Probability risk assessment method and system for ochratoxin A in traditional Chinese medicine

Abstract

The invention relates to the technical field of traditional Chinese medicine risk assessment, in particular to an ochratoxin A probability risk assessment method and system. The method mainly comprises the following steps: acquiring optimal distribution of annual intake of traditional Chinese medicine and optimal distribution of pollution level; establishing an exposure evaluation model M of the ochratoxin A in the traditional Chinese medicine to be evaluated; obtaining the daily exposure distribution of the ochratoxin A in the traditional Chinese medicine to be evaluated under the non-tumor effect and the tumor effect; and calculating risk entropy RQ according to the daily exposure distribution, comparing the risk entropy RQ with a safety standard value, and evaluating the risk level of the ochratoxin A in the traditional Chinese medicine. According to the method, a risk assessment model about the ochratoxin A in the traditional Chinese medicine is established based on Monte Carlo simulation, the risk assessment accuracy of the ochratoxin A in the traditional Chinese medicine can be greatly improved, and technical support is provided for government and traditional Chinese medicine management institutions to risk management of the ochratoxin A in the traditional Chinese medicine.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine risk assessment, in particular to a probability risk assessment method and system for ochratoxin A. BACKGROUND

[0002] Ochratoxin is a metabolite produced by ochratoxin and sulfur color aspergillus, and there are four kinds, among which ochratoxin A (OTA) has the largest toxicity and the largest toxic amount, and has teratogenicity, carcinogenicity, immunosuppression and liver and kidney toxicity. The International Cancer Research Agency (IARC) has listed ochratoxin A as a possible human carcinogen (2B). The contamination rate of ochratoxin A in traditional Chinese medicine is high. In order to protect public health and ensure drug safety, the European Union has set a maximum allowable level of 15 μg / kg for ochratoxin A in nutmeg, ginger, turmeric and chili.

[0003] In the field of determination of mycotoxin residues, the usual determination object is mainly food, and the risk assessment method of ochratoxin A in food is mainly point assessment method. Specifically, the content of ochratoxin A in food is multiplied by the food intake to obtain the exposure of ochratoxin A, and compared with the harmless reference amount of ochratoxin A. For traditional Chinese medicine, it is not often continuously ingested, and is usually taken in the form of decoction, etc., and the amount of ochratoxin A transferred to the decoction during the decoction process of traditional Chinese medicine and the exposure period and exposure frequency of traditional Chinese medicine need to be considered. The above point assessment method has the disadvantage of being unable to reflect the variability and uncertainty of exposure assessment, so it cannot well assess the exposure risk of ochratoxin A in traditional Chinese medicine. SUMMARY

[0004] The purpose of the present application is to provide a probability risk assessment method and system for ochratoxin A in traditional Chinese medicine, which establishes a risk assessment model for ochratoxin A in traditional Chinese medicine based on Monte Carlo simulation, can greatly improve the risk assessment accuracy of ochratoxin A in traditional Chinese medicine, and provide technical support for government risk management of ochratoxin A in traditional Chinese medicine.

[0005] To achieve the above purpose, the present application provides the following scheme:

[0006] A probability risk assessment method for ochratoxin A in traditional Chinese medicine, characterized in that the method comprises:

[0007] S01, obtaining the annual intake CS of the traditional Chinese medicine to be evaluated of the consumer population Y , the pollution level L of ochratoxin A t and the transfer rate t of ochratoxin A in the decoction process;

[0008] S02, the annual intake CS of the traditional Chinese medicine Y and the pollution level L tdistribution function fitting is performed, and the optimal distribution of annual intake of traditional Chinese medicine and the optimal distribution of pollution level are obtained;

[0009] S03, an exposure assessment model M of ochratoxin A in the traditional Chinese medicine to be evaluated is established;

[0010] S04, according to the optimal distribution of annual intake of traditional Chinese medicine, the optimal distribution of pollution level and the transfer rate t, combined with the exposure assessment model M, the daily exposure amount distribution of ochratoxin A in the traditional Chinese medicine to be evaluated under non-tumor effect and tumor effect is calculated and obtained;

[0011] S05, according to the daily exposure amount distribution, the risk entropy RQ is calculated, and the risk level of ochratoxin A in the traditional Chinese medicine is evaluated by comparing the risk entropy RQ with the safety standard value.

