CN115245554A

CN115245554A - Poria cocos medicinal composition with stomach invigorating and spleen eliminating effects and application thereof

Info

Publication number: CN115245554A
Application number: CN202110461472.7A
Authority: CN
Inventors: 戴甲木; 侯凤飞; 戴鑫汶; 聂蔚; 邹奇; 唐心文; 张豪
Original assignee: Hunan Busky Pharmaceutical Co ltd
Current assignee: Hunan Busky Pharmaceutical Co ltd
Priority date: 2021-04-27
Filing date: 2021-04-27
Publication date: 2022-10-28

Abstract

The invention relates to a poria cocos medicinal composition with stomach and spleen invigorating effects, which comprises the following raw materials in parts by weight: 4-8 parts of poria cocos, 2-5 parts of Chinese yam, 2-5 parts of white hyacinth bean, 2-4 parts of coix seed, 1-3 parts of Chinese date, 1-3 parts of gordon euryale seed, 1-3 parts of fructus amomi, 1-3 parts of dried ginger, 1-4 parts of phaseolus calcaratus, 1-5 parts of orange peel, 1-3 parts of hawthorn, 1-2 parts of malt, 1-4 parts of wrinkled gianthyssop herb, 1-3 parts of elsholtzia, 1-3 parts of heartleaf houttuynia herb, 1-3 parts of dandelion, 1-3 parts of mint, 1-3 parts of purslane, 1-3 parts of chicory, 1-3 parts of perilla leaf and 1-3 parts of cape jasmine. The composition provided by the invention can regulate a human body to a certain degree from all angles of heart, liver, lung, spleen and kidney, and has obvious effects on invigorating spleen, promoting diuresis, invigorating stomach and promoting digestion.

Description

Poria cocos medicinal composition with stomach invigorating and spleen eliminating effects and application thereof

Technical Field

The invention relates to the field of biological medicine, and particularly relates to a poria cocos medicinal composition with stomach invigorating and spleen dispersing effects, and application, a preparation method and application thereof.

Background

The main functions of the stomach are two-fold: firstly, food is digested, and the food ingested by a human body needs to enter the stomach through the esophagus, then is digested through the stomach and then is transferred into the small intestine; secondly, nutrients are transmitted, nutrients in food are extracted from the digested food by the stomach and are transmitted to each part of the body through blood, if the stomach can well complete the work of absorbing the nutrients, the nutrient can be transmitted to other organs in the body on time, the appetite can be increased, the spirit is stimulated, otherwise, if the digestive function of the stomach is reduced, the appetite is influenced, and the phenomenon of halitosis can occur, the phenomena of weakness of the spleen and the stomach and dyspepsia are mostly manifested as discomfort of the upper abdomen or pain, fullness, heartburn, regurgitation and the like, the food is often taken or the food intake is very small because of discomfort such as chest distress, fullness, abdominal distension and the like, the existing digestion-assisting medicines mostly treat the symptoms and do not treat the root causes, the human body cannot be well regulated, and different degrees have toxic and side effects, the microenvironment of the body is easily unbalanced after long-term use, and the body health is influenced.

Poria is fungus belonging to Poria of Polyporales, has effects of promoting diuresis, eliminating dampness, invigorating spleen, calming heart and tranquilizing mind, and can be used for preventing and treating edema, oliguria, phlegm and fluid retention, dizziness and palpitation, spleen deficiency, anorexia, loose stool, diarrhea, uneasiness, palpitation, insomnia, etc. The carboxymethyl pachyman extracted and prepared from tuckahoe has excellent pharmacological action: 1) Depends on the immune system of a host, enhances the immunity (specificity and non-specificity) of the organism, inhibits and kills tumor cells. By activating complement, various lymphocyte active factors are induced, the activity of macrophages, NK cells, T lymphocytes and B lymphocytes is enhanced, and the anti-tumor and anti-virus effects are exerted through multi-way synergy; 2) Inhibit the synthesis of DNA and RNA of tumor cells, and directly kill and kill the tumor cells; 3) Increasing Sialic Acid (SA) content on tumor cell membrane, inhibiting PI conversion, and reducing arachidonic acid (C) ₂₀ ) The multi-way inhibition of division and proliferation of tumor cells;

4) Enhancing liver SOD activity, scavenging oxygen free radicals, decomposing carcinogen, and preventing DNA variation of normal cells.

Chinese yam is a good product for entering lung, strengthening spleen and tonifying kidney. The Chinese yam contains amylase, polyphenol oxidase and other substances, is beneficial to the digestion and absorption functions of the spleen and the stomach, and is a medicine and food dual-purpose product for tonifying the spleen and the stomach. It is indicated for deficiency of spleen yang or stomach yin. Clinically, it is commonly used to treat weakness of spleen and stomach, anorexia, tiredness, diarrhea, etc. The rhizoma Dioscoreae contains multiple nutrients, and has effects of strengthening body constitution, replenishing kidney essence and replenishing vital essence. It is indicated for seminal emission due to kidney deficiency, leukorrhagia, frequent urination, etc. The yam contains saponin and mucus, has the functions of lubrication and moistening, and can tonify lung qi, nourish lung yin and treat chronic cough due to lung deficiency and phlegm.

The white hyacinth bean has the main functions of strengthening the spleen, promoting diuresis and stopping diarrhea, can strengthen the spleen and stomach and clear away summer-heat and dampness, and has good effect on patients with weakness of the spleen and stomach, diarrhea due to summer-heat and dampness and leukorrhagia.

The raw coix seeds are cold and cool, promote diuresis and drain dampness, can remove dampness and wind, clear heat and discharge pus, remove arthralgia and relieve pain, and have obvious effects on dysuria, edema, beriberi, rheumatic pain and the like.

The red bean has the effects of promoting blood circulation, enriching blood, strengthening spleen, removing dampness, inducing diuresis and relieving swelling when being used as a medicine. The actions of inducing diuresis for treating stranguria, removing dampness and removing jaundice have long application history and many prescriptions, such as Zhong Chi Xiao Dou Tang from Sheng Ji Zong Lu, zhong Huang Lian Qiao Chi Xiao Dou Tang from Shang Han Lun, zhong Chi Xiao Dou san from Sheng Hui Fang, etc. Modern researches find that the traditional Chinese medicine composition has good effect of treating diseases such as acute nephritis, ascites due to cirrhosis, chicken pox, parotitis, inflammatory external hemorrhoids, skin diseases and the like, and also has multiple effects such as oxidation resistance, estrogen-like effect and the like.

