CN112972631B - Traditional Chinese medicine composition with functions of improving stomach health and regulating intestinal flora and preparation method thereof - Google Patents

Abstract

The invention relates to a traditional Chinese medicine composition with the functions of improving stomach health and regulating intestinal flora and a preparation method thereof, wherein dendrobium officinale, pennycress and lucid ganoderma are prepared into extracts according to different medicinal material properties, the extracts are compatible with super bifidus factors and super prebiotics xylo-oligosaccharides, and a proper amount of auxiliary materials such as pectin and sodium alginate are added to prepare a composite traditional Chinese medicine microcapsule, so that the functions of improving stomach health and regulating intestinal flora are obviously improved, the stability of functional components such as lucid ganoderma triterpenes, alkaloids, mucopolysaccharides, sesquiterpenes and phenanthraquinones in the traditional Chinese medicine is greatly improved, oxidative rancidity degeneration is prevented, the bioavailability of traditional Chinese medicine components is increased, and the shelf life of the traditional Chinese medicine composition is prolonged; according to the traditional Chinese medicine concept of monarch, minister, assistant and guide, nature, taste, channel tropism and ascending, descending, sinking and floating, the patchouli, the bistort rhizome, the long pepper, the curcuma wenyujin, the alpinia katsumadai, the swertia japonica and the pomegranate rind are combined, the effects of stopping bleeding, easing pain, diminishing inflammation, removing swelling, relieving exterior syndrome, resolving depression and repairing gastrointestinal mucosa are fully developed, and favorable conditions are created for the proliferation of gastrointestinal probiotics.

Description

Traditional Chinese medicine composition with functions of improving stomach health and regulating intestinal flora and preparation method thereof

Technical Field

The invention relates to a traditional Chinese medicine composition with functions of improving stomach health and regulating intestinal flora and a preparation method thereof.

Background

The gastrointestinal tract is used as a digestive organ of a human body, occupies an irreplaceable important position in the metabolism of organism substances, has the functions of secretion, excretion, biotransformation and the like, and can secrete various digestive fluids to participate in the digestive absorption process of food. The intestinal microbial flora such as bifidobacterium, lactobacillus and the like can synthesize various vitamins necessary for the growth and development of human bodies, such as B vitamins, vitamin K, nicotinic acid, pantothenic acid and the like, can also synthesize necessary amino acids such as aspartic acid, phenylalanine, valine, threonine and the like by utilizing protein residues, participate in the metabolism of saccharides and proteins, and can also promote the absorption of mineral elements such as iron, magnesium, zinc and the like, and the nutrients have important effects on the health of human beings. 10 trillion bacteria parasitize in human intestinal tract, which can affect weight and digestion ability, resist infection of pathogenic bacteria and risk of autoimmune disease, promote gastrointestinal tract peristalsis, prevent constipation and diarrhea, promote discharge of harmful substances, and maintain the normal physiological functions of host such as nutrition, immunity and digestion.

With the improvement of daily living standard and the acceleration of life rhythm of people, the change of the food structure and living habits of people is changed with the change of the covering of the earth, the change of the stress mood directly influences the change of the organs of the human body, the most sensitive expression is the stomach and intestine, the adverse mood can cause the dysfunction of the hypothalamus through the cerebral cortex, and the dysfunction of the stomach and intestine is caused by the influence of the gastrointestinal tract function. Irregular diet for a long time, large amount of wine and irritant food, overeating or eating too soon, which can cause gastrointestinal peristalsis dysfunction, irregular gastrointestinal fluid secretion, gastrointestinal mucosa damage and intestinal microecological imbalance. Digestive system diseases exist originally, gastrointestinal disorder occurs, gastrointestinal dysfunction is generated by careless diet, dyspepsia, acute gastroenteritis, ulcer, gastrointestinal perforation and the like are caused in long time. In addition, modern people are under heavy working pressure and often work overtime, which easily causes uncontrollable fatigue, immunity reduction and sub-health state which is difficult to relieve due to insufficient blood supply of gastrointestinal tracts.

Gastropathy is difficult to treat, mainly because the damaged gastric mucosa is not repaired, and the factors inducing mucosa damage are not completely eliminated, mainly caused by helicobacter pylori infection. Long-term, heavy drinking and smoking, irregular diet, roughness and hardness, strong tea, coffee and spicy stimulating food, staying up all night, large mood fluctuation, damage to gastric mucosa barrier by certain medicines such as aspirin, phenylbutazone, glucocorticoid and the like, induction or aggravation of disease, and chemical injury can cause adverse effects on gastrointestinal tract.

China is a large country with gastrointestinal diseases, and the gastrointestinal diseases become main diseases which harm the health of people in China, and even can be one of the big killers which trouble the health of human bodies. Moreover, most people do not pay much attention to the symptoms of acid regurgitation, belching, anorexia, nausea, vomiting, pain, abdominal distension, diarrhea, constipation, bleeding, ulcer, spasm and the like caused by gastrointestinal diseases. Gastrointestinal diseases are slow in onset, and the disease course is prolonged and repeated, so that the gastrointestinal diseases are difficult to cure.

In recent years, most of the drugs for treating gastrointestinal diseases sold in europe, the united states and japan and korea are gastric acid secretion inhibitors: omeprazole, ranitidine, lansoprazole; colloidal bismuth preparation: bismuth pectin, bismuth potassium citrate; antibiotics: amoxicillin, clarithromycin, cefuroxime; gastric acid neutralizing agents: sucralfate, hydrotalcite, aluminum hydroxide, sodium bicarbonate; gastric motility-enhancing drugs: domperidone; pain relieving medicine: acetaminophen, ibuprofen, and the like. The medicines have the main functions of inhibiting acid, sterilizing, easing pain, diminishing inflammation and protecting mucous membranes, have no function of repairing gastric mucosal injury, can only temporarily relieve gastrointestinal symptoms, have no exact curative effect on gastrointestinal injury, treat symptoms and root causes, are easy to relapse, and can cause intestinal microecological imbalance by taking antibiotics for a long time to diminish inflammation, thereby affecting the digestion and absorption of human bodies and the immunoregulation function.

In addition, the traditional Chinese medicine decocting and eating method wastes time and labor, the drug effect is reduced by long-time high-temperature decoction, the bioavailability is not high, the dislike psychology of consumers to drinking the medicine is reduced while the medicine eating amount is reduced, the main functional components of the medicine are retained to the maximum extent, and the technical problems of improving the bioavailability and the drug effect of the medicine are urgently needed to be solved.

Disclosure of Invention

The first technical problem to be solved by the invention is to provide a traditional Chinese medicine composition with the functions of improving the stomach health and adjusting the intestinal flora aiming at the current situation of the prior art, thereby achieving the effects of improving the stomach health and adjusting the intestinal flora without damaging organs, mildly diminishing inflammation and easing pain, repairing mucous membrane tissues, reducing swelling, discharging pus and stopping bleeding, inhibiting the propagation of harmful bacteria, promoting the proliferation of probiotics and reducing or avoiding adverse reactions and side effects to the maximum extent.

The second technical problem to be solved by the present invention is to provide a method for preparing the above traditional Chinese medicine composition with functions of improving stomach health and regulating intestinal flora, aiming at the current situation of the prior art.

The technical scheme adopted by the invention for solving at least one technical problem is as follows:

a traditional Chinese medicine composition with functions of improving stomach health and regulating intestinal flora is characterized in that: the material is prepared from the following raw materials in parts by weight:

preferably, the composite traditional Chinese medicine microcapsule is prepared by adding dendrobium officinale extract, sodium alginate, pectin and xylo-oligosaccharide into ganoderma lucidum concentrated solution and pennycress concentrated solution, and carrying out microencapsulation embedding and spray drying technology treatment; the embedding rate of the functional components in the composite traditional Chinese medicine microcapsule is more than 92%, and the particle size is 140-180 mu m.

