A kind of pharmaceutical composition and preparation method thereof for treating allergic rhinitis
Technical field
The present invention relates to a kind of pharmaceutical compositions and preparation method thereof, specifically, are related to a kind for the treatment of allergic rhinitis
Pharmaceutical composition and preparation method thereof.
Background technology
Allergic rhinitis, that is, allergic rhinitis refers to after atopic individuals contact allergen, mainly by the medium of IgE mediations
(Mainly histamine)Release, and there are many schneiderian membrance non-infectious inflammatory diseases of the participations such as immunocompetent cell and cell factor
Disease.Its necessary condition occurred has 3:Specific antigen is the substance for causing organism immune response;Atopic individuals, that is, so-called
Individual difference, allergic constitution;Specific antigen answers both type individuals to meet with spy.Allergic rhinitis are that a global health is asked
Topic, can lead to many diseases and disability.
Allergen is inducing specific IgE antibody and the antigen that reacts therewith.They mostly from animal, plant,
Insect, fungi or occupational substance.Its ingredient is protein or glycoprotein, and only a few is polysaccharide.Allergen is broadly divided into suction
Entering property allergen and food-consuming structure.The main reason for inhalant allergen is allergic rhinitis.
Mite is dermatophagoides pteronyssinus, dust mite etc. in the most important mite in subtropical zone and torrid areas.Dermatophagoides pteronyssinus is food with mankind's scurf,
And it mainly lives in mattress, bed bottom, pillow, carpet, furniture and push toy.In heat(20 DEG C or more)And it is moist(It is relatively wet
Degree is more than 80%)Environment in breed it is most fast.Dermatophagoides pteronyssinus allergen is included in its fecal pellets, when the fabric of contamination is touched
After dynamic, these particles are just exposed in air and can deposit again quickly.Mite allergen concentration in air and allergic effect
The morbidity of property rhinitis is related.
Pollen anemophilous pollen can be influenced since the amount of drifting is huge and can transmit at a distance far from pollen source several hundred kilometers
Crowd.Entomophila pollen is only in direct contact just meeting sensitization, such as agronomist and florist's shop salesman.The sensitizability of pollen with season,
Geographical location, temperature and floristics and change.Most of pollen sensitization persons can suffer from conjunctivitis.
The scurf and secretion of animal scurf animal carry sensibiligen.Cat, dog allergen dust and furniture decoration indoors
In be widely present.
Fungi allergen mould discharges allergenicity spore into indoor and outdoor environment, and hygrothermal environment growth is rapid.
Cockroach allergens allergen is seen in its excrement and crust, and particle is larger, is not sent out in air.(6)Food becomes
Answer original when allergic rhinitis are not accompanied by other systems symptom, food allergy is rare.On the other hand, in the multiple organs of patient
In the case of involvement, food allergy is common.For baby, majority is caused by milk and soybean;For adult
Common food allergen includes:Peanut, nut, fish, egg, milk soybean, apple, pears etc..
The classical symptom of allergic rhinitis is mainly paroxysmal sneeze, clear water sample nasal mucus, nasal obstruction and rhiocnesmus.Part is with smelling
Feel decline.Sneeze:Paroxysmal is broken out for several times daily, is more than 3 every time, mostly from morning or after night or contact allergy original at once
Breaking-out.Clear nasal discharge:A large amount of clear water sample nasal mucus, can not feel and drip from nostril sometimes.Nasal obstruction:Interval continues, unilateral or bilateral, gently
Weight degree differs.Rhiocnesmus:Most patients are intranasal to itch, and pollinosis patient can itch with eye, ear itching and pharynx are itched.
Allergic Rhinitis is because without effective therapy, uncontrollable sneeze runny nose is very painful.
Doctor trained in Western medicine treats the therapy not being suitble to for allergic rhinitis, can not effect a radical cure.Existing Chinese medicine compound prescription makes more
With containing drugs such as the achenes of Siberian cocklebur, ineffective, some is also toxic.
Invention content
It is an object of the invention to disclose a kind of pharmaceutical composition for treating allergic rhinitis, the present invention also aims to
The preparation method of open the composition.
