Method for detecting and evaluating dissolution consistency of compound liquorice tablets

Abstract

The invention relates to the field of medicine analysis, and discloses a method and a system for detecting and evaluating dissolution consistency of compound liquorice tablets, and the method comprises the following steps: constructing a dynamic dissolution environment of the compound liquorice tablets; extracting a sample liquid of the dissolved solution; determining the dissolution amount of the sample liquid, and constructing a dissolution curve of the sample liquid; detecting a standard chromatogram of the standard control solution, and calculating the component content similarity of the sample liquid and the standard control solution; calculating macro qualitative similarity and macro quantitative similarity of the sample liquid and the standard control solution, analyzing ultraviolet fingerprint similarity of the standard ultraviolet fingerprint and the sample ultraviolet fingerprint, and executing dissolution consistency detection treatment of the sample liquid and the standard control solution; according to the method, the accuracy of compound liquorice tablet dissolution consistency detection and evaluation can be improved.

Description

Technical Field

[0001] The present invention relates to the field of pharmaceutical analysis, and particularly to a method and system for detecting and evaluating the dissolution consistency of compound liquorice tablets. Background Art

[0002] The dissolution consistency of compound liquorice tablets refers to the similarity of the rate and extent of the release of the active ingredients in compound liquorice tablets into the dissolution medium at different time points and under different conditions. Dissolution consistency is one of the key indicators for evaluating the quality of drugs. Through the detection and evaluation method, it can be ensured that the release of the active ingredients in compound liquorice tablets meets the established standards, thereby guaranteeing the efficacy and safety of the drugs.

[0003] Currently, the detection and evaluation method for drugs is chemical qualitative identification and detection of index components, mainly by identifying, inspecting, and determining the content of a certain chemical component of the drug. This method, which is a traditional method for evaluating the quality of traditional Chinese medicine by qualitatively and quantitatively analyzing a certain chemical component, cannot meet the requirements for comprehensively controlling the quality of preparations. Detecting any one active ingredient cannot reflect its overall efficacy, resulting in the detection and evaluation method being insufficiently comprehensive and accurate. Summary of the Invention

[0004] The present invention provides a method and system for detecting and evaluating the dissolution consistency of compound liquorice tablets, and its main purpose is to improve the accuracy of detecting and evaluating the dissolution consistency of compound liquorice tablets.

[0005] To achieve the above object, a method for detecting and evaluating the dissolution consistency of compound liquorice tablets provided by the present invention includes:

[0006] Analyze the main components and application scenarios of compound liquorice tablets, and based on the main components and the application scenarios, construct a dynamic dissolution environment for the compound liquorice tablets;

[0007] Based on the dynamic dissolution environment, perform a dissolution test on the compound liquorice tablets to obtain a dissolution solution, and extract a sample liquid from the dissolution solution;

[0008] Construct a chromatographic detection environment for the sample liquid, and based on the chromatographic detection environment, detect a sample chromatogram of the sample liquid. According to the sample chromatogram, determine the dissolution amount of the sample liquid, and based on the dissolution amount, construct a dissolution curve for the sample liquid;

[0009] Construct a standard reference solution for the sample liquid, and based on the liquid chromatography detection environment, detect a standard chromatogram of the standard reference solution. Use a preset chromatographic peak recognition algorithm to respectively identify the standard fingerprint peak area and the sample fingerprint peak area of the standard chromatogram and the sample chromatogram. According to the standard fingerprint peak area and the sample fingerprint peak area, calculate the similarity of the component contents between the sample liquid and the standard reference solution;

[0010] Analyze the standard dissolution curve of the standard reference solution. According to the dissolution curve and the standard dissolution curve, calculate the macro qualitative similarity and macro quantitative similarity between the sample liquid and the standard reference solution. Perform ultraviolet spectral detection on the standard reference solution and the sample liquid respectively to obtain a standard ultraviolet fingerprint spectrum and a sample ultraviolet fingerprint spectrum. Analyze the similarity of the ultraviolet fingerprint spectra of the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum. According to the macro qualitative similarity, the macro quantitative similarity, the similarity of component contents, and the similarity of ultraviolet fingerprint spectra, perform the dissolution consistency detection process for the sample liquid and the standard reference solution.

[0011] Optionally, constructing the dynamic dissolution environment of the compound glycyrrhiza tablets based on the main components and the application scenario includes:

[0012] Determine the simulation parameters of the compound glycyrrhiza tablets, and based on the application scenario, determine the intestinal physiological parameters of the compound glycyrrhiza tablets;

[0013] According to the main components, determine the drug characteristics of the compound glycyrrhiza tablets, where the drug characteristics include: drug physical characteristics and drug chemical characteristics;

[0014] According to the intestinal physiological parameters and the drug characteristics, determine the environmental simulation medium of the compound glycyrrhiza tablets and analyze the dissolution behavior of the compound glycyrrhiza tablets;

[0015] Based on the simulation parameters, the dissolution behavior, and the environmental simulation medium, construct the initial dynamic dissolution model of the compound glycyrrhiza tablets;

[0016] According to the simulation parameters, perform simulation operation on the initial dynamic dissolution model to obtain a simulation result;

[0017] According to the simulation result, analyze the model performance of the initial dynamic dissolution model. When the model performance meets the preset model performance standard, use the initial dynamic dissolution model as the dynamic dissolution model;

[0018] Based on the dynamic dissolution model, construct the dynamic dissolution environment of the compound glycyrrhiza tablets;

[0019] Optionally, extracting the sample liquid of the dissolution solution includes:

[0020] Configure the sterile filter membrane for the dissolution solution, and based on the sterile filter membrane, filter the dissolution solution to obtain a filtered solution;

[0021] Determine the centrifugation speed and centrifugation time of the filtered solution, and centrifuge the filtered solution based on the centrifugation speed and the centrifugation time to obtain a centrifuged solution;

[0022] Analyze the drug concentration range of the centrifuged solution and determine the analytical concentration requirement of the dissolution solution;

[0023] Calculate the dilution factor of the centrifuged solution according to the drug concentration range and the analytical concentration requirement;

[0024] Dilute the centrifuged solution according to the dilution factor to obtain a sample liquid.

[0025] Optionally, constructing the chromatographic detection environment of the sample liquid includes:

[0026] Configure the chromatograph for the sample liquid and identify the chromatographic column of the sample liquid;

[0027] Prepare the mobile phase for the sample liquid and degas the chromatographic column based on the mobile phase to obtain a degassed chromatographic column;

[0028] Determine the column temperature of the degassed chromatographic column based on the drug characteristics corresponding to the sample liquid;

[0029] Determine the initial flow rate of the mobile phase, and perform an adaptability test on the sample liquid using the chromatograph based on the initial flow rate and the column temperature to obtain an adaptability test result;

[0030] Analyze the chromatographic detection performance of the chromatograph according to the adaptability test result. When the chromatographic detection performance does not meet the preset chromatographic detection performance standard, optimize the initial flow rate to obtain an optimized flow rate;

[0031] Perform an adaptability test on the sample liquid using the chromatograph based on the optimized flow rate and the column temperature to obtain an optimized test result;

[0032] Analyze the optimized detection performance of the chromatograph according to the optimized test result. When the optimized detection performance meets the preset chromatographic detection performance standard, use the optimized flow rate as the optimal flow rate;

[0033] Construct the chromatographic detection environment of the sample liquid according to the optimal flow rate, the column temperature, and the chromatograph.

