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Pharmaceutical composition containing individually-packaged ciclesonide and epinephrine beta2-acceptor stimulant placed in inhalation device for synchronous application

A technology of receptor agonist and epinephrine, which is applied in the direction of drug combination, drug delivery, and medical preparations containing active ingredients, etc., and can solve complex, different particle size characteristics, and difficult problems

Inactive Publication Date: 2014-12-17
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, glucocorticoids and adrenergic β2-receptor agonists have different granule characteristics and dosages, and the above situation is more complicated in the presence of excipients
For example, in the process of filling into the same container during production, it is difficult to maintain a high degree of uniformity due to different powder and particle properties.

Method used

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  • Pharmaceutical composition containing individually-packaged ciclesonide and epinephrine beta2-acceptor stimulant placed in inhalation device for synchronous application
  • Pharmaceutical composition containing individually-packaged ciclesonide and epinephrine beta2-acceptor stimulant placed in inhalation device for synchronous application
  • Pharmaceutical composition containing individually-packaged ciclesonide and epinephrine beta2-acceptor stimulant placed in inhalation device for synchronous application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Grind ciclesonide and adrenergic β2-receptor agonist respectively. The particle sizes are shown in the table below. The crushed drugs are mixed with 20 times the weight of lactose with an average particle size of 30 μm according to the above method, and 100 μg of ciclesonide / grain, adrenergic β2-receptor agonist 10 μ g / grain standard filling drug capsules, aluminum foil blister packaging, each kind of medicine gets 10 grains to measure the drug content, and is marked as 0 day value. Afterwards, 100 capsules of each drug were taken and stored for 6 months at a temperature of 30±2°C and a relative humidity of 65±5%, and then 10 capsules were randomly selected to measure the drug content, emptying rate, and uniformity, which were marked as 6-month values The results are shown in the table below.

[0028] Uniformity determination method: according to the Chinese Pharmacopoeia 2010 edition two appendix XE "content uniformity inspection method" test.

[0029] Determinatio...

Embodiment 1

[0032] Take the pulverized ciclesonide and adrenergic β2-receptor agonist in Example 1, the particle size is shown in the table below, the pulverized medicine is mixed uniformly according to the above method, and then mixed with 20 times the weight of lactose with an average particle size of 30 μm according to Mix the above methods, fill drug capsules according to the standard of 100 μg / grain of ciclesonide and 10 μg / grain of adrenoceptor β2-receptor agonist, and pack in aluminum foil blisters, take 10 capsules of each compound drug to measure the drug content, and mark it as 0 days value. Afterwards, 100 capsules of each drug were taken and stored for 6 months at a temperature of 30±2°C and a relative humidity of 65±5%, and then 10 capsules were randomly selected to measure the drug content, emptying rate, and uniformity, which were marked as 6-month values See the table below for the results.

[0033]

Embodiment 2

[0035] Grind ciclesonide and adrenergic β2-receptor agonist respectively. The particle sizes are shown in the table below. The crushed drugs are mixed with 20 times the weight of lactose with an average particle size of 45 μm according to the above method, and 100 μg of ciclesonide / grain, adrenergic β2-receptor agonist 10 μg / grain standard put into the double barrel inhalation device.

[0036]

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Abstract

The invention relates to a drug for treating respiratory tract diseases especially asthma, and especially relates to a dry powder inhalation pharmaceutical composition containing ciclesonide and epinephrine beta2-acceptor stimulant, which are individually packaged and placed in a same inhalation device for synchronous application.

Description

Technical field: [0001] The invention relates to a drug for treating respiratory diseases, especially asthma, in particular to a dry powder inhalation pharmaceutical composition in which ciclesonide and adrenergic β2-receptor agonist are packaged separately and used simultaneously in an inhalation device. Background technique: [0002] Asthma is a chronic airway inflammation characterized by reversible airway obstruction and increased airway responsiveness. Airway obstruction is caused by two factors: increased secretions caused by bronchial mucosal inflammation, mucosal edema, and smooth muscle spasm stimulated by inflammation; while asthma Increased airway reactivity is also a result of damage to the bronchial epithelium due to airway inflammation. It is recognized that only by controlling the inflammation of the airway mucosa can the ultimate goal of reducing airway hyperresponsiveness and relieving asthma symptoms be achieved. Drugs for the treatment of asthma and other...

Claims

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Application Information

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IPC IPC(8): A61P11/00A61K31/58A61K9/72A61P11/06A61K45/00
Inventor 孙亮赵琳
Owner TIANJIN JINYAO GRP