Pioglitazone hydrochloride drug production environment monitoring and early warning method and system

Abstract

The invention discloses a pioglitazone hydrochloride drug production environment monitoring and early warning method and system, and relates to the technical field of drug production environment monitoring. Comprising the following steps: collecting microbial samples in a production place, constructing a plurality of culture media according to the types of the microbial samples, obtaining environmental data of the production place in a current time period, including the concentration, humidity and temperature of a pioglitazone hydrochloride drug, and simulating an ecological environment outside different culture media based on the environmental data to reflect an actual production environment of the production place. According to the present invention, by collecting the microorganism sample of the production site and combining the environmental data (such as the pioglitazone hydrochloride drug concentration, the humidity and the temperature) of the current time period, the actual condition of the production environment can be accurately reflected, and by simulating the ecological environment and associating the biological characteristic data with the environmental data, the real-time monitoring of the production environment can be achieved. And real-time monitoring of microbial activity in a production environment is realized, so that potential safety hazards caused by a production place to organisms are monitored from the side.

Description

Technical Field

[0001] The present invention relates to the technical field of drug production environment monitoring, and in particular to a method and system for early warning of the drug production environment of pioglitazone hydrochloride. Background Art

[0002] Pioglitazone hydrochloride is an anti-diabetic drug. In the actual preparation process, the production environment needs to be monitored and warned to ensure the quality of the finished product. Therefore, it is necessary to design a pioglitazone hydrochloride drug production environment monitoring and early warning method and system.

[0003] After searching, the Chinese invention patent with publication number "CN114034826A" discloses "a production environment monitoring system for freeze-dried bird's nest process based on data analysis". This application analyzes the preparation efficiency of the freeze-dried bird's nest process to determine whether the freeze-dried bird's nest process is qualified, and at the same time provides monitoring standards for production environment monitoring, thereby improving the accuracy and efficiency of freeze-dried bird's nest monitoring; effectively collects the qualified parameter threshold range of the current environment through actual products, effectively improves the accuracy of production environment monitoring, and prevents errors in environmental parameters, which leads to reduced process production efficiency and increased product unqualified rate; analyzes the production environment of the monitored product to determine whether the regional environment is within the threshold range of the monitored product, accurately monitors the production of the monitored product, prevents environmental anomalies from causing abnormal production of the monitored product, and reduces the qualified rate of the monitored product, thereby reducing the efficiency of the corresponding process of the monitored product and indirectly affecting product production; analyzes unqualified products, and analyzes the parameters that affect the product through unqualified product analysis, thereby preventing product production and improving product qualified rate.

[0004] In addition, the Chinese invention patent with publication number "CN112986157A" discloses "a method, device and system for early warning and control of aquaculture water environment". This application uses UAV hyperspectral remote sensing technology to invert water quality parameters through hyperspectral images, and combines conventional methods to sample water quality parameters, which opens up a new way for aquaculture water environment water quality monitoring and aquaculture water environment regulation, and is also beneficial to the protection of freshwater fishery aquaculture water environment.

[0005] However, when the above two disclosed methods and similar methods monitor the environment, since the environment may contain product ingredients or chemical components for processing, these may cause the operator to experience physical abnormalities due to inhalation during actual operation. Therefore, the applicant proposes a method and system for real-time monitoring and early warning of the production environment by detecting biometric data in microorganisms in the environment. Summary of the invention

[0006] The object of the present invention is to provide a method and system for monitoring and early warning of the production environment of pioglitazone hydrochloride medicine, so as to solve the problems raised in the above-mentioned background technology.

[0007] In a first aspect, to achieve the above-mentioned purpose, the present invention provides the following technical solutions: a method for monitoring and early warning of the production environment of pioglitazone hydrochloride, comprising: collecting microbial samples at the production site, and constructing multiple culture media according to the types of microbial samples;

[0008] Obtain environmental data for the current time period at the production site, including pioglitazone hydrochloride drug concentration, humidity, and temperature;

[0009] Based on environmental data, simulate the ecological environment outside different culture media to reflect the actual production environment of the production site;

[0010] Obtain two microbial samples from any culture medium;

[0011] Associating the biometric data of the two microbial samples with the environmental data outside the corresponding culture medium, and outputting the association result, the biometric data including activity data and gene sequence data;

[0012] According to the correlation results, the factors affecting the biometric data of the microbial samples are determined;

[0013] Combine influencing factors and environmental data to obtain early warning environmental data thresholds;

[0014] Compare the warning environment data threshold with the environment data of the current time period and output the comparison result;

[0015] According to the comparison results, an early warning signal for the production environment monitoring of pioglitazone hydrochloride drug is output.

