CN105456240A - Ambroxol and salbutamol aerosol - Google Patents
Ambroxol and salbutamol aerosol Download PDFInfo
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- CN105456240A CN105456240A CN201510901472.9A CN201510901472A CN105456240A CN 105456240 A CN105456240 A CN 105456240A CN 201510901472 A CN201510901472 A CN 201510901472A CN 105456240 A CN105456240 A CN 105456240A
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- 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/12—Aerosols; Foams
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Abstract
The invention relates to an ambroxol and salbutamol aerosol, and belongs to the field of a pharmaceutical preparation. The aerosol consists of ambroxol hydrochloride, salbutamol sulfate, ethanol, propanediol, sodium dodecyl sulfate, polyvinyl pyrrolidone (PVP), vitamin C, methyl parahydroxybenzoats, apple essence, F12 and like components. The aerosol is stable in quality and significant in effect, and the aerosol is capable of effectively treating such diseases of respiratory system as acute and chronic bronchitis, asthma and the like.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of ambroxol albuterol aerosol and preparation method thereof.
Background technology
Respiratory system disease is a kind of commonly encountered diseases, frequently-occurring disease, and major lesions is in trachea-bronchial epithelial cell, pulmonary and thoracic cavity, and the many coughs of pathological changes the lighter, chest pain, breathing are influenced, severe one dyspnea, anoxia, even respiratory failure and lethal.Account for the 3rd at the mortality rate in city, then account for first place in rural area.What more should pay attention to is, due to atmospheric pollution, smoking, aged tendency of population and other factors, chronic obstructive pulmonary disease both domestic and external is made (to be called for short chronic obstructive pulmonary disease, comprise chronic bronchitis, emphysema, pulmonary heart disease), bronchial asthma, pulmonary carcinoma, pulmonary's dispersivity interstitial fibrosis, and the sickness rate of the disease such as pulmonary infection, mortality rate are growing on and on.
According to the statistical number of national urbans in 2006 and the rural area top ten principal disease cause of death, respiratory system disease (not comprising pulmonary carcinoma) accounts for the 4th (13.1%) in the Death causes in city, accounts for the 3rd (16.4%) in rural area.The physical and chemical factor caused due to atmospheric pollution, smoking, Industrial Economic Development, biotic factor inhale people and the factor such as population ages is aging, the sickness rate of respiratory system disease as pulmonary carcinoma, bronchial asthma in recent years is obviously increased, and chronic obstructive pulmonary disease remains high (more than 8% in more than 40 years old crowd).Though pulmonary tuberculosis rate controls to some extent, in recent years have again and increase trend.Pulmonary thromboembolism has constituted important health care problem, and pulmonary hypertension also receives publicity in recent years day by day.The disease incidences such as pulmonary Diffuse interstitial fibrosis and immunocompromised pulmonary infection day by day increase.The major causes of death of acquired immune deficiency syndrome (AIDS) is pulmonary infection, particularly pneumocystis carinii pneumonia.Since the end of the year 2002, severe acute respiratory syndrome (the severe acute respiratory syndrome broken out in China and world wide, SARS) epidemic situation, the young and the middle aged is born in due to multiple, its infectiousness is strong, and case fatality rate is high, lacks again medicine targetedly, thus cause the fear of the masses, bring about great losses to national economy simultaneously.The current human and bird fluenza case fatality rate occurred in multiple country is more than 60%.And bird flu virus to invade target organ main in human body be also lung.It is very large that this is just illustrating that respiratory system disease is still our people's health hazard, and it prevents and treats arduous task.
Ambroxol hydrochloride (AmbroxolHydrochloride) is also known as AMB, chemistry trans-4-[(2-amino 3 by name, 5-dibromo-benzyl) amino] cyclohexanol hydrochloridumi, it is active metabolite (the N-demethyl of expectorant bromhexine, trans hydroxyl is introduced in cyclohexyl para-position), toxicity is lower than bromhexine, and activity is higher than bromhexine.Ambroxol hydrochloride is the mucolytic researched and developed by German Boehringer Ingelheim company, first this medicine went on the market in Germany in early 1980s, in succession go on the market in many countries such as France, Italy, Japan, Spain subsequently, it is the glutinous expectorant lytic agent of a new generation, can expectoration be improved, and there is the effect promoting pulmonary surfactant and Airway secretion and ciliary movement.Ambroxol hydrochloride can regulate mucus to secrete with glutinous slurry clinically, and activation fibre swing is easy to dilute sputum, and strengthening mucus outwards transports, and be easy to discharge, it also can promote that pulmonary surfactant synthesizes, and to maintain alveolar tension, ensures lung functions index; Promote that antibiotic is to tissue infiltration, to improve concentration, strengthen bactericidal action; Antioxidation, reduces inflammatory mediator release, with the reaction that reduces inflammation; Work in coordination with bronchus spasmolysis material, to improve the curative effect of spasmolytic medicine.Therefore, this medicine can be widely used in the acute and chronic respiratory tract disease with respiratory tract abnormal secretion clinically, the particularly treatment of eliminating the phlegm of chronic bronchitis, the auxiliary treatment of transient respiratory distress of the newborn disease and pulmonary surgery, have that toxicity is low, determined curative effect can with antibiotic and with producing the advantages such as good synergy, be one of the most frequently used expectorant.In recent years in the emphasis hospital administration rank of China main cities, it ranked forefront always.Existing dosage form has oral liquid, tablet, capsule, micropill etc.
