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Ketotifen fumarate sterile nasal spray and preparation method thereof

A technology of ketotifen fumarate and nasal spray, which is used in pharmaceutical formulations, aerosol delivery, respiratory diseases, etc., can solve the problems of high production equipment requirements, human health damage, human harm and other problems, and achieve significant curative effects , reduce toxicity, simple operation effect

Inactive Publication Date: 2018-03-06
YANGTAI PHARMA SHANDONG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Nasal inhalation aerosols contain propellants, long-term use is potentially harmful to the human body, and the requirements for production equipment are relatively high; at the same time, existing nasal drops and nasal sprays contain preservatives, which are produced by killing or inhibiting Drugs that prevent the proliferation of microorganisms from decay will have certain side effects if used improperly; some preservatives even contain trace amounts of toxins, long-term intake, accumulation in the body will cause certain damage to human health

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] A kind of ketotifen fumarate nasal spray, its composition is as follows:

[0017] serial number

[0018] Dissolve ketotifen fumarate in water for injection, add prescribed amount of EDTA and glycerin, dilute to corresponding volume with water for injection, then add appropriate amount of 0.1% sodium hydroxide solution to adjust pH to 5.0, use 0.22 μm The bacteria filter is used to sterilize and filter the obtained solution, and the obtained solution can be filled into the nasal spray device used in CN200980156096.8, and sealed for preservation.

Embodiment 2

[0020] A kind of ketotifen fumarate nasal spray, its composition is as follows:

[0021] serial number

[0022] Dissolve ketotifen fumarate in water for injection, add prescribed amount of EDTA and glycerin, dilute to corresponding volume with water for injection, then add appropriate amount of 0.1% sodium hydroxide solution to adjust pH to 5.0, use 0.22 μm The bacteria filter is used to sterilize and filter the obtained solution, and the obtained solution can be filled into the nasal spray device used in CN200980156096.8, and sealed for storage.

Embodiment 3

[0024] A kind of ketotifen fumarate nasal spray, its composition is as follows:

[0025] serial number

[0026] Dissolve ketotifen fumarate in water for injection, add prescribed amount of EDTA and glycerin, dilute to corresponding volume with water for injection, then add appropriate amount of 0.1% sodium hydroxide solution to adjust pH to 5.0, use 0.22 μm The bacteria filter is used to sterilize and filter the obtained solution, and the obtained solution can be filled into a conventional nasal spray device and sealed for preservation.

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PUM

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Abstract

The invention belongs to the field of pharmaceutical preparations and in particular relates to ketotifen fumarate sterile nasal spray and a preparation method thereof. The ketotifen fumarate sterile nasal spray is prepared from the following main components: ketotifen fumarate, EDTA (Ethylene Diamine Tetraacetic Acid), glycerol, sodium hydroxide and water for injection; the obtained pharmaceuticalpreparation does not contain a preservative and the toxin, caused by the preservative, on nose cilium can be reduced; damages, caused by the fact that a medicine containing the preservative is used for long time, to bodies are reduced; meanwhile, the form of the pharmaceutical preparation of the nasal spray can be accurately metered; the ketotifen fumarate sterile nasal spray is relatively convenient to use and a preparation technology is simple.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a ketotifen fumarate sterile nasal spray and a preparation method thereof. technical background [0002] Ketotifen (Fumarate) is an antihistamine and antiallergic drug, and its fumarate is commonly used. It is mainly used clinically for the prevention and treatment of allergic asthma and allergic rhinitis asthma syndrome, and is considered to be a drug with (Steroid-sparing effect) steroid-like effect but without steroid side effects. It also has a certain preventive effect on non-allergic asthma, such as exercise-induced asthma, aspirin-induced asthma, and occupational asthma. The curative effect of ketotifen on children's asthma is particularly remarkable, and the curative effect reaches more than 80%. The double-blind test confirmed that long-term oral administration of ketotifen can achieve the same efficacy as cromolyn sodium in improving asthma symptoms, and the...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/4535A61K47/18A61K47/10A61P37/08A61P11/06A61P11/02
CPCA61K9/0043A61K9/12A61K31/4535A61K47/10A61K47/183
Inventor 张路陈延龙范昆静
Owner YANGTAI PHARMA SHANDONG
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