An automated device for detecting the radiochemical purity of radiopharmaceuticals

Abstract

This utility model relates to an automated device for detecting the radiochemical purity of radiopharmaceuticals, comprising: a marking assembly including a marking pen, a vertical telescopic module, a horizontal movement module, and an infrared sensor; a spotting assembly for spotting samples on a chromatographic paper strip; a climbing assembly including a first robotic arm and a developing cylinder, the first robotic arm being equipped with a first suction cup; a cutting assembly including a second robotic arm with twelve blades for cutting the chromatographic paper strip; a measuring assembly including a third robotic arm, a fourth robotic arm, a test tube, and a lead-shielded measuring chamber; a driving assembly including a transmission module and a placement platform, the placement platform being used to place and fix the chromatographic paper strip, and the transmission module being used to move the chromatographic paper strip into various workstations; and a control center for coordinating the timing of each component and performing motion control. Compared with the prior art, this utility model has advantages such as automation and efficiency, high precision and accuracy, and radiation protection safety.

Description

Technical Field

[0001] This utility model relates to the field of radiopharmaceutical quality control technology, and in particular to an automated device for detecting the radiochemical purity of radiopharmaceuticals. Background Technology

[0002] Radiochemical purity (RCP) of radiopharmaceuticals is a core indicator for evaluating their quality, directly affecting drug safety and efficacy. Currently, the eleven-segment method is a commonly used method for detecting radiochemical purity. The steps are as follows: 1) Mark the spotting points on the chromatographic paper strip with a pencil; 2) Manually divide the chromatographic paper strip into 11 segments; 3) Spot the radiopharmaceutical; 4) Place the strip into a developing tank; 5) Once the solvent front reaches approximately the center of the eleventh segment, immediately remove the chromatographic paper and allow it to dry; 6) After cutting off the chromatographic paper before the first segment, place the chromatographic paper from each of the eleven segments into eleven test tubes; 7) Manually measure the radioactivity of each segment and calculate the purity.

[0003] Traditional methods rely on manual visual positioning and manual cutting of chromatographic paper, which have the following problems:

[0004] 1. Large positioning error: It is difficult to align the chromatographic paper tape with the scale lines, resulting in inaccurate segment division;

[0005] 2. Low efficiency: Manual segmented measurement is time-consuming and the results are easily affected by operational errors;

[0006] 3. Inadequate radiation protection: Frequent contact with radioactive samples may increase the risk of radiation exposure for operators.

[0007] Patent CN202411357272.7 discloses an automated aseptic inspection system and method for radioactive drugs, including: a loading module for placing vials, culture flasks, and syringes; a vial opening mechanism for opening the vials; a moving device equipped with a sample transfer device and a syringe control device; the sample transfer device for moving the vials and culture flasks; the syringe control device for connecting to the syringes and driving the plunger on the syringes to extract and inject the drug; a culture and detection module for placing culture flasks and culturing the drug; the culture and detection module is equipped with a camera for photographing and detecting the drug inside the culture flasks; and a waste bin. Some parts require manual operation, and there are deficiencies in radiation protection.

[0008] Therefore, there is an urgent need for an auxiliary tool, an automated device that can standardize positioning, automatically segment and cut, and reduce radiation exposure. Utility Model Content

[0009] The purpose of this invention is to overcome the shortcomings of the existing technology and provide an automated device for detecting the radiochemical purity of radiopharmaceuticals, which can quickly and accurately assist in the 11-segment rapid detection method, thereby improving detection efficiency and accuracy.