[0016] As a further preferred embodiment of the present technical solution, the production site is provided with multiple production spaces, the microbial samples cultured in each culture medium come from different production spaces, the same type of microbial samples in any two culture media are obtained, the difference value of environmental data under the same biological characteristic data of the two microbial samples is obtained, the influence coefficient of different production spaces on the growth conditions of the microbial samples is obtained based on the environmental data difference value, and the ecological environment is adjusted based on the influence coefficient.

[0017] As a further preferred embodiment of the present technical solution, the method for constructing multiple culture media according to the types of microbial samples includes:

[0018] The biometric data of the microbial sample is obtained, the component data of the culture medium is adjusted based on the biometric data, and the range of the component data is limited based on the type of the microbial sample to ensure that a single type of microbial sample can be cultured in the culture medium.

[0019] As a further preferred embodiment of the present technical solution, a method for obtaining the association result includes:

[0020] Obtaining biometric data of a first microbial sample, the first microbial sample being the microbial sample that has taken up the most pioglitazone hydrochloride in all culture media, and obtaining biometric data of a second microbial sample, the second microbial sample being the microbial sample that has taken up the most biometric data in all culture media;

[0021] Acquire biometric data of the first microbial sample and the second microbial sample at different time points in the current time period, and map them into a two-dimensional graph to form a first fitting line segment and a second fitting line segment, wherein the x-axis in the two-dimensional graph represents the time point and the y-axis represents the biometric data value;

[0022] Based on the association method, the coincidence position of the first fitting line segment and the second fitting line segment is obtained, and the association result is output.

[0023] As a further preferred embodiment of the present technical solution, the association method also includes: respectively obtaining the slopes of the first fitting line segment and the second fitting line segment, and outputting an association result based on the average value of the slopes of the first fitting line segment and the second fitting line segment, wherein the association result is used to represent the rate of change of the biometric data of the microbial sample.

[0024] As a further preferred embodiment of the present technical solution, a method for determining influencing factors affecting biometric data of microbial samples according to association results is as follows: obtaining associated microbial samples in culture medium based on the association results, obtaining gene sequence data of the associated microbial samples, comparing the gene sequence data of any two associated microbial samples in all culture mediums, and outputting multiple sets of difference sequence data, integrating and arranging the multiple sets of difference sequence data, and forming influencing factors.

[0025] As a further preferred embodiment of the present technical solution, a method for obtaining a warning environmental data threshold by combining influencing factors and environmental data includes:

[0026] Based on the impact factor, reverse search is performed to locate the microbial samples in the culture medium;

[0027] Obtain the variation range of the difference sequence data values ​​of the microbial samples at different time points in the current time period;

[0028] Mark the specific time points of the environmental data in the current time period based on the characteristic points of the change amplitude;

[0029] Obtain the value of the environmental data at a specific time point as the subset data threshold;

[0030] Associate the subset data thresholds in different culture media and form the early warning environment data thresholds.

[0031] In the second aspect, in order to improve the above technical solution, the present invention also proposes a pioglitazone hydrochloride drug production environment monitoring and early warning system, which uses the above pioglitazone hydrochloride drug production environment monitoring and early warning method and includes:

[0032] A data collection module is used to collect microbial samples at the production site and obtain environmental data for the current time period;

[0033] The culture medium construction and simulation module is used to construct multiple culture media according to the types of collected microbial samples and simulate the ecological environment outside different culture media;

[0034] A data association and analysis module, used to associate the biometric data of the microbial sample with the environmental data outside the corresponding culture medium, and output the association result;

[0035] An influencing factor determination module determines influencing factors affecting the biometric data of the microbial sample based on the correlation results;

[0036] The culture medium construction and simulation module sets the warning environmental data threshold based on influencing factors and environmental data;

[0037] The warning signal output module is used to output a warning signal according to the comparison result.

[0038] As a further preferred embodiment of the present technical solution, the data acquisition module is composed of a plurality of sensors of different types, and the sensors are used for real-time monitoring of the pioglitazone hydrochloride drug concentration, humidity and temperature at the production site.

