CN100348217C - Rhinological disease-treating pharmaceutical compositions and its preparing method - Google Patents
Rhinological disease-treating pharmaceutical compositions and its preparing method Download PDFInfo
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Abstract
The present invention relates to a medicinal composition for treating nose diseases and the preparing process thereof. The medicine is prepared from the following raw materials (by weight portions) of 68.7 to 618 portions of patchouli, 85.7 to 771 portions of xanthium, 85.7 to 771 portions of centipeda, 43 to 387 portions of ephedra, 43 to 387 portions of wild chrysanthemum flower, 55.3 to 498 portions of Chinese angelica root, 36.3 to 327 portions of baikal skullcap root, 4.3 to 39 portions of pig gall powder, 0.3 to 2.77 portions of mint oil and 0.3 to 3 portions of chlorpheniramine maleate. The preparing process of the medicine comprises that each component is weighed according to weight proportion; water is added into the patchouli, the xanthium, the centipeda, the ephedra and the wild chrysanthemum flower for being decocted and extracted to be made into dry paste powder or thick paste; the Chinese angelica root is extracted by alcohol of the concentration of 50% to 90%, and the Chinese angelica root is made into dry paste powder or thick paste; the scutellaria root is extracted by water and is made into dry paste powder or thick paste; the dry paste powder or the thick paste is made into preparation intermediate body and then is made into preparation by adding the pig gall powder, the mint oil and the chlorpheniramine maleate. The medicine has good curative effects on nose diseases especially on acute and chronic rhinitis and allergic rhinitis.
Description
Technical field
The present invention relates to a kind of new pharmaceutical composition that is used for the treatment of Rhinological disease, relate in particular to a kind of with the Chinese herbal medicine be primary raw material make be used for the treatment of pharmaceutical composition of Rhinological disease and preparation method thereof.
Background technology
Rhinological disease is a common clinical, frequently-occurring disease.Theory of Chinese medical science thinks that nose is the door of gas discrepancy, and department's olfactory sensation helps pronunciation, under lung system.Nose is a key outside the lung, and " element asks YIN YANG classification of natural phenomena big opinion " said: " lung controlling nose ... is nose at key ", point out the relation of lung and nose." element is asked a vessles length piece of writing " said: " lung-QI connecting with the nose, lung and then nose can know good and foul smells." a Ling Shu Miraculous Pivot or Divine Axis Benshen piece of writing " said: " insufficiency of lung-QI is nasal obstruction then ".As seen lung and nose are in close relations.The two is coordinated on physiological function mutually, cooperatively interacts, and then lung qi is advocated, and breathes gentlely, and nose key tonneau can be known good and foul smells.If insufficiency of lung-QI, or exopathogen criminal lung then can cause nose key generation pathological changes.
Clinical common traditional Chinese medical science Rhinological disease mainly contains the cold nasal obstruction, stuffy nose, allergic rhinitis (or claiming nose to sneeze), nasal sinusitis etc.
The cold nasal obstruction is because the diseases caused by exogenous pathogenic factor ailment said due to cold or exposure causes that cardinal symptom is rhinocleisis, watery nasal discharge, sneeze, even anosmia.The primary disease four seasons all can take place, and the course of disease is shorter, and the general a few days can heal, and is equivalent to the acute rhinitis of modern medicine indication.
Stuffy nose is meant when when nasal obstruction is light heavy, or bilateral nose key alternately stops up, and takes place repeatedly, prolongedly do not heal, even the hyposmia person.The chronic rhinitis that is equivalent to the modern medicine indication.
Allergic rhinitis is meant that with rhinocnesmus, sneeze, snivel, nasal obstruction unexpected and outbreak repeatedly be the cacorhinia of feature.The primary disease of repeatedly touching upon in " interior warp ".Say as " element ask arteries and veins separate a piece of writing ": " last person then its grandson's network is also lunar for the then headache of so-called objective grandson's arteries and veins, allergic rhinitis, abdominal distention person, Yang Ming and in last, so headache, allergic rhinitis, abdominal distention are also ".Primary disease is equivalent to the allergic rhinitis of modern medicine indication.
The medicine of the common treatment Rhinological disease in market mainly contains rhinitis tablet up to now, bidouyan mixture, bidouyan koufuye, HUODAN WAN, leaves of pulse plants gallbladder sheet, QIANBAI BIYAN PIAN, DITONG BIYAN SHUI, BIYUANSHU KOUFUYE, tens kinds of BIYAN QINGDU KELI etc., the contained main component of these medicines has: Herba Pogostemonis, Pulvis Fellis Suis, Flos Chrysanthemi Indici, Fructus Xanthii, Rhizoma Paridis She Pao le, Radix Zanthoxyli, Spica Prunellae, Radix Gentianae, Radix Codonopsis, Flos Magnoliae, Herba Menthae, the Radix Angelicae Dahuricae, Radix Scutellariae, Fructus Gardeniae, Radix Bupleuri, Herba Asari, the Radix Astragali, Radix Platycodonis, Herba Taraxaci, Rhizoma Acori Graminei, Herba Senecionis Scandentis, Herba Selaginellae, Rhizoma Et Radix Notopterygii, Semen Cassiae, Herba Ephedrae, Rhizoma Chuanxiong, Herba Schizonepetae, Poria, Caulis Clematidis Armandii, Radix Saposhnikoviae, Fructus Forsythiae, Fructus Schisandrae Chinensis, the Rhizoma Anemarrhenae, Radix Glycyrrhizae, Cortex Phellodendri etc.They are mainly used in treatment wind and cold heat-transformation, pyretic toxicity, or the diseases such as nasal obstruction, nasosinusitis headache, nasopharyngeal sore pain, nasopharynx inflam mation, sinusitis, nasal sinusitis and acute and chronic rhinitis that cause of other exopathogenic factors, and indivedual medicines relate to allergic rhinitis.They all in various degree exist the defective of taking stopgap measures and can not effect a permanent cure.
Summary of the invention
The object of the invention provides a kind of pharmaceutical composition for the treatment of Rhinological disease.This pharmaceutical composition plays the effect of heat clearing away, lung qi dispersing by oral or external, improves various clinical signs or symptoms such as acute and chronic rhinitis, allergic rhinitis thereby reach obvious, and then fundamentally treats Rhinological disease.
Another object of the present invention provides this preparation of drug combination method.
The present invention seeks to be achieved through the following technical solutions.
The invention provides a kind of pharmaceutical composition for the treatment of Rhinological disease, this pharmaceutical composition comprises following raw materials by weight proportions: 68.7～618 parts of Herba Pogostemonis, 85.7～771 parts of Fructus Xanthii, 85.7～771 parts of Herba Centipedae, 43～387 parts in Herba Ephedrae, 43～387 parts of Flos Chrysanthemi Indicis, 55.3～498 parts of Radix Angelicae Sinensis, 36.3～327 parts of Radix Scutellariaes, 4.3～39 parts of Pulvis Fellis Suiss, 0.3～2.77 part of Oleum menthae, 0.3～3 part of chlorphenamine maleate.
Preferably: 103～412 parts of Herba Pogostemonis, 128.5～514 parts of Fructus Xanthii, 128.5～514 parts of Herba Centipedae, 64.5～258 parts in Herba Ephedrae, 64.5～258 parts of Flos Chrysanthemi Indicis, 83～332 parts of Radix Angelicae Sinensis, 54.5～218 parts of Radix Scutellariaes, 6.5～26 parts of Pulvis Fellis Suiss, 0.46～1.84 part of Oleum menthae, 0.5～2 part of chlorphenamine maleate.
Most preferably: 206 parts of Herba Pogostemonis, 257 parts of Fructus Xanthii, 257 parts of Herba Centipedae, 129 parts in Herba Ephedrae, 129 parts of Flos Chrysanthemi Indicis, 166 parts of Radix Angelicae Sinensis, 109 parts of Radix Scutellariaes, 13 parts of Pulvis Fellis Suiss, 0.92 part of Oleum menthae, 1 part of chlorphenamine maleate.
The material medicine of respectively distinguishing the flavor of that the present invention is used: Herba Pogostemonis, Fructus Xanthii, Herba Centipedae, Herba Ephedrae, Flos Chrysanthemi Indici, Radix Angelicae Sinensis, Radix Scutellariae, Pulvis Fellis Suis, Oleum menthae, chlorphenamine maleate, specification all meet national medical standard, can buy at pharmacy to obtain.
The present invention also provides the method for the pharmaceutical composition for preparing above-mentioned treatment Rhinological disease, and this method may further comprise the steps:
(1) takes by weighing each component by described weight proportion;
(2) Herba Pogostemonis, Fructus Xanthii, Herba Centipedae, Herba Ephedrae, the Herba Dendranthematis indici of described weight is placed in the same container decocts with water extraction, filter, filtrate is dried to dried cream powder or thick paste after concentrating, and is standby; The Radix Angelicae Sinensis of described weight is added the ethanol of 50%～90% concentration, and reflux, extract, filters, filtrate recycling ethanol and concentrate after, be dried to dried cream powder or thick paste, standby; The Radix Scutellariae of described weight is decocted with water extraction, filter, filtrate merges, and after concentrating, is dried to dried cream powder or thick paste, and is standby; Get above-mentioned gained dried cream powder or thick paste, add Pulvis Fellis Suis and the Oleum menthae and the chlorphenamine maleate of described weight, mixing is made the preparation intermediate, makes preparation through preparations shaping technology again, promptly.
Pharmaceutical composition of the present invention can be prepared into any acceptable clinically suitable formulations by this area conventional method, for example can be tablet, capsule, granule, powder, pill, oral liquid, syrup, drop pill, injection, aerosol, nasal drop, spray, ointment, emplastrum; Be preferably solid orally ingestible, for example tablet, capsule, granule, powder, pill etc.
