Article(id=1239148843967771403, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239148837584040649, articleNumber=null, orderNo=null, doi=10.16155/j.0254-1793.2024.03.13, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1692028800000, receivedDateStr=2023-08-15, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1773365706673, onlineDateStr=2026-03-13, pubDate=1711814400000, pubDateStr=2024-03-31, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773365706673, onlineIssueDateStr=2026-03-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773365706673, creator=13701087609, updateTime=1773365706673, updator=13701087609, issue=Issue{id=1239148837584040649, tenantId=1146029695717560320, journalId=1205117023404326918, year='2024', volume='44', issue='3', pageStart='373', pageEnd='552', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773365705152, creator=13701087609, updateTime=1773367146269, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1239154882125550205, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239148837584040649, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1239154882125550206, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239148837584040649, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=475, endPage=481, ext={EN=ArticleExt(id=1239148845494498101, articleId=1239148843967771403, tenantId=1146029695717560320, journalId=1205117023404326918, language=EN, title=Study on application application of gas detector tubes in medical gases*, columnId=1206272757852074373, journalTitle=Chinese Journal of Pharmaceutical Analysis, columnName=Safety Monitoring, runingTitle=null, highlight=null, articleAbstract=
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 H2O detection tube,and ambient humidity also has an impact on the CO2 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.

, correspAuthors=Shu-jun HU, Ying CHEN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Xiu-jin YE, Cai-mei WANG, miao WANG, Shu-jun HU, Ying CHEN), CN=ArticleExt(id=1239148847155442618, articleId=1239148843967771403, tenantId=1146029695717560320, journalId=1205117023404326918, language=CN, title=气体检测管在药用气体中的应用研究*, columnId=1206272758036623764, journalTitle=药物分析杂志, columnName=安全监测, runingTitle=null, highlight=null, articleAbstract=
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H2O检测管的检测,环境湿度对B厂家生产的CO2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。

, correspAuthors=胡淑君, 陈英, authorNote=null, correspAuthorsNote=
**胡淑君 Tel:(020)81853646;E-mail:;
陈英 Tel:(020)81853846;E-mail:
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Tel:(020)81853846;E-mail:

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The results of accuracy and precision

, figureFileSmall=null, figureFileBig=null, tableContent=
编号
(No.)
检测管
(detector tube)
数值
(value)/(×10-6n=5)
RSD/%标示值
(listed value)/(×10-6)
相对误差
(relative error)/%
标准气体1(standard gas 1)C-YCO22990.83041.7
C-YCO5.005.112.2
B-YCO23123.62994.3
A-YCO230002990.3
B-HPH31.042.21.004.0
标准气体5(standard gas 5)B-HNOX5.50.95.61.2
标准气体6(standard gas 6)A-HNH324.3025.093.1
标准气体8(standard gas 8)C-YPH31.012.21.001.0
O2C-YH2O101.91.8103.83(冷镜式露点仪测定)(detected by chilled-mirror dew-point hygrometer)1.1
), ArticleFig(id=1239171009270567053, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239148843967771403, language=CN, label=表1, caption=

精密度和准确性考察结果

, figureFileSmall=null, figureFileBig=null, tableContent=
编号
(No.)
检测管
(detector tube)
数值
(value)/(×10-6n=5)
RSD/%标示值
(listed value)/(×10-6)
相对误差
(relative error)/%
标准气体1(standard gas 1)C-YCO22990.83041.7
C-YCO5.005.112.2
B-YCO23123.62994.3
A-YCO230002990.3
B-HPH31.042.21.004.0
标准气体5(standard gas 5)B-HNOX5.50.95.61.2
标准气体6(standard gas 6)A-HNH324.3025.093.1
标准气体8(standard gas 8)C-YPH31.012.21.001.0
O2C-YH2O101.91.8103.83(冷镜式露点仪测定)(detected by chilled-mirror dew-point hygrometer)1.1
), ArticleFig(id=1239171009367036055, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239148843967771403, language=EN, label=Tab.2, caption=

