Sleep-aiding solid food based on spina date seed composite formula and preparation method of sleep-aiding solid food

Abstract

The invention provides sleep-aiding solid food based on a spina date seed composite formula and a preparation method of the sleep-aiding solid food. The food comprises the following components in parts by weight: 20-40 parts of spina date seeds, 15-25 parts of longan aril, 25-35 parts of raw oysters, 10-20 parts of poria cocos, 4-8 parts of liquorice, 1-3 parts of ginseng, 3-7 parts of roses and food-grade auxiliary materials. The preparation method comprises the following steps: pretreating raw materials; the spina date seeds are subjected to water decoction and ethanol microwave extraction, the raw oysters are subjected to alkaline proteolysis, and the roses are subjected to differential compound extraction such as supercritical CO2 extraction; mixing and concentrating; and finally, mixing with auxiliary materials to form a solid beverage, a gel candy or a tablet candy. Through a scientific compound and compound extraction process, the extraction rate and the product content of active ingredients such as jujuboside and ferulic acid are remarkably improved, and multi-target synergistic sleep aiding is realized; by optimizing forming and packaging processes, the taste, the stability and the portability of the product are effectively improved, and the sleep-aiding solid food which is convenient to take and exact in effect is provided.

Description

Technical Field

[0001] This invention patent relates to the field of food technology, and in particular to a sleep-aiding solid food based on a compound formula of jujube seed and its preparation method. Background Technology

[0002] Sleep disorders are a widespread health problem, and there is an urgent market demand for safe and long-lasting sleep aids. Existing sleep aids are mainly divided into two categories: chemically synthesized drugs (such as benzodiazepines and melatonin receptor agonists) and products made from natural ingredients. While the former has a rapid onset of action, it carries potential risks such as dependence and residual effects; the latter is safer and better suited for long-term treatment.

[0003] In the field of natural sleep aids, represented by jujube seed, existing technologies have significant shortcomings: First, in terms of product form and user experience, traditional decoctions are inconvenient to carry and have poor taste; while existing solid forms (such as ordinary powders and tablets) often lack sufficient flavor correction, with a noticeable herbal odor, affecting user adherence to long-term use. Second, regarding the scientific nature of the formulation and synergistic effects, most products are single-ingredient or simple compound formulas of jujube seed, failing to systematically integrate the multi-pathway synergistic theory of traditional Chinese medicine, which emphasizes "nourishing blood and calming the mind, suppressing yang, and strengthening the spleen and relieving depression." The lack of scientific compatibility with raw materials such as longan pulp, raw oyster, poria cocos, ginseng, and rose results in a single target of action and insufficient potential to improve sleep depth. Third, in terms of raw material processing and component extraction, simple pulverization or single water decoction processes are commonly used, leading to low extraction efficiency of jujube seed fat-soluble saponins, raw oyster active peptides, and poria cocos polysaccharides, resulting in significant loss of active ingredients, unstable content of product markers, and difficulty in ensuring batch-to-batch consistency. Finally, regarding industrialization and product stability, there is a lack of systematic and replicable process solutions for how to stably integrate complex extracts of multi-flavored raw materials into solid food forms (such as solid beverages and gel candies) and solve problems such as compatibility, activity protection, moisture control, and storage stability.

[0004] Invention Patent Content

[0005] In view of this, the present invention aims to provide a sleep-aiding solid food based on a compound formula of jujube seed and its preparation method, so as to solve or alleviate the technical problems existing in the prior art.

[0006] The technical solution of this invention patent embodiment is implemented as follows: a sleep-aiding solid food based on a compound formula of jujube seed, comprising the following raw material components by weight: 20-40 parts of jujube seed, 15-25 parts of longan pulp, 25-35 parts of raw oyster, 10-20 parts of poria cocos, 4-8 parts of licorice, 1-3 parts of ginseng, 3-7 parts of rose, and food-grade excipients.

[0007] The preparation method of the sleep-aid solid food includes the following steps:

[0008] S1. Raw material pretreatment: The jujube seed, longan pulp, poria cocos, licorice and rose are crushed and passed through a 20-mesh sieve. The raw oyster is crushed and passed through an 80-mesh sieve. The ginseng is vacuum freeze-dried and then ultra-finely pulverized to a particle size ≤10μm.

[0009] S2. Compound extraction: Extract the core raw materials separately to obtain extracts or extracts, including at least: water decoction and ethanol microwave extraction of jujube seed, alkaline protease hydrolysis of raw oyster, water decoction extraction of ginseng, water decoction extraction of longan pulp, and supercritical CO2 extraction of rose.

[0010] S3. Mixing and Concentration: Mix all the extracts obtained in step S2 evenly, place them in a vacuum concentrator, and continue to concentrate until the relative density is 1.08-1.10 to obtain a mixed concentrate;

[0011] S4. Material Forming: The concentrated liquid obtained in step S3 is mixed with some or all of the food-grade excipients, and the sleep-aiding solid food is obtained through a forming process.

[0012] As an improvement, the food-grade excipients include at least two of the following: carrier, flavoring agent, filler, and lubricant; the sleep-aid solid food is a solid beverage, and its preparation method, step S4, specifically includes:

[0013] S4.1. Spray drying: Add maltodextrin as a carrier to the mixed concentrate obtained in step S3, stir and dissolve at 100 r / min for 5-15 min, and then spray dry under the conditions of inlet air temperature of 180℃, outlet air temperature of 80℃, feed rate of 20 mL / min and atomization pressure of 0.3 MPa. Pass through an 80 mesh sieve to obtain extract powder.

[0014] S4.2. Mixing and granulation: The extract powder is mixed evenly with filler and flavoring agent, and a binder is added to form a soft mass. Granulation is carried out under the following conditions: extrusion pressure 2-5MPa, side sealing pressure <3MPa, extrusion speed ≤35rad / min, feeding speed ≤64rad / min, granulation speed 60-120rad / min, and cooling temperature controlled at ≤15℃.

[0015] S4.3. Drying and granulation: After drying the wet granules at 55-65℃ for 1-3 hours, granulate them, add lubricant and mix evenly for 3-7 minutes, and then pass them through a 12-mesh sieve.

[0016] S4.4. Vacuum packaging: Aluminum foil composite bags are used, and the bags are sealed for 3 seconds under a vacuum of 0.09MPa and a sealing temperature of 120℃. Each bag is filled with 3-5g.

[0017] As an improvement, the food-grade excipients, by weight, include: 25-35 parts maltodextrin, 8-12 parts microcrystalline cellulose, 5-10 parts fructooligosaccharides, 0.1-0.5 parts steviol glycosides, 0.3-0.8 parts magnesium stearate, and 0.1-0.3 parts sodium citrate.

[0018] As an improvement, the food-grade excipients include gelling agents, sugars, grain flour, edible oils, and purified water; the sleep-aid solid food is a gel candy, and its preparation method, step S4, specifically includes:

[0019] S4.1. Preparation of auxiliary materials:

[0020] a. Preparation of gelatin solution: Mix agar and water at a mass ratio of 1:(20-25), heat at 85-95℃ for 1-3 minutes to dissolve, and then filter to obtain agar filtrate; mix the agar filtrate with an edible gelatin aqueous solution at a mass ratio of 1:(1-2) to obtain an agar-gelatin mixture;

[0021] b. Preparation of syrup: Mix honey, glucose, maltose, water and salad oil in a mass ratio of (20-30):(9-11):(9-11):(15-20):(5-10), boil to 100-120℃ and keep warm for 5-30 minutes, then cool to 10-15℃ for later use;

[0022] c. Preparation of grain paste: Mix refined grain flour with water at a mass ratio of 1:(3-5), heat to 100-120℃ and keep warm for later use;

[0023] S4.2. Mixed preparation:

[0024] a. Mix the concentrated liquid obtained in step S3 with the syrup at a mass ratio of 1:(15-25), let stand, and obtain the herbal syrup;

[0025] b. Mix the agar-gelatin mixture with the grain paste at a mass ratio of 2:(4-6) to obtain a mixture; the raw materials of the grain paste include at least one of starch, glutinous rice flour, and sorghum flour;

[0026] S4.3. Shaping and drying: Mix the herbal syrup with the mixture evenly, cool to 10-15℃ and keep warm for 30-90 minutes, then slice and dry at 40-50℃ for 20-40 minutes to obtain soft candy;

[0027] S4.4. Packaging: Individual aluminum foil bags are used. The heat sealing temperature is 105-115℃ and the heat sealing time is 1-3 seconds.

[0028] As an improvement, the food-grade excipients, by weight, include: 1-3 parts agar, 10-20 parts edible gelatin, 20-30 parts honey, 9-11 parts glucose, 9-11 parts maltose, 5-10 parts salad oil, 15-25 parts refined grain flour, and 80-120 parts purified water.

[0029] As an improvement, the food-grade excipients, by weight, include fillers, sweeteners, and lubricants; the sleep-aid solid food is a compressed candy, and its preparation method, step S4, specifically includes:

[0030] S4.1. Mixing: The extract powder obtained by spray drying the extract obtained in step S3 is mixed with fructooligosaccharides and microcrystalline cellulose for 25-35 min, xylitol is added and mixed for 10-20 min, and finally magnesium stearate is added and mixed for 2-7 min to obtain total mixed particles.

[0031] S4.2. Tableting: The total mixed granules are compressed into tablets under a pressure of 16-20kN;

[0032] S4.3. Packaging: The tablets are packaged in aluminum-plastic blister packs, and the heat sealing temperature is 125-135℃, and the heat sealing time is 1-3s.

[0033] As an improvement, the food-grade excipients include: 8-15 parts of fructooligosaccharides, 10-20 parts of microcrystalline cellulose, 15-25 parts of xylitol, and 0.5-1.5 parts of magnesium stearate.

[0034] As an improvement, in step S2:

[0035] The extraction method of jujube seed is as follows: jujube seed is decocted with 8 times and 6 times the amount of water respectively for 1-2 hours, and the filtrates are combined; the residue is soaked in 70-80% ethanol for 110-130 minutes, and then extracted under microwave power of 1400-1600W and temperature of 65-75℃ for 20-30 minutes. The combined filtrates are concentrated to a relative density of 1.05 under vacuum of 0.06-0.1MPa and temperature of 50-70℃ to obtain jujube seed extract;

[0036] The extraction method of ginseng is as follows: ginseng is decocted with 8 times and 6 times the amount of water for 1-2 hours respectively, and the filtrates are combined; the combined filtrates are concentrated to a relative density of 1.05 under a vacuum of 0.06-0.1MPa and a temperature of 50-70℃ to obtain ginseng extract;

[0037] The extraction method of the raw oyster is as follows: 0.3-0.5% alkaline protease is added to raw oyster powder, and the mixture is stirred and enzymatically hydrolyzed for 3-5 hours at a temperature of 45-55℃ and a pH of 7.0-8.0 at 40-60 r / min. After filtration through a plate and frame filter with a pore size of 0.45 μm, the mixture is concentrated to obtain the raw oyster extract.

