CN101897720A - Medicinal composition for treating respiratory disease - Google Patents
Medicinal composition for treating respiratory disease Download PDFInfo
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- CN101897720A CN101897720A CN2010102376641A CN201010237664A CN101897720A CN 101897720 A CN101897720 A CN 101897720A CN 2010102376641 A CN2010102376641 A CN 2010102376641A CN 201010237664 A CN201010237664 A CN 201010237664A CN 101897720 A CN101897720 A CN 101897720A
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- respiratory tract
- ambroxol hydrochloride
- alevaire
- treatment
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Abstract
The invention relates to a medicinal composition for treating respiratory disease, in particular to a medicinal composition with synergy for sucking administration of ambroxol hydrochloride and tetrabutyl phenolic aldehyde. A medicament is administrated by sucking and directly enters an air passage, so the suction rate is high, the local has high concentration, low using amount and low adverse reaction, and the medicament can effectively promote the discharge of sputum of a patient and remarkably improve the application compliance of the patient.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of respiratory tract disease, particularly a kind of have the ambroxol hydrochloride of synergistic function and a pharmaceutical composition of alevaire inhalation route administration.
Background technology
Respiratory system disease diagnosis with " cough, expectorant, breathe heavily, inflammation " four big symptoms serve as mainly to show.Cough is a kind of protectiveness physiological reflection, can promote sputum to discharge, it also is a kind of pathological reaction simultaneously, can be stimulated by rheuminess thing such as sputum and foreign body to cause, over-drastic cough vibration also can damage lung tissue, also is the main method of cough-relieving so get rid of sputum; Breathe heavily and many cause by the bronchitis spasm, but and bronchospasm reflexive ground causes that respiratory secretions is that sputum increases, too much secretions stops up and also can further increase the weight of bronchospasm; The pathological manifestations of inflammation be go bad, ooze out, hypertrophy, acute inflammation is to ooze out, chronic inflammatory disease is based on hypertrophy, and the chronic inflammatory disease acute attack is also to ooze out, and the inflammatory exudate of particularly pharynx of respiratory system, larynx, trachea, bronchus, lung tissue is sputum.In sum, " cough, expectorant, breathe heavily, inflammation " four big symptoms are the center with expectorant, eliminating the phlegm is the key point of treatment respiratory tract disease.
Ambroxol (Ambroxol) is an ambroxol hydrochloride, claims the hydrochloric acid NA-872 again, is the glutinous expectorant lytic agent of a new generation.Ambroxol by regulating the respiratory tract secretory cell mucus and the secretion of serosity material, make the polysaccharide fiber of the acidoglycoprotein in serous secretion increase, the cracking sputum and suppress in mucous gland and the goblet cell acidic protein synthetic, and dissolving and dilution thick sputum; Can increase the motion frequency and the intensity of respiratory tract cilium, reduce of the adhesion of sticking expectorant, sputum is discharged from easily, keep airway patency respiratory tract wall; Can increase the generation and the secretion of pulmonary surfactant, thereby reduce airway resistance, reduce mucous adhesive force, activate and promotion mucociliary function.Ambroxol is except that powerful dissolving thick sputum effect, and maximum characteristics are to stimulate the synthetic and secretion alveolar surfactant (PS) of alveolar type II cells, and strengthen mucus transport and promote expectoration; PS can the covering protection airway epithelial cell, makes antibacterial can not directly touch the respiratory tract surface, reduces the danger that infects, and also can promote the phagocytosis of macrophage to antibacterial.Also have antioxidation in addition, suppress all multiactions such as inflammatory mediator release (as histamine, leukotriene, IL-4, TNF-α, IL-2 and interferon etc.), lax airway smooth muscle.Ambroxol is to act on the strongest expectorant at present clinically, is applicable to the thick sputum that acute and chronic respiratory tract disease (as acute and chronic bronchitis, bronchial asthma, bronchiectasis, pulmonary tuberculosis etc.) causes, dys-expectoration.Extensive use at home and abroad in recent years, very sure to its curative effect, and almost non-toxic side effect.
Alevaire has another name called tyloxapol (Tyloxapol), is surfactant, by reducing absorption affinity between sticking expectorant surface tension and airway epithelia, makes expectorant be easy to expectoration, thereby reaches expectorant effect.In preparation, also brought into play the effect such as emulsifying, anatonosis of auxiliary agent.Be applicable to the thick disease that is difficult for expectoration of expectorant clinically,, also be applicable to dys-expectoration person behind the surgical operation as eliminating the phlegm of chronic bronchitis, bronchial asthma, emphysema, bronchiectasis, pulmonary abscess, pneumosilicosis, pertussis etc.