The dendrobium officinale is dry stem of dendrobium officinale belonging to the family Orchidaceae, is sweet in taste and slightly cold in nature, enters stomach and kidney channels, is used for treating fever body fluid injury, dry mouth, polydipsia, stomach yin deficiency, anorexia, retching, deficiency heat after disease, yin deficiency, fire excess, bone steaming, fatigue heat, dim and unclear eyes, and weak bones and muscles; the dendrobium officinale is rich in functional components such as alkaloids, mucopolysaccharides, sesquiterpenes, phenanthrenequinones and bibenzyls, can benefit the stomach and promote the production of body fluid, nourish yin and clear heat, moisten the lung and tonify the kidney, improve eyesight and strengthen the waist, and the rich mucopolysaccharides form a stable polysaccharide protective film on the gastrointestinal wall to prevent gastric acid corrosion, so that the dendrobium officinale has the powerful effects of protecting the gastrointestinal mucosa and repairing ulcer.

The Thlaspis arvense is the dry aerial part of the Thlaspis arvense of the Cruciferae family, has pungent and slightly cold flavor, enters liver, stomach and large intestine channels, has the main effects of regulating the middle warmer, promoting diuresis, detoxifying and reducing swelling, and has special effects on stomach pain, stomach swelling and gastric ulcer.

The bistort rhizome is a dry rhizome of bistort rhizome which belongs to Polygonaceae and is bitter, astringent and slightly cold in taste, enters lung, liver and large intestine channels, has the effects of clearing heat and removing toxicity, reducing swelling and stopping bleeding, is mainly used for dysentery heat and diarrhea, carbuncle swelling scrofula, sore bleeding and the like, and has good treatment effect on sore bleeding and ulcer of gastrointestinal tracts.

The patchouli is the dry overground part of the patchouli of the family Labiatae, has pungent and slightly warm taste, enters spleen, stomach and lung channels, can eliminate turbid pathogen with aromatics, regulate the middle warmer, stop vomiting, relieve exterior syndrome and relieve summer-heat, is mainly used for damp turbidity obstruction in middle warmer, epigastric fullness and vomiting, abdominal pain and vomiting and diarrhea, early stage of damp temperature, cold-dampness and heatstroke prevention, can coordinate the functions of gastrointestinal tracts according to the gastrointestinal tracts, relieve exterior syndrome, disperse pathogenic fire and is favorable for eliminating inflammation.

The swertia pseudochinensis is dried whole herb of swertia pseudochinensis Franch of Gentianaceae, and has bitter and cold taste, and enters liver, stomach and large intestine channels. Has effects in clearing away damp-heat, invigorating stomach, nourishing stomach, and relieving inflammation.

The fructus Piperis Longi is dried ear of fructus Piperis Longi of Piperaceae, and has pungent and hot taste, and enters stomach and large intestine meridians. Has effects in warming middle-jiao, dispelling cold, descending qi, and relieving pain, can be used for treating abdominal psychroalgia, emesis, diarrhea, and cold coagulation qi stagnation, and has good effects in relieving pain, and balancing gastrointestinal pain and dysfunction.

The Curcuma wenyujin is dry tuber of Curcuma wenyujin of Zingiberaceae, has pungent, bitter and cold properties, enters liver, heart and lung channels, has effects of promoting blood circulation, relieving pain, activating qi-flowing, resolving stagnation, clearing heart-fire, cooling blood, promoting bile flow, eliminating jaundice, and can be used for swelling and pain, repairing gastrointestinal ulcer, eliminating inflammation, relieving pain and resolving stagnation.

Alpinia katsumadai Hayata is dry and nearly mature seed of Alpinia katsumadai Hayata of Zingiberaceae, and has pungent and warm taste and spleen and stomach meridians entered. The rich volatile oil contains effective components such as alpinetin, pinocembrin, cardamomin, alderone and the like, and can eliminate dampness and promote qi circulation, warm middle energizer and arrest vomiting, eliminate cold-dampness obstruction and belching and vomiting, assist in enhancing the stomach function and improve the stomach health.

Pomegranate rind is the dry epidermis of pomegranate fruit, sour, astringent, warm in taste, and enters the large intestine meridian. Has good effects of relieving diarrhea with astringents, stopping bleeding and expelling parasites, and is helpful for preventing and treating gastrointestinal bleeding and relieving ulcer symptoms.

The dendrobium officinale has the effects of nourishing yin and stomach, repairing mucosa, enhancing immunity and benefiting intestinal tracts; ganoderma has effects in invigorating qi, tranquilizing mind, improving metabolism, regulating immunity, and inhibiting harmful intestinal flora; bistort rhizome and pomegranate rind have the effects of stopping bleeding, relieving swelling, clearing heat and removing toxicity; thlaspis, patchouli, Thlaspis and swertia have the effects of relieving exterior syndrome, nourishing stomach, lowering fire and diminishing inflammation; fructus Piperis Longi and radix Curcumae have effects of relieving pain, promoting blood circulation, activating qi-flowing and resolving stagnation. The Chinese medicinal micro-capsules or the Chinese medicinal extracts are used in combination, so that the miraculous effects of repairing ulcer, reducing swelling, expelling pus, stopping bleeding, diminishing inflammation, relieving pain and promoting the proliferation of gastrointestinal beneficial flora are fully exerted, and the ten medicinal materials are matched according to the formula proportion and used in combination with a specific production and preparation process, so that the synergistic effect can be achieved.

The raw materials of the composition formula disclosed by the invention are dry sporocarp of ganoderma lucidum or ganoderma sinensis in polyporaceae, the ganoderma lucidum is sweet in taste and neutral in nature, and has the effects of tonifying qi, soothing the nerves, relieving cough and asthma, the ganoderma lucidum is rich in functional components such as ganoderma triterpene, ganoderan, ganoderic acid, adenosine, ganoderan and trace elements, the functional components can be used for bidirectionally regulating the functional balance of a human body and regulating the metabolism function of the human body, and the composition is suitable for treating restlessness, deficiency of spleen and stomach, insomnia and palpitation, lung deficiency cough and asthma, consumptive disease and shortness of breath, poor appetite and low immunity; ganoderma can kill helicobacter pylori, inhibit propagation of harmful intestinal flora, promote proliferation of beneficial flora, and maintain gastrointestinal flora balance.

Preferably, the ganoderma lucidum concentrated solution contains more than 25% of ganoderma lucidum polysaccharide and more than 12% of ganoderma lucidum triterpene; the content of mucopolysaccharide in the pennycress concentrated solution is more than 42%; the content of mucopolysaccharide in the dendrobium officinale extract is more than 90%.

Preferably, the patchouli extract/katsumadai seed extract/swertia herb extract is prepared by crushing traditional Chinese medicine decoction pieces of patchouli/katsumadai seed/swertia herb and performing supercritical CO extraction₂Extracting, vacuum freeze drying, and micronizing at low temperature; the patchouli extract contains more than 1.2 percent of patchouli alcohol, the alpinia katsumadai extract contains alpinetin, pinocembrin and cardamomin with the total content of more than 18 percent, and the swertiamarin extract contains more than 36 percent of swertiamarin; the bioavailability of the three traditional Chinese medicine extracts is improved by more than 120 percent compared with the traditional alcohol extraction process.

A preparation method of the traditional Chinese medicine composition with the functions of improving stomach health and regulating intestinal flora is characterized by comprising the following steps:

(1) sequentially extracting Ganoderma and herba Thlaspis, centrifuging, filtering with column, filtering with membrane, and vacuum concentrating to obtain Ganoderma concentrate and herba Thlaspis concentrate;

(2) extracting herba Dendrobii, filtering, concentrating, vacuum freeze drying, and micronizing at low temperature to obtain herba Dendrobii extract;

(3) adding herba Dendrobii extract, sodium alginate, pectin, and xylooligosaccharide into Ganoderma concentrated solution and herba Thlaspis concentrated solution, and microencapsulating and embedding, and spray drying to obtain the composite Chinese medicinal microcapsule;

(4) pulverizing herba Agastaches, herba Swertiae Bimaculatae, and semen Alpiniae Katsumadai respectively, and supercritical CO₂Extracting, vacuum freeze drying, and micronizing at low temperature to obtain herba Agastaches extract, herba Swertiae Bimaculatae extract, and semen Alpiniae extract;

(5) pulverizing rhizoma Bistortae, fructus Piperis Longi, radix Curcumae, and pericarpium Granati respectively, extracting, filtering, vacuum concentrating, and spray drying to obtain rhizoma Bistortae extract, fructus Piperis Longi extract, radix Curcumae extract, and pericarpium Granati extract;

(6) respectively weighing the composite traditional Chinese medicine microcapsules, the patchouli extract, the swertia pseudochinensis extract, the katsumadai seed extract, the bistort rhizome extract, the long pepper extract, the curcuma wenyujin extract and the pomegranate rind extract, putting the components into a three-dimensional mixer according to the formula components, mixing for 10-25 min until the components are completely uniform, mixing the components at a frequency of 15-25 Hz, and sieving the components with a 60-120-mesh sieve to obtain the traditional Chinese medicine composition with the functions of improving the stomach health and regulating the intestinal flora.

