WO2022242128A1 - 一种感染性疾病康复用的中药组合物及其用途 - Google Patents
一种感染性疾病康复用的中药组合物及其用途 Download PDFInfo
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Definitions
- the invention belongs to the field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition and traditional Chinese medicine suitable for effectively preventing, treating or alleviating sequelae or complications of infectious diseases or promoting the recovery of damaged tissues, organs or systems caused by infectious diseases preparation.
- the present invention also relates to the method for preparing the Chinese medicine composition and Chinese medicine preparation of the present invention, and the Chinese medicine composition and Chinese medicine preparation are used for preventing, treating or alleviating the sequelae or complications of infectious diseases or promoting damage to tissues caused by infectious diseases, Use for restoration of function of an organ or system.
- the new crown pneumonia epidemic is the most serious infectious disease pandemic that has occurred in the world in a century.
- my country has completely and effectively controlled the new crown pneumonia epidemic and achieved major strategic results in the fight against the new crown pneumonia epidemic
- the new crown pneumonia epidemic is still raging around the world.
- the nucleic acid of the virus test turned negative twice, and the lung images tended to improve before they could be discharged from the hospital.
- the patient was only non-infectious and not clinically cured.
- the new type of coronavirus pneumonia is a syndrome of dampness and toxin stagnation in the lungs.
- One object of the present invention is to provide a Chinese medicine composition and Chinese medicine preparation suitable for effectively preventing, treating or alleviating the sequelae or complications of infectious diseases or promoting the functional recovery of damaged tissues, organs or systems caused by infectious diseases
- the traditional Chinese medicine composition and traditional Chinese medicine preparation comprise Chinese medicinal materials or active extracts thereof that are effective in preventing, treating or alleviating sequelae or complications of infectious diseases or promoting functional recovery of damaged tissues, organs or systems caused by infectious diseases.
- Another object of the present invention is to provide a method for effectively preventing, treating or alleviating sequelae or complications of infectious diseases or promoting functional recovery of damaged tissues, organs or systems caused by infectious diseases by using traditional Chinese medicine compositions or preparations , or alternatively provide the use of the traditional Chinese medicine composition in the preparation of drugs for effectively preventing, treating or alleviating the sequelae or complications of infectious diseases or promoting the functional recovery of damaged tissues, organs or systems caused by infectious diseases.
- the inventors of the present application have long been concerned about the recovery problems of patients with some major diseases including infectious diseases, and have been devoting themselves to researching and solving these problems.
- the inventor According to the theory of traditional Chinese medicine, on the basis of the ancient proven prescriptions of traditional Chinese medicine, the inventor has researched and determined a Chinese medicine prescription, and it has been proved through experiments that this prescription can effectively prevent, treat or alleviate the sequelae or complications of infectious diseases or promote the treatment of infectious diseases. Impairment of recovery of function of a tissue, organ or system caused by an infectious disease. Based on these findings, the present inventors have completed the present invention.
- the present invention provides a traditional Chinese medicine composition and preparation suitable for effectively preventing, treating or alleviating sequelae or complications of infectious diseases or promoting functional recovery of damaged tissues, organs or systems caused by infectious diseases.
- the Chinese medicine composition of the present invention is made up of any form of the following Chinese medicinal materials:
- the Chinese medicine composition of the present invention can be made up of the mixture of the original medicinal material powder or the powder of the original medicinal material mixture of the following Chinese medicinal materials:
- the Chinese medicine composition of the present invention can also be made up of the respective formula granules of the following Chinese medicinal materials:
- the Chinese medicine composition of the present invention can also be made up of the solvent extract of following Chinese medicinal material mixture:
- the traditional Chinese medicine preparation of the present invention contains the traditional Chinese medicine composition of the present invention, and may also contain pharmaceutically acceptable auxiliary materials.
- the traditional Chinese medicine preparation of the present invention comprises any form of the following Chinese medicinal materials or their solvent extracts:
- the Chinese medicine preparation of the present invention may be an oral solution comprising the following Chinese medicinal materials or their solvent extracts:
- the Chinese medicine preparation of the present invention can be a granule comprising the following Chinese medicinal materials or their solvent extracts:
- the Chinese medicine preparation of the present invention can be a pill comprising the following Chinese medicinal materials or their solvent extracts:
- the Chinese medicinal preparation of the present invention can be a capsule comprising the following Chinese medicinal materials or their solvent extracts:
- the Chinese medicine preparation of the present invention can be a tablet comprising the following Chinese medicinal materials or their solvent extracts:
- the Chinese medicine preparation of the present invention may be a syrup comprising the following Chinese medicinal materials or their solvent extracts:
- the Chinese medicine preparation of the present invention may be an ointment comprising the following Chinese medicinal materials or their solvent extracts:
- the present invention provides a traditional Chinese medicine composition according to the present invention, which is suitable for effectively preventing, treating or alleviating the sequelae or complications of infectious diseases or promoting the function of damaged tissues, organs or systems caused by infectious diseases. Use in recovery medicines.
