CN105998599A - Traditional Chinese medicine composition for treating viral respiratory tract infection and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treating viral respiratory tract infection and preparation method thereof Download PDF

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CN105998599A
CN105998599A CN201610277907.1A CN201610277907A CN105998599A CN 105998599 A CN105998599 A CN 105998599A CN 201610277907 A CN201610277907 A CN 201610277907A CN 105998599 A CN105998599 A CN 105998599A
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virus
chinese medicine
medicine composition
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曲敬来
陈生
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Shenzhen Traditional Chinese Medicine Hospital
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/17Gnetophyta, e.g. Ephedraceae (Mormon-tea family)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06Fungi, e.g. yeasts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
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    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
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    • 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)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • 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)
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    • 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
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    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/488Pueraria (kudzu)
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    • 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
    • A61K36/535Perilla (beefsteak plant)
    • AHUMAN NECESSITIES
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    • 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
    • A61K36/538Schizonepeta
    • AHUMAN NECESSITIES
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    • 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
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736Prunus, e.g. plum, cherry, peach, apricot or almond
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    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8964Anemarrhena
    • AHUMAN NECESSITIES
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    • 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)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8966Fritillaria, e.g. checker lily or mission bells

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Abstract

The invention discloses a traditional Chinese medicine composition for treating viral respiratory tract infection and a preparation method thereof. The composition comprises the following raw medicinal materials in parts by weight: 3-20 parts of honey-fried ephedra, 3-20 parts of flos farfarae, 5-25 parts of schizonepeta spike, 5-20 parts of radix asteris, 5-15 parts of apricot kernel, 5-20 parts of roasted perilla seed, 3-15 parts of rhizoma anemarrhenae, 3-15 parts of bulbus fritillariae thunbergii, 5-25 parts of fructus arctii, and 2-15 parts of liquorice. The raw medicinal materials are matched with auxiliary materials and a flavoring agent to be directly or indirectly made into pharmaceutically acceptable capsules, oral liquid, granules, syrup, tablets, effervescent particles, dropping pills, aerosol, spraying agent, gargle, mouthwash and a variety of dosage forms via conventional processes. The traditional Chinese medicine composition can be clinically used for treating or preventing the respiratory tract viral infectious diseases caused by influenza A virus, influenza B virus, rhino virus, coronavirus, respiratory syncytial virus, hand, foot and mouth virus, adenovirus, parainfluenza virus, echovirus, coxsackievirus and the like.

Description

A kind of Chinese medicine composition treating viral respiratory tract infection and preparation method thereof
Technical field
The invention belongs to technical field of Chinese medicines, be a kind of about treatment viral respiratory tract infection, particularly below treatment Respiratory viral infection disease is main Chinese medicine composition and preparation method thereof.Wherein, described respiratory virus infection is Refer to influenza A virus, Influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, hand-foot-mouth disease virus, adenovirus, The respiratory virus infection that parainfluenza virus, echovirus, Coxsackie virus etc. are caused.
Background technology
Human respiratory tract is the door of an opening, and extraneous virus easily enters human body by respiratory tract, causes respiratory system Infecting, relevant investigation display, the ratio that the respiratory tract infection caused after virus attack human body occurs greatly exceeds antibacterial sense The ratio of the respiratory infectious disease that dye human body causes.Virus has had stronger infectiousness mostly, and onset is hurried, passes Broadcast rapidly, it is easy to the change of disease, there is higher morbidity risk rate and death rate.Respiratory tract infection includes upper respiratory tract infection, trachea Inflammation, bronchitis and bronchopneumonia.The pathogen of lower respiratory infection is various virus and antibacterial.Weak, allergy and slow Property sinusitis person is often susceptible to suffer from primary disease, the especially more easy infection when climate change, air pollution environmental.During lower respiratory channel virus infection In addition to having upper respiratory tract infection symptoms, cough is many in dryness in early days, transfers moist cough in the later stage. and also have some patients companion to breathe heavily The symptoms such as ring, respiratory rhythm speed, appetite drowsiness, spiritual difference, lower respiratory channel virus infection disease sickness rate in recent years has The trend increased, as shown according to etiologic research, viral pneumonia accounts for the 18% of community acquired pneumonia, in hospital's same period Interior Acquired Infection accounts for 5%, especially in the AIDS VICTIMS infecting HIV (human immunodeficiency virus) (HIV) when cause, its Sickness rate the most drastically raises, and is more and more paid close attention to by people.Thus how can cure Respirovirus efficiently and effectively Infectious disease is particularly important.
The common virus of respiratory tract infection has influenza A virus, Influenza B virus, rhinovirus, coronavirus, breathing Road syncytial virus, hand-foot-mouth disease virus, adenovirus, parainfluenza virus, echovirus, Coxsackie virus etc..Acute viral laryngitis How to be caused by influenza A virus, Influenza B virus, rhinovirus, parainfluenza virus and adenovirus etc., Clinical symptoms be hoarseness, Pain when difficulty speaking, cough, often has heating, pharyngitis or cough, and laryngeal edema, hyperemia seen from health check-up, regional nodes is slight Enlargement and tenderness, audible and whoop;Acute viral bronchitis is many by rhinovirus, influenza A virus, influenza B disease Poison, parainfluenza virus, respiratory syncytial virus, adenovirus etc. cause, and clinical manifestation is cough, is mucus without expectorant or expectorant, companion There is heating with weak, uncomfortable in chest.Other symptoms often have pain under hoarseness, non-pleura breastbone, audible and dryness or moist sound, X Line chest films showed blood vessel shade increases, strengthens, but apneumia infiltration shade;Influenza A virus, Influenza B virus or rhinovirus Property bronchitis often causes the acute attack of chronic bronchitis;Viral bronchiolitis is mainly drawn by respiratory syncytial virus Rising, typically occur in infant, performance cough, asthma, severe patient may occur in which cyanosis;Viral pneumonia is mainly sick by influenza A Poison, Influenza B virus, rhinovirus, parainfluenza virus, adenovirus and respiratory syncytial virus etc. cause.Performance heating, cough, QI rising in reverse order, tachypnea, flaring nares, severe one may occur in which that lip and fingernail are livid purple, pulmonary shadow seen from Chest X-rays.
Because the metabolic pathway that virus utilizes host cell replicates, so, in general, can be right if do not used Host cell produces the medicine of toxic action and is difficult to be eliminated.At present, domestic and international doctor trained in Western medicine is to the virus such as rhinovirus, coronavirus Infect many employing ribavirins to treat.Owing to rhinovirus serotype is many, and virus antigen constantly makes a variation, for each blood Clear type all works out corresponding vaccine to prevent this target of rhinovirus infection to be difficult to.To influenza A virus, second The prevention and controls of type influenza virus is exactly the generation using the pre-anti-virus of vaccine according to antigen-antibody theory, but due to virus Antigen constantly occurs to make a variation, and vaccine the most just loses effect.And for antiviral drug, variability based on virus and Problems such as the drug resistance of medicine, and antibiotic is invalid to virus, make virus to prevent and treat problem the severeest.
