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Emedastine difumarate sustained release tablets and preparation method thereof

A technology of emedastine fumarate and sustained-release tablets, which is applied in the fields of pharmaceutical formulas, medical preparations containing active ingredients, respiratory diseases, etc., and can solve the problems of insufficient hardness, unstable release Problems such as poor smoothness of one side of Sting sustained-release tablets

Inactive Publication Date: 2012-02-29
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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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Weigh 2 mg of emestine fumarate, 40 mg of kappopol resin, 75 mg of povidone K, and 50 mg of cyclodextrin.

[0031] a. First, mix emestine fumarate and carbopoietic resin according to an equal amount of incremental addition, for use;

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

[0033] c. Add cyclodextrin again to make soft material, granulate with 20 meshes, and dry at 70°C;

[0034] d. Granulation Add an appropriate amount of magnesium stearate to the dry granules, mix well, sieve and granulate;

[0035] e. Tablet Compression Calculate the tablet weight according to the measured content of emestine fumarate particles, determine the tablet weight range, and press the tablet with a die.

Embodiment 2

[0037] Weigh 2 mg of emestine fumarate, 40 mg of kappopol resin, 75 mg of povidone K, and 50 mg of cyclodextrin.

[0038] a. Mix emestine fumarate and carbopoietic resin according to an equal amount of incremental addition, and set aside.

[0039] B, after the above mixture is mixed with povidone K30, add 75% ethanol and stir to dissolve it, for subsequent use;

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

[0041] d. Granulation Add an appropriate amount of magnesium stearate to the dry granules (whichever is not sticky), mix well, and granulate with a 24-mesh sieve.

[0042] e. Tablet weight is calculated according to the measured content of emestine fumarate granules, and the range of tablet weight is determined, using 6.5mm die pressing.

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PUM

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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 emestine fumarate sustained-release tablets and a preparation method thereof. Background technique [0002] Emestine 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, emestine fumarate has the characteristics of high curative effect, few side effects, good tolerance, no cardiotoxicity, especially small central sedative effect, and no side effects such as drowsiness after use, so it is widely used in the drug. Patient welcome. At present, the oral preparations of emestine fumarate in clinical use mainly include capsules and emestine fumarate sustained-release tablets. Because the sustained-release tablet enables the active ingredients of the drug to be quantitatively released in the gastroin...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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