A method for identifying a drug preparation for treating respiratory diseases

Abstract

The present invention relates to the technical field of analyzing drug components by optical means, and specifically to a method for identifying a drug preparation for treating respiratory diseases. The present invention uses the spectral absorption peak of a single component as a standard reference, analyzes the aliasing effect of a drug spectral curve, and then combines the characteristics of the difference in absorbance change after the absorption peak is affected by aliasing to accurately obtain the adjustment wavelength range of each absorption peak, thereby avoiding the aliasing interference of the absorption peak of a high-content component on the absorption peak of a low-content component when performing qualitative and quantitative analysis on the drug spectral curve by traditional methods, thereby improving the accuracy of qualitative and quantitative analysis of the drug spectral curve, and also improving the accuracy of identifying drug preparations for treating respiratory diseases.

Description

Technical Field

[0001] The invention relates to the technical field of analyzing drug components by optical means, and in particular to a method for identifying drug preparations for treating respiratory diseases. Background Art

[0002] Drugs for treating respiratory diseases can be used to help patients improve or relieve symptoms of dyspnea. However, the premise for achieving the expected therapeutic effect is that the drugs for treating respiratory diseases must not contain impurities and the active ingredients must reach a certain concentration or content. Therefore, it is very important to analyze and identify the components of drugs for treating respiratory diseases. Spectroscopic analysis is a non-destructive analysis technology widely used in the field of drug analysis. It can perform qualitative and quantitative analysis on the components in drug samples, thereby ensuring the quality and safety of drugs.

[0003] However, in the process of using spectral analysis technology to obtain drug spectral data for component content analysis, due to the differences in the contents of various drug components, the characteristic signals of low-content components in the drug spectrum may often be submerged by the characteristic signals of other high-content components, resulting in band aliasing. As a result, when estimating the content of each component based on the drug spectral data, the content of each component cannot be accurately determined, which in turn affects the accuracy of identification of drug preparations for the treatment of respiratory diseases. Summary of the invention

[0004] In order to solve the technical problem that the prior art has poor accuracy in identifying pharmaceutical preparations for treating respiratory diseases, the object of the present invention is to provide a method for identifying pharmaceutical preparations for treating respiratory diseases. The technical scheme adopted is as follows:

[0005] Obtaining a drug spectrum curve of a respiratory disease drug preparation and a standard absorption peak of each known component in the respiratory disease drug preparation;

[0006] According to the standard absorption peaks of all known components and the absorption peak characteristics of the drug spectrum curve, the target absorption peak of each known component in the drug spectrum curve is obtained; according to the offset of the target absorption peaks of all known components relative to the standard absorption peak, the aliasing influence coefficient of each known component corresponding to the target absorption peak in the drug spectrum curve is obtained;

[0007] All absorption peaks to be adjusted are screened out from all the target absorption peaks according to the aliasing influence coefficient; according to the change of the absorbance of each absorption peak to be adjusted on both sides of each wavelength value, the boundary confidence index of each wavelength in the absorption peak to be adjusted as the adjustment wavelength interval is obtained; according to the boundary confidence index of each wavelength in each absorption peak to be adjusted as the adjustment wavelength interval, the adjustment wavelength interval of each absorption peak to be adjusted is obtained;

[0008] According to the adjustment wavelength range of each absorption peak to be adjusted and the corresponding wavelength range of each absorption peak not to be adjusted, the drug spectrum curve is spectrally analyzed to obtain all components and corresponding contents in the respiratory disease drug preparation.

[0009] Furthermore, the method for obtaining the standard absorption peak includes:

[0010] Obtain a reference standard spectral curve for each known component in a respiratory disease pharmaceutical preparation; and use the absorption peak with the largest peak value in each of the reference standard spectral curves as the standard absorption peak of the corresponding known component.

[0011] Furthermore, the target absorption peak acquisition method includes:

[0012] Taking any known component as the component to be analyzed, taking the peak value corresponding wavelength of the standard absorption peak of the component to be analyzed as the standard characteristic wavelength; taking the peak value corresponding wavelength of each absorption peak in the drug spectrum curve as the characteristic wavelength of the corresponding absorption peak;

[0013] Among the characteristic wavelengths of all absorption peaks in the drug spectral curve, the characteristic wavelength with the smallest difference from the standard characteristic wavelength of the component to be analyzed is used as the target characteristic wavelength of the component to be analyzed in the drug spectral curve, and the absorption peak corresponding to the target characteristic wavelength is used as the target absorption peak of the component to be analyzed in the drug spectral curve.

[0014] Furthermore, the method for obtaining the aliasing influence coefficient includes:

[0015] Taking any known component as the component to be analyzed; obtaining a direct aliasing influence parameter of the component to be analyzed according to a peak difference between the peak value of the standard absorption peak of the component to be analyzed and the peak value of the target absorption peak;

[0016] Obtaining the absorption peak characteristic parameters of each non-to-be-analyzed component according to the peak difference between the peak value of the standard absorption peak of each non-to-be-analyzed component and the peak value of the target absorption peak; obtaining the indirect aliasing influence parameters of the component to be analyzed by combining the absorption peak characteristic parameters of all non-to-be-analyzed components;

[0017] According to the direct aliasing influence parameter and the indirect aliasing influence parameter of each known component, the aliasing influence coefficient of the target absorption peak corresponding to each known component in the drug spectrum curve is obtained.

[0018] Furthermore, the method for obtaining the direct aliasing impact parameter includes:

[0019] The ratio between the peak value of the standard absorption peak of the component to be analyzed and the peak value of the target absorption peak is used as the characteristic deviation parameter of the component to be analyzed; the difference between the constant 1 and the characteristic deviation parameter is used as the direct aliasing influence parameter of the component to be analyzed.