Respiratory viral infection disease belongs among " flu ", " cough ", " the syndrome of dyspnea " of the traditional Chinese medical science, " bronchial wheezing ", primary disease Many, the six climate exopathogens seasonal pathogen inappropriate at weather cataclysm, changes in temperature of generation vigorous when, or human righteousness's virtual loss, time easily by exopathogen.As " Plain Questions comments pyretography " is said: " being gathered of heresy, its gas must be empty ".If daily life is lacked of proper care, cold temperature is uncomfortable, or overstrain, all The human body flesh natural fibre line of meat can be made to loosen, and disharmony of nutrient QI with defensive QI, healthy energy virtual loss, weakened defensive QI, being invaded by exogenous pathogen i.e. susceptible disease theory of Chinese medical science thinks " lung Main gas, department breathes "." gas " mentioned here, on the one hand refers to the gas of breathing, on the one hand refers to that lung and other internal organs show and exhales Function in terms of suction." lung opening at nose and throat, outer conjunction fur "." Plain Questions. cough opinion " say: " and fur person, the conjunction of lung also, fur First by pathogen, pathogen is to close also from it ", say is that lung is communicated with the external world by nasopharynx part and skin hair key, just as one barrier, The defensive enginery of supervisor's human body.The paathogenic factor such as external wind, cold, summer-heat, wet, dry, fiery (being referred to as the heresy of six climate exopathogens) often through Nasopharynx part and fur, first invade in lung, causes lung qi to lose and sends out or during respectful fall in a surname, all can make abnormal rising of lung-QI and cause cough, Pant, the symptom such as expectoration, this belongs to exogenous cough.The heresy of six climate exopathogens is caused a disease, how based on ailment said due to cold or exposure, and winter many wind and cold, spring many wind heat, Xia Duo Heat-damp in summer, autumn many wind-dryness, plum rain season holds damp under the arm more.Rather than time gas when holding under the arm row virus hurt sb.'s feelings, then be often not limited to season, and The state of an illness is multiple, easily causes infection popular.And influenza, belong to the pathogenic wind-warm category of epidemic febrile disease, belong to influenza, its feature also positive capsule Having included the feature of diseases caused by exogenous pathogenic factor respiratory disease: seasonable, heating height, state of an illness weight, infection popularity is strong, scope is wide.
Chinese medicine not only has that drug resistance is low, side effect and the advantage such as untoward reaction is few, and also suppresses virus replication, tune Save immunologic function, improve the comprehensive effect such as blood circulation, antipyretic-antalgic and anti-inflammation, some antipyretic and antidotal type medium-height grass therein Medical instrument has the effect that induction human body internal interference element produces, such that it is able to suppression virus replication, the immunity of regulation human body, promotes lung The improvement of ventilatory function and microcirculatory improvement, can reach to alleviate the state of an illness of patient, shorten the course of disease, reduction mortality rate further Purpose.It has advantage and the vast potential for future development of uniqueness in terms of preventing and treating virus infection.Research shows, antipyretic and antidotal type Chinese medicine has many to have the effect of direct antiviral, such as Rhizoma Osmundae, Flos Lonicerae, Flos Chrysanthemi Indici, Folium Isatidis etc..
Summary of the invention
Therefore, the Chinese medicine preparation of people's treatment more preferable to curative effect viral respiratory tract infection still suffers from demand.So far it is Only, any report about pharmaceutical composition of the present invention is not the most found.The present inventor through repeatedly studying, and by external and The checking repeatedly of clinical trial, have found the Chinese medicine composition of the treatment viral respiratory tract infection of more preferable curative effect finally, from And complete the present invention.The present invention is directed to above-mentioned etiology and pathogenesis, use targetedly and there is the viral breathing of unique treatment The prepared from traditional Chinese medicines of road infection effect forms.Said composition is mainly by Herba ephedrae, Flos Farfarae, Herba Schizonepetae, Radix Asteris, Semen Armeniacae Amarum, stir-fry purple Fructus Perillae, the Rhizoma Anemarrhenae, Bulbus Fritillariae Thunbergii, Fructus Arctii, Radix Glycyrrhizae composition, there is wind and heat dispersing, the merit of smooth throat to stop cough, can be clinically used for treatment or Prevent by influenza A virus, Influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, hand-foot-mouth disease virus, gland The viral respiratory tract infection that virus, parainfluenza virus, echovirus, Coxsackie virus etc. are caused.
It is an object of the invention to: overcome the deficiencies in the prior art, it is provided that one can effectively be treated or prevent by A type stream Influenza Virus, Influenza B virus, rhinovirus, coronavirus, respiratory syncytial virus, adenovirus, parainfluenza virus, angstrom can be sick The Chinese medicine composition of the viral respiratory tract infection that poison, Coxsackie virus etc. are caused.
It is another object of the present invention to: provide the preparation method of this Chinese medicine composition, meet the demand in market.
For reaching more preferable curative effect, medicine of the present invention can combine with raw material Radix Bupleuri, Radix Scutellariae.
For reaching more preferable curative effect, medicine of the present invention can combine with raw material Semen Oroxyli, Lasiosphaera Seu Calvatia.
For reaching more preferable curative effect, medicine of the present invention can combine with raw material Radix Puerariae, Bulbus Fritillariae Cirrhosae.
The Chinese medicine composition for the treatment of respiratory viral infection disease, including the crude drug of following parts by weight: Herba ephedrae 3-20 part, Flos Farfarae 3-20 part, Herba Schizonepetae 5-25 part, Radix Asteris 5-20 part, Semen Armeniacae Amarum 5-15 part, Fructus Perillae (parched) 5-20 part, Rhizoma Anemarrhenae 3- 15 parts, Bulbus Fritillariae Thunbergii 3-15 part, Fructus Arctii 5-25 part, Radix Glycyrrhizae 2-15 part.
Wherein the consumption of crude drug is it may also is that Herba ephedrae 3-15 part, Flos Farfarae 5-15 part, Herba Schizonepetae 5-20 part, Radix Asteris 5-15 part, Semen Armeniacae Amarum 10-15 part, Fructus Perillae (parched) 5-15 part, Rhizoma Anemarrhenae 3-10 part, Bulbus Fritillariae Thunbergii 3-10 part, Fructus Arctii 5-20 part, Radix Glycyrrhizae 2- 10 parts.
Wherein crude drug also have: Radix Bupleuri 5-20 part, Radix Scutellariae 5-15 part,
Wherein crude drug also has: Semen Oroxyli 10-30 part, Lasiosphaera Seu Calvatia 10-20 part.
Wherein crude drug also has: Radix Puerariae 10-80 part, Bulbus Fritillariae Cirrhosae 5-20 part.
The technical solution adopted for the present invention to solve the technical problems is: the Chinese medicine composition for the treatment of viral respiratory tract infection Thing, including the crude drug of following parts by weight: Herba ephedrae 3-20 gram, Flos Farfarae 3-20 gram, Herba Schizonepetae 5-25 gram, Radix Asteris 5-20 Gram, 5-15 gram of Semen Armeniacae Amarum, Fructus Perillae (parched) 5-20 gram, Rhizoma Anemarrhenae 3-15 gram, Bulbus Fritillariae Thunbergii 3-15 gram, Fructus Arctii 5-25 gram, 2-15 gram of Radix Glycyrrhizae.
Preferable amount is: Herba ephedrae 3-15 gram, Flos Farfarae 5-15 gram, Herba Schizonepetae 5-20 gram, Radix Asteris 5-15 gram, Semen Armeniacae Amarum 10- 15 grams, Fructus Perillae (parched) 5-15 gram, Rhizoma Anemarrhenae 3-10 gram, Bulbus Fritillariae Thunbergii 3-10 gram, Fructus Arctii 5-20 gram, 2-10 gram of Radix Glycyrrhizae.
