L-oxiracetam freeze-dried composition for injection and preparation method thereof

Abstract

The invention discloses an L-oxiracetam freeze-dried composition for injection and a preparation method thereof. The freeze-dried composition contains the following raw materials and auxiliary materials (by weight): 50-60% of L-oxiracetam, 20-25% of L-serine, 10-17% of mannitol, 5-7% of monosodium glutamate and 5-10% of sodium bisulfite. The preparation method of the L-oxiracetam freeze-dried composition for injection comprises steps of concentrated mixing, diluted mixing, freeze drying, capping, etc. By the utilization of a specific excipient combination, the prepared L-oxiracetam freeze-dried composition has a fixed shape. There is no eruption phenomenon during the freeze-drying process. In addition, the product has good stability. After the product is dissolved in a glucose injection or a sodium chloride injection to prepare an intravenous drip solution, insoluble particles are remarkably reduced. The preparation method helps raise drug use safety and reduce adverse drug reaction.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a levoxiracetam freeze-dried composition for injection and a preparation method thereof. Background technique [0002] Nootropic drug, also known as brain activator, is a new type of central nervous system drug that promotes learning and enhances memory. Nootropic drugs are required to selectively act on the cerebral cortex, and have the characteristics of selectively activating, protecting and promoting the recovery of damaged nerve cell functions. The difference from other neurological drugs is that their above-mentioned effects do not pass through the reticular system or the olfactory bulb, but directly act on the cortex. It neither affects behavior nor has sedative and exciting effects, so this class of drugs has attracted widespread attention and interest, and the demand for this class of drugs is also increasing day by day. [0003] Oxiracetam (oxiracetam, CAS No.: 626...

AI Technical Summary

Problems solved by technology

[0005] However, the existing levoxiracetam freeze-dried powder for injection has no fixed shape, is not easy to form a skeleton, is prone to spray bottle phenomenon during the freeze-drying process, and has the problem of poor product stability. Before clinical use, it needs to be dissolved in 5% Glucose Injection or 0.9% Sodium Chloride Injection 100 ~ 250ml, prepared as an intravenous infusion solution, levoxiracetam freeze-dried powder prepared as an intravenous infusion solution, with the prolongation of storage time The increase of insoluble particles increases, which brings great safety hazards to clinical use

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