Sustained-release levorotatory oxiracetam capsules and preparation method thereof

A capsule and slow technology, applied in the field of levooxiracetam capsules and preparation thereof, can solve the problems of inability to achieve sustained-release preparations, multiple layers of granules and powders, large differences in release degree, etc., and achieve simple and feasible preparation process and uniform release. Good sex, slow release effect

Inactive Publication Date: 2018-02-06
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 capsules 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 product quality differences. After granulation, the granule powder layer Many, low yield of finished product, easy to stick and agglomerate capsules during storage, large increment of related substances and other technical problems

Method used

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  • Sustained-release levorotatory oxiracetam capsules and preparation method thereof
  • Sustained-release levorotatory oxiracetam capsules and preparation method thereof
  • Sustained-release levorotatory oxiracetam capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] A slow-release levoxiracetam capsule prepared by 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. Add povidone K30 ethanol solution, mix and granulate with an 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 sieves), standby;

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

Embodiment 2

[0066] A slow-release levoxiracetam capsule prepared by 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, 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 yield measurement result It shows that the yield of this product is as high as 93.8%, and the yield of this product is good. The stability test results show that the sample quality is stable in June, and the impurity increase is only 0.06%. The quality is stable for 24 months, and the impurity increase is only 0.05%. , There is no capsule adhesion and agglomeration during storage, so the validity period of this product is at least 24 months.

Embodiment 3

[0070] A slow-release levoxiracetam capsule prepared by the following steps:

[0071]

[0072] 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 6%, and the yield measurement result It shows that the yield of this product is as high as 94.5%, and the yield of this product is good. The stability test results show that the sample quality is stable in June, and the impurity increment is only 0.05%. The long-term 24-month quality is stable, and the impurity increment is only 0.05%. , There is no capsule adhesion and agglomeration during storage, so the validity period of this product is at least 24 months.

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Abstract

The invention relates to sustained-release levorotatory oxiracetam capsules, which are prepared from the following raw materials and auxiliary materials: 1 part of levorotatory oxiracetam, 1.1-1.9 parts of lactose, 1.5-2.2 parts of hydroxypropyl methyl cellulose K4M, 0.9-1.5 parts of hydroxypropyl methyl cellulose K15M, 0.5-1.1 parts of carnauba wax, 0.18-0.31 part of stearyl alcohol, 0.2-0.9 partof calcium hydrogen phosphate, 0.3-1.0 part of micropowder silica gel, 0.21-0.28 part of sodium thiosulfate and 3.1-3.8 parts of 5 to 10% povidone K30 ethanol solution. The sustained-release levorotatory oxiracetam capsules are fewer in powder layers after granulation, has a product yield reaching up to 91.6%, and is good in release uniformity; the release rates RSD of different samples are lessthan 6% at different time points; the sustained-release levorotatory oxiracetam capsules are slow in release speed and have a release cycle of up to 12h; furthermore, the product provided by the invention is good in stability, does not have a capsule adhesion phenomenon in a storage process, has impurity increment of only 0.05%, and has the shelf life of up to 24 months.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a slowly releasing levoxiracetam capsule and a preparation method thereof. Background technique [0002] Oxiracetam was launched in Italy in 1987 in the form of tablet, 800mg; capsule, 800mg; injection, 1g / 5ml. At present, only oxiracetam capsules and injections are on the market in China, and the main active ingredients used are racemates. Ye Lei et al mentioned in the patent publication No. CN 103735545 A that levoxiracetam has an obvious wake-promoting effect on coma caused by alcoholism, while dextro-oxiracetam has basically no effect. The wake-up effect is twice that of racemic oxiracetam; levo-oxiracetam has significant awakening effects on trauma and coma induced by anesthesia. Zhang Feng et al disclosed in the patent with the publication number CN103599101 A that levoxiracetam can significantly improve the learning, memory and cognitive dysfunction of rats with ...

Claims

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Application Information

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