Traditional Chinese medicine clinical curative effect data acquisition device and analysis method based on multi-channel detection

Abstract

The invention provides a traditional Chinese medicine clinical curative effect data acquisition device and analysis method based on multi-channel detection, and relates to the field of medical instruments. The traditional Chinese medicine clinical curative effect data acquisition device based on multi-channel detection comprises a multi-channel synchronous acquisition module, a traditional Chinese medicine component extraction module, a data preprocessing module, a core analysis module, a terminal display module and a data storage module. According to the invention, the functions of multi-channel extraction and quantitative detection of effective components of traditional Chinese medicines are effectively integrated, standardized detection of process parameters and component contents in a pilot test stage is realized, the effects of detection precision and standardization similar to those of western medicine pilot tests are achieved, and a standardized traditional Chinese medicine clinical case data acquisition system is constructed; synchronous acquisition of case basic information, curative effect indexes and component metabolism data is realized, and the problem of data fragmentation is solved.

Description

Technical Field

[0001] This invention relates to the field of medical devices, specifically to a data acquisition and analysis method for clinical efficacy data of traditional Chinese medicine based on multi-channel detection. Background Technology

[0002] Traditional Chinese medicine (TCM) has complex components, and a single TCM herb or prepared TCM medicine often contains multiple effective active ingredients. Existing technologies mostly use single extraction methods, which have low extraction efficiency and high impurity content. Furthermore, there is a lack of technical means for simultaneous extraction and quantitative detection of multiple components, making it impossible to accurately determine the content and purity of a single effective ingredient. This results in a lack of scientific basis for optimizing process parameters in the pilot-scale stage, making it difficult to guarantee the consistency of components among different batches of TCM. Clinical data collection for TCM is mostly based on descriptions of symptom improvement, lacking quantitative indicators, and basic case information, efficacy indicators, and metabolic data of TCM components are collected in a scattered manner.

[0003] To address the aforementioned problems, this invention proposes a data acquisition device and analysis method for clinical efficacy of traditional Chinese medicine based on multi-channel detection, thereby effectively solving the aforementioned difficulties and challenges. Summary of the Invention

[0004] To address the shortcomings of existing technologies, this invention provides a data acquisition device and analysis method for clinical efficacy of traditional Chinese medicine (TCM) based on multi-channel detection. This effectively integrates the functions of multi-channel extraction and quantitative detection of effective components in TCM, enabling standardized detection of process parameters and component content during pilot-scale testing. It achieves similar detection accuracy and standardization as pilot-scale testing of Western medicine. Furthermore, it constructs a standardized TCM clinical case data acquisition system, enabling the simultaneous acquisition of basic case information, efficacy indicators, and component metabolism data, thus solving the problem of data fragmentation. Simultaneously, it designs a scientific multi-source data fusion analysis model to establish a quantitative correlation between TCM component content and clinical efficacy, achieving accurate evaluation of TCM efficacy and aligning with the clinical efficacy evaluation system of Western medicine.

[0005] To achieve the above objectives, the present invention provides the following technical solution: A data acquisition device for clinical efficacy of traditional Chinese medicine based on multi-channel detection includes a multi-channel synchronous acquisition module, a traditional Chinese medicine component extraction module, a data preprocessing module, a core analysis module, a terminal display module, and a data storage module. The multi-channel synchronous acquisition module includes four independent acquisition channels: a pilot-scale process parameter acquisition channel, a traditional Chinese medicine component detection channel, a clinical basic data acquisition channel, and a clinical efficacy indicator acquisition channel. The multi-channel synchronous acquisition module is used to simultaneously acquire process parameters, effective component content data, basic clinical case information, and clinical efficacy indicator data of traditional Chinese medicine in the pilot-scale stage. The traditional Chinese medicine component extraction module is linked with the traditional Chinese medicine component detection channel to achieve simultaneous extraction of effective components of traditional Chinese medicine using multiple methods. It can select a single or combined extraction method according to the type of traditional Chinese medicine and the type of effective components, including an ultrasound-assisted extraction unit, a microwave-assisted extraction unit, a supercritical fluid extraction unit, and a solvent extraction unit. The data preprocessing module is used to clean, standardize, and eliminate noise interference from the raw data acquired by the multi-channel synchronous acquisition module. The specific processing steps include data cleaning, dimensional standardization, and data alignment. The core analysis module incorporates a multi-source data fusion algorithm and a quantitative analysis model, including a component extraction efficiency analysis unit, a component content similarity analysis unit, a component efficacy correlation analysis unit, a clinical efficacy quantitative evaluation unit, and a pilot-scale process optimization unit. The terminal display module is used to display the collected data, preprocessing results and core analysis results in real time, and supports data query, export and printing. The data storage module adopts a dual storage method of local solid-state drive and cloud, which is used to encrypt and store raw data, preprocessed data, analysis results and device operation logs, and supports data backup, recovery and multi-terminal sharing.

