一次性氧氟沙星滴眼液抑菌效力的检测及其结果评价

目的：探讨2种市售一次性氧氟沙星滴眼液对细菌及霉菌的抑菌效力，阐明
未添加防腐剂的一次性氧氟沙星滴眼液仍具备合适的抑菌效力。方法：采用《中国药典》20
10版（二部）抑菌效力检查法指导原则，测定2种一次性氧氟沙星滴眼液对金黄色葡萄球菌
［CMCC（B）26003］、大肠埃希菌［CMCC（B）44102］和铜绿假单胞菌［CMCC（B）10104］的最小抑
菌浓度(MIC)，采用菌落计数法记录药品对白假丝酵母菌［CMCC（F）98001］及黑曲霉菌［CMCC（F
）98003］作用不同时间（0、7、14和28 d）后的活菌数。以非一次性氧氟沙星滴眼液作为
阳性对照组。结果：2种一次性氧氟沙星滴眼液对黑曲霉菌作用7、14和28 d后，黑曲霉
菌数未见增加，白假丝酵母菌生长基本被抑制；2种一次性氧氟沙星滴眼液对金黄色葡萄球
菌、大肠埃希菌和铜绿假单胞菌均有明显的抑制作用，且MIC值均为5.9 mg?L-1。一次性氧氟沙星滴眼液与非
一次性氧氟沙星滴眼液抑菌效力相同。结论：随机选购的市售2种一次性氧氟
沙星滴眼液的抑菌效力符合《中国药典》2010版（二部）抑菌效力检查法指导原则中对标准
眼用制剂的要求，不添加抑菌剂的抗生素类滴眼液亦具备合适的抑菌效力。
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Detection of bacteriostatic effect and evaluation of disposable ofloxacin eye drops

Objective To investigate the antimicrobial effects of disposable ofloxacin eye drops chosen randomly from the market on the bacteria and fungus,and to expound that the eye drops without preservatives still have the proper bacteriostatic effect.Methods The minimum inhibitory concentration(MIC)of Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa were determined by broth microdilution method specified in Chinese Phrmcopoei.The bacterial colony of Candida albicans and Aspergillus niger in different time points(0,7,14 and 28d)after treated by ofloxacin were recorded.Non-disposable ofloxacin eye drops was used as positive control group.Results 7,14,28dafter treatment of disposable ofloxacin eye drops,the fungus number of Aspergillus was not increased and the growth of Candida albicans was almost inhibited.The disposable ofloxacin eye drops also had significantly inhibitory effect on Staphylococcus aureus,Escherichia coli and Pseudomonas aeruginosa,and the MIC was 5.9mg·L-1.The antimicrobial efficacy of disposable ofloxacin eye drops was similar to that of nondisposable ofloxacin eye drops.Conclusion The antimicrobial effect of disposable Ofloxacin eye drops selected from the market all meet the requirements of ophthalmic preparations in Chinese Pharmacopeia.The bacteriostatic agent without preservatives also has proper bacteriostatic effect.