Capsule medicine solubility detection device

Abstract

The present application relates to the technical field of medicine capsule detection, and particularly to a capsule medicine solubility detection device, which comprises an obstacle module, a liquid extraction module, a vibrator, a constant temperature controller, a temperature sensor, a visual sensor and a central control assembly. The present application analyzes each acid real-time image, and according to the analysis result, makes a first determination on the target capsule medicine to determine whether to start a disturbance mode, makes a second determination on the target capsule medicine based on the disturbance mode to obtain a second determination result, determines whether to make a second type detection on the target capsule medicine according to the second determination result, receives each alkaline real-time image monitored by the visual sensor in real time during the second type detection, analyzes each alkaline real-time image to make a third determination on the target capsule medicine, and based on the third determination result, the central control assembly outputs a final detection report of the target capsule medicine in combination with the first determination result and the second determination result.

Description

Technical Field

[0001] This invention relates to the field of pharmaceutical capsule testing technology, and in particular to a device for testing the solubility of capsule pharmaceuticals. Background Technology

[0002] Enteric-coated capsules have wide applications in the medical field. Their unique dissolution mechanism allows drugs to be accurately delivered to the intestines, thereby achieving optimal efficacy and reducing irritation to the gastric mucosa. However, if enteric-coated capsules are used without undergoing solubility testing, they may dissolve prematurely in the stomach due to the action of gastric acid, causing the drug to be released prematurely. This results in the drug failing to reach the expected release rate and concentration in the intestines, thus affecting its efficacy. Furthermore, some drug components in enteric-coated capsules are irritating to the gastric mucosa. If the drug dissolves and is released in the stomach, it will directly contact the gastric mucosa, causing damage and potentially leading to adverse reactions such as nausea, vomiting, and stomach pain. It may even lead to serious consequences such as gastric ulcers and bleeding. Therefore, to ensure the efficacy and safety of enteric-coated capsules, solubility testing must be performed before use to ensure their integrity.

[0003] Chinese patent application publication number CN112557610A discloses a biological capsule solubility detection device, comprising: a mounting frame for mounting the entire device; a rotating detection component mounted on the mounting frame and powered for rotating detection; a dispensing component mounted on the mounting frame and dispensing material by sliding; and a moving component mounted on the mounting frame and moving by sliding, the moving component cooperating with the dispensing component.

[0004] Therefore, current capsule drug solubility testing devices cannot effectively reflect the actual solubility of capsules, and thus cannot accurately detect the solubility of drug capsules. Summary of the Invention

[0005] Therefore, the purpose of this invention is to provide a capsule drug solubility testing device to overcome the problem that current capsule drug solubility testing devices cannot effectively reflect the actual solubility of capsules, thus failing to accurately detect the solubility of drug capsules.

[0006] To achieve the above objectives, the present invention provides a capsule drug solubility detection device, comprising:

[0007] The simulation chamber is the target detection area for the target capsule drug, and the target detection area contains a target simulation liquid.

[0008] The target simulation solution includes: a first target simulation solution and a second target simulation solution; the first target simulation solution is acidic, and the second target simulation solution is alkaline.

[0009] A stirring module includes several stirrers; each stirrer is evenly arranged inside the simulation chamber; the stirring module stirs the target simulated liquid in the simulation chamber 1 in sections at a preset initial stirring rate to form a simulated flow state.

[0010] An obstacle module includes several simulated disturbance rods; each simulated disturbance rod is configured in a bent shape and is uniformly and fixedly disposed inside the simulated cavity; the obstacle module is used to provide disturbance.

[0011] A liquid extraction module, comprising several liquid extraction pumps, is used to replace the target simulation liquid in the simulation chamber;

[0012] A vibrator is connected to the simulated cavity, and the vibrator vibrates the simulated cavity at a preset initial vibration frequency to form a simulated peristaltic state;

[0013] A thermostat is located on one side of the simulation chamber to control the target simulation liquid to maintain a constant temperature.

[0014] A temperature sensor, which is installed inside the simulation chamber, is used to detect the temperature of the target simulated liquid in real time;

[0015] A visual sensor, which is mounted on the simulation cavity, is used to monitor the formed target simulation scene in real time;

[0016] The central control assembly performs a first-class detection on the target capsule drug when the simulated cavity contains the first target simulated liquid. During the first-class detection, it periodically acquires real-time images of various acidic substances monitored by the visual sensor at preset initial acquisition intervals. It analyzes these real-time acidic images and makes a first judgment on the target capsule drug based on the analysis results. Based on the first judgment result, it determines whether to activate a disturbance mode and performs a second judgment on the target capsule drug based on the disturbance mode to obtain a second judgment result. Based on the second judgment result, it determines whether to perform a second-class detection on the target capsule drug. During the second-class detection, it receives real-time images of various alkaline substances monitored by the visual sensor. It analyzes these real-time alkaline images and makes a third judgment on the target capsule drug based on the analysis results. Based on the three judgment results, the central control assembly combines the first and second judgment results to output a final detection report for the target capsule drug.

[0017] Furthermore, the central control assembly includes: a type of detection unit;

[0018] The detection unit periodically acquires real-time acidic images of the target capsule drug at the initial acquisition interval, determines whether the outer surface of the target capsule drug is intact based on the real-time acidic images, and determines to activate the perturbation mode if the outer surface of the target capsule drug is intact; determines that the target capsule drug is unqualified if the outer surface of the target capsule drug is incomplete; and performs a secondary determination on the target capsule drug based on the perturbation mode.