[0012] Therefore, for a certain traditional Chinese medicine to be evaluated, the annual intake level of different populations can be calculated according to the prescription data of the population consuming the traditional Chinese medicine to be evaluated, and the optimal distribution of annual intake of traditional Chinese medicine C SY is obtained, and the sample collection and experiment based on the mycotoxin determination method are performed on the prescription traditional Chinese medicine, and the pollution level L t of ochratoxin A and the transfer rate t of ochratoxin A in the decoction process are obtained.

[0013] After obtaining a large amount of annual intake data CS Y of traditional Chinese medicine, the pollution level L t of ochratoxin A, the distribution function fitting is performed using computer software, and the optimal distribution of the above two simulation data is obtained. Then, the exposure assessment model M of ochratoxin A in the traditional Chinese medicine to be evaluated is established, which is used to calculate the daily exposure amount of ochratoxin A in the traditional Chinese medicine to be evaluated. In the optimal distribution of the above-mentioned annual intake CS Y of traditional Chinese medicine, the optimal distribution of pollution level L t , a plurality of groups of data are extracted and the daily exposure amount data are calculated according to the exposure assessment model M of ochratoxin A, and the daily exposure amount distribution data are fitted.

[0014] Then, the daily exposure amount data are selected from the daily exposure amount distribution, the risk entropy RQ is calculated, and the risk entropy RQ is compared with the safety standard. If the risk entropy RQ value is greater than the safety standard value, it indicates that the risk level of ochratoxin A in the traditional Chinese medicine to be evaluated is a health risk, and the government or the traditional Chinese medicine management institution needs to actively intervene.

[0015] This probabilistic risk assessment method comprehensively considers consumers' annual intake of a specific traditional Chinese medicine (TCM), the concentration of ochratoxin A contamination in the TCM, and the transfer level of ochratoxin A during the decoction process. Through the exposure assessment model M, it accurately calculates and ultimately obtains the risk entropy RQ for ochratoxin A. Using this risk entropy RQ as a scientific evaluation standard, a comprehensive, scientific, and accurate assessment of the risk level of ochratoxin A in TCM is conducted, thereby providing technical support for the government's risk management of ochratoxin A in TCM.

[0016] As a preferred embodiment of the present invention, in S01, the annual intake of traditional Chinese medicine CS Y The specific method of obtaining it is as follows:

[0017]

[0018] Where n is the number of prescriptions for each consumer of the traditional Chinese medicine to be evaluated, and CS D (i) represents the weight of each dose of the Chinese medicine to be evaluated in the i-th prescription, and Days(i) represents the number of days of intake of the Chinese medicine to be evaluated in the i-th prescription.

[0019] Therefore, by introducing actual data from the actual prescription process of the Chinese herbal medicine to be evaluated, and combining this with the number of days of herbal medicine intake, a scientific and accurate annual intake (CS) of Chinese herbal medicine can be obtained. Y .

[0020] As a preferred embodiment of the present invention, the exposure assessment model M includes a non-tumor effect exposure assessment model m1 and a tumor effect exposure assessment model m2.

[0021] Therefore, the carcinogenicity of ochratoxin A is related to the expected exposure time. For the non-tumor effect exposure assessment model m1, it is not necessary to consider the lifetime cumulative exposure; for the tumor effect exposure assessment model m2, it is necessary to incorporate the lifetime exposure years of taking this traditional Chinese medicine and the average lifespan for comprehensive assessment. The two will be calculated separately to obtain different risk entropies RQ, and will be compared using different safety standard values.

[0022] As a preferred embodiment of the present invention, the non-tumor effect exposure assessment model m1 is specifically as shown in formula (2-1);

[0023]

[0024] The tumor effect exposure assessment model m2 is specifically shown in equation (2-2);

[0025]

[0026] Wherein, EDI is the daily exposure to non-tumor effects; EDIcancer is the daily exposure to tumor effects; BW is the consumer's weight; 365 is the number of days in a year; ED is the lifetime exposure years of taking this traditional Chinese medicine; and AY is the average lifespan in years, with a value of 70.

[0027] Therefore, since the tumor effect needs to take into account lifetime cumulative exposure, EDI represents the estimated daily intake per kilogram of body weight for long-term chronic exposure, which represents the daily exposure for non-tumor effects; EDIcancer represents the daily intake per kilogram of body weight for lifetime exposure, which represents the daily exposure for tumor effects; EDI and EDIcancer together can be used to target the degree of ochratoxin A exposure based on non-tumor effects and tumor effects, respectively.

