市售氯霉素滴眼液的抑菌效力评价  

Bacteriostatic Efficacy Evaluation of Chloramphenicol Eye Drops

作　　者：林玉双 刘晓玲 吴燕燕 高丹玲 廖燕萍 LIN Yushuang;LIU Xiaoling;WU Yanyan;GAO Danling;LIAO Yanping(Fujian Institute for Food and Drug Quality Control,Fujian Fuzhou 350001,China)

机构地区：[1]福建省食品药品质量检验研究院,福建福州350001

出　　处：《中国医药导刊》2024年第2期143-148,共6页Chinese Journal of Medicinal Guide

摘　　要：目的:评价市售氯霉素滴眼液的抑菌效力。方法:按照《中华人民共和国药典》2020年版四部通则1121抑菌效力检查法,选取金黄色葡萄球菌、铜绿假单胞菌、白色念珠菌和黑曲霉为试验菌,对来自8家企业的氯霉素滴眼液进行评价。结果:添加0.02 mg·mL^(-1)醋酸苯汞的氯霉素滴眼液抑菌效力符合A标准。添加0.5 mg·mL^(-1)羟苯乙酯的氯霉素滴眼液抑菌效力符合B标准。添加0.03 mg·mL^(-1)苯扎溴铵或0.25~0.3 mg·mL^(-1)羟苯乙酯的氯霉素滴眼液,存在对细菌的抑菌效力达不到B标准的情况。结论:部分氯霉素滴眼液中抑菌剂种类或浓度不适宜,需进一步完善配方,以提高其安全性。Objective:To evaluate the bacteriostatic efficacy of chloramphenicol eyes drops available on market.Methods:According to the 1121 bacteriostatic efficacy test method in Chinese Pharmacopoeia(2020 edition)volume IV general requirements,test strains including Staphyococcus aureus,Pseudomonas aeruginosa,Candia albicans and Aspergillus niger were selected to assess chloramphenicol eye drops from eight different companies.Results:The test results showed that chloramphenicol eye drops with the addition of 0.02 mg·mL^(-1) phenylmercuric acetate met the A standard for bacteriostatic efficacy,while those with the addition of 0.5 mg·mL^(-1) ethyl hydroxy-benzoate met the B standard for bacteriostatic efficacy.Some chloramphenicol eye drops with the addition of 0.03 mg·mL^(-1) benzalkonium bromide or 0.25-0.3 mg·mL^(-1) ethyl hydroxybenzoate did not meet the B standard for bacteriostatic efficacy.Conclusion:This evalua-tion identified inappropriate types or concentrations of bacteriostatic agents in some chloramphenicol eye drops.Therefore,further improvement of the formulation is needed to improve the safety of chloramphenicol eye drops.

关 键 词：氯霉素滴眼液 抑菌效力 醋酸苯汞 羟苯乙酯 

分 类 号：R927.32[医药卫生—药学]