CN104474021A - Traditional Chinese medicine composition for treatment of exterior heat and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treatment of exterior heat and preparation method thereof Download PDF

Info

Publication number
CN104474021A
CN104474021A CN201410693647.7A CN201410693647A CN104474021A CN 104474021 A CN104474021 A CN 104474021A CN 201410693647 A CN201410693647 A CN 201410693647A CN 104474021 A CN104474021 A CN 104474021A
Authority
CN
China
Prior art keywords
chinese medicine
medicine composition
exterior heat
treatment
radix
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201410693647.7A
Other languages
Chinese (zh)
Inventor
罗实
罗红艳
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
YUNNAN LIXIANG PHARMACEUTICAL CO Ltd
Original Assignee
YUNNAN LIXIANG PHARMACEUTICAL CO Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by YUNNAN LIXIANG PHARMACEUTICAL CO Ltd filed Critical YUNNAN LIXIANG PHARMACEUTICAL CO Ltd
Priority to CN201410693647.7A priority Critical patent/CN104474021A/en
Publication of CN104474021A publication Critical patent/CN104474021A/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/60Moraceae (Mulberry family), e.g. breadfruit or fig
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • A61K33/06Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/19Acanthaceae (Acanthus family)
    • A61K36/195Strobilanthes
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • A61K36/233Bupleurum
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/35Caprifoliaceae (Honeysuckle family)
    • A61K36/355Lonicera (honeysuckle)
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • 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
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/539Scutellaria (skullcap)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1617Organic compounds, e.g. phospholipids, fats
    • A61K9/1623Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/55Liquid-liquid separation; Phase separation

Landscapes

  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Biotechnology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Botany (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Neurosurgery (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

The invention relates to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for the treatment of exterior heat and a preparation method thereof. The traditional Chinese medicine composition is prepared from raw materials such as cudrania tricuspidata roots, rhizoma et radix baphicacanthis cusae, gypsum, flos lonicerae, radix bupleuri, radix scutellariae and radix glycyrrhizae. According to the traditional Chinese medicine composition for the treatment of exterior heat provided by the invention, natural edible herbal medicines are selected as raw materials, the natural edible herbal medicines which are accurate in compatibility are synthetically acted, and through strengthening the body resistance to consolidate the constitution, clear internal heat and realize detoxifying, the traditional Chinese medicine composition implements the effective treatment of exterior heat, and has an obvious curative effect on exterior heat symptoms caused by influenza, upper respiratory infection, swelling and pain in throat, amygdalitis, mumps, acute pharyngitis, acute bronchitis, simple pneumonia and the like; the traditional Chinese medicine composition has no toxic and side effect; and the provided preparation method is high in extraction rate, easy to operate, and suitable for industrial production.

