Real-time monitoring method and system for drug raw material generation process

Abstract

The invention relates to the technical field of drug analysis, and particularly discloses a real-time monitoring method and system for a drug raw material generation process, and the method comprises the steps: collecting reactant use data, equipment state data and production process data; processing the reactant use data to obtain a reaction process evaluation index, and matching according to the reaction process evaluation index to obtain a current reaction stage; processing the equipment state data to obtain an equipment state abnormity evaluation value, processing to obtain a production process stability evaluation value, and comprehensively analyzing to obtain a drug raw material generation quality evaluation value; and evaluating the drug raw material generation process according to the drug raw material generation quality evaluation value. According to the real-time monitoring method and system for the drug raw material generation process, the quality consistency of the drug raw materials can be ensured, potential quality problems in the raw materials can be found in time, corresponding measures are taken for correction, the quality risk of drug production is reduced, and the curative effect of drugs is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of drug analysis, and in particular to a real-time monitoring method and system for a drug raw material production process. Background Art

[0002] At present, the drug raw material generation process is a very important part of the field of drug analysis technology. With the advancement of technology and the growth of market demand, it has become the norm to provide more refined real-time monitoring methods for the drug raw material generation process. An efficient and accurate real-time monitoring system for the drug raw material generation process is of great significance for improving raw material utilization efficiency and ensuring product quality.

[0003] For example, the invention patent with announcement number CN118278618B is a process monitoring and recording method and system in the drug production process, which involves the field of process monitoring technology, including: classifying the process nodes in the drug production process to obtain the first type of process nodes and the second type of process nodes, the first type of process nodes are the raw material processing process nodes of the drug production process, and the second type of process nodes are the packaging process nodes of the drug production process; establishing a process monitoring main blockchain according to the first type of process nodes; generating multiple process monitoring branch blockchains according to the second type of process nodes; connecting to obtain multiple process monitoring blockchains; and using multiple process monitoring blockchains to monitor and warn the entire drug production process.

[0004] For example, the invention patent with announcement number CN116777251A is a pharmaceutical preparation process monitoring and analysis system based on the whole process, including a pharmaceutical preparation key process acquisition module, a raw material inspection process raw material quality inspection module, a drug mixing process judgment module, a preparation reference library, a drug mixing process mixing state monitoring module, a drug reaction process judgment module, and a drug reaction process reaction state monitoring module. Starting from raw material inspection, drug mixing and drug reaction processes, the inspection indicators of drug raw materials in the raw material inspection process are scientifically and reasonably arranged, so that the efficiency of drug raw material inspection is greatly improved, and the drug mixing state is dynamically monitored in the drug mixing process, which improves the reliability of the drug mixing monitoring results. At the same time, the reaction process and reaction state monitoring is carried out in the drug reaction process, which provides original and reliable data support for tracing the abnormal drug reaction quality.

[0005] However, in the process of implementing the technical solution of the invention in the embodiments of the present application, the present application discovered that the above technology has at least the following technical problems: currently, the process of producing drug raw materials pays more attention to the quality of the drug raw materials, but in the process of producing drug raw materials, external factors have different effects on different reaction stages, and it is difficult to guarantee the raw material utilization efficiency and product quality. Summary of the invention

[0006] In view of the deficiencies in the prior art, the present invention provides a real-time monitoring method and system for a drug raw material production process, which can effectively solve the problems involved in the above-mentioned background technology.

[0007] To achieve the above objectives, the present invention is implemented through the following technical solutions: The first aspect of the present invention provides a real-time monitoring method for the drug raw material production process, including: monitoring the drug raw material production process, collecting reactant usage data, equipment status data and production process data.

[0008] The reactant usage data is processed to obtain a reaction progress evaluation index, the current reaction stage is obtained according to the reaction progress evaluation index, and the reference production process data of the current reaction stage is obtained.

[0009] The equipment status data is processed to obtain the equipment status abnormality assessment value, and the production process stability assessment value is obtained by reference to the production process data and the production process data. The drug raw material generation quality assessment value is obtained through comprehensive analysis.

[0010] The drug raw material production process is evaluated according to the drug raw material production quality evaluation value, and the evaluation results are obtained and fed back.

[0011] As a further method, the reactant usage data is processed to obtain a reaction progress evaluation index, and the specific processing process is: the reactant usage data includes concentrations and water contents of various reactants.

[0012] The critical reactant concentration, allowable deviation water content and reference standard water content were extracted from the drug raw material database, and the reaction progress evaluation index was obtained through comprehensive analysis.

[0013] As a further method, the current reaction stage is obtained by matching the reaction progress evaluation index, and the reference production process data of the current reaction stage is obtained. The specific matching process is: the reaction progress evaluation index is input into the drug raw material database to match the current reaction stage and the reference production process data of the current reaction stage, and the reference production process data of the current reaction stage includes the reference standard humidity, reference standard catalyst dosage, reference standard pH value, reference standard air pressure and reference standard stirring speed of the current reaction stage.

[0014] As a further method, the equipment status data is processed to obtain an equipment status abnormality assessment value, and the specific processing process is: the equipment status data includes the temperature of each temperature monitoring point, the pressure of each pressure monitoring point, the equipment noise intensity, the vibration frequency of each vibration monitoring point and the equipment energy consumption.

[0015] The reference standard temperature, critical equipment noise intensity, reference standard vibration frequency, allowable deviation vibration frequency, allowable deviation temperature, reference standard equipment energy consumption and allowable deviation equipment energy consumption are extracted from the pharmaceutical raw material database, and a comprehensive analysis is performed to obtain the equipment status abnormality assessment value, and feedback is provided based on the equipment status abnormality assessment value.

[0016] As a further method, the production process stability evaluation value is obtained based on reference production process data and production process data processing. The specific processing process is: the production process data includes humidity, catalyst dosage, pH value, air pressure and stirring speed at each time node in the reaction equipment.

[0017] The allowable deviation of humidity, allowable deviation of catalyst dosage, allowable deviation of pH value, allowable deviation of air pressure and allowable deviation of stirring speed are extracted from the pharmaceutical raw material database, and the production process stability assessment value is obtained through comprehensive analysis.