[0038] The method for extracting longan pulp is as follows: Longan pulp is decocted with 8 times and 6 times the amount of water for 1-2 hours respectively, the filtrates are combined, and the extract is concentrated under reduced pressure at a vacuum of 0.06-0.10 MPa and a temperature of 55-65℃ to obtain longan pulp extract, which is then refrigerated for later use.

[0039] The extraction method for roses is as follows: supercritical CO2 extraction is used, ethanol is added to rose powder as an entrainer, the amount of entrainer is 5-15% of the weight of roses, the extraction pressure is set to 30-40 MPa, the extraction temperature is 45-55℃, the extraction time is 3-5 hours, and the CO2 flow rate is controlled at 15-25 L / h. After extraction, the extract is collected in a separation vessel to obtain rose extract.

[0040] As an improvement, step S2 further includes the extraction of Poria cocos and licorice: Poria cocos and licorice are mixed and decocted with 8 times and 6 times the amount of water, respectively, for 1-2 hours. The filtrates are combined, and papain and cellulase are added to the filtrates for enzymatic hydrolysis. The amount of enzymes added is 0.5%-2% of the total mass of Poria cocos and licorice, respectively. The temperature is adjusted to 45-55℃ and the pH to 5.5-6.5. The mixture is stirred and hydrolyzed for 20-40 minutes. After enzymatic hydrolysis, the mixture is filtered, and ethanol is added to the filtrate for reflux extraction for 0.5-1.5 hours. Finally, the mixture is concentrated under reduced pressure to obtain the Poria cocos and licorice extract.

[0041] As an improvement, the effective ingredient content of the sleep-aid solid food is: jujube seed saponin ≥1.0mg / g or ≥1.0mg / single dose, ferulic acid ≥0.6mg / g or ≥0.6mg / single dose.

[0042] The embodiments of this invention, by employing the above technical solutions, have the following advantages:

[0043] Based on traditional Chinese medicine theory, this invention scientifically combines jujube seed, longan pulp, raw oyster, poria cocos, licorice, ginseng, and rose to form a multi-pathway synergistic system that takes into account "nourishing the heart and calming the mind, strengthening the spleen and replenishing blood, calming the mind and suppressing yang, and soothing the liver and relieving depression". It comprehensively regulates the sleep-wake cycle from multiple physiological links, effectively overcoming the shortcomings of single-ingredient or simple compound products that have limited targets and limited improvement on sleep quality (especially deep sleep).

[0044] This invention employs differentiated extraction technologies tailored to the physicochemical properties of different raw materials, including "water decoction-ethanol microwave-assisted extraction" (jujube seed), alkaline proteolytic hydrolysis (raw oyster), supercritical CO2 extraction (rose), and compound enzymatic hydrolysis combined with alcohol extraction (poria cocos, licorice). These technologies significantly improve the extraction efficiency and purity of key active ingredients such as jujube seed saponins, ferulic acid, protein polypeptides, and polysaccharides, ensuring that the content of marker components in the final product is stable and significantly higher than that of conventional processes. This provides a material basis for the reliability of product efficacy and batch consistency.

[0045] This invention provides three specific molding process solutions for solid beverages, gel candies, and compressed candies. By optimizing the combination of excipients (such as maltodextrin carrier and agar-gelatin composite gelling system), precisely controlling process parameters (such as spray drying conditions, tableting pressure, and syrup cooking temperature), and using specific packaging (aluminum foil vacuum / individual bags), undesirable flavors are successfully masked and taste acceptance is improved, while heat-sensitive active ingredients are effectively protected and the product's water activity is effectively controlled. This ensures the physical, chemical, and microbiological stability of the product during storage, achieving a successful transformation from a highly efficient extract to a stable solid food that is easy to consume and suitable for large-scale production.

[0046] The above overview is for illustrative purposes only and is not intended to be limiting in any way. Further aspects, embodiments, and features of this invention will become readily apparent from the following detailed description, in addition to the illustrative aspects, embodiments, and features described above. Detailed Implementation

[0047] The invention will be more readily understood by referring to the following detailed description of preferred embodiments and included examples. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the definitions in this specification shall prevail.

[0048] As used herein, the terms “prepared from” and “comprising” are synonymous. The terms “comprising,” “including,” “having,” “containing,” or any other variations thereof, as used herein, are intended to cover non-exclusive inclusion. For example, a composition, step, method, article, or apparatus that includes the listed elements is not necessarily limited to those elements, but may include other elements not expressly listed or elements inherent to such composition, step, method, article, or apparatus.

[0049] The conjunction "composed of..." excludes any unspecified elements, steps, or components. If used in a claim, this phrase makes the claim closed, excluding materials other than those described, except for associated conventional impurities. When the phrase "composed of..." appears in a clause of the body of a claim rather than immediately following it, it limits only the elements described in that clause; other elements are not excluded from the claim as a whole.

[0050] When a quantity, concentration, or other value or parameter is expressed as a range, a preferred range, or a range defined by a series of upper and lower preferred values, this should be understood as specifically disclosing all ranges formed by any pair of any upper or preferred value with any lower or preferred value, regardless of whether the range is disclosed individually. For example, when the range “1 to 5” is disclosed, the described range should be interpreted as including the ranges “1 to 4”, “1 to 3”, “1 to 2”, “1 to 2 and 4 to 5”, “1 to 3 and 5”, etc. When numerical ranges are described herein, unless otherwise stated, the range is intended to include its endpoints and all integers and fractions within that range.

[0051] The singular form includes the plural objects of discussion unless the context clearly indicates otherwise. "Optional" or "any one" means that the matter or event described thereafter may or may not occur, and the description includes both the possibility that the event occurs and the possibility that the event does not occur.

[0052] Approximate terms used in the specification and claims to modify quantities indicate that the invention is not limited to that specific quantity, but also includes acceptable modifications close to that quantity that do not alter the relevant essential function. Correspondingly, the use of "about," "approximately," etc., to modify a numerical value means that the invention is not limited to that precise value. In some instances, approximate terms may correspond to the precision of the instrument used to measure the value. In this application's specification and claims, scope definitions can be combined and / or interchanged, unless otherwise stated, these scopes include all subscopes contained therein.

[0053] Furthermore, the indefinite articles “a” and “an” preceding the elements or components of this invention do not impose any limitation on the quantity requirement (i.e., the number of times) of the elements or components. Therefore, “an” or “a” should be interpreted as including one or at least one, and the singular form of an element or component also includes the plural form, unless the quantity clearly refers to the singular form.

[0054] Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to this invention. The preferred embodiments and materials described herein are for illustrative purposes only and do not limit the scope of this application.

[0055] Unless otherwise specified, the experimental methods used in the following examples are conventional methods; unless otherwise specified, the experimental materials and test strains used in the following examples were purchased from commercial channels.

[0056] Example 1:

[0057] A sleep-aiding solid food based on a compound formula of jujube seed, comprising the following raw material components by weight: 20 parts jujube seed, 15 parts longan pulp, 25 parts raw oyster, 10 parts poria cocos, 4 parts licorice, 1 part ginseng, 3 parts rose, and food-grade excipients.

[0058] The preparation method of the sleep-aid solid food includes the following steps:

[0059] S1. Raw material pretreatment: The jujube seed, longan pulp, poria cocos, licorice and rose are crushed and passed through a 20-mesh sieve. The raw oyster is crushed and passed through an 80-mesh sieve. The ginseng is vacuum freeze-dried and then ultra-finely pulverized to a particle size ≤10μm.

[0060] S2. Compound extraction: Extract the core raw materials separately to obtain extracts or extracts, including at least: water decoction and ethanol microwave extraction of jujube seed, alkaline protease hydrolysis of raw oyster, water decoction extraction of ginseng, water decoction extraction of longan pulp, and supercritical CO2 extraction of rose.

[0061] Specifically, the extraction method of jujube seed is as follows: jujube seed is decocted with 8 times and 6 times the amount of water for 1 hour each, and the filtrates are combined; the residue is soaked in 70% ethanol for 110 minutes, and then extracted for 20 minutes at a microwave power of 1400W and a temperature of 65℃. The combined filtrates are concentrated to a relative density of 1.05 at a vacuum of 0.06MPa and a temperature of 50℃ to obtain jujube seed extract.

[0062] The ginseng extraction method is as follows: ginseng is decocted with 8 times and 6 times the amount of water for 1 hour each, and the filtrates are combined; the combined filtrates are concentrated to a relative density of 1.05 under a vacuum of 0.06 MPa and a temperature of 50°C to obtain ginseng extract;

[0063] The extraction method of the raw oyster is as follows: 0.3% alkaline protease is added to the raw oyster powder, and the mixture is stirred at 40 r / min for 3 hours under the conditions of 45℃ and pH 7.0. After filtration through a plate and frame filter with a pore size of 0.45 μm, the mixture is concentrated to obtain the raw oyster extract.

[0064] The method for extracting longan pulp is as follows: Longan pulp is decocted with 8 times and 6 times the amount of water for 1 hour respectively, the filtrates are combined, and the extract is concentrated under reduced pressure at a vacuum of 0.06 MPa and a temperature of 55°C to obtain longan pulp extract, which is then refrigerated for later use.

[0065] The extraction method for roses is as follows: supercritical CO2 extraction is used, ethanol is added to rose powder as an entrainer, the amount of the entrainer is 5% of the weight of the rose, the extraction pressure is set to 30 MPa, the extraction temperature is set to 45℃, the extraction is carried out for 3 hours, and the CO2 flow rate is controlled at 15 L / h. After the extraction is completed, the extract is collected in a separation vessel to obtain rose extract.

[0066] It also includes the extraction of Poria cocos and licorice: Poria cocos and licorice were mixed and decocted for 1 hour each with 8 times and 6 times the amount of water, respectively. The filtrates were combined, and papain and cellulase were added to the filtrates for enzymatic hydrolysis. The amount of enzymes added was 0.5% of the total mass of Poria cocos and licorice, respectively. The temperature was adjusted to 45℃ and the pH to 5.5. The mixture was stirred and hydrolyzed for 20 minutes. After enzymatic hydrolysis, the mixture was filtered, and ethanol was added to the filtrate for reflux extraction for 0.5 hours. Finally, the mixture was concentrated under reduced pressure to obtain the Poria cocos and licorice extract.

