CN106344544A - Aerosol inhalation preparation for treating bronchial asthma - Google Patents
Aerosol inhalation preparation for treating bronchial asthma Download PDFInfo
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- CN106344544A CN106344544A CN201610721278.7A CN201610721278A CN106344544A CN 106344544 A CN106344544 A CN 106344544A CN 201610721278 A CN201610721278 A CN 201610721278A CN 106344544 A CN106344544 A CN 106344544A
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- doxofylline
- preparation
- inhalation preparation
- bronchial asthma
- neulized inhalation
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- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0078—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
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- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
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- 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
- A61K9/08—Solutions
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- Life Sciences & Earth Sciences (AREA)
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Abstract
The invention relates to an aerosol inhalation preparation for treating bronchial asthma. The aerosol inhalation preparation contains doxofylline taken as an active substance, a solvent, a stabilizer and/or a pharmacologically acceptable carrier. According to the doxofylline aerosol inhalation preparation made from the components at specific ratio provided by the invention, the character, PH, insoluble particle, content, related substance and osmotic pressure are not obviously changed after 0-month acceleration, so that the doxofylline aerosol inhalation preparation by the invention is higher in stability. Meanwhile, the doxofylline aerosol inhalation solution has excellent atomization effect and high absorptivity and the effective dose below 5mu m reaches up to 50% or above.
Description
Technical field
The present invention is belonging to pharmaceutical technology field, is related to a kind of Neulized inhalation preparation, particularly to a kind of for treatment
The Neulized inhalation preparation of san bronchial asthma.
Background technology
Purpose using medicinal inhalant is treatment respiratory tract pulmonary disease and systemic disease, and medicine must be delivered to
Site of action or absorption site just can work.Medicine is directly proportional in the infiltration rate of pulmonary, fat-soluble to medicine, medicine
Molecular weight is inversely proportional to.During inhalation, atomization particle may not all can reach in major absorption site-alveolar.Local to lung
Effect is it is considered that granule is advisable with 3~10 μm of sizes;But play general action to rapid absorption, best particle diameter little to 0.5
~5 μm.When bronchodilator medicine is with inhalation, if containing substantial amounts of big particle, the ratio reaching Main Function position is little;
At present, most inhalants administration, because medicine is in the loss in oral cavity, bottleneck throat, calm in the tract of respiratory apparatus each position,
And because of expiration, loss of air-breathing etc., therefore actually enter alveolar and absorbed principal agent percentage rate is not high.Atomized inhalation at present
Commercialized product is relatively fewer, predominantly imported product, domestic commercially available less.But it is clinically more with injection inhalation.But
All there is no the operation instruction method of specification in injection description, and some atomizations can be led to abnormal using injection atomization,
Droplet size skewness is produced, it is not of uniform size to suck diameter of particle, it is few to enter alveolar volume after injection atomization, thus cannot
Guarantee that the accurate using dosage of patient reaches therapeutic effect.
Bronchial asthma (abbreviation asthma, asthma) is to threaten a kind of common chronic disease of public health in global range,
Countries in the world prevalence is from 0.13% to 17%.And its M & M is in the trend being gradually increasing.According to the whole world
Asthma prevents and treats the statistics of agreement, and the whole world has 1.6 hundred million people to suffer from this disease, the morbidity of asthma in many area 10-20
Rate increased 1 times.In many countries, no matter the financial burden for the treatment of asthma is in direct Medical Consumption, or indirect Medical Consumption
Aspect is all quite heavy so that the preventing and controlling of asthma are being first developed importantly by pendulum in the Strategy for Health service Development of government
Position.The serious harm that asthma causes to the mankind has increasingly caused global concern.
Since the eighties, medical science obtains very big progress to the research of asthma.Determining asthma is a kind of with air flue
Based on a large amount of eosinophilic granulocyte (eos) infiltrations, the air flue supplemented by the infiltration such as mastocyte, lymphocyte and macrophage is chronic
Alterative inflammation disease, the airway pressure obstacle causing with airway hyperreactivity and thus is as main clinical characteristics.At it
In the regulation of pathogenesis, there are various lymphocytes and the participation of cytokine profiles, inflammation cell and inflammatory mediator;Think
Delayed asthma reaction is the best model of laboratory research bronchial asthma.Anti-allergy inflammation is established on clinical treatment control
Treatment is the primary Therapeutic Principle of asthma.Although medical circle has made some progress to the research of asthma in recent years, so far
The mechanism of asthma generation and asthmatic patient increases and increases in recent years basic reason still can not be illustrated completely.
Over nearly 20 years, the method actively seeking effectively to prevent and treat asthma, the always problem of the tireless exploration of the world of medicine are although new
Therapeutic Method and medicine be constantly applied to clinic, but for reducing the sickness rate of asthma, mortality rate and improve the pre- of asthma
Still lack effective means afterwards.