[0006] Furthermore, the pilot-scale process parameter acquisition channel of the multi-channel synchronous acquisition module is equipped with a high-precision temperature sensor, pressure sensor, stirring speed sensor and solvent concentration sensor, which are used to acquire process parameters such as extraction temperature, extraction time, solvent concentration, stirring speed and extraction pressure in the pilot-scale extraction process of traditional Chinese medicine in real time. The acquired data is transmitted to the data preprocessing module in real time. The TCM component detection channel includes an ultrasound-assisted extraction unit, a microwave-assisted extraction unit, a supercritical fluid extraction unit, and a traditional solvent extraction unit. It also has a built-in extraction efficiency monitoring unit to monitor the dissolution of effective components in real time during the extraction process. When the dissolution reaches a stable value, the extraction is automatically stopped to avoid over-extraction that leads to an increase in impurities. At the same time, it records key parameters during the extraction process. The clinical basic data acquisition channel is used to collect basic information of clinical cases. Data is entered through a touch input unit or a wireless transmission unit, and the format is automatically checked after the data is entered. The clinical efficacy indicator collection channel is used to collect efficacy-related indicators of patients after medication, including physiological indicators, TCM syndrome indicators, and quality of life scale scores.

[0007] Furthermore, the ultrasonic-assisted extraction unit of the traditional Chinese medicine component extraction module uses a high-frequency ultrasonic generator to release the effective components in the traditional Chinese medicine through the vibration and cavitation of ultrasonic waves, and accelerates the contact and dissolution of the solvent with the effective components. The microwave-assisted extraction unit uses a microwave generator to use the energy of microwaves to heat and expand the effective components in the traditional Chinese medicine and release them. The supercritical fluid extraction unit uses CO2 as the supercritical fluid and utilizes the special properties of supercritical fluid to dissolve the effective components in the traditional Chinese medicine in the supercritical fluid. Then, by adjusting the pressure or temperature of the fluid, the effective components are selectively extracted. The solvent extraction unit uses traditional solvents for extraction, supports solvent concentration adjustment, and is equipped with a constant temperature stirring device.

[0008] Furthermore, the data purification function of the data preprocessing module uses the 3σ criterion to remove outlier data. Assuming that the data follows a normal distribution, it removes data that deviates from the mean by more than three times the standard deviation, i.e., it removes data that satisfies |x-μ|>3σ, where x is the original value of the j-th indicator of the i-th sample, μ is the mean of the j-th indicator, and σ is the standard deviation of the j-th indicator; missing data is supplemented using linear interpolation or mean imputation. The data preprocessing module standardizes the dimensions by normalizing the data to the [0,1] interval, eliminating the influence of dimensions. The normalization formula is as follows: ; in, Let j be the normalized value of the i-th indicator. Let j be the original value of the j-th indicator for the i-th sample. The maximum value of the j-th indicator. The minimum value of the j-th indicator; The data preprocessing module aligns synchronous data from different channels based on the acquisition timestamp, ensuring that process parameters, component content, case information, and efficacy indicators of the same sample at the same time point correspond one-to-one, forming a complete sample data matrix.

[0009] Furthermore, the component extraction efficiency analysis unit of the core analysis module calculates the extraction efficiency of the effective components of traditional Chinese medicine based on the extraction parameters and component detection data collected by the extraction module, and optimizes the pilot-scale extraction process parameters. The extraction efficiency calculation formula is as follows: ; in, Let be the extraction efficiency of the k-th active ingredient. This represents the actual extraction amount (mg) of the kth active ingredient after extraction. The total content of the kth active ingredient in the raw material; Simultaneously, the overall extraction efficiency is calculated, taking into account the extraction of multiple effective components. The calculation formula is as follows: ; in, To determine the overall extraction efficiency, n represents the number of types of active ingredients. The weighting coefficient for the k-th effective ingredient; The component content similarity analysis unit of the core analysis module calculates the component similarity of different batches of traditional Chinese medicine based on the fingerprint spectrum data collected by the component detection channel, and evaluates the consistency of the quality of traditional Chinese medicine. It uses a cosine similarity algorithm, and the calculation formula is as follows: ; Where S represents the similarity of the components of the i-th batch and the j-th batch of traditional Chinese medicine. The closer S is to 1, the better the consistency of the components between the two batches of traditional Chinese medicine. Let be the peak area of ​​the k-th characteristic peak of the i-th batch of traditional Chinese medicine. Let n be the peak area of ​​the kth characteristic peak of the jth batch of traditional Chinese medicine, and n be the number of characteristic peaks.

