CN114668148B - Health care composition with effects of soothing nerves and aiding sleep as well as preparation method, health care product and application thereof - Google Patents
Health care composition with effects of soothing nerves and aiding sleep as well as preparation method, health care product and application thereof Download PDFInfo
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- CN114668148B CN114668148B CN202210340555.5A CN202210340555A CN114668148B CN 114668148 B CN114668148 B CN 114668148B CN 202210340555 A CN202210340555 A CN 202210340555A CN 114668148 B CN114668148 B CN 114668148B
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Classifications
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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Abstract
The invention provides a health care composition with the effects of soothing nerves and aiding sleep, a preparation method thereof, a health care product and application thereof, and relates to the technical field of health care products. The health care composition is mainly prepared from raw materials such as peanut stem and leaf extract, aminobutyric acid, theanine, cordyceps militaris extract and the like according to a specific proportion, and has a good effect on sleep and tranquillization through the synergistic interaction of the raw materials, and has great practical significance on improving sleep, relieving fatigue and improving life quality of people. The invention also provides a preparation method of the health care composition, which has simple process and convenient operation and is suitable for industrial mass production.
Description
Technical Field
The invention relates to the technical field of health products, in particular to a health-care composition with the effects of soothing nerves and aiding sleep, a preparation method thereof, a health-care product and application thereof.
Background
In recent years, the country continues to increase the supporting force on the large health industry, and the nutrition and health food industry is gradually gaining attention as an important support of the large health industry. With the rising of the concept of 'large health', the increase of incomes, consumption upgrading and population aging of residents all over the country, the outstanding epidemic situation is superimposed, the health concept of the nations is continuously changed and deepened, and huge health market demands are derived, so that the future space availability in the fields of nutrition and health food industry prospect and subdivision is increased.
With the increase of the life rhythm of people, the working pressure is larger, the sleep quality is continuously reduced, the number of sub-healthy people is increased year by year, the sleep deficiency is more and more younger, and great harm is caused to the body and spirit of people. Therefore, how to improve insomnia and sleep quality is a problem to be solved urgently.
In view of this, the present invention has been made.
Disclosure of Invention
The first aim of the invention is to provide a health care composition with the effects of soothing nerves and aiding sleep.
The second aim of the invention is to provide a preparation method of the health care composition with the effects of soothing nerves and aiding sleep.
The third aim of the invention is to provide a health care product which comprises the health care composition with the effects of soothing nerves and aiding sleep.
The fourth aim of the invention is to provide the application of the health care composition or the health care product with the effects of soothing nerves and aiding sleep.
In order to achieve the above object, the present invention has the following technical scheme:
the invention provides a health care composition with the effects of soothing nerves and aiding sleep, which comprises the following raw materials in parts by weight:
65-85 parts of peanut stem and leaf extract, 6-12 parts of aminobutyric acid, 5-10 parts of theanine and 5-10 parts of cordyceps militaris extract.
Furthermore, on the basis of the technical scheme, the health care composition comprises the following raw materials in parts by weight:
68-80 parts of peanut stem and leaf extract, 8-11 parts of aminobutyric acid, 6.5-10 parts of theanine and 5.5-9 parts of cordyceps militaris extract.
Furthermore, on the basis of the technical scheme, the preparation method of the peanut stem and leaf extract comprises the following steps:
concentrating the extracting solution obtained after extracting the peanut stems and leaves with water, and drying to obtain a crude peanut stem and leaf extract product;
crushing and purifying the crude peanut stem and leaf extract to obtain the peanut stem and leaf extract.
Furthermore, on the basis of the technical scheme, in the preparation method of the peanut stem and leaf extract, the peanut stem and leaf is extracted for 1-3 times by water;
preferably, the temperature of each extraction is respectively and independently 90-95 ℃, and the time of each extraction is respectively and independently 1-2h.
Preferably, the feed liquid ratio of each extraction is 1: (5-10).
Furthermore, on the basis of the technical scheme, in the preparation method of the peanut stem and leaf extract, the extracting solution is concentrated to a specific gravity of 1.1-1.2;
preferably, the drying is spray drying;
preferably, the spray drying temperature is 190-210 ℃;
preferably, the size of the crushed particles is 80-100 mesh.
The invention also provides a preparation method of the health care composition with the effects of soothing nerves and aiding sleep, which comprises the following steps:
mixing the raw materials to obtain the health care composition with the effects of soothing nerves and aiding sleep.
The invention also provides a health product, which comprises the health composition with the effects of soothing nerves and aiding sleep and auxiliary materials.
