CN105125542A - Medicine composition with tiotropium bromide and formoterol, application of medicine composition and preparation - Google Patents
Medicine composition with tiotropium bromide and formoterol, application of medicine composition and preparation Download PDFInfo
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- CN105125542A CN105125542A CN201510519826.3A CN201510519826A CN105125542A CN 105125542 A CN105125542 A CN 105125542A CN 201510519826 A CN201510519826 A CN 201510519826A CN 105125542 A CN105125542 A CN 105125542A
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Abstract
The invention relates to the technical field of medicine preparations, in particular to a medicine composition with tiotropium bromide and formoterol, application of the medicine composition and a preparation. The medicine composition comprises the tiotropium bromide or pharmaceutically acceptable salt of the tiotropium bromide and the formoterol or pharmaceutically acceptable salt of the formoterol. The medicine composition with the tiotropium bromide and the formoterol is applied to preparing medicine for treating respiratory and lung inflammatory diseases. The medicine composition is preferably a tiotropium bromide and formoterol composition with synergistic additive effects. The medicine composition, the application and the preparation have the advantages that as proved by pharmacodynamic experiments, the synergistic additive effects can be realized by the tiotropium bromide and the formoterol which are jointly applied, and accordingly bronchiectasis can be forcefully and quickly realized; the medicine composition and the preparation are used for treating the respiratory and lung inflammatory diseases, and preferably used for treating dyspnea such as bronchial asthma and chronic obstructive pulmonary diseases (COPD) due to bronchial constriction.
Description
Technical field
The present invention relates to technical field of medicine, be specifically related to a kind of medical composition and its use and the preparation that contain tiotropium bromide and formoterol.
Technical background
Indication respiratory system disease of the present invention mainly comprises chronic obstructive pulmonary disease (chronicobstructivepulmonarydisease, COPD) and bronchial asthma.
COPD be a kind of with continuous flow be limited as feature can the disease of prevention and therapy, the many development in Progressive symmetric erythrokeratodermia of its flow limitation, the chronic inflammatory reaction to the harmful gass such as tobacco smoke or deleterious particle strengthens relevant with air flue and lung tissue.COPD is a kind of commonly encountered diseases, frequently-occurring disease of serious harm human health, and have a strong impact on the quality of life of patient, case fatality rate is higher, and brings heavy financial burden to patient and family and society thereof.
Chronic obstructive pulmonary disease whole world proposal (globalinitiativeforchronicobstructivelungdisease, GOLD) carries out comprehensive assessment to COPD.In order to better understand the impact of the COPD state of an illness on patient, answer that symptomes complice is assessed, the risk of pulmonary function classification and acute exacerbation, COPD patient is divided into A, B, C, D tetra-groups, refers to table 1, the object of comprehensive assessment improves the disease control of chronic obstructive pulmonary disease.
The comprehensive assessment of table 1.COPD
Bronchial asthma (abbreviation asthma) is a kind of chronic airways disease, and it shows as airway inflammation, and mucilage secretion increases and airway hyperreactivity.Th2 cell, eosinophilic granulocyte, macrophage, neutrophil cell and some other inflammatory factor, chemotactic factor etc. take part in the inflammatory response of allergic asthma jointly.In the past few decades, the incidence rate of whole world asthma, sickness rate and mortality rate increase fast.Although people conduct extensive research for the pathophysiological mechanism of asthma, there is deep understanding, still do not had very effective method to cure this disease at present.
Bronchodilators can relax bronchial smooth muscle, expansion bronchus, alleviation flow limitation, is the primary treatment measure of prevention and corntrol COPD and symptoms of asthma.Main bronchodilators has broxaterol, anticholinergic agent etc., although regularly use short-acting bronchodilator diastole agent price comparatively cheap, easy to use not as durative action preparation.
Summary of the invention
The present invention relates to a kind of long-acting anticholinergic and Long-effect β_2 reactant excitomotor agent pharmaceutical composition and preparation.
A kind of pharmaceutical composition, its active component is grouped into by following two one-tenth: 1) tiotropium bromide or its pharmaceutically acceptable salt, 2) formoterol or its pharmaceutically acceptable salt.
Preferably, the mass ratio of tiotropium bromide and formoterol is: 9 ~ 36:4.5 ~ 18 (μ g/ μ g).
In addition, the invention also discloses the purposes of tiotropium bromide and formoterol pharmaceutical composition.
Tiotropium bromide and formoterol pharmaceutical composition are for the preparation of the application of medicine for the treatment of respiratory tract and pulmonary inflammation disease.
