Radiopharmaceutical subpackaging device and method

Abstract

The invention discloses a radiopharmaceutical subpackaging device and method. A flushing pipeline, a first liquid separation pipeline and a second liquid separation pipeline are connected through a three-way structure A, and one end of the flushing pipeline is connected with a flushing liquid container; one end of the first liquid separation pipeline is connected with the mother bottle; the second liquid distribution pipeline, the third liquid distribution pipeline and the fourth liquid distribution pipeline are connected through a three-way structure B, and one end of the third liquid distribution pipeline is connected with the intermediate container; the liquid driving part is used for controlling liquid to enter the middle container or be discharged from the middle container; the tail end pipeline, the fourth liquid separation pipeline and the waste liquid pipeline are connected through a three-way structure C; one end of the waste liquid pipeline is connected with a waste liquid collection container; one end of the target connecting pipeline is detachably connected with one end of the tail end pipeline; an intermediate container is disposed in the dose detector. When the medicine is subpackaged, the pipeline is emptied firstly, so that no air is left in the pipeline, an air-free subpackaging mode is realized, and the risk that air is mixed into a target container is reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of drug packaging, and in particular to a radioactive drug packaging device and method. Background Art

[0002] In the medical field, certain radioactive substances are particularly useful as contrast agents in imaging procedures or as therapeutic agents for certain diseases. For example, in positron emission tomography (PET) diagnosis, a certain dose of [18F]-fluorodeoxyglucose ([18F]-FDG) needs to be injected into the patient, and when treating thyroid diseases, a certain dose of 131I needs to be injected into the patient.

[0003] In the past, radioactive drugs were mainly packaged and obtained manually, which required medical staff to enter a protective space or reach into a protective lead box, use a syringe to extract the required amount of drugs from the radioactive drug packaging source liquid tank, and then measure the activity. If the activity measurement is within the allowable range, the drugs are placed in a radiation-proof box for transportation, and then diluted and injected when used.

[0004] With the advancement of technology, radioactive nuclear medicine filling instruments have emerged, but the filling accuracy of existing filling instruments is not high enough; and during the filling process, the air in the pipeline cannot be completely emptied. When the medicine is input into the target container (medicine bottle) to be filled, a certain amount of air is easily mixed in the medicine, affecting the filling quality of the medicine. Summary of the invention

[0005] The purpose of the present invention is to solve the deficiencies in the prior art and to provide a radiopharmaceutical packaging device and method.

[0006] The objective of the present invention is achieved through the following technical scheme: a radiopharmaceutical dispensing device, comprising a mother bottle, a flushing liquid container, an intermediate container, a waste liquid collection container, a target container, a flushing pipeline, a first liquid dispensing pipeline, a second liquid dispensing pipeline, a third liquid dispensing pipeline, a fourth liquid dispensing pipeline, a waste liquid pipeline, a terminal pipeline, and a target connecting pipeline; the volume of the intermediate container is variable; the flushing pipeline, the first liquid dispensing pipeline, and the second liquid dispensing pipeline are connected through a three-way structure A, one end of the flushing pipeline is connected to the flushing liquid container; one end of the first liquid dispensing pipeline is connected to the mother bottle;

[0007] The second liquid-distributing pipeline, the third liquid-distributing pipeline and the fourth liquid-distributing pipeline are connected through a three-way structure B, and one end of the third liquid-distributing pipeline is connected to the intermediate container; and a liquid driving component for controlling liquid to enter or be discharged from the intermediate container is also included;

[0008] The terminal pipeline, the fourth liquid separation pipeline and the waste liquid pipeline are connected through a three-way structure C, one end of the waste liquid pipeline is connected to the waste liquid collection container; one end of the target connection pipeline is detachably connected to one end of the terminal pipeline; the intermediate container is set in the dose detector.

[0009] Preferably, the liquid driving component includes a first liquid dispensing pump arranged on the second liquid dispensing pipeline and a second liquid dispensing pump arranged on the fourth liquid dispensing pipeline.

[0010] Preferably, a first bubble detection device is provided on the first liquid dispensing pipeline, and a second bubble detection device is provided on the target connecting pipeline.

[0011] Preferably, a weighing sensor for detecting the weight of the medicine in the intermediate container is also included.

[0012] Preferably, the intermediate container is a syringe; and the mother bottle is arranged in a protective device.

[0013] Preferably, it also includes a sub-packaging main body shell component and a consumable card sleeve, and the first liquid dispensing pipeline, the second liquid dispensing pipeline, the third liquid dispensing pipeline, the fourth liquid dispensing pipeline, the flushing pipeline, the terminal pipeline, and the waste liquid pipeline are all connected to the consumable card sleeve; the consumable card sleeve is detachably connected to the sub-packaging main body shell component.

[0014] Preferably, a target container support frame is provided in the outer shell component of the packaging main body; the target container is first placed in the protective cover, and then the target container and the protective cover are placed together on the target container support frame.

[0015] A method for packaging a radioactive drug comprises the following specific steps:

[0016] Step 1: Expel the air in the pipeline by flushing liquid in the flushing liquid container and fill the pipeline with flushing liquid;

[0017] Step 2: Calculate the specific activity of the radioactive drug according to the volume and total activity of the drug in the mother bottle, transfer the radioactive drug in the mother bottle into the intermediate container through the first dispensing pump, and stop the first dispensing pump when the dose detector detects that the total radiation dose of the drug in the intermediate container reaches the set dose value;

[0018] Step 3: using the second dispensing pump to transfer the drug in the intermediate container to the target container through the third dispensing pipeline, the fourth dispensing pipeline, the terminal pipeline, and the target connecting pipeline. After the transfer is completed, the third dispensing pipeline, the fourth dispensing pipeline, the terminal pipeline, and the target connecting pipeline are flushed with a flushing liquid to discharge the remaining drug in the pipeline into the target container;

[0019] Step 4: After the drug in the target container is packaged, the target container is separated from the terminal pipeline.

