Ivabradine hydrochloride tablet and preparation method thereof

A technology of ivabradine hydrochloride and ivabradine hydrochloride, which is applied in the field of ivabradine hydrochloride tablets and its preparation, can solve the problems of complex preparation of ivabradine hydrochloride tablets, and achieve the effect of improving compliance

Inactive Publication Date: 2017-01-04
CISEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Just because the preparation of ivabrad...

Method used

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  • Ivabradine hydrochloride tablet and preparation method thereof
  • Ivabradine hydrochloride tablet and preparation method thereof
  • Ivabradine hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Embodiment 1: ivabradine hydrochloride sheet (10000)

[0013]

[0014]

[0015] Preparation method: Weigh the prescribed amount of PVPK 30 , dissolved in 50% ethanol solution, and used as a binder for subsequent use; weigh the ivabradine hydrochloride of the prescribed amount, and mix it with the equal amount of lactose of the prescribed amount; add the starch of the prescribed amount and mix evenly. Add binder, mix evenly, and pass through 20 mesh to granulate; dry the wet granules at 60°C, add prescription amount of magnesium stearate and micropowder silica gel, pass through 18 mesh for granulation, and mix evenly; check the particle content, and use the middle one according to the content Flat die-pressed tablet with score; film-coated tablet core, aluminum-plastic package, ready to use.

Embodiment 2

[0016] Embodiment 2: ivabradine hydrochloride sheet (10000)

[0017]

[0018] Preparation method: Weigh the prescribed amount of PVPK 30 , dissolved in 50% ethanol solution, and used as a binder for subsequent use; weigh the prescribed amount of ivabradine hydrochloride, and mix it with the prescribed amount of lactose; then add the prescribed amount of microcrystalline cellulose and mix evenly. Add binder, mix evenly, and pass through 20 mesh to granulate; dry the wet granules at 60°C, add prescription amount of magnesium stearate and micropowder silica gel, pass through 18 mesh for granulation, and mix evenly; check the particle content, and use the middle one according to the content Flat die-pressed tablet with score; film-coated tablet core, aluminum-plastic package, ready to use.

Embodiment 3

[0019] Embodiment 3: ivabradine hydrochloride sheet (10000)

[0020]

[0021] Preparation method: take the prescribed amount of PVPK30, dissolve it with 50% ethanol solution, and use it as an adhesive for later use; weigh the prescribed amount of ivabradine hydrochloride, and mix it with the prescribed amount of lactose; add the prescribed amount of Mix the pregelatinized starch well. Add binder, mix evenly, and pass through 20 mesh to granulate; dry the wet granules at 60°C, add prescription amount of magnesium stearate and micropowder silica gel, pass through 18 mesh for granulation, and mix evenly; check the particle content, and use the middle one according to the content Flat die-pressed tablet with score; film-coated tablet core, aluminum-plastic package, ready to use.

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PUM

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Abstract

The invention belongs to the technical field of medicine preparation, and relates to an ivabradine hydrochloride tablet and a preparation process thereof. A mark is formed in the ivabradine hydrochloride tablet, and two cracked tablets fulfill the dosage of 2.5+/-0.1mg after the tablet is torn according to the mark. The ivabradine hydrochloride tablet is prepared from ivabradine hydrochloride, lactose monohydrate, starch, PVPK30, aerosil and magnesium stearate. When a patient takes the tablet, the patient takes half tablet by tearing the tablet according to the mark so as to fulfill the dosage of 2.5mg, or takes the whole tablet to fulfill the dosage of 5mg, or takes one and a half tablets to fulfill the dosage of 7.5mg. Compared with the prior art, the ivabradine hydrochloride tablet and the preparation process have the advantages that a ivabradine hydrochloride tablet with small specification can meet the requirement of multiple usages and dosages, so that the patient compliance can be improved.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to an ivabradine hydrochloride tablet and a preparation process thereof. Background technique [0002] Ivabradine slows down the heart rate of rat models of chronic heart failure for a long time, and the change parameters of left ventricular function and structural tissue were measured after 3 days of drug withdrawal. According to the results, it is believed that long-term application of ivabradine can effectively improve the heart failure of animals. Left ventricular function and structure. The pure heart rate-reducing effect of ivabradine does not alter these parameters and preserves the composition of the wall thickening that facilitates cardiac pumping. Ivabradine can reduce the spontaneous beating frequency of the isolated mouse right atrium and the metabolic rate of the action potential of the rabbit sinus node specimen. Comparing the pharmacological...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/55A61K47/26A61K47/36A61K47/32A61K47/04A61K47/12A61K47/14A61P9/04A61P9/06A61P9/10
CPCA61K9/2018A61K9/2009A61K9/2013A61K9/2027A61K9/2059A61K9/28A61K31/55
Inventor 石井岗陈坤鹏刘妍
Owner CISEN PHARMA
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