Composition for improving sleep, preventing and treating anxiety and delaying senescence and preparation method thereof

Abstract

The invention discloses a composition for improving sleep, preventing and treating anxiety and delaying senescence and a preparation method thereof. The composition comprises lily, balm, liquorice, mulberry, poria cocos, spina date seed, sea-buckthorn, lotus plumule, roxburgh rose, fructus alpiniae oxyphyllae, valerian root, acanthopanax, red rose, lophatherum gracile, saussurea involucrata, gastrodia elata, passion flower, ergothioneine, dihydroquercetin, gamma-aminobutyric acid, casein peptide, royal jelly, pea peptide, tea theanine, fish collagen peptide and haematococcus pluvialis powder. The composition disclosed by the invention is reasonable in component ratio, convenient to take and carry by a patient and good in effect. In addition, the preparation method of the composition is simple in process, stable and reliable in performance, high in production efficiency, low in production cost and wide in application prospect.

Description

Technical Field

[0001] The present invention relates to the medical field, and in particular to a composition for improving sleep, preventing and treating anxiety, and delaying aging, and a preparation method thereof. Background Art

[0002] The mainstream approach to improving sleep relies on sedatives (such as benzodiazepines), which can promote sleep in the short term, but long-term use can easily lead to drug tolerance, cognitive impairment, and withdrawal reactions; non-drug therapies such as cognitive behavioral therapy require professional guidance and have a long cycle, and patients lack compliance. Natural supplements (such as melatonin) have limited effects on regulating chronic insomnia, and high doses may interfere with endocrine balance.

[0003] Anti-anxiety drugs are mainly selective serotonin reuptake inhibitors (SSRIs), which are widely used but have side effects such as dizziness, gastrointestinal discomfort and sexual dysfunction, and have a high relapse rate after discontinuation of medication. Psychological intervention is limited by resource accessibility and individual acceptance, and non-drug methods such as mindfulness training lack the ability to immediately relieve acute anxiety.

[0004] Aging is a complex process. Currently, the single mechanism of action of a single compound cannot really achieve anti-aging results.

[0005] There is still an urgent need in clinical practice to improve sleep, prevent and treat anxiety, and delay aging. Summary of the invention

[0006] In one aspect of the present invention, a composition for improving sleep, preventing and treating anxiety, and delaying aging is provided, wherein the composition comprises the following raw materials in parts by weight: 10-90 parts by weight of lily, 20-90 parts by weight of lemon balm, 20-90 parts by weight of liquorice, 20-95 parts by weight of mulberry, 20-90 parts by weight of tuckahoe, 10-85 parts by weight of spiny jujube seeds, 15-90 parts by weight of sea buckthorn, 20-95 parts by weight of lotus seed core, 20-92 parts by weight of roxburghii, 20-90 parts by weight of oxyphylla, 20-90 parts by weight of valerian root, 10-90 parts by weight of Acanthopanax senticosus, 5-95 parts by weight of red rose, 5-95 parts by weight of light bamboo leaf , 5-95 weight parts of snow lotus, 20-90 weight parts of gastrodia elata, 15-100 weight parts of passion flower, 20-95 weight parts of ergothioneine, 5-95 weight parts of dihydroquercetin, 25-150 weight parts of gamma-aminobutyric acid, 10-90 weight parts of casein peptides, 25-100 weight parts of royal jelly freeze-dried powder, 5-95 weight parts of pea peptides, 5-95 weight parts of tea theanine, 5-95 weight parts of fish collagen peptides and 5-95 weight parts of Haematococcus pluvialis powder.

[0007] In some embodiments of the present invention, the composition is composed of the following raw materials in parts by weight: 10-90 parts by weight of lily, 20-90 parts by weight of lemon balm, 20-90 parts by weight of liquorice, 20-95 parts by weight of mulberry, 20-90 parts by weight of tuckahoe, 10-85 parts by weight of spiny jujube seeds, 15-90 parts by weight of sea buckthorn, 20-95 parts by weight of lotus seed core, 20-92 parts by weight of roxburghii, 20-90 parts by weight of oxyphylla, 20-90 parts by weight of valerian root, 10-90 parts by weight of Acanthopanax senticosus, 5-95 parts by weight of red rose, 5-95 parts by weight of light bamboo leaf , 5-95 weight parts of snow lotus, 20-90 weight parts of gastrodia elata, 15-100 weight parts of passion flower, 20-95 weight parts of ergothioneine, 5-95 weight parts of dihydroquercetin, 25-150 weight parts of gamma-aminobutyric acid, 10-90 weight parts of casein peptides, 25-100 weight parts of royal jelly freeze-dried powder, 5-95 weight parts of pea peptides, 5-95 weight parts of tea theanine, 5-95 weight parts of fish collagen peptides and 5-95 weight parts of Haematococcus pluvialis powder.

