Ciprofloxacin hydrochloride oral solid preparation

Abstract

The invention relates to a ciprofloxacin hydrochloride oral solid preparation and a preparation process thereof. The preparation is prepared from ciprofloxacin hydrochloride, microcrystalline cellulose, povidone, poloxamer, a disintegrating agent and a lubricating agent, and is prepared by dissolving ciprofloxacin hydrochloride, microcrystalline cellulose, povidone and poloxamer in water, performing spray drying, uniformly mixing the obtained drug-containing particles with the disintegrating agent and the lubricating agent, and filling capsule shells or tabletting. The preparation prepared bythe invention is stable, and can effectively avoid the problem that ciprofloxacin hydrochloride is complexed with metal ions to form yellow spots.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a solid oral preparation containing ciprofloxacin hydrochloride and a preparation process thereof. Background technique [0002] The chemical name of ciprofloxacin hydrochloride is: l-cyclopropyl-6-fluoro-1,4.dihydro.4.oxo-7-(1-piperazinyl)-3-quinolinecarboxylate hydrochloride Molecular formula: C 17 h 18 FN 3 o 3 HCL has broad-spectrum antibacterial effect, especially high antibacterial activity against aerobic Gram-negative bacilli, and has good antibacterial effect on the following bacteria in vitro: most bacteria of Enterobacteriaceae, including Citrobacter, cloacae, production Enterobacter aerogenes, Escherichia coli, Klebsiella, Proteus, Salmonella, Shigella, Vibrio, Yersinia, etc. It also has antibacterial activity against multi-drug resistant bacteria. Penicillin-resistant Neisseria gonorrhoeae, Haemophilus influenzae and Moraxella spp. have high...

AI Technical Summary

Problems solved by technology

[0003] However, in the process of preparing ciprofloxacin hydrochloride tablets or capsules, since ciprofloxacin hydrochloride belongs to quinolones, the carboxyl and ketone groups in the 3 and 4 positions in its structure are easily complexed with metal ions to form macula. lead to decreased efficacy

[0004] CN108567754A discloses ciprofloxacin hydrochloride tablets, including ciprofloxacin hydrochloride, calcium carbonate, D-glucosamine sulfate potassium salt and starch, although it can be pretreated under low temperature environment, it reduces the heat source of ciprofloxacin hydrochloride raw material Risk, but because starch and other excipients contain a large amount of metal ions, macula appears on the drug granules before compression

[0005] CN107669645A discloses a preparation method of ciprofloxacin hydrochloride tablets, using ciprofloxacin hydrochloride as the main ingredient, with fillers, disintegrants and lubricants as auxiliary materials, and adopting a powder direct compression process to obtain the hydrochloric acid Ciprofloxacin tablets; the filler is a mixture of one or both of lactose or microcrystalline cellulose and starch; the disintegrant is crospovidone or low-substituted hydroxypropyl cellulose One or two of them, although the powder direct compression process has better solved the shortcomings of ciprofloxacin hydrochloride tablets, such as easy splitting, sticking and punching, and large differences in dissolution rate, but because the auxiliary materials used contain metal ions, there is still no Solve the problem of ciprofloxacin hydrochloride complexing with metal ions to form macula

Adopt the adjuvant that has metal ion such as carboxymethyl starch sodium, magnesium stearate etc. in the embodiment, still cause macula to appear in granule

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