Safety Monitoring

Determination and preliminary risk assessment of calcium and five heavy metals in Fufang Zhenzhu Kouchuang granules*

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  • Beihai Institute for Food and Drug Control, Beihai 536000, China

Received date: 2023-02-17

  Online published: 2024-06-24

Abstract

Objective: To establish a method for the simultaneous determination of calcium(Ca) and five heavy metals including arsenic(As), cadmium(Cd), lead(Pb), copper(Cu) and mercury(Hg)in Fufang Zhenzhu Kouchuang granules by inductively coupled plasma mass spectrometry(ICP-MS). And to preliminarily evaluate the risk of As, Cd, Pb, Cu and Hg in the drug. Methods: The samples were determined by ICP-MS, with Sc, Ge, In and Bi as internal standard solutions to eliminate interference after microwave digestion. Based on the basic steps of risk assessment with comparing the determination results, the risk of heavy metal pollution of Fufang Zhenzhu Kouchuang granules was preliminary assessed. Results: Six elements showed good linearity in the range of 0-20 000 ng·mL-1 with the correlation coefficients(r>0.999 1), the relative standard deviation of the precision and repeatability tests were less than 3%, the limits of detection were 0.001-0.9 mg·kg-1, and the average recoveries were in the range of 95.3%-102.8%. Detection results of 10 batches sample were as follows: the content of Ca was 4 073.2-7 144.2 mg·kg-1, the maximum mass of As, Cd, Pb and Cu were 0.184 3, 0.260 4, 0.377 3, 5.977 3 and 0.001 mg·kg-1, respectively.The target hazard quotients(THQs)for five elements obtained from the risk assessment results were in the order of Cd, Pb, As, Cu and Hg. The average THQ of Cd was 0.67, which was obviously higher than those for other four elements.Conclusion: The method is sensitive, accurate, good repeatability, stable, reliable, simple and rapid, which can be used for the determination of Ca and five heavy metals (As, Cd, Pb, Cu and Hg) in Fufang Zhenzhu Kouchuang granules. Based on the preliminary scientific evaluation of the risks arising from the residues of heavy metals, it can provide reference for clinical medication safety and reasonability for Fufang Zhenzhu Kouchuang granules.

Cite this article

LIU Yan-yun, JIANG Ju-qiong, ZHANG Quan, LIANG Shao-dong, WU Guo-yi . Determination and preliminary risk assessment of calcium and five heavy metals in Fufang Zhenzhu Kouchuang granules*[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(9) : 1500 -1506 . DOI: 10.16155/j.0254-1793.2023.09.07

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