[0008] In some embodiments of the present invention, the composition comprises or consists of the following raw materials in parts by weight: 40-60 parts by weight of lily, 40-60 parts by weight of lemon balm, 50-70 parts by weight of liquorice, 30-50 parts by weight of mulberry, 30-50 parts by weight of Poria, 50-70 parts by weight of spiny jujube seeds, 40-60 parts by weight of sea buckthorn, 20-40 parts by weight of lotus seed core, 60-80 parts by weight of roxburghii, 40-60 parts by weight of oxyphylla, 20-40 parts by weight of valerian root, 60-80 parts by weight of Acanthopanax senticosus, 50-70 parts by weight of red rose, 55-75 parts by weight of light bamboo leaves weight parts, 60-80 weight parts of snow lotus, 50-70 weight parts of gastrodia elata, 40-60 weight parts of passion flower, 15-35 weight parts of ergothioneine, 5-15 weight parts of dihydroquercetin, 20-40 weight parts of γ-aminobutyric acid, 10-30 weight parts of casein peptides, 20-40 weight parts of royal jelly freeze-dried powder, 5-15 weight parts of pea peptides, 5-15 weight parts of tea theanine, 5-15 weight parts of fish collagen peptides and 5-15 weight parts of Haematococcus pluvialis powder.

[0009] In some embodiments of the present invention, the composition is composed of the following raw materials in parts by weight: 50 parts by weight of lily, 50 parts by weight of lemon balm, 60 parts by weight of licorice, 40 parts by weight of mulberry, 40 parts by weight of Poria, 60 parts by weight of Ziziphus jujuba seeds, 50 parts by weight of seabuckthorn, 30 parts by weight of lotus seed core, 70 parts by weight of roxburghii, 50 parts by weight of Alpinia oxyphylla, 30 parts by weight of valerian root, 70 parts by weight of Acanthopanax senticosus, 60 parts by weight of red rose, 65 parts by weight of Leptospermum officinale, 70 parts by weight of Saussurea involucrata, 60 parts by weight of Gastrodia elata, 50 parts by weight of Passiflora incarnata, 25 parts by weight of ergothioneine, 10 parts by weight of dihydroquercetin, 30 parts by weight of γ-aminobutyric acid, 20 parts by weight of casein peptide, 30 parts by weight of freeze-dried royal jelly powder, 10 parts by weight of pea peptide, 10 parts by weight of tea theanine, 10 parts by weight of fish collagen peptide and 10 parts by weight of Haematococcus pluvialis powder.

[0010] In some embodiments of the present invention, a composition is provided, the composition consisting of the following raw materials in parts by weight: 50 parts by weight of lily, 50 parts by weight of lemon balm, 60 parts by weight of licorice, 40 parts by weight of mulberry, 40 parts by weight of Poria, 60 parts by weight of Ziziphus jujuba seeds, 50 parts by weight of seabuckthorn, 30 parts by weight of lotus seed core, 70 parts by weight of roxburghii, 50 parts by weight of Alpinia oxyphylla, 30 parts by weight of valerian root, 70 parts by weight of Acanthopanax senticosus, 60 parts by weight of red rose, 65 parts by weight of Leptospermum officinale, 70 parts by weight of Saussurea involucrata, 60 parts by weight of Gastrodia elata, 50 parts by weight of Passiflora incarnata, 25 parts by weight of ergothioneine, 10 parts by weight of dihydroquercetin, 30 parts by weight of γ-aminobutyric acid, 20 parts by weight of casein peptide, 30 parts by weight of freeze-dried royal jelly powder, 10 parts by weight of pea peptide, 10 parts by weight of tea theanine, 10 parts by weight of fish collagen peptide and 10 parts by weight of Haematococcus pluvialis powder.

[0011] In some embodiments of the present invention, the composition is prepared by: Take 50 parts by weight of lily, 50 parts by weight of lemon balm, 60 parts by weight of liquorice, 40 parts by weight of mulberry, 40 parts by weight of Poria, 60 parts by weight of spiny jujube seeds, 50 parts by weight of sea buckthorn, 30 parts by weight of lotus seed core, 70 parts by weight of roxburghii, 50 parts by weight of oxyphylla, 30 parts by weight of valerian root, 70 parts by weight of Acanthopanax senticosus, 60 parts by weight of red rose, 65 parts by weight of light bamboo leaves, 70 parts by weight of snow lotus, 60 parts by weight of gastrodia, 50 parts by weight of passionflower, respectively; washed with water, air-dried at room temperature, and crushed to an average particle size of 350 microns; mixed; then added 25 parts by weight of ergothioneine, 10 parts by weight of dihydroquercetin, 30 parts by weight of γ-aminobutyric acid, 20 parts by weight of casein peptide, 30 parts by weight of royal jelly freeze-dried powder, 10 parts by weight of pea peptide, 10 parts by weight of tea theanine, 10 parts by weight of fish collagen peptide, and 10 parts by weight of Haematococcus pluvialis powder; mixed again to obtain.

