心悦片微生物限度检查的方法学验证研究  

Xinyue tablets for validation methods used for microbial limit test

作　　者：白林[1] 刘屏[2] 高翠萍[1] 

机构地区：[1]解放军总医院药检室,北京100853 [2]解放军总医院药理研究室,北京100853

出　　处：《中华医院感染学杂志》2011年第21期4632-4633,共2页Chinese Journal of Nosocomiology

摘　　要：目的建立心悦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、供试品对照组结果进行方法学验证试验。结果金黄色葡萄球菌、大肠埃希菌、白色假丝酵母菌、黑曲霉菌采用常规法回收率均>70.0%,枯草芽胞杆菌黑色变种芽胞采用培养基稀释法回收率>70.0%,心悦片具有抑菌活性,培养基稀释法能有效地去除其抑菌活性。结论用培养基稀释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 the Xinyue tablets method and determine the microbial limit. METHODS According to the Chinese Pharmacopoeia 2010 edition, microbial limit tests were performed to the samples by respectively using the routine method and medium dilution method. The experimental validation methods were studied through comparing the results of 5 positive control strains in experimental group,bacilli group and Xinyue tablets group. RESULTS The recovery rates of Staphylococcus aureus, Escherichia coli Candida albicansand Aspergillus niger validated by the routine method were all above 70%. The recovery rates of Black variant of Bacillus subtilis spores validated by medium dilution method was above 70%. Xinyue tablets had antimicrobial activity, and the antimicrobial activity could be effectively eliminated by employing the medium dilution method. CONCLUSION The medium dilution method applied in microbial limit test can objectively reflect the condition of microbial contamination in antibiotics, so as to achieve the testing purpose.

关 键 词：微生物限度检查 培养基稀释法 心悦片 

分 类 号：R446.1[医药卫生—诊断学]