[0039] Compared with the prior art, the present invention has the following beneficial effects:

[0040] The pioglitazone hydrochloride drug production environment monitoring and early warning method and system can more accurately reflect the actual situation of the production environment by collecting microbial samples from the production site and combining them with environmental data of the current time period (such as pioglitazone hydrochloride drug concentration, humidity and temperature). By simulating the ecological environment and correlating biological characteristic data with environmental data, real-time monitoring of microbial activities in the production environment is achieved, thereby indirectly monitoring the potential safety hazards caused by the production site to organisms.

[0041] In addition, by determining the influencing factors that affect the biometric data of microbial samples and combining environmental data to obtain the warning environmental data threshold, a more sensitive early warning system can be built. When the data in the production environment exceeds the warning threshold, the system will promptly output a monitoring early warning signal to remind production personnel to take corresponding measures, thereby effectively avoiding the occurrence of production accidents. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1A step diagram of the pioglitazone hydrochloride drug production environment monitoring and early warning method of the present invention;

[0043] Figure 2 A two-dimensional graph of biological characteristic data of the first microorganism sample and the second microorganism sample at different time points in the current time period of the present invention;

[0044] Figure 3 A comparison diagram of the gene sequences of two related microorganisms in a single culture medium of the present invention;

[0045] Figure 4 The present invention is a module composition diagram of the pioglitazone hydrochloride drug production environment monitoring and early warning system. DETAILED DESCRIPTION

[0046] 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.

[0047] Before understanding the present invention, it should be clear that since pioglitazone hydrochloride is an anti-diabetic drug, when the pioglitazone hydrochloride drug content in the production environment is too high, it will cause a series of adverse reactions to the operator, and in severe cases it will also cause health problems for the workers in the production environment. Therefore, the present invention proposes a pioglitazone hydrochloride drug production environment monitoring and early warning method to solve the problems arising in the above scenario.

[0048] It should be understood that before the method disclosed in the present invention is run, it is necessary to collect microbial samples at the production site of the pioglitazone hydrochloride drug and construct multiple culture media based on the types of microbial samples. In the present invention, the microbial samples obtained are microorganisms floating in the air. In addition, when actually collecting microbial samples, there are many types of microorganisms floating in the air environment. Therefore, the method of constructing multiple culture media based on the types of microbial samples includes: steps S001-S003.

[0049] Specifically, step S001: obtaining biometric data of a microbial sample.

[0050] It should be clear that in the present invention, biometric data includes: activity data and gene sequence data, wherein the activity data and gene sequence data are obtained by respectively using the fluorescent labeling technology and gene sequencing technology in the prior art.

[0051] Specifically, the fluorescent labeling technology is to label the target object with a specific fluorescent dye or fluorescent probe, and then use the fluorescent signal to detect and analyze the activity state of the target object. The principle of the fluorescent labeling technology is based on the characteristics of fluorescent substances. After being irradiated with excitation light, the fluorescent substance will absorb the energy of the excitation light and transition to a high energy level state, and then return to a low energy level state and release a fluorescent signal. This fluorescent signal can be captured by the detector and converted into an electrical signal, and then recorded and analyzed. Specifically in the scenario of obtaining activity data in the present invention, first, a specific fluorescent dye or fluorescent probe is mixed with a microbial sample to ensure that the target microorganism is labeled. Then, an excitation light source is used to irradiate the mixed sample to excite the fluorescent substance. Under the action of the excitation light, the labeled microorganism will emit a fluorescent signal. The intensity of these signals is related to the activity state of the microorganism. These signals are collected by the detector and converted into electrical signals. The electrical signals are then recorded and analyzed to obtain quantitative data of microbial activity. It should be noted that in the present invention, the fluorescent dye can be fluorescein isothiocyanate, and fluorescein isothiocyanate can specifically bind to molecules on the surface of microbial cells or internal biological molecules.

