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Potassium magnessium aspartape sterilized powder injection and preparation thereof

A technology of potassium magnesium aspartate, sterile powder injection, applied in powder delivery, pharmaceutical formulations, inorganic active ingredients and other directions, can solve the problems of long freeze-drying cycle, large amount of excipients, and high production costs

Inactive Publication Date: 2008-11-12
SHENZHEN PKU WUZHOU PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, aspartic acid powder for injection in the domestic market is produced by many companies, all of which are made by freeze-drying process, which has disadvantages such as large amount of excipients, long freeze-drying cycle, and high production cost.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Take 3000ml of fresh water for injection, add the prescribed amount of aspartic acid, heat up to 60°C, add magnesium oxide and potassium hydroxide in turn, adjust the pH of the reaction solution to about 8.0, raise the reaction temperature to 80°C, and react under stirring For 2 hours, put in 0.2% (w / v) activated carbon, heat and boil for 10 minutes, filter, add an organic solvent (such as absolute ethanol, acetone, etc.) to the filtrate, stir while adding, let stand for 1h, filter, dry, The solid mixture of potassium aspartate and magnesium aspartate is obtained, which is subpackaged, capped and packaged under aseptic conditions to obtain potassium magnesium aspartate powder for injection.

Embodiment 2

[0024] Take 2000ml of fresh water for injection, add the prescribed amount of aspartic acid, heat up to 60°C, add magnesium oxide, adjust the pH of the reaction solution to about 8.0, raise the reaction temperature to 80°C, react under stirring for 2 hours, and put in 0.2 % (w / v) activated carbon was heated and boiled for 10 minutes, filtered, and the filtrate was spray-dried to obtain magnesium aspartate powder.

[0025] Take another 1500ml of fresh water for injection, add the prescribed amount of aspartic acid, heat up to 60°C, add potassium hydroxide, adjust the pH of the reaction solution to about 8.0, raise the reaction temperature to 80°C, react for 1 hour under stirring, and put in 0.2% (w / v) activated carbon was heated and boiled for 10 minutes, filtered, and the filtrate was spray-dried to obtain potassium aspartate powder.

[0026] The obtained magnesium aspartate and potassium aspartate powders are mixed, subpackaged, capped and packaged under aseptic conditions to...

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PUM

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Abstract

The invention discloses a potassium magnesium aspartate sterile powder injection and a method for preparing the same. The method is as follows: polyaspartate, magnesium oxide and potassium Hydroxide are prepared into a solution according to a certain method to obtain a liquid medicine, the liquid medicine is subject to reduced-pressure vacuum drying, solvent crystallization or spray drying, and is prepared into sterile packaged products for injection. The potassium magnesium aspartate sterile powder injection of the invention has the advantages of rapid redissolution, excellent stability, simple process, low production cost, suitability for industrial production, etc. the potassium magnesium aspartate sterile powder injection is mainly used for supplementing electrolyte, and can also be used for the treatment of hypokalemia and arrhythmia (mainly ventricular arrhythmia) caused by digitalism, and for the adjuvant treatment of myocarditis sequela, congestive heart failure, and miocardial infarction.

Description

technical field [0001] The invention relates to a sterile powder injection of potassium magnesium aspartate and a preparation method thereof. [0002] In this method, aspartic acid, magnesium oxide, potassium hydroxide, etc. are prepared according to a specific method, and the medicinal liquid obtained after the steps of heating, dissolving, decolorizing, and filtering is prepared by vacuum drying under reduced pressure, solvent crystallization, or spray drying. Sterile drug powder is packed in sterile containers under aseptic conditions, capped and packaged to make sterile powder for injection. The invention belongs to the technical field of chemical preparations. [0003] The invention is mainly used for electrolyte replenishment, and also can be used for adjuvant treatment of hypokalemia, arrhythmia (mainly ventricular arrhythmia) caused by digitalis poisoning, sequelae of myocarditis, congestive heart failure and myocardial infarction. Background technique [0004] Asp...

Claims

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Application Information

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IPC IPC(8): A61K33/08A61K33/00A61K31/198A61K9/19A61P3/12A61P9/00A61P9/04
Inventor 王金水刘伟
Owner SHENZHEN PKU WUZHOU PHARMA
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