维生素B_(12)滴眼液尼泊金乙酯的抑菌效力研究

Studies on antimicrobial efficacy of Vitamin B_(12) Eye Drops

目的探索维生素B_(12)滴眼液中抑菌剂的合理添加剂量,按《中国药典》2015年版抑菌效力检查法测定维生素B_(12)滴眼液的抑菌效力。方法根据药物成分的特征,选择合适的抑菌剂,对不同浓度抑菌剂的抑菌效果进行考察,筛选出抑菌剂的合理添加量,采用《中国药典》要求的试验菌株进行检查,然后对含不同浓度的羟苯乙酯维生素B_(12)滴眼液进行检查,测定各个时间点的菌落数。结果按照《中国药典》2015年版检验,分别对含0.15%、0.10%、0.07%、0.05%和0.03%羟苯乙酯的维生素B_(12)滴眼液进行金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、白色念珠菌和黑曲霉5种试验菌的抑菌性检查,0.03%羟苯乙酯对金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌抑菌性不符合规定,0.05%羟苯乙酯检查铜绿假单胞菌、大肠埃希菌抑菌性在最低检测线上,符合规定,最终选定0.07%羟苯乙酯为最佳抑菌浓度。结论 0.07%的羟苯乙酯可作为维生素B_(12)滴眼液的抑菌剂。

Objective To explore the reasonable dosage of the antibacterial agent in Vitamin B_（12） Eye Drops.and to determine the antimicrobial efficacy of Vitamin B_（12） Eye Drops according to the Chinese Pharmacopoeia 2015 edition.Methods According to characteristic of drug ingredients,choosing appropriate antimicrobial agents,the antibacterial effect of different concentrations of antibacterial agents were investigated and selection of reasonable dosage of antibacterial agent,the test strains in Chinese Pharmacopoeia requirements for inspection were adopted,then Vitamin B_（12） Eye Drops containing different concentrations of ethylparaben were checked,and the bacterial colonies at different time points were determined.Results According to Chinese Pharmacopoeia 2015 edition,the antimicrobial test of Vitamin B_（12） Eye Drops containing 0. 15%,0.10%,0.07%,0.05% and 0. 03% of ethylparaben,respectively,for Staphyococcus aureus,Pseudomonas aeruginosa,Escherichia coli,Candia albicans and Aspergillus niger were checked. The antimicrobial efficacy of 0. 03% ethylparaben to Staphyococcus aureus,Pseudomonas aeruginosa,Escherichia coli did not meet the requirements,the antibacterial activity of0. 05% ethylparaben to Pseudomonas aeruginosa,Escherichia coli was on the lowest detection line.The best antibacterial concentration of ethylparaben was 0.07%.Conclusion 0.07% ethylparaben can be used as antibacterial agent for Vitamin B_（12） Eye Drops.