左氧氟沙星滴眼液抑菌剂剂量筛选与抑菌效力研究

目的：探索左氧氟沙星滴眼液中抑菌剂的合理添加剂量。方法：根据药物成分的特性，对不同配比浓度抑菌剂的抑菌效果进行考察，筛选出适宜的供试品抑菌剂加入量。选择有代表性的挑战微生物加入供试品中进行挑战试验，测试微生物在不同时间段的存活情况。结果：0.004%~0.006%的苯扎氯铵对5种挑战微生物的生长有良好的抑制作用，且0.004%的苯扎氯铵为最低有效剂量。结论：0.004%~0.006%的苯扎氯铵可作为左氧氟沙星滴眼液的抑菌剂。

Objective: To determine the optimal concentration of the antimicrobial preservative added to levofloxacin eye drops by studying the antimicrobial effectiveness. Methods: According to the characteristics of ingredients,the antimicrobial effectiveness of the antimicrobial preservative was tested at different ratios to screen the appropriate adding dosage.Representative test microorganisms were selected to add into the test products to perform the challenge test so as to detect the survival status of microorganisms during different time periods. Results: The growth of test microorganisms was inhibited effectively by benzalkonium chloride ranging from 0.004% to 0.006%.Benzalko nium chloride of 0.004% was the minimal effective dosage. Conclusion: Benzalkonium chloride 0.004%~0.006% can be used as the antimicrobial preservative for levofloxacin eye drops.

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