The effects of gas pressure,flow rate and measuring time

, figureFileSmall=null, figureFileBig=null, tableContent=
编号
(No.)
检测管
(detector tube)
气体压力的影响
(the effects of gas pressure)
气体流速的影响
(the effects of gas flow rate)
测定时长的影响
(the effects of measuring time)
压力
(pressure)/MPa
数值
(value)/(×10-6)
流速
(flow rate)/(L·min-1)
数值
(value)/(×10-6)
回归方程
(regression equation)
r
标准气体2
(standard gas 2)
B-YCO20.01 150 0.5280 Y=227.7X-74.840.985 0
0.10 300 1300
0.15 700 2320
标准气体2
(standard gas 2)
A-YCO20.05 120 0.04100 Y=64.05X-8.2140.999 1
0.10300 0.10300
0.20 510 0.50480
标准气体1
(standard gas 1)
C-YCO20.052900.1130 Y=53.41X+6.9320.996 9
0.103000.2300
0.203100.3460
O2C-YH2O0.0575240 Y=8.571X-12.000.995 4
0.1075475
0.15805120
标准气体8
(standard gas 8)
C-YPH30.051.00.050.4 Y=1.403X-0.249 40.993 9
0.101.00.101.0
0.201.00.201.9
标准气体2
(standard gas 2)
B-HPH30.05 0.950.05 0.13 Y=1.200X-0.116 70.998 8
0.10 1.05 0.10 1.05
0.15 1.130.20超量程(over the limit)
标准气体5
(standard gas 5)
B-HNOX0.05 5.40.05 2.5 Y=8.369X-2.2520.992 9
0.10 5.50.105.5
0.15 5.50.2013
标准气体6
(standard gas 6)
A-HNH30.0525.60.056.65//
0.1025.60.13325.6
0.2025.60.35超量程(over the limit)
), ArticleFig(id=1239171009484476574, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239148843967771403, language=CN, label=表2, caption=

气体压力、流速和测定时长的影响

, figureFileSmall=null, figureFileBig=null, tableContent=
编号
(No.)
检测管
(detector tube)
气体压力的影响
(the effects of gas pressure)
气体流速的影响
(the effects of gas flow rate)
测定时长的影响
(the effects of measuring time)
压力
(pressure)/MPa
数值
(value)/(×10-6)
流速
(flow rate)/(L·min-1)
数值
(value)/(×10-6)
回归方程
(regression equation)
r
标准气体2
(standard gas 2)
B-YCO20.01 150 0.5280 Y=227.7X-74.840.985 0
0.10 300 1300
0.15 700 2320
标准气体2
(standard gas 2)
A-YCO20.05 120 0.04100 Y=64.05X-8.2140.999 1
0.10300 0.10300
0.20 510 0.50480
标准气体1
(standard gas 1)
C-YCO20.052900.1130 Y=53.41X+6.9320.996 9
0.103000.2300
0.203100.3460
O2C-YH2O0.0575240 Y=8.571X-12.000.995 4
0.1075475
0.15805120
标准气体8
(standard gas 8)
C-YPH30.051.00.050.4 Y=1.403X-0.249 40.993 9
0.101.00.101.0
0.201.00.201.9
标准气体2
(standard gas 2)
B-HPH30.05 0.950.05 0.13 Y=1.200X-0.116 70.998 8
0.10 1.05 0.10 1.05
0.15 1.130.20超量程(over the limit)
标准气体5
(standard gas 5)
B-HNOX0.05 5.40.05 2.5 Y=8.369X-2.2520.992 9
0.10 5.50.105.5
0.15 5.50.2013
标准气体6
(standard gas 6)
A-HNH30.0525.60.056.65//
0.1025.60.13325.6
0.2025.60.35超量程(over the limit)
), ArticleFig(id=1239171009580945574, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239148843967771403, language=EN, label=Tab.3, caption=

The effects of manufactures or different application of detection tubes

, figureFileSmall=null, figureFileBig=null, tableContent=
编号
(No.)
检测管
(detector tube)
数值
(value)/(×10-6)
标准气体2(standard gas 2)B-YCO7.5
B-HCO7.7
D-HCO8.0(不明显)(indistinct)
A-HCO8.0
标准气体2(standard gas 2)A-YCO2300
A-HCO2400
B-YCO2300
B-HCO2370
标准气体2(standard gas 2)A-HPH31.20
B-HPH31.05
标准气体7(standard gas 7)A-HAsH31.27
A-HPH31.17
B-HPH32.00
C-HPH3>1.0
标准气体1(standard gas 1)B-YCO5
C-YCO5
C-HCO5
标准气体1(standard gas 1)B-YCO2300
A-YCO2300
C-HCO2300
C-YCO2300
), ArticleFig(id=1239171009673220269, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239148843967771403, language=CN, label=表3, caption=

