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Preparation method of acetyl glutamine injection

A technology of acetylglutamine and injection, applied in the direction of amide active ingredients, nervous system diseases, drug combination, etc., can solve the problems of poor product quality stability, clarity failure rate, strong irritation of liquid medicine, etc., and achieve clinical curative effect Effects of exacting, protecting and repairing nerve cells, improving clarity

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, the acetylglutamine injection in the domestic market is produced by many enterprises, all of which are prepared by traditional techniques. The products have poor quality stability, strong irritation of the liquid, high failure rate of clarity, and drop in pH value. Problems such as content decline and unstable curative effect cannot be solved

Method used

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  • Preparation method of acetyl glutamine injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A) Take 70% fresh water for injection at 80°C, add disodium hydrogen phosphate and sodium dihydrogen phosphate in the prescription, stir to dissolve, cool down to 15°C, adjust pH to 6.0, avoid light, add acetylglutamine in the prescription , sonicated for 15 minutes, refrigerated at 4°C for 24 hours, and ultrafiltered with an ultrafiltration membrane with a molecular weight cut-off of 10,000 to obtain an ultrafiltrate.

[0024] B) Take fresh water for injection with a preparation volume of 15% at 80°C, add disodium ethylenediaminetetraacetate in the prescription, stir to dissolve, add 0.1% activated carbon, heat and boil for 25 minutes, cool to 40°C, filter with 0.45μm Membrane decarbonization and filtration to obtain ultrafiltrate.

[0025] C) Mix the above two medicinal liquids under the condition of avoiding light, sonicate for 15 minutes, adjust the volume to 5.8, adjust the pH value to 5.8, pass the inspection of the intermediate product, filter the medicinal liqui...

Embodiment 2

[0027] A) Take 80% fresh water for injection at 90°C, add disodium hydrogen phosphate and sodium dihydrogen phosphate in the prescription, stir to dissolve, cool down to 25°C, adjust pH to 5.7, avoid light, add acetylglutamine in the prescription , sonicated for 30 minutes, refrigerated at 6° C. for 12 hours, and ultrafiltered with an ultrafiltration membrane with a molecular weight cut-off of 10,000 to obtain an ultrafiltrate.

[0028] B) Take fresh water for injection with a preparation volume of 15% at 80°C, add disodium ethylenediaminetetraacetate in the prescription, stir to dissolve, add 0.2% activated carbon, heat and boil for 15 minutes, cool to 50°C, filter with 0.45μm Membrane decarbonization and filtration to obtain ultrafiltrate.

[0029] C) Mix the above two medicinal liquids under the condition of avoiding light, sonicate for 10 minutes, adjust the volume to 6.2, adjust the pH value to 6.2, pass the inspection of the intermediate product, filter the medicinal liq...

Embodiment 3

[0031] A) Take 75% fresh water for injection at 85°C, add disodium hydrogen phosphate and sodium dihydrogen phosphate in the prescription, stir to dissolve, cool down to 20°C, adjust pH to 5.0, avoid light, add acetylglutamine in the prescription , sonicated for 25 minutes, refrigerated at 6° C. for 12 hours, and ultrafiltered with an ultrafiltration membrane with a molecular weight cut-off of 10,000 to obtain an ultrafiltrate.

[0032] B) Take 5% fresh water for injection at 85°C, add disodium ethylenediaminetetraacetate in the prescription, stir to dissolve, add 0.4% activated carbon, heat and boil for 30 minutes, cool to 60°C, filter with 0.45μm Membrane decarbonization and filtration to obtain ultrafiltrate.

[0033] C) Mix the above two medicinal liquids under the condition of avoiding light, sonicate for 25 minutes, adjust the volume to 5.7, adjust the pH value to 5.7, pass the inspection of the intermediate product, filter the medicinal liquid through a 0.22 μm filter m...

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Abstract

An acetylglutamide injection for improving brain function and treating coma, palsy, hypointelligence, dysmnesia, etc is prepared through mixing acetylglutamide and phosphate buffering liquid, ultrasonic treating, cold storage, ultrafiltration, mixing with Na2EDTA solution in dark condition, pouring in containers, sterilizing and lamp examining.

Description

technical field [0001] The present invention relates to a preparation method of acetylglutamine injection, a drug for improving brain function, in particular to a small-capacity injection mainly composed of acetylglutamine, which is prepared together with phosphate buffer and tested by ultrasound , cold storage, ultrafiltration and other technical treatment to obtain acetylglutamine ultrafiltrate, mixed with disodium ethylenediamine tetraacetate solution under light-proof conditions, filled, and finally sterilized, light inspected, and packaged to make small A volume injection belongs to the field of chemical preparations. The product can be infused intravenously. It has been proved by clinical trials that it can be infused intravenously. After passing through the blood-brain-spinal fluid barrier, acetylglutamine is decomposed into glutamic acid γ-aminobutyric acid (GABA), which participates in the information transmission of the central nervous system and participates in prot...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/16A61P25/00
Inventor 郭智华
Owner 巴里莫尔制药(通化)有限公司
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