Pharmaceutical production system, isolator, and pharmaceutical production method

Abstract

The application discloses a medicine production system, an isolation cabinet and a medicine production method. The medicine production system comprises a first reaction container, a second reaction container, a first conveying element, a first driving mechanism and a second driving mechanism. The first conveying element is connected with the first reaction container and the second reaction container. The first driving mechanism and the first conveying element are matched to drive the first reactant to flow into the second reaction container along the first conveying element to perform synthesis. The second driving mechanism and the second conveying element are matched to drive the synthesized medicine to flow into a dispensing container along the second conveying element. The second conveying element is connected with a needle assembly and the dispensing container. The needle assembly has a first position and a second position relative to the second reaction container when the needle assembly is inserted into the second reaction container. The medicine production system can realize automatic synthesis and dispensing of medicine, improve the efficiency and precision of medicine synthesis and dispensing, reduce the contact between medical staff and medicine in the application scene of synthesis and dispensing of radioactive medicine, and reduce the radioactive harm of medicine to medical staff.

Description

Cross-references to related applications

[0001] This application is based on and claims priority to Chinese Patent Application No. 202511071034.4, filed on July 31, 2025, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This invention relates to the field of pharmaceutical manufacturing technology, and in particular to a pharmaceutical manufacturing system, an isolation cabinet, and a pharmaceutical manufacturing method. Background Technology

[0003] In related technologies, manual drug production by medical staff affects production efficiency. Furthermore, the development of drugs for tumor diagnosis and treatment is rapid, with emerging radioactive drugs constantly appearing. Radiopharmaceuticals refer to a special class of drugs containing radionuclides for medical diagnosis and treatment; they are compounds or biological agents labeled with radionuclides used for medical diagnosis or treatment within the body. Currently, most radiopharmaceuticals are manually labeled with nuclides by medical staff, but manual operation has low precision, carries the risk of error, and emits radiation, potentially causing radiation damage to medical personnel. Summary of the Invention

[0004] This invention aims to at least solve one of the technical problems existing in the prior art. Therefore, one object of this invention is to provide a drug production system that can improve the accuracy and efficiency of drug synthesis and packaging, and in applications involving the synthesis and packaging of radiopharmaceuticals, reduce the contact between medical personnel and drugs, thus significantly reducing the radioactive hazards posed by drugs to medical personnel.

[0005] The present invention further proposes an isolation cabinet having the above-mentioned drug production system.

[0006] The present invention further proposes a drug production method for the above-mentioned drug production system.

[0007] A drug manufacturing system according to an embodiment of the present invention includes: A first reaction container and a second reaction container, wherein the first reaction container is used to store the first reactant and the second reaction container is used to store the second reactant; A first conveyor, which connects a first reaction vessel and a second reaction vessel; A drug synthesis apparatus, comprising a first driving mechanism and a first conveying member, which cooperate to drive a first reactant to flow along the first conveying member into a second reaction vessel for synthesis; Dispensing containers are used to store the synthesized drug. The second delivery unit is used to deliver the synthesized drug; A drug dispensing device, comprising a second driving mechanism, wherein the second driving mechanism and a second conveying member cooperate to drive the synthesized drug to flow into a dispensing container along the second conveying member; The pin assembly and the second conveyor communicate with the pin assembly and the dispensing container. The pin assembly is adapted to be inserted into or removed from the second reaction container. When the pin assembly is inserted into the second reaction container, the pin assembly has a first position and a second position relative to the second reaction container. When the pin assembly is in the first position, the first reactant in the first reaction vessel flows into the second reaction vessel, and the gas in the second reaction vessel is discharged through the pin assembly. With the needle assembly in the second position, the synthesized drug flows into the dispensing container through the needle assembly, and the gas outside the second reaction container flows into the second reaction container through the needle assembly.

[0008] The drug production system according to embodiments of the present invention enables automated drug synthesis, particularly in radiopharmaceutical synthesis applications. This reduces contact between medical personnel and the drugs, significantly lowering the radioactive hazard to healthcare workers. Furthermore, the automated synthesis allows for pre-setting reactant parameters, accurately controlling the reactant delivery rate, mixing ratio, and dispensing volume, ensuring the stability and consistency of the synthesized drug quality. This avoids human error and improves the precision and efficiency of drug synthesis. Additionally, by injecting different drugs into the system and utilizing the drug synthesis apparatus, different drugs can be synthesized, enhancing the system's versatility and applicability. This allows the system to meet the synthesis needs of various types and specifications of drugs. It also reduces contact between medical personnel and the drugs in radiopharmaceutical synthesis applications, significantly lowering the radioactive hazard to healthcare workers.

[0009] According to some embodiments of the present invention, the drug production system further includes: a first drive module, which can drive the second reaction vessel to move so as to mix the first reactant and the second reactant within the second reaction vessel.

[0010] According to some embodiments of the present invention, the first drive module is configured to drive the second reaction vessel to reciprocate along a first direction, the first direction being the height direction of the drug production system.

[0011] According to some embodiments of the present invention, the drug production system further includes: a support base having a placement space having an open end for placing a second reaction container; when the second reaction container is placed in the placement space, the neck and mouth of the second reaction container are exposed from the open end of the placement space.

[0012] According to some embodiments of the present invention, the drug synthesis apparatus further includes: a heating device disposed within a support base, the heating device being used to heat a second reaction vessel; and / or the support base, the second reaction vessel, and the needle assembly being arranged along a first direction, with the second reaction vessel located between the support base and the needle assembly, the first direction being the height direction of the drug production system.

[0013] According to some embodiments of the present invention, the drug synthesis apparatus further includes: A heat dissipation device is used to cool the second reaction vessel. The drug production system also includes: a first drive module, which can drive the movement of the second reaction vessel, and a heat dissipation device fixed to the first drive module.

[0014] According to some embodiments of the present invention, at least a portion of the heat dissipation device and the second reaction vessel are located on the same side of the first drive module along a first direction, the first direction being the height direction of the drug production system.

[0015] According to some embodiments of the present invention, the heat dissipation device has a blower, through which the heat dissipation device blows air to the second reaction vessel.

[0016] According to some embodiments of the present invention, the air outlet extends along the depth direction of the second reaction vessel.

[0017] According to some embodiments of the present invention, the drug synthesis apparatus further includes: a first shielding and radiation protection structure, which may surround the second reaction vessel, and the first shielding and radiation protection structure is constructed in an arc shape.

[0018] According to some embodiments of the present invention, the first radiation shielding structure includes at least one shielding part that is closer to the operator than the second reaction vessel.

[0019] According to some embodiments of the present invention, the drug synthesis apparatus further includes: a second drive module connected to a first shielding and radiation protection structure, the second drive module being used to drive the first shielding and radiation protection structure to move so that the first shielding and radiation protection structure remains around the second reaction vessel.

[0020] According to some embodiments of the present invention, the second drive module can drive the first shielding radiation protection structure to move in the same direction as the second reaction vessel.

[0021] According to some embodiments of the present invention, the second drive module can drive the first shielding radiation protection structure to move synchronously with the second reaction container.

[0022] According to some embodiments of the present invention, the drug dispensing device further includes: a multi-port member, a second conveying member communicating with the needle assembly and the multi-port member, the second conveying member communicating with the dispensing container through the multi-port member, and the multi-port member being movable to communicate with or separate from the dispensing container.

[0023] According to some embodiments of the present invention, when the first reactant flows from the first reaction vessel into the second reaction vessel, the multi-port component is separated from the dispensing container; When the synthesized drug flows into the dispensing container, the multi-port is connected to the dispensing container.

[0024] According to some embodiments of the present invention, the drug dispensing device further includes: a second shielding and radiation protection structure for placing the dispensing container, the second shielding and radiation protection structure forming a shielding groove with one end open for placing the dispensing container.

[0025] According to some embodiments of the present invention, the pin assembly includes: a first pin and a second pin, wherein the length of the first pin is greater than the length of the second pin; In the first position, the first pin is inserted into the second reaction vessel and remains separated from the prepared solvent in the second reaction vessel during the synthesis process, so that the gas in the second reaction vessel can be discharged through the first pin. In the second position, both the first and second pins of the insert assembly are inserted into the second reaction vessel, and the first pin is inserted into the synthesized drug so that the synthesized drug is discharged through the first pin. The second pin is kept separate from the synthesized drug during the dispensing process so that gas outside the second reaction vessel can enter the second reaction vessel through the second pin.

[0026] In some embodiments of the present invention, the first pin and the second pin are independent of each other.

[0027] According to some embodiments of the present invention, the inner diameter of the second pin is larger than the outer diameter of the first pin, the second pin is sleeved outside the first pin, and the first pin and the second pin are spaced apart to form a gap between the first pin and the second pin, so that gas outside the second reaction vessel can enter the second reaction vessel through the gap.

[0028] According to some embodiments of the present invention, during the synthesis process, both the first driving mechanism and the second driving mechanism are working and the multi-port is separated from the dispensing container, so that when the first reactant in the first reaction container flows into the second reaction container, the gas in the second reaction container is discharged through the pin assembly and the multi-port.

[0029] An isolation cabinet according to an embodiment of the present invention includes: The drug production system is the drug production system described above. The cabinet houses the drug production system.

[0030] According to an embodiment of the present invention, a drug manufacturing method is applied to the above-described drug manufacturing system. The drug manufacturing method includes the following steps: S1: The second reaction container is moved relative to the pin assembly by the first drive module so that the pin assembly moves to a first position. At the first position, the first pin of the pin assembly is inserted into the second reaction container. S2: The first peristaltic pump drives the reagent to flow through the nuclide generator and the first reactant washed off flows into the second reaction vessel through the first pipeline. It mixes with the second reactant in the second reaction vessel to form the preparation solvent. The gas in the second reaction vessel is discharged through the first needle. During the washing process, the first needle is separated from the preparation solvent in the second reaction vessel. S3: Drive the second reaction vessel to move away from the pin assembly via the first drive module; S4: The second reaction container is driven to reciprocate along the first direction by the first driving module to mix the prepared solvent in the second reaction container, and the synthetic drug is formed in the second reaction container; S5: The second reaction container continues to move relative to the pin assembly through the first drive module so that the pin assembly moves to the second position. At the second position, the first pin is inserted into the synthetic drug in the second reaction container, and the second pin of the pin assembly is separated from the preparation solvent. S6: The third drive module drives the multi-port component to connect with the dispensing container, and the second peristaltic pump drives the synthetic drug to be delivered into the dispensing container through the first needle, the second pipeline and the multi-port component. S7: After setting the dispensing activity or volume parameters, the second peristaltic pump stops working when the preset amount of synthetic drug in the dispensing container is reached. S8: The third drive module drives the multi-channel component to separate from the dispensing container and places the dispensing container in the first activity detection device for activity detection. Once the activity detection value reaches the standard, the dispensing is completed in one go.

[0031] According to some embodiments of the present invention, the step further includes, or is included simultaneously with, the movement of the second reaction vessel driven by the first drive module: The second drive module drives the first shielded radiation protection structure and the second reaction container to move synchronously.

[0032] According to some embodiments of the present invention, step S4, after shaking to prepare the solvent, further includes the following steps: S4.1: Drive the second reaction vessel toward the support base via the first drive module so that the second reaction vessel moves into the placement space of the support base; S4.2: Place the second reaction vessel in the placement space and let it stand for a period of time to wait for drug synthesis.

[0033] According to some embodiments of the present invention, step S4, after shaking to prepare the solvent, further includes the following steps: S4(a): Drive the second reaction vessel toward the support base via the first drive module so that the second reaction vessel moves into the placement space of the support base; S4(b): The heating device inside the support base heats the second reaction vessel; S4(c): The first drive module drives the second reaction vessel to move away from the support base; S4(d): During the movement, the heat dissipation device cools the second reaction vessel.

[0034] According to some embodiments of the present invention, after connecting the multi-port component to the dispensing container in step S6, a venting process is further included, which includes the following steps: S6.1: A portion of the synthesized drug from the second reaction vessel is delivered to the dispensing container via a second peristaltic pump to purge the air from the second pipeline; S6.2: The multi-channel component is separated from the packaging container by the third drive module; S6.3: Replace with a new dispensing container; S6.4: The multi-channel component is connected to the new dispensing container via the third drive module, and the synthetic drug in the second reaction container is delivered to the new dispensing container via the second peristaltic pump.

[0035] According to some embodiments of the present invention, prior to step S1, a preparation process for the drug production system may be included, specifically comprising the following steps: S0.1: Self-inspection of the drug production system; S0.2: Add the required amount of drug powder to the second reaction container, inject water for injection into the second reaction container, shake thoroughly to dissolve, and then install the second reaction container on the support base; S0.3: Connect the reagent preparation to the generator inlet of the radionuclide generator; S0.4: Connect one end of the first pipeline to the generator outlet of the nuclide generator, install at least a portion of the first pipeline in the first extrusion chamber of the first peristaltic pump, and connect the other end of the first pipeline to the second reaction vessel; S0.5: Connect one end of the second pipeline to the first pin, and install at least a portion of the second pipeline into the second extrusion groove of the second peristaltic pump, and connect the other end of the second pipeline to the multi-port, while keeping the multi-port disconnected from the dispensing container; S0.6: Install the pin assembly into place.

[0036] According to some embodiments of the present invention, the following steps may be included after the preparation process and before step S1: starting the first peristaltic pump and the second peristaltic pump so that during the rinsing process, the gas in the second reaction vessel is discharged through the first needle, the second pipeline and the multi-port.

[0037] According to some embodiments of the present invention, before step S1, the following step may be included: starting the heating device for preheating.

[0038] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0039] The above and / or additional aspects and advantages of the present invention will become apparent and readily understood from the description of the embodiments taken in conjunction with the following drawings, in which: Figure 1 This is a schematic diagram of the isolation cabinet according to an embodiment of the present invention; Figure 2 This is a partial structural diagram of the internal structure of the isolation cabinet according to an embodiment of the present invention; Figure 3 This is a schematic diagram of the structure of a drug production system according to an embodiment of the present invention; Figure 4 This is a schematic diagram of a first embodiment of the pin assembly of the present invention; Figure 5 This is a schematic diagram of a second embodiment of the pin assembly of the present invention; Figure 6 This is a schematic diagram of the interconnected modules of the drug production system according to an embodiment of the present invention; Figure 7A This is a partial structural diagram of the drug production system according to an embodiment of the present invention after removing a portion of its structure; Figure 7B This is a schematic diagram of another partial structure of the drug production system according to an embodiment of the present invention after removing some of its components; Figure 7C This is a schematic diagram of another partial structure of the drug production system according to an embodiment of the present invention after removing some of its components; Figure 8 This is a schematic flowchart of a drug production method according to an embodiment of the present invention; Figure 9 This is a schematic flowchart of a drug synthesis method according to an embodiment of the present invention.

[0040] Figure label: Drug production system 100; Drug synthesis apparatus 10; first conveying component 11; first pipeline 111; first drive mechanism 12; first peristaltic pump 121; first drive module 13; second drive module 14; third drive module 15; first reaction vessel 16; gripper 17; Pin assembly 20; First pin 21; Second pin 22; Generator inlet 212; Generator outlet 213; First extrusion tank 214; Nuclide generator 215; First shielding radiation protection structure 23; shielding part 231; heating device 24; heat dissipation device 25; air outlet 251; Drug dispensing device 30; Second conveying component 31; multi-channel component 311; mounting base 312; second pipeline 313; Second drive mechanism 32; second extrusion groove 321; second peristaltic pump 322; Second shielding radiation protection structure 33; Packaging container 34; Support base 40; Placement space 41; Second reaction vessel 50; First activity detection device 51; Isolation cabinet 200; through hole 201; shielding cover 202; controller 203. Detailed Implementation

[0041] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0042] The following is for reference. Figures 1-9 A drug production system 100, an isolation cabinet 200, and a drug production method according to embodiments of the present invention are described.

[0043] A drug production system 100 according to an embodiment of the present invention includes: a first reaction container 16 and a second reaction container 50, wherein the first reaction container 16 is used to store a first reactant and the second reaction container 50 is used to store a second reactant; The first conveyor 11 is connected to the first reaction vessel 16 and the second reaction vessel 50; The drug synthesis apparatus 10 includes a first drive mechanism 12, which cooperates with a first conveyor 11 to drive a first reactant to flow along the first conveyor 11 into a second reaction vessel 50 for synthesis. The pin assembly 20 is adapted to be inserted into the second reaction vessel 50. When the first driving mechanism 12 drives the first reactant to flow into the second reaction vessel 50, the pin assembly 20 remains separated from the solvent disposed in the second reaction vessel 50.

[0044] In one example of the present invention, both the first reaction container 16 and the second reaction container 50 can be vials. The first reaction container 16 is used to store a first reactant (which can be a radioactive isotope), and the second reaction container 50 is used to store a second reactant. The first conveying member 11 can be a first pipeline 111, which connects the first reaction container 16 and the second reaction container 50 to convey the first reactant in the first reaction container 16 to the second reaction container 50 via the first conveying member 11.

