Gammelgaard B, Sandberg E
Royal Danish School of Pharmacy, Dept. of Chemistry AD, Copenhagen, Denmark.
J Trace Elem Electrolytes Health Dis. 1989 Mar;3(1):39-42.
Five different brands of commercially available human albumin solutions for infusion were analysed for their aluminium and nickel contents by atomic absorption spectrometry. The aluminium concentrations ranged from 12 micrograms/l to 1109 micrograms/l and the nickel concentrations ranged from 17 micrograms/l to 77 micrograms/l. Examination of the aluminium and nickel contents of the constituents for the production of one brand showed too low levels to explain the final contamination of the product. By following the aluminium and nickel concentrations of the same brand during the production of a batch of albumin solution, filtration was shown to contribute to contamination, although the largest increase in aluminium as well as nickel concentrations appeared during the bulk concentrating process. To avoid health risks to certain patients, regulations should be established requiring aluminium and nickel contamination to be as low as possible.
采用原子吸收光谱法对5种市售人血白蛋白输液制剂的铝和镍含量进行了分析。铝浓度范围为12微克/升至1109微克/升，镍浓度范围为17微克/升至77微克/升。对某一品牌产品生产所用成分的铝和镍含量检测显示，其含量过低，无法解释产品最终的污染情况。在一批白蛋白溶液生产过程中，跟踪同一品牌产品的铝和镍浓度发现，过滤过程会导致污染，尽管在浓缩过程中铝和镍浓度的增幅最大。为避免给某些患者带来健康风险，应制定相关规定，要求铝和镍污染尽可能低。
