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Article(id=1239173817705222749, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239173808419033435, articleNumber=null, orderNo=null, doi=10.16155/j.0254-1793.2024.02.14, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=1695139200000, revisedDateStr=2023-09-20, acceptedDate=null, acceptedDateStr=null, onlineDate=1773371660877, onlineDateStr=2026-03-13, pubDate=1709136000000, pubDateStr=2024-02-29, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773371660877, onlineIssueDateStr=2026-03-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773371660877, creator=13701087609, updateTime=1773371660877, updator=13701087609, issue=Issue{id=1239173808419033435, tenantId=1146029695717560320, journalId=1205117023404326918, year='2024', volume='44', issue='2', pageStart='185', pageEnd='372', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773371658663, creator=13701087609, updateTime=1773371757717, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1239174223944536397, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239173808419033435, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1239174223944536398, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239173808419033435, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=307, endPage=315, ext={EN=ArticleExt(id=1239173819227755183, articleId=1239173817705222749, tenantId=1146029695717560320, journalId=1205117023404326918, language=EN, title=Determination of migration of common antioxidants and extractable sulfur in medical rubber stoppers to propofol medium/long chain fat emulsion injection by HPLC, columnId=1206272757852074373, journalTitle=Chinese Journal of Pharmaceutical Analysis, columnName=Safety Monitoring, runingTitle=null, highlight=null, articleAbstract=
Objective:

To establish a high-performance liquid chromatography (HPLC) method for investigating the extraction of common antioxidants and extractable sulfur in medical rubber stoppers and the migration of antioxidants and extractable sulfur to propofol medium/long chain fat emulsion injection.

Methods:

Waters Symmetry RP18(250 mm×4.6 mm，5 μm) was used as chromatographic column with methanol-acetonitrile -1% acetic acid solution as the mobile phase. Detection wavelength, velocity of flow and column temperature were set to 277 nm, 1 mL·min-1 and 35 ℃.

Results:

Good resolution and linear relationship (r≥0.999 6) in the range of 0.1-20 μg·mL-1 were achieved. This method possesses superior precision, stability, repeatability, and all RSD were less than 5%. The rate of recovery was 93.3%-108.7%, and the RSD was 1.8%-12.5%. The migration of antioxidant BHT was detected in three batches of solution and the content was higher than its corresponding permitted daily exposure (PDE) value, which means there is a large safetyrisk.

Conclusion:

The method represents high sensitivity and is easy to operate, which can effectively detect the migration of antioxidants in propofol medium/long chain fat emulsion injection.

, correspAuthors=Luo-hong ZHANG, 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=Jie CHENG, Yan JIANG, Yi-ting QIU, Kun REN, Jin-chi ZHAO, Tian TIAN, Luo-hong ZHANG), CN=ArticleExt(id=1239173819852706529, articleId=1239173817705222749, tenantId=1146029695717560320, journalId=1205117023404326918, language=CN, title=HPLC法测定药用胶塞中常用抗氧剂及可提取硫向丙泊酚中/长链脂肪乳注射液中的迁移, columnId=1206272758036623764, journalTitle=药物分析杂志, columnName=安全监测, runingTitle=null, highlight=null, articleAbstract=
目的：

建立一种高效液相色谱方法（HPLC），用于考察药用胶塞中常用抗氧剂及可提取硫的提取情况，以及药用胶塞中抗氧剂及可提取硫向丙泊酚中/长链脂肪乳注射液的迁移情况。

方法：

采用Waters Symmetry RP18（250 mm×4.6 mm，5 μm）色谱柱，流动相为甲醇-乙腈-1%醋酸水溶液，梯度洗脱，检测波长为277 nm，流速为1 mL·min-1，柱温为35 ℃。

结果：

各组分分离度良好；在0.1~20 μg·mL-1范围内线性关系良好，r≥0.999 6；该方法的精密度、稳定性、重复性均良好，RSD均<5.0%；回收率为93.3%~108.7%，RSD为1.8%~12.5%。检出3批药液中均有抗氧剂BHT的迁移，且含量高于其相应人每日允许最大暴露量（PDE）值，有较大安全性风险。

结论：

该方法具有较高的灵敏度，操作简便，能够用于检测丙泊酚中/长链脂肪乳注射液中抗氧剂的迁移。

, correspAuthors=张罗红, authorNote=null, correspAuthorsNote=
*Tel：13808004672；E-mail：
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Tel：15828617937；E-mail：

