注射用卤化丁基橡胶塞中19种元素分析及研究

Analysis and research of 19 elements in halogenated butyl stopper for injection

关键词:  卤化丁基橡胶塞  电感耦合等离子体质谱法  元素分析

Key words:  halogenated butyl stopper  ICP-MS  elemental analysis

摘要:

目的 建立ICP-MS法测定注射用卤化丁基橡胶塞化学性能试验溶液中19种金属元素，并根据各元素分布情况对胶塞质量进行评价。方法 采用 ICP-MS法建立注射用卤化丁基橡胶塞化学性能试验溶液中锂（6Li）、硼（11B）、镁（24Mg）、铝（27Al）、钒（51V）、铬（52Cr）、钴（59Co）、镍（60Ni）、铜（63Cu）、锌（66Zn）、砷（75As）、钼（95Mo）、镉（111Cd）、锡（118Sn）、锑（121Sb）、钡（137Ba）、钨（183W）、汞（201Hg）、铅（208Pb）共19种元素同时测定的方法，考察各元素分布情况，修订质量标准，有效保证胶塞质量，从而提高药品包装材料质量控制水平。结果 测定方法中所有元素的线性相关系数（r）都大于0.9990，检出限在0.0001~5.000 μg·L-1之间，重复性和稳定性的相对标准偏差（RSD）都小于10%，加标回收率在90%~120%之间。结论 ICP-MS法可准确同时测定注射用卤化丁基橡胶塞化学性能试验溶液中19种元素含量，为卤化丁基橡胶塞国家标准提高提供参考，为卤化丁基橡胶塞的风险监测提供科学实验基础。

Abstract:

OBJECTIVE To establish an inductively coupled plasma mass spectrometry (ICP-MS) method for the determination of 19 elements in dissolution test of halogenated butyl stopper and to evaluate the safety risk of the drug according to the content of each element. METHODS Simultaneous determination of lithium (6Li), boron (11B), aluminum (27Al), vanadium (51V), Chromium (52Cr), Cobalt (59Co), Nickel (60Ni), copper (63Cu), arsenic (75As), Molybdenum (95Mo), cadmium (111Cd), tin (118Sn),antimony (121Sb), barium (137Ba), tungsten (183W), mercury (201Hg), lead (208Pb) in dissolution test of halogenated butyl stopper was analyzed by ICP-MS. According to the distribution of each element, establish a reasonable limit of standards to effectively ensure the quality of halogenated butyl stopper, so as to improve the quality control level of pharmaceutical packaging materials. RESULTS: The linear correlation coefficients (r) of all elements in the method were greater than 0.9990, the detection limits were between 0.0001 ~5.000 μg·L-1, the relative standard deviations (RSD) of repeatability and stability were all less than 10%, and the spiked recoveries were 90% ~ 120%. CONCLUSION The method can accurately and simultaneously determine the content of 19 elements in the dissolution test of halogenated butyl stopper by ICP-MS, providing reference for improving the national standard of halogenated butyl stopper and scientific experimental basis for risk monitoring of halogenated butylr stopper.