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Oxiracetam oral disintegrating preparation and preparation method thereof

An olamide and oral disintegration technology, used in pill delivery, pharmaceutical formulations, cardiovascular system diseases, etc., to achieve the effects of increased absorption, moderate hardness and good dispersion effect

Inactive Publication Date: 2018-11-02
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to solve the shortcomings in the prior art, the object of the present invention is to provide an orally disintegrating preparation containing olaamide solid dispersion, which does not have difficulty in swallowing and coughing during taking, and is very suitable for children with difficulty in swallowing or elderly patients

Method used

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  • Oxiracetam oral disintegrating preparation and preparation method thereof
  • Oxiracetam oral disintegrating preparation and preparation method thereof
  • Oxiracetam oral disintegrating preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Get 17 parts of absolute ethanol, under stirring state, add 1 part of Olamide chemical bulk drug (provided by Chongqing Fuan Pharmaceutical Co., Ltd., purity 99.5%) and 5 parts of hydroxypropyl methylcellulose phthalate (provided by Guangzhou Shuoheng Biological Technology Co., Ltd.), stirred until dissolved, and then spray-dried in a spray dryer (Huawei Technology Co., Ltd.). ~81°C; grind the dried olaamide solid dispersion to obtain the product.

[0032] Referring to the preparation method of Example 1, run Examples 2-5 according to the parameters in Table 1 below to prepare the solid dispersion of alamide. All the raw materials of Olamide used are 1 part.

[0033] Table 1 Preparation of Olamide Solid Dispersion

[0034]

[0035]

Embodiment 6

[0037] The release of the orally disintegrating preparation containing olaamide solid dispersion in gastric juice and intestinal juice of the present invention was investigated.

[0038] ①Simulated gastric juice

[0039] Measure 900ml of 0.1mol / L hydrochloric acid solution, pour it into the dissolution cup, heat to keep the solution temperature at 37±0.5°C, quantitatively and accurately weigh 6 parts of the solid dispersion samples of alamide in Examples 1-5, and put them into the basket , start the machine to run at a speed of 100rpm, take samples at 10min, 30min, 60min, 90min, and 120min respectively, and filter through a 0.8um microporous water-phase filter membrane, from sampling to filtration is completed within 30s, and the sample is measured at a wavelength of 276nm Absorbance, and using the corresponding solvent as a blank control, the dissolution percentage of olaamide was calculated by the external standard method. The drug release of olaamide solid dispersion in si...

Embodiment 7

[0049] Prescription: 59g of the solid dispersion of alaramide prepared in Example 1, 10g of pregelatinized starch, 12g of sodium carboxymethyl starch, 8g of low-substituted hydroxypropyl cellulose, 8g of polyvinylpyrrolidone, 1g of xylitol, and 2g of micropowdered silica gel .

[0050] Preparation:

[0051] (1) Material sieving: pass the solid dispersion of oracamide, pregelatinized starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, polyvinylpyrrolidone, xylitol, and micropowdered silica gel through a 100-mesh sieve respectively, spare;

[0052] (2) Mixing and granulation: Add the sieved solid dispersion of oramide, filler, and disintegrating agent to the wet granulator and mix evenly, start the stirring paddle to mix for 5 minutes; (20% polyvinylpyrrolidone ethanol solution made of ethanol), start the stirring paddle, mix the granulating paddle to prepare soft material for 7 minutes, and discharge when the particle size is about 80 mesh; wherein, ...

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Abstract

The invention provides an oral disintegrating preparation containing oxiracetam solid dispersion. The oral disintegrating preparation is prepared by using the oxiracetam solid dispersion as an activeingredient, assisting with a carefully-selected excipient ratio and carrying out wet granulation and tableting; by controlling a series of parameters such as particle sizes of materials, temperature and charge, the problem that materials are easy to agglomerate due to large prescription amount of the oxiracetam as well as excellent water solubility and high moisture absorption is solved; meanwhile, the phenomenon of uneven particles caused by sticking of most materials on the wall is solved. The prepared oxiracetam particles have the advantages of fine and uniform particles, moderate hardness,small difference in tablet weight. The preparation method disclosed by the invention is simple and is suitable for industrial production.

Description

technical field [0001] The invention relates to an olaramide preparation, in particular to an orally disintegrating preparation and a preparation method thereof. Background technique [0002] Olamide (CAS No.: 62613-82-5), is mainly used clinically for the treatment of neurological deficits, memory and cognitive impairments caused by stroke, traumatic brain injury; mild to moderate Alzheimer's disease, vascular dementia , mixed dementia, etc. Olamide can pass through the blood-brain barrier, and is mainly distributed in the septum, hippocampus, cortex and striatum, acting on aspartic acid (NMDA) receptors, through the stimulatory effect on the cholinergic system, activating protein kinase C (PKC) plays a role in improving the energy metabolism of brain tissue. It is beneficial to improve the cognitive and behavioral activities of the brain such as memory, orientation, and abstract generalization in dementia patients. Damaged brain tissue reorganization and functional recon...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K9/16A61K31/4015A61K47/38A61P25/28A61P9/10
CPCA61K9/0056A61K9/1652A61K9/2054A61K9/2095A61K31/4015
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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