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Tel：15828617937；E-mail：

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HPLC法测定胶塞中抗氧剂1076向米卡芬净钠注射液中的迁移[J]. 药物分析杂志，2017，37（7）：1298, articleTitle=HPLC法测定胶塞中抗氧剂1076向米卡芬净钠注射液中的迁移, refAbstract=null), Reference(id=1239173831257018448, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, doi=null, pmid=null, pmcid=null, year=2017, volume=37, issue=7, pageStart=1298, pageEnd=null, url=null, language=null, rfNumber=[14], rfOrder=27, authorNames=PU XC, CHEN R, YOU YJ, journalName=Chin J Pharm Anal, refType=null, unstructuredReference=PU XC， CHEN R， YOU YJ， et al. HPLC determination for migration of antioxidant 1076 from rubber stopper to micafungin sodium injection [J]. 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HPLC法同时测定药用卤化丁基胶塞中17种抗氧剂向注射用伏立康唑中的迁移[J]. 药物分析杂志，2020，40（8）：1481, articleTitle=HPLC法同时测定药用卤化丁基胶塞中17种抗氧剂向注射用伏立康唑中的迁移, refAbstract=null), Reference(id=1239173831416402007, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, doi=null, pmid=null, pmcid=null, year=2020, volume=40, issue=8, pageStart=1481, pageEnd=null, url=null, language=null, rfNumber=[15], rfOrder=29, authorNames=ZHANG X, FU P, XIE H, journalName=Chin J Pharm Anal, refType=null, unstructuredReference=ZHANG X， FU P， XIE H， et al. Determination of migration of 17 antioxidants from pharmaceutical halogenated butyl rubber stopper to voriconazole for injection by HPLC[J]. Chin J Pharm Anal， 2020， 40(8)： 1481, articleTitle=Determination of migration of 17 antioxidants from pharmaceutical halogenated butyl rubber stopper to voriconazole for injection by HPLC, refAbstract=null), Reference(id=1239173831525453914, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, doi=null, pmid=null, pmcid=null, year=2014, volume=23, issue=15, pageStart=1738, pageEnd=null, url=null, language=null, rfNumber=[16], rfOrder=30, authorNames=蒋煜, 马玉楠, 霍秀敏, journalName=中国新药杂志, refType=null, unstructuredReference=蒋煜，马玉楠，霍秀敏. 《化学药品注射剂与塑料包装材料相容性研究技术指导原则》解读-提取迁移试验方法设计[J]. 中国新药杂志，2014，23（15）：1738, articleTitle=《化学药品注射剂与塑料包装材料相容性研究技术指导原则》解读-提取迁移试验方法设计, refAbstract=null), Reference(id=1239173831655477343, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, doi=null, pmid=null, pmcid=null, year=2014, volume=23, issue=15, pageStart=1738, pageEnd=null, url=null, language=null, rfNumber=[16], rfOrder=31, authorNames=JIANG Y, MA YN, HUO XM, journalName=Chin J New Drugs, refType=null, unstructuredReference=JIANG Y， MA YN， HUO XM. Interpretation of the guideline of compatibility study of pharmaceutical products and packaging materials-extract and migration study design[J]. Chin J New Drugs， 2014， 23(15)： 1738, articleTitle=Interpretation of the guideline of compatibility study of pharmaceutical products and packaging materials-extract and migration study design, refAbstract=null), Reference(id=1239173831735169122, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, doi=null, pmid=null, pmcid=null, year=2019, volume=null, issue=null, pageStart=430, pageEnd=null, url=null, language=null, rfNumber=[17], rfOrder=32, authorNames=马玉楠, 蔡弘, 骆红宇, journalName=药品与包装相容性理论与实践, refType=null, unstructuredReference=马玉楠，蔡弘，骆红宇. 药品与包装相容性理论与实践[M]. 北京：化学工业出版社，2019：430, articleTitle=null, refAbstract=null), Reference(id=1239173831819055206, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, doi=null, pmid=null, pmcid=null, year=2019, volume=null, issue=null, pageStart=430, pageEnd=null, url=null, language=null, rfNumber=[17], rfOrder=33, authorNames=MA YN, CAI H, LUO HY, journalName=Theory and Practice Compatibility of Pharmaceutical Products Packaging, refType=null, unstructuredReference=MA YN， CAI H， LUO HY. Theory and Practice Compatibility of Pharmaceutical Products Packaging [M]. Beijing： Chemistry Industry Press， 2019：430, articleTitle=null, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1239173820091781872, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, xref=1., ext=[AuthorCompanyExt(id=1239173820100170482, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, companyId=1239173820091781872, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.Sichuan Institute for Drug Control, Chengdu 610097, China), AuthorCompanyExt(id=1239173820108559090, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, companyId=1239173820091781872, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.四川省药品检验研究院，成都 610097)]), AuthorCompany(id=1239173820192445180, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, xref=2., ext=[AuthorCompanyExt(id=1239173820200833789, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, companyId=1239173820192445180, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.Chengdu Kanghua Biological Products Company Limited, Chengdu 610199, China), AuthorCompanyExt(id=1239173820209222398, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, companyId=1239173820192445180, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.成都康华生物制品股份有限公司，成都 610199)])], figs=[ArticleFig(id=1239173826416792514, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, language=EN, label=Fig.1, caption=HPLC chromatograms of mixed reference solution, figureFileSmall=POI7QbMWLXgmr0mdXV73og==, figureFileBig=+YX1hRBlgg02T1R52/5NpA==, tableContent=null), ArticleFig(id=1239173826513261510, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, language=CN, label=图1, caption=HPLC混合对照品溶液色谱图

抗氧剂（antioxidants）：1.BHT-OH　2.BHT-COOH　3. 1 310　4.BHT-CHO　5.BHT-Q　6. 2，4-DBP　7.BHT　8.可提取硫（extractable sulfur）　9. 3 114　10. 1 010　11. 330　12. 1 076　13. 168

, figureFileSmall=POI7QbMWLXgmr0mdXV73og==, figureFileBig=+YX1hRBlgg02T1R52/5NpA==, tableContent=null), ArticleFig(id=1239173826718782413, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, language=EN, label=Tab. 1, caption=

Regression equation，linear range，limits of detection and limits of quantification

