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Stable bepotastine besilate tablet and preparation method thereof

A technology of betalastine tablets and stin tablets, which is applied in the directions of medical preparations, pharmaceutical formulations, and pills containing active ingredients, can solve problems such as affecting the stability of preparations, and achieve good stability, good dissolution, and The effect of easy process operation

Inactive Publication Date: 2017-01-04
BEIJING XINLINGXIAN MEDICAL TECH DEV CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These patents all use the wet method, which inevitably brings the drug into direct contact with water, thus affecting the stability of the formulation

Method used

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  • Stable bepotastine besilate tablet and preparation method thereof
  • Stable bepotastine besilate tablet and preparation method thereof
  • Stable bepotastine besilate tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Embodiment 1: preparation embodiment

[0017]

[0018] Preparation Process:

[0019] (1) Mix 73g of lactose, 28g of microcrystalline cellulose and 4g of hypromellose through an 80-mesh sieve, add an appropriate amount of water-based soft material, and granulate with a 24-mesh granulation to obtain blank granule 1;

[0020] (2) Mix the above-mentioned blank granules 1 with 10 g of bulk drug and 2 g of talcum powder evenly to obtain granules for tableting;

[0021] (3) Tablet pressing with tablet machine, weight 120mg, hardness 70-90N, coated with Opadry.

Embodiment 2

[0022] Embodiment 2: preparation embodiment

[0023]

[0024] Preparation Process:

[0025] (1) Mix 85g mannitol, 41g microcrystalline cellulose, and 5g croscarmellose sodium through an 80-mesh sieve, add an aqueous solution containing 3g hydroxypropyl cellulose to make a soft material, and granulate at 20 mesh to obtain a blank particle 1;

[0026] (2) Mix the above-mentioned blank granules 1 with 11g of bulk drug and 2g of magnesium stearate to obtain granules for tableting;

[0027] (3) Tablet pressing with tablet machine, weight 150mg, hardness 60-80N, coated with Opadry.

Embodiment 3

[0028] Embodiment 3: preparation embodiment

[0029]

[0030]

[0031] Preparation Process:

[0032] (1) Mix 70g of mannitol, 40g of microcrystalline cellulose, 10g of croscarmellose sodium and 5g of croscarmellose sodium through an 80-mesh sieve, add water to make a soft material, and granulate with a 24-mesh to obtain a blank particle 1;

[0033] (2) Mix the above-mentioned blank granule 1 with 9g of bulk drug and 2g of silicon dioxide to obtain granules for tableting;

[0034] (3) Tablet pressing with tablet machine, weight 140mg, hardness 70-90N, coated with Opadry.

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Abstract

The invention relates to a tablet containing bepotastine besilate or benzene sulfonate thereof and a preparation method of the tablet, and belongs to the technical field of pharmaceutical preparations. The tablet consists of the bepotastine besilate or the benzene sulfonate thereof, a diluent, an adhesive, a disintegrant and a lubricant; and the preparation method of the tablet containing the bepotastine besilate or the benzene sulfonate thereof comprises the following steps: 1) obtaining blank particles, specifically, uniformly mixing the diluent, the adhesive and / or the disintegrant, and adding proper amount of moistening agent and / or binding agent for performing granulation; 2) obtaining granules for tabletting, specifically, uniformly mixing the blank granules with crude drugs, the lubricant and / or the disintegrant; and 3) conducting compression molding, specifically, conducting compression molding on the granules for tabletting by virtue of proper equipment. The bepotastine besilate tablet prepared by the invention has the advantages of being good in repeatability, good in dissolution, good in drug stability, simple and convenient in technological operation and the like.

Description

technical field [0001] The invention relates to a bepotastine tablet, specifically, a tablet containing bepotastine or its besylate. The invention also relates to a preparation method of the bepotastine tablet, and the sample prepared by the method has the advantages of good reproducibility, good dissolution, good drug stability, simple process operation and the like. The invention belongs to the field of preparation technology. Background technique [0002] Bepotastine besilate is a potent and long-acting histamine H1 receptor antagonist, has no affinity for 5-HT2, α1, α2, and can inhibit eosinophils from moving to the inflammatory site during allergic inflammation Infiltration of activated eosinophils inhibits the production of IL-5. Bepotastine besilate is used for the treatment of allergic rhinitis, urticaria (eczema, dermatitis, pruritus, prurigo, skin disease) and pruritus, etc., and has a wide range of clinical applications. [0003] Bepotastine besilate is solid a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4545A61K9/20A61P37/08A61P11/02A61P17/00A61P17/04
Inventor 邓超张印平
Owner BEIJING XINLINGXIAN MEDICAL TECH DEV CO LTD
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