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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 physical and chemical effects of BFS and traditional infusion packaging on pharmaceuticals. Methods: The test uses bacterial endotoxin, insoluble particles analysis method for comparison. Bacterial endotoxins were assayed for endotoxin content by endpoint chromogenic substrate assay. Insoluble particles were analyzed by whole-sample photoplethysmography for particle size and amount. Results: The results of bacterial endotoxin test showed that there was no significant difference between BFS and traditional packaging materials. The results of insoluble particles showed that the number of insoluble particles ≥5μm and ≥10μm in BFS packaging products was significantly less than those of traditional packaging products, ≥25μm and ≥ The difference of the number of particles with 50μm particle size was not obvious. Conclusion: The intrinsic quality of BFS is superior to other traditional infusion packaging materials.