A non-destructive testing method based on maltodextrin tablets

Abstract

The present invention discloses a non-destructive testing method for maltodextrin tablets, which relates to the technical field of non-destructive testing of tablets. The non-destructive testing method for maltodextrin tablets comprises the following steps: S1. Prepare tablets: Prepare a plurality of tablets containing maltodextrin with different hardnesses; S2. Test the phosphorescence lifetime of the tablets containing maltodextrin: By using a transient / steady-state fluorescence spectrometer, at an excitation wavelength of 254 nm, use the software supporting the transient / steady-state fluorescence spectrometer to fit the phosphorescence lifetime according to a multi-exponential function, and calculate the average phosphorescence lifetime τ avg ; S3. Detect the afterglow image of the tablets containing maltodextrin; S4. Evaluate the performance indexes of the tablets according to the phosphorescence lifetime and the afterglow image of the tablets; The non-destructive testing method for maltodextrin tablets provided by the present application can non-destructively detect the hardness, humidity, disintegration time limit, and content uniformity of the tablets; It is green, environmentally friendly, safe, and produces no pharmaceutical waste, and has economic value.

Description

Technical Field

[0001] The invention relates to the technology of tablet nondestructive testing, in particular to a nondestructive testing method based on maltodextrin tablets. Background Art

[0002] Tablet quality inspection is a key step in tablet production and is closely related to human health. It has received extensive attention in recent years. The existing tablet quality inspection methods mainly use instruments to detect various indicators such as tablet hardness, water content, disintegration time, content uniformity, etc. These methods will damage the tablets, generate a large amount of pharmaceutical waste, and cause environmental pollution. Large-scale destructive testing leads to reduced tablet utilization and reduced economic efficiency. Non-destructive testing, as a new type of testing method, has received extensive attention in recent years due to its rapidity, safety, and environmental protection. Room temperature phosphorescent materials are materials that respond to stimuli such as pressure, humidity, temperature, gas, and pH. They are often used in light-emitting diode displays, biomedical imaging, rapid detection, anti-counterfeiting, and encryption. After being irradiated by ultraviolet light, room temperature phosphorescent materials have afterglow effects of different intensities. Compared with fluorescent images, the afterglow images of room temperature phosphorescent materials have a larger signal-to-noise ratio during the detection process, which can not only eliminate the interference of scattered light and background fluorescence, but also provide rich information according to different response stimuli.

[0003] In recent years, non-aromatic polymers with luminescent properties have attracted widespread attention due to their advantages such as easy availability, renewability and processing, convenient structural modification, and strong biocompatibility. In the pharmaceutical field, most excipients are derived from non-aromatic polymers. These polymers contain more hydroxyl groups and form strong hydrogen bonds within the molecules, which is conducive to the generation of phosphorescence. Maltodextrin (MD), as a polysaccharide food raw material with a multi-hydroxy structure, can be observed to have an obvious afterglow phenomenon after being irradiated by ultraviolet light, and is a room temperature phosphorescent material. Due to its stable physicochemical properties, difficulty in absorbing moisture, and difficulty in deterioration, it is usually used as a filler in tablets. At present, the quality inspection method of tablets has become mature, but there is still a gap in the non-destructive inspection of tablet quality. We urgently need to find a non-destructive inspection method based on maltodextrin tablets. Summary of the invention

[0004] In view of this, the present invention aims at the deficiencies in the prior art, and its main purpose is to provide a nondestructive testing method based on maltodextrin tablets, which can nondestructively test the characteristics of tablet hardness, humidity, disintegration time, and content uniformity; the nondestructive testing method provided by the present invention can determine whether the tablets are damp and deteriorated during transportation and storage, and has wide application value; the nondestructive testing method provided by the present invention is green, environmentally friendly, safe, does not generate any medicinal waste, and has economic value.

[0005] To achieve the above purpose, the present invention adopts the following technical solutions:

[0006] A non-destructive testing method based on maltodextrin tablets, comprising the following steps:

[0007] S1. Prepare tablets: Prepare multiple tablets containing maltodextrin with different hardnesses, and the hardness of each tablet is uniform;

[0008] S2. Test the phosphorescence lifetime of the tablets containing maltodextrin: Use a transient / steady-state fluorescence spectrometer equipped with a xenon lamp and a microsecond flash lamp. At an excitation wavelength of 240 - 260 nm, use the software supporting the transient / steady-state fluorescence spectrometer to fit the phosphorescence lifetime according to a multi-exponential function, and calculate the average phosphorescence lifetime τ avg ; The phosphorescence lifetime is the decay curve of the monitored emission wavelength under the excitation of the light source;

[0009] S3. Detect the afterglow image of the tablets containing maltodextrin: The afterglow image of the tablets is obtained by taking pictures. Fix a 240 - 260 nm clamp ultraviolet lamp beside the tablets. After irradiating with the ultraviolet lamp for 5 - 15 s, record the afterglow image. Analyze each frame of the video of the afterglow image through video analysis software to capture the afterglow image of the tablets, and quantify the afterglow image by analyzing the average gray value of the image through the "ImageJ" software;

[0010] S4. Evaluate the performance indicators of the tablets according to the phosphorescence lifetime and the afterglow image of the tablets.

