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CN105456240B - Ambroxol albuterol aerosol - Google Patents

Ambroxol albuterol aerosol Download PDF

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Publication number
CN105456240B
CN105456240B CN201510901472.9A CN201510901472A CN105456240B CN 105456240 B CN105456240 B CN 105456240B CN 201510901472 A CN201510901472 A CN 201510901472A CN 105456240 B CN105456240 B CN 105456240B
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Prior art keywords
ambroxol
aerosol
ambroxol hydrochloride
pvp
ethyl alcohol
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CN105456240A (en
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王明刚
任莉
陈阳生
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Qingdao Guoxin Pharmaceutical Co ltd
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CP Pharmaceutical Qingdao Co Ltd
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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
    • 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
    • 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
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • 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
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • 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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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dispersion Chemistry (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The present invention relates to a kind of ambroxol albuterol aerosols and preparation method thereof, belong to field of pharmaceutical preparations.Aerosol of the invention includes ambroxol hydrochloride, salbutamol sulfate, ethyl alcohol, propylene glycol, dodecyl sodium sulfate, PVP, vitamin C, methyl p-hydroxybenzoate, flavoring apple essence, the components such as F12, quality are stablized, and significant effect can effectively treat the respiratory diseases such as acute/chronic bronchitis and asthma.

Description

Ambroxol albuterol aerosol
Technical field
The present invention relates to field of pharmaceutical preparations, and in particular to a kind of ambroxol albuterol aerosol and preparation method thereof.
Background technique
Respiratory disease is a kind of common disease, frequently-occurring disease, and major lesions are in trachea-bronchial epithelial cell, lung and thoracic cavity, lesion Less serious case's mostly cough, pectoralgia, breathing is impacted, severe one has difficulty in breathing, anoxic or even respiratory failure and it is lethal.Death in city Rate accounts for the 3rd, and in rural area then account for the first.Should more pay attention to, due to atmosphere pollution, smoking, aging of population and other because Element makes chronic obstructive pulmonary disease both domestic and external (abbreviation chronic obstructive pulmonary disease, including chronic bronchitis, pulmonary emphysema, pulmonary heart disease), bronchus The disease incidence of the diseases such as asthma, lung cancer, lung's dispersivity interstitial fibrosis and pulmonary infection, the death rate are growing on and on.
According to national urbans in 2006 and the statistical number of the rural area top ten principal disease cause of death, respiratory system disease Sick (not including lung cancer) accounts for the 4th (13.1%) in the Death causes in city, accounts for third position (16.4%) in rural area.Due to Physical and chemical factor caused by atmosphere pollution, smoking, Industrial Economic Development, biotic factor inhale the factors such as people and population ages aging, Obviously increase the disease incidence of respiratory disease such as lung cancer, bronchial asthma in recent years, Chronic Obstructive Pulmonary Disease occupies height not Under (more than 8% in 40 years old or more crowd).Though pulmonary tuberculosis rate is controlled, has again in recent years and increase trend.Lung thrombus bolt Plug disease has constituted important health care problem, and pulmonary hypertension is also of increasing concern in recent years.Between pulmonary Diffuse The disease incidences such as matter fibrosis and immunocompromised pulmonary infection are increasing.The major causes of death of AIDS is lung's sense Dye, especially pneumocystis carinii pneumonia.Since the end of the year 2002, the infectiousness atypia lung that is broken out in China and world wide Scorching (serious acute respiratory syndrome, SARS) epidemic situation, due to mostly occurring in the young and the middle aged, infectiousness is strong, and case fatality rate is high, and lacks Targetedly drug, thus the fear of the masses is caused, while bringing about great losses to national economy.Go out at present in multiple countries Existing human avian influenza case fatality rate is more than 60%.And it is also lung that avian influenza virus, which invades main target organ in human body,.This positive explanation is exhaled Desorption system disease is still very big, prevention and treatment arduous task to health of our people harm.
