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Budesonide R capsule type inhalation dust cloud agent and preparation method thereof

A technology for inhaling powder aerosols and capsules is applied to pharmaceutical preparations for the treatment of respiratory diseases, especially asthma, and their preparation, and in the field of capsule-type inhalation powder aerosols, which can solve problems affecting the quality of inhalation powder aerosol preparations and the feasibility of scaling up production. The inhalation powder has poor fluidity and small average particle size of the preparation, and achieves the effect of less adverse reactions, good fluidity, and small difference in preparation quality.

Inactive Publication Date: 2009-04-08
CAPITAL UNIVERSITY OF MEDICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing method mixes and grinds the main ingredient and the excipient together, which brings problems as follows: (1) The average particle size of the preparation made by co-grinding is small, and the powder fluidity is poor. The difficulty of dividing doses increases; (2) The excipients are all ground into the lungs, which increases the burden on the lungs
Therefore, the budesonide inhalation powder aerosol prepared by the prior art has poor fluidity, thereby affecting the preparation quality and the feasibility of scale-up production of the inhalation powder aerosol

Method used

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  • Budesonide R capsule type inhalation dust cloud agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Mix 0.96g of budesonide R and 30.0g of lactose evenly, micronize by mechanical pulverization to make the average particle size reach 1-5μm, add 170.0g of lactose less than 160μm in equal amount, stir evenly, and pass through a 100-mesh sieve 3 Times, mixed and packed in No. 3 HPMC capsules.

[0036] Process conditions: low temperature planetary ball mill, 42Hz, 550 rpm, grinding for 3 hours.

Embodiment 2

[0038] Mix 0.96g of budesonide R and 30.0g of lactose evenly, and prepare a certain proportion of ethanol solution, micronize it by spray drying method to make the average particle size reach 1-5μm, and add 170.0g of lactose less than 160μm in equal amount , stir evenly, pass through a 100-mesh sieve for 3 times, mix well and pack into No. 3 HPMC capsules.

[0039] Process conditions: Spray dryer, inlet temperature 105°C, outlet temperature 80°C, sample injection speed 1600mL / h, nozzle air velocity 3.9m / s.

Embodiment 3

[0041] Mix 0.96g of budesonide R and 60.0g of lactose evenly, micronize them by mechanical pulverization to make the average particle size reach 1-5μm, add 140.0g of lactose less than 160μm according to the equal amount incremental method, stir evenly, and pass through a 100-mesh sieve 3 times, mix well and pack into No. 3 HPMC capsules.

[0042] Process conditions: low temperature planetary ball mill, 42Hz, 550 rpm, grinding for 3 hours.

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Abstract

The invention discloses a budesonide R capsulated powder inhalation and a method for preparing the same. The budesonide R capsulated powder inhalation comprises a capsule shell and capsule contents which consist of 0.1 to 10 percent of budesonide R ultra-fine powder and 90 to 99.9 percent of carrier, wherein the average particle diameter of the budesonide R ultra-fine powder is between 1 and 5 mu m, and the particle diameter of the carrier is less than 160 mu m.

Description

Technical field: [0001] The present invention relates to medical inhalation powder, more specifically to a capsule-type inhalation powder made from a composition of budesonide R and excipients, a pharmaceutical preparation for treating respiratory diseases, especially asthma, and its preparation method. Background technique: [0002] Asthma is a chronic airway inflammation characterized by reversible airway obstruction and increased airway reactivity, characterized by recurrent episodes, often manifested by widespread and variable airflow limitation. Airway obstruction is caused by increased secretions caused by bronchial mucosal inflammation, mucosal edema, and inflammation-stimulated smooth muscle spasm; and increased airway responsiveness is also the result of bronchial epithelial cell damage caused by airway inflammation. Studies have shown that early inhalation of glucocorticoids is of great significance for controlling symptoms, reducing airway hyperresponsiveness, an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/58A61K9/14A61K9/72A61P11/06
Inventor 崔纯莹崔国辉孙怡王飞
Owner CAPITAL UNIVERSITY OF MEDICAL SCIENCES
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