[0028] After acquiring a large amount of EDI and EDIcancer data, the corresponding daily exposure distribution was obtained using computational software. The model was developed using R software, employing 1000 simulations × 10000 iterations to simulate the risk of ochratoxin A in the traditional Chinese medicine to be evaluated in both the uncertainty and variability dimensions. Specifically, this refers to the risk from the annual intake C of traditional Chinese medicine. SY Optimal distribution and pollution level L t 10,000 sets of data are randomly selected from the optimal distribution and calculated. The number of calculations is 1,000, which yields 10,000 EDI or EDIcancer data. Function fitting operations are then performed on both to obtain the daily exposure distribution under non-tumor effect and tumor effect.

[0029] To reflect the uncertainty of various statistical data regarding the risk of ochratoxin A from the consumption of traditional Chinese medicine under assessment, this method uses the mean, median, and 95th percentile of each simulation (10,000 iterations) as point estimates, and the 2.5th and 97.5th percentiles of the mean, median, and 95th percentile of 1,000 simulations to establish 95% confidence intervals (CIs). The P50, P95, and mean values ​​from the daily exposure distribution are selected as the basis for calculating the risk entropy RQ.

[0030] As a preferred embodiment of the present invention, when obtaining the optimal distribution of annual intake of traditional Chinese medicine and the optimal distribution of pollution levels, the fitting data are tested using three test methods: Kolmogorov-Smirnov, Anderson-Darling, and Chi-Squared.

[0031] The Kolmogorov-Smirnov test, also known as the KS test, is a statistical test used to compare a sample distribution to a reference probability distribution. It is commonly used to determine whether a dataset follows a specific distribution, such as a normal distribution. The Anderson-Darling test is a statistical test used to assess whether a given sample of data follows a specific probability distribution, such as a normal distribution. It is an extension of the Kolmogorov-Smirnov test. The Anderson-Darling test assigns more weight to the tails of the distribution and is more sensitive to bias in these regions compared to the KS test. The Chi-Squared test is a statistical method used to determine whether a significant association exists between categorical variables. It is commonly used to analyze the relationship between two categorical variables by comparing the observed frequencies of the data with the expected frequencies when there is no association between the variables.

[0032] The above three testing methods can be used to test the optimal distribution of annual intake of traditional Chinese medicine and the optimal distribution of pollution levels, ensuring the accuracy and scientific validity of the optimal distribution.

[0033] As a preferred embodiment of the present invention, a risk threshold TR determination step is further included between S04 and S05, which specifically includes:

[0034] The risk threshold TR is calculated based on the MOE threshold (TMOE) for different toxic effects;

[0035]

[0036] Among them, BMDL 10 The lower limit of the baseline dose is 10%; TMOE is the threshold for toxic effects.

[0037] The 10% lower limit of the baseline dose can be adopted from the 10% lower limit of the baseline dose for ochratoxin A in a well-regarded study report, for example, the 10% lower limit of the baseline dose for non-tumor toxicity and tumor toxicity in the EFSA 2020 Risk Assessment Report (BMDL). 10 4.73 μg ochratoxin A / kgbw and 14.5 μg ochratoxin A / kgbw were used, respectively. The Total Motion Effect (TMOE) threshold was used, and based on the MOE thresholds (TMOE) for non-tumor toxicity and tumor toxicity in the EFSA 2020 Risk Assessment Report, it was set to 200 and 10000, respectively. Dividing the two yielded the risk threshold TR.

[0038] As a preferred embodiment of the present invention, the method for calculating the risk entropy RQ based on non-tumor effects and tumor effects in S05 is specifically as follows:

[0039]

[0040]

[0041] Where RQ is the risk entropy RQ; TR is the risk threshold; EDI is the daily exposure to non-tumor effects; and EDIcancer is the daily exposure to tumor effects.

[0042] Therefore, EDI and EDIcancer data located at specific distribution positions are extracted from the daily exposure distribution under non-tumor and tumor effects. After dividing these data by the risk threshold TR under non-tumor and tumor effects, the risk entropy RQ under non-tumor and tumor effects is obtained. The risk entropy RQ is compared with the set standard value. If the value exceeds the set standard value, it indicates that there is a significant exposure risk of ochratoxin A in this traditional Chinese medicine within the confidence interval, and the government or traditional Chinese medicine management agency should take effective measures to intervene.

