CN103028001B - It is a kind of be used for relieving asthma, the Chinese prescription of antibechic, anti-inflammatory, Its Preparation Method And Use - Google Patents

Abstract

The present invention relates to a kind of Chinese medical extract being made up of the Chinese medicine material including Chinese ephedra, radix scutellariae, radix glycyrrhizae and oil of negundo chastetree, comprising liquiritin, Chinese ephedra total alkali, scutelloside and oil of negundo chastetree as the Traditional Chinese drug mixture of active component and the Chinese medicine composition comprising the Chinese medical extract or Traditional Chinese drug mixture, and they are in clinical application.The prescription of the present invention have anti-inflammatory, antipyretic, spasmolysis, relieving asthma, antibechic, eliminating the phlegm, enhancing immune, antibacterium or antivirus action, available for treating and/or prevent inflammation in respiratory system, bronchitis, tracheitis, pneumonia etc..

Description

It is a kind of be used for relieving asthma, the Chinese prescription of antibechic, anti-inflammatory, Its Preparation Method And Use

Technical field

The present invention relates to a kind of Chinese medical extract being made up of the Chinese medicine material including Chinese ephedra, radix scutellariae, radix glycyrrhizae and oil of negundo chastetree, Carried comprising liquiritin, Chinese ephedra total alkali, scutelloside and oil of negundo chastetree as the Traditional Chinese drug mixture of active component and comprising the Chinese medicine The Chinese medicine composition of thing or Traditional Chinese drug mixture is taken, and they are in clinical application.The Chinese medical extract of the present invention, Chinese medicine mixing Thing and Chinese medicine composition have anti-inflammatory, antipyretic, spasmolysis, relieving asthma, antibechic, eliminating the phlegm, enhancing immune, antibacterial or the effect such as antiviral, Available for treating and/or prevent inflammation in respiratory system, bronchitis, tracheitis, pneumonia etc..

Background technology

Inflammation in respiratory system be as bacterium, virus and physically or chemically stimulate etc. trachea-bronchial epithelial cell caused by factor and Lung inflammation.Morbidity season is common with Winter-Spring, and the incidence of disease is directly proportional to the age, especially using northern China rural area to be multiple.

Inflammation in respiratory system is divided into acute and chronic two kinds, wherein chronic bronchitis is more common according to the length of the course of disease The elderly, so there is the title of " old-slow-bronchial tube " again.The slow branch incidence of disease is high, Relapse rate, can concurrently obstructive emphysema, or even lung Arterial hypertension, cor pulmonale, have a strong impact on the live and work of patient.

If inflammation in respiratory system repeated infection is often easily caused obstructive emphysema, small number of patients can concurrent bronchiectasis. Inflammation in respiratory system belongs to categories such as " coughs ", " phlegm and retained fluid ", " cough and asthma " of traditional Chinese medicine.Think that exopathogen invasion and attack and lung, spleen, kidney three are dirty Malfunction, is the main cause for causing this sick.Human righteousness is not enough, defends outer dereliction of duty, being invaded by exogenous pathogen,invasion of exogenous pathogen, exopathogen both can be chill Heresy or wind-heat heresy, also can chill heresyization heat, invade lungs, make lung lose a surname it is respectful；Or insufficiency of lung-QI, weakened defensive QI, Exopathogen is felt again；Or weak with age, spleen-lung Qi deficiency, the dysfunction of the spleen in transport, it is wet to be polymerized to phlegm, stop storing in lung；Or lung has chronic ill, multiple sense is outer It is evil；Or after prolonged illness, kidney is undermined by spleen and lung, cause deficiency of kidney-QI, gas of receiving is had no right.

Chinese medicine species is various, different compatibilities, and the effect that treatment is propped up slowly is each variant, and such as danggui liuhuang decoction can adjust body Equilibrium between yin and yang, improves and enhancing immunity of organisms, improves treatment rate, and have no adverse reaction；Linggui zhugan decoction, which is cured mainly under the heart, phlegm Drink, distention and fullness in the chest and hypochondrium sets for phlegm and retained fluid disease；The work(that cortex mori decoction plus-minus is relievingd asthma with clearing heat and eliminating phlegm, respectful lung；Belamcanda mahuangtang is cured mainly Cough and asthma is unable to ring such as water bird sound, thin white phlegm between prostration, larynx, does not drink yearningly, and tongue is white, stringy and tense pulse etc.；Gas drops in Suzi Jiangqi Tang Phlegm disappears, then breathes with cough from flat；Xuanbaichengqitang facilitaing lung leads to internal organs, and internal organs are with controlling, and ascending or descending movement of vital Qi recovers normal, then cough, syndrome characterized by dyspnea, constipation All diseases can eliminate certainly；Five tastes sea-buckthorn is dissipated for Mongols's proved recipe, and with relieving cough and relieving asthma, heat-clearing eliminating the phlegm effect, clinic is mainly used in lung Heat is coughed long, syndrome characterized by dyspnea abundant expectoration, and full vexed in the heart, chest side of body is had a pain.

The content of the invention

The present inventor comes from theory of traditional Chinese medical science, summarizes multi-party experience, has made the present invention.

Traditional medicine thinks that lung governing qi category is defended, outer conjunction fur.Exopathogen is attacked, and PFT is not normal, is cause this disease main Reason.Human righteousness is not enough, defends outer dereliction of duty, being invaded by exogenous pathogen,invasion of exogenous pathogen, exopathogen both can be the heresy of chill or the heresy of wind-heat, also may be used The heresyization heat of chill, invades lungs, lung is lost a surname respectful；Or insufficiency of lung-QI, weakened defensive QI, exopathogen is felt again, and the dysfunction of the spleen in transport is wet to be polymerized to Phlegm, stops storing in lung.The heresy of chill is outer to attack fleshy exterior, makes defensive yang being obstructed, and space between skin and muscles occlusion, a surname of influence lung qi is respectful descending, then superinverse is Breathe heavily.Control to work as and freeing lung and relieving asthma.Square epheday intermedia toil is warm-natured, return lung and bladder warp, kind to open natural fibre line of meat sweating, dispels in the chill of table；Property lightly floats, Only cough with dyspnea, freeings lung and relieving asthma, and is opened and closed strongly fragrant lung qi, dissipates lung channel stagnated fire, therefore we are to for monarch drug in a prescription.Radix scutellariae bitter cold, can rush down The fire of lung channel qi leel, has the work(of sharp gas dissolving phlegm concurrently.With Chinese ephedra compatibility, for the strongly fragrant lung of phlegm heat, the card of impairment of dispersing and descending function of the lung plays clear facilitaing lung Gas, the effect of clearing lung and eliminating phlegm.It is Vitex negundo var cannabifolia slight bitter, pungent, put down.Hardship can drop, pungent to dissipate；Then resolving sputum is dropped, and scattered then wind-dispelling, the disease of wind phlegm is suitable It.Radix glycyrrhizae is sweet flat, and slow lung qi is anxious, and middle shield is just.Simultaneously have expelling phlegm and arresting coughing work(, and can anti-Chinese ephedra sweating too with hinder just Gas.All medicines share, heat-clearing eliminating the phlegm, relieving cough and relieving asthma.

Therefore, in the first aspect, the invention provides a kind of Chinese medical extract, it is by including the raw material system of following Chinese medicine Into：Chinese ephedra 100-200 parts by weight, radix scutellariae 100-200 parts by weight, radix glycyrrhizae 100-200 parts by weight, oil of negundo chastetree 0.2-1 parts by weight.

In a preferred embodiment, Chinese medical extract of the invention mainly includes liquiritin, Chinese ephedra total alkali, scutelloside With oil of negundo chastetree isoreactivity composition.

In second aspect, the invention provides a kind of Traditional Chinese drug mixture, it includes following active component：Liquiritin, Chinese ephedra total alkali, scutelloside and oil of negundo chastetree, wherein liquiritin, Chinese ephedra total alkali, scutelloside, the weight ratio of oil of negundo chastetree are 2~2.5: 1: 2 ~2.5: 0.02~0.2, preferably 2.5: 1: 2.5: 0.04.The liquiritin, Chinese ephedra total alkali, scutelloside and oil of negundo chastetree can be respective It is prepared from or commercially available finished product by the extracting method of the present invention by medicinal materials such as radix glycyrrhizae, Chinese ephedra, radix scutellariae and Vitex negundo var cannabifolias.

It is medicinal auxiliary with one or more that the Chinese medical extract or Traditional Chinese drug mixture of the present invention is also used as active ingredient Chinese medicine composition is made according to method well known in the art together in material, excipient, diluent or solvent.

At the 3rd aspect, the invention provides the preparation method of the Chinese medical extract of the present invention, this method includes following Step：

1) Herba Ephedrae segment, plus 10-16 times of decocting is taken to boil 2-4 times.1-3 hours every time, filtration, filtrate was concentrated to dryness, It is standby；

2) baikal skullcap root decoction pieces are taken, plus 6-10 times is measured water, is decocted 2-4 times, each 1-2 hours, collecting decoction, is concentrated into 1/3 and is decocted Liquid is accumulated, regulation pH value to 4.0, and viscous paste impurity is removed after standing 1 hour, takes supernatant, and regulation pH value is quiet at 4 DEG C to 2.0 Put 12-24 hours, abandoning supernatant, precipitating the stirring that adds water makes it be suspended, and filters out impurity, is deposited at 80 DEG C and is dried under reduced pressure, standby With；

3) extracting liquorice medicinal material adds 10-16 times to measure decocting and boiled 2-4 times, each 2-3 hours, collecting decoction, filtration, filtrate concentration To 1/2 volume, adjust pH value to 2.0, standing is stopped when being separated out without yellow mercury oxide, abandoning supernatant, be deposited at 60 DEG C and depressurize Dry, it is standby；

4) according to oil of negundo chastetree：Beta-schardinger dextrin：The weight ratio that water is 1: 6~10: 50~100, takes the beta-schardinger dextrin of respective amount, It is added to the water, heating is allowed to be completely dissolved, puts and be cooled to less than 50 DEG C at room temperature, side is stirred, side addition Herba Viticis Cannabifoliae volatile oil, and Under constant temperature continue stir 1-3 hour, put 4 DEG C stand 8-12 hours, suction filtration sediment to do；

5) by step 1)~step 4) in obtain product mixing produce.

In above-mentioned preparation method, the medicinal material amount used is respectively：Chinese ephedra 100-200 parts by weight, radix scutellariae 100-200 weight Part, radix glycyrrhizae 100-200 parts by weight, oil of negundo chastetree 0.2-1 parts by weight.

At the 4th aspect, carried the invention provides the Chinese medical extract of the present invention, Traditional Chinese drug mixture or comprising the Chinese medicine Take the purposes of thing or the Chinese medicine composition of the Traditional Chinese drug mixture, the Chinese medical extract, Traditional Chinese drug mixture and Chinese medicine composition tool Have anti-inflammatory, antipyretic, spasmolysis, relieving asthma, antibechic, eliminating the phlegm, enhancing immune, antibacterial or at least one of antiviral effect.In described Medicament extract and Chinese medicine composition can be used for treating and/or preventing inflammation in respiratory system, such as bronchitis, tracheitis, pneumonia Deng.

At the 5th aspect, carried the invention provides the Chinese medical extract of the present invention, Traditional Chinese drug mixture or comprising the Chinese medicine Purposes of the Chinese medicine composition of thing or the Traditional Chinese drug mixture in medicine is prepared is taken, the medicine is used under treating and/or preventing At least one of row clinical symptoms：Cough, heating, expiratory dyspnea, spitting of blood, expectoration, out of breath, wheezing, pant, pectoralgia etc..

At the 6th aspect, carried the invention provides the Chinese medical extract of the present invention, Traditional Chinese drug mixture or comprising the Chinese medicine Purposes of the Chinese medicine composition of thing or the Traditional Chinese drug mixture in medicine is prepared is taken, the medicine is used under treating and/or preventing Arrange at least one of clinical sign：Hyperpyrexia, sweating and do not understand, cough out of breath, nose incites rough, cough up phlegm yellow thick or cough up iron rust Color phlegm, pectoralgia, thirsty agitation, dark urine is hard and dry.Red tongue with yellowish fur, slippery and rapid pulse or big vast number.

The present invention obtains state natural sciences fund (81073060) subsidy.

Embodiment

Chinese medicinal material is summarized

The Chinese ephedra (Herbal Ephedrae) mentioned in the present invention is Ephedraceae plant ephedra sinica (Ephedra Sinica), the herbaceous stem stem of epheday intermedia (Ephedra intermedia) or ephedra equisetina (Ephedra equisetina), is one Kind of wind-cold-dispersing medicinal, its main active chemical include organic amine alkaloids (including L- ephedrines (L-ephedrine), D-pseudo-ephedrine (d-pseudoephedrine), L-N- methylephedrines etc.；Oxazolone Alkaloid：Chinese ephedra oxazolone (ephedroxane)；Volatile oil：- 3 cyclohexene of α, α, 4- trimethyl-methanol (α, α -4-trimethyl-3-cyclohexen- 1-methanol), β-terpinol (β-terpineol) etc.；Flavone compound：Apiolin (apigenin), tricin (tricin), Kaempferol (laemplerol), apiolin -5- rhamnoses (apigenin-5-rhamnoside) etc..The master of Chinese ephedra Pharmacological action is wanted to include：Sweating；Relieving asthma；Diuresis；Anti-inflammatory, antiallergy；Antibechic, eliminating the phlegm；Antipyretic, antibacterial, antiviral etc..In this hair Above-mentioned three kinds of Chinese ephedras can use as medicinal material in bright, and in the present invention can be directly total using the Chinese ephedra therefrom extracted Alkali.

The radix scutellariae (Radix Scutellariae) mentioned in the present invention is labiate scutellaria Scutellaria Baicalensis Georgi root, its main chemical compositions include scutelloside (baicalin), baicalein (baicalein), Wogonoside (wogonoside), wogonin (wogonin), radix scutellariae ketone I, II (skullcapflavone I, II), thousand layers Paper yellow element A (oroxy-linA) and campesterol.Radix scutellariae primary efficacy heat-clearing and damp-drying drug, purging intense heat and detonicating, cooling blood and hemostasis, except heat peace Tire radix scutellariaes mainly contain scutelloside, baicalein, wogonin, the composition such as wogonoside, neobaicalein, cupreol, in the present invention In can directly use the scutelloside that therefrom extracts.Its antimicrobial spectrum is wider, to various bacteria, dermatophyte, Leptospira Deng there is inhibitory action.It is still very quick to radix scutellariae even if the staphylococcus aureus developed immunity to drugs to antibiotic such as penicillin Sense.Radix scutellariae also has the effects such as hypotensive, calmness, diuresis, liver protection, cholagogic, antiallergy, releasing smooth muscle spasm, has with ephedrine Synergy.

