脑心通片微生物限度检查细菌计数方法的研究  

Study on Bacterial Colony Counting Method in Microbial Limit Test of Naoxintong Tablets

作　　者：郑力真 国明 丁勃 

机构地区：[1]山东省药品检验所,济南250012

出　　处：《中国药品标准》2007年第3期23-25,共3页Drug Standards of China

摘　　要：目的:对有特殊抑菌情况的品种脑心通片建立适合的细菌计数方法。方法:采用测定菌回收率的方法,在2005年版药典规定的三种方法验证用细菌的基础上增加一种从样品中污染的细菌中分离纯化得到的菌株Z1进行脑心通片的细菌计数方法学验证。结果:用常规法对脑心通片细菌计数方法进行验证,2005年版药典规定的各试验菌回收率可达到70%以上,但微生物检查结果仍显示样品具有抑菌作用,且Z1的回收率达不到70%。改用培养基稀释法后,2005年版药典规定的各试验菌及Z1的回收率均达到70%以上,微生物检查结果正常。结论:单纯用药典规定的三种细菌试验菌对某些药品进行细菌计数方法验证不具有完全代表性,菌落计数方法验证应该是动态的研究过程。本试验确定的细菌计数方法能有效地消除脑心通片对各种细菌的抑菌作用,充分反映样品被污染情况。Objective ： To establish a suitable bacterial colony counting method for the microbial limit test of Naoxintong Tablets with Special bacteriostasis characteristic. Method：Add a bacterium Z1, which is separated from bacteria contaminated in Naoxintong Tablets,to detect the bacteria return ratio by using ChP 2005 method. Results：The return ratio of all the three kinds of experimental bacteria in ChP 2005 are above 70% but the return ratio of Z1 is under 70% by normol method. However,the return ratio of Z1 can achieve 70% if the culture medium dilution method is used. Conclusion：For some kinds of medicines,it＇s not complete to verify bacteria Colony-counting method with the three kinds of bacteria stipulated in ChP 2005 only. Verifying the bacterial Colony counting method involves in a dynamic process. The study has developed a bacterial Colony counting method which can effectively eliminate the bacteriostasis effect resulting from the Naoxintong Tablets. In this way the extent to which the medicine has been polluted by the bacteria can be adequetely measured.

关 键 词：脑心通片 微生物限度 细菌计数 

分 类 号：R927.1[医药卫生—药学]