A method for detecting the effect of a combination of sitagliptin and metformin sustained-release tablets

Abstract

The present application relates to a kind of siglitin metformin sustained-release tablets combined drug effect detection method in the field of pharmaceutical testing, in the application, by introducing intelligent terminal and monitoring terminal, real-time observation is realized using mechanical vision technology in the experiment process, the observation pressure of experimental personnel is reduced, the labor cost of experimental detection is greatly reduced, the detection efficiency is improved, at the same time, the identity of experimental personnel is identified using intelligent terminal, all experimental operations are bound with its experimental personnel, it is convenient to subsequent summary when experiment is summarized, the traceability work is carried out, the standardization of experimental detection is improved, at the same time, protection unit is set for monitoring terminal, when experimental organism touches trigger lever, a part of stored stimulating smell in slow-release unit is released, the expelling effect is strengthened, and experimental organism is formed to expel domestication, so that experimental organism forms the habit of keeping away from monitoring terminal.

Description

Technical Field

[0001] The present invention relates to a method for detecting the combined drug efficacy, and in particular to a method for detecting the combined drug efficacy of sitagliptin metformin extended-release tablets applied in the field of drug testing. Background Technology

[0002] Combination drug use testing involves detecting potential interactions between two or more drugs when used concurrently. These interactions can alter drug efficacy, including enhancing or diminishing its effects, or causing adverse reactions. The purpose of combination drug use testing is to ensure patient safety and improve treatment outcomes.

[0003] The invention patent CN201510902706.1 discloses a hypoglycemic drug formulation and its experimental method, including the following experimental steps: (1) establishing a rat hyperglycemia model; (2) screening and grouping; (3) detecting indicators; and (4) analyzing, comparing, and drawing conclusions. The formulation in this invention is derived from rigorous scientific experiments and has a good effect on lowering blood sugar and improving insulin resistance. It can provide a research basis for the secondary development of such classic prescriptions and has strong innovation.

[0004] The invention patent CN202410266131.8 discloses a method and system for detecting mouse behavior based on three-dimensional tracking. It simultaneously achieves complete three-dimensional mouse point cloud acquisition, mouse volume measurement and weight estimation, mouse tail length extraction, mouse width acquisition, three-dimensional tracking of multiple mice, and three-dimensional behavior detection of mice. It features high accuracy and saves time and effort, while also enabling the detection of the mouse's physical condition, providing strong technical support for mouse-related experiments such as medical experiments.

[0005] In existing technologies, it is necessary to conduct biological experiments using laboratory mice and monkeys before a drug enters clinical trials. Only drugs that have undergone biological experiments can proceed to the clinical trial stage. During the experiments, researchers need to closely monitor the experimental organisms and deal with any abnormalities in a timely manner. This results in a significant amount of human resources being consumed during the biological experiments when a large amount of experimental data is required. Summary of the Invention

[0006] In view of the above-mentioned prior art, the technical problem to be solved by the present invention is that when biological experiments require a large amount of reliable experimental data, a large amount of human resources are required in the biological experiment process.

[0007] To address the above problems, this invention provides a method for detecting the combined efficacy of sitagliptin and metformin extended-release tablets, comprising the following steps:

[0008] S1. Preparation: Divide the experimental organisms into experimental and control groups according to experimental needs. The experimental groups are further subdivided according to the pre-set experimental needs. Label the experimental organisms and place them into the detection device. Then, prepare sitagliptin metformin extended-release tablets and placebos of the same amount as the control according to the pre-set experimental needs.

[0009] S2. Drug administration: The prepared sitagliptin metformin extended-release tablets and placebo were manually administered to the experimental organism. The monitoring device continued to observe the organism. When the experimental organism exhibited abnormal behavior, the monitoring device issued an abnormality handling alarm and contacted the experimental personnel for manual handling. If the abnormality was determined to be a normal drug response, the drug efficacy test continued. If the abnormality was an abnormal drug response and the abnormality could not be resolved, the drug efficacy test for the experimental organism ended.

[0010] S3. Data statistics: In step S2, after the drug is fed to the preset number of times, the observation data of each experimental organism during the drug effect detection experiment are summarized and statistically analyzed, and the drug response of the experimental organism in this experiment is listed.

[0011] In the above-mentioned method for detecting the combined use of sitagliptin and metformin extended-release tablets, the introduction of intelligent terminals and monitoring terminals enabled real-time observation of the experimental process using machine vision technology, reducing the observation burden on experimental personnel.