A kind of pharmaceutical composition for treating allergic rhinitis according to the present invention, it is mainly by radix bupleuri, lepidium seed, osmanthus
Branch, asarum, the root of purple-flowered peucedanum, chlorite schist, pinellia, psoralea corylifolia, Cortex Magnoliae Officinalis, dried orange peel, the dried immature fruit of citron orange, Chinese yam, Poria cocos, the tuber of stemona, mulberries, adenophora tetraphylla,
Black drought, Schisandra chinensis, Semen Cuscutae, Radix Paeoniae Alba, Radix Glycyrrhizae.
The card of the present invention that cure mainly that is formulated is caused by the liver depression dryness of the lung, and monarch drug in a prescription radix bupleuri liver soothing and depression relief, ministerial drug lepidium seed removes
The dryness of the lung;Cassia twig, asarum relieving the exterior syndrome with drugs pungent in flavor and warm in property are evil, and the root of purple-flowered peucedanum, chlorite schist restrain lung qi, and pinellia drop is inverse, and psoralea corylifolia, Cortex Magnoliae Officinalis receive lung qi, dried orange peel,
Dried immature fruit of citron orange qi-regulating, Chinese yam, Poria cocos tonifying spleen benefit stomach adjutant, the tuber of stemona, mulberries, adenophora tetraphylla, eclipta enriching yin clearind deficient heat, Schisandra chinensis, Tu
Silk, Radix Paeoniae Alba tonifying liver kidney yin, altogether to make medicine, all formulas are matched for Radix Glycyrrhizae coordinating the drug actions of a prescription, plays solution liver depression altogether and removes the dryness of the lung, qi-regulating heat-clearing is good for
The effect of spleen facilitaing lung.
Solution liver depression of the present invention removes the dryness of the lung, qi-regulating heat-clearing, and invigorating the spleen facilitaing lung is used for clinical common liver depression dryness of the lung type rhinitis, due to
Liver Channel pent-up, lung heat impairment of yin, nose key, which loses, supports and causes.Symptoms include rhiocnesmus, sneeze runny nose, nasal obstruction, red tongue body, Tai Bai and do, pulse condition is thin
Number.
The pharmaceutical composition of the present invention and its dosage of drug component are also to carry out largely groping to summarize by inventor
Go out
The composition and parts by weight of a kind of described pharmaceutical composition for treating allergic rhinitis for the treatment of be:Radix bupleuri 30-220
Part, 60-200 parts of lepidium seed, 10-160 parts of cassia twig, 10-160 parts of asarum, 50-150 parts of the root of purple-flowered peucedanum, 50-150 parts of chlorite schist, ginger
50-150 parts of the tuber of pinellia, 50-150 parts of psoralea corylifolia, 50-150 parts of Cortex Magnoliae Officinalis, 50-150 parts of dried orange peel, 50-150 parts of the dried immature fruit of citron orange, Chinese yam
50-150 parts, 50-150 parts of Poria cocos, 30-130 parts of the tuber of stemona, 30-130 parts of mulberries, 30-130 parts of adenophora tetraphylla, eclipta
10-90 parts, 5-80 parts of Schisandra chinensis, 3-90 parts of Semen Cuscutae, 5-80 parts of Radix Paeoniae Alba, 5-120 parts of Radix Glycyrrhizae.
A kind of the further of described pharmaceutical composition for treating allergic rhinitis for the treatment of forms and parts by weight are:Radix bupleuri
80-180 parts, 80-180 parts of lepidium seed, 50-130 parts of cassia twig, 50-130 parts of asarum, 60-130 parts of the root of purple-flowered peucedanum, chlorite schist 60-
130 parts, 60-130 parts of pinellia, 60-130 parts of psoralea corylifolia, 60-130 parts of Cortex Magnoliae Officinalis, 60-130 parts of dried orange peel, the dried immature fruit of citron orange 60-130
Part, 60-130 parts of Chinese yam, 60-120 parts of Poria cocos, 50-120 parts of the tuber of stemona, 50-110 parts of mulberries, 50-110 parts of adenophora tetraphylla,
30-80 parts of eclipta, 10-70 parts of Schisandra chinensis, 10-80 parts of Semen Cuscutae, 10-70 parts of Radix Paeoniae Alba, 50-100 parts of Radix Glycyrrhizae.
