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Pidotimod orally disintegrating tablet and preparation method thereof

A technology of orally disintegrating tablets and pidotimod, which is applied in the field of pidotimod orally disintegrating tablets and its preparation, can solve the problems of complicated taking process and inconvenient taking for children, and achieve convenient taking, transportation and taking , reduce the effect of liver first-pass effect

Inactive Publication Date: 2017-04-26
ZHEJIANG XIANJU PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to solve the current pidotimod granules, oral solutions and dry suspensions, which are inconvenient for children to take, and the granules and oral solutions must be ingested with water, and the technical problem of complicated taking process

Method used

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  • Pidotimod orally disintegrating tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] The preparation process of Pidotimod orally disintegrating tablets (400 / 600mg):

[0023] (1) Pass pidotimod through a 60-mesh sieve;

[0024] (2) Add and mix the sieved raw materials with the prescribed amount of mannitol, microcrystalline cellulose, crospovidone, croscarmellose sodium, and acesulfame potassium;

[0025] (3) Add silicon dioxide and magnesium stearate to the above mixture, mix well and press into tablets with a weight of 600mg and a hardness of 20-40N.

Embodiment 2

[0027] The preparation process of Pidotimod orally disintegrating tablets (200 / 300mg):

[0028] (1) Pass pidotimod through a 60-mesh sieve;

[0029] (2) Add and mix the sieved raw materials with the prescribed amount of mannitol, microcrystalline cellulose, crospovidone, croscarmellose sodium, and acesulfame potassium;

[0030] (3) Add silicon dioxide and magnesium stearate to the above mixture, mix well and press into tablets with a weight of 300mg and a hardness of 20-40N.

Embodiment 3

[0032] Preparation process of pidotimod orally disintegrating tablets (400 / 500mg):

[0033] (1) Pass pidotimod through a 60-mesh sieve;

[0034] (2) Mix the sieved raw materials with the prescribed amount of lactose, microcrystalline cellulose, crospovidone, croscarmellose sodium, acesulfame potassium and aspartame in equal amounts;

[0035] (3) Add silicon dioxide and magnesium stearate to the above mixture, mix well and press into tablets with a weight of 500mg and a hardness of 20-40N.

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Abstract

The invention discloses a pidotimod orally disintegrating tablet which includes, by mass, 50-90% of pidotimod main drug, 5-10% of a disintegrating agent, 5-30% of a filling agent, 1-5% of a corrigent and 0.05-2% of a lubricant. The invention also discloses a preparation method of the pidotimod orally disintegrating tablet. The method includes the steps of: 1) sieving a pidotimod raw material through a 60-mesh sieve; 2) uniformly mixing the sieved raw material with the filling agent, the disintegrating agent and the corrigent in a manner of increment by equal quantity; 3) adding the lubricant to the mixture, uniformly mixing the components, and tabletting the mixture, wherien each tablet is 500-600 mg in weight and is 20-40 N in hardness. The pidotimod orally disintegrating tablet is free of water for taking and can be disintegrated and dissolved in saliva. Through preparation technology, bad smell of medicine can be covered effectively. The tablet can be packaged by common aluminum plastic package and is convenient to use. The tablet improves compliance during long-time use of patients and is especially suitable for the elders and children.

Description

technical field [0001] The invention relates to a pidotimod orally disintegrating tablet and a preparation method thereof. Background technique [0002] Pidotimod is a sitting immune stimulator, which is suitable for patients with low cellular immune function. The indications include: 1. Recurrent respiratory infections, such as tracheitis, bronchitis, etc.; Inflammation, pharyngitis, tonsillitis, etc.; 3. Recurrent urinary system infection; 4. Recurrent gynecological infection. Pidotimod can be used to prevent infectious diseases, shorten the course of the disease, reduce the severity of the disease, reduce the number of recurrent attacks, and can also be used as an adjuvant drug for antibiotic treatment in acute infection. [0003] The main dosage forms of pidotimod currently on the market are granules, oral solutions, dry suspensions, etc.; both granules and dry suspensions need to be taken after dissolving in boiling water. This product needs to be administered for a lo...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K38/05A61K31/427A61K47/38A61P37/04
CPCA61K9/2054A61K9/0056A61K9/006A61K31/427A61K38/05
Inventor 黄强
Owner ZHEJIANG XIANJU PHARMA
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