Heavy metal content detection method for preparation management

Abstract

The invention relates to the technical field of heavy metal content detection, in particular to a heavy metal content detection method for preparation management, which comprises the following steps of: setting a sampling time point, collecting samples in each stage of preparation production, conveying the samples to a sample treatment area, treating to obtain a detection sample, and performing turbidity detection, pH (Potential of Hydrogen) determination and oxidative degradation analysis to obtain the content of heavy metal in the preparation management. Calculating a display state evaluation coefficient of the detection sample, judging whether the detection sample is abnormal or not, if the detection sample is abnormal, analyzing and calculating actual concentration deviation values of various heavy metal ions, screening abnormal heavy metal ions, determining target heavy metal ions through continuous detection, and performing accurate content detection on the target heavy metal ions. According to the method, the content deviation level is calculated, the content adjustment parameters are generated, the production process parameters are optimized according to the content deviation level, dynamic adjustment is achieved, and therefore the precision, stability and controllability of heavy metal content detection are improved by combining a multi-dimensional detection means and a dynamic regulation and control mechanism.

Description

Technical Field

[0001] The present invention relates to the technical field of heavy metal content detection, and specifically to a heavy metal content detection method for preparation management. Background Art

[0002] During the preparation production process, heavy metal pollution is an important factor affecting product quality and safety. Heavy metal ions such as lead (Pb), cadmium (Cd), mercury (Hg), arsenic (As), etc. may come from raw materials, production environment, equipment or packaging materials. If their content exceeds the standard, it will not only affect the stability and efficacy of the preparation, but also may cause serious harm to human health. Therefore, how to accurately detect and dynamically control the heavy metal content in the preparation to ensure compliance with quality standards has become an important problem to be solved in the preparation production process; However, traditional heavy metal detection methods have problems such as inaccurate and incomplete detection, large single - detection error, and lack of dynamic adjustment mechanism. They usually rely on a single detection technology and fail to accurately analyze different heavy metal types, resulting in deviation of detection results and being difficult to meet the requirements of efficient and comprehensive detection. At the same time, affected by external environmental factors such as experimental environment, equipment error, and solvent composition, single - detection is difficult to truly reflect the heavy metal content level, prone to misjudgment or missed judgment. In addition, even if heavy metal exceeding the standard is found, it is still difficult to timely adjust process parameters for optimization during the production process, resulting in increased product scrap and rework rate, increased production costs, and being difficult to ensure the quality safety and efficiency of preparation production; To solve the above defects, a technical solution is provided now. Summary of the Invention

[0003] The purpose of the present invention is to solve the problems existing in traditional heavy metal detection methods, such as inaccurate and incomplete detection, large single - detection error, and lack of dynamic adjustment mechanism, and to propose a heavy metal content detection method for preparation management.

[0004] The purpose of the present invention can be achieved through the following technical solutions: A heavy metal content detection method for preparation management includes the following steps: Step 1: Set sampling time points to collect a set amount of samples at each stage of the preparation production process, obtain the samples at each stage of the preparation production process, and transport them to the sample processing area; Step 2: Perform processing operations on the samples in the sample processing area to obtain a processed sample solution as the detection sample; Step 3: Analyze the display state of the detection sample to obtain the display state evaluation coefficient of the detection sample, and accordingly determine whether the display state of the detection sample is an abnormal state, where: Determine the display status evaluation coefficient based on the turbidity detection value, pH detection value, and degradation amount detection value of the test sample; Step 4: If the display status of the test sample is determined to be an abnormal state, analyze the heavy metal status of the test sample to obtain the actual concentration deviation values of various heavy metal ions, and based on this, determine whether each heavy metal ion is an abnormal heavy metal ion. For the determined abnormal heavy metal ions, record an abnormality once; Continuously execute Steps 1 to 4, thereby obtaining the number of abnormalities of various heavy metal ions in a group of test samples, and based on this, obtain the target heavy metal ions; Step 5: Conduct precise detection and analysis on the content status of the target heavy metal ions to obtain the content deviation level of the target heavy metal ions, thereby determining the content adjustment parameters of the target heavy metal ions and generating an adjustment instruction for adjustment operations.

