CN1839950A - Coryza-treating pharmaceutical compositions and its preparing process and uses - Google Patents

Abstract

The invention relates to a traditional Chinese preparation for treating rhinitis, its preparing process and use thereof, wherein the preparation comprises astragalus root 0.1-99.9%, root of large-flowered skullcap 0.1-99.9%, asarum herb 0.1-99.9%, cimicifuga rhizome 0.1-99.9%, Flos Echinopsis latifolii 0.1-99.9%, Woodfordia fruticos 0.1-99.9%, and medicinal adjuvant 99.9-0.1%.

Description

A kind of drug regimen, preparation technology and purposes for the treatment of coryza

Technical field: the present invention relates to a kind of medicine (have another name called: the nose peace is relaxed, hereinafter to be referred as the easypro medicine of nose peace) combination and preparation technology and purposes for the treatment of coryza, belong to Chinese patent drug technique field.

Background technology: rhinitis is a kind of commonly encountered diseases, frequently-occurring disease, patient colony is very huge, rhinitis is because the nasal cavity tissue is the door of respiratory tract outermost, be subjected to the invasion and attack of various paathogenic factors easily, according to statistics, in the patient of all upper respiratory tract infection, rhinitis symptom is in various degree just arranged more than 90%.Rhinitis type complexity, the state of an illness is long, the state of an illness is heavy, and is commonly encountered diseases, and the obstinate easily recurrence of symptom is difficult to cure.Flu is a common disease all over the world, there is 75% people all can suffer from once flu every year in China, and because the quickening of human lives's rhythm, human physique's downward trend, following flu may be with more common, because the acute rhinitis and the close association of catching a cold, can estimate that will there be growth trend in following chronic rhinitis patient colony, and also sickness rate height of other rhinitis, patient colony is many.But medicine is many based on the combination of Chinese and Western medicine on the market, and pharmaceutical dosage form is single.

Acute rhinitis (sinusitis) is the nasal sinusitis of the traditional Chinese medical science, and allergic rhinitis is a traditional Chinese medical science allergic rhinitis, is nasal obstruction, watery nasal discharge, for a long time and the difficult disease that heals." Diagnostics of Chinese Medicine " thought: rhinorrhea and smelly person is a nasal sinusitis; The not smelly person of snivel is an allergic rhinitis.The official of nose person lung, lung is had one's ideas straightened out as nose, lung-QI connecting with the nose, lung and then nose can know good and foul smells.Five gas are gone into nose, are hidden in cardiopulmonary, and cardiopulmonary are ill, and nose is unfavorable.Chinese medicine is paid attention to endogenous cause of ill, the i.e. resistance against diseases of body self.Healthy energy is vigorous, both can avoid the exopathogen invasion, can make body that the pathological change of imbalance of YIN and YANG does not take place again." healthy energy internal memory, heresy can not be done ".Mostly the cause of disease of primary disease is the wind and cold heresy, and the character of disease belongs to and emptyly belongs to coldly, and sick position is dirty at lung, spleen, kidney three.It is marked on lung, its this genus kidney.Lung, spleen, kidney three dirty functions perfect, and healthy energy and vigour are just vigorous, and body's immunity is normal, and adopt the method for transferring spleen reinforcing, lung, kidney.When lung, spleen, kidney three dirty functional disorders, immunologic hypofunction then, and adopt the method for transferring spleen reinforcing, lung, kidney, and can improve immunologic function, improve immune status.And nasal sinusitis and allergic rhinitis mainly are because of insufficiency of lung-QI, striae of the skin and muscles being loose, and instability of surface, the heresy of wind and cold is taken advantage of a weak point, and the cold-evil stagnates, and body fluid is stopped at due to the nose key.

At above-mentioned pathogenesis, the traditional Chinese medical science mainly adopts the temperature compensation method, function of spleen and stomach regulating method, temperature male wind-supplying kidney method etc.Normal use warm based on sweet suffering, return through with lung, spleen two through topping the list, function is with dispelling wind and ventilating the lung, promoting diuresis to eliminate damp pathogen, invigorating the spleen and replenishing QI be that the drug matching of elder generation is treated.

Summary of the invention: for reaching the purpose of prevention, alleviation, healing rhinitis, the invention provides a kind of special effect that has, the drug regimen prescription that side effect is little, can treat above-mentioned coryza (being commonly called as the nose peace relaxes) and preparation technology and purposes, we are former in the folk remedy of Yi nationality, distributed over Yunnan, Sichuan and Guizhou compact community, above-mentioned disease had better curative effect, no toxicity.

To achieve these goals, the invention provides following technical scheme: drug regimen prescription essence contains the Radix Astragali, Radix Scutellariae, Herba Asari, Rhizoma Cimicifugae, DAZHUIFENG, Herba Inulae cappae, and surplus is the medicine adjuvant.Each constituent and composition scope thereof are in this pharmaceutical preparation: Radix Astragali 0.1-99.9%, Radix Scutellariae 0.1-99.9%, Herba Asari 0.1-99.9%, Rhizoma Cimicifugae 0.1-99.9%, DAZHUIFENG 0.1-99.9%, Herba Inulae cappae 0.1-99.9%, medicine adjuvant 99.9%-0.1%.

Each constituent and composition essence thereof contain medical material in this pharmaceutical preparation: Radix Astragali 10-20%, and Radix Scutellariae 10-20%, Herba Asari 2-5%, Rhizoma Cimicifugae 3-9%, DAZHUIFENG 20-30%, Herba Inulae cappae 30-40%, surplus is the medicine adjuvant.

Each constituent and composition essence thereof contain the best ratio range of medical material in this pharmaceutical preparation: Radix Astragali 12.83%-15.46%; Radix Scutellariae 12.83%-15.46%; Herba Asari 2.3%-2.63%; Rhizoma Cimicifugae 5.3%-6.36%; DAZHUIFENG 24%-29.33%; Herba Inulae cappae 33.33%-40%; Surplus is the medicine adjuvant.The Radix Astragali: 106.25 ± 10g then, Radix Scutellariae: 106.25 ± 10g, Herba Asari: 18.75 ± 1g, Rhizoma Cimicifugae: 43.75 ± 4g, DAZHUIFENG: 200 ± 20g, Herba Inulae cappae: 275 ± 25g.

Being used for the treatment of in the drug regimen of coryza each constituent and best proportioning components thereof is: the best proportioning that every 100g extract (fluid extract or dry extract) contains medical material is: the Radix Astragali: 106.25 grams, Radix Scutellariae: 106.25 grams, Herba Asari: 18.75 grams, Rhizoma Cimicifugae: 43.75 grams, DAZHUIFENG: 200 grams, Herba Inulae cappae: 275 grams, then amount to 750 grams, through obtaining 100 gram extractum or dry extracts (active ingredient) after the extraction process by above-mentioned six kinds of medical materials.

The Radix Astragali: Astragalus membranaceus (Fisch.) Bge.var.mongholicus (Bge.) Hsiao or Asrragalusmembranaceus (Fisch.) Bge, for the Radix Astragali in the prescription of the dry root invention medicine of leguminous plant Radix Astagali or Radix Astragali is the leguminous plant Radix Astragali, sweet in the mouth is warm in nature, return the spleen lung meridian, invigorating QI to consolidate the body surface resistance is arranged, merits such as granulation promoting evacuation of pus, " medicine origin " cloud: " control deficient spontaneous perspiration, tonifying the lung gas; real fur, eliminating the pathogens from the lung moderate heat, the stringy pulse spontaneous perspiration; The kind weakness of the spleen and stomach of controlling, the cloudy disease skin infection of expelling the toxic substance from the body with tonic must medication." be used for replenishing and restoring lung-QI and be monarch drug.

Herba Asari: Astragam heterotropoides Fr.Schmidt var.mandshuricum (maxim.) kitag; AsarumSieboldii Miq.var.seoulense or Asarum Sieboldii miq. are the aristolochiaceae plant Herba Asari, the dry herb of Seoul Herba Asari or magnificent Herba Asari.Herba Asari is the aristolochiaceae plant Herba Asari, and acrid in the mouth is warm in nature, returns the lung kidney channel, delivers cold expelling, the merit of wind-expelling pain-stopping, " China book on Chinese herbal medicine ": " cold expelling dispels the wind, pain relieving, warming the lung, reduce phlegm, sensible.Cure mainly wind and cold table disease, headache, toothache, rheumatic arthralgia, phlegm retention are breathed with cough, nasal obstruction, nasal sinusitis, aphtha ".

Herba Inulae cappae: Inula cappa DC. is the dry herb of feverfew Herba Inulae cappae.Another name: Herba Inulae cappae, Aries ear, Bai Yeju, sheep rumor.Herba Inulae cappae is the herb of feverfew Herba Inulae cappae, acrid in the mouth, sweet, little hardship, warm in nature, return lung meridian, expelling wind and cold is arranged, the circulation of qi promoting dampness removing, the effect of removing toxic substances and promoting subsidence of swelling, " China book on Chinese herbal medicine ": " expelling wind and cold, circulation of qi promoting dampness removing, removing toxic substances and promoting subsidence of swelling, curing mainly anemofrigid cold, cough ... " two medicines share the cold expelling with Da Xinwen, sensible merit.

Rhizoma Cimicifugae: Cimicifuga foetidaL. is the dry rhizome of cohosh Rhizoma Cimicifugae.Rhizoma Cimicifugae is the root of cohosh Rhizoma Cimicifugae, acrid in the mouth, little hardship, is slightly cold, and returns lung splenomegaly the intestines and stomach warp, delivers the treatment heat-clearing and toxic substances removing, and the merit of elevate a turnable ladder yang-energy can help the above three lung benefiting gas of building up one's health by taking tonic, and cold expelling is sensible to be ministerial drug altogether.

DAZHUIFENG: Leycesteria formosa Wall. is the dry herb of caprifoliaceae plant Folium Mume bamboo.Another name: hollow wood, Herba Leycesteriae formosae, Herba Leycesteriae stenosepalae, wild reed stems.DAZHUIFENG is blown desolate stem and leaf for the caprifoliaceae plant ghost, " medical magazine ": " heat-clearing and toxic substances removing, blood circulation promoting and blood stasis dispelling ", " Yunnan Chinese herbal medicine ": " dampness removing, invigorate blood circulation, antiinflammatory ".

Radix Scutellariae: Scutelleria baicalensis Georgi is the dry root of labiate Radix Scutellariae.Radix Scutellariae is the root of labiate Radix Scutellariae, and bitter in the mouth, cold in nature is returned the lung large intestine channel, and the merit of heat clearing and damp drying eliminating fire and detoxication is arranged, and two is product cold in nature, can detoxify to be assistant.Above Six-element share plays benefiting QI for strengthening the superficies altogether, the merit of expelling pathogenic wind and restoring the functions of orifices in face, and available rhinocnesmus, sneeze, thin nasal discharge, the nasal obstruction of controlling the allergic rhinitis performance also can be used for diseases such as nasal sinusitis watery nasal discharge.

