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Stable ivabradine hydrochloride tablet and preparation method thereof

A technology of ivabradine hydrochloride and ivabradine, which is applied in the field of ivabradine hydrochloride tablets and its preparation, can solve the problems of related substances exceeding the standard, achieve the goals of improving stability, overcoming crystal transformation of raw materials, and ensuring quality Effect

Active Publication Date: 2019-06-14
YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In the traditional preparation process, ivabradine hydrochloride is very susceptible to crystal transformation due to the influence of the external environment, causing related substances to exceed the standard. Solving the stability of the raw material drug in the preparation process of ivabradine hydrochloride tablets has always been a research process. key issues in

Method used

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  • Stable ivabradine hydrochloride tablet and preparation method thereof
  • Stable ivabradine hydrochloride tablet and preparation method thereof
  • Stable ivabradine hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Prescription for ivabradine hydrochloride tablets

[0036]

[0037] The preparation method is as follows:

[0038] Raw material drug pretreatment: the raw material drug is crushed and passed through a 100-mesh sieve;

[0039] Weighing: Weigh each raw material and auxiliary material according to the weight ratio;

[0040] Mixing and granulation: add lactose monohydrate and corn starch into the wet granulator, pre-mix for 7 minutes, add an appropriate amount of purified water, mix and granulate for 3-5 minutes, make soft materials and sieve;

[0041] Drying and granulation: Dry the soft material at 60-65°C until the moisture content is below 3%.

[0042] Blending and tableting: Add dry granules, ivabradine hydrochloride, maltodextrin, colloidal silicon dioxide and magnesium stearate into a three-dimensional blender and blend for 10 minutes. After passing the test, select a φ8.5*4.6 special-shaped punch, and press the tablet according to the prescribed tablet weight....

Embodiment 2

[0045] Prescription for ivabradine hydrochloride tablets

[0046]

[0047] The preparation method is as follows:

[0048] Raw material drug pretreatment: the raw material drug is crushed and passed through a 100-mesh sieve;

[0049] Weighing: Weigh each raw material and auxiliary material according to the weight ratio;

[0050] Mixing and granulation: add lactose monohydrate and microcrystalline cellulose into the wet granulator, pre-mix for 7 minutes, add a certain amount of purified water, mix and granulate for 3-5 minutes, make soft materials and sieve;

[0051] Drying and granulation: Dry the soft material at 60-65°C until the moisture content is below 3%.

[0052] Blending and tableting: Add dry granules, ivabradine hydrochloride, sodium carboxymethyl starch, colloidal silicon dioxide and magnesium stearate into a three-dimensional blender and blend for 10 minutes. After passing the test, select a φ8.5*4.6 special-shaped punch, and press the tablet according to the ...

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Abstract

The invention discloses a stable ivabradine hydrochloride tablet. The stable ivabradine hydrochloride tablet comprises ivabradine hydrochloride, lactose monohydrate, a disintegrating agent, a bindingagent, a glidant and a lubricant, wherein the lactose monohydrate and the disintegrating agent are prepared into dry granules, then the dry granules are mixed with the ivabradine hydrochloride, the binding agent, the glidant and the lubricant, and the ivabradine hydrochloride tablet is obtained through compression. In addition, the invention also discloses a preparation method. The ivabradine hydrochloride tablet not only solves the problems of crystal transition of a raw material medicine and standard exceeding of related substances, but also has good product stability.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, in particular to a stable ivabradine hydrochloride tablet and a preparation method thereof. Background technique [0002] Ivabradine hydrochloride is ivabradine hydrochloride, the drug is suitable for sinus rhythm ≥ 75 beats / min, accompanied by systolic dysfunction in NYHA class Ⅱ ~ Ⅳ chronic heart failure patients, and standard treatment including β- Beta-blocker combination therapy, or for contraindication or intolerance of beta-blocker therapy. It is the first drug that can selectively inhibit the heterosexual cardiac pacing current (If) in clinical practice. Ivabradine hydrochloride is the first selective and specific If channel blocker developed by Servier. It is currently on the market in many European countries. [0003] The chemical name of ivabradine hydrochloride is: 7,8-dimethoxy-3-(3-[(1S)(4,5-dimethoxybenzocyclobutane-1-yl)methyl] -methylamino)propyl)-1,3,4,5,-tetrahydro-2H-benz...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/26A61K47/36A61K31/55A61P9/04
Inventor 宋林林陈东卫聪聪高露露
Owner YANGTZE RIVER PHARMA GRP BEIJING HAIYAN PHARMA
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