[0020] Preferably, the specific method of step one is as follows:

[0021] S1. First, adjust the three-way structure A and the three-way structure B so that the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline are in a connected state. The flushing liquid in the flushing liquid container enters the intermediate container through the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline under the action of the first liquid-dispensing pump, so that the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline are filled with flushing liquid; then adjust the three-way structure B and the three-way structure C so that the third liquid-dispensing pipeline, the fourth liquid-dispensing pipeline, and the waste liquid pipeline are in a connected state. The flushing liquid in the intermediate container enters the waste liquid collection container through the third liquid-dispensing pipeline, the fourth liquid-dispensing pipeline, and the waste liquid pipeline under the action of the second liquid-dispensing pump, and the third liquid-dispensing pipeline, the fourth liquid-dispensing pipeline, and the waste liquid pipeline are filled with flushing liquid;

[0022] S2, first adjust the three-way structure A and the three-way structure B, so that the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline are in a connected state, and the flushing liquid in the flushing liquid container enters the intermediate container through the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline under the action of the first liquid-dispensing pump; then adjust the three-way structure A so that the second liquid-dispensing pipeline is connected to the first liquid-dispensing pipeline, and the flushing liquid in the intermediate container is discharged into the mother bottle through the third liquid-dispensing pipeline, the second liquid-dispensing pipeline, and the first liquid-dispensing pipeline under the action of the first liquid-dispensing pump, and the first liquid-dispensing pipeline, the second liquid-dispensing pipeline, the third liquid-dispensing pipeline, and the flushing pipeline are filled with flushing liquid;

[0023] S3, connect the target container to the terminal pipeline through the target connecting pipeline; adjust the three-way structure A, the three-way structure B and the three-way structure C to connect the flushing pipeline, the second liquid dispensing pipeline, the fourth liquid dispensing pipeline, the terminal pipeline and the target connecting pipeline, and under the action of the first liquid dispensing pump or the second liquid dispensing pump, the flushing liquid in the flushing liquid container enters the target container through the flushing pipeline, the second liquid dispensing pipeline, the fourth liquid dispensing pipeline, the terminal pipeline and the target connecting pipeline, and fill the flushing pipeline, the second liquid dispensing pipeline, the fourth liquid dispensing pipeline, the terminal pipeline and the target connecting pipeline with the flushing liquid; then adjust the three-way structure B so that the fourth liquid dispensing pipeline is connected to the flushing pipeline; It is connected with the third dispensing pipe, and the flushing liquid in the target container is discharged into the intermediate container through the target connecting pipeline, the terminal pipeline, the fourth dispensing pipeline, and the third dispensing pipeline, and the target connecting pipeline, the terminal pipeline, the fourth dispensing pipeline, and the third dispensing pipeline are filled with flushing liquid; then the three-way structure B and the three-way structure C are switched to connect the third dispensing pipeline, the fourth dispensing pipeline and the waste liquid pipeline, and under the action of the second dispensing pump, the flushing liquid in the intermediate container is discharged into the waste liquid collecting container through the third dispensing pipeline, the fourth dispensing pipeline and the waste liquid pipeline, and the third dispensing pipeline, the fourth dispensing pipeline and the waste liquid pipeline are filled with flushing liquid.

[0024] Preferably, in step 2, when measuring the total activity of the drug in the mother bottle, first adjust the three-way structure A and the three-way structure B to connect the first liquid dispensing pipeline, the second liquid dispensing pipeline, and the third liquid dispensing pipeline, so that all the drugs in the mother bottle enter the intermediate container under the action of the first liquid dispensing pump, and detect the dose of the drug in the intermediate container by the dose detector to obtain the total activity of the drug in the mother bottle; after the measurement is completed, all the drugs in the intermediate container are pumped back into the mother bottle under the action of the first liquid dispensing pump;

[0025] Then adjust the three-way structure A and the three-way structure B to connect the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline, and under the action of the first liquid-dispensing pump, the flushing liquid in the flushing liquid container enters the intermediate container through the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline; then adjust the three-way structure A to connect the second liquid-dispensing pipeline with the first liquid-dispensing pipeline, and under the action of the first liquid-dispensing pump, the flushing liquid in the intermediate container is pumped back into the mother bottle, the intermediate container is emptied, and the first liquid-dispensing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline are filled with flushing liquid.

[0026] Preferably, in step 3, before separating the target container from the terminal pipeline, the drug in the first liquid separation pipeline is backwashed back into the mother bottle. The specific operation method is as follows:

[0027] The three-way structure A and the three-way structure B are adjusted to connect the flushing pipeline, the second liquid-dispensing pipeline and the third liquid-dispensing pipeline, and the flushing liquid in the flushing liquid container enters the intermediate container through the flushing pipeline, the second liquid-dispensing pipeline and the third liquid-dispensing pipeline under the action of the first liquid-dispensing pump; then the three-way structure A is adjusted to connect the second liquid-dispensing pipeline with the first liquid-dispensing pipeline, and the flushing liquid in the intermediate container flows into the mother bottle through the third liquid-dispensing pipeline, the second liquid-dispensing pipeline and the first liquid-dispensing pipeline through the first liquid-dispensing pump, thereby backwashing the medicine remaining in the first liquid-dispensing pipeline back into the mother bottle.

[0028] The beneficial effects of the present invention are:

[0029] 1. The present invention uses a variable-volume intermediate container to directly detect the dosage of the medicine to be packaged. The measurement deviation is only affected by the accuracy of the dosage detector itself, thereby ensuring the accuracy of packaging. The variable-volume intermediate container can ensure that the measured medicine is completely transferred to the target container, thereby reducing the residual medicine in the intermediate container.

[0030] 2. Before manually picking up the target container, the remaining radioactive drugs in the pipeline are returned to the lead tank mother bottle to achieve cold picking of the target device and reduce radiation exposure to the operator's hands.