[0052] Specifically, gene sequencing technology is to determine the type and characteristics of microbial samples by analyzing the gene sequence of the samples. It should be added that gene sequencing technology identifies the gene sequence of specific microorganisms by separating and analyzing DNA fragments. In the present invention, the implementation of gene sequencing technology includes the following steps: first, extract DNA from the microbial sample, then amplify the extracted DNA fragments so that there is a sufficient amount for sequencing, and then use a high-throughput sequencing platform to sequence the DNA fragments to generate a large number of short sequence reads. Finally, these short sequence reads are spliced ​​into a complete gene sequence through bioinformatics tools, and compared with a known microbial gene database to identify the type of microorganism in the sample. In this way, multiple culture media for monitoring the production environment of pioglitazone hydrochloride are accurately constructed, providing a basis for subsequent monitoring and early warning. The bioinformatics tool is a BLAST (Basic Local Alignment Search Tool) tool in the prior art, which can quickly compare sequences and find the known microbial gene sequence that is most similar to the sample sequence.

[0053] Step S002: Adjusting the composition data of the culture medium based on the biometric data.

[0054] It should be clear that in the present invention, the method of adjusting the composition data of the culture medium based on biometric data is to screen out the nutrients required for the growth of microorganisms based on the gene sequence data of the microbial sample, and determine the concentration of the nutrients in the culture medium according to the activity data. For example, if the activity data shows that a certain microorganism has a higher demand for a specific nutrient, the content of the nutrient in the culture medium is increased accordingly.

[0055] Step S003: limiting the scope of component data based on the type of microbial sample.

[0056] It should be clear that step S003 is used to ensure that a single type of microbial sample can be cultured in the culture medium.

[0057] Specifically, during the actual implementation of step S003, by analyzing the type information of the microbial sample, the specific nutrients required for the growth of the type of microorganism are identified, and then, based on these specific nutrients, the composition data of the culture medium is adjusted to exclude nutrients used by other types of microorganisms, thereby limiting the range of the culture medium composition data. In this way, it can be ensured that the culture medium is only suitable for the growth of the target microbial sample, while inhibiting the growth of other non-target microorganisms, thereby achieving the cultivation of specific microbial species.

[0058] refer to Figure 1 It can be seen that the pioglitazone hydrochloride drug production environment monitoring and early warning method includes: steps S100 to S800.

[0059] Step S100: Acquire environmental data of the production site in the current time period.

[0060] It should be understood that in the present invention, environmental data include: pioglitazone hydrochloride drug concentration, humidity and temperature.

[0061] Specifically, in the present invention, the drug concentration of pioglitazone hydrochloride, the humidity of production, and the temperature of the production site in the environmental data are collected by using different types of sensors, which are pioglitazone hydrochloride concentration sensors, humidity sensors, and temperature sensors. The pioglitazone hydrochloride concentration sensor can detect the concentration change of the drug during the production process to ensure that the drug concentration remains within a safe and effective range. The humidity sensor is responsible for monitoring the humidity level of the production environment to prevent excessive or low humidity from affecting the stability and quality of the drug. The temperature sensor continuously monitors the temperature of the production site to ensure that production is carried out within the specified temperature range to avoid drug quality problems caused by temperature fluctuations.

[0062] In addition, it should be added that in actual operation, the production site is set up with multiple production spaces, and the microbial samples cultured in each culture medium come from different production spaces. The same type of microbial samples in any two culture media are obtained, and the difference in environmental data under the same biological characteristic data of the two microbial samples is obtained. Based on the difference in environmental data, the influence coefficient of different production spaces on the growth conditions of microbial samples is obtained, and the ecological environment is adjusted based on the influence coefficient.

[0063] It should be noted that this operation is used to optimize and control the production environment to ensure that the growth conditions of the microbial samples match specific environmental parameters. In this way, the ideal environment required for microbial growth during the production process can be accurately simulated and maintained, thereby improving the quality and efficiency of drug production. In addition, by monitoring and adjusting environmental parameters, problems that arise during the production process, such as microbial contamination or deviations in growth conditions, can be discovered and resolved in a timely manner, ensuring the stability of the production process and the safety of the final product.

[0064] Step S200: simulating an ecological environment outside different culture media based on environmental data.

[0065] It should be clear that step S200 is used to reflect the actual production environment of the production site. During actual operation, the actual operation method of step S200 includes: step S210-step S220.

[0066] Specifically, step S210: setting simulation parameters according to environmental data. In step S210, based on the environmental data obtained from the production site (including pioglitazone hydrochloride drug concentration, humidity and temperature), the parameters of the simulated ecological environment are manually set. These parameters will accurately reflect the conditions of the actual production environment and ensure that the simulated ecological environment is consistent with the actual environment.

