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 soli

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

Example Embodiment

[0030] Example 1

[0031] Take 17 parts of absolute ethanol, add 1 part of olaamide chemical raw material (provided by Chongqing Fuan Pharmaceutical Co., Ltd., purity 99.5%) and 5 parts of hydroxypropyl methylcellulose phthalate while stirring (Provided by Guangzhou Shuoheng Biological Technology Co., Ltd.), stir to dissolve, and then spray drying in a spray dryer (Huawei Technology Co., Ltd.). The inlet air temperature of spray drying is 145℃~147℃, and the outlet temperature is 79 ~81°C; crush the dried olaamide solid dispersion to obtain it.

[0032] Refer to the preparation method of Example 1, and run Examples 2-5 according to the parameters of Table 1 below to prepare a solid dispersion of olaamide. All the olaamide chemical raw materials used are 1 part.

[0033] Table 1 Preparation of olaamide solid dispersion

[0034]

[0035]

Example Embodiment

[0036] Example 6

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

[0038] ①Simulated gastric juice

[0039] Measure 900ml of 0.1mol / L hydrochloric acid solution and pour it into the dissolution cup. Heat to keep the solution temperature at 37±0.5°C. Quantitatively and accurately weigh 6 samples of the olaamide solid dispersion in Example 1-5 and put them into the rotating basket. , Start the machine at 100rpm, take samples at 10min, 30min, 60min, 90min, 120min respectively, and filter through 0.8um microporous water phase filter membrane. From sampling to filtration is completed within 30s, the sample is measured at 276nm wavelength Absorbance, and use the corresponding solvent as a blank control, and calculate the dissolution percentage of olaamide according to the external standard method. The release of olaamide solid dispersion in simulated gastric...

Example Embodiment

[0048] Example 7

[0049] Recipe: 59g olaamide solid dispersion prepared in Example 1, 10g pregelatinized starch, 12g sodium carboxymethyl starch, 8g low-substituted hydroxypropyl cellulose, 8g polyvinylpyrrolidone, 1g xylitol, 2g micronized silica gel .

[0050] Preparation:

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

[0052] (2) Mixing and granulation: Add the sieved olaamide solid dispersion, filler, and disintegrant into the wet granulator to mix evenly, turn on the stirring paddle and mix for 5 minutes; stop and add the adhesive at one time (Use ethanol to make 20% polyvinylpyrrolidone ethanol solution), start the stirring paddle, and the granulating paddle is mixed to prepare the soft material for 7 minutes, and the material is discharged when the particle size...

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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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