Studies on voriconazole sulfobutyl ether beta cyclodextrin eye drops and eye irritation test
Objective To prepare 1% voriconazole eye drops, establish its method of quality control and inspect the eye irritation. Methods Voriconazole was solubilizing by SBE-β-CD in order to prepare voriconazole eye drops. The content of voriconazole was determined by HPLC, observed stability and irritation to rabbits'eyes of voriconazole eye drops. Results The eye-drops was colorless and transparent liquid, specification of 5 mL: 50 mg, content of voriconazole was 1%. Its identification and test conformed to the related standards stated in Ch.P(2015). There was a good linear relationshop with the concentration range of 20~800μg/mL(r=0.9999, n=6)for voriconazole, and its average recovery was 100.13%(RSD=0.78%, n=9). Both intra- and inter-day precision RSD were less than 2%(n=5). The eye drops had no irritation to rabbits'eyes, accelerated stability test is good. Conclusion The preparation process of voriconazole eye drops is simple, its quality control method is reliable.
voriconazoleeye dropsSBE-β-CDquality controlirritation test
NETL
NSTL
万方数据
维普