[0067] For example, if the actual production environment has a drug concentration of pioglitazone hydrochloride of X mg / m 3 , humidity is Y%, and temperature is Z℃, then in the simulated ecosystem, these parameters are adjusted accordingly to match the actual environment.

[0068] Step S220: Place the simulated culture medium in a simulated ecological environment to simulate the impact of the actual production environment on the growth of microorganisms. In step S220, place the culture medium with adjusted component data in a simulated ecological environment to simulate the pioglitazone hydrochloride drug concentration, humidity and temperature conditions in the actual production environment, and observe and record the growth of microorganisms under these conditions. In this way, the growth status and activity of microorganisms under different environmental conditions are evaluated to provide data support for subsequent monitoring and early warning.

[0069] Step S300: Obtain two microorganism samples from any culture medium.

[0070] It should be noted that the two microorganism samples in any culture medium in step S300 are microorganism samples of the same type.

[0071] Step S400: Associating the biological characteristic data of the two microorganism samples with the environmental data outside the corresponding culture medium, and outputting the association result.

[0072] It should be clear that in the present invention, biometric data includes activity data and gene sequence data.

[0073] It should be further supplemented that the method for obtaining the association result in step S400 includes: step S410 to step S440.

[0074] Specifically, step S410: obtaining the biometric data of the first microorganism sample. It should be noted that the first microorganism sample is the microorganism sample that absorbs the most pioglitazone hydrochloride in all culture media.

[0075] Step S420: Obtaining biometric data of the second microorganism sample. It should be noted that the second microorganism sample is the microorganism sample with the most biometric data in all culture media.

[0076] Step S430: Obtain the biometric data of the first microbial sample and the second microbial sample at different time points in the current time period, and map them into a two-dimensional graph respectively, referring to Figure 2 It can be seen that a first fitting line segment and a second fitting line segment are formed in the two-dimensional graph. It should be clear that the x-axis in the two-dimensional graph represents the time point, and the y-axis represents the biometric data value.

[0077] Step S440: Based on the association method, obtain the overlapping position of the first fitting line segment and the second fitting line segment, and output the association result.

[0078] It should be noted that in the method for obtaining the association result of the present invention, the two-dimensional graph is constructed by a computer mapping program in the prior art after receiving the biometric data and by associating the time points of the acquired biometric data. The association method in step S440 is that the computer mapping program scans the first fitting line segment and the second fitting line segment respectively, and obtains the coincidence point between the first fitting line segment and the second fitting line segment. It should be emphasized that in the present invention, the coincidence point between the first fitting line segment and the second fitting line segment is used to represent the correlation between the pioglitazone hydrochloride drug content and the biometric data under the same environment.

[0079] As an implementation method of step S440, during actual operation, another implementation of the association method also includes: respectively obtaining the slopes of the first fitting line segment and the second fitting line segment, and outputting the association result based on the average value of the slopes of the first fitting line segment and the second fitting line segment, wherein the association result is used to represent the rate of change of the biometric data of the microbial sample. It should be noted that in another implementation of the association method, the computer provides a more in-depth correlation analysis by analyzing the shapes, slope changes and relative positions of the first fitting line segment and the second fitting line segment. For example, by comparing the curvatures of the two fitting line segments, it can be inferred whether the microbial samples respond consistently to the pioglitazone hydrochloride drug at different time points, and whether the changing trend of the biometric data matches the changing trend of the drug content. In addition, by analyzing the fluctuations of the fitting line segments, the adaptability and stability of the microbial samples under different environmental conditions can be further understood.

[0080] Step S500: Determine the influencing factors affecting the biometric data of the microbial sample according to the association result.

[0081] It should be clear that step S500 is used to evaluate the adaptability of the microbial sample and its sensitivity to environmental changes. By analyzing the growth status and activity of the microbial sample under different environmental conditions, it is identified which environmental factors have a significant effect on the growth and activity of the microorganism. For example, if it is found that the microbial sample grows actively at a specific pioglitazone hydrochloride drug concentration, but grows slowly or stops at another concentration, then it is inferred that the drug concentration is a key factor affecting the growth of the microorganism. Similarly, changes in humidity and temperature will also affect the growth of microorganisms. By comparing the microbial growth data under different humidity and temperature conditions, the specific effects of these environmental factors on the growth of microorganisms are determined. Through these analyses, a scientific basis is provided for environmental control in the production process to ensure the stability of the production environment and the quality of microbial products.