[0043] This invention also provides a probability risk assessment system for ochratoxin A in traditional Chinese medicine, characterized in that the system comprises:

[0044] The data acquisition module is used to obtain the annual intake (CS) of the target traditional Chinese medicine (TCM) of the consumer population. Y Ochratoxin A contamination level L t The transfer rate t of ochratoxin A during the decoction process;

[0045] The optimal distribution fitting module is used to determine the annual intake CS of the traditional Chinese medicine. Y and the pollution level L t We performed distribution function fitting and obtained the optimal distribution of annual intake of traditional Chinese medicine and the optimal distribution of pollution level.

[0046] The daily exposure calculation module is used to establish an exposure assessment model M, and calculate the daily exposure distribution of ochratoxin A in the Chinese medicine to be assessed under non-tumor and tumor effects based on the optimal distribution of annual intake of the Chinese medicine, the optimal distribution of pollution level, and the transfer rate t, combined with the exposure assessment model M.

[0047] The risk entropy RQ calculation module is used to calculate and obtain the risk entropy RQ based on the daily exposure distribution.

[0048] The risk assessment module is used to compare the risk entropy RQ with the safety standard value to assess the risk level of ochratoxin A in traditional Chinese medicine.

[0049] In summary, the present invention has the following beneficial effects:

[0050] This probabilistic risk assessment method and system comprehensively considers consumers' annual intake (CS) of a specific traditional Chinese medicine. Y The concentration of ochratoxin A in this traditional Chinese medicine was L. tThe study also investigated the transfer level t of ochratoxin A during the decoction process. Through precise simulation and calculation using the exposure assessment model M, the risk entropy RQ for ochratoxin A under both non-tumor and tumor effects was obtained. Using this risk entropy RQ as a scientific assessment standard, a comprehensive, scientific, and accurate assessment of the risk level of ochratoxin A in traditional Chinese medicine was conducted. This provided technical support for government and traditional Chinese medicine management agencies in the risk management of ochratoxin A in traditional Chinese medicine. Attached Figure Description

[0051] Figure 1 This is a flowchart of the probability risk assessment method.

[0052] Figure 2 This is a block diagram of the probability risk assessment system;

[0053] Figure 3 This is a map showing the overall distribution of annual intake of Astragalus membranaceus.

[0054] Figure 4 A distribution map of ochratoxin A contamination levels in Astragalus membranaceus;

[0055] Figure 5 This is a daily exposure distribution map of ochratoxin A in Astragalus membranaceus during lifetime exposure. Detailed Implementation

[0056] Preferred embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. Any person may implement the present disclosure in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0057] In this embodiment, Astragalus membranaceus was selected as the Chinese herbal medicine to be evaluated, and relevant data on Astragalus membranaceus were introduced to conduct a risk assessment of ochratoxin A.

[0058] First, based on the prescription data of the Astragalus consumer group to be evaluated, the intake data of each consumer was statistically analyzed. The formulas for annual intake and annual intake days are as follows:

[0059]

[0060]

[0061] Where n is the number of prescriptions for each consumer, CS D (i) represents the weight of each dose of Astragalus membranaceus in the i-th prescription, Days(i) represents the number of days of Astragalus membranaceus intake in the i-th prescription, and Days represents the number of days of intake in a year.

[0062] Next, based on the survey data on the annual intake of Astragalus membranaceus by consumers and the concentration data of ochratoxin A in Astragalus membranaceus, a distribution function was fitted to obtain the optimal distribution.

[0063] Prescription data were derived from a population of 258,164 consumers of Astragalus membranaceus. In 2019, the annual intake (P50, P95, and average) of Astragalus membranaceus was 420 g / year, 4200 g / year, and 1079 g / year, respectively. The number of days of intake (P50, P95, and average) was 27 days, 168 days, and 45.8 days, respectively. The overall distribution of annual Astragalus membranaceus intake is shown below. Figure 3 As shown.

[0064] Ochratoxin A contamination level in Astragalus membranaceus: Simulated data were obtained from 187 Astragalus membranaceus samples randomly collected from Shanghai medicinal herb markets, processing plants, hospitals, and pharmacies. After sampling, the samples were sealed and stored in the laboratory after being pulverized at 4℃. The detection method referenced the General Rules, Part IV, of the 2020 edition of the Chinese Pharmacopoeia. <2351> Mycotoxin assay. The detection rate of ochratoxin A in 187 Astragalus membranaceus samples was 32.45% (61 / 187), ranging from <0.2 to 1220 μg / kg. The mean, median, and p95 values ​​of ochratoxin A in positive samples were 56.2 μg / kg, 5.1 μg / kg, and 480.5 μg / kg, respectively. Figure 4 This is a map showing the distribution of ochratoxin A contamination levels in Astragalus membranaceus.

