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Method for preparing betamethasone dipropionate atomization inhalant

A technology of betamethasone dipropionate and atomized inhalation, which is applied in the field of preparation of betamethasone dipropionate atomized inhaler, can solve the problems of unsuitability for industrialized production, long reaction time, and easy pollution of the environment, and achieve Short action time, less drug dosage, good dispersion stability

Inactive Publication Date: 2013-03-20
SUZHOU UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method uses volatile toxic solvents such as acetone and methylene chloride, which is easy to pollute the environment; moreover, it needs to further process microcrystals to prepare atomized inhalants, which is complicated to operate, takes a long time to react, and is prone to bacterial contamination, so it is not suitable for industrial production.

Method used

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  • Method for preparing betamethasone dipropionate atomization inhalant
  • Method for preparing betamethasone dipropionate atomization inhalant
  • Method for preparing betamethasone dipropionate atomization inhalant

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Control group 1: the raw material of betamethasone dipropionate was dissolved in sterilized water to obtain the first suspension.

[0069] Control group 2: the first suspension was sheared at a high speed of 13,000 rpm by a disperser to obtain a second suspension.

[0070] Control group 3: Take 1 g of sodium taurocholate and dilute it 100 times with sterilized water to obtain a sodium taurocholate dilution. Take 30mL of sodium taurocholate dilution in 300mL of sterilized water, use a disperser to shear at 13,500 rpm at high speed, accurately weigh 60 mg of betamethasone dipropionate, slowly add it to the high-speed sheared sterilized water, and After shearing for 5 min, a third suspension was obtained.

[0071] Test group: the third suspension was treated with a high-pressure micro-jet homogenizer at a pressure of 1200 bar, and circulated 3 times, 6 times, 9 times, 10 times, 20 times, and 30 times respectively to obtain the fourth suspension and the fifth suspension ,...

Embodiment 2 2

[0077] The preparation of embodiment 2 betamethasone dipropionate atomized inhalation

[0078] Take 30g of bovine serum albumin, dissolve it in 270mL of sterilized water, use a disperser to shear at 13,500 rpm at high speed, accurately weigh 81mg of betamethasone dipropionate, and slowly add it to the high-speed sheared sterilized water, High-speed shearing for 5 minutes, homogenization treatment by a high-pressure micro-fluidic homogenizer at a processing pressure of 1800 bar, 60 cycles, and filter sterilization to obtain a stable suspension of betamethasone dipropionate.

Embodiment 3 2

[0079] The preparation of embodiment 3 betamethasone dipropionate atomized inhalation

[0080] Take 0.5 g of Tween 80, dissolve it in 300 mL of sterilized water, use a disperser to shear at 17,000 rpm at high speed, accurately weigh 15 g of betamethasone dipropionate, and slowly add it to the high-speed sheared sterilized water, High-speed shearing for 4 minutes, homogenization treatment by a high-pressure micro-fluidic homogenizer at a processing pressure of 300 bar, 290 cycles, and filter sterilization to obtain a stable suspension of betamethasone dipropionate.

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Abstract

The invention relates to the field of medical products, in particular to a method for preparing a betamethasone dipropionate atomization inhalant. The method comprises the following steps: dispersing betamethasone dipropionate into water to obtain suspension, homogenizing, sterilizing, and thus obtaining the betamethasone dipropionate atomization inhalant, wherein the homogenizing pressure is 200 to 2,000 bar. The preparation method is green and environment-friendly, simplifies the operation steps, can realize continuous operation, and is short in acting time, sterile, pollution-free and suitable for industrialized production. The prepared betamethasone dipropionate atomization inhalant has the advantages of high dispersion stability, high lung deposition rate, low medicament consumption, high bioavailability and low toxic or side effect.

Description

technical field [0001] The invention relates to the field of pharmaceutical products, in particular to a preparation method of betamethasone dipropionate atomized inhalation. Background technique [0002] Bronchial asthma (asthma for short) is a chronic inflammatory disease of the airway, leading to airway hyperresponsiveness, extensive and variable airflow limitation, and recurrent symptoms such as wheezing, shortness of breath, chest tightness or coughing, often in Onset and exacerbation at night or in the early morning, most patients can relieve themselves or be relieved by treatment. Asthma is an important disease that affects people's physical and mental health. If it is not treated in time and not standardized, asthma may be fatal. At present, there are about 300 million asthmatics in the world, and about 30 million asthmatics in China. [0003] A fast and effective way to treat asthma is to deliver inhaled glucocorticoids to the lungs through the Pulmonary Drug Deli...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/10A61K31/573A61P11/06
Inventor 李浩莹宋爽郭静靳奇峰徐恩宇陈曦姜峻峰
Owner SUZHOU UNIV
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