[0018] As a further method, the comprehensive analysis obtains a drug raw material production quality assessment value, and the specific assessment process is: based on the equipment status abnormality assessment value and the production process stability assessment value, a comprehensive analysis is performed to obtain a drug raw material production quality assessment value, and the drug raw material production quality assessment value is used to quantitatively evaluate the quality of the drug raw material production process.

[0019] As a further method, the drug raw material generation process is evaluated according to the drug raw material generation quality evaluation value. The specific evaluation process is: extracting the drug raw material generation quality evaluation threshold from the drug raw material database, comparing the drug raw material generation quality evaluation value with the drug raw material generation quality evaluation threshold, if the drug raw material generation quality evaluation value is greater than or equal to the drug raw material generation quality evaluation threshold, then the drug raw material generation process is evaluated as qualified, if the drug raw material generation quality evaluation value is less than the drug raw material generation quality evaluation threshold, then the drug raw material generation process is evaluated as unqualified.

[0020] As a further method, feedback is provided based on the equipment status abnormality evaluation value. The specific process is as follows: extracting the equipment status abnormality evaluation threshold from the drug raw material database; if the equipment status abnormality evaluation value is greater than or equal to the equipment status abnormality evaluation threshold, the drug raw material generation process is immediately terminated and an early warning is issued; if the equipment status abnormality evaluation value is less than the equipment status abnormality evaluation threshold, no additional operation is performed.

[0021] As a further method, the device status abnormality evaluation value is specifically expressed as: ; in, represents the abnormal evaluation value of the equipment status, e represents the natural constant, represents the temperature of the ith temperature monitoring point, Indicates the reference standard temperature, Indicates the allowable deviation temperature, represents the pressure at the jth pressure monitoring point, Indicates the noise intensity of the device. represents the critical equipment noise intensity, represents the vibration frequency of the kth vibration monitoring point, Indicates the reference standard vibration frequency, Indicates the allowable deviation vibration frequency, Indicates the energy consumption of the device. Indicates the energy consumption of reference standard equipment, Indicates the allowable deviation of equipment energy consumption, Indicates the impact factor of the equipment status abnormality assessment corresponding to the set temperature. Indicates the impact factor of equipment status abnormality assessment corresponding to the set pressure, Indicates the equipment status abnormality assessment impact factor corresponding to the set equipment noise intensity, Indicates the equipment status abnormality assessment impact factor corresponding to the set vibration frequency. It represents the equipment status abnormality assessment impact factor corresponding to the set equipment energy consumption, i represents the number of each temperature monitoring point, i=1,2,3,...,m, m represents the total number of temperature monitoring points, j represents the number of each pressure monitoring point, j=1,2,3,...,n, n represents the total number of pressure monitoring points, k represents the number of each vibration monitoring point, k=1,2,3,...,s, s represents the total number of vibration monitoring points.

[0022] The second aspect of the present invention provides a real-time monitoring system for a drug raw material production process, comprising: a drug data acquisition module for monitoring the drug raw material production process, collecting reactant usage data, equipment status data and production process data.

[0023] The reaction stage matching module is used to process the reactant usage data to obtain the reaction process evaluation index, match the current reaction stage according to the reaction process evaluation index, and obtain the reference production process data of the current reaction stage.

[0024] The drug raw material generation quality analysis module is used to process the equipment status data to obtain the equipment status abnormality assessment value, obtain the production process stability assessment value based on the reference production process data and production process data processing, and obtain the drug raw material generation quality assessment value through comprehensive analysis.

[0025] The drug raw material production process evaluation module is used to evaluate the drug raw material production process according to the drug raw material production quality evaluation value, obtain the evaluation results and provide feedback.

[0026] The drug raw material database is used to store drug raw material related data, including: critical reactant concentration, allowable deviation water content, reference standard water content, reference standard temperature, critical equipment noise intensity, reference standard vibration frequency, allowable deviation vibration frequency, allowable deviation temperature, reference standard equipment energy consumption, allowable deviation equipment energy consumption, allowable deviation humidity, allowable deviation catalyst dosage, allowable deviation pH value, allowable deviation air pressure, allowable deviation stirring speed, reference standard humidity, reference standard catalyst dosage, reference standard pH value, reference standard air pressure, reference standard stirring speed, drug raw material generation quality assessment influencing factor corresponding to the set equipment status abnormality assessment value, drug raw material generation quality assessment influencing factor corresponding to the set production process stability assessment value, equipment status abnormality assessment threshold and drug raw material generation quality assessment threshold.

[0027] Compared with the prior art, the embodiments of the present invention have at least the following advantages or beneficial effects: (1) The present invention provides a real-time monitoring method and system for the production process of pharmaceutical raw materials, which can ensure the quality consistency of pharmaceutical raw materials, avoid drug quality problems caused by raw material quality fluctuations, and help to timely discover potential quality problems in raw materials, so as to take corresponding measures to correct them, reduce the quality risks of drug production, and improve the efficacy of drugs; (2) By evaluating the abnormal evaluation value of the equipment status, the present invention can reasonably arrange production tasks and equipment operation, avoid equipment overload or idleness, improve equipment utilization and production efficiency, and ensure that production equipment operates under stable conditions. Furthermore, by timely discovering and handling equipment failures, it can reduce the generation of defective and waste products caused by equipment problems, and improve product quality and qualification rate; (3) The present invention can reflect the weak links and potential problems in the production process of drug raw materials by evaluating the stability evaluation value of the production process, which helps to accurately identify production bottlenecks, thereby making targeted optimization and improvements and improving overall production efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The present invention is further described with the aid of the accompanying drawings, but the embodiments in the accompanying drawings do not constitute any limitation to the present invention. A person skilled in the art can obtain other accompanying drawings based on the following accompanying drawings without creative work. Figure 1 It is a schematic diagram of the method flow of the present invention; Figure 2 It is a schematic diagram of system module connection of the present invention; Figure 3 A schematic diagram of the functional relationship between the quality assessment value of the drug raw material generated by the present invention and the production process stability assessment value. DETAILED DESCRIPTION

[0029] The technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0030] Reference Figure 1 As shown, the first aspect of the present invention provides a real-time monitoring method for a drug raw material production process, comprising: monitoring the drug raw material production process, collecting reactant usage data, equipment status data and production process data.

