摘要
目的:建立氯雷他定糖浆剂抑菌效力检查方法,并评价厂家提供的三批药品的抑菌效力情况。方法:依据《中国药典》2020年版四部(通则1121),以金黄色葡萄球菌、铜绿假单胞菌、大肠埃希菌、白色念珠菌和黑曲霉为试验菌株,确定氯雷他定糖浆剂的菌落计数方法,并按该方法测定不同时间点的存活菌落数,并把菌落数换算成lg值,进而建立该样品的抑菌效力检查法。结果:通过测定第14天、28天细菌和真菌下降的lg值,三批药品均通过抑菌挑战试验。结论:该法可用于氯雷他定糖浆剂的抑菌效力测定,但抑菌剂的合理添加量需要进一步研究优化。
Objective:To establish a method for the antibacterial effect of loratadine syrup.And to evaluatethe antibacterial effect of 3 batches of loratadine syrup from the manufacturer.Methods:According to the general rule 1121 of the fourth part of CH.P(2020),using staphylococcus aureus,pseudomonas aeruginosa,escherichia coli,candida albicans and aspergillus niger as test strains,the colony counting method of loratadine syrup was conducted,and the number of viable colonies at different time points was determined according to the method,and was converted to lg value.Then the bacteriostatic efficacy test method of the sample was established.Results:By measuring the decreased lg values of bacteria and fungus on the 14th day and the 28th day,the 3 batches of loratadine syrup passed the antimicrobial effectiveness challenge test.Conclusion:This established method can be applicable to the antibacterial effect test of loratadine syrup.But the reasonable dosage of antimicrobial preservatives needs to be optimized.
作者
吕杨兰
LYU Yanglan(Sanming Inspection and Testing Center,Sanming Fujian 365000,China)
出处
《药品评价》
CAS
2022年第10期589-591,共3页
Drug Evaluation
关键词
苯甲酸钠
氯雷他定糖浆剂
抑菌剂
抑菌效力
评价
Sodium benzoate
Loratadine syrup
Antimicrobial preservatives
Antimicrobial effectiveness
Evaluation
