CN110801470A - Biological medicine and medical food for liver, gallbladder, spleen and pancreas diseases and preparation method - Google Patents

Biological medicine and medical food for liver, gallbladder, spleen and pancreas diseases and preparation method Download PDF

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Publication number
CN110801470A
CN110801470A CN201911227909.XA CN201911227909A CN110801470A CN 110801470 A CN110801470 A CN 110801470A CN 201911227909 A CN201911227909 A CN 201911227909A CN 110801470 A CN110801470 A CN 110801470A
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parts
cordyceps sinensis
powder
placenta
medicine
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骆兴东
曹正雨
高海波
叶亚俊
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Huaian City Huaian Hospital
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Huaian City Huaian Hospital
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06Fungi, e.g. yeasts
    • A61K36/062Ascomycota
    • A61K36/066Clavicipitaceae
    • A61K36/068Cordyceps
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L2/00Non-alcoholic beverages; Dry compositions or concentrates therefor; Their preparation
    • A23L2/385Concentrates of non-alcoholic beverages
    • A23L2/39Dry compositions
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L29/00Foods or foodstuffs containing additives; Preparation or treatment thereof
    • A23L29/06Enzymes
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L31/00Edible extracts or preparations of fungi; Preparation or treatment thereof
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    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/105Plant extracts, their artificial duplicates or their derivatives
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/48Reproductive organs
    • A61K35/50Placenta; Placental stem cells; Amniotic fluid; Amnion; Amniotic stem cells
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
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Abstract

The invention discloses a medical food and biological medicine for treating liver, gallbladder, spleen and pancreas diseases and a preparation method thereof, wherein the medical food and biological medicine are prepared by the following raw materials in parts by weight through crushing, extracting effective substances from parts, specially treating parts, or carrying out enzyme digestion, blending and other treatments, and then preparing into solid beverage, or micropowder, powder, freeze-dried powder, or granules, or suspension, or capsules and other suitable application forms; 0.4-30 parts of cordyceps sinensis or cordyceps sinensis powder, 10-16 parts of salvia miltiorrhiza, 20-40 parts of astragalus membranaceus, 10-20 parts of red paeony root, 1-50 parts of placenta, 0.5-50 parts of carrot, 0.1-39 parts of angelica dahurica, 10-50 parts of liquorice, 9-50 parts of honeysuckle, 0.1-69 parts of radix achyranthis bidentatae, 0.1-29 parts of branched chain amino acid, 0.9-60 parts of maltodextrin, 0.5-30 parts of dietary fiber, 0.01-45 parts of medium-chain triglyceride, 0.1-19 parts of trace elements, 0.1-27 parts of water-soluble vitamin, 0.1-5 parts of fat-soluble vitamin and 0.9-15 parts of flavoring agent. The medical food and the biological medicine have reasonable formula, and can help patients with liver, gallbladder, spleen and pancreas diseases to recover better by effectively improving the immunity and self-repairing ability of the patients.

Description

Biological medicine and medical food for liver, gallbladder, spleen and pancreas diseases and preparation method
Technical Field
The invention belongs to the technical field of biological medicines and medical foods, and particularly relates to a biological medicine and medical food for treating diseases of liver, gallbladder, spleen and pancreas and a preparation method thereof.
Background
At present, the diseases of liver, gallbladder, spleen and pancreas (various inflammations, cancers and the like) are in an increasing trend in Chinese pathogenetic personnel, and most of medicines for treating the diseases have complex prescription composition, so that the product has multiple complex functions on human bodies; or the composition is simple but has a plurality of disadvantages of side effects, which cannot be tolerated by patients; or the patient is required too much in a restrictive way during taking the medicine, the normal work and life of the patient are influenced, and the like, and particularly, the outstanding defects are that various treatment means used at present cannot improve the immunocompetence and the self-repairing capability of the patient, and are not beneficial to the rehabilitation of the body of the patient. The theory of traditional Chinese medicine considers that reasonable dietetic therapy health preservation has good auxiliary treatment effect on liver, gallbladder, spleen and pancreas diseases, and no relevant report is found at present.
Medical food is a novel product different from common food, health care products and medicines, and is food with special medical application which needs to be taken under the guidance of doctors or dieticians; the biological medicine of the present invention relates to biological product, biological preparation and final biological activity possessing special biological medicine preparation.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide the biological medicine and the medical food for the diseases of liver, gallbladder, spleen and pancreas, the formula of the biological medicine and the medical food disclosed by the invention is reasonable, and the immune capability and the self-repairing capability of a patient are effectively improved to help the patient with the diseases of liver, gallbladder, spleen and pancreas to recover better; the invention also aims to provide a preparation method of the biological medicine and medical food.
The invention is realized by the following technical scheme:
a biological medicine for treating diseases of liver, gallbladder, spleen and pancreas is prepared from the following raw materials (by weight parts) by pulverizing, extracting effective components from part, treating part by special treatment, or enzyme cutting, blending, and making into solid beverage, micropowder, powder, lyophilized powder, granule, suspension, or capsule; 0.4-30 parts of cordyceps sinensis or cordyceps sinensis powder, 10-16 parts of salvia miltiorrhiza, 20-40 parts of astragalus membranaceus, 10-20 parts of red paeony root, 1-50 parts of placenta, 0.5-50 parts of carrot, 0.1-39 parts of radix angelicae, 10-50 parts of liquorice, 9-50 parts of honeysuckle, 0.1-69 parts of radix achyranthis bidentatae and 0.1-29 parts of branched chain amino acid.
Preferably, the biological medicine for treating the diseases of liver, gallbladder, spleen and pancreas is prepared by crushing the following raw materials in parts by weight, extracting active substances from parts by weight, specially treating parts by weight, or performing enzyme digestion, blending and other treatments, and preparing into solid beverages, or micropowder, powder, freeze-dried powder, granules, suspensions, capsules and other suitable application forms; 0.5-19 parts of cordyceps sinensis or cordyceps sinensis powder, 11-15 parts of salvia miltiorrhiza, 25-35 parts of astragalus membranaceus, 12-18 parts of red paeony root, 9-39 parts of placenta, 1-39 parts of carrot, 1-29 parts of radix angelicae, 21-39 parts of liquorice, 16-39 parts of honeysuckle, 12-42 parts of radix achyranthis bidentatae and 12-22 parts of branched chain amino acid.
The invention further improves the scheme as follows:
the preparation method of the biological medicine for treating the diseases of liver, gallbladder, spleen and pancreas comprises the following steps:
weighing the raw materials according to the weight part ratio for later use;
(1) extracting oil, putting the salvia miltiorrhiza, the red paeony root, the angelica dahurica and the honeysuckle into a distiller, adding 6 times of water by weight, soaking for 40-70 minutes, distilling for 2.5-3.5 hours, collecting distillate to obtain an oil-water mixture, separating the oil-water mixture to obtain volatile oil, clathrating the volatile oil by β -cyclodextrin with 10 times of weight, clathrating the volatile oil at the temperature of 60 +/-5 ℃ for 2 hours to obtain a clathrate compound, and carrying out liquid-solid separation on the residual materials after distillation to obtain medicine residues and medicine liquid;
(2) extracting fat from the dregs of the step (1) and another bag of clean placenta by ethanol for 2 times, adding 10 times of ethanol with the concentration of 60-85% by weight for the first time, extracting for 1.5-2.5 hours by reflux, adding 8 times of ethanol with the concentration of 60-85% by weight into the filtered dregs of the step, extracting for 1.5-2.5 hours by reflux, combining the two extracting solutions, and recovering the ethanol under the negative pressure state until the extracting solution has no alcohol smell, thus obtaining the liquid containing fat-soluble substances; performing liquid-solid separation on the residual materials after reflux to obtain medicine residues, and recovering residual ethanol in the medicine residues under a negative pressure state until the medicine residues have no alcohol smell;
(3) decocting and extracting the medicine dregs in the step (2) and another bag of cleaned placenta, radix achyranthis bidentatae, carrot, liquorice and astragalus, mixing the medicine dregs with the medicine dregs in the step (2), decocting the medicine dregs for 2 times, each time for 40-70 minutes, adding 8 times of water by weight for the first time and 6 times of water by weight for the second time, combining the medicine liquid obtained after the two times of decoction and filtration and the medicine liquid obtained in the step (1), concentrating the medicine liquid to the relative density of 1.10-1.15 under negative pressure, then adding the inclusion compound in the step (1) and the liquid containing the fat-soluble substances in the step (2), mixing the mixture evenly, and drying the mixture into powder for later use.
(4) Enzyme digestion and separation are carried out on the sorted placenta which is separately packed in the step (3) and decocted, the decocted placenta is fully dried and is micronized by an ultra-high speed pulverizer with 10000 revolutions per hour; taking cordyceps sinensis or cordyceps sinensis powder, micronizing the cordyceps sinensis or cordyceps sinensis powder by a high-speed crushing device at 10000 r/h, respectively slurrying the micronized placenta and the cordyceps sinensis or cordyceps sinensis powder micropowder, respectively carrying out enzyme digestion on the slurried placenta and the cordyceps sinensis or cordyceps sinensis micropowder by using a complex enzyme to respectively obtain placenta short peptide and cordyceps sinensis or cordyceps sinensis powder short peptide with the molecular weight of less than or equal to 3000Da, and respectively separating the placenta short peptide and the cordyceps sinensis or cordyceps sinensis powder short peptide for later use;
(5) and (3) uniformly mixing the placenta short peptide with the molecular weight of less than or equal to 3000Da obtained by enzyme digestion in the step (4), cordyceps sinensis or cordyceps sinensis powder short peptide with the dried powder obtained in the step (3), drying under negative pressure until the water content is less than or equal to 5%, and branching amino acid, or preparing the mixture into solid beverage, dried powder, micropowder, freeze-dried powder, granules, tablets, suspensions and other suitable application forms.