Tiotropium bromide and formoterol pharmaceutical composition are for the preparation of the application of the medicine of the protective effect to bronchoconstriction and airway hyperreactivity.
Tiotropium bromide and formoterol pharmaceutical composition are for the preparation of the application of medicine for the treatment of the respiratory system disease that bronchoconstriction causes.Wherein, described respiratory system disease mainly comprises dyspnea, chronic obstructive pulmonary disease and bronchial asthma.
The invention provides the suction preparation of tiotropium bromide and formoterol pharmaceutical composition, described suction preparation comprises inhalation solution, inhalation aerosol, inhalation powder spray.Said preparation also comprises the pharmaceutic adjuvant that one or more are applicable to pulmonary's inhaled medication.
Preferably, described pharmaceutical composition is micropowder, and the particle diameter of micropowder is 0.2-10 μm.
Preferably, suck preparation and often press containing tiotropium bromide 9 μ g ~ 36 μ g, formoterol 4.5 μ g ~ 18 μ g.
Pharmaceutical composition of the present invention, preferably has tiotropium bromide and the formoterol combination of collaborative summation action.Pharmacodynamics test proves that tiotropium bromide and formoterol use in conjunction have collaborative summation action, can produce bronchiectasis more quickly more by force.Be used for the treatment of respiratory tract pulmonary inflammation disease, the dyspnea that preferred bronchoconstriction causes is as bronchial asthma and chronic obstructive pulmonary disease (COPD).
The invention provides a kind of suction preparation containing tiotropium bromide and formoterol.Prepared medicine has tiotropium bromide and the formoterol of collaborative summation action, the mode administration sucked with pulmonary, the drug excipient also containing preparation permission and carrier.
The different mechanism of action of use in conjunction and the medicine of action time can strengthen bronchorelaxing activity, reduce untoward reaction.Use in conjunction long-acting beta
2excitomotor (LABA) and long-acting m receptor blocking agent (LAMA) can increase the curative effect (especially to the patient of single medicine unsatisfactory curative effect) of patient, further pulmonary function and the health status improving patient, increase compliance, minimizing patient is leaked and is used or multiplex number of times, alleviates patient's financial burden.
Tiotropium bromide is specific selectivity anticholinergic agent, by suppressing smooth muscle M3 receptor, produce bronchiectatic activity, effect maintenance reaches 24 hours, significantly can also improve dyspnea, research proves that tiotropium bromide obviously can improve the guinea pig asthmatic model airway hyperreactivity of histamine induction.Formoterol is Long-acting selective broxaterol, can suppress to suck the early stage of antigen induced and late phase reaction, reduces airway hyperreactivity, has certain antiinflammatory action.Inventor is proved by pharmacodynamic study, in animal model, these two medication combined (LABA/LAMA) has collaborative or additive effect, these two medication combined alone with tiotropium bromide or formoterol is alone compares, and can produce bronchiectatic activity more quickly more by force.On the basis of above related data, inventor has devised the imbedibility compound preparation of a kind of use containing tiotropium bromide and formoterol, be mainly used in treating the respiratory system diseases such as the dyspnea that bronchoconstriction causes.
Detailed description of the invention
In the following example, method therefor if no special instructions, is conventional method.Material required in following examples or reagent, be market if no special instructions and buy.
Embodiment 1
Several anticholinergic and beta 2 receptor agonist compositions bronchiectatic activity compare
1. animal: Cavia porcellus, 40, male and female are regardless of, body weight 300-350g, are purchased from Zhejiang University's Experimental Animal Center, credit number: SCXK (Zhejiang) 2012-0052, animal feeding is in Zhejiang University's Experimental Animal Center.
2. major experimental material: Medlab Biological Signal Collecting System, model MedLab-U/4C501H, Meiyi Science & Technology Co., Ltd., Nanjing; Nebulizer, PARITurboBOY, is produced by German Bry company.
3. animal is divided into 5 groups, often organize 8, be respectively model group, tiotropium bromide (Tio)-0.7 μ g/kg and formoterol (For)-0.35 μ g/kg group, tiotropium bromide (Tio)-0.7 μ g/kg and salmaterol (SMTL)-4 μ g/kg group, ipratropium bromide (IPRA)-9 μ g/kg and formoterol (For)-0.35 μ g/kg group, ipratropium bromide (IPRA)-9 μ g/kg and salmaterol (SMTL)-4 μ g/kg group.
