Capsule drug solubility detection device

Abstract

The invention relates to the technical field of medicine capsule detection, in particular to a capsule medicine solubility detection device which comprises an obstacle module, a liquid pumping module, a vibrator, a constant temperature controller, a temperature sensor, a visual sensor and a central control assembly. The method comprises the following steps: analyzing each acid real-time image, performing primary judgment on a target capsule medicine according to an analysis result to determine whether to start a disturbance mode, and performing secondary judgment on the target capsule medicine based on the disturbance mode to obtain a secondary judgment result; determining whether to perform second-class detection on the target capsule medicine or not according to the secondary judgment result; receiving each alkalinity real-time image monitored by the visual sensor in real time in the second-class detection process; analyzing each alkalinity real-time image so as to judge the target capsule medicine for three times; based on the third judgment result, the central control assembly outputs a final detection report of the target capsule medicine in combination with the first judgment result and the second judgment result.

Description

Technical Field

[0001] The present invention relates to the technical field of drug capsule detection, in particular to a device for detecting the solubility of drug capsules. Background Art

[0002] Enteric-coated capsules are widely used in the medical field. Their unique dissolution mechanism enables drugs to be accurately delivered to the intestines, thereby exerting the best therapeutic effect and reducing irritation to the gastric mucosa. However, if enteric-coated capsules are used without solubility testing, they may dissolve prematurely in the stomach due to the effect of gastric acid, causing the drug to be released prematurely, resulting in failure to achieve the expected release rate and concentration in the intestine, thereby affecting the efficacy of the drug. In addition, some drug ingredients in enteric-coated capsules are irritating to the gastric mucosa. If the drug dissolves and releases in the stomach, it will directly contact the gastric mucosa and cause gastric mucosal damage, which may lead to adverse reactions such as nausea, vomiting, stomach pain, and may even cause serious consequences such as gastric ulcers and bleeding. Therefore, in order to ensure the efficacy and safety of enteric-coated capsules, solubility testing is required before use to ensure its integrity.

[0003] Chinese patent application publication number CN112557610A discloses a biological capsule solubility detection device, which includes: a mounting frame for mounting the entire device; a rotation detection component mounted on the mounting frame and providing power for rotation detection; a material discharge component mounted on the mounting frame and performing material discharge by sliding; a moving component mounted on the mounting frame and moving by sliding, the moving component cooperating with the material discharge component.

[0004] It can be seen that the current capsule drug solubility detection device cannot effectively reflect the actual situation of capsule dissolution, and thus cannot accurately detect the solubility of drug capsules. Summary of the invention

[0005] To this end, the purpose of the present invention is to provide a capsule drug solubility detection device to overcome the problem that the current capsule drug solubility detection device cannot effectively reflect the actual situation of capsule dissolution, and thus cannot accurately detect the solubility of drug capsules.

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

[0007] A simulation cavity, which is a target detection area of ​​a target capsule medicine, and a target simulation liquid is contained in the target detection area;

[0008] Wherein, the target simulation liquid comprises: a first target simulation liquid and a second target simulation liquid; the first target simulation liquid is acidic, and the second target simulation liquid is alkaline;

[0009] A stirring module, comprising a plurality of stirrers; each stirrer is evenly arranged inside the simulation chamber; the stirring module stirs the target simulation liquid in the simulation chamber 1 in different zones at a preset initial stirring rate to form a simulated flow state;

[0010] The obstacle module comprises a plurality of simulated disturbance rods; each simulated disturbance rod is arranged in a bent shape and is evenly and fixedly arranged inside the simulation cavity; the obstacle module is used to provide disturbance;

[0011] A liquid pumping module, comprising a plurality of liquid pumps, and the liquid pumping module is used to replace the target simulation liquid in the simulation cavity;

[0012] a vibrator connected to the simulation cavity, the vibrator vibrating the simulation cavity at a preset initial vibration frequency to form a simulated peristaltic state;

[0013] A constant temperature controller, which is arranged on one side of the simulation chamber and is used to control the target simulation fluid to be in a constant temperature state;

[0014] A temperature sensor is disposed in the simulation cavity to detect the temperature of the target simulation fluid in real time;

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

[0016] A central control assembly performs a first-class detection on the target capsule drug when the first target simulation liquid is contained in the simulation cavity, and periodically acquires each acid real-time image monitored by the visual sensor at a preset initial acquisition interval during the first-class detection process; analyzes each acid real-time image, and makes a first judgment on the target capsule drug based on the analysis result; determines whether to turn on the disturbance mode based on the first judgment result, and makes a second judgment on the target capsule drug based on the disturbance mode to obtain a second judgment result; determines whether to perform a second-class detection on the target capsule drug based on the second judgment result; receives each alkaline real-time image monitored by the visual sensor in real time during the second-class detection process; analyzes each alkaline real-time image, and makes a third judgment on the target capsule drug based on the analysis result; based on the third judgment results, the central control assembly outputs a final detection report of the target capsule drug in combination with the first judgment result and the second judgment result.

