CN109674847A - A kind of atomization medicine composition and preparation method thereof for treating cough and asthma - Google Patents
A kind of atomization medicine composition and preparation method thereof for treating cough and asthma Download PDFInfo
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Abstract
The invention belongs to pharmaceutical technology fields, it provides a kind of for treating the atomization medicine composition of cough and asthma, the atomization medicine composition for treating cough and asthma is by budesonide 300-600ug, bricalin 600-1200ug, ambroxol hydrochloride 10-15mg, Astragalus Root P.E 0.5-1mL, propylene glycol 0.5ml and physiological saline 10ml composition, the present invention also provides the preparation methods of the atomization medicine composition.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of atomization medicine composition for being used to prepare treatment cough and asthma.
Background technique
Cough variant asthma (Cough variant is also known as in cough variant asthma (Cough Type Asthma)
Asthma, CVA), Gluser in 1972 reports the disease for the first time and is named as cough variant asthma, refers to and is with chronic cough
A kind of specific type asthma of main or unique clinical manifestation.The whole world GINA(asthma prevention and treatment proposal) in be specifically identified to cough variation
Property asthma be asthma a kind of form, its pathophysiological change is as asthma, and continues Airway inflammatory response and gas
Road high response.When bronchial asthma starts morbidity, 5%~6% is mostly occurred using persistent cough as cardinal symptom
Night or morning are often irritable cough, are often misdiagnosed as bronchitis at this time.The more typical asthma of age of onset is height, about
There is 13% patient age to be greater than 50 years old, female middle-aged is more common.And in the Childhood, cough may be the only symptom of asthma, very
To being the tendency developed as bronchial asthma, the patient of hospital is also in rise appreciably.
Bronchial asthma (abbreviation asthma) is the airway allergic inflammation based on eosinophil, mast cell reaction
The disease being characterized with airway hyper-reaction.The different degrees of reversible obstruction of air flue is the feature of this disease.
According to investigations, in the asthmatic patient in China at least 20,000,000 or more, although asthma cannot eradicate, implement to control
For the purpose of disease assessment, three steps of disease treatment and disease surveillance, especially with the connection confirmed through global evidence-based medicine EBM
Therapeutic scheme is closed, asthma can control.
The drug for the treatment of asthma is being alleviated in stage of attack mostly based on warming lung and reducing phlegm, clearing heat and freeing lung, relieving asthma at present
Phase is mostly based on replenishing lungs and securing the exterior, strengthening the spleen and reducing phlegm, kidney-boosting tonic.Dosage form is mostly with decoction, powder, based on electuary and pill.
And use ultrasonic atomizatio popular in recent years, it is sucked by respiratory tract, drug is made directly to act on the administration mode of lesion,
Convenient and efficient but mostly in the majority with Western medicine, Chinese medical extract carries out the seldom of Neulized inhalation.
Radix Astragali, also known as continuous stilbene.Perennial herb, main root is plump, wooden, normal branch, canescence.Stem is upright, more points of top
Branch, has thin rib, by white pubescence.The medicinal history for having more than 2000 years so far of Radix Astragali, has enhancing body's immunity, protects
Liver, diuresis, anti-aging, resisting stress, decompression and wide antibacterial action.But the real evil Sheng of table, retention of dampness due to stagnation of QI, dyspepsia are stagnated, carbuncle
Subcutaneous ulcer from the beginning of or heat toxin such as still contains at real examples and the hyperactivity of yang due to yin deficiency person after bursting, clothes must be prohibited.
Main effective ingredient in astragalus polyose is polysaccharide and astragalin.Astragalin is divided into astragalin I, astragalin II, Huang
Stilbene glucoside IV.Wherein bioactivity most preferably astragalin IV, that is, Astragaloside IV.Astragaloside IV not only has the function of astragalus polyose,
Also some are the incomparable effects of astragalus polyose, and efficacy strength is conventional astragalus polyose more than 2 times, and antivirus action is even more
30 times of astragalus polyose.Since content is few, effect is good, even more there is the title of " super astragalus polyose ".
The disease resistance that Astragaloside IV can be enhanced immunity of organisms, improve body.
Can specificity and it is nonspecific exclude intrusion body foreign matter, have to specific immunity and nospecific immunity
Facilitation improves the disease resistance of body.It can promote the generation of body antibody, antibody forming cell's number and haemolysis can be made to measure
Value significantly increases.Astragaloside IV can also improve oxidation, improve GSH-PX, SOD activity in immune organ, improve immune anti-
Imperial and immune surveillance function.
