CN107137465A - A kind of pharmaceutical composition of effect of being relievingd asthma with cough-relieving apophlegmatic and preparation method thereof - Google Patents

A kind of pharmaceutical composition of effect of being relievingd asthma with cough-relieving apophlegmatic and preparation method thereof Download PDF

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Publication number
CN107137465A
CN107137465A CN201710385591.2A CN201710385591A CN107137465A CN 107137465 A CN107137465 A CN 107137465A CN 201710385591 A CN201710385591 A CN 201710385591A CN 107137465 A CN107137465 A CN 107137465A
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extract
polygala
pharmaceutical composition
cough
obtains
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徐金城
张军龙
吕卓
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NINGXIA GOLD SUN PHARMACEUTICAL CO Ltd
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NINGXIA GOLD SUN PHARMACEUTICAL CO Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/69—Polygalaceae (Milkwort family)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/34—Campanulaceae (Bellflower family)
    • A61K36/346—Platycodon
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30—Extraction of the material
    • A61K2236/37—Extraction at elevated pressure or temperature, e.g. pressurized solvent extraction [PSE], supercritical carbon dioxide extraction or subcritical water extraction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50—Methods involving additional extraction steps
    • A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

Abstract

The invention discloses a kind of pharmaceutical composition of effect of being relievingd asthma with cough-relieving apophlegmatic and preparation method thereof, the pharmaceutical composition is made up of Radix Platycodonis extract, milkwort extract and ephedrine hydrochloride, wherein Radix Platycodonis extract is 15 100 parts by weight, milkwort extract is 10 75 parts by weight, and ephedrine hydrochloride is 1 18 parts by weight.Pharmaceutical composition of the present invention has effects that cough-relieving apophlegmatic is relievingd asthma, and therapeutic effect is good, persistent；Have no toxic side effect；Simple production process, balloonflower root, polygala are conventional Chinese medicine, and dose is low, and production cost is low.

Description

A kind of pharmaceutical composition of effect of being relievingd asthma with cough-relieving apophlegmatic and preparation method thereof
Technical field
The present invention relates to pharmaceutical field, more particularly, to a kind of pharmaceutical composition of effect of being relievingd asthma with cough-relieving apophlegmatic And preparation method thereof.
Background technology
Respiratory disease be endanger our people health common disease and frequently-occurring disease, such as the infection of the upper respiratory tract, tracheitis, Bronchial astehma, chronic bronchitis, chronic obstructive pneumonia, Influenza A H1N1 etc..In recent years, due to the aging of society And the aggravation of environmental pollution, the incidence of disease of respiratory disease also constantly rising.Cough, breathe heavily, phlegm is respiratory disease Main clinical symptoms, both can individually occur, and can also exist simultaneously, and can influence each other.
Therefore provide a kind of while having the relieving asthma pharmaceutical composition of effect of cough-relieving apophlegmatic to be very necessary.
The content of the invention
It is an object of the invention to provide a kind of while having cough-relieving apophlegmatic to relieving asthma the pharmaceutical composition of effect.
Have simultaneously it is a further object of the present invention to provide this cough-relieving apophlegmatic relieving asthma effect pharmaceutical composition preparation side Method.
The purpose of the present invention is achieved in the following ways：
A kind of pharmaceutical composition of effect of being relievingd asthma with cough-relieving apophlegmatic, it is characterised in that the pharmaceutical composition is carried by balloonflower root Thing, milkwort extract and ephedrine hydrochloride composition are taken, wherein Radix Platycodonis extract is 15-100 parts by weight, and milkwort extract is 10- 75 parts by weight, ephedrine hydrochloride is 1-18 parts by weight.
The pharmaceutical composition of above-mentioned effect of being relievingd asthma with cough-relieving apophlegmatic, preferably said composition Radix Platycodonis extract are 20-80 weights Part is measured, milkwort extract is 10-70 parts by weight, and ephedrine hydrochloride is 1-15 parts by weight.
The pharmaceutical composition of above-mentioned effect of being relievingd asthma with cough-relieving apophlegmatic, more excellent said composition Radix Platycodonis extract is 30 weight Part, milkwort extract is 20 parts by weight, and ephedrine hydrochloride is 3 parts by weight.
