目的 采用层次分析（analytic hierarchy process，AHP）-基于指标相关性的权重确定方法（criteria importance though intercrieria correlation，CRITIC）复合加权法优选牡蛎的炮制工艺，并对牡蛎药材和煅牡蛎饮片的重金属及有害元素进行健康风险评估。方法 采用单因素试验，结合热重-差热分析（thermogravimetric-differential thermal analysis，TG-DTA）、傅里叶变换红外光谱（Fourier transform infrared spectroscopy，FTIR）和X射线衍射光谱（X-ray diffraction spectroscopy，XRD）技术，对不同温度所得牡蛎煅制品进行表征与分析，初步确定煅制温度。采用正交试验，以CaCO₃、5种重金属及有害元素含量、饮片得率和酥脆程度为指标，基于AHP-CRITIC复合加权法优选最佳炮制工艺。采用电感耦合等离子体质谱（inductively coupled plasma mass spectrometry，ICP-MS）法检测牡蛎药材和煅牡蛎饮片中Pb、Cd、As、Hg、Cu 5种重金属及有害元素含量。以原粉入药为例，计算靶标危害系数（target hazard quotients，THQ）和致癌风险（carcinogenic risk，CR），对牡蛎药材和煅牡蛎饮片的重金属及有害元素进行健康风险评估。结果 优化后的牡蛎炮制工艺为煅制温度650 ℃，煅制时间90 min，药材直径2～3 cm。炮制后的煅牡蛎饮片中CaCO₃含量变化不大，重金属及有害元素含量降低。健康风险评估模型THQ和CR结果显示，22批牡蛎药材和煅牡蛎饮片均不会对暴露人群产生明显健康危害，无潜在致癌风险，且煅牡蛎饮片较牡蛎药材的健康风险显著降低（P＜0.05）。结论 将重金属及有害元素含量纳入评价指标，使结果更具全面性，采用AHP-CRITIC复合加权法将主、客观相结合以优选牡蛎的煅制工艺，所得工艺科学可靠，稳定可行，为牡蛎等贝壳类中药的炮制工艺研究提供了实验思路与方法。对牡蛎药材和煅牡蛎饮片的重金属及有害元素进行健康风险评估，为中医临床用药安全和含牡蛎保健食品的长期安全服用提供了科学依据。

Objective To optimize the calcination process of Muli (Ostreae Concha) by AHP-CRITIC mixed entropy method, and health risk of heavy metals and harmful elements were evaluated in Ostreae Concha medicinal materials and calcined Ostreae Concha decoction pieces. Methods A one-way test, combined with thermogravimetric-differential thermal analysis (TG-DTA), Fourier transform infrared spectroscopy (FTIR) and X-ray diffraction spectroscopy (XRD), was used to characterize and analyze the calcined Ostreae Concha decoction pieces obtained at different temperatures, and to preliminarily determine the calcination temperature. The optimal processing parameters were optimized based on the AHP-CRITIC method through orthogonal tests with calcium carbonate (CaCO₃) content, heavy metals elements content, yield and crispiness as indicators. Inductively coupled plasma mass spectrometry (ICP-MS) was employed to detect the contents of five heavy metals elements, namely, Pb, Cd, As, Hg and Cu, in Ostreae Concha medicinal materials and calcined Ostreae ConchaOstreae Concha medicinal materials and calcined Ostreae Concha decoction pieces. Results The optimized calcination process is 2—3 cm in diameter of Ostreae Concha, and calcining for 90 minutes at 650 ℃. After processing, the CaCO₃ content of calcined Ostreae Concha decoction pieces did not change much, the heavy metal and harmful elements contents were reduced. As demonstrated by health risk assessment based on the THQ and CR models, these 22 bathes of Ostreae Concha medicinal materials and calcined Ostreae Concha decoction pieces did not cause significant health hazards for the exposed populations, and there was no potential carcinogenic risk. And the health risk of 22 bathes of calcined Ostreae Concha decoction pieces was significantly reduced compared with the original medicinal materials (P < 0.05). Conclusion In this study, heavy metals and harmful elements were included in the evaluation indexes to make the results more comprehensive. The AHP-CRITIC mixed entropy method combines subjective and objective factors to optimize the calcination process of Ostreae Concha, and the scoring results are scientific and reliable, and the process was stable and feasible, which provided experimental ideas and methods for the study of the concoction process of Ostreae Concha and other testacean traditional Chinese medicine. The health risk assessment of heavy metal elements in Ostreae Concha medicinal materials and calcined Ostreae Concha decoction pieces provides a scientific basis for the safety in clinic and the long-term safety of Ostreae Concha-containing in health food.

R283.6

国家重点研发计划—中医药现代化专项（2023YFC3504101）;国家中医药管理局应用基础研究课题（gzyjc20210901）