CN101810603A - Aerosol taking salbutamol and ambroxol as active ingredients - Google Patents
Aerosol taking salbutamol and ambroxol as active ingredients Download PDFInfo
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- CN101810603A CN101810603A CN200910078514A CN200910078514A CN101810603A CN 101810603 A CN101810603 A CN 101810603A CN 200910078514 A CN200910078514 A CN 200910078514A CN 200910078514 A CN200910078514 A CN 200910078514A CN 101810603 A CN101810603 A CN 101810603A
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- CN
- China
- Prior art keywords
- aerosol
- ambroxol
- tween
- propellant
- add
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- 239000000443 aerosol Substances 0.000 title claims abstract description 36
- NDAUXUAQIAJITI-UHFFFAOYSA-N albuterol Chemical compound CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 NDAUXUAQIAJITI-UHFFFAOYSA-N 0.000 title claims abstract description 16
- 229960005174 ambroxol Drugs 0.000 title claims abstract description 16
- 229960002052 salbutamol Drugs 0.000 title claims abstract description 16
- JBDGDEWWOUBZPM-XYPYZODXSA-N ambroxol Chemical compound NC1=C(Br)C=C(Br)C=C1CN[C@@H]1CC[C@@H](O)CC1 JBDGDEWWOUBZPM-XYPYZODXSA-N 0.000 title claims abstract description 13
- 239000004480 active ingredient Substances 0.000 title abstract 3
- 150000003839 salts Chemical class 0.000 claims abstract description 6
- 239000003380 propellant Substances 0.000 claims description 12
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 11
- QNVKOSLOVOTXKF-UHFFFAOYSA-N 4-[(2-amino-3,5-dibromophenyl)methylamino]cyclohexan-1-ol;hydron;chloride Chemical compound Cl.NC1=C(Br)C=C(Br)C=C1CNC1CCC(O)CC1 QNVKOSLOVOTXKF-UHFFFAOYSA-N 0.000 claims description 10
- 229960000985 ambroxol hydrochloride Drugs 0.000 claims description 10
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 9
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 9
- 238000002360 preparation method Methods 0.000 claims description 9
- 239000004094 surface-active agent Substances 0.000 claims description 9
- BNPSSFBOAGDEEL-UHFFFAOYSA-N albuterol sulfate Chemical compound OS(O)(=O)=O.CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1.CC(C)(C)NCC(O)C1=CC=C(O)C(CO)=C1 BNPSSFBOAGDEEL-UHFFFAOYSA-N 0.000 claims description 8
- 239000003381 stabilizer Substances 0.000 claims description 8
- LVGUZGTVOIAKKC-UHFFFAOYSA-N 1,1,1,2-tetrafluoroethane Chemical compound FCC(F)(F)F LVGUZGTVOIAKKC-UHFFFAOYSA-N 0.000 claims description 6
- -1 correctives Substances 0.000 claims description 6
- 239000012467 final product Substances 0.000 claims description 5
- 239000000203 mixture Substances 0.000 claims description 5
- ATUOYWHBWRKTHZ-UHFFFAOYSA-N Propane Chemical compound CCC ATUOYWHBWRKTHZ-UHFFFAOYSA-N 0.000 claims description 4
- 229960000935 dehydrated alcohol Drugs 0.000 claims description 4
- UKACHOXRXFQJFN-UHFFFAOYSA-N heptafluoropropane Chemical compound FC(F)C(F)(F)C(F)(F)F UKACHOXRXFQJFN-UHFFFAOYSA-N 0.000 claims description 4
- NNPPMTNAJDCUHE-UHFFFAOYSA-N isobutane Chemical compound CC(C)C NNPPMTNAJDCUHE-UHFFFAOYSA-N 0.000 claims description 4
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 4
- 229920000053 polysorbate 80 Polymers 0.000 claims description 4
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 4
- 239000000375 suspending agent Substances 0.000 claims description 4
- 239000002202 Polyethylene glycol Substances 0.000 claims description 3
- 229960004756 ethanol Drugs 0.000 claims description 3
- 238000009472 formulation Methods 0.000 claims description 3
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 3
- 229920001223 polyethylene glycol Polymers 0.000 claims description 3
- WRIDQFICGBMAFQ-UHFFFAOYSA-N (E)-8-Octadecenoic acid Natural products CCCCCCCCCC=CCCCCCCC(O)=O WRIDQFICGBMAFQ-UHFFFAOYSA-N 0.000 claims description 2
- LQJBNNIYVWPHFW-UHFFFAOYSA-N 20:1omega9c fatty acid Natural products CCCCCCCCCCC=CCCCCCCCC(O)=O LQJBNNIYVWPHFW-UHFFFAOYSA-N 0.000 claims description 2
- QSBYPNXLFMSGKH-UHFFFAOYSA-N 9-Heptadecensaeure Natural products CCCCCCCC=CCCCCCCCC(O)=O QSBYPNXLFMSGKH-UHFFFAOYSA-N 0.000 claims description 2
