Oxiracetam injection

A technology for injection and water for injection, which is applied in the fields of drug delivery, cardiovascular system diseases, organic active ingredients, etc. It can solve the problem of lower solubility of oxiracetam, and achieve good storage stability and stable quality

Active Publication Date: 2009-04-01
广东世信药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] Due to its own molecular conformation of oxiracetam, there are two cases where the hydroxyl and carbonyl are located on the same side and the opposite side of the pyrrole ring. However, in the prior art, the oxiracetams with different spatial conformations cannot be separated , so when the hydroxyl group and carbonyl group of oxiracetam ar...

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0037] Example 1 Preparation of Oxiracetam Injection

[0038] Weigh 100g of oxiracetam, 150g of glucose, and 500ml of water for injection to dissolve in the dilute tank, control at 40-50°C, and stir until completely dissolved in 500ml of water for injection, cool the solution to 20°C, Add activated carbon to the solution prepared above for decolorization, then remove the activated carbon by filtration, add the prepared citric acid and sodium citrate buffer solution to adjust the pH value of the solution to 4.0, then add water for injection to 5000ml, Canned and sealed, at 105°C, the intermediate product in the canned and sealed bag was sterilized for 30 minutes to obtain oxiracetam injection, and the metal ion concentration of the oxiracetam injection was detected to be 0.5PPM.

Embodiment 2

[0039] Example 2 Preparation of Oxiracetam Injection

[0040] Weigh 100g of oxiracetam, 250g of glucose, and 800ml of water for injection to dissolve in the dilute tank, control at 50-60°C, and stir until completely dissolved in 800ml of water for injection, cool the solution to 20°C, and pour Add activated carbon to the solution prepared above for decolorization, then remove the activated carbon by filtration, add the prepared citric acid and sodium citrate buffer solution to adjust the pH value of the solution to 4.2, then add water for injection until 7000ml, Then use a 0.02um ultrafiltration membrane to perform ultrafiltration, and then centrifuge in a centrifuge at 2500r / min for 3min to remove insoluble matter, and add water for injection until the volume of the injection reaches 7000ml. The product was sterilized for 30 minutes, packed in cans and sealed into bags to obtain oxiracetam injection, and the metal ion concentration of the oxiracetam injection was detected to ...

Embodiment 3

[0041] Example 3 Preparation of Oxiracetam Injection

[0042] Weigh 100g of oxiracetam, 550g of glucose, and 1000ml of water for injection to dissolve in the dilute tank, control at 60-70°C, and stir until completely dissolved in 1000ml of water for injection, cool the solution to 20°C, and pour Add activated carbon to the solution prepared above for decolorization, then remove the activated carbon by filtration, add the prepared citric acid and sodium citrate buffer solution to adjust the pH value of the solution to 4.5, then add water for injection until 10000ml, Then use a 0.02um ultrafiltration membrane to perform ultrafiltration, and then centrifuge in a centrifuge at 2500r / min for 3min to remove insoluble matter, add water for injection until the volume of the injection reaches 10000ml, and at 105°C, place in the middle of the canned bag The product was sterilized for 30 minutes, packaged to obtain oxiracetam injection, and the metal ion concentration of the oxiracetam i...

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PUM

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Abstract

The invention relates to an oxiracetam injection solution which comprises 1 weight portion of oxiracetam, 1.5 to 5.5 weight portions of glucose and 50 to 100 weight portions of injection water, wherein, the pH value of the injection solution is 3.8 to 4.5. The invention also provides a preparation method of the oxiracetam injection solution which comprises the steps as follows: a) the bulk drug oxiracetam and the glucose or sodium chloride are solved in the injection water under the temperature of 40 DEG C to 70 DEG C to obtain dissolved solution; b) the dissolved solution is cooled to the room temperature, active carbon is added for decolorizing, the active carbon is removed by filtering, proper quantity of water is complemented, and citric acid and sodium citrate are added to adjust the pH value to 3.8 to 4.5 to obtain the dissolved solution with adjusted pH value; c) an intermediate product after encapsulation is sterilized; and d) the product after the sterilization is packed. The oxiracetam injection solution manufactured by the prescription and the preparation method of the invention has good storage stability.

Description

technical field [0001] The invention relates to pharmaceutical preparations, more specifically to oxiracetam injection, a medicine for treating brain damage. technical background [0002] Oxiracetam is a new generation of brain metabolism improving drug with the following structure: [0003] [0004] The chemical name is: 4-hydroxy-2-oxo-1-pyrrole acetamide, which is a new type of pyrrolidone (cyclic GABOB) derivative. It has a good curative effect on cerebrovascular disease, brain injury, brain tumor (postoperative), intracranial infection, dementia, and brain degenerative diseases. This product selectively acts on the cerebral cortex, stimulates specific neural pathways in the hippocampus, activates, protects and repairs brain nerve cells, but has no central sedative or exciting effect. Oxiracetam is safe and well tolerated by patients. [0005] Oxiracetam has a wide range of clinical indications. Mainly to promote the recovery of comatose patients after neurosurger...

Claims

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Application Information

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IPC IPC(8): A61K31/4015A61K9/08A61P9/10A61P25/00A61P25/28
Inventor 胡虹
Owner 广东世信药业有限公司
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