[0031] 3. When the present invention is packaging the drug, the air in the pipeline is first evacuated so that no air remains in the pipeline, that is, there are only flushing fluid and radioactive drugs in the pipeline, and no air is used as a conveying medium, thereby realizing an air-free packaging mode, reducing the risk of air in the pipeline, and reducing the risk of air mixing into the target container.

[0032] 4. This filling method transfers the radioactive drug to the intermediate container through the flushing liquid to measure the activity, replacing the activity measurement lifting mechanism, and realizing the deactivation measurement lifting mechanism, making the overall structure of the filling device simpler and more compact, which is convenient for placement in an existing protective space (such as a hot room).

[0033] 5. In the present invention, the pipeline consumables are centrally arranged on the consumable ferrule, and the consumable ferrule is detachably connected to the sub-packaging main body shell component through the first ferrule locking device and the second ferrule locking device; when the above-mentioned pipeline consumables need to be replaced, it is only necessary to remove the consumable ferrule, and the above-mentioned pipeline consumables can be replaced at one time, which greatly facilitates the convenience of replacing consumables. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 It is a schematic diagram of pipeline connection of the present invention.

[0035] Figure 2 It is a schematic diagram of the entity structure of the present invention.

[0036] Figure 3 It is a schematic diagram of the structure of the consumable card sleeve in the present invention.

[0037] In the figure: 1, protective device, 2, medicine, 3, mother bottle, 4, first dispensing pipeline, 5, first ventilation needle tube, 6, flushing liquid container, 7, flushing pipeline, 8, three-way structure A, 9, first bubble detection device, 10, first dispensing pump, 11, second dispensing pipeline, 12, three-way structure B, 13, dose detector, 14, intermediate container, 15, third dispensing pipeline, 16, second dispensing pump, 17, fourth dispensing pipeline, 18, three-way structure C, 19, terminal pipeline, 20, first two bubble detection devices, 21. waste liquid collection container, 22. waste liquid pipeline, 23. second ventilation needle tube, 24. quick-screw connector, 26. target container, 27. target connecting pipeline, 28. control unit, 29. weighing sensor, 30. subpackaging main body shell component, 31. flushing liquid container bracket, 32. display screen, 33. target container support frame, 34. waste liquid protection door, 35. consumable card sleeve, 36. first card sleeve locking device, 37. second card sleeve locking device, 38. protective sleeve. DETAILED DESCRIPTION

[0038] The following will be combined with the accompanying drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field belong to the scope of protection of the present invention.

[0039] Those skilled in the art should understand that, in the disclosure of the present invention, the orientation or position relationship indicated by the terms "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc. are based on the orientation or position relationship shown in the drawings, which are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation. Therefore, the above terms should not be understood as limiting the present invention.

[0040] It is to be understood that the term "one" should be understood as "at least one" or "one or more", that is, in one embodiment, the number of an element may be one, while in another embodiment, the number of the element may be multiple, and the term "one" should not be understood as a limitation on the quantity.

[0041] like Figure 1 As shown, a radiopharmaceutical packaging device includes a control unit 28, a mother bottle 3, a flushing liquid container 6, an intermediate container 14, a waste liquid collection container 21, a target container 26, a flushing pipeline 7, a first liquid dispensing pipeline 4, a second liquid dispensing pipeline 11, a third liquid dispensing pipeline 15, a fourth liquid dispensing pipeline 17, a waste liquid pipeline 22, a terminal pipeline 19, and a target connecting pipeline 27; the volume of the intermediate container 14 is variable; the flushing pipeline 7, the first liquid dispensing pipeline 4, and the second liquid dispensing pipeline 11 are connected through a three-way structure A8, one end of the flushing pipeline 7 is connected to the flushing liquid container 6; one end of the first liquid dispensing pipeline 4 is connected to the third liquid dispensing pipeline 15, and the fourth liquid dispensing pipeline 17 is connected to the waste liquid pipeline 22. Connect to the mother bottle 3; the second liquid-dispensing pipeline 11, the third liquid-dispensing pipeline 15 and the fourth liquid-dispensing pipeline 17 are connected by a three-way structure B12, and one end of the third liquid-dispensing pipeline 15 is connected to the intermediate container; it also includes a liquid driving component for controlling the liquid to enter or be discharged from the intermediate container; the terminal pipeline 19, the fourth liquid-dispensing pipeline 17 and the waste liquid pipeline 22 are connected by a three-way structure C18, and one end of the waste liquid pipeline 22 is connected to the waste liquid collection container 21; one end of the target connection pipeline 27 is detachably connected to one end of the terminal pipeline 19; the intermediate container is arranged in the dose detector 13.

[0042] The flushing liquid container 6 is used to contain the flushing liquid, and the flushing liquid is used to flush the pipeline. In this embodiment, the flushing liquid is selected from standard saline. In this embodiment, the liquid driving component includes a first liquid dispensing pump 10 arranged on the second liquid dispensing pipeline 11 and a second liquid dispensing pump 16 arranged on the fourth liquid dispensing pipeline 17.

[0043] The three-way structure A8, the three-way structure B12, and the three-way structure C18 are used to switch the connection state of the pipeline. Among them, the three-way structure A8 can switch the connection state between the flushing pipeline 7, the first liquid separation pipeline 4, and the second liquid separation pipeline 11, the three-way structure B12 is used to switch the connection state between the second liquid separation pipeline 11, the third liquid separation pipeline 15, and the fourth liquid separation pipeline 17, and the three-way structure C18 is used to switch the connection state between the terminal pipeline 19, the fourth liquid separation pipeline 17 and the waste liquid pipeline 22. In this embodiment, the three-way structure A8, the three-way structure B12, and the three-way structure C18 are all electrically controlled three-way structures, and are all controlled by the control unit 28.

[0044] The first liquid dispensing pump 10 and the second liquid dispensing pump 16 are both liquid pumps, which are used to drive the medicine 2 or the flushing liquid to flow in the pipeline. The first liquid dispensing pump 10 and the second liquid dispensing pump 16 are both controlled by the control unit 28 .