[0031] The reactant usage data is processed to obtain a reaction progress evaluation index, the current reaction stage is obtained according to the reaction progress evaluation index, and the reference production process data of the current reaction stage is obtained.

[0032] The equipment status data is processed to obtain the equipment status abnormality assessment value, and the production process stability assessment value is obtained by reference to the production process data and the production process data. The drug raw material generation quality assessment value is obtained through comprehensive analysis.

[0033] The drug raw material production process is evaluated according to the drug raw material production quality evaluation value, and the evaluation results are obtained and fed back.

[0034] Specifically, the reactant usage data is processed to obtain a reaction progress evaluation index, and the specific processing process is as follows: the reactant usage data includes concentrations and water contents of various reactants.

[0035] The critical reactant concentration, allowable deviation water content and reference standard water content were extracted from the drug raw material database, and the reaction progress evaluation index was obtained through comprehensive analysis.

[0036] In a specific embodiment, sampling points are set at key steps and stages of the production of drug raw materials, such as the start of the reaction, the middle of the reaction, the end of the reaction and any possible intermediate steps. Sampling is performed using a clean and dry sampling tool, and the concentration of various reactants is obtained by spectroscopy. Appropriate concentrations can promote effective collisions between reactants, increase the reaction rate, and thus shorten the reaction time. By precisely controlling the concentration of the reactants, it is possible to ensure that the reaction is carried out under optimal conditions, thereby improving the reaction efficiency. The water content is obtained by a reduced pressure drying method. The water content is one of the important factors affecting the production process of drug raw materials. By precisely controlling the water content, the stability and controllability of the reaction system can be ensured.

[0037] Furthermore, the reaction progress evaluation index, the specific numerical expression is: ; in, represents the reaction progress evaluation index, represents the concentration of the jth reactant, represents the reference standard reactant concentration of the jth reactant, represents the allowable deviation reactant concentration of the jth reactant, Indicates the water content, Indicates the reference standard water content, Indicates the allowable deviation moisture content, Indicates the reaction process evaluation impact factor corresponding to the set reactant concentration, It represents the reaction process evaluation impact factor corresponding to the set water content, j represents the number of each reactant type, j=1,2,3,...,n, and n represents the total number of reactant types.

[0038] The algorithm of this embodiment combines the concentrations and water contents of various reactants, and comprehensively analyzes to obtain the reaction progress evaluation index. In some cases, the concentrations and water contents of the reactants may restrict each other. For example, when the concentration of the reactants is high, in order to maintain the stability of the reaction system, it may be necessary to reduce the water content. Conversely, when the water content is high, in order to maintain the reaction rate and product purity, it may be necessary to appropriately increase the concentration of the reactants. Comprehensive analysis can obtain a more comprehensive, accurate and in-depth reaction progress evaluation index.

[0039] Table 1 Example of reaction progress evaluation index data: ; As shown in Table 1, the reaction progress evaluation index is jointly determined by the concentrations of various reactants and the water content. In a specific embodiment, n=1, the reference standard reactant concentration is 25%, the allowable deviation reactant concentration is 5%, the reference standard water content is 5%, the allowable deviation water content is 2%, the set reactant concentration corresponds to a reaction progress evaluation impact factor of 0.4, and the set water content corresponds to a reaction progress evaluation impact factor of 0.3. This formula takes into account two key factors, namely the concentrations of various reactants and the water content, which can reduce the generation of impurities and by-products, thereby improving the purity of the drug, helping to ensure the effectiveness and safety of the drug, and can also reduce unnecessary energy consumption and waste of raw materials, thereby shortening the reaction time and improving production efficiency. By standardizing the concentrations and water contents of various reactants and ensuring that they are compared at the same order of magnitude, the fairness and comparability of the evaluation are improved, and at the same time The setting can avoid side reactions and increased energy consumption caused by excessive concentration, and ensure the purity and quality of the reaction products. The setting can reduce the loss of drug raw materials in the preparation process and improve the yield. By weighting the influence of the concentration and water content of various reactants, their relative importance in the evaluation index can be reflected. The weights of different factors can be adjusted according to different needs, making the model highly adaptable. It is not difficult to see that the smaller the deviation of the concentration or water content of various reactants, the larger the reaction process evaluation index. By evaluating the reaction process evaluation index, we can accurately understand the conversion rate and reaction rate of the reactants under different conditions, so as to find the optimal reaction conditions and improve production efficiency. We can also adjust the reaction conditions in time to avoid stagnation or overreaction during the reaction process, thereby shortening the production cycle. Further, by optimizing the reaction conditions, we can improve the purity of the product and reduce the impurity content, thereby ensuring the safety and effectiveness of the drug.

[0040] It should be understood that in this embodiment and They are reaction process evaluation influencing factors corresponding to various reactant concentrations and water contents preset in the drug raw material database, and represent numerical values ​​of the degree of influence of various reactant concentrations and water contents on the reaction process evaluation index. They can be directly obtained from the drug raw material database when used, and their corresponding relationship can be a preset mapping relationship. For example, various reactant concentrations and water contents and reaction process evaluation influencing factors corresponding to various reactant concentrations and water contents preset in the drug raw material database form a mapping set, and the real-time various reactant concentrations and water contents are input into the mapping set to obtain the reaction process evaluation influencing factors corresponding to various reactant concentrations and water contents. The mapping relationship can be one-to-one or many-to-one. In this example, its value range is between 0 and 1.

[0041] It should be explained that the reaction progress evaluation index in this embodiment is a quantitative indicator obtained by analyzing the concentration and water content of various reactants, and is used to quantify the degree of reaction.

[0042] Furthermore, the current reaction stage is obtained according to the reaction progress evaluation index, and the reference production process data of the current reaction stage is obtained. The specific matching process is: the reaction progress evaluation index is input into the drug raw material database to match the current reaction stage and the reference production process data of the current reaction stage, and the reference production process data of the current reaction stage includes the reference standard humidity, reference standard catalyst dosage, reference standard pH value, reference standard air pressure and reference standard stirring speed of the current reaction stage.

