A medicinal and edible composition for replenishing qi and blood and its preparation method and use

Abstract

The present invention belongs to the field of medicine and food formula and application, and specifically relates to a medicine and food composition for invigorating qi and clearing the heart, and a preparation method and use thereof. The medicine and food composition is derived from the textual research and modification of the Tongren Niuhuang Qingxin Pill formula, and is composed of 18 medicinal materials including yam, jujube, donkey-hide gelatin, malt, coix seed, Euryale ferox, Poria, dried ginger, cinnamon, bergamot, citron, mint, licorice, angelica dahurica, gardenia, dandelion, platycodon and fried bitter almond. The composition has the effects of invigorating qi, strengthening the spleen and clearing the heart. The present invention utilizes modern preparation technology and is designed and optimized, and the preparation method has a stable process.

Description

Technical Field

[0001] The invention belongs to the field of medicine-food homologous formula and application, and specifically relates to a qi-invigorating and heart-clearing medicine-food homologous composition and a preparation method and application thereof. Background Art

[0002] The pace of modern society is accelerating, and people's life pressure is increasing. Bad habits such as overthinking, staying up late, and eating spicy food have damaged the spleen and stomach of modern people, weakened their immunity, and made them prone to qi and blood deficiency, namely "qi deficiency" and "blood deficiency" in traditional Chinese medicine. The specific manifestations are poor disease resistance, chills, cold limbs, dizziness, tinnitus, mental depression, fatigue, palpitations, shortness of breath, dull or pale complexion, dry skin, withered hair, cracked nails, blurred vision, numbness of hands and feet, insomnia, forgetfulness, palpitations, mental confusion, and irritability. At present, the drugs / health products on the market for such symptoms mainly include tea drinks, oral liquids, etc., with simple formulas, unobvious efficacy, and serious homogeneity. Summary of the invention

[0003] In order to solve the problem that the existing food and medicine products with the effects of invigorating qi and clearing the heart are insufficient or have poor therapeutic effects, the present invention provides a food and medicine composition that invigorates qi and clears the heart, and a preparation method and use thereof, providing a new idea for clinically improving qi deficiency and blood deficiency.

[0004] Specifically, the present invention is realized from the following technical contents:

[0005] In the first aspect, the present invention provides a medicinal and edible composition for invigorating qi and clearing the heart, comprising the following raw materials in parts by weight: 50-60 parts of yam, 20-40 parts of jujube, 10-20 parts of donkey-hide gelatin, 15-30 parts of malt, 5-20 parts of coix seeds, 5-20 parts of Euryale ferox, 8-20 parts of poria, 4-12 parts of dried ginger, 8-20 parts of cinnamon, 2-10 parts of bergamot, 2-10 parts of citron, 2-10 parts of mint, 30-50 parts of licorice, 8-20 parts of angelica dahurica, 8-20 parts of gardenia, 4-12 parts of dandelion, 5-15 parts of platycodon, and 5-15 parts of fried bitter almonds.

[0006] The above-mentioned qi-invigorating and heart-clearing medicinal and edible composition preferably comprises the following raw materials in parts by weight: 52-58 parts of yam, 25-35 parts of jujube, 12-17 parts of donkey-hide gelatin, 18-23 parts of malt, 8-13 parts of coix seed, 8-13 parts of Euryale ferox, 10-16 parts of Poria, 4-8 parts of dried ginger, 10-16 parts of cinnamon, 2-10 parts of bergamot, 2-10 parts of citron, 2-10 parts of mint, 37-45 parts of licorice, 8-14 parts of angelica, 8-14 parts of gardenia, 3-8 parts of dandelion, 6-12 parts of platycodon, and 6-12 parts of fried bitter almonds.

[0007] The above-mentioned qi-invigorating and heart-clearing medicinal and edible composition, most preferably, comprises the following raw materials in parts by weight: 56 parts of yam, 30 parts of jujube, 14 parts of donkey-hide gelatin, 20 parts of malt, 10 parts of coix seed, 10 parts of Euryale ferox, 12 parts of Poria, 6 parts of dried ginger, 14 parts of cinnamon, 4 parts of bergamot, 4 parts of citron, 4 parts of mint, 40 parts of licorice, 12 parts of angelica dahurica, 12 parts of gardenia, 6 parts of dandelion, 9 parts of platycodon, and 9 parts of fried bitter almonds.

[0008] In a second aspect, the present invention provides a method for preparing the above-mentioned Qi-invigorating and heart-clearing medicinal and edible composition, comprising the following steps:

[0009] Step 1: Extraction: Take yam, jujube, donkey-hide gelatin, malt, coix seed, Euryale ferox, Poria, dried ginger, cinnamon, bergamot, citron, mint, licorice, angelica dahurica, gardenia, dandelion, platycodon, and fried bitter almonds, add 6 to 10 times the amount of water to the 18 medicinal materials, soak at room temperature for 10 to 60 minutes, heat to boiling, extract 2 to 3 times, the extraction time is 0.5 to 2 hours, filter, and combine to obtain an extract;

[0010] Step 2: Concentration: The extract is concentrated at normal pressure to a relative density of 1.00 to 1.25 at 20°C to obtain an extract;

[0011] Step 3: Drying: The extract is dried under reduced pressure, with a vacuum degree of 0.08-0.095 MPa, a temperature of 50-80°C, and a drying time of 20-30 hours, until the moisture content is less than 5%, and then crushed and passed through a 200-mesh sieve to obtain a dry extract powder;

[0012] Step 4: Granulation: add appropriate amount of excipients and wetting agents, wet granulate, dry at 50-60℃ for 1h, and granulate to obtain;

[0013] The excipients include but are not limited to soluble starch, dextrin and the like.

[0014] The wetting agent includes but is not limited to 70-90% ethanol.

[0015] In a third aspect, the present invention provides a medicinal and edible composite preparation for invigorating qi and clearing the heart, wherein the preparation is prepared by the composition described in the first aspect or the composition prepared by the preparation method described in the second aspect alone, or by mixing the composition described in the first aspect or the composition prepared by the preparation method described in the second aspect with a pharmaceutically acceptable carrier.

[0016] The pharmaceutically acceptable carrier refers to a conventional drug carrier in the field of pharmaceutical preparations, selected from one or more of fillers, binders, disintegrants, lubricants, suspending agents, wetting agents, pigments, flavoring agents, solvents, and surfactants.

[0017] In a fourth aspect, the present invention provides use of the composition described in the first aspect above, or the composition prepared by the preparation method described in the second aspect above, or the composition preparation described in the third aspect above in preparing products for improving qi deficiency and blood deficiency.

[0018] As an optional mode, in the above-mentioned use, the use is for improving low immunity.

[0019] As an option, in the above use, the product is a medicine, a health product or a functional food.

[0020] As an option, in the above use, the dosage form of the product includes traditional dosage forms (eg, pills, powders, pastes, pills) and modern preparations (eg, granules, tablets, oral liquids or capsules).

