CN100337655C

CN100337655C - Medicine preparation for preventing and treating allergic rhinitis and compliance rhinitis

Info

Publication number: CN100337655C
Application number: CNB2005101054512A
Authority: CN
Inventors: 骆斌; 骆庆峰
Original assignee: Individual
Current assignee: Individual
Priority date: 2005-09-28
Filing date: 2005-09-28
Publication date: 2007-09-19
Anticipated expiration: 2025-09-28
Also published as: CN1742825A

Abstract

The present invention relates to a composition for preventing and/or treating allergic rhinitis and periodic rhinitis, particularly to a medicinal preparation for treating periodic rhinitis and allergic rhinitis caused by deficiency of lung qi, deficiency of defensive qi, and invasion of pathogenic wind; especially, the present invention relates to a capsule for treating the periodic rhinitis and the allergic rhinitis caused by deficiency of lung qi, deficiency of defensive qi, and invasion of pathogenic wind. The present invention is composed of effective components which are prepared by raw materials of traditional Chinese medicines, and acceptable carriers in the pharmacy; the composition of the present invention approximately comprises the following raw materials of the traditional Chinese medicines with the parts by weight: 7 to 9 parts of astragalus roots, 2 to 4 parts of rhizoma atractylodis alba, 2 to 4 parts of radices sileris, 2 to 4 parts of dahurian angelica, 4-6 parts of Chinese ephedra, 2 to 4 parts of magnolia, and 3 to 5 parts of tree peony bark.

Description

A kind of pharmaceutical preparation that prevents and/or treats allergic rhinitis, allergic rhinitis

Technical field

The present invention relates generally to a kind of compositions that prevents and/or treats allergic rhinitis, allergic rhinitis.Especially, the present invention relates to treat the pharmaceutical preparation of allergic rhinitis due to lung deficiency of defensive qi, the ailment said due to cold or exposure invasion and attack, allergic rhinitis.Especially, the present invention relates to treat the capsule of allergic rhinitis due to lung deficiency of defensive qi, the ailment said due to cold or exposure invasion and attack, allergic rhinitis, its commodity are called screen nose relieving capsule.

Background technology

Allergic rhinitis (Allergic rhinetis, AR) also claim allergic rhinitis, it is a kind of nasal mucosa allergic disease that causes by susceptible individual contact allergen, it also is the common disease of population of China, be cardinal symptom with sneeze, snivel, nasal obstruction and rhinocnesmus clinically, and can increase the morbidity chance of sinusitis, otitis media, nasal polyp and bronchial asthma indirectly.Over nearly 20 years along with the rapid variation of industrialized progress, life style and environment for human survival, the allergic rhinitis sickness rate has global ascendant trend, its sickness rate accounts for 10%～20% of world's total population, some countries and regions even higher, and China has 2,000 ten thousand people to suffer from this disease every year approximately.Treat based on Western medicine clinically at present, but radical cure difficulty, side effect is bigger, and therefore the relapse rate height is sought and exploitation has antiallergic, the Chinese medicine that improves the allergic constitution effect is subjected to the insider common concern.

CN1671404A relates to Semen Cucurbitae and 2 kinds of crude drugs of Flos Carthami and is selected from Herba Plantaginis, Flos Lonicerae, Radix Glycyrrhizae, Semen Coicis, Rhizoma Zingiberis, Rhizoma Curcumae Longae, Rhizoma Curcumae, the Radix Artemisia ordosicae at least a crude drug as prevention and treatment pollinosis, allergic rhinitis, atopic dermatitis, asthma or urticarial compositions, health food or the functional food of effective ingredient.The shortcoming of this invention is the guidance that lacks theory of Chinese medical science, is absorbed in and takes stopgap measures, and the effect that reach radical cure is relatively more difficult.CN1650977A relates to a kind of Chinese medicine for the treatment of rhinitis, be by Radix Saposhnikoviae, Fructus Xanthii, the Radix Angelicae Dahuricae, Herba Schizonepetae, Herba Ephedrae, wild mountain fructus by certain weight proportion, purify, processing, purifying forms.Though expelling wind and cold medicines such as Radix Saposhnikoviae, Fructus Xanthii, the Radix Angelicae Dahuricae, Herba Ephedrae have been used in this invention, also are absorbed in the mistaken ideas of taking stopgap measures, the compatibility between all medicines is unreasonable, though can help to improve symptom, causes the etiology and pathogenesis of disease to be difficult to remove.CN1368187A discloses a kind of nano medicine ' Tongqiaobiyan ', with Fructus Xanthii, Radix Saposhnikoviae, the Radix Astragali, the Radix Angelicae Dahuricae, Flos Magnoliae, the Rhizoma Atractylodis Macrocephalae, Herba Menthae through concocting, microwave water or alcohol extraction, concentrating under reduced pressure, getting concentrated solution and the Chinese medicine volatile material merges, supersonic jet spray drying, get the nanometer prepared slices of Chinese crude drugs, mixing is made dosage forms such as the sensible rhinitis pill of nanometer, powder, tablet, suppository, granule, membrane, capsule, microcapsule, drop pill, aerosol, injection, unguentum, medicated wine, syrup, oral liquid.The present invention deducts Fructus Xanthii, Herba Menthae by comparison, has increased Herba Ephedrae, Cortex Moutan, and optimizes each medicine proportioning, has increased expelling wind and cold, the sharp key of lung qi dispersing, and the detumescence dissipating blood stasis, through comparative experiments, curative effect more is better than this invention.Loyal compound recipe YUPINGFENG SAN electuary (component: Radix Astragali 1000g, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Paeoniae Alba, Rhizoma Zingiberis Recens, Fructus Jujubae, Radix Glycyrrhizae, each 250g of Radix Scutellariae, the Herba Centipedae 500g) treatment of allergic rhinitis that adopts of " Chinese crude drug " 19 (8) report Liu Mei.Although it all has three herbal medicines identical (Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae) with the present invention, other medicines and proportioning differ greatly, and can find out that just the merit of its a surname's clearing the nasal passage is relatively poor from the prescription design, and through experiment relatively, curative effect also is inferior to the present invention.

Summary of the invention

The present invention on the one hand, provides the pharmaceutical preparation that prevents and/or treats allergic rhinitis, allergic rhinitis.On the other hand, the present invention also provides preparation to prevent and/or treat the method for the pharmaceutical preparation of allergic rhinitis, allergic rhinitis.Compatibility of drugs characteristics of the present invention are based on theory of Chinese medical science, control with treatment based on differentiation of disease, distinguish on the body opinion basis of controlling in comprehensive dialectical opinion, by characteristics of incidence: the taking all factors into consideration of constitutive character, environmental quality to present allergic rhinitis, under the guidance of traditional Chinese medical science monarch combination principle, be based on the principle of effecting a permanent cure for the treatment of both the principal and the secondary aspects of a disease at the same time.The invention has the advantages that: in effective controlling symptoms, can also improve the immunity of function, improve allergic constitution, reach anxious and can take stopgap measures the slow effect that can effect a permanent cure; Improved clinical efficacy greatly, and to the outbreak of prevention of allergic rhinitis, increase the weight of that important effect is arranged; Owing to can effectively improve allergic constitution, raise immunity.So can fundamentally treat allergic rhinitis, this be general symptomatic treatment allergic rhinitis when can not possess this medicine can also block allergic rhinitis and develop to allergic asthma.Clinical drug of the present invention is evident in efficacy, for improving curative effect, organizes the related process expert that this medicine is carried out technologic design again.Through accurate Calculation and design, determined production technology and clinical treatment amount, guaranteed the advanced person of production technology, this medicine can be brought into play effective ingredient and scientific and reasonable therapeutic dose every day to greatest extent.

Preparation of the present invention is the feedstock production effective ingredient with the botanical herbs, adds that pharmaceutically acceptable preparing carriers forms, and material medicine comprises the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae and Cortex Moutan.Further, preparation of the present invention can also contain Herba Houttuyniae, Fructus Mume.Further, preparation of the present invention can also contain Radix Glycyrrhizae.Medicament benefiting QI for strengthening the superficies of the present invention, a surname's clearing the nasal passage.Be used for the lung deficiency of defensive qi, allergic rhinitis due to ailment said due to cold or exposure is attacked, disease is seen rhinocnesmus, sneeze, nasal obstruction, snivel, anemophobia spontaneous perspiration; Allergic rhinitis is seen above-mentioned card marquis person.

" allergic rhinitis " claims " having a stuffy nose ", " sneezing ", " allergic rhinitis with sneezing " again, all be to name with its symptom, " allergic rhinitis " head sees " element ask arteries and veins separate a piece of writing ", it is said: " so-called objective grandson's arteries and veins; the swollen person of then headache, allergic rhinitis, abdomen; Yang Ming and in last, its grandson's network of last person is also lunar, so headache, allergic rhinitis, abdomen are swollen also ".Theory of Chinese medical science thinks that the primary disease cause of disease is to disturb key clearly on the ailment said due to cold or exposure, sees rhinocnesmus, and sneeze is frequent, thin nasal discharge such as water, symptoms such as nasal obstruction.Sick position is at nose, and nose is a key outside the lung.Ailment said due to cold or exposure invasion, Lung Qi obstraction and stuffy nose; Obstinate disease is insufficiency of lung-QI then, failure of defensive QI to protect the body against pathogen and easy catching a cold.The lung belonging to metal, spleen pertaining to the earth, spleen soil is the mother of lung gold, prolonged illness and insufficiency of lung-QI, child-organ disease involving its motherorgan, deficiency of spleen-QI, lifting mistake department, fortuneization can not, easier lung spleen two dirty tool void, the insufficient situation of the four stages in the course of an epidemic febrile disease of causing, thereby cause the pathogenic factor repetition offence, deficiency in origin and excess in superficiality, evil victory is weakened body resistance, and real is the primary disease pathogenesis.

The present invention adopts prescription for the lung deficiency of defensive qi, the disease of allergic rhinitis due to the ailment said due to cold or exposure invasion and attack and establishing.The sweet tepor of the Radix Astragali in the side main is gone into the spleen lung meridian, sweet can complementary energy and, essentials of Matea Medica carries to be said: " process and use invigorating middle warmer; beneficial vigour, strong taste, warm three warmers ", " Yaoxing Fu " also sayed: " beneficial vigour and mend three warmers; ... the night sweat of outer consolidating superficial resistance void ", Miraculous Pivot cloud " Radix Astragali had both been mended three warmers, the real gas of defending " is so the Radix Astragali is a replenishing and restoring lung-QI, consolidating superficial resistance is real defends the key medicine of strengthening vital QI to eliminate pathogenic factors.This medicine is at the lung deficiency of defensive qi, and that the ailment said due to cold or exposure invasion and attack cause the main pathogenesis of allergic rhinitis is set, is the monarch drug in just admittedly.

