Medicinal disintegrating device and use method thereof

Abstract

The invention discloses a medicinal disintegration device and a use method thereof. The medicinal disintegration device comprises a main body, a test area, a constant-temperature water bath device, a sensor system, a camera monitoring system and a control unit, the constant-temperature water bath device is fixedly installed at the bottom of the body, the testing area is located in the constant-temperature water bath device, the camera monitoring system is detachably installed at the top end in the body, and the control unit is embedded into the side face of the body. The testing area comprises at least two dissolution cups which are independently arranged, the dissolution cups are fixed in the constant-temperature water bath device through positioning clamping grooves, and a testing basket or a paddle is arranged in each dissolution cup; the sensor system includes an optical sensor, a pressure sensor, a conductivity sensor, and a temperature sensor. According to the medicinal disintegration device provided by the invention, multi-aspect monitoring of the disintegration process is realized, the test result is accurate and reliable, dynamic visualization and quantitative analysis of the whole disintegration process are realized, and the disintegration detection efficiency is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical analysis and detection equipment, and particularly relates to a medicinal disintegration device and a method for using the same. Background Art

[0002] In pharmaceutical research and development and quality control, the disintegration time limit is a key indicator for evaluating the quality of solid preparations. The current disintegration test methods specified in pharmacopoeias (such as the Chinese Pharmacopoeia and the United States Pharmacopoeia) mainly include the basket method and the paddle method. However, the existing drug disintegrators in the prior art require manual judgment of the drug disintegration situation, consuming a large amount of time and labor costs, and lacking dynamic visualization monitoring of the drug disintegration process. For example, the prior art CN207164030U discloses a drug disintegrator, which includes a control panel, a back plate, a hanging cage and a base. The body also includes a disintegration medium filtration system, and the disintegration medium filtration system successively includes an input pipe, a liquid extraction pump and an output pipe. The drug disintegrator provided by this prior art cannot grasp the dynamic changes in the drug disintegration process in real time, is difficult to accurately analyze the drug disintegration mechanism, and cannot meet the requirements for data real-time and accuracy in modern pharmaceutical research and development and quality control.

[0003] Therefore, there is an urgent need in the art for a medicinal disintegration device and a method for using the same, which are compact in structure and convenient to operate, can realize multi-faceted monitoring of the disintegration process, so as to provide more accurate and reliable disintegration test results and assist in research related to the dynamic changes during the drug disintegration process. Summary of the Invention

[0004] To solve the above technical problems, the present invention provides a medicinal disintegration device, which includes a main body, a test area, a constant temperature water bath device, a sensor system, a camera monitoring system and a control unit;

[0005] The main body is a transparent cuboid. The constant temperature water bath device is fixedly installed at the bottom of the main body. The test area is located inside the constant temperature water bath device. The camera monitoring system is detachably installed at the top inside the main body. The control unit is embedded in the side of the main body;

[0006] The test area includes at least two independently arranged dissolution cups, and the dissolution cups are fixed inside the constant temperature water bath device through positioning card slots. A test basket or a paddle is arranged inside each dissolution cup;

[0007] The sensor system includes an optical sensor, a pressure sensor, a conductivity sensor and a temperature sensor. The optical sensor is fixedly installed on the top of the main body. The pressure sensor, the conductivity sensor and the temperature sensor are distributed and installed inside the dissolution cups in the test area.

[0008] In a specific embodiment, a first driving motor is provided inside the main body. The output shaft of the first driving motor is connected to a detachable hanging basket rod through a first coupling. A test basket is fixedly connected to the bottom end of the hanging basket rod.

[0009] In a specific embodiment, a second driving motor is provided at the bottom of the main body. The output shaft of the second driving motor extends upward and is connected to a detachable paddle shaft through a second coupling. The top end of the paddle shaft is fixedly connected to the paddle blade. The first driving motor and the second driving motor are independently controlled and are respectively used to drive the test basket or the paddle blade to rotate.