[0021] As an optional mode, in the above-mentioned use, the dosage form of the product is granules.

[0022] The medicinal properties and effects of the Chinese medicinal raw materials used in the present invention are as follows:

[0023] Chinese Yam: sweet, neutral. Enters the spleen, lung, and kidney meridians. Nourishes the spleen and stomach, promotes the production of body fluids and benefits the lungs, and nourishes the kidneys and astringes semen. Used for spleen deficiency, poor appetite, chronic diarrhea, asthma and cough due to lung deficiency, spermatorrhea due to kidney deficiency, leucorrhea, frequent urination, and thirst due to deficiency heat.

[0024] Jujube: sweet, warm. Enters the spleen, stomach, and heart meridians. Replenishes qi, nourishes blood, and calms the mind. Used for spleen deficiency, poor appetite, fatigue, loose stools, and irritability in women.

[0025] Donkey-hide gelatin: sweet, warm. Enters the spleen, stomach, and heart meridians. Replenishes qi, nourishes blood, and calms the mind. Used for spleen deficiency, poor appetite, fatigue, loose stools, and irritability in women.

[0026] Malt: sweet, neutral. Enters the spleen and stomach meridians. Promotes qi and digestion, invigorates the spleen and stimulates appetite, and relieves bloating. Used for indigestion, abdominal distension and pain, spleen deficiency and loss of appetite, milk stagnation, breast pain, weaning in women, liver depression and flank pain, liver and stomach qi pain. Raw malt invigorates the spleen and harmonizes the stomach, soothes the liver and promotes qi. Used for spleen deficiency and loss of appetite, milk stagnation.

[0027] Coix seeds: sweet, light, cool. Enter the spleen, stomach, and lung meridians. It can promote diuresis and eliminate dampness, strengthen the spleen and stop diarrhea, remove numbness, discharge pus, detoxify and disperse stagnation. It is used for edema, beriberi, dysuria, spleen deficiency diarrhea, dampness and stiffness, lung abscess, intestinal abscess, warts, and cancer.

[0028] Gorgon Fruit: sweet, astringent, neutral. Enters the spleen and kidney meridians. Nourishes the kidney and strengthens the essence, tonifies the spleen and stops diarrhea, removes dampness and stops leukorrhea. Used for spermatorrhea, nocturnal emission, frequent urination, chronic diarrhea due to spleen deficiency, leukorrhea, and leukorrhea.

[0029] Poria: sweet, light, neutral. Enters the heart, lung, spleen, and kidney meridians. It promotes diuresis and eliminates dampness, strengthens the spleen, and calms the mind. It is used for edema, oliguria, phlegm and fluid, palpitations, spleen deficiency, poor appetite, loose stools, restlessness, palpitations, and insomnia.

[0030] Dried ginger: pungent, hot. Enters the spleen, stomach, kidney, heart, and lung meridians. Warms the middle and dispels cold, restores yang and unclogs the meridians, warms the lungs and transforms fluid. Used for cold pain in the abdomen, vomiting and diarrhea, cold limbs and weak pulse, asthma and cough due to cold fluid.

[0031] Cinnamon: pungent, sweet, very hot. Enters the kidney, spleen, heart, and liver meridians. Replenishes fire and yang, guides fire back to the origin, dispels cold and relieves pain, warms and dredges the meridians. Used for impotence, cold uterus, cold pain in the waist and knees, asthma due to kidney deficiency, floating of false yang, dizziness and red eyes, cold pain in the heart and abdomen, vomiting and diarrhea due to deficiency and cold, abdominal pain due to cold hernia, dysmenorrhea and amenorrhea.

[0032] Citron: pungent, bitter, sour, warm. Enters the liver, spleen, stomach, and lung meridians. Soothes the liver and regulates qi, harmonizes the stomach and relieves pain, dries dampness and resolves phlegm. Used for liver and stomach qi stagnation, chest and flank pain, fullness in the stomach, loss of appetite and vomiting, and cough with excessive phlegm.

[0033] Citron: pungent, bitter, sour, warm. Enters the liver, spleen, and lung meridians. Soothes the liver and regulates qi, relieves fullness, and resolves phlegm. Used for liver and stomach qi stagnation, chest and flank pain, abdominal distension, vomiting, belching, and cough with excessive phlegm.

[0034] Peppermint: pungent, cool. Enters the lung and liver meridians. Disperses wind-heat, clears the head and eyes, relieves sore throat, clears rashes, soothes the liver and promotes qi. Used for wind-heat cold, initial onset of wind-heat, headache, red eyes, throat paralysis, mouth sores, rubella, measles, chest and flank distension.

[0035] Licorice: sweet, neutral. Enters the heart, lung, spleen, and stomach meridians. It nourishes the spleen and replenishes qi, clears away heat and detoxifies, removes phlegm and relieves cough, relieves pain, and harmonizes various medicines. It is used for spleen and stomach weakness, fatigue, palpitations and shortness of breath, cough with sputum, abdominal and limb cramps and pain, carbuncle, sore and ulcer, and relieves drug toxicity and potency.

[0036] Angelica dahurica: pungent, warm. Enters the stomach, large intestine, and lung meridians. Relieves cold, dispels wind and relieves pain, clears the nasal passages, dries dampness and stops leukorrhea, and reduces swelling and discharges pus. Used for colds and headaches, brow pain, nasal congestion and runny nose, allergic rhinitis, sinusitis, toothache, leukorrhea, and sores and swelling.

[0037] Gardenia: bitter, cold. Enters the heart, lung, and triple burner meridians. It can relieve heat and relieve restlessness, clear away heat and dampness, cool blood and detoxify; externally used to reduce swelling and relieve pain. It is used for restlessness due to febrile diseases, jaundice due to dampness and heat, astringent pain due to stranguria, vomiting and bleeding due to blood heat, red and swollen eyes, and fire poison sores; external treatment of sprains and contusions.

[0038] Taraxacum: bitter, sweet, cold. Enters the liver and stomach meridians. Clears away heat and detoxifies, reduces swelling and resolves stagnation, promotes diuresis and relieves stranguria. Used for carbuncle, breast carbuncle, scrofula, red eyes, sore throat, lung carbuncle, intestinal carbuncle, damp-heat jaundice, and painful stranguria caused by heat.

[0039] Platycodon grandiflorum: bitter, pungent, neutral. Enters the lung meridian. Clears the lungs, relieves sore throat, removes phlegm, and discharges pus. Used for cough with a lot of phlegm, chest tightness, sore throat, hoarseness, and lung abscess with pus.

[0040] Fried bitter almonds: slightly warm; slightly toxic. Enter the lung and large intestine meridians. It can lower qi, relieve cough and asthma, moisten the intestines and promote bowel movements. It is used for cough and asthma, chest fullness and phlegm, dry intestines and constipation.

