A medicine-food homologous composition for improving sleep and preparation method thereof

Abstract

The invention discloses a medicine-food homologous composition for improving sleep, the medicine-food homologous composition comprises: oats, mung beans, roses, lilies, fermented extracts and solubilizers, wherein the fermented extract is a mixed powder obtained by pulverizing and sieving together Semen Ziziphi Spinosae, Acanthopanax Senticosus, Poria, Euryale ferox and Taraxacum officinale, adding water and heating to boiling extraction for 20-30 minutes, and cooling to obtain a fermentation substrate; adding composite bacteria to the fermentation substrate, stirring evenly, fermenting, centrifuging for 10-15 minutes, taking the supernatant, spray drying, and obtaining a fermentation extract. The composite bacterial agent comprises Lactobacillus pentosus, Lactobacillus rhamnosus and Brevibacterium flavum. The solubilizer is modified pectin and / or sodium hyaluronate. In addition, a preparation method is also disclosed. The medicine-food homologous composition prepared by the present invention is not only low in cost and helps improve sleep, but also has a stable product and a simple preparation process.

Description

Technical Field

[0001] The present invention belongs to the technical field of functional foods, and more specifically, to a medicine-food composition for improving sleep and a preparation method thereof. Background Art

[0002] When sleep is disturbed, it manifests as difficulty falling asleep, shallow sleep, frequent night awakenings, and a decrease in overall sleep quality. These adverse phenomena not only have a direct impact on the body, such as physical exhaustion, dizziness, and even pain, but also bring many mental problems, including difficulty concentrating, memory loss, low mood, and even depression. Sleep disorders are fundamentally an imbalance between sleep duration and quality, and a disruption of the normal alternation of sleep and wakefulness cycles.

[0003] At present, we have a variety of coping strategies for insomnia, among which non-drug therapies such as cognitive behavioral therapy and physical therapy help patients adjust their sleep patterns in their unique ways. In terms of drug therapy, it covers a variety of options such as benzodiazepine sleeping pills, non-benzodiazepine sleeping pills and Chinese herbal medicine therapy. In view of the fact that the mainstream sleeping pills on the market, such as benzodiazepines and non-benzodiazepines, although they can take effect quickly and have significant effects, they are accompanied by significant side effects and potential risks of dependence and addiction; on the contrary, although traditional Chinese herbal medicines for the treatment of insomnia are relatively safe, they face challenges such as low absorption and utilization rate of active ingredients of drugs, slow efficacy, and long treatment cycles. In order to overcome these limitations, the present invention innovatively proposes a medicine-food composition for improving sleep and a preparation method thereof. Summary of the invention

[0004] In view of the deficiencies in the prior art, the present invention provides a medicine-food composition for improving sleep and a preparation method thereof.

[0005] In a first aspect, the present invention provides a medicinal and edible composition for improving sleep, comprising the following raw materials in parts by weight: 20-30 parts of oats, 10-20 parts of mung beans, 8-12 parts of roses, 8-12 parts of lilies, 5-8 parts of fermented extracts, and 1-3 parts of solubilizers.

[0006] Preferably, the following raw materials are included in parts by weight: 25 parts of oats, 15 parts of mung beans, 10 parts of roses, 10 parts of lilies, 6 parts of fermentation extract, and 2 parts of solubilizer.

[0007] Preferably, the fermentation extract is prepared by the following method:

[0008] (1) Grind the Chinese date seeds, Acanthopanax senticosus, Poria cocos, Euryale ferox and Taraxacum officinale together and pass through a 100-200 mesh sieve to obtain a mixed powder; control the mass ratio of the mixed powder to deionized water to be 1:8-12, mix the mixed powder with deionized water, heat to boiling and extract for 20-30 minutes, and cool to obtain a fermentation substrate;

[0009] (2) Add the composite bacteria to the fermentation substrate, stir evenly, ferment for 24-36 hours, then centrifuge at 8000-10000 rpm for 10-15 minutes, take the supernatant, spray dry, and obtain a fermentation extract.

[0010] Preferably, in step (1), the mass ratio of Semen Ziziphi Spinosae, Acanthopanax Senticosus, Poria, Euryale ferox and Taraxacum Herba is 20-30:18-25:10-15:10-15:5-10.

[0011] Preferably, in step (2), the number of viable bacteria in the fermentation substrate is controlled to be 2.5 x 10 9 -3.5x10 9 CFU / g.

[0012] Preferably, the composite bacteria include Lactobacillus pentosus, Lactobacillus rhamnosus and Brevibacterium flavum in a live bacteria count ratio of 1:1:0.3-0.5.

[0013] Preferably, the solubilizer is modified pectin and / or sodium hyaluronate.

[0014] Preferably, the solubilizer comprises modified pectin and sodium hyaluronate in a mass ratio of 4:1.

[0015] Preferably, the modified pectin is prepared by the following method:

[0016] A. Add sodium bicarbonate to water and stir to dissolve to prepare a sodium bicarbonate solution with a mass concentration of 0.5-1%;

[0017] B. Add pectin to the sodium bicarbonate solution while stirring, control the stirring rate to 300-500rpm, add acid to adjust the pH to 6-8, stir for 10-20min, add calcium chloride and continue stirring for 30-50min, place in a low-temperature oven at 40-60℃ and dry to constant weight to obtain modified pectin.

[0018] Preferably, the mass ratio of the pectin, the sodium bicarbonate solution and the calcium chloride is 1:7-9:0.1-0.3.

