Composition for tonifying qi and blood, helping sleep and improving memory as well as preparation method and application of composition

Abstract

The invention provides a composition for tonifying qi and blood, helping sleep and improving memory as well as a preparation method and application thereof, and relates to the technical field of traditional Chinese medicines. The composition is prepared from the following raw material components in parts by weight: 5 to 50 parts of radix astragali seu hedysari, 5 to 30 parts of radix angelicae sinensis, 5 to 25 parts of fructus crataegi, 1 to 15 parts of pericarpium citri reticulatae, 5 to 40 parts of fructus mori, 5 to 25 parts of fructus hordei germinatus, 1 to 15 parts of herba dendrobii and 1 to 25 parts of radix panacis quinquefolii. The preparation method comprises the following steps: decocting dendrobium nobile, and performing enzymolysis by using a compound enzyme of cellulase and pectinase to obtain a dendrobium nobile extract; the preparation method comprises the following steps: soaking astragalus membranaceus, angelica sinensis, malt and American ginseng in water, performing ultrasonic treatment, and decocting to obtain filter residues 1 and filtrate 1; mixing filter residues with hawthorn, pericarpium citri reticulatae and mulberries, continuing to add water to decoct, filtering to obtain filtrate 2, and combining the dendrobium extract with all the filtrate to obtain the composition. All the raw material components in the composition cooperate with one another, and the obvious effects of tonifying qi and blood, improving immunity, improving insomnia and improving memory are achieved.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a composition for replenishing qi and blood, promoting sleep, and improving memory, as well as a preparation method and application thereof. Background Art

[0002] Western medicine often uses sedative hypnotics, anti-anxiety drugs, antidepressants or hormone replacement therapy for insomnia. The following adverse reactions are likely to occur during the medication process: memory loss, decreased concentration, fatigue, insufficient qi and blood, and long-term use is prone to tolerance and dependence. Traditional Chinese medicine calls insomnia "insomnia", and the main location of sleep is in the heart and brain. Insomnia occurs due to the loss of nourishment to the mind or the disturbance of the mind, and the mind cannot stay in the body; insomnia also occurs due to kidney essence deficiency, the brain is not nourished, and the mind cannot stay. Insomnia also occurs due to insufficient qi and blood, excessive mental work, consumption of yin blood, or insufficient qi and blood, which can all lead to insufficient qi and blood, no way to nourish the mind, the brain loses its nourishment, and the heart and brain are restless, resulting in insomnia. Insufficient qi and blood will also be unable to promote blood circulation, causing blood stasis, which will not only accelerate the aging process, but also cause memory disorders and reduce immunity.

[0003] At present, there are many prescriptions for Chinese medicine about replenishing qi and blood and improving insomnia. According to different etiologies and pathogenesis, the prescriptions are different according to different syndromes. Chinese invention patent CN103520368A discloses a Chinese medicine health-preserving preparation for replenishing qi and blood and enhancing immunity, which is made of the following raw materials in parts by weight: 5-25 parts of donkey-hide gelatin, 15-35 parts of codonopsis, 10-30 parts of angelica, 10-30 parts of astragalus, 5-25 parts of wolfberry, 1-5 parts of pilose antler, and 1-5 parts of hemoglobin. The preparation of this invention has a certain effect on spleen and stomach weakness, fatigue, low immunity, low back pain and abdominal distension, fatigue and few words, insomnia and forgetfulness, irregular menstruation, menopausal syndrome, etc. caused by insufficient qi and blood.

[0004] Chinese invention patent CN116350725A discloses a Chinese medicine composition for treating insomnia of deficiency of both heart and spleen. The Chinese medicine composition is prepared by extracting the following raw materials in parts by weight: 20-30 parts of astragalus, 15-25 parts of atractylodes, 20-30 parts of angelica, 15-25 parts of dried tangerine peel, 30-40 parts of hawthorn, 20-30 parts of malt, 15-25 parts of radish seeds, 10-20 parts of cyperus rotundus, 20-30 parts of smilax china, 10-20 parts of spiny jujube seeds, 20-30 parts of tuckahoe, 10-20 parts of liquorice, 10-20 parts of poria, 15-25 parts of prepared rehmannia, 10-20 parts of ligusticum, 15-25 parts of polygala, 8-12 parts of fritillaria, 15-20 parts of arisaema, 10-20 parts of bupleurum and 10-20 parts of anemarrhena. The Chinese medicine composition of the invention can nourish the heart and spleen, harmonize the stomach and eliminate stagnation, calm the mind and soothe the nerves, nourish the blood and soothe the nerves, resolve phlegm and relieve turbidity, soothe the liver and relieve restlessness, and has a good effect in treating insomnia of heart and spleen deficiency type. However, the Chinese medicine composition does not show the effect of improving memory.

[0005] In addition, Chinese invention patent CN116036224A discloses a Chinese medicine composition for improving sleep and learning and memory ability, as well as its preparation method and application. The Chinese medicine composition includes the following raw materials in parts by weight: 0.1-0.5 parts of Cordyceps sinensis, 15-20 parts of White Peony Root, 10-15 parts of Cinnamon Twig, 28-32 parts of Jujube, 3-7 parts of Dried Ginger, 10-15 parts of Raw Sun-dried Ginseng, 5-10 parts of Rehmannia Glutinosa, 15-20 parts of Polygonatum, 10-15 parts of Angelica Sinensis, 15-20 parts of Astragalus and 3-7 parts of Yellow Gelatin. The Chinese medicine composition of the invention can nourish qi and blood, promote the production of body fluid and transform essence to calm the mind and calm the mind, and is mainly suitable for people with poor sleep quality, forgetfulness or decreased learning and memory ability, such as insufficient essence and blood.

[0006] Although there are many Chinese medicine prescriptions that have the effects of replenishing qi and blood and improving insomnia, most of the prescriptions have many Chinese medicine ingredients, the prescriptions are complicated, and most of them do not show the effect of synergistic enhancement, and the effects of improving memory, replenishing qi and blood, and helping sleep are weak. Based on this, it is necessary to further study the selection and proportion of the components of the Chinese medicine composition, and provide a Chinese medicine composition with a simplified prescription, the components interact with each other, synergistically enhance the effect, and can significantly improve insomnia, improve memory, and replenish qi and blood. Summary of the invention

[0007] In view of the problems existing in the prior art, the present invention provides a composition for replenishing qi and blood, promoting sleep and improving memory, as well as a preparation method and application thereof. Astragalus, angelica, hawthorn, tangerine peel, mulberry, malt, dendrobium and American ginseng are used in combination with each other to bring about the synergistic effects of replenishing qi and blood, improving immunity, improving insomnia and improving memory.

