Risk assessment method for heavy metals in traditional Chinese medicinal materials

Abstract

The invention relates to the technical field of traditional Chinese medicinal materials, in particular to a method for risk assessment of heavy metals in traditional Chinese medicinal materials. According to the method, heavy metal content data of a traditional Chinese medicine sample is acquired and preprocessed to establish an evaluation model comprising a risk grading module and a comprehensive risk scoring module, and human body exposure is calculated by considering factors such as use frequency, exposure age limit, daily dose and transfer rate of traditional Chinese medicine; and comparing the exposure quantity with a preset health reference value to obtain a single heavy metal risk index, performing weighted calculation by combining the single heavy metal risk index with traditional Chinese medicinal material characteristic parameters (clinical use frequency, average prescription dosage, decoction extraction mode, use crowd range and medicinal part) to obtain a comprehensive risk score, and performing five-level risk grade division and evaluation report generation based on the score. The method breaks through the limitation of traditional binary evaluation, establishes a multi-dimensional risk evaluation system, considers the synergistic effect between heavy metals and the characteristic influence of traditional Chinese medicines, and provides important technical support for guaranteeing the use safety of traditional Chinese medicines and the healthy development of the traditional Chinese medicine industry.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicinal materials, and in particular to a method for heavy metal risk assessment in Chinese medicinal materials. Background Art

[0002] As an integral part of traditional medicine, the safety assessment of Chinese medicinal materials (TCMs) is crucial for safeguarding public health. With advances in modern analytical techniques, heavy metal contamination in TCMs is a growing concern. Heavy metals such as lead, arsenic, mercury, and cadmium are bioaccumulative and potentially toxic, and can enter TCMs through various pathways, including agricultural environmental pollution, processing, preparation, and storage conditions. International organizations such as the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO) have established risk assessment as the scientific basis for establishing drug safety standards. Traditional heavy metal risk assessments in TCMs primarily rely on a single limit standard approach, which simply compares the heavy metal content with the limit standard to determine compliance. In recent years, assessment methods based on exposure calculations have been increasingly applied to TCM safety research. For example, CN111861183A proposes a method for heavy metal risk assessment in TCMs. This method incorporates the concept of transfer rate and takes into account the characteristics of TCM usage, making it more scientifically sound than a simple limit standard.

[0003] However, existing assessment methods still have many limitations: First, most assessment systems are overly simplified, considering only the risk index of a single heavy metal and ignoring the possible synergistic or antagonistic effects between multiple heavy metals. Second, assessment results are usually judged in a binary manner (high risk or low risk), lacking a more refined risk grading system, which is not conducive to differentiated management. Third, the assessment process does not fully consider the characteristic parameters of Chinese medicinal materials, such as clinical use frequency, prescription dosage, and medicinal site, resulting in deviations between the assessment results and actual clinical application scenarios. Finally, existing methods are usually limited to risk assessment itself and lack a systematic risk assessment report generation mechanism and data accumulation and feedback system, making it difficult to form a long-term risk control closed loop. These shortcomings have restricted the precise and intelligent development of heavy metal risk management in Chinese medicinal materials, and there is an urgent need to establish a more comprehensive, refined, and systematic risk assessment method. Summary of the Invention

[0004] In view of the problems existing in the prior art, the present invention is proposed.

[0005] Therefore, the problem to be solved by the present invention is how to address technical issues in existing technologies such as oversimplification of heavy metal risk assessment, lack of refined grading, failure to consider the characteristic parameters of traditional Chinese medicines, and lack of a systematic assessment report generation mechanism. This method establishes a heavy metal risk assessment model and performs weighted calculations based on the characteristic parameters of traditional Chinese medicines. This method achieves the transformation from a single heavy metal risk index to a comprehensive risk score. Based on this, a multi-level risk grading system is established, which in turn generates a detailed assessment report, providing a scientific basis for the quality control and safe use of traditional Chinese medicines.

[0006] In order to solve the above technical problems, the present invention provides the following technical solutions: In a first aspect, an embodiment of the present invention provides a method for heavy metal risk assessment in traditional Chinese medicine, comprising obtaining heavy metal content data of a traditional Chinese medicine sample, and preprocessing the heavy metal content data to obtain standardized heavy metal content data; Establishing a heavy metal risk assessment model, wherein the heavy metal risk assessment model includes a risk level classification module and a comprehensive risk scoring module; Calculate the human exposure to heavy metals based on the frequency of use of Chinese medicinal materials, years of exposure, daily dosage, transfer rate, and heavy metal content data; Comparing the human exposure amount with the preset heavy metal health reference value to obtain a risk index for a single heavy metal; A comprehensive risk score is obtained by performing a weighted calculation based on the risk index of the single heavy metal and the characteristic parameters of the Chinese medicinal materials; Based on the comprehensive risk score, the health risks of heavy metals in the Chinese medicinal materials are graded and an assessment report is generated.

[0007] As a preferred embodiment of the method for heavy metal risk assessment in traditional Chinese medicines of the present invention, the heavy metal content data includes content data of lead, arsenic, mercury, cadmium and copper.

[0008] As a preferred embodiment of the method for risk assessment of heavy metals in traditional Chinese medicines of the present invention, the calculation of human exposure takes into account the following factors: Frequency of use refers to the number of days per year that the Chinese herbal medicine is taken; years of exposure refers to the cumulative number of years of long-term use of the Chinese herbal medicine; The daily dosage is the number of grams of the Chinese herbal medicine taken per day; the transfer rate is the percentage of heavy metals in the Chinese herbal medicine transferred to the decoction through decoction or other treatment methods; Average human weight and average life expectancy.

[0009] As a preferred embodiment of the method for heavy metal risk assessment in traditional Chinese medicines of the present invention, the preset heavy metal health reference values ​​include: For heavy metals with health-related guidance values, use their officially published health-related guidance values; For heavy metals that do not have official health guidance values, their lower benchmark dose limits shall be used.

[0010] As a preferred embodiment of the method for heavy metal risk assessment in traditional Chinese medicines of the present invention, the method for calculating the risk index of a single heavy metal includes: When heavy metals have health guidance values, the risk index is equal to the ratio of human exposure to the health guidance value multiplied by the safety factor; When heavy metals do not have health guidance values, the risk index is equal to the inverse of the ratio of the lower limit of the benchmark dose to the human exposure multiplied by the safety factor.

[0011] As a preferred embodiment of the method for heavy metal risk assessment in traditional Chinese medicines of the present invention, the characteristic parameters of the traditional Chinese medicines include: The frequency of clinical use of Chinese medicinal materials; the average prescription dose of Chinese medicinal materials; the decoction and extraction methods of Chinese medicinal materials; the range of people who use Chinese medicinal materials; and the medicinal parts of Chinese medicinal materials.

[0012] As a preferred embodiment of the method for heavy metal risk assessment in traditional Chinese medicines of the present invention, the calculation of the comprehensive risk score includes: Assign a weight coefficient to each heavy metal risk index; sum up the weighted heavy metal risk indices; The total risk is adjusted according to the characteristic parameters of Chinese medicinal materials to obtain the final comprehensive risk score.

[0013] As a preferred embodiment of the method for heavy metal risk assessment in traditional Chinese medicines of the present invention, the risk level classification module classifies the risk levels into the following types according to the comprehensive risk score: Low risk: comprehensive risk score is less than or equal to 0.5; medium-low risk: comprehensive risk score is greater than 0.5 and less than or equal to 0.8; Medium risk: comprehensive risk score greater than 0.8 and less than or equal to 1.2; Medium-high risk: comprehensive risk score greater than 1.2 and less than or equal to 2.0; High risk: The overall risk score is greater than 2.0.

