A system and method for detecting stability of a vitamin preparation
By employing multispectral scanning and directional impact testing, the shortcomings in accuracy and coverage of existing vitamin preparation stability testing systems have been addressed. This enables efficient stability monitoring and quality assurance of vitamin preparations, improving testing accuracy and product reliability.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- CHINESE MEDICINES GUANGZHOU
- Filing Date
- 2026-02-24
- Publication Date
- 2026-07-10
AI Technical Summary
Existing vitamin formulation stability testing systems cannot accurately determine individualized degradation characteristics and dynamic spectral response changes. They suffer from problems such as excessive and frequent testing, missed risk assessments, and inappropriate quality screening. Furthermore, they lack the ability to identify the differential effects of spectral characteristics on the surface regions of different formulations and have weak spectral shift analysis capabilities, resulting in the inability to prioritize the analysis and quality assurance of key data in high-risk degradation areas.
The method employs multispectral scanning, directional impact testing, and zonal damage detection. Initial monitoring points and segmented areas are obtained through the sample batch management module. Multispectral scanning and comprehensive stress testing are performed to screen weak points and conduct directional impact tests. Combined with the deviation batch screening module, accurate quantitative detection and deviation batch screening are carried out to achieve dynamic weak point identification and impact direction adjustment.
It improves the accuracy and coverage of stability monitoring for vitamin preparations, enables efficient and accurate quality assessment, enhances product reliability and quality assurance efficiency, prevents assessment bias and missed detections, and ensures that quality control measures are highly consistent with actual degradation risks.
Smart Images
Figure CN122361348A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of pharmaceutical testing technology, specifically to a system and method for testing the stability of vitamin preparations. Background Technology
[0002] As core products in the fields of health food and pharmaceuticals, vitamin preparations need to withstand the degradation effects of multiple factors such as light, temperature and oxygen during storage and distribution. Their stability directly affects the product's shelf life and safety. Therefore, it is essential to build an individualized degradation assessment and intelligent stability detection system based on multispectral analysis for in-depth degradation status analysis and differentiated quality control.
[0003] In existing technologies, most vitamin preparation stability testing systems rely on a uniform stress test cycle strategy and fixed degradation threshold configuration, which cannot cover the individualized degradation characteristics and dynamic spectral response changes of different dosage forms and specifications under different stress conditions. Although existing technologies have introduced basic content detection mechanisms and periodic sampling functions, their degradation assessment dimensions are singular and highly dependent on industry-standard thresholds, making it difficult to accurately judge the true degradation state of the preparation, individualized abnormal patterns, and latent failure trends. When faced with complex multi-factor stress conditions or uneven degradation distribution on the surface of the preparation, problems such as frequent and excessive testing, missed risk assessments, and inappropriate quality screening standards are prone to occur.
[0004] Furthermore, existing technologies lack a mechanism to identify the differentiated impact of individualized spectral characteristics of different formulation surface regions under different stress cycles. This makes it impossible to effectively adjust degradation threshold parameters and conduct personalized stability assessments based on region-specific variations. In addition, existing systems suffer from defects such as weak spectral shift analysis capabilities, insufficient spatial interpolation of weak points, lack of analysis of the coupling state between photosensitivity, thermosensitivity, and oxidation, lack of priority mechanisms for batch deviation judgment, and low efficiency in monitoring resource utilization. As a result, key data from high-risk degradation areas cannot be prioritized for analysis and quality assurance. At the same time, there is a lack of adaptive impact direction adjustment strategies for different weak concentration levels of regions, and the inability to adaptively adjust the directional impact intensity and screening priority based on dynamic changes in real-time spectral response parameters and content deviation coefficients of the formulation. Summary of the Invention
[0005] The purpose of this invention is to provide a system and method for detecting the stability of vitamin preparations, which solves the problems existing in the background art.
[0006] To solve the above-mentioned technical problems, the present invention adopts the following technical solution: The first aspect of the present invention provides a vitamin preparation stability testing system, comprising: a sample batch management module, used to obtain the dosage form specifications of each batch of vitamin solid preparations to be tested, obtain each initial monitoring point and each segmentation region corresponding to each dosage form specification from a local database, and map each initial monitoring point and each segmentation region of each batch of samples to each preparation.
[0007] The spectral analysis module is used to perform multispectral scanning on each formulation of each batch of samples, collect initial spectral data of each formulation of each batch of samples at each initial monitoring point, conduct comprehensive stress tests on each formulation of each batch of samples, and perform a second multispectral scan after the experiment to obtain experimental spectral data of each formulation of each batch of samples at each initial monitoring point. This allows for the screening of each predicted weakness point of each spectral type of each formulation of each batch of samples, and the analysis of the impact direction of each spectral type of each batch of samples.
[0008] The directional impact test module is used to conduct multi-cycle progressively stronger directional impact tests based on the impact direction of each batch of samples and the spectral type.
[0009] The partitioned destruction detection module is used to perform destruction sampling and precise quantitative detection based on the partitioned regions of each formulation of each batch of samples after the directional impact test. This allows for the determination of the content values of each substance in each partitioned region of each formulation of each batch of samples, and the evaluation of the content deviation coefficient of each formulation in each partitioned region of each batch of samples.
[0010] The deviation batch screening module is used to analyze the deviation concentration hazard coefficient of each batch of samples based on the content deviation coefficient of each preparation in each segmentation region, thereby screening each batch of samples with deviation and sending them to the quality management personnel.
[0011] The second aspect of the present invention provides a method for detecting the stability of vitamin preparations, which is based on a vitamin preparation stability detection system, comprising: Step 1. Obtaining the dosage form specifications of each batch of samples of the solid vitamin preparation to be tested, obtaining each initial monitoring point and each segmentation region corresponding to each dosage form specification from a local database, and mapping each initial monitoring point and each segmentation region of each batch of samples to each preparation.
[0012] Step 2. Perform multispectral scanning on each formulation of each batch of samples, collect initial spectral data of each formulation of each batch of samples at each initial monitoring point, conduct comprehensive stress test on each formulation of each batch of samples, and perform a second multispectral scan after the experiment to obtain experimental spectral data of each formulation of each batch of samples at each initial monitoring point, thereby screening each estimated weak point of each spectral type of each formulation of each batch of samples, and analyzing the impact direction of each spectral type of each batch of samples accordingly.
[0013] Step 3. Conduct multi-cycle progressively stronger directional impact tests based on the impact direction of each batch of samples for each spectral type.
[0014] Step 4. After the directional impact test is completed, destructive sampling and precise quantitative detection are carried out according to the segmented regions of each formulation of each batch of samples to obtain the content value of each substance in each segmented region of each formulation of each batch of samples, and the content deviation coefficient of each formulation of each batch of samples in each segmented region is evaluated.
[0015] Step 5. Based on the content deviation coefficient of each preparation in each segmented region of each batch of samples, analyze the deviation concentration hazard coefficient of each batch of samples, thereby screening each batch of samples with deviation and sending them to the quality management personnel.
[0016] The beneficial effects of this invention are as follows: This invention improves the accuracy and coverage of vitamin preparation stability monitoring. Through degradation response calculation via multispectral data fusion and spectral shift field reconstruction of the preparation surface coordinate system, it can comprehensively capture the complex degradation state changes and stability differences on the preparation surface, thereby achieving efficient and accurate quality assessment. By analyzing fluorescence quenching rate, Raman peak shift, and near-infrared absorption increment, it improves the analytical accuracy and early warning response speed of preparation degradation state monitoring, significantly enhancing the quality assurance efficiency and product reliability level during the vitamin preparation factory testing process. Through detailed analysis of the spectral characteristics and dosage form geometric sensitivity of different coordinate regions on the preparation surface, a dynamic weak point identification mechanism is constructed, which can identify weak points based on the spectral shift field under different stress cycles. The system dynamically adjusts the impact direction layout and degradation prediction parameters based on the characteristics of the data, effectively preventing the omission of weak and concentrated areas by fixed-area monitoring, avoiding assessment bias and quality omissions caused by subjective judgment. Through spatial clustering analysis of weak and concentrated areas and principal component analysis of impact direction, the system can adjust the targeted impact strategy in real time according to the changes in the degradation performance of the formulation and the cumulative effect of the stress cycle, realizing intelligent allocation and differentiated investment of quality screening resources, effectively improving the pertinence and implementation effect of the deviation batch judgment scheme. Through accurate interpolation simulation of the spectral shift field of the formulation surface, combined with radial basis function interpolation method and edge attenuation correction technology, the system identifies the concentrated abnormal areas of degradation that threaten the stability of the formulation, ensuring a high degree of consistency between quality control measures and actual degradation failure risks. Attached Figure Description
[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.
[0018] Figure 1 This is a schematic diagram of the system modules of the present invention.
[0019] Figure 2 This is a schematic diagram of the method flow of the present invention. Detailed Implementation
[0020] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.
[0021] Reference Figure 1 As shown, the first aspect of the present invention provides a vitamin preparation stability testing system, comprising: a sample batch management module, a spectral analysis module, a directional impact test module, a zoned destruction detection module, and a deviation batch screening module.
[0022] It should be noted that the sample batch management module is connected to the spectral analysis module, the spectral analysis module is connected to the directional impact test module, the directional impact test module is connected to the zonal damage detection module, and the zonal damage detection module is connected to the deviation batch screening module.
[0023] The sample batch management module is used to obtain the dosage form specifications of each batch of vitamin solid dosage forms to be tested, retrieve the initial monitoring points and segmentation regions corresponding to each dosage form specification from the local database, and map the initial monitoring points and segmentation regions of each preparation to which each batch of samples belongs.
[0024] In one specific embodiment, the dosage form specifications of each batch of samples of the vitamin solid preparation to be tested are obtained by retrieving the dosage form specifications of each batch of samples of the vitamin solid preparation to be tested from a local database.
[0025] It should be noted that each segmentation region is determined by the researchers. For example, for a cylindrical solid vitamin preparation, dividing it into 8 equal parts will yield each segmentation region.
[0026] It should also be noted that the local database is used for each initial monitoring point and segmentation region corresponding to each dosage form and specification, the stress cycle duration of the comprehensive stress test, the formulation surface coordinate system corresponding to each dosage form and specification, the fluorescence quenching rate threshold, the full coordinate position sequence of the formulation surface coordinate system, the coordinate grid spacing parameter corresponding to each dosage form and specification, the kernel function type and shape parameter of the radial basis function, the neighborhood radius parameter and minimum number of points parameter of spatial clustering, the impact parameter sequence corresponding to each spectral type, the standard content value of each substance in each batch of samples, the orientation number of each segmentation region, the content deviation coefficient threshold, each photosensitive substance, and the comprehensive hazard coefficient threshold.
[0027] The spectral analysis module is used to perform multispectral scanning on each formulation of each batch of samples, collect initial spectral data of each formulation of each batch of samples at each initial monitoring point, conduct comprehensive stress tests on each formulation of each batch of samples, and perform a second multispectral scan after the experiment to obtain experimental spectral data of each formulation of each batch of samples at each initial monitoring point. This allows for the screening of each predicted weakness point of each spectral type of each formulation of each batch of samples, and the analysis of the impact direction of each spectral type of each batch of samples.
[0028] It should be noted that multispectral scanning is a non-contact scanning method. By using scanning methods such as near-infrared spectroscopy, the initial spectral data of each batch of samples and each formulation at each initial monitoring point can be obtained.
[0029] It should also be noted that the initial spectral data includes: initial near-infrared spectral data, initial Raman spectral data, and initial fluorescence spectral data.
[0030] In a specific embodiment of the present invention, experimental spectral data of each formulation of each batch of samples at each initial monitoring point are obtained. The specific method is as follows: each formulation of each batch of samples is placed in a comprehensive stress chamber, and preset standard light intensity, standard stress temperature and standard oxygen partial pressure are applied simultaneously.
[0031] The stress cycle duration of the comprehensive stress test was obtained from the local database. After the stress cycle duration ended, a second multispectral scan was performed on each formulation of each batch of samples at each initial monitoring point. Experimental near-infrared spectral data, experimental Raman spectral data, and experimental fluorescence spectral data of each formulation of each batch of samples at each initial monitoring point were collected and used as the experimental spectral data of each formulation of each batch of samples at each initial monitoring point.
[0032] In a specific embodiment of the present invention, the estimated weak points of each spectral type of each formulation belonging to each batch of samples are screened. The specific method is as follows: based on the initial spectral data and experimental spectral data of each formulation belonging to each batch of samples at each initial monitoring point, the fluorescence quenching rate, Raman peak position shift and near-infrared absorption increment of each formulation belonging to each batch of samples at each initial monitoring point are calculated.
[0033] In one specific embodiment, the fluorescence quenching rate, Raman peak position shift, and near-infrared absorption increment of each formulation belonging to each batch of samples at each initial monitoring point are calculated. The specific method is as follows: based on the initial fluorescence spectral data of each formulation belonging to each batch of samples at each initial monitoring point, the initial fluorescence peak intensity of each initial monitoring point is extracted; based on the experimental fluorescence spectral data of each initial monitoring point, the experimental fluorescence peak intensity of each initial monitoring point is extracted; the difference between the initial fluorescence peak intensity and the experimental fluorescence peak intensity is divided by the initial fluorescence peak intensity to obtain the fluorescence quenching rate of each initial monitoring point. The initial Raman spectral data and experimental Raman spectral data of the initial monitoring points are used to extract the initial Raman characteristic peak positions and experimental Raman characteristic peak positions of each initial monitoring point. The difference between the two is calculated to obtain the Raman peak position shift of each initial monitoring point. Based on the initial near-infrared spectral data and experimental near-infrared spectral data of each initial monitoring point, the initial near-infrared characteristic absorption value and experimental near-infrared characteristic absorption value of each initial monitoring point are extracted. The experimental near-infrared characteristic absorption value is subtracted from the initial near-infrared characteristic absorption value to obtain the near-infrared absorption increment of each initial monitoring point.
[0034] The formulation surface coordinate system corresponding to each dosage form and specification is obtained from the local database. Based on this, the coordinate positions of each initial monitoring point of each formulation of each batch of samples in the formulation surface coordinate system and its fluorescence quenching rate are obtained. The spectral offset field of the formulation surface coordinate system is completed by spatial interpolation method, so as to obtain the estimated fluorescence quenching rate of each formulation of each batch of samples at each coordinate position in the formulation surface coordinate system.
[0035] The fluorescence quenching rate threshold is obtained from the local database. Based on the estimated fluorescence quenching rate of each formulation of each batch of samples at each coordinate position on the formulation surface coordinate system, it is compared with the fluorescence quenching rate threshold to screen each photosensitive weak point of each formulation of each batch of samples. Similarly, each thermosensitive weak point and each oxidation weak point of each formulation of each batch of samples are analyzed and used as each estimated weak point of each spectral type of each formulation of each batch of samples.
[0036] In one specific embodiment, the method for screening each photosensitive weak point of each formulation to which each batch of samples belongs is as follows: if the estimated fluorescence quenching rate of a certain formulation to which a certain batch of samples belongs is greater than the fluorescence quenching rate threshold at a certain coordinate position on the formulation surface coordinate system, then the coordinate position is marked as a photosensitive weak point, thereby screening each photosensitive weak point of each formulation to which each batch of samples belongs.
[0037] In a specific embodiment of the present invention, the estimated fluorescence quenching rate of each formulation belonging to each batch of samples at each coordinate position on the formulation surface coordinate system is obtained. The specific method is as follows: based on the estimated fluorescence quenching rate of each initial monitoring point of each formulation belonging to each batch of samples at the coordinate position on the formulation surface coordinate system, it is used as the fluorescence quenching rate sample set of each formulation belonging to each batch of samples.
[0038] The full coordinate position sequence of the formulation surface coordinate system is obtained from the local database. Based on the fluorescence quenching rate sample set of each formulation to which each batch of samples belongs, the spectral shift characteristics of each coordinate position in the full coordinate position sequence are estimated by radial basis function interpolation, so as to obtain the estimated fluorescence quenching rate of each formulation to which each batch of samples belongs at each coordinate position.
[0039] It should be noted that the full coordinate position sequence of the formulation surface coordinate system refers to the set of all coordinate points generated after uniformly discretizing the formulation surface according to the formulation surface coordinate system corresponding to each dosage form and specification, and according to the preset coordinate grid spacing. The coordinate grid spacing parameters corresponding to each dosage form and specification are obtained from the local database. Based on the coordinate range and coordinate grid spacing parameters of the formulation surface coordinate system, grid nodes covering the entire formulation surface are generated in the formulation surface coordinate system in an equally spaced manner. The coordinates of each grid node constitute the full coordinate position sequence of the formulation surface coordinate system. The number of coordinate positions contained in this sequence is much greater than the number of initial monitoring points.
[0040] In one specific embodiment, spectral shift feature prediction is performed to obtain the estimated fluorescence quenching rate of each formulation belonging to each batch of samples at each coordinate position. The specific method is as follows: based on the fluorescence quenching rate sample set of each formulation belonging to each batch of samples, the coordinate positions of each initial monitoring point in the formulation surface coordinate system and their corresponding fluorescence quenching rates are extracted as known sample points. The kernel function type and shape parameters of the radial basis function are obtained from the local database. Based on the spatial distance between each known sample point, a radial basis function interpolation matrix is constructed. The interpolation weight coefficients of each known sample point are obtained by solving a system of linear equations. Each coordinate position in the full coordinate position sequence of the formulation surface coordinate system is traversed, and the spatial distance between each coordinate position and each known sample point is calculated. The radial basis function value of each coordinate position to each known sample point is calculated according to the kernel function type. The radial basis function value and the corresponding interpolation weight coefficient are weighted and summed to obtain the estimated fluorescence quenching rate of each formulation belonging to each batch of samples at each coordinate position.
[0041] It should be noted that the radial basis function interpolation method is an existing technology. Its kernel function types include Gaussian kernel function, multiquadric surface kernel function, inverse multiquadric surface kernel function, and thin plate spline kernel function, etc. The shape parameter is used to control the decay rate of the kernel function, which is selected by researchers according to the distribution density of monitoring points and the interpolation accuracy requirements.
[0042] In a specific embodiment of the present invention, the impact direction of each spectral type of each batch of samples is analyzed. The specific method is as follows: based on the coordinate position of each photosensitive weak point of each formulation to which each batch of samples belongs in the formulation surface coordinate system, the degree of aggregation of the photosensitive weak points of each formulation to which each batch of samples belongs is analyzed by spatial clustering algorithm, thereby screening each photosensitive weak concentrated region to which each batch of samples belongs, and taking the geometric center coordinates of each photosensitive weak concentrated region as each photosensitive impact point to which each batch of samples belongs, and the photosensitive impact direction of each batch of samples is obtained accordingly.
[0043] In one specific embodiment, the degree of clustering of photosensitive weak points in each formulation of each batch of samples is analyzed to screen the concentrated areas of photosensitive weak points in each formulation of each batch of samples. The specific method is as follows: Based on the coordinate position of each photosensitive weak point in each formulation of each batch of samples in the coordinate system of the formulation surface, a set of coordinates of photosensitive weak points in each formulation of each batch of samples is constructed. The neighborhood radius parameter and minimum number of points parameter of spatial clustering are obtained from the local database. Based on the neighborhood radius parameter, the spatial distance between each photosensitive weak point and other photosensitive weak points is calculated. The number of neighborhood points within the neighborhood radius of each photosensitive weak point is counted. If the number of neighborhood points of a photosensitive weak point is greater than or equal to the minimum number of points parameter, the photosensitive weak point is marked as a core point. Each core point and the interconnected photosensitive weak points within its neighborhood are divided into the same cluster. The area covered by each cluster is taken as the concentrated areas of photosensitive weak points in each formulation of each batch of samples.
[0044] It should be noted that the spatial clustering method described above uses the DBSCAN density clustering algorithm, which is an existing technology.
[0045] Similarly, the thermal shock points and oxidation shock points of each formulation of each batch of samples were obtained through analysis. Based on this, the thermal shock direction and oxidation shock direction of each batch of samples were analyzed, and these, together with the photosensitive shock direction, were used as the shock direction of each spectral type of each batch of samples.
[0046] In a specific embodiment of the present invention, the photosensitive impact direction of each batch of samples is analyzed and obtained. The specific method is as follows: based on the photosensitive impact points of each formulation to which each batch of samples belongs, the coordinate positions of each photosensitive impact point of each formulation to which each batch of samples belongs in the formulation surface coordinate system are obtained, and the average coordinate value of all photosensitive impact points in each batch of samples is calculated and used as the photosensitive impact center of each batch of samples.
[0047] In one specific embodiment, the mean coordinate value of all photosensitive impact points in each batch of samples is calculated as follows: based on the coordinate position of each photosensitive impact point in the formulation surface coordinate system of each batch of samples, the abscissa and ordinate values of each photosensitive impact point are extracted. The abscissa values of all photosensitive impact points in each batch of samples are summed and divided by the total number of photosensitive impact points to obtain the mean abscissa of the photosensitive impact points in each batch of samples. The ordinate values of all photosensitive impact points in each batch of samples are summed and divided by the total number of photosensitive impact points to obtain the mean ordinate of the photosensitive impact points in each batch of samples. The mean abscissa and ordinate values of the photosensitive impact points are combined to obtain the mean coordinate value of all photosensitive impact points in each batch of samples.
[0048] Based on the orientational distribution of each photosensitive impact point relative to the photosensitive impact center of each batch of samples, the principal direction vector of the photosensitive impact point distribution is extracted by principal component analysis and used as the photosensitive impact direction of each batch of samples.
[0049] In one specific embodiment, the principal direction vector of the photosensitive impact point distribution is extracted. The specific method is as follows: based on the coordinate position of each photosensitive impact point of each formulation to which each batch of samples belongs in the formulation surface coordinate system, the coordinates of each photosensitive impact point are subtracted from the coordinates of the photosensitive impact center to obtain the centralized coordinates of each photosensitive impact point. Based on the centralized coordinates of each photosensitive impact point, a photosensitive impact point coordinate matrix is constructed. The covariance matrix of the coordinate matrix is calculated. The covariance matrix is decomposed into eigenvalues to obtain each eigenvalue and its corresponding eigenvector. The eigenvector corresponding to the largest eigenvalue is selected and used as the principal direction vector of the photosensitive impact point distribution, thereby obtaining the photosensitive impact direction of each batch of samples.
[0050] It should be noted that the principal component analysis method described above is an existing technology, which characterizes the overall distribution trend of photosensitive impact points by extracting the principal direction of data distribution.
[0051] The directional impact test module is used to conduct multi-cycle progressively stronger directional impact tests based on the impact direction of each batch of samples and the spectral type.
[0052] In one specific embodiment, a multi-cycle progressively stronger directional impact test is conducted. The specific method is as follows: Impact parameter sequences corresponding to each spectral type are obtained from a local database. The photosensitive impact parameter sequence contains multi-cycle progressively increasing light intensity values, the thermosensitive impact parameter sequence contains multi-cycle progressively increasing stress temperature values, and the oxidation impact parameter sequence contains multi-cycle progressively increasing oxygen partial pressure values. Based on the photosensitive impact direction of each batch of samples, the illumination angle of the light source is adjusted to align with the photosensitive impact direction. The light intensity of each cycle is then applied sequentially according to the photosensitive impact parameter sequence. Based on the thermosensitive impact direction of each batch of samples, the arrangement position of the heating element is adjusted to align with the thermosensitive impact direction. The stress temperature of each cycle is then applied sequentially according to the thermosensitive impact parameter sequence. Based on the oxidation impact direction of each batch of samples, the oxygen inlet direction is adjusted to align with the oxidation impact direction. The oxygen partial pressure of each cycle is then applied sequentially according to the oxidation impact parameter sequence, thereby completing the multi-cycle progressively stronger directional impact test.
[0053] The partitioned destruction detection module is used to perform destruction sampling and precise quantitative detection based on the partitioned regions of each formulation of each batch of samples after the directional impact test. This allows for the determination of the content values of each substance in each partitioned region of each formulation of each batch of samples, and the evaluation of the content deviation coefficient of each formulation in each partitioned region of each batch of samples.
[0054] In one specific embodiment, the content values of each substance in each segmented region of each batch of samples are obtained by the following method: based on each segmented region of each batch of samples, each preparation is physically cut and sampled according to the boundary of each segmented region. The sampled samples from each segmented region are dissolved and prepared into test solutions. The test solutions of each segmented region are detected by high performance liquid chromatography (HPLC) using existing technology to obtain the chromatographic peak area of each substance in each segmented region. The content values of each substance in each segmented region of each batch of samples are calculated using existing chromatographic peak area calculation technology.
[0055] In a specific embodiment of the present invention, the content deviation coefficient of each formulation of each batch of samples in each segmented region is evaluated. The specific method is to obtain the standard content value of each substance of each batch of samples from the local database.
[0056] Based on the content values of each substance in each segmented region of each batch of samples and the corresponding standard content values of each preparation, the degradation rate of each substance in each segmented region of each batch of samples is calculated, and the content deviation coefficient of each preparation in each segmented region of each batch of samples is obtained by summing.
[0057] In one specific embodiment, the degradation rate of each substance in each fractionated region of each formulation belonging to each batch of samples is calculated. The specific method is as follows: based on the content values of each substance in each fractionated region of each formulation belonging to each batch of samples... Comparison with corresponding standard content values , where x represents the batch number of each sample. y is a positive integer greater than 2, and n represents the number of each preparation. m is a positive integer greater than 2, and i represents the number of each segmented region. j is a positive integer greater than 2, and p represents the number of each substance. q is a positive integer greater than 2. Calculate the degradation rate of each substance in each fractionated region for each formulation of each batch of samples. .
[0058] The deviation batch screening module is used to analyze the deviation concentration hazard coefficient of each batch of samples based on the content deviation coefficient of each preparation in each segmentation region, thereby screening each batch of samples with deviation and sending them to the quality management personnel.
[0059] In a specific embodiment of the present invention, the deviation concentration hazard coefficient of each batch of samples is analyzed to screen each batch of samples with deviation. The specific method is as follows: based on the content deviation coefficient of each preparation of each batch of samples in each segmented region, each hazard segmented region of each preparation of each batch of samples is screened. The location number of each segmented region is obtained from the local database. The location number of each hazard segmented region of each preparation of each batch of samples is extracted. The hazard segmented regions of each preparation of each batch of samples on each location number are mapped. The number of hazard segmented regions of each batch of samples on each location number is counted. The number of regions and concentration hazard coefficient of each batch of samples are calculated.
[0060] In one specific embodiment, the method for screening each hazardous segmentation region of each batch of samples to which each formulation belongs is as follows: obtain the content deviation coefficient threshold from the local database; if the content deviation coefficient of a certain batch of samples to which a certain formulation belongs in a certain segmentation region is greater than the content deviation coefficient threshold, then mark the segmentation region as a hazardous segmentation region, thereby screening each hazardous segmentation region of each batch of samples to which each formulation belongs.
[0061] In one specific embodiment, the number of regions and the concentration hazard coefficient of each batch of samples are calculated by: based on the number of hazard segmentation regions of each batch of samples in each direction number. , where r represents the number of each location. , where w is a positive integer greater than 2, calculate the number of regions and the concentration hazard coefficient for each batch of samples. , where e represents the natural constant.
[0062] Based on the photosensitive impact points, thermosensitive impact points, and oxidative impact points of each batch of samples, the impact point concentration hazard coefficient of each batch of samples was analyzed. The deviation concentration hazard coefficient of each batch of samples was obtained by adding the area number and concentration hazard coefficient of each batch of samples together.
[0063] Based on the degradation rate of each substance in each fractionated region of each batch of samples and the photosensitive impact direction of each batch of samples, the degradation hazard coefficient of photosensitive substance content of each batch of samples is calculated. Similarly, the degradation hazard coefficients of thermosensitive substance content and oxidizing substance content of each batch of samples are obtained. Combined with the deviation concentration hazard coefficient of each batch of samples, the comprehensive hazard coefficient of each batch of samples is obtained.
[0064] In one specific embodiment, the degradation hazard coefficient of each batch of samples is calculated as follows: Photosensitive substances are retrieved from a local database. Based on the degradation rate of each substance in each segmented region of each formulation belonging to each batch of samples, the degradation rate of photosensitive substances in each formulation belonging to each batch of samples at each directional number is obtained. The directional number in each formulation belonging to each batch of samples in the same direction as the photosensitive impact direction is taken as the target directional number, and other directional numbers are marked as non-impact directional numbers. Thus, the degradation rate of photosensitive substances in each formulation belonging to each batch of samples at the target directional number is obtained. The degradation rate of photosensitive related substances at each non-impact orientation number. Where t represents the number of each non-impact azimuth. w is a positive integer greater than 2, and u represents the number of each photosensitive substance. Let k be a positive integer greater than 2. Calculate the degradation hazard coefficient for each batch of samples. .
[0065] It should be noted that the degradation rates of photosensitive substances at the target azimuth number are directly affected by the impact, so the original values are added together when calculating the degradation hazard coefficient. However, the degradation rates of photosensitive substances at non-impact azimuth numbers are indirectly affected, so parameter adjustments are needed to appropriately increase their values. For example, if the content deviation coefficient of a photosensitive substance at the target azimuth number is 0.5, and the degradation rate of the same substance at a non-impact azimuth number is also 0.5, since the impact azimuth number is not directly affected, under the same degradation rate, the impact azimuth number that is not directly affected will cause greater harm due to degradation than the target azimuth number that is directly affected.
[0066] The comprehensive hazard coefficient threshold is obtained from the local database, and the deviation concentration hazard coefficient of each batch of samples is compared to screen the samples of each deviation batch.
[0067] In one specific embodiment, the method for screening each deviation batch of samples is as follows: if the deviation concentration hazard coefficient of a certain batch of samples is greater than the comprehensive hazard coefficient threshold, then the batch of samples is marked as a deviation batch of samples, thereby screening each deviation batch of samples.
[0068] In a specific embodiment of the present invention, the concentrated hazard coefficient of impact points of each batch of samples is analyzed. The specific method is as follows: based on each photosensitive impact point of each formulation to which each batch of samples belongs, and combined with each segmented region of each formulation to which each batch of samples belongs, the number of photosensitive impact points of each formulation to which each batch of samples belongs in each segmented region is counted, and the percentage of the number of photosensitive impact points of each formulation to which each batch of samples belongs on each directional number is calculated accordingly, thereby calculating the concentrated hazard coefficient of photosensitive impact points of each batch of samples.
[0069] In one specific embodiment, the percentage of photosensitive impact points of each formulation belonging to each batch of samples on each directional number is calculated to obtain the concentrated hazard coefficient of photosensitive impact points of each batch of samples. The specific method is as follows: based on the number of photosensitive impact points of each formulation belonging to each batch of samples in each segmented region, and according to the directional number of each hazard segmented region belonging to each formulation belonging to each batch of samples, the number of photosensitive impact points of each formulation belonging to each batch of samples on each directional number is mapped to obtain the number of photosensitive impact points of each formulation belonging to each batch of samples on each directional number, and the percentage is summed to obtain the concentrated hazard coefficient of photosensitive impact points of each batch of samples.
[0070] Based on the thermal shock points and oxidation shock points of each batch of samples and each formulation, the concentrated hazard coefficients of the thermal shock points and oxidation shock points of each batch of samples are calculated in the same way, thereby calculating the concentrated hazard coefficient of the shock points of each batch of samples.
[0071] Reference Figure 2 As shown, the second aspect of the present invention provides a method for detecting the stability of vitamin preparations, which is based on a vitamin preparation stability detection system, including: Step 1. Obtaining the dosage form specifications of each batch of samples of the solid vitamin preparation to be tested, obtaining each initial monitoring point and each segmented region corresponding to each dosage form specification from a local database, and mapping each initial monitoring point and each segmented region of each batch of samples to each preparation.
[0072] Step 2. Perform multispectral scanning on each formulation of each batch of samples, collect initial spectral data of each formulation of each batch of samples at each initial monitoring point, conduct comprehensive stress test on each formulation of each batch of samples, and perform a second multispectral scan after the experiment to obtain experimental spectral data of each formulation of each batch of samples at each initial monitoring point, thereby screening each estimated weak point of each spectral type of each formulation of each batch of samples, and analyzing the impact direction of each spectral type of each batch of samples accordingly.
[0073] Step 3. Conduct multi-cycle progressively stronger directional impact tests based on the impact direction of each batch of samples for each spectral type.
[0074] Step 4. After the directional impact test is completed, destructive sampling and precise quantitative detection are carried out according to the segmented regions of each formulation of each batch of samples to obtain the content value of each substance in each segmented region of each formulation of each batch of samples, and the content deviation coefficient of each formulation of each batch of samples in each segmented region is evaluated.
