'Huilaxitan' injection, and its prepn. method

The technology of a racetam injection and aniracetam, which is applied in the field of brain function improving drugs, can solve problems such as poor water solubility, and achieve the effects of improving compliance, reducing side effects and ensuring therapeutic effects.

Inactive Publication Date: 2006-01-25
CHANGYUAN BIOLOGICAL PHARMA TECH WUXI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] The object of the present invention is to provide aniracetam injection and preparation method thereof, utilize non-aqueous solvent to overcome the problem of the poor solubility of aniracetam raw material liquid medicine, prepare the aniracetam injection (comprising aniracetam injection) that meets injection specifications and standard requirements Tan small-volume injection and aniracetam large-volume injection), provide new injection dosage forms for the improvement of brain function in clinical medicine, memory loss in middle-aged and elderly people, and memory loss after cerebrovascular disease to meet the needs of clinical medicine

Method used

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  • 'Huilaxitan' injection, and its prepn. method

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Prescription: 4g of aniracetam, 100ml of propylene glycol, 40ml of ethanol, and a preparation volume of 200ml. Aniracetam API, propylene glycol, ethanol, etc. All raw materials, solvents, and additives should meet the standards for injection.

[0028]Dissolve 4g of aniracetam raw material in 100ml of propylene glycol, heat to 70-90 degrees Celsius to promote dissolution, add 100ml of 40% ethanol prepared in advance with water for injection during or after dissolution, mix well, and let stand One hour later, the preparation of the injection was completed. Add 0.001% to 0.05% activated carbon for needles according to the weight and volume ratio of the prepared liquid, mix for half an hour, coarse filter, fine filter, fill into 10ml per tube (10ml: 200mg) or fill into each tube 5ml specification (5ml: 100mg) or filled into each 1ml specification (1ml: 20mg), sealed, sterilized, leak tested, light inspected, printed, packaged, checked and put into storage, and finally anir...

Embodiment 2

[0030] Prescription: 4g of aniracetam, 100ml of propylene glycol, 40ml of ethanol, 0.2g of sodium bisulfite, 10% sodium hydroxide solution to adjust the pH to meet the requirements of the injection, and the preparation volume is 200ml. Aniracetam API, propylene glycol, ethanol, etc. All raw materials, solvents, and additives should meet the standards for injection.

[0031] Dissolve 4g of aniracetam crude drug in 100ml of propylene glycol, heat to 70-90 degrees Celsius to promote dissolution, add 100ml of 40% ethanol prepared in advance with water for injection during or after dissolution, and mix well. Add 0.2 g of sodium bisulfite, adjust the pH to meet the standard with 10% sodium hydroxide solution, mix evenly, and complete the preparation of the injection after standing for one hour. Add the prepared liquid to 0.001% to 0.05% of the weight-to-volume ratio, add activated carbon for needles and mix for half an hour, then coarsely filter, finely filter, and fill into 10ml pe...

Embodiment 3

[0033] Prescription: 4g of aniracetam, 100ml of propylene glycol, 40ml of ethanol, and a preparation volume of 200ml. Aniracetam API, propylene glycol, ethanol, etc. All raw materials, solvents, and additives should meet the standards for injection.

[0034] Dissolve 4g of aniracetam raw material in 100ml of propylene glycol, heat to 70-90 degrees Celsius to promote dissolution, add 40ml of ethanol during or after dissolution, and mix well. Add water for injection to make the volume to 200ml, mix evenly, and complete the preparation of the injection after standing for one hour. Add the prepared liquid to 0.001% to 0.05% of the weight-to-volume ratio, add activated carbon for needles and mix for half an hour, then coarsely filter, finely filter, and fill into 10ml per bottle (10ml: 200mg) or 5ml per bottle specifications (5ml: 100mg) or filled into 1ml specifications (1ml: 20mg) per vial, sealed, sterilized, leak tested, light inspected, printed, packaged, checked and put into...

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Abstract

An injection of aniracetam for intravenous injection is prepared from aniracetam, dissolved by propylene glycol solvent, the mixture of alcohol and water for injection, anti-oxidizing agent and pH regulator.

Description

technical field [0001] The invention relates to aniracetam injection, a medicine for improving brain function, and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Aniracetam (Aniracetam), its chemical name is 1-(4-methoxybenzoyl)-2-pyrrolidone, and its molecular formula is C 12 h 13 NO 3 , the molecular weight is 219.24, and the molecular structure formula is [0003] [0004] Aniracetam was successfully developed by Swiss Roche Company in 1978, and has applied for patents in Western Europe, Spain, South Africa and other countries. In 1988, the product was jointly registered and listed in Japan by Roche Corporation and Fuji Corporation of Japan. [0005] Aniracetam is a new brain function improving drug. According to foreign clinical reports, it is mainly used for mental and behavioral disorders and senile dementia in patients with sequelae of cerebrovascular diseases. The Shanghai Institute of Materia Medica...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/4015A61K9/08A61P25/00A61P25/28
Inventor 朱嘉晖马奇明
Owner CHANGYUAN BIOLOGICAL PHARMA TECH WUXI
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