[0012] In some embodiments of the present invention, the lily is the dried fleshy scale leaf of Lilium serrata. In some embodiments of the present invention, the lemon balm is the dried whole herb. In some embodiments of the present invention, the licorice is the dried root. In some embodiments of the present invention, the mulberry is the dried fruit of black mulberry. In some embodiments of the present invention, the Poria is the dried sclerotium. In some embodiments of the present invention, the spiny jujube kernel is the dried seed of spiny jujube. In some embodiments of the present invention, the seabuckthorn is the dried fruit. In some embodiments of the present invention, the lotus seed heart is the dried young leaves and radicles in the mature seeds of lotus. In some embodiments of the present invention, the roxburghii is the dried fruit. In some embodiments of the present invention, the Alpinia oxyphylla is the dried fruit. In some embodiments of the present invention, the valerian root is the dried root and rhizome. In some embodiments of the present invention, the Acanthopanax senticosus is the dried root bark. In some embodiments of the present invention, the red rose is the dried flower bud. In some embodiments of the present invention, the light bamboo leaf is the dried leaf. In some embodiments of the present invention, the snow lotus is the dried whole herb. In some embodiments of the present invention, the Gastrodia elata is a dried tuber. In some embodiments of the present invention, the Passiflora incarnata is a dried whole herb. In some embodiments of the present invention, the ergothioneine is a commercial product of Shenzhen Zhongke Xinyang Biotechnology. In some embodiments of the present invention, the casein peptide is a commercial product of Sichuan Peptide Hui Biotechnology. In some embodiments of the present invention, the royal jelly freeze-dried powder is a commercial product of Shaanxi Panier Biotechnology. In some embodiments of the present invention, the pea peptide is a commercial product of Shaanxi Panier Biotechnology. In some embodiments of the present invention, the fish collagen peptide is a commercial product of Nanjing Songguan Biotechnology. In some embodiments of the present invention, the Haematococcus pluvialis powder is a commercial product of ZOLANBIO.

[0013] In some embodiments of the present invention, the composition is composition 1, composition 2, or composition 3 of Example 1. In some embodiments of the present invention, the composition is composition 3 of Example 1.

[0014] In some embodiments of the present invention, the preparation method of the composition is as described in Example 1. In some embodiments of the present invention, the preparation method of the composition is as described in the preparation method of composition 3 in Example 1.

[0015] In one aspect of the present invention, a pharmaceutical preparation for improving sleep, preventing and treating anxiety, and delaying aging is provided, characterized in that the pharmaceutical preparation comprises: a composition as described in the present invention, and a pharmaceutically acceptable carrier.

[0016] In some embodiments of the present invention, the pharmaceutical preparation is an oral preparation.

[0017] In some embodiments of the present invention, the pharmaceutical preparation is a granule, a tablet, a capsule, an granule, an oral solution, a dropping pill, a micropill or an injection.

[0018] In some embodiments of the present invention, the pharmaceutical preparation is an oral capsule preparation. In some embodiments of the present invention, the pharmaceutical preparation is an oral hard capsule.

[0019] In some embodiments of the present invention, the preparation method of the pharmaceutical preparation is as described in Example 5.

[0020] In one aspect of the present invention, a method for preparing a pharmaceutical preparation for improving sleep, preventing and treating anxiety, and delaying aging is provided, wherein the method for preparing the pharmaceutical preparation is: The composition according to any one of the embodiments of the present invention is mixed, sterilized by irradiation, granulated, dried, and granulated to obtain the composition granules.

[0021] In some embodiments of the present invention, the pharmaceutical preparation is an oral dosage form. In some embodiments of the present invention, the pharmaceutical preparation is a granule, tablet, capsule, granule, oral liquid, drop pill, micropill or injection.

[0022] In some embodiments of the present invention, the pharmaceutical preparation is a hard capsule. In some embodiments of the present invention, the preparation method of the pharmaceutical preparation is as described in Example 5.

[0023] In some embodiments of the present invention, the preparation method of the pharmaceutical preparation is as follows: 50 parts by weight of lily, 50 parts by weight of lemon balm, 60 parts by weight of licorice, 40 parts by weight of mulberry, 40 parts by weight of Poria, 60 parts by weight of spina jujuba seeds, 50 parts by weight of sea buckthorn, 30 parts by weight of lotus seed core, 70 parts by weight of roxburghii, 50 parts by weight of alpinia oxyphylla, 30 parts by weight of valerian root, 70 parts by weight of Acanthopanax senticosus, 60 parts by weight of red rose, 65 parts by weight of light bamboo leaves, 70 parts by weight of snow lotus, and 60 parts by weight of Gastrodia elata. , 50 weight parts of passion fruit; wash them with water respectively, air-dry at room temperature, and grind them to an average particle size of 350 microns; mix them; then add 25 weight parts of ergothioneine, 10 weight parts of dihydroquercetin, 30 weight parts of γ-aminobutyric acid, 20 weight parts of casein peptide, 30 weight parts of royal jelly freeze-dried powder, 10 weight parts of pea peptide, 10 weight parts of tea theanine, 10 weight parts of fish collagen peptide, and 10 weight parts of Haematococcus pluvialis powder, and mix them again; sterilize with cobalt-60 radiation, with an irradiation dose of 3 KGy; add 4% by volume of 70% ethanol to the sterilized mixture, make a soft material, and then granulate it through a 10-16 mesh sieve; dry it at 60°C for 3h; granulate it to obtain granules.

