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Erythromycin enteric-coated tablet and preparation method thereof

A technology of erythromycin and enteric-coated tablets, which is applied in the field of medicine, can solve problems such as unstable release, poor bioavailability, and reduced release, and achieve quality assurance and curative effect, uniform coating layer, and stable release. Effect

Inactive Publication Date: 2017-07-07
XIAN LIJUN PHARMA CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] There are certain defects in the structural characteristics of erythromycin. Its C-6, C-12 hydroxyl, and C-9 carbonyl can form an acetal structure under acid catalysis, and it is unstable under acidic conditions. It is easy to decompose and lose activity below pH 6. , so it is easily destroyed by gastric acid and loses its effect when taken orally, resulting in poor bioavailability and difficult dosage, etc. Therefore, it is usually prepared into enteric-coated preparations
At present, the release rate of the existing erythromycin enteric-coated preparations is unstable, and the release rate gradually decreases during storage, so that the product cannot be guaranteed to be qualified within the validity period, which seriously affects the quality and curative effect of the product
[0004] Moreover, the existing erythromycin enteric coatings all use organic solvent coatings, and the use of organic solvent coatings will bring a series of problems in terms of environment, economy and safety.

Method used

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  • Erythromycin enteric-coated tablet and preparation method thereof
  • Erythromycin enteric-coated tablet and preparation method thereof
  • Erythromycin enteric-coated tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] The prescription is as follows:

[0036]

[0037]

[0038] Preparation:

[0039] (1) Prepare the adhesive: dissolve povidone with purified water, and then add the prescribed amount of sodium citrate to dissolve.

[0040] (2) Pour erythromycin and microcrystalline cellulose into a wet granulator and mix evenly according to the prescription ratio, add the binder prepared in (1) according to the prescription ratio, and stir to make wet granules.

[0041] (3) Dry the prepared wet granules in a fluidized dryer until the moisture content is 4.5% to 6.5%, and then granulate with a granulator.

[0042] (4) Add croscarmellose sodium, crospovidone, colloidal silicon dioxide, magnesium stearate and the granules prepared in (3) into the mixer according to the prescription ratio and mix to obtain enteric-coated tablets Uniform particles.

[0043] (5) Tablet compression, using a tablet press to compress tablets to obtain tablet cores.

[0044] Carry out the package isolatio...

Embodiment 2

[0050] The prescription is as follows:

[0051]

[0052]

[0053] Preparation:

[0054] (1) Prepare the adhesive: dissolve povidone with purified water, and then add the prescribed amount of sodium citrate to dissolve.

[0055] (2) Pour erythromycin and microcrystalline cellulose into a wet granulator and mix evenly according to the prescription ratio, add the binder prepared in (1) according to the prescription ratio, and stir to make wet granules.

[0056] (3) Dry the prepared wet granules in a fluidized dryer until the moisture content is 4.5% to 6.5%, and then granulate with a granulator.

[0057] (4) Add croscarmellose sodium, crospovidone, colloidal silicon dioxide, magnesium stearate and the granules prepared in (3) into the mixer according to the prescription ratio and mix to obtain enteric-coated tablets Uniform particles.

[0058](5) Tablet compression, using a tablet press to compress tablets to obtain tablet cores.

[0059] Package isolation layer:

[00...

Embodiment 3

[0065] The prescription is as follows:

[0066]

[0067] Preparation:

[0068] (1) Prepare the adhesive: dissolve povidone with purified water, and then add the prescribed amount of sodium citrate to dissolve.

[0069] (2) Pour erythromycin and microcrystalline cellulose into a wet granulator and mix evenly according to the prescription ratio, add the binder prepared in (1) according to the prescription ratio, and stir to make wet granules.

[0070] (3) Dry the prepared wet granules in a fluidized dryer until the moisture content is 4.5% to 6.5%, and then granulate with a granulator.

[0071] (4) Add croscarmellose sodium, crospovidone, colloidal silicon dioxide, magnesium stearate and the granules prepared in (3) into the mixer according to the prescription ratio and mix to obtain enteric-coated tablets Uniform particles.

[0072] (5) Tablet compression, using a tablet press to compress tablets to obtain tablet cores.

[0073] Pack isolation layer and enteric coating t...

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PUM

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Abstract

The present invention provides an erythromycin enteric-coated tablet and a preparation method thereof. The erythromycin enteric-coated preparation has stable release rate. During storage, stable release rate ensures quality and efficacy of the product. As for the enteric coating, an ammonia-neutralized enteric-coated cellulose aqueous polymer solution coating system is adopted for coating, and there will be no film adhesion problems. The final product has smooth surface and uniform coating layer. A series of questions caused by organic solvent coatings are avoided.

Description

technical field [0001] The invention belongs to the field of medicine, in particular to an erythromycin enteric-coated tablet and a preparation method thereof. Background technique [0002] Erythromycin is mainly used clinically for tonsillitis caused by streptococcus, scarlet fever, diphtheria and carriers, gonorrhea, listeriosis, and lower respiratory tract infection caused by Streptococcus pneumoniae. It can also be used in upper respiratory tract infections caused by influenza bacilli, skin and soft tissue infections caused by Staphylococcus aureus, syphilis, and intestinal amoebiasis. [0003] There are certain defects in the structural characteristics of erythromycin. Its C-6, C-12 hydroxyl, and C-9 carbonyl can form an acetal structure under acid catalysis, and it is unstable under acidic conditions. It is easy to decompose and lose activity below pH 6. , so it is easily destroyed by gastric acid and loses its effect when taken orally, resulting in poor bioavailabili...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/7048A61K47/38A61P31/04
CPCA61K9/2027A61K9/2054A61K9/2813A61K9/282A61K9/2866A61K9/2886A61K31/7048
Inventor 俞仑连桂云李晨
Owner XIAN LIJUN PHARMA CO LTD
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