The Rhizoma Atractylodis Macrocephalae is bitter sweet warm in nature, the main taste warp of returning, " explaining abstruseness of the canon of materia medica " meaning " Rhizoma Atractylodis Macrocephalae; the medicine of tonifying the spleen and stomach ", " Records of Tradition Chinese and Western Medicine in Combination " speech " be that its tool soil moral is complete, is the key medicine of back natural gift life, so can be in gold, wood, water, fiery four dirty; all can be also of some help ", " Amplification on Materia Medica addendum " be cloud also: " have antiperspirant then to end again, losslessly then send out, with the same merit of the Radix Astragali ", so the Rhizoma Atractylodis Macrocephalae is invigorating the spleen and benefiting QI, the panacea of strengthening superficial resistance to stop perspiration.The Rhizoma Atractylodis Macrocephalae is intended to building up the spleen to supplement the lung in the side, helps the Radix Astragali to strengthen benefiting QI for strengthening the superficies, and the power of strengthening vital QI to eliminate pathogenic factors makes the prosperous table of gas real, invades in then exopathogen is difficult to, and is ministerial drug; Radix Saposhnikoviae is hot sweet warm in nature, mainly returns bladder, liver, spleen channel, and " herbal classic " calls it: " main air heresy ", " medicine origin " record " it is general to treat wind, and the elixir that removes part of the body cavity above the diaphragm housing the heart and lungs ailment said due to cold or exposure is also ", so Radix Saposhnikoviae be the dispelling wind that induces sweat, the victory eliminating evil elixir that wets.Radix Saposhnikoviae walks table and the wind that looses is driven evilly in the side, and Radix Saposhnikoviae gets the stilbene art, then dispels the wind and does not just hinder; The stilbene art gets Radix Saposhnikoviae, tonify without causing stagnation then, and fluent battalion defends.The Radix Saposhnikoviae and the Rhizoma Atractylodis Macrocephalae are held concurrently and assist energy of monarch drug, be ministerial drug altogether, the monarch and his subjects match invigorating middle warmer have thin, the diffusing middle benefit of residing.

The hot little bitter temperature of Herba Ephedrae, the master goes into lung, urinary bladder channel, " medicine justice " calls it " Herba Ephedrae, for the medicine of delivering the heresy of loosing also ", and " the southern regions of the Yunnan Province book on Chinese herbal medicine " also says " control stuffy nose is obstructed, good and foul smells not to be heard ", " solar corona " calls it " logical nine orifices ", so Herba Ephedrae is expelling wind and cold, the principal agent of the sharp key of lung qi dispersing, Herba Ephedrae can be improved nasal obstruction by principal drug assistance, the symptom of watery nasal discharge, the energy that has assistant to help; Radix Angelicae Dahuricae acrid in the mouth is warm in nature, and the master goes into lung stomach warp, and " property of medicine opinion " carried and said: " exorcising ", and " Mingyi Bielu " be cloud also: " curing mainly ailment said due to cold or exposure ", " solar corona " speech: " its gas fragrance is controlled cacorhinia, expelling the toxic substance from the body with tonic ", so the Radix Angelicae Dahuricae has dispersing wind and cold, sending up the lucid YANG, the function of clearing the nasal passage, the power that has assistant to help; The Flos Magnoliae acrid in the mouth is warm in nature, returns lung stomach warp, " not Lu " language: " warming middle-JIAO expelling pathogenic factors from muscles, sharp nine orifices, stuffy nose relieving plug ", " the medical center bun medicine property of medicine " " the eliminating the pathogens from the lung heresy, consciousness restoring reduces phlegm and internal heat and dispels the wind meaning." so Flos Magnoliae is a dispersing wind and cold, the special-purpose medicine of the treatment allergic rhinitis of clearing the nasal passage, the energy that has assistant to help; The Herba Houttuyniae acrid in the mouth, cold nature, return lung, bladder, large intestine channel, Shi Zhenyun: " malicious carbuncle dispels the heat ", " herbal lease making " carries language " detoxifcation of purging heat ", so but Herba Houttuyniae lung heat clearing pathogenic fire purging, removing toxic substances and promoting subsidence of swelling is to remove the fraud of the strongly fragrant heat-transformation of a specified duration of wind and cold, the usefulness that has assistant to help; The Fructus Mume sour in the mouth is flat, returns liver, spleen, lung, large intestine channel, and " medication heart method " cloud: " receipts lung qi ", " detailed outline " also calls " astringing the lung ", so Fructus Mume has the function of astringing the lung, can restrict too the property of dispersing of Radix Saposhnikoviae, Herba Ephedrae, the Radix Angelicae Dahuricae, Flos Magnoliae, is the merit of helping system; The Cortex Moutan toil is slightly cold, GUIXIN, liver, kidney channel, and " Japan hanako materia medica " meaning: " disappear to pounce on and decrease blood stasis ", Jing-Yue Complete Works is said: " treat carbuncle and live pain ", so Cortex Moutan is the product of detumescence dissipating blood stasis, the energy that has assistant to help.Above-mentioned all medicines share both can help principal drug assistance dispelling wind heresy, sending up the lucid YANG, and clearing the nasal passage can be helped all diaphoretic medicines of system again, in case table looses too, is adjuvant drug altogether.

The Radix Glycyrrhizae sweet in the mouth is flat, GUIXIN, lung, spleen, the stomach warp, " property of medicine opinion " speech " mediation makes all medicines meritorious; ... tonification five Tibetan, make all poison of drug ", " medication heart method " puts down in writing " slow its heat that the medicine of a warm nature is used; cold medicinal slow its trembled with fear ", so Radix Glycyrrhizae is used strengthening the body resistance, and the power of the mediation property of medicine, both can help the energy of principal drug assistance enhancing strengthening the body resistance, can be in harmonious proportion the property of medicine again, make and mend the appropriateness of loosing, holding concurrently is adjuvant.

All medicine compatibilities are played benefiting QI for strengthening the superficies altogether, the effect of a surname's clearing the nasal passage, thus the lung deficiency of defensive qi, allergic rhinitis due to ailment said due to cold or exposure is attacked, disease sees that rhinocnesmus, sneeze, nasal obstruction, snivel, anemophobia spontaneous perspiration use it, then all disease knowing are separated.

In preferred embodiments, in weight portion, this preparation comprises that approximately the plant material of following weight portion is as follows: Radix Astragali 7-9, Rhizoma Atractylodis Macrocephalae 2-4, Radix Saposhnikoviae 2-4, Radix Angelicae Dahuricae 2-4, Herba Ephedrae 4-6, Flos Magnoliae 2-4, Cortex Moutan 3-5, perhaps these equivalent fresh plant raw materials of plant separately under ratio instruction.Preferably, the Radix Astragali is a processed with honey.Further, preparation of the present invention can also approximately contain Herba Houttuyniae 2-4, Fructus Mume 2-4.Further, preparation of the present invention can also approximately contain the Radix Glycyrrhizae of 2-4.

On the other hand, the present invention's instruction reduces the size of botanical drug substance, mixes the method that is suitable for the mixture of doing pharmaceutical preparation to form, and perhaps extracts with appropriate solvent, then concentrates the method that is suitable for the effective ingredient of doing pharmaceutical preparation to form.

In the present invention's first embodiment preferred in this respect, reduce step and preferably finish by pulverizing Chinese medicine, then mix to form being suitable for the mixture of doing pharmaceutical preparation.

In the present invention's second embodiment preferred in this respect, reducing step preferably finishes by pulverizing Chinese medicine, extraction step comprises with water, methanol, ethanol, normal hexane, supercritical carbon dioxide backflow feedstock production extract, then concentrates to form and is suitable for the mixture of doing pharmaceutical preparation.In instruction of the present invention, any of these extracting method can obtain purified extract succeeded by purifying process.

In the present invention's the 3rd embodiment preferred in this respect, reducing step preferably finishes by pulverizing Chinese medicine, extraction step comprises: with the water extraction Radix Astragali, Herba Ephedrae, if contain in Fructus Mume, Radix Glycyrrhizae, the Herba Houttuyniae any, two or three, also extract preparation extract 1 together with the Radix Astragali, Herba Ephedrae; Prepare extract 2 with the alcohol reflux Radix Angelicae Dahuricae; Steam distillation Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae, Flos Magnoliae, Cortex Moutan must contain the fraction 3 and the medicinal residues 4 of volatile oil; Get extract 5 with water extraction medicinal residues 4; United extraction thing 1,2,3 and 5 is suitable for the mixture of doing pharmaceutical preparation to form.

Most preferably, reduce step and preferably finish by pulverizing Chinese medicine, extraction step comprises: with the water extraction Radix Astragali, Herba Ephedrae, if contain in Fructus Mume, Radix Glycyrrhizae, the Herba Houttuyniae any, two or three, also extract together with the Radix Astragali, Herba Ephedrae, filter, concentrate, prepare dried cream A; With the alcohol reflux Radix Angelicae Dahuricae, concentrate drying prepares dried cream B; Steam distillation Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae, Flos Magnoliae, volatile oil C, filter medicinal residues C1, water extract C2; The steam distillation Cortex Moutan, extract Aromatic water place paeonol crystallization D, filter water extraction medicinal residues D1, water extract D2; Water extraction D1 and C1 get water extract E; C2, D2 and E merge, and concentrate, and precipitate with ethanol filters, and concentrate drying prepares dried cream F; A, B, C, D and F mix, and are suitable for the mixture of doing pharmaceutical preparation to form.

Dosage form of the present invention can be the dosage form on any pharmaceutics.Except capsule, effective ingredient of the present invention can be supplied with and be tablet, pill, water or oil suspension, powder or granule, Emulsion, hard or soft capsule, syrup, elixir, microcapsule, spray, or oral liquid.The preparation that plan orally uses can prepare according to the known method that this area pharmaceutically acceptable preparation of any preparation is used, and such preparation comprises one or more of following reagent: sweetener, flavoring agent, coloring agent and antiseptic.Sweetener and flavoring agent can increase the palatability of preparation.The tablet of extract that contains and be suitable for the nontoxic pharmaceutically acceptable mixed with excipients of preparation tablets is acceptable.Pharmaceutically acceptable mean with the meaning of other component compatibility of preparation on, this reagent should be acceptable (and be harmless to patient).Such excipient comprises inert diluent for example calcium carbonate, sodium carbonate, lactose, calcium phosphate or sodium phosphate; Granulating and distintegrant, for example corn starch or alginic acid; Binding agent is starch, gelatin or arabic gum for example; With lubricant for example magnesium stearate, stearic acid or Talcum.Tablet can be a coating not, perhaps by the known technology coating delaying in gastrointestinal disintegrate and absorption, thereby continuous action was provided in the long term.For example, adopt time-delay material such as glyceryl monostearate or distearin together separately or with wax.

Orally using preparation can also be hard-gelatin capsules, wherein active component is mixed with inert solid diluent, for example calcium carbonate, calcium phosphate or Kaolin, or soft capsule capsule, wherein active component is mixed with water or oily medium, for example Oleum Arachidis hypogaeae semen, liquid paraffin or olive oil.In some embodiment, water slurry can comprise and be suitable for the extract of the present invention of the mixed with excipients of water slurry preparation.Such excipient comprises suspending agent, dispersion or wetting agent, one or more antiseptic, one or more coloring agent, one or more flavoring agents and one or more sweeting agents, for example sucrose or glucide.Oil suspension can be by in for example Oleum Arachidis hypogaeae semen, olive oil, Oleum sesami or Oleum Cocois vegetable oil, and perhaps in the mineral oil as liquid paraffin, the suspension active component is prepared.Oil suspension comprises thickening agent, for example Cera Flava, hard paraffin or spermol.Can add sweeting agent, those of illustrating more than for example, and flavoring agent are to provide good to eat oral formulations.These preparations can be by adding for example ascorbic acid preservation of antioxidant.Be suitable for that entry prepares the dispersibility powder of the present invention of water slurry or granule provides and dispersion or blended one or more extracts of wetting agent, suspending agent and one or more antiseptic by adding.Also can there be extra excipient, for example sweet taste, strong smelly and coloring agent.

