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ICP-OES法测定新型冠状病毒疫苗中32种元素杂质的含量

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目的 建立检测新型冠状病毒疫苗中32种元素杂质含量的方法。方法 采用电感耦合等离子体发射光谱法(ICP-OES),通过半定量筛查和定量检测的方式,测定疫苗中的元素杂质含量,并考察该方法的专属性、线性、定量限、检测限、加标回收率等情况,评估该方法用于疫苗中微量元素含量检测的可行性。结果 各元素在各自的检测质量浓度范围内线性关系良好,元素加标回收率在94。06%~115。50%,应用于各加速放置点样品的检测时,除硼(B)、硅(Si)元素测得微量含量,且长期放置后含量增长不明显,其余元素含量均远小于规定限度。结论 建立ICP-OES法,该方法专属性好,结果可靠,简便快捷,适用于新型冠状病毒疫苗中32种元素杂质的检测。
Determination of 32 Elemental Impurities in COVID-19 Vaccine by ICP-OES
OBJECTIVE To establish a method for the determination of 32 elements in COVID-19 vaccine.METHODS The 32 elements were determined by inductively coupled plasma optical emission spectrometer(ICP-OES)through semi-quantitative screen-ing and quantitative detection,and the specificity,linearity,limit of quantification,detection limit and recovery rate of the ICP-OES method were investigated to evaluate the feasibility of the method for the detection of trace elements in vaccines.RESULTS The line-ar relationship of each element was good within the detection mass concentration range,and the recoveries of element added were 94.06%-115.50%.When applied to the detection of the samples at each accelerated placement point,except for the trace contents of B and Si elements,which did not increase significantly after long-term placement,the contents of other elements were far less than the prescribed limits.CONCLUSION The ICP-OES method is established And the method has good specificity,reliable results,simple and rapid,and is suitable for the determination of 32 elements in COVID-19 vaccine.

ICP-OESCOVID-19 vaccine32 element

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上海市食品药品包装材料测试所,上海 201203

电感耦合等离子体发射光谱法 新型冠状病毒疫苗 32种元素

2024

中国药学杂志
中国药学会

中国药学杂志

CSTPCD北大核心
影响因子:0.957
ISSN:1001-2494
年,卷(期):2024.59(3)
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