CN101904885A - Medicinal composition for treating allergic rhinitis and preparation method and application thereof - Google Patents
Medicinal composition for treating allergic rhinitis and preparation method and application thereof Download PDFInfo
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Abstract
The invention provides a medicinal composition for treating allergic rhinitis, which is a medicament prepared from the following traditional Chinese medicines in part by weight: 14 to 26 parts of paniculate swallowwort root, 3.15 to 5.85 parts of cicada slough, 0.021 to 0.039 part of borneol and 0.21 to 0.39 part of bezoar. The invention also provides a preparation method and application of the medicinal composition. The medicinal composition has the effects of expelling wind, reducing heat, and causing resuscitation and refreshing nose and has an obvious clinical treatment effect. Efficacy trials show that drops of the medicinal composition relieves allergic reaction of nasal meatus by reducing AR guinea pig blood LTE4, IgE concentration, inhibiting the release of inflammatory mediator and reducing the aggregation of inflammatory cells on mucous membrane of nose.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of allergic rhinitis.Belong to drug world.
Background technology
(Allergic rhinitis AR), claims allergic rhinitis again to allergic rhinitis, is by discharging the nasal mucosa I allergic reaction type that histamine, kassinin kinin class and leukotriene etc. bring out by IgE (IgE) mediation.Cardinal symptom has rhinocnesmus, sneeze, watery nasal discharge, nasal obstruction etc.In recent years, the people in the whole world 10%～25% is subjected to the puzzlement of allergic rhinitis, and sickness rate once increased trend year by year.Though AR is not a serious disease, can influences patient's daily life such as sleep, study, work, and can bring out bronchial asthma, sinusitis, nasal polyp, otitis media and allergic conjunctivitis etc.Therefore, seeking effective Therapeutic Method and medicine is the common problem of paying close attention in the whole world.
At present the medicine of AR western medicine mainly contains antihistaminic, glucocorticoid hormone, Decongestant, anticholinergic agent and mast cell stabilizers 5 classes, but since these medicines for a long time with easily produce untoward reaction, late result is poor, all can not reach ideal requirement.And the organic conception of the traditional Chinese medical science, determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs and Chinese medicine medicine source is wide, toxic and side effects is little are the advantage places of traditional Chinese medical herbal treatment primary disease.Therefore, use Chinese medical theory treatment AR and become the research focus.As application number: 200510030089.7, denomination of invention: a kind of Chinese medicine for external application for the treatment of allergic rhinitis and preparation method thereof, this disclosure of the Invention a kind of Chinese medicine for external application for the treatment of allergic rhinitis.Said preparation is made up of Radix Angelicae Sinensis, Radix Rubiae, Herba Centipedae, this preparation confirms that through zoopery the aspects such as eosinophil count, histopathology of histamine content, nasal discharge to TDI, egg protein sensitization rat rhinitis model subordinate act, blood and nasal mucosa observe, and the improvement effect is all arranged.Find that through safety experiment this invention preparation all has no stimulation to rabbit intact skin mucosa and damaged mucosa; The acute toxicity testing result shows, is tried rat and do not see toxic reaction at 86 times of following collunariums of human dosage.Preparation is to start with blood stasis dispelling, and gentle to nourish blood, declare clearing the nasal passage be the rule of treatment, and strengthening vital QI to eliminate pathogenic factors and usefulness have the excellent development application prospect.
Treatment by Chinese herbs AR is many based on oral formulations at present, and is comparatively rare to the report of nasal cavity local application.Nasal cavity has abundant mucosa, and serial fine hair and epithelial cell are arranged on the mucosa, and fine hair increases the nasal mucosa absorption area, and a large amount of capillary network under the mucosa can be absorbed medicine very soon.The nasal-cavity administration onset is rapid than oral medication, and the untoward reaction that can avoid whole body use to produce, and no first pass effect, medicine can reach efficiently, safe, therapeutic effect easily.
Summary of the invention
Technical scheme of the present invention has provided a kind of pharmaceutical composition for the treatment of allergic rhinitis.Another technical scheme of the present invention has provided this preparation of drug combination method and purposes.
The invention provides a kind of pharmaceutical composition for the treatment of allergic rhinitis, it is the preparation that is prepared from by following weight Chinese medicinal raw materials medicine:
Radix Cynanchi Paniculati 14-26 part, Periostracum Cicadae 3.15-5.85 part, Borneolum Syntheticum 0.021-0.039 part, Calculus Bovis 0.21-0.39 part.
