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| 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 of insoluble particles in sodium chloride injections |
| 投稿时间：2024-04-23 修订日期：2024-08-16 |
| DOI： |
| 中文关键词: 不溶性微粒 基础输液 MFI 光阻法 |
| 英文关键词: insoluble particles basic intravenous infusion MFI light obstruction method |
| 基金项目: |
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| 中文摘要: |
| 目的：通过对氯化钠基础输液(36批次)的不溶性微粒检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。本研究以氯化钠基础输液(36批次)为研究对象,旨在了解当前产品中不溶性微粒控制水平,探讨包装形式、工艺和生产线对不溶性微粒的影响。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,对实验结果进行统计学分析。结果：实验结果表明,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化工艺(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,本研究为提升国产和进口基础输液安全性提供策略。 |
| 英文摘要: |
| Objective: With the analysis of quantity and morphology of insoluble particles in 36 batches of sodium chloride basic infusion, this study investigates the impact of different production processes on insoluble particles and explores methods to improve the control level of insoluble particles in imported and domestic infusion.This study focused on 36 lots of sodium chloride injections, which is aimed to understand the current level of insoluble particle control in products, and to explore the impact of packaging form, process, and production line on insoluble particles. Methods: The number of insoluble particles between 2~10 μm was analyzed using light obscuration method and MFI, and the data were statistically analyzed. Results: The percentage of insoluble particles is greater than 90%. The average and range of insoluble particles in products made by ISBM are smaller than those made by BFS, however, there is no significant difference between the two process methods. The packaging has a significant impact on the number of insoluble particles. The average value of insoluble particles in the upright polypropylene infusion bag (double valve) samples is the lowest, which shows a significant difference compared to the other three types of packaging. The production line has a significant impact on insoluble particles. With the same process method and packaging conditions, the results may vary depending on the production lines. The average value of insoluble particles analyzed by MFI is 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 (＜10μm) . This study provides strategies to improve the safety of domestic and imported basic infusion.The study provides strategies to improve the safety of basic intravenous infusion. |
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