Description

Chinese medicine composition for the treatment of exterior heat and preparation method thereof
Technical field
The present invention relates to technical field of Chinese medicines, particularly relate to Chinese medicine composition for the treatment of exterior heat and preparation method thereof.
Background technology
In clinical, the various diseases such as flu, upper respiratory tract infection, laryngopharynx swelling and pain, tonsillitis, parotitis, acute pharyngitis acute bronchitis, simple pneumonia are often with heating paresthesia, wherein, cold, fever is many caused by ailment said due to cold or exposure invasion and attack, the evil poison of diseases caused by exogenous pathogenic factor, be clinical in the most common disease, and the other diseases such as upper respiratory tract infection, laryngopharynx swelling and pain, tonsillitis, parotitis, acute pharyngitis acute bronchitis, simple pneumonia also belong to caused by exopathogen invasion and attack, the people Gao Re and these diseases are caused a disease usually.The treatment of this type of febrile conditions also be there is no at present to the medicine of the special curative effect of tool, especially the medicine that the hyperpyrexia disease disease reaching more than 39 DEG C to body temperature has significant curative effect is rare especially, and a lot of medicine has toxic and side effects more, take rear often with reactions such as drowsiness, swelling, as medicines such as virazoles, the damage of the hemopoietic systems such as anemia also can be caused.
Summary of the invention
The object of the invention is, for prior art Problems existing, provide Chinese medicine composition for the treatment of exterior heat and preparation method thereof, by eliminating pathogenic factor for supporting vital QI, improve immunity of organisms, heat-clearing and toxic substances removing, the heating paresthesia of patient is efficiently treated in time, and occurs without other toxic and side effects.
The technical scheme that the present invention deals with problems is: the Chinese medicine composition providing treatment exterior heat, containing following raw material: Cudrania tricuspidata (Carr.) Bur.ex Lavallia, Rhizoma Et Radix Baphicacanthis Cusiae, Gypsum Fibrosum, Flos Lonicerae, Radix Bupleuri, Radix Scutellariae, Radix Glycyrrhizae.
Treat in the Chinese medicine composition of exterior heat in the present invention, the weight of described each raw material dosage is as follows: Cudrania tricuspidata (Carr.) Bur.ex Lavallia 400 ~ 600 parts, Rhizoma Et Radix Baphicacanthis Cusiae 200 ~ 300 parts, 250 ~ 400 parts, Gypsum Fibrosum, Flos Lonicerae 160 ~ 240 parts, Radix Bupleuri 130 ~ 170 parts, Radix Scutellariae 130 ~ 170 parts, 40 ~ 60 parts, Radix Glycyrrhizae.
Treat in the Chinese medicine composition of exterior heat in the present invention, the weight of described each raw material dosage is as follows: Cudrania tricuspidata (Carr.) Bur.ex Lavallia 500 parts, Rhizoma Et Radix Baphicacanthis Cusiae 250 parts, 333 parts, Gypsum Fibrosum, Flos Lonicerae 200 parts, Radix Bupleuri 167 parts, Radix Scutellariae 167 parts, 50 parts, Radix Glycyrrhizae.
Treat in the Chinese medicine composition of exterior heat in the present invention, the extract containing all or part of described raw material, described extract is ethanol extraction or water extract.
The Chinese medicine composition that the present invention treats exterior heat is granule, tablet, capsule, decoction, unguentum, pill, mixture, syrup as the dosage form of medicament.
The Chinese medicine composition that the present invention treats exterior heat is preferably granule as the dosage form of medicament.
The Chinese medicine composition that the present invention treats exterior heat can adopt the customary preparation methods of Chinese medicine to prepare.And above-mentioned each raw material is made the preferred preparation method of Chinese medicine composition that the present invention treats exterior heat and comprise the steps:
(1) Cudrania tricuspidata (Carr.) Bur.ex Lavallia, Rhizoma Et Radix Baphicacanthis Cusiae, Gypsum Fibrosum, Flos Lonicerae, Radix Bupleuri, Radix Scutellariae, Radix Glycyrrhizae is taken according to the proportioning raw materials of the Chinese medicine composition of above-mentioned treatment exterior heat, each raw material is pulverized respectively, obtains Cudrania tricuspidata (Carr.) Bur.ex Lavallia powder, Rhizoma Et Radix Baphicacanthis Cusiae powder, Gypsum Fibrosum powder, Flos Lonicerae powder, Radix Bupleuri powder, Radix Scutellariae powder and Radix Glycyrrhizae powder;
(2) in the Rhizoma Et Radix Baphicacanthis Cusiae powder of gained in step (1), add ethanol, carry out heating and refluxing extraction, then filter, gained filtrate and medicinal residues retain for subsequent use respectively;
(3) the Cudrania tricuspidata (Carr.) Bur.ex Lavallia powder of the medicinal residues of step (2) gained and step (1) gained, Gypsum Fibrosum powder, Flos Lonicerae powder, Radix Bupleuri powder, Radix Scutellariae powder and Radix Glycyrrhizae powder are mixed, decoct with water, then filter, retain filtrate stand-by.
(4) by step (3) gained filtrate heating simmer down to clear paste, then, gained clear paste is cooled to room temperature;
(5) in the clear paste of the rear gained of step (4) cooling, add ethanol, then mix homogeneously with the filtrate of step (2) gained, leave standstill, filter, after being reclaimed by the ethanol in gained filtrate, the Chinese medicine composition of exterior heat must be treated.
Preferably, the Chinese medicine composition for the treatment of exterior heat because of the present invention is oral administration, treat in the preparation method of the Chinese medicine composition of exterior heat in the present invention, can according to the degree of exterior heat patient and actual needs, for ease of taking, after described step (5), step (5) gained filtrate can be made the medicaments such as granule, tablet, capsule, decoction, unguentum, pill, mixture, syrup.
Preferably, treat in the present invention in the preparation method of the Chinese medicine composition of exterior heat, also comprise the steps: after carrying out described step (5)
(6) after being reclaimed by step (5) ethanol, the remaining liquid concentration of institute is thick paste;
(7) in step (6) gained thick paste, add filler, correctives, mixing, makes granule, drier, obtains the Chinese medicine composition of the treatment exterior heat of bead dosage form, and products obtained therefrom is light brown yellow extremely tan granule: sweet, the micro-hardship of taste.
Preferably, treat in the preparation method of the Chinese medicine composition of exterior heat in the present invention, described filler is one or more the combination in lactose, mannitol, dextrin and soluble starch; Be preferably dextrin, soluble starch; In Cudrania tricuspidata (Carr.) Bur.ex Lavallia consumption 400 ~ 600 parts, the consumption of described filler is preferably 100 ~ 400 parts, and preferably consumption is 150 ~ 250 parts.
Preferably, treat in the present invention in the preparation method of the Chinese medicine composition of exterior heat, described correctives be that steviosin, aspartame, protein sugar, Ansai are close, a kind of in xylitol or fructose or or two or more combination; Be preferably steviosin, aspartame (also known as aspartame); In Cudrania tricuspidata (Carr.) Bur.ex Lavallia consumption 400 ~ 600 parts, the consumption of described correctives is preferably 5 ~ 50 parts, and preferably consumption is 10 ~ 20 parts.
Present invention also offers the purposes of Chinese medicine composition in the medicine of preparation treatment cold, fever, upper respiratory tract infection heating, laryngopharynx swelling and pain heating, tonsillitis heating, parotitis heating, acute pharyngitis heating, acute bronchitis heating, simple pneumonia heating that the present invention treats exterior heat.
The present invention's Chinese medicine composition for the treatment of exterior heat and preparation method thereof is that inventor has done nearly 100 times experiment and formula adjustment and carried out developing according to tcm theory and obtain.Below above-mentioned raw materials medicine selected is in the present invention described below:
Raw materials used Cudrania tricuspidata (Carr.) Bur.ex Lavallia records in medical material standard the Dai nationality of Yunnan Province medicine fascicle, and raw material Cudrania tricuspidata (Carr.) Bur.ex Lavallia is the dry root of moraceae plants Zhe Shu; Cudrania tricuspidata (Carr.) Bur.ex Lavallia is cool in nature, lightly seasoned, micro-hardship; Tool heat-clearing and toxic substances removing and dampness removing, the effect of invigorating blood circulation.Raw materials used Rhizoma Et Radix Baphicacanthis Cusiae records in Chinese Pharmacopoeia (2010 editions one), and raw material Rhizoma Et Radix Baphicacanthis Cusiae is dry rhizome and the root of Jue Qing section plant Acanthaceous indigo, and Xia Qiu bis-season excavates, and the removing aerial stem of plant, cleans, dry; Rhizoma Et Radix Baphicacanthis Cusiae is cold in nature, bitter in the mouth, tool heat-clearing and toxic substances removing, and removing heat from blood is subsided a swelling effect; Be used for the treatment of pestilence seasonal noxious pathogen, fever and headache, maculae caused by violent heat pathogen, erysipelas.Raw materials used Gypsum Fibrosum records in Chinese Pharmacopoeia (2010 editions one), and raw gypsum is Sulfates mineral anhydrite race Gypsum Fibrosum, and main component is hydrous calcium sulfate (GaSO 42H 2o), after excavating, except roguing stone and silt; Gypsum Fibrosum is cold in nature, acrid in the mouth, effect that tool clearing away heat-fire, relieving restlessness quench the thirst; Be used for the treatment of fever caused by exogenous pathogenic factors, high hot excessive thirst, dyspnea and cough due to lung-heat, the high Sheng of stomach-fire, headache, toothache.Raw materials used Flos Lonicerae is recorded in Chinese Pharmacopoeia (2010 editions one), and Flos Lonicerae is the flower that the dry flower of caprifoliaceae plant Radix Ophiopogonis or band are just opened, early summer the flowers are in blossom put before gather, dry; Sweet in the mouth cold in nature, tool heat-clearing and toxic substances removing, effect of dispelling wind and heat pathogens; Be used for the treatment of carbuncle furuncle, sore throat, erysipelas, toxic-heat and blood stasis, anemopyretic cold, epidemic febrile disease heating.Raw materials used Radix Bupleuri records in Chinese Pharmacopoeia (2010 editions one), and raw material Radix Bupleuri is the dry root of umbelliferae bupleurum or Radix Bupeuri