[0012] As a further improvement of this application, the detection device includes multiple stacked detection units. Each detection unit includes a cabinet, with a door hinged at the opening of the cabinet. A smart terminal is fixedly connected to the outer end of the cabinet door. The smart terminal includes an operation screen, a processing terminal, and an under-screen fingerprint authentication. A monitoring terminal is fixedly connected to the top of the cabinet.

[0013] As a further improvement of this application, a protective unit is fitted on the outside of the monitoring terminal. The protective unit is fixedly connected to the top plate of the cabinet. The protective unit includes a fixed ring and a protective ring. A pair of trigger rods are fixedly connected between the fixed ring and the protective ring. The trigger rods are hollow and have a pre-made groove on the side of the trigger rods near the protective ring. The fixed ring includes a ring body. A connected slow-release groove and two release channels are carved in the ring body. The two release channels are respectively matched with the positions of the pair of trigger rods. A repelling block is placed in the slow-release groove, and a locking block that matches itself is placed in the release channel. A connecting cable is fixedly connected to the lower end of the locking block. The end of the connecting cable away from the locking block is fixedly connected to the protective ring. If the experimental organism becomes agitated during the combined drug effect detection process, the experimental organism will be repelled to avoid irreversible damage to the monitoring terminal caused by the agitation of the experimental organism.

[0014] As a further improvement to this application, the monitoring terminal is selected from models with infrared tracking function, which enables the lens of the monitoring terminal to track the movement of the experimental organism and improve the video recording quality during the experiment.

[0015] As another improvement of this application, a slow-release unit is fixedly connected to the inner wall of the trigger rod near the fixed ring. The slow-release unit includes multiple elastic fibers in a three-dimensional spiral shape. The multiple elastic fibers overlap each other and form a slow-release structure in the trigger rod remnant connected to the fixed ring, which slows down the dispersion time of the dispersing block and increases the effective service life of the protection unit.

[0016] As a further improvement to this application, the fixing ring includes a ring body, with a sound generator and a light generator fixedly connected to the lower end of the ring body. When the experimental organism remains still for a long time during abnormal sleep, the sound generator and light generator can be activated to provide appropriate stimulation to the experimental organism. The stimulation feedback of the experimental organism can be used to determine whether the experimental organism is in a normal state, which can assist the experimental personnel in their work.

[0017] As a further improvement to this application, the locking block is chiseled with multiple capillary cracks that are interconnected. When the experimental organism touches the remnant of the trigger rod, it will cause the trigger rod and the fixing ring to shake, causing some of the locking block fragments to scatter. This will temporarily damage the structure of the sustained-release unit, release some of the irritating odor stored in the sustained-release unit, enhance the repellency effect, and induce the experimental organism to develop a habit of staying away from the monitoring terminal.

[0018] In summary, this application utilizes intelligent terminals and monitoring terminals to enable real-time observation of the experimental process using machine vision technology. This reduces the observation burden on experimental personnel, significantly lowers the labor costs of experimental testing, and improves testing efficiency. At the same time, the intelligent terminals are used to identify experimental personnel and bind all experimental operations to them, facilitating subsequent summary and traceability during experimental debriefing and improving the standardization of experimental testing.

[0019] Meanwhile, a protection unit was set up for the monitoring terminal. If the experimental organism becomes agitated during the combined drug effect test, the experimental organism will be driven away to avoid irreversible damage to the monitoring terminal caused by the agitation. In addition, the structure of the locking block was designed so that when the experimental organism touches the trigger rod multiple times, some of the locking block fragments will be scattered, causing temporary damage to the structure of the sustained-release unit. This will release some of the irritant odor stored in the sustained-release unit, enhance the driving-away effect, and acclimate the experimental organism to drive it away, so that the experimental organism develops the habit of staying away from the monitoring terminal. Attached Figure Description

[0020] Figure 1This is a flowchart illustrating the combined drug efficacy testing method according to the first embodiment of this application;

[0021] Figure 2 This is a schematic diagram of the combined drug efficacy testing device according to the first embodiment of this application;

[0022] Figure 3 This is a schematic diagram of the detection unit according to the first embodiment of this application;

[0023] Figure 4 This is a schematic diagram of the structure of the smart terminal according to the first embodiment of this application;

[0024] Figure 5 This is a front view of the detection unit cabinet door in the second embodiment of this application when it is open;

[0025] Figure 6 This is a schematic diagram of the structure of the protection unit according to the second embodiment of this application;

[0026] Figure 7 This is a front cross-sectional view of the protection unit according to the second embodiment of this application;

[0027] Figure 8 for Figure 7 Schematic diagram of the structure at point A;

[0028] Figure 9 This is a schematic diagram of the structure of the fixing ring according to the second embodiment of this application;

[0029] Figure 10 This is a front sectional view of the fixing ring according to the second embodiment of this application;

[0030] Figure 11 This is a schematic diagram showing the change of a local structure at the connection between the fixing ring and the trigger rod in the working state according to the second embodiment of this application.