[0008] To achieve the above purpose, the technical solution adopted by the present invention is as follows:

[0009] First, the present invention provides a composition for replenishing qi and blood, promoting sleep, and improving memory. The raw material components include, by weight: 5-50 parts of astragalus, 5-30 parts of angelica, 5-25 parts of hawthorn, 1-15 parts of tangerine peel, 5-40 parts of mulberry, 5-25 parts of malt, 1-15 parts of dendrobium and 1-25 parts of American ginseng.

[0010] Preferably, the composition comprises, by weight, 12-20 parts of astragalus, 8-15 parts of angelica, 12-20 parts of hawthorn, 8-12 parts of tangerine peel, 13-16 parts of mulberry, 12-20 parts of malt, 8-12 parts of dendrobium and 13-20 parts of American ginseng.

[0011] Further preferably, the composition comprises, by weight, 16 parts of astragalus, 12 parts of angelica, 15 parts of hawthorn, 10 parts of tangerine peel, 14 parts of mulberry, 15 parts of malt, 10 parts of dendrobium and 16 parts of American ginseng.

[0012] Then, the present invention provides a method for preparing the above composition, comprising the steps of:

[0013] (1) Preparing a dendrobium extract: boiling the dendrobium with water to obtain a decoction mixture; after the decoction mixture is cooled, adding a composite enzyme for enzymolysis to obtain a dendrobium extract; the composite enzyme is cellulase and pectinase;

[0014] (2) soaking astragalus, angelica, malt and ginseng in water, ultrasonically treating, decocting and filtering to obtain filtrate 1 and residue 1;

[0015] (3) Mix the residue 1 with hawthorn, tangerine peel and mulberry, continue to add water for decoction, filter and obtain filtrate 2;

[0016] (4) combining filtrate 1 and filtrate 2, concentrating and drying to obtain a mixture; and mixing the mixture with the dendrobium officinale extract to obtain a composition.

[0017] Preferably, in step (1), the solid-liquid ratio of the decoction is 1:8-20 g / mL, and the decoction time is 1-3 h.

[0018] Further preferably, in step (1), the solid-liquid ratio of the decoction is 1:15 g / mL, and the decoction is performed for 2 hours.

[0019] Preferably, in step (1), the cooling temperature is 38-45°C.

[0020] Further preferably, in step (1), the cooling temperature is 42°C.

[0021] Preferably, in step (1), the mass ratio of the cellulase to the pectinase is 1:1.2-5.

[0022] Further preferably, in step (1), the mass ratio of the cellulase to the pectinase is 1:3.

[0023] Preferably, in step (1), the added amount of the complex enzyme is 1-3 mg complex enzyme / 50-300 mg Dendrobium officinale.

[0024] Further preferably, in step (1), the added amount of the complex enzyme is 2 mg complex enzyme / 200 mg Dendrobium.

[0025] Preferably, in step (1), the enzymatic hydrolysis temperature is 38-45°C, and the enzymatic hydrolysis time is 18-48h.

[0026] Further preferably, in step (1), the enzymatic hydrolysis temperature is 42° C. and the enzymatic hydrolysis time is 36 h.

[0027] Preferably, in step (2), the solid-to-liquid ratio of the water-immersion is 1:8-20 g / mL.

[0028] Further preferably, in step (2), the solid-to-liquid ratio of the water-immersion is 1:15 g / mL.

[0029] Preferably, in step (2), the ultrasonic treatment time is 0.5-2h.

[0030] Further preferably, in step (2), the ultrasonic treatment time is 1 h.

[0031] Preferably, in step (2), the decocting time is 0.5-2h.

[0032] Further preferably, in step (2), the decocting time is 1 hour.

[0033] Preferably, in step (3), the solid-liquid ratio of the decoction is 1:6-15 g / mL, and the decoction time is 1-3 h.

[0034] Preferably, in step (3), the solid-liquid ratio of the decoction is 1:10 g / mL, and the decoction is performed for 2 hours.

[0035] Furthermore, the present invention provides the use of the above composition in the preparation of medicines with the effects of replenishing qi and blood, promoting sleep, and improving memory.

[0036] Finally, the present invention provides a medicine with the effects of replenishing qi and blood, promoting sleep, and improving memory, comprising the components: the above-mentioned composition.

[0037] Preferably, the drug further comprises a component: a drug carrier.

[0038] The pharmaceutical carrier used can be solid, liquid or gas. Examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate and stearic acid. Examples of liquid carriers include syrup, peanut oil, olive oil and water. Examples of gaseous carriers include carbon dioxide and nitrogen.

[0039] When preparing the composition for oral dosage form, any convenient pharmaceutical medium can be used. For example, water, ethanol, oil, alcohol, flavoring agent, preservative, coloring agent, etc. can be used to form oral liquid preparations, such as suspensions and solutions; while carriers, such as starch, sugars, microcrystalline cellulose, diluents, granulating agents, emulsifiers, lubricants, binders, disintegrants can be used to form oral solid preparations, such as powders, capsules and tablets. Tablets and capsules are the preferred oral dosage units using solid pharmaceutical carriers due to their ease of administration. Tablets can be coated using standard aqueous or non-aqueous techniques.

[0040] Tablets containing the Chinese medicine composition or extract of the present invention can be prepared by tableting or molding, and one or more auxiliary ingredients or adjuvants can be used. The active ingredient can be tableted in a free-flowing form (such as powder or granules) in a suitable machine, and can be mixed with a binder, a lubricant, an inert diluent, a surfactant or a dispersant to prepare a tablet. Molded tablets can be molded in a suitable machine, i.e., a powdered compound mixture moistened with an inert liquid diluent. Each tablet preferably contains about 0.05 mg to about 5 g of active ingredient, and each sachet or capsule preferably contains about 0.05 mg to about 5 g of active ingredient. For example, a preparation intended for oral administration to humans may contain about 0.5 mg to about 5 g of active drug, mixed with an appropriate and convenient carrier material, which may account for about 5% to 95% of the total composition. The unit dosage form usually contains about 1 mg to about 2 g of active ingredient, usually 25 mg, 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, 800 mg or 1000 mg.

