FTIR法用于药品检出菌与药品微生物检验洁净室环境菌的相关性考察

被引：23

作者：

裴琳 ^{[1
]}

胡昌勤 ^{[1
]}

马仕洪 ^{[1
]}

戴翚 ^{[1
]}

杭太俊 ^{[2
]}

机构：

[1] 中国药品生物制品检定所

[2] 中国药科大学

来源：

药学学报 | 2007年 / 11期

关键词：

FTIR; 药品无菌检查; 微生物控制; 洁净室; 相关性;

D O I：

10.16438/j.0513-4870.2007.11.015

中图分类号：

R927 [药物鉴定];

学科分类号：

摘要：

应用FTIR法对药品检出菌与微生物检验洁净室环境菌进行相关性考察,通过临界匹配值法和聚类分析法比较药品检出菌与环境菌FTIR图谱的相似性;构建了洁净室环境菌的FTIR光谱谱库,确定了快速判断药品检出菌是否为环境菌污染的指标,为药品无菌检查一次性报告的准确性提供了保证,并可以实现对洁净室环境微生物的动态监控;方法简便、准确、快捷,易于在药品微生物控制中推广。

引用

页码：1189 / 1194

页数：6

共 8 条

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