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Orazitan dispersion tablet and its preparation method

A technology of dispersible tablets and molecular weight, which is applied in the field of medicine, can solve the problems of unfavorable drug dissolution and absorption, affect the quality of drugs, etc., and achieve the effects of prolonging the storage period, improving stability, and taking convenience

Inactive Publication Date: 2004-12-22
肖广常 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the currently marketed oral preparations—oxiracetam ordinary tablets and hard capsules disintegrate within 30 minutes, which is not conducive to drug dissolution and absorption
In addition, due to the particularity of the hard capsule shell production process, hard capsules generally suffer from serious aging phenomena. After 1.5 years of storage, the disintegration time limit generally exceeds 40 minutes, or even does not disintegrate, thereby affecting the quality of the drug.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Embodiment 1: oxiracetam dispersible tablet, component is as follows (all are weight ratio):

[0023] Oxiracetam 75.5%

[0024] Starch 7.6%

[0025] Microcrystalline Cellulose 7.6%

[0026] Croscarmellose Sodium 7.6%

[0027] Magnesium Stearate 0.5%

[0028] Silica 0.9%

[0029] Hypromellose 0.3%

[0030] The preparation method is as follows:

[0031] (1) Pass the oxiracetam, starch and microcrystalline cellulose through a 100-mesh sieve respectively, and set aside.

[0032] (2) Weigh 400g of starch and 400g of microcrystalline cellulose according to the prescription, and mix them evenly. Add 4000g of oxiracetam in the prescribed amount, mix well, add binder 1% hypromellose aqueous solution 1500g to make soft material, granulate with 20 mesh sieve, dry at 50-60°C, granulate with 20 mesh sieve, Add 400 g of croscarmellose sodium, 30 g of magnesium stearate, and 50 g of silicon dioxide and mix well.

[0033] (3) Take a sample to test the particle content, calcula...

Embodiment 2

[0037] Embodiment 2: oxiracetam dispersible tablet, component is as follows (all are weight ratio):

[0038] Oxiracetam 36.9%

[0039] Microcrystalline Cellulose 32.3%

[0040] Croscarmellose Sodium 23.0%

[0041] Calcium Stearate 0.9%

[0042] Micronized silica gel 2.3%

[0043] Polyvinylpyrrolidone 4.6%

[0044] The preparation method is as follows:

[0045] (1) Pass the oxiracetam and microcrystalline cellulose through a 100-mesh sieve respectively, and set aside.

[0046] (2) Weigh 1400 g of microcrystalline cellulose according to the prescription, and mix well. Add 1600g of oxiracetam in prescription quantity, mix well, add binder 10% polyvinylpyrrolidone aqueous solution 1000g to make soft material, granulate with 20 mesh sieve, dry at 50-60 ℃, granulate with 20 mesh sieve, add cross 1000 g of sodium carboxymethyl cellulose, 40 g of calcium stearate, and 100 g of micropowder silica gel are mixed evenly.

[0047] (3) Take a sample to test the particle content, cal...

Embodiment 3

[0050] Embodiment 3: oxiracetam dispersible tablet, component is as follows (all are weight ratio):

[0051] Oxiracetam 81.9%

[0052] Starch 6.6%

[0053] Colloidal silicon dioxide 3.2%

[0054] Crospovidone 6.5%

[0055]Magnesium Stearate 0.5%

[0056] Starch slurry 1.3%

[0057] The preparation method is as follows:

[0058] (1) Pass oxiracetam and starch through a 100-mesh sieve respectively, and set aside.

[0059] (2) Weigh 328g of starch according to the prescription, add 4095g of oxiracetam in the prescribed amount, mix well, add 1240g of binder 5% starch slurry to make soft material, granulate with 20 mesh sieve, dry at 50-60°C, Sieve through a 20-mesh sieve, add 327g of crospovidone and 25g of magnesium stearate and mix well.

[0060] (3) Take a sample to test the particle content, calculate the tablet weight according to the measured particle content, and compress the tablet.

[0061] (4) Sampling and full inspection, and packaging to obtain finished product...

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PUM

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Abstract

A dispersing oxiracetam tablet for preventing senile dementia and treating hypomnesia is prepared from oxiracetam, disintegrant,lubricant, flowing aid and adhesive through proportionally and sequentially mixing, granulating, baking and tabletting. Its advantage is high curative effect.

Description

(1) Technical field [0001] The invention relates to oxiracetam dispersible tablets and a preparation method thereof, belonging to the technical field of medicine. (2) Background technology [0002] Nootropics, also known as cereboactive drugs, are a new class of central nervous system drugs that can promote learning and enhance memory. Gluurgea was first defined as a nootropic drug. Nootropic drugs require selective action 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 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 is a...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/4015A61P25/00A61P25/28
Inventor 肖广常张颖
Owner 肖广常
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