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Dextrorotatory oxiracetam oral membrane and preparation method thereof

A technology of dextro-olamide and oral film, which is applied in the field of dextro-olamide oral film and its preparation, which can solve the problems of difficult control of disintegration time and tensile strength, low drug loading, and restrictions on oral film In order to improve the bioavailability, the preparation method is simple, and the elimination effect can be avoided.

Inactive Publication Date: 2018-11-13
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although oral film has many advantages, the limitations of film-forming materials and preparation technology lead to low drug loading, and the disintegration time and tensile strength are not easy to control, which restricts the development and application of oral film

Method used

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  • Dextrorotatory oxiracetam oral membrane and preparation method thereof
  • Dextrorotatory oxiracetam oral membrane and preparation method thereof
  • Dextrorotatory oxiracetam oral membrane and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Prescription: 30-68 parts of dextro-olamide, 24-52 parts of film-forming material (acrylate and sodium alginate, the mass ratio of acrylate to sodium alginate is 1~3:1), filler 0-20 Parts, 5-10 parts of plasticizer (propylene glycol, triethyl citrate, wherein the mass ratio of propylene glycol to triethyl citrate is 1:1 to 3), 0.5-3.0 flavoring agent.

[0032] Preparation:

[0033] (1) Dissolve the film-forming material with absolute ethanol and remove the bubbles to obtain a uniform viscous liquid;

[0034] (2) Disperse the plasticizer, filler, and flavoring agent uniformly into a dispersion with absolute ethanol;

[0035] (3). Add the dispersion of step (2) to the viscous liquid of step (1), add dextro-olamide to disperse evenly, and then let it stand to remove air bubbles;

[0036] (4) The viscous liquid after removing bubbles is coated, dried, and peeled off with a medicinal film coating film dryer; the coating speed of the medicinal film dryer is 55-85cm / min, and the drying...

Embodiment 2

[0038] Prescription: 30-68 parts of dextro-olamide, 24-52 parts of film-forming materials (acrylate, hydroxypropyl methyl cellulose and sodium carboxymethyl cellulose, including acrylate, hydroxypropyl methyl cellulose, The mass ratio of sodium carboxymethyl cellulose is 2~4:1~3:1), 0-20 parts of filler, 5-10 parts of plasticizer (glycerin and dibutyl phthalate, among which glycerin and ortho The mass ratio of dibutyl phthalate is 2~3:1), 0.5-3.0 flavoring agent.

[0039] Preparation:

[0040] (1) Dissolve the film-forming material with absolute ethanol and remove the bubbles to obtain a uniform viscous liquid;

[0041] (2) Disperse the plasticizer, filler, and flavoring agent uniformly into a dispersion with absolute ethanol;

[0042] (3). Add the dispersion liquid of step (2) to the viscous liquid of step (1), add dextro-olamide to disperse evenly, and then stand to remove air bubbles;

[0043] (4) The viscous liquid after removing the bubbles is coated, dried and peeled off with a ...

Embodiment 3

[0045] Prescription: 60 g of dextro-olamide, 6 g of low-substituted hydroxypropyl cellulose, 18 g of acrylate (No. I), 6 g of sodium alginate, 3 g of propylene glycol, 6 g of triethyl citrate, and 1 g of xylitol.

[0046] Preparation:

[0047] (1) Dissolve the film-forming materials (acrylate and sodium alginate) with absolute ethanol and remove bubbles to obtain a uniform viscous liquid;

[0048] (2) Disperse the plasticizer (propylene glycol and triethyl citrate), filler (low-substituted hydroxypropyl cellulose) and flavoring agent (xylitol) uniformly into a dispersion with absolute ethanol;

[0049] (3) Add the dispersion of step (2) to the viscous liquid of step (1), add dextro-olamide to disperse uniformly, and then stand to remove air bubbles;

[0050] (4) Coat the viscous liquid after removing the bubbles with a medical film coating film dryer at a coating speed of 65cm / min, then dry it at 67-68°C, peel off and cut it.

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Abstract

The invention provides a dextrorotatory oxiracetam oral membrane which is prepared from a membrane forming material containing acrylate together with a plasticizer, a filler, a corrigent and dextrorotatory oxiracetam by a coating method. Since the membrane forming material containing acrylate is mixed with a particular quantity of raw materials such as dextrorotatory oxiracetam, the filler and theplasticizer to achieve an synergistic effect, the stripping performance is improved while problems such as membrane adhesion and soft texture are solved, and thus, quality of the product is improved.The dextrorotatory oxiracetam oral membrane has uniform and complete appearance, uniform color, and consistent thickness, stable physical and chemical properties, short time for disintegration, quickdissolving and quick action; the preparation method is simple, can be implemented without any large-size industrial equipment, and is suitable for industrial production.

Description

Technical field [0001] The invention relates to a dextro-olaamide pharmaceutical composition, in particular to a dextro-olaamide oral film and a preparation method thereof. Background technique [0002] Olamide (CAS No.: 62613-82-5), clinically mainly used to treat neurological deficits, memory and cognitive impairment caused by stroke and brain trauma; mild to moderate Alzheimer's disease, vascular dementia , Mixed dementia, etc. Olamide can pass through the blood-brain barrier, mainly distributed in the septum, hippocampus, cortex and striatum, acting on aspartate (NMDA) receptors, and stimulating protein kinase C through its agonistic effect on the cholinergic system (PKC), improving brain energy metabolism, etc., is beneficial to improving the cognitive and behavioral activities of the brain in patients with dementia, such as memory, orientation, and abstraction. It can also promote the plasticity of the synapses of the cerebral cortex connecting fibers and mobilize the futu...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4015A61K47/14A61K47/38A61K47/36A61K47/10A61P25/08
CPCA61K9/006A61K9/7007A61K31/4015A61K47/10A61K47/14A61K47/36A61K47/38
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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