Oral liquid, syrup and elixir can sweeting agent preparation, for example glycerol, stevioside, sorbitan or sucrose.Such preparation also comprises demulcent, antiseptic, flavoring or coloring agent.

Parenterai administration can be aseptic injectable formulation with extracting preparation, for example the water of sterile injectable, oil suspension or liposome.This suspension can adopt suitable dispersion or wetting agent and suspending agent preparation according to method well known in the art.This aseptic injection preparation can also be nontoxic non-intestinal acceptable diluent or the solution or the suspension of solvent, for example the 1,3 butylene glycol solution of sterile injectable.The suitable dilution agent comprises, for example, water, Ringer's mixture and etc. open sodium chloride solution.In addition, adopt aseptic fixed oil as solvent or suspension media by convention.For this purpose, can adopt the fixed oil of any gentleness, comprise synthetic list or diglyceride.In addition, for example oleic fatty acid equally also is used for the preparation of this ejection preparation.

Pharmaceutical preparation can also be oil in water emulsion.Oil phase can be a vegetable oil, for example olive oil or Oleum Arachidis hypogaeae semen, for example mineral oil of liquid paraffin, perhaps their mixture.The natural gum that suitable emulsifying agent comprises natural formation is arabic gum and tragakanta for example, the phospholipid of natural formation, soybean lecithin for example, be derived from the esters or the partial ester class of fatty acid and hexitol anhydride, sorbitan monooleate for example, with the condensed products of these partial esters and oxirane, for example Tween-81.Emulsion also can contain sweeting agent and flavoring agent.

The quantity that can mix with carrier mass with the extract that produces single dosage form will depend on that the host of treatment and concrete administering mode change.

Though the present invention can be a medicine, it can also be consumed as health product, in other words, and for any specific clinical purpose is designed to nutrition or healthy supplement.Thereby it is suitable for general consumption as nutrition or healthy supplement.

The purposes of the compositions that the present invention provides more than also instructing in being suitable for treating the medicament of mammal allergic rhinitis, allergic rhinitis.

Therefore, the present invention further also relates to medicament or healthy supplement, in the treatment of allergic rhinitis, allergic rhinitis, it can per os or whole body be applied to whole health with its effect of performance in darker tissue.

The present invention also provides the method for controlling product quality of the present invention by chromatography.

The specific embodiment

Employed as this description and claim, term " comprises ", " containing " mean " comprise, but must not be limited to ".For example, a kind of method, device, molecule or other project that comprises A, B and C can be said to comprise A and B exactly.Equally, the method for a kind of " comprising A and B ", device, molecule or other project also can comprise additional step, component, atom or other project etc. of any number.Term " composition basically " means term and " comprises " narrower viewpoint, and wherein additional step, component, atom or other project are subjected to more restrictions, for example, and to more extra such step or projects.Term " composition " means the method, device, molecule or other project that comprise A, B and C and only limits to A, B and C.

Equally, unless otherwise indicated, all technology used herein and scientific terminology have with the present invention under the identical implication of field those of ordinary skill common sense.

1. the material medicine of preparation of the present invention

The present invention relates to a kind of compositions that prevents and/or treats allergic rhinitis, allergic rhinitis, it is to be formed by effective ingredient and pharmaceutically acceptable preparing carriers, and wherein the employed material medicine of effective ingredient comprises the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae and Cortex Moutan.Further, raw material of the present invention also comprises Herba Houttuyniae, Fructus Mume.Further, preparation of the present invention can also comprise Radix Glycyrrhizae.

All Chinese medicines that use in preparation of the present invention and the research are differentiated in strict standard and requirement according to Pharmacopoeia of People's Republic of China (2000 editions, I portion).Carry out morphology and microscopy, and chemical analysis, wherein monographic data are to acquire.That uses in Chinese medicine name used herein and the Pharmacopoeia of People's Republic of China (2000 editions, I portion) is identical, and should explain according to this publication.

1.1 the proportioning of material medicine

In a practice of the present invention, preparation of the present invention comprises the approximately plant material of following weight portion:

The Radix Astragali 7, the Rhizoma Atractylodis Macrocephalae 2, Radix Saposhnikoviae 2, the Radix Angelicae Dahuricae 2, Herba Ephedrae 4, Flos Magnoliae 2, Cortex Moutan 3.

In another practice, preparation of the present invention comprises the approximately plant material of following weight portion:

The Radix Astragali 9, the Rhizoma Atractylodis Macrocephalae 4, Radix Saposhnikoviae 4, the Radix Angelicae Dahuricae 4, Herba Ephedrae 6, Flos Magnoliae 4, Cortex Moutan 5.

The Radix Astragali 8, the Rhizoma Atractylodis Macrocephalae 3, Radix Saposhnikoviae 3, the Radix Angelicae Dahuricae 3, Herba Ephedrae 5, Flos Magnoliae 3, Cortex Moutan 4.

The Radix Astragali 7, the Rhizoma Atractylodis Macrocephalae 2, Radix Saposhnikoviae 2, the Radix Angelicae Dahuricae 2, Herba Ephedrae 4, Flos Magnoliae 2, Cortex Moutan 3, Herba Houttuyniae 2, Fructus Mume 2.

The Radix Astragali 9, the Rhizoma Atractylodis Macrocephalae 4, Radix Saposhnikoviae 4, the Radix Angelicae Dahuricae 4, Herba Ephedrae 6, Flos Magnoliae 4, Cortex Moutan 5, Herba Houttuyniae 4, Fructus Mume 4.

The Radix Astragali 7.5, the Rhizoma Atractylodis Macrocephalae 2.5, Radix Saposhnikoviae 2.5, Herba Ephedrae 4.5, the Radix Angelicae Dahuricae 2.5, Flos Magnoliae 2.5, Herba Houttuyniae 2.5, Fructus Mume 2.5, Cortex Moutan 3.5.

The Radix Astragali 7, the Rhizoma Atractylodis Macrocephalae 4, Radix Saposhnikoviae 4, Herba Ephedrae 4, the Radix Angelicae Dahuricae 4, Flos Magnoliae 4, Herba Houttuyniae 4, Fructus Mume 4, Cortex Moutan 4.

Most preferably, preparation of the present invention comprises the approximately plant material of following weight portion:

The Radix Astragali (processed with honey) 8, the Rhizoma Atractylodis Macrocephalae 3, Radix Saposhnikoviae 3, Herba Ephedrae 5, the Radix Angelicae Dahuricae 3, Flos Magnoliae 3, Herba Houttuyniae 3, Fructus Mume 3, Cortex Moutan 4, Radix Glycyrrhizae 3.

2. the preparation of effective ingredient

2.1 pulverize

Pulverize the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae and the Cortex Moutan of ormal weight, if contain in Fructus Mume, Radix Glycyrrhizae, the Herba Houttuyniae any, two or three, also pulverize together with the aforementioned base materials medicine, sieve, promptly get effective ingredient VII.

2.2 extract

2.2.1 general extracting method

General extracting method comprises the size of the raw material of Chinese medicine that reduces ormal weight, then with the appropriate solvent reflux, extract.Reducing on the size can reach by pulverizing these raw materials.

Concentrate and or dry extract by rotary evaporation in vacuo then.In order to determine to have the best practice of best expectation pharmacological action, component of the present invention stands the combination of all water, methanol, ethanol, normal hexane and/or supercritical carbon dioxide extraction method.Any point in method, the intermediate product of any step stands to concentrate, clarification or purification step.Be further purified and test some extract so that improve effect thereafter.

2.2.2 concrete extracting method

Method I

Getting the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae and the Cortex Moutan of ormal weight pulverizes, if contain in Fructus Mume, Radix Glycyrrhizae, the Herba Houttuyniae any, two or three, also pulverize together with the aforementioned base materials medicine, decoct with water 2-3 time, collecting decoction, filter, the thick paste that filtrate is concentrated into promptly gets effective ingredient I.

Method II

Getting the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae and the Cortex Moutan of ormal weight pulverizes, if contain in Fructus Mume, Radix Glycyrrhizae, the Herba Houttuyniae any, two or three, also pulverize together with the aforementioned base materials medicine, add alcohol reflux, merge extractive liquid, filters the thick paste that filtrate is concentrated into, reclaim ethanol, promptly get effective ingredient II.

Method III

Getting the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae and the Cortex Moutan of ormal weight pulverizes, if contain in Fructus Mume, Radix Glycyrrhizae, the Herba Houttuyniae any, two or three, also pulverize together with the aforementioned base materials medicine, adding normal hexane refluxes, merge extractive liquid,, filter, reclaim solvent, promptly get effective ingredient III.

Method IV

Getting the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae and the Cortex Moutan of ormal weight pulverizes, if contain in Fructus Mume, Radix Glycyrrhizae, the Herba Houttuyniae any, two or three, also pulverize together with the aforementioned base materials medicine, decoct with water 2-3 time, collecting decoction adds ethanol precipitation, filter, filtrate recycling ethanol, the thick paste that is concentrated into promptly gets effective ingredient IV.

Method V

Get the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae and the Cortex Moutan of ormal weight.Boil the Radix Astragali, Herba Ephedrae 2-3 time with decocting, if contain in Fructus Mume, Radix Glycyrrhizae, the Herba Houttuyniae any, two or three, also decoct together with the Radix Astragali, Herba Ephedrae, collecting decoction filters, is concentrated into thick paste, preparation extract 1; With the alcohol reflux Radix Angelicae Dahuricae, get extracting solution and reclaim ethanol, concentrate, preparation extract 2; Steam distillation Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae, Flos Magnoliae, Cortex Moutan must contain fraction 3 and the medicinal residues 4 and the distilled water solution 5 of volatile oil; With decocting decoct medicinal herbs slag 4 2-3 time, collecting decoction and distilled water solution filter, are concentrated into thick paste, extract 6; Merging 1,2,6 and fraction 3 promptly get effective ingredient V.

Method VI

Get the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae and the Cortex Moutan of ormal weight.Boil the Radix Astragali, Herba Ephedrae 2-3 time with decocting, if contain in Fructus Mume, Radix Glycyrrhizae, the Herba Houttuyniae any, two or three, also decoct together with the Radix Astragali, Herba Ephedrae, collecting decoction filters, is concentrated into thick paste, prepares dried cream A; With the alcohol reflux Radix Angelicae Dahuricae, to get extracting solution and reclaim ethanol, concentrate drying prepares dried cream B; Steam distillation Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae, Flos Magnoliae, volatile oil C, filter medicinal residues C1, water extract C2; The steam distillation Cortex Moutan, extract Aromatic water place paeonol crystallization D, filter water extraction medicinal residues D1, water extract D2; Water extraction D1 and C1 2-3 time get decocting liquid E; C2, D2 and E merge, and concentrate, and precipitate with ethanol filters, and concentrate drying prepares dried cream F; A, B, C, D and F mix, and promptly get effective ingredient VI.