The complex enzyme in the step (4) is a mixture of two or more than two of food-grade acid protease APRL type FDY-2205, acid protease APRS type FDG-2237 and incision type protease FDY-2220.
In the step (4), the temperature of enzyme cutting is 0-69 ℃, the humidity is 39-99%, the illumination intensity is 0-300Lx, and the rotating speed of a centrifuge is 9-75 r/s.
The drying in the step (3) is spray drying in a drying tower, the drying pressure in the drying tower is 100-150Pa, the inlet temperature of the drying tower is 180 +/-5 ℃, and the outlet temperature is 80 +/-5 ℃.
The temperature of the negative pressure concentration in the step (3) is 80 +/-5 ℃; the temperature of the negative pressure drying in the step (5) is 80 +/-5 ℃.
The invention further improves the scheme as follows:
a medical food for treating diseases of liver, gallbladder, spleen and pancreas is prepared from the following raw materials (by weight parts) by pulverizing, extracting effective substances from part, treating part by special treatment, or enzyme cutting, blending, and making into solid beverage, micropowder, powder, lyophilized powder, granule, suspension, or capsule; 0.4-30 parts of cordyceps sinensis or cordyceps sinensis powder, 10-16 parts of salvia miltiorrhiza, 20-40 parts of astragalus membranaceus, 10-20 parts of red paeony root, 1-50 parts of placenta, 0.5-50 parts of carrot, 0.1-39 parts of radix angelicae, 10-50 parts of liquorice, 9-50 parts of honeysuckle and 0.1-69 parts of radix achyranthis bidentatae; the nutrient components (comprising 0.1-29 parts of branched chain amino acid, 0.9-60 parts of maltodextrin, 0.5-30 parts of dietary fiber, 0.01-45 parts of medium chain triglyceride, 0.1-19 parts of trace elements, 0.1-27 parts of water-soluble vitamin, 0.1-5 parts of fat-soluble vitamin and 0.9-15 parts of flavoring agent).
Preferably, the medical food for treating the diseases of liver, gallbladder, spleen and pancreas is prepared by crushing the following raw materials in parts by weight, extracting active substances from parts by weight, specially treating parts by weight, or performing enzyme digestion, blending and other treatments, and preparing into solid beverages, or micropowder, powder, freeze-dried powder, granules, suspensions, capsules and other suitable application forms; 0.5-19 parts of cordyceps sinensis or cordyceps sinensis powder, 11-15 parts of salvia miltiorrhiza, 25-35 parts of astragalus membranaceus, 12-18 parts of red paeony root, 9-39 parts of placenta, 1-39 parts of carrot, 1-29 parts of angelica dahurica, 21-39 parts of liquorice, 16-39 parts of honeysuckle and 12-42 parts of radix achyranthis bidentatae; the nutritional components comprise 12-22 parts of branched chain amino acid, 21-38 parts of maltodextrin, 18-25 parts of dietary fiber, 0.01-29 parts of medium chain triglyceride, 8-16 parts of trace elements, 9-20 parts of water-soluble vitamin, 2-3 parts of fat-soluble vitamin and 8-11 parts of flavoring agent.
The invention has the further improvement scheme that:
the preparation method of the medical food for treating the diseases of liver, gallbladder, spleen and pancreas comprises the following steps:
weighing the raw materials according to the weight part ratio for later use;
(1) extracting oil, putting the salvia miltiorrhiza, the red paeony root, the angelica dahurica and the honeysuckle into a distiller, adding 6 times of water by weight, soaking for 40-70 minutes, distilling for 2.5-3.5 hours, collecting distillate to obtain an oil-water mixture, separating the oil-water mixture to obtain volatile oil, clathrating the volatile oil by β -cyclodextrin with 10 times of weight, clathrating the volatile oil at the temperature of 60 +/-5 ℃ for 2 hours to obtain a clathrate compound, and carrying out liquid-solid separation on the residual materials after distillation to obtain medicine residues and medicine liquid;
(2) extracting fat from the dregs of the step (1) and another bag of clean placenta by ethanol for 2 times, adding 10 times of ethanol with the concentration of 60-85% by weight for the first time, extracting for 1.5-2.5 hours by reflux, adding 8 times of ethanol with the concentration of 60-85% by weight into the filtered dregs of the step, extracting for 1.5-2.5 hours by reflux, combining the two extracting solutions, and recovering the ethanol under the negative pressure state until the extracting solution has no alcohol smell, thus obtaining the liquid containing fat-soluble substances; performing liquid-solid separation on the residual materials after reflux to obtain medicine residues, and recovering residual ethanol in the medicine residues under a negative pressure state until the medicine residues have no alcohol smell;
(3) decocting and extracting the medicine dregs in the step (2) and another bag of cleaned placenta, radix achyranthis bidentatae, carrot, liquorice and astragalus, mixing the medicine dregs with the medicine dregs in the step (2), decocting the medicine dregs for 2 times, each time for 40-70 minutes, adding 8 times of water by weight for the first time and 6 times of water by weight for the second time, combining the medicine liquid obtained after the two times of decoction and filtration and the medicine liquid obtained in the step (1), concentrating the medicine liquid to the relative density of 1.10-1.15 under negative pressure, then adding the inclusion compound in the step (1) and the liquid containing the fat-soluble substances in the step (2), mixing the mixture evenly, and drying the mixture into powder for later use.
(4) Enzyme digestion and separation are carried out on the sorted placenta which is separately packed in the step (3) and decocted, the decocted placenta is fully dried and is micronized by an ultra-high speed pulverizer with 10000 revolutions per hour; taking cordyceps sinensis or cordyceps sinensis powder, micronizing the cordyceps sinensis or cordyceps sinensis powder by a high-speed crushing device at 10000 r/h, respectively slurrying the micronized placenta and the cordyceps sinensis or cordyceps sinensis powder micropowder, respectively carrying out enzyme digestion on the slurried placenta and the cordyceps sinensis or cordyceps sinensis micropowder by using a complex enzyme to respectively obtain placenta short peptide and cordyceps sinensis or cordyceps sinensis powder short peptide with the molecular weight of less than or equal to 3000Da, and respectively separating the placenta short peptide and the cordyceps sinensis or cordyceps sinensis powder short peptide for later use;
(5) and (3) uniformly mixing the placenta short peptide with the molecular weight of less than or equal to 3000Da obtained by enzyme digestion in the step (4), cordyceps sinensis or cordyceps sinensis powder short peptide with the dried powder obtained in the step (3), drying under negative pressure until the water content is less than or equal to 5%, adding nutritional components (including branched chain amino acids, maltodextrin, dietary fibers, medium-chain triglyceride, trace elements, water-soluble vitamins, fat-soluble vitamins and flavoring agents) or preparing the mixture into solid beverage, dried powder, micro powder, freeze-dried powder or granules, or preparing the mixture into tablets, suspensions and other suitable application forms.
The complex enzyme in the step (4) is a mixture of two or more than two of food-grade acid protease APRL type FDY-2205, acid protease APRS type FDG-2237 and incision type protease FDY-2220.
In the step (4), the temperature of enzyme cutting is 0-69 ℃, the humidity is 39-99%, the illumination intensity is 0-300Lx, and the rotating speed of a centrifuge is 9-75 r/s.
The drying in the step (3) is spray drying in a drying tower, the drying pressure in the drying tower is 100-150Pa, the inlet temperature of the drying tower is 180 +/-5 ℃, and the outlet temperature is 80 +/-5 ℃.
The temperature of the negative pressure concentration in the step (3) is 80 +/-5 ℃; the temperature of the negative pressure drying in the step (5) is 80 +/-5 ℃.
The significance of each main component on liver, gallbladder, spleen and pancreas diseases:
and (3) cordyceps sinensis: cordyceps sinensis is a rare medicinal material and enters lung and kidney meridians in the traditional sense. Tonify deficiency, replenish essence and qi, relieve cough and resolve phlegm. It can be used for treating phlegm retention, asthma, tuberculosis, hemoptysis, spontaneous perspiration, night sweat, sexual impotence, spermatorrhea, soreness of waist and knees, and asthenia after illness. Protect lung and tonify kidney, stop bleeding and resolve phlegm, so it is known as chronic cough. It is mainly used for tonifying lung, invigorating kidney yang, treating phlegm-fluid dyspnea and cough (also used for pulmonary fibrosis in modern medicine). According to the invention, through deeply excavating the research results of traditional medicines and modern medicine to cordyceps sinensis, through research, the cordyceps sinensis is found to have the following effects on human bodies: promoting blood circulation, dredging collaterals, regulating and enhancing human immunity; the adaptability and the stress capability of the human body to the external environment are enhanced; improving the resistance, tolerance and adaptability of people to various stimuli with few side effects; the cordycepin and the cordycepic acid are special polysaccharide glycosides and have the special effect of enhancing the repair function of a human body; the dietary fiber of the cordyceps sinensis can better regulate and enhance the gastrointestinal tract function of a human body and reduce the unreasonable absorption of sugar, lipid and cholesterol on one hand, and on the other hand, part of special dietary fiber can regulate and reduce the blood sugar, the blood fat and the cholesterol by adsorbing excessive sugar, lipid and cholesterol ingested by the human body while maintaining the gastrointestinal tract function by using the common dietary fiber; some of them can be decomposed into special components with peculiar functions to human body by intestinal probiotics. The formula of the invention firmly grasps and fully excavates the special and peculiar pharmacological action of the rare medicinal material on human body, combines the related theory of monarch, minister, assistant and guide of the traditional Chinese medicine formula, and combines the characteristics of medicinal materials such as achyranthes bidentata, salvia miltiorrhiza, red peony root, placenta, astragalus mongholicus, angelica dahurica and the like to carry out reasonable formula. Achyranthes root enters liver and kidney meridians and is led to descend, so that the achyranthes root has the effects of strengthening tendons and bones; the red paeony root and the red-rooted salvia root have the effects of promoting blood circulation and are assisted with monarch, minister and other medicines to play the role of protecting the liver and consolidating the foundation; the special function of regulating qi of astragalus is utilized to assist the main drug cordyceps sinensis to play a role in regulating and enhancing the immune function of a human body; the characteristics of placenta entering lung, liver and kidney channels, removing blood stasis, removing stasis, dredging collaterals and curing injury are utilized to cooperate with the effect of guiding various medicines into the liver and the kidney by the radix achyranthis bidentatae and cooperate with effective components of various medicines in a prescription which is enriched in the liver to exert the effects of removing blood stasis, removing stasis, dredging collaterals and managing injury; the therapeutic effects of breaking qi, dispersing glomus, purging phlegm and removing food retention; remove the toxic accumulation in liver and enhance the repair function. It is suitable for basic pathogenesis of chronic hepatitis B. In clinical and experimental research of cirrhosis after hepatitis, the prescription is proved to be capable of improving the immune function and the liver function of a patient (recovering abnormal liver function ALT to be normal) and inhibiting the formation of hepatic fibrosis.
