An intelligent monitoring and control system for pharmaceutical intermediate synthesis production line

Abstract

This invention belongs to the field of pharmaceutical intermediate production quality optimization. Specifically, it discloses an intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line. This system includes four analytical measures: deviations in the accuracy of operational parameters, unreasonable parameter settings, deviations in raw material input ratios, and unreasonable raw material fusion sequences. These measures determine the causes of insufficient purity in pharmaceutical intermediate production, thereby quickly locating the problem and shortening the troubleshooting cycle. When the insufficient purity of the synthesized pharmaceutical intermediate is related to deviations in the accuracy of operational parameters, analyzing the reasonable setting of equipment operating parameters for processes containing unexpected components helps provide optimization suggestions for equipment operation parameter settings, thereby improving overall production purity and quality. Furthermore, by conducting experiments on combinations of raw materials corresponding to processes containing unexpected components according to their input sequences, a more efficient fusion sequence can be obtained, thereby improving the synthesis efficiency of the product.

Description

Technical Field

[0001] The invention belongs to the field of pharmaceutical intermediate production quality optimization and relates to an intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line. Background Art

[0002] In today's pharmaceutical intermediates manufacturing field, with the rapid growth of market demand and the continuous improvement of product quality standards, the limitations of traditional production processes and technologies have become increasingly prominent, seriously hindering the improvement of production efficiency and the optimization of product purity, especially in ensuring the purity control of pharmaceutical intermediates. Therefore, a comprehensive and intelligent monitoring system is urgently needed, which needs to be able to deeply understand every link of pharmaceutical intermediate production in order to achieve a deep understanding of the production process.

[0003] Existing technologies have achieved some solutions to solve the purity control in the production process of pharmaceutical intermediates, but there are still some obvious shortcomings: 1. When analyzing the reasons for insufficient purity, they often only focus on a single factor, such as raw material quality or equipment performance, and ignore the complex interactions between multiple factors, resulting in inaccurate problem location and difficulty in taking corrective measures quickly and effectively.

[0004] 2. Often, the operational error points of the production line implementation steps are determined based on the set values, without considering the rationality of the set values.

[0005] 3. The fusion order of raw materials mainly depends on fixed conditions. There are deficiencies in exploring efficient fusion order for raw material fusion operations, which limits the room for improving synthesis efficiency. Summary of the invention

[0006] In view of this, in order to solve the problems raised in the above background technology, an intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line is proposed.

[0007] The purpose of the present invention can be achieved through the following technical solutions: The present invention provides an intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line, including: a production line synthesis data extraction module, used to obtain a preset pharmaceutical intermediate synthesis process route, including each synthesis process corresponding to each action parameter, and each synthesis process corresponding to each raw material.

[0008] The synthesis product purity analysis module is used to extract the total amount of pharmaceutical intermediate synthesis product components, various product components and their contents in each synthesis process, determine the purity of pharmaceutical intermediate synthesis products, and locate unexpected components in the audit process when the purity is insufficient.

[0009] The action parameter operation accuracy judgment module is used to extract the actual control value of each action parameter corresponding to each synthesis process, and determine whether the reason for the insufficient purity of the pharmaceutical intermediate synthesis product is related to the deviation of the action parameter control accuracy.

[0010] The parameter rationality judgment module is set to extract the identification parameters of the review process when the reason for the insufficient purity of the pharmaceutical intermediate synthesis product is related to the deviation of the action parameter control accuracy, and to judge whether the identification parameter settings of the review process are reasonable.

[0011] The module for judging the rationality of the release ratio is used to extract the raw material fusion ratio records corresponding to the audit process and judge its operational compliance status when the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is not related to the deviation of the action parameter control accuracy.

[0012] The fusion product analysis module for drug sequence change is used to conduct change tests on the raw material delivery sequence combination, record the raw material fusion operation information corresponding to the review process, and evaluate the conflict coefficient of the fusion operation product of the raw materials belonging to the review process under each delivery sequence combination.

[0013] The raw material implementation sequence control module is used to evaluate the severity of the raw material reaction conditions in the review process, and then control the raw material fusion sequence in the review process.

