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Ozagrel sodium injection and preparation method thereof

A technology for sodium ozagrel and injection, which is applied in pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. Long-term storage, etc.

Active Publication Date: 2011-06-22
HAINAN LEVTEC PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the patent application did not provide the stability test data of ozagrel sodium injection, and did not indicate whether it can be stored for a long time

Method used

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  • Ozagrel sodium injection and preparation method thereof
  • Ozagrel sodium injection and preparation method thereof
  • Ozagrel sodium injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Example 1 1000 ozagrel sodium injections

[0049] Ozagrel 36.48g

[0050] Sodium hydroxide 6.4g

[0051] Citric acid 2.4g

[0052] Water for injection 2000ml

[0053] Made 1000 pieces

[0054] In the clean area, first add the prescribed amount of sodium hydroxide to an appropriate amount of water for injection, stir to dissolve, then add the prescribed amount of ozagrel, stir and dissolve as solution I; weigh the prescribed amount of citric acid, add a small amount of injection Dissolve in water, add to solution I, mix well, adjust the pH value to about 8.0, and use it as solution II; take activated carbon with a prescription liquid volume of 0.1% (W / V), add appropriate amount of water for injection and stir well, add to solution II, and add water for injection To the full amount, stir and circulate for 20 minutes, first coarse filtration and decarbonization, and then fine filtration through a 0.22μm filter membrane, take the fine filtrate to test the content, pH va...

Embodiment 2

[0055] Example 2 1000 ozagrel sodium injections

[0056] Sodium Ozagrel 72.96g

[0057] Appropriate amount of sodium hydroxide

[0058] Citric acid 4.8g

[0059] Water for injection 4000ml

[0060] Made 1000 pieces

[0061] In the clean area, first add the prescribed amount of ozagrel sodium to an appropriate amount of water for injection, stir and dissolve as solution I, weigh the prescribed amount of citric acid, add a small amount of water for injection to dissolve, add to solution I, and mix evenly. Add sodium hydroxide to adjust the pH value of the solution to about 9.5, as solution II; take activated carbon with a prescription liquid volume of 0.3% (W / V), add appropriate amount of water for injection and stir well, add to solution II, add water for injection to the full amount, and stir cycle For 30 minutes, decarbonize by coarse filtration first, then fine filter through a 0.22μm filter membrane, take the fine filtrate to test the content, pH value, endotoxin, visib...

Embodiment 3

[0062] Example 3 1000 ozagrel sodium freeze-dried powder injections

[0063] Ozagrel 18.24g

[0064] Sodium hydroxide 3.2g

[0065] Citric acid 1.2g

[0066] Water for injection 1000ml

[0067] Made 1000 pieces

[0068] In the clean area, first add the prescribed amount of sodium hydroxide to an appropriate amount of water for injection, stir to dissolve, then add the prescribed amount of ozagrel, stir and dissolve as solution I; weigh the prescribed amount of citric acid, add a small amount of injection Dissolve in water, add to solution I, mix evenly, adjust pH to about 8.5, and use it as solution II; take active carbon of 0.3% (W / V) of the total liquid, add appropriate amount of water for injection and stir well, add to solution II, add water for injection to The whole amount is stirred and circulated for 40 minutes. First, it is decarbonized by coarse filtration, and then finely filtered by a 0.22 μm filter membrane. The fine filtrate is tested for content, pH value, e...

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PUM

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Abstract

The invention relates to an ozagrel sodium injection and a preparation method thereof, in particular to an ozagrel sodium injection for treating acute thrombotic cerebral infarction and movement disorders concomitant with cerebral infarction, preferably injection solution and lyophilized powder injection. The ozagrel sodium injection mainly comprises ozagrel serving as an active component and sodium hydroxide and citric acid serving as auxiliary materials. Solvent in the injection solution is water for injection. Excipient in the lyophilized powder injection is mannitol and / or sorbitol which can be combined in any one or two optional medicinal proportions, or no excipient is added.

Description

technical field [0001] The invention relates to an ozagrel sodium injection and a preparation method thereof, in particular to an injection used for treating acute thrombotic cerebral infarction and the motor disorder accompanied by cerebral infarction, and belongs to the technical field of pharmaceutical preparations. Background technique [0002] Ozagrel sodium, English name: Sodium Ozagrel, chemical name: trans-3-[4-(1H-imidazolyl-1-methyl)phenyl]-2-sodium acrylate, its chemical formula: [0003] [0004] Sodium ozagrel is the first thromboxane synthetase inhibitor listed in China, mainly used for the treatment of acute thrombotic cerebral infarction and the accompanying motility disorder of cerebral infarction, and for the improvement of cerebral vasospasm after subarachnoid hemorrhage surgery Contraction and concurrent cerebral ischemic symptoms. It can not only dissolve the thrombosis protein, but also prevent the formation of thrombus. [0005] Although ozagrel s...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K9/19A61K31/4174A61K47/12A61P9/10A61P7/02
Inventor 张志宏朱玉龙娇王欣
Owner HAINAN LEVTEC PHARMA
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