The placenta has the functions of tonifying kidney, replenishing essence, tonifying qi and benefiting blood when a mother gestures a fetus, has sweet and warm nature, has the effects of tonifying qi, tonifying deficiency, warming the middle-jiao, regulating kidney deficiency and emaciation … …, is proved by a large number of experiments by scientists that the placenta caprae seu ovis has the effects of nourishing blood, soothing nerves, enlarging skin, prolonging life and the like, is a nourishing and strengthening medicine for greatly tonifying primordial qi, is also called human placenta, has magical effects which are increasingly known and accepted by people, and researches show that the placenta caprae seu ovis contains various antibodies and interferons, various hormone-like substances, enzymes, erythrogenin, phospholipid, polysaccharides and β -inhibiting factors (macroglobulin which can inhibit influenza viruses), has the effects of enhancing immunity, regulating immunity, enhancing organism, promoting organism body development, enhancing immunity, enhancing organism, promoting vital essence, tonifying kidney, tonifying qi and replenishing vital essence, and enhancing immunity of a fetus, and sexual impotence, and emaciation, and hypofunction of kidney deficiency, and sexual impotence, and hypofunction of a special placenta caprae seu ovine, and sexual impotence, and hypofunction of a special life-induced abortion, and sexual impotence, and sexual.
The pig, the cattle and the sheep are all livestock food for three people in China, and the pure herbivore placenta is the cleanest and the best medicine and food for nourishing yin and enriching blood. Some placenta has basically the same nutrient composition as human placenta, and has reasonable natural structure and rich nutrients including rich protein, 17 kinds of amino acids, 14 kinds of trace elements, phospholipid, lipopolysaccharide, vitamins, active polypeptide related to immunity and normal operation, and natural matching proportion of the nutrients similar to that of human body. Another important reason is that the sheep placenta is not infected by hepatitis virus and the like, and can not generate cross infection with human beings. Other animal placentas (including human placentas) are likely to carry this virus, and in mass production, where only one placentas carry the virus, the risk of the product is conceivable, whereas the use of sheep placentas is relatively much safer.
Radix angelicae: the radix Angelicae Dahuricae is white and pungent in flavor, and enters lung, spleen and stomach meridians. Radix Angelicae Dahuricae has no toxicity in temperature and strong fragrance, and also has fragrant and fragrant herbs, and moves upward to head and eyes, and downward to intestines and stomach, reaches limbs, passes through skin to reach hair orifices, and is favorable for removing pathogenic qi. Radix Angelicae Dahuricae is warm in nature, strong in nature, capable of inducing resuscitation and promoting superficies, capable of activating hand yang-clearing, fragrant in flavor and capable of entering hand taiyin lung meridian, and is used as the principal drug of yang-clearing, wind-heat being pungent and dispelling, and damp-heat being warm and removing. Relieve arsenic toxicity, snake bite, epistaxis, incised wound and incised wound. Can also be used as perfume. The fragrant gas of the angelica dahurica can correct bad taste of placenta, improve taste, facilitate taking, increase compliance, and the unique pharmacological action of the angelica dahurica increases the effects of the prescription on improving the immunity and organism repairing function of patients. The liquorice, the root and the rhizome are used for medicine, are tonifying Chinese herbal medicines, have slight smell and sweet and special taste, and can harmonize the intensity of certain medicines. For example, the flavoring Chengqi decoction can alleviate purgative effect and irritation of radix et rhizoma Rhei and Natrii sulfas to gastrointestinal tract; the hypochlorous acid contained in Glycyrrhrizae radix can block carcinogen from inducing tumor growth.
Honeysuckle flower: honeysuckle also known as Lonicera japonica, also known as honeysuckle, Lonicera japonica, and Lonicera japonica. Is cold in nature and sweet in taste, enters lung, heart and stomach meridians, has the effects of clearing away heat and toxic materials, resisting inflammation, tonifying deficiency and treating wind, and is mainly used for treating diseases such as distending pain, fever due to epidemic febrile disease, toxic heat, carbuncle and ulcer, tumor and the like.
The honeysuckle has the inhibition effect on various pathogenic bacteria and viruses of livestock and poultry. Honeysuckle is known as a good medicine for clearing heat and removing toxicity from old times. It is sweet and cold in nature and fragrant, sweet and cold in nature and clearing heat without hurting stomach, and the fragrance is thorough and can eliminate pathogens. The honeysuckle flower can disperse wind-heat and clear away blood toxin, and has obvious effect on various heat diseases and other diseases.
Honeysuckle is well known for its wide medicinal value since ancient times. The efficacy of the traditional Chinese medicine is mainly to clear away heat and toxic materials and mainly treat epidemic febrile disease fever, heat toxin and bloody dysentery, carbuncle, cellulitis, furuncle and the like. Modern researches prove that the honeysuckle contains pharmacological active ingredients such as chlorogenic acid and luteolin glycoside, has stronger inhibitory power on various pathogenic bacteria such as hemolytic streptococcus, staphylococcus aureus and the like and upper respiratory infection pathogenic viruses and the like, can enhance immunity, resist early pregnancy, protect liver, resist tumor, diminish inflammation, relieve fever, stop bleeding (blood coagulation), inhibit intestinal absorption of cholesterol and the like, has very wide clinical application, and can be used for treating more than 40 diseases such as respiratory infection, bacillary dysentery, acute urinary infection, hypertension and the like by being compatible with other medicines.
Although chlorogenic acid contained in honeysuckle has an allergen effect and can cause allergic reaction, the chlorogenic acid does not cause the allergic reaction when being taken orally, and the chlorogenic acid can be a substance which is converted from small intestinal secretions and has no allergenic activity. The research shows that the honeysuckle has the following functions.
1. The function of resisting pathogenic microorganisms: in vitro experiments show that the flowers and the vines have certain inhibition effects on various pathogenic bacteria such as staphylococcus aureus, hemolytic streptococcus, escherichia coli, dysentery bacillus, vibrio cholerae, typhoid bacillus, paratyphoid bacillus and the like, and are also effective on pneumococcus, meningococcus, pseudomonas aeruginosa and mycobacterium tuberculosis. The water infusion has stronger action than decoction, and the leaf decoction has stronger action than the flower decoction. If the antibacterial agent is used together with fructus forsythiae, the antibacterial ranges can be complemented; the combination of penicillin and penicillin can enhance the antibacterial effect of penicillin on drug-resistant staphylococcus aureus, which is probably a synergistic effect on inhibiting the protein synthesis in bacteria.
2. Anti-inflammatory and antipyretic effects: the injection of flos Lonicerae extract in abdominal cavity is 0.25g/kg, and can inhibit carrageenan foot swelling of rat. In addition, 30-40 g/kg of honeysuckle injection is reported to reduce the degree of egg white foot swelling. The injection of the honeysuckle extract solution into the abdominal cavity for 8g/kg for 2 times/day for 6 consecutive days also has obvious anti-exudation and anti-hyperplasia effects on oily meat bud sacs of croton in rats. Honeysuckle is reported to have obvious antipyretic effect in early days, but cholera bacterin, potato bacillus, hay extract and the like are used for intravenous injection of rabbit ears to generate heat, the antipyretic effect of 5g/kg stomach irrigation of honeysuckle decoction is not proved, and the antipyretic effect is probably related to different honeysuckle preparations, dosages or rabbit tolerance.
3. The function of strengthening the immune function: diluting the honeysuckle decoction to 1: 1280 has effects in promoting phagocytic function of leukocyte. The honeysuckle injection injected into the abdominal cavity of the mouse also has the function of obviously promoting the phagocytic function of inflammatory cells.
4. Central excitability: the experiment methods of electric shock, rotating cage and the like prove that after the chlorogenic acid is orally taken, the central nervous system of animals such as rats, mice and the like can be excited, the action intensity is 1/6 of caffeine, and the combination of the chlorogenic acid and the caffeine does not have addition and enhancement effects.
5. Blood fat reducing effect: the 2.5g/kg of honeysuckle flower for intragastric administration in rats can reduce the absorption of cholesterol in intestines and reduce the content of cholesterol in blood plasma. In vitro experiments also found that honeysuckle can be combined with cholesterol, but Simiaoyongan decoction (honeysuckle, figwort root, angelica and liquorice) treats experimental rabbit atherosclerosis. No effect of reducing blood lipid and aortic wall cholesterol content was observed.
