Analysis and detection method of polymyxin B sulfate

Abstract

The invention belongs to the technical field of analysis and detection of polymyxin B sulfate, and provides an analysis and detection method of polymyxin B. In a historical detection period, historical column efficiency values of a chromatographic column when the polymyxin B sulfate is analyzed and detected for multiple times are recorded, trend change analysis is carried out, whether the column efficiency is reduced or not is judged, and whether the column efficiency is reduced or not is judged. If the overall column efficiency in the historical detection period is in a descending trend, identifying the change trend type of a plurality of column efficiency values, and according to the identified change trend type, obtaining the predicted column life loss degree and the current column efficiency value of the current chromatographic column for analyzing and detecting the polymyxin B sulfate; and calculating the ratio of the current column efficiency value to the predicted column life loss degree to obtain a predicted residual column life value, thereby solving the problem that the service life of the chromatographic column cannot be accurately known in analysis and detection of polymyxin B sulfate.

Description

Technical Field

[0001] The present invention belongs to the technical field of analysis and detection of polymyxin B sulfate, and specifically relates to an analysis and detection method for polymyxin B sulfate. Background Art

[0002] Polymyxin B sulfate is an important drug. In its quality control and research, accurate analysis and detection are crucial. As a key component in analysis and detection, the change in the column efficiency of the chromatographic column will have a significant impact on the detection results of polymyxin B sulfate.

[0003] In the above-mentioned prior art, in the analysis and detection of polymyxin B sulfate, there is a lack of effective methods for monitoring the column efficiency of the chromatographic column and evaluating its influence on the detection resolution. At the same time, it is difficult to accurately predict the service life of the chromatographic column, which may lead to inaccurate detection results, low experimental efficiency, and waste of resources; Therefore, this application records the historical column efficiency values when the chromatographic column analyzes and detects polymyxin B sulfate multiple times, and conducts trend change analysis to determine whether the column efficiency has decreased. If the overall column efficiency shows a downward trend within the historical detection period, then identify the change trend types of multiple column efficiency values, indirectly reflecting the change of the overall trend of the historical column efficiency change curve. Moreover, according to the identified change trend types, a column life prediction model is constructed, so as to provide data support for inferring the corresponding column efficiency of the chromatographic column in the later stage. And by dividing the constructed historical separation change curve to obtain historical separation sub-lines, iterative fitting analysis is carried out, selecting the fitting line with a high fitting matching degree, and obtaining the corresponding slope as the slope of the historical separation sub-line, which helps to improve the characterization accuracy of the slope of the historical separation sub-line, and at the same time reflects that it has a high important weight ratio in the aspect of the detection accuracy of the content of polymyxin B sulfate. Therefore, the importance of the column efficiency of the chromatographic column itself is emphasized; According to the identified change trend types, obtain the predicted column life loss degree and the current column efficiency value of the current chromatographic column for analyzing and detecting polymyxin B sulfate, and obtain the predicted remaining column life value, solving the problem that in the analysis and detection of polymyxin B sulfate, the service life of the chromatographic column cannot be accurately known. By predicting the service life of the chromatographic column, it helps the experimenters to understand the usage status of the chromatographic column in advance, replace the chromatographic column in time, ensure the accuracy and reliability of the analysis and detection results of polymyxin B sulfate, avoid affecting the detection accuracy due to the aging of the chromatographic column, and at the same time can reasonably arrange the experimental process and improve the experimental efficiency.

[0004] For this reason, the present invention provides an analysis and detection method for polymyxin B sulfate. Summary of the Invention

[0005] In order to make up for the deficiencies of the prior art and solve at least one of the technical problems proposed in the background art.

[0006] The technical solution adopted by the present invention to solve its technical problems is as follows: An analytical detection method for polymyxin B sulfate, comprising the following steps: During the historical detection period, record the historical column efficiency values of multiple chromatographic column analyses and detections of polymyxin B sulfate, and conduct a trend change analysis to determine whether the column efficiency has decreased; If the column efficiency of the chromatographic column decreases, analyze the change trend type of the column efficiency value corresponding to the polymyxin B sulfate analysis and detection operation to determine the column efficiency change trend type; Among them, the change trend types include a stable decline type or a fluctuating decline type; During the historical detection period, obtain the historical resolution after each analysis and detection operation, and analyze the correlation with the historical column efficiency value to evaluate the influence degree of the column efficiency corresponding to the chromatographic column on the detection resolution; If the influence degree is large, according to the identified change trend type, obtain the predicted column life loss degree, and the column efficiency value of the current chromatographic column for analyzing and detecting polymyxin B sulfate, and conduct a combined analysis to obtain the predicted remaining column life value.

[0007] As a preferred solution of the present invention: the method for obtaining the historical column efficiency value is as follows: Respectively obtain the half-peak width and retention time on the liquid chromatograph corresponding to the chromatographic column analysis and detection operation, and input them into the theoretical plate number calculation formula to output the historical column efficiency value.

[0008] As a preferred solution of the present invention: the process of conducting a trend change analysis on the historical column efficiency values of multiple chromatographic column analysis and detection operations is as follows: Evenly divide the historical detection period into several historical detection time periods; Extract the historical column efficiency values within each detection time period, and construct a historical column efficiency change curve according to the time series of the corresponding time periods, and divide it into several historical column efficiency sub-curves; On the historical column efficiency sub-curve, randomly extract two corresponding coordinates, and perform simulation fitting through the least squares method to obtain a simulated column efficiency fitting line, and obtain the area of the closed figure formed by the corresponding historical column efficiency sub-curve, and perform a summation calculation to obtain the fitting column efficiency matching degree. If it is less than or equal to the standard fitting matching degree, use the simulated fitting line as the column efficiency reference line, and calculate the slope of the historical column efficiency sub-curve through the slope calculation formula.

[0009] As a preferred solution of the present invention: the process of determining whether the column efficiency has decreased is as follows: Count the number of historical column efficiency sub-fitting lines with a negative slope of the historical column efficiency sub-curve and the number of historical column efficiency sub-fitting lines with a positive slope of the historical column efficiency sub-curve; If the number of historical column efficiency sub-fitting lines with a negative slope of the sub-fitting line is greater than the number of historical column efficiency sub-fitting lines with a positive slope of the sub-fitting line, a column efficiency decrease signal is generated.

[0010] As a preferred solution of the present invention: the recognition process of the change trend type is as follows: Combine the slopes of adjacent historical column efficiency sub-curves to obtain multiple sub-curve slope groups, and process the slopes of the historical column efficiency sub-curves within the multiple sub-curve slope groups through the Mahalanobis distance formula to obtain a trend type recognition value; If the trend type recognition value is greater than the trend type recognition threshold, it is a fluctuating decrease type; If the trend type recognition value is less than or equal to the trend type recognition threshold, it is a stable decrease type.

[0011] As a preferred solution of the present invention: the process of obtaining the historical resolution is as follows: During any historical detection period, obtain the content of polymyxin B sulfate after extraction, and calculate the ratio with the content of the extraction solution before extraction to obtain the historical resolution.

[0012] As a preferred solution of the present invention: analyze the correlation between the detection resolution and the historical column efficiency value, and the process is as follows: Extract the historical resolution and historical column efficiency values during all historical detection periods respectively; Based on the historical resolution during all historical detection periods, construct a historical resolution change curve and divide it into several historical resolution sub-curves; On the historical resolution sub-curve, randomly extract two corresponding coordinates, and perform simulation fitting through the least squares method to obtain a simulated resolution fitting line, and sum the areas of all closed figures formed by the historical resolution sub-curves to obtain a fitting resolution matching degree. If it is less than or equal to the standard fitting matching degree, use the simulated fitting line as the resolution reference line, and calculate the slope of the historical resolution sub-curve through the slope calculation formula; Based on the same historical detection period as the reference, extract the slopes of the corresponding historical resolution sub-curves and the slopes of the historical column efficiency sub-curves respectively, and process the slopes of the historical resolution sub-curves and the slopes of the historical column efficiency sub-curves corresponding to all historical detection periods according to the historical detection period through the Mahalanobis distance formula, and output the column efficiency-resolution correlation degree.

[0013] As a preferred solution of the present invention: evaluate the influence degree of the column efficiency value corresponding to the chromatographic column on the detection resolution, and the process is as follows: If the column efficiency-resolution correlation degree is greater than the preset standard correlation degree, generate a small signal of low column efficiency influence; If the column efficiency-resolution correlation degree is less than or equal to the preset standard correlation degree, generate a large signal of high column efficiency influence.

[0014] A preferred embodiment of the present invention is as follows: The process of obtaining the column life loss degree is as follows: If it is a type of fluctuating decline, the Y-axis coordinates of adjacent coordinate points on the historical column efficiency change curve are subjected to difference processing to output the adjacent decline difference. The maximum adjacent decline difference and the minimum adjacent decline difference are extracted for averaging calculation, and the predicted column life loss degree is output; If it is a type of stable decline, the Y-axis coordinates of adjacent coordinate points on the historical column efficiency change curve are subjected to difference processing to output the adjacent decline difference; All adjacent decline differences are subjected to averaging calculation to output the predicted column life loss degree.

[0015] A preferred embodiment of the present invention is as follows: The process of obtaining the predicted remaining column life value is as follows: The current column efficiency value is divided by the predicted column life loss degree to obtain the predicted remaining column life value.

[0016] The beneficial effects of the present invention are as follows: 1. In the historical detection period of the present invention, the historical column efficiency values during multiple analyses and detections of polymyxin B sulfate by the chromatographic column are recorded, and trend change analysis is performed to determine whether the column efficiency decreases. If the column efficiency in the historical detection period shows an overall downward trend, the change trend types of multiple column efficiency values are identified, which not only indirectly reflects the change of the overall trend of the historical column efficiency change curve, but also can intuitively reflect the difference degree between different sub-curve slope groups. Furthermore, it helps to classify and identify the trend types of the historical column efficiency change curve, provides an important basis for constructing a column life prediction model, and constructs a column life prediction model according to the identified change trend type, thereby providing data support for inferring the corresponding column efficiency of the chromatographic column in the later stage; 2. In the historical detection period of the present invention, the historical resolution after each analysis and detection is obtained. The historical separation sub-curve is obtained by dividing the constructed historical separation change curve, and iterative fitting analysis is performed. The fitting line with a high fitting matching degree is selected, and the corresponding slope is obtained as the slope of the historical separation sub-curve, which helps to improve the characterization accuracy of the slope of the historical separation sub-curve. Based on the same historical detection period, the slopes of the corresponding historical separation sub-curves and historical column efficiency sub-curves are respectively extracted and compared for correlation. If the correlation is large, it indicates that the column efficiency of the chromatographic column itself is of high importance in the analysis and detection of polymyxin B sulfate, especially in terms of the accuracy of the content detection of polymyxin B sulfate, and has a high important weight ratio. Therefore, the importance of the column efficiency of the chromatographic column itself is emphasized; 3. According to the identified change trend type, the present invention obtains the predicted column life loss degree and the current column efficiency value of the current chromatographic column for the analysis and detection of polymyxin B sulfate, calculates the ratio of the current column efficiency value to the predicted column life loss degree to obtain the predicted remaining column life value, solves the problem that in the analysis and detection of polymyxin B sulfate, the service life of the chromatographic column cannot be accurately known. By predicting the service life of the chromatographic column, it helps the experimenters to understand the usage status of the chromatographic column in advance, replace the chromatographic column in time, ensure the accuracy and reliability of the analysis and detection results of polymyxin B sulfate, avoid affecting the detection accuracy due to chromatographic column aging, and at the same time can reasonably arrange the experimental process and improve the experimental efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The present invention will be further described below with reference to the accompanying drawings.

[0018] Figure 1 It is the flow chart of the idea of an analysis and detection method for polymyxin B sulfate of the present invention. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0019] In order to make the technical means, creative features, achieved purposes and effects of the present invention easy to understand, the present invention will be further described below in conjunction with specific embodiments.

[0020] Example 1

[0021] Please refer to Figure 1 As shown, an analysis and detection method for polymyxin B sulfate according to an embodiment of the present invention includes the following steps: Step 1: During the historical detection period, record the historical column efficiency values when the chromatographic column analyzes and detects polymyxin B sulfate multiple times, and perform trend change analysis to determine whether the column efficiency decreases; In a preferred embodiment, the process of obtaining the historical column efficiency value is as follows: Extract the liquid chromatography when the chromatographic column analyzes and detects polymyxin B sulfate each time; Use Shimadzu LC Solution software to obtain the semi-peak width and retention time on the liquid chromatography respectively, and input them into the theoretical plate number calculation formula: to obtain the historical column efficiency value , where represents the retention time, represents the semi-peak width; Evenly divide the historical detection period into several historical detection time periods; Extract the historical column efficiency values within each detection time period, and construct a historical column efficiency change curve according to the time series of the corresponding time periods, where the X-axis is time and the Y-axis is the historical column efficiency value; Divide the historical column efficiency change curve into several historical column efficiency sub-curves; It should be noted that the historical column efficiency sub - curve is divided by taking the local historical column efficiency change curve between adjacent coordinates on the historical column efficiency change curve as the historical column efficiency sub - curve; It should be noted that the number of historical column efficiency sub - curves is odd; On the historical column efficiency sub - curve, any two corresponding coordinates are extracted and simulated and fitted by the least - squares method to obtain the simulated column efficiency fitting line; The closed figure formed by the simulated column efficiency fitting line and the corresponding historical column efficiency sub - curve is extracted, and the sum of the areas of the closed figures is calculated to obtain the fitting column efficiency matching degree; It can be understood that the meaning represented by the fitting column efficiency matching degree is: the sum of the areas of all closed figures formed between the historical column efficiency sub - curve and the simulated column efficiency fitting line, which is a quantitative index used to evaluate the fitting degree of the simulated column efficiency fitting line to the historical column efficiency sub - curve. Specifically, the smaller the fitting column efficiency matching degree, the smaller the difference between the historical column efficiency sub - curve and the simulated column efficiency fitting line; the larger the fitting column efficiency matching degree, the larger the difference between the historical column efficiency sub - curve and the simulated column efficiency fitting line; If the fitting column efficiency matching degree is greater than the standard fitting matching degree, it indicates that the difference between the historical column efficiency sub - curve and the simulated column efficiency fitting line is large and the matching degree is low. Iterative simulation and fitting operations need to be performed on the simulated column efficiency fitting line until the fitting column efficiency matching degree is less than or equal to the standard fitting matching degree; If the fitting column efficiency matching degree is less than or equal to the standard fitting matching degree, it indicates that the difference between the historical column efficiency sub - curve and the simulated column efficiency fitting line is small and the matching degree is high. The simulated fitting line is used as the column efficiency reference line, and the slope of the historical column efficiency sub - curve is calculated through the slope calculation formula; It should be noted that the slopes of multiple historical column efficiency sub - curves are not zero; Count the number of historical column efficiency sub - fitting lines with a negative slope of the historical column efficiency sub - curve and the number of historical column efficiency sub - fitting lines with a positive slope of the historical column efficiency sub - curve; If the number of historical column efficiency sub - fitting lines with a negative slope of the sub - fitting line is greater than the number of historical column efficiency sub - fitting lines with a positive slope of the sub - fitting line, it indicates that the overall historical column efficiency change curve shows a downward trend, and a column efficiency decline signal is generated; If the number of historical column efficiency sub - fitting lines with a negative slope of the sub - fitting line is less than the number of historical column efficiency sub - fitting lines with a positive slope of the sub - fitting line, it indicates that the overall historical column efficiency change curve does not show a downward trend, and a non - column efficiency decline signal is generated; Step 2: If the column efficiency of the chromatographic column declines, analyze the change trend type of the column efficiency values corresponding to multiple chromatographic column analysis and detection operations to judge the column efficiency change trend type; Among them, the change trend types include but are not limited to the stable decline type or the fluctuating decline type; Exemplarily, sort all the slopes of the historical column efficiency sub-curves according to their sorting on the historical column efficiency change curve after being divided by the corresponding historical column efficiency sub-curves, and combine the slopes of adjacent historical column efficiency sub-curves to obtain multiple sub-curve slope groups; Process the slopes of the historical column efficiency sub-curves within multiple sub-curve slope groups through the Lance distance formula to obtain trend type identification values ; Specifically, the Lance distance formula: , where represents one of the slopes of the historical column efficiency sub-curves within the th sub-curve slope group, represents another slope of the historical column efficiency sub-curves within the th sub-curve slope group, represents the total number of sub-curve slope groups; It should be noted that the purpose of using the Lance distance formula is that: the Lance distance formula can quantify the differences between the slopes of the historical column efficiency sub-curves within the sub-curve slope group. Through the calculated trend type identification values, the difference degree between different sub-curve slope groups can be intuitively reflected. By comparing different slopes of the historical column efficiency sub-curves, it helps to identify the trend type of the historical column efficiency change curve, thus providing data support for inferring the corresponding column efficiency of the chromatographic column in the later stage; It can be understood that the meaning represented by the trend type identification value is: since the slope of the historical column efficiency sub-curve reflects the change trend of the historical column efficiency change curve in different parts, the trend type identification value not only indirectly reflects the change of the overall trend of the historical column efficiency change curve, but also can intuitively reflect the difference degree between different sub-curve slope groups, thus helping to classify and identify the trend type of the historical column efficiency change curve and providing an important basis for constructing the column life prediction model; Compare the trend type identification value with the trend type identification threshold, and the process is as follows: If the trend type identification value is greater than the trend type identification threshold, it indicates that the slope change of the historical column efficiency change curve in different stages is relatively large, and the overall downward trend has fluctuations, so it is the fluctuating downward type; If the trend type identification value is less than or equal to the trend type identification threshold, it indicates that the slope change of the historical column efficiency change curve in different stages is relatively small, and the overall downward trend is relatively stable, so it is the stable downward type; Specifically, in this embodiment, during the historical detection period, the historical column efficiency values during multiple analyses and detections of polymyxin B sulfate by the chromatographic column are recorded, and trend change analysis is performed to determine whether the column efficiency decreases. If the overall column efficiency shows a downward trend during the historical detection period, the change trend types of multiple column efficiency values are identified, which can not only indirectly reflect the change of the overall trend of the historical column efficiency change curve, but also intuitively reflect the difference degree between different sub-curve slope groups. Furthermore, it helps to classify and identify the trend types of the historical column efficiency change curve, provides an important basis for constructing a column life prediction model, and constructs a column life prediction model according to the identified change trend types, so as to provide data support for inferring the corresponding column efficiency of the chromatographic column in the later stage.

[0022] Embodiment 2

[0023] As Figure 1 shown, an analysis and detection method for polymyxin B sulfate according to an embodiment of the present invention includes the following steps: Step 3: During the historical detection period, obtain the historical resolution after each analysis and detection, analyze the correlation between the detection resolution and the historical column efficiency value, and evaluate the influence degree of the column efficiency value corresponding to the chromatographic column on the detection resolution; In a preferred embodiment, the process of obtaining the historical resolution is as follows: During any historical detection period, obtain the content of polymyxin B sulfate after extraction, and perform ratio calculation with the content of the extraction solution before extraction to obtain the historical resolution; It should be noted that the content of the extraction solution before extraction includes, but is not limited to, the content of the common extraction solution known to those skilled in the art during the extraction of polymyxin B sulfate; Extract the historical resolution and historical column efficiency values in all historical detection periods respectively; Based on the historical resolution in all historical detection periods, construct a historical resolution change curve; Divide the historical resolution change curve into several historical sub-resolution curves; It should be noted that the division method of the historical sub-resolution curves is the same as that of the historical column efficiency sub-curves, and the total number of the historical sub-resolution curves and the historical column efficiency sub-curves is the same and is odd; On the historical sub-resolution curve, arbitrarily extract two corresponding coordinates, and perform simulation fitting by the least square method to obtain a simulated separation fitting line; Extract the closed figure formed by the simulated separation fitting line and the corresponding historical sub-resolution curve, and obtain the sum of the areas of the closed figures for summation calculation to obtain the fitting separation matching degree; It can be understood that the meaning represented by the fitting separation matching degree is: the sum of the areas of all closed figures formed between the historical separation sub-curves and the simulated separation fitting line, which is a quantitative index used to evaluate the fitting degree of the simulated separation fitting line to the historical separation sub-curves. Specifically, the smaller the fitting separation matching degree, the smaller the difference between the simulated separation fitting line and the historical separation sub-curves, and the higher the fitting separation matching degree, the greater the difference between the simulated separation fitting line and the historical separation sub-curves, and the lower the fitting separation matching degree; If the fitting separation matching degree is greater than the standard fitting matching degree, it means that the difference between the simulated separation fitting line and the historical separation sub-curves is small, and the fitting separation matching degree is high. It is necessary to perform iterative simulation fitting operations on the simulated separation fitting line until the fitting separation matching degree is less than or equal to the standard fitting matching degree; If the fitting separation matching degree is less than or equal to the standard fitting matching degree, it means that the difference between the simulated separation fitting line and the historical separation sub-curves is large, and the fitting separation matching degree is low. The simulated fitting line is used as the separation reference line, and the slope of the historical separation sub-curve is calculated through the slope calculation formula; It should be noted that the slopes of multiple historical separation sub-curves are not zero; Based on the same historical detection period as the benchmark, the slopes of the corresponding historical separation sub-curves and the slopes of the historical column efficiency sub-curves are extracted respectively; The slopes of the historical separation sub-curves and the slopes of the historical column efficiency sub-curves corresponding to all historical detection periods are respectively input into the Lance distance formula according to the time series of the historical detection periods, and the column efficiency separation correlation degree is output ; Specifically, the Lance distance formula: , where represents the slope of the historical separation sub-curve in the th historical detection period, represents the slope of the historical column efficiency sub-curve in the th historical detection period, represents the total number of historical detection periods; It should be noted that the purpose of using the Lance distance formula is: the column efficiency separation correlation degree output by the Lance distance formula is a specific value, which provides a quantitative index for analyzing the relationship between the historical column efficiency value and the historical separation degree, and can intuitively judge the tightness of the relationship between the two according to the size of this index, which is convenient for comparison and evaluation; It can be understood that the meaning represented by the column efficiency separation correlation degree is as follows: The changes in the slopes of the historical separation sub-curves and the historical column efficiency sub-curves in all historical detection periods are comprehensively considered. Specifically, the slope of the historical separation sub-curve reflects the change trend of historical resolution over time, and the slope of the historical column efficiency sub-curve reflects the change trend of historical column efficiency value over time. Using the column efficiency separation correlation degree to quantify the similarity between the slopes of these two groups reflecting the change trends means that the column efficiency of the chromatographic column itself is of relatively high importance in the analysis and detection of polymyxin B sulfate, especially in terms of the accuracy of the content detection of polymyxin B sulfate, with a relatively high important weight ratio; If the column efficiency separation correlation degree is greater than the preset standard correlation degree, it indicates that the change trends of the historical column efficiency value and the historical resolution are quite different, the correlation degree is less tight, and a small signal of column efficiency influence is generated; If the column efficiency separation correlation degree is less than or equal to the preset standard correlation degree, it indicates that the change trends of the historical column efficiency value and the historical resolution are less different, the correlation degree is relatively tight, and a large signal of column efficiency influence is generated; This embodiment is specifically as follows: During the historical detection period, the historical resolution after each analysis and detection is obtained. The historical separation sub-line is obtained by dividing the constructed historical separation change curve, and iterative fitting analysis is performed. The fitting line with a high fitting matching degree is selected, and the corresponding slope is obtained as the slope of the historical separation sub-line, which helps to improve the characterization accuracy of the slope of the historical separation sub-line. Based on the same historical detection period as the benchmark, the corresponding slopes of the historical separation sub-curve and the historical column efficiency sub-curve are respectively extracted and the correlation degree is compared. If the correlation degree is large, it indicates that the column efficiency of the chromatographic column itself is of relatively high importance in the analysis and detection of polymyxin B sulfate, especially in terms of the accuracy of the content detection of polymyxin B sulfate. Therefore, the importance of the column efficiency of the chromatographic column itself is emphasized.

