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

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 ...

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 method is to directly prepare piracetam Piracetam solution is freeze-dried to make powdered piracetam powder injection, so the prepared piracetam powder injection contains impurities, which affect the stability of the product and thus affect the medicinal effect