Azithromycin enteric-coated pellet capsule and preparation method thereof

Abstract

The invention relates to an azithromycin enteric-coated pellet capsule and a preparation method thereof. The capsule comprises azithromycin mixed preparation auxiliary material which is loaded into a pellet core to form a pellet pill that is covered by isolation coating material to form an isolation layer and covered by enteric-coated material to form an enteric-coated layer. The invention azithromycin enteric-coated pellet capsule solves the problems in the background technology, can be dissolved and absorbed in intestinal tract, is rapidly and evenly dispersed in the intestinal tract after entering into the intestinal tract, and effectively improves the bioavailability of medicine. The invention also provides the preparation method of the azithromycin enteric-coated pellet capsule.

Description

technical field [0001] The invention relates to azithromycin pellet preparation, in particular to an azithromycin enteric-coated pellet capsule and a preparation method thereof. Background technique [0002] Azithromycin was first created by Plina Pharmaceutical Company and developed and marketed by Pfizer Pharmaceutical Company of the United States. Azithromycin and erythromycin have commonalities in chemical structure and mechanism of action, but their biological characteristics are completely different. Azithromycin has the advantages of high concentration in tissues and cells at the site of infection, significant curative effect, good safety and tolerance, and has a good clinical prospect. [0003] Because azithromycin is unstable in gastric juice, there is almost no prototype in artificial gastric juice (PH=1.3) for 10 minutes; according to literature reports, the amount of azithromycin degraded into declardinose after oral administration of azithromycin is about 15% of...

AI Technical Summary

Problems solved by technology

[0003] Because azithromycin is unstable in gastric juice, there is almost no prototype in artificial gastric juice (PH=1.3) for 10 minutes; according to literature reports, the amount of azithromycin degraded into declardinose after oral administration of azithromycin is about 15% of the administered dose, After intravenous injection of the same dose of azithromycin, the amount of declaridine azithromycin is less than 0.5% of the administered dose, which further proves that gastric acid has a destructive effect on azithromycin, resulting in a low bioavailability of azithromycin common oral preparations, about 37%~ 46%, thus affecting the clinical efficacy of azithromycin

[0004] Chinese patent 200410036629.8 discloses an enteric-coated preparation of azithromycin and its preparation method. Although this patent provides an enteric-coated preparation of azithromycin, common enteric-coated preparations tend to stick together in the enteric coating, resulting in uneven drug distribution. low bioavailability