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Fluticasone propionate spraying agent with improved stability

A technology of fluticasone propionate and spray, applied in the field of pharmaceutical preparations, can solve problems such as the stability affecting the quality of preparations, and achieve the effects of stable droplet distribution, convenient and stable pH value adjustment

Inactive Publication Date: 2014-07-02
CHONGQING HUAPONT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Through research, we found that after long-term storage of the preparation, the spray pattern and droplet distribution will change to a certain extent, which will affect the stability of the preparation quality.

Method used

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  • Fluticasone propionate spraying agent with improved stability
  • Fluticasone propionate spraying agent with improved stability
  • Fluticasone propionate spraying agent with improved stability

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Embodiment 1 prepares fluticasone propionate spray 1

[0036] Party:

[0037]

[0038] 1) Drug dispersion: Weigh 0.3g of Tween 80, dissolve it with an appropriate amount of water as a dispersion medium, then add 0.25g of fluticasone propionate into the dispersion medium, and disperse evenly to obtain Intermediate A.

[0039] 2) Dissolution of excipients: Dissolve 6g of glucose, 0.05g of benzalkonium chloride, 0.5g of phenylethyl alcohol and 10g of edetate disodium in appropriate amount of water, then add 4.5g of microcrystalline cellulose + sodium carboxymethyl cellulose, Fully swollen to obtain intermediate B.

[0040] 3) Mixing: take intermediate A and intermediate B, mix them evenly, and fill them in a bottle of 16g ​​to obtain the finished fluticasone propionate spray.

Embodiment 2～6

[0041] Embodiment 2~6 prepares fluticasone propionate spray 2-6

[0042] Recipe: See Table 1. Preparation method: with embodiment 1.

[0043] The prescription of fluticasone propionate spray in table 1 embodiment 1~6

[0044]

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Abstract

The invention provides a fluticasone propionate spraying agent with improved stability. According to the invention, it is found for the first time that a combined stabilizing agent can be formed by adding disodium edetate into conventional antiseptics--benzalkonium chloride and phenylethyl alcohol, which enables the fluticasone propionate spraying agent to have better stability compared with traditional preparations. After long-term storage, the spraying mode and a droplet distribution scope of the fluticasone propionate spraying agent basically maintain unchanged; the pH value of the preparation is maintained in a proper range without usage of a pH value adjusting agent, and the pH value basically maintains unchanged after long-term storage. The invention further provides a preparation method for the spraying agent.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a fluticasone propionate nasal spray with stable quality and a preparation method thereof. Background technique: [0002] Fluticasone propionate is a glucocorticoid drug. In recent years, Glaxo has developed a fluticasone propionate spray for the treatment of allergic rhinitis. [0003] Spray is a special liquid preparation, which is sprayed on the affected part through a power device during use. [0004] For aerosols, the spray pattern (the ratio of the length of the longest axis to the shortest axis in the spray pattern of the aerosol, e.g. figure 1 X / Y) and droplet distribution (the particle size distribution of the sprayed droplets) are critical. Because different spray patterns mean different distribution of active ingredients in the affected area, and different droplet distribution means different amounts of active ingredients. The "Chinese Pharmacopoeia 2010 E...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/56A61K47/38A61K47/18A61P11/02A61P37/08
Inventor 兰洁陈李平张颖陈博
Owner CHONGQING HUAPONT PHARMA
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