6. Anti-endotoxin: the endotoxin content is determined by a limulus test method, 300% honeysuckle (honeysuckle) injection is diluted by 1: 2-1: 64, and the endotoxin content in a test solution is obviously reduced by an in vitro test by a concave tablet method or a test tube method, wherein the dilution tube of 1: 2-1: 8 is in a liquid state as a negative control tube, and a positive control is in a gel state. 6g/kg of honeysuckle flower (honeysuckle flower) distillate is intravenously injected, the honeysuckle flower (honeysuckle flower) distillate has an antagonistic effect on the rabbit body temperature reduction and the leucocyte number reduction caused by the intravenous injection of 2.8mg/kg of pyocyaneus endotoxin, 7.5g/kg of honeysuckle flower (honeysuckle flower) distillate or 2.5g/kg of injection is intraperitoneally injected, the honeysuckle flower (honeysuckle flower) distillate has a protective effect on mice intraperitoneally injected with 65mg/kg of pyocyaneus endotoxin, and the death rate of the mice is reduced.
7. Other functions are as follows: in vitro screening experiments have reported that water and wine soaking solutions of honeysuckle have obvious cytotoxic effects on sarcoma 180 and ehrlich ascites carcinoma. The honeysuckle extract has a mild prevention effect on experimental gastric ulcer of rats when being taken orally. The oral administration of chlorogenic acid with large dose can increase gastrointestinal motility and promote gastric juice and bile secretion. Chlorogenic acid and its decomposition product have exciting effect on isolated uterus of rat. In addition, chlorogenic acid can slightly enhance the boosting effect of epinephrine and norepinephrine on cats and rats, but has no influence on the prompt membrane reaction of cats.
Licorice root: alias: radix Angelicae Dahuricae, radix Glycyrrhizae, and radix Glycyrrhizae. Leguminous and glycyrrhiza herbs belong to perennial herbs, have strong roots and rhizomes, and are medicinal herbs for supplying medicaments, so the Chinese medicinal herb is a tonifying Chinese herbal medicine. Light smell, sweet and special taste. Clearing away heat and toxic material, expelling phlegm and arresting cough, and relieving epigastric and abdominal pain. Clinically, liquorice is mainly used for heart-qi deficiency, palpitation, intermittent pulse, spleen-stomach qi deficiency, lassitude and hypodynamia and the like; abscess, deep-rooted carbuncle, sore and ulcer, swollen and sore throat, etc. It can be used singly, orally or externally, or combined. For abscess, deep-rooted carbuncle, sores and ulcers, it is often combined with jin Yin Hua and Lian Qiao to play the role of clearing heat and removing toxicity, such as Xian Fang Huo Ming Yin. For swollen and sore throat, it is often combined with Jie Geng, such as Jie Geng Tang. For poisoning by pesticide and food, it is often combined with mung bean or decocted with Fang Feng water for oral administration; asthma and cough. It can be used singly or combined with other herbs. For example, ERCHEN decoction for treating cough due to damp phlegm; ling gan Wu Wei Jiang Xin Tang for treating cough and asthma due to cold-phlegm; mulberry and apricot decoction for treating cough due to dry phlegm; radix Platycodi decoction for treating lung abscess, coughing up saliva, stinking up and purulent phlegm due to heat-toxin; and licorice dry ginger decoction for treating cough, spittle and sialorrhea. It is also often combined with wind-heat cough, wind-cold cough and heat-phlegm cough; stomachache, bellyache, acute gastrocnemius contracture pain and the like, and can obviously enhance the curative effect of treating the acute contracture pain; harmonizing the potency of certain drugs. For example, the flavoring Chengqi decoction can alleviate the purgative effect of Da Huang and Mang Xiao and the irritation to the gastrointestinal tract. In addition, it is commonly used in many prescriptions to coordinate the effects of the drugs; licorice root has the similar effect of adrenocortical hormone. Has inhibitory effect on hyperacidity caused by histamine; has effects in resisting acid and relieving spasm of smooth muscle of stomach and intestine; licoflavone, glycyrrhiza extract and glycyrrhetinic acid have obvious cough relieving effect; the phlegm eliminating effect is also obvious, and the effect strength is glycyrrhizic acid, licoflavone and liquorice extract; has antiinflammatory and antiallergic effects, and can protect inflamed throat and trachea mucosa. The glycyrrhiza extract and glycyrrhizic acid have detoxification effect similar to that of glucuronic acid on certain poisons; because licorice, which contains liquiritigenin, is a hormone-like compound that helps balance the hormone content in the female; the hypochlorous acid contained in Glycyrrhrizae radix can block carcinogen from inducing tumor growth.
The Glycyrrhrizae radix contains multiple chemical components, such as glycyrrhizic acid and liquiritin. The chemical composition of licorice is very complex, and there are dozens of compounds separated from licorice so far, such as glycyrrhizin, glycyrrhetinic acid, liquiritin, isoliquiritin, neoliquiritin, neoisoliquiritin, liquiritigenin, and glycyrrhizin, glycyrol, isoliquiritigenin, 7-methyl coumarine, umbelliferone, etc., but these components and amounts usually vary depending on factors such as the type of licorice, the planting area, the harvesting time, etc. A large number of researches show that glycyrrhizin and flavonoids are the most important physiological active substances in liquorice and mainly exist in the part inside the epidermis of liquorice root.
The liquorice root adopted by the invention can harmonize the intensity of certain medicines. For example, the flavoring Chengqi decoction can alleviate purgative effect and irritation of radix et rhizoma Rhei and Natrii sulfas to gastrointestinal tract; the honeysuckle can enhance the immunity of the organism and enhance the antivirus function of the organism; the ginger has the functions of warming the middle-jiao and harmonizing the stomach, and relieving the bad smell of various fishy smell medicinal materials from causing bad stimulation to human bodies. Therefore, the invention uses the liquorice, the honeysuckle and the ginger to harmonize the bad stimulation of strong fishy smell of the placenta to the taste and the stomach and intestine of people, simultaneously reduces the adverse side effect of other medicinal materials such as the placenta to the human body and increases the curative effect and the medication safety of the preparation by a series of physiological and biochemical processes such as enhancing the immunity of the organism and the like after the preparation is taken.
Carrot: the nutritious home-made vegetable is called as "Xiao ren". The carrot is rich in saccharide, fat, carotene, vitamin A, and vitamin B1Vitamin B2The anthocyanin, the calcium, the iron and other nutrient components have the functions of warming the middle-jiao and harmonizing the stomach and relieving the bad fishy smell of the fishy smell medicinal materials from the bad stimulation to the human body.
Achyranthes bidentata: achyranthes root is a common bulk Chinese medicinal material and is one of the famous four great traditional Chinese medicines. Bitter, sweet, sour and neutral in flavor, entering liver and kidney meridians. Contains a large amount of alkaloid. Tonify liver and kidney, strengthen waist and knees, and has the effects of tonifying liver and kidney, strengthening bones and muscles, dredging channels and collaterals and dissipating blood stasis. It is mainly used for treating cold-dampness flaccid paralysis, and can be taken for a long time to lighten body and resist aging. It is good at tonifying liver and kidney, and is suitable for people with hypoimmunity, weak constitution, hypertension, hyperlipidemia, hypertension and various liver diseases. Deficient in zinc and manganese. Osteoporosis, osteomalacia, muscle twitching, spasticity. Patients with cholelithiasis, renal calculus, bladder calculus and urethral calculus. It is clinically used to treat deficiency of liver and kidney, cold-dampness, pain of bones in waist and knees, soreness and weakness of waist and knees, spasm of limbs, etc.
The invention has the beneficial effects that:
the invention relates to a method for improving the immunity of a patient and the self-repairing ability of the patient to various wounds, which aims to improve the immunity and the self-repairing ability of the patient to the maximum extent. While correcting many of the conditions caused by malnutrition or malnutrition in patients, and remedial interventions to remedy the loss of interest with other traditional therapies.
The medical food provided by the invention can be used for treating and/or assisting in treating the diseases by improving the immunocompetence and self-repairing capability of the patient, correcting malnutrition of the patient or a plurality of diseases caused by nutrient imbalance and performing remedial intervention by using other traditional treatment means, has the advantages of definite curative effect, small side effect, low treatment cost and the like compared with other treatment methods, has less restrictive requirements on the patient in the treatment process, and does not influence normal work and life.
Third, chronic hepatitis B has a long course of disease and complicated conditions, and we believe that blood stasis plays an important role in the evolution process of chronic hepatitis B. Therefore, the treatment is advocated mainly by activating blood and dissolving stasis, and strengthening body resistance and consolidating constitution. The formula provided by the invention comprises cordyceps sinensis (or cordyceps sinensis powder), salvia miltiorrhiza, sheep placenta, carrots, angelica dahurica, liquorice, honeysuckle, astragalus membranaceus, red paeony root, branched chain amino acid, radix achyranthis bidentatae and other medicines for strengthening the body resistance and removing blood stasis, wherein the cordyceps sinensis is a famous and precious medicinal material and enters the lung channel and the kidney channel in the traditional sense. Tonify deficiency, replenish essence and qi, relieve cough and resolve phlegm. It can be used for treating phlegm retention, asthma, tuberculosis, hemoptysis, spontaneous perspiration, night sweat, sexual impotence, spermatorrhea, soreness of waist and knees, and asthenia after illness. Protect lung and tonify kidney, stop bleeding and resolve phlegm, so it is known as chronic cough. It is mainly used for tonifying lung, invigorating kidney yang, treating phlegm-fluid dyspnea and cough (also used for pulmonary fibrosis in modern medicine). The biological medicine provided by the invention can improve the fibrosis condition and HBVM of patients with hepatic fibrosis. The indexes of four liver fibers (LN, HA, PC III, IV-C) and HBVM caused by the medical food provided by the invention are improved, and the medical food is mainly benefited by respectively improving the autoimmune capability and the self-repairing capability of an organism through cordyceps sinensis (or cordyceps sinensis powder), salvia miltiorrhiza, astragalus, red paeony root, sheep placenta, carrot, angelica dahurica, liquorice, honeysuckle, radix achyranthis bidentatae, branched chain amino acid and the like on the basis of improving endogenous immune factors in the body by utilizing the placenta short peptide, and giving corresponding intervention in the aspects of soothing the liver, regulating the liver, benefiting the gallbladder, regulating qi and the like, so that a better clinical effect is finally obtained.
