Preparation method of levo-oxiracetam lyophilized powder

Abstract

The invention discloses a preparation method of levo-oxiracetam lyophilized powder. The levo-oxiracetam lyophilized powder is prepared from the following raw materials and auxiliary materials in percentage by weight: 50-59% of levo-oxiracetam, 20-25% of L-serine, 10-17% of mannitol, 5-7% of polyethylene glycol 2000, 5-10% of sodium hydrogen sulfite and 0.1-0.5% of phenol; and the levo-oxiracetam lyophilized powder is obtained by carrying out the steps of thick mixing, dilute mixing, freeze drying and capping. The preparation method disclosed by the invention has the advantages that specific excipient combination is utilized, and then a specific freeze drying technology is combined, so that the prepared levo-oxiracetam lyophilized powder has fixed geometry, no phenomena such as dry shrinkage and bubbling are caused in a freeze drying preparation process, product uniformity is good, upper and lower layers are consistent in character, antibacterial property is strong, sterility test is qualified, product stability is good, and insoluble particles are obviously reduced.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a preparation method of levoxiracetam freeze-dried powder. Background technique [0002] Oxiracetam is a synthetic cyclic derivative of hydroxyaminobutyric acid (BABOB), which is only used in the central nervous system, mainly distributed in the cerebral cortex and hippocampus, and can activate, protect or promote the functional recovery of nerve cells , to improve the memory and learning function of patients with mental retardation, and the drug itself has no direct vasoactive activity, nor does it have a central excitatory effect, and the effect on learning and memory ability is a lasting promotion effect. [0003] The drug was launched in Italy in 1987, and the listed dosage forms are tablets, 800mg; capsules, 800mg; injection, 1g / 5ml. At present, only oxiracetam capsules and injections are on the market in China, and the main active ingredients used are racemates. Ye Lei...

AI Technical Summary

Problems solved by technology

[0004] However, the existing levoxiracetam freeze-dried powder for injection has problems such as no fixed shape, difficulty in forming a skeleton, easy drying shrinkage and bubbling, poor product uniformity, inconsistent properties of the upper and lower layers, and poor product stability. Before clinical use, it needs to be dissolved in 100-250ml of 5% glucose injection or 0.9% sodium chloride injection to prepare an intravenous infusion solution. Levoxiracetam lyophilized powder is prepared as an intravenous infusion solution Finally, as the storage time prolongs, the insoluble particles increase in size, which brings great safety hazards to clinical use.

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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