- the present invention provides a method for preventing, treating or alleviating the sequelae or complications of infectious diseases or promoting functional recovery of damaged tissues, organs or systems caused by infectious diseases, the method comprising administering to patients in need An effective dose of the traditional Chinese medicine composition or traditional Chinese medicine preparation according to the present invention.
- the present invention provides a traditional Chinese medicine composition or traditional Chinese medicine preparation as described in this application, which is used for preventing, treating or alleviating sequelae or complications of infectious diseases or promoting damage to tissues, organs or organs caused by infectious diseases. The function of the system is restored.
- the Chinese medicine composition and Chinese medicine preparation of the present invention can nourish qi and nourish yin, regulate the spleen and stomach, clear away deficiency heat, and relieve irritability, and are suitable for preventing, treating or relieving sequelae or complications of infectious diseases or promoting damage to tissues caused by infectious diseases , the restoration of function of an organ or system.
- the traditional Chinese medicine composition and traditional Chinese medicine preparation of the present invention have significant beneficial effects such as anti-inflammation, anti-oxidation, enhancement of body immunity and organ protection. Therefore, it is expected that the traditional Chinese medicine composition and traditional Chinese medicine preparation according to the present invention can be used to prevent, treat or alleviate the sequelae or complications of infectious diseases or promote the functional recovery of damaged tissues, organs or systems caused by infectious diseases. Sequelae or complications include, but are not limited to, acute abdomen after acute infection; sepsis; qi deficiency and profuse sweating after surgery; and physical weakness, fatigue, fatigue, etc. after infection by pathogenic microorganisms.
- ginseng used in the present invention refers to the dried root and rhizome of Panax ginseng C.A.Mey., a plant of Araliaceae.
- Ophiopogon japonicus used in the present invention refers to the dry tuber root of Ophiopogon japonicus (L.f) Ker-Gawl.
- Schisandra used in the present invention refers to the dry ripe fruit of Schisandra chinensis (Turcz.) Baill. Known as “Northern Schisandra”.
- Poria cocos used in the present invention refers to the dried sclerotia of Poria cocos (Schw.) Wolf, a fungus of Polyporaceae.
- Quading Pinellia used in the present invention refers to the product processed and processed according to the following method: take Pinellia clean, separate it in size, soak it in 8% alum solution until there is no dry core in it, and it feels slightly numb in the mouth , take out, wash, cut into thick slices, and dry.
- Pinellia refers to the dry tuber of Pinellia ternata (Thunb.) Breit.
- scrophulariae used in the present invention refers to the dry root of Scrophularia ningpoensis Hemsl.
- the term "stir-fried Atractylodes Rhizome” used in the present invention is a product obtained by processing Atractylodes Rhizome slices according to the bran-fried method.
- the term “Atractylodes” refers to the dried rhizome of Atractylodes lancea (Thunb.) DC. or Atractylodes chinensis (DC.) Koidz. of Compositae.
- tangerine peel used in the present invention is the dry mature pericarp of Rutaceae plant Citrus reticulata Blanco and its cultivars.
- licorice used in the present invention refers to the dried roots and rhizomes of Glycyrrhiza uralensis Fisch., Glycyrrhiza inflata Bat. or Glycyrrhiza glabra L. of the leguminous plant Glycyrrhiza uralensis Fisch.
- Bupleurum used in the present invention refers to the dried root of Bupleurum chinense DC. or Bupleurum scorzonerifolium Willd. of Umbelliferae.
- cimicifuga used in the present invention is the dry rhizome of Cimicifuga heracleifolia Kom., Cimicifuga dahurica (Turcz.) Maxim. or Cimicifuga foetida L. of the Ranunculaceae plant.
- coix seed used in the present invention refers to the dry mature seed kernel of the grass Coixlacryma-jobi L.var.ma-yuen (Roman.) Stapf.
- scutellaria baicalensis used in the present invention refers to the dry root of Scutellaria baicalensis Georgi, a plant of the Labiatae family.
- verbena used in the present invention refers to the dry aerial part of Verbena officinalis L., a plant of the family Verbenaceae.
- root used in the present invention refers to the fresh or dry rhizome of Phragmites communis Trin.
- leaf of light bamboo used in the present invention refers to the dry stem and leaf of the leaf of grass Lophatherum gracile Brongn.
- raw medicinal material powder used in the present invention refers to Chinese herbal medicine powder with all components and no additives processed from decoction pieces of Chinese herbal medicines by physical methods, such as coarse pulverization, fine pulverization, micronization and physical wall-breaking pulverization.
- prescription granule used in the present invention refers to a single-flavored Chinese medicine product that is refined by extracting, concentrating, drying and other processes in the way of decocting traditional Chinese medicine decoctions by adopting modern science and technology.
- the product maintains the nature, taste and efficacy of traditional Chinese medicine decoction pieces, and the quality is stable and reliable. It is used in the deployment of clinical prescriptions of traditional Chinese medicine, adapts to the needs of syndrome differentiation and treatment, and changes in prescriptions.
