不同厂家牛黄解毒片中24种无机元素ICP-MS检测与质量评价

Study on 24 Inorganic Elements in Niuhuang Jiedu Tablets from Different Manufacturers Based on ICP-MS and Statistical Analysis Differences for Quality Evaluation

目的:建立牛黄解毒片中无机元素指纹图谱,结合化学计量学探究不同厂家产品中无机元素差异,评价他们质量的均一性。方法:对全国21个生产企业的牛黄解毒片,采用微波消解后-ICP-MS法测定样品中K、Mn、Zn等24种无机元素的含量,绘制无机元素质量分数分布图,通过主成分分析法对质量均一性进行评价。结果:24种元素ICP-MS测定在各自范围内线性关系均良好(r≥0.9996),回收率在86.9%~112.2%之间(RSD≤1.6%)。建立了牛黄解毒片无机元素指纹图谱,从指纹图谱相似度及PCA结果看,牛黄解毒片中无机元素的质量均一性较好,主要特征元素为K、Mn、Zn、B、Ni、Al、V、Cr、Ba、Sn。结论:本研究建立的无机元素指纹图谱可为牛黄解毒片质量评价提供研究基础。

Objective:To establish fingerprints of inorganic elements in Niuhuang Jiedu Tabletss,explore their differences from different manufacturers with chemometrics,and evaluate their quality uniformity.Methods:An ICP-MS method after microwave digestion was employed for the determination of the contents of 24 inorganic elements including K,Mn and Zn in Niuhuang Jiedu tablets from 21 production enterprises nationwide.A distribution map of inorganic element mass fraction was drawn and the quality uniformity was evaluated through principal component analysis.Results:The linear calibrations were established for the ICP-MS determination of the 24 elements(with r≥0.999),and the recoveries were 86.9%-112.2%(RSD≤1.6%).The fingerprints of inorganic elements in Niuhuang Jiedu tablets were established.From the similarity of the fingerprints and PCA results,the quality uniformity of inorganic elements in Niuhuang Jiedu tablets was confirmed,with the main characteristic elements being K,Mn,Zn,B,Ni,Al,V,Cr,Ba and Sn.Conclusion:The inorganic element fingerprints established at the same time can provide a research basis for the quality evaluation of Niuhuang Jiedu tablets.