CN1460492A

CN1460492A - Chinese medicine preparation for curing acute and chronic rhinitis and its production method

Info

Publication number: CN1460492A
Application number: CN03128114A
Authority: CN
Inventors: 孙佶; 戴玉英
Original assignee: GUANGXI YIKANG PHARMACEUTICAL INDUSTRY Co Ltd
Current assignee: Guangxi Lmz Ecan Pharmaceutical Co ltd
Priority date: 2003-06-03
Filing date: 2003-06-03
Publication date: 2003-12-10
Anticipated expiration: 2023-06-03
Also published as: CN1246008C

Abstract

The present invention relates to a Chinese medicine preparation for curing acute and chronic rhinitis. It is made up by using 7 Chinese medicinal materials of patchouli, schizonepeta, centipeda, xanthium fruit, scutellaria root, dahurian agelica root and chrysanthemum flower, and its therapeutic effect is obvious, and its total effective rate is 90%. Said invention also provides its preparation method, and can be made into various dosage forms of tablet, granules, capsule, oral liquor, pill and nose drops.

Description

The Chinese medicine preparation and the production method thereof of treatment acute and chronic rhinitis

Technical field

The present invention relates to a kind of medicine for the treatment of acute and chronic rhinitis, is the Chinese medicine preparation of raw material for treating acute and chronic rhinitis with Chinese medicine Fructus Xanthii, Herba Centipedae etc. particularly.

Background technology

The acute and chronic rhinitis of describing on the traditional Chinese medical science comprises that wind heat is accumulate poison and the various acute and chronic rhinitis, sinusitis, the allergic rhinitis that cause, many because of be subjected to stimulation such as dust, smog, gas or because of overfatigue, suffer from cold wet after, skin and respiratory mucosa ischemia, local resistance weakens, and virus, antibacterial are taken advantage of the occasion to invade and fall ill.Often made people's nasal obstruction, rhinocnesmus, sneeze, watery nasal discharge after getting rhinitis, the nasal mucosa edema, breathing has some setbacks, and nasal cavity is felt bad, and chronic simple rhinitis that has and rhinitis also can cause headache, insomnia, the thought that works together is not easy to concentrate, and has brought very big worry to the people.

Chinese traditional treatment to allergic rhinitis at present has several different methods, and each is variant for the distinct methods therapeutic effect.According to the theory that dialectical opinion is controlled, allergic rhinitis is in the majority with insufficiency of lung-QI person, and person with Spleen Deficiency takes second place.Give warming the lung for being in harmony substantially then to deficiency of the lung person, person with Spleen Deficiency gives spleen invigorating.Compendium of Materia Medica record: Herba Centipedae can stuffy nose relieving gas, and the sharp seven apertures are told wind-phlegm, and plug breath is from falling.With the Herba Centipedae treatment of allergic rhinitis report is arranged also in recent years, the allergic rhinitis that also has the scholar report to adopt the YUPINGFENG SAN treatment to fail to respond to any medical treatment through hormone and drug desensitization.

By retrieval, we have found to disclose on the Chinese science and technology periodical Chinese medicine preparation of some treatment acute and chronic rhinitis, as " Chinese herbal medicine " 2001,32 (8) have published the article of Lee of Shenzhen City Baoan District People's Hospital Huimin, " preparation and the clinical observation of compound recipe Herba Centipedae nasal drop " reported with Herba Centipedae, Fructus Xanthii, Flos Magnoliae is a principal agent, be equipped with Aloe, Mentholum, Borneolum Syntheticum, make compound nose drop, the rheumatism of can loosing, clearing the nasal passage, end the nasal sinusitis watery nasal discharge, removing heat from the liver, dampness is ended miasma, and stronger anti-mattress antiinflammatory and anti-allergic effects are arranged, and is used for the treatment of various acute and chronic rhinitis, sinusitis, diseases such as allergic rhinitis; " Jinzhou Medical College's journal " 2001,22 (3), the Song Qiong of Suizhong County hospital department of eye has delivered the article of " Herba Centipedae, Fructus Xanthii topical application treatment of allergic rhinitis ", introduce and use Herba Centipedae and Fructus Xanthii to make intermixture in 2: 1 ratios, after the high-temperature sterilization, be applied to the nasal membrane surface.Once a day, 10 times is a course of treatment, oral YUPINGFENG SAN simultaneously, the end is person or 1 week of the person of consolidation gap use a course of treatment more, Herba Centipedae, Fructus Xanthii local with after, of short duration sneeze of a few patients and stream clear water tears are arranged, disappear after the medication for several times; " Shandong journal of Chinese medicine " 1995,14 (12) .-554-554 have also published the article of Yan Rongjun, third place victory, and " Herba Centipedae Fructus Xanthii drop nose treatment rhinitis 54 examples ", report adopts the Herba Centipedae Fructus Xanthii to make nasal drop, the treatment chronic rhinitis.

Chinese patent also discloses following about being the Chinese medicine preparation of raw material for treating acute and chronic rhinitis with Chinese medicine Fructus Xanthii, Herba Centipedae etc.:

1,＜and application number〉98122221＜denomination of invention〉the Chinese medicine nasal spray and the manufacturing process＜digest thereof of treatment rhinitis〉a kind of Yanminling nasal spray and manufacturing process thereof, it is characterized in that: making 30 kilograms of nasal sprays needs Aloe 1.95-2.05 kilogram, Flos Magnoliae 7-8 kilogram, Fructus Xanthii 7-8 kilogram, Herba Centipedae (doing) 14.5-15.5 kilogram, Herba Menthae 4.5-5.5 kilogram, Moschus 9-11 to restrain.Manufacturing process of the present invention is: get Herba Centipedae, Flos Magnoliae, Herba Menthae are used steam distillation, collect distillate, again its medicinal residues and Fructus Xanthii are decocted with water twice, each two hours, collecting decoction, filter, filtrate is concentrated in right amount, merge with 75% ethanol dissolving Aloe and concentrated filtrate, add 65% alcohol precipitation 24 hours, and got supernatant, recovered alcohol, the gained medicinal liquid adds Moschus, filter, gained filtrate adds above-mentioned distillate, adds an amount of distilled water promptly.

2,＜and application number〉98110168＜denomination of invention〉preparation method＜digest of rhinitis oral liquid〉the present invention relates to a kind of preparation method acute and chronic and the allergic rhinitis oral liquid for the treatment of, heavy hundred groups of this each composition of oral liquid Chinese medicine is Fructus Xanthii 20-24%, Fructus Mume 6-8%, Flos Magnoliae 4-6%, two precious flower 1-2%, Herba Pogostemonis 6-8%, Radix Scutellariae 4-6%, Radix Angelicae Sinensis 4-6%, Fructus Schisandrae Chinensis 2-3%, Radix Bupleuri 2-3%, Flos Chrysanthemi 1-2%, Radix Rubiae 1-2%, Radix Saposhnikoviae 11-1 3%, Radix Glycyrrhizae 12-13%, the quick 0.01-0.03% of Mel 14-16%, Piao Er, Herba Centipedae 4-6%.Rhinitis oral liquid of the present invention have medication rationally, be easy to processing, taking convenience, have no side effect, effective percentage is more than 92%.

3,＜and application number〉93100941＜denomination of invention〉medicine " Xincangbiyuan powder " for treating rhinitis＜digest〉the invention discloses a kind of Chinese medicine for the treatment of rhinitis, particularly a kind of medicine " Xincangbiyuan powder " for treating rhinitis, this medicine by Fructus Xanthii, Flos Magnoliae, Herba Centipedae, the Radix Angelicae Dahuricae, Herba Asari, dried Alumen, catechu, Indigo Naturalis, Pedicellus Melo, Radix Kansui, Asteriscus Pseudosciaenae ten simply Chinese medicine constitute, their weight ratio is that unit is 35: 30: 20 with the gram: 20: 20: 20: 20: 20: 17: 17: 20.Its technology be through choosing medicine (1), dry (2), roll (3), sieve (4), make powder medicated powder (5), be mixed in proportion (6), packing (7) forms.The present invention be owing to can directly spray and be distributed in nasal cavity, utilizes can directly the absorb the drug characteristics of performance drug effect of nasal mucosa, has that medication is few, curative effect fast, the curative effect advantages of higher.

4,＜and application number〉93103946＜denomination of invention〉bidouyan mixture, bidouyan koufuye＜digest〉the present invention relates to a kind of bidouyan mixture, bidouyan koufuye, the oral medicine for the treatment sinusitis belongs to drug class.This medicine composition is: Fructus Xanthii, Flos Magnoliae, Herba Asari, Rhizoma Chuanxiong, Herba Ephedrae, Fructus Mume, Radix Glycyrrhizae, Herba Centipedae, the roach clothing, Cortex Moutans etc. decoct the good blending water of above-mentioned medical material proportioning three times, and the decocting liquid of gained is concentrated into the thickness paste, with the ethanol dilution, filter, regulate pH value, add an amount of distilled water, cold preservation is filtered, and adds tween again, nipalgin, an amount of essence, sugared seasoning is filtered and is distributed into 10 milliliters one, and per 10 or 20 is box packing.This oral liquid treatment acute sinusitis, chronic sinusitis.

5,＜and application number〉94101473＜denomination of invention〉medicinal liquid and preparation method thereof＜digest of treatment rhinitis〉be used for the treatment of the medicinal liquid and the method for making thereof of rhinitis, this medicinal liquid contains: Chinese medicine ingredients such as Fructus Xanthii, Moschus moschiferous are equipped with, Radix Ginseng Rubra, Spina Gleditsiae, Fructus Mume, the Radix Astragali, Flos Magnoliae, Radix Salviae Miltiorrhizae, Herba Ephedrae, Herba Menthae, Herba Centipedae, Mel.When effective component extracting, Flos Magnoliae, Herba Menthae are adopted the way of distillation; Radix Ginseng Rubra, Spina Gleditsiae, Herba Ephedrae, Herba Centipedae, Radix Salviae Miltiorrhizae, the Radix Astragali, Fructus Xanthii, Fructus Mume adopt solvent extraction method; Moschus, Mel then directly are dissolved in the medicinal liquid.This medicinal liquid reaches 100% to various acute and total effective rates chronic rhinitis, and cure rate is more than 95%

The Chinese medicinal formulae of above-mentioned open source literature report or preparation major part can heat clearing and inflammation relieving, expelling pathogenic wind and restoring the functions of orifices in face, be used to control sneeze, nasal obstruction, the headache that chronic rhinitis causes, allergic rhinitis, symptoms such as chronic sinusitis are not very remarkable but exist curative effect yet, shortcomings such as produce effects is slow, and the course of treatment is long.

Technology contents

The mechanism of inventor's Chinese traditional treatment acute and chronic rhinitis is set out, through some traditional Chinese herbal medicine are analyzed and clinical trial, and excavated part ancient prescription secret recipe, determined that the various acute and chronic rhinitis of a kind of treatment are effective, esy to use, safe and reliable, Chinese medicine preparation has no side effect.