Furthermore, on the basis of the technical scheme, the auxiliary materials comprise any one or a combination of at least two of a matrix, a suspending agent, a sweetener, a filler, a disintegrating agent, a lubricant and a preservative.
Furthermore, on the basis of the technical scheme, the formulation of the health care product comprises any one of capsules, tablets, pills, granules or oral liquid.
The invention also provides application of the health care composition or the health care product with the effects of soothing the nerves and aiding sleep in the fields of improving sleep and soothing the nerves.
Compared with the prior art, the invention has the following technical effects:
(1) The invention provides a health care composition with the effects of soothing the nerves and aiding sleep, which is mainly prepared from raw materials such as peanut stem and leaf extract, aminobutyric acid, theanine, cordyceps militaris extract and the like according to a specific proportion, and has good sleep soothing effect by the synergistic interaction of the raw materials, and has great practical significance for improving sleep, relieving fatigue and improving life quality of people.
(2) The invention provides a preparation method of the health care composition with the effects of soothing nerves and aiding sleep, which is simple in process, convenient to operate and suitable for industrial mass production.
(3) The invention provides a health care product, which comprises the health care composition with the effects of soothing nerves and aiding sleep. In view of the advantages of the health care composition with the effects of soothing nerves and aiding sleep, the health care product prepared by adopting the composition also has the same advantages.
(4) The invention provides the application of the health care composition or the health care product with the effects of soothing the nerves and helping the sleep, and the health care composition or the health care product has good application in the fields of improving the sleep and soothing the nerves in view of the effects of the health care composition or the health care product.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings that are needed in the description of the embodiments or the prior art will be briefly described, and it is obvious that the drawings in the description below are some embodiments of the present invention, and other drawings can be obtained according to the drawings without inventive effort for a person skilled in the art.
Fig. 1 is a flowchart of a preparation process of a peanut stem and leaf extract according to an embodiment of the present invention.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to embodiments and examples, but it will be understood by those skilled in the art that the following embodiments and examples are only for illustrating the present invention and should not be construed as limiting the scope of the present invention. The specific conditions are not specified, and the process is carried out according to conventional conditions or conditions suggested by manufacturers. The reagents or apparatus used were conventional products commercially available without the manufacturer's attention.
According to a first aspect of the invention, a health care composition with effects of soothing nerves and aiding sleep is provided, which comprises the following raw materials in parts by weight:
65-85 parts of peanut stem and leaf extract, 6-12 parts of aminobutyric acid, 5-10 parts of theanine and 5-10 parts of cordyceps militaris extract.
The peanut stem and leaf extract is mainly prepared by extracting peanut stem and leaf. Peanut stems and leaves are not traditional Chinese medicines, but are widely applied in China. The components of linalool, ferulic acid, naringenin-4, 7-dimethyl ether, 2' -0-methyl isoliquiritigenin and the like in the peanut stem and leaf have good effects on sleep tranquillization and reliable curative effect. The peanut is planted in a large area in China, the peanut stem and leaf resources are rich, and the guarantee is provided for the acquisition of peanut stem and leaf extracts.
The amount of the peanut stem and leaf extract is also limited, and the typical but non-limiting weight parts of the peanut stem and leaf extract are 65 parts, 66 parts, 68 parts, 70 parts, 72 parts, 74 parts, 75 parts, 76 parts, 78 parts, 80 parts, 82 parts, 84 parts or 85 parts.
Aminobutyric acid is a substance having a certain therapeutic effect on the human body. Because the aminobutyric acid is an important inhibitory neurotransmitter in the central nervous system of a human body, the aminobutyric acid has the effects of calming the heart, tranquilizing the mind, strengthening the brain and improving the intelligence, and can effectively promote sleep and improve insomnia and dreaminess. For females, the aminobutyric acid also has certain effects of maintaining beauty and keeping young. Meanwhile, the traditional Chinese medicine composition has a good blood pressure reducing effect on patients with hypertension. In addition, the composition has certain improvement and protection effects on the liver and kidney of a human body.
Typical, but non-limiting, parts by weight of aminobutyric acid are 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts, 10 parts, 10.5 parts, 11 parts, 11.5 parts, or 12 parts.
