CN101810604A - Spray taking salbutamol and ambroxol as active ingredients - Google Patents
Spray taking salbutamol and ambroxol as active ingredients Download PDFInfo
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- CN101810604A CN101810604A CN200910078515A CN200910078515A CN101810604A CN 101810604 A CN101810604 A CN 101810604A CN 200910078515 A CN200910078515 A CN 200910078515A CN 200910078515 A CN200910078515 A CN 200910078515A CN 101810604 A CN101810604 A CN 101810604A
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Abstract
The invention relates to a spray 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 spray is prepared and developed by adding some specific types of auxiliary materials in certain proportions 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.
Description
Technical field
The present invention relates to a kind of is the spray 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 spray 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, the spray agent that forms with acceptable accessories.
Above-mentioned spray is characterized in that, the concentration of salbutamol sulfate is that the concentration of 5mg/ml-20mg/m ambroxol hydrochloride is tax 75mg/ml-250mg/ml.
Above-mentioned spray is characterized in that, described pharmaceutically acceptable pharmaceutic adjuvant comprises one or more in pH regulator agent, antioxidant, correctives, antiseptic, the metal chelating agent.
Above-mentioned spray, it is characterized in that, described pH regulator agent is the water solublity regulator, can be in hydrochloric acid, phosphoric acid, acetic acid, sodium acetate, citric acid, disodium citrate, citric acid trisodium, sodium citrate, citric acid monohydrate, Monopotassium citrate, sodium carbonate, sodium bicarbonate, potassium bicarbonate, sodium hydroxide, potassium hydroxide, phosphate, dihydric phosphate, hydrophosphate, tartaric acid, tartrate, biatrate, aminoacid and the salt thereof one or more.
Above-mentioned spray is characterized in that, described antioxidant can be one or more in sulfurous acid, sulphite, bisulfites, pyrosulfite, thiosulfate, gallic acid and salt cysteine, ascorbic acid and the salt thereof.
Above-mentioned spray, it is characterized in that described correctives includes but are not limited to steviosin, sorbitol, mannitol, maltose alcohol, glycyrrhizin, stem tea element, Sodium Cyclamate, flavoring banana essence, grape essence, cacao essence, flavoring pineapple essence, orange flavor, honey peach essence, apple essence, Herba Menthae essence, strawberry essence, Fructus Foeniculi, vanillin, Fructus Citri Limoniae essence, cherry essence or rose essence.
Above-mentioned spray is characterized in that, described antiseptic comprises but is not limited only to parabens, benzoic acid and salt thereof, sorbic acid and salt thereof, benzalkonium bromide, benzalkonium chloride, chlorhexidine acetate, Oleum Eucalypti, Oleum Cinnamomi, Oleum menthae.
Described a kind of be the spray of active component with albuterol and ambroxol, it is characterized in that described intercalating agent can be one or more in sodium ethylene diamine tetracetate, EDTA calcium complex disodium salt, Ca-EDTA, citric acid and salt thereof, glycine and the salt thereof.
Above-mentioned oral solution, it is characterized in that, described spray preparation technology is as follows: described spray preparation technology is as follows: get partial purification water, add the dissolving of principal agent and adjuvant, regulate pH at last to prescribed limit, add purified water, filter with microporous filter membrane to full dose, divide to be filled in the specific aerosol container, get final product.
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 ambroxol hydrochloride spray agent
Prescription:
Preparation method:
Get purified water 700ml, add ethanol, the salbutamol sulfate and the ambroxol hydrochloride that add recipe quantity again, stirring and dissolving, add aspartame, essence, sodium pyrosulfite and the benzoic acid of recipe quantity, make dissolving, regulating pH value with hydrochloric acid solution and sodium hydroxide solution is 2-4, add purified water to total amount, intermediate detects.After the intermediate detection was qualified, microporous filter membrane filtered, and is sub-packed in the aerosol container, gets final product.Every spray 100 microlitres, promptly every spray contains 1 milligram of albuterol, 15 milligrams of ambroxols.
Embodiment 2: salbutamol sulfate and ambroxol hydrochloride spray agent
Prescription:
Preparation method:
Get purified water 700ml, add propylene glycol, add the salbutamol sulfate and the ambroxol hydrochloride of recipe quantity, stirring and dissolving, get ethanol, add the oxybenzene formic acid and the propyl ester of recipe quantity, make dissolving, add in the medicinal liquid, the sucralose and the essence that add recipe quantity, regulating pH value with citric acid soln and liquor sodii citratis is 2-4, adds purified water to total amount, and intermediate detects.After the intermediate detection was qualified, the microporous filter membrane fine straining was sub-packed in the aerosol container, gets final product.Every spray 100 microlitres, promptly every spray contains 1 milligram of albuterol, 15 milligrams of ambroxols.