[0067] S3. Mixing and Concentration: Mix all the extracts obtained in step S2 evenly, place them in a vacuum concentrator, and continue to concentrate until the relative density is 1.08 to obtain a mixed concentrate;

[0068] S4. Material Forming: The concentrated liquid obtained in step S3 is mixed with some or all of the food-grade excipients, and the sleep-aiding solid food is obtained through a forming process.

[0069] When the sleep-aid solid food is a solid beverage, the food-grade excipients include at least two of the following: carrier, flavoring agent, filler, and lubricant, and the preparation method includes:

[0070] S4.1. Spray drying: The mixed concentrate obtained in step S3 is added to maltodextrin as a carrier and stirred at 100 r / min for 5 min to dissolve. Then, spray drying is carried out under the conditions of inlet air temperature of 180℃, outlet air temperature of 80℃, feed rate of 20 mL / min and atomization pressure of 0.3 MPa. The extract powder is obtained by passing it through an 80-mesh sieve.

[0071] S4.2. Mixing and granulation: The extract powder is mixed evenly with filler and flavoring agent, and binder is added to form a soft material. Granulation is carried out under the following conditions: extrusion pressure 2MPa, side sealing pressure <3MPa, extrusion speed ≤35rad / min, feeding speed ≤64rad / min, granulation speed 60rad / min, and cooling temperature control ≤15℃.

[0072] S4.3. Drying and granulation: After drying the wet granules at 55℃ for 1 hour, granulate them, add lubricant and mix evenly for 3 minutes, then pass through a 12-mesh sieve;

[0073] S4.4. Vacuum packaging: Aluminum foil composite bags are used, and the bags are sealed for 3 seconds under a vacuum of 0.09MPa and a sealing temperature of 120℃. Each bag is filled with 3g.

[0074] The food-grade excipients, by weight, include: 25 parts maltodextrin, 8 parts microcrystalline cellulose, 5 parts fructooligosaccharides, 0.1 parts steviol glycosides, 0.3 parts magnesium stearate, and 0.1 parts sodium citrate.

[0075] When the sleep-aid solid food is a gel candy, the food-grade excipients include gelling agents, sugars, grain flour, edible oils, and purified water, and its preparation method includes:

[0076] S4.1. Preparation of auxiliary materials:

[0077] a. Preparation of gelatin solution: Mix agar and water at a mass ratio of 1:20, heat at 85°C for 1 minute to dissolve, and then filter to obtain agar filtrate; mix the agar filtrate with an edible gelatin aqueous solution at a mass ratio of 1:1 to obtain an agar-gelatin mixture;

[0078] b. Preparation of syrup: Mix honey, glucose, maltose, water and salad oil in a mass ratio of 20:9:9:15:5, boil to 100℃ and keep warm for 5 minutes, then cool to 10℃ for later use;

[0079] c. Preparation of grain paste: Mix refined grain flour with water at a mass ratio of 1:3, heat to 100℃ and keep warm for later use;

[0080] S4.2. Mixed preparation:

[0081] a. Mix the concentrated liquid obtained in step S3 with the syrup at a mass ratio of 1:15, let stand, and obtain the herbal syrup;

[0082] b. Mix the agar-gelatin mixture with the grain paste at a mass ratio of 2:4 to obtain a mixture; the raw materials of the grain paste include at least one of starch, glutinous rice flour, and sorghum flour;

[0083] S4.3. Shaping and drying: Mix the herbal syrup with the mixture evenly, cool to 10°C and keep warm for 30 minutes, then slice and dry at 40°C for 20 minutes to obtain soft candy;

[0084] S34. Packaging: Individual aluminum foil bags are used, with a heat-sealing temperature of 105℃ and a heat-sealing time of 1 second.

[0085] The food-grade excipients, by weight, include: 1 part agar, 10-20 parts edible gelatin, 20 parts honey, 9 parts glucose, 9 parts maltose, 5 parts salad oil, 15 parts refined grain flour, and 80 parts purified water.

[0086] When the sleep-aid solid food is a compressed candy, the food-grade excipients include fillers, sweeteners, and lubricants, and its preparation method includes:

[0087] S4.1. Mixing: The extract powder obtained by spray drying the extract obtained in step S3 is mixed with fructooligosaccharides and microcrystalline cellulose for 25 min, then xylitol is added and mixed for 10 min, and finally magnesium stearate is added and mixed for 2 min to obtain total mixed particles.

[0088] S4.2. Tableting: The total mixed particles are compressed into tablets under a pressure of 16kN;

[0089] S4.3. Packaging: The tablets are packaged in aluminum-plastic blister packs, and the heat sealing temperature is 125℃ and the heat sealing time is 1 second.

[0090] The food-grade excipients, by weight, include: 8 parts fructooligosaccharides, 10 parts microcrystalline cellulose, 15 parts xylitol, and 0.5 parts magnesium stearate.

[0091] The effective ingredient content of the sleep-aid solid food of the present invention is: jujube seed saponin ≥1.0mg / g or ≥1.0mg / single dose, ferulic acid ≥0.6mg / g or ≥0.6mg / single dose.

[0092] Example 2:

[0093] A sleep-aiding solid food based on a compound formula of jujube seed, comprising the following raw material components by weight: 30 parts jujube seed, 20 parts longan pulp, 30 parts raw oyster, 15 parts poria cocos, 6 parts licorice, 2 parts ginseng, 5 parts rose, and food-grade excipients.

[0094] The preparation method of the sleep-aid solid food includes the following steps:

[0095] S1. Raw material pretreatment: The jujube seed, longan pulp, poria cocos, licorice and rose are crushed and passed through a 20-mesh sieve. The raw oyster is crushed and passed through an 80-mesh sieve. The ginseng is vacuum freeze-dried and then ultra-finely pulverized to a particle size ≤10μm.

[0096] S2. Compound extraction: Extract the core raw materials separately to obtain extracts or extracts, including at least: water decoction and ethanol microwave extraction of jujube seed, alkaline protease hydrolysis of raw oyster, water decoction extraction of ginseng, water decoction extraction of longan pulp, and supercritical CO2 extraction of rose.

[0097] Specifically, the extraction method of jujube seed is as follows: jujube seed is decocted with 8 times and 6 times the amount of water for 1.5 hours respectively, and the filtrates are combined; the residue is soaked in 75% ethanol for 120 minutes, and then extracted for 25 minutes at a microwave power of 1500W and a temperature of 70℃. The combined filtrates are concentrated to a relative density of 1.05 at a vacuum of 0.08MPa and a temperature of 60℃ to obtain jujube seed extract.

[0098] The ginseng extraction method is as follows: ginseng is decocted with 8 times and 6 times the amount of water for 1.5 hours respectively, and the filtrates are combined; the combined filtrates are concentrated to a relative density of 1.05 under a vacuum of 0.08 MPa and a temperature of 60°C to obtain ginseng extract;

[0099] The extraction method of the raw oyster is as follows: 0.4% alkaline protease is added to the raw oyster powder, and the mixture is stirred at 50 r / min for 4 hours under the conditions of 50℃ and pH 7.5. After filtration through a plate and frame filter with a pore size of 0.45 μm, the mixture is concentrated to obtain the raw oyster extract.

[0100] The method for extracting longan pulp is as follows: Longan pulp is decocted with 8 times and 6 times the amount of water for 1.5 hours respectively, the filtrates are combined, and the extract is concentrated under reduced pressure at a vacuum of 0.08 MPa and a temperature of 60°C to obtain longan pulp extract, which is then refrigerated for later use.

[0101] The extraction method for roses is as follows: supercritical CO2 extraction is used, ethanol is added to rose powder as an entrainer, the amount of entrainer is 10% of the weight of roses, the extraction pressure is set to 35 MPa, the extraction temperature is set to 50℃, the extraction is carried out for 4 hours, and the CO2 flow rate is controlled at 20 L / h. After the extraction is completed, the extract is collected in a separation vessel to obtain rose extract.

[0102] It also includes the extraction of Poria cocos and licorice: Poria cocos and licorice were mixed and decocted with 8 times and 6 times the amount of water for 1.5 hours respectively. The filtrates were combined and papain and cellulase were added to the filtrates for enzymatic hydrolysis. The amount of enzyme added was 1.5% of the total mass of Poria cocos and licorice. The temperature was adjusted to 50℃ and the pH to 6. The mixture was stirred and hydrolyzed for 30 minutes. After enzymatic hydrolysis, the mixture was filtered and ethanol was added to the filtrate for reflux extraction for 1 hour. Finally, the mixture was concentrated under reduced pressure to obtain the Poria cocos and licorice extract.

[0103] S3. Mixing and Concentration: Mix all the extracts obtained in step S2 evenly, place them in a vacuum concentrator, and continue to concentrate until the relative density is 1.09 to obtain a mixed concentrate;

[0104] S4. Material Forming: The concentrated liquid obtained in step S3 is mixed with some or all of the food-grade excipients, and the sleep-aiding solid food is obtained through a forming process.

[0105] When the sleep-aid solid food is a solid beverage, the food-grade excipients include at least two of the following: carrier, flavoring agent, filler, and lubricant, and the preparation method includes:

[0106] S4.1. Spray drying: The mixed concentrate obtained in step S3 is added to maltodextrin as a carrier and stirred at 100 r / min for 10 min to dissolve. Then, spray drying is carried out under the conditions of inlet air temperature of 180℃, outlet air temperature of 80℃, feed rate of 20 mL / min and atomization pressure of 0.3 MPa. The extract powder is obtained by passing it through an 80-mesh sieve.

[0107] S4.2. Mixing and granulation: The extract powder is mixed evenly with filler and flavoring agent, and a binder is added to form a soft material. Granulation is carried out under the following conditions: extrusion pressure 2-5 MPa, side sealing pressure <3 MPa, extrusion speed ≤35 rad / min, feeding speed ≤64 rad / min, granulation speed 60-120 rad / min, and cooling temperature controlled at ≤15℃.

[0108] S4.3. Drying and granulation: After drying the wet granules at 60℃ for 2 hours, granulate them, add lubricant and mix evenly for 5 minutes, then pass through a 12-mesh sieve;

[0109] S4.4. Vacuum packaging: Aluminum foil composite bags are used, and the bags are sealed for 3 seconds under a vacuum of 0.09MPa and a sealing temperature of 120℃, with each bag containing 4g.