Preferably, the ganoderma lucidum concentrate/pennycress concentrate in the step (1) is prepared by the following steps:

(a) slicing: cutting the ganoderma lucidum/pennycress into slices by using a traditional Chinese medicine slicing machine, and controlling the thickness to be 1-4 mm;

(b) extraction and centrifugation: putting the sliced ganoderma/pennycress into a traditional Chinese medicine extraction tank, extracting for 1-3 times at 95-100 ℃ for 1-3 hours each time, adding 8-12 times of medicinal materials, filtering, combining extracting solutions, performing centrifugal separation by a centrifuge at 14000-16000 rpm, removing impurities, and collecting a centrifugal clear liquid;

(c) column filtration: pumping the centrifugal clear liquid into a macroporous adsorption resin column for filtration treatment, and controlling the flow rate to be 8-15L/min to obtain column filtration clear liquid;

(d) and (3) membrane filtration: starting membrane filtration equipment for filtering the clear liquid by the column, filtering the clear liquid by a microporous filter membrane, wherein the thickness of the filter membrane is 60-120 mu m, the pore diameter of the filter membrane is 5-8 mu m, and the operating pressure is 0.15-0.25 MPa, so that the filtrate is clear and transparent, and filter residues are removed; passing the filtered filtrate through an ion exchange column and an active carbon column, performing desalination and decolorization treatment, and removing free amino acid by nanofiltration to obtain membrane filtrate;

(e) and (3) vacuum concentration: and concentrating the membrane filtrate by using a single-effect vacuum drier until the relative density is 1.21-1.28, the concentration temperature is 55-70 ℃, and the vacuum degree is-0.085 to-0.095 Mpa, thus obtaining the ganoderma lucidum concentrate/pennycress concentrate.

The Ganoderma lucidum and Thlaspis arvense adopt double filtration technologies of extraction centrifugation, membrane filtration and column filtration, so that the content of ganoderan in the obtained Ganoderma lucidum concentrated solution is up to more than 25%, and the content of ganoderma triterpene is up to more than 12%; the content of mucopolysaccharide in the obtained pennycress concentrated solution is up to more than 42%, and the bioavailability of the raw materials is improved by 8-14 times compared with that of the crude drug.

Preferably, the dendrobium officinale extract in the step (2) is prepared by the following steps:

(a) cutting into sections: cutting the dendrobium officinale into sections by using a traditional Chinese medicine slicing machine, wherein the length of each section is 20-45 mm;

(b) extracting and filtering: extracting the medicinal materials at 93-96 ℃ for 2-3 times, each time for 1.5-2.5 hours, adding 18-22 times of water, filtering, and combining the extracting solutions;

(c) and (3) vacuum concentration: vacuum concentrating the extract at 62-72 deg.C under-0.080-0.095 Mpa to obtain herba Dendrobii concentrated solution with relative density of 1.04-1.08;

(d) vacuum freeze drying: putting the dendrobium officinale concentrated solution into vacuum freeze drying equipment for drying, and setting parameters as follows: pre-freezing initial temperature of minus 45 ℃ to minus 55 ℃, pre-freezing speed of 0.28 ℃ to 0.45 ℃/min, pre-freezing final temperature of minus 65 ℃, drying chamber pressure of 25 Pa to 40Pa, heating plate temperature of 30 ℃ to 35 ℃, and drying time of 24h to 30h to obtain a freeze-dried extract;

(e) and (3) low-temperature superfine grinding: and (3) crushing the freeze-dried extract into powder by using a low-temperature ultrafine pulverizer, and screening the powder by using a screen of 400-500 meshes to obtain the dendrobium officinale extract.

The dendrobium officinale extract adopts vacuum freeze drying and low-temperature superfine grinding technology, so that the content of mucopolysaccharide in the dendrobium officinale extract is up to more than 90%, and the bioavailability of the raw material is improved by 5-10 times compared with that of the crude drug.

Preferably, the composite traditional Chinese medicine microcapsule in the step (3) is prepared by the following steps:

(a) preparing a wall material: weighing the dendrobium officinale extract, sodium alginate, pectin and xylo-oligosaccharide according to a formula, fully premixing, slowly adding a proper amount of cold water after uniformly mixing, fully stirring, heating to 45-65 ℃, preserving heat, homogenizing at the rotating speed of 4000-6000 rpm until a clear, transparent and uniform wall material solution is formed; the total mass fraction of the dendrobium officinale extract, the sodium alginate, the pectin and the xylo-oligosaccharide in the wall material solution is 2.5-6.0%, and the mass ratio of the dendrobium officinale extract, the sodium alginate, the pectin and the xylo-oligosaccharide is (6-8): 1-2): 0.5-1): 1-2;

(b) preparing a capsule material: weighing the lucid ganoderma concentrated solution and the pennycress concentrated solution, mixing, adding purified water, and continuously stirring until a uniform capsule wall material solution is formed; wherein the ratio of the ganoderma lucidum concentrated solution to the pennycress concentrated solution is (3-5) to (1-2), and the ratio of the total mass of the ganoderma lucidum concentrated solution and the pennycress concentrated solution to the purified water is (2-3) to (5-6);

(c) microcapsule embedding: slowly pouring the capsule material solution prepared in the step (b) into the wall material solution prepared in the step (a), continuously stirring, and performing emulsification and homogenization treatment at the temperature of 40-45 ℃ for 10-15 min, wherein the ratio of the capsule material solution to the wall material solution is (0.9-1.2) to (1.3-1.5), so as to prepare a microcapsule embedding solution;

(d) spray drying: and (3) carrying out spray drying on the prepared microcapsule embedding liquid, wherein the inlet temperature of the spray drying is 165-175 ℃, the outlet temperature of the spray drying is 85-92 ℃, and the feeding speed is 1.2-1.8L/min, so as to prepare the composite traditional Chinese medicine microcapsule.

The composite traditional Chinese medicine microcapsule adopts microencapsulation embedding and spray drying technology for treatment, so that the bioavailability of the obtained composite traditional Chinese medicine microcapsule is greatly improved, the stability of an effective component ganoderma triterpene is also greatly improved, and the annual attenuation rate of the ganoderma triterpene in the shelf life is reduced to below 5%. The embedding rate of the functional components in the composite traditional Chinese medicine microcapsule is more than 92%, and the particle size is 140-180 mu m. The obtained composite traditional Chinese medicine microcapsule has good solubility, good stability to light and heat, and longer shelf life than traditional Chinese medicine mixed powder prepared by directly mixing traditional extracts by more than 12 months.