Preparation and preparation method that the present invention is used for the treatment of the easypro medicine of nose peace of coryza are:

Essence contains Radix Astragali 0.1-99.9% in the preparation, Radix Scutellariae 0.1-99.9%, and Herba Asari 0.1-99.9%, Rhizoma Cimicifugae 0.1-99.9%, DAZHUIFENG 0.1-99.9%, Herba Inulae cappae 0.1-99.9%, all the other are the medicine adjuvant.Said preparation is: granule, hard capsule, enteric coated capsule, microcapsule, tablet, Film coated tablets, enteric coated tablet, drop pill, soft capsule, mixture (oral liquid), nasal drop.

The easypro drug regimen fluid extract of nose peace and the dry extract extracting method of treatment coryza are as follows:

(1) Radix Astragali, Radix Scutellariae, Herba Asari, Rhizoma Cimicifugae, DAZHUIFENG, Herba Inulae cappae Six-element pharmaceutical decocting piece are cleaned, the water logging bubble that adding 9-12 doubly measures 2-4 hour is supplied the water yield by water absorption rate before decocting, and decocts 1-2 hour for the first time;

(2) for the second time, the decocting that respectively adds 6 times of amounts for the third time boiled 0.5-1 hour, filter, merge three times filtrate, being concentrated into relative density is 1.05-1.10, by 0.4% adding pretreating agent B, behind 50 ℃ of insulation 4h, boil the 15-30min enzyme denaturing, be cooled to 50 ℃, add medicinal clarifier (ZTC-II type or ZTC-III type) component, mixing by 4-8%, be warming up to 70 ℃ again, press 2-4% and add pretreating agent B component, stir evenly, behind the adding clarifier (ZTC-II type or ZTC-III type), heat to about 80 ℃ 30 minutes, when treating that temperature is reduced to 50 ℃, add Pulvis Talci, be incubated 30 minutes by 0.5% of amount of liquid medicine;

(3) standing over night is drawn supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

Be used for the treatment of the fluid extract and the dry extract preparation method of coryza, it is characterized in that:

(1) Radix Astragali, Radix Scutellariae, Herba Asari, Rhizoma Cimicifugae, DAZHUIFENG, Herba Inulae cappae Six-element pharmaceutical decocting piece are cleaned, the water logging bubble that adding 9-12 doubly measures 2-4 hour is supplied the water yield by water absorption rate before decocting, and decocts 1-2 hour for the first time;

(2) second and third time decocting of respectively adding 6 times of amounts boiled 0.5-1 hour, filtered, and merged three times filtrate, and being concentrated into relative density is 1.18-1.26, and adding 2-5 doubly measures 95% ethanol, stirs evenly;

(3) leave standstill more than 24 hours, draw supernatant liquid filtering, filtrate decompression concentrate fluid extract, dry dry extract.

The described nose that is used for the treatment of coryza is pacified in the drug regimen that relaxes can add medicinal pretreating agent, clarifier, excipient, solvent, antiseptic, correctives, PH regulator, isoosmotic adjusting agent.

Pretreating agent: pretreating agent B (being called for short the ZTC-pretreating agent), production unit: Beijing became the clarification technique company limited in positive day;

Medicinal clarifier: ZTC-II (ZTC1+1 natural clarifying agent, production unit: Beijing became the clarification technique company limited in positive day), ZTC-III (ZTC1+1 natural clarifying agent, production unit: Beijing became the clarification technique company limited in positive day), ethanol;

Excipient: gelatin, glycerol, dextrin, starch, silicon dioxide, magnesium stearate, microcrystalline Cellulose, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, active carbon, Cera Flava, Polyethylene Glycol, polyvinylpyrrolidone, tween 80.

Solvent: vegetable oil (Oleum Arachidis hypogaeae semen, Oleum Brassicae campestris, walnut oil), glycerol, propylene glycol, liquid paraffin, Cera Flava; Purified water.

Antiseptic: benzoic acid and sodium benzoate, methyl parahydroxybenzoate, ethyl ester, propyl ester, butyl ester (parabens).

Correctives: Mel, stevioside, saccharin sodium.

PH regulator: hydrochloric acid, acetic acid, citric acid, sodium hydrogen phosphate, sodium dihydrogen phosphate.

Isoosmotic adjusting agent: sodium chloride, glucose.

More than the quantity of the clarifier of Tian Jiaing, excipient, solvent, antiseptic, correctives, PH regulator, isoosmotic adjusting agent is undertaken by the medicinal standard requirement.

The preparation technology who is used for the treatment of the medicine composition of coryza:

The described preparation method that is used for the treatment of (the nose peace is relaxed) granule of rhinitis is: the medicine dry extract is pulverized, crossed the 80-100 sieve, with auxiliary materials and mixing such as starch, dextrin, stevioside, granulation, drying, granulate, packing are promptly; Describedly be used for the treatment of (nose peace relax) medicine capsule of rhinitis or the preparation method of enteric coated capsule is: the medicine dry extract is pulverized, cross the 80-100 sieve, with silicon dioxide, magnesium stearate, microcrystalline Cellulose, ethyl cellulose mixing, granulation, granulate, be packed in hard capsule or the enteric coated capsule promptly.The described preparation method that is used for the treatment of (the nose peace is relaxed) microcapsule of rhinitis is: the medicine dry extract is pulverized, cross 200 mesh sieves, with hydroxypropyl cellulose granulation, dry, granulate, the capsule grain is placed in the coating machine, the alcoholic solution that adds Polyethylene Glycol and ethyl cellulose is made microcapsule, be packed into hard capsule or compacting in flakes, promptly.

The described preparation method that is used for the treatment of (the nose peace is relaxed) tablet of rhinitis is: each supplementary material weighing of the consumption of will filling a prescription, mixing, granulation, drying, tabletting are promptly; Describedly be used for the treatment of (nose peace relax) Film coated tablets of rhinitis or the preparation method of enteric coated tablet is: the medicine dry extract is pulverized, cross 80 mesh sieves, with starch, microcrystalline Cellulose, magnesium stearate mixing, granulation, drying, compacting in flakes, bag film-coat or enteric coating promptly.

Described (the nose peace is relaxed) preparation of soft capsule method that is used for the treatment of rhinitis is: the medicine dry extract is pulverized, crossed 200 mesh sieves, with auxiliary materials and mixing such as Polyethylene Glycol, gelatin, glycerol, water, make soft capsule promptly; The described preparation method that is used for the treatment of (the nose peace is relaxed) drop pill of rhinitis is: the medicine dry extract is pulverized, crossed 200 mesh sieves, with auxiliary materials and mixing such as Polyethylene Glycol, glycerol, make drop pill promptly.

The described preparation technology who is used for the treatment of (the nose peace is relaxed) mixture (oral liquid) of rhinitis is: the easypro fluid extract of nose peace is added purified water, heating for dissolving, adding Mel, active carbon boil, filtered while hot, cold preservation, filtration, filtrate adds citric acid, add purified water and be adjusted to amount of preparation, packing, sterilization, promptly.

The described preparation technology who is used for the treatment of (the nose peace is relaxed) nasal drop of rhinitis is: the easypro fluid extract of nose peace is added purified water, heating for dissolving, add active carbon, boil, filter, filtrate cold preservation, draw supernatant liquid filtering, filtrate adding sodium chloride adjusting etc. is oozed, and adds sodium dihydrogen phosphate and sodium hydrogen phosphate to regulate pH value, adds ethyl hydroxybenzoate, add purified water again and be adjusted to amount of preparation, packing, promptly.

The purposes that is used for the treatment of (the nose peace is relaxed) drug regimen of rhinitis: this drug regimen special character is to be used for the treatment of acute rhinitis (traditional Chinese medical science belongs to wind card category), chronic rhinitis (traditional Chinese medical science belongs to the stuffy nose category), atrophic rhinitis's (traditional Chinese medical science belongs to the atrophic rhinitis category), caseous rhinitis (traditional Chinese medical science belongs to the nasal sinusitis category), acute and chronic nasal sinusitis and purulent sinusitis's (traditional Chinese medical science belongs to the nasal sinusitis category), allergic rhinitis or allergic rhinitis rhinitis class diseases such as (traditional Chinese medical science belong to the allergic rhinitis category).

The present invention treats that the drug regimen prescription (be commonly called as nose peace relax) of coryza is former to have special effect in the folk remedy of Yi nationality, distributed over Yunnan, Sichuan and Guizhou compact community, and side effect is little, and no toxicity can prevent, alleviate, cures rhinitis, has better curative effect.

Specific embodiments:

Further specify essence of the present invention below in conjunction with example, but they not limitations of the present invention.

The preparation of embodiment 1 (the nose peace is relaxed) fluid extract and dry extract

Take by weighing Radix Astragali 116.25kg, Radix Scutellariae 116.25kg, Rhizoma Cimicifugae 47.75kg, Herba Asari 19.75kg, DAZHUIFENG 220kg, Herba Inulae cappae 220kg, the Six-element pharmaceutical decocting piece is 770kg altogether, cleans, cleans.The water logging that adds 9 times of amounts was steeped 2 hours, supplied the water yield by water absorption rate before decocting, and decocted 1.5 hours for the first time, and the decocting that second and third time respectively adds 6 times of amounts boiled 1 hour, filtered, and merged three times filtrate, and being concentrated into relative density is 1.05.When fluid temperature is 80 ℃, under constantly stirring, add ZTC1+III type clarifier B component by amount of liquid medicine 6% slowly, stir evenly, when treating that fluid temperature is reduced to 50 ℃, add ZTC1+III type clarifier A component with method by amount of liquid medicine 3%, stir evenly, add Pulvis Talci by 0.5% of amount of liquid medicine, 50 ℃ are incubated 1 hour, left standstill 12 hours.Draw supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

Take by weighing Radix Astragali 116.25kg, Radix Scutellariae 116.25kg, Rhizoma Cimicifugae 47.75kg, Herba Asari 19.75kg, DAZHUIFENG 220kg, Herba Inulae cappae 220kg, the Six-element pharmaceutical decocting piece is 770kg altogether, cleans, cleans.The water logging that adds 12 times of amounts was steeped 4 hours, supply the water yield by water absorption rate before decocting, decocted second 2 hours for the first time, the decocting that respectively adds 6 times of amounts for three times boiled 0.5 hour, filter, merge three times filtrate, being concentrated into relative density is 1.10, when fluid temperature is 80 ℃, under constantly stirring, add ZTC1+1III type clarifier B component by amount of liquid medicine 10% slowly, stir evenly, when treating that fluid temperature is reduced to 50 ℃, add the A component by amount of liquid medicine 5% with method, stir evenly, add Pulvis Talci by 0.5% of amount of liquid medicine, 50 ℃ are incubated 2 hours, leave standstill more than 8 hours, draw supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

Embodiment 2 (the nose peace is relaxed) fluid extract and dry extract preparation