Scorzonerfolii., different by character, practises title " Radix Bupleuri " and " Radix Bupleuri Scorzonerifolii " respectively; Spring, Qiu Erji excavate, removing stem and leaf and silt, dry; Bitter in the mouth, cold nature, tool evacuation is brought down a fever, effect of dispersing the stagnated live-QI to relieve the stagnation of QI, elevate a turnable ladder yang-energy; Be used for the treatment of cold, fever, alternate attack of chill and fever, distending pain in the chest and hypochondrium, menoxenia, uterine prolapse, proctoptosis.Raw materials used Radix Scutellariae records in Chinese Pharmacopoeia (2010 editions one), and raw material Radix Scutellariae is the dry root of labiate Radix Scutellariae, and season in spring and autumn two excavates, and removing fibrous root and silt, hit rough bark after solarization, dry; Tool clearing away dryness is wet, eliminating fire and detoxication, hemostasis, antiabortive effect; Be used for the treatment of hygropyrexia, heat-damp in summer, vomiting and nausea uncomfortable in chest, damp and hot feeling of fullness, dysentery, jaundice, cough due to lung-heat, high hot excessive thirst, heat in blood tell nosebleed, carbuncle sore tumefacting virus, frequent fetal movement.Raw materials used Radix Glycyrrhizae is recorded in Chinese Pharmacopoeia (2010 editions one), and raw material Radix Glycyrrhizae is the dry root welding technology of glycyrrhizic legume, Glycyrrhiza inflata Bat., stroke Glycyrrhiza glabra L., and spring, Qiu Erji excavate, and removing fibrous root, dries; Radix Glycyrrhizae nature and flavor are sweet flat, effect of tool invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expectorant cough-relieving, relieving spasm to stop pain, coordinating the actions of various ingredients in a prescription, is used for the treatment of the anxious pain of weakness of the spleen and stomach, fatigue and weakness, cardiopalmus shortage, cough with copious phlegm, gastral cavity abdomen and extremity contraction, carbuncle sore tumefacting virus, cushion toxicity and strong.
Chinese medicine composition for the treatment of exterior heat provided by the invention and preparation method thereof, natural edible-plant medicine is selected to be raw material, each taste medicine comprehensive function that compatibility is precise and appropriate, just consolidated by reason, Qinghuo Jiedu, realizes effectively treating exterior heat, especially treats the heating paresthesia that flu, upper respiratory tract infection, laryngopharynx swelling and pain, tonsillitis, parotitis, acute pharyngitis, acute bronchitis and simple pneumonia cause, evident in efficacy, and have no side effect; Preparation method extraction ratio is high, easy and simple to handle, is suitable for industrialization promotion and produces.
Detailed description of the invention
The Chinese medicine composition for the treatment of exterior heat provided by the invention, based on medical research and clinical experience for many years, in conjunction with modern medicine mechanism, screening active drug, the over one hundred example of clinical observation, has the advantages that instant effect, stable curative effect are reliable, nontoxic, have no side effect; The hot patient of height caused by the diseases such as flu, upper respiratory tract infection, laryngopharynx swelling and pain, tonsillitis, parotitis, acute pharyngitis acute bronchitis, simple pneumonia is taken to the Chinese medicine composition for the treatment of exterior heat of the present invention, through the Curative effect of over one hundred routine patient, effective percentage is up to 90.8%, and the action effect of bringing down a fever fast and is efficiently remarkable.
The Chinese drug preparation field that the is operating as routine techniques of the active Chinese drug component component extract carried out in embodiments of the present invention.The object of embodiment is the regular dosage form illustrating that Chinese medicine composition of the present invention can be made, but not for limiting its protection domain or affecting it openly fully.
Raw material is taken: the weight of described each raw material dosage is as follows: Cudrania tricuspidata (Carr.) Bur.ex Lavallia 400 ~ 600 parts, Rhizoma Et Radix Baphicacanthis Cusiae 200 ~ 300 parts, 250 ~ 400 parts, Gypsum Fibrosum, Flos Lonicerae 160 ~ 240 parts, Radix Bupleuri 130 ~ 170 parts, Radix Scutellariae 130 ~ 170 parts, 40 ~ 60 parts, Radix Glycyrrhizae by following proportioning.
Preparation method is as follows:
(1) alleged each raw material is pulverized respectively, obtain Cudrania tricuspidata (Carr.) Bur.ex Lavallia powder, Rhizoma Et Radix Baphicacanthis Cusiae powder, Gypsum Fibrosum powder, Flos Lonicerae powder, Radix Bupleuri powder, Radix Scutellariae powder and Radix Glycyrrhizae powder;
(2) in the Rhizoma Et Radix Baphicacanthis Cusiae powder of gained in step (1), add ethanol, carry out heating and refluxing extraction, then filter, gained filtrate and medicinal residues retain for subsequent use respectively;
(3) the Cudrania tricuspidata (Carr.) Bur.ex Lavallia powder of the medicinal residues of step (2) gained and step (1) gained, Gypsum Fibrosum powder, Flos Lonicerae powder, Radix Bupleuri powder, Radix Scutellariae powder and Radix Glycyrrhizae powder are mixed, decoct with water, then filter, retain filtrate stand-by.
(4) by step (3) gained filtrate heating simmer down to clear paste, then, gained clear paste is cooled to room temperature;
(5) in the clear paste of the rear gained of step (4) cooling, add ethanol, then mix homogeneously with the filtrate of step (2) gained, leave standstill, filter, after being reclaimed by the ethanol in gained filtrate, the Chinese medicine composition of exterior heat must be treated.
The Chinese medicine composition for the treatment of exterior heat because of the present invention is oral administration, according to degree and the actual needs of exterior heat patient, for ease of taking, after described step (5), step (5) gained filtrate can be made the medicaments such as granule, tablet, capsule, decoction, unguentum, pill, mixture, syrup; Being preferably bead dosage form, also comprising the steps: for preparing bead dosage form
(6) after being reclaimed by step (5) ethanol, the remaining liquid concentration of institute is thick paste;
(7) in step (6) gained thick paste, add filler, correctives, mixing, makes granule, drier, obtains the Chinese medicine composition of the treatment exterior heat of bead dosage form, then carries out packed respectively.
In the Chinese medicine composition preparation method for the treatment of exterior heat provided by the invention, can need according to the treatment of different syndromes the determination carrying out packed quality, the explosive payload of every bag is preferably 4 ~ 6g, and every bag contains Flos Lonicerae with chlorogenic acid (C l6h l8o 9) meter, be no less than 20.0mg.
In the preparation method of the Chinese medicine composition of the treatment exterior heat that the invention described above provides, described filler is one or more the combination in lactose, mannitol, dextrin and soluble starch; Be preferably dextrin, soluble starch; Described correctives is that steviosin, aspartame, protein sugar, Ansai are close, a kind of in xylitol or fructose or or two or more combination; Be preferably steviosin, aspartame (also known as aspartame).
In the preparation method of the Chinese medicine composition of the treatment exterior heat provided in the invention described above, prepare situation according to reality, involved by add second alcohol and water amount be preferred with 1.5 ~ 3 of dose volume times; For ensureing the safe ready retaining completely and carry and take after finished product of finished product medicament effective ingredient, the granularity of each raw material pulverizing is common coarse powder by step (1); In step (2), ethanol used is preferably the ethanol of mass percentage more than 60%, and the number of times of heating and refluxing extraction is preferably 2 ~ 3 times, and the time of each reflux is preferably 2 ~ 3 hours; The number of times decocted in step (3) is preferably 2 ~ 3 times, and each decocting time is preferably 2 ~ 3 hours; The temperature that in step (4), filtrate is concentrated is preferably 80 DEG C, and the relative density of gained clear paste is preferably 1.38 ~ 1.40g/cm 3; Step (5) ethanol used is preferably the ethanol of mass percentage more than 60%, and after mixed liquor is even, the time left standstill is preferably more than 24 hours, and the method reclaiming ethanol is preferably distilling under reduced pressure and reclaims; Temperature concentrated in step (6) is preferably 80 DEG C, and the relative density of gained thick paste is preferably 1.38 ~ 1.40g/cm 3.
Be described below by specific embodiment.
Embodiment 1
Raw material (g) is taken: Cudrania tricuspidata (Carr.) Bur.ex Lavallia 400, Rhizoma Et Radix Baphicacanthis Cusiae 200, Gypsum Fibrosum 250, Flos Lonicerae 160, Radix Bupleuri 130, Radix Scutellariae 130, Radix Glycyrrhizae 40 by following proportioning.
Preparation method is as follows:
(1) alleged each raw material is pulverized respectively, obtain Cudrania tricuspidata (Carr.) Bur.ex Lavallia powder, Rhizoma Et Radix Baphicacanthis Cusiae powder, Gypsum Fibrosum powder, Flos Lonicerae powder, Radix Bupleuri powder, Radix Scutellariae powder and Radix Glycyrrhizae powder;
(2) in the Rhizoma Et Radix Baphicacanthis Cusiae powder of gained in step (1), add ethanol, carry out heating and refluxing extraction, then filter, gained filtrate and medicinal residues retain for subsequent use respectively;
(3) the Cudrania tricuspidata (Carr.) Bur.ex Lavallia powder of the medicinal residues of step (2) gained and step (1) gained, Gypsum Fibrosum powder, Flos Lonicerae powder, Radix Bupleuri powder, Radix Scutellariae powder and Radix Glycyrrhizae powder are mixed, decoct with water, then filter, retain filtrate stand-by.
(4) by step (3) gained filtrate heating simmer down to clear paste, then, gained clear paste is cooled to room temperature;
(5) in the clear paste of the rear gained of step (4) cooling, add ethanol, then mix homogeneously with the filtrate of step (2) gained, leave standstill, filter, after being reclaimed by the ethanol in gained filtrate, the Chinese medicine composition of exterior heat must be treated.
(6) after being reclaimed by step (5) ethanol, the remaining liquid concentration of institute is thick paste;
(7) in step (6) gained thick paste, add filler 100g, correctives 5g, mixing, makes granule, drier, and obtain the Chinese medicine composition 400g of the treatment exterior heat of bead dosage form, then carry out packed respectively, the explosive payload of every bag is 4g; Every bag contains Flos Lonicerae with chlorogenic acid (C l6h l8o 9) meter, be no less than 20.0mg.