4. Guinea Pig Airway resistance and Cdgn dyanamic compliance measure: 20% urethane anaesthetized guinea pig.Cavia porcellus is placed in health capacity trace case, lies on the back fixing, circulation of qi promoting cannula, insert Cavia porcellus shirtfront 4-5 intercostal, intrathoracic pressure to be measured with the indenting ball of intrathoracic cannula.After breathing is stable, tidal volume, air flue flow velocity, the transpulmonary pressure value of Cavia porcellus before utilizing signal sampler record histamine to suck, based on value.In Guinea Pig Airway, instillation administration, respectively after administration 0.5h, 6h, 12h, allows Cavia porcellus suck each 10s of histamine of 62.5,125,250,500,1000 μ g/ml successively, the change of record Guinea Pig Airway flow velocity, tidal volume and transpulmonary pressure.Calculate the concentration (PC of histamine when lung resistance increases by 100%
100).
5. result: after administration 0.5h, the histamine of Cavia porcellus Neulized inhalation variable concentrations, model group lung resistance obviously increases, the concentration (PC of histamine when each administration group lung resistance increases by 100%
100) significance higher than model group, and has significant difference (p<0.001-0.01), wherein Tio-0.7 μ g/kg and the strongest (PC of For-0.35 μ g/kg group effect
100be 715.31 μ g/ml).After administration 6h, again detect each group of Cavia porcellus PC
100value, result shows, each administration group PC
100value is apparently higher than model group (p<0.001-0.05), when but the bronchiectatic activity of Tio-0.7 μ g/kg and SMTL-4 μ g/kg group, IPRA-9 μ g/kg and For-0.35 μ g/kg group, IPRA-9 μ g/kg and SMTL-4 μ g/kg group is starkly lower than 0.5h after administration, and have significant difference (p<0.05), and almost identical when Tio-0.7 μ g/kg and For-0.35 μ g/kg group effect and administration 0.5h.After administration 12h, each administration group PC
100value is apparently higher than model group (p<0.001,0.05), when but the bronchiectatic activity of Tio-0.7 μ g/kg and SMTL-4 μ g/kg group, IPRA-9 μ g/kg and For-0.35 μ g/kg group, IPRA-9 μ g/kg and SMTL-4 μ g/kg group is starkly lower than 0.5h, 6h after administration, and have significant difference (p<0.01-0.05), and almost identical when Tio-0.7 μ g/kg and For-0.35 μ g/kg group effect and administration 0.5h.This result is pointed out, four kinds of compositionss in this research, and the bronchiectatic activity of tiotropium bromide and formoterol is the strongest, and is also obviously better than other three kinds combinations action time.
Several anticholinergic of table 2. and beta 2 receptor agonist compositions bronchiectatic activity compare
Compare with model group: * p<0.05, * * p<0.01, * * * p<0.001
Compare with after administration 0.5h: #p<0.05, ##p<0.01
Compare with after administration 6h: & p<0.05
Embodiment 2
Tiotropium bromide and formoterol are on the impact of the guinea pig bronchial contractile response that histamine causes
1. animal: Cavia porcellus, 96, male and female are regardless of, body weight 300-350g, are purchased from Zhejiang University's Experimental Animal Center, credit number: SCXK (Zhejiang) 2012-0052, animal feeding is in Zhejiang University's Experimental Animal Center.
2. major experimental material: Medlab Biological Signal Collecting System, model MedLab-U/4C501H, Meiyi Science & Technology Co., Ltd., Nanjing; Nebulizer, PARITurboBOY, is produced by German Bry company.
3. Guinea Pig Airway resistance and Cdgn dyanamic compliance measure: 20% urethane anaesthetized guinea pig.Cavia porcellus is placed in health capacity trace case, lies on the back fixing, circulation of qi promoting cannula, insert Cavia porcellus shirtfront 4-5 intercostal, intrathoracic pressure to be measured with the indenting ball of intrathoracic cannula.After breathing is stable, tidal volume, air flue flow velocity, the transpulmonary pressure value of Cavia porcellus before utilizing signal sampler record histamine to suck, based on value.In Guinea Pig Airway, the corresponding medicine of instillation, after 0.5 hour, allows Cavia porcellus suck each 10s of histamine of 62.5,125,250,500,1000 μ g/ml successively, the change of record Guinea Pig Airway flow velocity, tidal volume and transpulmonary pressure.Calculate the concentration (PC of histamine when lung resistance increases by 100%
100).
4. according to preliminary result, animal is divided into 12 groups, often organizes 8, specifically divide into groups in table 3.
Table 3 experimental design and grouping
Note: group 1 is model group.
