箭羽糖康片微生物限度检查的方法学验证研究  

Validation of tests for microbial limit count of jianyutangkang tablets

作　　者：白林[1] 郝爱真[2] 高翠萍[1] 

机构地区：[1]解放军总医院药检室,北京100853 [2]解放军总医院中医科,北京100853

出　　处：《中华医院感染学杂志》2012年第5期1099-1100,共2页Chinese Journal of Nosocomiology

摘　　要：目的建立箭羽糖康片的微生物限度检验方法。方法按《中国药典》2010年版规定,分别采用常规法、培养基稀释法对样品进行微生物限度检查,根据5株阳性对照菌的试验组、菌液组、供试品对照组的结果进行其方法学验证试验研究。结果箭羽糖康片具有抑菌活性,常规法枯草芽胞杆菌黑色变种芽胞的回收率为58.2%,培养基稀释法能有效去除其抑菌活性。结论用该法进行微生物限度检查,可以客观地反映药物中微生物的污染状况,以达到检测目的。OBJECTIVE To establish a method to determine the effectiveness of microbial limit viable count test of Jianyutangkang tablets.METHODS According to the Chinese Pharmacopoeia 2010 edition,routine method and medium dilution method were respectively performed for microbial limit test validation,two testing methods had different percentage of recovery with 5 control strains.RESULTS Jianyutangkang tablets had crude traditional Chinese medicine（TCM）,and had antimicrobial effects.The recovery rate of Bacillus subtilis was 58.2% using conventional method.Medium dilution method could effectively eliminate its bacteriostatic activity.CONCLUSION Both methods confirmed the effectiveness of microbial limit viable count test.

关 键 词：微生物限度检查 培养基稀释法 箭羽糖康片 

分 类 号：R446[医药卫生—诊断学]