By a series of screening studies, discovery is a kind of can be with the preparation of atomization inspiration treatment bronchial asthma, said preparation system
For simple, rapid-action, short treating period, there is fine therapeutical effect to bronchial asthma.Main active of the present invention is doxofylline.
The chemical formula of doxofylline is 2-(7- theophylline methyl)-(1,3- dioxy cyclopenta -2- methyl) purine:
Doxofylline is the derivant of methylxanthine, and it is a kind of bronchodilator, directly acts on bronchus, lax gas
Pipe smooth muscle.Doxofylline is fat-soluble good, and molecular weight is little, suitable Neulized inhalation.Ratio clinically applied by the preparation of doxofylline
Wide, the dosage form of listing both at home and abroad is mainly tablet, injection at present.Oral solid formulation is easy to use, but effect is slow, raw
Thing availability is subject to individual variation big, and injection is rapid-action, but using being restricted, limitation is than larger.The suction preparation of the present invention, its
Nebulizer administration can be passed through;High quality standards are had to comply with according to the liquid preparation of the present invention, have that absorption is fast, curative effect is high,
Medicine can be directly acted on diseased region by bioavailability height no gastrointestinal toxic and side effects and irritating feature, with other mouths
Clothes are compared with injection, and atomized inhalation is more suitable for underage child and postoperative patient and old people.
Content of the invention
Present invention mainly solves existing technical problem, exploitation one kind treats bronchial asthma and can stable storage suitable mist
Change and suck preparation.
For above-mentioned purpose, the technical scheme that the present invention provides is as follows:
A kind of Neulized inhalation preparation for treating bronchial asthma, is placed in atomising device by medicinal liquid and obtains, described medicinal liquid
Including active constituents of medicine doxofylline, solvent and pharmaceutically acceptable carrier, wherein the concentration of doxofylline be 5~
20mg/ml, pharmaceutically acceptable carrier be 5~10mg/ml, described pharmaceutically acceptable carrier include stabilizer, etc.
Penetration enhancer, ph regulator.
Described stabilizer is one or more mixing in disodium edetate, tartaric acid and sodium pyrosulfite, stabilizer
Concentration is 0~1mg/ml.
Described isotonic agent is that one or more of sodium chloride, potassium chloride, glucose, Mannitol mix, and isotonic agent is dense
Spend for 5~9mg/ml.
Described ph regulator is that one or more of hydrochloric acid, sulphuric acid, phosphoric acid, sodium hydroxide, potassium hydroxide mix, ph value
It is adjusted to 4.5 ~ 6.5.
Preferred as the present invention, preparation 100ml Neulized inhalation preparation adopts following prescription: doxofylline 1.0g, according to ground
Acid disodium 0.05g, sodium chloride 0.9g, pure water add to 100ml, and are prepared using following preparation method: heating state
Under, add and be dissolved in pure water except the outside upper all the components of stating of sodium hydroxide, with the ph to 5.0 of sodium hydrate regulator solution, incite somebody to action
Resulting solution is filtered by sterilizing filter, after then filtering liquid medicine filling in 2~5ml low borosilicate ampoule bottle, by no
Bacterium processes and obtains final product doxofylline aerosol inhalation solution.
As the preferred version of the present invention, prepare 100ml Neulized inhalation preparation using following prescription: doxofylline 1.0g,
Tartaric acid 0.1g, potassium chloride 0.7g, pure water add to 100ml, and are prepared using following preparation method: under heating state,
Add and be dissolved in pure water, with the ph to 6.0 of sodium hydrate regulator solution, by gained except the outside upper all the components of stating of sodium hydroxide
Solution is filtered by sterilizing filter, after then filtering liquid medicine filling in 2~5ml ampoule bottle, 121 degree of high pressure steam sterilization
15min, obtains final product doxofylline Neulized inhalation preparation.
By the enforcement of above technical scheme, the present invention compared with prior art concrete advantages below:
Show through overtesting, the doxofylline Neulized inhalation preparation of the present invention, under specific proportioning and composition, has surprisingly found that
Indices (as character, ph, particulate matter, content, about material, osmotic pressure with accelerate 0 month compared with have no significant change,
Illustrate that the doxofylline suction formulation samples stability of the present invention is more preferable.Also find the atomization of doxofylline of the present invention in surprise simultaneously
Suction solution, atomizing effect is good, and absorbance is high, and 5 μm of effective dose is to be issued to more than 50%.
Brief description:
Describe embodiment of the present invention in detail below in conjunction with accompanying drawing, but the invention is not restricted to following examples, wherein:
Fig. 1 is obtained the ngi collection of illustrative plates of doxofylline aerosol inhalation solution for embodiment 2;
Fig. 2 is obtained the ngi collection of illustrative plates of doxofylline aerosol inhalation solution for embodiment 3;
Fig. 3 is that embodiment 3 accelerates 0 month relevant material pattern;
Fig. 4 is that embodiment 3 accelerates 3 months relevant material pattern.