Further preferably, it is the preparation that is prepared from by following weight Chinese medicinal raw materials medicine:
20 parts of Radix Cynanchi Paniculatis, 4.5 parts of Periostracum Cicadaes, 0.03 part of Borneolum Syntheticum, 0.3 part of Calculus Bovis.
Medicine of the present invention is to be active component by water of Radix Cynanchi Paniculati, Periostracum Cicadae or extractive with organic solvent, adds Borneolum Syntheticum, Calculus Bovis, and acceptable accessories or complementary composition preparation preparation pharmaceutically commonly used.
Wherein, described preparation is a nasal drop.
Further, described nasal drop is drop, spray, injectant or detergent.
Wherein, described drop is a gel drop, and it is to be prepared from by following raw materials by weight proportions and adjuvant:
Radix Cynanchi Paniculati 14-26 part, Periostracum Cicadae 3.15-5.85 part, Borneolum Syntheticum 0.021-0.039 part, Calculus Bovis 0.21-0.39 part, potassium sorbate 0.14-0.26 part, Rhizoma Bletillae gel 0.7-1.3 part, Acritamer 940 0.63-1.17 part, glycerol 7-13 part, triethanolamine 1.26-2.34 part.
Further preferably, described gel drop is to be prepared from by following raw materials by weight proportions and adjuvant:
20 parts of Radix Cynanchi Paniculatis, 4.5 parts of Periostracum Cicadaes, 0.03 part of Borneolum Syntheticum, 0.3 part of Calculus Bovis, 0.2 part of potassium sorbate, 1 part of Rhizoma Bletillae gel, 0.9 part of Acritamer 940,10 parts of glycerol, 1.8 parts of triethanolamine.
Wherein, the weight percent that contains paeonol in the described gel drop is not less than 0.2284%, and the weight percentage that contains Borneolum Syntheticum is not less than 0.02759%.
The present invention also provides the method for preparing this pharmaceutical composition, and described gel drop preparation method comprises the steps:
A, take by weighing materials of weight proportions and adjuvant:
B, get the Radix Cynanchi Paniculati decoction pieces, adopt steam distillation, collect distillate, cold preservation crystallization or add sodium chloride cold preservation crystallization, distillate volume and sodium chloride mass ratio are 100: 2.5～10, filtration, vacuum drying promptly gets the paeonol crystallization; Adopt the beta-cyclodextrin inclusion compound method, get the paeonol cyclodextrin clathrate, drying for standby;
C, the Radix Cynanchi Paniculati of b step is collected residue after the distillate, add Periostracum Cicadae, decoct with water, filter, filtrate concentrates, clarification, supernatant, concentrate, concentrated solution;
D, get Borneolum Syntheticum, adopt beta-cyclodextrin inclusion compound method enclose, the Borneolum Syntheticum cyclodextrin clathrate;
E, get the concentrated solution of c step, add Acritamer 940, Rhizoma Bletillae gel, stir swelling, add glycerol and potassium sorbate, stir, regulate pH6.0, gel-type vehicle, standby;
F, get b step paeonol cyclodextrin clathrate, d step Borneolum Syntheticum cyclodextrin clathrate, Calculus Bovis, behind the mix homogeneously, add in the described gel-type vehicle of e step, stir, make gel.
Wherein, agent 101 fruit juice clarifiers are adopted in the described clarification of c step.
The present invention also provides the purposes of described pharmaceutical composition in the pharmaceutical composition of preparation treatment allergic rhinitis.
Wherein, described medicine is the medicine of nasal mucosa topical.
The removing dampness of dispeling the wind of Radix Cynanchi Paniculati property and flavor of peppery and warm in the medicine material of the present invention, function, antalgesic-antipruritic is to be monarch drug; Periostracum Cicadae is sweet in flavor and cold in property, the function wind heat extraction that looses, and the sore-throat relieving rash helps the merit of Radix Cynanchi Paniculati antalgesic-antipruritic and removes its too hot dry fraud, so be ministerial drug; The sweet cold of Calculus Bovis nature and flavor, the function waking up the patient from unconsciousness by dissipating phlegm, heat-clearing and toxic substances removing plays the effect that assistant helps, so be adjuvant drug; The natural Broneolum Syntheticum nature and flavor are arduous to be slightly cold, the function refreshment of having one's ideas straightened out, and clearing away heat to alleviate pain, and can priming up, so be messenger drug.Make a general survey of full side, treating both the principal and secondary aspects of a disease, all medicines share, the effect of long memorial wind heat clearing away altogether, the awake nose of having one's ideas straightened out.
