A method and system for heavy metal probabilistic risk assessment of rhizome Chinese medicinal material Curcuma zedoaria

Abstract

The present invention relates to a method and system for evaluating the probability risk of heavy metals in a rhizome Chinese medicine Curcuma zedoaria. The method comprises: establishing a chronic exposure evaluation model; using an empirical distribution fitting method to obtain the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated and the intake and frequency of the heavy metal to be evaluated, and using the chronic exposure evaluation model to calculate the daily exposure of the heavy metal to be evaluated in the Chinese medicine to be evaluated, thereby calculating the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metal to be evaluated in the Chinese medicine to be evaluated, and performing risk evaluation accordingly. The method of the present invention proposes an exposure estimation method for multiple heavy metals in rhizome Chinese medicines and a non-carcinogenic and carcinogenic probability risk evaluation method, and achieves the purpose of quantifying the uncertainty existing in the evaluation process through random simulation sampling, thereby improving the accuracy of risk evaluation.

Description

Technical Field

[0001] The invention relates to the technical field of risk assessment of traditional Chinese medicines, and in particular to a method and system for heavy metal probability risk assessment of rhizome traditional Chinese medicine Curcuma zedoaria. Background Art

[0002] China is rich in Chinese herbal medicine resources. Due to its unique efficacy and few side effects, Chinese medicine is now widely used in China and many other countries to treat a variety of diseases and has received increasing attention. Among them, rhizome Chinese herbal medicines are herbal medicines with underground stems or underground stems with a few roots, including Polygonatum odoratum, Curcuma zedoaria, Morinda officinalis and Linderae sibiricum. Curcuma zedoaria has been widely used in Chinese medicine prescriptions because of its pharmacological effects such as promoting blood circulation and removing blood stasis, antibacterial, anti-inflammatory and anti-tumor. However, people attach great importance to its safety. With the deepening of research, it is found that heavy metal pollution is one of the main causes of health hazards caused by Chinese medicine. Air and soil pollution, as well as the preparation and transportation of Chinese medicine will aggravate the pollution of heavy metals in Chinese medicine.

[0003] When people take rhizomes of Chinese medicine contaminated with heavy metals for a long time, it may cause metal accumulation in the human body and cause a series of health hazards. Heavy metal pollution in common Chinese medicines mainly includes lead, cadmium, arsenic, mercury and copper. Long-term accumulation of lead in the human body can damage the nervous and hematopoietic systems of the human body, resulting in adverse health outcomes such as neuritis and anemia. In addition to causing bone damage, long-term accumulation of cadmium in the body will also cause a certain degree of harm to the kidneys, cardiovascular and other systems. The toxicity of different arsenic is related to its arsenic form. Among them, inorganic arsenic is the most toxic and mainly acts on the nervous, digestive and hematopoietic systems. Due to the different heavy metal background values ​​in different regions and the different absorption and enrichment capabilities of various parts of Chinese herbal medicines for heavy metals, the heavy metal content of different batches of Chinese medicines across the country is also different.

[0004] In recent years, the risk research of heavy metal pollutants in food, drinking water, etc. has made great progress, and its assessment methods mainly include point assessment and probability assessment. The point assessment method used in heavy metals in traditional Chinese medicine is to multiply the content of heavy metals in Chinese herbal medicines by the intake of Chinese herbal medicines to obtain the intake of heavy metals, and then compare it with the reference dose of heavy metals to conduct risk assessment. In the assessment of heavy metal exposure in traditional Chinese medicine, due to the differences in the use of traditional Chinese medicine among the population, the persistence of the range of use of traditional Chinese medicines, the promiscuity of drug formulas, and the diversity of forms and dosage forms, the results of point assessment cannot take into account the variability problems in health risks. The results are relatively rough and the assessment accuracy is low. Its assessment results cannot protect the high-end exposed population. Summary of the invention

[0005] The purpose of the present invention is to provide a method and system for heavy metal probability risk assessment of rhizome Chinese medicine Curcuma zedoaria, so as to improve the accuracy of risk assessment.

[0006] To achieve the above object, the present invention provides the following solutions:

[0007] A probabilistic risk assessment method for heavy metals in rhizome Chinese medicinal material Curcuma zedoaria, comprising:

[0008] Establishment of chronic exposure assessment model;

[0009] The empirical distribution fitting method is used to obtain the concentration of the heavy metals to be evaluated in the Chinese medicine to be evaluated, as well as the intake and frequency of the Chinese medicine to be evaluated; the Chinese medicine to be evaluated includes the rhizome Chinese medicine Curcuma; the heavy metals to be evaluated include lead, cadmium, arsenic, mercury and copper; the intake of the Chinese medicine to be evaluated is the daily consumption of the Chinese medicine to be evaluated; the intake frequency of the Chinese medicine to be evaluated is the annual consumption days of the Chinese medicine to be evaluated;

[0010] According to the concentration of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated and the intake amount and intake frequency of the traditional Chinese medicine to be evaluated, the chronic exposure assessment model is used to calculate the daily exposure amount of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated;

[0011] Calculating the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated according to the daily exposure amount of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated;

[0012] Risk assessment is performed based on the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated.

[0013] Optionally, the establishment of a chronic exposure assessment model specifically includes:

[0014] The chronic exposure assessment model was established based on the usage characteristics of traditional Chinese medicine among the Chinese population Wherein, CDI is the daily exposure amount of the heavy metal to be evaluated in the Chinese medicine to be evaluated, P is the annual consumption days of the Chinese medicine to be evaluated, Ed is the lifetime exposure period of the Chinese medicine to be evaluated, M is the daily consumption of the Chinese medicine to be evaluated, C is the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated, t is the conversion rate of the heavy metal to be evaluated from the Chinese medicine to the soup, AT is the average life expectancy of the population, and W is the body weight.

[0015] Optionally, the calculating of the chronic exposure non-carcinogenic risk entropy and the combined non-carcinogenic risk entropy of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated according to the daily exposure amount of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated specifically includes:

[0016] According to the daily exposure CDI of the heavy metals to be evaluated in the Chinese medicine to be evaluated, the formula Calculate the chronic exposure non-carcinogenic risk entropy HQ of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated; wherein HBGV is the health guidance value of the heavy metal to be evaluated;

[0017] According to the chronic exposure non-carcinogenic risk entropy HQ of the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, the formula HI=HQPb+HQCd+HQAs+HQHg+HQCu is used to calculate the joint non-carcinogenic risk entropy HI generated by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated; wherein HQPb, HQCd, HQAs, HQHg and HQCu are the chronic exposure non-carcinogenic risk entropies of the heavy metals lead, cadmium, arsenic, mercury and copper to be evaluated in the traditional Chinese medicine to be evaluated, respectively.