Described Radix Platycodonis extract, which is prepared by the following method, to be obtained：Balloonflower root is through CO2Supercritical extract obtains balloonflower root Extract and the balloonflower root dregs of a decoction, by balloonflower root extract beta-cyclodextrin inclusion compound, obtain inclusion compound；Balloonflower root dregs of a decoction alcohol extracting, filtering, is obtained To filtrate, filtrate concentration obtains alcohol-extracted extract；Above-mentioned inclusion compound and alcohol-extracted extract are mixed, Radix Platycodonis extract is obtained.
Described milkwort extract, which is prepared by the following method, to be obtained：Polygala is through CO2Supercritical extract obtains polygala Extract and the polygala dregs of a decoction, by polygala extract beta-cyclodextrin inclusion compound, obtain inclusion compound；Polygala dregs of a decoction alcohol extracting, filtering, is obtained To filtrate, filtrate concentration obtains alcohol-extracted extract；Above-mentioned inclusion compound and alcohol-extracted extract are mixed, milkwort extract is obtained.
Balloonflower root used in the present invention is Campanulaceae balloonflower root Platycodon grandiflorum (Jacq.) A.Dc.'s Dry root.Major function：Facilitaing lung, relieving sore-throat, eliminating the phlegm, apocenosis.For coughing with a lot of sputum, uncomfortable in chest not smooth, pharyngalgia sound is mute, lung carbuncle pyemesis. Polygala is milk wort polygala Polygala tenuifolia Willd. or ovum leaf polygala Polygala sibirica L. Dry root.Major function：Tranquilize the mind and promote the intelligence, restoring normal coordination between heart and kidney, eliminating the phlegm, detumescence.For insomnia and dreamful sleep caused by breakdown of the normal physiological coordination between the heart and the kidney, forgetful Palpitation with fear, it is wandering, expectoration is not well, sore swollen toxin, mastosis.
Above-mentioned have that cough-relieving apophlegmatic relievings asthma the pharmaceutical composition of effect and preparation is made in pharmaceutically acceptable auxiliary material.
It is above-mentioned that following formulation is made with the relieving asthma pharmaceutical composition of effect of cough-relieving apophlegmatic：Tablet, granule, capsule, Pill.
It is above-mentioned to comprise the following steps with the relieving asthma preparation method of pharmaceutical composition of effect of cough-relieving apophlegmatic：
(1) balloonflower root is through CO2Supercritical extract obtains balloonflower root extract and the balloonflower root dregs of a decoction, and balloonflower root extract is pasted with β-ring Spermatophore is closed, and obtains inclusion compound；Balloonflower root dregs of a decoction alcohol extracting, filtering obtains filtrate, and filtrate concentration obtains alcohol-extracted extract；By above-mentioned inclusion Thing and alcohol-extracted extract mixing, obtain Radix Platycodonis extract；
(2) polygala is through CO2Supercritical extract obtains polygala extract and the polygala dregs of a decoction, and polygala extract is pasted with β-ring Spermatophore is closed, and obtains inclusion compound；Polygala dregs of a decoction alcohol extracting, filtering obtains filtrate, and filtrate concentration obtains alcohol-extracted extract；By above-mentioned inclusion Thing and alcohol-extracted extract mixing, obtain milkwort extract；
(3) ephedrine hydrochloride is added, mixes, produces with Radix Platycodonis extract, milkwort extract.
It is above-mentioned with cough-relieving apophlegmatic relieving asthma effect pharmaceutical composition preparation method, the CO described in step (1)2It is overcritical Extraction conditions is：Extracting pressure is 25-35MPa, 30-45 DEG C of extraction temperature, CO2Flow 20-35L/h, extraction time 1-2h；Tangerine Stalk extract carries out inclusion condition with beta-schardinger dextrin and is：Ratio between balloonflower root extract and beta-schardinger dextrin is 1ml：4-6g, plus Water is measured as 4-8 times again, and the inclusion time is 15-45 minutes；Balloonflower root dregs of a decoction alcohol extracting condition is：Plus 6-10 times of weight of the balloonflower root dregs of a decoction 60%-90% ethanol heating and refluxing extraction 1-3 times, each 1-2 hours, phegma stands more than 12 hours, Aspirate supernatant, filter Cross, obtain filtrate；Filtrate is concentrated under reduced pressure into relative density 1.1-1.3 alcohol-extracted extract under the conditions of 60 DEG C.
