Basic pharmacy-based drug component detection method and system

Abstract

The invention relates to the technical field of medicine analysis, in particular to a medicine component detection method and system based on basic pharmacy, and the method comprises the following steps: detecting a medicine sample, measuring the weight of the medicine sample, adding a solvent according to a preset proportion for dissolving, combining dilution and mixing, and recording the color, viscosity and ph value of the solution, and generating a standardized sample solvent. According to the invention, standardization processing is carried out on a drug sample, a measurement base line is ensured, result deviation is reduced, data credibility is improved, particle size and quantity changes are monitored in real time, understanding of a dissolution process is improved, and analysis of electrochemical properties is enhanced by monitoring current response and evaluating impedance changes of a drug solution under various frequencies. Impurities are accurately detected, spectral absorption and fluorescence characteristic determination are combined, chemical characteristic data of drugs are provided, components of target drugs are recognized, it is ensured that the formula of the drugs meets the specified standard, and the safety and effectiveness of the drugs are guaranteed.

Description

Technical Field

[0001] The present invention relates to the technical field of drug analysis, and in particular to a drug component detection method and system based on basic pharmacy. Background Art

[0002] The field of pharmaceutical analysis technology focuses on using a variety of chemical, biochemical and physical methods to quantitatively and qualitatively analyze active ingredients and impurities in drugs and biologics to ensure 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 and various key quality parameters, including dissolution rate and stability, are evaluated. Pharmaceutical analysis is crucial to drug development, production process control, product testing and regulatory compliance, ensuring patient medication safety.

[0003] Among them, the drug ingredient detection method is designed to identify and quantify the active ingredients and impurities in drugs, ensure the quality and safety of drugs during production and use, and accurately determine the ingredients in drugs, confirm the active ingredients and concentrations in drugs through qualitative and quantitative analysis, and monitor the presence of impurities and degradation products, effectively avoid contamination and inconsistency in raw materials and products, and protect patients from inferior drugs. Drug ingredient detection is a key link in the process of drug registration, market access, and regulatory approval. It is of great significance to the research and development and quality control of drugs, effectively preventing unqualified drugs from entering the market and ensuring public health and safety.

[0004] Traditional drug ingredient testing methods require complex sample preparation and long analysis times, leading to delays in production environments where quality control decisions need to be made quickly. When faced with complex drug samples, they are not sensitive enough or cannot provide sufficient quantitative data when detecting low-concentration impurities or ingredients that are not clearly labeled in the drug formula, making it difficult to fully evaluate the safety and efficacy of drugs. As a result, quality problems in drug production are not identified in a timely manner, increasing the risk of substandard 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 in the prior art, the embodiment of the present invention provides a drug component detection method and system based on basic pharmacy. The technical solution is as follows:

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

[0007] S1: Based on the detection of drug samples, the weight of the drug samples is measured, and solvent is added to dissolve according to the preset ratio. Combined with dilution and mixing, the color, viscosity, and pH value of the solution are recorded to generate a standardized sample solvent;

[0008] S2: Based on the standardized sample solvent, real-time detection and recording of particle size and quantity change information during drug dissolution process, evaluation of particle behavior pattern in solution, and obtaining dissolution rate measurement results;

[0009] S3: using the dissolution rate measurement results, performing impedance measurement of the drug solution, analyzing impedance changes of drug components by monitoring current responses at multiple frequencies, evaluating electrochemical stability and reactivity of the solution, identifying impurities in the solution, and generating solution impedance measurement results;

[0010] S4: According to the solution impedance measurement results, by measuring the spectral absorption and fluorescence characteristics of the drug solution, combining the drug dissolution rate and solution impedance, analyzing the chemical characteristics of the drug, identifying the active ingredients in the drug, and obtaining a sample component identification list;

[0011] S5: Using the sample component identification list, by 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 detection results.