[0010] Furthermore, the component-therapeutic efficacy correlation analysis unit of the core analysis module establishes a correlation model between the content of effective components of traditional Chinese medicine and clinical efficacy indicators based on preprocessed multi-source data. Pearson correlation analysis is used to calculate the correlation coefficient between component content and efficacy indicators. The calculation formula is as follows: ; in Let r be the correlation coefficient between the content of the k-th effective ingredient and the l-th efficacy indicator. r>0 indicates a positive correlation, r<0 indicates a negative correlation, and the closer |r| is to 1, the stronger the correlation. m is the number of clinical case samples. The content of the k-th effective ingredient in the i-th case. The average content of the kth active ingredient This represents the quantified value of the l-th efficacy indicator for the i-th case. This represents the average value of the first efficacy indicator; The core analysis module's clinical efficacy quantitative evaluation unit references Western medicine efficacy evaluation standards and combines them with traditional Chinese medicine syndrome evaluation norms to design a comprehensive scoring formula for the clinical efficacy of traditional Chinese medicine, thereby achieving quantitative evaluation of efficacy. The quantitative evaluation calculation formula is as follows: ; in, Let p be the comprehensive clinical efficacy score for the i-th case; a higher score indicates better efficacy. p represents the number of efficacy indicators. The weight of the lth efficacy indicator, Let l be the normalized value of the l-th efficacy indicator for the i-th case. The weight of the k-th core effective ingredient. Let c be the normalized content of the k-th core active ingredient in the traditional Chinese medicine taken by the i-th patient, and c be the adverse reaction weighting coefficient. The adverse reaction quantification value for the i-th case is based on the comprehensive score. The efficacy is divided into four levels: E≥90 is excellent, 80≤E<90 is good, 60≤E<80 is effective, and E<60 is ineffective. The pilot-scale process optimization unit of the core analysis module optimizes the pilot-scale extraction process parameters based on the component extraction efficiency analysis results, using response surface methodology to comprehensively improve extraction efficiency. To determine the response value, a regression model is established between process parameters and extraction efficiency to solve for the optimal combination of process parameters.

[0011] A method for collecting and analyzing clinical efficacy data of traditional Chinese medicine based on multi-channel detection, the method being implemented using the multi-channel detection-based clinical efficacy data collection device for traditional Chinese medicine as described in claims 1-6, comprising the following steps: Step 1: Device initialization and parameter setting; Turn on the data acquisition device for clinical efficacy of traditional Chinese medicine, complete the self-test of each module, and ensure that the multi-channel synchronous acquisition module, the traditional Chinese medicine component extraction module, the data preprocessing module, and the core analysis module are working properly; set relevant parameters according to the testing requirements, including pilot-scale testing parameters and clinical application parameters; Pilot-scale testing parameters: Set extraction method, extraction temperature, extraction time, solvent concentration, stirring speed, and pressure parameters; set the detection index, detection accuracy, and sampling frequency of the component detection channel. Clinical application parameters: Set the list of clinical efficacy indicators, data entry specifications, and weighting relationships for efficacy evaluation; set the interface parameters with the hospital's electronic medical record system and clinical testing equipment to ensure synchronous data transmission. Step 2: Multi-channel synchronous data acquisition; Based on the set parameters, the multi-channel synchronous acquisition module is activated to complete the pilot-scale data acquisition and clinical data acquisition. Step 3: Data preprocessing; The data preprocessing module purifies, standardizes, and aligns the collected raw data. It uses the 3σ criterion to remove outliers and linear interpolation to supplement missing data to ensure data integrity. It also normalizes all data to eliminate the influence of dimensions. Based on the collection timestamp, it aligns the pilot-scale process parameters, component content data, clinical case information, and efficacy index data to form a sample data matrix, ensuring data correlation. Step 4: Core analysis of multi-source data; Multi-dimensional analysis was performed on the preprocessed sample data, including component extraction efficiency analysis, component content similarity analysis, component efficacy correlation analysis, quantitative evaluation of clinical efficacy, and optimization of pilot-scale process. Step 5: Results Display and Storage Sharing; The terminal display module displays various analysis results in real time, including extraction efficiency curves, component fingerprints, component-therapeutic effect correlation diagrams, clinical efficacy scoring tables, and process parameter optimization suggestions. The data storage module stores raw collected data, preprocessed data, analysis results, and operation logs both locally and in the cloud, supports data encryption and backup, and allows querying and exporting analysis results through the terminal or cloud platform, enabling data sharing among multiple institutions and personnel. Step 6: Device maintenance and data update; Regular maintenance of the device, including sensor calibration, extraction module cleaning, and detection unit calibration, is necessary to ensure the device's detection accuracy. Based on changes in the types of Chinese medicine and detection requirements, the detection indicators of effective components and the weighting coefficients for efficacy evaluation are updated, and the analysis algorithm is optimized to improve the device's applicability and analytical accuracy.

[0012] This invention provides a device and method for acquiring and analyzing clinical efficacy data of traditional Chinese medicine based on multi-channel detection. It has the following beneficial effects: 1. This invention provides a multi-channel detection-based device and analysis method for acquiring and analyzing clinical efficacy data of traditional Chinese medicine (TCM). It constructs an integrated multi-channel detection and data acquisition system for TCM, integrating four major functions: TCM component extraction, pilot-scale testing, clinical data acquisition, and efficacy analysis. This achieves standardized data acquisition throughout the entire process of TCM development, pilot-scale testing, and clinical application, filling the gap in the lack of a unified testing system for TCM similar to that for Western medicine. Simultaneously, it integrates various modern extraction and detection technologies, improving the standardization level of TCM component extraction and detection. Furthermore, it optimizes the extraction technology of effective components from TCM, integrating multiple extraction methods such as ultrasound, microwave, and supercritical fluid extraction. The optimal extraction scheme can be selected according to the type of TCM and the type of effective components, improving extraction efficiency and purity. At the same time, through extraction efficiency analysis and process optimization, it provides a scientific basis for pilot-scale production, ensuring the consistency of quality across different batches of TCM.

[0013] 2. This invention provides a data acquisition device and analysis method for clinical efficacy of traditional Chinese medicine (TCM) based on multi-channel detection. It establishes a standardized system for TCM clinical data acquisition and quantitative evaluation of efficacy, enabling simultaneous acquisition of case information, efficacy indicators, and component metabolism data. A scientific comprehensive efficacy scoring formula is designed to transform subjective symptoms into quantitative indicators, achieving accurate evaluation of TCM efficacy and aligning with the efficacy evaluation system of Western medicine. The device adopts a modular design, accommodating both pilot-scale testing and clinical application scenarios. It supports dual storage (local and cloud) and multi-terminal sharing of data. It is easy to operate, has high detection accuracy, and strong versatility, and can be widely applied in the research, development, production, and clinical application of Chinese herbal medicines and prepared Chinese medicines, promoting the modernization and internationalization of TCM. Attached Figure Description

[0014] Figure 1 This is a functional framework diagram of the traditional Chinese medicine clinical efficacy data acquisition device based on multi-channel detection according to the present invention. Figure 2 This is a flowchart of the analysis steps of the method for collecting and analyzing clinical efficacy data of traditional Chinese medicine based on multi-channel detection according to the present invention. Detailed Implementation

[0015] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Example 1:

[0016] like Figure 1 As shown in the figure, this embodiment of the invention provides a data acquisition device for clinical efficacy of traditional Chinese medicine based on multi-channel detection, including a multi-channel synchronous acquisition module, a traditional Chinese medicine component extraction module, a data preprocessing module, a core analysis module, a terminal display module, and a data storage module. The multi-channel synchronous acquisition module includes four independent acquisition channels: a pilot-scale process parameter acquisition channel, a traditional Chinese medicine component detection channel, a clinical basic data acquisition channel, and a clinical efficacy indicator acquisition channel. The multi-channel synchronous acquisition module is used to simultaneously acquire pilot-scale process parameters of traditional Chinese medicine, data on the content of effective components in traditional Chinese medicine, basic information on clinical cases, and clinical efficacy indicator data. The traditional Chinese medicine component extraction module is linked with the traditional Chinese medicine component detection channel to achieve simultaneous extraction of effective components of traditional Chinese medicine using multiple methods. It can select a single or combined extraction method according to the type of traditional Chinese medicine and the type of effective components, including an ultrasound-assisted extraction unit, a microwave-assisted extraction unit, a supercritical fluid extraction unit, and a solvent extraction unit. The data preprocessing module is used to clean, standardize, and eliminate noise interference from the raw data acquired by the multi-channel synchronous acquisition module. The specific processing steps include data cleaning, dimensional standardization, and data alignment. The core analysis module incorporates a multi-source data fusion algorithm and a quantitative analysis model, including a component extraction efficiency analysis unit, a component content similarity analysis unit, a component efficacy correlation analysis unit, a clinical efficacy quantitative evaluation unit, and a pilot-scale process optimization unit. The terminal display module is used to display the collected data, preprocessing results and core analysis results in real time, and supports data query, export and printing. The data storage module adopts a dual storage method of local solid-state hard disk and cloud, which is used to encrypt and store raw data, preprocessing data, analysis results and device operation logs, and supports data backup, recovery and multi-terminal sharing. The multi-channel synchronous acquisition module is equipped with a high-precision temperature sensor, pressure sensor, stirring speed sensor and solvent concentration sensor for the pilot-scale process parameter acquisition channel. It is used to collect process parameters such as extraction temperature, extraction time, solvent concentration, stirring speed and extraction pressure in the pilot-scale extraction process of traditional Chinese medicine in real time. The collected data is transmitted to the data preprocessing module in real time. The TCM component detection channel includes an ultrasound-assisted extraction unit, a microwave-assisted extraction unit, a supercritical fluid extraction unit, and a traditional solvent extraction unit. It also has a built-in extraction efficiency monitoring unit to monitor the dissolution of effective components in real time during the extraction process. When the dissolution reaches a stable value, the extraction is automatically stopped to avoid over-extraction that leads to an increase in impurities. At the same time, it records key parameters during the extraction process. The clinical basic data acquisition channel is used to collect basic information of clinical cases. Data is entered through a touch input unit or a wireless transmission unit, and the format is automatically checked after the data is entered. The clinical efficacy index collection channel is used to collect efficacy-related indicators of patients after medication, including physiological indicators, TCM syndrome indicators, and quality of life scale scores. The ultrasonic-assisted extraction unit of the traditional Chinese medicine component extraction module uses a high-frequency ultrasonic generator to release the effective components in the Chinese medicinal materials through the vibration and cavitation of ultrasonic waves, and accelerates the contact and dissolution of the solvent with the effective components. The microwave-assisted extraction unit uses a microwave generator to use the energy of microwaves to make the effective components in the Chinese medicinal materials expand and release due to heat. The supercritical fluid extraction unit uses CO2 as a supercritical fluid and utilizes the special properties of supercritical fluids to dissolve the effective components in the Chinese medicinal materials in the supercritical fluid. Then, by adjusting the pressure or temperature of the fluid, the effective components are selectively extracted. The solvent extraction unit uses traditional solvents for extraction, supports solvent concentration adjustment, and is equipped with a constant temperature stirring device. The data preprocessing module's data purification function uses the 3σ criterion to remove outliers. Assuming the data follows a normal distribution, it removes data that deviates from the mean by more than three times the standard deviation, i.e., data that satisfies |x-μ|>3σ, where x is the original value of the j-th indicator of the i-th sample, μ is the mean of the j-th indicator, and σ is the standard deviation of the j-th indicator. Missing data is supplemented using linear interpolation or mean imputation. The data preprocessing module standardizes the dimensions by normalizing the data to the [0,1] interval, eliminating the influence of dimensions. The normalization formula is as follows: ; in, Let j be the normalized value of the i-th indicator. Let j be the original value of the j-th indicator for the i-th sample. The maximum value of the j-th indicator. The minimum value of the j-th indicator; The data preprocessing module aligns synchronous data from different channels based on the acquisition timestamp to ensure that process parameters, component content, case information, and efficacy indicators of the same sample at the same time point correspond one-to-one, forming a complete sample data matrix. The component extraction efficiency analysis unit of the core analysis module calculates the extraction efficiency of effective components of traditional Chinese medicine based on the extraction parameters and component detection data collected by the extraction module, and optimizes the pilot-scale extraction process parameters. The extraction efficiency calculation formula is as follows: ; in, Let be the extraction efficiency of the k-th active ingredient. This represents the actual extraction amount (mg) of the kth active ingredient after extraction. The total content of the kth active ingredient in the raw material; Simultaneously, the overall extraction efficiency is calculated, taking into account the extraction of multiple effective components. The calculation formula is as follows: ; in, To determine the overall extraction efficiency, n represents the number of types of active ingredients. The weighting coefficient for the k-th effective ingredient; The component content similarity analysis unit of the core analysis module calculates the component similarity of different batches of traditional Chinese medicine based on the fingerprint spectrum data collected by the component detection channel, and evaluates the consistency of the quality of traditional Chinese medicine. It uses a cosine similarity algorithm, and the calculation formula is as follows: ; Where S represents the similarity of the components of the i-th batch and the j-th batch of traditional Chinese medicine. The closer S is to 1, the better the consistency of the components between the two batches of traditional Chinese medicine. Let be the peak area of ​​the k-th characteristic peak of the i-th batch of traditional Chinese medicine. Let n be the peak area of ​​the kth characteristic peak of the jth batch of traditional Chinese medicine, and n be the number of characteristic peaks. The component-therapeutic efficacy correlation analysis unit of the core analysis module establishes a correlation model between the content of effective components of traditional Chinese medicine and clinical efficacy indicators based on preprocessed multi-source data. Pearson correlation analysis is used to calculate the correlation coefficient between component content and efficacy indicators. The calculation formula is as follows: ; in Let r be the correlation coefficient between the content of the k-th effective ingredient and the l-th efficacy indicator. r>0 indicates a positive correlation, r<0 indicates a negative correlation, and the closer |r| is to 1, the stronger the correlation. m is the number of clinical case samples. The content of the k-th effective ingredient in the i-th case. The average content of the kth active ingredient This represents the quantified value of the l-th efficacy indicator for the i-th case. This represents the average value of the first efficacy indicator; The core analysis module's clinical efficacy quantitative evaluation unit references Western medicine efficacy evaluation standards and combines them with traditional Chinese medicine syndrome evaluation norms to design a comprehensive scoring formula for the clinical efficacy of traditional Chinese medicine, thereby achieving quantitative evaluation of efficacy. The quantitative evaluation calculation formula is as follows: ; in, Let p be the comprehensive clinical efficacy score for the i-th case; a higher score indicates better efficacy. p represents the number of efficacy indicators. The weight of the lth efficacy indicator, Let l be the normalized value of the l-th efficacy indicator for the i-th case. The weight of the k-th core effective ingredient. Let c be the normalized content of the k-th core active ingredient in the traditional Chinese medicine taken by the i-th patient, and c be the adverse reaction weighting coefficient. The adverse reaction quantification value for the i-th case is based on the comprehensive score. The efficacy is divided into four levels: E≥90 is excellent, 80≤E<90 is good, 60≤E<80 is effective, and E<60 is ineffective. The pilot-scale process optimization unit of the core analysis module optimizes the pilot-scale extraction process parameters based on the component extraction efficiency analysis results, using response surface methodology to comprehensively improve extraction efficiency. To determine the response value, a regression model is established between process parameters and extraction efficiency to solve for the optimal combination of process parameters. Example 2:

[0017] like Figure 2As shown in the figure, this embodiment of the invention provides a method for collecting clinical efficacy data of traditional Chinese medicine based on multi-channel detection, including the following steps: Step 1: Device initialization and parameter setting; Turn on the data acquisition device for clinical efficacy of traditional Chinese medicine, complete the self-test of each module, and ensure that the multi-channel synchronous acquisition module, the traditional Chinese medicine component extraction module, the data preprocessing module, and the core analysis module are working properly; set relevant parameters according to the testing requirements, including pilot-scale testing parameters and clinical application parameters; Pilot-scale testing parameters: Set extraction method, extraction temperature, extraction time, solvent concentration, stirring speed, and pressure parameters; set the detection index, detection accuracy, and sampling frequency of the component detection channel. Clinical application parameters: Set the list of clinical efficacy indicators, data entry specifications, and weighting relationships for efficacy evaluation; set the interface parameters with the hospital's electronic medical record system and clinical testing equipment to ensure synchronous data transmission. Step 2: Multi-channel synchronous data acquisition; Based on the set parameters, the multi-channel synchronous acquisition module is activated to complete the pilot-scale data acquisition and clinical data acquisition. Step 3: Data preprocessing; The data preprocessing module purifies, standardizes, and aligns the collected raw data. It uses the 3σ criterion to remove outliers and linear interpolation to supplement missing data to ensure data integrity. It also normalizes all data to eliminate the influence of dimensions. Based on the collection timestamp, it aligns the pilot-scale process parameters, component content data, clinical case information, and efficacy index data to form a sample data matrix, ensuring data correlation. Step 4: Core analysis of multi-source data; Multi-dimensional analysis was performed on the preprocessed sample data, including component extraction efficiency analysis, component content similarity analysis, component efficacy correlation analysis, quantitative evaluation of clinical efficacy, and optimization of pilot-scale process. Step 5: Results Display and Storage Sharing; The terminal display module displays various analysis results in real time, including extraction efficiency curves, component fingerprints, component-therapeutic effect correlation diagrams, clinical efficacy scoring tables, and process parameter optimization suggestions. The data storage module stores raw collected data, preprocessed data, analysis results, and operation logs both locally and in the cloud, supports data encryption and backup, and allows querying and exporting analysis results through the terminal or cloud platform, enabling data sharing among multiple institutions and personnel. Step 6: Device maintenance and data update; Regular maintenance of the device, including sensor calibration, extraction module cleaning, and detection unit calibration, is necessary to ensure the device's detection accuracy. Based on changes in the types of Chinese medicine and detection requirements, the detection indicators of effective components and the weighting coefficients for efficacy evaluation are updated, and the analysis algorithm is optimized to improve the device's applicability and analytical accuracy.

[0018] The following points should be noted in this article: 1. The accompanying drawings of the embodiments disclosed herein only relate to the structures involved in the embodiments disclosed herein; other structures can be referred to in general design.

[0019] 2. Where there is no conflict, the embodiments of this disclosure and the features in the embodiments can be combined with each other to obtain new embodiments.

[0020] Although embodiments of the present invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without inventive effort are within the scope of protection of the present invention.

Claims

1. A data acquisition device for clinical efficacy of traditional Chinese medicine based on multi-channel detection, comprising a multi-channel synchronous acquisition module, a traditional Chinese medicine component extraction module, a data preprocessing module, a core analysis module, a terminal display module, and a data storage module, characterized in that: The multi-channel synchronous acquisition module includes four independent acquisition channels: a pilot-scale process parameter acquisition channel, a traditional Chinese medicine component detection channel, a clinical basic data acquisition channel, and a clinical efficacy indicator acquisition channel. The multi-channel synchronous acquisition module is used to simultaneously acquire process parameters of traditional Chinese medicine in the pilot-scale stage, data on the content of effective components of traditional Chinese medicine, basic information on clinical cases, and clinical efficacy indicator data. The traditional Chinese medicine component extraction module is linked with the traditional Chinese medicine component detection channel to achieve simultaneous extraction of effective components of traditional Chinese medicine using multiple methods. It can select a single or combined extraction method according to the type of traditional Chinese medicine and the type of effective components, including an ultrasound-assisted extraction unit, a microwave-assisted extraction unit, a supercritical fluid extraction unit, and a solvent extraction unit. The data preprocessing module is used to clean, standardize, and eliminate noise interference from the raw data acquired by the multi-channel synchronous acquisition module. The specific processing steps include data cleaning, dimensional standardization, and data alignment. The core analysis module incorporates a multi-source data fusion algorithm and a quantitative analysis model, including a component extraction efficiency analysis unit, a component content similarity analysis unit, a component efficacy correlation analysis unit, a clinical efficacy quantitative evaluation unit, and a pilot-scale process optimization unit. The terminal display module is used to display the collected data, preprocessing results and core analysis results in real time, and supports data query, export and printing. The data storage module adopts a dual storage method of local solid-state drive and cloud, which is used to encrypt and store raw data, preprocessed data, analysis results and device operation logs, and supports data backup, recovery and multi-terminal sharing.