The radix glycyrrhizae mentioned in the present invention is glycyrrhizic legume Glycyrrhiza uralensis Fisch., swollen fruit Radix G.inflata Bat. or glycyrrhiza glabra G.glabra L. root and rhizome.Main chemical compositions include triterpenes (triterpene soap The potassium of glycosides glycyrrhizic acid, calcium salt are glycyrrhizin, are the sweet ingredients of radix glycyrrhizae), flavonoids, alkaloid, polysaccharide etc., in the present invention Can be directly using the liquiritin therefrom extracted.Radix glycyrrhizae has anti-arrhythmia cordis to act on；There is antiulcer, gastric acid secretion inhibiting is alleviated Gastrointestinal smooth muscle spasmus and analgesic activity, and have synergy with Chinese herbaceous peony the effective elements of the medicine Paeoniflorin；Pancreatic secretion can be promoted；Have Obvious antitussive effect, phlegm-dispelling functions are also more significant, also certain antiasthmatic effect；There are antibacterial, antiviral, anti-inflammatory, antiallergy to make With；The throat and tunica mucosa tracheae of inflammation can be protected；There is the detoxication of similar glucuronic acid to some poisonous substances；Have on similar kidney Gland cortin sample is acted on；Also antidiuresis, lipid-loweringing, liver protection etc. are acted on.

The oil of negundo chastetree mentioned in the present invention is Verbenaceae Vitex negundo var cannabifolia Vitex negundo The volatile oil that L.var.cannabifolia (Sieb.et Zucc.) Hand.-Mazz. fresh leaf is obtained through steam distillation. Oil of negundo chastetree has eliminating the phlegm, and cough-relieving, effect relievingd asthma is usually used in treating chronic bronchitis.

Pharmaceutical dosage form

The Chinese medical extract of the present invention can further respectively with one or more auxiliary materials, excipient, diluent, solvent, steady Determine the pharmaceutical carriers such as agent, disintegrant, flavor enhancement, colouring agent, PH conditioning agents, dispersant, isotonic agent and/or other additives to be made Appropriate pharmaceutical dosage form.During the formulation for including the medicine of the present invention is prepared, Chinese medical extract of the invention or Chinese medicine group Compound is generally ground by conventional mixing, dissolving, granulation, ingot processed with one or more pharmaceutical carriers, emulsifies, encapsulates, embedding Or prepared by the technique such as lyophilized, active ingredient (Chinese medicine composition or Chinese medical extract) dilution of the invention or encapsulate wherein (see Remington ' s Pharmaceutical Sciences, the 15th edition, Hoover, J.E. chief editors, Mack Publishing Co.(2003))。

Above-mentioned formulation can take any suitable administering mode, which include it is local, through eye, oral, whole body, intranasal, The approach such as injection, transdermal, rectum, vagina, or suction or the form for being blown into administration.

For local administration, medicine of the invention can be made into solution, gel, ointment, emulsifiable paste, suspension etc..

Systemic formulations are included by drug administration by injection, for example subcutaneously, intravenous, intramuscular, intrathecal or intraperitoneal injection agent Type, and for transdermal, transmucosal oral cavity or the formulation of pulmonary administration.

Injectable dosage formulations include sterile suspensions, solution or emulsion of the medicine of the present invention in aqueous or oiliness medium. The formulation can also contain suspending agent, stabilizer and/or dispersant etc..Injection type can be provided with unit dosage forms, for example, in peace In small jar or in multidose container, preservative can be contained.

The form of powder is also may be selected in injectable dosage formulations, and suitable medium is being used using preceding, including but not limited to without Bacterium is prepared again without heat source water, buffer solution, glucose solution etc..Injectable dosage formulations can by being directly injected intravenously, vein it is fast Fast dropleting medicine-feeding, or be transfused by adding infusion solution such as 0.9% sodium chloride injection or other compatible infusion solution Administration.

For being administered orally, pharmaceutical excipient and/or the additive system by way of conventional can be used in medicine of the invention The standby formulation into such as lozenge, tablet or capsule.Liquid formulation for oral administration can take such as elixir, solution, syrup Agent or the form of suspension, or can be powder, prepared using preceding use water or other suitable mediums.This liquid Formulation can be prepared by way of conventional using medical additive.

Oral Preparation can be formulated into as controlled release formulation, and its preparation technology and method are known in the art 's.

The pharmaceutical dosage form of the present invention is preferably peroral dosage form or parenteral dosage form.Peroral dosage form includes tablet, capsule, ingot Agent, elixir, syrup, supensoid agent and powder etc., preferred tablet and capsule formulation.Parenteral dosage form includes injectable dosage formulations, bolt Agent and spray, preferably injection, freeze drying powder injection and parenteral solution etc..

The drug therapy purposes of the present invention

Chinese medical extract, Traditional Chinese drug mixture or the Chinese medicine composition (hereinafter referred to as " medicine of the invention ") of the present invention has Anti-inflammatory, antipyretic, spasmolysis, relieving asthma, antibechic, eliminating the phlegm, enhancing immune, antibacterium or at least one of antiviral effect, it can use Caused by the various causes of disease are treated cough, heating, expiratory dyspnea, spitting of blood, expectoration, out of breath, wheezing, pant, the clinical condition such as pectoralgia At least one of shape is a variety of.

From the perspective of the traditional Chinese medical science, clinical sign of the present invention includes hyperpyrexia, sweating and not understood, gas of coughing Anxious, nose incites rough, cough up phlegm yellow thick or coughs up rusty expectoration, and pectoralgia, thirsty agitation, dark urine is hard and dry.Red tongue with yellowish fur, arteries and veins Sliding number or big vast number.

The medicine of the present invention can be used for preparing treatment and/or prevent the medicine of at least one of following inflammation：Including Bio-pathogen is included caused by bacterium, fungi, virus, mycoplasma, Chlamydia, Legionella, Richettsia, Pneumocystis carinii etc. Inflammation, and inflammation caused by the abiotic pathogen factor.

In the present invention, bacterium is selected from least one of following bacterium：Staphylococcus aureus, MRSE, Streptococcus, Escherichia coli, micrococcus catarrhalis, klebsiella spp, Legionella, Pseudomonas aeruginosa, pneumococcus and proteus.

In the present invention, virus is selected from least one of following：Influenza virus (influenza virus (influenza Virus), Coxsackie virus, coronavirus (including causing the mutation (SARS virus) of lung typical pneumonia), measles virus, sidestream Influenza Virus (human parainfluenza virus (HPIVs), Respiratory Syncytial Virus(RSV), rhinovirus, adenovirus, herpesviral, giant cell disease Poison.

In a preferred embodiment of the invention, the inflammation is inflammation in respiratory system, including lung and respiratory tract (nasal cavity, Pharynx, larynx, trachea-bronchial epithelial cell) position such as pipe inflammation.

Classify according to the course of disease, inflammation in respiratory system of the present invention can include acute (branch) tracheitis, chronic (branch) Tracheitis, acute pneumonia, chronic pneumonia etc..

According to etiological classification, the inflammation in respiratory system referred in the present invention can include：

1. inflammation in respiratory system caused by bio-pathogen, including：

(1) bacterial inflammation such as streptococcus pneumonia, staphylococcus aureus, α-hemolytic streptococcus, kerekou pneumonia is white Inflammation caused by bacillus, haemophilus influenzae, pseudomonas aeruginosa etc..

(2) inflammation as caused by Legionella, mycoplasma and Chlamydia etc. of the inflammation caused by atypical pathogens.

(3) viral inflammation inflammation as caused by coronavirus, adenovirus, influenza virus etc..

(4) fungoid inflammation inflammation as caused by candida albicans, aspergillus, radiation bacterium etc..

(5) inflammation as caused by Richettsia, Infection of Toxoplasma Gondii, protozoon etc. of the inflammation caused by other pathogen；

2. inflammation in respiratory system caused by the abiotic pathogen factor.Including

(1) chemical inflammatory etc. as caused by radioactive inflammation, hydrochloric acid in gastric juice suction, medicine etc. of the inflammation caused by chemical factors. The chemical factors include 1) chemical substance, including endogenous and xenobiotics.It is xenobiotics such as strong acid, strong Alkali and turpentine oil, mustard gas etc.；Endogenous chemicals include the catabolite of toxicant such as slough and in some diseases Internal metabolite such as urea etc. is piled up under the conditions of reason；2) physical agent, including high temperature, low temperature, radioactive substance and purple Outside line etc. and mechanical damage etc.；3) foreign matter, i.e., enter the foreign matter of human body, such as various metals, wood chips, dirt by all means Angstrom particle and sutures etc., because its antigenicity is different, can cause different degrees of inflammatory reaction.

(2) slough：The reason such as ischemic or anoxic can cause necrosis, and necrosis be it is potential cause it is scorching because Son, the infiltration of the congested bleeding band and inflammatory cell that occur in fresh infarct range edge is all the performance of inflammation.

(3) allergy：I.e. when organism immune response abnormal state, inappropriate or excessive immune response can be caused, Cause tissue and cellular damage and cause inflammation.Tissue damage caused by immune response is most commonly in various types of super quick anti- Should：I allergic reaction types such as allergic rhinitis, nettle rash, for example anti-substrate membranous glomerulonephritis of II allergic reaction types, type III become State reacts the glomerulonephritis as caused by immune complex deposit, IV allergic reaction types such as tuberculosis, typhoid fever etc.；Permitted in addition, also having Many autoimmune diseases such as lymphocytic thyroiditis, ulcerative colitis.

Clinical symptoms and sign

The partial clinical symptom being related in the brief description present invention and clinical sign：

Cough：The excitant dry cough of acute attack occur together heat, trachyphonia person, be common in acute laryngitis, tracheitis, bronchus It is scorching；Cough all the year round, autumn and winter aggravates, and considers chronic bronchitis more；Cough, expectoration aggravation, expand in bronchus during Body Position Change Or pulmonary abscess in it is common；Cough is more common in pneumonia, pleurisy with pectoralgia；Ictal dry cough (especially being broken out in night rule), Point out CVA；Loud and sonorous dry cough is probably that lung bronchogenic carcinoma involves tracheae or main bronchus with expiratory dyspnea； The irritable cough for continuing and gradually aggravating then considers idiopathic pulmonary interstitial fibrosis or bronchovesicular cancer with shortness of breath.

Expectoration：Character, amount and the smell of phlegm have certain help to diagnosis.General phlegm switchs to purulence by white foam or mucus shape Property is generally bacterial infection；A large amount of yellowish purulent sputums are common in pulmonary abscess or bronchiectasis；Iron rust sample phlegm is probably streptococcus pneumonia Infection；Rufous gel-shaped phlegm often points out bacillus canalis capsulatus to infect；During with anaerobic infection, phlegm foul smelling taste；Edema with the lung involved When swollen, pink thin frothy sputum is coughed；Pulmonary amebiasis is in coffee sample phlegm；Paragonimiasis is jam phlegm.The increase and decrease of amount of expectoration, instead Reflect the aggravation of infection or the alleviation of inflammation.

Spitting of blood：Often it is the common sympton of pulmonary tuberculosis lung cancer with blood in phlegm.Cough up blood (particularly 24 hours 300 milliliters with On), bronchiectasis is more common in also seen in pulmonary tuberculosis；Acute bronchitis, pneumonia, pulmonary embolism, caused by mitral stenosis Pulmonary venous pleonaemia can also spit blood, but all be short-term.

Expiratory dyspnea：Expiratory dyspnea is mainly manifested in terms of respiratory rate, depth and the rhythm and pace of moving things.It is divided into by its speed that breaks out Acute, chronic and repeated relapsing.Acute shortness of breath often points out pneumonia, pneumothorax, pleural effusion with pectoralgia；Chronic progressive shortness of breath is shown in In COPD, diffusivity pulmonary interstitial fibrosis；During bronchial asthma attack, often there is expiratory dyspnea, And with wheezing sound, can be wholly absent during alleviation, symptom occurs again during breaking-out next time.Expiratory dyspnea is divided into inspiratory, expiration With three kinds of Combination.When laryngeal edema, laryngotracheitis disease, tumour or foreign matter cause the upper respiratory tract narrow, there is inspiratory stridor Sound；Asthma or asthmatic bronchitis cause the extensive bronchial spasm of lower respiratory tract, then cause expiration wheezing sound.With sun from The chitin of son, is combined in enteron aisle with fat and bile acid, can block fat digestion and absorption, and clear cholagogic road, reduction is neutral Fat and low-density lipoprotein, thrombus, prevent artery sclerosis and headstroke.

Pectoralgia：Lung and visceral pleura are insensitive to the pain sensation, and the lesion such as pneumonia, pulmonary tuberculosis, pulmonary infarction, pulmonary abscess involves parietal layer During pleura, can occur pectoralgia.Pectoralgia is considered as pneumonia with hyperpyrexia.When cancer is invaded and when partial pleura or rib, there is secret anguish, hold Continuous aggravation, or even cutting pains；Pleurisy often causes pectoralgia under the larger both sides of thorax activity, relevant with cough, deep air-breathing； When play is coughed or is held one's breath suddenly severe pain can occur for spontaneous pneumothorax.

Tcm clinical practice sign：From the perspective of the traditional Chinese medical science, table heresy is not understood and in entering, the strongly fragrant lung of heat symptoms caused by an exopathgen, lung defends closing, and sees height Heat is not moved back, no relieving of symptom after perspiration；Heat symptoms caused by an exopathgen stop up resistance lung qi, lung qi obstruction, therefore it is out of breath to cough, and nose incites rough, phlegm Huang or rust；Thermal burn lung Network then pectoralgia；Heat consuming body fluid and see thirsty, dark urine is hard and dry；And red tongue with yellowish fur, slippery and rapid pulse or big vast number are that heat symptoms caused by an exopathgen are stopped up Lung is levied.

Disease is summarized

Bacterial inflammation：Bacterial pneumonia (bacterialpneumonia) accounts for the 80% of all kinds of pathogen pneumonia of adult. Since the antibiotic epoch, the prognosis of bacterial pneumonia was once significantly improved, but case fatality rate residence height does not drop from after the sixties. By anatomical classification, pneumonia can be divided into great Ye, lobular and chromic fibrous.By etiological classification, main infectious and physics and chemistry Such as radioactive ray, poison gas, medicine and allergy such as hylactic pneumonia, the clinical findings overwhelming majority is bacterium, virus, clothing Infectious pneumonia caused by substance, mycoplasma, Richettsia, fungi and parasite etc., wherein most commonly seen with bacterium.

The pathogen of pneumonia is because of age, with disease and immune functional state, acquisition pattern (community acquired pneumonia Or nosocomial pneumonia in patients) and have larger difference.The common causative of community acquired pneumonia is streptococcus pneumonia, the bloodthirsty bar of influenza Bacterium, staphylococcus aureus, micrococcus scarlatinae, Legionella, anaerobic bacteria and virus, mycoplasma and Chlamydia etc., and hospital Then with Pseudomonas aeruginosa and the golden Portugal of other pseudomonads, pneumobacillus, Escherichia coli, proteus, methicillin-resistant in interior pneumonia Bacterium (mrsa) and fungi etc. are common.Most of aspiration pneumonia is anaerobic infection.

