采用不同时间/温度组合优化林格斯/葡萄糖输注液灭菌。

J P Mannermaa, E Muttonen, J Yliruusi, L Määttänen
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摘要

描述了灭菌温度和灭菌效果(F0)对5-羟甲基-2-呋喃醛(5-HMF)和葡萄糖的量、生成的颗粒数和林格/葡萄糖输注液颜色的影响。输注液为含有林格型电解质的5%葡萄糖溶液。溶液在中试规模的高压灭菌器中使用不同的温度/时间组合进行高压灭菌,以产生10、15、20和25分钟的目标F0值。用高效液相色谱法测定5-羟甲基糠醛和葡萄糖的含量。使用尽可能短的灭菌周期产生目标F0导致所研究的林格/葡萄糖输注溶液中5-HMF浓度最低。无菌溶液的光谱图谱表明,葡萄糖在林格型电解质的存在下被降解为各种降解产物。SEM/EDX还表明,很大一部分颗粒是由用于制造LVP溶液的橡胶塞的硅油的浸出造成的。用Coulter-Counter测定了不同溶液中产生的颗粒数和粒径分布。灭菌工艺条件与颗粒数之间的粒度分布无明显的相关性。结果表明,即使使用相同的F0,也可以通过选择尽可能高的灭菌温度来最小化5-HMF的生成量。这也导致在实践中更短的灭菌过程,节省处理时间和能源。
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The use of different time/temperature combinations in the optimization of sterilization of Ringers/glucose infusion solution.

The effect of sterilization temperature and sterilization efficacy (F0) on the amount of 5-hydroxymethyl-2-furaldehyde (5-HMF) and glucose, number of particles generated and color of Ringers/glucose infusion solution is described. The infusion solution was a 5% glucose solution containing Ringer-type electrolytes. The solutions were autoclaved in a pilot scale autoclave using different temperature/time combinations to produce the target F0 values of 10, 15, 20 and 25 minutes. The amounts of 5-HMF and glucose were determined by HPLC. The use of the shortest possible sterilization cycle to yield the target F0 resulted in the lowest 5-HMF concentrations in the Ringers/glucose infusion solutions studied. The spectrochromatograms of the sterilized solutions showed that glucose is degraded into various degradation products in the presence of Ringer-type electrolytes. It was also demonstrated by SEM/EDX that a significant part of the particles result from the leaching of the silicon oil used in the manufacture of rubber stoppers for LVP solutions. The number of particles generated in different solutions and the particle size distributions were determined with a Coulter-Counter. The particle size distributions show no clear correlation between sterilization process conditions and the number of particles. The results show that it is possible to minimize the amount of 5-HMF generated even when the same F0 is used, by choosing the highest sterilization temperature possible. This also leads in practice to the shorter sterilization processes, saving both process time and energy.

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