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

[0018] The first type of detection unit periodically acquires each acidity real-time image of the target capsule medicine at the initial acquisition interval, determines whether the outer surface of the target capsule medicine is intact according to the acidity real-time image; and determines to start the disturbance mode based on the outer surface of the target capsule medicine being intact; determines that the target capsule medicine is unqualified based on the outer surface of the target capsule medicine being incomplete; and performs a secondary determination on the target capsule medicine based on the disturbance mode.

[0019] Furthermore, the central control assembly further comprises: a second type of detection unit;

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

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

[0022] The overall analysis unit determines that the target capsule drug is finally qualified based on the first-category test result and the second-category test result when both are qualified, and determines the qualified grade of the target capsule drug according to the second-category test result when the target capsule drug is finally qualified;

[0023] The output unit outputs a final test report of the target capsule medicine according to the qualified grade.

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

[0025] The primary judgment subunit starts timing based on the start of the first type of detection until the timing duration reaches a preset first type of standard duration, then the timing ends to obtain the first type of detection duration;

[0026] When the timing ends, a real-time verification image at that moment is obtained, and whether the outer surface of the target capsule medicine is intact is determined according to the real-time verification image; and whether to start the correction mode is determined according to the outer surface condition;

[0027] The first type of verification subunit amends the initial acquisition interval to obtain the actual acquisition interval based on starting the correction mode.

[0028] Further, the type of 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 standard number of times at a preset growth ratio based on the disturbance pattern, and to obtain real-time images of each disturbance monitored by the visual sensor in real time during the linear growth process.

[0030] Furthermore, the first type of detection unit also includes a secondary judgment subunit;

[0031] The secondary judgment subunit determines whether the outer surface of the target capsule medicine is intact for any disturbed real-time image according to the disturbed real-time image, and determines to perform the second type of detection based on the outer surface of the target capsule medicine being intact; and determines that the target capsule medicine is unqualified based on the outer surface of the target capsule medicine being incomplete.

[0032] Further, 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 ruptured in the alkaline real-time image, starts timing until the shell of the target capsule stops dissolving and then stops timing to obtain an actual shell dissolution time; determines a first dissolution score according to the actual shell dissolution time and the final shell dissolution state;

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

[0035] Furthermore, the second-class detection unit further includes: a three-determination subunit;

[0036] The three-determination subunit is used to determine the three-determination results according to the first dissolution score and the second dissolution score;

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

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

[0039] The grade judgment subunit calculates an overall dissolution score according to the first dissolution score and the second dissolution score, and determines the qualified grade according to the overall dissolution score.

[0040] Compared with the prior art, the beneficial effects of the present invention are that by using the first target simulated liquid (simulated gastric fluid) and the second target simulated liquid (simulated intestinal fluid), the digestive environment of the stomach and intestine can be simulated respectively; it helps to more accurately evaluate the performance of the capsule at different digestion stages; the use of a constant temperature controller 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 in the human body, such as gastric peristalsis and intestinal stirring, which helps to more realistically simulate the behavior of the capsule during the digestion process; the setting of the obstacle module (simulated disturbance rod) can simulate the wrinkles of the stomach wall and the intestinal wall, providing additional disturbances to the capsule, thereby more accurately simulating the movement and dissolution of the capsule during the actual digestion process; the use of a visual sensor allows real-time monitoring of the dissolution of the capsule The central control assembly analyzes the monitored images during the dissolution process, thereby improving the accuracy and efficiency of the detection. The central control assembly can decide whether to turn on the disturbance mode based on the preliminary judgment result, and decide whether to conduct the second-class detection based on the secondary judgment result. Such a process design increases the flexibility and adaptability of the device. The simulation cavity and the obstacle module are made of transparent, flexible and acid-resistant materials, which not only facilitates the observation of the capsule dissolution process, but also can adapt to different chemical environments, ensuring the stability and durability of the device. Through the first, second and third judgments, and combined with the test results under different conditions, the central control assembly can output a more reliable final test report, providing strong support for the quality control and evaluation of drugs. It provides an efficient, accurate and reliable experimental platform for the detection of enteric-coated capsules, which helps to ensure the safety and effectiveness of enteric-coated capsules in the market.