Take by weighing Radix Astragali 96.25kg, Radix Scutellariae 96.25kg, Rhizoma Cimicifugae 39.75kg, Herba Asari 17.75kg, DAZHUIFENG 180kg, Herba Inulae cappae 220kg, the Six-element pharmaceutical decocting piece is 650kg altogether, cleans, cleans.The water logging that adds 9 times of amounts was steeped 2 hours, supplied the water yield by water absorption rate before decocting, and decocted 1.5 hours for the first time, and the decocting that second and third time respectively adds 6 times of amounts boiled 1 hour, filtered, and merged three times filtrate, and being concentrated into relative density is 1.05.By 0.4% adding pretreating agent B, behind 50 ℃ of insulation 4h, boil the 15min enzyme denaturing, be cooled to 50 ℃, add ZTC-II type natural clarifying agent A component, mixing by 8%, be warming up to 70 ℃ again, by 4% adding pretreating agent B component, stir evenly, behind the adding clarifier, heat to about 80 ℃ 30 minutes, when treating that temperature is reduced to 50 ℃, add Pulvis Talci, be incubated 30 minutes by 0.5% of amount of liquid medicine.Standing over night is drawn supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

Take by weighing Radix Astragali 96.25kg, Radix Scutellariae 96.25kg, Rhizoma Cimicifugae 39.75kg, Herba Asari 17.75kg, DAZHUIFENG 180kg, Herba Inulae cappae 220kg, the Six-element pharmaceutical decocting piece is 650kg altogether, cleans, cleans.The water logging that adds 12 times of amounts was steeped 4 hours, supplied the water yield by water absorption rate before decocting, and decocted 2 hours for the first time, and the decocting that second and third time respectively adds 6 times of amounts boiled 0.5 hour, filtered, and merged three times filtrate, and being concentrated into relative density is 1.10.By 0.4% adding pretreating agent B, behind 50 ℃ of insulation 6h, boil the 30min enzyme denaturing, be cooled to 50 ℃, add ZTC-II type natural clarifying agent A component, mixing by 4%, be warming up to 70 ℃ again, by 2% adding pretreating agent B component, stir evenly, behind the adding clarifier, heat to about 80 ℃ 30 minutes, when treating that temperature is reduced to 50 ℃, add Pulvis Talci, be incubated 30 minutes by 0.5% of amount of liquid medicine.Standing over night is drawn supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

Embodiment 3 (the nose peace is relaxed) fluid extract and dry extract preparation

Take by weighing the Radix Astragali: 106.25kg, Radix Scutellariae: 106.25kg, Herba Asari: 18.75kg, Rhizoma Cimicifugae: 43.75kg, DAZHUIFENG: 200kg, Herba Inulae cappae: 275kg, the Six-element pharmaceutical decocting piece is 750kg altogether, clean, clean, the water logging that adds 9 times of amounts was steeped 2 hours, supply the water yield by water absorption rate before decocting, for the first time decocted second 1.5 hours, the decocting that respectively adds 6 times of amounts for three times boiled 1 hour, filtered, merge three times filtrate, being concentrated into relative density is 1.18, adds 5 times of amount 95% ethanol, stirs evenly, leave standstill more than 24 hours, draw supernatant liquid filtering, filtrate decompression concentrate fluid extract, dry dry extract.

Take by weighing the Radix Astragali: 106.25kg, Radix Scutellariae: 106.25kg, Herba Asari: 18.75kg, Rhizoma Cimicifugae: 43.75kg, DAZHUIFENG: 200kg, Herba Inulae cappae: 275kg, the Six-element pharmaceutical decocting piece is 750kg altogether, cleans, cleans.The water logging that adds 10 times of amounts was steeped 2 hours, supplied the water yield by water absorption rate before decocting, and decocted 2 hours for the first time, the decocting that second and third time respectively adds 6 times of amounts boiled 0.5 hour, filter, merge three times filtrate, being concentrated into relative density is 1.26, add 2 times of amount 95% ethanol, stir evenly, leave standstill more than 24 hours, draw supernatant liquid filtering, filtrate decompression concentrate fluid extract, dry dry extract.

The preparation of embodiment 4 (the nose peace is relaxed) fluid extract and dry extract

Take by weighing Radix Astragali 3.06kg, Radix Scutellariae 3.06kg, Rhizoma Cimicifugae 1.36kg, Herba Asari 0.58kg, DAZHUIFENG 5.12kg, Herba Inulae cappae 6.17kg Six-element pharmaceutical decocting piece 19.35kg altogether, clean, the water logging that adds 9 times of amounts was steeped 2 hours, supply the water yield by water absorption rate before decocting, decocted 1.5 hours for the first time, the decocting that second and third time respectively adds 6 times of amounts boiled 1 hour, filtered, merge three times filtrate, being concentrated into relative density is 1.05.When fluid temperature is 80 ℃, under constantly stirring, add ZTC1+1III type clarifier B component by amount of liquid medicine 6% slowly, stir evenly, when treating that fluid temperature is reduced to 50 ℃, add the A component with method by amount of liquid medicine 3%, stir evenly, add Pulvis Talci by 0.5% of amount of liquid medicine, 50 ℃ are incubated 1 hour, left standstill 12 hours.Draw supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

Take by weighing Radix Astragali 4.1kg, Radix Scutellariae 4.1kg, Rhizoma Cimicifugae 1.53kg, Herba Asari 0.69kg, DAZHUIFENG 7.76kg, Herba Inulae cappae 12.32 Six-element pharmaceutical decocting pieces are 30.5kg altogether, clean, the water logging that adds 12 times of amounts was steeped 4 hours, supply the water yield by water absorption rate before decocting, decocted second 2 hours for the first time, the decocting that respectively adds 6 times of amounts for three times boiled 0.5 hour, filter, merge three times filtrate, being concentrated into relative density is 1.10, when fluid temperature is 80 ℃, under constantly stirring, add ZTC1+1III type clarifier B component by amount of liquid medicine 10% slowly, stir evenly, when treating that fluid temperature is reduced to 50 ℃, add the A component by amount of liquid medicine 5% with method, stir evenly, add Pulvis Talci by 0.5% of amount of liquid medicine, 50 ℃ are incubated 2 hours, leave standstill more than 8 hours, draw supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

Embodiment 5 (the nose peace is relaxed) fluid extract and dry extract preparation

Take by weighing Radix Astragali 4.1kg, Radix Scutellariae 4.1kg, Rhizoma Cimicifugae 1.53kg, Herba Asari 0.69kg, DAZHUIFENG 7.76kg, Herba Inulae cappae 12.32 Six-element pharmaceutical decocting pieces 30.5kg altogether, clean, the water logging that adds 9 times of amounts was steeped 2 hours, supply the water yield by water absorption rate before decocting, decocted 1.5 hours for the first time, the decocting that second and third time respectively adds 6 times of amounts boiled 1 hour, filtered, merge three times filtrate, being concentrated into relative density is 1.05.By 0.4% adding pretreating agent B, behind 50 ℃ of insulation 4h, boil the 15min enzyme denaturing, be cooled to 50 ℃, add ZTC-II type natural clarifying agent A component, mixing by 8%, be warming up to 70 ℃ again, by 4% adding B component, stir evenly, behind the adding clarifier, heat to about 80 ℃ 30 minutes, when treating that temperature is reduced to 50 ℃, add Pulvis Talci, be incubated 30 minutes by 0.5% of amount of liquid medicine.Standing over night is drawn supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

Take by weighing Radix Astragali 3.06kg, Radix Scutellariae 3.06kg, Rhizoma Cimicifugae 1.36kg, Herba Asari 0.58kg, DAZHUIFENG 5.12kg, Herba Inulae cappae 6.17kg Six-element pharmaceutical decocting piece 19.35kg altogether, clean, the water logging that adds 12 times of amounts was steeped 4 hours, supply the water yield by water absorption rate before decocting, decocted 2 hours for the first time, the decocting that second and third time respectively adds 6 times of amounts boiled 0.5 hour, filtered, merge three times filtrate, being concentrated into relative density is 1.10.By 0.4% adding pretreating agent B, behind 50 ℃ of insulation 6h, boil the 30min enzyme denaturing, be cooled to 50 ℃, add ZTC-II type natural clarifying agent A component, mixing by 4%, be warming up to 70 ℃ again, by 2% adding B component, stir evenly, behind the adding clarifier, heat to about 80 ℃ 30 minutes, when treating that temperature is reduced to 50 ℃, add Pulvis Talci, be incubated 30 minutes by 0.5% of amount of liquid medicine.Standing over night is drawn supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

Embodiment 6 (the nose peace is relaxed) fluid extract and dry extract preparation

Take by weighing Radix Astragali 3.06kg, Radix Scutellariae 3.06kg, Rhizoma Cimicifugae 1.36kg, Herba Asari 0.58kg, DAZHUIFENG 5.12kg, Herba Inulae cappae 6.17kg Six-element pharmaceutical decocting piece 19.35kg altogether, clean, the water logging that adds 9 times of amounts was steeped 2 hours, supply the water yield by water absorption rate before decocting, decocted 1.5 hours for the first time, the decocting that second and third time respectively adds 6 times of amounts boiled 1 hour, filtered, merge three times filtrate, being concentrated into relative density is 1.18, adds 5 times of amount 95% ethanol, stirs evenly, leave standstill more than 24 hours, draw supernatant liquid filtering, filtrate decompression concentrate fluid extract, dry dry extract.

Take by weighing Radix Astragali 4.1kg, Radix Scutellariae 4.1kg, Rhizoma Cimicifugae 1.53kg, Herba Asari 0.69kg, DAZHUIFENG 7.76kg, Herba Inulae cappae 12.32 Six-element pharmaceutical decocting pieces 30.5kg altogether, clean, the water logging that adds 12 times of amounts was steeped 4 hours, supply the water yield by water absorption rate before decocting, decocted 2 hours for the first time, the decocting that second and third time respectively adds 6 times of amounts boiled 0.5 hour, filter, merge three times filtrate, being concentrated into relative density is 1.26, add 2 times of amount 95% ethanol, stir evenly, leave standstill more than 24 hours, draw supernatant liquid filtering, filtrate decompression concentrate fluid extract, dry dry extract.

