国产硫酸庆大霉素滴眼液中抑菌剂的使用现状分析  

Analysis of antimicrobial preservative used in domestic gentamicin sulfate eye drops

作　　者：梅芊 张婷婷 李倚天 李洁 刘英 Mei Qian;Zhang Tingting;Li Yitian;Li Jie;Liu Ying(Henan Provincial Institute for Drug and Medical Device Control,Henan Chemical Quality Evaluation and Control Engineering Technology Research Center,Zhengzhou 450018)

机构地区：[1]河南省药品医疗器械检验院,河南省化学药品质量评价与控制工程技术研究中心,郑州450018

出　　处：《中国抗生素杂志》2024年第9期1019-1024,共6页Chinese Journal of Antibiotics

摘　　要：目的分析国产硫酸庆大霉素滴眼液中抑菌剂使用现状及存在的问题。方法采用新建的硫酸庆大霉素滴眼液中抑菌剂含量测定方法,结合抑菌剂影响因素试验、抑菌剂与包材的相容性对23批次国产硫酸庆大霉素滴眼液中的抑菌剂进行检测,分析该产品中抑菌剂使用的合理性。结果硫酸庆大霉素滴眼液中羟苯乙酯的含量随产品剩余效期减少而降低,产品使用的低密度聚乙烯滴眼剂瓶对抑菌剂羟苯乙酯存在吸附作用。结论目前国产硫酸庆大霉素滴眼液中抑菌剂羟苯乙酯的使用存在一定问题,建议企业重视处方中抑菌剂种类和含量的筛选以及抑菌剂稳定性的考察,并改进包装材料,以确保产品的安全有效。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 

分 类 号：R917[医药卫生—药物分析学] R978.1[医药卫生—药学]