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Amiodarone hydrochloride injection and preparation method thereof

A technology of amiodarone hydrochloride and injection, which is applied in the fields of pharmaceutical formulations, cardiovascular system diseases, drug combinations, etc., can solve problems such as unwanted side effects, achieve the effect of avoiding toxic side effects and enhancing solubility

Inactive Publication Date: 2015-09-09
ZHEJIANG POLY PHARMA +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, polysorbate 80 and benzyl alcohol are known to cause unwanted side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] Embodiment 1: prepare amiodarone hydrochloride injection

[0015] Preparation method: put 0.5ml of water for injection into the container and keep it at a temperature range of 60±3°C, add 0.378mg of citric acid and 0.18mg of sodium citrate dihydrate in sequence to control the pH at 3.5, then add 9mg of Glu- Stir and dissolve G3.0 (glutamic acid modified polyamide-amine dendrimers), then add 1.5mg of amiodarone hydrochloride, continue to stir for a while, add 42.1mg of anhydrous glucose and mix, add water to 1ml, continue Mix for more than 5 minutes, add an appropriate amount of hydrochloric acid and measure the pH value to 3.5, and filter the solution aseptically.

[0016] The present invention utilizes that the polyamide-amine dendrimers have nanoscale size (diameters below 10 generations are all less than 20nm), symmetrical and divergent three-dimensional structures, low dispersion, high permeability, and a large number of functional groups and molecules on the molecu...

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PUM

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Abstract

The invention relates to an amiodarone hydrochloride injection and a preparation method thereof. Per ml of the amiodarone hydrochloride injection contains 1mg-2mg of amiodarone hydrochloride, and 5-15mg of polyamide-amine dendrimers. A pH adjustment value adjusts the pH value to 3.5-4, and an osmotic pressure adjustment agent adjusts the osmotic pressure to isotonic.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to amiodarone hydrochloride injection and a preparation method thereof. Background technique [0002] Since the 1990s, amiodarone has been proven to be a widely used antiarrhythmic drug by multiple clinical trials, accounting for 1 / 3 of the antiarrhythmic drug prescription market in the United States and Europe. Amiodarone is a multi-channel blocker. It has been found in electrophysiological research and clinical application that the drug can achieve the electrophysiological effects of class I, II, III, and IV antiarrhythmic drugs. It has anti-myocardial ischemia and vasodilator effects, and has anti-sympathetic effects, and can regulate the activation of neuroendocrine hormones in heart failure. The results of large-scale clinical trials show that amiodarone is suitable for various supraventricular and ventricular tachyarrhythmias, including atrial flutter and fibrillati...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/343A61K47/34A61P9/06
Inventor 范敏华孙军
Owner ZHEJIANG POLY PHARMA
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