[0019] Furthermore, the central control assembly also includes: a second-class detection unit;

[0020] The second-class detection unit is used to perform segmented detection of the second-class detection process of the target capsule drug according to the dissolution form of the target capsule drug, perform single analysis of the single dissolution process of each segment, and make three judgments based on the single analysis results to obtain the three judgment results.

[0021] Furthermore, the central control assembly also includes: an overall analysis unit and an output unit;

[0022] The overall analysis unit determines that the target capsule drug is ultimately qualified when both the Class I and Class II test results are qualified, and determines the qualification level of the target capsule drug based on the Class II test results when the target capsule drug is ultimately qualified.

[0023] The output unit outputs the final test report of the target capsule drug according to the pass level.

[0024] Furthermore, the detection unit includes: a primary judgment subunit and a verification subunit;

[0025] The first judgment subunit starts timing based on the start of the first type of detection, and ends timing when the timing duration reaches the preset first type of standard duration, so as to obtain the first type of detection duration;

[0026] When the timer ends, a real-time verification image is acquired at that moment. Based on the real-time verification image, it is determined whether the outer surface of the target capsule drug is intact. Based on the condition of the outer surface, it is determined whether to activate the correction mode.

[0027] The verification subunit, when the correction mode is enabled, corrects the initial acquisition interval to obtain the actual acquisition interval.

[0028] Furthermore, the detection unit further includes: a disturbance detection subunit;

[0029] The disturbance detection subunit is used to linearly increase the initial stirring rate and the initial vibration frequency by a preset growth ratio according to the disturbance mode, and to acquire real-time images of each disturbance monitored by the visual sensor during the linear growth process.

[0030] Furthermore, the detection unit further includes a secondary judgment subunit;

[0031] The secondary judgment subunit determines whether the outer surface of the target capsule drug is intact based on any real-time disturbed image. If the outer surface of the target capsule drug is intact, it determines that a second-class test should be performed; if the outer surface of the target capsule drug is incomplete, it determines that the target capsule drug is unqualified.

[0032] Furthermore, the second type of detection unit includes: a first detection subunit and a second detection subunit;

[0033] The first detection subunit, for any alkaline real-time image, if the target capsule drug is found to be ruptured in the alkaline real-time image, then the first detection subunit starts timing until the target capsule shell stops dissolving, and then stops timing to obtain the actual shell dissolution time; a first dissolution score is determined based on the actual shell dissolution time and the final shell dissolution state;

[0034] The second detection subunit, for any alkaline real-time image, if the target capsule shows leakage of the drug, starts timing until the substance inside the target capsule is completely dissolved, and then stops timing to obtain the actual dissolution time of the internal substance; a second dissolution score is determined based on the actual dissolution time of the internal substance.

[0035] Furthermore, the second type of detection unit also includes: a three-stage decision subunit;

[0036] The three-stage determination subunit is used to determine the three-stage determination results based on the first dissolution score and the second dissolution score.

[0037] Wherein, if the first dissolution score is less than or equal to 0, the three-judgment subunit determines that the target capsule drug is unqualified; if the second dissolution score is less than or equal to 0, the three-judgment subunit determines that the target capsule drug is unqualified; if both the first dissolution score and the second dissolution score are greater than 0, the three-judgment subunit determines that the target capsule drug is qualified.

[0038] Furthermore, the overall analysis unit includes: a level judgment subunit;

[0039] The grade determination subunit calculates the overall dissolution score based on the first dissolution score and the second dissolution score, and determines the qualified grade based on the overall dissolution score.

[0040] Compared with existing technologies, the advantages of this invention are as follows: by using a first target simulated liquid (simulated gastric juice) and a second target simulated liquid (simulated intestinal juice), the digestive environments of the stomach and intestines can be simulated respectively; this helps to more accurately evaluate the performance of the capsule at different digestive stages; the use of a thermostat and a temperature sensor ensures that the simulated liquid maintains a constant temperature throughout the detection process, thereby reducing the impact of temperature fluctuations on the experimental results; the combined use of a stirring module and a vibrator simulates mechanical movements within the human body, such as peristalsis of the stomach and churning of the intestines, which helps to more realistically simulate the behavior of the capsule during digestion; the setting of an obstacle module (simulated disturbance rod) can simulate the folds of the stomach and intestinal walls, providing additional disturbance to the capsule, thereby more accurately simulating the movement and dissolution of the capsule during actual digestion; and the use of a visual sensor allows for real-time monitoring of the capsule's dissolution. The process of dissolving the capsules is analyzed by the central control unit, improving the accuracy and efficiency of detection. The central control unit can decide whether to activate the disturbance mode based on the preliminary judgment results and whether to perform Class II detection based on the secondary judgment results. This process design increases the flexibility and adaptability of the device. The simulation chamber and obstacle module are made of transparent, flexible, and acid- and alkali-resistant materials, which not only facilitates the observation of the capsule dissolution process but also adapts to different chemical environments, ensuring the stability and durability of the device. Through primary, secondary, and tertiary judgments, and combining the detection results under different conditions, the central control unit can output a more reliable final detection report, providing strong support for drug quality control and evaluation. It provides an efficient, accurate, and reliable experimental platform for the detection of enteric-coated capsules, helping to ensure the safety and efficacy of enteric-coated capsules in the market.