[0018] Optionally, the calculating of the chronic carcinogenic risk entropy and the combined carcinogenic risk entropy of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated according to the daily exposure amount of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated specifically includes:

[0019] According to the daily exposure amount CDI of the heavy metal to be evaluated in the Chinese medicine to be evaluated, the chronic carcinogenic risk entropy CR of the heavy metal to be evaluated in the Chinese medicine to be evaluated is calculated using the formula CR=CDI*SF; wherein SF is the slope coefficient;

[0020] According to the chronic carcinogenic risk entropy CR of the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, the formula TCR=CRPb+CRCd+CRAs is used to calculate the combined carcinogenic risk entropy TCR generated by the carcinogenic heavy metals in the traditional Chinese medicine to be evaluated; wherein CRPb, CRCd and CRAs are the chronic carcinogenic risk entropies of the carcinogenic heavy metals lead, cadmium and arsenic in the traditional Chinese medicine to be evaluated, respectively.

[0021] Optionally, the method further comprises:

[0022] A sensitivity analysis is performed based on the combined non-carcinogenic risk entropy HI generated by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, and key factors for reducing the health risks caused by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated are determined.

[0023] A heavy metal probabilistic risk assessment system for rhizome Chinese medicine Curcuma zedoaria, comprising:

[0024] Exposure assessment model building module, used to build chronic exposure assessment models;

[0025] An empirical distribution fitting module is used to obtain the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated and the intake and intake frequency of the Chinese medicine to be evaluated by using the empirical distribution fitting method; the Chinese medicine to be evaluated includes the rhizome Chinese medicine Curcuma; the heavy metals to be evaluated include lead, cadmium, arsenic, mercury and copper; the intake of the Chinese medicine to be evaluated is the daily consumption of the Chinese medicine to be evaluated; the intake frequency of the Chinese medicine to be evaluated is the annual consumption days of the Chinese medicine to be evaluated;

[0026] A heavy metal exposure calculation module, used to calculate the daily exposure of the heavy metal to be evaluated in the Chinese medicine to be evaluated using the chronic exposure assessment model according to the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated and the intake and frequency of the Chinese medicine to be evaluated;

[0027] A heavy metal non-carcinogenic and carcinogenic risk calculation module, used to calculate the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated according to the daily exposure amount of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated;

[0028] The heavy metal non-carcinogenic and carcinogenic risk assessment module is used to perform risk assessment based on the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metal to be assessed in the traditional Chinese medicine to be assessed.

[0029] Optionally, the exposure assessment model building module specifically includes:

[0030] An exposure assessment model building unit is used to build the chronic exposure assessment model according to the usage characteristics of Chinese medicine among the Chinese population Wherein, CDI is the daily exposure amount of the heavy metal to be evaluated in the Chinese medicine to be evaluated, P is the annual consumption days of the Chinese medicine to be evaluated, Ed is the lifetime exposure period of the Chinese medicine to be evaluated, M is the daily consumption of the Chinese medicine to be evaluated, C is the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated, t is the conversion rate of the heavy metal to be evaluated from the Chinese medicine to the soup, AT is the average life expectancy of the population, and W is the body weight.

[0031] Optionally, the heavy metal non-carcinogenic and carcinogenic risk calculation module specifically includes:

[0032] The chronic exposure non-carcinogenic risk entropy calculation unit is used to calculate the daily exposure amount CDI of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated, using the formula Calculate the chronic exposure non-carcinogenic risk entropy HQ of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated; wherein HBGV is the health guidance value of the heavy metal to be evaluated;

[0033] The combined non-carcinogenic risk entropy calculation unit is used to calculate the combined non-carcinogenic risk entropy HI generated by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated according to the chronic exposure non-carcinogenic risk entropy HQ of the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, using the formula HI=HQPb+HQCd+HQAs+HQHg+HQCu; wherein HQPb, HQCd, HQAs, HQHg and HQCu are the chronic exposure non-carcinogenic risk entropies of the heavy metals lead, cadmium, arsenic, mercury and copper to be evaluated in the traditional Chinese medicine to be evaluated, respectively.

[0034] Optionally, the heavy metal non-carcinogenic and carcinogenic risk calculation module further includes:

[0035] A chronic carcinogenic risk calculation unit, used to calculate the chronic carcinogenic risk entropy CR of the heavy metal to be evaluated in the Chinese medicine to be evaluated according to the daily exposure CDI of the heavy metal to be evaluated in the Chinese medicine to be evaluated, using the formula CR=CDI*SF; wherein SF is a slope coefficient;

[0036] The combined carcinogenic risk entropy calculation unit is used to calculate the combined carcinogenic risk entropy TCR generated by the carcinogenic heavy metals in the traditional Chinese medicine to be evaluated according to the chronic carcinogenic risk entropy CR of the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, using the formula TCR=CRPb+CRCd+CRAs; wherein CRPb, CRCd and CRAs are the chronic carcinogenic risk entropies of the carcinogenic heavy metals lead, cadmium and arsenic in the traditional Chinese medicine to be evaluated, respectively.

[0037] Optionally, the system further comprises:

[0038] The sensitivity analysis module is used to perform sensitivity analysis based on the combined non-carcinogenic risk entropy HI generated by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, and determine the key factors for reducing the health risks caused by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated.

[0039] According to the specific embodiments provided by the present invention, the present invention discloses the following technical effects:

[0040] The present invention provides a method and system for evaluating the probability risk of heavy metals in a rhizome Chinese medicine Curcuma zedoaria. The method comprises: establishing a chronic exposure assessment model; using an empirical distribution fitting method to obtain the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated and the intake amount and intake frequency of the Chinese medicine to be evaluated; the Chinese medicine to be evaluated comprises the rhizome Chinese medicine Curcuma zedoaria; the heavy metals to be evaluated comprise lead, cadmium, arsenic, mercury and copper; the intake amount of the Chinese medicine to be evaluated is the daily consumption of the Chinese medicine to be evaluated; the intake frequency of the Chinese medicine to be evaluated is the annual consumption days of the Chinese medicine to be evaluated; and the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated is obtained according to the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated. Estimate the concentration of heavy metals and the intake and frequency of the Chinese medicine to be evaluated, use the chronic exposure assessment model to calculate the daily exposure of the heavy metal to be evaluated in the Chinese medicine to be evaluated; calculate the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metal to be evaluated in the Chinese medicine to be evaluated according to the daily exposure of the heavy metal to be evaluated in the Chinese medicine to be evaluated; perform risk assessment according to the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metal to be evaluated in the Chinese medicine to be evaluated. The method of the present invention proposes a method for estimating the exposure of multiple heavy metals in rhizome Chinese medicines and a probabilistic risk assessment method for non-carcinogenicity and carcinogenicity, and achieves the purpose of quantifying the uncertainty existing in the evaluation process through random simulation sampling, thereby improving the accuracy of risk assessment. BRIEF DESCRIPTION OF THE DRAWINGS

[0041] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. 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 creative labor.

