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A kind of tablet of bepotastine besilate and preparation method thereof

A technology of bepotastine bepotastine and tablets, which is applied in the field of tablets and preparations of bepotastine bepotastine, can solve the problems of limited production capacity, high equipment requirements, high equipment cost, etc., and achieve tablet weight Stable, low safety risk, smooth surface effect

Active Publication Date: 2020-07-17
NANJING HEALTHNICE MEDICAL TECH +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Tablets prepared by this patent have slow dissolution behavior in different media without obvious disintegration process
In addition, in this patent, PEG6000 is used as a binder, and the process is a hot-melt granulation process. This process requires high equipment, high equipment cost, and limited production capacity.

Method used

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  • A kind of tablet of bepotastine besilate and preparation method thereof
  • A kind of tablet of bepotastine besilate and preparation method thereof
  • A kind of tablet of bepotastine besilate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Tablet prescription (1000 formulation units):

[0035]

[0036]

[0037] The preparation method of the present invention comprises the following steps:

[0038] (1) Pretreatment: sieve the active ingredients and auxiliary materials for later use;

[0039] (2) Premixing: mixing the active ingredient with the filler and PEG6000;

[0040] (3) Granulation: add binder solution to make soft material, 20-30 mesh granulation;

[0041] (4) Drying and sizing: drying the granules obtained in step (3) at 50°C until the water content of the granules is no higher than 3%, and then making 20-30 mesh granules;

[0042] (5) Total blending: add anti-sticking agent and lubricant to the granulated granules, and detect the intermediate after mixing;

[0043] (6) Tablet compression: According to the results of intermediate detection, calculate the weight of the tablet, press the tablet to make a tablet core, and control the tablet hardness to 40-80N;

[0044] (7) Coating: the table...

Embodiment 2

[0046] Tablet prescription (1000 formulation units):

[0047]

[0048] The preparation method of the present invention comprises the following steps:

[0049] (1) Pretreatment: sieve the active ingredients and auxiliary materials for later use;

[0050] (2) Premixing: mixing the active ingredient with the filler and PEG6000;

[0051] (3) Granulation: add binder solution to make soft material, 20-30 mesh granulation;

[0052] (4) Drying and sizing: drying the granules obtained in step (3) at 50°C until the water content of the granules is no higher than 3%, and then making 20-30 mesh granules;

[0053] (5) Total blending: add anti-sticking agent and lubricant to the granulated granules, and detect the intermediate after mixing;

[0054] (6) Tablet compression: according to the results of intermediate detection, calculate the weight of the tablet, press the tablet to make a tablet core, and control the tablet hardness to 40-80N;

[0055] (7) Coating: the tablet core is co...

Embodiment 3

[0104] Embodiment 3: Effect verification (each inspection item can be carried out with reference to the fourth part of the Chinese Pharmacopoeia of the 2015 edition)

[0105] 1. Test the fluidity and compressibility of the intermediate particles of the examples and comparative examples, and the specific results are shown in Table 1

[0106] Table 1 Example sample intermediate particle fluidity, compressibility and hygroscopicity testing results

[0107]

[0108] 2, detect the content uniformity (general rule 0941) of embodiment and comparative example sample, concrete result is shown in Table 2

[0109] Table 2 embodiment sample content uniformity detection result

[0110]

[0111]

[0112] 3. The friability (general rule 0941) and hardness of samples (plain slices) of detection examples and comparative examples, the specific results are shown in Table 3

[0113] Table 3 embodiment sample friability and hardness testing results

[0114] sample Friability...

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Abstract

The invention relates to a bepotastine besilate tablet and a preparation method thereof, and belongs to the technical field of medicament. The bepotastine besilate tablet is mainly prepared from the following components in parts by weight: 5 to 10 parts of bepotastine besilate, 50 to 90 parts of mannitol, 6 to 12 parts of PEG (Polyethylene Glycol) 6000, 0.2 to 2 parts of hydroxypropyl methyl cellulose, 5 to 10 parts of microcrystalline cellulose and 1 to 3 parts of magnesium stearate. The preparation method is characterized by during a preparation process, firstly, mixing active components, afilling agent and an adhesive, and then adding an adhesive solution prepared from the adhesive and water, thus preparing a soft material; secondly, pelleting; finally, carrying out tabletting and coating on granules with an anti-adhesion agent and a lubricating agent. A preparation technology comprises the following steps of pretreatment of auxiliary materials, mixing, wet granulation, drying, grain finishing, total mixing, tabletting and coating. The bepotastine besilate tablet prepared by adopting the preparation method has good dissolubility and is stable in quality, simple in preparation technology and suitable for large-scale production.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a tablet of bepotastine besilate and a preparation method thereof. Background technique [0002] Bepotastine besilate is a drug with antihistamine activity. It has a selective inhibitory effect on histamine H1 receptors, has no affinity for 5-HT2, α1, and α2, and can inhibit the tropism of allergic inflammation. The infiltration of eosinophils into the inflammatory site inhibits the production of IL-5 by activated eosinophils. Bepotastine besilate is used for the treatment of allergic rhinitis, urticaria, itching caused by skin diseases (eczema, dermatitis, prurigo, pruritus), nervous tinnitus. Bepotastine besilate rarely enters the brain, has no sedative effect, and has minimal adverse reactions. It has good efficacy and broad pharmaceutical prospects. [0003] Japanese patent JP3909998B2 obtains a relatively stable tablet of bepotastine bepotastine by optimizing ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/28A61K47/10A61K47/38A61K31/4545A61P37/08A61P11/02A61P17/00A61P17/04A61P27/16A61P25/02
CPCA61K9/2031A61K9/2054A61K9/28A61K31/4545
Inventor 石文晶辛妮王华娟
Owner NANJING HEALTHNICE MEDICAL TECH
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