[0014] As a preferred embodiment of the method for heavy metal risk assessment in traditional Chinese medicines of the present invention, the generation of the assessment report includes: Basic information of Chinese herbal medicine samples; heavy metal content and comparison with limit standards; human exposure and risk index of each heavy metal; Comprehensive risk score and risk level; risk management recommendations and safe usage tips.

[0015] As a preferred embodiment of the method for heavy metal risk assessment in Chinese medicinal materials described in the present invention, it further includes constructing a heavy metal risk database for Chinese medicinal materials, wherein the database stores historical assessment results and risk trend analysis for reference in future risk warnings and the formulation of quality control standards for Chinese medicinal materials.

[0016] In a second aspect, an embodiment of the present invention provides a system for heavy metal risk assessment in traditional Chinese medicines, which includes a data acquisition module. The system acquires heavy metal content data of traditional Chinese medicine samples and pre-processes the heavy metal content data to obtain standardized heavy metal content data. Constructing a module to establish a heavy metal risk assessment model, wherein the heavy metal risk assessment model includes a risk level classification module and a comprehensive risk scoring module; The calculation module calculates the human exposure to heavy metals based on the frequency of use of Chinese medicinal materials, years of exposure, daily dosage, transfer rate and heavy metal content data; A comparison module compares the human exposure amount with a preset heavy metal health reference value to obtain a risk index for a single heavy metal; A weighting module performs weighted calculation based on the risk index of the single heavy metal and the characteristic parameters of the Chinese medicinal materials to obtain a comprehensive risk score; The result output module classifies the health risks of heavy metals in the Chinese medicinal materials and generates an assessment report based on the comprehensive risk score.

[0017] In a third aspect, an embodiment of the present invention provides a computer device comprising a memory and a processor, wherein the memory stores a computer program, wherein: when the computer program instructions are executed by the processor, the steps of the method for heavy metal risk assessment in traditional Chinese medicines as described in the first aspect of the present invention are implemented.

[0018] In a fourth aspect, an embodiment of the present invention provides a computer-readable storage medium having a computer program stored thereon, wherein: when the computer program instructions are executed by a processor, the steps of the method for heavy metal risk assessment in traditional Chinese medicines as described in the first aspect of the present invention are implemented.

[0019] The present invention has the following beneficial effects: First, it breaks through the limitations of traditional binary judgment and establishes a five-level risk classification system, enabling refined risk management and making assessment results more practical and targeted. Based on different risk levels, corresponding control measures can be formulated to achieve hierarchical and precise risk management.

[0020] Secondly, by incorporating characteristic parameters such as the frequency of clinical use of TCM materials, average prescription dosage, decoction and extraction method, user population, and medicinal parts, the assessment results are more closely aligned with clinical reality. This innovative parameter weighting mechanism overcomes the shortcomings of traditional methods that focus solely on heavy metal content and transfer rate, significantly improving the accuracy and practical value of the assessment.

[0021] Furthermore, by comprehensively considering the synergistic effects of multiple heavy metals, the study overcomes the limitations of traditional methods that assess the risk of each heavy metal individually. By weighting and summarizing different heavy metal risk indices, the study provides a more comprehensive picture of the overall risk profile of Chinese medicinal materials, avoiding the potential for underestimation or overestimation of risk due to a single indicator.

[0022] Furthermore, the present invention establishes a standardized assessment report generation mechanism, providing differentiated risk information and management recommendations based on the specific user. This targeted information delivery method improves the effectiveness of risk communication and promotes scientific and rational drug use.

[0023] Finally, by constructing a heavy metal risk database for traditional Chinese medicines, we achieved the systematic storage, analysis, and utilization of assessment results. This data-driven risk management model supports dynamic monitoring and early warning of risk trends, promoting the transition of the traditional Chinese medicine industry from passive response to active prevention and control, and providing a scientific basis for the formulation of quality standards for traditional Chinese medicines and industry optimization.

[0024] In summary, the heavy metal risk assessment method in traditional Chinese medicines provided by the present invention is significantly superior to the existing technology in terms of scientificity, comprehensiveness, accuracy and practicality, and provides important technical support for ensuring the safety of traditional Chinese medicines and promoting the healthy development of the traditional Chinese medicine industry. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0026] Figure 1 A flow chart of the method for risk assessment of heavy metals in Chinese herbal medicines; Figure 2 Computer equipment diagram for the method of heavy metal risk assessment in Chinese herbal medicines; Figure 3 Schematic diagram of the system structure of the method for heavy metal risk assessment in traditional Chinese medicine. DETAILED DESCRIPTION

[0027] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the specific embodiments of the present invention are described in detail below with reference to the accompanying drawings.

[0028] In the following description, many specific details are set forth to facilitate a full understanding of the present invention. However, the present invention may also be implemented in other ways different from those described herein. Those skilled in the art may make similar generalizations without violating the connotation of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0029] Secondly, the term "one embodiment" or "embodiment" herein refers to a specific feature, structure, or characteristic that may be included in at least one implementation of the present invention. The phrase "in one embodiment" appearing in various places throughout this specification does not necessarily refer to the same embodiment, nor does it constitute a separate or selective embodiment that is mutually exclusive with other embodiments.

[0030] Example 1 Reference Figures 1 and 2 , which is the first embodiment of the present invention, provides a method for heavy metal risk assessment in traditional Chinese medicines, comprising: S100: Obtaining heavy metal content data of a Chinese medicinal material sample, and preprocessing the heavy metal content data to obtain standardized heavy metal content data; S200: Establish a heavy metal risk assessment model, which includes a risk level classification module and a comprehensive risk scoring module; S300: Calculate human exposure to heavy metals based on the frequency of use, exposure years, daily dosage, transfer rate, and heavy metal content of Chinese herbal medicines; S400: Compare the human exposure amount with the preset heavy metal health reference value to obtain the risk index of a single heavy metal; S500: A comprehensive risk score is obtained by weighted calculation based on the risk index of a single heavy metal and the characteristic parameters of traditional Chinese medicines; S600: Based on the comprehensive risk score, the health risks of heavy metals in traditional Chinese medicines are graded and an assessment report is generated.

[0031] The present invention's heavy metal risk assessment method for Chinese medicinal materials, constructed through steps S100-S600, aims to address several key issues in existing assessment technologies. Traditional heavy metal risk assessment for Chinese medicinal materials primarily relies on a single limit standard method, simply comparing heavy metal content with the limit standard value, lacking a systematic approach. While existing technologies, such as CN111861183A, introduce the concept of transfer rate, they still suffer from numerous limitations: First, the assessment results are overly simplified, typically considering only a single heavy metal risk index and ignoring the overall toxicity effect; second, they lack a refined risk grading system, relying solely on a binary judgment (high risk or low risk), which is not conducive to differentiated management; third, they fail to fully consider the impact of the Chinese medicinal material's inherent characteristic parameters on risk; and fourth, they lack a systematic assessment report generation mechanism and data accumulation system. This invention establishes a heavy metal risk assessment model that combines risk grading with a comprehensive risk score, achieving a transition from a single heavy metal risk index to a comprehensive risk score. This score is then used to perform a multi-level risk grading and generate a detailed assessment report. This method not only takes into account basic factors such as heavy metal transfer rate and human exposure, but also introduces characteristic parameters of Chinese medicinal materials for weighted calculation, forming a comprehensive, accurate and practical risk assessment system, providing a scientific basis for the quality control and safe use of Chinese medicinal materials.

[0032] The present invention obtains heavy metal content data from Chinese herbal medicine samples and establishes a risk assessment model that includes a risk level classification module and a comprehensive risk scoring module. The human exposure is calculated by considering factors such as the frequency of use of Chinese herbal medicines, years of exposure, daily dosage, and transfer rate. The exposure is compared with the preset health reference value to obtain a single heavy metal risk index. The comprehensive risk score is then weighted and calculated in combination with the characteristic parameters of the Chinese herbal medicines to obtain a comprehensive risk score. Finally, the level classification and assessment report generation are performed based on the score. This complete assessment process breaks through the limitations of traditional binary assessment and establishes a multi-dimensional, multi-level risk assessment system. The technical solution of claim 1 achieves refined management of risk assessment by combining the characteristic parameters of Chinese herbal medicines with the heavy metal risk index, making the assessment results more in line with actual clinical application scenarios. At the same time, by introducing a comprehensive risk scoring mechanism, the problem of ignoring the synergistic or antagonistic effects of multiple heavy metals is solved. The method of claim 1 can not only accurately identify high-risk Chinese herbal medicines, but also provide corresponding treatment suggestions based on the risk level, such as low-risk Chinese herbal medicines can be used normally, medium-risk Chinese herbal medicines require appropriate reduction or restriction of use time, and high-risk Chinese herbal medicines may require changing the source of the Chinese herbal medicine or taking additional treatment measures. In addition, the automatic generation function of the assessment report improves the practicality and operability of risk assessment, helps regulatory authorities, production companies and clinical physicians make scientific and reasonable decisions, thereby ensuring the safety of the use of Chinese medicinal materials, and has significant social benefits and application value.

[0033] Example 2 Reference Figure 1-Figure 3For the second embodiment of the present application.

[0034] In the embodiment of the present application, the heavy metal content data of the traditional Chinese medicinal material sample is acquired in step S100, and the heavy metal content data is preprocessed to obtain standardized heavy metal content data, including the following steps A1-A2: A1: The heavy metal content data includes the content data of lead, arsenic, mercury, cadmium and copper.

[0035] A1: According to the heavy metal detection method specified in the Chinese Pharmacopoeia, collect not less than 500g of representative sample of the target traditional Chinese medicinal material, after pretreatment such as crushing, sieving and drying, use inductively coupled plasma mass spectrometry (ICP-MS) to determine the content of five heavy metals of lead, arsenic, mercury, cadmium and copper in the sample. ICP-MS has the advantages of low detection limit, wide linear range and simultaneous analysis of multiple elements. During the detection process, national standard materials are used for calibration to ensure data accuracy. At the same time, method blank and sample blank are used to correct environmental background interference. 5% blind sample is added during analysis of each batch of samples for quality control, and the relative standard deviation of repeated determination is controlled within 5%. For samples with abnormal detection results, atomic fluorescence spectrometry (AFS) or atomic absorption spectrometry (AAS) is used for cross verification to ensure data reliability.

[0036] A2: The acquired heavy metal content data is subjected to data cleaning and standardization processing. Data cleaning includes identifying outliers, using Grubbs method to test whether the data points are outliers, and performing secondary detection confirmation or removing the confirmed outliers; supplementing missing values, using median or similar sample average to estimate; eliminating systematic errors, through standard curve correction and instrument drift correction methods. The standardization processing uses Z-score standardization method, that is:

[0037] Wherein, is the standardized value, is the original detection value, μ is the historical average value of the same traditional Chinese medicinal material, and σ is the standard deviation. This standardization method makes the content data of different heavy metals comparable, facilitating the construction of subsequent risk assessment model.

[0038] Specifically, in A1, the Chinese medicinal material samples are first strictly sampled and prepared, including random sampling, uniform mixing, and quartering to ensure the representativeness of the samples. During sample pretreatment, the samples are dried to constant weight at 60°C, ground into 80-mesh powder, and digested by microwave digestion. Usually, an HNO3-H2O2 system is used for complete digestion. The digestion temperature is controlled at 180-200°C and the duration is about 30 minutes. For volatile elements such as mercury, a closed digestion system is used to prevent volatilization losses. During ICP-MS detection, appropriate mass numbers are selected for different heavy metals, such as m / z 75 for arsenic, m / z 208 for lead, m / z 202 for mercury, m / z 111 and 114 for cadmium, and m / z 63 and 65 for copper. Dynamic reaction cell or collision cell technology is used to eliminate possible polyatomic ion interference.

[0039] In A2, in addition to Z-score normalization, the Min-Max normalization method can also be used to map the data to the [0, 1] interval:

[0040] Among them, X is the original detection value, and These are the minimum and maximum values ​​of historical data for similar Chinese medicinal materials, respectively. This normalization process is particularly applicable to scenarios where threshold judgments are used in assessment models. After data normalization, the following comprehensive pollution index can also be calculated based on the toxicity mechanism and biological significance of heavy metals:

[0041] Among them, Cd, Pb, As, Hg, and Cu are the detection values ​​of each heavy metal, and Sd, Sp, Sa, Sh, and Sc are the standard limit values ​​of each heavy metal. A PI > 1 indicates that the heavy metal contamination of the Chinese medicinal material exceeds the standard, and a larger PI indicates a more serious degree of contamination.

[0042] In an alternative embodiment, a portable X-ray fluorescence spectrometer (XRF) can be used for rapid screening of heavy metals in traditional Chinese medicines. This method requires no complex sample pretreatment, allows for on-site testing, and is fast (approximately 2-5 minutes per sample), making it suitable for initial screening of large batches of samples. Samples whose screening results exceed the warning value are then subjected to precise quantitative analysis using ICP-MS, forming a two-tiered detection strategy of "rapid screening + precise quantification," ensuring both efficient and reliable results.

[0043] In another alternative embodiment, chemical speciation analysis techniques, such as high performance liquid chromatography-inductively coupled plasma mass spectrometry (HPLC-ICP-MS), can be used to distinguish different chemical forms of heavy metals, such as inorganic arsenic (As 3+ 、As5 + ) and organic arsenic (such as arsenic acid and dimethylarsenic acid), inorganic mercury, and methylmercury. The toxicity of different forms of heavy metals varies significantly. For example, inorganic arsenic is much more toxic than organic arsenic, and methylmercury is more toxic than inorganic mercury. Speciation analysis can provide more accurate risk assessment information. Although complex and costly, it is invaluable for in-depth analysis of high-risk samples.

[0044] In the embodiment of the present application, a heavy metal risk assessment model is established in step S200. The heavy metal risk assessment model includes a risk level classification module and a comprehensive risk scoring module, including the following steps B1-B3: B1: Construct a risk classification module. Based on the relevant literature on heavy metal health risks and the risk assessment guidelines of international organizations, a five-level risk classification standard is designed. This module uses a comprehensive risk score as input and outputs the corresponding risk level through threshold judgment. The five risk levels include: low risk (score ≤ 0.5), medium-low risk (0.5 < score ≤ 0.8), medium risk (0.8 < score ≤ 1.2), medium-high risk (1.2 < score ≤ 2.0) and high risk (score > 2.0). Each risk level corresponds to different management measures and usage recommendations. For example, low risk can be used normally, medium-low risk requires attention to dosage, medium risk requires shortening the use time, medium-high risk recommends choosing alternative medicinal materials, and high risk should not be used.

[0045] B2: Construct a comprehensive risk scoring module. This module is designed based on a multi-factor weighted cumulative model, taking into account the synergistic effects of multiple heavy metals and the modifying effects of TCM characteristic parameters. The module input includes the risk index of each heavy metal and the characteristic parameters of TCM, and the output is a comprehensive risk score between 0 and 5. The score is calculated using a weighted summation method, namely:

[0046] in, is the weight coefficient of the i-th heavy metal, is the risk index of the i-th heavy metal, and K is the adjustment coefficient for the characteristic parameters of the Chinese herbal medicine. The weighting coefficient is determined based on the toxicity of the heavy metal. Typically, the weighting ratio for lead, arsenic, mercury, cadmium, and copper is approximately 3:3:3:2:1. The specific value can be fine-tuned based on the type of Chinese herbal medicine and its intended use.

