ICP-MS法测定五层共挤输液用袋中8种元素在碳酸氢钠林格注射液中的迁移量  

Determination of Migration of Eight Elements from Five-layer Co-extrusion Bags in Bicarbonated Ringer′s Injection by ICP-MS

作　　者：杨文宇 李飞 兰婉玲 赵代国 李勇 张加宇 赖朋 李玉锋 YANG Wen-yu;LI Fei;LAN Wan-ling;ZHAO Dai-guo;LI Yong;ZHANG Jia-yu;LAI Peng;LI Yu-feng(School of Food and Bioengineering,Xihua University,Chengdu 610039,China;Sichuan Institute for Food and Drug Control,Chengdu 611731,China;Sichuan Pacific Pharmaceutical Co.,Ltd,Chengdu 611731,China)

机构地区：[1]西华大学食品与生物工程学院,四川成都610039 [2]四川省食品药品检验检测院,四川成都611731 [3]四川太平洋药业有限责任公司,四川成都611731

出　　处：《海峡药学》2020年第11期47-52,共6页Strait Pharmaceutical Journal

基　　金：四川省经信委创新能力提升-创新平台建设项目“负压式软袋输液组合袋”(No.2016NL015)。

摘　　要：目的考察五层共挤输液用袋中锂、铝、铬、铜、砷、镉、锡、铅8种元素在碳酸氢钠林格注射液中的迁移情况。方法采用电感耦合等离子体质谱法,先对模拟试验溶液进行半定量分析以确定待测金属元素,再对样品溶液中各元素含量进行测定。射频功率为1550 W,载气流量为1.01 L·min-1,雾化泵转数0.1 r·s-1,雾化室温度为2℃,采样深度为8 mm,采样锥类型为Ni,采样锥孔径为1mm,采样间隔为105 s,重复次数为3次,积分时间为0.1 s。结果样品在加速试验条件下〔温度:(40±2)℃、相对湿度:75%±5%〕储存0、3、6个月后样品溶液中锂、铝、铬、铜、砷、镉、锡、铅的最大迁移量分别为<0.02、3.62、1.88、<0.09、<0.05、<0.02、2.22、<0.03μg/袋。结论五层共挤输液用袋中的锂、铝、铬、铜、砷、镉、锡、铅在碳酸氢钠林格注射液中的迁移量均符合有关规定。OBJECTIVE To investigate 8 kinds of inorganic elements(Li,Al,Cr,Cu,As,Cd,Sn and Pb)in Bicarbonated Ringer′s Injection migrated from its packaging materials,five-layer co-extrusion infusion bags.METHODS ICP-MS method was used.Firstly,conducting semi-quantitative analysis of simulation test solution to clarify which elements to be quantitatived,then determining the content of each inorganic element in the sample solution.Parameters of experimental conditions were as follows:the RF power was 1550W,the carrier gas velocity was 1.01L·min-1,the peristaltic pump rate was 0.1r·s-1,the atomizing chamber temperature was 2℃,the sampling depth was 8mm,the sampling cone type was Ni,the sampling cone diameter was 1mm,the sampling interval was 105s,the repetition was 3 times,the integration time was 0.1s.RESULTS Under the accelerated test conditions〔(temperature:(40±2)℃and relative humidity:75%±5%)〕,the maximum migration of Li,Al,Cr,Cu,As,Cd,Sn and Pb in the sample solution after storage for 0,3 and 6 months were<0.02,3.62,1.88,<0.09,<0.05,<0.02,2.22 and<0.03μg per bag respectively.CONCLUSION The migration of Li,Al,Cr,Cu,As,Cd,Sn and Pb in the Bicarbonated Ringer′s Injection from the five-layer co-extrusion infusion bags are all in line with related standards.

关 键 词：电感耦合等离子体质谱法 碳酸氢钠林格注射液 五层共挤输液用袋 有害元素 迁移量 

分 类 号：R927[医药卫生—药学]