[0024] In some embodiments of the present invention, 250 mg of the granules of the present invention are loaded into a hard capsule shell to obtain a hard capsule.

[0025] In some embodiments of the present invention, the granulation method is to add 3%-6% by weight of 65%-75% ethanol to the sterilized mixture to make a soft material, and then granulate it through a 10-16 mesh sieve.

[0026] In some embodiments of the present invention, the granulation method is to add 4% by weight of 70% ethanol in a volume fraction to the sterilized mixture to make a soft material, and then granulate it through a 10-16 mesh sieve.

[0027] In some embodiments of the present invention, the drying temperature is 50-70°C and the drying time is 2-4 hours. In some embodiments of the present invention, the drying temperature is 60°C and the drying time is 3 hours.

[0028] In some embodiments of the present invention, the sterilization is irradiation sterilization, and the environment of the irradiation sterilization is: cobalt-60 radiation sterilization, and the irradiation dose is greater than 0 KGy and less than or equal to 6 KGy. In some embodiments of the present invention, the sterilization is irradiation sterilization, and the environment of the irradiation sterilization is: cobalt-60 radiation sterilization, and the irradiation dose is 3 KGy.

[0029] In another aspect of the present invention, there is provided use of the composition of the present invention in the preparation of a medicament for improving sleep, preventing and treating anxiety, and delaying aging.

[0030] In another aspect of the present invention, there is provided a use of the composition of the present invention in the preparation of a medicament for improving sleep. In another aspect of the present invention, there is provided a use of the composition of the present invention in the preparation of a medicament for prolonging sleep time.

[0031] In another aspect of the present invention, there is provided a use of the composition of the present invention in the preparation of a medicament for preventing and treating anxiety. In another aspect of the present invention, there is provided a use of the composition of the present invention in the preparation of a medicament for preventing anxiety. In another aspect of the present invention, there is provided a use of the composition of the present invention in the preparation of a medicament for treating anxiety.

[0032] In another aspect of the present invention, there is provided a use of the composition of the present invention in the preparation of a drug for delaying aging. In another aspect of the present invention, there is provided a use of the composition of the present invention in the preparation of a drug for anti-aging.

[0033] Beneficial effects of the technical solution of the present invention: The composition of the present invention can significantly prolong the sleeping time of the model animals, indicating that it can be used to improve sleep; The composition of the present invention has certain antianxiety activity; The composition of the present invention has certain anti-aging activity; The preparation method of the composition of the present invention is simple, rapid and low-cost; The composition of the present invention adopts reasonable proportions of various components, is convenient for patients to take and carry, and has good effects; in addition, the preparation method of the composition is simple, the performance is stable and reliable, the production efficiency is high, the production cost is low, and it has broad application prospects. DETAILED DESCRIPTION

[0034] The raw materials used in the following examples are: lily (dried fleshy scale leaves of lily of the valley), lemon balm (dried whole herb), licorice (dried root), mulberry (dried fruit of black mulberry), Poria (dried sclerotium), spiny jujube kernel (dried seeds of spiny jujube), sea buckthorn (dried fruit), Lotus seed core (dried young leaves and radicles of mature lotus seeds), Rosa roxburghii (dried fruit), Alpinia oxyphylla (dried fruit), valerian root (dried root and rhizome), Acanthopanax senticosus (dried root bark), red rose (dried flower buds), Lophatherum gracile (dried leaves), Saussurea involucrata (dried whole herb), Gastrodia elata (dried tuber), Passiflora incarnata (dried whole herb), ergothioneine (Shenzhen Zhongke Xinyang Biotechnology), dihydroquercetin, γ-aminobutyric acid, casein peptide (Sichuan Peptidehui Biotechnology), royal jelly freeze-dried powder (Shaanxi Panier Biotechnology), pea peptide (Shaanxi Panier Biotechnology), tea theanine, fish collagen peptide (Nanjing Songguan Biotechnology), Haematococcus pluvialis powder (ZOLANBIO).

[0035] Example 1. Preparation of the composition Take 50 parts by weight of lily, 50 parts by weight of lemon balm, 60 parts by weight of licorice, 40 parts by weight of mulberry, 40 parts by weight of Poria, 60 parts by weight of Ziziphus jujuba seeds, 50 parts by weight of seabuckthorn, 30 parts by weight of lotus seed core, 70 parts by weight of Rosa roxburghii, 50 parts by weight of Alpinia oxyphylla seeds, and 30 parts by weight of valerian root; wash them respectively with water, air-dry them at room temperature, and grind them to an average particle size of 350 μm; mix them evenly to obtain a solid powder composition 1 (AMX-SLE-01).