The preparation method of medicine of the present invention is as follows:
Take crude drug Herba ephedrae, Flos Farfarae, Herba Schizonepetae, Radix Asteris, Semen Armeniacae Amarum, Fructus Perillae (parched), the Rhizoma Anemarrhenae, Bulbus Fritillariae Thunbergii, Fructus Arctii, Radix Glycyrrhizae add Soak by water merging filtrate, concentrate, cool down, add ethanol and make alcohol content 20-80%, reclaim ethanol, make supernatant concentration become thick paste, standby With.The thick paste of preparation is added capsule and commonly uses adjuvant, be dried, pulverize loading capsule, can be prepared as treating viral breathing The capsule that road infects;Or thick paste is commonly used adjuvant with granule mix, pelletize, be dried and be distributed into bag, treatment can be prepared as The granule of viral respiratory tract infection;Or thick paste is commonly used adjuvant with oral liquid mix, boil, dilute, stand, mistake Filter, mixing is distributed into bottle, can be prepared as treating the oral liquid of viral respiratory tract infection;Or thick paste is added sucrose, taste masking Agent, preservative, boil, and is diluted with water to 1000ml, stands, and filters, mixing, and subpackage obtains treatment viral respiratory tract infection Syrup, wherein said sucrose weight > 450g, described correctives be stevioside, saccharin sodium, acesulfame-K, glycyrrhizin, ring Alkylamino sulfonic acid, agedoite, alcohol sugar, radix asparagi sweet extract, Mentholum, various essence and various fruity material, consumption is 0.1 ~ 10%, Described preservative be sorbic acid and k-na salt consumption be < 0.3%, methyl hydroxybenzoate class consumption be < 0.05%, described subpackage makes Packaging material be vial, plastic bottle;Maybe the thick paste of preparation is commonly used with tablet adjuvant mix, tabletting, can be prepared as treatment The tablet of viral respiratory tract infection.
If also combined with raw material Radix Bupleuri, Radix Scutellariae, its preparation method is:
Take crude drug Herba ephedrae, Flos Farfarae, Herba Schizonepetae, Radix Asteris, Semen Armeniacae Amarum, Fructus Perillae (parched), the Rhizoma Anemarrhenae, Bulbus Fritillariae Thunbergii, Fructus Arctii, Radix Glycyrrhizae, Radix Bupleuri, Radix Scutellariae boiling merging filtrate, concentrate, cool down, add ethanol and make alcohol content 20-80%, reclaim ethanol, make supernatant dense Shorten thick paste into, standby.The thick paste of preparation is added capsule and commonly uses adjuvant, be dried, pulverize loading capsule, treatment can be prepared as The capsule of viral respiratory tract infection;Or thick paste is commonly used adjuvant with granule mix, pelletize, be dried and be distributed into bag, It is prepared as treating the granule of viral respiratory tract infection;Or thick paste is commonly used adjuvant with oral liquid mix, boil, add water dilute Releasing, stand, filter, mixing is distributed into bottle, can be prepared as treating the oral liquid of viral respiratory tract infection;Or thick paste is added Sucrose, correctives, preservative, boil, and is diluted with water to 1000ml, stands, and filters, mixing, and subpackage must treat viral exhaling Inhaling the syrup that road infects, wherein said sucrose weight > 450g, described correctives is stevioside, saccharin sodium, acesulfame-K, glycyrrhizin Element, thiacyclohexane sulfamic acid, agedoite, alcohol sugar, radix asparagi sweet extract, Mentholum, various essence and various fruity material, consumption is 0.1 ~ 10%, described preservative be sorbic acid and k-na salt consumption be < 0.3%, methyl hydroxybenzoate class consumption be < 0.05%, institute The packaging material stating subpackage use is vial, plastic bottle;Maybe the thick paste of preparation is commonly used with tablet adjuvant mix, tabletting, can make The tablet of standby one-tenth treatment viral respiratory tract infection.
If also combined with raw material Semen Oroxyli, Lasiosphaera Seu Calvatia, its preparation method is:
Take crude drug Herba ephedrae, Flos Farfarae, Herba Schizonepetae, Radix Asteris, Semen Armeniacae Amarum, Fructus Perillae (parched), the Rhizoma Anemarrhenae, Bulbus Fritillariae Thunbergii, Fructus Arctii, Radix Glycyrrhizae, Radix Bupleuri, Radix Scutellariae, Semen Oroxyli, Lasiosphaera Seu Calvatia boiling merging filtrate, concentrate, cool down, add ethanol and make alcohol content 20-80%, reclaim second Alcohol, makes supernatant concentration become thick paste, standby.The thick paste of preparation is added capsule and commonly uses adjuvant, be dried, pulverize loading capsule, Can be prepared as treating the capsule of viral respiratory tract infection;Or thick paste commonly used adjuvant with granule mix, pelletize, be dried and It is distributed into bag, can be prepared as treating the granule of viral respiratory tract infection;Or thick paste is commonly used adjuvant with oral liquid mix, Boiling, dilute, stand, filter, mixing is distributed into bottle, can be prepared as treating the oral liquid of viral respiratory tract infection; Or thick paste is added sucrose, correctives, preservative, and boil, be diluted with water to 1000ml, stand, filter, mixing, subpackage, to obtain final product Treatment viral respiratory tract infection syrup, wherein said sucrose weight > 450g, described correctives be stevioside, saccharin sodium, Acesulfame-K, glycyrrhizin, thiacyclohexane sulfamic acid, agedoite, alcohol sugar, radix asparagi sweet extract, Mentholum, various essence and various fruit Taste substance, consumption is 0.1 ~ 10%, described preservative be sorbic acid and k-na salt consumption be < 0.3%, methyl hydroxybenzoate class consumption be < 0.05%, the packaging material that described subpackage uses is vial, plastic bottle;Maybe the thick paste of preparation is commonly used with tablet adjuvant mix, Tabletting, can be prepared as treating the tablet of viral respiratory tract infection.
If also combined with raw material Radix Puerariae, Bulbus Fritillariae Cirrhosae, its preparation method is:
Take crude drug Herba ephedrae, Flos Farfarae, Herba Schizonepetae, Radix Asteris, Semen Armeniacae Amarum, Fructus Perillae (parched), the Rhizoma Anemarrhenae, Bulbus Fritillariae Thunbergii, Fructus Arctii, Radix Glycyrrhizae, Radix Bupleuri, Radix Scutellariae, Semen Oroxyli, Lasiosphaera Seu Calvatia, Radix Puerariae, Bulbus Fritillariae Cirrhosae boiling merging filtrate, concentrate, cool down, add ethanol and make alcohol content 20- 80%, reclaim ethanol, make supernatant concentration become thick paste, standby.The thick paste of preparation is added capsule and commonly uses adjuvant, be dried, pulverize Load capsule, can be prepared as treating the capsule of viral respiratory tract infection;Or thick paste is commonly used adjuvant with granule mix, system Grain, is dried and is distributed into bag, can be prepared as treating the granule of viral respiratory tract infection;Or thick paste is commonly used with oral liquid Adjuvant mixes, and boils, dilute, stands, and filters, and mixing is distributed into bottle, can be prepared as treating viral respiratory tract infection Oral liquid;Or thick paste is added sucrose, correctives, preservative, and boil, be diluted with water to 1000ml, stand, filter, mixing, Subpackage, must treat the syrup of viral respiratory tract infection, wherein said sucrose weight > 450g, and described correctives is Flos Chrysanthemi Glycosides, saccharin sodium, acesulfame-K, glycyrrhizin, thiacyclohexane sulfamic acid, agedoite, alcohol sugar, radix asparagi sweet extract, Mentholum, various perfume (or spice) Smart and various fruity material, consumption is 0.1 ~ 10%, described preservative be sorbic acid and k-na salt consumption be < 0.3%, oxybenzene first Esters consumption is < 0.05%, and the packaging material that described subpackage uses is vial, plastic bottle;Maybe the thick paste of preparation is commonly used with tablet Adjuvant mixing, tabletting, can be prepared as treating the tablet of viral respiratory tract infection.
Chinese medicine composition of the present invention can be prepared as dosage form described on any pharmaceutics: capsule, oral liquid, granule Agent, syrup, tablet, effervescent granule, drop pill, aerosol, spray, gargarisma, collutory;Wherein said tablet be oral cavity disintegration tablet, Effervescent tablet.