不同厂家或不同用途检测管的影响

, figureFileSmall=null, figureFileBig=null, tableContent=
编号
(No.)
检测管
(detector tube)
数值
(value)/(×10-6)
标准气体2(standard gas 2)B-YCO7.5
B-HCO7.7
D-HCO8.0(不明显)(indistinct)
A-HCO8.0
标准气体2(standard gas 2)A-YCO2300
A-HCO2400
B-YCO2300
B-HCO2370
标准气体2(standard gas 2)A-HPH31.20
B-HPH31.05
标准气体7(standard gas 7)A-HAsH31.27
A-HPH31.17
B-HPH32.00
C-HPH3>1.0
标准气体1(standard gas 1)B-YCO5
C-YCO5
C-HCO5
标准气体1(standard gas 1)B-YCO2300
A-YCO2300
C-HCO2300
C-YCO2300
), ArticleFig(id=1239171009757106358, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239148843967771403, language=EN, label=Tab.3, caption=

The results of interfered gas

, figureFileSmall=null, figureFileBig=null, tableContent=
编号
(No.)
检测管
(detector tube)
数值(value)/
(×10-6)
理论值(theoretical values)/(×10-6)备注
(comment)
标准气体1(平衡气:O2
(standard gas 1 has O2 as its equilibrium gas)
B-YCO55.11
C-YCO55.11
B-YCO2300304
A-YCO2300304
C-YCO2300304
A-YNOX1.742.80有干扰,可能为CO和CO2
(interference present,might be CO or CO2)
B-HCO5.55.11
A-HCO55.11
C-HCO55.11
B-HCO2300304
C-HCO2300304
B-HNOX22.8有干扰,可能为CO和CO2
(interference present,might be CO or CO2)
A-HNOX0.72.8有干扰,可能为CO和CO2
(interference present,might be CO or CO2)
A-HNO222.8有干扰,可能为CO和CO2
(interference present,might be CO or CO2)
C-YNOX1.32.8有干扰,可能为CO和CO2
(interference present,might be CO or CO2)
标准气体3(平衡气:CO2
(standard gas 3 has CO2 as its equilibrium gas)
B-YCO55.21
B-YH2O未检出(undetectable)<1
A-YH2O88.30<1水分量少,检测管变为浅绿色
(Trace amount of water,light green present)
B-HNOX22.5有干扰,可能为SO2、CO和CO2
(interference present,might be SO2,CO or CO2)
A-HNOX超量程(over the limit)2.5有干扰,可能为SO2、CO和CO2
(interference present,might be SO2,CO or CO2)
A-YNOX22.5有干扰,可能为SO2、CO和CO2
(interference present,might be SO2,CO or CO2
A-HSO2超量程(over the limit)2.00CO2有干扰(interference present by CO2)
C-YSO222.00
标准气体4(平衡气:CO2
(standard gas 3 has CO2 as its equilibrium gas)
A-YH2O57.05<1水分量少,检测管变为黄绿色
(trace amount of water,yellow green present)
B-HNOX1.22.9CO2干扰(interference present by CO2)
A-HNOX1.02.9CO2干扰(interference present by CO2)
A-HNO21.02.9CO2干扰(interference present by CO2)
H-HNO2显色浅,无法读数
(too instinct,unable to read)
2.9CO2干扰(interference present by CO2)
C-YNOX1.72.9CO2干扰(interference present by CO2)
标准气体8(平衡气:CO2
(standard gas 8 has CO2 as its equilibrium gas)
A-YH2O超量程(over the limit)<1水分量少,检测管变为黄绿色
(trace amount of water,yellow green present)
B-HH2S2.751.00PH3与H2S测定相互干扰
A-HH2S超量程(over the limit)1.00(mutual interference of PH3 and H2S)
B-HPH32.00.993
A-HPH31.530.993
A-HAsH31.520.993
C-YH2S0.951.00
C-YPH31.00.993
), ArticleFig(id=1239171009874546879, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239148843967771403, language=CN, label=表3, caption=

