CN113018280A - Solution preparation for ipratropium bromide inhalation and preparation method thereof - Google Patents
Solution preparation for ipratropium bromide inhalation and preparation method thereof Download PDFInfo
- Publication number
- CN113018280A CN113018280A CN202110225010.5A CN202110225010A CN113018280A CN 113018280 A CN113018280 A CN 113018280A CN 202110225010 A CN202110225010 A CN 202110225010A CN 113018280 A CN113018280 A CN 113018280A
- Authority
- CN
- China
- Prior art keywords
- ipratropium bromide
- inhalation
- preparation
- solution
- solution preparation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- 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
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/46—8-Azabicyclo [3.2.1] octane; Derivatives thereof, e.g. atropine, cocaine
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/06—Antiasthmatics
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Pulmonology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to the technical field of pharmaceutical preparations, and particularly discloses an ipratropium bromide inhalation solution preparation and a preparation method thereof. According to the method, the pH of the solution is adjusted to 3.1-3.3, and then the ipratropium bromide is added, and the brown glass ampoule bottle is used as a packaging material, so that the process impurities introduced in the preparation process are obviously reduced, meanwhile, the increase of unknown impurity types in the storage process is avoided, and the increase of impurity content in the storage process is reduced, so that the stability of the prepared solution preparation for the inhalation of the ipratropium bromide is ensured, and the curative effect of the solution preparation for the inhalation of the ipratropium bromide is improved; and the aim of not adding other auxiliary materials except sodium chloride in the ipratropium bromide inhalation solution preparation is fulfilled, the adverse effect caused by the auxiliary materials is avoided, and the problem of safe medication caused by the auxiliary materials is also avoided.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to an ipratropium bromide inhalation solution preparation and a preparation method thereof.
Background
Ipratropium bromide is a bronchodilator and is mainly used for clinically relieving bronchospasm and wheezing symptoms caused by Chronic Obstructive Pulmonary Disease (COPD); can also be used for preventing and treating asthma, especially suitable for patients who cannot tolerate the drugs due to muscle tremor and tachycardia generated by using beta receptor agonist.
At present, the inhalation preparations of ipratropium bromide on the market at home comprise an inhalation solution and an inhalation aerosol, and are listed in the catalog of basic medical insurance medicines. The ipratropium bromide inhalation solution was first developed by the pharmaceutical company brigling-bergahen, germany, under the trade name of atraven, with 2 mL: 250. mu.g and 2 ml: 500 μ g of two sizes. The preparation method of the currently domestic solution preparation for inhalation of ipratropium bromide mainly comprises the following steps: and (3) adding other components except the pH regulator into purified water for dissolving, then adding the pH regulator, filtering and filling to obtain the product. The long-term stability of the solution preparation for the inhalation of the ipratropium bromide prepared by the process is poor, and the quality stability of the product in the shelf life can not be ensured. Therefore, in order to improve the stability of the ipratropium bromide solution preparation for inhalation, some processes further add a stabilizer such as an antioxidant, a preservative, a metal ion complex, etc. to improve the stability of the preparation during use. However, the method of adding pharmaceutical excipients such as stabilizers to improve stability increases the risk of adverse reactions such as bronchospasm, increases the risk of medication safety, increases the process steps, and increases the production cost. Therefore, the development of a new preparation method which can improve the stability of the ipratropium bromide inhalation solution preparation and does not need to add auxiliary materials such as an antioxidant, a metal ion complexing agent and the like has very important significance for improving the medication safety of the ipratropium bromide inhalation preparation.
Disclosure of Invention
Aiming at the problems of poor stability and more auxiliary materials in the existing ipratropium bromide inhalation solution preparation, the invention provides the ipratropium bromide inhalation solution preparation and the preparation method thereof.
In order to solve the technical problems, the technical scheme provided by the invention is as follows:
a method for preparing a solution preparation for ipratropium bromide inhalation, comprising the following steps:
step a, adding an osmotic pressure regulator with the amount of a prescription into injection water with the total volume of 60-80% of the preparation volume, stirring and dissolving, adding a pH regulator to regulate the pH to 3.1-3.3, then adding ipratropium bromide with the amount of the prescription, stirring and dissolving, and supplementing the injection water to the preparation total amount to obtain ipratropium bromide liquid medicine;
and b, filtering the ipratropium bromide liquid medicine, filling the filtered ipratropium bromide liquid medicine into a brown glass ampoule bottle, and sterilizing to obtain the solution preparation for the ipratropium bromide inhalation.