Inducements such as bacterial pneumonia patient Chang You catches cold, fatigue or with the basic disease such as chronic obstructive pulmonary disease, heart failure There is infection of the upper respiratory tract history before disease, 1/3rd diseases.Most onsets are more anxious.Part gram negative bacillus pneumonia, the elderly Pneumonia, the concealment of nosocomial pneumonia in patients onset.Heating is common, mostly lasting hyperpyrexia, and heat type can not be true to type after antibiotic therapy.Cough, Expectoration.Staphylococcus aureus under microscope is a lot of, is in early days dry cough, gradually there is expectoration, and how much amount of expectoration differs.Being in purulence sputum more Property, the more typical phlegm of S. aureus L-forms pneumonia is yellow purulence；Pneumococcal pneumonia is rusty expectoration；Klebsiellar pneumonia is brick red Color is viscous to freeze sample；Pyocyanic pneumonia is in light green；Anaerobic infection is often with stink.Above-mentioned typical phlegm is developed to after antibacterial therapy Liquid performance is rare.Spitting of blood is rare.There is pectoralgia part, is in then prickling-like pain when involving pleura.Inferior lobe pneumonia stimulates pleura diaphragmatica, Pain can be radiated to shoulder or belly, and the easy mistaken diagnosis of the latter is acute abdomen.Constitutional symptom has headache, DOMS, weak, and minority goes out The gastrointestinal symptoms such as existing Nausea and vomiting, abdominal distension, diarrhoea.Patient with severe symptoms can have the nervous system disease such as the drowsiness, disturbance of consciousness, convulsions Shape.

Viral inflammation：Viral pneumonia (viral pneumonia) is, by upper respiratory tract infection, institute to be spread downwards The lung inflammation of cause.Can occur in the children and adult that immunologic function is normal or suppresses.This disease betides winter-spring season mostly, can Break out or distribute prevalence.Viral pneumonia is apsiration infection, by the droplet infection of person to person, mainly by upper respiratory tract diseases Caused by poison infection spreads downwards, often with tracheitis and bronchitis.In ARI, virus infection accounts for 90%, there is common Flu, pharyngitis, larynx-tracheitis and bronchitis, capillary bronchitis, baby's herpangina (herpangina) and popularity Pectoralgia (pleurodynia) etc..Cause the virus of pneumonia using influenza virus as common, other are parainfluenza virus, huge Cell virus, adenovirus, rhinovirus, coronavirus and some enteroviruses, such as COxsackie, echovirus, and simple blister The viruses such as rash, varicella-zoster, rubella, measles.Infant also often produces pneumonia by respiratory syncytial virus infection.Patient It can be infected simultaneously by more than one viruses, and often secondary bacterial infection, immunosuppressed host also Chang Jifa fungies and protozoan infection.

Fungoid inflammation：Cause fungi such as aspergillus, promise card bacterium, cryptococcus, the capsule histoplasmosis of inflammation in respiratory system Bacterium；Candida albicans, it is the bacterial parasite of oral cavity, skin, enteron aisle and vagina；Actinomyces, it is dental decayed tooth bacterial parasite.In vivo other Such as position fungal infection can also follow lymph or blood to lung, the actinomyces under neck, diaphragm in focus, and such is Secondary cases Pulmonary Fungal Infections.Fungal pneumonia is often secondary to infantile pneumonia, pulmonary tuberculosis, diabetes, blood disease etc.；Using antibiotic and Hormone etc. is main inducing, because penicillin plays the role of to stimulate Candida albicans excessive multiplication；Broad-spectrum antibiotic suppresses Endophytic bacteria, makes candida albicans lose the restriction of bacterium；Cortin can suppress internal immunologic function.It has Bronchopneumonia Various symptoms and sign, but onset is slow, and pneumonia occurs or aggravated in application antibiotic therapy more, can there is heating, coughs Acutely, phlegm is colourless gel-shaped, the even band trace of blood.Auscultation of lung can have middle fine bubbling rale.

Allergia inflammation：Hylactic pneumonia (hypersensitivitypneumonitis) is one group by different sensibiligens Caused non-asthmatic allergia pulmonary disease, with diffusivity interstitial inflammation for its pathological characters.System due to suction containing fungal spore, Allergic reaction caused by the organic matter dirt particle (μ of diameter ＜ 10) of bacterial product, animal protein or insect antigen, therefore Also known as extrinsic allergic alveolitis (extrinsicallergicalveolitis).Allergen is containing fungal spore, carefully The organic matter dust granules of bacterium product, animal protein or insect antigen.In acute person, the patient of sensitization can have hair originally Heat, chilly, cough and expiratory dyspnea, typically come across after contact antigen again 4~8 hours.Also it may occur in which apocleisis, nausea and vomit Tell.Auscultation of lung has detail inspiratory phase moist rales, and wheezing sound is not common.Depart from after antigen, symptom is typically within a few houres Improve, but recover to need several weeks completely, recurrent exerbation can cause pulmonary fibrosis.Subacute person hidden can attack morbidity, cough and expiratory dyspnea Last for days needs hospitalization to several weeks, the state of an illness person of continuing to develop.In chronic person, have difficulty in breathing after sexuality, cough, Weak and Body weight loss is up to the several months to several years.Disease can develop into respiratory failure.

The present invention will be further described by the following examples.Embodiment only be used for illustrate the present invention implementation and Effect, and the invention is not limited in any way.It is Chinese medicine, raw material, excipient, diluent mentioned in example below, auxiliary Material, reagent or other drugs etc., are commercially available prod except as otherwise noted.As do not illustrated, then it is mentioned that material " % " is weight %, and " part " is parts by weight.

[preparation embodiment]

Prepare embodiment 1

Raw material proportioning：

The taste of the above four, Chinese ephedra segment, plus 12 times of decoctings boil secondary, 1.5 hours every time, filtration, and filtrate is concentrated to dryness, standby With.Baikal skullcap root decoction pieces, plus 8 times of amount water, are decocted three times, 1 hour every time, collecting decoction was concentrated into 1/3 decocting liquid volume, plus 2mol/L Hydrochloric acid solution adjusts pH value to 4.0, stands 1 hour, removes the impurity of viscous paste；Supernatant is taken, then adds 2mol/L hydrochloric acid solutions PH value is adjusted to 2.0,30 minutes are incubated at 80 DEG C, 4 DEG C is put and stands 12 hours.Abandoning supernatant, precipitating the stirring that adds water makes to mix Outstanding, double gauze filters out impurity, after filtrate is to be precipitated, repeats and is washed with water to pH value more than 5.0, filtration, is deposited at 80 DEG C It is dried under reduced pressure, it is standby.Radix glycyrrhizae adds 12 times of amount decoctings to boil secondary, and 2 hours every time, collecting decoction, filtration, filtrate was concentrated into 1/2 body Product, adds the concentrated sulfuric acid and adjusts pH value to 2.0, standing is stopped when being separated out without yellow mercury oxide, puts 5 DEG C of refrigerated overnights, abandoning supernatant, Precipitation blunges washing to pH value weakly acidic pH, is dried under reduced pressure at 60 DEG C, standby.Oil of negundo chastetree is according to oil：Beta-schardinger dextrin：Water is 1: 8: 70 ratio, takes the beta-schardinger dextrin of respective amount, is added to the water, heating be allowed to be completely dissolved, put be cooled at room temperature 50 DEG C with Under, side stirring, side adds the volatile oil of prescription ratio, and continues to stir 1.5 hours at a constant temperature.Put 4 DEG C and stand 8 hours, take out Sediment is filtered to dry.Merge said extracted thing, add auxiliary material, particle is made, load capsule, produce.

Prepare embodiment 2

Raw material proportioning：Using the extraction dry powder of following Chinese medicines, weighed in following ratios：

Oil of negundo chastetree is included with betadex, other each raw materials are added, mixed, auxiliary material is added, particle is made, loads glue Capsule, is produced.

[test example]

The antitussive effect of the medicine of the present invention of experiment 1

Antitussive actions of the 1-1 to mouse

Summary ammoniacal liquor causes mouse cough, and experiment passes through number of times of being coughed in mouse cough incubation period and 3 minutes, observation The antitussive action of the medicine of the present invention.As a result show, medicine of the invention is small, in, that heavy dose of group is obviously prolonged cough is latent Phase and reduction cough number of times, P ＜ 0.05, P ＜ 0.01, P ＜ 0.001 are compared with control group.

Antitussive action of the medicine of the purpose observation present invention to ammoniacal liquor induced mice.

Test material

Medicine

(1) by reagent：The extract dry powder for preparing in embodiment 1 is prepared, below the also referred to as medicine of the present invention.

(2) Western medicine positive control hustazol tablet, 10mg/ pieces are produced, lot number by Beijing dawn medicine company Co., Ltd： 030619；Valid until 200606.

(3) Chinese medicine positive control GUILONG KECHUANNING JIAONANG, 1g (crude drug)/grain (0.3g powder), by Shanxi osmanthus, dragon medicine is limited Company produces, authentication code：Chinese medicines quasi-word Z-11；Batch number：040112；Valid until 2005.12.

Animal Kunming mouses 70, II grades, male and female half and half, 21.84 ± 1.21g of body weight is real by the Chinese Academy of Medical Sciences Institute of Botany offer, licensing numbering SCXK (capital) 2000-0006 are provided.

Animal feed formulation and nutrition

Rat maintain feed, by Beijing Australia of section pull together feed corporation,Ltd production, licensing numbering：Capital dynamic (2000) the No. 015.

Main component [Bei Jingying defends searching (1997) the 083rd]：

Moisture≤9.5%, ash content≤7.8%, protein >=7.8%, fat >=4.3%, crude fibre ＜ 11.0%, bad ammonia Acid >=1.39%, egg+light propylhomoserin 0.3-0.54%, calcium：1.0%th, phosphorus：0.54%th, folic acid 21.1mg/kg, vitamin A >= 11.4/kg, vitamin D >=98ug/kg, vitamin B complex 24.11-164mg/kg, heat：4.62 thermies/kg.

The rearing conditions of animal

Xiyuan Hospital, Chinese Medicine Academy of China's Experimental Animal Center barrier environment Rearing facility, licensing：SYXK (capital) 2003-0808.Room temperature：22-24 DEG C, relative humidity：40 ± 5%.

Reagent ammonium hydroxide Beijing Century Red Star chemical industry Co., Ltd produces, lot number：20030310.

Test method

Healthy mice 70 is taken, 7 groups are randomly divided into, (1) blank control group gives distilled water (25ml/kg)；(2) hustazol tablet Group (12mg/kg)；(3) Guilong Kechuanning Capsule group (2g crude drugs/kg)；(4) medicine small dose group (125mg crude drugs/kg) of the invention； (5) medicine middle dose group (250mg crude drugs/kg) of the invention；(6) drug bolus group (500mg crude drugs/kg) of the invention. Mouse once, for three days on end, 30 minutes after last dose, is inserted 500ml beakers by the daily volume gastric infusion with 25ml/kg, A cotton balls is inside put, 1ml syringes are drawn into ammoniacal liquor 0.2ml and inject cotton balls, beaker is inverted rapidly, the cough of observed and recorded mouse is dived Volt phase and the interior cough number of times of 3min, compare, t is examined between being organized.

Result of the test is shown in Table 1.

Table 1：Influence to mouse antitussive action

Note：Compared with control group^*P ＜ 0.05；^**P ＜ 0.01；^***P ＜ 0.001.

As seen from the table, medicine of the invention it is small, in, heavy dose of group and positive drug group mouse cough is triggered to ammoniacal liquor, It is obviously prolonged the cough latent period time and reduces cough number of times, being compared with control group has significant difference, respectively (P ＜ 0.05, P ＜ 0.01, P ＜ 0.001).

It is above-mentioned test result indicates that, medicine of the invention triggers mouse cough to ammoniacal liquor, is obviously prolonged cough latent period And reduce the effect of cough number of times.

Antitussive actions of the 1-2 to cavy

The spraying of summary citric acid causes guinea pig cough, and experiment passes through cough time in guinea pig cough's incubation period and 5 minutes Number, observes the antitussive action of the medicine of the present invention.As a result show, medicine of the invention, which has extension cough latent period and reduced, coughs Number of times, being compared with control group has significant difference, is respectively (P ＜ 0.05, P ＜ 0.01, P ＜ 0.001).

The spraying of purpose citric acid causes guinea pig cough, observes the antitussive action of the medicine of the present invention.

Test material

Medicine

(1) by reagent：Prepare the extract dry powder (hereinafter simply also referred to as " medicine of the invention ") prepared in embodiment 1.

(2) Chinese medicine control GUILONG KECHUANNING JIAONANG, 1g (crude drug)/grain (0.3g powder), by Guilong Medicine Co., Ltd., Shanxi Production, authentication code：Chinese medicines quasi-word Z-11；Batch number：040112；Valid until 2005.12.

(3) Western medicine control hustazol tablet, 10mg/ pieces, are produced, the date of manufacture by Beijing dawn medicine company Co., Ltd： 200306；Lot number：030619；Valid until 200606.

The purebred cavy of animal 70, I grades, male and female half and half, 235.53 ± 35.88g of body weight, by Beijing KeYu animal-breeding Center is provided, licensing numbering SCXK (capital) 2002-0005.

Reagent citric acid (citric acid), Beijing Chemical Plant's production, lot number：960904.

Apparatus air pump, 4 liter capacity glass bell jars, glass shower nozzle.

Test method

Cavy is passed through into glass shower nozzle by being only placed in the closed bell jar of 4L containers with the pressure of (400mmHg) before experiment 17.5% citric acid soln is sprayed into, is sprayed 1 minute, the cough number of times for recording cavy in 5 minutes is screened, cough number of times is less than 10 times person abandons, and selecting qualified cavy is used to test.Qualified cavy 70 after screening is taken, male and female half and half are randomly divided into 7 groups, (1) blank control group gives distilled water (5ml/kg)；(2) hustazol tablet group (7mg/kg)；(3) Guilong Kechuanning Capsule (1.2g crude drugs/kg)； (4) medicine small dose group (308mg crude drugs/kg) of the invention；(5) medicine middle dose group (154mg crude drugs/kg) of the invention； (6) drug bolus group (77mg crude drugs/kg) of the invention.With 5ml/kg volume gastric infusion once daily, for three days on end, Control group is to normal saline, 30 minutes after last dose, by cavy by the closed bell jar for only inserting 4L volumes, with The pressure of (600mmHg) sprays into 17.5% citric acid by glass shower nozzle, sprays 1 minute, and the cough of observed and recorded cavy is hidden Cough number of times, compare between being organized in phase and 5 minutes, t is examined.