Salbutamol sulfate (SalbutamolSulfate) has another name called salbutamol, its main component is albuterol, chemistry 1-(4-hydroxyl-3-hydroxymethyl phenyl)-2-(tert-butylamine base) ethanol by name, a kind of β-adrenoreceptor analeptic of exciting bronchial smooth muscle of high selectivity, bronchial smooth muscle is relaxed, thus removes bronchial muscular spasm.Comparatively strong to bronchiectatic activity, and more weak to the β1-receptor effect of heart, be anti-asthmatic safer, the most frequently used at present.Be applicable to prevent and treat bronchial asthma, the bronchospasm of asthmatic bronchitis and emphysematic patients, the symptoms such as the dyspnea that alleviation causes because of airway obstructive diseases such as bronchial asthma, chronic bronchitis and emphysema, its advantage is rapid-action, patient symptom can be improved rapidly, spasmolytic, relieving asthma, eliminate the phlegm, shortcoming acts on lasting, only plays the effect alleviating patient's symptoms of asthma; Long period application can cause beta-receptor to regulate downwards, makes patient occur losing quick to beta receptor agonist, even invalid to treating asthma drug resistance phenomenon.Present existing dosage form has tablet, controlled release tablet, aerosol etc.
The problems such as although there is the aerosol containing ambroxol hydrochloride and salbutamol sulfate in prior art, still existence and stability is poor, and difficult quality controls, and effect is unstable.
Summary of the invention
Namely object of the present invention is to provide a kind of safe and effective, steady quality, and patient adaptability is strong, and Be very effective, effectively can treat the ambroxol albuterol aerosol of the respiratory system disease such as acute/chronic bronchitis and asthma.
The technical scheme that the present invention solves this technical problem is:
A kind of ambroxol albuterol aerosol, be prepared from by following component: ambroxol hydrochloride 50-80g, salbutamol sulfate 50-80g, ethanol 100-200g, propylene glycol 100-200g, dodecyl sodium sulfate 10-20g, PVP10-20g, vitamin C 5-10g, methyl parahydroxybenzoate 0.5-1g, apple essence 1-2g, F12 are appropriate, Purified Water q. s.
Preferably, be prepared from by following component: ambroxol hydrochloride 60g, salbutamol sulfate 60g, ethanol 150g, propylene glycol 150g, dodecyl sodium sulfate 15g, PVP15g, vitamin C 8g, methyl parahydroxybenzoate 0.5g, apple essence 1g, F12 are appropriate, Purified Water q. s.
The preparation method of described ambroxol albuterol aerosol is: ambroxol hydrochloride and salbutamol sulfate were pulverized 200 mesh sieves, add stirring and dissolving in purified water even, then add ethanol, propylene glycol, dodecyl sodium sulfate, PVP, vitamin C and methyl parahydroxybenzoate, under high-shear homogenizing machine, homogenizing stir about 30min, adds apple essence, continue stir about 20min, valve is pricked in fill, and fill propellant F12, leak detection is weighed, mobility aid is installed, obtains final product.
The invention has the beneficial effects as follows described ambroxol albuterol aerosol steady quality, Be very effective, can effectively treat the respiratory system disease such as acute/chronic bronchitis and asthma.
Detailed description of the invention
Below in conjunction with specific embodiment, set forth the present invention further.Should be understood that these embodiments are only not used in for illustration of the present invention to limit the scope of the invention.The experimental technique of unreceipted actual conditions in the following example, the usually conveniently conditioned disjunction condition of advising according to manufacturer.Unless otherwise indicated, otherwise all percent, ratio, ratio or number by weight.
Unless otherwise defined, all specialties used in literary composition and scientific words and one skilled in the art the same meaning be familiar with.In addition, any method similar or impartial to described content and material all can be applicable in the inventive method.The use that better implementation method described in literary composition and material only present a demonstration.
