目的：采用5种不同粒径的聚苯乙烯微粒标准品以及6种单克隆抗体（单抗）样品作为模型体系,对比2种微流成像仪（MFI 5100 仪和MFI 5200 仪）在粒径测量、计数结果和图像质量上的差异。方法：采用配备自动进样器的MFI 5100 仪和MFI 5200 仪对5、10、15、25 和50 μm 5种聚苯乙烯微粒标准品进行分析,将所得数据与光阻法分析结果以及标示值进行比较;采用配备自动进样器的MFI 5100 仪和MFI 5200 仪对6种单抗样品进行分析,将所得数据与光阻法分析结果进行比较。结果：对于聚苯乙烯微粒标准品,MFI 5100 仪和MFI 5200 仪均具有较好的粒径测量和计数分析精密度,其粒径分析结果与标示值吻合,而计数分析结果则较标示值及光阻法测定值偏低。MFI 5200 仪的图像更为清晰,但MFI 5200 仪对微粒标准品的计数值略低于MFI 5100 仪,这可能是2种仪器的结构参数或软件参数差异导致的。单抗样品的计数结果更为复杂,MFI 5100 仪和MFI 5200 仪2种仪器在不同粒径区间检测不同产品的计数结果不尽相同。光阻法对单抗的计数结果较微流成像法偏低。结论：MFI 系列微流成像仪对特定粒子具有较好的测量重复性和粒径测定精度,但仪器之间存在计数差异,实际应用时如作为《中华人民共和国药典》不溶性微粒检查法的补充,应考虑仪器之间的差异并基于样品特性及测试目的对仪器方法设定合理的标准并对数据进行恰当解读。
Objective: To compare the results of two MFI instruments（MFI 5100 and MFI 5200） and demonstrate possible difference after analyzing five polystyrene particle standards and six monoclonal antibodies（mAbs） for sizing,counting and imaging quality. Methods: 5 μm,10 μm,15 μm,25 μm and 50 μm polystyrene particle standards were analyzed by MFI 5100 and MFI 5200 equipped with automated sample injector. Resultswere compared with the data measured by light obscuration as well as certified values. Six different mAbs were also analyzed by MFI 5100,MFI 5200 and HIAC,and the results were also compared. Results: Both MFI instruments have good sizing and counting precision for polystyrene particle standards. The measured particle sizes are comparable with certified values while the counting results are lower than the certified or light obscuration data. MFI 5200 has better image quality,however,MFI 5200 counting results are lower than those of MFI 5100. These differences may due to the differences in instrument design,data process and analysis algorithms. For mAbs, the counting results showed more variation. The two instruments may read higher or lower counts than each other depending on the sample and the sizing range. The counting results by light obscuration were lower than those by micro-flow digital imaging. Conclusion: MFI instruments have good precision and sizing accuracy for polystyrene standard particles. However,instrument differences exist. When used in quality control beyond Chinese Pharmacopeia methods of test for particulate matter in injection for particulate control,instrument variation should be considered and appropriate system suitability standard and data interpretation should be set up based on sample characteristics and the purpose of the method.
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