Result of the test is shown in Table 2.

Table 2：Influence to cavy antitussive action

Note：Compared with control group^*P ＜ 0.05；^**P ＜ 0.01；^***P ＜ 0.001.

Test result indicates that, medicine of the invention is small, in, that heavy dose of group and positive drug group are obviously prolonged cough is latent Time phase and the effect for reducing cough number of times, being compared with control group has significant difference, is respectively (P ＜ 0.05, P ＜ 0.01, P ＜ 0.001).

The above results show that medicine of the invention can be obviously prolonged the cough latent period time and reduce the work of cough number of times With.

The phlegm-dispelling functions of the medicine of the present invention of experiment 2

Influences of the 2-1 to the phenol red expectoration amount of mouse

Summary experiment observes the expectoration effect of the medicine of the present invention by using the method for the phenol red expectoration method of mouse.As a result, The medicine of the present invention is small, in, heavy dose of group and positive drug group be obviously promoted the increased effect of secretory volume, compared with control group There is significant difference (P ＜ 0.05, P ＜ 0.01, P ＜ 0.001).Show, medicine of the invention has bright to the phenol red discharge rate of mouse It is aobvious to promote the increased effect of secretory volume.

Purpose mouse phenol red secretion test, observes the medicine of the invention discharge rate phenol red to mouse whether there is facilitation.

Test material

Medicine

(1) by reagent：Prepare the medicine of the extract dry powder prepared in embodiment 1, the referred to as present invention.

(2) Chinese medicine control GUILONG KECHUANNING JIAONANG, 1g (crude drug)/grain (0.3g powder), by Guilong Medicine Co., Ltd., Shanxi Production, authentication code：Chinese medicines quasi-word Z-11；Batch number：040112；Valid until 2005.12.

(3) Western medicine control Mucosolvin, 30mg/ pieces, German Boehringer Ingelheim International Co., Ltd's product, product batch number： 206362, lot number of the repackaged products：030307.

Reagent

(1) gram/bottle of phenol red 25, is produced by Beijing Chemical Plant, lot number：20001017.

(2) NaOH Beijing chemical reagents corporation produces, lot number：040901.

Animal ICR kinds mouse 70, SPF grades, male and female half and half, 19.03 ± 1.18g of body weight ties up tonneau China by Beijing and tested Zoo technical Co., Ltd provides, licensing numbering SCXK (capital) 2002-0003.

Instrument ultraviolet-uisible spectrophotometer, model UV-120-02, Japanese Shimadzu Corporation's product.

Test method

Healthy mice 70 is taken, 7 groups are randomly divided into, (1) blank control group gives distilled water (25ml/kg)；(2) Mucosolvin Group (16mg/kg)；(3) GUILONG KECHUANNING JIAONANG group (2g crude drugs/kg)；(4) medicine small dose group of the invention (125mg crude drugs/ kg)；(5) medicine middle dose group (250mg crude drugs/kg) of the invention；(6) drug bolus group of the invention (500mg crude drugs/ kg).With 25ml/kg volumes gastric infusion once daily, for three days on end, fasting be can't help after water, last dose to mouse abdomen before experiment Chamber injects 5% phenol red normal saline solution 500mg/kg, puts to death mouse after 30 minutes, and back of the body position is fixed, and cuts off neck center skin Skin, separates and cuts an osculum on tracheae, tracheae, polish No. 7 syringe needles are inserted into tracheal strips about 0.3cm, is ligatured with silk thread after fixing, 1ml syringes absorption 0.5ml physiological saline is rinsed into air flue 3 times repeatedly, flushing liquor is sucked in test tube, above method repeats 3 Time, added with 0.1m11mol/L NaOH in flushing liquor test tube, make liquid in alkalescence, in the UV-120-02 types that wavelength is 546nm Ultraviolet-uisible spectrophotometer determines optical density (OD) value, and standard curve is made with phenol red, and phenol red content is calculated according to standard curve (μ g/ml), compares between being organized, and t is examined.

Result of the test is shown in Table 3.

Table 3：Influence to the phenol red discharge rate of mouse

Note：Compared with control group；^*P ＜ 0.05；^**P ＜ 0.01；^***P ＜ 0.001.

As seen from the table, the medicine of the medicine present invention of the invention it is small, in, heavy dose of group and positive drug group have obvious rush Enter the increase of secretory volume, being compared with control group has significant difference (P ＜ 0.05, P ＜ 0.01, P ＜ 0.001).

Brief summary the above results show that medicine of the invention is obviously promoted secretory volume increase to the phenol red discharge rate phlegm of mouse Effect.

Influences of the 2-2 to rat capillary expectoration amount

Summary experiment is observed expectoration of the medicine of the present invention to rat and acted on by using capillary expectoration method.As a result table Bright, the medicine is obviously promoted the increased effect of secretory volume, respectively P ＜ 0.05, P ＜ 0.01, P ＜ to rat capillary expectoration amount 0.001。

Purpose capillary expectoration method, the medicine of the observation present invention whether there is the expectoration amount promoted to rat.

Test material

Medicine

(1) by reagent：Prepare the medicine of extract dry powder prepared by embodiment 1, the referred to as present invention.

(2) Chinese medicine control GUILONG KECHUANNING JIAONANG, 1g (crude drug)/grain (0.3g powder), by Guilong Medicine Co., Ltd., Shanxi Production, authentication code：Chinese medicines quasi-word Z-11；Batch number：040112；Valid until 2005.12.

(3) Western medicine control Mucosolvin, 30mg/ pieces, German Boehringer Ingelheim International Co., Ltd's product, product batch number： 206362, lot number of the repackaged products：030307.

Animal Wistar kinds rat 70, SPF grades, male and female half and half, 171.17 ± 21.66g of body weight, by Chinese medicine section Institute of lab animals of institute is provided, licensing numbering：SCXK (capital) 2000-0006.

Test method

Healthy rat 70 is taken, 7 groups are randomly divided into, (1) blank control group gives distilled water (10ml/kg)；(2) Mucosolvin Group (11mg/kg)；(3) GUILONG KECHUANNING JIAONANG group (1.5g crude drugs/kg)；(4) medicine small dose group (87.5mg/ of the invention kg)；(5) medicine middle dose group (175mg/kg) of the invention；(6) drug bolus group (350mg/kg) of the invention.Experiment When with 3.5% chloraldurate (10ml/kg) rat abdominal cavity anaesthetize, face upward position fix keep flat, cut skin of neck, separate tracheae, An aperture is pricked with injection needle between two cartilages at thyroid cartilage lower edge center, capillary glass tube one, glass fiber is inserted into Tubule long 5cm, it is interior through 0.8mm, it is inserted into capillary and just contacts inner surface of trachea, when capillary is full of, changes one again immediately, First determine before administration and give medicine by duodenum with 10ml/kg volumes after 1hr capillary expectoration amounts, 1hr, control group is to equivalent Physiological saline, 1 after observation administration, 2hr averagely secretory volumes per hour, the average secretory volumes of the 1hr before being administered are used as normal value, carried out Compare between group, t is examined.

Result of the test is shown in Table 4.

Table 4：To rat capillary expectoration method expectoration amount influence (N=10)

Note：Compared with control group；^*P ＜ 0.05,^**P ＜ 0.01,^***P ＜ 0.001.

As seen from the table, medicine of the invention it is small, in, 1h, 2h have obvious rush after heavy dose of group and the administration of positive drug group Enter the increase of rats breathing road secretory volume, being compared with control group has significant difference, respectively P ＜ 0.05, P ＜ 0.01, P ＜ 0.001。

Brief summary the above results show that medicine of the invention is obviously promoted the increased effect of secretory volume to rats breathing road.

The antiasthmatic effect of the medicine of the present invention of experiment 3

The 3-1 effects relievingd asthma asthmatic to cavy caused by histamine+acetylcholine

Drug entities amine+the acetylcholine acted on by bronchoconstriction of making a summary sucks cavy with aeroponics, causes globefish Mouse is short of breath, and is panted, is even suffocated, so as to cause cavy to twitch, fall.Using this model, the medicine pair of the present invention is observed The antiasthmatic effect of cavy.As a result, medicine of the invention it is small, in, heavy dose of group and positive drug group be to acecoline+phosphoric acid group Cavy caused by knitting ammonia, which pants, can be obviously prolonged pant incubation period and tumble time, and (P ＜ 0.05, P ＜ 0.01, P are compared with control group ＜ 0.001).Show, medicine of the invention, which causes cavy to pant histamine induction, obvious antiasthmatic effect.

The medicine of the purpose observation present invention is to the antiasthmatic effect that causes cavy to pant caused by histamine.

Test material

Medicine

(1) by reagent：Prepare the medicine of extract dry powder prepared by embodiment 1, the referred to as present invention.

(2) Chinese medicine control GUILONG KECHUANNING JIAONANG, 1g (crude drug)/grain (0.3g powder), by Guilong Medicine Co., Ltd., Shanxi Production, authentication code：Chinese medicines quasi-word Z-11；Batch number：040112；Valid until 2005.12.

(3) Western medicine control aminophylline, 0.1g/ pieces, Zizhu Pharmaceutical Co., Ltd., Beijing's product, lot number：20031202.

The purebred albino guinea-pig of animal, I grades, male and female half and half, 169.37 ± 22.79g of body weight, by Beijing KeYu animal-breeding Center is provided, licensing numbering：SCXK (capital) 2002-0005.

Reagent

(1) acecoline 1g/ bottles, Beijing chemical reagents corporation, lot number：030211.

(2) histamine phosphate 5g/ bottles, Chinese Academy Of Sciences, Shanghai Institute Of Biology, production numbering：1702.

Instrument, which draws, breathes heavily device：Air compressor, glass aerosol shower nozzle, 4L glass bell jars.

Test method

Take healthy guinea pig, male and female half and half, in advance screening.By cavy by being only put into 4L glass bell jars, with (400mmHg) Pressure sprays into 2% acecoline and 0.1% histamine phosphate's equivalent mixed liquor, sprays 20 seconds.After spraying stops, observation There is the incubation period (time of asthmatic tic occur after stopping from spraying) of asthmatic tic in cavy in 6 minutes, asthmatic 120 seconds incubation periods ＞ person that twitches does not select.Take and screen qualified cavy 70, be randomly divided into 7 groups, every group 10, (1) control group Give distilled water (5ml/kg)；(2) aminophylline group (0.05g/kg)；(3) GUILONG KECHUANNING JIAONANG group (1.2g crude drugs/kg)；(4) originally The medicine small dose group (77mg crude drugs/kg) of invention；(5) medicine middle dose group (154mg crude drugs/kg) of the invention；(6) this hair Bright drug bolus group (308mg crude drugs/kg).With 5ml/kg volumes gastric infusion once daily, for three days on end, control group is given 30 minutes after normal saline, last dose, progress, which is drawn, breathes heavily experiment.By cavy by being only put into 4L glass bell jars, with The pressure of (400mmHg) sprays into the histamine phosphate's equivalent mixed liquor of 2% acecoline+0.1% and sprayed 20 seconds, observation 6 There is the incubation period (also known as asthmatic latent period) of asthmatic tic in (360 seconds) cavy in minute, i.e., after spraying stops, breathing heavily Time and the time of dropping to that breath property is twitched, calculated, compared between experimental result group with 360 seconds more than 6 minutes, t is examined.

Result of the test is shown in Table 5.

Table 5：Cavy caused by acetylcholine+histamine phosphate is panted effect influence (n=10,)

Note：Compared with control group：^*P ＜ 0.05；^**P ＜ 0.01；^***P ＜ 0.001.

From upper table result, medicine of the invention is small, in, heavy dose of group and positive drug group be to acecoline+phosphorus Cavy caused by acid tissue ammonia is panted and can be obviously prolonged pant incubation period and tumble time, and P ＜ 0.05, P ＜ are compared with control group 0.01st, P ＜ 0.001.

Brief summary test result indicates that, medicine of the invention is to cavy caused by caused by acecoline+phosphoric acid tissue ammonia Panting has obvious antiasthmatic effect.

The spasmolysis of the medicine of the present invention of experiment 4

4-1 is tested cavy allergic bronchospasm

Summary after 14 days, is sprayed by intramuscular injection ovalbumin and intraperitoneal injection pertussis vaccine sensitization with ovalbumin Mist method sucks cavy, forms guinea pig bronchial spasm, causes tumble of having difficulty in breathing, twitch, so as to cause cavy dead.Utilize This model, observes spasmolysis of the medicine to cavy allergic bronchospasm of the present invention.As a result show, medicine of the invention It is small, in, heavy dose of group and positive drug group can extend allergic bronchospasm incubation period, expiratory dyspnea and tic tumble time, Animal dead number is reduced, being compared with control group has significant difference (P ＜ 0.05, P ＜ 0.01, P ＜ 0.001 respectively), heavy dose of Group and positive drug group animal dead number are compared with control group significant difference (P ＜ 0.05, P ＜ 0.001 respectively).

The medicine of the purpose observation present invention causes the improvement result of cavy allergic bronchospasm to ovalbumin.

Test material

Medicine

(1) by reagent：Extract prepared by embodiment 1 is prepared, experiment uses its extract powder, is diluted to required concentration, calls in the following text The medicine of the present invention.

(2) Chinese medicine control GUILONG KECHUANNING JIAONANG, 1g (crude drug)/grain (0.3g powder), by Guilong Medicine Co., Ltd., Shanxi Production, authentication code：Chinese medicines quasi-word Z-11；Date of manufacture：2004.01.01；Batch number：040112；Valid until 2005.12。

(3) Western medicine control aminophylline, 0.1g/ pieces, Zizhu Pharmaceutical Co., Ltd., Beijing's product, lot number：20031202.

The purebred albino guinea-pig of animal, I grades, male and female half and half, 202.99 ± 12.98g of body weight, by Beijing KeYu animal-breeding Center is provided, licensing numbering：SCXK (capital) 2002-0005.

Reagent

(1) antigen：50g/ bottles of ovalbumin, Sigma (divides), Cat；A5253, the kindness scientific ＆ trading Co., Ltd. difficult to understand in Beijing.

(2) adjuvant：Pertussis vaccine 30,000,000,000/ml/2ml/ branch, Nat'l Pharmaceutical ＆ Biological Products Control Institute, lot number：04-1.

Instrument, which draws, breathes heavily device：Air compressor, glass aerosol shower nozzle, 4L glass bell jars.