[0045] One end of the terminal pipeline 19 is provided with a quick-screw connector 24, one end of the target connection pipeline 27 is connected to the target container 26, and the other end is detachably connected to the terminal pipeline 19 through the quick-screw connector 24, and the connection or disconnection between the target container 26 and the terminal pipeline 19 can be conveniently achieved through the quick-screw connector 24. Among them, the target container 26 is used to contain the packaged medicine 2. The target container 26 is set in a protective cover 38. The protective cover 38 is made of lead or tungsten and is used to isolate the radiation of the medicine 2. The target container 26 can be a vial or a syringe.

[0046] The volume of the intermediate container 14 is variable. In this embodiment, the intermediate container 14 is a syringe. When the external medicine 2 or flushing liquid is injected into the intermediate container 14, the medicine 2 or flushing liquid will push the piston of the syringe to move, so that the volume increases; conversely, when the medicine 2 or flushing liquid in the syringe is drawn out, negative pressure is formed inside the syringe, and the piston moves by the negative pressure, so that the volume inside the syringe decreases.

[0047] The mother bottle 3 is arranged in the protective device 1. The protective device 1 is made of lead or tungsten and is used to isolate the radiation of the medicine 2. The mother bottle 3 is provided with a first ventilation needle tube 5. The waste liquid collection container 21 is provided with a second ventilation needle tube 23.

[0048] The dose detector 13 is used to detect the radiation dose of the medicine 2, thereby determining the total activity of the medicine 2. In this embodiment, the total activity of the medicine 2 is represented by the radiation dose of the medicine 2. A protective layer is provided outside the dose detector 13, and the protective layer is used to isolate the radiation of the medicine 2 in the intermediate container.

[0049] A first bubble detection device 9 is provided on the first liquid dispensing pipeline 4, and a second bubble detection device 20 is provided on the target connecting pipeline 27. The first bubble detection device 9 and the second bubble detection device 20 are used to detect whether there are bubbles (air) in the pipeline.

[0050] The present invention further comprises a weighing sensor 29 for detecting the weight of the medicine 2 in the intermediate container. The weighing sensor 29 is used to measure the weight of the medicine 2 in the intermediate container 14.

[0051] The weighing sensor is arranged above the intermediate container and connected to the intermediate container. The weighing sensor may be a cantilever weighing sensor, and the weighing sensor is used to measure the weight of the liquid in the intermediate container and to detect the reliability of the system packaging.

[0052] like Figure 2-3 As shown, the present invention also includes a sub-packaging main body shell component 30 and a consumable card sleeve 35. The first liquid dispensing pipeline 4, the second liquid dispensing pipeline 11, the third liquid dispensing pipeline 15, the fourth liquid dispensing pipeline 17, the flushing pipeline 7, the terminal pipeline 19, and the waste liquid pipeline 22 are all connected to the consumable card sleeve 35; the consumable card sleeve 35 is detachably connected to the sub-packaging main body shell component 30.

[0053] The first liquid dispensing pipeline 4, the second liquid dispensing pipeline 11, the third liquid dispensing pipeline 15, the fourth liquid dispensing pipeline 17, the flushing pipeline 7, the terminal pipeline 19, and the waste liquid pipeline 22 are all disposable consumables, and need to be replaced after each subpackaging operation or replaced every day. In the present invention, by centrally arranging the above-mentioned pipeline consumables on the consumable ferrule 35, the consumable ferrule 35 is detachably connected to the subpackaging main body shell component 30 through the first ferrule locking device 36 and the second ferrule locking device 37; when the above-mentioned pipeline consumables need to be replaced, only the consumable ferrule 35 needs to be removed, and the above-mentioned pipeline consumables can be replaced at the same time at one time, which greatly facilitates the convenience of replacing consumables.

[0054] The control device, the first liquid dispensing pump 10 and the second liquid dispensing pump 16 are all arranged in a dispensing main body shell component 30 , and a display screen 32 is arranged on the outer side of the dispensing main body shell component 30 .

[0055] A target container support frame 33 is provided in the subpackaging main body shell component 30. The target container is first placed in the protective cover 38, and then the target container and the protective cover 38 are placed together on the target container 26 support frame. A radiation detection device is provided on the target container support frame 33. The radiation detection device is located outside the protective cover 38 and is used to detect the radiation around the target container 26. A warning light is provided on the radiation detection device. The warning light displays different colors of light to determine whether the radiation around the target container 26 is within a safe range. For example, when the warning light emits green light, it indicates that the radiation around the target container 26 is below the safe value; if the warning light emits red light, it indicates that the radiation around the target container 26 exceeds the safe value. This can effectively ensure the safety of the operation.

[0056] A flushing liquid container bracket 31 is provided on the subpackaging main body shell component 30 , and the flushing liquid container 6 is hung on the flushing liquid container bracket 31 .

[0057] A waste liquid protection door 34 is provided on the sub-packaging main body shell component 30 , and the waste liquid collection container 21 is arranged on the inner side of the waste liquid protection door 34 on the sub-packaging main body shell component 30 .

[0058] In this embodiment, the three-way structure A, the three-way structure B and the three-way structure C all use three-way valves.

[0059] A method for packaging a radioactive drug comprises the following specific steps:

[0060] Step 1: Expel the air in the pipeline by the flushing liquid in the flushing liquid container 6, and fill the pipeline with the flushing liquid;

[0061] Step 2: Calculate the specific activity of the radioactive drug 2 according to the volume and total activity of the drug 2 in the mother bottle 3, and transfer the radioactive drug 2 in the mother bottle 3 into the intermediate container 14 through the first dispensing pump 10. When the dose detector 13 detects that the total radiation dose of the drug 2 in the intermediate container 14 reaches the set dose value, the first dispensing pump 10 stops working;

[0062] Among them, the total activity of drug 2 in the mother bottle 3 can be obtained by measurement, and the volume of drug 2 in the mother bottle 3 can be known in advance. When calculating the specific activity of drug 2, the total activity of drug 2 is divided by the volume of drug 2 to obtain the specific activity of drug 2.