- XEUCQOBUZPQUMQ-UHFFFAOYSA-N Glycolone Chemical compound COC1=C(CC=C(C)C)C(=O)NC2=C1C=CC=C2OC XEUCQOBUZPQUMQ-UHFFFAOYSA-N 0.000 claims description 2
- UWIULCYKVGIOPW-UHFFFAOYSA-N Glycolone Natural products CCOC1=C(CC=CC)C(=O)N(C)c2c(O)cccc12 UWIULCYKVGIOPW-UHFFFAOYSA-N 0.000 claims description 2
- ZQPPMHVWECSIRJ-UHFFFAOYSA-N Oleic acid Natural products CCCCCCCCC=CCCCCCCCC(O)=O ZQPPMHVWECSIRJ-UHFFFAOYSA-N 0.000 claims description 2
- 239000005642 Oleic acid Substances 0.000 claims description 2
- 229920001213 Polysorbate 20 Polymers 0.000 claims description 2
- NWGKJDSIEKMTRX-AAZCQSIUSA-N Sorbitan monooleate Chemical compound CCCCCCCC\C=C/CCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O NWGKJDSIEKMTRX-AAZCQSIUSA-N 0.000 claims description 2
- IYFATESGLOUGBX-YVNJGZBMSA-N Sorbitan monopalmitate Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O IYFATESGLOUGBX-YVNJGZBMSA-N 0.000 claims description 2
- QAOWNCQODCNURD-UHFFFAOYSA-L Sulfate Chemical compound [O-]S([O-])(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-L 0.000 claims description 2
- LWZFANDGMFTDAV-BURFUSLBSA-N [(2r)-2-[(2r,3r,4s)-3,4-dihydroxyoxolan-2-yl]-2-hydroxyethyl] dodecanoate Chemical compound CCCCCCCCCCCC(=O)OC[C@@H](O)[C@H]1OC[C@H](O)[C@H]1O LWZFANDGMFTDAV-BURFUSLBSA-N 0.000 claims description 2
- 239000003795 chemical substances by application Substances 0.000 claims description 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 2
- 229960003943 hypromellose Drugs 0.000 claims description 2
- 239000001282 iso-butane Substances 0.000 claims description 2
- 235000013847 iso-butane Nutrition 0.000 claims description 2
- QXJSBBXBKPUZAA-UHFFFAOYSA-N isooleic acid Natural products CCCCCCCC=CCCCCCCCCC(O)=O QXJSBBXBKPUZAA-UHFFFAOYSA-N 0.000 claims description 2
- 229920000609 methyl cellulose Polymers 0.000 claims description 2
- 239000001923 methylcellulose Substances 0.000 claims description 2
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 claims description 2
- 150000003904 phospholipids Chemical class 0.000 claims description 2
- 239000000256 polyoxyethylene sorbitan monolaurate Substances 0.000 claims description 2
- 235000010486 polyoxyethylene sorbitan monolaurate Nutrition 0.000 claims description 2
- IJDNQMDRQITEOD-UHFFFAOYSA-N sec-butylidene Natural products CCCC IJDNQMDRQITEOD-UHFFFAOYSA-N 0.000 claims description 2
- 229920001214 Polysorbate 60 Polymers 0.000 claims 1
- 239000000725 suspension Substances 0.000 claims 1
- 150000004677 hydrates Chemical class 0.000 abstract 2
- 239000000463 material Substances 0.000 abstract 2
- 238000007664 blowing Methods 0.000 abstract 1
- 239000002994 raw material Substances 0.000 abstract 1
- 201000010099 disease Diseases 0.000 description 9
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 9
- 208000023504 respiratory system disease Diseases 0.000 description 6
- 208000006673 asthma Diseases 0.000 description 5
- 239000003814 drug Substances 0.000 description 5
- 230000000694 effects Effects 0.000 description 5
- QGZKDVFQNNGYKY-UHFFFAOYSA-N Ammonia Chemical compound N QGZKDVFQNNGYKY-UHFFFAOYSA-N 0.000 description 4
- 206010025482 malaise Diseases 0.000 description 4
- 238000003756 stirring Methods 0.000 description 4
- 208000006545 Chronic Obstructive Pulmonary Disease Diseases 0.000 description 3
- 206010058467 Lung neoplasm malignant Diseases 0.000 description 3
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 3
- 239000002253 acid Substances 0.000 description 3
- 206010006451 bronchitis Diseases 0.000 description 3
- 208000030603 inherited susceptibility to asthma Diseases 0.000 description 3
- 230000000241 respiratory effect Effects 0.000 description 3
- 229910052717 sulfur Inorganic materials 0.000 description 3
- 239000011593 sulfur Substances 0.000 description 3
- 206010006458 Bronchitis chronic Diseases 0.000 description 2
- 206010014561 Emphysema Diseases 0.000 description 2
- 206010028980 Neoplasm Diseases 0.000 description 2
- 206010035664 Pneumonia Diseases 0.000 description 2
- 206010038687 Respiratory distress Diseases 0.000 description 2
- 229910021529 ammonia Inorganic materials 0.000 description 2