In the process of research and development, the inventor finds that the number of unknown impurities in the solution preparation for the ipratropium bromide inhalation prepared according to the conventional process is increased in the process of placing, the total impurity content is increased, and the content of the ipratropium bromide is obviously reduced. In order to control the increase of unknown impurities and known impurities during storage and reduce the possible side effects caused by auxiliary materials, the inventor develops a novel preparation method of the solution preparation for the inhalation of the ipratropium bromide.
Compared with the prior art, the method for preparing the ipratropium bromide inhalation solution preparation, provided by the invention, has the advantages that the pH of the solution is adjusted to 3.1-3.3, and then the ipratropium bromide is added, and a brown glass ampoule bottle is used as a packaging material, so that process impurities introduced in the preparation process are obviously reduced, meanwhile, the increase of unknown impurity types in the storage process is avoided, the increase of impurity content in the storage process is reduced, the stability of the prepared ipratropium bromide inhalation solution preparation is ensured, and the curative effect of the ipratropium bromide inhalation solution preparation is improved; and the aim of not adding other auxiliary materials except sodium chloride in the ipratropium bromide inhalation solution preparation is fulfilled, the adverse effect caused by the auxiliary materials is avoided, and the problem of safe medication caused by the auxiliary materials is also avoided.
The preparation method of the ipratropium bromide inhalation solution preparation provided by the invention is simple in technological operation and high in working efficiency, the product does not contain any auxiliary materials such as a metal ion complexing agent, an antioxidant and a stabilizer, and only contains one auxiliary material sodium chloride, so that the adverse effect caused by the auxiliary materials is reduced, the long-term stability is good, and the aseptic level of the product is ensured and the safety of clinical medication of the product is greatly improved by adopting a terminal sterilization method.
Preferably, the osmotic pressure regulator is sodium chloride.
Preferably, the pH regulator is hydrochloric acid solution.
Preferably, the pH regulator is hydrochloric acid solution with the concentration of 0.08-0.12 mol/L.
Preferably, in step a, a pH adjusting agent is added to adjust the pH to 3.2.
Preferably, the pH of the solution is adjusted to 3.2 before the ipratropium bromide is added, so that the stability of the ipratropium bromide can be effectively improved, and process impurities introduced in the preparation process and impurities introduced in the degradation of the ipratropium bromide are reduced.
Preferably, in the step b, the sterilization mode is constant temperature sterilization at 121 ℃ for 12 min.
In the prior art, polyethylene or polypropylene is generally adopted as an inner package, high-temperature terminal sterilization cannot be adopted, and the high-temperature stability of ipratropium bromide is poor, so that the high-temperature terminal sterilization mode cannot be adopted generally. The invention adopts a unique preparation process and is matched with a brown glass bottle as a packing material, thereby realizing the process of over-sterilization at the constant temperature of 121 ℃ for 12min and achieving the sterilization process F0The process requirement is more than or equal to 12, the aseptic level of the product is improved,can also effectively shorten the sterilization time and improve the sterilization efficiency. The sterilization cost is reduced.
Preferably, the brown glass ampoule bottle is a brown medium borosilicate glass ampoule bottle.
In order to find out the reason why the long-term stability of the solution preparation for inhalation of ipratropium bromide is poor, the inventors have conducted a cause analysis from various aspects through creative thinking. In addition to the process itself being a critical factor, the inventors have found that the packaging material of the product also significantly affects the long term stability of the product. In the prior art, polyethylene or polypropylene inner packages are adopted as packing materials, and long-term research shows that the packing materials can cause the concentration of active ingredients in the liquid medicine of the ipratropium bromide inhalation solution preparation to be increased in the long-term storage process, and the packing materials are generally added with antioxidant 330, antioxidant 1076, antioxidant 1010, antioxidant 168 or antioxidant 1314 and other ingredients, so that the antioxidant ingredients can migrate into the liquid medicine in the long-term storage process, thereby generating a plurality of unknown impurities. Unknown impurities generated by the antioxidant, degradation impurities of ipratropium bromide and the like result in poor long-term stability of ipratropium bromide.
In addition, in the prior art, transparent polyethylene or polypropylene is used as an inner package, a functional material with a light shielding effect is used as an outer package, and the packaging specification is generally 10 pieces/bag. The maximum daily dosage is 2 according to the usage dosage, once the outer packaging bag is opened, the light-shielding requirement of the residual unused product cannot be ensured, and the stability of the residual unused product is reduced.
