细菌内毒素工作标准品使用和保存方法的探讨  

Discussion on the use and preservation methods of control standard endotoxin

作　　者：王莉 苟志梅 白春昀 王莹[1] WANG Li;GOU Zhimei;BAI Chunyun;WANG Ying(Ministry of Industry and Information Technology Industrial Technology Basic Public Service Platform,Yunnan Institute for Food and Drug Control,Kunming 650106,China)

机构地区：[1]云南省食品药品监督检验研究院,工业和信息化部产业技术基础公共服务平台,云南昆明650106

出　　处：《药学研究》2025年第3期253-256,共4页Journal of Pharmaceutical Research

摘　　要：目的对细菌内毒素工作标准品使用和保存方法进行研究探讨,以达到合理、节约使用标准品,减少浪费的目的。方法按《中国药典》2020年版(四部)1143细菌内毒素检查法鲎试剂灵敏度复核进行试验,4℃冷藏保存复溶后的细菌内毒素工作标准品溶液,并在不同保存时间进行灵敏度复核试验,比较灵敏度复核试验的结果变化。同时将细菌内毒素工作标准品溶液用动态浊度法测定相同浓度、不同保存时间反应达终点的时间,比较反应时间的变化。结果复溶后的细菌内毒素工做标准品溶液在4℃冷藏保存,凝胶法约9 d内效价无明显变化;动态浊度法7 d内反应达终点时间无显著性差异。结论中国食品药品检定研究院生产标定发行的细菌内毒素工作标准品复溶后可在4℃冷藏条件下保存并使用7 d。Objective To study the use and preservation methods of control standard endotoxin(CSE),in order to reasonable and economical use it,and reduce waste.Methods According to the Appendix of China Pharmacopoeia in 2020 Vol Ⅲ 1143"Bacterial endotoxins test"and"Test for confirmation of labeled lysate sensitivity",dissolve and store the control standard endotoxin solution at 4℃.Then take the test of labeled lysate sensitivity at different storage times and compare the changes in the results of it.Measure the reaction time of endpoint at the same concentration but different storage times with turbidimetric technique at the same time,and compare the changes in the reaction time.Results Control standard endotoxin solution can be used for gel-clot technique within 9 days when it is stored at 4℃,and there is no statistical significance in turbidimetric technique reaction time of endpoint within 7 days.Conclusion Control standard endotoxin produced and calibrated by NIFDC can be used for 7 days after it is dissolved and stored at 4℃.

关 键 词：细菌内毒素工作标准品 保存时间 稳定性 

分 类 号：R927.1[医药卫生—药学]