[0043] Specifically, the equipment status data is processed to obtain an equipment status abnormality assessment value, and the specific processing process is: the equipment status data includes the temperature of each temperature monitoring point, the pressure of each pressure monitoring point, the equipment noise intensity, the vibration frequency of each vibration monitoring point and the equipment energy consumption.

[0044] The reference standard temperature, critical equipment noise intensity, reference standard vibration frequency, allowable deviation vibration frequency, allowable deviation temperature, reference standard equipment energy consumption and allowable deviation equipment energy consumption are extracted from the pharmaceutical raw material database, and a comprehensive analysis is performed to obtain the equipment status abnormality assessment value, and feedback is provided based on the equipment status abnormality assessment value.

[0045] In a specific embodiment, a high or low temperature environment may cause the drug raw material to deteriorate, degrade or produce adverse reactions. Temperature monitoring helps to detect temperature anomalies in time and prevent the occurrence of quality problems. The temperature of each temperature monitoring point can be obtained through a temperature sensor. Pressure is one of the important factors affecting the chemical reaction rate and the separation effect of substances. By accurately controlling the reaction pressure, it is helpful to obtain drug raw materials with higher purity and fewer impurities. The pressure of each pressure monitoring point can be obtained through a pressure sensor. Excessive noise will interfere with the concentration and focus of production personnel and even affect the accuracy of operations. Noise intensity monitoring helps to reduce noise interference and improve production accuracy. The noise intensity of the equipment can be obtained by installing a noise meter on the top of the equipment. Abnormal equipment vibration may cause production interruption or unstable product quality. Vibration monitoring helps to detect and solve problems in time and improve production efficiency. The vibration frequency of each vibration monitoring point can be obtained through a vibration sensor. By monitoring the energy consumption of the equipment, energy waste problems can be discovered in time, and energy-saving measures can be taken to reduce energy costs. The energy consumption of the equipment can be obtained through an energy consumption monitor.

[0046] Furthermore, the specific numerical expression of the abnormal equipment status evaluation value is: ; in, represents the abnormal evaluation value of the equipment status, e represents the natural constant, represents the temperature of the ith temperature monitoring point, Indicates the reference standard temperature, Indicates the allowable deviation temperature, represents the pressure at the jth pressure monitoring point, Indicates the noise intensity of the device. represents the critical equipment noise intensity, represents the vibration frequency of the kth vibration monitoring point, Indicates the reference standard vibration frequency, Indicates the allowable deviation vibration frequency, Indicates the energy consumption of the device. Indicates the energy consumption of reference standard equipment, Indicates the allowable deviation of equipment energy consumption, Indicates the impact factor of the equipment status abnormality assessment corresponding to the set temperature. Indicates the impact factor of equipment status abnormality assessment corresponding to the set pressure, Indicates the equipment status abnormality assessment impact factor corresponding to the set equipment noise intensity, Indicates the equipment status abnormality assessment impact factor corresponding to the set vibration frequency. It represents the equipment status abnormality assessment impact factor corresponding to the set equipment energy consumption, i represents the number of each temperature monitoring point, i=1,2,3,...,m, m represents the total number of temperature monitoring points, j represents the number of each pressure monitoring point, j=1,2,3,...,n, n represents the total number of pressure monitoring points, k represents the number of each vibration monitoring point, k=1,2,3,...,s, s represents the total number of vibration monitoring points.

[0047] The algorithm of this embodiment combines the temperature of each temperature monitoring point, the pressure of each pressure monitoring point, the equipment noise intensity, the vibration frequency of each vibration monitoring point and the equipment energy consumption in the process of drug raw material production, and comprehensively analyzes to obtain the equipment status abnormality assessment value. As the temperature rises, the thermal stress inside the equipment increases, which may cause deformation or loosening of equipment parts, thereby generating noise. High temperature may also accelerate the oxidation and deterioration of the lubricating oil inside the equipment, resulting in poor lubrication and increased noise. Under high pressure environment, the stress inside the equipment increases, which may cause wear or damage to equipment parts, thereby generating noise. At the same time, high pressure may also cause fluid vibration and turbulence inside the equipment, further increasing the noise level. High temperature may also cause internal materials of the equipment to The thermal stress of the material changes, resulting in changes in the vibration frequency. At the same time, high pressure may also cause deformation or loosening of equipment components, further affecting the vibration frequency. High temperature may increase friction inside the equipment, thereby increasing energy consumption. At the same time, under high pressure conditions, the equipment may need to consume more energy to overcome pressure resistance, thereby increasing energy consumption. Furthermore, the generation of equipment noise is often accompanied by energy loss and waste. For example, noise may be caused by friction, vibration or fluid turbulence inside the equipment. These processes will consume energy. At the same time, the increase in vibration frequency may lead to increased friction and wear inside the equipment, thereby increasing energy consumption. Comprehensive analysis can obtain more comprehensive, accurate and in-depth equipment status abnormality assessment values.

[0048] It should be explained that five key factors, namely temperature, pressure, equipment noise intensity, vibration frequency and equipment energy consumption, are considered in this embodiment, which can timely detect abnormal conditions in the production process and take corresponding adjustment measures, thereby optimizing process conditions and improving production efficiency, helping to timely detect potential equipment failures, such as bearing wear and looseness, so as to timely repair or replace them, reduce downtime caused by equipment failure, ensure that chemical reactions are carried out under optimal conditions, thereby improving product purity and consistency, and help to timely detect equipment energy efficiency problems, such as poor lubrication and loose sealing, so as to timely repair them and avoid energy waste, and timely detect potential safety hazards, such as overheating and overpressure, so as to take timely measures to prevent safety accidents, and help to timely detect abnormal conditions of equipment, such as overload and excessive vibration, so as to timely stop and check and protect equipment safety. By standardizing temperature, pressure, equipment noise intensity, vibration frequency and equipment energy consumption, ensuring that they are compared at the same magnitude, the fairness and comparability of the evaluation are improved. By weighting the impact of temperature, pressure, equipment noise intensity, vibration frequency and equipment energy consumption, their relative importance in the evaluation index is reflected. The weights of different factors can be adjusted according to different needs, making the formula highly adaptable. It is not difficult to see that the greater the temperature deviation or pressure deviation or equipment noise intensity or vibration frequency deviation or equipment energy consumption deviation, the greater the abnormal equipment status evaluation value. By evaluating the abnormal equipment status evaluation value, production tasks and equipment operations can be reasonably arranged to avoid equipment overload or idleness, improve equipment utilization and production efficiency, and ensure that production equipment operates under stable conditions, thereby ensuring the consistency and stability of product quality. Further, by timely discovering and handling equipment failures, the generation of defective and waste products caused by equipment problems can be reduced, and product quality and qualification rates can be improved.

