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Levo-oxiracetam slow-release tablet and preparation method thereof

A technology of slow-release tablets and slow-release matrix materials, which is applied in the direction of pharmaceutical formulas, medical preparations with no active ingredients, and medical preparations containing active ingredients, etc. Patient health and other issues, to achieve the effect of reducing adverse drug reactions, reducing the number of times of taking, and improving safety

Active Publication Date: 2014-02-26
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because oxiracetam injection can only be used in the presence of medical personnel, it is extremely inconvenient for patients to use and greatly reduces the convenience of drug use
Although oxiracetam capsules can be administered orally by themselves, they need to be taken 3 times a day, which is cumbersome to take, and there may be situations such as forgetting to take and missing doses due to too many times of taking the medicine, which seriously endangers the health of patients

Method used

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  • Levo-oxiracetam slow-release tablet and preparation method thereof
  • Levo-oxiracetam slow-release tablet and preparation method thereof
  • Levo-oxiracetam slow-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A levoxiracetam slow-release tablet, prepared according to the following steps:

[0026] Chip composition

[0027] Element

Dosage

[0028] Levoxiracetam

1 copy

Hypromellose (K 4 M)

0.65 servings

Chitin

0.15

Micropowder silica gel

0.06 parts

Magnesium stearate

0.02 parts

Talc powder

0.02 parts

65% ethanol

1.1 copies

[0029] Made into 1000 pieces

[0030] Coating composition:

[0031]

[0032] Preparation process:

[0033] (1) Mix and pulverize levoxiracetam and the slow-release framework material into fine powder (the amount that passes through the No. 5 sieve and the No. 6 sieve that can pass through shall not be less than 95% of the total amount), and sieve;

[0034] (2) Add binder, mix and granulate (pass through 18 mesh sieve), place the prepared wet granules in a hot air oven, set the temperature at 40-60...

Embodiment 2

[0053] A levoxiracetam slow-release tablet, prepared according to the following steps:

[0054] Chip composition

[0055] Element

Dosage

Levoxiracetam

1 copy

Hypromellose (K 4 M)

0.90 servings

Chitin

0.30 servings

[0056] Micropowder silica gel

0.12 parts

Magnesium stearate

0.05 parts

Talc powder

0.05 parts

65% ethanol

1.5 servings

[0057] Made into 1000 pieces

[0058] Coating composition:

[0059]

[0060] Preparation process: prepared according to the preparation process of Example 1.

[0061] (1) Determination of release rate

[0062] Measure according to embodiment 1 release degree measuring method, the measurement result of its release degree is shown in Table 2, figure 2 (done six samples to measure).

[0063] Table 2 Sustained-release tablet sample release rate (%) of the present invention

[0064]

[0065...

Embodiment 3

[0069] A levoxiracetam slow-release tablet, prepared according to the following steps:

[0070] Chip composition

[0071] Element

Dosage

Levoxiracetam

1 copy

Hypromellose (K 4 M)

0.85 parts

Chitin

0.15 parts

Micropowder silica gel

0.12 parts

Magnesium stearate

0.03 copies

Talc powder

0.05 parts

65% ethanol

1.3 parts

[0072] Made into 1000 pieces

[0073] Coating composition:

[0074]

[0075] Preparation process: prepared according to the preparation process of Example 1.

[0076] (1) Determination of release rate

[0077] Measure according to embodiment 1 release degree measuring method, the measurement result of its release degree is shown in Table 3, image 3 (done six samples to measure).

[0078] (1) The assay results of the release of the sustained-release tablet sample of the present invention are shown in Table 3, ...

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Abstract

The invention relates to a levo-oxiracetam slow-release tablet mainly prepared from levo-oxiracetam, which is prepared from the following raw and auxiliary materials in parts by weight: 0.8-1.2 parts of slow-release framework material, 0.06-0.12 part of flow aid, 0.02-0.05 part of lubricant, 0.02-0.05 part of antisticking agent and 1-1.5 parts of adhesive. The levo-oxiracetam slow-release tablet is used for treating brain injury, and neural afunction and disturbance of memory and intelligence caused by brain injury, and has a smooth surface; the detection proves that the release behavior of the main drug levo-oxiracetam satisfies the requirements for the slow-release tablet; and the main drug levo-oxiracetam is slowly released, so the levo-oxiracetam slow-release tablet can be taken less frequently than the traditional preparation. The main drug levo-oxiracetam in the levo-oxiracetam slow-release tablet is slowly released, and can provide steady and enduring effective blood concentration, thereby avoiding or reducing the phenomena of peaks and troughs of blood concentration, and being beneficial to enhancing the medicine application safety and reducing the untoward reaction of the medicine.

Description

technical field [0001] The invention mainly relates to the field of pharmaceutical technology, in particular to a sustained-release tablet whose main component is levoxiracetam and a preparation method thereof. Background technique [0002] Oxiracetam (oxiracetam, CAS No.: 62613—82-5) chemical name is 4-hydroxy-2-oxo-1-pyrrolidineacetamide, which was first synthesized by ISFS.P.A in Italy in 1974. Oxygen nootropic drug (compound disclosed in US4118396), is a derivative of cyclic GABOB, which can promote the synthesis of phosphorylcholine and phosphorylethanolamine, promote brain metabolism, pass through the blood-brain barrier, and have a stimulating effect on specific central nervous system. It can improve intelligence and memory, and also has good curative effect on cerebrovascular disease, traumatic brain injury, brain tumor, intracranial infection, brain degenerative disease, etc., and the drug has extremely low toxicity, no mutagenic, carcinogenic and reproductive toxic...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K9/36A61K31/4015A61K47/38A61K47/36A61P25/00A61P25/28A61P9/10A61P35/00A61P31/00
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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