The invention adopts a special preparation process, takes the brown glass ampoule bottle as a packing material, obviously improves the long-term stability of the ipratropium bromide, has no other unknown impurities except the known impurities in the long-term storage process, has better product quality compared with the prior ipratropium bromide inhalation preparation, has higher safety, and simultaneously ensures the stability of a single ipratropium bromide inhalation solution preparation in use.
The invention also provides an ipratropium bromide inhalation solution preparation which is prepared by the preparation method of any one of the ipratropium bromide inhalation solution preparations.
Preferably, the ipratropium bromide solution preparation for inhalation consists of ipratropium bromide, sodium chloride, hydrochloric acid and water for injection, wherein, 0.118-0.131mg of ipratropium bromide, 8.1-8.9mg of sodium chloride and pH of the ipratropium bromide solution preparation for inhalation are 3.1-3.3 are contained in each 1mL of the ipratropium bromide solution preparation for inhalation.
Further preferably, the solution preparation for inhalation of ipratropium bromide contains 0.125mg of ipratropium bromide, 8.5mg of sodium chloride, and the pH of the solution preparation for inhalation of ipratropium bromide is 3.2 per 1mL of the solution preparation for inhalation of ipratropium bromide.
The ipratropium bromide inhalation solution preparation provided by the invention has a simple prescription, a sodium chloride isotonic system with good physiological compatibility is established only by adding sodium chloride, and the stability of the ipratropium bromide inhalation solution preparation is obviously improved on the premise of not introducing stabilizers such as an antioxidant or a complexing agent, so that the clinical application safety of the ipratropium bromide inhalation solution preparation is improved, and the ipratropium bromide inhalation solution preparation has a wide application prospect.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is further described in detail with reference to the following embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
In order to better illustrate the invention, the following examples are given by way of further illustration.
Example 1
This example provides an inhalation solution formulation of ipratropium bromide, formulated in the amounts shown in the following table:
ipratropium bromide 0.125g
Sodium chloride 8.5g
Proper amount of 0.1mol/L hydrochloric acid solution
Water for injection to 1000 mL.
The preparation method of the solution preparation for the ipratropium bromide inhalation comprises the following steps:
step a, adding a prescription amount of sodium chloride into 700mL of water for injection, stirring and dissolving, adding a 0.1mol/L hydrochloric acid solution to adjust the pH value to 3.2, then adding a prescription amount of ipratropium bromide, stirring and dissolving, and adding water for injection to the total preparation amount to obtain ipratropium bromide liquid medicine;
and b, filtering the ipratropium bromide liquid medicine, filling the filtered ipratropium bromide liquid medicine into a brown glass ampoule bottle, and sterilizing at the constant temperature of 121 ℃ for 12min to obtain the solution preparation for the ipratropium bromide inhalation.
Example 2
This example provides an inhalation solution formulation of ipratropium bromide, formulated in the amounts shown in the following table:
ipratropium bromide 0.131g
Sodium chloride 8.1g
Proper amount of 0.08mol/L hydrochloric acid solution
Water for injection to 1000 mL.
The preparation method of the solution preparation for the ipratropium bromide inhalation comprises the following steps:
step a, adding a prescription amount of sodium chloride into 600mL of injection water, stirring for dissolving, adding a 0.08mol/L hydrochloric acid solution for adjusting the pH value to 3.1, then adding a prescription amount of ipratropium bromide, stirring for dissolving, and supplementing the injection water to the total preparation amount to obtain ipratropium bromide liquid medicine;
and b, filtering the ipratropium bromide liquid medicine, filling the filtered ipratropium bromide liquid medicine into a brown glass ampoule bottle, and sterilizing at the constant temperature of 121 ℃ for 12min to obtain the solution preparation for the ipratropium bromide inhalation.
Example 3
This example provides an inhalation solution formulation of ipratropium bromide, formulated in the amounts shown in the following table:
ipratropium bromide 0.118g
Sodium chloride 8.9g
Proper amount of 0.12mol/L hydrochloric acid solution
Water for injection to 1000 mL.
The preparation method of the solution preparation for the ipratropium bromide inhalation comprises the following steps:
step a, adding a prescription amount of sodium chloride into 800mL of injection water, stirring for dissolving, adding a 0.12mol/L hydrochloric acid solution for adjusting the pH value to 3.3, then adding a prescription amount of ipratropium bromide, stirring for dissolving, and supplementing the injection water to the total preparation amount to obtain ipratropium bromide liquid medicine;
and b, filtering the ipratropium bromide liquid medicine, filling the filtered ipratropium bromide liquid medicine into a brown glass ampoule bottle, and sterilizing at the constant temperature of 121 ℃ for 12min to obtain the solution preparation for the ipratropium bromide inhalation.