Medicament selection Herba ephedrae of the present invention, Flos Farfarae, Herba Schizonepetae, Radix Asteris, Semen Armeniacae Amarum, the Fructus Perillae (parched) Rhizoma Anemarrhenae, Bulbus Fritillariae Thunbergii, Fructus Arctii Son, Radix Glycyrrhizae are combined.These drug regimens make each efficacy of drugs produce synergism such that it is able to effectively treat breathing Road disease of viral infection.Its epheday intermedia nature and flavor hardship pungent, micro-, temperature, have the effect induced sweat, relieving asthma.See " legendary god of farming's book on Chinese herbal medicine the earliest Warp ", record its effect for " main apoplexy, cold headache, pyrexial malaria, deliver perspiration, and uncharm steam, only cough with dyspnea, except cold and heat, broken Accumulation." " book on Chinese herbal medicine justice " say: " Herba Ephedrae the gentliest floats, and specially dredges lung strongly fragrant, leading mechanism of qi off, being for controlling diseases caused by exogenous pathogenic factor the first key medicine, though saying solution Table, actually opens lung, though saying cold expelling, actually lets out heresy, and wind and cold solid dissipate outward, i.e. warm also without good logical with a surname." Rhizoma Anemarrhenae is clear Purte the white, nourshing Yin and drynsessmoistening prescription, " Japan hanako materia medica ": " logical small intestinal, expectorant antitussive, moisten cardiopulmonary, and qi-restoratives is weary, and spasmolytic of feeling at ease is throbbed with fear." two medicines Share, both declared scattered the lung being invaded by pathogenetic wind heat, hot and suffocating in lung heat clearing again, it is monarch drug altogether.Rhizoma Anemarrhenae dose times Herba Ephedrae, makes and use mutually, makes full side partially In pungent cool, Herba Ephedrae obtains the Rhizoma Anemarrhenae, depressed lung-energy dispersing and do not help heat, the Rhizoma Anemarrhenae obtains Herba Ephedrae, removing summer-heat lung-heat and the coolest hold back.Herba Schizonepetae is pungent, tepor is returned Lung, Liver Channel, have effect of induce sweat scattered wind, rash;Helping Herba Ephedrae a surname and send out lung qi, expelling pathogenic factors from the exterior is gone out.Semen Armeniacae Amarum bitter in the mouth, drops profit lung qi and puts down Breathe heavily;Matching with Herba Ephedrae then declares fall suitable, Bulbus Fritillariae Thunbergii removing heat from the lung and dissipating phlegm cough-relieving;Share with the Rhizoma Anemarrhenae and play clearing away lung-heat and moistening for dryness altogether, preventing phlegm from forming and stopping coughing it Effect.Three dissipates pathogenic factor in the exterior, clearing and antitussive for ministerial drug principal drug assistance a surname altogether.The pungent Wen Errun of Fructus Perillae, its main fall of property, it is longer than fall lung qi and disappears Expectorant, stops up the key medicine of QI rising in reverse order fullness in the chest, and arrogates to oneself loosening bowel to relieve constipation, make intestinal internal organs unobstructed and help the respectful fall of lung for treatment expectorant, and " herbal classic meets source " is called It " is except diprophylline is coughed, pleasant good dose of expectorant." Radix Asteris bitter in the mouth and gentle, have the therapeutic method to keep the adverse QI flowing downwards to reduce phlegm, reason lung antitussive merit;Acrid in the mouth, sweet, Bitter, warm, there is effect of moistening the lung and resolving phlegm cough-relieving.Modern pharmacological research result shows, histamine and acetic acid choline are caused by Radix Asteris Guinea pig trachea is shunk significant inhibitory action., when Radix Asteris mass concentration is for the moment, and the guinea pig trachea causing histamine is shunk to be had Substantially suppression, acts on other research and also finds, is remarkably improved its cough and asthma relieving efficacy when Radix Asteris and Radix Glycyrrhizae compatibility.Flos Farfarae is moistened Lung cough-relieving, share with Radix Asteris, helps preventing phlegm from forming and stopping coughing.Fructus Arctii is pungent, bitter, cold in nature, attaches to the lung and stomach meridians, and dispelling wind and heat pathogens, heat-clearing and toxic substances removing are saturating Rash, lung qi dispersing sore-throat relieving dissipate swollen;Four is adjuvant drug altogether, principal drug assistance reducing heat and dispersing lung-QI, smooth throat to stop cough.The raw use of Radix Glycyrrhizae, coordinating the actions of various ingredients in a prescription, and can stop Cough, hold concurrently and make for assistant.All medicine compatibilities, outer dispersing wind and cold, interior clearing away phlegm heat, dispersing and lowering lung-QI, make lung-heat clear, exopathogen dissipates, and inverse gas drops, expectorant turbidity And cough with asthma must be put down.
For the curative effect reached, medicine of the present invention also combines with Radix Bupleuri, Radix Scutellariae.This is because Radix Scutellariae is bitter, cold, return lung, Gallbladder, spleen, large intestine, small intestine meridian;Function heat clearing and damp drying, eliminating fire and detoxication, it is good at lung heat clearing stomach gallbladder and damp-heat in the large intestine, is especially longer than the clear middle part of the body cavity above the diaphragm housing the heart and lungs Damp and hot.Master enters lung meridian, is apt to clear purte the white and part of the body cavity above the diaphragm housing the heart and lungs excess-heat, thick with the cough expectorant controlled caused by lung-heat heap soil or fertilizer over and around the roots Sheng;Radix Bupleuri reducing fever by reconciliation, Rise and lift yang-energy, with Radix Scutellariae share one liter one clear, jointly discongest the heresy of part of the body cavity above the diaphragm housing the heart and lungs wind heat.
For the curative effect reached, medicine of the present invention also combines with Semen Oroxyli, Lasiosphaera Seu Calvatia.This is because Semen Oroxyli: cool in nature, return Lung, stomach, Liver Channel.Function removing heat from the lung and relieving sorethroat, dispersing the stagnated liver-QI for regulating the stomach, there is clearing away lung-heat, effect of throat, for controlling the key medicine of laryngopharynx swelling and pain, There is again the merit of removing heat from the lung and dissipating phlegm cough-relieving, be usually used in treating cough due to lung-heat;Lasiosphaera Seu Calvatia is pungent, flat, enters lung meridian, function: removing heat from the lung and relieving sorethroat, solves Poison, hemostasis.Controlling sore throat pharyngalgia, cough with aphonia, spit blood, epistaxis, traumatic hemorrhage, compatibility Fructus Arctii can dissipate wind and heat in the lung meridian and sore-throat relieving stops Cough;
In order to reach more preferable curative effect, medicine of the present invention also combines with Radix Puerariae, Bulbus Fritillariae Cirrhosae.This is because Radix Puerariae energy expelling pathogenic factors from muscles for reducing heat, Promote the production of body fluid, rash, yang invigorating antidiarrheal." book on Chinese herbal medicine justice ": " Radix Puerariae, use this person, cool scattered with it, though all yang channels of Starch 1500, and positive bright be, Light with its gas, therefore kind relieving the exterior syndrome by diaphoresis.How hot the medicine of all dismission is, and this is the coolest and sweet, therefore row epidemic when solving warm, Fan Re and hold concurrently thirsty Person, this is the best." Folium Perillae, Herba Schizonepetae expelling pathogenic factors from muscles can be assisted to deliver, dispelling wind pathogens.Bulbus Fritillariae Cirrhosae has nourishing the lung to arrest cough resolving phlegm and relieving asthma, clearly Effect of transconversion into heat expectorant, experimentation shows that Bulbus Fritillariae Cirrhosae has antitussive, phlegm-dispelling functions.Employing ammonia induced cough in mice is tested, tissue Cultivating Bulbus Fritillariae Cirrhosae and wild Bulbus Fritillariae Cirrhosae, 3.0g/kg gavage, when 30 minutes, antitussive effect is the strongest, and cough-relieving rate is more than 50%, uses mice phenol Red excretion method is tested, and family plants and wild Bulbus Fritillariae Cirrhosae 200% fluid extract 25ml/kg, Bulbus Fritillariae Cirrhosae alkaloid 11.3mg/kg and Bulbus Fritillariae Uninbracteatae soap Glycoside I~No. III 0.5mg/kg, all have more apparent expectorant effect.
