A kind of levoxiracetam sustained-release capsule with good stability and preparation method thereof

A technology for sustained-release capsules and stability, which is applied in the field of levoxiracetam sustained-release capsules and its preparation, and can solve problems such as failure to meet the requirements of sustained-release preparations, poor control of release, and large differences in product quality. , to achieve the effect of simple and feasible preparation process, slow release speed and reduced taking times

Active Publication Date: 2018-10-26
CHONGQING RUNZE PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The existing oxiracetam oral preparations mainly have the release rate that cannot be well controlled and cannot meet the requirements of sustained-release preparations. The release rate of different samples in the same batch of products varies greatly, resulting in large differences in product quality and the increase of related substances in the storage process. Technical problems such as large quantities

Method used

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  • A kind of levoxiracetam sustained-release capsule with good stability and preparation method thereof
  • A kind of levoxiracetam sustained-release capsule with good stability and preparation method thereof
  • A kind of levoxiracetam sustained-release capsule with good stability and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A kind of levoxiracetam sustained-release capsule with good stability is prepared according to the following steps:

[0024]

[0025] Preparation process:

[0026] 1. Pretreatment of raw and auxiliary materials: take the prescribed amount of levoxiracetam, lactose, hydroxypropylmethylcellulose K4M, hydroxypropylmethylcellulose K15M, carnauba wax, and sodium thiosulfate, mix and pulverize in a mixing grinder Become fine powder (all pass through No. 5 sieve and the amount that can pass through No. 6 sieve must not be less than 95% of total amount), sieve;

[0027] 2. Granulation: Add ethanol solution, mix and granulate with 18-mesh sieve, place the 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 (over 24 Mesh sieve), spare;

[0028] 3. Total blending: crush stearyl alcohol through a 100-mesh sieve, add it to the granulated granules, and mix with a three-dimensional motion mixer for 1...

Embodiment 2

[0060] A kind of levoxiracetam sustained-release capsule with good stability is prepared according to the following steps:

[0061] Preparation process: prepared according to the preparation process of Example 1. Carry out the test by the test method of embodiment 1, and release degree test result shows that levoxiracetam is slow release, and release time is up to 12 hours, and the release degree RSD of each sample at different time points is all less than 6%, and stability test result It shows that the sample quality is stable in June, and the impurity increase is only 0.05%, and the quality is stable for 24 months, and the impurity increase is only 0.05%, so the validity period of this product is at least 24 months.

Embodiment 3

[0063] A kind of levoxiracetam sustained-release capsule with good stability is prepared according to the following steps:

[0064] Preparation process: prepared according to the preparation process of Example 1. Carry out the test by the test method of embodiment 1, the release measurement test result shows that levoxiracetam is slow release, and the release time is up to 12 hours, and the release RSD of each sample at different time points is all less than 5%, and the stability test result It shows that the sample quality is stable in June, and the impurity increase is only 0.06%, and the quality is stable for 24 months, and the impurity increase is only 0.05%, so the validity period of this product is at least 24 months.

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Abstract

The invention provides levooxiracetam sustained-release capsules with good stability. The levooxiracetam sustained-release capsules are prepared from the following raw and auxiliary materials: 1 part of levooxiracetam, 1.1-1.7 parts of lactose, 1.5-2.2 parts of hydroxypropyl methylcellulose K4M, 0.7-1.5 parts of hydroxypropyl methylcellulose K15M, 0.6-1.1 parts of carnauba wax, 0.12-0.20 part of octadecanol, 0.02-0.08 part of sodium thiosulfate and 2.8-3.5 parts of an ethanol solution with the volume percent of 50%-70%; the levooxiracetam sustained-release capsule provided by the invention has good release uniformity; the release rate RSD of each time point of different samples is less than 6%; the release speed is slow and the release period reaches 12h; meanwhile, the product has good stability and related substances are only increased by 0.05% within a shelf life and the shelf life reaches 24h; and a preparation process is simple and feasible and is worthy of being popularized in the market.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam sustained-release capsule 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 disclos...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/52A61K31/4015A61K47/38A61K47/26A61K47/44A61K47/10A61K47/02A61P25/28A61P25/00
CPCA61K9/0002A61K9/1611A61K9/1617A61K9/1623A61K9/1652A61K9/1664A61K9/1682A61K31/4015
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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