干扰测定结果

, figureFileSmall=null, figureFileBig=null, tableContent=
编号
(No.)
检测管
(detector tube)
数值(value)/
(×10-6)
理论值(theoretical values)/(×10-6)备注
(comment)
标准气体1(平衡气:O2
(standard gas 1 has O2 as its equilibrium gas)
B-YCO55.11
C-YCO55.11
B-YCO2300304
A-YCO2300304
C-YCO2300304
A-YNOX1.742.80有干扰,可能为CO和CO2
(interference present,might be CO or CO2)
B-HCO5.55.11
A-HCO55.11
C-HCO55.11
B-HCO2300304
C-HCO2300304
B-HNOX22.8有干扰,可能为CO和CO2
(interference present,might be CO or CO2)
A-HNOX0.72.8有干扰,可能为CO和CO2
(interference present,might be CO or CO2)
A-HNO222.8有干扰,可能为CO和CO2
(interference present,might be CO or CO2)
C-YNOX1.32.8有干扰,可能为CO和CO2
(interference present,might be CO or CO2)
标准气体3(平衡气:CO2
(standard gas 3 has CO2 as its equilibrium gas)
B-YCO55.21
B-YH2O未检出(undetectable)<1
A-YH2O88.30<1水分量少,检测管变为浅绿色
(Trace amount of water,light green present)
B-HNOX22.5有干扰,可能为SO2、CO和CO2
(interference present,might be SO2,CO or CO2)
A-HNOX超量程(over the limit)2.5有干扰,可能为SO2、CO和CO2
(interference present,might be SO2,CO or CO2)
A-YNOX22.5有干扰,可能为SO2、CO和CO2
(interference present,might be SO2,CO or CO2
A-HSO2超量程(over the limit)2.00CO2有干扰(interference present by CO2)
C-YSO222.00
标准气体4(平衡气:CO2
(standard gas 3 has CO2 as its equilibrium gas)
A-YH2O57.05<1水分量少,检测管变为黄绿色
(trace amount of water,yellow green present)
B-HNOX1.22.9CO2干扰(interference present by CO2)
A-HNOX1.02.9CO2干扰(interference present by CO2)
A-HNO21.02.9CO2干扰(interference present by CO2)
H-HNO2显色浅,无法读数
(too instinct,unable to read)
2.9CO2干扰(interference present by CO2)
C-YNOX1.72.9CO2干扰(interference present by CO2)
标准气体8(平衡气:CO2
(standard gas 8 has CO2 as its equilibrium gas)
A-YH2O超量程(over the limit)<1水分量少,检测管变为黄绿色
(trace amount of water,yellow green present)
B-HH2S2.751.00PH3与H2S测定相互干扰
A-HH2S超量程(over the limit)1.00(mutual interference of PH3 and H2S)
B-HPH32.00.993
A-HPH31.530.993
A-HAsH31.520.993
C-YH2S0.951.00
C-YPH31.00.993
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气体检测管在药用气体中的应用研究*
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叶秀金 , 王彩媚 , 王淼 , 胡淑君 ** , 陈英 **
药物分析杂志 | 安全监测 2024,44(3): 475-481
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药物分析杂志 | 安全监测 2024, 44(3): 475-481
气体检测管在药用气体中的应用研究*
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叶秀金 , 王彩媚, 王淼, 胡淑君** , 陈英**
作者信息
  • 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
  • Tel:(020)81853846;E-mail:

通讯作者:

**胡淑君 Tel:(020)81853646;E-mail:;
陈英 Tel:(020)81853846;E-mail:
Study on application application of gas detector tubes in medical gases*
Xiu-jin YE , Cai-mei WANG, miao WANG, Shu-jun HU** , Ying CHEN**
Affiliations
  • Guangdong Institute for Drug Control,CFDA Key Laboratory of Quality Control and Evaluation of Pharmaceutical Excipients,Guangzhou 510663,China
出版时间: 2024-03-31 doi: 10.16155/j.0254-1793.2024.03.13
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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H2O检测管的检测,环境湿度对B厂家生产的CO2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。

气体  /  检测管  /  应用  /  杂质  /  影响因素
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 H2O detection tube,and ambient humidity also has an impact on the CO2 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.

