摘要
目的:建立测定地塞米松磷酸钠滴眼液抑菌效力的方法,评价其抑菌剂使用的合理性。方法:按照2015年版《中国药典》通则1121抑菌效力检查法项下要求,以金黄色葡萄球菌、铜绿假单胞杆菌、大肠埃希菌、白色念珠菌及黑曲霉为试验菌,对地塞米松磷酸钠滴眼液进行菌落计数适用性试验,然后进行微生物的挑战性试验,按方法学试验确定的不同时间点的测定存活菌数。结果:地塞米松磷酸钠滴眼液样品能达到"A"级抑菌效力标准。结论:本实验所用地塞米松磷酸钠滴眼液中的抑菌剂使用量为0. 02%硫柳汞和0. 38%硼砂,该浓度的抑菌剂对细菌和真菌均有较强抑菌作用,建议采用最低有效浓度,以确保产品安全、有效和稳定。
Objective: To establish a method for determining the bacteriostatic effect of dexamethasone sodium phosphate eye drops and to evaluate the rationality of its use. Methods: According to the requirements of the bacteriostatic efficacy test method of General Principles 1121 of the Chinese Pharmacopoeia of 2015 edition,the applicability of dexamethasone sodium phosphate eye drops was tested by using Staphylococcus aureus,Pseudomonas aeruginosa,Escherichia coli,Candida albicans and Aspergillus Niger as test bacteria,and then the challenge test of microorganisms was carried out. The number of viable bacteria was determined at different time points determined by methodological experiments. Results: Dexamethasone sodium phosphate eye drops can meet the " A" level bacteriostatic efficacy standard.Conclusion: The dosage of antimicrobial agent in dexamethasone sodium phosphate eye drops is 0. 02% thiomersal and 0. 38% borax.This concentration of antimicrobial agent has strong antimicrobial effect on bacteria and fungi. It is suggested that the lowest effective concentration be used to ensure the safety,effectiveness and stability of the product.
作者
王瑞荣
戴震
WANG Rui-rong;DAI Zhen(Nanjing Food and Drug Supervision and Inspection Institute,Jiangsu Nanjing 211100,China)
出处
《中国药物评价》
2019年第6期416-419,共4页
Chinese Journal of Drug Evaluation
关键词
地塞米松磷酸钠滴眼液
菌落计数
抑菌效力
Dexamethasone sodium phosphate eye drops
Colony count
Antibacterial effectiveness