[0049] It should be understood that in this embodiment , , , and They are respectively the equipment state abnormality assessment influencing factors corresponding to the temperature, pressure, equipment noise intensity, vibration frequency and equipment energy consumption preset in the drug raw material database, representing the numerical values ​​of the degree of influence of temperature, pressure, equipment noise intensity, vibration frequency and equipment energy consumption on the equipment state abnormality assessment index. They can be directly obtained from the drug raw material database when used, and the corresponding relationship can be a preset mapping relationship. For example, the temperature, pressure, equipment noise intensity, vibration frequency and equipment energy consumption form a mapping set with the equipment state abnormality assessment influencing factors corresponding to the temperature, pressure, equipment noise intensity, vibration frequency and equipment energy consumption preset in the drug raw material database. The real-time temperature, pressure, equipment noise intensity, vibration frequency and equipment energy consumption are input into the mapping set to obtain the equipment state abnormality assessment influencing factors corresponding to the temperature, pressure, equipment noise intensity, vibration frequency and equipment energy consumption. The mapping relationship can be one-to-one or many-to-one. In this example, the value range is between 0 and 1.

[0050] It should be explained that the equipment status abnormality assessment value in this embodiment is a quantitative indicator obtained by analyzing the temperature of each temperature monitoring point, the pressure of each pressure monitoring point, the equipment noise intensity, the vibration frequency of each vibration monitoring point and the equipment energy consumption, and is used to quantify the degree of abnormality of the equipment status.

[0051] Specifically, the production process stability evaluation value is obtained based on reference production process data and production process data processing, and the specific processing process is: the production process data includes humidity, catalyst dosage, pH value, air pressure and stirring speed at each time node in the reaction equipment.

[0052] The allowable deviation of humidity, allowable deviation of catalyst dosage, allowable deviation of pH value, allowable deviation of air pressure and allowable deviation of stirring speed are extracted from the pharmaceutical raw material database, and a comprehensive analysis is performed to obtain the production process stability assessment value.

[0053] In a specific embodiment, humidity is one of the key factors affecting the quality of drugs. In the process of drug raw material production, excessively high or low humidity may affect the stability, solubility and microbial contamination of drugs. By monitoring the humidity at each time point, it can be ensured that the production process is carried out within an appropriate humidity range, thereby ensuring the quality of the drug. The humidity at each time point can be obtained through a humidity sensor. The catalyst is an auxiliary agent that promotes chemical reactions, and its dosage has a significant effect on the reaction rate and product selectivity. By monitoring the amount of catalyst at each time point, it can be ensured that the amount of catalyst is within the optimal range, thereby optimizing the reaction rate and improving production efficiency. The amount of catalyst at each time point can be directly recorded. The pH value is an important factor affecting chemical reactions. One of the important factors. During the production process of drug raw materials, by monitoring the pH value at each time point, it can be ensured that the reaction conditions are stable within an appropriate range, so as to obtain high-quality drugs. The pH value at each time point can be obtained by a pH meter. Air pressure is one of the factors affecting the chemical reaction rate and the material separation effect. By accurately controlling the air pressure parameters, the process conditions can be optimized and the production efficiency can be improved. The air pressure at each time point can be obtained by a barometer. Stirring speed is one of the important factors affecting the chemical reaction rate and mixing effect. Stirring speed that is too fast or too slow may lead to unstable product quality. By monitoring the stirring speed, the stirring speed can be discovered and adjusted in time to ensure the consistency and stability of product quality. The speed at each time point can be obtained by a tachometer.

[0054] Furthermore, the specific numerical expression of the production process stability evaluation value is: ; in, Represents the production process stability assessment value, represents the humidity at the xth time node, Indicates reference standard humidity, Indicates the allowable deviation humidity, Indicates the amount of catalyst used at the xth time node, Indicates the reference standard catalyst dosage, represents the allowable deviation of catalyst dosage, e represents the natural constant, represents the pH value at the xth time node, Indicates the reference standard pH value, Indicates the allowable deviation pH value, represents the air pressure at the xth time node, Indicates reference standard air pressure, Indicates the allowable deviation pressure, represents the stirring speed at the xth time node, Indicates the reference standard stirring speed, Indicates the allowable deviation of stirring speed, Indicates the impact factor of the production process stability assessment corresponding to the set humidity, Indicates the impact factor of production process stability assessment corresponding to the set catalyst dosage, Indicates the influencing factor of the production process stability assessment corresponding to the set pH value, Indicates the influencing factor of the production process stability assessment corresponding to the set air pressure, It represents the influencing factor of production process stability assessment corresponding to the set stirring speed, x represents the number of each time node, x=1,2,3,...,y, y represents the total number of time nodes.

[0055] The algorithm of this embodiment combines the humidity, catalyst dosage, pH value, air pressure and stirring speed at each time point in the reaction equipment, and comprehensively analyzes to obtain the production process stability assessment value. Humidity may affect the activity of the catalyst. In some cases, excessive humidity may cause catalyst poisoning or inactivation, so it is necessary to increase the amount of catalyst to maintain the reaction rate. On the other hand, humidity may also affect the solubility of the reactants, and then affect the contact area between the catalyst and the reactants, thereby affecting the amount of catalyst; at the same time, humidity changes may affect the acid-base balance of the reaction system, causing changes in pH value. For example, in some reactions, the presence of water molecules may promote or inhibit proton transfer reactions, thereby affecting the pH value; there is a certain relationship between humidity and air pressure. When the air pressure decreases, water molecules in the air are more likely to evaporate, resulting in increased humidity. This relationship may be more significant in a closed reaction system; humidity It may affect the viscosity and fluidity of the reaction system, and thus affect the stirring effect. For example, in a high humidity environment, some reactants may more easily form a viscous solution, requiring a higher stirring speed to ensure uniform mixing. At the same time, the stirring speed may affect the dispersion of the catalyst in the reaction system and the contact area with the reactants. A higher stirring speed usually contributes to uniform dispersion of the catalyst and a higher reaction rate. In some cases, changes in gas pressure may affect the acid-base balance of the reaction system. For example, in a gas-liquid reaction, changes in gas solubility may lead to changes in the pH value of the solution. Comprehensive analysis can obtain a more comprehensive, accurate and in-depth assessment of the stability of the production process.