[0045] The drug synthesis apparatus 10 is used to synthesize drugs. The apparatus includes a first driving mechanism 12, which can be a first peristaltic pump 121. The first driving mechanism 12 and a first conveying member 11 cooperate to drive a first reactant along the first conveying member 11 into a second reaction container 50 for synthesis, thereby enabling drug synthesis. As an example of the present invention, the first reactant in the first reaction container 16 can be hydrochloric acid reagent, and the second reactant in the second reaction container 50 can be a drug injection solution. However, the present invention is not limited to this; both the first and second reactants can be reasonably selected according to actual conditions.

[0046] The insert assembly 20 is adapted to be inserted into the second reaction container 50. When the first drive mechanism 12 drives the first reactant to flow into the second reaction container 50, the insert assembly 20 remains separated from the preparation solvent (which may include the first reactant, the second reactant, and a mixed solution of the first and second reactants) inside the second reaction container 50. This allows gas inside the second reaction container 50 to be discharged through the insert assembly 20, thereby balancing the internal and external pressures of the second reaction container 50 and reducing the risk of rupture or reduced sealing of the second reaction container 50. Specifically, an imbalance in the internal and external pressures of the second reaction container 50 may cause the first drive mechanism 12 to idle and malfunction. Furthermore, an imbalance in the internal and external pressures of the second reaction container 50 may cause it to rupture or deteriorate its sealing. If the reactant solution inside the second reaction container 50 is a radioactive liquid, it may expose workers to a radiation environment, affecting their health.

[0047] The insertion needle assembly 20 enables the gas pressure inside the second reaction container 50 to be balanced, allowing the gas inside the second reaction container 50 to be smoothly discharged from the second reaction container 50 without the need to introduce other exhaust needles, thus simplifying the operation steps of drug synthesis and reducing the cost of drug synthesis.

[0048] Therefore, the drug production system 100 enables automated drug synthesis, especially in radiopharmaceutical synthesis applications, reducing contact between medical personnel and drugs and significantly lowering the radiation hazard to them. Furthermore, automated drug synthesis allows for pre-setting reactant parameters, accurately controlling reactant delivery rates, mixing ratios, and dispensing volumes, ensuring the stability and consistency of the synthesized drug quality, avoiding human error, and thus improving the precision and efficiency of drug synthesis. Additionally, by injecting different drugs into the drug production system 100 and using the drug synthesis device 10, different drugs can be synthesized, improving the versatility and applicability of the drug production system 100, making it suitable for synthesizing various types and specifications of drugs. This also reduces contact between medical personnel and drugs in radiopharmaceutical synthesis applications, significantly lowering the radiation hazard to them.

[0049] According to some embodiments of the present invention, such as Figure 3 As shown, the drug production system 100 further includes a first drive module 13, which can drive the second reaction container 50 to move so that the first reactant and the second reactant in the second reaction container 50 are mixed.

[0050] The first drive module 13 may include a motor, a lead screw module, a gripper 17 (which may be a mechanical gripper or a pneumatic gripper), etc. The first drive module 13 can drive the second reaction container 50 to move (such as rotation, shaking, translation, etc.) to promote the full mixing of the first reactant and the second reactant in the second reaction container 50, thereby enabling the automatic synthesis of drugs.

[0051] According to some embodiments of the present invention, the first drive module 13 is configured to drive the second reaction vessel 50 to reciprocate along a first direction, the first direction being the height direction of the drug production system 100.

[0052] The first direction is Figure 3 The X direction shown is the height direction of the drug production system 100, and the second direction is... Figure 3 The Y direction is shown. As an embodiment of this application, the first drive module 13 may include a motor, a lead screw module, and a gripper 17. The motor can serve as a power source to drive the lead screw module and the gripper 17 to work, providing power for driving the second reaction container 50 to reciprocate along the first direction. The lead screw module realizes the displacement of the gripper 17, meeting the high-precision requirements for the position of the second reaction container 50. The gripper 17 is used to realize the grasping, moving, and placing of the second reaction container 50, which is simple and quick, reducing the difficulty of operation and time cost.

[0053] The first drive module 13 can then drive the second reaction container 50 to reciprocate along the first direction, thereby thoroughly mixing the drug in that direction. The first and second reactants within the second reaction container 50 undergo continuous agitation in the first direction, facilitating mixing. This automated mixing process is more efficient than manual operation, enabling the mixing of large quantities of drug in a short time, thus improving production efficiency. Furthermore, the uniformly mixed drug exhibits more stable efficacy during subsequent packaging and use, contributing to improved final product quality. It should be noted that the first direction can be any direction of the drug production system 100, such as the height or lateral direction, as long as it allows for thorough mixing of the drug.

[0054] The design of the first drive module 13 allows the second reaction container 50 to be adjusted according to different drug properties and mixing requirements, making it suitable for mixing multiple drugs. The first drive module 13 may also include structures such as a motor, slide rail, and clamping mechanism, as long as the first drive module 13 is configured to drive the second reaction container 50 to reciprocate along the first direction.

[0055] like Figure 3 As shown, the first direction is the height direction of the drug production system 100. This allows the drug to undergo more thorough vertical movement and mixing during synthesis, helping to break up drug aggregation and ensuring more uniform dispersion of drug components in the solvent or carrier. A uniformly mixed drug exhibits more stable efficacy during subsequent packaging and use, thereby improving drug quality and therapeutic effect. Furthermore, setting the first direction as the height direction helps optimize the spatial layout of the drug production system 100. By rationally designing the structure of the drug production system 100, the internal space resources can be fully utilized, reducing the equipment's footprint and volume.

[0056] According to some embodiments of the present invention, such as Figure 3 As shown, the second reaction container 50 and the needle assembly 20 are arranged opposite each other along a first direction. The second reaction container 50 is driven to move along the first direction by the first drive module 13 so that the needle assembly 20 can be accurately inserted into the second reaction container 50. The linear motion path eliminates the accumulated error in multi-axis linkage, so that the needle assembly 20 can be accurately inserted into the designated position (such as the sealing membrane or liquid inlet) of the second reaction container 50, reducing the risk of collision between the needle assembly 20 and the surrounding structure of the second reaction container 50, and improving equipment safety. Furthermore, the relative arrangement minimizes the movement path of the second reaction container 50, reduces unnecessary displacement time, and reduces the time for drug synthesis and dispensing.

[0057] According to some embodiments of the present invention, such as Figure 7A and Figure 7BAs shown, the drug synthesis apparatus 10 also includes a heating device 24, which is used to heat the second reaction vessel 50.

[0058] The heating device 24 can be configured as an electric heating mantle, an electric furnace, an electric heating plate, an electric steam generator, etc., without specific limitations. The heating device 24 can be used to heat the second reaction vessel 50, and can heat the mixture of the first reactant and the second reactant inside the second reaction vessel 50, providing strong support for the heat treatment of the synthesized drug, fulfilling the requirements of the drug synthesis process, and ensuring the quality and efficacy of the drug.

[0059] According to some embodiments of the present invention, such as Figure 3 As shown, the drug production system 100 also includes a support 40, which has a placement space 41 with an open end for placing a second reaction container 50. When the second reaction container 50 is placed in the placement space 41, the neck and mouth of the second reaction container 50 are exposed from the open end of the placement space 41.

[0060] The support base 40 has a placement space 41 with an open end. The placement space 41 matches the shape of the second reaction container 50 so that it can be used to place the second reaction container 50. The open end serves as the inlet for loading and unloading the second reaction container 50. The second reaction container 50 can be fixed by setting limiting or elastic buckles on the side wall of the placement space 41 to restrict its horizontal movement and prevent it from tipping over due to equipment vibration or operational impact, thus ensuring reaction safety. Furthermore, the open end allows the first drive module 13 to directly grasp and drive the second reaction container 50 to move along the first direction, shortening the drug synthesis time. It can be noted that, along the first direction, the support base 40 can be located below the needle assembly 20 to facilitate the rapid movement of the second reaction container 50 to the needle assembly 20 for insertion and engagement.

[0061] like Figure 3 As shown, the placement space 41 has an open end. When the second reaction container 50 is placed in the placement space 41, the neck and mouth of the second reaction container 50 are exposed from the open end of the placement space 41.

[0062] The open end design eliminates the need for additional steps like opening the hatch or flipping the lid when moving the second reaction container 50. With the second reaction container 50 placed within the placement space 41, its neck and mouth are exposed from the open end, facilitating the first drive module 13's smooth grasping of the second reaction container 50. The open end also provides an unobstructed grasping path for the first drive module 13, enabling automatic transfer of the second reaction container 50 and enhancing the automation level of the drug production system 100. The exposed neck and mouth of the second reaction container 50 also facilitate the insertion and mating of the needle assembly 20 with the second reaction container 50, reducing operational errors caused by tilting or obstruction of the second reaction container 50.

[0063] According to some embodiments of the present invention, such as Figure 7A and Figure 7B As shown, the drug synthesis apparatus 10 further includes: a heating device 24, which is disposed within the support base 40 and is used to heat the second reaction vessel 50; and / or the support base 40, the second reaction vessel 50, and the needle assembly 20 are arranged along a first direction, with the second reaction vessel 50 located between the support base 40 and the needle assembly 20, the first direction being the height direction of the drug production system 100.

[0064] The heating device 24 can be housed within the placement space 41 of the support base 40, allowing it to directly contact the second reaction vessel 50. Heating the second reaction vessel 50 via the heating device 24 reduces air gaps in the heat transfer path, helping to minimize heat loss, improve heating efficiency, and reduce the procurement, assembly, and debugging of independent heating components, thus lowering costs. Furthermore, the heating device 24 and the support base 40 can be integrated seamlessly, resulting in a compact structure that eliminates the need for additional heating plates or hot air modules. The open placement space 41 also maintains the ease of loading and unloading the second reaction vessel 50.

[0065] like Figure 3 As shown, the support base 40, the second reaction container 50 and the needle assembly 20 are arranged along the first direction, and the second reaction container 50 is located between the support base 40 and the needle assembly 20. The first direction is the height direction of the drug production system 100.

[0066] The support base 40 is used for placing and fixing the second reaction container 50, and the pin assembly 20 is located above the second reaction container 50. In this embodiment, the support base 40 and the pin assembly 20 are fixedly arranged. Specifically, the support base 40 is fixedly arranged on the base (not shown), and the pin assembly 20 is fixedly arranged on the mounting mechanism (not shown). The second reaction container 50 can move between the support base 40 and the pin assembly 20 by the drive of the first drive module 13, so that the second reaction container 50 can move and be placed in the placement space 41 of the support base 40, and also so that the second reaction container 50 can move to the pin assembly 20 for insertion and engagement. The support base 40, the second reaction container 50, and the needle assembly 20 are arranged along the first direction, with the second reaction container 50 located between the support base 40 and the needle assembly 20. This conforms to the reasonable movement of the second reaction container 50, avoids multi-directional movement of the second reaction container 50, and makes the support base 40, the second reaction container 50, and the needle assembly 20 more compact. This helps to optimize the spatial layout of the drug production system 100, make full use of the internal space resources of the drug production system 100, and reduce the floor area and volume of the equipment.

[0067] According to some embodiments of the present invention, such as Figure 7B and Figure 7C As shown, the drug synthesis apparatus 10 also includes a heat dissipation device 25, which is used to cool the second reaction vessel 50. The drug production system 100 also includes: a first drive module 13, which can drive the second reaction vessel 50 to move, and a heat dissipation device 25 fixed to the first drive module 13.

[0068] The heat dissipation device 25 can be constructed as a fan, heat sink, liquid cooling device 25, etc., and is not specifically limited here, as long as the heat dissipation device 25 can be used to cool the second reaction vessel 50. The heat dissipation device 25 acts directly on the second reaction vessel 50, and can effectively remove the heat from the second reaction vessel 50 and the mixed reactants inside, thereby achieving a cooling effect.

[0069] like Figure 7B and Figure 7CAs shown, the first drive module 13 can drive the second reaction container 50 to move. The heat dissipation device 25 can be fixedly mounted on the first drive module 13. In some embodiments of this application, the heat dissipation device 25 and the first drive module 13 can be fixedly connected by welding or by snap-fit. However, the present invention is not limited to this. The heat dissipation device 25 and the first drive module 13 can also be fixedly connected by other means, as long as the heat dissipation device 25 is located on the first drive module 13. The heat dissipation device 25 can be correspondingly arranged with the second reaction container 50 so that the heat dissipation device 25 can smoothly cool down the second reaction container 50. When the first drive module 13 drives the second reaction container 50 to move, the heat dissipation device 25 can simultaneously and smoothly cool down the second reaction container 50, providing strong support for the cooling treatment of the drug and ensuring the quality and efficacy of the drug.

[0070] According to some embodiments of the present invention, such as Figure 7B and Figure 7C As shown, along the first direction, at least a portion of the heat dissipation device 25 and the second reaction vessel 50 are located on the same side of the first drive module 13, and the first direction is the height direction of the drug production system 100.

[0071] Along the first direction, at least a portion of the heat dissipation device 25 and the second reaction container 50 are located on the same side of the first drive module 13. Both the heat dissipation device 25 and the second reaction container 50 may have one-half or two-thirds of their portions located on the same side of the first drive module 13. However, the present invention is not limited to this. The heat dissipation device 25 and the second reaction container 50 may also have other proportions of their portions located on the same side of the first drive module 13, as long as at least a portion of the heat dissipation device 25 and the second reaction container 50 are located on the same side of the first drive module 13.

[0072] As an example of the present invention, along the first direction, the heat dissipation device 25 and the second reaction container 50 are both located on the lower side of the first drive module 13, specifically the gripper 17, and the heat dissipation device 25 can extend downward along the first direction so that the heat dissipation device 25 is correspondingly arranged with the second reaction container 50, thereby enabling the heat dissipation device 25 to fully cool the second reaction container 50, providing strong support for the cooling treatment of the drug, and ensuring the quality and efficacy of the drug.

[0073] According to some embodiments of the present invention, such as Figure 7B and Figure 7C As shown, the heat dissipation device 25 has a blower 251, through which the heat dissipation device 25 blows air to the second reaction vessel 50.

[0074] The heat dissipation device 25 has an air outlet 251 that can extend downward in the first direction, so that the shape of the air outlet 251 corresponds to the shape of the second reaction container 50. The heat dissipation device 25 blows air to the second reaction container 50 through the air outlet 251, which can fully cool the second reaction container 50, improve the cooling efficiency of the heat dissipation device 25 on the second reaction container 50, provide strong support for the cooling treatment of the drug, and ensure the quality and efficacy of the drug.

[0075] According to some embodiments of the present invention, the air outlet 251 extends along the depth direction of the second reaction container 50, so that the shape of the air outlet 251 corresponds to the shape of the second reaction container 50. The heat dissipation device 25 blows air to the second reaction container 50 through the air outlet 251, which can fully cool the second reaction container 50, improve the cooling efficiency of the heat dissipation device 25 on the second reaction container 50, and further provide strong support for the cooling treatment of the drug, ensuring the quality and efficacy of the drug.

[0076] According to some embodiments of the present invention, such as Figure 3 As shown, the drug synthesis apparatus 10 also includes a first shielding and radiation protection structure 23, which can surround the second reaction container 50, and the first shielding and radiation protection structure 23 is constructed in an arc shape.

[0077] The first radiation shielding structure 23 can be made of shielding materials such as iron, copper, tungsten, and lead. It surrounds the second reaction container 50, providing enhanced shielding when the container contains radioactive reactants, effectively shielding it from radiation generated by the radioactive material or agent, thus protecting the surrounding environment and personnel. Furthermore, by specifically protecting the second reaction container 50 with the first radiation shielding structure 23, the overall protective material requirements for the external components of the drug production system 100 can be reduced. In this application scenario, this is specifically manifested in the isolation cabinet 200, thereby reducing the overall weight of the drug production system 100 and the external isolation cabinet 200, and consequently reducing the load-bearing capacity of the floor where they are located.

[0078] like Figure 3 As shown, the first shielding radiation protection structure 23 can be constructed as an arc-shaped structure. The first shielding radiation protection structure 23 better surrounds the second reaction container 50, and the arc-shaped structure can distribute the shielding material more evenly, thereby more effectively blocking and absorbing the radiation of the radioactive reactants in the second reaction container 50, and providing more comprehensive protection for medical personnel.

[0079] Furthermore, as a specific embodiment of the present invention, the first shielding radiation protection structure 23 can be constructed as a "U"-shaped arc structure so that the first shielding radiation protection structure 23 can surround the pin assembly 20, the second reactor, and the support base 40 in different positions, thereby enhancing the shielding around the operator's activities. Since the operator generally operates on the front and left / right sides of the equipment, the first shielding radiation protection structure 23 with its "U"-shaped arc structure has sufficient shielding effect. There is no need to set the first shielding radiation protection structure 23 as a "U" shape, which reduces the weight of the first shielding radiation protection structure 23 and makes the equipment lightweight. If the equipment is installed in a corner, the first shielding radiation protection structure 23 can also be designed as an "L" shape or a "I" shape. The shape of the first shielding radiation protection structure 23 can be reasonably designed according to the actual situation, as long as it can meet the requirement of shielding around the operator's activities.