gas  /  detector tubes  /  application  /  impurities  /  influence factors
叶秀金, 王彩媚, 王淼, 胡淑君, 陈英. 气体检测管在药用气体中的应用研究*. 药物分析杂志, 2024 , 44 (3) : 475 -481 . DOI: 10.16155/j.0254-1793.2024.03.13
Xiu-jin YE, Cai-mei WANG, miao WANG, Shu-jun HU, Ying CHEN. Study on application application of gas detector tubes in medical gases*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (3) : 475 -481 . DOI: 10.16155/j.0254-1793.2024.03.13
药用气体包括O2、CO2和N2等,在医疗和制剂生产中广泛应用。检测气体杂质的方法有气相色谱法[12]、光谱法[3]、化学法[4]。气相色谱法测定气体中的CO和CO2,通常要将其转化为甲烷,用氢火焰离子化检测器(FID)检测[1],而测定其他气体杂质如H2S则需要用火焰光度检测器(FPD)[4],且气体一般使用钢瓶保存,取样时易受污染,造成测定值的偏差,使用气体色谱法测定气体杂质烦琐、费时,成本较高。光谱法通常采用非散红外吸收法或紫外吸收法[3],但仪器成本较高,而化学法需要耗费较多人力。
气体检测管具有便携、操作简单、准确稳定、特异性强[5-7]等特点,作为精密检测方法的一种补充,得到了广泛的应用。为了适应市场的需求,研制各种各样的检测管[8-11],这些检测管大多用于环境污染检测。然而,药用气体纯度较高,其杂质的含量较低,很多检测管并不适用。目前,市售药用气体中检测微量和半微量气体杂质的检测管生产厂家有Drâger、Kitagawa、Gastec、Honeywell和北京劳保所等。
气体检测管收载于英国药典、欧洲药典及美国药典中,应用于医药工业用气的检测[12-14]。但国内相关行业对气体检测管的了解较少,经调研,气体检测管分为不同类型,易造成混用、乱用等情况。本文介绍气体检测管的原理和装置,研究气体检测管的准确度与精密度、影响因素考察、通用性考察等,根据考察结果提出注意事项,并应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。
CO、CO2、SO2、PH3、H2S、NH3、H2O、NOX、油等环境气体检测管来自于A、B、C、D 4个厂家;CO、CO2、SO2、PH3、H2S、NH3、H2O、NOX、油等压缩气体检测管自于A、B、C 3个厂家。
标准气体1(以O2为平衡气,含CO 0.000 511%、CO20.030 4%、NO2 0.000 28%,200422-L172310189);标准气体2(以N2为平衡气,含CO 0.000 516%、CO2 0.029 9%、PH3 0.000 1%,00424-200308163);标准气体3(以CO2为平衡气,含CO 0.000 521%、NO 0.000 250%、SO2 0.000 200%,200422-L176902173);标准气体4(以CO2为平衡气,含NO2 0.000 290%,200511-L175403045);标准气体5(以N2为平衡气,含NO 0.000 260%、NO2 0.000 300%,200521-L176902039);标准气体6(以N2为平衡气,含NH30.002 509%,200424-L180104094);标准气体7(以N2为平衡气,含AsH30.000 100%,200424-200308157);标准气体8(以CO2为平衡气,含H2S 0.000 100%、PH3 0.000 099 3%,200424-L33008048);标准气体均来自于大连大特气体有限公司。待测气体CO2、N2、O2各9批,分别来自于3个厂家,每个厂家各3批,均为压缩气体。
气体检测管是一种允许气体通过的圆柱形透明管,其两端熔封、内含惰性载体,载体上涂有化学试剂以及必要的用于消除干扰物质的预处理层或过滤器,一般用于检测气体中的杂质。如CO检测管,其包含吸附过滤器和钯盐或五氧化二碘及发烟硫酸等指示剂,当气体通过检测管,与管内试剂反应,变色长度发生变化,可读出该数值[12-13]
药用气体检测的检测管取样装置有2种,一种是恒流装置,适用于压缩气体,一种是手泵装置,适用于压缩气体及环境气体[14-15]