Ambroxol hydrochloride and alevaire have synergistic function.Ambroxol hydrochloride can promote the synthetic and secretion of alveolar surfactant, and can dissolve the mucopolysaccharide and the mucoprotein fiber of the glutinous apoplexy due to phlegm of respiratory tract, promotes sputum to discharge, and makes respiratory passage unblocked.Alevaire itself is exactly a kind of surfactant, can reduce the surface tension of sputum and sputum is reduced, and makes expectorant be easy to expectoration.The mechanism of action difference of the two, alevaire can assist ambroxol hydrochloride to strengthen phlegm-dispelling functions, it is better that the two share expectorant effect, be applicable to acute, the chronic respiratory tract disease, particularly chronic bronchitis acute exacerbation and asthmatic bronchitis of and expectoration dysfunction undesired with the sputum secretion.
Aerosol is meant medicine and the propellant that suits is loaded on clear liquid, suspension or the emulsion of making in the withstand voltage hermetic container with special valve system, borrow the pressure of propellant that content is the preparation that droplet sprays during use, can be at respiratory tract, skin or performance local action of other tracts or general action.The dosage form that ambroxol hydrochloride is commonly used has oral administration solution, tablet, capsule, slow releasing capsule, injection, aerosol etc., and the oral formulations onset is slow, and whole body plays a role, erious adverse reaction, but easy to use.Though injection can directly be imported blood of human body with medicine, onset is very fast relatively, but still whole body plays a role, and erious adverse reaction brings certain painful and inconvenient simultaneously to the patient.Ambroxol hydrochloride and alevaire are prepared into aerosol, and people's administration is inhaled in atomizing can make medicine directly enter air flue, the inhalation rate height, the part has higher concentration, consumption is little, and the therapeutic process patient all can fine tolerance, can reach safety, targeting, quick-acting, therapeutic purposes efficiently.Ambroxol hydrochloride can be dissolved in methanol, and is molten in the water part omitted, and slightly soluble in ethanol, alevaire are a kind of surfactants, can increase the dissolubility of ambroxol hydrochloride, can improve liquid medicine stability, makes uniform and stable preparation.
Wu Xuwei etc. have invented aerosol of ambroxol hydrochloride, be made up of feed liquid, propellant, and feed liquid are made up of ambroxol hydrochloride, cosolvent, surfactant and additive.
Summary of the invention
The purpose of this invention is to provide a kind of ambroxol hydrochloride alevaire aerosol for the treatment of respiratory tract disease, the administration of this product inhalation route, medicine directly enters air flue inhalation rate height, the part has higher concentration, consumption is little, untoward reaction is little, can safely, effectively promote the discharge of patient's sputum, significantly improves the compliance of patient's medication.
Technical scheme provided by the invention is: ambroxol hydrochloride alevaire aerosol, comprise feed liquid, propellant, and feed liquid is made up of hydrochloric acid ammonia ambroxol, alevaire, common solvent, surfactant and additive.
The present invention contains 5-50 part ambroxol hydrochloride, 5-50 part alevaire, 5-80 part propellant, 5-70 part solvent, 0.1-10 part surfactant, 0.1-20 part additive altogether; Above umber is parts by weight.
Described propellant is one or more in dichlorodifluoromethan hydrocarbon, fluorohydrocarbon class, Compressed Gas, the ethers.Be preferably CFC-12, CFC-11, HFC-134a, dimethyl ether (DME), solubility Compressed Gas, alkanes propellant or CFC-12 and CFC-11 mix propellant, dimethyl ether and solubility Compressed Gas mix propellant, propane and iso-butane mixing propellant.Described solubility Compressed Gas is a carbon dioxide, and alkanes propellant and propane are A-31 with iso-butane mixing propellant, A-46.
Described solvent altogether is water, ethanol, glycerol, propylene glycol, Polyethylene Glycol (PEG100-1000), sorbester p37, sorbester p17, sorbester p38, sorbester p18, sorbester p17 and/or Tween 80; Surfactant is selected from polyvidone (PVP), Polyethylene Glycol (PEG), sorbester p37, sorbester p17, sorbester p38, sorbester p18, span 40, span 20, Tween 80, polysorbate40, polysorbas20, the compound of sorbester p37 and sorbester p17, sorbester p38 and sorbester p18, sorbester p17 and Tween 80, oleic acid or fabaceous lecithin; Additive is glycerol, propylene glycol, tween or Oleum menthae transdermal enhancer.