, figureFileSmall=null, figureFileBig=null, tableContent=
化合物
(compound)		回归方程
(regression equation)		r线性范围
（linear range）/（μg·mL-1）		提取试验
(extraction test)		迁移试验
(migration test)
LOD/(μg·g-1)LOQ/(μg·g-1)LOD/(μg·mL-1)LOQ/(μg·mL-1)
BHT-OHY=3 936.5X-505.940.999 80.097~19.470.792.630.080.26
BHT-COOHY=16 472X-1 606.60.999 80.098~19.630.822.730.080.27
1310Y=3 328.5X-178.250.999 90.099~19.701.685.580.170.56
BHT-CHOY=29 407X- 2 889.80.999 80.098~19.620.491.630.050.16
BHT-QY=5 080.6X-572.310.999 80.098~19.520.933.080.090.31
2，4-DBPY=6 456.6X-776.760.999 70.098~19.560.772.560.080.26
BHTY=4 764.9X-479.460.999 80.100~20.021.204.020.120.40
3114Y=2 853.5X-307.240.999 80.101~20.220.882.950.090.29
1010Y=3 248.1X-443.210.999 80.099~19.771.103.670.110.37
1330Y=4 471.4X-604.990.999 70.098~19.600.812.690.080.27
1076Y=1 736.6X-298.110.999 60.100~20.002.137.110.210.71
168Y=2 833.4X-483.90.999 80.099~19.811.675.570.170.56
可提取硫（extractable sulfur）Y=17 091 X-1 255.20.999 80.099~19.741.304.340.130.43
), ArticleFig(id=1239173826815251407, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, language=CN, label=表1, caption=

回归方程、线性范围、检测限和定量限

, figureFileSmall=null, figureFileBig=null, tableContent=
化合物
(compound)		回归方程
(regression equation)		r线性范围
（linear range）/（μg·mL-1）		提取试验
(extraction test)		迁移试验
(migration test)
LOD/(μg·g-1)LOQ/(μg·g-1)LOD/(μg·mL-1)LOQ/(μg·mL-1)
BHT-OHY=3 936.5X-505.940.999 80.097~19.470.792.630.080.26
BHT-COOHY=16 472X-1 606.60.999 80.098~19.630.822.730.080.27
1310Y=3 328.5X-178.250.999 90.099~19.701.685.580.170.56
BHT-CHOY=29 407X- 2 889.80.999 80.098~19.620.491.630.050.16
BHT-QY=5 080.6X-572.310.999 80.098~19.520.933.080.090.31
2，4-DBPY=6 456.6X-776.760.999 70.098~19.560.772.560.080.26
BHTY=4 764.9X-479.460.999 80.100~20.021.204.020.120.40
3114Y=2 853.5X-307.240.999 80.101~20.220.882.950.090.29
1010Y=3 248.1X-443.210.999 80.099~19.771.103.670.110.37
1330Y=4 471.4X-604.990.999 70.098~19.600.812.690.080.27
1076Y=1 736.6X-298.110.999 60.100~20.002.137.110.210.71
168Y=2 833.4X-483.90.999 80.099~19.811.675.570.170.56
可提取硫（extractable sulfur）Y=17 091 X-1 255.20.999 80.099~19.741.304.340.130.43
), ArticleFig(id=1239173826903331797, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, language=EN, label=Tab.2, caption=

Rubber stopper extraction results

, figureFileSmall=null, figureFileBig=null, tableContent=
化合物
(compound)		含量
(content)/(μg·g-1)		每日最大摄入量
(maximum daily intake)/(μg·d-1)		PDE/(μg·d-1)安全
(safe)
BHT-OH<0.79<124.8221 000是(yes)
BHT-COOH<0.82<129.56500是(yes)
1310<1.68<265.44768是(yes)
BHT-CHO<0.49<77.42500是(yes)
BHT-Q<0.93<146.94500是(yes)
2，4-DBP<0.77<121.66240是(yes)
BHT122.2619 317.081 800否(no)
3114<0.88<139.0425 000是(yes)
1010<1.10<173.8010 000是(yes)
330<0.81<127.985 000是(yes)
1076<2.13<336.54768是(yes)
168<1.67<263.869 500是(yes)
可提取硫（extractable sulfur）4.4695.202 000是(yes)
), ArticleFig(id=1239173827012383704, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, language=CN, label=表2, caption=

胶塞提取试验结果

, figureFileSmall=null, figureFileBig=null, tableContent=
化合物
(compound)		含量
(content)/(μg·g-1)		每日最大摄入量
(maximum daily intake)/(μg·d-1)		PDE/(μg·d-1)安全
(safe)
BHT-OH<0.79<124.8221 000是(yes)
BHT-COOH<0.82<129.56500是(yes)
1310<1.68<265.44768是(yes)
BHT-CHO<0.49<77.42500是(yes)
BHT-Q<0.93<146.94500是(yes)
2，4-DBP<0.77<121.66240是(yes)
BHT122.2619 317.081 800否(no)
3114<0.88<139.0425 000是(yes)
1010<1.10<173.8010 000是(yes)
330<0.81<127.985 000是(yes)
1076<2.13<336.54768是(yes)
168<1.67<263.869 500是(yes)
可提取硫（extractable sulfur）4.4695.202 000是(yes)
), ArticleFig(id=1239173827108852699, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, language=EN, label=Tab.3, caption=

The results of recovery measurement

, figureFileSmall=null, figureFileBig=null, tableContent=
化合物
（compound）		样品平均含量
（average content of sample）/(μg·mL-1)		加入量
(added)/(μg·mL-1)		实测量
（measured）/(μg·mL-1)		平均回收率
(average recovery)/%		RSD/%
BHT-OH00.971.10104.812.5
0.971.08
0.970.87
1.951.9097.35.0
1.951.99
1.951.80
4.874.88100.83.3
4.874.76
4.875.08
BHT-COOH00.981.09103.710.8
0.981.07
0.980.89
1.962.01103.15.2
1.962.13
1.961.92
4.915.29108.73.5
4.915.18
4.915.54
BHT-Q00.980.9995.26.6
0.980.94
0.980.78
1.952.06107.02.6
1.952.15
1.952.05
4.885.09105.53.9
4.884.98
4.885.37
BHT0.261.001.37102.312.2
1.001.34
1.001.14
2.002.2096.54.9
2.002.28
2.002.09
5.005.1398.23.1
5.005.04
5.005.34
可提取硫
（extractable sulfur）		01.011.0195.74.2
1.010.96
1.010.93
2.021.9496.05.2
2.022.04
2.021.84
5.054.6693.33.0
5.054.6
5.054.87
), ArticleFig(id=1239173827238876129, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, language=CN, label=表3, caption=

