol and dissolve at room temperature for 2 hours to prepare a stock solution of 1600mg / mL. Before use, dilute with physiological saline to prepare a working solution of 35mg / mL and store away from light.

[0088] Record the sleep latency, which is the time from drug administration to the disappearance of the righting reflex in mice. The disappearance of the righting reflex is defined as the mice remaining in a supine position for more than 60 seconds. Record the sleep duration, which is the time from the disappearance of the righting reflex to its recovery.

[0089] 3. Statistical Methods One-way ANOVA was performed using GraphPad Prism 8.0 to analyze differences between groups. All experimental data are expressed as mean ± standard deviation.

[0090] 4. Experimental Results Comparison of sleep latency and sleep duration among different groups of mice Table 1 Comparison of sleep latency in mice of different groups

[0091] Note: Compared with the blank control group, & P <0.05, && P <0.01; compared with the model control group, * P <0.05,** P <0.01; compared with Example 1 group, # P <0.05, ## P <0.01.

[0092] Table 2 Comparison of sleep duration among different groups of mice

[0093] Note: Compared with the blank control group, & P <0.05, && P <0.01; compared with the model control group, * P <0.05,** P <0.01; compared with Example 1 group, # P <0.05, ## P <0.01.

[0094] Compared with the blank control group, the sleep latency of mice in the model control group was significantly prolonged and the sleep duration was significantly shortened.

[0095] Compared with the model control group, the sleep latency of mice in each group of the examples was significantly shortened and the sleep duration was significantly prolonged. Compared with comparative groups 1-5, the sleep latency of each group of the examples was shorter and the sleep duration was longer. The results show that the Ganoderma lucidum extract composition of the present invention has a good sleep-inducing effect on insomnia model mice. The results are shown in Tables 1 and 2. Figure 1 , Figure 2 .

[0096] Comparative Example 1 did not contain Ganoderma lucidum extract, Comparative Example 2 omitted Phellinus linteus, Comparative Example 3 omitted Astragalus membranaceus, Comparative Example 4 changed the amount of each component, Comparative Example 5 changed the preparation method, Poria cocos was not enzymatically hydrolyzed, Polygonatum sibiricum was not fermented, and both Poria cocos and Polygonatum sibiricum were extracted with water. The improvement effects of comparative examples 1-5 on sleep latency and sleep duration were not as good as those of the groups in the examples.

[0097] When mice were given the Ganoderma lucidum extract composition of the present invention to improve sleep, the sleep latency of the mice was significantly shortened and the sleep duration was significantly prolonged, indicating that the Ganoderma lucidum extract composition of the present invention has a significant effect on improving sleep.

[0098] Study on the effects of the Ganoderma lucidum extract composition of this invention on sub-healthy mice with insomnia due to deficiency of both heart and spleen. 1. Establishment of a mouse sleep model SPF-grade ICR mice, weighing 18-22g, were acclimatized for 7 days and then randomly divided into four groups (n=8 per group): a blank control group, a model control group, Example 1 group, and Comparative Examples 6-9 groups. Example 1 group received 200mg / kg of the Ganoderma lucidum extract composition from Example 1 via gavage. Comparative Examples 6-9 groups received 200mg / kg of the composition from Comparative Examples 6-9 via gavage once daily. The blank control group and the model control group received an equal volume of pure water via gavage. This gavage treatment continued for 30 days.

[0099] After 7 days of adaptive feeding, the model was established as follows: ① Exhaustive weight-bearing swimming: Starting from day 16 of gavage, 1 hour after the end of gavage administration, all groups except the blank control group underwent exhaustive weight-bearing swimming exercises. The weight was 5% of the body weight. The criteria for exhaustive swimming were: mice exhibited motor incoordination, their heads could not float to the surface, and they remained submerged for more than 5-8 seconds without surfacing. The mice were immediately removed from the water. ② From day 27 to 30 of gavage, the blank control group was given 0.9% sodium chloride solution every afternoon, while the other groups were given propranolol hydrochloride solution 1.5 mL / 100 g once daily for 4 consecutive days.

[0100] 2. Indicator Testing Experiment on prolonging sodium pentobarbital-induced sleep time in mice Following the last administration, mice in each group were intraperitoneally injected with 55 mg / kg body weight of sodium pentobarbital, at a dose of 0.1 mL / 10 g. The absence of the righting reflex was used as the criterion to observe whether the test drug prolonged the sleep time induced by sodium pentobarbital.