- solvent extract used in the present invention refers to the extraction of any form of the Chinese herbal medicine (including Chinese herbal medicine decoction pieces, Chinese herbal medicine powder, such as Chinese herbal medicine micronized powder) with a suitable pharmaceutically acceptable solvent such as water or alcoholic aqueous solution
- a suitable pharmaceutically acceptable solvent such as water or alcoholic aqueous solution
- the obtained substances including specific active ingredients and mixtures containing active ingredients, are suitable for the recovery of patients with major diseases such as new crown pneumonia convalescence, effectively preventing, treating or relieving sequelae or complications of infectious diseases or promoting the recovery of damage caused by infectious diseases. Restoration of function of a tissue, organ or system caused by a disease.
- Forms of solvent extracts include, but are not limited to, solids, semi-solids, solutions, suspensions, concentrates, pastes, and powders.
- Water suitable for extracting Chinese medicinal materials to obtain extracts in the present invention includes various waters that can be used to prepare active extracts of traditional Chinese medicines, such as medicinal water, such as distilled water and deionized
- alcohol aqueous solution refers to an alcohol-containing aqueous solution of suitable concentration (such as low concentration, especially 10-50% v/v), suitable alcohols include various alcohols, preferably ethanol. Under certain conditions, it is also possible to use alcoholic aqueous solutions with a concentration higher than 50% v/v.
- patient and “subject” used in the present invention can be used interchangeably, and refer to a mammal suffering from a disease such as COVID-19, especially a human.
- pharmaceutically acceptable adjuvant used in the present invention refers to any adjuvant commonly used in the field of pharmaceutical preparations, as long as the adjuvant does not have adverse reactions or effects on the expected quality and curative effect of the traditional Chinese medicine composition of the present invention.
- unit dosage form means physically discrete units suitable as unitary dosages for human subjects and other mammals, each unit containing a predetermined quantity of the present invention calculated to produce the desired therapeutic effect.
- traditional Chinese medicine compositions and traditional Chinese medicine preparations suitable for effectively preventing, treating or alleviating sequelae or complications of infectious diseases or promoting functional recovery of damaged tissues, organs or systems caused by infectious diseases.
- the traditional Chinese medicine composition of the present invention consists of or is made from any form of Chinese medicinal materials in the following parts by weight:
- the traditional Chinese medicine composition of the present invention is made up of the following Chinese medicinal materials in any form or made from these Chinese medicinal materials in parts by weight:
- the traditional Chinese medicine composition of the present invention is a mixture of the powders of the original Chinese medicinal materials or a powder of the mixture of the original medicinal materials in the following parts by weight:
- the traditional Chinese medicine composition of the present invention is a mixture of the powders of the original Chinese medicinal materials or a powder of the mixture of the original medicinal materials in the following parts by weight:
- the traditional Chinese medicine composition of the present invention consists of the following formula granules of Chinese medicinal materials in parts by weight:
- the traditional Chinese medicine composition of the present invention is made up of the respective formula granules of the following Chinese medicinal materials in parts by weight:
- the traditional Chinese medicine composition of the present invention is any form of solvent extract of the following Chinese medicinal material mixture in parts by weight:
- the solvent mentioned therein refers to any applicable solvent that can be used to extract the active ingredients of traditional Chinese medicine or prepare traditional Chinese medicine preparations as defined in this description, and the form of the extract can be solution, granule and freeze-dried powder.
- the traditional Chinese medicine composition of the present invention is any form of solvent extract of the following Chinese medicinal material mixture in parts by weight:
- the solvent mentioned therein refers to any applicable solvent that can be used to extract the active ingredients of traditional Chinese medicine or prepare traditional Chinese medicine preparations as defined in this description, and the form of the extract can be solution, granule and freeze-dried powder.
- the Chinese medicinal composition of the present invention can also be a mixture of extracts extracted separately from Chinese medicinal materials in the following parts by weight:
- the form of the extract can be solution, granule, freeze-dried powder and the like.
- the Chinese medicine composition of the present invention may also be a mixture of extracts extracted separately from Chinese medicinal materials in the following parts by weight:
- the form of the extract can be solution, granule, freeze-dried powder and the like.
- the Chinese medicinal composition of the present invention is the water extract of the following Chinese medicinal material mixture in parts by weight:
- the Chinese medicine composition of the present invention is the water extract of the following Chinese medicinal material mixture in parts by weight:
- the traditional Chinese medicine composition of the present invention is the alcoholic aqueous extract of the following Chinese medicinal material mixture by weight:
- the alcohol aqueous solution described therein includes as defined in this specification.
- the traditional Chinese medicine composition of the present invention is the alcoholic aqueous extract of the following Chinese medicinal material mixture by weight:
- the alcohol aqueous solution described therein includes as defined in this specification.
- the traditional Chinese medicine composition of the present invention is the alcoholic aqueous extract of the following Chinese medicinal material mixture by weight:
- the alcohol aqueous solution described therein includes as defined in this specification.
- the Chinese medicine composition of the present invention is the alcoholic aqueous solution extract of the Chinese medicinal material mixture of following parts by weight:
- the alcohol aqueous solution described therein includes as defined in this specification.
- the traditional Chinese medicine composition of the present invention can be made into any clinically applicable formulation.
- the traditional Chinese medicine preparation of the present invention may also contain pharmaceutically acceptable auxiliary materials.