Ambroxol hydrochloride (Ambroxol Hydrochloride) is also known as ambroxol hydrochloride, the entitled trans- -4- of chemistry [(2- amino 3,5- dibromo-benzyl) amino] cyclohexanol hydrochloridumi, it be expectorant bromhexine active metabolite (N- demethyl, Cyclohexyl contraposition introduces trans- hydroxyl), toxicity is lower than bromhexine, and activity is higher than bromhexine.Ambroxol hydrochloride is by German vigorous Lin Geyinge writing brush company research and development mucolytic, the medicine in early 1980s first Germany list, then France, The listing in succession of many countries such as Italy, Japan, Spain, is the glutinous phlegm lytic agent of a new generation, can improve expectoration, and have and promote Into pulmonary surfactant and Airway secretion and the effect of ciliary movement.Ambroxol hydrochloride clinically adjustable mucus and glutinous Slurry secretion, activates fibre swing, is easy to dilute sputum, strengthens mucus and transports outward, is easy to be discharged, it can also promote lung surface Active material synthesis guarantees lung functions index to maintain alveolar tension；Promote antibiotic to tissue infiltration, to improve concentration, Enhance bactericidal effect；It is anti-oxidant, inflammatory mediator release is reduced, to mitigate inflammatory reaction；It is cooperateed with bronchus spasmolysis substance, to mention The curative effect of high spasmolysis drug.Therefore, which clinically can be widely applied to breathe with the acute and chronic of respiratory tract abnormal secretion The eliminating the phlegm of road illness, especially chronic bronchitis is treated, the adjuvant treatment of transient respiratory distress of the newborn disease and pulmonary surgery, tool It is toxic it is low, it is curative for effect and can with antibiotic and with generate good synergy the advantages that, be most common expectorant it One.In recent years in the emphasis hospital administration ranking of China main cities, it ranks forefront always.Existing dosage form have oral solution, tablet, Capsule, pellet etc..
Salbutamol sulfate (Salbutamol Sulfate) also known as albuterol, main component are salbutamols, chemistry Entitled 1- (4- hydroxyl -3- hydroxymethyl phenyl) -2- (tert-butylamine base) ethyl alcohol is a kind of highly selective exciting bronchial smooth muscle β-adrenoreceptor excitant, make bronchial smooth muscle relaxation, to release bronchial muscular spasm.To bronchiectasis Effect is stronger, and weaker to the effect of the β1-receptor of heart, is current safer, most common antiasthmatic.Suitable for preventing and treating branch gas The bronchial spasm of pipe asthma, asthmatic bronchitis and emphysematic patients, alleviate because bronchial asthma, chronic bronchitis and The symptoms such as expiratory dyspnea caused by the airway obstructive diseases such as pulmonary emphysema, its advantage is that it is rapid-action, patient symptom can be improved rapidly, Spasmolysis is relievingd asthma, eliminating the phlegm, the disadvantage is that effect is not lasting, functions only as the effect for alleviating patient's asthma symptoms；Long period application can Cause beta-receptor to adjust downwards, patient is made to occur losing beta receptor agonist quick or even invalid to treating asthma drug resistance phenomenon. Present existing dosage form has tablet, controlled release tablet, aerosol etc..
Although having existed the aerosol containing ambroxol hydrochloride and salbutamol sulfate in the prior art, still deposit Poor in stability, quality is difficult to control, the problems such as effect is unstable.
Summary of the invention
The purpose of the present invention is to provide one kind safely and effectively, and quality is stablized, and patient adaptability is strong, significant effect, can have The ambroxol albuterol aerosol of the effect treatment respiratory diseases such as acute/chronic bronchitis and asthma.
The technical solution that the present invention solves the technical problem is:
A kind of ambroxol albuterol aerosol, is prepared from the following components: ambroxol hydrochloride 50-80g, sulfuric acid sand fourth Amine alcohol 50-80g, ethyl alcohol 100-200g, propylene glycol 100-200g, dodecyl sodium sulfate 10-20g, PVP 10-20g, vitamin C 5-10g, methyl p-hydroxybenzoate 0.5-1g, flavoring apple essence 1-2g, appropriate F12, Purified Water q. s.
Preferably, it is prepared from the following components: ambroxol hydrochloride 60g, salbutamol sulfate 60g, ethyl alcohol 150g, the third two Alcohol 150g, dodecyl sodium sulfate 15g, PVP 15g, vitamin C 8g, methyl p-hydroxybenzoate 0.5g, flavoring apple essence 1g, Appropriate F12, Purified Water q. s.
The ambroxol albuterol aerosol the preparation method comprises the following steps: ambroxol hydrochloride and salbutamol sulfate crushed 200 meshes, be added purified water in stirring and dissolving it is uniform, be subsequently added into ethyl alcohol, propylene glycol, dodecyl sodium sulfate, PVP, dimension life Flavoring apple essence is added in plain C and methyl p-hydroxybenzoate, homogeneous stir about 30min under high-shear homogenizing machine, continues stir about 20min, filling bundle valve fill propellant F12, leak detection weighing, install mobility aid to get.
