Piracetam freeze-dried powder injection for injection and preparation method thereof

A technology of piracetam and piracetam, which is applied in the field of medicine, can solve the problems that piracetam powder injection contains impurities, affects product stability, and affects medicinal effects, and achieves good product stability and medicinal effects Good, high-purity effect

Inactive Publication Date: 2014-09-03
HAINAN GENERAL & KANGLI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the medical field, the common form of piracetam for injection is injection solution. Considering the storage period and the convenience of transportation, it is necessary to prepare piracetam into powder injection. However, the existing preparation metho

Method used

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Embodiment Construction

[0010] The preparation method of piracetam freeze-dried powder for injection of the present invention is further described in conjunction with specific examples now, specifically as follows:

[0011] In a specific embodiment of the present invention, the preparation method of the piracetam freeze-dried powder injection for injection comprises the following steps: (1) first adding the piracetam to water for injection with a total preparation amount of 80% After dissolving in the medium, add the water for injection to the full amount to make a piracetam solution, then add 0.05% activated carbon and stir at room temperature for 30 minutes, filter until clear, and filter through a filter membrane with a micropore of 0.22 μm to obtain filtrate A (2) the filtrate A in the step (1) is detected through the pH value, and the filtrate A whose pH value meets the injection requirements is freeze-dried in a freeze dryer to make a freeze-dried powder B; (3) The freeze-dried powder B in step...

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PUM

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Abstract

The invention discloses a preparation method of a piracetam freeze-dried powder injection for injection. The preparation method comprises the following steps: 1, adding piracetam into injection water to dissolve, adding 0.05% active carbon to stir for 30 minutes at the room temperature and filter, subsequently filtering the injection water into a filtrate A through a filtration membrane with micro pore diameter being 0.22 micron; 2, detecting PH value of the filtrate A in the step 1, carrying out freeze drying on the filtrate A with the PH value meeting the injection requirements in a freeze dryer, namely putting a tube-type bottle filled with the filtrate A on a plate layer of the freeze dryer to carry out heat preservation for 6-7 hours at the temperature being 45 DEG C below zero; opening a vacuum pump, increasing the temperature of the plate layer to 0 DEG C and carrying out heat preservation for 30 hours when a vacuum degree is less than 10 Pa, increasing the temperature of the plate layer to 35 DEG C and carrying out heat preservation for 30 hours when the temperature in the tube-type bottle is close to the temperature of the plate layer, ending freeze-drying to prepare the freeze-dried powder B when the temperature in the tube-type bottle reaches 35 DEG C; (3) crushing the freeze-dried powder B in the step (2) in the environment with the humidity being less than 50%, sieving powder through a 30-mesh sieve after crushing, and carrying out aseptic packaging, bundling cover and packaging.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a piracetam freeze-dried powder for injection and a preparation method thereof. Background technique [0002] Piracetam is a white crystalline powder, odorless, bitter, soluble in water and slightly soluble in ethanol. It is a GABA analog, which can activate, protect and repair brain cells, increase the ATP / ADP ratio in the brain, promote the absorption of amino acids and phospholipids, protein synthesis and glucose utilization. No sedative, anticholinergic, antihistamine effect, used for senile mental decline syndrome, senile dementia, cerebral arteriosclerosis, memory and thinking function decline caused by cerebrovascular accident, thinking disorder caused by carbon monoxide poisoning, children's mental decline Wait. [0003] Due to its good physical and chemical properties, piracetam has been developed into various preparations, including tablets, capsules, granules, oral ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4015A61J3/02A61P25/28A61P9/10
Inventor 王志涛林小雪张丽华
Owner HAINAN GENERAL & KANGLI PHARMA
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