Medicine of the present invention has wind and heat dispersing, the effect of awake nose of having one's ideas straightened out, and clinical efficacy is remarkable, and being prepared into gel is homogeneous latex glop, can long period and site of action tight adhesion, drug treating time prolongs, and better biocompatibility is arranged, and uses comfortable; Medicine is directly thrown on the nasal mucosa, can be dropped to minimum to general action, medicine focuses on nose and produces optimum curative effect.The above-mentioned test of pesticide effectiveness shows that drug gel drop of the present invention is by reducing AR guinea pig blood LTE
4, IgE concentration, suppress the release of inflammatory mediator, reduce the gathering of inflammatory cell, thereby alleviate the allergy of nasal meatus at nasal mucosa.
Obviously, according to foregoing of the present invention,,, can also make modification, replacement or the change of other various ways not breaking away under the above-mentioned basic fundamental thought of the present invention prerequisite according to the ordinary skill knowledge and the customary means of this area.
The specific embodiment of form is described in further detail foregoing of the present invention again by the following examples.But this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to following example.All technology that realizes based on foregoing of the present invention all belong to scope of the present invention.
Description of drawings
Fig. 1: normal group Cavia porcellus nasal mucosa is organized oxyphil cell's light microscopic picture (HE * 400)
Fig. 2: model group Cavia porcellus nasal mucosa is organized oxyphil cell's light microscopic picture (HE * 400)
Fig. 3: drug gel drop I group Cavia porcellus nasal mucosa of the present invention is organized oxyphil cell's light microscopic picture (HE * 400)
Fig. 4: drug gel drop II group Cavia porcellus nasal mucosa of the present invention is organized oxyphil cell's light microscopic picture (HE * 400)
Fig. 5: Rhinocort group Cavia porcellus nasal mucosa is organized oxyphil cell's light microscopic picture (HE * 400)
The specific embodiment
The preparation of embodiment 1 drug gel drop of the present invention
A, take by weighing following materials of weight proportions:
Radix Cynanchi Paniculati 20g, Periostracum Cicadae 4.5g, natural Broneolum Syntheticum 0.03g, artificial Calculus Bovis 0.3g
B, get Radix Cynanchi Paniculati, add water, soaked 30 minutes, the employing steam distillation by 20 times of amounts of crude drug weight, extracted 3 hours, and collected distillate, add sodium chloride cold preservation crystallization, distillate volume and sodium chloride mass ratio are 100: 5, filter, vacuum drying promptly gets the paeonol crystallization; Get the paeonol crystallization, add an amount of ethanol and make its dissolving, slowly add in the beta-schardinger dextrin-saturated aqueous solution, paeonol crystallization and The quality of ss-cyclodextrin ratio are 1: 8, under 45 ℃ again, 800r/min stirred enclose after 1 hour, cold preservation 24 hours filters vacuum drying, get the paeonol cyclodextrin clathrate, standby;
C, the Radix Cynanchi Paniculati of b step is collected residue after the distillate, add Periostracum Cicadae, add water, decoct 2 times, wherein for the first time add water, decocted 1 hour, add 8 times in water for the second time, decocted 40 minutes by 10 times of crude drug weight, filter, merging filtrate is concentrated into 100ml with filtrate, adds 5%101 fruit juice clarifiers, its medicinal liquid and clarifier volume ratio are 100: 18, stir, and leave standstill a few hours, the 5%101 juice clarification agent aids that add equivalent again stir, and are centrifugal, get supernatant, be concentrated into 80ml, get concentrated solution;
D, get natural Broneolum Syntheticum, add an amount of ethanol and make its dissolving, slowly add in the beta-schardinger dextrin-saturated aqueous solution, Borneolum Syntheticum and The quality of ss-cyclodextrin ratio are 1: 6, under 30 ℃, 800r/min stirred enclose after 1.5 hours, cold preservation 24 hours filters vacuum drying, get the natural Broneolum Syntheticum cyclodextrin clathrate, standby;
E, get the concentrated solution of c step, add 0.9g Acritamer 940,1g Rhizoma Bletillae gel, stir swelling, add 10g glycerol and 0.2g potassium sorbate, stir, add the 1.8g triethanolamine again and regulate pH to 6.0-6.5, gel-type vehicle, standby;
F, get b step paeonol cyclodextrin clathrate 2.2g, d step Borneolum Syntheticum cyclodextrin clathrate 0.25g, Calculus Bovis 0.3g, behind the mix homogeneously, add in the described gel-type vehicle of e step, stir, make gel drop.
