Easy-to-administrate oxiracetam granular formulation and preparation method

A technology of granule preparation and formulation, which is applied in the field of medicine and can solve problems such as inability to meet the clinical needs of patients

Active Publication Date: 2010-11-17
CSPC OUYI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the course of clinical use, there are often feedback information about coughing and choking events after taking oxiracetam capsules. Therefore, the formulation design and improvement of oxiracetam is of great significance. Oral preparations are only in the form of capsules, which cannot meet the clinical needs of most patients

Method used

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  • Easy-to-administrate oxiracetam granular formulation and preparation method
  • Easy-to-administrate oxiracetam granular formulation and preparation method
  • Easy-to-administrate oxiracetam granular formulation and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Oxiracetam granule preparation, the content of each component in 1000 bags is calculated in grams:

[0046] Oxiracetam 200g

[0047] Mannitol 165g

[0048] Aspartame 1.875g

[0049] Sunset Yellow 0.075g

[0050] Powder essence 0.375g

[0051] 15% PVP aqueous solution appropriate amount

Embodiment 2

[0053] Oxiracetam granule preparation, the content of each component in 1000 bags is calculated in grams:

[0054] Oxiracetam 400g

[0055]Mannitol 330g

[0056] Aspartame 3.75g

[0057] Sunset Yellow 0.15g

[0058] Powder essence 0.75g

[0059] 15% PVP aqueous solution appropriate amount

Embodiment 3

[0061] Oxiracetam granule preparation, the content of each component in 1000 bags is calculated in grams:

[0062] Oxiracetam 800g

[0063] Mannitol 660g

[0064] Aspartame 7.5g

[0065] Sunset Yellow 0.3g

[0066] Powder essence 1.5g

[0067] 15% PVP aqueous solution appropriate amount

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Abstract

The invention relates to an easy-to-take oxiracetam particle preparation and a preparation method, which pertains to the technical field of medicine and is used for solving the problems of stability and inconvenient administration. The preparation comprises oxiracetam nano-particles and pharmaceutical excipients, the mix ratio by weight units of the main drug oxiracetam and the pharmaceutical excipients after the improvement is 1.195: 1, the pharmaceutical excipients are composed of mannitol, asipatan, sunset yellow and powdered fragrances, and the mix ratio by weight units of the ingredientsof the pharmaceutical excipients is 440: 5: 0.2: 1. The selection of the excipients in a formula of the preparation of the invention, the mix ratio of the main drug and the excipients and the mix ratio relationship among the excipients are accurate and reasonable, thus being characterized by easy water solubility, better smell and convenient administration, more particularly, the administration by the patients with difficult swallow of other oral preparations or the patients with senile dementia who are not cooperative for injection drug delivery. The preparation has stable quality and easy preservation, thus being applicable to the patients for long-term administration. The oxiracetam particle preparation of the invention has simple preparation process, lower production cost and easy implementation.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method, in particular to an easy-to-take oxiracetam granule preparation for treating diseases of the central nervous system, which belongs to the technical field of medicine. Background technique [0002] Oxiracetam is a synthetic cyclic derivative of hydroxyaminobutyric acid (GABOB), which acts on the central nervous system and is mainly distributed in the cerebral cortex and hippocampus. It can activate, protect or promote the functional recovery of nerve cells, Improving memory and learning functions in people with intellectual disabilities. Oxiracetam indications are common diseases among the elderly, mainly manifested as poor energy concentration, loss of calculation ability, difficulty in language expression, memory loss in severe cases, inability to take care of themselves, inability to control emotions, etc. Defects, intelligence impairment syndrome, amnesia syndrome, pers...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/4015A61K9/16A61K47/10A61P25/28A61P25/00
Inventor 郭卫芹张育李国聪
Owner CSPC OUYI PHARM CO LTD
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