回收率测定结果

, figureFileSmall=null, figureFileBig=null, tableContent=
化合物
（compound）		样品平均含量
（average content of sample）/(μg·mL-1)		加入量
(added)/(μg·mL-1)		实测量
（measured）/(μg·mL-1)		平均回收率
(average recovery)/%		RSD/%
BHT-OH00.971.10104.812.5
0.971.08
0.970.87
1.951.9097.35.0
1.951.99
1.951.80
4.874.88100.83.3
4.874.76
4.875.08
BHT-COOH00.981.09103.710.8
0.981.07
0.980.89
1.962.01103.15.2
1.962.13
1.961.92
4.915.29108.73.5
4.915.18
4.915.54
BHT-Q00.980.9995.26.6
0.980.94
0.980.78
1.952.06107.02.6
1.952.15
1.952.05
4.885.09105.53.9
4.884.98
4.885.37
BHT0.261.001.37102.312.2
1.001.34
1.001.14
2.002.2096.54.9
2.002.28
2.002.09
5.005.1398.23.1
5.005.04
5.005.34
可提取硫
（extractable sulfur）		01.011.0195.74.2
1.010.96
1.010.93
2.021.9496.05.2
2.022.04
2.021.84
5.054.6693.33.0
5.054.6
5.054.87
), ArticleFig(id=1239173827352122340, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, language=EN, label=Tab.4, caption=

Determination of migration in drugs

, figureFileSmall=null, figureFileBig=null, tableContent=
加速时间
(acceleration time)/月（month）		批号
(batch number)		放置方向
(placement direction)		迁移量（migration）/（μg·mL-1）
BHT-OHBHT-COOHBHT-QBHT可提取硫(extractable sulfur）
0181128121正置(upright)<0.08<0.08<0.091.79<0.13
181129121正置(upright)<0.08<0.08<0.092.26<0.13
181130121正置(upright)<0.08<0.08<0.091.80<0.13
3181128121正置(upright)<0.08<0.08<0.092.68<0.13
倒置(upend)<0.08<0.08<0.093.45<0.13
181129121正置(upright)<0.08<0.08<0.092.54<0.13
倒置(upend)<0.08<0.08<0.093.31<0.13
181130121正置(upright)<0.08<0.08<0.092.74<0.13
倒置(upend)<0.08<0.08<0.092.64<0.13
6181128121正置(upright)<0.08<0.08<0.092.86<0.13
倒置(upend)<0.08<0.08<0.093.36<0.13
181129121正置(upright)<0.08<0.08<0.092.47<0.13
倒置(upend)<0.08<0.08<0.093.35<0.13
181130121正置(upright)<0.08<0.08<0.092.92<0.13
倒置(upend)<0.08<0.08<0.093.59<0.13
), ArticleFig(id=1239173827423425512, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, language=CN, label=表4, caption=

药品中迁移量的测定

, figureFileSmall=null, figureFileBig=null, tableContent=
加速时间
(acceleration time)/月（month）		批号
(batch number)		放置方向
(placement direction)		迁移量（migration）/（μg·mL-1）
BHT-OHBHT-COOHBHT-QBHT可提取硫(extractable sulfur）
0181128121正置(upright)<0.08<0.08<0.091.79<0.13
181129121正置(upright)<0.08<0.08<0.092.26<0.13
181130121正置(upright)<0.08<0.08<0.091.80<0.13
3181128121正置(upright)<0.08<0.08<0.092.68<0.13
倒置(upend)<0.08<0.08<0.093.45<0.13
181129121正置(upright)<0.08<0.08<0.092.54<0.13
倒置(upend)<0.08<0.08<0.093.31<0.13
181130121正置(upright)<0.08<0.08<0.092.74<0.13
倒置(upend)<0.08<0.08<0.092.64<0.13
6181128121正置(upright)<0.08<0.08<0.092.86<0.13
倒置(upend)<0.08<0.08<0.093.36<0.13
181129121正置(upright)<0.08<0.08<0.092.47<0.13
倒置(upend)<0.08<0.08<0.093.35<0.13
181130121正置(upright)<0.08<0.08<0.092.92<0.13
倒置(upend)<0.08<0.08<0.093.59<0.13
), ArticleFig(id=1239173827528283117, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, language=EN, label=Tab.5, caption=

Safety assessment of drug migration

, figureFileSmall=null, figureFileBig=null, tableContent=
化合物
（compound）		最大检出量
（maximum amount detected）/(μg·mL-1)		每日最大摄入量
（maximum daily intake）/（μg·d-1)		PDE/（μg·d-1)安全
（safe）
BHT-OH<0.08<8021 000是（yes）
BHT-COOH<0.08<80500是（yes）
BHT-Q<0.09<90500是（yes）
BHT3.593 5901 800否（no）
可提取硫（extractable sulfur）<0.13<1302 000是（yes）
), ArticleFig(id=1239173827645723636, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173817705222749, language=CN, label=表5, caption=