Test method

Experiment is carried out in two steps, first by cavy sensitization.Take the white purebred cavy 70 of health, every cavy hind leg muscle note Ovalbumin 4mg (4% ovalbumin physiological saline 0.1ml) is penetrated, while pertussis vaccine 2 × 10 is injected intraperitoneally¹⁰Thalline sensitization, It is used to test within 14 days after injection.Animal is randomly divided into 7 groups, every group 10, (1) blank control group, to steaming during sensitization the 10th day Distilled water (5ml/kg)；(2) aminophylline group (0.05g/kg)；(3) GUILONG KECHUANNING JIAONANG group (1.2g crude drugs/kg)；(4) it is of the invention Medicine small dose group (77mg crude drugs/kg)；(5) medicine middle dose group (154mg crude drugs/kg) of the invention；(6) it is of the invention Drug bolus group (308mg crude drugs/kg).Simultaneously with 5ml/kg volume gastric infusions, once a day, continuous 5 days, control group was given 30 minutes after normal saline, last dose, by cavy by being only placed in 4L closed glass bell jars, with constant pressure (400mmHg) Sprayed into for 5% egg albumin solution half a minute, observe and record in 6 minutes (360 seconds) cavy occur asthmatic tic incubation period, Expiratory dyspnea, twitch tumble and dead animal number.Apnea is difficult and without tic tumble person, is calculated with 360 seconds.Experimental result is entered Compare between row group, t is examined.Dead animal number card side X²Examine.

Result of the test is shown in Table 6.

Table 6：To guinea pig bronchial spasm caused by ovalbumin influence (n=10 ()

Note：Compared with control group：^*P ＜ 0.05；^**P ＜ 0.01；^***P ＜ 0.001.

From upper table result, medicine of the invention is small, in, heavy dose of group and positive drug group can extend allergic bronchial Spasm incubation period, expiratory dyspnea and tic tumble time, animal dead number is reduced, being compared with control group has significant difference (to divide Other P ＜ 0.05, P ＜ 0.01, P ＜ 0.001), heavy dose of group and positive drug group animal dead number are compared with control group conspicuousness Difference (P ＜ 0.05, P ＜ 0.001 respectively).

Brief summary test result indicates that, medicine of the invention is small, in, heavy dose of group there is extension allergic bronchospasm to dive Fu Qi, expiratory dyspnea and tic tumble time effect, reduce animal dead number, allergic bronchial convulsion are caused to ovalbumin Contraction is significantly improved.

The antiinflammatory action of the medicine of the present invention of experiment 5

Rat paw edema inflammatory model caused by the medicine Carrageenan of this Germicidal efficacy present invention, as a result shows, The medicine of the present invention is small, in, heavy dose of group cause it is scorching after 0.5,1,2,4,6 hours different time points have and substantially suppress inflammation and swell Swollen effect, being compared with control group has significant difference (P ＜ 0.05, P ＜ 0.01, P ＜ 0.001).

5-1 paraxylene induces the swollen influence of mouse ear

The medicine paraxylene for this Germicidal efficacy present invention that makes a summary induces the red and swollen inflammatory model of mouse ear, experiment knot Really, medicine of the invention it is small, in, heavy dose of group and positive drug group paraxylene induced mice ear inflammation have and substantially suppress to make With mouse right ear swelling substantially mitigates, and being compared with control group has significant difference (difference P ＜ 0.05, P ＜ 0.01, P ＜ 0.001).Test result indicates that, each administration group paraxylene of medicine of the invention, which induces the red and swollen model of mouse ear, to be had preferably Antiinflammatory action.

The medicine paraxylene of the purpose observation present invention induces the antiinflammatory action of the swollen model of mouse ear.

Test material

Animal Male Kunming strain mice 70,25.06 ± 1.14 grams of body weight, is tested dynamic by the Chinese Academy of Medical Sciences by II grades Thing research institute breeding field is provided, licensing numbering：SCXK (capital) 2000-0006.

Medicine

(1) by reagent：Extract dry powder prepared by embodiment 1 is prepared, the medicine of the present invention is called in the following text.

(2) Chinese medicine control GUILONG KECHUANNING JIAONANG, 1g (crude drug)/grain (0.3g powder), by Guilong Medicine Co., Ltd., Shanxi Production, authentication code：Chinese medicines quasi-word Z-11；Batch number：040112；Valid until 2005.12.

(3) Western medicine control aspirin enteric coated tablet, every 0.3g is produced, lot number by Yantai No.2 Pharmaceutical Factory：011102. Said medicine is assigned into required concentration with distilled water when testing.

Test method

Healthy mice 70 is taken, 7 groups, every group 10 are randomly divided into.(1) control physiological saline group (25ml/kg)；(2) Ah This woods group (0.2g/kg)；(3) GUILONG KECHUANNING JIAONANG group (2g crude drugs/kg)；(4) medicine small dose group of the invention (125mg/kg)；(5) medicine middle dose group (250mg/kg) of the invention；(6) drug bolus group (500mg/ of the invention kg).With 25ml/kg volumes gastric infusion once daily, successive administration 3 days, control group is to normal saline.Given in the 3rd day Dimethylbenzene 0.05ml drops were put to death into animal in dislocation after mouse right ear, 15 minutes in 30 minutes after medicine, with 6mm card punch along left and right ear Wide same area punching, both sides auricle electronic scale is weighed respectively, and it is swelling again that the auris dextra piece per mouse subtracts left auricle again (mg) ear swelling degree (mg) compares between, being organized, and t is examined.

Result of the test is shown in Table 7.

Table 7：Swollen influence (the n=10 of the medicine paraxylene induced mice ear of the present invention)

Note：Compared with control group^*P ＜ 0.05；^**P ＜ 0.01；^***P ＜ 0.001.

It is as shown in the table, control group mice auris dextra obvious tumefaction, and thickness increase, two auricle differences are obvious.The medicine of the present invention It is small, in, heavy dose of group and positive drug group paraxylene induced mice ear inflammation have obvious inhibiting effect, mouse right ear swelling is bright Aobvious to mitigate, being compared with control group has significant difference (P ＜ 0.05, P ＜ 0.01, P ＜ 0.001 respectively).Test result indicates that, this Each administration group paraxylene of medicine of invention, which induces the red and swollen model of mouse ear, preferable antiinflammatory action.

Brief summary

Test result indicates that, in medicine of the invention, heavy dose of group paraxylene induce the red and swollen inflammatory model of mouse ear There is obvious inhibiting effect.

The influence of rat paw edema caused by 5-2 Carrageenans

Make a summary this Germicidal efficacy the present invention medicine Carrageenan caused by rat paw edema inflammatory model, as a result Show, medicine of the invention is small, in, heavy dose of group cause it is scorching after 0.5,1,2,4,6 hours different time points have obvious suppression The effect of inflammation swelling, being compared with control group has significant difference (P ＜ 0.05, P ＜ 0.01, P ＜ 0.001).

The antiinflammatory action of rat paw edema model caused by the medicine Carrageenan of the purpose observation present invention.

Test material

Medicine

(1) by reagent：Prepare the medicine of extract dry powder prepared by embodiment 1, the referred to as present invention.

(2) Chinese medicine control GUILONG KECHUANNING JIAONANG, 1g (crude drug)/grain (0.3g powder), by Guilong Medicine Co., Ltd., Shanxi Production, authentication code：Chinese medicines quasi-word Z-11；Batch number：040112；Valid until 2005.12.

(3) Western medicine control aspirin enteric coated tablet, every 0.3g is produced, lot number by Yantai No.2 Pharmaceutical Factory：011102. Said medicine is assigned to required concentration with distilled water when testing.

(5) carrageenan (CARRAGEENAN), SIGMA, lot number：117H0151,

Required concentration is configured to during experiment.

Animal Wistar kinds male white rat 70,157.05 ± 8.49 grams of body weight, one-level, by the Chinese Academy of Medical Sciences Institute of lab animals is provided, licensing numbering：SCXK (capital) 2000-0006.

Test method

Healthy rat 70 is taken, 7 groups are randomly divided into, (1) blank control group gives distilled water (10ml/kg)；(2) A Si Woods group (150mg/kg)；(3) GUILONG KECHUANNING JIAONANG group (1.5g crude drugs/kg)；(4) medicine small dose group of the invention (87.5mg/kg)；(5) medicine middle dose group (175mg/kg) of the invention；(6) drug bolus group (350mg/ of the invention kg).The left back sufficient volume (ml) of every animal is determined with capillary measurement by magnification method as value before medicine.Daily with 10ml/kg volumes Gastric infusion, once a day, successive administration 3 days, control group gives isometric physiological saline, will in 30 minutes after last dose 1% Irish moss is subcutaneously injected 0.05ml/ in rat left foot foot plantar and only causes inflammation, determine cause it is scorching after 0.5,1,2,4,6hr rats it is left back The volume (ml) of foot, so that comparing before and after scorching between difference group, t is examined.

Result of the test is shown in Table 8.

Table 8：Rat paw edema caused by Carrageenan influence (n=10,)

Note：Compared with control group：^*P ＜ 0.05；^**P ＜ 0.01；^***P ＜ 0.001.

It is as shown in the table, medicine of the invention is small, in, heavy dose of group and positive drug group cause it is scorching after 0.5,1,2,4,6 hours Different time points play the role of substantially to suppress the swelling of rat paw position, and being compared with control group has significant difference (P ＜ 0.05th, P ＜ 0.01, P ＜ 0.001).Brief summary

As a result show, medicine of the invention is small, in, rat paw edema inflammation caused by heavy dose of group Carrageenan have bright Aobvious inhibitory action.

The refrigeration function of the medicine of the present invention of experiment 6

Influence of the medicine of the 6-1 present invention to fever in rabbits caused by escherichia coli endotoxin

Summary experiment uses escherichia coli endotoxin pyrogenicity method, and rabbit auricular vein is injected with 250ng/ml/kg endotoxins Cause heating.As a result, reach peak within 3 hours, be gradually reduced within 6 hours.Aspirin group antipyretic effect is most obvious, and 1-6 is small after pyrogenicity When compared with control group and have significant difference (P 0.01~P of ＜ ＜ 0.001)；2-6 hours antipyretic effects after heavy dose group pyrogenicity Substantially, effect in 4 hours is stronger, shows (P 0.05~P of ＜ ＜ 0.01) with control group comparing difference；In, small dose group antipyretic effect not Substantially.Test result indicates that, drug bolus group of the invention has obvious refrigeration function to rabbit escherichia coli endotoxin pyrogenicity.

Purpose observes the medicine of the present invention to the antipyretic of rabbit after auricular vein Escherichia Coli Injection endotoxin pyrogenic Effect.

Test material

Medicine

(1) medicine of the invention：Prepare extract dry powder prepared by embodiment 1, concentration needed for being prepared during experiment.

(2) aspirin enteric coated tablet, 0.3g/ pieces, by Hunan, pharmaceutical factory produces, lot number：980808.

(3) Chinese medicine control GUILONG KECHUANNING JIAONANG, 1g (crude drug)/grain (0.3g powder), by Guilong Medicine Co., Ltd., Shanxi Production, authentication code：Chinese medicines quasi-word Z-11；Batch number：040112；Valid until 2005.12.

Pyrogen escherichia coli endotoxin, 500 micrograms/, institute of biological products of the Ministry of Public Health, lot number：891-2.

Animal large ear rabbit 56, female, male half and half, 1.95 ± 0.19kg of body weight, by Xueyaun Road, Haidian District, Beijing City tonneau Experimental animal plant provides, quality certification number：Capital is dynamic to be betrothed to (2000) No. 024 total No. 069.

Test method

Large ear rabbit is divided into 7 groups, every group 8, male and female half and half.(1) model control group gives physiological water (3ml/kg), (2) Aspirin group (100mg/kg), (3) GUILONG KECHUANNING JIAONANG (0.7g crude drugs/kg), the drug bolus group of (4) present invention (185mg/kg), the medicine middle dose group (92.5mg/kg) of (5) present invention, the medicine small dose group of (6) present invention (46.25mg/kg).Experiment uses escherichia coli endotoxin pyrogenicity method, experiment the previous day by rabbit by only determining anus body temperature twice, Average body temperature is taken as body temperature before medicine.Next day gastric infusion, once a day, successive administration 3 days, model control group gives to gavage ML normal saline, gastric infusion is once before endotoxin injection for aspirin group.Each administration group in 30 minutes after last dose, Through auricular vein Escherichia Coli Injection endotoxin 250ng/ml/kg, measure 1,2,3,4,5,6hr body temperature calculate each time point body The change (△ DEG C) of temperature, compares between being organized, and t is examined.

Result of the test

Table 9：The present invention medicine to rabbit body temperature influence (n=8,)

Note：Compared with control group^*P ＜ 0.05,^**P ＜ 0.01,^***P ＜ 0.001.

Itself compares：^#P ＜ 0.05；^##P ＜ 0.01；^###P ＜ 0.001.

As seen from the above table, 1 hour body temperature is begun to ramp up after control group pyrogenicity, is reached peak within 3 hours, is gradually reduced within 6 hours.Ah This woods group antipyretic effect is most obvious, and being compared with control group within 1-6 hours after pyrogenicity has significant difference (P 0.01~P of ＜ ＜ 0.001)；Substantially, effect in 4 hours is stronger for 2-6 hours antipyretic effects after heavy dose group pyrogenicity, with control group comparing difference significantly (P 0.05~P of ＜ ＜ 0.01)；In, small dose group antipyretic effect it is unobvious.

Brief summary

The drug bolus group of the present invention has indexed rabbit fever models to Escherichia coli endogenous toxic material obvious refrigeration function.

Influence of the medicine of the 6-2 present invention to rat yeast pyrogenicity

This experiment make a summary using rat yeast pyrogenicity method, the refrigeration function of the medicine of the present invention is observed.

2 hours temperature declines after experimental result, model control group pyrogenicity, begin to ramp up for 3 hours, and 4~5 reach peak, 6 hours It is gradually reduced.Substantially, compared with control group within 2-9 hours after pyrogenicity has significant difference (P ＜ to aspirin group antipyretic effect 0.01~P ＜ 0.001)；Substantially, compared with control group has significant difference (P to 3-7 hours antipyretic effects after heavy dose group pyrogenicity ＜ 0.05)；Compared with control group (P ＜ 0.05) within 3-5 hours after middle dose group pyrogenicity；Small dose group antipyretic effect is not obvious；Osmanthus Compared with control group (P ＜ 0.05) within 3-5 hours after imperial KECHUANNING JIAONANG group pyrogenicity；Test result indicates that, aspirin group, Gui Long The medicine of KECHUANNING JIAONANG group and the present invention are big, middle dose group has obvious refrigeration function to rat fever caused by yeast.As a result table Bright, medicine of the invention is big, middle dose group can obviously reduce rat temperature caused by yeast and raise, and has preferable refrigeration function.

Purpose induces pyrogenicity to rat skin lower injection yeast suspension, observes the medicine of the present invention to big

The refrigeration function of mouse.

Test material

Medicine

(1) medicine of the invention：Extract dry powder prepared by embodiment 1 is prepared, required concentration is configured to during experiment.