恒流测定法原理为气体经过减压阀减压,再通过针阀或流量计控制调节气体流速,然后在规定的时间内气体检测管通过一定量的气体,从而测定气体杂质含量。无论是否配套装置,过程中只要保证通过气体的压力、流速恒定,连接处不漏气即可。装置简图如图1所示。A为待测气体;B为用于降低待测气体压力的减压阀,与A相连,最小压力可调节至0.05 MPa;C为可调节待测气体流速的针阀或流量计,根据检测管的说明书,选择不同量程的针阀或流量计;D为两端均已割断的气体检测管。
测定时按图1所示连接装置A、B、C,打开气体及减压阀阀门,调整至气体检测管说明书所规定的压力,拧动针阀或流量计阀门,调整至规定的流速,用待测气体冲洗管路,待压力和流速恒定后,插入D,计时,到规定时间后关闭阀门,拔出D,读取检测管上颜色层长度或强度相对应的值,即为待测气体杂质的含量。
手泵测定法原理为气体经减压阀减压,手泵连接检测管从三通旁路或采样袋按要求使用固定体积(如100 mL)的手泵采样,通过控制泵数使规定量的气体通过气体检测管。装置如图2所示。A为待测气体;B为用于降低待测气体压力的减压阀,与A相连,最小压力可调节至0.05 MPa(如为环境气体则不需要减压阀);C为连接B和E的三通管;D为气体主路,直通大气;E为气体检测管;F为手泵。其中,C、D可用采样袋取代。
测定时按图2所示连接装置A、B、C,打开气体及减压阀阀门,用待测气体冲洗管路,插入E,使用F抽取规定气体泵数,取样后拔出E及F,关闭阀门,读取检测管上颜色层长度或强度相对应的值,即为待测气体杂质的含量。
市售气体检测管按用途分为压缩气体检测管和环境气体检测管,分别用于检测压缩气体和环境气体。试验考察发现,各厂家环境气体检测管插入恒流装置后,流速不稳定,造成结果差异大,“3.4.6”项结果亦显示部分环境气体检测管采用恒流装置准确性差,而压缩气体检测管通常采样量较大,不适宜采用手泵装置。故恒流装置一般使用压缩气体检测管,手泵装置一般使用环境气体检测管,也有2种装置均运用的检测管。
检测管的准确度与精密度会影响测定结果,按“3.1.1”项方法对标准气体和待测气体O2(批号:20201013)进行测定,并对比标示值,计算相对误差,结果见表1。结果显示,各检测管精密度与准确度良好。
影响气体检测管检测的主要因素有压力、流速、测定时长、环境湿度、环境温度、不同厂家或不同用途检测管、对测试存在干扰的气体等。
取A、B、C 3个厂家的检测管,采用“3.1.1”方法,固定流速和通气时长考察不同压力对测定的影响,结果见表2。结果显示,A、B 2个厂家生产的压缩气体检测管受压力影响较大,随压力增加测定值增大,而C厂生产的压缩气体检测管及各厂家环境气体检测管受压力影响较小。提示可能受各生产厂家技术的影响,使用检测管时压力应严格按说明书要求调整,如有变化,则需按说明书规定的校正值进行校正后取值。
取A、B、C 3个厂家的检测管,采用“3.1.1”项方法固定压力和通气时长考察不同流速对测定结果的影响,结果见表2。结果显示,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,流速越大测定值越大,可能原因为气体量较多,且气体中的杂质可能未完全与检测管内试剂反应,造成扩散,读数可能偏大。B厂生产的压缩气体检测管受流速影响较小,提示有可能受各厂家生产技术的影响,流速设定应严格按说明书要求。
取A、B、C 3个厂家的检测管,采用“3.1.1”方法,在规定的压力和流速条件下,考察了不同的通气时长的影响。结果见表2。结果显示,测定时间越长,数值越大,压缩气体检测管及环境气体检测管在一定范围内呈线性关系,相关系数(r)大于0.985,但部分检测管随着检测时长的增长边界变得模糊,不易于观察,如B厂家生产的CO压缩气体检测管,提示应按说明书规定的时长检测,如需改变时长,则需经过验证。
环境中的水分有可能会引入检测管与试剂反应,可使显示值产生偏差,对气体检测管的检测有影响。试验取说明书中明确对湿度影响较大的检测管和经理论分析湿度可能对测定结果有影响的CO、CO2、PH3和H2O检测管,采用“3.1”项方法在高、中、低湿度条件下进行考察。结果环境湿度对B厂家生产的CO2环境气体检测管有影响,测定值为0.023 0%~0.038 0%,环境湿度越高数值越小;环境湿度对H2O检测管测定结果有影响,测定值为0.019 0%~0.023 0%,环境湿度越高,测定值越大;环境湿度对于其他检测管影响较小。分析推测CO2和H2O等气体杂质如在预处理层加入H2O的吸附剂会影响其检测结果,故测定时应关注说明书检测湿度的要求。