[0041] Compared with the prior art, the present invention has the following beneficial effects:

[0042] The invigorating qi and clearing heart medicine and food homologous composition of the present invention has the effects of invigorating qi, strengthening spleen and clearing heart, and can be used to treat qi and blood deficiency by clearing and replenishing. In addition, the present invention is based on the traditional medicine formula, and uses modern preparation technology to design and optimize, and the preparation method of the present invention is stable. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] Figure 1 Effect of extraction process on total solid yield. (a) Effect of different extraction times on total solid yield, (b) Effect of different extraction time on total solid yield, (c) Effect of different water ratio on total solid yield.

[0044] Figure 2 Extraction process design space (the bright yellow part is the design space, the dark yellow part is the confidence interval, and the gray part is outside the design space).

[0045] Figure 3 The effect of single factor of granulation process on granulation rate. (a) The effect of different drug-excipient ratio on granulation rate, (b) The effect of different ethanol concentration on granulation rate, (c) The effect of different ethanol dosage on granulation rate.

[0046] Figure 4 Granulation process design space (the bright yellow part is the design space, the dark yellow part is the confidence interval, and the gray part is outside the design space).

[0047] Figure 5 Yiqi Qingxin Granule IC 50 (24h).

[0048] Figure 6 Statistical graph of fluorescence intensity of zebrafish neutrophils in each experimental group. (C is the blank group, DMSO is the solvent group, M is the model group, YQQX is the Yiqi Qingxin Granule group, BZYQ is the Buzhong Yiqi Pill-positive drug control group, and GLSY is the Korean ginseng beverage-positive drug control group).

[0049] Figure 7 Schematic diagram of the fluorescence intensity of zebrafish neutrophils in each experimental group. (C is the blank group, DMSO is the solvent group, M is the model group, YQQX is the Yiqi Qingxin Granule group, BZYQ is the Buzhong Yiqi Pill-positive drug control group, and GLSY is the Korean ginseng beverage-positive drug control group).

[0050] Figure 8Statistical graph of zebrafish heart red blood cell staining area in each experimental group. (C is the blank group, M is the model group, Y is the Yiqi Qingxin Granule group, and H is the ferrous succinate tablet-positive drug control group).

[0051] Fig. 9 Schematic diagram of zebrafish heart red blood cell staining area in each experimental group. (C is the blank group, M is the model group, Y is the Yiqi Qingxin Granule group, and H is the ferrous succinate tablet-positive drug control group). DETAILED DESCRIPTION

[0052] The formula analysis of the Chinese medicine composition of the present invention is as follows:

[0053] The main medicines are yam, jujube, and donkey-hide gelatin, which nourish the lungs, spleen, kidneys and three burners, replenish qi, nourish blood, and nourish yin; the auxiliary medicines are poria, malt, coix seed, and Euryale ferox, which strengthen the spleen and stomach; dried ginger and cinnamon, warm the middle and dispel cold; bergamot, citron, and mint, soothe the liver and replenish qi, and regulate emotions; the auxiliary medicines are angelica, gardenia, and dandelion, which consolidate the exterior, clear heat and relieve restlessness; platycodon and bitter almond, eliminate phlegm and promote qi movement; and licorice harmonizes all the medicines.

[0054] Furthermore, the advantages of the formula were preliminarily evaluated through zebrafish Qi deficiency experiments.

[0055] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the embodiments described are only some representative embodiments of the present invention, rather than all embodiments. All other embodiments obtained by ordinary technicians in this field without making creative work belong to the protection scope of the present invention.

[0056] Example 1: Evaluation of the advantages of the Yiqi Qingxin Granules formulation based on the zebrafish Qi deficiency model (1) Sample preparation

[0057] Whole prescription group: 56g yam, 30g jujube, 14g donkey-hide gelatin, 20g malt, 10g coix seed, 10g Euryale ferox, 12g poria, 6g dried ginger, 14g cinnamon, 4g bergamot, 4g citron, 4g mint, 40g licorice, 12g angelica, 12g gardenia, 6g dandelion, 9g platycodon, and 9g fried bitter almond.

[0058] The main and auxiliary medicine group: yam 56g, jujube 30g, donkey-hide gelatin 14g, coix seed 10g, Euryale ferox 10g, Poria 12g, dried ginger 6g, cinnamon 14g, bergamot 4g, citron 4g, mint 4g.

[0059] Auxiliary drug group: licorice 40g, angelica dahurica 12g, gardenia 12g, dandelion 6g, platycodon 9g, and stir-fried bitter almond 9g.

[0060] The main medicine reduction group: yam 14g, jujube 30g, donkey-hide gelatin 14g, malt 20g, coix seed 10g, Euryale ferox 10g, Poria 12g, dried ginger 6g, cinnamon 14g, bergamot 4g, citron 4g, mint 4g, licorice 40g, angelica 12g, gardenia 12g, dandelion 6g, platycodon 9g, and stir-fried bitter almond 9g.

[0061] Main medicine replacement group: 56g of yam, 30g of astragalus, 14g of donkey-hide gelatin, 20g of malt, 10g of coix seed, 10g of Euryale ferox, 12g of Poria, 6g of dried ginger, 14g of cinnamon, 4g of bergamot, 4g of citron, 4g of mint, 40g of licorice, 12g of angelica, 12g of gardenia, 6g of dandelion, 9g of platycodon, and 9g of fried bitter almond.

[0062] The preparation method of the above-mentioned traditional Chinese medicine composition is water extraction, 10 times the amount of water, extraction once, extraction time 2h, collecting the extract, and concentrating the volume to 1L.

[0063] (2) Solution preparation

[0064] 100 μg / mL vinorelbine solution: Accurately weigh some vinorelbine standard, dissolve it in DMSO to obtain 100 mg / mL vinorelbine stock solution, dilute it to 100 μg / mL (DMSO content is 0.1%) with zebrafish embryo culture medium, store it at 4°C, and preheat it to about 28.5°C before use.

[0065] 0.1% DMSO culture medium: Take some DMSO solvent, dilute it to 0.1% with zebrafish embryo culture medium, store it at 4°C, and preheat it to about 28.5°C before use.

[0066] Anesthetic: Weigh an appropriate amount of tricaine, dissolve it in zebrafish embryo culture medium to obtain an anesthetic with a concentration of 0.5%, and store it at 4°C.

[0067] (3) Zebrafish embryo culture

[0068] The culture was carried out in accordance with the relevant regulations of the National Zebrafish Resource Center. The embryonic development temperature of AB wild-type zebrafish was 28.5°C, the dark time: light time was 10h:14h, the light intensity was 54-324lux, the medium was changed daily, and the shed fetal membranes or dead embryos were cleaned up.

[0069] (4) Construction of Qi deficiency model and drug efficacy verification

[0070] Normally developed zebrafish embryos at 2 to 3 dpf after fertilization were selected and randomly transferred into 12-well plates, with 10 to 15 zebrafish in each well.