(2) aspirin enteric coated tablet, 0.3g/ pieces, by Hunan, pharmaceutical factory produces, lot number：980808.

(3) Chinese medicine control GUILONG KECHUANNING JIAONANG, 1g (crude drug)/grain (0.3g powder), by Guilong Medicine Co., Ltd., Shanxi Production, authentication code：Chinese medicines quasi-word Z-11；Batch number：040112；Valid until 2005.12.

Animal SD kinds rat 70, SPF grades, 189.5 ± 5.57g of body weight, male and female half and half are tieed up tonneau China by Beijing and tested Zoo technical Co., Ltd provides, licensing numbering SCXK (capital) 2002-0003.

Test method

Animal is randomly divided into 7 groups, every group 10, male and female half and half.(1) model control group gives physiology salt (10ml/kg)；(2) Aspirin group (0.15g/kg)；(3) GUILONG KECHUANNING JIAONANG group (1.5g crude drugs/kg)；(4) drug bolus group of the invention (350mg/kg)；(5) medicine middle dose group (175mg/kg) of the invention；(6) medicine small dose group (87.5mg/ of the invention kg).Test the previous day measure rat anus body temperature twice, take average body temperature as body temperature before medicine.Daily gastric infusion once, connects Continuous 3 days, model control group is to isometric physiological saline is gavaged, and each administration group was in 30 minutes after last dose, in rat back skin It is lower injection 15% yeast suspension (10ml/kg), aspirin group injection yeast suspension before gastric infusion once.Determine each Administration group 2,3,4,5,6,7,8,9hr rat temperatures, the 4hr after pyrogenicity, each administration group again gastric infusion once (dosage is the same), The change (△ DEG C) of each time point body temperature is calculated, is compared between being organized, t is examined.

Result of the test

Table 10：The present invention medicine to rat temperature influence (n=10,)

Note：Compared with model control group：^*P ＜ 0.05；^**P＜ 0.01；^***P ＜ 0.001.

Itself compares：^##P ＜ 0.01；^###P ＜ 0.001.

2 hours temperature declines after table, model control group pyrogenicity, begin to ramp up for 3 hours, and 4~5 reach peak, 6 hours It is gradually reduced.Substantially, compared with control group within 2-9 hours after pyrogenicity has significant difference (P ＜ to aspirin group antipyretic effect 0.01~P ＜ 0.001)；Substantially, compared with control group has significant difference (P to 3-7 hours antipyretic effects after heavy dose group pyrogenicity ＜ 0.05)；Compared with control group (P ＜ 0.05) within 3-5 hours after middle dose group pyrogenicity；Small dose group antipyretic effect is not obvious；Osmanthus Compared with control group (P ＜ 0.05) within 3-5 hours after imperial KECHUANNING JIAONANG group pyrogenicity；Test result indicates that, aspirin group, Gui Long The medicine of KECHUANNING JIAONANG group and the present invention are big, middle dose group has obvious refrigeration function to rat fever caused by yeast.

This experiment of brief summary uses yeast rat fever model, observes the refrigeration function of the medicine of the present invention.As a result show, The medicine of the present invention is big, middle dose group can obviously reduce rat temperature caused by yeast and raise, and has preferable refrigeration function.

The enhancing immunization of the Chinese medical extract of the present invention of experiment 7

Influences (nospecific immunity) of the 7-1 to mouse phagocytic function

Summary observes influence of the medicine of the present invention to mouse monokaryon cytophagy with Carbon grain Kuo clear law.As a result show Show, positive control drug levamisol and GUILONG KECHUANNING JIAONANG group phagocyte imdex are apparently higher than control group, with control group ratio Compared with P ＜ 0.05, P ＜ 0.01, drug bolus of the invention, middle dose group mouse phagocyte imdex are higher than control group, there is aobvious Sex differernce P ＜ 0.05, P ＜ 0.01 are write, shows the big medicine, middle dose group and positive control drug to nonspecific immunity of mice It is remarkably reinforced effect.

Purpose observes effect of the medicine of the present invention to mouse monokaryon cytophagy using Carbon grain Kuo clear law.

Test material

Medicine

(1) by reagent：Extract dry powder prepared by embodiment 1 is prepared, experiment is dense needed for extract powder is assigned to distilled water Degree.

(2) Chinese medicine control GUILONG KECHUANNING JIAONANG, 1g (crude drug)/grain (0.3g powder), by Guilong Medicine Co., Ltd., Shanxi Production, authentication code：Chinese medicines quasi-word Z-11；Batch number：040112；It is dense needed for being assigned to when 2005.12, experiment Degree.

(3) Western medicine control levamisole hydrochloride, 25mg/ pieces, BJ Pharmaceutical Co., Ltd. product, lot number：9608228.Match somebody with somebody during experiment To required concentration.

(4) chemical plant in india ink, West Beijing, lot number：820501.

Animal health ICR kinds mouse 70, SPF grades, male and female half and half, 19.21 ± 1.24 grams of body weight ties up tonneau by Beijing Magnificent experimental animal Technology Co., Ltd. provides, credit number SCXK (capital) 2002-0003.

Instrument ultraviolet-uisible spectrophotometer, model UV-120-02, Japanese Shimadzu Corporation's product.

Test method

Mouse 70 is taken, 7 groups are randomly divided into, every group 10, (1) control group gives distilled water (25ml/kg)；(2) left-handed miaow Azoles group (30mg/kg)；(3) GUILONG KECHUANNING JIAONANG group (2g crude drugs/kg)：(4) medicine small dose group (125mg/ of the invention kg)；(5) medicine middle dose group (250mg/kg) of the invention；(6) drug bolus group (500mg/kg) of the invention.Daily With 25ml/kg volumes gastric infusion once, continuous to give 7 days, control group gives 30 minutes use after same volume physiological saline, last dose 10% india ink 0.2ml/ only gives mouse tail vein injection.After injection 2 minutes and 10 minutes respectively eyeball rear vein beard take Blood 0.02ml, is added to lysed erythrocyte in the test tube equipped with 4ml distilled water, then in the UV-120-02 types that wavelength is 600nm Spectrophotometric determination optical density (OD) value, the speed K of the carbon particle clearance in serum within the unit interval is calculated by following equation.

OD2 and OD10 inject respectively after india ink 2 minutes and 10 minutes institute's blood samplings OD values, t2 and t10 is take blood Time.Compare between result of the test group, t is examined.

Result of the test the results are shown in Table 11.

Table 11：Influence (n=10 of the medicine of the present invention to mouse phagocytic function)

It is as shown in the table, and positive control drug levamisol and GUILONG KECHUANNING JIAONANG group phagocyte imdex are apparently higher than control Group, is compared P ＜ 0.05, P ＜ 0.01 with control group, and drug bolus of the invention, middle dose group mouse phagocyte imdex are high In control group, there are significant difference P ＜ 0.05, P ＜ 0.01, show that the big medicine, middle dose group and positive control drug are non-to mouse Specific immune function is remarkably reinforced effect.

Brief summary

With carbon particle clearance test method, influence of the medicine of the present invention to mice serum carbon particle clearance speed is observed.Experiment As a result, the medicine is remarkably reinforced effect to nonspecific immunity of mice.

Influences (cellular immunity) of the 7-2 to mouse Tardive allergy

Summary experiment causes mouse Tardive allergy model with DNF, observes the medicine of the present invention Effect to mouse Tardive allergy (DTH).Each dosage group of medicine of the present invention causes mouse to DNF Tardive allergy model mice ear swelling is not obvious, unobvious to spleen, thymus index change, is compared with control group without bright Significant difference is different.As a result show, the medicine suppresses or humidification to mouse Tardive allergy without obvious.

Purpose is by antigen of DNF to mouse sensitization, and the medicine of the observation present invention is attacked to receiving this antigen The effect of caused Tardive allergy (DTH) is hit, to inquire into influence of the medicine to mouse cell immunologic function.

Test material

Medicine

(1) by reagent：Extract dry powder prepared by embodiment 1 is prepared, experiment is dense needed for extract powder is assigned to distilled water Degree.

(2) Chinese medicine control GUILONG KECHUANNING JIAONANG, 1g (crude drug)/grain (0.3g powder), by Guilong Medicine Co., Ltd., Shanxi Production, authentication code：Chinese medicines quasi-word Z-11；Batch number：040112；It is dense needed for being assigned to when 2005.12, experiment Degree.

(3) Western medicine control levamisole hydrochloride：25mg/ pieces, BJ Pharmaceutical Co., Ltd. product, lot number：9608228.Match somebody with somebody during experiment To required concentration.

Animal health ICR kinds mouse 70, SPF grades, male and female half and half, 19.9 ± 0.84g of body weight ties up tonneau China by Beijing Experimental animal Technology Co., Ltd. provides, credit number SCXK (capital) 2002-0003.

Test method

Mouse 70 is taken, 7 groups are randomly divided into, every group 10, (1) control group gives distilled water (25ml/kg)；(2) left-handed miaow Azoles group (30mg/kg)；(3) GUILONG KECHUANNING JIAONANG group (2g crude drugs/kg)；(4) medicine small dose group (125mg/ of the invention kg)；(5) medicine middle dose group (250mg/kg) of the invention；(6) drug bolus group (500mg/kg) of the invention.Daily With 25ml/kg volumes gastric infusion once, continuous 8 days, control group gave same volume physiological saline, and control group is removed within the 3rd day in administration Outside, each administration group mouse is uniformly applied to sensitization 1 time at belly depilation, area about 3 with the μ l of 1%DNFB acetone olive oil solution 50 ×3(cm)², it is applied to mouse right ear two sides with the ibid μ l of antigen 10 in the 5th day each group animal after sensitization and is attacked.After attack 24h, mouse cervical dislocation is put to death, and cuts left and right auricular concha, and diameter 8mm auricle is removed with card punch, is weighed.Left and right auricle weight The difference of amount is swelling (FPR), to represent Tardive allergy (DTH) degree, while taking thymus gland, spleen to weigh, is counted Internal organs mg/10g body weight is calculated, is compared between as a result being organized, t is examined.

Result of the test the results are shown in Table 12.

Table 12：Influence (n=10 to mouse cell immunologic function)

Note：Compared with control group^*P ＜ 0.05；^**P ＜ 0.01.

It is as shown in the table, and each dosage group of medicine of the invention is to causing mouse Tardive allergy with DNF Model mice ear swelling is not obvious, unobvious to spleen, thymus index change, is compared no significant difference with control group.As a result table Bright, the medicine suppresses or humidification to mouse Tardive allergy without obvious.

Brief summary

In the method for Tardive allergy, effect of the medicine of the present invention to mouse Tardive allergy, knot are observed Fruit shows that the medicine suppresses or humidification to mouse Tardive allergy without obvious.

Influences (humoral immunity) of the 7-3 to mice serum agglutinin

Summary agglutinin method for measuring, observes influence of the medicine of the present invention to mouse humoral immune function.Knot Really, drug bolus group of the invention significantly increases the level of mice serum moderate resistance sheep red blood cell antibody and compared with control group P ＜ 0.05, P ＜ 0.01, and show obvious dose-effect relationship.Prompting, drug bolus group of the invention is improved mouse body fluid The effect of immunologic function.

Purpose observes the medicine of the present invention to mouse humoral immune function by the effect to mice serum agglutinin Influence.

Test material

Medicine

(1) by reagent：Extract dry powder prepared by embodiment 1 is prepared, experiment distilled water is dense needed for extract powder is prepared Degree.

(2) Chinese medicine control GUILONG KECHUANNING JIAONANG, 1g (crude drug)/grain (0.3g powder), by Guilong Medicine Co., Ltd., Shanxi Production, authentication code：Chinese medicines quasi-word Z-11；Batch number：040112；It is dense needed for being assigned to when 2005.12, experiment Degree.

(3) Western medicine control Content of Tablet of Levamisole Hydrochloride：25mg/ pieces, BJ Pharmaceutical Co., Ltd. product, lot number：9608228.

Animal ICR kind mouse, male and female half and half, SPF grades, 19.80 ± 0.79g of body weight ties up the magnificent experimental animal of tonneau by Beijing Technology Co., Ltd. provides, credit number：SCXK (capital) 2002-0003.

Test method

Mouse 84 is taken, 7 groups are randomly divided into, every group 12, (1) control group gives distilled water (25ml/kg)；(2) left-handed miaow Azoles group (30mg/kg)；(3) GUILONG KECHUANNING JIAONANG group (2g crude drugs/kg)；(4) medicine small dose group (125mg/ of the invention kg)；(5) medicine middle dose group (250mg/kg) of the invention；(6) drug bolus group (500mg/kg) of the invention.Daily With 25ml/kg volumes gastric infusion once, successive administration 7 days, after being administered 48 hours, the sheep red blood cell of mouse peritoneal injection 5% (SRBC) 0.25ml/ is only immunized, and blood is taken by eyeball rear vein beard within the 6th day after being immunized, and is centrifuged, and serum is separated, with micro Agglutination determines serum moderate resistance SRBC antibody titers.

Microhemagglutination test method：With physiological saline by serum two-fold dilution, the serum of various concentrations is drawn 25 μ respectively L is placed in Microhemagglutination plate hole, adds the μ l of 0.5%SRBC 25, and vibration is mixed, and is placed in the square position of moistening and is capped, is put into 37 It is incubated in DEG C insulating box, aggegation degree is observed after 3 hours, point 5 grades (0~4), by following equation calculating antibody product, experiment knot Fruit t is examined.

Antibody product=∑ (S₁+2S₂+3S₃+......nS_n)

1 in formula, 2,3......n represent the index of two-fold dilution, S represents the rank of aggegation degree, and antibody product is bigger, Represent that antibody titer is higher, T is examined between group.

Result of the test the results are shown in Table 13.

Table 13：Effect (n=12 of the medicine of the present invention to mice serum agglutinin)

Note：Compared with control group.

It is as shown in the table, and drug bolus group of the invention considerably improves mice serum moderate resistance sheep red blood cell antibody Level, is compared (P ＜ 0.05) with control group, and positive control drug levamisol and GUILONG KECHUANNING JIAONANG group also significantly improve small Antibody response (P ＜ 0.05) of the mouse to sheep red blood cell.Prompting, drug bolus group of the invention can improve mouse humoral immune work( Energy.

Brief summary

This experiment agglutinin method for measuring, the influence that observation medicine of the invention is reacted mouse humoral immune, knot Fruit shows, in medicine of the invention, heavy dose of group can significantly increase antibody response (P ＜ 0.05 of the mouse to sheep red blood cell ~P ＜ 0.01).Show in the medicine of the present invention, heavy dose of group is improved the effect of humoral immune function.