[0042] Figure 1 A flowchart of a method for evaluating the probability of heavy metals in a rhizome Chinese medicinal herb, Curcuma zedoaria, provided by the present invention;

[0043] Figure 2 A schematic diagram of a heavy metal probability risk assessment framework for the traditional Chinese medicine Curcuma zedoaria provided in an embodiment of the present invention;

[0044] Figure 3 A box plot of the heavy metal concentration lead in Curcuma zedoaria provided by an embodiment of the present invention;

[0045] Figure 4 A probability distribution diagram of heavy metal lead concentration in Curcuma zedoaria provided by an embodiment of the present invention;

[0046] Figure 5 A schematic diagram of the probability distribution (total population) of the non-carcinogenic risk entropy (HQ1) of heavy metal lead (Pb) in the traditional Chinese medicine Curcuma zedoaria provided in an embodiment of the present invention;

[0047] Figure 6 A schematic diagram of the probability distribution (male) of the non-carcinogenic risk entropy (HQ2) of heavy metal lead (Pb) in the traditional Chinese medicine Curcuma zedoaria provided in an embodiment of the present invention;

[0048] Figure 7 A schematic diagram of the probability distribution (for females) of the non-carcinogenic risk entropy (HQ3) of heavy metal lead (Pb) in the traditional Chinese medicine Curcuma zedoaria provided in an embodiment of the present invention;

[0049] Figure 8 The heavy metal combined non-carcinogenic risk entropy (HI) of the traditional Chinese medicine Curcuma zedoaria provided in the embodiment of the present invention total ) Probability distribution diagram;

[0050] Fig. 9 The heavy metal combined carcinogenic risk entropy (TCR) of the traditional Chinese medicine Curcuma zedoaria provided in the embodiment of the present invention total ) Probability distribution diagram;

[0051] Fig.10 A schematic diagram of the sensitivity analysis results of heavy metal HI of the traditional Chinese medicine Curcuma zedoaria provided in an embodiment of the present invention;

[0052] Fig.11 This is a structural diagram of a heavy metal probability risk assessment system for the rhizome Chinese medicinal herb Curcuma zedoaria provided by the present invention. DETAILED DESCRIPTION

[0053] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0054] The purpose of the present invention is to provide a method and system for heavy metal probability risk assessment of rhizome Chinese medicine Curcuma zedoaria, so as to improve the accuracy of risk assessment.

[0055] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0056] Figure 1 The present invention provides a flow chart of a method for evaluating the probability of heavy metals in the rhizome Chinese medicine Curcuma zedoaria. Figure 1 As shown, a method for heavy metal probability risk assessment of rhizome Chinese medicine Curcuma zedoaria of the present invention comprises:

[0057] Step 101: Develop a chronic exposure assessment model.

[0058] The daily consumption of Curcuma zedoaria M, the annual consumption days P, and the concentration of a certain heavy metal C are taken as an independent distribution population. After obtaining its distribution characteristics and parameters based on the existing data, random sampling is performed in the population using the statistical simulation method, and multiplied by the following formula with other fixed values ​​to obtain the exposure amount of a certain heavy metal in Curcuma zedoaria. After repeated random sampling of the above process, the exposure distribution of the population can be finally obtained, and its percentile is calculated on this basis to obtain the exposure values ​​of different levels of the population.

[0059] Testing the heavy metal content of the traditional Chinese medicine Curcuma zedoaria by sampling in multiple provinces and units in China can reflect the actual situation in the country, with a wide coverage and representativeness.

[0060] According to the frequency of taking the Chinese herbal medicine, the number of years of taking the Chinese herbal medicine, and the average daily consumption, the chronic exposure level CDI of each heavy metal in the Chinese herbal medicine Curcuma is calculated. The calculation formula of the chronic exposure is as follows:

[0061]

[0062] Among them, CDI is the daily exposure of an individual to a certain heavy metal, C is the concentration of a certain metal in a certain traditional Chinese medicine, M is the daily consumption of the traditional Chinese medicine, P is the annual consumption days of the traditional Chinese medicine, Ed is the lifetime exposure to the traditional Chinese medicine; t is the conversion rate of the metal released from the traditional Chinese medicine into the soup; AT is the average life span in days; W is the human body weight (unit: Kg).

[0063] Therefore, the step 101 of establishing a chronic exposure assessment model specifically includes:

[0064] The chronic exposure assessment model was established based on the usage characteristics of traditional Chinese medicine among the Chinese population Wherein, CDI is the daily exposure amount of the heavy metal to be evaluated in the Chinese medicine to be evaluated, P is the annual consumption days of the Chinese medicine to be evaluated, Ed is the lifetime exposure period of the Chinese medicine to be evaluated, M is the daily consumption of the Chinese medicine to be evaluated, C is the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated, t is the conversion rate of the heavy metal to be evaluated from the Chinese medicine to the soup, AT is the average life expectancy of the population, and W is the body weight.

[0065] Step 102: using an empirical distribution fitting method to obtain the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated and the intake amount and intake frequency of the Chinese medicine to be evaluated.

[0066] The Chinese medicine to be evaluated includes the root and stem Chinese medicine Curcuma zedoaria. The heavy metals to be evaluated include lead, cadmium, arsenic, mercury and copper. The intake of the Chinese medicine to be evaluated is the daily consumption of the Chinese medicine to be evaluated; the intake frequency of the Chinese medicine to be evaluated is the annual consumption days of the Chinese medicine to be evaluated.

[0067] The empirical distribution fitting method for concentration C, TCM intake M and intake frequency P is introduced below.

[0068] Type C of metal concentration in Curcuma and fitting ideas: According to the data obtained from the survey, the data of metal concentration in Curcuma is 32 batches. Combined with the existing surveys and studies, the heavy metal concentration of Chinese traditional medicine is a continuous variable, and there are more data in the distribution of medium and low concentrations, and there are a small number of high concentration values, which belong to the skewed distribution in the statistical distribution. That is, firstly, a simple statistical description of the data is made, and the larger or smaller outliers are found through the box plot, and the mean value after removing the outliers is used to replace the outliers to improve the data fitting effect. Then, the existing data of a certain metal is used to perform the goodness of fit test of 4 skewed distributions (Weibull distribution, Gamma distribution, lognormal distribution, exponential distribution). Combining the test results with QQ graphs, PP graphs and other graphics can more intuitively see whether the data conforms to a certain distribution, and select the best distribution of metal concentration. If the metal conforms to a certain distribution, random numbers are generated from the distribution in CDI and other calculations. If the metal data does not conform to these 4 distributions, the original data is calculated by sampling process with replacement in CDI calculation.