Preferably, the patchouli extract/swertia herb extract/katsumadai seed extract in the step (4) is prepared by the following steps:

(a) crushing: crushing the patchouli/swertia herb/katsumadai seed into particles, wherein the diameter of the particles is kept between 3 and 5 mm;

(b) supercritical CO₂And (3) extraction: subjecting the above granules to CO₂Extracting by a supercritical extraction method, wherein the entrainer is alcohol with the volume concentration of 40-60%, the addition amount of the entrainer is 8-12% of the feeding amount, the extraction temperature is 32-36 ℃, the extraction pressure is 35-38 Mpa, and CO is used₂The flow is 12-15 kg/h, the extraction time is 90-120 min, the separation pressure is 2-4MPa, and the separation temperature is 35-40 ℃, so that an extraction liquid is obtained;

(c) vacuum freeze drying: putting the extract into a vacuum freeze drying device for drying, wherein the parameters are set as follows: the pre-freezing initial temperature is-35 to-45 ℃, the pre-freezing speed is 0.5 to 0.7 ℃/min, the pre-freezing final temperature is-55 ℃, the pressure of a drying chamber is 50 to 70pa, the temperature of a heating plate is 40 to 42 ℃, and the drying time is 14 to 20 hours, so that the freeze-dried extract is obtained;

(d) and (3) low-temperature superfine grinding: and (3) crushing the freeze-dried extract into powder by using a low-temperature ultrafine pulverizer, and sieving the powder by using a sieve with 450-550 meshes to obtain the patchouli extract/swertia herb extract/katsumadai seed extract.

The herba Agastaches extract, herba Swertiae Bimaculatae extract, and semen Alpiniae Katsumadai extract adopt supercritical CO₂The extraction, vacuum freeze drying and low-temperature superfine grinding are carried out, wherein the content of the functional component patchouli alcohol in the patchouli extract is up to more than 1.2 percent, the total content of the functional components alpinetin, pinocembrin and cardamomin in the alpinia katsumadai seed extract is up to more than 18 percent, the content of the functional component swertiamarin in the swertia pseudochinensis extract is up to more than 36 percent, and the bioavailability of the three traditional Chinese medicine extracts is improved by more than 120 percent compared with the bioavailability of the traditional alcohol extraction process.

Preferably, the bistort rhizome extract/long pepper extract/curcuma wenyujin extract/pomegranate rind extract in the step (5) is prepared by the following steps:

(a) crushing: crushing bistort rhizome/long pepper/turmeric root tuber/pomegranate rind into particles, wherein the diameter of the particles is kept between 5 and 9 mm;

(b) extraction and filtration: putting the granules into a traditional Chinese medicine extraction tank, extracting for 1-2 times at 95-100 ℃, adding 8-12 times of water for 1-2 hours each time, filtering, and combining extracting solutions;

(c) and (3) vacuum concentration: concentrating the extracting solution to the relative density of 1.04-1.08 by using a single-effect vacuum drier, wherein the concentration temperature is 65-75 ℃, and the vacuum degree is-0.085-0.095 Mpa, so as to obtain a medicinal material concentrated solution;

(d) spray drying: and (3) carrying out spray drying on the prepared medicinal material concentrated solution, wherein the inlet temperature of the spray drying is 175-185 ℃, the outlet temperature of the spray drying is 88-95 ℃, and the feeding speed is 1.5-2.0L/min, so that the bistort rhizome extract/long pepper extract/curcuma wenyujin extract/pomegranate rind extract is obtained.

Compared with the prior art, the invention has the advantages that:

according to the invention, dendrobium officinale, pennycress and lucid ganoderma are prepared into extracts through different process flows according to different medicinal material properties, the extracts are compatible with super bifidus factors and super prebiotics xylo-oligosaccharides, and auxiliary materials such as pectin and sodium alginate are added in a proper amount to prepare the composite traditional Chinese medicine microcapsule, so that the synergistic effect is achieved, the functions of improving the stomach health and regulating intestinal flora are obviously improved, the stability of functional components such as lucid ganoderma triterpenoids, alkaloids, mucopolysaccharides, sesquiterpenes and phenanthraquinones in the traditional Chinese medicine is greatly improved, the oxidative rancidity is prevented, the bioavailability of traditional Chinese medicine components is increased, and the shelf life of the traditional Chinese medicine composition is prolonged;

according to the traditional Chinese medicine concept of monarch, minister, assistant and guide, nature, taste, channel tropism and ascending, sinking and rising, the patchouli, the bistort rhizome, the long pepper, the curcuma wenyujin, the katsumadai seed, the swertia japonica and the pomegranate rind are combined, so that the effects of stopping bleeding, relieving pain, diminishing inflammation, removing swelling, relieving exterior syndrome, resolving depression and repairing gastrointestinal tract mucous membranes can be fully developed, favorable geographical conditions are created for the proliferation of gastrointestinal probiotics, the seven medicinal materials are strictly used according to the formula proportion of the traditional Chinese medicine composition, the yin and yang are coordinated, the heat and cold are balanced, the toxicity is removed, the medicine properties are taken, and the synergistic effect can be better achieved; the medicinal materials have small stimulation to the liver and kidney functions of a human body, hardly damage the viscera, and have the peculiar effects of mildness, nourishing, diminishing inflammation, relieving pain and promoting the healing of gastrointestinal mucosa;

aiming at the realistic situation that the composition is eaten in a large amount, the invention respectively crushes the cablin potchouli herb, the swertia japonica and the katsumadai seed and carries out supercritical CO treatment₂Extracting, vacuum freeze drying, and micronizing at low temperature to obtain traditional Chinese medicine extract, wherein patchouli extract contains patchouli alcohol more than 1.2%, semen Alpiniae Katsumadai extract contains alpinetin, pinocembrin and cardamomin more than 18%, swertiamarin more than 36%, and supercritical CO₂The combination of extraction and vacuum freeze drying retains effective components, greatly reduces the edible amount of the medicine, perfectly enriches and protects the effective functional components in the Chinese medicinal materials from being damaged by the heating link in the extraction and concentration process, and ensures the flavor, appearance and color of the materialsThe traditional Chinese medicine extract has unique advantages, can effectively improve the absorption and utilization rate of the body to the active ingredients of the traditional Chinese medicine, and improves the bioavailability of the three traditional Chinese medicine extracts by more than 120 percent compared with the bioavailability of the traditional alcohol extraction process; the ganoderma lucidum and pennycress are subjected to crushing, extraction, centrifugation, column filtration and membrane filtration double filtration and vacuum concentration technology treatment to obtain a ganoderma lucidum concentrated solution and a pennycress concentrated solution, the concentration degree of effective components is greatly improved, the content of ganoderma lucidum polysaccharide in the obtained ganoderma lucidum concentrated solution is up to more than 25%, and the content of ganoderma lucidum triterpene is up to more than 12%; the content of mucopolysaccharide in the obtained pennycress concentrated solution is up to more than 42%, and the composition is remarkably reduced in edible amount, enriched in efficacy and nutritional ingredients, remarkably improved in efficacy and improved in bioavailability of raw materials by 8-14 times compared with that of crude drugs through the treatment of the preparation process; extracting, filtering, concentrating, vacuum freeze-drying and carrying out low-temperature superfine grinding on the dendrobium officinale to obtain the dendrobium officinale extract, wherein the content of mucopolysaccharide in the dendrobium officinale extract is up to more than 90%, and the bioavailability of the raw material is improved by 5-10 times compared with that of the crude drug; the preparation method comprises the steps of adding dendrobium officinale extract, sodium alginate, pectin and xylo-oligosaccharide into ganoderma lucidum concentrated solution and pennycress concentrated solution, and carrying out microencapsulation embedding and spray drying technology treatment, wherein the obtained composite traditional Chinese medicine microcapsule is enriched in efficacy and nutritional ingredients, the efficacy is remarkably improved, the bioavailability is greatly improved, the stability of ganoderma triterpene serving as an efficacy ingredient is also greatly improved, the annual attenuation rate of the ganoderma triterpene within the shelf life is reduced to be below 5%, and the shelf life of the composite traditional Chinese medicine microcapsule is prolonged by more than 12 months compared with traditional Chinese medicine mixed powder prepared by directly mixing traditional extracts. Namely: the preparation method provided by the invention furthest retains the main functional components of the medicines and the food materials, greatly improves the efficacy and the bioavailability while the dosage is obviously reduced, and obviously improves the efficacy.

Detailed Description

The present invention will be described in further detail with reference to examples.