[0019] On the other hand, a method for preparing a medicine-food composition for improving sleep of the present invention comprises the following steps:

[0020] S1. After adding the solubilizer and deionized water and stirring to disperse evenly, add the fermentation extract and continue stirring to mix evenly, and spray dry to obtain the active component;

[0021] S2. Grind the oats, mung beans, roses and lilies together and pass through a 100-200 mesh sieve, add the active ingredients and mix evenly, sterilize and package to obtain the desired medicine and food composition.

[0022] Preferably, the step S2 further comprises: the medicine-food composition is in the form of tablets, pills, capsules or powders.

[0023] In summary, the present invention has the following beneficial effects:

[0024] The present invention selects natural edible plants oat, mung bean, rose, lily and co-fermented extracts of jujube seed, Acanthopanax senticosus, Poria, Euryale ferox and dandelion as raw materials, and the prepared medicine and food composition not only has the significant effects of clearing the heart and relieving troubles, calming the nerves and replenishing qi, and improving sleep, but also has the advantages of high absorption and utilization rate of effective ingredients, fast onset, short period of treatment of insomnia, etc. The preparation method of the present invention is simple, low cost, and the obtained medicine and food composition is convenient to take and carry, has good taste, and patients are highly motivated to take it.

[0025] The fermentation substrate is prepared by taking Chinese jujube seed, Acanthopanax senticosus, Poria cocos, Euryale ferox and dandelion as raw materials, wherein the Chinese jujube seed helps to calm the mind, improve sleep quality and relieve anxiety and tension; Acanthopanax senticosus can enhance the body's stress resistance, regulate the nervous system and promote psychological balance; in addition, Poria cocos helps to invigorate the spleen and promote diuresis and improve the spleen and stomach functions; Euryale ferox has the effects of invigorating the kidney and consolidating essence, invigorating the spleen and benefiting the stomach; and Dandelion has the effects of clearing away heat and detoxifying, and diuresis, and can help improve the function of the digestive system. The combined effects of the various raw materials can help improve the overall physical fitness and improve the sleep quality.

[0026] The present invention introduces Lactobacillus pentosus, Lactobacillus rhamnosus and Brevibacterium flavum as fermentation strains, wherein Lactobacillus pentosus exhibits its unique proteolytic ability during the fermentation process, and it finely decomposes the soluble protein in the fermentation matrix into small molecular compounds, which are not only easier to be absorbed and utilized by the organism, but also promote the further transformation of the fermentation system. Lactobacillus rhamnosus releases organic acids such as lactic acid through metabolic activities, reduces the pH value of the fermentation matrix, effectively avoids the growth of harmful microorganisms, and thus ensures the safety and effectiveness of the fermentation process; Lactobacillus rhamnosus can also secrete biologically active substances such as extracellular polysaccharides, which show significant effects in improving the texture of fermented products and improving nutritional value. The beneficial amino acids such as L-leucine produced by Brevibacterium flavum have become the key factors in enhancing the function of probiotics. L-leucine can not only promote the growth and metabolic activities of probiotics such as Lactobacillus pentosus, improve fermentation efficiency, but also comprehensively improve the nutritional value and biological activity of fermented products by promoting protein synthesis and energy metabolism. The multi-strain synergistic mode of the present invention not only realizes a more efficient and higher-quality fermentation production process, but also enriches the types of fermentation products in the fermentation process. The fermentation extract obtained by the present invention is not only rich in active pharmaceutical ingredients for treating insomnia, but also rich in small molecule polysaccharides and amino acids and other ingredients that are beneficial to the human body, making it easier to be absorbed by the human body. The synergistic effect between these ingredients provides a good basis for improving sleep disorders and helps solve various sleep problems.

[0027] The present invention adopts modified pectin and sodium hyaluronate as a solubilizer, which can improve the solubility of the active ingredients of the medicine in the digestive system, improve its bioavailability, make the active ingredients more easily absorbed by the body, thereby increasing the speed of onset and improving the therapeutic effect. The composite solubilizer of the present invention also has good stability, can protect the active ingredients of the medicine, prolong its shelf life, and reduce the risk of drug degradation during storage and transportation. DETAILED DESCRIPTION

[0028] The present application is further described in detail below in conjunction with the examples, but is not limited thereto. Other features and advantages disclosed in the present application will become apparent from the following detailed description and examples, which should not be construed as limiting.

[0029] Example 1

[0030] A medicine-food composition for improving sleep comprises the following raw materials in parts by weight: 20 parts of oats, 10 parts of mung beans, 8 parts of roses, 8 parts of lilies, 5 parts of fermented extracts, and 1 part of a solubilizer.

[0031] Wherein, the fermentation extract is prepared by the following method:

[0032] (1) Grind 20 parts of Ziziphus jujuba seeds, 18 parts of Acanthopanax senticosus, 10 parts of Poria cocos, 10 parts of Euryale ferox and 5 parts of Taraxacum officinale together and pass through a 200-mesh sieve to obtain a mixed powder; control the mass ratio of the mixed powder to deionized water to be 1:8, mix the mixed powder with deionized water, heat to boiling and extract for 20 minutes, and cool to obtain a fermentation substrate;

[0033] (2) Add the composite bacteria to the fermentation substrate, stir evenly, ferment for 24 hours, and then centrifuge at 10,000 rpm for 10 minutes. Take the supernatant, spray dry, and obtain the fermentation extract.