[0010] In a specific embodiment, the constant temperature water bath device includes a stainless steel water bath tank and a circulating water pump. A positioning hole matching the outer diameter of the dissolution cup is provided at the top of the water bath tank. The dissolution cup is embedded in the water bath tank through the positioning hole and fixed by a buckle. A sealing hole for the output shaft of the second driving motor to pass through is opened at the bottom of the water bath tank. A waterproof bearing is provided in the sealing hole. The output shaft of the second driving motor is connected to the paddle shaft through the waterproof bearing.

[0011] In a specific embodiment, heating tubes and temperature probes are provided inside the water bath tank. The circulating water pump is connected to both sides of the water bath tank through PVC pipes to form a water flow circulation channel. The temperature control accuracy of the water bath tank is 37°C ± 0.5°C, and the water temperature uniformity error ≤ 0.3°C.

[0012] In a specific embodiment, the temperature sensor is of the PT100 type, is connected to the side of the dissolution cup through an M8 thread, with an accuracy of ±0.1°C. The pressure sensor is of the diffused silicon type, is installed at the center of the bottom of the dissolution cup through an M10 thread, with a measurement range of 0 - 10 kPa and an accuracy of ±0.5% FS. The conductivity sensor is of the two-electrode type, is installed on the side of the dissolution cup through a slot type, with a measurement range of 0 - 200 mS / cm and an accuracy of ±1.5% FS.

[0013] In a specific embodiment, the camera monitoring system includes a camera and an illumination system. The camera is a 360-degree fish-eye camera and is fixed at the center of the top of the disintegrator main body through a universal bracket. The illumination system is an LED ring illumination system, and the LED ring illumination system is arranged around the camera.

[0014] In a specific embodiment, the control unit includes a capacitive touch screen control panel, a data acquisition and transmission module, and a data analysis and processing system;

[0015] The data acquisition and transmission module integrates a multi-channel analog input interface and a wireless transmission module, and can collect sensor data in real time and transmit it to the data analysis and processing system through a shielded cable or wirelessly;

[0016] The data analysis and processing system is equipped with image analysis software, which can fuse multi-source data based on timestamp calibration technology. The image data of the camera monitoring system is transmitted to the control unit in real time through an HDMI cable. The image analysis software can automatically identify the particle size of disintegrated particles, determine the disintegration end point, and calculate the disintegration rate.

[0017] The control panel is provided with method switching buttons. When the basket method mode is selected, the first drive motor is automatically activated and the second drive motor is disabled; when the paddle method mode is selected, the second drive motor is automatically activated and the first drive motor is disabled.

[0018] In a specific embodiment, the test basket is equipped with a detachable basket. The aperture specifications of the basket are 2mm, 1mm or 0.5mm, and the paddle is made of polytetrafluoroethylene.

[0019] In the second aspect of the present application, a method for using a pharmaceutical disintegration device is provided. The method for using is based on the aforementioned pharmaceutical disintegration device, and the steps included in the method for using are as follows:

[0020] S1. Parameter setting:

[0021] Select the basket method or paddle method test mode through the control panel. The system automatically activates the corresponding drive motor and disables the other drive motor; according to the disintegration conditions, set the disintegration speed and disintegration time; turn on the lighting system and calibrate the white balance of the camera; confirm the water level in the water bath, set the water bath temperature to 37°C ± 0.5°C and wait for stability.

[0022] S2. Disintegration test:

[0023] During the basket method test, put the sample into the test basket; during the paddle method test, put the sample into the dissolution cup.

[0024] Turn on the motor, sensor system and camera monitoring system through the control panel to monitor the pressure, temperature, conductivity curve and the video of the disintegration process in real time.

[0025] When the image analysis software determines the disintegration end point, it automatically stops, and a test report containing multi-parameter data is generated.