药品迁移安全性评估

, figureFileSmall=null, figureFileBig=null, tableContent=
化合物
（compound）		最大检出量
（maximum amount detected）/(μg·mL-1)		每日最大摄入量
（maximum daily intake）/（μg·d-1)		PDE/（μg·d-1)安全
（safe）
BHT-OH<0.08<8021 000是（yes）
BHT-COOH<0.08<80500是（yes）
BHT-Q<0.09<90500是（yes）
BHT3.593 5901 800否（no）
可提取硫（extractable sulfur）<0.13<1302 000是（yes）
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HPLC法测定药用胶塞中常用抗氧剂及可提取硫向丙泊酚中/长链脂肪乳注射液中的迁移
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成婕 1 , 江燕 1 , 邱怡婷 1 , 任锟 1 , 赵津池 2 , 田甜 1 , 张罗红 1, *
药物分析杂志 | 安全监测 2024,44(2): 307-315
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药物分析杂志 | 安全监测 2024, 44(2): 307-315
HPLC法测定药用胶塞中常用抗氧剂及可提取硫向丙泊酚中/长链脂肪乳注射液中的迁移
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成婕1 , 江燕1, 邱怡婷1, 任锟1, 赵津池2, 田甜1, 张罗红1, *
作者信息
  • 1.四川省药品检验研究院，成都 610097
  • 2.成都康华生物制品股份有限公司，成都 610199

    • Tel：15828617937；E-mail：

通讯作者:

*Tel：13808004672；E-mail：
Determination of migration of common antioxidants and extractable sulfur in medical rubber stoppers to propofol medium/long chain fat emulsion injection by HPLC
Jie CHENG1 , Yan JIANG1, Yi-ting QIU1, Kun REN1, Jin-chi ZHAO2, Tian TIAN1, Luo-hong ZHANG1, *
Affiliations
  • 1.Sichuan Institute for Drug Control, Chengdu 610097, China
  • 2.Chengdu Kanghua Biological Products Company Limited, Chengdu 610199, China
出版时间: 2024-02-29 doi: 10.16155/j.0254-1793.2024.02.14
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摘要
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目的：

建立一种高效液相色谱方法（HPLC），用于考察药用胶塞中常用抗氧剂及可提取硫的提取情况，以及药用胶塞中抗氧剂及可提取硫向丙泊酚中/长链脂肪乳注射液的迁移情况。

方法：

采用Waters Symmetry RP18（250 mm×4.6 mm，5 μm）色谱柱，流动相为甲醇-乙腈-1%醋酸水溶液，梯度洗脱，检测波长为277 nm，流速为1 mL·min-1，柱温为35 ℃。

结果：

各组分分离度良好；在0.1~20 μg·mL-1范围内线性关系良好，r≥0.999 6；该方法的精密度、稳定性、重复性均良好，RSD均<5.0%；回收率为93.3%~108.7%，RSD为1.8%~12.5%。检出3批药液中均有抗氧剂BHT的迁移，且含量高于其相应人每日允许最大暴露量（PDE）值，有较大安全性风险。

结论：

该方法具有较高的灵敏度，操作简便，能够用于检测丙泊酚中/长链脂肪乳注射液中抗氧剂的迁移。

高效液相色谱法  /  丙泊酚中/长链脂肪乳注射液  /  抗氧剂  /  可提取硫
Objective:

To establish a high-performance liquid chromatography (HPLC) method for investigating the extraction of common antioxidants and extractable sulfur in medical rubber stoppers and the migration of antioxidants and extractable sulfur to propofol medium/long chain fat emulsion injection.

Methods:

Waters Symmetry RP18(250 mm×4.6 mm，5 μm) was used as chromatographic column with methanol-acetonitrile -1% acetic acid solution as the mobile phase. Detection wavelength, velocity of flow and column temperature were set to 277 nm, 1 mL·min-1 and 35 ℃.

Results:

Good resolution and linear relationship (r≥0.999 6) in the range of 0.1-20 μg·mL-1 were achieved. This method possesses superior precision, stability, repeatability, and all RSD were less than 5%. The rate of recovery was 93.3%-108.7%, and the RSD was 1.8%-12.5%. The migration of antioxidant BHT was detected in three batches of solution and the content was higher than its corresponding permitted daily exposure (PDE) value, which means there is a large safetyrisk.

Conclusion:

The method represents high sensitivity and is easy to operate, which can effectively detect the migration of antioxidants in propofol medium/long chain fat emulsion injection.