[0041] By periodically acquiring real-time acidic images of the target capsule, the detection unit can accurately determine the integrity of the capsule's outer surface, which is crucial for assessing the capsule's stability in the acidic environment of the stomach. Based on the detection results of the capsule's outer surface integrity, it can intelligently decide whether to activate the perturbation mode, which helps to more realistically simulate the mechanical effects of the capsule in the stomach, thereby improving the accuracy of the detection. The detection unit times the first-class detection duration, and stops timing when the first-class detection duration reaches the preset first-class standard duration, acquiring a real-time verification image at the moment of stopping the timing, thereby determining the integrity of the target capsule's outer surface and deciding whether to directly activate the perturbation mode or correct the initial acquisition interval. This allows for dynamic management of the detection process and avoidance of errors. The absence of excessively long detection cycles prevents the timing of the initial dissolution of target capsule drugs, while ensuring that the detection period is neither too long nor too short, thus improving detection efficiency. It allows for adjustments to the detection strategy based on the actual performance of the capsules; real-time correction of the initial acquisition interval yields the actual acquisition interval, which helps to more accurately capture key changes in the capsule during digestion; it provides a basis for subsequent testing; it enables more accurate determination of capsule quality, reducing the possibility of misjudgments and missed detections; through intelligent adjustment of the acquisition interval and detection duration, it optimizes resource utilization, reducing unnecessary detection time and resource consumption; it improves the accuracy, efficiency, and reliability of capsule drug detection, while optimizing the use of detection resources, providing strong technical support for drug quality control.

[0042] By linearly increasing the initial stirring rate and vibration frequency in the perturbation mode, the perturbation detection subunit can more realistically simulate the mechanical effects experienced by the capsule during human digestion, thereby improving the simulation accuracy. Real-time acquisition of perturbation images during the linear increase process allows for continuous monitoring of changes in the capsule's outer surface under perturbation, providing detailed data support for subsequent judgment. The secondary judgment subunit analyzes each real-time perturbation image to determine the integrity of the capsule's outer surface, helping to promptly identify potential problems during simulated digestion. The combined use of the perturbation detection subunit and the secondary judgment subunit enables evaluation of the capsule under multiple perturbation conditions, thus improving the comprehensiveness and accuracy of the detection. The secondary judgment subunit, used in the perturbation mode... The second-order judgment can more accurately identify whether a capsule can remain intact under simulated mechanical action, reducing misjudgments caused by a single detection condition. By analyzing real-time images of disturbance, subsequent Class II testing is only performed if the outer surface of the capsule remains intact. This helps optimize the testing process and avoid unnecessary testing of capsules that have already been judged to be unqualified. The linear growth design of the disturbance detection subunit makes the testing process more efficient, enabling the performance evaluation of capsules under disturbance conditions to be completed in a shorter time. Through the linear growth of standard number of tests and real-time image acquisition, the testing process is more objective, reducing the influence of human factors. This improves the accuracy and efficiency of the testing, and also provides a more objective and comprehensive evaluation method for drug quality control.

[0043] By segmenting the dissolution pattern of the target capsule drug, the Class II detection unit can analyze the dissolution behavior of the capsule at different stages in greater detail, thereby improving the accuracy of the detection. Separate analysis of each individual dissolution process ensures that each critical step is recorded and evaluated in detail, helping to identify potential dissolution problems. Three-stage judgment based on single analysis results increases the reliability of the test results, ensuring that only capsules meeting the standards are deemed qualified. The first and second detection subunits determine the actual shell dissolution time and the actual internal substance dissolution time through precise timing; this method provides quantitative data, making the test results more accurate. By introducing a calculated compensation parameter K, the first dissolution score... The system can be adjusted based on the final dissolution state of the capsule shell, making the scoring more reasonable and comprehensive. Using standard shell dissolution time and standard internal substance dissolution time as references helps to unify testing standards and facilitates comparisons between different batches of capsules. Adaptive selection and adjustment based on actual solubility testing accuracy requirements make the testing process more flexible and can meet testing needs in different scenarios. The three judgment sub-units combine the first and second dissolution scores to determine the final judgment result. This comprehensive scoring system can comprehensively evaluate the quality of capsules. Through precise testing and scoring, it ensures that only capsules that meet quality standards can be marketed, thereby improving product quality. The test results can provide feedback to the production process, improving production efficiency.

[0044] The overall analysis unit combines Class I and Class II test results to make a final qualification determination for the target capsule drug, ensuring the comprehensiveness and accuracy of the test results. The grade judgment subunit classifies the capsule drug into qualification grades, not only determining whether the drug is qualified but also distinguishing its quality level. Using the first and second solubility compensation parameters to calculate the overall solubility score balances the impact of different test indicators on the final score, making the score more reasonable. Pre-set scoring ranges and compensation parameters provide clear standards for qualification grade determination, facilitating operation and execution. The output unit provides a detailed description of the capsule drug's solubility performance in the final test report based on the qualification grade, making it easier to understand the drug's quality. Precise grade classification allows for more effective control of product quality, enabling corresponding improvement measures for different grades of drugs. The qualification grade classification helps regulatory authorities conduct more efficient drug quality supervision; based on test results and qualification grades, production processes can be optimized in a targeted manner to improve production efficiency and product quality. Attached Figure Description

[0045] Figure 1 This is a cross-sectional view of a capsule drug solubility detection device according to an embodiment of the present invention;

[0046] Figure 2This is a front view of a capsule drug solubility detection device according to an embodiment of the present invention;

[0047] Figure 3 This is a schematic diagram of the central control assembly in a capsule drug solubility testing device according to an embodiment of the present invention;

[0048] Figure 4 This is a schematic diagram of a type of detection unit structure in the central control assembly of a capsule drug solubility detection device according to an embodiment of the present invention;

[0049] The diagram includes: 1-simulation chamber, 2-stirrer, 3-simulation disturbance rod, 4-liquid pump, 5-vibrator, 6-thermostat, 7-temperature sensor, and 8-vision sensor. Detailed Implementation

[0050] To make the objectives and advantages of the present invention clearer, the present invention will be further described below with reference to embodiments; it should be understood that the specific embodiments described herein are merely for explaining the present invention and are not intended to limit the present invention.