[0063] Step 3: The drug 2 in the intermediate container 14 is transferred to the target container 26 through the third liquid dispensing pipeline 15, the fourth liquid dispensing pipeline 17, the terminal pipeline 19, and the target connecting pipeline 27 by the second liquid dispensing pump 16. After the transfer is completed, the third liquid dispensing pipeline 15, the fourth liquid dispensing pipeline 17, the terminal pipeline 19, and the target connecting pipeline 27 are flushed with a flushing liquid to discharge the remaining drug 2 in the pipeline into the target container 26;

[0064] Step 4: After the medicine 2 in the target container 26 is packaged, the target container 26 is separated from the terminal pipeline 19 .

[0065] The specific method of step one is as follows:

[0066] S1, first adjust the three-way structure A8 and the three-way structure B12, so that the flushing pipeline 7, the second liquid dispensing pipeline 11, and the third liquid dispensing pipeline 15 are in a connected state, the first liquid dispensing pump 10 is turned on, and the second liquid dispensing pump 16 is turned off. Under the action of the first liquid dispensing pump 10, the flushing liquid in the flushing liquid container passes through the flushing pipeline 7, the second liquid dispensing pipeline 11, and the third liquid dispensing pipeline 15 into the intermediate container 14, so that the flushing pipeline 7, the second liquid dispensing pipeline 11, and the third liquid dispensing pipeline 15 are filled with flushing liquid; then adjust The three-way structure B12 and the three-way structure C18 are connected to make the third liquid-distributing pipeline 15, the fourth liquid-distributing pipeline 17 and the waste liquid pipeline 22 in a connected state, the first liquid-distributing pump 10 is turned off, and the second liquid-distributing pump 16 is turned on. The flushing liquid in the intermediate container 14 enters the waste liquid collecting container 21 through the third liquid-distributing pipeline 15, the fourth liquid-distributing pipeline 17 and the waste liquid pipeline 22 under the action of the second liquid-distributing pump 16, and the third liquid-distributing pipeline 15, the fourth liquid-distributing pipeline 17 and the waste liquid pipeline 22 are filled with the flushing liquid;

[0067] S2, first adjust the three-way structure A8 and the three-way structure B12, so that the flushing pipeline 7, the second liquid-dispensing pipeline 11, and the third liquid-dispensing pipeline 15 are in a connected state, the first liquid-dispensing pump 10 is turned on, and the second liquid-dispensing pump 16 is turned off, and the flushing liquid in the flushing liquid container enters the intermediate container 14 through the flushing pipeline 7, the second liquid-dispensing pipeline 11, and the third liquid-dispensing pipeline 15 under the action of the first liquid-dispensing pump 10; then adjust the three-way structure A8 to make the second liquid-dispensing pipeline 11 and the first liquid-dispensing pipeline 4 connected, the first liquid-dispensing pump 10 is turned on, and the second liquid-dispensing pump 16 is turned off, and the flushing liquid in the intermediate container 14 is discharged into the mother bottle 3 through the third liquid-dispensing pipeline 15, the second liquid-dispensing pipeline 11, and the first liquid-dispensing pipeline 4 under the action of the first liquid-dispensing pump 10, and the first liquid-dispensing pipeline 4, the second liquid-dispensing pipeline 11, the third liquid-dispensing pipeline 15, and the flushing pipeline 7 are filled with flushing liquid;

[0068] S3, connect the target container 26 to the terminal pipeline 19 through the target connecting pipeline 27; adjust the three-way structure A8, the three-way structure B12 and the three-way structure C18, so that the flushing pipeline 7, the second liquid dispensing pipeline 11, the fourth liquid dispensing pipeline 17, the terminal pipeline 19, and the target connecting pipeline 27 are connected, and one of the first liquid dispensing pump 10 or the second liquid dispensing pump 16 is turned on, and under the action of the first liquid dispensing pump 10 or the second liquid dispensing pump 16, the flushing liquid in the flushing liquid container 6 enters the target container 26 through the flushing pipeline 7, the second liquid dispensing pipeline 11, the fourth liquid dispensing pipeline 17, the terminal pipeline 19, and the target connecting pipeline 27, and the flushing pipeline 7, the second liquid dispensing pipeline 11, the fourth liquid dispensing pipeline 17, the terminal pipeline 19, and the target connecting pipeline 27 are filled with flushing liquid; then adjust the three-way structure B12 so that the fourth liquid dispensing pipeline 17 is connected to the flushing pipeline 7, the second liquid dispensing pipeline 11, the fourth liquid dispensing pipeline 17, the terminal pipeline 19, and the target connecting pipeline 27. The tube is connected with the third liquid dispensing tube, and the flushing liquid in the target container 26 is discharged into the intermediate container 14 through the target connecting pipeline 27, the terminal pipeline 19, the fourth liquid dispensing pipeline 17, and the third liquid dispensing pipeline 15, and the target connecting pipeline 27, the terminal pipeline 19, the fourth liquid dispensing pipeline 17, and the third liquid dispensing pipeline 15 are filled with flushing liquid; then the three-way structure B12 and the three-way structure C18 are switched to connect the third liquid dispensing pipeline 15, the fourth liquid dispensing pipeline 17 and the waste liquid pipeline 22, the first liquid dispensing pump 10 is closed, and the second liquid dispensing pump 16 is turned on. Under the action of the second liquid dispensing pump 16, the flushing liquid in the intermediate container 14 is discharged into the waste liquid collecting container 21 through the third liquid dispensing pipeline 15, the fourth liquid dispensing pipeline 17 and the waste liquid pipeline 22, and the third liquid dispensing pipeline 15, the fourth liquid dispensing pipeline 17 and the waste liquid pipeline 22 are filled with flushing liquid.

