Preparation method of eye drops

Abstract

The invention discloses a preparation method of eye drops, and the eye drops comprise a voriconazole solution clathrated by sulfobutyl-beta-cyclodextrin. The preparation method of the voriconazole solution clathrated by sulfobutyl-beta-cyclodextrin comprises the following steps: 1, dissolving voriconazole with an acid solution to obtain a solution A; 2, dissolving sulfobutyl-beta-cyclodextrin by using water for injection to obtain a solution B; 3, adding the solution A into the solution B under room-temperature stirring or ultrasonic conditions to obtain a mixed system; 4, stirring the mixed system in the step 3 at room temperature to obtain the voriconazole solution included by the sulfobutyl-beta-cyclodextrin. According to the voriconazole oral liquid, the voriconazole solution included by the sulfobutyl-beta-cyclodextrin serves as a main component, the defect that voriconazole is poor in water solubility can be effectively overcome, the voriconazole oral liquid is non-toxic and non-irritant to ocular surfaces and has an obvious sterilization and bacteriostasis effect on various common clinical fungi, the content of the voriconazole oral liquid can still be kept at about 98.3% after the voriconazole oral liquid is placed for two years, and the voriconazole oral liquid has high stability and clarity.

Description

technical field [0001] The invention belongs to the technical field of ophthalmic preparations, and in particular relates to a preparation method of eye drops. Background technique [0002] Fungal keratitis is an infectious corneal disease caused by pathogenic fungi with an insidious course and a high blinding rate. With the widespread use of broad-spectrum antimicrobials, glucocorticoids, and antiviral drugs in clinical practice, the incidence of fungal keratitis in China is increasing year by year. There are as many as 56 genera and 105 species of bacteria that can cause ocular corneal infection. According to epidemiological statistics and retrospective analysis of pathogenic bacteria spectrum, it is found that the pathogenic bacteria of common fungal infections in China are: Fusarium, Aspergillus, Candida, Penicillium and Saccharomyces, of which Fusarium and Aspergillus The genus is the most common pathogen, and the incidence of Alternaria has been increasing in recent ...

AI Technical Summary

Problems solved by technology

The present invention uses sulfobutyl-β-cyclodextrin inclusion voriconazole solution as the main component, which can effectively solve technical problems such as poor water solubility of voriconazole, and the content of the prepared eye drops can still be kept at about 98.3% after two years of storage. The quality is controllable, with high stability and clarity. Animal experiments have shown that it is non-toxic and non-irritating to the ocular surface; drug sensitivity tests have shown that it has obvious bactericidal and bacteriostatic effects on a variety of common fungi in clinical treatment, which can effectively enrich clinical Variety of drugs for the treatment of fungal keratitis, increasing drug selectivity

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