[0034] The composite bacteria include Lactobacillus pentosus, Lactobacillus rhamnosus and Brevibacterium flavum with a live bacterial count ratio of 1:1:0.3; the live bacterial count in the fermentation substrate is 2.5x10 9 CFU / g.

[0035] Wherein, the solubilizing agent is prepared by the following method:

[0036] A. Add sodium bicarbonate to water and stir to dissolve to prepare a sodium bicarbonate solution with a mass concentration of 1%;

[0037] B. Add pectin to the sodium bicarbonate solution while stirring, control the stirring rate to 500 rpm, add citric acid to adjust the pH to 8, stir for 10 minutes, add calcium chloride and continue stirring for 30 minutes, place in a low-temperature oven at 60°C and dry to constant weight to obtain modified pectin;

[0038] C. Evenly mix the modified pectin and sodium hyaluronate in a mass ratio of 4:1 to obtain a solubilizer.

[0039] Among them, the mass ratio of pectin, sodium bicarbonate solution and calcium chloride is 1:7:0.1.

[0040] A method for preparing a medicine-food composition for improving sleep, comprising the following steps:

[0041] S1. After adding 3 times the amount of deionized water to the solubilizer and stirring to disperse evenly, add the fermentation extract and continue stirring to mix evenly, and spray dry to obtain the active component;

[0042] S2. Grind oats, mung beans, roses and lilies together and pass through a 200-mesh sieve, add active ingredients and mix evenly, sterilize and package to obtain the desired medicine-food composition, wherein the dosage form of the medicine-food composition is tablets.

[0043] Example 2

[0044] A medicine-food composition for improving sleep comprises the following raw materials in parts by weight: 30 parts of oats, 20 parts of mung beans, 12 parts of roses, 12 parts of lilies, 8 parts of fermented extracts, and 3 parts of solubilizers.

[0045] Wherein, the fermentation extract is prepared by the following method:

[0046] (1) 30 parts of Ziziphus jujuba seeds, 25 parts of Acanthopanax senticosus, 15 parts of Poria cocos, 15 parts of Euryale ferox and 10 parts of Taraxacum officinale were pulverized together and passed through a 100-mesh sieve to obtain a mixed powder; the mass ratio of the mixed powder to deionized water was controlled to be 1:12, the mixed powder was mixed with deionized water, heated to boiling and extracted for 20 minutes, and cooled to obtain a fermentation substrate;

[0047] (2) Add the composite bacteria to the fermentation substrate, stir evenly, ferment for 36 hours, and then centrifuge at 8000 rpm for 15 minutes. Take the supernatant and spray dry to obtain the fermentation extract.

[0048] The composite bacteria include Lactobacillus pentosus, Lactobacillus rhamnosus and Brevibacterium flavum with a live bacterial count ratio of 1:1:0.5; the live bacterial count in the fermentation substrate is 3.5x10 9 CFU / g.

[0049] Wherein, the solubilizing agent is prepared by the following method:

[0050] A. Add sodium bicarbonate to water and stir to dissolve to prepare a sodium bicarbonate solution with a mass concentration of 0.5%;

[0051] B. Add pectin to the sodium bicarbonate solution while stirring, control the stirring rate to 300 rpm, add citric acid to adjust the pH to 6, stir for 20 minutes, add calcium chloride and continue stirring for 50 minutes, place in a low-temperature oven at 40°C and dry to constant weight to obtain modified pectin;

[0052] C. Evenly mix the modified pectin and sodium hyaluronate in a mass ratio of 4:1 to obtain a solubilizer.

[0053] Among them, the mass ratio of pectin, sodium bicarbonate solution and calcium chloride is 1:9:0.3.

[0054] A method for preparing a medicine-food composition for improving sleep, comprising the following steps:

[0055] S1. Add 4 times the amount of deionized water to the solubilizer and stir to disperse evenly, then add the fermentation extract and continue to stir and mix evenly, and spray dry to obtain the active component;

[0056] S2. Grind oats, mung beans, roses and lilies together and pass through a 100-mesh sieve, add active ingredients and mix evenly, sterilize and package to obtain the desired medicine-food composition, wherein the dosage form of the medicine-food composition is pills.

[0057] Example 3

[0058] A medicine-food composition for improving sleep comprises the following raw materials in parts by weight: 25 parts of oats, 15 parts of mung beans, 10 parts of roses, 10 parts of lilies, 6 parts of fermented extracts, and 2 parts of solubilizers.

[0059] Wherein, the fermentation extract is prepared by the following method:

[0060] (1) Grind 25 parts of Ziziphus jujuba seeds, 20 parts of Acanthopanax senticosus, 13 parts of Poria cocos, 13 parts of Euryale ferox and 8 parts of Taraxacum officinale together and pass through a 100-mesh sieve to obtain a mixed powder; control the mass ratio of the mixed powder to deionized water to be 1:10, mix the mixed powder with deionized water, heat to boiling and extract for 25 minutes, and cool to obtain a fermentation substrate;

[0061] (2) Add the composite bacteria to the fermentation substrate, stir evenly, ferment for 30 hours, and then centrifuge at 9000 rpm for 12 minutes. Take the supernatant, spray dry, and obtain the fermentation extract.

[0062] The composite bacteria include Lactobacillus pentosus, Lactobacillus rhamnosus and Brevibacterium flavum with a live bacterial count ratio of 1:1:0.4; the live bacterial count in the fermentation substrate is 3.0x10 9 CFU / g.