[0014] Compared with the prior art, the beneficial effects of the present invention are as follows: (1) The present invention periodically detects the purity of pharmaceutical intermediates. When the purity of the synthesized product is insufficient, the present invention determines the cause of insufficient purity of the pharmaceutical intermediate production based on four analysis measures, namely, deviation in the operation accuracy of action parameters, unreasonable setting parameters, deviation in the proportion of raw materials, and unreasonable raw material fusion sequence, thereby quickly locating the problem and shortening the fault resolution cycle.

[0015] (2) The present invention locates the unexpected components that lead to insufficient purity of pharmaceutical intermediates and the process in which they are located, identifies the correlation between the unexpected components and the operating accuracy of the equipment in the process, and determines whether the abnormal operation of the process equipment is the cause of insufficient purity of the pharmaceutical intermediate production, provides targeted guidance for equipment maintenance and accuracy calibration, and prevents similar problems from occurring in the future.

[0016] (3) When the reason for insufficient purity of the synthetic product of the pharmaceutical intermediate is related to the deviation of the precision of the action parameter control, the present invention analyzes the reasonable state of the equipment operation parameter setting of the process where the unexpected component is located, which helps to provide optimization suggestions for the setting of the equipment action parameters, thereby improving the overall production purity quality. At the same time, when the reason for insufficient purity of the synthetic product of the pharmaceutical intermediate is not related to the deviation of the precision of the action parameter control, by identifying the compliance of the fusion operation of the raw materials, it is confirmed whether the raw materials meet the production requirements, avoiding purity problems caused by unqualified raw material quality.

[0017] (4) The present invention conducts experiments by combining the raw materials corresponding to the process where the unexpected components are located in various order of addition, and combines the volatility index, processing complexity, and standing time of each raw material to obtain a more efficient fusion order, thereby improving the synthesis efficiency of the product. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings required for describing the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other accompanying drawings can be obtained based on these accompanying drawings without paying creative work.

[0019] Figure 1 It is a schematic diagram of the connection of the system modules of the present invention. DETAILED DESCRIPTION

[0020] 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.

[0021] See also Figure 1 As shown, the present invention provides an intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line, the system comprising: a production line synthesis data extraction module, a synthesis product purity analysis module, an action parameter operation accuracy judgment module, a setting parameter rationality judgment module, a release ratio rationality judgment module, a drug sequence change fusion product analysis module, a raw material implementation sequence control module, and a production line execution data storage library.

[0022] The production line synthesis data extraction module is connected to the synthesis product purity analysis module, the synthesis product purity analysis module is connected to the action parameter operation precision judgment module, the action parameter operation precision judgment module is respectively connected to the setting parameter rationality judgment module and the delivery ratio rationality judgment module, the delivery ratio rationality judgment module is connected to the drug sequence change fusion product analysis module, the drug sequence change fusion product analysis module is connected to the raw material implementation sequence control module, and the production line execution data storage library is respectively connected to the synthesis product purity analysis module, the action parameter operation precision judgment module, the setting parameter rationality judgment module, the delivery ratio rationality judgment module, and the raw material implementation sequence control module.

[0023] The production line synthesis data extraction module is used to obtain the preset pharmaceutical intermediate synthesis process route, including each synthesis process corresponding to each action parameter, each synthesis process corresponding to each raw material, and each action parameter includes reaction temperature, pressure, equipment stirring rate, reaction time, etc.

[0024] The synthetic product purity analysis module is used to extract the total amount of pharmaceutical intermediate synthetic product components, various product components of each synthetic process and their contents from the production line execution data storage library, determine the purity of the pharmaceutical intermediate synthetic product, and compare it with the preset synthetic product purity threshold. When it is less than the preset synthetic product purity threshold, it indicates that the purity of the pharmaceutical intermediate synthetic product is insufficient, and the unexpected components of the audit process are located.

[0025] In a specific embodiment of the present invention, the purity of the pharmaceutical intermediate synthesis product is determined by: extracting the component content of the target product and by-products in the pharmaceutical intermediate synthesis product from the production line execution data repository, comparing it with the total amount of the pharmaceutical intermediate synthesis product components, and obtaining the target product generation compliance degree and by-product generation regularity of the pharmaceutical intermediate synthesis product.

