Azithromycin soft capsules and preparation method thereof

Abstract

The invention discloses azithromycin soft capsules and a preparation method thereof. The soft capsules comprise the following raw material components: azithromycin, polyethylene glycol 400, polyethylene glycol 200, water, acetic acid, 1,2-propanediol and the like. The soft capsules are prepared through the steps of stirring, pressing and the like in the preparation process. Experiments show that the azithromycin soft capsule preparations prepared by the preparation method have stable solution without precipitate, and particularly the acetic acid replaces the commonly used lactic acid, citric acid or lactobionic acid and other cosolvents, and the conventional process is changed by adding water in the process of preparing the soft capsules, and thus the content of the prepared soft capsule has no precipitate, is completely dissolved and has good stability to ensure the quality of the content of the capsule.

Description

technical field [0001] The invention relates to a soft capsule and a preparation method thereof, in particular to an azithromycin soft capsule and a preparation method thereof. Background technique [0002] Azithromycin is a 15-ring macrolide antibiotic that inhibits bacterial protein synthesis by hindering the bacterial transpeptide process. In vitro experiments have proved that azithromycin is effective against a variety of common clinical pathogens, including Gram-positive aerobic bacteria: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, α-hemolytic streptococci and other streptococci, diphtheria bacilli. [0003] Azithromycin used clinically is all tablets, which have an abnormal bitter taste when taken, and are not stable enough. They all show different degrees of quality change under high temperature or humid conditions. At present, there is no azithromycin soft capsule that can reach the liquid content of the capsule. Stable without precipit...

AI Technical Summary

Problems solved by technology

[0003] Azithromycin used clinically is all tablets, which have an abnormal bitter taste when taken, and are not stable enough. They all show different degrees of quality change under high temperature or humid conditions. At present, there is no azithromycin soft capsule that can reach the liquid content of the capsule. Stable without precipitation, and the preparation process of azithromycin soft capsules disclosed in the prior art cannot be realized and the stability is poor