[0041] By periodically acquiring real-time acid images of the target capsule drug, a type of detection unit can accurately determine whether the outer surface of the capsule is intact, which is crucial for evaluating the stability of the capsule in the gastric acid environment; based on the detection results of the integrity of the capsule's outer surface, it can intelligently decide whether to turn on the perturbation mode, which helps to more realistically simulate the mechanical effects on the capsule in the stomach, thereby improving the accuracy of the detection; a type of detection unit times the duration of a type of detection, and stops timing when the duration of a type of detection reaches a preset type of standard duration, and obtains a real-time verification image at the moment of stopping timing, thereby determining the integrity of the outer surface of the target capsule drug, and thus determining whether to directly turn on the perturbation mode or to correct the initial acquisition interval. The detection process can be dynamically managed to avoid It can avoid the inability to time the dissolution of the target capsule drug due to a long detection cycle, and ensure that the detection is neither too long nor too short, thereby improving the detection efficiency; it can adjust the detection strategy according to the actual performance of the capsule; it can correct the initial acquisition interval in real time to obtain the actual acquisition interval, which helps to more accurately capture the key changes of the capsule in the digestion process; it can provide a basis for judgment for subsequent detection; it can more accurately determine whether the capsule is qualified, reducing the possibility of misjudgment and missed detection; by intelligently adjusting the acquisition interval and detection time, it can optimize resource utilization and reduce unnecessary detection time and resource consumption; it can improve 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 disturbance mode, the disturbance detection subunit can more realistically simulate the mechanical effects on the capsule during the human digestion process, thereby improving the simulation degree of the detection; by acquiring the real-time disturbance image in real time during the linear growth process, the changes in the outer surface of the capsule when disturbed can be continuously monitored, providing detailed data support for subsequent judgments; the secondary judgment subunit analyzes each disturbance real-time image to determine whether the outer surface of the capsule is intact, which helps to promptly discover potential problems of the capsule in the simulated digestion process; through the combined use of the disturbance detection subunit and the secondary judgment subunit, the capsule can be evaluated under multiple disturbance conditions, thereby improving the comprehensiveness and accuracy of the detection; the secondary judgment subunit performed in the disturbance mode This judgment can more accurately identify whether the capsule can remain intact under the simulated mechanical action, reducing misjudgment caused by a single detection condition; through the analysis of the disturbed real-time image, the subsequent second-class test will be carried out only when the outer surface of the capsule remains intact, which helps to optimize the detection process and avoid unnecessary testing of capsules that have been judged as unqualified; the linear growth design of the disturbance detection subunit makes the detection process more efficient and can complete the performance evaluation of the capsule under disturbance conditions in a shorter time; through the linear growth of the standard number of times and real-time image acquisition, the detection process is more objective and the influence of human factors is reduced; the accuracy and efficiency of the detection are improved, and at the same time, a more objective and comprehensive evaluation method is provided for drug quality control.

[0043] By performing segmented detection on the dissolution morphology of the target capsule drug, the second-class detection unit can analyze the dissolution behavior of the capsule at different stages in more detail, thereby improving the accuracy of the detection; the separate analysis of the single dissolution process of each single-stage process can ensure that each key step is recorded and evaluated in detail, which helps to discover potential dissolution problems; three judgments are made based on a single analysis result, which increases the reliability of the test results and ensures that only capsules that meet the standards can be judged as qualified; the first detection subunit and the second detection subunit determine the actual shell dissolution time and the actual internal material dissolution time through precise timing. This method provides quantitative data, making the test results more accurate; by introducing the calculation compensation parameter K, the first dissolution score It can be adjusted according to the final dissolution state of the capsule shell, which makes the scoring more reasonable and comprehensive; using the standard shell dissolution time and the standard internal material dissolution time as a reference helps to unify the detection standards and facilitate comparison between different batches of capsules; adaptive selection and adjustment are made according to the actual solubility detection accuracy requirements, making the detection process more flexible and able to meet the detection needs in different scenarios; the three judgment sub-units combine the first dissolution score and the second dissolution score to determine the final judgment result. This comprehensive scoring system can comprehensively evaluate the quality of the capsule; through precise testing and scoring, it is ensured that only capsules that meet the quality standards can be put on the market, thereby improving product quality; the test results can provide feedback for the production process and improve production efficiency.

[0044] The overall analysis unit combines the first-class test results and the second-class test results to make a final qualified judgment on the target capsule drug, ensuring the comprehensiveness and accuracy of the test results; the qualified grades of the capsule drugs are divided by the grade judgment subunit, which can not only determine whether the drugs are qualified, but also distinguish the quality grades of the drugs. The first dissolution compensation parameter and the second dissolution compensation parameter are used to calculate the overall dissolution score, which can balance the influence of different test indicators on the final score and make the score more reasonable; the pre-set score interval and compensation parameters provide clear standards for the determination of qualified grades, which is easy to operate and execute; the final test report output by the output unit according to the qualified grade describes the dissolution performance of the capsule drug in detail, which is easy to understand the quality of the drug; through precise grade division, product quality can be controlled more effectively, and corresponding improvement measures can be taken for drugs of different grades; the division of qualified grades helps regulatory authorities to conduct drug quality supervision more efficiently. According to the test results and qualified grades, the production process can be optimized in a targeted manner to improve production efficiency and product quality. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] Figure 1 A cross-sectional view of a device for detecting the solubility of a capsule drug 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 structural diagram of a central control assembly in a capsule drug solubility detection device according to an embodiment of the present invention;