[0110] The food-grade excipients, by weight, include: 30 parts maltodextrin, 10 parts microcrystalline cellulose, 7 parts fructooligosaccharides, 0.3 parts steviol glycosides, 0.5 parts magnesium stearate, and 0.2 parts sodium citrate.

[0111] When the sleep-aid solid food is a gel candy, the food-grade excipients include gelling agents, sugars, grain flour, edible oils, and purified water, and its preparation method includes:

[0112] S4.1. Preparation of auxiliary materials:

[0113] a. Preparation of gelatin solution: Mix agar and water at a mass ratio of 1:23, heat at 90°C for 2 minutes to dissolve, and then filter to obtain agar filtrate; mix the agar filtrate with an edible gelatin aqueous solution at a mass ratio of 1:1.5 to obtain an agar-gelatin mixture;

[0114] b. Preparation of syrup: Mix honey, glucose, maltose, water and salad oil in a mass ratio of 25:10:10:17:7, boil to 110℃ and keep warm for 18 minutes, then cool to 13℃ for later use;

[0115] c. Preparation of grain paste: Mix refined grain flour with water at a mass ratio of 1:4, heat to 110℃ and keep warm for later use;

[0116] S4.2. Mixed preparation:

[0117] a. Mix the concentrated liquid obtained in step S3 with the syrup at a mass ratio of 1:20, let stand, and obtain the herbal syrup;

[0118] b. Mix the agar-gelatin mixture with the grain paste at a mass ratio of 2:5 to obtain a mixture; the raw materials of the grain paste include at least one of starch, glutinous rice flour, and sorghum flour;

[0119] S4.3. Shaping and drying: Mix the herbal syrup with the mixture evenly, cool to 13°C and keep warm for 60 minutes, then slice and dry at 45°C for 30 minutes to obtain soft candy;

[0120] S4.4. Packaging: Individual aluminum foil bags are used. The heat sealing temperature is 110℃ and the heat sealing time is 2s.

[0121] 25 parts of glucose, 10 parts of maltose, 7 parts of salad oil, 20 parts of refined grain flour, and 100 parts of purified water.

[0122] When the sleep-aid solid food is a compressed candy, the food-grade excipients include fillers, sweeteners, and lubricants, and its preparation method includes:

[0123] S4.1. Mixing: The extract powder obtained by spray drying the extract obtained in step S3 is mixed with fructooligosaccharides and microcrystalline cellulose for 30 min, then xylitol is added and mixed for 15 min, and finally magnesium stearate is added and mixed for 5 min to obtain total mixed particles.

[0124] S4.2. Tableting: The total mixed particles are compressed into tablets under a pressure of 18kN;

[0125] S4.3. Packaging: The tablets are packaged in aluminum-plastic blister packs, and the heat sealing temperature is 130℃ and the heat sealing time is 2s.

[0126] The food-grade excipients, by weight, include: 11 parts fructooligosaccharides, 15 parts microcrystalline cellulose, 20 parts xylitol, and 1 part magnesium stearate.

[0127] The effective ingredient content of the sleep-aid solid food of the present invention is: jujube seed saponin ≥1.0mg / g or ≥1.0mg / single dose, ferulic acid ≥0.6mg / g or ≥0.6mg / single dose.

[0128] Example 3:

[0129] A sleep-aiding solid food based on a compound formula of jujube seed, comprising the following raw material components by weight: 40 parts jujube seed, 25 parts longan pulp, 35 parts raw oyster, 20 parts poria cocos, 8 parts licorice, 3 parts ginseng, 7 parts rose, and food-grade excipients.

[0130] The preparation method of the sleep-aid solid food includes the following steps:

[0131] S1. Raw material pretreatment: The jujube seed, longan pulp, poria cocos, licorice and rose are crushed and passed through a 20-mesh sieve. The raw oyster is crushed and passed through an 80-mesh sieve. The ginseng is vacuum freeze-dried and then ultra-finely pulverized to a particle size ≤10μm.

[0132] S2. Compound extraction: Extract the core raw materials separately to obtain extracts or extracts, including at least: water decoction and ethanol microwave extraction of jujube seed, alkaline protease hydrolysis of raw oyster, water decoction extraction of ginseng, water decoction extraction of longan pulp, and supercritical CO2 extraction of rose.

[0133] Specifically, the extraction method of jujube seed is as follows: jujube seed is decocted with 8 times and 6 times the amount of water for 2 hours respectively, and the filtrates are combined; the residue is soaked in 80% ethanol for 130 minutes, and then extracted for 30 minutes at microwave power of 1600W and temperature of 75℃. The combined filtrates are concentrated to a relative density of 1.05 at vacuum degree of 0.1MPa and temperature of 70℃ to obtain jujube seed extract;

[0134] The ginseng extraction method is as follows: ginseng is decocted with 8 times and 6 times the amount of water for 2 hours respectively, and the filtrates are combined; the combined filtrates are concentrated to a relative density of 1.05 under a vacuum of 0.1 MPa and a temperature of 70°C to obtain ginseng extract;

[0135] The extraction method of the raw oyster is as follows: 0.5% alkaline protease is added to the raw oyster powder, and the mixture is stirred at 60 r / min for 5 hours under the conditions of 55℃ and pH 8.0. After filtration through a plate and frame filter with a pore size of 0.45 μm, the mixture is concentrated to obtain the raw oyster extract.

[0136] The method for extracting longan pulp is as follows: Longan pulp is decocted with 8 times and 6 times the amount of water for 2 hours respectively, the filtrates are combined, and the extract is concentrated under reduced pressure at a vacuum of 0.10 MPa and a temperature of 65°C to obtain longan pulp extract, which is then refrigerated for later use.

[0137] The extraction method for roses is as follows: supercritical CO2 extraction is used, ethanol is added to rose powder as an entrainer, the amount of the entrainer is 15% of the weight of the rose, the extraction pressure is set to 40 MPa, the extraction temperature is set to 55℃, the extraction is carried out for 5 hours, and the CO2 flow rate is controlled at 25 L / h. After the extraction is completed, the extract is collected in a separation vessel to obtain rose extract.

[0138] It also includes the extraction of Poria cocos and licorice: Poria cocos and licorice are mixed and decocted with 8 times and 6 times the amount of water respectively for 1-2 hours. The filtrates are combined, and papain and cellulase are added to the filtrate for enzymatic hydrolysis. The amount of enzyme added is 2% of the total mass of Poria cocos and licorice. The temperature is adjusted to 55℃ and the pH to 6.5. The mixture is stirred and hydrolyzed for 40 minutes. After enzymatic hydrolysis, the mixture is filtered, and ethanol is added to the filtrate for reflux extraction for 1.5 hours. Finally, the mixture is concentrated under reduced pressure to obtain the Poria cocos and licorice extract.

[0139] S3. Mixing and Concentration: Mix all the extracts obtained in step S2 evenly, place them in a vacuum concentrator, and continue to concentrate until the relative density is 1.10 to obtain a mixed concentrate;

[0140] S4. Material Forming: The concentrated liquid obtained in step S3 is mixed with some or all of the food-grade excipients, and the sleep-aiding solid food is obtained through a forming process.

[0141] When the sleep-aid solid food is a solid beverage, the food-grade excipients include at least two of the following: carrier, flavoring agent, filler, and lubricant, and the preparation method includes:

[0142] S4.1. Spray drying: The mixed concentrate obtained in step S3 is added to maltodextrin as a carrier and stirred at 100 r / min for 15 min to dissolve. Then, spray drying is carried out under the conditions of inlet air temperature of 180℃, outlet air temperature of 80℃, feed rate of 20 mL / min and atomization pressure of 0.3 MPa. The extract powder is obtained by passing it through an 80-mesh sieve.

[0143] S4.2. Mixing and granulation: The extract powder is mixed evenly with filler and flavoring agent, and binder is added to form a soft material. Granulation is carried out under the following conditions: extrusion pressure 5 MPa, side sealing pressure < 3 MPa, extrusion speed ≤ 35 rad / min, feeding speed ≤ 64 rad / min, granulation speed 120 rad / min, and cooling temperature control ≤ 15℃.

[0144] S4.3. Drying and granulation: After drying the wet granules at 65℃ for 1-3 hours, granulate them, add lubricant and mix evenly for 7 minutes, then pass through a 12-mesh sieve;

[0145] S4.4. Vacuum packaging: Aluminum foil composite bags are used, and the bags are sealed for 3 seconds under a vacuum of 0.09MPa and a sealing temperature of 120℃, with each bag containing 5g.

[0146] The food-grade excipients, by weight, include: 35 parts maltodextrin, 12 parts microcrystalline cellulose, 5-10 parts fructooligosaccharides, 0.5 parts steviol glycosides, 0.8 parts magnesium stearate, and 0.3 parts sodium citrate.

[0147] When the sleep-aid solid food is a gel candy, the food-grade excipients include gelling agents, sugars, grain flour, edible oils, and purified water, and its preparation method includes:

[0148] S4.1. Preparation of auxiliary materials:

[0149] a. Preparation of gelatin solution: Mix agar and water at a mass ratio of 1:25, heat at 95°C for 3 minutes to dissolve, and then filter to obtain agar filtrate; mix the agar filtrate with an edible gelatin aqueous solution at a mass ratio of 1:2 to obtain an agar-gelatin mixture;

[0150] b. Preparation of syrup: Mix honey, glucose, maltose, water and salad oil in a mass ratio of 30:11:11:20:10, boil to 120℃ and keep warm for 30 minutes, then cool to 15℃ for later use;

[0151] c. Preparation of grain paste: Mix refined grain flour with water at a mass ratio of 1:5, heat to 120℃ and keep warm for later use;

[0152] S4.2. Mixed preparation:

[0153] a. Mix the concentrated liquid obtained in step S3 with the syrup at a mass ratio of 1:25, let stand, and obtain the herbal syrup;

[0154] b. Mix the agar-gelatin mixture with the grain paste at a mass ratio of 2:6 to obtain a mixture; the raw materials of the grain paste include at least one of starch, glutinous rice flour, and sorghum flour;

[0155] S4.3. Shaping and drying: Mix the herbal syrup with the mixture evenly, cool to 15°C and keep warm for 90 minutes, then slice and dry at 50°C for 40 minutes to obtain soft candy;

[0156] S4.4. Packaging: Individual aluminum foil bags are used, with a heat-sealing temperature of 115℃ and a heat-sealing time of 3 seconds.