[0012] As a further scheme of the present invention, the standardized sample solvent generation result includes sample quality information, solvent color information, and solvent viscosity data; the dissolution rate measurement result includes particle size change, time series change data of particle number, and sample dissolution kinetic rate constant; the solution impedance measurement result includes impedance values ​​at multiple frequencies, electrochemical stability ratings, and current response characteristics of drug ingredients; the sample component identification list includes the chemical structure, concentration ratio, impurity type and content information of the active ingredient of the drug; 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 detecting drug samples, measuring the weight of the drug samples, adding solvent to dissolve them according to a preset ratio, combining dilution and mixing, and recording the color, viscosity, and pH value of the solution, the steps of generating a standardized sample solvent are specifically as follows:

[0014] S101: Based on the detection of drug samples, the drug quality is measured using an electronic scale, the sample weight is recorded, and drug weight data is generated;

[0015] S102: Based on the drug weight data and preset ratio information, the required amount of solvent is calculated, and the drug is dissolved to generate a sample dissolution result;

[0016] S103: Based on the sample dissolution result, the sample is diluted and mixed, and the color, viscosity and pH value of the drug sample solution are recorded to generate a standardized sample solution.

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

[0018] S201: Based on the standardized sample solution, real-time monitoring and recording of the change process of drug particles during drug dissolution, and generating particle change monitoring data;

[0019] S202: Analyze the particle size and quantity at multiple time points based on the particle change monitoring data to generate particle behavior analysis data;

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

[0021] As a further embodiment of the present invention, the specific formula for calculating the dissolution rate of particles in the solution is:

[0022]

[0023] Among them, R d represents the dissolution rate, ρ represents the density of drug particles, d represents the differential sign, and dt represents the infinitesimal increment of time. It represents the derivative with respect to time and is used to calculate the rate of change of particle volume over time. π is the circumference of a circle and r represents the radius of the particle.

[0024] As a further solution of the present invention, the dissolution rate measurement result is used to perform impedance measurement of the drug solution, and by monitoring the current response at multiple frequencies, the impedance change of the drug components is analyzed, the electrochemical stability and reactivity of the solution are evaluated, and the impurities in the solution are identified. The steps of generating the solution impedance measurement result are specifically as follows:

[0025] S301: Based on the dissolution rate measurement result, using an impedance measurement device, real-time monitoring and recording current response data of the solution to obtain current response data;

[0026] S302: analyzing the current response data, analyzing the current response change of the solution by adjusting the potential parameters, identifying the resistance and capacitance characteristics of the solution, and obtaining impedance change data;

[0027] S303: Evaluate the electrochemical stability and reactivity of the solution according to the impedance change data, identify impurities in the solution in combination with the resistance and capacitance characteristics of the various compounds, and obtain a solution impedance measurement result.

[0028] As a further solution of the present invention, according to the solution impedance measurement results, by measuring the spectral absorption and fluorescence characteristics of the drug solution, combining the dissolution rate of the drug and the solution impedance, analyzing the chemical characteristics of the drug, identifying the active ingredients in the drug, and obtaining the sample component identification list are specifically as follows:

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

[0030] S402: Using the spectral absorption data, measuring the fluorescence characteristics of the drug solution to obtain fluorescence characteristic data;

[0031] S403: Based on the fluorescence characteristic data, combined with the dissolution rate of the drug, the impedance of the solution and the spectral characteristics, the active ingredients in the drug are identified to obtain a sample component identification list.

[0032] As a further solution of the present invention, the sample component identification list is used to compare with the drug formula to analyze the consistency of drug component type and dosage, mark and extract multiple information of unqualified drugs, and generate drug component detection results in the following steps:

[0033] S501: Based on the sample component identification list and in combination with the formula information of the sample medicine, the deviation components are identified by comparing the active ingredient and impurity lists to obtain a component matching record;

[0034] S502: Analyze the component matching records, analyze and calculate the dosage deviations of multiple drug components, and obtain dosage deviation analysis results;

[0035] S503: Using the dosage deviation analysis results, unqualified drug samples are marked, and the production batch, production date, and manufacturer information of the drugs are extracted to obtain drug ingredient detection results.

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

[0037]

[0038] Among them, x i represents the measured content of the ingredient in the i-th drug sample, μ represents the theoretical content of the ingredient in the formula, and w i represents the weight based on the importance of the sample, K represents the weighted dose deviation value, and i represents the sequence number of the sample in the analysis batch.