[0026] Through this step, two key indicators can be obtained: the degree of target product generation and the regularity of by-product generation.

[0027] Based on the above two indicators, the purity of the synthetic products of pharmaceutical intermediates can be comprehensively evaluated: if the target product generation degree is higher than the preset standard requirement value and the by-product generation regularity is lower than the preset regularity acceptance value, it means that the purity of the synthetic product is high and meets the quality standards.

[0028] The target product generation standard degree reflects the comparison result between the actual generation content of the target product and the expected or theoretical generation content in the synthesis process. The by-product generation regularity measures the regularity or acceptability of the by-product generation.

[0029] In a preferred embodiment, the method of locating the unexpected components of the audit process is specifically: comparing the various product components and their contents of each synthesis process with the various conventional product components preset in each synthesis process. When a certain product component of a synthesis process does not match the various conventional product components preset in the corresponding preset synthesis process, the product component of the synthesis process is marked as an unexpected component of the audit process.

[0030] The unexpected components of the review process include the following non-compliance situations: b1. When a certain product component of a synthesis process does not match the various conventional product components preset in the corresponding synthesis process, the product component of the synthesis process shall be recorded as an unexpected component of the review process.

[0031] b2. When a product component of a certain synthesis process matches the corresponding conventional product component preset in the corresponding synthesis process but the content does not match, extract the category attribute of the product component, which includes target product and by-product. When the category attribute of the product component is the target product, if the corresponding content of the product component of the synthesis process is less than the corresponding conventional product component content preset in the corresponding synthesis process, then record the product component of the synthesis process as an unexpected component of the review process.

[0032] b3. When the product category attribute is a by-product, if the corresponding content of the product component of the synthesis process is greater than the corresponding conventional product component content preset in the corresponding synthesis process, the product component of the synthesis process shall be recorded as an unexpected component of the review process.

[0033] The action parameter operation accuracy judgment module is used to extract the actual control value of each action parameter corresponding to each synthesis process from the production line execution data storage library, and determine whether the reason for the insufficient purity of the pharmaceutical intermediate synthesis product is related to the action parameter control accuracy deviation based on the preset value of each action parameter corresponding to each synthesis process.

[0034] In a specific embodiment of the present invention, the determination of whether the cause of insufficient purity of the pharmaceutical intermediate synthesis product is related to the deviation in the control accuracy of the action parameters is as follows: the actual control value of each action parameter corresponding to each synthesis process is compared with the preset value of the action parameter corresponding to the corresponding synthesis process to obtain the operation deviation value of each action parameter corresponding to each synthesis process.

[0035] If the operational deviation values ​​of the action parameters corresponding to each synthesis process are within the preset upper and lower limits of the reaction safety, it is determined that the cause of the insufficient purity of the synthetic product of the pharmaceutical intermediate is not related to the deviation in the control accuracy of the action parameters.

[0036] If the operational deviation value of a certain action parameter corresponding to a certain synthesis process is not within the preset upper and lower limits of the reaction safety, the action parameter corresponding to the synthesis process shall be recorded as the identification parameter of the verification process.

[0037] The verification process is compared with the audit process. If they match, it is determined that the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is related to the deviation in the precision of action parameter control, and the identification parameters of the verification process are the identification parameters of the audit process. If they do not match, it is determined that the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is not related to the deviation in the precision of action parameter control, and then the identification parameters of the verification process are corrected and fed back.

[0038] The present invention locates the unexpected components that lead to insufficient purity of pharmaceutical intermediates and the process in which they are located, identifies the correlation between the unexpected components and the operating accuracy of the equipment in the process, and determines whether abnormal operation of the process equipment is the cause of insufficient purity in the production of pharmaceutical intermediates. It provides targeted guidance for equipment maintenance and accuracy calibration, and prevents similar problems from occurring in the future.

[0039] The parameter setting rationality judgment module is used to extract the identification parameters of the audit process and judge whether the setting of the identification parameters of the audit process is reasonable when the reason for the insufficient purity of the pharmaceutical intermediate synthesis product is related to the deviation of the action parameter control accuracy.

