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

Abstract

The present invention discloses a composition for improving sleep, preventing and treating anxiety, delaying aging and its preparation method. The composition includes lily, lemon balm, liquorice, mulberry, Poria, spinach seed, sea buckthorn, lotus seed core, roxburghii, alpinia oxyphylla, valerian root, acanthopanax senticosus, red rose, light bamboo leaf, snow lotus, 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 of the present invention rationally proportions each component, and patient takes and is easy to carry, and is effective. In addition, the preparation method process of the composition is simple, stable and reliable in performance, high in production efficiency, low in production cost, and has broad application prospects.

Description

Technical Field

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

[0002] Mainstream sleep improvement strategies rely on sedatives (such as benzodiazepines). While these medications can promote sleep in the short term, long-term use can lead to drug tolerance, cognitive impairment, and withdrawal symptoms. Non-pharmacological therapies, such as cognitive behavioral therapy, require professional guidance and are long-term, leading to low patient compliance. Natural supplements (such as melatonin) have limited efficacy in treating chronic insomnia, and high doses may disrupt endocrine balance.

[0003] Anti-anxiety drugs mainly include selective serotonin reuptake inhibitors (SSRIs). Although they are widely used, they have side effects such as dizziness, gastrointestinal discomfort and sexual dysfunction, and the relapse rate after discontinuation is high. 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 compound has a single mechanism of action and cannot truly achieve anti-aging results.

[0005] There is still an urgent clinical need 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:

[0007] 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 poria, 10-85 parts by weight of spinach 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 alpinia 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 bamboo leaves The invention relates to a novel composition comprising the following ingredients: 1, a first portion of a safflower oil, a second portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil

[0008] In some embodiments of the present invention, the composition is composed of the following raw materials in parts by weight:

[0009] 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 poria, 10-85 parts by weight of spinach 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 alpinia 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 bamboo leaves The invention relates to a novel composition comprising the following ingredients: 1, a first portion of a safflower oil, a second portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil, a first portion of a safflower oil

[0010] In some embodiments of the present invention, the composition comprises or consists of the following raw materials in parts by weight:

[0011] 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 spinach 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 alpinia 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 gamma-aminobutyric acid, 10-30 weight parts of casein peptide, 20-40 weight parts of royal jelly freeze-dried powder, 5-15 weight parts of pea peptide, 5-15 weight parts of tea theanine, 5-15 weight parts of fish collagen peptide and 5-15 weight parts of Haematococcus pluvialis powder.

[0012] In some embodiments of the present invention, the composition is composed of the following raw materials in parts by weight:

[0013] 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 spinach seed, 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 bamboo leaf, 70 parts by weight of snow lotus, 60 parts by weight of gastrodia elata, 50 parts by weight of passionflower, 25 parts by weight of ergothioneine, 10 parts by weight of dihydroquercetin, 30 parts by weight of gamma-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.

[0014] In some embodiments of the present invention, a composition is provided, comprising the following raw materials in parts by weight:

[0015] 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 spinach seed, 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 bamboo leaf, 70 parts by weight of snow lotus, 60 parts by weight of gastrodia elata, 50 parts by weight of passionflower, 25 parts by weight of ergothioneine, 10 parts by weight of dihydroquercetin, 30 parts by weight of gamma-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.

[0016] In some embodiments of the present invention, the composition is prepared by:

[0017] Take 50 weight parts of lily, 50 weight parts of lemon balm, 60 weight parts of liquorice, 40 weight parts of mulberry, 40 weight parts of Poria, 60 weight parts of jujube seed, 50 weight parts of sea buckthorn, 30 weight parts of lotus seed core, 70 weight parts of roxburghii, 50 weight parts of yizhiren, 30 weight parts of valerian root, 70 weight parts of acanthopanax senticosus, 60 weight parts of red rose, 65 weight parts of light bamboo leaf, 70 weight parts of snow lotus, 60 weight parts of gastrodia, 50 weight parts of passionflower. respectively washed with water, air-dried at room temperature, and crushed 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.

