口服药品控制菌标准的研究  

The Study of Standard of Oral Drug Control Bacteria

作　　者：陈金荣[1] 刘晓玲[1] 房榕[1] 

机构地区：[1]福建省药品检验所,福州350001

出　　处：《海峡药学》2002年第2期29-31,共3页Strait Pharmaceutical Journal

摘　　要：目的　为了探讨如何合理制订口服药品控制菌标准。 方法 　以大肠菌群和大肠杆菌分别作为口服药品卫生指标菌 ,按 2 0 0 0年版《中国药典》和国标《食品卫生检验方法》对 139批中成药进行检验。结果 　以大肠菌群为卫生指标菌的检出率远高于大肠杆菌 ,并经卡方 (χ2 )检验。结论 　证明用大肠菌群作为口服药品控制菌标准较为合理 。OBJECTIVE to establish the standard of oral drug control bacteria.METHODS We use Coli-group and Escherichia Coli as the standard of oral drug control bacteria.The 139 batch Chinese traditional patent medicines are tested by Chinese pharmacopoeia in 2000 years and food health test method of national standard.RESULTS The rates of test of Coli-group are more high than Escherichia coli.CONCLUSION By the Chi-square(χ 2)test,it is more reasonable as well as more high, for the quality of the drug health,that the Coli-group used as control bacteria standard.

关 键 词：大肠杆菌 大肠菌群 口服药品 控制菌标准 药品卫生质量 

分 类 号：R927.11[医药卫生—药学]