Potassium magnesium aspartate freeze-dried powder preparation for injection and preparation method of preparation

A technology of potassium magnesium aspartate freeze-dried powder and magnesium aspartate, which is applied in the field of medicine, can solve the problem that the stability and resolubility of the preparation need to be improved, the amount of excipients affects the freeze-drying of the product, and the medicinal effect of the powder injection is general, etc. problems, to achieve the effect of improving resolubility, scientific and reasonable preparation methods, and avoiding curative effect problems

Active Publication Date: 2013-05-22
SHANXI PUDE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The above-mentioned technical solutions all directly use potassium aspartate and magnesium aspartate as raw materials to prepare freeze-dried preparations, and simultaneously use mannitol as a freeze-dried excipient. Solubility needs to be improved
In addition, due to the excessive amount of excipients in the prescription, the medicinal effect of the powder injection is mediocre, and the stability is not very good after a long storage time. There have been cases of significant side effects in actual clinical practice.
At the same time, the excessive amount of auxiliary materials also affects the freeze-drying of the product, thereby limiting its application.

Method used

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  • Potassium magnesium aspartate freeze-dried powder preparation for injection and preparation method of preparation
  • Potassium magnesium aspartate freeze-dried powder preparation for injection and preparation method of preparation
  • Potassium magnesium aspartate freeze-dried powder preparation for injection and preparation method of preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Prescription: 1000 bottles are prepared from the following raw materials: potassium aspartate 500g, magnesium aspartate 500g and lactose 400g, add water for injection to 12L;

[0047] Preparation:

[0048] (1) Add 60% of the prescription water for injection at 70°C to the concentrated preparation tank, slowly add the prescription amount of potassium aspartate, magnesium aspartate and lactose into the tank in turn, stir to dissolve, and add water for injection to the full amount;

[0049] (2) After the dissolution is complete, take a sample to measure the pH value, and adjust the pH value to 6.0 with a pH regulator;

[0050] (3) Add the wetted activated carbon with a weight-to-volume ratio of 0.1% into the liquid preparation tank, control the liquid temperature at 58 °C and stir for 30 minutes, and decarbonize and filter through a 0.45 μm microporous membrane;

[0051] (4) Filter the solution from the concentrated preparation tank to the dilute preparation tank; test t...

Embodiment 2

[0056] Prescription: 1000 bottles are prepared from the following raw materials: potassium aspartate 1000g, magnesium aspartate 1000g and lactose 800g, add water for injection to 25L;

[0057] Preparation:

[0058] (1) Add 60% of the prescription water for injection at 70°C to the concentrated preparation tank, slowly add the prescription amount of potassium aspartate, magnesium aspartate and lactose into the tank in turn, stir to dissolve, and add water for injection to the full amount;

[0059] (2) After the dissolution is complete, take a sample to measure the pH value, and adjust the pH value to 6.0 with a pH regulator;

[0060] (3) Add the wetted activated carbon with a weight-to-volume ratio of 0.1% into the liquid preparation tank, control the liquid temperature at 58 °C and stir for 30 minutes, and decarbonize and filter through a 0.45 μm microporous membrane;

[0061] (4) Filter the solution from the concentrated preparation tank to the dilute preparation tank; test...

Embodiment 3

[0066] Prescription: 1000 bottles are prepared from the following raw materials: potassium aspartate 450g, magnesium aspartate 450g and lactose 360g, add water for injection to 9L;

[0067] Preparation:

[0068] (1) Add 50% water for injection at 60°C in the concentrated dispensing tank, slowly add potassium aspartate, magnesium aspartate and lactose in the prescribed amount into the tank, stir and dissolve, and add water for injection to the full amount;

[0069] (2) After the dissolution is complete, take a sample to measure the pH value, and adjust the pH value to 5.0 with a pH regulator;

[0070] (3) Add the wetted activated carbon with a weight-to-volume ratio of 0.1% into the dosing tank, control the liquid temperature at 55°C and stir for 20 minutes, and decarbonize and filter through a 0.45μm microporous membrane;

[0071] (4) Filter the solution from the concentrated preparation tank to the dilute preparation tank; test the intermediate; after passing the test, the ...

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Abstract

The invention relates to potassium magnesium aspartate freeze-dried powder preparation for injection. The potassium magnesium aspartate freeze-dried powder preparation for injection is prepared from the following materials in parts by weight: 400-600 parts of potassium aspartate, 400-600 parts of magnesium aspartate and 320-480 parts of lactose. The freeze-dried powder preparation disclosed by the invention has the advantages of being simple in prescription and scientific and reasonable in preparation method, so that the freeze-dried product is more fluffy and porous, thereby remarkably improving the re-dissolution of the freeze-dried powder preparation during the clinical use process; meanwhile, the stability of the preparation is further improved on the condition of low auxiliary material dosage and less categories, so that the medication safety of the patient is ensured.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a potassium magnesium aspartate freeze-dried powder injection preparation for injection and a preparation method thereof. Background technique [0002] Potassium-magnesium aspartate is a sugar salt and acid-base balance regulator. It is used for the treatment of hypokalemia, hypokalemia and arrhythmia caused by digitalis poisoning, viral hepatitis, liver cirrhosis and hepatic encephalopathy. Currently, aspartic acid in clinical application is mostly water injection, which is easy to cause secondary pollution during clinical use, and has the problems of easy damage and inconvenient transportation and storage. In addition, the prior art also discloses some technical solutions for preparing the preparation into freeze-dried powder for injection, such as: [0003] Chinese application 200510051465.0 discloses a preparation method of potassium magnesium aspartate freeze-dried powder injection ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/198A61K9/19A61P3/12A61P39/02A61P9/06A61P31/12A61P1/16A61P25/00
Inventor 李立忠王勇解晓荣李润宝苏志强姚荷云闫洁胡成伟
Owner SHANXI PUDE PHARMA CO LTD
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