(S)-oxiracetam granule having good content uniformity, and preparation method thereof

Abstract

An (S)-oxiracetam granule having a good content uniformity is prepared from, by weight, 1 part of (S)-oxiracetam, 0.6-1.1 parts of L-cysteine, 1.0-1.6 parts of mannitol, 0.7-1.2 parts of microcrystalline cellulose, 0.6-1.1 parts of carboxymethylcellulose sodium, 0.8-1.3 parts of lactose, 0.5-1.1 parts of sorbitol, 0.11-0.19 part of talcum powder, 0.8-1.6 parts of polyethylene glycol 4000, 0.7-1.5 parts of hydroxypropyl methylcellulose, 2-6 parts of ethanol with the volume fraction being 30-50%, 1.1-1.7 parts of honey and 10-16 parts of ethanol with the volume fraction being 70-90%. The (S)-oxiracetam granule prepared in the invention has the advantages of small impurity increasing amount being 0.04% in the preparation process, no adhesion to a screen during granulation, easiness in granulation, small quantity of powder layers, uniform particle size, good fluidity, realization of the Xiuzi angle being less than 36 DEG and the loading difference being within -5% to 5%, good content uniformity, realization of the content RSD of multiple points being less than 2%, good stability during storage, no moisture absorption caking, and long shelf life reaching up to 24 months.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam granule with good content uniformity and a preparation method thereof. Background technique [0002] Oxiracetam (S-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 has the function of activating, protecting or promoting nerve cells. Functional recovery can improve the memory and learning functions of patients with mental retardation, and the drug itself has no direct vasoactive or central excitatory effect, and its effect on learning and memory is a lasting promotion effect. [0003] The drug was launched in Italy in 1987, and the listed dosage forms are tablet, 800mg; capsule, 800mg; injection, 5ml: 1g. At present, only oxiracetam capsules and injections are on the market in China, and the main active ingredien...

AI Technical Summary

Problems solved by technology

[0004] The main problems of existing levoxiracetam granules are that the impurities increase during the preparation process, the granulation process is easy to stick to the screen, and the granulation is difficult. The main drug is not easy to mix evenly during the mixing process, and the content uniformity is poor. Difficult to control particle size, poor stability during storage, strong hygroscopicity of particles, easy to stick and agglomerate, short shelf life and other technical problems

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