何首乌中外源性有害残留物的风险评估与其致肝毒相关性初评

目的：了解何首乌饮片（包括生品和制品）中外源性有害物质的残留状况，并对其进行风险评估，以对外源性物质可能引起的何首乌药用安全风险进行初步评价。方法：采用气相色谱-三重四极杆质谱联用仪和液相色谱-三重四极杆质谱联用仪检测何首乌中187种农药的残留量（包括33种禁用农药），采用电感耦合等离子体质谱法测定5种重金属及有害元素，以高效液相色谱-柱后光化学衍生法测定4种黄曲霉毒素；同时采用危害指数法及暴露边界比法对何首乌中检出的有害残留物进行风险评估。结果：53批样品中4种黄曲霉毒素B1、B2、G1、G2和33种禁用农药均未检出，检出的其他农药有多菌灵、啶虫脒及吡唑醚菌酯，检出残留量均低于0.01 mg/kg；重金属检测中均未检出Hg,Pb、Cd、As、Cu的检出值均低于《中华人民共和国药典》2020年版四部通则0923规定限度。通过危害指数法对何首乌中检出的农药和重金属进行风险评估，得到风险商远小于1。结论：何首乌中外源性有害残留所引起的药用风险很低，尤其并未检出可致肝损伤的外源性有害指标，初步表明何首乌肝损伤与外源性污染相关性不大。

Risk Assessment of Exogenous Harmful Residues in Polygonum Multiflorum Thunb and Its Correlation with Liver Injury

Objective: To study the exogenous harmful residues and carry out risk assessment in the decoction pieces of Polygonum multifl orum Thunb (P. multiflorum) in order to preliminarily evaluate the medicinal safety risk of P. multiflorum caused by exogenous substances. Methods: The residues of 187 pesticides (including 33 banned pesticides) in P. multiflorum were determined by gas chromatography-tandem mass spectrometry (GC-MS-MS) and liquid chromatography-tandem mass spectrometry (LC-MS-MS). Five heavy metals and harmful elements were determined by inductively coupled plasma mass spectrometry (ICP-MS) method, and four aflatoxins were determined by high performance liquid chromatography with column photochemical derivatization. Meanwhile, the hazard index method and exposure boundary ratio method were used to evaluate the risk of harmful residues detected in P. multiflorum. Results: Aflatoxin B1, B2, G1, G2 and 33 banned pesticides were not detected in 53 batches of samples. The other detected pesticide indexes included carbendazim, acetamiprid and pyraclostrobine, and the detected residues were less than 0.01 mg/kg. Hg was not found in the heavy metal detection, and the detection values of Pb, Cd, As and Cu were lower than the limit specifi ed in the general rules 0923 of Part IV of Chinese Pharmacopoeia 2020. The risk quotient of pesticides and heavy metals detected in P. multiflorum was far less than 1 by the hazard index method. Conclusion: The risk caused by exogenous harmful residues in P. multiflorum is low, especially the exogenous harmful indexes that can cause liver injury are not detected, indicating that there is little correlation between liver injury and exogenous pollution.