Preparation method of L-oxiracetam freeze-dried powder

Abstract

The invention discloses a preparation method of L-oxiracetam freeze-dried powder. The L-oxiracetam freeze-dried powder contains the following raw materials and auxiliary materials (by weight): 50-59% of L-oxiracetam, 20-25% of L-serine, 10-17% of mannitol, 5-7% of monosodium glutamate, 5-10% of sodium bisulfate and 0.1-0.5% of phenol. The L-oxiracetam freeze-dried powder is prepared by steps of concentrated mixing, diluted mixing, freeze drying and capping. By the utilization of specific excipient combination and with the cooperation of a specific freeze-drying technology, the prepared L-oxiracetam freeze-dried powder has a fixed shape. There is no eruption phenomenon during the freeze-drying process. The product has good homogeneity, trait uniformity of upper and lower layers and strong bacterinertness, and is aseptic and qualified after examination. In addition, the product has good stability, and insoluble particles are remarkably 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 occurrence of spray bottle phenomenon in the freeze-drying process, poor product uniformity, inconsistent properties of the upper and lower layers, and the like. The problem of poor 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 After the solution is injected, the insoluble particles increase with the prolongation of the storage time, 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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