With the gel drop packing that makes, every 10g, the paeonol weight percent is not less than 0.2284% in the gel, and the weight percent of Borneolum Syntheticum is not less than 0.02759%.
The preparation of embodiment 2 drug gel drops of the present invention
1. the paeonol extraction process in the Radix Cynanchi Paniculati
Recipe quantity Radix Cynanchi Paniculati and Periostracum Cicadae are added 20 times of water, soak 0.5h, decoct 3h after, collect distillate, add 5% (g/ml) sodium chloride, cold preservation 24h filters, crystallization is with distilled water wash number time, evacuation drying under the room temperature.
2. paeonol clathrate process
Get paeonol 2g and be dissolved in the 12ml ethanol, slowly splash in the 400ml beta-schardinger dextrin-saturated aqueous solution, 45 ℃ of water temperatures, mixing time 1h (800r/min), cold preservation 24h filters.Ethyl acetate is washed 3 times on a small quantity, dries up.Room temperature evacuation drying.
3. Borneolum Syntheticum clathrate process
Borneolum Syntheticum 1g is dissolved among the 10ml, slowly splashes in the 280ml beta-schardinger dextrin-saturated aqueous solution, and 30 ℃ of water temperatures, mixing time 1.5h (800r/min), cold preservation 24h filters.Ethyl acetate is washed 3 times on a small quantity, dries up.Room temperature evacuation drying.
4. gel preparation technology
Radix Cynanchi Paniculati is collected residue after the distillate, add Periostracum Cicadae, add water, decoct 2 times, wherein for the first time add water, decocted 1 hour, add 8 times in water for the second time by 10 times of crude drug weight, decocted 40 minutes, filter, merging filtrate, filtrate is concentrated into the centrifugal 10min of 100ml medicinal liquid after (3500r./min) add the 18ml5%101 clarifier, after leaving standstill a few hours, the centrifugal supernatant that gets is concentrated into 80ml, adds 0.2g potassium sorbate and 1g Rhizoma Bletillae powder, 0.9gCb940,10g glycerol, swelling stirs, add the 1.8g triethanolamine again, stir evenly.With 2.2g paeonol clathrate and 0.25g Borneolum Syntheticum clathrate, the 0.3g Calculus Bovis, the chromatography mixing adds, and stirs evenly packing.
Every 10g, the paeonol weight percent is not less than 0.2284% in the gel drop, and the weight percent of Borneolum Syntheticum is not less than 0.02759%.
The preparation of embodiment 3 medicament spraying agents of the present invention
Get Radix Cynanchi Paniculati 14g, Periostracum Cicadae 5.85g, Borneolum Syntheticum 0.039g, Calculus Bovis 0.39g, press embodiment 1 described method and extract medical material, concentrated solution adds conventional adjuvant, and the spray bottle of packing into is prepared into spray.
The preparation of embodiment 4 medicine injectants of the present invention
Radix Cynanchi Paniculati 26g, Periostracum Cicadae 3.15g, Borneolum Syntheticum 0.021g, Calculus Bovis 0.21g press embodiment 2 described methods and extract medical material, and concentrated solution adds conventional adjuvant, and embedding is prepared into injectant.
The preparation of embodiment 5 medicine detergents of the present invention
Radix Cynanchi Paniculati 26g, Periostracum Cicadae 3.15g, Borneolum Syntheticum 0.021g, Calculus Bovis 0.21g press embodiment 1 described method and extract medical material, and concentrated solution adds conventional adjuvant, is prepared into detergent.
Embodiment 6 medicament gelling agent content assaying methods of the present invention
1) assay of paeonol in the gel
(1) chromatographic condition and system suitability test: chromatographic column: Hypersil ODS (250mm * 4.6mm, 5 μ m); Mobile phase: nitrile-0.1% phosphoric acid solution (60: 40); Flow velocity 1.0ml/min; 30 ℃ of column temperatures; Detect wavelength 274nm.Theoretical cam curve should be not less than 3000 by the paeonol peak area.
(2) preparation of reference substance solution: precision takes by weighing paeonol reference substance 10.06mg, puts in the 25ml measuring bottle, adds anhydrous alcohol solution and to scale, shakes up, in contrast the product storing solution.Precision pipettes 1ml reference substance storing solution to the 10ml measuring bottle again, adds dehydrated alcohol and is diluted to scale, shakes up, promptly.
