目的 采用电感耦合等离子体质谱（ICP-MS）法对脑震宁颗粒无机元素组成进行分析，为其产品质量均一性和安全性评价奠定基础。方法 脑震宁颗粒样品进行微波消解处理，采用ICP-MS法定量测定10批样本中18种无机元素的含量，通过Heatmaps图谱、Pearson相关系数图对结果进行分析；通过无机元素指纹图谱、主成分分析（PCA）结合聚类分析对质量均一性进行评价。结果 脑震宁颗粒中无机元素以K、Ca、P、Na、Mg、Fe为主，且不同元素含量之间存在着一定正相关性。As、Hg、Cd、Pb、Cu这5种重金属元素的限量符合《中国药典》2015年版限度规定。采用平均数和中位数法分别建立无机元素对照指纹图谱，从指纹图谱相似度、聚类分析、PCA结果来看，脑震宁颗粒无机元素的质量均一性较好。PCA结果显示，K、Mg、Sr、Mn、P、Pb等元素可能是影响脑震宁颗粒无机元素质量波动的特征元素。结论 本研究初步明确了脑震宁颗粒的无机元素组成，为其质量均一性和安全性评价奠定了基础。

Objective To analyze the inorganic elements composition of Naozhenning Granules (NG) by inductively coupled plasma spectrometer (ICP-MS), in order to evaluate the uniformity and safety of NG. Methods The sample of NG was prepared using the microwave digestion method, and the levels of 18 inorganic elements in 10 batches of NG were determined by ICP-MS. Then the results were analyzed by Heatmaps and Pearson Correlations. The uniformity of the products was evaluated by Inorganic elemental fingerprint, principal components analysis, and Cluster analysis. Results The main inorganic elements in NG were K, Ca, P, Na, Mg, Fe, and there was positive correlations among the different elements. The contents of five heavy metal elements, including As, Hg, Cd, Pb, and Cu, were below the limit of Chinese Pharmacopoeia 2015. The inorganic elements reference fingerprint of NG was generated using the average and median methods. The results of fingerprint similarity, cluster analysis, and principal component analysis showed that the inorganic elements of NG showed good uniformity. The results of principal component analysis showed that K, Mg, Sr, Mn, P, and Pb may be the characteristic elements influencing the quality fluctuation of inorganic elements of NG. Conclusion This study determined the inorganic element composition of NG, which laid a foundation for its uniformity and safety evaluation of NG.

R286.02

山西省重点研发计划（201603D3113003）；山西省中药现代化振东专项基金（2106ZD0404）；山西省研究生联合培养基地人才培养项目（2018JD05）