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

[0049] The figure includes: 1-simulation chamber, 2-stirrer, 3-simulation disturbance rod, 4-liquid pump, 5-vibrator, 6-constant temperature controller, 7-temperature sensor, 8-visual sensor. DETAILED DESCRIPTION

[0050] In order to make the objects and advantages of the present invention more clearly understood, the present invention is further described below in conjunction with embodiments; it should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0051] The preferred embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood by those skilled in the art that these embodiments are only used to explain the technical principles of the present invention and are not intended to limit the protection scope of the present invention.

[0052] It should be noted that, in the description of the present invention, terms such as "up", "down", "left", "right", "inside" and "outside" indicating directions or positional relationships are based on the directions or positional relationships shown in the drawings. This is merely for the convenience of description and does not indicate or imply that the device or element must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it cannot be understood as a limitation on the present invention.

[0053] See also Figure 1-Figure 4 As shown, Figure 1 A cross-sectional view of a device for detecting the solubility of a capsule drug 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 structural diagram of a central control assembly in a capsule drug solubility detection device according to an embodiment of the present invention; Figure 4 The present invention is a schematic diagram of the structure of a type of detection unit in a central control assembly in a capsule medicine solubility detection device according to an embodiment of the present invention.

[0054] The present invention provides a capsule drug solubility detection device, comprising:

[0055] A simulation cavity 1, which is a target detection area of ​​a target capsule medicine, and a target simulation liquid is contained in the target detection area;

[0056] Wherein, the target simulation liquid comprises: a first target simulation liquid and a second target simulation liquid; the first target simulation liquid is acidic, and the second target simulation liquid is alkaline;

[0057] A stirring module, comprising a plurality of stirrers 2; each stirrer 2 is evenly arranged inside the simulation chamber 1; the stirring module stirs the target simulation liquid in the simulation chamber 1 in a partitioned manner at a preset initial stirring rate to form a simulated flow state;

[0058] The obstacle module comprises a plurality of simulated disturbance rods 3; each simulated disturbance rod is arranged in a bent shape and is evenly and fixedly arranged inside the simulation cavity 1; the obstacle module is used to provide disturbance;

[0059] A liquid pumping module, comprising a plurality of liquid pumps 4, and the liquid pumping module is used to replace the target simulation liquid in the simulation chamber 1;

[0060] a vibrator 5 connected to the simulation cavity 1, wherein the vibrator 5 vibrates the simulation cavity 1 at a preset initial vibration frequency to form a simulated peristaltic state;

[0061] A constant temperature controller 6, which is arranged on one side of the simulation chamber 1 and is used to control the target simulation fluid to be in a constant temperature state;

[0062] A temperature sensor 7, which is disposed in the simulation chamber 1 and is used to detect the temperature of the target simulation fluid in real time;

[0063] A visual sensor 8, which is arranged on the simulation cavity 1, and is used to monitor the formed target simulation scene in real time;

[0064] A central control assembly, which performs a first-class detection on the target capsule medicine when the first target simulation liquid is contained in the simulation cavity 1, and periodically acquires each acid real-time image monitored by the visual sensor 8 at a preset initial acquisition interval during the first-class detection process; analyzes each acid real-time image, and makes a primary determination on the target capsule medicine according to the analysis result; determines whether to turn on the disturbance mode according to the primary determination result, and makes a secondary determination on the target capsule medicine based on the disturbance mode to obtain a secondary determination result; determines whether to perform a second-class detection on the target capsule medicine according to the secondary determination result; receives each alkaline real-time image monitored by the visual sensor 8 in real time during the second-class detection process; analyzes each alkaline real-time image, and makes a third determination on the target capsule medicine according to the analysis result; based on the third determination results, 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;

[0065] The target capsule medicine, the target simulated liquid, the stirring module, the barrier module, the vibrator and the constant temperature controller together constitute the digestive environment of the target simulation scene.

[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 are transparent, flexible and acid- and alkali-resistant, and the specific material type is not specifically limited in this embodiment;

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

[0068] The simulation chamber 1 simulates different digestive environments according to different target simulation liquids contained therein. When the first target simulation liquid is contained therein, the simulation chamber 1 is used to simulate the stomach, and the obstacle module is used to simulate the folds of the stomach wall.

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

[0070] The first simulated liquid is simulated gastric fluid, which is acidic; the second simulated liquid is simulated intestinal fluid, which is alkaline.