Theanine is a special free amino acid in tea, and has sweet taste, and is a main component for promoting fluid production and moistening sweet in tea. Theanine can affect central nerve, promote release of central dopamine in brain, and improve physiological activity of dopamine in brain. The common anti-fatigue effect of tea drink is from the effect to a certain extent. Theanine can effectively reduce hypertension. To some extent, theanine exhibits a antihypertensive effect which is a stabilizing effect which is certainly helpful for recovery of physical and mental fatigue. Theanine can enhance memory and learning by activating central neurotransmitters. Meanwhile, the coffee tea has the function of relieving central hyperexcitation caused by caffeine, so that people can enjoy coffee and the unprecedented feeling of happiness when drinking tea.
Typical, but non-limiting, parts by weight of theanine are 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts or 10 parts.
Cordyceps militaris is also called as Cordyceps militaris, and the extract (Cordyceps militaris extract) can effectively tonify kidney yang, and is mainly used for treating impotence, spermatorrhea and soreness of waist and knees caused by kidney deficiency; can also effectively treat patients with weakness after illness, and has certain relieving effect on senile chronic bronchitis and pulmonary heart disease; can effectively tonify lung and relieve asthma, and has certain relieving effect on patients with cough, such as tuberculosis; can be used for preventing and treating cerebral thrombosis and cerebral hemorrhage. Typical, but not limiting, parts by weight of Cordyceps militaris extract are 5 parts, 5.5 parts, 6 parts, 6.5 parts, 7 parts, 7.5 parts, 8 parts, 8.5 parts, 9 parts, 9.5 parts or 10 parts.
It should be noted that, the ratio of the above raw materials needs to be controlled within the numerical range defined by the present invention, namely (65-85): (6-12): (5-10): (5-10) if the value is outside this range, the tranquillizing and sleep aiding effects of the health care composition are significantly reduced.
According to the invention, the theory of ' monarch, minister, assistant and guide ' of traditional Chinese medicine is used as guidance, peanut branches and leaves have the characteristic of ' day, night and on ', can be synchronous with the principle of yin and yang extinction in nature, sleep at night and on ' day and on ' of the human body sleep ', have sweet and light taste, are slightly bitter and astringent, are nontoxic, enter liver, heart and lung three channels, and have the effects of calming liver and suppressing yang, and soothing the nerves and strengthening brain. And the aminobutyric acid and theanine are used as adjuvants to achieve the effect of sleep tranquillization.
The health care composition with the effects of soothing the nerves and aiding sleep is mainly prepared from the peanut stem and leaf extract, the aminobutyric acid, the theanine, the cordyceps militaris extract and other raw materials in a specific proportion, wherein the peanut stem and leaf extract mainly solves the problem of insomnia and dreaminess, and is matched with the effects of soothing the nerves and calming the nerves of the aminobutyric acid and the theanine, and the health care composition has good effects of soothing the nerves for sleeping and has great practical significance for improving sleeping, relieving fatigue and improving life quality of people through the synergistic interaction of the raw materials.
It should be noted that "comprising", "consisting essentially of … …" in the present invention means that it may comprise other materials in addition to the materials described, which impart different properties to the health care composition. In addition, the "including", "mainly made of … …" described in the present invention may be replaced by "being" or "made of … …" which are closed.
As an alternative embodiment of the invention, the health care composition comprises the following raw materials in parts by weight:
68-80 parts of peanut stem and leaf extract, 8-11 parts of aminobutyric acid, 6.5-10 parts of theanine and 5.5-9 parts of cordyceps militaris extract.
The sleep-aiding and nerve-soothing effects of the health care composition are more remarkable through further optimization of the consumption of the raw materials of the health care composition.
The health composition is not limited in source of peanut stem and leaf extract, and can be obtained commercially or prepared by self.
As an alternative embodiment of the invention, the preparation method of the peanut stem and leaf extract comprises the following steps:
concentrating the extracting solution obtained after extracting the peanut stems and leaves with water, and drying to obtain a crude peanut stem and leaf extract product;
crushing and purifying the crude peanut stem and leaf extract to obtain the peanut stem and leaf extract.
The preparation method has simple process and convenient operation, and can realize full extraction of effective components (such as linalool, ferulic acid, naringenin-4, 7-dimethyl ether, 2' -0-methyl isoliquiritigenin, etc.) in peanut stem and leaf, so that the content of effective components in the peanut stem and leaf extract is high.
In an alternative embodiment of the present invention, the preparation method of the peanut stem and leaf extract comprises extracting peanut stem and leaf with water for 1-3 times.
As an alternative embodiment of the invention, the temperature of each extraction is respectively and independently 90-95 ℃, and the time of each extraction is respectively and independently 1-2h.