A kind of the preferred of described pharmaceutical composition for treating allergic rhinitis for the treatment of forms and parts by weight are:Radix bupleuri
180 parts, 160 parts of lepidium seed, 130 parts of cassia twig, 130 parts of asarum, 130 parts of the root of purple-flowered peucedanum, 130 parts of chlorite schist, 130 parts of pinellia, psoralea corylifolia
120 parts, 110 parts of Cortex Magnoliae Officinalis, 120 parts of dried orange peel, 110 parts of the dried immature fruit of citron orange, 100 parts of Chinese yam, 100 parts of Poria cocos, 100 parts of the tuber of stemona, 90 parts of mulberries,
80 parts of adenophora tetraphylla, 80 parts of eclipta, 60 parts of Schisandra chinensis, 50 parts of Semen Cuscutae, 60 parts of Radix Paeoniae Alba, 60 parts of Radix Glycyrrhizae.
A kind of the preferred of described pharmaceutical composition for treating allergic rhinitis for the treatment of forms and parts by weight are:Radix bupleuri
150 parts, 120 parts of lepidium seed, 100 parts of cassia twig, 100 parts of asarum, 90 parts of the root of purple-flowered peucedanum, 70 parts of chlorite schist, 70 parts of pinellia, psoralea corylifolia 70
Part, 80 parts of Cortex Magnoliae Officinalis, 70 parts of dried orange peel, 110 parts of the dried immature fruit of citron orange, 100 parts of Chinese yam, 80 parts of Poria cocos, 80 parts of the tuber of stemona, 80 parts of mulberries, adenophora tetraphylla
80 parts, 70 parts of eclipta, 60 parts of Schisandra chinensis, 50 parts of Semen Cuscutae, 60 parts of Radix Paeoniae Alba, 80 parts of Radix Glycyrrhizae.
A kind of the preferred of described pharmaceutical composition for treating allergic rhinitis for the treatment of forms and parts by weight are:Radix bupleuri
120 parts, 120 parts of lepidium seed, 100 parts of cassia twig, 80 parts of asarum, 70 parts of the root of purple-flowered peucedanum, 80 parts of chlorite schist, 70 parts of pinellia, 80 parts of psoralea corylifolia,
120 parts of Cortex Magnoliae Officinalis, 110 parts of dried orange peel, 80 parts of the dried immature fruit of citron orange, 80 parts of Chinese yam, 80 parts of Poria cocos, 100 parts of the tuber of stemona, 60 parts of mulberries, adenophora tetraphylla 80
Part, 70 parts of eclipta, 60 parts of Schisandra chinensis, 70 parts of Semen Cuscutae, 60 parts of Radix Paeoniae Alba, 50 parts of Radix Glycyrrhizae.
In short, the present invention forms monarch, minister, helps, makes various, compatibility is rigorous, complements each other, and plays solution liver depression altogether and removes the dryness of the lung, reason
Gas heat-clearing, the work(of invigorating the spleen facilitaing lung.
Customary adjuvant can be added in drug of the present invention, according to common process, be made clinically-acceptable tablet, granule,
Pill, capsule, sustained release agent, oral liquid etc..
The preparation method of drug of the present invention includes the following steps:
Chinese yam, more than Poria cocos two tastes are ground into fine powder, are sieved, remaining 19 taste decocting concentrates, dry.Mixing, system
Grain, dry, mixing makes pellet, dry, encapsulated.
The preparation method of the tablet of drug of the present invention includes the following steps:Chinese yam, more than Poria cocos two tastes are ground into fine powder, mistake
Sieve.Remaining 19 taste decocting concentrates, dry.Mixing makes pellet, dry, and tablet is made.
The preparation method of the oral solution of drug of the present invention includes the following steps:Above 20 simply after decocting, concentration, mistake
Filter, is made oral solution.
The preparation method of drug of the present invention preferably includes following steps:Chinese yam, more than Poria cocos three tastes are ground into fine powder, mistake
Sieve, remaining 19 taste decocting 2 times 30 minutes every time, concentrate, spray drying, and mixing makes pellet, dry, and tablet is made.
Specific implementation mode
The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention..
Embodiment 1
1, prescription:
180 parts of radix bupleuri, 160 parts of lepidium seed, 130 parts of cassia twig, 130 parts of asarum, 130 parts of the root of purple-flowered peucedanum, 130 parts of chlorite schist, pinellia
130 parts, 120 parts of psoralea corylifolia, 110 parts of Cortex Magnoliae Officinalis, 120 parts of dried orange peel, 110 parts of the dried immature fruit of citron orange, 100 parts of Chinese yam, 100 parts of Poria cocos, the tuber of stemona 100
Part, 90 parts of mulberries, 80 parts of adenophora tetraphylla, 80 parts of eclipta, 60 parts of Schisandra chinensis, 50 parts of Semen Cuscutae, 60 parts of Radix Paeoniae Alba, 60 parts of Radix Glycyrrhizae.