[0036] Take 70 parts by weight of Acanthopanax senticosus, 60 parts by weight of Red Rose, 65 parts by weight of Lophatherum gracile, 70 parts by weight of Saussurea involucrata, 60 parts by weight of Gastrodia elata, and 50 parts by weight of Passiflora incarnata; wash them respectively with water, air-dry them at room temperature, and grind them to an average particle size of 350 μm; mix them well; then add 25 parts by weight of ergothioneine, 10 parts by weight of dihydroquercetin, 30 parts by weight of γ-aminobutyric acid, 20 parts by weight of casein peptide, 30 parts by weight of freeze-dried royal jelly powder, 10 parts by weight of pea peptide, 10 parts by weight of tea theanine, 10 parts by weight of fish collagen peptide, and 10 parts by weight of Haematococcus pluvialis powder; mix them well again to obtain a solid powder composition 2 (AMX-SLE-02).

[0037] Take 50 parts by weight of lily, 50 parts by weight of lemon balm, 60 parts by weight of liquorice, 40 parts by weight of mulberry, 40 parts by weight of Poria, 60 parts by weight of spina jujuba seeds, 50 parts by weight of sea buckthorn, 30 parts by weight of lotus seed core, 70 parts by weight of roxburghii, 50 parts by weight of alpinia oxyphylla, 30 parts by weight of valerian root, 70 parts by weight of Acanthopanax senticosus, 60 parts by weight of red rose, 65 parts by weight of light bamboo leaves, 70 parts by weight of snow lotus, 60 parts by weight of gastrodia elata, and 50 parts by weight of passion flower; wash them separately with water, Air-dry at room temperature and crush to an average particle size of 350 μm; mix; then add 25 parts by weight of ergothioneine, 10 parts by weight of dihydroquercetin, 30 parts by weight of γ-aminobutyric acid, 20 parts by weight of casein peptide, 30 parts by weight of royal jelly freeze-dried powder, 10 parts by weight of pea peptide, 10 parts by weight of tea theanine, 10 parts by weight of fish collagen peptide, and 10 parts by weight of Haematococcus pluvialis powder; mix again to obtain a solid powder composition 3 (AMX-SLE-03).

[0038] The Chinese herbal enzyme beverage is prepared according to the method described in the patent specification with publication number CN109730221A: the fruits are washed, screened, peeled and cored, the Chinese medicinal materials are washed, the floating water is blown off and the wall is broken, and the following components and weights are weighed respectively: 10g of kiwi fruit, 10g of polygala, 10g of red fruit, 10g of sea buckthorn fruit, 10g of mulberry, 10g of pitaya, 10g of green apple, 10g of lily, 10g of green jujube, 10g of gardenia, 10g of pineapple, 10g of longan, 10g of lemon, 10g of grape, 10g of pomegranate, 10g of black lotus, 10g of papaya, 10g of banana, 10g of salvia miltiorrhiza 0g, 10g of Gastrodia elata, 20g of Schisandra chinensis, 20g of Longan pulp, 20g of Poria cocos, 20g of Platycladus orientalis seeds, 20g of Ziziphus jujuba seeds, 20g of Panax notoginseng flowers, 20g of Albizzia julibrissin, 20g of Polygonatum multiflorum, 20g of Cordyceps sinensis, and 20g of Polygonatum sibiricum; then place the above fruits and Chinese medicinal materials in a fermentation vessel, and add sugar, honey water and primer, wherein fruit: sugar: honey: water = 3:1:0.5:10, primer: water = 1:15, Chinese medicinal materials: sugar = 10:1, wait for fermentation, and use light-proof anaerobic constant temperature conditions for a fermentation process of up to 300 days to finally obtain a Chinese herbal enzyme beverage. Then freeze-dry at -20℃ to obtain a solid powder composition 4.

[0039] Example 2. Composition prolongs the sleep time of model animals Male ICR mice weighing 22.3 g to 23.1 g were randomly divided into groups, with 10 mice in each group.

[0040] The mice were fed normally for 30 days (days 1 to 30), and were gavaged daily with 0.3 mL of an aqueous suspension of the composition described in Example 1 (0.2 mg composition / g body weight, obtained by stirring the composition in water at 300 rpm for 5 minutes). A control group 1 and a control group 2 were also set up, both of which were fed normally and were gavaged daily with 0.3 mL of normal saline.