Typical, but non-limiting, extraction temperatures are 90 ℃, 91 ℃, 92 ℃, 93 ℃, 94 ℃ or 95 ℃. Typical but non-limiting extraction times are 1h, 1.5h or 2h.
As an alternative embodiment of the present invention, the feed liquid ratio of each extraction is 1: (5-10). The feed liquid ratio refers to the weight ratio of peanut stem and leaf to water of 1:5, 1:6, 1:7, 1:8, 1:9 or 1:10.
By limiting each technological parameter in the extraction process, the effective components in the peanut stems and leaves enter the extracting solution as much as possible.
In an alternative embodiment of the present invention, in the preparation method of the peanut stem and leaf extract, the extract is concentrated to a specific gravity of 1.1-1.2;
as an alternative embodiment of the invention, the drying is spray-drying, preferably at a temperature of 190-210 ℃.
Typical but non-limiting spray drying temperatures are 190 ℃, 195 ℃, 200 ℃, 205 ℃, or 210 ℃.
As an alternative embodiment of the present invention, the size of the comminution is 80-100 mesh. Typical, but non-limiting, comminution particle sizes are 80 mesh, 90 mesh or 100 mesh.
As a preferred embodiment of the invention, the preparation method of the peanut stem and leaf extract comprises the following steps, and the method is specifically shown in fig. 1:
(a) Adding clear water into peanut stems and leaves in an extraction tank according to the weight ratio (feed liquid ratio) of 1:5, heating to 90-95 ℃, carrying out twice soaking, carrying out the first soaking for 2 hours, filtering and collecting water extract, adding water into raw materials, carrying out the second soaking for 1 hour at 90-95 ℃, then combining the two extracts, filtering, centrifuging, carrying out multistage evaporation concentration to obtain peanut stem and leaf concentrated solution with the specific gravity of 1.1-1.2, and carrying out spray drying at 190-210 ℃ to obtain a peanut stem and leaf extract crude product;
(b) The crude product of the peanut stem and leaf extract is crushed in a 10 ten thousand clean area and is filtered by a 80-mesh sieve to remove impurities and purify, so as to obtain the peanut stem and leaf extract.
According to a second aspect of the present invention, there is also provided a method for preparing the above-mentioned health care composition with tranquillizing and sleep aiding effects, comprising the steps of:
mixing the raw materials to obtain the health care composition with the effects of soothing nerves and aiding sleep.
The preparation method has simple process and convenient operation, and is suitable for large-scale industrial production.
According to a third aspect of the invention, a health product is also provided, which comprises the health composition with the effects of soothing nerves and aiding sleep and auxiliary materials.
In view of the advantages of the health care composition with the effects of soothing nerves and aiding sleep, the health care product prepared by adopting the composition also has the same advantages.
The specific kind of the auxiliary material is not limited, and auxiliary materials commonly used in the art can be used.
As an alternative embodiment of the present invention, the adjuvant comprises any one or a combination of at least two of a matrix, a suspending agent, a sweetener or a disintegrant.
The matrix may be used to solubilize a health composition including, but not limited to, vegetable oils. The vegetable oil is, for example, corn oil, sesame oil, palm oil, sunflower seed oil, peanut oil, walnut oil, olive oil, soybean oil, rapeseed oil, etc.
The variety of suspending agents is varied and includes, but is not limited to, beeswax.
The sweetener may be of a variety commonly used in the art including, but not limited to, erythritol, maltitol, xylitol, stevioside, sucrose, white sugar, fructose, brown sugar, or maltose.
Disintegrants include, but are not limited to, gelatin.
The health care composition with the effects of soothing nerves and aiding sleep can be matched with auxiliary materials to prepare health care products with different dosage forms.
As an optional implementation mode, the formulation of the health care product comprises any one of capsules, tablets, pills, granules or oral liquid.
As a preferred embodiment of the invention, the health care product is a soft capsule health care product, and comprises a health care composition and auxiliary materials;
the auxiliary material is peanut oil, and the mass of the health care composition accounts for 10-40% of the total mass of the health care composition and the auxiliary material.
The mass of the health care composition is typically, but not limited to, 10%, 12%, 14%, 15%, 18%, 20%, 22%, 24%, 25%, 28%, 30%, 32%, 34%, 35%, 38% or 40% of the total mass of the health care composition and the auxiliary material.
As a preferred embodiment of the invention, the preparation method of the health care product (soft capsule) comprises the following steps:
mixing the health composition with adjuvants, and filtering to obtain content;
and (3) pelleting the content and the glue solution for forming the soft capsules, shaping, and drying to obtain the health care product in the form of soft capsules.