2. preparation method:
Chinese yam, more than Poria cocos two tastes are ground into fine powder, are sieved.Remaining 19 taste decocting 2 times 30 minutes every time, concentrates, spray
Mist is dried, mixing, is made pellet, dry, and tablet is made, be made 1000 to get.
Embodiment 2
1, prescription:
Radix bupleuri 150g, lepidium seed 120g, cassia twig 100g, asarum 100g, root of purple-flowered peucedanum 90g, chlorite schist 70g, pinellia 70g, Psoralen
Fat 70g, Cortex Magnoliae Officinalis 80g, dried orange peel 70g, dried immature fruit of citron orange 110g, Chinese yam 100g, Poria cocos 80g, tuber of stemona 80g, mulberries 80g, adenophora tetraphylla 80g,
Eclipta 70g, Schisandra chinensis 60g, Semen Cuscutae 50g, Radix Paeoniae Alba 60g, Radix Glycyrrhizae 80g.
2. preparation method:
Above 20 simply after decocting, concentrates, filtering, be made oral solution 1000ml to get.
Embodiment 3
1, prescription:
Radix bupleuri 120g, lepidium seed 120g, cassia twig 100g, asarum 80g, root of purple-flowered peucedanum 70g, chlorite schist 80g, pinellia 70g, psoralea corylifolia
80g, Cortex Magnoliae Officinalis 120g, dried orange peel 110g, dried immature fruit of citron orange 80g, Chinese yam 80g, Poria cocos 80g, tuber of stemona 100g, the sub- 60g of mulberries, adenophora tetraphylla 80g, ink
Non-irrigated lotus 70g, Schisandra chinensis 60g, Semen Cuscutae 70g, Radix Paeoniae Alba 60g, Radix Glycyrrhizae 50g.
2, technique:
Chinese yam, more than Poria cocos two tastes are ground into fine powder, are sieved.Remaining nine taste decocting 2 times 30 minutes every time, concentrates, spraying
Dry, mixing makes pellet, dry, and capsule is made, be made 1000 to get.
Embodiment 4
1, prescription:
Radix bupleuri 150g, lepidium seed 120g, cassia twig 100g, asarum 100g, root of purple-flowered peucedanum 90g, chlorite schist 70g, pinellia 70g, Psoralen
Fat 70g, Cortex Magnoliae Officinalis 80g, dried orange peel 70g, dried immature fruit of citron orange 110g, Chinese yam 100g, Poria cocos 80g, tuber of stemona 80g, mulberries 80g, adenophora tetraphylla 80g,
Eclipta 70g, Schisandra chinensis 60g, Semen Cuscutae 50g, Radix Paeoniae Alba 60g, Radix Glycyrrhizae 80g.
2. preparation method:
Chinese yam, more than Poria cocos three tastes are ground into fine powder, are sieved.Remaining nine taste decocting 2 times 30 minutes every time, concentrates, spraying
Dry, mixing makes pellet, dry, be made capsule 800 to get.
Embodiment 5
1, prescription:
180 parts of radix bupleuri, 160 parts of lepidium seed, 130 parts of cassia twig, 130 parts of asarum, 130 parts of the root of purple-flowered peucedanum, 130 parts of chlorite schist, pinellia
130 parts, 120 parts of psoralea corylifolia, 110 parts of Cortex Magnoliae Officinalis, 120 parts of dried orange peel, 110 parts of the dried immature fruit of citron orange, 100 parts of Chinese yam, 100 parts of Poria cocos, the tuber of stemona 100
Part, 90 parts of mulberries, 80 parts of adenophora tetraphylla, 80 parts of eclipta, 60 parts of Schisandra chinensis, 50 parts of Semen Cuscutae, 60 parts of Radix Paeoniae Alba, 60 parts of Radix Glycyrrhizae.
2. preparation method:
Above 20 simply after decocting, concentrates, filtering, be made oral solution 1000ml to get.