[0075] Step 5. Based on the content deviation coefficient of each preparation in each segmented region of each batch of samples, analyze the deviation concentration hazard coefficient of each batch of samples, thereby screening each batch of samples with deviation and sending them to the quality management personnel.
[0076] All formulas in this manual are dimensionless and calculated numerically. The formulas are derived from software simulations based on a large amount of collected data to obtain the most recent real-world results. The preset parameters and thresholds in the formulas are set by those skilled in the art according to the actual situation.
[0077] The above content is merely an example and illustration of the concept of the present invention. Those skilled in the art can make various modifications or additions to the specific embodiments described, or use similar methods to replace them, as long as they do not deviate from the concept of the invention or exceed the scope defined by the present invention, and all such modifications and additions should fall within the protection scope of the present invention.
Claims
1. A vitamin preparation stability testing system, characterized in that, include: The sample batch management module is used to obtain the dosage form specifications of each batch of vitamin solid dosage forms to be tested, obtain the initial monitoring points and segmentation regions corresponding to each dosage form specification from the local database, and map the initial monitoring points and segmentation regions of each preparation to which each batch of samples belongs. The spectral analysis module is used to perform multispectral scanning on each formulation of each batch of samples, collect the initial spectral data of each formulation of each batch of samples at each initial monitoring point, conduct comprehensive stress tests on each formulation of each batch of samples, and perform a second multispectral scan after the experiment to obtain the experimental spectral data of each formulation of each batch of samples at each initial monitoring point. This allows for the screening of each estimated weak point of each spectral type of each formulation of each batch of samples, and the analysis of the impact direction of each spectral type of each batch of samples. The directional impact testing module is used to conduct multi-cycle progressively stronger directional impact tests based on the impact direction of each batch of samples and each spectral type. The partitioned destruction detection module is used to perform destruction sampling and precise quantitative detection based on the segmented regions of each formulation of each batch of samples after the directional impact test, so as to obtain the content value of each substance in each segmented region of each formulation of each batch of samples, and evaluate the content deviation coefficient of each formulation of each batch of samples in each segmented region. The deviation batch screening module is used to analyze the deviation concentration hazard coefficient of each batch of samples based on the content deviation coefficient of each preparation in each segmentation region, thereby screening each batch of samples with deviation and sending them to the quality management personnel.
2. The vitamin preparation stability testing system according to claim 1, characterized in that, The specific method for obtaining the experimental spectral data of each formulation belonging to each batch of samples at each initial monitoring point is as follows: Each batch of samples and its corresponding formulations were placed in a comprehensive stress chamber, and preset standard light intensity, standard stress temperature and standard oxygen partial pressure were applied simultaneously. The stress cycle duration of the comprehensive stress test was obtained from the local database. After the stress cycle duration ended, a second multispectral scan was performed on each formulation of each batch of samples at each initial monitoring point. Experimental near-infrared spectral data, experimental Raman spectral data, and experimental fluorescence spectral data of each formulation of each batch of samples at each initial monitoring point were collected and used as the experimental spectral data of each formulation of each batch of samples at each initial monitoring point.
3. The vitamin preparation stability detection system according to claim 1, characterized in that, The specific method for screening the predicted weak points of each spectral type of each formulation belonging to each batch of samples is as follows: Based on the initial spectral data and experimental spectral data of each formulation of each batch of samples at each initial monitoring point, the fluorescence quenching rate, Raman peak position shift and near-infrared absorption increment of each formulation of each batch of samples at each initial monitoring point are calculated. The formulation surface coordinate system corresponding to each dosage form and specification is obtained from the local database. Based on this, the coordinate positions of each initial monitoring point of each batch of samples and their fluorescence quenching rate in the formulation surface coordinate system are obtained. The spectral shift field of the formulation surface coordinate system is completed by spatial interpolation method, so as to obtain the estimated fluorescence quenching rate of each batch of samples and their respective formulations in the formulation surface coordinate system. The fluorescence quenching rate threshold is obtained from the local database. Based on the estimated fluorescence quenching rate of each formulation of each batch of samples at each coordinate position on the formulation surface coordinate system, it is compared with the fluorescence quenching rate threshold to screen each photosensitive weak point of each formulation of each batch of samples. Similarly, each thermosensitive weak point and each oxidation weak point of each formulation of each batch of samples are analyzed and used as each estimated weak point of each spectral type of each formulation of each batch of samples.
4. The vitamin preparation stability testing system according to claim 3, characterized in that, The method for obtaining the estimated fluorescence quenching rate of each batch of samples at each coordinate position on the formulation surface coordinate system is as follows: Based on the estimated fluorescence quenching rate of each initial monitoring point in the formulation surface coordinate system of each batch of samples, the fluorescence quenching rate sample set of each formulation of each batch of samples is used as the sample set of fluorescence quenching rate of each batch of samples. The full coordinate position sequence of the formulation surface coordinate system is obtained from the local database. Based on the fluorescence quenching rate sample set of each formulation to which each batch of samples belongs, the spectral shift characteristics of each coordinate position in the full coordinate position sequence are estimated by radial basis function interpolation, so as to obtain the estimated fluorescence quenching rate of each formulation to which each batch of samples belongs at each coordinate position.