The preparation of embodiment 7 (the nose peace is relaxed) fluid extract and dry extract

Press Radix Astragali 10-20%, Radix Scutellariae 10-20%, Herba Asari 2-5%, Rhizoma Cimicifugae 3-9%, DAZHUIFENG 20-30%, Herba Inulae cappae 30-40% ratio takes by weighing totally 24 kilograms of the Radixs Astragali, Radix Scutellariae, Rhizoma Cimicifugae, Herba Asari, DAZHUIFENG, Herba Inulae cappae Six-element pharmaceutical decocting piece, cleans.The water logging that adds 9 times of amounts was steeped 2 hours, supplied the water yield by water absorption rate before decocting, and decocted 1.5 hours for the first time, and the decocting that second and third time respectively adds 6 times of amounts boiled 1 hour, filtered, and merged three times filtrate, and being concentrated into relative density is 1.05.When fluid temperature is 80 ℃, under constantly stirring, add ZTC1+1III type clarifier B component by amount of liquid medicine 6% slowly, stir evenly, when treating that fluid temperature is reduced to 50 ℃, add the A component with method by amount of liquid medicine 3%, stir evenly, add Pulvis Talci by 0.5% of amount of liquid medicine, 50 ℃ are incubated 1 hour, left standstill 12 hours.Draw supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

Press Radix Astragali 10-20%, Radix Scutellariae 10-20%, Herba Asari 2-5%, Rhizoma Cimicifugae 3-9%, DAZHUIFENG 20-30%, Herba Inulae cappae 30-40% ratio takes by weighing totally 24 kilograms of the Radixs Astragali, Radix Scutellariae, Rhizoma Cimicifugae, Herba Asari, DAZHUIFENG, Herba Inulae cappae Six-element pharmaceutical decocting piece, cleans.The water logging that adds 12 times of amounts was steeped 4 hours, supply the water yield by water absorption rate before decocting, decocted second 2 hours for the first time, the decocting that respectively adds 6 times of amounts for three times boiled 0.5 hour, filter, merge three times filtrate, being concentrated into relative density is 1.10, when fluid temperature is 80 ℃, under constantly stirring, go into ZTC1+1III type clarifier B component by amount of liquid medicine 10% slowly, stir evenly, when treating that fluid temperature is reduced to 50 ℃, add the A component by amount of liquid medicine 5% with method, stir evenly, add Pulvis Talci by 0.5% of amount of liquid medicine, 50 ℃ are incubated 2 hours, leave standstill more than 8 hours, draw supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

Embodiment 8 (the nose peace is relaxed) fluid extract and dry extract preparation

Press Radix Astragali 10-20%, Radix Scutellariae 10-20%, Herba Asari 2-5%, Rhizoma Cimicifugae 3-9%, DAZHUIFENG 20-30%, Herba Inulae cappae 30-40% ratio takes by weighing totally 24 kilograms of the Radixs Astragali, Radix Scutellariae, Rhizoma Cimicifugae, Herba Asari, DAZHUIFENG, Herba Inulae cappae Six-element pharmaceutical decocting piece, cleans.The water logging that adds 9 times of amounts was steeped 2 hours, supplied the water yield by water absorption rate before decocting, and decocted 1.5 hours for the first time, and the decocting that second and third time respectively adds 6 times of amounts boiled 1 hour, filtered, and merged three times filtrate, and being concentrated into relative density is 1.05.By 0.4% adding pretreating agent B, behind 50 ℃ of insulation 4h, boil the 15min enzyme denaturing, be cooled to 50 ℃, add ZTC-II type natural clarifying agent A component, mixing by 8%, be warming up to 70 ℃ again, by 4% adding B component, stir evenly, behind the adding clarifier, heat to about 80 ℃ 30 minutes, when treating that temperature is reduced to 50 ℃, add Pulvis Talci, be incubated 30 minutes by 0.5% of amount of liquid medicine.Standing over night is drawn supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

Press Radix Astragali 10-20%, Radix Scutellariae 10-20%, Herba Asari 2-5%, Rhizoma Cimicifugae 3-9%, DAZHUIFENG 20-30%, Herba Inulae cappae 30-40% ratio takes by weighing totally 24 kilograms of the Radixs Astragali, Radix Scutellariae, Rhizoma Cimicifugae, Herba Asari, DAZHUIFENG, Herba Inulae cappae Six-element pharmaceutical decocting piece, cleans.The water logging that adds 12 times of amounts was steeped 4 hours, supplied the water yield by water absorption rate before decocting, and decocted 2 hours for the first time, and the decocting that second and third time respectively adds 6 times of amounts boiled 0.5 hour, filtered, and merged three times filtrate, and being concentrated into relative density is 1.10.By 0.4% adding pretreating agent B, behind 50 ℃ of insulation 6h, boil the 30min enzyme denaturing, be cooled to 50 ℃, add ZTC-II type natural clarifying agent A component, mixing by 4%, be warming up to 70 ℃ again, by 2% adding B component, stir evenly, behind the adding clarifier, heat to about 80 ℃ 30 minutes, when treating that temperature is reduced to 50 ℃, add Pulvis Talci, be incubated 30 minutes by 0.5% of amount of liquid medicine.Standing over night is drawn supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

Embodiment 9 (the nose peace is relaxed) fluid extract and dry extract preparation

Press Radix Astragali 10-20%, Radix Scutellariae 10-20%, Herba Asari 2-5%, Rhizoma Cimicifugae 3-9%, DAZHUIFENG 20-30%, Herba Inulae cappae 30-40% ratio takes by weighing the Radix Astragali, Radix Scutellariae, Rhizoma Cimicifugae, Herba Asari, DAZHUIFENG, totally 24 kilograms of Herba Inulae cappae Six-element pharmaceutical decocting pieces, clean, the water logging that adds 9 times of amounts was steeped 2 hours, supplied the water yield by water absorption rate before decocting, and decocted 1.5 hours for the first time, second, the decocting that respectively adds 6 times of amounts for three times boiled 1 hour, filter, merge three times filtrate, being concentrated into relative density is 1.18, add 5 times of amount 95% ethanol, stir evenly, leave standstill more than 24 hours, draw supernatant liquid filtering, filtrate decompression concentrate fluid extract, dry dry extract.

Press Radix Astragali 10-20%, Radix Scutellariae 10-20%, Herba Asari 2-5%, Rhizoma Cimicifugae 3-9%, DAZHUIFENG 20-30%, Herba Inulae cappae 30-40% ratio takes by weighing totally 24 kilograms of the Radixs Astragali, Radix Scutellariae, Rhizoma Cimicifugae, Herba Asari, DAZHUIFENG, Herba Inulae cappae Six-element pharmaceutical decocting piece, cleans.The water logging that adds 12 times of amounts was steeped 4 hours, supplied the water yield by water absorption rate before decocting, and decocted 2 hours for the first time, the decocting that second and third time respectively adds 6 times of amounts boiled 0.5 hour, filter, merge three times filtrate, being concentrated into relative density is 1.26, add 2 times of amount 95% ethanol, stir evenly, leave standstill more than 24 hours, draw supernatant liquid filtering, filtrate decompression concentrate fluid extract, dry dry extract.

The embodiment of embodiment 10 (the nose peace is relaxed) granule

	Component	Low dosage (g)	Optimal dose (g)	High dose (g)	Percentage ratio (%)	Specification
							Prescription	The easypro dry extract of nose peace	1	40	99	1-99	The 10g/ bag
Dextrin	98.9	59.9	0.9	98.9-0.9
					Stevioside	0.1		0.1	0.1	0.1
Method for making	Make granule, drying, granulate, packing after each supplementary material weighing, mixing with the prescription consumption, promptly.

The embodiment of embodiment 11 (the nose peace is relaxed) hard capsule

	Component	Low dosage (g)	Optimal dose (g)	High dose (g)	Percentage ratio (%)	Specification
							Prescription	The easypro dry extract of nose peace	1	40	99	1-99	0.4g/ grain
Silicon dioxide	98.75	59.75	0.75	98.75-0.75
					Magnesium stearate	0.25		0.25	0.25	0.25
Method for making	Make granule, drying, granulate, the hard capsule of packing into after each supplementary material weighing, mixing with the prescription consumption, promptly.

The embodiment of embodiment 12 (the nose peace is relaxed) enteric coated capsule

	Component	Low dosage (g)	Optimal dose (g)	High dose (g)	Percentage ratio (%)	Specification
							Prescription	The easypro dry extract of nose peace	1	40	99	1-99	0.4g/ grain
Silicon dioxide	98.75	59.75	0.75	98.75-0.75
					Magnesium stearate	0.25		0.25	0.25	0.25
Method for making	Make granule after each supplementary material weighing, mixing with the prescription consumption, be packed in the enteric hollow capsule, promptly respectively.

The embodiment of embodiment 13 (the nose peace is relaxed) microcapsule

	Component	Low dosage (g)	Optimal dose (g)	High agent (g)	Percentage ratio (%)	Specification
							Prescription	The easypro dry extract of nose peace	20	30	40	20-40	Every g contains principal agent 0.1g.
Hydroxypropyl cellulose	2	2	3	2-3
					Ethyl cellulose	1		1	2	1-2
Polyethylene Glycol	5	5	10	5-10
					Ethanol	In right amount		In right amount	In right amount	In right amount
Method for making	Take by weighing the easypro dry extract of nose peace (crossing 150 mesh sieves), hydroxypropyl cellulose system capsule grain with 3%, dry, granulate, the capsule grain is placed the coating machine, slowly spray into the alcoholic solution of ethyl cellulose and Polyethylene Glycol, make microcapsule, microcapsule inserted in the hard capsule or compacting in flakes, promptly.

The embodiment of embodiment 14 (the nose peace is relaxed) enteric coated tablet

	Component	Low dosage (g)	Optimal dose (g)	High dose (g)	Percentage ratio (%)	Specification
							Prescription	The easypro dry extract of nose peace	1	40	99	1-99	0.35g/ sheet
Microcrystalline Cellulose	98	59	0.75	98-0.75
					Magnesium stearate	1		1	0.25	1-0.25
Method for making	With each supplementary material weighing, mixing, granulation, drying, the tabletting of prescription consumption, that the plain sheet of making is promptly enteric coated respectively.

The embodiment of embodiment 15 (the nose peace is relaxed) drop pill

	Component	Low dosage (g)	Optimal dose (g)	High dose (g)	Percentage ratio (%)	Specification
							Prescription	The easypro dry extract of nose peace	1	40	80	1-80	Every 100mg
Polyethylene Glycol (6000)	99	60	20	99-20
					Method for making	Polyethylene Glycol is heated to 90-100 ℃, after treating all dissolvings, add the easypro dry extract of nose peace (crossing 200 mesh sieves) and be stirred to dissolving, airtight, and insulation is made drop pill by the drop pill machine, with the paraffin flush away of ethanol with the drop pill surface at 80-90 ℃, drying, polishing promptly.

The embodiment of embodiment 16 (the nose peace is relaxed) sheet

	Component	Low dosage (g)	Optimal dose (g)	High dose (g)	Percentage ratio (%)	Specification
							Prescription	The easypro dry extract of nose peace	1	40	99	1-99	0.3g/ sheet
Microcrystalline Cellulose	98	59	0.75	98-0.75
					Magnesium stearate	1		1	0.25	1-0.25
Method for making	With each supplementary material weighing, mixing, granulation, drying, tabletting of prescription consumption promptly.