Specific embodiment:
Embodiment 1:
Doxofylline | 1.0g |
Tartaric acid | 0.1g |
Potassium chloride | 0.7g |
Sodium hydroxide | (ph is adjusted to 6.0) in right amount |
Pure water adds to | 100ml |
Technique: under heating state, add and be dissolved in pure water except the outside upper all the components of stating of sodium hydroxide, adjusted with sodium hydroxide
The ph of solution to 6.0, resulting solution is filtered by sterilizing filter, and after then filtering, liquid medicine filling is in 2~5ml ampoule bottle
In, 121 degree of 15min of high pressure steam sterilization, obtain final product doxofylline Neulized inhalation preparation.
Embodiment 2:
Doxofylline | 1.0g |
Disodium edetate | 0.05g |
Sodium chloride | 0.9g |
Sodium hydroxide | (ph is adjusted to 5.0) in right amount |
Pure water adds to | 100ml |
Technique: under heating state, add and be dissolved in pure water except the outside upper all the components of stating of sodium hydroxide, adjusted with sodium hydroxide
The ph of solution to 5.0, resulting solution is filtered by sterilizing filter, and after then filtering, liquid medicine filling is in the low borosilicate of 2~5ml
In ampoule bottle, doxofylline aerosol inhalation solution is obtained final product by aseptic process.
Embodiment 3:
Doxofylline | 1.0g |
Disodium edetate | 0.1g |
Sodium chloride | 0.7g |
Sodium hydroxide | (ph is adjusted to 5.8) in right amount |
Pure water adds to | 100ml |
Technique: under heating state, add and be dissolved in pure water except the outside upper all the components of stating of sodium hydroxide, adjusted with sodium hydroxide
The ph of solution to 5.8, resulting solution is filtered by sterilizing filter, and after then filtering, liquid medicine filling is in 2~5ml low-density
In polyethylene ampoule bottle, doxofylline Neulized inhalation preparation is obtained final product by aseptic process.
Test 1: stability of drug products test:
With reference to Chinese Pharmacopoeia 9001 guideline, embodiment 2 and embodiment 3 are obtained doxofylline Neulized inhalation solution in 40
DEG C ± 2 DEG C, place 6 months under the conditions of relative humidity 75% ± 5%, record according to Chinese Pharmacopoeia Doxofylline Injection detection method
The stability data of product see table:
Fig. 3 is that embodiment 3 accelerates 0 month relevant material pattern, and Fig. 4 is that embodiment 3 accelerates relevant material pattern during March, above knot
Fruit proves: through 3 months accelerated tests, relevant material had no significant change to doxofylline Neulized inhalation solution of the present invention, its
He also has no significant change by indices, illustrates that this product is more stable.
Test 2: the survey of doxofylline aerosol inhalation solution breathing simulation effect of the present invention and atomizing air aerodynamic particle size
Fixed.
Instrument 1: respiration simulator model: brs1100 producer: Britain copley
Compressed Air Nebulizer model: inqua neb plus producer: German Bry medical science and technology company limited
Sample: embodiment 1, embodiment 2, each 2ml of embodiment 3
Method: according to the detection of Chinese Pharmacopoeia doxofylline content method.
Atomization delivers total amount result of study
Model | Tidal volume | Respiratory frequency | Respiratory waveform | Embodiment 1(mg) | Embodiment 2(mg) | Embodiment 3(mg) |
Adult | 500ml | 15 circulations/min | Sinusoidal | 5.62 | 5.76 | 5.90 |
Child | 155ml | 25 circulations/min | Sinusoidal | 3.65 | 3.78 | 3.82 |
Baby | 50ml | 30 circulations/min | Sinusoidal | 1.92 | 2.01 | 2.11 |
By the above results as can be seen that doxofylline of the present invention sucks preparation has preferable absorption in adult, child, baby,
In adult, Heavy metal total amount reaches more than 25%.
Instrument 2: ram (ngi) model of new generation: ngi-1104 producer: Britain copley
Compressed Air Nebulizer model: inqua neb plus producer: German Bry medical science and technology company limited
Sample: embodiment 2, each 2ml of embodiment 3
Method: according to the detection of Chinese Pharmacopoeia doxofylline content method.
Minuteness particle aerodynamic studies result
Fig. 1 is embodiment 2 minuteness particle ngi collection of illustrative plates, and Fig. 2 is embodiment 3 minuteness particle ngi collection of illustrative plates
By the above results as can be seen that the present invention is obtained sucks preparation minuteness particle median particle diameter all at 4 μm about, meet and suck
Preparation minuteness particle Particle size requirements, 5 μm of effective minuteness particle dosage is to be issued to more than 50% it was demonstrated that the present invention sucks preparation energy
Enough it is efficiently entering human body alveolar and play the effect for the treatment of.
