Levo-oxiracetam freeze-dried powder for injection

Abstract

The invention discloses a levo-oxiracetam freeze-dried powder for injection. The freeze-dried powder contains the following raw and auxiliary materials by mass: 1 part of levo-oxiracetam, 0.4-0.6 partof methionine, 0.5-0.9 part of lactose, 0.2-0.4 part of triethanolamine, 0.01-0.02 part of Tween 80, and 0.01-0.03 part of phenol. The invention utilizes specific excipient combination and freeze-drying curve, the sublimation temperature of a secondary drying stage is raised, the preparation production cycle is shortened, powder scattering phenomenon does not occur, the content and other indicators all meet the requirements, the product has good clarity that is lower than a 0.5# standard turbidity solution, also has strong antibacterial properties, and is qualified in aseptic inspection.

Description

Technical field [0001] The invention belongs to the field of pharmacy, and specifically relates to a lyophilized L-Oxiracetam powder for injection. Background technique [0002] Nootropics, also known as brain activators, are a new type of central nervous system drug that promotes learning and enhances memory. Nootropic drugs require selective action on the cerebral cortex and have the characteristics of selective activation, protection and promotion of the functional recovery of damaged nerve cells. The difference from other neuropharmaceuticals is that their above-mentioned effects do not pass through the reticular system or olfactory bulb, but directly act on the cortex. Neither affects behavior, nor does it have a sedative and excitatory effect. Therefore, this type of drug has attracted widespread attention and interest, and the demand for this type of drug is also increasing. [0003] Oxiracetam (CAS No.: 62613-82-5) is chemically named 4-hydroxy-2-oxo-1-pyrrolidine acetami...

AI Technical Summary

Problems solved by technology

[0005] However, during the preparation process of the existing levoxiracetam freeze-dried powder for injection, the inventors found that in the secondary drying stage, the sublimation temperature is low, and the temperature cannot be higher than 20°C, which greatly prolongs the production cycle of the preparation. , if the temperature in the secondary drying stage is increased, powder scattering will occur in the formulation, its content will drop significantly, and the product clarity will be unqualified

In addition, the existing levoxiracetam freeze-dried powder for injection has relatively poor antibacterial properties, which may easily lead to unqualified sterility tests

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