[0034] Optionally, determining the dissolution amount of the sample liquid according to the sample chromatogram includes:

[0035] Determine the volume of the dissolution medium corresponding to the sample liquid;

[0036] Identify the target active ingredient in the sample chromatogram, and determine the target peak of the sample chromatogram according to the target active ingredient;

[0037] Measure the target peak to obtain the target peak height;

[0038] Determine the linear relationship coefficient between the target peak height and the target active ingredient;

[0039] Calculate the dissolution amount of the sample liquid based on the linear relationship coefficient, the target peak height, and the volume of the dissolution medium.

[0040] Optionally, the step of using a preset chromatographic peak identification algorithm to identify the standard fingerprint peak area and the sample fingerprint peak area of the standard chromatogram and the sample chromatogram respectively includes:

[0041] Use a preset chromatographic peak identification algorithm to identify the standard fingerprint peak group and the sample fingerprint peak group of the standard chromatogram and the sample chromatogram respectively;

[0042] Determine the standard peak parameters and the sample peak parameters of the standard fingerprint peak group and the sample fingerprint peak group respectively;

[0043] Calculate the standard peak average position and the standard peak width standard deviation of the standard fingerprint peak group based on the standard peak parameters;

[0044] Calculate the sample peak average position and the sample peak width standard deviation of the sample fingerprint peak group based on the sample peak parameters;

[0045] Calculate the standard fingerprint peak area and the sample fingerprint peak area of the standard chromatogram and the sample chromatogram respectively according to the standard peak average position, the standard peak width standard deviation, the sample peak average position, and the sample peak width standard deviation.

[0046] Optionally, the step of calculating the similarity of the component contents of the sample liquid and the standard reference solution according to the standard fingerprint peak area and the sample fingerprint peak area includes:

[0047] Unify the number of fingerprint peaks of the standard peak group corresponding to the standard fingerprint peak area and the sample peak group corresponding to the sample fingerprint peak area;

[0048] Perform normalization processing on the standard fingerprint peak area and the sample fingerprint peak area to obtain the normalized standard peak area and the normalized sample peak area;

[0049] Calculate the similarity of the component contents of the sample liquid and the standard reference solution according to the number of fingerprint peaks, the normalized standard peak area, and the normalized sample peak area.

[0050] Optionally, calculating the macro qualitative similarity and macro quantitative similarity of the sample liquid and the standard control solution according to the dissolution curve and the standard dissolution curve includes:

[0051] Determine the number of dissolution measurement time points of the dissolution curve and the standard dissolution curve;

[0052] Based on the number of dissolution measurement time points, uniformly extract the sample time points and standard time points of the dissolution curve and the standard dissolution curve;

[0053] According to the sample time points and the standard time points, map the sample dissolution degrees of the dissolution curve and the standard dissolution degrees of the standard dissolution curve;

[0054] Calculate the macro qualitative similarity and macro quantitative similarity of the sample liquid and the standard control solution according to the standard dissolution degrees, the sample dissolution degrees and the number of dissolution measurement time points.

[0055] Optionally, respectively performing ultraviolet spectrum detection on the standard control solution and the sample liquid to obtain a standard ultraviolet fingerprint spectrum and a sample ultraviolet fingerprint spectrum includes:

[0056] Construct an ultraviolet spectrum detection environment for the standard control solution and the sample liquid;

[0057] Determine the detection wavelength range of the standard control solution and the sample liquid;

[0058] Determine the spectrometer scanning speed and spectrometer resolution of the standard control solution and the sample liquid;

[0059] According to the ultraviolet spectrum detection environment, the detection wavelength range, the spectrometer scanning speed and the spectrometer resolution, perform ultraviolet spectrum detection on the standard control solution and the sample liquid to obtain standard spectrum data and sample spectrum data;

[0060] According to the standard spectrum data and the sample spectrum data, respectively construct the standard ultraviolet fingerprint spectrum of the standard control solution and the sample ultraviolet fingerprint spectrum of the sample liquid.

[0061] To solve the above problems, the present invention also provides a detection and evaluation system for the dissolution consistency of compound liquorice tablets, and the system includes:

[0062] A dynamic environment simulation module, configured to analyze the main components and application scenarios of compound liquorice tablets, and construct a dynamic dissolution environment of the compound liquorice tablets based on the main components and the application scenarios;

[0063] A sample solution extraction module, which is used to perform a dissolution test on the compound liquorice tablets based on the dynamic dissolution environment to obtain a dissolution solution, and extract a sample liquid of the dissolution solution;

[0064] A dissolution curve construction module, which is used to construct a chromatographic detection environment for the sample liquid, detect a sample chromatogram of the sample liquid based on the chromatographic detection environment, determine the dissolution amount of the sample liquid according to the sample chromatogram, and construct a dissolution curve of the sample liquid based on the dissolution amount;

[0065] A content similarity calculation module, which is used to construct a standard control solution for the sample liquid, detect a standard chromatogram of the standard control solution based on a liquid chromatography detection environment, respectively identify the standard fingerprint peak area and the sample fingerprint peak area of the standard chromatogram and the sample chromatogram by using a preset chromatographic peak recognition algorithm, and calculate the component content similarity between the sample liquid and the standard control solution according to the standard fingerprint peak area and the sample fingerprint peak area;

[0066] A dissolution consistency evaluation module, which is used to analyze the standard dissolution curve of the standard control solution, calculate the macro qualitative similarity and the macro quantitative similarity between the sample liquid and the standard control solution according to the dissolution curve and the standard dissolution curve, respectively perform ultraviolet spectrum detection on the standard control solution and the sample liquid to obtain a standard ultraviolet fingerprint spectrum and a sample ultraviolet fingerprint spectrum, analyze the ultraviolet fingerprint spectrum similarity between the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum, and perform dissolution consistency detection processing on the sample liquid and the standard control solution according to the macro qualitative similarity, the macro quantitative similarity, the component content similarity and the ultraviolet fingerprint spectrum similarity.

[0067] In the embodiments of the present invention, by constructing the dynamic dissolution environment of the compound liquorice tablets based on the main ingredients and the application scenarios, the dissolution behavior of different batches of drugs can be ensured to be consistent, thereby guaranteeing the product quality; optionally, in the embodiments of the present invention, by extracting the sample liquid of the dissolution solution, the release rate and degree of the active ingredients in the compound liquorice tablets can be analyzed to understand the behavior of the drug in the dissolution medium; in the embodiments of the present invention, by determining the dissolution amount of the sample liquid according to the sample chromatogram, the dissolution amount of the specific components in the sample liquid can be accurately calculated, so as to perform quantitative analysis; in the embodiments of the present invention, by using the preset chromatographic peak recognition algorithm to respectively identify the standard fingerprint peak area of the standard chromatogram and the sample chromatogram and the sample fingerprint peak area, the trend of the compound content in the sample can be analyzed for quality control or process monitoring. In the embodiments of the present invention, by calculating the component content similarity between the sample liquid and the standard reference solution according to the standard fingerprint peak area and the sample fingerprint peak area, it is helpful to analyze the overall chemical composition consistency between the sample and the standard. Finally, in the embodiments of the present invention, by performing the dissolution consistency detection process on the sample liquid and the standard reference solution according to the macro qualitative similarity, the macro quantitative similarity, the component content similarity and the ultraviolet fingerprint similarity, the consistency of the dissolution characteristics between the sample liquid and the standard reference solution can be ensured, thereby guaranteeing the uniformity and stability between drug batches. Therefore, the accuracy of the dissolution consistency detection and evaluation of the compound liquorice tablets is improved. BRIEF DESCRIPTION OF THE DRAWINGS