[0065] Based on the annual intake data of Astragalus membranaceus consumers and the concentration data of ochratoxin A in Astragalus membranaceus, distribution functions were fitted to obtain the optimal distribution of annual intake and optimal distribution of pollution levels. The data were tested using three methods: Chi-Squared, Anderson-Darling, and Kolmogorov-Smirnov, and the optimal fitted distribution was selected. The annual consumption data of Astragalus membranaceus were tested using the three methods, and the optimal fitted distributions were all inverse Gaussian distributions.

[0066] Subsequently, an exposure assessment model M for ochratoxin A in the Chinese herbal medicine to be evaluated was established. The exposure assessment model M includes a non-tumor effect exposure assessment model m1 and a tumor effect exposure assessment model m2.

[0067] Among them, the non-tumor effect exposure assessment model m1 is specifically shown in Equation (2-1);

[0068]

[0069] The tumor effect exposure assessment model m2 is shown in Equation (2-2);

[0070]

[0071] Wherein, EDI is the daily exposure for non-tumor effects; EDIcancer is the daily exposure for tumor effects; BW is the consumer's weight; 365 is the number of days in a year; ED is the lifetime exposure years of taking this Astragalus; and AY is the average lifespan in years, with a value of 70.

[0072] Because the tumor effect needs to take into account lifetime cumulative exposure, EDI represents the estimated daily intake per kilogram of body weight for long-term chronic exposure, which is equivalent to the daily exposure for non-tumor effects; EDIcancer represents the daily intake per kilogram of body weight for lifetime exposure, which is equivalent to the daily exposure for tumor effects; EDI and EDIcancer together can be used to target the level of ochratoxin A exposure based on non-tumor effects and tumor effects, respectively.

[0073] Table 1 shows the parameter values ​​for the exposure assessment model of ochratoxin A (OTA). 10,000 data sets were extracted from the optimal distributions of annual intake and pollution levels of the aforementioned traditional Chinese medicine (TCM), and the corresponding daily exposure distributions were obtained using computational software. The model was developed using R software, employing 1000 simulations × 10000 iterations to simulate the risk of ochratoxin A in the TCM to be assessed in both the uncertainty and variability dimensions. Specifically, 10,000 data sets were randomly extracted from the optimal distributions of annual intake and pollution levels of TCM and calculated 1000 times, yielding 10,000 EDI or EDIcancer data points. These data were then fitted with functions to obtain the daily exposure distributions under non-tumor and tumor effects. To reflect the uncertainty of various statistical data regarding the risk of ochratoxin A from Astragalus consumption, this study used the mean, median, and 95th percentile of each simulation (10,000 iterations) as point estimates, and the 2.5 and 97.5th percentiles of the mean, median, and 95th percentile of the 1,000 simulations to establish 95% confidence intervals (CIs).

[0074]

[0075] Table 1. Parameter values ​​for the exposure assessment model of ochratoxin A (OTA)

[0076] Based on the optimal distribution fitted to the annual intake data of Astragalus membranaceus and the optimal distribution fitted to the ochratoxin A data obtained from the survey, the chronic daily exposure distribution of ochratoxin A in Astragalus membranaceus was calculated, i.e., the daily exposure distribution without tumor effects. Figure 5The daily exposure distribution of ochratoxin A in Astragalus membranaceus during lifetime exposure is shown in the figure. The average daily exposure level of ochratoxin A was 0.730 ng / kg bw (95% CI: 0.567-0.909 ng / kg bw), the P50 value was 0.0072 ng / kg bw (95% CI: 0.0070-0.0075 ng / kg bw), and the P95 value was 1.21 ng / kg bw (95% CI: 1.07-1.39 ng / kg bw).

[0077] Because the tumor effect needs to be considered based on lifetime cumulative exposure, this embodiment calculates the average, P50, P95 and 95% confidence interval of lifetime exposure level of ochratoxin A in Astragalus membranaceus for exposure years of 1, 5, 10, 20 and 40 years respectively.

[0078] Next, based on the daily exposure distribution of ochratoxin A in Astragalus membranaceus, the risk entropy RQ based on non-tumor and tumor effects was calculated.

