Levo-oxiracetam particle and preparation method thereof

A granule and prescription technology, applied in the field of levooxiracetam granules and the preparation thereof, can solve the problems of difficult particle size control, easy adhesion and blockage, strong hygroscopicity of granules, etc., and achieves a simple and feasible preparation process, and is not easy to absorb moisture. The effect of uniform particle size of lumps and particles

Active Publication Date: 2017-12-26
武汉恒信源药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The existing oxiracetam granules mainly have technologies such as large increase of impurities during the preparation process, more particle powder layers, difficult control of particle size, poor stability during storage, strong hygroscopicity of particles, easy adhesion and caking, and short shelf life. question

Method used

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  • Levo-oxiracetam particle and preparation method thereof
  • Levo-oxiracetam particle and preparation method thereof
  • Levo-oxiracetam particle and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A levo-oxiracetam granule, prepared according to the following steps:

[0026]

[0027] Preparation process:

[0028] 1. Pretreatment of raw and auxiliary materials: Take the prescribed amount of levoxiracetam, L-cysteine, mannitol, microcrystalline cellulose, sodium carboxymethyl cellulose, and lactose in a universal grinder, and grind through 100 Mesh sieve, spare;

[0029] 2. Granulation: Take the mixed powder obtained after the pretreatment, place it in a wet granulator, add starch slurry with a mass fraction of 6%, start the granulator (install a 18-mesh nylon sieve), and start granulation;

[0030] 3. Drying: Put the wet granules into the fluidized bed, set the temperature of the hot bed at 50°C to 70°C, and start drying; observe the boiling and blasting conditions of the granules at any time to prevent the granules from sticking to the bottom of the pot, causing coking or gelatinization of the granules. The drying time is 50-55 minutes, and the moisture cont...

Embodiment 2

[0077] A levo-oxiracetam granule, prepared according to the following steps:

[0078]

[0079] Preparation process: prepared according to the preparation process of Example 1. Carry out the test by the test method of embodiment 1, the Hughes angle test measurement result shows that this product granule fluidity is good, and the Hughes angle is lower than 37 °, and the loading difference test shows that the loading difference of this product is less than 5%, and the loading of this product Stable, controllable, the stability test results show that the quality of the samples in accelerated June is stable, and the quality of the long-term 24 months is stable, so the validity period of this product is at least 24 months. The test results of the influence of product prescription on the increase of impurities in the preparation process show that the impurities in the preparation process The increase is small, and the related substances only increase by 0.02% in the preparation pr...

Embodiment 3

[0081] A levo-oxiracetam granule, prepared according to the following steps:

[0082]

[0083] Preparation process: prepared according to the preparation process of Example 1. Carry out the test by the test method of embodiment 1, the Hughes angle test measurement result shows that this product granule fluidity is good, and the Hughes angle is lower than 35 °, and the loading difference test shows that the loading difference of this product is less than 4%, and the loading of this product Stable, controllable, the stability test results show that the quality of the samples in accelerated June is stable, and the quality of the long-term 24 months is stable, so the validity period of this product is at least 24 months. The test results of the influence of product prescription on the increase of impurities in the preparation process show that the impurities in the preparation process The increase is small, and the related substances only increase by 0.03% in the preparation pr...

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Abstract

The invention relates to a levo-oxiracetam particle. The levo-oxiracetam particle is characterized by being prepared from the following raw and auxiliary materials by weight: 1 part of levo-oxiracetam, 0.5-1.0 part of L-cysteine, 0.7-1.3 parts of mannitol, 0.5-1.2 parts of microcrystalline cellulose, 1.0-1.5 parts of sodium carboxymethyl cellulose, 1.1-1.5 parts of lactose, 0.12-0.16 part of talcum powder, 0.6-1.2 parts of polyethylene glycol 4000, 0.7-1.3 parts of hydroxypropyl methylcellulose, and 8-15 parts of a starch slurry with a volume fraction of 6%-8%. The levo-oxiracetam particle prepared according to the invention has the advantages of small impurity increase of only 0.03% during preparation, small powder layer content, uniform particle size, good fluidity, a repose angle of less than 37 degrees, a load difference of less than 5%, good storage process stability, difficult moisture absorption and caking, and a shelf life up to 24 months.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam granule and a preparation method thereof. Background technique [0002] Oxiracetam (oxiracetam, CAS No.: 62613-82-5) chemical name is 4-hydroxy-2-oxo-1-pyrrolidineacetamide, which was synthesized for the first time in 1974 by the Italian company ISFS.P.A. Oxygen nootropic drug (compound disclosed in US4118396), is a derivative of cyclic GABOB, which can promote the synthesis of phosphorylcholine and phosphorylethanolamine, promote brain metabolism, pass through the blood-brain barrier, and have a stimulating effect on specific central nervous system. It can improve intelligence and memory, and also has good curative effect on cerebrovascular disease, traumatic brain injury, brain tumor, intracranial infection, brain degenerative disease, etc., and the drug has extremely low toxicity, no mutagenic, carcinogenic and reproductive toxicity. The people such as...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4015A61P25/28A61P25/00A61P35/00
CPCA61K9/1652A61K31/4015
Inventor 叶雷
Owner 武汉恒信源药业有限公司
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