Technical scheme of the present invention is as follows: the Chinese medicine preparation that the present invention treats acute and chronic rhinitis comprises Fructus Xanthii, Herba Centipedae, and the composition and the weight percentage of its raw material are as follows:

Fructus Xanthii 10-20 Radix Scutellariae 10-20

Herba Pogostemonis 10-20 Herba Centipedae 10-18

Radix Angelicae Dahuricae 8-15 Herba Schizonepetae 8-15

Flos Chrysanthemi 2-8 Flos Chrysanthemi Indici 2-8

Fel Sus domestica unguentum 0.5-4 chlorphenamine maleate 0.01-0.04

Sodium Houttuyfonate 0.1-0.5 Oleum menthae 0.01-0.06

The production method that the present invention treats the Chinese medicine preparation of acute and chronic rhinitis is:

With Herba Pogostemonis, Herba Schizonepetae, the Herba Centipedae chopping is extracted volatile oil with steam distillation, and volatile oil is standby, its decocting liquid filters, and medicinal residues decoct with water 1 hour again, filters, merging filtrate, concentrated standby, Fructus Xanthii, Radix Scutellariae, the Radix Angelicae Dahuricae, Flos Chrysanthemi and Flos Chrysanthemi Indici decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter, filtrate and above-mentioned reserve liquid merge, being concentrated into relative density is 1.20 (80 degree), put coldly, add ethanol and make and contain alcohol amount and reach 60%, left standstill 24-48 hour, get supernatant, reclaim ethanol and be condensed into thick paste, drying adds Fel Sus domestica unguentum, chlorphenamine maleate, Sodium Houttuyfonate, above-mentioned volatile oil adds adjuvant again, make tablet or granule, capsule, oral liquid, pill, nasal drop obtains product.

Below be the production method of various preparations of the present invention:

1, the production method of tablet: with above-mentioned concentrated thick paste, volatile oil, Fel Sus domestica unguentum, chlorphenamine maleate, the Sodium Houttuyfonate for preparing, mix, make granule with an amount of filler, disintegrating agent, tabletting, sugar coating obtains product.

The described filler of above tablet is starch, dextrin, carboxymethyl starch, calcium hydrogen phosphate and other pharmaceutic adjuvants; Described disintegrating agent is sodium carboxymethyl cellulose, hydroxypropyl cellulose and pharmaceutic adjuvant with water swelling; Described lubricant is the pharmaceutic adjuvant of Polyethylene Glycol, magnesium stearate, Pulvis Talci and tool lubrication.Wherein the weight content of filler, disintegrating agent is respectively: 45～75%, 0.5～10%, and the lubricant weight content is: 0.5～10%.

2, the production method of capsule: concentrated thick paste, volatile oil, Fel Sus domestica unguentum, chlorphenamine maleate, Sodium Houttuyfonate that above-mentioned production is obtained add filler, disintegrating agent and fluidizer; and make it dry; or make granule or make micropill, in incapsulating then, obtain product.

More than the described filler of preparation capsule is starch, dextrin, carboxymethyl starch, calcium hydrogen phosphate and other pharmaceutic adjuvants; Described disintegrating agent is sodium carboxymethyl cellulose, hydroxypropyl cellulose and pharmaceutic adjuvant with water swelling; Described fluidizer is that magnesium stearate, differential silica gel and other have the pharmaceutic adjuvant of fluidizer effect.Filler, disintegrating agent, fluidizer weight content are: 30～70%, 0.5～20%, 0.5～5%.

3, the production method of pill: the concentrated thick paste that above-mentioned production is obtained, volatile oil, Fel Sus domestica unguentum, chlorphenamine maleate, Sodium Houttuyfonate add excipient 10～100% white sugar or medicinal residues xeraphium, starch after Mel and the extraction are made water-honeyed pill, big honeyed pills, concentrated pill product by weight.

4, the production method of granule: the concentrated thick paste, volatile oil, Fel Sus domestica unguentum, chlorphenamine maleate, the Sodium Houttuyfonate that obtain in above-mentioned production add filler, make granule, make it dry, obtain product.

The filler that adds is sucrose, lactose, dextrin, starch.

5, the preparation method of oral liquid is: will concentrate thick paste, volatile oil, Fel Sus domestica unguentum, chlorphenamine maleate, Sodium Houttuyfonate adding sucrose, Mel or sweeting agent, antiseptic, and obtain product.

6, the preparation method of nasal drop is: will concentrate thick paste, volatile oil, Fel Sus domestica unguentum, chlorphenamine maleate, Sodium Houttuyfonate and add 10 times of distilled water dilutings, and cross the elimination insoluble matter, bottling is sealed, and obtains product.

Outstanding substantive distinguishing features of the present invention and obvious improvement are:

Adopt traditional Chinese herbal medicine Herba Pogostemonis, Herba Schizonepetae, Herba Centipedae, Fructus Xanthii, Radix Scutellariae, the Radix Angelicae Dahuricae, Flos Chrysanthemi and Flos Chrysanthemi Indici, and add Fel Sus domestica unguentum, chlorphenamine maleate, Sodium Houttuyfonate, the product heat-clearing and toxic substances removing of presenting a memorial to the emperor altogether, the effect of reducing swelling and alleviating pain.Can loose rheumatism, clearing the nasal passage, end the nasal sinusitis watery nasal discharge, removing heat from the liver, dampness is ended miasma, and stronger anti-mattress antiinflammatory and anti-allergic effects are arranged, and is used for the treatment of diseases such as various acute and chronic rhinitis, sinusitis, allergic rhinitis, and significant curative effect is arranged.Following explanation earlier side of the present invention separate:

One, the pharmacological research of Fructus Xanthii

[pharmacology] 1. anti-microbial effect Fructus Xanthii decoct external to the effective strong antibacterial action of staphylococcus aureus and anthrax bacillus, streptococcus pneumoniae, group B streptococcus and diphtheria corynebacterium are also had antibacterial action.Fructus Xanthii acetone or alcohol extract is to trichophyton purpureatum, and its decoct has antifungic action to trichophyton.The Fructus Xanthii decoct is 25%～50% at external direct suppression ratio to hepatitis B virus DNA polysaccharide (DNAP), shows that it has the hepatitis virus resisting effect ^[6]

2. antiinflammatory and analgesic activity Fructus Xanthii methanolic extract 250mg/kg lumbar injection are 30%～60% to the bullate suppression ratio of rat carrageenan foot; The 1000mg/kg subcutaneous injection, the suppression ratio that the mice acetic acid twisting is reacted is 10%～30%, shows that this product has certain antiinflammatory and analgesic activity.In addition, the carboxyl potassium atractylate swells to the rat carrageenan foot also inhibitory action.

3. Immune Effects Fructus Xanthii decoct 0.5g (crude drug)/is only irritated stomach, every day 1 time, continuous 10 days, show that through hemolytic plaque test (PEC), macrophage phagocytic function test and leukocyte migration inhibition test Fructus Xanthii all has obvious inhibitory action to cellular immunization and the humoral immune function of the purebred mice of C57/BL.Herba Xanthii to T ^HAnd T ^SThe cell number average has the minimizing effect, and makes T ^H/ T ^SRatio reduces.Fructus Xanthii all has remarkable reduction effect to the beta-endorphin in hypothalamus and the blood plasma.In addition, Fructus Xanthii still can reduce the active and IL-2 content receptor of interleukin II (IL-2).In sum, the immunosuppressive action of Fructus Xanthii is relevant with its influence to t lymphocyte subset group distribution and beta-endorphin generation.

4. to respiratory system effect Fructus Xanthii tincture low dose respiratory movement is strengthened, heavy dose then makes its inhibition.100% Fructus Xanthii decoct 03ml irritates stomach, and mice is had antitussive effect; 15mg/kg does not still have phlegm-dispelling functions to rabbit.Fructus Xanthii alcohol extract 4g/ml and water extract 1.3g/ml all do not have the antihistamine effect to guinea-pig isolated trachea.

5. the toxic component water soluble of toxicity Fructus Xanthii, the LD of its water logging agent mouse peritoneal injection ₅₀Be 0.93g/kg.The poisoning symptom of rat, mice, Cavia porcellus and the administration of rabbit different approaches is basic identical, mainly contains movable the minimizing, and irritant reaction is blunt to external world, irregular respiration, and dead preceding breathing is the devil and faints from fear with paroxysmal.Pathological tissue regular script liver has degeneration or necrosis; Kidney curved tube epithelium cloudy swelling has albumen, cast in the tube chamber; Lung, cephalemia edema, the slight cloudy swelling of heart, wherein liver injury is the most serious, with carbon tetrachloride (CCI ₄) infringement is similar, faints from fear due to the Secondary cases cerebral edema, and is also relevant with extreme hypoglycemia.25% Fructus Xanthii Emulsion lumbar injection is to the absolute lethal dose LD of rabbit ₁₀₀Be 10ml/kg; The LD of mouse peritoneal injection ₅₀Be 7.5ml/kg.AA ₂The LD of mice and rats by intraperitoneal injection _{50 respectively}Be 10mg/kg and 4.6mg/kg.The LD of carboxyl atractylic acid potassium mouse peritoneal injection ₅₀Be 10.7mg/kg.The LD of the injection of carboxyl potassium atractylate mouse peritoneal, subcutaneous injection and filling stomach ₅₀Be respectively 2.9mg/kg, 5.3mg/kg and 350mg/kg.

Two, the pharmacological research of Radix Scutellariae

[pharmacology] 1. anti-microbial effect Radix Scutellariae decoct has stronger bacteriostasis external to staphylococcus, Hemolytic streptococcus, diphtheria corynebacterium, Bacillus typhi and vibrio cholera, and streptococcus pneumoniae, dysentery bacterium, escherichia coli, Salmonella paratyphi, Bacillus proteus and bacillus pyocyaneus are also had inhibitory action; To will congratulate, this is close, Fu Shi and bacterium sonnei all have and suppress or killing action; Anthrax bacillus also there is inhibitory action.Decoct and alcoholic extract have more weak inhibitory action to meningococcus, and the larynx spraying can make the epidemic encephalitis bacillicarrier turn out cloudy.Radix Scutellariae decoct and influenza virus PR ₈Strain mixes the back and gives the mice collunarium, and more simple malicious collunarium person is light for the pulmonary lesion of infecting mouse, and the time-to-live is also longer, uses earlier viral collunarium as mice, and reuse Radix Scutellariae decoct collunarium is also drunk the Radix Scutellariae decoct effect same is also arranged.

2. antiinflammatory and anti-allergy action mouse gavaging Radix Scutellariae methanolic extract 500mg/kg, baicalin or baicalin 50mg/kg or 100mg/kg, wogonin 100mg/kg, the vascular permeability increase that lumbar injection acetic acid is brought out has the dose-dependent inhibition effect; Rats gavaged Radix Scutellariae methanolic extract 200mg/kg, baicalin, baicalin or wogonin 100mg/lg, except that wogonin was invalid, the foot that on Carrageenan causes is swollen only to have obvious inhibitory action in 1 hour in experiment; The foot that compound 48/80 is caused is swollen to gavage baicalin, baicalin or wogonin 100mg/kg also obvious inhibitory action, but curative effect is not as good as indomethacin (indometacin); Swollen to rat granuloma, gavage Radix Scutellariae methanolic extract 500mg/lg, or baicalin, baicalin, wogonin 100mg/kg all there are not obvious influence; To rat assist agent arthritis, gavage Radix Scutellariae methanolic extract 100mg/kg or 200mg/kg, behind injection adjuvant 1～9 day invalid, but behind the injection adjuvant the 11st～27 day, swollen joint is also showed inhibitory action, and bone degeneration and destruction that adjuvant is caused also have inhibition, but curative effect is not as good as Phenylbutazone.