Disclosure of Invention

The invention aims to provide a poria cocos medicinal composition with stomach and spleen invigorating effects, which comprises the following raw materials in parts by weight: 4-8 parts of poria cocos, 2-5 parts of Chinese yam, 2-5 parts of white hyacinth bean, 2-4 parts of coix seed, 1-3 parts of Chinese date, 1-3 parts of gordon euryale seed, 1-3 parts of fructus amomi, 1-3 parts of dried ginger, 1-4 parts of phaseolus calcaratus, 1-5 parts of orange peel, 1-3 parts of hawthorn, 1-2 parts of malt, 1-4 parts of wrinkled gianthyssop herb, 1-3 parts of elsholtzia, 1-3 parts of heartleaf houttuynia herb, 1-3 parts of dandelion, 1-3 parts of mint, 1-3 parts of purslane, 1-3 parts of chicory, 1-3 parts of perilla leaf and 1-3 parts of cape jasmine.

In the preferable technical scheme of the invention, the content of the tuckahoe in the composition is 1 to 2.5 parts, and preferably 1.5 to 2 parts.

In a preferred technical scheme of the invention, the poria cocos in the composition is any one of poria cocos coarse powder, pachymaran alkalization extract, pachymaran and high-substitution-degree carboxymethyl pachymaran (CMP).

In the preferred technical scheme of the invention, the preparation method of the high-substitution-degree carboxymethyl pachyman comprises the following steps: 1) Adding pachymaran into water or water-alcohol mixed solution, stirring, adding alkaline solution with a mass of 1-8% of pachymaran, and stirring to completely dissolve to obtain pachymaran alkalized solution; 2) And (2) after fully reacting 1.0-10mol/L chloroacetic acid with proper excess 2.0-10mol/L alkaline solution, adding the obtained product into the pachyman alkalization solution obtained in the step 1), and performing substitution reaction, separation and purification to obtain the pachyman alkalization solution, wherein the proper excess is that the actual dosage of alkaline substances in the alkaline solution is 0.5-40% more than the theoretical dosage required by the neutralization reaction between the alkaline substances and chloroacetic acid.

In a preferable technical scheme of the invention, the pachyman obtained in step 1) is selected from pachyman alkaline extract obtained by an alkaline extraction method or pachyman crude product obtained by an alkaline extraction and acid precipitation method.

In the preferred technical scheme of the invention, the preparation method of the pachyman alkalization extracting solution comprises the following steps of adding the tuckahoe powder into an alkaline solution with the concentration of 1.0-4.0mol/L for alkalization extraction, carrying out centrifugal separation, and taking the supernatant to obtain the pachyman alkalization extracting solution.

In the preferred technical scheme of the invention, the preparation method of the pachymaran comprises the following steps of stirring and extracting tuckahoe powder by using an alkaline solution with the concentration of 1.0-4.0mol/L, performing centrifugal separation, and taking supernatant; adding acid into the supernatant, centrifuging the obtained acid precipitate, and washing with water to obtain pachyman, wherein the acid is selected from one of acetic acid, hydrochloric acid, sulfuric acid, and nitric acid.

In the preferable technical scheme of the invention, the concentration of the alkaline solution is 2.0-3.0mol/L.

In a preferred technical scheme of the invention, the water-alcohol mixed solution is a solution prepared by adding water into an alcohol solvent, wherein the alcohol solvent is any one or a combination of methanol, ethanol, propylene glycol, ethyl acetate, acetone, dimethyl sulfoxide, diethyl ether, isopropanol and dimethylformamide.

In the preferable technical scheme of the invention, the alkaline solution added in the step 1) is 2-6% of the weight of the pachymaran, and the alkaline solution added in the step 1) is preferably 3-5% of the weight of the pachymaran.

In a preferred technical scheme of the invention, the alkaline solution is prepared by dissolving an alkaline substance in water, wherein the alkaline substance is any one or combination of sodium hydroxide, potassium hydroxide, sodium carbonate and potassium carbonate.

In a preferred embodiment of the present invention, the alkaline substance is selected from any one of sodium hydroxide or potassium hydroxide, or a combination thereof.

In a preferred technical scheme of the invention, the concentration of the chloroacetic acid solution is 2.0-9.0mol/L, preferably 3.0-8.0mol/L, more preferably 4.0-7.0mol/L, and further preferably 4.5-6.0mol/L.

In a preferable technical scheme of the invention, the concentration of the alkaline solution in the step 2) is 3.0-9.0mol/L, preferably 4.0-8.0mol/L, more preferably 5.0-7.0mol/L, and still more preferably 5.5-6.5mol/L.

In a preferred embodiment of the present invention, the proper excess is 5-30%, preferably 10-25%, and more preferably 15-20% of the actual amount of the basic substance in the basic solution, which is larger than the theoretical amount of the basic substance required for the neutralization reaction with chloroacetic acid.

In the preferable technical scheme of the invention, the reaction solution in the step 2) is subjected to substitution reaction for 1-5h at the temperature of 30-100 ℃.

In the preferable technical scheme of the invention, the reaction time in the step 2) is 2-4h, preferably 2.5-3.5h.

In the preferable technical scheme of the invention, the reaction temperature in the step 2) is 40-90 ℃, preferably 50-85 ℃, more preferably 60-82 ℃ and further preferably 75-80 ℃.

In a preferred technical scheme of the invention, the separation comprises the following steps of adding 1.0-10mol/L acid solution into the reaction product liquid obtained in the step 2), adjusting the pH value to 5.0-7.0, adding 3-5 times of volume of alcohol solvent to precipitate a CMP crude product, wherein the alcohol solvent is selected from any one or combination of methanol, ethanol, propylene glycol, ethyl acetate, isopropanol, diethyl ether and acetone.

In a preferred technical scheme of the invention, the acidic solution is prepared by dissolving an acidic substance in water, wherein the acidic substance is selected from any one or combination of acetic acid, hydrochloric acid, sulfuric acid and nitric acid.