[0069] Through the above operation, all pipelines can be filled with flushing liquid, and the air in all pipelines can be completely removed to avoid air residue in the pipelines, thereby preventing air from mixing into the medicine 2 during the subsequent packaging process.

[0070] Specifically, in step 2, when measuring the total activity of the drug 2 in the mother bottle 3, there are two methods: manual measurement and measurement by the device. The manual measurement method is to detect the radiation dose of the drug 2 in the mother bottle 3 manually with the help of a dose detection device other than the device. This method requires manual operation, and the operator has a certain radiation risk.

[0071] After obtaining the total activity and volume of the drug through manual measurement, the reliability of the system is tested. The specific test steps are as follows:

[0072] N1: Calculate the specific activity of the radioactive drug in the mother bottle 3 according to the known parameters, and first deliver a certain proportion of the drug (such as 50% of the expected dose) according to the specific activity. In this process, adjust the three-way structure A8 to connect the first liquid dispensing pipe 4 with the second liquid dispensing pipeline 11, adjust the three-way structure B12 to connect the second liquid dispensing pipeline 11 with the third liquid dispensing pipeline 15, and the first liquid dispensing pump 10 is activated to extract the predetermined dose of the drug in the mother bottle into the intermediate container, and then the first liquid dispensing pump 10 stops running;

[0073] N2: Adjust the three-way structure A8 to connect the flushing pipe with the second liquid dispensing pipeline 11, and start the first filling pump 10. A certain volume of flushing liquid is delivered by the first filling pump 10 to deliver all the drugs remaining in the pipeline to the intermediate container 14. The total radiation dose of the drug is detected by the dose detector. The theoretical weight of the liquid in the current intermediate container is calculated by the radiation dose, the specific activity of the drug and the volume of the input flushing liquid. The actual weight of the liquid in the current intermediate container is directly measured by the weighing sensor. The theoretical weight and the actual weight are compared to test the reliability of the system. If the theoretical weight is consistent with the actual weight, it indicates that the filling accuracy of the system is reliable.

[0074] N3: Repeat steps N1 and N2 to transfer all the remaining doses of the medicine to the intermediate container 14, so that the total radiation dose of the medicine in the intermediate container 14 reaches the expected dose; then the medicine can be packaged in the next step.

[0075] The measurement method of the present device uses the dose detector 13 provided in the present device to detect the dose of the drug 2 in the mother bottle 3. This method avoids close contact between the operator and the mother bottle 3 and reduces the risk of radiation. The specific method of the measurement method of the present device is as follows: first adjust the three-way structure A8 and the three-way structure B12 to connect the first liquid separation pipeline, the second liquid separation pipeline, and the third liquid separation pipeline, turn on the first liquid separation pump 10, and turn off the second liquid separation pump 16. Under the action of the first liquid separation pump 10, all the drugs 2 in the mother bottle 3 enter the intermediate container 14, and the dose detector 13 is used to detect the dose of the drug 2 in the intermediate container 14 to obtain the total activity of the drug 2 in the mother bottle 3; after the measurement is completed, all the drugs 2 in the intermediate container 14 are drawn back to the mother bottle 3 under the action of the first liquid separation pump 10; then adjust the three-way structure A8 and the three-way structure B12 to connect the flushing pipeline 7, the second liquid separation pipeline, and the third liquid separation pipeline. The liquid pipeline 11 and the third liquid-dispensing pipeline 15 are connected, the first liquid-dispensing pump 10 is turned on, and the second liquid-dispensing pump 16 is turned off. Under the action of the first liquid-dispensing pump 10, the flushing liquid in the flushing liquid container 6 enters the intermediate container 14 through the flushing pipeline 7, the second liquid-dispensing pipeline 11, and the third liquid-dispensing pipeline 15; then the three-way structure A8 is adjusted to make the second liquid-dispensing pipeline 11 connected to the first liquid-dispensing pipeline 4, the first liquid-dispensing pump 10 is turned on, and the second liquid-dispensing pump 16 is turned off. Under the action of the first liquid-dispensing pump 10, the flushing liquid in the intermediate container 14 is pumped back into the mother bottle 3, the intermediate container 14 is emptied, and the first liquid-dispensing pipeline 4, the second liquid-dispensing pipeline 11, and the third liquid-dispensing pipeline 15 are filled with flushing liquid.

[0076] After completing the measurement process of the device, the system is then tested for reliability, that is, the above steps N1-N3 are repeated.

[0077] It is worth mentioning that when the first liquid dispensing pump 10 and the second liquid dispensing pump 16 are delivering medicine or flushing liquid, the control unit will record the amount of liquid delivered by the first liquid dispensing pump 10 and the second liquid dispensing pump 16 each time.

[0078] In step 3, before separating the target container 26 from the terminal pipeline 19, the drug 2 in the first liquid separation pipeline 4 is backwashed back into the mother bottle 3. The specific operation method is as follows:

[0079] The three-way structure A8 and the three-way structure B12 are adjusted to connect the flushing pipeline 7, the second liquid-dispensing pipeline 11 and the third liquid-dispensing pipeline 15, the first liquid-dispensing pump 10 is turned on, and the second liquid-dispensing pump 16 is turned off. The flushing liquid in the flushing liquid container 6 enters the intermediate container 14 through the flushing pipeline 7, the second liquid-dispensing pipeline 11 and the third liquid-dispensing pipeline 15 under the action of the first liquid-dispensing pump 10; then the three-way structure A8 is adjusted to connect the second liquid-dispensing pipeline 11 and the first liquid-dispensing pipeline 4, the first liquid-dispensing pump 10 runs in reverse, and the flushing liquid in the intermediate container 14 flows into the mother bottle 3 through the third liquid-dispensing pipeline 15, the second liquid-dispensing pipeline 11 and the first liquid-dispensing pipeline 4 through the first liquid-dispensing pump 10, thereby backwashing the medicine 2 remaining in the first liquid-dispensing pipeline 4 back into the mother bottle 3.