By deeply excavating the research results of the traditional medicine and the modern medicine and pharmacology on the cordyceps sinensis, the research shows that the cordyceps sinensis (or cordyceps sinensis powder) has the following effects on a human body: promoting blood circulation, dredging collaterals, regulating and enhancing human immunity; the adaptability and the stress capability of the human body to the external environment are enhanced; improving the resistance, tolerance and adaptability of people to various stimuli with few side effects; cordyceps acid and cordycepin are special polysaccharide glycoside, and have special effect of enhancing repairing function of human body; the dietary fiber of the cordyceps sinensis (or cordyceps sinensis powder) can better regulate and enhance the gastrointestinal tract function of a human body and reduce the unreasonable absorption of sugar, lipid and cholesterol on one hand, and on the other hand, part of special dietary fiber can regulate and reduce the blood sugar, the blood fat and the cholesterol by adsorbing excessive sugar, lipid and cholesterol ingested by the human body while maintaining the function of the general dietary fiber on the gastrointestinal tract; some of them can be decomposed into special components with peculiar functions to human body by intestinal probiotics. The formula of the invention firmly grasps and fully excavates the special and peculiar pharmacological action of the rare medicinal material on human body, combines the relevant theories of monarch, minister, assistant and guide ascending, descending, sinking and floating of the traditional Chinese medicinal composition, and combines the characteristics of the medicaments of salvia miltiorrhiza, sheep placenta, carrot, angelica dahurica, liquorice, honeysuckle, astragalus, red paeony root, branched chain amino acid and the like, thereby achieving reasonable formula. The effects of activating blood and promoting blood circulation of the red paeony root and the red-rooted salvia root are utilized to assist the monarch, minister and other drugs to play the role of protecting liver and consolidating foundation; the special function of regulating qi of astragalus is utilized, and the auxiliary main medicines of cordyceps sinensis (or artificial culture product thereof), sheep placenta, radix achyranthis bidentatae and the like play roles in regulating and enhancing the immunologic function and the self-repairing capability of a human body; the characteristics of the achyranthes root which enters the liver, the kidney and the spleen and has the functions of removing blood stasis, removing stasis, dredging collaterals and curing injuries are utilized to cooperate with each other to remove blood stasis, remove stasis, dredge collaterals and manage injuries; the therapeutic effects of breaking qi, dispersing glomus, purging phlegm and removing food retention; remove the toxic accumulation accumulated in the pathological tissue and enhance the repair function. It is suitable for treating basic pathogenesis of liver, gallbladder, spleen and pancreas diseases.
According to the invention, corresponding preparation processes are formulated according to different characteristics of the effective components of the medicinal materials in the prescription, so that the problem of sufficient and effective extraction and separation of the effective components of the medicinal materials in the prescription is solved fundamentally.
1. In the extraction operation, firstly, salvia miltiorrhiza, red paeony root, angelica dahurica and honeysuckle which contain volatile components such as volatile oil in a prescription are extracted by a proper mode (an example of steam distillation is given in the document) to obtain volatile oil, the volatile oil is subjected to inclusion by adopting an β -cyclodextrin inclusion technology to prevent the volatile active components from volatilizing and escaping to cause loss, then fat-soluble substances are extracted by a proper mode (an example of ethanol leaching and refluxing is given in the document), then the 'dregs of a decoction' after the active components are extracted are combined with placenta (additionally wrapped) in the prescription, carrot, liquorice and astragalus mongholicus, the active components are extracted by a 'water extraction method', and finally the extracts are combined to enter the next operation.
2. Concentration and drying of the extract, the extract of the present invention is concentrated and dried in a suitable manner (examples are given in this document using low temperature (75-80 ℃ C.), concentration under reduced pressure, and low temperature (75-80 ℃ C.), drying under reduced pressure), and the extract can be concentrated and dried by a suitable manner such as freeze-drying.
3. The cordyceps sinensis (or an artificial culture product thereof) in the prescription is a main (monarch) medicament, and the two medicaments are directly used as medicaments because the polypide and the sporophyte can be directly used as medicaments, the placenta is a ministerial medicament and can also be directly used as medicaments, so that the damage of effective components and unnecessary loss and waste are prevented;
4. in order to fully utilize the modern scientific and technological achievements, the cordyceps sinensis (or the artificial culture product thereof) and the placenta are respectively cut by enzyme to respectively prepare corresponding short peptides, and the short peptides are used as the medicines, so that the waste caused by the 'bioavailability' problem generated by digestion and absorption is reduced, and more importantly, the recent research achievement of improving the immunity and the repair capability of people is improved by utilizing the special biological activity of the short peptides per se, and the effect of curing diseases is improved. Mixing with other medicinal anhydrous extracts, and making into solid beverage, micropowder, powder, suspension, granule, capsule, etc.
5. The invention can ensure the effective quality of the preparation without biological pollution by controlling the moisture of the finished product to be less than 5 percent.
Through the preparation measures, the loss of effective components such as volatile oil possibly caused in production operation is effectively avoided, the quality of the preparation and the quality of products are ensured, and the drug effect is improved.
Detailed Description
Example 1: preparation of biological medicine for liver, gallbladder, spleen and pancreas diseases
Weighing the following raw materials in parts by weight for later use:
10 parts of cordyceps sinensis, 12 parts of salvia miltiorrhiza, 30 parts of astragalus membranaceus, 16 parts of red paeony root, 25 parts of sheep placenta, 21 parts of carrot, 15 parts of angelica dahurica, 30 parts of liquorice, 30 parts of honeysuckle, 32 parts of radix achyranthis bidentatae and 16 parts of branched chain amino acid;
(1) extracting oil, putting the salvia miltiorrhiza, the red paeony root, the angelica dahurica and the honeysuckle into a distiller, adding 6 times of water by weight, soaking for 40-70 minutes, distilling for 2.5-3.5 hours, collecting distillate to obtain an oil-water mixture, separating the oil-water mixture to obtain volatile oil, clathrating the volatile oil by β -cyclodextrin with 10 times of weight, clathrating the volatile oil at the temperature of 60 +/-5 ℃ for 2 hours to obtain a clathrate compound, and carrying out liquid-solid separation on the residual materials after distillation to obtain medicine residues and medicine liquid;
(2) extracting fat, namely performing reflux extraction on the medicine dregs obtained in the step (1) and another bag of cleaned placenta for 2 times by using ethanol, adding 10 times of 60-85% ethanol by weight for the first time, performing reflux extraction for 1.5-2.5 hours, adding 8 times of 60-85% ethanol by weight into the filtered medicine dregs, performing reflux extraction for 1.5-2.5 hours, combining the two extracting solutions, and recovering the ethanol under a negative pressure state until the extracting solution has no alcohol smell to obtain liquid containing fat-soluble substances; carrying out liquid-solid separation on the residual materials after the reflux to obtain medicine residues, and recovering residual ethanol in the medicine residues under a negative pressure state until the medicine residues have no alcohol smell; (ii) a
(3) Decocting and extracting the residues obtained in the step (2) until no alcohol smell exists, mixing the residues with another bag of cleaned placenta, radix achyranthis bidentatae, carrots, liquorice and astragalus membranaceus, decocting for 2 times, each time for 40-70 minutes, adding 8 times of water by weight for the first time, adding 6 times of water by weight for the second time, combining the liquid medicines obtained in the two times of decoction and filtration and the liquid medicine obtained in the step (1), concentrating under negative pressure until the relative density is 1.10-1.15, and then concentrating under negative pressure at the temperature of 80 +/-5 ℃; the temperature of the negative pressure drying in the step (5) is 80 +/-5 ℃; and (3) adding the inclusion compound in the step (1) and the liquid containing the fat-soluble substance in the step (2), uniformly mixing, and then carrying out spray drying in a drying tower, wherein the drying pressure in the drying tower is 100-150Pa, the inlet temperature of the drying tower is 180 +/-5 ℃, the outlet temperature of the drying tower is 80 +/-5 ℃, and drying into powder for later use.
(4) Enzyme digestion and separation are carried out on the sorted placenta which is separately packed in the step (3) and decocted, the decocted placenta is fully dried and is micronized by an ultra-high speed pulverizer with 10000 revolutions per hour; taking cordyceps sinensis or cordyceps sinensis powder, micronizing the cordyceps sinensis or cordyceps sinensis powder by a high-speed grinding device at 10000 r/h, respectively liquefying the micronized placenta and cordyceps sinensis or cordyceps sinensis powder micropowder slurry, and respectively carrying out enzyme digestion on the liquefied placenta and the cordyceps sinensis or cordyceps sinensis micropowder by using a composite enzyme of food-grade acid protease APRL type FDY-2205, acid protease APRS type FDG-2237 and endo-type protease FDY-2220; the temperature of enzyme digestion is 0-69 ℃, the humidity is 39-99%, the illumination intensity is 0-300Lx, and the rotating speed of a centrifuge is 9-75 r/s;
(5) and (3) uniformly mixing the placenta short peptide with the molecular weight of less than or equal to 3000Da obtained by enzyme digestion in the step (4), cordyceps sinensis or cordyceps sinensis powder short peptide with the dried powder obtained in the step (3), drying under negative pressure until the water content is less than or equal to 5%, and adding branched chain amino acid, or preparing into solid beverage, dried powder, micropowder, freeze-dried powder, granules, tablets, suspensions and other suitable application forms.