The present composition based on Chinese medicine to pathogenetic research of Rhinological disease deep layer and Therapeutic Principle thereof, simultaneously according to the pharmaceutical research achievement, filter out that heat-clearing and toxic substances removing, lung qi dispersing are sensible, the crude drug of reducing swelling and alleviating pain,, be prepared from according to certain weight proportion according to the theory of Chinese medical science prescription.
The compatibility of pharmaceutical composition of the present invention is according to being:
According to the understanding of theory of Chinese medical science to the rhinitis etiology and pathogenesis, this product is intended antiinflammatory, heat clearing away, and eliminating stasis to stop pain, expelling wind and cold, the turbidity removal of drying is the main rule of treatment.Flos Chrysanthemi Indici, suppressing the hyperactive liver, heat clearing away, detoxifcation, pain relieving; Radix Scutellariae, Fel Sus domestica, clearing up internal heat by using drugs of bitter in taste and cold in nature has the merit of subduing swelling and detoxicating; Fructus Xanthii, Herba Centipedae are dispeled the wind, dampness removing, sensible, dispersing wind and cold; Herba Ephedrae goes into lung meridian, opening lung-energy; Oleum menthae is separated wind heat, refreshment, share with Herba Ephedrae and separates pain of top, top altogether; Herba Pogostemonis is dispeled the wind, removing dampness is turbid, the compatibility Pulvis Fellis Suis, and the good medicine for ancient prescription treatment rhinitis is applicable to the rhinitis that the gallbladder internal organs is hot and suffocating; More help in Radix Angelicae Sinensis tonify deficiency, promoting the circulation of blood, analgesia, have the effect of eliminating the rhinitis headache concurrently; Chlorphenamine maleate and Radix Scutellariae all have antihistamine effect, and anaphylactic disease is had curative effect preferably.More than all medicine the monarch and his subjects compatibilities, play altogether that heat-clearing and toxic substances removing, lung qi dispersing are sensible, the effect of reducing swelling and alleviating pain.
Using method: oral pharmaceutical composition of the present invention, calculate with contained crude drug amount in the pharmaceutical composition, 3 times on the one, each 5g; External pharmaceutical composition of the present invention calculates with contained crude drug amount in the pharmaceutical composition, and 3 times on the one, each 5g.
Prove that through toxicity test medicine of the present invention has no side effect to human body, the blood of human body, internal organs etc. are not had harmful effect.
Prove that through animal experiment and clinical trial medicine of the present invention is to nose diseases, especially acute rhinitis, chronic rhinitis and allergic rhinitis have good efficacy.Effect aspect antiinflammatory, antiallergic is significantly better than pure Chinese medicine part and Western medicine part in the compositions, illustrate that pure Chinese medicine part partly has the obvious synergistic effect with Western medicine in the medicine of the present invention, and treatment acute rhinitis, chronic rhinitis and allergic rhinitis are had good efficacy.This illustrates that also Chinese and western drugs combined treatment acute rhinitis, chronic rhinitis and allergic rhinitis are one of medicine characteristics of the present invention.
The specific embodiment
Further describe the present invention by the following examples, it should be understood that these embodiment only are used for the purpose of illustration, never limit the scope of the invention.
Embodiment 1
The preparation of emplastrum (comprising rubber-emplastrum, cataplasma, patch)
(1) takes by weighing Herba Pogostemonis 400g, Fructus Xanthii 130g, Herba Centipedae 500g, Herba Ephedrae 255g, Flos Chrysanthemi Indici 65g, Radix Angelicae Sinensis 330g, Pulvis Fellis Suis 10g, Radix Scutellariae 210g, chlorphenamine maleate 2g, Oleum menthae 1.8g.
(2) arrangement of medical material: Herba Pogostemonis, Radix Angelicae Sinensis, Herba Ephedrae, Fructus Xanthii, Herba Centipedae, Flos Chrysanthemi Indici and Radix Scutellariae are removed impurity respectively clean medical material;
(3) preparation of thick paste: above ten flavors, Herba Pogostemonis, Fructus Xanthii, Herba Centipedae, Herba Ephedrae and Flos Chrysanthemi Indici are added the water of 10 times of medical material weight that feed intake, pressurization 0.1MPa decocts, and extracts secondary continuously, and each 1 hour, extracting solution was concentrated in right amount, and it is standby to be dried to thick paste; Radix Angelicae Sinensis extracts secondary with the ethanol continuous backflow of 1650g90% concentration, and each 3 hours, filter, filtrate recycling ethanol also is concentrated in right amount, and it is standby to be dried to thick paste; Radix Scutellariae adds the water of 10 times of medical material weight that feed intake, and pressurization 0.1MPa extracts secondary continuously, and each 1 hour, it was 1.14～1.18 that extracting solution is concentrated into relative density, and it is standby to be dried to thick paste; Above-mentioned gained thick paste is mixed, promptly;
(4) preparation of coating cream group:
A, Oleum menthae add 375g rubber or modified rubber, add in 106g Colophonium or the modified rosin after making it softening again, and be standby;
B, the rubber mixing after 515g lithopone, chlorphenamine maleate, Pulvis Fellis Suis, above-mentioned gained mixing thick paste handled with a are smelt evenly fine and smooth, rubber-like coating cream group with open type rubber mixing machine or banbury;
C, in coating machine, b step gained coating cream group is evenly coated on elastical cloth or the painting cloth, is cut into the cream sheet again, promptly.Contain effective dose 2.5g in every emplastrum.
Embodiment 2
The preparation of pill
(1) takes by weighing Herba Pogostemonis 206g, Fructus Xanthii 257g, Herba Centipedae, 257g, Herba Ephedrae 129g, Flos Chrysanthemi Indici 129g, Radix Angelicae Sinensis 166g, Pulvis Fellis Suis 13g, Radix Scutellariae 109g, chlorphenamine maleate 1g, Oleum menthae 0.92g;
(2) arrangement of medical material: Herba Pogostemonis, Radix Angelicae Sinensis, Herba Ephedrae, Fructus Xanthii, Herba Centipedae, Flos Chrysanthemi Indici and Radix Scutellariae are removed impurity respectively, clean medical material;
(3) preparation of dried cream powder:
The preparation of A, dried cream powder
To add water with the multipotency extraction pot behind Herba Pogostemonis, Fructus Xanthii, Herba Centipedae, Flos Chrysanthemi Indici and the Herba Ephedrae wash, pressurization 0.1MPa decocts and extracts 2 times, and each 1 hour, extracting solution is concentrated, spray drying, powder gets dry extract;
The preparation of B, Radix Scutellariae dried cream powder
Radix scutellariae medicinal materials is washed the back add water with the multipotency extraction pot, pressurization 0.1MPa decocts and extracts 2 times, and each 1 hour, extracting solution concentrated, and spray drying gets the Radix Scutellariae dried cream powder;
The preparation of C, Radix Angelicae Sinensis dried cream powder
Radix Angelicae Sinensis is added 830g 60% ethanol, and continuous backflow is extracted secondary, and each 3 hours, extracting solution concentrated, and is spray dried to the Radix Angelicae Sinensis dried cream powder;
(4) preparation of mixed powder:
Get dried cream powder, Radix Scutellariae dried cream powder and Radix Angelicae Sinensis dried cream powder, add Pulvis Fellis Suis, chlorphenamine maleate, mixing promptly gets mixed powder;
(5) preparation of refined honey:
Get Mel 80g with jacketed pan heated and boiled to 110 ℃, while hot with the filtration of 80 mesh sieves, promptly;
(6) general ball:
It is even with the mixed of 1: 3 (weight ratio) to get refined honey and ethanol, a small amount of (4) mixed powder that makes is put into cylinder, start the pill cylinder, begin spray and add refined honey-alcohol mixeding liquid in a small amount, constantly be stirred to and make fine powder be moistening graininess, add an amount of mixed powder again, continuing to stir makes fine powder evenly overlay on the granule, spray adds refined honey-alcohol mixeding liquid and the fine powder of the mixed powder that Sa Jia above-mentioned (4) makes successively again, makes powder slowly add the tiny pill of great achievement with the method, crosses the sieve in 1mm aperture, the piller of getting the 1mm aperture sieve places the pill cylinder, continue to spray to add refined honey-alcohol mixeding liquid and spread to add fine powder, cross the sieve in 2mm-2.5mm aperture, get the piller that sieves and make the ball kind;
Add the ball kind in the pill cylinder, start the pill cylinder, spray adds the mixed liquor of an amount of refined honey-ethanol (1: 3), adds an amount of fine powder again after stirring makes the piller moistening, is the piller of 3.0mm～3.5mm size with the general ball of the method to diameter, sieves; Get the piller that sieves and drop in the pill cylinder, start pellet processing machine, more successively constantly spray add an amount of refined honey-ethanol (1: 2) mixed liquor and spread and add fine powder, pill is strengthened gradually, be 4.5mm～5.0mm size to the piller diameter till.Take out, sieve, the wet ball of getting ball footpath 4.5-5.0mm range size carries out drying;
(7) drying
To wet ball stand dish, drying, the ball embryo;
(8) coating
Place the pill cylinder to roll every cylinder ball embryo, and spray into Oleum menthae, stir evenly, take out, get coated pill with Sprayable.
Contain effective dose 0.13g in every coated pill.