[0011] As a preferred solution: The multi-exponential function used for fitting the phosphorescence lifetime in step S2 is: , and calculate the average phosphorescence lifetime τ through the formula ; where: R(t) represents the phosphorescence lifetime, t represents time, τ avg represents different types of phosphorescence lifetimes, including radiative transition lifetime τ1, non-radiative transition lifetime τ2, other form lifetimes τ3, and Bi represents the percentage of different types of phosphorescence lifetimes. i represents different types of phosphorescence lifetimes, including radiative transition lifetime τ1, non-radiative transition lifetime τ2, other form lifetimes τ3, and Bi represents the percentage of different types of phosphorescence lifetimes.

[0012] As a preferred solution: The excitation wavelength in step S2 is 254 nm; In step S3, fix the 254 nm clamp ultraviolet lamp 5 cm away from the surface of the tablets. After irradiating with the ultraviolet lamp for 10 s, record the afterglow image for 5 s.

[0013] As a preferred solution: the performance indicators for evaluating the tablets in step S4 include the humidity detection and evaluation of the tablets: select maltodextrin tablets with a hardness of 100 N for the hygroscopicity experiment. Set 25°C in the biochemical incubator, place the tablets in a desiccator containing saturated salts, prepare four saturated salt solutions of LiCl, K2CO3, KI, and K2SO4, and store them under environmental conditions with relative humidities of 11%, 43%, 69%, and 94% respectively. After 6 hours, take out the tablets and detect the phosphorescence lifetime and afterglow image to evaluate their humidity conditions.

[0014] As a preferred solution: the performance indicators for evaluating the tablets in step S4 include the disintegration time limit detection and evaluation of the tablets: the method for determining the disintegration time limit is the basket method. Take the tablets, use pure water as the medium, keep the temperature at 37 ± 1°C, detect the phosphorescence lifetime and afterglow image of each tablet, and evaluate the disintegration time limit of the tablets.

[0015] As a preferred solution: the performance indicators for evaluating the tablets in step S4 include the mixing uniformity detection and evaluation of the tablets: irradiate the tablets with an ultraviolet lamp, compare the afterglow image of the tablets with the drugs with uneven mixing, analyze the gray value of the afterglow image and calculate the relative standard deviation of the gray value to evaluate the mixing uniformity of the tablets.

[0016] As a preferred solution: the performance indicators for evaluating the tablets in step S4 include the detection and evaluation of the addition ratio of excipients: irradiate the tablets with an ultraviolet lamp, and evaluate the addition ratio of excipients according to the display of the afterglow image of the tablets.

[0017] As a preferred solution: the performance indicators for evaluating the tablets in step S4 include the hardness detection and evaluation of the tablets: detect the phosphorescence lifetime and afterglow image of maltodextrin tablets with different hardnesses and perform gray value analysis to evaluate the hardness of the tablets.

[0018] As a preferred solution: the tablets include 20% - 40% maltodextrin and 60% - 80% polyvinylpyrrolidone K30.

[0019] As a preferred solution: the tablets include 20% - 80% maltodextrin and 20% - 80% andrographis powder.

[0020] Compared with the prior art, the present invention has obvious advantages and beneficial effects. Specifically, as can be seen from the above technical solutions:

[0021] (1) The non-destructive detection method provided by the present invention can non-destructively detect the hardness, humidity, disintegration time limit, and content uniformity of the tablets.

[0022] (2) The non-destructive detection method provided by the present invention can judge whether the tablets are affected by moisture and deteriorated during transportation and storage, and has broad application value.

[0023] (3)The non-destructive testing method provided by the present invention is green, environmentally friendly, safe, and generates no medicinal waste, and has economic value.

[0024] (4)The raw material used in the present invention is maltodextrin, which has a low sweetness, stable properties, and is often used as a medicinal excipient. Moreover, maltodextrins with different glucose equivalents have different intensities of afterglow effects and have potential application values.

