Chloromycetin eye drops containing sulfobutyl-beta-cyclodextrins and preparation method thereof

Abstract

The present invention belongs to technical field of medicine, and relates to a chloromycetin eyedrop comprising sulfobutyl ether-beta-cyclodextrin (SBE-beta-CD) and a preparing method thereof. The chloromycetin eyedrop has excellent stability. The concentration of sulfobutyl ether-beta-cyclodextrin is 5%-10%. The preparing method comprises the following steps: weighting SBE-beta-CD, adding into boiled injection water and mixing, placing to cold after totally dissolving and adding pH modifying agent into the preparation, then adding an unimycetin with a recipe amount, heating and dissolving in a temperature below 60 DEG C, adding injection water to total amount, and filtering with a millipore filter of 0.22 mu m. The obtained preparation is embedded in the ampoule after checking to be qualified. The chloromycetin eyedrop which adopts SBE-beta-CD as packaging material has the advantages of reducing the decomposition under the conditions of light and heat, retaining the bioactivity, reducing the excitation to eye and prolonging the effective period of chloromycetin eyedrop.

Description

Technical field: [0001] The invention belongs to medical technology, and relates to a chloramphenicol eye drop and a preparation method thereof, in particular to a chloramphenicol eye drop containing sulfobutyl ether-β-cyclodextrin (SBE-β-CD) and a preparation thereof method. Background technique: [0002] Chloramphenicol eye drops, a common broad-spectrum antibiotic eye drops, is a colorless or almost colorless clear liquid. For the treatment of eye infections caused by Escherichia coli, Haemophilus influenzae, Klebsiella, Staphylococcus aureus, hemolytic streptococcus and other sensitive bacteria, such as trachoma, conjunctivitis, keratitis, blepharitis, etc. . Chloramphenicol is relatively stable in neutral and weakly acidic solutions, but light, heat, and the pH of the medium all affect its stability. During production and storage, it is hydrolyzed to produce 1-(4-nitrophenyl)-2-amino -1,3-propanediol (referred to as diol), which reduces the antibacterial activity. T...

AI Technical Summary

Problems solved by technology

However, because chloramphenicol is slightly soluble in water, especially adding substances such as sodium hyaluronate to increase the viscosity of the solution to improve bioavailability, the dissolution rate will decrease

Therefore, after the chloramphenicol drop pill is put into the solution, it needs to be shaken for a long time to dissolve, which affects the patient's compliance with the drug.

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