[0056] It should be explained that, in the present embodiment, five key factors, i.e. humidity, catalyst dosage, pH value, air pressure and stirring speed at each time node are considered, it can be ensured that the reaction is carried out under the most suitable conditions, so as to improve the controllability of the production process, it is helpful to reduce the fluctuation and deviation in the production process, so that the reaction is more stable, so as to improve the stability assessment value of the production process, and it is also possible to prevent the safety accidents caused by the reaction out of control or equipment failure, by real-time monitoring and adjusting the reaction conditions, it is possible to timely discover and correct potential safety hazards, and stable reaction conditions are helpful to accelerate the reaction rate, shorten the reaction time, so as to improve production efficiency. By standardizing the humidity, catalyst dosage, pH value, air pressure and stirring speed at each time node, it is ensured that they are compared on the same magnitude, and the fairness and comparability of the assessment are improved. By weighting the influence of humidity, catalyst dosage, pH value, air pressure and stirring speed at each time node, it is reflected that their relative importance in the evaluation index can be adjusted according to different needs The weight of different factors makes the formula have good adaptability. It is not difficult to see that the smaller the humidity deviation, catalyst dosage deviation, pH value deviation, air pressure deviation or stirring speed deviation at each time point, the greater the production process stability assessment value. By evaluating the production process stability assessment value, it can reflect the weak links and potential problems in the production process of drug raw materials, help accurately identify production bottlenecks, and thus optimize and improve in a targeted manner, improve overall production efficiency, and timely detect product quality fluctuations, take corresponding measures to intervene, and ensure the consistency and stability of product quality.

[0057] It should be understood that in this embodiment , , , and They are respectively the production process stability assessment influencing factors corresponding to the humidity, catalyst dosage, pH value, air pressure and stirring speed preset in the pharmaceutical raw material database, and represent the numerical values ​​of the influence degree of humidity, catalyst dosage, pH value, air pressure and stirring speed on the production process stability assessment index. When used, they can be directly obtained from the pharmaceutical raw material database, and the corresponding relationship can be a preset mapping relationship. For example, humidity, catalyst dosage, pH value, air pressure and stirring speed form a mapping set with the production process stability assessment influencing factors corresponding to the humidity, catalyst dosage, pH value, air pressure and stirring speed preset in the pharmaceutical raw material database. The real-time humidity, catalyst dosage, pH value, air pressure and stirring speed are input into the mapping set to obtain the production process stability assessment influencing factors corresponding to the humidity, catalyst dosage, pH value, air pressure and stirring speed. The mapping relationship can be one-to-one or many-to-one. In this example, its value range is between 0 and 1.

[0058] It should be explained that the production process stability evaluation value in this embodiment is a quantitative indicator obtained by analyzing the humidity, catalyst dosage, pH value, air pressure and stirring speed at each time node, and is used to quantify the stability of the production process.

[0059] Specifically, a comprehensive analysis is performed to obtain a drug raw material generation quality assessment value, and the specific assessment process is: based on the equipment status abnormality assessment value and the production process stability assessment value, a comprehensive analysis is performed to obtain a drug raw material generation quality assessment value, and the drug raw material generation quality assessment value is used to quantitatively evaluate the quality of the drug raw material generation process.

[0060] Furthermore, the drug raw material generates a quality assessment value, and the specific numerical expression is: ; in, Indicates the quality assessment value of the drug raw material. Indicates the abnormal evaluation value of the device status. Represents the production process stability assessment value, Indicates the drug raw material production quality assessment influencing factor corresponding to the set equipment status abnormality assessment value, It represents the drug raw material production quality assessment influencing factor corresponding to the set production process stability assessment value.

[0061] like Figure 3 As shown, in a specific embodiment, =0.3, =0.4. =0.1, the functional relationship between the drug raw material generation quality assessment value and the production process stability assessment value is shown in curve a; when =0.5, the functional relationship between the drug raw material quality assessment value and the production process stability assessment value is shown in curve b; when =1, the functional relationship between the drug raw material generation quality assessment value and the production process stability assessment value is shown in curve c.

[0062] The algorithm of this embodiment combines the equipment status abnormality assessment value and the production process stability assessment value, and comprehensively analyzes to obtain the drug raw material generation quality assessment value. There is a negative correlation between the equipment status abnormality assessment value and the production process stability assessment value. The equipment is an important part of the production process. The quality of the equipment status directly affects the stability and efficiency of the production process. When the equipment fails or the performance deteriorates, it will lead to instability in the production process or even shutdown. The stability of the production process will also affect the operating status of the equipment. For example, frequent production fluctuations may cause excessive wear or failure of the equipment. At the same time, a stable production process helps to reduce the load and wear of the equipment and extend the service life of the equipment. Comprehensive analysis can obtain a more comprehensive, accurate and in-depth drug raw material generation quality assessment value.

[0063] It should be explained that two key factors are considered in this embodiment, namely the equipment status abnormality evaluation value and the production process stability evaluation value, which can reveal the bottlenecks and unstable factors in the production process. Enterprises can make targeted optimizations and improvements based on this information, and can timely discover and solve the problem of equipment performance degradation or failure, thereby reducing the product defect rate. Stable production processes and efficient equipment operation can reduce the generation of waste and rework, thereby reducing the waste of raw materials and energy, and further improving production efficiency and product quality. By weighting the impact of the equipment status abnormality evaluation value and the production process stability evaluation value, it reflects their relative importance in the evaluation index. The weights of different factors can be adjusted according to different needs, making the formula very adaptable. It is not difficult to see that when the equipment status abnormality evaluation value is smaller or the production process stability evaluation value is larger, the drug raw material generation quality evaluation value is larger. By evaluating the quality assessment value generated by drug raw materials, the quality consistency of drug raw materials can be ensured, and drug quality problems caused by fluctuations in raw material quality can be avoided. It is helpful to timely discover potential quality problems in raw materials, such as impurities, pollution, insufficient content, etc., so that corresponding measures can be taken to correct them, reduce the quality risks of drug production, and ensure that the content of active ingredients in drug raw materials meets the regulations, thereby improving the efficacy of drugs, further promoting enterprises to carry out technological innovation and improvement, and improving the overall level of drug production.