[0025] To more clearly elaborate on the structural features and effects of the present invention, the following will be a detailed description thereof in conjunction with the drawings and specific embodiments. Description of the Drawings

[0026] Figure 1 The afterglow images of MCC PH101 under the irradiation of 254nm and 365nm ultraviolet lamps of the present invention;

[0027] Figure 2 The afterglow images of MCC PH102, HPMC, and HPC under the irradiation of 254nm and 365nm ultraviolet lamps of the present invention;

[0028] Figure 3 The afterglow images of HPMCAC, SS, and CMS under the irradiation of 254nm and 365nm ultraviolet lamps of the present invention;

[0029] Figure 4 The afterglow images of PVP K30 and LA under the irradiation of 254nm and 365nm ultraviolet lamps of the present invention;

[0030] Figure 5 The afterglow images of MD under the irradiation of 254nm and 365nm ultraviolet lamps of the present invention;

[0031] Figure 6 The afterglow images of MD tablets with hardnesses of 70N and 100N of the present invention;

[0032] Figure 7 The afterglow images of MD tablets with hardnesses of 130N and 160N of the present invention;

[0033] Figure 8 The fitting phosphorescence lifetime curves of MD tablets with a hardness of 70N of the present invention;

[0034] Figure 9 The fitting phosphorescence lifetime curves of MD tablets with a hardness of 100N of the present invention;

[0035] Figure 10 The fitting phosphorescence lifetime curves of MD tablets with a hardness of 130N of the present invention;

[0036] Figure 11Phosphorescence lifetime curve fitting for the 160N-MD tablets of the present invention;

[0037] Figure 12 Moisture absorption of MD tablets under different humidity conditions of the present invention;

[0038] Figure 13 Afterglow images of MD tablets stored in saturated K2SO4 and KI solutions for 6 h and irradiated with a 254 nm ultraviolet lamp of the present invention;

[0039] Figure 14 Afterglow images of MD tablets stored in saturated K2CO3 and LiCl solutions for 6 h and irradiated with a 254 nm ultraviolet lamp of the present invention;

[0040] Figure 15 Relationship between the average gray value and the number of afterglow frames of MD tablets under different humidity conditions of the present invention;

[0041] Figure 16 Relationship between the initial gray value and the number of afterglow frames of MD tablets under different humidity conditions of the present invention;

[0042] Figure 17 Phosphorescence lifetime curve fitting for MD tablets under environmental conditions of 25 °C, saturated K2SO4, and 6 h of the present invention;

[0043] Figure 18 Phosphorescence lifetime curve fitting for MD tablets under environmental conditions of 25 °C, saturated KI, and 6 h of the present invention;

[0044] Figure 19 Phosphorescence lifetime curve fitting for MD tablets under environmental conditions of 25 °C, saturated K2CO3, and 6 h of the present invention;

[0045] Figure 20 Phosphorescence lifetime curve fitting for MD tablets under environmental conditions of 25 °C, saturated LiCl, and 6 h of the present invention;

[0046] Figure 21 Relationship between the hardness and disintegration time limit of MD tablets of the present invention;

[0047] Figure 22 Afterglow images of MD-AH tablets in different ratios of the present invention;

[0048] Figure 23 Afterglow images of MD-PVP tablets in different ratios of the present invention;

[0049] Figure 24 Afterglow images of PVP-MD 7:3 tablets and unevenly mixed tablets of the present invention. Detailed implementation manners

[0050] The present invention is as Figure 1As shown in FIGS. 1 to 24, a non-destructive testing method for maltodextrin tablets includes the following steps:

[0051] S1. Prepare tablets: Prepare multiple tablets containing maltodextrin with different hardnesses, and the hardness of each tablet is uniform.

[0052] The maltodextrin is pressed in single-punch mode by a multi-functional tablet press (manufacturer: ERWEKA, Germany; model: TR-D8). Adjust the instrument parameters to press the tablets into different hardnesses (70N, 100N, 130N, 160N), with a tablet weight of 300 mg. The hardness of each tablet is detected by a tablet hardness tester to ensure that the tablet hardness is uniform under each parameter condition. Before pressing each sample each time, a blank magnesium stearate tablet needs to be pressed to avoid sticking and lubrication.

[0053] S2. Test the phosphorescence lifetime of the tablets containing maltodextrin: Use a transient / steady-state fluorescence spectrometer equipped with a xenon lamp and a microsecond flash lamp. At an excitation wavelength of 240 - 260 nm, use the software supporting the transient / steady-state fluorescence spectrometer to fit the phosphorescence lifetime according to the multi-exponential function, and calculate the average phosphorescence lifetime (τ avg ); The phosphorescence lifetime is the decay curve of the monitored emission wavelength under the excitation of the light source.

