Prulifloxacin oral solid composition and preparation method thereof

A technology of prulifloxacin and composition, applied in the field of pharmaceutical compositions and preparation thereof, can solve the problems of unfavorable patient medication safety, slow drug dissolution rate, influence on drug absorption, etc., and achieves improved medication safety, good dissolution rate, antibacterial Broad spectrum effect
CN102895175AActive Publication Date: 2013-01-30SICHUAN KELUN PHARMA CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
SICHUAN KELUN PHARMA CO LTD
Publication Date
2013-01-30

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Abstract

The invention discloses a prulifloxacin oral solid composition and a preparation method thereof. The prulifloxacin oral solid composition is prepared from 130 to 135 parts by weight of prulifloxacin, 10 to 30 parts by weight of starch, 30 to 50 parts by weight of microcrystalline cellulose, 20 to 40 parts by weight of lactose, 0.05 to 10 parts by weight of one or more binders, 2 to 15 parts by weight of one or more disintegrants and 0.5 to 10 parts by weight of one or more lubricants. The one or more binders are selected from polyvinylpyrrolidone, lauryl sodium sulfate and polyethylene glycol mixed aqueous solutions or alcoholic solutions. The one or more disintegrants are selected from carboxymethyl starch sodium, polyvinylpolypyrrolidone and hydroxy propyl cellulose. The one or more lubricants are selected from magnesium stearate, calcium stearate and aerosil. The prulifloxacin oral solid composition can be processed into tablets, capsules or granules, has good stability, can effectively improve a dissolution rate, solves the problem that the existing prulifloxacin oral solid preparation has a slow dissolution speed, and improves bioavailability.
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Description

technical field

[0001] The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a prulifloxacin oral solid preparation and a preparation method thereof. Background technique

[0002] Prulifloxacin (PUFX) is a fourth-generation fluoroquinolone antibacterial drug and a prodrug of the metabolically active substance UFX (codenamed NM394). Nippon Shinyaku (Co., Ltd.) was the first to develop and enter preclinical research, and then Meiji Seika (Co., Ltd.) joined in preclinical and clinical joint research; and Japan Shinyaku (Co., Ltd.) cooperated with Shiquan Chemical Co., Ltd. Carry out research on its raw materials.

[0003] After oral administration, prulifloxacin is mainly absorbed by the small intestine, and 5-methyl-2-oxo-1,3-dioxole-4 at the C7 position is removed under the action of dioxygenase in the portal vein and liver - group, became NM394 (AF3013) with antibacterial activity. It has a wide antibacterial spectrum and...

Claims

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