6 test of pesticide effectiveness of embodiment:Nose clearing capsule treats the animal experiment of allergic rhinitis
【Test material】
Test medicine:Nose clearing capsule:Chocolate brown powder, is made by embodiment 3 by 0.3g/, and institute is made into distilled water with preceding
The suspension of the concentration needed.
Chlorpheniramine maleate tablets, the production of Hubei Central China pharmaceutical factory(Lot number 120602).
【Test method and result】
The foundation of model:Every cavy of model group adds equivalent Fo Shi to help completely on the 1st week with ragweed pollen allergen 0.75ml
Agent (volume ratio 1,1), in intraperitoneal injection 0.sml, four limbs subcutaneous (oxter, groin) respectively inject 0.25ml, total 1.5ml, the 3rd, 4
Zhou Gaiwei allergens add Freund incomplete adjunvant, 1 times a week;Normal group replaces allergen with physiological saline.In the 4th weekend
Nasal cavity excitation is carried out, 0.5% ragweed pollen allergen normal saline solution of model group drips people's cavy bilateral nose with sample injector
Hole (per side 1ul), one time a day, continuous 5 days;Normal group replaces allergen collunarium with physiological saline.
Experiment on therapy is grouped:Model group excites 1 time the next day being changed to after exciting the 5th day and is randomly divided into 3 groups, i.e.,:
Model group:Physiological saline gavage is treated;Positive group:Chlorpheniramine, gavage, every 1.2mg are treated once a day;Medication therapy groups:
Nose clearing capsule is oral, 2 times a day, daily 18g crude drug amounts/kg.Former Normal group is separately set as blank control group, in treatment rank
Section physiological saline gavage.Each group treats 20 days, 3 times a day.
Detection project and method:Sniffle sign:In antigen (or physiological saline) collunarium 30 minutes, collunarium is after 2 hours
It observes again 30 minutes.Sniffle standards of grading, rhiocnesmus:1 point, dab nose several times;2 points, scratching nose, face are more than, scouring everywhere.
Sneeze:1 point, 1 one 3;2 points, 4 ~ 10;3 points, 11 or more.Clear nasal discharge:1 point, it flow to anterior naris;2 points, be more than anterior naris;3
Point, runny nose is had one's face covered with.
Nasal secretion smear:After excitation symptom occurs, wipes secretion smear with small swab stick and carry out Wright dyeing.
As a result statistical procedures are carried out with t inspections.
It the results are shown in Table 1.
Influence (x ± s) of the 1 nose clearing capsule of table to sniffle and the sign scoring of allergic rhinitis in guinea-pig(n=10)
Note:Compared with blank control, the scoring P of model group<0.05,
Compared with model group, positive group and nose clearing capsule group p<0.05
As shown in Table 1, nose clearing capsule group can subtract sniffle and the sign scoring of clear allergic rhinitis in guinea-pig, statistics knot
Fruit has notable statistical significance.
2 nose clearing capsule of table checks the nasal discharge eosinophil of allergic rhinitis in guinea-pig the influence (x of average
±s )(n=10)
Note:Compared with blank control, the scoring P of model group<0.05,
Compared with model group, positive group and nose clearing capsule group p<0.05
7 toxicity test of embodiment
【Test material】
Test medicine:Nose clearing capsule:Chocolate brown powder, is made by embodiment 3 by 0.3g/, and institute is made into distilled water with preceding
The concentration needed.
【Test method and result】
18 ± 2g of Kunming mouse used in acute toxicity test, half male and half female.After 3 d of this laboratory adaptation are bought in selection
In good condition, behavior, activity animal without exception are tested。14 ~ 16 h of fasting before each animal administration, fasting 4 after administration
H can't help water.Single oral gavage is administered when experiment, and 40 mL/ kg, wherein blank control group give the distilled water for waiting capacity.After administration
The response situation of animal, and 4 h of continuous observation are observed, 7 d. acute toxicity test observation index are observed continuously:Observe animal body
Quality, diet, appearance, behavior, secretion, excreta and poisoning symptom, the initial time of toxic reaction, continue severity
Time records the death condition of animal, and distinguishes the 3rd day (D3), the 7th day (D7) title animal after (D0), administration before administration
The scale of construction.
It is administered in 4 h and in 1 week, blank control group shows no obvious abnormalities reaction, and all animals have no dead.Each group is dynamic
Object amount normally increases, and administration group is compared with blank group, no significant difference.Illustrate that the pharmaceutical composition is safe and non-toxic
Property.