[0068] Figure 1 FIG. is a schematic flow chart of a method for detecting and evaluating the dissolution consistency of compound liquorice tablets provided by an embodiment of the present invention;

[0069] Figure 2 FIG. is a functional module diagram of a detection and evaluation system for the dissolution consistency of compound liquorice tablets provided by an embodiment of the present invention;

[0070] The implementation, functional features and advantages of the object of the present invention will be further described with reference to the embodiments and the accompanying drawings. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0071] It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0072] The embodiments of the present application provide a detection and evaluation method for the dissolution consistency of compound liquorice tablets. The execution subject of the detection and evaluation method for the dissolution consistency of compound liquorice tablets includes, but is not limited to, at least one of electronic devices such as a server, a terminal, etc. that can be configured to execute the method provided by the embodiments of the present application. In other words, the detection and evaluation method for the dissolution consistency of compound liquorice tablets can be executed by software or hardware installed on a terminal device or a server device, and the software can be a blockchain platform. The server includes, but is not limited to: a single server, a server cluster, a cloud server, or a cloud server cluster, etc. The server can be an independent server or a cloud server that provides basic cloud computing services such as cloud services, cloud databases, cloud computing, cloud functions, cloud storage, network services, cloud communications, middleware services, domain name services, security services, Content Delivery Network (CDN), and big data and artificial intelligence platforms.

[0073] Referring to Figure 1 As shown, it is a schematic flowchart of the detection and evaluation method for the dissolution consistency of compound liquorice tablets provided by an embodiment of the present invention. In this embodiment, the detection and evaluation method for the dissolution consistency of compound liquorice tablets includes:

[0074] S1. Analyze the main components and application scenarios of the compound liquorice tablets, and based on the main components and the application scenarios, construct a dynamic dissolution environment for the compound liquorice tablets;

[0075] In the embodiments of the present invention, by analyzing the main components and application scenarios of the compound liquorice tablets, a dissolution environment close to the physiological conditions of the human body can be constructed to better predict the behavior of the drug in the body. Among them, the main components refer to the key drug components with therapeutic effects. The application scenario refers to the situation where the drug or product is used under specific conditions or circumstances.

[0076] Optionally, as an embodiment of the present invention, the analysis of the main components and application scenarios of the compound liquorice tablets can be performed by molecular imprinting technology, such as preparing a molecularly imprinted polymer with high affinity for the compound liquorice tablets, and analyzing the main components of the compound liquorice tablets through the molecularly imprinted polymer.

[0077] In the embodiments of the present invention, by constructing a dynamic dissolution environment for the compound liquorice tablets based on the main components and the application scenarios, the dissolution behavior of different batches of drugs can be ensured to be consistent, thereby guaranteeing the product quality. Among them, the dynamic dissolution environment refers to an experimental setting that simulates the release and dissolution conditions of the drug in the body (such as dissolution medium, environmental temperature, dynamic pH value, and dissolution device, etc.), and this environment will change during the test to more realistically simulate the behavior of the drug in the gastrointestinal tract.

[0078] As an embodiment of the present invention, constructing the dynamic dissolution environment of the compound liquorice tablets based on the main components and the application scenarios includes:

[0079] Determine the simulation parameters of the compound liquorice tablets, and determine the intestinal physiological parameters of the compound liquorice tablets based on the application scenarios;

[0080] Determine the drug properties of the compound liquorice tablets according to the main components, wherein the drug properties include: drug physical properties and drug chemical properties;

[0081] Determine the environmental simulation medium of the compound liquorice tablets according to the intestinal physiological parameters and the drug properties, and analyze the dissolution behavior of the compound liquorice tablets;

[0082] Construct an initial dynamic dissolution model of the compound liquorice tablets based on the simulation parameters, the dissolution behavior, and the environmental simulation medium;

[0083] Simulate and run the initial dynamic dissolution model according to the simulation parameters to obtain simulation results;

[0084] Analyze the model performance of the initial dynamic dissolution model according to the simulation results. When the model performance meets the preset model performance standard, use the initial dynamic dissolution model as the dynamic dissolution model;

[0085] Construct the dynamic dissolution environment of the compound liquorice tablets based on the dynamic dissolution model;

[0086] Among them, the simulation parameters refer to a series of conditional variables that need to be set or considered when simulating the dynamic dissolution environment of compound liquorice tablets, such as ionic strength, drug content, digestive enzyme activity, etc. The intestinal physiological parameters refer to a series of parameters related to the physiological functions of the human intestine that need to be considered when simulating the dynamic dissolution environment of drugs in the human intestine, such as pH value, peristaltic speed, temperature, etc. The drug properties refer to the physical and chemical attributes of the drug itself. The drug physical properties refer to the properties exhibited by the drug without changing its chemical composition, such as size, shape, solubility, etc. The drug chemical properties refer to the properties of the drug at the chemical level, which usually involve the chemical composition, structure, chemical reactivity of the drug, and its interaction with organisms. The environmental simulation medium refers to a substance used to simulate the specific environment in the body (such as the gastrointestinal environment) of the drug, such as artificial gastric juice, artificial intestinal juice, normal saline, etc. The dissolution behavior refers to the process by which a drug is released from its solid preparation into the dissolution medium. The initial dynamic dissolution model refers to the first mathematical or computational model established to simulate and predict the dissolution behavior of drugs in the body. The simulation results refer to the data and conclusions obtained by running the simulation. The model performance refers to the performance and ability of a mathematical model or computational model when completing a specific task or simulating a specific phenomenon. The preset model performance standard refers to the performance indicators and their thresholds preset according to project requirements, application scenarios, and business goals before designing or developing the model. The dynamic dissolution model refers to a mathematical model used to simulate the dissolution process of drugs in the dynamic environment in the body.

[0087] Optionally, constructing the initial dynamic dissolution model of the compound liquorice tablet based on the simulation parameters, the dissolution behavior, and the environmental simulation medium can be constructed by molecular dynamics simulation, such as simulating the interaction between the drug molecules corresponding to the compound liquorice tablet and the simulation medium through molecular dynamics simulation, so as to construct the initial dynamic dissolution model of the compound liquorice tablet.

[0088] S2. Based on the dynamic dissolution environment, perform a dissolution test on the compound liquorice tablet to obtain a dissolution solution, and extract a sample liquid of the dissolution solution.

[0089] In the embodiment of the present invention, by performing a dissolution test on the compound liquorice tablet based on the dynamic dissolution environment to obtain a dissolution solution, the release rate and degree of the compound liquorice tablet in the simulated gastrointestinal environment can be understood in detail, so as to evaluate its release characteristics. Among them, the dissolution solution refers to the resulting solution when the drug is released from its preparation into the dissolution medium in the dissolution experiment.

[0090] Optionally, as an embodiment of the present invention, performing a dissolution test on the compound liquorice tablet based on the dynamic dissolution environment to obtain a dissolution solution includes:

[0091] Based on the dynamic dissolution environment, determine the dissolution test parameters of the compound glycyrrhiza tablets;

[0092] According to the dissolution test parameters, construct the sampling time gradient of the compound glycyrrhiza tablets;

[0093] According to the sampling time gradient, conduct a dissolution test on the compound glycyrrhiza tablets to obtain a dissolution solution.