[0040] In a specific embodiment of the present invention, the determination of whether the setting of the identification parameters of the audit process is reasonable includes: extracting the recent correction records of the control equipment to which the identification parameters of the audit process belong from the production line execution data repository; if the control equipment to which the identification parameters of the audit process belong has a corrected record, it is determined that the setting of the identification parameters of the audit process is unreasonable, and then an early warning feedback is given for the unreasonable setting.

[0041] Otherwise, deviation correction feedback will be given to the identification parameters of the audit process.

[0042] Specifically, when the control equipment to which the identification parameters of the audit process belong has a corrected record in the recent correction record, it means that the cause of the data deviation of the identification parameters of the audit process is not caused by the failure of the control equipment, and therefore the cause of the data deviation of the identification parameters of the audit process is attributed to unreasonable setting; when the control equipment to which the identification parameters of the audit process belong does not have a corrected record in the recent correction record, it means that the control equipment to which the identification parameters of the audit process belong may have a failure or misoperation, and then deviation correction feedback is given to it.

[0043] The module for judging the rationality of the release ratio is used to extract the raw material fusion ratio records corresponding to the audit process from the production line execution data storage library when the reason for the insufficient purity of the pharmaceutical intermediate synthesis product is not related to the deviation of the action parameter control accuracy, and to judge its operation compliance status.

[0044] In a specific embodiment of the present invention, the specific content of extracting the raw material fusion ratio records corresponding to the audit process and judging its operational compliance status includes: extracting the various requirement conditions corresponding to the preset raw material fusion ratio operation of the audit process, and comparing them with the corresponding requirement conditions in the raw material fusion ratio record corresponding to the audit process, each requirement condition includes the added type and dosage ratio of the raw materials, if a requirement condition in the raw material fusion ratio record corresponding to the audit process deviates from the preset corresponding requirement condition, then the operational compliance status of the raw material fusion ratio record corresponding to the audit process is recorded as non-compliant; if each requirement condition in the raw material fusion ratio record corresponding to the audit process is consistent with the preset corresponding requirement condition, then the operational compliance status of the raw material fusion ratio record corresponding to the audit process is recorded as compliant.

[0045] When the operational compliance status is operational compliance, it is determined that the reason for the insufficient purity of the pharmaceutical intermediate synthesis product is not related to the non-compliant raw material fusion ratio.

[0046] When the operation compliance status is non-compliant operation, extract the requirement conditions with deviations, and extract the expected product components corresponding to the requirement conditions under the deviation status, and compare them with the unexpected components of the audited process. If they match, it is determined that the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is related to the non-compliant fusion ratio of the raw materials; if they do not match, it is determined that the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is not related to the non-compliant fusion ratio of the raw materials.

[0047] Specifically, the expected product components corresponding to the various required conditions under the deviation state are pre-stored test data.

[0048] The present invention analyzes the reasonable state of the equipment operation parameter setting of the process where the unexpected component is located when the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is related to the deviation of the precision of the action parameter control, which helps to provide optimization suggestions for the setting of the equipment action parameters, thereby improving the overall production purity quality. At the same time, when the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is not related to the deviation of the precision of the action parameter control, by identifying the compliance of the fusion operation of the raw materials, it is confirmed whether the raw materials meet the production requirements, and the purity problem caused by the unqualified quality of the raw materials is avoided.

[0049] The fusion product analysis module for drug sequence change is used to conduct a change test on the raw material placement sequence combination when the reason for insufficient purity of the pharmaceutical intermediate synthesis product is not related to the non-compliant raw material fusion ratio. During the test, the raw material fusion operation information corresponding to the audit process is recorded, and the contradiction coefficient of the fusion operation product of the raw materials belonging to the audit process under each placement sequence combination is evaluated.

[0050] In a specific embodiment of the present invention, the evaluation of the contradiction coefficient of the fusion operation product of the raw materials belonging to the audit process under each combination of delivery order is as follows: the product change information of the raw materials belonging to the audit process under each combination of delivery order is obtained from the raw material fusion operation information, and the product change information includes the increase or decrease of the target product, the increase or decrease of the by-product, and the increase or decrease of the abnormal component, which are respectively recorded as M′ a , M″ a 、M a , evaluate the contradiction coefficient of the fusion operation products of the raw materials belonging to the audit process under each combination of delivery sequence a is the number of the combination of release sequence, a=1, 2, ..., c. The product contradiction coefficient of the fusion operation reveals the degree of influence of different raw materials on the product quality (including the component content of the target product and by-products) under a specific fusion sequence.