[0069] The idea of ​​fitting the empirical distribution of the daily consumption M of the Chinese medicine Curcuma: Considering that Chinese medicine decoction is generally a mixture of several medicines, the dosage of a certain component of the Chinese medicine cannot be accurately estimated by the general population. Therefore, the reference dosage range of the dosage of Curcuma in the Pharmacopoeia is used for reference to make a simulation estimate. For example, the dosage of Curcuma in the Pharmacopoeia is stipulated as 6-9g, and only the upper and lower limits of the dosage are obtained. Assuming that the dosage of Curcuma in a prescription is 6-9g with uniform probability, then the uniform distribution is adopted.

[0070] The idea of ​​fitting the empirical distribution of the annual consumption days P of the Chinese medicine Curcuma: In the risk assessment of Chinese medicine, due to individual differences in the consumption of Chinese medicine, there is a lot of variability between populations. In order to accurately conduct the risk assessment of Chinese medicine metals, it is hoped that the distribution of individual Chinese medicine consumption days data can be fitted, and then individual random sampling can be performed to quantify the variability between individuals. For the target question "How many days in 180 days does an individual take Chinese medicine", assuming that the probability of individuals taking Chinese medicine every day in the group is π, then combined with statistical knowledge, the number of days P of individuals taking Chinese medicine obeys the binomial distribution with parameters π and 180, P~B(π,180). However, since the probability π of an individual taking Chinese medicine every day is unknown, and the probability of taking Chinese medicine is different from individual to individual, it can be further assumed that the probability π obeys the beta distribution, π~Beta(α,β), then the number of days P of intake conforms to the constructed beta binomial distribution, and the parameters α and β can be estimated through the individual Chinese medicine consumption data of the surveyed population.

[0071] Step 103: Calculate the daily exposure of the heavy metal in the Chinese medicine using the chronic exposure assessment model according to the concentration of the heavy metal in the Chinese medicine and the intake and frequency of the Chinese medicine.

[0072] Step 104: Calculate the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated according to the daily exposure amount of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated.

[0073] The non-carcinogenic risk calculation formula for chronic exposure to heavy metals in Curcuma is as follows:

[0074]

[0075] HI=HQPb+HQCd+HQAs+HQHg+HQCu (3)

[0076] Where HQ is the risk entropy. When HQ>1, the risk of population exposure cannot be ignored. In the present invention, it is considered that the metal intake through traditional Chinese medicine does not exceed 10% of HBGV, which is within the safe range. At the same time, the cumulative non-carcinogenic health effect HI produced by a traditional Chinese medicine is the sum of various health effects.

[0077] Optionally, the formula for calculating the chronic carcinogenic risk of heavy metals in Curcuma zedoaria is as follows:

[0078] CR=CDI*SF (4)

[0079] TCR=CRPb+CRCd+CRAs (5)

[0080] The calculation formula of the lifetime carcinogenic risk CR of heavy metals is shown above. The cumulative carcinogenic effect TCR of three carcinogenic metals is the sum of the individual carcinogenic effects. Generally, CR>10 -6 As a limit, the carcinogenic health effects beyond its value cannot be ignored.

[0081] Therefore, the step 104 calculates the chronic exposure non-carcinogenic risk entropy and the combined non-carcinogenic risk entropy of the heavy metal to be evaluated in the Chinese medicine to be evaluated according to the daily exposure amount of the heavy metal to be evaluated in the Chinese medicine to be evaluated, and specifically includes:

[0082] According to the daily exposure CDI of the heavy metals to be evaluated in the Chinese medicine to be evaluated, the formula Calculate the chronic exposure non-carcinogenic risk entropy HQ of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated; wherein HBGV is the health guidance value of the heavy metal to be evaluated;

[0083] According to the chronic exposure non-carcinogenic risk entropy HQ of the heavy metals to be evaluated in the Chinese medicine to be evaluated, the formula HI=HQPb+HQCd+HQAs+HQHg+HQCu is used to calculate the joint non-carcinogenic risk entropy HI generated by the heavy metals to be evaluated in the Chinese medicine to be evaluated; wherein HQPb, HQCd, HQAs, HQHg and HQCu are the chronic exposure non-carcinogenic risk entropies of the heavy metals lead, cadmium, arsenic, mercury and copper to be evaluated in the Chinese medicine to be evaluated, respectively;

[0084] According to the daily exposure amount CDI of the heavy metal to be evaluated in the Chinese medicine to be evaluated, the chronic carcinogenic risk entropy CR of the heavy metal to be evaluated in the Chinese medicine to be evaluated is calculated using the formula CR=CDI*SF; wherein SF is the slope coefficient;

[0085] According to the chronic carcinogenic risk entropy CR of the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, the formula TCR=CRPb+CRCd+CRAs is used to calculate the combined carcinogenic risk entropy TCR generated by the carcinogenic heavy metals in the traditional Chinese medicine to be evaluated; wherein CRCb, CRCd and CRAs are the chronic carcinogenic risk entropies of the carcinogenic heavy metals lead, cadmium and arsenic in the traditional Chinese medicine to be evaluated, respectively.

[0086] Step 105: Perform risk assessment based on the chronic exposure non-carcinogenic risk entropy, the combined non-carcinogenic risk entropy, the chronic carcinogenic risk entropy and the combined carcinogenic risk entropy of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated.

[0087] Risk assessment can be performed based on the chronic exposure non-carcinogenic risk entropy HQ, the combined non-carcinogenic risk entropy HI, the chronic carcinogenic risk entropy CR and the combined carcinogenic risk entropy TCR of the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated.

[0088] In addition, the present invention is based on existing theoretical knowledge and combines the HI evaluation model (3) to perform sensitivity analysis to evaluate the impact of each input parameter in the model on the output result HI, so as to find out the sensitivity factors that have a significant impact on the output result among many factors. Sensitivity analysis based on variance analysis is to decompose the total variation of the output result into the single variation of the input value (first-order effect) and the variation of the interaction (second-order effect), and to evaluate the impact of a single variable and its interaction on the output result, and the result is represented by the Sobol score (Score).

[0089] Therefore, the method further comprises:

[0090] A sensitivity analysis is performed based on the combined non-carcinogenic risk entropy HI generated by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, and key factors for reducing the health risks caused by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated are determined.