[0041] The pharmaceutical composition suitable for parenteral administration of the present invention can be prepared as an aqueous solution or suspension of the active compound. Suitable surfactants such as hydroxypropylcellulose can be included. Dispersions can also be prepared in glycerol, liquid polyethylene glycol and oil mixtures thereof. In addition, preservatives can be added to prevent the harmful growth of microorganisms.

[0042] Medicine of the present invention can be in the form suitable for topical use, for example aerosol, cream, ointment, lotion, powder or the like. In addition, composition can be in the form suitable for transdermal administration device. Can use Chinese medicine composition of the present invention, prepare these prescriptions by conventional processing method. For example, by mixing hydrophilic material and water, and about 5wt% to about 10wt% of compound, prepare cream or ointment with required consistency.

[0043] The medicine of the present invention can be in a form suitable for rectal administration, wherein the carrier is a solid. Preferably, the mixture is made into a unit dose suppository. Suitable carriers include cocoa butter and other materials commonly used in the art. Suppositories can be prepared by first forming a composition containing a softened or melted carrier, followed by cooling and shaping in a mold.

[0044] In addition to the above-mentioned carrier components, the above-mentioned pharmaceutical preparations may include (if applicable) one or more additional carrier components, such as diluents, buffers, flavoring agents, adhesives, surfactants, thickeners, lubricants, preservatives (including antioxidants), etc. In addition, other excipients, such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, etc., colorants and flavoring agents, etc., may be added. The preparation is made isotonic with the blood of the intended recipient. The components containing the Chinese medicine composition of the present invention can also be prepared in the form of powder or concentrate.

[0045] Preferably, the dosage form of the drug is not limited to pills, capsules, granules, oral liquids, powders, tablets, lozenges, pastes and other dosage forms, and suitable drug carriers in the art can be selected for different dosage forms.

[0046] Solution:

[0047] 1. Core Qi and blood dual-tonifying structure: Astragalus is used as the main medicine, which fully exerts its effects of tonifying Qi and raising Yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, and promoting the generation and circulation of Qi and blood throughout the body; Angelica is used as the auxiliary medicine, which can tonify blood, activate blood circulation, regulate menstruation and relieve pain, and follows the principle of mutual generation of Qi and blood in "Danggui Buxue Tang" with Astragalus. Through matching and ratio, the efficacy of tonifying Qi and generating blood is enhanced to ensure sufficient and smooth flow of Qi and blood.

[0048] 2. Synergistic system of spleen and stomach transportation and transformation: Tangerine peel regulates qi and strengthens the spleen, dries dampness and resolves phlegm, dissolves the greasiness of tonic drugs, and facilitates spleen and stomach transportation and transformation. As an adjuvant, it helps the absorption of other medicinal materials; hawthorn helps digestion and strengthens the stomach, promotes qi and disperses blood stasis, and assists the spleen and stomach in digestion; malt promotes qi and digestion, strengthens the spleen and stimulates appetite, and builds a synergistic system with tangerine peel and hawthorn, which comprehensively promotes the spleen and stomach's absorption and transformation of drugs and food nutrients, laying a solid foundation for the formation of qi and blood.

[0049] 3. Yin-nourishing and heat-clearing balancing mechanism: mulberry nourishes yin and blood, produces fluid and moistens dryness, nourishes the yin of the liver and kidney, and provides protection for the formation of yin blood; Dendrobium benefits the stomach and produces fluid, nourishes yin and clears heat, nourishes stomach yin to help the spleen and stomach function, and works together with mulberry to regulate liver and kidney yin deficiency; American ginseng replenishes qi and nourishes yin, clears heat and produces fluid, assists astragalus in replenishing qi, balances the warm and dry nature of astragalus and angelica, replenishes yin fluid for the body, and enables the whole formula to maintain yin and yang balance while replenishing qi and blood to avoid getting angry.

[0050] 4. Nerve regulation and brain function improvement: Traditional Chinese medicine believes that the heart governs the mind, and the fullness of qi and blood and the harmony of yin and yang are the basis for the normal mind of the heart. The composition of the present invention improves sleep and memory by comprehensively replenishing qi and blood, nourishing the liver and kidneys, and nourishing the heart.

[0051] In the present invention, the astragalus is the dried root of the leguminous plant Astragalus mongolica or Astragalus membranaceus; it is sweet, warm, and enters the lung and spleen meridians, and has the effects of nourishing the heart and spleen, and replenishing qi and strengthening the exterior.

[0052] In the present invention, the angelica root is sweet, pungent and warm; it enters the liver, heart and spleen meridians; it has the effects of nourishing blood and activating blood circulation, regulating menstruation and relieving pain, moistening the intestines and relieving constipation, and nourishing the heart and spleen;

[0053] In the present invention, the hawthorn fruit enters the spleen, stomach and liver meridians, and has the effects of harmonizing the stomach and removing stagnation, digesting food and removing accumulation, and promoting qi and dispersing blood stasis.

[0054] In the present invention, the tangerine peel is returned to the lung and spleen meridians, and has the effects of regulating qi, strengthening the spleen and stimulating appetite.

[0055] In the present invention, the mulberry is the mature fruit of the deciduous tree mulberry of the Moraceae family; the medicinal properties are sweet, sour and cold, and it enters the heart, liver and kidney meridians, and can be used to treat various symptoms of yin and blood deficiency, thirst and thirst caused by loss of body fluid, dry intestine and constipation, and has the effects of lowering blood lipids and blood pressure, and strengthening the spleen and nourishing the stomach.

[0056] In the present invention, the malt is sweet and mild in nature, enters the spleen and stomach meridians, and has the effects of promoting qi and digestion, strengthening the spleen and stimulating appetite, promoting urination, and calming the nerves.

