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L-oxiracetam effervescent tablet which tastes good and preparation method of L-oxiracetam effervescent tablet

An effervescent tablet, good taste technology, applied in pharmaceutical formulations, drug delivery, nervous system diseases and other directions, can solve the problems of difficult patient acceptance, slow gas production and slow disintegration of the finished product, and achieves a simple and feasible preparation process and finished product production. The effect of fast gas and fast disintegration

Inactive Publication Date: 2017-06-27
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 levoxiracetam effervescent preparations mainly have technical problems such as easy sticking and punching during tablet compression, slow gas production, slow disintegration, and poor taste in the finished product, which are not easily accepted by the majority of patients.

Method used

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  • L-oxiracetam effervescent tablet which tastes good and preparation method of L-oxiracetam effervescent tablet
  • L-oxiracetam effervescent tablet which tastes good and preparation method of L-oxiracetam effervescent tablet
  • L-oxiracetam effervescent tablet which tastes good and preparation method of L-oxiracetam effervescent tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] A kind of levoxiracetam effervescent tablet with good taste is prepared according to the following steps:

[0025] Preparation process:

[0026] 1. Take the prescribed amount of dextrin and put it in the mill, add the same quality of purified water, grind and mix, add the prescribed amount of peppermint oil and strawberry essence during the operation, continue to mill for 10 to 20 minutes, take it out, and put it in the In the blast drying oven, set the drying temperature at 45°C and dry until the moisture content is lower than 3%. Take it out, put it in a universal pulverizer, add the prescribed amount of levoxiracetam, tartaric acid, and sucralose, mix and pulverize, and pass through a 100-mesh sieve Finally, collect the mixed powder, place the mixed powder in a wet granulator, add a binder, start the granulator (with an 18-mesh nylon sieve installed), granulate, and obtain acid phase granules for subsequent use;

[0027] 2. Take the prescribed amount of sodium bic...

Embodiment 2

[0063] A kind of levoxiracetam effervescent tablet with good taste is prepared according to the following steps:

[0064] Preparation process: prepared according to the preparation process of Example 1. According to the test method of Example 1, the disintegration time limit inspection, stability test and mouthfeel investigation were carried out respectively. The disintegration time limit inspection results showed that the disintegration speed of this product was fast, and the disintegration time was less than 30 seconds. The stability test results showed that the acceleration was 6 months The quality of the sample is stable, and the quality is stable for 24 months in a long-term. Therefore, the validity period of this product is at least 24 months. The taste survey results show that this product has a good taste and is easily accepted by the majority of patients.

Embodiment 3

[0066] A kind of levoxiracetam effervescent tablet with good taste is prepared according to the following steps:

[0067] Preparation process: prepared according to the preparation process of Example 1. According to the test method of Example 1, the disintegration time limit inspection, stability test and mouthfeel investigation were carried out respectively. The disintegration time limit inspection results showed that the disintegration speed of this product was fast, and the disintegration time was less than 30 seconds. The stability test results showed that the acceleration was 6 months The quality of the sample is stable, and the quality is stable for 24 months in a long-term. Therefore, the validity period of this product is at least 24 months. The taste survey results show that this product has a good taste and is easily accepted by the majority of patients.

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Abstract

An L-oxiracetam effervescent tablet which tastes good is characterized by being made from the following raw and auxiliary materials, according to a weight ratio, 1 part of L-oxiracetam, 3-9 parts of tartaric acid, 3-9 parts of sodium bicarbonate, 0.2-0.8 part of sodium chloride, 0.3-1.2 parts of polyethylene glycol 6000, 4-10 parts of dextrin, 0.6-1.5 parts of sucralose, 0.5-0.9 part of peppermint oil, 0.2-0.8 part of strawberry essence and 15-26 parts of an ethanol solution having the volume fraction of 50-70%. The prepared L-oxiracetam effervescent tablet doesn't stick during a tableting process, is fast in gas production and disintegration speed, and has the disintegration time no more than 30 s. The L-oxiracetam effervescent tablet tastes good, can be easily accepted by most patients, and has a shelf life as long as 24 months. The preparation method is simple and feasible and is worth market popularization.

Description

technical field [0001] The invention mainly relates to the technical field of pharmacy, in particular to a levoxiracetam effervescent tablet with good taste 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 (oxiracetam, CAS No.: 6...

Claims

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Application Information

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IPC IPC(8): A61K9/46A61K31/4015A61P25/28A61P25/00
Inventor 叶雷
Owner CHONGQING RUNZE PHARM CO LTD
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