[0026] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0027] 1. The pharmaceutical disintegration device provided by the present invention realizes the full-range monitoring of the disintegration process by integrating a variety of sensors and monitoring systems, and can monitor multiple key parameters including the disintegration time, disintegration rate, temperature, pressure change and the physical state of particles during the disintegration process in real time, providing accurate and reliable disintegration test results, realizing the dynamic visualization and quantitative analysis of the whole disintegration process, automatically determining the end point according to the data conclusion, reducing the human operation error, and improving the efficiency of disintegration detection.

[0028] 2. The medicinal disintegration device provided by the present invention integrates the basket method test and the paddle method test into the same device, improving the detection efficiency and practicability of the device, while reducing the space occupied by the equipment and effectively reducing the labor and economic costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 is the front view structural schematic diagram of the medicinal disintegration device provided by the present invention;

[0030] Figure 2 is the side view structural schematic diagram of the medicinal disintegration device provided by the present invention;

[0031] In the figure, 1 - main body, 2 - control unit, 3 - method switching button, 4 - optical sensor, 5 - lighting system, 6 - camera, 7 - hanging basket rod, 8, water bath tank, 9 - dissolution cup, 10 temperature sensor, 11 - basket, 12 - pressure sensor, 13 conductivity sensor, 14 - paddle. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0032] The technical solutions of the present invention will be clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without making creative efforts shall fall within the scope of protection of the present invention. The materials, instruments, reagents, etc. used in the following embodiments can be obtained from commercial channels without special instructions. The technical means used in the embodiments are conventional means well known to those skilled in the art without special instructions.

[0033] The structures, ratios, sizes, etc. shown in the drawings of this specification are only used to cooperate with the content disclosed in the specification for those familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention. Therefore, they do not have technical substance significance. Any modification of the structure, change of the proportional relationship or adjustment of the size, without affecting the efficacy and purpose that the present invention can achieve, should still fall within the scope covered by the technical content disclosed by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" cited in this specification are only for the convenience of clear narration and are not used to limit the scope for the implementation of the present invention. The change or adjustment of their relative relationship, without substantial change in the technical content, should also be regarded as the scope for the implementation of the present invention.

[0034] Embodiment 1

[0035] As Figure 1-2 shown, this embodiment shows a medicinal disintegration device, including a main body, a test area, a constant temperature water bath device, a sensor system, a camera monitoring system and a control unit;

[0036] The main body 1 is a transparent cuboid. The constant temperature water bath device is fixedly installed at the bottom of the main body 1. The test area is located inside the constant temperature water bath device. The camera monitoring system is detachably installed at the top inside the main body 1. The control unit 2 is embedded in the side of the main body 1.

[0037] The test area includes at least two independently arranged dissolution cups 9. The dissolution cups 9 are fixed inside the constant temperature water bath device through positioning card slots. A test basket or paddle 14 is arranged inside each dissolution cup 9.

[0038] The sensor system includes an optical sensor 4, a pressure sensor 12, a conductivity sensor 13, and a temperature sensor 10. The optical sensor 4 is fixedly installed on the top of the main body 1. The pressure sensor 12, the conductivity sensor 13, and the temperature sensor 10 are distributed and installed inside the dissolution cups 9 in the test area.

[0039] A first driving motor is provided on the inner side of the main body 1. The output shaft of the first driving motor is connected to the detachable hanging basket rod 7 through a first coupling. The bottom end of the hanging basket rod 7 is fixedly connected with a test basket. The hanging basket rod 7 has a diameter of 6 mm and a length of 200 mm. The middle part of the hanging basket rod 7 is provided with an external thread, and the inner wall of the first coupling is provided with a matching internal thread. The hanging basket rod 7 is detachably fixed to the first coupling through threaded connection. The test basket includes an annular basket frame and a screen connected to the bottom of the basket frame. The top of the basket frame is connected to the bottom end of the hanging basket rod 7 through a quick-release buckle. The test basket is equipped with a detachable basket 11, and the aperture specification of the basket 11 is 2 mm, 1 mm, or 0.5 mm.