Chinese medicine composition of the present invention is summed up in traditional Chinese medical science antiviral property respiratory tract infection clinical practice for many years and is used out Empirical formula, the in addition experimental basis of science, each component can play respective pharmacological action, can play again mutual collaborative work With, make pharmacological action strengthen, formula is reasonable, flavour of a drug refine, and the party is for treatment or preventing viral respiratory tract infection, and curative effect is true Cutting, and have no side effect, in popular period, all effective with prevention for treatment as general side, dosage form and preparation technology are suitable for Industrialized mass.
Detailed description of the invention
Present invention treatment or the Chinese medicine composition of prevention respiratory viral infection disease, former including following parts by weight Material medicine: Herba ephedrae 3-15 gram, Flos Farfarae 5-15 gram, Herba Schizonepetae 5-20 gram, Radix Asteris 5-15 gram, 10-15 gram of Semen Armeniacae Amarum, Fructus Perillae (parched) 5- 15 grams, Rhizoma Anemarrhenae 3-10 gram, Bulbus Fritillariae Thunbergii 3-10 gram, Fructus Arctii 5-20 gram, 2-10 gram of Radix Glycyrrhizae.For the curative effect reached, the present invention Medicine can combine with crude drug Radix Bupleuri, Radix Scutellariae;In order to reach more preferable curative effect, medicine of the present invention also can be with crude drug wood butterfly Butterfly, Lasiosphaera Seu Calvatia combine;In order to obtain optimum curative effect, medicine of the present invention also can combine with crude drug Radix Puerariae, Bulbus Fritillariae Cirrhosae.
Embodiment 1:
Weighting raw materials Herba ephedrae 10 grams, Flos Farfarae 10 grams, Herba Schizonepetae 10 grams, Radix Asteris 10 grams, 10 grams of Semen Armeniacae Amarum, Fructus Perillae (parched) 10 Gram, the Rhizoma Anemarrhenae 10 grams, Bulbus Fritillariae Thunbergii 10 grams, Fructus Arctii 10 grams, 10 grams of Radix Glycyrrhizae.Above ten herbal medicines totally 100 grams, boiling merges filter Liquid, concentrate, cool down, add ethanol and make alcohol content be 20-80%, reclaim ethanol, make supernatant concentration become thick paste, standby.Add β-ring Dextrin, heating for dissolving, stirs, filters, is spray-dried hot-air inlet temperature 180 DEG C, and leaving air temp 80 DEG C, spray powder adds to be adjusted Taste agent, mixing, material at a temperature of 40 DEG C dry granulation, granulate, be distributed into bag, obtain the present invention and treat viral respiratory sense The granule of dye.
Embodiment 2:
Weighting raw materials Herba ephedrae 10 grams, Flos Farfarae 10 grams, Herba Schizonepetae 10 grams, Radix Asteris 10 grams, 10 grams of Semen Armeniacae Amarum, Fructus Perillae (parched) 10 Gram, the Rhizoma Anemarrhenae 10 grams, Bulbus Fritillariae Thunbergii 10 grams, Fructus Arctii 10 grams, 10 grams of Radix Glycyrrhizae.Above ten herbal medicines totally 100 grams, boiling merges filter Liquid, concentrate, cool down, add ethanol and make alcohol content be 20-80%, reclaim ethanol, make supernatant concentration become thick paste, standby.Add in thick paste Enter 95% ethanol of 2 times of cream weights, be sufficiently stirred for, left at room temperature 24~48h, take supernatant, precipitate by 65% washing with alcohol 1~ 2 times, cleaning mixture merges with supernatant, if any alcohol extract, also merges with supernatant, filter clear and bright after, enter concentrating under reduced pressure tank or wine Essence recovery tower reclaims ethanol until medicinal liquid stops without alcohol taste.Medicinal liquid after dealcoholysis, after adding distilled water diluting, is heated to 100 DEG C, makes glue Body cohesion, tune pH4.5~5.0, then low temperature 0~4 DEG C of cold preservation 24h, make the colloidal precipitation of cohesion, then, filter to the most clear and bright, add Appropriate correctives and preservative, after standing, then filter clear and bright, and low-temp storage does last purification filtering before fill, filtrate is put Detect under lamp inspection instrument clear and bright after, upper mechanical irrigation is encapsulated in straight tube easy-open lid nutrition bottle, and every built-in 10ml ± 4% of oral liquid bottle to obtain final product The present invention treats the oral liquid of viral respiratory tract infection;Described correctives be stevioside, saccharin sodium, acesulfame-K, glycyrrhizin, Thiacyclohexane sulfamic acid, agedoite, alcohol sugar, radix asparagi sweet extract, Mentholum, various essence and various fruity material, consumption is 0.1 ~ 10%, described preservative be sorbic acid and k-na salt consumption be < 0.3%, methyl hydroxybenzoate class consumption be < 0.05%.
Embodiment 3:
Weighting raw materials Herba ephedrae 10 grams, Flos Farfarae 10 grams, Herba Schizonepetae 10 grams, Radix Asteris 10 grams, 10 grams of Semen Armeniacae Amarum, Fructus Perillae (parched) 10 Gram, the Rhizoma Anemarrhenae 10 grams, Bulbus Fritillariae Thunbergii 10 grams, Fructus Arctii 10 grams, 10 grams of Radix Glycyrrhizae, Radix Bupleuri 10 grams, more than 10 grams 12 herbal medicines of Radix Scutellariae altogether 120 grams, then the method as described in embodiment 1 makes granule.
Embodiment 4:
Weighting raw materials Herba ephedrae 10 grams, Flos Farfarae 10 grams, Herba Schizonepetae 10 grams, Radix Asteris 10 grams, 10 grams of Semen Armeniacae Amarum, Fructus Perillae (parched) 10 Gram, the Rhizoma Anemarrhenae 10 grams, Bulbus Fritillariae Thunbergii 10 grams, Fructus Arctii 10 grams, 10 grams of Radix Glycyrrhizae, Radix Bupleuri 10 grams, more than 10 grams 12 herbal medicines of Radix Scutellariae altogether 120 grams, then the method as described in embodiment 2 makes oral liquid.
Embodiment 5:
Weighting raw materials Herba ephedrae 10 grams, Flos Farfarae 10 grams, Herba Schizonepetae 10 grams, Radix Asteris 10 grams, 10 grams of Semen Armeniacae Amarum, Fructus Perillae (parched) 10 Gram, the Rhizoma Anemarrhenae 10 grams, Bulbus Fritillariae Thunbergii 10 grams, Fructus Arctii 10 grams, 10 grams of Radix Glycyrrhizae, Radix Bupleuri 10 grams, Radix Scutellariae 10 grams, Semen Oroxyli 10 grams, Lasiosphaera Seu Calvatia 10 grams.Above ten four Chinese medicine things totally 140 grams, then the method as described in embodiment 1 makes granule.
Embodiment 6:
Weighting raw materials Herba ephedrae 10 grams, Flos Farfarae 10 grams, Herba Schizonepetae 10 grams, Radix Asteris 10 grams, 10 grams of Semen Armeniacae Amarum, Fructus Perillae (parched) 10 Gram, the Rhizoma Anemarrhenae 10 grams, Bulbus Fritillariae Thunbergii 10 grams, Fructus Arctii 10 grams, 10 grams of Radix Glycyrrhizae, Radix Bupleuri 10 grams, Radix Scutellariae 10 grams, Semen Oroxyli 10 grams, Lasiosphaera Seu Calvatia 10 grams.Above ten four Chinese medicine things totally 140 grams, then the method as described in embodiment 2 makes oral liquid.