(3) preparation of need testing solution: precision takes by weighing sample 0.25g, puts in the 15ml tool plug centrifuge tube, the accurate 10ml dehydrated alcohol that adds, and (250W 40kHz), filters ultrasonic 40min, gets subsequent filtrate, promptly.
(4) algoscopy and measurement result
Accurate respectively reference substance solution and each 5ul of need testing solution of drawing injects chromatograph of liquid, measures, promptly.
Table sample determination result
The weight percent that records paeonol must not be lower than 0.2284%.
2) assay of Borneolum Syntheticum
(1) chromatographic condition and system suitability test: column temperature: 150 ℃; Vaporizer temperature: 230 ℃; Detector: FID; Temperature: 230 ℃; Nitrogen pressure: 4.0 * 10
5Pa; Hydrogen Vapor Pressure: 4.0 * 10
5Pa; Air pressure: 4.0 * 10
5Pa; Flow velocity: 1ml/min; Be not less than 1900 by dextro Borneolum Syntheticum peak theoretical cam curve.
(2) preparation of reference substance solution: precision takes by weighing dextro Borneolum Syntheticum reference substance 24.10mg, puts in the 25ml volumetric flask, adds acetic acid ethyl dissolution and standardize solution, shakes up, and gets reference substance solution.
Precision takes by weighing biphenyl reference substance 15.66mg, puts in the volumetric flask of 50ml, adds acetic acid ethyl dissolution and standardize solution, shakes up, and gets internal standard substance solution.
(3) preparation of need testing solution: precision takes by weighing the 2.0g sample, puts in the 15ml tool plug centrifuge tube, and the accurate 5ml ethyl acetate that adds after 40min is extracted in jolting, filters, and gets subsequent filtrate 4ml and puts in the 5ml measuring bottle, and the accurate 1ml biphenyl inner mark solution that adds shakes up promptly.
(4) algoscopy and measurement result
Accurate respectively reference substance solution and each 2 microlitre of need testing solution drawn, inject gas chromatograph is measured, promptly.
Table sample size measurement result
The weight percent that records Borneolum Syntheticum must not be lower than 0.02759%.
The adjuvant of embodiment 7 drug gel drops of the present invention is selected test
1) Acritamer 940 usage ratio investigation method and result
Get Radix Cynanchi Paniculati 20g, Periostracum Cicadae 4.5g, natural Broneolum Syntheticum 0.03g, artificial Calculus Bovis 0.3g; extract medical material according to embodiment 1 described method; get the 100ml concentrated solution of c step gained; the Acritamer 940 that adds 0.1g, 0.2g, 0.3g, 0.4g, 0.5g, 0.6g, 0.7g, 0.8g, 0.9g, 1g; the stirring swelling is spent the night; add 1g glycerol and 0.2g potassium sorbate; adding triethanolamine again, to be neutralized to PH be 6.0-6.5; the cyclodextrin that adds 2.45g; stir evenly; centrifugal (2500r/min) 30min, observation has or not the cyclodextrin precipitation.
In the above-mentioned test, add the no cyclodextrin deposited phenomenon in the centrifugal back of the gel-type vehicle of 0.9g, 1g Acritamer 940 in the 100ml concentrated solution, but the gel-type vehicle that contains 1g Acritamer 940 thickness too; The cyclodextrin deposited phenomenon is all arranged after the gel-type vehicle of other content Acritamer 940s is centrifugal.
The result shows that the volume ratio of Acritamer 940 adding quality and concentrated solution was advisable with 0.9: 100 in the gel-type vehicle.
2) Rhizoma Bletillae gel usage ratio investigation method and result
Get Radix Cynanchi Paniculati 20g, Periostracum Cicadae 4.5g, natural Broneolum Syntheticum 0.03g, artificial Calculus Bovis 0.3g; extract medical material according to embodiment 1 described method, get the 100ml concentrated solution of c step gained, add the Acritamer 940 of 0.9g; the Rhizoma Bletillae gel that adds 1g, 2g, 3g, 4g, 5g; the stirring swelling is spent the night, and adds 1g glycerol and 0.2g potassium sorbate, and adding triethanolamine again, to be neutralized to pH be 6.0-6.5; the cyclodextrin that adds 2.45g; stir evenly, centrifugal (2500r/min) 30min, observation has or not the cyclodextrin precipitation.
In the above-mentioned test, the gel-type vehicle that adds the 1g Rhizoma Bletillae gel in the 100ml concentrated solution does not have the cyclodextrin precipitation, and the gel-type vehicle of other content Rhizoma Bletillae gel all has the cyclodextrin precipitation.