Claims (6)
1. a kind of Neulized inhalation preparation for treating bronchial asthma, is placed in atomising device by medicinal liquid and obtains, its feature exists
Include active constituents of medicine doxofylline, solvent and pharmaceutically acceptable carrier, wherein doxofylline in described medicinal liquid
Concentration be 5~20mg/ml, pharmaceutically acceptable carrier is 5~10mg/ml, described pharmaceutically acceptable carrier bag
Include stabilizer, isotonic agent, ph regulator.
2. the Neulized inhalation preparation for treating bronchial asthma according to claim 1 is it is characterised in that described is steady
Determining agent is one or more mixing in disodium edetate, tartaric acid and sodium pyrosulfite, and the concentration of stabilizer is 0~1mg/ml.
3. the Neulized inhalation preparation for treating bronchial asthma according to claim 1 is it is characterised in that described etc.
Penetration enhancer is that one or more of sodium chloride, potassium chloride, glucose, Mannitol mix, and isotonic agent concentration is 5~9mg/ml.
4. the Neulized inhalation preparation for treating bronchial asthma according to claim 1 is it is characterised in that described ph adjusts
Section agent is that one or more of hydrochloric acid, sulphuric acid, phosphoric acid, sodium hydroxide, potassium hydroxide mix, and ph value is adjusted to 4.5 ~ 6.5.
5. the Neulized inhalation preparation for treating bronchial asthma according to claim 1 is it is characterised in that prepare 100ml
Neulized inhalation preparation adopts following prescription: doxofylline 1.0g, disodium edetate 0.05g, sodium chloride 0.9g, pure water add to
100ml, and prepared using following preparation method: under heating state, add and state all the components dissolving except sodium hydroxide is outside upper
In pure water, with the ph to 5.0 of sodium hydrate regulator solution, resulting solution is filtered by sterilizing filter, then incited somebody to action
After filter, liquid medicine filling, in 2~5ml low borosilicate ampoule bottle, obtains final product doxofylline aerosol inhalation solution by aseptic process.
6. the Neulized inhalation preparation for treating bronchial asthma according to claim 1 is it is characterised in that prepare 100ml
Neulized inhalation preparation adopts following prescription: doxofylline 1.0g, tartaric acid 0.1g, potassium chloride 0.7g, pure water add to 100ml,
And prepared using following preparation method: under heating state, add except sodium hydroxide outside upper state all the components be dissolved in pure
In water, with the ph to 6.0 of sodium hydrate regulator solution, resulting solution is filtered by sterilizing filter, medicine after then filtering
Liquid fill in 2~5ml ampoule bottle, 121 degree of 15min of high pressure steam sterilization, obtain final product doxofylline Neulized inhalation preparation.
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CN201610721278.7A CN106344544A (en) | 2016-08-25 | 2016-08-25 | Aerosol inhalation preparation for treating bronchial asthma |
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CN201610721278.7A CN106344544A (en) | 2016-08-25 | 2016-08-25 | Aerosol inhalation preparation for treating bronchial asthma |
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112618519A (en) * | 2019-12-23 | 2021-04-09 | 杭州百诚医药科技股份有限公司 | Compound doxofylline solution for inhalation and preparation method thereof |
CN113679690A (en) * | 2021-09-06 | 2021-11-23 | 复旦大学附属中山医院 | Theophylline dry powder preparation and preparation method and application thereof |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
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CN1939279A (en) * | 2001-10-26 | 2007-04-04 | 德艾公司 | Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease |
CN101797379A (en) * | 2010-03-15 | 2010-08-11 | 甘能金 | Combination humidifying liquor for ultrasonic atomization therapy |
-
2016
- 2016-08-25 CN CN201610721278.7A patent/CN106344544A/en active Pending
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN1939279A (en) * | 2001-10-26 | 2007-04-04 | 德艾公司 | Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease |
CN101797379A (en) * | 2010-03-15 | 2010-08-11 | 甘能金 | Combination humidifying liquor for ultrasonic atomization therapy |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN112618519A (en) * | 2019-12-23 | 2021-04-09 | 杭州百诚医药科技股份有限公司 | Compound doxofylline solution for inhalation and preparation method thereof |
CN112618519B (en) * | 2019-12-23 | 2022-07-01 | 杭州百诚医药科技股份有限公司 | Compound doxofylline solution for inhalation and preparation method thereof |
CN113679690A (en) * | 2021-09-06 | 2021-11-23 | 复旦大学附属中山医院 | Theophylline dry powder preparation and preparation method and application thereof |
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