In the preferred technical scheme of the invention, the purification comprises the following steps of adding water into CMP to be purified to prepare 1.0-6.0% aqueous solution, and adding 1.0-10mol/L alkaline solutionAdjusting pH to 9.0-12.0, and stirring until CMP is completely dissolved; adding 30% of H ₂ O ₂ The dosage of the solution is 0.1 per mill to 2.0 per mill of the total volume of the solution, and the decolorization reaction is carried out; adding 1.0-10mol/L acid solution to adjust pH to 5.0-7.0, ultrafiltering to remove molecular weight less than 0.7 × 10 ⁴ Dalton CMP and other small molecule impurities.

In a preferred embodiment of the invention, the concentration of the aqueous CMP solution to be purified is from 2.0 to 5.0%, preferably from 3 to 4%.

In a preferred embodiment of the present invention, the concentration of the alkaline solution used in the purification step is 2.0 to 9.0mol/L, preferably 3.0 to 8.0mol/L, more preferably 4.0 to 7.0mol/L, and still more preferably 5.0 to 6.0mol/L.

In a preferred embodiment of the present invention, the content of 30% by weight ₂ O ₂ The dosage of the solution is 0.5-1.0 ‰ of the total volume of the solution.

In the preferred technical scheme of the invention, the decolorizing reaction temperature is 10-70 ℃, preferably 15-60 ℃, and more preferably 20-50 ℃.

In a preferred technical scheme of the invention, the time of the decolorization reaction is 2-48h, preferably 5-40h, more preferably 10-30h, and still more preferably 15-25h.

In a preferred embodiment of the present invention, the concentration of the acidic solution is 1.0-9.0mol/L, preferably 2.0-8.0mol/L, more preferably 3.0-7.0mol/L, and preferably 4.0-6.0mol/L.

In the preferred technical scheme of the invention, the ultrafiltration medium is a DH-UF hollow fiber ultrafilter.

In a preferred technical scheme of the invention, the separation and purification is repeated separation and purification.

In a preferred embodiment of the present invention, the CMP substitution degree is not less than 1.05, preferably not less than 1.10, and more preferably not less than 1.2.

In a preferred embodiment of the present invention, the molecular weight of the CMP is 0.7X 10 ⁴ -1.0×10 ⁶ Dalton, preferably 3.0X 10 ⁴ -8×10 ⁵ Dalton, more preferably 6.0X 10 ⁴ -5.0×10 ⁵ Dalton, preferably also 8.0X 10 ⁴ -3.0×10 ⁵ And D, dalton.

In a preferred embodiment of the present invention, the CMP degree of polymerization is 32-yarn n-yarn 4545, preferably 136-yarn n-yarn 3636, more preferably 272-yarn n-yarn 2272, and still more preferably 363-yarn n-yarn 1363.

In a preferred embodiment of the present invention, the composition further comprises a pharmaceutically acceptable carrier in a desired amount.

In a preferred embodiment of the present invention, the pharmaceutically acceptable carrier is selected from any one of or a combination of fillers (also called diluents), lubricants (also called glidants or antiadherents), dispersants, wetting agents, binders, regulators, solubilizers (also called stabilizers), antioxidants, emulsifiers, flavors, and flavoring agents.

In a preferred technical scheme of the invention, the binding agent is selected from any one or combination of syrup, arabic gum, gelatin, sorbitol, tragacanth, cellulose, microcrystalline cellulose, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose, gelatin slurry, syrup, starch, sodium carboxymethyl starch, sodium starch glycolate, pregelatinized starch, modified starch, hydroxypropyl starch, corn starch, starch slurry and polyvinylpyrrolidone.

In a preferred technical scheme of the invention, the filler is selected from any one of lactose, powdered sugar, dextrin, starch or derivatives thereof, cellulose, microcrystalline cellulose, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl methyl cellulose, calcium sulfate, calcium phosphate, calcium hydrogen phosphate, precipitated calcium carbonate, sorbitol, glycine, sodium carboxymethyl starch, sodium starch glycolate, pregelatinized starch, modified starch, hydroxypropyl starch and corn starch or a combination thereof.

In a preferred technical scheme of the invention, the lubricant is selected from any one of or a combination of superfine silica powder, magnesium stearate, talcum powder, aluminum hydroxide, boric acid, hydrogenated vegetable oil and polyethylene glycol.

In a preferred technical scheme of the invention, the disintegrating agent is selected from any one of starch, sodium carboxymethyl starch, sodium starch glycolate, pregelatinized starch, modified starch, hydroxypropyl starch, corn starch, polyvinylpyrrolidone, cross-linked polyvinylpyrrolidone and microcrystalline cellulose or a combination thereof.

In a preferred embodiment of the present invention, the wetting agent is selected from any one of sodium lauryl sulfate, water, alcohol, or a combination thereof.

In a preferred technical scheme of the invention, the emulsifier is selected from any one of polysorbate-80, sorbitan fatty acid, pluronic F-68, lecithin and soybean lecithin or a combination thereof.

In a preferred embodiment of the present invention, the acid-base regulator is selected from any one of inorganic acids and organic acids or a combination thereof, preferably selected from any one of citric acid, sodium citrate, malic acid, sodium malate, hydrochloric acid, acetic acid, sodium acetate, phosphoric acid, sodium hydrogen phosphate, sodium dihydrogen phosphate, carbonic acid, sodium carbonate, sulfonic acid, sodium sulfonate, glutamic acid, tartaric acid, sodium tartrate, lactic acid, sodium lactate, fumaric acid, sodium fumarate, itaconic acid, ascorbic acid, sodium ascorbate, nicotinic acid, sodium nicotinate, fumaric acid, α -ketoglutaric acid, tartaric acid, sodium malate, acetic acid, oxalic acid, succinic acid, carbon dioxide, citric acid, and sodium citrate, or a combination thereof.

In the preferable technical scheme of the invention, the concentration of the pH regulator is 0.5-8mol/L, preferably 0.8-6mol/L, more preferably 1-5mol/L, and further preferably 2-4mol/L.

In a preferred embodiment of the present invention, the stabilizer (solubilizer) is selected from any one of glycerol, tween-80, or a combination thereof.