[0080] According to some embodiments of the present invention, such as Figure 3 As shown, the first shielding radiation protection structure 23 includes at least one shielding part 231, which is closer to the operator relative to the second reaction container 50.

[0081] The first radiation shielding structure 23 may include one, two, or three shielding portions 231, but the invention is not limited to this; the first radiation shielding structure 23 may also include other numbers of shielding portions 231, as long as the first radiation shielding structure 23 includes at least one shielding portion 231. The shielding portion 231 is closer to the operator than the second reaction container 50, effectively isolating the second reaction container 50 from the operator. When the reactant in the second reaction container 50 is radioactive, isolating the second reaction container 50 from the operator through the shielding portion 231 directly reduces the radiation flux reaching the operator, significantly reducing the radioactive hazard to the operator from the radiopharmaceutical.

[0082] According to some embodiments of the present invention, such as Figure 3 As shown, the drug synthesis apparatus 10 further includes a second drive module 14, which is connected to the first shielding and radiation protection structure 23. The second drive module 14 is used to drive the first shielding and radiation protection structure 23 to move so that the first shielding and radiation protection structure 23 remains around the second reaction container 50.

[0083] The second drive module 14 may include a lead screw module, a slide rail, and other mechanisms. The second drive module 14 and the first shielding and radiation-proof structure 23 can be slidably or threadedly connected, allowing the second drive module 14 to drive the movement of the first shielding and radiation-proof structure 23. This ensures the first shielding and radiation-proof structure 23 remains surrounding the second reaction container 50. When the second reaction container 50 contains radioactive reactants, the second drive module 14 drives the first shielding and radiation-proof structure 23 to move along with the second reaction container 50, thus ensuring the first shielding and radiation-proof structure 23 always surrounds the second reaction container 50, effectively shielding it and blocking and absorbing radiation from the radioactive reactants within the second reaction container 50, providing more comprehensive protection for medical personnel. When the reactants in the second reaction container 50 are not radioactive, the first shielding and radiation-proof structure 23 can remain in place or be removed. This configuration enhances the flexibility of the first radiation shielding structure 23, making the drug production system 100 suitable for the synthesis and packaging of different types of drugs, thus further improving the applicability of the drug production system 100.

[0084] According to some embodiments of the present invention, the second drive module 14 can drive the first shielding radiation protection structure 23 to move in the same direction as the second reaction container 50. When the second reaction container 50 is displaced due to demand, the second drive module 14 can drive the first shielding radiation protection structure 23 to move at the same speed and direction, ensuring that the first shielding radiation protection structure 23 always covers the second reaction container 50, avoiding protective gaps caused by the movement of the second reaction container 50, thereby reducing the radioactive hazards of radiopharmaceuticals to operators.

[0085] According to some embodiments of the present invention, the second drive module 14 can drive the first shielding radiation protection structure 23 to move synchronously with the second reaction container 50, which can further ensure that the first shielding radiation protection structure 23 always covers the second reaction container 50, eliminate the protective gap caused by the movement of the second reaction container 50, and thus further reduce the radioactive hazards of radiopharmaceuticals to operators.

[0086] According to some embodiments of the present invention, such as Figure 3 and Figure 6 As shown, the first conveying component 11 includes a first pipeline 111, and the first driving mechanism 12 includes a first peristaltic pump 121. The first pipeline 111 connects the first reaction container 16 and the second reaction container 50. At least a portion of the first pipeline 111 is installed in the first extrusion groove 214 of the first peristaltic pump 121.

[0087] The first conduit 111 is used to connect the first reaction container 16 and the second reaction container 50, thereby enabling the delivery of the first reactant. At least a portion of the first conduit 111 is installed in the first extrusion groove 214 of the first peristaltic pump 121, so that the first peristaltic pump 121 delivers the first reactant by extruding the first conduit 111. The delivery amount of the first reactant can be precisely controlled by adjusting the rotation speed of the first peristaltic pump 121, so that the first reactant can be delivered from the first reaction container 16 to the second reaction container 50 at a predetermined flow rate and speed, ensuring the quantitative delivery of the drug.

[0088] The working principle of the first peristaltic pump 121 determines the continuity and stability of its delivery process. Since the first pipeline 111 is fixed in the first extrusion groove 214, the extrusion action of the pump head roller on the first pipeline 111 is uniform and stable, thereby avoiding fluctuations and instability of the first reactant during delivery. It also avoids delivering the first reactant through the syringe each time, reducing the consumables of the syringe, and also avoids the first reactant remaining in the syringe and contaminating the subsequently synthesized drug. By pushing the liquid in the first pipeline 111 forward by the first peristaltic pump 121, it will not touch the liquid in the first pipeline 111, avoiding contamination and residue, thereby improving the stability and reliability of drug synthesis in the drug production system 100.

[0089] According to some embodiments of the present invention, such as Figure 3 As shown, the first reaction vessel 16 includes a nuclide generator 215 and a reagent preparation device. The nuclide generator 215 has a generator inlet 212 and a generator outlet 213. The generator inlet 212 is connected to the reagent preparation device. The first pipeline 111 is connected to the generator outlet 213 and the second reaction vessel 50.

[0090] The nuclide generator 215 has a generator inlet 212 and a generator outlet 213. The generator inlet 212 is used to connect with the preparation reagent (e.g., 5 ml of hydrochloric acid), and the preparation reagent can be delivered to the nuclide generator 215 through the generator inlet 212 to achieve rinsing of the nuclide generator 215. The first pipeline 111 is used to connect the generator outlet 213 and the second reaction vessel 50, and the first reactant (e.g., radioactive isotope) that has been rinsed off can be delivered to the second reaction vessel 50 through the generator outlet 213 and the first pipeline 111.

[0091] According to some embodiments of the present invention, the nuclide generator 215 is located near the shielding door of the isolation cabinet 200, so that the operator can easily open the shielding door to take out and replace the nuclide generator.

[0092] According to some embodiments of the present invention, such as Figure 3As shown, in the flow direction of the first reactant within the first conveyor 11, the first peristaltic pump 121 is located downstream of the nuclide generator 215 and upstream of the second reaction vessel 50.

[0093] In the flow direction of the first reactant within the first conveying member 11, the first peristaltic pump 121 is located downstream of the nuclide generator 215 and upstream of the second reaction vessel 50, conforming to the flow path of the first reactant. This allows the first peristaltic pump 121 to smoothly transport the first reactant (e.g., a radioactive isotope) rinsed down from the nuclide generator 215 through the generator outlet 213 and the first pipeline 111 to the second reaction vessel 50, and enables continuous transport of the first reactant.

[0094] Furthermore, as a specific embodiment of this application, the drug production system 100 of this application may include one or more of the following steps in the drug synthesis steps. The order of the steps may be changed as needed. The steps are only listed here and the specific order of the steps is not limited: The first drive module 13 moves the second reaction container 50 relative to the pin assembly 20 so that the pin assembly 20 is inserted into the second reaction container 50 (e.g., the gripper 17 drives the second reaction container 50 to move toward the pin assembly 20 so that the pin assembly 20 is inserted into the second reaction container 50). The first peristaltic pump 121 drives the preparation reagent (e.g., 5 ml of hydrochloric acid) to flow through the nuclide generator 215 and into the second reaction vessel 50, realizing the rinsing function of the nuclide generator 215. The rinsed first reactant (e.g., radioactive isotope) flows into the second reaction vessel 50 through the first pipeline 111 and mixes with the second reactant in the second reaction vessel 50 to form the preparation solvent. The gas in the second reaction vessel 50 is discharged by the needle assembly 20 (e.g., the first needle 21) to balance the gas pressure inside and outside the second reaction vessel 50. During the rinsing process, the needle assembly 20 is separated from the preparation solvent in the second reaction vessel 50. The second reaction vessel 50 is moved away from the pin assembly 20 by the first drive module 13 (e.g., gripper 17); The second reaction container 50 is driven to reciprocate along the first direction by the first drive module 13 (e.g., gripper 17) to mix the drug in the second reaction container 50. The second reaction container 50 is moved toward the support base 40 by the first drive module 13 (e.g., gripper 17) so that the second reaction container 50 is moved into the placement space 41 of the support base 40.

[0095] According to some embodiments of the present invention, after the second reaction vessel 50 is moved into the placement space 41, at least one or more of the following steps may be included. The order of the steps may be changed as needed. The steps are only listed here and the specific order of the steps is not limited: The mixed reactants in the second reaction vessel 50 are placed in the placement space 41 of the support 40 and left to stand for a period of time to wait for drug synthesis.

[0096] According to some embodiments of the present invention, after the second reaction vessel 50 is moved into the placement space 41, at least one or more of the following steps may be included. The order of the steps may be changed as needed. The steps are only listed here and the specific order of the steps is not limited: The heating device 24 inside the support 40 heats the second reaction vessel 50, accelerating the synthesis; The second reaction vessel 50 is cooled by the heat dissipation device 25.

[0097] According to some embodiments of the present invention, the following steps are included before cooling the second reaction vessel 50 by the heat dissipation device 25: The second reaction vessel 50 is moved away from the support base 40 by the first drive module 13 (e.g., gripper 17) so that the second reaction vessel 50 is removed from the placement space 41 of the support base 40. This process ensures that the heat dissipation device 25 cools only the second reaction vessel 50 and does not cool the heating device, thus improving heating efficiency.

[0098] According to some embodiments of the present invention, before the drug synthesis step begins, one or more of the following steps may be included. The order of these steps may be changed as needed. This is merely a list of steps and does not limit the specific order of the steps: Perform a 100% self-inspection on the drug production system to check whether all functions of the system can be used normally and eliminate potential faults in advance; Add the required amount of drug powder into the second reaction container 50, and inject 1 ml of water for injection into the second reaction container 50. After thoroughly shaking and dissolving the powder, install the second reaction container 50 onto the support base 40. Connect the reagent (e.g., 5 ml of hydrochloric acid) to the generator inlet 212 of the radionuclide generator 215; One end of the first pipe 111 is connected to the generator outlet 213 of the nuclide generator 215, and at least a portion of the first pipe 111 is installed in the first extrusion groove 214 of the first peristaltic pump 121. The other end of the first pipe 111 is connected to the second reaction vessel 50. The pin assembly 20 is then installed in place. By pre-connecting and installing all pipes and assemblies, subsequent operations are completed by each module, reducing human intervention, achieving a high degree of automation, and avoiding radiation-induced harm to the human body.

[0099] According to some embodiments of the present invention, the following steps may be included before the step of completing the installation of the first conduit or before the start of the drug synthesis step and after the installation of the first conduit 111: If necessary, the heating device 24 is activated for preheating. This preheating process saves time in reaching the predetermined temperature and improves drug production efficiency.

[0100] like Figures 1-9 As shown, a drug production system 100 according to an embodiment of the present invention includes: A first reaction container 16 and a second reaction container 50, wherein the first reaction container 16 is used to store the first reactant and the second reaction container 50 is used to store the second reactant; The first conveyor 11 is connected to the first reaction vessel 16 and the second reaction vessel 50; The drug synthesis apparatus 10 includes a first drive mechanism 12, which cooperates with a first conveyor 11 to drive a first reactant to flow along the first conveyor 11 into a second reaction vessel 50 for synthesis. Dispensing container 34 is used to store the synthesized drug; The second conveyor 31 is used to convey the synthesized drug; The drug dispensing device 30 includes a second drive mechanism 32, which cooperates with a second conveyor 31 to drive the synthesized drug to flow into the dispensing container 34 along the second conveyor 31. The pin assembly 20 and the second conveyor 31 connect the pin assembly 20 and the dispensing container 34. The pin assembly 20 is adapted to be inserted into or removed from the second reaction container 50. When the pin assembly 20 is inserted into the second reaction container 50, the pin assembly 20 has a first position and a second position relative to the second reaction container 50. When the pin assembly 20 is in the first position, the first reactant in the first reaction container 16 flows into the second reaction container 50, and the gas in the second reaction container 50 is discharged through the pin assembly 20. When the needle assembly 20 is in the second position, the synthesized drug flows into the dispensing container 34 through the needle assembly 20, and the gas outside the second reaction container 50 flows into the second reaction container 50 through the needle assembly 20.

[0101] In one example of the present invention, both the first reaction container 16 and the second reaction container 50 can be vials. The first reaction container 16 is used to store the first reactant, and the second reaction container 50 is used to store the second reactant. The first conveying member 11 can be a first pipeline 111, which connects the first reaction container 16 and the second reaction container 50 to convey the first reactant in the first reaction container 16 to the second reaction container 50.

[0102] The drug synthesis apparatus 10 is used to synthesize drugs. The apparatus includes a first driving mechanism 12, which can be a first peristaltic pump 121. The first driving mechanism 12 and a first conveying member 11 cooperate to drive a first reactant along the first conveying member 11 into a second reaction container 50 for synthesis, thereby enabling drug synthesis. As an example of the present invention, the first reactant in the first reaction container 16 can be hydrochloric acid reagent, and the second reactant in the second reaction container 50 can be a drug injection solution. However, the present invention is not limited to this; both the first and second reactants can be reasonably selected according to actual conditions.

[0103] The dispensing container 34 can be a syringe, dispensing bottle, or other container, for storing the dispensed drug. The second conveying member 31 can be a second pipeline 313, used to convey the drug for dispensing, and can also deliver the synthesized drug into the dispensing container 34 for storage. The drug dispensing device 30 is used to dispense the synthesized drug. The drug dispensing device 30 includes a second driving mechanism 32, which can be a second peristaltic pump 322. The second driving mechanism 32 and the second conveying member 31 cooperate to drive the synthesized drug along the second conveying member 31 into the dispensing container 34, thereby realizing the automatic dispensing of the synthesized drug.

[0104] The second conveying member 31 connects the pin assembly 20 and the dispensing container 34. The pin assembly 20 is adapted to be inserted into or removed from the second reaction container 50. When the pin assembly 20 is inserted into the second reaction container 50, the pin assembly 20 has a first position and a second position relative to the second reaction container 50. When the pin assembly 20 is in the first position, the first reaction material in the first reaction container 16 flows into the second reaction container 50, and the gas in the second reaction container 50 is discharged through the pin assembly 20 to balance the gas pressure inside and outside the second reaction container 50 and reduce the risk of the second reaction container 50 rupture or reduced sealing.

[0105] Specifically, an imbalance in the internal and external pressures of the second reaction container 50 may cause the first drive mechanism 12 to idle and malfunction. Furthermore, an imbalance in the internal and external pressures of the second reaction container 50 may lead to rupture or a decrease in its sealing performance. If the reactant solution inside the second reaction container 50 is a radioactive liquid, it could expose workers to radiation, affecting their health. Additionally, if the synthesized drug needs to be dispensed later, excessively high pressure inside the second reaction container 50 could cause the solution inside to gush out and contaminate the surrounding environment the moment the needle assembly 20 is inserted into it. Therefore, by using the needle assembly 20 in the first position, the first reactant flow from the first reaction container 16 into the second reaction container 50, and the gas inside the second reaction container 50 is discharged through the needle assembly 20, thus balancing the internal and external pressures of the second reaction container 50. This reduces the risk of rupture or decreased sealing performance of the second reaction container 50, and improves the safety and reliability of the drug production system 100.

[0106] When the needle assembly 20 is in the second position, the synthesized drug flows into the dispensing container 34 through the needle assembly 20, and the gas outside the second reaction container 50 flows into the second reaction container 50 through the needle assembly 20 to further balance the gas pressure inside and outside the second reaction container 50. This allows the synthesized drug in the second reaction container 50 to be completely sucked out, avoiding residue and waste, and improving the safety and reliability of the drug production system 100.

[0107] The needle assembly 20 enables the gas pressure inside the second reaction container 50 to be balanced, allowing the second reactant inside the second reaction container 50 to smoothly enter and exit the second reaction container 50. Furthermore, the same needle assembly 20 can perform multiple functions at different positions without the need to introduce other venting needles, simplifying the operation steps of drug synthesis and dispensing, and reducing the cost of drug synthesis and dispensing.

[0108] Therefore, the drug production system 100 enables automated synthesis and packaging of drugs, especially in applications involving the synthesis and packaging of radiopharmaceuticals. This reduces contact between medical personnel and drugs, significantly lowering the risk of radioactive hazard to healthcare workers. Furthermore, the automated synthesis and packaging allows for pre-setting of reactant parameters, accurately controlling the delivery rate, mixing ratio, and packaging volume of reactants. This ensures the stability and consistency of the synthesized drug quality, avoids human error, and improves the precision and efficiency of drug synthesis and packaging. Additionally, by injecting different drugs into the drug production system 100, and through the coordinated use of the drug synthesis device 10 and the drug packaging device 30, the synthesis and packaging of different drugs can be achieved. This enhances the versatility and applicability of the drug production system 100, enabling it to meet the synthesis and packaging needs of various types and specifications of drugs.