[0041] Starting from the 31st day, each experimental group (each composition group) and control group 1 were intraperitoneally injected with parachlorophenylalanine PCPA (320 mg / kg per day) for 4 consecutive days to induce insomnia in mice; control group 2 was replaced with an approximately equal volume of normal saline. On the 4th day, each group was intraperitoneally injected with PCPA or normal saline for 1.5 hours, and then intraperitoneally injected with a threshold dose of sodium pentobarbital. The disappearance of the righting reflex was taken as the time of falling asleep, and the recovery of the righting reflex was taken as the time of waking up. The duration of sleep of the mice was recorded. The average value of the mice in each group was taken.

[0042] The experimental results are shown in Table 1. The model was successfully established. Composition 3 can reverse the insomnia model induced by PCPA and significantly increase the total sleep time of mice compared with other groups, with statistically significant differences (P < 0.01). The sleep time of mice given composition 3 was much longer than that of composition 1 and composition 2 (P < 0.01), and was also much better than composition 4 and control group 1.

[0043] Table 1. Sleeping time of animals Example 3. Anti-anxiety function test of the composition The elevated plus maze test was performed according to the reference method. The specific steps are as follows: Healthy 5-week-old male ICR mice were randomly divided into groups, with 10 mice in each group. They were fed normally for 40 days (from day 1 to day 40), and were gavaged daily with 0.3 mL of an aqueous suspension of the composition described in Example 1 (0.2 mg composition / g body weight, obtained by stirring the composition in water at 300 rpm for 5 minutes); a control group 1 and a control group 2 were set up, both of which were fed normally; control group 1 was gavaged with 0.3 mL of normal saline daily from day 1 to day 40; control group 2 was gavaged with 0.3 mL of normal saline daily from day 1 to day 39, and diazepam (dissolved in 0.9% NaCl containing 1% DMSO) 3 mg / kg was gavaged on day 40.

[0044] 40 minutes after gavage on the 40th day, the plus maze test was started. The test apparatus has four arms, each arm is about 25 by 5 cm, and extends outward from a 5 by 5 cm central cross platform. There are two opposite arms surrounded by 20 cm opaque walls, which serve as two closed arms. The plus maze is 50 cm above the ground. During the experiment, the mouse is placed on the central cross platform with its head facing the open arm, and then the mouse's stay time in the open arm and the closed arm is recorded in the next 4 minutes.

[0045] The results are shown in Table 2, and the average value of mice in each group was taken. The mice in control group 2 stayed in the open arm much longer than those in control group 1 (P<0.01), and the model was successful. The mice given composition 3 stayed in the open arm much longer than those in control group 1 (P<0.01) and composition 4 (P<0.01), with statistically significant differences, and even better than control group 2. This shows that composition 3 has an anti-anxiety effect, while composition 4 has no anxiolytic effect.

[0046] Table 2. Plus maze test Example 4. Anti-aging function test of the composition Human WI-38 fibroblasts were cultured in DMEM medium containing 10% fetal bovine serum, and low concentration of hydrogen peroxide was added for 20 hours to induce cell aging caused by oxidative stress. The aqueous suspension of composition 3 prepared as described above (the negative control group was replaced with an equal amount of water) was added to the cells, gently shaken, and maintained for 30 hours. The activity of β-galactosidase in the cells was measured using a β-galactosidase staining kit, and the cells were observed under a microscope. The results showed that the blue-stained cell ratio of composition 3 was numerically lower than that of the negative control group (38% vs. 46%), indicating that it has certain anti-aging activity.

[0047] Example 5. Preparation Preparation Example 1: Take 50 parts by weight of lily, 50 parts by weight of lemon balm, 60 parts by weight of liquorice, 40 parts by weight of mulberry, 40 parts by weight of Poria, 60 parts by weight of Ziziphus jujuba seeds, 50 parts by weight of sea buckthorn, 30 parts by weight of lotus seed core, 70 parts by weight of roxburghii, 50 parts by weight of Alpinia oxyphylla, 30 parts by weight of valerian root, 70 parts by weight of Acanthopanax senticosus, 60 parts by weight of red rose, 65 parts by weight of light bamboo leaves, 70 parts by weight of snow lotus, 60 parts by weight of Gastrodia elata, and 50 parts by weight of passionflower; wash them with water, air-dry them at room temperature, and grind them into powder. The mixture is crushed to an average particle size of 350 μm; mixed; then 25 parts by weight of ergothioneine, 10 parts by weight of dihydroquercetin, 30 parts by weight of γ-aminobutyric acid, 20 parts by weight of casein peptide, 30 parts by weight of royal jelly freeze-dried powder, 10 parts by weight of pea peptide, 10 parts by weight of tea theanine, 10 parts by weight of fish collagen peptide, and 10 parts by weight of Haematococcus pluvialis powder are added, and mixed again (to obtain a solid powder composition 3, AMX-SLE-03); sterilized, and an oral dosage form is prepared by an oral dosage form process.