Embodiment 3
The preparation of tablet
(1) takes by weighing Herba Pogostemonis 105g, Fructus Xanthii 500g, Herba Centipedae 130g, Herba Ephedrae 65g, Flos Chrysanthemi Indici 250g, Radix Angelicae Sinensis 90g, Pulvis Fellis Suis 26g, Radix Scutellariae 210g, chlorphenamine maleate 0.5g, Oleum menthae 0.5g;
(2) arrangement of medical material: Herba Pogostemonis, Radix Angelicae Sinensis, Herba Ephedrae, Fructus Xanthii, Herba Centipedae, Flos Chrysanthemi Indici and Radix Scutellariae are removed impurity respectively, clean medical material;
(3) preparation of dried cream powder:
The preparation of A, dried cream powder
To add water with the multipotency extraction pot behind Herba Pogostemonis, Fructus Xanthii, Herba Centipedae, Flos Chrysanthemi Indici and the Herba Ephedrae wash, pressurization 0.1MPa decocts and extracts 2 times, and each 1 hour, extracting solution is concentrated, spray drying, powder gets dry extract;
The preparation of B, Radix Scutellariae dried cream powder
Radix scutellariae medicinal materials is washed back multipotency extraction pot extracting in water 2 times, and pressurization 0.1MPa decocts, and each 1 hour, extracting solution concentrated, and spray drying gets the Radix Scutellariae dried cream powder;
The preparation of C, Radix Angelicae Sinensis dried cream powder
Radix Angelicae Sinensis is added 450g60% ethanol, and continuous backflow is extracted secondary, and each 3 hours, extracting solution concentrated, and is spray dried to the Radix Angelicae Sinensis dried cream powder;
(4) preparation of tablet: get dried cream powder, Radix Scutellariae dried cream powder and Radix Angelicae Sinensis dried cream powder, add Pulvis Fellis Suis, chlorphenamine maleate and Oleum menthae and starch and maltodextrin adjuvant, mixing, the system granule is pressed into lamellar, and coating promptly gets tablet.
Contain effective dose 1.3g in every tablet of tablet.
Embodiment 4
The preparation of capsule
(1) takes by weighing Herba Pogostemonis 600g, Fructus Xanthii 770g, Herba Centipedae 750g, Herba Ephedrae 380g, Flos Chrysanthemi Indici 380g, Radix Angelicae Sinensis 490g, Pulvis Fellis Suis 39g, Radix Scutellariae 320g, chlorphenamine maleate 3g, Oleum menthae 2.7g;
(2) arrangement of medical material: Herba Pogostemonis, Radix Angelicae Sinensis, Herba Ephedrae, Fructus Xanthii, Herba Centipedae, Flos Chrysanthemi Indici and Radix Scutellariae are removed impurity respectively, clean medical material;
(3) preparation of dried cream powder:
The preparation of A, dried cream powder
To add water with the multipotency extraction pot behind Herba Pogostemonis, Fructus Xanthii, Herba Centipedae, Flos Chrysanthemi Indici and the Herba Ephedrae wash, pressurization 0.1MPa decocts, extract 2 times, and each 1 hour, extracting solution is concentrated, spray drying, powder gets dry extract;
The preparation of B, Radix Scutellariae dried cream powder
Radix scutellariae medicinal materials is washed the back add water with the multipotency extraction pot, pressurization 0.1MPa decocts, and extracts 2 times, and each 1 hour, extracting solution concentrated, and spray drying gets the Radix Scutellariae dried cream powder;
The preparation of C, Radix Angelicae Sinensis dried cream powder
Radix Angelicae Sinensis is added 2450g 60% ethanol, and continuous backflow is extracted secondary, and each 3 hours, extracting solution concentrated, and is spray dried to the Radix Angelicae Sinensis dried cream powder;
(4) preparation of capsule: get dried cream powder, Radix Scutellariae dried cream powder and Radix Angelicae Sinensis dried cream powder, add Pulvis Fellis Suis, chlorphenamine maleate and Oleum menthae and an amount of pregelatinized Starch adjuvant, mixing, the system granule, filled capsules, promptly.
Contain effective dose 1.3g in every capsules.
Embodiment 5
The preparation of granule
(1) takes by weighing Herba Pogostemonis 70g, Fructus Xanthii 90g, Herba Centipedae 87g, Herba Ephedrae 45g, Flos Chrysanthemi Indici 45g, Radix Angelicae Sinensis 58g, Pulvis Fellis Suis 5g, Radix Scutellariae 40g, chlorphenamine maleate 0.3g, Oleum menthae 0.3g;
(2) arrangement of medical material: Herba Pogostemonis, Radix Angelicae Sinensis, Herba Ephedrae, Fructus Xanthii, Herba Centipedae, Flos Chrysanthemi Indici and Radix Scutellariae are removed impurity respectively, clean medical material;
(3) preparation of dried cream powder:
The preparation of A, dried cream powder
To add water with the multipotency extraction pot behind Herba Pogostemonis, Fructus Xanthii, Herba Centipedae, Flos Chrysanthemi Indici and the Herba Ephedrae wash, pressurization 0.1MPa decocts, extract 2 times, and each 1 hour, extracting solution is concentrated, spray drying, powder gets dry extract;
The preparation of B, Radix Scutellariae dried cream powder
Radix scutellariae medicinal materials is washed the back add water with the multipotency extraction pot, pressurization 0.1MPa decocts, and extracts 2 times, and each 1 hour, extracting solution concentrated, and spray drying gets the Radix Scutellariae dried cream powder;
The preparation of C, Radix Angelicae Sinensis dried cream powder
Radix Angelicae Sinensis is added 290g 60% ethanol, and continuous backflow is extracted secondary, and each 3 hours, extracting solution concentrated, and is spray dried to the Radix Angelicae Sinensis dried cream powder;
(4) preparation of granule: get dried cream powder, Radix Scutellariae dried cream powder and Radix Angelicae Sinensis dried cream powder, add Pulvis Fellis Suis, chlorphenamine maleate and Oleum menthae and an amount of pregelatinized Starch adjuvant, mixing is made granule, packing, promptly.
Contain effective dose 5g in every bag granule.
[test example 1]
Pharmaceutical composition of the present invention is to antiinflammatory and the effect of antiallergic pharmacology of rat
By rat granuloma inflammatory model experimental result as can be known, pharmaceutical composition of the present invention suppresses the granulomatous drug effect the best of rat, compare with the blank group, pharmaceutical composition of the present invention is low, in, high dose is respectively 37.2% to rat granuloma suppression ratio, 40.9%, 54.5%, has highly significant difference, its drug effect is better than the drug effect of pure Chinese medicine part of pharmaceutical composition of the present invention (removing the new pharmaceutical compositions that obtains behind the chlorphenamine maleate for pharmaceutical composition of the present invention) or chlorphenamine maleate, illustrate that pharmaceutical composition of the present invention pure division of traditional Chinese drugs branch compositions and chlorphenamine maleate synergy can obviously strengthen the granulomatous formation of inhibition rat, have tangible antiinflammatory action.By rat toes edema pharmacological model experimental result as can be known, pharmaceutical composition of the present invention obviously is better than pure Chinese medicine ingredients and chlorphenamine maleate, illustrate between pharmaceutical composition of the present invention pure division of traditional Chinese drugs branch compositions and the chlorphenamine maleate to have synergism, can strengthen antiinflammatory action.
By rat passive cutaneous anaphylaxis, PCA experimental result of the same race as can be known, pharmacological action the best of pharmaceutical composition of the present invention, obviously be better than using separately the pharmacological action of pure Chinese medicine ingredients in the pharmaceutical composition of the present invention or chlorphenamine maleate, compare with the blank group, pharmaceutical composition of the present invention is low, in, high dose group is respectively 27.1% to the suppression ratio that vascular permeability due to injection sensitization rat blood serum (dilution factor is 1: 10) increases, 35.0%, 44.2%, the suppression ratio that vascular permeability due to injection sensitization rat blood serum (dilution factor is 1: 20) is increased is respectively 22.6%, 29.6%, 39.3%, illustrate that pharmaceutical composition of the present invention pure division of traditional Chinese drugs branch compositions and chlorphenamine maleate can strengthen the allergic effect of pharmaceutical composition anti-I type of the present invention.
Cause the rat skin permeability by histamine and increase the model experiment result as can be known, the pharmacological action of pharmaceutical composition of the present invention is the strongest, compare with the blank group, it is low, in, high dose is respectively 20.0% to the suppression ratio that capillary permeability due to the histamine increases, 24.7%, 30.5%, has significant differences, obviously be better than single with the pure Chinese medicine ingredients in the pharmaceutical composition of the present invention or single chlorphenamine maleate of using, Chinese medicine ingredients and chlorphenamine maleate that pharmaceutical composition of the present invention is described have synergism, therefore the permeability that can obviously suppress rat skin due to the histamine has good anti-allergic effects.
Be subjected to the reagent thing
Pharmaceutical composition of the present invention; Chlorphenamine maleate, lot number: SC/IX/4922, by KongoChemical Co., Ltd. produces, the pure Chinese medicine part of pharmaceutical composition of the present invention; Above sample is provided by Foshan Dezhong Pharmaceutical Co., Ltd..
Compound method:
Be subjected to the reagent thing through grinding, be mixed with suspension with 0.5% sodium carboxymethyl cellulose (CMC-Na) solution.
Laboratory animal:
SD is a rat, the laboratory animal quality certification number: 99A032 is provided by Guangdong Medical Lab Animal Center.
Body weight: 150 ± 15g
Sex:
Experiment 1: male, adopt randomized, 8 every group during grouping.Number of animals: 208.
Experiment 2: male female half and half, adopt randomized, 8 every group during grouping.Number of animals: 218.
Experiment 3: male female half and half, adopt randomized, 8 every group during grouping.Number of animals: 104.
Experiment 4: male female half and half, adopt randomized, 8 every group during grouping.Number of animals: 106.
Test procedure:
Experiment 1: selecting healthy male SD is rat, and 104, etherization cuts off back wool.Make a transverse incision behind iodine tincture and the alcohol disinfecting; the about 16mm of diameter; (used plastic hoop is the igelite centrifuge tube to this otch less than the plastic hoop edge; be cut into external diameter 15mm; internal diameter 14mm, edge 2mm, the open shape that is high about 7mm is encircled; before the experiment it is boiled 20min; so that sterilization and anti-deformation), with the edge embedded otch of disinfectant plastic hoop, last at skin closure two pins near the plastic hoop edge; with slip-off preventing; 4000u/ of operation intramuscular injection on same day penicillin, wound need not protection, and animal divides cage to raise separately; post-operative wound has liquid to ooze out and very fast incrustation; be divided into 13 groups at random, 8 every group, the difference gastric infusion; successive administration 15 days was put to death rat after 15 days.Ring is taken off, isolate granulation tissue, blot liquid with filter paper, blood crusts on the granulation and muscular fasciae are also divided only, 60 ℃ of baking box oven dry are weighed, and represent with the mg/100g body weight.