[0054] S3. Detect the afterglow image of the tablets containing maltodextrin: The afterglow image of the tablets is obtained by taking pictures. Fix a 240 - 260 nm clamp ultraviolet lamp beside the tablets. After irradiating with the ultraviolet lamp for 5 - 15 s, record the afterglow image. The afterglow image is analyzed frame by frame through video analysis software to capture the afterglow image of the tablets, and the average gray value of the image is analyzed by the "ImageJ" software to quantify the afterglow image.

[0055] S4. Evaluate the performance indicators of the tablets according to the phosphorescence lifetime and afterglow image of the tablets.

[0056] The multi-exponential function used for fitting the phosphorescence lifetime in step S2 is: , and calculate the average phosphorescence lifetime τ through the formula avg ; where: R(t) represents the phosphorescence lifetime, t represents time, τ i represents different types of phosphorescence lifetimes, including radiative transition lifetime τ1, non-radiative transition lifetime τ2, and other form lifetimes τ3, and Bi represents the percentage of different types of phosphorescence lifetimes.

[0057] The excitation wavelength in step S2 is 254 nm; in step S3, fix the 254 nm clamp ultraviolet lamp 5 cm away from the tablet surface. After irradiating with the ultraviolet lamp for 10 s, record the afterglow image for 5 s.

[0058] In step S4, the performance indicators for evaluating the tablets include moisture detection and evaluation of the tablets: Select maltodextrin tablets with a hardness of 100 N for the hygroscopicity experiment. The experiment is carried out according to the hygroscopicity guiding principle in General Principles of the Fourth Part of Chinese Pharmacopoeia (2020 Edition). Set the temperature at 25 °C in a biochemical incubator, place the tablets in a desiccator containing saturated salts, prepare four saturated salt solutions of LiCl, K2CO3, KI, and K2SO4, and store them in environmental conditions with relative humidity of 11%, 43%, 69%, and 94% respectively; After 6 hours, take out the tablets and detect the phosphorescence lifetime and afterglow image to evaluate their moisture condition.

[0059] In step S4, the performance indicators for evaluating the tablets include the detection and evaluation of the disintegration time limit of the tablets: Conduct according to the requirements for the disintegration time limit of tablets in General Principles of the Fourth Part of Chinese Pharmacopoeia (2020 Edition); The method for determining the disintegration time limit is the basket method. Take 6 tablets, select pure water as the medium, and keep the temperature at 37 ± 1 °C. Start the basket to vibrate up and down, adjust the position of the basket so that when it drops to the lowest point, the sieve is 25 mm away from the bottom of the beaker, and adjust the water level height so that when the basket rises to the highest point, the sieve is 15 mm below the water surface; Detect the phosphorescence lifetime and afterglow image of each tablet to evaluate the disintegration time limit of the tablets.

[0060] In step S4, the performance indicators for evaluating the tablets include the detection and evaluation of the mixing uniformity of the tablets: Mix 70% polyvinylpyrrolidone (PVP K30) with 30% MD and then press into tablets. The tablets are irradiated with an ultraviolet lamp and compared with the drug with uneven mixing. Analyze the gray value of the afterglow image and calculate the relative standard deviation of the gray value to evaluate the mixing uniformity of the tablets.

[0061] In step S4, the performance indicators for evaluating the tablets include the detection and evaluation of the addition ratio of excipients: Mix MD with the non-afterglow Chinese medicine powder Andrographis paniculata (AH) in a ratio of 8:2 and mix with the excipient PVP in a ratio of 3:7 and then press into tablets; The tablets are irradiated with an ultraviolet lamp, and according to the display of the afterglow image of the tablets, evaluate the addition ratio of the excipients.

[0062] In step S4, the performance indicators for evaluating the tablets include the detection and evaluation of the hardness of the tablets: Detect the phosphorescence lifetime and afterglow image of maltodextrin tablets with different hardnesses and conduct gray value analysis to evaluate the hardness of the tablets.

[0063] The tablets contain 20%-40% maltodextrin and 60%-80% polyvinylpyrrolidone K30 to evaluate the excipient specificity and the mixing uniformity of the tablets.

[0064] The tablets contain 20%-80% maltodextrin and 20%-80% Andrographis paniculata powder to evaluate the excipient specificity.

[0065] Maltodextrin: A polysaccharide food raw material, used as a filler in tablets. Since maltodextrin is a room-temperature phosphorescent material with an afterglow effect, it serves as the main component for non-destructive tablet detection.

[0066] Polyvinylpyrrolidone K30: A non-functional excipient, used as a filler in tablets. Due to its lack of afterglow effect, it serves as a filler component for non-destructive tablet detection.