[0005] Further, the specific process of processing the samples in the sample processing area is as follows: Obtain the physical state of the samples in the sample processing area, and select the corresponding processing method according to the physical state of the samples in the sample processing area, thereby obtaining the preprocessed samples; Perform digestion processing on the preprocessed samples, specifically: decompose the samples by using a digestion method to release heavy metal ions, and obtain the processed sample solution as the test sample.

[0006] Further, the solving process of the turbidity detection value of the test sample is as follows: Collect the apparent image of the test sample, and arrange detection points on the apparent image of the test sample to obtain each detection point in the apparent image of the test sample. Extract the chromaticity values of each detection point in the apparent image of the test sample, and compare and analyze the chromaticity values of each detection point with a preset reference interval. If the chromaticity value of a certain detection point is outside the preset reference interval, then calibrate the certain detection point as an abnormal point, and integrate the abnormal points to obtain the abnormal area, which is used as the turbidity detection value of the test sample 。

[0007] Further, the solving process of the pH detection value of the test sample is as follows: Detect the pH value of the test sample to obtain the pH value of the test sample, and compare and analyze the pH value of the test sample with a preset reference comparison interval. If the pH value of the test sample is outside the preset reference comparison interval, then determine the pH value of the test sample as an abnormal state. At the same time, calculate the difference between the pH value of the test sample and the average value of the maximum and minimum values of the reference comparison interval to obtain the pH deviation value of the test sample, which is used as the pH detection value of the test sample 。

[0008] Further, the process for solving the degradation amount detection value of the test sample is as follows: Add an oxidation reagent to the test sample, and measure the generation amount of the oxidation degradation product at different detection time points. Set the first measured detection time point as the initial detection time point, and calculate the change value of the generation amount of the oxidation degradation product at each detection time point relative to the initial detection time point to obtain the generation amount difference of the oxidation degradation product at each detection time point. Take the average value of the generation amount differences of the oxidation degradation product at all detection time points to obtain the average generation amount difference of the oxidation degradation product, and use this as the degradation amount detection value of the test sample .

[0009] Further, the specific process for determining whether the display state of the test sample is an abnormal state is as follows: Extract the turbidity detection value of the test sample , pH detection value and degradation amount detection value of the numerical values for normalization processing, according to the formula: , to obtain the display state evaluation coefficient YBP of the test sample, where represents the set natural constant, respectively represent the set weight coefficients, and , the weight coefficient is used to balance the proportion weight of each item of data in the formula calculation, so as to promote the accuracy of the calculation result; Compare and analyze the display state evaluation coefficient of the test sample with the set display state evaluation threshold. If the display state evaluation coefficient of the test sample is greater than the set display state evaluation threshold, it is determined that the display state of the test sample is an abnormal state.

[0010] Further, the process for solving the actual concentration deviation value of various heavy metal ions is as follows: Through the detection and analysis of the test sample, obtain the concentration of various heavy metal ions in the test sample as the concentration value of various heavy metal ions in the test sample; Set a standard control group, specifically set as: select a standard sample equal in amount to the test sample, and perform digestion treatment to obtain the treated standard sample. Detect the standard sample and measure the concentration of various heavy metal ions in the standard sample as the standard concentration value of various heavy metal ions in the standard sample; Set a blank control group, specifically set as: select a blank matrix, and perform the same experimental process as the sample and the standard control group to measure the concentration of various heavy metal ions in the blank sample as the concentration value of various heavy metal ions in the blank sample; Obtain the actual concentration deviation value of various heavy metal ions according to the formula , where k represents the label of various heavy metal ions.

[0011] Further, the specific process of determining whether various heavy metal ions are abnormal heavy metal ions is as follows: Compare and analyze the actual concentration deviation values of various heavy metal ions with the preset actual concentration deviation thresholds. When the actual concentration deviation value of a certain type of heavy metal ion is greater than or equal to the preset actual concentration deviation threshold, then determine this type of heavy metal ion as an abnormal heavy metal ion.

[0012] Further, the solution process for the target heavy metal ions is as follows: Compare and analyze the abnormal times of various heavy metal ions in a group of detection samples with the preset reference abnormal time interval. When the abnormal times of various heavy metal ions in a group of detection samples are within the preset reference abnormal time interval, then determine this type of heavy metal ion as the target heavy metal ion.

