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作 者:王蕴红 谢文麟 梁雪 Wang Yunhong;Xie Wenlin;Liang Xue(Quality Control Department,Chengdu Rongsheng Pharmaceuticals Co.,Ltd.,Chengdu 610041,China)
机构地区:[1]成都蓉生药业有限责任公司质量检定部,610041
出 处:《国际生物制品学杂志》2021年第2期93-96,共4页International Journal of Biologicals
摘 要:目的探讨采用复苏等量分装的标准贮备菌株培养18~24 h后配制的菌悬液作为生物制品微生物验证用菌液的可行性。方法制备等量分装的标准贮备菌株,选择保藏0、3、6、9、12、13个月对其复苏后菌液进行菌落计数,对计数结果进行单因素方差分析。结果分析显示,储存3、6、9、12、13个月的金黄色葡萄球菌、大肠埃希菌、铜绿假单胞菌、白色念珠菌计数与0个月比较无显著差异,F值分别为2.24、2.21、0.58、1.59,P值均大于0.05,计数结果稳定。结论采用等量分装的标准贮备菌株复苏后配制菌悬液,可作为生物制品微生物验证用菌液,菌液浓度稳定。Objective To evaluate the feasibility of preparing bacterium suspension by recovering the standard bacterium in equal volume and culturing 18-24 h for microbial verification.Methods Standard bacteria were prepared in equal volume.Then the recovered strains were counted after storing for 0,3,6,9,12,13 months.The colony counting results were analyzed by single-factor analysis of variance.Results Compared with 0 month,the counts of Staphylococcus aureus,Escherichia coli,Pseudomonas aeruginosa and Candida albicans after storing for 3,6,9,12,13 months were stable and of no statistically significant difference,with F values of 2.24,2.21,0.58 and 1.59,respectively,and all P values>0.05.Conclusion Using recovered standard bacterium in equal volume to prepare the bacterium suspension for microbial verification of biological products is feasible,and with bacterium concentration stable.
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