Example 2: preparation of biological medicine for liver, gallbladder, spleen and pancreas diseases
Weighing the following raw materials in parts by weight for later use:
0.4 part of cordyceps sinensis powder, 10 parts of salvia miltiorrhiza, 20 parts of astragalus membranaceus, 10 parts of red paeony root, 1 part of placenta, 0.5 part of carrot, 0.1 part of angelica dahurica, 10 parts of liquorice, 9 parts of honeysuckle, 0.1 part of radix achyranthis bidentatae and 0.1 part of branched chain amino acid;
the complex enzyme is food-grade acid protease APRL type FDY-2205 and acid protease APRS type FDG-2237;
the rest of the procedure was the same as in example 1.
Example 3: preparation of biological medicine for liver, gallbladder, spleen and pancreas diseases
Weighing the following raw materials in parts by weight for later use:
30 parts of cordyceps sinensis, 16 parts of salvia miltiorrhiza, 40 parts of astragalus membranaceus, 20 parts of red paeony root, 50 parts of placenta, 50 parts of carrot, 39 parts of angelica dahurica, 50 parts of liquorice, 50 parts of honeysuckle, 69 parts of radix achyranthis bidentatae and 29 parts of branched chain amino acid;
the complex enzyme is a mixture of acidic protease APRS type FDG-2237 and endo-type protease FDY-2220;
the rest of the procedure was the same as in example 1.
Example 4: preparation of medical food for treating diseases of liver, gallbladder, spleen and pancreas
Weighing the following raw materials in parts by weight for later use:
10 parts of cordyceps sinensis, 12 parts of salvia miltiorrhiza, 30 parts of astragalus membranaceus, 16 parts of red paeony root, 25 parts of sheep placenta, 21 parts of carrot, 15 parts of angelica dahurica, 30 parts of liquorice, 30 parts of honeysuckle and 32 parts of radix achyranthis bidentatae; the nutritional components comprise 16 parts of branched chain amino acid, 29 parts of maltodextrin, 21 parts of dietary fiber, 9 parts of medium chain triglyceride, 12 parts of trace elements, 15 parts of water-soluble vitamin, 2 parts of fat-soluble vitamin and 10 parts of flavoring agent;
(1) extracting oil, putting the salvia miltiorrhiza, the red paeony root, the angelica dahurica and the honeysuckle into a distiller, adding 6 times of water by weight, soaking for 40-70 minutes, distilling for 2.5-3.5 hours, collecting distillate to obtain an oil-water mixture, separating the oil-water mixture to obtain volatile oil, clathrating the volatile oil by β -cyclodextrin with 10 times of weight, clathrating the volatile oil at the temperature of 60 +/-5 ℃ for 2 hours to obtain a clathrate compound, and carrying out liquid-solid separation on the residual materials after distillation to obtain medicine residues and medicine liquid;
(2) extracting fat, namely performing reflux extraction on the medicine dregs obtained in the step (1) and another bag of cleaned placenta for 2 times by using ethanol, adding 10 times of 60-85% ethanol by weight for the first time, performing reflux extraction for 1.5-2.5 hours, adding 8 times of 60-85% ethanol by weight into the filtered medicine dregs, performing reflux extraction for 1.5-2.5 hours, combining the two extracting solutions, and recovering the ethanol under a negative pressure state until the extracting solution has no alcohol smell to obtain liquid containing fat-soluble substances; carrying out liquid-solid separation on the residual materials after the reflux to obtain medicine residues, and recovering residual ethanol in the medicine residues under a negative pressure state until the medicine residues have no alcohol smell; (ii) a
(3) Decocting and extracting the residues obtained in the step (2) until no alcohol smell exists, mixing the residues with another bag of cleaned placenta, radix achyranthis bidentatae, carrots, liquorice and astragalus membranaceus, decocting for 2 times, each time for 40-70 minutes, adding 8 times of water by weight for the first time, adding 6 times of water by weight for the second time, combining the liquid medicines obtained in the two times of decoction and filtration and the liquid medicine obtained in the step (1), concentrating under negative pressure until the relative density is 1.10-1.15, and then concentrating under negative pressure at the temperature of 80 +/-5 ℃; the temperature of the negative pressure drying in the step (5) is 80 +/-5 ℃; and (3) adding the inclusion compound in the step (1) and the liquid containing the fat-soluble substance in the step (2), uniformly mixing, and then carrying out spray drying in a drying tower, wherein the drying pressure in the drying tower is 100-150Pa, the inlet temperature of the drying tower is 180 +/-5 ℃, the outlet temperature of the drying tower is 80 +/-5 ℃, and drying into powder for later use.
(4) Enzyme digestion and separation are carried out on the sorted placenta which is separately packed in the step (3) and decocted, the decocted placenta is fully dried and is micronized by an ultra-high speed pulverizer with 10000 revolutions per hour; taking cordyceps sinensis or cordyceps sinensis powder, micronizing the cordyceps sinensis or cordyceps sinensis powder by a high-speed grinding device at 10000 r/h, respectively liquefying the micronized placenta and cordyceps sinensis or cordyceps sinensis powder micropowder slurry, and respectively carrying out enzyme digestion on the liquefied placenta and the cordyceps sinensis or cordyceps sinensis micropowder by using a composite enzyme of food-grade acid protease APRL type FDY-2205, acid protease APRS type FDG-2237 and endo-type protease FDY-2220; the temperature of enzyme digestion is 0-69 ℃, the humidity is 39-99%, the illumination intensity is 0-300Lx, and the rotating speed of a centrifuge is 9-75 r/s;
(5) and (3) uniformly mixing the placenta short peptide with the molecular weight of less than or equal to 3000Da obtained by enzyme digestion in the step (4), cordyceps sinensis or cordyceps sinensis powder short peptide with the dried powder obtained in the step (3), drying under negative pressure until the water content is less than or equal to 5%, adding nutritional components (including branched chain amino acids, maltodextrin, dietary fibers, medium-chain triglyceride, trace elements, water-soluble vitamins, fat-soluble vitamins and flavoring agents) or preparing the mixture into solid beverage, dried powder, micro powder, freeze-dried powder or granules, or preparing the mixture into tablets, suspensions and other suitable application forms.
Example 5
Weighing the following raw materials in parts by weight for later use:
0.4 part of cordyceps sinensis powder, 10 parts of salvia miltiorrhiza, 20 parts of astragalus membranaceus, 10 parts of red paeony root, 1 part of placenta, 0.5 part of carrot, 0.1 part of angelica dahurica, 10 parts of liquorice, 9 parts of honeysuckle and 0.1 part of radix achyranthis bidentatae; the nutritional component comprises 0.1 part of branched chain amino acid, 0.9 part of maltodextrin, 0.5 part of dietary fiber, 0.01 part of medium chain triglyceride, 0.1 part of trace element, 0.1 part of water-soluble vitamin, 0.1 part of fat-soluble vitamin and 0.9 part of flavoring agent;
the complex enzyme is food-grade acid protease APRL type FDY-2205 and acid protease APRS type FDG-2237;
the rest of the procedure was the same as in example 4.
Example 6
Weighing the following raw materials in parts by weight for later use:
30 parts of cordyceps sinensis, 16 parts of salvia miltiorrhiza, 40 parts of astragalus membranaceus, 20 parts of red paeony root, 50 parts of placenta, 50 parts of carrot, 39 parts of angelica dahurica, 50 parts of liquorice, 50 parts of honeysuckle and 69 parts of radix achyranthis bidentatae; the nutritional components comprise 29 parts of branched chain amino acid, 60 parts of maltodextrin, 30 parts of dietary fiber, 0.5 part of medium chain triglyceride, 19 parts of trace elements, 27 parts of water-soluble vitamin, 5 parts of fat-soluble vitamin and 15 parts of flavoring agent;
the complex enzyme is a mixture of acidic protease APRS type FDG-2237 and endo-type protease FDY-2220;
the rest of the procedure was the same as in example 4.
Comparative analysis of efficacy
The following is a comparative analysis of the therapeutic effects of the biopharmaceutical prepared in this example 1 and Gangle capsule (patent publication No. CN 101574426B).
Ganle capsule (patent publication No. CN 101574426B) has the functions of strengthening body resistance, removing blood stasis and dredging collaterals, has a certain therapeutic effect on liver diseases, is one of the medicines clinically used for resisting hepatic fibrosis, and therefore, Ganle capsule (patent publication No. CN 101574426B) is selected as a control group. And observing, comparing and analyzing the immunological related indexes, nutritional immunological related indexes, hepatic fibrosis and other serological indexes of the patient under the condition of double blindness.
1.1 object. 150 observed subjects are patients with chronic hepatitis B, wherein 80 men and 70 women; age 20-65 years, mean age 38 years, 58 cases with jaundice, and 64 cases with splenomegaly.
1.2 grouping: 150 patients were randomized into 75 treatment groups, 40 men, 35 women, age 21-65 years, 49 patients with jaundice, and 32 patients with splenomegaly. The control group comprises 75 cases, 40 men and 35 women, aged 20-64 years, 47 cases with jaundice and 39 cases with splenomegaly. The sex, age distribution and disease conditions of the two groups are basically consistent, and the biological medicine (each capsule is 0.5 g) is taken by the treatment group 3 times a day, 3-6 capsules each time; the control group takes Ganle Capsule 3 times daily, 2-3 capsules each time. The symptomatic treatment is consistent, the treatment course is 3 months, and the follow-up visit is half a year.
1.3 Observation of items. (1) Immunological related indexes: natural Killer (NK) cells, and T cell subset CD4 +And CD8 +And (4) horizontal. (2) Nutritional and immunological related indices albumin, prealbumin, white globulin ratio (albumin/globulin): (3) the liver fibrosis index is as follows: serum Hyaluronic Acid (HA), Laminin (LN), and IV collagen (IV-C).
