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Dirithromycin enteric-coated tablet enteric coating, preparation method thereof and dirithromycin enteric-coated tablet

An enteric coating, dirithromycin technology is applied in the directions of pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. There are large differences within batches and uneven levels of domestic enteric-coated preparations to achieve the effects of improving stability, uniform release, and safe preparation methods.

Active Publication Date: 2019-06-18
湖北舒邦药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, dirithromycin is also very sensitive to acidic media and is easily degraded into erythrocycline, which greatly reduces its bioavailability and oral characteristics
In addition, the reference preparations still available on the market show large inter-batch and intra-batch differences, and the level of domestic enteric-coated preparations is uneven

Method used

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  • Dirithromycin enteric-coated tablet enteric coating, preparation method thereof and dirithromycin enteric-coated tablet
  • Dirithromycin enteric-coated tablet enteric coating, preparation method thereof and dirithromycin enteric-coated tablet
  • Dirithromycin enteric-coated tablet enteric coating, preparation method thereof and dirithromycin enteric-coated tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] 250mg dirithromycin enteric-coated tablets

[0051] Dirithromycin Tablets 745mg

[0052] Dirithromycin gown tablet 767.35mg

[0053] Enteric layer

[0054]

[0055]

[0056] The preparation method of dirithromycin enteric-coated tablet is as follows:

[0057] (a) Weigh the isolation coat coating powder according to the formula, add the isolation coat coating powder into 80% ethanol solution, stir and shear at a high speed to a dispersed state, and obtain the coating liquid I;

[0058] (b) Place the dirithromycin tablet in a coating machine for preheating, 2-4 rpm, preheat at 40°C, coat the coating liquid I evenly on the surface of the dirithromycin tablet, Make the coating solution uniformly grow and dry on the surface of the tablet, and finally dry fully to form dirithromycin isolation-coated tablets;

[0059] (c) Place the dirithromycin isolation-coated tablet in a coating machine to continue drying at 2-8 rpm at 40°C, dissolve titanium dioxide and triethyl ...

Embodiment 2

[0061] 250mg dirithromycin enteric-coated tablets

[0062] Dirithromycin Tablets 745mg

[0063] Dirithromycin gown tablet 774.8mg

[0064] Enteric layer

[0065]

[0066] Step is with embodiment 1.

Embodiment 3

[0068] 250mg dirithromycin enteric-coated tablets

[0069] Dirithromycin Tablets 745mg

[0070] Dirithromycin gown tablet 767.35mg

[0071] Enteric layer

[0072]

[0073] Step is with embodiment 1.

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Abstract

The invention provides a dirithromycin enteric-coated tablet enteric coating. The dirithromycin enteric-coated tablet enteric coating is prepared from the following components in parts by weight: 60-70% of methacrylic acid-acrylate copolymer aqueous dispersion, 2-5% of titanium dioxide, 15-35% of triethyl citrate and 0-0.5% of talcum powder. The invention further provides a preparation method andprocess of the dirithromycin enteric-coated tablet enteric coating. The characteristic of uniform and stable release is achieved while stability of a dirithromycin enteric preparation is improved, thedirithromycin enteric-coated tablet enteric coating achieves the better similarity to a reference preparation, namely Dynabac in dissolution behavior, thus the domestic dirithromycin enteric preparation is broken through, and foreign post-marketing drugs are effectively substituted.

Description

technical field [0001] The application belongs to the technical field of medicines, and more specifically, the application relates to an enteric-coated dirithromycin enteric-coated tablet, a preparation method thereof and a dirithromycin enteric-coated tablet. Background technique [0002] Dirithromycin is authorized by Lilly Company of the United States and is listed in Spain, the United States and European countries. Dirithromycin is a macrolide antibiotic and a prodrug of erythromycin. Its mechanism of action is to inhibit protein synthesis by binding to the 50S ribosomal subunit of sensitive microorganisms. It is suitable for patients over 12 years old, and is used to treat mild and moderate infections caused by sensitive bacteria such as Influenza rod, Moraxella catarrhalis, Streptococcus pneumoniae, and acute exacerbation of chronic bronchitis. Dirithromycin has an antibacterial spectrum similar to that of erythromycin, and is characterized by excellent pharmacokineti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/32A61K47/32A61K47/14A61K47/02A61K31/706A61P31/04
CPCY02A50/30
Inventor 李守明龚明峰黄晶马泽秀肖科军
Owner 湖北舒邦药业有限公司
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