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Levo-S-oxiracetam granule with good content uniformity and preparation method thereof

A technology of uniformity and granulation, which is applied in the field of levo-oxiracetam granules and its preparation, can solve the problems of difficult control of particle size, strong hygroscopicity of granules, easy adhesion and agglomeration, etc., and achieve simple and feasible preparation process and uniform granule content Good performance, not easy to absorb moisture and agglomerate

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

[0004] The main problems of existing levoxiracetam granules are that the impurities in the preparation process increase greatly, the particle powder layer is more, the particle size is not easy to control, the main drug is not easy to mix evenly during the mixing process, the content uniformity is poor, the storage process stability is poor, and the granules are hygroscopic. Strong, easy to stick and agglomerate, short shelf life and other technical problems

Method used

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  • Levo-S-oxiracetam granule with good content uniformity and preparation method thereof
  • Levo-S-oxiracetam granule with good content uniformity and preparation method thereof
  • Levo-S-oxiracetam granule with good content uniformity and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] A levoxiracetam granule with good content uniformity is prepared according to the following steps:

[0026]

[0027] Preparation process:

[0028] 1. Pretreatment of raw and auxiliary materials: take the prescribed amount of levoxiracetam and dissolve it in the prescribed amount of ethanol solution to obtain levoxiracetam ethanol solution, and set aside; take L-cysteine, mannitol, and microcrystalline fiber in addition Sodium carboxymethyl cellulose, lactose, and sorbitol are placed in a universal pulverizer, pulverized through a 100-mesh sieve, and set aside;

[0029] 2. Granulation: place the mixed powder of the excipients obtained in the pretreatment and ethanol solution of levoxiracetam in a wet granulator, add starch slurry, start the granulator (install 18-mesh nylon sieve), and start granulation;

[0030] 3. Drying: Put the wet granules into the fluidized bed, set the temperature of the hot bed at 50°C to 70°C, and start drying; observe the boiling and blasting...

Embodiment 2

[0083] A levoxiracetam granule with good content uniformity is prepared according to the following steps:

[0084]

[0085] Preparation process: prepared according to the preparation process of Example 1. Carry out the test by the test method of embodiment 1, the Hughes angle test measurement result shows that this product granule fluidity is good, and Hughes angle is lower than 36 °, and the content uniformity test result shows that this product content uniformity is good, each after its total mixing The content RSD of point granules is less than 1%. The difference test of the filling volume shows that the loading volume of this product is less than ±4%. The loading volume of this product is stable and controllable. The increase is small, and the relevant substances in the preparation process only increase by 0.02%. The stability test results show that the sample quality is stable in six months after acceleration, and stable in 24 months in a long-term period, so the valid...

Embodiment 3

[0087] A levoxiracetam granule with good content uniformity is prepared according to the following steps:

[0088]

[0089] Preparation process: prepared according to the preparation process of Example 1. Carry out the test by the test method of embodiment 1, the Hughes angle test measurement result shows that this product granule fluidity is good, and Hughes angle is lower than 37 °, and the content uniformity test result shows that this product content uniformity is good, each after its total mixing The content RSD of point granules is less than 2%. The difference test of the filling volume shows that the loading volume difference of this product is less than ±5%. The loading volume of this product is stable and controllable. The increase is small, and the related substances only increase by 0.03% in the preparation process. The stability test results show that the quality of the sample is stable in six months after acceleration, and the quality is stable for 24 months in...

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Abstract

The invention relates to a levo-S-oxiracetam granule with good content uniformity. The levo-S-oxiracetam granule is prepared from the following raw and auxiliary materials: 1 part of levo-S-oxiracetam, 0.5-1.1 parts of L-cysteine, 0.7-1.2 parts of mannitol, 0.6-1.2 parts of microcrystalline cellulose, 0.8-1.3 parts of sodium carboxymethyl cellulose, 0.9-1.7 parts of lactose, 0.6-1.3 parts of sorbitol, 0.12-0.17 part of talcum powder, 1.0-1.5 parts of polyethylene glycol 4000, 0.9-1.6 parts of hydroxypropyl methylcellulose, 9-15 parts of starch slurry with a mass fraction of 6%-8%, and 2-7 parts of an ethanol solution with a volume fraction of 30%-50%. The levo-S-oxiracetam granule prepared according to the method provided by the invention has the advantages of small impurity increment of only about 0.04% during preparation, small powder layer amount, uniform particle size, good fluidity, a repose angle of less than 39DEG, a load difference of less than + / -5%, good particle content uniformity, a multipoint content RSD of less than 2%, good storage stability, difficult moisture absorption and caking of product, and a shelf life up to 24 months.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam granule with good content uniformity 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] The drug was launched in Italy in 1987, and the listed dosage forms are tablet, 800mg; capsule, 800mg; injection, 5ml: 1g. At present, only oxiracetam capsules and injections are on the market in China, and the main active ingredien...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4015A61K47/18A61K47/26A61K47/38A61K47/10A61K47/36A61P25/28
CPCA61K9/5031A61K9/5042A61K31/4015A61K47/183A61K47/26A61K47/36A61K47/38
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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