[0047] B3: Through model validation and calibration, the model was trained and verified using an existing heavy metal risk assessment dataset. 500 samples of commonly used Chinese medicinal herbs were selected, along with their heavy metal content data and expert-assessed risk levels, as the training set. Cross-validation was used to evaluate model performance, focusing on sensitivity and specificity. Sensitivity refers to the ability to correctly identify high-risk samples, while specificity refers to the ability to correctly identify low-risk samples. By adjusting model parameters, the model achieved an accuracy exceeding 90%, with both sensitivity and specificity exceeding 85%.

[0048] Specifically, in B1, the five-level risk classification is designed with reference to the risk management frameworks of multiple international organizations, such as the World Health Organization (WHO)'s Guidelines for Chemical Risk Assessment and the Food Safety Risk Analysis Principles of the Food and Agriculture Organization of the United Nations (FAO). In addition to corresponding usage recommendations, each risk level is also associated with corresponding regulatory measures. For example, low-risk Chinese medicinal materials can be subject to simplified quality control processes; medium- and low-risk materials require increased sampling frequency; medium-risk materials require process improvement research, such as adding water-flying treatment to reduce heavy metal content; medium- and high-risk materials require the establishment of a strict traceability system to ensure the controllable source of raw materials; and high-risk materials require suspension of use and the initiation of risk intervention research.

[0049] In B2, the design of the comprehensive risk scoring module takes into account the interactions between heavy metals. Studies have shown that certain heavy metal combinations can produce synergistic toxic effects, such as the combined toxicity of arsenic and cadmium, which is greater than the sum of their individual effects. Some combinations can also produce antagonistic effects, such as the antagonistic effect of selenium on mercury toxicity. Therefore, interaction terms are introduced into the score calculation:

[0050] in, is the interaction coefficient between heavy metals i and j, is the risk index of the jth heavy metal, K is the adjustment coefficient of the characteristic parameters of Chinese medicinal materials, when When >0, it indicates synergistic effect. When < 0, it indicates an antagonistic effect. This complex model requires a large amount of data support and can be simplified to a weighted sum model when data is insufficient.

[0051] In B3, model validation utilizes both statistical indicators and clinical relevance. 100 cases of adverse reactions reported after using heavy metal-containing Chinese medicinal herbs were selected, and the consistency between the model's risk scores and actual clinical manifestations was analyzed. Cases where the model misjudged adverse reactions were analyzed in depth to identify possible causes, such as sensitivity in specific populations and differences in medication usage, to further refine the model. Furthermore, a regular model update mechanism was established, with model parameters calibrated annually based on new data and research progress to ensure the timeliness and accuracy of the evaluation results.

[0052] It should be noted that the construction of the risk assessment model needs to balance scientific rigor and practicality. A too complex model may be more accurate in theory, but too many parameters will increase uncertainty and make it difficult to promote in practical applications. This model adopts the design concept of "simple but not simple", the core calculation logic is clear, and enough flexibility is retained to adapt to different situations.

[0053] In an alternative embodiment, a machine learning method can be used to construct the risk assessment model. By collecting a large amount of data on heavy metal content in traditional Chinese medicinal materials and related toxicology research results, a nonlinear classification model is established using algorithms such as random forest or support vector machine. This method does not require prior assumptions about the relationship between risk factors, can automatically identify complex interaction patterns, and is particularly suitable for handling risk assessment problems with multiple variables and nonlinear relationships. As data accumulates, the model can learn and optimize itself, continuously improving prediction accuracy.

[0054] In another alternative embodiment, a probabilistic risk assessment model can be constructed based on Bayesian networks. This method represents risk factors and outcome variables as nodes in the network, and represents the dependence between nodes through conditional probability. The advantage of this method is that it can explicitly express the causal relationship between variables, intuitively show the risk transmission path, and handle the uncertainty of data, providing a confidence interval for the risk assessment result, allowing decision-makers to have a more comprehensive understanding of the potential risk range, and is suitable for risk assessment of complex systems.

[0055] In the embodiments of the present application, in step S300, the human body exposure of heavy metals is calculated according to the usage frequency, exposure years, daily dosage, transfer rate and heavy metal content data of traditional Chinese medicinal materials, including the following steps C1: C1: The calculation of human body exposure takes the following factors into account: The usage frequency represents the number of days per year that the traditional Chinese medicinal material is taken; the exposure years represent the cumulative number of years of long-term use of the traditional Chinese medicinal material; The daily dosage represents the number of grams of the traditional Chinese medicinal material taken per day; the transfer rate represents the percentage of heavy metals in the traditional Chinese medicinal material that is transferred to the decoction through processing methods such as decoction; The average body weight of humans and the average life span in days.

[0056] C1: Collect TCM usage parameters, including frequency of use (EF), exposure duration (ED), daily dose (IR), average body weight (BW), and average lifespan (AT). The frequency of use is based on survey data on TCM clinical use patterns, with 90 days / year being the standard frequency. For long-term use of TCM for chronic diseases, 180 days / year can be used. The exposure duration is set at 20 years to account for long-term use. The daily dose is determined based on the type of TCM and the recommended dose in the pharmacopoeia, usually ranging from 3 to 30 g / day. The average body weight is based on the Chinese adult standard weight of 60 kg. The average lifespan is calculated as 70 years, or 25,550 days.

[0057] C2: Determine the heavy metal transfer rate (TR), that is, the percentage of heavy metals in Chinese medicinal materials transferred to the decoction after decoction and other treatments. For different heavy metals, their transfer rates were determined through simulated decoction experiments: standard Chinese medicinal material samples were prepared into decoctions according to the commonly used clinical method (decoction twice, each time for 30 minutes), and the heavy metal content in the raw medicinal materials and decoctions was measured respectively, and the transfer percentage was calculated. According to experimental data, the average transfer rates of lead, cadmium, arsenic, mercury, and copper were 14%, 14%, 35%, 24%, and 15%, respectively. However, it should be noted that different types of Chinese medicinal materials, decoction methods, and excipients may lead to differences in transfer rates.

[0058] C3: Apply the human exposure calculation formula and integrate the above parameters to calculate the average daily exposure (ADD) of each heavy metal in μg / kg bw / day:

[0059] Where C is the heavy metal content in the TCM (mg / kg), IR is the daily dose (g / day), EF is the frequency of use (day / year), ED is the exposure period (year), TR is the transfer rate (%), BW is the average body weight (kg), and AT is the average lifespan (day). This formula takes into account the characteristics of TCM use, averaging short-term high-dose exposure over the entire lifespan, consistent with the principles of long-term risk assessment.

[0060] Specifically, in C1, the determination of TCM usage parameters requires comprehensive consideration of differences across different populations and disease types. Frequency of use can be determined based on the clinical application of TCM: warming and tonic herbs such as ginseng and astragalus may be taken long-term by patients with chronic conditions, with a usage frequency of up to 250 days per year; heat-clearing and detoxifying herbs such as coptis chinensis and honeysuckle are primarily used for acute conditions, with a typical usage frequency of 30-60 days per year; and commonly used conditioning herbs such as cassia seed and hawthorn are used approximately 90-120 days per year. Exposure duration can also be adjusted based on the user population: elderly patients with chronic diseases may require lifelong use of certain TCMs, with an exposure duration of up to 30 years; while 20 years is a reasonable estimate for the general population. These parameters can be assessed using actual data collected through hospital prescription statistics and medication questionnaires to improve assessment accuracy.

[0061] In C2, a standardized experimental protocol is required for the determination of heavy metal transfer rates. The standard experimental conditions are: a 1:10 herbal medicine to water ratio, 30 minutes for the first decoction, 20 minutes for the second decoction, and the two decoctions combined. Studies have shown that transfer rates are affected by multiple factors: higher decoction temperatures increase transfer rates; longer decoction times increase transfer rates but gradually level off; lower pH values ​​(e.g., by adding vinegar) increase transfer rates for certain heavy metals; and finer herbal pulverization increases transfer rates. Therefore, when evaluating specific Chinese herbal medicines, transfer rate values ​​should be adjusted based on their actual usage. For example, the transfer rate of heavy metals in acidic formulas (e.g., Wumei Decoction) may be 10%–20% higher than in neutral formulas; and the transfer rate of decoctions that require prolonged cooking (e.g., Siwu Decoction) may be 15%–25% higher than that of rapidly cooked decoctions.

