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Medicine composition of dronedarone hydrochloride solid dispersion and preparation method thereof

A technology of dronedarone hydrochloride and solid dispersion, applied in the field of dronedarone hydrochloride pharmaceutical composition and its new preparation field

Active Publication Date: 2012-11-07
开封大宋制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This invention adds β-cyclodextrin derivatives in the buffer system (pH range is 3-5), thereby improving the solubility of active ingredients, but this method of improving the solubility of dronedarone hydrochloride has a complicated manufacturing process , and may be less stable

Method used

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  • Medicine composition of dronedarone hydrochloride solid dispersion and preparation method thereof
  • Medicine composition of dronedarone hydrochloride solid dispersion and preparation method thereof
  • Medicine composition of dronedarone hydrochloride solid dispersion and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0073] Tablet prescription composition, each 1000 tablets are composed as follows:

[0074] Dronedarone Hydrochloride 426g

[0075] Microcrystalline Cellulose 300g

[0076] Croscarmellose Sodium 70g

[0077] Starch 1500 24g

[0078] Macrogol 4000 20g

[0079] 1% hydroxypropyl methylcellulose alcohol solution appropriate amount

[0080] Sodium saccharin amount

[0081] Magnesium Stearate 20g

[0082] Makes 1000 pieces

[0083] The preparation method is to prepare 1000 tablets, comprising the following steps:

[0084] 1) Dronedarone hydrochloride solid dispersion: Weigh dronedarone hydrochloride and microcrystalline cellulose respectively, add ethanol solution and stir to dissolve, evaporate under reduced pressure to remove absolute ethanol, vacuumize, dry overnight, and grind through No. 6 sieve ,spare.

[0085] 2) Pretreatment of excipients: Weigh all the medicinal solid excipients used, dry them in advance, pass through a No. 6 sieve, and then precisely weigh accordi...

Embodiment 2

[0090] Preparation method is the same as embodiment 1

[0091] Tablet prescription composition, each 1000 tablets are composed as follows:

[0092] Dronedarone Hydrochloride 213g

[0093] Microcrystalline Cellulose 150g

[0094] Croscarmellose Sodium 35g

[0095] Starch 1500 12g

[0096] Macrogol 4000 10g

[0097] 1% hydroxypropyl methylcellulose alcohol solution appropriate amount

[0098] Sodium saccharin amount

[0099] Magnesium Stearate 10g

[0100] Makes 1000 pieces

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Abstract

The invention discloses a medicine composition of dronedarone hydrochloride, which is a dispersible tablet. The medicine composition is a tablet which is prepared from dronedarone hydrochloride micronized by a solid dispersion technology and an auxiliary material. According to the medicine composition, the dissolubility of the primary medicine is improved, rapid disintegration of the medicine is facilitated, the absorbability of the medicine in the blood is increased, and the bioavailability of the primary medicine is improved. Moreover, the medicine composition has a favorable treatment effect on symptoms such as arrhythmia, atrial fibrillation and the like.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a dronedarone hydrochloride pharmaceutical composition and a new preparation method thereof. Background technique [0002] Atrial fibrillation is the most common clinical arrhythmia, the incidence rate in the elderly is as high as 10%, and it is on the rise with age. Radiofrequency ablation for the treatment of atrial fibrillation has its scope of application, and most of them accept radiofrequency ablation. Patients with frequent ablation still need long-term medication to control the onset of AF. However, so far, there is no drug for the treatment of atrial fibrillation with acceptable safety and efficacy. Amiodarone is one of the most effective antiarrhythmic drugs, especially in the treatment of atrial fibrillation, with few side effects on the heart and little risk of torsade de pointes; however, its severe extracardiac side effects limit the drug's us...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/343A61K47/38A61P9/06
Inventor 严洁黄欣
Owner 开封大宋制药有限公司
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