苄达赖氨酸滴眼液中抑菌剂的检测与评价

目的: 评价苄达赖氨酸滴眼液抑菌剂使用的合理性,并对国内外药典收载的抑菌剂效力检查法中2种不同0时定义的合理性进行探讨。方法: 选取6批有代表性的实验样品参照2010年版中国药典抑菌剂效力检查法指导原则,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、黑曲霉共5种试验菌株对硫柳汞、苯扎氯铵、羟苯乙酯3种抑菌剂成分进行抑菌剂效力测定,同时对2种不同0时定义进行了实验比较。结果: 按照中国药典结果判断的规定,6批样品中有2批抑菌剂效力不符合规定,其余4批虽符合规定,但菌数lg下降值远高于药典的规定值;对于苄达赖氨酸滴眼液,统计分析结果表明,2种不同0时定义的测定结果并无显著性差异。结论: 2010年版中国药典抑菌剂效力检查法指导原则中对0时的定义合理性有待进一步商榷。目前抑菌剂的使用存在抑菌效力不够或抑菌剂含量过高的现象,需重视处方中抑菌剂种类和含量的筛选以及抑菌剂稳定性的考察,以确保用药安全。

Objective: To evaluate the usage rationality of antimicrobial preservatives in domestic bendazac lysine eye drops and investigate the rationality of two different definitions of zero point(base point)of preservatives effectiveness test in domestic and international pharmacopoeia. Methods: The effectiveness of 3 kinds of antimicrobial preservatives was measured according to the guiding principles of preservative effectiveness test in ChP(2010 edition)by inoculating 5 kinds of test microorganisms including Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Candida albicans and Aspergillusniger.The two different definitions of zero points were compared by experiment. Results: According to the criteria of ChP for result judgment, 2 batches of antimicrobial preservatives in 6 batches of samples did not meet the requirements of effectiveness test.Although the other 4 batches of samples met the requirements, their log reductions were much higher than the qualifications in ChP.The statistical analysis indicated that the determination results for the two different definitions of zero point had no significant differences for bendazac lysine eye drops. Conclusion: Definition of zero point in the guiding principles of preservative effectiveness test in ChP(2010 edition)needs further discussion.There are problems existing in the usage of antimicrobial preservatives, such insufficient effectiveness and overdose of preservatives.It is necessary to pay attention to the screening of type and dosage of antimicrobial preservatives and the investigation on stability of preservatives so as to ensure drug safety.

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