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L-oxiracetam sustained release capsule with good particle fluidity and preparation method of L-oxiracetam sustained release capsule

A technology for sustained-release capsules and fluidity, which is applied to the field of levooxiracetam sustained-release capsules and the preparation thereof, can solve the problems of poor particle fluidity, large difference in release degree, large difference in filling amount, etc. The process is simple and feasible, the particles have good fluidity, and the effect of reducing the number of doses

Inactive Publication Date: 2018-02-02
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 levo-oxiracetam mainly suffers from poor fluidity of the granules, large differences in the filling and filling process, poor control of the release rate, and failure to meet the requirements of sustained-release preparations. The release rate of different samples in the same batch of products is different. Larger, leading to large differences in product quality, capsules are prone to sticking and caking during storage, and technical problems such as large increments of related substances

Method used

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  • L-oxiracetam sustained release capsule with good particle fluidity and preparation method of L-oxiracetam sustained release capsule
  • L-oxiracetam sustained release capsule with good particle fluidity and preparation method of L-oxiracetam sustained release capsule
  • L-oxiracetam sustained release capsule with good particle fluidity and preparation method of L-oxiracetam sustained release capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A levoxiracetam sustained-release capsule with good granular fluidity 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, calcium hydrogen phosphate, micronized silica gel, sodium thiosulfate Put in the mixing pulverizer and mix and pulverize into fine powder (the amount that can pass through No. 5 sieve and can pass through No. 6 sieve must not be less than 95% of the total amount), and sieve;

[0027] 2. Granulation: add ethanol solution, mix and granulate with 18-mesh sieve, place the prepared wet granules in a hot air oven, set the temperature at 40°C to 60°C, dry until the moisture content of the granules is ≤3%, and granulate (over 24 mesh sieves), standby;

[0028] 3. Total blending: crush stearyl alcohol and magnesium stearate through...

Embodiment 2

[0067] A levoxiracetam sustained-release capsule with good granular fluidity is prepared according to the following steps:

[0068]

[0069] Preparation process: prepared according to the preparation process of Example 1. Carry out the test by the test method of embodiment 1, and the test result of release degree shows that levoxiracetam is released slowly, and the release time is as long as 12 hours, and the release degree RSD of each sample at different time points is all less than 6%, and the angle of repose is measured three times All are less than 35°, indicating that the particles have good fluidity. The results of the stability test show that the quality of the sample is stable in six months of acceleration. There is no capsule adhesion during storage, and the increase of impurities is only 0.05%. Capsule adhesion phenomenon, impurity increment is only 0.06%, so this product is valid for at least 24 months.

Embodiment 3

[0071] A levoxiracetam sustained-release capsule with good granular fluidity is prepared according to the following steps:

[0072]

[0073] Preparation process: prepared according to the preparation process of Example 1. Carry out the test by the test method of embodiment 1, the test result of release degree shows that levoxiracetam is slow release, and the release time is up to 12 hours, and the release rate RSD of each sample at different time points is all less than 5%, and the angle of repose is measured three times All are less than 34°, indicating that the particles have good fluidity. The results of the stability test show that the quality of the sample is stable in six months of acceleration. There is no capsule adhesion during storage, and the increase of impurities is only 0.05%. The quality is stable for 24 months in a long period of time. Capsule adhesion phenomenon, the increase of impurities is only 0.05%, so the validity period of this product is at least 24...

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Abstract

The invention provides an L-oxiracetam sustained release capsule with good particle fluidity. The L-oxiracetam sustained release capsule with good particle fluidity is prepared from the following rawand auxiliary materials in parts by weight: 1 part of L-oxiracetam, 1.2-1.9 parts of lactose, 0.9-1.6 parts of hydroxypropyl methyl cellulose K4M, 1.3-1.8 parts of hydroxypropyl methyl cellulose K15M,0.5-1.1 parts of carnauba wax, 0.15-0.23 part of stearyl alcohol, 0.17-0.26 part of magnesium stearate, 0.23-0.38 part of calcium hydrophosphate, 0.38-0.51 part of superfine silica powder, 0.16-0.27part of sodium thiosulfate, and 3.2-3.9 parts of alcohol solution with the volume fraction being 50-60 %. The L-oxiracetam sustained release capsule provided by the invention has the advantages that the release uniformity is good, the RSDs of release rates at all time points among different samples are smaller than 6%, the releasing speed is low, the releasing period is as long as 12h, the particle fluidity is good, and the angle of repose is smaller than 35 degrees; meanwhile, the product is good in stability, the capsule adhesion phenomenon does not occur during the storage process, the content of related substance is only increased by 0.05%, and the shelf life can reach 24 months.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam sustained-release capsule with good particle fluidity and a preparation method thereof. Background technique [0002] Nootropic drug, also known as brain activator, is a new type of central nervous system drug that promotes learning and enhances memory. Nootropic drugs are required to selectively act on the cerebral cortex, and have the characteristics of selectively activating, protecting and promoting the recovery of damaged nerve cell functions. The difference from other neurological drugs is that their above-mentioned effects do not pass through the reticular system or the olfactory bulb, but directly act on the cortex. It neither affects behavior nor has sedative and exciting effects, so this class of drugs has attracted widespread attention and interest, and the demand for this class of drugs is also increasing day by day. [0003] Oxiracetam (oxir...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K47/38A61K47/26A61K47/44A61K47/10A61K47/12A61K47/02A61K47/04A61K31/4015A61P25/28A61P25/00
CPCA61K9/0002A61K9/1611A61K9/1617A61K9/1623A61K9/1652A61K9/1664A61K9/1682A61K31/4015
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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