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作 者:叶秀金[1] 王彩媚[1] 王淼[1] 胡淑君 陈英[1] YE Xiu-jin;WANG Cai-mei;WANG miao;HU Shu-jun;CHEN Ying(Guangdong Institute for Drug Control,CFDA Key Laboratory of Quality Control and Evaluation of Pharmaceutical Excipients,Guangzhou 510663,China)
机构地区:[1]广东省药品检验所,国家药品监督管理局药用辅料质量控制与评价重点实验室,广州510663
出 处:《药物分析杂志》2024年第3期475-481,共7页Chinese Journal of Pharmaceutical Analysis
基 金:广东省药品监督管理局科技创新项目(2022TDZ06)。
摘 要:目的:建立一种药用气体中杂质气体的测定方法。方法:本研究介绍了气体检测管的原理和装置,考察了其准确性、精密度和影响因素等,并用于药用气体中气体杂质的检测。结果:A、B 2个厂家生产的压缩气体检测管受压力影响较大;A、C 2个厂家生产的压缩气体检测管及各厂家环境气体检测管受流速影响较大;气体检测管受测定时间影响;环境温度和湿度均可影响H_(2)O检测管的检测,环境湿度对B厂家生产的CO_(2)环境气体检测管也有影响;不同厂家的检测管在同一检测条件下差异性较小,压缩气体检测管在恒流装置下能准确测定气体杂质含量,而部分环境气体检测管不能准确测定;不同原理的检测管杂质干扰不同。提示在气体检测管使用时关注影响因素,选择合适的检测管和方法。结论:本法准确性和精密度较好,可用于药用气体的检测中,为药用气体中杂质气体的检测提供参考。Objective:To establish a method for determination of gas impurities in medical gases.Methods:The study introduced the principle and measurement system of gas detector tubes,and researched on the accuracy,precision and influence factors.The method was applied to the detection of gas impurities in medicinal gases.Results:The test results showed that the compressed gas detection tubes produced by manufacturer A and manufacturer B were greatly affected by the pressure.The compressed gas detection tubes produced by manufacturer A and manufacturer C and the ambient gas detection tubes of all manufacturers were greatly affected by the flow rate.All the gas detection tubes were affected by the measurement time.Both ambient temperature and humidity can affect the detection of H_(2)O detection tube,and ambient humidity also has an impact on the CO_(2) ambient gas detection tube produced by manufacturer B.The difference between different manufacturers'detection tubes was indistinct under the same testing conditions.The compressed gas detection tubes can accurately measure the gas impurity content under the continuous flow measurement system,while some ambient gas detection tubes can not accurately measure.The impurity interference was different for the detection tubes with different principles.It is suggested that the influencing factors should be paid attention to when the gas detection tubes are used,and the appropriate detection tubes and method should be selected.Conclusion:The gas detector tubes can be used in the detection of medical gases with good accuracy and precision.This study provides references for the detection of impurities in medical gases.
分 类 号:R917[医药卫生—药物分析学]
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