Sitafloxacin tablet and preparation method thereof

Abstract

The invention relates to a sitafloxacin tablet and a preparation method thereof. Common opacifying agent ferric oxide is added in the crystallization and purification process of a crude product of the sitafloxacin tablet, so the purification time of the sitafloxacin tablet can be effectively shortened, and the effect of the ferric oxide serving as the opacifying agent is not influenced; moreover, the refined sitafloxacin powder is added step by step and is ground together with one to two times of mannitol, so the finally formed tablet has good dissolution rate under the condition of using a small amount of mannitol, and meanwhile, the taste of the tablet can be adjusted through the mannitol, so that the compliance of a patient is improved.

Description

technical field

[0001] The invention relates to the technical field of pharmacy, in particular to a sitafloxacin tablet and a preparation method thereof. Background technique

[0002] Sitafloxacin hydrate is a broad-spectrum quinolone antibacterial drug developed by Daiichi Sankyo, and its monohydrate is clinically used for the treatment of severe and refractory infectious diseases.

[0003] Sitafloxacin tastes bitter and is insoluble in water. Therefore, direct wet or dry granulation will lead to very unsatisfactory dissolution rate of active ingredients in solid preparations, and the extremely bitterness will lead to poor patient compliance.

[0004] Application number 201310013310.2 discloses a sitafloxacin tablet and its preparation method, that is, sitafloxacin or its pharmaceutically acceptable salt and pellet excipients are made of soft material with ethanol aqueous solution and then extruded and spheronized to prepare drug-containing pellets , and then add the prepa...

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