[0039] On the other hand, a drug component detection system based on basic pharmacy is provided, the system is applied to a drug component detection method based on basic pharmacy, and the system comprises:

[0040] The sample preparation module measures the weight of the sample based on the drug sample to be tested, adds solvent in a preset ratio to dissolve it, and records the color, viscosity, and pH value of the solution through dilution and mixing to generate a standardized sample solution.

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

[0042] The electrochemical analysis module performs impedance measurement of the drug solution based on the dissolution rate measurement results, monitors the current response at multiple frequencies, analyzes the impedance changes of the drug components, evaluates the electrochemical stability and reactivity of the solution, identifies impurities in the solution, and generates solution impedance measurement results;

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

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

[0045] The drug screening module marks unqualified drugs based on the ingredient deviation analysis data, and extracts multiple key information of the target samples, including production batch, production date, and manufacturer, to generate drug ingredient detection results.

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

[0047] By standardizing drug samples, ensuring the measurement baseline, reducing result deviation, and improving data credibility, the changes in particle size and number are monitored in real time, which improves the understanding of the dissolution process. By monitoring the current response at multiple frequencies, the impedance changes of drug solutions are evaluated, the analysis of electrochemical properties is enhanced, and impurities are accurately detected. Combined with the determination of spectral absorption and fluorescence characteristics, data on drug chemical properties is provided, the components of target drugs 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 following briefly introduces the drawings required for use in the description of the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

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

[0050] Figure 2 This is a detailed flow chart of S1 of the present invention;

[0051] Figure 3 This is a detailed flow chart of S2 of the present invention;

[0052] Figure 4 This is a detailed flow chart of S3 of the present invention;

[0053] Figure 5 This is a detailed flow chart of S4 of the present invention;

[0054] Figure 6 This is a detailed flow chart of S5 of the present invention;

[0055] Figure 7 It is a system flow chart of the present invention. DETAILED DESCRIPTION

[0056] The technical solution of the present invention is described below in conjunction with the accompanying drawings.

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

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

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

[0060] In order to make the technical problems, technical solutions and advantages to be solved by the present invention more clear, a detailed description will be given below with reference to the accompanying drawings and specific embodiments.

[0061] The present invention provides a method for detecting drug components based on basic pharmacy. Figure 1 The flowchart of the drug component detection method based on basic pharmacy shown in the figure may include the following steps:

[0062] S1: Based on the detection of drug samples, the weight of the drug samples is measured, and solvent is added to dissolve according to the preset ratio. Combined with dilution and mixing, the color, viscosity, and pH value of the solution are recorded to generate a standardized sample solvent;

[0063] S2: Based on standardized sample solvents, real-time detection and recording of particle size and quantity changes during drug dissolution, evaluation of particle behavior in solution, and dissolution rate measurement results are obtained;

[0064] S3: Using the dissolution rate measurement results, the impedance measurement of the drug solution is performed. By monitoring the current response at multiple frequencies, the impedance changes of the drug components are analyzed, the electrochemical stability and reactivity of the solution are evaluated, the impurities in the solution are identified, and the solution impedance measurement results are generated;

[0065] S4: According to the solution impedance measurement results, by measuring the spectral absorption and fluorescence characteristics of the drug solution, combining the drug dissolution rate and solution impedance, analyzing the chemical properties of the drug, identifying the active ingredients in the drug, and obtaining a sample component identification list;

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

[0067] The results of standardized sample solvent generation include sample quality information, solvent color information, and solvent viscosity data. The dissolution rate measurement results include particle size changes, time series change data of particle number, and sample dissolution kinetic rate constant. The solution impedance measurement results include impedance values ​​at multiple frequencies, electrochemical stability ratings, and current response characteristics of drug ingredients. The 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.

[0068] See also Figure 2 Based on the detection of drug samples, the weight of the drug samples is measured, and the solvent is added to dissolve according to the preset ratio. Combined with dilution and mixing, the color, viscosity, and pH value of the solution are recorded. The specific steps for generating a standardized sample solvent are as follows:

[0069] S101: Based on the detection of drug samples, the drug quality is measured using an electronic scale, the sample weight is recorded, and drug weight data is generated;

[0070] In sub-step S101, the electronic scale uses a pressure sensor to provide stable and accurate weight readings, and automatically calibrates measurement errors to adapt to environmental factors such as changes in temperature and humidity to ensure data accuracy. The target data is transmitted in real time through a microprocessor and updated to the database, providing accurate basic information for calculating the solvent volume of the drug. The use process and data recording of the electronic scale follow strict standardized operating protocols to ensure the reliability and consistency of the measured weight data.

[0071] S102: Based on the drug weight data and preset ratio information, the required amount of solvent is calculated, and the drug is dissolved to generate a sample dissolution result;

[0072] In sub-step S102, the required amount of solvent is automatically calculated by the computer system. The calculation is based on the solubility characteristics of the drug and the preset solubility ratio and is executed by quantitative analysis software. The software automatically determines the solvent volume based on the solubility of the substance and the target solubility concentration. The entire dissolution process is carried out in an environment with controllable temperature and stirring speed 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 dissolution results are recorded including the solvent type and dissolution time, providing detailed data for subsequent steps.

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

[0074] In sub-step S103, the sample was diluted and mixed, and an automatic diluter was used to accurately control the solvent addition and mixing speed. During the dilution process, a pH meter, spectrophotometer and rotational viscometer were used to monitor changes in pH, color and viscosity. Each monitoring data was automatically recorded in the database, providing comprehensive information about the physical and chemical properties of the sample to ensure data accuracy. After dilution and mixing, the sample was automatically transferred to the next testing stage, providing key data support for drug quality control and efficacy testing.

[0075] See also Figure 3 Based on the standardized sample solvent, the particle size and quantity changes during the drug dissolution process are detected and recorded in real time, the behavior pattern of the particles in the solution is evaluated, and the steps to obtain the dissolution rate measurement results are as follows:

[0076] S201: Based on the standardized sample solution, real-time monitoring and recording of the change process of drug particles during drug dissolution process, and generating 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 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 scatterer to evaluate the number and distribution of particles. The laser scatterer provides detailed data on particle size distribution by measuring the intensity and angle of 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 and lays the foundation for further particle behavior analysis.

[0078] S202: Analyze the particle size and quantity at multiple time points based on the particle change monitoring data to generate particle behavior analysis data;

[0079] In sub-step S202, statistical analysis software is used to conduct an in-depth analysis of the particle change monitoring data, and multi-point time series analysis technology is applied to quantitatively evaluate the changing trends of particle size and quantity. The analysis takes into account multiple time points, and variance analysis and regression models are used to identify significant patterns of changes in particle size and quantity, revealing the behavior dynamics of particles during the dissolution process, including the tendency of particles to aggregate or disperse. The generated particle behavior analysis data records the particle dynamics at each time point, providing a scientific basis for the calculation of dissolution rate. The analysis results are presented in graphical and tabular forms to facilitate understanding of the behavior patterns of particles during the dissolution process.

[0080] S203: Based on the particle behavior analysis data, calculate the dissolution rate of the particles in the solution, analyze and record the behavior pattern of the target sample particle dissolution, and generate a dissolution rate measurement result;

[0081] The specific formula for calculating the dissolution rate of particles in solution is:

[0082]

[0083] Among them, R d represents the dissolution rate, ρ represents the density of drug particles, d represents the differential sign, and dt represents the infinitesimal increment of time. It represents the derivative with respect to time and is used to calculate the rate of change of particle volume over time. π is the circumference of a circle and r represents the radius of the particle.

[0084] formula:

[0085]

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

[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] Parameter meaning and setting value:

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

[0090] r is the radius of the drug particle, assumed to be 0.5 mm;

[0091] π is the ratio of the circumference of a circle to its circumference, and its value is 3.14159;

[0092] It represents the rate of radius reduction. Assume that the radius of the drug particle decreases from 0.5 mm to 0.45 mm within 10 minutes, and the rate of change is 0.005 mm per minute;

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

[0094]

[0095]

[0096] R d =0.0115mg / min;

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

[0098] See also Figure 4 , using the dissolution rate measurement results, the impedance measurement of the drug solution is performed. By monitoring the current response at multiple frequencies, the impedance changes of the drug components are analyzed, the electrochemical stability and reactivity of the solution are evaluated, and the impurities in the solution are identified. The specific steps for generating the solution impedance measurement results are as follows:

[0099] S301: Based on the dissolution rate measurement result, using an impedance measurement device, real-time monitoring and recording current response data of the solution to obtain current response data;

[0100] In sub-step S301, an electrochemical workstation is used to capture the current response, and a current detector and a voltage source are used to ensure the accuracy and repeatability of the measurement. The recording of current data is automated and updated to the central monitoring system in real time through software. The monitoring equipment in the step continuously tracks the changes in current in the solution. Each measurement will perform a system self-calibration to eliminate equipment deviations and ensure data reliability. 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: analyzing the current response data, analyzing the current response change of the solution by adjusting the potential parameters, identifying the resistance and capacitance characteristics of the solution, and obtaining impedance change data;

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

[0103] S303: Evaluate the electrochemical stability and reactivity of the solution based on the impedance change data, identify impurities in the solution by combining the resistance and capacitance characteristics of multiple compounds, and obtain the solution impedance measurement result;

[0104] In sub-step S303, electrochemical impedance spectroscopy analysis technology is used to comprehensively evaluate the resistance and capacitance characteristics of the solution through multi-frequency impedance measurement to identify chemical reactions and impurities. Impedance spectroscopy analysis can reveal the electrochemical stability of compounds in the solution, and conduct a detailed analysis of the resistance and capacitance characteristics of different compounds. Through software-assisted data processing and historical data comparison, the impurity components and concentrations in the solution can be 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] See also Figure 5 According to the solution impedance measurement results, the spectral absorption and fluorescence characteristics of the drug solution are measured, and the chemical characteristics of the drug are analyzed in combination with the drug dissolution rate and solution impedance to identify the active ingredients in the drug. The specific steps for obtaining the sample component identification list are as follows:

[0106] S401: Based on the solution impedance measurement result, measure the spectral absorption characteristics of the drug solution, record the spectral data, and obtain spectral absorption data;

[0107] In sub-step S401, the spectral absorption of the drug in the solution is analyzed by spectrophotometry through a spectrum analyzer to capture the absorption spectrum from ultraviolet to visible light. By precisely controlling the intensity and wavelength of the light source, the spectrometer automatically records the absorbance at each wavelength and generates a continuous absorption spectrum curve. The target spectrum data is processed by software to automatically correct background noise and instrument deviation to ensure data accuracy and repeatability. 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, measuring the fluorescence characteristics of the drug solution to obtain fluorescence characteristic data;

[0109] In sub-step S402, the fluorescence spectrometer provides information about the interaction between the drug molecular structure and the environment 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 and measures the intensity and spectral distribution of the fluorescence emission. The obtained fluorescence characteristic data is analyzed by software to identify the fluorescent tags of specific drug molecules. The target data provides an accurate scientific basis for determining the presence and status of active ingredients in the drug.

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

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

[0112] See also Figure 6 , using the sample ingredient identification list, by comparing with the drug formula, analyzing the consistency of drug ingredient type and dosage, marking and extracting multiple information of unqualified drugs, and generating drug ingredient test results in the following steps:

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

[0114] In sub-step S501, the sample ingredient identification list is compared with the drug formula information to identify deviations 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 performs a matching check on the chemical structure and concentration of each ingredient. During the comparison process, attention is paid to the active ingredients and impurity ingredients, and ingredients that do not meet the specifications are accurately identified. The resulting ingredient matching record lists in detail the matching status of all ingredients, including matched ingredients and deviated ingredients, providing a clear view of the consistency and differences between the sample and the expected formula.

[0115] S502: Analyze component matching records, analyze and calculate dosage deviations of multiple drug components, and obtain dosage deviation analysis results;

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

[0117]

[0118] Among them, x i represents the measured content of the ingredient in the i-th drug sample, μ represents the theoretical content of the ingredient in the formula, and w i represents the weight based on the importance of the sample, K represents the weighted dose deviation value, and i represents the sequence number of the sample in the analysis batch.

[0119] formula:

[0120]

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

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

[0123] Parameter meaning and setting value:

[0124] x i is the measured ingredient content of the i-th drug sample. Assume that there are 10 samples, and the active ingredient content of each sample is 95 mg, 105 mg, 97 mg, 102 mg, 100 mg, 98 mg, 103 mg, 96 mg, 99 mg, and 104 mg respectively;

[0125] μ is the theoretical content of the drug ingredient in the formula, assumed to be 100 mg;

[0126] w i are weights based on sample importance, assumed to be 1.1, 0.9, 1.0, 1.0, 1.2, 0.8, 1.1, 0.7, 1.0, and 0.9 respectively;

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

[0128]

[0129]

[0130]

[0131] The result 10.27 indicates the weighted dosage deviation score, which reflects the degree of deviation between the measured content and the theoretical content of the drug ingredients. A lower value indicates that the drug ingredient content is more consistent with the designed formula, otherwise it may indicate certain problems in the production process.

[0132] S503: Using the dosage deviation analysis results, marking unqualified drug samples, and extracting the production batch, production date, and manufacturer information of the drugs to obtain drug ingredient test results;

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

[0134] See also Figure 7 A drug component detection system based on basic pharmacy is used to perform the drug component detection method based on basic pharmacy. The system includes:

[0135] The sample preparation module measures the weight of the sample based on the drug sample to be tested, adds solvent in a preset ratio to dissolve it, and records the color, viscosity, and pH value of the solution through dilution and mixing to generate a standardized sample solution.

[0136] The dissolution process monitoring module monitors the size and number of particles in the drug dissolution process in real time based on standardized sample solutions, evaluates the behavior pattern of particles in the solution, and generates dissolution rate measurement results;

[0137] Based on the dissolution rate measurement results, the electrochemical analysis module performs impedance measurement of the drug solution, monitors the current response at multiple frequencies, analyzes the impedance changes of the drug components, evaluates the electrochemical stability and reactivity of the solution, identifies impurities in the solution, and generates solution impedance measurement results;

[0138] The chemical property analysis module measures the spectral absorption and fluorescence properties of the drug solution based on the solution impedance measurement results. It combines the drug dissolution rate and solution impedance to analyze the chemical properties of the drug, identify the active ingredients in the drug, and generate a sample component identification list.

[0139] The data comparison module analyzes the consistency of drug sample ingredient type and dosage based on the sample ingredient identification list and generates ingredient deviation analysis data by comparing it with the drug formula;

[0140] The drug screening module marks unqualified drugs based on ingredient deviation analysis data, and extracts multiple key information of the target samples, including production batch, production date, and manufacturer, to generate drug ingredient 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 by 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 process or function described in the embodiment of the present invention is generated in whole or in part. The computer can be a general-purpose computer, a special-purpose computer, a computer network, or other programmable device. The computer instructions can be stored in a computer-readable storage medium, or transmitted from one computer-readable storage medium to another computer-readable storage medium. 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.). The computer-readable storage medium can be any available medium that can be accessed by a computer or a data storage device such as a server or data center that contains one or more available media sets. The available medium can be a magnetic medium (for example, a floppy disk, a hard disk, a tape), an optical medium (for example, a DVD), or a semiconductor medium. The semiconductor medium can be a solid-state hard disk.

[0142] It should be understood that the term "and / or" in this article is only a description of the association relationship of associated objects, indicating that there can be three relationships. For example, A and / or B can represent: A exists alone, A and B exist at the same time, and B exists alone. A and B can be singular or plural. In addition, the character " / " in this article generally indicates that the associated objects before and after are in an "or" relationship, but it may also indicate an "and / or" relationship. Please refer to the context for specific understanding.

[0143] In the present invention, "at least one" means one or more, and "more than one" means two or more. "At least one of the following" or similar expressions refers to any combination of these items, including any combination of single or plural items. For example, at least one of a, b, or c can be represented by: a, b, c, ab, ac, bc, or abc, where a, b, c can be single or multiple.

[0144] It should be understood that in various embodiments of the present invention, the size of the serial numbers of the above-mentioned processes does not mean the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of the present invention.