[0010] The objective of this utility model can be achieved through the following technical solutions:

[0011] This utility model provides an automated device for detecting the radiochemical purity of radiopharmaceuticals, comprising:

[0012] The marking component includes: a marking pen, a vertical telescopic module, a forward and backward movement module, and an infrared sensor; the vertical telescopic module is connected to the marking pen, the vertical telescopic module drives the marking pen to move up and down, and the forward and backward movement module drives the marking pen and the vertical telescopic module to move back and forth to draw lines;

[0013] The spotting assembly is used to spot samples at the spotting points on the chromatographic paper strip;

[0014] The plate-climbing assembly includes a first robotic arm and a developing cylinder. The first robotic arm is equipped with a first suction cup, which picks up the chromatographic paper strip and places it into the developing cylinder for plate climbing.

[0015] The cutting assembly includes a second robotic arm equipped with twelve blades for cutting the chromatogram paper strip;

[0016] The measurement assembly includes a third robotic arm, a fourth robotic arm, test tubes, and a lead-shielded measurement chamber. Eleven test tubes are provided. The fourth robotic arm has eleven third suction cups, each used to pick up a chromatographic paper strip divided into eleven segments and place them into the test tubes. The third robotic arm has a second suction cup, which is arc-shaped and mates with the outer surface of the test tubes. The third robotic arm is used to pick up the test tubes and place them into the lead-shielded measurement chamber. The lead-shielded measurement chamber has eleven channels for placing test tubes, enabling simultaneous measurement of the activity of each segment.

[0017] The drive assembly includes a transmission module and a placement platform. The placement platform is used to place and fix the chromatographic paper tape, and the transmission module is used to drive the chromatographic paper tape to move into each station.

[0018] The control center coordinates the timing of various components and performs motion control, communicating with each component via a bus.

[0019] Coordinate the timing of each component: trigger actions such as marking, sampling, board climbing, cutting, and measurement according to the process;

[0020] Motion control: Adjusting motor speed, stroke, and synchronization (e.g., the coordination between a robotic arm and a conveyor belt);

[0021] Data acquisition: Records activity data from the lead-shielded measurement chamber and automatically calculates RCP;

[0022] Safety monitoring: Real-time detection of radiation dose, emergency shutdown in case of abnormality.

[0023] The transmission module is a conveyor belt, which is driven by a motor.

[0024] Furthermore, the forward and backward movement module includes a lead screw slide mechanism driven by a stepper motor, and the lead screw slide mechanism includes a guide rail and a slider; the forward and backward movement module drives the marker pen to move along the width direction of the chromatographic paper tape, and cooperates with the up and down telescopic module to complete the drawing of 11 marker lines.

[0025] Furthermore, the vertical telescopic module is a synchronous belt drive system driven by a servo motor. The servo motor receives instructions from the control center through the controller to achieve precise vertical displacement.

[0026] Furthermore, the infrared sensor is used to detect whether the chromatographic paper tape has reached the marking station. When the chromatographic paper tape blocks the infrared beam, the infrared sensor sends a signal to the control center to trigger the marking component to operate.

[0027] Furthermore, a pressure sensor is provided at the end of the upper and lower telescopic modules to monitor the contact pressure between the marker pen and the chromatography paper strip in real time.

[0028] Furthermore, the spotting assembly includes a micro-injection pump driven by a stepper motor.

[0029] Furthermore, the dotting component includes a vision-assisted positioning unit, which is a 5MP industrial camera. Through the calculation of coordinates by the control center, it can achieve dotting at the dotting location.

[0030] Furthermore, the inner walls of the 11 test tube channels of the lead-shielded measurement chamber are coated with scintillator material, and each channel is connected to an independent gamma spectrometer to achieve multi-channel synchronous energy spectrum analysis.

[0031] Furthermore, the control center includes an industrial computer and a PLC collaborative control system. The industrial computer is equipped with a radiochemical purity calculation algorithm to automatically generate a test report that conforms to the pharmacopoeia format.

[0032] Furthermore, each test tube channel of the lead-shielded measurement chamber is equipped with a liquid level sensor to detect the injection volume of scintillation liquid in the test tube, ensuring measurement consistency.

[0033] The device's workflow is as follows:

[0034] S1: Initialization: The control center starts a self-test, all components are reset, and the unfolding cylinder is pre-loaded with unfolding agent.

