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Preparation method of bepotastine besilate tablets

A technology of bepotastine bepotastine tablets and heat-melt production, which is applied in the field of medicine, can solve the problems of instability of bepotastine bepotastine to humidity, etc., and achieve the effects of ensuring product quality, facilitating sample stability, and simple process

Inactive Publication Date: 2018-05-22
JIANGSU LIANHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The patent reports that bepotastine besilate is unstable to humidity and easily produces optical isomers. Therefore, it is necessary to pay attention to the influence of excipient moisture on drug stability when developing oral solid preparations

Method used

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  • Preparation method of bepotastine besilate tablets
  • Preparation method of bepotastine besilate tablets
  • Preparation method of bepotastine besilate tablets

Examples

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Embodiment 1

[0018] The prescription components (parts by weight) of the bensulfobestatine tablet of the present application are: 10 parts by weight benzylbepotastine, 8-16 parts of microcrystalline cellulose, 80-92 parts of mannitol, polyethylene 5-15 parts of diol, 0-2 parts of magnesium stearate.

[0019] A typical benzenesulfobestatine tablet has the following components in parts by weight: 10 parts benzenesulfobestatine, 90 parts mannitol, 10 parts polyethylene glycol, 12 parts microcrystalline cellulose, and stearin 1.5 parts of magnesium acid. The preparation method of the benzenesulfobestatine tablet: weigh the benzenesulfobestatine, mannitol and polyethylene glycol in the above proportions, mix them uniformly, and granulate; after the granulation is completed, add microcrystalline cellulose 12 And 1.5 parts of magnesium stearate, mix well, press tablets, and coat to obtain the finished product.

[0020] Among them, three methods of hot melt shear granulation, hot melt extrusion granu...

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Abstract

The invention discloses a preparation method of bepotastine besilate tablets. The bepotastine besilate tablets are molded in one step by adopting a hot melting granulation method. The preparation method of the bepotastine besilate tablets, disclosed by the invention, one-step molding is realized by adopting the hot melting granulation method and the preparation method has the advantages of simpletechnology and short heating time; a sample is more easily stabilized and the quality of a product is ensured. Compared with an existing product, three different granulation methods are adopted, so that the effect of an additional auxiliary agent, i.e., a disintegrating agent, is more easily expressed; the disintegrating agent can be corroded and also can be partially disintegrated; products withdissolution similar with an original product can be produced and the preparation method has very good practicability.

Description

Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a preparation method of a bepotastine besilate tablet. Background technique [0002] Bepotastine is a commonly used anti-allergic drug. Its main indications are allergic rhinitis, urticaria, and itching caused by skin diseases (including eczema, dermatitis, prurigo, and pruritus). In the existing besilbepotastine tablets, the auxiliary materials used include D-mannitol, microcrystalline cellulose, polyethylene glycol 6000, magnesium stearate, hypromellose, and talc. Obviously, the pharmaceutical excipients have complex components, high manufacturing process difficulty, and increased production costs. Patients after taking the drug will also have a certain risk of side effects. [0003] In Chinese patent application CN106309389A, a benzene sulbestatin composition and preparations thereof are disclosed. The composition is composed of benzene sulbestatine, mannitol and solid p...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/4545A61K47/38A61P37/08
CPCA61K9/2054A61K31/4545
Inventor 朱丽褚青松
Owner JIANGSU LIANHUAN PHARMA
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