[0013] Further, the specific process of determining the content adjustment parameter of the target heavy metal ion is as follows: Match the corresponding heavy metal content detection method according to the type of the target heavy metal ion, thereby obtaining the content of the target heavy metal ion, and calculate the difference between the content of the target heavy metal ion and the preset content threshold to obtain the content deviation value of the target heavy metal ion; Match and analyze the content deviation value of the target heavy metal ion with the content deviation status table stored in the system, thereby obtaining the content deviation level of the target heavy metal ion, and at the same time match it with the heavy metal ion content adjustment parameter corresponding to the content deviation level, thereby obtaining the content adjustment parameter of the target heavy metal ion.

[0014] The technical solution provided by the present invention has the following beneficial effects compared with the known prior art: 1. In the present invention, through standardized sample collection and processing, according to the set sampling time points, different sampling methods (rotary sampling, homogenization sampling, multi-point sampling) in different states are adopted to ensure data representativeness. At the same time, the sample processing is optimized through methods such as grinding, filtering, and digestion, thereby ensuring the representativeness, consistency, and reliability of the detection samples and providing accurate data support for subsequent heavy metal detection; 2. In the present invention, through multi-dimensional detection technology combined with apparent image analysis, pH value measurement, and oxidative degradation analysis, the abnormal state of the detection samples is accurately judged, thereby realizing multi-dimensional detection of the detection samples to accurately identify heavy metal pollution and effectively reducing the misjudgment rate that may be caused by a single detection method; 3. In the present invention, through heavy metal ion concentration detection, setting of standard control groups and blank control groups, and actual concentration deviation calculation, the accurate analysis of the abnormal state of heavy metal ions in the detection samples is realized, ensuring the scientificity, stability, and accuracy of the detection results; 4. In the present invention, through the abnormal frequency determination mechanism, according to the continuous detection process, the abnormal frequencies of various heavy metal ions are counted to ensure that the determination basis is derived from multiple data points, thereby effectively improving the stability of detection, avoiding misjudgment caused by short-term fluctuations or accidental errors, and improving the screening accuracy. 5. In the present invention, by matching the detection method of heavy metal ion content, calculating the content deviation level, thereby matching the corresponding adjustment parameters of heavy metal ion content and generating an adjustment instruction to adjust the production process parameters, the dynamic optimization control of heavy metal content is realized. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present invention, and those of ordinary skill in the art can obtain other drawings according to these drawings without creative efforts.

[0016] Figure 1 It is a block diagram of the overall method flow of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0017] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the following will clearly and completely describe the technical solutions in the embodiments of the present invention with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.

[0018] As Figure 1 shown, a method for detecting heavy metal content for preparation management includes: Step 1. Sample collection: Samples are collected at each stage of the preparation production process. The specific collection process is as follows: Samples of a set amount are collected at each stage of the preparation production process (including raw materials, semi-finished products, and finished products) by setting sampling time points, and samples at each stage of the preparation production process are obtained. At the same time, samples at each stage of the preparation production process are transported to the sample processing area; Among them, the method of sample collection is: If the sample state is solid, the rotary sampling method is used for sampling. Specifically, a non-polluting sampler is rotated to different positions (such as the top, middle, and bottom) for separate sampling, and the collected samples are combined; If the sample is in a liquid state, sampling is carried out after homogenization and stirring. Specifically: use a stirrer to homogenize and mix the liquid, and then use a non-polluting sampler to sample at different depths (surface layer, middle layer, bottom layer) respectively, and combine the collected samples; If the sample is in a powder state, multi-point sampling is adopted. Specifically: use a non-polluting sampler to adopt the cross sampling method or the grid sampling method to sample at different parts (surface layer, middle layer, bottom layer) respectively, and combine the collected samples; It should be noted that the non-polluting sampler includes but is not limited to sampling spoons, pipettes, glass straws, powder samplers, etc.; In a specific embodiment, since there may be heavy metals with different concentrations at different stages (raw materials, semi-finished products, finished products) during the preparation production process, in order to ensure the accuracy of the detection results, this method quantitatively and standardly samples each stage of the preparation production process through the set sampling time points, ensuring the representativeness, consistency and reliability of the detection samples, and providing accurate data support for subsequent heavy metal detection.

