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Film-coated tablet containing azithromycin, and preparation method of film-coated tablet

A technology for azithromycin and film coating, applied in the field of film-coated tablets containing azithromycin compounds and its preparation, can solve the problems of high clinical application cost and limited application development of azithromycin, and improve the clinical application of expensive, easy to master and adjust, cost reduction effect

Inactive Publication Date: 2012-07-25
HARBIN PHARMA GRP CO LTD GENERAL PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, at present, azithromycin has the problem of high clinical application cost, which limits its application development.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] (1) Azithromycin is pulverized and passed through an 80-mesh sieve for subsequent use, and the auxiliary material is passed through an 80-mesh sieve for subsequent use;

[0024] (2) By weight, mix 70 parts of azithromycin, 8 parts of sodium starch glycolate, 7 parts of hydroxypropyl cellulose, 3 parts of talcum powder and 4 parts of microcrystalline cellulose, add 5 parts of starch Make a soft material with uniform dryness and wetness, granulate through a 20-mesh sieve, and dry at a constant temperature of 40°C;

[0025] (3) 1.5 parts of magnesium stearate are added in the above-mentioned dry granules and mixed uniformly to obtain mixed granules;

[0026] (4) The above-mentioned mixed granules are compressed into tablets, and the weight of the tablets is controlled; the azithromycin tablets are coated with 3 parts of film-coating powder to obtain the azithromycin film-coated tablets.

Embodiment 2

[0028] (1) Azithromycin is pulverized and passed through an 80-mesh sieve for subsequent use, and the auxiliary material is passed through an 80-mesh sieve for subsequent use;

[0029] (2) By weight, mix 75 parts of azithromycin, 12 parts of sodium starch glycolate, 4 parts of hydroxypropyl cellulose, 4 parts of talcum powder and 5 parts of microcrystalline cellulose, add 8 parts of starch Make a soft material with uniform dryness and wetness, granulate through a 20-mesh sieve, and dry at a constant temperature of 70°C;

[0030] (3) 1 part of magnesium stearate is added in the above-mentioned dry granules and mixed uniformly to obtain mixed granules;

[0031] (4) The above-mentioned mixed granules are compressed into tablets, and the weight of the tablets is controlled; the azithromycin tablets are coated with 4 parts of film-coating powder to obtain the azithromycin film-coated tablets.

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PUM

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Abstract

The invention relates to a film-coated tablet containing azithromycin, and a preparation method of the film-coated tablet. The tablet comprises (by weight parts) azithromycin 60-80, sodium carboxymethyl starch 5-15, hydroxypropyl cellulose 2-10, talcum powder 1-10, microcrystalline cellulose 2-20, magnesium stearate 0.5-2.5, starch 2-30, and film coating powder 1-6. The preparation method comprises sieving, mixing, granulating, tabletting, and coating. The film-coated tablet provided by the invention has the advantages of easily controlled labeled amount, no obvious increase of related substances, fast dissolution, stable tablet weight difference, good production controllability, high quality, masked odor after coating, good stability, high mass production yield, and low cost, and the preparation method has the advantages of simple preparation method, easy grasp and regulation, stable and controllable product quality.

Description

technical field [0001] The invention belongs to the field of azithromycin tablets and preparation thereof, in particular to a film-coated tablet containing azithromycin compound and a preparation method thereof. Background technique [0002] Azithromycin (azithromycin) is a broad-spectrum antibiotic derived from erythromycin A, the chemical name is 9-deoxy-10α-aza-10α-carbo-erythromycin, and it is the first one developed by Priva Pharmaceuticals in Croatia. 15-membered ring macrolide derivative. Azithromycin has a wider antibacterial spectrum than erythromycin, has strong antibacterial activity against Gram-positive bacteria, and has strong antibacterial activity against some Gram-negative bacteria, anaerobic bacteria and Chlamydia trachomatis. Azithromycin inhibits the synthesis of ribosomal 50s subunit protein in bacterial cells and hinders the process of bacterial transpeptide, thereby inhibiting the synthesis of bacterial proteins and achieving antibacterial effects. S...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/28A61K31/7052A61K47/38A61P31/04
Inventor 王喜军石晓莹白铁忠
Owner HARBIN PHARMA GRP CO LTD GENERAL PHARMA FACTORY
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