[0067] Andrographis paniculata powder: A spray-dried powder, brownish in color. Due to its lack of afterglow effect, it serves as a detection component for the specific addition ratio of MD excipients.

[0068] Example 1

[0069] Take microcrystalline cellulose PH101 (MCC PH101), microcrystalline cellulose PH102 (MCC PH102), hydroxypropyl methylcellulose (HPMC), hydroxypropyl cellulose (HPC), hypromellose acetate succinate (HPMCAC), soluble starch (SS), sodium carboxymethyl starch (CMS), polyvinylpyrrolidone K30 (PVP K30), lactose (LA), and maltodextrin (MD) powders. Fix a 365nm clamp ultraviolet lamp 5cm away from the powder surface, turn on the ultraviolet lamp, irradiate the surface of each powder for 10s, remove the light, and record the afterglow image for 5s.

[0070] Example 2

[0071] Take microcrystalline cellulose PH101, microcrystalline cellulose PH102, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hypromellose acetate succinate, soluble starch, sodium carboxymethyl starch, polyvinylpyrrolidone K30, lactose, and maltodextrin powders. Fix a 254nm clamp ultraviolet lamp 5cm away from the powder surface, turn on the ultraviolet lamp, irradiate the surface of each powder for 10s, remove the light, and record the afterglow image for 5s.

[0072] Example 3

[0073] Mix MD with the non-afterglow traditional Chinese medicine powder Andrographis paniculata (AH) in the ratios of 0:10, 2:8, 4:6, 6:4, 8:2, 10:0, and mix with the non-functional excipient PVP in the ratios of 0:10, 2:8, 4:6, and then press into tablets. All tablets are irradiated with an ultraviolet lamp, and according to the display of the afterglow images of the tablets, evaluate the specificity of the excipients under various substances.

[0074] Example 4

[0075] Press tablets after mixing the non-afterglow effect excipient PVP and MD in a mass ratio of 8:2. By observing the afterglow image, judge the uniformity of the mixed tablets.

[0076] Comparative Example 1

[0077] To further illustrate the beneficial effects of the present invention, first, after various pharmaceutical excipient powders are irradiated with an ultraviolet lamp, it is explored whether there is an afterglow effect. The afterglow shooting method in this experiment is the same as that in Example 1. The difference from Example 1 is that different pharmaceutical excipient powders are used and irradiated with a 365 nm ultraviolet lamp.

[0078] Comparative Example 2

[0079] To further illustrate the beneficial effects of the present invention, first, after various pharmaceutical excipient powders are irradiated with ultraviolet lamps of different wavelengths, the optimal ultraviolet wavelength for the afterglow effect is explored. The wavelengths used in this experiment and Example 2 are both 254 nm, and the afterglow shooting methods are the same. The difference from Example 2 is that various pharmaceutical excipient powders are used.

[0080] Comparative Example 3

[0081] To further illustrate the beneficial results of the present invention, in this experiment, the contents of PVP and MD used are different from those in Example 3. The mixing uniformity is judged by observing the afterglow images of the tablets, and the remaining steps are the same as those in Example 3.

[0082] Effect Example

[0083] Figures 1 - 5 And Table 1 below shows the results of Example 1 and Example 2. It can be seen that: MCC PH101, MCC PH102, HPMCAC, SS, and CMS have an afterglow phenomenon with a microsecond-level duration at 254 nm, while MD has an afterglow phenomenon with a millisecond-level duration at 254 nm, and the remaining pharmaceutical excipients have no afterglow effect at 254 nm. MCC PH101 has an afterglow phenomenon with a microsecond-level duration at 365 nm, while the remaining pharmaceutical excipients have no afterglow effect at 365 nm. The above results show that the afterglow effect of MD is the most obvious under the irradiation of a 254 nm ultraviolet lamp. Therefore, MD is selected as the material for non-destructive detection of afterglow visualization.

[0084] MD is pressed into tablets with different hardnesses by a multi-functional tablet press, detected by a hardness tester, and the afterglow images of MD tablets with different hardnesses are detected. The results are as Figure 6 、 Figure 7 shown.

[0085] Table 1: Afterglow duration of each pharmaceutical excipient

[0086]

[0087] In Table 1, the microsecond level and the millisecond level both represent the length of the afterglow effect of each sample, and the "-" symbol represents no afterglow effect.

[0088] The afterglow image results of maltodextrin tablets at different hardness levels show that the brightness and afterglow duration of the afterglow images of each tablet are similar and cannot be directly judged by the naked eye.

