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Sotalol hydrochloride for injection

A technology for sotalol hydrochloride and injection, which is applied in freeze-dried delivery, cardiovascular system diseases, amide active ingredients, etc. It can solve problems such as poor reconstitution effect, unsuitability for resuscitating critically ill patients, and long reconstitution time , to achieve good reconstitution effect, good reconstitution effect and stability, and short reconstitution time

Inactive Publication Date: 2015-02-18
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] Through experiments, we found that dissolving sotalol hydrochloride with an appropriate amount of excipients, such as mannose, dextran, polyethylene glycol, etc., and an appropriate amount of water for injection to make a solution, the reconstitution effect of the product is not good, especially the reconstitution time is long , so it is not suitable for rescuing critically ill patients in practical applications

Method used

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  • Sotalol hydrochloride for injection
  • Sotalol hydrochloride for injection
  • Sotalol hydrochloride for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Ratio of each raw material:

[0028]

[0029] The preparation process is as follows The preparation process is as follows:

[0030] (1) Measure 1200ml of water for injection, slowly add 80g of chitosan nanoparticles, and stir until dissolved;

[0031] (2) take by weighing sotalol hydrochloride 40g, then add the water for injection of 600ml, stir and make dissolving, by weight to volume, add the activated carbon for needles of 0.15% g / L of the total volume, stir and adsorb for 20 minutes, and ( 1) the middle chitosan nanoparticle solution is mixed;

[0032] (3) Add water for injection to 2000ml, and circulate and filter for 20-30 minutes, decolorize and filter until the feed liquid is clear, adjust the pH value to 5.0 with an appropriate amount of citric acid, and filter with a 0.22 μm filter membrane;

[0033] (4) Spray-dry the finely filtered medicinal liquid obtained in (3) at low temperature to obtain sterile powder, fill it, completely press the stopper, crimp ...

Embodiment 2

[0035] Ratio of each raw material:

[0036]

[0037] The preparation process is basically the same as in Example 1 except that auxiliary materials and dosage are different.

Embodiment 3

[0039] Ratio of each raw material:

[0040]

[0041]

[0042] The preparation process is basically the same as in Example 1 except that auxiliary materials and dosage are different.

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Abstract

The present invention belongs to the field of chemical drug preparations and particularly relates to sotalol hydrochloride powder injection for injection and a preparation method thereof. The sotalol hydrochloride powder injection comprises sotalol hydrochloride, chitosan nanoparticles and a PH (power of hydrogen) adjusting agent, wherein the chitosan nanoparticles adopted can significantly shorten the redissolving time of the sotalol hydrochloride, and improve the dissolution rate of the sotalol hydrochloride in injection. The sotalol hydrochloride provided by the invention has the advantages of good redissolving effect, more stable quality, high safety, high reliability, good convenience in transportation, and good application to industrial production, and the like.

Description

Technical field: [0001] The invention relates to a sotalol hydrochloride powder injection for injection, which belongs to the field of chemical drug preparations. Background technique: [0002] The chemical name of sotalol hydrochloride is: (RS)·4·(1·hydroxy·2·isopropylaminoethyl) methanesulfonanilide hydrochloride. It belongs to class II antiarrhythmic drugs (β-adrenergic receptor blockers), and also has the effect of class III antiarrhythmic drugs (drugs that prolong the action potential duration). Side effects are small, sotalol has the advantages of prolonging atrial and ventricular refractory periods, slowing down atrioventricular conduction, and blocking the forward and reverse conduction of atrioventricular bypass. Supraventricular tachycardia is effective, and its β-blocker effect can slow down the supraventricular tachycardia. It is clinically applicable to various life-threatening ventricular tachyarrhythmias. [0003] Currently, preparations using sotalol hydroc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K47/36A61K31/18A61P9/06
Inventor 赵志全刘万路冯中王钏舟徐志杰
Owner SHANDONG NEWTIME PHARMA
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