[0031] Explanation of the labels in the diagram:

[0032] 1. Detection unit, 101. Cabinet body, 102. Cabinet door, 103. Intelligent terminal, 2. Monitoring terminal, 3. Protection unit, 301. Fixing ring, 302. Protection ring, 303. Trigger rod, 304. Slow-release unit, 305. Locking block, 306. Connecting cable, 4. Determination block, 5. Ring body, 6. Sound generator, 7. Light generator, 8. Slow-release groove, 9. Release channel. Detailed Implementation

[0033] The two embodiments of this application will now be described in detail with reference to the accompanying drawings.

[0034] First implementation method:

[0035] Figure 1This paper presents a method for detecting the efficacy of sitagliptin-metformin extended-release tablets in combination therapy, including the following steps:

[0036] S1. Preparation: The experimental organisms (including but not limited to laboratory mice and laboratory monkeys, etc., selected by those skilled in the art according to actual testing needs) are divided into experimental groups and control groups according to experimental needs. The experimental groups are further subdivided according to the preset experimental needs (frequency and amount of drug injection), and the experimental organisms are labeled and placed into the testing device. Sitagliptin metformin extended-release tablets and the same amount of placebo for the control (preferably glucose tablets and normal food for the experimental organisms) are prepared according to the preset experimental needs.

[0037] S2. Drug administration: The prepared sitagliptin metformin extended-release tablets and placebo are manually administered to the experimental organism to prevent the organism from chewing and crushing the tablets and placebo during feeding, thus minimizing the impact on the test results. The detection device then continuously monitors the organism. If the experimental organism exhibits abnormal behavior (such as prolonged stillness outside of sleep or prolonged agitation), the detection device issues an abnormality handling alarm and contacts the experimental personnel for manual intervention. If the abnormality is determined to be a normal drug response, the drug efficacy test continues. If the abnormality is an abnormal drug response and the abnormality cannot be resolved, the drug efficacy test for this experimental organism ends.

[0038] S3. Data statistics: In step S2, after the drug is fed to the preset number of times, the observation data of each experimental organism during the drug effect detection experiment are summarized and statistically analyzed, and the drug response of the experimental organism in this experiment is listed.

[0039] Please see Figure 2-5 The detection device includes multiple stacked detection units 1. Each detection unit 1 includes a cabinet 101. A cabinet door 102 is hinged to the opening of the cabinet 101. A smart terminal 103 is fixedly connected to the outer end of the cabinet door 102. The smart terminal 103 includes an operation screen, a processing terminal, and an under-screen fingerprint authentication. A monitoring terminal 2 is fixedly connected to the top of the cabinet 101. This allows for the simultaneous observation of multiple experimental organisms, reducing the observation burden on laboratory personnel. The monitoring terminal 2 can observe the behavior of the experimental organisms and generate video data, which is then transmitted back to the smart terminal 103 and uploaded to the laboratory's experimental terminal. This facilitates the aggregation and unified processing of experimental detection data, significantly reducing the labor costs of experimental detection and improving detection efficiency.

[0040] During the experimental testing process, when the experimental organism exhibits abnormal behavior, the intelligent terminal 103 issues an alarm and the processing terminal captures the corresponding abnormal behavior segment for the experimental personnel to make a preliminary judgment. At the same time, it is also uploaded along with the video data.

[0041] Before the experimenters can handle the anomalies, they need to perform fingerprint authentication on the smart terminal 103. After confirming their identity, the operation screen of the smart terminal 103 is activated, and the experimenters can then carry out subsequent work. All experimental operations can be bound to the experimenters, which is convenient for summarizing and tracing the results during the subsequent experiment summary.