high-performance liquid chromatography (HPLC)  /  propofol medium and long chain fat emulsion injection  /  antioxidants  /  extractable sulfur
成婕, 江燕, 邱怡婷, 任锟, 赵津池, 田甜, 张罗红. HPLC法测定药用胶塞中常用抗氧剂及可提取硫向丙泊酚中/长链脂肪乳注射液中的迁移. 药物分析杂志, 2024 , 44 (2) : 307 -315 . DOI: 10.16155/j.0254-1793.2024.02.14
Jie CHENG, Yan JIANG, Yi-ting QIU, Kun REN, Jin-chi ZHAO, Tian TIAN, Luo-hong ZHANG. Determination of migration of common antioxidants and extractable sulfur in medical rubber stoppers to propofol medium/long chain fat emulsion injection by HPLC[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (2) : 307 -315 . DOI: 10.16155/j.0254-1793.2024.02.14
正文
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丙泊酚中/长链脂肪乳注射液主要应用于手术期的麻醉诱导、麻醉维持以及成年患者诊断和手术操作的镇静，具有起效快、清除迅速、不良反应少等特点[1-2]。该注射液使用药用卤化丁基橡胶塞为密封件，这类胶塞因具有吸湿率低、耐化学性、气密性好、无生理毒副作用等优势而被药品生产企业广泛使用[3-5]。药用胶塞在生产过程中会添加抗氧剂与硫化剂：抗氧剂的加入能防止在加工和使用过程中橡胶老化，目前药用胶塞中常用抗氧剂主要有BHT、1076、1010、330、3114、168，这些抗氧剂在加工使用过程中可能会发生降解，其中BHT可能降解为BHT-OH、BHT-COOH、BHT-CHO、BHT-Q，1010、1076可能降解为1310，168可能降解为2，4-DBP；硫化剂的加入能增强胶塞的物理和化学性能，目前常用的硫化剂主要是可提取硫[6]。这些添加剂在与药品接触过程中，可能会迁移至药品中，影响药品质量，危害人体健康。国家药品监督管理局发布的《化学药品与弹性体密封件相容性研究技术指导原则》（试行）指出，弹性体密封件既要满足对包装系统密封性的要求，又要满足密封件与药品具有良好相容性的要求，不可引入具有安全性风险的浸出物，以保证药品在整个生命周期的安全性[7]。本文参考相关文献[8-15]，建立HPLC法同时考察药用胶塞中多种常用抗氧剂和可提取硫的提取情况，以及药用胶塞中抗氧剂和可提取硫向丙泊酚中/长链脂肪乳注射液的迁移情况，为其他注射用制剂及其相应药用胶塞的提取与迁移试验提供参考。
1　仪器与试药
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1.1　仪器
LC-20A型高效液相色谱仪，岛津公司；XS205DU十万分之一型电子天平，Sartorius公司；AL-204-IC万分之一型电子天平，Sartorius公司；AS5150A型超声仪，天津奥特赛恩斯仪器有限公司；AS5150A型微波消解仪，CEM公司。
1.2　试药
抗氧剂2，6-二叔丁基-4-羟甲基苯酚（BHT-OH）（批号C0006419，含量97.8%），Beijing Manhage Bio-Tech公司；抗氧剂3，5-二叔丁基-4-羟基苯甲酸（BHT-COOH）（批号U11B056，含量98%），Alfa Aesar公司；抗氧剂3，5-二叔丁基-4-羟基苯基丙酸（1310）（批号C0006441，含量99.4%），BePure公司；抗氧剂3，5-二叔丁基-4-羟基苯甲醛（BHT-CHO）（批号P1193047，含量98%），Adamas Reagent公司；抗氧剂2，6-二叔丁基苯醌（BHT-Q）（批号P1033037，含量97%），Adamas Reagent公司；抗氧剂2，4-二叔丁基苯酚（2，4-DBP）（批号HGM01-NESL，含量97%），梯希爱（上海）化成工业发展有限公司；抗氧剂2，6-二叔丁基对甲基苯酚（BHT）（批号W2640010，含量98%），Anpel公司；抗氧剂三(3，5-二叔丁基-4-羟苄基)异氰脲酸酯（3114）（批号C0006440，含量99.7%），BePure公司；抗氧剂四(3，5-二叔丁基-4-羟基)苯丙酸季戊四醇酯（1010）（批号11725DE，含量98%），Sigma-Aldrich公司；抗氧剂1，3，5-三甲基-2，4，6-三(3，5-二叔丁基-4-羟基苄基)苯（330）（批号C0006361，含量99.5%），Be Pure公司；抗氧剂β-（3，5-二叔丁基-4-羟基苯基）丙酸正十八碳醇酯（1076）（批号C0006444，含量98.8%），Be Pure公司；抗氧剂三(2，4-二叔丁基苯基)亚磷酸酯（168）（批号EW3HC-LC，含量98%），TCI公司；可提取硫（批号P1369618，含量99.9%），Damas-beta公司。
甲醇、乙腈、四氢呋喃均为色谱纯，Fisher公司；乙酸为色谱纯，CNW Technologies公司。1%丙泊酚中/长链脂肪乳注射液（A厂，规格50 mL：0.5 g，批号181128121、181129121、181130121），注射液用卤化丁基橡胶塞（氯化）（B厂，批号S180711201）。
2　方法与结果
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2.1　色谱条件
采用SymmetryShield RP18（250 mm×4.6 mm，5 μm）色谱柱，流动相乙腈(A)-甲醇(B)-1%醋酸水溶液(C)，梯度洗脱（0~6 min，10%A，50%B，40%C；6~9 min，20%A，50%B，30%C；9~12 min，25%A，50%B，25%C；12~21 min，5%A，80%B，15%C；21~24 min，90%A，5%B，5%C；24~38 min，0%A，98%B，2%C；38~50 min，10%A，50%B，40%C），流速1.0 mL·min-1，柱温35 ℃，检测波长277 nm，进样量10 μL。