[0019] Step two: Sample treatment: Perform treatment operations on the samples in the sample treatment area. The specific operation process is as follows: By obtaining the physical state of the samples in the sample treatment area, select the corresponding treatment method according to the physical state (solid, liquid, powder) of the samples in the sample treatment area, thereby obtaining the pre-treated samples to ensure sample homogenization and reduce external interference; If the physical state is solid, the grinding and pulverization method is adopted to grind the sample to a uniform state to improve the solubility and detection accuracy of the sample; If the physical state is liquid, remove impurities by filtration to ensure that the detection process is not interfered by particulate matter; If the physical state is powder, it is already in a uniform state and does not require further treatment; Perform digestion treatment on the pre-treated samples. Specifically: decompose the samples by adopting digestion methods (such as acid digestion method, microwave digestion method) to release heavy metal ions, and obtain the treated sample solution as the detection sample; In a specific embodiment, the present invention realizes ensuring the accuracy, stability and repeatability of heavy metal content detection by optimizing sample treatment, and provides high-quality sample data support for subsequent heavy metal content analysis and control.

[0020] Step three: Preliminary determination of the detection sample: Analyze the display state of the detection sample. The specific analysis process is as follows: Collect the apparent image of the test sample through a high-definition camera to obtain the apparent image of the test sample, and arrange detection points on the apparent image of the test sample to obtain each detection point in the apparent image of the test sample. Extract the chromaticity values of each detection point in the apparent image of the test sample, and compare and analyze the chromaticity values of each detection point in the apparent image of the test sample with a preset reference interval. If the chromaticity value of a certain detection point in the apparent image of the test sample is outside the preset reference interval, then label a certain detection point in the apparent image of the test sample as an abnormal point; otherwise, label a certain detection point in the apparent image of the test sample as a normal point. Integrate and process the abnormal points in the apparent image of the test sample to obtain the abnormal area in the apparent image of the test sample, which is used as the turbidity detection value of the test sample and marked as ; Detect the pH value of the test sample through a high-precision pH meter to obtain the pH value of the test sample, and compare and analyze the pH value of the test sample with a preset reference comparison interval. If the pH value of the test sample is outside the preset reference comparison interval, then determine the abnormal state of the pH value of the test sample. At the same time, calculate the difference between the pH value of the test sample and the average value of the maximum and minimum values of the reference comparison interval to obtain the pH deviation value of the test sample, which is used as the pH detection value of the test sample and marked as ; Add an oxidation reagent to the test sample, and measure the generation amount of the oxidation degradation product at different detection time points. Set the first measured detection time point as the initial detection time point, and calculate the change value of the generation amount of the oxidation degradation product at each detection time point relative to the initial detection time point to obtain the generation amount difference of the oxidation degradation product at each detection time point. Take the average value of the generation amount differences of the oxidation degradation product at all detection time points to obtain the average generation amount difference of the oxidation degradation product, which is used as the degradation amount detection value of the test sample and marked as ; Extract the turbidity detection value of the test sample 、pH detection value and degradation amount detection value Perform normalization processing on the numerical values, according to the formula: , to obtain the display state evaluation coefficient YBP of the test sample, where represents the set natural constant, respectively represent the set weight coefficients, and , the weight coefficients are used to balance the proportion weights of each item of data in the formula calculation, so as to promote the accuracy of the calculation result; Compare and analyze the display status evaluation coefficient YBP of the test sample with the set display status evaluation threshold YBY. If the display status evaluation coefficient YBP of the test sample is less than or equal to the set display status evaluation threshold YBY, it is determined that the display status of the test sample is normal. If the display status evaluation coefficient YBP of the test sample is greater than the set display status evaluation threshold YBY, it is determined that the display status of the test sample is abnormal; In a specific embodiment, the present invention realizes multi-dimensional detection of the test sample by combining image detection, pH value measurement, and oxidative degradation analysis to accurately identify heavy metal pollution and reduce the misjudgment rate. Specifically: Use a high-definition camera to obtain the apparent image of the sample, analyze the change in chromaticity value through the detection point layout, calculate the turbidity detection value, and accurately identify the color abnormality caused by heavy metal pollution. Use a high-precision pH meter to detect the change in the pH value of the sample, obtain the pH detection value, and judge whether there is an abnormal pH caused by heavy metal ions. Through the degradation reaction of the oxidation reagent, measure the generation amount of the oxidation degradation product, and calculate the degradation amount detection value to indirectly evaluate the impact of heavy metals on the stability of the preparation, thereby making a preliminary judgment on the test sample, ensuring the accuracy of the evaluation result, and effectively reducing the misjudgment rate caused by a single detection method.

