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A kind of ivabradine hydrochloride tablet and preparation method thereof

A technology for ivabradine hydrochloride and tablet, which is applied in the field of ivabradine hydrochloride formulation and its preparation, can solve the problems of inability to effectively solve the dissolution rate and stability, slow drug dissolution and the like

Active Publication Date: 2021-09-14
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This process is only applicable to the amorphous state of the drug. If it is changed to a crystalline form of the raw material drug during storage, the drug dissolution will be slowed down.
[0008] At present, the ivabradine tablet prepared in the prior art and its preparation method cannot effectively solve the problems of its dissolution rate and stability

Method used

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  • A kind of ivabradine hydrochloride tablet and preparation method thereof
  • A kind of ivabradine hydrochloride tablet and preparation method thereof
  • A kind of ivabradine hydrochloride tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] 1) Prescription

[0033]

[0034]

[0035] 2) Preparation method

[0036] Add the prescribed amount of ivabradine hydrochloride, citric acid, and copovidone into the ethanol solution, stir to dissolve, add this solution into the mixed powder of lactose, microcrystalline cellulose, and sodium carboxymethyl starch, and spray Granules, dried at 40°C, then added with prescribed amount of magnesium stearate, mixed evenly, compressed into tablets.

Embodiment 2

[0038] 1) Prescription

[0039]

[0040] 2) Preparation method

[0041] Add the prescribed amount of ivabradine hydrochloride, citric acid, and copovidone into the ethanol solution, stir to dissolve, add this solution to the mixed powder of mannitol and cross-linked sodium carboxymethylcellulose, and spray granulate , dried at 40°C, then added the prescribed amount of talcum powder, mixed evenly, and pressed into tablets.

Embodiment 3

[0043] 1) Prescription

[0044]

[0045]

[0046] 2) Preparation method

[0047] Add the prescribed amount of ivabradine hydrochloride, citric acid, and copovidone into the ethanol solution, stir to dissolve, add this solution into the mixed powder of sorbitol and crospovidone, spray granulate, 40°C After drying, add the prescribed amount of micropowder silica gel, mix well, and press into tablets.

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PUM

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an ivabradine hydrochloride tablet and a preparation method thereof. Specifically, ivabradine hydrochloride, copovidone, and citric acid are dissolved in an ethanol solution, and then pharmaceutically Granulated with acceptable excipients, dried and compressed into tablets. Compared with the prior art, the invention has good drug stability, rapid dissolution of the prepared preparation, simple process and is suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an ivabradine hydrochloride preparation and a preparation method thereof. Background technique [0002] Ivabradine hydrochloride is the hydrochloride salt of ivabradine, the first selective IF (control spontaneous diastolic depolarization in the sinus node and regulate heart rate) inhibitor, and has a selective effect on the sinus node It has no effect on intracardiac conduction, myocardial contraction, or ventricular repolarization. This product is different from the most commonly used drugs for treating angina pectoris, beta-receptor blockers, which will not cause adverse reactions such as airway constriction or spasm, bradycardia, or rebound phenomena. At present, it is generally believed that slowing down the heart rate is an important way to prevent and treat angina pectoris, and this product has opened up a promising new way for the treatmen...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/55A61K9/16A61K9/20A61K47/32A61P9/10
CPCA61K9/1635A61K9/2077A61K31/55A61P9/10
Inventor 张贵民郝贵周陈小伟
Owner LUNAN PHARMA GROUP CORPORATION