Comparative example 1
This comparative example provides an inhalation solution formulation of ipratropium bromide, the dosage of the formulation being as shown in the following table:
ipratropium bromide 0.125g
Sodium chloride 8.5g
Proper amount of 0.1mol/L hydrochloric acid solution
Water for injection to 1000 mL.
The preparation method of the solution preparation for the ipratropium bromide inhalation comprises the following steps:
step a, adding a prescription amount of sodium chloride and ipratropium bromide into 700mL of water for injection, stirring for dissolving, adding a 0.1mol/L hydrochloric acid solution for adjusting the pH to 3.5, and adding the water for injection to the total preparation amount to obtain ipratropium bromide liquid medicine;
and b, filtering the ipratropium bromide liquid medicine and filling the filtered ipratropium bromide liquid medicine into an inner packaging layer made of low-density polyethylene to obtain the ipratropium bromide solution preparation for inhalation.
Comparative example 2
This example provides an inhalation solution formulation of ipratropium bromide, formulated in the amounts shown in the following table:
ipratropium bromide 0.125g
Sodium chloride 8.5g
Proper amount of 0.1mol/L hydrochloric acid solution
Water for injection to 1000 mL.
The preparation method of the solution preparation for the ipratropium bromide inhalation comprises the following steps:
step a, adding a prescription amount of sodium chloride into 700mL of injection water, stirring and dissolving, adding a 0.1mol/L hydrochloric acid solution to adjust the pH value to 3.5, then adding a prescription amount of ipratropium bromide, stirring and dissolving, and adding injection water to the total preparation amount to obtain ipratropium bromide liquid medicine;
and b, filtering the ipratropium bromide liquid medicine, filling the filtered ipratropium bromide liquid medicine into a brown glass ampoule bottle, and sterilizing at the constant temperature of 121 ℃ for 12min to obtain the solution preparation for the ipratropium bromide inhalation.
Comparative example 3
This comparative example provides an inhalation solution formulation of ipratropium bromide, the dosage of the formulation being as shown in the following table:
ipratropium bromide 0.125g
Sodium chloride 8.5g
Proper amount of 0.1mol/L hydrochloric acid solution
Water for injection to 1000 mL.
The preparation method of the solution preparation for the ipratropium bromide inhalation comprises the following steps:
step a, adding a prescription amount of sodium chloride and ipratropium bromide into 700mL volume of water for injection, stirring and dissolving, adding 0.1mol/L hydrochloric acid solution to adjust the pH value to 3.2, and adding water for injection to the total preparation amount to obtain ipratropium bromide liquid medicine;
and b, filtering the ipratropium bromide liquid medicine, filling the filtered ipratropium bromide liquid medicine into a brown glass ampoule bottle, and sterilizing at the constant temperature of 121 ℃ for 12min to obtain the solution preparation for the ipratropium bromide inhalation.
Stability of
60 pieces of the ipratropium bromide inhalation solution preparations prepared in examples 1 to 3 and comparative examples 1 to 3 were randomly sampled and examined at 60 ℃. + -. 2 ℃ for 0 day and 30 days, respectively, and the results are shown in Table 1 to Table 2.
Table 1 examples 1-3 test results of high temperature influencing factors
TABLE 2 comparative examples 1-3 test results of high temperature influencing factors
60 pieces of the ipratropium bromide inhalation solution preparations prepared in examples 1 to 3 and comparative examples 1 to 3 were randomly sampled and examined at 40 ℃ and RH 25% for 0 day, 3 months and 6 months, respectively, and the results are shown in tables 3 to 4.
TABLE 3 accelerated test results for examples 1-3
TABLE 4 accelerated test results of comparative examples 1-3
The detection method of related substances in the high-temperature influence factor test and the accelerated test comprises the following steps:
a chromatographic column: a C8 chromatography column;
mobile phase: 0.25% sodium heptanesulfonate monohydrate solution is used as a mobile phase A, and acetonitrile is used as a mobile phase B;
and (3) an elution mode: isocratic elution;
detection wavelength: 200-230 nm;
sample introduction amount: 70 mu L of the solution;
flow rate: 0.5-1.0 mL/min;
column temperature: 30-40 ℃.
