中药无机元素的组成与含量受种植环境、炮制工艺等多因素影响，其中有害重金属元素与有益微量元素分别决定用药安全与药效活性，是中药质量管控的核心关键指标。系统检索2020—2026年中国学术期刊全文数据库（CNKI）、PubMed数据库近5年相关研究文献，以电感耦合等离子体质谱（ICP-MS）无机元素指纹谱为核心，梳理其在中药材产地溯源、真伪鉴别、制剂一致性评价、炮制工艺优化等方面的应用进展，阐明化学计量学和机器学习在复杂元素谱数据挖掘中的应用价值。同时，系统归纳暴露评估、风险表征及限量推导等多层次中药无机元素健康风险评估方法，对比各国药典重金属限量标准差异，剖析药食同源品种药品与食品双重标准冲突、元素总量模式无法区分不同形态元素的毒性差异、本土化暴露评估参数体系不完善等现存难题。基于现有研究短板，提出未来研究应完善中药无机元素形态检测标准体系、构建基于真实世界用药规律的本土化暴露参数、建立基于预期用途分类管理的限量体系，实现中药从种植、炮制、制剂到临床应用全链条无机元素智慧化质量管控，为中药科学监管、质量标准完善与国际化发展提供理论与技术参考。

The composition and content of inorganic elements in traditional Chinese medicine (TCM) are influenced by multiple factors, including cultivation environment and processing techniques. Among these, harmful heavy metals and beneficial trace elements determine drug safety and pharmacological efficacy, making them key indicators for TCM quality control. This study systematically reviewed relevant research published between 2020 and 2026 from the China National Knowledge Infrastructure (CNKI) and PubMed databases. Focusing on inorganic elemental fingerprinting via inductively coupled plasma mass spectrometry (ICP-MS), it summarizes recent advances in applications such as geographical origin tracing, authenticity identification, consistency evaluation of formulations, and optimization of processing methods. It also highlights the value of chemometrics and machine learning in mining complex elemental spectral data. Furthermore, the study systematically outlines multi-tiered health risk assessment approaches for inorganic elements in TCM, including exposure assessment, risk characterization, and threshold derivation. It compares differences in heavy metal limit standards across national pharmacopoeias, analyzes existing challenges—such as conflicts between dual regulatory standards for food-medicine homologous species, the inability of total elemental concentrations to distinguish toxicological differences among element speciation, and incomplete localized exposure assessment parameters—and proposes future research directions. Based on current research gaps, it recommends improving standardized methods for detecting TCM inorganic element speciation, establishing localized exposure parameters based on real-world usage patterns, and developing a classification-based limit system according to intended uses. These measures aim to achieve intelligent, end-to-end quality control of inorganic elements throughout the entire TCM supply chain—from cultivation and processing to formulation and clinical application—providing theoretical and technical support for scientific regulation, quality standard refinement, and international development of TCM.

R284.1

药品监管科学全国重点实验室课题（2025SKLDRS0343）