Objective To investigate the current situation and analyze the existing problems with the antimicrobial preservative in domestic gentamicin sulfate eye drops.Methods In order to evaluate the rationality of the antimicrobial preservative to be added to gentamicin sulfate eye drops,23 batches of domestic gentamicin sulfate eye drops were analyzed by a newly established quantitative method for antimicrobial preservatives.The influence factor test,compatibility of antimicrobial preservative,and packaging material were also studied.Results The content of ethyparaben in gentamicin sulfate eye drops would decrease with the reduction of residual validity periods.Besides,it was proven that ethyparaben would be absorbed by low-density polyethylene bottles for eye drops.Conclusion Some problems existed with the usage of antimicrobial preservatives,such as hydroxyphenyl ethyl ester,in domestic gentamicin sulfate eye drops.It was suggested that enterprises should pay attention to the screening type and dosage of antimicrobial preservatives,ensure the stability of preservatives,and improve packing materials so as to guarantee the safety and effectiveness of the product.
关键词
硫酸庆大霉素滴眼液/抑菌剂/低密度聚乙烯滴眼剂瓶/羟苯乙酯
Key words
Gentamicin sulfate eye drops/Antimicrobial preservatives/Low-density polyethylene bottles for eye drops/Ethyparaben
维普
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