The embodiment of embodiment 18 (the nose peace is relaxed) soft capsule

	Component	Low dosage (g)	Optimal dose (g)	High dose (g)	Percentage ratio (%)	Specification
							Prescription	The easypro dry extract of nose peace	1	20	40	1-40	0.2/ grain
Cera Flava	0.4	0.6	0.8	0.4-0.8
					Walnut oil	98.6		79.4	59.2	98.6-59.2
Method for making	(1) preparation of medicinal liquid: with walnut oil, Cera Flava heating mix homogeneously, 60 ℃ of insulations, with dry extract fine powder (crossing 200 mesh sieves), add in the above-mentioned oil solution, stir, cross colloidal grinding, make the pharmaceutical liquid of soft capsule, 50 ℃ of insulations are standby.(2) colloidal preparation: gelatin 100g, glycerol 30g, purified water 130g, ethyl hydroxybenzoate 1.5g are added in the glue pot, heat 70 ℃, stirred 30 minutes, 50 ℃ of insulations are standby.(3) medicinal liquid and glue are made soft gelatin capsule by pellet press, typing is dry, clean with ethanol, and drying, polishing is promptly.

The embodiment of embodiment 20 (the nose peace is relaxed) nasal drop

	Component	Low dosage	Optimal dose	High dose	Percentage ratio (%)	Specification
							Prescription	The easypro fluid extract of nose peace	1g	20g	40g	1-40	10ml/ props up
Sodium chloride	0.7g	0.7g	0.7g	0.7
					Ethyl hydroxybenzoate	0.3g		0.3g	0.3g	0.3
Sodium hydrogen phosphate and sodium dihydrogen phosphate	10g	10g	10g	10
					Purified water extremely	100ml		100ml	100ml	100ml
Method for making	Fluid extract is dissolved in the hot purified water, adding 0.5% active carbon boiled 30 minutes, filtered while hot, filtrate cold preservation 24 hours refilters, and filtrate adding sodium chloride adjusting etc. is oozed, regulate pH value to 5.5-7.5 with sodium hydrogen phosphate and sodium dihydrogen phosphate, add ethyl hydroxybenzoate, add purified water again to 100ml, packing promptly.

The embodiment of embodiment 19 (the nose peace is relaxed) mixture (oral liquid)

	Component	Low dosage	Optimal dose	High dose	Percentage ratio (%)	Specification
							Prescription	The easypro fluid extract of nose peace	1g	20g	40g	1-40	The 100ml/ bottle
Mel	30g	20g	12g	30-12
					Purified water extremely	100ml		100ml	100ml	100ml
Method for making	The easypro fluid extract of nose peace is dissolved in the purified water of heat, adding active carbon boiled 30 minutes, filtered while hot, filtrate cold preservation 24 hours, the absorption supernatant refilters, filtrate adds Mel, citric acid, adjust volume to 100ml, packing, sterilization promptly.

The embodiment of embodiment 17 (the nose peace is relaxed) Film coated tablets

	Component	Low dosage (g)	Optimal dose (g)	High dose (g)	Percentage ratio (%)	Specification
							Prescription	The easypro dry extract of nose peace	1	40	99	1-99	0.35g/ sheet
Microcrystalline Cellulose	98	59	0.75	98-0.75
					Magnesium stearate	1		1	0.25	1-0.25
Method for making	With each supplementary material weighing, mixing, granulation, drying, tabletting, bag film-coat of prescription consumption promptly.

The report of nose peace relieving capsule pharmacodynamics test

Functions such as summary: nose peace relieving capsule is the compound Chinese medicinal preparation of Yunnan Jinbi Pharmaceutical Co., Ltd.'s development, and tool sound heat-clearing and toxic substances removing, vegetables wind are sensible are mainly used in treatment acute and chronic rhinitis, sinusitis.This research is with the positive contrast medicine of TONGXIAO BIYAN PIAN, nose peace relieving capsule establish basic, normal, high 3 dosage groups (0.3,0.6,1.2gkg ^-1, be equivalent to 5,10 and 20 times of clinical recommended dose), establish blank (normal saline) simultaneously, observe antiinflammatory, the antibacterial and anti-allergic effects of nose peace relieving capsule.For its clinical practice provides the pharmacodynamics foundation.Knot is adopted and is shown: nose peace relieving capsule (0.3,0.6,1.2gkg ^-1. be equivalent to 5 of clinical recommendation tailoring, 10 and 20 times) dose dependent ground alleviates the mice caused by dimethylbenzene xylene auricle edema, its suppression ratio is respectively 39.8,51.6 and 62.1%: the nose of high dose peace relieving capsule can alleviate that capillary permeability increases due to the acetic acid: leukoplania and plasma protein ooze out in the test in rat air bag due to the carboxymethyl cellulose wadding sodium, the nose peace is relaxed wafer amount dependency ground, the chamber interior blood plasma egg of inhibition capsule from oozing out, effect is better than aspirin 0.2g/kg, but to not having obvious influence from the cell migration in the capsule, the trend that has the inflammation-inhibiting granuloma to form in addition. but effect is weaker than aspirin; Externally press down the mattress test and attack bright nose peace relieving capsule upper respiratory tract encountered pathogenic bacteria streptococcus pneumoniae, staphylococcus aureus, Jia Xingrongxuexinglianqiujun and distortion stalk bacterium are had certain inhibitory action, minimal inhibitory concentration be respectively 25.0,50.0,50.0 and 25.0mg/mL all be weaker than helium benzyl XiLin sodium injection; Nose peace relieving capsule and TONGXIAO BIYAN PIAN all can not antagonism 5-HT cause that this Mus stomach sill strip shrinks and histamine causes the reaction of guinea pig ileum smooth contraction: on the Cavia porcellus rhinitis model that the Fructus Capsici index rises, nose peace relieving capsule dose dependent ground suppresses Cavia porcellus and beats Suo and kneel and scratch the Mus reaction. and the inhibitory action Asia to the latter is obvious.Above results suggest nose peace relieving capsule has tangible antiinflammatory action, especially to the inflammation inflammatory swelling of acute stage, it is stronger to do the angle: the respiratory tract common pathogen is had certain inhibitory action, capsaicin is caused rhinitis the obvious suppression effect is also arranged: its drug effect is better than TONGXIAO BIYAN PIAN, is worth further further investigation.

Purpose:, provide nose peace relieving capsule to carry out antiinflammatory, antiallergic, pharmacodynamic study such as antibacterial to Yunnan Jinbi Pharmaceutical Co., Ltd. with the positive contrast medicine of TONGXIAO BIYAN PIAN. being used for the treatment of rhinitis for it is clinical provides experimental basis.

Test material

For reagent product and reagent

The quiet capsule of nose: provided by the Yunnan dark blue medicine medicine company limited of gold, specification 0.4g/ grain is equivalent to contain crude drug 6.0g, and each 3 of clinical recommendation consumption calculates by adult 60kg body weight every day 3 times, and clinical consumption is 0.06g/kg (being equivalent to crude drug amount 0.9g/kg).Face with preceding that to be mixed with variable concentrations with distilled water standby.Bacteriostatic test then is mixed with 500mg/ml with normal saline, and it is standby that solution is put 8 pounds of 30 minutes autoclavings.

TONGXIAO BIYAN PIAN: TONGXIAO BIYAN PIAN extractum, available from pharmaceutical factory of Yunnan University of Traditional Chinese Medicine, every g extractum is equivalent to crude drug in whole 3.51g, trimmed size: the 0.35g/ sheet is equivalent to crude drug 1.10g, consumption: oral, each 5～7, every day 3 times, calculate by adult 60kg body weight, clinical consumption is 0.105g/kg (being equivalent to the crude drug amount Q.33g/kg).Face with preceding that to be mixed with variable concentrations with distilled water standby.Bacteriostatic test then is mixed with 500mg/ml solution with normal saline, and to put 8 pounds of 30 minutes autoclavings standby.

Ampicillin sodium injection: specification: 1g/ bottle.Chinese medicine pharmacopeia 2000 editions is black defends the accurate word of medicine No. 101441, and HARBIN PHARMACEUTICAL GROUP CO., LTD. General Pharm. Factory is produced.It is standby for 10mg/ml to take by weighing 0.01g+1ml sterile saline dissolving back.

Nitrogen benzyl XiLin drug sensitive test paper (calling the scraps of paper in the following text): specification 10 μ g/ sheets, Beijing the Temple of Heaven medicine biotechnology development company.Matched group injection is produced by break medicine group pharmacy head factory with ampicillin, takes by weighing behind the 0.01g+1ml physiological saline solution standby for 10mg/ml.

Fumaric acid ketotifen sheet: specification 1mg/ sheet, No. the 344904th, the accurate word (1987) of Su Wei medicine, Yancheng pharmaceutical Co. Ltd produces.Face with preceding that to be mixed with variable concentrations with distilled water standby.

Nutrient agar, nutrient broth, the research of Shanghai, calf serum mountain biological product provide. and fresh sheep blood goes out unming Medical College experimental animal center to be provided.

All the other reagent are homemade analysis.

Experimental animal

Healthy ICR mice, SD rat and Cavia porcellus all go out unming Medical College's Experimental Animal Center provides (No. the 2001035th, the real moving card word in Yunnan, No. 2001034 .2002088 number.

Streptococcus pneumoniae (31001): Jia Xingrongxuexinglianqiujun (32205): staphylococcus aureus (26001); The distortion skewer fall (11002) provide by biological products assay institute strain center, Beijing. microorganism teaching and research room of unming Medical College preserves.

Instrument: CL-770 type clinical spectroscopic photometer and U135C type balance recorder are a day island proper Zhang company product.

Statistics credit folding: data are represented with mean ± standard deviation.The result adopts Student ' s, the check row statistical analysis.Method and result.

One, antiinflammatory action

Nose peace relieving capsule is to the influence of capillary permeability

50 of male ICR mouses, body weight 24.7 ± 3.0g.Be divided into 5 groups at random, 10 every group, promptly Ns matched group, nose are pacified basic, normal, high dosage group of relieving capsule and TONGXIAO BIYAN PIAN group.Irritate stomach respectively and give normal saline (NS), nose peace easypro glue Cuan 0.3,0.6,1.2gkg ^-1(be equivalent to clinical recommendation consumption 5,10,20 times) TONGXIAO BIYAN PIAN 3.8gkg ^-1, (be equivalent to clinical recommendation consumption 40 times), every day 2 times. totally 5 dosage, 1h after time administration does not press literature method intravenous injection 0.5% according to train of thought 5mlkg ^-1, ip0.6% acetic acid 10mlkg behind the 5min ^-1, take off at interval neck behind the 30min and put to death animal, wash the abdominal cavity with 5mlNS, get flushing and cross 3ml and add 0.1mol-NaOH0.1ml. and place 30min, with CL-770 type clinical spectroscopic photometer (590nm) colorimetric, the result carries out Student ' s check.