[0057] In the present invention, the dendrobium is sweet in taste, slightly cold in nature, and enters the stomach and kidney meridians; it is used for damage to body fluid caused by febrile disease, dry mouth and thirst, insufficient stomach yin, poor appetite and dry retching, persistent deficiency heat after illness, yin deficiency and hyperactivity of fire, bone steaming and fatigue fever, blurred vision, and weakness of tendons and bones; the dendrobium has the effects of improving sleep, calming the mind, and can relieve emotional problems such as insomnia, anxiety, and irritability.

[0058] In the present invention, the American ginseng is sweet, slightly bitter, cold in nature, and enters the lung, heart, kidney, and spleen meridians; it has the effects of replenishing vital energy, replenishing the lung, heart, kidney, spleen qi yin, clearing away fire and generating body fluid, and clearing the heart and calming the mind.

[0059] Compared with the prior art, the present invention has the following beneficial effects:

[0060] 1. The present invention uses astragalus, angelica, hawthorn, tangerine peel, mulberry, malt, dendrobium and American ginseng as components of the composition. The components are coordinated with each other, the formula is simplified, and significant effects of replenishing qi and blood, calming the nerves and promoting sleep, and improving memory are brought about.

[0061] 2. The present invention first decocts the dendrobium to destroy the tissue morphology, and then adds cellulase and pectinase to further decompose the cellulose and pectin on the cell wall, so that the effective ingredients are dissolved in large quantities under mild conditions without destroying the activity of the effective ingredients, which is beneficial to the effects of promoting sleep and improving memory; the astragalus, angelica, malt and American ginseng components are decocted after ultrasonic treatment, which is beneficial to the dissolution of the active ingredients and brings about a significantly improved effect of replenishing qi and blood. DETAILED DESCRIPTION

[0062] The following non-limiting examples can enable those skilled in the art to more fully understand the present invention, but do not limit the present invention in any way. The following content is merely an exemplary description of the scope of the present invention, and those skilled in the art can make various changes and modifications to the present invention based on the disclosed content, which should also fall within the scope of the present invention.

[0063] When the embodiments give numerical ranges, it should be understood that, unless otherwise specified in the present invention, both endpoints of each numerical range and any numerical value between the two endpoints can be selected. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meanings as those generally understood by those of ordinary skill in the art to which the present invention belongs.

[0064] The present invention is further described below by way of specific examples. Unless otherwise specified, the various chemical reagents and raw materials used in the examples of the present invention are obtained through conventional commercial channels.

[0065] Example 1

[0066] A composition for replenishing qi and blood, promoting sleep and improving memory comprises the following raw material components by weight: 16 parts of astragalus, 12 parts of angelica, 15 parts of hawthorn, 10 parts of tangerine peel, 14 parts of mulberry, 15 parts of malt, 10 parts of dendrobium and 16 parts of American ginseng.

[0067] The preparation method of the composition is:

[0068] (1) Preparing a dendrobium extract: decoct the dendrobium with water at a solid-liquid ratio of 1:15 g / mL for 2 h to obtain a decoction mixture; cool the decoction mixture to 42° C., add a composite enzyme of cellulase and pectinase, and perform enzymolysis at 42° C. for 36 h to obtain a dendrobium extract; the mass ratio of cellulose to pectinase is 1:3, and the amount of the composite enzyme added is 2 mg composite enzyme / 200 mg dendrobium;

[0069] (2) Astragalus, Angelica, malt and American ginseng were soaked in water, ultrasonically treated for 1 h at a solid-liquid ratio of 1:15 g / mL, decocted for 1 h, and filtered to obtain filtrate 1 and residue 1;

[0070] (3) Mix the residue 1 with hawthorn, tangerine peel, and mulberry, add water, and continue to boil for 2 h at a solid-liquid ratio of 1:10 g / mL, filter, and obtain filtrate 2;

[0071] (4) combining filtrate 1 and filtrate 2, concentrating, and freeze-drying to obtain a mixture; and uniformly stirring the mixture and the dendrobium officinale extract to obtain a composition.

[0072] Example 2

[0073] A composition for replenishing qi and blood, promoting sleep and improving memory comprises the following raw material components by weight: 12 parts of astragalus, 8 parts of angelica, 12 parts of hawthorn, 8 parts of tangerine peel, 13 parts of mulberry, 12 parts of malt, 8 parts of dendrobium and 13 parts of American ginseng.

[0074] The preparation method of the composition is:

[0075] (1) Preparing a dendrobium extract: decoct the dendrobium with water at a solid-liquid ratio of 1:8 g / mL for 3 h to obtain a decoction mixture, cool the decoction mixture to 38° C., add a composite enzyme of cellulase and pectinase, and perform enzymolysis at 38° C. for 48 h to obtain a dendrobium extract; the mass ratio of cellulose to pectinase is 1:3, and the amount of the composite enzyme added is 2 mg composite enzyme / 200 mg dendrobium;

[0076] (2) Astragalus, Angelica, malt and American ginseng were soaked in water, ultrasonically treated for 0.5 h at a solid-liquid ratio of 1:8 g / mL, boiled for 2 h, and filtered to obtain filtrate 1 and residue 1;

[0077] (3) Mix the residue 1 with hawthorn, tangerine peel, and mulberry, add water, and continue to boil for 1 h at a solid-liquid ratio of 1:6 g / mL, filter, and obtain filtrate 2;

[0078] (4) combining filtrate 1 and filtrate 2, concentrating, and freeze-drying to obtain a mixture; and uniformly stirring the mixture and the dendrobium officinale extract to obtain a composition.

[0079] Example 3

[0080] A composition for replenishing qi and blood, promoting sleep and improving memory comprises the following raw material components by weight: 20 parts of astragalus, 15 parts of angelica, 20 parts of hawthorn, 12 parts of tangerine peel, 16 parts of mulberry, 20 parts of malt, 12 parts of dendrobium and 20 parts of American ginseng.