Can be further purified and derive from preparation extract any in the above-mentioned various feasible method.A kind of method that increases the purity of expectation is to make extract stand one or more isolation technics, wherein reduces unwanted component, thereby increases the relative abundance of wanting component in the extract.

3. the embodiment of preparation of pharmaceutical formulations

3.1 powder

The Radix Astragali (processed with honey) 700g, Rhizoma Atractylodis Macrocephalae 200g, Radix Saposhnikoviae 200g, Herba Ephedrae 400g, Radix Angelicae Dahuricae 200g, Flos Magnoliae 200g, Cortex Moutan 300g, an amount of sucrose.

Pulverize the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae, Herba Houttuyniae, Fructus Mume and the Cortex Moutan of ormal weight, cross the 80-100 mesh sieve, add an amount of sucrose, the packing pouch, every bag 6 gram, promptly.Consumption and usage: one day three times, each 1-2 bag, with eliminating cold for resuscitation water with become pasty state to swallow.

3.2 oral liquid

The Radix Astragali (processed with honey) 900g, Rhizoma Atractylodis Macrocephalae 400g, Radix Saposhnikoviae 400g, Herba Ephedrae 600g, Radix Angelicae Dahuricae 400g, Flos Magnoliae 400g, Cortex Moutan 500g.

Getting the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae and the Cortex Moutan of ormal weight pulverizes, decoct with water 2-3 time, each water yield is crude drug 8-12 times, collecting decoction, cold preservation was left standstill 24 hours, filter, mix homogeneously adds an amount of stevioside, antiseptic, adding the injection water again is supplemented to every 10ml oral liquid and contains 6g crude drug amount, divide to be filled to bottle, every bottle of 10ml, promptly.Consumption and usage: one day three times, each 20ml.

3.3 hard capsule

Technology one: Radix Astragali 800g, Rhizoma Atractylodis Macrocephalae 300g, Radix Saposhnikoviae 300g, Radix Angelicae Dahuricae 300g, Herba Ephedrae 500g, Flos Magnoliae 300g, Cortex Moutan 400g.Get an amount of sucrose, Pulvis Talci, magnesium stearate again.Pulverize the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae and the Cortex Moutan of ormal weight, cross the 100-120 mesh sieve, add sucrose, Pulvis Talci, magnesium stearate, uniform mixing, encapsulated, every 2 gram.Consumption and usage: one day 3-4 time, each 2-4 grain.

Technology two: the Radix Astragali (processed with honey) 800g, Rhizoma Atractylodis Macrocephalae 300g, Radix Saposhnikoviae 300g, Herba Ephedrae 500g, Radix Angelicae Dahuricae 300g, Flos Magnoliae 300g, Herba Houttuyniae 300g, Fructus Mume 300g, Cortex Moutan 400g, Radix Glycyrrhizae 300g.

1, the Radix Astragali, Herba Ephedrae, Fructus Mume, Radix Glycyrrhizae, Herba Houttuyniae totally 5 flavors decoct with water 2-3 extraction, at every turn the water yield be crude drug 8-12 times (preferred 2 times, 10 times, the 1st time 2 hours, the 2nd time 1 hour), filter, merging filtrate, concentrated, concentrated solution high speed centrifugation, centrifugal liquid concentrate drying become dried cream A.

2, the Radix Angelicae Dahuricae adds ethanol 70%-80% reflux, extract, simply, the extracting solution concentrate drying, and B gets dry extract.

3, steam distillation Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae, Flos Magnoliae, volatile oil C, filter medicinal residues C1, water extract C2.

4, steam distillation Cortex Moutan, extract Aromatic water place paeonol crystallization D, filter water extraction medicinal residues D1, water extract D2; Water boiling and extraction D1 and C1 2-3 time, each water yield is medicinal residues 8-12 times, gets decocting liquid E;

5, C2, D2 and E merge, and concentrate, and add 95% ethanol and are 60%-80% to containing the alcohol amount, and cold preservation is placed, and filter the supernatant concentration drying F that gets dry extract.

6, A, B, F merging crushing screening get medicated powder, and paeonol D is ground into fine powder, and equivalent incremental method and above-mentioned medicated powder merge mixing, and volatile oil C adds 95% dissolve with ethanol, sprays into above-mentioned medicated powder, mixing.

7, the system soft material is granulated, granulate, and the hard capsule of packing into, the 0.5g/ grain, every is equivalent to contain crude drug 4.2g, and packing promptly gets screen nose relieving capsule.

Consumption and usage: one day three times, each 3, one month is a course of treatment.

3.4 soft capsule

The Radix Astragali (processed with honey) 735g, Rhizoma Atractylodis Macrocephalae 280g, Radix Saposhnikoviae 280g, Radix Angelicae Dahuricae 280g, Herba Ephedrae 455g, Flos Magnoliae 280g, Herba Houttuyniae 280g, Cortex Moutan 350g, Fructus Mume 280g, Radix Glycyrrhizae 280g.

Boil the Radix Astragali, Herba Ephedrae, Fructus Mume, Radix Glycyrrhizae, Herba Houttuyniae 2-3 time with decocting, each water yield be crude drug 8-12 doubly, filter, merging filtrate, concentrate, it is 1.15 clear paste A that concentrated solution high speed centrifugation, centrifugal liquid concentrate drying become relative density; With 70-80% alcohol reflux Radix Angelicae Dahuricae 2-3 time, each 1-2 hour, get extracting solution and filter, merging filtrate, reclaiming ethanol, being concentrated into relative density is 1.15 clear paste B; Steam distillation Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae, Flos Magnoliae, Cortex Moutan obtain the aqueous solution after volatile oil and the distillation, and decoct with 8-12 times of water gaging and heat up in a steamer the back medicinal residues 2-3 time, the aqueous solution after collecting decoction and the distillation, filtration is concentrated into relative density and is 1.15 clear paste C.Merge clear paste A, B and C, be concentrated into the thick paste that relative density is 80 ℃ of following 1.30-1.35, drying under reduced pressure is ground into fine powder, crosses the 100-120 mesh sieve; Other gets edible vegetable oil 340-380 weight portion, and it is an amount of to add Cera Flava etc., and temperature is treated in fusing, adds above-mentioned powder and volatile oil, and is even through the colloid mill mill, is pressed into soft capsule, and every is equivalent to contain crude drug 4-4.5g.Consumption and usage: one day three times, each 3.

3.5 tablet

The Radix Astragali (processed with honey) 700g, Rhizoma Atractylodis Macrocephalae 200g, Radix Saposhnikoviae 200g, Radix Angelicae Dahuricae 200g, Herba Ephedrae 400g, Flos Magnoliae 200g, Herba Houttuyniae 200g, Cortex Moutan 300g, Fructus Mume 200g.

Get the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae, Fructus Mume, Herba Houttuyniae and the Cortex Moutan of ormal weight and pulverize, decoct with water 2-3 time, each water yield is crude drug 8-12 times, filter, collecting decoction adds ethanol and makes and contain the alcohol amount and be 50-70%, stir evenly, supernatant is got in cold preservation 24 hours, filter, filtrate recycling ethanol is concentrated into the thick paste of 1.30-1.35, add an amount of carboxymethyl starch sodium, micropowder silica gel, magnesium stearate, lactose, mix homogeneously is granulated tabletting.Every is equivalent to contain crude drug 3g.Consumption and usage: one day three times, each 3.

3.6 microcapsule

Radix Astragali 700g, Rhizoma Atractylodis Macrocephalae 400g, Radix Saposhnikoviae 400g, Herba Ephedrae 400g, Radix Angelicae Dahuricae 400g, Flos Magnoliae 400g, Herba Houttuyniae 400g, Fructus Mume 400g, Cortex Moutan 400g.

Boil the Radix Astragali, Herba Ephedrae, Fructus Mume, Herba Houttuyniae 2-3 time with decocting, each water yield be crude drug 8-12 doubly, filter merging filtrate.Steam distillation Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae, Flos Magnoliae, Cortex Moutan, the aqueous solution after obtaining volatile oil and distilling heats up in a steamer the back medicinal residues 2-3 time with 8-12 times of water gaging decoction, the aqueous solution after collecting decoction and the distillation.Two solution that obtain of step are further merged, add ethanol and make that to contain the alcohol amount be 70%, stir evenly, supernatant is got in cold preservation 24 hours, filters, and filtrate recycling ethanol is concentrated into dried cream, pulverizes the extract fine powder.Add suitable fine powder 1-2 doubly measure 5-15% ethyl cellulose ethanol liquid and quite fine powder 0.5-1 doubly measure magnesium stearate and volatile oil mixes, make microcapsule with compressed air by spray congealing.

3.7 aerosol

The Radix Astragali (processed with honey) 900g, Rhizoma Atractylodis Macrocephalae 400g, Radix Saposhnikoviae 400g, Herba Ephedrae 600g, Radix Angelicae Dahuricae 400g, Flos Magnoliae 400g, Cortex Moutan 500g, Herba Houttuyniae 400g, Fructus Mume 400g.

Get the Radix Astragali of ormal weight, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Fructus Mume, Radix Glycyrrhizae, Herba Houttuyniae, Flos Magnoliae and Cortex Moutan are pulverized, add 10-12 times of 60-70% alcohol reflux, merge extractive liquid,, filter, filtrate recycling ethanol, be concentrated into dried cream, get effective site, add 10～20% tween 80 alcoholic solution, 100～200 parts by volume, add 1 to effective site, 2-propylene glycol 200～300 parts by volume, mixing, it is fixed molten to 350～800 parts by volume to add ethanol, is sub-packed in the aerosol pressure bottle by 20-100ml, in every bottle, be pressed into dichlorodifluoromethane 1～10 weight portion behind the gland, make spray.

3.8 injection suspension

Radix Astragali 750g, Rhizoma Atractylodis Macrocephalae 250g, Radix Saposhnikoviae 250g, Herba Ephedrae 450g, Radix Angelicae Dahuricae 250g, Flos Magnoliae 250g, Herba Houttuyniae 250g, Fructus Mume 250g, Cortex Moutan 350g.

Get the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Fructus Mume, Radix Glycyrrhizae, Herba Houttuyniae, Flos Magnoliae and the Cortex Moutan of ormal weight and pulverize, the methanol dipping 72h with 8 times of amounts filters standby.Medicinal residues are put reflux, extract, twice in the water-bath with the ethanol of doubly measuring, each 2h, filter, medicinal residues merge above-mentioned filtrate and cleaning mixture with the methanol gradation washing of 2 times of amounts, 12h is left standstill in cold preservation, filters, in filtrate, by volume add 1% active carbon, stir 1h, filter, filtrate decompression reclaims methanol to there not being the alcohol flavor, concentrate, drying obtains effective site.

