Analysis of inorganic elements compositions of Naozhenning Granules by ICP-MS / 中草药

ABSTRACT

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.