[0091] The method of the present invention can realize the exploration of heavy metals with exposure risks in the Chinese medicine Curcuma zedoaria, and evaluate the carcinogenic risk of their combined exposure. The probability analysis method is used in the exposure assessment. The model (1) uses the concentration of heavy metals in Chinese medicine, the frequency of use of Chinese medicine, the years of use and the dosage of Chinese medicine, realizes a risk assessment calculation method that conforms to the characteristics of Chinese medicine use, makes up for the uncertainty problem in the point assessment calculation, and achieves the purpose of quantifying the uncertainty in the assessment process through random simulation sampling, thereby improving the accuracy of risk assessment. The method of the present invention also finds the key factors for reducing the health risks caused by heavy metals in the Chinese medicine Curcuma zedoaria through sensitivity analysis, and provides theoretical support for regulatory authorities to formulate corresponding control measures and standards.

[0092] The following uses a specific embodiment to introduce the implementation process of the heavy metal probability risk assessment method of the rhizome Chinese medicine Curcuma zedoaria of the present invention.

[0093] The present invention provides a framework and method for heavy metal risk assessment of rhizomes of traditional Chinese medicine. Figure 2 Schematic diagram of the heavy metal probability risk assessment framework of the traditional Chinese medicine Curcuma zedoaria provided in an embodiment of the present invention. Figure 1 and Figure 2 The method of the present invention combines the characteristics of Chinese medicine use, including the frequency of Chinese medicine use, processing process, and Chinese medicine dosage, to conduct a probability assessment of the exposure risks of multiple heavy metals in Curcuma.

[0094] Collection of batches of the traditional Chinese medicine Curcuma: The samples came from Guangxi, Zhejiang, Sichuan, China and Vietnam, with a total of 32 batches of Curcuma medicinal materials. They were determined using "inductively coupled plasma mass spectrometry (ICP-MS)" and accompanying quality control was used to determine the applicability of the method. The results all met the residue detection requirements.

[0095] Results of the survey on the use characteristics of traditional Chinese medicine: Traditional Chinese medicine is usually taken for a long time to cure diseases. It is particularly important to combine the chronic exposure risk assessment of heavy metals in traditional Chinese medicine with the use characteristics of traditional Chinese medicine. Through the survey on the consumption and use characteristics of traditional Chinese medicine for typical populations across the country from 2015 to 2017, the survey and investigation of the consumption of traditional Chinese medicine for different groups of people in 11 provinces, 20,917 valid questionnaires were collected.

[0096] like Figure 1 and Figure 2 As shown in the figure, the probabilistic risk assessment method for heavy metals in the traditional Chinese medicine Curcuma zedoaria includes the following steps:

[0097] Step 1: Establish a chronic exposure assessment model based on the usage characteristics of Chinese medicine among the Chinese population:

[0098]

[0099] Where CDI is the daily exposure of an individual to a certain heavy metal, C is the concentration of a certain metal in a certain traditional Chinese medicine, M is the daily consumption of the traditional Chinese medicine, and P is the annual consumption days of the traditional Chinese medicine; Ed is the lifetime exposure to the traditional Chinese medicine, which is set to 20 years based on the questionnaire on traditional Chinese medicine consumption; t is the conversion rate of the metal released from the traditional Chinese medicine into the soup, and according to experiments, the conversion rates of Pb, Cd, As, Hg, and Cu are 14%, 14%, 35%, 24%, and 14%, respectively; AT is the average life expectancy in days, calculated as 70 years old, that is, 365*70=25550; W is the body weight (unit: Kg).

[0100] The chronic non-carcinogenic risk assessment of heavy metals in Curcuma zedoaria is calculated as follows:

[0101]

[0102] HI=HQPb+HQCd+HQAs+HQHg+HQCu

[0103] HQ is the risk entropy. When HQ>1, the risk of population exposure cannot be ignored. The HBGV of Pb, Cd, As, Hg, and Cu are 3.5, 1, 0.3, 0.5, and 40 μg / kgbw / day, respectively. In the present invention, it is considered that the metals ingested through traditional Chinese medicine are within the safe range if they do not exceed 10% of HBGV. At the same time, the cumulative non-carcinogenic health effect HI produced by a traditional Chinese medicine is the sum of the various health effects.

[0104] The formula for calculating the chronic carcinogenic risk of heavy metals in Curcuma zedoaria is as follows:

[0105] CR=CDI*SF

[0106] TCR=CRPb+CRCd+CRAs

[0107] The calculation formula for the lifetime carcinogenic risk CR of heavy metals is shown above, where the SFs of Pb, Cd, and As are 0.0000085, 0.0061, and 0.0015 (μg / kg / day), respectively. -1 The cumulative carcinogenic effect TCR produced by the three carcinogenic metals is the sum of the individual carcinogenic effects. It is generally believed that CR>10 -4 Or CR>10 -6 , the carcinogenic health effects it produces cannot be ignored.

[0108] Step 2: Data preprocessing: Based on the results of the questionnaire survey on the characteristics of Chinese medicine use, the mean and variance of the population's weight and number of days of Chinese medicine consumption were calculated, and the parameters α and β in the beta binomial distribution were further estimated.

[0109] After obtaining the concentration of each heavy metal in the traditional Chinese medicine Curcuma zedoaria, a box plot of the concentration data of each heavy metal is drawn, such as Figure 3As shown, outliers are screened out and the mean is used instead of the outliers for subsequent calculations. Check the probability distribution and cumulative distribution function diagrams of the concentration data, construct four skewed distributions and draw probability density distribution diagrams, qq diagrams, cumulative distribution functions and pp diagrams, perform goodness of fit tests, and select the distribution type that best fits the data characteristics, such as Figure 4 The results of Curcuma zedoaria and lead were consistent with Weibull distribution.

[0110] Step 3: Based on the exposure assessment model in step 1 and the data obtained in step 2, calculate the different heavy metal exposure levels of Curcuma zedoaria for different populations.

[0111] Table 1 Chronic exposure intake of heavy metal lead in the traditional Chinese medicine Curcuma zedoaria (μg / kg bw / day)

[0112]

[0113] Among them, Min, Max, and Mean represent the minimum, maximum, and mean of the chronic exposure intake of the traditional Chinese medicine Polygonatum odoratum, respectively; P25, P50, P75, P90, P95, and P99 represent the 25th, 50th, 75th, 90th, 95th, and 99th percentiles of the chronic exposure intake of the traditional Chinese medicine Polygonatum odoratum, respectively.

[0114] Step 4: Based on the calculated chronic exposure, calculate the non-carcinogenic and carcinogenic risks of each heavy metal in Curcuma zedoaria.