Embodiment 7:
Weighting raw materials Herba ephedrae 10 grams, Flos Farfarae 10 grams, Herba Schizonepetae 10 grams, Radix Asteris 10 grams, 10 grams of Semen Armeniacae Amarum, Fructus Perillae (parched) 10 Gram, the Rhizoma Anemarrhenae 10 grams, Bulbus Fritillariae Thunbergii 10 grams, Fructus Arctii 10 grams, 10 grams of Radix Glycyrrhizae, Radix Bupleuri 10 grams, Radix Scutellariae 10 grams, Semen Oroxyli 10 grams, Lasiosphaera Seu Calvatia 10 grams, Radix Puerariae 10 grams, Bulbus Fritillariae Cirrhosae 5 grams.Above ten six medicaments totally 155 grams, then the method as described in embodiment 1 is made Granule.
Embodiment 8:
Weighting raw materials Herba ephedrae 10 grams, Flos Farfarae 10 grams, Herba Schizonepetae 10 grams, Radix Asteris 10 grams, 10 grams of Semen Armeniacae Amarum, Fructus Perillae (parched) 10 Gram, the Rhizoma Anemarrhenae 10 grams, Bulbus Fritillariae Thunbergii 10 grams, Fructus Arctii 10 grams, 10 grams of Radix Glycyrrhizae, Radix Bupleuri 10 grams, Radix Scutellariae 10 grams, Semen Oroxyli 10 grams, Lasiosphaera Seu Calvatia 10 grams, Radix Puerariae 10 grams, Bulbus Fritillariae Cirrhosae 5 grams.Above ten six medicaments totally 155 grams, then the method as described in embodiment 2 makes mouth Take liquid.
Test example one: the laboratory observation of Chinese medicine composition In Vitro Anti rhinovirus (HRV, N36)
Test philosophy: with Human embryo epithelial cell as virus host, measures sample suppression rhinovirus and causes Human embryo epithelial cell Lesion degree.
Test material and method: 1. Strain: rhinovirus (HRV, N36).
. sample treatment: the thick paste that Example 1,3,5,7 prepares is dissolved in water and is respectively prepared the solution of 1000mg/ml Bottle standby;3000rpm takes supernatant after being centrifuged 20 minutes, and the sodium citrate with 50% adjusts pH7.2~7.6, is poured into sterile test tube In, 121 DEG C, 15 20 minutes autoclavings, take out in rearmounted 4 DEG C of refrigerators and save backup;Solution example culture fluid during experiment 1:10 dilution starts, and makees 2 times of dilutions, totally 8 dilution factors.
. positive control drug: ribavirin (RBV) Jiangxi Huiren Pharmaceutical Co., Ltd produces.
. method of testing:
1. by Human embryo epithelial cell (2~4) × 1050.1ml is inoculated into 96 hole micro plastics culture plates, every hole 100 μ l 37 DEG C, 5%CO2Cultivate 1~2 day, grow into cell monolayer.Cell growth medium is MEM100ml, containing hyclone 10%, 3% glutamy Amine 1%, penicillin and streptomycin each 100U/ml, NaHCO3 5%;When cell grows up to monolayer, abandon growth-promoting media, need before virus inoculation to use PBS or the Hanks liquid of pre-temperature washes cell two times.
2. drain, add 100 μ l 10~100TCID50Viral suspension infection cell, 37 DEG C of absorption 1~2h, abandon virus liquid, Add the maintenance liquid 100 μ l containing variable concentrations testing compound, each concentration 2 hole, 37 DEG C of 5%CO again2Incubation continues Cultivate.If normal cell controls, drug toxicity control, virus control, ribavirin (RBV) positive control and virus TCID50Drip Fixed.
3. check under inverted microscope every day and record cytopathy (< 25% be a plus sige, 25~50% is two adds Number, 50~75% be three plus siges, 75~100% is four plus siges), until virus control wells (being not added with testing compound) occurs 3~4 It is experimental endpoints during the cytopathy of individual plus sige.Record each porocyte lesion degree, calculate often group average cell lesion degree, with Virus control group compares, and calculates suppression 50% cytopathic compound concentration i.e. half suppression by Reed and Muench method dense Degree (IC50).
Press the toxicity to cell of the criterion calculation medicine 3. the most simultaneously, calculate generation 50% by Reed and Muench method thin The compound concentration of born of the same parents' pathological changes i.e. half toxic concentration (TD50).
⑤ TD50/ IC50For selecting index (SI).
5. experimental result
Test example two: the laboratory observation of Chinese medicine composition In Vitro Anti influenza virus A type
Test philosophy: with MDCK(Madin-Darby canine kidney(cell line) (MDCK)) as virus host, measure sample suppression influenza virus A type and cause mdck cell Lesion degree.
Test material and method:
1. Strain :/243/72 (H3N2) is prevented in influenza virus A type A/ Guangdong.
2. sample treatment: the thick paste that Example 2,4,6,8 prepares is dissolved in water and is respectively prepared the solution of 1000mg/ml Bottle standby;3000rpm takes supernatant after being centrifuged 20 minutes, and the sodium citrate with 50% adjusts pH7.2~7.6, is poured into sterile test tube In, 121 DEG C, 15 20 minutes autoclavings, take out in rearmounted 4 DEG C of refrigerators and save backup;Solution example culture fluid during experiment 1:10 dilution starts, and makees 2 times of dilutions, totally 8 dilution factors.
3. positive control drug: oseltamivir phosphate capsule.
4. method of testing: 1. by mdck cell (2~4) × 1050.1ml is inoculated into 96 hole micro plastics culture plates, often Hole 100 μ l 37 DEG C, 5%CO2Cultivate 1~2 day, grow into cell monolayer.Cell growth medium is MEM 100ml, containing hyclone 10%, 3% glutamine 1%, penicillin and streptomycin each 100U/ml, NaHCO3 5%;Maintain liquid not increase serum, because serum includes Have suppression influenza virus replicate nonspecific inhibitor, when cell grows up to monolayer, need before virus inoculation the PBS by pre-temperature or Hanks liquid washes cell two times, to remove the growth-promoting media containing Ox blood serum of residual, substitutes Ox blood serum with 1% albumin 10%, and adds 0.25% pancreatin 0.2%, the same growth-promoting media of other compositions.
2. abandon growth-promoting media, drain, add 100 μ l 10~100TCID50Viral suspension infection cell, 37 DEG C of absorption 1~2h, Abandon virus liquid, then add the maintenance liquid 100 μ l containing variable concentrations testing compound, each concentration 2 hole, 37 DEG C of 5%CO2Temperature Case hatches continuation cultivation.If normal cell controls, drug toxicity control, virus control, ribavirin (RBV) positive control and disease Poison TCID50Titration.
3. check under inverted microscope every day and record cytopathy (< 25% be a plus sige, 25~50% is two adds Number, 50~75% be three plus siges, 75~100% is four plus siges), until virus control wells (being not added with testing compound) occurs 3~4 It is experimental endpoints during the cytopathy of individual plus sige.Record each porocyte lesion degree, calculate often group average cell lesion degree, with Virus control group compares, and calculates suppression 50% cytopathic compound concentration i.e. half suppression by Reed and Muench method dense Degree (IC50).
Press the toxicity to cell of the criterion calculation medicine 3. the most simultaneously, calculate generation 50% by Reed and Muench method thin The compound concentration of born of the same parents' pathological changes i.e. half toxic concentration (TD50).
⑤ TD50/ IC50For selecting index (SI).
