摘要
目的:比较内封式聚丙烯输液袋(BFS)与传统输液包装材料在物理方面和化学方面对药品的影响。方法:试验采用细菌内毒素、不溶性微粒的分析方法进行比较。细菌内毒素采用终点显色基质法分析样品中内毒素的含量;不溶性微粒采用全取样光阻法分析样品中的微粒大小及数量。结果:细菌内毒素测定结果显示BFS与传统包装材料无明显差异;不溶性微粒测定结果显示,BFS包装的产品≥5μm和≥10μm粒径的不溶性微粒数量明显少于传统包装的产品,≥25μm和≥50μm粒径的微粒数量则差异不明显。结论:BFS内在质量优于其他传统输液包装材料。
Objective： To compare the differences in the physical and chemistry influences on drugs between blow-fill-seal （BFS） infusion bags and traditional infusion bags. Methods： The bacterial endotoxin and insoluble particles were analyzed. End-point chro- momeric assay arid light blockage method were used to detect the bacterial endotoxin and insoluble particles, respectively. Results： No significant differences in the bacterial endotoxin were found. The results of insoluble particles showed there was significant difference between BFS infusion bags and traditional infusion bags. The insoluble particles of ≥5μm or ≥10 μm in the products packed by BFS infusion bags were less than those packed by traditional infusion bags. The number of insoluble particles of ≥25μm or ≥50 μm was no significant difference between them. Conclusion： The quality of BFS infusion bags is better than that of traditional infusion bags.
出处
《中国药师》
CAS
2016年第11期2147-2150,共4页
China Pharmacist
基金
国家药典委员会课题"内封式聚丙烯输液袋质量标准提高"
关键词
内封式聚丙烯输液袋
细菌内毒素
不溶性微粒
Blow-fill-seal polyprepylene infusion bags
Bacterial endotoxin
Insoluble particles