[0051] Preferred embodiments of the present invention will now be described with reference to the accompanying drawings. Those skilled in the art should understand that these embodiments are merely illustrative of the technical principles of the present invention and are not intended to limit the scope of protection of the present invention.

[0052] It should be noted that in the description of this invention, the terms "upper", "lower", "left", "right", "inner", "outer", etc., which indicate directions or positional relationships, are based on the directions or positional relationships shown in the accompanying drawings. This is only for the convenience of description and is not intended to indicate or imply that the device or element must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation of this invention.

[0053] Please see Figures 1-4 As shown, Figure 1 This is a cross-sectional view of a capsule drug solubility detection device according to an embodiment of the present invention; Figure 2 This is a front view of a capsule drug solubility detection device according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the central control assembly in a capsule drug solubility testing device according to an embodiment of the present invention; Figure 4 This is a schematic diagram of a type of detection unit structure in the central control assembly of a capsule drug solubility detection device according to an embodiment of the present invention.

[0054] This invention provides a device for detecting the solubility of capsule drugs, comprising:

[0055] Simulation chamber 1 is the target detection area for the target capsule drug, and the target detection area contains a target simulation liquid;

[0056] The target simulation solution includes: a first target simulation solution and a second target simulation solution; the first target simulation solution is acidic, and the second target simulation solution is alkaline.

[0057] The stirring module includes several stirrers 2; each stirrer 2 is evenly arranged inside the simulation chamber 1; the stirring module stirs the target simulated liquid in the simulation chamber 1 in sections at a preset initial stirring rate to form a simulated flow state.

[0058] The obstacle module includes several simulated disturbance rods 3; each simulated disturbance rod is configured in a bent shape and is uniformly and fixedly disposed inside the simulated cavity 1; the obstacle module is used to provide disturbance.

[0059] The liquid extraction module includes several liquid extraction pumps 4, which are used to replace the target simulation liquid in the simulation chamber 1.

[0060] Vibrator 5 is connected to the simulated cavity 1. The vibrator 5 vibrates the simulated cavity 1 at a preset initial vibration frequency to form a simulated peristaltic state.

[0061] A thermostat 6 is located on one side of the simulation chamber 1 to control the target simulation liquid to be in a constant temperature state.

[0062] Temperature sensor 7 is installed inside the simulation chamber 1 to detect the temperature of the target simulation liquid in real time;

[0063] A visual sensor 8 is mounted on the simulation cavity 1 to monitor the formed target simulation scene in real time;

[0064] The central control assembly performs a first-class detection on the target capsule drug when the first target simulated liquid is contained in the simulation chamber 1. During the first-class detection, it periodically acquires real-time images of various acidic substances monitored by the vision sensor 8 at a preset initial acquisition interval. It analyzes each real-time acidic image and makes a first judgment on the target capsule drug based on the analysis results. Based on the first judgment result, it determines whether to activate a perturbation mode and performs a second judgment on the target capsule drug based on the perturbation mode to obtain a second judgment result. Based on the second judgment result, it determines whether to perform a second-class detection on the target capsule drug. During the second-class detection, it receives real-time images of various alkaline substances monitored by the vision sensor 8 in real time. It analyzes each real-time alkaline image and makes a third judgment on the target capsule drug based on the analysis results. Based on the three judgment results, the central control assembly combines the first and second judgment results to output a final detection report for the target capsule drug.

[0065] The target capsule drug, the target simulation liquid, the stirring module, the obstacle module, the vibrator, and the constant temperature controller together constitute the digestion environment of the target simulation scenario.

[0066] In this embodiment, the simulation cavity 1 and the obstacle module are made of transparent, flexible and acid and alkali resistant materials, such as polyethylene terephthalate (PET), polycarbonate (PC), polyimide (PI), polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), etc. The materials of the simulation cavity 1 and the obstacle module only need to meet the requirements of being transparent, flexible and acid and alkali resistant. This embodiment does not make specific limitations on the specific material type.

[0067] The target capsule drug described in this embodiment is an enteric-coated capsule;

[0068] The simulation cavity 1 simulates different digestive environments depending on the target simulation liquid it contains. When the first target simulation liquid is contained, the simulation cavity 1 is used to simulate the stomach, and the barrier module is used to simulate the stomach wall folds.

[0069] When the second target simulation liquid is contained, the simulation cavity 1 is used to simulate the intestine, and the barrier module is used to simulate the intestinal wall folds;

[0070] The first simulated solution is a simulated gastric juice, which is acidic; the second simulated solution is a simulated intestinal juice, which is alkaline.

[0071] In the specific implementation process, the initial stirring rate is used to simulate the flow of gastric juice. In this embodiment, the initial stirring rate is set to 2 times / minute to 8 times / minute; the initial vibration frequency is used to simulate the peristalsis of the stomach wall. In this embodiment, the initial vibration frequency is set to 3 times / minute to 15 times / minute; the initial acquisition interval is set to 10-15 minutes; and adaptive adjustments are made according to different simulation environments.

