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Stable solution containing epinastine or hydrochloride of epinastine

A technology of epilastine and hydrochloride, applied in the field of medical technology preparation, can solve the problems of solution turbidity, reduced curative effect, poor taste, etc., and achieves the effects of easy acceptance, guaranteed safety, and accurate dosage

Inactive Publication Date: 2013-07-31
BEIJING KEYUAN CHUANGXIN TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Compared with my country, Japan has made great progress in the treatment of children's allergic diseases. In March 2005, Japan approved epinastine hydrochloride granules for children with allergic rhinitis, rubella and itching caused by skin diseases (including eczema). ), etc., the preparation is suitable for children, but the preparation is a solid preparation, and the taste is not ideal, and the compliance of children's medication is not ideal
In addition, the dosage of the preparation is 0.25-0.5 mg epinastine hydrochloride per kilogram of body weight per day, and the accuracy of the dosage is difficult to control.
[0007] Because epinastine and its hydrochloride are prone to chemical degradation in water, it will reduce the curative effect and increase the toxicity and side effects, and molecular aggregation may occur, making the solution turbid
In addition, epinastine and its hydrochloride have certain irritation, and the mouthfeel of the solution preparation is poor, which is difficult to be accepted by patients
Therefore, the preparation of the oral solution preparation of epinastine or its hydrochloride also has certain difficulty technically

Method used

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  • Stable solution containing epinastine or hydrochloride of epinastine
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  • Stable solution containing epinastine or hydrochloride of epinastine

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] formula:

[0030]

[0031] Preparation: Take the raw and auxiliary materials according to the formula, take an appropriate amount of distilled water, stir to dissolve, and adjust the pH with citric acid-sodium citrate buffer solution (take 30g of sodium citrate, add 200ml of water, and adjust the pH value to 5.5±0.2 with sodium hydroxide) When the value reaches 3.0-4.0, add distilled water to dilute to the full amount, filter with a 0.45 μm microporous membrane, fill, stopper, and cap.

Embodiment 2

[0033] formula:

[0034]

[0035] Preparation: Take the raw and auxiliary materials according to the formula, take an appropriate amount of distilled water, stir to dissolve, and adjust the pH with citric acid-sodium citrate buffer solution (take 30g of sodium citrate, add 200ml of water, and adjust the pH value to 5.5±0.2 with sodium hydroxide) When the value reaches 3.0-4.0, add distilled water to dilute to the full amount, filter with a 0.45 μm microporous membrane, fill, stopper, and cap.

Embodiment 3

[0037] formula:

[0038]

[0039] Preparation: Take the raw and auxiliary materials according to the formula, take an appropriate amount of distilled water, stir to dissolve, and adjust the pH with citric acid-sodium citrate buffer solution (take 30g of sodium citrate, add 200ml of water, and adjust the pH value to 5.5±0.2 with sodium hydroxide) When the value reaches 3.0-4.0, add distilled water to dilute to the full amount, filter with a 0.45 μm microporous membrane, fill, stopper, and cap.

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PUM

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Abstract

The invention discloses a stable liquid medicine composition containing epinastine or hydrochloride of epinastine. 1000ml of the liquid medicine composition mainly comprises 0.1-10.0g of epinastine or hydrochloride of epinastine, 10-50g of polyethylene pyrrolidone and 5-100ml of polyethylene glycol 400. Meanwhile, the invention discloses a preparation method of the liquid medicine composition, wherein pH of liquid is controlled to be 4.5-6.5. The liquid medicine composition can also be taken as a medicine which urgently needs to be developed in clinic and has an excellent effect on allergic reaction diseases of children.

Description

technical field [0001] The invention belongs to the field of medical technology preparation, and in particular relates to a pharmaceutical composition containing epinastine or its hydrochloride, especially a solution suitable for oral administration by children. Background technique [0002] Epinastine is as shown in the following structural formula (I): [0003] [0004] Structural formula (I) It is chemically known as 3-amino-9,13b-dihydro-1H-dibenzo[c,f]imidazo[1,5-a]azepine hydrochloride. It is reported that a series of substances, including epinastine or its hydrochloride, have highly selective affinity for H1 receptors, and have strong antagonistic effects on histamine, leukotriene C4, PAF, serotonin, etc. And can inhibit the release of chemical mediators such as histamine and SRS-A (slow reacting substance A). [0005] The solution composition involved in the present invention is clinically used for the treatment of children's allergic rhinitis, rubella and pruri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/55A61K47/34A61P37/08A61P11/02A61P17/00A61K47/10A61K47/32
Inventor 李晓红
Owner BEIJING KEYUAN CHUANGXIN TECH
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