In a preferred technical scheme of the invention, the antioxidant is selected from any one of potassium sorbate, sodium sulfite, sodium bisulfite, sodium metabisulfite and dibutylbenzoic acid or a combination thereof.

In a preferred embodiment of the present invention, the flavoring agent is selected from any one of or a combination of flavors, fragrances, and flavoring essences.

The compositions of the present invention may be in a variety of dosage forms well known in the art and may be prepared using formulation techniques conventional in the art.

In a preferred technical scheme of the invention, the composition is an oral preparation.

In a preferred technical scheme of the invention, the oral preparation is selected from any one of oral liquid (liquid preparation), syrup, suspension, tablets, capsules, granules, pills, powder, dripping pills, mixture, distillate, effervescent, paste, emulsion and tea.

In the preferred technical scheme of the invention, the active ingredients and pharmaceutically acceptable sustained-release carriers can be mixed according to the preparation requirements, and then the mixture is prepared into sustained-release pellets or controlled-release pellets according to the preparation method of the sustained-release preparation well known in the field, such as adding retardant coating or microencapsulating the active ingredients; the sustained and controlled release carrier comprises but is not limited to an oil-fat doping agent, a hydrophilic colloid, a coating retarder and the like, wherein the oil-fat doping agent is selected from any one or the combination of glyceryl monostearate, hydrogenated castor oil, mineral oil, polysiloxane and dimethyl siloxane; the hydrophilic colloid is selected from any one or combination of sodium carboxymethylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, PVP, acacia, tragacanth and carbopol; the coating retarder is selected from any one of Ethyl Cellulose (EC), hydroxypropyl methyl cellulose (HMPC), polyvinylpyrrolidone (PVP), cellulose Acetate Phthalate (CAP) and acrylic resin or the combination thereof.

In the preferred technical scheme of the invention, the composition comprises the following raw materials in parts by weight: 4 parts of poria cocos, 2 parts of Chinese yam, 2 parts of white hyacinth beans, 2 parts of coix seeds, 1 part of Chinese dates, 1 part of gordon euryale seeds, 1 part of fructus amomi, 1 part of dried ginger, 2 parts of phaseolus calcaratus, 2 parts of orange peels, 1 part of hawthorn fruits, 1 part of malt, 2 parts of agastache rugosus, 1 part of elsholtzia, 1 part of houttuynia cordata, 1 part of dandelion, 1 part of mint, 1 part of purslane, 1 part of chicory, 1 part of perilla leaves and 1 part of cape jasmine fruits.

The invention also aims to provide a preparation method of the poria cocos medicinal composition with the effects of invigorating stomach and eliminating spleen, wherein the composition comprises the following raw materials in parts by weight: 4-8 parts of poria cocos, 2-5 parts of Chinese yam, 2-5 parts of white hyacinth bean, 2-4 parts of coix seed, 1-3 parts of Chinese date, 1-3 parts of gordon euryale seed, 1-3 parts of fructus amomi, 1-3 parts of dried ginger, 1-4 parts of phaseolus calcaratus, 1-5 parts of orange peel, 1-3 parts of hawthorn, 1-2 parts of malt, 1-4 parts of wrinkled gianthyssop herb, 1-3 parts of elsholtzia, 1-3 parts of heartleaf houttuynia herb, 1-3 parts of dandelion, 1-3 parts of mint, 1-3 parts of purslane, 1-3 parts of chicory, 1-3 parts of perilla leaf and 1-3 parts of gardenia, and the specific preparation method comprises the following steps: all the raw materials are uniformly mixed and then crushed to 60 to 140 meshes, and the mixture is sterilized to obtain the feed additive.

The invention also aims to provide application of the poria cocos medicinal composition with stomach invigorating and spleen invigorating effects in preparation of a product for improving gastrointestinal functions.

In a preferable technical scheme of the invention, the gastrointestinal function improvement is any one selected from immunity enhancement, antivirus, liver protection, antibiosis, diuresis, fatigue resistance, constipation prevention, gastrointestinal inflammation prevention and dyspepsia prevention.

In a preferred embodiment of the present invention, the dosage of the composition is related to the age, sex, health status, current treatment status, concomitant medication and the like of the patient, and the recommended dosage is 5-10 g/time and 2-3 times/day.

Unless otherwise indicated, when the present invention relates to percentages between liquids, said percentages are volume/volume percentages; when the invention relates to percentages between liquid and solid, said percentages are volume/weight percentages; the invention relates to the percentages between solid and liquid, said percentages being weight/volume percentages; the balance being weight/weight percent.

Compared with the prior art, the invention has the following beneficial technical effects:

(1) The composition of the invention scientifically screens the components and the proportion of the raw materials, the poria cocos is taken as a main material, the poria cocos has certain efficacy in invigorating spleen and removing dampness by diuresis, but the effect is not ideal when the poria cocos acts alone or only a plurality of the raw materials are combined for use, the human body operation mechanism is complex, the invention continuously adjusts the test formula and finds that after the auxiliary materials of Chinese yam, white hyacinth bean, coix seed and red bean are added, and the auxiliary materials of amomum fruit, dried ginger, orange peel, hawthorn, malt, agastache rugosus, elsholtzia, houttuynia cordata, dandelion, mint, purslane, chicory, perilla leaf and gardenia are added, the raw material components are compounded to generate the synergistic effect, and the raw material components cooperate to regulate the human body to a certain degree from all angles of heart, liver, lung, spleen and kidney, and have obvious effects on invigorating spleen, promoting digestion and strengthening stomach.