- 208000007451 chronic bronchitis Diseases 0.000 description 2
- 229920000136 polysorbate Polymers 0.000 description 2
- 230000000391 smoking effect Effects 0.000 description 2
- 210000002460 smooth muscle Anatomy 0.000 description 2
- WKBOTKDWSSQWDR-UHFFFAOYSA-N Bromine atom Chemical compound [Br] WKBOTKDWSSQWDR-UHFFFAOYSA-N 0.000 description 1
- 206010066091 Bronchial Hyperreactivity Diseases 0.000 description 1
- 208000009079 Bronchial Spasm Diseases 0.000 description 1
- 208000014181 Bronchial disease Diseases 0.000 description 1
- 206010006482 Bronchospasm Diseases 0.000 description 1
- 201000006306 Cor pulmonale Diseases 0.000 description 1
- 208000000059 Dyspnea Diseases 0.000 description 1
- 206010013975 Dyspnoeas Diseases 0.000 description 1
- 206010016654 Fibrosis Diseases 0.000 description 1
- 208000007101 Muscle Cramp Diseases 0.000 description 1
- 208000004186 Pulmonary Heart Disease Diseases 0.000 description 1
- 206010057190 Respiratory tract infections Diseases 0.000 description 1
- 208000005392 Spasm Diseases 0.000 description 1
- 206010046306 Upper respiratory tract infection Diseases 0.000 description 1
- 230000001154 acute effect Effects 0.000 description 1
- 208000026935 allergic disease Diseases 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- 239000004411 aluminium Substances 0.000 description 1
- 230000001088 anti-asthma Effects 0.000 description 1
- 230000003064 anti-oxidating effect Effects 0.000 description 1
- 239000000924 antiasthmatic agent Substances 0.000 description 1
- GDTBXPJZTBHREO-UHFFFAOYSA-N bromine Substances BrBr GDTBXPJZTBHREO-UHFFFAOYSA-N 0.000 description 1
- 229910052794 bromium Inorganic materials 0.000 description 1
- 230000036427 bronchial hyperreactivity Effects 0.000 description 1
- 201000011510 cancer Diseases 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000003912 environmental pollution Methods 0.000 description 1
- GKIPXFAANLTWBM-UHFFFAOYSA-N epibromohydrin Chemical compound BrCC1CO1 GKIPXFAANLTWBM-UHFFFAOYSA-N 0.000 description 1
- 210000002388 eustachian tube Anatomy 0.000 description 1
- 239000003172 expectorant agent Substances 0.000 description 1
- 230000004761 fibrosis Effects 0.000 description 1
- 208000019622 heart disease Diseases 0.000 description 1
- 125000004836 hexamethylene group Chemical group [H]C([H])([*:2])C([H])([H])C([H])([H])C([H])([H])C([H])([H])C([H])([H])[*:1] 0.000 description 1
- QWPPOHNGKGFGJK-UHFFFAOYSA-N hypochlorous acid Chemical compound ClO QWPPOHNGKGFGJK-UHFFFAOYSA-N 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 208000015181 infectious disease Diseases 0.000 description 1
- 230000002757 inflammatory effect Effects 0.000 description 1
- 206010022000 influenza Diseases 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 230000007794 irritation Effects 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 229940066491 mucolytics Drugs 0.000 description 1
- 230000006855 networking Effects 0.000 description 1
- 230000000414 obstructive effect Effects 0.000 description 1
- 230000009984 peri-natal effect Effects 0.000 description 1
- 230000002685 pulmonary effect Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 230000000630 rising effect Effects 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 210000000115 thoracic cavity Anatomy 0.000 description 1
- 230000002110 toxicologic effect Effects 0.000 description 1
- 231100000027 toxicology Toxicity 0.000 description 1
- 230000001052 transient effect Effects 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to an aerosol taking salbutamol and ambroxol as active ingredients, which is prepared from salbutamol and ambroxol or salts thereof, or purified hydrates thereof serving as medicinal active ingredients and pharmaceutically acceptable auxiliary materials. The aerosol is prepared by adding some specific types of auxiliary materials in certain proportions and blowing a certain amount of propellent into the salbutamol and ambroxol or the salts thereof, or the purified hydrates thereof serving as raw materials according to the technological measure stated by the invention, and is used for suction.
