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Inhalation formulation containing n-acetyl-l-cysteine ​​and fluticasone propionate and process for its preparation

A technology of fluticasone propionate and cysteine, which is applied in the field of drugs for the treatment of respiratory diseases, especially asthma, can solve the problems of large dosage, achieve the effect of improving airway remodeling and good therapeutic effect

Active Publication Date: 2016-02-03
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Lei Ling et al. (Antioxidant properties of N-acetylcysteine ​​and its therapeutic effect on chronic obstructive pulmonary disease, International Journal of Respiratory Volume 26, No. 5, 2006; 388-391) have disclosed that NAC can produce anti-inflammatory effects when taken orally. Oxidation, thus producing a certain therapeutic effect on chronic obstructive pulmonary disease. However, in the above two documents, the dosage of NAC is relatively large, and the daily dose reaches more than 300mg.

Method used

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  • Inhalation formulation containing n-acetyl-l-cysteine ​​and fluticasone propionate and process for its preparation
  • Inhalation formulation containing n-acetyl-l-cysteine ​​and fluticasone propionate and process for its preparation

Examples

Experimental program
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Effect test

Embodiment 1

[0035] Dissolve 80 mg of fluticasone propionate and 1 g of N-acetyl-L-cysteine ​​in ethanol. After filtration, the filtrate is spray-dried and micronized to make the average particle size reach 2 μm. 10 g of lactose is micronized to the average particle size by a flow energy mill 20μm, after mixing, pass through a 200-mesh sieve for 3 times, mix evenly, and pack in No. 3 capsules. Fluticasone propionate 80μg, N-acetyl-L-cysteine ​​1mg per capsule

[0036] The process conditions are: the inlet temperature is 105°C, the outlet temperature is 68, the air flow rate is 90%, the inner diameter of the nozzle outlet is 0.1cm, the air flow rate of the nozzle is 800ml / min, and the injection speed is 50mL / h

Embodiment 2-1

[0038] Dissolve 250mg of fluticasone propionate and 2500mg of N-acetyl-L-cysteine ​​in ethanol. After filtering, the filtrate is spray-dried and micronized to make the average particle size reach 4μm. Lactose 40g is micronized to the average particle size by a fluid energy mill. The diameter is 30 μm, mix well, mix well with 200 mesh sieve for 3 times, then pack into No. 3 capsules. Each capsule contains fluticasone propionate 250μg, N-acetyl-L-cysteine ​​2500μg.

[0039] The process conditions are as follows: inlet temperature is 105°C, outlet temperature is 68°C, air flow rate is 90%, nozzle outlet inner diameter is 0.1cm, nozzle air flow rate is 800ml / min, and sample injection speed is 50mL / h.

Embodiment 2-2

[0041] According to the formulation of Example 2-1, the carrier was changed to octaacetate-D-cellobiose octaacetate with an average particle size of 35 μm, and the powder spray was prepared according to the process of Example 2-1.

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Abstract

The invention relates to an inhalant containing N-acetyl-L-cysteine and fluticasone propionate and a preparation method thereof. The inhalant is composed of fluticasone propionate and N-acetyl-L-cysteine as the active ingredients, and one or more pharmaceutical adjuvants suitable for inhalation administration.

Description

Technical field: [0001] The invention relates to a medicine for treating respiratory diseases, especially asthma, in particular to an inhalation powder spray and a preparation method thereof. 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. At present, the drugs for the treatment of asthma and other lung diseases mainly include the following: (1) β2-receptor agonists, (2) xanthine drugs, (3) anti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/56A61K31/198A61P11/06
Inventor 孙亮陈松赵琳
Owner TIANJIN JINYAO GRP
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