[0079] Calculate the risk threshold based on different toxicity effect MOE thresholds (TMOE): Among them, BMDL 10 The 10% lower limit of the baseline dose is used; TMOE is the threshold for toxic effects. The 10% lower limit of the baseline dose can be adopted from the 10% lower limit of the baseline dose for ochratoxin A in a well-regarded study report. For example, it can be based on the 10% lower limit of the baseline dose for non-tumor toxicities and tumor toxicities (BMDL) in the EFSA 2020 Risk Assessment Report. 10 4.73 μg ochratoxin A / kg bw and 14.5 μg ochratoxin A / kg bw were respectively used. The Total Motion Effect (TMOE) threshold was used, and based on the MOE thresholds for non-tumor and tumor effects (TMOE) in the EFSA 2020 Risk Assessment Report, it was set to 200 and 10000 respectively. Dividing the two yielded the risk threshold TR.

[0080] Next, the risk entropy RQ under non-tumor effects and tumor effects is calculated based on the risk threshold TR. The specific calculation method is as follows:

[0081]

[0082]

[0083] Where RQ is the risk entropy RQ; TR is the risk threshold; EDI is the daily exposure to non-tumor effects; and EDIcancer is the daily exposure to tumor effects.

[0084] Therefore, by extracting EDI and EDIcancer data located at specific distribution locations from the daily exposure distribution under non-tumor and tumor effects, such as the mean, P50 value, and P95 value, and dividing them by the risk thresholds TR under non-tumor and tumor effects, the risk entropy RQ under non-tumor and tumor effects is obtained.

[0085] For the risk characteristics of non-tumor effects, the mean risk entropy RQ, P50, and P95 values ​​were 0.031 (95% CI: 0.024–0.038), 3.0 × 10⁻⁶, and 3.0 × 10⁻⁶, respectively. -4 (95% CI: 3.0 × 10⁻⁶) -4 ~3.0×10 -4 ), 0.051 (95%CI: 0.045~0.059).

[0086] For the risk profile of tumor effects, the duration of exposure needs to be considered. The risk entropy RQ for different durations of exposure (1 year, 5 years, 10 years, 20 years, and 40 years) is shown in Table 2 for the exposure levels of ochratoxin A in Astragalus membranaceus for different lifetime exposure durations.

[0087]

[0088]

[0089] Table 2. Ochratoxin A exposure levels in Astragalus membranaceus at different lifetime exposure durations (unit: ng / kg bw)

[0090] Finally, the risk level of ochratoxin A in Astragalus membranaceus was assessed based on daily exposure and risk entropy RQ, which are based on non-tumor and tumor effects.

[0091] The mean daily exposure level of ochratoxin A in Astragalus membranaceus was extracted from the chronic daily exposure assessment distribution, with a mean of 0.730 ng / kg bw (95% CI: 0.567–0.909 ng / kg bw) and a p95 value of 1.21 ng / kg bw (95% CI: 1.07–1.39 ng / kg bw). According to NSF data, the risk entropy (RQ) for exposure to ochratoxin A in dietary supplements should be below 0.1. For non-tumor effects, the mean RQ for most consumer groups is less than 0.05, and the 95th percentile RQ is close to 0.05. Therefore, the non-tumor effects of ochratoxin A in Astragalus membranaceus pose a relatively low health risk to ordinary consumers. Regarding the tumor effect, when the exposure period is between 10 and 40 years, the risk entropy RQ range of ochratoxin A exposure in Astragalus membranaceus is 0.12 to 0.48, and the average risk entropy RQ range of ochratoxin A exposure in Astragalus membranaceus is 0.07 to 0.29. Both are close to or significantly exceed 0.1. Therefore, it can be concluded that the health risks related to the tumor effect of ochratoxin A are very high for long-term consumers of Astragalus membranaceus with an exposure period of 10 to 40 years, which requires attention from the government or Chinese medicine management agencies.

[0092] Several embodiments of this disclosure have been described above. These descriptions are exemplary and not exhaustive, and are not limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen to best explain the principles, practical applications, or technological improvements to the embodiments in the market, or to enable others skilled in the art to understand the embodiments disclosed herein.