5. The vitamin preparation stability testing system according to claim 3, characterized in that, The specific method for analyzing the impact direction of each spectral type in each batch of samples is as follows: Based on the coordinates of each photosensitive weak point in each formulation of each batch of samples in the formulation surface coordinate system, the degree of aggregation of photosensitive weak points in each formulation of each batch of samples is analyzed by spatial clustering algorithm, thereby screening out each concentrated area of photosensitive weak points in each formulation of each batch of samples. The geometric center coordinates of each concentrated area of photosensitive weak points are taken as each photosensitive impact point in each formulation of each batch of samples, and the photosensitive impact direction of each batch of samples is obtained accordingly. Similarly, the thermal shock points and oxidation shock points of each formulation of each batch of samples were obtained through analysis. Based on this, the thermal shock direction and oxidation shock direction of each batch of samples were analyzed, and these, together with the photosensitive shock direction, were used as the shock direction of each spectral type of each batch of samples.
6. The vitamin preparation stability testing system according to claim 5, characterized in that, The analysis yielded the photosensitive impact direction for each batch of samples, and the specific method used was as follows: Based on the photosensitive impact points of each batch of samples and each formulation, the coordinate positions of each photosensitive impact point of each batch of samples and each formulation in the formulation surface coordinate system are obtained, and the average coordinate value of all photosensitive impact points in each batch of samples is calculated and used as the photosensitive impact center of each batch of samples. Based on the orientational distribution of each photosensitive impact point relative to the photosensitive impact center of each batch of samples, the principal direction vector of the photosensitive impact point distribution is extracted by principal component analysis and used as the photosensitive impact direction of each batch of samples.
7. The vitamin preparation stability testing system according to claim 5, characterized in that, The specific method for evaluating the content deviation coefficient of each formulation in each batch of samples in each fractionation region is as follows: Obtain the standard content values of each substance in each batch of samples from the local database; Based on the content values of each substance in each segmented region of each batch of samples and the corresponding standard content values of each preparation, the degradation rate of each substance in each segmented region of each batch of samples is calculated, and the content deviation coefficient of each preparation in each segmented region of each batch of samples is obtained by summing.
8. The vitamin preparation stability detection system according to claim 7, characterized in that, The method for analyzing the concentrated hazard coefficient of deviation in each batch of samples, and thus screening samples from each batch with deviation, is as follows: Based on the content deviation coefficient of each formulation of each batch of samples in each segmented region, each hazardous segmented region of each formulation of each batch of samples is screened. The location number of each segmented region is obtained from the local database. The location number of each hazardous segmented region of each formulation of each batch of samples is extracted. The hazardous segmented regions of each formulation of each batch of samples at each location number are mapped. The number of hazardous segmented regions of each batch of samples at each location number is counted. The number of regions and the concentration hazard coefficient of each batch of samples are calculated. Based on the photosensitive impact points, thermosensitive impact points and oxidative impact points of each batch of samples, the impact point concentration hazard coefficient of each batch of samples was analyzed. The deviation concentration hazard coefficient of each batch of samples was obtained by adding the area number and concentration hazard coefficient of each batch of samples together. Based on the degradation rate of each substance in each fractionation region of each batch of samples and the photosensitive impact direction of each batch of samples, the degradation hazard coefficient of photosensitive substance content of each batch of samples is calculated. Similarly, the degradation hazard coefficients of thermosensitive substance content and oxidizing substance content of each batch of samples are obtained. Combined with the deviation concentration hazard coefficient of each batch of samples, the comprehensive hazard coefficient of each batch of samples is obtained. The comprehensive hazard coefficient threshold is obtained from the local database, and the deviation concentration hazard coefficient of each batch of samples is compared to screen the samples of each deviation batch.
9. The vitamin preparation stability testing system according to claim 8, characterized in that, The specific method for analyzing the impact point concentration hazard coefficient of each batch of samples is as follows: Based on the photosensitive impact points of each formulation of each batch of samples, and combined with the segmented regions of each formulation of each batch of samples, the number of photosensitive impact points of each formulation of each batch of samples in each segmented region is counted, and the percentage of photosensitive impact points of each formulation of each batch of samples in each directional number is calculated accordingly, thereby calculating the concentrated hazard coefficient of photosensitive impact points of each batch of samples. Based on the thermal shock points and oxidation shock points of each batch of samples and each formulation, the concentrated hazard coefficients of the thermal shock points and oxidation shock points of each batch of samples are calculated in the same way, thereby calculating the concentrated hazard coefficient of the shock points of each batch of samples.
10. A method for detecting the stability of vitamin preparations, implemented based on the vitamin preparation stability detection system according to any one of claims 1-9, characterized in that, include: Step 1. Obtain the dosage form specifications of each batch of vitamin solid dosage form samples to be tested, obtain the initial monitoring points and segmentation regions corresponding to each dosage form specification from the local database, and map the initial monitoring points and segmentation regions of each batch of samples to each preparation. Step 2. Perform multispectral scanning on each formulation of each batch of samples, collect initial spectral data of each formulation of each batch of samples at each initial monitoring point, conduct comprehensive stress test on each formulation of each batch of samples, and perform a second multispectral scan after the experiment to obtain experimental spectral data of each formulation of each batch of samples at each initial monitoring point, thereby screening each estimated weak point of each spectral type of each formulation of each batch of samples, and analyzing the impact direction of each spectral type of each batch of samples accordingly. Step 3. Conduct multi-cycle progressively stronger directional impact tests based on the impact direction of each batch of samples for each spectral type; Step 4. After the directional impact test is completed, destructive sampling and precise quantitative detection are carried out according to the segmented regions of each formulation of each batch of samples to obtain the content value of each substance in each segmented region of each formulation of each batch of samples, and the content deviation coefficient of each formulation of each batch of samples in each segmented region is evaluated. Step 5. Based on the content deviation coefficient of each preparation in each segmented region of each batch of samples, analyze the deviation concentration hazard coefficient of each batch of samples, thereby screening each batch of samples with deviation and sending them to the quality management personnel.