In above-described embodiment, described filler is lactose; Described correctives is steviosin.
In the above-described embodiments, prepare situation according to reality, involved by add the amount of second alcohol and water with 1.5 of dose volume times; In step (2), ethanol used is the ethanol of mass percentage 60%, and the number of times of heating and refluxing extraction is 2 times, and the time of each reflux is 2 hours; The number of times decocted in step (3) is preferably 2 times, and each decocting time is 2 hours; The temperature that in step (4), filtrate is concentrated is 80 DEG C, and the relative density of gained clear paste is 1.38g/cm 3; Step (5) ethanol used is preferably the ethanol of mass percentage 60%, and after mixed liquor is even, the time left standstill is 24 hours, and the method reclaiming ethanol is that distilling under reduced pressure is reclaimed; Temperature concentrated in step (6) is 80 DEG C, and the relative density of gained thick paste is 1.38g/cm 3.
Embodiment 2
Raw material (g) is taken: Cudrania tricuspidata (Carr.) Bur.ex Lavallia 600, Rhizoma Et Radix Baphicacanthis Cusiae 300, Gypsum Fibrosum 400, Flos Lonicerae 240, Radix Bupleuri 170, Radix Scutellariae 170, Radix Glycyrrhizae 60 by following proportioning; Basic preparation method, with embodiment 1, obtains the Chinese medicine composition 400g of the treatment exterior heat of bead dosage form, carries out packed respectively, and the explosive payload of every bag is 6g; Every bag contains Flos Lonicerae with chlorogenic acid (C l6h l8o 9) meter, be no less than 2O.Omg.
In the above-described embodiments, the amount of second alcohol and water is added involved by with 3 of dose volume times; In step (7), add that filler is mannitol 200g, correctives is aspartame 50g; In step (2), ethanol used is the ethanol of mass percentage 60%, and the number of times of heating and refluxing extraction is 3 times, and the time of each reflux is 3 hours; The number of times decocted in step (3) is preferably 3 times, and each decocting time is 3 hours; The temperature that in step (4), filtrate is concentrated is 80 DEG C, and the relative density of gained clear paste is 1.40g/cm 3; Step (5) ethanol used is preferably the ethanol of mass percentage 60%, and after mixed liquor is even, the time left standstill is 28 hours, and the method reclaiming ethanol is that distilling under reduced pressure is reclaimed; Temperature concentrated in step (6) is 80 DEG C, and the relative density of gained thick paste is 1.40g/cm 3.
Embodiment 3
Raw material (g) is taken: Cudrania tricuspidata (Carr.) Bur.ex Lavallia 500, Rhizoma Et Radix Baphicacanthis Cusiae 250, Gypsum Fibrosum 333, Flos Lonicerae 200, Radix Bupleuri 167, Radix Scutellariae 167, Radix Glycyrrhizae 50 by following proportioning; Basic preparation method, with embodiment 1, obtains the Chinese medicine composition 400g of the treatment exterior heat of bead dosage form, carries out packed respectively, and the explosive payload of every bag is 5g; Every bag contains Flos Lonicerae with chlorogenic acid (C l6h l8o 9) meter, be no less than 20.0mg.
In the above-described embodiments, the amount of second alcohol and water is added involved by with 2 of dose volume times; In step (7), add that filler is dextrin 220g, correctives is protein sugar 10g; In step (2), ethanol used is the ethanol of mass percentage 60%, and the number of times of heating and refluxing extraction is 2 times, and the time of each reflux is 2 hours; The number of times decocted in step (3) is preferably 3 times, and each decocting time is 2 hours; The temperature that in step (4), filtrate is concentrated is 80 DEG C, and the relative density of gained clear paste is 1.39g/cm 3; Step (5) ethanol used is preferably the ethanol of mass percentage 60%, and after mixed liquor is even, the time left standstill is 24 hours, and the method reclaiming ethanol is that distilling under reduced pressure is reclaimed; Temperature concentrated in step (6) is 80 DEG C, and the relative density of gained thick paste is 1.39g/cm 3.
Embodiment 4
Raw material (g) is taken: Cudrania tricuspidata (Carr.) Bur.ex Lavallia 500, Rhizoma Et Radix Baphicacanthis Cusiae 250, Gypsum Fibrosum 333, Flos Lonicerae 200, Radix Bupleuri 167, Radix Scutellariae 167, Radix Glycyrrhizae 50 by following proportioning; Preparation method with embodiment 1, unlike: in step (7), add that filler is 250g, correctives is 20g.
Basic preparation method, with embodiment 1, obtains the Chinese medicine composition 400g of the treatment exterior heat of bead dosage form, carries out packed respectively, and the explosive payload of every bag is 6g; Every bag contains Flos Lonicerae with chlorogenic acid (C l6h l8o 9) meter, be no less than 20.0mg.
In the above-described embodiments, the amount of second alcohol and water is added involved by with 2.5 of dose volume times; In step (7), add that filler is soluble starch 250g, correctives is the close 10g in Ansai; In step (2), ethanol used is the ethanol of mass percentage 60%, and the number of times of heating and refluxing extraction is 2 times, and the time of each reflux is 2.5 hours; The number of times decocted in step (3) is preferably 3 times, and each decocting time is 2.5 hours; The temperature that in step (4), filtrate is concentrated is 80 DEG C, and the relative density of gained clear paste is 1.38g/cm 3; Step (5) ethanol used is preferably the ethanol of mass percentage 60%, and after mixed liquor is even, the time left standstill is 24 hours, and the method reclaiming ethanol is that distilling under reduced pressure is reclaimed; Temperature concentrated in step (6) is 80 DEG C, and the relative density of gained thick paste is 1.39g/cm 3.
Embodiment 5
Raw material (g) is taken: Cudrania tricuspidata (Carr.) Bur.ex Lavallia 500, Rhizoma Et Radix Baphicacanthis Cusiae 250, Gypsum Fibrosum 333, Flos Lonicerae 200, Radix Bupleuri 167, Radix Scutellariae 167, Radix Glycyrrhizae 50 by following proportioning; Basic preparation method, with embodiment 1, obtains the Chinese medicine composition 400g of the treatment exterior heat of bead dosage form, carries out packed respectively, and the explosive payload of every bag is 5g; Every bag contains Flos Lonicerae with chlorogenic acid (C l6h l8o 9) meter, be no less than 20.0mg.
In the above-described embodiments, the amount of second alcohol and water is added involved by with 1.5 ~ 2.5 of dose volume times; In step (7), add that filler is dextrin 166.7g, correctives is xylitol 19g; In step (2), ethanol used is the ethanol of mass percentage 60%, and the number of times of heating and refluxing extraction is 2 times, and the time of each reflux is 2 hours; The number of times decocted in step (3) is preferably 3 times, and each decocting time is 2 hours; The temperature that in step (4), filtrate is concentrated is 80 DEG C, and the relative density of gained clear paste is 1.38g/cm 3; Step (5) ethanol used is preferably the ethanol of mass percentage 60%, and after mixed liquor is even, the time left standstill is 24 hours, and the method reclaiming ethanol is that distilling under reduced pressure is reclaimed; Temperature concentrated in step (6) is 80 DEG C, and the relative density of gained thick paste is 1.40g/cm 3.
The trait expression of embodiment 1 to embodiment 5 products obtained therefrom is that light brown yellow is to tan granule, sweet, the micro-hardship of taste.
With embodiment 5 products obtained therefrom for sample, the Chinese medicinal composition granules of prepared treatment exterior heat is differentiated and Composition analyzed.
With embodiment 5 products obtained therefrom for sample, differentiate that situation is as follows according to national Chinese medicine standard:
(1) get this product 10g, porphyrize, add methanol 30ml, supersound process 15 minutes, filters, filtrate evaporate to dryness, residue adds water 20ml, and heating makes dissolving, salt adding acid for adjusting pH value to 2 ~ 3,3 times are extracted with ethyl acetate jolting, each 20ml, combined ethyl acetate liquid, evaporate to dryness, residue adds methanol 5ml makes dissolving, as need testing solution.Separately get chlorogenic acid reference substance, add methanol and make the solution of every lml containing lmg, product solution in contrast.According to thin layer chromatography (Chinese Pharmacopoeia version in 2010 annex VI B) test, draw each 1 ~ 2 μ l of above-mentioned two kinds of solution, put respectively on same polyamide film, take acetic acid as developing solvent, launch, take out, dry, inspect under putting ultra-violet lamp (365nm).In test sample chromatograph, on the position corresponding to reference substance chromatograph, the fluorescence speckle of aobvious same color.
(2) get this product 15g, porphyrize, add methylene chloride 30ml, supersound process 15 minutes, filters, filtrate evaporate to dryness, and the residue 0.5ml that adds methylene chloride makes dissolving, as need testing solution.Separately get indirubin reference substance, add methylene chloride and make the solution of every lml containing 0.5mg, product solution in contrast.Test according to thin layer chromatography (Chinese Pharmacopoeia version in 2010 annex VI B), draw each 10 μ l of above-mentioned two kinds of solution, put respectively on same silica gel g thin-layer plate, with toluene-dichloromethane-acetone (5:4:1) for developing solvent, launch, take out, dry, inspect in the sunlight immediately.In test sample chromatograph, on the position corresponding to reference substance chromatograph, aobvious identical aubergine speckle.
(3) get baicalin reference substance, add methanol and make the solution of every lml containing lmg, product solution in contrast.Test according to thin layer chromatography (Chinese Pharmacopoeia version in 2010 annex VI B), draw the need testing solution under the item of [discriminating] (1) and each 2 ~ 10 μ l of above-mentioned reference substance solution, put respectively on the same silica gel g thin-layer plate being adhesive with the carboxymethylcellulose sodium solution containing 4% sodium acetate, with ethyl acetate-butanone-formic acid-water (5:3:1:1) for developing solvent, launch, take out, dry, spray with 5% ferric chloride alcoholic solution.In test sample chromatograph, on the position corresponding to reference substance chromatograph, the speckle of aobvious same color.