[0063] Wherein, the solubilizing agent is prepared by the following method:

[0064] A. Add sodium bicarbonate to water and stir to dissolve to prepare a sodium bicarbonate solution with a mass concentration of 0.6%;

[0065] B. Add pectin to the sodium bicarbonate solution while stirring, control the stirring rate to 350 rpm, add citric acid to adjust the pH to 6.5, stir for 18 minutes, add calcium chloride and continue stirring for 45 minutes, place in a low-temperature oven at 45°C and dry to constant weight to obtain modified pectin;

[0066] C. Evenly mix the modified pectin and sodium hyaluronate in a mass ratio of 4:1 to obtain a solubilizer.

[0067] Among them, the mass ratio of pectin, sodium bicarbonate solution and calcium chloride is 1:8:0.2.

[0068] A method for preparing a medicine-food composition for improving sleep, comprising the following steps:

[0069] S1. After adding 6 times the amount of deionized water to the solubilizer and stirring to disperse evenly, add the fermentation extract and continue stirring to mix evenly, and spray dry to obtain the active component;

[0070] S2. Grind oats, mung beans, roses and lilies together and pass through a 100-mesh sieve, add active ingredients and mix evenly, sterilize and package to obtain the desired medicine-food composition, wherein the dosage form of the medicine-food composition is capsules.

[0071] Example 4

[0072] A medicine-food composition for improving sleep comprises the following raw materials in parts by weight: 28 parts of oats, 17 parts of mung beans, 12 parts of roses, 12 parts of lilies, 7 parts of fermented extracts, and 2 parts of solubilizers.

[0073] Wherein, the fermentation extract is prepared by the following method:

[0074] (1) Grind 23 parts of Ziziphus jujuba seeds, 22 parts of Acanthopanax senticosus, 14 parts of Poria cocos, 12 parts of Euryale ferox and 10 parts of Taraxacum officinale together and pass through a 200-mesh sieve to obtain a mixed powder; control the mass ratio of the mixed powder to deionized water to be 1:9, mix the mixed powder with deionized water, heat to boiling and extract for 28 minutes, and cool to obtain a fermentation substrate;

[0075] (2) Add the composite bacteria to the fermentation substrate, stir evenly, ferment for 32 hours, and then centrifuge at 8500 rpm for 12 minutes. Take the supernatant and spray dry to obtain the fermentation extract.

[0076] The composite bacteria include Lactobacillus pentosus, Lactobacillus rhamnosus and Brevibacterium flavum with a live bacterial count ratio of 1:1:0.3; the live bacterial count in the fermentation substrate is 2.5x10 9 CFU / g.

[0077] Wherein, the solubilizing agent is prepared by the following method:

[0078] A. Add sodium bicarbonate to water and stir to dissolve to prepare a sodium bicarbonate solution with a mass concentration of 0.7%;

[0079] B. Add pectin to the sodium bicarbonate solution while stirring, control the stirring rate to 400 rpm, add citric acid to adjust the pH to 7, stir for 15 minutes, add calcium chloride and continue stirring for 40 minutes, place in a low-temperature oven at 50°C and dry to constant weight to obtain modified pectin;

[0080] C. Evenly mix the modified pectin and sodium hyaluronate in a mass ratio of 1:1 to obtain a solubilizer.

[0081] Among them, the mass ratio of pectin, sodium bicarbonate solution and calcium chloride is 1:7:0.3.

[0082] A method for preparing a medicine-food composition for improving sleep, comprising the following steps:

[0083] S1. After adding 7 times of deionized water to the solubilizer and stirring to disperse evenly, add the fermentation extract and continue stirring to mix evenly, and spray dry to obtain the active component;

[0084] S2. Grind oats, mung beans, roses and lilies together and pass through a 200-mesh sieve, add active ingredients and mix evenly, sterilize and package to obtain the desired medicine-food composition, wherein the dosage form of the medicine-food composition is powder.

[0085] Example 5

[0086] A medicine-food composition for improving sleep comprises the following raw materials in parts by weight: 28 parts of oats, 20 parts of mung beans, 9 parts of roses, 9 parts of lilies, 7 parts of fermented extracts, and 2 parts of solubilizers.

[0087] Wherein, the fermentation extract is prepared by the following method:

[0088] (1) Grind 24 parts of Ziziphus jujuba seeds, 22 parts of Acanthopanax senticosus, 12 parts of Poria cocos, 14 parts of Euryale ferox and 9 parts of Taraxacum officinale together and pass through a 100-mesh sieve to obtain a mixed powder; control the mass ratio of the mixed powder to deionized water to be 1:11, mix the mixed powder with deionized water, heat to boiling and extract for 26 minutes, and cool to obtain a fermentation substrate;

[0089] (2) Add the composite bacteria to the fermentation substrate, stir evenly, ferment for 30 hours, and then centrifuge at 10,000 rpm for 12 minutes. Take the supernatant, spray dry, and obtain the fermentation extract.

[0090] The composite bacteria include Lactobacillus pentosus, Lactobacillus rhamnosus and Brevibacterium flavum with a live bacterial count ratio of 1:1:0.4; the live bacterial count in the fermentation substrate is 3.2x10 9 CFU / g.

[0091] Wherein, the solubilizing agent is prepared by the following method:

[0092] A. Add sodium bicarbonate to water and stir to dissolve to prepare a sodium bicarbonate solution with a mass concentration of 0.9%;

[0093] B. Add pectin to the sodium bicarbonate solution while stirring, control the stirring rate to 450 rpm, add citric acid to adjust the pH to 7.5, stir for 12 minutes, add calcium chloride and continue stirring for 35 minutes, place in a low-temperature oven at 55°C and dry to constant weight to obtain modified pectin;

[0094] C. Evenly mix sodium hyaluronate and modified pectin in a mass ratio of 4:1 to obtain a solubilizer.