5. experimental result
Test example three: the clinical observation of traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection
1.1 data and method
1.1.1 clinical data
This group case is the patient of the rhinovirus upper respiratory tract infection that in December, 20012 in December, 2015 is made a definite diagnosis, and age 1 ~ 61 years old, meeting the patient of following Chinese and western medicine diagnostic criteria, 120 example patients are randomly divided into treatment group (Chinese medicine composition) 60 example, right According to group (ribavirin) 60 example.Treatment group 60 example is assigned randomly to embodiment example 1,3,5,7 groups (being called for short treatment group A, B, C, D) Each 15 examples, matched group 60 example is randomly divided into four groups of (be called for short control group A, B, C, D) each 15 examples, two groups sex, the age, the course of disease and The upper not statistically significant (P > 0.01) of state of an illness distribution.
1.1.2 diagnostic criteria
1.1.2.1 Western medicine diagnose standard
(1) clinical symptoms: have the rhinovirus infection medical history of affirmative, Acute onset, the course of disease≤2 day;With heating, aversion to cold, headache, The symptoms such as nasal obstruction, sneeze, watery nasal discharge, dry pharynx are itched, coughed, hoarseness;
(2) health check-up: pharyngeal congestion, antiadoncus, two pulmonary respiration sounds are the most coarse or the most coarse;
(3) Serological testing: using RT-PCR method detection rhinovirus positive, peripheral blood conventional white cell calculates and classification is all just Often between scope or numeration of leukocyte is low;
(4) x-ray chest film inspection is normal.
1.1.2.2 tcm diagnosis standard:
Clinically with heating, aversion to cold, have a headache, have a stuffy nose, the symptom such as sneeze, watery nasal discharge, dry pharynx are itched, cough, hoarseness as principal character, tongue The thin Huang of the reddest, tongue, slippery and rapid pulse.
1.2 Therapeutic Method
Treatment group gives Chinese medicinal composition granules, and oral, every day twice, each consumption is equivalent to each raw medicinal herbs 10g;Matched group By ribavirin effervescent granules 150mg/ time, three times a day, oral.Child is cut down according to the circumstance.The course for the treatment of is 5 days.
1.3 criterion of therapeutical effect
Criterion of therapeutical effect:
Recovery from illness: treat five days internal heat generations, aversion to cold, have a headache, have a stuffy nose, the clinical symptoms body such as sneeze, watery nasal discharge, dry pharynx are itched, cough, hoarseness Levy disappearance;
Effective: treat five days internal heat generations, aversion to cold, have a headache, have a stuffy nose, the clinical symptoms body such as sneeze, watery nasal discharge, dry pharynx are itched, cough, hoarseness Levy and alleviate more than 2/3;
Effective: treat five days internal heat generations, aversion to cold, have a headache, have a stuffy nose, the clinical symptoms body such as sneeze, watery nasal discharge, dry pharynx are itched, cough, hoarseness Levy and alleviate 2/3~1/3;
Invalid: in treating five days, conscious or other symptoms are all not improved or increase the weight of.
1.4 result
Use Chinese medicine composition (treatment group A) the treatment rhinovirus upper respiratory tract infection of embodiment of the present invention example 1, result table Bright: compare heating, aversion to cold before and after two groups of patient's total effective rates and medication, have a headache, have a stuffy nose, sneeze, watery nasal discharge, dry pharynx are itched, cough, sound The clinical symptoms such as neigh improves situation, treatment group A clinical improvements total effective rate 66.98%;Control group A clinical improvements total effective rate 38.89%;Treatment group A and control group A comparing difference statistically significant (P < 0.01).Poison is not found in clinical treatment observation Side effect.Clinical effectiveness is pointed out: embodiment of the present invention example 1 traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection curative effect is full Meaning, in terms of alleviating clinical symptoms time and total effective rate and cure rate, Chinese drug-treated group is superior to ribavirin group.
Use Chinese medicine composition (treatment group B) the treatment rhinovirus upper respiratory tract infection of embodiment of the present invention example 3, result Show: compare heating, aversion to cold before and after two groups of patient's total effective rates and medication, have a headache, have a stuffy nose, sneeze, watery nasal discharge, dry pharynx are itched, cough, The clinical symptoms such as hoarseness improve situation, treatment group B clinical improvements total effective rate 85.66%;Matched group B clinical improvements total effective rate 41.92%;Treatment group B and matched group B comparing difference statistically significant (P < 0.01).Poison is not found in clinical treatment observation Side effect.Clinical effectiveness is pointed out: embodiment of the present invention example 3 traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection curative effect is full Meaning, in terms of alleviating clinical symptoms time and total effective rate and cure rate, Chinese drug-treated group is superior to ribavirin group.
Use Chinese medicine composition (treatment group C) the treatment rhinovirus upper respiratory tract infection of embodiment of the present invention example 5, result Show: compare heating, aversion to cold before and after two groups of patient's total effective rates and medication, have a headache, have a stuffy nose, sneeze, watery nasal discharge, dry pharynx are itched, cough, The clinical symptoms such as hoarseness improve situation, treatment group C clinical improvements total effective rate 79.01%;Matched group C clinical improvements total effective rate 40.31%;Treatment group C and matched group C comparing difference statistically significant (P < 0.01).Poison is not found in clinical treatment observation Side effect.Clinical effectiveness is pointed out: embodiment of the present invention example 5 traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection curative effect is full Meaning, in terms of alleviating clinical symptoms time and total effective rate and cure rate, Chinese drug-treated group is superior to ribavirin group.
Use Chinese medicine composition (treatment group D) the treatment rhinovirus upper respiratory tract infection of embodiment of the present invention example 7, result Show: compare heating, aversion to cold before and after two groups of patient's total effective rates and medication, have a headache, have a stuffy nose, sneeze, watery nasal discharge, dry pharynx are itched, cough, The clinical symptoms such as hoarseness improve situation, treatment group D clinical improvements total effective rate 75.12%;Matched group D clinical improvements total effective rate 40.18%;Treatment group D and matched group D comparing difference statistically significant (P < 0.01).Poison is not found in clinical treatment observation Side effect.Clinical effectiveness is pointed out: embodiment of the present invention example 7 traditional Chinese medicine composition for treating rhinovirus upper respiratory tract infection curative effect is full Meaning, in terms of alleviating clinical symptoms time and total effective rate and cure rate, Chinese drug-treated group is superior to ribavirin group.
Test example four: the clinical observation that traditional Chinese medicine composition for treating Influenza B virus infects
1.1 data and method
1.1.1 clinical data
This group case is the patient that the Influenza B virus made a definite diagnosis in February, 2014 in April, 2016 infects, 6 ~ 69 years old age, Meeting the patient of following Chinese and western medicine diagnostic criteria, 120 example patients are randomly divided into treatment group (Chinese medicine composition) 60 example, matched group (ribavirin) 60 example.Treatment group 60 example is assigned randomly to embodiment example 2,4,6,8 groups (being called for short treatment group A, B, C, D) each 15 Example, matched group 60 example is randomly divided into four groups of (being called for short control group A, B, C, D) each 15 examples, and two groups in sex, age, the course of disease and the state of an illness Not statistically significant (P > 0.05) in distribution.
1.1.2 diagnostic criteria
1.1.2.1 Western medicine diagnose standard
(1) clinical symptoms: have the influenza infection medical history of affirmative, Acute onset, the course of disease≤2 day;With generating heat, cough up phlegm, sound Neigh, pharyngalgia, QI rising in reverse order, the symptom such as tachypnea;
(2) health check-up: body temperature raises, pharyngeal congestion, regional nodes's silght enlargement or tenderness, two lung audibles and dryness or moist Rale;
(3) lab testing: use RT-PCR method detection Influenza B virus positive, peripheral blood conventional white cell counting and classification All between normal range or numeration of leukocyte is low;
(4) bronchitis or pneumonia seen from x-ray rabat or CT examination.