[0020] Furthermore, the method for obtaining the indirect aliasing impact parameter includes:

[0021] The ratio between the peak value of the standard absorption peak of each non-to-be-analyzed component and the peak value of the target absorption peak is used as the absorption peak characteristic parameter of each non-to-be-analyzed component; the absorption peak characteristic parameters of all non-to-be-analyzed components are averaged and then negatively correlated normalized, and the negative correlation normalization result is used as the indirect aliasing influence parameter of the component to be analyzed.

[0022] Furthermore, the method for obtaining the absorption peak to be adjusted includes:

[0023] The target absorption peak whose aliasing influence coefficient is greater than or equal to a preset threshold is used as the absorption peak to be adjusted.

[0024] Furthermore, the method for obtaining the boundary confidence index includes:

[0025] Any wavelength in the wavelength range corresponding to each absorption peak to be adjusted is used as the wavelength to be analyzed; in the drug spectrum curve, a preset wavelength range is constructed with the wavelength to be analyzed as the center; in the preset wavelength range, the absorption peak to be adjusted is divided into a first absorption peak sub-segment and a second absorption peak sub-segment with the wavelength to be analyzed as the dividing point;

[0026] In the drug spectrum curve, the difference in absorbance between the wavelength to be analyzed and the adjacent previous wavelength, and the sum of the difference in absorbance between the wavelength to be analyzed and the adjacent subsequent wavelength are used as the first boundary confidence index;

[0027] Obtaining a second boundary confidence index according to a difference in absorbance changes between the first absorption peak subsegment and the second absorption peak subsegment; the difference in absorbance change is positively correlated with the second boundary confidence index;

[0028] The boundary confidence index of each wavelength in the absorption peak to be adjusted as the adjustment wavelength interval is obtained according to the first boundary confidence index and the second boundary confidence index.

[0029] Furthermore, the method for obtaining the second boundary confidence index includes:

[0030] The overall slope of the first absorption peak subsegment is taken as a first variation parameter, and the overall slope of the second absorption peak subsegment is taken as a second variation parameter; the difference between the first variation parameter and the second variation parameter is taken as a second boundary confidence index.

[0031] Furthermore, the method for obtaining the adjusted wavelength range includes:

[0032] In each wavelength interval corresponding to the absorption peak to be adjusted, a first wavelength interval and a second wavelength interval are obtained by taking the corresponding target characteristic wavelength as a dividing point; the wavelength corresponding to the maximum boundary confidence index in the first wavelength interval is taken as the left endpoint of the adjustment wavelength interval of the absorption peak to be adjusted, and the wavelength corresponding to the maximum boundary confidence index in the second wavelength interval is taken as the right endpoint of the adjustment wavelength interval of the absorption peak to be adjusted; and the corresponding adjustment wavelength interval is determined using the left endpoint and the right endpoint.

[0033] The present invention has the following beneficial effects:

[0034] The present invention obtains a drug spectrum curve of a respiratory disease drug preparation and a standard absorption peak of each known component in the respiratory disease drug preparation, providing a standard reference for subsequent analysis and evaluation; obtains a target absorption peak of each known component in the drug spectrum curve according to the standard absorption peaks of all known components and the absorption peak characteristics of the drug spectrum curve; obtains an aliasing influence coefficient of the target absorption peak corresponding to each known component in the drug spectrum curve according to the offset of the target absorption peaks of all known components relative to the standard absorption peak; the aliasing influence coefficient is based on the offset of the absorption peak relative to the standard reference, and evaluates the degree of aliasing influence of other components in the drug spectrum curve corresponding to each known component in a mixed state, thereby facilitating the subsequent screening of the components affected by aliasing. The higher absorption peak to be adjusted is used for correction and adjustment, so as to accurately perform quantitative analysis on each component and improve the accuracy of preparation identification; further, according to the change in the absorbance rate of each absorption peak to be adjusted on both sides of each wavelength value, the boundary confidence index of each wavelength in the absorption peak to be adjusted as the adjustment wavelength range is obtained, and the boundary confidence index reflects the possibility that each wavelength corresponds to the wavelength corresponding to the aliasing critical change point, so as to facilitate the subsequent screening of the aliasing critical change point, so as to determine the adjustment wavelength range of each absorption peak to be adjusted; according to the adjustment wavelength range of each absorption peak to be adjusted, and the corresponding wavelength range of each non-absorption peak to be adjusted, the drug spectrum curve is spectrally analyzed to obtain all components and corresponding contents in the respiratory disease drug preparation. The present invention uses the spectral absorption peak of a single component as a standard reference, analyzes the aliasing effect of the drug spectral curve of the respiratory disease drug preparation to be identified, and then accurately obtains the adjustment wavelength range of each absorption peak in combination with the characteristics of the difference in absorbance change after the absorption peak is affected by aliasing, thereby avoiding the aliasing interference of the absorption peak of a high-content component on the absorption peak of a low-content component when performing qualitative and quantitative analysis on the drug spectral curve by traditional methods, thereby improving the accuracy of qualitative and quantitative analysis of the drug spectral curve, and also improving the accuracy of identification of drug preparations for treating respiratory diseases. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the technical solutions and advantages in the embodiments of the present invention or the prior art, the drawings required for use in the embodiments or the prior art descriptions are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0036] Figure 1 A flowchart of a method for identifying a pharmaceutical preparation for treating respiratory diseases provided by one embodiment of the present invention;

[0037] Figure 2 A flow chart of a method for obtaining an aliasing influence coefficient provided by an embodiment of the present invention;

[0038] Figure 3 A flow chart of a method for obtaining a boundary confidence index provided by an embodiment of the present invention. DETAILED DESCRIPTION

[0039] In order to further explain the technical means and effects adopted by the present invention to achieve the predetermined invention purpose, the following is a detailed description of the specific implementation method, structure, characteristics and effects of a method for identifying a pharmaceutical preparation for treating respiratory diseases proposed by the present invention in combination with the accompanying drawings and preferred embodiments. In the following description, different "one embodiment" or "another embodiment" does not necessarily refer to the same embodiment. In addition, specific features, structures or characteristics in one or more embodiments may be combined in any suitable form.

[0040] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.

[0041] The specific scheme of the method for identifying a pharmaceutical preparation for treating respiratory diseases provided by the present invention is described in detail below with reference to the accompanying drawings.

[0042] See also Figure 1 , which shows a flow chart of a method for identifying a pharmaceutical preparation for treating respiratory diseases provided by an embodiment of the present invention, specifically comprising:

[0043] Step S1, obtaining a drug spectrum curve of a respiratory disease drug preparation and a standard absorption peak of each known component in the respiratory disease drug preparation.

[0044] In one embodiment of the present invention, in order to identify a pharmaceutical preparation for treating respiratory diseases, a near-infrared spectrometer is first used to obtain a near-infrared spectrum curve of the respiratory disease pharmaceutical preparation to be identified, and the near-infrared spectrum curve is used as the pharmaceutical spectrum curve to facilitate subsequent analysis of the characteristics of each absorption peak and evaluation of the corresponding components; at the same time, in order to facilitate subsequent analysis and evaluation of the aliasing effect between the corresponding absorption peaks of different components in the respiratory disease pharmaceutical preparation, and then accurately evaluate the component content, this embodiment will further obtain the standard absorption peak of each known component in the respiratory disease pharmaceutical preparation based on the ingredient list and other relevant pharmaceutical information, to provide a reference for subsequent analysis and evaluation.

[0045] Among them, in a preferred embodiment of the present invention, taking into account that different components in the drug have different absorption characteristics in the corresponding infrared spectrum due to their different molecular structures, and each known component may correspond to more than one absorption peak, and the absorption peak with the highest peak value often represents the main component, which can be regarded as the main absorption peak of the component; therefore, the method for obtaining the standard absorption peak includes: obtaining the near-infrared spectrum curve of each known component in the respiratory disease drug preparation, and using it as the reference standard spectrum curve corresponding to each known component; taking the peak value of the absorption peak with the largest peak value in each reference standard spectrum curve as the standard absorption peak corresponding to the known component.

[0046] It should be noted that each known ingredient is determined by the ingredient list of respiratory disease drug preparations and other relevant pharmaceutical information, which contains relevant information such as the concentration and content of each ingredient; when using a near-infrared spectrometer to obtain the near-infrared spectral curve of each known ingredient, it is necessary to ensure the consistency of experimental conditions, such as ensuring that each known ingredient is consistent with the concentration, content and test environment of the known ingredient in the respiratory disease drug preparation, so as to ensure the reference validity; the corresponding reference standard spectral curve can also be obtained through a known spectral database or relevant literature; implementers can also select some major known ingredients, such as selecting the top 80% of the known ingredients in content ranking for analysis, and obtain the corresponding standard absorption peaks for subsequent reference.

[0047] It should be noted that obtaining a near-infrared spectral curve and all absorption peaks in the near-infrared spectral curve is an existing technology well known to those skilled in the art and will not be elaborated here; implementers may also use other spectrometers to perform spectral analysis on the respiratory disease drug preparation to be identified according to actual conditions, which will not be elaborated here.

[0048] Step S2, according to the standard absorption peaks of all known components and the absorption peak characteristics of the drug spectrum curve, obtain the target absorption peak of each known component in the drug spectrum curve; according to the offset of the target absorption peaks of all known components relative to the standard absorption peak, obtain the aliasing influence coefficient of the target absorption peak corresponding to each known component in the drug spectrum curve.

[0049] Taking into account that components of different concentrations will result in different intensities of absorption peaks, components with higher concentrations will produce stronger absorption peaks, while components with lower concentrations will produce weaker absorption peaks; when performing quantitative analysis on drug spectral curves, due to the mixing of multiple components in respiratory disease drug preparations, high-concentration components will affect the performance of low-concentration components in the drug spectral curve, resulting in a certain aliasing effect, which is not conducive to accurate quantitative analysis of low-concentration components; and considering that the corresponding band of each component in the near-infrared spectrum is usually standard and fixed, the absorption peak can be matched according to the corresponding wavelength of the standard absorption peak of the known component.

[0050] Therefore, after obtaining the standard absorption peaks of all known components, the embodiment of the present invention first obtains the target absorption peak of each known component in the drug spectral curve based on the standard absorption peak and the absorption peak characteristics in the drug spectral curve; wherein the target absorption peak is the suspected main characteristic peak corresponding to each known component in the drug spectral curve, so as to facilitate the subsequent evaluation of the aliasing effect of the suspected main characteristic peak corresponding to each known component in combination with the offset of the target absorption peak of each known component relative to the standard absorption peak.

[0051] Preferably, in one embodiment of the present invention, considering that the mutual influence between different drug components may cause a certain offset in the drug spectrum curve of the corresponding wavelength of the main absorption peak of each known component, the nearest screening and matching can be performed; based on this, the method for obtaining the target absorption peak includes:

[0052] Taking any known component as the component to be analyzed, taking the peak value corresponding wavelength of the standard absorption peak of the component to be analyzed as the standard characteristic wavelength; taking the peak value corresponding wavelength of each absorption peak in the drug spectrum curve as the characteristic wavelength of the corresponding absorption peak;

[0053] Among the characteristic wavelengths of all absorption peaks in the drug spectral curve, the characteristic wavelength with the smallest difference from the standard characteristic wavelength of the component to be analyzed is used as the target characteristic wavelength of the component to be analyzed in the drug spectral curve, and the absorption peak corresponding to the target characteristic wavelength is used as the target absorption peak of the component to be analyzed in the drug spectral curve.