The result shows that the volume ratio of Rhizoma Bletillae gel adding quality and concentrated solution was advisable with 1: 100 in the gel-type vehicle.
Below prove beneficial effect of the present invention by concrete pharmacodynamics test.
The pharmacodynamics test of experimental example 1 drug gel treatment allergic rhinitis of the present invention
1) animal modeling, grouping and administration
Adopt 0.5mgOVA (ovalbumin) to make antigen, aluminium-hydroxide powder 30mg makes adjuvant, add normal saline 1ml and form suspension, lumbar injection, the next day 1 time, inject sensitization altogether 7 times.After sensitization is finished the 4th day, Cavia porcellus was got a low level, and every side nasal cavity drips with 2%OVA solution 50 μ l and excites, the next day 1 time, totally 5 times, excite to behind the same day the 1st intranasal administration 1h at every turn.
65 of regular grade Hartley Cavia porcelluss, male and female half and half, body weight 350-400g is divided into 5 groups at random, wherein, 10 of gel drop I groups, 10 of gel drop II groups, 10 of western medicine group, 10 of model group, 13 of normal control groups.Beginning administration in the 2nd day behind the 7th sensitizing injection, every day 3 times.Gel drop I group 0.2483g/ml (by embodiment 1 preparation), gel drop II group 0.4966g/ml (by embodiment 1 preparation), western medicine group Rhinocort 1.28g/ml (budesonide nasal spray, purchase pharmaceutical Co. Ltd) in A Silikang, all splash into the bilateral nostril with micro sample adding appliance, every side splashes into 50 μ l at every turn.The normal saline collunarium of capacity such as model group and normal control group usefulness.Successive administration 11 days.
2) observation index and test item
Behavioristics's index is marked after each ovalbumin bilateral nasal cavity collunarium excites, and Cavia porcellus sneeze in the observed and recorded 30min, scratches nose number of times, watery nasal discharge amount, adopts the addition method to calculate total points, total points 〉=5 minute expression modeling success.
(1) sneeze: one-time continuous 3-9 is 1 minute, and 10-14 is 2 minutes, and 〉=15 is 3 minutes.
(2) rhinocnesmus: scratching nose is for 2-3 time 1 minute, and 3-5 time is 2 minutes, and 〉=5 times is 3 minutes.
(3) watery nasal discharge: flowing to the nostril is 1 minute, and surpassing prenaris is 2 minutes, and it is 3 minutes that watery nasal discharge is had one's face covered with.
The blood testing index after treatment in the 11st day finishes, overnight fasting, the collecting blood sample that breaks end next day is measured by the requirement of test kit description.
(1) serum leukotriene E4 (LTE4) measures and gets serum specimen, detects on the microplate reader of wavelength 450nm with the ELISA method.OD value result according to the standard substance determination of serum of LTE4 test kit built-in draws standard curve, by measuring the OD value of each guinea pig serum LTE4, calculates the serum LTE4 antibody concentration of each Cavia porcellus again.
(2) serum immune globulin E (IgE) assay method is the same, detects on the microplate reader of wavelength 450nm with the ELISA method.SERUM IgE antibody concentration computational methods are the same.
After the morphology of nasal mucosa histopathology and immunohistochemical observation Cavia porcellus broken end is gathered blood and is put to death, get its concha nasalis and in fixing in 10% formalin every mucosa, paraffin embedding, every specimen are cut two, do om observation and SABC inspection respectively.5 (10 * 40) visuals field of every sections observation under the light microscopic, meter oxyphil cell average.Two step method is adopted in the inspection of NF-kB SABC, and concrete operations are undertaken by the test kit description.
3) experimental result
Change table 1 result of behavioristics's index shows, the model group animal sneeze just occurs, scratches the symptom of nose and watery nasal discharge after exciting for OVA solution collunarium the 1st time, along with the increase that excites number of times, symptom is aggravated gradually, when the 4th excites, typical allergic rhinitis symptom occurred.And the gel drop of low, a Senior Two dosage to the sneeze of Cavia porcellus, scratch allergic rhinitis behavioristics symptoms such as nose, watery nasal discharge the obvious suppression effect all arranged, improve the AR symptom.
Table 1 gel drop of the present invention is to the influence of AR Cavia porcellus behavioristics index
Relatively with the F check, adopt SPSS 13.0 statistical package analyses (carrying out the One-Way ANOVA process operation of Compare Means) between above-mentioned The data group.The A group compares with the B group, 1. P＜0.01; C, D, E group compare with the B group, 2. P＜0.01; Relatively there is not significant difference in twos, P＞0.05 between treatment group C, D, E group.