3. the toxicity mouse peritoneal is injected baicalin LD ₅₀Be 3081mg/kg, animal lies prostrate motionlessly after the medication, closes one's eyes, and righting reflex does not disappear, and breathes slowly, and because of suffocating, twitch death, heart is still jumped ^[32]The quiet notes Radix Scutellariae of rabbit preserved material 2g/kg, calm after 15 minutes, sleep after 30 minutes, dead after 8～12 hours.Dog gavages the Radix Scutellariae preserved material vomiting, gavages 5g/ (kg.d), in continuous 8 weeks, can make loose and watery stool soft.

Three, the pharmacological research of Herba Pogostemonis

[pharmacology] 1. the bacteriostasis Pogostone is external that funguses such as Candida albicans, Cryptococcus histolyticus, rhizopus niger are had the obvious suppression effect, and antibacterials such as Jia Xingrongxuexinglianqiujun are also had certain inhibitory action.The bright juice of Herba Pogostemonis leaf also has certain inhibitory action to the growth of staphylococcus aureus, Staphylococcus albus and bacillus subtilis.Its bright juice drips the acute experiment Cavia porcellus otitis externa that ear (4 droplets/time, every day 3 times) can be treated caused by Staphylococcus aureus.Pogostone can suppress fungi growth such as penicillium, can be used for the anticorrosion of oral liquid.

Four, the pharmacological research of Herba Centipedae

[pharmacology] 1. anti-allergic effects Herba Centipedae hot water extract shows remarkable anti-allergic effects in animal skin passive anaphylaxis (PCA), also can suppress compound 48/80 or the inductive rat abdominal cavity mastocyte of con A histamine release strongly.Arnicolide wherein, the chrysanthemum spirit of 6-O-senecioyl dihydro and Caulis et Folium piperis ethyl sodio acetoacetic ester suppress the IC of histamine release ₅₀Be respectively 3.0 * 10 ^-5Mol/L, 1.8 * 10 ^-5Mol/L and 2.3 * 10 ^-4Mol/L.In the PCA test, oral 50mg/kg, preceding two kinds of chemical compounds ooze out suppression ratio to pigment and are respectively 61.76%, 37.4%.The flavone compound that contains is to the IC of group by release ₅₀Be 1.0mol/L～0.5 * 10 ^-5The oral 50mg/kg of mol/L reaches 39%～67% to PCA test suppression ratio.

2, other effect volatile oil and ethanol extracts some cough-relieving partly arranged, eliminate the phlegm, antiasthmatic effect, the heavy part cough suppressing effect of drilling is not obvious, no phlegm-dispelling functions.Decoct 25% ~ 50% has some inhibitory action to tubercule bacillus in Rhizoma Solani tuber osi egg solid medium.The 100% decoct flat board method that burrows has inhibitory action to staphylococcus aureus.

Five, the pharmacological research of the Radix Angelicae Dahuricae

[pharmacology] 1, analgesic, analgesia and the antiinflammatory action Radix Angelicae Dahuricae or Radix angelicae dahuricae decoct 15g (crude drug)/kg irritate stomach, and the rabbit that generates heat due to the subcutaneous injection peptone of back is had the trivial solution heat effect, and its effect is better than the aspirin of 0.1g/kg.Radix Angelicae Dahuricae decoct water extract 8g (the crude drug)/kg of ether extract irritate stomach, the suppression ratio of mice acetic acid twisting reaction is respectively 69.9%, 52.86% and 40.53%; The test of mice hot plate method also makes the threshold of pain obviously improve, and Radix Angelicae Dahuricae decoct 4g (crude drug)/kg irritates stomach, and xylol induced mice ear inflammation also has obvious inhibitory action.Other has the report Radix Angelicae Dahuricae that folder tail and boiling hot tail are caused pain unrestraint effect.

2, the anti-microbial effect Radix Angelicae Dahuricae has in various degree inhibitory action external to escherichia coli, Song Shi and bacterium flexneri, Bacillus proteus, typhoid fever and Salmonella paratyphi, bacillus pyocyaneus, vibrio cholera, some gram-positive bacteria and Bacillus tuberculosis etc.In vitro to acrothesium floccosum, Gypsum Fibrosum sample microspore tinea bacterium, ulotrichy microspore's tinea bacterium, water logging agent in 1: 3 is to Austria Du big belly microspore tinea bacterium, and 1: 10 decoct has in various degree inhibitory action to Trichophyton concentricunm, trichophyton and acrothesium floccosum etc.In addition, the Radix Angelicae Dahuricae makes the Embryo Gallus domesticus of inoculation inoculation city eqpidemic disease poison prolong life 6 hours.

3, the LD of the little root of Dahurian angelica mouse stomach of toxicity ₅₀Be 42 ~ 45g/kg; The LD of angelica anomala decoct and ether extract mouse stomach ₅₀Be 190.6 ~ 212.7 times of human dose.The LD of angelica anomala decoct and ether extract mouse stomach ₅₀Be respectively 43g (crude drug)/kg and 54g (crude drug)/kg.

Six, the pharmacological research of Herba Schizonepetae

[pharmacology] be antiinflammatory action Herba Schizonepetae water decoction 20g (crude drug)/kg lumbar injection 1., the mouse ear face is coated with inflammatory reaction has obvious inhibitory action due to the Oleum Tiglii mixing proinflammatory agent ^[2]Herba Schizonepetae volatile oil main component pulegone 100mg/kg irritates stomach, and the suppression ratio that the abdominal cavity is oozed out is 39.8%, and its antiinflammatory action intensity and aminophenazone are about equally.3-capryl alcohol and nopinene also have certain antiinflammatory action.Contained benzofuranyl acrylic acid derivative also has the obvious anti-inflammatory and anti effect in the Herba Schizonepetae alabastrum, at external IC to 3alpha-Hydroxysteroid dehydrogenase ₅₀Be 2.4 μ g/ml, and the caffeinic IC of known antiinflammatory ⁵⁰This 139.8 μ g/ml.

2. eliminate the phlegm and antiasthmatic effect Herba Schizonepetae oil 0.5ml/lg filling stomach or 0.25ml/kg lumbar injection, the phenol red method test of mice shows that phlegm-dispelling functions is arranged.The Herba Schizonepetae oil guinea pig tracheal smooth muscle that can directly relax, its minimal effective concentration is 0.1mg/kl; The tracheal smooth muscle that Herba Schizonepetae oil still can resist due to the salty or histamine of acetyl gallbladder shrinks, spraying or gastric infusion obviously prolongs acetylcholine and the histamine mixed liquor was breathed heavily incubation period drawing of Cavia porcellus, and reduce the number of animals of twitching takes place.

3. anti-microbial effect Herba Schizonepetae water decoction has stronger antibacterial action to staphylococcus aureus, staphylococcus epidermidis, Bacillus proteus, bronchus deteriorated blood are rich for bacillus and diphtheria corynebacterium external, and anthrax bacillus, group B streptococcus, pneumobacillus, dysentery bacterium and bacillus pyocyaneus etc. are also had certain antibacterial action.Its 100F% immersion also has in various degree inhibitory action to dysentery bacterium, Bacillus proteus, pneumobacillus, Bacillus typhi, escherichia coli and staphylococcus aureus etc. in vitro.In the uncommon sodium first kind fluid medium of gram, the Herba Schizonepetae water decoction has the anti-mycobacterium tuberculosis effect, and its effective dilution factor that suppresses tubercule bacillus is 1: 100.The every Embryo Gallus domesticus 0.1ml of 50% Herba Schizonepetae water decoction injects in the allantoic cavity, to influenza A virus PR ₈Strain unrestraint effect, but obvious inhibition influenza virus A is arranged ₃Effect.

4. 1. acute toxicity test of toxicity: the LD of Herba Schizonepetae water decoction mouse peritoneal injection ₅₀Be 39.8g (crude drug)/kg.The LD of Herba Schizonepetae oil mouse stomach ₅₀Be 1.1ml/kg.The LD of Herba Schizonepetae charcoal liposoluble extract (StE) mouse stomach ₅₀Be the quite former charcoal drug 41.90g/kg of 2.652g/kg, be 244～367 times of clinical dosage.The LD of StE mouse peritoneal injection ₅₀Be 1.945g/kg.2. subacute toxicity test: irritate stomach Herba Schizonepetae oil (0.15ml/kg) by 25 times of dosage to the adult of every 1kg body weight to rabbit every day, and continuous 20 days, the function of main organs and formation did not all have the overt toxicity reaction.

Seven, the pharmacological research of Flos Chrysanthemi

[pharmacology] 1. the outer test of antibacterial action Flos Chrysanthemi decocting liquid has bacteriostasis to staphylococcus aureus, beta hemolytic streptococcus.The Flos Chrysanthemi infusion to trichophyton, Trichophyton concentricunm, permitted blue achorion, Du's big belly microspore tinea bacterium difficult to understand, rust microspore's tinea bacterium, Pilus Caprae seu Ovis sample microspore tinea bacterium, epidermophyton inguinale, epidermophyton rubrum, star-shaped nocardia bacteriostasis arranged ^[2]

Eight, the pharmacological research of Flos Chrysanthemi Indici

[pharmacology] 1, resisting pathogenic microbes effect Flos Chrysanthemi Indici water preparation are respectively 0.19g/ml, 0.75g/ml, 1.5g/ml to the external minimum inhibitory concentration of staphylococcus aureus, escherichia coli, dysentery bacterium, bacillus pyocyaneus, illustrate the staphylococcus aureus inhibitory action stronger.To the mice of artificial challenge staphylococcus aureus, the abdominal cavity injects Flos Chrysanthemi Indici water preparation 0.2ml protective effect when (containing crude drug 0.3g).The Flos Chrysanthemi Indici water decoction is to strong malicious bacillus tuberculosis typus humanus (H ₅₇Rv), the minimum inhibitory concentration of Kansas mycomycete is respectively 2.5mg/ml, 10mg/ml, and Mycobacterium intracellulare is not demonstrated antibacterial action.

2, the LD50 of the quiet notes Flos Chrysanthemi indici injection of toxicity mice is 10.47g/kg; Give mice lumbar injection every day 0.2g/kg, continuous 1 month, compare with matched group, the body weight gain indifference is put to death dissection perusal no abnormality seen and is stayed ^[1]Chrysanthemol abstract HC-I 300mg/kg irritates stomach to dog, in continuous 3 weeks, except that vomiting sometimes, appetite, body weight, electrocardiogram, the blood sulfobromophthalein sodium rate of retaining is not had obvious change.

Nine, the pharmacological research of Fel Sus domestica unguentum

1, the effect Fel Sus domestica 37.5ml/kg to respiratory system irritates stomach to mist ammonia induced mice cough effect.Pulvis Fellis Suis 0.5～1.0kg irritates stomach or sodium cholate 20mg/kg vein is penetrated, to electricity irritation anesthetized cat superior laryngeal nerve is cough caused inhibitory action arranged, Fel Sus domestica 50ml/kg irritates stomach, and the phenol red method of mice experimental results show that obvious phlegm-dispelling functions, and the what is said or talked about of dispelling of Hyodeoxycholic Acid sodium is used stronger.

