不同滴眼液抑菌效力考察及使用中微生物污染情况评价

Investigation on bacteriostatic efficacy of different eye drops and evaluation microbial contamination in use

目的测定市售11个厂家的11种滴眼液的抑菌效力,并模拟患者日常使用过程,设计空气暴露实验,检测其受微生物污染情况。方法按照《中国药典》2015年版要求,判定11种滴眼液的抑菌效力。对污染微生物进行分离纯化培养,用全自动生化鉴定仪VITEK 2 Compact进行鉴定。结果18%的样品抑菌效力能达到A级;9%的样品抑菌效力能达到B级;73%的样品抑菌效力达不到B级。滴眼液在使用14 d后,有50%的样品开始受到微生物污染;使用28 d后,有70%的样品受到微生物污染,空气暴露试验分离得到4株条件致病菌。结论建议厂家合理使用及添加抑菌剂,改进商品包装,减少滴眼液在使用中被微生物污染的风险。

Objective To evaluate the bacteriostatic efficacy of eleven kinds of eye drops from different manufacturers available in market,and to detect microbial contamination by air exposure experiment which simulated eye drops in daily use.Methods The bacteriostatic efficacy of eleven kinds of eye drops was detected following Chinese Pharmacopoeia 2015.The contamination microorganisms were isolated,cultured and biochemically identified by VITEK 2 Compact.Results 18%samples could reach level A of bacteriostatic efficacy,9%samples were at level B,and 73%samples could not comply with level B.The half of and 70%samples were contaminated by microbe after opening for 14 and 28 days respectively.The four conditioned pathogens were collected by air exposure experiment.Conclusion It is recommend that manufacturers should reasonably use of bacteriostatic agent and improve packaging to avoid risk of microbial contamination in use.