[0024] Embodiment 3

[0025] As Figure 1 shown, an analysis and detection method for polymyxin B sulfate according to an embodiment of the present invention further includes the following steps: Step Four: According to the identified type of change trend, obtain the predicted column life loss degree and the current column efficiency value of the current chromatographic column for the analysis and detection of polymyxin B sulfate, and perform combined analysis to obtain the predicted remaining column life value; In a preferred embodiment, if it is a type of fluctuating decline, the Y-axis coordinates of adjacent coordinate points on the historical column efficiency change curve are processed by taking the difference, and the adjacent decline difference is output. The maximum adjacent decline difference and the minimum adjacent decline difference are extracted for averaging calculation, and the predicted column life loss degree is output; If it is a stable decline type, the Y-axis coordinates of adjacent coordinate points on the historical column efficiency change curve are processed by taking the difference, and the adjacent decline differences are output; All adjacent decline differences are averaged to calculate and output the predicted column life loss degree; The current column efficiency value is divided by the predicted column life loss degree to obtain the predicted remaining column life value; Specifically in this embodiment: according to the identified change trend type, the predicted column life loss degree and the current column efficiency value of the current chromatographic column for analyzing and detecting polymyxin B sulfate are obtained. The current column efficiency value is divided by the predicted column life loss degree to obtain the predicted remaining column life value, which solves the problem that in the analysis and detection of polymyxin B sulfate, the service life of the chromatographic column cannot be accurately known. By predicting the service life of the chromatographic column, it helps the experimenters to understand the usage status of the chromatographic column in advance, replace the chromatographic column in time, ensure the accuracy and reliability of the analysis and detection results of polymyxin B sulfate, avoid affecting the detection accuracy due to the aging of the chromatographic column, and at the same time can reasonably arrange the experimental process and improve the experimental efficiency.

[0026] The above shows and describes the basic principles, main features and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited by the above embodiments. What is described in the above embodiments and the specification only illustrates the principles of the present invention. Without departing from the spirit and scope of the present invention, the present invention will have various changes and improvements, and these changes and improvements all fall within the scope of the present invention claimed. The scope of protection claimed by the present invention is defined by the appended claims and their equivalents.

Claims

1. An analytical detection method for polymyxin B sulfate, characterized in that: Including: During the historical detection period, record the historical column efficiency values of multiple chromatographic column analyses and detections of polymyxin B sulfate, and conduct trend change analysis to determine whether the column efficiency has decreased; If the column efficiency of the chromatographic column decreases, analyze the change trend type of the column efficiency value corresponding to the polymyxin B sulfate analysis and detection operation to determine the change trend type of the column efficiency; Among them, the change trend types include stable decline type or fluctuating decline type; During the historical detection period, obtain the historical resolution after each analysis and detection operation, analyze the correlation with the historical column efficiency value, and evaluate the influence degree of the column efficiency corresponding to the chromatographic column on the detection resolution; If the influence degree is large, according to the identified change trend type, obtain the predicted column life loss degree, and the current column efficiency value of the chromatographic column for polymyxin B sulfate analysis and detection, and conduct combined analysis to obtain the predicted remaining column life value.

2. The analytical detection method of polymyxin B sulfate according to claim 1, characterized in that: The method for obtaining the historical column efficiency value is: Respectively obtain the half-peak width and retention time on the liquid chromatograph corresponding to the chromatographic column analysis and detection operation, and input them into the theoretical plate number calculation formula to output the historical column efficiency value.

3. The analytical detection method of polymyxin B sulfate according to claim 1, wherein: The process of trend change analysis for the historical column efficiency values of multiple chromatographic column analysis and detection operations is as follows: Evenly divide the historical detection period into several historical detection time periods; Extract the historical column efficiency values within each detection time period, and construct a historical column efficiency change curve according to the time series of the corresponding time periods, and divide it into several historical column efficiency sub-curves; On the historical column efficiency sub-curve, randomly extract two corresponding coordinates, and perform simulation fitting by the least squares method to obtain a simulated column efficiency fitting line, and obtain the area of the closed figure formed by the corresponding historical column efficiency sub-curve, and perform summation calculation to obtain the fitting column efficiency matching degree. If it is less than or equal to the standard fitting matching degree, use the simulated fitting line as the column efficiency reference line, and calculate the slope of the historical column efficiency sub-curve through the slope calculation formula.