The result shows, nose peace relieving capsule 1.2gkg ^-1Dosage (be equivalent to clinical recommendation consumption 20 times) and TONGXIAO BIYAN PIAN 3.3gkg ^-1(be equivalent to clinical recommendation consumption 40 times) all obviously reduces mouse peritoneal flushing liquor Yi Wenenlan concentration: with the contrast of NS group, difference has significance (P＜0.05,0.01). and due to the prompting nose peace relieving capsule Dichlorodiphenyl Acetate, abdominal cavity capillary permeability increase has certain inhibitory action (table 1).

Table 1 nose peace relieving capsule is to the influence of capillary permeability

Group:	Dosage (gkg -1)	Crude drug amount (gkg -1)	Clinical recommended dose multiple	According to blue concentration (the μ g.ml of the train of thought -1)
					Normal saline	Equal-volume			0.37±0.11
Nose peace relieving capsule	0.3	4.5	5	0.36±0.23
						0.6	9	10	0.030±0.06 ++
1.2	18	20	0.28±0.07 +
				TONGXIAO BIYAN PIAN		3.8	13.2	40	0.20±0.11 +

N=10 X ± S. ⁺P＜0.05. ⁺⁺Compare with the normal saline matched group P＜0.01. ⁺P＜0.05. ⁺⁺P＜0.01. and TONGXIAO BIYAN PIAN group be (1-inspection) relatively

2, nose peace relieving capsule xylol causes the influence of the swollen account of mice auricular concha

50 of male ICR mouses. body weight 24 ± 2g. is divided into 5 groups at random, 10 every group. and be normal saline matched group, the nose peace basic, normal, high dosage group of relieving capsule and TONGXIAO BIYAN PIAN group.Irritate stomach respectively and give normal saline (NS), nose peace relieving capsule 0.3,0.6,1.2gkg ^-1(be equivalent to clinical recommendation consumption 5,10,20 times) and TONGXIAO BIYAN PIAN 3.8gkg ^-1(be equivalent to clinical recommendation consumption 40 times), every day 2 times, totally 5 dosage, time dosage 1h, every mouse right ear of reference literature is embrocated this 0.03ml of diformazan and is caused auricular concha swelling.15min puts to death mice.Laying the ears auricle with the card punch of diameter 8mm and weigh, is the swelling degree with left and right sides ear weight difference.And carry out Student ' s and check.

The result shows, behind high dose group during nose peace relieving capsule is low (be equivalent to clinical recommended dose 5, the 10 and 20 times) gastric infusion.The swelling of xylol induced mice auricular concha has the obvious suppression effect, and be dose-effect relationship, suppression ratio kills and is respectively 39.8,51.6 and 62.1%, compare with the normal saline matched group, difference is selective, and (P＜o.o1=compares with the TONGXIAO BIYAN PIAN group, difference does not have significance (P＞0.05), but the used dosage of TONGXIAO BIYAN PIAN has reached 40 times of clinical consumption, and prompting nose peace relieving capsule has the obvious anti-inflammatory and anti effect, and is better than TONGXIAO BIYAN PIAN (table 2).

Table 2 nose peace relieving capsule xylol causes the influence of mice auricle swelling

Group:	Dosage (gkg -1)	Crude drug amount (gkg -1)	Clinical recommended dose multiple	Swelling degree (mg)	Suppression ratio (%)
						Normal saline	Equal-volume			16.1±2.1
Nose peace relieving capsule	0.3 0.6 1.2	4.5 9 18	5 10 20	9.7±3.8 ++ 7.8±1.00 + 6.1±4.3 +	39.8 51.6 62.1
						TONGXIAO BIYAN PIAN	3.8	13.2	40	6.9±2.4 +	57.1

N=10, X ± S. ⁺⁺Compare with the normal saline matched group P＜0.01.Compare with the TONGXIAO BIYAN PIAN group ⁺P＞0.05. (1-check)

3, nose peace relieving capsule causes the influence that leukocyte is swum out of to rat carboxymethyl cellulose rope sodium

60 of healthy SD rats, body weight 170-220g, male and female half and half are divided into 6 groups at random, and 10 every group, promptly normal saline matched group, nose are pacified the basic, normal, high dosage group of relieving capsule, TONGXIAO BIYAN PIAN and aspirin group.Irritate stomach respectively and give normal saline (NS), nose peace relieving capsule 0.3,0.6,1.2gkg ^-1(be equivalent to clinical recommendation consumption 5,10 and 20 times), TONGXIAO BIYAN PIAN 3.8gkg ^-1(be equivalent to clinical recommendation consumption 40 times) and aspirin 0.2gkg ^-1, every day 1 time, totally 5 dosage.

Reference literature is all shaved hair with animal back, inject air 5ml to the back under the sterile working and form round balloon, 1h injects 1.5%CMC-Na 5ml after not inferior administration next day in capsule, CMC-Na liquid 0.02ml dilutes 20 times and 40 times with normal saline in 3h and 7.5h absorption capsule, light microscopic is counted leukocyte down on platelet, is scaled total white blood cells in every capsule again, after other gets 0.1ml normal saline 5ml mix homogeneously, 800ppm measured protein content with the precipitation blood cell with the bright method of coomassie in centrifugal 5 minutes.Data are carried out Student ' s check.

The result shows that under the stimulation of sodium carboxymethyl cellulose, leukocyte is swum out of in capsule, existing a certain amount of in 3.5h, 7.5h reaches very high, and is consistent with bibliographical information, and the plasma protein that oozes out in the capsule also increases in time.Each medication group of nose peace relieving capsule, TONGXIAO BIYAN PIAN and aspirin are swum out of all not to have obviously to leukocyte in the capsule due to the carboxylic first plug fiber rope sodium to be influenced.Compare P＞0.05 (table 3) with the normal saline group; Cause that plasma protein oozes out in the capsule but can significantly suppress sodium carboxymethyl cellulose, nose peace relieving capsule group still has dose dependent, high dose group (1.2g/kg, clinical consumption 20 times), and more than the effect 7.5h, all the other each groups have not had obvious effect (4) when 7.5h.

Table 3 nose peace relieving capsule causes the influence that leukocyte is swum out of to rat carboxymethyl cellulose rope sodium

Group:	Dosage (gkg -1)	Crude drug amount (gkg -1)	Clinical recommended dose multiple	Leukocyte count (10 in the CMC-Na capsule 9Individual/L)
						3h	7.5h
				Normal saline	Equal-volume					5.1±1.6	37.7±9.5
Nose peace relieving capsule	0.3 0.6 1.2	4.5 9 18	5 10 20			4.8±1.1 4.7±2.0 4.7±1.5	38.2±4.6 38.9±11.7 39.0±9.4
				TONGXIAO BIYAN PIAN	3.8			13.2	40	5.6±2.7	37.5±9.3
Aspirin	0.2					5.1±1.3	37.6±9.3

N=10, X ± X compare with the normal saline matched group ⁺P＞0.05. (1-check)

4, nose peace relieving capsule is to the influence of granuloma formation

66 of healthy SD rats, body weight 150-200g is divided into 6 groups at random, and 10 every group, promptly normal saline matched group, the basic, normal, high dosage group of nose peace relieving capsule, TONGXIAO BIYAN PIAN and an Ah phase woods are organized.

Back part of animal is shaved hair, lumbar injection 3% sodium pentobarbital 30mg kg ^-1Anesthetized animal, reference literature is implanted the scraps of paper about animal

Table 4 nose peace relieving capsule causes the influence that leukocyte oozes out to rat carboxymethyl cellulose rope sodium

Group:	Dosage (gkg -1)	Crude drug amount (gkg -1)	Clinical recommended dose multiple	Leukocyte count in the CMC-Na capsule (g/L)
						3h	7.5h
				Normal saline	Equal-volume					24.5±1.7	26.8±2.3
Nose peace relieving capsule	0.3 0.6 1.2	4.5 9 18	5 10 20			22.4±1.7 + 21.9±1.3 ++ 21.7±0.9 ++	27.5±1.2 25.9±1.3 24.4±1.7 +
				TONGXIAO BIYAN PIAN	3.8			13.2	40	22.2±2.6 +	25.3±5.4
Aspirin	0.2					20.4±1.0 ++	26.6±1.3

N=10, X ± S. ⁺P＜0.05, ⁺⁺Compare with the normal saline matched group P＜0.01; Compare P＞0.05 (1-check) with the TONGXIAO BIYAN PIAN group

Each 1 of shoulder, skin suture is put back to and is continued under the old terms to raise.The implantation scraps of paper were irritated stomach in inferior month respectively and are given normal saline (NS), nose peace relieving capsule 0.3,0.6,1.2gkg ^-1(be equivalent to clinical recommendation consumption 5,10 and 20 times), TONGXIAO BIYAN PIAN 3.8gkg ^-1(be equivalent to clinical recommendation consumption 40 times) and aspirin 0.2gkg ^-1, every day 1 time, totally 6 times.1h does not put to death animal after time administration, and paper boat and granulation tissue are extracted in the lump, weighs after 60 ℃ of baking boxs change roasting 24h, is the granulation net weight, and data are carried out Student ' s check.

The influence that table 5 nose peace relieving capsule forms granulation

Group:	Dosage (gkg -1)	Crude drug amount (gkg -1)	Clinical recommended dose multiple	Granuloma (mg)
					Normal saline	Equal-volume			86.5±23.8
Nose peace relieving capsule	0.3 0.6 1.2	4.5 9 18	5 10 20	74.8±18.1 73.5±10.3 75.6±15.1
					TONGXIAO BIYAN PIAN	3.8	13.2	40	71.2±13.5
Aspirin	0.2			62.7±8.7 ++

N=10, X ± X, ⁺⁺P＜0.05. and normal saline matched group are relatively ⁺(1-check)

The result shows that aspirin is to the obvious suppression effect that is formed with of granulation midship, and nose peace relieving capsule and TONGXIAO BIYAN PIAN have the trend that suppresses the swollen formation of internal bud, but do not reach the remarkable meaning of statistics (table 5).A little less than the easypro propagation red horse effect to the moxibustion disease later stage of prompting nose peace, and its antiinflammatory action characteristics also are different from aspirin.

Two, the bacteriostasis of nose peace relieving capsule

The streptococcus pneumoniae (31001) that lyophilization is preserved: Jia Xingrongxuexinglianqiujun (32205): staphylococcus aureus (26001): after Bacillus proteus (14002) reference culture recover in the corresponding liquid culture medium, transferred species to corresponding Nutrient agar flatly pull, 37 ℃ of cultivations 24 hours on the blood agar plate.The single bacterium colony normal saline of picking dilution back with McFar Land opacity tube estimate than turbid be 3 * 10 ⁵Cfu/ml is standby.

Adopt the test tube double dilution method to measure nose peace relieving capsule, TONGXIAO BIYAN PIAN minimal inhibitory concentration (MIC) to above-mentioned test organisms.

The result shows, nose peace relieving capsule all has inhibitory action to upper respiratory tract encountered pathogenic bacteria streptococcus pneumoniae, staphylococcus aureus, Jia Xingrongxuexinglianqiujun and Bacillus proteus, minimal inhibitory concentration is respectively 25.0,50.0,50.0 and 25.0mg/ml, all is better than TONGXIAO BIYAN PIAN (table 6).