[0072] Specifically, the embodiments of the present invention, by using a first target simulated liquid (simulating gastric juice) and a second target simulated liquid (simulating intestinal juice), can simulate the digestive environment of the stomach and intestines respectively; this helps to more accurately evaluate the performance of the capsule at different stages of digestion; the use of a thermostat and a temperature sensor ensures that the simulated liquid maintains a constant temperature throughout the detection process, thereby reducing the impact of temperature fluctuations on the experimental results; the combined use of a stirring module and a vibrator simulates mechanical movements within the human body, such as peristalsis of the stomach and churning of the intestines, which helps to more realistically simulate the behavior of the capsule during digestion; the setting of an obstacle module (simulating a disturbance rod) can simulate the folds of the stomach and intestinal walls, providing additional disturbance to the capsule, thereby more accurately simulating the movement and dissolution of the capsule during actual digestion; the use of a visual sensor allows for real-time monitoring of the capsule's dissolution process. The central control unit analyzes the monitored images, improving the accuracy and efficiency of the detection. It can determine whether to activate the disturbance mode based on the initial judgment results and whether to perform Class II detection based on the secondary judgment results; this process design increases the flexibility and adaptability of the device. The simulation chamber and obstacle module are made of transparent, flexible, and acid- and alkali-resistant materials, which not only facilitates observation of the capsule dissolution process but also adapts to different chemical environments, ensuring the stability and durability of the device. Through primary, secondary, and tertiary judgments, combined with detection results under different conditions, the central control unit can output a more reliable final detection report, providing strong support for drug quality control and evaluation. It provides an efficient, accurate, and reliable experimental platform for the detection of enteric-coated capsules, helping to ensure the safety and efficacy of enteric-coated capsules in the market.

[0073] Specifically, the central control assembly described in this embodiment includes: a type of detection unit;

[0074] The detection unit periodically acquires real-time acidic images of the target capsule drug at the initial acquisition interval, determines whether the outer surface of the target capsule drug is intact based on the real-time acidic images, and determines to activate the perturbation mode if the outer surface of the target capsule drug is intact; determines that the target capsule drug is unqualified if the outer surface of the target capsule drug is incomplete; and performs a secondary determination on the target capsule drug based on the perturbation mode.

[0075] Specifically, in this embodiment, the type of detection unit includes: a primary judgment subunit and a type of verification subunit;

[0076] The first judgment subunit starts timing based on the start of the first type of detection, and ends timing when the timing duration reaches the preset first type of standard duration, so as to obtain the first type of detection duration;

[0077] When the timer ends, a real-time verification image is acquired at that moment. Based on the real-time verification image, it is determined whether the outer surface of the target capsule drug is intact. Based on the condition of the outer surface, it is determined whether to activate the correction mode.

[0078] The verification subunit, when the correction mode is enabled, corrects the initial acquisition interval to obtain the actual acquisition interval.

[0079] In this embodiment, the standard duration is set to 30-50 minutes;

[0080] If the outer surface of the target capsule drug corresponding to the real-time verification image is intact, then the disturbance mode is activated.

[0081] If the outer surface of the target capsule drug corresponding to the real-time verification image is incomplete, then the correction mode is activated.

[0082] When the correction mode is enabled, a correction compensation parameter is set during the process of correcting the initial acquisition interval.

[0083] In the specific implementation process, if the initial acquisition interval is set to 10 minutes, the correction compensation parameter is set to 0.4; then the actual acquisition interval is calculated.

[0084] 10 × (1 - 0.4) = 6.

[0085] Specifically, this invention involves periodically acquiring real-time acidic images of the target capsule drug. A detection unit can accurately determine the integrity of the capsule's outer surface, which is crucial for assessing the capsule's stability in a gastric acid environment. Based on the detection results of the capsule's outer surface integrity, it can intelligently decide whether to activate the perturbation mode. This helps to more realistically simulate the mechanical effects experienced by the capsule in the stomach, thereby improving detection accuracy. The detection unit times a detection period, and stops timing when the detection period reaches a preset standard period. It then acquires a real-time verification image at the moment of timing cessation to determine the integrity of the target capsule drug's outer surface. This allows for dynamic management of whether to directly activate the perturbation mode or correct the initial acquisition interval. The detection process avoids excessively long detection cycles that could prevent the timing of the initial dissolution of the target capsule, ensuring that the detection time is neither too long nor too short, thus improving detection efficiency. It can adjust the detection strategy based on the actual performance of the capsules; real-time correction of the initial acquisition interval yields the actual acquisition interval, which helps to more accurately capture key changes in the capsule during digestion; providing a basis for subsequent detection; more accurately determining whether capsules are qualified, reducing the possibility of misjudgment and missed detection; and optimizing resource utilization by intelligently adjusting the acquisition interval and detection duration, reducing unnecessary detection time and resource consumption. This improves the accuracy, efficiency, and reliability of capsule drug detection, while optimizing the use of detection resources, providing strong technical support for drug quality control.

[0086] Specifically, in this embodiment, the type of detection unit further includes: a disturbance detection subunit and a secondary judgment subunit;

[0087] The disturbance detection subunit is used to linearly increase the initial stirring rate and the initial vibration frequency by a preset growth ratio for a standard number of times based on the disturbance mode, and to acquire real-time images of each disturbance monitored by the visual sensor 8 in real time during the linear growth process.

[0088] The secondary judgment subunit determines whether the outer surface of the target capsule drug is intact based on any real-time disturbed image. If the outer surface of the target capsule drug is intact, it determines that a second-class test should be performed; if the outer surface of the target capsule drug is incomplete, it determines that the target capsule drug is unqualified.

[0089] In this embodiment, the growth rate is set to 5%-8%; the standard number of times is set to 4-9 times; and adaptive adjustments are made according to different simulation environments.