[0115] Table 2 Risk entropy (HQ) for non-carcinogenic risk assessment of heavy metal lead in Curcuma zedoaria

[0116]

[0117] Table 3 Carcinogenic risk assessment (CR) of heavy metal lead in the traditional Chinese medicine Curcuma zedoaria

[0118]

[0119] Step 5: Evaluate the non-carcinogenic and carcinogenic risks of combined exposure to heavy metals in Curcuma zedoaria.

[0120] Table 4 Non-carcinogenic risk assessment (HI) of combined exposure to heavy metals in the traditional Chinese medicine Curcuma zedoaria

[0121]

[0122] Table 5 Carcinogenic risk assessment (TCR) of combined exposure to heavy metals in the traditional Chinese medicine Curcuma zedoaria

[0123]

[0124] Table 6 Proportion of people with high exposure to heavy metals in the traditional Chinese medicine Curcuma

[0125]

[0126] Step 6: Sensitivity analysis.

[0127] Table 7 Results of sensitivity analysis of heavy metal HI in traditional Chinese medicine Curcuma zedoaria

[0128]

[0129] In Table 7, main effect and total effect represent the first-order effect and total effect of a single variable, respectively.

[0130] The present invention adopts a questionnaire on the use of Chinese medicine among the Chinese population, and incorporates the consumption of Chinese medicine that conforms to China's national conditions into the exposure assessment model; in the probability assessment model (1) proposed by the invention, the beta binomial distribution proposed for the number of days of Chinese medicine consumption takes into account the probability differences of different individuals in the population taking Chinese medicine; the entire model of the present invention adopts a probability assessment method, which is not limited to point assessment of exposure, but can calculate different exposure levels in the population and the proportion of the population exceeding a certain limit, so as to achieve the purpose of quantifying the uncertainty existing in the assessment process and improve the accuracy of risk assessment.

[0131] Based on the heavy metal probability risk assessment method of the rhizome Chinese medicine Curcuma zedoaria provided by the present invention, the present invention also provides a heavy metal probability risk assessment system of the rhizome Chinese medicine Curcuma zedoaria, see Fig.11 , the system comprising:

[0132] An exposure assessment model building module 1101 is used to build a chronic exposure assessment model;

[0133] The empirical distribution fitting module 1102 is used to obtain the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated and the intake amount and intake frequency of the Chinese medicine to be evaluated by using the empirical distribution fitting method; the Chinese medicine to be evaluated includes the root and stem Chinese medicine Curcuma; the heavy metals to be evaluated include lead, cadmium, arsenic, mercury and copper; the intake amount of the Chinese medicine to be evaluated is the daily consumption of the Chinese medicine to be evaluated; the intake frequency of the Chinese medicine to be evaluated is the annual consumption days of the Chinese medicine to be evaluated;

[0134] A heavy metal exposure calculation module 1103 is used to calculate the daily exposure of the heavy metal to be evaluated in the Chinese medicine to be evaluated using the chronic exposure assessment model according to the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated and the intake amount and intake frequency of the Chinese medicine to be evaluated;

[0135] A heavy metal non-carcinogenic and carcinogenic risk calculation module 1104 is used to calculate the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metal to be evaluated in the Chinese medicine to be evaluated according to the daily exposure amount of the heavy metal to be evaluated in the Chinese medicine to be evaluated;

[0136] The heavy metal non-carcinogenic and carcinogenic risk assessment module 1105 is used to perform risk assessment based on the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metal to be assessed in the traditional Chinese medicine to be assessed.

[0137] The exposure assessment model building module 1101 specifically includes:

[0138] An exposure assessment model building unit is used to build the chronic exposure assessment model according to the usage characteristics of Chinese medicine among the Chinese population Wherein, CDI is the daily exposure amount of the heavy metal to be evaluated in the Chinese medicine to be evaluated, P is the annual consumption days of the Chinese medicine to be evaluated, Ed is the lifetime exposure period of the Chinese medicine to be evaluated, M is the daily consumption of the Chinese medicine to be evaluated, C is the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated, t is the conversion rate of the heavy metal to be evaluated from the Chinese medicine to the soup, AT is the average life expectancy of the population, and W is the body weight.

[0139] The heavy metal non-carcinogenic and carcinogenic risk calculation module 1104 specifically includes:

[0140] The chronic exposure non-carcinogenic risk entropy calculation unit is used to calculate the daily exposure amount CDI of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated, using the formula Calculate the chronic exposure non-carcinogenic risk entropy HQ of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated; wherein HBGV is the health guidance value of the heavy metal to be evaluated;

[0141] A combined non-carcinogenic risk entropy calculation unit is used to calculate the combined non-carcinogenic risk entropy HI generated by the heavy metals to be evaluated in the Chinese medicine to be evaluated according to the chronic exposure non-carcinogenic risk entropy HQ of the heavy metals to be evaluated in the Chinese medicine to be evaluated, using the formula HI=HQPb+HQCd+HQAs+HQHg+HQCu; wherein HQPb, HQCd, HQAs, HQHg and HQCu are the chronic exposure non-carcinogenic risk entropies of the heavy metals lead, cadmium, arsenic, mercury and copper to be evaluated in the Chinese medicine to be evaluated, respectively;

[0142] A chronic carcinogenic risk calculation unit, used to calculate the chronic carcinogenic risk entropy CR of the heavy metal to be evaluated in the Chinese medicine to be evaluated according to the daily exposure CDI of the heavy metal to be evaluated in the Chinese medicine to be evaluated, using the formula CR=CDI*SF; wherein SF is a slope coefficient;

[0143] The combined carcinogenic risk entropy calculation unit is used to calculate the combined carcinogenic risk entropy TCR generated by the carcinogenic heavy metals in the traditional Chinese medicine to be evaluated according to the chronic carcinogenic risk entropy CR of the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, using the formula TCR=CRPb+CRCd+CRAs; wherein CRPb, CRCd and CRAs are the chronic carcinogenic risk entropies of the carcinogenic heavy metals lead, cadmium and arsenic in the traditional Chinese medicine to be evaluated, respectively.

[0144] The system further comprises:

[0145] The sensitivity analysis module is used to perform sensitivity analysis based on the combined non-carcinogenic risk entropy HI generated by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, and determine the key factors for reducing the health risks caused by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated.

[0146] In this specification, each embodiment is described in a progressive manner, and each embodiment focuses on the differences from other embodiments. The same or similar parts between the embodiments can be referred to each other. For the system disclosed in the embodiment, since it corresponds to the method disclosed in the embodiment, the description is relatively simple, and the relevant parts can be referred to the method part.