2, antibacterial action Fel Sus domestica, Pulvis Fellis Suis, swine bile acid and its esters have antibacterial action to various bacteria.As, Fel Sus domestica is 1: 1～1: 16 at external Mlc to bordetella pertussis.In addition, Fel Sus domestica (powder) or cholate have inhibitory action in various degree to first type and group B streptococcus, streptococcus pneumoniae, staphylococcus aureus, micrococcus catarrhalis, four folded coccus, hemophilus influenza and tubercule bacillus etc.Hyodeoxycholic Acid also has antibacterial action to pertussis, diphtheria corynebacterium and golden yellow Fructus Vitis viniferae fungus ball.The antibacterial action mechanism of bile acid (salt) may be to disturb the growth of antibacterial by reducing surface tension effects, or makes the somatic cells film destroy and make cellular lysate.

Ten, the effect of chlorphenamine maleate: chlorphenamine is a histamine H ₁Beta blocker, antihistamine effect is stronger, and central inhibitory action and cholinolytic effect a little less than.Be mainly used in the anaphylactic disease of skins such as urticaria, pollinosis, allergic rhinitis, conjunctivitis and contact dermatitis, mucosa, also can be used for vasodilation, food anaphylaxis.Some bronchial asthma also there is mitigation.

11, the effect of Sodium Houttuyfonate: streptococcus pneumoniae, hemophilus influenza, drug-resistant staphylococcus aureus, Hemolytic streptococcus, Candida albicans etc. are had inhibitory action, be used for upper respiratory tract infection, chronic bronchitis and infantile pneumonia etc. clinically, few side effects has gastrointestinal reaction individually.

The specific embodiment

Embodiment 1

With Herba Pogostemonis 750 grams, Herba Schizonepetae 500 grams, Herba Centipedae 600 gram choppings, extract volatile oil with steam distillation, volatile oil is standby, its decocting liquid filters, medicinal residues decoct with water 1 hour again, filter, merging filtrate, concentrate standby, Fructus Xanthii 750 grams, Radix Scutellariae 750 grams, the Radix Angelicae Dahuricae 500 grams, each 250 gram of Flos Chrysanthemi and Flos Chrysanthemi Indici decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter, filtrate and above-mentioned reserve liquid merge, and being concentrated into relative density is 1.20 (80 degree), puts cold, adding ethanol makes and contains alcohol amount and reach 60%, left standstill 24-48 hour, and got supernatant, reclaim ethanol and be condensed into thick paste, dry, add Fel Sus domestica unguentum 70 grams, chlorphenamine maleate 0.6 gram, Sodium Houttuyfonate 10 grams, above-mentioned volatile oil, add 45～75% filleies such as starch or dextrin, carboxymethyl starch, calcium hydrogen phosphate or other solid medicinal adjuvants, 0.5～10% disintegrating agent carboxymethyl base sodium cellulosate, the pharmaceutic adjuvant of hydroxypropyl cellulose or other tool water swellings and lubricant such as magnesium stearate etc. have lubricated, make granule, tabletting, coating promptly get 1000 tablets of tablets.This name of product is grey goose rhinitis tablet.

Embodiment 2

With Herba Pogostemonis 650 grams, Herba Schizonepetae 400 grams, Herba Centipedae 500 gram choppings, extract volatile oil with steam distillation, volatile oil is standby, its decocting liquid filters, medicinal residues decoct with water 1 hour again, filter, merging filtrate, concentrate standby, Fructus Xanthii 650 grams, Radix Scutellariae 650 grams, the Radix Angelicae Dahuricae 400 grams, each 150 gram of Flos Chrysanthemi and Flos Chrysanthemi Indici decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter, filtrate and above-mentioned reserve liquid merge, and being concentrated into relative density is 1.20 (80 degree), puts cold, adding ethanol makes and contains alcohol amount and reach 60%, left standstill 24-48 hour, and got supernatant, reclaim ethanol and be condensed into thick paste, dry, add Fel Sus domestica unguentum 60 grams, chlorphenamine maleate 0.5 gram, Sodium Houttuyfonate 8 grams, above-mentioned volatile oil, add 40～60% starch, dextrin, carboxymethyl starch, filleies such as calcium hydrogen phosphate, 0.5～10% disintegrating agent carboxymethyl base sodium cellulosate, hydroxypropyl cellulose is made granule and is made it dry, and adds the fluidizer magnesium stearate, differential silica gel, and make it dry, in incapsulating then, obtain product.This name of product is " a grey goose capsule for treating rhinitis ".

Embodiment 3

With Herba Pogostemonis 850 grams, Herba Schizonepetae 600 grams, Herba Centipedae 700 gram choppings are extracted volatile oil with steam distillation, and volatile oil is standby, its decocting liquid filters, and medicinal residues decoct with water 1 hour again, filters, merging filtrate, concentrated standby, Fructus Xanthii 850 grams, Radix Scutellariae 850 grams, the Radix Angelicae Dahuricae 600 grams, each 350 gram of Flos Chrysanthemi and Flos Chrysanthemi Indici decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter, filtrate and above-mentioned reserve liquid merge, be concentrated into relative density and be 1.20 (80 degree), put coldly, add ethanol and make and contain the alcohol amount and reach 60%, left standstill 24-48 hour, get supernatant, reclaim ethanol and be condensed into thick paste, drying, add Fel Sus domestica unguentum 80 grams, chlorphenamine maleate 0.7 gram, Sodium Houttuyfonate 12 grams, above-mentioned volatile oil, add filler 20～90% sucrose, lactose, dextrin, starch, make granule, make it dry, obtain product.This name of product is " agent of grey goose rhinitis particle ".

Embodiment 4

With Herba Pogostemonis 800 grams, Herba Schizonepetae 550 grams, Herba Centipedae 650 gram choppings are extracted volatile oil with steam distillation, and volatile oil is standby, its decocting liquid filters, and medicinal residues decoct with water 1 hour again, filters, merging filtrate, concentrated standby, Fructus Xanthii 800 grams, Radix Scutellariae 800 grams, the Radix Angelicae Dahuricae 550 grams, each 280 gram of Flos Chrysanthemi and Flos Chrysanthemi Indici decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter, filtrate and above-mentioned reserve liquid merge, and being concentrated into relative density is 1.20 (80 degree), put cold, add ethanol and make and contain alcohol amount and reach 60%, left standstill 24-48 hour, get supernatant, reclaim ethanol and be condensed into thick paste, drying adds Fel Sus domestica unguentum 75 grams, chlorphenamine maleate 0.7 gram, Sodium Houttuyfonate 10 grams, above-mentioned volatile oil, sucrose or the Mel or the sweeting agent 0.1～3% of adding 20～65% weight obtain the oral liquid product.This name of product is " a grey goose rhinitis oral liquid ".

Embodiment 5

With Herba Pogostemonis 680 grams, Herba Schizonepetae 560 grams, Herba Centipedae 720 gram choppings, extract volatile oil with steam distillation, volatile oil is standby, its decocting liquid filters, medicinal residues decoct with water 1 hour again, filter merging filtrate, concentrate standby, Fructus Xanthii 680 grams, Radix Scutellariae 680 grams, the Radix Angelicae Dahuricae 530 grams, each 230 gram of Flos Chrysanthemi and Flos Chrysanthemi Indici decoct with water secondary, and 2 hours for the first time, 1.5 hours for the second time, filter, filtrate and above-mentioned reserve liquid merge, and being concentrated into relative density is 1.20 (80 degree), puts cold, adding ethanol makes and contains alcohol amount and reach 60%, left standstill 24-48 hour, and got supernatant, reclaim ethanol and be condensed into thick paste, dry, add Fel Sus domestica unguentum 63 grams, chlorphenamine maleate 0.7 gram, Sodium Houttuyfonate 9 grams, the above-mentioned volatile oil of Oleum menthae 0.8 gram adds excipient 10～100% white sugar or the medicinal residues xeraphium after Mel and the extraction by weight, starch is made water-honeyed pill, big honeyed pills, concentrated pill.This name of product is " a grey goose ' Biyanwan ' for treating rhinitis ".

Embodiment 6

The production method of nasal drop: with Herba Pogostemonis 720 grams, Herba Schizonepetae 640 grams, Herba Centipedae 560 gram choppings, extract volatile oil with steam distillation, volatile oil is standby, and its decocting liquid filters, medicinal residues decoct with water 1 hour again, filter, merging filtrate concentrates standby, Fructus Xanthii 670 grams, Radix Scutellariae 790 grams, the Radix Angelicae Dahuricae 490 grams, each 290 gram of Flos Chrysanthemi and Flos Chrysanthemi Indici decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter, filtrate and above-mentioned reserve liquid merge, be concentrated into relative density and be 1.20 (80 degree), put coldly, add ethanol and make and contain the alcohol amount and reach 60%, left standstill 24-48 hour, get supernatant, reclaim ethanol and be condensed into thick paste, will concentrate thick paste, volatile oil, Fel Sus domestica unguentum, chlorphenamine maleate, Sodium Houttuyfonate adds 10 times of distilled water dilutings, cross the elimination insoluble matter, bottling is sealed, and obtains product.

The relevant toxicity test of the present invention, clinical trial, pharmacology, pharmacodynamics situation:

One, the scorching sheet of the grey goose of the present invention is reported rat long term toxicity test pathological examination

The grey goose rhinitis tablet of Chinese medicine preparation provided by the invention is reported as follows the main organs histological examination result of rat long term toxicity test.

Get high dose and control rats after the drug withdrawal.After animal via is checked substantially, leave and take tissues such as the heart, liver, spleen, lung, kidney, stomach, small intestinal, adrenal gland, nasal mucosa, ovary and testis, through fixedly film-making and HE dyeing of routine, light microscopy checking then.

1, the heart: the heart outward appearance is no abnormal, and matter did not see that other materials occur between pericardium, endocardium reached, and it is dendritic that myocardial cell is branch, and nuclear is oval.

2, liver: the liver outward appearance is no abnormal.Hepatocyte is polygon, and the nuclear circle is big, visible kernel.Liver rope and sinus hepaticus are radial arrangement, the distribution of being dispersed in property of sternzellen, and central vein and portal area blood vessels at different levels and gallbladder tube structure are normal, do not see that also other materials occur.

3, spleen: all animals spleen peplos, red pulp and white pulp ratio, lymph follicle, various lymphocyte, snius lienis etc. there is no unusually, do not see that also other materials occur.

4, kidney: all form size, color and luster and the tangent plane of kidneys are normal, and kidney peplos is smooth, glomerule, renal capsule, renal tubules at different levels, renal pelvis and a matter, epithelial cell form are no abnormal, does not see that other electrodeposition substances are in tube chamber.

5, stomach: all the gastric epithelial cell form is normal, and myxocyte, chief cell and parietal cell distribute no abnormal, and flesh layer and tunicle are complete, and a matter does not have other electrodeposition substances.

6, small intestinal: all epithelium of intestinal mucosa is complete, and enteraden cell and various epithelial cell form are not seen change, and a matter, flesh layer and serous coat do not see that other materials occur.

