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Preparation method of sitafloxacin hydrate granule composition

A technology of sitafloxacin and composition, which is applied in the field of preparation of sitafloxacin granule composition, can solve the problem of no granules and the like, and achieve the effects of low cost and simple preparation process

Inactive Publication Date: 2013-03-27
QINGDAO CENT HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There are no reports of granules

Method used

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Examples

Experimental program
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Effect test

Embodiment 1

[0019] The preparation methods of no bitter sitafloxacin granule composition, it comprises the following steps: (1) preparation concentration is the carrageenan solution of 5%: get carrageenan 10g, add 200m1 hot water to make dissolving, cool to room temperature, use 0.1 mo1 / L sodium hydroxide solution to adjust the pH to 5.5, for later use; weigh 105g of sitafloxacin, add carrageenan solution, make it wet and repeat the granulation in a swinging granulator, dry for 4 hours, and pulverize to make west Tafloxacin carrageenan granule; (2) preparation concentration is 5% sodium chloride solution 25ml, adjusts pH to be 8.5 with 0.1mol / L sodium hydroxide solution, standby; Sitafloxacin in step (1) Add sodium chloride solution to the carrageenan granules, make it wet and solidify, dry at 65°C for 4 hours, and prepare sitafloxacin inclusion compound; (3) Weigh 2kg sucrose, 200g starch, 15g sodium carboxymethylcellulose, Dry blending in a mixing granulator for 500-600 seconds, adding ...

Embodiment 2

[0021] The preparation methods of the sitafloxacin granule composition without bitterness, it comprises the following steps: (1) preparation concentration is the carrageenan solution of 10%: get carrageenan 20g, add 200m1 hot water to make dissolving, cool to room temperature, use 0.1 mo1 / L sodium hydroxide solution to adjust the pH to 5, set aside; weigh 100g of sitafloxacin, add carrageenan solution to make it wet and repeat the granulation in a swinging granulator, dry for 5 hours, and pulverize to make west Tafloxacin carrageenan granule; (2) preparation concentration is 10% sodium chloride solution 25m1, regulates pH to be 9 with 0.1mol / L sodium hydroxide solution, for subsequent use; Sitafloxacin in step (1) Add sodium chloride solution to the carrageenan granules, make it wet and solidify, dry at 75°C for 5 hours, and prepare sitafloxacin inclusion compound; (3) Weigh 1.5kg sucrose, 200g starch, and 12g sodium carboxymethyl cellulose, Dry mix in a wet mixing granulator ...

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PUM

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Abstract

The invention relates to a preparation method of a sitafloxacin hydrate granule composition, belonging to the technical field of Western medicine prepration. The sitafloxacin hydrate granule composition is formed by a base tablet and a coating, and is prepared into a sitafloxacin hydrate inclusion compound by adopting carrageenan. The sitafloxacin hydrate granule composition does not have bitter taste.

Description

technical field [0001] The invention belongs to the technical field of western medicine preparations, in particular to a preparation method of sitafloxacin granule composition. Background technique [0002] Sitafloxacin (DU 6859A) is a new oral N1-fluorocyclopropyl quinolone antibiotic, which has strong antibacterial activity against methicillin-resistant Staphylococcus aureus, Pseudomonas and Bacteroides sp. The chemical name is 7-(7S)-amino-5-azaspiro[2,4]heptan-5-l]-8-chloro-6-fluoro-1-[(1R,2S)-2-fluoro-1-cyclopropyl ]-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid sesquihydrate, the molecular formula is C19H18ClF2N3O3, the CAS number is 127254-12-0, the compound contains cis (1R,2S)-2-fluorocyclopropylamine group, the group Reduction of adverse reactions and better pharmacokinetic properties of sitafloxacin are necessary. Oral and injectable dosage forms are undergoing Phase III clinical trials in Japan by Daiichi Pharmaceutical Co., Ltd. for the treatment of bacterial i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/4709A61K47/36A61P31/04
Inventor 不公告发明人
Owner QINGDAO CENT HOSPITAL
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