[0051] The raw material implementation sequence control module is used to evaluate the severity of the raw material reaction conditions in the review process, and then control the raw material fusion sequence in the review process.

[0052] In a specific embodiment of the present invention, the content of evaluating the severity of the raw material reaction conditions of the audit process includes: extracting the control range ε ​​of each action parameter of the audit process under each combination of delivery order from the raw material fusion operation information corresponding to the audit process ja , the change range of sub-steps of each raw material in each input sequence combination corresponding to the audit process ε′ ia , j is the number of the action parameter, j = 1, 2, ..., u, i is the number of the raw material, i = 1, 2, ..., n.

[0053] The sub-steps include purification, dissolution, filtration, dehydration, activation, etc.

[0054] Select the maximum value from the contradiction coefficient of the fusion operation products of the raw materials under each combination of the delivery order Evaluate the severity of raw material reaction conditions in the audit process e is a natural constant.

[0055] In a preferred embodiment, the method for regulating the raw material fusion order in the review process is: comparing the severity of the raw material reaction conditions of the review process with the preset severity threshold, when the severity of the raw material reaction conditions of the review process is lower than the preset severity threshold, extracting the volatility index vl of each raw material corresponding to the preset review process i .

[0056] Extract the static time t of each raw material from the end of the delivery to the end of the implementation process during the implementation of the audit process from the production line execution data repository i, the cycle time and number of sub-steps of each raw material input process corresponding to the audit process, and analyze the processing complexity of each raw material corresponding to the audit process

[0057] Evaluate the expected index of the order of each raw material in the review process In the formula, vl0 represents the volatility index of the raw materials corresponding to the preset reference value, and t0 represents the standing time corresponding to the preset reference value.

[0058] The raw materials corresponding to the review process are numbered sequentially from large to small according to the expected index of the order of release, and recorded as the prior number group of the raw materials.

[0059] Using a sequence alignment algorithm, the raw material's pre-sequence number group is compared with each delivery sequence combination, and the delivery sequence combination closest to the raw material's pre-sequence number group is identified and recorded as the raw material's analog sequence group.

[0060] Extract the contradiction coefficient of the fusion operation product of the raw materials belonging to the audit process under the analogy sequence group, and compare it with the preset safety value of the contradiction coefficient of the fusion operation product. When it is less than the preset safety value of the contradiction coefficient of the fusion operation product, adjust the order of the raw materials placed in the audit process according to the analogy sequence group of the raw materials.

[0061] In another preferred embodiment, the calculation formula for the processing complexity of each raw material in the evaluation and approval process is: Where T i 、N i They respectively represent the cycle time and number of sub-steps of the i-th raw material input process corresponding to the audit process, and T0 represents the preset reference cycle time.

[0062] Combined with the control range of each action parameter of the audit process under each delivery sequence combination, the contradiction coefficient of the fusion operation product of the raw materials under each delivery sequence combination, and the change range of the sub-steps of the audit process corresponding to each raw material under each delivery sequence combination, we jointly construct a display list of the raw material sequence change results and provide feedback display.

[0063] The present invention conducts experiments by combining the raw materials corresponding to the process where the unexpected components are located in various order of addition, and combines the volatility index, processing complexity, and standing time of each raw material to obtain a more efficient fusion order, thereby improving the synthesis efficiency of the product.

[0064] The production line execution data storage library is used to store the total amount of components of pharmaceutical intermediate synthesis products, the component content of target products and by-products in pharmaceutical intermediate synthesis products, various product components and their contents of each synthesis process, store the actual control value of each action parameter corresponding to each synthesis process, store the recent correction record of the control equipment to which the identification parameters of the audit process belong, store the fusion ratio record of each raw material corresponding to the audit process, store the static time of each raw material from the end of the release time to the end of the implementation process during the implementation of the audit process, and the cycle time and number of sub-steps of the raw material input process corresponding to the audit process.