[0081] The preparation method of the composition is:

[0082] (1) Preparing a dendrobium extract: decoct the dendrobium with water at a solid-liquid ratio of 1:20 g / mL for 1 hour to obtain a decoction mixture, cool the decoction mixture to 45° C., add a composite enzyme of cellulase and pectinase, and perform enzymolysis at 45° C. for 18 hours to obtain a dendrobium extract; the mass ratio of cellulose to pectinase is 1:3, and the amount of the composite enzyme added is 1 mg composite enzyme / 50 mg dendrobium;

[0083] (2) Astragalus, Angelica, malt and Panax notoginseng were soaked in water, ultrasonically treated for 2 h at a solid-liquid ratio of 1:20 g / mL, decocted for 0.5 h, and filtered to obtain filtrate 1 and residue 1;

[0084] (3) Mix the residue 1 with hawthorn, tangerine peel, and mulberry, add water, and continue to boil for 3 hours at a solid-liquid ratio of 1:15 g / mL, filter, and obtain filtrate 2;

[0085] (4) combining filtrate 1 and filtrate 2, concentrating, and freeze-drying to obtain a mixture; and uniformly stirring the mixture and the dendrobium officinale extract to obtain a composition.

[0086] Example 4

[0087] The difference from Example 1 is that the weight proportions of the raw materials in the composition are different.

[0088] A composition for replenishing qi and blood, promoting sleep and improving memory comprises the following raw materials in parts by weight: 5 parts of astragalus, 5 parts of angelica, 5 parts of hawthorn, 1 part of tangerine peel, 5 parts of mulberry, 5 parts of malt, 1 part of dendrobium and 1 part of American ginseng.

[0089] The rest are the same as in Example 1.

[0090] Example 5

[0091] The difference from Example 1 is that the weight proportions of the raw materials in the composition are different.

[0092] A composition for replenishing qi and blood, promoting sleep and improving memory comprises the following raw material components by weight: 50 parts of astragalus, 30 parts of angelica, 25 parts of hawthorn, 15 parts of tangerine peel, 40 parts of mulberry, 25 parts of malt, 15 parts of dendrobium and 25 parts of American ginseng.

[0093] The rest are the same as in Example 1.

[0094] Example 6

[0095] Different from Example 1, in the composite enzyme used in step (1) to prepare the Dendrobium extract, the mass ratio of cellulase to pectinase is different. The mass ratio of cellulase to pectinase is 1:1.2.

[0096] The rest are the same as in Example 1.

[0097] Example 7

[0098] Different from Example 1, in the composite enzyme used in step (1) to prepare the Dendrobium extract, the mass ratio of cellulase to pectinase is different, and the mass ratio of cellulase to pectinase is 1:5.

[0099] The rest are the same as in Example 1.

[0100] Comparative Example 1

[0101] The difference from Example 1 is that the raw material components of the composition are different.

[0102] A composition for replenishing qi and blood, promoting sleep and improving memory comprises the following raw material components by weight: 16 parts of astragalus, 15 parts of hawthorn, 10 parts of dendrobium and 15 parts of malt.

[0103] The preparation method of the composition is:

[0104] (1) Preparing a dendrobium extract: decoct the dendrobium with water at a solid-liquid ratio of 1:15 g / mL for 2 h to obtain a decoction mixture, cool the decoction mixture to 42° C., add a composite enzyme of cellulase and pectinase, and perform enzymolysis at 42° C. for 36 h to obtain a dendrobium extract; the mass ratio of cellulose to pectinase is 1:3, and the amount of the composite enzyme added is 2 mg composite enzyme / 200 mg dendrobium;

[0105] (2) soaking astragalus and malt in water, ultrasonically treating for 1 h at a solid-liquid ratio of 1:15 g / mL, boiling for 1 h, filtering, and obtaining filtrate 1 and residue 1;

[0106] (3) Mix the residue 1 with hawthorn, add water, continue to boil for 2 h at a solid-liquid ratio of 1:10 g / mL, filter, and obtain filtrate 2;

[0107] (4) combining filtrate 1 and filtrate 2, concentrating, and freeze-drying to obtain a mixture; and uniformly stirring the mixture and the dendrobium officinale extract to obtain a composition.

[0108] Comparative Example 2

[0109] The difference from Example 1 is that the raw material components of the composition are different.

[0110] A composition for replenishing qi and blood, promoting sleep and improving memory comprises the following raw material components by weight: 12 parts of angelica sinensis, 14 parts of mulberry, 10 parts of tangerine peel and 16 parts of American ginseng.

[0111] The preparation method of the composition is:

[0112] (1) Soaking angelica and American ginseng in water, ultrasonically treating for 1 h at a solid-liquid ratio of 1:15 g / mL, boiling for 1 h, and filtering to obtain filtrate 1 and residue 1;

[0113] (2) Mix the residue 1 with dried tangerine peel and mulberry, add water, continue to boil for 2 h at a solid-liquid ratio of 1:10 g / mL, and filter to obtain filtrate 2;

[0114] (3) Filtrate 1 and Filtrate 2 were combined, concentrated, and freeze-dried to obtain a composition.

[0115] Comparative Example 3

[0116] The difference from Example 1 is that the raw material components of the composition are different, and American ginseng is replaced by Poria cocos.

[0117] A composition for replenishing qi and blood, promoting sleep and improving memory comprises the following raw material components by weight: 16 parts of astragalus, 12 parts of angelica, 15 parts of hawthorn, 10 parts of tangerine peel, 14 parts of mulberry, 15 parts of malt, 10 parts of dendrobium and 16 parts of tuckahoe.

[0118] The preparation method of the composition is:

[0119] (1) Preparing a dendrobium extract: decoct the dendrobium with water at a solid-liquid ratio of 1:15 g / mL for 2 h to obtain a decoction mixture; cool the decoction mixture to 42° C., add a composite enzyme of cellulase and pectinase, and perform enzymolysis at 42° C. for 36 h to obtain a dendrobium extract; the mass ratio of cellulose to pectinase is 1:3, and the amount of the composite enzyme added is 2 mg composite enzyme / 200 mg dendrobium;

[0120] (2) Astragalus, Angelica, malt and Poria were soaked in water, ultrasonically treated for 1 h at a solid-liquid ratio of 1:15 g / mL, decocted for 1 h, and filtered to obtain filtrate 1 and residue 1;

[0121] (3) Mix the residue 1 with hawthorn, tangerine peel, and mulberry, add water, and continue to boil for 2 h at a solid-liquid ratio of 1:10 g / mL, filter, and obtain filtrate 2;

[0122] (4) combining filtrate 1 and filtrate 2, concentrating, and freeze-drying to obtain a mixture; and uniformly stirring the mixture and the dendrobium officinale extract to obtain a composition.