Table 6 nose peace relieving capsule is to the minimal inhibitory concentration (MIC) of upper respiratory tract common pathogen

Test sample (mg/ml)	Streptococcus pneumoniae	Staphylococcus aureus	The first streptococcus	Bacillus proteus
					Nose peace relieving capsule	25.0	50	50	25
TONGXIAO BIYAN PIAN	125	125	125	31.25
					Ampicillin	＜0.004	＜0.004	＜0.004	＜0.004

Three, nose peace relieving capsule waited the influence of sensitive media to 5-HT and histamine

Get male SD rat by Vanc and offcrmecier method, body weight 200-250g is with the animal sacrificed by exsanguination that breaks end.Cutting open the belly immediately extracts golden stomach, downcuts the stomach bottom branch, along the stringer stomach flesh bar of greater gastric curvature clip 1.5 * 0.5cm.

Healthy guinea pig, male and female are regardless of, body weight 300-350g.Cavia porcellus tapped the head cause dusk, after the sacrificed by exsanguination, open abdomen rapidly, fetch one section of intestinal, separate mesentery, intestinal contents is rinsed well, and it is standby to be cut into the 1.0-1.5cm intestinal segment with krebs solution along intestinal wall.

Gastrointestinal bar or intestinal tube one end are fixed in Magnus' bath ventilation hook, and the other end is connected in tonotransducer, tranquillization load 1.0g; 37 ± 1 ℃ of nutritional solution constant temperature, logical O ₂The about 1h of balance, every therebetween 15min changes liquid once, with U-135C self-balancing recorder record shrinkage curve.

The result shows: nose peace relieving capsule and TONGXIAO BIYAN PIAN all can not antagonism 5-HT (8 * 10 ^-9G/L) smooth muscle contraction and histamine (5 * 10 at the bottom of the rat stomach that causes ^-5G/L) the isolated guinea pig ileum smooth muscle contraction that causes, prompting nose peace relieving capsule and TONGXIAO BIYAN PIAN do not have obvious influence to crossing sensitive media.

Four, capsaicin is caused the influence of rhinitis

56 of healthy guinea pigs, male and female are regardless of, and body weight 180-230g is divided into 7 groups at random, and 8 every group, promptly normal saline matched group, nose are pacified the basic, normal, high dosage group of relieving capsule, TONGXIAO BIYAN PIAN, ketotifen and morphine group.Except that morphine group and ketotifen divide before moulding before the 30min subcutaneous injection 3mg/kg and moulding the 1h gastric infusion 10mg/kg, all the other each groups are irritated stomach respectively and are given normal saline (NS), nose peace relieving capsule 0.3,0.6,1.2gkg ^-1, TONGXIAO BIYAN PIAN 3.8gkg ^-1, every day 1 time. totally 3 days.

1h (30min behind the morphine group subcutaneous injection after the not inferior administration.Reference literature splashes into the capsaicin 50 μ L of 1mM in the right nostril of Cavia porcellus, cause sneeze and scratch rhinoreaction, counts sneeze and the number of times of scratching nose in the 30min respectively, and with the order of severity of reaction rhinitis, data are carried out Student ' s (1-check).

The result shows: after splashing into capsaicin in the nostril, cause the tangible sneeze of Cavia porcellus and scratch rhinoreaction, consistent with reported in literature, give nose peace relieving capsule 1.2g/kg (be equivalent to clinical recommended dose 20 times), morphine 3mg/kg and ketotifen 0g/k and all obviously suppress the sneeze reaction that capsaicin causes, compare with the normal saline matched group, difference has significance, and (there is the trend that reduces the sneeze number of times P＜0.05,0.01, TONGXIAO BIYAN PIAN, but do not reach statistically significant difference (table 7).Each dosage group of nose peace relieving capsule, TONGXIAO BIYAN PIAN and morphine also significantly suppress the rhinoreaction of scratching that capsaicin causes, compare with the normal saline matched group, difference has significance (P＜0.05,0.01 nose peace relieving capsule presents the docs-effect dependency, the drug effect of the nose peace relieving capsule of 10 times of clinical recommended amounts is equivalent to the TONGXIAO BIYAN PIAN of 40 times of clinical consumptions; The ketotifen group does not have the obvious suppression effect to the rhinoreaction of scratching that capsaicin causes.

Conclusion and discussion

Nose peace relieving capsule system has heat-clearing and toxic substances removing by the compound Chinese medicinal preparation of Yunnan Jinbi Pharmaceutical Co., Ltd.'s development.The effect that dispelling wind is sensible is mainly with giving diseases such as treatment acute and chronic rhinitis, nose air transport inflammation.Pharmacodynamic study shows:

1, capsule nose peace relieving capsule its tangible antiinflammatory action is arranged, inflammation acute stage especially

Nose peace relieving capsule 0.3,0.6,1.2gkg ^-1(clinical recommended dose 5,10 and 20 times) is equivalent to crude drug in whole 6,12 and 24gkg ^-1Significantly alleviate inflammatory swelling, high dose still can alleviate the capillary permeability increase that the chemical irritation agent causes, dosage is according to grain husk

Table 7 nose peace relieving capsule causes the Cavia porcellus sneeze and scratches the influence of rhinoreaction after to capsaicin

Group:	Dosage (gkg -1)	Crude drug amount (gkg -1)	Clinical recommended dose multiple	Sneeze time/30min	Suppression ratio %	Scratch nose/30min	Suppression ratio %
								Normal saline	Equal-volume			11.9±4.4		50.4±12.3
Nose peace relieving capsule	0.3 0.6 1.2	4.5 9 18	5 10 20	12.0±5.4 9.1±1.4 7.9±2.5 +	/ 23.5 33.6	34.3±11.0 + 30.1±9.7 + 28.8±7.8 ++	31.9 40.3 42.9
								TONGXIAO BIYAN PIAN	3.8	13.2	40	8.3±3.5	30.3	32.6±11.7 +	35.3
Ketotifen	0.01			7.9±2.7 +	33.6	52.5±17.9	/
								Morphine	0.003			5.8±1.6 ++	51.3	9.25±3.01 ++	81.6

N=10, X ± S. ⁺P＜0.05, ⁺⁺Compare with the normal saline matched group P＜0.01; Relatively P＞0.05 (1-check) property suppressing the interior plasma protein of capsule with the TONGXIAO BIYAN PIAN group oozes out.But leukoplania in the capsule there is not obvious shadow noon, the trend that has the inflammation-inhibiting granulation to form in addition, prompting nose peace relieving capsule is stronger to the acute stage effect of inflammation noon, and is comparatively favourable to giving nasal obstruction, the watery nasal discharge of alleviating rhinitis, a little less than the exudative process and proliferative lesion effect to the inflammation middle and advanced stage.

2, nose peace relieving capsule is inhibited

Nose peace relieving capsule has certain inhibitory action to upper respiratory tract encountered pathogenic bacteria streptococcus pneumoniae, staphylococcus aureus, first type haemolysis baby streptococcus and change open form bar mattress, is better than sensible rhinitis, but is weaker than ampicillin sodium injection.Prompting nose peace relieving capsule has certain therapeutical effect to the blended bacterial infection of rhinitis.

3. nose peace relieving capsule is to crossing the effect of sensitive media 5-HT and histamine

Nose peace relieving capsule and TONGXIAO BIYAN PIAN all can not antagonism 5-HT and histamine due to the smooth muscle contraction reaction.Prompting nose peace relieving capsule does not have bright influence to crossing sensitive media.

4, nose peace relieving capsule alleviates Cavia porcellus rhinitis reaction due to the capsaicin

Splash into capsaicin according to document-report intranasal and can cause rhinitis, produce sneeze and scratch rhinoreaction, its mechanism discharges P material and tachykinin with sensory nerve, and central nervous system's nociceptive reflex is relevant, and histamine effect therein is very weak.Thereby ketotifen alleviates sneeze and scratches rhinoreaction by the effect that suppresses tachykinin, morphine is then by activating the not release of the opiate receptor adjusting tachykinin of the tip of sensory nerve, suppress the injury signal of P material mediation or pass through the central sedation, thereby alleviate sneeze and scratch rhinoreaction; Nose peace relieving capsule is similar to the effect characteristics of morphine, also there are other pharmacologically active in the sneeze that capsaicin is caused and scratch rhinoreaction inhibitory action is all arranged, prompting nose peace relieving capsule except that having antiinflammatory, effect such as antibacterial, as inhibitory action, be worth further research to tachykinin, P material.

In sum, nose peace relieving capsule has tangible antiinflammatory action. and especially stronger: that the respiratory tract common pathogen is had certain inhibitory action to the inflammatory swelling effect of inflammation acute stage; Rhinitis due to the capsaicin is also had obvious inhibitory action, and its drug effect is better than TONGXIAO BIYAN PIAN, is worth further investigation.

The acute toxicity test of nose peace relieving capsule its mouse oral

This experiment employing ICR mice of making a summary carries out the acute toxicity test of the heavy dose of multiple dosing of its mouse oral to nose peace relieving capsule, does not see after the administration that obvious toxic reaction appears in animal.Its measurement result: MTD is the 50.00g/80ml/kg body weight.

1, experiment purpose

Observe the test sample heavy dose and repeatedly give the acute toxic reaction and the death condition that are produced after the laboratory animal.

2, material

21, test sample: nose peace relieving capsule includes brown particle, 0-4g/ grain, 6/time, every day three times.Its clinical consumption is calculated as the 0.14g/kg body weight by the 50kg body weight.Provide by Yunnan Jin Bi drugmaker.

2.2, laboratory animal: 20 of healthy ICR mices, male and female half and half, female Mus body weight are that the male Mus of 19.62g ± 1.19. is 19.74g ± 1.34.Provide by animal housing of natural drug pharmacology key lab of unming Medical College.The animal quality certification: No. the 9804th, 9806, the real moving card in Yunnan.

3.0, method: selecting body weight is 20 of the healthy ICR mices of 18～22g, male and female half and half.Take by weighing nose peace relaxation grain 25g and add a small amount of eliminating cold for resuscitation water logging bubble, grind, move to and add water to 40ml in the measuring cup, it is 62.50% brown viscous solution, press capacity gastric infusions such as 0.8ml/10g body weight, divide secondary to give, each five hours at interval, observed seven days continuously after the administration, the record animal poisons and death condition.

4.0, result and evaluation: 20 mouse stomaches give not see that obvious toxic reaction appears in animal behind the test sample, observed continuously in seven days, all animals survival, ordinary circumstance is good, activity freely, feed, drinking-water are normal.During off-test, the animal body weight average has growth, and female Mus is 21.78g ± 0.87, and male Mus is 22.59g ± 0.58.It is the 50.00g/80mt/kg body weight that the result records nose peace relieving capsule its mouse oral MTD.Be 277 times of clinical application amount.