7, lung: heavy dose of group ♀ 2 interstitial pneumonias.The lung outward appearance of all the other animals is canescence, and bronchial mucosa epitheliums at different levels do not have degeneration and come off, and tube chamber does not have other materials and occurs, and alveolar epithelium is flat, a matter no abnormality seen.

8, ovary: all the ovary outward appearance is no abnormal, and various follicles, corpus luteum, lean type and a matter do not have obvious change.

9, testis: all testis is of moderate size, the density ratio no abnormality seen of spermatogonium, spermatocyte, secondary spermatocyte and spermatid, and a matter does not obviously change.

10, adrenal gland: all adrenal gland's outward appearance is no abnormal, and cruel cell is had a liking for by cortex portion glomerular zone, zona fasciculata, reticular zone and medullary substance portion, and a matter is not seen obvious change.

11, nasal mucosa: all nasal mucosa is complete, and the epithelial cell form is normal, and matter did not see that pathologic changes between mucosa reached down.

Above result shows that the interstitial pneumonia that individual animal occurs belongs to the animal commonly encountered diseases, and is irrelevant with drug toxicity.Can think this medicine to the Mus long term toxicity test, not see that the histopathology of main organs changes.

Two, grey goose rhinitis tablet acute toxicity test

Test objective observe this product with Cmax, maximum allow three times on the one gastric infusions of administration volume after, the toxic reaction situation of animal is calculated the multiple of the suitable clinical dosage of used dosage.

Be subjected to the reagent thing: grey goose rhinitis tablet, Liuzhou Pharmaceutical Co produces.Lot number 011124, every contains medical material 4.35g, and clinical consumption is every day 3 times, each 3～4 (being made into desired concn with distilled water before the experiment).

Animal: NIH mice body weight 19～22 grams, 20, male and female half and half, Guangxi Chinese medicine institute animal housing provides.Divide sex to raise 10 in every cage.Feed the standard particle feedstuff, 23 ± 3 ℃ of laboratory temperatures, relative humidity 70 ± 5%.

Test method: undertaken by literature method.Select 20 of normal mouses for use, fasting was pressed each 40ml/kg body weight gastric infusion, three times on the one with this product after 12 hours.The situations such as activity, feces, feed and body weight of each animal change in the observed and recorded 7 days.

Result of the test: irritate stomach this product 120ml/kg (quite medical material 383g/kg) in one day, the outward appearance of mice, behavior, extremity activity, skin, feed, drainage etc. there is no unusually in 7 days, no animal dead, and body weight gain is normal.

The body weight change situation of the grey goose rhinitis tablet of subordinate list acute toxicity test (g, 7 days body weight rate of increase 383 20 20.1 ± 1.0 23.1 ± 1.7 14.9% after the body weight administration before dosage (g/kg) the number of animals administration of X ± SD)

Conclusion: give the grey goose rhinitis tablet of mouse stomach quite total medical material 383g/kg/ day, be equivalent to 440 times of clinical daily dose (0.87g/kg), do not see dead mouse.Prompting, this product should be safe by clinical plan with dosage and route of administration.

Three, grey goose rhinitis tablet long term toxicity test data

Make a summary grey goose rhinitis tablet with 104,70,35g medical material kg/d (be equivalent to respectively clinical daily dose 0.87g medical material/kg/d 120 times, 80 times, 40 times) gives the rat oral gavage administration, continuous 3 months (be equivalent to clinical course of treatment 1 month 3 times).The general performance of animal, routine blood test, hepatic and renal function, main organs histological examination do not find that this product has tangible toxic reaction to take place.

Grey goose rhinitis tablet is the Chinese medicine preparation that Liuzhou Pharmaceutical Co produces, and entrusted by manufacturer, and we carry out long term toxicity test to this product, and test report is as follows:

Test objective is investigated the continuous repeat administration of this product to the toxic reaction and the order of severity thereof that animal produced, is reference data for clinical drug use.

Be subjected to the grey goose rhinitis tablet of reagent thing, every is equivalent to medical material 4.35 grams, lot number 011124, and Liuzhou Pharmaceutical Co provides.Clinical consumption is every day three times, each 3～4.Be mixed with desired concn for using with distilled water before the experiment.Each is organized dosage and represents with medical material g/kg body weight.

Experimental animal Wistar rat, regular grade, laboratory animal room of Colleges Of Traditional Chinese Medicine Of Guangxi provides that (quality certification number: No. the 11005th, the moving word of osmanthus doctor), rat is divided the sex sub-cage rearing, feeds the standard particle material, 23 ± 3 ℃ of laboratory temperatures, relative humidity 70 ± 5%.

Test method is carried out with reference to " study of tcm new drug specification requirement " medium-term and long-term toxicity test method.Choose 80 of healthy normal rat, male and female half and half, body weight 90 ± 15g.Medication simulation this product clinical administration approach (oral) adopts gastric infusion.The dosage setting is respectively clinical daily dose, and (120 times, 80 times, 40 times of 52.2g medical material/60kg) are equivalent to total medical material 104g/kg, 70g/kg, three dosage groups of 35g/kg and a distilled water matched group.Claim body weight behind the medicine weekly one time, adjust dosage by body weight.Observe general performance such as animal feed, activity, feces and toxic reaction situation during the administration.Behind the last medicine second day, put to death 12 (each 6 of male and female) rats for every group, get that the hematology is surveyed in blood examination and blood biochemical is learned index.Survey hematological indices with BC2000 type Automatic Blood Cell Analyzer; Measure clotting time with slide method; Measure blood biochemical with FDAC 7170A type automatic clinical chemistry analyzer and learn index.And the heart, liver, spleen, lung, kidney, uterus, ovary, the testis of getting each Mus weigh, and calculates every 100g body weight corresponding organs coefficient.Leave and take the heart, liver, spleen, lung, kidney, stomach, small intestinal, adrenal gland, nasal mucosa, ovary, the testis of each Mus simultaneously and do the pathology histological examination.The drug withdrawal of residue rat observed for 2 weeks by detecting These parameters with quadrat method.Each administration group measured value and distilled water group are relatively carried out statistical analysis with t value method or correction t value method, comprehensively the expose sb.'s past misdeeds safety of valency medicine of measurement result.

Test period is 3 months (12 week) according to clinical plan with formulating the long term toxicity test time 1 month course of treatment.

Observation index 1, general performance: advance good, body weight, outward appearance behavior, activity, feces etc.

2, hematological indices: red blood cell count(RBC) (RBC), hemoglobin (HB), platelet count (PLT), numeration of leukocyte (WBC) and classification thereof: lymphocyte (LYM), medium-sized cell (MID) comprise mononuclear cell, acidophilia and basophilic granulocyte, neutrophilic granulocyte (GRA), clotting time (CT).

3, liver function index: glutamate pyruvate transaminase (ALT), glutamic oxaloacetic transaminase, GOT (AST), total serum protein (TP), albumin (ALB), globulin (Glo).

4, renal function index: carbamide negative (BUN), liver flesh (Cr).

5, other indexs: T-CHOL (T-Cho), triglyceride (TG), glucose (GLU).

6, main organs naked eyes and histological examination.

Result of the test:

1, ordinary circumstance: during the administration, each outward appearance behavior, extremity activity, feed of organizing rat is normal; The feces character be the sepia property of medicine just.Between administration and withdrawal time, rat body weight increases normal, and difference does not have significance meaning (table 1) between administration group and the normal control group.

The grey goose rhinitis tablet of table 1 long term toxication drug withdrawal 2 all rat main organs coefficient values (g/100g body weight, the group sex conscience spleen lung kidney testis uterus ovary matched group ♀ 0.39 ± 0.06 2.87 ± 0.56 0.28 ± 0.09 0.90 ± 0.24 0.32 ± 0.03 0.27 ± 0.07 of X ± SD)

Dosage ♀ 0.34 in ♂ 0.35 ± 0.03 3.02 ± 0.22 0.31 ± 0.03 0.71 ± 0.10 0.32 ± 0.03 0.37 ± 0.09 high dose ♀ 0.36 ± 0.04 2.74 ± 0.58 0.23 ± 0.05 0.80 ± 0.19 0.31 ± 0.06 0.31 ± 0.04104g/kg ♂ 0.38 ± 0.10 2.92 ± 0.64 0.30 ± 0.08 0.75 ± 0.18 0.30 ± 0.06 0.33 ± 0.20 ± 0.03 2.78 ± 0.50 0.28 ± 0.06 0.93 ± 0.27 0.38 ± 0.08 0.34 ± 0.22-0g/kg ♂ 0.36 ± 0.03 2.80 ± 1.29 0.24 ± 0.24 0.81 ± 0.19 0.34 ± 0.13 0.30 ± 0.30 low dosage ♀ 0.38 ± 0.04 2.91 ± 0.53 0.27 ± 0.03 0.77 ± 0.03 0.37 ± 0.05 0.33 ± 0.0635g/kg ♂ 0.35 ± 0.04 2.89 ± 0.35 0.27 ± 0.03 0.75 ± 0.13 0.35 ± 0.04 0.36 ± 0.06

Conclusion: grey goose rhinitis tablet is with 104,70 and 35g medical material/kg/d level rat oral gavage, continuous 12 weeks, rat generally in order, body weight gain is normal; Hematological examination, blood biochemical are learned and the organ coefficient inspection, and difference does not have the significance meaning between administration group and the matched group; The obvious pathological change that causes because of drug toxicity is not seen by the histopathologic examination of main organs.The grey goose rhinitis tablet of above results suggest should be safe by using dosage, approach and the course of treatment of clinical plan usefulness.

Grey goose rhinitis tablet clinical research testing data

The grey goose rhinitis tablet treatment of the present invention stuffy nose, allergic rhinitis, nasal sinusitis clinical observation are summed up

Grey goose rhinitis tablet system has heat-clearing and toxic substances removing, the effect that dispelling wind is sensible according to the Chinese medicine preparation that traditional traditional Chinese medical science pharmacology letter paper and experience develop.According to " provisions for new drugs approval ", " otorhinolaryngology of Chinese medicine ", " traditional Chinese medical science disease diagnosis criterion of therapeutical effect ", " new Chinese medicine clinical guidance principle ", by first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi, 160 examples, second Affiliated Hospital of the college of traditional Chinese medicine, 160 example and Nationality Hospital of Guangxi Zhuang Autonomous Region's 160 examples, in February, 2002～May grey goose rhinitis tablet has been carried out clinical verification, now the result has been summarized as follows:

Research purpose

By clinical observation, further investigate the curative effect of grey goose rhinitis tablet treatment stuffy nose (chronic simple rhinitis), nose allergic rhinitis, nasal sinusitis (sinusitis) and to the safety of human body.

Object and method

One, diagnostic criteria

(1) Western medicine diagnose standard

1, chronic rhinitis

(1) with the long-term nasal obstruction that continues, or intermittent, property nasal obstruction alternately, the nasal mucus amount mostly is cardinal symptom, or with dizziness, insomnia, tinnitus, the inaccessible sense of in ear.

(2) course of disease is longer, tired, flu back sx, easy concurrent bulge of the ear, deafness.

(3) nasal mucosa hyperemia is Yue Se or kermesinus, and concha nasalis inferior swelling shows smooth moisteningly, is kermesinus.The soft high resilience of mucosa depression can occur with the probe compressing, removes probe and recovers present situation immediately, and behind the external ephedrine liquid, mucosa shrinks.