[0071] Efficacy comparison: The whole prescription group, monarch and ministerial drug group, adjuvant and envoy drug group, monarch drug reduction group, and monarch drug replacement group were set up. The blank group was given zebrafish embryo culture medium, and the other groups were given 100 μg / mL vinorelbine solution. Each group had 3 replicates, and the dosage in each well was 3.0 mL. The cells were placed in an incubator for 24 hours to construct a Qi deficiency model.

[0072] After the reaction, the blank group and the solvent group were replaced with corresponding solutions, and the other groups were washed three times with zebrafish embryo culture medium, replaced with corresponding drugs, and continued to be placed in the incubator for drug intervention for 12 hours.

[0073] (5) Neutrophil fluorescence intensity detection

[0074] After the drug intervention, the cells were washed three times with zebrafish embryo culture medium to remove the drugs.

[0075] The zebrafish were sucked into the anesthetic and allowed to stand for 3-5 min. The fry were sucked out and placed on a biconcave glass slide in an upright position under a fluorescence microscope to collect images of the whole fish.

[0076] Image J image processing software was used to count the neutrophils in the area from the end of the yolk sac to the tail.

[0077] (6) Study on the advantages of the Yiqi Qingxin granules formula

[0078] After intervention with the extract of the Yiqi Qingxin full prescription, the fluorescence intensity of zebrafish neutrophils increased significantly compared with the model group (P<0.0001), indicating that the Yiqi Qingxin prescription has a significant effect of replenishing qi; the monarch and minister drugs are the drugs with the main effects of soothing the liver and replenishing qi in the prescription, which is reflected in the significant increase in the fluorescence intensity of zebrafish neutrophils in the monarch and minister drug group compared with the model group (P<0.001); the assistant drug is the drug for consolidating the exterior, clearing heat and harmonizing the full prescription in the prescription, which plays an auxiliary medication and harmonizing role, which is reflected in the fact that the fluorescence intensity of zebrafish neutrophils in the assistant drug group has no significant change compared with the model group. This shows that the formula in the present invention is excellent.

[0079] In order to further demonstrate the importance of the main drug in the formula, the main drug reduction and main drug replacement groups were set up. From the results in Table 1, it can be seen that changing the drug ratio in the formula of the present invention or replacing it with a drug with similar function will lead to varying degrees of reduction in the qi-invigorating effect, further illustrating that the formula protected by the present invention is excellent.

[0080] Table 1 Qi-tonifying effects of relevant extracts of Yiqi Qingxin Recipe

[0081]

[0082] The present invention is further described with reference to examples. The examples are only intended to illustrate the present invention, but not to limit the present invention.

[0083] If no specific techniques or conditions are specified in the examples, the techniques or conditions described in the literature in the field or the product instructions are used. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0084] The experimental methods in the following examples are conventional methods unless otherwise specified. The experimental materials used in the following examples are commercially available products unless otherwise specified.

[0085] Example 2: Preparation method of Yiqi Qingxin granules

[0086] 1. Determination of extraction process

[0087] (1) Preparation of medicinal materials

[0088] Weigh 28 g of yam, 15 g of jujube, 7 g of donkey-hide gelatin, 7 g of malt, 10 g of coix seed, 5 g of Euryale ferox, 5 g of Poria, 3 g of dried ginger, 7 g of cinnamon, 2 g of bergamot, 2 g of citron, 3 g of mint, 20 g of licorice, 6 g of angelica dahurica, 6 g of gardenia, 3 g of dandelion, 5 g of platycodon, and 5 g of fried bitter almond in a 250 mL flask.

[0089] (2) Process parameter screening

[0090] Based on literature research combined with rank sum ratio analysis, the key process parameters for the extraction process were determined to be the number of extractions, extraction time and water volume.

[0091] (3) Determination of intervals in response surface experimental design based on single factor investigation

[0092] Soak the medicinal materials for 30 min, adjust the volume to 250 mL after extraction, take 25 mL and evaporate to dryness in a water bath, dry at 105°C, weigh, and calculate the total solid yield.

[0093] Determination of the extraction times response surface experimental design interval: solid-liquid ratio 1:8, extraction time 1h, extraction 1, 2, 3, 4, 5 times respectively, determination of total solid yield, parallel 3 times, the results are as follows Figure 1 The total solid yield increases with the number of extractions, and the yield tends to be stable after 3 extractions. Considering the economic cost, the three-level response surface experimental design selects 1-3 times.

[0094] Determination of the extraction time response surface experimental design interval: solid-liquid ratio 1:8, extraction times 2, extraction 0.5, 1, 1.5, 2, 2.5h respectively to determine the total solid yield, parallel 3 times, the results are as follows Figure 1 (b) The total solid yield increases with the increase of extraction time. When the extraction time exceeds 1 h, the total solid yield increases by about 2% for every 0.5 h increase in extraction time. Considering the economic cost, the three-level response surface experimental design selected 0.5-1.5 h.

[0095] Determination of the experimental design interval of water-fold response surface: extraction time 1h, extraction times 2 times, water-fold 6, 8, 10, 12, 14 respectively, total solid yield was measured, parallel 3 times, the results are as follows Figure 1 When the solid-liquid ratio is 6-14 times, the total solid yield is less affected. Considering the economic cost, the three-level response surface experimental design selects 6-10 times.

[0096] (4) Establishment of process design space based on BB response surface design

[0097] Based on the results of (3), a BB experiment was designed, and total solids, total flavonoids content, and total polysaccharide content were selected as response values. The experimental design and results are shown in Table 2.

[0098] Table 2 BB response surface experimental design and statistical results of extraction process

[0099]

[0100] The corresponding regression equations for total solid, total polysaccharide and total flavonoid contents are as follows:

[0101] R1=3.35+0.6187A+0.101B+0.0927C+0.0572AB-0.0307AC-0.0107BC-0.0349A

[0102] 2 +0.0651B 2 +0.0191C 2

[0103] R2=1.94+0.4695A+0.1003B+0.005C-0.2572AB-0.2153AC+0.0702BC-0.201A 2 -0.0455B 2 +0.016C 2

[0104] R3=63.1+12.73A-1.18B+5.58C-0.1923AB+1.13AC-2.57BC-7,85A 2 +2.7B 2 -0.4341C 2

[0105] Further construct the design space, such as Figure 2 shown.

[0106] (5) Determination and verification of optimal process parameters

[0107] According to the analysis results of (4), the optimal process is determined to be 3 extractions, 0.70h extraction, and a solid-liquid ratio of 8.90. Randomly select parameter combinations within the design space, the 95 confidence interval, and outside the interval for verification. Select points such as Figure 2 The results are shown in Table 3, which compares them with the predicted values, proving that the design space is robust.