[0042] Compared with existing experimental equipment, this application introduces a smart terminal 103 and a monitoring terminal 2 to realize real-time observation of the experimental process using machine vision technology, reducing the observation pressure on experimental personnel, significantly reducing the labor cost of experimental testing, and improving testing efficiency. At the same time, the smart terminal 103 is used to identify experimental personnel and bind all experimental operations to their respective personnel, which facilitates the summary and traceability work during the subsequent experimental summary and improves the standardization of experimental testing.

[0043] Second implementation method:

[0044] Figure 5-10 The detection device is shown. A protection unit 3 is sleeved on the outside of the monitoring terminal 2. The protection unit 3 is fixedly connected to the top plate of the cabinet 101. The protection unit 3 includes a fixing ring 301 and a protection ring 302. A pair of trigger rods 303 are fixedly connected between the fixing ring 301 and the protection ring 302. The trigger rods 303 are hollow. A pre-made groove is carved on the side of the trigger rods 303 near the protection ring 302. The fixing ring 301 includes a ring body 5. A connected slow-release groove 8 and two release channels 9 are carved in the ring body 5. The two release channels 9 are respectively matched with the positions of the pair of trigger rods 303. A deflection block 4 is placed in the slow-release groove 8. A locking block 305 that matches itself is placed in the release channel 9. A connecting cable 306 is fixedly connected to the lower end of the locking block 305. The end of the connecting cable 306 away from the locking block 305 is fixedly connected to the protection ring 302.

[0045] If the experimental organism becomes agitated during the combined drug efficacy testing process, potentially causing irreversible damage to the monitoring terminal 2, the presence of the protection unit 3 will effectively protect the monitoring terminal 2. Before the experimental organism's body touches the monitoring terminal 2, it will first come into contact with the protection ring 302. When the impact force of the body reaches the point where there is a risk of damaging the monitoring terminal 2, the protection ring 302 will be broken along the precast groove direction. The connecting cable 306 will fall together under the action of the protection ring 302, and the locking block 305 will be pulled out from inside 9 and hang down. At this time, the repelling block 4 will come into contact with the outside world through the release channel 9 and the trigger rod 303, and release an odor to repel the experimental organism and prevent the experimental organism's agitation from causing irreversible damage to the monitoring terminal 2.

[0046] In particular, the selection of repellent block 4 needs to be matched with the experimental organism. That is, the odor produced by repellent block 4 needs to have a repellent effect on the experimental organism. The specific method of repellent block 4 can refer to the manufacturing method of solid aromatherapy to make repellent block 4 with a slow-release effect, so that the protection unit 3 can repel the experimental organism for a long time.

[0047] The monitoring terminal 2 is a model with infrared tracking function, which allows the lens of the monitoring terminal 2 to track the movement of the experimental organism and improve the video recording quality during the experiment.

[0048] A slow-release unit 304 is fixedly connected to the inner wall of the trigger rod 303 near the fixing ring 301. The slow-release unit 304 includes multiple elastic fibers in a three-dimensional spiral shape. The multiple elastic fibers overlap each other and form a slow-release structure in the remnant of the trigger rod 303 connected to the fixing ring 301, which slows down the dispersion time of the dispersing block 4 and increases the effective service time of the protection unit 3.

[0049] The fixed ring 301 includes a ring body 5, with a sound generator 6 and a light generator 7 fixedly connected to the lower end of the ring body 5. When the experimental organism remains still for a long time during abnormal sleep, the sound generator 6 and the light generator 7 can be activated to provide appropriate stimulation to the experimental organism. The stimulation feedback of the experimental organism can be used to determine whether the experimental organism is in a normal state, which can assist the experimental personnel in their work.

[0050] Please see Figure 11 The locking block 305 has multiple capillary cracks that are interconnected. When the protective ring 302 is triggered and pulled, the locking block 305 will be completely broken. After the locking block 305 is broken, some of the overlapping fragments will accumulate on 9, but this will not affect the smooth flow of air in 9. The repelling block 4 can volatilize normally. When the experimental organism touches the remnant of the trigger rod 303 again, it will cause the trigger rod 303 and the fixing ring 301 to shake, causing some of the locking block 305 fragments to fall off. This will temporarily damage the structure of the slow-release unit 304, release some of the irritating odor stored in the slow-release unit 304, enhance the repelling effect, and induce the experimental organism to develop the habit of using the principle monitoring terminal 2.