[0095] Among them, the mass ratio of pectin, sodium bicarbonate solution and calcium chloride is 1:9:0.1.

[0096] A method for preparing a medicine-food composition for improving sleep, comprising the following steps:

[0097] S1. After adding 8 times the amount of deionized water to the solubilizer and stirring to disperse evenly, add the fermentation extract and continue stirring to mix evenly, and spray dry to obtain the active component;

[0098] S2. Grind oats, mung beans, roses and lilies together and pass through a 100-mesh sieve, add active ingredients and mix evenly, sterilize and package to obtain the desired medicine-food composition, wherein the dosage form of the medicine-food composition is tablets.

[0099] Comparative Example 1

[0100] A medicine-food composition for improving sleep comprises the following raw materials in parts by weight: 28 parts of oats, 20 parts of mung beans, 9 parts of roses, 9 parts of lilies, 7 parts of fermented extracts, and 2 parts of solubilizers.

[0101] Wherein, the fermentation extract is prepared by the following method:

[0102] (1) Grind 24 parts of Ziziphus jujuba seeds, 22 parts of Acanthopanax senticosus, 12 parts of Poria cocos, 14 parts of Euryale ferox and 9 parts of Taraxacum officinale together and pass through a 100-mesh sieve to obtain a mixed powder; control the mass ratio of the mixed powder to deionized water to be 1:11, mix the mixed powder with deionized water, heat to boiling and extract for 26 minutes, and cool to obtain a fermentation substrate;

[0103] (2) Add the composite bacteria to the fermentation substrate, stir evenly, ferment for 30 hours, and then centrifuge at 10,000 rpm for 12 minutes. Take the supernatant, spray dry, and obtain the fermentation extract.

[0104] The composite bacteria include Lactobacillus pentosus and Lactobacillus rhamnosus with a live bacterial count ratio of 1:1; the live bacterial count in the fermentation substrate is 3.2x10 9 CFU / g.

[0105] Wherein, the solubilizing agent is prepared by the following method:

[0106] A. Add sodium bicarbonate to water and stir to dissolve to prepare a sodium bicarbonate solution with a mass concentration of 0.9%;

[0107] B. Add pectin to the sodium bicarbonate solution while stirring, control the stirring rate to 450 rpm, add citric acid to adjust the pH to 7.5, stir for 12 minutes, add calcium chloride and continue stirring for 35 minutes, place in a low-temperature oven at 55°C and dry to constant weight to obtain modified pectin;

[0108] C. Evenly mix the modified pectin and sodium hyaluronate in a mass ratio of 4:1 to obtain a solubilizer.

[0109] Among them, the mass ratio of pectin, sodium bicarbonate solution and calcium chloride is 1:9:0.1.

[0110] A method for preparing a medicine-food composition for improving sleep, comprising the following steps:

[0111] S1. After adding 8 times the amount of deionized water to the solubilizer and stirring to disperse evenly, add the fermentation extract and continue stirring to mix evenly, and spray dry to obtain the active component;

[0112] S2. Grind oats, mung beans, roses and lilies together and pass through a 100-mesh sieve, add active ingredients and mix evenly, sterilize and package to obtain the desired medicine-food composition, wherein the dosage form of the medicine-food composition is tablets.

[0113] Comparative Example 2

[0114] A medicine-food composition for improving sleep comprises the following raw materials in parts by weight: 28 parts of oats, 20 parts of mung beans, 9 parts of roses, 9 parts of lilies, 7 parts of fermented extracts, and 2 parts of solubilizers.

[0115] Wherein, the fermentation extract is prepared by the following method:

[0116] (1) Grind 24 parts of Ziziphus jujuba seeds, 22 parts of Acanthopanax senticosus, 12 parts of Poria cocos, 14 parts of Euryale ferox and 9 parts of Taraxacum officinale together and pass through a 100-mesh sieve to obtain a mixed powder; control the mass ratio of the mixed powder to deionized water to be 1:11, mix the mixed powder with deionized water, heat to boiling and extract for 26 minutes, and cool to obtain a fermentation substrate;

[0117] (2) Add the composite bacteria to the fermentation substrate, stir evenly, ferment for 30 hours, and then centrifuge at 10,000 rpm for 12 minutes. Take the supernatant, spray dry, and obtain the fermentation extract.

[0118] The composite bacteria include Lactobacillus rhamnosus and Brevibacterium flavum with a live bacterial count ratio of 2:0.4; the live bacterial count in the fermentation substrate is 3.2x10 9 CFU / g.

[0119] Wherein, the solubilizing agent is prepared by the following method:

[0120] A. Add sodium bicarbonate to water and stir to dissolve to prepare a sodium bicarbonate solution with a mass concentration of 0.9%;

[0121] B. Add pectin to the sodium bicarbonate solution while stirring, control the stirring rate to 450 rpm, add citric acid to adjust the pH to 7.5, stir for 12 minutes, add calcium chloride and continue stirring for 35 minutes, place in a low-temperature oven at 55°C and dry to constant weight to obtain modified pectin;

[0122] C. Evenly mix the modified pectin and sodium hyaluronate in a mass ratio of 4:1 to obtain a solubilizer.

[0123] Among them, the mass ratio of pectin, sodium bicarbonate solution and calcium chloride is 1:9:0.1.