[0035] S2: Marking stage: The transmission module conveys the chromatographic paper tape to the marking station, triggering the infrared sensor; the up-and-down telescopic module presses down the marking pen, and the back-and-forth moving module drives the marking pen to draw eleven dividing lines; after completion, the marking pen resets, and the chromatographic paper tape is conveyed to the spotting station.

[0036] S3: Spotting stage: The spotting component precisely adds radioactive drugs at the spotting point.

[0037] S4: Climbing stage: The first robotic arm uses the first suction cup to pick up the chromatographic paper strip and put it into the developing tank. After the solvent climbs to the center of the 11th segment, the first robotic arm takes out the chromatographic paper strip and lets it dry.

[0038] S5: Cutting stage: The blade of the second robotic arm cuts along the marked line, and after cutting off the chromatogram paper before the first segment, 11 segments remain.

[0039] S6: Measurement phase: The third suction cup of the fourth robotic arm picks up the chromatographic paper of 11 segments and puts them into 11 test tubes respectively; the third robotic arm uses the second suction cup to grab the test tubes and send them into the lead-shielded measurement chamber to measure the activity simultaneously.

[0040] S7: Data Processing and Output: The control center calculates the RCP and generates a report, indicating that the detection is complete.

[0041] Compared with the prior art, the present invention has the following advantages:

[0042] (1) Automation and efficiency. Through the coordinated operation of components such as marking, spotting, plate climbing, cutting, and measurement, the entire process of radiochemical purity detection of radiopharmaceuticals is automated, significantly reducing manual intervention and improving detection efficiency. The 11 independent channels of the lead-shielded measurement chamber can simultaneously measure the radioactivity of each section of chromatographic paper, avoiding the time-consuming problem of traditional segment-by-segment measurement.

[0043] (2) High precision and accuracy. Infrared sensors, vision-assisted positioning, and servo motor-driven motion modules ensure accurate positioning for marking, sampling, and cutting. The inner wall of the lead-shielded measurement chamber is coated with scintillator material, and each channel is connected to an independent gamma spectrometer, enabling high-precision multi-channel synchronous energy dispersive spectroscopy analysis.

[0044] (3) Radiation protection safety. The number of human contact with radioactive samples is reduced by using robotic arms and closed processes. Attached Figure Description

[0045] Figure 1 A schematic diagram of an automated device for detecting the radiochemical purity of radiopharmaceuticals;

[0046] Figure 2 This is a schematic diagram of the drive component.

[0047] Figure 3Schematic diagram of the marker component Figure 1 ;

[0048] Figure 4 Schematic diagram of the marker component Figure 2 ;

[0049] Figure 5 This is a schematic diagram of the structure of the spotting component;

[0050] Figure 6 Schematic diagram of the climbing board assembly Figure 1 ;

[0051] Figure 7 Schematic diagram of the climbing board assembly Figure 2 ;

[0052] Figure 8 This is a schematic diagram of the cutting component;

[0053] Figure 9 Schematic diagram of the measuring component Figure 1 ;

[0054] Figure 10 Schematic diagram of the measuring component Figure 2 ;

[0055] Figure 11 This is a schematic diagram of the chromatogram paper strip;

[0056] Figure 12 This is a flowchart of the eleven-stage method for radiochemical purity.

[0057] Reference numerals: 1-Chromatography paper strip; 2-Transmission module; 3-Placement platform; 4-Marking pen; 5-Up-down telescopic module; 6-Forward-backward moving module; 7-Infrared sensor; 8-Sampling assembly; 9-First robotic arm; 10-Developing cylinder; 11-First suction cup; 12-Second robotic arm; 13-Blade; 14-Third robotic arm; 15-Test tube; 16-Lead-shielded measuring chamber; 17-Second suction cup; 18-Fourth robotic arm; 19-Third suction cup. Detailed Implementation

[0058] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments. Component models, material names, connection structures, control methods, algorithms, and other features not explicitly described in this technical solution are considered common technical features disclosed in the prior art.