Get effective site 5g, emulsifying agent Ovum Gallus domesticus Flavus lecithin 35g and lipid myristin 25g, under logical condition of nitrogen gas, be heated to 80 ± 5 ℃, the aqueous solution that under stirring condition, adds uniform temp glycerol and poloxamer-188, make thick breast, carry 41.4MPa pressure stimulating milk secretion even 5 times with the high pressure dispersing emulsification machine under 80 ± 5 ℃ of logical condition of nitrogen gas, after the inflated with nitrogen packing, cooling forms the principal agent suspension rapidly, packing, promptly.

3.9 sugar free granule

The Radix Astragali (processed with honey) 800g, Rhizoma Atractylodis Macrocephalae 300g, Radix Saposhnikoviae 300g, Herba Ephedrae 500g, Radix Angelicae Dahuricae 300g, Flos Magnoliae 300g, Herba Houttuyniae 300g, Fructus Mume 300g, Cortex Moutan 400g, Radix Glycyrrhizae 300g.

Get the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae, Fructus Mume, Herba Houttuyniae and the Cortex Moutan of ormal weight and pulverize, decoct with water 2-3 time, each water yield is crude drug 8-12 times, filter, collecting decoction adds ethanol and makes and contain the alcohol amount and be 50-70%, stir evenly, supernatant is got in cold preservation 24 hours, filter, filtrate recycling ethanol is concentrated into the thick paste of 1.30-1.35, add an amount of excipient system soft material, granulate, sieve, granulate, pack.Every bag is equivalent to contain crude drug 6g.Consumption and usage: one day three times, each 2 bags.

4. the quality standard of medicament

4.1 check: (1) provides heavy metal, arsenic salt to check research data; (2) moisture, disintegration, content uniformity etc. are every checks by the pharmacopeia regulation.

4.2 differentiate: adopt thin layer chromatography to differentiate, and the thin layer chromatography color picture is provided.(1) Radix Angelicae Dahuricae is imperatorin, isoimperatorin; (2) Herba Ephedrae is an ephedrine hydrochloride; (3) Cortex Moutan is a paeonol; (4) Flos Magnoliae is a magnelin; (5) Radix Saposhnikoviae is 5-0-methyl visamminol glycosides, cimicifugoside; (6) Radix Glycyrrhizae is an ammonium glycyrrhizinate.

4.3 assay: adopt the HPLC method to measure the content of astragaloside in the Radix Astragali, and methodological study interrelated data and collection of illustrative plates are provided: (1) choice of experimental conditions (extracting solvent, extracting method, extraction time); (2) linear relationship is investigated; (3) blank assay; (4) stability test; (5) precision test; (6) replica test; (7) recovery test.

5. pharmacodynamics embodiment

5.1 antiinflammatory action

5.1.1 the assessment of the extract carrageenin pawl swelling experiment of Different Extraction Method preparation

Adopt plethysmometer (Plethysmometer 7150, Ugo Basile, Italy) to measure each animal median claw swelling volume (pressing ml), to the degree of accuracy of 2 significant digits mode.Before carrageenin injection and 2,4,6,24 hours afterwards, perhaps measured immediately in 1,2,3 and 4 hour after the protein injection.The swelling rate of pawl is the long-pending percentage difference of corpus unguis and is calculated by following formula: swelling rate (%)=(A-B) * 100/B, and it is long-pending that A represents to inject the corpus unguis of back different time points here, and the corpus unguis before B represents to inject is long-pending.Positive control drug is a dexamethasone, waits to try effective ingredient for what prepare by general extracting method and concrete extracting method I-VI, and material medicine is by weight: Radix Astragali 7g, Rhizoma Atractylodis Macrocephalae 4g, Radix Saposhnikoviae 4g, Herba Ephedrae 4g, Radix Angelicae Dahuricae 4g, Flos Magnoliae 4g.

Value representation is meansigma methods ± SD.Adopt the postmortem analysis of variance analysis (ANOVA) succeeded by LSD method (variance equates) or Tamhane ' s T2 method (variance does not wait), so that data evaluation, because the remarkable p of meaning＜0.05th on the statistics accepted.

The comparison (N=6) of table 1 extract antiinflammatory action in pawl swelling experiment

Group	Sample	Dosage (g/kg)	Stimulate the swelling percentage ratio (%) of rear solid end volume
							1 hour	2 hours	3 hours	4 hours
			A B C D E	No dexamethasone effective ingredient I effective ingredient II effective ingredient III	--- 8mg/kg 10 10 10	45.5±7.2 26.6±3.3 ^*** 33.6±11.1 ^* 39.8±7.6 ^# 40.9±10.0 ^##	1 hour	2 hours	3 hours	4 hours	35.9±6.7 19.3±5.8 ^*** 24.5±12.6 ^* 27.4±10.1 ^# 29.2±7.7 ^#	24.1±6.7 9.2±4.4 ^** 18.5±11.1 ^# 16.4±12.9 18.8±5.4 ^#	20.5±8.9 7.9±4.8 10.0±10.4 14.4±11.9 14.7±6.3

F G H G

Effective ingredient IV effective ingredient V effective ingredient VI effective ingredient VII

10 10 10 10

31.2±5.3 ^*** 29.8±7.5 ^*** 27.8±7.1 ^*** 40.3±10.4 ^#

20.5±2.4 ^** 16.9±7.8 ^*** 16.8±7.5 ^*** 24.7±8.8 ^*

14.6±3.7 ^* 13.2±6.5 ^* 8.4±8.27 ^*** 14.5±6.5 ^*

8.8±1.9 7.7±6.4 4.50±5.80 10.2±3.8

Note ^*P＜0.05, ^*P＜0.01, ^{* *}Comparison is put at one time with matched group in P＜0.001.#:P＜0.05, compare at one time with the IV group ##:P＜0.01.

Experimental data (table 1) shows that for the rat acute inflammation that is caused by the injection carrageenin, effective ingredient I-VII all has antiinflammatory action, and effective ingredient VI has the most effective antiinflammatory action.

5.1.2 medicine of the present invention, CN1368187A medicine, the experiment of the loyal medicine mice of Liu Mei caused by dimethylbenzene xylene ear swelling

Medicine material pharmaceutical formulation of the present invention is the Radix Astragali 9, the Rhizoma Atractylodis Macrocephalae 4, Radix Saposhnikoviae 4, the Radix Angelicae Dahuricae 4, Herba Ephedrae 6, Flos Magnoliae 4, Cortex Moutan 5.Preparation method is the described extracting method of method IV, makes effective ingredient.Two kinds of effective ingredient of preparation method preparation according to the loyal civilian described prescription of CN1368187A, Liu Mei are denoted as positive control 1,2.

Adopt the experiment of mice caused by dimethylbenzene xylene ear swelling.Get 40 of body weight 18～22g male white mouses, be divided into the blank group at random, and medicine group of the present invention (the 20g crude drug/kg), positive controls 1 and 2 (the 20g crude drug/kg).Continuous gastric infusion 7d, every day 1 time.1h after the last administration is coated with 20L1 caused by dimethylbenzene xylene inflammation at mouse right ear.Put to death animal behind the 1h.Card punch with bore 6mm is got sheet in the punching of mice left and right sides auricle same area, weighs, and it is heavy heavily to deduct left auricle with the auris dextra sheet, observes its swelling degree, the results are shown in Table 2.The result shows that medicine of the present invention and aspirin group all can obviously suppress mice ear, and medicine of the present invention is compared has antiinflammatory action preferably, and the result has significant difference.

The loyal medicine of table 22 medicine of the present invention, CN1368187A medicine, Liu Mei is to the influence of mice ear

Group	Dosage	Number of animals (only)	Ear swelling degree (m/mg)
Group	Dosage	Number of animals (only)	Ear swelling degree (m/mg)	Blank group positive control 1 positive control 2 medicines of the present invention	20ml (water) 20g crude drug/kg 20g crude drug/kg 20g crude drug/kg	10 10 10 10	11.2±2.4 9.0±2.2 9.3±2.5 6.8±2.3 ¹

Annotate: compare with matched group: ¹P＜0.05

5.2 the effect of screen nose relieving capsule resisting allergic rhinitis guinea pig model (the clinical hals,Nasen und Ohrenheilkunde magazine of reference 2003,17 (9) 557 pages)

All tests are generally established normal control group, model group, positive drug control group, are subjected to the large, medium and small metering group of reagent that (rat or Cavia porcellus: heavy dose of for clinical consumption 16 times, middle dosage are that 8 times, low dose are 4 times; Mice: heavy dose is 20 times of clinical consumption, and middle dosage is that 10 times, low dose are 5 times.Have additional description except.

5.2.1 set up the model of Cavia porcellus allergic rhinitis

With micro sample adding appliance 10% toluene, 2.4 toluene-2,4-diisocyanates (TDI), 10 μ l are splashed into the bilateral nasal cavity of Cavia porcellus respectively, every side 5 μ l, every day 1 time, 7d continuously, the next day of changing into then 1 time, totally 4 times; The matched group Cavia porcellus is then used physiologic saline for substitute 10%TDI collunarium.And the beginning drug treatment, model group and administration group gave 10%TDI 10 μ l nasal cavities in per 2 days and excite 1 time during the treatment, and matched group then sprays nose with 0.9%NaCl, continuous 4 weeks, 28d altogether.

5.2.2 main observation item and conclusion

Excite the back to observe animal 30min, statistics is scratched nose number of times and sneeze number at every turn;

Filter paper is measured the nose liquid measure;

The nasal secretion smear carries out the EOS counting;

Nasal mucosa is crossed the mensuration of sensitive media: after last excites, defend barbital intraperitoneal injection anesthesia (40mg/kg) with 1%, then with the animal sacrificed by decapitation, get the 150mg bronchia mucosal, measure the content of histamine and LTB4 in the supernatant after the homogenate;

Pathological study: it is fixing that bronchia mucosal is put into 10% formaldehyde, paraffin embedding, section, row hematoxylin-eosin staining.Light microscopic is observed down.

Conclusion: screen nose relieving capsule can significantly suppress the development of Cavia porcellus allergic rhinitis.

5.3 the effect of screen nose relieving capsule Chinese People's Anti-Japanese Military and Political College Mus allergic rhinitis model (with reference to journal of Zhejiang university medicine calendar year 2001,3 (6), 276 pages)

5.3.1 set up the model of rat allergic rhinitis

The etherization rat, (every milliliter contains ovalbumin 1mg, bordetella pertussis 10 to inject the antigen adjuvant suspension of 0.1ml and 0.2ml respectively in rat left and right sides forelimb and hind leg sole of the foot portion ¹⁰Individual and aluminium hydroxide 2mg) carries out sensitization.Strengthen sensitization behind the first sensitization 5d, the 0.5mg ovalbumin is dissolved in the 1ml normal saline injects rat back.First sensitization 7d begins to use once a day ovalbumin 1g/L collunarium, each 10 μ l.And, every 7d ovalbumin normal saline solution 1g/L10 μ l collunarium.Continuous 4 weeks, 28d altogether.

