Component detection method and system for traditional Chinese medicine extract
Through the combined use of multi-dimensional chromatography and multi-detector technology, combined with data processing and analysis modules, the existing problems of complex, time-consuming, high cost and single information detection methods for the component detection of traditional Chinese medicine extracts are solved, and the rapid, accurate and efficient detection of the components of traditional Chinese medicine extracts is achieved.
Patent Information
- Application Number
- CN202510179963.0
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-02-18
- Publication Date
- 2025-05-13
AI Technical Summary
The existing Chinese medicine extract component detection methods have problems such as complex operation, long time, high cost and single information, and it is difficult to meet the needs of fast, accurate and efficient testing.
Multi-dimensional chromatography separation technology and multi-detector combination technology are used, combined with data processing and analysis modules, to realize multi-dimensional detection and analysis of Chinese medicine extract samples. The system includes a sample preparation module, a multi-dimensional chromatography separation module, a multi-detector combination module, a data processing and analysis module and a result output module.
Through the combination of multi-dimensional chromatography separation and multi-detectors, the separation and detection accuracy of the components of traditional Chinese medicine extracts is improved, the analysis time is shortened, the cost is reduced, and more comprehensive ingredient information is provided.
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Figure CN119985813A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of traditional Chinese medicine detection, and in particular to a method and system for detecting components of traditional Chinese medicine extracts. Background Art
[0002] As an important part of traditional Chinese medicine, the efficacy of Chinese medicine depends on the synergistic effect of multiple active ingredients. However, the composition of Chinese medicine extracts is complex and diverse, usually containing hundreds or even thousands of compounds. The types, contents and proportions of these ingredients directly affect the quality and efficacy of Chinese medicine. Therefore, accurate and rapid analysis and detection of the components of Chinese medicine extracts is a key link in Chinese medicine quality control, new drug research and development, and production process monitoring.
[0003] At present, the detection of Chinese medicine components mainly relies on the following technologies: high performance liquid chromatography, gas chromatography, mass spectrometry and ultraviolet-visible spectrophotometry. Although these methods have been widely used in the analysis of Chinese medicine components, they have the following limitations: complex operation: sample pretreatment and analysis process are cumbersome and require professional technicians to operate; time-consuming: the analysis cycle is long and it is difficult to meet the needs of rapid detection; high cost: the instruments and equipment are expensive and the maintenance cost is high; single information: a single detector is difficult to provide comprehensive component information and is prone to misjudgment. Therefore, technicians in this field provide a component detection method and system for Chinese medicine extracts to solve the problems raised in the above background technology. Summary of the invention
[0004] 1. Technical issues to be solved
[0005] In view of the deficiencies in the prior art, the present invention provides a method and system for detecting the components of a Chinese herbal medicine extract, which solves the problems of complex operation, long time consumption, high cost and single information in the prior analysis methods.
[0006] (II) Technical solution
[0007] To achieve the above objectives, the present invention is implemented through the following technical solutions: a component detection system for Chinese herbal medicine extracts, comprising:
[0008] The sample preparation module is used for sample dissolution and dilution pretreatment, and processes the Chinese herbal medicine extract sample into a solution state suitable for chromatographic analysis;
[0009] Multidimensional chromatography separation module, including first-dimension chromatography column, second-dimension chromatography column, pump and injector, can effectively separate different components in complex Chinese herbal medicine extract samples for subsequent detection and analysis;
[0010] Multi-detector combination module, including PDA, MS, ELSD and FLD detectors, uses the characteristics of different detectors to perform multi-dimensional detection and analysis of separated components to improve detection accuracy and reliability;
[0011] Data processing and analysis module, including data acquisition system, data processing software and database management system;
[0012] The result output module outputs the test results, including test reports, chromatograms, spectra and mass spectra.
[0013] Preferably, the sample preparation module comprises the following steps:
[0014] S1. Weigh the sample. Use a high-precision balance to accurately weigh a certain amount of Chinese herbal medicine extract sample. The sample amount should be determined according to the content of the target component and the sensitivity of the detector, usually between 1g and 10g;
[0015] S2. Select the solvent. Choose a suitable solvent based on the properties of the sample and the solubility of the target component. Commonly used solvents include methanol, ethanol, acetonitrile and water. When selecting the solvent, the solubility of the target component, the polarity of the solvent and the effect of the solvent on the chromatographic column and detector should also be considered;
[0016] S3. Dissolve the sample, add the weighed sample into an appropriate amount of solvent, the volume of the solvent is determined according to the sample amount and the target concentration, and use an ultrasonic cleaner to ultrasonically treat the sample solution to ensure that the sample is completely dissolved, wherein the ultrasonic power is 100W to 500W; the ultrasonic time is 20 to 40 minutes; the ultrasonic temperature is 20°C to 25°C, and can be heated to 40°C as needed;
[0017] S4. Filter the sample, use a 0.22 μm microporous filter membrane to filter the sample solution, remove insoluble matter and impurities, and obtain a clear sample solution to be tested. The filtration process can use a disposable syringe filter or a vacuum filtration device;
[0018] S5. Dilute the sample. If the concentration in the filtered sample solution is too high, it can be appropriately diluted. The dilution process should use the same solvent as the sample solution and ensure that the dilution multiple is accurate. If the sample solution cannot be analyzed immediately, it can be stored in an appropriate container and kept in an environment not higher than 4°C.
[0019] Preferably, the multidimensional chromatography separation module comprises the following steps:
[0020] S1. First-dimension chromatographic separation, chromatographic column selection: select conventional C18 column and C8 column reverse phase chromatographic column, and the specifications of the chromatographic column should be selected according to the sample amount and separation requirements; mobile phase selection: use binary solvent system for gradient elution, and commonly used mobile phase combinations include methanol-water and acetonitrile-water; the composition and gradient of the mobile phase should be adjusted according to the properties of the target component, and the gradient elution time is 30 minutes; flow rate setting: the flow rate is set to 1.0mL / min to ensure the separation effect and analysis time; injection volume: according to the capacity of the chromatographic column and the sensitivity of the detector, the injection volume is set to 20μL; operating parameters: the column temperature is set to 20℃ to 25℃, and the detection wavelength range of the PDA detector is set according to the UV-visible absorption characteristics of the target component;
[0021] S2. Second-dimension chromatography, chromatographic column selection: select chromatographic columns with different selectivities, including but not limited to hydrophilic interaction chromatography columns and ion exchange chromatography columns, to achieve the separation of components of different polarities. The specifications of the chromatographic columns should be selected according to the separation requirements and the effluent volume of the first-dimension chromatography separation; mobile phase selection: select a suitable mobile phase according to the type of chromatographic column. Commonly used mobile phase combinations include acetonitrile-water and phosphate buffer-water; the composition and gradient of the mobile phase should be adjusted according to the properties of the target components, and the gradient elution time is 15 minutes; flow rate setting: set the flow rate to 0.5mL / min to ensure the separation effect and analysis time; switching time: determine the switching time between the first-dimension chromatography separation and the second-dimension chromatography separation to ensure that different components can be effectively transferred to the second-dimension chromatography column for further separation. The switching time is adjusted according to the effluent volume of the first-dimension chromatography separation and the capacity of the second-dimension chromatography column, and is set to switch every 5 minutes; the column temperature is the same as the first-dimension chromatography separation.
[0022] Preferably, the multi-detector combination module comprises the following steps:
[0023] S1. Detector selection and configuration, select a suitable detector and configure it. Common detectors include but are not limited to photodiode array detector, mass spectrometer detector, evaporative light scattering detector and fluorescence detector. The detection wavelength range of the photodiode array detector is 200 to 400nm, and the data acquisition rate is 10Hz-20Hz; the scanning range of the mass spectrometer detector is set at 100-1500m / z, the ion source temperature is 300℃ to 350℃, and the capillary voltage is set to 3kv to 4kv; the configuration parameters of the evaporative light scattering detector, drift tube temperature: set to 50℃ to 60℃, nitrogen flow rate is set to 1.5-2L / min, and evaporation temperature is set to 40℃ to 50℃; the excitation wavelength of the fluorescence detector is set to 280nm, the emission wavelength is set to 340nm, and the photomultiplier tube voltage is set to 500-700v;
[0024] S2. Detector combination mode: multiple detectors are connected in series, and the sample components are detected by each detector in turn, so that multi-dimensional data of each component can be obtained with comprehensive information;
[0025] S3. Data acquisition and synchronization: data from each detector is collected synchronously and analyzed in real time. The data acquisition system has a high sampling rate and a wide dynamic range to ensure the accuracy and reliability of the data. The data acquisition of each detector is synchronized with the chromatographic separation process to ensure that the data of each chromatographic peak can be accurately matched;
[0026] S4. Data processing and analysis: collect data from each detector, and use multivariate data analysis methods to process and analyze the data, compare the test data with the Chinese medicine extract component database, identify and quantitatively analyze each component, and combine UV-visible spectra, mass spectra and fluorescence spectra for comprehensive analysis to improve the accuracy of component identification;
[0027] S5. Output the results and generate a test report, including the type, content and purity of each component. The report should contain the original data of the chromatogram, spectrum and mass spectrum, as well as the analysis results and conclusions. The test data and analysis results are stored in the database for subsequent query and analysis.
[0028] Preferably, the data processing and analysis module comprises the following steps:
[0029] S1. Data import and preprocessing: import the data collected by the multi-detector combination module into the data processing software. Data preprocessing: perform baseline correction on the chromatogram and spectrum to eliminate the influence of baseline drift and background noise; perform time alignment on the data collected by different detectors to ensure that the data of each chromatographic peak can accurately correspond; use the peak recognition algorithm to automatically identify each peak in the chromatogram and determine its retention time and peak area; perform purity check on each peak to ensure that it represents a single component;
[0030] S2. Multivariate data analysis, using principal component analysis method, input the preprocessed data matrix into the PCA algorithm, calculate the covariance matrix or correlation coefficient matrix, calculate the eigenvalues and eigenvectors, and project the data into the principal component space for visual analysis;
[0031] S3. Component identification and quantitative analysis. First, the test data is compared with the Chinese medicine extract component database to identify the components corresponding to each chromatographic peak. The database contains the information of the retention time, UV-visible spectrum and mass spectrum of the known components. The multivariate analysis results can be combined to conduct a comprehensive analysis to improve the accuracy of component identification. Secondly, the standard curve method is used to quantitatively analyze each component, establish a standard curve, compare the peak area of the target component in the sample with the standard curve, and calculate the component content.
[0032] S4. Result verification and interpretation: verify the analysis results, analyze the same batch of samples multiple times, evaluate the significance of the results, analyze different batches of samples, evaluate the reproducibility of the results, use standard substances for verification, evaluate the accuracy of the analysis method, combine the multivariate analysis results and component identification results, interpret the composition and content of the Chinese medicine extracts, and draw component distribution diagrams and content comparison diagrams to help understand and interpret the results;
[0033] S5. Report generation, the report content includes sample information, analysis conditions and analysis results.
[0034] A method for detecting components of a Chinese medicine extract comprises the following steps:
[0035] S1. Sample preparation: dissolving the Chinese herbal medicine extract sample in an appropriate solvent to prepare a sample solution to be tested;
[0036] S2. Multidimensional chromatography separation, using multidimensional chromatography technology to separate the sample;
[0037] S3. Multiple detectors are used in combination to detect the separated components in sequence through multiple detectors, including but not limited to photodiode array detector: used to detect UV-visible spectra; mass spectrometer detector: used to detect molecular weight and structural information; evaporative light scattering detector: used to detect non-volatile compounds; fluorescence detector: used to detect compounds with fluorescent properties;
[0038] S4. Data processing and analysis: collect data from each detector and use multivariate data analysis methods to process and analyze the data. At the same time, establish a database of components of Chinese herbal medicine extracts, compare the test data with the database, and identify and quantitatively analyze each component;
[0039] S5. Output the results and generate a test report, including information on the type, content and purity of each component.
[0040] (III) Beneficial effects
[0041] The present invention provides a method and system for detecting components of Chinese herbal medicine extracts. The method has the following beneficial effects:
[0042] 1. In the present invention, by using multidimensional chromatographic separation technology and utilizing the selectivity differences of different chromatographic columns, the separation degree of complex Chinese medicine extract samples can be effectively improved. At the same time, by optimizing the mobile phase composition and gradient elution procedure, the analysis time can be shortened and the analysis efficiency can be improved. Multidimensional chromatographic separation can reduce sample loss and improve the sensitivity and accuracy of detection.
[0043] 2. In the present invention, different types of analytical data can be obtained through the multi-detector combination technology, including UV-visible spectra, mass spectrometry information and fluorescence characteristics. Combining the data from different detectors can improve the accuracy of component identification and reduce the possibility of misjudgment. The combination of multiple detectors can realize the detection and analysis of multiple characteristics of the same component, thereby providing more comprehensive analysis results.
[0044] 3. In the present invention, multivariate data analysis methods are used to perform dimensionality reduction, pattern recognition and quantitative analysis on complex data. Through multivariate data analysis, complex data can be analyzed more comprehensively and the accuracy of component identification can be improved. Multivariate data analysis can be performed automatically to reduce human errors and improve analysis efficiency. BRIEF DESCRIPTION OF THE DRAWINGS
[0045] Figure 1 It is a schematic diagram of the structure of the present invention. DETAILED DESCRIPTION
[0046] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.
[0047] Embodiment 1:
[0048] like Figure 1 As shown, an embodiment of the present invention provides a component detection system for a traditional Chinese medicine extract, comprising:
[0049] The sample preparation module is used for sample dissolution and dilution pretreatment, and processes the Chinese herbal medicine extract sample into a solution state suitable for chromatographic analysis;
[0050] Multidimensional chromatography separation module, including first-dimension chromatography column, second-dimension chromatography column, pump and injector, can effectively separate different components in complex Chinese herbal medicine extract samples for subsequent detection and analysis;
[0051] Multi-detector combination module, including PDA, MS, ELSD and FLD detectors, uses the characteristics of different detectors to perform multi-dimensional detection and analysis of separated components to improve detection accuracy and reliability;
[0052] Data processing and analysis module, including data acquisition system, data processing software and database management system;
[0053] The result output module outputs the test results, including test reports, chromatograms, spectra and mass spectra.
[0054] The sample preparation module includes the following steps:
[0055] S1. Weigh the sample. Use a high-precision balance to accurately weigh a certain amount of Chinese herbal medicine extract sample. The sample amount should be determined according to the content of the target component and the sensitivity of the detector, usually between 1g and 10g;
[0056] S2. Select the solvent. Choose a suitable solvent based on the properties of the sample and the solubility of the target component. Commonly used solvents include methanol, ethanol, acetonitrile and water. When selecting the solvent, the solubility of the target component, the polarity of the solvent and the effect of the solvent on the chromatographic column and detector should also be considered;
[0057] S3. Dissolve the sample, add the weighed sample into an appropriate amount of solvent, the volume of the solvent is determined according to the sample amount and the target concentration, and use an ultrasonic cleaner to ultrasonically treat the sample solution to ensure that the sample is completely dissolved, wherein the ultrasonic power is 100W to 500W; the ultrasonic time is 20 to 40 minutes; the ultrasonic temperature is 20°C to 25°C, and can be heated to 40°C as needed;
[0058] S4. Filter the sample, use a 0.22 μm microporous filter membrane to filter the sample solution, remove insoluble matter and impurities, and obtain a clear sample solution to be tested. The filtration process can use a disposable syringe filter or a vacuum filtration device;
[0059] S5. Dilute the sample. If the concentration in the filtered sample solution is too high, it can be appropriately diluted. The dilution process should use the same solvent as the sample solution and ensure that the dilution multiple is accurate. If the sample solution cannot be analyzed immediately, it can be stored in an appropriate container and kept in an environment not higher than 4°C.
[0060] The multidimensional chromatography separation module includes the following steps:
[0061] S1. First-dimension chromatographic separation, chromatographic column selection: select conventional C18 column and C8 column reverse phase chromatographic column, and the specifications of the chromatographic column should be selected according to the sample amount and separation requirements; mobile phase selection: use binary solvent system for gradient elution, and commonly used mobile phase combinations include methanol-water and acetonitrile-water; the composition and gradient of the mobile phase should be adjusted according to the properties of the target component, and the gradient elution time is 30 minutes; flow rate setting: the flow rate is set to 1.0mL / min to ensure the separation effect and analysis time; injection volume: according to the capacity of the chromatographic column and the sensitivity of the detector, the injection volume is set to 20μL; operating parameters: the column temperature is set to 20℃ to 25℃, and the detection wavelength range of the PDA detector is set according to the UV-visible absorption characteristics of the target component;
[0062] S2. Second-dimension chromatography, chromatographic column selection: select chromatographic columns with different selectivities, including but not limited to hydrophilic interaction chromatography columns and ion exchange chromatography columns, to achieve the separation of components of different polarities. The specifications of the chromatographic columns should be selected according to the separation requirements and the effluent volume of the first-dimension chromatography separation; mobile phase selection: select a suitable mobile phase according to the type of chromatographic column. Commonly used mobile phase combinations include acetonitrile-water and phosphate buffer-water; the composition and gradient of the mobile phase should be adjusted according to the properties of the target components, and the gradient elution time is 15 minutes; flow rate setting: set the flow rate to 0.5mL / min to ensure the separation effect and analysis time; switching time: determine the switching time between the first-dimension chromatography separation and the second-dimension chromatography separation to ensure that different components can be effectively transferred to the second-dimension chromatography column for further separation. The switching time is adjusted according to the effluent volume of the first-dimension chromatography separation and the capacity of the second-dimension chromatography column, and is set to switch every 5 minutes; the column temperature is the same as the first-dimension chromatography separation.
[0063] The multi-detector module includes the following steps:
[0064] S1. Detector selection and configuration, select a suitable detector and configure it. Common detectors include but are not limited to photodiode array detector, mass spectrometer detector, evaporative light scattering detector and fluorescence detector. The detection wavelength range of the photodiode array detector is 200 to 400nm, and the data acquisition rate is 10Hz-20Hz; the scanning range of the mass spectrometer detector is set at 100-1500m / z, the ion source temperature is 300℃ to 350℃, and the capillary voltage is set to 3kv to 4kv; the configuration parameters of the evaporative light scattering detector, drift tube temperature: set to 50℃ to 60℃, nitrogen flow rate is set to 1.5-2L / min, and evaporation temperature is set to 40℃ to 50℃; the excitation wavelength of the fluorescence detector is set to 280nm, the emission wavelength is set to 340nm, and the photomultiplier tube voltage is set to 500-700v;
[0065] S2. Detector combination mode: multiple detectors are connected in series, and the sample components are detected by each detector in turn, so that multi-dimensional data of each component can be obtained with comprehensive information;
[0066] S3. Data acquisition and synchronization: data from each detector is collected synchronously and analyzed in real time. The data acquisition system has a high sampling rate and a wide dynamic range to ensure the accuracy and reliability of the data. The data acquisition of each detector is synchronized with the chromatographic separation process to ensure that the data of each chromatographic peak can be accurately matched;
[0067] S4. Data processing and analysis: collect data from each detector, and use multivariate data analysis methods to process and analyze the data, compare the test data with the Chinese medicine extract component database, identify and quantitatively analyze each component, and combine UV-visible spectra, mass spectra and fluorescence spectra for comprehensive analysis to improve the accuracy of component identification;
[0068] S5. Output the results and generate a test report, including the type, content and purity of each component. The report should contain the original data of the chromatogram, spectrum and mass spectrum, as well as the analysis results and conclusions. The test data and analysis results are stored in the database for subsequent query and analysis.
[0069] The data processing and analysis module includes the following steps:
[0070] S1. Data import and preprocessing: import the data collected by the multi-detector combination module into the data processing software. Data preprocessing: perform baseline correction on the chromatogram and spectrum to eliminate the influence of baseline drift and background noise; perform time alignment on the data collected by different detectors to ensure that the data of each chromatographic peak can accurately correspond; use the peak recognition algorithm to automatically identify each peak in the chromatogram and determine its retention time and peak area; perform purity check on each peak to ensure that it represents a single component;
[0071] S2. Multivariate data analysis, using principal component analysis method, input the preprocessed data matrix into the PCA algorithm, calculate the covariance matrix or correlation coefficient matrix, calculate the eigenvalues and eigenvectors, and project the data into the principal component space for visual analysis;
[0072] S3. Component identification and quantitative analysis. First, the test data is compared with the Chinese medicine extract component database to identify the components corresponding to each chromatographic peak. The database contains the information of the retention time, UV-visible spectrum and mass spectrum of the known components. The multivariate analysis results can be combined to conduct a comprehensive analysis to improve the accuracy of component identification. Secondly, the standard curve method is used to quantitatively analyze each component, establish a standard curve, compare the peak area of the target component in the sample with the standard curve, and calculate the component content.
[0073] S4. Result verification and interpretation: verify the analysis results, analyze the same batch of samples multiple times, evaluate the significance of the results, analyze different batches of samples, evaluate the reproducibility of the results, use standard substances for verification, evaluate the accuracy of the analysis method, combine the multivariate analysis results and component identification results, interpret the composition and content of the Chinese medicine extracts, and draw component distribution diagrams and content comparison diagrams to help understand and interpret the results;
[0074] S5. Report generation, the report content includes sample information, analysis conditions and analysis results.
[0075] A method for detecting components of a Chinese medicine extract comprises the following steps:
[0076] S1. Sample preparation: dissolving the Chinese herbal medicine extract sample in an appropriate solvent to prepare a sample solution to be tested;
[0077] S2. Multidimensional chromatography separation, using multidimensional chromatography technology to separate the sample;
[0078] S3. Multiple detectors are used in combination to detect the separated components in sequence through multiple detectors, including but not limited to photodiode array detector: used to detect UV-visible spectra; mass spectrometer detector: used to detect molecular weight and structural information; evaporative light scattering detector: used to detect non-volatile compounds; fluorescence detector: used to detect compounds with fluorescent properties;
[0079] S4. Data processing and analysis: collect data from each detector and use multivariate data analysis methods to process and analyze the data. At the same time, establish a database of components of Chinese herbal medicine extracts, compare the test data with the database, and identify and quantitatively analyze each component;
[0080] S5. Output the results and generate a test report, including information on the type, content and purity of each component.
[0081] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.
Claims
1. A component detection system for a Chinese medicine extract, characterized in that: include: The sample preparation module is used for sample dissolution and dilution pretreatment, and processes the Chinese herbal medicine extract sample into a solution state suitable for chromatographic analysis; Multidimensional chromatography separation module, including first-dimension chromatography column, second-dimension chromatography column, pump and injector, can effectively separate different components in complex Chinese herbal medicine extract samples for subsequent detection and analysis; Multi-detector combination module, including PDA, MS, ELSD and FLD detectors, uses the characteristics of different detectors to perform multi-dimensional detection and analysis of separated components to improve detection accuracy and reliability; Data processing and analysis module, including data acquisition system, data processing software and database management system; The result output module outputs the test results, including test reports, chromatograms, spectra and mass spectra.
