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Method for preparing potassium aspartate injection

A technology of potassium aspartate and aspartic acid, which is applied in the direction of medical preparations containing active ingredients, pharmaceutical formulas, anti-toxins, etc., can solve the problems of cumbersome industrial production conditions and poor product stability, and prevent air pollution , Guarantee the effect of quality

Inactive Publication Date: 2014-03-26
沈阳药联科技创新有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are tablets, capsules, oral liquids, and injections about the pharmaceutical preparations of potassium aspartate, and there are many reports on the process research of various preparations, but there are problems such as poor product stability and cumbersome industrial production conditions. various problems

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 5

[0094] Prepare 10% (w / w) sodium hydroxide and 10% (w / w) hydrochloric acid solution for later use.

[0095] (a) Add water for injection with 70% of the total liquid volume into the concentrated preparation tank first, and start stirring.

[0096] (b) Add the weighed potassium aspartate into the concentrated preparation tank, stir for 20-30 minutes, wait until it is completely dissolved, start the small circulation of the concentrated preparation tank, take 50ml of the liquid medicine from the sampling valve for detection, and use hydrochloric acid solution Or adjust the pH value to 5.5~7.5 with sodium hydroxide solution.

[0097] (c) Add the prescribed amount of medicinal charcoal, stir for 30 minutes at 75~85°C, and then filter the medicinal solution through a decarbonization filter and a precision filter into a thinning tank while it is still hot.

[0098] (d) Add about 50L of water for injection into the concentrated preparation tank, and then send it to the thin preparatio...

Embodiment 6

[0104] Prepare 10% (w / w) sodium hydroxide and 10% (w / w) hydrochloric acid solution for later use.

[0105] (a) Add water for injection of 60% of the total liquid volume into the concentrated preparation tank first, start stirring,

[0106] (b) Add the weighed potassium aspartate into the concentrated preparation tank, stir for 20-30 minutes, wait until it is completely dissolved, start the small circulation of the concentrated preparation tank, take 50ml of the liquid medicine from the sampling valve for detection, and use hydrochloric acid solution Or adjust the pH value to 4.5~6.5 with sodium hydroxide solution.

[0107] (c) Add the prescribed amount of medicinal charcoal, stir at 70-80°C for 30 minutes, and then filter the medicinal solution through a decarbonization filter and a precision filter into a dilute tank while it is still hot.

[0108] (d) Add about 50L of water for injection into the concentrated preparation tank, and then send it to the thin preparation tank t...

Embodiment 7

[0114] Prepare 10% (w / w) sodium hydroxide and 10% (w / w) hydrochloric acid solution for later use.

[0115] (a) Add water for injection with a total volume of 65% of the total dosing volume into the concentrated preparation tank, start stirring,

[0116] (b) Add the weighed potassium aspartate into the concentrated preparation tank, stir for 20-30 minutes, wait until it is completely dissolved, start the small circulation of the concentrated preparation tank, take 50ml of the liquid medicine from the sampling valve for detection, and use hydrochloric acid solution Or adjust the pH value to 6.5~9.5 with sodium hydroxide solution.

[0117] (c) Add the prescribed amount of medicinal charcoal, stir at 80-90°C for 30 minutes, and then filter the medicinal solution through a decarbonization filter and a precision filter into a dilute tank while it is still hot.

[0118] (d) Add about 50L of water for injection into the concentrated preparation tank, and then send it to the thin prep...

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Abstract

The invention provides a method for preparing a potassium aspartate injection. The method comprises the following steps: (a) adding injection water accounting for 60-70 percent of the total volume of the preparation liquid into a concentrating preparation tank; (2) adding potassium aspartate into the concentrating preparation tank, stirring for 20-30 minutes until the potassium aspartate is completely dissolved, detecting and regulating the pH value to 4.5-9.5; (c) adding medicinal charcoal, stirring for 20-40 minutes at 70-90 DEG C, filtering the liquid medicine into a diluting preparation tank through a decarburization filter and a precise filter when the liquid medicine is hot; (d) adding injection water into the concentrating preparation tank, feeding the mixture to the diluting preparation tank through a filter to enable the liquid medicine in the diluting preparation tank to achieve the specific total volume of the preparation liquid; (e) stirring the liquid medicine in the diluting preparation tank for 5-10 minutes to lead the liquid medicine to be uniform, introducing the liquid medicine through a sterilization filter, and sampling to make intermediate inspection; (f) encapsulating and sterilizing.

Description

technical field [0001] The invention relates to the field of medicinal chemistry, and provides a preparation method of a pharmaceutical preparation, in particular a preparation method of potassium aspartate injection. Background technique [0002] Aspartic acid is the precursor of oxaloacetate in the human body and plays an important role in the tricarboxylic acid cycle. At the same time, it also participates in the ornithine cycle, promotes the metabolism of ammonia and carbon dioxide, and makes it generate urea, thereby reducing the content of ammonia and carbon dioxide in the blood. Aspartic acid has a strong affinity with cells and can be used as a carrier of potassium ions, allowing potassium ions to return to cells and maintain their normal functions. Therefore, drugs containing potassium aspartate are often used clinically for the treatment of acute jaundice hepatitis, hepatic insufficiency, other acute and chronic liver diseases, and hypokalemia, arrhythmia and myoc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/198A61P1/16A61P3/12A61P9/00A61P39/02
Inventor 于航
Owner 沈阳药联科技创新有限公司
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