[0108] Table 3 Design space robustness verification

[0109]

[0110] 2. Determination of drying process

[0111] (1) Extract preparation

[0112] The extract is concentrated by heating at normal pressure, referring to the sample preparation method of the Pharmacopoeia General Chapter 0183 Ointment, that is, take an appropriate amount of the concentrate, weigh it, add 2 times of water, stir it thoroughly, and measure it. The relative density is 1.00-1.25 (20°C).

[0113] (2) Process parameter screening

[0114] Based on literature research, it is determined that the key process parameter to be investigated in the drying process is the drying temperature.

[0115] (3) Single factor study on drying temperature

[0116] Weigh 40.00 g of the concentrate, place it in a glass culture dish with a diameter of 180 mm, spread it flat (thickness 4 mm), set the vacuum degree to -0.080 to -0.095 MPa, set the temperature to 60, 70, 80, and 90° C. respectively, and dry it for 24 hours.

[0117] After drying, take out the glass culture dish and put it into a desiccator for 30 minutes to reach room temperature, collect, fully crush, pass through an 80-mesh sieve, and seal and dry for storage.

[0118] 2.0000 g of the sieved sample was weighed and the moisture content was determined using a rapid moisture meter, repeated 3 times; another 0.50 g of the sieved sample was taken and fully dissolved in deionized water, the volume was fixed to 25 mL, and the total polysaccharide and total flavonoid contents of the dissolved sample were determined. The results are shown in Table 4.

[0119] Table 4 Comprehensive statistics of various indicators of dry paste powder obtained at different temperatures

[0120]

[0121] 3. Determination of granulation process

[0122] (1) Preparation of dry paste powder

[0123] According to the optimal process in the 2 drying processes, dry paste powder is prepared and placed in a dryer for later use.

[0124] (2) Process parameter screening

[0125] Based on literature research, the key process parameters for granulation process are determined to be the type of excipients, drug-excipient ratio, wetting agent concentration and wetting agent dosage.

[0126] (3) Single factor study on excipient type

[0127] Weigh the dry paste powder, according to the drug-excipient ratio of 1:1, the wetting agent is 90% ethanol, the dosage is 0.3mL / g, and the excipients are three common excipients: soluble starch, dextrin, and lactose. Granulate with a 14-mesh sieve, dry at 60℃ for 2h, calculate the molding rate according to the sieving method of the Pharmacopoeia General Chapter 0982, and measure the moisture with a rapid moisture meter. The results are shown in Table 5. Soluble starch is selected as the excipient of Yiqi Qingxin Granules.

[0128] Table 5 Statistics of granulation of different excipients

[0129]

[0130] (4) Determination of intervals in response surface experimental design based on single factor investigation

[0131] Determination of the drug-excipient ratio response surface experimental design interval: The ethanol concentration is fixed at 90% and the dosage is 0.15mL / g. The dosage of granule excipients should not exceed 5 times the amount of clear paste and 2 times the amount of dry paste. Therefore, the single factor investigation gradient of drug-excipient ratio is set to 1:0.5, 1:1:, 1:1.5, 1:2. The results are as follows Figure 3 (a) The three levels of response surface experimental design were drug-excipient ratios of 1:0.5, 1:1:, and 1:1.5.

[0132] Determination of the wetting agent concentration response surface experimental design interval: the drug-excipient ratio is fixed at 1:1, and the ethanol dosage is 0.15mL / g. The single factor gradient of ethanol concentration is set to 75%, 80%, 85%, 90%, and 95%. The results are as follows Figure 3 (b) The soft material produced by 75% ethanol had lumps and some sticky webs, and the granulation of the soft material was laborious, so the three levels of the response surface experimental design were 80%, 85%, and 90%.

[0133] Determination of the response surface experimental design interval for wetting agent dosage: fixed drug-excipient ratio 1:1, ethanol concentration 85%. The single factor gradient of ethanol dosage was set to 0.1, 0.15, 0.2, 0.25, 0.3 mL / g. The results are as follows Figure 3 When the dosage was 0.3 mL / g, the soft material agglomerated and slightly sticky, and granulation was relatively laborious, so the three levels of the response surface experimental design were 0.15, 0.2, and 0.25 mL / g.

[0134] (5) Establishment of process design space based on BB response surface design

[0135] Based on the result of (4), a BB experiment was designed and the one-shot forming rate was selected as the response value. The experimental design and results are shown in Table 6.

[0136] Table 6 BB response surface experimental design and statistical results of granulation process

[0137]

[0138]

[0139] The regression equation of one-time forming rate is as follows:

[0140] R1=82.68+4.05A-11.13B+10.38C+4.86AB+0.5341AC

[0141] Further construct the design space, such as Figure 4 shown.

[0142] (6) Determination and verification of optimal process parameters

[0143] According to the analysis results of (5), the optimal process was determined to be a drug-excipient ratio of 1:1.3, an ethanol concentration of 82%, and a dosage of 0.25 mL / g. Parameter combinations within the design space, the 95 confidence interval, and outside the interval were randomly selected for verification and compared with the predicted values. The results are shown in Table 7, proving that the design space is robust.

[0144] Table 7 Design space robustness verification

[0145]

[0146] The present invention provides the following embodiments for the optimized preparation method:

[0147] Preparation Example Preparation:

[0148] Preparation Example 1: 56g of yam, 30g of jujube, 14g of donkey-hide gelatin, 20g of malt, 10g of coix seed, 10g of Euryale ferox, 12g of Poria, 6g of dried ginger, 14g of cinnamon, 4g of bergamot, 4g of citron, 4g of mint, 40g of licorice, 12g of angelica dahurica, 12g of gardenia, 6g of dandelion, 9g of platycodon, and 9g of stir-fried bitter almonds.

[0149] The preparation method of the composition comprises the following steps:

[0150] Step 1: Add 8.9 times the amount of water to the medicinal material, soak at room temperature for 30 minutes, heat to boiling, extract 3 times, the extraction time is 0.7 hours, filter, and combine to obtain the extract;

[0151] Step 2: The extract in step 1 is concentrated at normal pressure to a relative density of 1.00 to 1.25 (20° C.) to obtain an extract;

[0152] Step 3: The extract in step 2 is dried under reduced pressure, with a vacuum degree of 0.08-0.095 MPa, a temperature of 80°C, and a drying time of 24 hours, until the moisture content is less than 5%, and then crushed and passed through a 200-mesh sieve to obtain a dry extract powder;

[0153] Step 4: Add excipient soluble starch to the dry paste powder in step 3 at a drug-excipient ratio of 1:1.3, spray the wetting agent at a dosage of 0.25 mL / g, the wetting agent is 82% ethanol, wet granulate, dry at 50-60°C for 1 hour, and granulate to obtain the product.

[0154] Preparation Example 2: 52g of yam, 25g of jujube, 12g of donkey-hide gelatin, 18g of malt, 8g of coix seed, 8g of Euryale ferox, 10g of Poria, 4g of dried ginger, 10g of cinnamon, 2g of bergamot, 2g of citron, 2g of mint, 37g of licorice, 8g of angelica, 8g of gardenia, 3g of dandelion, 6g of platycodon, and 6g of stir-fried bitter almonds.