[0124] A method for preparing a medicine-food composition for improving sleep, comprising the following steps:

[0125] S1. After adding 8 times the amount of deionized water to the solubilizer and stirring to disperse evenly, add the fermentation extract and continue stirring to mix evenly, and spray dry to obtain the active component;

[0126] S2. Grind oats, mung beans, roses and lilies together and pass through a 100-mesh sieve, add active ingredients and mix evenly, sterilize and package to obtain the desired medicine-food composition, wherein the dosage form of the medicine-food composition is tablets.

[0127] Comparative Example 3

[0128] A medicine-food composition for improving sleep comprises the following raw materials in parts by weight: 28 parts of oats, 20 parts of mung beans, 9 parts of roses, 9 parts of lilies, 7 parts of fermented extracts, and 2 parts of solubilizers.

[0129] Wherein, the fermentation extract is prepared by the following method:

[0130] (1) Grind 24 parts of Ziziphus jujuba seeds, 22 parts of Acanthopanax senticosus, 12 parts of Poria cocos, 14 parts of Euryale ferox and 9 parts of Taraxacum officinale together and pass through a 100-mesh sieve to obtain a mixed powder; control the mass ratio of the mixed powder to deionized water to be 1:11, mix the mixed powder with deionized water, heat to boiling and extract for 26 minutes, and cool to obtain a fermentation substrate;

[0131] (2) Add the composite bacteria to the fermentation substrate, stir evenly, ferment for 30 hours, and then centrifuge at 10,000 rpm for 12 minutes. Take the supernatant, spray dry, and obtain the fermentation extract.

[0132] The composite bacteria include Lactobacillus pentosus and Brevibacterium flavum with a live bacterial count ratio of 2:0.4; the live bacterial count in the fermentation substrate is 3.2x10 9 CFU / g.

[0133] Wherein, the solubilizing agent is prepared by the following method:

[0134] A. Add sodium bicarbonate to water and stir to dissolve to prepare a sodium bicarbonate solution with a mass concentration of 0.9%;

[0135] B. Add pectin to the sodium bicarbonate solution while stirring, control the stirring rate to 450 rpm, add citric acid to adjust the pH to 7.5, stir for 12 minutes, add calcium chloride and continue stirring for 35 minutes, place in a low-temperature oven at 55°C and dry to constant weight to obtain modified pectin;

[0136] C. Evenly mix the modified pectin and sodium hyaluronate in a mass ratio of 4:1 to obtain a solubilizer.

[0137] Among them, the mass ratio of pectin, sodium bicarbonate solution and calcium chloride is 1:9:0.1.

[0138] A method for preparing a medicine-food composition for improving sleep, comprising the following steps:

[0139] S1. After adding 8 times the amount of deionized water to the solubilizer and stirring to disperse evenly, add the fermentation extract and continue stirring to mix evenly, and spray dry to obtain the active component;

[0140] S2. Grind oats, mung beans, roses and lilies together and pass through a 100-mesh sieve, add active ingredients and mix evenly, sterilize and package to obtain the desired medicine-food composition, wherein the dosage form of the medicine-food composition is tablets.

[0141] Comparative Example 4

[0142] A medicine-food composition for improving sleep comprises the following raw materials in parts by weight: 28 parts of oats, 20 parts of mung beans, 9 parts of roses, 9 parts of lilies, 7 parts of fermented extracts, and 2 parts of solubilizers.

[0143] Wherein, the fermentation extract is prepared by the following method:

[0144] (1) Grind 24 parts of Ziziphus jujuba seeds, 22 parts of Acanthopanax senticosus, 12 parts of Poria cocos, 14 parts of Euryale ferox and 9 parts of Taraxacum officinale together and pass through a 100-mesh sieve to obtain a mixed powder; control the mass ratio of the mixed powder to deionized water to be 1:11, mix the mixed powder with deionized water, heat to boiling and extract for 26 minutes, and cool to obtain a fermentation substrate;

[0145] (2) Add the composite bacteria to the fermentation substrate, stir evenly, ferment for 30 hours, and then centrifuge at 10,000 rpm for 12 minutes. Take the supernatant, spray dry, and obtain the fermentation extract.

[0146] The composite bacteria include Lactobacillus pentosus, Lactobacillus rhamnosus and Brevibacterium flavum with a live bacterial count ratio of 1:1:0.4; the live bacterial count in the fermentation substrate is 3.2x10 9 CFU / g.

[0147] The solubilizing agent is obtained by uniformly mixing pectin and sodium hyaluronate in a mass ratio of 4:1. A method for preparing a medicine-food composition for improving sleep comprises the following steps:

[0148] S1. After adding 8 times the amount of deionized water to the solubilizer and stirring to disperse evenly, add the fermentation extract and continue stirring to mix evenly, and spray dry to obtain the active component;

[0149] S2. Grind oats, mung beans, roses and lilies together and pass through a 100-mesh sieve, add active ingredients and mix evenly, sterilize and package to obtain the desired medicine-food composition, wherein the dosage form of the medicine-food composition is tablets.

[0150] Comparative Example 5

[0151] A medicine-food composition for improving sleep comprises the following raw materials in parts by weight: 28 parts of oats, 20 parts of mung beans, 9 parts of roses, 9 parts of lilies, 7 parts of fermented extracts, and 2 parts of modified pectin.