[0062] In C3, human exposure calculation can be further refined into two dimensions: acute exposure assessment and chronic exposure assessment. Acute exposure assessment focuses on single or short-term (1-14 days) high-dose medication, and is suitable for assessing the acute toxicity risks that may be brought about by short-acting Chinese medicines:

[0063] AADD = (C × IR_max × TR) / (BW) in, The maximum daily dose is typically 1.5 times the upper limit of the recommended dose in pharmacopoeias. This calculation is suitable for assessing the risk of acutely toxic heavy metals such as arsenic. Chronic exposure assessment uses a standard formula to estimate the cumulative risk associated with long-term use of traditional Chinese medicines. It is suitable for assessing cumulatively toxic heavy metals such as lead and cadmium. Combining these two assessment methods provides a more comprehensive risk picture.

[0064] It should be noted that calculating human exposure is a core step in risk assessment and directly impacts the accuracy of the final assessment results. Parameter selection should adhere to the principle of "reasonable maximum exposure," meaning conservative parameters should be chosen within a scientifically reasonable range to avoid underestimating risk. Furthermore, due to significant individual variability, calculated results should be considered as group averages, and population-specific adjustment factors should be considered when used in individual risk assessments.

[0065] In an alternative implementation, a probabilistic exposure assessment approach can be employed, treating each input parameter as a random variable with a defined distribution rather than a single, fixed value. For example, the frequency of use can be represented as a normal distribution with a mean of 90 days / year and a standard deviation of 30 days / year; the daily dose can be represented as a triangular distribution with a minimum, most likely, and maximum value. Monte Carlo simulations, through extensive random sampling and calculations, yield a probabilistic distribution of exposure, providing information on the uncertainty and variability of risk, and more comprehensively supporting risk management decisions.

[0066] In another optional embodiment, a physiologically based pharmacokinetic (PBPK) model can be established to simulate the absorption, distribution, metabolism and excretion of heavy metals in the human body. This method takes into account the distribution dynamics and accumulation characteristics of heavy metals in different tissues and organs, and can predict the concentration of heavy metals in target organs under long-term exposure, and more accurately assess health risks. Although this method is highly complex and requires a large amount of toxicological data support, it is of great value for the in-depth evaluation of high-risk Chinese medicinal materials.

[0067] In the embodiment of the present application, step S400 compares the human body exposure with the preset heavy metal health reference value to obtain the risk index of a single heavy metal, including the following steps D1-D2: D1: For heavy metals with health guidance values, use the officially published health guidance values; D2: For heavy metals without official health guidance values, use their lower benchmark dose limit.

[0068] D1: Determine health-based reference values ​​for each heavy metal, including health-based guidance values ​​(HBGVs) and benchmark lower dose limits (BMDLs). Health-based guidance values ​​are derived from safety limits published by international organizations such as the World Health Organization (WHO), the Food and Agriculture Organization of the United Nations (FAO), and the European Food Safety Authority (EFSA), such as the tolerable daily intake (TDI), tolerable weekly intake (PTWI), or reference dose (RfD). For heavy metals without official health-based guidance values, the benchmark lower dose limit (BMDL) is used as the health-based reference value. The BMDL is the 95% confidence limit for the exposure that causes a specific adverse effect. For example, the BMDL01 (cardiovascular effects) for lead is 1.5 μg / kg·bw / day, the BMDL0.5 (lung cancer) for arsenic is 3.0 μg / kg·bw / day, the PTMI (renal effects) for cadmium is 25 μg / kg·bw / month, the PTWI (neurological effects) for mercury is 4 μg / kg·bw / week, and the PMTDI (liver effects) for copper is 500 μg / kg·bw / day.

[0069] D2: Calculate the risk index (RI), which reflects the ratio of actual exposure to health reference values. Different calculation methods are used depending on the type of health reference value: For heavy metals with health guidance values:

[0070] Among them, ADD is the average daily exposure, SF is the safety factor (usually 10, indicating that the acceptable exposure of traditional Chinese medicine should not exceed 10% of the total exposure), and HBGV is the health guidance value standardized to daily intake.

[0071] For heavy metals with only lower benchmark dose limits:

[0072] Among them, BMDL is the lower limit of the benchmark dose.

[0073] When RI ≤ 1, the heavy metal exposure is within the safe range and the risk is low. When RI > 1, the heavy metal exposure exceeds the safety threshold and the risk is high. The risk index not only provides a risk level assessment but also quantifies the degree of risk, facilitating risk comparisons between different Chinese medicinal materials or heavy metals.

[0074] Specifically, in D1, the selection of health-based reference values ​​(HBVs) should consider the latest toxicological research advances and international assessments. For lead, traditional assessments used a PTWI of 25 μg / kg·bw / week. However, the WHO withdrew this value in 2011, concluding that no safety threshold exists for lead. The BMDL01 is now commonly used as a reference value. For arsenic, distinguishing between inorganic and organic arsenic is crucial, with assessments primarily focusing on the more toxic inorganic form. For cadmium, the EFSA lowered the tolerable weekly intake (TWI) from 7 μg / kg·bw to 2.5 μg / kg·bw in 2012, reflecting a reassessment of its long-term cumulative risk. For mercury, a distinction should be made between inorganic mercury and methylmercury, the latter being more toxic and enriched in aquatic organisms. This requires particular attention for traditional Chinese medicines containing aquatic sources. For copper, although an essential trace element, it can still be toxic at high doses, necessitating a balance between essentiality and safety.

[0075] In D2, the safety factor (SF) used in the risk index calculation must take into account the contribution of traditional Chinese medicine (TCM) to heavy metals in the daily diet. Studies have shown that for most people, the main sources of heavy metals in the diet are staple foods and specific foods (such as mercury in seafood and arsenic in starchy foods), with TCM typically contributing no more than 10%. However, for specific populations who take TCM for a long time and in large doses, this proportion may reach 20% to 30%. Therefore, the safety factor can be adjusted based on the characteristics of the medication population: SF = 10 is used for the general population; SF = 5 can be used for chronic disease patients taking long-term medication; and SF = 20 can be used for special sensitive populations, such as pregnant women and children, to increase the safety margin.

[0076] It should be noted that the selection of health reference values ​​should prioritize the relevance of target organs to the TCM's application. For example, if a specific TCM is primarily used to treat liver disease, the health reference value for heavy metals should prioritize liver toxicity endpoints. For TCMs used to treat kidney disease, particular attention should be paid to nephrotoxic heavy metals such as cadmium. This "targeted risk assessment" makes the results more accurate and practical. At the same time, it is important to note that health reference values ​​are updated as scientific research progresses. The assessment system should regularly update the health reference value database to ensure that the assessment is based on the latest scientific evidence.

[0077] In an optional embodiment, the toxic equivalent (TEQ) method can be used to assess the combined risk of heavy metals with similar toxicological mechanisms. Taking lead as the reference substance, the toxic equivalent factor (TEF) of each heavy metal is set according to the relative intensity of toxicity. For example, the TEF of arsenic may be 2.0, cadmium is 3.0, and mercury is 5.0. The exposure to each heavy metal is converted into lead equivalents through TEF, the total toxic equivalent exposure is calculated, and then compared with the health reference value of lead to obtain a comprehensive risk index. This method is suitable for assessing the combined risk of simultaneous exposure to multiple heavy metals, overcoming the limitations of traditional single risk index assessment.