The suspending agent polyethylene that the present invention also can contain 0-5 part weight adjoins pyrrolidone (PVP), Polyethylene Glycol (PEG) or lactose.
Ambroxol hydrochloride alevaire aerosol of the present invention can be decided to be 5-30mg with each dosage of ambroxol hydrochloride according to the consumption of existing preparation, and alevaire be raw material and adjuvant simultaneously, and using dosage is decided to be 5-50mg, every day 3 times at every turn.This product adopts inhalation, absorbs soon, and zest is little, good drug efficacy, bioavailability height.
Ambroxol hydrochloride alevaire aerosol of the present invention, beneficial effect is:
1, alevaire can assist ambroxol hydrochloride to strengthen phlegm-dispelling functions, and it is better that the two share expectorant effect.
2, the aerosol goods are encapsulated in the highly airtight container and can oxidizedly go bad, can be not contaminated or dry, can keep its effect.
3, tight leakproof, anti-overflow.Of many uses, can set foot in many applications.
4, manipulate, carry and convenient storage, do not need by other instruments, not resembling other oral drugs need take medicine by water, can not touch human body and overflows and contaminated environment.
5, prove effective rapidly, accurately quantitatively agent, less wastage.Has unique advantage especially in treatment asthma, the field of eliminating the phlegm.
Specific embodiment the present invention can be illustrated with the following examples
Embodiment 1: 50 gram ambroxol hydrochlorides and 50 gram alevaires are added mix homogeneously in the 560 gram ethanol, add 22 gram tween 80s, 10 gram glycerol and 8 gram PVP (k15) stir and obtain feed liquid.Feed liquid is contained 500 milligrams of ambroxol hydrochloride packing by every bottle, seal, every bottle charges into 2 gram carbon dioxide and 3 gram dimethyl ether (DME), bathes inspection, packing, check.
Embodiment 2: 50 gram ambroxol hydrochlorides and 100 gram alevaires are added mix homogeneously in 550 gram ethanol and the 120 gram propylene glycol, add 10 gram PVP (k30) and 20 gram glycerol, stirring obtains feed liquid.Feed liquid is contained 500 milligrams of ambroxol hydrochloride packing by every bottle, seal, every bottle charges into 4 gram Dichloromonofluoromethanes (CFC-11), bathes inspection, packing, check.
Embodiment 3: 50 gram ambroxol hydrochlorides and 150 gram alevaires added mix homogeneously in 540 gram water and the 100 gram propylene glycol, adds 30 gram tween 80s, and 25 gram Arlacel-80s and 5 gram Oleum menthae, stirring obtains feed liquid.Feed liquid is contained 500 milligrams of ambroxol hydrochloride packing by every bottle, seal, every bottle charges into 3 gram dichlorodifluoromethane (CFC-12), bathes inspection, packing, check.
Embodiment 4: 50 gram ambroxol hydrochlorides and 65 gram alevaires added mix homogeneously in 95 gram Polyethylene Glycol (PEG600) and the 55 gram span, adds 22 gram polysorbate40s, and 10 gram oleic acid and 3 gram lactose, stirring obtains feed liquid.Feed liquid is contained 500 milligrams of ambroxol hydrochloride packing by every bottle, seal, every bottle charges into 2 gram HFC-134a, bathes inspection, packing, check.
Embodiment 5: 50 gram ambroxol hydrochlorides and 80 gram alevaires are added mix homogeneously in 60 gram tween 80s and the 200 gram water, add 30 gram fabaceous lecithins and 25 gram Oleum menthae transdermal enhancers, stirring obtains feed liquid.Feed liquid is contained 500 milligrams of ambroxol hydrochloride packing by every bottle, seal, every bottle charges into 3 gram A46, bathes inspection, packing, check.
Embodiment 6: 50 gram ambroxol hydrochlorides and 120 gram alevaires are added mix homogeneously in 540 gram ethanol and the 100 gram propylene glycol, add 2 gram azones and 8 gram PVP (k90), stirring obtains feed liquid.Feed liquid is contained 500 milligrams of ambroxol hydrochloride packing by every bottle, seal, every bottle charges into 3 gram A-31, bathes inspection, packing, check.
Claims (7)
1. pharmaceutical composition for the treatment of respiratory tract disease is characterized in that: said composition comprises as the ambroxol hydrochloride of active constituents of medicine and alevaire and one or more pharmaceutically useful non-active ingredients of the aerosol that can suck that is applicable to and constitutes.