[0064] It should be understood that in this embodiment and They are respectively the drug raw material generation quality assessment influencing factors corresponding to the equipment state abnormality assessment values ​​and the production process stability assessment values ​​preset in the drug raw material database, and represent the numerical values ​​indicating the degree of influence of the equipment state abnormality assessment values ​​and the production process stability assessment values ​​on the drug raw material generation quality assessment index. They can be directly obtained from the drug raw material database when used, and the corresponding relationship can be a preset mapping relationship. For example, the equipment state abnormality assessment value and the production process stability assessment value and the drug raw material generation quality assessment influencing factors corresponding to the equipment state abnormality assessment values ​​and the production process stability assessment values ​​preset in the drug raw material database form a mapping set, and the real-time equipment state abnormality assessment value and the production process stability assessment value are input into the mapping set to obtain the drug raw material generation quality assessment influencing factors corresponding to the equipment state abnormality assessment value and the production process stability assessment value. The mapping relationship can be one-to-one or many-to-one. In this example, the value range is between 0 and 1.

[0065] Specifically, the drug raw material generation process is evaluated according to the drug raw material generation quality evaluation value, and the specific evaluation process is: extracting the drug raw material generation quality evaluation threshold from the drug raw material database, comparing the drug raw material generation quality evaluation value with the drug raw material generation quality evaluation threshold, if the drug raw material generation quality evaluation value is greater than or equal to the drug raw material generation quality evaluation threshold, then the drug raw material generation process is evaluated as qualified, if the drug raw material generation quality evaluation value is less than the drug raw material generation quality evaluation threshold, then the drug raw material generation process is evaluated as unqualified, and the drug raw material is discarded.

[0066] In a specific embodiment, feedback is provided based on the equipment status abnormality assessment value. The specific process is as follows: extracting the equipment status abnormality assessment threshold from the drug raw material database; if the equipment status abnormality assessment value is greater than or equal to the equipment status abnormality assessment threshold, the drug raw material generation process is terminated immediately, and an early warning is issued, that is, relevant staff is notified to perform maintenance; if the equipment status abnormality assessment value is less than the equipment status abnormality assessment threshold, no additional operation is performed.

[0067] Reference Figure 2 As shown, the second aspect of the present invention provides a real-time monitoring system for the drug raw material production process, including: a drug data acquisition module, which is used to monitor the drug raw material production process and collect reactant usage data, equipment status data and production process data.

[0068] The reaction stage matching module is used to process the reactant usage data to obtain the reaction process evaluation index, match the current reaction stage according to the reaction process evaluation index, and obtain the reference production process data of the current reaction stage.

[0069] The drug raw material generation quality analysis module is used to process the equipment status data to obtain the equipment status abnormality assessment value, obtain the production process stability assessment value based on the reference production process data and production process data processing, and obtain the drug raw material generation quality assessment value through comprehensive analysis.

[0070] The drug raw material production process evaluation module is used to evaluate the drug raw material production process according to the drug raw material production quality evaluation value, obtain the evaluation results and provide feedback.

[0071] The drug raw material database is used to store drug raw material related data, including: critical reactant concentration, allowable deviation water content, reference standard water content, reference standard temperature, critical equipment noise intensity, reference standard vibration frequency, allowable deviation vibration frequency, allowable deviation temperature, reference standard equipment energy consumption, allowable deviation equipment energy consumption, allowable deviation humidity, allowable deviation catalyst dosage, allowable deviation pH value, allowable deviation air pressure, allowable deviation stirring speed, reference standard humidity, reference standard catalyst dosage, reference standard pH value, reference standard air pressure, reference standard stirring speed, drug raw material generation quality assessment influencing factor corresponding to the set equipment status abnormal assessment value, drug raw material generation quality assessment influencing factor corresponding to the set production process stability assessment value, equipment status abnormal assessment threshold and drug raw material generation quality assessment threshold and other indicators.

[0072] The above contents are merely examples and explanations of the structure of the present invention. The technicians in this technical field 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 structure of the invention or exceed the scope defined by the present invention, they should all fall within the protection scope of the present invention.

Claims

1. A real-time monitoring method for a drug raw material production process, characterized in that: include: Monitor the drug raw material production process and collect reactant usage data, equipment status data and production process data; Processing the reactant usage data to obtain a reaction process evaluation index, matching the current reaction stage according to the reaction process evaluation index, and obtaining reference production process data for the current reaction stage; The equipment status data is processed to obtain the equipment status abnormality assessment value, the production process stability assessment value is obtained based on the reference production process data and the production process data, and the drug raw material generation quality assessment value is obtained through comprehensive analysis; The drug raw material production process is evaluated according to the drug raw material production quality evaluation value, and the evaluation results are obtained and fed back.

2. The real-time monitoring method for a drug raw material production process according to claim 1, characterized in that: The reactant usage data is processed to obtain the reaction progress evaluation index, and the specific processing process is as follows: The reactant usage data includes the concentration and water content of various reactants; The critical reactant concentration, allowable deviation water content and reference standard water content were extracted from the drug raw material database, and the reaction progress evaluation index was obtained through comprehensive analysis.

3. The real-time monitoring method for a pharmaceutical raw material production process according to claim 2, characterized in that: The current reaction stage is obtained by matching the reaction progress evaluation index, and the reference production process data of the current reaction stage is obtained. The specific matching process is: The reaction progress evaluation index is input into the drug raw material database to match the current reaction stage and the reference production process data of the current reaction stage, wherein the reference production process data of the current reaction stage includes the reference standard humidity, reference standard catalyst dosage, reference standard pH value, reference standard air pressure and reference standard stirring speed of the current reaction stage.