5. result: Guinea Pig Airway instillation administration is after 0.5 hour, and Cavia porcellus aerosol sucks the histamine of variable concentrations, and the Guinea pig lung resistance that administration group all can obviously suppress histamine to be induced increases.Concentration (the PC of histamine when increasing by 100% by calculating lung resistance
100), result shows, each treatment group PC
100value is all apparently higher than model group (p<0.001-0.01).Wherein, the effect of Tio and For use in conjunction the most obviously (p<0.001), the effect of Tio and For drug combination is obviously better than alone For-0.7 μ g/kg treatment group (p<0.01-0.05), and the effect of Tio-0.7 μ g/kg, 1.4 μ g/kg and For drug combination is obviously better than alone Tio-1.4 μ g/kg treatment group (p<0.01-0.05).This result shows, and Tio-0.7 μ g/kg and For-0.35 μ g/kg, Tio-0.7 μ g/kg and For-0.7 μ g/kg, Tio-1.4 μ g/kg and the effect of For-0.7 μ g/kg tri-coupling treatment groups are best and intensity is suitable.This result is pointed out, and the two medicine couplings of Tio-0.7 μ g/kg and For-0.35 μ g/kg are most preferably, and all the other drug doses of two groups, all higher than this group, can increase the untoward reaction (see table 4) of two medicines.In this research, the dosage range of Tio is 0.35-1.4 μ g/kg, the dosage range of For is 0.175-0.7 μ g/kg, according to body surface area conversion ratio calculation between humans and animals, the dosage range of people's Clinical practice Tio is the dosage range of 9-36 μ g, For is 4.5-18 μ g.
Table 4.Tio and For is on the impact of the guinea pig bronchial contractile response that histamine causes
Compare with model group: * * p<0.01, * * * p<0.001
Compare with Tio-1.4 μ g/kg dosage group: #p<0.05, ##p<0.01
Compare with For-0.7 μ g/kg dosage group: & p<0.05, & & p<0.01
Embodiment 3
Containing the inhalation aerosol of tiotropium bromide and formoterol
Tiotropium bromide 1.125g
Formoterol 0.45g
Ethanol 2000g
HFA134a8000g
Aluminum pipe, metering valve 1000 overlaps
Make altogether 100 suctions/, 1000.
Technique:
Formoterol and tiotropium bromide are scattered in ethanol in a suitable manner, and then quantitative separating enters aluminium pot and with suitable metering valve crimping, forms withstand voltage hermetic container; By pressure filling, recipe quantity HFA134a propellant is loaded hermetic container.
Embodiment 4:
Containing the inhalation solution of tiotropium bromide and formoterol
Tiotropium bromide 33.75mg
Formoterol 13.5mg
Tween 80 2g
Water for injection 2000ml
Make 1000 altogether
By surfactant dissolves in water for injection, then add formoterol and tiotropium bromide and stir and obtain homodisperse drug solvent system, aseptically quantitative filling after filtration sterilization, often props up 2ml.
Embodiment 5:
Containing the inhalation powder spray of tiotropium bromide and formoterol
Component A:
Tiotropium bromide 22.5mg
Formoterol 9mg
Lactose monohydrate (200 order) 25g
Make 1000 suctions altogether
In lactose monohydrate, add formoterol and the tiotropium bromide of recipe quantity, by stirring and evenly mixing, quantitative filling, in suction device, often inhales 25mg
Embodiment 6:
Containing the inhalation powder spray of tiotropium bromide and formoterol
Component A:
Tiotropium bromide 22.5mg
Formoterol 9mg
Lactose monohydrate (80 order) 25g
Make 1000 suctions altogether
In lactose monohydrate, add formoterol and the tiotropium bromide of recipe quantity, by stirring and evenly mixing, quantitative filling, in suction device, often inhales 25mg.
Embodiment 7:
Containing the inhalation powder spray of tiotropium bromide and formoterol
Component A:
Tiotropium bromide 22.5mg
Formoterol 9mg
Lactose monohydrate (400 order) 25g
Make 1000 suctions altogether
In lactose monohydrate, add formoterol and the tiotropium bromide of recipe quantity, by stirring and evenly mixing, quantitative filling, in suction device, often inhales 25mg
Embodiment 8
According to Chinese Pharmacopoeia 2010 editions annex XH droplet (grain) algoscopys, TI mensuration is carried out to tiotropium bromide formoterol compound recipe powder spray, operates as follows:
1. install instruments TI, adds receiving liquid (I grade adds 7ml solvent, and II grade adds 30ml solvent);
2. regulate flow velocity to 60 ± 2L/min;
3. powder charge, vertically punctures capsule, inserts throat;
4. open three-phase valve, bleed 10s;
5. close three-phase valve;
6. repeat said process and complete 5 capsules mensuration
Powder spray TI measurement result sees the following form.