Serum LTE
4, the IgE index change list 2 results show LTE in the model group serum
4, IgE content significantly raises.Compare serum LTE behind the treatment group therapeutic intervention with model group
4, IgE content is lower than model group, gel drop high dose group curative effect is better than low dose group.
Table 2 gel drop of the present invention is to IgE, LTE in the AR guinea pig serum
4The influence of content
Relatively with the F check, adopt SPSS 13.0 statistical package analyses (carrying out the One-Way ANOVA process operation of Compare Means) between above-mentioned The data group.The A group compares P＜0.01 with the B group; C, D, E group compare P＜0.01 with the B group respectively.C, D, E organize the Independent-Sample T Test process operation that adopts Compare Means between two groups: the C group compares P＜0.01 with the D group; The C group compares P＜0.01 with the E group; The D group compares P＜0.05 with the E group.
Change table 3 result of nasal mucosa pathomorphology shows that model group Cavia porcellus nasal mucosa count for eosinophil significantly raises, and treatment group Cavia porcellus count for eosinophil significantly reduces.Each is organized the Cavia porcellus nasal mucosa and organizes oxyphil cell's light microscopic picture to see accompanying drawing 1-5.
Table 3 drug gel drop of the present invention is to the influence of AR Cavia porcellus nasal mucosa count for eosinophil
Relatively with the F check, adopt SPSS 13.0 statistical package analyses (carrying out the One-Way ANOVA process operation of Compare Means) between above-mentioned The data group.The A group compares with the B group, 1. P＜0.01; C, D, E group compare with the B group, 2. P＜0.01; Relatively there are not significant difference, P＞0.05 between each treatment group in twos.
Change table 4 result of SABC shows that the Cavia porcellus NF-kB SABC of A, B, C, D, each group of E does not have significant difference.
The influence of table 4 pair AR Cavia porcellus NF-kB SABC
Medicine of the present invention has wind and heat dispersing, the effect of awake nose of having one's ideas straightened out, and clinical efficacy is remarkable, and being prepared into gel is homogeneous latex glop, can long period and site of action tight adhesion, drug treating time prolongs, and better biocompatibility is arranged, and uses comfortable; Medicine is directly thrown on the nasal mucosa, can be dropped to minimum to general action, medicine focuses on nose and produces optimum curative effect.The above-mentioned test of pesticide effectiveness shows that drug gel drop of the present invention is by reducing AR guinea pig blood LTE
4, IgE concentration, suppress the release of inflammatory mediator, reduce the gathering of inflammatory cell, thereby alleviate the allergy of nasal meatus at nasal mucosa.
Claims (10)
1. pharmaceutical composition for the treatment of allergic rhinitis, it is characterized in that: it is the preparation that is prepared from by following weight Chinese medicinal raw materials medicine:
Radix Cynanchi Paniculati 14-26 part, Periostracum Cicadae 3.15-5.85 part, Borneolum Syntheticum 0.021-0.039 part, Calculus Bovis 0.21-0.39 part.
2. the pharmaceutical composition of treatment allergic rhinitis according to claim 1 is characterized in that: it is the preparation that is prepared from by following weight Chinese medicinal raw materials medicine:
20 parts of Radix Cynanchi Paniculatis, 4.5 parts of Periostracum Cicadaes, 0.03 part of Borneolum Syntheticum, 0.3 part of Calculus Bovis.
3. the pharmaceutical composition of treatment allergic rhinitis according to claim 1 and 2 is characterized in that: described preparation is a nasal drop.
4. the pharmaceutical composition of treatment allergic rhinitis according to claim 3 is characterized in that: described nasal drop is drop, spray, injectant or detergent.
5. the pharmaceutical composition of treatment allergic rhinitis according to claim 4 is characterized in that: described drop is a gel drop, and it is to be prepared from by following raw materials by weight proportions and adjuvant:
Radix Cynanchi Paniculati 14-26 part, Periostracum Cicadae 3.15-5.85 part, Borneolum Syntheticum 0.021-0.039 part, Calculus Bovis 0.21-0.39 part, potassium sorbate 0.14-0.26 part, Rhizoma Bletillae gel 0.7-1.3 part, Acritamer 940 0.63-1.17 part, glycerol 7-13 part, triethanolamine 1.26-2.34 part.