[0040] A second driving motor is provided at the bottom of the main body 1. The output shaft of the second driving motor extends upward and is connected to the detachable paddle shaft through a second coupling. The top end of the paddle shaft is fixedly connected with a paddle 14. The paddle shaft has a diameter of 8 mm. The bottom end of the paddle shaft is provided with an external thread, and the inner wall of the second coupling is provided with a matching internal thread. The paddle shaft is detachably fixed to the second coupling through threaded connection; the paddle 14 is made of polytetrafluoroethylene, with a smooth surface and no adsorptivity, a diameter of 50 mm. A screw hole is provided at the center of the bottom of the paddle 14. The top end of the paddle shaft is fixedly connected to the paddle 14 through the screw hole; the first driving motor and the second driving motor are independently controlled, and the speed regulation range is 25 - 200 rpm, which are respectively used to drive the test basket or the paddle 14 to rotate.

[0041] The constant temperature water bath device includes a stainless steel water bath tank 8 and a circulation water pump. The inside of the water bath tank 8 is provided with a heating pipe and a PT100 temperature probe. The circulation water pump is connected to both sides of the water bath tank 8 through a PVC pipe to form a water flow circulation channel. The water temperature control accuracy of the water bath tank 8 is 37°C ± 0.5°C, and the water temperature uniformity error ≤ 0.3°C. The water bath tank 8 is provided with an overheat protection switch, which automatically cuts off the heating power when the water temperature exceeds 40°C; the power of the circulation water pump is 50 W, and the water flow circulation speed is 10 L / min, ensuring uniform distribution of the water temperature inside the water bath tank 8.

[0042] The top of the water bath box 8 is provided with positioning holes matching the outer diameter of the dissolution cup 9. The dissolution cup 9 is embedded in the water bath box 8 through the positioning holes and fixed by buckles. The bottom of the water bath box 8 is provided with a sealing hole for the output shaft of the second drive motor to pass through. A waterproof bearing is provided in the sealing hole, and the output shaft of the second drive motor is connected to the paddle shaft through the waterproof bearing.

[0043] The dissolution cup 9 is a cylindrical borosilicate glass container with an inner diameter of 8 - 10 cm, a height of 12 - 15 cm, and a volume of 500 mL. A temperature sensor 10 mounting hole and a conductivity sensor 13 slot are provided in the middle of the side of the dissolution cup 9. A pressure sensor 12 threaded interface is provided at the center of the bottom. The temperature sensor 10 is connected to the side of the dissolution cup 9 through an M8 thread, with an accuracy of ±0.1 °C. The pressure sensor 12 is of the diffused silicon type and is installed at the center of the bottom of the dissolution cup 9 through an M10 thread, with a measurement range of 0 - 10 kPa and an accuracy of ±0.5% FS. The conductivity sensor 13 is of the two-electrode type and is installed on the side of the dissolution cup 9 through a slot, with a measurement range of 0 - 200 mS / cm and an accuracy of ±1.5% FS.

[0044] The camera monitoring system includes a camera 6 and a lighting system 5. The camera 6 is a 360-degree fisheye camera 6, which is fixed at the center of the top of the disintegrator main body 1 through a universal bracket. The lighting system 5 is an LED ring lighting system 5, and the LED ring lighting system 5 is arranged around the camera 6. The lighting intensity adjustment range is 500 - 2000 Lux.