Experiment 2: selecting healthy SD is male rat, 150 ± 15g body weight, 104, be divided into 13 groups at random, the difference gastric infusion, simultaneously to the proinflammatory agent (temperature is bathed in 38 ℃ of water-baths before 1% agar, administration) of its right hind foot plantar subcutaneous injection 0.1ml, inject behind the proinflammatory agent 0,0.5,1,2,4,6h measures the rat paw volume with the capillary tube volumetric method respectively.
Experiment 3: Antiserum Preparation: ovalbumin is through Na
2SO
4Recrystallization 3 times is prepared into ovalbumin 80mg, is made into 2mg/ml solution with 4% gel aluminum hydroxide, gets body weight 90～100g healthy SD rat, and male and female half and half, are given rat intramuscular injection ovalbumin 10mg/Kg body weight respectively, simultaneously lumbar injection 2*10 by totally 8
10/ bordetella pertussis.After the sensitization 10 days, put to death the animal blood sampling, 1000rpm*5min is centrifugal, separates and combining anteserum, and it is standby to put refrigerator.
Passive sensitization of skin and antigen are attacked, and other gets 150 ± 15g body weight rat, and 104, under the etherization, cut off back wool, with the antiserum (dilution factor can be at 1: 20,1: 10) of dilution, intradermal injection is in the Mus back, and each dilution factor is injected 2 points, every some 0.1ml.Be divided into 13 groups at random, every group 8, it is the basic, normal, high dosage group of blank group, pharmaceutical composition of the present invention, the pure division of traditional Chinese drugs of pharmaceutical composition of the present invention divides compositions basic, normal, high dosage group, the basic, normal, high dosage group of chlorphenamine maleate, the basic, normal, high dosage group of hismanal dosage group is carried out antigen and is attacked behind the successive administration 2d, intravenous injection 1ml 0.5% azovan blue solution includes egg protein 1mg.Sacrificed by decapitation animal behind the 20min, the upset skin of back is cut locus coeruleus skin, and (3: 7=v/v) soak 48h, 1000rpm*5min is centrifugal, gets supernatant and measures optical density with 590nm with 5ml acetone normal saline solution for every some skin.
Experiment 4: rat back is shaved hair, area is 3*3cm, be divided into 13 groups at random, every group 8, it is the blank group, pharmaceutical composition of the present invention is low, in, high dose group, the pure division of traditional Chinese drugs of pharmaceutical composition of the present invention divides compositions low, in, high dose group, chlorphenamine maleate is low, in, high dose group, hismanal dosage group, after each organizes rat administration 30min, the histamine 0.5ml/kg body weight of intradermal injection 1 μ g/ml, every rat back is injected 2 points altogether, sublingual vein is annotated 1% azovan blue 5ml/kg immediately, broken end sacrificed by exsanguination rat behind the 15min, the strip off skin of back is measured injection site Intradermal stained area, or the skin that rat back is painted is cut, chopping is put into water-acetone soln (3: 7 volume ratios) and is soaked 48h, and 1000rpm*5min is centrifugal, get supernatant, spectrophotometer 590nm colorimetric.
Observing time:
Measure after 15 days after testing 1. administrations.
Test after 2. administrations and the injection proinflammatory agent carries out simultaneously, inject behind the proinflammatory agent 0,0.5,1,2,4,6h measures the rat paw volume with the capillary tube volumetric method respectively.
Testing 3. administrations measured after 2 days.
Inject histamine after testing 4. administration 30min, measure behind the 15min.
Dosage is provided with
It is low that pharmaceutical composition of the present invention is set, in, high dose group, the pure division of traditional Chinese drugs of pharmaceutical composition of the present invention divides compositions low, in, high dose group, chlorphenamine maleate is low, in, high dose group, pharmaceutical composition of the present invention is low, in, high dosage is respectively 0.364,1.092,2.184g/Kg body weight, the pure division of traditional Chinese drugs of pharmaceutical composition of the present invention divides compositions low, in, high dosage is respectively 0.363,1.089,2.178g/Kg body weight, chlorphenamine maleate is low, in, high dosage is respectively 1,3, the 6mg/Kg body weight is equivalent to 1 of 70Kg adult's consumption every day, 3,6 times.
The continuous respectively gastric infusion of experiment 1. experimentized after 15 days.
Experimentize at once after testing 2. gastric infusions.
The continuous respectively gastric infusion of experiment 3. experimentized after 2 days.
Experimentize after testing 4. gastric infusion 30min.
Experimental control
The blank group gavages equal-volume 0.5%CMC-Na solution.
Experiment 1,2: positive control drug adopts Aspirin Enteric-coated Tablets, and Hunan pharmaceutical factory produces, and the accurate word (1989) of medicine is defended No. 001157 in Hunan, lot number 990907-4.Dosage is 161mg/kg, is equivalent to 1 times of 70Kg adult's consumption every day, is made into suspension with 0.5%CMC-Na solution during use.Select foundation for use: Aspirin Enteric-coated Tablets is analgesic, anti-inflammatory analgesic, is used for analgesia, analgesic, antiinflammatory, rheumatism, scorching joint inflammation etc., is anti-inflammatory drug more satisfactory, exact efficacy.
Experiment 3,4: positive control drug adopts hismanal, according to being that hismanal cures mainly long-term property and seasonal allergic rhinitis and skin allergy, anaphylaxis conjunctivitis, chronic urticaria and other anaphylactic reaction symptom and sign there are definite curative effect, conform to the indication of this medicine.Positive dosage is 0.89mg/kg, is equivalent to 1 times of 70Kg adult's consumption every day.
Result of the test:
Table 1 pharmaceutical composition of the present invention to the research of rat granuloma model (X ± SD, n=8)
| Group | The aspirin group | The blank group | Pharmaceutical composition low dose group of the present invention | Dosage group in the pharmaceutical composition of the present invention | Pharmaceutical composition high dose group of the present invention | The pure Chinese medicine ingredients low dose group of pharmaceutical composition of the present invention |
| Granuloma (mg/100g) (suppression ratio) | 162.4± 38.5 **(32.4) | 240.3±53.4(--) | 151.0±49.3 **(37.2) | 141.9± 52.6 ***(40.9) | 109.3±60.0 ***(54.5) | 197.6±43.1 △(17.8) |
| Group | Dosage group in the pure Chinese medicine ingredients of pharmaceutical composition of the present invention | The pure Chinese medicine ingredients high dose group of pharmaceutical composition of the present invention | The chlorphenamine maleate low dose group | Dosage group in the chlorphenamine maleate | The chlorphenamine maleate high dose group | |
| Granuloma (mg/100g) (suppression ratio) | 217.7±51.0 △(94) | 181.8±37.9 *(24.3) | 176.8±29.3 (26.4) | 157.1± 35.6 **(34.6) | 151.1±68.5 *(37.1) |
Compare with the blank group,
△P＞0.05,
*P＜0.05,
*P＜0.01,
* *P＜0.001
By rat granuloma model experimental result as can be known, pharmaceutical composition of the present invention, the pure division of traditional Chinese drugs of pharmaceutical composition of the present invention divides compositions, chlorphenamine maleate all has and suppresses the granulomatous formation of rat in various degree, analyze from drug effect, pharmaceutical composition of the present invention suppresses the granulomatous drug effect the best of rat, compare with the blank group, pharmaceutical composition of the present invention is low, in, high dose is respectively 37.2% to rat granuloma suppression ratio, 40.9%, 54.5%, has significant differences, its drug effect is better than independent pharmaceutical composition of the present invention pure division of traditional Chinese drugs branch compositions or chlorphenamine maleate, illustrate that pharmaceutical composition of the present invention pure division of traditional Chinese drugs branch compositions and chlorphenamine maleate synergy can obviously strengthen the granulomatous formation of inhibition rat, have tangible antiinflammatory action.
Table 2 pharmaceutical composition of the present invention is to the pharmacological research of rat toes edema model (x ± SD, n=8)
| Administration | Rat toes edema volume (ml) (the swelling rate, %) | ||||||
| 0h | 0.5h | 1h | 2h | 4h | 6h | ||
| The blank group | 0.67±0.13 | 1.3±0.27(93.7) | 1.62±0.24 (140.8) | 1.47±0.06 (118.6) | 1.28±0.08 (90.1) | 1.14±0.08 (69.8) | |
| Pharmaceutical composition low dosage of the present invention | 0.70±0.10△ | 0.91±0.09 (29.2) ** | 1.13±0.09 (61.2) *** | 1.04±0.11 (48.4) *** | 0.92±0.09 (30.6) *** | 0.79±0.09 (12.8) *** | |
| Dosage in the pharmaceutical composition of the present invention | 0.58±0.09△ | 0.74±0.12 (27.7) ** | 0.84±0.10 (44.1) *** | 0.85±0.06 (46.6) *** | 0.76±0.10 (30.9) *** | 0.68±0.08 (16.9) | |
| Pharmaceutical composition high dose of the present invention | 0.560±0.10△ | 0.69±0.07 (24.0) ** | 0.80±0.06 (43.2) *** | 0.76±0.06 (36.0) *** | 0.71±0.03 (26.7) *** | 0.66±0.09 (18.8) *** | |
| The pure Chinese medicine ingredients low dosage of pharmaceutical composition of the present invention | 0.70±0.09△ | 1.18±0.13 (69.0) ** | 1.32±0.15 (88.8) *** | 1.31±0.09 (87.5) *** | 1.1±0.10 (57.0) *** | 0.92±0.06 (31.3) *** | |
| The pure division of traditional Chinese drugs of pharmaceutical composition of the present invention divides dosage in the compositions | 0.64±0.08△ | 0.97±0.15 (5.13) ** | 1.01±0.23 (58.5) ** | 0.94±0.16 (47.5) *** | 0.85±0.10 (33.5) *** | 0.81±0.08 (25.9) *** | |
| The pure Chinese medicine ingredients high dose of pharmaceutical composition of the present invention | 0.75±0.05△ | 0.95±0.10 (27.5) * | 1.14±0.09 (53.0) ** | 1.04±0.05 (39.3) *** | 0.93±0.04 (24.3) ** | 0.86±0.04 (16.0) *** | |
| The chlorphenamine maleate low dosage | 0.72±0.07△ | 1.18±0.11 (63.2) △ | 1.50±0.19 (108.5) △ | 1.39±0.21 (92.7) △ | 1.31±0.30 (81.3) △ | 1.06±0.19 (47.7) △ | |
| Dosage in the chlorphenamine maleate | 0.63±0.09△ | 1.06±0.18 (68.6) △ | 1.25±0.13 (98.9) ** | 1.23±0.15 (95.2) *** | 1.04±0.11 (65.9) *** | 0.89±0.08 (40.9) *** | |
| The chlorphenamine maleate high dose | 0.57±0.09△ | 0.76±0.08 (34.8) *** | 0.92±0.08 (62.4) *** | 0.93±0.08 (64.9) *** | 0.84±0.07 (47.7) *** | 0.74±0.07 (30.8) *** | |
| The aspirin group | 0.78±0.07△ | 1.13±0.15 (44.3) △ | 1.26±0.1 60.3) ** | 1.12±0.10 (43.2) *** | 1.04±0.1(33.0) *** | 0.95±0.10 (21.2) *** | |
Compare with the blank group,
△P＞0.05,
*P＜0.01,
* *P＜0.001.