6. the pharmaceutical composition of treatment allergic rhinitis according to claim 5 is characterized in that: described gel drop is to be prepared from by following raw materials by weight proportions and adjuvant:
20 parts of Radix Cynanchi Paniculatis, 4.5 parts of Periostracum Cicadaes, 0.03 part of Borneolum Syntheticum, 0.3 part of Calculus Bovis, 0.2 part of potassium sorbate, 1 part of Rhizoma Bletillae gel, 0.9 part of Acritamer 940,10 parts of glycerol, 1.8 parts of triethanolamine.
7. according to the pharmaceutical composition of claim 5 or 6 described treatment allergic rhinitis, it is characterized in that: the weight percentage that contains paeonol in the described gel drop is not less than 0.2284%, and the weight percentage that contains Borneolum Syntheticum is not less than 0.02759%.
8. method for preparing the pharmaceutical composition of any described treatment allergic rhinitis of claim 5-7, it is characterized in that: described gel drop preparation method comprises the steps:
A, take by weighing materials of weight proportions and adjuvant;
B, Radix Cynanchi Paniculati extract paeonol, cyclodextrin inclusion compound, drying for standby;
C, the residue that the Radix Cynanchi Paniculati of b step is extracted behind the paeonol mix with Periostracum Cicadae, decoct with water, and filter, and filtrate concentrates, clarification, supernatant, concentrated, get concentrated solution;
D, get Borneolum Syntheticum, adopt beta-cyclodextrin inclusion compound method enclose, the Borneolum Syntheticum cyclodextrin clathrate;
E, get the concentrated solution of c step, add Acritamer 940, Rhizoma Bletillae gel, stir swelling, add glycerol and potassium sorbate, stir, regulate pH6.0-6.5, gel-type vehicle, standby;
F, get b step paeonol cyclodextrin clathrate, d step Borneolum Syntheticum cyclodextrin clathrate, Calculus Bovis, behind the mix homogeneously, add in the described gel-type vehicle of e step, stir, make gel.
9. the purposes of any described pharmaceutical composition of claim 1-7 in the pharmaceutical composition of preparation treatment allergic rhinitis.
10. purposes according to claim 9 is characterized in that: described medicine is the medicine of nasal mucosa topical.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105168351A (en) * | 2014-09-12 | 2015-12-23 | 成都中医药大学附属医院 | Application of pharmaceutical composition in preparation of medicines for treating allergic disease |
| CN111135141A (en) * | 2020-01-20 | 2020-05-12 | 蓝佳堂生物医药（福建）有限公司 | Preparation method of composite hydrogel for nasal cavity |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101485721A (en) * | 2009-02-12 | 2009-07-22 | 黄真 | Chinese medicinal composition for resisting allergic rhinitis |
| CN101698000A (en) * | 2009-10-23 | 2010-04-28 | 张晓波 | Traditional Chinese medicine for treating allergic rhinitis |
| CN101700280A (en) * | 2009-11-11 | 2010-05-05 | 丁常燕 | Traditional Chinese medicine for treating allergic rhinitis |
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| CN101485721A (en) * | 2009-02-12 | 2009-07-22 | 黄真 | Chinese medicinal composition for resisting allergic rhinitis |
| CN101698000A (en) * | 2009-10-23 | 2010-04-28 | 张晓波 | Traditional Chinese medicine for treating allergic rhinitis |
| CN101700280A (en) * | 2009-11-11 | 2010-05-05 | 丁常燕 | Traditional Chinese medicine for treating allergic rhinitis |
Non-Patent Citations (1)
| Title |
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| 《山东医药》 20091231 黄丹莉等 中西医结合疗法治疗过敏性鼻炎50例疗效观察 第97页 1－10 第49卷, 第31期 2 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105168351A (en) * | 2014-09-12 | 2015-12-23 | 成都中医药大学附属医院 | Application of pharmaceutical composition in preparation of medicines for treating allergic disease |
| CN111135141A (en) * | 2020-01-20 | 2020-05-12 | 蓝佳堂生物医药（福建）有限公司 | Preparation method of composite hydrogel for nasal cavity |
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Inventor after: Zheng Jian Inventor after: Chu Kedan Inventor after: Xu Wei Inventor after: Huang Xiaobin Inventor after: Lin Xiong Inventor after: Ai Si Inventor after: Li Huang Inventor after: Yan Guohong Inventor after: Pan Xudong Inventor before: Zheng Jian Inventor before: Chu Kedan Inventor before: Xu Wei Inventor before: Lin Xiong Inventor before: Ai Si Inventor before: Li Huang Inventor before: Yan Guohong Inventor before: Pan Xudong |
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