[0123] Comparative Example 4

[0124] The difference from Example 1 is that the weight ratio of the raw material components of the composition is different.

[0125] A composition for replenishing qi and blood, promoting sleep and improving memory comprises the following raw material components by weight: 2 parts of astragalus, 12 parts of angelica, 35 parts of hawthorn, 20 parts of tangerine peel, 23 parts of mulberry, 15 parts of malt, 0.5 parts of dendrobium and 0.5 parts of American ginseng.

[0126] The rest are the same as in Example 1.

[0127] Comparative Example 5

[0128] Different from Example 1, the enzymatic hydrolysis preparation of the dendrobium extract was not performed. The preparation method of the composition is:

[0129] (1) Astragalus, Angelica, malt, Dendrobium and Panax notoginseng were soaked in water, ultrasonically treated for 1 h at a solid-liquid ratio of 1:15 g / mL, decocted for 1 h, and filtered to obtain filtrate 1 and residue 1;

[0130] (2) Mix the residue 1 with hawthorn, tangerine peel, and mulberry, add water, and continue to boil for 2 h at a solid-liquid ratio of 1:10 g / mL, filter, and obtain filtrate 2;

[0131] (3) Filtrate 1 and Filtrate 2 were combined, concentrated, and freeze-dried to obtain a composition.

[0132] Comparative Example 6

[0133] Different from Example 1, in the preparation process of the dendrobium extract in step (1), the enzyme used is only one component, cellulase. The preparation method of the composition is:

[0134] (1) Preparing a dendrobium extract: decoct the dendrobium with water at a solid-liquid ratio of 1:15 g / mL for 2 h to obtain a decoction mixture; cool the decoction mixture to 42° C., add cellulase, and perform enzymolysis at 42° C. for 36 h to obtain a dendrobium extract; the amount of cellulase added is 2 mg cellulase / 200 mg dendrobium;

[0135] (2) Astragalus, Angelica, malt and American ginseng were soaked in water, ultrasonically treated for 1 h at a solid-liquid ratio of 1:15 g / mL, decocted for 1 h, and filtered to obtain filtrate 1 and residue 1;

[0136] (3) Mix the residue 1 with hawthorn, tangerine peel, and mulberry, add water, and continue to boil for 2 h at a solid-liquid ratio of 1:10 g / mL, filter, and obtain filtrate 2;

[0137] (4) combining filtrate 1 and filtrate 2, concentrating, and freeze-drying to obtain a mixture; and uniformly stirring the mixture and the dendrobium officinale extract to obtain a composition.

[0138] Test 1: Testing the effect of replenishing qi and blood and enhancing immunity

[0139] Experimental animals: 18-22g female SPF Kunming mice, adapted for 1 week, at a temperature of 20-25°C and a humidity of 40%-70%RH.

[0140] Experimental groups: The mice were divided into 14 groups, 7 mice in each group, namely the control group, embodiment group 1, embodiment group 2, embodiment group 3, embodiment group 4, embodiment group 5, embodiment group 6, embodiment group 7, comparative example group 1, comparative example group 2, comparative example group 3, comparative example group 4, comparative example group 5 and comparative example group 6.

[0141] Administration method: Except for the control group, the mice in the other groups were gavaged with the corresponding composition every day, with a gavage dose of 1.0 g / kg; the control group was gavaged with the same dose of distilled water, once a day, for 30 consecutive days.

[0142] Experimental methods:

[0143] (1) Half hemolysis value (HC 50 ) determination: gavage the composition for 30 days, intraperitoneally inject 2% SRBC on the 25th day, dislocate and kill 5 days after immunization, collect serum, add 1mL of 300-fold diluted serum, 0.5mL of 10% SRBC, and 1mL of complement into the test tube, bathe at 37℃ for 20 minutes, terminate the reaction in ice bath, centrifuge, take 1mL of supernatant, add 3mL of Dulbecco's reagent, and colorimetric at 540nm after 10 minutes. Half hemolysis value (HC 50 )The test results are shown in Table 1.

[0144] (2) Antibody-producing cell detection: The spleen of the mice killed in (1) was taken, the supporting cell suspension was filtered through a 200-mesh screen, mixed with Han's solution, and dispensed into small test tubes, 0.5 mL per tube, 50 μL of 10% SRBC and 20 μL of spleen cell suspension were added, mixed, inverted, and cultured in a carbon dioxide incubator for 1 hour, complement diluted with SA buffer (Sulfosalicylic acid buffer) (1:10) was added, and the culture was continued for 1 hour, and the number of hemolytic plaques was counted. The results of the number of hemolytic plaques are shown in Table 1.

[0145] Table 1

[0146] <![CDATA[HC 50 ]]> <![CDATA[Number of hemolytic plaques (×10 3 / total spleen)]]> Control group 221.8±11.5 55.4±5.1 Example 1 <![CDATA[273.9±10.2 ## ]]> <![CDATA[69.4±5.5 ## ]]> Example 2 <![CDATA[269.2±11.0 ## ]]> <![CDATA[69.0±6.6 ## ]]> Example 3 <![CDATA[267.7±9.7 ## ]]> <![CDATA[68.6±6.0 ## ]]> Example 4 <![CDATA[257.4±10.7 ## ]]> <![CDATA[66.8±4.8 ## ]]> Example 5 <![CDATA[261.6±9.6 ## ]]> <![CDATA[67.1±5.4 ## ]]> Example 6 <![CDATA[265.0±10.3 ## ]]> <![CDATA[68.2±3.9 ## ]]> Example 7 <![CDATA[268.5±11.3 ## ]]> <![CDATA[68.5±4.5 ## ]]> Comparative Example 1 <![CDATA[240.6±8.1 △ ]]> <![CDATA[59.9±5.3 △△ ]]> Comparative Example 2 <![CDATA[232.7±8.3 △△ ]]> <![CDATA[58.8±6.2 △△ ]]> Comparative Example 3 <![CDATA[246.8±7.8 △ ]]> <![CDATA[60.1±3.5 △△ <!-- 8 -->]]> Comparative Example 4 <![CDATA[244.2±10.1 △ ]]> <![CDATA[60.3±4.4 △△ ]]> Comparative Example 5 <![CDATA[246.1±12.0 △ ]]> <![CDATA[62.3±5.2 △ ]]> Comparative Example 6 <![CDATA[250.3±9.5 # ]]> <![CDATA[63.4±4.9 △ ]]>

[0147] In Table 1, # P<0.05, ## P<0.01, there are significant differences between the experimental groups and the control group; △ P<0.05, △△ P<0.01, there is a significant difference between the comparative example group and the example 1 group;

[0148] As can be seen from Table 1, the composition of the present invention can significantly improve HC 50 and the number of hemolytic plaques, which were significantly different from those of the comparative composition in terms of replenishing qi and blood and enhancing immunity.