[0065] The present invention periodically detects the purity of pharmaceutical intermediates. When the purity of the synthesized product is insufficient, the cause of insufficient purity of the pharmaceutical intermediate production is determined based on four analysis measures, namely, deviation in the operation accuracy of action parameters, unreasonable setting parameters, deviation in the proportion of raw materials, and unreasonable raw material fusion sequence. The problem is then quickly located, thus shortening the fault resolution cycle.

[0066] The above contents are merely examples and explanations of the concept of the present invention. Those skilled in the art may make various modifications or additions to the specific embodiments described or replace them in a similar manner. As long as they do not deviate from the concept of the invention or exceed the scope defined by the present invention, they shall all fall within the protection scope of the present invention.

Claims

1. An intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line, characterized in that: The system includes: The production line synthesis data extraction module is used to obtain the preset pharmaceutical intermediate synthesis process route, including each synthesis process corresponding to each action parameter and each synthesis process corresponding to each raw material; The synthesis product purity analysis module is used to extract the total amount of pharmaceutical intermediate synthesis product components, various product components and their contents in each synthesis process, determine the purity of pharmaceutical intermediate synthesis products, and locate unexpected components in the audit process when the purity is insufficient; The action parameter operation precision judgment module is used to extract the actual control value of each action parameter corresponding to each synthesis process, and determine whether the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is related to the deviation of the action parameter control precision; The parameter rationality judgment module is set to extract the identification parameters of the audit process when the purity of the pharmaceutical intermediate synthesis product is insufficient and the deviation of the action parameter control accuracy is related to the identification parameters of the audit process. It is used to judge whether the setting of the identification parameters of the audit process is reasonable; The rationality judgment module of the release ratio is used to extract the raw material fusion ratio records corresponding to the audit process and judge its operation compliance status when the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is not related to the deviation of the action parameter control accuracy; The fusion product analysis module for drug sequence change is used to conduct change tests on the raw material delivery sequence combination, record the raw material fusion operation information corresponding to the approval process, and evaluate the conflict coefficient of the fusion operation product of the raw materials belonging to the approval process under each delivery sequence combination; The raw material implementation sequence control module is used to evaluate the severity of the raw material reaction conditions in the review process, and then control the raw material fusion sequence in the review process.

2. The intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line according to claim 1, characterized in that: The specific determination of the purity of the synthetic product of the pharmaceutical intermediate is: Extract the content of target products and by-products in the synthetic product of pharmaceutical intermediates, compare it with the total amount of the synthetic product of pharmaceutical intermediates, and obtain the target product generation compliance and by-product generation regularity of the synthetic product of pharmaceutical intermediates; Based on the compliance degree of target product generation and the regularity of by-product generation of pharmaceutical intermediate synthesis products, the purity of pharmaceutical intermediate synthesis products is comprehensively evaluated.

3. The intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line according to claim 1, characterized in that: The method of locating the unexpected components of the audit process is specifically: comparing the various product components and their contents of each synthesis process with the various conventional product components preset in each synthesis process. When a certain product component of a synthesis process does not match the various conventional product components preset in the corresponding preset synthesis process, the product component of the synthesis process is marked as an unexpected component of the audit process.

4. The intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line according to claim 1, characterized in that: The specific process of determining whether the reason for insufficient purity of the synthetic product of the pharmaceutical intermediate is related to the deviation of the action parameter control accuracy is as follows: Compare the actual control value of each action parameter corresponding to each synthesis process with the preset value of the action parameter corresponding to the corresponding synthesis process to obtain the operation deviation value of each action parameter corresponding to each synthesis process; If the operation deviation values ​​of each action parameter corresponding to each synthesis process are within the preset upper and lower limits of the reaction safety, it is determined that the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is not related to the deviation of the action parameter control accuracy; If the operation deviation value of a certain action parameter corresponding to a certain synthesis process is not within the preset upper and lower limits of the reaction safety, the action parameter corresponding to the synthesis process is recorded as the identification parameter of the verification process; Compare the verification process with the audit process. If they match, it is determined that the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is related to the deviation in the precision of the action parameter control, and the identification parameters of the verification process are the identification parameters of the audit process; if they do not match, it is determined that the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is not related to the deviation in the precision of the action parameter control.

