Influence of the glass packing on the contamination of pharmaceutical products by aluminium. Part III: Interaction container-chemicals during the heating for sterilisation
Influence of the glass packing on the contamination of pharmaceutical products by aluminium. Part III: Interaction container-chemicals during the heating for sterilisation
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DOI：
10.1016/s0946-672x(03)80006-8
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发表时间：
2003-01-01
影响因子：
3.5
通讯作者：
Becker, E
中科院分区：
文献类型：
--
作者：
Bohrer, D;do Nascimento, PC;Becker, E
研究了加热灭菌过程中化学品与容器材料的相互作用，将肠外营养溶液的组分单独储存在密封的玻璃安瓿中并与橡胶塞接触，并在121 ℃下加热系统30 min。随后，通过原子吸收光谱法（AAS）测量溶液的铝含量。还用酸、碱和一些络合剂对铝进行了测定。将容器分解并测定铝。30种不同的市售胃肠外溶液。对储存在玻璃或塑料容器中的营养物进行分析，测量溶液和容器材料中存在的铝。所有研究的容器材料的结果显示，玻璃中的铝含量为1.57%，塑料中的铝含量为0.05%，橡胶中的铝含量为4.54%。灭菌程序表明，即使是纯水也能够从玻璃和橡胶中浸提铝，分别为22.5 +/-13.3 mug/L和79.4 +/-22.7 mug/L，从塑料中浸提的铝为白色，可忽略不计。从玻璃安瓿中释放的铝介于20 μ g/L（亮氨酸、鸟氨酸和赖氨酸溶液）和1500 pg/L（碱性磷酸盐和碳酸氢盐溶液）之间;从橡胶塞中释放的铝水平超过500 pg/L（半胱氨酸、天冬氨酸、谷氨酸和胱氨酸溶液）。离子交换性质和pH值的影响可以解释玻璃与某些化学品（盐、酸和碱）的相互作用，但考虑到铝的释放，只有对铝的亲和力才能解释某些氨基酸和其他化学品（如白蛋白和肝素）对玻璃和橡胶的作用。使用用于At的络合剂的实验可以得出结论，络合物的稳定常数越高，从容器材料释放的Al越高。
The interaction of chemicals with the container materials during heating for sterilisation was investigated, storing the components of parenteral nutrition solutions individually in sealed glass ampoules and in contact with a rubber stopper, and heating the system at 121 degreesC for 30 min. Subsequently, the aluminium content of the solutions was measured by atomic absorption spectrometry (AAS). The assay was also carried out with acids, alkalis and some complexing agents for Al. The containers were decomposed and also assayed for aluminium. 30 different commercial solutions for parenteral. nutrition, stored either in glass or in plastic containers, were assayed measuring the aluminium present in the solutions and in the container materials. The results of all investigated container materials revealed an aluminium content of 1.57% At in glass, 0.05% in plastic and 4.54% in rubber. The sterilisation procedure showed that even pure water was able to extract Al from glass and rubber, 22.5 +/- 13.3 mug/L and 79.4 +/- 22.7 mug/L respectively, white from plastic the aluminium Leached was insignificant. The Al released from glass ampoules laid between 20 mug/L for Leucine, ornithine and lysine solutions and 1500 pg/L for solutions of basic phosphates and bicarbonate; from rubber stoppers it reached levels over 500 pg/L for cysteine, aspartic acid, glutamic acid and cystine solutions. Ion-exchange properties and influence of pH can explain the interaction of glass with some chemicals (salts, acids and alkalis), but only an affinity for aluminium could explain the action of some amino acids and other chemicals, as albumin and heparin, on glass and rubber, considering the aluminium release. Experiments with complexing agents for At allowed to conclude that the higher the stability constant of the complex, the higher the Al release from the container material.