[0155] The preparation method of the composition is the same as that of Preparation Example 1.

[0156] Preparation Example 3: 58g of yam, 35g of jujube, 17g of donkey-hide gelatin, 23g of malt, 13g of coix seed, 13g of Euryale ferox, 16g of Poria, 8g of dried ginger, 16g of cinnamon, 10g of bergamot, 10g of citron, 10g of mint, 45g of licorice, 14g of angelica, 14g of gardenia, 8g of dandelion, 12g of platycodon, and 12g of stir-fried bitter almonds.

[0157] The preparation method of the composition is the same as that of Preparation Example 1.

[0158] Preparation of control example:

[0159] Control example 1: 14g of yam, 30g of jujube, 14g of donkey-hide gelatin, 20g of malt, 10g of coix seed, 10g of Euryale ferox, 12g of Poria, 6g of dried ginger, 14g of cinnamon, 4g of bergamot, 4g of citron, 4g of mint, 40g of licorice, 12g of angelica dahurica, 12g of gardenia, 6g of dandelion, 9g of platycodon, and 9g of stir-fried bitter almond.

[0160] The preparation method of the composition is the same as that of Preparation Example 1.

[0161] Control example 2: 56g of yam, 30g of astragalus, 14g of donkey-hide gelatin, 20g of malt, 10g of coix seed, 10g of Euryale ferox, 12g of Poria, 6g of dried ginger, 14g of cinnamon, 4g of bergamot, 4g of citron, 4g of mint, 40g of licorice, 12g of angelica dahurica, 12g of gardenia, 6g of dandelion, 9g of platycodon, and 9g of stir-fried bitter almond.

[0162] The preparation method of the composition is the same as that of Preparation Example 1.

[0163] Control example 3: 56g of yam, 30g of jujube, 14g of donkey-hide gelatin, 20g of malt, 10g of coix seed, 10g of Euryale ferox, 12g of Poria, 6g of dried ginger, 14g of cinnamon, 4g of bergamot, 4g of citron, 4g of mint, 40g of licorice, 12g of angelica dahurica, 12g of gardenia, 6g of dandelion, 9g of platycodon, and 9g of stir-fried bitter almond.

[0164] Compared with the preparation method of Example 1, the preparation method of the composition is as follows: in step 1, the number of extractions is 1, and the other steps are the same.

[0165] Example 3: Effect of Yiqi Qingxin Granules on Zebrafish Embryonic Development

[0166] (1) Solution preparation

[0167] Zebrafish embryo culture medium: weigh 1462.5 mg of sodium chloride, 242.583 mg of calcium chloride, 63.325 mg of potassium chloride, and 198 mg of magnesium sulfate, add deionized water to dissolve, sonicate for 20 min, transfer to a 500 mL volumetric flask after all dissolved, make up to volume, and obtain 10X zebrafish embryo culture medium, store at 4°C, dilute to 1X with deionized water and preheat to about 28.5°C before use, adjust the pH value to about 7.2 with sodium bicarbonate solution, ensure that the salinity range of the culture medium is 0.25-0.5%, and add 1-2 drops of methylene blue solution per 1L when used.

[0168] Yiqi Qingxin Granule Solution: Weigh Yiqi Qingxin Granule into a 2mL centrifuge tube, dissolve it in embryo culture medium as solvent, and prepare a solution with a concentration of 100mg / mL for later use. During the experiment, dilute it with zebrafish embryo culture medium to the grouping concentration and preheat it to about 28.5℃.

[0169] (2) Zebrafish embryo culture

[0170] The culture was carried out in accordance with the relevant regulations of the National Zebrafish Resource Center. The embryonic development temperature of AB wild-type zebrafish was 28.5°C, the dark time: light time was 10h:14h, the light intensity was 54-324lux, the medium was changed daily, and the shed fetal membranes or dead embryos were cleaned up.

[0171] (3) Drug treatment method

[0172] Normally developed zebrafish embryos at 3 dpf after fertilization were selected and randomly transferred into 12-well plates, with 10 fry in each well. Sample solutions of 1, 2, 4, 5, 10, 20, 50, and 100 mg / mL were administered, with 3 replicate wells set up for each concentration group. The samples were placed in a constant temperature and light incubator under the culture conditions of (2) for 24 h, and the teratogenicity and mortality of the zebrafish were observed.

[0173] (4) Effects of Yiqiqingxin Granules on the Development of Zebrafish Embryos

[0174] After treatment with a concentration of 20-100 mg / mL for 24h, 48h and 72h, all zebrafish embryos were distorted and died. SPSS Statistics 20 statistical analysis software was used to calculate the IC value of Yiqi Qingxin Granules for 24h treatment. 50 is 4.98 mg / mL. The results are as follows Figure 5 shown.

[0175] Example 4: Characterization of the Qi-tonifying Efficacy of Yiqi Qingxin Granules

[0176] (1) Solution preparation

[0177] 100 μg / mL vinorelbine solution: Accurately weigh some vinorelbine standard, dissolve it in DMSO to obtain 100 mg / mL vinorelbine stock solution, dilute it to 100 μg / mL (DMSO content is 0.1%) with zebrafish embryo culture medium, store it at 4°C, and preheat it to about 28.5°C before use.

[0178] 0.1% DMSO culture medium: Take some DMSO solvent, dilute it to 0.1% with zebrafish embryo culture medium, store it at 4°C, and preheat it to about 28.5°C before use.

[0179] Anesthetic: Weigh an appropriate amount of tricaine, dissolve it in zebrafish embryo culture medium to obtain an anesthetic with a concentration of 0.5%, and store it at 4°C.

[0180] Positive control drug culture medium: Select Chinese patent medicine Buzhong Yiqi Pills and health product Korean ginseng beverage as positive control drugs, refer to the solution preparation method of Yiqi Qingxin Granules, and prepare them into 10mg / mL mother solution for standby use. During the experiment, dilute with zebrafish embryo culture medium to the grouping concentration and preheat to about 28.5℃.

[0181] The preparation methods of vinorelbine injection solution, 0.1% DMSO culture medium, anesthetic, zebrafish embryo culture medium and Yiqi Qingxin granule solution are the same as those in Example 1 and Example 3.

[0182] (2) Zebrafish embryo culture

[0183] The zebrafish embryo culture method is the same as in Example 3.

[0184] (3) Construction of Qi deficiency model and drug efficacy verification

[0185] Normally developed zebrafish embryos at 2 to 3 dpf after fertilization were selected and randomly transferred into 12-well plates, with 10 to 15 zebrafish in each well.

