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Ketotifen fumarate tablet and preparation process 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 reduce the risk of heat source and eliminate the possibility of heat source Effect

Inactive Publication Date: 2020-03-24
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 discloses a ketotifen fumarate tablet comprising the following components, by mass: 40 to 90 parts of ketotifen fumarate, 7 to 18 parts of hydroxy propyl cellulose, 1 to 5 parts of magnesium stearate and 1 to 2 parts of starch. Meanwhile, the invention also discloses a preparation method of the ketotifen fumarate tablet. According to the invention, ketotifen fumarate is pretreated ina low-temperature environment, so that the risk of a heat source in the ketotifen fumarate raw material is reduced; and low-temperature preparation is continuously adopted in the later preparation process to eliminate the possibility of existence of the heat source.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to ketotifen fumarate tablets and a preparation process 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 ha...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/38A61K47/36A61K31/4535A61P11/06A61P11/02A61P37/08
CPCA61K9/2054A61K9/2059A61K9/2095A61K31/4535A61P11/02A61P11/06A61P37/08
Inventor 孙运玲郭增光王美成刘倩
Owner 仁和堂药业有限公司
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