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(S)-4-hydroxyl-2-oxo-1-pyrrolidine acetamide sustained release tablet and preparing method thereof

一种缓释片、羟丙甲基的技术，应用在医药配方、非有效成分的医用配制品、含有效成分的医用配制品等方向，能够解决降低药物使用方便性、患者使用不方便、危害患者健康等问题，达到减少药物不良反应、减少服用次数、提高安全性的效果

Active Publication Date: 2015-11-18
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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  • (S)-4-hydroxyl-2-oxo-1-pyrrolidine acetamide sustained release tablet and preparing method thereof
  • (S)-4-hydroxyl-2-oxo-1-pyrrolidine acetamide sustained release tablet and preparing method thereof
  • (S)-4-hydroxyl-2-oxo-1-pyrrolidine acetamide sustained release tablet and preparing 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]

[0028] Coating composition:

[0029]

[0030] Preparation process:

[0031] (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;

[0032] (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°C, dry until the moisture content of the granules is ≤3%, and granulate (pass through 18 mesh sieve), standby;

[0033] (3) Glidant, lubricant, anti-tack agent are pulverized through a 100-mesh sieve, added to the granulated granules, and mixed evenly;

[0034] (4) Tablet coating: adjust the tablet press, press the tablet, and pack the compressed sustained-release tablet with a mois...

Embodiment 2

[0052] A levoxiracetam slow-release tablet, prepared according to the following steps:

[0053] Chip composition

[0054]

[0055] Coating composition:

[0056]

[0057] Preparation process: prepared according to the preparation process of Example 1.

[0058] (1) Determination of release rate

[0059] 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).

[0060] Table 2 Sustained-release tablet sample release rate (%) of the present invention

[0061]

[0062] test results:

[0063] Appearance: Film-coated tablet with smooth surface.

[0064] Release: Levoxiracetam Sustained-release Tablets The main ingredient, Levo-Oxiracetam, is released slowly, which can meet the requirements of sustained-release tablets.

Embodiment 3

[0066] A levoxiracetam slow-release tablet, prepared according to the following steps:

[0067] Chip composition

[0068]

[0069] Coating composition:

[0070]

[0071] Preparation process: prepared according to the preparation process of Example 1.

[0072] (1) Determination of release rate

[0073] 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).

[0074] (1) The assay results of the release of the sustained-release tablet sample of the present invention are shown in Table 3, image 3 (done six samples to measure).

[0075] Table 3 Sustained-release tablet sample release rate (%) of the present invention

[0076]

[0077] test results:

[0078] Appearance: Film-coated tablet with smooth surface.

[0079] Release: Levoxiracetam Sustained-release Tablets The main ingredient, Levo-Oxiracetam, is released slowly, which can meet the require...

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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

[0001] The application of the present invention is for a divisional application with the application number 201310654327.6 and the title of the invention "Levoxiracetam Sustained-release Tablets and Preparation Method thereof". technical field [0002] 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 [0003] Oxiracetam (oxiracetam, CASNo.: 62613-82-5) chemical name is 4-hydroxy-2-oxo-1-pyrrolidineacetamide, which was first synthesized by the Italian ISFS.P.A company in 1974 to resist hypoxia 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 the specific central nervous system. Improve intelligence and memory, ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/4015A61K47/38A61K47/36A61P9/10A61P25/28A61P25/00
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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