环氧乙烷灭菌生物指示剂D值测定方法研究  

Study on the Test Method of D Value of Ethylene Oxide Detergent Biological Indicator

作　　者：曹炜 沈泓 李珏 吴鑫 梁法勇 李超 孙晗 

机构地区：[1]浙江省食品药品检验研究院,杭州310052

出　　处：《中国现代应用药学》2017年第12期1672-1674,共3页Chinese Journal of Modern Applied Pharmacy

基　　金：2014年国家药典委员会标准提高研究项目;浙江省药品接触材料质量控制研究重点实验室(2014E10006)

摘　　要：目的研究环氧乙烷灭菌指示剂D值测定方法。方法采用部分阴性法测定不同厂家产品的D值,用存活灭杀时间进行验证,两者一致说明部分阴性法测定D值结果有效。若无法验证,则采用残存曲线法重新测定D值,再进行验证。结果 5个样本中,3个用部分阴性法测定的D值可以被存活灭杀时间验证。另2个样本用残存曲线法测定的D值与验证结果一致。结论 D值是评价环氧乙烷灭菌生物指示剂产品质量的关键性技术参数,部分阴性法和残存曲线法的D值测定结果存在差异,为确证D值测定结果的准确性,应采用存活灭杀时间对测定结果进行验证。OBJECTIVE To research the test method for D value determination of ethylene oxide sterilization indicator. METHODS The D value of products from different companies were determined by limited Sperman-Karber （LSKP） method and proved by survival and killing time. The consistency of these two results indicated the validity of D value. If D value couldn＇t be proved by LSKP method, survival-curve method should be selected to examine D value. RESULTS Among the D value of the 5 samples, three of them using LSKP method could be validated by survival and killing time. The results of other two samples examined by survival-curve method were validated by survival and killing time successfully. CONCLUSION D value is the key technical parameter to evaluate the product quality of ethylene oxide sterilization biological indicator. The results olD value examined by LSKP method and survival-curve method show the difference. Survival and killing time is recommended to be applied in validation to assure the accuracy of D value.

关 键 词：环氧乙烷 生物指示剂 D值 

分 类 号：R945[医药卫生—微生物与生化药学]