Claims

1. A method for probabilistic risk assessment of ochratoxin A in traditional Chinese medicine, characterized in that the method... include: S01. Obtain the annual intake of Chinese herbal medicines (TCM) of the target consumer group (CS) Y Ochratoxin A contamination level L t The transfer rate t of ochratoxin A during the decoction process; S02, the annual intake of the aforementioned traditional Chinese medicine CS Y and the pollution level L t We performed distribution function fitting and obtained the optimal distribution of annual intake of traditional Chinese medicine and the optimal distribution of pollution level. S03. Establish an exposure assessment model M for ochratoxin A in the Chinese herbal medicine to be evaluated; S04. Based on the optimal distribution of annual intake of the traditional Chinese medicine, the optimal distribution of pollution level, and the transfer rate t, the daily exposure distribution of ochratoxin A in the traditional Chinese medicine to be evaluated under non-tumor and tumor effects is calculated using the exposure assessment model M. S05. Calculate the risk entropy RQ based on the daily exposure distribution, compare the risk entropy RQ with the safety standard value, and assess the risk level of ochratoxin A in traditional Chinese medicine.

2. The probability risk assessment method for ochratoxin A in traditional Chinese medicine according to claim 1, characterized in that, In S01, the annual intake of traditional Chinese medicine CS Y The specific method of obtaining it is as follows: Where n is the number of prescriptions per consumer for the Chinese medicine to be evaluated per year, and CS D (i) represents the weight of each dose of the Chinese medicine to be evaluated in the i-th prescription, and Days(i) represents the number of days of intake of the Chinese medicine to be evaluated in the i-th prescription.

3. The probability risk assessment method for ochratoxin A in traditional Chinese medicine according to claim 1, characterized in that, The exposure assessment model M includes a non-tumor effect exposure assessment model m1 and a tumor effect exposure assessment model m2.

4. The probability risk assessment method for ochratoxin A in traditional Chinese medicine according to claim 3, characterized in that, The non-tumor effect exposure assessment model m1 is specifically shown in equation (2-1); The tumor effect exposure assessment model m2 is specifically shown in equation (2-2); Wherein, EDI is the daily exposure to non-tumor effects; EDIcancer is the daily exposure to tumor effects; BW is the consumer's weight; 365 is the number of days in a year; ED is the lifetime exposure years of taking this traditional Chinese medicine; and AY is the average lifespan in years.

5. The probability risk assessment method for ochratoxin A in traditional Chinese medicine according to claim 1, characterized in that, To obtain the optimal distribution of annual intake of traditional Chinese medicine and the optimal distribution of pollution levels, three test methods—Kolmogorov-Smirnov, Anderson-Darling, and Chi-Squared—were used to test the fitted data.

6. The probability risk assessment method for ochratoxin A in traditional Chinese medicine according to claim 1, characterized in that, Between S04 and S05, there is also a risk threshold TR determination step, which specifically involves calculating the risk threshold TR based on different toxicity effect MOE thresholds (TMOE). Among them, BMDL 10 The lower limit of the baseline dose is 10%; TMOE is the threshold for toxic effects.

7. The probability risk assessment method for ochratoxin A in traditional Chinese medicine according to claim 6, characterized in that, The specific method for calculating the risk entropy RQ based on non-tumor effects and tumor effects in S05 is as follows: Where RQ is the risk entropy RQ; TR is the risk threshold; EDI is the daily exposure to non-tumor effects; and EDIcancer is the daily exposure to tumor effects.

8. A probability risk assessment system for ochratoxin A in traditional Chinese medicine, characterized in that, The system includes: The data acquisition module is used to obtain the annual intake (CS) of the target traditional Chinese medicine (TCM) of the consumer population. Y Ochratoxin A contamination level L t The transfer rate t of ochratoxin A during the decoction process; The optimal distribution fitting module is used to determine the annual intake CS of the traditional Chinese medicine. Y and the pollution level L t We performed distribution function fitting and obtained the optimal distribution of annual intake of traditional Chinese medicine and the optimal distribution of pollution level. The daily exposure calculation module is used to establish an exposure assessment model M, and calculate the daily exposure distribution of ochratoxin A in the Chinese medicine to be assessed under non-tumor and tumor effects based on the optimal distribution of annual intake of the Chinese medicine, the optimal distribution of pollution level, and the transfer rate t, combined with the exposure assessment model M. The risk entropy RQ calculation module is used to calculate and obtain the risk entropy RQ based on the daily exposure distribution. The risk assessment module is used to compare the risk entropy RQ with the safety standard value to assess the risk level of ochratoxin A in traditional Chinese medicine.

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