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Oxiracetam enteric-coated preparation and preparation method thereof

An enteric-coated preparation and enteric-coated technology, applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as poor product stability, burst release risk, and increased safety risk

Inactive Publication Date: 2019-05-07
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Injections enter the human body directly and quickly without the protection of normal physiological barriers of the human body. Therefore, if the dose is improper or the injection is too fast, or there is a problem with the quality of the drug, it may cause harm to the patient, and even cause irreparable consequences; In addition, injection pain, Cannot be administered by the patient himself, local induration of injection and vascular inflammation caused by intravenous injection are all important problems in clinical application
Most of the active ingredients of oxiracetam capsules currently on the market dissolve in the stomach. With the prolongation of the residence time, the amide bond in the oxiracetam molecule is destroyed by gastric acid, thereby greatly reducing the pharmacological activity. increased security risk
In addition, the currently marketed oxiracetam oral preparations are affected by various factors such as raw materials, preparation technology, and storage conditions, resulting in poor product stability, unstable pharmacological effects, and the risk of sudden release in clinical applications. A series of problems such as gender difference

Method used

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  • Oxiracetam enteric-coated preparation and preparation method thereof

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preparation example Construction

[0026] In some embodiments, the above-mentioned preparation method of oxiracetam oral powder preparation includes the step of preparing oxiracetam enteric-coated granules and passing the oxiracetam enteric-coated granules through an 80 mesh sieve, and then mixing them with fillers, flavoring After the agent is mixed evenly, the step of dispensing. The oxiracetam enteric-coated granules of the present invention are prepared by the following steps: uniformly mixing carrier materials, dissolving them in ethanol with a mass fraction of 50-90%, and preparing a carrier material ethanol solution with a mass fraction of 5-30%; Then add the ethanol solution of the carrier material to oxiracetam to make soft material, the soft material is sieved to make wet granules, and dry at a drying temperature of 30-60°C and a drying time of 10-60min to obtain dry granules; The coating material and the lubricant are mixed evenly, dissolved in an ethanol solution with a mass fraction of 50-90%, and ...

Embodiment 1

[0038] Preparation of oxiracetam enteric-coated sustained-release granules.

[0039]

[0040] Preparation:

[0041] (1) Ingredients: pass the crystalline form of oxiracetam, polyoxyethylene WSR N10, hydroxypropyl methylcellulose, Eudragit L100, ethylcellulose, and magnesium stearate through a 100-mesh sieve respectively, and set aside;

[0042] (2) Preparation of dry granules: mix hydroxypropyl methylcellulose and polyoxyethylene WSR N10 evenly, dissolve with an appropriate amount of ethanol with a concentration of 50%, and prepare a carrier material ethanol solution with a mass fraction of 20%; then crystallize Form Add carrier material ethanol solution to oxiracetam to make soft material, the soft material is passed through a sieve to make wet granules, and dry at a drying temperature of 55°C and a drying time of 20 minutes to obtain dry granules;

[0043] (3) Preparation of oxiracetam enteric-coated sustained-release granules: mix polyacrylic acid resin Eudragit L100, e...

Embodiment 2

[0049] Preparation of oxiracetam enteric-coated sustained-release granules.

[0050]

[0051] Preparation:

[0052] (1) Ingredients: pass the crystalline form oxiracetam, polyoxyethylene WSR N10, hydroxypropyl methylcellulose, Eudragit L100, ethylcellulose, and micropowder silica gel through a 100-mesh sieve respectively, and set aside;

[0053] (2) Preparation of dry granules: mix hydroxypropyl methylcellulose and polyoxyethylene WSR N10 evenly, dissolve with an appropriate amount of ethanol with a concentration of 70%, and prepare a carrier material ethanol solution with a mass fraction of 25%; then crystallize Form Oxiracetam is added to ethanol solution of the carrier material to make soft material, and the soft material is passed through a screen to make wet granules, and dried at a drying temperature of 50°C and a drying time of 30 minutes to obtain dry granules;

[0054] (3) Preparation of Oxiracetam Enteric-coated Sustained-release Granules: Mix polyacrylic acid re...

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Abstract

The invention provides an oxiracetam enteric-coated capsule. Oxiracetam in special crystallization form is used as an active component. A composite carrier containing polyoxyethylene PEO and hydroxypropyl methyl cellulose ( or polyvinylpyrrolidone) in the mass ratio of the polyoxyethylene PEO to the hydroxypropyl methyl cellulose being (1-3) to 1, is carefully selected, and the prepared oxiracetamenteric-coated preparation can reduce the dissolution rate of the active component in the stomach, and also has favorable slow control slow release properties and storage stability. The prepared oxiracetam enteric-coated granules are subjected to long-term stability test under the condition that the temperature is 25 DEG C+ / -2 DEG C, and the relative humidity is 60%+ / -10%, and after long-term experiment for 24 months, sample properties, content and related substances all conform to specification. The oxiracetam enteric-coated capsule is good in stability, and long in quality guarantee period.The preparation method is simple, and suitable for industrial production.

Description

technical field [0001] The invention relates to an oral oxiracetam preparation, in particular to an oxiracetam enteric-coated preparation and a preparation method thereof. Background technique [0002] Oxiracetam (CAS No.: 62613-82-5), also known as Olamide, Oxypyramide, is an anti-hypoxic nootropic drug synthesized in 1974 by Italian Spike Chem Company. The pyrazolidinone structure is a cyclic derivative of γ-aminobutyric acid (GABA). Clinically, it is mainly used 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. Clinically, oxiracetam preparations mainly include injections and capsules. Injections enter the human body directly and quickly without the protection of normal physiological barriers of the human body. Therefore, if the dose is improper or the injection is too fast, or there is a problem with the quality of the drug,...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K31/4015A61K47/38A61K47/32A61K47/10A61P25/28
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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