1.1.2.2 tcm diagnosis standard:
Clinical symptoms to generate heat, to cough, to cough up phlegm, hoarseness, pharyngalgia, QI rising in reverse order, tachypnea as principal character, reddish tongue, yellow and thin fur, rolling pulse Number.
1.2 Therapeutic Method
Treatment group gives Chinese medicinal composition granules, and oral, every day twice, each consumption is equivalent to each raw medicinal herbs 10g;Matched group By ribavirin effervescent granules 150mg/ time, three times a day, oral.Child is cut down according to the circumstance.The course for the treatment of is 7 days.
1.3 criterion of therapeutical effect
Criterion of therapeutical effect:
Recovery from illness: treat internal heat generation in seven days, cough, cough up phlegm, hoarseness, pharyngalgia, QI rising in reverse order, the Clinical symptom and sign disappearance such as tachypnea;
Effective: treat internal heat generation in seven days, cough, cough up phlegm, hoarseness, pharyngalgia, QI rising in reverse order, the Clinical symptom and sign such as tachypnea alleviate 2/3 with On;
Effective: treat internal heat generation in seven days, cough, cough up phlegm, hoarseness, pharyngalgia, QI rising in reverse order, the Clinical symptom and sign such as tachypnea alleviate 2/3~ 1/3;
Invalid: in treating seven days, conscious or other symptoms are all not improved or increase the weight of.
1.4 result
The Chinese medicine composition (treatment group A) using embodiment of the present invention example 2 is controlled Influenza B virus and is infected, and result shows: ratio Generate heat before and after relatively two groups of patient's total effective rates and medication, cough, cough up phlegm, hoarseness, pharyngalgia, QI rising in reverse order, the clinical symptoms such as tachypnea are improved Situation, treatment group A clinical improvements total effective rate 63.98%;Control group A clinical improvements total effective rate 30.81%;Treatment group A is with right According to group A comparing difference statistically significant (P < 0.05).Toxic and side effects is not found in clinical treatment observation.Clinical effectiveness carries Show: embodiment of the present invention example 2 traditional Chinese medicine composition for treating Influenza B virus lower respiratory infection satisfactory effect, alleviating clinic Symptom time and total effective rate and cure rate aspect Chinese drug-treated group are superior to ribavirin group.
Chinese medicine composition (treatment group B) the treatment Influenza B virus using embodiment of the present invention example 4 infects, result table Bright: generate heat before and after comparing two groups of patient's total effective rates and medication, cough, cough up phlegm, hoarseness, pharyngalgia, QI rising in reverse order, the clinical symptoms such as tachypnea Improvement situation, treatment group B clinical improvements total effective rate 79.96%;Matched group B clinical improvements total effective rate 37.69%;Treatment group B Statistically significant with matched group B comparing difference (P < 0.05).Toxic and side effects is not found in clinical treatment observation.Clinical knot Fruit prompting: embodiment of the present invention example 4 traditional Chinese medicine composition for treating Influenza B virus lower respiratory infection satisfactory effect, is alleviating Clinical symptoms time and total effective rate and cure rate aspect Chinese drug-treated group are superior to ribavirin group.
Use Chinese medicine composition (treatment group C) the treatment Influenza B virus lower respiratory tract sense of embodiment of the present invention example 6 Dye, result shows: compare fever with chills before and after two groups of patient's total effective rates and medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, The clinical symptoms such as QI rising in reverse order, tachypnea improves situation, treatment group C clinical improvements total effective rate 72.01%;Matched group C clinical improvements always has Efficiency 36.01%;Treatment group C and matched group C comparing difference statistically significant (P < 0.05).Clinical treatment observation is not sent out Existing toxic and side effects.Clinical effectiveness is pointed out: embodiment of the present invention example 6 traditional Chinese medicine composition for treating Influenza B virus lower respiratory tract sense Dye satisfactory effect, in terms of alleviating clinical symptoms time and total effective rate and cure rate, Chinese drug-treated group is superior to ribavirin group.
Chinese medicine composition (treatment group D) the treatment Influenza B virus using embodiment of the present invention example 8 infects, result table Bright: compare fever with chills before and after two groups of patient's total effective rates and medication, cough, cough up phlegm, nasal mucus, hoarseness, stridulate, QI rising in reverse order, tachypnea Situation, treatment group D clinical improvements total effective rate 66.96% is improved etc. clinical symptoms;Matched group D clinical improvements total effective rate 37.09%;Treatment group D and matched group D comparing difference statistically significant (P < 0.05).Poison is not found in clinical treatment observation Side effect.Clinical effectiveness is pointed out: embodiment of the present invention example 8 traditional Chinese medicine composition for treating Influenza B virus infects satisfactory effect, In terms of alleviating clinical symptoms time and total effective rate and cure rate, Chinese drug-treated group is superior to ribavirin group.
Upper content is to combine concrete preferred implementation further description made for the present invention, it is impossible to assert this Invention be embodied as be confined to these explanations.For general technical staff of the technical field of the invention, not On the premise of departing from present inventive concept, it is also possible to make some simple deduction or replace, all should be considered as belonging to the guarantor of the present invention Protect scope.

Claims (7)

1. treat the Chinese medicine composition of respiratory viral infection disease, it is characterised in that: include the raw material of following parts by weight Medicine: Herba ephedrae 3-20 part, Flos Farfarae 3-20 part, Herba Schizonepetae 5-25 part, Radix Asteris 5-20 part, Semen Armeniacae Amarum 5-15 part, Fructus Perillae (parched) 5-20 Part, Rhizoma Anemarrhenae 3-15 part, Bulbus Fritillariae Thunbergii 3-15 part, Fructus Arctii 5-25 part, Radix Glycyrrhizae 2-15 part.
The Chinese medicine composition for the treatment of respiratory viral infection disease the most according to claim 1, the wherein use of crude drug Amount it may also is that Herba ephedrae 3-15 part, Flos Farfarae 5-15 part, Herba Schizonepetae 5-20 part, Radix Asteris 5-15 part, Semen Armeniacae Amarum 10-15 part, fry purple Fructus Perillae 5-15 part, Rhizoma Anemarrhenae 3-10 part, Bulbus Fritillariae Thunbergii 3-10 part, Fructus Arctii 5-20 part, Radix Glycyrrhizae 2-10 part.
The Chinese medicine composition for the treatment of respiratory viral infection disease the most according to claim 2, wherein crude drug also has: Radix Bupleuri 5-20 part, Radix Scutellariae 5-15 part.
4. treat the Chinese medicine composition of respiratory viral infection disease according to claim 3, wherein crude drug also has: Semen Oroxyli 10-30 part, Lasiosphaera Seu Calvatia 10-20 part.
The Chinese medicine composition for the treatment of respiratory viral infection disease the most according to claim 4, wherein crude drug also has: Radix Puerariae 10-80 part, Bulbus Fritillariae Cirrhosae 5-20 part.
The Chinese medicine composition for the treatment of respiratory viral infection disease the most according to claims 1 to 5, it is characterised in that: The dosage form of described compositions is: capsule, oral liquid, granule, syrup, tablet, effervescent granule, drop pill, aerosol, spraying Agent, gargarisma, collutory;Wherein said tablet is oral cavity disintegration tablet, effervescent tablet.
The Chinese medicine composition for the treatment of respiratory viral infection disease the most according to claims 1 to 5, it is characterised in that: Can be clinically used for treatment or prevention by influenza A virus, Influenza B virus, rhinovirus, coronavirus, respiratory syncystial The respiratory virus infection that virus, hand-foot-mouth disease virus, adenovirus, parainfluenza virus, echovirus, Coxsackie virus etc. are caused Property disease.
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Application publication date: 20161012