Study on the Control Level of Insoluble Particles in Sodium Chloride Injections
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 2-10 μm was analyzed by light obscuration method and microflow imaging(MFI),and the results were statistically analyzed.Results:The percentage of insoluble particles in 2-10 μm 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 2-10 μm,indicating that attention should be paid to the control of insoluble particles(＜10 μm).This study provides strategies to improve the safety of domestic and imported basic infusion.
万方数据
维普