[0157] The food-grade auxiliary materials, by weight, include: 3 parts agar, 20 parts edible gelatin, 30 parts honey, 11 parts glucose, 11 parts maltose, 10 parts salad oil, 25 parts grain flour, and 120 parts purified water.

[0158] When the sleep-aid solid food is a compressed candy, the food-grade excipients include fillers, sweeteners, and lubricants, and its preparation method includes:

[0159] S4.1. Mixing: The extract powder obtained by spray drying the extract obtained in step S3 is mixed with fructooligosaccharides and microcrystalline cellulose for 35 min, then xylitol is added and mixed for 20 min, and finally magnesium stearate is added and mixed for 7 min to obtain total mixed particles.

[0160] S4.2. Tableting: The total mixed particles are compressed into tablets under a pressure of 20kN;

[0161] S4.3. Packaging: The tablets are packaged in aluminum-plastic blister packs, and the heat sealing temperature is 135℃ and the heat sealing time is 3s.

[0162] The food-grade excipients, by weight, include: 15 parts fructooligosaccharides, 20 parts microcrystalline cellulose, 25 parts xylitol, and 1.5 parts magnesium stearate.

[0163] The effective ingredient content of the sleep-aid solid food of the present invention is: jujube seed saponin ≥1.0mg / g or ≥1.0mg / single dose, ferulic acid ≥0.6mg / g or ≥0.6mg / single dose.

[0164] Experiment Example 1: Determination of the Content of Main Active Ingredients

[0165] 1. Experimental objective:

[0166] The contents of the core active ingredients, jujuboside A, jujuboside B, and ferulic acid, in the sleep-aid solid food prepared according to the present invention patent (Example 2, Solid Beverage Formula and Process) were quantitatively determined. By comparing the product of the present invention with commercially available ordinary raw material powder and verifying whether it meets the minimum standards set by the present invention, the superiority and effectiveness of the compound extraction process of the present invention in enriching active ingredients are demonstrated.

[0167] 2. Materials and Instruments:

[0168] 2.1 Sample:

[0169] Test sample: Sleep-aid solid beverage powder prepared according to Example 2 of the present invention, after sampling, was equilibrated in a desiccator for 24 hours.

[0170] Reference standard: Commercially available common jujube kernels were ground through an 80-mesh sieve using the same grinder to obtain jujube kernel powder.

[0171] Reference reagents: Jujuboside A standard (purity ≥98%), jujuboside B standard (purity ≥98%), and ferulic acid standard (purity ≥99%) were all purchased from the China National Institutes for Food and Drug Control.

[0172] Reagents: Acetonitrile (chromatographic grade), methanol (chromatographic grade), phosphoric acid (analytical grade), ultrapure water.

[0173] Instruments: High-performance liquid chromatograph (Agilent 1260 Infinity II), equipped with a quaternary pump, autosampler, column oven and diode array detector (DAD); analytical balance (METTLER TOLEDO, accuracy 0.0001g); ultrasonic cleaner (KQ-500DE, power 500W); high-speed centrifuge (centrifugal force ≥12000×g); 0.22μm microporous filter membrane (aqueous and organic).

[0174] 3. Experimental methods and procedures:

[0175] 3.1 Chromatographic conditions:

[0176] Chromatographic column: Agilent ZORBAX SB-C18 column (4.6 mm × 250 mm, 5 μm).

[0177] Mobile phase:

[0178] Phase A: 0.1% phosphoric acid aqueous solution; Phase B: acetonitrile.

[0179] Gradient elution procedure:

[0180]

[0181] Flow rate: 1.0 mL / min; Column temperature: 30℃;

[0182] Detection wavelength: Switch wavelength detection. 0-22 min, 203 nm (detection of jujuboside A and B); 22-40 min, 320 nm (detection of ferulic acid).

[0183] Injection volume: 10 μL.

[0184] 3.2 Preparation of the reference solution:

[0185] Accurately weigh approximately 5.0 mg each of jujuboside A, jujuboside B, and ferulic acid standards, and place them separately in 10 mL brown volumetric flasks. Dissolve each separately in methanol and dilute to the mark. Shake well to prepare single standard stock solutions with a concentration of approximately 0.5 mg / mL. Accurately pipette appropriate amounts of each stock solution and dilute with methanol to prepare mixed reference solutions containing 20 μg / mL jujuboside A, 30 μg / mL jujuboside B, and 15 μg / mL ferulic acid. Filter the solution through a 0.22 μm organic filter membrane for later use.

[0186] 3.3 Preparation of the test solution:

[0187] Test solution for the product of this invention: Accurately weigh 0.5 g (accurate to 0.0001 g) of the solid beverage powder of this invention and place it in a 50 mL stoppered conical flask. Accurately add 25 mL of 70% methanol aqueous solution, seal tightly, and weigh. Sonicate (500 W power, 40 kHz frequency) for 45 minutes, cool, and replenish the lost weight with 70% methanol, then shake well. Take an appropriate amount of solution into a centrifuge tube, centrifuge at 12000 rpm for 10 minutes, and filter the supernatant through a 0.22 μm organic filter membrane to obtain the product.

[0188] Commercially available jujube seed powder test solution: Accurately weigh 0.5g of commercially available jujube seed powder and prepare it using the same method.

[0189] 3.4 Determination Method:

[0190] Accurately pipette 10 μL each of the mixed reference solution and the two test solutions into the high-performance liquid chromatograph (HPLC), and perform analysis under the chromatographic conditions described above. Use the external standard method to calculate the content of each component in the test sample based on the peak area of ​​the reference standard. Perform each sample in triplicate.

[0191] 4. Experimental Data and Results:

[0192] 4.1 Methodological Validation:

[0193] Under the chromatographic conditions described, the three target components showed good separation (all >1.5), and the theoretical plate number was greater than 5000. The linear relationship was good (r² > 0.999), and the RSDs for precision, repeatability, and stability were all less than 2.0%. The average recoveries ranged from 98.5% to 101.2%, indicating that the method is accurate and reliable.

[0194] 4.2 Content determination results:

[0195] The average results of the content determination of the target active ingredient in the two samples are shown in the table below:

[0196] Table 1.1: Results of the determination of the content of major active ingredients (n=3)

[0197]

[0198] Note: Data are expressed as mean ± standard deviation; "Not detected" indicates that the content is below the limit of detection (LOD, ferulic acid is 0.01 mg / g). The content of a single dose is calculated based on the product specification of this invention, 5g / bag.

[0199] 5. Experimental Conclusion:

[0200] Based on the experimental data in Table 1.1, the following clear conclusions can be drawn:

[0201] 5.1 The process of this invention significantly enriches the active ingredients:

[0202] Regarding jujube seed saponins: The total jujube seed saponin (A+B) content in the product of this invention is as high as 1.13 mg / g, which not only far exceeds the minimum standard required by this invention (≥1.0 mg / g), but is also 4.2 times that of commercially available ordinary jujube seed powder (0.27 mg / g). This directly proves the high efficiency of the combined process of "water decoction and ethanol microwave-assisted extraction" used in this invention. Traditional water decoction can extract water-soluble components, while subsequent ethanol microwave extraction of the residue can effectively dissolve more fat-soluble saponin components. The rapid heating and molecular stirring effect of microwaves greatly improve the extraction efficiency and yield.

[0203] 5.2 This invention achieves synergistic extraction and retention of multiple components:

[0204] Regarding ferulic acid: The ferulic acid content in the product of this invention is 0.75 mg / g, which is significantly higher than the standard of this invention (≥0.6 mg / g). Ferulic acid was not detected in commercially available jujube seed powder. Ferulic acid is an important phenolic acid active ingredient in jujube seeds, but its content is relatively low and unstable. The successful detection and attainment of the standard content in this invention indicates that the entire process system has a good protective and enriching effect on this type of component. This is due to the application of mild process conditions such as low-temperature vacuum concentration.

[0205] 5.3 The single-dose dosage of the product meets the efficacy design requirements:

[0206] Converted to the smallest dosing unit (5g / sachet), each sachet of the product of this invention provides 5.65mg of total saponins and 3.75mg of ferulic acid. This dosage level is far higher than the single-dose standard specified in this invention (≥1.0mg / single dose, ≥0.6mg / single dose), providing a solid material basis for the product to exert a clear sleep-aiding effect and ensuring the functional reliability of the product.

[0207] Experiment Example 2: Sedative-Hypnotic Effect Experiment in Mice (Verifying Efficacy)

[0208] 1. Experimental objective:

[0209] Through standardized animal behavioral experiments, the sedative effect of the sleep-aiding solid beverage of this invention on the central nervous system, its ability to promote sleep onset, and its effect on prolonging sleep time were objectively evaluated, thereby verifying its overall sleep-aiding efficacy.

[0210] 2. Materials and Animals:

[0211] Test sample: Sleep-aid solid beverage powder prepared according to Example 2 of the present invention. Before use, it was prepared into a suspension of the required concentration using a 0.5% sodium carboxymethyl cellulose (CMC-Na) solution.

[0212] Positive control drug: diazepam tablets, ground and then prepared into a 0.1 mg / mL suspension with 0.5% CMC-Na solution.

[0213] Reagents: sodium pentobarbital, 0.5% CMC-Na solution, physiological saline.

[0214] instrument:

[0215] Mouse spontaneous activity tester (consisting of 4 independent infrared sensing activity boxes, connected to the data analysis system), electronic balance, syringe, and timer.

[0216] Animals: Sixty healthy male ICR mice, weighing 18-22g, SPF grade. Animals were acclimatized for 3 days in an animal room with a temperature of (23±2)℃, humidity of (55±10)%, and a 12 / 12-hour light / dark cycle before being used in the experiment. All procedures were performed in accordance with animal welfare and ethical guidelines.

[0217] 3. Experimental methods and procedures:

[0218] 3.1 Grouping and Dosing:

[0219] Sixty mice were randomly divided into five groups of 12 each.

[0220] Blank control group: The same volume of 0.5% CMC-Na solution was administered by gavage.

[0221] Positive control group: Diazepam 1 mg / kg body weight was administered by gavage (0.1 mL / 10 g).

[0222] The low-dose group of the product of this invention is administered by gavage at a dose of 2.5 g / kg body weight (equivalent to 2.5 times the clinically equivalent dose for adults).

[0223] The dosage group of the product of this invention is: 5.0 g / kg body weight administered by gavage (equivalent to 5 times the clinically equivalent dose for adults).

[0224] The high-dose group of the product of this invention is administered by gavage at a dose of 10.0 g / kg body weight (equivalent to 10 times the clinically equivalent dose for adults).