The beneficial effects of the invention are as follows the ambroxol albuterol aerosol quality to stablize, and significant effect can be controlled effectively Treat the respiratory diseases such as acute/chronic bronchitis and asthma.
Specific embodiment
Present invention will be further explained below with reference to specific examples.It should be understood that these embodiments are merely to illustrate the present invention Rather than it limits the scope of the invention.In the following examples, the experimental methods for specific conditions are not specified, usually according to conventional strip Part or according to the normal condition proposed by manufacturer.Unless otherwise stated, otherwise all percentage, ratio, ratio or number is pressed Poidometer.
Unless otherwise defined, it anticipates known to all professional and scientific terms as used herein and one skilled in the art Justice is identical.In addition, any method similar to or equal to what is recorded and material can be applied to the method for the present invention.Wen Zhong The preferred implement methods and materials are for illustrative purposes only.
Embodiment 1
Each component is weighed by following weight proportion: ambroxol hydrochloride 50g, salbutamol sulfate 50g, ethyl alcohol 100g, the third two Alcohol 100g, dodecyl sodium sulfate 10g, PVP 10g, vitamin C 5g, methyl p-hydroxybenzoate 0.5g, flavoring apple essence 1g, Ambroxol hydrochloride and salbutamol sulfate crushed 200 meshes, stir in addition purified water molten by appropriate F12, Purified Water q. s Solution uniformly, is subsequently added into ethyl alcohol, propylene glycol, dodecyl sodium sulfate, PVP, vitamin C and methyl p-hydroxybenzoate, height is cut Homogeneous stir about 30min under homogenizer to be cut, flavoring apple essence is added, continues stir about 20min, filling bundle valve fills propellant F12, Leak detection weighing, install mobility aid to get.
Embodiment 2
Each component is weighed by following weight proportion: ambroxol hydrochloride 60g, salbutamol sulfate 60g, ethyl alcohol 150g, the third two Alcohol 150g, dodecyl sodium sulfate 15g, PVP 15g, vitamin C 8g, methyl p-hydroxybenzoate 0.5g, flavoring apple essence 1g, Ambroxol hydrochloride and salbutamol sulfate crushed 200 meshes, stir in addition purified water molten by appropriate F12, Purified Water q. s Solution uniformly, is subsequently added into ethyl alcohol, propylene glycol, dodecyl sodium sulfate, PVP, vitamin C and methyl p-hydroxybenzoate, height is cut Homogeneous stir about 30min under homogenizer to be cut, flavoring apple essence is added, continues stir about 20min, filling bundle valve fills propellant F12, Leak detection weighing, install mobility aid to get.
Embodiment 3
Each component is weighed by following weight proportion: ambroxol hydrochloride 80g, salbutamol sulfate 80g, ethyl alcohol 200g, the third two Alcohol 200g, dodecyl sodium sulfate 20g, PVP 20g, vitamin C 10g, methyl p-hydroxybenzoate 1g, flavoring apple essence 2g, Ambroxol hydrochloride and salbutamol sulfate crushed 200 meshes, stir in addition purified water molten by appropriate F12, Purified Water q. s Solution uniformly, is subsequently added into ethyl alcohol, propylene glycol, dodecyl sodium sulfate, PVP, vitamin C and methyl p-hydroxybenzoate, height is cut Homogeneous stir about 30min under homogenizer to be cut, flavoring apple essence is added, continues stir about 20min, filling bundle valve fills propellant F12, Leak detection weighing, install mobility aid to get.
Embodiment 4: stability test
1. influence factor is tested
2 gained ambroxol albuterol aerosol of embodiment is respectively placed in low temperature (4 DEG C), Qiang Guang by commercially available back It 10 days under the conditions of (4500lx), high temperature (60 DEG C) and high humidity (RH75%), was sampled respectively at the 0th, 5,10 day, main ingredient is often pressed in detection Every quality index such as content, drug content, related substance, the results are shown in Table 1.
1 ambroxol albuterol aerosol influence factor test result of table
The result shows that: ambroxol albuterol aerosol press by commercially available back respectively high temperature (60 DEG C), low temperature (4 DEG C), It is placed 10 days under the conditions of Qiang Guang (4500lx), high humidity (RH75%), detects every quality index, compared with 0 day, remove high temperature (60 DEG C) related substance is increased slightly and the content of ambroxol hydrochloride and salbutamol sulfate is declined outer, other every quality Index has no significant change.
2. accelerated test
2 gained ambroxol albuterol aerosol of embodiment is placed in 40 DEG C, the constant temperature of RH20%, constant humidity by commercially available back It 6 months in case, was sampled respectively at the 0th, 1,2,3,6 month, the items such as drug content, drug content, related substance are often pressed in measurement Quality index the results are shown in Table 2.