[0089] In this experiment, a transient / steady-state phosphorescence spectrometer was used to measure the phosphorescence lifetimes of each tablet. The phosphorescence lifetime results, multi-exponential function fitting phosphorescence lifetimes, and average phosphorescence lifetimes (τ avg ) results are as Figures 8 to 11 shown in

[0090] Table 2: Phosphorescence lifetime fitting curves of MD tablets with different hardness

[0091]

[0092] Phosphorescence lifetime calculation formula: ;

[0093] Average phosphorescence lifetime calculation formula: ;

[0094] The results in Table 2 show that for maltodextrin tablets with hardness levels of 70 N, 100 N, 130 N, and 160 N, the average phosphorescence lifetimes are 65.1747 ms, 67.1192 ms, 67.8409 ms, and 67.9765 ms respectively. The average phosphorescence lifetime is related to the hardness of the tablet and increases with the increase in tablet hardness. Therefore, the hardness of the tablet can be detected by measuring the average phosphorescence lifetime of the tablet.

[0095] The hygroscopicity experiment was carried out using maltodextrin tablets with a hardness of 100 N. Four environmental conditions with relative humidities of 11%, 43%, 69%, and 94% were set respectively, and the saturated salt solutions were K2SO4, KI, K2CO3, and LiCl. The hygroscopicity of the tablets was measured every 1 hour. The hygroscopicity is as Figure 12 shown.

[0096] It can be seen from Figure 12 that the saturated potassium sulfate solution has the highest relative humidity and the strongest hygroscopicity, with a hygroscopic rate of 9.6% in 6 hours; the hygroscopic rates of the saturated potassium iodide solution and the saturated potassium carbonate solution in 6 hours are 3.93% and 1.69% respectively; while the saturated lithium chloride solution has the lowest relative humidity, and the tablets lose weight under low relative humidity conditions, with a weight loss rate of 0.43%.

[0097] In this experiment, the tablets were taken out after 6 hours of moisture absorption, and the afterglow images of the tablets were detected. The experimental results are as Figure 13 , Figure 14 shown.

[0098] It can be seen from Figure 13 , Figure 14It can be seen that for the tablets stored in a saturated potassium sulfate solution, the moisture absorption rate of the tablets is too high, and the afterglow effect is significantly weaker than that of other tablets. However, it is difficult to quantitatively measure the brightness and duration of the afterglow with the naked eye. Therefore, this experiment proposes a new method to analyze the afterglow images of the tablets. The captured afterglow videos are imported into video editing software for processing, and the afterglow images are exported frame by frame, and the average gray value of each frame of the afterglow image is analyzed. The average gray value can quantify the brightness of the afterglow image to evaluate the strength of the afterglow image. The Image software is used to analyze each frame of the afterglow image. When the afterglow image cannot be observed, the number of afterglow frames and the average gray value are measured. Therefore, the length of the afterglow time is evaluated by the number of afterglow frames. The results of the average gray value, the initial gray value, and the number of afterglow frames are as Figure 15 , Figure 16 shown.

[0099] From Figure 15 , Figure 16 it can be seen that the relative humidity of the saturated K2SO4 solution is the highest, the afterglow effect is the weakest, the initial gray value is 0.192, and only about 7 frames of afterglow images are captured; the relative humidity of the saturated KI and K2CO3 solutions is the second, the initial gray values are 0.335 and 0.381 respectively, and 15 and 23 frames of afterglow images appear; the relative humidity of the saturated LiCl is the lowest, its afterglow effect is the strongest, the initial gray value is 0.520, and there are 23 frames of afterglow images.

[0100] The experiment was verified by detecting the phosphorescence lifetime of the MD tablets under various humidity conditions. The experimental results are shown in Table 3 and Figures 17 - 20 shown.

[0101] Table 3: Phosphorescence lifetime fitting curves of MD tablets in different saturated salt solutions

[0102]

[0103] From Figures 17 - 20 and the verification results of the phosphorescence lifetime of the tablets in Table 3, it can be seen that the average phosphorescence lifetimes of the tablets stored in the saturated K2SO4, KI, K2CO3, and LiCl solutions are 66.4049 ms, 78.0086 ms, 84.7998 ms, and 86.1494 ms respectively. The phosphorescence lifetime decreases with the increase of the tablet humidity. The greater the humidity, the shorter the phosphorescence lifetime and the weaker the afterglow effect, which is consistent with the results analyzed by the above gray value and the number of afterglow frames. Therefore, the moisture absorption of the tablets can be judged by the phosphorescence lifetime.

[0104] In this experiment, the disintegration time limit of the tablets was measured, and the results are as Figure 21 shown.