(4) get this product 15g, porphyrize, add ethyl acetate 30ml, supersound process 15 minutes, filter, filtrate evaporate to dryness, residue adds methanol 0.5ml makes dissolving, as need testing solution.Separately get and open up tree root control medicinal material 0.5g, add water 40ml, decocts 2 hours, and filter, filtrate evaporate to dryness, adds 60% ethanol and make dissolving, and filter, filtrate evaporate to dryness, residue adds methanol 10ml makes dissolving, medical material solution in contrast.Test according to thin layer chromatography (Chinese Pharmacopoeia version in 2010 annex VI B), draw need testing solution 10 μ l, control medicinal material solution 5 μ l, put respectively on same silica gel g thin-layer plate, with methylene chloride-methanol (9:1) for developing solvent, launch, take out, dry, spray, with 10% ethanol solution of sulfuric acid, is heated to speckle Xian Se Cheongju clear.In test sample chromatograph, on the position corresponding to control medicinal material chromatograph, the speckle of aobvious same color.
Every regulation (Chinese Pharmacopoeia version in 2010 annex I C) that check result is relevant under meeting granule item.
This product assay is determined as follows according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 annex VI D):
Chromatographic condition and system suitability: take octadecylsilane chemically bonded silica as filler; With methanol-water-glacial acetic acid-triethylamine (15:85:1:0.3) for mobile phase: determined wavelength is for 327nm.Number of theoretical plate calculates should be not less than 3000 by chlorogenic acid peak.
The preparation of reference substance solution: get chlorogenic acid reference substance appropriate, accurately weighed, add 50% methanol and make the solution of every lml containing 40 μ g, to obtain final product.
The preparation of need testing solution: get this product content under content uniformity item, mixing, porphyrize, get about 1.2g, accurately weighed, put in tool plug conical flask, precision adds 50% methanol 50ml, close plug, weighed weight, supersound process (power 250W, frequency 35kHz) 10 minutes, lets cool, supply the weight of less loss with 50% methanol, shake up, filter, get subsequent filtrate, to obtain final product.
Algoscopy: accurate absorption reference substance solution and each 5 μ l of need testing solution respectively, injection liquid chromatography, measures, to obtain final product.
Assay result: the every packed 5g of this product, every bag contains Flos Lonicerae with chlorogenic acid (C l6h l8o 9) meter, be no less than 20.0mg.
With embodiment 5 products obtained therefrom for sample, the evaluation of pesticide effectiveness of the Chinese medicine composition for the treatment of exterior heat of the present invention being carried out treating to exterior heat is as follows:
(1) mouse writhing method carries out analgesic activity experiment
Experiment material
Animal: mice, ICR, body weight 18-22g, male and female half and half, are provided by natural drug pharmacology key lab of Yunnan Province, the quality certification: real dynamic No. 9806 of Yunnan.
Medicine: sample 25g, the solution being made into 93.75%, 62.5% and 31.25% (with crude drug) concentration in water for.Etidocine tablet, lot number: 970704,25mg/ sheet, pharmaceutical factory of Jintan City of Jiangsu Province product, the concentration being made into 0.1% with water for.
Experimental technique and result
Get mice 50, be divided into 5 groups at random, often organize 10, male and female half and half.If blank group (C), feedwater; The basic, normal, high dosage group (L, M, H) of sample, to the sample medicinal liquid of 31.25%, 62.5%, 93.75%; Positive controls (S), to 0.1% indometacin medicinal liquid.Each group all by 20mg/kg (ig) administration, 40min after administration, each treated animal is all to 0.6%HAC10ml/kg (ip) induced pain, and after record injection algogen, every animal writhing number of times in 20min, the results are shown in Table 1.
The Chinese medicine composition of table 1 treatment exterior heat of the present invention turns round the impact of stopping reaction on mice
Note: compare with C group, t checks.
Result shows, the Chinese medicine composition 18.75g/kg (being equivalent to 15 times of clinical day for human beings dosage) for the treatment of exterior heat of the present invention obviously can reduce the reaction of lumbar injection 0.6%HAC induced mice writhing pain, difference has significant (P<0.05), suppression ratio is 26.2%, shows that the Chinese medicine composition for the treatment of exterior heat of the present invention has good analgesic activity.
(2) antiinflammatory action experiment is carried out with mice bulge of the ear method
Experiment material
Animal: mice, ICR, body weight 18-22g, female, provided by natural drug pharmacology key lab of Yunnan Province, the quality certification: real dynamic No. 9806th, the card in Yunnan.
Medicine: sample 25g, is made into 31.25%, 62.5% with water, the solution of 93.75% (in crude drug) for.Etidocine tablet, lot number: 970704,25mg/ sheet, pharmaceutical factory of Jintan City of Jiangsu Province product, the concentration being made into 0.1% with water for.
Experimental technique and result
Get male mice 50, be divided into 5 groups at random, often organize 10, male and female standby half.If blank group (C), feedwater; The basic, normal, high dosage group (L, M, H) of sample, to the sample medicinal liquid of 31.25%, 62.5%, 93.75%; Positive controls (S), to the sample medicinal liquid of 0.1%.Each group all by 20mg/kg (ig) administration, 40min after administration, be coated with the mixing of 0.1ml Oleum Tiglii in mice left ear tow sides and cause scorching liquid (causing in scorching liquid containing 2% Oleum Tiglii, 20% dehydrated alcohol, 5% distilled water and 73% ether), cause scorching rear 4h, de-cervical vertebra puts to death mice, cuts two ears along auricle baseline, round auricle is laid in left and right ear same area respectively with 9mn diameter card punch, weigh, deduct auris dextra sheet weight for swelling with the left auricle weight of every Mus, the results are shown in Table 2.
The Chinese medicine composition of table 2 treatment exterior heat of the present invention is on the impact of Mice Auricle inflammatory swelling
Note: compare with C group, t checks or corrects t inspection.
Result shows, Chinese medicine composition 12.5g/kg and 18.75g/kg (10 times and 15 times for clinical day for human beings dosage) for the treatment of exterior heat of the present invention all can obviously suppress Oleum Tiglii mixing to cause scorching liquid induced mice ear corridor inflammatory swelling (P>0.01), suppression ratio is respectively 25.9% and 27.8%, shows that the Chinese medicine composition for the treatment of exterior heat of the present invention has antiinflammatory action.
(3) refrigeration function experiment
Experiment material
Animal: Japan large ear rabbit, body weight l.8-2.2kg, male half and half, provided by animal housing of unming Medical College, the quality certification: cloud moves No. 99003rd, pipe word.
Medicine: sample 25g, is made into 31.25%, 62.5% with water, the solution of 93.75% (in crude drug).With aspirin tablet, lot number: 970708,40mg/ sheet, Kunming friendship pharmaceutical factory product, the concentration being made into 0.5% with water for, escherichia coli endotoxin, Pi number: 981,9000EU/ props up, and is provided by Nat'l Pharmaceutical & Biological Products Control Institute, with sodium chloride injection be made into 30EU/ml solution for.
Experimental technique and result
Get Japan large ear rabbit some, survey body temperature every day once, for three days on end, rabbit is made to adapt to measuring operation, Thermal preference is at 38.0 ~ 39.6 DEG C and the rabbit of body temperature fluctuation below 0.3 DEG C is qualified rabbit, gets qualified rabbit 30, and interval 30min surveys body temperature 2 times continuously, using every rabbit meansigma methods as this rabbit basal body temperature, be divided into 5 groups by basal body temperature stratified random, often organize 6, male and female half and half, if empty map group (C), to NS; The basic, normal, high dosage group (L, M, H) of sample, to the sample medicinal liquid of 31.25%, 62.5%, 93.75%; Positive controls (S), to 0.5% aspirin tablet medicinal liquid.Each group all by 20mg/kg (ig) administration, after administration lh, every rabbit is all from auricular vein Escherichia Coli Injection endotoxin solution 1ml/kg (30EU/ml), and the body temperature of 1h, 2h, 3h, 4h after record endotoxin injection, the results are shown in Table 3.
The refrigeration function of the Chinese medicine composition of table 3 treatment exterior heat of the present invention
Note: * P<0.05, * * <0.01, compares with C group, t inspection or correction t inspection
Result shows, Chinese medicine composition 12.5g/kg and 18.75g/kg (being equivalent to 10 times and 15 times of clinical day for human beings dosage) for the treatment of exterior heat of the present invention all obviously can suppress intravenous injection escherichia coli endotoxin caused rabbit daughter temperature rising (P<0.05, P<0.01), show that the Chinese medicine composition for the treatment of exterior heat of the present invention has refrigeration function.
(4) antibacterial action experiment
Experiment material
Medicine: sample 25g, the solution being made into 1g/ml (with medical material) in water after 10 pounds of 115 DEG C of sterilizing 30min for.YINHUANG KOUFUYE, lot number: 990420,10ml/ props up, the Changjiang river, Wuhan City pharmaceutical factory product, bacterial strain: staphylococcus aureus, escherichia coli, Bacillus proteus, beta hemolytic streptococcus, provide by Yunnan Province's mat woven of fine bamboo strips one the People's Hospital Bacteriology Room.Each bacterium gets a platinum ear transferred species in 10ml thioglycollate solution medium by plate, and cultivate 18h for 37 DEG C, after taking out, front four kinds of bacterium are diluted to 10 with sodium chloride injection -4for, rear three kinds of bacterium are diluted to 10 with sodium chloride injection -2for.Thioglycollate solution medium, lot number: 990619,250g/ bottle, Jiangsu Province's Yixing City ten thousand stone culture medium factory product.
Experimental technique and result
Get sterilizing test tubes some, the first pipe adds sample medicinal liquid 20ml, therefrom takes out 10ml and adds (pipe is built with the culture medium of 10mL) in the 2nd pipe.Repeat operation and make medicinal liquid be diluted as 1:2,1:4,1:8 successively ... 1:128.With method dilution YINHUANG KOUFUYE.Get some, the test tube that 8|.9ml culture medium is housed, after often pipe adds different dilution factor medicinal liquid 1ml, often pipe adds bacterium liquid 0.1ml.Sample medicinal liquid and YINHUANG KOUFUYE all establish negative control pipe (not adding bacterium liquid), and each bacterium all establishes positive control pipe (not adding medicinal liquid).After application of sample, test tube is put 37 DEG C and cultivate 24h, observe long bacterium situation.The results are shown in Table 4.