Tuckahoe, sweet and light in flavor, neutral in nature, enters heart, lung, spleen and kidney channels, induces diuresis and excretes dampness, strengthens spleen and calms heart; the yam is sweet in nature, warm, mild, nontoxic, tonifying deficiency, removing cold and heat evil, tonifying middle-jiao, tonifying qi, tonifying spleen and stomach, promoting fluid production and benefiting lung, tonifying kidney and arresting seminal emission; white hyacinth bean, invigorating spleen to eliminate dampness, regulating stomach and relieving summer heat; the coix seeds have the effects of tonifying spleen and eliminating dampness, removing arthralgia and checking diarrhea, and clearing heat and expelling pus; the Chinese date has the effects of tonifying middle-jiao and Qi, nourishing blood and soothing nerves; semen euryales has effects of invigorating kidney, stopping nocturnal emission, invigorating spleen, relieving diarrhea, eliminating dampness, and stopping leukorrhagia; fructus amomi is pungent in taste and warm in nature, enters spleen, stomach and kidney channels, disperses according to fragrance, lowers middle energizer, dissolves dampness and stimulates appetite, warms spleen and stops diarrhea; dried ginger, rhizoma Zingiberis, warming the middle-jiao to dispel cold, restoring yang to activate collaterals, drying dampness and eliminating phlegm; the small red bean has the effects of inducing diuresis to alleviate edema, detoxifying and expelling pus; orange peel, fructus Citri Tangerinae, for dispelling cold and eliminating dampness, and promoting qi and eliminating phlegm; the hawthorn can promote digestion, invigorate the stomach, promote qi circulation and remove blood stasis; malt, promoting the circulation of qi to promote digestion, invigorating spleen to stimulate appetite, and relieving lactation and flatulence; agastache rugosus, pungent and slightly warm, has the functions of invigorating spleen, stomach and lung channels, eliminating dampness with aromatics, harmonizing stomach, preventing vomiting, removing dirt, regulating the middle warmer, dispelling summer heat, relieving exterior syndrome, and has good sterilization and anticorrosion effects; herba Moslae, inducing sweat to relieve exterior syndrome, regulating the middle warmer and promoting diuresis; the heartleaf houttuynia herb has the effects of clearing heat and removing toxicity, eliminating carbuncle and expelling pus, and inducing diuresis for treating stranguria, and has the effects of resisting bacteria and viruses, improving the immunity of the organism, inducing diuresis and the like; the dandelion enters liver and stomach channels, clears away heat and toxic materials, reduces swelling, eliminates stagnation, relieves food toxicity and dissipates stagnation of qi; the mint has the effects of dispelling wind heat, clearing head and eyes and promoting eruption, and contains menthol, so that the mint has the effects of preventing corrosion and sterilizing, promoting urination, reducing phlegm, invigorating stomach, aiding digestion and the like; purslane, which has the effects of clearing away heat and toxic materials, cooling blood and stopping bleeding; chicory has the effects of clearing liver and promoting bile flow, strengthening spleen to promote digestion, and inducing diuresis to reduce edema; perilla leaf, relieving exterior syndrome and dispelling cold, promoting qi circulation and regulating stomach; gardenia jasminoides ellis has the effects of purging fire, relieving restlessness, clearing heat, promoting urination, cooling blood and removing toxicity.

(2) The medicinal composition has the advantages of rich raw materials, easy production, fresh mouthfeel and fresh aroma, can play the effects of strengthening spleen and calming heart, helping digestion and invigorating stomach, promoting qi circulation and removing blood stasis after being taken for a period of time, has a good health-care effect on a human body, and has remarkable economic and social benefits.

(3) The pharmaceutical composition provided by the invention is fully considered from the aspects of efficacy, smell, taste and safety, and the raw material components and the formula of the pharmaceutical composition are obtained through long-term tests and verification.

(3) All the raw materials are medicinal and edible, and all the components and the collocation are carefully considered and tested without any toxic or side effect. The preparation method has the advantages of simple operation and obvious cost benefit, and is suitable for industrial mass production.

Detailed Description

The present invention is described below with reference to examples. The invention is not limited to the embodiments.

Example 1

The poria cocos composition provided by the embodiment comprises the following raw materials: the health-care food is prepared by uniformly mixing all raw materials, crushing into 60-140 meshes to obtain mixed powder, bagging the mixed powder, and sterilizing.

Example 2

The poria cocos health-care particles comprise the following raw materials: 4kg of poria cocos, 2kg of Chinese yam, 2kg of white hyacinth bean, 2kg of coix seed, 1kg of Chinese date, 1kg of gordon euryale seed, 1kg of fructus amomi, 1kg of dried ginger, 2kg of phaseolus calcaratus, 2kg of orange peel, 1kg of hawthorn, 1kg of malt, 2kg of wrinkled gianthyssop herb, 1kg of elsholtzia, 1kg of houttuynia cordata, 1kg of dandelion, 1kg of mint, 1kg of purslane, 1kg of chicory, 1kg of perilla leaf and 1kg of gardenia.

The preparation method comprises the following steps:

1) Soaking: adding water 8 times the weight of the Poria cocos composite material into the Poria cocos composite material, stirring and soaking the Poria cocos mixture for 60min;

2) Extraction: continuously adding water 8 times the weight of Poria cocos composite material, heating to boil, timing, keeping boiling for extraction for 60min, and filtering to obtain a first extractive solution; adding water 6 times the weight of Poria cocos compound material into the residue, heating to boil, timing, extracting for 50min, and filtering to obtain a second extractive solution; adding water 5 times the weight of Poria cocos compound material into the residue, heating to boil, timing, extracting for 40min under slight boiling, filtering to obtain a third extractive solution, mixing the first, second and third extractive solutions, and sieving with 300 mesh sieve to obtain a mixed extractive solution;

3) Concentrating and drying: heating and concentrating the mixed extracting solution until the mass of the mixed extracting solution is 1 time of that of the tuckahoe compound material to obtain concentrated solution, spray-drying the concentrated solution to obtain tuckahoe compound powder, and adding soluble starch or maltodextrin or a mixture of the soluble starch and the maltodextrin, which accounts for 8 parts by mass of the tuckahoe compound powder, into the spray-drying process;

4) Seasoning: uniformly mixing the tuckahoe composite powder with seasonings, wherein the seasonings comprise aspartame accounting for 1.03 percent of the weight of the tuckahoe composite powder, sodium cyclamate accounting for 1.03 percent of the weight of the tuckahoe composite powder and xylitol accounting for 15 percent of the weight of the tuckahoe composite powder, and the tuckahoe composite powder, the aspartame, the sodium cyclamate and the xylitol are uniformly mixed when the tuckahoe composite powder is added, and the seasonings can also be white granulated sugar or sucrose accounting for 200 percent of the weight of the tuckahoe composite powder;

5) Granulating: adding soluble starch or maltodextrin or a mixture of the soluble starch and the maltodextrin into the seasoned tuckahoe composite powder to ensure that the whole weight is 20 times of the weight of the tuckahoe composite powder, then adopting 60-80% ethanol solution to granulate in a wet mixing granulator to obtain tuckahoe health-care granules, sterilizing the tuckahoe health-care granules, and then bagging and packaging.