- the traditional Chinese medicine preparation of the present invention comprises any form of Chinese medicinal materials in the following parts by weight, or extracts obtained by extracting them separately or in combination:
- It may additionally contain or not contain pharmaceutically acceptable excipients.
- the traditional Chinese medicine preparation of the present invention comprises any form of Chinese medicinal materials in the following parts by weight, or the extracts extracted separately or combined:
- It may additionally contain or not contain pharmaceutically acceptable excipients.
- the traditional Chinese medicine preparation according to the present invention can be formulated into appropriate dosage forms according to clinical needs, such as solutions, decoctions, granules, powders, granules, pills, tablets, ointments, capsules or syrups.
- the traditional Chinese medicine preparation of the present invention is an oral solution in unit dose form made of the following Chinese medicinal materials in parts by weight:
- the traditional Chinese medicine preparation of the present invention is an oral solution in unit dose form made of the following Chinese medicinal materials in parts by weight:
- the traditional Chinese medicine preparation of the present invention is a decoction in unit dose form made of the following Chinese medicinal materials in parts by weight:
- the traditional Chinese medicine preparation of the present invention is a decoction in the form of a unit dose made of the following Chinese medicinal materials in parts by weight:
- the traditional Chinese medicine preparation of the present invention is a granule in unit dosage form made of the following Chinese medicinal materials in parts by weight:
- the traditional Chinese medicine preparation of the present invention is a granule, which comprises
- Acceptable excipients in pharmaceutical granules for example, lactose, mannitol or a mixture thereof, preferably a 2:1 mixture of lactose:mannitol.
- the traditional Chinese medicine preparation of the present invention is a granule, which comprises
- the method described therein comprises the steps of:
- Acceptable excipients in pharmaceutical granules for example, lactose, mannitol or a mixture thereof, preferably a 2:1 mixture of lactose:mannitol.
- the traditional Chinese medicine preparation of the present invention is a granule in the form of a unit dosage made of the following Chinese medicinal materials in parts by weight:
- the traditional Chinese medicine preparation of the present invention is a granule, which comprises
- Acceptable excipients in pharmaceutical granules for example, lactose, mannitol or a mixture thereof, preferably a 2:1 mixture of lactose:mannitol.
- the traditional Chinese medicine preparation of the present invention is a granule, which comprises
- the method described therein comprises the steps of:
- Acceptable excipients in pharmaceutical granules for example, lactose, mannitol or a mixture thereof, preferably a 2:1 mixture of lactose:mannitol.
- the Chinese medicine preparation of the present invention is a powder in the form of a unit dose made of the following Chinese medicinal materials in parts by weight:
- the traditional Chinese medicine preparation of the present invention is a powder in the form of a unit dosage made of the following Chinese medicinal materials in parts by weight:
- the traditional Chinese medicine preparation of the present invention is a capsule made of the following Chinese medicinal material mixture in parts by weight:
- the traditional Chinese medicine preparation of the present invention is a capsule made of the following Chinese medicinal material mixture by weight:
- the traditional Chinese medicine preparation of the present invention is a pill made of the following Chinese medicinal material mixture in parts by weight:
- the traditional Chinese medicine preparation of the present invention is a pill made of the following Chinese medicinal material mixture in parts by weight:
- the traditional Chinese medicine preparation of the present invention is an ointment made of the following Chinese medicinal material mixture in parts by weight:
- the traditional Chinese medicine preparation of the present invention is an ointment made of the following Chinese medicinal material mixture in parts by weight:
- the traditional Chinese medicine preparation according to the present invention may also contain pharmaceutically acceptable auxiliary materials in addition to the traditional Chinese medicine composition of the present invention.
- the pharmaceutically acceptable excipients that can be used in the traditional Chinese medicine composition of the present invention include any excipients commonly used in traditional Chinese medicine preparations, as long as the excipients do not adversely affect the quality, performance and therapeutic effect of the traditional Chinese medicine composition of the present invention.
- Commonly used excipients in traditional Chinese medicine preparations include diluents, carriers, fillers, binders, wetting agents, disintegrants, absorption promoters, surfactants, adsorption carriers, and lubricants.
- Commonly used diluents mainly include sucrose, dextrin, starch, lactose, mannitol, xylitol, bifidosaccharide, etc.
- Commonly used wetting agents mainly include water, ethanol of different concentrations, etc.; commonly used adhesives include polymer adhesives, and there are many types, such as ethyl cellulose, polyvinylpyrrolidone, sodium carboxymethyl cellulose, polyvinyl Ethylene glycol, sodium alginate, etc.
- Commonly used disintegrants include microcrystalline cellulose, sodium carboxymethyl starch, etc.
- the traditional Chinese medicine preparation of the present invention may also contain suitable additives.
- additives are known in the art, such as emulsifiers, fragrances, solubilizers, anticaking agents, defoamers, binders, buffers, pH regulators, propellants, chelating agents, and preservatives.
- the Chinese medicinal materials can be soaked for a period of time, or the Chinese medicinal materials can be physically processed to facilitate the extraction of active substances.
