| 引用本文: | 曹炜,沈泓,李珏,吴鑫,梁法勇,李超,孙晗.环氧乙烷灭菌生物指示剂D值测定方法研究[J].中国现代应用药学,2017,34(12):1672-1674. |
| CAO Wei,SHEN Hong,LI Jue,WU Xin,LIANG Fayong,LI Chao,SUN Han.Study on the Test Method of D Value of Ethylene Oxide Detergent Biological Indicator[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(12):1672-1674. |
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| 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。 |
| 关键词: 环氧乙烷 生物指示剂 D值 |
| DOI：10.13748/j.cnki.issn1007-7693.2017.12.006 |
| 分类号:R945 |
| 基金项目: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） |
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| Study on the Test Method of D Value of Ethylene Oxide Detergent Biological Indicator |
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CAO Wei, SHEN Hong, LI Jue, WU Xin, LIANG Fayong, LI Chao, SUN Han
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Zhejiang Institute for Food and Drug Control, Hangzhou 310052, China
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| Abstract: |
| 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 of D 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. |
| Key words: ethylene oxide biological indicator D value |