[0147] The principles and implementation methods of the present invention are described in this article using specific examples. The description of the above embodiments is only used to help understand the method and core idea of ​​the present invention. At the same time, for those skilled in the art, according to the idea of ​​the present invention, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A method for evaluating the probability risk of heavy metals in the rhizome Chinese medicine Curcuma zedoaria, characterized in that: include: Establishment of chronic exposure assessment model; The establishment of a chronic exposure assessment model specifically includes: The chronic exposure assessment model was established based on the usage characteristics of traditional Chinese medicine among the Chinese population Wherein, CDI is the daily exposure of the heavy metal to be evaluated in the Chinese medicine to be evaluated, P is the annual consumption days of the Chinese medicine to be evaluated, Ed is the lifetime exposure period of the Chinese medicine to be evaluated, M is the daily consumption of the Chinese medicine to be evaluated, C is the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated, t is the conversion rate of the heavy metal to be evaluated from the Chinese medicine to the soup, AT is the average life span of the population, and W is the body weight; The empirical distribution fitting method is used to obtain the concentration of the heavy metals to be evaluated in the Chinese medicine to be evaluated, as well as the intake and frequency of the Chinese medicine to be evaluated; the Chinese medicine to be evaluated includes the rhizome Chinese medicine Curcuma; the heavy metals to be evaluated include lead, cadmium, arsenic, mercury and copper; the intake of the Chinese medicine to be evaluated is the daily consumption of the Chinese medicine to be evaluated; the intake frequency of the Chinese medicine to be evaluated is the annual consumption days of the Chinese medicine to be evaluated; The concentration C of the heavy metals to be evaluated in Curcuma and the fitting ideas are as follows: first, a simple statistical description of the data is performed, and larger or smaller outliers are found through box plots, and the mean after removing the outliers is used to replace the outliers to improve the data fitting effect; then, the existing data of the heavy metals to be evaluated are used to perform goodness of fit tests of four skewed distributions, including Weibull distribution, Gamma distribution, lognormal distribution and exponential distribution, and the test results are combined with QQ graphs and PP graphs to see whether the data conforms to a certain distribution, and the best distribution of the concentration of the heavy metals to be evaluated is selected; if the heavy metals to be evaluated conform to a certain distribution, random numbers are generated from the distribution in the calculation of CDI, and if the heavy metal data to be evaluated do not conform to these four distributions, the original data is calculated by a sampling process with replacement in the CDI calculation; The idea of ​​fitting the empirical distribution of the daily consumption M of the Chinese medicine Curcuma is as follows: refer to the reference dosage range of Curcuma in the Pharmacopoeia for simulation estimation; the dosage of Curcuma in the Pharmacopoeia is stipulated as 6-9g, and only the upper and lower limits of the dosage are obtained. Assuming that the probability of the dosage of Curcuma in a prescription being 6-9g is uniform, then the uniform distribution is adopted; The idea of ​​fitting the empirical distribution of the annual consumption days P of the Chinese medicine Curcuma is as follows: for the target question "how many days out of 180 do individuals take Chinese medicine", assuming that the probability of individuals taking Chinese medicine every day in the group is π, then combined with statistical knowledge, the annual consumption days P of individuals taking Chinese medicine obeys the binomial distribution with parameters π and 180, P~B(π,180); however, since the probability π of individuals taking Chinese medicine every day is unknown, and the probability of taking Chinese medicine is different from individual to individual, it is further assumed that the probability π obeys the Beta distribution, π~Beta(α,β), then the annual consumption days P conforms to the constructed Beta binomial distribution, and the parameters α and β are estimated through the individual Chinese medicine consumption data of the surveyed population; According to the concentration of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated and the intake amount and intake frequency of the traditional Chinese medicine to be evaluated, the chronic exposure assessment model is used to calculate the daily exposure amount of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated; Calculating the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated according to the daily exposure amount of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated; Perform risk assessment based on the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated; In addition, based on the existing theoretical knowledge and combined with the HI evaluation model, a sensitivity analysis was conducted to evaluate the impact of each input parameter in the model on the output result HI, so as to find out the sensitivity factors that have an important impact on the output result among many factors; the sensitivity analysis based on variance analysis is to decompose the total variation of the output result into the single variation of the input value and the variation of the interaction, and evaluate the impact of a single variable and its interaction on the output result, and the result is expressed by the Sobol score Score; wherein HI is the combined non-carcinogenic risk entropy generated by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated.

2. The method according to claim 1, characterized in that The calculating of the chronic exposure non-carcinogenic risk entropy and the combined non-carcinogenic risk entropy of the heavy metal to be evaluated in the Chinese medicine to be evaluated according to the daily exposure amount of the heavy metal to be evaluated in the Chinese medicine to be evaluated specifically includes: According to the daily exposure CDI of the heavy metals to be evaluated in the Chinese medicine to be evaluated, the formula Calculate the chronic exposure non-carcinogenic risk entropy HQ of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated; wherein HBGV is the health guidance value of the heavy metal to be evaluated; According to the chronic exposure non-carcinogenic risk entropy HQ of the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, the formula HI=HQPb+HQCd+HQAs+HQHg+HQCu is used to calculate the joint non-carcinogenic risk entropy HI generated by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated; wherein HQPb, HQCd, HQAs, HQHg and HQCu are the chronic exposure non-carcinogenic risk entropies of the heavy metals lead, cadmium, arsenic, mercury and copper to be evaluated in the traditional Chinese medicine to be evaluated, respectively.

3. The method according to claim 2, characterized in that The calculating of the chronic carcinogenic risk entropy and the combined carcinogenic risk entropy of the heavy metal to be evaluated in the Chinese medicine to be evaluated according to the daily exposure amount of the heavy metal to be evaluated in the Chinese medicine to be evaluated specifically includes: According to the daily exposure amount CDI of the heavy metal to be evaluated in the Chinese medicine to be evaluated, the chronic carcinogenic risk entropy CR of the heavy metal to be evaluated in the Chinese medicine to be evaluated is calculated using the formula CR=CDI*SF; wherein SF is the slope coefficient; According to the chronic carcinogenic risk entropy CR of the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, the formula TCR=CRPb+CRCd+CRAs is used to calculate the combined carcinogenic risk entropy TCR generated by the carcinogenic heavy metals in the traditional Chinese medicine to be evaluated; wherein CRPb, CRCd and CRAs are the chronic carcinogenic risk entropies of the carcinogenic heavy metals lead, cadmium and arsenic in the traditional Chinese medicine to be evaluated, respectively.