[0149] After the raw material components of the compositions of Comparative Examples 1 to 3 were changed, the synergistic effect between the compositions was destroyed due to the differences in the components, and the immune effect was significantly reduced; especially since there were only 4 components in Comparative Example 1 and only 4 components in Comparative Example 2, even if the effects were added together, the effect brought by the 8 ingredients as a whole could not be achieved.

[0150] After the composition of Comparative Example 4 changes the weight ratio of the components, HC 50 and the number of hemolytic plaques was significantly reduced; after the preparation method of the Dendrobium extract was changed in Comparative Examples 5 and 6, the active components of the Dendrobium extract were changed, thereby affecting HC 50 and the number of hemolytic plaques.

[0151] Experiment 2: Testing the effects of aiding sleep and improving memory

[0152] Experimental animals: Wild-type AB zebrafish were raised, spawned, and managed according to the management methods of zebrafish in the Zebrafish Book. The experiment selected 18-month-old zebrafish from the same batch and placed in a centralized zebrafish independent circulating water system. The water temperature was maintained at around 28.5°C, pH = 7, and the light and dark conditions were set to 14 hours of light (9:00-23:00 daily) and 10 hours of darkness (23:00 pm-9:00 am the next day). They were fed twice a day with brine shrimp and fish feed. The feeding and management of zebrafish were implemented in accordance with the Regulations on the Management of Laboratory Animals of the People's Republic of China.

[0153] Experimental animal grouping and modeling: The experiment selected the same batch of normal aged zebrafish, and after 7 days of adaptive feeding, they were randomly divided into blank control group, model group, Example 1 group, Example 2 group, Example 3 group, Example 4 group, Example 5 group, Example 6 group, Example 7 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, Comparative Example 5 group and Comparative Example 6 group, a total of 15 groups, 21 zebrafish in each group.

[0154] The blank control group was maintained in a normal feeding with a 14-hour light and 10-hour dark cycle; the other experimental groups were given continuous light for 3 consecutive days to establish a sleep deprivation model; at the same time, the example group and the comparative example group were immersed in a solution containing the composition, and half of the solution in each group was replaced daily, and a new solution was added to clean the turbidity in the fish tank.

[0155] In the feeding solutions of the example group and the comparative example group, the concentration of the composition was 200 mg / L.

[0156] Experimental method: After the light exposure, each group of zebrafish was tested for sleep behavior and learning and memory ability. Six zebrafish were randomly selected from each group for sleep behavior testing, and the remaining 15 zebrafish were tested for learning and memory ability.

[0157] (1) Sleep behavior detection

[0158] During the experiment, six zebrafish were placed in six fish tanks with a diameter of 7 cm. Fish water was added to the tanks to 1 / 2 of the height of the tanks. The zebrafish could move freely in the tanks. The camera system on the behavioral analysis system automatically tracked and analyzed the movement of the zebrafish for 48 hours. After the 48-hour tracking, the resting time and total movement distance of the zebrafish were recorded.

[0159] (2) Learning and memory ability test

[0160] The learning and memory ability of zebrafish was observed using the zebrafish T-maze behavioral tracking system. The T-maze consists of horizontally equal left and right arms and a vertical corridor. The maze depth is 10 cm and the filling height is 8 cm. In the middle arm of the maze, a 10 cm × 10 cm × 10 cm area is closed to form a start box. Three partitions of appropriate size are used to separate the start box, left arm and right arm of the maze. In the T-maze test, zebrafish only received food during daily training, and the right arm was connected to the nutrient enrichment (EC) area. The T-maze test was performed according to the literature method (article published by Benvenutti R et al.). The day before the test, the zebrafish was given a 2-hour adaptation period to allow them to move freely in the T-maze to reduce the interference of the new environment on the behavior of the zebrafish.

[0161] On the day of the test, the zebrafish to be tested was placed in the start box and given 30 seconds to adapt to the new environment in the start box. After the adaptation period, the start box baffle was removed. The fish was allowed to move freely in the T maze, and the latency time from the starting point to the EC area was observed and recorded (when the fish found and stayed for 30 seconds, it was considered to have entered the EC area). The test time was 6 minutes. For zebrafish that did not find the EC area, they were guided to enter the EC area and stay for 30 seconds after 6 minutes. The intervention lasted for 3 days, and the latency time of the zebrafish entering the EC area was recorded after 3 days of intervention.

[0162] The results of zebrafish resting time, total movement distance, and latency time to enter the EC area are shown in Table 2 .