The formula of the embodiment 1-5 of the invention comprises the following components by weight:

	example 1	Example 2	Example 3	Example 4	Example 5
						Composite Chinese medicine microcapsule	36	60	50	36	45
Pogostemon cablin extract	4	9	6	5	9
						Alpinia katsumadai Hayata extract	4	9	5	7	6
Bistort rhizome extract	7	15	12	7	10
						Piper longum extract	4	12	10	5	7
Curcuma wenyujin Y.H.Chen et C.Ling extract	3	10	8	7	6
						Pomegranate rind extract	6	15	7	15	8
Herba Swertiae Bimaculatae extract	1	5	3	4	2

In the above embodiments, the preparation method of the traditional Chinese medicine composition with the functions of improving the stomach health and regulating the intestinal flora comprises the following steps:

(1) sequentially extracting Ganoderma and Thlaspis, centrifuging, column filtering, membrane filtering, and vacuum concentrating to obtain Ganoderma concentrate and Thlaspis concentrate;

specifically, slicing Ganoderma (or Thlaspis arvense) with a traditional Chinese medicine slicing machine to obtain slices with thickness of 2 mm; extracting the decoction pieces in a Chinese medicinal extraction tank at 100 deg.C for 2 times (1.5 hr each time) with water amount of 8 times of the medicinal materials, filtering, mixing extractive solutions, centrifuging at 16000rpm with a centrifuge, removing impurities, and collecting supernatant; pumping the centrifugal clear liquid into a macroporous adsorption resin column for filtration treatment, and controlling the flow rate at 12L/min to obtain column filtration clear liquid; starting membrane filtration equipment for filtering the clear liquid by the column, filtering the clear liquid by a microporous filter membrane, wherein the thickness of the filter membrane is 90 microns, the pore diameter of the filter membrane is 6 microns, the operating pressure is 0.25MPa, ensuring that the filtrate is clear and transparent, and removing filter residues; passing the filtered filtrate through an ion exchange column and an active carbon column, performing desalination and decolorization treatment, and removing free amino acid by nanofiltration to obtain membrane filtrate; concentrating the above membrane filtrate with single-effect vacuum drier to relative density of 1.21, concentrating at 70 deg.C under-0.095 Mpa to obtain Ganoderma concentrate (or Thlaspis concentrate);

(2) extracting herba Dendrobii, filtering, concentrating, vacuum freeze drying, and micronizing at low temperature to obtain herba Dendrobii extract;

specifically, the dendrobium officinale is cut into sections by using a traditional Chinese medicine slicer, and the length of each section is about 35 mm; extracting the above materials at 93 deg.C for 3 times, each time for 1.5 hr, adding water in an amount 20 times of the amount of the materials, filtering, and mixing extractive solutions; vacuum concentrating the extractive solution at 72 deg.C under-0.085 Mpa to obtain herba Dendrobii concentrated solution with relative density of 1.06; putting the dendrobium officinale concentrated solution into vacuum freeze drying equipment for drying, and setting parameters as follows: pre-freezing at-45 deg.C, pre-freezing rate of 0.28 deg.C/min, pre-freezing end point of-65 deg.C, drying chamber pressure of 40pa, heating plate temperature of 35 deg.C, and drying time of 24 hr to obtain lyophilized extract; pulverizing the lyophilized extract into powder by a low-temperature ultrafine pulverizer, and sieving with a 500-mesh sieve to obtain the desired herba Dendrobii extract meeting quality requirements;

(3) adding herba Dendrobii extract, sodium alginate, pectin, and xylooligosaccharide into Ganoderma concentrated solution and herba Thlaspis concentrated solution, and microencapsulating and embedding, and spray drying to obtain the composite Chinese medicinal microcapsule;

specifically, a proper amount of dendrobium officinale extract, sodium alginate, pectin and xylo-oligosaccharide are weighed, fully premixed, slowly added into a proper amount of cold water after being uniformly mixed, fully stirred, heated to 48 ℃ and kept warm, opened and homogenized at the rotating speed of 4000rpm until a clear, transparent and uniform wall material solution is formed, the total mass fraction of the dendrobium officinale extract, the sodium alginate, the pectin and the xylo-oligosaccharide in the wall material solution is 5.2%, and the mass ratio of the dendrobium officinale extract to the sodium alginate to the pectin to the xylo-oligosaccharide is 6: 1: 0.5: 1; weighing appropriate amount of Ganoderma concentrated solution and Thlaspis arvense concentrated solution, mixing, adding appropriate amount of purified water, and continuously stirring to obtain uniform capsule wall material solution. Wherein the ratio of the ganoderma lucidum concentrated solution to the pennycress concentrated solution is 4: 1.5, the ratio of the total mass of the ganoderma lucidum concentrated solution and the pennycress concentrated solution to the purified water is 2: 5; slowly pouring the prepared capsule wall material solution into the prepared wall material solution, continuously stirring, and carrying out emulsification and homogenization treatment at the temperature of 40 ℃ for 10min, wherein the ratio of the capsule wall material solution to the wall material solution is 0.9: 1.5, preparing a microcapsule embedding liquid; spray drying the prepared microcapsule embedding solution at inlet temperature of 168 deg.C, outlet temperature of 85 deg.C, and loading speed of 1.6L/min to obtain required composite Chinese medicinal microcapsule;

(4) pulverizing herba Agastaches, herba Swertiae Bimaculatae, and semen Alpiniae Katsumadai respectively, and supercritical CO₂Extracting, vacuum freeze drying, and micronizing at low temperature to obtain herba Agastaches extract, herba Swertiae Bimaculatae extract, and semen Alpiniae extract;

specifically, the patchouli or swertia herb or katsumadai seed is crushed into particles, and the diameter of the particles is kept at 5 mm; subjecting the granules to CO₂Extracting with supercritical extraction method, wherein the entrainer is 45% (V/V) edible alcohol, the entrainer is added at 12% of the raw materials, the extraction temperature is 32 deg.C, the extraction pressure is 35Mpa, and CO is added₂The flow rate is 12kg/h, the extraction time is 100min, the separation pressure is 3MPa, and the separation temperature is 35 ℃, so that extraction liquid is obtained; putting the extract into a vacuum freeze drying device for drying, and setting parameters as follows:pre-freezing at-35 deg.C, pre-freezing rate of 0.5 deg.C/min, pre-freezing end point of-55 deg.C, drying chamber pressure of 55pa, heating plate temperature of 42 deg.C, and drying time of 16h to obtain lyophilized extract; pulverizing the lyophilized extract into powder by low temperature micronizer, and sieving with 450 mesh sieve to obtain herba Agastaches extract or herba Swertiae Bimaculatae extract or semen Alpiniae extract meeting quality requirement;

(5) pulverizing rhizoma Bistortae, fructus Piperis Longi, radix Curcumae, and pericarpium Granati respectively, extracting, filtering, vacuum concentrating, and spray drying to obtain rhizoma Bistortae extract, fructus Piperis Longi extract, radix Curcumae extract, and pericarpium Granati extract;

specifically, bistort rhizome or long pepper or curcuma wenyujin or pomegranate rind is crushed into particles, and the diameter of the particles is kept at 8 mm; extracting the granules in a Chinese medicinal extraction tank at 100 deg.C for 2 times (1 hr each time) with 10 times of water, filtering, and mixing extractive solutions; concentrating the extractive solution with single-effect vacuum drier to relative density of 1.06, concentrating at 70 deg.C under-0.095 Mpa to obtain medicinal concentrated solution. Spray drying the obtained concentrated solution at inlet temperature of 185 deg.C and outlet temperature of 92 deg.C at feeding speed of 2.0L/min to obtain rhizoma Bistortae extract or fructus Piperis Longi extract or radix Curcumae extract or pericarpium Granati extract meeting quality requirement;

(6) weighing the composite traditional Chinese medicine microcapsules, the patchouli extract, the swertia japonica extract, the alpinia katsumadai extract, the bistort extract, the long pepper extract, the curcuma wenyujin extract and the pomegranate rind extract respectively according to the formula in the embodiment 1-5, putting the weighed materials into a three-dimensional mixer, mixing the materials for 10min to be completely uniform, mixing the materials at the frequency of 15Hz, and sieving the materials with a 60-mesh sieve to obtain the traditional Chinese medicine composition with the functions of improving the stomach health and regulating the intestinal flora.