Astragaloside IV can be antiviral.
Its antiviral principle: the function of stimulating expression of macrophage and T cell, Cytokines Production promote interleukins to lure
It is raw, and body is made to generate endogenous interferon, to achieve the purpose that antiviral.Astragaloside IV, which has, adjusts TH1 and TH2 cell
Unbalance function can promote the ability of virus induction He itself inducement interferon, can inhibit influenza virus growth and inhibit saliva
The effect of phytase activity, infected by influenza after birth function and influences virus to the absorption of sensitive cells and has penetrated obvious effect,
Infected by influenza, Coxsackie virus, vesicular stomatitis virus etc. have apparent antagonism, the energy with broad-spectrum antiviral
Power and non-evident effect.
Astragaloside IV can improve cardio-pulmonary function.
Reinforce cardiac contractile force, protection cardiac muscle, heart failure resistance.Also have the effects that protect liver, anti-inflammatory, analgesia.It can
As various viral and bacteriosis auxiliary therapeutic agent.Astragaloside IV is a kind of high-purity extracted from Radix Astragali
Drug has the title of " super astragalus polyose ".The disease resistance that Astragaloside IV can enhance immunity of organisms, improve body.
Budesonide (budesonide) is a glucocorticoid with efficient local anti-inflammatory effect, it can enhance endothelium
The stability of cell, smooth muscle cell and lysosome membrane inhibits immune response and reduces antibody synthesis, to make the allergy such as histamine
The release of active medium is reduced and activity reduces, and can mitigate the enzymatic processes excited when antigen-antibody combines, inhibits bronchus
Shrink substance synthesis and release and mitigate the contractile response of smooth muscle.Clinically it is used for Corticodependence or non-dependent
The bronchial asthma of property and asthmatic chronic bronchitis patient.
Terbutaline is mainly used for branch when bronchial asthma, asthmatic bronchitis and chronic obstructive lung illness
Tracheospasm treatment.
Ambroxol can promote the exclusion of thick secretions inside respiratory tract and the delay of reduction mucus, thus remarkably promote
Expectoration.Suitable for secreting abnormal and expectoration dysfunction acute, chronic respiratory disease with sputum.
Summary of the invention
It is high that the purpose of the present invention is to provide a kind of bioavilabilities, directly acts on lesions position, rapid-action, safer
The atomization preparation and preparation method thereof of effective treatment cough and asthma.
The present invention provides a kind of atomization medicine composition for being used to prepare treatment cough and asthma, by budesonide 300-600ug, sulphur
His woods 600-1200ug, ambroxol hydrochloride 10-15mg of sour Terbutaline, Astragalus Root P.E 0. 5-1mL, propylene glycol 0.5ml and
Physiological saline 10ml composition.
It is preferred that are as follows: by budesonide 300ug, his woods 600ug of bricalin, ambroxol hydrochloride 10mg, astragalus extraction
Object 0.5mL, propylene glycol 0.5ml and physiological saline 10ml composition.
Or preferably are as follows: by budesonide 500ug, his woods 1000ug, ambroxol hydrochloride 12mg of bricalin is yellow
Stilbene extract 1mL, propylene glycol 0.5ml and physiological saline 10ml composition.
Or preferably are as follows: by budesonide 600ug, his woods 1200ug, ambroxol hydrochloride 15mg of bricalin is yellow
Stilbene extract 1mL, propylene glycol 0.5ml and physiological saline 10ml composition.
Main become of Astragalus Root P.E therein is Astragaloside IV, and 1ml Astragalus Root P.E must not be less than containing Astragaloside IV
0.08mg。
The preparation method of Astragalus Root P.E therein is that Radix Astragali is taken to add water to cook, filtration, and ethanol precipitation is used in filtrate concentration
Processing, refrigeration are placed, and are recycled ethyl alcohol and are concentrated, are diluted with water for injection, and refrigeration is placed, filtration, and filtrate concentration adjusts pH value,
It boils, addition active carbon boils, filters, water for injection is added to make into 1000ml, filters, and adjusts pH value to filtration sterilizes, i.e.,
?.
The preparation method of atomization medicine composition for wherein treating cough and asthma is, by budesonide, his woods of bricalin,
Ambroxol hydrochloride, Astragalus Root P.E, propylene glycol are added in physiological saline and are uniformly mixed, and obtain Neulized inhalation liquid.