[0045] The control unit 2 includes a capacitive touch screen control panel, a data acquisition and transmission module, and a data analysis and processing system;

[0046] The data acquisition and transmission module integrates multi-channel analog input interfaces and a wireless transmission module, and can collect sensor data in real time and transmit it to the data analysis and processing system through a shielded cable or wirelessly;

[0047] The data analysis and processing system is equipped with image analysis software, which can fuse multi-source data based on timestamp calibration technology. The image data of the camera monitoring system is transmitted to the control unit 2 in real time through an HDMI cable. The image analysis software can automatically identify the particle size of the disintegrated particles, determine the disintegration end point (such as particle size < 0.5 mm), and calculate the disintegration rate;

[0048] The control panel is provided with a method switching button 3. When the basket method mode is selected, the first drive motor is automatically activated and the second drive motor is disabled; when the paddle method mode is selected, the second drive motor is automatically activated and the first drive motor is disabled.

[0049] The control unit 2 can be externally connected to a human-computer interaction interface, a computer, and a printer in a wired or wireless manner to assist the operator in observing and recording the disintegration process, and synchronously store or print relevant data.

[0050] The usage method of the pharmaceutical disintegration device of the present application is as follows:

[0051] S1. Parameter setting:

[0052] Select the basket method or paddle method test mode through the control panel. The system automatically activates the corresponding drive motor and disables the other drive motor. When selecting the basket method test, the system activates the first drive motor and disables the second drive motor. When selecting the paddle method test, the system disables the first drive motor and activates the second drive motor. According to the disintegration conditions, set the disintegration rotation speed and disintegration time; turn on the lighting system 5 and calibrate the white balance of the camera 6; confirm the water level in the water bath tank 8, set the water bath temperature to 37°C ± 0.5°C and wait for it to stabilize;

[0053] S2. Disintegration test:

[0054] During the basket method test, put the sample into the test basket. During the paddle method test, put the sample into the dissolution cup 9;

[0055] Turn on the motor, sensor system and camera monitoring system through the control panel, and monitor the pressure, temperature, conductivity curve and the video of the disintegration process in real time;

[0056] When the image analysis software determines the disintegration end point, it automatically stops, and generates a test report containing multi-parameter data.

[0057] During the basket method test, the real-time image of the tablet can be observed to watch the disintegration process. When the image analysis software detects that the particle size is all < 0.5 mm, the device automatically stops. During the paddle method test, synchronously record the conductivity curve (reflecting the change of ion concentration) and absorbance data (calculating the dissolution rate). When the absorbance change rate < 0.1% / min and the image shows no complete particles, the disintegration end point is determined.

[0058] In summary, the above embodiments are only the preferred embodiments of the present invention, and are not intended to limit the protection scope of the present invention. Any modifications, equivalent replacements, improvements, 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 medicinal disintegration device, characterized in that, The described pharmaceutical disintegration device includes a main body, a test area, a constant temperature water bath device, a sensor system, a camera monitoring system, and a control unit; The main body is a transparent cuboid. The constant temperature water bath device is fixedly installed at the bottom of the main body. The test area is located inside the constant temperature water bath device. The camera monitoring system is detachably installed at the top inside the main body. The control unit is embedded in the side of the main body; The test area includes at least two independently arranged dissolution cups. The dissolution cups are fixed inside the constant temperature water bath device through positioning card slots. A test basket or paddle is arranged inside each dissolution cup; The sensor system includes an optical sensor, a pressure sensor, a conductivity sensor, and a temperature sensor. The optical sensor is fixedly installed on the top of the main body. The pressure sensor, conductivity sensor, and temperature sensor are distributed and installed inside the dissolution cups in the test area.

2. The medicinal disintegration device according to claim 1, wherein, A first driving motor is provided on the inner side of the main body. The output shaft of the first driving motor is connected to a detachable hanging basket rod through a first coupling. A test basket is fixedly connected to the bottom end of the hanging basket rod.

3. The pharmaceutical disintegration device according to claim 2, wherein, A second driving motor is provided at the bottom of the main body. The output shaft of the second driving motor extends upward and is connected to a detachable paddle shaft through a second coupling. The paddle is fixedly connected to the top end of the paddle shaft. The first driving motor and the second driving motor are independently controlled and are respectively used to drive the test basket or the paddle to rotate.

4. The pharmaceutical disintegration device according to claim 3, characterized in that, The constant temperature water bath device includes a stainless steel water bath tank and a circulation water pump. A positioning hole matching the outer diameter of the dissolution cup is provided at the top of the water bath tank. The dissolution cup is embedded in the water bath tank through the positioning hole and fixed by a buckle. A sealing hole for the output shaft of the second driving motor to pass through is opened at the bottom of the water bath tank. A waterproof bearing is provided in the sealing hole. The output shaft of the second driving motor is connected to the paddle shaft through the waterproof bearing.

5. The medicinal disintegration device according to claim 4, characterized in that, Heating pipes and temperature probes are provided inside the water bath tank. The circulation water pump is connected to both sides of the water bath tank through PVC pipes to form a water flow circulation channel. The water temperature control accuracy of the water bath tank is 37°C ± 0.5°C, and the water temperature uniformity error ≤ 0.3°C.

6. The medicinal disintegration device according to claim 1, wherein, The temperature sensor is of the PT100 type and is connected to the side of the dissolution cup through an M8 thread, with an accuracy of ±0.1°C. The pressure sensor is of the diffused silicon type and is installed at the center of the bottom of the dissolution cup through an M10 thread, with a measurement range of 0 - 10 kPa and an accuracy of ±0.5% FS. The conductivity sensor is of the two-electrode type and is installed on the side of the dissolution cup through a slot type, with a measurement range of 0 - 200 mS / cm and an accuracy of ±1.5% FS.

7. The pharmaceutical disintegration device according to claim 1, wherein The camera monitoring system includes a camera and a lighting system. The camera is a 360-degree fisheye camera and is fixed at the center of the top of the disintegrator main body through a universal bracket. The lighting system is an LED ring lighting system, and the LED ring lighting system is arranged around the camera.

8. The medicinal disintegration device according to claim 3, characterized in that, The control unit includes a capacitive touch screen control panel, a data acquisition and transmission module, and a data analysis and processing system; The data acquisition and transmission module integrates a multi-channel analog input interface and a wireless transmission module, and can collect sensor data in real time and transmit it to the data analysis and processing system through a shielded cable or wirelessly; The data analysis and processing system is equipped with image analysis software, which can fuse multi-source data based on timestamp calibration technology. The image data of the camera monitoring system is transmitted to the control unit in real time through an HDMI cable. The image analysis software can automatically identify the particle size of disintegrated particles, determine the disintegration end point, and calculate the disintegration rate. The control panel is provided with a method switching button. When the basket method mode is selected, the first drive motor is automatically activated and the second drive motor is disabled; when the paddle method mode is selected, the second drive motor is automatically activated and the first drive motor is disabled.

9. The pharmaceutical disintegration device according to the claim, characterized in that The test basket is equipped with a detachable basket. The aperture specifications of the basket are 2mm, 1mm or 0.5mm. The paddle is made of polytetrafluoroethylene.

10. A method for using a medicinal disintegration device, characterized in that, The usage method is based on the pharmaceutical disintegration device according to any one of claims 1-9. The steps included in the usage method are as follows: S1. Parameter setting: Select the basket method or paddle method test mode through the control panel. The system automatically activates the corresponding drive motor and disables the other drive motor; according to the disintegration conditions, set the disintegration speed and disintegration time; turn on the lighting system and calibrate the camera white balance; confirm the water level in the water bath tank, set the water bath temperature to 37°C ± 0.5°C and wait for stability. S2. Disintegration test: During the basket method test, place the sample in the test basket. During the paddle method test, place the sample in the dissolution cup. Turn on the motor, sensor system and camera monitoring system through the control panel to monitor the pressure, temperature, conductivity curve and the video of the disintegration process in real time. When the image analysis software determines the disintegration end point, it automatically stops, and a test report containing multi-parameter data is generated.

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