A radioactive drug synthesis and sub-packaging production line

Abstract

The present application discloses a radiopharmaceutical synthesis and sub-packaging assembly line, which relates to the technical field of radiopharmaceutical preparation, including a synthesis hot chamber, a quality control chamber and a sub-packaging chamber for synthesizing a stock solution; the quality control chamber and the synthesis hot chamber are arranged side by side, and a first pipeline for transmitting the stock solution is arranged between the synthesis hot chamber and the quality control chamber, a running track and a detection equipment group for detecting the performance of the stock solution are arranged in the quality control chamber, and a filling bottle is detachably installed on the running track, and the filling bottle can move along the running track; the sub-packaging chamber is arranged on the side of the quality control chamber away from the synthesis hot chamber, and a second pipeline for transmitting the stock solution is arranged between the sub-packaging chamber and the quality control chamber. The present application has the effect of reducing the harm to the staff during the synthesis of radiopharmaceuticals.

Description

Technical Field

[0001] This application relates to the technical field of radioactive drug preparation, and particularly to a radioactive drug synthesis and packaging pipeline. Background Art

[0002] Currently, during the synthesis and production of radioactive drugs, a synthesis hot cell and a packaging room are required. Among them, the synthesis hot cell is an operating room for synthesizing radioactive drugs. A rotary accelerator is provided in the synthesis hot cell to achieve the synthesis of drugs and form the stock solution. Then, after the stock solution is taken out manually, the activity, pH value, clarity, and radioactive chemical concentration of the stock solution are detected manually. After passing the detection, it is then manually placed in the packaging room and packaged by a packaging instrument. Since the stock solution is a radioactive drug, during the process of manually taking, transporting, and detecting the stock solution, the radioactive drug will cause harm to the human body. Summary of the Invention

[0003] In order to reduce the harm to the staff during the synthesis of radioactive drugs, this application provides a radioactive drug synthesis and packaging pipeline.

[0004] This application provides a radioactive drug synthesis and packaging pipeline, adopting the following technical solutions:

[0005] A radioactive drug synthesis and packaging pipeline, comprising:

[0006] A synthesis hot cell for synthesizing the stock solution;

[0007] A quality control room, which is adjacent to the synthesis hot cell, and a first pipeline for transporting the stock solution is provided between the synthesis hot cell and the quality control room.

[0008] In the quality control room, an operating track and a detection equipment group for detecting the performance of the stock solution are provided. A holding bottle is detachably installed on the operating track, and the holding bottle can move along the operating track.

[0009] A packaging room, which is arranged on the side of the quality control room away from the synthesis hot cell, and a second pipeline for transporting the stock solution is provided between the packaging room and the quality control room.

[0010] By adopting the above technical solutions, for the radioactive stock solution synthesized in the synthesis hot cell, if it is taken out manually and detected manually, it is easy to cause damage to the health of the staff. Setting up a quality control room between the synthesis hot cell and the packaging room can form a radioactive drug synthesis and packaging pipeline. From the production of radioactive drugs to the packaging of radioactive drugs, there is no need for staff to contact radioactive drugs, and the detection before the production of radioactive drugs can be completed, making the production of radioactive drugs safer and harmless.

[0011] The radioactive drug stock solution manufactured in the synthesis hot room enters the quality control room through the first pipeline. After entering the quality control room, the running track drives the movement of the container bottle. During the movement of the container bottle, it passes through the detection equipment group, enabling the detection of various properties of the radioactive drug. After being detected by the detection equipment group in the quality control room, it enters the dispensing room through the second pipeline and is dispensed in the dispensing room, thus realizing the full process of radioactive drug production and dispensing.

[0012] Optionally, the detection equipment group includes an activity detector, a pH detector, a clarity detector, and a high-performance liquid chromatograph arranged in sequence along the running track of the running track. The pH detector is arranged above the running track, and the activity detector and the clarity detector are arranged below the running track.