Wherein the peak emergence time of ipratropium bromide is 7-8 min, the peak emergence time of impurity B is 8.5-9.5 min, the peak emergence time of impurity C is 2-3 min, and the peak emergence time of impurity F is 13-15 min.
Other quality test items such as visible foreign matter, properties, osmotic pressure, bacterial endotoxin and sterility test of the solution preparation for inhalation of ipratropium bromide prepared in examples 1 to 3 were in accordance with the regulations, and were also in accordance with the regulations during the high temperature test and the accelerated test.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents or improvements made within the spirit and principle of the present invention should be included in the scope of the present invention.
Claims (9)
1. A method for preparing an ipratropium bromide solution preparation for inhalation is characterized by comprising the following steps:
step a, adding an osmotic pressure regulator with the amount of a prescription into injection water with the total volume of 60-80% of the preparation volume, stirring and dissolving, adding a pH regulator to regulate the pH to 3.1-3.3, then adding ipratropium bromide with the amount of the prescription, stirring and dissolving, and supplementing the injection water to the preparation total amount to obtain ipratropium bromide liquid medicine;
and b, filtering the ipratropium bromide liquid medicine, filling the filtered ipratropium bromide liquid medicine into a brown glass ampoule bottle, and sterilizing to obtain the solution preparation for the ipratropium bromide inhalation.
2. The method of preparing an ipratropium bromide inhalation solution formulation of claim 1, wherein said tonicity modifier is sodium chloride.
3. The method of preparing an ipratropium bromide solution formulation for inhalation according to claim 1, wherein said pH adjusting agent is a hydrochloric acid solution.
4. The method for preparing the solution formulation for inhalation of ipratropium bromide according to claim 3, wherein said pH adjusting agent is hydrochloric acid solution having a concentration of 0.08-0.12 mol/L.
5. The method of preparing a solution formulation for inhalation of ipratropium bromide according to claim 1, wherein in step a, a pH adjusting agent is added to adjust the pH to 3.2.
6. The method for preparing ipratropium bromide solution formulation for inhalation according to claim 1, wherein in step b, said sterilization is performed by constant temperature sterilization at 121 ℃ for 12 min.
7. An ipratropium bromide solution preparation for inhalation, characterized by being prepared by the method for preparing the ipratropium bromide solution preparation for inhalation according to any one of claims 1 to 6.
8. The ipratropium bromide inhalation solution formulation according to claim 7, wherein said ipratropium bromide inhalation solution formulation consists of ipratropium bromide, sodium chloride, hydrochloric acid and water for injection, wherein 0.118-0.131mg of ipratropium bromide, 8.1-8.9mg of sodium chloride and pH 3.1-3.3 are contained per 1mL of ipratropium bromide inhalation solution formulation.
9. The ipratropium bromide inhalation solution formulation of claim 8, comprising 0.125mg of ipratropium bromide, 8.5mg of sodium chloride, and a pH of 3.2 per 1mL of ipratropium bromide inhalation solution formulation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110225010.5A CN113018280A (en) | 2021-03-01 | 2021-03-01 | Solution preparation for ipratropium bromide inhalation and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110225010.5A CN113018280A (en) | 2021-03-01 | 2021-03-01 | Solution preparation for ipratropium bromide inhalation and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN113018280A true CN113018280A (en) | 2021-06-25 |
Family
ID=76465016
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202110225010.5A Pending CN113018280A (en) | 2021-03-01 | 2021-03-01 | Solution preparation for ipratropium bromide inhalation and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN113018280A (en) |
Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1607940A (en) * | 2001-10-26 | 2005-04-20 | 德艾公司 | Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease |
| AU2006202585A1 (en) * | 2001-10-26 | 2006-07-13 | Mylan Specialty L.P. | An albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease |
| CN1921830A (en) * | 2003-12-31 | 2007-02-28 | 锡德克斯公司 | Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid |
| US20070264202A1 (en) * | 2004-09-09 | 2007-11-15 | Cipla Limited | Pharmaceutical Composition Comprising an Isomer of Betamimetic Agent and an Anti-Cholinergic Agent |
| US20070274925A1 (en) * | 2006-05-26 | 2007-11-29 | Dey, L.P. | Nebulizable compositions of quaternary ammonium muscarinic receptor antagonists |
| RU2496477C1 (en) * | 2012-09-20 | 2013-10-27 | Шолекс Девелопмент Гмбх | Ipratropium bromide solution |
| CN103690479A (en) * | 2013-12-04 | 2014-04-02 | 广东嘉博制药有限公司 | Glycopyrronium bromide injection and preparation method thereof |
| CN110876723A (en) * | 2018-09-06 | 2020-03-13 | 天津金耀集团有限公司 | Isopropyl tropium bromide spray containing surfactant |
-
2021
- 2021-03-01 CN CN202110225010.5A patent/CN113018280A/en active Pending
Patent Citations (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1607940A (en) * | 2001-10-26 | 2005-04-20 | 德艾公司 | Albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease |
| AU2006202585A1 (en) * | 2001-10-26 | 2006-07-13 | Mylan Specialty L.P. | An albuterol and ipratropium inhalation solution, system, kit and method for relieving symptoms of chronic obstructive pulmonary disease |
| CN1921830A (en) * | 2003-12-31 | 2007-02-28 | 锡德克斯公司 | Inhalant formulation containing sulfoalkyl ether cyclodextrin and corticosteroid |
| US20070264202A1 (en) * | 2004-09-09 | 2007-11-15 | Cipla Limited | Pharmaceutical Composition Comprising an Isomer of Betamimetic Agent and an Anti-Cholinergic Agent |
| US20070274925A1 (en) * | 2006-05-26 | 2007-11-29 | Dey, L.P. | Nebulizable compositions of quaternary ammonium muscarinic receptor antagonists |
| RU2496477C1 (en) * | 2012-09-20 | 2013-10-27 | Шолекс Девелопмент Гмбх | Ipratropium bromide solution |
| CN103690479A (en) * | 2013-12-04 | 2014-04-02 | 广东嘉博制药有限公司 | Glycopyrronium bromide injection and preparation method thereof |
| CN110876723A (en) * | 2018-09-06 | 2020-03-13 | 天津金耀集团有限公司 | Isopropyl tropium bromide spray containing surfactant |
Non-Patent Citations (1)
| Title |
|---|
| NPS MEDICINEWISE: "Consumer medicine information,Atrovent Nasal,Ipratropium bromide", 《CONSUMER MEDICINE INFORMATION,ATROVENT NASAL,IPRATROPIUM BROMIDE，HTTPS://WWW.NPS.ORG.AU/MEDICINE-FINDER/ATROVENT-NASAL-SPRAY》 * |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN110934816B (en) | Method for improving stability of low-concentration atropine ophthalmic preparation | |
| CN111481501B (en) | Ketorolac tromethamine injection capable of reducing irritation and free of organic solvent | |
| WO2022222630A1 (en) | Multiple electrolytes injection and preparation method therefor | |
| CN108159026B (en) | Stable ambroxol hydrochloride solution for inhalation and preparation method thereof | |
| CN104644551B (en) | A kind of pharmaceutical composition containing Fasudic hydrochloride of injection | |
| CN113018280A (en) | Solution preparation for ipratropium bromide inhalation and preparation method thereof | |
| CN108743527B (en) | Tirofiban hydrochloride injection and preparation method thereof | |
| EP4265260A1 (en) | Stable liquid pharmaceutical composition containing kuding saponin compound | |
| CN105640876A (en) | Preparation process of moxifloxacin hydrochloride sodium chloride injection | |
| CN111265474B (en) | Parthenocinolate injection and preparation method thereof | |
| CN112569184A (en) | Tirofiban hydrochloride injection and preparation method thereof | |
| CN111265475B (en) | Isoniazid injection and preparation method thereof | |
| CN103830171B (en) | A kind of Ketorolac tromethamine injection and preparation method thereof | |
| CN110812325B (en) | Method for improving storage stability of ketorolac tromethamine injection | |
| CN104434788B (en) | A kind of preparation method of atenolol injection | |
| CN104288099B (en) | Preparation method of ibuprofen injection | |
| CN107281096A (en) | A kind of liquid drugs injection containing Peramivir and preparation method thereof | |
| CN114344251A (en) | Preparation method of paclitaxel injection | |
| CN114931551B (en) | Miku ammonium chloride injection with storage stability at 25 ℃ and preparation method and application thereof | |
| CN108888593A (en) | A kind of atenolol injection and preparation method thereof | |
| CN117771222B (en) | Leifenacin inhalation spray and preparation method thereof | |
| CN117257731A (en) | Pentoxifylline Injection | |
| CN110314132B (en) | Ornithine aspartate injection and preparation method thereof | |
| CN115844819A (en) | Preparation method of salbutamol sulfate injection | |
| CN117244082A (en) | I-Meipril injection and preparation method thereof |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination |