A method and system for detecting drug components based on basic pharmacy

Abstract

The present invention relates to the technical field of pharmaceutical analysis, and specifically provides a method and system for detecting the components of drugs based on basic pharmacy, including the following steps: Based on the detected drug sample, measure the weight of the drug sample, add a solvent for dissolution according to a preset ratio, combine dilution and mixing, record the color, viscosity, and pH value of the solution, and generate a standardized sample solvent. In the present invention, by standardizing the drug sample, the measurement baseline is ensured, the result deviation is reduced, the credibility of the data is improved, the changes in particle size and quantity are monitored in real time, the understanding of the dissolution process is enhanced, the impedance change of the drug solution is evaluated by monitoring the current response at multiple frequencies, the analysis of electrochemical properties is strengthened, impurities are accurately detected, the chemical properties data of the drug are provided by combining the determination of spectral absorption and fluorescence characteristics, the composition components of the target drug are identified, the drug formula is ensured to meet the specified standards, and the safety and effectiveness of the drug are guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical analysis, and particularly to a method and system for detecting pharmaceutical ingredients based on basic pharmacy. Background Art

[0002] The technical field of pharmaceutical analysis focuses on using a variety of chemical, biochemical, and physical methods to quantitatively and qualitatively analyze the active ingredients and impurities in drugs and biological products, ensuring the safety, effectiveness, and quality of drugs, including chromatography, mass spectrometry, spectroscopy, and electrochemical analysis methods. Through pharmaceutical analysis, the chemical purity, structure, and concentration of drugs, as well as various key quality parameters, including dissolution rate and stability, are evaluated. Pharmaceutical analysis is crucial for multiple aspects such as drug development, production process control, product testing, and regulatory compliance, ensuring the safety of patients when using drugs.

[0003] Among them, the method for detecting pharmaceutical ingredients aims to identify and quantify the active ingredients and impurities in drugs, ensuring the quality and safety of drugs during production and use. By accurately determining the ingredients in drugs, qualitative and quantitative analysis is used to confirm the active ingredients and concentration in drugs, and to monitor the impurities and degradation products present, effectively avoiding contamination and inconsistencies in raw materials and products, protecting patients from the impact of inferior drugs. The detection of pharmaceutical ingredients is a key link in the processes of drug registration, market access, and regulatory approval, and is of great significance for drug research and development and quality control, effectively preventing unqualified drugs from entering the market and ensuring public health and safety.

[0004] Traditional methods for detecting pharmaceutical ingredients require complex sample preparation and long analysis times, resulting in delays in production environments where rapid quality control decisions are needed. When faced with complex pharmaceutical samples, they are not sensitive enough or unable to provide sufficient quantitative data when detecting low-concentration impurities or ingredients not clearly marked in drug formulations, making it difficult to comprehensively evaluate the safety and efficacy of drugs, resulting in quality problems in drug production not being identified in a timely manner, increasing the risk of unqualified drugs on the market, and posing a threat to public health. Summary of the Invention

[0005] In order to solve the technical problem of poor detection efficiency existing in the prior art, an embodiment of the present invention provides a method and system for detecting pharmaceutical ingredients based on basic pharmacy. The technical solution is as follows:

[0006] On the one hand, a method for detecting pharmaceutical ingredients based on basic pharmacy is provided, and the method includes:

[0007] S1: Based on the pharmaceutical sample, measure the weight of the pharmaceutical sample, add a solvent for dissolution according to a preset ratio, combine dilution and mixing, record the color, viscosity, and pH value of the solvent, and generate a standardized sample solvent;

[0008] S2: Based on the standardized sample solvent, detect and record in real time the information on the change in the particle size and quantity of the drug sample during the dissolution process of the drug sample, evaluate the behavior pattern of the drug sample particles in the standardized sample solvent, and obtain the dissolution rate measurement result;

[0009] S3: Utilize the dissolution rate measurement result to conduct impedance measurement of the standardized sample solvent. By monitoring the current response at multiple frequencies, analyze the impedance change of the standardized sample solvent, evaluate the electrochemical stability and reactivity of the standardized sample solvent, identify the impurities in the standardized sample solvent, and generate the standardized sample solvent impedance measurement result;

[0010] S4: According to the standardized sample solvent impedance measurement result, by measuring the spectral absorption and fluorescence characteristics of the standardized sample solvent, and combining the dissolution rate measurement result and the standardized sample solvent impedance measurement result, analyze the chemical characteristics of the drug sample, identify the active ingredients in the drug sample, and obtain the drug sample component identification list;

[0011] S5: Use the drug sample component identification list to analyze the consistency of the drug component type and dosage by comparing with the drug formula, mark and extract multiple pieces of information on unqualified drugs, and generate the drug component detection result.

[0012] As a further solution of the present invention, the dissolution rate measurement result includes the change in the particle size of the drug sample, the time series change data of the particle quantity, and the dissolution rate constant of the drug sample. The standardized sample solvent impedance measurement result includes the impedance values at multiple frequencies, the electrochemical stability rating, and the current response characteristics of the drug sample components. The drug sample component identification list includes the chemical structure, concentration ratio, impurity type, and content information of the drug active ingredients. The drug component detection result includes component deviation information, dosage deviation information, and drug information extraction records.

[0013] As a further solution of the present invention, based on the drug sample, measure the weight of the drug sample, add the solvent for dissolution according to a preset ratio, and combine dilution and mixing. The steps of recording the color, viscosity, and pH value of the solvent to generate the standardized sample solvent are specifically as follows:

[0014] S101: Based on the drug sample, use an electronic scale to measure the mass of the drug sample, record the weight of the drug sample, and generate the drug sample weight data;

[0015] S102: Based on the drug sample weight data, calculate the required amount of solvent according to the preset ratio information, and dissolve the drug to generate the drug sample dissolution result;

[0016] S103: Based on the dissolution result of the drug sample, dilute and mix the drug sample, and record the color, viscosity, and pH value of the drug sample solvent to generate a standardized sample solvent.

[0017] As a further aspect of the present invention, the steps of obtaining the dissolution rate measurement result by detecting and recording in real time the change information of the particle size and quantity of the drug sample during the dissolution process of the drug sample based on the standardized sample solvent, and evaluating the behavior pattern of the drug sample particles in the standardized sample solvent are specifically as follows:

[0018] S201: Based on the standardized sample solvent, monitor and record in real time the change process of the drug sample particles during the dissolution process of the drug sample to generate drug sample particle change monitoring data;

[0019] S202: Based on the drug sample particle change monitoring data, analyze the particle size and quantity of the drug sample particles at multiple time points to generate drug sample particle behavior analysis data;

[0020] S203: Based on the drug sample particle behavior analysis data, calculate the dissolution rate of the drug sample particles in the standardized sample solvent, analyze and record the behavior pattern of the drug sample particle dissolution, and generate a dissolution rate measurement result.

[0021] As a further aspect of the present invention, the specific formula for calculating the dissolution rate of the drug sample particles in the standardized sample solvent is:

[0022]

[0023] Wherein, represents the dissolution rate, represents the density of the drug sample particles, represents the differential symbol, represents an infinitesimal increment of time, represents the derivative with respect to time, which is used to calculate the change rate of the drug sample particle volume with time, is the pi, represents the radius of the particle.

[0024] As a further aspect of the present invention, the steps of performing impedance measurement on the standardized sample solvent, analyzing the impedance change of the standardized sample solvent by monitoring the current response at multiple frequencies, evaluating the electrochemical stability and reactivity of the standardized sample solvent, identifying impurities in the standardized sample solvent, and generating a standardized sample solvent impedance measurement result are specifically as follows:

[0025] S301: Based on the dissolution rate measurement result, use an impedance measurement device to monitor and record in real time the current response data of the standardized sample solvent to obtain the current response data;

[0026] S302: Analyze the current response data. By adjusting the potential parameters, analyze the change in the current response of the standardized sample solvent, identify the resistance and capacitance characteristics of the standardized sample solvent, and obtain impedance change data;

[0027] S303: According to the impedance change data, evaluate the electrochemical stability and reactivity of the standardized sample solvent. Combine the resistance and capacitance characteristics of various compounds to identify the impurities in the standardized sample solvent, and obtain the impedance measurement result of the standardized sample solvent.

[0028] As a further solution of the present invention, according to the impedance measurement result of the standardized sample solvent, by measuring the spectral absorption and fluorescence characteristics of the standardized sample solvent, combining the dissolution rate measurement result and the impedance measurement result of the standardized sample solvent, analyze the chemical characteristics of the drug sample, identify the active ingredients in the drug sample, and the steps to obtain the drug sample component identification list are specifically as follows:

[0029] S401: Based on the impedance measurement result of the standardized sample solvent, measure the spectral absorption characteristics of the standardized sample solvent, record the spectral absorption data, and obtain the spectral absorption data;

[0030] S402: Use the spectral absorption data to measure the fluorescence characteristics of the standardized sample solvent and obtain the fluorescence characteristic data;

[0031] S403: Based on the fluorescence characteristic data, combine the dissolution rate of the drug sample, the impedance of the standardized sample solvent, and the spectral absorption data to identify the active ingredients in the drug sample and obtain the drug sample component identification list.

[0032] As a further solution of the present invention, using the drug sample component identification list, by comparing with the drug formula, analyze the consistency of the drug component type and dosage, mark and extract multiple pieces of information of unqualified drugs, and the steps to generate the drug component detection result are specifically as follows:

[0033] S501: Based on the drug sample component identification list, combine the formula information of the drug sample. By comparing the active ingredient and impurity lists, identify the deviated components and obtain the component matching record;

[0034] S502: Analyze the component matching record, analyze and calculate the dosage deviation of various drug components, and obtain the dosage deviation analysis result;

[0035] S503: Use the dosage deviation analysis result to mark the unqualified drug samples and extract the production batch, production date, and manufacturer information of the drugs to obtain the drug component detection result.

[0036] As a further solution of the present invention, the specific formula for analyzing and calculating the dosage deviation of multiple drug components is as follows:

[0037]

[0038] Wherein, represents the measured component content of the th drug sample, represents the theoretical content of this component in the formula, represents the weight based on the importance of the drug sample, represents the weighted dosage deviation value, represents the serial number of the drug sample in the analysis batch.

[0039] On the other hand, a drug component detection system based on basic pharmacy is provided. This system is applied to the drug component detection method based on basic pharmacy. The system includes:

[0040] The measurement drug sample preparation module measures the weight of the drug sample based on the drug sample, adds a solvent for dissolution in combination with a preset ratio, dilutes and mixes, records the color, viscosity, and pH value of the solvent, and generates a standardized sample solvent;

[0041] The dissolution process monitoring module monitors the size and quantity of drug sample particles during the dissolution process of the drug sample based on the standardized sample solvent, evaluates the behavior pattern of the drug sample particles in the standardized sample solvent, and generates a dissolution rate measurement result;

[0042] The electrochemical analysis module measures the impedance of the standardized sample solvent based on the dissolution rate measurement result, monitors the current response at multiple frequencies, analyzes the impedance change of the standardized sample solvent, evaluates the electrochemical stability and reactivity of the standardized sample solvent, identifies impurities in the standardized sample solvent, and generates a standardized sample solvent impedance measurement result;

[0043] The chemical property analysis module measures the spectral absorption and fluorescence properties of the standardized sample solvent based on the standardized sample solvent impedance measurement result, analyzes the chemical properties of the drug sample in combination with the dissolution rate measurement result and the solvent impedance measurement result, identifies the active ingredients in the drug sample, and generates a drug sample component identification list;

[0044] The data comparison module analyzes the consistency of the drug sample component type and dosage by comparing with the drug formula based on the drug sample component identification list, and generates component deviation analysis data;

[0045] The drug screening module marks and extracts multiple information of unqualified drugs based on the component deviation analysis data, including the production batch, production date, and manufacturer, and generates a drug component detection result.

[0046] The beneficial effects brought by the technical solution provided by the embodiments of the present invention at least include:

[0047] By standardizing the drug samples, the measurement baseline is ensured, the result deviation is reduced, the credibility of the data is improved, the changes in particle size and quantity are monitored in real time, the understanding of the dissolution process is enhanced, the impedance change of the drug solution is evaluated by monitoring the current response at multiple frequencies, the analysis of the electrochemical properties is enhanced, impurities are accurately detected, the chemical characteristics data of the drug are provided by combining the determination of spectral absorption and fluorescence characteristics, the composition components of the target drug are identified, and the drug formulation is ensured to meet the specified standards, thereby ensuring the safety and effectiveness of the drug. BRIEF DESCRIPTION OF THE DRAWINGS

[0048] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings required for the description of the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present invention, and those of ordinary skill in the art can also obtain other drawings based on these drawings without creative efforts.

[0049] Figure 1 It is a schematic diagram of the working process of the present invention;

[0050] Figure 2 It is a detailed flowchart of S1 of the present invention;

[0051] Figure 3 It is a detailed flowchart of S2 of the present invention;

[0052] Figure 4 It is a detailed flowchart of S3 of the present invention;

[0053] Figure 5 It is a detailed flowchart of S4 of the present invention;

[0054] Figure 6 It is a detailed flowchart of S5 of the present invention;

[0055] Figure 7 It is a system flowchart of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0056] The technical solutions in the present invention will be described below with reference to the drawings.

[0057] In the embodiments of the present invention, words such as "exemplarily" and "for example" are used to represent examples, illustrations or explanations. Any embodiment or design described as an "example" in the present invention should not be construed as being more preferred or advantageous than other embodiments or designs. Rather, the use of the word "example" is intended to present concepts in a specific manner. In addition, in the embodiments of the present invention, the meaning expressed by "and / or" can be both, or either one of the two can be selected.

[0058] In the embodiments of the present invention, "image" and "picture" can sometimes be used interchangeably. It should be noted that when the difference is not emphasized, the meanings they express are the same. "(of)", "corresponding", and "corresponding" can sometimes be used interchangeably. It should be noted that when the difference is not emphasized, the meanings they express are the same.

[0059] In the embodiments of the present invention, sometimes a subscript such as W1 may be written in a non-subscript form such as W1. When the difference is not emphasized, the meanings they express are the same.

[0060] To make the technical problems, technical solutions and advantages to be solved by the present invention clearer, the following will be described in detail with reference to the accompanying drawings and specific embodiments.

[0061] The embodiments of the present invention provide a method for detecting drug components based on basic pharmacy, as Figure 1 shown in the flowchart of the method for detecting drug components based on basic pharmacy. The processing flow of the method may include the following steps:

[0062] S1: Based on the drug sample, measure the weight of the drug sample, add a solvent for dissolution according to a preset ratio, combine dilution and mixing, record the color, viscosity, and pH value of the solvent, and generate a standardized sample solvent;

[0063] S2: Based on the standardized sample solvent, detect and record in real time the information on the change in the particle size and quantity of the drug sample during the dissolution process of the drug sample, evaluate the behavior pattern of the drug sample particles in the standardized sample solvent, and obtain the dissolution rate measurement result;

[0064] S3: Use the dissolution rate measurement result to perform impedance measurement on the standardized sample solvent. By monitoring the current response at multiple frequencies, analyze the impedance change of the standardized sample solvent, evaluate the electrochemical stability and reactivity of the standardized sample solvent, identify the impurities in the standardized sample solvent, and generate the impedance measurement result of the standardized sample solvent;

[0065] S4: According to the measurement results of the impedance of the standardized sample solvent, by measuring the spectral absorption and fluorescence characteristics of the standardized sample solvent, combining the dissolution rate measurement results and the impedance measurement results of the standardized sample solvent, analyze the chemical characteristics of the drug sample, identify the active ingredients in the drug sample, and obtain a drug sample component identification list;

[0066] S5: Use the drug sample component identification list, by comparing with the drug formula, analyze the consistency of the drug component type and dosage, mark and extract multiple pieces of information of unqualified drugs, and generate drug component detection results.

[0067] The dissolution rate measurement results include the change of the particle size of the drug sample, the time-series change data of the particle number, and the dissolution rate constant of the drug sample. The impedance measurement results of the standardized sample solvent include the impedance values at multiple frequencies, the electrochemical stability rating, and the current response characteristics of the drug sample components. The drug sample component identification list includes the chemical structure, concentration ratio, impurity type, and content information of the drug active ingredients. The drug component detection results include component deviation information, dosage deviation information, and drug information extraction records.

[0068] Please refer to Figure 2 , based on the drug sample, measure the weight of the drug sample, add solvent for dissolution according to a preset ratio, combine dilution and mixing, record the color, viscosity, and pH value of the solvent, and the specific steps for generating the standardized sample solvent are as follows:

[0069] S101: Based on the drug sample, use an electronic scale to measure the mass of the drug sample, record the weight of the drug sample, and generate drug sample weight data;

[0070] In the sub-step S101, the electronic scale uses a pressure sensor to provide stable and accurate weight readings, automatically calibrates the measurement error, adapts to environmental factors such as temperature and humidity changes, ensures the accuracy of the data, and the target data is transmitted and updated to the database in real time by the microprocessor, providing accurate basic information for the calculation of the drug solvent amount. The usage process and data recording of the electronic scale both follow strict standardized operation protocols to ensure the reliability and consistency of the measured weight data.

[0071] S102: Based on the drug sample weight data, calculate the required solvent amount according to the preset ratio information, and dissolve the drug to generate drug sample dissolution results;

[0072] In sub-step S102, the required solvent volume is automatically calculated by the computer system. The calculation is based on the dissolution characteristics of the drug and the preset dissolution ratio, and is executed by quantitative analysis software. The software automatically determines the solvent volume according to the solubility of the substance and the target dissolution concentration. The entire dissolution process is carried out in an environment where the temperature and stirring speed are controllable to optimize the dissolution efficiency. The parameter adjustment and monitoring of the dissolution process are completed by sensors to ensure the continuity and stability of the process. The records of the dissolution results include the solvent type and dissolution time, providing detailed data for the subsequent steps.

[0073] S103: Based on the dissolution results of the drug sample, dilute and mix the drug sample, and record the color, viscosity, and pH value of the drug sample solvent to generate a standardized sample solvent;

[0074] In sub-step S103, the dilution and mixing of the sample are carried out. An automatic diluter is used to precisely control the solvent addition and mixing speed. During the dilution process, a pH meter, spectrophotometer, and rotational viscometer are used to monitor the changes in pH value, color, and viscosity. Each monitored data is automatically recorded in the database, providing comprehensive information about the physical and chemical properties of the sample to ensure the accuracy of the data. After dilution and mixing, the sample is automatically transferred to the next test stage, providing key data support for drug quality control and efficacy testing.

[0075] Please refer to Figure 3 , based on the standardized sample solvent, the steps to detect and record the changes in the particle size and number of the drug sample during the dissolution process of the drug sample in real time, evaluate the behavior pattern of the drug sample particles in the standardized sample solvent, and obtain the dissolution rate measurement results are as follows:

[0076] S201: Based on the standardized sample solvent, monitor and record the change process of the drug sample particles during the dissolution process of the drug sample in real time to generate drug sample particle change monitoring data;

[0077] In sub-step S201, a high-speed camera combined with image analysis software is used to capture the dynamic changes of the particles. The image analysis software accurately measures the size and morphology of each particle through edge detection and particle tracking algorithms. The system is equipped with a laser scattering instrument to evaluate the particle number and distribution. The laser scattering instrument provides detailed data on the particle size distribution by measuring the intensity and angle of the scattered light. The monitoring data is automatically summarized and recorded in the central database, providing real-time updated particle information for subsequent data analysis. The process ensures the integrity and reliability of the data, laying a foundation for further particle behavior analysis.

[0078] S202: Based on the drug sample particle change monitoring data, analyze the particle size and number of the drug sample at multiple time points to generate drug sample particle behavior analysis data;

[0079] In sub-step S202, statistical analysis software is used to deeply analyze the particle change monitoring data. The multi-point time series analysis technique is applied to quantitatively evaluate the changing trends of particle size and quantity. The analysis considers multiple time points. Analysis of variance and regression models are used to identify significant patterns in the changes of particle size and quantity, revealing the dynamic behavior of particles during the dissolution process, including the tendency of particle aggregation or dispersion. The generated particle behavior analysis data records the particle dynamics at each time point, providing a scientific basis for the calculation of the dissolution rate. The analysis results are presented in graphical and tabular forms for easy understanding of the behavior patterns of particles during the dissolution process.

[0080] S203: Based on the particle behavior analysis data of the drug sample, calculate the dissolution rate of the drug sample particles in the standardized sample solvent, analyze and record the behavior patterns of the dissolution of the drug sample particles, and generate the dissolution rate measurement results;

[0081] The specific formula for calculating the dissolution rate of the drug sample particles in the standardized sample solvent is:

[0082]

[0083] Where, represents the dissolution rate, represents the density of the drug sample particles, represents the differential symbol, represents an infinitesimal increment of time, represents the derivative with respect to time, used to calculate the rate of change of the volume of the drug sample particles over time, is the pi, represents the radius of the particle.

[0084] Formula:

[0085]

[0086] Detailed explanation of the formula and the derivation process of the formula calculation:

[0087] The formula is used to calculate the dissolution rate of drug particles, and the rate is used to evaluate the dissolution efficiency of the drug;

[0088] Meaning and set values of parameters:

[0089] is the density of the drug sample particles, assumed to be 1.40 mg per cubic millimeter;

[0090] is the radius of the drug sample particles, assumed to be 0.5 mm;

[0091] is the pi, with a value of 3.14159;

[0092] Represents the rate of radius reduction. Assuming that the radius of the drug particle decreases from 0.5 mm to 0.45 mm within 10 minutes, the rate of change is mm per minute;

[0093] Substitute the parameters directly into the formula for calculation:

[0094] ;

[0095] ;

[0096] ;

[0097] The result of 0.0115 mg / min indicates that under the target experimental conditions, the drug particle is converted from a solid state to a dissolved state at a rate of 0.0115 milligrams per minute. The dissolution rate reflects the dissolution characteristics of the drug and the preparation effect.

[0098] Please refer to Figure 4 , for the steps of impedance measurement of the standardized sample solvent. By monitoring the current response at multiple frequencies, analyzing the impedance change of the standardized sample solvent, evaluating the electrochemical stability and reactivity of the standardized sample solvent, identifying impurities in the standardized sample solvent, and generating the impedance measurement results of the standardized sample solvent, the specific steps are as follows:

[0099] S301: Based on the dissolution rate measurement results, use the impedance measurement device to monitor and record the current response data of the standardized sample solvent in real time to obtain the current response data;

[0100] In the sub-step of S301, an electrochemical workstation is used to capture the current response. Using a current detector and a voltage source to ensure the accuracy and repeatability of the measurement. The recording of the current data is automated and updated to the central monitoring system in real time through software. In the step, the monitoring device continuously tracks the change of the current in the solution, and the system performs self-calibration for each measurement to eliminate device deviation and ensure the reliability of the data. The current response data reflects the electrochemical characteristics of the interaction between the drug and the solvent during the dissolution process, providing key information for further data analysis and interpretation.

[0101] S302: Analyze the current response data. By adjusting the potential parameters, analyze the change of the current response of the standardized sample solvent, identify the resistance and capacitance characteristics of the standardized sample solvent, and obtain the impedance change data;

[0102] In sub-step S302, a current response model is configured through data processing software. Based on the input current data analysis, the resistance and capacitance characteristics of the solution are analyzed. By adjusting the potential parameters, the electrochemical behavior under different conditions is simulated, and the electrical property changes of the solution are identified and evaluated. During the process, step response analysis and spectral analysis methods are adopted. By analyzing the current-voltage curve, the resistance and capacitance values in the solution are determined, and the analysis results are recorded in a detailed report. The target data shows the behavior pattern of the solution in the electrochemical reaction, providing an important perspective on the drug dissolution dynamics.

[0103] S303: According to the impedance change data, evaluate the electrochemical stability and reactivity of the standardized sample solvent. Combine the resistance and capacitance characteristics of various compounds to identify the impurities in the standardized sample solvent, and obtain the impedance measurement results of the standardized sample solvent.

[0104] In sub-step S303, electrochemical impedance spectroscopy analysis technology is adopted. Through impedance measurements at multiple frequency points, the resistance and capacitance characteristics in the solution are comprehensively evaluated to distinguish chemical reactions and impurities. Impedance spectroscopy can reveal the electrochemical stability of the compounds in the solution. Through detailed analysis of the resistance and capacitance characteristics of different compounds, combined with software-assisted data processing and comparison with historical data, the impurity components and concentrations in the solution are accurately identified. The results record the electrochemical behavior of the solution in detail, providing a basis for implementing quality control and improving formulation design.

[0105] Please refer to Figure 5 , according to the impedance measurement results of the standardized sample solvent, by measuring the spectral absorption and fluorescence characteristics of the standardized sample solvent, combining the dissolution rate measurement results and the impedance measurement results of the standardized sample solvent, analyze the chemical characteristics of the drug sample, identify the active ingredients in the drug sample, and the specific steps to obtain the drug sample component identification list are as follows:

[0106] S401: Based on the impedance measurement results of the standardized sample solvent, measure the spectral absorption characteristics of the standardized sample solvent, record the spectral absorption data, and obtain the spectral absorption data.

[0107] In sub-step S401, through a spectrophotometer, the spectral absorption of the drug in the solution is analyzed using spectrophotometry. The absorption spectrum from ultraviolet to visible light range is captured. By precisely controlling the intensity and wavelength of the light source, the spectrophotometer automatically records the absorption rate at each wavelength, generating a continuous absorption spectrum curve. The target spectral data is processed by software to automatically correct background noise and instrument deviation, ensuring the accuracy and repeatability of the data. The obtained spectral absorption data records the absorption characteristics of the drug at different wavelengths, which is crucial for subsequent analysis of the chemical structure and concentration of the drug.

[0108] S402: Using the spectral absorption data, measure the fluorescence characteristics of the standardized sample solvent to obtain fluorescence characteristic data;

[0109] In sub-step S402, the fluorescence spectrometer provides information on the interaction between the structure and environment of drug molecules by exciting the drug molecules in the solution and recording their fluorescence emission. During the measurement process, the instrument excites the solution with light of a specific wavelength, measures the intensity and spectral distribution of the fluorescence emission, and the obtained fluorescence characteristic data is analyzed by software to identify the fluorescence tags of specific drug molecules. The target data provides an accurate scientific basis for determining the presence and state of the active ingredients in the drug.

[0110] S403: Based on the fluorescence characteristic data, combined with the dissolution rate of the drug sample, the impedance of the standardized sample solvent, and the spectral absorption data, identify the active ingredients in the drug sample to obtain a drug sample component identification list;

[0111] In sub-step S403, comprehensive data analysis software is used to identify the active ingredients of the drug. The software uses multi-parameter data fusion technology to integrate data from spectral absorption, fluorescence characteristics, and electrochemical measurements, performs data modeling and analysis, identifies the main and minor active ingredients and impurities in the solution, and the generated sample component identification list records the chemical structure, concentration, and interaction of each component, providing a scientific basis for the quality control and further efficacy evaluation of the drug.

[0112] Please refer to Figure 6 , using the drug sample component identification list, by comparing with the drug formula, analyze the consistency of the drug component type and dosage, mark and extract multiple information of unqualified drugs, and the steps for generating the drug component detection results are specifically as follows:

[0113] S501: Based on the drug sample component identification list, combined with the formula information of the drug sample, by comparing the active ingredient and impurity lists, identify the deviated components to obtain a component matching record;

[0114] In sub-step S501, compare the sample component identification list with the drug formula information to identify the deviation between the active ingredients in the drug and the expected ingredients in the formula. By loading the standard formula database of the drug, the software checks the chemical structure and concentration of each component for matching. During the comparison process, pay attention to the active ingredients and impurity components, accurately identify the components that do not meet the specifications, and the obtained component matching record details the matching status of all components, including the matching components and the deviated components, providing a clear view of the consistency and differences between the sample and the expected formula.

[0115] S502: Analyze the component matching record, analyze and calculate the dosage deviation of multiple drug components to obtain a dosage deviation analysis result;

[0116] The specific formula for analyzing and calculating the dosage deviation of multiple drug components is as follows:

[0117]

[0118] Wherein, represents the measured component content of the th drug sample, represents the theoretical content of this component in the formula, represents the weight based on the importance of the drug sample, represents the weighted dosage deviation value, represents the serial number of the drug sample in the analysis batch.

[0119] Formula:

[0120]

[0121] Detailed explanation of the formula and the derivation process of formula calculation:

[0122] The formula is used to calculate the weighted dosage deviation score of drug components, and the result is used to evaluate the drug quality.

[0123] Meaning and setting values of parameters:

[0124] is the measured component content of the i-th drug sample. Suppose there are 10 samples, and the active ingredient contents of each sample are 95mg, 105mg, 97mg, 102mg, 100mg, 98mg, 103mg, 96mg, 99mg, 104mg in sequence;

[0125] is the theoretical content of the drug component in the formula, supposed to be 100mg;

[0126] is the weight based on the sample importance, supposed to be 1.1, 0.9, 1.0, 1.0, 1.2, 0.8, 1.1, 0.7, 1.0, 0.9 respectively;

[0127] Substitute the parameters into the formula for calculation:

[0128] ;

[0129] ;

[0130] ;

[0131] Result 10.27 shows the weighted dose deviation score, which reflects the deviation degree between the measured content and the theoretical content of drug ingredients. A lower value indicates a higher consistency between the drug ingredient content and the designed formula, while a higher value may indicate certain problems in the production process.

[0132] S503: Use the dose deviation analysis result to mark unqualified drug samples, and extract the production batch, production date, and manufacturer information of the drugs to obtain the drug ingredient detection results;

[0133] In sub-step S503, mark the drug samples that do not meet the specifications, automatically extract and record the detailed information of the target samples through the quality management system, including the production batch, production date, and manufacturer information. The system marks the qualified status of each sample according to the dose deviation analysis result. Unqualified samples will be classified into specific categories and a detailed unqualified report will be generated, providing the necessary data support for subsequent quality audits and product recalls, and providing improvement suggestions and preventive measures according to the specific problems of the unqualified drugs.

[0134] Please refer to Figure 7 , a drug ingredient detection system based on basic pharmacy. The drug ingredient detection system based on basic pharmacy is used to execute the above-mentioned drug ingredient detection method based on basic pharmacy. The system includes:

[0135] The drug sample preparation module for measurement measures the weight of the drug sample based on the drug sample, adds a solvent for dissolution according to a preset ratio, dilutes and mixes, records the color, viscosity, and pH value of the solvent, and generates a standardized sample solvent;

[0136] The dissolution process monitoring module based on the standardized sample solvent monitors the size and quantity of drug sample particles during the dissolution process of the drug sample in real time, evaluates the behavior pattern of the drug sample particles in the standardized sample solvent, and generates a dissolution rate measurement result;

[0137] The electrochemical analysis module based on the dissolution rate measurement result measures the impedance of the standardized sample solvent, monitors the current response at multiple frequencies, analyzes the impedance change of the standardized sample solvent, evaluates the electrochemical stability and reactivity of the standardized sample solvent, identifies impurities in the standardized sample solvent, and generates a standardized sample solvent impedance measurement result;

[0138] The chemical property analysis module based on the standardized sample solvent impedance measurement result measures the spectral absorption and fluorescence properties of the standardized sample solvent, combines the dissolution rate measurement result and the solvent impedance measurement result, analyzes the chemical properties of the drug sample, identifies the active ingredients in the drug sample, and generates a drug sample ingredient identification list;

[0139] The data comparison module analyzes the consistency of the types and dosages of the components in the drug sample by comparing with the drug formula based on the list of identified components of the drug sample, and generates component deviation analysis data.

[0140] Based on the component deviation analysis data, the drug screening module marks and extracts multiple pieces of information of unqualified drugs, including production batches, production dates, and manufacturers, and generates drug component test results.

[0141] The above embodiments can be implemented in whole or in part by software, hardware (such as circuits), firmware, or any other combination. When implemented using software, the above embodiments can be implemented in whole or in part in the form of a computer program product. The computer program product includes one or more computer instructions or computer programs. When the computer instructions or computer programs are loaded or executed on a computer, the processes or functions described in the embodiments of the present invention are generated in whole or in part. The computer can be a general-purpose computer, a special-purpose computer, a computer network, or other programmable devices. The computer instructions can be stored in a computer-readable storage medium, or transmitted from one computer-readable storage medium to another. For example, the computer instructions can be transmitted from one website, computer, server, or data center to another website, computer, server, or data center by wired (such as infrared, wireless, microwave, etc.) means. The computer-readable storage medium can be any available medium that the computer can access, or a data storage device such as a server or data center that contains one or more collections of available media. The available media can be magnetic media (such as floppy disks, hard disks, magnetic tapes), optical media (such as DVDs), or semiconductor media. The semiconductor media can be a solid-state drive.

[0142] It should be understood that the term "and / or" in this article is merely a description of the association relationship between associated objects, indicating that there can be three relationships. For example, A and / or B can represent: A exists alone, A and B exist simultaneously, and B exists alone. Here, A and B can be singular or plural. In addition, the character " / " in this article generally represents an "or" relationship between the associated objects before and after, but it may also represent an "and / or" relationship, which can be specifically understood with reference to the context before and after.

[0143] In the present invention, "at least one" means one or more, and "multiple" means two or more. "At least one of the following" or its similar expressions refer to any combination of these items, including any combination of single items or plural items. For example, at least one of a, b, or c can represent: a, b, c, a - b, a - c, b - c, or a - b - c, where a, b, and c can be single or multiple.

[0144] It should be understood that in various embodiments of the present invention, the magnitudes of the serial numbers of the above processes do not imply the order of execution, and the order of execution of each process should be determined by its function and internal logic, and should not constitute any limitation to the implementation process of the embodiments of the present invention.

[0145] Those of ordinary skill in the art can realize that the units and algorithm steps of each example described in combination with the embodiments disclosed herein can be implemented by electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are executed in a hardware or software manner depends on the specific application and design constraints of the technical solution. Professional technicians can use different methods to implement the described functions for each specific application, but such implementation should not be considered to exceed the scope of the present invention.

[0146] Those skilled in the art can clearly understand that for the convenience and brevity of description, the specific working processes of the devices, apparatuses, and units described above can refer to the corresponding processes in the foregoing method embodiments, and will not be repeated here.

[0147] In several embodiments provided by the present invention, it should be understood that the disclosed devices, apparatuses, and methods can be implemented in other ways. For example, the device embodiments described above are merely illustrative. For example, the division of the units is only a logical function division, and there can be other division methods in actual implementation. For example, multiple units or components can be combined or integrated into another device, or some features can be ignored or not executed. Another point is that the displayed or discussed couplings or direct couplings or communication connections to each other can be through some interfaces, and the indirect couplings or communication connections of the devices or units can be in an electrical, mechanical, or other form.

[0148] The units described as separate components may or may not be physically separated, and the components displayed as units may or may not be physical units, that is, they can be located in one place, or distributed to multiple network units. Some or all of the units can be selected according to actual needs to achieve the purpose of the solution of this embodiment.

[0149] In addition, the functional units in various embodiments of the present invention can be integrated into one processing unit, or each unit can exist physically alone, or two or more units can be integrated into one unit.

[0150] When the above-mentioned function is implemented in the form of a software functional unit and sold or used as an independent product, it can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present invention, in essence, or the part that contributes to the prior art, or a part of this technical solution, can be embodied in the form of a software product. This computer software product is stored in a storage medium and includes several instructions for causing a computer device (which may be a personal computer, a server, or a network device, etc.) to execute all or part of the steps of the methods described in various embodiments of the present invention. The aforementioned storage medium includes: various media that can store program codes, such as USB flash drives, mobile hard disks, read-only memory (ROM), random access memory (RAM), magnetic disks, or optical discs.

[0151] As described above, the above are only specific embodiments of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art within the technical scope disclosed by the present invention can easily think of changes or substitutions, which should all be covered by the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

1. A drug component detection method based on basic pharmacy, characterized in that: The method comprises: Based on the drug sample, measure the weight of the drug sample, add solvent to dissolve it according to the preset ratio, combine dilution and mixing, record the color, viscosity, and pH value of the solvent, and generate a standardized sample solvent; Based on the standardized sample solvent, real-time detection and recording of the change information of the size and quantity of the drug sample particles during the dissolution process of the drug sample, evaluating the behavior pattern of the drug sample particles in the standardized sample solvent, and obtaining the dissolution rate measurement result; Using the dissolution rate measurement results, impedance measurement of the standardized sample solvent is performed, and by monitoring the current response at multiple frequencies, the impedance change of the standardized sample solvent is analyzed, the electrochemical stability and reactivity of the standardized sample solvent are evaluated, impurities in the standardized sample solvent are identified, and the standardized sample solvent impedance measurement results are generated; The specific steps are: Based on the dissolution rate measurement results, using an impedance measurement device to monitor and record the current response data of the standardized sample solvent in real time to obtain current response data; Analyzing the current response data, analyzing the current response change of the standardized sample solvent by adjusting the potential parameters, identifying the resistance and capacitance characteristics of the standardized sample solvent, and obtaining impedance change data; According to the impedance change data, the electrochemical stability and reactivity of the standardized sample solvent are evaluated, and the impurities in the standardized sample solvent are identified by combining the resistance and capacitance characteristics of the various compounds to obtain the impedance measurement results of the standardized sample solvent; According to the standardized sample solvent impedance measurement results, by measuring the spectral absorption and fluorescence characteristics of the standardized sample solvent, combining the dissolution rate measurement results and the standardized sample solvent impedance measurement results, analyzing the chemical characteristics of the drug sample, identifying the active ingredients in the drug sample, and obtaining a drug sample component identification list; The specific steps are: Based on the standardized sample solvent impedance measurement result, measuring the spectral absorption characteristics of the standardized sample solvent, recording the spectral absorption data, and obtaining the spectral absorption data; Using the spectral absorption data, the fluorescence characteristics of the standardized sample solvent are measured to obtain fluorescence characteristic data; Based on the fluorescence characteristic data, combined with the dissolution rate of the drug sample, the impedance of the standardized sample solvent and the spectral absorption data, the active ingredients in the drug sample are identified to obtain a drug sample component identification list; By using the drug sample ingredient identification list and comparing it with the drug formula, the consistency of drug ingredient type and dosage is analyzed, multiple information of unqualified drugs is marked and extracted, and drug ingredient detection results are generated.

