商业定量菌株用于药品微生物计数法建立的可行性探讨  

Discussion on the feasibility of commercial quantitative strains used in the establishment of microbial count method of drugs

作　　者：李趣嫦[1] 张帆[1] 李文靖[1] 江艳芳 LI Qu-chang;ZHANG Fan;LI Wen-jing;JIANG Yan-fang(Guangdong Institute for Drug Control,Guangzhou 510663,China)

机构地区：[1]广东省药品检验所,广州510663

出　　处：《药物分析杂志》2020年第11期2093-2097,共5页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:探索4家商业定量菌株(金黄色葡萄球菌、枯草芽孢杆菌、铜绿假单胞菌、白色念珠菌和黑曲霉)用于建立药品微生物限度检查计数方法的适用性。方法:选取6种具有代表性的非无菌制剂作为样品,用工作菌株的新鲜培养物按照《中华人民共和国药典》(简称《中国药典》)2015年版微生物限度检查法进行计数方法建立,然后按照建立的方法用4个不同厂家的商业定量菌株作回收值比较。结果:与工作菌株新鲜培养物比较,商业定量菌株中的枯草芽孢杆菌、铜绿假单胞菌、白色念珠菌和黑曲霉,这4种菌株中部分回收比值偏低,甚者不能达到0.5,而金黄色葡萄球菌则无明显区别。结论:商业定量菌株用于含抑菌成分的药品微生物计数法方法的建立时,应对其进行质量考察和风险评估。Objective:To explore the applicability of four commercial quantitative strains including Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans and Aspergillus niger for microbial limit test and counting of drugs.Methods:The microbial limit test method was established and validated according to Chinese Pharmacopoeia 2015 by using fresh culture of laboratory strains and selecting six representative non sterile preparations as samples.Then,the established method was applied to test the commercial quantitative strains from four different factories,and the obtained recoveries were used for comparison.Results:Compared with fresh working strains,the recoveries of Bacillus subtilis,Pseudomonas aeruginosa,Candida albicans,and Aspergillus Niger in partial commercial quantitative strains were relatively low,and even lower than 0.5.However,there was no significant difference for Staphylococcus aureus.Conclusion:The quality investigation and risk assessment should be carried out in the establishment of microbial counting method for drugs containing bacteriostatic components using commercial quantitative strains.

关 键 词：定量菌株 新鲜培养物 药品微生物计数法 方法适用性 回收比值 

分 类 号：R917[医药卫生—药物分析学]