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Ebastine oral liquid preparation and preparation method thereof

An ebastine oral liquid and the technology of ebastine, applied in the direction of medical formula, medical preparations with no active ingredients, medical preparations containing active ingredients, etc., can solve the problems of ebastine not being easy to dissolve, It achieves the effects of wide applicable population, complete and comprehensive efficacy, and convenient and simple use

Inactive Publication Date: 2016-06-22
HANGZHOU ZIQUAN BIOPHARMATEC CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The second object of the present invention is to provide a kind of preparation method of described ebastine oral liquid preparation, this preparation method has the advantages such as method is simple, easy to operate, by adding the mode of latent solvent and solubilizing agent to improve ebastine Improve the solubility of ebastine in the solution, realize the preparation of higher concentration ebastine oral solution, and overcome the problem that ebastine itself is not easily soluble

Method used

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  • Ebastine oral liquid preparation and preparation method thereof
  • Ebastine oral liquid preparation and preparation method thereof
  • Ebastine oral liquid preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The formula of ebastine oral liquid preparation is shown in Table 1 below:

[0028] Take every 10L ebastine oral solution (100 bottles of quality) as a batch of products for batching:

[0029] Table 1 raw material consumption

[0030] Unit: g

[0031]

[0032] The preparation method of ebastine oral liquid preparation is as follows:

[0033] Put polyoxyethylene hydrogenated castor oil, glycerin and lactic acid into a stirring pot, add an appropriate amount of water and mix well, then add ebastine, sorbitol, neohesperidin dihydrochalcone, and orange flavor to the stirring pot And the p-hydroxyphenylpropionate continues to stir and dissolve, then add methyl silicone oil to defoam, add water to make up 10L, adjust the pH value to between 4-5 with sodium hydroxide, filter for clarification, quality inspection, and fill into finished products. Sales can be formed.

Embodiment 2

[0035] The formula of ebastine oral liquid preparation is shown in Table 2 below:

[0036] Take every 10L ebastine oral solution (100 bottles of quality) as a batch of products for batching:

[0037] Table 2 raw material consumption

[0038] Unit: g

[0039]

[0040] The preparation method of ebastine oral liquid preparation is as follows:

[0041] Put caprylic capric acid polyethylene glycol glycerin, ethanol and citric acid into a stirring pot and add appropriate amount of water to mix and stir evenly. The stirring speed is adjusted to 50-100rad / min. Add ebastine, mannitol, xylitol, orange essence and paraben to the pot and continue stirring to dissolve. Adjust the stirring rate to 80-150rad / min, then add methyl silicone oil to defoam, and add water to make up 10L, adjust the pH value to 4-5 with sodium hydroxide, filter for clarification, quality inspection, and fill into finished products, which can be sold.

Embodiment 3

[0043] The formula of ebastine oral liquid preparation is shown in Table 3 below:

[0044] Take every 10L ebastine oral solution (100 bottles of quality) as a batch of products for batching:

[0045] Table 3 raw material consumption

[0046] Unit: g

[0047]

[0048] The preparation method of ebastine oral liquid preparation is as follows:

[0049] Put Tween 80, ethanol and citric acid into a stirring pot and add 1 / 2-3 / 4 of the total water quality, mix and stir evenly, adjust the stirring speed to 50-100rad / min, and the stirring temperature is at room temperature That’s it, add ebastine, mannitol, xylitol, orange essence and p-hydroxyphenylpropionate to the stirring pot and continue to stir and dissolve, adjust the stirring speed to 80-150rad / min, then add methyl Silicone oil defoaming, add water to make up 10L, adjust the pH value to 4-5 with sodium hydroxide, filter for clarification, quality inspection, and fill into finished products, which can be sold.

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Abstract

The invention provides an ebastine oral liquid preparation. The ebastine oral liquid preparation is mainly prepared from, by mass, 8-12 parts of ebastine, 90-120 parts of solubilizer, 0.8-2 parts of aromatic, 650-800 parts of sweetening agent, 1-4 parts of preservative, 0.8-2 parts of antifoaming agent, 2,000-3,000 parts of latent solvent, pH modifier adjusting pH to be 4-5 and a proper amount of water. The preparing method comprises the steps that solubilizer, latent solvent and a part of pH modifier are mixed and then water is added and stirred until the mixture is dissolved, then, ebastine, sweetening agent, aromatic and preservative are added and continue to be stirred until all the materials are dissolved, antifoaming agent and water are added, the residual pH modifier is added to adjust the pH value to be 4-5, and filtering, quality detecting and filling are added. The ebastine oral liquid preparation is absorbed by the human body easily, and is convenient to carry, wide in target user range and convenient to use.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparation processing, in particular to an ebastine oral liquid preparation and a preparation method thereof. Background technique [0002] Ebastine is a peripheral histamine H1 receptor antagonist. It is often used for allergic rhinitis (seasonal and perennial), idiopathic chronic urticaria with or without allergic conjunctivitis. Ebastine is a white crystal or crystalline powder, odorless and tasteless, with a melting point of 84-87°C, easily soluble in acetic acid, soluble in methanol, insoluble in water, unstable under light, and gradually turns into a light yellow substance. [0003] The currently marketed preparation containing ebastine is ebastine tablet, with ebastine as the active ingredient, and the content of each tablet is 0.01g. In addition to tablets, there are also ebastine orally disintegrating tablets, dispersible tablets, inhalants, transdermal preparations and other dosage forms...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/02A61K47/12A61K47/10A61K47/26A61K47/44A61K47/14A61K47/34A61K31/445A61P37/08
CPCA61K9/0053A61K9/08A61K31/445A61K47/02A61K47/10A61K47/12A61K47/14A61K47/26A61K47/34A61K47/44
Inventor 潘正茂胡秀波谢齐昂张莉华刘东华
Owner HANGZHOU ZIQUAN BIOPHARMATEC CO LTD
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