2. The drug component detection method based on basic pharmacy according to claim 1, characterized in that: The dissolution rate measurement results include changes in the particle size of drug samples, time series change data on the number of particles, and drug sample dissolution kinetic rate constants. The standardized sample solvent impedance measurement results include impedance values ​​at multiple frequencies, electrochemical stability ratings, and current response characteristics of drug sample components. The drug sample component identification list includes the chemical structure, concentration ratio, impurity type and content information of the active ingredients of the drug. The drug component detection results include component deviation information, dosage deviation information, and drug information extraction records.

3. The drug component detection method based on basic pharmacy according to claim 1, characterized in that: Based on the drug sample, the weight of the drug sample is measured, and the solvent is added to dissolve it according to the preset ratio. Combined with dilution and mixing, the color, viscosity, and pH value of the solvent are recorded. The specific steps for generating a standardized sample solvent are as follows: Based on the drug samples, the weight of the drug samples is measured using an electronic scale, the weight of the drug samples is recorded, and the weight data of the drug samples is generated; Based on the drug sample weight data and preset ratio information, the required amount of solvent is calculated, and the drug is dissolved to generate a drug sample dissolution result; Based on the drug sample dissolution result, the drug sample is diluted and mixed, and the color, viscosity and pH value of the drug sample solvent are recorded to generate a standardized sample solvent.

4. The drug component detection method based on basic pharmacy according to claim 1, characterized in that: Based on the standardized sample solvent, the steps of real-time detecting and recording the change information of the size and quantity of the drug sample particles during the dissolution process of the drug sample, evaluating the behavior pattern of the drug sample particles in the standardized sample solvent, and obtaining the dissolution rate measurement result are specifically as follows: Based on the standardized sample solvent, real-time monitoring and recording of the change process of the drug sample particles during the dissolution of the drug sample, and generating drug sample particle change monitoring data; Based on the drug sample particle change monitoring data, analyzing the size and quantity of drug sample particles at multiple time points to generate drug sample particle behavior analysis data; Based on the drug sample particle behavior analysis data, the dissolution rate of the drug sample particles in the standardized sample solvent is calculated, the behavior pattern of the drug sample particle dissolution is analyzed and recorded, and the dissolution rate measurement result is generated.

5. The drug component detection method based on basic pharmacy according to claim 4, characterized in that: The specific formula for calculating the dissolution rate of the drug sample particles in the standardized sample solvent is: in, represents the dissolution rate, represents the density of drug sample particles, represents the differential symbol, represents infinitesimal increments of time, Represents the derivative with respect to time, which is used to calculate the rate of change of the volume of drug sample particles over time. is pi, Represents the radius of the particle.

6. The drug component detection method based on basic pharmacy according to claim 1, characterized in that: The steps of using the drug sample component identification list, comparing with the drug formula, analyzing the consistency of drug component type and dosage, marking and extracting multiple information of unqualified drugs, and generating drug component test results are as follows: Based on the drug sample component identification list and in combination with the drug sample formula information, by comparing the active ingredient and impurity lists, the deviation components are identified to obtain a component matching record; Analyze the component matching records, analyze and calculate the dosage deviations of multiple drug components, and obtain dosage deviation analysis results; The dosage deviation analysis results are used to mark unqualified drug samples, and the production batch, production date, and manufacturer information of the drugs are extracted to obtain drug ingredient detection results.

7. The drug component detection method based on basic pharmacy according to claim 6, characterized in that: The specific formula for analyzing and calculating the dosage deviation of multiple drug components is: in, Representative The actual measured content of ingredients in each drug sample, Represents the theoretical content of the ingredient in the formula. represents the weight based on the importance of drug samples, represents the weighted dose deviation value, Indicates the serial number of the drug sample in the analysis batch.

8. A drug component detection system based on basic pharmacy, characterized in that: According to any one of claims 1 to 7, the drug component detection method based on basic pharmacy comprises: The drug sample preparation module measures the weight of the drug sample based on the drug sample, adds solvent in a preset proportion to dissolve it, records the color, viscosity, and pH value of the solvent through dilution and mixing, and generates a standardized sample solvent; The dissolution process monitoring module monitors the size and quantity of drug sample particles in the drug sample dissolution process in real time based on the standardized sample solvent, evaluates the behavior pattern of drug sample particles in the standardized sample solvent, and generates a dissolution rate measurement result; The electrochemical analysis module performs impedance measurement of the standardized sample solvent based on the dissolution rate measurement result, monitors the current response at multiple frequencies, analyzes the impedance change of the standardized sample solvent, evaluates the electrochemical stability and reactivity of the standardized sample solvent, identifies impurities in the standardized sample solvent, and generates the impedance measurement result of the standardized sample solvent; The chemical property analysis module measures the spectral absorption and fluorescence properties of the standardized sample solvent based on the standardized sample solvent impedance measurement results, analyzes the chemical properties of the drug sample in combination with the dissolution rate measurement results and the solvent impedance measurement results, identifies the active ingredients in the drug sample, and generates a drug sample component identification list; The data comparison module analyzes the consistency of the drug sample component type and dosage based on the drug sample component identification list and compares it with the drug formula to generate component deviation analysis data; The drug screening module marks and extracts multiple pieces of information of unqualified drugs based on the ingredient deviation analysis data, including production batch, production date, and manufacturer, and generates drug ingredient detection results.

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