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Method for preparing dronedarone hydrochloride tablets

A dronedarone hydrochloride and prescription technology, which is applied in the field of preparation of dronedarone hydrochloride tablets, can solve the problems that the drug cannot meet the quality standard requirements, poor product consistency, unstable sample quality, etc.

Pending Publication Date: 2019-06-21
山东希尔康泰药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, when many manufacturers on the market are preparing and producing dronedarone hydrochloride tablets, usually due to insufficient preparation methods, the manufactured drugs cannot meet the quality standard requirements in terms of various properties, and the quality of the produced samples is unstable. The consistency of the product is poor

Method used

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  • Method for preparing dronedarone hydrochloride tablets
  • Method for preparing dronedarone hydrochloride tablets
  • Method for preparing dronedarone hydrochloride tablets

Examples

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Embodiment Construction

[0104] In order to clearly illustrate the technical features of this solution, the present invention will be described in detail below through specific implementation modes.

[0105] The preparation method of dronedarone hydrochloride tablets is characterized in that: the specific steps are as follows: S1: conduct a compatibility test of dronedarone hydrochloride raw materials and auxiliary materials;

[0106] According to the excipients involved in the standard product (that is, the original research product), hypromellose, starch, crospovidone, poloxamer 188, lactose, silicon dioxide, magnesium stearate, gastric dissolving Type film coating premix as the auxiliary material of this preparation;

[0107] And further through the compatibility test of the main drug and auxiliary materials, determine the type of auxiliary materials of this product;

[0108] Among them, dronedarone hydrochloride is mixed with lactose, starch, poloxamer 188, and crospovidone respectively according...

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Abstract

The invention relates to the field of medicine preparation, in particular to a method for preparing dronedarone hydrochloride tablets. The method for preparing the dronedarone hydrochloride tablets comprises the following specific steps: S1, carrying out compatibility test on raw materials and auxiliary materials of dronedarone hydrochloride; S2, preliminarily selecting preparation auxiliary materials; S3, processing raw materials and auxiliary materials; S4, mixing raw materials and auxiliary materials; S5, pelletizing; S6, drying granules; S7, granulating; S8, total mixing; S9, tabletting; S10, coating; S11, internal coating; and S12, external coating. The feasibility and reproducibility of the production process determined in the invention can be reflected well; the tablets can be effectively prepared, intermediate products in different stages can be accurately understood and controlled in time in a processing and preparation process, the quality of the intermediate products in thewhole production process is guaranteed, and thus, it can be ensured that the final product meets the processing requirement.

Description

technical field [0001] The invention relates to the field of medicine preparation, in particular to a method for preparing dronedarone hydrochloride tablets. Background technique [0002] Dronedarone is an antiarrhythmic drug for patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), reducing the risk of hospitalization, recent AF / AFL episodes and patients with cardiovascular risk factors, sinus Patients with normal rhythm or cardioverterable rhythm. [0003] At present, when many manufacturers on the market are preparing and producing dronedarone hydrochloride tablets, usually due to insufficient preparation methods, the manufactured drugs cannot meet the quality standard requirements in terms of various properties, and the quality of the produced samples is unstable. The consistency of the product is poor. Contents of the invention [0004] The technical solution adopted by the present invention to solve one of the above-mentioned tech...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/28A61K47/38A61K47/36A61K47/32A61K47/10A61K47/26A61K47/04A61K47/12A61K31/343A61P9/06
Inventor 张存国广国良王贺
Owner 山东希尔康泰药业有限公司
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