Embodiment 1
Each component is taken: ambroxol hydrochloride 50g by following weight proportion, salbutamol sulfate 50g, ethanol 100g, propylene glycol 100g, dodecyl sodium sulfate 10g, PVP10g, vitamin C 5g, methyl parahydroxybenzoate 0.5g, apple essence 1g, F12 is appropriate, Purified Water q. s, ambroxol hydrochloride and salbutamol sulfate were pulverized 200 mesh sieves, add stirring and dissolving in purified water even, then ethanol is added, propylene glycol, dodecyl sodium sulfate, PVP, vitamin C and methyl parahydroxybenzoate, homogenizing stir about 30min under high-shear homogenizing machine, add apple essence, continue stir about 20min, valve is pricked in fill, fill propellant F12, leak detection is weighed, mobility aid is installed, obtain.
Embodiment 2
Each component is taken: ambroxol hydrochloride 60g by following weight proportion, salbutamol sulfate 60g, ethanol 150g, propylene glycol 150g, dodecyl sodium sulfate 15g, PVP15g, vitamin C 8g, methyl parahydroxybenzoate 0.5g, apple essence 1g, F12 is appropriate, Purified Water q. s, ambroxol hydrochloride and salbutamol sulfate were pulverized 200 mesh sieves, add stirring and dissolving in purified water even, then ethanol is added, propylene glycol, dodecyl sodium sulfate, PVP, vitamin C and methyl parahydroxybenzoate, homogenizing stir about 30min under high-shear homogenizing machine, add apple essence, continue stir about 20min, valve is pricked in fill, fill propellant F12, leak detection is weighed, mobility aid is installed, obtain.
Embodiment 3
Each component is taken: ambroxol hydrochloride 80g by following weight proportion, salbutamol sulfate 80g, ethanol 200g, propylene glycol 200g, dodecyl sodium sulfate 20g, PVP20g, vitamin C 10g, methyl parahydroxybenzoate 1g, apple essence 2g, F12 is appropriate, Purified Water q. s, ambroxol hydrochloride and salbutamol sulfate were pulverized 200 mesh sieves, add stirring and dissolving in purified water even, then ethanol is added, propylene glycol, dodecyl sodium sulfate, PVP, vitamin C and methyl parahydroxybenzoate, homogenizing stir about 30min under high-shear homogenizing machine, add apple essence, continue stir about 20min, valve is pricked in fill, fill propellant F12, leak detection is weighed, mobility aid is installed, obtain.
Embodiment 4: stability test
1. influence factor's test
Embodiment 2 gained ambroxol albuterol aerosol is placed in low temperature (4 DEG C), high light (4500lx), high temperature (60 DEG C) and high humidity (RH75%) condition lower 10 days respectively by commercially available back, respectively at sampling in the 0th, 5,10 day, detect and often press every quality index such as drug content, drug content, related substance, the results are shown in Table 1.
Table 1 ambroxol albuterol aerosol influence factor result of the test
Result shows: ambroxol albuterol aerosol is placed 10 days respectively by by commercially available back under high temperature (60 DEG C), low temperature (4 DEG C), high light (4500lx), high humidity (RH75%) condition, detect every quality index, compared with 0 day, except high temperature (60 DEG C) related substance slightly increases and the content of ambroxol hydrochloride and salbutamol sulfate declines to some extent, other every quality index have no significant change.
2. accelerated test
By embodiment 2 gained ambroxol albuterol aerosol by commercially available back be placed in 40 DEG C, the constant temperature of RH20%, constant humidity cabinet 6 months, respectively at the 0th, sampling in 1,2,3,6 month, measure and often press every quality index such as drug content, drug content, related substance, the results are shown in Table 2.
Table 2 ambroxol albuterol aerosol accelerated test result
Result shows: ambroxol albuterol aerosol by commercially available back 40 DEG C, place 6 months under the condition of RH20%, compared with 0 month, except related substance slightly increases, other every quality index have no significant change, and steady quality is reliable, conforms with the regulations.
3. long term test
Embodiment 2 gained ambroxol albuterol aerosol is placed in 25 DEG C, the environment of RH60% by commercially available back, respectively at the 0th, sampling in 3,6,9,12,18,24 months, check and often press every quality index such as drug content, drug content, related substance, the results are shown in Table 3.
Table 3 ambroxol albuterol aerosol long-term test results
Result shows: ambroxol albuterol aerosol by commercially available back 25 DEG C, place 36 months in RH60% environment, indices compared with 0 month and has no significant change, and steady quality reliably, conforms with the regulations.