2. The device for acquiring clinical efficacy data of traditional Chinese medicine based on multi-channel detection according to claim 1, characterized in that: The multi-channel synchronous acquisition module is equipped with a high-precision temperature sensor, pressure sensor, stirring speed sensor and solvent concentration sensor for the pilot-scale process parameter acquisition channel. It is used to collect process parameters such as extraction temperature, extraction time, solvent concentration, stirring speed and extraction pressure in the pilot-scale extraction process of traditional Chinese medicine in real time. The collected data is transmitted to the data preprocessing module in real time. The TCM component detection channel includes an ultrasound-assisted extraction unit, a microwave-assisted extraction unit, a supercritical fluid extraction unit, and a traditional solvent extraction unit. It also has a built-in extraction efficiency monitoring unit to monitor the dissolution of effective components in real time during the extraction process. When the dissolution reaches a stable value, the extraction is automatically stopped to avoid over-extraction that leads to an increase in impurities. At the same time, it records key parameters during the extraction process. The clinical basic data acquisition channel is used to collect basic information of clinical cases. Data is entered through a touch input unit or a wireless transmission unit, and the format is automatically checked after the data is entered. The clinical efficacy indicator collection channel is used to collect efficacy-related indicators of patients after medication, including physiological indicators, TCM syndrome indicators, and quality of life scale scores.

3. The device for acquiring clinical efficacy data of traditional Chinese medicine based on multi-channel detection according to claim 1, characterized in that: The ultrasonic-assisted extraction unit of the traditional Chinese medicine component extraction module uses a high-frequency ultrasonic generator to release the effective components in the medicinal materials through the vibration and cavitation of ultrasonic waves, and accelerates the contact and dissolution of the solvent with the effective components. The microwave-assisted extraction unit uses a microwave generator to use the energy of microwaves to heat and expand the effective components in the medicinal materials and release them. The supercritical fluid extraction unit uses CO2 as the supercritical fluid and utilizes the special properties of supercritical fluids to dissolve the effective components in the medicinal materials. Then, by adjusting the pressure or temperature of the fluid, the effective components are selectively extracted. The solvent extraction unit uses traditional solvents for extraction, supports solvent concentration adjustment, and is equipped with a constant temperature stirring device.

4. The device for acquiring clinical efficacy data of traditional Chinese medicine based on multi-channel detection according to claim 1, characterized in that: The data preprocessing module's data purification function uses the 3σ criterion to remove outliers. Assuming the data follows a normal distribution, it removes data that deviates from the mean by more than three times the standard deviation, i.e., data that satisfies |x-μ|>3σ, where x is the original value of the j-th indicator of the i-th sample, μ is the mean of the j-th indicator, and σ is the standard deviation of the j-th indicator. Missing data is supplemented using linear interpolation or mean imputation. The data preprocessing module standardizes the dimensions by normalizing the data to the [0,1] interval, eliminating the influence of dimensions. The normalization formula is as follows: ; in, Let j be the normalized value of the i-th indicator. Let j be the original value of the j-th indicator for the i-th sample. The maximum value of the j-th indicator. The minimum value of the j-th indicator; The data preprocessing module aligns synchronous data from different channels based on the acquisition timestamp, ensuring that process parameters, component content, case information, and efficacy indicators of the same sample at the same time point correspond one-to-one, forming a complete sample data matrix.

5. The device for acquiring clinical efficacy data of traditional Chinese medicine based on multi-channel detection according to claim 1, characterized in that: The component extraction efficiency analysis unit of the core analysis module calculates the extraction efficiency of effective components of traditional Chinese medicine based on the extraction parameters and component detection data collected by the extraction module, and optimizes the pilot-scale extraction process parameters. The extraction efficiency calculation formula is as follows: ; in, Let be the extraction efficiency of the k-th active ingredient. This represents the actual extraction amount (mg) of the kth active ingredient after extraction. The total content of the kth active ingredient in the raw material; Simultaneously, the overall extraction efficiency is calculated, taking into account the extraction of multiple effective components. The calculation formula is as follows: ; in, To determine the overall extraction efficiency, n represents the number of types of active ingredients. The weighting coefficient for the k-th effective ingredient; The component content similarity analysis unit of the core analysis module calculates the component similarity of different batches of traditional Chinese medicine based on the fingerprint spectrum data collected by the component detection channel, and evaluates the consistency of the quality of traditional Chinese medicine. It uses a cosine similarity algorithm, and the calculation formula is as follows: ; Where S represents the similarity of the components of the i-th batch and the j-th batch of traditional Chinese medicine. The closer S is to 1, the better the consistency of the components between the two batches of traditional Chinese medicine. Let be the peak area of ​​the k-th characteristic peak of the i-th batch of traditional Chinese medicine. Let n be the peak area of ​​the kth characteristic peak of the jth batch of traditional Chinese medicine, and n be the number of characteristic peaks.

