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当归腹宁滴丸微生物限度检查法的建立
引用本文:郭朝晖,何晓英,欧阳晓玫.当归腹宁滴丸微生物限度检查法的建立[J].中国药房,2009(3):213-214.
作者姓名:郭朝晖  何晓英  欧阳晓玫
作者单位:甘肃省药品检验所,兰州市730000
摘    要:目的:建立当归腹宁滴丸微生物限度检查法。方法:测定当归腹宁滴丸对5种验证菌株的回收率,并对控制菌的检查法进行验证。结果:当归腹宁滴丸对金黄色葡萄球菌、枯草芽孢杆菌有较强的抑制作用,对大肠埃希菌、白色念珠菌、黑曲霉菌无抑制作用。结论:采用薄膜过滤法可消除当归腹宁滴丸在试验条件下的抑菌作用,并进行菌数计数检验;采用常规法即可进行控制菌检查。

关 键 词:当归腹宁滴丸  微生物限度检查法  方法验证

Establishment of Microbial Limit Test for Danggui Funing Drop Pills
Institution:GUO Zhao-hui,HE Xiao-ying,OUYANG Xiao-mei(Gansu Institute of Drug Control, Lanzhou 730000, China)
Abstract:OBJECTIVE: To establish the Microbial limit test(MLT) for Danggui funing drop pills.METHODS: The recovery rates of 5 tested strains treated by Danggui funing drop pills were detected and the MLT method for the control bacteria was validated.RESULTS: Danggui funing drop pills exhibited strong inhibitory effect on staphylococcus aureus and bacillus subtilis,but showed no effect on escheriehia coli, candida albicans and aspergillus niger. CONCLUSION: By membrane-filter procedure, the antibacterial effect of Danggui funing drop pills can be eliminated and the bacterial count can be conducted; however, by routine method, the test of control bacteria is feasible.
Keywords:Danggui funing drop pills  Microbial limit test  Method validation
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