[0109] The drug synthesis device 10 in the drug production system 100 of this embodiment is the same as the drug synthesis device 10 described previously, and will not be repeated here. The following will focus on describing the drug dispensing device 30 and its related process flow.

[0110] According to some embodiments of the present invention, such as Figure 3 As shown, the drug dispensing device 30 also includes a multi-port member 311, a second conveying member 31 connecting the needle assembly 20 and the multi-port member 311, the second conveying member 31 connecting the dispensing container 34 through the multi-port member 311, and the multi-port member 311 being movable to connect or separate the multi-port member 311 from the dispensing container 34.

[0111] The multi-port component 311 typically has at least two connection ports. In this embodiment, the multi-port component 311 has two connection ports, which are respectively connected to the second conveyor component 31 and the dispensing container 34. The second conveyor component 31 connects to the needle assembly 20 and the multi-port component 311. The second conveyor component 31 can be connected to the second reaction container 50 through the needle assembly 20, thereby realizing the delivery and dispensing of the synthesized drug in the second reaction container 50. The multi-port component 311 is movable to connect or disconnect from the dispensing container 34, which meets the working requirements of this device. When venting is required, the multi-port component 311 is disconnected from the dispensing container 34. When dispensing the synthesized drug is required, the multi-port component 311 can be connected to the dispensing container 34 so that the synthesized drug is delivered to the dispensing container 34 for storage by the needle assembly 20, the second conveyor component 31, and the multi-port component 311. Furthermore, by precisely controlling the insertion and withdrawal of the needle assembly 20 from the second reaction container 50, the timing of drug delivery after synthesis can be precisely controlled, thereby ensuring that the drug can successfully reach the target location. Thus, through the cooperation of the second delivery component 31, the multi-channel component 311, the needle assembly 20, and the dispensing container 34, automatic drug dispensing can be achieved, reducing drug waste and losses during delivery, and improving the efficiency and safety of drug dispensing.

[0112] According to some embodiments of the present invention, when the first reactant flows from the first reaction container 16 into the second reaction container 50, the multi-port 311 is separated from the dispensing container 34; when the synthesized drug flows into the dispensing container 34, the multi-port 311 is connected to the dispensing container 34.

[0113] When the first reactant flows from the first reaction container 16 into the second reaction container 50, the multi-port 311 separates from the dispensing container 34 so that the gas in the second reaction container 50 is discharged through the pin assembly 20, the second conveying component 31, and the multi-port 311, thereby balancing the gas pressure inside and outside the second reaction container 50 and reducing the risk of the second reaction container 50 rupturing or losing its seal.

[0114] When the synthesized drug flows into the dispensing container 34, the multi-port component 311 is connected to the dispensing container 34 to ensure that the synthesized drug flows smoothly into the dispensing container 34, thereby realizing automatic drug dispensing.

[0115] According to some embodiments of the present invention, such as Figure 3 As shown, the drug dispensing device 30 also includes a third drive module 15, which is connected to the multi-port component 311. The third drive module 15 is used to drive the multi-port component 311 to move so that the multi-port component 311 can be connected to or separated from the dispensing container 34.

[0116] The third drive module 15 may include a lead screw module, a slide rail, and other mechanisms. The third drive module 15 and the multi-channel component 311 can be connected by sliding or threading. The third drive module 15 is used to drive the multi-channel component 311 to move so that the multi-channel component 311 can be connected to or separated from the dispensing container 34. It can realize the venting of the second reaction container 50 when the multi-channel component 311 is separated from the dispensing container 34, and can realize the dispensing of drugs when the multi-channel component 311 is connected to the dispensing container 34. This improves the automation level of the drug production system 100, reduces the contact between medical personnel and drugs, and greatly reduces the radiation hazards of radioactive drugs to medical personnel.

[0117] Furthermore, the first drive module 13 and the second drive module 14 can be arranged along the second direction, and the third drive module 15 and the first drive module 13 can be arranged along the third direction, which is (for...) Figure 3 The Z-direction, the first direction, and the second direction are perpendicular to each other.

[0118] like Figure 3 As shown, the first drive module 13, the second drive module 14, the third drive module 15, and the first shielding and radiation protection structure 23 are distributed around the gripper 17, the second reaction container 50, the support base 40, and the pin assembly 20. This arrangement is beneficial to the structural compactness of the drug production system 100, and if the drug production system 100 is subjected to external impact, each drive module and the shielding and radiation protection structure can protect the core components (such as the gripper 17, the second reaction container 50, the support base 40, and the pin assembly 20) from damage.

[0119] The grippers 17 of the second drive module 14 and the first drive module 13 can be configured to move synchronously. When the first drive module 13 drives the second reaction container 50 to move, the second drive module 14 can drive the first shielding radiation protection structure 23 to move synchronously with the second reaction container 50. This can further ensure that the first shielding radiation protection structure 23 always covers the second reaction container 50, eliminating the protective gap caused by the movement of the second reaction container 50. This can further reduce the radioactive hazards of radiopharmaceuticals to operators. In addition, when subjected to external impact, the first shielding radiation protection structure can protect the second reaction container from rupture, which could lead to radioactive contamination of the entire drug production system.

[0120] The third drive module 15 and the dispensing container 34 in the second shielding and radiation protection structure 33 can be adjacent to each other, so that the third drive module 15 can drive the multi-channel component 311 to move relative to the dispensing container 34 to connect or disconnect the multi-channel component 311 and the dispensing container 34.

[0121] from Figure 3 As can be seen, the first drive mechanism 12 and the second drive mechanism 32 are independently and separately arranged from the first drive module 13, the second drive module 14, and the third drive module 15, which is beneficial for the maintenance and replacement of drive mechanisms 12 and 32; and in the front-rear direction (i.e. Figure 3 In the Z direction (as shown in the diagram), relative to drive modules 13, 14, and 15, the first drive mechanism 12 and the second drive mechanism 32 are positioned closer to the support base 40. Figure 3 As can be seen, the drive mechanisms 12 and 32 are located in front of the support base 40, which is beneficial to the arrangement of the conveying components 11 and 31 and will not cause the conveying components 11 and 31 to become intertwined and tangled.

[0122] from Figure 3 As can be seen from this, in the left and right direction (i.e. Figure 3 In the Y direction, the first drive mechanism 12 is arranged closer to the first reaction vessel 16 than the second drive mechanism 32.

[0123] According to some embodiments of the present invention, such as Figure 3 As shown, the drug dispensing device 30 also includes: a mounting base 312, which is fixed to the third drive module 15, and a multi-channel component 311 which is fixed to the mounting base 312. The third drive module 15 drives the mounting base 312 to move the multi-channel component 311.

[0124] The mounting base 312 is fixed to the third drive module 15. In some embodiments of the present invention, the mounting base 312 and the third drive module 15 can be fixedly connected by welding, or the mounting base 312 and the third drive module 15 can be integrally formed. However, the present invention is not limited to this. The mounting base 312 and the third drive module 15 can also be fixedly connected by other means, as long as the mounting base 312 is fixed to the third drive module 15.

[0125] The multi-port component 311 is fixed to the mounting base 312. In some embodiments of the present invention, the multi-port component 311 and the mounting base 312 can be fixedly connected by snap-fit ​​or by adhesive bonding. However, the present invention is not limited to this. The multi-port component 311 and the mounting base 312 can also be fixedly connected by other means, as long as the multi-port component 311 is fixed to the mounting base 312.

[0126] The third drive module 15 drives the mounting base 312 to move the multi-channel component 311. When the third drive module 15 moves, the mounting base 312 and the third drive module 15 move synchronously to drive the multi-channel component 311 to move synchronously, so as to realize the connection or separation of the multi-channel component 311 from the dispensing container 34. Thus, when the multi-channel component 311 is separated from the dispensing container 34, the second reaction container 50 can be vented, and when the multi-channel component 311 is connected to the dispensing container 34, the drug can be dispensed. This improves the automation level of the drug production system 100, reduces the contact between medical personnel and drugs, and greatly reduces the radiation hazards of radiopharmaceuticals to medical personnel.

[0127] According to some embodiments of the present invention, such as Figure 3 and Figure 6 As shown, the second conveying component 31 includes a second conduit 313, and the second drive mechanism 32 includes a second peristaltic pump 322. The second conduit 313 connects the pin assembly 20 and the dispensing container 34, and at least a portion of the second conduit 313 is installed in the second extrusion groove 321 of the second peristaltic pump 322.

[0128] The second conduit 313 connects the needle assembly 20 and the dispensing container 34. The needle assembly 20 is connected to the second reaction container 50, enabling the delivery of the synthesized drug within the second reaction container 50. At least a portion of the second conduit 313 is installed within the second extrusion groove 321 of the second peristaltic pump 322, allowing the second peristaltic pump 322 to deliver the synthesized drug by extruding the second conduit 313. The delivery rate of the synthesized drug can be precisely controlled by adjusting the rotational speed of the second peristaltic pump 322, ensuring that the synthesized drug is delivered from the second reaction container 50 to the dispensing container 34 at a predetermined flow rate and speed, thus guaranteeing the quantitative delivery and dispensing of the synthesized drug. The working principle of the second peristaltic pump 322 determines the continuity and stability of its delivery process. Since the second conduit 313 is fixed within the second extrusion groove 321, the extrusion action of the pump head roller on the second conduit 313 is uniform and stable, thereby avoiding fluctuations and instability in the delivery process of the synthesized drug, and thus improving the stability and reliability of drug synthesis in the drug production system 100.

[0129] Furthermore, the support base 40 and the dispensing container 34 can be arranged along the second direction, and the first peristaltic pump 121 and the second peristaltic pump 322 can both be located on the same side of the support base 40 and the dispensing container 34, so as to facilitate the connection between the first conveyor 11 and the second reaction container 50 and the second conveyor 31 and the dispensing container 34, which can avoid the first conveyor 11 and the second conveyor 31 from getting tangled and crossing, and is conducive to improving the aesthetics and operability of the drug production system 100.

[0130] According to some embodiments of the present invention, such as Figure 3 As shown, the drug dispensing device 30 further includes: a second shielding and radiation protection structure 33, which is used to place the dispensing container 34. The second shielding and radiation protection structure 33 forms a shielding groove with one end open, which is used to place the dispensing container 34.

[0131] The second radiation shielding structure 33 can be made of shielding materials such as iron, copper, tungsten, and lead. When the dispensing container 34 contains radioactive drugs, the second radiation shielding structure 33 is used to place the dispensing container 34, providing enhanced shielding and effectively blocking and absorbing radiation from the radioactive drugs within it, thus providing more comprehensive protection for medical personnel. When the drugs in the dispensing container 34 are not radioactive, the second radiation shielding structure 33 also provides stable support and protection for the dispensing container 34, preventing damage during the storage of synthetic drugs and protecting it from external physical impacts and chemical corrosion to a certain extent, thereby ensuring the technical efficacy and safety of the drugs. Furthermore, by setting up a second shielding and radiation protection structure 33 to provide targeted protection for the dispensing container 34, the overall protective material requirements for the external environment of the drug production system 100 can be reduced. In application scenarios, this is specifically manifested as a hot chamber, which in turn reduces the overall weight of the drug production system 100 and the external hot chamber, thereby reducing the load-bearing capacity of the floor where the drug production system 100 and the external hot chamber are located.

[0132] like Figure 3 As shown, the second shielding and radiation protection structure 33 forms a shielding groove with one end open. The shielding groove is used to place the dispensing container 34. The open shielding groove allows the dispensing container 34 to be easily put in and taken out without complicated operations or additional tools. The open shielding groove is also suitable for dispensing containers 34 of various types and specifications, and has high versatility and adaptability.

[0133] According to some embodiments of the present invention, such as Figure 7B As shown, the drug production system 100 also includes a first activity detection device 51, which is used to detect the drug activity in the dispensing container 34.

[0134] The first activity detection device 51 can be an activity probe, activity sensor, or other similar device. It can be mounted on the dispensing container 34 to detect the drug activity within the container. Detecting the drug activity within the container 34 using the first activity detection device 51 provides the activity value of the monitored drug, feeding back drug information (such as activity, volume, and mass, where volume and mass can be calculated using formulas). This provides effective data support for drug dispensing, improving the accuracy and reliability of the dispensing process. When the drug activity in the dispensing container 34 reaches a preset value, the second drive mechanism 32 stops driving the drug in the second reaction container 50 to flow into the dispensing container 34 along the second conveying assembly, and disconnects the second reaction container 50 from the dispensing container 34. Specifically, the multi-port component 311 is disconnected from the dispensing container 34 to achieve the correct dosage dispensing of the drug.

[0135] Furthermore, the volume parameters of the drug can be preset for the second drive mechanism 32. The second drive mechanism 32 can also flow the drug in the second reaction container 50 into the dispensing container 34 along the second conveying assembly according to the preset drug volume parameters. When the volume of the drug in the dispensing container 34 reaches the preset drug volume parameters, the second drive mechanism 32 stops working to disconnect the second reaction container 50 from the dispensing container 34. Specifically, the multi-port component 311 is disconnected from the dispensing container 34 to achieve quantitative dispensing of the drug.

[0136] According to some embodiments of the present invention, such as Figure 7B As shown, the first activity detection device 51 can be adjacent to the dispensing container 34, which facilitates the first activity detection device 51 to monitor the drug in the dispensing container 34, helps to detect changes in drug activity in a timely manner, and thus take necessary measures to ensure the quality and safety of the drug.

[0137] According to some embodiments of the present invention, such as Figure 4 and Figure 5 As shown, the pin assembly 20 includes: a first pin 21 and a second pin 22, wherein the length of the first pin 21 is greater than the length of the second pin 22; When the pin assembly 20 is in the first position, the first pin 21 is inserted into the second reaction vessel 50 and remains separated from the prepared solvent in the second reaction vessel 50 during the synthesis process, so that the gas in the second reaction vessel 50 can be discharged through the first pin 21. In the second position, the first needle 21 and the second needle 22 are both inserted into the second reaction container 50, and the first needle 21 is inserted into the synthesized drug so that the synthesized drug is discharged through the first needle 21. The second needle 22 is kept apart from the synthesized drug during the dispensing process so that the gas outside the second reaction container 50 enters the second reaction container 50 through the second needle 22.

[0138] In the first position, the first pin 21 of the pin assembly 20 is inserted into the second reaction vessel 50 and remains separated from the solvent in the second reaction vessel 50 during the synthesis process, so that the gas in the second reaction vessel 50 can be discharged through the first pin 21, ensuring the pressure balance inside and outside the second reaction vessel 50. Specifically, the first pin 21 is connected to the second conveyor 31, and the second conveyor 31 is connected to the multi-port 311. When venting is carried out through the first pin 21, the multi-port 311 is separated from the dispensing container 34, so that the gas in the second reaction vessel 50 can be discharged through the first pin 21, the second conveyor 31, and the multi-port 311.

[0139] In the second position, the needle assembly 20 has both the first needle 21 and the second needle 22 inserted into the second reaction container 50. The first needle 21 is inserted into the synthesized drug so that the synthesized drug can be discharged through the first needle 21. The second needle 22 remains separated from the synthesized drug during the dispensing process so that gas outside the second reaction container 50 can enter the second reaction container 50 through the second needle 22, ensuring pressure balance inside and outside the second reaction container 50. Specifically, the first needle 21 is connected to the second conveyor 31, and the second conveyor 31 is connected to the multi-port 311. When the first needle 21 is inserted into the synthesized drug, the multi-port 311 is connected to the dispensing container 34 so that the synthesized drug in the second reaction container 50 can be dispensed into the dispensing container 34 through the first needle 21, the second conveyor 31, and the multi-port 311, realizing the dispensing of the synthesized drug. The second needle 22 remains separated from the synthesized drug during the dispensing process so that gas outside the second reaction container 50 can enter the second reaction container 50 through the second needle 22.

[0140] According to some embodiments of the present invention, such as Figure 4 As shown, in a first embodiment of the pin assembly 20 of the present invention, the inner diameter of the second pin 22 is larger than the outer diameter of the first pin 21. The second pin 22 is sleeved on the outside of the first pin 21, and the first pin 21 and the second pin 22 are spaced apart to form a gap between the first pin 21 and the second pin 22, so that gas outside the second reaction container 50 can enter the second reaction container 50 through the gap.

[0141] The inner diameter of the second pin 22 is larger than the outer diameter of the first pin 21. The second pin 22 is sleeved outside the first pin 21. The length of the first pin 21 is greater than that of the second pin 22. The first pin 21 and the second pin 22 are spaced apart to form a gap between the first pin 21 and the second pin 22, so that the gas outside the second reaction container 50 can enter the second reaction container 50 through the gap. This ensures that the gas pressure inside and outside the second reaction container 50 is balanced during the drug synthesis and dispensing process. It can also completely remove the synthesized drug from the second reaction container 50, avoid residue and waste, and improve the safety and reliability of the drug production system 100.