By rat toes edema pharmacological model experimental result as can be known, agar is middle effect proinflammatory agent, 1h behind the injection proinflammatory agent, rat toes edema reaches summit, and pharmaceutical composition of the present invention, the pure division of traditional Chinese drugs branch of pharmaceutical composition of the present invention compositions, chlorphenamine maleate all have and suppress agar in various degree and cause the swelling of rat toes.Pharmaceutical composition of the present invention suppresses agar and causes that the effect of rat toes swelling is all good than the effect of chlorphenamine maleate, the pure Chinese medicine part of pharmaceutical composition of the present invention.
Table 3 pharmaceutical composition of the present invention to the research of rat passive cutaneous anaphylaxis, PCA of the same race (X ± SD, n=8)
| Group | The blank group | Pharmaceutical composition low dosage of the present invention | Dosage in the pharmaceutical composition of the present invention | Pharmaceutical composition high dose of the present invention | The pure Chinese medicine ingredients low dosage of pharmaceutical composition of the present invention | Dosage in the pure Chinese medicine ingredients of pharmaceutical composition of the present invention |
| Absorbance A 590mSerum dilution 1: 10,1: 20 (suppression ratio, %) | 0.254±0.033(--) 0.126±0.048(--) | 0.185±0.029 (27.1) ***0.098± 0.024(22.6) * | 0.165±0.31(35.0) ***0.089±0.011(29.6) ** | 0.142±0.028 (44.2) ***0.077± 0.020(39.3) *** | 0.236±0.038 (7.2) △0.096± 0.039(24.2) * | 0.207±0.050 (18.4) ***0.089± 0.023(29.8) ** |
| Group | The pure Chinese medicine ingredients high dose of pharmaceutical composition of the present invention | The chlorphenamine maleate low dosage | Dosage in the chlorphenamine maleate | The chlorphenamine maleate high dose | The hismanal group | |
| Absorbance A 590mSerum dilution 1: 10,1: 20 (suppression ratio, %) | 0.192±0.051 (24.5) ***0.086± 0.018(32.1) ** | 0.226±0.051 (10.9) △0.092± 0.012(22.2) ** | 0.192±0.051(24.5) ***0.092±0.023(27.2) ** | 0.163±0.042 (35.9) ***0.087± 0.027(30.8) ** | 0.196±0.016 (22.9) *0.098± 0.022(22.6) * |
Compare with the blank group,
△P＞0.05,
*P＜0.05,
*P＜0.01,
* *P＜0.001.
In the normal rat back, every forms a skin mound with serum (the including abundant IgE antibody) intradermal injection of sensitization rat.The Fc receptors bind of IgE and local skin mastocyte makes it passive sensitization.When antigen is attacked, cause that local mastocyte discharged sensitive media, thereby the permeability of local vascular is increased, inject azovan blue, can ooze out in Pi Qiunei, form a locus coeruleus.According to locus coeruleus scope or depth degree, judge that vascular permeability changes, with the degree of reflection skin allergy.By rat passive cutaneous anaphylaxis, PCA of the same race (Rat homologous passiVe Cutaneous Anaphylaxis, RatPCA) experimental result as can be known, pharmaceutical composition each component of the present invention all has and suppresses sensitization rat IgE in various degree and mediate local mastocyte and discharged sensitive media, pharmacological action the best of pharmaceutical composition of the present invention wherein, obviously be better than using separately the pharmacological action of pure Chinese medicine ingredients in the pharmaceutical composition of the present invention or chlorphenamine maleate, compare with the blank group, pharmaceutical composition of the present invention is low, in, high dose group is respectively 27.1% to the suppression ratio that vascular permeability due to injection sensitization rat blood serum (dilution factor is 1: 10) increases, 35.0%, 44.2%, the suppression ratio that vascular permeability due to injection sensitization rat blood serum (dilution factor is 1: 20) is increased is respectively 22.6%, 29.6%, 39.3%, illustrate that pharmaceutical composition of the present invention pure division of traditional Chinese drugs branch compositions and chlorphenamine maleate have synergism, can strengthen the allergic effect of pharmaceutical composition anti-I type of the present invention.
Table 4 pharmaceutical composition of the present invention to histamine cause the rat skin permeability increase Study of model (X ± SD, n=16)
| Group | The blank group | Pharmaceutical composition low dosage of the present invention | Dosage in the pharmaceutical composition of the present invention | Pharmaceutical composition high dose of the present invention | The pure Chinese medicine ingredients of pharmaceutical composition of the present invention is low | Dosage in the pure Chinese medicine ingredients of pharmaceutical composition of the present invention |
| Absorbance A 590m(suppression ratio, %) | 0.221±0.043(---) | 0.175±0.022(20.0) *** | 0.166±0.029 (24.7) *** | 0.154±0.035 (30.5) *** | 0.188±0.036 (14.8) * | 0.179±0.024 (19.2) ** |
| Group | The pure Chinese medicine ingredients high dose of pharmaceutical composition of the present invention | The chlorphenamine maleate low dosage | Dosage in the chlorphenamine maleate | The chlorphenamine maleate high dose | The hismanal group | |
| Absorbance A 590m(suppression ratio, %) | 0.174±0.024 (21.4) ** | 0.186±0.022 (15.7) ** | 0.177±0.034 (19.7) ** | 0.166±0.028 (25.0) *** | 0.186±0.029 (16.1) ** |
Compare with the blank group,
*P＜0.05,
*P＜0.01,
* *P＜0.001.
Histamine is chemical mediator commonly used, uses so that the scorching acute inflammatory reaction that produces, and makes plasma protein penetrate extravascular tissue speed and accelerates, be i.e. capillary permeability increase.After vein injects azovan blue, present and dye indigo plant causing scorching position.Reflect the antiinflammatory action that is tried thing according to its acetone normal saline leachate absorbance.Causing the rat skin permeability by histamine increases the model experiment result as can be known, all had by the reagent thing and suppresses the effect that histamine causes the increase of rat skin permeability in various degree.The pharmacological action that the rat skin permeability increases due to the pharmaceutical composition antihistamine of the present invention is the strongest, compare with the blank group, pharmaceutical composition of the present invention is low, in, high dose is respectively 20.0% to the suppression ratio that capillary permeability due to the histamine increases, 24.7%, 30.5%, has significant differences, obviously be better than single with the pure Chinese medicine ingredients in the pharmaceutical composition of the present invention or single chlorphenamine maleate of using, illustrate that pharmaceutical composition of the present invention pure division of traditional Chinese drugs branch compositions and chlorphenamine maleate have synergism, therefore the permeability that can obviously suppress rat skin due to the histamine has good antiinflammatory action.
Conclusion (of pressure testing)
Pharmaceutical composition of the present invention pure division of traditional Chinese drugs branch compositions and chlorphenamine maleate synergy can obviously strengthen the pharmacological action that suppresses the formation of rat granuloma, suppress agar and cause the swelling of rat toes, illustrate that pharmaceutical composition of the present invention has tangible antiinflammatory action.
Pharmaceutical composition of the present invention has anti-passive cutaneous anaphylaxis, PCA (PCA) effect, and pharmaceutical composition of the present invention pure division of traditional Chinese drugs branch compositions and chlorphenamine maleate have synergism, can strengthen the allergic effect of pharmaceutical composition anti-I type of the present invention.
The pure division of traditional Chinese drugs of pharmaceutical composition of the present invention divides compositions and chlorphenamine maleate synergy, can obviously suppress the permeability of rat skin due to the histamine, has good anti-allergic effects.
[test example 2]
The clinical efficacy of pharmaceutical composition of the present invention and safety testing thereof
Jointly carry out III clinical trial phase in five tame hospitals such as The First Affiliated Hospital of Guangzhou University of Traditional Chinese Med, No.2 Hospital Attached to Guangzhou Traditional Chinese Medicial Univ, first Affiliated Hospital of Zhongshan Medical Univ., Guangzhou medical science second Affiliated Hospital, Guangzhou institutes of traditional Chinese medicine year March in June, 1999 to 2000, finish 479 routine clinical observation cases altogether, medication therapy groups 300 examples (acute rhinitis 107 examples wherein of the present invention, chronic rhinitis 94 examples, allergic rhinitis 99 examples), QIANBAI BIYAN PIAN and hismanal matched group be totally 179 examples (acute rhinitis 53 examples, chronic rhinitis 66 examples, allergic rhinitis 60 examples).