2. the described a kind of pharmaceutical composition for the treatment of respiratory tract disease of claim 1, it is characterized in that: each dosage of ambroxol hydrochloride is decided to be 5-30mg, and the each using dosage of alevaire is decided to be 5-50mg, every day 3 times.
3. the described a kind of pharmaceutical composition for the treatment of respiratory tract disease of claim 1, it is characterized in that: each dosage of ambroxol hydrochloride is decided to be 5-15mg, and the each using dosage of alevaire is decided to be 5-30mg, every day 3 times.
4. the described a kind of pharmaceutical composition for the treatment of respiratory tract disease of claim 1, it is characterized in that: each dosage of ambroxol hydrochloride is decided to be 5-10mg, and the each using dosage of alevaire is decided to be 5-20mg, every day 3 times.
5. the described a kind of pharmaceutical composition for the treatment of respiratory tract disease of claim 1 is characterized in that: the aerosol of described compositions for sucking.
6. the described a kind of pharmaceutical composition for the treatment of respiratory tract disease of claim 1-5 is characterized in that: non-active ingredient comprises propellant, solvent, surfactant and additive are formed altogether.
7. the described a kind of pharmaceutical composition for the treatment of respiratory tract disease of claim 1-5 is characterized in that: described compositions contains 5-50 part ambroxol hydrochloride, 5-50 part alevaire, 5-80 part propellant, 5-70 part solvent, 0.1-10 part surfactant, 0.1-20 part additive altogether; Above umber is parts by weight.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
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| CN201010237664.1A CN101897720B (en) | 2010-07-27 | 2010-07-27 | A kind of pharmaceutical composition for the treatment of respiratory tract disease |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201010237664.1A CN101897720B (en) | 2010-07-27 | 2010-07-27 | A kind of pharmaceutical composition for the treatment of respiratory tract disease |
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| CN101897720A true CN101897720A (en) | 2010-12-01 |
| CN101897720B CN101897720B (en) | 2015-09-09 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103462942A (en) * | 2013-08-20 | 2013-12-25 | 湖南赛隆药业有限公司 | Suction-type ambroxol hydrochloride solution |
| 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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| CN1695601A (en) * | 2005-05-18 | 2005-11-16 | 湖北南洋药业有限公司 | Aerosol of ambroxol hydrochloride and preparation method |
| CN1838964A (en) * | 2002-04-25 | 2006-09-27 | 斯克里普斯研究学院 | Treatment and prevention of pulmonary conditions |
| CN101214227A (en) * | 2007-12-29 | 2008-07-09 | 沈阳药科大学 | Ambroxol hydrochloride dry powder inhalant and preparation thereof |
| CN101500577A (en) * | 2005-12-20 | 2009-08-05 | 蒂卡莱克梅德尔公司 | Method and system for the delivery of corticosteroids having an enhanced pharmacokinetic profile |
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2010
- 2010-07-27 CN CN201010237664.1A patent/CN101897720B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1838964A (en) * | 2002-04-25 | 2006-09-27 | 斯克里普斯研究学院 | Treatment and prevention of pulmonary conditions |
| CN1695601A (en) * | 2005-05-18 | 2005-11-16 | 湖北南洋药业有限公司 | Aerosol of ambroxol hydrochloride and preparation method |
| CN101500577A (en) * | 2005-12-20 | 2009-08-05 | 蒂卡莱克梅德尔公司 | Method and system for the delivery of corticosteroids having an enhanced pharmacokinetic profile |
| CN101214227A (en) * | 2007-12-29 | 2008-07-09 | 沈阳药科大学 | Ambroxol hydrochloride dry powder inhalant and preparation thereof |
Non-Patent Citations (3)
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| 罗泓: "肺表面活性物质联合盐酸氨溴索治疗新生儿呼吸窘迫综合征的临床观察", 《浙江临床医学》, vol. 13, no. 5, 31 May 2011 (2011-05-31) * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103462942A (en) * | 2013-08-20 | 2013-12-25 | 湖南赛隆药业有限公司 | Suction-type ambroxol hydrochloride solution |
| CN103462942B (en) * | 2013-08-20 | 2016-12-28 | 湖南赛隆药业有限公司 | A kind of suction ambroxol hydrochloride solution |
| 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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| Publication number | Publication date |
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| CN101897720B (en) | 2015-09-09 |
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