Ambroxol powder aerosol, its preparation method and application

A technology of ambroxol and powder spray, which is applied in the field of pharmacy and pharmacy, can solve the problem of few active ingredients of the drug, and achieve the effect of simple process, easy realization and cost saving

Inactive Publication Date: 2012-08-01
INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But this ambroxol powder aerosol action position is in lung, and the drug active ingredient that really reaches sputum position (ie trachea and bronchi) is seldom

Method used

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  • Ambroxol powder aerosol, its preparation method and application
  • Ambroxol powder aerosol, its preparation method and application
  • Ambroxol powder aerosol, its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1: the preparation of ambroxol powder spray sample 1

[0052] The present embodiment ambroxol hydrochloride powder spray is capsule type powder spray. Based on 1000 capsules:

[0053]

[0054] Preparation:

[0055] In the water for injection, add mannitol and anhydrous citric acid, add ambroxol hydrochloride to the solution after dissolving, heat to 65-75°C, cool after dissolving, and adjust the pH of the obtained solution to 4.5-5.0 with an appropriate amount of sodium hydroxide. The solution is placed in a freeze dryer to freeze-dry, and the obtained freeze-dried powder cake is ground and then crushed with a jet mill so that the aerodynamic particle size is between 5 μm and 15 μm to obtain ambroxol powder aerosol sample 1.

[0056] Those skilled in the art can understand that although the weight unit of each component (except water for injection) in the above prescription is g, it can also be understood as parts by weight, that is, it is enough for e...

Embodiment 2

[0057] Embodiment 2: the preparation of ambroxol powder spray sample 2

[0058] The present embodiment ambroxol hydrochloride powder spray is capsule type powder spray. Based on 1000 capsules:

[0059]

[0060]

[0061] Preparation:

[0062] In the water for injection, add mannitol and phosphoric acid, add ambroxol hydrochloride to the solution after dissolving, heat to 65-75°C, cool after dissolving, adjust the pH of the obtained solution to 4.5-5.0 with an appropriate amount of sodium hydroxide, and place the solution in Freeze-dry in a freeze dryer, grind the obtained freeze-dried powder cake, and then use a jet mill to pulverize it so that the aerodynamic particle size is between 5 μm and 15 μm, measure the content uniformity of the main drug, fill it into capsules after passing the test, and obtain Capsule type ambroxol hydrochloride powder spray is Ambroxol powder spray sample 2.

[0063] Those skilled in the art can understand that although the weight unit of...

Embodiment 3

[0064] Embodiment 3: the preparation of ambroxol powder spray sample 3

[0065] The present embodiment ambroxol hydrochloride powder spray is capsule type powder spray. Based on 1000 capsules:

[0066]

[0067] Preparation:

[0068] In the water for injection, add mannitol and phosphoric acid, add ambroxol hydrochloride to the solution after dissolving, heat to 65-75°C, cool after dissolving, adjust the pH of the obtained solution to 4.5-5.0 with an appropriate amount of sodium hydroxide, and place the solution in Freeze-dry in a freeze dryer, grind the obtained freeze-dried powder cake, and then use a jet mill to pulverize it so that the aerodynamic particle size is between 5 μm and 15 μm, measure the content uniformity of the main drug, fill it into capsules after passing the test, and obtain Capsule type ambroxol hydrochloride powder spray is Ambroxol powder spray sample 3.

[0069] Those skilled in the art can understand that although the weight unit of each compon...

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Abstract

Belonging to the fields of pharmacology and pharmaceutics, the invention relates to an ambroxol powder aerosol, its preparation method and application. Specifically, the ambroxol powder aerosol contains ambroxol and/or a medicinal salt thereof, as well as a pharmaceutically acceptable auxiliary material. The ambroxol powder aerosol is characterized by having an aerodynamic particle size greater than 5 micrometers and less than or equal to 15 micrometers. The ambroxol powder aerosol of the invention can target a lesion part (a trachea and/or a bronchus). In addition, the preparation method prepared in the invention greatly reduces the material loss in production, and has the advantages of cost saving, simple process, as well as easy implementation.

Description

technical field [0001] The invention belongs to the field of pharmacy and pharmacy, and relates to an ambroxol powder spray, its preparation method and application. Background technique [0002] Ambroxol (Ambroxol) is an expectorant widely used clinically at present. It is mainly used to treat patients who have sputum but are difficult to cough up due to thick sputum, or for acute and chronic bronchopulmonary diseases with poor expectoration function. Phlegm treatment, especially the thick sputum and dyspnea caused by acute exacerbation of chronic bronchitis, chronic obstructive pneumonia, wheezing bronchitis, bronchial asthma and other diseases. In addition, ambroxol is also used for the preventive treatment of postoperative pulmonary complications and the treatment of infant respiratory distress. [0003] The inner walls of the trachea and bronchi are covered with a layer of mucosa, which is composed of ciliated columnar epithelium and goblet cells. There are many mucous ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/137A61P11/10
Inventor 梅兴国孙思平
Owner INST OF PHARMACOLOGY & TOXICOLOGY ACAD OF MILITARY MEDICAL SCI P L A
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