It is preferred that step (1) described in CO2Supercritical extract condition is：Extracting pressure is 30-35MPa, extraction temperature 35- 45 DEG C, CO2Flow 25-35L/h, extraction time 1-1.5h；Balloonflower root extract carries out inclusion condition with beta-schardinger dextrin：Balloonflower root extracts It is 1ml to take the ratio between thing and beta-schardinger dextrin：4-5g, times amount that adds water is 6-8 times, and the inclusion time is 15-30 minutes；Balloonflower root medicine Slag alcohol extracting condition is：Plus 8-10 times of balloonflower root dregs of a decoction weight 70-90% ethanol heating and refluxing extraction 2-3 times, it is each 1.5-2 hours, Phegma stands more than 12 hours, Aspirate supernatant, filtration, obtains the dregs of a decoction and filtrate；Filtrate is concentrated under reduced pressure under the conditions of 60 DEG C To relative density 1.15-1.25 alcohol-extracted extract.
It is above-mentioned with cough-relieving apophlegmatic relieving asthma effect pharmaceutical composition preparation method, the polygala CO described in step (2)2It is super Critical extraction conditions is：Extracting pressure is 25-35MPa, 30-45 DEG C of extraction temperature, CO2Flow 20-35L/h, extraction time 1- 2h；Polygala extract carries out inclusion condition with beta-schardinger dextrin：Ratio between polygala extract and beta-schardinger dextrin is 1ml：4- 6g, times amount that adds water is 4-8 times, and the inclusion time is 15-45 minutes；Polygala dregs of a decoction alcohol extracting condition is：Plus 6-10 times of the polygala dregs of a decoction are weighed Measure 60%-90% ethanol heating and refluxing extraction 1-3 times, each 1-2 hours, phegma stands more than 12 hours, Aspirate supernatant, Filtration, obtains the dregs of a decoction and filtrate；Filtrate is concentrated under reduced pressure into relative density 1.1-1.3 alcohol-extracted extract under the conditions of 60 DEG C.
It is preferred that step (2) described in polygala CO2Supercritical extract condition is：Extracting pressure is 30-35MPa, extraction temperature 35-45 DEG C of degree, CO2Flow 25-35L/h, extraction time 1-1.5h；Polygala extract carries out inclusion condition with beta-schardinger dextrin： Ratio between polygala extract and beta-schardinger dextrin is 1ml：4-5g, times amount that adds water is 6-8 times, and the inclusion time is 15-30 minutes； Polygala dregs of a decoction alcohol extracting condition is：Plus 8-10 times of polygala dregs of a decoction weight 70%-90% ethanol heating and refluxing extraction 2-3 times, every time 1.5-2 hours, phegma stood more than 12 hours, Aspirate supernatant, and filtration obtains the dregs of a decoction and filtrate；Filtrate is in 60 DEG C of conditions Under be concentrated under reduced pressure into the alcohol-extracted extract of relative density 1.15~1.25.
It is above-mentioned to prepare treatment cough, expectoration with the relieving asthma pharmaceutical composition of effect of cough-relieving apophlegmatic, answering in asthma due to excessive phlegm medicine With with significant curative effect.
Beneficial effects of the present invention compared with the prior art：Pharmaceutical composition of the present invention has the work(that cough-relieving apophlegmatic is relievingd asthma Effect, therapeutic effect is good, persistent；Have no toxic side effect；Simple production process, balloonflower root, polygala are conventional Chinese medicine, and dose is low, Production cost is low.
Embodiment
The present invention is further detailed below by way of specific test example.
Embodiment 1
The pharmaceutical composition of effect of being relievingd asthma with cough-relieving apophlegmatic of the present embodiment production, is extracted by Radix Platycodonis extract, polygala Thing and ephedrine hydrochloride composition.