Example 3

The poria cocos health-care beverage comprises the following raw materials: 4kg of poria cocos, 2kg of Chinese yam, 2kg of white hyacinth bean, 2kg of coix seed, 1kg of Chinese date, 1kg of gordon euryale seed, 1kg of fructus amomi, 1kg of dried ginger, 2kg of phaseolus calcaratus, 2kg of orange peel, 1kg of hawthorn, 1kg of malt, 2kg of wrinkled gianthyssop herb, 1kg of elsholtzia, 1kg of houttuynia cordata, 1kg of dandelion, 1kg of mint, 1kg of purslane, 1kg of chicory, 1kg of perilla leaf and 1kg of gardenia.

The preparation method comprises the following steps:

2) Extraction: continuously adding water 8 times the weight of Poria cocos composite material, heating to boil, timing, keeping boiling for extraction for 60min, and filtering to obtain a first extractive solution; adding water 6 times the weight of Poria cocos compound material into the residue, heating to boil, timing, extracting for 50min, and filtering to obtain a second extractive solution; adding water 5 times the weight of Poria cocos composite material into the residue, heating to boil, timing, extracting for 40min under slight boiling, filtering to obtain a third extractive solution, mixing the first, second and third extractive solutions, and sieving with 300 mesh sieve to obtain a mixed extractive solution;

3) And (3) concentrating: heating and concentrating the mixed extracting solution until the mass of the mixed extracting solution is 0.8 times of that of the tuckahoe compound material to obtain concentrated solution;

4) Seasoning: mixing the concentrated solution with flavoring agent, sterilizing, and packaging, wherein the flavoring agent comprises aspartame 1.03 wt%, sodium cyclamate 1.03 wt%, and xylitol 12 wt%, and the concentrated solution is uniformly mixed with aspartame, sodium cyclamate, and xylitol when adding.

Example 4

The composition is prepared from the following components in parts by weight:

CMP 6kg, chinese yam 3kg, white hyacinth bean 3kg, coix seed 3kg, chinese date 1.5kg, gordon euryale seed 1.5kg, amomum fruit 1.5kg, dried ginger 1.5kg, red bean 3kg, orange peel 3kg, hawthorn 1.5kg, malt 1.5kg, wrinkled gianthyssop 3kg, chinese mosla herb 1.5kg, cordate houttuynia 1.5kg, dandelion 1.5kg, peppermint 1.5kg, purslane 1.5kg, chicory 1.5kg, perilla leaf 1.5kg and cape jasmine 1.5kg.

The preparation method of the composition comprises the following steps:

s1, roughly crushing 75kg of poria cocos into 10-200 meshes by using a traditional Chinese medicine crusher to obtain poria cocos coarse powder, and weighing the poria cocos coarse powder with required amount;

1) Putting Poria coarse powder into soaking tank, pumping 400L water, stirring, and soaking for 12 hr;

2) Slowly pumping 400L of sodium hydroxide solution with the concentration of 2.25mol/L into a soaking tank, stirring for reaction for 1 hour, and filtering to obtain filtrate;

3) Adding 300L of chloroacetic acid solution with the concentration of 5.3mol/L into a neutralization tank, slowly adding 300L of sodium hydroxide solution with the concentration of 6.25mol/L, stirring until the reaction is fully carried out, and cooling to room temperature;

4) Pumping the reaction solution obtained in the step 3) into the filtrate obtained in the step 2), fully and uniformly mixing, slowly heating to 75 ℃, and reacting for 2.5 hours at constant temperature;

5) Adjusting pH value of the reaction solution obtained in step 4) to 5.0-7.0 with 6mol/L hydrochloric acid solution, adding 95% ethanol with volume 3 times of that of the reaction solution, stirring uniformly, filtering, washing, and taking CMP alcohol precipitate;

6) Drying the CMP alcohol precipitate at 60 ℃ for 4h, and then drying at 105 ℃ for 2h to obtain 37.5kg of CMP crude product;

7) Dispersing 7.5kg of CMP crude product in 250L of double distilled water, and adding 6mol/L of sodium hydroxide solution to adjust the pH value to 10.0-13.0; 1.25L of 30% H are added ₂ O ₂ Carrying out a decoloring reaction on the solution at 15 ℃ for 36 hours to remove colored impurities; adding 6mol/L hydrochloric acid solution to adjust the pH value to 6.0, centrifuging at 3000 rpm for 30min, collecting filtrate, filtering the filtrate with DH-UF hollow fiber ultrafilter to remove CMP with molecular weight below 0.7 × 104 and trace amount of sodium chloride, sodium chloroacetate and sodium glycolate, adding 3 times of 95% ethanol, precipitating with ethanol, filtering or centrifuging, drying the precipitate at 60 deg.C for 4 hr, drying at 105 deg.C for 2 hr, and pulverizing to obtain 6.0kg of pure CMP product with carboxymethyl substitution of 1.0:

s2, crushing the pure CMP product, sieving the crushed pure CMP product by a 60-mesh sieve, adding other raw materials in required amount, uniformly mixing, crushing the mixture to 60-140 meshes to obtain mixed powder, and bagging and sterilizing the mixed powder.

Example 5

The composition is prepared from the following components in parts by weight:

6kg of CMP, 3kg of Chinese yam, 3kg of white hyacinth bean, 3kg of coix seed, 1.5kg of Chinese date, 1.5kg of gordon euryale seed, 1.5kg of fructus amomi, 1.5kg of dried ginger, 3kg of phaseolus calcaratus, 3kg of orange peel, 1.5kg of hawthorn, 1.5kg of malt, 3kg of wrinkled gianthyssop herb, 1.5kg of Chinese mosla herb, 1.5kg of cordate houttuynia, 1.5kg of dandelion, 1.5kg of mint, 1.5kg of purslane, 1.5kg of chicory, 1.5kg of perilla leaf and 1.5kg of gardenia.