[0186] Efficacy verification: a blank group, a solvent group (0.1% DMSO), a model group, a Yiqi Qingxin Granule group, and a positive control drug group (Buzhong Yiqi Pills, Korean ginseng beverage) were set up. The blank group was given zebrafish embryo culture medium, the solvent group was given 0.1% DMSO culture medium, and the other groups were given 100 μg / mL vinorelbine solution. Each group had 5 replicate wells, and the dosage in each well was 3.0 mL. The wells were placed in an incubator for 24 hours to construct a Qi deficiency model.

[0187] Efficacy comparison: a blank group, a model group, a preparation example 1 group, a preparation example 2 group, a preparation example 3 group, a comparative example 1 group, a comparative example 2 group, and a comparative example 3 group were set up. The blank group was given zebrafish embryo culture medium, and the other groups were given 100 μg / mL vinorelbine solution. Each group had 3 replicate wells, and the dosage in each well was 3.0 mL. The wells were placed in an incubator for reaction for 24 hours to construct a Qi deficiency model.

[0188] After the reaction, the blank group and the solvent group were replaced with corresponding solutions, and the other groups were washed three times with zebrafish embryo culture medium, replaced with corresponding drugs, and continued to be placed in the incubator for drug intervention for 12 hours.

[0189] (4) Neutrophil fluorescence intensity detection

[0190] After the drug intervention, the cells were washed three times with zebrafish embryo culture medium to remove the drugs.

[0191] The zebrafish were sucked into the anesthetic and allowed to stand for 3-5 min. The fry were sucked out and placed on a biconcave glass slide in an upright position under a fluorescence microscope to collect images of the whole fish.

[0192] Image J image processing software was used to count the neutrophils in the area from the end of the yolk sac to the tail.

[0193] (5) Model construction results

[0194] The blank group and solvent group, blank group and model group, model group and positive control group were compared pairwise. The statistical results of the two-sample T test showed that the fluorescence intensity of neutrophils in the counting interval of zebrafish in the blank group had no significant difference with that in the solvent group (p>0.05), and was higher than that in the model group (p<0.0001). The fluorescence intensity of neutrophils in the counting interval of zebrafish after 12 hours of positive drug treatment was significantly higher than that in the model group (p<0.0001 for Buzhong Yiqi Pills and p<0.01 for Korean Ginseng Yuan Drink). Figure 6 and Figure 7 In summary, 0.1% DMSO culture medium has no effect on zebrafish, indicating that the solvent has no effect on the entire experiment; zebrafish embryos will not be deformed or die after being treated with 0.1% DMSO-vinorelbine, and the zebrafish Qi deficiency model was successfully established.

[0195] (6) The Qi-tonifying effect of Yiqi Qingxin Granules

[0196] After the intervention of Yiqi Qingxin Granules, the fluorescence intensity of zebrafish neutrophils increased significantly compared with the model group (P<0.0001). See the staining diagram for details. Figure 7 , indicating that Yiqi Qingxin Granules has a significant effect on replenishing qi; compared with positive drugs, the effect of enhancing the fluorescence intensity of zebrafish neutrophils was significantly better than Buzhong Yiqi Pills (P<0.01) and Korean ginseng beverage (P<0.0001), indicating that Yiqi Qingxin Granules has a product advantage in replenishing qi.

[0197] On the basis of determining that the Yiqi Qingxin Granules are effective, further, 3 groups of preparation examples and 3 groups of control examples were set. It can be seen from Table 8 that compared with the model group, the fluorescence intensity of zebrafish neutrophils was significantly increased (P<0.0001). During the test period, the fluorescence intensity of neutrophils in the preparation examples 1-3 groups increased significantly, indicating that the Chinese medicine composition of the present invention has a very significant improvement effect on qi deficiency. Changing the proportion of each medicinal flavor in the Chinese medicine composition of the present invention (for example, reducing the dosage of the main medicine, see control example 1 group), replacing the medicinal flavor in the composition of the present invention with other medicinal flavors with similar efficacy (control example 2 group), changing the preparation method of the composition of the present invention (control example 3 group) or changing the composition of the present invention will lead to different degrees of reduction in the effect of the composition of the present invention on improving qi deficiency, which shows that the type of each medicinal flavor in the composition of the present invention, the dosage ratio and the preparation method all affect its qi-tonifying effect.

[0198] Table 8 Qi-tonifying effect of Yiqi Qingxin granules

[0199]

[0200] Example 5: Characterization of the blood-tonifying efficacy of Yiqi Qingxin Granules

[0201] (1) Solution preparation

[0202] 0.01 μg / mL phenylhydrazine solution: Take an appropriate amount of phenylhydrazine and dilute it to 0.01 μg / mL with zebrafish embryo culture medium.

[0203] o-Dianisidine dye: Accurately weigh 178.65 mg of o-dianisidine and 85.05 mg of sodium acetate, place in a 50 mL volumetric flask, add 2.5 mL of 30% hydrogen peroxide solution, and then make up to volume with 50% ethanol. Shake well, store in dark place, and use immediately after preparation.

[0204] Positive control drug culture medium: Select ferrous succinate tablets as the positive control drug, refer to the preparation method of Yiqi Qingxin Granule solution, and prepare 10 mg / mL mother solution for standby use. During the experiment, dilute with zebrafish embryo culture medium to the grouping concentration and preheat to about 28.5°C.

[0205] The preparation method of zebrafish embryo culture medium and Yiqi Qingxin granule solution is the same as that in Example 2.

[0206] (2) Zebrafish embryo culture

[0207] The zebrafish embryo culture method is the same as in Example 2.

[0208] (3) Anemia model construction and drug intervention

[0209] Normally developed zebrafish embryos at 2 to 3 dpf after fertilization were selected and randomly transferred into 12-well plates, with 10 to 15 zebrafish in each well.

[0210] Efficacy verification: A blank group, a model group, a Yiqi Qingxin granule group, and a positive control drug group (ferrous succinate tablets) were set up. The blank group was given zebrafish embryo culture medium, and the other groups were given 0.01 μg / mL phenylhydrazine solution. Each group had 5 replicate wells, and the dosage in each well was 3.0 mL. The wells were placed in an incubator for 12 hours to construct an anemia model.

[0211] Efficacy comparison: a blank group, a model group, a preparation example 1 group, a preparation example 2 group, a preparation example 3 group, a comparative example 1 group, a comparative example 2 group, and a comparative example 3 group were set up. The blank group was given zebrafish embryo culture medium, and the other groups were given 100 μg / mL vinorelbine solution. Each group had 3 replicate wells, and the dosage in each well was 3.0 mL. The wells were placed in an incubator for reaction for 24 hours to construct a Qi deficiency model.

[0212] After the reaction, the blank group was replaced with the corresponding solution, and the other groups were washed three times with zebrafish embryo culture medium, then replaced with the corresponding drugs and placed in the incubator for drug intervention for another 24 h.

[0213] (4) Heart red blood cell area detection

[0214] After the drug intervention, the cells were washed three times with zebrafish embryo culture medium to remove the drugs.

