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Method for preparing salbutamol compound inhalation aerosol

A technology of salbutamol and levosalbutamol, which is applied in the field of biomedicine, can solve the problems of low bioavailability and poor compliance with clinical medication, and achieve good lung deposition, improve drug compliance, and rapid onset of effect

Inactive Publication Date: 2015-11-25
SICHUAN XUSHENG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to taking oral albuterol and ketotifen, two drugs need to be taken at the same time, the clinical medication compliance is not good, and the bioavailability of oral drugs for the treatment of local respiratory diseases is much lower than that of other dosage forms such as aerosol inhalation

Method used

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  • Method for preparing salbutamol compound inhalation aerosol
  • Method for preparing salbutamol compound inhalation aerosol
  • Method for preparing salbutamol compound inhalation aerosol

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] 1. Formula: calculated according to 1000 bottles:

[0059]

[0060] 2. Preparation method:

[0061] 1) Micronization of raw materials: pulverizing levosalbutamol sulfate and ketotifen fumarate;

[0062] 2) Weighing: take by weighing formula amounts of L-salbutamol sulfate, ketotifen fumarate, oleic acid, absolute ethanol, anhydrous sodium sulfate;

[0063] 3) Surfactant dissolution: Add the surfactant to absolute ethanol, slowly add the formulated amount of levosalbutamol sulfate and ketotifen fumarate, stir and continue until a clear and transparent solution is formed;

[0064] 4) Drying: Add the desiccant in the prescribed amount, stir and dry for 30 minutes, and then filter through a titanium rod to remove the desiccant;

[0065] 5) Filling and tying valves, filling propellant tetrafluoroethane, leak detection and weighing;

[0066] 6) Packaging: install the actuator (cover).

Embodiment 2

[0068] 1. Formula: calculated according to 1000 bottles:

[0069]

[0070]

[0071] 2. Preparation method:

[0072] The preparation method is the same as in Example 1.

experiment example 1

[0073] Experimental Example 1 Particle Size Measurement

[0074] The droplet size distribution was determined by laser diffraction using a Mastersizer 3000 (Malvern Instruments, Worcs, UK). The powder was measured to be dispersed by a Scirocco 3000 aerosol feeder (Malvern Instruments, Worcs, UK) with compressed air at 4 bar. The particles have a refractive index and absorptivity of 1.52 and 0.1, respectively, and the dispersant has a refractive index of 1.000 for air. All measurements were performed in three cycles and the results are shown in Tables 1 and 2 and figure 1 with figure 2 .

[0075] Table 1 Example 1 sample particle size distribution

[0076]

Dv10

Dv50

Dv90

Average particle size (μm)

1.41

3.54

4.87

standard deviation(%)

0.03

0.03

0.05

[0077] Table 2 Example 2 sample particle size distribution

[0078]

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Abstract

The invention discloses compound inhalation aerosol and a method for preparing the same. The compound inhalation aerosol comprises sulfuric acid levalbuterol which is an active constituent, ketotifen fumarate which is another active constituent, surfactants, diluents / complex solubilizers and propellants. The method includes micronizing crude medicines, and to be more specific, grinding the sulfuric acid levalbuterol and the ketotifen fumarate by the aid of an airflow grinder; weighing formulated amounts of the sulfuric acid levalbuterol, the ketotifen fumarate, the surfactants, anhydrous ethanol and anhydrous sodium sulfate; dissolving the surfactants; adding the surfactants into the anhydrous ethanol, slowly adding the formulated amounts of the sulfuric acid levalbuterol and the ketotifen fumarate into the anhydrous ethanol, and continuously stirring the anhydrous ethanol until clear transparent liquor is formed; drying the liquor, to be more specific, adding a formulated amount of drying agents into the liquor, stirring and drying the liquor for 30min, and filtering the drying agents by the aid of titanium rods; filling tying valves with the liquor, filling the valves with tetrafluoroethane of the propellants, detecting leakage and carrying out weighing; packaging the compound inhalation aerosol, and to be more specific, mounting a mobility aid (case).

Description

technical field [0001] The invention relates to the field of biomedicine, in particular to a preparation method of albuterol ketotifen aerosol. Background technique [0002] Asthma, also known as bronchial asthma, is a chronic airway inflammation involving a variety of cells and cell components. This inflammation is often accompanied by increased airway reactivity, resulting in recurrent wheezing, shortness of breath, chest tightness and / or coughing Such symptoms usually occur at night and / or in the early morning. These symptoms are often accompanied by extensive and variable airflow obstruction, which can be reversed spontaneously or through treatment. [0003] Cough variant asthma (Cough Variant Asthma, CVA), also known as cough asthma, is a special type of early bronchial asthma and is one of the common causes of chronic cough in children. [0004] Studies have shown that 70% of bronchial asthma is allergic asthma. At present, CVA is considered to be a special type of br...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4535A61K9/12A61P11/06A61K31/137
Inventor 祝国华王楠丁多浩李克江刘成吴晓波
Owner SICHUAN XUSHENG PHARMA CO LTD
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