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Pharmaceutical composition for treatment of senile dementia and preparation method thereof

A composition and drug technology, applied in the directions of drug combination, drug formula, drug delivery, etc., can solve the problems of instability, acceleration, and unfavorable disease treatment, and achieve the effect of small difference in loading and good content uniformity.

Inactive Publication Date: 2019-04-30
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Levo-oxiracetam contains an amide bond in its molecule, which can be hydrolyzed into carboxylic acid and ammonia or amine. Acid, alkali and heat can accelerate its hydrolysis. Oral preparations of levo-oxiracetam are unstable in the stomach. The prolongation of the drug is decomposed by gastric acid, which is not conducive to the treatment of the disease

Method used

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  • Pharmaceutical composition for treatment of senile dementia and preparation method thereof

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preparation example Construction

[0019] The preparation method of the above-mentioned pharmaceutical composition for treating senile dementia is characterized in that the pharmaceutical composition comprises levo-oxiracetam granules, and the levo-oxiracetam granules include an inner core layer and an outer core layer; Oxiracetam and inner core layer auxiliary material, the outer core layer includes outer core layer material and outer core layer auxiliary material, wherein levo-oxiracetam is 45-78%, inner core layer auxiliary material is 15-32%, and outer core layer material is 5- 25%, 0.1-4% of the excipients of the outer core layer; the excipients of the inner core layer are xanthan gum, sodium alginate, methyl cellulose, hydroxyethyl cellulose, chitin, microcrystalline cellulose, povidone or hydroxy Any one or several compositions of propyl methylcellulose; the material of the outer core layer is a mixture of polyacrylic resin and cellulose acetate phthalate, wherein the polyacrylic resin and cellulose aceta...

Embodiment 1

[0024] Prescription: Levoxiracetam 55g, microcrystalline cellulose 12g, hydroxypropyl methylcellulose 12g, polyacrylic resin Eudragit L100 15g, cellulose acetate phthalate 5g, micronized silica gel 1g.

[0025]Preparation process: Preparation of dry granules: Dissolving hydroxypropyl methylcellulose with an appropriate amount of ethanol with a concentration of 75%, and preparing a 15% hydroxypropyl methylcellulose ethanol solution with a mass fraction; Add hydroxypropyl methylcellulose ethanol solution to the mixture of oxiracetam and microcrystalline cellulose to make soft material, the soft material is passed through a sieve to make wet granules, and dried at a drying temperature of 50 °C and a drying time of 20 minutes to obtain dry Granules; fluidized bed coating: mix polyacrylic acid resin Eudragit L100, cellulose acetate phthalate, and micropowder silica gel evenly, dissolve with ethanol solution with a mass fraction of 80%, and prepare a coating solution with a mass frac...

Embodiment 2

[0027] Prescription: Levoxiracetam 45g, hydroxypropyl methylcellulose 32g, polyacrylic resin EudragitL10014g, cellulose acetate phthalate 7g, micronized silica gel 1g.

[0028] Preparation process: Preparation of dry granules: dissolving hydroxypropyl methylcellulose with ethanol with an appropriate concentration of 60%, and preparing a 20% hydroxypropyl methylcellulose ethanol solution with a mass fraction; Add hydroxypropyl methylcellulose ethanol solution to the tank to make soft material, the soft material is passed through a sieve to make wet granules, dry, the drying temperature is 45 ° C, and the drying time is 30 minutes to obtain dry granules; fluidized bed coating: Polyacrylic resin Eudragit L100, cellulose acetate phthalate, and micropowder silica gel were mixed uniformly, dissolved in an ethanol solution with a mass fraction of 95%, and prepared into a coating solution with a mass fraction of 15%, and ground through a colloid mill; then the prepared The dry granule...

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Abstract

The invention provides a pharmaceutical composition for treatment of senile dementia, wherein the pharmaceutical composition comprises levooxiracetam enteric-coated granules. The levooxiracetam enteric-coated granules take the combination of polyacrylic acid resin and cellulose acetate phthalate with a specific proportion as an enteric-coated coating material. The prepared levooxiracetam enteric-coated granules are released in intestinal juice, and the granules are spherical in appearance, have an angle of repose between 30 and 32 degrees, have the advantages of good fluidity, uniform granules, good content uniformity, and hard and heavy granules, have loading amount difference less than 2.5%, and have the dissolution rate higher than 99.0%. The preparation method is simple and suitable for industrialized production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition for treating senile dementia and a preparation method thereof. Background technique [0002] Alzheimer's disease is a degenerative disease of the central nervous system. Its onset is insidious and its course is chronic and progressive. It mainly manifests as neuropsychiatric symptoms such as progressive memory impairment, personality changes, and language barriers, which seriously affects social, occupational, and life functions. The etiology and pathogenesis of senile dementia have not yet been elucidated, and there is no specific therapy for the treatment. Symptomatic treatment is mainly used, including drug treatment to improve memory impairment, symptomatic improvement of mental symptoms, and good nursing to delay the progression of the disease. Among the therapeutic drugs, cholinesterase inhibitors and glutamate receptor antagonists are...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K47/32A61K47/38A61K31/4015A61P25/28
CPCA61K9/5026A61K9/5042A61K31/4015A61P25/28
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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