[0048] Preparation Example 2: Take 50 parts by weight of lily, 50 parts by weight of lemon balm, 60 parts by weight of licorice, 40 parts by weight of mulberry, 40 parts by weight of Poria, 60 parts by weight of Ziziphus jujuba seeds, 50 parts by weight of sea buckthorn, 30 parts by weight of lotus seed core, 70 parts by weight of roxburghii, 50 parts by weight of Alpinia oxyphylla, 30 parts by weight of valerian root, 70 parts by weight of Acanthopanax senticosus, 60 parts by weight of red rose, 65 parts by weight of light bamboo leaves, 70 parts by weight of snow lotus, 60 parts by weight of Gastrodia elata, and 50 parts by weight of passionflower; respectively, add water and The method comprises the following steps: washing, air-drying at room temperature, and crushing the mixture to an average particle size of 350 μm; mixing; then adding 25 parts by weight of ergothioneine, 10 parts by weight of dihydroquercetin, 30 parts by weight of γ-aminobutyric acid, 20 parts by weight of casein peptide, 30 parts by weight of royal jelly freeze-dried powder, 10 parts by weight of pea peptide, 10 parts by weight of tea theanine, 10 parts by weight of fish collagen peptide, and 10 parts by weight of Haematococcus pluvialis powder, and mixing the mixture again; sterilizing by irradiation, granulating, drying, and granulating the mixture to obtain granules.

[0049] Preparation Example 3: Take 50 parts by weight of lily, 50 parts by weight of lemon balm, 60 parts by weight of licorice, 40 parts by weight of mulberry, 40 parts by weight of Poria, 60 parts by weight of Ziziphus jujuba seeds, 50 parts by weight of seabuckthorn, 30 parts by weight of lotus seed core, 70 parts by weight of roxburghii, 50 parts by weight of Alpinia oxyphylla, 30 parts by weight of valerian root, 70 parts by weight of Acanthopanax senticosus, 60 parts by weight of red rose, 65 parts by weight of Lophatherum gracile, 70 parts by weight of Saussurea involucrata, 60 parts by weight of Gastrodia elata, and 50 parts by weight of Passionflower; The mixture was washed with water, air-dried at room temperature, and crushed to an average particle size of 350 μm; mixed; then 25 parts by weight of ergothioneine, 10 parts by weight of dihydroquercetin, 30 parts by weight of γ-aminobutyric acid, 20 parts by weight of casein peptide, 30 parts by weight of royal jelly freeze-dried powder, 10 parts by weight of pea peptide, 10 parts by weight of tea theanine, 10 parts by weight of fish collagen peptide, and 10 parts by weight of Haematococcus pluvialis powder were added, and mixed again; sterilized by cobalt-60 radiation, with an irradiation dose of 3 KGy; 4% by weight of 70% ethanol was added to the sterilized mixture, and the mixture was made into a soft material and then granulated through a 10-16 mesh sieve; dried at 60°C for 3h; granulated to obtain granules.

[0050] Preparation Example 4: 250 mg of the granules prepared as described in Preparation Example 3 were loaded into hard capsule shells to obtain hard capsules.

[0051] The above is only a preferred embodiment of the present invention, and does not limit the present invention in other forms. Any technician familiar with the profession may use the above disclosed technical content to change or modify it into an equivalent embodiment with equivalent changes. However, any simple modification, equivalent change and modification made to the above embodiment according to the technical essence of the present invention without departing from the technical solution of the present invention still belongs to the protection scope of the technical solution of the present invention.

Claims

1. A composition for improving sleep, preventing and treating anxiety, and delaying aging, characterized in that: The composition is composed of the following raw materials in parts by weight: 10-90 parts by weight of lily, 20-90 parts by weight of lemon balm, 20-90 parts by weight of liquorice, 20-95 parts by weight of mulberry, 20-90 parts by weight of tuckahoe, 10-85 parts by weight of spiny jujube seeds, 15-90 parts by weight of sea buckthorn, 20-95 parts by weight of lotus seed core, 20-92 parts by weight of roxburghii, 20-90 parts by weight of oxyphylla, 20-90 parts by weight of valerian root, 10-90 parts by weight of Acanthopanax senticosus, 5-95 parts by weight of red rose, 5-95 parts by weight of light bamboo leaf , 5-95 weight parts of snow lotus, 20-90 weight parts of gastrodia elata, 15-100 weight parts of passion flower, 20-95 weight parts of ergothioneine, 5-95 weight parts of dihydroquercetin, 25-150 weight parts of gamma-aminobutyric acid, 10-90 weight parts of casein peptides, 25-100 weight parts of royal jelly freeze-dried powder, 5-95 weight parts of pea peptides, 5-95 weight parts of tea theanine, 5-95 weight parts of fish collagen peptides and 5-95 weight parts of Haematococcus pluvialis powder.