5.3.2 main observation item and conclusion

Ovalbumin is attacked and to be scratched nose number of times and sneeze number in the 30min of back;

Nasal secretion smear and nasal mucosa are crossed sensitive media and are measured the same;

Egg protein specificity lgE tires;

The nasal mucosa histopathology changes.

Conclusion: screen nose relieving capsule can significantly suppress the development of rat allergic rhinitis.

5.4 screen nose relieving capsule is to the effect of rat allergic rhinitis model mastocyte membrane stability

The degranulated experimental technique of sensitization rat hypertrophy cell (form method): sensitization rat carotid artery sacrificed by exsanguination, use Hank ' s liquid flushing abdominal cavity, collect peritoneal irrigation liquid, place plastic test tube (above test procedure is all carried out) under 4 ℃.The centrifugal 5min of 500 * g gets supernatant.Precipitation shakes up with appropriate amount of buffer solution, is rat abdominal cavity MC suspension.Use the centrifugal 10min of Hank ' s liquid 1000rpm to wash once, abandon supernatant, precipitate is resuspended in 2～3ml Hank ' s liquid, put in the ice bath standby.Get 1～2 of dimethyl diaminophenazine chloride and strong that green mixed dye on slide, at room temperature natural drying is standby.Get 1 of above-mentioned resuspended liquid and drip on the slide that dyestuff is arranged, the jog slide makes it mix homogeneously, puts 37 ℃ of incubator 3min, examines under a microscope the mast cell degranulation situation, relatively is subjected to the difference of examination group and matched group.

Conclusion: be subjected to examination group result to be better than matched group, significant difference is arranged, screen nose relieving capsule can significantly suppress the development of rat allergic rhinitis.

5.5 the influence that screen nose relieving capsule increases the mice capillary permeability due to the histamine

Mice administration 3 days, last administration 1h postabdomen intradermal injection 300 μ l/ml histamine phosphates (20 μ l/ are only), the blue 10ml/kg of tail vein injection 0.5% she Wen immediately, put to death behind the 20min, peel off the skin locus coeruleus, shred, colorimetric method for determining dyestuff seepage discharge (μ l/ml).

Conclusion: be subjected to examination group result to be better than matched group, significant difference is arranged, screen nose relieving capsule has anti-histamine activity.

5.6 medicine of the present invention is to the effect of passive cutaneous anaphylaxis, PCA

5.6.1 screen nose relieving capsule is to the influence of Cavia porcellus ear xenogenesis passive cutaneous anaphylaxis, PCA

Give the injection of rat sole with Radix Trichosanthis gel aluminum hydroxide suspension, each sole injection 0.1ml after 10-15 days, puts to death the rat separation of serum.Get healthy guinea pig, two auricles are respectively injected rat anti serum 20 μ l.Carry out antigen behind the 48h and attack, the blue solution of tail vein injection 0.25ml 0.25% ivens includes Radix Trichosanthis 0.25mg.0.5h after Cavia porcellus is put to death, cut auricle.Two auricles place in vitro, add 0.75ml 1mol/L KOH solution, and 37 spend digestion at night, add 3.5ml 0.2molH then ₃PO ₄Solution and acetone mixed liquor (5: 13), centrifugal after extracting, supernatant is measured trap with 640nm.Measure suppression ratio.

5.6.2 the influence that medicine of the present invention, CN1368187A medicine, the loyal medicine of Liu Mei react models of passive skin irritability of rats

Medicine material pharmaceutical formulation of the present invention is the Radix Astragali 8, the Rhizoma Atractylodis Macrocephalae 3, and Radix Saposhnikoviae 3, the Radix Angelicae Dahuricae 3, Herba Ephedrae 5, Flos Magnoliae 3, Cortex Moutan 4 preparation methoies are the described extracting method of method IV, make effective ingredient.Two kinds of effective ingredient of preparation method preparation according to the loyal civilian described prescription of CN1368187A, Liu Mei are denoted as positive control 1,2.

At first prepare antiserum: get male rat, body weight 150～200g, every side leg muscle inject 1% egg protein normal saline 0.5ml, subcutaneous injection 4% gel aluminum hydroxide 0.1ml, and disconnected neck is got blood behind the 14d, centrifuging and taking serum, it is standby to put-4 ℃ of refrigerators.Male rat of the same race is divided into matched group at random, medicine of the present invention, CN1368187A medicine, three groups of the loyal medicine of Liu Mei, positive controls.Continuous irrigation appetite clothes 14d.Hair was shaved at the back in the 15th day, made the back intradermal injection with the antiserum of dilution in 1: 10.Every side 2 points, every some injection 0.1ml.Behind the 24h, every rat tail vein is injected 2% azovan blue, 2% each 0.5ml of egg protein normal saline.Put to death rat behind the 30min, cut the skin that has locus coeruleus.Place to fill 4ml acetone normal saline (7: 3) and in vitro soak 48h, centrifugal back supernatant is measured optical density (OD) with spectrophotometer and is worth in 610nm place.

The protective effect comparative study of table 3 pair models of passive skin irritability of rats reaction

Group	Dosage	Number of animals (only)	Absorbance (OD)
Group	Dosage	Number of animals (only)	Absorbance (OD)	Blank group positive control 1	20ml (water) 10g crude drug/kg	10 10	0.414±0.133 0.321±0.073

Positive control 2 medicines of the present invention

10g crude drug/kg 10g crude drug/kg

10 10

0.315±0.072 0.235±0.07 ¹

Annotate: compare with matched group ¹P＜0.05

Conclusion: be subjected to examination group result to be better than matched group, significant difference is arranged, medicine of the present invention can effectively suppress passive cutaneous anaphylaxis, PCA, and rat is had obvious protective effect.

5.7 screen nose relieving capsule is to the influence of mouse immune reaction

Research screen nose relieving capsule is to normal effect of immunologic function: to the influence of Turnover of Mouse Peritoneal Macrophages phagocytic function, to the influence of mice T, B cell proliferation, to the influence of mice delayed hypersensitivity etc.; To allergic rhinitis rat model Immune Effects: index is the same.

Conclusion, screen nose relieving capsule can strengthen immune function of mice.

5.7.1 influence to mice reticuloendothelial system (RES) phagocytic function

Get 50 of body weight (18-22) g mices, water is can't help in experiment fasting the previous day, is divided into 5 groups during test at random, and 10 every group, male and female half and half.Negative control group gavages 0.5%CMC liquid 0.2ml/10g; Positive controls gavages levamisole 2.5mg/kg; The test drug group gavages medicine of the present invention, CN1368187A medicine, the loyal medicine of Liu Mei respectively, and each group gavages 8d, every day 1 time continuously.The 8th day behind administration 30min, the india ink 0.5ml/10g of every caudal vein injection dilution, in 1,5min gets blood 20L1 from the eye socket vein respectively, shake up in the adding 2ml0.1%Na2CO3 solution,, calculate and clean up index k with 721 type spectrophotometers colorimetric photometry density under 680nm, after this get the Mouse Liver spleen and weigh, calculate activate the phagocytic capacity a.

The influence of table 5 pair mice reticuloendothelial system phagocytic function

Group	Dosage g/kg	k	a
Group	Dosage g/kg	k	a	Negative control levamisole positive control 1 medicine positive control 2 of the present invention	0.0025 2 2 2	0.0121±0.0036 0.0220±0.0046 ² 0.0157±0.0032 0.0211±0.0047 ² 0.0171±0.0052 ¹	2.6375±0.318 3.6421±0.132 ² 2.8762±0.365 3.5064±0.334 ² 3.1485±0.476 ¹

Annotate: n=10 and matched group ratio ¹P＜0.05, ²P＜0.001

As seen from Table 5, with the negative control group ratio, medicine of the present invention and positive control drug levamisole and 1 and 2 all have the effect of obvious enhancing mice RES phagocytic function, medicine of the present invention and levamisole effect are the most remarkable, positive control drug 1 and 2 effects are more obvious, but not as the former two, positive control drug 1 effect is than a little less than 2, and medicine of the present invention is compared with 2 with positive control drug 1 also significant difference.

5.8 the toxicology of screen nose relieving capsule treatment of allergic rhinitis

5.8.1 acute toxicity test

Measure LD50,, then measure the mice maximum dosage-feeding: medicine is made into maximum concentration, 2～3 times/every day of mice 0.4ml/10g body weight, each 5～6 hours at interval, observation 14 days continuously after the administration if surveys to go out dead dosage.Calculate one day dosage, be equivalent to the multiple of people's consumption.

Capsule was not found mortality rate on the 14th after with 294g medical herbs/single administration of kg dosage.Compare with matched group,, slight minimizing is arranged on weight increase on 3rd and 5.Equally, on 2nd and 4, appetite had slight reduction.In a week behind the drug administration, these indexes recover gradually.

5.8.2 long term toxicity test

Experiment 40 every group, divides large, medium and small three dosage groups and matched group with Wistar rat or SD rat.Dosage: heavy dose is 60 or 80 times of people's consumption, 30 or 40 times of middle dosage behaviour consumption, low dose of for people's consumption 15 or 20 times, administration time is to decide according to clinical course of treatment (6 months), carries out the observation of relevant index by declaring the new requirement of new drug.

Conclusion: screen nose relieving capsule is safely and effectively.

5.9 screen nose relieving capsule treatment clinical observation on allergic rhinitis

This clinical observation purpose is to inquire into the therapeutical effect of screen nose relieving capsule to allergic rhinitis.

Method is selected 120 routine allergic rhinitis patients, at random case is divided into treatment group and matched group.Treatment group, each 60 example of matched group give the treatment of screen nose relieving capsule and chlorphenamine respectively.Observing the symptoms before and after the treatment comprises sneeze, watery nasal discharge, nasal obstruction and rhinocnesmus, and carries out rank scores, observes simultaneously to have or not obvious adverse reaction during patient takes screen nose relieving capsule.

Sneeze, watery nasal discharge, nasal obstruction and rhinocnesmus symptom all have clear improvement (P＜0.05) before and after the treatment group as a result treatment, and obvious effective rate and total effective rate also are higher than matched group (P＜0.05).Period in a medicine is not seen tangible untoward reaction.

Conclusion screen nose relieving capsule has advantages such as good effect, no obvious toxic-side effects, is the ideal medicament of treatment allergic rhinitis.

5.9.1 object of study and method

Object of study

Case source is traditional Chinese medical science hall traditional chinese medical science clinic of Beijing University of Chinese Medicine in March, 2003～2005 year 3 moon gates people that diagnoses a disease.The patient is a perennial onset, has sneeze (each continuous more than 3), snivel and 3 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 surpasses 0.5h in 1 day, and the course of disease at least 1 year.All patients all keep the score [1] according to the diagnostic criteria of Society of Ophthalmology of China's revision in 1997, are defined as the perennial allergic rhinitis.

Exclusion standard:

(1) in, the severe asthma patient; (2) serious nose hyperemia, vasomotor rhinitis patient; (3) obstructive nasal polyp or upper respiratory tract history of operation patient in the recent period; (4) suffers from serious illness patient such as severe cardiac, lung, liver, brain simultaneously; (5) patient of use hormone or other Claritins in treatment the last fortnight; (6) can not adhere to that medication also comes the case and the full person of clinical data of further consultation weekly.