[0142] According to some embodiments of the present invention, such as Figure 5As shown, in a second embodiment of the pin assembly 20 of the present invention, the first pin 21 and the second pin 22 can be independent of each other. The first pin 21 and the second pin 22 are respectively inserted into the second reaction vessel 50. The length of the first pin 21 is greater than the length of the second pin 22. The second pin 22 is always kept separate from the synthesized drug. During venting, the first pin 21 is kept separate from the synthesized drug so that the gas inside the second reaction vessel 50 can be discharged through the first pin 21. During dispensing of the synthesized drug, the first pin 21 is inserted into the synthesized drug so that the synthesized drug can be discharged through the first pin 21. The second pin 22 remains separated from the synthesized drug during the dispensing process so that gas outside the second reaction vessel 50 can enter the second reaction vessel 50 through the second pin 22.

[0143] In some embodiments of the present invention, the drug production system 100 may further include a control module for controlling the movement of the needle assembly 20. The control module can determine the depth to which the needle assembly 20 is inserted into the second reaction container 50 to reach the first position based on at least one or more parameters, such as the height of the second reaction container 50, the height from the neck to the bottom of the second reaction container 50, the thickness of the rubber stopper sealing the mouth of the second reaction container 50, the volume of reactants injected into the second reaction container 50, and the original volume of the second reactants in the second reaction container 50. These parameters can be input by the user or automatically identified, thereby improving the automation and intelligence of the drug production system 100 and precisely controlling the depth to which the needle assembly 20 is inserted into the second reaction container 50. That is, during synthesis, it is ensured that the first needle 21 pierces the rubber stopper at the first position to balance the internal and external air pressure of the second reaction container 50, while also ensuring that the first needle 21 does not extend into the reactants in the second reaction container 50. It should be noted that the thickness of the rubber stopper sealing the mouth of the second reaction container 50 specifically refers to the distance that the first needle needs to move when the first needle pierces the rubber stopper to connect with the second reaction container. It should be noted that the thickness of the rubber stopper sealing the mouth of the second reaction vessel 50 specifically refers to the distance that the first needle needs to move when the first needle pierces the rubber stopper and connects the first needle with the second reaction vessel.

[0144] According to some embodiments of the present invention, the pressure change within a predetermined time when the rubber stopper is punctured can be captured by a pressure sensor to determine whether the insert assembly 20 has punctured the rubber stopper, thereby ensuring that the internal and external pressure of the second reaction vessel 50 is balanced.

[0145] According to some embodiments of the present invention, there is a length difference A between the first pin 21 and the second pin 22, the height from the bottleneck to the bottom of the second reaction vessel 50 is h1, and the thickness of the rubber stopper sealing the mouth of the second reaction vessel 50 is h2, which can have the following relationship with the height h3 of the final solvent in the second reaction vessel: h2≤A≤h1 and / or h1-h2≤A≤h1 and / or h3≤A≤h1, that is, A only needs to satisfy any one of the following relations: h2≤A≤h1, h1-h2≤A≤h1, h3≤A≤h1. Alternatively, A only needs to satisfy any two of the following relations: h2≤A≤h1, h1-h2≤A≤h1, h3≤A≤h1. Or A needs to satisfy all three relations: h2≤A≤h1, h1-h2≤A≤h1, h3≤A≤h1. The appropriate settings can be made according to the actual situation.

[0146] According to some embodiments of the present invention, during the synthesis process, both the first driving mechanism 12 and the second driving mechanism 32 are working and the multi-port 311 is separated from the dispensing container 34, so that when the first reactant in the first reaction container 16 flows into the second reaction container 50, the gas in the second reaction container 50 is discharged through the pin assembly 20 and the multi-port 311.

[0147] During the synthesis process, both the first driving mechanism 12 and the second driving mechanism 32 are working and the multi-port 311 is separated from the dispensing container 34. This allows the first reactant in the first reaction container 16 to flow into the second reaction container 50, while the gas in the second reaction container 50 is discharged through the needle assembly 20 and the multi-port 311. This balances the gas pressure inside and outside the second reaction container 50, reduces the risk of the second reaction container 50 rupture or reduced sealing, improves the automation level of the drug production system 100, reduces the contact between medical personnel and drugs, and greatly reduces the radiation hazards of radiopharmaceuticals to medical personnel.

[0148] like Figure 1 and Figure 2 As shown, the isolation cabinet 200 according to an embodiment of the present invention includes: The drug production system 100 is the drug production system 100 described in the above embodiment. The cabinet houses the drug production system 100.

[0149] The isolation cabinet 200 can be made of shielding materials such as iron, copper, tungsten, and lead. The first activity detection device 51 and the drug production system 100 can both be located inside the isolation cabinet 200, effectively isolating them from the external environment and shielding the radiopharmaceuticals within, thus protecting medical personnel from potential health hazards. Furthermore, the isolation cabinet 200 can have multiple through-holes 201, each with a shielding cover 202 for sealing. When it is necessary to retrieve or place medications or objects from the isolation cabinet 200, the shielding cover 202 can be opened to allow medical personnel to reach into the cabinet through the through-holes 201, thus effectively protecting them from potential health hazards by reducing the radiation dose.

[0150] The isolation cabinet 200 may also be equipped with a controller 203. The controller 203 can communicate with the first conveyor 11, the first drive mechanism 12, the second conveyor 31, the second drive mechanism 32, the first drive module 13, the second drive module 14, and the third drive module 15. Medical personnel can control the operation of the first conveyor 11, the first drive mechanism 12, the second conveyor 31, the second drive mechanism 32, the first drive module 13, the second drive module 14, and the third drive module 15 through the controller 203 to complete the synthesis and packaging of drugs. This greatly improves the automation level of the drug production system 100, further reduces the contact between medical personnel and radiopharmaceuticals, reduces the radiation dose of radiopharmaceuticals to medical personnel, improves the protective effect on medical personnel, and also reduces the labor intensity of medical personnel.

[0151] Furthermore, as a specific embodiment of this application, the drug production system 100 of this application may include one or more of the following steps in the drug synthesis and packaging steps. The order of the steps may be changed as needed. The steps are only listed here and the specific order of the steps is not limited: The first drive module 13 moves the second reaction container 50 relative to the pin assembly 20 to move the pin assembly 20 to a first position. At the first position, the first pin 21 of the pin assembly 20 is inserted into the second reaction container 50 (e.g., the gripper 17 drives the second reaction container 50 to move toward the pin assembly 20 so that the pin assembly 20 is inserted into the second reaction container 50). The first peristaltic pump 121 drives the preparation reagent (e.g., 5 ml of hydrochloric acid) to flow through the nuclide generator 215 and into the second reaction vessel 50, realizing the rinsing function of the nuclide generator 215. The first reactant (e.g., radioactive isotope) rinsed off flows into the second reaction vessel 50 through the first pipeline 111 and mixes with the second reactant in the second reaction vessel 50 to form the preparation solvent. The gas in the second reaction vessel 50 is discharged through the first needle 21 to balance the gas pressure inside and outside the second reaction vessel 50. During the rinsing process, the first needle 21 is separated from the preparation solvent in the second reaction vessel 50. The second reaction vessel 50 is moved away from the pin assembly 20 by the first drive module 13 (e.g., gripper 17); The second reaction container 50 is driven to reciprocate along the first direction by the first drive module 13 (e.g., gripper 17) to mix the prepared solvent in the second reaction container 50 and synthesize the drug in the second reaction container. The second reaction container 50 continues to move relative to the pin assembly 20 to a second position via the first drive module 13 (e.g., gripper 17). At the second position, the first pin 21 is inserted into the synthetic drug inside the second reaction container 50, and the second pin 22 of the pin assembly 20 is spaced apart from the preparation solvent. The third drive module 15 drives the multi-port 311 to connect with the dispensing container 34, and the second peristaltic pump 322 drives the synthetic drug to be delivered into the dispensing container 34 through the first insert 21, the second pipeline 313 and the multi-port 311. After setting the dispensing activity or volume parameters, when the preset amount of mixed drug in the dispensing container 34 is reached, the second peristaltic pump 322 (second drive mechanism 32) stops working. The third drive module 15 drives the multi-channel component 311 to separate from the dispensing container 34, and places the dispensing container 34 into the first activity detection device 51 for activity detection. Once the activity detection value reaches the standard, the dispensing is completed in one go.

[0152] According to some embodiments of the present invention, after or simultaneously with the first drive module 13 moving the second reaction vessel 50, the following steps are also included: The second drive module 14 drives the first shielding and radiation protection structure 23 to move synchronously with the second reaction container 50.

[0153] According to some embodiments of the present invention, after shaking and preparing the solvent, one or more of the following steps may be included. The order of the steps may be changed as needed. The steps are only listed here and the specific order of the steps is not limited: The second reaction container 50 is moved toward the support base 40 by the first drive module 13 so that the second reaction container 50 is moved into the placement space 41 of the support base 40; The second reaction vessel 50 is placed in the placement space 41 of the support 40 and left to stand for a period of time to wait for drug synthesis.

[0154] According to some embodiments of the present invention, after shaking and preparing the solvent, one or more of the following steps may be included. The order of the steps may be changed as needed. The steps are only listed here and the specific order of the steps is not limited: The second reaction container 50 is moved toward the support base 40 by the first drive module 13 so that the second reaction container 50 is moved into the placement space 41 of the support base 40; The heating device 24 inside the support 40 heats the second reaction vessel 50, accelerating the synthesis; The second reaction vessel 50 is cooled by the heat dissipation device 25.

[0155] According to some embodiments of the present invention, the following steps are included before cooling the second reaction vessel 50 by the heat dissipation device 25: The second reaction vessel 50 is moved away from the support base 40 by the gripper 17, thus removing the second reaction vessel 50 from the placement space 41 of the support base 40. This process ensures that the heat dissipation device 25 cools only the second reaction vessel 50 and does not cool the heating device, thereby improving heating efficiency.

[0156] According to some embodiments of the present invention, before the synthetic drug is delivered into the dispensing container 34 (i.e., after the multi-port 311 is connected to the dispensing container 34), an emptying process is further included, the emptying process comprising the following steps: The third drive module 15 drives the multi-port component 311 to connect with the dispensing container 34, and the second peristaltic pump 322 delivers part of the synthetic drug from the second reaction container 50 into the dispensing container 34 to purge the air in the second pipeline 313. The multi-channel component 311 is separated from the dispensing container 34 by the third drive module 15; Replace with new dispensing containers 34; The third drive module 15 drives the multi-channel component 311 to connect with the new dispensing container 34 to deliver the synthetic drug from the second reaction container 50 into the dispensing container 34. During the delivery process, the second insertion pin 22 connects with the outside to balance the air pressure inside and outside the second reaction container 50.

[0157] According to some embodiments of the present invention, before the drug synthesis and packaging steps begin, one or more of the following steps may be included. The order of these steps may be changed as needed. This is merely a list of steps and does not limit the specific order of the steps: Perform a 100% self-inspection on the drug production system to check whether all functions of the system can be used normally and eliminate potential faults in advance; Add the required amount of drug powder into the second reaction container 50, and inject 1 ml of water for injection into the second reaction container 50. After thoroughly shaking and dissolving the powder, install the second reaction container 50 onto the support base 40. Connect the reagent preparation to the generator inlet 212 of the nuclide generator 215; One end of the first pipe 111 is connected to the generator outlet 213 of the nuclide generator 215, and at least a portion of the first pipe 111 is installed in the first extrusion groove 214 of the first peristaltic pump 121, and the other end of the first pipe 111 is connected to the second reaction vessel 50. One end of the second conduit 313 is connected to the first pin 21, and the second conduit 313 is installed at least partially within the second extrusion groove 321 of the second peristaltic pump 322. The other end of the second conduit 313 is connected to the multi-port connector 311, which remains disconnected from the dispensing container 34. The pin assembly 20 is then installed in place. By pre-connecting and installing all conduits and components, subsequent operations are completed by each module, reducing human intervention, achieving a high degree of automation, and avoiding radiation-induced harm to the human body.

[0158] According to some embodiments of the present invention, after the preparation process and before the drug synthesis and dispensing steps, the following steps may be included: starting the first peristaltic pump 121 and the second peristaltic pump 322 so that during the rinsing process, the gas in the second reaction vessel 50 is discharged through the first insert 21, the second pipeline 313 and the multi-port 311.

[0159] According to some embodiments of the present invention, the following steps may be included before the drug synthesis and packaging steps begin: If necessary, the heating device 24 is activated for preheating. This preheating process saves time in reaching the predetermined temperature and improves drug production efficiency.

[0160] The drug manufacturing method according to embodiments of the present invention, such as Figure 1-9 As shown, the drug production system 100 applied in the above embodiment includes the following steps in its drug production method: S1: The second reaction container 50 is moved relative to the pin assembly 20 by the first drive module 13 so that the pin assembly 20 is moved to a first position. In the first position, the first pin 21 of the pin assembly 20 is inserted into the second reaction container 50.

[0161] In this process, the needle assembly 20 is moved to the first position during drug synthesis. This ensures that the first needle 21 punctures the rubber stopper in the first position, thereby balancing the internal and external air pressure of the second reaction container 50, and also ensures that the first needle 21 does not extend into the reactants in the second reaction container 50.

[0162] S2: The first peristaltic pump 121 drives the preparation reagent to flow through the nuclide generator 215 and the first reactant washed off flows into the second reaction vessel 50 through the first pipeline 111. It mixes with the second reactant in the second reaction vessel 50 to form the preparation solvent. The gas in the second reaction vessel 50 is discharged through the first needle 21. During the washing process, the first needle 21 is separated from the preparation solvent in the second reaction vessel 50.

[0163] In this process, a first peristaltic pump 121 drives the preparation reagent (e.g., 5 ml of hydrochloric acid) to flow through the nuclide generator 215 and into the second reaction vessel 50, thus achieving the rinsing function of the nuclide generator 215. The rinsed first reactant (e.g., a radioactive isotope) flows into the second reaction vessel 50 through the first conduit 111, where it mixes with the second reactant in the second reaction vessel 50 to form the preparation solvent. Gas inside the second reaction vessel 50 is discharged through the first needle 21 to balance the gas pressure inside and outside the second reaction vessel 50. During the rinsing process, the first needle 21 is separated from the preparation solvent in the second reaction vessel 50.

[0164] S3: Drive the second reaction vessel 50 to move away from the pin assembly 20 via the first drive module 13.

[0165] Specifically, the second reaction container 50 is driven by the first drive module 13 to move away from the pin assembly 20, so that the pin assembly 20 is pulled out of the second reaction container 50.

[0166] S4: The second reaction container 50 is driven to reciprocate along the first direction by the first driving module 13 to mix the prepared solvent in the second reaction container 50, and a synthetic drug is formed in the second reaction container 50.

[0167] Specifically, the first drive module 13 drives the second reaction container 50 to reciprocate along a first direction, thereby thoroughly mixing the drug in that direction. The first and second reactants within the second reaction container 50 undergo continuous agitation in the first direction, facilitating mixing. This automated mixing process is more efficient than manual operation, enabling the mixing of large quantities of drug in a short time, thus improving production efficiency. Furthermore, the uniformly mixed drug exhibits more stable efficacy during subsequent dispensing and use, contributing to improved final product quality.

[0168] S5: The second reaction container 50 continues to move relative to the pin assembly 20 through the first drive module 13 so that the pin assembly 20 moves to the second position. At the second position, the first pin 21 is inserted into the synthetic drug in the second reaction container 50, and the second pin 22 of the pin assembly 20 is separated from the preparation solvent.

[0169] In the second position, the first needle 21 and the second needle 22 are both inserted into the second reaction container 50. The first needle 21 is inserted into the synthesized drug so that the synthesized drug is discharged through the first needle 21. The second needle 22 is kept separate from the prepared solvent during the dispensing process so that the gas outside the second reaction container 50 enters the second reaction container 50 through the second needle 22, ensuring the gas pressure inside and outside the second reaction container 50 is balanced.

[0170] S6: The third drive module 15 drives the multi-port 311 to connect with the dispensing container 34, and the second peristaltic pump 322 drives the synthetic drug to be delivered into the dispensing container 34 through the first insert 21, the second pipeline 313 and the multi-port 311.

[0171] The third drive module 15 can drive the mounting base 312 to move the multi-channel component 311. When the third drive module 15 moves, the mounting base 312 and the third drive module 15 move synchronously to drive the multi-channel component 311 to move synchronously, so as to achieve the effect of connecting the multi-channel component 311 with the dispensing container 34. When the multi-channel component 311 is connected to the dispensing container 34, the second peristaltic pump 322 drives the synthetic drug to be delivered to the dispensing container 34 through the first insertion needle 21, the second pipeline 313 and the multi-channel component 311, thereby realizing the dispensing of the drug, improving the automation level of the drug production system 100, reducing the contact between medical personnel and drugs, and greatly reducing the radiation hazards of radioactive drugs to medical personnel.