[0145] Those skilled in the art will appreciate that the units and algorithm steps of each example described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether these functions are performed in hardware or software depends on the specific application and design constraints of the technical solution. Professional and technical personnel can use different methods to implement the described functions for each specific application, but such implementation should not be considered to be beyond 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 above-described equipment, devices and units can refer to the corresponding processes in the aforementioned method embodiments and will not be repeated here.

[0147] In the 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 only schematic. For example, the division of the units is only a logical function division. There may be other division methods in actual implementation, such as 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 mutual coupling or direct coupling or communication connection shown or discussed can be through some interfaces, indirect coupling or communication connection of devices or units, which can be electrical, mechanical or other forms.

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

[0149] In addition, each functional unit in each embodiment of the present invention may be integrated into one processing unit, or each unit may exist physically separately, or two or more units may be integrated into one unit.

[0150] If the functions are implemented in the form of software functional units and sold or used as independent products, they can be stored in a computer-readable storage medium. Based on this understanding, the technical solution of the present invention can be essentially or partly embodied in the form of a software product that contributes to the prior art. The computer software product is stored in a storage medium and includes several instructions for enabling a computer device (which can be a personal computer, a server, or a network device, etc.) to perform 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 a USB flash drive, a mobile hard disk, a read-only memory (ROM), a random access memory (RAM), a magnetic disk or an optical disk.

[0151] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any person skilled in the art can easily think of changes or substitutions within the technical scope disclosed by the present invention, which should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on 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 detection of drug samples, the weight of the drug samples is measured, and solvent is added to dissolve according to a preset ratio. Combined with dilution and mixing, the color, viscosity, and pH value of the solution are recorded to generate a standardized sample solvent; Based on the standardized sample solvent, real-time detection and recording of particle size and quantity change information during drug dissolution process, evaluation of particle behavior pattern in solution, and obtaining dissolution rate measurement results; Using the dissolution rate measurement results, impedance measurement of the drug solution is performed, by monitoring the current response at multiple frequencies, analyzing the impedance changes of the drug components, evaluating the electrochemical stability and reactivity of the solution, identifying impurities in the solution, and generating solution impedance measurement results; According to the solution impedance measurement results, by measuring the spectral absorption and fluorescence characteristics of the drug solution, combining the drug dissolution rate and solution impedance, analyzing the chemical characteristics of the drug, identifying the active ingredients in the drug, and obtaining a sample component identification list; The sample component identification list is used to compare with the drug formula to analyze the consistency of drug component type and dosage, mark and extract multiple information of unqualified drugs, and generate drug component detection results.

2. The drug component detection method based on basic pharmacy according to claim 1, characterized in that: The standardized sample solvent generation result includes sample quality information, solvent color information, and solvent viscosity data; the dissolution rate measurement result includes particle size change, time series change data of particle number, and sample dissolution rate constant; the solution impedance measurement result includes impedance values ​​at multiple frequencies, electrochemical stability ratings, and current response characteristics of drug ingredients; the sample component identification list includes the chemical structure, concentration ratio, impurity type and content information of the active ingredient of the drug; the drug component detection result includes 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 detection of drug samples, the weight of the drug samples is measured, and the solvent is added to dissolve according to the preset ratio. Combined with dilution and mixing, the color, viscosity, and pH value of the solution are recorded. The specific steps for generating a standardized sample solvent are as follows: Based on the testing of drug samples, the drug quality is measured using an electronic scale, the sample weight is recorded, and drug weight data is generated; Based on the drug weight data and preset ratio information, the required amount of solvent is calculated, and the drug is dissolved to generate a sample dissolution result; Based on the sample dissolution results, the sample is diluted and mixed, and the color, viscosity and pH value of the drug sample solution are recorded to generate a standardized sample solution.

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 detection and recording of particle size and quantity change information during drug dissolution, evaluating the behavior pattern of particles in the solution, and obtaining the dissolution rate measurement result are as follows: Based on the standardized sample solution, real-time monitoring and recording of the change process of drug particles during drug dissolution process, and generating particle change monitoring data; Based on the particle change monitoring data, analyzing the particle size and quantity at multiple time points to generate particle behavior analysis data; Based on the particle behavior analysis data, the dissolution rate of the particles in the solution is calculated, the behavior pattern of the target sample particle dissolution is analyzed and recorded, and the dissolution rate measurement results are 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 particles in the solution is: Among them, R d represents the dissolution rate, ρ represents the density of drug particles, d represents the differential sign, and dt represents the infinitesimal increment of time. It represents the derivative with respect to time and is used to calculate the rate of change of particle volume over time. π is the circumference of a circle and r represents the radius of the particle.

