Moxifloxacin hydrochloride tablets for preventing color change and cracking and preparation method thereof

Abstract

The invention provides moxifloxacin hydrochloride tablets for preventing color change and cracking. The tablets contain 20 to 45 percent of filling agent such as ethyl cellulose polymer, and are prepared by adopting a direct tabletting process. The moxifloxacin hydrochloride tablets do not change color in the preparation process, and are stable in weight and high in dissolution; the weight difference and the friability of the tablets reach the pharmacopoeia requirements; and the labor cost and the production cost are reduced, the production efficiency is improved, and the tablets have good industrial application value.

Description

technical field [0001] The invention relates to a moxifloxacin hydrochloride tablet, in particular to a moxifloxacin hydrochloride tablet which prevents problems such as discoloration, cracks and loose flakes. The invention also relates to the preparation of moxifloxacin hydrochloride tablets by adopting a direct tableting process. Background technique [0002] Moxifloxacin hydrochloride is a fluoroquinolone antibacterial drug, which can undergo a complex reaction with iron ions to produce red impurities. During the preparation process, the material containing moxifloxacin hydrochloride will change from yellow to red. Under these conditions, the reaction rate is greatly increased, which not only causes corrosion to the production equipment, but also leads to a decrease in the effective drug content. [0003] In order to solve the discoloration problem of moxifloxacin hydrochloride during the preparation process, patent CN200510021736 uses film-forming materials (hydroxyprop...

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