2. The component detection system of a Chinese medicine extract according to claim 1, characterized in that: The sample preparation module comprises the following steps: S1. Weigh the sample. Use a high-precision balance to accurately weigh a certain amount of Chinese herbal medicine extract sample. The sample amount should be determined according to the content of the target component and the sensitivity of the detector, usually between 1g and 10g; S2. Select the solvent. Choose a suitable solvent based on the properties of the sample and the solubility of the target component. Commonly used solvents include methanol, ethanol, acetonitrile and water. When selecting the solvent, the solubility of the target component, the polarity of the solvent and the effect of the solvent on the chromatographic column and detector should also be considered; S3. Dissolve the sample, add the weighed sample into an appropriate amount of solvent, the volume of the solvent is determined according to the sample amount and the target concentration, and use an ultrasonic cleaner to ultrasonically treat the sample solution to ensure that the sample is completely dissolved, wherein the ultrasonic power is 100W to 500W; the ultrasonic time is 20 to 40 minutes; the ultrasonic temperature is 20°C to 25°C, and can be heated to 40°C as needed; S4. Filter the sample, use a 0.22 μm microporous filter membrane to filter the sample solution, remove insoluble matter and impurities, and obtain a clear sample solution to be tested. The filtration process can use a disposable syringe filter or a vacuum filtration device; S5. Dilute the sample. If the concentration in the filtered sample solution is too high, it can be appropriately diluted. The dilution process should use the same solvent as the sample solution and ensure that the dilution multiple is accurate. If the sample solution cannot be analyzed immediately, it can be stored in an appropriate container and kept in an environment not higher than 4°C.
3. The component detection system of a Chinese medicine extract according to claim 1, characterized in that: The multidimensional chromatography separation module comprises the following steps: S1. First-dimension chromatographic separation, chromatographic column selection: select conventional C18 column and C8 column reverse phase chromatographic column, and the specifications of the chromatographic column should be selected according to the sample amount and separation requirements; mobile phase selection: use binary solvent system for gradient elution, and commonly used mobile phase combinations include methanol-water and acetonitrile-water; the composition and gradient of the mobile phase should be adjusted according to the properties of the target component, and the gradient elution time is 30 minutes; flow rate setting: the flow rate is set to 1.0mL / min to ensure the separation effect and analysis time; injection volume: according to the capacity of the chromatographic column and the sensitivity of the detector, the injection volume is set to 20μL; operating parameters: the column temperature is set to 20℃ to 25℃, and the detection wavelength range of the PDA detector is set according to the UV-visible absorption characteristics of the target component; S2. Second-dimension chromatography, chromatographic column selection: select chromatographic columns with different selectivities, including but not limited to hydrophilic interaction chromatography columns and ion exchange chromatography columns, to achieve the separation of components of different polarities. The specifications of the chromatographic columns should be selected according to the separation requirements and the effluent volume of the first-dimension chromatography separation; mobile phase selection: select a suitable mobile phase according to the type of chromatographic column. Commonly used mobile phase combinations include acetonitrile-water and phosphate buffer-water; the composition and gradient of the mobile phase should be adjusted according to the properties of the target components, and the gradient elution time is 15 minutes; flow rate setting: set the flow rate to 0.5mL / min to ensure the separation effect and analysis time; switching time: determine the switching time between the first-dimension chromatography separation and the second-dimension chromatography separation to ensure that different components can be effectively transferred to the second-dimension chromatography column for further separation. The switching time is adjusted according to the effluent volume of the first-dimension chromatography separation and the capacity of the second-dimension chromatography column, and is set to switch every 5 minutes; the column temperature is the same as the first-dimension chromatography separation.