Totally 120 routine patients are divided into case treatment group and matched group at random.Wherein, 60 examples are organized in treatment, male 32 examples, women 28 examples, 15～46 years old age, average (29.2 ± 5.1) year, the course of disease (4.8 ± 2.6) year; Matched group 60 examples, male 27 examples, women 33 examples, 16～45 years old age, average (28.7 ± 5.4) year, the course of disease (4.5 ± 2.3) year.The symptom and sign classification difference of always keeping the score does not have significance (P＞0.05) before two groups of patient ages, sex, the course of disease and treatments.

5.9.2 Therapeutic Method

Withdraw the Chinese medicine and western medicine that other have anti-allergic effects during the treatment, treatment group institute is a screen nose relieving capsule of the present invention to medicine, screen nose relieving capsule Main Ingredients and Appearance is: Chinese medicines such as the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, Herba Ephedrae, the Radix Angelicae Dahuricae, Flos Magnoliae, Herba Houttuyniae, Cortex Moutan, Radix Glycyrrhizae, Fructus Mume, specification 0.5g/ grain, take 4～5 at every turn, 3 times/day, 7 days 1 courses of treatment, take 4 courses of treatment altogether; The oral chlorphenamine 4mg of matched group, 1～3 time/day, administration time is with the treatment group.

Lab testing such as row allergen skin experiment and nasal discharge eosinophilic granulocyte before the patient treatment, after the treatment.Check weekly during the medication, recording medicine situation and symptom variation and nasal cavity are checked situation, and keep the score, integration before and after the statistics treatment after treatment finishes.

5.9.3 observe the symptoms and keep the score

Symptom classification and keeping the score sees Table 1

The table 1 allergic rhinitis symptom classification standard of keeping the score

Classification is kept the score	Sneeze (one-time continuous number)	Watery nasal discharge (blowing the nose number of times every day)	Nasal obstruction	Rhinocnesmus
Classification is kept the score	Sneeze (one-time continuous number)		Nasal obstruction	Rhinocnesmus	1 minute 2 minutes 3 minutes	3～9 10～14 ≥15	≤4 5～9 ≥10	Almost whole day mouth breathing falls between by chance	Be interrupted the sense of ant row, but can stand the sense of ant row, unbearably

Sign classification and keeping the score

At the bottom of concha nasalis inferior and the nose, nasal septum near, can not see middle nasal concha, or middle nasal concha mucosal polyp sample becomes, polyp forms, and is recorded as 3 fens; Concha nasalis inferior and nasal septum (or at the bottom of nose) near, small gap is still arranged between (or nasal septum) at the bottom of concha nasalis inferior and the nose, be recorded as 2 fens; Still as seen concha nasalis inferior mild swelling, nasal septum, middle nasal concha are recorded as 1 fen.

Safety observation

General physical examination project: whether blood, urine, just routine examination have or not the discovery obvious adverse reaction in the observation patient drug administration process, and can adhere to taking medicine the unusual circumstance immediate record.

5.9.4 therapeutic evaluation

According to the summation that sings and symptoms before and after the treatment is kept the score, the percentage rate of improvement is by following formula evaluation perennial allergic rhinitis's curative effect ^[1]:

Total points * 100% before (total points before the treatment-treatment back total points) ÷ treatment

〉=51% is produce effects, and 50%～21% is that effectively≤20% is invalid.

5.9.5 statistical procedures

Adopt the SPSS11.0 software kit that statistical data is handled, relatively adopt the check of pairwise correlation sample before and after self treats in the group, relatively adopt the t check between group.

5.9.6 therapeutic outcome

60 routine allergic rhinitis patients are organized in treatment, produce effects 33 examples (55%) wherein, effective 19 examples (31.67%), invalid 8 examples (13.33%), total effective rate 86.67%; Matched group 60 routine allergic rhinitis patients, produce effects 20 examples (33.33%) wherein, effective 22 examples (36.67%), invalid 18 examples (30%), total effective rate 70%.Own control significant difference (P＜0.01) before and after treatment group and the treatment of control group.Treatment group treatment back total mark, allergen skin experiment and nasal discharge eosinophilic granulocyte testing result all obviously are better than matched group, and indexs such as obvious effective rate, total effective rate are apparently higher than matched group (P＜0.01).The results are shown in Table 2,3,4.Blood in the treatment group therapeutic process, urine, just routine examination is all in normal range, and matched group many cases patient reflects during the medication that untoward reaction such as drowsiness, thirsty, sleepy are arranged.The clinical practice of safety observed result prompting screen nose relieving capsule does not have obvious toxic-side effects.

Symptom, the sign classification variation (x ± s) that always keeps the score before and after the table 2 liang group patient treatment

Group	The example number	Symptom, sign classification are always kept the score
		Symptom, sign classification are always kept the score		Before the treatment	After the treatment
		Treatment group matched group	60 60	Before the treatment	After the treatment	11.83±1.35 11.36±1.27	5.02±1.51 ^△△ 7.19±1.88 ^

Annotate: relatively preceding with treatment ^*P＜0.01; Compare with matched group ^{△ △}P＜0.01

Lab testing variation before and after the table 3 liang group treatment (x ± s)

Group	The example number	The positive reaction of allergen skin experiment		The nasal discharge eosinophilic granulocyte positive
		The positive reaction of allergen skin experiment		The nasal discharge eosinophilic granulocyte positive		Before the treatment	After the treatment	Before the treatment	After the treatment
		Treatment group matched group	60 60	60 60	9 ^△△ 19 ^	Before the treatment	After the treatment	Before the treatment	After the treatment	60 60	10 ^△△ 21 ^

Show by table 2,3, symptom, sign classification are always kept the score after treatment group and the treatment of control group, compared remarkable reduction before allergen skin experiment and nasal discharge eosinophilic granulocyte testing result and the treatment, and treatment group symptom, sign classification are always kept the score, and allergen skin experiment and nasal discharge eosinophilic granulocyte detect positive findings and be starkly lower than matched group.

Table 4 demonstration, treatment group and matched group show that at aspect significant differences such as produce effects, total effective rates screen nose relieving capsule is better than chlorphenamine to the therapeutical effect of allergic rhinitis.

Table 4 liang group curative effect comparison (x ± s)

Group	The example number	Produce effects		Effectively		Invalid		Total effective rate
		Produce effects		Effectively		Invalid		Total effective rate		The example number	％	The example number	％	The example number	％	The example number	％
		Treatment group matched group	60 60	33 20	55％ ^** 33.33％	19 22	31.67％ 36.67％	8 18	13.33％ ^** 30％	The example number	％	The example number	％	The example number	％	The example number	％	52 42	86.67 ^** 70％

Annotate: compare with matched group ^*P＜0.01

5.9.7 discuss

Allergic rhinitis are that susceptible individual (idiosyncrasy) contacts the release of the inflammatory mediator that comprises the IgE mediation that causes behind the sensitization allergen and the nasal mucosa chronic inflammation disease that panimmunity competent cell, cytokine participate in, and belong to the I allergic reaction type.The patient mostly is allergic constitution, and anaphylactic disease takes place easily, is the basic reason that causes the allergic rhinitis pilosity, easily sends out.Doctor trained in Western medicine mainly contains the treatment measure of primary disease and avoids contacting allergen, Drug therapy, immunization therapy etc., but these treatment measures exist be difficult to adhere to, side effect is big, lost efficacy easily, easily recurrence etc. is obviously not enough ^[2,3], lack at the basic effective means of disease, can't allow extensive patients please oneself.

Allergic rhinitis belong to Chinese medicine " allergic rhinitis " category, and it is a primary symptom with ictal sneeze, snivel, nasal obstruction and rhinocnesmus.Perennial allergic rhinitis patient also accompanies and sees ophthalmic pruritus.We think the generation endogenous cause of ill natural endowment special (allergic constitution) of this disease, the invasion and attack of exopathogenic factor " wind, cold, heresy ", and both are indispensable, influence each other.Its sick position is at nose, and it is dirty to concern lung, spleen, kidney three, and the state of an illness is a deficiency in origin and excess in superficiality, but that the generation of primary disease, development and the state of an illness lapse to the functional status of lung is in close relations.Nose is the key of lung, " lung-QI connecting with the nose, lung and then nose can know good and foul smells gas ".If insufficiency of lung-QI, instability of surface, then pathogen such as wind and cold is taken advantage of a weak point, and struggle between vital QI and pathogen eliminating evilly goes out then that rhinocnesmus, sneeze are done frequently; Pathogen resistance lung, impairment of purifying function of the lung, gas is not taken the photograph Tianjin, and body fluid is excessive, and then thin nasal discharge is continuous, and body fluid is stopped up the resistance nasal cavity, and then the swelling of intranasal mucosa is pale, and nasal obstruction is obstructed.Therefore we think that its basic pathogenesis is an insufficiency of lung-QI, and wind and cold is violated nose, and the resistance key is held back lung, and the rule of treatment should be with benefiting QI for strengthening the superficies, a surname's clearing the nasal passage.We are used for the lung deficiency of defensive qi, allergic rhinitis due to ailment said due to cold or exposure is attacked, and disease is seen rhinocnesmus, sneeze, nasal obstruction, snivel, anemophobia spontaneous perspiration; Allergic rhinitis are seen above-mentioned patient.

The multi-flavor medicine has immunosuppressive action in the modern pharmacology proof side, and Herba Ephedrae epheday intermedia fruit polysaccharide can obviously suppress macrophage phagocytosis of mice ^[4], isolating Herba Ephedrae in Herba Ephedrae _-9905Can inhibitory action be arranged to the cellular immunization of mice ^[5]Semen Armeniacae Amarum liquid can reduce the sensitivity that guinea pig trachea stimulates ammonia, to the excitation to guinea pig tracheal smooth muscle and intestinal smooth muscle of antihistamine, acetylcholine, barium chloride, tangible antitussive action is arranged and strengthen the effect of intestinal peristalsis ^[6]Radix Scutellariae, Flos Magnoliae all increase capillary permeability due to the histamine very significantly antagonism ^[7]Radix Scutellariae can suppress antigen and combine with IgE, reduces antigen antibody reaction.CAMP level in the rising cell, and the generation of inhibition leukotriene chemical compound, thus anaphylaxis suppressed ^[8]

Flos Magnoliae volatile oil shrinks the guinea pig ileum anaphylaxis due to SRS-A (slow reacting substance), histamine, the acetylcholine remarkable antagonism, and can obviously stop rat hypertrophy cell to take off granule ^[9,10]The IgE that the Fructus Xanthii water decoction can significantly suppress sensitized mice produces, the I type allergy that postpones and alleviate the egg protein sensitized guinea pig, and the pair cell immunity has inhibitory action ^[11]The Bulbus Lilii aqueous extract has anti-allergic effects, the Bufo siccus asthma that can cause antihistaminic ^[12]Isoliquiritigenin in the Radix Glycyrrhizae and glycyrrhizin all have inhibitory action to the active of hyaluronidase with by the inductive mastocyte histamine release of immunostimulation ^[13]

Clinical observation shows, screen nose relieving capsule can play a role on a plurality of links of allergy and mechanism, inherent biased adjusting the to allergic constitution, adjust the disorder of body immune system, remove deleterious allergy, change patient's allergic constitution, natural environment is become discomfort should be adaptation, fundamentally solve unusual allergic generation.And the clinical practice of screen nose relieving capsule do not see obvious toxic-side effects, and patient's well-tolerated can adhere to taking medicine for a long time, so screen nose relieving capsule has broad application prospects in the treatment allergic rhinitis.