2.2　溶液的制备
2.2.1　对照品储备液
分别取对照品BHT-OH、BHT-COOH、BHT-CHO、BHT-Q、2，4-DBP、BHT、3114、1010、330、1076、1310、168及可提取硫约50 mg，精密称定，分别置50 mL量瓶中，加二氯甲烷约5 mL溶解，用甲醇定容，摇匀，配制成质量浓度约为1 000 μg·mL-1的单一成分对照品溶液。分别取上述单一成分对照品溶液10 mL，置100 mL量瓶中，用甲醇定容，配制成质量浓度约为100 μg·mL-1的混合对照品储备液A，备用；再分别取BHT-OH、BHT-COOH、BHT-Q、BHT及可提取硫的单一成分对照品溶液1 mL，置25 mL量瓶中，用甲醇定容，配制成质量浓度约为40 μg·mL-1的混合对照品储备液B，备用。
2.2.2　提取试验供试品溶液
将注射液用卤化丁基橡胶塞（氯化）剪碎成约5 mm×5 mm的小颗粒，称取约2.0 g，装入微波消解罐中，加入二氯甲烷10 mL，40 ℃微波提取45 min，冷却至室温。用玻璃漏斗过滤，除去胶塞，将滤液旋蒸，除去二氯甲烷。挥干后的残渣用5 mL甲醇超声（频率40 kHz/功率70 W）溶解，转移溶解液至10 mL量瓶中，甲醇定容，即得。
2.2.3　药品迁移供试品溶液
分别取1%丙泊酚中/长链脂肪乳注射液（批号181128121、181129121、181130121）样品各1瓶，分别取药液2 mL至10 mL量瓶中，四氢呋喃定容至刻度，混匀，即得。
2.2.4　回收率试验溶液
取丙泊酚中/长链脂肪乳注射液（批号181128121）2瓶，混匀，精密量取混匀后的药液2 mL共9份，分为3组，分别置于10 mL量瓶中，每组分别加入混合对照品储备液B 0.25、0.5、1.25 mL，四氢呋喃定容至刻度，制成含对照品质量浓度约为1、2、5 μg·mL-1的供试溶液。
2.3　系统适应性试验
取“2.2.1”项下混合对照品储备液A，用甲醇稀释5倍，在本文色谱条件下进样测定，各化合物峰之间分离良好，分离度均>1.5，理论塔板数均>5 000。色谱图见图1。
2.4　线性关系考察
精密量取“2.2.1”项下混合对照品储备液A 0.05、0.25、0.5、2.5、5、10 mL，分别置于50 mL量瓶中，甲醇稀释至刻度，制成13种抗氧剂系列浓度对照品溶液。精密量取上述系列浓度溶液各10 μL，按“2.1”项下色谱条件进样分析，记录峰面积。以待测成分质量浓度X（μg·mL-1）为横坐标，峰面积Y为纵坐标，进行线性回归，结果见表1。
2.5　检测限与定量限考察
取“2.2.1”项下混合对照品储备液A适量，用甲醇依次稀释，按“2.1”项下色谱条件进样分析，以信噪比（S/N）为3时的浓度作为检测限，以信噪比（S/N）为10时的浓度作为定量限。提取试验与迁移试验的检测限和定量限，需根据胶塞提取与药品迁移制样的稀释倍比进行计算，具体稀释过程见“2.2.2”“2.2.3”项下，结果见表1。
2.6　胶塞提取试验
取“2.2.2”项下胶塞提取试验供试溶液，按“2.1”项下色谱条件进样分析，检测胶塞中上述抗氧剂及可提取硫的含量，结果见表2。该胶塞中检出抗氧剂BHT及可提取硫，其余化合物均未检出。抗氧剂BHT每日最大摄入量计算值高于其相应人每日允许最大暴露量(PDE)值，其余化合物每日最大摄入量计算值均低于其相应PDE值。本文拟在迁移试验中进一步考察抗氧剂BHT及检出量较高的可提取硫，以进一步评估其风险。
2.7　药品迁移试验
根据“2.5”项下胶塞提取试验结果，本次迁移试验主要针对提取试验中风险较高的抗氧剂BHT及可提取硫。由于抗氧剂BHT在迁移过程中可能降解为BHT-OH、BHT-COOH、BHT-Q，基于风险考虑，本次迁移试验需对BHT-OH、BHT-COOH、BHT-Q做进一步考察。
2.7.1　精密度试验
取“2.2.1”项下混合对照品储备液B适量，按“2.1”项下色谱条件进样分析，连续进样6次，记录峰面积。结果抗氧剂BHT、BHT-OH、BHT-COOH、BHT-Q及可提取硫峰面积的RSD（n=6）分别为0.79%、0.39%、0.28%、0.67%、0.36%，表明仪器稳定性良好。
2.7.2　稳定性试验
取“2.2.4”项下回收供试品溶液，分别于室温下放置0、4、9、16、21、28 h，按“2.1”项下色谱条件进样分析，记录峰面积。结果抗氧剂BHT、BHT-OH、BHT-COOH、BHT-Q及可提取硫峰面积的RSD（n=6）分别为1.5%、0.93%、3.4%、1.1%、4.8%，表明供试品溶液在室温下放置28 h内稳定。
2.7.3　重复性试验
药品供试溶液中检出抗氧剂BHT，质量浓度约为0.3 μg·mL-1，未检出BHT-OH、BHT-COOH、BHT-Q及可提取硫。为了更准确地验证该方法的重复性，需加入混合对照品储备液B，照“2.2.4”项下方法，同法制备6份对照品浓度为5 μg·mL-1的供试溶液，按“2.1”项下色谱条件进样分析，结果抗氧剂BHT、BHT-OH、BHT-COOH、BHT-Q及可提取硫的含量均约为5 μg·mL-1，RSD（n=6）分别为2.7%、2.6%、3.0%、2.3%、2.4%，表明该方法有良好重复性。
2.7.4　回收率试验
取“2.2.4”项下回收供试品溶液，按“2.1”项下色谱条件进样分析，结果见表3，回收率为93.3%~108.7%，RSD为1.8%~12.5%，表明该方法测定丙泊酚中/长链脂肪乳注射液供试品中抗氧剂准确度良好。
2.7.5　丙泊酚中/长链脂肪乳注射液药品中迁移量测定
根据提取试验结果，考察在温度40 ℃±2 ℃、相对湿度75%±5%的加速条件下放置0月（正置）、3月（正置、倒置）、6月（正置、倒置）后，药品中上述抗氧剂及可提取硫的迁移情况。照“2.2.3”项下方法制备供试品溶液，按“2.1”项下色谱条件进样分析，结果见表4。加速0、3、6月的样品中均迁移出抗氧剂BHT，迁移量为1.79~3.59 μg·mL-1；BHT迁移量随着加速时间的增加而增加，倒置样品迁移量高于正置；均未检出抗氧剂BHT-OH、BHT-COOH、BHT-Q及可提取硫。