[0090] Specifically, in this embodiment of the invention, by linearly increasing the initial stirring rate and vibration frequency under perturbation mode, the perturbation detection subunit can more realistically simulate the mechanical action experienced by the capsule during human digestion, thereby improving the simulation accuracy of the detection. Real-time perturbation images are acquired during the linear increase process, allowing continuous monitoring of changes in the capsule's outer surface under perturbation, providing detailed data support for subsequent judgment. The secondary judgment subunit analyzes each real-time perturbation image to determine whether the capsule's outer surface is intact, which helps to promptly identify potential problems in the capsule during simulated digestion. The combined use of the perturbation detection subunit and the secondary judgment subunit enables evaluation of the capsule under multiple perturbation conditions, thereby improving the comprehensiveness and accuracy of the detection. The secondary judgment performed under the formula can more accurately identify whether the capsule can remain intact under simulated mechanical action, reducing misjudgments caused by a single detection condition. By analyzing the real-time images of the disturbance, subsequent Class II detection is only performed if the outer surface of the capsule remains intact. This helps optimize the detection process and avoid unnecessary testing of capsules that have already been judged to be unqualified. The linear growth design of the disturbance detection subunit makes the detection process more efficient, enabling the performance evaluation of the capsule under disturbance conditions to be completed in a shorter time. Through the linear growth of the standard number of tests and real-time image acquisition, the detection process is more objective and reduces the influence of human factors. This improves the accuracy and efficiency of the detection, and also provides a more objective and comprehensive evaluation method for drug quality control.

[0091] Specifically, the central control assembly described in this embodiment also includes: a second type of detection unit;

[0092] The second-class detection unit is used to perform segmented detection of the second-class detection process of the target capsule drug according to the dissolution form of the target capsule drug, perform single analysis of the single dissolution process of each segment, and make three judgments based on the single analysis results to obtain the three judgment results.

[0093] Specifically, the two types of detection units in this embodiment include: a first detection subunit and a second detection subunit;

[0094] The first detection subunit, for any alkaline real-time image, if the target capsule drug is found to be ruptured in the alkaline real-time image, then the first detection subunit starts timing until the target capsule shell stops dissolving, and then stops timing to obtain the actual shell dissolution time; a first dissolution score is determined based on the actual shell dissolution time and the final shell dissolution state;

[0095] The second detection subunit, for any alkaline real-time image, if the target capsule shows leakage of the drug, starts timing until the substance inside the target capsule is completely dissolved, and then stops timing to obtain the actual dissolution time of the internal substance; a second dissolution score is determined based on the actual dissolution time of the internal substance.

[0096] The first dissolution score is determined based on the final shell dissolution state.

[0097] When the final shell dissolution state is incomplete dissolution, the first dissolution score is set to -∞;

[0098] When the final shell dissolution state is complete dissolution, the first dissolution score is determined by the ratio between the difference between the standard shell dissolution time and the actual shell dissolution time and the standard shell dissolution time.

[0099] In this embodiment, the standard shell dissolves in 50-60 minutes; the standard internal substance dissolves in 10-15 minutes; and adjustments are made adaptively according to the actual solubility detection accuracy requirements.

[0100] In the specific implementation process, based on the final shell dissolution state being completely dissolved, if the actual shell dissolution time is 45 minutes and the standard shell dissolution time is selected as 55 minutes, then the first dissolution score is calculated as follows:

[0101] [(55-45) / 55]×1=0.18;

[0102] The second dissolution score is determined by the ratio between the difference between the standard internal substance dissolution time and the actual internal substance dissolution time and the standard internal substance dissolution time.

[0103] In the specific implementation process, if the actual internal substance dissolution time is 20 minutes and the selected standard internal substance dissolution time is 13 minutes, then the second dissolution score is calculated as follows:

[0104] [(13-20) / 13]=-0.54.

[0105] Specifically, the second type of detection unit in this embodiment further includes: a three-stage judgment subunit;

[0106] The three-stage determination subunit is used to determine the three-stage determination results based on the first dissolution score and the second dissolution score.

[0107] Specifically, if the first dissolution score is less than 0, the three-stage judgment subunit determines that the target capsule drug is unqualified; if the second dissolution score is less than 0, the three-stage judgment subunit determines that the target capsule drug is unqualified; if both the first dissolution score and the second dissolution score are greater than or equal to 0, the three-stage judgment subunit determines that the target capsule drug is qualified.

[0108] Specifically, this invention improves detection accuracy by segmenting the dissolution pattern of the target capsule drug. The second-class detection unit can analyze the dissolution behavior of the capsule at different stages in greater detail. Separate analysis of each individual dissolution process ensures that each key step is recorded and evaluated in detail, helping to identify potential dissolution problems. Three-stage judgment based on a single analysis result increases the reliability of the detection results, ensuring that only capsules meeting the standards are deemed qualified. The first and second detection subunits determine the actual shell dissolution time and the actual internal substance dissolution time through precise timing. This method provides quantitative data, making the detection results more accurate. By introducing a calculation compensation parameter, the first... The dissolution score can be adjusted based on the final dissolution state of the capsule shell, making the scoring more reasonable and comprehensive. Using standard shell dissolution time and standard internal substance dissolution time as references helps to unify testing standards and facilitates comparisons between different batches of capsules. Adaptive selection and adjustment based on actual solubility testing accuracy requirements make the testing process more flexible and can meet testing needs in different scenarios. The three judgment sub-units combine the first and second dissolution scores to determine the final judgment result. This comprehensive scoring system can comprehensively evaluate the quality of capsules. Through precise testing and scoring, it ensures that only capsules that meet quality standards can be marketed, thereby improving product quality. The test results can provide feedback to the production process, improving production efficiency.