[0071] During 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-8 times / minute; the initial vibration frequency is used to simulate the peristalsis of the gastric wall. In this embodiment, the initial vibration frequency is set to 3 times / minute-15 times / minute; the initial acquisition interval is set to 10-15 minutes; and adaptive selection and adjustment are performed according to different simulation environments.

[0072] Specifically, the embodiments of the present invention can simulate the digestive environment of the stomach and intestines respectively by using the first target simulated liquid (simulated gastric fluid) and the second target simulated liquid (simulated intestinal fluid); it helps to more accurately evaluate the performance of the capsule at different digestion stages; the use of a constant temperature controller 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 in the human body, such as gastric peristalsis and intestinal stirring, which helps to more realistically simulate the behavior of the capsule during the digestion process; the setting of the obstacle module (simulated disturbance rod) can simulate the wrinkles of the stomach wall and the intestinal wall, providing additional disturbances for the capsule, thereby more accurately simulating the movement and dissolution of the capsule during the actual digestion process; the use of a visual sensor allows real-time monitoring of the dissolution process of the capsule, The monitored images are analyzed by the central control assembly to improve the accuracy and efficiency of the detection. The central control assembly can decide whether to turn on the disturbance mode based on the preliminary judgment result, and decide whether to conduct the second-class detection based on the secondary judgment result. Such process design increases the flexibility and adaptability of the device. The simulation cavity and obstacle module are made of transparent, flexible and acid-resistant materials, which not only facilitates the observation of the dissolution process of the capsule, but also can adapt to different chemical environments, ensuring the stability and durability of the device. Through primary, secondary and tertiary judgments, and combined with the test results under different conditions, the central control assembly can output a more reliable final test report, providing strong support for the quality control and evaluation of drugs. It provides an efficient, accurate and reliable experimental platform for the detection of enteric-coated capsules, which helps to ensure the safety and effectiveness 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 first type of detection unit periodically acquires each acidity real-time image of the target capsule medicine at the initial acquisition interval, determines whether the outer surface of the target capsule medicine is intact according to the acidity real-time image; and determines to start the disturbance mode based on the outer surface of the target capsule medicine being intact; determines that the target capsule medicine is unqualified based on the outer surface of the target capsule medicine being incomplete; and performs a secondary determination on the target capsule medicine based on the disturbance mode.

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

[0076] The primary judgment subunit starts timing based on the start of the first type of detection until the timing duration reaches a preset first type of standard duration, then the timing ends to obtain the first type of detection duration;

[0077] When the timing ends, a real-time verification image at that moment is obtained, and whether the outer surface of the target capsule medicine is intact is determined according to the real-time verification image; and whether to start the correction mode is determined according to the outer surface condition;

[0078] The first type of verification subunit, based on starting the correction mode, corrects the initial acquisition interval to obtain the actual acquisition interval;

[0079] In this embodiment, the first type of standard duration is set to 30min-50min;

[0080] When the outer surface of the target capsule medicine corresponding to the real-time verification image is intact, it is determined to start the disturbance mode;

[0081] When the outer surface of the target capsule medicine corresponding to the real-time verification image is incomplete, it is determined to start the correction mode;

[0082] When the correction mode is turned on, a correction compensation parameter is set in 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, the embodiment of the present invention periodically acquires the acidity real-time image of the target capsule medicine, and a type of detection unit can accurately determine whether the outer surface of the capsule is intact, which is crucial for evaluating the stability of the capsule in the gastric acid environment; based on the detection result of the integrity of the outer surface of the capsule, it can intelligently decide whether to turn on the perturbation mode, which helps to more realistically simulate the mechanical action of the capsule in the stomach, thereby improving the accuracy of the detection; a type of detection unit times the duration of a type of detection, and stops timing when the duration of a type of detection reaches a preset type of standard duration, and acquires a real-time verification image at the moment of stopping timing, thereby judging the integrity of the outer surface of the target capsule medicine, and thus judging whether to directly turn on the perturbation mode or to correct the initial acquisition interval, which can dynamically manage The detection process can avoid the detection cycle being too long, which will result in the inability to time the target capsule drug's beginning to dissolve, and can also ensure that the detection is neither too long nor too short, thereby improving the detection efficiency; the detection strategy can be adjusted according to the actual performance of the capsule; the initial acquisition interval can be corrected in real time to obtain the actual acquisition interval, which helps to more accurately capture the key changes of the capsule in the digestion process; provide a basis for judgment for subsequent detection; it can more accurately determine whether the capsule is qualified, reducing the possibility of misjudgment and missed detection; by intelligently adjusting the acquisition interval and detection time, it can optimize resource utilization and reduce unnecessary detection time and resource consumption; it can improve 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 one 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 standard number of times at a preset growth ratio based on the disturbance pattern, and to obtain 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 medicine is intact for any disturbed real-time image according to the disturbed real-time image, and determines to perform the second type of detection based on the outer surface of the target capsule medicine being intact; and determines that the target capsule medicine is unqualified based on the outer surface of the target capsule medicine being incomplete.