- the corresponding Chinese herbal medicines can be used alone or their mixtures, through conventional pulverization, leaching and separation methods in the field, such as maceration, diafiltration, liquid-liquid extraction , water extraction and alcohol precipitation, alcohol extraction and water precipitation and dialysis and other methods to prepare the active Chinese medicine extract and Chinese medicine preparation applicable in the present invention. It is also possible to purchase one or more active extracts of traditional Chinese medicines used in the present invention through commercial channels, and then mix them with the extracts of other traditional Chinese medicines to obtain the active extracts of traditional Chinese medicines of the present invention.
- the Chinese medicine compositions and Chinese medicine preparations of these variations are all within the scope of the present invention.
- the Chinese medicine composition and Chinese medicine preparation of the present invention can nourish qi and nourish yin, regulate the spleen and stomach, clear away deficiency heat, and relieve irritability, and are suitable for preventing, treating or relieving sequelae or complications of infectious diseases or promoting damage to tissues caused by infectious diseases , the restoration of function of an organ or system.
- the traditional Chinese medicine composition and traditional Chinese medicine preparation of the present invention have significant beneficial effects such as anti-inflammation, anti-oxidation, enhancement of body immunity and organ protection. Therefore, the traditional Chinese medicine composition and traditional Chinese medicine preparation according to the present invention can be used for preventing, treating or alleviating the sequelae or complications of infectious diseases or promoting the functional recovery of damaged tissues, organs or systems caused by infectious diseases.
- complications include but are not limited to acute abdomen after acute infection by pathogenic microorganisms; sepsis; Qi deficiency and profuse sweating after surgery; and physical weakness, fatigue, and fatigue after pathogenic microorganism infection.
- the traditional Chinese medicine composition or traditional Chinese medicine preparation according to the present invention is provided for preventing, treating or alleviating the sequelae or complications of infectious diseases or promoting damage to tissues, organs or systems caused by infectious diseases The purpose of functional recovery.
- the traditional Chinese medicine composition according to the present invention is provided in the preparation of drugs suitable for preventing, treating or alleviating the sequelae or complications of infectious diseases or promoting the functional recovery of damaged tissues, organs or systems caused by infectious diseases use in .
- a Chinese medicine composition or Chinese medicine preparation of the present invention is provided to effectively prevent, treat or alleviate the sequelae or complications of infectious diseases or promote the function of damaged tissues, organs or systems caused by infectious diseases.
- a recovery method which comprises administering an effective amount of the traditional Chinese medicine composition or traditional Chinese medicine preparation according to the present invention to a patient in need.
- the traditional Chinese medicine composition according to the present invention is suitable for preventing, treating or alleviating the sequelae or complications of new coronary pneumonia or promoting the function of the damaged tissues, organs or systems caused by new coronary pneumonia in patients with new coronary pneumonia. Use in recovery medicines.
- a method of using the Chinese medicine composition or Chinese medicine preparation of the present invention to prevent, treat or alleviate the sequelae or complications of new coronary pneumonia or to promote damage to the tissues, organs or systems caused by new coronary pneumonia in patients with new coronary pneumonia comprising administering an effective amount of the traditional Chinese medicine composition or traditional Chinese medicine preparation according to the present invention to a patient with new coronary pneumonia in need.
- the use of the traditional Chinese medicine composition according to the present invention in the preparation of medicines suitable for preventing, treating or alleviating the sequelae or complications of new coronary pneumonia is provided, wherein the sequelae or complications include but are not limited to upset Symptoms include laxity, dry cough with little phlegm, bad throat, shortness of breath after movement, fatigue, fullness in the chest and abdomen, anorexia and soft stools, heaviness in limbs, and pale tongue with little fluid.
- a method of using the Chinese medicine composition or Chinese medicine preparation of the present invention to prevent, treat or alleviate the sequelae or complications of new coronary pneumonia comprising administering an effective amount of the Chinese medicine according to the present invention to a patient in need
- Traditional Chinese medicine composition or traditional Chinese medicine preparation wherein the sequelae or complications include but not limited to upset, dry cough with little phlegm, bad throat, shortness of breath after movement, fatigue, fullness in the chest and abdomen, anorexia and soft stool, heaviness of the limbs and Symptoms such as pale tongue and less fluid.
- the traditional Chinese medicine composition according to the present invention in the preparation of medicines suitable for preventing, treating or alleviating sequelae or complications of infectious diseases, wherein said sequelae or complications include but are not limited to Acute abdomen after acute infection by pathogenic microorganisms; sepsis; qi deficiency and profuse sweating after surgery; and physical weakness, fatigue, and fatigue after infection by pathogenic microorganisms.
- a method for preventing, treating or alleviating sequelae or complications of infectious diseases using the traditional Chinese medicine composition or Chinese medicine preparation of the present invention comprising administering an effective amount of the traditional Chinese medicine according to the present invention to a patient in need
- the traditional Chinese medicine composition or traditional Chinese medicine preparation, wherein the sequelae or complications include but not limited to acute abdomen after acute infection by pathogenic microorganisms; sepsis; Qi deficiency and profuse sweating after surgery; and physical weakness after pathogenic microorganism infection, Burnout, fatigue, etc.
