Preparation method of oral oxiracetam preparation suitable for old people to take

Abstract

The invention provides a preparation method of an oral oxiracetam preparation suitable for old people to take. Medicines and auxiliary materials are reasonably compatible and are granulated and tableted through a fluidized bed to prepare the preparation, the preparation can quickly disintegrate in the oral cavity under the waterless condition (or under the condition that only a small amount of water exists) and enter the digestive tract with swallowing actions, is consistent with a common tablet in the body about behaviors and is very suitable for old patients difficulty in swallowing. The prepared orally disintegrating oxiracetam tablet is reasonable in composition, prepared fluidized bed granules are thin, small and uniform, the angle of repose ranges from 30 degrees to 35 degrees, the liquidity is good, tablets do not break or is not softened or sticky, astringent and odd flavor phenomena do not occur in the tableting process, and the hardness of the prepared disintegrating oxiracetam tablet is 35-50 N. The disintegrating time limit is 30-40 S, the taste is better, no gravel feeling exists, the dissolution rate accumulated within 20 minutes exceeds 80%, and the oral oxiracetam preparation does not need special production conditions, has the advantages of being low in production cost and convenient to carry, store, transport and take, improves the taking compliance of patients and has a higher practical value.

Description

technical field [0001] The invention relates to oral preparations of oxiracetam, in particular to a preparation method of orally disintegrating oxiracetam tablets. Background technique [0002] Oxiracetam, whose chemical name is 4-hydroxy-2-oxo-1-pyrrolidineacetamide, was synthesized in 1974 by Italy Spike Chem Company, and was developed and marketed in 1987 as a drug that promotes learning and memory ability. A new type of central nervous system drug, clinically mainly used to treat senile dementia, multi-infarct dementia agent neurosis, brain trauma, encephalitis and other diseases caused by brain insufficiency and memory impairment. At present, 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] Regarding oxiracetam preparations, there are mainly injections, capsules and ordinary tablets in clinical practice. Injections enter the human body directly and quickly without the pr...

AI Technical Summary

Problems solved by technology

People such as Wang Lijiang disclosed a kind of oxiracetam levorotatory orally disintegrating tablet in Chinese patent CN101766595A, with levoracetam raw material, sodium carboxymethyl starch, croscarmellose sodium and other auxiliary materials with water Adhesive obtained; when repeating the patent, it was found that due to the excellent water solubility and strong hygroscopicity of levo-oxiracetam, the material is easy to form agglomerates during the wet granulation process, and most of the material sticks to the wall of the granulation pot , causing uneven particles, increasing the difficulty of granulation, it is difficult to obtain particles with uniform mixing and narrow particle size distribution, and poor compressibility, which is not conducive to the production of preparations

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