Single blind randomized controlled trial method is adopted in this research, confirms that medication therapy groups of the present invention is 42.99% to wind and heat in the lung meridian type acute rhinitis obvious effective rate, and total effective rate is 92.52%, is better than QIANBAI BIYAN PIAN matched group (P＜0.01; To lung meridian intrinsic heat, the evil nose key type chronic rhinitis obvious effective rate that stagnates is 57.45%, and total effective rate is 97.88%, to QIANBAI BIYAN PIAN matched group general curative effect similar substantially (P＞0.05), but the improvement of cardinal symptom nasal obstruction is better than matched group; To lung meridian intrinsic heat type allergic rhinitis obvious effective rate is 33.33%, and total effective rate is 84.85%, similar to the hismanal matched group (P＞0.05), and the improvement of nasal cavity sign (nasal mucosa swelling) is better than matched group.
That a few patients can occur in the medication process is slightly drowsiness, asthenia, dizziness, feel sick, reaction such as stomachache, so unsuitable steering vehicle, handle machine and work high above the ground etc. during the medication.Taking medicine did not continuously have obvious damage to important organs such as blood system and the heart, liver, kidneys in 4 weeks.
Originally studies confirm that pharmaceutical composition of the present invention is a kind of acute or chronic rhinitis and effective and safer Chinese medicine preparation of allergic rhinitis for the treatment of.
Disease kind and case load following (table) that each hospital is observed:
The disease kind that each hospital of table 5 is observed has case load
| Hospital name | The sick kind | Case load | The treatment group | Matched group |
| No.2 Hospital Attached to Guangzhou Traditional Chinese Medicial Univ No.2 Hospital Attached to Guangzhou Traditional Chinese Medicial Univ Guangzhou Zhongshan Medical Univ. of institute of traditional Chinese medicine of The First Affiliated Hospital of Guangzhou University of Traditional Chinese Med first affiliated hospital's The First Affiliated Hospital of Kunming Medical School | Acute rhinitis acute rhinitis chronic rhinitis chronic rhinitis allergic rhinitis allergic rhinitis | 80 80 80 80 80 79 | 51 56 44 50 50 49 | 29 24 36 30 30 30 |
| Add up to | 479 | 300 | 179 |
Object and method
The choice criteria of study subject
(1) acute rhinitis
Local symptom (indispensability): nasal obstruction, watery nasal discharge (clear rare or sticking accent), sneeze, hyposmia; General Symptoms: general malaises such as heating, headache, pharyngalgia, cough can be arranged; Check: nasal mucosa hyperemia, swelling, secretions increase; The course of disease is in 1 week.
The Chinese medical discrimination standard:
1) rhinocnesmus; 2) burning sensation; 3) sneeze; 4) nasal obstruction; 5) nasal mucus is sticking yellow; 6) nasal cavity inspection: nasal mucosa hyperemia, swelling; 7) the thick Huang of nasal secretion; 8) heating; 9) micro evil wind, 10) headache; 11) xerostomia; 12) cough; 13) pharyngalgia; 14) expectorant is sticking; Tongue 15) matter is red, and 16) white and thin fur or BOHUANG; 17) floating and rapid pulse.
More than 1), 2) two indispensabilities, all the other four possess plural Sx and get final product.
Include standard in:
Meet above diagnostic criteria and Chinese medical discrimination standard, the morbidity 72 hours with interior person, include the test case in.
Exclusion standard:
1) age is below 10 years old or the over-65s person;
2) gestation or women breast-feeding their children, allergic constitution or to this medicine allergy sufferers;
3) specificity inflammation causers such as influenza, measles, scarlet fever, chickenpox;
4) merge patients such as tracheitis, bronchitis, sinusitis;
5) be associated with serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system and psychotic;
6) do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data is not congruent affects the treatment or safety judgement person.
(2) chronic rhinitis
Diagnostic criteria: regular nasal obstruction, be intermittent, alternately property outbreak, night, flat when crouching or sitting quietly nasal obstruction increase the weight of, its downside nasal obstruction increases the weight of when lying on one's side; Often with symptoms such as watery nasal discharge, distending pain in the heads, or hyposmia; Check: the hyperemia of bilateral concha nasalis inferior, swelling, smooth surface, mucosa is soft and flexible, and is good to vasoconstrictor response; The course of disease is more than 1 month.
The Chinese medical discrimination standard:
With the passing of time 4 nasal obstructions are intermittent or alternately property, outbreak repeatedly;
5 nasal cavity inspections: two concha nasalis inferior hyperemia, swelling, smooth surface, good to vasoconstrictor response;
6 nose Qiao Gan inflammation burning sensations, nasal mucus is sticking yellow;
7 xerostomias, cough expectorant Huang, pharyngalgia;
8 red tongue, white and thin fur or BOHUANG;
9 rapid pulse.
More than 1,2 two indispensability, all the other four possess plural Sx and get final product.
Include standard in:
Meet above diagnostic criteria and Chinese medical discrimination standard person simultaneously, include the test case in.
Exclusion standard:
1) age is below 10 years old or the over-65s person;
2) gestation or women breast-feeding their children, allergic constitution or to this medicine allergy sufferers;
3) chronic hypertrophic rhinitis, hypertrophic inferior turbinate is to ephedrine poor response person;
4) merge patients such as tracheitis, bronchitis, sinusitis;
5) be associated with serious primary disease such as cardiovascular, cerebrovascular, liver, kidney and hemopoietic system and psychotic;
6) do not meet the standard of including in, not medication in accordance with regulations can't be judged curative effect, or data is not congruent affects the treatment or safety judgement person
(3) allergic rhinitis
Diagnostic criteria:
The perennial allergic rhinitis
A, the condition of keeping the score; 1. perennial onset has sneeze (each continuous more than 3), snivel and three main clinical manifestation of nasal mucosa swelling, and morbidity number of days accumulative total surpasses 6 months in 1 year, and disease time accumulative total was above 0.5 hour in one day; 2. the course of disease is at least one year.
B, the standard of keeping the score: clear and definite inhalation (inhalatio) sensitinogen clue is arranged, a guy and/or family's anaphylactic disease history,, there are typical symptoms and sign stage of attack, and each remembers 1 fen, totally 3 minutes.The positive reaction of allergen tuerculoderma has at least a kind of for (++) or more than (++); Specific IgE antibody detects the positive or the allergen nasal provocation test positive, and meets with tuerculoderma and medical history, each gets totally 4 minutes 2 fens.The nasal smear inspection eosinophilic granulocyte positive and/or nasal mucosa scraping blade mastocyte (basophil) are positive to be got 1 fen.
The score 6-8 person of branch is diagnosed as the perennial allergic rhinitis.
Pollinosis
1. seasonal morbidity, annual morbidity season basically identical, and be consistent with sensitization pollen pollinating period; At least two years in same morbidity in season.
2., there are typical clinical symptoms and sign stage of attack.
3. stage of attack nasal discharge (and/or conjunctiva scraping blade) the eosinophilic granulocyte positive, or nasal mucosa scraping blade mastocyte (basophil granule born of the same parents) positive.
4. the pollen allergen tuerculoderma is positive, and at least a is (++) or more than (++), or the allergen nasal provocation test positive, the eye conjunctival butter positive.
The Chinese medical discrimination standard
1 paroxysmal break out nasal obstruction, rhinocnesmus, sneeze, snivel;
2 nasal mucosas are red slightly or dark red, swelling;
3 red tongue, yellow fur, rapid pulse;
4 are everlasting extremely hot hot summer days or lured and sent out by steam, cough expectorant Huang, and itching throat Er Gan inflammation, thirsty, yellowish urine.
Dialectical standard: 1)+2)+3), or 1)+2)+4) in the symptom that (contains two) more than two.
Include standard in
Meet the diagnostic criteria of perennial allergic rhinitis or pollinosis and the dialectical standard person of allergic rhinitis lung meridian intrinsic heat type, include this group subjects in.
Exclusion standard
1) age is the child below 10 years old, gestation or women breast-feeding their children;
2) leave protopathy place and environment person during the treatment;
3) merge acute rhinitis or sinusitis person;
4) merge cardiovascular and cerebrovascular disease, liver, kidney or disease in the blood system and insane;
5), or do not take medicine in accordance with regulations and can not accept check person to this medicine allergy.
Therapeutic Method
1, acute rhinitis
Treatment group (1 group): rhinitis tablet I number (pharmaceutical composition of the present invention), oral, each 4, every day 3 times, serve on 5 days.
Matched group (2 groups): rhinitis tablet II number (QIANBAI BIYAN PIAN), oral, each 4, every day 3 times, serve on 5 days.
Viewing duration all no longer adds with other medicine or treatment means for two groups.
2, chronic rhinitis
Treatment group (1 group): rhinitis tablet I number, oral, each 4, every day 3 times, serve on for 4 weeks.
Matched group (2 groups): rhinitis tablet II number, oral, each 4, every day 3 times, serve on for 4 weeks.
Viewing duration all no longer adds with other medicine or treatment means for two groups.
3, allergic rhinitis
Treatment group (1 group): rhinitis tablet I number, oral, each 4, every day 3 times, serve on for 4 weeks.
Matched group (2 groups); Rhinitis tablet III number (hismanal), oral, each 1, every day 1 time, serve on for 4 weeks.
Viewing duration all no longer adds with other medicine or treatment means for two groups.
Curative effect judging standard
(1) acute rhinitis
According to " the clinical research guideline of new Chinese medicine treatment cold nasal obstruction ", curative effect determinate standard is as follows;
2 clinical recoveries: sx in the medication 3 days, symptom and sign disappear in 5 days.
3 produce effects: sx in the medication 3 days, 2/3 symptom and sign disappear in 5 days.
4 is effective; Sx in the medication 3 days, 1/3 symptom and sign disappear in 5 days.
5 is invalid: do not reach effective standard.