- the use of the traditional Chinese medicine composition according to the present invention as an anti-oxidative and/or anti-inflammatory drug is provided, or the use of the traditional Chinese medicinal composition according to the present invention in the preparation of anti-oxidative and/or anti-inflammatory drugs is provided. Uses in medicine.
- the traditional Chinese medicine composition according to the present invention in the preparation of a drug suitable for promoting the functional recovery of damaged tissues, organs or systems caused by infectious diseases, wherein the functions include respiratory related functions, functions related to bodily activities, and functions related to mental activities.
- the traditional Chinese medicine composition and traditional Chinese medicine preparation of the present invention can be administered in any suitable manner and any suitable form commonly used in the art.
- the traditional Chinese medicine composition and traditional Chinese medicine preparation of the present invention can be administered via a mode selected from: oral administration, spray inhalation, nasal cavity administration, and parenteral administration such as intravenous and intramuscular administration, among which oral administration, intramuscular injection or intravenous administration are preferred. Intravenous injection.
- the traditional Chinese medicine composition of the present invention can be made into a unit dosage form for patients to take.
- the dosage form for administration may be a liquid dosage form or a solid dosage form.
- the liquid dosage form can be solution type, colloid type, emulsion dosage form or suspension dosage form etc.
- Solid dosage forms may be, for example, tablets, powders, suppositories, granules, or capsules. Other dosage forms include aerosols, patches or liniments, and the like.
- the traditional Chinese medicine composition of the present invention can be used orally, for example, twice a day, 5-30 grams each time, such as 10-20 grams, preferably 10 grams of the granules of the present invention or other forms of the present invention
- Traditional Chinese medicine composition and traditional Chinese medicine preparation The specific dosage depends on the body weight of the patient to be treated, the nature and severity of the disease, the way of drug administration, the cycle or time interval of administration and other factors. For some patients with special circumstances, the specific administration should follow the doctor's advice.
- the traditional Chinese medicine composition and traditional Chinese medicine preparation of the present invention can be used in combination with other medicines and techniques known in the art that can be used for the treatment of COVID-19 recovery period.
- Those skilled in the art can think of and determine the medicines and techniques suitable for the treatment of new coronary pneumonia convalescence that can be used in combination with the traditional Chinese medicine composition and traditional Chinese medicine preparation of the present invention and will not produce adverse effects.
- the Chinese medicine composition and Chinese medicine preparation of the present invention can be used in combination with appropriate techniques of traditional Chinese medicine, wherein said appropriate techniques of traditional Chinese medicine include moxibustion therapy, meridian massage, scraping therapy, cupping and acupuncture.
- the Chinese medicinal materials used in the following examples are all purchased from the market and qualified through identification, the experimental reagents and experimental instruments used are commonly used experimental reagents and experimental instruments in this area, and the assay methods used are commonly used in this area methods, unless otherwise specified.
- Embodiment 1 the preparation of Chinese medicine composition (granule) of the present invention
- the above sixteen flavors are decocted twice, the first time is 60 minutes, the second time is 40 minutes, the amount of water added is 8 times and 6 times respectively, filtered, and the filtrate is concentrated to a relative density of 1.02-1.10 (60°C).
- Spray drying add appropriate amount of auxiliary materials (lactose: mannitol (2:1)), mix well, dry press granules, divide into two bags, and obtain the traditional Chinese medicine composition granules of the present invention.
- the Chinese medicine composition (granule) of the present invention prepared according to the method for embodiment 1.
- tBHQ (Tertiary butylhydroquinone, tertiary butylhydroquinone), MedChemExpress Company. Batch number: HY-100489, within the validity period. Specification: 500mg, usage and dosage: refer to clinical usage, and prepare as 100mM mother solution.
- 293T cells were purchased from ATCC cell bank.
- Competent cells DH5a were purchased from Tiangen Biochemical Technology Co., Ltd.
- the traditional Chinese medicine composition of the present invention 0.01 ⁇ g/mL, 0.1 ⁇ g/mL, 1 ⁇ g/mL, 10 ⁇ g/mL, 100 ⁇ g/mL.
- Preparation of medicinal solution Before the test, the granules were prepared into a medicinal solution with a concentration of 100 mg/mL with distilled water, and diluted to the experimental concentration when used.
- the triangular flask After the triangular flask is sterilized by high temperature and high pressure, add 2.5g dry powder of LB liquid medium into the bottle, and add 100mL sterilized ultrapure water to dissolve it completely. After the bottle mouth is pasted with a filter membrane, it is sterilized under high temperature and high pressure . When it is cooled to about 55°C, add 100 ⁇ L of 100 mg/mL ampicillin and mix well. The cells are cultured in DMEM medium containing 10% FBS, and subcultured when the cells in the culture flask grow to 80-90%.