Description
Technical field
The present invention relates to a kind of is the aerosol of active component with albuterol and ambroxol or its salt or its purified hydrate.Belong to medical technical field.
Background technology
Respiratory system disease is the commonly encountered diseases and the frequently-occurring disease of harm people ' s health, and its sickness rate all accounts for first of the multiple disease at any age group.Data show according to U.S.'s statistics yearbook, in all causes of the death are sorted out, with the cause of the death ranking of diseases concerned with respiratory (not comprising tumor) the 10th the 4th (chronic obstructive pulmonary disease) and the 8th (pneumonia, influenza and upper respiratory tract infection) that rises to 1991 from 1970.Britain thoracic surgery association points out that respiratory system disease has replaced cancer and heart disease in a research report of delivering recently, become the highest disease of Britain's mortality rate.This report says that in Britain, respiratory system diseases such as pneumonia and pulmonary carcinoma cause 150,000 people's death every year, account for 1/4th of all death tolls of Britain, and this numeral is the twice of European respiratory system disease death toll.And in China, because densely populated, factors such as the more and environmental pollution of smoking population, the sickness rate of respiratory system disease and mortality rate are all high in recent years.According to China coroner's inquest result in 1992, the mortality rate of respiratory system disease (not comprising pulmonary carcinoma) in the city accounts for the 3rd, then accounts for the first place in the rural area.What more should pay attention to is because atmospheric pollution, smoking, aged tendency of population and other factors, be chronic obstructive pulmonary disease both domestic and external (abbreviation chronic obstructive pulmonary disease), comprise that sickness rate, the mortality rate of diseases such as chronic bronchitis, emphysema, pulmonary heart disease, bronchial asthma, pulmonary carcinoma, pulmonary's dispersivity homogeneity fibrosis and pneumonopathy infection is growing on and on.
Along with the raising of people's living standard, China is also the same to other developed countries, and the sickness rate of this class disease is in continuous rising.Chinese Pharmaceutical Association whole nation medication economics Information Network shows that to the investigation to 20031 seasons networking hospital respiratory medicine in 2000 respiratory medicine is purchased the medicine amount of money and kept lasting growth, and 2002 than growth by 25% in 2000; And the first quarter in 2003 than increasing by 3.3% the first quarter last one year (fourth quater in 2002), then increased by 30.7% than 2000 year first quarter.Therefore, the medicine of this type of disease of research and development treatment must hold out broad prospects.
Ambroxol hydrochloride claims ammonia bromohydrin, bromine hexamethylene ammonia alcohol again.It is mucolytic agent.Respiratory system there is the effect of comprising.Studies confirm that according to modern pharmacology: ambroxol hydrochloride has tangible antioxidation, remove oxide H-, HOCl, weaken bronchial hyperreactivity, the secretion of irritation cell surfactant, reduce the release of inflammatory mediator, promote the effect such as synthetic of alveolar and pharyngotympanic tube surface mass.Be mainly used in prepayment and treatment transient respiratory distress of the newborn card, lung proteinosis card, acute respiratory distress card, perinatal stage pneumonopathy complication clinically and breathe allergic disease etc.
Pharmacokinetic proves it, and metabolism is rapid in vivo, drains comparatively fast, and the oral formulations bioavailability is low.The toxicologic study surface, the ambroxol hydrochloride side effect seldom, and is safe in utilization.
