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Emedastine difumarate sustained release tablets and preparation method thereof

A technology for emedastine fumarate and sustained-release tablets, which can be applied to pharmaceutical formulations, medical preparations containing active ingredients, respiratory diseases, etc. Issues such as poor finish and insufficient hardness on one side of the release tablet

Inactive Publication Date: 2011-04-20
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The emedastine fumarate sustained-release tablets prepared by this method have problems such as poor surface finish, insufficient hardness, and unstable release rate.

Method used

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  • Emedastine difumarate sustained release tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Weigh 2 mg of emedastine fumarate, 40 mg of carbopol resin, 75 mg of povidone K30, and 50 mg of cyclodextrin.

[0031] a. First mix emedastine fumarate and carbopol resin according to the method of equal addition, and set aside;

[0032] b. After mixing the above mixture with povidone K30, add a little 95% ethanol, stir to dissolve it, and set aside;

[0033] c. Then add cyclodextrin to make soft material, granulate with 20 mesh, and dry at 70°C;

[0034] d, granulation: Add appropriate amount of magnesium stearate to the dry granules, mix evenly, sieve and granulate;

[0035] e. Tablet compression Calculate the tablet weight according to the determined content of emedastine fumarate granules, determine the tablet weight range, and press the tablet with a die.

Embodiment 2

[0037] Weigh 2 mg of emedastine fumarate, 40 mg of carbopol resin, 75 mg of povidone K30, and 50 mg of cyclodextrin.

[0038] a. Mix emedastine fumarate and carbopol resin according to the method of equal addition and set aside.

[0039] b. After mixing the above mixture with povidone K30, add 75% ethanol and stir to dissolve it, set aside;

[0040] c. Add cyclodextrin to make soft material, granulate with 20 mesh, and dry at 50°C.

[0041] d. Grain sizing Add an appropriate amount of magnesium stearate (based on its non-sticky punch) to the dry granules, mix evenly, and sieve through a 24-mesh sieve for sizing.

[0042] e, tabletting Calculate the tablet weight according to the measured emedastine fumarate granule content, determine the tablet weight range, use 6.5mm die pressing tablet.

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Abstract

The invention discloses emedastine difumarate sustained release tablets, which are prepared from the following raw materials by weight: 2mg of emedastine difumarate, 40mg of carbopol resin, 75mg of povidone K30 and 50mg of cyclodextrine. The preparation method comprises the following steps of: a, mixing the emedastine difumarate and the carbopol resin according to an equivalent incrementing method; b, mixing the mixture and the povidone K30, adding ethanol and stirring for dissolution; c, adding the cyclodextrine to prepare a soft material, preparing granules with the granularity of 20 meshes, and drying at the temperature of between 50 and 70 DEG C; d, processing the granules; and e, tabletting. By taking the carbopol resin, the povidone K30 and the cyclodextrine as framework materials and by adopting the wet-process pelletizing and tabletting technology, the emedastine difumarate sustained release tablets are smooth in surfaces, good in hardness and high in release stability and do not fall off in the coating process.

Description

technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to an emedastine fumarate sustained-release tablet and a preparation method thereof. Background technique [0002] Emedastine fumarate is a second-generation histamine H1 receptor antagonist with specific affinity for H1 receptors. Clinically, it is mainly used for the treatment of allergic rhinitis and chronic urticaria. Compared with similar drugs, emedastine fumarate has the characteristics of high curative effect, less side effects, good tolerance, no cardiotoxicity, etc., especially small central sedative effect, no drowsiness and other side effects after use, so it is favored by the drug Patients welcome. Emedastine fumarate oral preparations currently clinically used mainly include capsules and emedastine fumarate sustained-release tablets. Because the sustained-release tablet can enable the active ingredients of the drug to release the drug quantitatively wit...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/551A61K47/40A61P37/08A61P11/02A61P17/00
Inventor 刘书睿路玉锋王志良赵霞
Owner NORTH CHINA PHARMA COMPANY
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