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Piracetam tablet and preparation method thereof

A piracetam tablet and the technology of piracetam are applied in the direction of pharmaceutical formulations, medical preparations of non-active ingredients, and devices for making drugs into special physical or ingestion forms, which can solve the problems of low dissolution rate, disintegration, etc. Solve the problems of long time limit and low bioavailability, and achieve the effects of good fluidity and compressibility, suitable and reasonable prescription, and improved stability

Active Publication Date: 2021-06-11
江西亿友药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the existing piracetam tablets have problems such as extremely bitter taste, poor patient adaptability, long disintegration time limit, low dissolution rate, and low bioavailability.

Method used

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  • Piracetam tablet and preparation method thereof
  • Piracetam tablet and preparation method thereof
  • Piracetam tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] The preparation of embodiment 1 piracetam sheet

[0065] Prescription ingredients and dosage:

[0066] Element Prepare 420,000 tablets parts by weight Piracetam 84.0kg 200 Croscarmellose Sodium 1.75kg 4.175 polyethylene glycol 6000 2.1kg 5 colloidal silica 3.86kg 3.675 Magnesium stearate 1.54kg 3 The first layer of gastric soluble film coating premix (white) 2.688kg 6.4 The second layer of gastric soluble film coating premix (transparent color) 0.268 0.32 purified water 41.14kg 97.945

[0067] Preparation:

[0068] (1) Pretreatment: Weigh the piracetam raw material and add it to a universal pulverizer for pulverization. The sieve aperture is 100 mesh, and the D90 is required to be no more than 390 microns; polyethylene glycol 6000, colloidal silicon dioxide, cross-linked Sodium methylcellulose is passed through an 80-mesh sieve for subsequent use;

[0069] (2) Premixing / granulation: Weigh ...

Embodiment 2

[0085] The preparation of embodiment 2 piracetam tablets

[0086] Prescription ingredients and dosage:

[0087] Element Prepare 420,000 tablets parts by weight Piracetam 168kg 400 Croscarmellose Sodium 3.5kg 8.33 polyethylene glycol 6000 4.2kg 10 colloidal silica 3.09kg 7.36 Magnesium stearate 0.63kg 1.5 The first layer of gastric soluble film coating premix (white) 5.38 12.8 The second layer of gastric soluble film coating premix (transparent color) 0.269 0.64 purified water 195kg 464.2

[0088] Preparation:

[0089] (1) Pretreatment: Weigh the piracetam raw material and add it to a universal pulverizer for pulverization. The sieve aperture is 100 mesh, and the D90 is required to be no more than 390 microns; polyethylene glycol 6000, colloidal silicon dioxide, cross-linked Sodium methylcellulose is passed through an 80-mesh sieve for subsequent use;

[0090] (2) Premixing / granulation: Weigh the p...

Embodiment 3

[0106] The preparation of embodiment 3 piracetam tablets

[0107] Prescription ingredients and dosage:

[0108] Element Prepare 420,000 tablets parts by weight Piracetam 252kg 600 Croscarmellose Sodium 5.26kg 12.525 polyethylene glycol 6000 6.30kg 15 colloidal silica 4.63kg 11.025 Magnesium stearate 3.78kg 9 The first layer of gastric soluble film coating premix (white) 8.06kg 19.2 The second layer of gastric soluble film coating premix (transparent color) 0.40kg 0.96 purified water 123.4kg 293.835

[0109] Preparation:

[0110] (1) Pretreatment: Weigh the piracetam raw material and add it to pulverize or sieve in a universal pulverizer. Croscarmellose sodium is passed through an 80-mesh sieve respectively, for subsequent use;

[0111] (2) Premixing / granulation: Weigh the pretreated piracetam, croscarmellose sodium, add colloidal silicon dioxide (55% of the prescription amount), add polyethylene g...

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Abstract

The invention discloses a piracetam tablet and a preparation method thereof. The piracetam tablet is prepared from the following components in parts by weight: 200 to 800 parts of piracetam, 4.175 to 18.37 parts of croscarmellose sodium, 5 to 30 parts of polyethylene glycol 6000, 3.675 to 16.17 parts of colloidal silicon dioxide, 0.75 to 4 parts of magnesium stearate, 6.72 to 29.57 parts of a gastric-soluble film coating premix and 97.945 to 391.78 parts of purified water. The method comprises the following steps: (1) pretreatment: crushing or sieving various raw and auxiliary materials; (2) premixing and granulating: adding the pretreated piracetam, croscarmellose sodium, internally added polyethylene glycol 6000 and internally added colloidal silicon dioxide into a mixing granulator, stirring and mixing, adding purified water, and stirring and granulating; (3) drying and granulating: drying the prepared granules, adding the added polyethylene glycol 6000 and the added colloidal silicon dioxide and magnesium stearate, mixing and granulating; and (4) total mixing, tabletting and two-layer coating. The piracetam tablet disclosed by the invention covers bitterness, is good in dissolution rate and short in disintegration time limit, and improves the stability and patient compliance.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a piracetam tablet and a preparation method thereof. Background technique [0002] Piracetam, a derivative of γ-aminobutyric acid, is a new drug for promoting thinking and memory. It has a protective effect on cerebral hypoxic injury and promotes the recovery of damaged brain. Piracetam has strong selective action, no analgesic, sedative or psychostimulant effects, no adverse reactions of psychotropic drugs, and no dependence. [0003] At present, piracetam tablets are mainly used for memory and thinking function decline caused by various reasons such as cerebral arteriosclerosis and cerebrovascular accidents in China. It can also be used for senile mental decline syndrome, senile dementia, and mental retardation in children. Wait. Piracetam tablets were first listed in my country by Suzhou Pharmaceutical Factory of Jiangsu Wuzhong Industrial Co...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K31/40A61J3/06A61P25/28A61K47/10A61K47/04
CPCA61K31/40A61K9/2009A61K9/282A61K9/2031A61K9/2886A61K9/2893A61P25/28A61J3/06
Inventor 张嵩张对良徐卫国曾爱民
Owner 江西亿友药业有限公司
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