The antivirus action of the medicine of the present invention of experiment 8

Protective effects of the 8-1 to the viral mouse of infection FM1

Summary：The medicine gastric infusion of the present invention, observes protective effect of the medicine to the viral mouse of infection FM1, as a result table It is bright：The large, medium and small dosage of medicine of the present invention can reduce infection FM₁The death rate of animal is equal (P ＜ 0.01), during extension existence Between (P ＜ 0.001), heavy dose group virus infected mice Lung Exponent and intrapulmonary viral level reduction, with model group comparing difference Significantly (P ＜ 0.05).The medicine is pointed out to mitigate infecting mouse pulmonary lesion.

Purpose：Flu virus FM1 collunarium infecting mouses are used herein, set up viral pulmonary infection mouse mould Type, using Lung Exponent, the death rate and extension life span as index, observes protection of the medicine to viral pulmonary infection mouse and makees With.

Materials and methods

Medicine

1st, by reagent：Prepare embodiment 1 prepare extract dry powder, mouse dosage be 500,250,125mg/kg/ Day, be made into 50 with distilled water, 25,12.5mg/ml decoction it is standby.

2nd, medication is compareed：(1) GUILONG KECHUANNING JIAONANG, is produced by Guilong Medicine Co., Ltd., Shanxi.Authentication code：(89) Defend the quasi- word of medicine Z-11, product batch number：030101.Dosage is 2g crude drugs/kg/ days, and 0.2g/ml decoctions are made into distilled water It is standby.(2) Western medicine comparison medicine ribavirin injection, 100mg/ml is produced, authentication code by Beijing Yongkang pharmaceutical factory：State The quasi- word H19993335 of medicine, product batch number：03020137.Dosage is 70mg/kg/ days, and 7mg/ml decoctions are made into distilled water It is standby.

Influenza virus A-prime mouse lung adapted strain (FM1)：There is provided by Virology Inst., China Academy of Preventive Medicine Sciences, this Room night nitrogen is preserved.It is 1: 640 that chicken embryo, which passes on 2 times to increase Hemagglutination titer after poison, to mouse LD₅₀For 10^-4.44。

Chicken embryo：9 ages in days, are bought by upper village Ji Chang.

Animal KM kind mouse, two grades, 12~14 grams of body weight, male and female half and half, tieing up the magnificent experimental animal technology of tonneau by Beijing has Limit company buys, quality certification number：SCXK (capital) 2002-0003.

Experimental method：

1. mouse Lung Exponent and lung index are determined：Healthy mice 84, random point 7 groups, i.e., normal control (is given Water), virus control (feedwater), GUILONG KECHUANNING JIAONANG (560mg/kg), Ribavirin (70mg/kg) and by reagent it is big (500mg/kg), in (250mg/kg), small (125mg/kg) dosage group, each group 12, male and female half and half.Before each group animal self-infection With 10ml/kg gastric infusions or fed water totally 7 days to after infecting the 5th day, respectively within two days.In addition to normal group, each group mouse is in second Under ether light anesthesia, respectively with 15LD₅₀Virus 5 0ul collunariums infection, Normal group is with method collunarium physiological saline 50ul.Most Afterwards 24 hours after 1 administration, mouse is weighed, and it is lethal to pluck eyeball bloodletting, is taken out full lung with sterile working and is weighed, calculate Lung Exponent and Lung index.Mouse lung channel tissue homogenizer is homogenized, and 10% suspension, 2000 revs/min, centrifugation 10 are made into physiological saline Minute, take supernatant normal saline dilution 10^-1~10^-7, it is inoculated with 9 age in days chick embryo allantois intracavitary, 0.1ml/ embryos, per dilution factor 5 pieces of inoculation, 33 DEG C are cultivated 48 hours, determine hemagglutinative titer in chick embryo allantoic liquid, and half sense is calculated by Reed and Muench methods Contaminate concentration (EID₅₀)。

2. virus infected mice death protection and extending life experiment：Divide 7 groups, model group 30 at random healthy mice Only, remaining each group 20, both normal control, virus control, GUILONG KECHUANNING JIAONANG, Ribavirin and large, medium and small dose of by reagent Amount group.Medication is with experiment 1, and each group mouse is respectively with 10LD in addition to Normal group₅₀Viral collunarium infection after, see day by day Examine animal incidence and record death toll, totally 14 days, calculate Death prevention rate and extending life rate.

As a result

1. the influence of pair Lung Index of mice infected by Influenza virus and intrapulmonary viral level

(1) to the influence of Lung Index of mice infected by Influenza virus and intrapulmonary viral level, it the results are shown in Table 14-1.

Table 14-1：Effect to Lung Index of mice infected by Influenza virus

It is as shown in the table, virus infected mice lung enlargement, Lung Exponent (1.31 ± 0.25) be significantly more than normal group (0.91 ± 0.07) (P ＜ 0.001).The drug bolus group Lung Exponent of the present invention is substantially reduced, and Lung Exponent (1.1 ± 0.14) is with touching type group Significantly (P ＜ 0.05), lung index is 16.03% to comparing difference.Ribavirin group significantly reduce Lung Exponent (1.08 ± 0.09), with touching type group comparing difference significantly (P ＜ 0.01), lung index is 17.56%.GUILONG KECHUANNING JIAONANG does not have Obvious effect.

(2) to the influence of infecting mouse intrapulmonary viral level, it the results are shown in Table 14-2.

Table 14-2：Intrapulmonary viral level determines (blood clotting)

It is as shown in the table, mouse infection FM₁After virus, model group intrapulmonary viral level EID₅₀For 10^-5.85, and heavy dose of group EID₅₀For 10^-4.17, it is big compared with model group 4.5 times, Ribavirin group is compareed with Western medicine similar.

2. viral dead protection and extending life effect

Table 14-3：Virus infected mice death protection and extending life effect

Note：^**P ＜ 0.01^***P ＜ 0.001

It is as shown in the table, and virus infection each group mouse has death, and the virus control group death rate is 90%, mean survival time It is 35~45% for the large, medium and small dosage group death rate of 7.53 ± 2.52 days by reagents, is compared death toll with model group and significantly dropped Low (P ＜ 0.01), 10.9~11.7 days mean survival times and extending life rate 44.75~55.37% and virus control group ratio Relatively there were significant differences (P ＜ 0.001).The western medicine group death rate is 10%, 13.5 ± 1.57 days mean survival times and is prolonged Long vital rates 79.28% is compared with virus control group, and there were significant differences (P ＜ 0.001).GUILONG KECHUANNING JIAONANG is not as good as this hair Bright medicine.

Brief summary

The medicine of the present invention is pressed mouse of the various concentrations gavage to influenza virus infection FM1, the medicine is observed small to infecting The dead protective effect of mouse and the inhibitory action of pulmonary lesion.As a result show, the large, medium and small dosage group of the medicine can reduce infection (P ＜ 0.01), (P ＜ 0.001), heavy dose group Lung Exponent and model group are poor for extension life span for the death toll of animal Different notable (P ＜ 0.05), lung index 16.03%, intrapulmonary viral level illustrates the medicine in Mice Body than model group reduction Interior energy suppresses FM₁Virus replication, mitigates pulmonary lesion.

The experimental study of the Drug inhibition influenza virus effect of the 8-2 present invention

Summary：The medicine of the present invention uses Various medications, observes medicine infected by influenza first 3, the hepatitis B infection chicken embryo Protective effect, as a result show that the medicine infected by influenza has direct deactivation.

Purpose：Influenza virus A 3, hepatitis B infection chicken embryo are used herein, are set up virus infection and are touched type, with sick in chick embryo allantoic liquid Malicious content is the inhibitory action of the index observing medicine infected by influenza.

Materials and methods

Medicine

1. test medication：Traditional Chinese medicine extraction dry powder liquiritin, Chinese ephedra total alkali, scutelloside, oil of negundo chastetree press 2.5：1∶2.5∶0.04 Weight ratio be mixed with.

It is prepared by experimental drug：Add each dry powder after oil of negundo chastetree is dissolved in dimethyl sulfoxide (DMSO) to dissolve, total amount 4.5ml, Equivalent to 257mg/ml, 4 DEG C of refrigerators are put standby (medicine for calling the present invention in the following text).

2. compare medication：GUILONG KECHUANNING JIAONANG, 3g crude drugs/g medicinal powder, is produced by Guilong Medicine Co., Ltd., Shanxi.Batch Quasi- code：(89) the quasi- word of medicine Z-11, product batch number are defended：030101.

Prepared by experimental drug, take GUILONG KECHUANNING JIAONANG 3g medicinal powder, plus the dissolving of 20ml distilled water, and water-bath is boiled 20 minutes, 2000 revs/min after cool, centrifuge 10 minutes, take supernatant 14ml, equivalent to 0.7g crude drugs/ml, 4 DEG C of preservations use 5.6% before experiment NaHCO₃Adjust PH=7.2.

Virus

1st, the type of influenza first 3：The anti-95-359 chick embryo allantoic liquids of the Chinese.

2nd, influenza B：The anti-93-184 chick embryo allantoic liquids in capital.

There is provided by Virology Inst., China Academy of Preventive Medicine Sciences, with 50~100EID during experiment₅₀/0.1ml。

3rd, chicken embryo：Instar chicken embryo on the 9th~10, is provided by upper village Ji Chang.

Experimental method：

1. medicine is to the toxicity test of chicken embryo：By the decoction 0.1ml rows chick embryo allantoic cavity diluted inoculation, in 33 DEG C of incubators Culture 72 hours, daily observation chicken embryo is anyway.

2. medicine and viral equivalent neutralisation：The decoction diluted is neutralized with virus in test tube moderate；Put 33 DEG C of incubators 1 Hour, row chick embryo allantoic cavity inoculation 0.2ml.In 33 DEG C of incubator cultures.

3. dose regimen after first virus inoculation：0.1ml virus inoculations put 33 DEG C of incubators 1 hour in chick embryo allantoic cavity, then adopt The decoction 0.1ml diluted is injected with same approach, in 33 DEG C of incubator cultures.

Experiment does virus control simultaneously above, and chicken embryo is observed daily, and chance is extremely then removed.3 type culture of first 48 hours, B-mode training Support 72 hours, put after 4 DEG C of refrigerator overnights, take allantoic fluid to survey the difference of hemagglutinative titer (HA), comparative experiments group and virus control group. Half toxic concentration and half protection concentration (neutralization concentration) are calculated by Reed and muench methods.Formula is as follows：

As a result

1. medicine is to the toxicity test of chicken embryo

It the results are shown in Table 15-1.

Table 15-1：Toxicity test result of the medicine to chicken embryo

As shown in table 15-1, the maximal non-toxic concentration of medicine of the invention is 32.125mg/ml, and GUILONG KECHUANNING JIAONANG is most Big non-toxic concn is 700mg/ml.

2. medicine and the type equivalent neutralization of influenza virus A 3

It the results are shown in Table 15-2.

Table 15-2：Medicine and the type equivalent neutralization result (HA) of influenza virus A 3

As shown in table 15-2, medicine of the invention in the average half of the type of first 3 virus and concentration is 0.011mg/ml, in It is 6617.69 with index.GUILONG KECHUANNING JIAONANG is averaged in half and concentration is 9.47mg/ml, and neutralization index is 99.81.Can To neutralize the type of influenza first 3 virus completely.

3. medicine and the B-mode equivalent neutralization of influenza virus

It the results are shown in Table 15-3.

Table 15-3：Medicine and the B-mode equivalent neutralization result of influenza virus

As shown in table 15-3, medicine of the invention is averaged to influenza B virus in half and concentration is 0.018mg/ml, Neutralization index is 4022.2.GUILONG KECHUANNING JIAONANG is averaged in half and concentration is 236.46mg/ml, and neutralization index is 3.99. Influenza B virus can be neutralized completely.

4. medicine infected by influenza infects the protective effect of chicken embryo

It the results are shown in Table 15-4.

Table 15-4：Medicine infected by influenza infects the protective effect result of chicken embryo

It is as shown in the table by table 15-4, there is not infected by influenza infection chicken embryo when drug concentration of the invention is 32.125mg/ml Protective effect.

Brief summary

With the direct inactivation of viruses method of medicine and Antiviral Effect activation measurement, the type of medicine infected by influenza first 3, the second is observed The effect of type.As a result show, the medicine is in the average half of the type of first 3 and concentration 0.011mg/ml, in B-mode average half With concentration 0.018mg/ml, infected by influenza infection chicken embryo does not have protective effect.As a result point out, the medicine infected by influenza has neutralization Effect, without therapeutic action.

The antibacterial actions of the medicine of the present invention of experiment 9

In-vitro Inhibitory Effect of the medicine of the 9-1 present invention to common pathogen

Summary determines inhibitory action of the medicine to 8 kinds of 53 plants of common pathogens of the present invention with test tube liquid dilution method.Knot Fruit show, the medicine to staphylococcus aureus, MRSE, streptococcus, Escherichia coli, micrococcus catarrhalis, pneumobacillus and The inhibiting rate of proteus is 100%, and the inhibiting rate to Pseudomonas aeruginosa is 75%, and total inhibiting rate is 98.1%, MIC₅₀For 2.59mg/ml。

Purpose determines bacteriostasis of the medicine to common pathogen with external tube dilution method.

Material and method

Strain

This experiment pathogenic strain being clinically separated, including 9 plants of staphylococcus aureus, 10 plants of MRSE, 8 plants of streptococcus, 3 plants of micrococcus catarrhalis, 6 plants of pneumobacillus, 3 plants of Pseudomonas aeruginosa, 5 plants of proteus, 6 plants of enteropathogenic E. Coli and Staphylococcus aureus, Pseudomonas aeruginosa and each 1 plant of Escherichia coli Quality Control strain, it is totally 53 plants, raw by Chinese Academy of Medical Sciences's medicine Thing technical research institute provides.

Medicine

Experimental drug (the hereinafter referred to as medicine of the present invention) is by liquiritin, Chinese ephedra total alkali, scutelloside, oil of negundo chastetree, by 2.5: 1 : 2.5: 0.04 part by weight mixing composition.Comparison medicine Shuanghuanglian oral liquid, 1.5g crude drugs/ml, Henan bamboo grove all living creatures pharmacy stock Part Co., Ltd, lot number：03051611.The decoction of 1g crude drugs/ml concentration, 100 DEG C of sterilization standby in 30 minutes are made into distilled water With.

Culture medium

Nutrient broth dry powder, Beijing not logical sequence Deco skill centre of development import packing (U.S. ATCC), lot number：20010210. M-H fluid nutrient medium dry powder, ministry of Health of China pharmaceutical biological product calibrating institute product, lot number：000104, for bacteriostatic test.

Both the above dry powder is configured to put refrigerator after culture medium standby according to operation instructions.

5% horse serum meat soup：The sterile horse blood serum of inactivation is added in above two culture medium to 5% concentration first, B-mode chain The culture of coccus and bacteriostatic test.

Horse serum：Beijing medical officer animal doctor's centre of prevention and cure product, lot number：950520.