[0021] Step Four: Initial Detection: If the display status of the test sample is determined to be abnormal, analyze the heavy metal status of the test sample. The specific analysis process is as follows: Use a heavy metal concentration detector to detect and analyze the test sample to obtain the concentration of various heavy metal ions in the test sample, which is used as the concentration value of various heavy metal ions in the test sample and is marked as ; Set a standard control group. The specific setting is as follows: Select a standard sample equal in amount to the test sample and perform digestion treatment (such as acid digestion, microwave digestion) to ensure that the heavy metal ions in the standard sample are fully released, obtaining the treated standard sample. Use a heavy metal detector to detect the standard sample and measure the concentration of various heavy metal ions in the standard sample, which is used as the standard concentration value of various heavy metal ions in the standard sample and is marked as ; Set a blank control group. The specific setting is as follows: Select a blank matrix (such as deionized water or a solvent without heavy metal pollution), and perform treatment according to the same experimental process as the sample and the standard control group. Use a heavy metal detector to measure the concentration of various heavy metal ions in the blank sample, which is used as the concentration value of various heavy metal ions in the blank sample and is marked as ; According to the formula: , obtain the actual concentration deviation value of various heavy metal ions , where k represents the label of various heavy metal ions; Compare and analyze the actual concentration deviation values of various heavy metal ions with the preset actual concentration deviation thresholds. When the actual concentration deviation value of a certain type of heavy metal ion is greater than or equal to the preset actual concentration deviation threshold, then determine this type of heavy metal ion as an abnormal heavy metal ion and record an abnormality for this type of heavy metal ion. Conversely, when the actual concentration deviation value of a certain type of heavy metal ion is less than the preset actual concentration deviation threshold, then determine this type of heavy metal ion as a normal heavy metal ion; By continuously executing steps one to four, the number of abnormalities of various heavy metal ions in a set of test samples is obtained. Compare and analyze the number of abnormalities of various heavy metal ions in a set of test samples with the preset reference abnormality number range. When the number of abnormalities of various heavy metal ions in a set of test samples is within the preset reference abnormality number range, then determine this type of heavy metal ion as the target heavy metal ion. Conversely, do not make a determination; In a specific embodiment, the present invention realizes the precise analysis of the abnormal state of heavy metal ions in test samples through heavy metal ion concentration detection, setting of standard control groups and blank control groups, concentration deviation calculation, and abnormality number determination, ensuring the scientificity, stability, and accuracy of the detection. In the actual detection process, the heavy metal ion concentration of test samples may be affected by factors such as solvent components, experimental conditions, and equipment errors. Single - test data is difficult to fully reflect the real situation. Therefore, this method constructs reference data through standard control groups and blank control groups and calculates the actual concentration deviation value, making the detection results more scientific and reasonable. Additionally, considering that environmental fluctuations may cause single - measurement errors, continuously execute the detection process and count the number of abnormalities to ensure that the judgment basis comes from multiple data points, effectively improving the stability of the detection, reducing misjudgments or missed judgments caused by accidental errors, and not relying solely on single - concentration abnormalities for judgment, ensuring that the finally selected target heavy metal ions truly have an over - standard risk rather than being short - term fluctuations or accidents, thereby greatly improving the accuracy of the screening.

