目的 采用層次分析（analytic hierarchy process，AHP）-基于指標(biāo)相關(guān)性的權(quán)重確定方法（criteria importance though intercrieria correlation，CRITIC）復(fù)合加權(quán)法優(yōu)選牡蠣的炮制工藝，并對牡蠣藥材和煅牡蠣飲片的重金屬及有害元素進(jìn)行健康風(fēng)險評估。方法 采用單因素試驗，結(jié)合熱重-差熱分析（thermogravimetric-differential thermal analysis，TG-DTA）、傅里葉變換紅外光譜（Fourier transform infrared spectroscopy，F(xiàn)TIR）和X射線衍射光譜（X-ray diffraction spectroscopy，XRD）技術(shù)，對不同溫度所得牡蠣煅制品進(jìn)行表征與分析，初步確定煅制溫度。采用正交試驗，以CaCO₃、5種重金屬及有害元素含量、飲片得率和酥脆程度為指標(biāo)，基于AHP-CRITIC復(fù)合加權(quán)法優(yōu)選最佳炮制工藝。采用電感耦合等離子體質(zhì)譜（inductively coupled plasma mass spectrometry，ICP-MS）法檢測牡蠣藥材和煅牡蠣飲片中Pb、Cd、As、Hg、Cu 5種重金屬及有害元素含量。以原粉入藥為例，計算靶標(biāo)危害系數(shù)（target hazard quotients，THQ）和致癌風(fēng)險（carcinogenic risk，CR），對牡蠣藥材和煅牡蠣飲片的重金屬及有害元素進(jìn)行健康風(fēng)險評估。結(jié)果 優(yōu)化后的牡蠣炮制工藝為煅制溫度650 ℃，煅制時間90 min，藥材直徑2～3 cm。炮制后的煅牡蠣飲片中CaCO₃含量變化不大，重金屬及有害元素含量降低。健康風(fēng)險評估模型THQ和CR結(jié)果顯示，22批牡蠣藥材和煅牡蠣飲片均不會對暴露人群產(chǎn)生明顯健康危害，無潛在致癌風(fēng)險，且煅牡蠣飲片較牡蠣藥材的健康風(fēng)險顯著降低（P＜0.05）。結(jié)論 將重金屬及有害元素含量納入評價指標(biāo)，使結(jié)果更具全面性，采用AHP-CRITIC復(fù)合加權(quán)法將主、客觀相結(jié)合以優(yōu)選牡蠣的煅制工藝，所得工藝科學(xué)可靠，穩(wěn)定可行，為牡蠣等貝殼類中藥的炮制工藝研究提供了實驗思路與方法。對牡蠣藥材和煅牡蠣飲片的重金屬及有害元素進(jìn)行健康風(fēng)險評估，為中醫(yī)臨床用藥安全和含牡蠣保健食品的長期安全服用提供了科學(xué)依據(jù)。

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

國家重點研發(fā)計劃—中醫(yī)藥現(xiàn)代化專項（2023YFC3504101）;國家中醫(yī)藥管理局應(yīng)用基礎(chǔ)研究課題（gzyjc20210901）