[0172] S7: After setting the dispensing activity or volume parameters, when the preset amount of synthetic drug in the dispensing container 34 is reached, the second peristaltic pump 322 stops working.

[0173] When the preset amount of synthetic drug in the dispensing container 34 reaches the target value, the second peristaltic pump 322 stops working and stops delivering synthetic drug into the dispensing container 34.

[0174] S8: The third drive module 15 drives the multi-channel component 311 to separate from the dispensing container 34, and places the dispensing container 34 into the first activity detection device 51 for activity detection. Once the activity detection value reaches the standard, the dispensing is completed in one go.

[0175] According to an embodiment of the present invention, the drug manufacturing method further includes, or is further comprising, the following steps after or simultaneously with the first drive module 13 moving the second reaction vessel 50: The second drive module 14 drives the first shielding and radiation protection structure 23 to move synchronously with the second reaction container 50.

[0176] The second drive module 14 is activated to drive the first shielding radiation protection structure 23 to move synchronously with the second reaction container 50. This ensures that the first shielding radiation protection structure 23 always covers the second reaction container 50, eliminating protective gaps caused by the movement of the second reaction container 50, thereby reducing the radiation hazard of radiopharmaceuticals to operators.

[0177] According to the drug production method of the present invention, step S4, after shaking and preparing the solvent, further includes the following steps: S4.1: Drive the second reaction container 50 toward the support base 40 through the first drive module 13 so that the second reaction container 50 moves into the placement space 41 of the support base 40.

[0178] The placement space 41 is matched with the shape of the second reaction vessel 50 so that the placement space 41 is used to place the second reaction vessel 50.

[0179] S4.2: Place the second reaction vessel 50 in the placement space 41 and let it stand for a period of time to wait for drug synthesis.

[0180] The second reaction container 50 is placed in the placement space 41. The settling time of the second reaction container 50 in the placement space 41 can be reasonably selected and set according to the actual situation. By placing the second reaction container 50 in the placement space 41 for a period of time, sufficient time can be given for drug synthesis, which is conducive to improving the quality of drug synthesis.

[0181] According to the drug production method of the present invention, step S4, after shaking and preparing the solvent, further includes the following steps: S4(a): Drive the second reaction container 50 toward the support base 40 by the first drive module 13 so that the second reaction container 50 moves into the placement space 41 of the support base 40.

[0182] S4(b): The heating device 24 inside the support 40 heats the second reaction vessel 50.

[0183] After the solvent is shaken and mixed, the first drive module 13 drives the second reaction vessel 50 to move into the placement space 41 of the support base 40. Then, the heating device 24 in the support base 40 heats the second reaction vessel 50 to accelerate drug synthesis.

[0184] S4(c): The first drive module 13 drives the second reaction vessel 50 to move away from the support 40.

[0185] The first drive module 13 drives the second reaction container 50 to move away from the support base 40, thereby moving the second reaction container 50 out of the placement space 41.

[0186] S4(d): During the movement, the heat dissipation device 25 cools the second reaction vessel 50.

[0187] During the process of the first drive module 13 driving the second reaction container 50 to move away from the support base 40, the heat dissipation device 25 acts directly on the second reaction container 50, which can effectively remove the heat of the second reaction container 50 and the mixed reactants inside, achieve the cooling effect, provide strong support for the cooling treatment of the drug, and ensure the quality and efficacy of the drug.

[0188] According to the drug manufacturing method of the present invention, after connecting the multi-port connector 311 to the dispensing container 34 in step S6, a venting process is further included, which includes the following steps: S6.1: The second peristaltic pump 322 delivers a portion of the synthesized drug from the second reaction vessel 50 to the dispensing container 34 to purge the air from the second pipeline 313.

[0189] In step S6, after the multi-port 311 is connected to the dispensing container 34, the second peristaltic pump 322 works to transport part of the synthetic drug from the second reaction container 50 into the dispensing container 34. During the process of the synthetic drug flowing into the dispensing container 34, the air in the second pipeline 313 can be discharged, thus achieving the effect of air discharge from the second pipeline 313.

[0190] S6.2: The multi-channel component 311 is separated from the dispensing container 34 by the third drive module 15.

[0191] The third drive module 15 drives the multi-channel component 311 to separate from the packaging container 34, thereby disconnecting the multi-channel component 311 from the packaging container 34.

[0192] S6.3: Replace with a new dispensing container 34.

[0193] S6.4: The multi-channel component 311 is connected to the new dispensing container 34 via the third drive module 15, and the synthetic drug in the second reaction container 50 is delivered to the new dispensing container 34 via the second peristaltic pump 322.

[0194] When the new dispensing container 34 is replaced, the third drive module 15 drives the multi-channel component 311 to connect with the new dispensing container 34, and the second peristaltic pump 322 works to transport the synthetic drug in the second reaction container 50 to the new dispensing container 34.

[0195] According to an embodiment of the present invention, the drug manufacturing method may further include a preparation process for the drug manufacturing system 100 before step S1, the process specifically including the following steps: S0.1: 100% self-inspection of the drug production system.

[0196] Among them, the drug production system 100 is self-tested to check whether the various functions of the drug production system 100 can be used normally and to eliminate potential faults in advance.

[0197] S0.2: Add the required amount of drug powder into the second reaction container 50, and inject water for injection into the second reaction container 50. After thoroughly shaking and dissolving the powder, install the second reaction container 50 onto the support base 40.

[0198] For example, the required amount of drug powder is added to the second reaction container 50, and 1 ml of water for injection is injected into the second reaction container 50. After the mixture is thoroughly shaken and dissolved, the second reaction container 50 is installed on the support base 40.

[0199] S0.3: Connect the reagent preparation to the generator inlet 212 of the nuclide generator 215.

[0200] The reagent is connected to the generator inlet 212 of the nuclide generator 215, thereby connecting the reagent to the nuclide generator 215.

[0201] S0.4: Connect one end of the first pipe 111 to the generator outlet 213 of the nuclide generator 215, install at least a portion of the first pipe 111 in the first extrusion groove 214 of the first peristaltic pump 121, and connect the other end of the first pipe 111 to the second reaction vessel 50.

[0202] Specifically, one end of the first pipe 111 is connected to the generator outlet 213 of the nuclide generator 215, thereby connecting the first pipe 111 to the nuclide generator 215. The other end of the first pipe 111 is connected to the second reaction vessel 50, achieving the effect of connecting the first pipe 111 to the nuclide generator 215 and the second reaction vessel 50. At least a portion of the first pipe 111 is installed in the first extrusion groove 214 of the first peristaltic pump 121. When the first peristaltic pump 121 is working, it can drive the preparation reagent to flow through the nuclide generator 215 and the first reactant washed off flows into the second reaction vessel 50 through the first pipe 111, where it mixes with the second reactant in the second reaction vessel 50 to form the preparation solvent.

[0203] S0.5: Connect one end of the second pipe 313 to the first pin 21, and install at least a portion of the second pipe 313 into the second extrusion groove 321 of the second peristaltic pump 322, and connect the other end of the second pipe 313 to the multi-port 311, with the multi-port 311 kept disconnected from the dispensing container 34.

[0204] The second conduit 313 is used to connect the first insert 21 and the multi-port 311. At least a portion of the second conduit 313 is installed in the second extrusion groove 321 of the second peristaltic pump 322 so that the second peristaltic pump 322 delivers the synthetic drug by extruding the second conduit 313.

[0205] S0.6: Install the pin assembly 20 into place.

[0206] The pin assembly 20 is fixedly installed on the corresponding component. All pipelines and components are connected and installed in advance, and subsequent operations are completed by each module, reducing human intervention, achieving a high degree of automation, and avoiding radiation-related harm to the human body.

[0207] According to the drug production method of the present invention, after the preparation process and before step S1, the following steps may be included: starting the first peristaltic pump 121 and the second peristaltic pump 322 so that during the rinsing process, the gas in the second reaction vessel 50 is discharged through the first insert 21, the second pipeline 313 and the multi-port 311.

[0208] After the preparation process and before step S1, the first peristaltic pump 121 and the second peristaltic pump 322 are started so that the drug production system 100 discharges the gas in the second reaction container 50 through the first insert 21, the second pipeline 313 and the multi-port 311 during the rinsing process, thereby balancing the gas pressure inside and outside the second reaction container 50.

[0209] According to the drug production method of the present invention, before step S1, the following step may be included: starting the heating device 24 for preheating.

[0210] In this process, the heating device 24 is preheated before step S1, which saves the time for the heating device 24 to reach the predetermined temperature and shortens the preheating waiting time. The heating device 24 can immediately heat the second reaction vessel 50, shorten the drug synthesis time, improve the drug heating efficiency of the drug production system 100, and improve the drug production efficiency.

[0211] The drug manufacturing method according to embodiments of the present invention, such as Figure 1-9 As shown, the drug production system 100 applied in the above embodiments includes the following method: S101, control the movement of the second reaction container 50 relative to the pin assembly 20 so that the pin assembly 20 is inserted into or removed from the second reaction container 50.

[0212] Specifically, the second reaction container 50 can be driven to move relative to the pin assembly 20 along a first direction by the first drive module 13, so that the pin assembly 20 can be inserted into or removed from the second reaction container 50. The first drive module 13 may include a motor, a lead screw module, and a gripper 17. The motor serves as a power source to drive the lead screw module and gripper 17, providing power for the reciprocating movement of the second reaction container 50 along the first direction. The lead screw module displaces the gripper 17, meeting the high-precision requirements for the position of the second reaction container 50. The gripper 17 is used to grasp, move, and place the second reaction container 50, which is simple and quick, reducing operational difficulty and time costs.

[0213] By controlling the movement of the second reaction container 50 toward the pin assembly 20, the pin assembly 20 is inserted into the second reaction container 50, and the pin assembly 20 is kept separated from the solvent in the second reaction container 50. As the first reactant flows into the second reaction container 50 along the first conveyor 11, the gas in the second reaction container 50 can be discharged through the pin assembly 20 to balance the gas pressure inside and outside the second reaction container 50 and reduce the risk of the second reaction container 50 rupture or reduced sealing.

[0214] Furthermore, by controlling the movement of the second reaction container 50 away from the needle assembly 20, so that the needle assembly 20 is pulled out of the second reaction container 50, the first drive module 13 can drive the second reaction container 50 to reciprocate along the first direction, so as to shake and mix the drug in the second reaction container 50, and complete the synthesis of the drug.

[0215] Furthermore, by controlling the second reaction container 50 to move toward the needle assembly 20, so that the needle assembly 20 is inserted into the second reaction container 50 and the needle assembly 20 is inserted into the synthetic drug inside the second reaction container, the synthetic drug inside the second reaction container 50 can be delivered through the needle assembly 20 to dispense or store the synthetic drug.

[0216] S102, during the synthesis process, after the needle assembly 20 is inserted into the first position in the second reaction container 50, the first drive mechanism 12 of the drug synthesis device 10 is activated, so that the first drive mechanism 12 cooperates with the first conveyor 11 to drive the first reactant to flow into the second reaction container 50 along the first conveyor 11 for synthesis, and the gas in the second reaction container 50 is discharged through the needle assembly 20.

[0217] During the synthesis process, after the needle assembly 20 is inserted into the first position inside the second reaction container 50, the needle assembly 20 remains separated from the solvent in the second reaction container 50. The first drive mechanism 12 of the drug synthesis device 10 is activated, so that the first drive mechanism 12 cooperates with the first conveying member 11 to drive the first reactant to flow into the second reaction container 50 along the first conveying member 11 for synthesis. The gas in the second reaction container 50 is discharged through the needle assembly 20 to balance the gas pressure inside and outside the second reaction container 50, reduce the risk of the second reaction container breaking or reduced sealing, and also ensure that the first reactant is smoothly delivered into the second reaction container to mix with the second reactant and synthesize the drug.

[0218] S103, during the dispensing process, after the control needle assembly 20 is inserted into the second position inside the second reaction container 50, the control second drive mechanism 32 of the drug dispensing device 30 is activated, so that the second drive mechanism 32 cooperates with the second conveyor 31 to drive the synthesized drug through the needle assembly 20 and flow into the dispensing container 34 along the second conveyor 31, and the gas outside the second reaction container 50 flows into the second reaction container 50 through the needle assembly 20.

[0219] During the dispensing process, after the needle assembly 20 is inserted into the second position inside the second reaction container 50, the needle assembly 20 is inserted into the synthetic drug inside the second reaction container 50. The second drive mechanism 32 of the drug dispensing device 30 is then activated, so that the second drive mechanism 32 cooperates with the second conveyor 31 to drive the synthesized drug through the needle assembly 20 and flow into the dispensing container 34 along the second conveyor 31. At the same time, the gas outside the second reaction container 50 flows into the second reaction container 50 through the needle assembly 20 to balance the gas pressure inside and outside the second reaction container 50. This can completely remove the synthesized drug from the second reaction container, avoid residue and waste, and improve the safety and reliability of the drug production system 100, thus realizing the dispensing of the synthetic drug.

[0220] According to some embodiments of the present invention, the drug production system further includes: a first drive module 13; The method also includes: The first drive module 13 is activated, and the first drive module 13 drives the second reaction container 50 to move so that the first reactant and the second reactant in the second reaction container 50 are mixed.

[0221] The first drive module 13 is activated, and the first drive module 13 may include a motor, a lead screw module, a gripper 17 and other structures. The first drive module 13 can drive the second reaction container 50 to move (such as rotation, shaking, translation and other forms of movement) to promote the full mixing of the first reactant and the second reactant in the second reaction container, thereby enabling the automatic synthesis of the drug.

[0222] According to some embodiments of the present invention, the first drive module 13 is activated, and the first drive module 13 drives the second reaction container 50 to reciprocate along a first direction so that the first reactant and the second reactant in the second reaction container 50 are mixed; wherein, the first direction is the height direction of the drug production system.

[0223] The system activates the first drive module 13, which drives the second reaction container 50 to reciprocate along a first direction. This reciprocating motion thoroughly mixes the drug within the second reaction container. The continuous agitation of the first and second reactants in the first direction further facilitates mixing. This automated mixing process is more efficient than manual operation, enabling the mixing of large quantities of drug in a short time, thus improving production efficiency. Furthermore, the uniformly mixed drug exhibits more stable efficacy during subsequent packaging and use, contributing to improved final product quality.

[0224] It can be noted that the first direction can be any direction of the drug production system 100, such as the height direction or the lateral direction, as long as the drug can be thoroughly shaken. As a specific embodiment of the present invention, the first direction is the height direction of the drug production system. Setting the first direction as the height direction helps to optimize the spatial layout of the drug production system. By rationally designing the structure of the drug production system, the internal space resources of the drug production system can be fully utilized, reducing the floor area and volume of the equipment.

[0225] According to some embodiments of the present invention, the drug synthesis apparatus 10 further includes a heating device 24; The method also includes: The heating device 24 is activated, and the heating device 24 heats the second reaction vessel 50.

[0226] The heating device can be constructed as an electric heating mantle, electric furnace, electric heating plate, electric steam generator, etc., without specific limitations. Controlling the start of the heating device allows it to heat the second reaction vessel, thereby heating the mixture of the first and second reactants within the second reaction vessel. This provides strong support for the heat treatment of the synthesized drug, fulfilling the requirements of the drug synthesis process and ensuring the quality and efficacy of the drug.

[0227] According to some embodiments of the present invention, the drug production system 100 further includes: a support base 40 and a first drive module 13, wherein the support base 40 is formed with a placement space 41 having an open end; The method also includes: The first drive module 13 is activated, and the first drive module 13 drives the second reaction container 50 to move into the placement space 41; wherein, when the second reaction container 50 is placed in the placement space 41, the neck and mouth of the second reaction container 50 are exposed from the open end of the placement space 41.

[0228] Specifically, the first drive module 13 is activated to drive the second reaction container 50 to move into the placement space 41, so that the second reaction container 50 is stably located on the support 40. This avoids the need for manual placement of the second reaction container and reduces the radioactive hazards to operators when the second reaction container contains radioactive reactants.

[0229] With the second reaction container 50 placed within the placement space, its neck and mouth are exposed from the open end of the placement space 41. This open end eliminates the need for additional steps such as opening the hatch or flipping the lid when moving the second reaction container. The exposed neck and mouth of the second reaction container facilitate smooth gripping of the second reaction container by the first drive module, providing an unobstructed gripping path and enabling automatic transfer of the second reaction container, thus improving the automation level of the drug production system. The exposed neck and mouth of the second reaction container also facilitate the insertion and mating of the needle assembly with the second reaction container, reducing operational errors caused by tilting or obstruction of the second reaction container.