(2) chronic rhinitis
Difference and the ratio for the treatment of preceding total mark according to the total mark of 10 cardinal symptoms such as nasal obstruction, watery nasal discharge, hyposmia, headache, xerostomia, cough, pharyngalgia, nasal mucosa hyperemia, nasal mucosa swelling, nasal secretion and sign before and after taking medicine, determine the curative effect determinate standard of this research, that is:
Score value 〉=51% is a produce effects, and 50-21% is that effectively≤20% is invalid.
(3) allergic rhinitis
According to " the diagnosis of allergic rhinitis standard and the efficacy assessment standard " of otolaryngology branch of Chinese Medical Association 1997 revision, promptly on the basis that symptom and sign classification are kept the score, evaluate:
Score value 〉=51% is a produce effects, and 50～21% is that effectively≤20% is invalid.
Statistical analysis
After observing end, all case histories input computers carry out data analysis with the SPSS statistical package and handle, and enumeration data adopts chi-square analysis, and two means relatively adopt the t check.
Curative effect relatively
(1) acute rhinitis
1, two groups of total effectses relatively
Two groups of total effectses of table 6 acute rhinitis are [example (%)] relatively
| Group | The example number | Produce effects | Effectively | Invalid | Total effective rate |
| Treatment group matched group | 107 53 | 46(42.99) 11(20.76) | 53(49.53) 31(58.49) | 8(7.48) 11(20.75) | 99(92.52) 42(79.25) |
x
2＝10.72，P＜0.01
As shown in table 6, treatment group obvious effective rate 42.99%, total effective rate 92.52%; Matched group obvious effective rate 20.76%, total effective rate 79.25%.Two groups relatively, and significant difference (P＜0.01) is arranged, and illustrates that treatment group general curative effect is better than matched group.
2, cardinal symptom and sign improvement situation are relatively
1) treatment cardinal symptom and sign comparison after 3 days
Treat after 3 days, treatment is organized among the patient of 17 examples with heating and is still had 5 example heatings, and matched group 11 examples occur together still has 4 example heatings among the patient of heat, and two groups relatively, there was no significant difference (P＞0.05).All the other symptoms and sign relatively see Table 7.
Table 7 acute rhinitis treatment cardinal symptom and the comparison of sign integration after 3 days (x ± s)
| Sx | The treatment group | Matched group | The t value | The P value |
| Integration | Integration | |||
| The congested schneiderian membrane swelling of nasal obstruction runny nose headache hyposphresia dry cough pharyngalgia schneiderian membrane nasal secretion | 1.33±0.50 1.20±0.54 0.38±0.62 0.29±0.54 0.50±0.56 0.45±0.50 0.21±0.46 1.30±0.48 1.25±0.53 1.16±0.55 | 1.48±0.64 1.38±0.60 0.55±0.61 0.51±0.67 0.62±0.60 0.32±0.47 0.28±0.53 1.47±0.61 1.49±0.67 1.23±0.61 | 1.62 1.91 1.64 2.24 1.25 1.58 0.86 1.92 2.46 0.73 | ＞0.05 ＞0.05 ＞0.05 ＜0.05 ＞0.05 ＞0.05 ＞0.05 ＞0.05 ＜0.05 ＞0.05 |
As shown in table 7, treat the integrated value of hyposmia and nasal mucosa swelling after 3 days, the treatment group is starkly lower than matched group (P＜0.05), illustrates that the treatment group is obvious than matched group to the improvement of these two symptoms (sign).
2) treatment cardinal symptom and sign comparison after 5 days
Treating after 5 days two groups does not all have the febrile disease example, all the other symptoms and sign relatively see Table 8.
Table 8 acute rhinitis treatment two groups of cardinal symptoms and the comparison of sign integration after 5 days (x ± s)
| Sx | The treatment group | Matched group | The t value | The P value |
| Integration | Integration | |||
| The congested schneiderian membrane swelling of nasal obstruction runny nose headache hyposphresia dry cough pharyngalgia schneiderian membrane nasal secretion | 0.55±0.71 0.37±0.63 0.10±0.33 0.07±0.25 0.16±0.37 0.07±0.25 0.07±0.26 0.56±0.60 0.57±0.74 0.36±0.56 | 0.870.70 0.68±0.61 0.15±0.36 0.32±0.51 0.32±0.51 0.15±0.36 0.14±0.35 1.00±0.71 0.89±0.72 0.62±0.60 | 2.7 2.96 1.05 4.17 2.26 1.64 1.42 4.1 2.6 2.7 | ＜0.01 ＜0.01 ＞0.05 ＜0.01 ＜0.05 ＞0.05 ＞0.05 ＜0.01 ＜0.05 ＜0.01 |
As shown in table 8, treat nasal obstruction after 5 days, watery nasal discharge, hyposmia, xerostomia, nasal mucosa hyperemia, prepare for war the integrated value of cardinal symptoms such as mucosa swelling, nasal secretion and sign, the treatment group is starkly lower than matched group (P＜0.05 or 0.01), illustrate 5 days after the treatment group obvious to the improvement of these symptoms and sign than matched group.
(2) chronic rhinitis
1, two groups of recent total effectses relatively
Two groups of total effectses of table 9 chronic rhinitis are [example (%)] relatively
| Group | The example number | Produce effects | Effectively | Invalid | Total effective rate |
| Treatment group matched group | 94 66 | 54(57.45) 40(60.61) | 38(40.43) 21(31.82) | 2(2.12) 5(7.58) | 92(97.88) 61(92.42) |
x
2＝3.48，P＞0.05
As shown in table 9, treatment group obvious effective rate 57.45%, total effective rate 97.88%; Matched group obvious effective rate 60.61%, total effective rate 92.42%.Two groups relatively, and there was no significant difference (P＞0.05) points out the total curative effect of treatment group similar to matched group.
2, cardinal symptom and sign improvement situation are relatively
Integration difference with cardinal symptom before and after taking medicine or sign is an index, the improvement situation that compares two groups of cardinal symptoms and sign, find the treatment group to the improvement of nasal obstruction than obvious (P＜0.05 of matched group, two groups of there was no significant differences of the improvement situation of all the other Sxs (P＞0.05) the results are shown in Table 10.
The improvement situation comparison of two groups of cardinal symptoms of table 10 chronic rhinitis and sign (x ± s)
| Sx | The treatment group | Matched group | The t value | The P value |
| The difference of integration before and after taking medicine | The difference of integration before and after taking medicine | |||
| The congested schneiderian membrane swelling of nasal obstruction runny nose hyposphresia headache dry cough pharyngalgia schneiderian membrane nasal secretion | 1.40±0.55 1.27±0.70 1.00±0.60 0.56±0.71 0.76±0.54 0.27±0.51 0.21±0.46 1.21±0.67 1.29±0.67 1.09±0.71 | 1.170.60 1.12±0.64 0.800.75 0.35±0.57 0.77±0.63 0.32±0.47 0.27±0.45 1.03±0.68 1.20±0.73 1.120.71 | 2.51 1.38 1.87 1.99 0.11 0.63 0.82 1.66 0.81 0.26 | ＜0.05 ＞0.05 ＞0.05 ＜0.05 ＞0.05 ＞0.05 ＞0.05 ＞0.05 ＞0.05 ＞0.05 |
(3) allergic rhinitis
1, total effects compares in the recent period
Treatment group obvious effective rate 33.33%, total effective rate 84.85%; Matched group obvious effective rate 30%, total effective rate 73.33%.Learn by statistics and handle two groups of there was no significant differences (P＞0.05, table 11).
Two groups of total effectses of table 11 allergic rhinitis are [example (%)] relatively
*
| Group | The example number | Produce effects | Effectively | Invalid | Total effective rate (%) |
| Treatment group matched group | 99 60 | 33(33.33) 18(30.00) | 51(51.52) 26(43.33) | 15(15.15) 16(26.67) | 84(84.85) 44(73.33) |
x
2＝3.19，P＞0.05
2, cardinal symptom improvement situation relatively
Integration differential with four cardinal symptom sneeze of allergic rhinitis before and after taking medicine, watery nasal discharge, nasal obstruction, rhinocnesmus is an index, adds up two groups of improvement degree to cardinal symptom respectively, found that two groups there are no significant difference (P＞0.05, table 21～24).
Sneeze integrated value comparison before and after table 12 allergic rhinitis are taken medicine (x ± s)
| Group | The example number | Before taking medicine | After taking medicine | Front and back are poor |
| Treatment group matched group | 99 60 | 1.62±0.74 1.57±0.62 | 0.95±0.54 0.92±0.56 | 0.67±0.80 0.65±0.78 |
t＝0.15，P＞0.05
Watery nasal discharge integrated value comparison before and after table 13 allergic rhinitis are taken medicine (x ± s)
| Group | The example number | Before taking medicine | After taking medicine | Front and back are poor |
| Treatment group matched group | 99 60 | 2.11±0.70 2.18±0.65 | 1.03±0.74 1.05±0.70 | 1.08±0.99 1.13±0.79 |
t＝0.33，P＞0.05
Nasal obstruction integrated value comparison before and after table 14 allergic rhinitis are taken medicine (x ± s)
| Group | The example number | Before taking medicine | After taking medicine | Front and back are poor * |
| Treatment group matched group | 99 60 | 1.72±0.69 1.71±0.69 | 0.94±0.64 1.13±0.75 | 0.78±0.82 0.58±0.65 |
t＝1.61，P＞0.05
Rhinocnesmus integrated value comparison before and after table 15 allergic rhinitis are taken medicine (x ± s)
| Group | The example number | Before taking medicine | After taking medicine | Front and back are poor * |
| Treatment group matched group | 99 60 | 2.04±0.83 2.12±0.69 | 0.94±0.65 1.03±0.61 | 1.10±0.93 1.08±0.77 |
t＝0.14，P＞0.05
3, sign improvement situation relatively
The integration differential of checking sign with nasal cavity before and after taking medicine is an index, adds up two groups improvement degree respectively, found that significant difference (P＜0.05, table 16), illustrates that the treatment group is obvious than matched group to the improvement of nasal cavity sign.
