七叶神安片微生物限度检查方法验证试验的探索  

Investigation of Qi YeShen' An Tablet for Microbial Limit Validation Methods

作　　者：郑丽莉[1] 林辉煌[1] 吴晓玲[1] 

机构地区：[1]福建省药品检验所,福州350001

出　　处：《海峡药学》2006年第6期42-44,共3页Strait Pharmaceutical Journal

摘　　要：目的建立一种可行的检验方法,提高药品污染微生物的检出率,保证其检验结果的准确性和有效性〔1〕。方法采用药典规定的常规法和其它可以消除供试品抑菌作用的方法对七叶神安片进行5种菌株的回收率实验。结果采用常规法5株菌种中只有大肠埃希杆菌和白色念珠菌的回收率大于70%,金黄色葡萄球菌、枯草芽孢杆菌和黑曲霉的回收率均低于70%,培养基稀释法(0.2ml/皿)黑曲霉和枯草芽孢杆菌的回收率大于70%,培养基稀释法(0.2ml/皿)和离心集菌培养基稀释法(0.2ml/皿)对金黄色葡萄球菌的回收率仍低于70%,采用离心薄膜过滤法,金黄色葡萄球菌的回收率可超过70%。结论七叶神安片的细菌计数方法可采用离心薄膜过滤法,霉菌及酵母菌计数方法可采用培养基稀释法(0.2ml/皿)。OBJECTIVE To establish a doable validation method to improve the detectable rate of Qiyeshen＇ an tablet polluted microbial,assure the creditability. METHODS The validation have been tested by the ratio of recovery of five germs from Qiyeshen＇ and tablet with the and any other methods. RESULTS Use The general method, only the Escherichia coil anti Candida albicans＇returns-ratio are bigger than 70%, but the Stabphy iococcus aureus and the Bacillus and the Aspergillus niger＇s returns-ratio are lower than 70%, use the culture medium dilution （the 0. 2ml · d/ish）,the Aspergillus niger and the Bacillus subtilis＇ returns-ratio are bigger than 70%, the culture medium dilution （the 0. 2ml/dish） and the centrifugal collection fungus culture medium dilution （the 0. 2ml/dish） still is lower than 70% to the Staphylococcus aureus＇ returns-ratio, use the membrane filtration, the returns-ratio might surpass 70% in the end. CONCLUSION The Bacterium counts can use membrane filtration with dilution ;the mold counts can use dilution （the 0.2ml/dish）.

关 键 词：方法学验证 七叶神安片 菌种 回收率 

分 类 号：R91[医药卫生—药学] K927.12[历史地理—人文地理学]