[0109] Specifically, the central control assembly described in this embodiment further includes: an overall analysis unit and an output unit;

[0110] The overall analysis unit determines that the target capsule drug is ultimately qualified when both the Class I and Class II test results are qualified, and determines the qualification level of the target capsule drug based on the Class II test results when the target capsule drug is ultimately qualified.

[0111] The output unit outputs the final test report of the target capsule drug according to the pass level.

[0112] Specifically, the overall analysis unit in this embodiment includes: a level judgment subunit;

[0113] The grade determination subunit calculates the overall dissolution score based on the first dissolution score and the second dissolution score, and determines the qualified grade based on the overall dissolution score.

[0114] The overall dissolution score is determined by the first dissolution score and the second dissolution score. During the determination process, dissolution compensation parameters are set for the first dissolution score and the second dissolution score.

[0115] In the specific implementation process, the first dissolution compensation parameter corresponding to the first dissolution score is set to 0.9; the second dissolution compensation parameter corresponding to the second dissolution score is set to 0.6; the overall dissolution score is calculated based on the first dissolution compensation parameter and the second dissolution compensation parameter;

[0116] 0.18 × 0.9 + (-0.54 × 0.6) = -0.162;

[0117] In this embodiment, the target capsule drug is an enteric-coated capsule. Enteric-coated capsules cannot achieve the expected release rate and concentration in the intestine, which will affect the efficacy of the drug. Furthermore, some drug components in enteric-coated capsules are irritating to the gastric mucosa. If the drug dissolves and is released in the stomach, it will directly contact the gastric mucosa, causing gastric mucosal damage, which may lead to adverse reactions such as nausea, vomiting, and stomach pain, and may even cause serious consequences such as gastric ulcers and bleeding. Therefore, the dissolution rate is crucial to ensuring that the drug is released in the correct location. Therefore, in this embodiment, the first dissolution compensation parameter is greater than the second dissolution compensation parameter.

[0118] The grade determination subunit determines the qualification grade of the capsule drug based on the overall dissolution score; the qualification grade is based on a pre-set score range, and the target capsule drug is divided into grade one, grade two, and grade three according to the score range and the overall dissolution score;

[0119] If the overall dissolution score is less than 0, the target capsule drug is deemed unqualified.

[0120] In the specific implementation process, if the overall dissolution score is equal to 0, the output unit determines that the qualification level is level three;

[0121] If the overall dissolution score is within the range of (1, 1.5), the output unit determines that the qualification level is Level 1.

[0122] If the overall dissolution score is within the range of (0, 1), the output unit determines that the qualification level is Level 2.

[0123] The output unit outputs the final test report of the target capsule drug according to the pass level;

[0124] If the qualification level is Level 1, then the final test report output by the output unit is [Target capsule drug qualified, solubility performance is excellent];

[0125] If the qualification level is Level 2, then the final test report output by the output unit is [Target capsule drug qualified, solubility performance is good];

[0126] If the qualification level is level three, then the final test report output by the output unit is [Target capsule drug qualified, solubility is medium].

[0127] Specifically, this invention, through an overall analysis unit combining Class I and Class II test results, makes a final qualification determination for the target capsule drug, ensuring the comprehensiveness and accuracy of the test results. A grade determination subunit classifies the capsule drug into qualification grades, not only determining whether the drug is qualified but also distinguishing its quality level. Using a first and second dissolution compensation parameter to calculate the overall dissolution score balances the impact of different test indicators on the final score, making the score more reasonable. Pre-set scoring intervals and compensation parameters provide clear standards for qualification grade determination, facilitating operation and execution. The output unit provides a detailed description of the capsule drug's dissolution performance based on the qualification grade, making it easier to understand the drug's quality. Precise grade classification allows for more effective control of product quality, enabling corresponding improvement measures for different grades of drugs. The qualification grade classification helps regulatory authorities conduct drug quality supervision more efficiently; based on test results and qualification grades, production processes can be optimized in a targeted manner, improving production efficiency and product quality.

[0128] The calculation compensation parameters and calculation adjustment parameters described in this invention serve two purposes: first, to balance the left and right dimensions of the formula; and second, to adjust the numerical results. In this embodiment, no specific values ​​are assigned. Furthermore, in this embodiment, each calculation formula is used to intuitively reflect the adjustment relationship between the values, such as positive correlation or negative correlation. Unless otherwise specified, the values ​​of parameters that are not specifically limited are all taken as positive.

[0129] The technical solution of the present invention has been described above with reference to the preferred embodiments shown in the accompanying drawings. However, it will be readily understood by those skilled in the art that the scope of protection of the present invention is obviously not limited to these specific embodiments. Without departing from the principles of the present invention, those skilled in the art can make equivalent changes or substitutions to the relevant technical features, and the technical solutions after these changes or substitutions will all fall within the scope of protection of the present invention.