[0094] Among them, the dissolution test parameters refer to a series of conditions that need to be preset and controlled during the dissolution test, including dissolution media (such as water, 0.1N hydrochloric acid, phosphate buffer solutions (with different pH values, such as pH 4.5, 6.8, etc.)), temperature (usually set at 37°C ± 0.5°C), stirring speed, and analysis methods (such as ultraviolet-visible spectroscopy). The sampling time gradient refers to a series of preset sampling time points at certain time intervals during the dissolution test, such as 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes, etc.

[0095] In the embodiment of the present invention, by extracting the sample liquid of the dissolution solution, the release rate and degree of the active ingredients in the compound glycyrrhiza tablets can be analyzed, and the behavior of the drug in the dissolution medium can be understood. Among them, the sample liquid refers to the liquid sample obtained after a series of operations on the dissolution solution for subsequent analysis.

[0096] As an embodiment of the present invention, the extraction of the sample liquid of the dissolution solution includes:

[0097] Configure the sterile filter membrane of the dissolution solution, and based on the sterile filter membrane, filter the dissolution solution to obtain a filtered solution;

[0098] Determine the centrifugation speed and centrifugation time of the filtered solution, and based on the centrifugation speed and the centrifugation time, centrifuge the filtered solution to obtain a centrifuged solution;

[0099] Analyze the drug concentration range of the centrifuged solution to determine the analytical concentration requirement of the dissolution solution,

[0100] According to the drug concentration range and the analytical concentration requirement, calculate the dilution factor of the centrifuged solution;

[0101] Dilute the centrifuged solution according to the dilution factor to obtain a sample liquid.

[0102] Among them, the sterile filtration membrane refers to a membrane used to filter a solution to remove macromolecules. The filtered solution refers to the solution after being filtered by the sterile filtration membrane. The centrifugation speed refers to the rotational speed reached by the centrifuge rotor during the centrifugation operation. The centrifugation time refers to the total duration during which the sample is under the action of centrifugal force in the centrifuge during the centrifugation operation. The post - centrifugation solution refers to the liquid part separated from the centrifuge tube after the centrifugation operation. The drug concentration range refers to the content range in which the drug exists in the post - centrifugation solution. The analytical concentration requirement refers to a certain range or specific value that the drug concentration in the analytical sample needs to meet in order to ensure the accuracy and reliability of the analytical method during the drug analysis process. The dilution factor refers to the multiple by which the original sample is diluted in order to adjust the drug concentration in the sample within the linear range or the limit of quantification of the analytical method.

[0103] Optionally, centrifuging the filtered solution based on the centrifugation speed and the centrifugation time to obtain the post - centrifugation solution can be achieved by using a centrifuge.

[0104] S3. Construct a chromatographic detection environment for the sample liquid, detect a sample chromatogram of the sample liquid based on the chromatographic detection environment, determine the dissolution amount of the sample liquid according to the sample chromatogram, and construct a dissolution curve of the sample liquid based on the dissolution amount.

[0105] In the embodiment of the present invention, constructing the chromatographic detection environment for the sample liquid can improve the accuracy and reliability of the analysis results. Among them, the chromatographic detection environment refers to a set of experimental conditions and equipment set up for chromatographic analysis.

[0106] As an embodiment of the present invention, constructing the chromatographic detection environment for the sample liquid includes:

[0107] Configure a chromatograph for the sample liquid and identify the chromatographic column of the sample liquid;

[0108] Prepare the mobile phase for the sample liquid, and degas the chromatographic column based on the mobile phase to obtain a degassed chromatographic column;

[0109] Determine the column temperature of the degassed chromatographic column based on the drug characteristics corresponding to the sample liquid;

[0110] Determine the initial flow rate of the mobile phase, and perform an adaptability test on the sample liquid using the chromatograph based on the initial flow rate and the column temperature to obtain an adaptability test result;

[0111] Analyze the chromatographic detection performance of the chromatograph according to the adaptability test result. When the chromatographic detection performance does not meet the preset chromatographic detection performance standard, optimize the initial flow rate to obtain an optimized flow rate.

[0112] Based on the optimized flow rate and the column temperature, use the chromatograph to perform an adaptability test on the sample liquid to obtain an optimized test result;

[0113] According to the optimized test result, analyze the optimized detection performance of the chromatograph. When the optimized detection performance meets the preset chromatographic detection performance standard, use the optimized flow rate as the optimal flow rate;

[0114] According to the optimal flow rate, the column temperature, and the chromatograph, construct a chromatographic detection environment for the sample liquid.

[0115] Among them, the chromatograph refers to an analytical instrument used to separate and analyze each component in a mixture. The chromatographic column refers to the core component in the chromatograph used to separate different components in the mixture. The mobile phase refers to the liquid or gas medium that carries the sample through the chromatographic column during the chromatographic analysis process. The degassed chromatographic column refers to the chromatographic column after removing the air in the chromatographic column using the mobile phase. The column temperature refers to the constant temperature at which the chromatographic column is heated or maintained during the chromatographic analysis process. The initial flow rate refers to the flow rate of the mobile phase set at the beginning of the analysis for the chromatographic column during the chromatographic analysis. The adaptability test refers to the test performed on the chromatographic system during the configuration of the chromatograph to ensure that parameters such as the chromatographic column, mobile phase, column temperature, and flow rate can meet the specific requirements for drug analysis in the sample liquid, such as: chromatographic column suitability test, suitability test of the mobile phase, etc. The adaptability test result refers to the output result of a series of adaptability evaluations performed on the chromatographic detection process under specific test conditions. The chromatographic detection performance refers to the comprehensive performance of the detector's response ability to chromatographic peaks and its related characteristics during the chromatographic analysis process. The optimized flow rate refers to the flow rate after optimizing the initial flow rate. The optimal flow rate refers to the determined flow rate of the mobile phase that is most suitable for the current analysis task.

[0116] Optionally, determining the column temperature of the degassed chromatographic column based on the drug characteristics of the sample liquid can be determined by the method of temperature gradient experiment. For example, determine the column temperature gradient of the degassed chromatographic column, test the analysis effect of the chromatograph according to the column temperature gradient, and determine the column temperature of the degassed chromatographic column according to the analysis effect.

[0117] In the embodiment of the present invention, by detecting the sample chromatogram of the sample liquid based on the chromatographic detection environment, it can be used to quantitatively analyze the content of each component in the sample and monitor the change of the sample components over time, thereby analyzing the stability of the sample. Among them, the sample chromatogram refers to a chart that shows the separation and detection of each component in the sample over time or the volume of the mobile phase.

[0118] Optionally, as an embodiment of the present invention, detecting the sample chromatogram of the sample liquid based on the chromatographic detection environment includes:

[0119] Detecting the sample liquid by using a preset chromatograph based on the chromatographic detection environment to obtain chromatographic detection data;

[0120] Generating a sample chromatogram of the sample liquid according to the chromatographic detection data.

[0121] Wherein, the preset chromatograph refers to a chromatographic instrument pre-selected and configured according to factors such as analysis purpose, sample characteristics, and analysis requirements during the experimental design and development stage. The chromatographic detection data refers to a series of information collected during the operation of the chromatograph, which reflects the chromatographic behavior of each component in the sample, such as peak area, peak height, peak width, etc.

[0122] In the embodiment of the present invention, by determining the dissolution amount of the sample liquid according to the sample chromatogram, the dissolution amount of a specific component in the sample liquid can be accurately calculated, so as to perform quantitative analysis. Wherein, the dissolution amount refers to the amount of a drug or active ingredient released from a solid dosage form into a solution in a specific dissolution medium.