[0152] Wherein, the fermentation extract is prepared by the following method:

[0153] (1) Grind 24 parts of Ziziphus jujuba seeds, 22 parts of Acanthopanax senticosus, 12 parts of Poria cocos, 14 parts of Euryale ferox and 9 parts of Taraxacum officinale together and pass through a 100-mesh sieve to obtain a mixed powder; control the mass ratio of the mixed powder to deionized water to be 1:11, mix the mixed powder with deionized water, heat to boiling and extract for 26 minutes, and cool to obtain a fermentation substrate;

[0154] (2) Add the composite bacteria to the fermentation substrate, stir evenly, ferment for 30 hours, and then centrifuge at 10,000 rpm for 12 minutes. Take the supernatant, spray dry, and obtain the fermentation extract.

[0155] The composite bacteria include Lactobacillus pentosus, Lactobacillus rhamnosus and Brevibacterium flavum with a live bacterial count ratio of 1:1:0.4; the live bacterial count in the fermentation substrate is 3.2x10 9 CFU / g.

[0156] Wherein, the solubilizing agent is modified pectin, which is specifically prepared by the following method:

[0157] A. Add sodium bicarbonate to water and stir to dissolve to prepare a sodium bicarbonate solution with a mass concentration of 0.9%;

[0158] B. Add pectin to the sodium bicarbonate solution while stirring at a stirring rate of 450 rpm, add citric acid to adjust the pH to 7.5, stir for 12 minutes, add calcium chloride and continue stirring for 35 minutes, place in a low-temperature oven at 55°C and dry to constant weight to obtain modified pectin.

[0159] Among them, the mass ratio of pectin, sodium bicarbonate solution and calcium chloride is 1:9:0.1.

[0160] A method for preparing a medicine-food composition for improving sleep, comprising the following steps:

[0161] S1. After adding 8 times the amount of deionized water to the solubilizer and stirring to disperse evenly, add the fermentation extract and continue stirring to mix evenly, and spray dry to obtain the active component;

[0162] S2. Grind oats, mung beans, roses and lilies together and pass through a 100-mesh sieve, add active ingredients and mix evenly, sterilize and package to obtain the desired medicine-food composition, wherein the dosage form of the medicine-food composition is tablets.

[0163] Comparative Example 6

[0164] A medicine-food composition for improving sleep comprises the following raw materials in parts by weight: 28 parts of oats, 20 parts of mung beans, 9 parts of roses, 9 parts of lilies, 7 parts of fermented extracts, and 2 parts of sodium hyaluronate.

[0165] Wherein, the fermentation extract is prepared by the following method:

[0166] (1) Grind 24 parts of Ziziphus jujuba seeds, 22 parts of Acanthopanax senticosus, 12 parts of Poria cocos, 14 parts of Euryale ferox and 9 parts of Taraxacum officinale together and pass through a 100-mesh sieve to obtain a mixed powder; control the mass ratio of the mixed powder to deionized water to be 1:11, mix the mixed powder with deionized water, heat to boiling and extract for 26 minutes, and cool to obtain a fermentation substrate;

[0167] (2) Add the composite bacteria to the fermentation substrate, stir evenly, ferment for 30 hours, and then centrifuge at 10,000 rpm for 12 minutes. Take the supernatant, spray dry, and obtain the fermentation extract.

[0168] The composite bacteria include Lactobacillus pentosus, Lactobacillus rhamnosus and Brevibacterium flavum with a live bacterial count ratio of 1:1:0.4; the live bacterial count in the fermentation substrate is 3.2x10 9 CFU / g.

[0169] A method for preparing a medicine-food composition for improving sleep, comprising the following steps:

[0170] S1. After adding 8 times the amount of deionized water to sodium hyaluronate and stirring to disperse evenly, add the fermentation extract and continue stirring to mix evenly, and spray dry to obtain the active component;

[0171] S2. Grind oats, mung beans, roses and lilies together and pass through a 100-mesh sieve, add active ingredients and mix evenly, sterilize and package to obtain the desired medicine-food composition, wherein the dosage form of the medicine-food composition is tablets.

[0172] Performance Testing

[0173] Establishment of insomnia mouse model

[0174] Preparation of PCPA suspension: p-Chlorophenylalanine powder was added to normal saline, a small amount of sodium stearate was added, and ultrasonic dispersion was performed for 20 min to obtain a 30 mg / ml PCPA suspension.

[0175] Mouse model establishment: 120 healthy adult male ICR / JCL mice, weighing 20-30g, were divided into 12 groups after one week of adaptive feeding, with 10 mice in each group, respectively recorded as the control group, Example 1-5 group, and Comparative Example 1-6 group. The mice in Example 1-5 group and Comparative Example 1-6 group were intraperitoneally injected with PCPA suspension for 3 consecutive days; the control group was injected with the same dose of normal saline. After 24 to 36 hours of injection treatment, the mice in Example 1-5 group and Comparative Example 1-6 group showed significant physiological rhythm weakening characteristics, specifically manifested as a sudden decrease in daytime activity, a state of lethargy, and accompanied by an increase in aggressive behavior, which was significantly different from the control group mice, which strongly verified the effectiveness and success of the insomnia model construction.

[0176] Test drug administration

[0177] The edible-medicine compositions of Examples 1-5 and Comparative Examples 1-6 were mixed with deionized water at a mass ratio of 1:10 to obtain a medicament; the intragastric administration dose was 1.60 g / kg, once a day; and the control group was intragastrically administered with normal saline. The mice of Examples 1-5 were intragastrically administered with the edible-medicine compositions prepared in Examples 1-5, the mice of Comparative Examples 1-6 were intragastrically administered with the edible-medicine compositions prepared in Comparative Examples 1-6, and the mice of the control group were intragastrically administered with normal saline.

