他克莫司滴眼液的抑菌效力测定研究

Determination of Antimacrobial Effectiveness of Tacrolimus Eye Drops

目的:建立测定他克莫司滴眼液抑菌效力的方法。方法:参照中国药典2015年版抑菌效力检查法,以金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、白色念珠菌和黑曲霉为试验菌株,对他克莫司滴眼液样品进行菌落计数方法适用性试验。按验证的方法测定各时间点存活的菌数,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:他克莫司滴眼液中抑菌剂的抑菌效力能达到中国药典2015年版"A"的标准。结论:采用该方法可有效测定他克莫司滴眼液的抑菌效力。

Objective： To establish a method for the determination of antimacrobial effectiveness of tacrolimus eye drops. Methods： According to the requirements of antimacrobial effectiveness in 2015 edition of Chinese Pharmacopoeia （ ChP）, Staphylococcus au- reus, Pseudomonas aeruginosa, Escherichia coli, Aspergillus niger and Candida albicans were used as the test strains, and the suitabili- ty test for the colony count method was conducted for the samples of tacrolimus eye drops. The verified method was used to determine the number of viable bacteria at each time point, and then the bacteria number in 1 ml sample and the number of bacteria at each time point were calculated and converted to lg value. Results ： Tacrolimus eye drops could meet A standard for antimacrobial effectiveness in 2015 edition of ChP. Conclusion： The method can effectively determine antimacrobial effectiveness of tacrolimus eye drops.