5. The intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line according to claim 4, characterized in that: The determination of whether the identification parameter settings of the audit process are reasonable includes: Extract the recent correction records of the control equipment belonging to each synthesis process of the audit process. If the control equipment belonging to the identification parameters of the audit process has a correction record, it is determined that the setting of the identification parameters of the audit process is unreasonable, and then give early warning feedback on its unreasonable setting; Otherwise, deviation correction feedback will be given to the identification parameters of the audit process.

6. The intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line according to claim 1, characterized in that: The extraction review process corresponds to the raw material fusion ratio record, and the specific contents of judging its operational compliance status include: Extract the preset requirements corresponding to the raw material fusion ratio operation of the audit process, and compare them with the corresponding requirements in the raw material fusion ratio record of the audit process. If a requirement deviates from the preset requirement, the operation compliance status of the raw material fusion ratio record of the audit process is recorded as non-compliant; When the operation compliance status is operation compliance, it is determined that the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is not related to the non-compliance of the raw material fusion ratio; When the operation compliance status is non-compliant operation, extract the requirement conditions with deviations, and extract the expected product components corresponding to the requirement conditions under the deviation status, and compare them with the unexpected components of the audited process. If they match, it is determined that the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is related to the non-compliant fusion ratio of the raw materials; if they do not match, it is determined that the reason for the insufficient purity of the synthetic product of the pharmaceutical intermediate is not related to the non-compliant fusion ratio of the raw materials.

7. The intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line according to claim 1, characterized in that: The evaluation of the contradiction coefficient of the fusion operation product of the raw materials belonging to the audit process under each combination of delivery sequence is as follows: the product change information of the raw materials belonging to the audit process under each combination of delivery sequence is obtained, and the product change information includes the increase or decrease of the target product, the increase or decrease of the by-product, and the increase of the abnormal component, which are recorded as , evaluate the contradiction coefficient of the fusion operation products of the raw materials belonging to the audit process under each combination of delivery sequence , is the number of the delivery sequence combination. .

8. The intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line according to claim 7, characterized in that: The corresponding contents of the harshness of the raw material reaction conditions in the evaluation and review process include: Extract the control range of each action parameter of the audit process under each combination of delivery sequence , the change range of sub-steps corresponding to each raw material in each input sequence combination in the audit process , is the number of the action parameter, , is the number of the raw material, ; Select the maximum value from the contradiction coefficient of the fusion operation products of the raw materials under each combination of the delivery order , evaluate the severity of raw material reaction conditions in the audit process , e is a natural constant.

9. The intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line according to claim 8, characterized in that: The method for regulating the order of raw material fusion in the audit process is: Compare the severity of the raw material reaction conditions of the audit process with the preset severity threshold. When the severity of the raw material reaction conditions of the audit process is lower than the preset severity threshold, extract the volatility index of each raw material corresponding to the preset audit process. ; Extract the static time of each raw material from the end of the delivery to the end of the implementation process during the audit process , the cycle time and number of sub-steps of each raw material input process corresponding to the audit process, and analyze the processing complexity of each raw material corresponding to the audit process ; Evaluate the expected index of the order of each raw material in the review process , where Indicates the volatility index of raw materials corresponding to the preset reference value. Indicates that the static time corresponds to the preset reference value; According to the expected index of the order of delivery, the raw materials corresponding to the audit process are numbered in descending order, and recorded as the raw material prior number group; Using a sequence alignment algorithm, the raw material's pre-sequence number group is compared with each delivery sequence combination, and the delivery sequence combination closest to the raw material's pre-sequence number group is identified and recorded as the raw material's analog sequence group; Extract the contradiction coefficient of the fusion operation product of the raw materials belonging to the audit process under the analogy sequence group, and compare it with the preset safety value of the contradiction coefficient of the fusion operation product. When it is less than the preset safety value of the contradiction coefficient of the fusion operation product, adjust the order of the raw materials placed in the audit process according to the analogy sequence group of the raw materials.

10. The intelligent monitoring and control system for a pharmaceutical intermediate synthesis production line according to claim 9, characterized in that: The calculation formula for the processing complexity of each raw material corresponding to the evaluation and approval process is: ,in , Respectively indicate the audit process corresponding to The cycle time and number of sub-steps of the raw material input process, Indicates the preset reference cycle time.

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