[0123] As an embodiment of the present invention, determining the dissolution amount of the sample liquid according to the sample chromatogram includes:

[0124] Determining the volume of the dissolution medium corresponding to the sample liquid;

[0125] Identifying the target active ingredient of the sample chromatogram, and determining the target peak of the sample chromatogram according to the target active ingredient;

[0126] Measuring the target peak to obtain the target peak height;

[0127] Determining the linear relationship coefficient between the target peak height and the target active ingredient;

[0128] Based on the linear relationship coefficient, the target peak height, and the volume of the dissolution medium, calculating the dissolution amount of the sample liquid by using the following formula:

[0129]

[0130] Wherein, R represents the dissolution amount, G represents the target peak height, b represents a constant, a represents the linear relationship coefficient, and H represents the volume of the dissolution medium.

[0131] Among them, the dissolution medium volume refers to the volume of the liquid medium used for the dissolution test. The target active ingredient refers to the main ingredient with pharmacological activity in the pharmaceutical preparation. The target peak refers to the chromatographic peak representing the target active ingredient in chromatographic analysis. The target peak height refers to the vertical height of the target peak on the chromatogram in chromatographic analysis. The linear relationship coefficient is a statistic used to measure the strength and direction of the linear relationship between two variables, which can be set to 0.98 in the present invention. The constant refers to a correction parameter introduced to eliminate or reduce the influence of the background noise of the instrument detection system on the measurement result. For example, if 5 blank determinations are performed and the baseline noise values obtained are 9, 11, 10, 10, and 12 units respectively, then the constant is the average background noise correction value of 10.4.

[0132] Optionally, the linear relationship coefficient between the target peak height and the target active ingredient can be determined by linear regression analysis.

[0133] In the embodiment of the present invention, by constructing the dissolution curve of the sample liquid based on the dissolution amount, the rate and degree of the drug released from the preparation into the dissolution medium can be intuitively displayed, and the dissolution characteristics of the drug can be quickly understood. Among them, the dissolution curve refers to a chart depicting the change in the amount of drug released from its preparation into the dissolution medium over time.

[0134] Optionally, as an embodiment of the present invention, the dissolution curve of the sample liquid can be constructed by linear or non-linear fitting methods based on the dissolution amount.

[0135] S4. Construct a standard control solution of the sample liquid, detect the standard chromatogram of the standard control solution based on the liquid chromatography detection environment, respectively identify the standard fingerprint peak area and the sample fingerprint peak area of the standard chromatogram and the sample chromatogram using a preset chromatographic peak recognition algorithm, and calculate the similarity of the component content between the sample liquid and the standard control solution according to the standard fingerprint peak area and the sample fingerprint peak area.

[0136] In the embodiment of the present invention, by constructing a standard control solution of the sample liquid, the accuracy and reliability of the analysis result can be ensured, which is beneficial for substance identification, qualitative analysis, and quality control. Among them, the standard control solution refers to a solution with known composition and concentration, which is used as a reference in the analysis process.

[0137] In the embodiment of the present invention, by detecting the standard chromatogram of the standard control solution in the liquid chromatography detection environment, the retention time and peak shape of the known compound are provided, which helps to identify and qualitatively analyze the target compound in the sample chromatogram. Among them, the standard chromatogram refers to the chromatogram obtained by using a standard substance (standard control solution) with a known concentration under specific chromatographic conditions.

[0138] In an embodiment of the present invention, by using a preset chromatographic peak recognition algorithm to respectively identify the standard fingerprint peak areas and sample fingerprint peak areas of the standard chromatogram and the sample chromatogram, the trend of the compound content in the sample can be analyzed, which is used for quality control or process monitoring. Among them, the preset chromatographic peak recognition algorithm refers to one or more computer algorithms for automatically identifying and quantifying chromatographic peaks from chromatographic data.

[0139] As an embodiment of the present invention, the using a preset chromatographic peak recognition algorithm to respectively identify the standard fingerprint peak areas and sample fingerprint peak areas of the standard chromatogram and the sample chromatogram includes:

[0140] Using a preset chromatographic peak recognition algorithm to respectively identify the standard fingerprint peak groups and sample fingerprint peak groups of the standard chromatogram and the sample chromatogram;

[0141] Respectively determining the standard peak parameters and sample peak parameters of the standard fingerprint peak group and the sample fingerprint peak group;

[0142] Based on the standard peak parameters, calculating the standard peak average position and the standard deviation of the standard peak width of the standard fingerprint peak group;

[0143] Based on the sample peak parameters, calculating the sample peak average position and the standard deviation of the sample peak width of the sample fingerprint peak group;

[0144] According to the standard peak average position, the standard deviation of the standard peak width, the sample peak average position, and the standard deviation of the sample peak width, use the following formula to calculate the standard fingerprint peak areas and sample fingerprint peak areas of the standard chromatogram and the sample chromatogram respectively:

[0145]

[0146] Among them, M b represents the standard fingerprint peak area, M y represents the sample fingerprint peak area, θ represents the upper limit of integration, -θ represents the lower limit of integration, B b represents the standard deviation of the standard peak width, π represents pi, b represents the standard position point of the standard chromatogram, P b represents the standard peak average position, e represents the exponential function with base e, B y represents the standard deviation of the sample peak width, P y represents the sample peak average position, and y represents the sample position point of the sample chromatogram.

[0147] Among them, the standard fingerprint peak group refers to a set of specific chromatographic peaks identified from the chromatogram of the standard reference solution. The sample fingerprint peak group refers to a set of specific chromatographic peaks identified from the chromatogram of the sample to be analyzed. The standard peak parameters refer to various characteristic parameters of the chromatographic peaks obtained from the standard chromatogram, such as the standard peak position, standard peak width, etc. The sample peak parameters refer to various characteristic parameters of the chromatographic peaks obtained from the sample chromatogram, such as the sample peak position, sample peak width, etc. The standard peak average position refers to the average value of the retention times measured under different conditions for the standard fingerprint peak group. The standard deviation of the standard peak width refers to the standard deviation of the peak width variation of the standard fingerprint peak group in different measurements. The sample peak average position refers to the average value of the retention times measured under different conditions for the sample fingerprint peak group. The standard deviation of the sample peak width refers to the standard deviation of the peak width variation of the sample fingerprint peak group in different measurements.

[0148] Optionally, the determination of the standard peak parameters and sample peak parameters of the standard fingerprint peak group and the sample fingerprint peak group respectively can be determined by machine learning algorithms, such as clustering analysis, principal component analysis, artificial neural network, etc.

[0149] By calculating the similarity of the component contents of the sample liquid and the standard reference solution according to the standard fingerprint peak area and the sample fingerprint peak area in the embodiments of the present invention, it can help analyze the overall chemical composition consistency between the sample and the standard. Among them, the component content similarity refers to the degree of similarity between the contents of each component in the sample and the contents of the corresponding components in the standard reference solution.

[0150] As an embodiment of the present invention, the calculation of the similarity of the component contents of the sample liquid and the standard reference solution according to the standard fingerprint peak area and the sample fingerprint peak area includes:

[0151] Unify the number of fingerprint peaks of the standard peak group corresponding to the standard fingerprint peak area and the sample peak group corresponding to the sample fingerprint peak area;

[0152] Perform normalization processing on the standard fingerprint peak area and the sample fingerprint peak area to obtain the normalized standard peak area and the normalized sample peak area;

[0153] According to the number of fingerprint peaks, the normalized standard peak area, and the normalized sample peak area, use the following formula to calculate the similarity of the component contents of the sample liquid and the standard reference solution:

[0154]

[0155] Wherein, X represents the similarity of component content, n represents the number of fingerprint peaks, qi represents the peak area of the i-th normalized sample, and pi represents the peak area of the i-th standard fingerprint peak.