[0013] By adopting the above technical solution, since the activity, pH value, clarity, and radioactive chemical concentration parameters of the stock solution need to be detected before the radioactive drug is dispensed, the above detection equipment is arranged in sequence along the running track, that is, the sequential detection of various parameters of the stock solution can be realized, and the above detection instruments are arranged above or below the running track according to the specific operation methods of various instruments.

[0014] Optionally, the running track includes drive shafts arranged at both ends of the quality control room. Two parallel and spaced drive cables are engaged on the drive shafts, and a fixing structure is arranged on the drive cables for installing the container bottle.

[0015] By adopting the above technical solution, the drive shafts drive the movement of the two drive cables engaged with the drive shafts, thereby driving the fixing structure to move along with the drive cables, so as to realize the movement of the container bottle along the drive cables. During the movement of the container bottle, it passes through the detection equipment group and completes the detection in sequence; setting two drive cables makes the fixing structure more stable to connect with the drive cables on the one hand, and makes it more convenient for the detection equipment group to detect the radioactive drug in the container bottle on the other hand.

[0016] Optionally, the fixing structure includes connecting rods fixed on the two drive cables. A fixing plate for detachably connecting with the container bottle is arranged between the two connecting rods, and the fixing plate is fixedly connected to one end of the two connecting rods far from the drive cables.

[0017] By adopting the above technical solution, two connecting rods are arranged, and a fixing plate is arranged between the two connecting rods, so that the container bottle can be fixed on the fixing plate, so that the container bottle can be arranged between the two connecting rods, thus facilitating the detection by the detection equipment group.

[0018] Optionally, a central rod is fixed in the container bottle. A threaded section is arranged at one end of the central rod far from the container bottle. The central rod passes through the fixing plate and is threadedly connected with the fixing plate.

[0019] By adopting the above technical solutions, the lifting and rotation of the holding bottle can be achieved. When detecting the activity of radioactive drugs, the radioactive drugs need to be placed in an activity detector for detection. By rotating the central rod, the lifting and lowering of the holding bottle can be realized, so that the holding bottle can be placed in or taken out of the activity detector; when performing clarity detection, the holding bottle needs to be rotated to observe the clarity of the stock solution, and rotating the central rod can also realize the rotation of the holding bottle.

[0020] Optionally, a clamping joint is fixed at one end of the central rod away from the fixed disk, and a polygonal groove is formed in the clamping joint.

[0021] By adopting the above technical solutions, the clamping joint is provided, and the polygonal groove is formed in the clamping joint, so that the staff can easily control the rotation of the central rod from outside the quality control room.

[0022] Optionally, a first operation hole and a second operation hole are respectively formed in the top wall of the quality control room above the activity detector and the clarity detector, and an operation rod for inserting into the polygonal groove can pass through both the first operation hole and the second operation hole.

[0023] By adopting the above technical solutions, when detecting the activity of radioactive drugs, the operation rod is inserted into the quality control room from the first operation hole and inserted into the polygonal groove, and the rotation of the central rod can be realized, so as to realize the lifting and lowering of the holding bottle; when detecting the clarity of radioactive drugs, the operation rod is also inserted into the quality control room from the second operation hole and inserted into the polygonal groove, and rotating the operation rod can realize the rotation of the holding bottle.

[0024] Optionally, protective covers are arranged in the first operation hole and the second operation hole.

[0025] By adopting the above technical solutions, when the first operation hole and the second operation hole are not needed, using the protective covers to close the first operation hole and the second operation hole can reduce the influence of radioactive drugs on the staff.

[0026] Optionally, the connecting rod includes a vertical rod and a horizontal rod. One end of the vertical rod is fixedly connected to the driving cable, and the other end is rotatably connected to the horizontal rod. A driving source for driving the horizontal rod to rotate along its own axis is arranged in the vertical rod.

[0027] By adopting the above technical solutions, after the radioactive drugs are detected by the detection equipment group, the radioactive drugs in the holding bottle need to be drained into the second pipeline. By using the driving source to drive the horizontal rod to rotate, the holding bottle fixedly connected to the horizontal rod can be driven to rotate, so as to realize the pouring of the radioactive drugs.