[0230] According to some embodiments of the present invention, the method further includes: The first drive module 13 is activated. After the first drive module 13 clamps the bottleneck and moves it to a position where it does not interfere with the support base 40, it drives the second reaction container 50 to move so that the first reactant and the second reactant in the second reaction container 50 are mixed.

[0231] The system activates the first drive module 13, which, through its gripper 17, moves the bottleneck to a position where it does not interfere with the support base 40. Then, the screw module of the first drive module 13 drives the second reaction container 50 to reciprocate along a first direction, mixing the first and second reactants within the second reaction container 50. This automated mixing process is more efficient than manual operation, enabling the mixing of large quantities of drug in a short time and improving production efficiency. Furthermore, the uniformly mixed drug exhibits more stable efficacy during subsequent packaging and use, contributing to improved final product quality.

[0232] According to some embodiments of the present invention, the drug synthesis apparatus 10 further includes a heating device 24, which is disposed within the support base 40; The method also includes: The heating device 24 is activated, and the heating device 24 heats the second reaction vessel 50.

[0233] The heating device 24 can be housed within the placement space 41 of the support base 40, allowing it to directly contact the second reaction vessel 50. Heating the second reaction vessel with this device reduces air gaps in the heat transfer path, minimizing heat loss, improving heating efficiency, and reducing the need for purchasing, assembling, and debugging independent heating components, thus lowering costs. Furthermore, the heating device 24 and the support base 40 can be integrated seamlessly, resulting in a compact structure that eliminates the need for additional heating plates or hot air modules. The open placement space also ensures convenient loading and unloading of the second reaction vessel.

[0234] The heating device 24 is activated, and the second reaction vessel 50 is heated by the heating device 24. This reduces the air gap in the heat transfer path, helps to reduce heat loss, improves the heating efficiency of the second reaction vessel, and accelerates the synthesis speed of the drug.

[0235] According to some embodiments of the present invention, the drug synthesis apparatus 10 further includes: a heat dissipation device 25, which is fixed to the first drive module 13; The method also includes: After the first drive module 13 drives the second reaction container 50 to move away from the placement space 41, the heat dissipation device 25 is controlled to cool the second reaction container 50.

[0236] The heat dissipation device 25 can be constructed as a fan, heat sink, liquid cooling device, etc., without specific limitations, as long as the heat dissipation device 25 can be used to cool the second reaction container 50. The heat dissipation device 25 acts directly on the second reaction container 50, effectively removing heat from the second reaction container 50 and the mixed reactants inside, achieving a cooling effect. The heat dissipation device 25 is fixed to the first drive module 13. After the first drive module 13 drives the second reaction container 50 to move away from the placement space 41, the heat dissipation device 25 is controlled to cool the second reaction container 50. The heat dissipation device 25 and the second reaction container 50 are correspondingly arranged in the front-back direction (i.e., the Z direction) so that the heat dissipation device 25 can smoothly cool the second reaction container 50. When the first drive module 13 drives the second reaction container 50 to move, the heat dissipation device 25 can simultaneously and smoothly cool the second reaction container 50, providing strong support for the cooling process of the drug and ensuring the quality and efficacy of the drug.

[0237] According to some embodiments of the present invention, the drug synthesis apparatus 10 further includes: a first shielding radiation protection structure 23; The method also includes: The first shielding radiation protection structure 23 is arranged around the second reaction container 50.

[0238] The first radiation shielding structure 23 can be made of shielding materials such as iron, copper, or tungsten, and can be arranged around the second reaction container 50. When the second reaction container 50 contains radioactive reactants, it acts as a shield for the second reaction container 50, effectively shielding the radiation generated by radioactive materials or radiopharmaceuticals, thereby protecting the surrounding environment and the safety of operators. Furthermore, by providing targeted protection for the second reaction container 50 with the first radiation shielding structure 23, the overall protective material requirements for the external environment of the drug production system can be reduced. In application scenarios, this specifically manifests as a hot chamber, thereby reducing the overall weight of the drug production system and the external hot chamber, and consequently reducing the load-bearing capacity of the floor where the drug production system and the external hot chamber are located.

[0239] According to some embodiments of the present invention, the drug synthesis apparatus 10 further includes: a second drive module 14, which is connected to the first shielding and radiation protection structure 23; The method also includes: The second drive module 14 is activated, and the second drive module 14 drives the first shielding and radiation protection structure 23 to move so that the first shielding and radiation protection structure 23 remains around the second reaction container 50.

[0240] The second drive module 14 may include a lead screw module, a slide rail, and other mechanisms. The second drive module 14 and the first shielding and radiation protection structure 23 can be connected by sliding or threaded connections. By controlling the activation of the second drive module 14, the first shielding and radiation protection structure 23 is moved, keeping it positioned around the second reaction container 50. When the second reaction container 50 contains radioactive reactants, the second drive module 14 drives the first shielding and radiation protection structure 23 to move along with the second reaction container 50, ensuring that the first shielding and radiation protection structure 23 always surrounds the second reaction container 50, continuously shielding it and effectively blocking and absorbing radiation from the radioactive reactants within the second reaction container 50, thus providing more comprehensive protection for medical personnel.

[0241] According to some embodiments of the present invention, the method further includes: The second drive module 14 is activated, and the second drive module 14 drives the first shielding radiation protection structure 23 to move in the same direction as the second reaction container 50.

[0242] Specifically, the second drive module 14 is activated to drive the first shielding radiation protection structure 23 to move in the same direction as the second reaction container 50. When the second reaction container 50 is displaced due to demand, the second drive module 14 can drive the first shielding radiation protection structure 23 to move at the same speed and direction, ensuring that the first shielding radiation protection structure 23 always covers the second reaction container 50, avoiding protective gaps caused by the movement of the second reaction container, and thus reducing the radioactive hazards of radiopharmaceuticals to operators.

[0243] According to some embodiments of the present invention, the method further includes: The second drive module 14 is activated, and the second drive module 14 drives the first shielding and radiation protection structure 23 to move synchronously with the second reaction container 50.

[0244] The second drive module 14 is activated to drive the first shielding radiation protection structure 23 to move synchronously with the second reaction container 50. This ensures that the first shielding radiation protection structure 23 always covers the second reaction container 50, eliminates the protective gap caused by the movement of the second reaction container 50, and further reduces the radioactive hazards of radiopharmaceuticals to operators.

[0245] According to some embodiments of the present invention, the first conveying member 11 includes a first pipeline 111, the first driving mechanism 12 includes a first peristaltic pump 121, and the first pipeline 111 connects the first reaction vessel 16 and the second reaction vessel 50. The method also includes: At least a portion of the first conduit 111 is installed within the first extrusion groove 214 of the first peristaltic pump 121.

[0246] The first pipeline 111 is used to connect the first reaction container 16 and the second reaction container 50, thereby enabling the delivery of the first reactant. At least a portion of the first pipeline 111 is installed in the first extrusion groove 214 of the first peristaltic pump 121. The first reactant is delivered by extruding the first pipeline through the first peristaltic pump. The delivery amount of the first reactant can be precisely controlled by adjusting the rotation speed of the first peristaltic pump, so that the first reactant can be delivered from the first reaction container to the second reaction container at a predetermined flow rate and speed, ensuring the quantitative delivery of the drug.

[0247] The working principle of the first peristaltic pump 121 determines the continuity and stability of its delivery process. Since the first pipeline 111 is fixed in the first extrusion groove 214, the extrusion action of the pump head roller on the first pipeline 111 is uniform and stable, thereby avoiding fluctuations and instability of the first reactant during delivery. It also avoids delivering the first reactant through a syringe each time, reducing syringe consumables and preventing the first reactant from remaining in the syringe and contaminating the subsequently synthesized drug. By pushing the liquid in the first pipeline forward through the first peristaltic pump, it will not touch the liquid in the first pipeline, avoiding contamination and residue, thereby improving the stability and reliability of drug synthesis in the drug production system.

[0248] According to some embodiments of the present invention, the first reaction vessel 16 includes: a radionuclide generator 215 and a reagent preparation device, the radionuclide generator 215 having a generator inlet 212 and a generator outlet 213. The method also includes: Connect the generator inlet 212 to the reagent preparation, and connect the generator outlet 213 and the second reaction vessel 50 through the first pipeline 111.

[0249] The nuclide generator 215 has a generator inlet 212 and a generator outlet 213. The generator inlet 212 is used to connect with the reagent preparation, and the generator outlet 213 is connected to the second reaction vessel 50 through the first pipeline 111. The reagent preparation (e.g., 5 ml of hydrochloric acid) can be delivered into the nuclide generator 215 through the generator inlet 212 to achieve rinsing of the nuclide generator 215. The first pipeline 111 is used to connect the generator outlet 213 and the second reaction vessel 50, and the first reactant (e.g., radioactive isotope) that has been rinsed off can be delivered into the second reaction vessel 50 through the generator outlet 213 and the first pipeline 111.

[0250] According to some embodiments of the present invention, the method further includes: In the flow direction of the first reactant within the first conveying member 11, the first peristaltic pump 121 is located downstream of the nuclide generator 215 and upstream of the second reaction vessel 50.

[0251] In this design, the first peristaltic pump 121 is positioned downstream of the nuclide generator 215 and upstream of the second reaction vessel 50, within the first delivery member 11, in the flow direction of the first reactant. This aligns with the flow path of the first reactant, allowing the peristaltic pump 121 to smoothly deliver the first reactant (e.g., a radioactive isotope) rinsed from the nuclide generator 215 through the generator outlet 213 and the first pipeline 111 to the second reaction vessel 50, achieving continuous delivery of the first reactant. Unlike existing technologies that use syringes as a driving source, which result in reactant residue in the syringe and require replacement after each use, the solution in this application reduces reactant residue and lowers the cost of consumable replacement.

[0252] According to some embodiments of the present invention, the drug dispensing device 30 further includes: a multi-port member 311, a second conveying member 31 connecting the needle assembly 20 and the multi-port member 311, and the second conveying member 31 connecting the dispensing container 34 through the multi-port member 311; The method also includes: Control the movement of the multi-port component 311 to connect or disconnect it from the dispensing container 34.

[0253] The multi-port component 311 typically has at least two connection ports. In this embodiment of the invention, the multi-port component has two connection ports, which are respectively connected to the second conveyor component 31 and the dispensing container 34. The second conveyor component 31 is connected to the needle assembly 20 and the multi-port component 311. The second conveyor component 31 can be connected to the second reaction container 50 through the needle assembly 20, which enables the delivery and dispensing of the synthesized drug in the second reaction container.

[0254] By controlling the movement of the multi-port component 311 to connect or disconnect it from the dispensing container 34, the device meets its operational requirements. When venting is required, the multi-port component 311 separates from the dispensing container 34. When dispensing the synthesized drug, the multi-port component 311 connects to the dispensing container 34, allowing the synthesized drug to be conveyed by the second conveyor component 31 and the multi-port component 311 into the dispensing container 34 for storage. Furthermore, by precisely controlling the insertion and withdrawal of the needle assembly 20 from the second reaction container 50, the timing of drug delivery can be precisely controlled, ensuring the drug reaches its target location smoothly. Thus, the cooperation of the second conveyor component 31, the multi-port component 311, the needle assembly 20, and the dispensing container 34 enables automatic drug dispensing, reduces drug waste and losses during delivery, and improves the efficiency and safety of drug dispensing.

[0255] According to some embodiments of the present invention, the method further includes: When the first reactant flows from the first reaction vessel 16 into the second reaction vessel, the control multi-port component 311 is separated from the dispensing container 34. When the synthesized drug flows into the dispensing container 34, the control multi-port 311 is connected to the dispensing container 34.

[0256] When the first reactant flows from the first reaction container 16 into the second reaction container, the multi-port component 311 is controlled to separate from the dispensing container 34 so that the gas in the second reaction container 50 is discharged through the pin assembly 20, the second conveying component 31, and the multi-port component 311, thereby balancing the gas pressure inside and outside the second reaction container and reducing the risk of the second reaction container rupturing or losing its seal.

[0257] When the synthesized drug flows into the dispensing container, the multi-port 311 is connected to the dispensing container 34 to ensure that the synthesized drug flows smoothly into the dispensing container, thereby realizing automatic drug dispensing.

[0258] According to some embodiments of the present invention, the drug dispensing device 30 further includes: a third drive module 15, which is connected to the multi-channel component 311; The method also includes: The third drive module 15 is activated, and the third drive module 15 drives the multi-channel component 311 to move so that the multi-channel component 311 can be connected to or separated from the dispensing container 34.

[0259] The third drive module 15 may include a lead screw module, a slide rail, and other mechanisms. The third drive module 15 and the multi-channel component 311 can be connected by sliding or threaded connections. Controlling the start of the third drive module 15 drives the movement of the multi-channel component 311, allowing it to connect or disconnect from the dispensing container 34. This enables venting of the second reaction vessel when the multi-channel component 311 is disconnected from the dispensing container 34, and drug dispensing when the multi-channel component 311 is connected to the dispensing container 34. This improves the automation level of the drug production system, reduces contact between medical personnel and drugs, and significantly reduces the radiation hazards of radiopharmaceuticals to medical personnel.

[0260] According to some embodiments of the present invention, the drug dispensing device 30 further includes: a mounting base 312, the mounting base 312 being fixed to the third drive module 15, and a multi-pass component 311 being fixed to the mounting base 312; The method also includes: The third drive module 15 is started, and the third drive module 15 drives the mounting base 312 to move the multi-channel component 311.

[0261] The mounting base 312 is fixed to the third drive module 15, and the multi-channel component 311 is fixed to the mounting base 312. The third drive module 15 is controlled to start, and the mounting base 312 is driven by the third drive module 15 to move the multi-channel component 311. When the third drive module 15 moves, the mounting base 312 and the third drive module 15 move synchronously to drive the multi-channel component 311 to move synchronously, so as to realize the connection or separation of the multi-channel component 311 from the dispensing container 34. Thus, the second reaction container 50 can be vented when the multi-channel component 311 is separated from the dispensing container 34, and the drug can be dispensed when the multi-channel component 311 is connected to the dispensing container 34. This improves the automation level of the drug production system, reduces the contact between medical personnel and drugs, and greatly reduces the radiation hazards of radiopharmaceuticals to medical personnel.

[0262] According to some embodiments of the present invention, the second conveying member 31 includes a second conduit 313, the second driving mechanism 32 includes a second peristaltic pump 322, and the second conduit 313 connects the pin assembly 20 and the dispensing container 34. The method also includes: At least a portion of the second conduit 313 is installed within the second extrusion groove 321 of the second peristaltic pump 322.

[0263] The second conduit 313 connects the needle assembly 20 and the dispensing container 34. The needle assembly 20 is connected to the second reaction container 50, enabling the delivery of the synthesized drug within the second reaction container 50. At least a portion of the second conduit 313 is installed within the second extrusion groove 321 of the second peristaltic pump 322, allowing the second peristaltic pump 322 to deliver the synthesized drug by extruding the second conduit 313. The delivery rate of the synthesized drug can be precisely controlled by adjusting the rotational speed of the second peristaltic pump 322, ensuring that the synthesized drug is delivered from the second reaction container 50 to the dispensing container 34 at a predetermined flow rate and speed, thus guaranteeing quantitative delivery and dispensing of the synthesized drug. The working principle of the second peristaltic pump 322 determines the continuity and stability of its delivery process. Because the second conduit 313 is fixed within the second extrusion groove 321, the extrusion action of the pump head roller on the second conduit 313 is uniform and stable, thereby avoiding fluctuations and instability in the delivery process of the synthesized drug, and thus improving the stability and reliability of drug synthesis in the drug production system.

[0264] According to some embodiments of the present invention, the drug dispensing device 30 further includes: a second shielding radiation protection structure 33; The method also includes: The dispensing container 34 is placed inside the second shielding radiation protection structure 33.

[0265] The second radiation shielding structure 33 can be made of shielding materials such as iron, copper, or tungsten. When the dispensing container 34 contains radioactive drugs, the second radiation shielding structure 33 is used to place the dispensing container 34, effectively shielding it and blocking and absorbing radiation from the radioactive drugs within, providing more comprehensive protection for medical personnel. When the drugs in the dispensing container 34 are not radioactive, the second radiation shielding structure 33 also provides stable support and protection for the dispensing container 34, preventing damage during the storage of synthetic drugs. It also protects the dispensing container 34 from external physical impacts and chemical corrosion to a certain extent, thus ensuring the technical efficacy and safety of the drugs. Furthermore, by setting up a second shielding and radiation protection structure 33 to provide targeted protection for the dispensing container 34, the overall protective material requirements for the external environment of the drug production system 100 can be reduced. In the application scenario, this is specifically manifested as the isolation cabinet 200, which in turn reduces the overall weight of the drug production system 100 and the external isolation cabinet 200, thereby reducing the load-bearing capacity of the floor where the drug production system 100 and the external isolation cabinet 200 are located.

[0266] According to some embodiments of the present invention, the second shielding and radiation protection structure 33 is formed with a shielding groove that is open at one end; The method also includes: Place the dispensing container 34 inside the shielding tank.

