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Preparation method of ketotifen fumarate oral solution

A technology of ketotifen fumarate and oral solution, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problem of impurity content of ketotifen fumarate oral solution. control, low impurity content, etc.

Active Publication Date: 2020-07-28
武汉贝参药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And the impurity content is uncontrollable in the ketotifen fumarate oral solution that existing method prepares; Therefore it is necessary to develop a kind of preparation method of the low ketotifen fumarate oral solution of impurity content

Method used

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  • Preparation method of ketotifen fumarate oral solution
  • Preparation method of ketotifen fumarate oral solution
  • Preparation method of ketotifen fumarate oral solution

Examples

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Embodiment 1

[0033] The present embodiment provides a kind of preparation method of ketotifen fumarate oral solution, comprises the steps:

[0034] Step 1. Add water into a closed container, under the pressure of 0.12MPa, temperature of 37°C and stirring, successively add 99.5 parts of citric acid, 136 parts of disodium hydrogen phosphate, and 13.5 parts of ketotifen fumarate, The airtight container is equipped with an ultrasonic instrument, and the ultrasonic instrument is turned on for ultrasonication. The ultrasonic frequency is 13KHz, and the ultrasonic time is 8min to obtain solution I;

[0035] Step 2. Add 0.04 L of co-solvent into another container, under stirring condition, add 15 parts of methyl p-hydroxybenzoate and 10 parts of propyl p-hydroxybenzoate in batches, stir and dissolve to obtain solution II;

[0036] Step 3. Add the solution II to the solution I, and continue to stir evenly; add 12.5 parts of sucrose and 15,000 parts of sorbitol while stirring until the solution is c...

Embodiment 2

[0039] This embodiment provides a preparation method of ketotifen fumarate oral solution, except that the temperature in step 1 is replaced by 35°C, the rest are the same as in embodiment 1; specifically:

[0040] Step 1. Add water into a closed container, under the pressure of 0.12MPa, temperature of 35°C and stirring, successively add 99.5 parts of citric acid, 136 parts of disodium hydrogen phosphate, and 13.5 parts of ketotifen fumarate, The airtight container is equipped with an ultrasonic instrument, and the ultrasonic instrument is turned on for ultrasonication. The ultrasonic frequency is 13KHz, and the ultrasonic time is 8min to obtain solution I;

[0041] Step 2. Add 0.04 L of co-solvent into another container, under stirring condition, add 15 parts of methyl p-hydroxybenzoate and 10 parts of propyl p-hydroxybenzoate in batches, stir and dissolve to obtain solution II;

[0042] Step 3. Add the solution II to the solution I, and continue to stir evenly; add 12.5 parts...

Embodiment 3

[0045] This embodiment provides a preparation method of ketotifen fumarate oral solution, except that the temperature in step 1 is replaced by 40°C, the rest are the same as in embodiment 1; specifically:

[0046]Step 1. Add water into a closed container. Under the pressure of 0.12MPa, temperature of 40°C and stirring, successively add 99.5 parts of citric acid, 136 parts of disodium hydrogen phosphate, and 13.5 parts of ketotifen fumarate. The airtight container is equipped with an ultrasonic instrument, and the ultrasonic instrument is turned on for ultrasonication. The ultrasonic frequency is 13KHz, and the ultrasonic time is 8min to obtain solution I;

[0047] Step 2. Add 0.04 L of co-solvent into another container, under stirring condition, add 15 parts of methyl p-hydroxybenzoate and 10 parts of propyl p-hydroxybenzoate in batches, stir and dissolve to obtain solution II;

[0048] Step 3. Add the solution II to the solution I, and continue to stir evenly; add 12.5 parts ...

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Abstract

The present invention discloses a preparation method of a ketotifen fumarate oral solution. The method comprises the following steps: adding water into a closed container at a pressure of 0.10 MPa-0.15 MPa and a temperature of 35-40 DEG C, adding citric acid, disodium hydrogen phosphate and ketotifen fumarate under stirring condition, arranging an ultrasonic instrument in the closed container, andturning on the ultrasonic instrument to perform ultrasound at an ultrasonic frequency of 12 KHz-15 KHz and ultrasonic time of 6-10 min to obtain a solution I; adding a co-solvent to another container, adding methyl p-hydroxybenzoate and propyl p-hydroxybenzoate under stirring conditions, and conducting stirring and dissolving to obtain a solution II; adding the solution II to the solution I to bestirred evenly; adding sucrose and sorbitol while stirring until the solution is completely dissolved to obtain a solution III; and adding essence to the solution III, adding water to a constant volume, and conducting stirring and still putting until no bubbles exists. The obtained ketotifen fumarate oral solution prepared by the method has low impurity content.

Description

technical field [0001] The invention relates to the technical field of preparation of oral solutions, in particular to a preparation method of ketotifen fumarate oral solution. Background technique [0002] Ketotifen fumarate has both histamine H1 receptor antagonism and the release of allergic reaction mediators. It not only has strong anti-allergic effect, but also has a long duration of drug effect. The curative effect on asthma is better than that on endogenous asthma. This strain is a new type of oral medicine for the prevention and treatment of bronchial asthma. For mental patients, especially the elderly and children, the oral compliance of ordinary tablets is poor and the onset of action is slow. Existing ketotifen fumarate is usually in the form of tablets or capsules. It is very necessary to develop an oral solution formulation that can be taken anytime and anywhere and has a rapid effect without taking it with water. However, the impurity content in the ketotife...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4535A61K47/12A61K47/02A61P37/08A61P11/06
CPCA61K31/4535A61K9/0095A61K47/12A61K47/02A61P37/08A61P11/06
Inventor 董枭卢军熊齐春
Owner 武汉贝参药业股份有限公司
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