[0018] In some embodiments of the present invention, the lily is the dried fleshy scale leaves of Lilium tenuifolium. 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 cocos is the dried sclerotium. In some embodiments of the present invention, the spinach seeds are the dried seeds of spinach. In some embodiments of the present invention, the sea buckthorn is the dried fruit. In some embodiments of the present invention, the lotus seed core is the dried young leaves and radicles of 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 leaves are the dried leaves. 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.

[0019] 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.

[0020] 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.

[0021] 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: the composition according to the present invention, and a pharmaceutically acceptable carrier.

[0022] In some embodiments of the present invention, the pharmaceutical formulation is an oral formulation.

[0023] In some embodiments of the present invention, the pharmaceutical preparation is a granule, tablet, capsule, granule, oral solution, dripping pill, micropill or injection.

[0024] 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.

[0025] In some embodiments of the present invention, the preparation method of the pharmaceutical preparation is as described in Example 5.

[0026] 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:

[0027] The composition according to any one of the present invention is mixed, sterilized by irradiation, granulated, dried, and sized to obtain the composition granules.

[0028] 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 solution, pill, pellet or injection.

[0029] In some embodiments of the present invention, the pharmaceutical preparation is a hard capsule.

[0030] In some embodiments of the present invention, the preparation method of the pharmaceutical preparation is as described in Example 5.

[0031] 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 liquorice, 40 parts by weight of mulberry, 40 parts by weight of Poria, 60 parts by weight of spinach seed, 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 leaf, 70 parts by weight of snow lotus, and 60 parts by weight of Gastrodia elata. , 50 parts by weight of passion fruit; respectively washed with water, air-dried at room temperature, and crushed to an average particle size of 350 μm; 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, and mixed again; sterilized by cobalt-60 radiation with an irradiation dose of 3 KGy; added 70% by volume ethanol at a volume fraction of 4% of the weight of the sterilized mixture, made into a soft material, and then granulated through a 10-16 mesh sieve; dried at 60°C for 3h; granulated to obtain granules.

[0032] 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.

[0033] 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.

[0034] In some embodiments of the present invention, the granulation method is to add 4% by weight of 70% ethanol to the sterilized mixture to make a soft material, and then granulate it through a 10-16 mesh sieve.

[0035] In some embodiments of the present invention, the drying temperature is 50-70° C., and the drying time is 2-4 h. In some embodiments of the present invention, the drying temperature is 60° C., and the drying time is 3 h.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] In another aspect, the present invention provides use of the composition of the present invention in preparing a medicament for preventing and treating anxiety. In another aspect, the present invention provides use of the composition of the present invention in preparing a medicament for preventing anxiety. In another aspect, the present invention provides use of the composition of the present invention in preparing a medicament for treating anxiety.

[0040] 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.

[0041] Beneficial effects of the technical solution of the present invention:

[0042] The composition of the present invention can significantly prolong the sleep time of model animals, indicating that it can be used to improve sleep;

[0043] The composition of the present invention has certain anxiolytic activity;

[0044] The composition of the present invention has certain anti-aging activity;

[0045] The preparation method of the composition of the present invention is simple, rapid and low-cost;

[0046] 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

[0047] 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), jujube kernel (dried seeds of jujube), sea buckthorn (dried fruit), Lotus seed core (dried young leaves and radicles from 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), Bamboo shoots (dried leaves), Snow Lotus (dried whole herb), Gastrodia elata (dried tuber), Passionflower (dried whole herb), Ergothioneine (Shenzhen Zhongke Xinyang Biotechnology), Dihydroquercetin, Gamma-aminobutyric acid, Casein peptide (Sichuan Peptide Hui Biotechnology), Freeze-dried royal jelly powder (Shaanxi Panier Biotechnology), Pea peptide (Shaanxi Panier Biotechnology), Tea theanine, Fish collagen peptide (Nanjing Songguan Biotechnology), Haematococcus pluvialis powder (ZOLANBIO).