6. The device for acquiring clinical efficacy data of traditional Chinese medicine based on multi-channel detection according to claim 1, characterized in that: The component-therapeutic efficacy correlation analysis unit of the core analysis module establishes a correlation model between the content of effective components of traditional Chinese medicine and clinical efficacy indicators based on preprocessed multi-source data. Pearson correlation analysis is used to calculate the correlation coefficient between component content and efficacy indicators. The calculation formula is as follows: ; in Let r be the correlation coefficient between the content of the k-th effective ingredient and the l-th efficacy indicator. r>0 indicates a positive correlation, r<0 indicates a negative correlation, and the closer |r| is to 1, the stronger the correlation. m is the number of clinical case samples. The content of the k-th effective ingredient in the i-th case. The average content of the kth active ingredient This represents the quantified value of the l-th efficacy indicator for the i-th case. This represents the average value of the first efficacy indicator; The core analysis module's clinical efficacy quantitative evaluation unit references Western medicine efficacy evaluation standards and combines them with traditional Chinese medicine syndrome evaluation norms to design a comprehensive scoring formula for the clinical efficacy of traditional Chinese medicine, thereby achieving quantitative evaluation of efficacy. The quantitative evaluation calculation formula is as follows: ; in, Let p be the comprehensive clinical efficacy score for the i-th case; a higher score indicates better efficacy. p represents the number of efficacy indicators. The weight of the lth efficacy indicator, Let l be the normalized value of the l-th efficacy indicator for the i-th case. The weight of the k-th core effective ingredient. Let c be the normalized content of the k-th core active ingredient in the traditional Chinese medicine taken by the i-th patient, and c be the adverse reaction weighting coefficient. The adverse reaction quantification value for the i-th case is based on the comprehensive score. The efficacy is divided into four levels: E≥90 is excellent, 80≤E<90 is good, 60≤E<80 is effective, and E<60 is ineffective. The pilot-scale process optimization unit of the core analysis module optimizes the pilot-scale extraction process parameters based on the component extraction efficiency analysis results, using response surface methodology to comprehensively improve extraction efficiency. To determine the response value, a regression model is established between process parameters and extraction efficiency to solve for the optimal combination of process parameters.

7. A method for collecting and analyzing clinical efficacy data of traditional Chinese medicine based on multi-channel detection, characterized in that: The method is implemented using the multi-channel detection-based traditional Chinese medicine clinical efficacy data acquisition device described in claims 1-6, and includes the following steps: Step 1: Device initialization and parameter setting; Turn on the data acquisition device for clinical efficacy of traditional Chinese medicine, complete the self-test of each module, and ensure that the multi-channel synchronous acquisition module, the traditional Chinese medicine component extraction module, the data preprocessing module, and the core analysis module are working properly; set relevant parameters according to the testing requirements, including pilot-scale testing parameters and clinical application parameters; Pilot-scale testing parameters: Set extraction method, extraction temperature, extraction time, solvent concentration, stirring speed, and pressure parameters; set the detection index, detection accuracy, and sampling frequency of the component detection channel. Clinical application parameters: Set the list of clinical efficacy indicators, data entry specifications, and weighting relationships for efficacy evaluation; set the interface parameters with the hospital's electronic medical record system and clinical testing equipment to ensure synchronous data transmission. Step 2: Multi-channel synchronous data acquisition; Based on the set parameters, the multi-channel synchronous acquisition module is activated to complete the pilot-scale data acquisition and clinical data acquisition. Step 3: Data preprocessing; The data preprocessing module purifies, standardizes, and aligns the collected raw data. It uses the 3σ criterion to remove outliers and linear interpolation to supplement missing data to ensure data integrity. It also normalizes all data to eliminate the influence of dimensions. Based on the collection timestamp, it aligns the pilot-scale process parameters, component content data, clinical case information, and efficacy index data to form a sample data matrix, ensuring data correlation. Step 4: Core analysis of multi-source data; Multi-dimensional analysis was performed on the preprocessed sample data, including component extraction efficiency analysis, component content similarity analysis, component efficacy correlation analysis, quantitative evaluation of clinical efficacy, and optimization of pilot-scale process. Step 5: Results Display and Storage Sharing; The terminal display module displays various analysis results in real time, including extraction efficiency curves, component fingerprints, component-therapeutic effect correlation diagrams, clinical efficacy scoring tables, and process parameter optimization suggestions. The data storage module stores raw collected data, preprocessed data, analysis results, and operation logs both locally and in the cloud, supports data encryption and backup, and allows querying and exporting analysis results through the terminal or cloud platform, enabling data sharing among multiple institutions and personnel. Step 6: Device maintenance and data update; Regular maintenance of the device, including sensor calibration, extraction module cleaning, and detection unit calibration, is necessary to ensure the device's detection accuracy. Based on changes in the types of Chinese medicine and detection requirements, the detection indicators of effective components and the weighting coefficients for efficacy evaluation are updated, and the analysis algorithm is optimized to improve the device's applicability and analytical accuracy.

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