4. The real-time monitoring method for a pharmaceutical raw material production process according to claim 1, characterized in that: The device status data is processed to obtain the device status abnormality assessment value, and the specific processing process is as follows: The equipment status data includes the temperature of each temperature monitoring point, the pressure of each pressure monitoring point, the equipment noise intensity, the vibration frequency of each vibration monitoring point and the equipment energy consumption; The reference standard temperature, critical equipment noise intensity, reference standard vibration frequency, allowable deviation vibration frequency, allowable deviation temperature, reference standard equipment energy consumption and allowable deviation equipment energy consumption are extracted from the pharmaceutical raw material database, and a comprehensive analysis is performed to obtain the equipment status abnormality assessment value, and feedback is provided based on the equipment status abnormality assessment value.

5. The real-time monitoring method for a pharmaceutical raw material production process according to claim 1, characterized in that: The production process stability evaluation value is obtained by referring to the production process data and processing the production process data. The specific processing process is: The production process data includes humidity, catalyst dosage, pH value, air pressure and stirring speed at each time point in the reaction equipment; The allowable deviation of humidity, allowable deviation of catalyst dosage, allowable deviation of pH value, allowable deviation of air pressure and allowable deviation of stirring speed are extracted from the pharmaceutical raw material database, and the production process stability assessment value is obtained through comprehensive analysis.

6. A real-time monitoring method for a pharmaceutical raw material production process according to claim 5, characterized in that: The comprehensive analysis obtains the quality assessment value of the drug raw material, and the specific assessment process is as follows: According to the equipment status abnormality assessment value and the production process stability assessment value, a comprehensive analysis is performed to obtain a drug raw material production quality assessment value, which is used to quantitatively evaluate the quality of the drug raw material production process.

7. A real-time monitoring method for a pharmaceutical raw material production process according to claim 6, characterized in that: The pharmaceutical raw material production process is evaluated according to the pharmaceutical raw material production quality evaluation value, and the specific evaluation process is: The drug raw material generation quality assessment threshold is extracted from the drug raw material database, and the drug raw material generation quality assessment value is compared with the drug raw material generation quality assessment threshold. If the drug raw material generation quality assessment value is greater than or equal to the drug raw material generation quality assessment threshold, the drug raw material generation process is evaluated as qualified; if the drug raw material generation quality assessment value is less than the drug raw material generation quality assessment threshold, the drug raw material generation process is evaluated as unqualified.

8. The real-time monitoring method for a pharmaceutical raw material production process according to claim 4, characterized in that: The specific process of providing feedback based on the abnormal evaluation value of the device status is as follows: The equipment status abnormality assessment threshold is extracted from the drug raw material database. If the equipment status abnormality assessment value is greater than or equal to the equipment status abnormality assessment threshold, the drug raw material generation process is terminated immediately and an early warning is issued. If the equipment status abnormality assessment value is less than the equipment status abnormality assessment threshold, no additional operation is performed.

9. The real-time monitoring method for a pharmaceutical raw material production process according to claim 4, characterized in that: The specific numerical expression of the abnormal equipment status evaluation value is: ； in, represents the abnormal evaluation value of the equipment status, e represents the natural constant, represents the temperature of the ith temperature monitoring point, Indicates the reference standard temperature, Indicates the allowable deviation temperature, represents the pressure at the jth pressure monitoring point, Indicates the noise intensity of the device. represents the critical equipment noise intensity, represents the vibration frequency of the kth vibration monitoring point, Indicates the reference standard vibration frequency, Indicates the allowable deviation vibration frequency, Indicates the energy consumption of the device. Indicates the energy consumption of reference standard equipment, Indicates the allowable deviation of equipment energy consumption, Indicates the impact factor of the equipment status abnormality assessment corresponding to the set temperature. Indicates the impact factor of equipment status abnormality assessment corresponding to the set pressure, Indicates the equipment status abnormality assessment impact factor corresponding to the set equipment noise intensity, Indicates the equipment status abnormality assessment impact factor corresponding to the set vibration frequency. It represents the equipment status abnormality assessment impact factor corresponding to the set equipment energy consumption, i represents the number of each temperature monitoring point, i=1,2,3,...,m, m represents the total number of temperature monitoring points, j represents the number of each pressure monitoring point, j=1,2,3,...,n, n represents the total number of pressure monitoring points, k represents the number of each vibration monitoring point, k=1,2,3,...,s, s represents the total number of vibration monitoring points.

10. A system using a real-time monitoring method for a pharmaceutical raw material production process as claimed in any one of claims 1 to 9, characterized in that: include: Drug data collection module, used to monitor the drug raw material production process, collect reactant usage data, equipment status data and production process data; A reaction stage matching module is used to process the reactant usage data to obtain a reaction process evaluation index, match the current reaction stage according to the reaction process evaluation index, and obtain reference production process data for the current reaction stage; The drug raw material generation quality analysis module is used to process the equipment status data to obtain the equipment status abnormality assessment value, obtain the production process stability assessment value based on the reference production process data and the production process data, and obtain the drug raw material generation quality assessment value through comprehensive analysis; A drug raw material production process evaluation module is used to evaluate the drug raw material production process according to the drug raw material production quality evaluation value, obtain the evaluation results and provide feedback; The drug raw material database is used to store drug raw material related data, including: critical reactant concentration, allowable deviation water content, reference standard water content, reference standard temperature, critical equipment noise intensity, reference standard vibration frequency, allowable deviation vibration frequency, allowable deviation temperature, reference standard equipment energy consumption, allowable deviation equipment energy consumption, allowable deviation humidity, allowable deviation catalyst dosage, allowable deviation pH value, allowable deviation air pressure, allowable deviation stirring speed, reference standard humidity, reference standard catalyst dosage, reference standard pH value, reference standard air pressure, reference standard stirring speed, drug raw material generation quality assessment influencing factor corresponding to the set equipment status abnormality assessment value, drug raw material generation quality assessment influencing factor corresponding to the set production process stability assessment value, equipment status abnormality assessment threshold and drug raw material generation quality assessment threshold.

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