[0059] Example 1

[0060] This embodiment provides an automated device for detecting the radiochemical purity of radiopharmaceuticals, such as... Figure 1-10 As shown, it includes:

[0061] The marking component includes: a marking pen 4, a vertical telescopic module 5, a forward and backward movement module 6, and an infrared sensor 7; the vertical telescopic module 5 is connected to the marking pen 4, and the vertical telescopic module 5 drives the marking pen 4 to move vertically, while the forward and backward movement module 6 drives the marking pen 4 and the vertical telescopic module 5 to move forward and backward to draw lines; for example... Figure 11 As shown, this is the chromatogram paper strip 1 after the lines have been drawn.

[0062] The spotting component 8 is used to spot the sample at the spotting point on the chromatographic paper strip 1;

[0063] The climbing plate assembly includes a first robotic arm 9 and a developing cylinder 10. The first robotic arm 9 is provided with a first suction cup 11, which picks up the chromatographic paper strip 1 and places it into the developing cylinder 10 for climbing plate.

[0064] The cutting assembly includes a second robotic arm 12, which is equipped with twelve blades 13 to cut the chromatographic paper strip 1;

[0065] The measurement assembly includes a third robotic arm 14, a fourth robotic arm 18, test tubes 15, and a lead-shielded measurement chamber 16. Eleven test tubes 15 are provided, and the fourth robotic arm 18 is equipped with eleven third suction cups 19, each used to pick up a chromatographic paper strip 1 divided into eleven segments and place them into the test tubes 15. The third robotic arm 14 is equipped with a second suction cup 17, which is arc-shaped and mates with the outer surface of the test tubes 15. The third robotic arm 14 is used to pick up the test tubes 15 and place them into the lead-shielded measurement chamber 16. The lead-shielded measurement chamber 16 has eleven channels for placing the test tubes 15, enabling simultaneous measurement of the activity of each segment.

[0066] The drive assembly includes a transmission module 2 and a placement platform 3. The placement platform is used to place and fix the chromatographic paper tape 1, and the transmission module is used to drive the chromatographic paper tape 1 to move into each station.

[0067] The control center coordinates the timing of various components and performs motion control, communicating with each component via a bus (such as EtherCAT).

[0068] Coordinate the timing of each component: trigger actions such as marking, sampling, board climbing, cutting, and measurement according to the process;

[0069] Motion control: Adjusting motor speed, stroke, and synchronization (e.g., the coordination between a robotic arm and a conveyor belt);

[0070] Data acquisition: Record the activity data of lead-shielded measurement chamber 16 and automatically calculate RCP;

[0071] Safety monitoring: Real-time detection of radiation dose, emergency shutdown in case of abnormality.

[0072] The transmission module is a conveyor belt, which is driven by a motor.

[0073] In a specific embodiment, the forward and backward movement module 6 includes a lead screw slide mechanism driven by a stepper motor, and the lead screw slide mechanism includes a guide rail and a slider; the forward and backward movement module 6 drives the marking pen 4 to move along the width direction of the chromatographic paper tape 1, and cooperates with the up and down telescopic module 5 to complete the drawing of 11 marking lines.

[0074] In a specific implementation, the vertical telescopic module 5 is a synchronous belt transmission system driven by a servo motor. The servo motor receives instructions from the control center through the controller to achieve precise vertical displacement.

[0075] In a specific embodiment, the infrared sensor 7 is used to detect whether the chromatographic paper tape 1 has reached the marking station. When the chromatographic paper tape 1 blocks the infrared beam, the infrared sensor 7 sends a signal to the control center to trigger the marking component to operate.

[0076] In a specific embodiment, a pressure sensor is provided at the end of the upper and lower telescopic module 5 to monitor the contact pressure between the marker pen 4 and the chromatography paper tape 1 in real time.