[0225] All groups were administered the drug via gavage at a volume of 0.1 mL / 10 g, once daily for 7 consecutive days. The following behavioral tests were performed 30 minutes after the last administration on day 7.

[0226] 3.2 Autonomous Activity Experiment:

[0227] Thirty minutes after the last administration, mice from each group were placed one by one into the spontaneous activity testing chamber. After the mice were allowed to acclimatize for one minute, the system automatically recorded the total number of activities (number of times they crossed the infrared beam) over the following 10 minutes. The testing chamber was thoroughly cleaned after each mouse was tested to avoid odor interference.

[0228] 3.3 Synergistic effect of subthreshold dose of sodium pentobarbital during sleep:

[0229] After completing the spontaneous activity test, mice in each group were immediately injected intraperitoneally with sodium pentobarbital (30 mg / kg). Following injection, the mice were placed in cages lined with clean bedding for individual observation. The number of mice falling asleep within 15 minutes was recorded. The criterion for falling asleep was the absence of the righting reflex for more than 60 seconds. The sleep rate for each group was calculated as (number of sleeping animals / total number of animals in the group × 100%).

[0230] 3.4 Synergistic Experiment on Sleep Duration with Suprathreshold Pentobarbital Sodium

[0231] To ensure experimental reliability, a separate batch of mice (n=12 / group) with the same grouping and administration method was selected the day after the spontaneous activity experiment. Thirty minutes after the last administration, each group of mice was intraperitoneally injected with sodium pentobarbital (45 mg / kg). The following data were recorded for each mouse:

[0232] 1. Sleep latency: The time from the completion of injection to the disappearance of the righting reflex.

[0233] 2. Sleep duration: The time from the disappearance of the righting reflex to the first restoration of the righting reflex.

[0234] 4. Experimental Data and Results:

[0235] 4.1 Effects on spontaneous activity in mice:

[0236] Table 2.1: Effects on spontaneous activity in mice (x±s, n=12)

[0237]

[0238] Note: Compared with the blank control group, P<0.05, *P<0.01.

[0239] As shown in Table 2.1, compared with the blank control group, the positive control drug diazepam significantly inhibited spontaneous activity in mice (P<0.01). The medium and high dose groups of the product of this invention also significantly reduced the number of spontaneous activities in mice (P<0.05, P<0.01), and showed a certain dose-dependent effect, indicating that the product has a clear central sedative effect.

[0240] 4.2 Effects of subthreshold doses of sodium pentobarbital on sleep induction:

[0241] Table 2.2: Effect of subthreshold doses of sodium pentobarbital on sleep experiments (n=12)

[0242]

[0243] Note: Compared with the blank control group, P<0.05, *P<0.01 (chi-square test).

[0244] As shown in Table 2.2, only a few mice in the blank control group fell asleep under the influence of subthreshold doses of sodium pentobarbital (sleep onset rate 16.7%). The sleep onset rate in the positive control group reached 100%. All dosage groups of the product of this invention can significantly improve the sleep onset rate, and the sleep onset rate of the high-dose group (83.3%) is not statistically different from that of the positive control group, showing a significant synergistic sleep-inducing effect.

[0245] 4.3 Effects of suprathreshold doses of sodium pentobarbital on sleep induction:

[0246] Table 2.3: Effect of suprathreshold doses of sodium pentobarbital on sleep duration (x±s, n=12)

[0247]

[0248] Note: Compared with the blank control group, P<0.05, *P<0.01.

[0249] As shown in Table 2.3, the medium and high dose groups of the product of this invention significantly shortened the sleep latency (P<0.05) and significantly prolonged the sleep duration (P<0.01). The high dose group showed a particularly outstanding effect in prolonging sleep time, exceeding the blank control group by nearly double.

[0250] 5. Experimental Conclusion:

[0251] Based on the results of the above three experiments, the following conclusions can be drawn:

[0252] 5.1 Clear sedative effect: Data from the spontaneous activity experiment (Table 2.1) show that the medium and high dose groups of the product of this invention can significantly reduce the number of spontaneous activities in mice, proving that the active ingredients in the product (such as jujube seed saponins, ferulic acid, etc.) can act on the central nervous system, reduce its excitability, and produce a sedative effect similar to "calming the mind and calming the nerves", thus creating conditions for subsequent sleep promotion.

[0253] 5.2 Effectively promotes sleep onset: Subthreshold dose sleep experiment data (Table 2.2) show that the product of this invention can significantly improve the sleep onset rate of mice at subthreshold hypnotic doses in a dose-dependent manner. In particular, the high-dose group, its sleep-promoting effect (83.3%) is close to that of the potent positive control drug diazepam (100%). This verifies the product's efficacy in shortening sleep onset time.

[0254] 5.3 Significantly Extends Sleep Duration: Data from suprathreshold dose sleep experiments (Table 2.3) show that the medium and high dose groups of the product of this invention not only shorten the time required to fall asleep (latency period), but also significantly extend the total sleep duration. The high dose group extended sleep time from 48.3 minutes in the control group to 85.8 minutes, an increase of 77.6%. This demonstrates the product's potential to improve sleep quality and prolong deep sleep.

[0255] Experiment Example 3: Product Stability and Sensory Evaluation Experiment

[0256] 1. Experimental objective:

[0257] The physical, chemical, and microbiological stability of the sleep aid candy of this invention under simulated harsh storage conditions was evaluated through accelerated stability testing. At the same time, its appearance, flavor, taste, and overall acceptability were objectively evaluated through consumer sensory evaluation, thereby comprehensively verifying the reliability and market potential of the product.

[0258] 2. Materials and Methods:

[0259] 2.1 Test Sample:

[0260] Three batches of sleep-aid candies were prepared according to the formula and process of Example 2 of this invention.

[0261] Each batch of samples was produced under the same production conditions and packaged individually in aluminum foil bags (approximately 5g per bag, containing 2 candies).

[0262] 2.2 Accelerated stability test:

[0263] 2.2.1 Test conditions: In accordance with the ICH Q1A(R2) guidelines, the unopened sample was placed in a constant temperature and humidity test chamber (Binder KBF 720) with the conditions set at 40℃±2℃ and relative humidity of 75%±5%.

[0264] 2.2.2 Sampling time points: the initial (month 0), and the end of the 1st, 2nd, and 3rd months.

[0265] 2.2.3 Evaluation Indicators and Methods:

[0266] 1. Appearance and color: Under a standard light source box, three trained observers visually inspect and record any signs of adhesion, deformation, melting, water separation, color changes, or mold.

[0267] 2. Texture (Hardness): A physical property analyzer (TA.XT Plus) equipped with a P / 2 probe was used. Test conditions: pre-test speed 1.0 mm / s, test speed 2.0 mm / s, post-test speed 10.0 mm / s, trigger force 5.0 g, compression deformation 30%. The peak force (g) during compression was recorded as the hardness indicator. Each sample was tested in parallel 6 times.

[0268] 3. Water activity (Aw): Measured directly at 25°C using a water activity meter (AQUALAB 4TE). Aw is a key parameter for predicting microbial growth and physical stability.

[0269] 4. Content of key active ingredients: Referring to the HPLC method in Experiment Example 1, the contents of total saponins and ferulic acid in the sample were determined, and the retention rate (%) relative to the sample in month 0 was calculated.

[0270] 5. Microbial limits: The total bacterial count, coliform bacteria, mold and yeast counts were determined according to the method in the National Food Safety Standard for Candy (GB17399).

[0271] 2.3 Sensory evaluation:

[0272] Evaluation Panel: 108 healthy volunteers (aged 25-55, half male and half female) with mild sleep disturbances were publicly recruited. All participants had no history of food allergies and provided informed consent for the experiment.

[0273] Evaluation Method: A double-blind, single-exposure test was used. Three batches of samples were mixed and numbered, and each participant was randomly assigned an individually packaged sample (approximately 5g). Evaluations were conducted in a separate sensory evaluation compartment using a pre-designed electronic questionnaire.

[0274] Evaluation Dimensions and Standards: A 9-point preference scale (1 = extremely dislike, 5 = neither dislike nor hate, 9 = extremely like) is used to score the following attributes:

[0275] 1. Appearance appeal: color uniformity, gloss, and shape regularity.

[0276] 2. Scent preference: Scent intensity, pleasantness, and whether it has an unpleasant medicinal or strange smell.

[0277] 3. Texture preference: softness / hardness, elasticity, chewiness, and stickiness.

[0278] 4. Flavor preference: sweetness, acidity, flavor intensity, aftertaste, and degree of masking of herbal notes.

[0279] 5. Overall Acceptability: The overall level of liking based on all the above aspects.

[0280] 3. Experimental Data and Results:

[0281] 3.1 Accelerated stability test results:

[0282] Table 3.1: Changes in key indicators of accelerated stability test of sleep aid gel candies (mean ± standard deviation of three batches)

[0283]

[0284] Note: All microbiological indicators meet the requirements of GB17399.

[0285] 3.2 Sensory evaluation results

[0286] A total of 105 valid questionnaires were collected. The average preference scores for each sensory attribute are as follows:

[0287] Table 3.2: Sensory Evaluation Preference Scores of Sleep Aid Gel Candies (n=105)

[0288]

[0289] feedback:

[0290] More than 85% of the participants specifically noted that "the bitterness of the herbs was barely perceptible."

[0291] About 80% of the participants thought that "the sweet and sour ratio was just right and not cloying".

[0292] 4. Experimental Conclusion:

[0293] Based on the specific data in Tables 3.1 and 3.2, the following conclusions can be drawn:

[0294] 4.1 Excellent physical and chemical stability:

[0295] Texture stability: In a 3-month accelerated test, the candy hardness increased only slightly (from 1250g to 1320g, a change of 5.6%), well below the common acceptance limit of 20%. This demonstrates that the agar-gelatin composite gelling system has a good synergistic effect with specific syrup formulations (honey, maltose, etc.), effectively locking in water and maintaining the gel network structure, preventing it from becoming sticky, soft, or hard under high temperature and humidity.

[0296] Excellent water activity control: The Aw value remained consistently below 0.64 throughout the process. This key data (<0.65) not only effectively inhibits the growth of most bacteria, molds, and yeasts (confirmed by microbiological data), but also explains why the product has no water separation or mold growth, and is the core guarantee for the product's stable shelf life.

[0297] High retention of active ingredients: Even under harsh accelerated conditions, the retention rates of the core active ingredients, total saponins from jujube seed and ferulic acid, remain above 95%. This demonstrates that the gentle mixing and concentration process of this invention, as well as the molding process (such as encapsulation), effectively protects the heat-sensitive active substances.