[0028] Optionally, the second pipeline slopes gradually downward from the quality control room to the dispensing room, and a liquid receiving tray communicating with the second pipeline is arranged in the quality control room, and the lowest point of the bottom wall of the liquid receiving tray is higher than the bottom wall of the second pipeline.

[0029] By adopting the above technical solution, when pouring the radioactive drug in the packaging bottle and introducing it into the second pipeline, first, a liquid receiving tray communicating with the second pipeline is arranged, so that the radioactive drug is not easily splashed during the pouring process, thus causing waste; in addition, the liquid receiving tray and the second pipeline are set with slopes so that the radioactive drug can be introduced into the second pipeline more smoothly.

[0030] To sum up, the present application includes at least one of the following beneficial effects:

[0031] 1. By arranging a quality control room, the detection of radioactive drugs can be automatically completed without manual handling of drugs, reducing the contact between staff and radioactive drugs, thereby reducing the harm of radioactive drugs to the health of staff;

[0032] 2. The production, detection and dispensing of radioactive drugs form a production line, which can improve production efficiency and make the production of radioactive drugs more convenient and fast;

[0033] 3. By arranging a fixed disk and a central rod, the lifting and rotation of the packaging bottle can be realized, so as to realize the activity detection and clarity detection of radioactive drugs, with a simple structure and convenient operation. Description of the Drawings

[0034] Figure 1 is the front view of the dispensing pipeline in the embodiment of the present application;

[0035] Figure 2 is the partial structural schematic diagram for showing the inside of the quality control room in the embodiment of the present application;

[0036] Figure 3 is the partial structural schematic diagram of the dispensing pipeline in the embodiment of the present application.

[0037] Description of the reference numerals: 1, synthesis hot cell; 2, quality control room; 21, running track; 211, drive shaft; 212, drive cable; 22, packaging bottle; 221, central rod; 23, connecting rod; 231, cross bar; 232, vertical rod; 24, fixed disk; 26, clamping joint; 261, polygonal groove; 27, first operation hole; 28, second operation hole; 29, protective cover; 3, dispensing room; 4, first pipeline; 5, second pipeline; 51, liquid receiving tray; 6, activity detector; 7, PH detector; 8, clarity detector; 9, chromatographic column; 10, operating rod. Detailed Embodiment

[0038] The following combines the attached Figures 1 - 3A further detailed description of the present application is provided.

[0039] A radioactive drug synthesis and sub-packaging production line disclosed in an embodiment of the present application, referring to Figure 1 , a radioactive drug synthesis and sub-packaging production line includes a synthesis hot cell 1, a quality control room 2, and a sub-packaging room 3 arranged in sequence. A first pipeline 4 for connecting the synthesis hot cell 1 and the quality control room 2 is provided between the synthesis hot cell 1 and the quality control room 2, and a second pipeline 5 for connecting the quality control room 2 and the sub-packaging room 3 is provided between the quality control room 2 and the sub-packaging room 3. The synthesis hot cell 1 is used to synthesize the stock solution of radioactive drugs. After the stock solution is synthesized, it is transported to the quality control room 2 through the first pipeline 4. A detection equipment group for detecting various properties of the stock solution, and a running track 21 for transporting the stock solution are arranged in the quality control room 2. After the stock solution is transported to the quality control room 2, it passes through the detection equipment group driven by the running track 21 to complete the detection of various properties. After the detection of the stock solution is completed, it is transported to the sub-packaging room 3 through the second pipeline 5, and the stock solution is sub-packaged in the sub-packaging room 3 to form finished radioactive drugs for treating patients.

[0040] Referring to Figure 1 , the detection equipment group includes an activity detector 6, a pH detector 7, a clarity detector 8, and a high performance liquid chromatograph arranged in sequence along the moving path of the running track 21. The pH detector 7 is arranged above the running track 21, the activity detector 6 and the clarity detector 8 are arranged below the running track 21, and the main unit of the high performance liquid chromatograph is arranged outside the quality control room 2.

