氯化钠基础输液中不溶性微粒控制水平的研究

Study on the Control Level of Insoluble Particles in Sodium Chloride Injections

目的:通过对氯化钠基础输液(36批次)的不溶性微粒进行数量和形态分析,研究不同生产工艺对不溶性微粒的影响,探讨提高进口和国产基础输液中不溶性微粒控制水平的方法。方法:采用光阻法和微流成像技术(MFI)分析产品中2~10μm通道处的不溶性微粒数量,对结果进行统计学分析。结果:在2~10μm通道处的不溶性微粒数量百分比均大于90%。注塑拉伸吹塑成型工艺(ISBM)产品的不溶性微粒数量平均值、极差小于吹灌封一体成型工艺(BFS),但是两者无显著性差异。包装对不溶性微粒数量有显著性影响,直立式聚丙烯输液袋(双阀)样品的不溶性微粒平均值最低,与其他三种包装有显著性差异。生产线对不溶性微粒有显著性影响,在相同工艺、包装条件下,生产线不同,结果存在差异。采用MFI技术分析,不溶性微粒的平均值结果与光阻法成线性相关,不溶性微粒的来源可能有胶塞碎屑、塑料颗粒和纤维。结论:不同生产线输液产品不溶性微粒数量在2~10μm通道处具有显著差异,提示应重视对<10μm通道处不溶性微粒的控制,为提升国产和进口基础输液安全性提供策略。

Objective:To investigate the impact of different production processes on insoluble particles and explore methods to improve the control level of insoluble particles in imported and domestic infusion through the analysis of quantity and morphology of insoluble particles in 36 batches of sodium chloride basic infusion.Methods:The number of insoluble particles between 2-10μm was analyzed by light obscuration method and microflow imaging(MFI),and the results were statistically analyzed.Results:The percentage of insoluble particles in 2-10μm channels was greater than 90%.The average and range of insoluble particles in products made by ISBM were smaller than those made by BFS,however,there was no significant difference between them.The packaging had a significant impact on the number of insoluble particles.The average value of insoluble particles in the upright polypropylene infusion bag(double valve)samples was the lowest,which showed a significant difference compared to the other three kinds of packaging.The production line had a significant impact on insoluble particles.Under the same process method and packaging conditions,the results of different production lines were different.The average value of insoluble particles analyzed by MFI was linearly correlated with the light obscuration method.The sources of insoluble particles may include rubber plug debris,plastic particles,and fibers.Conclusion:There is a significant difference in the number of insoluble particles in different products between 2-10μm,indicating that attention should be paid to the control of insoluble particles(<10μm).This study provides strategies to improve the safety of domestic and imported basic infusion.