2, allergic rhinitis

(1) allergic constitution has the former history of contact allergy, can be divided into two kinds of long-term property and seasonalities.

(2) outbreak suddenly, paroxysmal rhinocnesmus, nasal obstruction and connect sneeze as the ball have a large amount of watery secretion, sometimes with asthma, urticaria etc.

(3) the pale or purple ash of nasal cavity and turbinate mucosa, edema, in, Carapax et Plastrum Testudinis is particularly evident, often becomes or polyp with middle nasal concha and inferior nasal meatus polypoid, nasal cavity has volume water sample or thin viscous secretion.

(4) can find the volume oxyphil cell in the nasal discharge, tuerculoderma can be positive.

3, acute sinusitis

(1) with a large amount of viscosity or purulence nasal mucus, nasal obstruction, headache or giddy are cardinal symptom.Acute sinusitis occur together heat and general malaise.

(2) the acute sinusitis morbidity is rapid, and the course of disease is shorter.If treatment is not thorough, then transfer chronic sinusitis to.

(3) nasal cavity is checked mucous hyperemia, swelling, and nasal cavity or choana have more viscosity or purulent secretion.

(4) X line nasal sinuses is taken the photograph sheet positive performance.Blood leukocytes sum and centriole cell increase during acute attack.

(2) tcm diagnosis standard

1, stuffy nose (qi depression to blood stasis disease): the swollen real color of concha nasalis is dark, is the Fructus Mori sample, continuous nasal obstruction, and tears are many or yellow thick, or sticking white, baryo,dmia, language is not smooth, cough ant phlegm, tinnitus is not clever, red tongue or petechia is arranged, stringy and thready pulse.

2, allergic rhinitis (deficiency of the lung heresy is attacked disease): rhinocnesmus, sneeze connects, the then snivel that continues, it is obstructed to have a stuffy nose, and hyposmia is easily caught a cold, and do not heal repeatedly, or spontaneous perspiration is arranged, pallor, pale tongue, tongue is white, weak pulse.

3, nasal sinusitis (wind and heat in the lung meridian): nasal obstruction, the white or little Huang of tears polychrome, headache, cough is coughed up phlegm, concha nasalis enlargement, thin white fur of tongue, floating and rapid pulse.

Two, test case standard

1, includes standard in: meet one of following condition person, all can include the object of observation in.

(1) Chinese medical discrimination belongs to the chronic simple rhinitis patient of qi depression to blood stasis disease stuffy nose.

(2) Chinese medical discrimination belongs to the Allergic Rhinitis that deficiency of the lung heresy is attacked the disease allergic rhinitis.

(3) traditional Chinese medical science distinguishes that disease belongs to the acute sinusitis patient of wind and heat in the lung meridian disease nasal sinusitis.

2, exclusion standard

(1) gestation or women breast-feeding their children are to this medicine allergy sufferers more than 18 years old or over-65s the age.

(2) be associated with serious primary disease such as cardiovascular, liver, kidney and hemopoietic system, psychotic.

(3) do not meet the standard of including in, not medication in accordance with regulations can't be judged that curative effect or data are not congruent to affect the treatment or safety judgement person.

(4) used similar medicine before the test, judgement person affects the treatment.

Three, observational technique: adopt district's group at random, contrast, non-blind method observe

1, grouping: observe 480 examples altogether, look into the digital random permutation table, treatment group and matched group were by 3: 3 district's group random packet.

Table 1 checking unit and task are distributed

Chronic rhinitis allergic rhinitis acute sinusitis

30 30 40 30 30 Nationality Hospital of Guangxi Zhuang Autonomous Region 40 30 30 30 30 of second affiliated hospital of 30 30 30 30 40 Colleges Of Traditional Chinese Medicine Of Guangxis of first affiliated hospital of the open group of the open group for the treatment of group control group treatment group control group open group treatment group control group Colleges Of Traditional Chinese Medicine Of Guangxi

2, the consumption course of treatment and medication

(1) treatment group and open treatment group: the grey goose rhinitis tablet that uses Liuzhou Pharmaceutical Co to produce, oral, one time 4, taking medicine after meal.

(2) matched group: the anti-root of Dahurian angelica rhinitis tablet that uses Yulin Pharmaceutic Factory, Gangxi Autonomous Region to produce, authentication code: ZZ-2919-defends in osmanthus the accurate word [1985] of medicine No. 027040, and is oral, one time 5, every day 3 times, taking medicine after meal.

(3) course of treatment: stuffy nose and allergic rhinitis are 4 weeks (only observing short term effect), and acute nasal sinusitis is 7 days.

(4) viewing duration need not be treated the other drug of primary disease.

Four, observation standard

(1) safety observation

1, general health check-up project;

2, blood, routine urianlysis;

3, the heart, liver, kidney function test.

(2) health giving quality observation

(1) variation of related symptoms, sign.

(2) temperature taking.

Five, see disease light and heavy degree grouping standard and scoring method, see Table 2.

Table 2 sees that disease light and heavy degree grade scale and slight (2 minutes) moderate (4 minutes) severe (6 minutes) headache of scoring method witness gently do not influence the movable outbreak that is interrupted, still can participation activity severe pain, can not participation activity rhinalgia light, idol has more very, ventilation is obviously poor heavy, almost whole day is spoken in a low voice with mouthful 〉=10 rhinocnesmus sprays of 〉=5 appearance every day of 〉=2 appearance every day of suction watery nasal discharge appearance every day, and 〉=15 hyposmia of 〉=10 appearance every days of 〉=3 appearance every day of appearance every day are blunt obviously to go down 37.1 ℃～37.5 ℃～38 ℃ 38 ℃～nasal mucosas hyperemia of disappearance heating gently, no swelling more very, mild swelling is congested heavy, obviously swelling first mucosal pallor is light, color is very gloomy, the light white weight of color, the swelling of the pale concha nasalis swelling of color Carapax et Plastrum Testudinis, in every Carapax et Plastrum Testudinis with at the bottom of near Carapax et Plastrum Testudinis and nose, in every near can not see

And the still visible Carapax et Plastrum Testudinis of first with in be separated with in the slit first or middle first mucosal polyp sample becomes

Six, curative effect determinate standard

1, stuffy nose

(1) produce effects: transference cures such as nasal obstruction, watery nasal discharge, the nasal cavity inspection is normal

(2) effective: sxs such as nasal obstruction, watery nasal discharge, local body obviously improves

(3) invalid: as not reach effective standard.

2, allergic rhinitis

(1) produce effects: symptom and disappearance such as sneeze, watery nasal discharge, nasal obstruction or improve 2 grades;

(2) effective: symptom such as sneeze, watery nasal discharge, nasal obstruction and sign disappear or improve 1 grade;

(3) invalid: as not reach effective standard.

3, nasal sinusitis

(1) cure: transference cure, X line nasal sinuses sheet are no abnormal;

(2) take a turn for the better: tables such as symptom is obviously improved, hyperemia is seen in the nasal cavity inspection, mucosa swelling are seen and are alleviated.X line nasal sinuses is taken the photograph sheet and is had clear improvement;

(3) invalid: sings and symptoms does not have improvement.

Case: Zhao * *, the male, 19 years old, the student, readme did not have obviously thoroughly because of headache, nasal obstruction, a large amount of viscosity nasal mucus of stream, the heat that occurs together, cough, thirsty, malaise occurring in prescription on individual diagnosis on March 17th, 2002 in 3 days for excuse pain, nasal obstruction, a large amount of viscosity nasal mucus of stream.Look into: T37.8 ℃, R, P, BP are no abnormal, cardiopulmonary and abdomen examination no abnormality seen, nasal cavity inspection: the viscous secretion that mucous hyperemia, swelling, nasal cavity are effectively many, X line nasal sinuses sheet (+), Biood-Rt:Hb138g/L, RBC4.5 * 10 ¹²/ L, WBC8.8 * 10 ⁹/ L, N84%, body of the tongue line, white and thin fur, floating and rapid pulse, liver, kidney function test ().Tcm diagnosis: nasal cavity and X line nasal obstruction hole sheet are checked no abnormal, and routine blood test and hepatic and renal function are checked no abnormality seen.Efficacy evaluation: recovery from illness.

Discuss and conclusion

1,300 routine patient's Clinical results are shown through three tame hospitals such as first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi grey goose rhinitis tablet has heat-clearing and toxic substances removing, the function that dispelling wind is sensible, it is safe and effective to be used for the treatment of stuffy nose, allergic rhinitis, nasal sinusitis etc.

2, recent cure rate is organized in the nasal sinusitis treatment, effective percentage is respectively 50.00%, 39.00%, total effective rate is 89.00%, contrast matched group recent cure rate, effective percentage be respectively 43.33%, 43.33%,, total effective rate is 86.67%, two group of relatively there was no significant difference; Stuffy nose treatment group obvious effective rate, effective percentage are respectively 56.00% and 37.00%, and total effective rate is 93.00%, and matched group obvious effective rate, effective percentage are respectively 53.33% and 35.00, and total effective rate is 88.33%, two group of relatively there was no significant difference; Allergic rhinitis treatment group obvious effective rate, effective percentage are respectively 54.00% and 37.00%, and total effective rate is 91.00%, and matched group obvious effective rate, effective percentage are respectively 53.33% and 38.33, and total effective rate is 91.67%, two group and compares there was no significant difference.Prompting: the clinical efficacy of the grey treatment of goose rhinitis tablet nasal sinusitis, stuffy nose and allergic rhinitis is better, and control drug is similar respectively to separately.

3, the clinical symptoms efficacy result shows, symptoms such as nasal obstruction, watery nasal discharge, headache, heating, nasal mucosa hyperemia all have clear improvement after two groups of patient of nasal sinusitis, but two groups are compared there was no significant difference; Symptoms such as nasal obstruction, watery nasal discharge, rhinocnesmus sneeze, baryo,dmia, nasal mucosa hyperemia and concha nasalis swelling all have clear improvement after two groups of patient of stuffy nose, two kinds of diseases of allergic rhinitis, but two groups are compared there was no significant difference.The clinical symptoms of pointing out grey goose rhinitis tablet can obviously improve nasal sinusitis, stuffy nose and allergic rhinitis, and control drug is similar respectively to separately.

4, through 300 routine patients have been carried out blood, just routine examination, the heart, liver, kidney function test are not all found obvious adverse reaction and toxic and side effects, and prompting this product is clinical safe and reliable.

Grey goose rhinitis tablet treatment stuffy nose, allergic rhinitis, nasal sinusitis clinical observation brief summary

Clinical trial unit: first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi

The Chinese medicine preparation that grey goose rhinitis tablet system develops according to traditional Chinese medical theory and experience has heat-clearing and toxic substances removing, and the function that dispelling wind is sensible is used for that wind heat is accumulate poison and diseases such as the stuffy nose that causes, allergic rhinitis, nasal sinusitis.My institute was observed 160 routine stuffy noses, allergic rhinitis, nasal sinusitis patient year May in February, 2002 to 2002, and brief summary is as follows as a result:

Object and method

Diagnostic criteria, the observation of including standard, case grouping, drug usage and consumption, observation item and method, curative effect determinate standard, untoward reaction in and the statistical processing of the definite qualified study subject of this checking are all implemented by " grey goose rhinitis tablet clinical observation scheme ".

