添加季铵盐类防腐剂的加替沙星滴眼液抑菌效力的检测与评价

摘要

OBJECTIVE Evaluation of the rationale on antimicrobial quaternary ammoni um salt addition to gatifloxacin.METHODS The eye drops products containing antimicrobial Benzalkon ium chloride and Benzyl bromide were selected.On the basis of antibacterial test 1121 in Ch inese Pharmacopoeia 2015 Volume I,Pseudomonas aeruginosa,Escherichia coli,Pseu domonas aeruginosa,Candida albican,and Aspergillus niger were used to evaluate the effect of eye drops with and without these two antimicrobial additives.RESULTS According to the criteria in ChP2015,for the selected three batches of sa mples,the ones containing antimicrobial additives reached the criteria of bacte rial inhibition"A".The ones without additives failed to meet neither the crit eria of bacterial inhibition "A" nor "B".CONCLUSION Both 0.005% Benzalkoni um chloride and 0.01% Benzyl bromidecan be used as quaternary ammonium salt add itives for gatifloxacin.The eye drops without antimicrobial additives should co ntain a proper amount of antimicrobial substance which demonstrates the minimal dose of antibacterial effect.%目的 对添加季铵盐类防腐剂的加替沙星滴眼液抑菌效力进行检测和评价.方法 选取添加含苯扎氯铵和苯扎溴铵防腐剂的加替沙星滴眼液,并按照中国药典2015版(ChP2015)四部通则1121抑菌效力检查法,采用铜绿假单胞菌、大肠埃希菌、金黄色葡萄球菌、白色念珠菌、黑曲霉5种菌株,对添加以及不添加两种防腐剂的滴眼液进行了效力测定.结果 根据中国药典2015版标准规定,选取的3批样品中,添加防腐剂的加替沙星滴眼液达到抑菌效力标准的液"A",或至少达到抑菌效力"B";未添加防腐剂的加替沙星滴眼液未能达到抑菌效力标准"B".结论 0.005%苯扎氯铵和0.01%苯扎溴铵皆可作为加替沙星滴眼液的季铵盐类防腐剂;不含防腐剂的滴眼液中,应适当添加抑菌效力测试测得最低剂量的防腐剂.