A kind of enteric coating of dirithromycin enteric-coated tablet, its preparation method and a kind of dirithromycin enteric-coated tablet

A technology of dirithromycin tablets and dirithromycin is applied in the directions of pharmaceutical formulations, medical preparations with non-active ingredients, and medical preparations containing active ingredients, etc. The level of enteric-coated preparations is uneven, the bioavailability and oral characteristics are reduced, etc., to achieve uniform release, improved stability, and safe preparation methods.

Active Publication Date: 2022-07-12
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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  • A kind of enteric coating of dirithromycin enteric-coated tablet, its preparation method and a kind of dirithromycin enteric-coated tablet
  • A kind of enteric coating of dirithromycin enteric-coated tablet, its preparation method and a kind of dirithromycin enteric-coated tablet
  • A kind of enteric coating of dirithromycin enteric-coated tablet, its preparation method and a kind of dirithromycin enteric-coated tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0050] 250mg dirithromycin enteric-coated tablet

[0051] Dirithromycin Tablets 745mg

[0052] Dirithromycin Isolation Coat 767.35mg

[0053] Enteric layer

[0054]

[0055]

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

[0057] (a) take by weighing the barrier coat coating powder according to the formula, add the barrier coat coating powder to the 80% ethanol solution, stir and shear at a high speed to a dispersed state to obtain coating solution I;

[0058] (b) preheating the dirithromycin tablet in a coating machine, 2-4 rpm, preheating at 40°C, and uniformly coating the surface of the dirithromycin tablet with the coating solution I, The coating liquid is uniformly grown and dried on the surface of the tablet, and the final drying is sufficient to form dirithromycin isolation-coated tablets;

[0059] (c) placing the dirithromycin barrier coat tablet in a coating machine and continuing to dry, drying at 2-8 rev / min at 40° C....

Embodiment 2

[0061] 250mg dirithromycin enteric-coated tablet

[0062] Dirithromycin Tablets 745mg

[0063] Dirithromycin Isolation Coat 774.8mg

[0064] Enteric layer

[0065]

[0066] The steps are the same as in Example 1.

Embodiment 3

[0068] 250mg dirithromycin enteric-coated tablet

[0069] Dirithromycin Tablets 745mg

[0070] Dirithromycin Isolation Coat 767.35mg

[0071] Enteric layer

[0072]

[0073] The steps are the same as in Example 1.

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Abstract

The application provides an enteric coating for dirithromycin enteric-coated tablets, comprising the following components in parts by weight: methacrylic acid-acrylate copolymer aqueous dispersion 60-70%; titanium dioxide 2-5%; citric acid Triethyl ester 15‑35%, talc 0‑0.5%. The preparation method and coating process thereof are also provided. While improving the stability of dirithromycin enteric-coated preparations, it achieves the characteristics of uniform and stable release, and achieves a better similarity to the dissolution behavior of the reference preparation Dynabac, thus achieving a breakthrough in domestic dirithromycin enteric-coated preparations , to effectively replace foreign listed drugs.

Description

technical field [0001] The application belongs to the technical field of medicines, and more specifically, the application relates to an enteric coating for dirithromycin enteric-coated tablets, a preparation method thereof, and a dirithromycin enteric-coated tablet. Background technique [0002] Dirithromycin is authorized by Lilly Company of the United States and 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 for the treatment of mild to moderate infections caused by sensitive bacteria such as influenza bacillus, Moraxella catarrhalis, Streptococcus pneumoniae, acute exacerbation of chronic bronchitis and other diseases. Dirithromycin has an antibacterial spectrum similar to erythromycin, which is characterized by excellen...

Claims

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Application Information

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Patent Type & Authority Patents(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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