Erythromycin enteric-coated tablets and preparation method thereof

A technology for erythromycin and enteric-coated tablets, applied in the field of antibiotic drugs and their preparation, can solve the problems of affecting product quality and curative effect, unable to guarantee product qualification, unstable release, etc., and achieve stable drug release effect and preparation process. Ease of control and improved medication compliance

Active Publication Date: 2013-02-27
TEYI PHARMACEUTICAL GROUP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the release rate of the existing erythromycin enteric-coated preparations is unstable, and the release rate gradually decreases during storage, s

Method used

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  • Erythromycin enteric-coated tablets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] An erythromycin enteric-coated tablet, based on the preparation of 100,000 erythromycin enteric-coated tablets, the core component of the erythromycin enteric-coated tablet is 12.5 billion units of erythromycin (1 billion units / kg), corn Starch 3.4kg, tapioca starch 0.8kg, hypromellose 0.16kg, hypromellose 0.7kg, carboxymethyl starch sodium 0.7kg, magnesium stearate 0.18kg;

[0034] Enteric coating components: polyacrylic resin II 1.0kg, ethanol 13.1kg, diethyl phthalate 0.21kg, castor oil 0.42kg, polysorbate (80) 0.21kg;

[0035] Sugar coating components: 5.8 kg of sucrose, 5.8 kg of talc, 2.0 g of gelatin, 28 g of Sichuan wax, and 2.8 g of simethicone.

[0036] The preparation method is as follows:

[0037] 1. Preparation of tablet core

[0038] (1) Prepare the adhesive, dilute the tapioca starch into a suspension with cold purified water, and stir the hypromellose quickly with hot purified water, and add the hypromellose solution to the suspension In the process, ...

Embodiment 2

[0059] An erythromycin enteric-coated tablet, based on the preparation of 100,000 erythromycin enteric-coated tablets, the core components of the erythromycin enteric-coated tablet are 12 billion units of erythromycin (1 billion units / kg), corn Starch 3kg, tapioca starch 0.5kg, hypromellose 0.1kg, hypromellose 0.5kg, carboxymethyl starch sodium 0.5kg, magnesium stearate 0.1kg;

[0060] Enteric coating components: polyacrylic resin II 0.85kg, ethanol 12kg, diethyl phthalate 0.18kg, castor oil 0.3kg, polysorbate (80) 0.18kg;

[0061] Sugar coating components: 4.5 kg of sucrose, 4.5 kg of talc, 1.0 g of gelatin, 20 g of Sichuan wax, and 1.0 g of simethicone.

[0062] The preparation method is as follows:

[0063] 1. Preparation of tablet core

[0064] (1) Prepare the adhesive, dilute the tapioca starch into a suspension with cold purified water, and stir the hypromellose quickly with hot purified water, and add the hypromellose solution to the suspension In the process, 5kg of...

Embodiment 3

[0078] An erythromycin enteric-coated tablet, based on the preparation of 100,000 erythromycin enteric-coated tablets, the core components of the erythromycin enteric-coated tablet are 13.7 billion units of erythromycin (1 billion units / kg), corn Starch 3.8kg, tapioca starch 1.0kg, hypromellose 0.3kg, hypromellose 1.0kg, sodium starch glycolate 1.0kg, magnesium stearate 0.3kg;

[0079] Enteric coating components: polyacrylic acid resin II 1.15kg, ethanol 15kg, diethyl phthalate 0.24kg, castor oil 0.5kg, polysorbate (80) 0.24kg;

[0080] Sugar coating components: 7.0 kg of sucrose, 7.0 kg of talcum powder, 5.0 g of gelatin, 50 g of Sichuan wax, and 5.0 g of simethicone.

[0081] The preparation method is as follows:

[0082] 1. Preparation of tablet core

[0083] (1) Prepare the adhesive, dilute the tapioca starch into a suspension with cold purified water, and stir the hypromellose quickly with hot purified water, and add the hypromellose solution to the suspension 10kg of ...

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Abstract

The invention provides erythromycin enteric-coated tablets and a preparation method thereof. Each erythromycin enteric-coated tablet comprises a core, and an enteric coating and a sugar coating which wrap the core, wherein the core comprises effective therapeutic dose of erythromycin, corn starch, cassava starch, hydroxypropyl methylcellulose, hydroxypropylcellulose, carboxymethyl starch sodium and magnesium stearate; the enteric coating comprises polyacrylic resin II, ethanol, diethyl phthalate, castor oil and polysorbate-80; and the sugar coating comprises sucrose, talc powder, gelatin, white wax and dimeticone. The erythromycin enteric-coated tablets are stable and excellent in release degree, low in toxic or side effect and good in mouthfeel, and are stable in quality during storage; and the release degree of the tablets difficultly fluctuates together with prolonging of the storage time.

Description

technical field [0001] The invention belongs to an antibiotic drug and a preparation method thereof, in particular to an erythromycin enteric-coated preparation and a preparation method thereof. Background technique [0002] Erythromycin enteric-coated tablets are antibiotic drugs, suitable for mycoplasma pneumonia, neonatal conjunctivitis caused by Chlamydia trachomatis, infant pneumonia, genitourinary tract infection (including non-gonococcal urethritis), legionnaires' disease, diphtheria (adjuvant treatment) and diphtheria carriers, skin and soft tissue infections, whooping cough, respiratory infections (including pneumonia) caused by sensitive bacteria (influenza bacillus, pneumococcus, hemolytic streptococcus, staphylococcus, etc.), streptococcal angina, Listeria infection, rheumatism Long-term prevention of fever and prevention of endocarditis, Campylobacter jejuni enteritis, gonorrhea, syphilis, acne, etc. Because erythromycin is very sensitive to acidic media, it is...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K31/7048A61P31/04
Inventor 许丹青
Owner TEYI PHARMACEUTICAL GROUP CO LTD
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