[0078] In another alternative embodiment, a marginal exposure ratio (MOE) risk assessment framework can be established, where MOE is defined as the ratio of the lower limit of the benchmark dose to the actual exposure:

[0079] The larger the MOE, the higher the safety margin and the lower the risk. Generally speaking, for BMDLs derived from human studies, an MOE greater than 1 is considered low risk; for BMDLs derived from animal studies, an MOE greater than 100 is considered low risk, taking into account interspecies and individual differences. This approach avoids the subjectivity of selecting a safety factor and is widely used in risk assessments by organizations such as EFSA.

[0080] In the embodiment of the present application, step S500 performs weighted calculation based on the risk index of a single heavy metal and the characteristic parameters of the Chinese medicinal materials to obtain a comprehensive risk score, including the following steps E1-E2: E1: The calculation method of the risk index of a single heavy metal includes: When heavy metals have health guidance values, the risk index is equal to the ratio of human exposure to the health guidance value multiplied by the safety factor; When heavy metals do not have health guidance values, the risk index is equal to the inverse of the ratio of the lower limit of the benchmark dose to the human exposure multiplied by the safety factor.

[0081] E2: Chinese herbal medicine characteristic parameters include: The frequency of clinical use of Chinese medicinal materials; the average prescription dose of Chinese medicinal materials; the decoction and extraction methods of Chinese medicinal materials; the range of people who use Chinese medicinal materials; and the medicinal parts of Chinese medicinal materials.

[0082] E1: Collect and quantify the characteristic parameters of Chinese medicinal materials, including clinical usage frequency, average prescription dose, decoction and extraction method, user population range, and medicinal parts. The clinical usage frequency was divided into high frequency (100 times / year), medium frequency (30-100 times / year) and low frequency (<30 times / year) according to the average annual number of prescriptions, and assigned values ​​of 1.2, 1.0 and 0.8, respectively. The average prescription dose was calculated as the ratio to the conventional dose (10 g / day), with a high dose (15 g), a standard dose (5-15 g) and a low dose (<5 g) assigned a value of 1.2, 1.0 and 0.8 respectively. The decoction and extraction methods were divided into water decoction (assigned a value of 1.0), wine-braised (assigned a value of 1.1), vinegar-braised (assigned a value of 1.2) and others (such as honey-braised, assigned a value of 0.9). The user population was divided into broad-spectrum (assigned a value of 1.2), general (assigned a value of 1.0) and specific (assigned a value of 0.8). The medicinal parts were divided into roots (assigned a value of 1.2), fruits and seeds (assigned a value of 0.8) and other parts (assigned a value of 1.0) according to the degree of heavy metal enrichment.

[0083] E2: Based on these parameters, the TCM characteristic adjustment coefficient K is calculated to adjust the comprehensive risk score:

[0084] in, to These are the values ​​assigned to the five characteristic parameters mentioned above. K>1 indicates that risk-increasing factors dominate, and K<1 indicates that risk-reducing factors dominate. The comprehensive risk score is calculated as follows:

[0085] in, to is the weight coefficient of each heavy metal, to The weighting factor reflects the relative toxicity and level of concern for each heavy metal and can be determined based on expert surveys or toxicology data, such as 0.25 for lead, 0.25 for arsenic, 0.25 for mercury, 0.15 for cadmium, and 0.1 for copper. The adjustment factor K incorporates the characteristics of traditional Chinese medicines into risk assessments, making the results more consistent with clinical practice.

[0086] Specifically, in E1, the quantification of TCM characteristic parameters should be based on TCM literature research and clinical statistics. Clinical usage frequency can be determined by extracting prescription data from hospital information systems (HIS) or by referencing the frequency recommendations in the Chinese Pharmacopoeia and the Guidelines for the Clinical Application of Traditional Chinese Medicine. For example, commonly used antipyretics such as mulberry leaves and chrysanthemums are frequently used, while highly toxic herbs such as Strychnos nux vomica are less frequently used. Average prescription dosage data can be derived from hospital prescription statistics or records in TCM classics. It should be noted that the commonly used dosages of certain herbs, such as Coptis chinensis, have changed in recent years, and the latest clinical data should be used. The assignment of values ​​for decoction extraction methods primarily considers the impact of different processing methods on heavy metal release: studies have shown that acidic conditions (such as vinegar preparation) increase the release rate of certain heavy metals, such as lead and cadmium, by 20%–30%, while alkaline conditions (such as limewater preparation) may reduce the release rate of mercury by 15%–25%. The scope of use takes into account differences in human sensitivity: Broad-spectrum Chinese medicines like Codonopsis pilosula and Astragalus membranaceus can be used by a variety of populations, including those with sensitive conditions such as pregnant women, the elderly, and children; whereas specific Chinese medicines like Musk and Bezoar are typically used for specific conditions and have clear contraindications. The assignment of medicinal parts is based on botanical research on the distribution of heavy metals in different parts of plants: roots are typically in direct contact with the soil and have high levels of heavy metals; whereas organs further from the roots, such as fruits and seeds, have relatively low levels of heavy metals and can block some heavy metals from entering through selective absorption and transport in the xylem and phloem.

[0087] In E2, the calculation of the TCM characteristic adjustment coefficient K is based on a product rather than a weighted average. This is because there may be mutual influences between the various characteristic factors. For example, the risk level of TCMs with high frequency of use and large dosage will be significantly higher than the influence of any single factor; while the risk level of TCMs with low frequency of use and small dosage will be significantly lower. This multiplicative relationship can better capture the combined effects of multiple factors. The typical range of K is between 0.6 and 1.5, and in extreme cases it can reach 0.4 or 1.8. During the calculation process, the final comprehensive risk score will be standardized using a calibration factor to keep it within a reasonable range of 0-5, facilitating the subsequent risk level classification.

[0088] It should be noted that the inclusion of characteristic parameters of traditional Chinese medicines is one of the innovative features of this assessment method, complementing the traditional risk assessment approach that focuses solely on heavy metal content and transfer rates. These parameters were selected based on two principles: first, they must have a significant impact on actual risk; second, they must be quantifiable and data acquisition must be relatively easy. In practice, the selection of these parameters can be appropriately adjusted based on the specific assessment objectives and data availability. It is also important to note that these parameters are not static and should be updated and optimized as research progresses and clinical practice evolves.

[0089] In an optional implementation, a fuzzy comprehensive evaluation method can be used to address the uncertainty of TCM characteristic parameters. Each characteristic parameter is treated as a fuzzy set. Based on expert evaluation and literature data, a membership function is established to describe the ambiguity of parameter values. For example, the frequency of clinical use may have both "high frequency" and "medium frequency" characteristics, but with different membership degrees. Calculating a comprehensive risk score using fuzzy operators can better address practical issues such as fuzzy indicator boundaries and differences in expert judgment, bringing the evaluation results closer to clinical understanding.

[0090] In another alternative implementation, a model for the impact of TCM characteristics can be established based on network analysis. A network diagram of the relationships between parameters is constructed, and key influencing factors are identified through centrality analysis. For example, the dosage of certain TCM herbs is significantly correlated with the population range, with sensitive populations typically requiring a lower dosage. This network model can capture the complex interactions between parameters, avoiding the assessment bias associated with simple linear superposition, making it suitable for risk assessment of complex systems.

[0091] In the embodiment of the present application, step S600 classifies the health risks of heavy metals in traditional Chinese medicines based on the comprehensive risk score and generates an assessment report, including the following steps F1-F4: F1: The calculation of the comprehensive risk score includes: Assign a weight coefficient to each heavy metal risk index; sum up the weighted heavy metal risk indices; The total risk is adjusted according to the characteristic parameters of Chinese medicinal materials to obtain the final comprehensive risk score.