The preparation of the pharmaceutical composition is followed the steps below：
(1) balloonflower root utilizes CO2Supercritical extraction is extracted, and extracting pressure is 35MPa, 35 DEG C of extraction temperature, CO2Stream 25L/h, extraction time 1h are measured, balloonflower root extract and the balloonflower root dregs of a decoction are obtained, extract is included with beta-schardinger dextrin, extract Ratio between beta-schardinger dextrin is 1ml：4g, times amount that adds water is 6 times, bag and 20 minutes time, obtains inclusion compound；The balloonflower root dregs of a decoction Plus 8 times of 75% ethanol heating and refluxing extractions of weight 3 times, 2 hours every time, phegma stood more than 12 hours, Aspirate supernatant, filter Cross, obtain the dregs of a decoction and filtrate；Filtrate is concentrated under reduced pressure into relative density 1.15-1.25 alcohol-extracted extract under the conditions of 60 DEG C；Will be upper Inclusion compound and alcohol-extracted extract mixing are stated, Radix Platycodonis extract is obtained；
(2) polygala utilizes CO2Supercritical extraction is extracted, and extracting pressure is 35MPa, 35 DEG C of extraction temperature, CO2Stream 25L/h, extraction time 1.5h are measured, polygala extract and the polygala dregs of a decoction are obtained, extract is included with beta-schardinger dextrin, extracted Ratio between thing and beta-schardinger dextrin is 1ml：5g, times amount that adds water is 8 times, bag and 20 minutes time, obtains inclusion compound.Polygala medicine Slag adds 8 times of 85% ethanol heating and refluxing extractions of weight 3 times, 2 hours every time, and phegma stands more than 12 hours, Aspirate supernatant, Filtration, obtains the dregs of a decoction and filtrate；Filtrate is concentrated under reduced pressure into relative density 1.15-1.25 alcohol-extracted extract under the conditions of 60 DEG C；Will Above-mentioned inclusion compound and alcohol-extracted extract mixing, obtains milkwort extract；
(3) by the parts by weight of ephedrine hydrochloride 3, mixed with the parts by weight of Radix Platycodonis extract 30, the parts by weight of milkwort extract 20, i.e., .
Embodiment 2
The pharmaceutical composition of effect of being relievingd asthma with cough-relieving apophlegmatic of the present embodiment production, is extracted by Radix Platycodonis extract, polygala Thing and ephedrine hydrochloride composition.
The preparation of the pharmaceutical composition is followed the steps below：
(1) balloonflower root utilizes CO2Supercritical extraction is extracted, and extracting pressure is 30MPa, 45 DEG C of extraction temperature, CO2Stream 32L/h, extraction time 1.5h are measured, balloonflower root extract, and the balloonflower root dregs of a decoction are obtained, extract is included with beta-schardinger dextrin, extracted It is 1ml to take the ratio between thing and beta-schardinger dextrin：5g, times amount that adds water is 8 times, bag and 35 minutes time, obtains inclusion compound；Balloonflower root The dregs of a decoction add 10 times of 85% ethanol heating and refluxing extractions of weight 3 times, 1.5 hours every time, and phegma stands more than 12 hours, in absorption Clear liquid, filtration, obtains the dregs of a decoction and filtrate；Filtrate is concentrated under reduced pressure into relative density 1.15-1.25 alcohol extracting leaching under the conditions of 60 DEG C Cream；Above-mentioned inclusion compound and alcohol-extracted extract are mixed, Radix Platycodonis extract is obtained；
(2) polygala utilizes CO2Supercritical extraction is extracted, and extracting pressure is 30MPa, 45 DEG C of extraction temperature, CO2Stream 32L/h, extraction time 1.5h are measured, polygala extract, and the polygala dregs of a decoction are obtained, extract is included with beta-schardinger dextrin, extracted It is 1ml to take the ratio between thing and beta-schardinger dextrin：5g, times amount that adds water is 8 times, bag and 35 minutes time, obtains inclusion compound；Polygala The dregs of a decoction add 10 times of 85% ethanol heating and refluxing extractions of weight 3 times, 1.5 hours every time, and phegma stands more than 12 hours, in absorption Clear liquid, filtration, obtains the dregs of a decoction and filtrate；Filtrate is concentrated under reduced pressure into relative density 1.15-1.25 alcohol extracting leaching under the conditions of 60 DEG C Cream；Above-mentioned inclusion compound and alcohol-extracted extract are mixed, milkwort extract is obtained；
(3) by the parts by weight of ephedrine hydrochloride 15, mixed with the parts by weight of Radix Platycodonis extract 95, the parts by weight of milkwort extract 70, Produce.