The above-mentioned gelatin solution for forming soft capsules may be prepared using raw materials conventional in the art, such as purified water, glycerin, gelatin, and the like. In addition, food pigment such as brilliant blue, amaranth, etc. can be added into the glue solution.
According to the fourth aspect of the invention, the application of the health care composition or the health care product with the effects of soothing the nerves and aiding sleep in the fields of improving sleep and soothing the nerves is also provided.
In view of the effects of the health care composition or the health care product with the effects of soothing nerves and aiding sleep, the health care composition or the health care product provided by the invention has good application in the fields of improving sleep and soothing nerves.
The technical scheme provided by the invention is further described below by combining examples and comparative examples.
Example 1
The embodiment provides a health care composition with the effects of soothing nerves and aiding sleep, which is prepared from the following raw materials in parts by weight:
70 parts of peanut stem and leaf extract, 6 parts of aminobutyric acid, 5 parts of theanine and 6 parts of cordyceps militaris extract.
The preparation method of the peanut stem and leaf extract comprises the following steps:
(a) Adding clear water into peanut stem leaves in an extraction tank according to the weight ratio (feed liquid ratio) of 1:5, heating to 92 ℃, carrying out twice soaking, carrying out the first soaking for 2 hours, filtering and collecting water extract, adding water into raw materials, carrying out the second soaking for 1 hour at 92 ℃, then combining the two extracts, carrying out filtration, centrifugation and multistage evaporation to obtain peanut stem leaf concentrated solution with the specific gravity of 1.1-1.2, and carrying out spray drying at 200 ℃ to obtain a peanut stem leaf extract crude product;
(b) The crude product of the peanut stem and leaf extract is crushed in a 10 ten thousand clean area and is filtered by a 80-mesh sieve to remove impurities and purify, so as to obtain the peanut stem and leaf extract.
Example 2
The embodiment provides a health care composition with the effects of soothing nerves and aiding sleep, which is prepared from the following raw materials in parts by weight:
70 parts of peanut stem and leaf extract, 11 parts of aminobutyric acid, 10 parts of theanine and 9 parts of cordyceps militaris extract.
The preparation method of the peanut stem and leaf extract is the same as that of the embodiment 1.
Example 3
The embodiment provides a health care composition with the effects of soothing nerves and aiding sleep, which is prepared from the following raw materials in parts by weight:
65 parts of peanut stem and leaf extract, 12 parts of aminobutyric acid, 5 parts of theanine and 10 parts of cordyceps militaris extract.
The preparation method of the peanut stem and leaf extract is the same as that of the embodiment 1.
Example 4
The embodiment provides a health care composition with the effects of soothing nerves and aiding sleep, which is prepared from the following raw materials in parts by weight:
85 parts of peanut stem and leaf extract, 6 parts of aminobutyric acid, 8 parts of theanine and 5 parts of cordyceps militaris extract.
The preparation method of the peanut stem and leaf extract is the same as that of the embodiment 1.
The preparation method of the health care composition with the effects of soothing nerves and aiding sleep provided in the embodiment 1-4 comprises the following steps:
mixing the raw materials to obtain the health care composition with the effects of soothing nerves and aiding sleep.
Comparative example 1
The comparative example provides a health care composition which is prepared from the following raw materials in parts by weight:
50 parts of peanut stem and leaf extract, 20 parts of aminobutyric acid, 18 parts of theanine and 12 parts of cordyceps militaris extract.
Comparative example 2
The comparative example provides a health care composition which is prepared from the following raw materials in parts by weight:
90 parts of peanut stem and leaf extract, 3 parts of aminobutyric acid, 3 parts of theanine and 4 parts of cordyceps militaris extract.
Comparative example 3
This comparative example provides a health care composition, and the kind and amount of the raw materials are the same as those of example 1 except that aminobutyric acid is not added to the raw materials of example 1.
Comparative example 4
This comparative example provides a health care composition, the same kind and amount of the raw materials as in example 1 except that theanine was not added to the raw materials of example 1.
Comparative example 5
This comparative example provides a health care composition, and the kinds and amounts of the raw materials are the same as those of example 1, except that the cordyceps militaris extract is not added to the raw materials of example 1.
Comparative example 6
This comparative example provides a health care composition, the same kind and amount of the raw materials as in example 1 except that the peanut stem and leaf extract was not added to the raw materials of example 1.