The antibacterial action of the Chinese medicine composition of table 4 treatment exterior heat of the present invention
Note: " one " asepsis growth, "+" has bacteria growing
Result shows, the Chinese medicine composition for the treatment of exterior heat of the present invention is in different dilution factor to staphylococcus aureus (being namely called for short golden Portugal in table), escherichia coli (being namely called for short large intestine in table), and Bacillus proteus (being namely called for short distortion in table), bacillus pyocyaneus (being namely called for short green pus in table), streptococcus pneumoniae (being namely called for short pneumonia in table), α-hemolytic streptococcus (being namely called for short first chain in table), beta hemolytic streptococcus (being namely called for short second chain in table) have antibacterial action.
(5) antibacterium detoxifying function experiment
Experiment material
Medicine: sample 25g, the solution being made into lg/ml (with medical material) in water for.The malicious Cheongju sheet of heat, lot number: 2000561, every sheet is equivalent to crude drug 0.422g, Yunnan Paiyao Group Corp., Ltd's product, adds decocting in water 30min after porphyrize, cross leaching supernatant in 60 DEG C be concentrated into lg/ml (in medical material) concentration for.
Reagent: tachypleus amebocyte lysate, lot number: 000717, λ is that 0.25EU/ml, 0.1ml/ prop up, Zhanjiang HaiYang Biology products Factory product, apirogen water, lot number: 00087,5ml/ props up, Zhanjiang HaiYang Biology products Factory product; Bacterial endotoxin national standard, lot number: 981,9000EU/ props up, is provided by Nat'l Pharmaceutical & Biological Products Control Institute.
Experimental technique and result
Sample thief medicinal liquid (1g/ml) and Re Du Cheongju sheet medicinal liquid (1g/ml) make serial doubling dilution by apirogen water in apyrogeneity test tube.Getting that bacterial endotoxin national standard apirogen water dissolves and be diluted to final concentration is lEU/ml.Endotoxin diluent (lEU/ml) 0.05ml is added in 0.1ml tachypleus amebocyte lysate solution, add variable concentrations medicinal liquid 0.05ml again, get 0.1ml tachypleus amebocyte lysate solution to add apirogen water 0.05ml and add endotoxin diluent 0.05ml again and make positive control, get tachypleus amebocyte lysate solution 0.1ml and add apirogen water 0.1ml and make negative control.Each concentration liquid all establishes two reaction tubes.After application of sample, shake up, put 37 ± 0.5 DEG C and water-solublely hatch 60min, reaction tube is got gently from water-bath, slowly fall turnback, with in managing in strong gels person for positive reaction (+), though complete person can not be kept for negative reaction (-) in gel or in gel gel in pipe.The results are shown in Table 5.
The antibacterium detoxifying function of the Chinese medicine composition of table 5 treatment exterior heat of the present invention
Result shows, the Traditional Chinese medicine composition liquid medicine (lg/ml) for the treatment of exterior heat of the present invention and 1/2,1/4,1/8,1/16 diluent thereof all can the gel reactions of anti-bacteria endotoxin and tachypleus amebocyte lysate, show that the Chinese medicine composition for the treatment of exterior heat of the present invention can reduce bacteriotoxic virulence, there is Detoxication.
Application examples
For fully showing the therapeutic effect of the Chinese medicine composition for the treatment of exterior heat of the present invention to the especially high hot patient of fever patient, show effect of its relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, heat-clearing and toxic substances removing, and observe its toxic and side effects and take safety, have selected medical history, the state of an illness, age, patient that sex is suitable, embodiment 1, embodiment 2, embodiment 3, embodiment 4 and embodiment 5 couples of patients are adopted to carry out therapeutic test respectively, instructions of taking is: oral, three times on the one, a 5g; Through more than 200 routine system clinical observations, evident in efficacy.120 examples below by way of the traditional Chinese medicine particle taking the treatment exterior heat of the present invention of embodiment 5 gained are described, but application of the present invention is not limited thereto.
One, study subject basic document
1, basic composition: treatment group is totally 120 examples, man 73 example, female 47 example, 19 years old ~ 63 years old age, average 39 years old, protopathy was upper respiratory tract infection 41 example, tonsillitis 32 example, acute pharyngitis 23 example, acute bronchitis 13 example, parotitis 7 example, simple pneumonia 4 example. the course of disease is the shortest 1 day, the longest 7 days.
2, symptom and sign: Symptoms is fever without perspiration 94 example, headache 46 example, limb aching pain 82 example, laryngopharynx swelling and pain 67 example, yellow 31 examples of cough expectorant, tetany 5 example, epistaxis 4 example, pulse condition is characterized as floating pulse or floating number, and tongue is changed to red tongue or limit point is red, the micro-Huang of white and thin fur.
3, lab testing: whole 120 routine patients do blood, urine, feces routine test inspection, and the heart, Liver and kidney function inspection.120 routine patient's routine blood test leukocyte raise in various degree.
Two, study subject is selected
(1) tcm diagnosis, CM syndrome differentiation criterion and foundation thereof
1, tcm diagnosis standard
(1) febris acuta, body temperature is up to more than 39 DEG C, and diurnal thermal can have fluctuation.
(2) be the evil poison morbidities of diseases caused by exogenous pathogenic factor.
(3) can with aversion to cold or shiver with cold, thirsty or feeling thirst but no desire to drink, is tired of Sao or raves dusk, constipation due to dry stool, red tongue, yellow fur, rapid pulse.
(4) lab testing: corresponding physico-chemical examination should be carried out according to different diseases, to consider etiological diagnosis.
2, Chinese medical discrimination
Wind-heat syndrome
Fever of the body is work comparatively, micro evil wind, sweating is not smooth, and distending pain in the head coughs ouch, and expectorant is sticky or yellow, parched throat, or red swelling and pain of throat, the turbid tears of nasal obstruction , Liu Yellow, thirst with desire to drink, tongue tip side of red, the micro-Huang of thin white fur of tongue, floating and rapid pulse.
3, severity Scaling:
Slight: body temperature reaches 39-39.4 DEG C, General Symptoms Zhi is micro-;
Moderate: body temperature reaches 39.5-39.9 DEG C, General Symptoms is remarkable;
Severe: body temperature reaches more than 40 DEG C, occurs that convulsion is fainted and closes de-danger disease.
(2) case standard is tested
1, include case standard in and meet above tcm diagnosis standard and differential diagnosis in tcm person, observation case can be included in.
2, Excluded cases standard
(1) applied antibiotic or other Western medicine person, according to circumstances got rid of.
(2) fever due to internal injury person.
(3) the severe primary diseases such as cardiovascular, cerebrovascular, liver, kidney hemopoietic system are merged, psychotic.
(4) age is under-18s or over-65s person, gestation or women breast-feeding their children, allergic constitution and those who are allergic to this drug.
(5) do not meet inclusive criteria, not by regulation medication, cannot curative effect be judged, or data is not congruent affects the treatment or safety judgement person.
Three, experimental technique
Accept to observe being in hospital or out-patient's totally 120 examples for the treatment of, all adopt the traditional Chinese medicine particle for the treatment of exterior heat of the present invention to control.Once a bag (every bag of 5g), one day three times, 7 days is a course for the treatment of, during Ureteral Calculus, within every two hours, surveys body temperature once, observes and start fever time and effectively hold time.
Four, experimental result
(1), curative effect determinate standard
1, clinic control: treat in 24 hours, temperature recovery is normal, and nothing is repeatedly, and cardinal symptom is clearly better.
2, effective: treat in 24 hours, body temperature reduces by more than 1.5 DEG C, and cardinal symptom alleviates.
3, effective: treat in 24 hours, body temperature reduction 0.5-1.5 DEG C, cardinal symptom has and alleviates.
4, invalid: to treat in 24 hours, body temperature reduces less than 0.5 DEG C, and symptom is not improved.
(2) efficacy analysis
After terminating the course for the treatment of, clinic control 42 example, effective 51 examples, effective 16 examples, invalid 11 examples, total effective rate is 90.8%.
The hot patient of general height, body temperature reaches person between 39-40 DEG C, and take in the traditional Chinese medicine particle 24 hours for the treatment of exterior heat of the present invention, namely body temperature obviously decline, and recovers normal.After terminating the course for the treatment of, body temperature maintains normal range.Patient with all symptoms such as sleepy, the headache of limbs, pharyngalgia, cough all obviously improve.
(3) analysis of adverse reactions
Follow up a case by regular visits to after period in a medicine and drug withdrawal, be showed no patient and untoward reaction occurs.
The Chinese medicine composition for the treatment of exterior heat of the present invention has relieving the exterior syndrome with drugs of pungent in flavor and cool in nature, effect of heat-clearing and toxic substances removing, use safety, be easy to carry, administrated method is simple, economical and practical, easily accepted by most of patients, it is the medicine of desirable treatment exterior heat, especially catch a cold, upper respiratory tract infection, tonsillitis, acute pharyngitis, acute bronchitis, simple pneumonia, the ideal medicament of the treatment of the caused high heat of the diseases such as parotitis, effect of bringing down a fever is very remarkable, shown by clinical verification, general heating patient medication 1 ~ 2 day, effect that heat moves back cool skin can be received, and control repeatly and imitate repeatly, effective percentage is up to 90.8%, bring down a fever fast efficient.
The invention is not restricted to above-mentioned embodiment, those skilled in the art make to any apparent improvement of above-mentioned embodiment or change, all can not exceed the protection domain of design of the present invention and claims.