4. cosolvent：Dimethyl sulfoxide (DMSO), Beijing Yi Li chemical reagent Co., Ltd product, lot number：20041110.

Method

Said medicine is configured to final concentration of 32mg/ml, 16,8,4,2,1 and 0.5mg/ml 7 is diluted to successively dense The decoction of degree；Comparison medicine Shuanghuanglian oral liquid is diluted to 100,50,25,12.5,6.25,3.125,7 of 1.56mg/ml it is dense Degree, the decoction of each concentration is sequentially added into the sterile small test tube got ready, 1ml/ pipes, and each 54 row, last 1 row is to be not added with The medicine control of bacterium.The dimethyl sulfoxide (DMSO) of 2% and 4% concentration is set in addition as Matrix controls, each 54 pipes of packing.

The fresh bacterial cultures of 1: 1000 dilution is added to 0.1ml/ in the pastille test tube that above-mentioned each row has diluted Pipe, separately sets each strain control pipe of not dosing.First, second streptococcus puts 5%CO₂, culture 20 hours in 37 DEG C of insulating boxs, it is other each Bacterium puts culture in 37 DEG C of incubators and observes result after 20 hours.The drug concentration of minimum dilution factor without bacterial growth is minimum Mlc (MIC).

IC ＞ 100mg/ml are set to no bacteriostasis in this experiment, total inhibiting rate and MIC is calculated₅₀。

As a result

Experiment well-grown, the dimethyl sulphoxide control pipe pair of 2% and 4% concentration in corresponding culture medium with each bacterial strain The growth of each bacterial strain does not influence, and strain growth is good.The culture medium of pastille is without bacterial growth.Result of the test is shown in Table 16-1.

Table 16-1：Inhibitory action result of the medicine of the present invention to bacterium

It is as shown in the table, and it is 75% that medicine of the invention, which is removed to Pseudomonas aeruginosa inhibiting rate, and other strain inhibiting rates are 100%, total inhibiting rate of medicine of the invention is 98.1%, MIC₅₀For 2.59mg/ml.Table 16-2：Shuanghuanglian oral liquid is to thin The inhibitory action result of bacterium

It is as shown in the table, and Shuanghuanglian oral liquid is to staphylococcus aureus (100%), MRSE (60%), hammer Bacterium (50%), micrococcus catarrhalis (100%), pneumobacillus (16.7%), Escherichia coli (71.4%), proteus (60%) have suppression Make and use, and there is no inhibitory action to Pseudomonas aeruginosa, total inhibiting rate is 60.4%, MIC₅₀For 20.61mg/ml.As a result show, this The vitro Drug bacteriostasis of invention is better than comparison medicine Shuanghuanglian oral liquid.

Brief summary

Liquid tube dilution method is used herein, is determined the medicine of the present invention to the inhibitory action of 8 kinds of 53 plants of bacterial strains, is as a result shown Show, total inhibiting rate is 98.1%, LD₅₀Concentration is 2.59mg crude drugs/ml.The medicine In Vitro Bacteriostasis is better than comparison medicine swap buffers mouthful Take liquid.

Protective effect of the medicine of the 9-2 present invention to infection of staphylococcus aureus mouse

After summary is infected with staphylococcus aureus with 95% lethal dose to mouse peritoneal injection, the medicine pair is observed The protective effect of infected mouse.As a result show, medicine heavy dose has obvious protection to infection of staphylococcus aureus mouse Act on (P ＜ 0.05).

Purpose is observed protection of the medicine to infection animal and made after staphylococcus aureus is infected to mouse peritoneal injection With.

Material and method

Medicine by reagent is to prepare the traditional Chinese medicine extraction dry powder (medicine for calling the present invention in the following text) prepared in embodiment 1.Mouse is given Pharmaceutical quantities be 500,250,125mg/kg/ day, Chinese medicine compare GUILONG KECHUANNING JIAONANG, given birth to by Guilong Medicine Co., Ltd., Shanxi Production.Authentication code：(89) the quasi- word of medicine Z-11, product batch number are defended：030101, mouse dosage is 2g (crude drug)/kg/ days. Western medicine compares Cefradine Capsules, authentication code：Chinese medicines quasi-word H11221429, product batch number：041003, adult human dose 1.5g/ 70kg/ days, mouse dose 0.2g/kg.

The pathogenic staphylococcus (1044) that strain is separately cultured from clinical patient, by Beijing Medical University One clinical hospitals clinical laboratory provides.The fresh cultured thing for being inoculated in culture 18 hours in M-H culture mediums is being used into 5% stomach before use Membranogen dilutes.To the LD of mouse₉₅For 10^-1.4。

Culture broth culture medium dry powder, Beijing not logical sequence Deco skill centre of development product, lot number：20010210, illustratively It is standby that book puts refrigerator after preparing.

Gastric mucin capsule：Virulence for raising bacterial strain is used, Chongqing Rong Gao Biochem Pharma Inc product, lot number： 04201.The gastric mucin of 5% concentration is made into physiological saline, is sterilized within 20 minutes through 10 pounds standby.

Animal health ICR mouse 90, male and female half and half, 18~22g of body weight ties up the magnificent Experimental Animal Center of tonneau by Beijing There is provided.Licensing is numbered：SCXK11-00-0008.

Method divides experimental animal on 6 groups, i.e. bacterium infection control group (abbreviation infected group) 20, Western medicine control head at random Spore, which is drawn, determine that capsule, Chinese medicine control GUILONG KECHUANNING JIAONANG, medicine of the invention be big or middle and each 14 of small dose group, male and female half and half. Infection starts with 10ml/kg volume gastric infusion, once a day, continuous 7 days for first 7 days.In 1 hour after last dose respectively with The dosage intraperitoneal injection staphylococcus aureus bacterium solution infection of 0.6ml/ only, observes animal dead, through x day by day²Inspection compare to Difference between medicine group and infected group, and calculate the death rate.

As a result

It the results are shown in Table 16-3.

Table 16-3：Protective effect of the medicine of the present invention to infection of staphylococcus aureus animal

From table 16-3 results, animal time dead because of infection in 72 hours, death in 72 hours Animal continues to observe does not occur death in 1 week again.Infect control group 95% animal dead in 72 hours.Positive control drug cephalo is drawn Determining capsule significantly reduces the death rate (7.1%, P ＜ 0.01) of infection animal.The drug bolus group of the present invention significantly reduces sense Contaminate the death rate (64.3%, P ＜ 0.05) of animal.Chinese medicine compares the death rate and infected group of GUILONG KECHUANNING JIAONANG infection animal Compare no significant difference.

Brief summary

This experiment pathogenic staphylococcus, is injected intraperitoneally infection animal with 95% lethal dose, observes this hair Protective effect of the bright medicine to infected mouse.As a result show, the heavy dose of animal to infection of staphylococcus aureus of the medicine There is significant protective effect.

Protective effect of the medicine of the 9-3 present invention to charrin's disease mouse

After summary is infected with Pseudomonas aeruginosa with 95% lethal dose to mouse peritoneal injection, the medicine is observed to infected The protective effect of mouse.As a result show, the medicine does not have significant protective effect to charrin's disease mouse.

Purpose observes protective effect of the medicine to infection animal after golden Pseudomonas aeruginosa is infected to mouse peritoneal injection.

Material

Medicine by reagent, Chinese medicine control GUILONG KECHUANNING JIAONANG, western medicine group Cefradine Capsules, preparation, come Source, dosage, the compound method of lot number and medicine are ditto tested.

The pathogenic Pseudomonas aeruginosa (J27) that strain is separately cultured from clinical patient, is cured by Beijing Medical University first is clinical Clinical laboratory of institute provides.It will be inoculated in M-H culture mediums and cultivate the fresh cultured thing of 18 hours dilute with 5% gastric mucin before use Release.To the LD of mouse₉₅For 10^-4.0。

Culture broth culture medium dry powder, Beijing not logical sequence Deco skill centre of development product, lot number：20010210, illustratively It is standby that book puts refrigerator after preparing.

Gastric mucin capsule：Virulence for raising bacterial strain is used, Chongqing Rong Gao Biochem Pharma Inc product, lot number： 04201.The gastric mucin of 5% concentration is made into physiological saline, is sterilized within 20 minutes through 10 pounds standby.

Animal health ICR mouse 94, male and female half and half, 18~22g of body weight ties up the magnificent Experimental Animal Center of tonneau by Beijing There is provided.Licensing is numbered：SCXK11-00-0008.

Method divides experimental animal on 6 groups, i.e. bacterium infection control group (abbreviation infected group) 24, Western medicine control head at random Spore, which is drawn, determine that Capsules group, Chinese medicine control GUILONG KECHUANNING JIAONANG group, medicine of the invention be big or middle and each 14 of small dose group, male and female Half and half.Start with 10ml/kg volume gastric infusion, once a day, continuous 7 days within 7 days before bacterium infection.It is small in after last dose 1 When infected respectively with the dosage intraperitoneal injection Pseudomonas aeruginosa bacterium solutions of 0.6ml/ only, animal dead is observed day by day, through x²Inspection is compared Difference between administration group and infected group, and calculate the death rate.

As a result

As a result 16-4 is seen.

Table 16-4：Protective effect of the medicine of the present invention to charrin's disease animal

From table 16-4 results, animal time dead because of infection in 48 hours, death in 48 hours Animal continues to observe does not occur death in 1 week again.Infect control group 91.7% animal dead in 48 hours.Positive control drug cephalo Draw and determine capsule and significantly reduce the death rate (28.6%, P ＜ 0.01) of infection animal.The drug bolus of the present invention reduces infection The death rate (78.6%) of animal, but compared no significant difference (P ＞ 0.05) with infection control group.Chinese medicine compares Guilong Kechuanning Capsule The death rate of Capsules group infection animal is compared no significant difference with infected group.

Brief summary

Pathogenic Pseudomonas aeruginosa is used in this experiment, and infection animal is injected intraperitoneally with 95% lethal dose, observes the medicine of the present invention Protective effect of the thing to infected mouse.As a result show, the medicine does not have significant protective effect to the animal of charrin's disease.

Claims (11)

1. a kind of Chinese medicine composition, it is made up of following Chinese medicine material：Chinese ephedra 100-200 parts by weight, radix scutellariae 100-200 weight Part, radix glycyrrhizae 100-200 parts by weight, oil of negundo chastetree 0.2-1 parts by weight.

2. a kind of Chinese medicine composition, its active component is：Liquiritin, Chinese ephedra total alkali, scutelloside and oil of negundo chastetree, wherein liquiritin, The weight ratio of Chinese ephedra total alkali, scutelloside and oil of negundo chastetree is 2~2.5: 1: 2~2.5: 0.02~0.2.

3. a kind of Chinese medicine composition, its is consisting of the following：As the Chinese medicine composition described in the claim 1 or 2 of active ingredient, With one or more medicinal auxiliary materials.

4. the Chinese medicine composition described in claim 3, wherein the medicinal auxiliary material is in excipient, diluent or solvent It is one or more.

5. the preparation method of the Chinese medicine composition described in claim 1, this method comprises the following steps：

1) Herba Ephedrae segment, plus 10-16 times of decocting is taken to boil 2-4 times, each 1-3 hours, filtration, filtrate is concentrated to dryness, standby；

2) baikal skullcap root decoction pieces are taken, plus 6-10 times is measured water, is decocted 2-4 times, each 1-2 hours, collecting decoction is concentrated into 1/3 decocting liquid body Product, regulation pH value to 4.0 removes viscous paste impurity after standing 1 hour, take supernatant, regulation pH value to 2.0, in 4 DEG C of standings 12-24 hours, abandoning supernatant, precipitating the stirring that adds water makes it be suspended, and filters out impurity, is deposited at 80 DEG C and is dried under reduced pressure, standby；

3) extracting liquorice medicinal material adds 10-16 times to measure decocting and boiled 2-4 times, each 2-3 hours, collecting decoction, and filtration, filtrate is concentrated into 1/ 2 volumes, adjust pH value to 2.0, standing is stopped when being separated out without yellow mercury oxide, and abandoning supernatant is deposited at 60 DEG C and is dried under reduced pressure, It is standby；

4) according to oil of negundo chastetree: beta-schardinger dextrin: the weight ratio that water is 1: 6~10: 50~100, the beta-schardinger dextrin of respective amount is taken, is added In water, heating is allowed to be completely dissolved, and puts and is cooled to less than 50 DEG C at room temperature, side stirring, side adds Herba Viticis Cannabifoliae volatile oil, and in constant temperature It is lower continue stir 1-3 hour, put 4 DEG C stand 8-12 hours, suction filtration sediment to do；

5) by step 1)~step 4) in obtain product mixing produce.

6. purposes of the Chinese medicine composition described in claim any one of 1-4 in medicine is prepared, the medicine has anti-inflammatory, solution Heat, spasmolysis, relieving asthma, antibechic, eliminating the phlegm, enhancing immune, antibacterium or at least one of antiviral effect.

7. purposes of the Chinese medicine composition described in claim any one of 1-4 in medicine is prepared, the medicine be used to treat and/ Or prevent at least one of following inflammation in respiratory system：The inflammation as caused by bio-pathogen, and the abiotic pathogen factor Caused inflammation, wherein the bio-pathogen is selected from bacterium, fungi, virus, mycoplasma, Chlamydia, Richettsia or Cattell Lung sac worm.

8. the purposes described in claim 7, it is characterised in that the bio-pathogen is bacterium, the bacterium is selected from following bacterium At least one of：Staphylococcus aureus, MRSE, streptococcus, Escherichia coli, micrococcus catarrhalis, klebsiella spp, Legionella, Pseudomonas aeruginosa, pneumococcus and proteus.

9. the purposes described in claim 7, it is characterised in that the bio-pathogen is virus, the virus is in following It is at least one：Influenza virus, Coxsackie virus, coronavirus, measles virus, parainfluenza virus, Respiratory Syncytial Virus(RSV), rhinopathy Poison, adenovirus, herpesviral, cytomegalovirus.

10. purposes of the Chinese medicine composition described in claim any one of 1-4 in medicine is prepared, the medicine is used to treat And/or in the following clinical symptom of inflammation caused by prevention inflammation as caused by bio-pathogen and the abiotic pathogen factor It is at least one：Cough, heating, expiratory dyspnea, spitting of blood, expectoration, out of breath, wheezing, pant, pectoralgia.

11. purposes of the Chinese medicine composition described in claim any one of 1-4 in medicine is prepared, the medicine is used to treat And/or in the following clinical sign of inflammation caused by prevention inflammation as caused by bio-pathogen and the abiotic pathogen factor It is at least one：Hyperpyrexia, sweating and do not understand, cough out of breath, nose incites rough, cough up phlegm yellow thick or cough up rusty expectoration, pectoralgia is thirsty Agitation, dark urine is hard and dry, red tongue with yellowish fur, slippery and rapid pulse or big vast number.