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Epinastine hydrochloride composition

A technology of epinastine hydrochloride and composition, which is applied in the field of epinastine hydrochloride composition, can solve problems such as difficulty in obtaining uniform mixing, increased difficulty in granulation, unfavorable preparation production, etc., and achieves reducing particle size distribution range, improving Compliance, low cost effect

Inactive Publication Date: 2016-06-29
重庆瑞泊莱医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Epinastine hydrochloride tastes extremely bitter after being dissolved in water, and it is difficult for a single flavoring agent to cover up its bitter taste, and after a large amount of flavoring agent is used, it increases the difficulty of granulation, and it is difficult to obtain uniform mixing and narrow particle size distribution. The particles are not conducive to the production of preparations

Method used

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  • Epinastine hydrochloride composition
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  • Epinastine hydrochloride composition

Examples

Experimental program
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Effect test

Embodiment 1

[0045] The composition prescription of fine granule described in the present embodiment is as follows:

[0046] Epinastine Hydrochloride 100g

[0047] Sucrose 9438g

[0048] Aspartame 320g

[0049] Sucralose 40g

[0050] Monoamine Glycyrrhizinate S40g

[0051] Hydroxypropyl Cellulose 42g

[0052] Strawberry essence 20g.

[0053] Firstly, the described epinastine hydrochloride, sucrose, aspartame, sucralose, and monoamine glycyrrhizinate S are respectively passed through a 120 mesh sieve, and are set aside; then the prescribed amount of epinastine hydrochloride and sucrose aspartame Add tannin, sucralose, and monoamine glycyrrhizinate S into the wet granulator, start stirring for 5 minutes until all materials are fully mixed and evenly distributed. Then add 600 g of 5% (w / w) hydroxypropyl cellulose aqueous solution as a binder for granulation. Fluidized bed drying until the water content is less than 3%, sizing with a sieve with a sieve aperture of 0.5mm. Spray 600g of ...

Embodiment 2

[0055] The composition prescription of fine granule described in the present embodiment is as follows:

[0056] Epinastine Hydrochloride 100g

[0057] Erythritol 9438g

[0058] Aspartame 320g

[0059] Sucralose 40g

[0060] Monoamine Glycyrrhizinate S40g

[0061] Hydroxypropyl Cellulose 42g

[0062] 20g of milk essence;

[0063] First described epinastine hydrochloride, erythritol, aspartame, sucralose, glycyrrhizic acid monoamine S are respectively passed through 120 mesh sieves, for subsequent use; then the epinastine hydrochloride and sucrose Put aspartame, sucralose, and monoamine glycyrrhizinate S into the wet granulator, and start stirring for 5 minutes until all materials are fully mixed and uniform. Then add 600 g of 5% (w / w) hydroxypropyl cellulose aqueous solution as a binder for granulation. Fluidized bed drying until the water content is less than 3%, sizing with a sieve with a sieve aperture of 0.5mm. Spray 600g of 2% (w / w) hydroxypropyl cellulose aqueous ...

Embodiment 3

[0065] The composition prescription of fine granule described in the present embodiment is as follows:

[0066] Epinastine Hydrochloride 100g

[0067] Erythritol 4438g

[0068] Sucrose 5000g

[0069] Aspartame 320g

[0070] Sucralose 40g

[0071] Monoamine Glycyrrhizinate S40g

[0072] Hydroxypropyl Cellulose 42g

[0073] 20g pineapple essence;

[0074]First described epinastine hydrochloride, erythritol, sucrose, aspartame, sucralose, glycyrrhizic acid monoamine S are passed through 120 mesh sieves respectively, for subsequent use; Then the epinastine hydrochloride of prescription quantity Put it into the wet granulator with sucrose aspartame, sucralose, and monoamine glycyrrhizinate S, and start stirring for 5 minutes until all materials are fully mixed evenly. Then add 600 g of 5% (w / w) hydroxypropyl cellulose aqueous solution as a binder for granulation. Fluidized bed drying until the water content is less than 3%, sizing with a sieve with a sieve aperture of 0.5mm...

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Abstract

The invention discloses an epinastine hydrochloride composition. In terms of 1000 weight parts, the prescription of the composition involves 15-50 parts by weight of epinastine hydrochloride, 830-950 parts by weight of filler, 25-60 parts by weight of a composite flavoring agent, 0.5-5 parts by weight of hydroxypropyl cellulose, 0.5-5 parts by weight of essence. The invention adopts the composite flavoring agent for taste modifying, also selects the filler with sweet taste, and is supplemented by essence, effectively covers up the disadvantage of extremely bitter taste of epinastine hydrochloride, and improves the clinical medication compliance. The invention effectively solves the problems of large particle size distribution and much particle fine powder in epinastine hydrochloride composition, can obtain stable and uniform particles, and is suitable for industrial production requirements.

Description

technical field [0001] The invention relates to epinastine, in particular to an epinastine hydrochloride composition. Background technique [0002] Epinastine hydrochloride is a highly selective H 1 Receptor inhibitors, since its tablets were launched in the Japanese market in 1994, due to its good effect, high safety, wide range of indications, few drug interactions and low cardiotoxicity, it has been the mainstay of Japanese oral antiallergic drugs. The leading products, capsules, eye drops and other dosage forms have been developed and launched one after another. [0003] Epinastine hydrochloride tastes extremely bitter, so it is mostly coated tablets or capsules clinically. Because this product has few side effects, low toxicity, and good patient tolerance, 1% hydrochloric acid was developed in Japan for pediatrics or specific patients. Epinastine dry syrup, which was approved for production in Japan in January 2005, is a new dosage form specially developed for pediatr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/55A61K9/16A61P37/08
Inventor 陈向李锋鲁定国梁玉勤
Owner 重庆瑞泊莱医药科技有限公司
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