The efficacy of the Chinese medicinal composition prepared in example 1 of the present invention was verified by the following tests:

1. trial eating of test population

Sample preparation: the traditional Chinese medicine composition prepared in the embodiment 1 of the invention is used as a sample for test feeding, the recommended dose for oral administration by people is 2 times a day, 6g of the composition is taken every time, the composition is taken with warm boiled water, and the total dose taken every day is 12 g.

Inclusion subject criteria: and the test subject is a voluntary subject who is consistent with gastritis or stomachache, gastric acid regurgitation and flatulence.

The evaluation standard of the curative effect is as follows: the traditional Chinese medicine composition has the advantages of curing (clinical symptoms completely disappear, inflammation, flatulence, pain and acid regurgitation completely disappear), obvious effect (clinical symptoms are obviously improved, the occurrence probability of inflammation, flatulence, pain and acid regurgitation is greatly reduced), effectiveness (clinical symptoms are improved, the occurrence probability of inflammation, flatulence, pain and acid regurgitation is reduced occasionally), ineffectiveness (clinical symptoms are not changed or even aggravated), and total effective rate (cure rate + remarkable rate + effective rate).

1.1 general case:

30 test groups of initial test population, 30 negative control groups and 30 positive control groups have normal mental, sleep, diet and excrement states of the testee before and after the test, and no abnormal phenomenon occurs. The number of cases, sex, number of people, age, and course of disease are shown in Table 1. The data in Table 1 shows that the data of three groups of patients has no significant difference, no statistical significance and comparability, and P is more than 0.05.

TABLE 1 comparison of general data of volunteers before tasting

1.2 test methods

The traditional Chinese medicine composition prepared in the embodiment 1 of the invention is taken by a test-feeding group, and the dosage is 12g per day; omeprazole (40 mg/day) + magnesium aluminocarbonate (2000 mg/day) was administered to the positive control group; the negative control group received the same dose of placebo for 21 days. After 21 days, comprehensive analysis is carried out by clinically diagnosing the severity of inflammation and pain and counting the diagnosis data.

1.3 test results

The results data pairs for the three groups of volunteers after the test are shown in table 2:

TABLE 2 comparison of the results of volunteers after test feeding

The results in table 2 show that the test diet group cured 6 cases, showed 12 cases, 10 cases, and had a total effective rate of 86.67%, and the total effective rate of the test diet group was significantly higher than that of the negative control group (P <0.01) and also significantly higher than that of the positive control group. Three groups of patients have no obvious adverse reaction.

1.4 summary

After the test-eating group takes the traditional Chinese medicine composition prepared in the embodiment 1 of the invention according to the specified method and the dosage, the clinical symptoms are greatly improved until the clinical symptoms are fully cured, and the total effective rate is higher than that of a negative control group and a positive control group.

2. Functional mouse test for regulating intestinal flora

Sample preparation: in the experiment, the traditional Chinese medicine composition prepared in the embodiment 1 of the invention is used as a sample for test feeding, the recommended dose for oral administration by people is 2 times a day, 6g of the composition is taken each time, the composition is taken with warm boiled water, and the total dose for oral administration is 12g each day. The human recommended amount of the sample is 12 g/day, the dosage of the sample administration is 1, 3 and 6 times of the human recommended amount in the experiment, three dosage groups of 0.2g/kg, 0.6g/kg and 1.2g/kg are set, and a blank control group is set, so four groups are provided. Each group of experimental animals was given different doses of samples and physiological saline for 4 consecutive weeks.

2.1 Experimental animals

ICR mice, SPF grade, 18 ± 2g, all male, randomly divided into 4 groups of 6 mice each.

2.2 Experimental conditions

The SPF animal house has the temperature of 20-26 ℃, the humidity of 40-70% and the light-dark alternating time of 12h/12 h.

2.3 instruments and reagents

Electronic scale, stomach filling needle, normal saline, buoy, water bath, centrifuge, sterilizing pan, sterilizing gauze, forceps, centrifuge tube, Buffer AL, Inhibit Ex Buffer.

2.4 dose grouping and test sample presentation time

In the animal experiment for regulating intestinal flora by using the traditional Chinese medicine composition prepared in the embodiment 1, three dose groups and a blank control group are designed for samples, four groups are counted, and the three dose groups are 0.2g/kg, 0.6g/kg and 1.2g/kg and are respectively 1, 3 and 6 times of the recommended amount of a human body. The test sample was given for 4 weeks.

2.5 Experimental procedures

2.5.1 Adaptation period

The experimental animal ICR mouse is fed under a barrier system to adapt to the environment for 5-7 days, and the weight of the experimental animal ICR mouse is 25 +/-2 g at the end of the adaptation period.

2.5.2 test sample administration

Each dose group of experimental animals is administered with the same volume of test sample with corresponding dose concentration by intragastric administration every day, and the blank control group is administered with the same volume of normal saline at the same time.

2.5.3 detection index

Weighing the experimental animals once a week, and comparing whether the body weights of the experimental animals in each group have significant difference; and after the sample is administered for the last time, aseptically collecting the anus proximal excrement of the experimental animal to an aseptic centrifuge tube, extracting 16s rDNA according to the experimental steps of the kit, and performing bioinformatics analysis on intestinal flora of the intestinal contents of the mice by a high-throughput sequencing technology.

2.6 data processing and result determination

All data are in mean ± sd

Showing that statistical differences are found when SPSS19 statistical software is used for one-way anova and LSD is used for data comparison between groups, wherein P is less than 0.05.

2.7 results of the experiment

2.7.1 Effect of the Chinese medicinal composition prepared in example 1 of the invention on body weight of Experimental mice

The blank group was given physiological saline, and the experimental group was given different doses of samples. The body weight of the experimental animals was measured, calculated and counted every week for 4 weeks, and the experimental results are shown in Table 3.

The experimental result shows that the weight of each group of mice is uniformly increased after the traditional Chinese medicine composition prepared in the embodiment 1 of the invention is administered for 1 week; a significant decrease in body weight of 1.2g/kg mice 2 weeks after sample administration (p < 0.01); after 3 weeks of sample administration, the body weight of mice in each dose group fluctuated within the normal range; after 4 weeks of sample administration, the blank group gained a little weight and the 1.2g/kg dose group again showed significant differences from the blank control group (p < 0.05).

TABLE 3 Effect of the Chinese medicinal composition prepared in example 1 of the present invention on the body weight of mice

Note: p <0.05, compared to placebo; p <0.01, compared to the blank control group.

2.7.2 the effect of the Chinese medicinal composition prepared in example 1 of the present invention on intestinal microorganisms of experimental mice

2.7.2.1 Effect of the Chinese medicinal composition prepared in example 1 of the present invention on essential flora of health food

Table 4 shows the types of microorganisms necessary for health food testing, and all the raw data are shown in the table. Table 5 shows the statistical results of the corresponding data. The results of the experiment show that the relative amount of enterobacteria in the mice of the blank group of experimental animals before administration is reduced compared with the blank group of administration of the liquid matrix for 4 weeks, and other flora is not significantly changed.

Compared with a blank control group, after the traditional Chinese medicine composition prepared in the embodiment 1 of the invention is administered for 4 weeks, the bifidobacteria in the intestinal tracts of experimental animals of each dose group have an increasing trend; the number of lactobacillus in intestinal tracts of mice in the 1.2g/kg dose group also tends to rise; at the same time the number of clostridia showed a significant decrease (p <0.05) over the 4 week period.

TABLE 4 Effect of the Chinese medicinal composition of the present invention prepared in example 1 on intestinal microorganisms of mice

Note: N.D.: it is not detected.

TABLE 5 Effect of the Chinese medicinal composition prepared in the present invention example 1 on mouse intestinal microorganisms

	Bifidobacterium	Lactobacillus strain	Enterobacter	Enterococcus	Clostridium bacteria
						Before administration	0.0043±0.0012	4.5743±0.8582	0.8947±0.6200*	N.D.	0.0120±0.0095
Blank control	0.0114±0.0027	3.6542±1.3016	0.0525±0.0285	N.D.	0.0254±0.0093
						0.2g/kg	0.0163±0.1362	4.9882±1.7165	0.1188±0.0893	N.D.	0.0093±0.0017
0.6g/kg	0.0574±0.0135	3.083±1.4643	0.3101±0.1311	N.D.	0.0108±0.0016
						1.2g/kg	0.1068±0.0313	6.5065±0.1536	0.4183±0.9453	N.D.	0.0062±0.0026*

Note: p <0.05, p <0.01, compared to the blank control group; # p <0.05, # p <0.01, compared to control group before experiment; note: N.D.: it is not detected.