当温度不同时,气体生物体积发生变化,检测管内载体对气体的吸附量发生变化,气体与指示剂发生化学反应速度发生变化,作用各不相同[16]。取A、B、C 3个厂家的CO、CO2、PH3和H2O检测管,采用“3.1”项方法,在相对湿度相对固定条件下,考察不同温度对测定结果的影响。结果环境温度对H2O检测管测定结果有影响,测定值为0.007 2%~0.008 0%,原因可能为在温度较高的条件下,检测管内的载体对水分的吸附量变少,测定值较大,但测定结果误差在可接受范围(±25%),其他检测管基本无影响。但对检测管考察的范围比较有限,尚未全范围覆盖,测定时也需按说明书进行实验。
取A、B、C、D 4个厂家的检测管,采用“3.1.1”方法,考察不同厂家及环境气体检测管和压缩气体检测管检测结果的差别,结果见表3。结果提示,不同厂家的检测管差异性较小,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。提示气体杂质测定时应使用相适应的装置。
气体中多种杂质的存在可能有相互影响,在实验设计中,设置了部分标准气体作为干扰气,用于验证气体检测管中说明书注明有干扰的物质是否存在干扰。取A、B、C 3个厂家的检测管,采用“2.2”方法考察干扰气的影响,结果见表3
在NOX检测管的说明书中显示,CO和CO2的存在会影响气体检测管的检测,试验在标准气体1、标准气3和标准气体4的检测中也证明了这一点,有可能CO2与指示剂反应活性与NOX不同造成读数偏低。CO2的存在也会影响SO2的检测,在标准气体3的检测中,因A厂生产的SO2环境气体检测管中的试剂为NaOH、BaCl2均可以与CO2反应,对测定结果有影响,但C厂生产的SO2压缩气体检测管原理为SO2与I2反应,CO2不能与其试剂反应,故对其检测无影响。H2S和PH3均能与检测管中的金属盐反应,二者的检测可产生相互干扰,而C厂生产的检测管可能技术不一致,在这2种物质的检测中不存在干扰。在各标准气的测定中,A厂生产的H2O压缩气体检测管均有显色,有可能受环境湿度的干扰,检测管灵敏度高,微量的水分也能使检测管显浅绿色,易引起误判,在选择检测管时应注意。结果提示,应注意说明书中存在干扰的情况,选取合适的检测管。
以O2、N2、CO2压缩气体为代表品种,每个品种3个生产厂家各3批,共27批样品,按“3.1.1”项方法检测了3种气体中CO、CO2、H2O、油、NOX、PH3、SO2和H2S等气体杂质。结果27批样品中均检出H2O,部分批次超过0.021 7%;CO2中部分批次检出CO及油,CO最大检出量为0.003 8%,油最大量为超过0.000 5%;A和B 2个厂家生产的SO2检测管不能用于CO2中SO2的检测,存在干扰。
本研究介绍了气体检测管的原理和装置的分类,提醒使用者恒流装置一般使用压缩气体检测管,手泵装置一般使用环境气体检测管,但也存在2种装置均运用的检测器。通过研究气体检测管的准确度与精密度、影响因素等,提示在使用气体检测管时,应按气体检测管说明书中的要求,注意气体压力、流速、时长、环境温度、环境湿度和干扰气等影响因素对测定结果的影响,选择合适的气体检测管,以防结果的误差。该方法准确度与精密度良好,可用于药用气体的检测中,为药用气体中杂质气体检测的提供参考。
  • *广东省药品监督管理局科技创新项目(2022TDZ06)
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doi: 10.16155/j.0254-1793.2024.03.13
  • 接收时间:2023-08-15
  • 首发时间:2026-03-13
  • 出版时间:2024-03-31
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  • 收稿日期:2023-08-15
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*广东省药品监督管理局科技创新项目(2022TDZ06)
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    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

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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

Genus
种数
Number of
species
占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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