4. The component detection system of a Chinese medicine extract according to claim 1, characterized in that: The multi-detector combination module comprises the following steps: S1. Detector selection and configuration, select a suitable detector and configure it. Common detectors include but are not limited to photodiode array detector, mass spectrometer detector, evaporative light scattering detector and fluorescence detector. The detection wavelength range of the photodiode array detector is 200 to 400nm, and the data acquisition rate is 10Hz-20Hz; the scanning range of the mass spectrometer detector is set at 100-1500m / z, the ion source temperature is 300℃ to 350℃, and the capillary voltage is set to 3kv to 4kv; the configuration parameters of the evaporative light scattering detector, drift tube temperature: set to 50℃ to 60℃, nitrogen flow rate is set to 1.5-2L / min, and evaporation temperature is set to 40℃ to 50℃; the excitation wavelength of the fluorescence detector is set to 280nm, the emission wavelength is set to 340nm, and the photomultiplier tube voltage is set to 500-700v; S2. Detector combination mode: multiple detectors are connected in series, and the sample components are detected by each detector in turn, so that multi-dimensional data of each component can be obtained with comprehensive information; S3. Data acquisition and synchronization: data from each detector is collected synchronously and analyzed in real time. The data acquisition system has a high sampling rate and a wide dynamic range to ensure the accuracy and reliability of the data. The data acquisition of each detector is synchronized with the chromatographic separation process to ensure that the data of each chromatographic peak can be accurately matched; S4. Data processing and analysis: collect data from each detector, and use multivariate data analysis methods to process and analyze the data, compare the test data with the Chinese medicine extract component database, identify and quantitatively analyze each component, and combine UV-visible spectra, mass spectra and fluorescence spectra for comprehensive analysis to improve the accuracy of component identification; S5. Output the results and generate a test report, including the type, content and purity of each component. The report should contain the original data of the chromatogram, spectrum and mass spectrum, as well as the analysis results and conclusions. The test data and analysis results are stored in the database for subsequent query and analysis.
5. The component detection system of a Chinese medicine extract according to claim 1, characterized in that: The data processing and analysis module includes the following steps: S1. Data import and preprocessing: import the data collected by the multi-detector combination module into the data processing software. Data preprocessing: perform baseline correction on the chromatogram and spectrum to eliminate the influence of baseline drift and background noise; perform time alignment on the data collected by different detectors to ensure that the data of each chromatographic peak can accurately correspond; use the peak recognition algorithm to automatically identify each peak in the chromatogram and determine its retention time and peak area; perform purity check on each peak to ensure that it represents a single component; S2. Multivariate data analysis, using principal component analysis method, input the preprocessed data matrix into the PCA algorithm, calculate the covariance matrix or correlation coefficient matrix, calculate the eigenvalues and eigenvectors, and project the data into the principal component space for visual analysis; S3. Component identification and quantitative analysis. First, the test data is compared with the Chinese medicine extract component database to identify the components corresponding to each chromatographic peak. The database contains the information of the retention time, UV-visible spectrum and mass spectrum of the known components. The multivariate analysis results can be combined to conduct a comprehensive analysis to improve the accuracy of component identification. Secondly, the standard curve method is used to quantitatively analyze each component, establish a standard curve, compare the peak area of the target component in the sample with the standard curve, and calculate the component content. S4. Result verification and interpretation: verify the analysis results, analyze the same batch of samples multiple times, evaluate the significance of the results, analyze different batches of samples, evaluate the reproducibility of the results, use standard substances for verification, evaluate the accuracy of the analysis method, combine the multivariate analysis results and component identification results, interpret the composition and content of the Chinese medicine extracts, and draw component distribution diagrams and content comparison diagrams to help understand and interpret the results; S5. Report generation, the report content includes sample information, analysis conditions and analysis results.
6. A method for detecting components of Chinese herbal medicine extracts, characterized in that: The following steps are involved: S1. Sample preparation: dissolving the Chinese herbal medicine extract sample in an appropriate solvent to prepare a sample solution to be tested; S2. Multidimensional chromatography separation, using multidimensional chromatography technology to separate the sample; S3. Multiple detectors are used to detect the separated components in sequence through multiple detectors, including but not limited to photodiode array detectors: for detecting UV-visible spectra; Mass spectrometer detector: used to detect molecular weight and structural information; Evaporative light scattering detector: used to detect non-volatile compounds; Fluorescence detector: used to detect compounds with fluorescent properties; S4. Data processing and analysis: collect data from each detector and use multivariate data analysis methods to process and analyze the data. At the same time, establish a database of components of Chinese herbal medicine extracts, compare the test data with the database, and identify and quantitatively analyze each component; S5. Output the results and generate a test report, including information on the type, content and purity of each component.
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