[0022] Step Five: Precise Detection: Conduct precise detection and analysis on the content state of the target heavy metal ion. The specific detection and analysis process is as follows: Match the corresponding heavy metal content detection method according to the type of the target heavy metal ion, thereby obtaining the content of the target heavy metal ion, and calculate the difference between the content of the target heavy metal ion and the preset content threshold to obtain the content deviation value of the target heavy metal ion; Match and analyze the content deviation value of the target heavy metal ion with the content deviation status table stored in the system, so as to obtain the content deviation level of the target heavy metal ion. Each content deviation value of the target heavy metal ion corresponds to a content deviation level. At the same time, match it with the heavy metal ion content adjustment parameter corresponding to the content deviation level, so as to obtain the target heavy metal ion content adjustment parameter, and generate an adjustment instruction. According to the adjustment instruction, adjust and control the production process parameters to dynamically adjust the content of the target heavy metal ion to meet the quality standards of pharmaceutical preparation production; It should be noted that the heavy metal content detection methods include, but are not limited to, graphite furnace atomic absorption spectrometry, cold atomic absorption spectrometry, atomic fluorescence spectrometry, etc.; The production process parameters include, but are not limited to, optimization of raw material components, regulation of process conditions, purification and separation, etc.; In a specific embodiment, the present invention accurately detects the content status of the target heavy metal ion and combines with a dynamic adjustment mechanism to ensure the stable control of the heavy metal content in the pharmaceutical preparation production process and improve the safety and compliance of the product quality.

[0023] The preferred embodiments of the present invention disclosed above are only used to help explain the present invention. The preferred embodiments do not describe all the details in detail, nor do they limit the present invention to the specific embodiments. Obviously, many modifications and variations can be made according to the content of this specification. These embodiments are selected and specifically described in this specification to better explain the principle and practical application of the present invention, so that those skilled in the art can understand and utilize the present invention well. The present invention is only limited by the claims and their full scope and equivalents.

Claims

1. A method for detecting heavy metal content in preparation management, characterized in that, It includes the following steps: Step 1: Set sampling time points to collect a set amount of samples at each stage of the preparation production process, obtain the samples at each stage in the preparation production process, and transport them to the sample processing area; Step 2: Perform processing operations on the samples in the sample processing area to obtain a processed sample solution as the test sample; Step 3: Analyze the display state of the test sample to obtain a display state evaluation coefficient of the test sample, and accordingly determine whether the display state of the test sample is an abnormal state, where: Determine the display state evaluation coefficient based on the turbidity detection value, pH detection value, and degradation amount detection value of the test sample; Step 4: If the display state of the test sample is determined to be an abnormal state, analyze the heavy metal state of the test sample to obtain the actual concentration deviation value of various heavy metal ions, and accordingly determine whether various heavy metal ions are abnormal heavy metal ions, and record one abnormality for the determined abnormal heavy metal ions; Continuously execute Steps 1 to 4 to obtain the number of abnormalities of various heavy metal ions in a set of test samples, and accordingly obtain the target heavy metal ions; Step 5: Accurately detect and analyze the content state of the target heavy metal ions to obtain the content deviation level of the target heavy metal ions, thereby determining the content adjustment parameter of the target heavy metal ions and generating an adjustment instruction for adjustment operations.

2. The heavy metal content detection method for preparation management according to claim 1, wherein, The specific process of performing processing operations on the samples in the sample processing area is as follows: Obtain the physical state of the samples in the sample processing area, select the corresponding processing method according to the physical state of the samples in the sample processing area, and thus obtain the preprocessed samples; Perform digestion processing on the preprocessed samples, specifically: decompose the samples by using a digestion method to release heavy metal ions, and obtain a processed sample solution as the test sample.

3. The heavy metal content detection method for preparation management according to claim 1, characterized in that, The solution process of the turbidity detection value of the test sample is as follows: By collecting the apparent image of the test sample, arranging detection points on the apparent image of the test sample to obtain each detection point in the apparent image of the test sample, extracting the chromaticity values of each detection point in the apparent image of the test sample, comparing and analyzing the chromaticity values of each detection point with a preset reference interval, if the chromaticity value of a certain detection point is outside the preset reference interval, then the certain detection point is calibrated as an abnormal point, and the abnormal points are integrated to obtain an abnormal area, which is used as the turbidity detection value of the test sample .