Claims (10)

1. treat a Chinese medicine composition for exterior heat, it is characterized in that, containing following raw material: Cudrania tricuspidata (Carr.) Bur.ex Lavallia, Rhizoma Et Radix Baphicacanthis Cusiae, Gypsum Fibrosum, Flos Lonicerae, Radix Bupleuri, Radix Scutellariae, Radix Glycyrrhizae.
2. the Chinese medicine composition for the treatment of exterior heat according to claim 1, it is characterized in that, the weight of described each raw material dosage is as follows: Cudrania tricuspidata (Carr.) Bur.ex Lavallia 400 ~ 600 parts, Rhizoma Et Radix Baphicacanthis Cusiae 200 ~ 300 parts, 250 ~ 400 parts, Gypsum Fibrosum, Flos Lonicerae 160 ~ 240 parts, Radix Bupleuri 130 ~ 170 parts, Radix Scutellariae 130 ~ 170 parts, 40 ~ 60 parts, Radix Glycyrrhizae.
3. the Chinese medicine composition for the treatment of exterior heat according to claim 1, it is characterized in that, the weight of described each raw material dosage is as follows: Cudrania tricuspidata (Carr.) Bur.ex Lavallia 500 parts, Rhizoma Et Radix Baphicacanthis Cusiae 250 parts, 333 parts, Gypsum Fibrosum, Flos Lonicerae 200 parts, Radix Bupleuri 167 parts, Radix Scutellariae 167 parts, 50 parts, Radix Glycyrrhizae.
4. the Chinese medicine composition for the treatment of exterior heat according to claim 1, is characterized in that, the extract containing all or part of described raw material, and described extract is ethanol extraction or water extract.
5. the Chinese medicine composition of the treatment exterior heat according to any one of Claims 1-4, is characterized in that, the dosage form of the Chinese medicine composition of described treatment exterior heat is granule, tablet, capsule, decoction, unguentum, pill, mixture, syrup.
6. the Chinese medicine composition of the treatment exterior heat according to any one of Claims 1-4, is characterized in that, the dosage form of the Chinese medicine composition of described treatment exterior heat is granule.
7. a preparation method for the Chinese medicine composition of the treatment exterior heat described in any one of claim 1 to 6, is characterized in that, comprise the steps:
(1) Cudrania tricuspidata (Carr.) Bur.ex Lavallia, Rhizoma Et Radix Baphicacanthis Cusiae, Gypsum Fibrosum, Flos Lonicerae, Radix Bupleuri, Radix Scutellariae, Radix Glycyrrhizae is taken according to the proportioning raw materials of the Chinese medicine composition of the treatment exterior heat according to any one of claim 1 to 6, each raw material is pulverized respectively, obtains Cudrania tricuspidata (Carr.) Bur.ex Lavallia powder, Rhizoma Et Radix Baphicacanthis Cusiae powder, Gypsum Fibrosum powder, Flos Lonicerae powder, Radix Bupleuri powder, Radix Scutellariae powder and Radix Glycyrrhizae powder;
(2) in the Rhizoma Et Radix Baphicacanthis Cusiae powder of gained in step (1), add ethanol, carry out heating and refluxing extraction, then filter, gained filtrate and medicinal residues retain for subsequent use respectively;
(3) the Cudrania tricuspidata (Carr.) Bur.ex Lavallia powder of the medicinal residues of step (2) gained and step (1) gained, Gypsum Fibrosum powder, Flos Lonicerae powder, Radix Bupleuri powder, Radix Scutellariae powder and Radix Glycyrrhizae powder are mixed, decoct with water, then filter, retain filtrate stand-by;
(4) by step (3) gained filtrate heating simmer down to clear paste, then, gained clear paste is cooled to room temperature;
(5) in the clear paste of the rear gained of step (4) cooling, add ethanol, then mix homogeneously with the filtrate of step (2) gained, leave standstill, filter, after being reclaimed by the ethanol in gained filtrate, the Chinese medicine composition of exterior heat must be treated.
8. the preparation method of the Chinese medicine composition for the treatment of exterior heat according to claim 7, is characterized in that, also comprises the steps: after carrying out described step (5)
(6) after being reclaimed by step (5) ethanol, the remaining liquid concentration of institute is thick paste;
(7) in step (6) gained thick paste, add filler, correctives, mixing, makes granule, drier, obtains the Chinese medicine composition of the treatment exterior heat of bead dosage form.
9. the preparation method of the Chinese medicine composition for the treatment of exterior heat according to claim 8, is characterized in that, described filler is one or more the combination in lactose, mannitol, dextrin and soluble starch;
Described correctives is that steviosin, aspartame, protein sugar, Ansai are close, a kind of in xylitol or fructose or or two or more combination.
10. the purposes of Chinese medicine composition in the medicine of preparation treatment cold, fever, upper respiratory tract infection heating, laryngopharynx swelling and pain heating, tonsillitis heating, parotitis heating, acute pharyngitis heating, acute bronchitis heating, simple pneumonia heating of the treatment exterior heat described in any one of claim 1 to 6.
CN201410693647.7A 2014-11-25 2014-11-25 Traditional Chinese medicine composition for treatment of exterior heat and preparation method thereof Pending CN104474021A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201410693647.7A CN104474021A (en) 2014-11-25 2014-11-25 Traditional Chinese medicine composition for treatment of exterior heat and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201410693647.7A CN104474021A (en) 2014-11-25 2014-11-25 Traditional Chinese medicine composition for treatment of exterior heat and preparation method thereof