Comparative example：Balloonflower root 150g is taken to be ground into fine powder, it is standby；Coarse powder is added water to cook three times, first and second time with polygala 100g Each 1.5 hours, third time 1 hour, collecting decoction, filtration, it is 1.32-1.35's (65 DEG C) that filtrate decompression, which is concentrated into relative density, Thick paste, adds balloonflower root fine powder and 15g ephedrine hydrochlorides, and mixing is produced.
Test antitussive action experiment
1. animal：Mouse, male and female half and half, 18~22g of body weight.
2. medicine：Pharmaceutical composition (being prepared according to the method for embodiment 1) of the present invention
3. comparative example：Prepared by prior art.
Method and result
1. ammoniacal liquor causes mouse cough experiment
1.1 packet：Mouse is randomly divided into 4 groups：Blank control group (waits appearance physiological saline group), aspirin group (0.1g/ Kg), pharmaceutical composition group (0.035g crude drugs/kg), four dosage groups of comparative example group (0.035g crude drugs/kg).
1.2 experimental method：Mouse is taken to be grouped at random, daily gastric infusion each 1 time sooner or later, successive administration 5 days is given on the 5th day 1h after medicine, mouse is placed in experimental box, and 25~28% ammoniacal liquor 20s are sprayed into experimental box, and record self-spray rises small in 5min Mouse incubation period and cough number of times.
1.3 result：Pharmaceutical composition group, comparative example group and positive drug aspirin group can significantly reduce ammoniacal liquor and cause mouse Cough number of times in 5min, extends cough latent period, has conspicuousness (P with blank control group comparing difference<0.05 or P< 0.01, it is shown in Table 1).
The influence that the pharmaceutical composition of table 1. is coughed to ammonia spraying induced mice
Note：Compared with blank control group, * P<0.05；**P<0.01
Pharmaceutical composition group can reduce the cough number of times that ammoniacal liquor causes mouse cough model, equal to each administration group of cough latent period There is extension effect, have conspicuousness with blank control group comparing difference.Point out the pharmaceutical composition that there is good antitussive action, with Comparative example group compares, and has conspicuousness progress.
Test the experiment of two resolve phlegm effects
1. animal：Mouse, male and female half and half, 18~22g of body weight.
2. medicine：Pharmaceutical composition (being prepared according to the method for embodiment 1) of the present invention.
3. comparative example：Prepared by prior art.
Method and result
1. the influence of the phenol red expectoration amount of pair mouse tracheae：
1.1 packet：Mouse is randomly divided into 4 groups：Blank control group (isometric(al) physiological saline), ammonium chloride group (1.0g/kg), Pharmaceutical composition group (0.035g crude drugs/kg), four dosage groups of comparative example group (0.035g crude drugs/kg).
1.2 experimental method：Mouse is taken to be grouped at random, daily gastric infusion each 1 time sooner or later, continuous 5 days, after administration in the 5th day 1h, mouse is put to death after 5% phenol red (0.1ml/10g body weight), 30min is injected intraperitoneally.Mouse is cut from thyroid cartilage to tracheorrhaphy One section of tracheae at branch, is put into the test tube for filling 2ml physiological saline, shaking, 0.1ml1mol/LNaOH is added, with 754 points Light photometer (Shanghai) surveys OD values under the conditions of wavelength 550nm.The phenol red discharge of tracheae that every mouse is found according to phenol red standard curve Amount.
1.3 experimental result：Pharmaceutical composition group, comparative example group, positive drug ammonium chloride group can substantially increase mouse tracheae Phenol red discharge rate, has conspicuousness (P with blank control group comparing difference<0.05 or P<0.01) (2 are shown in Table).
Influence of the pharmaceutical composition of table 2. to the phenol red expectoration amount of mouse tracheae
Note：Compared * P with blank control group<0.05；**P<0.01
Pharmaceutical composition can increase the liquid column length that capillary draws tracheal secretion.Point out the pharmaceutical composition that there is change Phlegm is acted on, and has certain help to improving symptom, being compared with comparative example group has marked improvement.
Test the experiment of three antiasthmatic effects
1. animal：Cavy, male and female half and half, 180~200g of body weight.
2. medicine：Pharmaceutical composition (being prepared according to the method for embodiment 1) of the present invention.
3. comparative example：Prepared by prior art.
Method and result
1. influence of the pharmaceutical composition to Experimental Asthma In Guinea-pigs
1.1 packet：Cavy is randomly divided into following 4 groups：Blank control group (isometric(al) physiological saline), positive drug aminophylline group (0.025g/kg), pharmaceutical composition group (0.042g crude drugs/kg), four dosage groups of comparative example group (0.042g crude drugs/kg).
1.2 method：Take cavy to be grouped at random, daily gastric infusion each 1 time sooner or later, continuous 5 days, the 5th day in after administration 1h, Cavy is placed in experimental box, 2% acecoline of atomization is sprayed into experimental box and 0.1% histamine phosphate's isometric(al) is mixed Close liquid 15s, asthmatic latent period after record administration.
1.3 result：Pharmaceutical composition, comparative example group and positive drug aminophylline group can be obviously prolonged drawing for cavy and breathe heavily latent Phase, there is conspicuousness (P with blank control group comparing difference<0.05 or P<0.01) (3 are shown in Table).
Influence of the pharmaceutical composition of table 3. to Experimental Asthma In Guinea-pigs
Note：Compared with blank control group, * P<0.05；**P<0.01；
Pharmaceutical composition can be obviously prolonged acecoline plus histamine phosphate causes the asthmatic latent period of cavy, and pointing out should Pharmaceutical composition may have antiasthmatic effect, and being compared with comparative example group has marked improvement.
Test the experiment of four antiinflammatory actions
1. animal：KM mouse, male and female half and half, 18~22g of body weight.
2. medicine：Pharmaceutical composition (being prepared according to the method for embodiment 1) of the present invention.
3. comparative example：Prepared by prior art.
Method and result
1. the influence of pharmaceutical composition paraxylene induced mice auricle edema
1.1 packet：In the lab by Mouse feeder one day to adapt to environment, then sub-cage rearing, is randomly divided into following 3 Group：Blank control group (isometric(al) physiological saline), positive drug indocin group (0.01625g/kg), pharmaceutical composition group (0.035g Crude drug/kg), four dosage groups of comparative example group (0.035g crude drugs/kg).
1.2 method：Take mouse to be grouped at random, daily gastric infusion each 1 time sooner or later, continuous 5 days, the 5th day in after administration 1h, Dimethylbenzene is applied to two sides before and after mouse right ear, per mouse 0.08ml, left ear is compared.Animal is put to death after 1h, is punched with 9mm diameters Device lays round auricle at same position respectively, uses scales/electronic balance weighing.Mice auricle swelling rate is calculated according to formula.
Swelling rate (100%)=(auris dextra weight-left ear weight)/left ear weight × 100%
Swelling inhibiting rate %=(control group swelling rate-administration group swelling rate)/control group swelling rate × 100%
1.3 result：Pharmaceutical composition group, comparative example group and positive drug indocin group, which have, substantially suppresses dimethylbenzene induced mice The effect of auricle edema, has conspicuousness (being shown in Table 4) with blank control group comparing difference.
The influence of the pharmaceutical composition paraxylene induced mice auricle edema rate of table 4.
Note：Compared with blank control group, * P<0.05；**P<0.01.
Pharmaceutical composition group, comparative example group and positive drug indocin group have different degrees of to chmice acute inflammatory model The increase of anti-inflammatory early stage capillary permeability, Inflammatory substances can be oozed out and tissue edema, point out the medicine by antagonism Composition may have preventive and therapeutic effect to acute inflammation, and being compared with comparative example group has marked improvement.