[0092] F2: The risk level classification module classifies risk levels according to the comprehensive risk score: Low risk: comprehensive risk score is less than or equal to 0.5; medium-low risk: comprehensive risk score is greater than 0.5 and less than or equal to 0.8; Medium risk: comprehensive risk score greater than 0.8 and less than or equal to 1.2; Medium-high risk: comprehensive risk score greater than 1.2 and less than or equal to 2.0; High risk: The overall risk score is greater than 2.0.

[0093] In F2, medium-low risk: the comprehensive risk score is ≤0.5, indicating that under normal use conditions, the heavy metal risk of the Chinese herbal medicine is extremely low and the long-term use safety is high; Medium-low risk: 0.5 < comprehensive risk score ≤ 0.8, indicating a low risk, but caution is required for long-term high-dose use; Medium risk: 0.8 < comprehensive risk score ≤ 1.2, indicating a certain risk, requiring attention to the user population, dosage, and course of treatment; Medium-high risk: 1.2 < comprehensive risk score ≤ 2.0, indicating a high risk. It is recommended to limit the frequency and dosage of use and not to use it long-term; High risk: The overall risk score is >2.0, indicating that the risk is significant. It is recommended to use alternatives or take special treatment measures to reduce the risk.

[0094] Low risk: Routine quality control is sufficient, no special restrictions; Medium to low risk: Pregnant women, children and other sensitive groups are advised to use with caution, and the annual random inspection pass rate should be monitored; Medium risk: It is recommended to control the dosage and treatment course, increase the frequency of random inspections, and study the processing technology to reduce heavy metals; Medium-to-high risk: It is recommended to strictly control the dosage, not to use it continuously for more than 2 weeks, and to conduct origin investigation and source optimization; High risk: It is recommended to suspend use, find alternatives or develop processing technology that can effectively reduce heavy metal content.

[0095] F3: Evaluation report generation includes: Basic information of Chinese herbal medicine samples; heavy metal content and comparison with limit standards; human exposure and risk index of each heavy metal; Comprehensive risk score and risk level; risk management recommendations and safe usage tips.

[0096] Basic information in F3: name of Chinese herbal medicine, origin, batch number, test date, etc.; heavy metal content data: test values ​​of each heavy metal and their comparison with the limit standards; Exposure assessment: the calculation process and results of human exposure to each heavy metal; Risk characteristics: the risk index and comprehensive risk score of each heavy metal; Risk Level: The risk level determined based on the score and its explanation; Usage Recommendations: Specific usage recommendations and precautions for this risk level; Appendix: Description of the evaluation method, parameter sources and reference list.

[0097] F4: It also includes the construction of a heavy metal risk database for Chinese medicinal materials. The database stores historical assessment results and risk trend analysis, which will be used as a reference for future risk warnings and the formulation of quality control standards for Chinese medicinal materials.

[0098] A heavy metal risk database for traditional Chinese medicines (TCMs) has been established to store historical assessment results and risk trend analysis data. The database is categorized by TCM type, origin, and part of the body used, facilitating search and comparison. Data mining techniques are used to analyze risk differences among TCMs based on origin, harvest season, and production location, identifying high-risk herbs and production areas, and providing a basis for decision-making in industry optimization and regulation. Furthermore, iterative updates to risk assessment methods are tracked to ensure the comparability and continuity of assessment results.

[0099] Specifically, in F1, the risk classification standards were developed based on extensive historical data analysis and expert consensus. A statistical analysis of the heavy metal risk assessment results for 1,000 commonly used Chinese medicinal materials revealed a right-skewed distribution of risk scores. Approximately 60% of Chinese medicinal materials scored below 0.8, falling into the low-risk and medium-low risk ranges; approximately 30% scored between 0.8 and 1.2, falling into the medium-risk range; approximately 8% scored between 1.2 and 2.0, falling into the medium-high risk range; and approximately 2% scored over 2.0, falling into the high-risk range. This distribution is consistent with the overall understanding of medicinal safety and provides a statistical basis for the classification of different levels. The risk classification not only considers the numerical score but also incorporates adverse reaction data observed in clinical use, ensuring a good correlation between the risk level and actual health risks.

[0100] In F2, risk management recommendations are formulated based on the principle of "tiered control and differentiated policy implementation," proposing specific and feasible measures tailored to different risk levels and the characteristics of the TCM. For medium-risk TCMs, in addition to controlling dosage and duration of treatment, specific processing methods can be recommended to mitigate risk. For example, research has shown that specific processing methods, such as repeated water-blending and charcoal-roasting, can significantly reduce the transfer rate of heavy metals by 20% to 50%. For medium- and high-risk TCMs, in addition to controlling the herbs themselves, compatibility strategies should be considered. For example, combining herbs with detoxifying properties, such as licorice and mung beans, can mitigate heavy metal toxicity. For high-risk TCMs, resource substitution research can be conducted to identify alternatives with lower heavy metal content from plants of the same genus or closely related species, or to develop cultivated varieties with consistent chemical composition but significantly reduced heavy metal content.

[0101] In F3, assessment reports are generated using a modular design, providing varying levels of detail depending on the intended user. Reports for regulatory authorities must provide complete data and methodological descriptions; reports for medicinal material manufacturers emphasize risk management recommendations and process improvement directions; reports for clinicians focus on medication recommendations and precautions for special populations; and reports for the public utilize concise, easy-to-understand language and visual charts to avoid unnecessary panic. Natural language generation (NLG) technology is used in report generation to convert numerical results into readable descriptive text, complemented by risk radar charts and heat maps to visually demonstrate the composition and distribution of risks.

[0102] In F4, the heavy metal risk database for traditional Chinese medicines (TCMs) utilizes a distributed architecture, supporting multi-source data access and multi-dimensional queries. The database not only stores assessment results but also collects relevant research literature, policies and regulations, and market trends to form a knowledge graph. Time series analysis tracks risk trends for specific TCMs. Using a geographic information system (GIS), risk maps of TCM origins are created to identify high-risk areas. Association rule mining uncovers correlations between heavy metal content and other variables, such as environmental factors, planting methods, and harvesting times, providing a scientific basis for risk warning and prevention.

[0103] It should be noted that risk assessment reports should not simply output data and conclusions; rather, they should serve as tools to facilitate scientific decision-making and risk communication. Effective reports can accurately convey risk information, promote a correct understanding of risks among all stakeholders, and promote the implementation of appropriate risk management measures. Furthermore, the development of a risk database is a key step in shifting the safety management of traditional Chinese medicines from reactive response to proactive prevention. Through data accumulation and analysis, early risk identification and prevention can be achieved.

[0104] In an alternative implementation, a blockchain-based risk assessment and traceability system for traditional Chinese medicines (TCMs) could be established. Data from the entire TCM process, from planting and harvesting to testing and risk assessment, would be stored on-chain, ensuring the data's authenticity, reliability, and immutability. Assessment reports would be automatically generated and uploaded to the blockchain via smart contracts. Authorized stakeholders could access the complete assessment record, enhancing system transparency and strengthening consumer confidence. This system is particularly suitable for the refined management of high-risk TCMs, enabling comprehensive risk management from the field to the hospital.

[0105] In another optional implementation, a mobile application (APP) can be developed to enable instant query and push of risk information. Physicians, pharmacists, and patients can scan the QR code on the packaging of Chinese medicinal materials or Chinese herbal medicine slices to instantly obtain the heavy metal risk assessment results and usage recommendations for that batch of products. The system can provide personalized medication recommendations based on the user's identity (such as ordinary adults, pregnant women, children, the elderly, etc.) and health status, achieve accurate communication and hierarchical display of risk information, and effectively reduce risk perception bias and irrational medication caused by information asymmetry.