1, grouping: observe 160 examples altogether, wherein stuffy nose 60 examples, allergic rhinitis 60 examples, nasal sinusitis 40 examples.3: 3 districts of the equal ammonium of treatment group and matched group group random packet, 100 examples, matched group 60 examples are organized in treatment.

2, usage, the course of treatment and medication

(1) treatment group: 100 examples.The grey goose rhinitis tablet that Liuzhou Pharmaceutical Co produces, oral, each 4, every day 3 times, taking medicine after meal.

(2) matched group: 60 examples.The anti-root of Dahurian angelica rhinitis tablet that uses Yulin pharmaceutical factory to produce, [authentication code ZZ-219-defends in osmanthus the accurate word (1985) of medicine No. 027040], oral, one time 5, every day 3 times, taking medicine after meal.

Case: Liu * *, the woman 28 years old, lives West China, Nanning City road No. 108.Because of stuffy nose is itched, having a stuffy nose breaks out, sneeze connects ball 2 days and goes to a doctor on April 16th, 2002.When health is swept in patient's readme, rhinocnesmus, the nasal obstruction break out, sneeze connects ball, watery nasal discharge, shed tears, hyposmia.Allergic rhinitis medical history, easy catching a cold are previously arranged.Look into: T, R, P, BP are all normal, cardiopulmonary and abdominal part no abnormality seen.Nasal cavity is checked: the pale edema of nasal cavity and turbinate mucosa, and You Yizhong, concha nasalis inferior are obvious, and nasal cavity is seen thin viscous secretion.Skin anaphylactic test (one), routine blood test: Hb150g/L, RBC5.4 * 10 ¹²/ L, WBC6.6 * 10 ⁹/ L, a little less than pale tongue, the tongue the lung-pulse, tcm diagnosis: allergic rhinitis (deficiency of the lung heresy is attacked disease).Western medicine diagnose: allergic rhinitis, promptly in advance with grey goose rhinitis tablet, oral, each 4, every day 3 times is around the logotype medicine.Medication 1 all nasal obstructions, watery nasal discharge, sneeze disappear substantially, continue around the medication extremely, and all diseases disappear, and the nasal cavity inspection: the turbinate mucosa edema disappears substantially, does not have obvious viscous secretion, routine blood test: Hb150g/L, RBC5.4 * 10 ¹²/ L, WBC6.0 * 10 ⁹/ L.Efficacy evaluation: produce effects.

Discuss and conclusion

1, stuffy nose treatment group obvious effective rate, effective percentage are respectively 56.67%, 36.67%, and total effective rate is 93.33%; Matched group obvious effective rate, effective percentage are respectively 50.00%, 36.67%, and total effective rate is 86.67%, two group of relatively there was no significant difference.Allergic rhinitis treatment group obvious effective rate, effective percentage are respectively 56.67%, 36.67%, and total effective rate is 93.33%, and matched group obvious effective rate, effective percentage are respectively 50.00%, 40.00%, and total effective rate is 90.00%, two group of relatively there was no significant difference.The open group of nasal sinusitis cure rate is 45.00%, and effective percentage is 45.00%, and total effective rate is 90.00%.Prompting: the clinical efficacy of grey goose rhinitis tablet treatment stuffy nose, allergic rhinitis, nasal sinusitis is similar to the contrast medicine respectively.

2, the clinical symptoms efficacy result shows, symptoms such as nasal obstruction, watery nasal discharge, rhinocnesmus sneeze, baryo,dmia, nasal mucosa hyperemia, concha nasalis swelling all have clear improvement after two groups of patient of stuffy nose, but two groups are compared there was no significant difference; After two groups of patient of allergic rhinitis diseases such as nasal obstruction, watery nasal discharge, rhinocnesmus sneeze, hyposmia, first mucosal pallor, concha nasalis swelling all to have bright be to improve; Diseases such as nasal obstruction, watery nasal discharge, headache, heating, nasal mucosa hyperemia, concha nasalis swelling all have clear improvement after the nasal sinusitis patient.Prompting: grey goose rhinitis tablet can improve obviously that stuffy nose, fault are had a stuffy nose, nasal sinusitis patient's clinical symptoms, and similar to corresponding matched group medicine respectively.

3, this research has been carried out blood, urine, just routine examination to 100 routine patients, and the heart, liver, kidney function test are not all found obvious adverse reaction and toxic and side effects, and prompting: this product is clinical safe and reliable.

The grey goose rhinitis tablet treatment of the present invention stuffy nose, allergic rhinitis, nasal sinusitis clinical observation brief summary

Test unit: two attached institutes of Colleges Of Traditional Chinese Medicine Of Guangxi

The Chinese medicine preparation that grey goose rhinitis tablet system develops according to traditional Chinese medical theory and experience has heat-clearing and toxic substances removing, and the function that dispelling wind is sensible is used for that wind heat is accumulate poison and diseases such as the stuffy nose that causes, allergic rhinitis, nasal sinusitis.Entrusted by the factory director, my institute was observed 60 routine stuffy noses, allergic rhinitis, nasal sinusitis patient year May in February, 2002 to 2002, and brief summary is as follows as a result:

Object and method

This checking is determined qualifiedly all implemented by " grey goose rhinitis tablet clinical observation scheme " by the diagnostic criteria of object, the observation of including standard, case grouping, drug usage and consumption, observation item and method, curative effect determinate standard, untoward reaction in and statistical processing.

1, grouping: observe 160 examples altogether, wherein stuffy nose 60 examples, allergic rhinitis 40 examples, nasal sinusitis 60 examples.Treatment group and matched group are all by 3: 3 district's group random packet, and 100 examples, matched group 60 examples are organized in treatment.

2, consumption, the course of treatment and medication

Case: the side * *, man, 27 years old, people from Nanning City.Excuse pain, nasal obstruction, a large amount of viscosity nasal mucus of stream 5 days were gone to a doctor on April 10th, 2002.Headache, nasal obstruction, a large amount of viscosity nasal mucus of stream, the heat that occurs together, cough, general malaise appear in 5 days cause flu of readme back.Look into: T37.6 ℃, R, P, Bp are all normal, and cardiopulmonary are checked OB, the abdomen examination no abnormality seen, and the nasal cavity inspection: mucous hyperemia, swelling, the nasal cavity choana has more viscous secretion, the performance that is positive of X line nasal sinuses sheet, routine blood test: Hb135g/L, RBC5.2 * 10 ¹²/ L, WBC8.8 * 10 ⁹/ L, N85%, light red, the white and thin fur of body of the tongue, floating and rapid pulse, tcm diagnosis: nasal sinusitis (wind and heat in the lung meridian).Western medicine diagnose: acute sinusitis, promptly give grey goose rhinitis tablet, oral, each 4, every day 3 times, logotype 7 days, took medicine 2 days, diseases such as headache, nasal obstruction, watery nasal discharge obviously alleviate, and take medicine 5 days, and the cardinal symptom sign disappears, check after taking medicine 7 days, all diseases disappear, nasal cavity inspection, routine blood test and X line nasal sinuses sheet Non Apparent Abnormality, liver, renal function no abnormality seen.Efficacy evaluation: recovery from illness.

Discuss and conclusion

1, remarkable efficient is organized in the treatment of nose chamber, effective percentage is respectively 56.67%, 36.67%, and total effective rate is 93.33%; Matched group obvious effective rate, effective percentage are respectively 56.67%, 33.33%, and total effective rate is 90.00%, two group of relatively there was no significant difference.Nasal sinusitis treatment group cure rate, effective percentage are respectively 53.33%, 33.33%, and total effective rate is 86.67%, and matched group cure rate, effective percentage are respectively 36.67%, 50.00%, and total effective rate is 86.67%, two group of relatively there was no significant difference.Allergic rhinitis open treatment group obvious effective rate, effective percentage are respectively 52.50%, 37.50%, and total effective rate is 90.00%.Prompting: the clinical efficacy of grey goose rhinitis tablet treatment stuffy nose, allergic rhinitis, nasal sinusitis is similar to the contrast medicine respectively.

2, the clinical symptoms efficacy result shows, symptoms such as nasal obstruction, watery nasal discharge, rhinocnesmus sneeze, baryo,dmia, nasal mucosa hyperemia, concha nasalis swelling all have clear improvement behind two groups of human therapies of stuffy nose; Symptoms such as nasal obstruction, watery nasal discharge, headache, heating, nasal mucosa hyperemia, concha nasalis swelling all have clear improvement after two groups of patient of nasal sinusitis; Symptoms such as nasal obstruction, watery nasal discharge, rhinocnesmus sneeze, hyposmia, first mucosal pallor, concha nasalis swelling all have clear improvement after the allergic rhinitis patient.Prompting: grey goose rhinitis tablet can obviously improve stuffy nose, allergic rhinitis, nasal sinusitis patient's clinical symptoms, and similar to corresponding matched group medicine respectively.

3, this research to 100 routine patients carried out hematuria, just, routine examination, the heart, liver, kidney function test are not all found obvious adverse reaction and toxic and side effects, the prompting this product clinical safe and reliable.

Test unit: the Chinese medicine preparation that grey goose rhinitis tablet system of Nationality Hospital of Guangxi Zhuang Autonomous Region develops according to traditional Chinese medical theory and experience, have heat-clearing and toxic substances removing, the function that dispelling wind is sensible is used for that wind heat is accumulate poison and diseases such as the stuffy nose that causes, allergic rhinitis, nasal sinusitis.My institute was observed 160 routine stuffy noses, allergic rhinitis, nasal sinusitis patient year May in February, 2002 to 2002, and brief summary is as follows as a result:

Object and method

1, grouping: observe 160 examples altogether, wherein stuffy nose 40 examples, allergic rhinitis 60 examples, nasal sinusitis 60 examples.Treatment group and matched group are all by 3: 3 district's group random packet, and 100 examples, matched group 60 examples are organized in treatment.

2, consumption, the course of treatment and medication

Case: Cao *, woman, 28 years old, people from Nanning City.Because of rhinocnesmus, nasal obstruction break out, sneeze connects ball 2 days and goes to a doctor on March 10th, 2002.Because of after hearing paint-like flavour, rhinocnesmus, nasal obstruction break out the patient at present, and sneeze connects ball, watery nasal discharge, sheds tears, hyposmia, promptly toward allergic rhinitis medical history, easy catching a cold are arranged.Look into: T, R, P, BP are all normal, cardiopulmonary and raw meat portion no abnormality seen, and the nasal cavity inspection: the pale edema of nasal cavity and turbinate mucosa, You Yizhong, concha nasalis inferior are obvious, and nasal cavity is seen thin viscous secretion.Skin anaphylactic test: (+), routine blood test: Hb140g/L, RBC5.0 * 10 ¹²/ L, WBC6.0 * 10 ⁹/ L, a little less than pale tongue, the tongue the lung-pulse, tcm diagnosis: allergic rhinitis (deficiency of the lung heresy is attacked card).Western medicine diagnose: allergic rhinitis, promptly give grey goose rhinitis tablet, oral, each 4, every day 3 times.In 1 week of medication, stuffy nose, watery nasal discharge, sneeze disappear substantially, continue around the medication extremely, and all diseases disappear, and the nasal cavity inspection: the turbinate mucosa edema disappears substantially, does not have obvious viscous secretion, routine blood test: Hb140g/L, RBC5.0 * 10 ¹²/ L, WBC6.0 * 10 ⁹/ L.Efficacy evaluation: recovery from illness.