[0178] Experiment on prolonging sleep time with sodium pentobarbital

[0179] Each group of mice was gavaged for 14 consecutive days. 15 minutes after the last administration, each group of mice was intraperitoneally injected with sodium pentobarbital solution. The dose of sodium pentobarbital was 35 mg / kg, and the injection volume was 0.1 mL / 10 g based on the weight of the mice. In order to quantify the sleep effect induced by sodium pentobarbital, when the mice were placed in a dorsal recumbent position and failed to turn back to the normal position on their own for more than 1 minute in this state, they were considered to have entered a sleep state. The sleep duration of each group of mice was recorded.

[0180] Table 1

[0181]

[0182] Compared with the control group, the sleep time of each embodiment and comparative example was shortened to varying degrees, among which the embodiment was significantly better than the comparative example in extending the sleep time, and embodiment 3 (41.62 min) extended the sleep time most significantly.

[0183] Sodium barbiturate sleep latency test

[0184] Each group of mice was gavaged for 14 consecutive days. 15 minutes after the last administration, each group of mice was intraperitoneally injected with sodium pentobarbital solution. The sodium pentobarbital dose was 200 mg / kg, and the injection volume was 0.1 mL / 10 g based on the weight of the mice. When the mice were placed in a dorsal recumbent position and failed to turn back to the normal position on their own for more than 1 minute in this state, they were considered to have entered a sleeping state. The sleep latency of each group of mice was recorded.

[0185] Table 2

[0186]

[0187] The results show that the mice in the control group showed normal sleep latency, which is a typical sleep behavior characteristic of mice without any experimental interference. All mice in the experimental groups that received different gavage treatments showed poor sleep latency, but the sleep latency of the embodiment was significantly better than that of the control, and the medicine-food composition of Example 3 improved the sleep latency most significantly.

[0188] Further analysis showed that among all the experimental groups, the mice fed Example 3 showed the best effect of shortening sleep latency, with an average sleep latency of only 26.14 min, which was very different from the normal sleep latency and significantly lower than other examples and comparison examples, proving that the drug or treatment regimen in this example has the best efficacy in promoting mice to fall asleep quickly.

[0189] This specific embodiment is merely an explanation of the present application and is not a limitation of the present application. After reading this specification, those skilled in the art may make modifications to the present embodiment without any creative contribution as needed, but such modifications are protected by the patent law as long as they are within the scope of the claims of the present application.

Claims

1. A medicine-food composition for improving sleep, characterized in that: The invention comprises the following raw materials in parts by weight: 20-30 parts of oats, 10-20 parts of mung beans, 8-12 parts of roses, 8-12 parts of lilies, 5-8 parts of fermented extracts, and 1-3 parts of solubilizers; Wherein, the fermentation extract is prepared by the following method: (1) Grind the Chinese date seeds, Acanthopanax senticosus, Poria cocos, Euryale ferox and Taraxacum officinale together and pass through a 100-200 mesh sieve to obtain a mixed powder; control the mass ratio of the mixed powder to deionized water to be 1:8-12, mix the mixed powder with deionized water, heat to boiling and extract for 20-30 minutes, and cool to obtain a fermentation substrate; (2) adding the composite bacteria to the fermentation substrate, stirring evenly, fermenting for 24-36 hours, centrifuging at 8000-10000 rpm for 10-15 minutes, taking the supernatant, spray drying, and obtaining a fermentation extract; Wherein, in step (1), the mass ratio of Semen Ziziphi Spinosae, Acanthopanax Senticosus, Poria, Euryale ferox and Taraxacum Herba is 20-30:18-25:10-15:10-15:5-10; Wherein, in step (2), the number of viable bacteria in the fermentation substrate is controlled to be 2.5 x 10 9 -3.5x10 9 CFU / g; Wherein, the composite bacteria include Lactobacillus pentosus, Lactobacillus rhamnosus and Brevibacterium flavum in a live bacteria count ratio of 1:1:0.3-0.5; Wherein, the solubilizing agent comprises modified pectin and sodium hyaluronate in a mass ratio of 4:1; Wherein, the modified pectin is prepared by the following method: A. Add sodium bicarbonate to water and stir to dissolve to prepare a sodium bicarbonate solution with a mass concentration of 0.5-1%; B. Add pectin to the sodium bicarbonate solution while stirring, control the stirring rate to 300-500rpm, add acid to adjust the pH to 6-8, stir for 10-20min, add calcium chloride and continue stirring for 30-50min, place in a low-temperature oven at 40-60℃ and dry to constant weight to obtain modified pectin.

2. The medicine-food composition for improving sleep according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 25 parts of oats, 15 parts of mung beans, 10 parts of roses, 10 parts of lilies, 6 parts of fermentation extracts and 2 parts of solubilizers.

3. A method for preparing the medicine-food composition for improving sleep as claimed in any one of claims 1 to 2, characterized in that: The following steps are involved: S1. After adding the solubilizer and deionized water and stirring to disperse evenly, add the fermentation extract and continue stirring to mix evenly, and spray dry to obtain the active component; S2. Grind the oats, mung beans, roses and lilies together and pass through a 100-200 mesh sieve, add the active ingredients and mix evenly, sterilize and package to obtain the desired medicine and food composition.

4. The method for preparing the medicine-food composition for improving sleep according to claim 3, characterized in that: The step S2 also includes: the medicine-food composition is in the form of tablets, pills, capsules or powders.

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