[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 selection and adjustment are performed according to different simulation environments.

[0090] Specifically, in the embodiment of the present invention, by linearly increasing the initial stirring rate and the vibration frequency in the disturbance mode, the disturbance detection subunit can more realistically simulate the mechanical effects on the capsule during the human digestion process, thereby improving the simulation degree of the detection; the disturbance real-time image is acquired in real time during the linear growth process, and the changes in the outer surface of the capsule when disturbed can be continuously monitored, providing detailed data support for subsequent judgments; the secondary judgment subunit analyzes each disturbance real-time image to determine whether the outer surface of the capsule is intact, which helps to promptly discover potential problems of the capsule in the simulated digestion process; through the combined use of the disturbance detection subunit and the secondary judgment subunit, the capsule can be evaluated under multiple disturbance conditions, thereby improving the comprehensiveness and accuracy of the detection; in the disturbance mode The secondary judgment performed under the above formula can more accurately identify whether the capsule can remain intact under the simulated mechanical action, reducing the misjudgment caused by a single detection condition; through the analysis of the disturbed real-time image, the subsequent second-class test will be carried out only when the outer surface of the capsule remains intact, which helps to optimize the detection process and avoid unnecessary testing of capsules that have been judged as unqualified; the linear growth design of the disturbance detection subunit makes the detection process more efficient and can complete the performance evaluation of the capsule under disturbance conditions in a shorter time; through the linear growth of the standard number of times and the acquisition of real-time images, the detection process is more objective and the influence of human factors is reduced; the accuracy and efficiency of the detection are improved, and at the same time, a more objective and comprehensive evaluation method is provided for drug quality control.

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

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

[0093] Specifically, the second type of detection unit in this embodiment includes: 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 ruptured in the alkaline real-time image, starts timing until the shell of the target capsule stops dissolving and then stops timing to obtain an actual shell dissolution time; determines a first dissolution score according to 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 drug leaks in the alkaline real-time image, starts timing until the internal substance of the target capsule is completely dissolved and then stops timing to obtain the actual internal substance dissolution time; and determines the second dissolution score according to the actual internal substance dissolution time;

[0096] The first dissolution score is determined by 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, a first dissolution score is determined by a ratio between a 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 dissolution time is 50-60 minutes; the standard internal substance dissolution time is 10-15 minutes; and the adaptive selection and adjustment are performed according to the actual solubility detection accuracy requirements.

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

[0101] [(55-45) / 55]×1=0.18;

[0102] Determining a second dissolution score 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 material dissolution time obtained is 20 minutes, and the selected standard internal material dissolution time is 13 minutes, then the second dissolution score is calculated as:

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

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

[0106] The three-determination subunit is used to determine the three-determination results according to the first dissolution score and the second dissolution score;

[0107] Among them, if the first dissolution score is less than 0, the three-determination subunit determines that the three-determination results are that the target capsule drug is unqualified; if the second dissolution score is less than 0, the three-determination subunit determines that the three-determination results are that the target capsule drug is unqualified; based on the first dissolution score and the second dissolution score are both greater than or equal to 0, the three-determination subunit determines that the three-determination results are that the target capsule drug is qualified.

[0108] Specifically, the embodiment of the present invention performs segmented detection on the dissolution morphology of the target capsule drug. The second detection unit can analyze the dissolution behavior of the capsule at different stages in more detail, thereby improving the accuracy of the detection; a separate analysis of the single dissolution process of each single-stage process can ensure that each key step is recorded and evaluated in detail, which helps to discover potential dissolution problems; three judgments are made based on a single analysis result, which increases the reliability of the detection result and ensures that only capsules that meet the standards can be judged as qualified; the first detection subunit and the second detection subunit determine the actual shell dissolution time and the actual internal substance dissolution time through precise timing. This method provides quantitative data, making the detection result more accurate; by introducing calculation compensation parameters, the first detection subunit can determine the actual shell dissolution time and the actual internal substance dissolution time. The first dissolution score can be adjusted according to the final dissolution state of the capsule shell, which makes the score more reasonable and comprehensive; using the standard shell dissolution time and the standard internal material dissolution time as a reference helps to unify the test standards and facilitate comparison between different batches of capsules; adaptive selection and adjustment are made according to the actual solubility test accuracy requirements, making the test process more flexible and able to meet the test needs in different scenarios; the three judgment sub-units combine the first dissolution score and the second dissolution score to determine the final judgment result. This comprehensive scoring system can comprehensively evaluate the quality of the capsule; through precise testing and scoring, it is ensured that only capsules that meet quality standards can be put on the market, thereby improving product quality; the test results can provide feedback for the production process and improve production efficiency.