4. A heavy metal probability risk assessment system for rhizome Chinese medicine Curcuma zedoaria, characterized in that: include: Exposure assessment model building module, used to build chronic exposure assessment models; The exposure assessment model establishment module specifically includes: An exposure assessment model building unit is used to build the chronic exposure assessment model according to the usage characteristics of Chinese medicine among the Chinese population Wherein, CDI is the daily exposure of the heavy metal to be evaluated in the Chinese medicine to be evaluated, P is the annual consumption days of the Chinese medicine to be evaluated, Ed is the lifetime exposure period of the Chinese medicine to be evaluated, M is the daily consumption of the Chinese medicine to be evaluated, C is the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated, t is the conversion rate of the heavy metal to be evaluated from the Chinese medicine to the soup, AT is the average life span of the population, and W is the body weight; An empirical distribution fitting module is used to obtain the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated and the intake and intake frequency of the Chinese medicine to be evaluated by using the empirical distribution fitting method; the Chinese medicine to be evaluated includes the rhizome Chinese medicine Curcuma; the heavy metals to be evaluated include lead, cadmium, arsenic, mercury and copper; the intake of the Chinese medicine to be evaluated is the daily consumption of the Chinese medicine to be evaluated; the intake frequency of the Chinese medicine to be evaluated is the annual consumption days of the Chinese medicine to be evaluated; The concentration C of the heavy metals to be evaluated in Curcuma and the fitting ideas are as follows: first, a simple statistical description of the data is performed, and larger or smaller outliers are found through box plots, and the mean after removing the outliers is used to replace the outliers to improve the data fitting effect; then, the existing data of the heavy metals to be evaluated are used to perform goodness of fit tests of four skewed distributions, including Weibull distribution, Gamma distribution, lognormal distribution and exponential distribution, and the test results are combined with QQ graphs and PP graphs to see whether the data conforms to a certain distribution, and the best distribution of the concentration of the heavy metals to be evaluated is selected; if the heavy metals to be evaluated conform to a certain distribution, random numbers are generated from the distribution in the calculation of CDI, and if the heavy metal data to be evaluated do not conform to these four distributions, the original data is calculated by a sampling process with replacement in the CDI calculation; The idea of ​​fitting the empirical distribution of the daily consumption M of the Chinese medicine Curcuma is as follows: refer to the reference dosage range of Curcuma in the Pharmacopoeia for simulation estimation; the dosage of Curcuma in the Pharmacopoeia is stipulated as 6-9g, and only the upper and lower limits of the dosage are obtained. Assuming that the probability of the dosage of Curcuma in a prescription being 6-9g is uniform, then the uniform distribution is adopted; The idea of ​​fitting the empirical distribution of the annual consumption days P of the Chinese medicine Curcuma is as follows: for the target question "how many days out of 180 do individuals take Chinese medicine", assuming that the probability of individuals taking Chinese medicine every day in the group is π, then combined with statistical knowledge, the annual consumption days P of individuals taking Chinese medicine obeys the binomial distribution with parameters π and 180, P~B(π,180); however, since the probability π of individuals taking Chinese medicine every day is unknown, and the probability of taking Chinese medicine is different from individual to individual, it is further assumed that the probability π obeys the Beta distribution, π~Beta(α,β), then the annual consumption days P conforms to the constructed Beta binomial distribution, and the parameters α and β are estimated through the individual Chinese medicine consumption data of the surveyed population; A heavy metal exposure calculation module, used to calculate the daily exposure of the heavy metal to be evaluated in the Chinese medicine to be evaluated using the chronic exposure assessment model according to the concentration of the heavy metal to be evaluated in the Chinese medicine to be evaluated and the intake and frequency of the Chinese medicine to be evaluated; A heavy metal non-carcinogenic and carcinogenic risk calculation module, used to calculate the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated according to the daily exposure amount of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated; A heavy metal non-carcinogenic and carcinogenic risk assessment module, used to conduct risk assessment based on the chronic exposure non-carcinogenic risk entropy, combined non-carcinogenic risk entropy, chronic carcinogenic risk entropy and combined carcinogenic risk entropy of the heavy metal to be assessed in the traditional Chinese medicine to be assessed; In addition, based on the existing theoretical knowledge and combined with the HI evaluation model, a sensitivity analysis was conducted to evaluate the impact of each input parameter in the model on the output result HI, so as to find out the sensitivity factors that have an important impact on the output result among many factors; the sensitivity analysis based on variance analysis is to decompose the total variation of the output result into the single variation of the input value and the variation of the interaction, and evaluate the impact of a single variable and its interaction on the output result, and the result is expressed by the Sobol score Score; wherein HI is the combined non-carcinogenic risk entropy generated by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated.

5. The system according to claim 4, characterized in that The heavy metal non-carcinogenic and carcinogenic risk calculation module specifically includes: The chronic exposure non-carcinogenic risk entropy calculation unit is used to calculate the daily exposure amount CDI of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated, using the formula Calculate the chronic exposure non-carcinogenic risk entropy HQ of the heavy metal to be evaluated in the traditional Chinese medicine to be evaluated; wherein HBGV is the health guidance value of the heavy metal to be evaluated; The combined non-carcinogenic risk entropy calculation unit is used to calculate the combined non-carcinogenic risk entropy HI generated by the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated according to the chronic exposure non-carcinogenic risk entropy HQ of the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, using the formula HI=HQPb+HQCd+HQAs+HQHg+HQCu; wherein HQPb, HQCd, HQAs, HQHg and HQCu are the chronic exposure non-carcinogenic risk entropies of the heavy metals lead, cadmium, arsenic, mercury and copper to be evaluated in the traditional Chinese medicine to be evaluated, respectively.

6. The system according to claim 5, characterized in that The heavy metal non-carcinogenic and carcinogenic risk calculation module also includes: A chronic carcinogenic risk calculation unit, used to calculate the chronic carcinogenic risk entropy CR of the heavy metal to be evaluated in the Chinese medicine to be evaluated according to the daily exposure CDI of the heavy metal to be evaluated in the Chinese medicine to be evaluated, using the formula CR=CDI*SF; wherein SF is a slope coefficient; The combined carcinogenic risk entropy calculation unit is used to calculate the combined carcinogenic risk entropy TCR generated by the carcinogenic heavy metals in the traditional Chinese medicine to be evaluated according to the chronic carcinogenic risk entropy CR of the heavy metals to be evaluated in the traditional Chinese medicine to be evaluated, using the formula TCR=CRPb+CRCd+CRAs; wherein CRPb, CRCd and CRAs are the chronic carcinogenic risk entropies of the carcinogenic heavy metals lead, cadmium and arsenic in the traditional Chinese medicine to be evaluated, respectively.

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