不同脱气方式对溶出介质中溶氧量的影响  

Effect of dissolved oxygen in dissolution medium by different deaerat ion methods

作　　者：何欢 安京烨 李潇 张喆 He Huan;An Jingye;Li Xiao;Zhang Zhe(Beijing Institute for Drug Control(Beijing Center For Vaccine Control)·NMPA Key Laboratory for Research and Evaluation of Generic Drugs·Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China;Beijing Institute of Medical Device Testing·NMPA Key Laboratory for Quality Evaluation of In Vitro Diagnostics·Beijing Key Laboratory of Medical Device Testing and Safety Evaluation,Beijing 101111,China)

机构地区：[1]北京市药品检验研究院(北京市疫苗检验中心)·国家药品监督管理局仿制药研究与评价重点实验室·中药成分分析与生物评价北京市重点实验室,北京102206 [2]北京市医疗器械检验研究院·国家药品监督管理局体外诊断试剂质量评价重点实验室·医疗器械检验与安全性评价北京市重点实验室,北京101111

出　　处：《首都食品与医药》2023年第19期150-153,共4页Capital Food Medicine

摘　　要：目的通过测定纯化水经不同脱气方式后的溶氧曲线,比较实验室常用脱气方式的脱气效果。方法采用《中国药典》2020年版通则0931溶出度测定第二法(桨法),转速75rpm,测定纯化水经氮气、超声、脱气机、煮沸、过滤等不同脱气方式后24小时内溶氧量的变化,比较各种脱气方式的脱气效果。结果与结论60分钟内脱气效果排序为氮气>煮沸>在线真空脱气仪>非在线真空脱气仪>抽滤>超声,超声脱气几乎无效果,4小时后不同的脱气方式溶氧量逐渐趋同。先配制溶出介质后脱气溶氧量低于先脱气后配制溶出介质。Objective To compare the effectiveness of different deaeration methods in lab by measuring the amount of dissolved oxygen curve in water.Methods According to the second method in General Chapter 0931 in Chinese Pharmacopoeia 2020 with strring speed at 75rpm,measuring the amount of dissolved oxygen in water by different deaeration methods such as Nitrogen deaeration,ultrasound,vacuum degassing machine,boiling,filtration etc.Results and Conclusion The deaeration effect within sixty minutes was ranked as nitrogen>boiling>online vacuum degassing machine>offline vacuum degassing machine>filtration>ultrasound.Ultrasound was almost ineffective.After four hours the amount of dissolved oxygen in any medium tend to be no difference.The amount of dissolved oxygen in deaerated medium is lower than the medium preparing with deaerated water.

关 键 词：脱气方式 溶出介质 溶氧量 

分 类 号：R917[医药卫生—药物分析学]