[0156] Wherein, the number of fingerprint peaks refers to the number of individual peaks that are identified and used for analysis. The normalized standard peak area refers to the peak area after standardizing the peak area of the standard solution. The normalized sample peak area refers to the peak area after standardizing the peak area of the sample solution.

[0157] S5. Analyze the standard dissolution curve of the standard control solution. According to the dissolution curve and the standard dissolution curve, calculate the macro qualitative similarity and macro quantitative similarity between the sample liquid and the standard control solution. Perform ultraviolet spectrum detection on the standard control solution and the sample liquid respectively to obtain the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum. Analyze the similarity of the ultraviolet fingerprint spectra of the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum. According to the macro qualitative similarity, the macro quantitative similarity, the component content similarity, and the ultraviolet fingerprint spectrum similarity, perform the dissolution consistency detection process on the sample liquid and the standard control solution.

[0158] In the embodiment of the present invention, by analyzing the standard dissolution curve of the standard control solution, the dissolution behavior of each component in compound liquorice tablets can be more accurately quantified, thereby improving the quality control standard. Wherein, the standard dissolution curve refers to a chart obtained by performing a dissolution test on the standard control solution, which shows the change in the concentration of the active ingredient or labeled ingredient in the drug dissolved over time.

[0159] In the embodiment of the present invention, by calculating the macro qualitative similarity and macro quantitative similarity between the sample liquid and the standard control solution according to the dissolution curve and the standard dissolution curve, it can be analyzed and evaluated whether the dissolution behaviors of different batches of drugs are consistent, thereby ensuring the stability of product quality. Wherein, the macro qualitative similarity refers to a parameter used to evaluate the similarity of the dissolution curve shapes of different batches of drugs in drug quality control. The macro quantitative similarity refers to the similarity or consistency in numerical values of the dissolution curves of different batches of drugs in drug quality control.

[0160] As an embodiment of the present invention, the calculating the macro qualitative similarity and macro quantitative similarity between the sample liquid and the standard control solution according to the dissolution curve and the standard dissolution curve includes:

[0161] Determine the number of dissolution measurement time points of the dissolution curve and the standard dissolution curve;

[0162] Based on the dissolution measurement time points, uniformly extract the sample time points and standard time points of the dissolution curve and the standard dissolution curve;

[0163] According to the sample time points and the standard time points, map the sample dissolution degrees of the dissolution curve and the standard dissolution degrees of the standard dissolution curve;

[0164] According to the standard dissolution degrees, the sample dissolution degrees, and the number of dissolution measurement time points, use the following formula to calculate the macro qualitative similarity and macro quantitative similarity between the sample liquid and the standard reference solution:

[0165]

[0166] where DX represents the macro qualitative similarity, DL represents the macro quantitative similarity, m represents the number of dissolution measurement time points, R bj represents the standard dissolution degree at the j - th standard time point, R yj represents the sample dissolution degree at the j - th sample time point, and min represents the minimum value function.

[0167] Among them, the number of dissolution measurement time points refers to the specific number of time points selected for dissolution measurement during the dissolution test. The sample time point refers to the specific time point for collecting and analyzing the sample during the dissolution test. The standard time point refers to the specific time point for collecting and analyzing the standard reference solution during the dissolution test. The sample dissolution degree refers to the rate and extent of the drug released from the preparation into the dissolution medium in the sample solution under certain conditions within the specified time. The standard dissolution degree refers to the rate and extent of the drug released from the preparation into the dissolution medium in the standard reference solution under certain conditions within the specified time.

[0168] In the embodiment of the present invention, by respectively performing ultraviolet spectrum detection on the standard reference solution and the sample liquid, a standard ultraviolet fingerprint spectrum and a sample ultraviolet fingerprint spectrum can be obtained to identify whether the sample contains the expected components and whether there are additional or unknown impurities. Among them, the standard ultraviolet fingerprint spectrum refers to the spectrum obtained by performing ultraviolet spectrum detection on a standard solution with known components and concentrations under specific conditions. The sample ultraviolet fingerprint spectrum refers to the spectrum obtained by performing ultraviolet spectrum analysis on a specific sample.

[0169] As an embodiment of the present invention, the respectively performing ultraviolet spectrum detection on the standard reference solution and the sample liquid to obtain a standard ultraviolet fingerprint spectrum and a sample ultraviolet fingerprint spectrum includes:

[0170] Construct the ultraviolet spectrum detection environment for the standard reference solution and the sample liquid;

[0171] Determine the detection wavelength range of the standard reference solution and the sample liquid;

[0172] Determine the spectrometer scanning speed and spectrometer resolution of the standard reference solution and the sample liquid;

[0173] According to the ultraviolet spectrum detection environment, the detection wavelength range, the spectrometer scanning speed, and the spectrometer resolution, perform ultraviolet spectrum detection on the standard reference solution and the sample liquid to obtain standard spectrum data and sample spectrum data;

[0174] According to the standard spectrum data and the sample spectrum data, construct the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum of the standard reference solution and the sample liquid respectively.

[0175] Among them, the ultraviolet spectrum detection environment refers to the sum of a series of conditions and working environments required for ultraviolet spectrum detection. The detection wavelength range refers to the wavelength interval covered by the spectrometer when scanning and analyzing samples in ultraviolet spectrum detection. The spectrometer scanning speed refers to the measure of the spectral range passed per unit time by the spectrometer when performing spectral scanning. The spectrometer resolution refers to the ability of the spectrometer to distinguish two adjacent spectral features (such as peaks). The standard spectrum data refers to a set of verified and representative spectral information. The sample spectrum data refers to the spectral information obtained by detecting a specific sample with a spectral instrument.

[0176] In the embodiment of the present invention, by analyzing the similarity of the ultraviolet fingerprint spectra of the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum, it can be analyzed whether the quality of compound liquorice tablets meets the predetermined standard, ensuring the uniformity and stability of the product. Among them, the similarity of the ultraviolet fingerprint spectrum refers to the consistency or similarity degree of the absorption characteristics between the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum within a specific wavelength range by comparing them.

[0177] Optionally, as an embodiment of the present invention, the similarity of the ultraviolet fingerprint spectra of the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum can be analyzed by cosine similarity analysis, such as calculating the cosine angle of the spectral vectors between the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum, and determining the similarity of the ultraviolet fingerprint spectra of the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum according to the cosine angle of the spectral vectors.

[0178] In the embodiments of the present invention, by performing the dissolution consistency detection process on the sample liquid and the standard reference solution according to the macro qualitative similarity, the macro quantitative similarity, the component content similarity, and the ultraviolet fingerprint similarity, the consistency of the dissolution characteristics between the sample liquid and the standard reference solution can be ensured, thereby guaranteeing the uniformity and stability between different batches of drugs.