Comparative example 7
This comparative example provides a health care composition, and the kinds and amounts of the raw materials are the same as those of example 1 except that the peanut stem and leaf extract and aminobutyric acid are not added to the raw materials of example 1.
Comparative example 8
This comparative example provides a health care composition comprising only peanut stem and leaf extract as raw material, and the preparation method of the peanut stem and leaf extract is the same as that of example 1.
Comparative example 9
This comparative example provides a health care composition whose raw material includes only aminobutyric acid.
Comparative example 10
This comparative example provides a health care composition whose raw materials include only theanine.
Comparative example 11
The comparative example provides a health care composition, the raw materials of which only comprise Cordyceps militaris extract.
Comparative example 12
The comparative example provides a health care composition, which comprises the following raw materials:
60 parts of peanut stem and leaf extract, 20 parts of wild jujube seed extract and 3 parts of mulberry extract.
Comparative examples 1-12 provide health care compositions prepared in the same manner as examples 1-4.
Example 5-example 8
Examples 5 to 8 respectively provide a health product (soft capsule) comprising the health composition and auxiliary materials provided in examples 1 to 4 respectively;
the auxiliary material is peanut oil, and the mass of the health care composition accounts for 40% of the total mass of the health care composition and the auxiliary material.
The preparation method of the health care product (soft capsule) provided in the embodiment 5-8 comprises the following steps:
mixing the health composition with adjuvants, and filtering to obtain content;
and (3) pelleting the content and the glue solution for forming the soft capsules, shaping, and drying to obtain the health care product in the form of soft capsules.
Comparative example 13 comparative example 24
Comparative examples 13 to 24 respectively provide a health product (soft capsule) comprising the health composition and the auxiliary materials provided in comparative examples 1 to 12, respectively, the amounts of the health composition, the types and amounts of the auxiliary materials, and the preparation methods of the health products are the same as those of examples 5 to 8, and are not repeated here.
In order to compare technical effects of each example and comparative example, the following experimental examples were specially set.
Experimental example
1. Test article
Test 1 (comparative example 12), content: 600g/kg of peanut stem and leaf extract, 200g/kg of spine date seed extract and 30g/kg of mulberry extract; specification of: 200 mg/grain;
test article 2 (example 1), content: 700g/kg of peanut stem and leaf extract, 60g/kg of aminobutyric acid, 50g/kg of theanine and 60g/kg of cordyceps militaris extract; specification of: 200 mg/grain;
test article 3 (comparative example 1), content: 500g/kg of peanut stem and leaf extract, 200g/kg of aminobutyric acid, 180g/kg of theanine and 120g/kg of cordyceps militaris extract; specification of: 200 mg/granule.
2. Reagent(s)
Sodium pentobarbital, lot 202018010925100, specification: 25 g/bottle, molecular weight: 248.25, manufacturer: merck, germany.
Barbital sodium, lot number MY4025, specification: 25 g/bottle, molecular weight: 206.17, manufacturer: jiu Ding chemical (Shanghai) technology Co., ltd.
3. Test animal and raising environment
SPF grade KM mice, 40, male, used for the test weighing 18-22g, provided by Jinan Pengyue test animal breeding Co., ltd., produced license number: SCXK (robust) 20190003, test animal quality certification number: no.370726211101161563. The mice are bred in a ten-thousand-level barrier environment, the temperature difference is 20-25 ℃ and less than or equal to 3 ℃, the ventilation times are 10-20 times per hour, the humidity is 40-70%, the pressure gradient is 20-50Pa, and the day and night light and shade alternation time is 12h/12h; test animal use license number: SCXK (robust) 20180031.
4. Dose design and basis
The doses of the test pieces 1, 2 and 3 were 400 mg/day, the dose for human was 5.71mg/kg based on 70kg of the adult human, and the dose for mice was set to 57.1mg/kg at 10 times the recommended dose. The mice of the three test groups were administered with an intragastric administration volume of 20mL/kg once a day, the negative control group was administered with an equal volume of pure water, and each index was detected after continuous administration of three test groups for 30/33 d.
5. Pharmaceutical formulation
Test 1, 2, 3 solutions: the test pieces 1, 2 and 3 were weighed, 0.043g of the powder was dissolved in pure water and diluted to 15mL, and the concentration of the solution was 2.87g/mL.
6. Main instrument and equipment
LE203E/02 type electronic balance, metrele Tolyduo (Shanghai) Co.
AUW-120D electronic balance, shimadzu corporation, japan.
Uw2200H electronic balance, shimadzu corporation, japan.