2 ambroxol albuterol aerosol accelerated test result of table
The result shows that: ambroxol albuterol aerosol places 6 by commercially available back under conditions of 40 DEG C, RH20% Month, compared with 0 month, in addition to related substance is increased slightly, other every quality index have no significant change, and quality stabilization can It leans on, meets regulation.
3. long term test
2 gained ambroxol albuterol aerosol of embodiment is placed in 25 DEG C, in the environment of RH60% by commercially available back, point It was not sampled in the 0th, 3,6,9,12,18,24 month, inspection is often pressed every quality such as drug content, drug content, related substance and referred to Mark, the results are shown in Table 3.
3 ambroxol albuterol aerosol long-term test results of table
The result shows that: ambroxol albuterol aerosol is placed 36 months in 25 DEG C, RH60% environment by commercially available back, Indices have no significant change compared with 0 month, and quality is reliable and stable, meet regulation.
The phenol red secretory volume pharmacological testing of 5 mouse tracheae of embodiment
To mouse peritoneal injection indicator it is phenol red after, the latter can partly from tracheae secrete be discharged.Ambroxol hydrochloride and Salbutamol sulfate can enhance the secreting function of respiratory tract, to increase accordingly phenol red excretion amount.It is filled through sodium bicarbonate solution After scrubber tube, irrigating solution is made to develop the color, detects OD value with spectrophotometer, phenol red excretion amount is checked in, so as to examine drug Phlegm-dispelling functions.
Experimental method: 60 mouse are taken to be randomly divided into 6 groups, respectively blank control group, ambroxol hydrochloride group, sulfuric acid sand fourth Amine alcohol group, embodiment 2 are not filled by basic, normal, high three dosage groups of composition of propellant, weighing, label, dosage such as table 4 Shown, blank control group gives physiological saline, and administration mode is stomach-filling.After 30min, phenol red solution is injected intraperitoneally respectively After 0.1mL/10g, 30min, animal is put to death, polish No. 7 syringe needles are inserted into tracheaes about under larynx by anatomical isolation tracheae 0.3cm after being fixed with silk thread ligation, extracts sodium bicarbonate solution 0.5mL with 1mL syringe, and passing through syringe needle, lavation breathes back and forth Road 3 times, last 1 time by irrigating solution extract out injecting tube in, aforesaid operations continuous 3 times, altogether rinse 9 times, be pumped irrigating solution about 1.2-1.5mL is placed in test tube, centrifugation, with 721 type spectrophotometers, wavelength 546nm, reads trap OD value.In standard song Corresponding phenol red concentration is checked on line, compares the difference of each group tracheae section phenols contents.The results are shown in Table 4.
The phenol red secretory volume test result of 4 mouse tracheae of table
Group Dosage (mg/kg) Phenol red amount (μ g/mL) Incrementss (%)
Blank control 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
Composition low dose group 20 0.84±0.41 44.83
Composition middle dose group 40 0.99±0.27 70.69
Composition high dose group 60 1.24±0.32 113.81
Experimental result: the result shows that each administration group can obviously increase the phenol red secretory volume of Respiratory Tract of Mice, wherein this hair Basic, normal, high three dosage groups of bright composition act on enhancing compared with ambroxol hydrochloride group or salbutamol sulfate group is applied alone, poor It is not significant, and function and effect are related with the dosage of each composition, effect of high dosage is best.
The foregoing is merely illustrative of the preferred embodiments of the present invention, the substantial technological content model being not intended to limit the invention It encloses, substantial technological content of the invention is broadly defined in the scope of the claims of application, any technology that other people complete Entity or method also or a kind of equivalent change, will if identical with defined in the scope of the claims of application It is considered as being covered by among the scope of the claims.

Claims (1)

1. a kind of ambroxol albuterol aerosol, which is characterized in that be prepared from the following components: ambroxol hydrochloride 60g, sulphur Sour salbutamol 60g, ethyl alcohol 150g, propylene glycol 150g, dodecyl sodium sulfate 15g, PVP 15g, vitamin C 8g, to hydroxyl Methyl benzoate 0.5g, flavoring apple essence 1g, appropriate F12, Purified Water q. s.
CN201510901472.9A 2015-12-08 2015-12-08 Ambroxol albuterol aerosol Active CN105456240B (en)

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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)

* Cited by examiner, † Cited by third party
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
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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