补益类中成药中重金属及有害元素的风险评估  

The Risk Assessment of Heavy Metals and Harmful Elements in Tonic Chinese Medicines

作　　者：熊江云 周峰旭 何恩彦 吕冠欣 何积芬 XIONG Jiangyun;ZHOU Fengxu;HE Enyan;LV Guanxin;HE Jifen(Institute for Drug Control of Shunde District of Foshan,Foshan,Guangdong 528300,China;Key Laboratory of Drug Metabolism Research and Evaluation of National Medical Products Administration,Guangzhou,Guangdong 510515,China)

机构地区：[1]佛山市顺德区药品检验所,广东佛山528300 [2]国家药品监督管理局药物代谢研究与评价重点实验室,广东广州510515

出　　处：《今日药学》2023年第4期278-283,共6页Pharmacy Today

基　　金：广东省药品监督管理局科技创新立项项目(2021TDB05)。

摘　　要：目的对3种含朱砂原粉的补益类中成药(天王补心丸、朱砂安神丸、补肾益脑胶囊)中5种可溶性重金属及有害元素进行含量测定及风险评估。方法采用仿生提取-ICP-MS法测定3种补益类中成药中铅(Pb)、砷(As)、汞(Hg)、镉(Cd)和铜(Cu)的含量,并结合《中药中外源性有害残留物安全风险评估技术指导原则》,分别采用危害指数法(HI)和暴露限值法(MOE)对其进行风险评估。结果天王补心丸和补肾益脑胶囊中各重金属及有害元素的HI值均小于1,MOE值均大于1,说明两种中成药的健康风险较低,但10批朱砂安神丸中,有7批样品汞的HI值大于1,有1批样品Pb元素的MOE值小于1,提示存在健康风险。结论补益类中成药中由朱砂原粉引入的安全风险需要进行长期科学评估,对含朱砂药品的说明书须进行规范化要求。OBJECTIVE To determine and assess the risk of 5 soluble heavy metals and harmful elements in three tonic Chinese medicines containing raw powder of Zhusha(Tianwang Buxin pills,Zhusha Anshen pills and Bushen Yinao capsules).METHODS The contents of Pb,As,Hg,Cd and Cu in three kinds of tonic Chinese medicines were processed by bionic extraction method and determined by ICP⁃MS,and the risk assessment was performed by hazard index(HI)and exposure limitation method(MOE)respectively in accordance with the Guideline of Risk Assessment of Exogenous Harmful Residues in Traditional Chinese Medicines.RESULTS The HI values of Tianwang Buxin pills and Bushen Yinao capsules were both less than 1,and the MOE values were both more than 1,indicating that the health risks of the two Chinese medicines were low.However,among the 10 batches of Zhusha Anshen pills,there were 7 batches of samples with the HI value of Hg greater than 1,and 1 batch of sample with the MOE value of Pb was less than 1,suggesting the existence of hidden health risks.CONCLUSION The potential safety risks introduced by the original powder of Zhusha in tonic Chinese medicines need long⁃term scientific assessment,and the instructions for medicines containing raw powder of Zhusha need to be standardized.

关 键 词：天王补心丸 朱砂安神丸 补肾益脑胶囊 仿生提取-ICP-MS法 重金属及有害元素 

分 类 号：R927.2[医药卫生—药学]