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Levo-oxiracetam particle with good stability and preparation method thereof

A stable and granular technology, applied in the field of levooxiracetam granules and its preparation, can solve the problems of easy-to-adhere screens, easy-to-adhesion blocks, short shelf life, etc., and achieves a simple and feasible preparation process, and is not easy to absorb moisture. Block, good stability

Inactive Publication Date: 2017-12-26
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Existing levo-oxiracetam granules mainly have a large increase in impurities during the preparation process, easy adhesion to the screen during the granulation process, difficulty in granulation, poor stability during storage, strong hygroscopicity of the granules, easy adhesion and caking, and short shelf life , the taste of the particles is poor, and it is not easy to be accepted by patients and other technical problems

Method used

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  • Levo-oxiracetam particle with good stability and preparation method thereof
  • Levo-oxiracetam particle with good stability and preparation method thereof
  • Levo-oxiracetam particle with good stability and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] A stable levo-oxiracetam granule is prepared according to the following steps:

[0028]

[0029] Preparation process:

[0030] 1. Preparation of adhesive: Take the prescribed amount of honey, put it in an iron pot, add purified water with 2 times the weight of honey, stir evenly, heat to 100-105°C, keep warm for 20-25 minutes, take it out, and use 80 Filter through a mesh sieve, take the filtrate, let it cool, add the ethanol of the prescription amount, stir and dissolve, and get final product;

[0031]2. Pretreatment of raw and auxiliary materials: take the prescribed amount of levoxiracetam, L-cysteine, mannitol, microcrystalline cellulose, sodium carboxymethyl cellulose, lactose, sucrose, and ethyl maltol in the universal In the pulverizer, pulverize through a 100-mesh sieve and set aside;

[0032] 3. Granulation: Take the mixed powder obtained after the pretreatment, put it in a wet granulator, add the honey ethanol solution that has been processed before, star...

Embodiment 2

[0075] A stable levo-oxiracetam granule is prepared according to the following steps:

[0076]

[0077] Preparation process: prepared according to the preparation process of Example 1. Observing the granulation process of the product did not find the phenomenon of sticking to the screen, and the product was easy to granulate. Carry out the test by the test method of embodiment 1, product prescription is to the impact test result of the impurity increase of preparation process shows that this product preparation process impurity increase is less, and related substance only increases 0.02% in the preparation process; It tastes good and is easily accepted by the majority of patients; the results of the stability test show that the quality of the sample is stable in 6 months of acceleration and 24 months in the long-term, so the validity period of this product is at least 24 months.

Embodiment 3

[0079] A stable levo-oxiracetam granule is prepared according to the following steps:

[0080]

[0081] Preparation process: prepared according to the preparation process of Example 1. Observing the granulation process of the product did not find the phenomenon of sticking to the screen, and the product was easy to granulate. Carry out the test by the test method of embodiment 1, product prescription is to the impact test result of the impurity increase of preparation process shows that this product preparation process impurity increase is less, and related substance only increases 0.02% in the preparation process; It tastes good and is easily accepted by the majority of patients; the results of the stability test show that the quality of the sample is stable in 6 months of acceleration and 24 months in the long-term, so the validity period of this product is at least 24 months.

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Abstract

The invention relates to a levo-oxiracetam particle with good stability. The particle is prepared from the following raw and auxiliary materials: 1 part of levo-oxiracetam, 0.5-1.1 parts of L-cysteine, 1.2-1.6 parts of mannitol, 1.1-1.8 parts of microcrystalline cellulose, 0.9-1.5 parts of sodium carboxymethyl cellulose, 0.7-1.3 parts of lactose, 0.12-0.18 part of magnesium stearate, 0.9-1.4 parts of polyethylene glycol 4000, 0.6-1.3 parts of hydroxypropyl methylcellulose, 0.3-0.8 part of honey, 11-15 parts of an ethanol solution with a volume fraction of 50%-70%, 1-5 parts of sucrose and 0.02-0.08 part of ethyl maltol. The levo-oxiracetam particle prepared according to the invention has the advantages of small impurity increase of only 0.04%, no adhesion to a screen mesh during granulation, easy granulation, good storage process stability, difficult moisture absorption and caking, a shelf life up to 24 months and good taste, and can be accepted by most patients.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam granule with good stability and a preparation method thereof. Background technique [0002] Oxiracetam (S-oxiracetam) is a synthetic cyclic derivative of hydroxyaminobutyric acid (BABOB), which is only used in the central nervous system, mainly distributed in the cerebral cortex and hippocampus, and has the function of activating, protecting or promoting nerve cells. Functional recovery can improve the memory and learning functions of patients with mental retardation, and the drug itself has no direct vasoactive or central excitatory effect, and its effect on learning and memory is a lasting promotion effect. [0003] Oxiracetam (oxiracetam, CAS No.: 62613-82-5) chemical name is 4-hydroxy-2-oxo-1-pyrrolidineacetamide, which was synthesized for the first time in 1974 by the Italian company ISFS.P.A. Oxygen nootropic drug (compound disclosed in US4118396), ...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/4015A61K47/18A61K47/26A61K47/38A61K47/12A61K47/10A61K47/46A61K47/22A61P25/28
CPCA61K9/1617A61K9/1623A61K9/1641A61K9/1652A61K9/1664A61K31/4015
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD