Potassium aspartate medicine composition and preparation method

A technology of potassium aspartate and composition, which is applied in the directions of drug combination, drug delivery, and pharmaceutical formulation, can solve the problems of aggravating the disease condition and the large gap of sodium ions, and achieves the effect of low impurity content.

Inactive Publication Date: 2016-11-23
TIBET WEIXINKANG MEDICINE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In order to achieve a more suitable pH value tolerated by the human body, the potassium aspartate injection generally needs to be adjusted with a pH regulator. The instructions for Potassium Aspartate Injection with the word H201100321 indicate that sodium hydroxide and hydrochloric acid are used to adjust the pH value, but for some patients, bringing in more sodium ions may aggravate the condition, such as water and sodium retention and For patients with abnormal liver and kidney function, the introduction of sodium ions also brings more risks for quality control. For example, within the pH range normally tolerated by the human body, such as pH 4-8, the sodium ions required by different pH solutions vary greatly , at a lower pH value, such as pH4, it is necessary to use hydrochloric acid to adjust the pH value, as stated in the instruction manual of H201100321 Potassium Aspartate Injection

Method used

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  • Potassium aspartate medicine composition and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Take 17.12 kg of potassium aspartate (calculated as anhydrous matter), add it to 75 L of water for injection, heat and stir to dissolve, and after all the dissolution is complete, adjust the pH to 6.9 with 5% potassium hydroxide solution, add water for injection to 100L, filtered through a 0.22μm microporous membrane, filled in borosilicate glass ampoules with 10ml each, sealed by melting, and sterilized at 121°C for 12 minutes to obtain the product.

Embodiment 2

[0025] Take 17.12 kg of potassium aspartate (calculated as anhydrous matter), add it to 75 L of water for injection deoxygenated with high-purity nitrogen, heat and stir under the protection of nitrogen gas under the liquid and the liquid surface to dissolve, and wait until it is completely dissolved , adjust the pH to 6.9 with 5% potassium hydroxide solution prepared by passing high-purity nitrogen deoxygenation, add water for injection deoxygenated with high-purity nitrogen gas to 100L, filter with a 0.22μm microporous membrane, and use 10ml each Fill in medium borosilicate glass ampoules, fill with nitrogen and seal, and sterilize at 121°C for 12 minutes.

Embodiment 3

[0027] Except that the sterilization process was 121 degrees for 8 minutes, other preparations were the same as in Example 1 to obtain potassium aspartate injection.

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Abstract

The invention discloses a potassium aspartate injection medicine composition comprising potassium aspartate and injection water. The content of sodium ions in the composition is smaller than 20 / 1000000, and the content of fumaric acid in the composition is not higher than 0.2% of the content of potassium aspartate. The potassium aspartate injection medicine composition has a better clinic applicability, and the safety risk is lowered.

Description

technical field [0001] The invention relates to a pharmaceutical composition, in particular to an injection pharmaceutical composition containing potassium aspartate, and a preparation method. Background technique [0002] Potassium aspartate is the potassium salt of aspartic acid and is an electrolyte supplement. Aspartic acid is the precursor of oxaloacetate in the body, plays an important role in the tricarboxylic acid cycle, promotes energy metabolism, and is a catalyst for the synthesis and decomposition of high-energy phosphate compounds; participates in the production of nucleotides, and is an important substance for cell repair and regeneration ; Can promote the excretion of bile and bile pigment, have the effects of jaundice, reduce liver fat, increase liver glycogen, etc.; promote the development and differentiation of T lymphocytes into mature T lymphocytes, and have antiviral and antitumor effects. At the same time, aspartic acid also participates in the ornithi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/198A61K47/04A61P3/12
Inventor 胡军刘烽张勇
Owner TIBET WEIXINKANG MEDICINE CO LTD
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