黄柏胶囊中7种重金属含量分析及风险评估  

Contents of 7 types of heavy metals in Huangbai capsules and risk assessment

作　　者：徐夏 卢姗姗 谭林燕 符秀娟[3] Xu Xia;Lu Shan-shan;Tan Lin-yan;Fu Xiu-juan(The First People’s Hospital of Chunan,Hangzhou 311700,China;Hangzhou Hospital of Traditional Chinese Medicine,Hangzhou 310007,China;Hainan College of Vocation and Technique,Haikou 570216,China)

机构地区：[1]浙江省淳安县第一人民医院,杭州311700 [2]杭州市中医院,杭州311700 [3]海南职业技术学院,海口570216

出　　处：《中国药物应用与监测》2024年第1期38-41,共4页Chinese Journal of Drug Application and Monitoring

基　　金：海南省自然科学基金项目(822MS087)。

摘　　要：目的建立黄柏胶囊中铬、铅、汞、镉、砷、铜、锑7种重金属元素的含量检测方法,并对其进行安全风险评估。方法样品经消解成溶液后,以钇、铟、铋、铽为内标,使用电感耦合等离子体质谱仪(ICP-MS)测定7种元素含量,运用危害指数法(HI)对各元素安全风险进行评估。结果7种元素线性关系良好(r≥0.9980),平均回收率为88.4%~102.0%。含量结果表明30批样品有1批铬超标,6批铅超标,1批汞超标,而安全风险评估结果显示各元素HI叠加值<1。结论该制剂中7种重金属元素残留量整体上所致的安全风险较低,但需注意个别企业多批次样品中铅等超标问题,可考虑在现行质量标准中增加铅、汞和铬的检查项。Objective To establish a method for detection of 7 types of heavy metal elements chromium,lead,mercury,cadmi-um,arsenic,copper and antimony in Huangbai capsules and evaluate the safety.Methods After the samples were dissolved into solution,the contents of the 7 elements were determined by inductively coupled plasma mass spectrometer(ICP-MS)with yttrium,indium,bismuth and terbium served as internal standards,and the safety risk of each element was assessed by hazard index(HI)method.Results There was favorablelinear relationship among the 7 elements(r≥0.9980),and the average recovery rate ranged between 88.4%and 102.0%.The result of content test showed that among 30 batches of samples,there was 1 batch with chromium exceeded the standard,6 batches with lead exceeded the standard and 1 batch with mercury exceeded the standard.While the result of safety risk assessment showed that the HI superposition value of each element was less than 1.Conclusion The residual quantity of the 7 types of heavy metal elements in the preparation may induce a low risk of safety.However,it is necessary to pay attention to the exceeding standard problems of some batches of samples from several enterprises and take adding the test items of lead,mercury and chromium to the current quality standards into account.

关 键 词：黄柏胶囊 重金属 电感耦合等离子体质谱仪 风险评估 

分 类 号：R286.0[医药卫生—中药学]