[0041] Referring to Figure 2 , the running track 21 includes two driving shafts 211 arranged on two opposite side walls of the quality control room 2. Two parallel and spaced driving cables 212 are engaged on the driving shafts 211. A fixing structure is arranged on the driving cables 212. When the driving shafts 211 rotate, the driving cables 212 can be driven to move, thereby driving the fixing structure on the driving cables 212 to move. A holding bottle 22 is detachably arranged on the fixing structure. Specifically, the fixing structure includes two connecting rods 23, and the two connecting rods 23 are respectively fixed on the two driving cables 212. The connecting rod 23 includes a vertical rod 232 and a horizontal rod 231. The vertical rod 232 is used for fixedly connecting with the driving cable 212. The axial direction of the horizontal rod 231 is perpendicular to the axial direction of the vertical rod 232, and the horizontal rod 231 is hinged to the vertical rod 232. A driving source for driving the horizontal rod 231 to rotate around its own axis is arranged in the vertical rod 232.

[0042] Referring to Figure 1 and Figure 2, a fixing plate 24 is horizontally arranged between two cross bars 231. The fixing plate 24 is fixedly connected to both cross bars 231 at the same time, and a threaded hole is provided at the center of the fixing plate 24. A central rod 221 is vertically fixed inside the liquid storage bottle 22. One end of the central rod 221 is fixedly connected to the bottom wall of the liquid storage bottle 22, and the other end is provided with a threaded section. The threaded section passes through the threaded hole on the fixing plate 24 and is threadedly connected to the fixing plate 24. A clamping joint 26 is also fixed at the end of the central rod 221 provided with the threaded section, and a polygonal groove 261 is provided on the clamping joint 26. The fixing plate 24 is arranged directly above the bottle mouth of the liquid storage bottle 22, and the area of the fixing plate 24 is smaller than the bottle mouth of the liquid storage bottle 22. When detecting the PH value of the stock solution, the electrode head of the PH detector 7 can extend into the liquid storage bottle 22 from the gap between the fixing plate 24 and the liquid storage bottle 22 to realize the detection of the PH value of the stock solution.

[0043] Refer to Figure 1 and Figure 2 , when detecting the activity of the stock solution, it is necessary to lower the liquid storage bottle 22 into the detection chamber of the activity detector 6 for detection; when detecting the clarity of the stock solution, it is necessary to rotate the liquid storage bottle 22 one circle to facilitate the observation of the clarity of the stock solution inside the liquid storage bottle 22. When observing the clarity of the stock solution, it is possible to set an observation window on the side wall of the quality control room 2 for easy observation; it is also possible to set a camera in the quality control room 2 and transmit the picture to the computer screen for observation.

[0044] Refer to Figure 2 , the clamping joint 26 and the central rod 221 are set so that the staff can adjust the position of the liquid storage bottle 22 up and down from outside the quality control room 2, thereby realizing the detection of the activity of the stock solution; the central rod 221 is threadedly connected to the fixing plate 24, and by rotating the central rod 221, the liquid storage bottle 22 can be driven to rotate, thereby realizing the observation of the clarity of the stock solution.

[0045] Refer to Figure 2 and Figure 3 , a first operation hole 27 and a second operation hole 28 are provided on the top wall of the quality control room 2. The first operation hole 27 is arranged above the activity detector 6, and the second operation hole 28 is arranged above the clarity detector 8. An operation rod 10 is arranged in the first operation hole 27 and the second operation hole 28. The cross section of the operation rod 10 matches the cross section of the polygonal groove 261. When detecting the activity of the stock solution, insert the operation rod 10 into the quality inspection room from the first operation hole 27 and plug it into the polygonal groove 261. The staff rotates the operation rod 10 outside the quality inspection room to realize the lifting of the liquid storage bottle 22; when detecting the clarity of the stock solution, insert the operation rod 10 into the quality inspection room from the second operation hole 28 and plug it into the polygonal groove 261 to realize the rotation of the liquid storage bottle 22.