[0048] Example 1. Preparation of the composition

[0049] 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 cocos, 60 parts by weight of spinach seed, 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, and 30 parts by weight of valerian root; wash them separately with water, air-dry them at room temperature, and grind them to an average particle size of 350 μm; and mix them evenly to obtain a solid powder composition 1 (AMX-SLE-01).

[0050] 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, and 50 parts by weight of Passiflora incarnata are taken; they are respectively washed with water, air-dried at room temperature, and crushed to an average particle size of 350 μm; and 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 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 are added; and the mixture is mixed again to obtain a solid powder composition 2 (AMX-SLE-02).

[0051] 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 jujube seed, 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 leaf, 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, The mixture was air-dried at room temperature and crushed to an average particle size of 350 μm; the mixture was mixed; 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 were then added; the mixture was mixed again to obtain a solid powder composition 3 (AMX-SLE-03).

[0052] The Chinese herbal enzyme beverage was prepared according to the method described in the patent specification with publication number CN109730221A: the fruits were washed, screened, peeled and cored, the Chinese medicinal materials were washed, the floating water was blown off and the wall was broken, and the following components and weights were weighed respectively: 10g of kiwi fruit, 10g of polygala, 10g of red fruit, 10g of sea buckthorn fruit, 10g of mulberry, 10g of dragon fruit, 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 Gastrodia elata, 20g Schisandra chinensis, 20g Longan meat, 20g Poria cocos, 20g Platycladus orientalis seeds, 20g Ziziphus jujuba seeds, 20g Panax notoginseng flower, 20g Albizia julibrissin bark, 20g Polygonatum multiflorum, 20g Cordyceps sinensis, 20g Polygonatum sibiricum; then place the above fruits and Chinese medicinal materials in a fermentation vessel, and add sugar, honey water and primer, wherein the ratio of fruit: sugar: honey: water is 3:1:0.5:10, primer: water is 1:15, and Chinese medicinal materials: sugar is 10:1, and fermentation is carried out under light-proof, anaerobic and constant temperature conditions for up to 300 days, finally obtaining a Chinese herbal enzyme beverage. Then freeze-drying at -20°C to obtain a solid powder composition 4.

[0053] Example 2. Composition prolongs sleep time in model animals

[0054] Male ICR mice weighing 22.3 g to 23.1 g were randomly divided into groups, with 10 mice in each group.

[0055] The mice were housed normally for 30 days (days 1 to 30) and gavaged daily with 0.3 mL of an aqueous suspension of the composition described in Example 1 (0.2 mg composition / g body weight, prepared by stirring the composition in water at 300 rpm for 5 minutes). Control groups 1 and 2 were also established, both housed normally and gavaged daily with 0.3 mL of normal saline.

[0056] Starting on day 31, each experimental group (each composition group) and control group 1 received continuous intraperitoneal injections of para-chlorophenylalanine (PCPA) (320 mg / kg daily) for four days to induce insomnia in mice; control group 2 received an approximately equal volume of saline instead. On day 4, 1.5 hours after the PCPA or saline injection, each group received a suprathreshold dose of sodium pentobarbital. The duration of sleep was measured, with the loss of the righting reflex defined as sleep onset and the return of the righting reflex defined as awakening. The average value of the mice within each group was used.

[0057] The experimental results, shown in Table 1, demonstrate successful modeling. Composition 3 reversed the PCPA-induced insomnia model and significantly increased the total sleep duration of mice compared to the other groups, with statistically significant differences (P < 0.01). Mice receiving Composition 3 slept significantly longer than those receiving Compositions 1 and 2 (P < 0.01), and also significantly better than those receiving Composition 4 and Control Group 1.

[0058] Table 1. Sleep time of animals

[0059]

[0060] Example 3. Anti-anxiety function test of the composition

[0061] The elevated plus maze test was performed according to the reference method. The specific steps are as follows:

[0062] Healthy 5-week-old male ICR mice were randomly divided into 10 groups. They were housed normally for 40 days (days 1 to 40) and gavaged daily with 0.3 mL of an aqueous suspension of the composition described in Example 1 (0.2 mg of the composition / g body weight, prepared by stirring the composition in water at 300 rpm for 5 minutes). Two control groups, 1 and 2, were housed normally. Control group 1 received 0.3 mL of normal saline daily by gavage from days 1 to 40; control group 2 received 0.3 mL of normal saline daily by gavage from days 1 to 39, and 3 mg / kg of diazepam (dissolved in 0.9% NaCl containing 1% DMSO) by gavage on day 40.