[0051] In this embodiment, compared to the first embodiment, a detection device is disclosed in detail, and a protection unit 3 is set for the monitoring terminal 2. When the experimental organism becomes agitated during the combined drug effect detection process, the experimental organism is driven away to avoid irreversible damage to the monitoring terminal 2 caused by the agitation of the experimental organism. At the same time, after the structure of the locking block 305 is designed, when the experimental organism touches the trigger rod 303 multiple times, some fragments of the locking block 305 will be scattered, causing temporary damage to the structure of the sustained-release unit 304, releasing some of the irritant odor stored in the sustained-release unit 304, enhancing the driving-away effect, and forming driving-away acclimatization for the experimental organism, so that the experimental organism develops the habit of following the monitoring terminal 2.

[0052] In light of current practical needs, the above-described embodiments adopted in this application are not limited to these. Any changes made within the scope of knowledge possessed by those skilled in the art without departing from the concept of this application still fall within the protection scope of this invention.

Claims

1. A method for detecting the efficacy of sitagliptin-metformin extended-release tablets in combination therapy, characterized in that: Includes the following steps: S1. Preparation: Divide the experimental organisms into experimental and control groups according to experimental needs. The experimental groups are further subdivided according to the pre-set experimental needs. Label the experimental organisms and place them into the detection device. Then, prepare sitagliptin metformin extended-release tablets and placebos of the same amount as the control according to the pre-set experimental needs. The detection device includes multiple stacked detection units (1). Each detection unit (1) includes a cabinet (101). A monitoring terminal (2) is fixedly connected to the top of the cabinet (101). A protective unit (3) is fitted on the outside of the monitoring terminal (2). The protective unit (3) is fixedly connected to the top plate of the cabinet (101). The protective unit (3) includes a fixing ring (301) and a protective ring (302). The fixing ring (301) and the protective ring (302) are connected to each other. A pair of trigger rods (303) are fixedly connected between the protective ring (302), and the trigger rods (303) are hollow. A pre-made groove is carved on the side of the trigger rod (303) near the protective ring (302). The fixed ring (301) includes a ring body (5). A connected slow-release groove (8) and two release channels (9) are carved in the ring body (5). The two release channels (9) are respectively matched with the positions of the pair of trigger rods (303). A dispersing block (4) is placed in the slow-release groove (8). A locking block (305) matching itself is placed in the release channel (9). A connecting cable (306) is fixedly connected to the lower end of the locking block (305). The end of the connecting cable (306) away from the locking block (305) is fixedly connected to the protective ring (302). S2. Drug administration: The prepared sitagliptin metformin extended-release tablets and placebo were manually administered to the experimental organism. The monitoring device continued to observe the organism. When the experimental organism exhibited abnormal behavior, the monitoring device issued an abnormality handling alarm and contacted the experimental personnel for manual handling. If the abnormality was determined to be a normal drug response, the drug efficacy test continued. If the abnormality was an abnormal drug response and the abnormality could not be resolved, the drug efficacy test for the experimental organism ended. S3. Data statistics: In step S2, after the drug is fed to the preset number of times, the observation data of each experimental organism during the drug effect detection experiment are summarized and statistically analyzed, and the drug response of the experimental organism in this experiment is listed.

2. The method for detecting the combined efficacy of sitagliptin and metformin extended-release tablets according to claim 1, characterized in that: The cabinet (101) has a door (102) hinged at the opening. The smart terminal (103) is fixedly connected to the outer end of the door (102). The smart terminal (103) includes an operation screen, a processing terminal, and an under-screen fingerprint authentication.

3. The method for detecting the combined efficacy of sitagliptin and metformin extended-release tablets according to claim 2, characterized in that: The monitoring terminal (2) is selected from models with infrared tracking function.

4. The method for detecting the combined efficacy of sitagliptin and metformin extended-release tablets according to claim 1, characterized in that: The inner wall of the trigger rod (303) near the fixing ring (301) is fixedly connected to a slow-release unit (304), which includes a plurality of elastic fibers in a three-dimensional spiral shape, and the plurality of elastic fibers overlap each other.

5. The method for detecting the combined efficacy of sitagliptin and metformin extended-release tablets according to claim 1, characterized in that: The fixing ring (301) includes a ring body (5), and a sound generator (6) and a light generator (7) are fixedly connected to the lower end of the ring body (5).

6. The method for detecting the combined efficacy of sitagliptin and metformin extended-release tablets according to claim 1, characterized in that: The locking block (305) has multiple capillary cracks, and the multiple capillary cracks are interconnected.

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