[0080] The present invention backwashes the medicine 2 in the first liquid dispensing pipeline 4 back into the mother bottle 3, so that when the operator takes the target container 26 away, there is no liquid medicine in all the pipelines, and the liquid medicine flows back into the mother bottle 3, thereby reducing the radiation damage to the operator. When the target container 26 is taken away, the target connecting pipeline 27 is disconnected from the terminal pipeline 19, and the target container 26 is connected to the target connecting pipeline 27 and taken away together.

[0081] The present invention has the following advantages:

[0082] 1. The present invention uses a variable-volume intermediate container to directly detect the dosage of the medicine to be packaged. The measurement deviation is only affected by the accuracy of the dosage detector itself, thereby ensuring the accuracy of packaging. The variable-volume intermediate container can ensure that the measured medicine is completely transferred to the target container, thereby reducing the residual medicine in the intermediate container.

[0083] 2. Before manually picking up the target container, the remaining radioactive drugs in the pipeline are returned to the lead tank mother bottle to achieve cold picking of the target device and reduce radiation exposure to the operator's hands.

[0084] 3. When the present invention is packaging the drug, the air in the pipeline is first evacuated so that no air remains in the pipeline, that is, there are only flushing fluid and radioactive drugs in the pipeline, and no air is used as a conveying medium, thereby realizing an air-free packaging mode, reducing the risk of air in the pipeline, and reducing the risk of air mixing into the target container.

[0085] 4. This filling method transfers the radioactive drug to the intermediate container through the flushing liquid to measure the activity, replacing the activity measurement lifting mechanism, and realizing the deactivation measurement lifting mechanism, making the overall structure of the filling device simpler and more compact, which is convenient for placement in an existing protective space (such as a hot room).

[0086] 5. In the present invention, the pipeline consumables are centrally arranged on the consumable ferrule, and the consumable ferrule is detachably connected to the sub-packaging main body shell component through the first ferrule locking device and the second ferrule locking device; when the above-mentioned pipeline consumables need to be replaced, it is only necessary to remove the consumable ferrule, and the above-mentioned pipeline consumables can be replaced at one time, which greatly facilitates the convenience of replacing consumables.

[0087] The present invention is not limited to the above-mentioned optimal implementation mode. Anyone can derive other various forms of products under the inspiration of the present invention. However, no matter what changes are made in the shape or structure, all technical solutions that are the same or similar to those of the present application fall within the protection scope of the present invention.

Claims

1. A radiopharmaceutical packaging device, characterized in that: It includes a mother bottle, a flushing liquid container, an intermediate container, a waste liquid collection container, a target container, a flushing pipeline, a first liquid-dispensing pipeline, a second liquid-dispensing pipeline, a third liquid-dispensing pipeline, a fourth liquid-dispensing pipeline, a waste liquid pipeline, a terminal pipeline, and a target connecting pipeline; the volume of the intermediate container is variable; the flushing pipeline, the first liquid-dispensing pipeline, and the second liquid-dispensing pipeline are connected through a three-way structure A, one end of the flushing pipeline is connected to the flushing liquid container; one end of the first liquid-dispensing pipeline is connected to the mother bottle; The second liquid-distributing pipeline, the third liquid-distributing pipeline and the fourth liquid-distributing pipeline are connected through a three-way structure B, and one end of the third liquid-distributing pipeline is connected to the intermediate container; and a liquid driving component for controlling liquid to enter or be discharged from the intermediate container is also included; The terminal pipeline, the fourth liquid separation pipeline and the waste liquid pipeline are connected through a three-way structure C, one end of the waste liquid pipeline is connected to the waste liquid collection container; one end of the target connection pipeline is detachably connected to one end of the terminal pipeline; the intermediate container is set in the dose detector.

2. A radiopharmaceutical packaging device according to claim 1, characterized in that: The liquid driving component includes a first liquid dispensing pump disposed on the second liquid dispensing pipeline and a second liquid dispensing pump disposed on the fourth liquid dispensing pipeline.

3. A radiopharmaceutical packaging device according to claim 1, characterized in that: The first liquid dispensing pipeline is provided with a first bubble detection device, and the target connecting pipeline is provided with a second bubble detection device.

4. A radiopharmaceutical packaging device according to claim 1, characterized in that: A weighing sensor for detecting the weight of the drug in the intermediate container is also included.

5. A radiopharmaceutical packaging device according to claim 1, characterized in that: The intermediate container is a syringe; the mother bottle is arranged in a protective device.

6. A radiopharmaceutical packaging device according to claim 1, characterized in that: It also includes a sub-packaging main body shell component and a consumable card sleeve. The first liquid dispensing pipeline, the second liquid dispensing pipeline, the third liquid dispensing pipeline, the fourth liquid dispensing pipeline, the flushing pipeline, the terminal pipeline, and the waste liquid pipeline are all connected to the consumable card sleeve; the consumable card sleeve is detachably connected to the sub-packaging main body shell component.

7. A radiopharmaceutical packaging device according to claim 6, characterized in that: A target container support frame is arranged inside the outer shell component of the subpackaging main body; the target container is first placed inside the protective cover, and then the target container and the protective cover are placed together on the target container support frame.

8. A method for packaging radiopharmaceuticals, based on the radiopharmaceutical packaging device according to claim 2, characterized in that: The specific steps include: Step 1: Expel the air in the pipeline by flushing liquid in the flushing liquid container and fill the pipeline with flushing liquid; Step 2: Calculate the specific activity of the radioactive drug according to the volume and total activity of the drug in the mother bottle, transfer the radioactive drug in the mother bottle into the intermediate container through the first dispensing pump, and stop the first dispensing pump when the dose detector detects that the total radiation dose of the drug in the intermediate container reaches the set dose value; Step 3: using the second dispensing pump to transfer the drug in the intermediate container to the target container through the third dispensing pipeline, the fourth dispensing pipeline, the terminal pipeline, and the target connecting pipeline. After the transfer is completed, the third dispensing pipeline, the fourth dispensing pipeline, the terminal pipeline, and the target connecting pipeline are flushed with a flushing liquid to discharge the remaining drug in the pipeline into the target container; Step 4: After the drug in the target container is packaged, the target container is separated from the terminal pipeline.