[0082] It should be further explained that, according to the association result, the method for determining the influencing factors affecting the biometric data of the microbial sample includes: step S510 to step S540.

[0083] Specifically, step S510: obtaining associated microorganism samples in the culture medium based on the associated results.

[0084] It should be clear that step S510 is used to determine other microbial samples in the culture medium that have similar biometric data to the associated microbial sample. This step is achieved by comparing the similarity of the biometric data, for example, by calculating the similarity of gene sequence data or the similarity of activity data, thereby identifying other microbial samples that have high similarity in biometrics to the associated microbial sample. In this way, the growth and activity responses of these microbial samples under different environmental conditions, as well as their adaptability to environmental changes, are further studied.

[0085] Specifically, in step S440 and the implementation method of step S440, the association result represents the effect of the pioglitazone hydrochloride drug on the biometric data (activity) of the microbial sample, and the law of change of the biometric data of the remaining microbial samples in the culture medium (i.e., excluding the first microbial sample and the second microbial sample) over time is retrieved by reading the time point of the overlap point, the biometric data value or the slope of the first microbial sample and the second microbial sample. It should be supplemented that, in actual operation, the microorganisms in the production site are introduced into the culture medium, and the biometric data at different time points in the current time period are obtained, and finally mapped into a two-dimensional graph, and the associated microbial samples corresponding to the association result are obtained through computer analysis.

[0086] Step S520: Obtain gene sequence data of the associated microbial sample.

[0087] Step S530: compare the gene sequence data of any two related microbial samples in all culture media, and output multiple groups of difference sequence data.

[0088] It should be noted that since the two related microbial samples in a single culture medium are samples of the same type, when comparing gene sequence data, the BLAST or Smith-Waterman algorithm is used for comparison, and the differences are marked. For details, refer to Figure 3 It is knowable.

[0089] Step S540: Integrate and arrange multiple sets of difference sequence data and form impact factors.

[0090] It should be clear that step S540 is used to construct a feature database of microbial samples. By integrating the multiple sets of differential sequence data obtained in step S530 according to the types of microbial samples, a database containing the characteristics of all relevant microbial samples is created. It should be noted that the establishment of the database can help identify potential connections and differences between microbial samples, and provide a powerful tool for microbial classification and evolutionary research. For example, by comparing the differences in gene sequences of different microbial samples, the relationship between them can be inferred, thereby providing data support for phylogenetic research on microorganisms.

[0091] In addition, it should be noted that the impact factor is a sequence data set in the feature database, and the sequence data set contains all differential sequence data at the same time point.

[0092] Step S600: Acquire a warning environmental data threshold by combining the influencing factors and environmental data.

[0093] It should be clear that the method for obtaining the early warning environmental data threshold by combining the influencing factors and the environmental data includes: step S610 to step S650.

[0094] Specifically, step S610: based on the influencing factors, reverse search and locate the microbial sample in the culture medium.

[0095] It should be noted that, in actual operation, step S610 is implemented by comparing the sequence data set in the influencing factor with the gene sequence data of the microbial sample in the culture medium. When the similarity between the two is 80% or above, it is determined to be the microbial sample to be retrieved.

[0096] Step S620: Obtain the variation range of the difference sequence data values ​​of the microbial sample at different time points in the current time period.

[0097] It should be noted that, during the actual operation of step S620, the adaptability and stability of the microbial sample under different environmental conditions are evaluated by analyzing the amplitude of the variation. For example, if the variation amplitude of the gene sequence data value of the microbial sample under specific environmental conditions is small, it indicates that the microbial sample has a strong adaptability to these conditions. On the contrary, if the variation amplitude is large, it means that the microbial sample is more sensitive to these conditions and requires further environmental adjustment to ensure its normal growth and activity.

[0098] Step S630: Mark the specific time points of the environmental data in the current time period based on the feature points of the change amplitude.

[0099] It should be noted that the characteristic points in step S630 are points where a high increase or decrease occurs in the amplitude of change, and the specific time points represent turning points in the scenario. These turning points indicate the critical state of microbial growth or the sensitivity to environmental changes. By identifying these specific time points, reference data is provided for the environmental monitoring and early warning system, so that measures can be taken before abnormal microbial growth occurs, ensuring the smooth progress of the production process and the stability of product quality.

[0100] Step S640: Obtain the value of the environmental data at a specific time point as a subset data threshold.

