Capsule type budesonide dry powder inhalation and preparation process thereof

A technology of budesonide and preparation process, which can be used in capsule delivery, powder delivery, respiratory diseases, etc., can solve the problems of increasing the burden on the lungs and easily entering the lungs, reducing the burden on the lungs and improving the yield of finished products , the effect of the simple method

Active Publication Date: 2010-12-22
SHANGHAI SINE PROMOD PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this method, the main ingredient is mixed and ground together with a small amount of excipients, and then the auxiliary materials are added by an equal amount incremental method. However, it is not completely suitable for industrial production, and, in this method, the powder mist after the excipients are ground, When the patient uses it, it is easy to enter the lungs, which increases the burden on the lungs

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Formula: budesonide 0.16g, lactose 20g.

[0021] Take the budesonide raw material, dry it at 60°C for 2 hours, let it cool to room temperature; put the raw material into a fluid energy mill for micronization treatment; put the main drug after the micronization treatment under a microscope to observe the micronized budesonide with a particle size of 1 μm-5 μm The der ratio should reach 50%. Take lactose, pulverize it, and pass through a 100-mesh sieve; after powdering, granulate the lactose with 50% (W / W) ethanol solution, pass through a 20-mesh sieve, place in an oven at 60°C for about 30 minutes, pass through a 40-mesh sieve for granulation, and dry. Pass through a 80-mesh sieve and set aside. Take the micronized main ingredient and the blank lactose granules in proportion to the prescription amount, and mix them by the method of equal multiplication and increment. After mixing evenly, take samples from different parts of the powder to measure the content of budesoni...

Embodiment 2

[0023] Formula: budesonide 0.2g, lactose 25g.

[0024] Take the budesonide raw material, dry it at 60°C for 2 hours, let it cool to room temperature; put the raw material into a fluid energy mill for micronization treatment; put the main drug after the micronization treatment under a microscope to observe the micronized budesonide with a particle size of 1 μm-5 μm The der ratio should reach 70%. Take lactose, pulverize it, and pass through a 100-mesh sieve; after powdering, granulate the lactose with 50% (W / W) ethanol solution, pass through a 20-mesh sieve, place in an oven at 60°C for about 30 minutes, pass through a 40-mesh sieve for granulation, and dry. Pass through a 80-mesh sieve and set aside. Take the micronized main ingredient and the blank lactose granules in proportion to the prescription amount, and mix them by the method of equal multiplication and increment. After mixing evenly, take samples from different parts of the powder to measure the content of budesonid...

Embodiment 3

[0026] Formula: budesonide 0.24g, lactose 30g.

[0027] Take the budesonide raw material, dry it at 60°C for 2 hours, let it cool to room temperature; put the raw material into a fluid energy mill for micronization treatment; put the main drug after the micronization treatment under a microscope to observe the micronized budesonide with a particle size of 1 μm-5 μm The Derby ratio should reach 60%. Take lactose, pulverize it, and pass through a 100-mesh sieve; after powdering, granulate the lactose with 50% (W / W) ethanol solution, pass through a 20-mesh sieve, place in an oven at 60°C for about 30 minutes, pass through a 40-mesh sieve for granulation, and dry. Pass through a 80-mesh sieve and set aside. Take the micronized main ingredient and the blank lactose granules in proportion to the prescription amount, and mix them by the method of equal multiplication and increment. After mixing evenly, take samples from different parts of the powder to measure the content of budeso...

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PUM

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Abstract

The invention provides a capsule type budesonide dry powder inhalation and a preparation process thereof. The budesonide dry powder inhalation comprises the following components by weight: 0.16 g-0.24 g of budesonide and 20 g-30 g of lactose. As blank lactose granules are prepared, the invention can control the loading quantity easily during split charging and improve the product yield and is beneficial for industrial production. When being used, the invention reduces the content of auxiliaries entering the lung when a patient takes medicine to ease the lunge burden of the patient, reduces the side effect during the medication and has relatively large application value.

Description

Technical field: [0001] The invention relates to pharmaceutical preparations, in particular to a capsule-type budesonide powder mist inhaler and a preparation process thereof. Background technique: [0002] The pathogenesis of asthma is mainly chronic non-specific inflammation. At present, anti-inflammatory therapy is still the main treatment for bronchial asthma, which makes corticosteroids the first choice for the treatment of various types of asthma. Budesonide is a glucocorticoid, developed by AstraZeneca in the 1990s, which can enhance the stability of endothelial cells, smooth muscle cells and lysosomal membranes, suppress immune responses and reduce antibody synthesis, thereby reducing tissue The release of allergic active mediators such as amines and the reduction of their activity can alleviate the enzymatic process stimulated by the combination of antigen and antibody, thereby inhibiting the synthesis and release of bronchoconstrictive substances and reducing the ...

Claims

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Application Information

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IPC IPC(8): A61K31/58A61K47/26A61K9/14A61K9/72A61K9/48A61P11/06
Inventor 胡林森
Owner SHANGHAI SINE PROMOD PHARMA
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