9. A method for packaging a radiopharmaceutical according to claim 8, characterized in that: The specific method of step one is as follows: S1. First, adjust the three-way structure A and the three-way structure B so that the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline are in a connected state. The flushing liquid in the flushing liquid container enters the intermediate container through the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline under the action of the first liquid-dispensing pump, so that the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline are filled with flushing liquid; then adjust the three-way structure B and the three-way structure C so that the third liquid-dispensing pipeline, the fourth liquid-dispensing pipeline, and the waste liquid pipeline are in a connected state. The flushing liquid in the intermediate container enters the waste liquid collection container through the third liquid-dispensing pipeline, the fourth liquid-dispensing pipeline, and the waste liquid pipeline under the action of the second liquid-dispensing pump, and the third liquid-dispensing pipeline, the fourth liquid-dispensing pipeline, and the waste liquid pipeline are filled with flushing liquid; S2, first adjust the three-way structure A and the three-way structure B, so that the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline are in a connected state, and the flushing liquid in the flushing liquid container enters the intermediate container through the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline under the action of the first liquid-dispensing pump; then adjust the three-way structure A so that the second liquid-dispensing pipeline is connected to the first liquid-dispensing pipeline, and the flushing liquid in the intermediate container is discharged into the mother bottle through the third liquid-dispensing pipeline, the second liquid-dispensing pipeline, and the first liquid-dispensing pipeline under the action of the first liquid-dispensing pump, and the first liquid-dispensing pipeline, the second liquid-dispensing pipeline, the third liquid-dispensing pipeline, and the flushing pipeline are filled with flushing liquid; S3, connect the target container to the terminal pipeline through the target connecting pipeline; adjust the three-way structure A, the three-way structure B and the three-way structure C to connect the flushing pipeline, the second liquid dispensing pipeline, the fourth liquid dispensing pipeline, the terminal pipeline and the target connecting pipeline, and under the action of the first liquid dispensing pump or the second liquid dispensing pump, the flushing liquid in the flushing liquid container enters the target container through the flushing pipeline, the second liquid dispensing pipeline, the fourth liquid dispensing pipeline, the terminal pipeline and the target connecting pipeline, and fill the flushing pipeline, the second liquid dispensing pipeline, the fourth liquid dispensing pipeline, the terminal pipeline and the target connecting pipeline with the flushing liquid; then adjust the three-way structure B so that the fourth liquid dispensing pipeline is connected to the flushing pipeline; It is connected with the third dispensing pipe, and the flushing liquid in the target container is discharged into the intermediate container through the target connecting pipeline, the terminal pipeline, the fourth dispensing pipeline, and the third dispensing pipeline, and the target connecting pipeline, the terminal pipeline, the fourth dispensing pipeline, and the third dispensing pipeline are filled with flushing liquid; then the three-way structure B and the three-way structure C are switched to connect the third dispensing pipeline, the fourth dispensing pipeline and the waste liquid pipeline, and under the action of the second dispensing pump, the flushing liquid in the intermediate container is discharged into the waste liquid collecting container through the third dispensing pipeline, the fourth dispensing pipeline and the waste liquid pipeline, and the third dispensing pipeline, the fourth dispensing pipeline and the waste liquid pipeline are filled with flushing liquid.

10. A method for packaging radiopharmaceuticals according to claim 8, characterized in that: In step 2, when measuring the total activity of the drug in the mother bottle, first adjust the three-way structure A and the three-way structure B to connect the first liquid dispensing pipeline, the second liquid dispensing pipeline, and the third liquid dispensing pipeline, so that all the drugs in the mother bottle enter the intermediate container under the action of the first liquid dispensing pump, and detect the dose of the drug in the intermediate container by the dose detector to obtain the total activity of the drug in the mother bottle; after the measurement is completed, all the drugs in the intermediate container are pumped back into the mother bottle under the action of the first liquid dispensing pump; Then adjust the three-way structure A and the three-way structure B to connect the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline, and under the action of the first liquid-dispensing pump, the flushing liquid in the flushing liquid container enters the intermediate container through the flushing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline; then adjust the three-way structure A to connect the second liquid-dispensing pipeline with the first liquid-dispensing pipeline, and under the action of the first liquid-dispensing pump, the flushing liquid in the intermediate container is pumped back into the mother bottle, the intermediate container is emptied, and the first liquid-dispensing pipeline, the second liquid-dispensing pipeline, and the third liquid-dispensing pipeline are filled with flushing liquid.

11. A method for packaging radioactive drugs according to claim 8, characterized in that: In step 3, before separating the target container from the terminal pipeline, the drug in the first dispensing pipeline is backwashed back into the mother bottle. The specific operation method is as follows: The three-way structure A and the three-way structure B are adjusted to connect the flushing pipeline, the second liquid-dispensing pipeline and the third liquid-dispensing pipeline, and the flushing liquid in the flushing liquid container enters the intermediate container through the flushing pipeline, the second liquid-dispensing pipeline and the third liquid-dispensing pipeline under the action of the first liquid-dispensing pump; then the three-way structure A is adjusted to connect the second liquid-dispensing pipeline with the first liquid-dispensing pipeline, and the flushing liquid in the intermediate container flows into the mother bottle through the third liquid-dispensing pipeline, the second liquid-dispensing pipeline and the first liquid-dispensing pipeline through the first liquid-dispensing pump, thereby backwashing the medicine remaining in the first liquid-dispensing pipeline back into the mother bottle.

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