目的:探讨氟康唑滴眼液中抑菌剂的合理添加剂量.方法:按照中国药典2015年版抑菌剂效力检查法,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,对分别含4个不同浓度抑菌剂(5%,1%,0.3%,0.1%苯扎氯铵)的氟康唑滴眼液进行抑菌剂效力测定.结果:含5%,1%,0.3%苯扎氯铵的氟康唑滴眼液对金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、白色念珠菌和黑曲霉5种试验菌的抑菌效力均符合规定,0.1%苯扎氯铵对铜绿假单胞菌抑菌效力不符合规定,0.3%为苯扎氯铵的最低抑菌浓度.结论:确定苯扎氯铵的最佳抑菌浓度为1%.%Objective:To explore the reasonable amount of bacteriostatis agent in fluconazole eye drop. Methods: According to the method of bacteriostatis effect test in 2015 edition of Chinese Pharmacopoeia (ChP), and Staphyococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Candia albicans and Aspergillus niger as the test strains, the bacteriostatis effect of fluconazole eye drop containing 5%, 1%, 0. 3% and 0. 1% benzalkonium chloride was determined. Results: The bacteriostatis effects of fluconazole eye drop containing 5%, 1% and 0. 3% benzalkonium chloride on the five species of tested bacteria complied with the regulations of ChP. The bacteriostatis effects of 0. 1% benzalkonium chloride on Pseudomonas aeruginosa didn't meet the requirements, therefore, 0. 3%was the minimum inhibitory concentration ( MIC) of benzalkonium chloride. Conclusion: The best inhibitory concentration of benza-lkonium chloride is 1%.
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