The preparation method of the composition comprises the following steps:

6) Drying the CMP alcohol precipitate at 60 deg.C for 4 hr, and drying at 105 deg.C for 2 hr to obtain CMP crude product 37.5kg;

7) Dispersing 7.5kg of the CMP crude product in 250L of double distilled water, and adding 6mol/L of sodium hydroxide solution to adjust the pH value to 10.0-13.0; 1.25L of 30% H were added ₂ O ₂ Carrying out a decoloring reaction on the solution at 15 ℃ for 36 hours to remove colored impurities; adding 6mol/L hydrochloric acid solution to adjust pH to 6.0, centrifuging at 3000 r/min for 30min, collecting filtrate, filtering with DH-UF hollow fiber ultrafilter to remove the filtrate with molecular weight of 0.7 × 10 ⁴ Adding 95% ethanol 3 times the volume of the filtrate into the filtrate after the following CMP and trace impurities such as sodium chloride, sodium chloroacetate and sodium glycolate are added, carrying out alcohol precipitation, filtering or centrifuging, drying the CMP alcohol precipitate at 60 ℃ for 4h, drying at 105 ℃ for 2h, and crushing to obtain 6.0kg of pure CMP product with the carboxymethyl substitution degree of 1.0:

s2, crushing the pure CMP product, and sieving the crushed pure CMP product with a 60-mesh sieve.

S3, adding water accounting for 8 times of the mass of the poria cocos composite material into other raw materials in the required amount in CMP, stirring and soaking the poria cocos composite material for 60min;

s4, continuously adding water which accounts for 8 times of the mass of the poria cocos composite material, heating to boil, timing, keeping the boiling for extraction for 60min, and filtering to obtain a first extracting solution; continuously adding water with the mass 6 times of that of the poria cocos composite material into filter residues, heating to boil, timing, keeping the temperature for extracting for 50min, and filtering to obtain a second extracting solution; adding water 5 times the weight of Poria cocos compound material into the residue, heating to boil, timing, extracting for 40min under slight boiling, filtering to obtain a third extractive solution, mixing the first, second and third extractive solutions, and sieving with 300 mesh sieve to obtain a mixed extractive solution;

s5, heating and concentrating the mixed extracting solution until the mass of the mixed extracting solution is 0.8 time of that of the poria cocos composite material to obtain a concentrated solution;

and S6, mixing the concentrated solution with seasonings, sterilizing and subpackaging, wherein the seasonings comprise aspartame accounting for 1.03 percent of the mass of the concentrated solution, sodium cyclamate accounting for 1.03 percent of the mass of the concentrated solution and xylitol accounting for 12 percent of the mass of the concentrated solution, and the concentrated solution is uniformly mixed with the aspartame, the sodium cyclamate and the xylitol when being added.

Example 6

The composition is prepared from the following components in parts by weight:

The preparation method of the composition comprises the following steps:

5) Adjusting pH value of the reaction solution obtained in the step 4) to 5.0-7.0 by using 6mol/L hydrochloric acid solution, adding 95% ethanol with volume being 3 times of that of the reaction solution, uniformly stirring, filtering, washing, and taking CMP alcohol precipitate;

7) Dispersing 7.5kg of the CMP crude product in 250L of double distilled water, and adding 6mol/L of sodium hydroxide solution to adjust the pH value to 10.0-13.0; 1.25L of 30% H are added ₂ O ₂ Carrying out a decoloring reaction on the solution at 15 ℃ for 36 hours to remove colored impurities; adding 6mol/L hydrochloric acid solution to adjust pH value to 6.0, centrifuging at 3000 r/min for 30min, collecting filtrate, filtering the filtrate with DH-UF hollow fiber ultrafilter to remove CMP with molecular weight below 0.7 × 104 and trace amount of sodium chloride, sodium chloroacetate and sodium glycolate, adding 95% ethanol with 3 times of filtrate volume, precipitating with ethanol, filtering or centrifuging, drying the CMP ethanol precipitate at 60 deg.C for 4h, drying at 105 deg.C for 2h, and pulverizing to obtain 6.0kg of pure CMP product with carboxymethyl substitution of 1.0:

s2, crushing the pure CMP product and sieving the crushed pure CMP product with a 60-mesh sieve.

S3, adding water accounting for 8 times of the mass of the tuckahoe composite material into other raw materials with the required amount in CMP, stirring and soaking the tuckahoe composite material for 60min;

And S7, adding soluble starch or maltodextrin or a mixture of the soluble starch and the maltodextrin into the seasoned tuckahoe composite powder to enable the whole weight to be 20 times of that of the tuckahoe composite powder, granulating in a wet mixing granulator by adopting a 60-80% ethanol solution to obtain tuckahoe health-care granules, sterilizing the tuckahoe health-care granules, and packaging in bags.

Test example 1Taste test

1. The drinking crowd is as follows: general population

2. Drinking time: ten am point

3. The number of people drinking: 200 persons, 100 persons each per group

4. The method comprises the following steps: 10g of each of the compositions obtained in example 1 and example 4 are taken, 200mL of boiling water is needed for brewing, the brewing time is 15-20 min in a vacuum cup, the composition is tasted at ten am, and the food is not eaten one hour before tasting.

5. Indexes are as follows: after drinking, the tea is obviously cool, slightly bitter and sweet after drinking, the fresh aroma is recorded as good, the cool, slightly bitter and sweet after drinking is light, the aroma is not obvious and recorded as general, the tea is bitter and heavy without sweet after drinking, and the smell is unacceptable and recorded as poor.

6. The results of the mouthfeel tests are shown in table 1.

TABLE 1

	Good taste (crowd)	Taste in general (crowd)	Poor taste (crowd)
				Example 1	80	18	2
Example 4	92	8	0

Test example 2Efficacy comparison test

1. The drinking crowd is as follows: people who are easy to have abdominal distension and indigestion after meals

2. Drinking time: one bag is taken in half an hour in the morning and evening respectively for 15 days

3. The number of people drinking: total 100 persons, 50 persons each

4. The method comprises the following steps: 10g of each of the compositions obtained in the embodiments 1 and 4 are taken, 200mL of boiling water is needed during brewing, the brewing time is that the compositions are processed in a vacuum cup for 15-20 min, and the drinking time is that the compositions are drunk half an hour after meals respectively in the morning and evening.