Publications (1)

Publication Number Publication Date
CN104474021A true CN104474021A (en) 2015-04-01

Family

ID=52748723

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201410693647.7A Pending CN104474021A (en) 2014-11-25 2014-11-25 Traditional Chinese medicine composition for treatment of exterior heat and preparation method thereof

Country Status (1)

Country Link
CN (1) CN104474021A (en)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104922273A (en) * 2015-07-03 2015-09-23 梧州市景泰养鳖专业合作社 Chinese herbal preparation for treating Chinese softshell turtle parotitis and preparing method thereof
CN104940383A (en) * 2015-07-03 2015-09-30 梧州市景泰养鳖专业合作社 Chinese herba preparation for treating Chinese softshell turtle parotitis and preparation method thereof
CN105147849A (en) * 2015-10-21 2015-12-16 罗盈 Oral liquid for treating amygdalitis

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101829231A (en) * 2010-04-29 2010-09-15 范平安 Medicament for treating hyperpyrexia

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101829231A (en) * 2010-04-29 2010-09-15 范平安 Medicament for treating hyperpyrexia

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
中华人民共和国药典委员会: "《国家药品中药标准(内科 肺系(一)分册)》", 31 December 2002 *
阎玉凝等: "《中药材概论》", 28 February 2009, 中国中医药出版社 *

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104922273A (en) * 2015-07-03 2015-09-23 梧州市景泰养鳖专业合作社 Chinese herbal preparation for treating Chinese softshell turtle parotitis and preparing method thereof
CN104940383A (en) * 2015-07-03 2015-09-30 梧州市景泰养鳖专业合作社 Chinese herba preparation for treating Chinese softshell turtle parotitis and preparation method thereof
CN104922273B (en) * 2015-07-03 2017-12-22 梧州市景泰养鳖专业合作社 Treat Chinese medicine preparation of Shelled Turtle Trionyx Sinensis parotitis and preparation method thereof
CN104940383B (en) * 2015-07-03 2017-12-22 梧州市景泰养鳖专业合作社 A kind of Chinese medicine preparation for treating Shelled Turtle Trionyx Sinensis parotitis and preparation method thereof
CN105147849A (en) * 2015-10-21 2015-12-16 罗盈 Oral liquid for treating amygdalitis

Similar Documents

Publication Publication Date Title
CN103585433B (en) Traditional Chinese medicine composition for treating oral ulcer
CN103768308B (en) A kind of pharmaceutical composition that is used for the treatment of the infection of the upper respiratory tract and preparation method thereof
CN102940719A (en) Chinese herbal medicine feed additive for treating dairy cow mastitis
CN105560372A (en) Traditional Chinese medicine spray for treating rhinitis and preparation method thereof
CN103800772A (en) Gynecological external lotion for preventing and treating vagina inflammatory diseases and preparation method thereof
CN103251844B (en) For the tablet of cleaning throat and moistening larynx
CN101628108B (en) Traditional Chinese medicinal granules for treating wind-cold evil and preparation method thereof
CN104474021A (en) Traditional Chinese medicine composition for treatment of exterior heat and preparation method thereof
CN103961614B (en) Chinese medicine composition for treating respiratory disease and its production and use
CN100367994C (en) Medicinal preparation for treating deaf and preparing method
CN103071134B (en) External preparation for treating rheumatic arthrodynia and traumatic pain and swelling and preparation method thereof
CN104489265A (en) Compound feed for treatment of moist fowl pox and preparation method thereof
CN105362337B (en) A kind of Chinese medicine composition with heat-clearing dissipating bind function, preparation and preparation method thereof
CN103816281B (en) A kind of Chinese medicine composition of prevention and treatment anemopyretic cold
CN104983968A (en) Pyretolysis traditional Chinese medicine composition and preparation method
CN102335373A (en) Chinese medicinal composition for treating upper respiratory tract infection, and preparation method thereof
CN1686424B (en) Medicinal composition containing scutellaria and bupleurum and its preparation method
CN105381310A (en) Traditional Chinese medicine preparation for treating phthisis and preparing method thereof
CN113577187B (en) Traditional Chinese medicine composition and traditional Chinese medicine extract for treating influenza and preparation method and application thereof
CN1919270B (en) Composition, exract, and pharmaceutical use thereof
CN104825852B (en) A kind of Tibetan medicinal composition and its preparation method and application
CN103251845B (en) For the compositions of cleaning throat and moistening larynx
CN102784364B (en) Pure traditional Chinese medicine powder for preventing and treating chicken colibacillosis and preparation method of pure traditional Chinese medicine powder
CN103181972A (en) Tablet or capsule of traditional Chinese medicine for treating wind-heat type common cold and upper respiratory infection, and preparation method thereof
CN108498655B (en) Lanjin oral liquid for clearing heat and removing toxicity and preparation method thereof

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
RJ01 Rejection of invention patent application after publication
RJ01 Rejection of invention patent application after publication

Application publication date: 20150401