[0077] In a specific embodiment, the spotting component 8 includes a micro-injection pump driven by a stepper motor.

[0078] In a specific implementation, the sampling component 8 includes a visual-assisted positioning unit, which is a 5MP industrial camera. Through the calculation of coordinates by the control center, it can achieve sampling at the sampling point.

[0079] In a specific embodiment, the inner walls of the 11 test tube channels of the lead-shielded measurement chamber 16 are coated with scintillator material, and each channel is connected to an independent gamma spectrometer to achieve multi-channel synchronous energy spectrum analysis.

[0080] In a specific implementation, the control center includes an industrial computer and a PLC collaborative control system. The industrial computer is equipped with a radiochemical purity calculation algorithm to automatically generate a test report that conforms to the pharmacopoeia format.

[0081] In a specific embodiment, each test tube channel of the lead-shielded measuring chamber 16 is equipped with a liquid level sensor to detect the amount of scintillation liquid injected into the test tube 15, ensuring measurement consistency.

[0082] like Figure 11 , 12 As shown, the working process of the device is as follows:

[0083] S1: Initialization: The control center starts a self-test, all components are reset, and the developing cylinder 10 is pre-loaded with developing agent.

[0084] S2: Marking stage: The transmission module 2 transmits the chromatographic paper tape 1 to the marking station, and the infrared sensor 7 is triggered; the vertical extension module 5 presses down the marking pen 4, and the forward and backward movement module 6 drives the marking pen 4 to draw eleven dividing lines; after completion, the marking pen 4 is reset, and the chromatographic paper tape 1 is transmitted to the spotting station.

[0085] S3: Spotting stage: Spotting component 8 precisely adds radioactive drugs at the spotting point.

[0086] S4: Climbing stage: The first robotic arm 9 uses the first suction cup 11 to pick up the chromatographic paper strip 1 and put it into the developing tank 10. After the solvent climbs to the center position of the 11th segment, the first robotic arm 9 takes out the chromatographic paper strip 1 and lets it dry.

[0087] S5: Cutting stage: The blade 13 of the second robotic arm 12 cuts along the marked line, and after cutting off the chromatographic paper before the first segment, 11 segments remain.

[0088] S6: Measurement stage: The third suction cup 19 of the fourth robotic arm 18 picks up the chromatographic paper of 11 segments and puts them into 11 test tubes respectively; the third robotic arm 14 uses the second suction cup 17 to grab the test tubes 15 and send them into the lead-shielded measurement chamber 16 to measure the activity simultaneously.

[0089] S7: Data Processing and Output: The control center calculates the RCP and generates a report, indicating that the detection is complete.

[0090] Components not described in detail in this embodiment are all existing components that can be purchased through public channels.

[0091] The above description of the embodiments is provided to enable those skilled in the art to understand and use the utility model. It will be apparent to those skilled in the art that various modifications can be easily made to these embodiments, and the general principles described herein can be applied to other embodiments without inventive effort. Therefore, the present utility model is not limited to the above embodiments, and any improvements and modifications made by those skilled in the art based on the disclosure of the present utility model without departing from its scope should be within the protection scope of the present utility model.

