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期刊名称:药物分析杂志
主管单位:中国科学技术协会
主办单位:中国药学会
承办:中国食品药品检定研究院
主编:金少鸿
地址:北京天坛西里2号
邮政编码:100050
电话:010-67012819,67058427
电子邮箱:ywfx@nifdc.org.cn
国际标准刊号:ISSN 0254-1793
国内统一刊号:CN 11-2224/R
邮发代号:2-237
 

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ICP-MS法测定维生素B1注射液中硼、铝、砷、钡、铅的含量

Determination of B, Al, As, Ba and Pb in vitamin B1 injection by ICP-MS

分类号:
出版年·卷·期(页码):2016,36 (3):0-0
DOI: 10.16155/j.0254-1793.2017.01.01
-----摘要:-------------------------------------------------------------------------------------------

目的:建立同时测定维生素B1注射液中硼、铝、砷、钡、铅的方法。方法:采用电感耦合等离子体质谱法(ICP-MS)。仪器射频(RF)入射功率为1.3 kW,萃取电压为-143 V,采样深度为65 mm,冷却气流速为13.0 L·min-1,辅助气流速为0.81 L·min-1结果:该方法的加样回收率为95.9%~106.8%,RSD为0.5%~3.5%。被测样品中硼、铝和钡含量偏高。28批样品中硼元素含量为313.4~1028.0 ng·mL-1,铝元素含量为272.4~863.9 ng·mL-1,砷元素含量为0~31.0 ng·mL-1,钡元素含量为115.8~341.0 ng·mL-1,铅元素含量为3.0~87.8 ng·mL-1结论:本方法操作简便、结果可靠,可作为低硼硅玻璃与维生素B1注射液相容性研究检测方法。

-----英文摘要:---------------------------------------------------------------------------------------

Objective:To establish a method to determine B, Al, As, Ba and Pb in vitamin B1 injection, so as to control the quality of vitamin B1 injections.Methods:Vitamin B1 injections were determined simultaneously by ICP-MS.Incident power was 1.3 kW, the extraction voltage was-143 V, sample depth was 65 mm, the flow rate of plasma gas was 13.0 L·min-1, and the flow rate of auxiliary gas was 0.81 L·min-1.Results:The recovery rates of the method were in the range of 95.9%-106.8%, and the RSDs were in the range of 0.5%-3.5%.The analytical results indicated that the contents of B, Al and Ba were at a relatively high level in these samples.The determination results of 28 batches of samples showed that, the content of B was within 313.4-1028.0 ng·mL-1, the content of Al 272.4-863.9 ng·mL-1, the content of As 0-31.0 ng·mL-1, the content of Ba 115.8-341.0 ng·mL-1, and the content of Pb 3.0-87.8 ng·mL-1.Conclusion:The established method is proved to be accurate, simple and convenient, which provides a foundation for compatibility study between low borosilicate glass and vitamin B1 injection.

-----参考文献:---------------------------------------------------------------------------------------
[1] 周健丘,梅丹.药品包装材料对药品质量和安全性的影响[J].药物不良反应杂志,2011,13(1):27 ZHOU JQ,MEI D.Influence of pharmaceutical packaging materials on quality and safety of medicines[J].Adverse Drug React J,2011,13(1):27
[2] 潘云雪,陈成飞,金朦娜,等.ICP-MS测定明胶空心胶囊中铅、铬、镉、砷、铜的含量[J].中国现代应用药学,2014,31(3):339 PAN YX,CHEN CF,JIN MN,et al.Determination of Pb,Cr,Cd,As and Cu in vacant gelatin capsules by ICP-MS[J].Chin J Mod App l Pharm,2014,31(3):339
[3] 中国药典2010年版.三部[S].2010:212 ChP 2010.Vol Ⅲ[S].2010:212
[4] YBB00302002低硼硅玻璃管制注射剂瓶[S].2002 YBB00302002 Ampoules Made of Low Borosilicate Glass Tubing[S].2002
[5] USP38-NF33.Vol Ⅰ[S].2015:243
[6] International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.ICH Harmonised Guideline for Elemental Impurities:Q3D[EB/OL].Geneva:ICH,(2014)[2015-06-01].http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q3D/Q3D_Step_4.pdf
[7] 卢顺,彭克美,向敏,等.硼对动物的营养与毒性作用研究进展[J].动物医学进展,2014,35(2):78 LU S,PENG KM,XIANG M,et al.Advances in nutrition and toxic effect of B on the animal[J].Prog Vet Med,2014,35(2):78
[8] 王跃兵,黄文丽,李蕴成.微量元素钡与人体健康[J].地方病通报,2009,24(1):81 WANG YB,HUANG WL,LI YC.The trace element of Ba and human health[J].Endem Dis Bull,2009,24(1):81
[9] YBB00292005中性硼硅玻璃管制注射剂瓶[S].2002 YBB00292005 Ampoules Made of Borosilicate Glass Tubing[S].2002
[10] YBB00142002药品包装材料与药物相容性试验指导原则[S].2002 YBB00142002 Guidelines of Evaluating Compatibility between Pharmaceutical Packaging and Pharmaceuticals[S].2002

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