[0101] Step S650: Associating subset data thresholds in different culture media and forming early warning environment data thresholds.

[0102] It should be noted that in step S640 and step S650, obtaining the numerical value of the environmental data at a specific time point and associating the subset data thresholds in different culture media are completed by extracting and summarizing the existing computer data, among which the subset data thresholds in different culture media are associated mainly by the accumulation data processing method.

[0103] Step S700: Compare the warning environment data threshold with the environment data of the current time period and output the comparison result.

[0104] It should be clear that step S700 is used to evaluate whether the current environmental conditions are suitable for the growth and activity maintenance of microbial samples. The specific operation is to compare and analyze the warning environmental data threshold with the real-time monitored environmental data, perform automated comparison and analysis processing through computer software, and output the comparison results.

[0105] Step S800: outputting a pioglitazone hydrochloride drug production environment monitoring early warning signal according to the comparison result.

[0106] It should be understood that during the actual operation of step S800, if the comparison result shows that the environmental conditions are not suitable, the system will issue a warning signal to prompt the operator to adjust the environmental parameters, such as temperature, humidity and pH value, to ensure the normal growth and activity of the microbial sample.

[0107] It should be added that the output form of the early warning signal can be a visual alarm, an audible alarm or an electronic alarm sent through the network so that timely measures can be taken.

[0108] refer to Figure 4 It can be seen that in order to improve the above-mentioned disclosed pioglitazone hydrochloride drug production environment monitoring and early warning method, the present invention also proposes a pioglitazone hydrochloride drug production environment monitoring and early warning system. It should be noted that the pioglitazone hydrochloride drug production environment monitoring and early warning system uses the above-mentioned pioglitazone hydrochloride drug production environment monitoring and early warning method, and includes: a data acquisition module, which is used to collect microbial samples at the production site and obtain environmental data of the current time period, a culture medium construction and simulation module, which is used to construct multiple culture media according to the types of collected microbial samples, and simulate the ecological environment outside different culture media, a data association and analysis module, which is used to associate the biometric data of the microbial sample with the environmental data outside the corresponding culture medium, and output the association result, an influencing factor determination module, which determines the influencing factors affecting the biometric data of the microbial sample based on the association result, an early warning environment data threshold setting module, which sets the early warning environment data threshold based on the influencing factor and environmental data, and an early warning signal output module, which is used to output an early warning signal according to the comparison result.

[0109] It should be pointed out that during actual operation, all modules in the pioglitazone hydrochloride drug production environment monitoring and early warning system work collaboratively with each other to form a closed-loop feedback mechanism.

[0110] Specifically, the data acquisition module first collects the required microbial samples and environmental data, and then passes these data to the culture medium construction and simulation module. The culture medium construction and simulation module designs specific culture media based on the sample data and simulates a variety of ecological environments to observe the growth of microorganisms under different conditions. Then the data association and analysis module conducts a comprehensive analysis of the biometric data of the microbial samples and the simulated environmental data to identify the key environmental factors that affect the growth of microorganisms. The influencing factor determination module further confirms the key influencing factors that affect the biological characteristics of microorganisms based on the results of the association analysis. The early warning environmental data threshold setting module uses these influencing factors and environmental data to set the early warning threshold to ensure that the early warning can be issued in time when the environmental data deviates from the normal range. Finally, the early warning signal output module compares the real-time monitoring data according to the set threshold. Once an abnormality is detected, an early warning signal is immediately issued to prompt the operator to take corresponding measures. The entire system ensures the stability and safety of the pioglitazone hydrochloride drug production environment through the interaction between modules.

[0111] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. The pioglitazone hydrochloride drug production environment monitoring and early warning method includes: Microbial samples are collected at the production site of pioglitazone hydrochloride, and multiple culture media are constructed based on the types of microbial samples, characterized in that: Obtain environmental data for the current time period at the production site, including pioglitazone hydrochloride drug concentration, humidity, and temperature; Based on environmental data, simulate the ecological environment outside different culture media to reflect the actual production environment of the production site; Obtain two microbial samples from any culture medium; Associating the biometric data of the two microbial samples with the environmental data outside the corresponding culture medium, and outputting the association result, the biometric data including activity data and gene sequence data; According to the correlation results, the factors affecting the biometric data of the microbial samples are determined; Combine influencing factors and environmental data to obtain early warning environmental data thresholds; Compare the warning environment data threshold with the environment data of the current time period and output the comparison result; According to the comparison results, an early warning signal for the production environment monitoring of pioglitazone hydrochloride drug is output.