2. And (3) comparing the curative effects:
2.1 immunological-related index comparison: immunological related indices, Natural Killer (NK) cells, and T cell subset CD4 +/CD8 +The variation is shown in table 1.
As can be seen from Table 1, the first two groups treated NK levels and CD 4+//CD8+Comparison of values, all differences are not statistically significant (PAll > 0.05); control group NK levels and CD 4 after treatment+//CD8+Values, all increased compared to pretreatment, but differences were not statistically significant (1)PAll > 0.05), the increase after observation/group treatment was more pronounced than before treatment, and was statistically significant (PBoth < 0.05), and observed NK levels and CD 4 after group treatment+//CD8+The value is obviously higher than the NK level and CD 4 of the control group after treatment+//CD8+Value (PAll are less than 0.05). The results in Table 1 show that the biological medicine (medical food) provided by the invention used in the observation group can effectively improve the immunity index of the patient compared with the Ganle capsule (patent publication No. CN 101574426B) taken by the control group.
TABLE 1 comparison of immune status indexes before and after treatment in two groups (x±s)
Figure DEST_PATH_IMAGE001
2.2 related indexes of nutrition and immunology: albumin, prealbumin, white globule ratio (albumin/globulin) changes as shown in table 2.
TABLE 2 nutritional indices Albumin, Pre-Albumin, white globulin ratio (Albumin/globulin) Change
Figure 410824DEST_PATH_IMAGE002
As can be seen from Table 2, the albumin, prealbumin and white globulin ratios (albumin/globulin) of the observed group and the control group were not statistically different (P > 0.05) before treatment; after treatment, the albumin, prealbumin, white globulin ratio (albumin/globulin) of the control group was not significantly changed from that of the treatment (P > 0.05); the observed albumin, prealbumin and white globulin ratios (albumin/globulin) of the groups are significantly different (P is less than 0.05) compared with the albumin, prealbumin and white globulin ratios (albumin/globulin) before treatment, and are obviously better than the albumin, prealbumin and white globulin ratios (albumin/globulin) after the treatment of the control group, and the statistical differences (P is less than 0.05) among the groups are significant. The ratio of albumin to white spheres reflects the immunocompetence of the patient from the other side, and the albumin is increased in a reasonable range, which indicates that the immunocompetence of the organism is improved; the white ball ratio is inverted, which indicates that the immunity of the organism is low; prealbumin reflects the ability of the patient's liver to synthesize proteins from the other side.
The results show that the biological medicine (medical food) provided by the invention used by the observation group can effectively improve the levels of albumin and prealbumin of the patient, reduce the white-to-globulin ratio, reflect that the immunity of the organism is improved, improve the capability of the liver for synthesizing protein and map that the capability of the liver for synthesizing protein of the patient is recovered compared with the Ganle capsule (patent publication No. CN 101574426B) taken by the control group.
2.3 serum hepatic fibrosis index: serum Hyaluronic Acid (HA), serum Laminin (LN), serum type (iii) procollagen, serum type (IV-C) collagen changes before and after treatment: see table 3.
TABLE 3 serum HA, LN, IV-C, PC-III changes before and after treatment (X. + -. S)
Figure DEST_PATH_IMAGE003
Note: the numbers in parentheses in the table are exemplary numbers.
LN, HA, PC-III, IV-C also decreased in both groups after treatment, but more significantly in the treated group. The biological medicine provided by the invention can improve the fibrosis condition of liver fiber patients better than Ganle capsules (patent publication No. CN 101574426B), and clinical research and analysis prove that the biological medicine provided by the invention can improve four indexes of liver fiber (LN, HA, PC III and IV-C) caused by the biological medicine, is mainly benefited from the immune enhancement effect of a specific formula of the biological medicine, and is different from the effect of ground beetle and oligopeptide of degradation products thereof.
2.4 HBVM changes before and after treatment: the change conditions of the HBsAg system and the HBeAg system after treatment are shown in table 4, two continuously positive people of the HBsAg system and the HBeAg system are selected, and the influence of the medicine on the HBsAg system and the HBeAg system is observed. The results of 72 cases of the treatment groups and 70 cases of the control group were that 6 cases of the treatment groups and 1 case of the control group had the HbeAg index changed from positive to negative, and there was a significant difference between the two groups.
TABLE 4 systematic variation of HbsAg and HbeAg after treatment
Group of HBsAg turning negative anti-Hbs positive conversion HbeAg turning negative anti-Hbe transpositive
Observation group 6/71(7.0%) 0/36(0%) 31/71(43.7%) 15/71(23.9%)
Control group 1/70(1.4%) 0/30(0%) 10/70(14.3%) 7/70(10.0%)
Note: the data in the table are negative case number/treatment case number.
Clinical research and analysis prove that the improvement of HBVM indexes caused by the biological medicine provided by the invention is mainly benefited by the immune enhancement effect of the specific formula of the invention, and is different from the effect of immature bitter orange, ground beetle and oligopeptide degradation products thereof.
2.5 follow-up and curative effect: of the 56 cases in which ALT returned to normal in the treated group, 5 were elevated at follow-up; ALT in the control group recovered normal, 12 of 36 were elevated. In the HBVM treatment group, 2 of the HBsAg6 positive patients turn negative, 4 positive patients turn negative, 3 of the HBeAg30 negative patients turn positive, and 2 positive patients turn negative. The control group had negative after the HBsAg1 case turned negative, positive after 2 cases of HbeAg10 case turned negative, and positive after 1 case. The HBsAg and the HbeAg negative conversion rate treatment groups are 5.6% and 40.1% respectively until the follow-up visit is finished; the control group was 0% and 12.9%, respectively. And (3) judging the curative effect: the treatment group has 71 effective cases and 4 ineffective cases, and the effective rate is 94.7 percent; the control group has 51 effective cases and 24 ineffective cases, the effective rate is 68.0 percent, and the curative effect between the two groups is obviously different.

Claims (10)

1. A biological medicine for treating diseases of liver, gallbladder, spleen and pancreas is characterized in that the raw materials with the following weight portions are pulverized, part of the raw materials are extracted with effective substances, and part of the raw materials are specially treated or are subjected to enzyme digestion and then are prepared and the like to be prepared into solid beverage, or micropowder, powder, or freeze-dried powder, or granules, or suspension, or capsules and other suitable application forms; 0.4-30 parts of cordyceps sinensis or cordyceps sinensis powder, 10-16 parts of salvia miltiorrhiza, 20-40 parts of astragalus membranaceus, 10-20 parts of red paeony root, 1-50 parts of placenta, 0.5-50 parts of carrot, 0.1-39 parts of radix angelicae, 10-50 parts of liquorice, 9-50 parts of honeysuckle, 0.1-69 parts of radix achyranthis bidentatae and 0.1-29 parts of branched chain amino acid.
2. The biomedical for liver, gallbladder, spleen and pancreas diseases according to claim 1, wherein: the raw materials with the following parts by weight are ground, part of the raw materials are extracted with effective substances, part of the raw materials are specially treated, or the raw materials are subjected to enzyme digestion and then are prepared into solid beverage, or micropowder, powder, or freeze-dried powder, or granules, or suspension, or capsules and other suitable application forms; 0.5-19 parts of cordyceps sinensis or cordyceps sinensis powder, 11-15 parts of salvia miltiorrhiza, 25-35 parts of astragalus membranaceus, 12-18 parts of red paeony root, 9-39 parts of placenta, 1-39 parts of carrot, 1-29 parts of radix angelicae, 21-39 parts of liquorice, 16-39 parts of honeysuckle, 12-42 parts of radix achyranthis bidentatae and 12-22 parts of branched chain amino acid.
3. The method for preparing the biological medicine for the diseases of liver, gallbladder, spleen and pancreas as claimed in claims 1 to 2, which is characterized by comprising the following steps:
weighing the raw materials according to the weight part ratio of claim 1 or 2 for later use;
(1) extracting oil, putting the salvia miltiorrhiza, the red paeony root, the angelica dahurica and the honeysuckle into a distiller, adding 6 times of water by weight, soaking for 40-70 minutes, distilling for 2.5-3.5 hours, collecting distillate to obtain an oil-water mixture, separating the oil-water mixture to obtain volatile oil, clathrating the volatile oil by β -cyclodextrin with 10 times of weight, clathrating the volatile oil at the temperature of 60 +/-5 ℃ for 2 hours to obtain a clathrate compound, and carrying out liquid-solid separation on the residual materials after distillation to obtain medicine residues and medicine liquid;
(2) extracting fat, namely performing reflux extraction on the medicine dregs obtained in the step (1) and another bag of cleaned placenta for 2 times by using ethanol, adding 10 times of 60-85% ethanol by weight for the first time, performing reflux extraction for 1.5-2.5 hours, adding 8 times of 60-85% ethanol by weight into the filtered medicine dregs, performing reflux extraction for 1.5-2.5 hours, combining the two extracting solutions, and recovering the ethanol under a negative pressure state until the extracting solution has no alcohol smell to obtain liquid containing fat-soluble substances; carrying out liquid-solid separation on the residual materials after the reflux to obtain medicine residues, and recovering residual ethanol in the medicine residues under a negative pressure state until the medicine residues have no alcohol smell;
(3) decocting and extracting the medicine dregs in the step (2) and another bag of cleaned placenta, radix achyranthis bidentatae, carrot, liquorice and astragalus, mixing the medicine dregs with the other bag, decocting for 2 times, each time is 40-70 minutes, 8 times of water by weight is added for the first time, 6 times of water by weight is added for the second time, the medicine liquid obtained after the two times of decoction and filtration and the medicine liquid obtained in the step (1) are combined, and after the medicine liquid is concentrated to the relative density of 1.10-1.15 under negative pressure, the inclusion compound in the step (1) and the liquid containing the fat-soluble substances in the step (2) are added, and the mixture is uniformly mixed and dried into powder for later use;
(4) enzyme digestion and separation are carried out on the sorted placenta which is separately packed in the step (3) and decocted, the decocted placenta is fully dried and is micronized by an ultra-high speed pulverizer with 10000 revolutions per hour; taking cordyceps sinensis or cordyceps sinensis powder, micronizing the cordyceps sinensis or cordyceps sinensis powder by a high-speed crushing device at 10000 r/h, respectively slurrying the micronized placenta and the cordyceps sinensis or cordyceps sinensis powder micropowder, respectively carrying out enzyme digestion on the slurried placenta and the cordyceps sinensis or cordyceps sinensis powder micropowder by using a complex enzyme, and respectively taking placenta short peptide, cordyceps sinensis or cordyceps sinensis powder short peptide with the molecular weight of less than or equal to 3000Da obtained by enzyme digestion;
(5) and (3) uniformly mixing the placenta short peptide with the molecular weight of less than or equal to 3000Da obtained by enzyme digestion in the step (4), cordyceps sinensis or cordyceps sinensis powder short peptide with the dried powder obtained in the step (3), drying under negative pressure until the water content is less than or equal to 5%, and adding branched chain amino acid, or preparing into solid beverage, dried powder, micropowder, freeze-dried powder, granules, tablets, suspensions and other suitable application forms.