[0101] Sodium barbital sleep latency test Following the last administration, mice in each group were intraperitoneally injected with 300 mg / kg sodium barbital (0.1 mL / 10 g). The absence of the righting reflex in mice was used as a positive indicator to observe the effect of the test substance on the sleep latency of sodium barbital.

[0102] 3. Statistical Methods One-way ANOVA was performed using GraphPad Prism 8.0 to analyze differences between groups. All experimental data are expressed as mean ± standard deviation.

[0103] 4. Experimental Results Comparison of sleep latency and sleep duration among different groups of mice Table 3. Effects on sleep latency in sub-healthy insomnia mice with deficiency of both heart and spleen

[0104] Note: Compared with the blank control group, & P <0.05, && P <0.01; compared with the model control group, * P <0.05,** P <0.01; compared with Example 1 group, # P <0.05, ## P <0.01.

[0105] Table 4. Effects on sleep duration in sub-healthy mice with heart and spleen deficiency and insomnia.

[0106] Note: Compared with the blank control group, & P <0.05, && P <0.01; compared with the model control group, * P <0.05,** P <0.01; compared with Example 1 group, # P <0.05, ## P <0.01.

[0107] Compared with the blank control group, the sleep latency of mice in the model control group was significantly prolonged and the sleep duration was significantly shortened.

[0108] Compared with the model control group, the sleep latency of mice in Example 1 was significantly shortened and the sleep duration was significantly prolonged. Compared with comparative groups 6-9, the sleep latency of Example 1 was even shorter and the sleep duration was even longer. The results indicate that the Ganoderma lucidum extract composition of this invention has a good sleep-inducing effect on sub-healthy insomnia mice with deficiency of both heart and spleen. The results are shown in Tables 3 and 4. Figure 3 , Figure 4 .

[0109] In Comparative Example 6, the preparation of Poria cocos and Ziziphus jujuba seeds was changed from fermentation to water extraction. In Comparative Examples 7-9, the fermentation strains of Poria cocos and Ziziphus jujuba seeds were changed. The improvement effects on sleep latency and sleep duration in Comparative Examples 6-9 were not as good as those in Example 1.

[0110] When mice with sub-health and insomnia due to deficiency of both heart and spleen were given the Ganoderma lucidum extract composition of the present invention to improve sleep, the sleep latency of the mice with sub-health and insomnia due to deficiency of both heart and spleen was significantly shortened and the sleep duration was significantly prolonged, suggesting that the Ganoderma lucidum extract composition of the present invention has a significant effect on improving sleep in sub-healthy mice with deficiency of both heart and spleen.

[0111] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A Ganoderma lucidum extract composition for improving sleep, characterized in that, The sleep-improving Ganoderma lucidum extract composition is prepared by weight of the following components: 35-45 parts Ganoderma lucidum extract, 8-12 parts Phellinus linteus, 12-18 parts Polygonatum sibiricum, 12-18 parts Astragalus membranaceus, 4-6 parts Ziziphus jujuba var. spinosa, 8-12 parts Poria cocos, 8-12 parts Lilium brownii, and 0.2-0.3 parts γ-aminobutyric acid.

2. The Ganoderma lucidum extract composition for improving sleep according to claim 1, characterized in that, The sleep-improving Ganoderma lucidum extract composition is prepared by weight of the following components: 35 parts Ganoderma lucidum extract, 12 parts Phellinus linteus, 15 parts Polygonatum sibiricum, 18 parts Astragalus membranaceus, 4 parts Ziziphus jujuba var. spinosa, 12 parts Poria cocos, 8 parts Lilium brownii, and 0.2 parts γ-aminobutyric acid.

3. The Ganoderma lucidum extract composition for improving sleep according to claim 1, characterized in that, The sleep-improving Ganoderma lucidum extract composition is prepared by weight of the following components: 40 parts Ganoderma lucidum extract, 8 parts Phellinus linteus, 12 parts Polygonatum sibiricum, 15 parts Astragalus membranaceus, 5 parts Ziziphus jujuba var. spinosa, 8 parts Poria cocos, 10 parts Lilium brownii, and 0.3 parts γ-aminobutyric acid.

