基于临床用药导向的中药有害成分风险评估方法应用研究

Research on the application of clinical drug-oriented risk assessment method for harmful components of traditional Chinese medicine

目的以临床用药为导向,探索中药有害成分风险评估方法的实用性。方法以款冬花、广藿香、番泻叶、紫草等药材为例,基于微波消解法结合电感耦合等离子体质谱法(ICP-MS)测定药材及饮片中铅(Pb)、镉(Cd)、砷(As)、汞(Hg)、铜(Cu)5种重金属及有害元素的残留水平,综合4种药材用药频率、使用时限、水煎转移率等实际临床用药因素,结合安全因子赋予权重,并依据有害成分的致癌性进行健康风险评估。结果款冬花、广藿香、番泻叶、紫草药材中5种重金属及有害元素均有不同水平的残留,应用涵盖中药临床使用特点的风险评估结果表明,Pb、Cd、As、Hg、Cu整体非致癌性风险较小,危害系数(THQ)均小于1;此外Pb、As、Cd 3种元素致癌风险(CR)均小于1×10^(-6),整体致癌风险较低。结论以临床用药为导向的中药有害成分风险评估方法整体实用性较强,能够贴近临床实际反映中药有害成分的健康风险,为指导临床合理用药奠定基础。

Objective To explore the practicability of risk assessment methods for harmful components of traditional Chinese medicine(TCM)based on clinical medication.Methods The samples were processed by microwave digestion,and lead(Pb),cadmium(Cd),arsenic(As),mercury(Hg),copper(Cu)in Farfarae Flos,Patchouli,Sennae Folium and Arnebiae Radix by inductively coupled plasma mass spectrometry(ICP-MS)were determined.Based on clinical drug use factors such as drug frequency,use time limit,and decoction transfer rate,the health risk assessment of the carcinogenicity of harmful components in TCM was carried out.Furthermore,it also given weight to the security factor.Results The content levels of five heavy metals and harmful elements in Farfarae Flos,Patchouli,Sennae Folium and Arnebiae Radix were different.According to the risk assessment method with the characteristics of clinical use of TCM,the overall non-carcinogenic risk of Pb,Cd,As,Hg,and Cu was low,and the hazard coefficient(THQ)was less than 1.In addition,the carcinogenic risk(CR)of the three elements Pb,As,and Cd were all less than 1×10^(-6),and the overall carcinogenic risk was low.Conclusion The clinical drug-oriented risk assessment method for harmful components of TCM has strong overall practicability.It can reflect the risk of drug use of TCM and guide clinical rational drug use.