- Cytotoxicity detection is divided into blank control group and 0.01 ⁇ g/mL, 0.1 ⁇ g/mL, 1 ⁇ g/mL, 10 ⁇ g/mL, 100 ⁇ g/mL 5 concentration groups of traditional Chinese medicine composition of the present invention;
- Antioxidant activity detection is divided into blank control group, positive drug tBHQ group and 0.01 ⁇ g/mL, 0.1 ⁇ g/mL, 1 ⁇ g/mL, 10 ⁇ g/mL, 100 ⁇ g/mL 5 concentration groups of traditional Chinese medicine composition of the present invention;
- Anti-inflammatory effect detection is divided into blank control group, model group, positive drug dexamethasone group and 0.01 ⁇ g/mL, 0.1 ⁇ g/mL, 1 ⁇ g/mL, 10 ⁇ g/mL, 100 ⁇ g/mL 5 concentration groups of traditional Chinese medicine composition of the present invention .
- Cell number/mL (cell number in four grid areas)/4 ⁇ 10 4 ⁇ dilution factor
- CCK-8 and LDH kits were used to investigate the influence of different concentrations of the traditional Chinese medicine composition of the present invention on the viability of 293T cells.
- the original 96-well plate was washed once with PBS, and 100 ⁇ L of diluted 1 ⁇ CCK-8 working solution was added to each well, and incubated at 37°C for 1 h. Set up a microplate reader to measure the absorbance (OD value) at 450 nm.
- the cells transfected with the ARE luciferase reporter plasmid pGL4.37 were added with tBHQ (10 ⁇ M) and sample solutions of each group of Chinese medicine composition of the present invention at a safe concentration, and a Control group was set up, and cultured for 6 hours; transfected with NF -The cells of the ⁇ B luciferase reporter plasmid pGL4.32 were added with fully cultured and diluted dexamethasone (10 ⁇ M) containing TNF- ⁇ (10ng/mL), each group of sample solutions of the Chinese medicine composition of the present invention at a safe concentration, And set Control group, Model group (10ng/mL TNF- ⁇ ), culture 6h.
- Table 1 Effects of different concentrations of traditional Chinese medicine composition of the present invention on ARE luciferase activity of 293T cells
- 100 ⁇ g/mL of the traditional Chinese medicine composition of the present invention has obvious antioxidant effect.
- Embodiment 3 The traditional Chinese medicine composition of the present invention is to the RAW264.7 induced by LPS
- This experiment investigated the effect of the traditional Chinese medicine composition of the present invention on the release of inflammatory factors in RAW264.7 macrophages induced by LPS, and explored the anti-inflammatory effect of the traditional Chinese medicine composition of the present invention.
- cryopreservation tube Take out the cryopreservation tube from the liquid nitrogen tank, quickly put it in a 37°C water bath, and shake it clockwise quickly to completely dissolve the cells within 1-2min.
- the cells were removed from the cryopreservation tube, 3 mL of culture medium (10% FBS+90% DMEM) was added, mixed well and then centrifuged at 800 rpm/min at 4°C for 5 min. Discard the supernatant, resuspend the cell pellet with 5 mL of culture medium, transfer it to a 25 cm 2 culture flask, and culture it in a 37°C constant temperature carbon dioxide cell incubator.
- the cell culture procedure was the same as the subculture experiment, and the cells to be frozen were centrifuged at 4°C and 800rpm/min for 5min.
- the volume ratio of DMEM, fetal bovine serum, and DMSO reagent was 7:2:1 to prepare cell cryopreservation solution, and repeatedly pipet cells with a certain volume of cryopreservation solution to mix the cells evenly.
- 1 mL per vial was divided into cryopreservation tubes, and put into a gradient cooling freezer according to the principle of slow freezing and instant dissolution, and placed in a -80°C refrigerator for 24 hours, then transferred to liquid nitrogen for long-term freezing.
- Cell number/mL (cell number in four grid areas)/4 ⁇ 104 ⁇ dilution factor
- CCK-8 and LDH kits were used to investigate the effect of different concentrations of the traditional Chinese medicine composition of the present invention on the viability of RAW264.7 cells.
- the RAW264.7 cells in the logarithmic growth phase were collected and seeded in 96-well plates at a density of 2 ⁇ 10 5 cells/mL. After 24 hours, 0.01, 0.1, 1, 10, 100, 200, 400, 800, 1000 ⁇ g/mL of the traditional Chinese medicine composition of the present invention were added respectively, 100 ⁇ L per well, 6 duplicate wells for each concentration, and a Control group without adding medicine was set at the same time . After 24 hours of drug treatment, the culture plate was taken out, the supernatant was sucked off, 100 ⁇ L of 10-fold diluted CCK-8 solution was added to each well, and incubated at 37°C for 30 minutes. The absorbance OD value was detected at 450 nm by a microplate reader, and the cell viability was calculated.
- the RAW264.7 cells in the logarithmic growth phase were collected and seeded in 96-well plates at a density of 2 ⁇ 10 5 cells/mL. After 24 hours, 0.01, 0.1, 1, 10, 100, 200, 400, 800, 1000 ⁇ g/mL of the traditional Chinese medicine composition of the present invention were added respectively, 100 ⁇ L per well, 6 duplicate wells for each concentration, and a Control group without adding medicine was set at the same time .
- RAW264.7 cells were seeded in 96-well plates at a density of 2 ⁇ 10 5 cells/mL, and the cells were grouped 24 hours later.