6. The drug component detection method based on basic pharmacy according to claim 1, characterized in that: The dissolution rate measurement results are used to measure the impedance of the drug solution. By monitoring the current response at multiple frequencies, the impedance changes of the drug components are analyzed, the electrochemical stability and reactivity of the solution are evaluated, and the impurities in the solution are identified. The specific steps for generating the solution impedance measurement results are as follows: Based on the dissolution rate measurement results, using an impedance measurement device to monitor and record the current response data of the solution in real time to obtain current response data; Analyzing the current response data, analyzing the current response change of the solution by adjusting the potential parameters, identifying the resistance and capacitance characteristics of the solution, and obtaining impedance change data; Based on the impedance change data, the electrochemical stability and reactivity of the solution are evaluated, and the impurities in the solution are identified by combining the resistance and capacitance characteristics of various compounds to obtain the solution impedance measurement result.

7. The drug component detection method based on basic pharmacy according to claim 1, characterized in that: According to the solution impedance measurement results, by measuring the spectral absorption and fluorescence characteristics of the drug solution, combining the drug dissolution rate and solution impedance, analyzing the chemical characteristics of the drug, identifying the active ingredients in the drug, and obtaining the sample component identification list are specifically as follows: Based on the solution impedance measurement result, measuring the spectral absorption characteristics of the drug solution, recording the spectral data, and obtaining the spectral absorption data; Using the spectral absorption data, the fluorescence characteristics of the drug solution are measured to obtain fluorescence characteristic data; Based on the fluorescence characteristic data, combined with the dissolution rate of the drug, the impedance of the solution and the spectral characteristics, the active ingredients in the drug are identified to obtain a sample component identification list.

8. The drug component detection method based on basic pharmacy according to claim 1, characterized in that: The steps of using the 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 sample component identification list, combined with the formula information of the sample drug, by comparing the active ingredient and impurity list, the deviation component is 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.

9. The drug component detection method based on basic pharmacy according to claim 8, characterized in that: The specific formula for analyzing and calculating the dosage deviation of multiple drug components is: Among them, x i represents the measured content of the ingredient in the i-th drug sample, μ represents the theoretical content of the ingredient in the formula, and w i represents the weight based on the importance of the sample, K represents the weighted dose deviation value, and i represents the sequence number of the sample in the analysis batch.

10. A drug component detection system based on basic pharmacy, characterized in that: According to any one of claims 1 to 9, the drug component detection method based on basic pharmacy comprises: The sample preparation module measures the weight of the sample based on the drug sample to be tested, adds solvent in a preset ratio to dissolve it, and records the color, viscosity, and pH value of the solution through dilution and mixing to generate a standardized sample solution. The dissolution process monitoring module monitors the size and quantity of particles in the drug dissolution process in real time based on the standardized sample solution, evaluates the behavior pattern of the particles in the solution, and generates a dissolution rate measurement result; The electrochemical analysis module performs impedance measurement of the drug solution based on the dissolution rate measurement results, monitors the current response at multiple frequencies, analyzes the impedance changes of the drug components, evaluates the electrochemical stability and reactivity of the solution, identifies impurities in the solution, and generates solution impedance measurement results; The chemical property analysis module measures the spectral absorption and fluorescence properties of the drug solution based on the solution impedance measurement results, analyzes the chemical properties of the drug in combination with the drug dissolution rate and solution impedance, identifies the active ingredients in the drug, and generates a sample component identification list; The data comparison module analyzes the consistency of the drug sample component type and dosage based on the sample component identification list and generates component deviation analysis data by comparing with the drug formula; The drug screening module marks unqualified drugs based on the ingredient deviation analysis data, and extracts multiple key information of the target samples, including production batch, production date, and manufacturer, to generate drug ingredient detection results.

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