Treatment is known from experience recognizes us, and the blocking-up pollinosis is to the development of perennial allergic rhinitis even asthma, and early stage thorough treatment is necessary.And the high incidence of allergic rhinitis points out our allergic rhinitis to be not only medical care problem, but social problem.Because it not only influences patient's Health and Living quality, and diagnosis and treatment expense costliness.This disease can not only influence patient's sleep quality, also can cause hyposmia, throat pain, absent minded, hypomnesis, headache and serious sniffle, and emotion is produced harmful effect, and daily life and society's communication are restricted.

Treating both the principal and secondary aspects of a disease is answered in the treatment of allergic rhinitis, and based on controlling symptoms, the catabasis should be with strengthening the body resistance at acute attack stage, and it is main improving allergic constitution.Paracmastic treatment was decided to be 3 months 1 course of treatment, adhered to treating 1～4 course of treatment, can improve allergic constitution, the outbreak once more that prevents and palliate a disease, and patient should strengthen physical training in the catabasis simultaneously, and health invigorating is given up bad habit such as smoking etc.In a word, we think that Chinese medicine is having special advantages aspect the treatment of anaphylactic disease, should further go deep into systematic research and exploitation.

Variation in the scope of the invention

According to the constraint of traditional Chinese medical science practice and Pharmacopoeia of People's Republic of China, in order to use usually preferred dried plant raw material.Therefore, all weight that relate to medical herbs of above description are dry weights of those medical herbs.Though tradition is used and preferred dried feed, must recognize that exsiccant plant material promotes their storage, transportation and processing subsequently.Drying is not that to obtain these medical herbs advantages necessary.Thereby, also can implement the present invention with the fresh plant raw material of listing.The use of fresh plant raw material is enough to meet the necessary quality and the ratio of the extract of use, is included in the scope of the present invention.

The indivedual plant bars of pharmacopeia have provided several kinds now in a plant belongs to, this is understandable.Other member's free substitution of the same genus that these of same genus kind can be provided by pharmacopeia perhaps uses together.

In addition, people recognize that a certain plant parts can contain the interested active component of higher concentration, and the present invention instructs under officinal standardized denomination and uses specific plant parts.Yet these compositions can also be positioned at other position of same plant.Thereby interested composition can extract from other position of same plant in the scope of current claims.It will be appreciated by those skilled in the art that by means of plant cell and tissue culture technique the cell of these medical herbs of In vitro culture and tissue and to make the interested active component of tissue extraction from these cells be feasible.

Extracting method need reduce the size of medical material.Here, can include, but not limited to cut, mince, shred, smash to pieces, pulverize, mill and grind, finish reducing of size by many modes.Though instructed a kind of mode, can also be used to complete other ways and means that the medical material size reduces.

Although embodiment preferred has only been described in the invention through illustrating and having described in detail the front for the embodiment for the purpose of the clear understanding.Can be undertaken some by it does not deviate from and describes and the variation and the correction of the spirit and scope of claimed those.Utilize above explanation, the skilled person in the Chinese herbal medicine preparation and the field of use can easily implement method of the present invention.For example can adopt orthogonal experiment method and relative method to carry out by extraction time, time, amount of water to the correction of water extraction process; Correction to alcohol extraction technology can adopt orthogonal experiment method and relative method to carry out by determining alcohol, extraction time, alcohol adding amount, extraction time.

List of references:

1. Chinese Medical Association's otolaryngology branch, Chinese hals,Nasen und Ohrenheilkunde magazine editorial board. diagnosis of allergic rhinitis and efficacy assessment standard. Chinese hals,Nasen und Ohrenheilkunde magazine, 1998,33 (3): 134

2. all soldiers, Li Huabin. the allergic rhinitis Progress in diagnosis and treatment. People's Armed Police's medical science, 2003,14 (6): 323-325

3. Ye Shitai edits. allergology. and Beijing, Science Press, 1998:426-431

4. Sun Li, Cheng Jianzhen, Liu Chunxia, etc. Herba Ephedrae fruit polysaccharide is to effect of immunologic function. Zhangjiakou Medical College journal, 2000,17 (4): 11

5. bright, Zhu Gengxin, Xu Zhiyin of Chen Rong. the influence of different extract pair cell immunity in the Herba Ephedrae. Nanjing University of Traditional Chinese Medicine's journal (natural science edition), 2001,17 (4): 234-236

6. Lee Deqing. the aqua armeniacae extracting solution is to cough-relieving, the defecating feces excretion research of laboratory animal. Chinese basic unit medicine, 2003,10 (10): 1001-1002

7. yellow refined English, Chen Jiapei, Wang Guangyi. the anti-allergic effects of Chinese medicines such as Fel Ursi and Flos Magnoliae. Pharmacology and Clinics of Chinese Materia Medica, 1996,3:28-29

8. golden haze, Jin Ruomin. newly organized pharmacology of Chinese materia medica and clinical practice. Shanghai: Shanghai scientific and technical literature publishing house, 1995.194

9. old refined jade-like stone, Zhou Daxing. the antiinflammatory of Flos Magnoliae volatile oil, anti-allergic effects. contemporary Chinese is used pharmacy, 1998,15 (2): 7-9

10. Li Xiaoli, Zhang Yongzhong. the antiallergic experimentation of Flos Magnoliae volatile oil. Chinese Hospitals pharmaceutical journal, 2002,22 (9): 520-521

11. left ancestral's English, Tang Enjie, the summer Jianping, etc. Radix Saposhnikoviae Fructus Xanthii water decoction is to effect of immunologic function. Chuanbei Medical College's journal, 1997,12 (3): 9-10

12. Gao Xuemin chief editor. Chinese materia medica. Beijing: China Traditional Chinese Medicine Publishing House, 2002.569

13.Kakegawa H，Watsushima H，satoh T，Inhibitory effects of some natural products on the activationof hyaluronidase and their anti-allergic actions.Chem Parm Bull，1992，40(6)：1439

Claims

1, a kind of compositions that prevents and/or treats allergic rhinitis, allergic rhinitis, it is made up of the effective ingredient and the pharmaceutically acceptable carrier of raw material of Chinese medicine preparation, in weight portion, raw material of Chinese medicine comprises the component of following weight portion: Radix Astragali 7-9, Rhizoma Atractylodis Macrocephalae 2-4, Radix Saposhnikoviae 2-4, Radix Angelicae Dahuricae 2-4, Herba Ephedrae 4-6, Flos Magnoliae 2-4, Cortex Moutan 3-5.

2, compositions as claimed in claim 1, it is characterized in that described effective ingredient is prepared through following method by described proportion raw material: the raw material of Chinese medicine of getting ormal weight, boil the Radix Astragali, Herba Ephedrae 2-3 time with decocting, collecting decoction filters, is concentrated into thick paste, prepares dried cream A; With the alcohol reflux Radix Angelicae Dahuricae, to get extracting solution and reclaim ethanol, concentrate drying prepares dried cream B; Steam distillation Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae, Flos Magnoliae, volatile oil C, filter medicinal residues C1, water extract C2; The steam distillation Cortex Moutan, extract Aromatic water place paeonol crystallization D, filter water extraction medicinal residues D1, water extract D2; Water extraction D1 and C1 2-3 time get decocting liquid E; C2, D2 and E merge, and concentrate, and precipitate with ethanol filters, and concentrate drying prepares dried cream F; A, B, C, D and F mix, and promptly get effective ingredient.

3, compositions as claimed in claim 1 is characterized in that raw material also comprises Herba Houttuyniae 2-4 weight portion, Fructus Mume 2-4 weight portion.

4, a kind of compositions that prevents and/or treats allergic rhinitis, allergic rhinitis, it is made up of the effective ingredient and the pharmaceutically acceptable carrier of raw material of Chinese medicine preparation, in weight portion, raw material of Chinese medicine is: Radix Astragali 7-9, Rhizoma Atractylodis Macrocephalae 2-4, Radix Saposhnikoviae 2-4, Radix Angelicae Dahuricae 2-4, Herba Ephedrae 4-6, Flos Magnoliae 2-4, Cortex Moutan 3-5, Herba Houttuyniae 2-4 weight portion, Fructus Mume 2-4 weight portion, Radix Glycyrrhizae 2-4 weight portion.

5, compositions as claimed in claim 4 is characterized in that in each proportion of raw materials of weight portion being: the Radix Astragali 8, the Rhizoma Atractylodis Macrocephalae 3, Radix Saposhnikoviae 3, Herba Ephedrae 5, the Radix Angelicae Dahuricae 3, Flos Magnoliae 3, Herba Houttuyniae 3, Fructus Mume 3, Cortex Moutan 4, Radix Glycyrrhizae 3.

6, as any one the compositions of claim 1-5, it is characterized in that the Radix Astragali is a processed with honey.

7, compositions as claimed in claim 6, the dosage form that it is characterized in that it are any pharmaceutically acceptable dosage forms.

8, compositions as claimed in claim 7 is characterized in that it is powder, syrup, granule, oral liquid, hard capsule, soft capsule, tablet, aerosol, microcapsule, injection suspension or pill.

9, compositions as claimed in claim 8 is characterized in that it is a hard capsule.

10, preparation of compositions method as claimed in claim 9, it is characterized in that it comprises following processing step: get ormal weight raw material Radix Astragali (processed with Mel), the Rhizoma Atractylodis Macrocephalae, Radix Saposhnikoviae, the Radix Angelicae Dahuricae, Herba Ephedrae, Flos Magnoliae, Herba Houttuyniae, Cortex Moutan, Fructus Mume and Radix Glycyrrhizae, boil the Radix Astragali, Herba Ephedrae, Fructus Mume, Radix Glycyrrhizae, Herba Houttuyniae 2-3 time with decocting, collecting decoction filters, is concentrated into thick paste, prepares dried cream A; With the alcohol reflux Radix Angelicae Dahuricae, to get extracting solution and reclaim ethanol, concentrate drying prepares dried cream B; Steam distillation Radix Saposhnikoviae, the Rhizoma Atractylodis Macrocephalae, Flos Magnoliae, volatile oil C, filter medicinal residues C1, water extract C2; The steam distillation Cortex Moutan, extract Aromatic water place paeonol crystallization D, filter water extraction medicinal residues D1, water extract D2; Water extraction D1 and C1 2-3 time get decocting liquid E; C2, D2 and E merge, and concentrate, and precipitate with ethanol filters, and concentrate drying prepares dried cream F; A, B, F merge crushing screening and get medicated powder, and paeonol D is ground into fine powder, and equivalent incremental method and above-mentioned medicated powder merge mixing, and volatile oil C adds 95% dissolve with ethanol, sprays into above-mentioned medicated powder, mixing; The system soft material is granulated, granulate, and the hard capsule of packing into, promptly.