4. A heavy metal content detection method for preparation management according to claim 1, characterized in that, The solution process of the pH detection value of the test sample is as follows: By detecting the pH value of the test sample, the pH value of the test sample is obtained, and the pH value of the test sample is compared and analyzed with a preset reference comparison interval. If the pH value of the test sample is outside the preset reference comparison interval, the pH value of the test sample is determined to be in an abnormal state. At the same time, the difference between the pH value of the test sample and the average value of the maximum and minimum values of the reference comparison interval is calculated to obtain the pH deviation value of the test sample, which is used as the pH detection value of the test sample .

5. A heavy metal content detection method for preparation management according to claim 1, characterized in that, The solution process of the degradation amount detection value of the test sample is as follows: An oxidation reagent is added to the test sample, and the amount of the oxidation degradation product generated is measured at different test time points. The first measured test time point is set as the initial test time point, and the change value of the amount of the oxidation degradation product generated at each test time point relative to the initial test time point is calculated to obtain the difference in the amount of the oxidation degradation product generated at each test time point. The mean value of the differences in the amount of the oxidation degradation product generated at all test time points is taken to obtain the average difference in the amount of the oxidation degradation product generated, which is used as the degradation amount detection value of the test sample 。 6. The heavy metal content detection method for preparation management according to claim 1, characterized in that The specific process of determining whether the display state of the test sample is an abnormal state is as follows: Extract the turbidity detection value of the test sample , pH detection value and degradation amount detection value Normalize the values, according to the formula: , to obtain the display state evaluation coefficient YBP of the test sample, where represents the set natural constant, respectively represent the set weight coefficients, and , the weight coefficients are used to balance the proportion weights of each item of data in the formula calculation, so as to promote the accuracy of the calculation result; Compare and analyze the display state evaluation coefficient of the test sample with the set display state evaluation threshold. If the display state evaluation coefficient of the test sample is greater than the set display state evaluation threshold, then determine that the display state of the test sample is an abnormal state.

7. A heavy metal content detection method for preparation management according to claim 1, characterized in that The solution process of the actual concentration deviation value of various heavy metal ions is as follows: By detecting and analyzing the test sample, the concentrations of various heavy metal ions in the test sample are obtained as the concentration values of various heavy metal ions in the test sample ; Set up a standard control group, specifically as follows: Select a standard sample equal in amount to the test sample, and perform digestion treatment to obtain the treated standard sample. Test the standard sample to determine the concentrations of various heavy metal ions in the standard sample, which are used as the standard concentration values of various heavy metal ions in the standard sample ; A blank control group was set up, specifically as follows: A blank matrix was selected and processed according to the same experimental procedures as the sample and standard control groups, and the concentrations of various heavy metal ions in the blank samples were measured as the concentration values of various heavy metal ions in the blank samples. ; According to the formula: , the actual concentration deviation values of various heavy metal ions are obtained , where k represents the label of various heavy metal ions.

8. A heavy metal content detection method for preparation management according to claim 1, characterized in that, The specific process of determining whether various heavy metal ions are abnormal heavy metal ions is as follows: Compare and analyze the actual concentration deviation value of various heavy metal ions with the preset actual concentration deviation threshold. When the actual concentration deviation value of a certain type of heavy metal ion is greater than or equal to the preset actual concentration deviation threshold, then determine that this type of heavy metal ion is an abnormal heavy metal ion.

9. A heavy metal content detection method for preparation management according to claim 1, characterized in that, The solution process of the target heavy metal ions is as follows: Compare and analyze the number of abnormalities of various heavy metal ions in a set of test samples with the preset reference abnormality number interval. When the number of abnormalities of various heavy metal ions in a set of test samples is within the preset reference abnormality number interval, then determine that this type of heavy metal ion is the target heavy metal ion.

10. The heavy metal content detection method for preparation management according to claim 1, characterized in that, The specific process of determining the content adjustment parameter of the target heavy metal ions is as follows: Match the corresponding heavy metal content detection method according to the type of target heavy metal ions, thereby obtaining the content of the target heavy metal ions, and calculate the difference between the content of the target heavy metal ions and the preset content threshold value to obtain the content deviation value of the target heavy metal ions; Match and analyze the content deviation value of the target heavy metal ions with the content deviation status table stored in the system, thereby obtaining the content deviation level of the target heavy metal ions, and at the same time match it with the heavy metal ion content adjustment parameter corresponding to the content deviation level, thereby obtaining the target heavy metal ion content adjustment parameter.

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