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Preparation method of potassium magnesium aspartate freeze dried powder injection

A technology of potassium magnesium aspartate freeze-dried powder and aspartic acid, applied in the field of freeze-dried powder injection, can solve the problems of unqualified rate of clarity, incomplete removal of impurities, influence on clinical application, etc., and achieve improved clarity , good solubility, reduced irritation effect

Inactive Publication Date: 2006-09-13
巴里莫尔制药(通化)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, aspartic acid freeze-dried powder for injection in the domestic market is produced by many companies, all of which are prepared by traditional techniques. The existing products have poor stability, strong irritation, poor solubility, and high failure rate of clarity. , Unstable curative effect and other problems can not be solved, the main reason is that some impurities are not completely removed in the preparation process, which affects the clinical application

Method used

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  • Preparation method of potassium magnesium aspartate freeze dried powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] 1) Take 75% fresh water for injection at 85°C of the prepared amount, add aspartic acid in the prescription and stir to dissolve, then add magnesium oxide in the prescription, ultrasonicate for 60 minutes, refrigerate at 4°C for 12 hours, use Ultrafiltration membrane ultrafiltration to obtain filtrate I.

[0026] 2) Take 30% fresh water for injection at 90°C of the prepared amount, add potassium hydroxide and mannitol in the prescription to dissolve, add 0.1% activated carbon, heat and boil for 15 minutes, cool down to 40°C in circulation, filter with 0.45 μm microporous Membrane decarbonization and filtration to obtain filtrate II.

[0027] 3) Add the above medicinal solution II to medicinal solution I, mix evenly, constant volume, adjust pH to 5.8, after passing the inspection of the intermediate product, filter the medicinal solution through a terminal 0.22 μm filter membrane to sterilize and filter, and then fill it in penicillin in dark place bottle, refrigerated ...

Embodiment 2

[0029] 1) Take 80% fresh water for injection at 90°C of the prepared amount, add aspartic acid in the prescription and stir to dissolve, then add magnesium oxide in the prescription, treat with ultrasound for 30 minutes, refrigerate at 6°C for 24 hours, and use water with a molecular weight cut-off of 10,000 Ultrafiltration membrane ultrafiltration to obtain filtrate I.

[0030] 2) Take 25% fresh water for injection at 85°C of the prepared amount, add potassium hydroxide and mannitol in the prescription to dissolve, add 0.05% activated carbon, heat and boil for 30 minutes, cool down to 30°C in circulation, filter through 0.45μm microporous Membrane decarbonization and filtration to obtain filtrate II.

[0031] 3) Add the above medicinal solution II to medicinal solution I, mix evenly, constant volume, and adjust pH to 6.3. After passing the inspection of the intermediate product, the medicinal solution is sterilized and filtered through a terminal 0.22 μm filter membrane, and ...

Embodiment 3

[0033] 1) Take 70% fresh water for injection at 80°C of the prepared amount, add aspartic acid in the prescription and stir to dissolve, then add magnesium oxide in the prescription, ultrasonicate for 40 minutes, refrigerate at 0°C for 24 hours, and use water with a molecular weight cut-off of 8000 Ultrafiltration membrane ultrafiltration to obtain filtrate I.

[0034] 2) Take 10% fresh water for injection at 80°C of the prepared amount, add potassium hydroxide and mannitol in the prescription to dissolve, add 0.3% activated carbon, heat and boil for 20 minutes, cool down to 35°C in circulation, filter with 0.45 μm microporous Membrane decarbonization and filtration to obtain filtrate II.

[0035] 3) Add the above medicinal solution II to medicinal solution I, mix evenly, constant volume, and adjust pH to 6.0. After passing the inspection of the intermediate product, filter the medicinal solution through a terminal 0.22 μm filter membrane to sterilize and filter it, and then f...

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Abstract

A freeze-dried powder injection of spartase for supplementing electrolyte and treating arrhythmia, myocarditis sequelae, congestive heart failure, myocardial infarction, etc is prepared through reaction between L-aminobutanedioic acid and magnesium oxide, ultrasonic treating, cold storage, ultrafiltration, adding the filtered liquid prepared from potassium hydroxide and mannitol, filling in containers in dark condition, freeze drying and sealing.

Description

technical field [0001] The invention relates to a preparation method of a freeze-dried powder injection of potassium magnesium aspartate for injection of an electrolyte replenishing drug, in particular to a freeze-dried powder injection mainly composed of aspartic acid. In this method, aspartic acid and magnesium oxide are prepared according to a specific method, and processed by ultrasonic, refrigeration, and ultrafiltration technology, and then prepared together with the filtrate prepared by potassium hydroxide and mannitol, filled in a dark place, freeze-dried, and capped After packaging, it is made into a finished freeze-dried powder injection of potassium magnesium aspartate for injection, which belongs to the field of chemical preparations. This product can be administered intravenously. Aspartic acid is the precursor of oxaloacetate in the body and plays an important role in the tricarboxylic acid cycle. At the same time, aspartic acid also participates in the ornithin...

Claims

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Application Information

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IPC IPC(8): A61K31/198A61K9/19A61P3/12
Inventor 郭智华
Owner 巴里莫尔制药(通化)有限公司
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