According to the twenty-four intestinal flora regulation function test method in health food test and evaluation technical specification (2003 edition), the change conditions of bifidobacterium, lactobacillus, enterococcus, enterobacter and clostridium perfringens before and after the experiment are compared, the comparison difference between the experiment group and the experiment group before and after the experiment is significant, or the comparison difference between the experiment group and the control group after the experiment is significant, and the comparison difference between the experiment group and the experiment group before and after the experiment is significant, so that the method meets any one of the following conditions, and can judge that the experimental result of the tested sample animal is positive.

1. The bifidobacteria and/or lactobacilli in the feces are obviously increased, the clostridium perfringens is reduced or not increased, and the enterobacteria and the enterococci are not obviously changed.

2. The stool has significantly increased bifidobacteria and/or lactobacilli, decreased or no clostridium perfringens, and significantly increased enterobacteria and/or enterococci, but at a lower level than the bifidobacteria/lactobacilli.

From the above criteria, in combination with the experimental data of the traditional Chinese medicine composition prepared in embodiment 1 of the present invention on the intestinal flora, it can be known that the traditional Chinese medicine composition prepared in embodiment 1 of the present invention has a tendency of regulating the intestinal flora in the dosage and time range designed by the experiment.

2.7.2.2 analysis of microbial structure of intestinal tract

The sequences of the mouse gut microorganisms are divided mainly at the phylum level into: bacteromycota (Firmicutes), Bacteroides (Bacteroides), Proteobacteria (Proteobacteria), Verrucomicrobia (Verrucomicrobia), Thielavia (Tenericus), Actinomyces (Actinobacterium), Deferribacter (Deferribacteriaceae), and the like, as well as bacteria that are in part of low relative abundance or are not well-defined. Wherein, the relative abundance of Firmicutes, Bacteroides and Proteobacteria is the highest.

On a phylogenetic level, the Candidatus Saccharibacteria in the intestinal flora of experimental animals of each dose group of the traditional Chinese medicine composition prepared in the embodiment 1 of the invention is obviously reduced (p is less than 0.01); acidobacter showed different degrees of significant increase (p <0.05, p <0.01), with the 1.2g/kg group being slightly less elevated than the other two dose groups (Table 6).

TABLE 6 differences in levels of intestinal microbiota in mice resulting from a test feeding of the Chinese medicinal composition

Note: *: p <0.05 compared to blank; p <0.01 compared to blank.

2.8. Conclusion

2.8.1 Effect of the Chinese medicinal composition prepared in example 1 of the present invention on the body weight of mice

The body weight gain rate of each group of experimental mice was slightly inconsistent during the administration of the samples. The traditional Chinese medicine composition prepared in the embodiment 1 of the invention has 1.2g/kg more remarkable influence on the body weight of experimental animals (p is less than 0.05, and p is less than 0.01).

2.8.2 Effect of the Chinese medicinal composition prepared in example 1 of the present invention on the intestinal flora of mice

According to the evaluation standard of the test method for adjusting the functions of the intestinal flora in twenty-four years in the technical specification for health food inspection and evaluation (2003), statistics on the existing experimental results show that the traditional Chinese medicine composition prepared in the embodiment 1 of the invention has the tendency of adjusting the intestinal flora within the time and dosage range designed by the experiment.

On a phylogenetic level, the Candidatus Saccharomyces cerevisiae in the intestinal flora of experimental animals of each dose group of the traditional Chinese medicine composition prepared in the embodiment 1 of the invention is obviously reduced (p is less than 0.01); acidobacter showed different degrees of significant increase except for the 1.2g/kg group (p <0.05, p < 0.01).

The test data show that the traditional Chinese medicine composition has the positive effect of regulating the intestinal flora, can promote the proliferation of probiotics and inhibit the propagation of harmful bacteria, thereby maintaining stable intestinal microecological balance and improving the health of gastrointestinal tracts.

The above description is only a preferred embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications and variations that may be made by the appended claims, or may be made by those skilled in the art without departing from the spirit of the present invention.

Claims (7)

1. A traditional Chinese medicine composition with functions of improving stomach health and regulating intestinal flora is characterized in that: the material is prepared from the following raw materials in parts by weight:

36 to 60 parts of composite traditional Chinese medicine micro-capsules,

4-9 parts of patchouli extract,

4-9 parts of katsumadai seed extract,

7-15 parts of a bistort rhizome extract,

4-12 parts of long pepper extract,

3-10 parts of curcuma wenyujin extract,

6-15 parts of a pomegranate bark extract,

1-5 parts of swertia herb extract;

the composite traditional Chinese medicine microcapsule is prepared by adding dendrobium officinale extract, sodium alginate, pectin and xylo-oligosaccharide into lucid ganoderma concentrated solution and pennycress concentrated solution, and performing microencapsulation embedding and spray drying technology; the embedding rate of the functional components in the composite traditional Chinese medicine microcapsule is more than 92%, and the particle size is 140-180 mu m;

the ganoderma lucidum concentrated solution contains more than 25% of ganoderma lucidum polysaccharide and more than 12% of ganoderma lucidum triterpene; the content of mucopolysaccharide in the pennycress concentrated solution is more than 42%; the content of mucopolysaccharide in the dendrobium officinale extract is more than 90%;

the herba Agastaches extract/semen Alpiniae extract/herba Swertiae Bimaculatae extract is prepared by pulverizing herba Agastaches/semen Alpiniae/herba Swertiae Bimaculatae by traditional Chinese medicine decoction pieces, and supercritical CO₂Extracting, vacuum freeze drying, and micronizing at low temperature; the patchouli extract contains more than 1.2 percent of patchouli alcohol, the alpinia katsumadai extract contains alpinetin, pinocembrin and cardamomin with the total content of more than 18 percent, and the swertiamarin extract contains more than 36 percent of swertiamarin.

2. A method for preparing the Chinese medicinal composition for improving stomach health and regulating intestinal flora according to claim 1, which comprises the following steps:

(1) sequentially extracting Ganoderma and herba Thlaspis, centrifuging, filtering with column, filtering with membrane, and vacuum concentrating to obtain Ganoderma concentrate and herba Thlaspis concentrate;

(2) extracting herba Dendrobii, filtering, concentrating, vacuum freeze drying, and micronizing at low temperature to obtain herba Dendrobii extract;

(3) adding herba Dendrobii extract, sodium alginate, pectin, and xylooligosaccharide into Ganoderma concentrated solution and herba Thlaspis concentrated solution, and microencapsulating and embedding, and spray drying to obtain the composite Chinese medicinal microcapsule;

(4) pulverizing herba Agastaches, herba Swertiae Bimaculatae, and semen Alpiniae Katsumadai respectively, and supercritical CO₂Extracting, vacuum freeze drying, and micronizing at low temperature to obtain herba Agastaches extract, herba Swertiae Bimaculatae extract, and semen Alpiniae extract;

(5) pulverizing rhizoma Bistortae, fructus Piperis Longi, radix Curcumae, and pericarpium Granati respectively, extracting, filtering, vacuum concentrating, and spray drying to obtain rhizoma Bistortae extract, fructus Piperis Longi extract, radix Curcumae extract, and pericarpium Granati extract;

(6) respectively weighing the composite traditional Chinese medicine microcapsules, the patchouli extract, the swertia pseudochinensis extract, the katsumadai seed extract, the bistort rhizome extract, the long pepper extract, the curcuma wenyujin extract and the pomegranate rind extract, putting the components into a three-dimensional mixer according to the formula components, mixing for 10-25 min until the components are completely uniform, mixing the components at a frequency of 15-25 Hz, and sieving the components with a 60-120-mesh sieve to obtain the traditional Chinese medicine composition with the functions of improving the stomach health and regulating the intestinal flora.

