氧氟沙星滴眼液的抑菌效力测定

Determination of Antibacterial Effect of Ofloxacin Eye Drop

目的:建立测定氧氟沙星滴眼液抑菌效力的方法。方法:按照2015年版《中国药典》"抑菌效力检查法"项下要求,以金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、黑曲霉和白色念珠菌为试验菌,对氧氟沙星滴眼液样品进行菌落计数方法适用性试验,并按该试验确定的方法测定不同时间点的存活菌数,计算1 mL供试品中各试验菌所加的菌数及各间隔时间的菌数,并换算成lg值。结果:氧氟沙星滴眼液样品能达到"B"的抑菌效力标准。结论:采用该方法可有效判定氧氟沙星滴眼液的抑菌效力是否达标。

OBJECTIVE：To establish a method for the determination of antibacterial effect of Ofloxacin eye drop. METHODS：According to the requirements in Chinese Pharmacopoeia（2015 edition）＂antibacterial effect test＂,using Staphylococcus aureus,Pseudomonas aeruginosa,Escherichia coli,Aspergillus niger and Candida albicans as test bacteria,colonycount method suitability test was conducted for Ofloxacin eye drop samples,the verified method was used to determine the number of viable bacteria at each time point,calculate the bacteria number of 1 m L in the sample and the number of bacteria at each time point and convert to lg value. RESULTS：Ofloxacin eye drop sample can reach the standard of antibacterial effectiveness of the＂B＂. CONCLUSIONS：The method can effectively determine whether the antibacterial effect of Ofloxacin eye drop fits the standard.