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Ketotifen fumarate tablets and preparation method thereof

A technology of ketotifen fumarate and ketone fumarate, which is applied in the field of medicine, can solve the problems of Gram-positive bacteria invasion, heat source influence, and non-recommended use, so as to eliminate the possibility of heat source and reduce the risk of heat source Effect

Inactive Publication Date: 2020-03-27
仁和堂药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, ketotifenol fumarate is used in nasal sprays or tablets. Since some of the objects are children, the use of sprays may cause discomfort if improperly handled, so it is not recommended to use them; and if tablets are used, there is a heat source effect, which may cause skin irritation. Invasion of Lambert-positive bacteria

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0013] The ketotifen fumarate tablet consists of 40 parts by mass of ketotifen fumarate, 14 parts of hydroxypropyl cellulose, 1 part of magnesium stearate and 1 part of starch.

Embodiment 2

[0015] The ketotifen fumarate tablet consists of 80 parts by mass of ketotifen fumarate, 10 parts of hydroxypropyl cellulose, 5 parts of magnesium stearate and 2 parts of starch.

Embodiment 3

[0017] The ketotifen fumarate tablet consists of 60 parts by mass of ketotifen fumarate, 7 parts of hydroxypropyl cellulose, 2 parts of magnesium stearate and 1 part of starch.

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PUM

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Abstract

The invention relates to ketotifen fumarate tablets and a preparation method thereof. The ketotifen fumarate tablets disclosed by the invention comprise the following components in parts by mass of 40-90 parts of ketotifen fumarate, 7-18 parts of hydroxypropyl cellulose, 1-5 parts of magnesium stearate and 1-2 parts of starch. Besides, the invention further discloses a preparation method of the ketotifen fumarate tablets. The ketotifen fumarate is preprocessed in low-temperature environment, so that the risk of heat sources in ketotifen fumarate raw materials can be reduced; and in the later preparation process, low-temperature preparation is continuously performed, so that the possibility that the heat sources exist is further stopped.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a ketotifen fumarate tablet and a preparation method thereof. Background technique [0002] Ketotifen fumarate is a second-generation histamine H1 receptor antagonist with strong histamine H1 receptor antagonistic effect. It was launched in 1979 and is used in Europe, Asia, Australia and many other regions. Chinese Pharmacopoeia 2000 edition Pack its tablets. Ketotifen fumarate is clinically mainly used for the prevention and quality of allergic asthma and allergic rhinitis asthma syndrome, and is considered to be a drug with steroid-like effects but without steroid side effects. Ketotifen fumarate is particularly effective in the treatment of children's asthma, with a curative effect of more than 80%. At present, ketotifenol fumarate is used in nasal sprays or tablets. Since some of the objects are children, the use of sprays may cause discomfort if improperly handled, so it...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/36A61K47/12A61K31/4535A61P11/06
CPCA61K9/2013A61K9/2054A61K9/2059A61K31/4535A61P11/06
Inventor 孙运玲王世礼胡百忠宿晓法
Owner 仁和堂药业有限公司
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