[0298] 4.2 Excellent sensory acceptance:

[0299] High rating performance: The average score of all sensory attributes is above 7.8, and the overall acceptance rate is 8.0, which is clearly in the range of "like" to "very like".

[0300] Successfully masking unpleasant flavors: Over 85% of participants did not perceive any unpleasant herbal taste, thanks to a multi-layered flavor-correcting system: supercritical CO2 extract of rose provides a naturally pleasant floral top note; longan pulp and syrup (honey, maltose) contribute a full-bodied sweetness and aftertaste; acidulants such as sodium citrate balance the sweetness. This complex flavor design successfully masks the inherent slight astringency and bitterness of ingredients such as jujube seed and poria cocos.

[0301] Experiment Example 4: Comparative Experiment with Commercially Available Single-Ingredient Sleep Aid Supplements:

[0302] This experiment, using a rigorous animal model, directly compares the effects, strength, and multi-target regulatory advantages of the compound formula product of this invention with those of mainstream single-ingredient sleep aids (represented by melatonin and γ-aminobutyric acid / GABA) on improving insomnia, thereby verifying the scientific value of this invention in "multi-component, multi-pathway, and holistic regulation".

[0303] 1. Experimental objective:

[0304] 1.1 The sleep-promoting effects of the product of this invention, single-component melatonin, and single-component GABA products were compared in a recognized rat model of insomnia.

[0305] 1.2 The differences in the mechanisms of action of different products were comprehensively evaluated from three levels: behavioral science, neurotransmitter levels in key brain regions, and EEG structure during sleep.

[0306] 1.3 Verification of the advantages of the product of this invention through compound formulation: "sedation, sleep promotion and regulation of neurotransmitter network balance".

[0307] 2. Materials and Animals:

[0308] Test sample:

[0309] Product group of this invention: Sleep-aid solid beverage powder prepared according to Example 2 of this invention. A suspension is prepared using a 0.5% sodium carboxymethyl cellulose (CMC-Na) solution.

[0310] Melatonin control group: Commercially available melatonin tablets (3 mg per tablet) were purchased, ground, and prepared into a suspension of 0.3 mg / mL using 0.5% CMC-Na solution (rats were given a dose equivalent to the adult dose).

[0311] GABA control group: Commercially available high-purity GABA powder (purity ≥99%) was used to prepare a 50 mg / mL suspension with 0.5% CMC-Na solution (set according to the recommended dose of mainstream products and the animal equivalent dose).

[0312] Model control group: given an equal volume of 0.5% CMC-Na solution.

[0313] Normal control group: Normal rats that have not undergone modeling were given an equal volume of 0.5% CMC-Na solution.

[0314] Modeling reagent: p-chlorophenylalanine (PCPA), prepared as a suspension with physiological saline.

[0315] Test reagents: sodium pentobarbital, paraformaldehyde, physiological saline, and ELISA kit for related neurotransmitters (5-HT, DA, GABA).

[0316] Laboratory animals: 70 healthy male SD rats, weighing 180-220g, SPF grade. Purchased from Spiefolk (Beijing) Biotechnology Co., Ltd.

[0317] Main instruments: rat open field test chamber (100cm×100cm×40cm), small animal anesthesia machine and EEG / EMG recording system, refrigerated centrifuge, ELISA reader, precision electronic balance.

[0318] 3. Experimental methods and procedures:

[0319] 3.1 Establishment and grouping of the insomnia rat model:

[0320] Seventy rats were acclimatized in a standard environment for one week and then randomly divided into five groups (n=14): normal control group, model control group, product group of this invention, melatonin group, and GABA group.

[0321] Except for the normal control group, the other four groups of rats were intraperitoneally injected with PCPA (300 mg / kg / d) for two consecutive days to deplete 5-hydroxytryptamine (5-HT) in the brain, thus establishing a rat model of chemical insomnia. After modeling, the success of the model was preliminarily verified by the open field test (the spontaneous activity of rats in the model group should be significantly increased).

[0322] 3.2 Drug administration intervention:

[0323] The day after successful modeling, medication was administered via gavage once daily for seven consecutive days.

[0324] The product group of this invention is administered by gavage at a dose of 2.0 g / kg (equivalent to the clinically recommended adult dose).

[0325] Melatonin group: 3 mg / kg was administered by gavage.

[0326] GABA group: 500 mg / kg was administered by gavage.

[0327] Model group and normal group: The same volume of 0.5% CMC-Na solution was administered by gavage.

[0328] 3.3 Behavioral evaluation (open field test):

[0329] Thirty minutes after the last administration, rats in each group were placed individually in an open field test chamber. The total distance traveled and the time spent in the central region were recorded over 5 minutes. The total distance traveled reflects overall excitability, while the time spent in the central region reflects anxiety.

[0330] 3.4 Neurochemical marker detection:

[0331] Following behavioral testing, six rats were randomly selected from each group and anesthetized by intraperitoneal injection of sodium pentobarbital (40 mg / kg). The rats were then rapidly decapitated, and the brain was removed. Hypothalamic tissue (the sleep regulation center) was isolated on an ice plate. Approximately 50 mg of tissue was accurately weighed, homogenized in pre-cooled physiological saline, centrifuged, and the supernatant was collected. The levels of 5-hydroxytryptamine (5-HT), dopamine (DA), and gamma-aminobutyric acid (GABA) were determined according to the instructions of the ELISA kit.

[0332] 3.5 Sleep EEG Recording and Analysis:

[0333] Before the experiment began, the remaining 8 rats in each group underwent aseptic surgery to implant recording electrodes at specific locations on the surface of their skulls (3.5 mm anterior to the anterior fontanelle and 2.0 mm lateral to the midline; 6.0 mm posterior to the anterior fontanelle and 3.0 mm lateral to the midline) for recording electrocorticography (EEG); simultaneously, electrodes were implanted in the neck and back muscles to record electromyography (EMG). The rats recovered for 7 days post-surgery.

[0334] On days 6 and 7 of the drug intervention, EEG / EMG signals were continuously recorded for 12 hours (from 8:00 PM to 8:00 AM) while the animals were in a natural sleep state. Total sleep time (TST), non-rapid eye movement sleep (NREMS) time, and the proportion of slow-wave sleep (SWS, i.e., deep sleep) in NREMS were analyzed using specialized software.

[0335] 4. Experimental Data and Results:

[0336] 4.1 Behavioral Analysis: The Impact on Open Field Activities

[0337] Table 4.1: Comparison of open field behavior in rats among different groups (x±s, n=8)

[0338]

[0339] Note: Compared with the model control group, P<0.05, P<0.01; compared with the normal control group, #P<0.05, ##P<0.01.

[0340] As shown in Table 4.1, after PCPA modeling, the total movement distance of rats in the model group increased significantly (P<0.01), and the central zone dwell time decreased significantly (P<0.05), indicating that the insomnia-anxiety model was successfully established. Compared with the model group, all intervention groups reduced the excessive activity of rats. Among them, the product group and the melatonin group showed the most significant effects in reducing the total movement distance (P<0.01), and the product group significantly increased the central zone dwell time (P<0.05), suggesting that it also has an anti-anxiety effect. The GABA group had a relatively mild inhibitory effect on spontaneous activity.

[0341] 4.2 Neurobiochemistry: Regulation of the hypothalamic neurotransmitter network

[0342] Table 4.2: Comparison of hypothalamic neurotransmitter content in different groups of rats (x±s, n=6)

[0343]

[0344] Note: Compared with the model control group, P<0.05, P<0.01; compared with the normal control group, #P<0.05, ##P<0.01.

[0345] As shown in Table 4.2, PCPA modeling successfully depleted the hypothalamic 5-HT content (P<0.01), leading to a compensatory increase in DA content (P<0.05) and a decrease in GABA content.

[0346] The melatonin group primarily showed a significant increase in 5-HT levels (P<0.01), with no significant regulatory effect on DA and GABA. This is consistent with the fact that melatonin, as an endogenous sleep signaling molecule, has a synthesis dependent on the 5-HT pathway.

[0347] GABA group: As expected, it significantly increased the amount of GABA in the brain (P<0.01), but had no corrective effect on the abnormalities of 5-HT and DA.

[0348] The product group of this invention exhibits a unique advantage in comprehensively regulating the neurotransmitter network. It significantly increases the levels of 5-HT and GABA (P<0.01) while significantly reducing abnormally elevated DA levels (P<0.05), bringing the ratio of the three key neurotransmitters closer to that of the normal control group. This demonstrates the synergistic effect of the compound formula's ingredients, such as jujube seed, poria cocos, longan pulp, and ginseng, through different pathways.

[0349] 4.3 Sleep EEG: Its Influence on Sleep Structure

[0350] Table 3: Structural analysis of EEG during sleep in each group of rats (x±s, n=8)

[0351]

[0352] Note: Compared with the model control group, P<0.05, P<0.01; compared with the normal control group, #P<0.05, ##P<0.01.

[0353] As shown in Table 4.3, the total sleep time and the proportion of slow-wave sleep in the model group rats were significantly lower than those in the normal group (P<0.01).

[0354] Both the melatonin group and the GABA group significantly increased total sleep time (P<0.05), mainly by prolonging NREMS time.

[0355] While significantly extending total sleep time (P<0.01), the core advantage of this invention lies in its extremely significant increase in the proportion of slow-wave sleep (SWS) (P<0.01). SWS is the most important restorative stage of sleep, closely related to clearing metabolic waste from the brain, consolidating memory, and restoring physical strength. This result suggests that the product of this invention can not only promote sleep onset and prolong sleep, but also improve sleep depth and quality.

[0356] 5. Experimental Conclusions

[0357] Based on the data from the above three parts, the following clear conclusions can be drawn:

[0358] 5.1 The product of this invention has a sleep-inducing strength comparable to mainstream single-ingredient products: In terms of behavioral (inhibition of excessive activity) and prolongation of total sleep time, the product of this invention shows similar or even better efficacy than melatonin and GABA (Tables 4.1 and 4.3), proving its solid foundation as an effective sleep aid.

[0359] 5.2 The product of this invention, through compound formulation, can simultaneously and positively regulate the neurotransmitter triangle closely related to the sleep-wake cycle, including 5-HT (increase), DA (decrease), and GABA (increase).