[0215] After staining with o-dianisidine for 15 min in the dark, the fish were washed three times with DMSO to remove the stain, placed on a biconcave glass slide in the anterolateral position, and placed under a fluorescence microscope to collect whole-fish images.

[0216] Image J image processing software was used to process the cardiac erythrocyte staining area.

[0217] (5) Model construction results

[0218] The blank group and model group, and the model group and positive control group were compared pairwise. The statistical results of the two-sample T test showed that compared with the blank group, the area of ​​zebrafish heart red blood cells in the model group was significantly reduced (P<0.0001); the area of ​​zebrafish heart red blood cells after 24 hours of positive drug treatment was significantly higher than that in the model group (P<0.0001). Figure 8 and Fig. 9 In summary, zebrafish embryos treated with 0.01 μg / mL phenylhydrazine did not show deformity or death, and the zebrafish anemia model was successfully established.

[0219] (6) The blood-tonifying effect of Yiqi Qingxin Granules

[0220] After the intervention of Yiqi Qingxin Granule, the area of ​​red blood cells in zebrafish heart increased significantly compared with the model group (P<0.0001). See the staining diagram for details. Fig. 9 , indicating that the blood-replenishing effect of Yiqi Qingxin Granules is obvious; compared with the positive drugs, there is no statistical difference in the red blood cell area of ​​zebrafish heart, indicating that the blood-replenishing effect of Yiqi Qingxin Granules is equivalent to that of the marketed drug ferrous succinate tablets.

[0221] On the basis of determining that the Yiqi Qingxin Granule is effective, further, 3 groups of Preparation Examples and 3 groups of Control Examples were set up. It can be seen from Table 9 that compared with the model group, the zebrafish zebrafish heart red blood cell area is larger (P<0.0001). During the test period, the zebrafish heart red blood cell area of ​​Preparation Examples 1-3 groups tended to be normal, indicating that the composition of the present invention has a very significant improvement effect on blood deficiency. Changing the ratio of each medicinal flavor in the composition of the present invention (for example, reducing the dosage of the main medicine, see Control Example 1 Group), replacing the medicinal flavor in the composition of the present invention with other medicinal flavors with similar efficacy (Control Example 2 Group), changing the preparation method of the composition of the present invention (Control Example 3 Group) or changing the composition of the present invention will lead to different degrees of reduction in the effect of the composition of the present invention on improving blood deficiency, which shows that the type of each medicinal flavor in the composition of the present invention, the dosage ratio and the preparation method all affect its qi-invigorating effect.

[0222] Table 9 Effect of Yiqiqingxin Granules on blood supplementation

[0223]

[0224] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include these modifications and variations.

Claims

1. A Qi-invigorating and blood-tonifying medicinal and edible composition, characterized in that: The invention is prepared from the following raw materials in parts by weight: 50-60 parts of yam, 20-40 parts of jujube, 10-20 parts of donkey-hide gelatin, 15-30 parts of malt, 5-20 parts of coix seeds, 5-20 parts of euryale seeds, 8-20 parts of tuckahoe, 4-12 parts of dried ginger, 8-20 parts of cinnamon bark, 2-10 parts of bergamot, 2-10 parts of citron, 2-10 parts of mint, 30-50 parts of liquorice, 8-20 parts of angelica dahurica, 8-20 parts of gardenia, 4-12 parts of dandelion, 5-15 parts of platycodon grandiflorum and 5-15 parts of fried bitter almonds.

2. The composition according to claim 1, characterized in that The invention is prepared from the following raw materials in parts by weight: 52-58 parts of yam, 25-35 parts of jujube, 12-17 parts of donkey-hide gelatin, 18-23 parts of malt, 8-13 parts of coix seeds, 8-13 parts of euryale seeds, 10-16 parts of poria, 4-8 parts of dried ginger, 10-16 parts of cinnamon, 2-10 parts of bergamot, 2-10 parts of citron, 2-10 parts of mint, 37-45 parts of liquorice, 8-14 parts of angelica dahurica, 8-14 parts of gardenia, 3-8 parts of dandelion, 6-12 parts of platycodon and 6-12 parts of fried bitter almonds.

3. The Chinese medicine composition according to claim 2, characterized in that: The invention is prepared from the following raw materials in parts by weight: 56 parts of yam, 30 parts of jujube, 14 parts of donkey-hide gelatin, 20 parts of malt, 10 parts of coix seeds, 10 parts of Euryale ferox, 12 parts of Poria, 6 parts of dried ginger, 14 parts of cinnamon, 4 parts of bergamot, 4 parts of citron, 4 parts of mint, 40 parts of licorice, 12 parts of angelica dahurica, 12 parts of gardenia, 6 parts of dandelion, 9 parts of platycodon, and 9 parts of fried bitter almonds.

4. The method for preparing the composition according to any one of claims 1 to 3, characterized in that: The following steps are involved: Step 1: Extraction: Take yam, jujube, donkey-hide gelatin, malt, coix seed, Euryale ferox, Poria, dried ginger, cinnamon, bergamot, citron, mint, licorice, angelica dahurica, gardenia, dandelion, platycodon, and fried bitter almonds, add 6 to 10 times the amount of water to the 18 medicinal materials, soak at room temperature for 10 to 60 minutes, heat to boiling, extract 2 to 3 times, the extraction time is 0.5 to 2 hours, filter, and combine to obtain an extract; Step 2: Concentration: The extract prepared in step 1 is concentrated at normal pressure to a relative density of 1.00-1.25 at 20°C to obtain an extract; Step 3: Drying: The extract prepared in step 2 is dried under reduced pressure, with a vacuum degree of 0.08-0.095 MPa, a temperature of 50-80°C, and a drying time of 20-30 h, until the moisture content is less than 5%, and then crushed and passed through a 200-mesh sieve to obtain a dry extract powder; Step 4: Granulation: add appropriate amount of excipients and wetting agents, wet granulate, dry at 50-60℃ for 1 h, and granulate to obtain; The excipient is selected from soluble starch or dextrin, and the wetting agent is 70-90% ethanol.

5. A medicinal and edible composition preparation for replenishing qi and blood, characterized in that: The preparation is prepared by the composition of any one of claims 1 to 3 or the composition prepared by the preparation method of claim 4 alone, or by mixing the composition of any one of claims 1 to 3 or the composition prepared by the preparation method of claim 4 with a pharmaceutically acceptable carrier.

6. Use of the composition according to any one of claims 1 to 3, or the composition prepared by the preparation method according to claim 4, or the composition preparation according to claim 5 in preparing products for improving qi deficiency and blood deficiency.

7. The use according to claim 6, characterized in that The product is used to improve low immunity.

8. The use according to claim 6, characterized in that The product is a pharmaceutical product.

9. The use according to claim 6, characterized in that: The dosage form of the product is selected from pills, powders, pastes, pills, granules, tablets, oral liquids or capsules.

10. The use according to claim 6, characterized in that The dosage form of the product is granules.

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