[0046] Refer to Figure 3, protective covers 29 are also provided in the first operation hole 27 and the second operation hole 28. When the clarity detection or activity detection is not carried out, the first operation hole 27 and the second operation hole 28 can be closed by using the protective covers 29 to reduce the impact of the radioactivity of the stock solution on the staff.

[0047] Refer to Figure 1 and Figure 2 , the operation of the drive shaft 211 is controlled by a program. The stop time and operation time of the drive shaft 211 are set according to the detection time of different detection instruments. The filled bottle 22 is moved along the drive cable 212 until all the detections of the stock solution are completed, and then the stock solution in the filled bottle 22 is discharged into the second pipeline 5, so that the stock solution enters the dispensing room 3 for dispensing.

[0048] Refer to Figure 3 , a liquid receiving tray 51 is provided at the end of the second pipeline 5 in the quality control room 2. When the pH value, activity and clarity of the stock solution are detected, the drive source is started through the program, and the drive source drives the cross bar 231 to rotate around its own axis, so as to realize the pouring of the stock solution in the filled bottle 22. When the high performance liquid chromatography is detected, the stock solution needs to flow through the chromatographic column 9. Therefore, the chromatographic column 9 is fixed in the liquid receiving tray 51. When the stock solution is poured into the filled bottle 22, the stock solution will pass through the chromatographic column 9 during the process of flowing into the second pipeline 5, so as to realize the detection of the radioactive chemical concentration of the stock solution. In addition, the liquid receiving tray 51 is provided, and the position and height of the liquid receiving tray 51 are reasonably set, so that the stock solution is not easy to spill when pouring, thus causing waste; in addition, the radioactive concentration of the stock solution can be more convenient to detect. The stock solution in the liquid receiving tray 51 enters the dispensing room 3 along the second pipeline 5 and is dispensed in the dispensing room 3. In order to make the stock solution enter the dispensing room 3 more smoothly through the second pipeline 5, the bottom walls of the second pipeline 5 and the liquid receiving tray 51 are gradually inclined downward from the quality control room 2 to the direction of the dispensing room 3, and the lowest point of the bottom wall of the liquid receiving tray 51 is higher than the highest point of the bottom wall of the second pipeline 5.

[0049] The implementation principle of a radioactive drug synthesis and dispensing production line according to an embodiment of the present application is as follows: by providing a quality control room 2 between the synthesis hot cell 1 and the dispensing room 3, the possibility of the staff contacting the radioactive drug during the production process of the radioactive drug is reduced. After the radioactive drug is generated in the synthesis hot cell 1, it enters the quality control room 2 through the first pipeline 4 and is introduced into the filled bottle 22. The drive shaft 211 rotates to drive the drive cable 212 to move, thereby driving the filled bottle 22 to move along the drive cable 212. During the movement of the filled bottle 22, it will successively pass through the activity detector 6, the pH detector 7, and the clarity detector 8.

[0050] When passing through the activity detector 6, the operating rod 10 is inserted into the polygonal groove 261 to drive the lifting of the liquid storage bottle 22, thereby realizing the activity detection of the stock solution; when the liquid storage bottle 22 runs below the pH detector 7, the electrode head of the pH detector 7 is driven to extend downward into the liquid storage bottle 22 to detect the pH value of the stock solution; after the pH value detection is completed, the clarity detection is carried out. The liquid storage bottle 22 is moved in front of the clarity detector 8, and the rotation of the liquid storage bottle 22 is realized by rotating the central rod 221, thereby realizing the observation of the clarity of the stock solution.

