双氯灭痛乳胶剂微生物限度检查的方法学验证研究  

Validation method used for microbial limit test of diclofenac latex agent

作　　者：白林[1] 高翠萍[1] 

机构地区：[1]解放军总医院药检室,北京100853

出　　处：《中华医院感染学杂志》2012年第1期216-217,共2页Chinese Journal of Nosocomiology

摘　　要：目的建立双氯灭痛乳胶剂的微生物限度检验方法。方法按《中国药典》2010年版规定,分别采用培养基稀释法、薄膜过滤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。结果双氯灭痛乳胶剂具有抑菌活性,培养基稀释法回收率<70.0%,薄膜过滤法能有效的去除其抑菌活性。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 the method to determine the microbial limit viable count test of diclofenac tatex agent. METHODS According to the Chinese Pharmacopoeia 2010 edition, two testing methods had different percentages of recovery with 5 control strains, and the methodology validation was performed by referring 5 positive control strains. RESULTS Diclofenac latex agent had antimicrobial effects, The recovery rate of medium dilution method was less than 70.0%, which could be eliminated by membrane filtration method. CONCLUSION This method can achieve the destination is feasible and accurate.

关 键 词：微生物限度检查 薄膜过滤法 双氯灭痛乳胶剂 

分 类 号：R446[医药卫生—诊断学]