7. Test method
(1) Direct sleep test
And observing whether the test animals of the test groups are subjected to the test products of different formulas, and whether the test animals of the test groups sleep after the control groups are subjected to the same volume of solvent. Sleep is indicated by the disappearance of the eversion and the reflection. When the mouse is placed in the dorsum position, the body position can be immediately turned over. If the person cannot turn over for more than 30-60 seconds, the person considers that the turning over reflection disappears and goes to sleep. The recovery of the regular reflection is the arousal of the animal, the time from the disappearance of the regular reflection to the recovery is the sleep time of the animal, and the number of animals falling asleep and the sleep time of the negative control group and the test sample group are recorded.
(2) Sub-threshold dose hypnotic test of sodium pentobarbital
Pre-experiments were performed prior to the formal experiments to determine that the sub-threshold hypnotic doses of pentobarbital sodium were 32mg/kg (7 days of administration), 34mg/kg (14 days of administration), 35mg/kg (30 days of administration), respectively, i.e., the maximum sub-threshold doses of pentobarbital sodium in which 80-90% of the mice did not lose their eversion. The animals were given the test or purified water at the end of 30min, and each group was given the maximum subliminal hypnotic dose of pentobarbital sodium by intraperitoneal injection, and the number of animals falling asleep (the disappearance of the everlasting reflection for more than 1 min) was recorded within 30 min. The test was performed in a quiet environment at 24-25 ℃.
(3) Test for prolonging sleeping time of pentobarbital sodium
Preliminary experiments were performed before the formal experiments, and it was confirmed that the animals were put to sleep for 100% of the time without taking too long a dose of pentobarbital sodium of 53mg/kg (7 and 14 days) and 54mg/kg (30 days) respectively, and the formal experiments were performed with this dose. After animals are fully awake in the pentobarbital subthreshold dose hypnotic test, injecting pentobarbital sodium into the abdominal cavity of each group of animals, taking the disappearance of the eversion and the specular reflection as indexes, and observing the test product to prolong the sleeping time of the pentobarbital sodium.
(4) Barbital sodium sleep latency test
Preliminary experiments were performed prior to the formal experiments to determine that the dose of barbituric sodium that was 100% asleep but not excessive for the sleep time was 270mg/kg (33 days of dosing) and the formal experiments were performed with this dose. And after the animals are given with the test products or pure water with different formulas for 30min at the last time, the animals in each group are injected with the barbital sodium solution intraperitoneally, the effect of the test products on the barbital sodium sleep latency is observed by taking the disappearance of the specular reflection as an index.
(5) Statistics of test data
The metrology data were analyzed using one-way analysis of variance (ANOVA) or T-test. If the variance of the measurement data is uniform, adopting a single-factor variance analysis LSD test. If the variance of the measurement data is not uniform, the Dunnett's T3 one-factor analysis of variance test is used. The number of animals falling asleep is counted and used as the dataX 2 When the total number of cases of the four-grid table is smaller than 40 or the total number of cases is equal to or larger than 40 but the theoretical number of occurrence is equal to or smaller than 1, the exact probability method is adopted.
(6) Result determination
Direct sleep test: and comparing the difference between the number of animals falling asleep and the sleeping time of the control group and the test group, and if the number of animals falling asleep or the sleeping time is obviously increased, the test result is positive.
Pentobarbital sodium subthreshold dose hypnotic test: comparing the difference between the number of animals falling asleep in the control group and the test group, wherein the occurrence rate of animals falling asleep is increased remarkably, and the test result is positive.
Extended pentobarbital sodium sleep time trial: comparing the difference between the sleep time extension of the test group and the control group, and if the sleep time extension is significant, the test result is positive.
Barbital sodium sleep latency test: and comparing the difference between the sleep latency of the control group and the sleep latency of the test group, and if the sleep latency is obviously shortened, the test result is positive.
The test sample can be judged to have the effect of helping to improve the sleep function by adopting the sub-threshold hypnotic test of the sodium pentobarbital, the sleep time test of the sodium pentobarbital and the sleep latency test of the sodium barbital, wherein two of the three tests are positive and have no obvious direct sleep effect.
8. Test results
(1) Influence of three formula test samples of peanut stem and leaf on direct sleep of mice
No direct sleep was observed after administration of 3 formulations of the test samples to the animals in the test group and the same volume of solvent to the negative control group.
