重感灵片微生物限度检查及控制菌检查方法验证  

Methodlogy Validation Study of Microbial Limit Examination and Control Bacteria Examination of Zhongganling Tablets

作　　者：吴宗彬[1] 

机构地区：[1]广东省深圳市宝安区中医院,广东深圳518101

出　　处：《河北医学》2007年第7期831-834,共4页Hebei Medicine

摘　　要：目的:建立重感灵片的微生物限度检查方法,保证检验结果的正确性和可信性。方法:按中国药典方法进行菌回收率试验及控制菌检查方法验证。结果:5种试验回收率试验均达到70%以上,其中大肠埃希菌的回收率为84.2%、81.8%、90.4%;金黄色葡萄球菌的回收率为84.2%、81.8%、79.6%;枯草芽孢杆菌的回收率为92.6%、93.6%、87.4%;白色念珠菌的回收率为79%、75%、80.2%;黑曲霉菌的回收率为75%、81.2%、77%。控制菌测定中,大肠埃希菌及大肠菌群检查试验组均可检出试验菌,阴性组均无菌生长,阴性菌对照组均无生长。结论:本文所确立的方法可作为中成药制剂重感灵片的微生物限度检查方法学验证的依据。Objective： To establish a method of microbial limit examination of Zhongganling tablets,ensuring the validity and creditability of results.Method： According to the method of Chinese Pharmacopoeia,the bacteria recovery test and control bacteria examination were validated.Result： The recovery of Escherichia Coli,Staphylococcus aureus,Bacillus Sulticis,Candi-da albicans and Aspeigillus niger was in a range of 81.8%-90.4%,79.6%-84.2%,87.4%-92.6%,75%-80.2%,75%-81.2% respectively.All of them were higher than 70%.In the examination of control bacteria,both Escherichia Coli and Coliforms test groups were detected positive,and no bacteria was detected neither in negative groups nor in negative control groups.Conclusion： The method established can be used in microbial limit examination of Zhongganling tablets.

关 键 词：重感灵片 微生物限度 控制菌检查 

分 类 号：R286.0[医药卫生—中药学]