Beta 2-receptor on can the selectivity exciting bronchial smooth muscle of salbutamol sulfate makes bronchial smooth muscle lax, thereby removes bronchial muscular spasm.Stronger to bronchiectatic activity, and a little less than the β1-Shou Ti effect to heart, be safer at present, the most frequently used anti-asthmatic, be applicable to and prevent and treat bronchial asthma, the bronchospasm of asthmatic bronchitis and emphysematic patients is alleviated the symptoms such as dyspnea that cause because of airway obstructive diseases such as bronchial asthma, chronic bronchitis and emphysema.
Summary of the invention
Having the purpose of this invention is to provide a kind of is the aerosol of active component with albuterol and ambroxol or its salt or its hydrate.It is characterized in that it is to be active component with albuterol and ambroxol or its salt or its hydrate, with acceptable accessories and quantitatively charge into can be for the formed aerosol formulations of propellant that sucks.
Above-mentioned a kind of aerosol, albuterol is preferably sulfate, and ambroxol is preferably hydrochlorate.
Above-mentioned a kind of aerosol, its prescription is composed as follows
Salbutamol sulfate is 0.2-0.8 part
Ambroxol hydrochloride is 5-15 part
Dehydrated alcohol is 10-30 part
Surfactant is 0.5-3 part
Propellant is 60-90 part
Also can add an amount of stabilizing agent, correctives as requested.
Above-mentioned a kind of aerosol, it is characterized in that described pharmaceutically acceptable pharmaceutic adjuvant comprise stabilizing agent, correctives, suspending agent, surfactant, can be in the propellant that sucks one or more.
Above-mentioned a kind of aerosol is characterized in that, described suspending agent can be in methylcellulose, hypromellose, PVP, the Polyethylene Glycol one or more.Be preferably PVP and Polyethylene Glycol.
Above-mentioned a kind of aerosol is characterized in that, described stabilizing agent comprises but is not limited only to tween 80, propylene glycol and glycerol.
Above-mentioned a kind of aerosol is characterized in that, described surfactant comprises but is not limited only to a kind of in tween 80, tween 1, Tween-40, tween 20, Arlacel-80, Arlacel-40, Arlacel-20, oleic acid or the phospholipid or their compositions.
Above-mentioned a kind of aerosol is characterized in that, described propellant comprises but is not limited only to tetrafluoroethane, heptafluoro-propane, n-propane, normal butane, iso-butane.Be preferably tetrafluoroethane and heptafluoro-propane.
Above-mentioned a kind of aerosol, it is characterized in that, described aerosol preparation technology is as follows: get ethanol, add stabilizing agent, surfactant, add principal agent again and each supplementary material makes dissolving, can add correctives in case of necessity, quantitatively divide to be filled in the specific aerosol bottle, compress proportional valve, and quantitatively charge into propellant, get final product.
Above-mentioned a kind of aerosol is characterized in that, described correctives is fat-soluble correctives, as the Herba Menthae wet goods.
The specific embodiment
Come the present invention done further specifying by following example, comprise but be not restricted to following example.
Embodiment 1: salbutamol sulfate and aerosol of ambroxol hydrochloride
Prescription:
Preparation method:
Get dehydrated alcohol, add propylene glycol and Oleum menthae, add the salbutamol sulfate and the ambroxol hydrochloride of recipe quantity again, stir, quantitatively be sub-packed in the aerosol bottle, compress aerosol valve, quantitatively charge into the propellant tetrafluoroethane, get final product.Whenever press 200 microlitres, promptly whenever press 1 milligram of sulfur acid albuterol, 15 milligrams of ambroxol hydrochlorides.
Embodiment 2: salbutamol sulfate and aerosol of ambroxol hydrochloride
Prescription:
Preparation method:
Get dehydrated alcohol, add tween, add the salbutamol sulfate and the ambroxol hydrochloride of recipe quantity, stir, quantitatively be sub-packed in the aerosol bottle, compress aerosol valve, quantitatively charge into propellant, get final product.Whenever press 200 microlitres, promptly whenever press 1 milligram of sulfur acid albuterol, 15 milligrams of ambroxol hydrochlorides.
Embodiment 3: salbutamol sulfate and aerosol of ambroxol hydrochloride
Prescription:
Preparation method:
Get the ethanol of recipe quantity, add PVP and make dissolving, add the glycerol stirring and dissolving, add the albuterol and the ambroxol of recipe quantity, stir, quantitatively be sub-packed in the aerosol aluminium pot, compress the aerosol quantitative valve, quantitatively charge into tetrafluoroethane, get final product.Whenever press 200 microlitres, promptly whenever press 1 milligram of sulfur acid albuterol, 15 milligrams of ambroxol hydrochlorides.