Claims (10)
1. a pharmaceutical composition, its active component is grouped into by following two one-tenth: 1) tiotropium bromide or its pharmaceutically acceptable salt, 2) formoterol or its pharmaceutically acceptable salt.
2. pharmaceutical composition as claimed in claim 1, is characterized in that: the mass ratio of tiotropium bromide and formoterol is: 9 ~ 36:4.5 ~ 18 (μ g/ μ g).
3. pharmaceutical composition described in claim 1 is for the preparation of the application of medicine for the treatment of respiratory tract and pulmonary inflammation disease.
4. pharmaceutical composition described in claim 1 is for the preparation of the application of the medicine of the protective effect to bronchoconstriction and airway hyperreactivity.
5. the application of the medicine of respiratory system disease that causes for the preparation for the treatment of bronchoconstriction of pharmaceutical composition described in claim 1.
6. the application according to claims 5, is characterized in that: described respiratory system disease mainly comprises dyspnea, chronic obstructive pulmonary disease and bronchial asthma.
7. the suction preparation of pharmaceutical composition according to claim 1, described suction preparation comprises inhalation solution, inhalation aerosol, inhalation powder spray.
8. suck preparation according to claim 7, it is characterized in that: said preparation also comprises the pharmaceutic adjuvant that one or more are applicable to pulmonary's inhaled medication.
9. suction preparation according to claim 7, is characterized in that: described pharmaceutical composition is micropowder, and the particle diameter of micropowder is 0.2-10 μm.
10. suction preparation according to claim 7, is characterized in that: suck preparation and often press containing tiotropium bromide 9 μ g ~ 36 μ g, formoterol 4.5 μ g ~ 18 μ g.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN107496388A (en) * | 2017-09-19 | 2017-12-22 | 上海方予健康医药科技有限公司 | A kind of powderous preparations containing Formoterol and tiotropium salt composition and preparation method thereof |
| CN110152003A (en) * | 2019-07-10 | 2019-08-23 | 温州医科大学附属第一医院 | A kind of compound medicine and preparation method thereof for treating COPD |
| CN110876807A (en) * | 2018-09-06 | 2020-03-13 | 天津金耀集团有限公司 | Spray containing surfactant for anticholinergic medicine |
| CN111467498A (en) * | 2020-05-14 | 2020-07-31 | 王兆霖 | Pharmaceutical composition preparation |
| WO2024051683A1 (en) * | 2022-09-05 | 2024-03-14 | 立生医药(苏州)有限公司 | Pharmaceutical composition for inhalation for preventing or treating respiratory disease |
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| CN1338928A (en) * | 1999-02-08 | 2002-03-06 | 诺瓦提斯公司 | Combinations of formoterol and a tiotropium salt |
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| CN1338928A (en) * | 1999-02-08 | 2002-03-06 | 诺瓦提斯公司 | Combinations of formoterol and a tiotropium salt |
| CN103687483A (en) * | 2011-05-17 | 2014-03-26 | 珍珠治疗公司 | Compositions, methods & systems for respiratory delivery of two or more active agents |
Non-Patent Citations (1)
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107496388A (en) * | 2017-09-19 | 2017-12-22 | 上海方予健康医药科技有限公司 | A kind of powderous preparations containing Formoterol and tiotropium salt composition and preparation method thereof |
| CN107496388B (en) * | 2017-09-19 | 2020-12-15 | 上海方予健康医药科技有限公司 | Powdery preparation containing formoterol and tiotropium salt composition and preparation method thereof |
| CN110876807A (en) * | 2018-09-06 | 2020-03-13 | 天津金耀集团有限公司 | Spray containing surfactant for anticholinergic medicine |
| CN110152003A (en) * | 2019-07-10 | 2019-08-23 | 温州医科大学附属第一医院 | A kind of compound medicine and preparation method thereof for treating COPD |
| CN110152003B (en) * | 2019-07-10 | 2021-06-22 | 温州医科大学附属第一医院 | Compound medicine for treating COPD and preparation method thereof |
| CN111467498A (en) * | 2020-05-14 | 2020-07-31 | 王兆霖 | Pharmaceutical composition preparation |
| WO2024051683A1 (en) * | 2022-09-05 | 2024-03-14 | 立生医药(苏州)有限公司 | Pharmaceutical composition for inhalation for preventing or treating respiratory disease |
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