[0109] Specifically, the central control assembly 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 finally qualified based on the first-category test result and the second-category test result when both are qualified, and determines the qualified grade of the target capsule drug according to the second-category test result when the target capsule drug is finally qualified;

[0111] The output unit outputs a final test report of the target capsule medicine according to the qualified grade.

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

[0113] The grade judgment subunit calculates an overall dissolution score according to the first dissolution score and the second dissolution score, and determines the qualified grade according to the overall dissolution score.

[0114] Determining the overall dissolution score by using the first dissolution score and the second dissolution score During the determination, a dissolution compensation parameter is set for the first dissolution score and the second dissolution score;

[0115] In a 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; and 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, which cannot achieve the expected release rate and concentration in the intestine, which will affect the efficacy of the drug; and some drug components in the enteric-coated capsule are irritating to the gastric mucosa. If the drug is dissolved and 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 ensure that the drug is released at the correct location; so in this embodiment, the first dissolution compensation parameter is greater than the second dissolution compensation parameter;

[0118] The grade judgment subunit determines the qualified grade of the capsule medicine according to the overall dissolution score; the qualified grade is divided based on a preset score interval, and the target capsule medicine is divided into first grade, second grade, and third grade according to the score interval and the overall dissolution score;

[0119] If the overall dissolution score is less than 0, the target capsule drug is judged to be unqualified;

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

[0121] If the overall dissolution score is within the interval of (1, 1.5), the output unit determines that the qualified grade is level one;

[0122] If the overall dissolution score is within the interval of (0, 1], the output unit determines that the qualified grade is level 2;

[0123] The output unit outputs a final test report of the target capsule medicine according to the qualified grade;

[0124] If the qualified grade is level one, the final test report output by the output unit is [the target capsule drug is qualified, and the dissolution performance is excellent];

[0125] If the qualified grade is level 2, the final test report output by the output unit is [the target capsule drug is qualified, and the dissolution performance is good];

[0126] If the qualified grade is level three, the final test report output by the output unit is [the target capsule drug is qualified, and the dissolution performance is medium].

[0127] Specifically, the embodiment of the present invention combines the first and second test results through the overall analysis unit to make a final qualified judgment on the target capsule medicine, thereby ensuring the comprehensiveness and accuracy of the test results; the qualified grades of the capsule medicine are divided by the grade judgment subunit, which can not only determine whether the medicine is qualified, but also distinguish the quality grade of the medicine. The first dissolution compensation parameter and the second dissolution compensation parameter are used to calculate the overall dissolution score, which can balance the influence of different test indicators on the final score, making the score more reasonable; the pre-set score interval and compensation parameter provide clear standards for the determination of the qualified grade, which is easy to operate and execute; the final test report output by the output unit according to the qualified grade describes the dissolution performance of the capsule medicine in detail, which is easy to understand the quality of the medicine; through accurate grade division, product quality can be more effectively controlled, and corresponding improvement measures can be taken for drugs of different grades; the division of qualified grades helps regulatory authorities to conduct drug quality supervision more efficiently, and according to the test results and qualified grades, the production process can be optimized in a targeted manner to improve production efficiency and product quality.

[0128] The calculation compensation parameters and the calculation adjustment parameters described in the present invention have two functions: one is to balance the left and right dimensions of the formula, and the other is to adjust the numerical results. No specific assignment is performed in this embodiment. In addition, the calculation formulas in this embodiment are used to intuitively reflect the adjustment relationship between the numerical values, such as positive correlation and negative correlation. Unless otherwise specified, the parameter values ​​that are not specifically limited to numerical values ​​are all positive.

[0129] So far, the technical solutions of the present invention have been described in conjunction with the preferred embodiments shown in the accompanying drawings. However, it is easy for those skilled in the art to understand that the protection scope of the present invention is obviously not limited to these specific embodiments. Without departing from the principle 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 fall within the protection scope of the present invention.

