ICP-MS标准加入法考察复方氨基酸注射液中铝元素残留量

目的: 建立电感耦合等离子体质谱(ICP-MS)法测定复方氨基酸注射液中铝的残留量.方法: 样品用1%硝酸直接稀释,以铟为内标,选择标准加入法定量以消除基体效应和干扰.结果: Al(铝)浓度在0~500.0 μg·L^-1范围内呈良好的线性关系(r=0.9999);平均回收率为98.9%,RSD为0.77%.5个氨基酸注射液样品中铝残留量为20.20~110.6 μg·L^-1.结论: 该方法简便、快速、准确,可用于复方氨基酸注射液中Al(铝)的残留量.不同生产企业的氨基酸注射液中铝残留量存在很大差异,有必要控制复方氨基酸注射液铝的残留量.

Objective: To establish an ICP-MS method for the determination of residual aluminum in compound amino acid injections. Methods: Samples were directly diluted with 1% nitric acid with ¹¹⁵In as an internal standard and were quantitated by the standard addition method to eliminate matrix effects and interference. Results: The response of aluminum showed good linearity (r=0.9999) in the range of 0-500.0 μg·L^-1; the average recovery was 98.9% with RSD of 0.77%. The aluminum residue was 20.20-110.6 μg·L^-1 in 5 samples of compound amino acid injections. Conclusion: The method is simple, rapid, accurate, and can be used for determination of aluminum in compound amino acid injections. There is a significant difference in residues of aluminum between compound amino acid injections from different manufacturers, and it is necessary to control the residues of aluminum in compound amino acid injections.

[1] Moore PB,Day JP,Taylor GA,et al. Absorption of aluminium²⁶ in Alzheimer’s disease, measured using accelerator mass spectrometry[J]. Dement Geriatr Cogn Disord, 2000, 11(2): 66
[2] Campbell A,Hamai D,Bondy SC. Differential toxicity of aluminum salts in human cell lines of neural origin:implications for neurodegener ation[J]. Neurotoxicology, 2001, 22(1): 63
[3] HUANG Guo-wei(黄国伟),KANG Jing(康静),DONG Ya-li(董亚利),et al. The study of aluminum toxic effect on human embryonic osteoblasts in vitro(铝对体外培养人胚成骨细胞毒性作用的研究)[J]. China Public Health(中国公共卫生),2000,16(4):97
[4] ChP 2005.VolⅢ(中国药典2005年版.三部)[S].2005:164
[5] MA Dian-jun(马殿君),GAO Guang-hui(高广慧). Comparison of three aluminum assay methods for quantitative determination of sea cucumber products(3种铝分析方法在定量测定海参产品的比较)[J]. Chin J Spectrosc Lab(光谱实验室),2013,30(2):817
[6] XIAO Lin(肖林). Tracing research of residual aluminium content of human albumin products made in China(人血白蛋白制品铝残留量的追踪研究)[J]. Chin J Pharm Anal(药物分析杂志),2007,27(8):1218
[7] HAN Feng-chao(韩峰超),WANG Xiao-li(王晓黎),GAO Guang-hui(高广慧),et al. Determination of aluminum in amino acid compound injections(18) by GFAAS(石墨炉原子吸收标准加入法考察复方氨基酸注射液(18)中铝元素含量)[J]. Pract Pharm Clin Remed(实用药物与临床),2010,13(5):346
[8] LI Hao(李浩),ZHU Bin(朱斌),HUANG Bao-gui(黄宝贵). Determination of Al in citric acid by graphite furnace atomic absorption spectrometry(石墨炉原子吸收光谱法测定枸橼酸中的铝)[J]. Chin J Pharm Anal(药物分析杂志),2010,30(3):530
[9] SUN Mei(孙梅). Determination of trace-aluminium in human serum album by graphite furnace atomic absorption spectrometry(原子吸收光谱法测定人血白蛋白制剂中的痕量铝)[J]. Chin J Pharm Anal(药物分析杂志),2007,27(1):113
[10] LI Hai-xia(李海霞),ZHANG Fu-cheng(张福成),JIANG Ye(蒋晔). Dissolution of aluminium in zoledronic acid injection by graphite furnace atomic absorption spectrometry(石墨炉原子吸收光谱法对唑来膦酸注射剂中铝的溶蚀研究)[J]. Chin J Pharm Anal(药物分析杂志),2010,30(6):1048
[11] WANG Xiao-li(王晓黎),HAN Feng-chao(韩峰超), XIANG Tong-ling(相同玲)). Determination of aluminum in some large volume injections by ICP-MS(大容量注射液中铝离子浓度含量测定及评价)[J]. Drug Stand China(中国药品标准),2009,10(4):271
[12] HAN Feng-chao(韩峰超),SUN Xiao-juan(孙晓娟),DONG Yu(董宇),et al. Determination of aluminum in some injections by ICP-MS(电感耦合等离子体质谱法测定注射液中铝离子浓度)[J]. Pract Pharm Clin Remed(实用药物与临床),2010,13(3):195
[13] SHI Fang-liang(史芳亮),CHEN Gang(陈钢),CHEN Deng-yun(陈登云). ICP-MS fast determination of trace aluminium in human albumin(应用ICP-MS快速测定人血白蛋白中铝残留量)[J]. Chin J Pharm Anal(药物分析杂志),2008,28(10):1602
[14] HU Xiao-jing(胡晓静),MA Dian-jun(马殿君),GAO Guang-hui(高广慧). Determination of aluminum in sea cucumber capsule by ICP-MS(电感耦合等离子体质谱法测定海参胶囊中铝的分析方法)[J]. Chin J Health Lab Technol(中国卫生检验杂志),2014,24(4):503
[15] ChP 2010. VolⅡ(中国药典2010年版.二部)[S].2010:Appendix(附录)24