Discuss and conclusion

1, nasal sinusitis treatment group cure rate, effective percentage are respectively 53.33%, 36.67%, and total effective rate is 90.00%; Matched group cure rate, effective percentage are respectively 50.00%, 36.67%, and total effective rate is 86.67%, two group of relatively there was no significant difference.Allergic rhinitis treatment group obvious effective rate, effective percentage are respectively 53.33%, 36.67%, and total effective rate is 90.00%, and matched group obvious effective rate, effective percentage are respectively 56.67%, 36.67%, and total effective rate is 93.33%, two group of relatively there was no significant difference.The open group of stuffy nose obvious effective rate is 55.00%, and effective percentage is 37.50%, and total effective rate is 92.50%.Prompting: the clinical efficacy of grey goose rhinitis tablet treatment stuffy nose, allergic rhinitis, nasal sinusitis is similar to the contrast medicine respectively.

2, the clinical symptoms efficacy result shows, symptoms such as nasal obstruction, watery nasal discharge headache, heating, nasal mucosa hyperemia, concha nasalis swelling all have clear improvement behind two groups of human therapies of nasal sinusitis; Symptoms such as nasal obstruction, watery nasal discharge, rhinocnesmus sneeze, hyposmia, first mucosal pallor, concha nasalis swelling all have clear improvement after the allergic rhinitis patient; Symptoms such as nasal obstruction, watery nasal discharge, rhinocnesmus sneeze, baryo,dmia, nasal mucosa hyperemia, concha nasalis swelling all have clear improvement after the stuffy nose patient.Prompting: grey goose rhinitis tablet can obviously improve nasal sinusitis, allergic rhinitis, stuffy nose patient's clinical symptoms, and similar to corresponding matched group medicine respectively.

Medicine of the present invention is through second Affiliated Hospital of the college of traditional Chinese medicine, first Affiliated Hospital of Colleges Of Traditional Chinese Medicine Of Guangxi and the Guangxi hospitals of ethnic minority medicine carry out clinical verification to 300 routine nasal sinusitis, nasal obstruction, allergic rhinitis patient, wherein, recent cure rate is organized in the nasal sinusitis treatment, effective percentage is respectively 50% and 39%, total effective rate is 89%, nasal obstruction treatment group obvious effective rate, effective percentage are respectively 56% and 37%, total effective rate is 93%, allergic rhinitis treatment group obvious effective rate, effective percentage are respectively 54% and 37%, total effective rate is 91%, does not find untoward reaction in the clinical course.

Claims

1, a kind of Chinese medicine preparation for the treatment of acute and chronic rhinitis comprises Fructus Xanthii, Herba Centipedae, it is characterized in that: the composition and the weight percentage of its raw material are as follows:

Fructus Xanthii 10-20 Radix Scutellariae 10-20

Herba Pogostemonis 10-20 Herba Centipedae 10-18

Radix Angelicae Dahuricae 8-15 Herba Schizonepetae 8-15

Flos Chrysanthemi 2-8 Flos Chrysanthemi Indici 2-8

Fel Sus domestica unguentum 0.5-4 chlorphenamine maleate 0.01-0.04

Sodium Houttuyfonate 0.1-0.5 Oleum menthae 0.01-0.06

2, the Chinese medicine preparation of treatment acute and chronic rhinitis according to claim 1 is characterized in that: its dosage form is tablet or granule, capsule, oral liquid, pill, nasal drop.

3, a kind of production method for the treatment of the Chinese medicine preparation of acute and chronic rhinitis is characterized in that: the preparation of tablet is: with Herba Pogostemonis, Herba Schizonepetae, the Herba Centipedae chopping is extracted volatile oil with steam distillation, volatile oil is standby, and its decocting liquid filters, and medicinal residues decoct with water 1 hour again, filter, merging filtrate concentrates standby, Fructus Xanthii, Radix Scutellariae, the Radix Angelicae Dahuricae, Flos Chrysanthemi and Flos Chrysanthemi Indici decoct with water secondary, and 2 hours for the first time, 1.5 hours for the second time, filter, filtrate and above-mentioned reserve liquid merge, and being concentrated into relative density is 1.20 (80 degree), puts cold, adding ethanol makes and contains alcohol amount and reach 60%, left standstill 24-48 hour, and got supernatant, reclaim ethanol and be condensed into thick paste, dry, add Fel Sus domestica unguentum, chlorphenamine maleate, Sodium Houttuyfonate, above-mentioned volatile oil, add adjuvant again, make tablet, obtain product;

Described adjuvant comprises filler, disintegrating agent, and filler is starch, dextrin, carboxymethyl starch, calcium hydrogen phosphate and other pharmaceutic adjuvants; Disintegrating agent is sodium carboxymethyl cellulose, hydroxypropyl cellulose and pharmaceutic adjuvant with water swelling; Lubricant is the pharmaceutic adjuvant of Polyethylene Glycol, magnesium stearate, Pulvis Talci and tool lubrication, and wherein the weight content of filler, disintegrating agent is respectively: 45～75%, 0.5～10%, and the lubricant weight content is: 0.5～10%.

4, a kind of production method for the treatment of the Chinese medicine preparation of acute and chronic rhinitis is characterized in that: capsular preparation is: with Herba Pogostemonis, Herba Schizonepetae, the Herba Centipedae chopping is extracted volatile oil with steam distillation, volatile oil is standby, and its decocting liquid filters, and medicinal residues decoct with water 1 hour again, filter, merging filtrate, concentrated standby, Fructus Xanthii, Radix Scutellariae, the Radix Angelicae Dahuricae, Flos Chrysanthemi and Flos Chrysanthemi Indici decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter, filtrate and above-mentioned reserve liquid merge, being concentrated into relative density is 1.20 (80 degree), put coldly, add ethanol and make and contain alcohol amount and reach 60%, left standstill 24-48 hour, get supernatant, reclaim ethanol and be condensed into thick paste, drying adds Fel Sus domestica unguentum, chlorphenamine maleate, Sodium Houttuyfonate, above-mentioned volatile oil adds filler, disintegrating agent and fluidizer, and make it dry, or make granule or make micropill, in incapsulating then, obtain product;

Described filler is starch, dextrin, carboxymethyl starch, calcium hydrogen phosphate and other pharmaceutic adjuvants; Described disintegrating agent is sodium carboxymethyl cellulose, hydroxypropyl cellulose and pharmaceutic adjuvant with water swelling; Described fluidizer is that magnesium stearate, differential silica gel and other have the pharmaceutic adjuvant of fluidizer effect.Filler, disintegrating agent, fluidizer weight content are: 30～70%, 0.5～20%, 0.5～5%.

5, a kind of production method for the treatment of the Chinese medicine preparation of acute and chronic rhinitis, it is characterized in that: the preparation of pill is: with Herba Pogostemonis, Herba Schizonepetae, the Herba Centipedae chopping, extract volatile oil with steam distillation, volatile oil is standby, and its decocting liquid filters, and medicinal residues decoct with water 1 hour again, filter, merging filtrate, concentrated standby, Fructus Xanthii, Radix Scutellariae, the Radix Angelicae Dahuricae, Flos Chrysanthemi and Flos Chrysanthemi Indici decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter, filtrate and above-mentioned reserve liquid merge, being concentrated into relative density is 1.20 (80 degree), put coldly, add ethanol and make and contain alcohol amount and reach 60%, left standstill 24-48 hour, get supernatant, reclaim ethanol and be condensed into thick paste, drying adds Fel Sus domestica unguentum, chlorphenamine maleate, Sodium Houttuyfonate, above-mentioned volatile oil adds excipient 10～100% white sugar or the medicinal residues xeraphium after Mel and the extraction by weight, starch is made water-honeyed pill, big honeyed pills, the concentrated pill product.

6, a kind of production method for the treatment of the Chinese medicine preparation of acute and chronic rhinitis is characterized in that: the preparation of granule is: with Herba Pogostemonis, Herba Schizonepetae, the Herba Centipedae chopping is extracted volatile oil with steam distillation, volatile oil is standby, and its decocting liquid filters, and medicinal residues decoct with water 1 hour again, filter, merging filtrate concentrates standby, Fructus Xanthii, Radix Scutellariae, the Radix Angelicae Dahuricae, Flos Chrysanthemi and Flos Chrysanthemi Indici decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter, filtrate and above-mentioned reserve liquid merge, be concentrated into relative density and be 1.20 (80 degree), put coldly, add ethanol and make and contain the alcohol amount and reach 60%, left standstill 24-48 hour, get supernatant, reclaim ethanol and be condensed into thick paste, drying, add Fel Sus domestica unguentum, chlorphenamine maleate, Sodium Houttuyfonate, above-mentioned volatile oil, add white sucrose, lactose, dextrin, starch or pharmaceutic adjuvant 30～75% obtain product.

7, a kind of production method for the treatment of the Chinese medicine preparation of acute and chronic rhinitis is characterized in that: the preparation of oral liquid is: with Herba Pogostemonis, Herba Schizonepetae, the Herba Centipedae chopping is extracted volatile oil with steam distillation, volatile oil is standby, and its decocting liquid filters, and medicinal residues decoct with water 1 hour again, filter, merging filtrate concentrates standby, Fructus Xanthii, Radix Scutellariae, the Radix Angelicae Dahuricae, Flos Chrysanthemi and Flos Chrysanthemi Indici decoct with water secondary, 2 hours for the first time, 1.5 hours for the second time, filter, filtrate and above-mentioned reserve liquid merge, be concentrated into relative density and be 1.20 (80 degree), put coldly, add ethanol and make and contain the alcohol amount and reach 60%, left standstill 24-48 hour, get supernatant, reclaim ethanol and be condensed into thick paste, drying, add Fel Sus domestica unguentum, chlorphenamine maleate, Sodium Houttuyfonate, above-mentioned volatile oil, add sucrose, Mel, or sweeting agent, antiseptic obtains product.

8, a kind of production method for the treatment of the Chinese medicine preparation of acute and chronic rhinitis is characterized in that: the preparation of nasal drop is: with Herba Pogostemonis, Herba Schizonepetae, the Herba Centipedae chopping is extracted volatile oil with steam distillation, volatile oil is standby, and its decocting liquid filters, and medicinal residues decoct with water 1 hour again, filter, merging filtrate concentrates standby, Fructus Xanthii, Radix Scutellariae, the Radix Angelicae Dahuricae, Flos Chrysanthemi and Flos Chrysanthemi Indici decoct with water secondary, and 2 hours for the first time, 1.5 hours for the second time, filter, filtrate and above-mentioned reserve liquid merge, and being concentrated into relative density is 1.20 (80 degree), puts cold, adding ethanol makes and contains alcohol amount and reach 60%, left standstill 24-48 hour, and got supernatant, reclaim ethanol and be condensed into thick paste, add Fel Sus domestica unguentum, chlorphenamine maleate, Sodium Houttuyfonate adds 10 times of distilled water dilutings, the elimination insoluble matter, bottling is sealed, and obtains product.