3. The method of claim 2, wherein: the ganoderma lucidum concentrated solution/pennycress concentrated solution in the step (1) is prepared by the following steps:

(a) slicing: cutting the ganoderma lucidum/pennycress into slices by using a traditional Chinese medicine slicing machine, and controlling the thickness to be 1-4 mm;

(b) extraction and centrifugation: putting the sliced ganoderma/pennycress into a traditional Chinese medicine extraction tank, extracting for 1-3 times at 95-100 ℃ for 1-3 hours each time, adding 8-12 times of medicinal materials, filtering, combining extracting solutions, performing centrifugal separation by a centrifuge at 14000-16000 rpm, removing impurities, and collecting a centrifugal clear liquid;

(c) and (3) column filtration: pumping the centrifugal clear liquid into a macroporous adsorption resin column for filtration treatment, and controlling the flow rate to be 8-15L/min to obtain column filtration clear liquid;

(d) membrane filtration: starting membrane filtration equipment for filtering the clear liquid by the column, filtering the clear liquid by a microporous filter membrane, wherein the thickness of the filter membrane is 60-120 mu m, the pore diameter of the filter membrane is 5-8 mu m, and the operating pressure is 0.15-0.25 MPa, so that the filtrate is clear and transparent, and filter residues are removed; carrying out desalination and decoloration treatment on the filtered filtrate through an ion exchange column and an active carbon column, and removing free amino acid through nanofiltration to obtain membrane filtrate;

(e) and (3) vacuum concentration: and concentrating the membrane filtrate by using a single-effect vacuum drier until the relative density is 1.21-1.28, the concentration temperature is 55-70 ℃, and the vacuum degree is-0.085 to-0.095 Mpa, thus obtaining the ganoderma lucidum concentrate/pennycress concentrate.

4. The method of claim 2, wherein: the dendrobium officinale extract in the step (2) is prepared by the following steps:

(a) cutting into sections: cutting the dendrobium officinale into sections by using a traditional Chinese medicine slicing machine, wherein the length of each section is 20-45 mm;

(b) extraction and filtration: extracting the medicinal materials at 93-96 ℃ for 2-3 times, each time for 1.5-2.5 hours, adding 18-22 times of water, filtering, and combining the extracting solutions;

(c) and (3) vacuum concentration: vacuum concentrating the extract at 62-72 deg.C under-0.080-0.095 Mpa to obtain herba Dendrobii concentrated solution with relative density of 1.04-1.08;

(d) vacuum freeze drying: putting the dendrobium officinale concentrated solution into vacuum freeze drying equipment for drying, and setting parameters as follows: the pre-freezing initial temperature is-45 to-55 ℃, the pre-freezing speed is 0.28 to 0.45 ℃/min, the pre-freezing final temperature is-65 ℃, the pressure of a drying chamber is 25 to 40pa, the temperature of a heating plate is 30 to 35 ℃, and the drying time is 24 to 30 hours, so that the freeze-dried extract is obtained;

(e) and (3) low-temperature superfine grinding: and (3) crushing the freeze-dried extract into powder by using a low-temperature ultrafine pulverizer, and screening the powder by using a screen of 400-500 meshes to obtain the dendrobium officinale extract.

5. The method of claim 2, wherein: the composite traditional Chinese medicine microcapsule in the step (3) is prepared by the following steps:

(a) preparing a wall material: weighing the dendrobium officinale extract, sodium alginate, pectin and xylo-oligosaccharide according to a formula, fully premixing, slowly adding a proper amount of cold water after uniformly mixing, fully stirring, heating to 45-65 ℃, preserving heat, homogenizing at the rotating speed of 4000-6000 rpm until a clear, transparent and uniform wall material solution is formed; the total mass fraction of the dendrobium officinale extract, the sodium alginate, the pectin and the xylo-oligosaccharide in the wall material solution is 2.5-6.0%, and the mass ratio of the dendrobium officinale extract, the sodium alginate, the pectin and the xylo-oligosaccharide is (6-8): 1-2): 0.5-1): 1-2;

(b) preparing a capsule material: weighing the lucid ganoderma concentrated solution and the pennycress concentrated solution, mixing, adding purified water, and continuously stirring until a uniform capsule wall material solution is formed; wherein the ratio of the ganoderma lucidum concentrated solution to the pennycress concentrated solution is (3-5): 1-2), and the ratio of the total mass of the ganoderma lucidum concentrated solution to the pennycress concentrated solution to the purified water is (2-3): 5-6);

(c) microcapsule embedding: slowly pouring the capsule material solution prepared in the step (b) into the wall material solution prepared in the step (a), continuously stirring, and performing emulsification and homogenization treatment at the temperature of 40-45 ℃ for 10-15 min, wherein the ratio of the capsule material solution to the wall material solution is (0.9-1.2) to (1.3-1.5), so as to prepare a microcapsule embedding solution;

(d) spray drying: and (3) carrying out spray drying on the prepared microcapsule embedding liquid, wherein the inlet temperature of the spray drying is 165-175 ℃, the outlet temperature of the spray drying is 85-92 ℃, and the feeding speed is 1.2-1.8L/min, so as to prepare the composite traditional Chinese medicine microcapsule.

6. The method of claim 2, wherein: the patchouli extract/swertia herb extract/katsumadai seed extract in the step (4) is prepared by the following steps:

(a) crushing: crushing the patchouli/swertia herb/katsumadai seed into particles, wherein the diameter of the particles is kept between 3 and 5 mm;

(b) supercritical CO₂And (3) extraction: subjecting the above granules to CO₂Extracting by a supercritical extraction method, wherein an entrainer is alcohol with the volume concentration of 40-60%, the addition amount of the entrainer is 8-12% of the feeding amount, the extraction temperature is 32-36 ℃, the extraction pressure is 35-38 Mpa, and CO is₂The flow is 12-15 kg/h, the extraction time is 90-120 min, the separation pressure is 2-4MPa, and the separation temperature is 35-40 ℃, so that an extraction liquid is obtained;

(c) and (3) vacuum freeze drying: putting the extract into a vacuum freeze drying device for drying, and setting parameters as follows: pre-freezing initial temperature is minus 35 to minus 45 ℃, pre-freezing speed is 0.5 to 0.7 ℃/min, pre-freezing final temperature is minus 55 ℃, drying chamber pressure is 50 to 70pa, heating plate temperature is 40 to 42 ℃, and drying time is 14 to 20 hours, so as to obtain a freeze-dried extract;

(d) and (3) low-temperature superfine grinding: and (3) crushing the freeze-dried extract into powder by using a low-temperature ultrafine pulverizer, and sieving the powder by using a sieve with 450-550 meshes to obtain the patchouli extract/swertia herb extract/katsumadai seed extract.

7. The method of claim 2, wherein: the bistort extract/long pepper extract/curcuma wenyujin extract/pomegranate rind extract in the step (5) is prepared by the following steps:

(a) crushing: crushing bistort rhizome/long pepper/turmeric root tuber/pomegranate rind into particles, wherein the diameter of the particles is kept between 5 and 9 mm;

(b) extraction and filtration: putting the granules into a traditional Chinese medicine extraction tank, extracting for 1-2 times at 95-100 ℃, adding 8-12 times of water for 1-2 hours each time, filtering, and combining extracting solutions;

(c) and (3) vacuum concentration: concentrating the extracting solution to the relative density of 1.04-1.08 by using a single-effect vacuum drier, wherein the concentration temperature is 65-75 ℃, and the vacuum degree is-0.085 to-0.095 Mpa, so as to obtain a medicinal material concentrated solution;

(d) spray drying: and (3) carrying out spray drying on the prepared medicinal material concentrated solution, wherein the inlet temperature of the spray drying is 175-185 ℃, the outlet temperature of the spray drying is 88-95 ℃, and the feeding speed is 1.5-2.0L/min, so that the bistort rhizome extract/long pepper extract/curcuma wenyujin extract/pomegranate rind extract is obtained.