[0163] Table 2

[0164] Total resting time (s) Total movement distance (mm) Latent time to enter EC area (s) Blank control group <![CDATA[115972±10665 ☆☆ ]]> <![CDATA[126584±25915 ☆☆ ]]> <![CDATA[58.17±25.05 ☆☆ ]]> Model Group <![CDATA[88521±8735 ## ]]> <![CDATA[168997±30523 ## ]]> <![CDATA[167.51±58.17 ## ]]> Example 1 <![CDATA[129588±11282 ☆☆ ]]> <![CDATA[95623±9907 ☆☆ ]]> <![CDATA[60.28±31.52 ☆☆ ]]> Example 2 <![CDATA[128542±9824 ☆☆ ]]> <![CDATA[99829±7885 #☆☆ ]]> <![CDATA[62.57±27.56 ☆☆ ]]> Example 3 <![CDATA[126541±9757 ☆☆ ]]> <![CDATA[102547±10146 #☆☆ ]]> <![CDATA[62.65±19.58 ☆☆ ]]> Example 4 <![CDATA[117529±9660 ☆☆ ]]> <![CDATA[109826±9735 #☆☆ ]]> <![CDATA[64.13±26.97 ☆☆ ]]> Example 5 <![CDATA[122032±9328 ☆☆ ]]> <![CDATA[107369±9684 #☆☆ ]]> <![CDATA[63.47±24.14 ☆☆ ]]> Example 6 <![CDATA[125000±10119 ☆☆ ]]> <![CDATA[101698±9227 #☆☆ ]]> <![CDATA[61.98±30.85 ☆☆ ]]> Example 7 <![CDATA[127504±8537 ☆☆ ]]> <![CDATA[101536±10205 #☆☆ ]]> <![CDATA[62.05±29.30 ☆☆ ]]> Comparative Example 1 <![CDATA[103550±8641 #☆△△ ]]> <![CDATA[143525±26712 #☆△ ]]> <![CDATA[115.76±28.83 ##☆△△ ]]> Comparative Example 2 <![CDATA[95968±11725 #☆△△ ]]> <![CDATA[149894±21480 #☆△ ]]> <![CDATA[132.42±33.69 ##☆△△ ]]> Comparative Example 3 <![CDATA[110013±12067 ☆△ ]]> <![CDATA[136068±22831 ☆△ ]]> <![CDATA[90.57±34.70 #☆△ ]]> Comparative Example 4 <![CDATA[109326±9953 ☆△ ]]> <![CDATA[136987±23622 ☆△ ]]> <![CDATA[95.07±38.12 #☆△ ]]> Comparative Example 5 <![CDATA[110588±10290 ☆△ ]]> <![CDATA[128290±5564 ☆☆△ ]]> <![CDATA[85.18±25.34 ☆☆△ ]]> Comparative Example 6 <![CDATA[115064±9199 ☆△ ]]> <![CDATA[120564±12339 ☆☆△ ]]> <![CDATA[79.85±19.65 ☆☆△ ]]>

[0165] In Table 2, # P<0.05, ## P<0.01, there are significant differences between each experimental group and the blank control group; ☆ P<0.05, ☆☆ P<0.01, there are significant differences between each experimental group and the model group; △ P<0.05, △△ P<0.01, there is a significant difference between the comparative example group and the example 1 group.

[0166] As can be seen from Table 2, the composition of the present invention can significantly increase the resting time, reduce the total movement distance, and reduce the latency time to enter the EC area; the composition of the present invention has a significant effect on improving the movement behavior of sleep-deprived zebrafish and improving learning and memory.

[0167] After the raw material components of the compositions of Comparative Examples 1 to 3 were changed, the sleep improvement and learning memory effects were significantly reduced; in particular, there were only 4 components in Comparative Example 1 and only 4 components in Comparative Example 2. Even if the effects were added together, they still could not achieve the specific improvement effect brought about by the composition of the present invention with 8 components as a whole.

[0168] After the composition of Comparative Example 4 changed the weight ratio of the components, although it had a certain effect of improving sleep and memory, it was still significantly different from the effect of the composition of the present invention. Comparative Examples 5 and 6 changed the preparation method of Dendrobium extract to affect the resting time, total movement distance and latency time of entering the EC zone of zebrafish

[0169] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A composition for replenishing qi and blood, promoting sleep, and improving memory, characterized in that: The raw material components include, by weight: 5-50 parts of astragalus, 5-30 parts of angelica, 5-25 parts of hawthorn, 1-15 parts of tangerine peel, 5-40 parts of mulberry, 5-25 parts of malt, 1-15 parts of dendrobium and 1-25 parts of American ginseng.

2. The composition according to claim 1, characterized in that The raw material components include, by weight: 12-20 parts of astragalus, 8-15 parts of angelica, 12-20 parts of hawthorn, 8-12 parts of tangerine peel, 13-16 parts of mulberry, 12-20 parts of malt, 8-12 parts of dendrobium and 13-20 parts of American ginseng.

3. The composition according to claim 2, characterized in that In terms of weight, the raw material components include: 16 parts of astragalus, 12 parts of angelica, 15 parts of hawthorn, 10 parts of tangerine peel, 14 parts of mulberry, 15 parts of malt, 10 parts of dendrobium and 16 parts of American ginseng.

4. A method for preparing the composition according to any one of claims 1 to 3, characterized in that: Includes steps: (1) Preparing a dendrobium extract: boiling the dendrobium with water to obtain a decoction mixture; after the decoction mixture is cooled, adding a composite enzyme for enzymolysis to obtain a dendrobium extract; the composite enzyme is cellulase and pectinase; (2) soaking astragalus, angelica, malt and ginseng in water, ultrasonically treating, decocting and filtering to obtain filtrate 1 and residue 1; (3) Mix the residue 1 with hawthorn, tangerine peel and mulberry, continue to add water for decoction, filter and obtain filtrate 2; (4) combining filtrate 1 and filtrate 2, concentrating and drying to obtain a mixture; and mixing the mixture with the dendrobium officinale extract to obtain a composition.

5. The preparation method according to claim 4, characterized in that: In step (1), the solid-liquid ratio of the decoction is 1:8-20 g / mL, and the decoction is performed for 1-3 hours; and the cooling temperature is 38-45°C.

6. The preparation method according to claim 4, characterized in that: In step (1), the mass ratio of the cellulase to the pectinase is 1:1.2-5; and the added amount of the complex enzyme is 1-3 mg complex enzyme / 50-300 mg dendrobium.

7. The preparation method according to claim 4, characterized in that: In step (1), the enzymatic hydrolysis temperature is 38-45°C, and the enzymatic hydrolysis time is 18-48h.

8. The preparation method according to claim 4, characterized in that: In step (2), the solid-liquid ratio of the water-added soaking is 1:8-20 g / mL, the ultrasonic treatment time is 0.5-2 h, and the decoction time is 0.5-2 h; In step (3), the solid-liquid ratio of the decoction is 1:6-15 g / mL, and the decoction is performed for 1-3 hours.

9. Use of a composition in the preparation of a medicine having the effects of replenishing qi and blood, promoting sleep, and improving memory, characterized in that: The composition is the composition according to any one of claims 1 to 3 or the composition prepared by the preparation method according to any one of claims 4 to 8.

10. A medicine having the effects of replenishing qi and blood, promoting sleep, and improving memory, characterized in that: The invention comprises components: the composition according to any one of claims 1 to 3 or the composition prepared by the preparation method according to any one of claims 4 to 8.