[0130] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A device for detecting the solubility of capsule drugs, characterized in that, include: The simulation chamber is the target detection area for the target capsule drug, and the target detection area contains a target simulation liquid. The target simulation solution includes: a first target simulation solution and a second target simulation solution; the first target simulation solution is acidic, and the second target simulation solution is alkaline. A stirring module includes several stirrers; each stirrer is evenly arranged inside the simulation chamber; the stirring module stirs the target simulated liquid in the simulation chamber in sections at a preset initial stirring rate to form a simulated flow state. An obstacle module includes several simulated disturbance rods; each simulated disturbance rod is configured in a bent shape and is uniformly and fixedly disposed inside the simulated cavity; the obstacle module is used to provide disturbance. A liquid extraction module, comprising several liquid extraction pumps, is used to replace the target simulation liquid in the simulation chamber; A vibrator is connected to the simulated cavity, and the vibrator vibrates the simulated cavity at a preset initial vibration frequency to form a simulated peristaltic state; A thermostat is located on one side of the simulation chamber to control the target simulation liquid to maintain a constant temperature. A temperature sensor, which is installed inside the simulation chamber, is used to detect the temperature of the target simulated liquid in real time; A visual sensor, which is mounted on the simulation cavity, is used to monitor the formed target simulation scene in real time; The central control assembly performs a first-class detection on the target capsule drug when the simulated cavity contains the first target simulated liquid. During the first-class detection, it periodically acquires real-time images of various acidic substances monitored by the visual sensor at preset initial acquisition intervals. It analyzes these real-time acidic images and makes a first judgment on the target capsule drug based on the analysis results. Based on the first judgment result, it determines whether to activate a disturbance mode and performs a second judgment on the target capsule drug based on the disturbance mode to obtain a second judgment result. Based on the second judgment result, it determines whether to perform a second-class detection on the target capsule drug. During the second-class detection, it receives real-time images of various alkaline substances monitored by the visual sensor. It analyzes these real-time alkaline images and makes a third judgment on the target capsule drug based on the analysis results. Based on the three judgment results, the central control assembly combines the first and second judgment results to output a final detection report for the target capsule drug.

2. The capsule drug solubility detection device according to claim 1, characterized in that, The central control assembly includes: a type of detection unit; The detection unit periodically acquires real-time acidic images of the target capsule drug at the initial acquisition interval, determines whether the outer surface of the target capsule drug is intact based on the real-time acidic images, and determines to activate the perturbation mode if the outer surface of the target capsule drug is intact; determines that the target capsule drug is unqualified if the outer surface of the target capsule drug is incomplete; and performs a secondary determination on the target capsule drug based on the perturbation mode.

3. The capsule drug solubility detection device according to claim 2, characterized in that, The central control assembly also includes: a second-class detection unit; The second-class detection unit is used to perform segmented detection of the second-class detection process of the target capsule drug according to the dissolution form of the target capsule drug, perform single analysis of the single dissolution process of each segment, and make three judgments based on the single analysis results to obtain the three judgment results.

4. The capsule drug solubility detection device according to claim 3, characterized in that, The central control assembly also includes: an overall analysis unit and an output unit; The overall analysis unit determines that the target capsule drug is ultimately qualified when both the Class I and Class II test results are qualified, and determines the qualification level of the target capsule drug based on the Class II test results when the target capsule drug is ultimately qualified. The output unit outputs the final test report of the target capsule drug according to the pass level.

5. The capsule drug solubility detection device according to claim 4, characterized in that, The detection unit includes: a primary judgment subunit and a verification subunit; The first judgment subunit starts timing based on the start of the first type of detection, and ends timing when the timing duration reaches the preset first type of standard duration, so as to obtain the first type of detection duration; When the timer ends, a real-time verification image is acquired at that moment. Based on the real-time verification image, it is determined whether the outer surface of the target capsule drug is intact. Based on the condition of the outer surface, it is determined whether to activate the correction mode. The verification subunit, when the correction mode is enabled, corrects the initial acquisition interval to obtain the actual acquisition interval.

6. The capsule drug solubility detection device according to claim 5, characterized in that, The type of detection unit further includes: a disturbance detection subunit; The disturbance detection subunit is used to linearly increase the initial stirring rate and the initial vibration frequency by a preset growth ratio according to the disturbance mode, and to acquire real-time images of each disturbance monitored by the visual sensor during the linear growth process.

7. The capsule drug solubility detection device according to claim 6, characterized in that, The detection unit further includes: a secondary judgment subunit; The secondary judgment subunit determines whether the outer surface of the target capsule drug is intact based on any real-time disturbed image. If the outer surface of the target capsule drug is intact, it determines that a second-class test should be performed; if the outer surface of the target capsule drug is incomplete, it determines that the target capsule drug is unqualified.

8. The capsule drug solubility detection device according to claim 7, characterized in that, The two types of detection units include: a first detection subunit and a second detection subunit; The first detection subunit, for any alkaline real-time image, if the target capsule drug is found to be ruptured in the alkaline real-time image, then the first detection subunit starts timing until the target capsule shell stops dissolving, and then stops timing to obtain the actual shell dissolution time; a first dissolution score is determined based on the actual shell dissolution time and the final shell dissolution state; The second detection subunit, for any alkaline real-time image, if the target capsule shows leakage of the drug, starts timing until the substance inside the target capsule is completely dissolved, and then stops timing to obtain the actual dissolution time of the internal substance; a second dissolution score is determined based on the actual dissolution time of the internal substance.

9. The capsule drug solubility detection device according to claim 8, characterized in that, The second type of detection unit further includes: a three-stage judgment subunit; The three-stage determination subunit is used to determine the three-stage determination results based on the first dissolution score and the second dissolution score. Wherein, if the first dissolution score is less than or equal to 0, the three-judgment subunit determines that the target capsule drug is unqualified; if the second dissolution score is less than or equal to 0, the three-judgment subunit determines that the target capsule drug is unqualified; if both the first dissolution score and the second dissolution score are greater than 0, the three-judgment subunit determines that the target capsule drug is qualified.

10. The capsule drug solubility detection device according to claim 9, characterized in that, The overall analysis unit includes: a level judgment subunit; The grade determination subunit calculates the overall dissolution score based on the first dissolution score and the second dissolution score, and determines the qualified grade based on the overall dissolution score.

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