[0105] From Figure 21It can be seen that for MD tablets with hardness of 70N, 100N, 130N, and 160N, the disintegration times are 569±6s, 579±6s, 582±10s, and 606±9s respectively. The trend of the disintegration time is consistent with the tablet hardness. The greater the hardness, the longer the disintegration time. Therefore, the disintegration time of tablets can be evaluated by measuring the phosphorescence lifetime and afterglow effect of the tablets.

[0106] Compared with Example 3, in this experiment, tablets with MD-AH ratios of 0:10, 2:8, 4:6, 6:4, 8:2, and 10:0 were prepared, and at the same time, tablets with MD-PVP ratios of 0:10, 2:8, 3:7, 4:6, and 10:0 were prepared. After irradiation with an ultraviolet lamp, the afterglow images of the tablets were observed, and the results are as Figure 22 、 Figure 23 shown.

[0107] From Figure 22 、 Figure 23 it is known that the experiment first proved that when the MD-AH and MD-PVP ratios are 0:10, pure AH and PVP have no afterglow effect. When the MD-AH ratio is 8:2, a faint but complete tablet contour can be observed in the afterglow image; when the MD-PVP ratio is 2:8, only a partial tablet contour can be observed in the afterglow image of the tablet, rather than a complete tablet. When the MD-PVP ratio is 3:7, the contour of the tablet afterglow image is obvious. The experimental results show that different traditional Chinese medicines and excipients have different sensitivities to MD. The mixing ratio of each sample with MD determines the excipient specificity of the sample. The specific ratio of MD-AH is 8:2, and the specific ratio of MD-PVP is 3:7.

[0108] In the experiment, the non-functional excipient PVP K30 without afterglow effect was mixed with MD at a specific ratio of 7:3 and then pressed into tablets. The content uniformity was measured and compared with tablets with uneven mixing. The initial gray value, standard deviation, relative standard deviation, and afterglow image results of the tablets are as Figure 24 、Table 4 shows.

[0109] Table 4: Initial gray value, standard deviation, and relative standard deviation of PVP-MD-7:3 tablets

[0110]

[0111] The experiment represented the uniformity of tablet mixing by analyzing the initial gray value, standard deviation, and relative standard deviation of the afterglow images of the tablets. The magnitude of the initial gray value represented the intensity of the afterglow image. The smaller the relative standard deviation, the more uniform the mixing. As shown in Table 4, the initial gray values of the tablets with a PVP-MD ratio of 7:3 were 20.402, 19.964, and 19.131, and the relative standard deviations were 15.00%, 20.38%, and 15.28%, respectively. The results showed that the order of the mixing uniformity of the three tablets was: (1) > (3) > (2). Due to the uneven distribution of MD, there was an afterglow effect in the parts of the tablets with uneven mixing, and the initial gray values were 29.875 and 36.851, and the relative standard deviations were 88.87% and 36.70%, respectively, which were much larger than the relative standard deviations of other gray values. The order of the mixing uniformity was: (5) > (4). From Figure 24 It can be seen that the integrity of the tablets can be directly observed through the afterglow images in the experiment. The tablets with uniform mixing have easily observable tablet contours, while the tablets with uneven mixing are non-integral tablets. The mixing uniformity of the tablets can be evaluated by the relative standard deviation of the gray values of the afterglow images.

[0112] The key design points of the present invention are as follows:

[0113] (1) The non-destructive testing method provided by the present invention can non-destructively detect the hardness, humidity, disintegration time limit, and content uniformity of the tablets.

[0114] (2) The non-destructive testing method provided by the present invention can determine whether the tablets are affected by moisture and deteriorated during transportation and storage, and has wide application value.

[0115] (3) The non-destructive testing method provided by the present invention is green, environmentally friendly, safe, and does not produce medicinal waste, and has economic value.

[0116] (4) The raw material used in the present invention is maltodextrin, which has a low sweetness, stable properties, and is often used as a pharmaceutical excipient. Maltodextrins with different glucose equivalents have different intensities of afterglow effects and have potential application value.

[0117] The above are only the preferred embodiments of the present invention, and do not impose any limitation on the technical scope of the present invention. Therefore, any minor modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of the present invention still fall within the scope of the technical solution of the present invention.