[0360] 5.3 The sleep EEG data of the product of this invention (Table 4.3) show that the product of this invention significantly increases the proportion of deep slow-wave sleep (SWS) while effectively prolonging sleep time. This directly corresponds to higher sleep repair efficiency and better morning recovery, solving the common pain point of not feeling refreshed after sleep. In contrast, single-component melatonin and GABA show limited improvement in this indicator.

[0361] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any person skilled in the art can easily conceive of various variations or substitutions within the technical scope disclosed in the present invention, and these should all be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A sleep-aiding solid food based on a complex formula of Zizyphus jujuba, characterized in that, According to the weight parts, the following raw material components are included: 20-40 parts of Chinese date kernel, 15-25 parts of longan meat, 25-35 parts of raw oyster, 10-20 parts of poria, 4-8 parts of licorice, 1-3 parts of ginseng, 3-7 parts of rose, and food-grade auxiliary materials; The preparation method of the sleep-aiding solid food comprises the following steps: S1. Raw material pretreatment: crush the Chinese date kernel, longan meat, poria, licorice, and rose separately to pass through a 20-mesh sieve, crush the raw oyster to pass through an 80-mesh sieve, and vacuum freeze-dry the ginseng and then ultra-micro-powder it to a particle size of ≤10 μm; S2. Compound extraction: extract the core raw materials respectively to obtain extracts or extract solutions, at least including: water decocting and ethanol microwave extraction of Chinese date kernel, alkaline protease enzymolysis of raw oyster, water decocting extraction of ginseng, water decocting extraction of longan meat, and supercritical CO2 extraction of rose; S3. Mixing and concentration: mix all the extracts obtained in step S2 uniformly, and continue to concentrate in a reduced pressure concentrator to a relative density of 1.08-1.10 to obtain a mixed concentrated solution; S4. Material forming: mix the mixed concentrated solution obtained in step S3 with part or all of the food-grade auxiliary materials, and prepare the sleep-aiding solid food through a forming process.

2. The sleep-aiding solid food based on a complex recipe of Chinese date kernels according to claim 1, characterized in that, The food-grade auxiliary materials include at least two of carriers, flavoring agents, fillers, and lubricants; the sleep-aiding solid food is a solid beverage, and the S4 step of the preparation method specifically comprises: S4.

1. Spray drying: add malt dextrin as a carrier to the mixed concentrated solution obtained in step S3, stir and dissolve for 5-15 min at 100 r / min, and then perform spray drying under the conditions of an inlet air temperature of 180℃, an outlet air temperature of 80℃, a feeding speed of 20 mL / min, and an atomization pressure of 0.3 MPa, pass through an 80-mesh sieve, and obtain an extract powder; S4.

2. Mixing and granulation: mix the extract powder with fillers and flavoring agents uniformly, add a binder to prepare soft material, and perform granulation under the conditions of an extrusion pressure of 2-5 MPa, a side seal pressure of <3 MPa, an extrusion speed of ≤35 rad / min, a feeding speed of ≤64 rad / min, a granulation speed of 60-120 rad / min, and a cooling temperature control of ≤15℃; S4.

3. Drying and granulating: dry the wet granules at 55-65℃ for 1-3 h, granulate, add a lubricant, mix uniformly for 3-7 min, and pass through a 12-mesh sieve; S4.

4. Vacuum packaging: use an aluminum foil composite bag, seal under the conditions of a vacuum degree of 0.09 MPa and a sealing temperature of 120℃ for 3 s, and fill 3-5 g per bag.

3. The sleep-aiding solid food based on a complex recipe of Chinese date kernels according to claim 2, characterized in that, According to the weight parts, the food-grade auxiliary materials include: 25-35 parts of malt dextrin, 8-12 parts of microcrystalline cellulose, 5-10 parts of fructooligosaccharide, 0.1-0.5 parts of steviol glycoside, 0.3-0.8 parts of magnesium stearate, and 0.1-0.3 parts of sodium citrate.

4. The sleep-aiding solid food based on a complex recipe of Chinese date kernels according to claim 1, characterized in that, The food-grade auxiliary materials include gelling agents, sugars, grain fine powder, edible oil, and purified water; the sleep-aiding solid food is a gel candy, and the S4 step of the preparation method specifically comprises: S4.

1. Auxiliary material preparation: a. preparing a glue solution: mixing agar and water in a mass ratio of 1:(20-25), heating and dissolving at 85-95℃ for 1-3 min, and then filtering to obtain an agar filtrate; mixing the agar filtrate and an edible gelatin aqueous solution in a mass ratio of 1:(1-2) to obtain an agar gelatin mixture; b. preparing a sugar syrup: mixing honey, glucose, sugar candy, water, and salad oil in a mass ratio of (20-30):(9-11):(9-11):(15-20):(5-10), heating to 100-120℃ and keeping for 5-30 min, and then cooling to 10-15℃ for standby; c. preparing a grain paste: mixing grain fine powder and water in a mass ratio of 1:(3-5), heating to 100-120℃ for standby; S4.

2. mixing preparation: a. mixing the mixed concentrate obtained in the S3 step and the sugar syrup in a mass ratio of 1:(15-25), and standing to obtain a Chinese herbal medicine sugar syrup; b. mixing the agar gelatin mixture and the grain paste in a mass ratio of 2:(4-6) and stirring to obtain a mixture; the raw materials of the grain paste include at least one of starch, glutinous rice fine powder, and sorghum fine powder; S4.

3. shaping and drying: uniformly mixing the Chinese herbal medicine sugar syrup and the mixture, cooling to 10-15℃ and keeping for 30-90 min, and then slicing and drying at 40-50℃ for 20-40 min to obtain soft candy; S4.

4. packaging: using an aluminum foil independent bag, and the heat sealing temperature is 105-115℃ and the heat sealing time is 1-3 s.

5. The sleep-aiding solid food based on a complex recipe of Chinese date kernels according to claim 4, characterized in that, The food-grade auxiliary materials include, by weight fraction, agar 1-3 parts, edible gelatin 10-20 parts, honey 20-30 parts, glucose 9-11 parts, sugar candy 9-11 parts, salad oil 5-10 parts, grain fine powder 15-25 parts, and purified water 80-120 parts.

6. The sleep-aiding solid food based on a complex recipe of Chinese date kernels according to claim 2, characterized in that, The food-grade auxiliary materials include a filler, a sweetener, and a lubricant; the sleep-aiding solid food is a compressed tablet candy, and the S4 step of the preparation method specifically includes: S4.

1. mixing: uniformly mixing the extract powder obtained by spray drying the extract obtained in the S3 step, fructooligosaccharide, and microcrystalline cellulose for 25-35 min, then adding xylitol and mixing for 10-20 min, and finally adding magnesium stearate and uniformly mixing for 2-7 min to obtain total mixed granules; S4.

2. tablet compression: compressing the total mixed granules into tablets under a pressure of 16-20 kN; S4.

3. packaging: aluminum plastic blister packaging of the tablets, heat sealing temperature of 125-135℃, and heat sealing time of 1-3 s.

7. The sleep-aiding solid food based on a complex recipe of Chinese date kernels according to claim 2, characterized in that, The food-grade auxiliary materials include, by weight fraction, fructooligosaccharide 8-15 parts, microcrystalline cellulose 10-20 parts, xylitol 15-25 parts, and magnesium stearate 0.5-1.5 parts.

8. The sleep-aiding solid food according to any one of claims 1-7, characterized in that, In the S2 step: The extraction method of the Suanzaoren is as follows: the Suanzaoren is boiled with 8 times and 6 times of water respectively for 1-2 hours, and the filtrates are combined; the residue is soaked with 70-80% ethanol for 110-130 minutes, and then extracted under the conditions of microwave power of 1400-1600 W and temperature of 65-75 ℃ for 20-30 minutes; the combined filtrate is concentrated under the conditions of vacuum degree of 0.06-0.1 MPa and temperature of 50-70 ℃ to a relative density of 1.05, so as to obtain the Suanzaoren extract; The extraction method of the Renshen is as follows: the Renshen is boiled with 8 times and 6 times of water respectively for 1-2 hours, and the filtrates are combined; the combined filtrate is concentrated under the conditions of vacuum degree of 0.06-0.1 MPa and temperature of 50-70 ℃ to a relative density of 1.05, so as to obtain the Renshen extract; The extraction method of the Shengmuo is as follows: the Shengmuo powder is added with 0.3-0.5% alkaline protease, and then enzymolysis is carried out under the conditions of temperature of 45-55 ℃, pH of 7.0-8.0 and stirring speed of 40-60 r / min for 3-5 hours; the filtrate is filtered through a plate-and-frame filter with a filter membrane pore size of 0.45 μm, and then concentrated, so as to obtain the Shengmuo extract; The extraction method of the Longyannu is as follows: the Longyannu is boiled with 8 times and 6 times of water respectively for 1-2 hours, and the filtrates are combined; the combined filtrate is concentrated under the conditions of vacuum degree of 0.06-0.10 MPa and temperature of 55-65 ℃, so as to obtain the Longyannu extract, which is stored in a refrigerator; The extraction method of the Meigui is as follows: the Meigui powder is added with ethanol as a entrainer, and the amount of the entrainer is 5-15% of the weight of the Meigui; the extraction is carried out under the conditions of extraction pressure of 30-40 MPa, extraction temperature of 45-55 ℃ and CO2 flow rate of 15-25 L / h for 3-5 hours; after the extraction is completed, the Meigui extract is collected through a separation kettle.

9. The sleep-aiding solid food based on a complex recipe of Chinese date according to claim 8, characterized in that, In the S2 step, the extraction of Fuling and Gancao is also included: the Fuling and Gancao are mixed, and then boiled with 8 times and 6 times of water respectively for 1-2 hours, and the filtrates are combined; the combined filtrate is added with papain and cellulase for enzymolysis, and the amount of the enzymes is 0.5%-2% of the total mass of the Fuling and Gancao; the temperature is adjusted to 45-55 ℃, and the pH is adjusted to 5.5-6.5; the stirring hydrolysis is carried out for 20-40 minutes; after the enzymolysis, the filtrate is filtered; the filtrate is added with ethanol for refluxing and alcohol extraction for 0.5-1.5 hours; finally, the Fuling and Gancao extract is obtained through vacuum concentration.

10. A sleep-aiding solid food based on a complex recipe of Zizyphus jujuba according to any one of claims 1-7, characterized in that, The effective component content of the sleep-aiding solid food is as follows: Suanzaoren saponin ≥ 1.0 mg / g or ≥ 1.0 mg / single dose, and ferulic acid ≥ 0.6 mg / g or ≥ 0.6 mg / single dose.

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