Claims

1. An automated device for detecting radiochemical purity of a radiopharmaceutical, characterized in that, include: The marking components include: a marking pen (4), a vertical telescopic module (5), a forward and backward moving module (6), and an infrared sensor (7); The vertical telescopic module (5) is connected to the marking pen (4). The vertical telescopic module (5) drives the marking pen (4) to move up and down. The forward and backward moving module (6) drives the marking pen (4) and the vertical telescopic module (5) to move forward and backward to draw lines. The spotting assembly (8) is used to spot the sample at the spotting point on the chromatographic paper strip (1); The climbing plate assembly includes a first robotic arm (9) and a developing cylinder (10). The first robotic arm (9) is provided with a first suction cup (11), which is used to pick up the chromatographic paper strip (1) and place it into the developing cylinder (10) for climbing plate. The cutting assembly includes a second robotic arm (12) with twelve blades (13) for cutting the chromatographic paper strip (1); The measuring assembly includes a third robotic arm (14), a fourth robotic arm (18), test tubes (15), and a lead-shielded measuring chamber (16). The test tubes (15) are provided with eleven segments, and the fourth robotic arm (18) is provided with eleven third suction cups (19), which are used to pick up the chromatographic paper strips (1) divided into eleven segments and place them into the test tubes (15). The third robotic arm (14) is provided with a second suction cup (17), which is arc-shaped and matches the outer surface of the test tubes (15). The third robotic arm (14) is used to pick up the test tubes (15) and place them into the lead-shielded measuring chamber (16). The lead-shielded measuring chamber (16) is provided with eleven channels for placing the test tubes (15), enabling simultaneous measurement of the activity of each segment. The drive assembly includes a transmission module (2) and a placement platform (3). The placement platform is used to place and fix the chromatographic paper tape (1), and the transmission module is used to drive the chromatographic paper tape (1) to move into each station. The control center coordinates the timing of various components and performs motion control, communicating with each component via a bus.

2. The automated device for detecting the radiochemical purity of radiopharmaceuticals according to claim 1, characterized in that, The forward and backward movement module (6) includes a lead screw slide mechanism driven by a stepper motor, and the lead screw slide mechanism includes a guide rail and a slider; the forward and backward movement module (6) drives the marking pen (4) to move along the width direction of the chromatographic paper tape (1), and cooperates with the up and down telescopic module (5) to complete the drawing of 11 marking lines.

3. The automated device for detecting the radiochemical purity of radiopharmaceuticals according to claim 1, characterized in that, The vertical telescopic module (5) is a synchronous belt drive system driven by a servo motor. The servo motor receives instructions from the control center through the controller to achieve vertical displacement.

4. The automated device for detecting the radiochemical purity of radiopharmaceuticals according to claim 1, characterized in that, The infrared sensor (7) is used to detect whether the chromatographic paper tape (1) has reached the marking station. When the chromatographic paper tape (1) blocks the infrared beam, the infrared sensor (7) sends a signal to the control center to trigger the marking component to operate.

5. An automated device for detecting the radiochemical purity of radiopharmaceuticals according to claim 1, characterized in that, The end of the upper and lower telescopic module (5) is equipped with a pressure sensor for real-time monitoring of the contact pressure between the marker pen (4) and the chromatographic paper tape (1).

6. An automated device for detecting the radiochemical purity of radiopharmaceuticals according to claim 1, characterized in that, The spotting assembly (8) includes a micro-injection pump driven by a stepper motor.

7. An automated device for detecting the radiochemical purity of radiopharmaceuticals according to claim 1, characterized in that, The dotting component (8) includes a vision-assisted positioning unit, which is a 5MP industrial camera, capable of dotting at the dotting point.

8. An automated device for detecting the radiochemical purity of radiopharmaceuticals according to claim 1, characterized in that, The inner walls of the 11 test tube channels of the lead-shielded measurement chamber (16) are coated with scintillator material, and each channel is connected to an independent gamma spectrometer to achieve multi-channel synchronous energy spectrum analysis.

9. An automated device for detecting the radiochemical purity of radiopharmaceuticals according to claim 1, characterized in that, The control center includes an industrial computer and a PLC collaborative control system. The industrial computer is equipped with a radiochemical purity calculation algorithm and automatically generates a test report that conforms to the pharmacopoeia format.

10. An automated device for detecting the radiochemical purity of radiopharmaceuticals according to claim 1, characterized in that, Each test tube channel of the lead-shielded measurement chamber (16) is equipped with a liquid level sensor to detect the amount of scintillation liquid injected into the test tube (15) and ensure measurement consistency.

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