Embodiment 3: salbutamol sulfate and ambroxol hydrochloride spray agent
Prescription:
Preparation method:
Get purified water 700ml, get the ethanol of recipe quantity, add propyl hydroxybenzoate and make dissolving, add in the entry, add the vitamin C stirring and dissolving again, the albuterol and the ambroxol that add recipe quantity, stirring and dissolving adds sucralose, essence, make dissolving, regulating pH value with sodium hydroxide solution is 2-4, adds purified water to total amount, and intermediate detects.After the intermediate detection was qualified, the microporous filter membrane fine straining was sub-packed in the aerosol container, gets final product.Every spray 100 microlitres, 1 milligram of promptly every spray sulfur acid albuterol, 15 milligrams of ambroxol hydrochlorides.
Claims (9)
1. one kind is the spray 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, and put into that specific aerosol container makes for inhalant novel formulation.
2. spray according to claim 1 is characterized in that albuterol is preferably sulfate, and ambroxol is preferably hydrochlorate.
3. according to the described spray of claim 2, the concentration of salbutamol sulfate is 5mg/ml-20mg/ml, and the concentration of ambroxol hydrochloride is 75mg/ml-250mg/ml.
4. according to the described spray of claim 2, it is characterized in that described pharmaceutically acceptable pharmaceutic adjuvant comprises one or more in pH regulator agent, antioxidant, stabilizing agent, correctives, the antiseptic.
5. preparation according to claim 4, it is characterized in that, described pH regulator agent is the water solublity regulator, can be in hydrochloric acid, phosphoric acid, acetic acid, sodium acetate, citric acid, disodium citrate, citric acid trisodium, sodium citrate, citric acid monohydrate, Monopotassium citrate, sodium carbonate, sodium bicarbonate, potassium bicarbonate, sodium hydroxide, potassium hydroxide, phosphate, dihydric phosphate, hydrophosphate, tartaric acid, tartrate, biatrate, aminoacid and the salt thereof one or more.
6. preparation according to claim 4 is characterized in that, described antioxidant can be one or more in sulfurous acid, sulphite, bisulfites, pyrosulfite, thiosulfate, gallic acid and salt cysteine, ascorbic acid and the salt thereof.
7. preparation according to claim 4, it is characterized in that described antiseptic comprises but is not limited only to parabens, benzoic acid and salt thereof, sorbic acid and salt thereof, benzalkonium bromide, benzalkonium chloride, chlorhexidine acetate, Oleum Eucalypti, Oleum Cinnamomi, Oleum menthae.
8. preparation according to claim 4 is characterized in that, described stabilizing agent comprises but is not limited only to ethanol, propylene glycol and glycerol.
9. spray according to claim 4, it is characterized in that, described spray preparation technology is as follows: get partial purification water, add principal agent and each supplementary material and make dissolving, regulate pH at last to prescribed limit, add purified water to full dose, microporous filter membrane filters, divide to be filled in the specific aerosol container, get final product.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910078515A CN101810604A (en) | 2009-02-25 | 2009-02-25 | Spray taking salbutamol and ambroxol as active ingredients |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910078515A CN101810604A (en) | 2009-02-25 | 2009-02-25 | Spray taking salbutamol and ambroxol as active ingredients |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101810604A true CN101810604A (en) | 2010-08-25 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200910078515A Pending CN101810604A (en) | 2009-02-25 | 2009-02-25 | Spray taking salbutamol and ambroxol as active ingredients |
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Cited By (4)
| 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 |
| US20140066518A1 (en) * | 2011-03-14 | 2014-03-06 | Boehringer Ingelheim International Gmbh | Use of a sprayable composition comprising ambroxol |
| CN104027326A (en) * | 2013-03-04 | 2014-09-10 | 天津康鸿医药科技发展有限公司 | Ambroxol hydrochloride atomization inhalant, and preparation method and application thereof |
| CN110755413A (en) * | 2019-11-04 | 2020-02-07 | 扬子江药业集团上海海尼药业有限公司 | Ambroxol hydrochloride solution for inhalation and preparation method thereof |
-
2009
- 2009-02-25 CN CN200910078515A patent/CN101810604A/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 |
| US20140066518A1 (en) * | 2011-03-14 | 2014-03-06 | Boehringer Ingelheim International Gmbh | Use of a sprayable composition comprising ambroxol |
| US10959964B2 (en) * | 2011-03-14 | 2021-03-30 | Sanofi-Aventis Deutschland Gmbh | Use of a sprayable composition comprising ambroxol |
| CN104027326A (en) * | 2013-03-04 | 2014-09-10 | 天津康鸿医药科技发展有限公司 | Ambroxol hydrochloride atomization inhalant, and preparation method and application thereof |
| CN110755413A (en) * | 2019-11-04 | 2020-02-07 | 扬子江药业集团上海海尼药业有限公司 | Ambroxol hydrochloride solution for inhalation and preparation method thereof |
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Application publication date: 20100825 |