- LPS with a final concentration of 1 ⁇ g/mL was added; in the control group, DMEM was used instead of LPS; in addition to LPS, the culture medium of the drug treatment group was added with final concentrations of 0.01, 0.1, 1, 10, 100, 200, 400, 800, 1000 ⁇ g/mL of Qingjin Yiqi, LPS pre-stimulation for 2 hours, and then LPS stimulation for 20 hours to collect cells for testing.
- the RAW264.7 cells in the logarithmic growth phase were collected and seeded in 96-well plates at a density of 2 ⁇ 10 5 cells/mL. After 24 hours, 0.1, 1, 10, 100, 200, 400, 800, and 1000 ⁇ g/mL of the traditional Chinese medicine composition of the present invention were added respectively, 100 ⁇ L per well, 6 duplicate wells for each concentration, and the Control group and Model without adding medicine were set at the same time. group (1 ⁇ g/mL LPS). After 24 hours of drug treatment, the culture plate was taken out to detect the amount of NO release. Take out Griess Reagent I and II and bring back to room temperature. Dilute standards (1-100 [mu]M) in DMEM + 10% FBS.
- the concentrations of the standards are 0, 1, 2, 5, 10, 20, 40, 60, 100 ⁇ M.
- the experimental data were analyzed using SPSS 25.0 software to conduct one-way ANOVA to evaluate the difference between the means. When P ⁇ 0.05, it was considered to be statistically different, and the data were expressed as mean ⁇ SD.
- CCK-8 and LDH methods were used to detect the influence of the traditional Chinese medicine composition of the present invention on the viability of RAW264.7 cells at 0.01, 0.1, 1, 10, 100, 200, 400, 800, 1000 ⁇ g/mL.
- the results showed that there was no significant difference in the viability of RAW264.7 cells in the 0.01-10 ⁇ g/mL Qingjin Yiqi group compared with the normal control group, and the 100-1000 ⁇ g/mL Qingjin Yiqi group could significantly promote the viability of RAW264.7 cells (P ⁇ 0.01, P ⁇ 0.001).
- the anti-inflammatory effect of the traditional Chinese medicine composition of the present invention was investigated by using the safe concentration of the drug (Fig. 4-Fig. 5).
- LPS stimulation significantly increased the NO expression of RAW264.7 cells (P ⁇ 0.001); compared with the LPS stimulation group, 100-1000 ⁇ g/mL of the Chinese medicine composition of the present invention can significantly inhibit the LPS-induced RAW264.7 Cellular NO release (P ⁇ 0.05, P ⁇ 0.001) ( Figure 6).
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Abstract
Description
Claims (10)
- 一种中药组合物,其由任何形式的如下中药材组成或制成:人参、麦冬、五味子、茯苓、清半夏、玄参、麸炒苍术、陈皮、甘草、柴胡、升麻、薏苡仁、黄芩、马鞭草、芦根和淡竹叶。
- 根据权利要求1的中药组合物,其由如下重量份的中药材组成或制成:人参2-4份、麦冬4-8份、五味子2-4份、茯苓6-10份、清半夏6-10份、玄参4-8份、麸炒苍术4-6份、陈皮4-8份、甘草2-4份、柴胡4-8份、升麻2-4份、薏苡仁8-12份、黄芩8-12份、马鞭草8-12份、芦根12-18份和淡竹叶1-3份。
- 根据权利要求2的中药组合物,其由如下重量份的中药材组成或制成:人参3份、麦冬6份、五味子3份、茯苓8份、清半夏8份、玄参6份、麸炒苍术5份、陈皮6份、甘草3份、柴胡6份、升麻3份、薏苡仁10份、黄芩10份、马鞭草10份、芦根15份和淡竹叶2份。
- 一种中药制剂,其包含权利要求1至3任意一项的中药组合物,以及药剂学上可接受的辅料。
- 根据权利要求4的中药制剂,其中所述药剂学上可接受的辅料选自稀释剂、载体、填充剂、粘合剂、湿润剂、崩解剂、吸收促进剂、表面活性剂、吸附载体和润滑剂。
- 根据权利要求4或5的中药制剂,该制剂为液体制剂、颗粒剂、散剂、丸剂、片剂、胶囊剂、糖浆剂或膏剂。
- 权利要求1至3任意一项的中药组合物在制备用于预防、治疗或缓解感染性疾病后遗症或并发症或促进受损由感染性疾病引起的组织、器官或系统的功能恢复的药物中的用途。
- 权利要求1至3任意一项的中药组合物在制备用于预防、治疗或缓解新冠肺炎后遗症或并发症或促进新冠肺炎患者受损由新冠肺炎引起的组织、器官或系统的功能恢复的药物中的用途。
- 权利要求1至3任意一项的中药组合物在制备用于抗炎和/或抗氧化的药物中的用途。
- 权利要求1至3任意一项的中药组合物在制备用于预防、治疗或缓解感染性疾病后遗症或并发症的药物中的用途,其中所述的后遗症或并发症选自病原微生物急性感染后急腹症;脓毒血症;手术后气虚、大汗淋漓;以及病原微生物感染后身体虚弱、倦怠和乏力。
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