[0054] As an example, take any known component as the component to be analyzed, obtain the absolute value of the wavelength difference between the standard characteristic wavelength of the component to be analyzed and each characteristic wavelength, and take the characteristic wavelength corresponding to the minimum absolute value of the wavelength difference as the target characteristic wavelength in the drug spectrum curve of the component to be analyzed, and then obtain the target absorption peak of the component to be analyzed in the drug spectrum curve; change the component to be analyzed, and obtain the target absorption peak and target characteristic wavelength of each known component in the drug spectrum curve.

[0055] Considering that the absorption peak characteristics of each known component in the near-infrared spectrum are usually fixed by standards, if the absorption peak of a certain component is significantly shifted or deformed in the drug spectrum curve, it can be considered that it is interfered or affected by other components; and the greater the degree of shift or deformation, the more serious the aliasing effect of the component in the drug spectrum curve;

[0056] Therefore, the embodiment of the present invention will obtain the aliasing influence coefficient of the target absorption peak corresponding to each known component in the drug spectrum curve according to the offset of the target absorption peak of all known components relative to the standard absorption peak. The aliasing influence coefficient is based on the absorption peak offset characteristics of each known component under different experimental conditions, that is, the offset of the absorption peak relative to the standard reference, and evaluates the degree of aliasing influence of other components on each known component in the drug spectrum curve corresponding to the mixed state, thereby facilitating the subsequent screening of absorption peaks that are more affected by aliasing for correction and adjustment, thereby accurately performing quantitative analysis on each component and improving the accuracy of preparation identification.

[0057] Preferably, in one embodiment of the present invention, the method for obtaining the aliasing influence coefficient includes:

[0058] See also Figure 2 , which shows a flow chart of a method for obtaining an aliasing influence coefficient provided by an embodiment of the present invention, specifically comprising:

[0059] Step S201, taking any known component as the component to be analyzed; obtaining the direct aliasing influence parameter of the component to be analyzed according to the peak difference between the peak value of the standard absorption peak of the component to be analyzed and the peak value of the target absorption peak.

[0060] Taking into account the peak difference between the peak value of the standard absorption peak of each known component and the peak value of the target absorption peak, the aliasing effect on the known components can be directly reflected. Based on this, any known component is taken as the component to be analyzed, and the direct aliasing effect parameter of the component to be analyzed is obtained; the direct aliasing effect parameter directly reflects the degree of aliasing effect on the component to be analyzed in the drug spectral curve from the perspective of the component to be analyzed itself. The larger the peak difference, the more likely it is that the absorption rate of other components is superimposed, and the larger the direct aliasing effect parameter.

[0061] In a preferred embodiment of the present invention, considering that each absorption peak in the drug spectrum curve is affected by aliasing, its absorbance usually presents a superposition increase, then the peak value of the target absorption peak of the component to be analyzed is relatively increased relative to the peak value of the standard absorption peak after being affected by the aliasing of other components; therefore, the method for obtaining the aliasing influence parameter includes:

[0062] The ratio between the peak value of the standard absorption peak of the component to be analyzed and the peak value of the target absorption peak is used as the characteristic deviation parameter of the component to be analyzed; the difference between the constant 1 and the characteristic deviation parameter is used as the direct aliasing influence parameter of the component to be analyzed.

[0063] As an example, the direct aliasing contribution parameter is calculated as: ;in, is the serial number of the component to be analyzed; is the direct aliasing influence parameter of the mth component to be analyzed; is the peak value of the standard characteristic peak of the mth component to be analyzed; is the peak value of the target characteristic peak of the mth component to be analyzed.

[0064] In this example, the peak difference is measured by the difference between the ratio and the constant 1. The smaller the ratio, the higher the peak value of the target absorption peak is than the peak value of the standard absorption peak, the greater the degree of deviation is, and the greater the direct aliasing impact parameter is. In other examples, the implementer can also directly linearly normalize the difference between the peak value of the target absorption peak and the peak value of the standard absorption peak to obtain the direct aliasing impact parameter. The implementer can also use other normalization methods or other difference measurement methods, which are not repeated here.

[0065] Step S202, obtaining the absorption peak characteristic parameters of each non-to-be-analyzed component according to the peak difference between the peak value of the standard absorption peak of each non-to-be-analyzed component and the peak value of the target absorption peak; and obtaining the indirect aliasing influence parameters of the component to be analyzed by combining the absorption peak characteristic parameters of all non-to-be-analyzed components.

[0066] Considering that the aliasing effect of each component to be analyzed is mainly affected by the interference of other known components, the aliasing offset of other known components will also have a certain aliasing effect on the component to be analyzed; therefore, when analyzing the aliasing effect of each component to be analyzed, it is necessary not only to analyze the direct aliasing effect parameters of each component to be analyzed, but also to analyze the absorption peak offset of other known components except the component to be analyzed, that is, to analyze the peak difference between the peak value of the standard absorption peak of other known components and the peak value of the target absorption peak, so as to provide a certain reference for evaluating the aliasing effect of the component to be analyzed;

[0067] Based on this, firstly, all the remaining known components except the component to be analyzed are regarded as non-components to be analyzed, and the absorption peak characteristic parameters of each non-component to be analyzed are obtained, and then the absorption peak characteristic parameters of all non-components to be analyzed are comprehensively evaluated to evaluate their indirect aliasing influence parameters on the component to be analyzed; the indirect aliasing influence parameters indirectly reflect the degree of aliasing influence on the drug spectral curve from the perspective of the remaining non-components to be analyzed. The more serious the aliasing offset of the remaining non-components to be analyzed, the greater the indirect aliasing influence on the component to be analyzed, and the greater the indirect aliasing influence parameters.

[0068] In a preferred embodiment of the present invention, a method for obtaining an indirect aliasing influence parameter includes:

[0069] The ratio between the peak value of the standard absorption peak of each non-to-be-analyzed component and the peak value of the target absorption peak is used as the absorption peak characteristic parameter of each non-to-be-analyzed component; the absorption peak characteristic parameters of all non-to-be-analyzed components are averaged and then negatively correlated normalized, and the negative correlation normalization result is used as the indirect aliasing influence parameter of the component to be analyzed.

[0070] As an example, the indirect aliasing contribution parameter is calculated as: ;in, is the serial number of the component to be analyzed; is the serial number of the component not to be analyzed; is the total number of known ingredients; is the indirect aliasing influence parameter of the mth component to be analyzed; is the standard normalization function; For the The peak value of the standard characteristic peak of the non-component to be analyzed; For the The peak value of the target characteristic peak of the non-component to be analyzed; For the Characteristic parameters of the absorption peaks of non-analyzed components.

[0071] In this example, a ratio is specifically used to measure the characteristic parameter of each absorption peak not to be analyzed. The smaller the ratio, the higher the peak value of the target absorption peak is than the peak value of the standard absorption peak, the greater the degree of deviation is, and the smaller the characteristic parameter of the absorption peak is. Then, the average is calculated and linear normalization is performed, and the difference between the constant 1 and the normalized value is used to measure the deviation of the absorption peaks of all non-analyzed components. The larger the difference is, the greater the indirect aliasing influences the parameter. In other examples, the implementer may directly use the difference between the peak value of the target absorption peak and the peak value of the standard absorption peak as the characteristic parameter of the absorption peak, or may use other normalization methods or other difference measurement methods, which are not described here.

[0072] Step S203, obtaining the aliasing influence coefficient of the target absorption peak corresponding to each known component in the drug spectrum curve according to the direct aliasing influence parameter and the indirect aliasing influence parameter of each known component.

[0073] As an example, by changing the component to be analyzed, the direct aliasing influence parameter of each known component can be obtained; then the direct aliasing influence parameter and the indirect aliasing influence parameter of each known component are multiplied and combined, and then linearly normalized to obtain the aliasing influence coefficient of the target absorption peak corresponding to each known component in the drug spectrum curve; in other examples, the implementer can also use other basic mathematical operations such as addition or weighted merging or related mapping methods to merge the two, which will not be repeated here.

[0074] In another embodiment of the present invention, considering that the shift of the peak value corresponding to the wavelength of the absorption peak also indirectly reflects that it is affected by aliasing, the same calculation idea in steps S201-S203 can also be used to evaluate the wavelength difference between the peak value corresponding to the wavelength of the target characteristic peak and the peak value corresponding to the wavelength of the standard characteristic peak, evaluate the shift of the absorption peak, obtain the second aliasing influence coefficient of each known component, and then combine the aliasing influence coefficient obtained in steps S201-S203 with the second aliasing influence coefficient to evaluate the aliasing influence of each known component, such as adding, multiplying or weighted summing the aliasing influence coefficient obtained in steps S201-S203 and the second aliasing influence coefficient, and use the combined result as the final aliasing influence coefficient; the implementer can also evaluate its shift in combination with the shape change or area change of the absorption peak, which are measurement methods well known to those skilled in the art and will not be repeated here.

[0075] Step S3, screen out all absorption peaks to be adjusted from all target absorption peaks according to the aliasing influence coefficient; obtain the boundary confidence index of the adjustment wavelength interval for each wavelength in the absorption peak to be adjusted according to the change in the absorbance rate of each absorption peak to be adjusted on both sides of each wavelength value; obtain the adjustment wavelength interval of each absorption peak to be adjusted according to the boundary confidence index of the adjustment wavelength interval for each wavelength in each absorption peak to be adjusted.

[0076] The larger the aliasing influence coefficient is, the lower the accuracy will be in the subsequent quantitative analysis. Therefore, the embodiment of the present invention will screen out all absorption peaks to be adjusted from all target absorption peaks according to the aliasing influence coefficient of the target absorption peak corresponding to each known component in the drug spectrum curve; and then correct and adjust the absorption peaks to be adjusted to improve the accuracy of quantitative analysis.

[0077] Preferably, in one embodiment of the present invention, the method for obtaining the absorption peak to be adjusted includes: taking the target absorption peak whose aliasing influence coefficient is greater than or equal to a preset threshold as the absorption peak to be adjusted; wherein the preset threshold is 0.6, which can also be set by the implementer.

[0078] Considering that each absorption peak to be adjusted may include other components in its corresponding wavelength range due to the influence of aliasing, in order to improve the accuracy of subsequent quantitative analysis, it is necessary to adjust and confirm the initial wavelength range corresponding to the absorption peak to be adjusted; considering that the changes of the absorption peaks corresponding to different components may be different, when the absorption peak is interfered by the aliasing of other absorption peaks, the change of the absorbance in the corresponding wavelength range will show a certain critical change at the aliasing point; that is, if two absorption peaks are aliased, the change of the absorbance on the left side of the critical point is mainly affected by the change of the absorbance of one of the absorption peaks, and the absorbance on the right side of the critical point is mainly affected by the change of the absorbance of the other absorption peak, then there is a difference in the change of the absorbance on the left and right sides of the critical point;

[0079] Therefore, the embodiment of the present invention will obtain the boundary confidence index of each wavelength in the absorption peak to be adjusted as the adjustment wavelength range according to the change in the absorbance rate of each absorption peak to be adjusted on both sides of each wavelength value; the boundary confidence index reflects the possibility that each wavelength corresponds to the wavelength corresponding to the aliasing critical change point, so as to facilitate the subsequent screening of the aliasing critical change point, thereby determining the adjustment wavelength range of each absorption peak to be adjusted.

[0080] Preferably, in one embodiment of the present invention, the method for obtaining the boundary confidence index includes:

[0081] See also Figure 3 , which shows a flow chart of a method for obtaining a boundary confidence index provided by an embodiment of the present invention, specifically comprising:

[0082] Step S301, taking any wavelength in the wavelength range corresponding to each absorption peak to be adjusted as the wavelength to be analyzed; in the drug spectrum curve, constructing a preset wavelength range with the wavelength to be analyzed as the center; in the preset wavelength range, taking the wavelength to be analyzed as the dividing point, dividing the absorption peak to be adjusted into a first absorption peak sub-segment and a second absorption peak sub-segment.

[0083] In order to facilitate the description of the method for obtaining the boundary confidence index of each wavelength in each absorption peak to be adjusted as the adjustment wavelength interval, an embodiment of the present invention first describes and explains any wavelength in the wavelength interval corresponding to each absorption peak to be adjusted as the wavelength to be analyzed, and then changes the wavelength to be analyzed to obtain the boundary confidence index of each wavelength as the adjustment wavelength interval; then, in the drug spectrum curve, a preset wavelength interval is constructed with the wavelength to be analyzed as the center, wherein the length of the preset wavelength interval is 2n+1, that is, with the wavelength to be analyzed as the center, n wavelengths are obtained on the left and right sides to construct the preset wavelength interval, wherein n is 100, and the implementer can also set it according to the actual situation;

[0084] Then, in the preset wavelength range, the wavelength to be analyzed is used as the dividing point to obtain the first wavelength range and the second wavelength range, and then the absorption peak sub-segment corresponding to the absorption peak to be adjusted in the first wavelength range is used as the first absorption peak sub-segment. Similarly, the second absorption peak sub-segment can be obtained, so as to subsequently analyze the difference in changes between the first absorption peak sub-segment and the second absorption peak sub-segment, and determine that the wavelength to be analyzed is the boundary confidence index of the adjustment wavelength range.

[0085] Step S302: In the drug spectrum curve, the sum of the absorbance difference between the wavelength to be analyzed and the adjacent previous wavelength and the absorbance difference between the wavelength to be analyzed and the adjacent next wavelength is used as the first boundary confidence index.

[0086] Considering that even if the wavelength to be analyzed is the wavelength corresponding to the aliasing junction point, the difference between its corresponding absorbance and the adjacent wavelengths on both sides should be small, and there will be no large mutation; if there is a large mutation, it means that it may be at the top of the absorption peak, and the possibility of it being an aliasing junction point is low; therefore, in one embodiment of the present invention, the absolute value of the difference between the corresponding absorbance between the wavelength to be analyzed and the adjacent previous wavelength is first calculated, and then the absolute value of the difference between the corresponding absorbance between the wavelength to be analyzed and the adjacent next wavelength is calculated, and the sum of the two absolute values ​​of the difference is used as the first boundary confidence index.

[0087] Step S303, obtaining a second boundary confidence index according to a change difference between the first absorption peak sub-segment and the second absorption peak sub-segment; the change difference is positively correlated with the second boundary confidence index.

[0088] Considering that when an absorption peak is interfered by the aliasing of other absorption peaks, the change in the absorbance in the corresponding wavelength range will show a certain critical change at the aliasing point; if the wavelength to be analyzed is the wavelength corresponding to the aliasing boundary point, there will be a large difference in change between the first absorption peak sub-segment and the second absorption peak sub-segment on its left and right sides, which will lead to a larger second boundary confidence index.

[0089] In a preferred embodiment of the present invention, a method for obtaining the second boundary confidence index includes: taking the overall slope of the first absorption peak sub-segment as the first variation parameter, and taking the overall slope of the second absorption peak sub-segment as the second variation parameter; and taking the difference between the first variation parameter and the second variation parameter as the second boundary confidence index.

[0090] Among them, the method for obtaining the overall slope is based on the two-point slope calculation formula, calculating the corresponding slope between the first and last points of the absorption peak sub-segment, thereby obtaining the first change parameter and the second change parameter, and then taking the absolute value of the difference between the first change parameter and the second change parameter as the second boundary confidence index; the two-point slope calculation formula is a prior art and will not be repeated here.

[0091] In another embodiment of the present invention, the implementer also obtains a first absorption rate sequence corresponding to the first absorption peak sub-segment and a second absorption rate sequence corresponding to the second absorption peak sub-segment, respectively, wherein the sequence elements in the absorption rate sequence are the absorption rates at each wavelength in the corresponding wavelength range; then the first absorption rate sequence and the second absorption rate sequence are subjected to DTW analysis to obtain the DTW distance, the larger the DTW distance, the greater the difference between the absorption rate sequences, and the greater the difference in change between the first absorption peak sub-segment and the second absorption peak sub-segment, and the DTW distance is used as the second boundary confidence index.

[0092] In other embodiments, the implementer may also use other difference measurement methods to analyze and evaluate the change difference between the first absorption peak sub-segment and the second absorption peak sub-segment. The difference, slope difference and DTW distance are all difference measurement methods commonly used by technicians in this field, which will not be described in detail here.

[0093] Step S304: Obtain a boundary confidence index of each wavelength in the absorption peak to be adjusted as an adjustment wavelength interval according to the first boundary confidence index and the second boundary confidence index.

[0094] As an example, by changing the wavelength to be analyzed, the first boundary confidence index and the second boundary confidence index of each wavelength in each absorption peak to be adjusted as the adjustment wavelength interval can be obtained; then the first boundary confidence index and the second boundary confidence index of each wavelength in each absorption peak to be adjusted as the adjustment wavelength interval are multiplied and combined, and then linearly normalized to obtain the boundary confidence index of each wavelength in the absorption peak to be adjusted as the adjustment wavelength interval; in other examples, the implementer can also use other basic mathematical operations or related mapping methods such as addition or weighted combination to combine the two, which will not be repeated here.

[0095] By obtaining the boundary confidence index of the adjustment wavelength interval for each wavelength in each absorption peak to be adjusted, the adjustment wavelength interval of each absorption peak to be adjusted can be further obtained.

[0096] Preferably, in one embodiment of the present invention, considering that the absorption peak may be affected by the aliasing of the characteristic peaks corresponding to other components on the left and right sides, an aliasing intersection point can be determined on both sides thereof, thereby obtaining the adjusted wavelength interval; the adjusted wavelength interval accurately reflects the interval wavelength of the absorption peak corresponding to the known component, thereby facilitating the subsequent qualitative and quantitative analysis of the drug spectrum curve; therefore, the method for obtaining the adjusted wavelength interval includes:

[0097] In each wavelength interval corresponding to the absorption peak to be adjusted, the first wavelength interval and the second wavelength interval are obtained with the corresponding target characteristic wavelength as the dividing point; the wavelength corresponding to the maximum boundary confidence index in the first wavelength interval is taken as the left endpoint of the adjustment wavelength interval of the absorption peak to be adjusted, and the wavelength corresponding to the maximum boundary confidence index in the second wavelength interval is taken as the right endpoint of the adjustment wavelength interval of the absorption peak to be adjusted; the wavelength interval between the left endpoint and the right endpoint is taken as the corresponding adjustment wavelength interval.

[0098] Step S4, performing spectral analysis on the drug spectrum curve according to the adjustment wavelength range of each absorption peak to be adjusted and the corresponding wavelength range of each absorption peak not to be adjusted, to obtain all components and corresponding contents in the respiratory disease drug preparation.

[0099] In one embodiment of the present invention, after obtaining the adjustment wavelength range of each absorption peak to be adjusted, the drug spectral curve can be qualitatively and quantitatively analyzed in combination with the wavelength range corresponding to each absorption peak not to be adjusted, so as to determine all the components and the content of each component in the respiratory disease drug preparation to be identified. By determining the adjustment wavelength range of the absorption peak to be adjusted, the aliasing effect can be reduced, and the accuracy of qualitative and quantitative analysis of the drug spectral curve can be improved, thereby improving the accuracy of identification of drug preparations for treating respiratory diseases.

[0100] It should be noted that qualitative and quantitative analysis based on drug spectral curves is an existing technology well known to those skilled in the art and will not be described in detail here.

[0101] In one embodiment of the present invention, after obtaining all the ingredients and the content of each ingredient in the respiratory disease drug preparation to be identified, it is also possible to determine whether the respiratory disease drug preparation to be identified contains impurities based on the ingredient list of the respiratory disease drug preparation and other relevant pharmaceutical information, and judge whether the content or concentration of each ingredient meets the pharmaceutical standards, thereby evaluating whether the drug is abnormal or tracing abnormalities in the pharmaceutical process.

[0102] In summary, the present invention obtains the drug spectrum curve of the respiratory disease drug preparation and the standard absorption peak of each known component in the respiratory disease drug preparation; further obtains the target absorption peak of each known component in the drug spectrum curve; then analyzes and obtains the aliasing influence coefficient of the target absorption peak corresponding to each known component in the drug spectrum curve, and then screens out all absorption peaks to be adjusted from all target absorption peaks; then obtains the adjustment wavelength range of each absorption peak to be adjusted; according to the adjustment wavelength range of each absorption peak to be adjusted and the wavelength range corresponding to each non-adjusted absorption peak, the drug spectrum curve is spectrally analyzed to obtain all components and corresponding contents in the respiratory disease drug preparation. The present invention uses the spectral absorption peak of a single component as a standard reference, analyzes the aliasing influence of the drug spectrum curve, and then combines the characteristics of the difference in absorbance change after the absorption peak is affected by aliasing to accurately obtain the adjustment wavelength range of each absorption peak, avoiding the aliasing coverage interference of the absorption peak of the high-content component on the absorption peak of the low-content component when the traditional method performs qualitative and quantitative analysis on the drug spectrum curve, thereby improving the accuracy of qualitative and quantitative analysis of the drug spectrum curve, and also improving the accuracy of identification of drug preparations for treating respiratory diseases.

[0103] It should be noted that the sequence of the above embodiments of the present invention is only for description and does not represent the advantages and disadvantages of the embodiments. The processes depicted in the accompanying drawings do not necessarily require the specific order or continuous order shown to achieve the desired results. In some embodiments, multitasking and parallel processing are also possible or may be advantageous.

[0104] The various embodiments in this specification are described in a progressive manner, and the same or similar parts between the various embodiments can be referenced to each other, and each embodiment focuses on the differences from other embodiments.

Claims

1. A method for identifying a pharmaceutical preparation for treating respiratory diseases, characterized in that: The method comprises: Obtaining a drug spectrum curve of a respiratory disease drug preparation and a standard absorption peak of each known component in the respiratory disease drug preparation; According to the standard absorption peaks of all known components and the absorption peak characteristics of the drug spectrum curve, the target absorption peak of each known component in the drug spectrum curve is obtained; according to the offset of the target absorption peaks of all known components relative to the standard absorption peak, the aliasing influence coefficient of each known component corresponding to the target absorption peak in the drug spectrum curve is obtained; All absorption peaks to be adjusted are screened out from all the target absorption peaks according to the aliasing influence coefficient; according to the change of the absorbance of each absorption peak to be adjusted on both sides of each wavelength value, the boundary confidence index of each wavelength in the absorption peak to be adjusted as the adjustment wavelength interval is obtained; according to the boundary confidence index of each wavelength in each absorption peak to be adjusted as the adjustment wavelength interval, the adjustment wavelength interval of each absorption peak to be adjusted is obtained; According to the adjustment wavelength range of each absorption peak to be adjusted and the corresponding wavelength range of each absorption peak not to be adjusted, the drug spectrum curve is spectrally analyzed to obtain all components and corresponding contents in the respiratory disease drug preparation.