[0051] After the detection is completed, the cross bar 231 is rotated to realize the flipping of the liquid storage bottle 22, so as to pour the stock solution in the liquid storage bottle 22 into the liquid receiving tray 51. At this time, when the stock solution flows from the liquid receiving tray 51 into the second pipeline 5, it will pass through the chromatographic column 9, thereby completing the detection of the radiochemical concentration. Finally, the stock solution flows into the dispensing chamber 3 through the second pipeline 5 for dispensing. During the entire production process of the radioactive drug, the contact of the staff with the radioactive drug is reduced, and the impact of the radioactive drug on the staff during the production process is reduced, making the entire production process of the radioactive drug safer; through the pipeline of this application, the production efficiency of the radioactive drug can be improved, and the pollution of the radioactive drug during the handling process is also reduced without manual participation throughout the process.

[0052] The above are all the preferred embodiments of this application, and the protection scope of this application is not limited accordingly. Therefore, all equivalent changes made according to the structure, shape, and principle of this application shall be covered within the protection scope of this application.

Claims

1. A radioactive drug synthesis and sub-packaging production line, comprising: Synthesis hot chamber (1) for synthesizing the stock solution; Quality control chamber (2), the quality control chamber (2) is adjacent to the synthesis hot chamber (1), and a first pipeline (4) for transporting the stock solution is arranged between the synthesis hot chamber (1) and the quality control chamber (2), A running track (21) and a detection equipment group for detecting the performance of the stock solution are arranged in the quality control chamber (2). A containing bottle (22) is detachably installed on the running track (21), and the containing bottle (22) can move along the running track (21); Sub-packaging chamber (3), the sub-packaging chamber (3) is arranged on the side of the quality control chamber (2) away from the synthesis hot chamber (1), and a second pipeline (5) for transporting the stock solution is arranged between the sub-packaging chamber (3) and the quality control chamber (2); The detection equipment group includes an activity detector (6), a PH detector (7), a clarity detector (8) and a high performance liquid chromatograph arranged in sequence along the running track of the running track (21). The PH detector (7) is arranged above the running track (21), and the activity detector (6) and the clarity detector (8) are both arranged below the running track (21); The running track (21) includes drive shafts (211) arranged at both ends of the quality control chamber (2). Two parallel and spaced drive cables (212) are meshed on the drive shafts (211). A fixing structure is arranged on the drive cables (212), and the fixing structure is used to install the containing bottle (22); The fixing structure includes a connecting rod (23) fixed on two drive cables (212). A fixing plate (24) for detachably connecting with the containing bottle (22) is arranged between the two connecting rods (23). The fixing plate (24) is fixedly connected to one end of the two connecting rods (23) away from the drive cables (212); A central rod (221) is fixed in the containing bottle (22). A threaded section is arranged at one end of the central rod (221) away from the containing bottle (22). The central rod (221) passes through the fixing plate (24) and is threadedly connected with the fixing plate (24); A clamping joint (26) is fixed at one end of the central rod (221) away from the fixing plate (24). A polygonal groove (261) is opened in the clamping joint (26); First operation holes (27) and second operation holes (28) are respectively opened in the top wall of the quality control chamber (2) above the activity detector (6) and the clarity detector (8). Operation rods (10) for inserting into the polygonal groove (261) can pass through the first operation holes (27) and the second operation holes (28); 2. The radioactive drug synthesis and sub-packaging production line according to claim 1, wherein: Protective covers (29) are arranged in the first operation holes (27) and the second operation holes (28).

3. The radioactive drug synthesis and sub-packaging production line according to claim 1, wherein: The connecting rod (23) includes a vertical rod (232) and a horizontal rod (231). One end of the vertical rod (232) is fixedly connected to the drive cable (212), and the other end is rotatably connected to the horizontal rod (231). A drive source for driving the horizontal rod (231) to rotate along its own axis is arranged in the vertical rod (232).

4. The radioactive drug synthesis and sub-packaging production line according to claim 3, wherein: The second pipeline (5) slopes gradually downward in the direction from the quality control room (2) to the dispensing room (3), and a liquid receiving tray (51) is provided at the end of the second pipeline (5) in the quality control room (2), and the lowest point of the bottom wall of the liquid receiving tray (51) is higher than the bottom wall of the second pipeline (5).

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