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Emulsion type nasal spray containing ciclesonide, and application thereof

A technology of ciclesonide and emulsion type, which is applied in the field of medicine, can solve the problems of poor water solubility, etc., and achieve the effects of low local side effects, convenient use, and high bioavailability

Inactive Publication Date: 2011-09-28
FUKANGREN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] According to the present invention, ciclesonide is poor in water solubility, but has the characteristics of moderate fat solubility, and preparing it into an emulsion can overcome the disadvantage of its poor water solubility, and at the same time prepare the emulsion into a nasal spray

Method used

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  • Emulsion type nasal spray containing ciclesonide, and application thereof
  • Emulsion type nasal spray containing ciclesonide, and application thereof
  • Emulsion type nasal spray containing ciclesonide, and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013]

[0014] Preparation:

[0015] First, measure 500ml of water for injection, dissolve the prescribed amount of glycerin and disodium calcium edetate in it, dissolve ciclesonide and soybean lecithin in soybean oil, and heat appropriately to promote dissolution. Then mix the water phase and the oil phase to prepare colostrum, then add it to a high-pressure homogenizer for circulation and homogenization treatment, take it out, adjust the pH value to 6-8 with 0.1mol / L NaOH, and then add the remaining amount of water for injection, Filter 5 times with a 200nm microporous membrane to further homogenize the particle size and remove larger particles.

Embodiment 2

[0017]

[0018]

[0019] Preparation:

[0020] First, measure 500ml of water for injection, dissolve the prescribed amount of glycerin in it, dissolve ciclesonide and egg yolk lecithin in soybean oil, and heat appropriately to promote dissolution. Then add the water phase and the oil phase to the high-pressure homogenizer in turn for circulation and homogenization treatment, take it out, adjust the pH value to 6-8 with 0.1mol / L NaOH, add the rest of the water for injection, filter with 200nm microporous Membrane filtration 5 times to further homogenize the particle size and remove larger particles.

Embodiment 3

[0022]

[0023] Preparation:

[0024] First measure 500ml of water for injection, dissolve the prescribed amount of mannitol in it, dissolve ciclesonide and soybean lecithin in castor oil, and heat to promote dissolution. Then add the water phase and the oil phase to the high-pressure homogenizer in turn for circulation and homogenization treatment, take it out, adjust the pH value to 6-8 with 0.1mol / L NaOH, add the rest of the water for injection, filter with 200nm microporous Membrane filtration 5 times to further homogenize the particle size and remove larger particles.

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PUM

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Abstract

The invention relates to an emulsion type nasal spray containing ciclesonide, and an application thereof, in particular to an emulsion type nasal spray prepared from ciclesonide and pharmaceutically acceptable solvents or surfactants, and an application thereof. The emulsion type nasal spray is prepared from ciclesonide as an active component and pharmaceutically acceptable auxiliary materials by a certain preparation process, and can be used for treating asthma, allergic rhinitis and chronic obstructive pulmonary disease. In the invention, ciclesonide is used as an active component and some specific kinds and proportions of auxiliary materials are added to develop the emulsion type nasal spray according to the preparation process specified by the invention, and the dosage form has very ideal physical and chemical stabilities and excellent administration characteristics.

Description

technical field [0001] An emulsion nasal spray containing ciclesonide and its application. The invention relates to an emulsion-type nasal spray with ciclesonide as an active ingredient, its preparation process and application, and belongs to the technical field of medicine. Background technique [0002] Asthma is one of the most common diseases in the world today. In industrialized countries, 6%-12% of adults and children suffer from asthma, resulting in tens of billions of dollars in socioeconomic losses. There are more than 500 million people suffering from asthma in the world. In 2000, the annual incidence rate of asthma in Chinese residents was 1.2%, and that of children was about 2% to 3%. The total number was 15.6 million. Compared with 1980, the total incidence rate increased by 75%. [0003] Ciclesonide is a new generation of corticosteroid anti-asthma drug that can be activated and inhaled, and is used to treat adults, children and adolescents over 4 years old w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/58A61K47/34A61P11/00A61P11/02A61P11/06A61P37/08
Inventor 不公告发明人
Owner FUKANGREN BIO PHARMA
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