3　讨论
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3.1　抗氧剂及可提取硫的PDE值
文献[16]报道抗氧剂1010、330、3114的PDE值分别为10、5、25 mg·d-1；文献[17]报道抗氧剂BHT-OH、BHT-CHO、BHT、2，4-DBP、1 076、168的PDE值分别为21、0.5、1.8、0.24、0.768、9.5 mg·d-1。
对于未获得毒性数据的化合物，可参考结构类似物推测其PDE值[16]。抗氧剂BHT-COOH、BHT-Q均参考BHT-CHO的PDE值0.5 mg·d-1；抗氧剂1310参考1076的PDE值0.768 mg·d-1。
根据欧洲化学物质数据集（IUCLID）的记载，可提取硫的未观察到损害作用剂量（NOAEL）为500 mg·kg-1·d-1，兔与人的换算系数（F1）取2.5，不同人体的差异系数（F2）取10，对啮啃动物家兔3个月研究换算系数（F3）取5，因未发现严重的毒性系数（F4）取1，因不产生反应的量测得系数（F5）取1，口服与注射的换算系数取100，成人体质量以50 kg计，可提取硫的PDE（注射途径）=500 mg·kg-1·d-1×50 kg×(2.5×10×5×1×1)-1×100-1=2 mg·d-1。
3.2　药品中抗氧剂及可提取硫的安全性评估
根据生产厂家提供的资料，1%丙泊酚中/长链脂肪乳注射液（规格50 mL：0.5 g）每日最大使用量为20瓶，以药品检出的最大量计算患者每日最大摄入量，将其与相应抗氧剂PDE值比较，以评估药品迁移的安全性风险。结果（表5）表明，抗氧剂BHT-OH、BHT-COOH、BHT-Q及可提取硫每日最大摄入量均小于其相应的PDE值，由胶塞迁移至药品的风险较低。抗氧剂BHT每日最大摄入量为3 590 μg·d-1，远高于其PDE值（1 800 μg·d-1），由胶塞迁移至药品的风险较高，药液注射入患者体内后可能会带来较大的安全性风险。基于风险考虑，该生产企业已停止使用注射液用卤化丁基橡胶塞（氯化）作为丙泊酚中/长链脂肪乳注射液的密封件，更换为覆膜药用胶塞（注射液用覆聚全氟乙丙烯膜溴化丁基橡胶塞）后再次验证，上述抗氧剂均未检出。究其原因，是由于覆膜药用胶塞（注射液用覆聚全氟乙丙烯膜溴化丁基橡胶塞）的膜层完全覆盖与药液接触的胶塞部位，药液并未直接接触胶塞，抗氧剂不易从该种胶塞中迁移至药液。
3.3　提取溶剂的选择
由于丙泊酚中/长链脂肪乳注射液具有较好的脂溶性，为了更好地模拟药液性质，本文选用二氯甲烷作为提取溶剂，采用高效的微波萃取作为胶塞的提取方式。该方法使用较为极端的条件提取胶塞中抗氧剂及可提取硫，得到的可提取物更多，更有利于抗氧剂及可提取硫的筛查。
3.4　药品迁移方法的选择
由于目标化合在丙泊酚中/长链脂肪乳注射液中溶解性较好，选用溶剂萃取的方法很难把药液中的抗氧剂完全提取出来，因此选用溶剂直接溶解稀释的方法。经比较，四氢呋喃在一定比例下能够很好地溶解该药品。四氢呋喃与药液体积比为1∶1、2∶1、3∶1、4∶1时，四氢呋喃均未能完全溶解药液；调整体积比为5∶1时，药液被四氢呋喃完全溶解。因此，选用溶剂四氢呋喃直接溶解稀释药品的方法，稀释体积比为5∶1。
3.5　色谱柱的选择
试验采用①Symmetry C8（250 mm×4.6 mm，5 μm）、②ZORABX Eclipse C18（150 mm×4.6 mm，5 μm）、③Gemini 110 C18（250 mm×4.6 mm，5 μm）、④SymmetryShield RP18（250 mm×4.6 mm，5 μm）4种色谱柱对上述13个化合物进行分离。结果发现：采用色谱柱①不能完全分离这13个化合物；采用色谱柱②，部分化合物如BHT-COOH、可提取硫、1330拖尾现象比较严重且各化合物分离度较差；采用色谱柱④、③，均能使上述13个化合物达到基线分离，但前者获得目标化合物色谱峰的峰形明显优于后者，因此，选择色谱柱④进行分析。
3.6　检测波长的选择
考察化合物的紫外吸收波长发现，250~290 nm范围内各化合物均能找到最大吸收波长，为兼顾各化合物的响应与灵敏度，选择277 nm作为检测波长。
3.7　流动相的选择
为确保所有化合物均可达到良好分离，本研究选择梯度洗脱。查阅文献发现，多数文章使用的流动相体系为甲醇-水，而本次重点研究的抗氧剂及可提取硫，使用该体系作为流动相时，各组分的分离度较差，拖尾峰较多，而且基线不平稳。经过多次筛选与比较，发现甲醇-乙腈-1%醋酸水溶液作为流动相体系时，各组分的保留时间适中，分离度良好，基线更平稳，满足系统适用性试验要求。
4　结论
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本文开发了1种监测常用抗氧剂及可提取硫的HPLC方法，灵敏度高，操作简单，可同时用于丙泊酚中/长链脂肪乳注射液所用胶塞的提取试验与药品迁移试验。
文献
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2024年第44卷第2期
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doi: 10.16155/j.0254-1793.2024.02.14
  • 首发时间：2026-03-13
  • 出版时间：2024-02-29
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  • 修回日期：2023-09-20
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    1.四川省药品检验研究院，成都 610097
    2.成都康华生物制品股份有限公司，成都 610199

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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
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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