Clinical test
1. case selection standard
Primary symptom：Coughing with a lot of sputum, shortness of breath is panted
Secondary disease：Pharynx is itched or pain, uncomfortable in chest, and it is unfavorable to breathe, nasal obstruction, runny nose, fever with aversion to cold
Possess above primary symptom one, secondary disease 2, the age is in 18-60 year persons, you can.
2. therapeutic scheme
Administrated method：It is 0.27g/ pieces that the pharmaceutical composition prepared by embodiment 1, which adds appropriate amount of auxiliary materials to be made containing crude drug amount, Tablet, piece weight 0.28g, for clinical test.Orally, one at a time, 2 times a day.The course for the treatment of：Medication 5 days.
3. curative effect determinate standard
Recovery from illness：Observed clinical symptoms, sign disappear or basic disappearance, and disease total mark curative effect is more than 95%；
It is effective：Observed clinical symptoms, sign are obviously improved, and disease total mark curative effect is between 70%-95%；
Effectively：Observed clinical symptoms, sign take a favorable turn, and disease total mark curative effect is between 30%-70%；
It is invalid：Observed clinical symptoms, sign, which have no, to be obviously improved, or is aggravated on the contrary, and disease total mark curative effect is 30% Below.
Curative effect calculation formula：Integration * 100% before curative effect=(being integrated before treatment after integration-treatment)/treatment
4. efficacy result
The efficacy result table of table 5.
Note：300 cases do not occur any vomiting phenomenon in medication cycle.

Claims (10)

1. a kind of pharmaceutical composition of effect of being relievingd asthma with cough-relieving apophlegmatic, it is characterised in that the pharmaceutical composition is extracted by balloonflower root Thing, milkwort extract and ephedrine hydrochloride composition, wherein Radix Platycodonis extract is 15-100 parts by weight, and milkwort extract is 10-75 Parts by weight, ephedrine hydrochloride is 1-18 parts by weight.
2. the pharmaceutical composition of effect according to claim 1 of being relievingd asthma with cough-relieving apophlegmatic, it is characterised in that the medicine group Compound is made up of Radix Platycodonis extract, milkwort extract and ephedrine hydrochloride, and wherein Radix Platycodonis extract is 20-80 parts by weight, polygala Extract is 10-70 parts by weight, and ephedrine hydrochloride is 1-15 parts by weight.
3. the pharmaceutical composition of effect according to claim 1 or 2 of being relievingd asthma with cough-relieving apophlegmatic, it is characterised in that described Radix Platycodonis extract, which is prepared by the following method, to be obtained：Balloonflower root is through CO2Supercritical extract obtains balloonflower root extract and balloonflower root The dregs of a decoction, by balloonflower root extract beta-cyclodextrin inclusion compound, obtain inclusion compound；Balloonflower root dregs of a decoction alcohol extracting, filtering, obtains filtrate, filtrate is dense Contracting, obtains alcohol-extracted extract；Above-mentioned inclusion compound and alcohol-extracted extract are mixed, Radix Platycodonis extract is obtained.
4. the pharmaceutical composition of effect according to claim 1 or 2 of being relievingd asthma with cough-relieving apophlegmatic, it is characterised in that described Milkwort extract, which is prepared by the following method, to be obtained：Polygala is through CO2Supercritical extract obtains polygala extract and polygala The dregs of a decoction, by polygala extract beta-cyclodextrin inclusion compound, obtain inclusion compound；Polygala dregs of a decoction alcohol extracting, filtering, obtains filtrate, filtrate is dense Contracting, obtains alcohol-extracted extract；Above-mentioned inclusion compound and alcohol-extracted extract are mixed, milkwort extract is obtained.
5. the pharmaceutical composition of effect according to claim 1 or 2 of being relievingd asthma with cough-relieving apophlegmatic, it is characterised in that the medicine Preparation is made with pharmaceutically acceptable auxiliary material in composition.
6. the pharmaceutical composition of the effect of being relievingd asthma with cough-relieving apophlegmatic stated according to claim 5, it is characterised in that the drug regimen Following formulation is made in thing：Tablet, granule, capsule, pill.
