Melberg S G, Havelund S, Villumsen J, Brange J
Novo Research Institute, Bagsvaerd, Denmark.
Diabet Med. 1988 Apr;5(3):243-7. doi: 10.1111/j.1464-5491.1988.tb00977.x.
In a study designed to mimic actual user conditions for external insulin pump infusion, the insulin quality after passage through the infusion set was assessed by various analytical methods, including high performance liquid chromatography. The two infusion sets tested consisted of, firstly, a polyvinylchloride/rubber syringe and a polyvinylchloride catheter sterilized by gamma irradiation and, secondly, a polyethylene/polypropylene syringe connected to a polyethylene catheter and sterilized by ethylene oxide. The insulin solution delivered through the PVC infusion set showed a reduction of preservative to less than 30% of the initial content and increased formation of chemical transformation products of insulin varying from twice the reference level during the first day to more than three times on the third day. By contrast, the polyethylene/polypropylene infusion system showed only a minor decrease in preservative content and no increase in chemical transformation. These effects were observed irrespective of the brand of insulin and were not affected by increase of the zinc content of the insulin solution. Investigation of the influence of the sterilization methods performed on polyvinylchloride and polyethylene catheters revealed that gamma irradiated polyvinylchloride catheters were markedly harmful to the insulin solution, whereas ethylene oxide sterilization did not influence the chemical stability of insulin.
在一项旨在模拟外部胰岛素泵输注实际用户条件的研究中，通过包括高效液相色谱在内的各种分析方法评估了胰岛素通过输注装置后的质量。测试的两种输注装置，第一种是经伽马射线辐照灭菌的聚氯乙烯/橡胶注射器和聚氯乙烯导管，第二种是连接到聚乙烯导管并经环氧乙烷灭菌的聚乙烯/聚丙烯注射器。通过PVC输注装置输送的胰岛素溶液中防腐剂减少至初始含量的30%以下，胰岛素化学转化产物的形成增加，从第一天的参考水平的两倍到第三天的三倍以上。相比之下，聚乙烯/聚丙烯输注系统仅显示防腐剂含量略有下降，且化学转化没有增加。无论胰岛素品牌如何，均观察到这些影响，且不受胰岛素溶液锌含量增加的影响。对聚氯乙烯和聚乙烯导管上进行的灭菌方法的影响进行的调查表明，伽马射线辐照的聚氯乙烯导管对胰岛素溶液有明显危害，而环氧乙烷灭菌不影响胰岛素的化学稳定性。