[0063] Forty minutes after gavage on day 40, the plus-maze test began. The test apparatus consisted of four arms, each approximately 25 by 5 cm, extending from a central, 5 by 5 cm, cross-shaped platform. Two opposing arms, enclosed by a 20 cm opaque wall, served as closed arms. The plus-maze was 50 cm above the ground. During the experiment, mice were placed on the central cross-shaped platform with their heads facing the open arms. The time the mice spent in each of the open and closed arms was recorded over the next 4 minutes.

[0064] The results are shown in Table 2, with the mean values ​​for mice within each group being used. Mice in Control 2 spent significantly more time in the open arms than those in Control 1 (P < 0.01), indicating a successful model. Mice given Composition 3 spent significantly more time in the open arms than those in Control 1 (P < 0.01) and Composition 4 (P < 0.01), achieving statistically significant differences and even surpassing Control 2. This indicates that Composition 3 has an anxiolytic effect, while Composition 4 does not.

[0065] Table 2. Plus maze test

[0066]

[0067] Example 4. Anti-aging function test of the composition

[0068] Human WI-38 fibroblasts were cultured in DMEM medium supplemented with 10% fetal bovine serum and maintained in a low-concentration hydrogen peroxide for 20 hours to induce cellular aging caused by oxidative stress. An aqueous suspension of Composition 3 prepared as described above (an equal amount of water was used in the negative control group) was added to the cells and gently shaken for 30 hours. β-galactosidase activity in the cells was measured using a β-galactosidase staining kit, and the cells were observed under a microscope. The results showed that the ratio of blue-stained cells in Composition 3 was numerically lower than that in the negative control group (38% vs. 46%), indicating some anti-aging activity.

[0069] Example 5. Preparation of formulations

[0070] 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 jujube seed, 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 leaf, 70 parts by weight of snow lotus, 60 parts by weight of Gastrodia elata, and 50 parts by weight of passionflower; wash them separately with water, air-dry them at room temperature, and grind them into powder. The mixture was 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 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 were added, and mixed again (to obtain a solid powder composition 3, AMX-SLE-03); sterilized, and an oral dosage form was prepared using an oral dosage form process.

[0071] Preparation Example 2: 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 jujube seed, 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 leaf, 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 stir. The preparation method comprises the following steps: washing, air-drying at room temperature, and crushing 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 gamma-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, and mixing again; sterilizing by irradiation, granulating, drying, and granulating to obtain granules.

[0072] Preparation Example 3: 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 jujube seed, 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 leaf, 70 parts by weight of snow lotus, 60 parts by weight of Gastrodia elata, and 50 parts by weight of passion flower; 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; 70% ethanol with a volume fraction of 4% by weight 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 3 h; and granulated to obtain granules.

[0073] 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.

[0074] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any other manner. Any person skilled in the art may utilize the above-disclosed technical content to modify or modify the present invention into equivalent embodiments. However, any simple modifications, equivalent variations, and modifications to the above embodiments that do not depart from the technical content of the present invention and are based on the technical essence of the present invention remain within the scope of protection 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: 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 spinach seed, 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 bamboo leaf, 70 parts by weight of snow lotus, 60 parts by weight of gastrodia elata, 50 parts by weight of passionflower, 25 parts by weight of ergothioneine, 10 parts by weight of dihydroquercetin, 30 parts by weight of gamma-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.

2. A pharmaceutical preparation for improving sleep, preventing and treating anxiety, and delaying aging, characterized in that: The pharmaceutical preparation comprises: the composition according to claim 1, and a pharmaceutically acceptable carrier.

3. The pharmaceutical preparation according to claim 2, wherein The pharmaceutical preparation is in the form of tablets, capsules, granules, oral liquids, dropping pills or micropills.

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