2. The composition according to claim 1, characterized in that The composition is composed of the following raw materials in parts by weight: 40-60 parts by weight of lily, 40-60 parts by weight of lemon balm, 50-70 parts by weight of liquorice, 30-50 parts by weight of mulberry, 30-50 parts by weight of Poria, 50-70 parts by weight of spiny jujube seeds, 40-60 parts by weight of sea buckthorn, 20-40 parts by weight of lotus seed core, 60-80 parts by weight of roxburghii, 40-60 parts by weight of oxyphylla, 20-40 parts by weight of valerian root, 60-80 parts by weight of Acanthopanax senticosus, 50-70 parts by weight of red rose, 55-75 parts by weight of light bamboo leaves weight parts, 60-80 weight parts of snow lotus, 50-70 weight parts of gastrodia elata, 40-60 weight parts of passion flower, 15-35 weight parts of ergothioneine, 5-15 weight parts of dihydroquercetin, 20-40 weight parts of γ-aminobutyric acid, 10-30 weight parts of casein peptides, 20-40 weight parts of royal jelly freeze-dried powder, 5-15 weight parts of pea peptides, 5-15 weight parts of tea theanine, 5-15 weight parts of fish collagen peptides and 5-15 weight parts of Haematococcus pluvialis powder.

3. The composition according to claim 1, characterized in that The compound is composed of the following raw materials in parts by weight: 50 parts by weight of lily, 50 parts by weight of lemon balm, 60 parts by weight of licorice, 40 parts by weight of mulberry, 40 parts by weight of Poria, 60 parts by weight of Ziziphus jujuba seeds, 50 parts by weight of seabuckthorn, 30 parts by weight of lotus seed core, 70 parts by weight of roxburghii, 50 parts by weight of Alpinia oxyphylla, 30 parts by weight of valerian root, 70 parts by weight of Acanthopanax senticosus, 60 parts by weight of red rose, 65 parts by weight of Leptospermum officinale, 70 parts by weight of Saussurea involucrata, 60 parts by weight of Gastrodia elata, 50 parts by weight of Passiflora incarnata, 25 parts by weight of ergothioneine, 10 parts by weight of dihydroquercetin, 30 parts by weight of γ-aminobutyric acid, 20 parts by weight of casein peptide, 30 parts by weight of freeze-dried royal jelly powder, 10 parts by weight of pea peptide, 10 parts by weight of tea theanine, 10 parts by weight of fish collagen peptide and 10 parts by weight of Haematococcus pluvialis powder.

4. The composition according to claim 1, characterized in that The preparation method of the composition is: Take 50 parts by weight of lily, 50 parts by weight of lemon balm, 60 parts by weight of liquorice, 40 parts by weight of mulberry, 40 parts by weight of Poria, 60 parts by weight of spiny jujube seeds, 50 parts by weight of sea buckthorn, 30 parts by weight of lotus seed core, 70 parts by weight of roxburghii, 50 parts by weight of oxyphylla, 30 parts by weight of valerian root, 70 parts by weight of Acanthopanax senticosus, 60 parts by weight of red rose, 65 parts by weight of light bamboo leaves, 70 parts by weight of snow lotus, 60 parts by weight of gastrodia, 50 parts by weight of passionflower, respectively; washed with water, air-dried at room temperature, and crushed to an average particle size of 350 microns; mixed; then added 25 parts by weight of ergothioneine, 10 parts by weight of dihydroquercetin, 30 parts by weight of γ-aminobutyric acid, 20 parts by weight of casein peptide, 30 parts by weight of royal jelly freeze-dried powder, 10 parts by weight of pea peptide, 10 parts by weight of tea theanine, 10 parts by weight of fish collagen peptide, and 10 parts by weight of Haematococcus pluvialis powder; mixed again to obtain.

5. A pharmaceutical preparation for improving sleep, preventing and treating anxiety, and delaying aging, characterized in that: The pharmaceutical preparation comprises: the composition according to any one of claims 1 to 4, and a pharmaceutically acceptable carrier.

6. The pharmaceutical preparation according to claim 5, characterized in that The pharmaceutical preparation is a granule, tablet, capsule, granule, oral liquid, dripping pill, micropill or injection.

7. A method for preparing a pharmaceutical preparation for improving sleep, preventing and treating anxiety, and delaying aging, characterized in that: The preparation method of the pharmaceutical preparation is: The composition according to any one of claims 1 to 4 is mixed, sterilized by irradiation, granulated, dried, and granulated to obtain the composition granules.

8. The preparation method according to claim 7, characterized in that: The granulation method comprises the following steps: adding 3% to 6% by weight of ethanol with a volume fraction of 65% to 75% to the sterilized mixture, making a soft material, and then granulating the mixture through a 10-16 mesh sieve.

9. The preparation method according to claim 7, characterized in that: The drying temperature is 50-70° C. and the drying time is 2-4 hours.

10. The preparation method according to claim 7, characterized in that: The sterilization is radiation sterilization, and the environment of the radiation sterilization is: cobalt-60 radiation sterilization, and the radiation dose is greater than 0 KGy and less than or equal to 6 KGy.

Images