4. The analytical detection method of polymyxin B sulfate according to claim 3, characterized in that: The process of determining whether the column efficiency has decreased is as follows: Count the number of historical column efficiency sub-fitting lines with a negative slope of the historical column efficiency sub-curve and the number of historical column efficiency sub-fitting lines with a positive slope of the historical column efficiency sub-curve; If the number of historical column efficiency sub-fitting lines with a negative slope of the sub-fitting line is greater than the number of historical column efficiency sub-fitting lines with a positive slope of the sub-fitting line, generate a column efficiency decrease signal.

5. The analytical detection method of polymyxin B sulfate according to claim 3, wherein: The process of identifying the change trend type is as follows: Combine the slopes of adjacent historical column efficiency sub-curves to obtain multiple sub-curve slope groups, and process the slopes of the historical column efficiency sub-curves within multiple sub-curve slope groups through the Mahalanobis distance formula to obtain the trend type identification value; If the trend type identification value is greater than the trend type identification threshold, it is the fluctuating decline type; If the trend type identification value is less than or equal to the trend type identification threshold, it is the stable decline type.

6. The analytical detection method of polymyxin B sulfate according to claim 1, characterized in that: The process of obtaining the historical resolution is as follows: Within any historical detection time period, obtain the content of polymyxin B sulfate after extraction, and calculate the ratio with the content of the extraction solution before extraction to obtain the historical resolution.

7. The analytical and detection method of polymyxin B sulfate according to claim 6, wherein: The process of analyzing the correlation between the detection resolution and the historical column efficiency value is as follows: Respectively extract the historical resolution and historical column efficiency values within all historical detection time periods; Based on the historical separation degrees within all historical detection periods, construct a historical separation change curve and divide it into several historical sub-separation curves; On the historical sub-separation curve, arbitrarily extract two corresponding coordinates and perform simulation fitting by the least squares method to obtain a simulated separation fitting line. Then sum up the areas of all closed figures formed by the historical sub-separation curves to obtain the fitting separation matching degree. If it is less than or equal to the standard fitting matching degree, take the simulated fitting line as the separation reference line and calculate the slope of the historical sub-separation curve through the slope calculation formula; Based on the same historical detection period as the benchmark, respectively extract the slopes of the corresponding historical sub-separation curves and historical column efficiency sub-curves, and process the slopes of the historical sub-separation curves and historical column efficiency sub-curves corresponding to all historical detection periods according to the historical detection period by the Lance distance formula, and output the column efficiency separation correlation degree.

8. The analytical detection method of polymyxin B sulfate according to claim 5, characterized in that: Evaluate the influence degree of the column efficiency value corresponding to the chromatographic column on the detection separation degree. The process is as follows: If the column efficiency separation correlation degree is greater than the preset standard correlation degree, generate a small signal of low column efficiency influence; If the column efficiency separation correlation degree is less than or equal to the preset standard correlation degree, generate a large signal of high column efficiency influence.

9. The analytical detection method of polymyxin B sulfate according to claim 1, characterized in that: The process of obtaining the measured column life loss degree is as follows: If it is of the fluctuating decline type, perform difference processing on the Y-axis coordinates of adjacent coordinate points on the historical column efficiency change curve, output the adjacent decline difference, extract the maximum adjacent decline difference and the minimum adjacent decline difference for averaging calculation, and output the predicted column life loss degree; If it is of the stable decline type, perform difference processing on the Y-axis coordinates of adjacent coordinate points on the historical column efficiency change curve, and output the adjacent decline difference; Perform averaging calculation on all adjacent decline differences and output the predicted column life loss degree.

10. The analytical detection method of polymyxin B sulfate according to claim 9, characterized in that: The process of obtaining the predicted remaining column life value is as follows: Calculate the ratio of the current column efficiency value to the predicted column life loss degree to obtain the predicted remaining column life value.

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