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Antiarrhythmic medicinal composition and preparation method thereof

A composition and drug technology, applied in the direction of drug combination, medical formula, cardiovascular system diseases, etc., can solve the problems of body irritation, avoid drug hydrolysis, improve the area under the drug time curve, improve drug dissolution and The effect of the degree of absorption

Inactive Publication Date: 2012-07-18
JILIN BODA PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in terms of practical application, the dosage of sodium lauryl sulfate in this patent may cause acute toxicity such as irritation to the body

Method used

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  • Antiarrhythmic medicinal composition and preparation method thereof
  • Antiarrhythmic medicinal composition and preparation method thereof
  • Antiarrhythmic medicinal composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Table 1 Embodiment 1 prescription composition

[0028]

[0029]

[0030] Prepare a solid dispersion:

[0031] Will (Polyethylene glycol 6000-vinyl caprolactam-vinyl acetate copolymer) and dronedarone hydrochloride (calculated by base) are mixed according to the prescription ratio to obtain a physical mixture. Set the temperature and rotational speed of the hot-melt extruder, add the physical mixture into the feeder, extrude, crush, sieve, and set aside.

[0032] Post-processing of solid dispersions:

[0033] Mix the solid dispersion of dronedarone hydrochloride, microcrystalline cellulose, hypromellose, and crospovidone according to the prescription ratio in the above table, then add the prescribed amount of magnesium stearate and silicon dioxide, and mix well.

[0034] The above mixture can be directly compressed into tablets, and can also be filled into capsules or directly packaged into granules. The same applies to other embodiments.

Embodiment 2

[0036] Table 2 embodiment 2 prescription composition

[0037]

[0038] The preparation process is the same as in Example 1.

Embodiment 3

[0040] Table 3 Embodiment 3 prescription composition

[0041]

[0042] The preparation process is the same as in Example 1.

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Abstract

The invention relates to an antiarrhythmic medicinal composition and a preparation method thereof. According to the composition, active ingredients comprise dronedarone or pharmaceutically-acceptable salt thereof, and non-active ingredients comprise one or more of polymers and multiple common additives of preparations. The preparation process for the composition comprises the key step of preparing solid dispersoid by a hot-melting extrusion method, so that tablets, capsules and granules can be prepared. The invention has the advantages that: a preparation with a high dissolution rate can be prepared according to a proper formula by a simple and pollution-free process, and the preparation can be absorbed well in bodies; and samples are stable under the condition of accelerated tests.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to an antiarrhythmic drug composition and a preparation method thereof. Background technique [0002] In the field of treating arrhythmia, amiodarone is one of the most effective drugs, but long-term use of amiodarone has many adverse reactions, among which thyroid, retinal damage and pulmonary toxicity are the main ones. The above adverse reactions and the iodine in its structure close relationship. Dronedarone is a benzofuran derivative. It has a chemical structure similar to amiodarone without iodine. It has minimal effect on thyroid hormones. Its lipophilicity is weaker than that of amiodarone, and phospholipids will not be deposited in the lungs after taking it. , so adverse reactions outside the cardiovascular system are less than amiodarone. In addition, dronedarone has blocking effects on calcium, potassium, and sodium channels, and has anti-adrenergi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/343A61K9/14A61K47/38A61K47/32A61K47/34A61P9/06
Inventor 孙蕴哲张翠霞许向阳
Owner JILIN BODA PHARMA
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