目的 研究全国4个不同生产企业的52批山楂丸样品中Cu、As、Cd、Hg、Pb 5种有害元素。方法 采用微波消解-电感耦合等离子体质谱技术（ICP-MS）进行残留量测定，采用高效液相色谱联合电感耦合等离子体质谱技术（HPLC-ICP-MS）分析受污染样品中As、Hg的价态形态，应用单项污染指数（P_i）和综合污染指数（P）法对样品污染程度进行评价。结果 5种有害元素的线性关系良好（r≥0.999 4），检出限为0.4～5.6 μg/kg，加样回收率为92.54%～102.79%，RSD值< 3.5%；所测样品中Cu、Cd、Pb均符合《药用植物及制剂进出口绿色行业标准》限量规定，但来自吉林的1个生产企业的部分样品（S30、S37）中As超出限量、全部样品中Hg超出限量。样品中的As、Hg主要以亚砷酸（三价As）、砷酸（五价As）和二价Hg的形态存在。经污染指数评价，52批样品中污染程度达安全级有32批；警戒级有2批（S17、S25），均来自天津的生产企业，占该企业样品的7.41%；轻度污染有1批（S38），中度污染有1批（S40），重度污染有16批（S28～S37、S39、S41～S45），污染样品均来自吉林的生产企业，该企业样品全部存在污染。结论 我国市售的山楂丸的重金属污染情况因生产企业不同而差异极大，应引起高度重视；以上研究为进一步开展中药制剂安全性研究提供参考。

Objective To study Cu, As, Cd, Hg, and Pb in 52 batches of of hawthorn pill samples from four different production enterprises in China. Methods The residues of five heavy metal elements were determined with microwave digestion-inductively coupled plasma mass spectrometry (ICP-MS). The valence of As and Hg in the contaminated samples was analyzed with HPLC-ICP-MS. The heavy metal pollution in hawthorn pill was evaluated with the single and comprehensive pollution index method. Results The method had good linear correlation (r ≥ 0.999 4) .The detection limit ranges of five heavy metal elements were from 0.4 to 5.6 μg/kg. The recovery values ranged from 92.54% to 102.79%. The relative standard deviations for all elements were less than 3.5%. Green Standards of Foreign Trading Medicinal Plants & Preparations was used as the standard to evaluate the pollution status of Cu, As, Cd, Hg, and Pb in hawthorn pill. The results showed that the residues of Cu, Cd, and Pb were all bellow the limit of the standard, however, the As of some samples (S30, S37) from the production enterprise in Jilin exceeded the limit, Hg in all samples exceeded the limit. The As and Hg mainly existed in the form of arsenous acid (3), arsenic acid (5) and bivalent mercury. After the evaluation, there were 32 batches of safety level samples, two batches of warning level samples (S17, S25) from the production enterprise in Tianjin, which was occupied 7.41% of their samples, one batch of mild level polluted sample (S38), one batch of moderate level polluted sample (S40), and 16 batches of high level polluted samples (S28—S37, S39, S41—S45) from the production enterprise in Jilin, all samples from that enterprise were contaminated. Conclusion The heavy metal pollution levels of hawthorn pill sold in china shows distinct difference since the different production enterprises, which should attach great importance to it. The study provides a reference for further research on safety of Chinese medicine.

国家科技重大专项课题“重大新药创制”项目：中药质量安全检测和风险控制技术平台（2014ZX09304307-002）；广西重大专项计划项目：壮药质量标准及质量控制技术规范化研究（桂科重1598005-10）