Stable moxixacin tablet and its prepn process

Abstract

The present invention relates to stable moxixacin tablet and its preparation process. The preparation contains moxixacin or its salt and / or hydrate and tablet supplementary material. The present invention features that during preparation, hypromellose or other filming material may be added to prepare granule before tabletting so that the medicine is stable without color change during pelletizing and tabletting.

Description

technical field [0001] The invention relates to a stable tablet of moxifloxacin or its salt and / or its hydrate and a preparation method thereof. Background technique [0002] Moxifloxacin is a new generation of fluoroquinolone antibacterial drugs, which are currently approved abroad for upper and lower respiratory tract infections caused by sensitive microorganisms, such as acute exacerbation of chronic bronchitis, community-acquired pneumonia, acute bacterial sinusitis and uncomplicated Treatment of skin and soft tissue infections. [0003] Moxifloxacin hydrochloride tablets were first registered in Mexico in February 1999, and listed in Germany in September 1999. The infusion solution was first listed in the United States and Germany in December 2001. At present, the product has been sold in Germany, Spain, Italy, and Sweden , Switzerland, the United States, Canada, Australia, Argentina, Brazil, South Korea, Malaysia and other countries. [0004] Patent literature (Chine...

AI Technical Summary

Problems solved by technology

[0011] In addition, during the compression process of the above-mentioned three-prescription tablets, it was found that the edges of the tablets often showed obvious red color, indicating that new impurities were produced

[0012] At present, there are no reports on the pharmacological and toxicological effects of the moxifloxacin hydrochloride raw material or the red impurities produced during the tableting process, and it cannot be predicted that it is harmless to the human body