苄达赖氨酸滴眼液中抑菌剂的检测与评价

发布时间：2018-07-26 07:07

【摘要】：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。
[Abstract]:Objective: to evaluate the rationality of the use of benzalysine eye drops and to explore the rationality of two different 0-time definitions in the pharmacopoeia-loaded antimicrobial agents at home and abroad. Methods: six batches of representative experimental samples were selected according to the guidelines of Chinese Pharmacopoeia Antibacterial efficacy Test in 2010. Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus and Candida albicans were used. Five strains of Aspergillus Niger were used to test the antimicrobial activity of thiomersal, benzalkonium chloride and hydroxyethyl benzene, and the two different definitions at 0 time were compared. Results: according to the results of Chinese Pharmacopoeia, 2 out of 6 batches of samples were not in accordance with the regulations, the remaining 4 batches were in accordance with the regulations, but the decrease of bacterial count LG was much higher than the specified value of the pharmacopoeia, and for benzalysine eye drops, The results of statistical analysis showed that there was no significant difference in the results of two different 0-time definitions. Conclusion: the validity of 0-hour in the guidelines of Chinese Pharmacopoeia efficacy Test in 2010 remains to be further discussed. At present, the use of antimicrobial agents is not effective enough or the content of bacteriostatic agents is too high. It is necessary to pay attention to the selection of antimicrobial agents and the stability of antimicrobial agents in prescriptions in order to ensure the safety of drug use.
【作者单位】：浙江省食品药品检验研究院;
【基金】：浙江省药品接触材料质量控制研究重点实验室(计划编号:2014E10006)
【分类号】：R927.1

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