Claims (9)
1. one kind is the aerosol of active component with albuterol and ambroxol, it is characterized in that containing active component albuterol and ambroxol or its salt or its purified hydrate and pharmaceutically acceptable pharmaceutic adjuvant and make solution or suspension, and put into that specific aerosol bottle charges into that specific propellant makes for inhalant novel formulation.
2. aerosol according to claim 1 is characterized in that albuterol is preferably sulfate, and ambroxol is preferably hydrochlorate.
3. according to the described aerosol of claim 2, it is characterized in that described pharmaceutically acceptable pharmaceutic adjuvant comprise stabilizing agent, correctives, suspending agent, surfactant, can be in the propellant that sucks one or more.
4. according to the described aerosol of claim 3, it is characterized in that each component ratio is as follows in the prescription:
Salbutamol sulfate is 0.2-0.8 part
Ambroxol hydrochloride is 5-15 part
Dehydrated alcohol is 10-30 part
Surfactant is 0.5-3 part
Propellant is 60-90 part
Also can add an amount of stabilizing agent, correctives as requested.
5. preparation according to claim 4 is characterized in that, described suspending agent can be in methylcellulose, hypromellose, PVP, the Polyethylene Glycol one or more.
6. preparation according to claim 4 is characterized in that, described stabilizing agent comprises but is not limited only to tween 80, propylene glycol and glycerol.
7. preparation according to claim 4, it is characterized in that described surfactant comprises but is not limited only to a kind of in tween 80, Tween-60, Tween-40, tween 20, Arlacel-80, Arlacel-40, Arlacel-20, oleic acid or the phospholipid or their compositions.
8. preparation according to claim 4 is characterized in that, described propellant comprises but is not limited only to tetrafluoroethane, heptafluoro-propane, n-propane, normal butane, iso-butane.Be preferably tetrafluoroethane and heptafluoro-propane.
9. aerosol according to claim 4, it is characterized in that, described aerosol preparation technology is as follows: get ethanol, add stabilizing agent, surfactant, can add an amount of correctives in case of necessity, add principal agent and each supplementary material and make dissolving, quantitatively divide to be filled in the specific aerosol bottle, compress aerosol valve, and quantitatively charge into propellant, get final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910078514A CN101810603A (en) | 2009-02-25 | 2009-02-25 | Aerosol taking salbutamol and ambroxol as active ingredients |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910078514A CN101810603A (en) | 2009-02-25 | 2009-02-25 | Aerosol taking salbutamol and ambroxol as active ingredients |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101810603A true CN101810603A (en) | 2010-08-25 |
Family
ID=42618065
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200910078514A Pending CN101810603A (en) | 2009-02-25 | 2009-02-25 | Aerosol taking salbutamol and ambroxol as active ingredients |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101810603A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102258504A (en) * | 2011-01-11 | 2011-11-30 | 北京润德康医药技术有限公司 | Compound salbutamol sulfate and ambroxol hydrochloride inhalation solution |
| CN105362226A (en) * | 2015-12-08 | 2016-03-02 | 青岛正大海尔制药有限公司 | Preparation method of ambroxol salbutamol aerosol |
| CN105456240A (en) * | 2015-12-08 | 2016-04-06 | 青岛正大海尔制药有限公司 | Ambroxol and salbutamol aerosol |
-
2009
- 2009-02-25 CN CN200910078514A patent/CN101810603A/en active Pending
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102258504A (en) * | 2011-01-11 | 2011-11-30 | 北京润德康医药技术有限公司 | Compound salbutamol sulfate and ambroxol hydrochloride inhalation solution |
| CN105362226A (en) * | 2015-12-08 | 2016-03-02 | 青岛正大海尔制药有限公司 | Preparation method of ambroxol salbutamol aerosol |
| CN105456240A (en) * | 2015-12-08 | 2016-04-06 | 青岛正大海尔制药有限公司 | Ambroxol and salbutamol aerosol |
| CN105456240B (en) * | 2015-12-08 | 2019-06-25 | 正大制药（青岛）有限公司 | Ambroxol albuterol aerosol |
| CN105362226B (en) * | 2015-12-08 | 2019-06-25 | 正大制药（青岛）有限公司 | The preparation method of ambroxol albuterol aerosol |
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Application publication date: 20100825 |