S-oxiracetam sustained release capsule with high particle flowability and preparation method thereof

A sustained-release capsule and fluidity technology, which is applied in the field of levoxiracetam sustained-release capsules and its preparation, can solve the problems of poor particle fluidity, large difference in release degree, and large difference in loading capacity, and achieve the goal of preparing The process is simple and feasible, the number of times of taking is reduced, and the effect of uniform release is good

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, technical problems such as easy adhesion and caking of capsules during storage

Method used

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  • S-oxiracetam sustained release capsule with high particle flowability and preparation method thereof
  • S-oxiracetam sustained release capsule with high particle flowability and preparation method thereof
  • S-oxiracetam sustained release capsule with high particle flowability and preparation method thereof

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, and micropowdered silica gel and put them in a mixing grinder 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 mixing: crush the calcium hydrogen phosphate and micropowder silica gel thr...

Embodiment 2

[0066] A levoxiracetam sustained-release capsule with good granular fluidity is prepared according to the following steps:

[0067]

[0068] 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 36°, 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, and no capsule adhesion is observed during storage. The quality is stable for 24 months, and no capsule adhesion is observed during storage. At least 24 months.

Embodiment 3

[0070] A levoxiracetam sustained-release capsule with good granular fluidity is prepared according to the following steps:

[0071]

[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 38°, indicating that the particles have good fluidity. The stability test results show that the quality of the sample is stable in six months after acceleration, and no capsule adhesion is observed during storage. The quality is stable for 24 months, and no capsule adhesion is observed during storage. At least 24 months.

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Abstract

The invention provides an S-oxiracetam sustained release capsule with high particle flowability. The S-oxiracetam sustained release capsule is prepared from the following raw and auxiliary materials including 1 part of S-oxiracetam, 1.5 to 2.1 parts of lactose, 1.2 to 1.8 parts of hydroxypropyl methyl cellulose K4M, 0.6 to 1.1 parts of hydroxypropyl methyl cellulose K15M, 0.8 to 1.3 parts of carnauba wax, 0.08 to 0.16 part of octadecanol, 0.13 to 0.18 part of magnesium stearate, 0.2 to 0.9 part of calcium hydrophosphate, 0.5 to 1.1 parts of superfine silica powder and 2.8 to 3.6 parts of 50-60% of ethanol solution. The S-oxiracetam sustained release capsule provided by the invention has the advantages that the release uniformity is high; the release degree RSD of different samples in eachtime point is smaller than 6 percent; the release period is as long as 12 hours; the particle flowability is high; the rest angle is smaller than 38 degrees; meanwhile, the product stability is high;a capsule adhesion phenomenon is not discovered in the storage process; and the shelf life is as long as 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): A61K9/52A61K31/4015A61K47/38A61K47/26A61K47/32A61K47/34A61K47/36A61P25/28
CPCA61K9/0002A61K9/1623A61K9/1635A61K9/1641A61K9/1652A61K31/4015
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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