盐酸米诺环素胶囊微生物限度检查方法的验证  

The Validation of Microbial Limit Tests of Minocycline Hydrochloride Capsules

作　　者：钱文静[1] 张玫[1] 

机构地区：[1]江苏省药品检验所,南京210008

出　　处：《中国药品标准》2008年第5期346-349,共4页Drug Standards of China

摘　　要：目的:建立盐酸米诺环素胶囊微生物限度检查方法。方法:取1∶500的低速离心供试液1 mL,稀释后进行薄膜过滤,用500 mL 45℃冲洗液分七次冲洗后贴膜,作为细菌数的检测。霉菌及酵母菌数测定,可用培养基稀释法每皿0.2 mL。控制菌检查,用低速离心加薄膜过滤法。结果:可以有效的去除盐酸米诺环素胶囊抗菌成分,使加菌回收达到满意的效果。结论:该方法准确、可靠。Objective：To establish a method for microbial limit test of Minocycline Hydrochloride Capsules. Method： 1 mL centrifugate was diluted with 500mL pH7. 0 buffer and filtrated by membrance and then the filter membrance was washed with 500 mL washing solution （45 ℃ ） for 7 times. The filter membrance can be tested for bacterial conoly counting. The culture medium dilution method can be used for fungus and yeasts counting. Low speed centrifugate and filter membrance method can be test for control bacterias. Result： The method can effectively eliminate the bacteriostasis effects of Minocyeline Hydrochloride Capsules and bacteria return ratio was satisfy. Conclusion：The method is reliable and accurate.

关 键 词：盐酸米诺环素 微生物限度 方法验证 低速离心 薄膜过滤 

分 类 号：R927.33[医药卫生—药学] R275.987.3