5.0 list of references:

5.1 the study of tcm new drug guide, the management of bureau of drug administration of Ministry of Health of the People's Republic of China.

Claims (10)

1, a kind of drug regimen that is used for the treatment of coryza, it is characterized in that drug regimen prescription essence contains the Radix Astragali, Radix Scutellariae, Herba Asari, Rhizoma Cimicifugae, DAZHUIFENG, Herba Inulae cappae, each constituent and composition thereof are in this pharmaceutical preparation: Radix Astragali 0.1-99.9%, Radix Scutellariae 0.1-99.9%, Herba Asari 0.1-99.9%, Rhizoma Cimicifugae 0.1-99.9%, DAZHUIFENG 0.1-99.9%, Herba Inulae cappae 0.1-99.9%, surplus is the medicine adjuvant.

2, a kind of drug regimen that is used for the treatment of coryza according to claim 1, it is characterized in that in this pharmaceutical preparation that each constituent and composition essence thereof contain the medical material scope: Radix Astragali 10-20%, Radix Scutellariae 10-20%, Herba Asari 2-5%, Rhizoma Cimicifugae 3-9%, DAZHUIFENG 20-30%, Herba Inulae cappae 30-40%, surplus is the medicine adjuvant.

3, the drug regimen that is used for the treatment of coryza according to claim 1 and 2 is characterized in that in this pharmaceutical preparation that each constituent and composition essence thereof contain the best ratio range of medical material: Radix Astragali 12.83%-15.46%; Radix Scutellariae 12.83%-15.46%; Herba Asari 2.3%-2.63%; Rhizoma Cimicifugae 5.3%-6.36%; DAZHUIFENG 24%-29.33%; Herba Inulae cappae 33.33%-40%.

4, the drug regimen that is used for the treatment of coryza according to claim 3, it is characterized in that the best proportioning that every 100g extract (fluid extract or dry extract) contains medical material is: the Radix Astragali: 106.25 grams, Radix Scutellariae: 106.25 grams, Herba Asari: 18.75 grams, Rhizoma Cimicifugae: 43.75 grams, DAZHUIFENG: 200 grams, Herba Inulae cappae: 275 grams, then amount to 750 grams, through obtaining 100 gram extractum or dry extracts (active ingredient) after the extraction process by above-mentioned six kinds of medical materials.

5, according to claim 1 or 2 described fluid extract or the dry extract preparation technologies that are used for the treatment of the coryza drug regimen, it is characterized in that: (1) cleans the Radix Astragali, Radix Scutellariae, Herba Asari, Rhizoma Cimicifugae, DAZHUIFENG, Herba Inulae cappae Six-element pharmaceutical decocting piece, the water logging bubble that adding 9-12 doubly measures 2-4 hour, supply the water yield by water absorption rate before decocting, decocted 1-2 hour for the first time;

(2) for the second time, the decocting that respectively adds 6 times of amounts for the third time boiled 0.5-1 hour, filter, merge three times filtrate, being concentrated into relative density is 1.05-1.10, by 0.4% adding pretreating agent B, behind 50 ℃ of insulation 4h, boil the 15-30min enzyme denaturing, be cooled to 50 ℃, add medicinal clarifier component, mixing by 4-8%, be warming up to 70 ℃ again, press 2-4% and add pretreating agent B component, stir evenly, behind the adding clarifier, heat to about 80 ℃ 30 minutes, when treating that temperature is reduced to 50 ℃, add Pulvis Talci, be incubated 30 minutes by 0.5% of amount of liquid medicine;

(3) standing over night is drawn supernatant, filter, filtrate decompression concentrate fluid extract, dry dry extract.

6, according to claim 1 or 2 described fluid extract or the dry extract preparation technologies that are used for the treatment of the coryza drug regimen, it is characterized in that: (1) cleans the Radix Astragali, Radix Scutellariae, Herba Asari, Rhizoma Cimicifugae, DAZHUIFENG, Herba Inulae cappae Six-element pharmaceutical decocting piece, the water logging bubble that adding 9-12 doubly measures 2-4 hour, supply the water yield by water absorption rate before decocting, decocted 1-2 hour for the first time;

(2) second and third time decocting of respectively adding 6 times of amounts boiled 0.5-1 hour, filtered, and merged three times filtrate, and being concentrated into relative density is 1.18-1.26, and adding 2-5 doubly measures 95% ethanol, stirs evenly;

(3) leave standstill more than 24 hours, draw supernatant liquid filtering, filtrate decompression concentrate fluid extract, dry dry extract.

7, fluid extract or the dry extract preparation technology who is used for the treatment of the coryza drug regimen according to claim 5, it is characterized in that the pretreating agent that adds, medicinal clarifier, excipient, solvent, antiseptic, correctives, PH regulator, isoosmotic adjusting agent, it is respectively:

Pretreating agent: pretreating agent B (being called for short the ZTC-pretreating agent), production unit: Beijing became the clarification technique company limited in positive day;

Medicinal clarifier: ZTC-II (ZTC1+1 natural clarifying agent, production unit: Beijing became the clarification technique company limited in positive day), ZTC-III (ZTC1+1 natural clarifying agent, production unit: Beijing became the clarification technique company limited in positive day), ethanol;

Excipient: gelatin, glycerol, dextrin, starch, silicon dioxide, magnesium stearate, microcrystalline Cellulose, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, active carbon, Polyethylene Glycol, polyvinylpyrrolidone, tween 80;

Solvent: vegetable oil (Oleum Arachidis hypogaeae semen, Oleum Brassicae campestris, walnut oil), glycerol, propylene glycol, liquid paraffin, Cera Flava; Purified water;

Antiseptic: benzoic acid and sodium benzoate, methyl parahydroxybenzoate, ethyl ester, propyl ester, butyl ester (parabens);

Correctives: Mel, stevioside, saccharin sodium;

PH regulator: hydrochloric acid, acetic acid, citric acid, sodium hydrogen phosphate, sodium dihydrogen phosphate;

Isoosmotic adjusting agent: sodium chloride, glucose.

8, fluid extract or the dry extract preparation technology who is used for the treatment of the coryza drug regimen according to claim 6, it is characterized in that the pretreating agent that adds, medicinal clarifier, excipient, solvent, antiseptic, correctives, PH regulator, isoosmotic adjusting agent, it is respectively:

Pretreating agent: pretreating agent B (being called for short the ZTC-pretreating agent), production unit: Beijing became the clarification technique company limited in positive day;

Medicinal clarifier: ZTC-II (ZTC1+1 natural clarifying agent, production unit: Beijing became the clarification technique company limited in positive day), ZTC-III (ZTC1+1 natural clarifying agent, production unit: Beijing became the clarification technique company limited in positive day), ethanol;

Excipient: gelatin, glycerol, dextrin, starch, silicon dioxide, magnesium stearate, microcrystalline Cellulose, sodium carboxymethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, active carbon, Polyethylene Glycol, polyvinylpyrrolidone, tween 80;

Solvent: vegetable oil (Oleum Arachidis hypogaeae semen, Oleum Brassicae campestris, walnut oil), glycerol, propylene glycol, liquid paraffin, Cera Flava; Purified water;

Antiseptic: benzoic acid and sodium benzoate, methyl parahydroxybenzoate, ethyl ester, propyl ester, butyl ester (parabens);

Correctives: Mel, stevioside, saccharin sodium;

PH regulator: hydrochloric acid, acetic acid, citric acid, sodium hydrogen phosphate, sodium dihydrogen phosphate;

Isoosmotic adjusting agent: sodium chloride, glucose.

9, be used for the treatment of the dosage form of coryza drug regimen according to claim 1 or 2 described making, it is characterized in that: medicine composition is: granule, hard capsule, enteric coated capsule, microcapsule, tablet, Film coated tablets, enteric coated tablet, drop pill, soft capsule, mixture (oral liquid), nasal drop;

Granule is that the medicine dry extract is pulverized, and crosses the 80-100 sieve, with starch, dextrin, stevioside auxiliary materials and mixing, granulation, drying, granulate, packing, promptly;

Medicament capsule or enteric coated capsule are that the medicine dry extract is pulverized, and cross the 80-100 sieve, with silicon dioxide, magnesium stearate, microcrystalline Cellulose, ethyl cellulose mixing, granulation, granulate, are packed in hard capsule or the enteric coated capsule, promptly;

Microcapsule is that the medicine dry extract is pulverized, and crosses 200 mesh sieves, with hydroxypropyl cellulose granulation, dry, granulate, the capsule grain is placed in the coating machine, adds the alcoholic solution of Polyethylene Glycol and ethyl cellulose, makes microcapsule, is packed into hard capsule or compacting in flakes, promptly;

Tablet is each supplementary material weighing, mixing, granulation, drying, the tabletting with the prescription consumption, promptly;

Film coated tablets or enteric coated tablet are that the medicine dry extract is pulverized, and cross 80 mesh sieves, with starch, microcrystalline Cellulose, magnesium stearate, magnesium stearate mixing, granulation, drying, compacting in flakes, bag film-coat or enteric coating, promptly;

Soft capsule is that the medicine dry extract is pulverized, and crosses 200 mesh sieves, with walnut oil, Cera Flava, gelatin, glycerol, water auxiliary materials and mixing, makes soft capsule, promptly;

Drop pill is that the medicine dry extract is pulverized, and crosses 200 mesh sieves, with the Polyethylene Glycol auxiliary materials and mixing, makes drop pill, promptly;

Mixture (oral liquid) is that the easypro fluid extract of nose peace is added purified water, heating for dissolving, and adding Mel, active carbon boil, filtered while hot, cold preservation, filtration, and filtrate adds citric acid, and add purified water and be adjusted to amount of preparation, packing, sterilization, promptly;

Nasal drop is that fluid extract is added purified water, heating for dissolving, add active carbon (0.5%), boil, filter, filtrate cold preservation, draw supernatant liquid filtering, filtrate adds sodium chloride (0.7%) regulates, and adding sodium dihydrogen phosphate (5%) and sodium hydrogen phosphate (5%) adjusting pH value is 5.5-7.5, adds ethyl hydroxybenzoate, add purified water again and be adjusted to amount of preparation, packing, promptly.

10, a kind of purposes that is used for the treatment of the coryza drug regimen, the special character that it is characterized in that drug regimen are to be used for the treatment of acute rhinitis (traditional Chinese medical science belongs to wind card category), chronic rhinitis (traditional Chinese medical science belongs to the stuffy nose category), atrophic rhinitis's (traditional Chinese medical science belongs to the atrophic rhinitis category), caseous rhinitis (traditional Chinese medical science belongs to the nasal sinusitis category), acute and chronic nasal sinusitis and purulent sinusitis's (traditional Chinese medical science belongs to the nasal sinusitis category), allergic rhinitis or allergic rhinitis (traditional Chinese medical science belongs to the allergic rhinitis category) rhinitis class disease.