5. The indexes are as follows: after the Chinese medicinal composition is continuously taken for 15 days, the phenomenon of abdominal distension and indigestion is obviously felt to completely disappear, and the mental state is obviously and effectively improved; the abdominal distension and indigestion phenomenon are relieved after the medicine is continuously taken for 15 days, and the mental state is generally effective to be equal to that before the medicine is taken; after taking the medicine continuously for 15 days, the abdominal distension and indigestion phenomenon is not relieved at all, even aggravated, and the mental state is deteriorated, so that the effect is not effective.

The data are expressed by mean + -standard deviation (X + -S), counting data are tested by X2, grade data are analyzed by Ridit, and metering data are tested by t. The results are shown in Table 2.

TABLE 2

Group of	Number of examples	Clinical control (example)	Obvious effect (example)	Effective (example)	Invalid (example)	Total effective rate (%)
							Example 1	50	0	28	15	7	86*
Example 4	50	0	39	11	0	100*

Note: * P <0.01

The above description of the specific embodiments of the present invention is not intended to limit the present invention, and those skilled in the art may make various changes and modifications according to the present invention without departing from the spirit of the present invention, which is defined in the appended claims.

Claims

1. The poria cocos medicinal composition with the effects of invigorating stomach and eliminating spleen is characterized by comprising the following raw materials in parts by weight: 4-8 parts of poria cocos, 2-5 parts of Chinese yam, 2-5 parts of white hyacinth bean, 2-4 parts of coix seed, 1-3 parts of Chinese date, 1-3 parts of gordon euryale seed, 1-3 parts of fructus amomi, 1-3 parts of dried ginger, 1-4 parts of phaseolus calcaratus, 1-5 parts of orange peel, 1-3 parts of hawthorn, 1-2 parts of malt, 1-4 parts of wrinkled gianthyssop herb, 1-3 parts of elsholtzia, 1-3 parts of heartleaf houttuynia herb, 1-3 parts of dandelion, 1-3 parts of mint, 1-3 parts of purslane, 1-3 parts of chicory, 1-3 parts of perilla leaf and 1-3 parts of cape jasmine.

2. The composition according to claim 1, wherein the poria cocos in the composition is any one of poria cocos coarse powder, pachyman alkalized extract, pachyman, and high-substitution-degree carboxymethyl pachyman (CMP).

3. The composition according to any one of claims 1-2, wherein said highly substituted carboxymethyl pachyman is prepared by a method comprising the steps of: 1) Adding pachymaran into water or water-alcohol mixed solution, stirring, adding alkaline solution with a mass of 1-8% of pachymaran, and stirring to completely dissolve to obtain pachymaran alkalized solution; 2) And (2) after fully reacting 1.0-10mol/L chloroacetic acid with proper excess 2.0-10mol/L alkaline solution, adding the obtained product into the pachyman alkalization solution obtained in the step 1), and performing substitution reaction, separation and purification to obtain the pachyman alkalization solution, wherein the proper excess is that the actual dosage of alkaline substances in the alkaline solution is 0.5-40% more than the theoretical dosage required by the neutralization reaction between the alkaline substances and chloroacetic acid.

4. The composition according to any one of claims 1-3, wherein the pachyman in step 1) is selected from the group consisting of an alkalized extract of pachyman obtained by alkalization extraction or a crude pachyman obtained by acid precipitation with alkali extraction.

5. The composition according to any one of claims 1 to 4, wherein the pachyman alkalizing extract is prepared by adding Poria cocos powder into an alkaline solution having a concentration of 1.0-4.0mol/L to conduct alkalizing extraction, centrifuging, and collecting the supernatant.

6. The composition according to any one of claims 1 to 5, wherein the pachyman is prepared by extracting Poria cocos powder with an alkaline solution having a concentration of 1.0-4.0mol/L under stirring, centrifuging, and collecting the supernatant; adding acid into the supernatant, centrifuging the obtained acid precipitate, and washing with water to obtain pachyman, wherein the acid is selected from one of acetic acid, hydrochloric acid, sulfuric acid, and nitric acid.

7. The composition according to any one of claims 1 to 6, wherein the composition further comprises a desired amount of a pharmaceutically acceptable carrier selected from any one of or a combination of fillers, lubricants, dispersants, wetting agents, binders, conditioning agents, solubilizers, antioxidants, emulsifiers, flavoring agents, and perfuming agents.

8. The composition according to any one of claims 1 to 7, wherein the composition comprises the following raw materials in parts by weight: 4 parts of poria cocos, 2 parts of Chinese yam, 2 parts of white hyacinth beans, 2 parts of coix seeds, 1 part of Chinese dates, 1 part of gordon euryale seeds, 1 part of fructus amomi, 1 part of dried ginger, 2 parts of phaseolus calcaratus, 2 parts of orange peels, 1 part of hawthorn fruits, 1 part of malt, 2 parts of agastache rugosus, 1 part of elsholtzia, 1 part of houttuynia cordata, 1 part of dandelion, 1 part of mint, 1 part of purslane, 1 part of chicory, 1 part of perilla leaves and 1 part of cape jasmine fruits.

9. The preparation method of the poria cocos medicinal composition with stomach and spleen invigorating effects according to any one of claims 1 to 8, wherein the composition comprises the following raw materials in parts by weight: 4-8 parts of poria cocos, 2-5 parts of Chinese yam, 2-5 parts of white hyacinth bean, 2-4 parts of coix seed, 1-3 parts of Chinese date, 1-3 parts of gordon euryale seed, 1-3 parts of fructus amomi, 1-3 parts of dried ginger, 1-4 parts of phaseolus calcaratus, 1-5 parts of orange peel, 1-3 parts of hawthorn, 1-2 parts of malt, 1-4 parts of wrinkled gianthyssop herb, 1-3 parts of elsholtzia, 1-3 parts of heartleaf houttuynia herb, 1-3 parts of dandelion, 1-3 parts of mint, 1-3 parts of purslane, 1-3 parts of chicory, 1-3 parts of perilla leaf and 1-3 parts of gardenia, and the specific preparation method comprises the following steps: all the raw materials are evenly mixed and crushed to 60 to 140 meshes, and then the mixture is sterilized to obtain the feed.

10. Use of the poria cocos pharmaceutical composition as defined in any one of claims 1-8 or the composition prepared by the method as defined in claim 9 for the preparation of a product for improving gastrointestinal function.