Nasal cavity sign integrated value comparison before and after table 16 allergic rhinitis are taken medicine (x ± s)
| Group | The example number | Before taking medicine | After taking medicine | Front and back are poor |
| Treatment group matched group | 99 60 | 1.66±0.59 1.58±0.65 | 0.95±0.54 1.13±0.54 | 0.71±0.61 0.45±0.65 |
t＝2.54，P＜0.05
Four, untoward reaction
Treatment is organized in the 300 example observation processes, malaise symptoms person 30 examples in various degree occur, and incidence rate is 10%, and wherein drowsiness, sleepy 22 examples disappear after the drug withdrawal, need not do special handling; Dizzy 3 examples, 2 examples of feeling sick, degree is all lighter, does not need drug withdrawal; 3 examples of having a stomachache; Disappear after the drug withdrawal, need not do special handling.In the matched group 179 routine observation processes, malaise symptoms person 7 examples in various degree occur, incidence rate is 3.91%, wherein drowsiness 5 examples, and dizzy 1 example, dry mouth 1 example, degree is all lighter, need not drug withdrawal and processing.Learn by statistics and handle, two groups of adverse reaction rates have significant difference (x
2=5.83, P＜0.05).
The treatment group take medicine have in 193 examples that reached for 4 weeks 57 examples (accounting for 29.5%) row take medicine before and after routine blood test chemical examination (WBC, RBC, Hb) and GPT, BUN, Electrocardioscopy contrast, every index does not all have obvious change, illustrates that this medicine took for 4 weeks continuously hemopoietic system and the heart, liver, renal function are not had obvious damage.
Matched group take medicine have in 126 examples that reached for 4 weeks 39 examples (accounting for 30.9%) row take medicine before and after routine blood test chemical examination (WBC, RBC, Hb) and GPT, BUN, Electrocardioscopy contrast, every index does not all have obvious change.
The result
General curative effect statistical result shows that medication therapy groups of the present invention is 42.999% to wind and heat in the lung meridian type acute rhinitis obvious effective rate, and total effective rate is 92.52%, and obvious effective rate and total effective rate all are higher than QIANBAI BIYAN PIAN matched group (P＜0.01); To lung meridian intrinsic heat, the evil nose key type chronic rhinitis obvious effective rate that stagnates is 57.45%, and total effective rate is 97.88%, compares with the QIANBAI BIYAN PIAN matched group, and curative effect there was no significant difference (P＞0.05) points out two groups of general curative effects similar substantially; To lung meridian intrinsic heat type allergic rhinitis obvious effective rate is 33.33%, and total effective rate is 84.85%, compares with the hismanal matched group, and curative effect there was no significant difference (P＞0.05) points out two groups of general curative effects similar substantially.
The improvement situation of cardinal symptom and sign relatively, to acute rhinitis, medication therapy groups of the present invention all is better than QIANBAI BIYAN PIAN matched group (P＜0.05 or 0.01) aspect the improving of cardinal symptoms such as nasal obstruction, watery nasal discharge, hyposmia, xerostomia, nasal mucosa hyperemia, nasal mucosa swelling, nasal secretion increase and sign; To chronic rhinitis, medicine composite for curing group of the present invention is better than QIANBAI BIYAN PIAN matched group (P＜0.05) to the aspect of improving of nasal obstruction; To allergic rhinitis, medicine composite for curing group of the present invention is better than hismanal matched group (P＜0.05) to the improvement of nasal cavity sign (nasal mucosa swelling).
Untoward reaction is observed and to be shown, have in medication therapy groups 300 examples of the present invention 10% patient occur in various degree drowsiness, asthenia, dizziness, feel sick, reaction such as stomachache, general degree is all lighter, need not special handling and dies away; There is 3.91% patient untoward reaction such as drowsiness, dizzy, dry mouth to occur in QIANBAI BIYAN PIAN and hismanal matched group 179 examples, two groups of adverse reaction rates have significant difference (P＜0.05), point out this untoward reaction may be for due to the medicine itself, but degree is lighter, in all symptoms of untoward reaction, with drowsiness shared proportion higher relatively (accounting for 73.3%), this may with medicine in to contain the composition of chlorphenamine maleate relevant, Given this, unsuitable steering vehicle, handle machine and work high above the ground etc. to avoid danger during medication.Reach the capable front and back routine blood test (WBC, RBC, Hb) of taking medicine of part patient's (29.5%), liver function (GPT), renal function (BUN), the Electrocardioscopy contrast in 4 weeks at random to taking medicine, each index is not all found obviously to change, 4 weeks of taking medicine continuously are described, can not cause the functional lesion of important organs such as the blood system and the heart, liver, kidney, thereby be safe.
Model case
Tall and erect XX, woman, 31 years old.: the first visit time: on August 11st, 1999.
Medical history: nasal obstruction, watery nasal discharge 3 days appear in the back of suffering from cold, and nasal obstruction is serious during with regard to opinion, nasal mucus yellow skin, hyposmia, headache, xerostomia, slightly cough, pharyngalgia.Check: nasal mucosa acute congestion, swelling, meatus nasi communis has secretions, red tongue, yellow and thin fur, floating and rapid pulse.
Diagnosis: acute rhinitis.
Differential diagnosis in tcm: wind and heat in the lung meridian type.
The treatment process: it is oral to give medicinal tablet of the present invention, and each 4, every day 3 times.Check after 3 days: nasal obstruction obviously alleviates, and nasal mucus reduces, and all the other symptoms disappear substantially, checks that nasal mucosa hyperemia, swelling alleviate, and nasal cavity is not seen secretions, and body of the tongue is red slightly, yellow and thin fur, floating pulse.Check after 5 days continues to take medicine: all diseases disappear substantially, occasionally along the sense nasal obstruction, check that nasal mucosa is congested slightly, no swelling, and tongue, arteries and veins are as usual.Period in a medicine does not have obvious adverse reaction and occurs.
Efficacy evaluation: produce effects.
Claims (9)
1, a kind of pharmaceutical composition for the treatment of Rhinological disease, each crude drug by following weight portion is made: 103～412 parts of Herba Pogostemonis, 128.5～514 parts of Fructus Xanthii, 128.5～514 parts of Herba Centipedae, 64.5～258 parts in Herba Ephedrae, 64.5～258 parts of Flos Chrysanthemi Indicis, 83～332 parts of Radix Angelicae Sinensis, 54.5～218 parts of Radix Scutellariaes, 6.5～26 parts of Pulvis Fellis Suiss, 0.5～2 part of 0.46～1.84 part of Oleum menthae and chlorphenamine maleate.
2, the pharmaceutical composition of treatment Rhinological disease as claimed in claim 1, it is characterized in that the weight portion of each crude drug is: 206 parts of Herba Pogostemonis, 257 parts of Fructus Xanthii, 257 parts of Herba Centipedae, 129 parts in Herba Ephedrae, 129 parts of Flos Chrysanthemi Indicis, 166 parts of Radix Angelicae Sinensis, 109 parts of Radix Scutellariaes, 13 parts of Pulvis Fellis Suiss, 0.92 part of Oleum menthae, 1 part of chlorphenamine maleate.
As the pharmaceutical composition of each described treatment Rhinological disease of claim 1～2, it is characterized in that 3, this pharmaceutical composition is any acceptable clinically suitable formulations.
4, the pharmaceutical composition of treatment Rhinological disease as claimed in claim 3 is characterized in that, this pharmaceutical composition is oral formulations or external preparation.
5, the pharmaceutical composition of treatment Rhinological disease as claimed in claim 4 is characterized in that, described oral formulations is tablet, capsule, granule, powder, pill, oral liquid, syrup or drop pill.
6, the pharmaceutical composition of treatment Rhinological disease as claimed in claim 4 is characterized in that, described external preparation is emplastrum, nasal drop or spray.
7, a kind of method for preparing the arbitrary described pharmaceutical composition of claim 1～2, this method may further comprise the steps:
(1) takes by weighing each raw material by described weight proportion;
(2) respectively Herba Pogostemonis, Fructus Xanthii, Herba Centipedae, Herba Ephedrae, the Flos Chrysanthemi Indici of described weight decocted with water extraction, filter, filtrate is dried to dried cream powder or thick paste after concentrating, and is standby; The Radix Angelicae Sinensis of described weight is added the ethanol of 50%～90% concentration, and reflux, extract, filters, filtrate recycling ethanol and concentrate after, be dried to dried cream powder or thick paste, standby; The Radix Scutellariae of described weight is decocted with water extraction, filter, filtrate merging is dried to dried cream powder or thick paste after concentrating, and is standby; Get above-mentioned gained dried cream powder or thick paste, add Pulvis Fellis Suis and the Oleum menthae and the chlorphenamine maleate of described weight, mixing is made the preparation intermediate, makes preparation through preparations shaping technology again, promptly.
8, as each the application of pharmaceutical composition in preparation treatment Rhinological disease medicine of claim 1～2.
9, application as claimed in claim 8 is characterized in that, described Rhinological disease is acute and chronic rhinitis or allergic rhinitis.
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| CN1368343A (en) * | 2001-02-05 | 2002-09-11 | 杨孟君 | Nano medicine 'Kanglebiyan' and its preparing process |
| CN1515278A (en) * | 2003-01-09 | 2004-07-28 | 临沂新时代药业有限公司 | Chinese medicine composition for curing acute and chronic rhinorrhea with turbid discharge and its preparation method |
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| CN1515278A (en) * | 2003-01-09 | 2004-07-28 | 临沂新时代药业有限公司 | Chinese medicine composition for curing acute and chronic rhinorrhea with turbid discharge and its preparation method |
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| Title |
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| 中医药治疗鼻窦炎近况 王任霞，张夕华.《山东中医杂志》，第23卷第2期 2004 * |
| 安宁牌鼻炎康片显效迅速标本兼治 《实用医学杂志》，第4卷第4期 1988 * |
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