2. The method for monitoring and early warning of the pioglitazone hydrochloride drug production environment according to claim 1, characterized in that: The production site is equipped with multiple production spaces. The microbial samples cultured in each culture medium come from different production spaces. The same type of microbial samples in any two culture media are obtained, and the difference value of environmental data under the same biological characteristic data of the two microbial samples is obtained. Based on the difference value of environmental data, the influence coefficient of different production spaces on the growth conditions of microbial samples is obtained, and the ecological environment is adjusted based on the influence coefficient.

3. The method for monitoring and early warning of the pioglitazone hydrochloride drug production environment according to claim 1, characterized in that: Methods for constructing multiple culture media based on the types of microbial samples include: The biometric data of the microbial sample is obtained, the component data of the culture medium is adjusted based on the biometric data, and the range of the component data is limited based on the type of the microbial sample to ensure that a single type of microbial sample can be cultured in the culture medium.

4. The method for monitoring and early warning of pioglitazone hydrochloride drug production environment according to claim 1, characterized in that: Methods for obtaining association results include: Obtaining biometric data of a first microbial sample, the first microbial sample being the microbial sample that has taken up the most pioglitazone hydrochloride in all culture media, and obtaining biometric data of a second microbial sample, the second microbial sample being the microbial sample that has taken up the most biometric data in all culture media; Acquire biometric data of the first microbial sample and the second microbial sample at different time points in the current time period, and map them into a two-dimensional graph to form a first fitting line segment and a second fitting line segment, wherein the x-axis in the two-dimensional graph represents the time point and the y-axis represents the biometric data value; Based on the association method, the coincidence position of the first fitting line segment and the second fitting line segment is obtained, and the association result is output.

5. The method for monitoring and early warning of the pioglitazone hydrochloride drug production environment according to claim 4, characterized in that: The association method also includes: respectively obtaining the slopes of the first fitting line segment and the second fitting line segment, and outputting an association result based on the average value of the slopes of the first fitting line segment and the second fitting line segment, wherein the association result is used to represent the rate of change of the biometric data of the microbial sample.

6. The method for monitoring and early warning of pioglitazone hydrochloride drug production environment according to claim 1, characterized in that: A method for determining factors affecting biometric data of microbial samples based on association results: obtaining associated microbial samples in culture medium based on the association results, obtaining gene sequence data of associated microbial samples, comparing gene sequence data of any two associated microbial samples in all culture mediums, and outputting multiple sets of differential sequence data, integrating and arranging the multiple sets of differential sequence data, and forming influencing factors.

7. The method for monitoring and early warning of the pioglitazone hydrochloride drug production environment according to claim 1, characterized in that: Combining influencing factors and environmental data, the methods for obtaining early warning environmental data thresholds include: Based on the impact factor, reverse search is performed to locate the microbial samples in the culture medium; Obtain the variation range of the difference sequence data values ​​of the microbial samples at different time points in the current time period; Mark the specific time points of the environmental data in the current time period based on the characteristic points of the change amplitude; Obtain the value of the environmental data at a specific time point as the subset data threshold; Associate the subset data thresholds in different culture media and form the early warning environment data thresholds.

8. A pioglitazone hydrochloride drug production environment monitoring and early warning system, using the pioglitazone hydrochloride drug production environment monitoring and early warning method according to any one of claims 1 to 7, characterized in that: include: A data collection module is used to collect microbial samples at the production site and obtain environmental data for the current time period; The culture medium construction and simulation module is used to construct multiple culture media according to the types of collected microbial samples and simulate the ecological environment outside different culture media; A data association and analysis module, used to associate the biometric data of the microbial sample with the environmental data outside the corresponding culture medium, and output the association result; An influencing factor determination module determines influencing factors affecting the biometric data of the microbial sample based on the correlation results; The warning environment data threshold setting module sets the warning environment data threshold based on the influencing factors and environmental data; The warning signal output module is used to output a warning signal according to the comparison result.

9. The pioglitazone hydrochloride drug production environment monitoring and early warning system according to claim 8, characterized in that: The data acquisition module is composed of a plurality of sensors of different types, and the sensors are used to monitor the drug concentration, humidity and temperature of pioglitazone hydrochloride in the production site in real time.

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