Propylene glycol of the present invention is diluent, and flu mainly at present clinically can not simply recognize bacterium very much
Infection or virus infection, mostly use the scheme of symptomatic treatment.It is even more symptomatic treatment first, spy of the invention for cough and asthma patient
Point is that existing can do combines on the basis of atomization medicine traditional Chinese medical theory to be added Astragalus Root P.E, Astragalus Root P.E it is main at
It is divided into Radix Astragali hepatitis A, improves cardio-pulmonary function using it, antiviral effect improves treated effect, while several drugs being rubbed up
It is used as Alevaire together, the convenience of medication can be improved, improve the compliance of patient, while reducing front several drugs
Dosage, toxic side effect is small.The Alevaire about Astragalus Root P.E and other drugs combined treatment cough and asthma is had no at present.
It is an advantage of the present invention to provide a kind of new atomization preparations for treating cough and asthma, and said preparation is that drug is dissolved in life
It manages in salt water, borrows atomizer in the form of an aerosol, through service portion is administered in oral or nasal inhalation delivery to respiratory tract or lung
Position reduces drug in the distribution of other histoorgans, and the drug concentration of local lesion is high, and for being relatively administered orally, atomization is inhaled
The treated effect for entering administration mode, which replies, to be improved, and is had safely and effectively, and bioavilability is high, the small feature of toxic side effect, because
And there is apparent advantage.
Experimental example 1 treats cough and asthma effect experiment
Beneficial effects of the present invention are further illustrated below by way of experimental example
The infant of patient diagnosis children's upper respiratory tract infection 136, the age 2-4 years old, for the course of disease less than 7 days, clinical manifestation was difference
The fever of degree, cough.It is divided into observation group and control group, 80 people of observation group, 56 people of control group according to medical sequence.
Observation group gives the Alevaire of the invention of the preparation of embodiment 2, and control group gives Budinad fog preparation, sucks
200 μ g 2 times a day, Terbutaline aerosol, each 0.1mg, 2 times a day with ambroxol oral liquid, each 2.5mL.The course for the treatment of is equal
It is 3 days.
Criterion of therapeutical effect:
Effective: without cough or only slight cough, no fever, congestion of throat are subsided；
Effective: treatment 3 days or more clinical symptoms and pharyngeal sign are clearly better；
Invalid: after treatment 3 days, clinical symptoms and pharyngeal sign are generated heat without in improvement or family without alleviation.
As a result it see the table below
Table one is treated children's upper respiratory tract infection curative effect and is compared
| Group | It is effective | Effectively | In vain | Total effective rate |
| Observation group | 25 | 44 | 10 | 86.25% |
| Control group | 10 | 23 | 23 | 58.93% |
Thus table, which can be seen that observation group and control group, has therapeutic effect to the infection of the upper respiratory tract, the wherein treatment of observation group
Significant effect is better than control group.
2 physical and chemical experiment of experimental example
Stability experiment
Thermal acceleration experiment
By three batches of samples of embodiment 2-4 respectively at 40 ± 2 DEG C of temperature, relatively under conditions of appropriateness 20 ± 2, place 6 months,
The 1st, 2,3, the 6 month the end of month respectively inspected the color and content for once investigating sample by random samples during test, and index meets the requirements.
Keep sample experiment
It after appearance and content are looked into the three lot sample product examines of embodiment 2-4, is placed at room temperature for, every three months checks once, prevents 6 months
Observation later, the results showed that its appearance and content are without significant change.
The above experiment shows that Alevaire physicochemical properties of the invention are stablized.
Specific embodiment
The preparation of 1 Astragalus Root P.E of embodiment
Preparation:
Radix Astragali 200g is taken, is added water to cook twice, 2 hours every time, collecting decoction filtered, and filtrate is concentrated into every 1ml and is equivalent to raw medicine
1~2g of material, it is secondary with ethanol precipitation processing, it is twice 75% containing amount of alcohol in solution, refrigeration is placed every time, recycles ethyl alcohol simultaneously
It is concentrated into every 1ml and is equivalent to crude drug 10g, be diluted to every 1ml with water for injection and be equivalent to 0.75~1g of crude drug, refrigeration is placed
14 hours, filtration, filtrate was concentrated into every 1ml and is equivalent to 5~6g of crude drug, lets cool, and adjusted pH value with 20% sodium hydroxide solution
It to 7.5, boils, 0.125% active carbon is added, boil 10 minutes, filter while hot, water for injection is added to make into 100ml, filter,
Adjust pH value to 7.5 with 20% sodium hydroxide solution again, filtration, encapsulating, sterilizing to get.It is every that this product is measured according to official method
1ml contains Astragaloside IV (C41H68O14) 0.095mg.