The phenol red secretory volume pharmacological testing of embodiment 5 mice trachea
After phenol red to mouse peritoneal injection indicator, the latter can partly discharge from trachea secretion.Ambroxol hydrochloride and salbutamol sulfate can strengthen the secretory function of respiratory tract, thus the excretion amount that corresponding increase is phenol red.After sodium bicarbonate solution lavation trachea, irrigating solution is developed the color, detect OD value with spectrophotometer, check in phenol red excretion amount, thus the phlegm-dispelling functions of medicine can be checked.
Experimental technique: get 60 mices and be divided into 6 groups at random, be respectively blank group, ambroxol hydrochloride group, salbutamol sulfate group, embodiment 2 does not fill basic, normal, high three the dosage groups of compositions of propellant, weigh, labelling, dosage is as shown in table 4, blank group gives normal saline, and administering mode is gavage.After 30min, lumbar injection phenol red solution 0.1mL/10g respectively, after 30min, put to death animal, polish No. 7 syringe needles are inserted trachea and are about 0.3cm by anatomical isolation trachea under larynx, after fixing with silk thread ligation, sodium bicarbonate solution 0.5mL is extracted with 1mL syringe, by syringe needle lavation respiratory tract 3 times back and forth, last 1 time irrigating solution is extracted out in injecting tube, continuous 3 times of aforesaid operations, rinse 9 times altogether, take out irrigating solution is about 1.2-1.5mL, be placed in test tube, centrifugal, with 721 type spectrophotometers, wavelength 546nm, read trap OD value.Standard curve is checked corresponding phenol red concentration, respectively organizes the difference of trachea section phenols contents.Result is as shown in table 4.
The phenol red secretory volume result of the test of table 4 mice trachea
| Group | Dosage (mg/kg) | Phenol red amount (μ g/mL) | Recruitment (%) |
| Blank group | -- | 0.58±0.23 | -- |
| Ambroxol hydrochloride group | 20 | 0.76±0.31 | 31.04 |
| Salbutamol sulfate group | 20 | 0.77±0.26 | 32.76 |
| Compositions low dose group | 20 | 0.84±0.41 | 44.83 |
| Dosage group in compositions | 40 | 0.99±0.27 | 70.69 |
| Compositions high dose group | 60 | 1.24±0.32 | 113.81 |
Experimental result: result shows that each administration group obviously can both increase the phenol red secretory volume of Respiratory Tract of Mice, wherein basic, normal, high three the dosage groups of compositions of the present invention act on and strengthening compared with alone ambroxol hydrochloride group or salbutamol sulfate group, significant difference, and action effect is relevant with the dosage of each compositions, effect of high dosage is best.
The foregoing is only preferred embodiment of the present invention, and be not used to limit substantial technological context of the present invention, substantial technological content of the present invention is broadly defined in the right of application, any technology entities that other people complete or method, if with application right define identical, also or a kind of change of equivalence, be all covered by being regarded as among this right.
Claims (2)
1. an ambroxol albuterol aerosol, is characterized in that, is prepared from by following component: ambroxol hydrochloride 50-80g, salbutamol sulfate 50-80g, ethanol 100-200g, propylene glycol 100-200g, dodecyl sodium sulfate 10-20g, PVP10-20g, vitamin C 5-10g, methyl parahydroxybenzoate 0.5-1g, apple essence 1-2g, F12 is appropriate, Purified Water q. s.
2. the preparation method of ambroxol albuterol aerosol according to claim 1, is characterized in that, is prepared from by following component: ambroxol hydrochloride 60g, salbutamol sulfate 60g, ethanol 150g, propylene glycol 150g, dodecyl sodium sulfate 15g, PVP15g, vitamin C 8g, methyl parahydroxybenzoate 0.5g, apple essence 1g, F12 is appropriate, Purified Water q. s.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107669636A (en) * | 2016-09-30 | 2018-02-09 | 青岛大学 | A kind of ambroxol spray |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101511183A (en) * | 2006-06-27 | 2009-08-19 | 先灵-普劳健康护理产品公司 | Aerosol lotion formulations |
| CN101810603A (en) * | 2009-02-25 | 2010-08-25 | 北京利乐生制药科技有限公司 | Aerosol taking salbutamol and ambroxol as active ingredients |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101511183A (en) * | 2006-06-27 | 2009-08-19 | 先灵-普劳健康护理产品公司 | Aerosol lotion formulations |
| CN101810603A (en) * | 2009-02-25 | 2010-08-25 | 北京利乐生制药科技有限公司 | Aerosol taking salbutamol and ambroxol as active ingredients |
Non-Patent Citations (1)
| Title |
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| 蒋国民: "《气雾剂理论与技术》", 31 January 2011, 化学工业出版社 * |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107669636A (en) * | 2016-09-30 | 2018-02-09 | 青岛大学 | A kind of ambroxol spray |
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