2. A method for identifying a pharmaceutical preparation for treating respiratory diseases according to claim 1, characterized in that: The method for obtaining the standard absorption peak comprises: Obtain a reference standard spectral curve for each known component in a respiratory disease pharmaceutical preparation; and use the absorption peak with the largest peak value in each of the reference standard spectral curves as the standard absorption peak of the corresponding known component.

3. A method for identifying a pharmaceutical preparation for treating respiratory diseases according to claim 1, characterized in that: The target absorption peak acquisition method comprises: Taking any known component as the component to be analyzed, taking the peak value corresponding wavelength of the standard absorption peak of the component to be analyzed as the standard characteristic wavelength; taking the peak value corresponding wavelength of each absorption peak in the drug spectrum curve as the characteristic wavelength of the corresponding absorption peak; Among the characteristic wavelengths of all absorption peaks in the drug spectral curve, the characteristic wavelength with the smallest difference from the standard characteristic wavelength of the component to be analyzed is used as the target characteristic wavelength of the component to be analyzed in the drug spectral curve, and the absorption peak corresponding to the target characteristic wavelength is used as the target absorption peak of the component to be analyzed in the drug spectral curve.

4. A method for identifying a pharmaceutical preparation for treating respiratory diseases according to claim 1, characterized in that: The method for obtaining the aliasing influence coefficient includes: Taking any known component as the component to be analyzed; obtaining a direct aliasing influence parameter of the component to be analyzed according to a peak difference between the peak value of the standard absorption peak of the component to be analyzed and the peak value of the target absorption peak; Obtaining the absorption peak characteristic parameters of each non-to-be-analyzed component according to the peak difference between the peak value of the standard absorption peak of each non-to-be-analyzed component and the peak value of the target absorption peak; obtaining the indirect aliasing influence parameters of the component to be analyzed by combining the absorption peak characteristic parameters of all non-to-be-analyzed components; According to the direct aliasing influence parameter and the indirect aliasing influence parameter of each known component, the aliasing influence coefficient of the target absorption peak corresponding to each known component in the drug spectrum curve is obtained.

5. A method for identifying a pharmaceutical preparation for treating respiratory diseases according to claim 4, characterized in that: The method for obtaining the direct aliasing impact parameter includes: The ratio between the peak value of the standard absorption peak of the component to be analyzed and the peak value of the target absorption peak is used as the characteristic deviation parameter of the component to be analyzed; the difference between the constant 1 and the characteristic deviation parameter is used as the direct aliasing influence parameter of the component to be analyzed.

6. A method for identifying a pharmaceutical preparation for treating respiratory diseases according to claim 4, characterized in that: The method for obtaining the indirect aliasing impact parameter includes: The ratio between the peak value of the standard absorption peak of each non-to-be-analyzed component and the peak value of the target absorption peak is used as the absorption peak characteristic parameter of each non-to-be-analyzed component; the absorption peak characteristic parameters of all non-to-be-analyzed components are averaged and then negatively correlated normalized, and the negative correlation normalization result is used as the indirect aliasing influence parameter of the component to be analyzed.

7. A method for identifying a pharmaceutical preparation for treating respiratory diseases according to claim 1, characterized in that: The method for obtaining the absorption peak to be adjusted comprises: The target absorption peak whose aliasing influence coefficient is greater than or equal to a preset threshold is used as the absorption peak to be adjusted.

8. A method for identifying a pharmaceutical preparation for treating respiratory diseases according to claim 1, characterized in that: The method for obtaining the boundary confidence index includes: Any wavelength in the wavelength range corresponding to each absorption peak to be adjusted is used as the wavelength to be analyzed; in the drug spectrum curve, a preset wavelength range is constructed with the wavelength to be analyzed as the center; in the preset wavelength range, the absorption peak to be adjusted is divided into a first absorption peak sub-segment and a second absorption peak sub-segment with the wavelength to be analyzed as the dividing point; In the drug spectrum curve, the difference in absorbance between the wavelength to be analyzed and the adjacent previous wavelength, and the sum of the difference in absorbance between the wavelength to be analyzed and the adjacent subsequent wavelength are used as the first boundary confidence index; Obtaining a second boundary confidence index according to a difference in absorbance changes between the first absorption peak subsegment and the second absorption peak subsegment; the difference in absorbance change is positively correlated with the second boundary confidence index; The boundary confidence index of each wavelength in the absorption peak to be adjusted as the adjustment wavelength interval is obtained according to the first boundary confidence index and the second boundary confidence index.

9. A method for identifying a pharmaceutical preparation for treating respiratory diseases according to claim 8, characterized in that: The method for obtaining the second boundary confidence index includes: The overall slope of the first absorption peak subsegment is taken as a first variation parameter, and the overall slope of the second absorption peak subsegment is taken as a second variation parameter; the difference between the first variation parameter and the second variation parameter is taken as a second boundary confidence index.

10. A method for identifying a pharmaceutical preparation for treating respiratory diseases according to claim 3, characterized in that: The method for obtaining the adjusted wavelength range includes: In each wavelength interval corresponding to the absorption peak to be adjusted, a first wavelength interval and a second wavelength interval are obtained by taking the corresponding target characteristic wavelength as a dividing point; the wavelength corresponding to the maximum boundary confidence index in the first wavelength interval is taken as the left endpoint of the adjustment wavelength interval of the absorption peak to be adjusted, and the wavelength corresponding to the maximum boundary confidence index in the second wavelength interval is taken as the right endpoint of the adjustment wavelength interval of the absorption peak to be adjusted; and the corresponding adjustment wavelength interval is determined using the left endpoint and the right endpoint.

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