[0106] In summary, the method for risk assessment of heavy metals in traditional Chinese medicines provided by the present invention establishes a comprehensive risk assessment model, takes into account basic factors such as heavy metal content, transfer rate, and human exposure, and introduces characteristic parameters of traditional Chinese medicines for weighted adjustment, thereby achieving a scientific, comprehensive, and accurate risk assessment. This method not only outputs quantitative risk scores and grading, but also provides targeted risk management and control recommendations and standardized assessment reports, and provides continuous support for the safety management of traditional Chinese medicines by establishing a dynamically updated risk database. Compared with traditional assessment methods, the present invention better adapts to the characteristics of the use of traditional Chinese medicines, and the assessment results have more clinical guidance value, providing important technical support for ensuring the safety of traditional Chinese medicines and promoting the healthy development of the traditional Chinese medicine industry.

[0107] Example 3 The above is a schematic diagram of a method for heavy metal risk assessment in traditional Chinese medicines. It should be noted that the technical solution of the system for heavy metal risk assessment in traditional Chinese medicines and the technical solution of the method for heavy metal risk assessment in traditional Chinese medicines are based on the same concept. For details not described in detail in the technical solution of the system for heavy metal risk assessment in traditional Chinese medicines in this embodiment, please refer to the description of the technical solution of the method for heavy metal risk assessment in traditional Chinese medicines.

[0108] This embodiment also provides a system for heavy metal risk assessment in traditional Chinese medicines, comprising: Data acquisition module. Obtains heavy metal content data of Chinese herbal medicine samples and preprocesses the heavy metal content data to obtain standardized heavy metal content data; Construct modules and establish a heavy metal risk assessment model, which includes a risk level classification module and a comprehensive risk scoring module; The calculation module calculates the human exposure to heavy metals based on the frequency of use of Chinese medicinal materials, years of exposure, daily dosage, transfer rate and heavy metal content data; The comparison module compares human exposure with the preset heavy metal health reference value to obtain the risk index of a single heavy metal; The weighting module performs weighted calculations based on the risk index of a single heavy metal and the characteristic parameters of Chinese medicinal materials to obtain a comprehensive risk score; The result output module classifies the health risks of heavy metals in Chinese medicinal materials and generates an assessment report based on the comprehensive risk score.

[0109] This embodiment also provides an electronic device suitable for heavy metal risk assessment in traditional Chinese medicines, comprising: a memory and a processor; the memory is used to store computer-executable instructions, and the processor is used to execute computer-executable instructions to implement the method for heavy metal risk assessment in traditional Chinese medicines proposed in the above embodiment.

[0110] This embodiment further provides a storage medium storing a computer program, which, when executed by a processor, implements the method for implementing the risk assessment of heavy metals in traditional Chinese medicines proposed in the above embodiment.

[0111] The storage medium proposed in this embodiment and the method for realizing heavy metal risk assessment in traditional Chinese medicine proposed in the above embodiment belong to the same inventive concept. For technical details not described in detail in this embodiment, please refer to the above embodiment, and this embodiment has the same beneficial effects as the above embodiment.

[0112] From the above description of the embodiments, those skilled in the art will clearly understand that the present invention can be implemented using software and necessary general-purpose hardware, and of course, can also be implemented using hardware. Based on this understanding, the technical solution of the present invention, or the portion that contributes to the prior art, can be embodied in the form of a software product. This software product can be stored on a computer-readable storage medium, such as a computer floppy disk, read-only memory (ROM), random access memory (RAM), flash memory (FLASH), hard disk, or optical disk, and includes instructions for causing a computer device (which can be a personal computer, server, or network device, etc.) to execute the methods of various embodiments of the present invention.

[0113] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that the technical solutions of the present invention may be modified or replaced by equivalents without departing from the spirit and scope of the technical solutions of the present invention, which should all be included in the scope of the claims of the present invention.

Claims

1. A method for heavy metal risk assessment in traditional Chinese medicine, characterized by: The method comprises obtaining heavy metal content data of a Chinese herbal medicine sample and preprocessing the heavy metal content data to obtain standardized heavy metal content data; Establishing a heavy metal risk assessment model, wherein the heavy metal risk assessment model includes a risk level classification module and a comprehensive risk scoring module; Calculate the human exposure to heavy metals based on the frequency of use of Chinese medicinal materials, years of exposure, daily dosage, transfer rate, and heavy metal content data; Comparing the human exposure amount with the preset heavy metal health reference value to obtain a risk index for a single heavy metal; A comprehensive risk score is obtained by performing a weighted calculation based on the risk index of the single heavy metal and the characteristic parameters of the Chinese medicinal materials; Based on the comprehensive risk score, the health risks of heavy metals in the Chinese medicinal materials are graded and an assessment report is generated.

2. The method for heavy metal risk assessment in traditional Chinese medicine according to claim 1, wherein: The heavy metal content data includes content data of lead, arsenic, mercury, cadmium and copper.

3. The method for heavy metal risk assessment in traditional Chinese medicine according to claim 2, wherein: The human exposure calculations take into account the following factors: Frequency of use refers to the number of days per year that the Chinese herbal medicine is taken; years of exposure refers to the cumulative number of years of long-term use of the Chinese herbal medicine; The daily dosage is the number of grams of the Chinese herbal medicine taken per day; the transfer rate is the percentage of heavy metals in the Chinese herbal medicine transferred to the decoction through decoction or other treatment methods; Average human weight and average life expectancy.

4. The method for heavy metal risk assessment in traditional Chinese medicine according to claim 3, wherein: The preset heavy metal health reference values ​​include: For heavy metals with health-related guidance values, use their officially published health-related guidance values; For heavy metals that do not have official health guidance values, their lower benchmark dose limits shall be used.

5. The method for heavy metal risk assessment in traditional Chinese medicine according to claim 4, characterized in that: The calculation method of the risk index of a single heavy metal includes: When heavy metals have health guidance values, the risk index is equal to the ratio of human exposure to the health guidance value multiplied by the safety factor; When heavy metals do not have health guidance values, the risk index is equal to the inverse of the ratio of the lower limit of the benchmark dose to the human exposure multiplied by the safety factor.

6. The method for heavy metal risk assessment in traditional Chinese medicine according to claim 5, characterized in that: The characteristic parameters of the Chinese medicinal materials include: The frequency of clinical use of Chinese medicinal materials; the average prescription dose of Chinese medicinal materials; the decoction and extraction methods of Chinese medicinal materials; the range of people who use Chinese medicinal materials; and the medicinal parts of Chinese medicinal materials.

7. The method for heavy metal risk assessment in traditional Chinese medicine according to claim 6, characterized in that: The calculation of the comprehensive risk score includes: Assign a weight coefficient to each heavy metal risk index; sum up the weighted heavy metal risk indices; The total risk is adjusted according to the characteristic parameters of Chinese medicinal materials to obtain the final comprehensive risk score.

8. The method for heavy metal risk assessment in traditional Chinese medicines according to claim 7, wherein: The risk level classification module classifies risk levels according to the comprehensive risk score: Low risk: comprehensive risk score is less than or equal to 0.5; Medium-low risk: comprehensive risk score greater than 0.5 and less than or equal to 0.8; Medium risk: comprehensive risk score greater than 0.8 and less than or equal to 1.2; medium to high Risk: The overall risk score is greater than 1.2 and less than or equal to 2.0; High risk: The overall risk score is greater than 2.

0.

9. The method for heavy metal risk assessment in traditional Chinese medicines according to claim 8, wherein: The evaluation report generation includes: Basic information of Chinese herbal medicine samples; heavy metal content and comparison with limit standards; human exposure and risk index of each heavy metal; Comprehensive risk score and risk level; risk management recommendations and safe usage tips.

10. The method for heavy metal risk assessment in traditional Chinese medicine according to claim 9, characterized in that: It also includes building a heavy metal risk database for traditional Chinese medicines, which stores historical assessment results and risk trend analysis for reference in future risk warnings and the formulation of quality control standards for traditional Chinese medicines.

Images