目的 通过AHP优化的熵权TOPSIS模型对磁石的煅淬工艺进行优选，并对煅磁石饮片的重金属元素残留量进行健康风险评估。方法 通过正交试验，分别以Fe和Pb、As、Cd、Hg、Cu元素的含量为综合评价指标，采用《中国药典》2020年版规定的Fe含量测定法（重铬酸钾滴定法）和电感耦合等离子体质谱法（inductively coupled plasma-mass spectrometry，ICP-MS）进行含量测定，基于AHP-熵权TOPSIS法优选最佳炮制工艺参数。采用风险评估方法对煅磁石的重金属元素安全性进行评估，以磁石原粉入药为例，计算靶标危害系数（target hazard quotients，THQ），并推算煅磁石中各重金属的最大残留限量理论值。结果 优化后的磁石煅淬工艺为煅烧时间90 min，煅烧温度650 ℃，煅淬2次。炮制后的煅磁石Fe含量变化不大，重金属元素含量降低，13批煅磁石饮片较原药材的健康风险显著降低（P＜0.05）。结论 初步制定煅磁石饮片中Pb、As、Cd、Hg、Cu的残留限量理论值依次为40、90、25、17、1 500 mg/kg；为磁石及同类矿物药的临床安全用药提供参考。

Objective To optimize the hardening process of magnetite by the AHP-entropy weight TOPSIS model, and evaluate the health risk of the residual heavy metals elements in the calcined magnetite. Methods Through orthogonal test, the contents of Fe, Pb, As, Cd, Hg and Cu were taken as the comprehensive evaluation index, and the iron content determination method (potassium dichromate titration method) and inductively coupled plasma-mass spectrometry (ICP-MS) were used to determine the content, and the optimal processing parameters were selected based on AHP-entropy weight TOPSIS algorithm. The risk assessment method was used to evaluate the safety of heavy metals elements in calcined magnetite. Taking the application of raw magnetite into medicine as an example, the target hazard quotients (THQ) was calculated, and the theoretical maximum residual limits of heavy metals in calcined magnetite were calculated. Results The optimized calcining and quenching process of magnetite is 90 min at 650 ℃, calcining and quenching for twice. After processing, the iron content of calcined magnetite did not change much, the heavy metal elements contents were reduced, and the health risk of 13 batches of calcined magnetite decoction pieces was significantly reduced compared with the original medicinal materials (P < 0.05). Conclusion The theoretical residual limits of Pb, As, Cd, Hg and Cu in decoction pieces of calcined magnetite were preliminarily established as 40, 90, 25, 17 and 1 500 mg/kg, respectively. This study provides reference for safe clinical use of magnetite and similar mineral medicine.

R286.6

国家重点研发专项——中药饮片质量识别关键技术研究（2018YFC1707000）