Oxiracetam oral preparation and preparation method thereof

Another, oral instant film technology, applied in the field of oxiracetam oral preparations and its preparation, can solve the problems of complex development and production process, coalescence of solid particles, self-administration by patients, etc.

Inactive Publication Date: 2017-06-13
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This type of preparation is directly injected into tissues or blood vessels, and there is no absorption process or the absorption process is very short, so the blood concentration can quickly reach the peak to play a role; Most require higher equipment conditions, and the drugs in the injection are generally dispersed in water as micron-sized solid particles in the molecular state, with a large degree of dispersion, and high-temperature sterilization often results in drug hydrolysis, oxidation, and solid particle coalescence Stability issues such as large size
At the same time, because the injection directly and quickly enters the human body without the protection of the normal physiological barrier of the human body, if the dosage is improper or the injection is too fast, or there is a problem with the quality of the drug, it may bring harm to the patient, or even cause irreparable consequences.
In addition, injection pain, ...

Method used

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  • Oxiracetam oral preparation and preparation method thereof
  • Oxiracetam oral preparation and preparation method thereof
  • Oxiracetam oral preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0089] The preparation of oxiracetam film adopts the following steps:

[0090] 1) Dissolve 58g of film-forming material (acrylic acid ester and hydroxypropyl methylcellulose, wherein the dosage of hydroxypropylmethylcellulose is 30g) with 80mL of deionized water, and remove air bubbles to obtain a uniform viscous liquid;

[0091] 2) Disperse 18g of dibutyl phthalate, 15g of microcrystalline cellulose and 2g of xylitol with 50mL of deionized water to form a dispersion;

[0092] 3) Add the dispersion of step 2) to the viscous liquid of step 1), and add 7g of oxiracetam to disperse evenly, and then let it stand to remove air bubbles;

[0093] 4) Coat the viscous liquid after removing air bubbles with a drug film coating dryer at a coating speed of 50cm / min, then dry at 65-68°C, peel off and cut.

Embodiment 2

[0095] The preparation of oxiracetam film adopts the following steps:

[0096] 1) Dissolve 50g of film-forming material (acrylic acid ester and hydroxypropyl methylcellulose, wherein the dosage of hydroxypropylmethylcellulose is 10g) with 50mL of deionized water, and remove air bubbles to obtain a uniform viscous liquid;

[0097] 2) Disperse 12g triacetin, 20g low-substituted hydroxypropyl cellulose and 1g acesulfame potassium with 60mL deionized water to form a dispersion;

[0098] 3) Add the dispersion of step 2) to the viscous liquid of step 1), and add 17g of oxiracetam to disperse evenly, and then let it stand to remove air bubbles;

[0099] 4) Coat the viscous liquid after removing air bubbles with a drug film coating dryer at a coating speed of 80cm / min, then dry at 70-72°C, peel off and cut.

Embodiment 3

[0101] The preparation of oxiracetam film adopts the following steps:

[0102] 1) Dissolve 50g of film-forming material (acrylic acid ester and hydroxypropyl methylcellulose, wherein the dosage of hydroxypropylmethylcellulose is 20g) with 50mL of deionized water, and remove air bubbles to obtain a uniform viscous liquid;

[0103] 2) Disperse 15g of trimethyl citrate, 15g of microcrystalline cellulose and 5g of aspartame with 40mL of deionized water to form a dispersion;

[0104] 3) Add the dispersion of step 2) to the viscous liquid of step 1), and add 15g of oxiracetam to disperse evenly, then let it stand to remove air bubbles;

[0105] 4) Coat the viscous liquid after removing air bubbles with a drug film coating dryer at a coating speed of 70cm / min, then dry at 80-85°C, peel off and cut.

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Abstract

The invention relates to an oxiracetam oral preparation and a preparation method thereof. The oxiracetam oral preparation is prepared from a composite membrane forming material, a plasticizing agent, a filling agent and the like. The oxiracetam oral preparation has the advantages that the easiness in vomiting is avoided after sticking onto a tongue, and the oxiracetam oral preparation is suitable for old people with difficulty in swallowing; by utilizing mucosae to absorb, the first pass elimination effect is avoided, the bioavailability is improved, the medicine dosage is reduced, and the side effect is decreased. The preparation method has the advantages that the preparation technology is simple, and the preparation method is suitable for industrialized production.

Description

technical field [0001] The invention relates to an oral preparation of oxiracetam and a preparation method thereof. Background technique [0002] Oxiracetam is a synthetic cyclic derivative of hydroxyaminobutyric acid (GABOB), which can promote ATP in the brain, promote the synthesis of acetylcholine and enhance the conduction of nerve excitation, and can improve the retrograde amnesia caused by hypoxia. Can enhance memory and improve learning ability. CN104069074A discloses a freeze-dried preparation of oxiracetam for injection, which is obtained by first forming an aqueous solution of oxiracetam with a certain concentration, and then adding methanol to freeze-dry; Good quality and stable storage. This type of preparation is directly injected into tissues or blood vessels, and there is no absorption process or the absorption process is very short, so the blood concentration can quickly reach the peak to play a role; Most require higher equipment conditions, and the drugs...

Claims

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Application Information

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IPC IPC(8): A61K9/70A61K31/4015A61K47/32A61K47/38A61K47/36A61P25/00
CPCA61K9/006A61K9/7007A61K31/4015A61K47/32A61K47/36A61K47/38
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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