The preparation of 2 atomizable composition of embodiment
By budesonide 300ug, bricalin 600ug, ambroxol hydrochloride 10mg, 0. 5mL of Astragalus Root P.E, propylene glycol
0.5ml is added in 10mL physiological saline and is uniformly mixed, and obtains Neulized inhalation liquid.
After gained Neulized inhalation liquid is atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
The preparation of 3 atomizable composition of embodiment
By budesonide 600ug, bricalin 1200ug, ambroxol hydrochloride 15mg, Astragalus Root P.E 1mL, propylene glycol
0.5ml is added in 10mL physiological saline and is uniformly mixed, and obtains Neulized inhalation liquid.
After gained Neulized inhalation liquid is atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
The preparation of 4 atomizable composition of embodiment
By budesonide 500ug, bricalin 1000ug, ambroxol hydrochloride 12mg, Astragalus Root P.E 1mL, propylene glycol
0.5ml is added in 10mL physiological saline and is uniformly mixed, and obtains Neulized inhalation liquid.
After gained Neulized inhalation liquid is atomized with ultrasonic atomizer, respiratory system is directly sucked in atomised form.
Claims (7)
1. a kind of atomization medicine composition for being used to prepare treatment cough and asthma, which is characterized in that by budesonide 300-600ug, sulphur
Sour Terbutaline 600-1200ug, ambroxol hydrochloride 10-15mg, Astragalus Root P.E 0.5-1mL, propylene glycol 0.5ml and physiology salt
Water 10ml composition.
2. a kind of atomization medicine composition for being used to prepare treatment cough and asthma as described in claim 1, which is characterized in that by cloth
How moral 300ug, bricalin 600ug, ambroxol hydrochloride 10mg, Astragalus Root P.E 0.5mL, propylene glycol 0.5ml and physiology
Salt water 10ml composition.
3. a kind of atomization medicine composition for being used to prepare treatment cough and asthma as described in claim 1, which is characterized in that by cloth
How moral 500ug, bricalin 1000ug, ambroxol hydrochloride 12mg, Astragalus Root P.E 1mL, propylene glycol 0.5ml and physiology
Salt water 10ml composition.
4. a kind of atomization medicine composition for being used to prepare treatment cough and asthma as described in claim 1, which is characterized in that by cloth
How moral 600ug, bricalin 1200ug, ambroxol hydrochloride 15mg, Astragalus Root P.E 1mL, propylene glycol 0.5ml and physiology
Salt water 10ml composition.
5. a kind of atomization medicine composition for being used to prepare treatment cough and asthma as described in claim 1, which is characterized in that described
Main become of Astragalus Root P.E is Astragaloside IV, and 1ml Astragalus Root P.E must not be less than 0.08mg containing Astragaloside IV.
6. a kind of atomization medicine composition for being used to prepare treatment cough and asthma as described in claim 1, which is characterized in that described
The preparation method of Astragalus Root P.E is that Radix Astragali is taken to add water to cook, filtration, and filtrate concentration is handled with ethanol precipitation, and refrigeration is placed,
Recycling ethyl alcohol is simultaneously concentrated, and is diluted with water for injection, and refrigeration is placed, filtration, and filtrate concentration adjusts pH value, boils, activity is added
Charcoal boils, and filtration adds water for injection to make into 1000ml, filters, and adjusts pH value, filters, sterilizing.
7. a kind of preparation method for the atomization medicine composition for being used to prepare treatment cough and asthma, which is characterized in that by budesonide, sulphur
Sour Terbutaline, ambroxol hydrochloride, Astragalus Root P.E, propylene glycol are added in physiological saline and are uniformly mixed, and obtain Neulized inhalation liquid.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110575446A (en) * | 2019-09-09 | 2019-12-17 | 上海臣邦医药科技股份有限公司 | compound inhalation composition and preparation method thereof |
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| CN110575446A (en) * | 2019-09-09 | 2019-12-17 | 上海臣邦医药科技股份有限公司 | compound inhalation composition and preparation method thereof |
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Application publication date: 20190426 |