Claims

1. A non-destructive testing method for maltodextrin tablets, characterized in that: It includes the following steps: S1. Prepare tablets: Prepare multiple tablets containing maltodextrin with different hardnesses, and the hardness of each tablet is uniform; S2. Test the phosphorescence lifetime of the maltodextrin-containing tablets: Use a transient / steady-state fluorescence spectrometer equipped with a xenon lamp and a microsecond flash lamp. At an excitation wavelength of 240 - 260 nm, use the software supporting the transient / steady-state fluorescence spectrometer to fit the phosphorescence lifetime according to a multi-exponential function, and calculate the average phosphorescence lifetime τavg based on the phosphorescence lifetime; The phosphorescence lifetime is the decay curve of the monitored emission wavelength under the excitation of the light source; S3. Detect the afterglow image of the maltodextrin-containing tablets: The afterglow image of the tablets is obtained by taking pictures. Fix a 240 - 260 nm clamp ultraviolet lamp beside the tablets. After irradiating with the ultraviolet lamp for 5 - 15 s, record the afterglow image. The afterglow image is analyzed frame by frame through video analysis software to capture the afterglow image of the tablets, and the average gray value of the image is analyzed by "ImageJ" software to quantify the afterglow image; The afterglow effect of maltodextrin is the most obvious under the irradiation of a 254 nm ultraviolet lamp. Maltodextrin is used as a material for non-destructive detection of afterglow visualization; S4. Evaluate the performance indicators of the tablets according to the phosphorescence lifetime and afterglow image of the tablets.

2. The non-destructive testing method of a maltodextrin tablet according to claim 1, characterized in that: The multi-exponential function used for fitting the phosphorescence lifetime in the step S2 is as follows: , and the average phosphorescence lifetime τavg is calculated by the formula ; where: R(t) represents the phosphorescence lifetime, t represents time, τi represents different types of phosphorescence lifetimes, including the radiative transition lifetime τ1, the non-radiative transition lifetime τ2, and other forms of lifetime τ3, and Bi represents the percentage of different types of phosphorescence lifetimes.

3. The non-destructive testing method for a maltodextrin tablet according to claim 1, characterized in that: The excitation wavelength in step S2 is 254 nm; In step S3, fix the 254 nm clamp ultraviolet lamp 5 cm away from the tablet surface. After irradiating with the ultraviolet lamp for 10 s, record the afterglow image for 5 s.

4. The non-destructive testing method for a maltodextrin tablet according to claim 1, characterized in that: The performance indicators for evaluating the tablets in step S4 include the detection and evaluation of the humidity of the tablets: Select maltodextrin tablets with a hardness of 100 N for the hygroscopicity experiment. Set 25℃ in a biochemical incubator, place the tablets in a desiccator containing saturated salts, prepare four saturated salt solutions of LiCl, K2CO3, KI, and K2SO4, and set the environmental conditions with relative humidities of 11%, 43%, 69%, and 94% for storage respectively; After 6 hours, take out the tablets and detect the phosphorescence lifetime and afterglow image to evaluate their humidity conditions.

5. A non-destructive testing method for a maltodextrin tablet according to claim 1, characterized in that: The performance indicators for evaluating the tablets in step S4 include the detection and evaluation of the disintegration time limit of the tablets: The method for determining the disintegration time limit is the basket method. Take the tablets, select pure water as the medium, keep the temperature at 37 ± 1℃, detect the phosphorescence lifetime and afterglow image of each tablet, and evaluate the disintegration time limit of the tablets.

6. The non-destructive testing method for a maltodextrin tablet according to claim 1, characterized in that: The performance indicators for evaluating the tablets in step S4 include the detection and evaluation of the mixing uniformity of the tablets: Irradiate the tablets with an ultraviolet lamp. According to the brightness and distribution of the afterglow image of the tablets, compare with the drugs with uneven mixing, analyze the gray value of the afterglow image and calculate the relative standard deviation of the gray value to evaluate the mixing uniformity of the tablets.

7. A non-destructive testing method for a maltodextrin tablet according to claim 1, characterized in that: The performance indicators for evaluating the tablets in step S4 include the detection and evaluation of the addition ratio of excipients: Irradiate the tablets with an ultraviolet lamp. According to the display of the afterglow image of the tablets, evaluate the addition ratio of excipients.

8. A non-destructive testing method for a maltodextrin tablet according to claim 1, characterized in that: The performance indicators for evaluating the tablets in step S4 include the detection and evaluation of the hardness of the tablets: Detect the phosphorescence lifetime and afterglow image of maltodextrin tablets with different hardnesses and conduct gray value analysis to evaluate the hardness of the tablets.

9. A non-destructive testing method for a maltodextrin tablet according to claim 1, characterized in that: The tablets include 20% - 40% of maltodextrin and 60% - 80% of polyvinylpyrrolidone K30.

10. A non-destructive testing method for a maltodextrin tablet according to claim 1, characterized in that: The tablet comprises 20%-80% maltodextrin and 20%-80% andrographis powder.

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