[0179] In the embodiments of the present invention, by constructing the dynamic dissolution environment of the compound liquorice tablets based on the main components and the application scenarios, the consistency of the dissolution behavior of different batches of drugs can be ensured, thereby guaranteeing the product quality; optionally, in the embodiments of the present invention, by extracting the sample liquid of the dissolution solution, the release rate and degree of the active ingredients in the compound liquorice tablets can be analyzed to understand the behavior of the drug in the dissolution medium; in the embodiments of the present invention, by determining the dissolution amount of the sample liquid according to the sample chromatogram, the dissolution amount of a specific component in the sample liquid can be accurately calculated for quantitative analysis; in the embodiments of the present invention, by using a preset chromatographic peak recognition algorithm to respectively identify the standard fingerprint peak area and the sample fingerprint peak area of the standard chromatogram and the sample chromatogram, the trend of the compound content in the sample can be analyzed for quality control or process monitoring. In the embodiments of the present invention, by calculating the component content similarity between the sample liquid and the standard reference solution according to the standard fingerprint peak area and the sample fingerprint peak area, it is helpful to analyze the overall chemical composition consistency between the sample and the standard. Finally, in the embodiments of the present invention, by performing the dissolution consistency detection process on the sample liquid and the standard reference solution according to the macro qualitative similarity, the macro quantitative similarity, the component content similarity, and the ultraviolet fingerprint similarity, the consistency of the dissolution characteristics between the sample liquid and the standard reference solution can be ensured, thereby guaranteeing the uniformity and stability between different batches of drugs. Therefore, the accuracy of the dissolution consistency detection and evaluation of the compound liquorice tablets is improved.

[0180] As Figure 2 shown, it is a functional module diagram of a detection and evaluation system for the dissolution consistency of compound liquorice tablets provided by an embodiment of the present invention.

[0181] The detection and evaluation system 200 for the dissolution consistency of the compound liquorice tablets described in the present invention can be installed in an electronic device. According to the functions achieved, the detection and evaluation system 200 for the dissolution consistency of the compound liquorice tablets can include a dynamic environment simulation module 201, a sample solution extraction module 202, a dissolution curve construction module 203, a content similarity calculation module 204, and a dissolution consistency evaluation module 205. The modules described in the present invention can also be referred to as units, which refer to a series of computer program segments that can be executed by a processor of an electronic device and can complete fixed functions, and are stored in the memory of the electronic device.

[0182] In this embodiment, the functions of each module / unit are as follows:

[0183] The dynamic environment simulation module 201 is used to analyze the main components and application scenarios of compound liquorice tablets, and construct a dynamic dissolution environment for the compound liquorice tablets based on the main components and the application scenarios;

[0184] The sample solution extraction module 202 is used to perform a dissolution test on the compound liquorice tablets based on the dynamic dissolution environment to obtain a dissolution solution, and extract a sample liquid of the dissolution solution;

[0185] The dissolution curve construction module 203 is used to construct a chromatographic detection environment for the sample liquid, detect a sample chromatogram of the sample liquid based on the chromatographic detection environment, determine the dissolution amount of the sample liquid according to the sample chromatogram, and construct a dissolution curve of the sample liquid based on the dissolution amount;

[0186] The content similarity calculation module 204 is used to construct a standard control solution for the sample liquid, detect a standard chromatogram of the standard control solution based on a liquid chromatography detection environment, respectively identify the standard fingerprint peak area and the sample fingerprint peak area of the standard chromatogram and the sample chromatogram by using a preset chromatographic peak recognition algorithm, and calculate the component content similarity between the sample liquid and the standard control solution according to the standard fingerprint peak area and the sample fingerprint peak area;

[0187] The dissolution consistency evaluation module 205 is used to analyze the standard dissolution curve of the standard control solution, calculate the macro qualitative similarity and the macro quantitative similarity between the sample liquid and the standard control solution according to the dissolution curve and the standard dissolution curve, respectively perform ultraviolet spectrum detection on the standard control solution and the sample liquid to obtain a standard ultraviolet fingerprint spectrum and a sample ultraviolet fingerprint spectrum, analyze the ultraviolet fingerprint spectrum similarity between the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum, and perform dissolution consistency detection processing on the sample liquid and the standard control solution according to the macro qualitative similarity, the macro quantitative similarity, the component content similarity and the ultraviolet fingerprint spectrum similarity.

[0188] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and not to limit them. Although the present invention has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that the technical solutions of the present invention can be modified or equivalently replaced without departing from the spirit and scope of the technical solutions of the present invention.

Claims

1. A method for detecting and evaluating the dissolution consistency of compound licorice tablets, characterized in that: The method comprises: Analyze the main components and application scenarios of the compound licorice tablets, and construct a dynamic dissolution environment of the compound licorice tablets based on the main components and the application scenarios; Based on the dynamic dissolution environment, a dissolution test is performed on the compound licorice tablet to obtain a dissolution solution, and a sample liquid of the dissolution solution is extracted; Constructing a chromatographic detection environment for the sample liquid, detecting a sample chromatogram of the sample liquid based on the chromatographic detection environment, determining a dissolution amount of the sample liquid according to the sample chromatogram, and constructing a dissolution curve of the sample liquid based on the dissolution amount; Constructing a standard control solution of the sample liquid, detecting a standard chromatogram of the standard control solution based on a liquid chromatography detection environment, respectively identifying the standard fingerprint peak area and the sample fingerprint peak area of ​​the standard chromatogram and the sample chromatogram using a preset chromatographic peak recognition algorithm, and calculating the similarity of the component content of the sample liquid and the standard control solution according to the standard fingerprint peak area and the sample fingerprint peak area; Analyze the standard dissolution curve of the standard control solution, calculate the macro qualitative similarity and macro quantitative similarity of the sample liquid and the standard control solution according to the dissolution curve and the standard dissolution curve, perform ultraviolet spectral detection on the standard control solution and the sample liquid respectively to obtain a standard ultraviolet fingerprint spectrum and a sample ultraviolet fingerprint spectrum, analyze the ultraviolet fingerprint spectrum similarity of the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum, and perform dissolution consistency detection processing of the sample liquid and the standard control solution according to the macro qualitative similarity, the macro quantitative similarity, the component content similarity and the ultraviolet fingerprint spectrum similarity.

2. The method for detecting and evaluating the dissolution consistency of compound licorice tablets according to claim 1, characterized in that: The method of constructing the dynamic dissolution environment of the compound licorice tablet based on the main ingredients and the application scenario includes: Determining simulation parameters of the compound licorice tablet, and determining intestinal physiological parameters of the compound licorice tablet based on the application scenario; Determining the drug properties of the compound licorice tablets according to the main components, wherein the drug properties include: drug physical properties and drug chemical properties; Determining the environmental simulation medium of the compound licorice tablet according to the intestinal physiological parameters and the drug characteristics, and analyzing the dissolution behavior of the compound licorice tablet; Based on the simulation parameters, the dissolution behavior and the environmental simulation medium, constructing an initial dynamic dissolution model of the compound licorice tablets; According to the simulation parameters, the initial dynamic dissolution model is simulated and run to obtain simulation results; Analyzing the model performance of the initial dynamic dissolution model according to the simulation results, and using the initial dynamic dissolution model as a dynamic dissolution model when the model performance meets a preset model performance standard; Based on the dynamic dissolution model, the dynamic dissolution environment of the compound licorice tablets is constructed.

3. The method for detecting and evaluating the dissolution consistency of compound licorice tablets according to claim 1, characterized in that: The step of extracting the sample liquid of the dissolution solution comprises: A sterile filtration membrane is provided for the dissolution solution, and the dissolution solution is filtered through the sterile filtration membrane to obtain a filtered solution; Determining the centrifugal speed and the centrifugal time of the filtered solution, and centrifuging the filtered solution based on the centrifugal speed and the centrifugal time to obtain a centrifuged solution; Analyze the drug concentration range of the solution after centrifugation to determine the analytical concentration requirement of the dissolution solution, Calculating the dilution multiple of the centrifuged solution according to the drug concentration range and the analytical concentration requirement; The centrifuged solution is diluted according to the dilution multiple to obtain a sample liquid.

