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A kind of piracetam tablet and preparation method thereof

A technology for piracetam tablets and prescriptions, applied in the field of piracetam tablets and its preparation, can solve the problems of low bioavailability, low dissolution rate, long disintegration time limit, etc., and achieve good fluidity and compressibility , Improve stability, suitable and reasonable effect of prescription

Active Publication Date: 2022-07-12
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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  • A kind of piracetam tablet and preparation method thereof
  • A kind of piracetam tablet and preparation method thereof
  • A kind of piracetam tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Example 1 Preparation of Piracetam Tablets

[0065] Prescription ingredients and dosage:

[0066] Element Preparation of 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 First-layer gastrosoluble film coating premix (white) 2.688kg 6.4 The second layer of gastrosoluble film coating premix (transparent color) 0.268 0.32 purified water 41.14kg 97.945

[0067] Preparation:

[0068] (1) Pretreatment: weigh the raw material of piracetam and add it to the universal pulverizer for pulverization. Sodium methylcellulose was passed through an 80-mesh sieve, for use;

[0069] (2) Premixing / granulation: Weigh the pretreated piracetam, croscarmellose sodium, internally added colloidal silicon dioxide (40% of the recipe amount), internally added polyethylene glycol 6000 (40%...

Embodiment 2

[0085] Example 2 Preparation of Piracetam Tablets

[0086] Prescription ingredients and dosage:

[0087] Element Preparation of 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 First-layer gastrosoluble film coating premix (white) 5.38 12.8 The second layer of gastrosoluble film coating premix (transparent color) 0.269 0.64 purified water 195kg 464.2

[0088] Preparation:

[0089] (1) Pretreatment: weigh the raw material of piracetam and add it to the universal pulverizer for pulverization. Sodium methylcellulose was passed through an 80-mesh sieve, for use;

[0090] (2) Premixing / granulation: Weigh the pretreated piracetam, croscarmellose sodium, add colloidal silicon dioxide (50% of the recipe), add polyethylene glycol 6000 (50% of the recipe quantity) was added into ...

Embodiment 3

[0106] Example 3 Preparation of Piracetam Tablets

[0107] Prescription ingredients and dosage:

[0108] Element Preparation of 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 First-layer gastrosoluble film coating premix (white) 8.06kg 19.2 The second layer of gastrosoluble film coating premix (transparent color) 0.40kg 0.96 purified water 123.4kg 293.835

[0109] Preparation:

[0110] (1) Pretreatment: weigh the raw material of piracetam and add it to the universal pulverizer for pulverization or sieving. The sieve aperture is 100 meshes, and D90 is required not to exceed 390 microns; polyethylene glycol 6000, colloidal silica, Cross-linked sodium carboxymethyl cellulose was passed through 80 mesh sieves for use;

[0111] (2) Premixing / granulation: Weigh the pretr...

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Abstract

The invention discloses a piracetam tablet and a preparation method thereof, comprising 200-800 parts by weight of piracetam, 4.175-18.37 parts by weight of croscarmellose sodium, and 6,000 5-30 parts by weight of polyethylene glycol , 3.675-16.17 parts by weight of colloidal silicon dioxide, 0.75-4 parts by weight of magnesium stearate, 6.72-29.57 parts by weight of stomach-dissolving film coating premix, 97.945-391.78 parts by weight of purified water; the method comprises: (1 ) pretreatment: crush or sieve various raw and auxiliary materials; (2) premix granulation: pretreated piracetam, croscarmellose sodium, added polyethylene glycol 6000 and added The colloidal silica is added to the mixing granulator, stirred and mixed, purified water is added, and granulated by stirring; (3) Drying and granulation: after drying the obtained granules, add additional polyethylene glycol 6000 and Additional colloidal silicon dioxide, magnesium stearate, mixed and granulated; (4) total mixing, tableting, and two-layer coating. The piracetam tablet of the invention covers up the bitterness, has good dissolution, and has a short disintegration time limit, and improves 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 novel thinking-promoting memory drug. It has a protective effect on cerebral hypoxic injury and promotes the recovery of the damaged brain. Piracetam has strong selectivity, no analgesic, sedative or psychoactive effects, no adverse reactions to psychotropic drugs, and no dependence. [0003] At present, piracetam tablets are mainly used for the memory and thinking function impairment caused by various reasons such as cerebral arteriosclerosis, cerebrovascular accident, etc., and can also be used for senile mental decline syndrome, senile dementia, and children with mental retardation. Wait. Piracetam tablets were first listed in my country by Jiangsu Wuzhong Industrial Co., Ltd. Suzhou Pharmaceutical Factory in...

Claims

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Application Information

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Patent Type & Authority Patents(China)
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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