7. described in a kind of claim 1 or 2 have cough-relieving apophlegmatic relieving asthma effect pharmaceutical composition preparation method, its feature It is that this method comprises the following steps：
(1) balloonflower root is through CO2Supercritical extract obtains balloonflower root extract and the balloonflower root dregs of a decoction, by balloonflower root extract beta-schardinger dextrin bag Close, obtain inclusion compound；Balloonflower root dregs of a decoction alcohol extracting, filtering obtains filtrate, and filtrate concentration obtains alcohol-extracted extract；By above-mentioned inclusion compound and Alcohol-extracted extract is mixed, and obtains Radix Platycodonis extract；
(2) polygala is through CO2Supercritical extract obtains polygala extract and the polygala dregs of a decoction, by polygala extract beta-schardinger dextrin bag Close, obtain inclusion compound；Polygala dregs of a decoction alcohol extracting, filtering obtains filtrate, and filtrate concentration obtains alcohol-extracted extract；By above-mentioned inclusion compound and Alcohol-extracted extract is mixed, and obtains milkwort extract；
(3) ephedrine hydrochloride is added, mixes, produces with Radix Platycodonis extract, milkwort extract.
8. it is according to claim 7 with cough-relieving apophlegmatic relieving asthma effect pharmaceutical composition preparation method, its feature exists In the CO described in step (1)2Supercritical extract condition is：Extracting pressure is 25-35MPa, 30-45 DEG C of extraction temperature, CO2Flow 20-35L/h, extraction time 1-2h；Described balloonflower root extract carries out inclusion condition with beta-schardinger dextrin：Balloonflower root extract and β- Ratio between cyclodextrin is 1ml：4-6g, times amount that adds water is 4-8 times, and the inclusion time is 15-45 minutes；The described balloonflower root dregs of a decoction Alcohol extracting condition is：Plus 6-10 times of balloonflower root dregs of a decoction weight 60%-90% ethanol heating and refluxing extraction 1-3 times, it is each 1-2 hours, return Flow liquid stands more than 12 hours, Aspirate supernatant, filtration, obtains filtrate；Filtrate is concentrated under reduced pressure into relatively close under the conditions of 60 DEG C Spend 1.1-1.3 alcohol-extracted extract.
9. it is according to claim 7 with cough-relieving apophlegmatic relieving asthma effect pharmaceutical composition preparation method, its feature exists In the polygala CO described in step (2)2Supercritical extract condition is：Extracting pressure is 25-35MPa, 30-45 DEG C of extraction temperature, CO2 Flow 20-35L/h, extraction time 1-2h；Described polygala extract carries out inclusion condition with beta-schardinger dextrin：Polygala extract Ratio between beta-schardinger dextrin is 1ml：4-6g, times amount that adds water is 4-8 times, and the inclusion time is 15-45 minutes；Described polygala Dregs of a decoction alcohol extracting condition is：Plus 6-10 times of polygala dregs of a decoction weight 60%-90% ethanol heating and refluxing extraction 1-3 times, each 1-2 is small When, phegma stands more than 12 hours, Aspirate supernatant, filtration, obtains the dregs of a decoction and filtrate；Filtrate is depressurized dense under the conditions of 60 DEG C It is reduced to relative density 1.1-1.3 alcohol-extracted extract.
10. described in claim 1 or 2 have cough-relieving apophlegmatic relieving asthma effect pharmaceutical composition prepare treatment cough, expectoration, Application in asthma due to excessive phlegm medicine.
CN201710385591.2A 2017-05-26 2017-05-26 A kind of pharmaceutical composition of effect of being relievingd asthma with cough-relieving apophlegmatic and preparation method thereof Pending CN107137465A (en)

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Citations (2)

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CN1943637A (en) * 2006-10-27 2007-04-11 宁夏金太阳药业有限公司 Medicine for eliminating sputum and relieving asthma and its preparing method
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Publication number Priority date Publication date Assignee Title
CN1943637A (en) * 2006-10-27 2007-04-11 宁夏金太阳药业有限公司 Medicine for eliminating sputum and relieving asthma and its preparing method
CN101033246A (en) * 2007-04-10 2007-09-12 山东理工大学 Method of extracting platycodin by supercritical carbon dioxide

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Application publication date: 20170908