4. The method for detecting and evaluating the dissolution consistency of compound licorice tablets according to claim 1, characterized in that: The step of constructing a chromatographic detection environment for the sample liquid comprises: configuring a chromatograph for the sample liquid and identifying a chromatographic column for the sample liquid; preparing a mobile phase of the sample liquid, and degassing the chromatographic column based on the mobile phase to obtain a degassed chromatographic column; Determining the column temperature of the degassed chromatographic column based on the drug characteristics corresponding to the sample liquid; Determining an initial flow rate of the mobile phase, and based on the initial flow rate and the column temperature, performing a suitability test on the sample liquid using the chromatograph to obtain a suitability test result; Analyzing the chromatographic detection performance of the chromatograph according to the adaptability test result, and optimizing the initial flow rate to obtain an optimized flow rate when the chromatographic detection performance does not meet the preset chromatographic detection performance standard; Based on the optimized flow rate and the column temperature, using the chromatograph to perform an adaptability test on the sample liquid to obtain an optimized test result; Analyzing the optimized detection performance of the chromatograph according to the optimized test results, and when the optimized detection performance meets the preset chromatographic detection performance standard, taking the optimized flow rate as the optimal flow rate; A chromatographic detection environment for the sample liquid is constructed according to the optimal flow rate, the column temperature and the chromatograph.

5. The method for detecting and evaluating the dissolution consistency of compound licorice tablets according to claim 1, characterized in that: Determining the dissolution amount of the sample liquid according to the sample chromatogram includes: Determining the dissolution medium volume of the sample liquid corresponding to the dissolution medium; Identifying a target active ingredient of the sample chromatogram, and determining a target peak of the sample chromatogram according to the target active ingredient; Measuring the target peak to obtain a target peak height; Determining a linear relationship coefficient between the target peak height and the target active ingredient; The dissolution amount of the sample liquid is calculated based on the linear relationship coefficient, the target peak height, and the dissolution medium volume.

6. The method for detecting and evaluating the dissolution consistency of compound licorice tablets according to claim 1, characterized in that: The method of using a preset chromatographic peak recognition algorithm to respectively identify the standard fingerprint peak area and the sample fingerprint peak area of ​​the standard chromatogram and the sample chromatogram includes: Using a preset chromatographic peak recognition algorithm to respectively identify the standard fingerprint peak group and the sample fingerprint peak group of the standard chromatogram and the sample chromatogram; Determining the standard peak parameters and sample peak parameters of the standard fingerprint peak group and the sample fingerprint peak group respectively; Based on the standard peak parameters, calculating the standard peak average position and standard peak width standard deviation of the standard fingerprint peak group; Based on the sample peak parameters, calculating the sample peak average position and sample peak width standard deviation of the sample fingerprint peak group; According to the standard peak average position, the standard peak width standard deviation, the sample peak average position and the sample peak width standard deviation, the standard fingerprint peak area of ​​the standard chromatogram, the sample chromatogram and the sample fingerprint peak area are calculated respectively.

7. The method for detecting and evaluating the dissolution consistency of compound licorice tablets according to claim 1, characterized in that: The calculating the similarity of the component contents of the sample liquid and the standard control solution according to the standard fingerprint peak area and the sample fingerprint peak area comprises: Unify the number of fingerprint peaks of the standard peak group corresponding to the standard fingerprint peak area and the number of fingerprint peaks of the sample peak group corresponding to the sample fingerprint peak area; Normalizing the standard fingerprint peak area and the sample fingerprint peak area to obtain a normalized standard peak area and a normalized sample peak area; The similarity of the component contents of the sample liquid and the standard control solution is calculated according to the number of fingerprint peaks, the normalized standard peak area and the normalized sample peak area.

8. The method for detecting and evaluating the dissolution consistency of compound licorice tablets according to claim 1, characterized in that: The step of calculating the macro qualitative similarity and macro quantitative similarity between the sample liquid and the standard control solution according to the dissolution curve and the standard dissolution curve comprises: Determining the dissolution measurement time points of the dissolution curve and the standard dissolution curve; Based on the number of dissolution determination time points, uniformly extracting the sample time points and standard time points of the dissolution curve and the standard dissolution curve; Mapping the sample dissolution rate of the dissolution curve and the standard dissolution rate of the standard dissolution curve according to the sample time point and the standard time point; According to the standard dissolution, the sample dissolution and the number of dissolution measurement time points, the macro qualitative similarity and macro quantitative similarity between the sample liquid and the standard control solution are calculated.

9. The method for detecting and evaluating the dissolution consistency of compound licorice tablets according to claim 1, characterized in that: The ultraviolet spectrum detection is performed on the standard control solution and the sample liquid respectively to obtain a standard ultraviolet fingerprint spectrum and a sample ultraviolet fingerprint spectrum, including: Constructing an ultraviolet spectrum detection environment for the standard control solution and the sample liquid; Determining the detection wavelength range of the standard control solution and the sample liquid; determining a spectrometer scanning speed and a spectrometer resolution of the standard control solution and the sample liquid; According to the ultraviolet spectrum detection environment, the detection wavelength range, the spectrometer scanning speed and the spectrometer resolution, ultraviolet spectrum detection is performed on the standard control solution and the sample liquid to obtain standard spectrum data and sample spectrum data; According to the standard spectrum data and the sample spectrum data, the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum of the standard control solution and the sample liquid are constructed respectively.

10. A detection and evaluation system for dissolution consistency of compound licorice tablets, characterized in that: A method for detecting and evaluating the dissolution consistency of a compound licorice tablet according to any one of claims 1 to 9, the system comprising: A dynamic environment simulation module, used to analyze the main components and application scenarios of the compound licorice tablets, and to construct a dynamic dissolution environment of the compound licorice tablets based on the main components and the application scenarios; A sample solution extraction module, used for performing a dissolution test on the compound licorice tablet based on the dynamic dissolution environment to obtain a dissolution solution and extracting a sample liquid of the dissolution solution; a dissolution curve construction module, used to construct a chromatographic detection environment for the sample liquid, detect a sample chromatogram of the sample liquid based on the chromatographic detection environment, determine a dissolution amount of the sample liquid according to the sample chromatogram, and construct a dissolution curve of the sample liquid based on the dissolution amount; a content similarity calculation module, used to construct a standard control solution of the sample liquid, detect a standard chromatogram of the standard control solution based on a liquid chromatography detection environment, respectively identify the standard fingerprint peak area and the sample fingerprint peak area of ​​the standard chromatogram and the sample chromatogram using a preset chromatographic peak recognition algorithm, and calculate the component content similarity of the sample liquid and the standard control solution based on the standard fingerprint peak area and the sample fingerprint peak area; The dissolution consistency evaluation module is used to analyze the standard dissolution curve of the standard control solution, calculate the macro qualitative similarity and macro quantitative similarity of the sample liquid and the standard control solution according to the dissolution curve and the standard dissolution curve, perform ultraviolet spectral detection on the standard control solution and the sample liquid respectively to obtain a standard ultraviolet fingerprint spectrum and a sample ultraviolet fingerprint spectrum, analyze the ultraviolet fingerprint spectrum similarity of the standard ultraviolet fingerprint spectrum and the sample ultraviolet fingerprint spectrum, and perform dissolution consistency detection processing of the sample liquid and the standard control solution according to the macro qualitative similarity, the macro quantitative similarity, the component content similarity and the ultraviolet fingerprint spectrum similarity.

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