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Ketotifen fumarate tablets and application 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: 2020-08-04
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

[0011] A kind of ketotifen fumarate tablet of the present invention is realized like this: ketotifen fumarate tablet comprises following mass fraction: 30~50 parts of ketotifen fumarate, 5~12 parts of hydroxypropyl cellulose, 1-3 parts of magnesium stearate and 1-2 parts of starch;

[0012] The preparation of ketotifen fumarate tablet comprises the following steps:

[0013] 1) Ketotifen fumarate pretreatment: Take ketotifen fumarate and dissolve it in distilled water at room temperature, and use centrifugal stirring for 30-40 minutes to form a ketotifen fumarate solution, ketotifen fumarate and distilled water The added mass ratio of ketotifen fumarate is 1:13~23, the ketotifen fumarate solution is vacuum filtered and crystallized at 0~5°C, and the crystallized ketotifen fumarate is sent into a freeze-drying box and vacuumized for freezing Drying and freeze-drying are divided into three times. The first freeze-drying is controlled at ≤-40°C, and the control time is 6-8 hours....

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PUM

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Abstract

The invention discloses a ketotifen fumarate tablet which is prepared from the following components in parts by mass: 30 to 50 parts of ketotifen fumarate, 5 to 12 parts of hydroxy propyl cellulose, 1to 3 parts of magnesium stearate and 1 to 2 parts of starch. According to the invention, ketotifen fumarate is pretreated in a low-temperature environment, so that the risk of a heat source in the ketotifen fumarate raw material is reduced; in the later preparation process, low-temperature preparation is continuously adopted so as to further eradicate the possibility of existence of a heat source. And the ketotifen fumarate tablet has a good effect in treating allergic asthma and allergic rhinitis and asthma syndrome.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a ketotifen fumarate tablet and an application 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, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/36A61K47/12A61K31/4535A61P11/06A61P11/02A61P37/08
CPCA61K9/2013A61K9/2054A61K9/2059A61K9/2095A61K31/4535A61P11/02A61P11/06A61P37/08
Inventor 林凡儒聂昌盛王丽娟王玉栋王明涛
Owner 仁和堂药业有限公司
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