[0130] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A capsule drug solubility detection device, characterized in that: include: A simulation cavity, which is a target detection area of ​​a target capsule medicine, and a target simulation liquid is contained in the target detection area; Wherein, the target simulation liquid comprises: a first target simulation liquid and a second target simulation liquid; the first target simulation liquid is acidic, and the second target simulation liquid is alkaline; A stirring module, comprising a plurality of stirrers; each stirrer is evenly arranged inside the simulation chamber; the stirring module stirs the target simulation liquid in the simulation chamber 1 in different zones at a preset initial stirring rate to form a simulated flow state; The obstacle module comprises a plurality of simulated disturbance rods; each simulated disturbance rod is arranged in a bent shape and is evenly and fixedly arranged inside the simulation cavity; the obstacle module is used to provide disturbance; A liquid pumping module, comprising a plurality of liquid pumps, and the liquid pumping module is used to replace the target simulation liquid in the simulation cavity; a vibrator connected to the simulation cavity, the vibrator vibrating the simulation cavity at a preset initial vibration frequency to form a simulated peristaltic state; A constant temperature controller, which is arranged on one side of the simulation chamber and is used to control the target simulation fluid to be in a constant temperature state; A temperature sensor is disposed in the simulation cavity to detect the temperature of the target simulation fluid in real time; A visual sensor is arranged on the simulation cavity to monitor the formed target simulation scene in real time; A central control assembly performs a first-class detection on the target capsule drug when the first target simulation liquid is contained in the simulation cavity, and periodically acquires each acid real-time image monitored by the visual sensor at a preset initial acquisition interval during the first-class detection process; analyzes each acid real-time image, and makes a first judgment on the target capsule drug based on the analysis result; determines whether to turn on the disturbance mode based on the first judgment result, and makes a second judgment on the target capsule drug based on the disturbance mode to obtain a second judgment result; determines whether to perform a second-class detection on the target capsule drug based on the second judgment result; receives each alkaline real-time image monitored by the visual sensor in real time during the second-class detection process; analyzes each alkaline real-time image, and makes a third judgment on the target capsule drug based on the analysis result; based on the third judgment results, the central control assembly outputs a final detection report of the target capsule drug in combination with the first judgment result and the second judgment result.

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 first type of detection unit periodically acquires each acidity real-time image of the target capsule medicine at the initial acquisition interval, determines whether the outer surface of the target capsule medicine is intact according to the acidity real-time image; and determines to start the disturbance mode based on the outer surface of the target capsule medicine being intact; determines that the target capsule medicine is unqualified based on the outer surface of the target capsule medicine being incomplete; and performs a secondary determination on the target capsule medicine based on the disturbance mode.

3. The capsule drug solubility detection device according to claim 2, characterized in that: The central control assembly also includes: a second type of detection unit; The second-category detection unit is used to perform segmented detection on the second-category detection process of the target capsule drug according to the dissolution form of the target capsule drug, perform a single analysis on the single dissolution process of each single-stage process, and perform three judgments based on the single analysis result 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 finally qualified based on the first-category test result and the second-category test result when both are qualified, and determines the qualified grade of the target capsule drug according to the second-category test result when the target capsule drug is finally qualified; The output unit outputs a final test report of the target capsule medicine according to the qualified grade.

5. The capsule drug solubility detection device according to claim 4, characterized in that: The type of detection unit includes: a primary judgment subunit and a type of verification subunit; The primary judgment subunit starts timing based on the start of the first type of detection until the timing duration reaches a preset first type of standard duration, then the timing ends to obtain the first type of detection duration; When the timing ends, a real-time verification image at that moment is obtained, and whether the outer surface of the target capsule medicine is intact is determined according to the real-time verification image; and whether to start the correction mode is determined according to the outer surface condition; The first type of verification subunit amends the initial acquisition interval to obtain the actual acquisition interval based on starting the correction mode.

6. The capsule drug solubility detection device according to claim 5, characterized in that: The type of detection unit also 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 standard number of times at a preset growth ratio based on the disturbance pattern, and to obtain real-time images of each disturbance monitored by the visual sensor in real time during the linear growth process.

7. The capsule drug solubility detection device according to claim 6, characterized in that: The first type of detection unit also includes: a secondary judgment subunit; The secondary judgment subunit determines whether the outer surface of the target capsule medicine is intact for any disturbed real-time image according to the disturbed real-time image, and determines to perform the second type of detection based on the outer surface of the target capsule medicine being intact; and determines that the target capsule medicine is unqualified based on the outer surface of the target capsule medicine being incomplete.

8. The capsule drug solubility detection device according to claim 7, characterized in that: The second type of detection unit includes: 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 ruptured in the alkaline real-time image, starts timing until the shell of the target capsule stops dissolving and then stops timing to obtain an actual shell dissolution time; determines a first dissolution score according to the actual shell dissolution time and the final shell dissolution state; The second detection subunit, for any alkaline real-time image, if the alkaline real-time image shows leakage of the target capsule drug, the second detection subunit starts timing until the internal substance of the target capsule is completely dissolved and then stops timing to obtain the actual dissolution time of the internal substance; and determines the second dissolution score according to 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 detection unit also includes: a three-time determination subunit; The three-determination subunit is used to determine the three-determination results according to the first dissolution score and the second dissolution score; Among them, if the first dissolution score is less than or equal to 0, the three-determination subunit determines that the three-determination results are that the target capsule drug is unqualified; if the second dissolution score is less than or equal to 0, the three-determination subunit determines that the three-determination results are that the target capsule drug is unqualified; based on the first dissolution score and the second dissolution score are both greater than 0, the three-determination subunit determines that the three-determination results are 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 judgment subunit calculates an overall dissolution score according to the first dissolution score and the second dissolution score, and determines the qualified grade according to the overall dissolution score.

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