4. The Ganoderma lucidum extract composition for improving sleep according to claim 1, characterized in that, The sleep-improving Ganoderma lucidum extract composition is prepared by weight of the following components: 45 parts Ganoderma lucidum extract, 10 parts Phellinus linteus, 18 parts Polygonatum sibiricum, 12 parts Astragalus membranaceus, 6 parts Ziziphus jujuba var. spinosa, 12 parts Poria cocos, 8 parts Lilium brownii, and 0.2 parts γ-aminobutyric acid.

5. According to claim 1 4. The method for preparing the Ganoderma lucidum extract composition for improving sleep according to any one of the claims, characterized in that, The method for preparing the Ganoderma lucidum extract composition for improving sleep includes the following steps: (1) Extract Ganoderma lucidum with water, filter, and obtain Ganoderma lucidum extract; (2) Add water to extract Sanghuang, lily, astragalus and polygonatum, filter, combine the water extracts to obtain extract I; (3) After crushing Poria cocos and Ziziphus jujuba seeds, add water and mix, add compound probiotics for fermentation, filter after fermentation to obtain fermentation liquid I; (4) Mix the Ganoderma lucidum syrup obtained in step (1), extract I obtained in step (2), and fermentation broth I obtained in step (3), sterilize, add γ-aminobutyric acid, mix, and obtain the final product.

6. The method for preparing the Ganoderma lucidum extract composition for improving sleep according to claim 5, characterized in that, In step (1), water is added twice. The first extraction is carried out with 8-10 times the weight of Ganoderma lucidum and water is added for 1-2 hours. The second extraction is carried out with 6-8 times the weight of Ganoderma lucidum and water is added for 0.5-1 hours.

7. The method for preparing the Ganoderma lucidum extract composition for improving sleep according to claim 5, characterized in that, In step (2), water is added twice. The first extraction is carried out with 10-12 times the total mass of Sanghuang, lily, astragalus and polygonatum, for 1-2 hours. The second extraction is carried out with 8-10 times the total mass of Sanghuang, lily, astragalus and polygonatum, for 0.5-1 hours.

8. The method for preparing the Ganoderma lucidum extract composition for improving sleep according to claim 5, characterized in that, In step (3), the amount of water added is 15-20 times the mass of Poria cocos and Ziziphus jujuba seeds. Compound probiotics are inoculated at 2%-3% of the solution, and fermentation is carried out at 28±1℃, anaerobic conditions, and 0.02-0.03 MPa for 48-72 hours until the pH of the fermentation broth is 4.2-4.5 and the viable cell count is ≥1.0×10⁻⁶. 8 CFU / mL, yielding fermentation broth I; The compound probiotics are composed of Lactobacillus casei, Bifidobacterium, and Streptococcus thermophilus in a mass ratio of 2:1:3, and the total live bacteria count of the compound probiotics is ≥1.0×10⁻⁶. 10 CFU / g.

9. The method for preparing the Ganoderma lucidum extract composition for improving sleep according to claim 5, characterized in that, In step (1), water is added twice. The first extraction is carried out with 10 times the weight of Ganoderma lucidum in water for 1 hour, and the second extraction is carried out with 8 times the weight of Ganoderma lucidum in water for 1 hour. In step (2), water is added twice. The first extraction is carried out with 12 times the total mass of Sanghuang, lily, astragalus and polygonatum for 1.5 hours. The second extraction is carried out with 10 times the total mass of Sanghuang, lily, astragalus and polygonatum for 1 hour. In step (3), the amount of water added is 15 times the mass of Poria cocos and Ziziphus jujuba seeds. Compound probiotics are inoculated at 2% concentration, and fermentation is carried out at 28℃, anaerobic conditions, and 0.02 MPa for 48 hours until the pH of the fermentation broth reaches 4.2 and the viable cell count is 1.0 × 10⁻⁶. 8 CFU / mL, yielding fermentation broth I; The compound probiotic is composed of Lactobacillus casei, Bifidobacterium, and Streptococcus thermophilus in a mass ratio of 2:1:3, and the total live bacteria count of the compound probiotic is 1.0 × 10⁻⁶. 10 CFU / g.

10. Use of the Ganoderma lucidum extract composition for improving sleep according to claim 1 in the preparation of products for improving sleep.

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