(2) Influence of three formulations of peanut stem and leaf test sample on the number of animals falling asleep with sodium pentobarbital in mice
When the test products 1, 2 and 3 are administrated for 7 days, the number of animals falling asleep is 3, 4 and 2 respectively; the number of animals falling asleep is 2 when the administration is carried out for 14 days; the number of animals falling asleep at 30 days is 3, 6, and 3 respectively. Through statistical analysis, the number of sleeping animals in each test group is increased, but compared with the negative control group, the difference has no statistical significance (P is more than 0.05). The specific results are shown in Table 1.
TABLE 1 influence of test substances on the number of animals falling asleep in mice
Note that: n=10
(3) Influence of three samples of peanut stems and leaves on prolonging sleep time of pentobarbital sodium in mice
There was a trend to prolong the sleep time of mice (p=0.07) 7 days of administration of test article 2 compared to the negative control group; the test substances 1, 2 and 3 are administered for 14 days, and no effect of prolonging the sleeping time of the mice is found; the test substances 1 and 2 can be administered for 30 days, so that the sleeping time of the mice can be remarkably prolonged (P < 0.05). The specific results are shown in Table 2.
TABLE 2 Effect of test on prolonged sleep time in mice
Note that: n=10,: p <0.05 compared to the negative control group.
(4) Influence of three samples of peanut stems and leaves on the sleep latency of barbital sodium of mice
Through statistical analysis, the sleep latency of the mice can be shortened after 33 days of administration of the test article 2, and the difference is statistically significant (P < 0.05).
TABLE 3 Effect of test on sleep latency in mice
Note that: n=10,: p <0.05 compared to negative control group
9. Conclusion of the test
After 57.1mg/kg of the preparations 1, 2 and 3 are orally administrated to mice for 30/33d, compared with a negative control group, the sleeping time of the pentobarbital sodium mice can be obviously prolonged after 30 days of administration of the preparation 2, the difference is obvious (P < 0.05), the sleeping latency of the pentobarbital sodium mice can be obviously shortened after 33 days of administration, and no direct sleeping effect exists. From this, it was determined that the test piece 2 had an effect of contributing to improvement of the sleep function of the mice.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present invention, and not for limiting the same; although the invention has been described in detail with reference to the foregoing embodiments, it will be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the invention.
Claims (13)
1. The health care composition with the effects of soothing nerves and aiding sleep is characterized by comprising the following raw materials in parts by weight:
65-85 parts of peanut stem and leaf extract, 6-12 parts of aminobutyric acid, 5-10 parts of theanine and 5-10 parts of cordyceps militaris extract;
the preparation method of the peanut stem and leaf extract comprises the following steps:
concentrating the extracting solution obtained after extracting the peanut stems and leaves with water, and drying to obtain a crude peanut stem and leaf extract product;
crushing and purifying the crude peanut stem and leaf extract to obtain the peanut stem and leaf extract.
2. The health care composition according to claim 1, which is characterized by comprising the following raw materials in parts by weight:
68-80 parts of peanut stem and leaf extract, 8-11 parts of aminobutyric acid, 6.5-10 parts of theanine and 5.5-9 parts of cordyceps militaris extract.
3. The composition of claim 1, wherein the peanut stem and leaf extract is prepared by extracting peanut stem and leaf with water 1-3 times.
4. A health care composition according to claim 3, wherein the temperature of each extraction is independently 90-95 ℃ and the time of each extraction is independently 1-2h.
5. A health care composition according to claim 3, characterized in that the ratio of feed liquid extracted per time is 1: (5-10).
6. The composition according to claim 1, wherein the peanut stem and leaf extract is prepared by concentrating the extract to a specific gravity of 1.1-1.2.
7. The health care composition according to claim 1, wherein the drying is spray drying.
8. The health care composition according to claim 7, wherein the spray-drying temperature is 190-210 ℃.
9. The health care composition according to claim 1, wherein the crushed particle size is 80-100 mesh.
10. The method for preparing the health care composition with tranquillization and sleep aiding effects as claimed in any one of claims 1 to 9, which is characterized by comprising the following steps:
mixing the raw materials to obtain the health care composition with the effects of soothing nerves and aiding sleep.
11. A health product, which is characterized by comprising the health composition with the effects of soothing nerves and aiding sleep as claimed in any one of claims 1-9 and auxiliary materials.
12. The health product of claim 11, wherein the adjuvant comprises any one or a combination of at least two of a matrix, a suspending agent, a sweetener, or a disintegrant.
13. The health product according to claim 11 or 12, wherein the dosage form of the health product comprises any one of a capsule, a tablet, a pill, a granule or an oral liquid.
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