4. The method for preparing a biological medicine for liver, gallbladder, spleen and pancreas diseases according to claim 3, wherein the method comprises the following steps: the complex enzyme in the step (4) is a mixture of two or more than two of food, biological medicine grade acid protease APRL type FDY-2205, acid protease APRS type FDG-2237 and incision type protease FDY-2220.
5. The preparation method of the medical food and the biological medicine for the liver, gallbladder, spleen and pancreas diseases according to claim 3, which is characterized in that: when the drying method in the step (3) is spray drying, the drying pressure in the drying tower is 100-150Pa, the inlet temperature of the drying tower is 180 +/-5 ℃, and the outlet temperature is 80 +/-5 ℃; the temperature of the negative pressure concentration in the step (3) is 80 +/-5 ℃; the temperature of the negative pressure drying in the step (5) is 80 +/-5 ℃; in the step (4), the temperature of enzyme cutting is 0-69 ℃, the humidity is 39-99%, the illumination intensity is 0-300Lx, and the rotating speed of a centrifuge is 9-75 r/s.
6. A medical food for treating diseases of liver, gallbladder, spleen and pancreas is characterized in that the medical food is prepared by crushing the following raw materials in parts by weight, extracting active substances from parts by weight, specially treating parts by weight, or carrying out enzyme digestion, blending and other treatments, and then preparing into solid beverage, or micropowder, powder, or freeze-dried powder, or granules, or suspension, or capsules and other suitable application forms; 0.4-30 parts of cordyceps sinensis or cordyceps sinensis powder, 10-16 parts of salvia miltiorrhiza, 20-40 parts of astragalus membranaceus, 10-20 parts of red paeony root, 1-50 parts of placenta, 0.5-50 parts of carrot, 0.1-39 parts of angelica dahurica, 10-50 parts of liquorice, 9-50 parts of honeysuckle, 0.1-69 parts of radix achyranthis bidentatae, 0.1-29 parts of branched chain amino acid, 0.9-60 parts of maltodextrin, 0.5-30 parts of dietary fiber, 0.01-45 parts of medium-chain triglyceride, 0.1-19 parts of trace elements, 0.1-27 parts of water-soluble vitamin, 0.1-5 parts of fat-soluble vitamin and 0.9-15 parts of flavoring agent.
7. The medical food for liver, gallbladder, spleen and pancreas diseases according to claim 6, wherein: the raw materials with the following parts by weight are ground, part of the raw materials are extracted with effective substances, part of the raw materials are specially treated, or the raw materials are subjected to enzyme digestion and then are prepared into solid beverage, or micropowder, powder, or freeze-dried powder, or granules, or suspension, or capsules and other suitable application forms; 0.5-19 parts of cordyceps sinensis or cordyceps sinensis powder, 11-15 parts of salvia miltiorrhiza, 25-35 parts of astragalus membranaceus, 12-18 parts of radix paeoniae rubra, 9-39 parts of placenta, 1-39 parts of carrot, 1-29 parts of radix angelicae, 21-39 parts of liquorice, 16-39 parts of honeysuckle, 12-42 parts of radix achyranthis bidentatae, 12-22 parts of branched chain amino acid, 21-38 parts of maltodextrin, 18-25 parts of dietary fiber, 0.01-29 parts of medium chain triglyceride, 8-16 parts of trace elements, 9-20 parts of water-soluble vitamin, 2-3 parts of fat-soluble vitamin and 8-11 parts of flavoring agent.
8. The method for preparing the medical food for the diseases of liver, gallbladder, spleen and pancreas as claimed in claims 6 to 7 is characterized by comprising the following steps:
weighing the raw materials according to the weight part ratio of claim 6 or 7 for later use;
(1) extracting oil, putting the salvia miltiorrhiza, the red paeony root, the angelica dahurica and the honeysuckle into a distiller, adding 6 times of water by weight, soaking for 40-70 minutes, distilling for 2.5-3.5 hours, collecting distillate to obtain an oil-water mixture, separating the oil-water mixture to obtain volatile oil, clathrating the volatile oil by β -cyclodextrin with 10 times of weight, clathrating the volatile oil at the temperature of 60 +/-5 ℃ for 2 hours to obtain a clathrate compound, and carrying out liquid-solid separation on the residual materials after distillation to obtain medicine residues and medicine liquid;
(2) extracting fat, namely performing reflux extraction on the medicine dregs obtained in the step (1) and another bag of cleaned placenta for 2 times by using ethanol, adding 10 times of 60-85% ethanol by weight for the first time, performing reflux extraction for 1.5-2.5 hours, adding 8 times of 60-85% ethanol by weight into the filtered medicine dregs, performing reflux extraction for 1.5-2.5 hours, combining the two extracting solutions, and recovering the ethanol under a negative pressure state until the extracting solution has no alcohol smell to obtain liquid containing fat-soluble substances; carrying out liquid-solid separation on the residual materials after the reflux to obtain medicine residues, and recovering residual ethanol in the medicine residues under a negative pressure state until the medicine residues have no alcohol smell;
(3) decocting and extracting the medicine dregs in the step (2) and another bag of cleaned placenta, radix achyranthis bidentatae, carrot, liquorice and astragalus, mixing the medicine dregs with the other bag, decocting for 2 times, each time is 40-70 minutes, 8 times of water by weight is added for the first time, 6 times of water by weight is added for the second time, the medicine liquid obtained after the two times of decoction and filtration and the medicine liquid obtained in the step (1) are combined, and after the medicine liquid is concentrated to the relative density of 1.10-1.15 under negative pressure, the inclusion compound in the step (1) and the liquid containing the fat-soluble substances in the step (2) are added, and the mixture is uniformly mixed and dried into powder for later use;
(4) enzyme digestion and separation are carried out on the sorted placenta which is separately packed in the step (3) and decocted, the decocted placenta is fully dried and is micronized by an ultra-high speed pulverizer with 10000 revolutions per hour; taking cordyceps sinensis or cordyceps sinensis powder, micronizing the cordyceps sinensis or cordyceps sinensis powder by a high-speed crushing device at 10000 r/h, respectively slurrying the micronized placenta and the cordyceps sinensis or cordyceps sinensis powder micropowder, respectively carrying out enzyme digestion on the slurried placenta and the cordyceps sinensis or cordyceps sinensis powder micropowder by using a complex enzyme, and respectively taking placenta short peptide, cordyceps sinensis or cordyceps sinensis powder short peptide with the molecular weight of less than or equal to 3000Da obtained by enzyme digestion;
(5) and (3) uniformly mixing the placenta short peptide with the molecular weight of less than or equal to 3000Da obtained by enzyme digestion in the step (4), cordyceps sinensis or cordyceps sinensis powder short peptide with the dried powder obtained in the step (3), drying under negative pressure until the water content is less than or equal to 5%, adding branched chain amino acid, maltodextrin, dietary fiber, medium chain triglyceride, trace elements, water-soluble vitamins, fat-soluble vitamins and flavoring agents, or preparing the mixture into solid beverage, dried powder, or micropowder, or freeze-dried powder, or granules, or preparing the mixture into tablets, suspensions and other suitable application forms.
9. The method for preparing a medical food for liver, gallbladder, spleen and pancreas diseases according to claim 8, wherein the method comprises the following steps: the complex enzyme in the step (4) is a mixture of two or more than two of food, biological medicine grade acid protease APRL type FDY-2205, acid protease APRS type FDG-2237 and incision type protease FDY-2220.
10. The method for preparing a medical food for liver, gallbladder, spleen and pancreas diseases according to claim 8, wherein the method comprises the following steps: when the drying method in the step (3) is spray drying, the drying pressure in the drying tower is 100-150Pa, the inlet temperature of the drying tower is 180 +/-5 ℃, and the outlet temperature is 80 +/-5 ℃; the temperature of the negative pressure concentration in the step (3) is 80 +/-5 ℃; the temperature of the negative pressure drying in the step (5) is 80 +/-5 ℃; in the step (4), the temperature of enzyme cutting is 0-69 ℃, the humidity is 39-99%, the illumination intensity is 0-300Lx, and the rotating speed of a centrifuge is 9-75 r/s.
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CN101574426A (en) * 2009-03-13 2009-11-11 淮安市楚州医院 Chinese patent medicament for treating liver diseases and method for preparing same

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101574426A (en) * 2009-03-13 2009-11-11 淮安市楚州医院 Chinese patent medicament for treating liver diseases and method for preparing same

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