[0267] The dispensing container 34 is placed in the shielding groove, which allows the dispensing container 34 to be easily put in and taken out without complicated operations or additional tools. Furthermore, the shielding groove with one open end is also suitable for dispensing containers of various types and specifications, and has high versatility and adaptability.

[0268] According to some embodiments of the present invention, the drug production system 100 further includes: a first activity detection device 51, which is adjacent to the dispensing container 34; The method also includes: The first activity detection device 51 is activated, and the first activity detection device 51 detects the drug activity in the dispensing container 34.

[0269] The first activity detection device 51 can be an activity probe, activity sensor, or other similar device. Controlling the activation of the first activity detection device 51 allows it to detect the drug activity within the dispensing container 34, providing a monitoring value for the drug's activity. This feedback of drug information within the dispensing container 34 (such as activity, volume, and mass, where volume and mass can be calculated using formulas) provides effective data support for drug dispensing, improving the accuracy and reliability of the dispensing process. When the drug activity within the dispensing container 34 reaches a preset value, the second drive mechanism 32 stops driving the drug in the second reaction container 50 to flow into the dispensing container 34 along the second conveyor 31, and disconnects the second reaction container 50 from the dispensing container 34. Specifically, the multi-port 311 is disconnected from the dispensing container 34 to achieve measured drug dispensing.

[0270] Furthermore, the volume parameters of the drug can be preset for the second drive mechanism 32. The second drive mechanism 32 can also flow the drug in the second reaction container 50 into the dispensing container 34 along the second conveyor 31 according to the preset drug volume parameters. When the volume of the drug in the dispensing container 34 reaches the preset drug volume parameters, the second drive mechanism 32 stops working to disconnect the second reaction container 50 from the dispensing container 34. Specifically, the multi-port 311 is disconnected from the dispensing container 34 to achieve quantitative dispensing of the drug.

[0271] The first activity detection device 51 is adjacent to the dispensing container 34, which facilitates the first activity detection device 51 to monitor the drug in the dispensing container 34, helps to detect changes in drug activity in a timely manner, and thus take necessary measures to ensure the quality and safety of the drug.

[0272] According to some embodiments of the present invention, the pin assembly 20 includes: a first pin 21 and a second pin 22, wherein the length of the first pin 21 is greater than the length of the second pin 22. The method also includes: During the synthesis process, the first insertion pin 21 is controlled to be inserted into the second reaction vessel 50 and kept apart from the solvent in the second reaction vessel 50, and the gas in the second reaction vessel 50 is discharged through the first insertion pin 21. During the dispensing process, the first needle 21 and the second needle 22 are both inserted into the second reaction container 50, and the first needle 21 is inserted into the synthesized drug. The synthesized drug is discharged through the first needle 21, and the second needle 22 is kept apart from the synthesized drug. Gas outside the second reaction container 50 enters the second reaction container 50 through the second needle 22.

[0273] During the synthesis process, the first insertion pin 21 is inserted into the second reaction vessel 50 and kept separate from the solvent in the second reaction vessel 50 during the synthesis process, so that the gas in the second reaction vessel 50 can be discharged through the first insertion pin 21, ensuring the pressure balance inside and outside the second reaction vessel 50. Specifically, the first insertion pin 21 is connected to the second conveying member 31, and the second conveying member 31 is connected to the multi-port member 311. When venting is carried out through the first insertion pin 21, the multi-port member 311 is separated from the dispensing container 34, so that the gas in the second reaction vessel 50 can be discharged through the first insertion pin 21, the second conveying member 31, and the multi-port member 311.

[0274] During the dispensing process, both the first needle 21 and the second needle 22 are inserted into the second reaction container 50, with the first needle 21 inserted into the synthesized drug so that the synthesized drug can be discharged through the first needle 21. The second needle 22 remains separated from the synthesized drug during the dispensing process so that gas outside the second reaction container 50 can enter the second reaction container 50 through the second needle 22, ensuring pressure balance inside and outside the second reaction container 50. Specifically, the first needle 21 is connected to the second conveyor 31, and the second conveyor 31 is connected to the multi-port 311. When the first needle 21 is inserted into the synthesized drug, the multi-port 311 is connected to the dispensing container 34 so that the synthesized drug in the second reaction container 50 is dispensed into the dispensing container 34 through the first needle 21, the second conveyor 31, and the multi-port 311, thus realizing the dispensing of the synthesized drug.

[0275] According to some embodiments of the present invention, the method further includes: During the synthesis process, the first driving mechanism 12 and the second driving mechanism 32 are both controlled to work and the multi-port component 311 is controlled to separate from the dispensing container 34, so that when the first reactant in the first reaction container 16 flows into the second reaction container 50, the gas in the second reaction container 50 is discharged through the pin assembly 20 and the multi-port component 311.

[0276] During the synthesis process, the first driving mechanism 12 and the second driving mechanism 32 are both operating and the multi-port 311 is separated from the dispensing container 34. This allows the first reactant in the first reaction container 16 to flow into the second reaction container 50, while the gas in the second reaction container 50 is discharged through the needle assembly 20 and the multi-port 311. This balances the gas pressure inside and outside the second reaction container, reduces the risk of the second reaction container rupture or reduced sealing, improves the automation level of the drug production system, reduces the contact between medical personnel and drugs, and greatly reduces the radiation hazards of radiopharmaceuticals to medical personnel.

[0277] According to some embodiments of the present invention, the drug dispensing device 30 further includes a multi-port member 311, which is movable to communicate with or separate from the dispensing container 34. Before controlling the movement of the second reaction vessel 50 relative to the pin assembly 20, the method further includes: After connecting the first conveyor 11 to the first reaction container 16 and the second reaction container 50, at least a portion of the first conveyor 11 is installed in the first drive mechanism 12. After connecting the second conveyor 31 to the pin assembly 20 and the multi-port member 311, at least a portion of the second conveyor 31 is installed in the second drive mechanism 32. Control the movement of the multi-port component 311 to separate it from the dispensing container 34.

[0278] Wherein, after the first conveyor 11 is connected to the first reaction container 16 and the second reaction container 50, at least a portion of the first conveyor 11 is installed in the first drive mechanism 12 so that the first reactant in the first reaction container 16 can flow into the second reaction container 50 through the first conveyor 11 to achieve drug synthesis.

[0279] After connecting the second conveyor 31 to the pin assembly 20 and the multi-port 311, at least a portion of the second conveyor 31 is installed in the second drive mechanism 32. The movement of the multi-port 311 is controlled to separate it from the dispensing container 34, allowing the gas in the second reaction container 50 to be discharged through the pin assembly 20, the second conveyor 31, and the multi-port 311 to balance the gas pressure inside and outside the second reaction container 50. This ensures that the first reactant in the first reaction container 16 can flow smoothly into the second reaction container 50 through the first conveyor 11, reducing the risk of the second reaction container 50 rupture or reduced sealing, improving the automation level of the drug production system 100, reducing the contact between medical personnel and drugs, and greatly reducing the radiation hazards of radiopharmaceuticals to medical personnel.

[0280] According to some embodiments of the present invention, the drug synthesis apparatus 10 further includes: a heating device 24; the method further includes: After the first conveyor 11 and the second conveyor 31 are installed, the heating device 24 is activated to preheat the components. After the first conveyor 11 and the second conveyor 31 are installed, the synthesis and packaging of drugs can be carried out. When the synthesized drug in the second reaction container 50 needs to be heated, the heating device 24 can be controlled to preheat in advance, so that the second reaction container 50 can be heated immediately, shortening the drug synthesis time, improving the drug heating efficiency of the drug production system, and shortening the preheating waiting time.

[0281] The drug synthesis method according to embodiments of the present invention is applied to a drug production system, such as... Figure 1-9 As shown, the method includes: S201, the control pin assembly 20 is activated so that the pin assembly 20 is inserted into the second reaction container 50; wherein, the second reaction container 50 stores the second reactant; S202, the first drive mechanism 12 of the drug synthesis apparatus 10 is activated so that the first drive mechanism 12 cooperates with the first conveyor 11 to drive the first reactant to flow into the second reaction container along the first conveyor 11 for synthesis; wherein, the first reactant is stored in the first reaction container 16, and the first conveyor 11 connects the first reaction container 16 and the second reaction container 50. In this scenario, when the first driving mechanism 12 cooperates with the first conveying member 11 to drive the first reactant into the second reaction container 50 along the first conveying member 11, the needle assembly 20 remains separated from the solvent in the second reaction container 50, so that the gas in the second reaction container 50 can be discharged through the needle assembly 20. This is used to balance the gas pressure inside and outside the second reaction container, reduce the risk of the second reaction container rupture or reduced sealing, and also ensure that the first reactant is smoothly delivered into the second reaction container to be mixed with the second reactant and synthesize the drug.

[0282] According to some embodiments of the present invention, the drug production system 100 further includes: a first drive module 13; The method also includes: The first drive module 13 is activated to drive the second reaction vessel 50 to move so that the first reactant and the second reactant in the second reaction vessel 50 are mixed.

[0283] The first drive module 13 is activated to control the first drive module 13. The first drive module 13 may include a motor, a lead screw module, a gripper 17 and other structures. The first drive module 13 can drive the second reaction container 50 to move (such as rotation, shaking, translation and other forms of movement) to promote the full mixing of the first reactant and the second reactant in the second reaction container 50, thereby enabling the automatic synthesis of the drug.

[0284] According to some embodiments of the present invention, controlling the first drive module 13 to start so that the first drive module 13 drives the second reaction vessel 50 to move so that the first reactant and the second reactant in the second reaction vessel 50 are mixed, including: The first drive module 13 is activated to drive the second reaction container 50 to reciprocate along a first direction so that the first reactant and the second reactant in the second reaction container 50 are mixed; wherein, the first direction is the height direction of the drug production system.

[0285] Specifically, the first drive module 13 is activated, driving the second reaction container 50 to reciprocate along a first direction via the gripper 17. This ensures thorough mixing of the drug within the second reaction container 50. The continuous agitation of the first and second reactants within the second reaction container 50 in the first direction facilitates mixing. This automated mixing process is more efficient than manual operation, enabling the mixing of large quantities of drug in a short time, thus improving production efficiency. Furthermore, the uniformly mixed drug exhibits more stable efficacy during subsequent dispensing and use, contributing to improved final product quality.

[0286] It can be noted that the first direction can be any direction of the drug production system 100, such as the height direction or the lateral direction, as long as the drug can be thoroughly shaken. As a specific embodiment of the present invention, the first direction is the height direction of the drug production system 100. Setting the first direction as the height direction helps to optimize the spatial layout of the drug production system. By rationally designing the structure of the drug production system, the internal space resources of the drug production system can be fully utilized, reducing the floor area and volume of the equipment.

[0287] According to some embodiments of the present invention, the method further includes: The second reaction vessel 50 and the pin assembly 20 are positioned opposite each other along the first direction.

[0288] In this design, the second reaction container 50 and the needle assembly 20 are positioned relative to each other along a first direction. The first drive module 13, specifically the gripper 17, drives the second reaction container 50 to move along the first direction, allowing the needle assembly 20 to be precisely inserted into the second reaction container 50. This linear motion path eliminates accumulated errors from multi-axis linkage, ensuring the needle assembly can be accurately inserted into designated positions within the second reaction container (such as sealing membranes or liquid inlets). This reduces the risk of collision between the needle assembly and surrounding structures of the second reaction container, improving equipment safety. Furthermore, the relative positioning minimizes the movement path of the second reaction container, reducing unnecessary displacement time and shortening the time required for drug synthesis and dispensing.

[0289] According to some embodiments of the present invention, the drug synthesis apparatus 10 further includes a heating device 24; The method also includes: The heating device 24 is activated to heat the second reaction vessel 50.

[0290] The heating device 24 can be configured as an electric heating mantle, an electric furnace, an electric heating plate, an electric steam generator, etc., without specific limitations. Controlling the start of the heating device 24 allows it to heat the second reaction vessel 50, thereby heating the mixture of the first and second reactants within the second reaction vessel 50. This provides strong support for the heat treatment of the synthesized drug, fulfilling the requirements of the drug synthesis process and ensuring the quality and efficacy of the drug.

[0291] According to some embodiments of the present invention, the drug production system 100 further includes: a support 40, the support 40 having a placement space 41 with an open end; The method also includes: The second reaction container 50 is placed in the placement space 41; wherein, when the second reaction container 50 is placed in the placement space 41, the neck and mouth of the second reaction container 50 are exposed from the open end of the placement space 41.

[0292] The first drive module 13 can be activated to drive the second reaction container 50 to move into the placement space 41, so that the second reaction container 50 is stably located on the support 40. This avoids the need for manual placement of the second reaction container and reduces the radioactive hazards to operators when the second reaction container contains radioactive reactants.

[0293] With the second reaction container 50 placed within the placement space 41, its neck and mouth are exposed from the open end of the space. This open end design eliminates the need for additional steps such as opening the hatch or flipping the lid when moving the second reaction container 50. The exposed neck and mouth of the second reaction container 50 facilitate smooth gripping of the second reaction container 50 by the first drive module 13, specifically the gripper 17. The open end also provides an unobstructed gripping path for the first drive module 13, enabling automatic transfer of the second reaction container 50 and improving the automation level of the drug production system 100. The exposed neck and mouth of the second reaction container 50 also facilitate the insertion and mating of the needle assembly 20 with the second reaction container 50, reducing operational errors caused by tilting or obstruction of the second reaction container 50.

[0294] According to some embodiments of the present invention, the drug synthesis apparatus 10 further includes a heating device 24, which is disposed within the support base 40; The method also includes: The heating device 24 is activated to heat the second reaction vessel 50.

[0295] The heating device 24 can be housed within the placement space 41 of the support base 40, allowing it to directly contact the second reaction vessel 50. Heating the second reaction vessel 50 via the heating device 24 reduces air gaps in the heat transfer path, helping to minimize heat loss, improve heating efficiency, and reduce the procurement, assembly, and debugging of independent heating components, thus lowering costs. Furthermore, the heating device 24 and the support base 40 can be integrated seamlessly, resulting in a compact structure that eliminates the need for additional heating plates or hot air modules. The open placement space 41 also maintains the ease of loading and unloading the second reaction vessel 50.

[0296] The heating device 24 is activated to heat the second reaction vessel 50, which reduces the air gap in the heat transfer path, helps to reduce heat loss, improves the heating efficiency of the second reaction vessel 50, and accelerates the synthesis speed of the drug.

[0297] According to some embodiments of the present invention, the method further includes: The support base 40, the second reaction container 50 and the needle assembly 20 are arranged along a first direction, and the second reaction container 50 is disposed between the support base 40 and the needle assembly 20; wherein, the first direction is the height direction of the drug production system 100.

[0298] The support base 40 is used for placing and fixing the second reaction container 50, and the pin assembly 20 is located above the second reaction container 50. In this embodiment, the support base 40 and the pin assembly 20 are fixedly arranged. Specifically, the support base 40 is fixedly arranged on the base (not shown), and the pin assembly 20 is fixedly arranged on the mounting mechanism (not shown). The second reaction container 50 can move between the support base 40 and the pin assembly 20 by the drive of the first drive module 13, so that the second reaction container 50 can move and be placed in the placement space 41 of the support base 40, and also so that the second reaction container 50 can move to the pin assembly 20 for insertion and engagement. The support base 40, the second reaction container 50, and the needle assembly 20 are arranged along the first direction, with the second reaction container 50 located between the support base 40 and the needle assembly 20. This arrangement conforms to the reasonable movement of the second reaction container 50, avoids multi-directional movement of the second reaction container 50, and makes the support base 40, the second reaction container 50, and the needle assembly 20 more compact. This helps to optimize the spatial layout of the drug production system 100, fully utilize the internal space resources of the drug production system 100, and reduce the footprint and volume of the equipment.

[0299] According to some embodiments of the present invention, the drug synthesis apparatus 10 further includes a heat dissipation device 25; The method also includes: The heat dissipation device 25 is activated to cool the second reaction vessel 50.

[0300] The heat dissipation device 25 can be constructed as a fan, heat sink, liquid cooling device, etc., and is not specifically limited here, as long as the heat dissipation device 25 can be used to cool the second reaction vessel 50. The heat dissipation device 25 acts directly on the second reaction vessel 50, and can effectively remove the heat from the second reaction vessel 50 and the mixed reactants inside, thereby achieving a cooling effect.

[0301] According to some embodiments of the present invention, the drug production system 100 further includes: a first drive module 13, and a heat dissipation device 25 fixedly disposed on the first drive module 13; The method also includes: The first drive module 13 is activated so that it drives the second reaction vessel 50 to move.

[0302] The heat dissipation device 25 acts directly on the second reaction container 50, effectively removing heat from the second reaction container 50 and its internal mixed reactants, thus achieving a cooling effect. The heat dissipation device 25 is fixed to the first drive module 13. After the first drive module 13 drives the second reaction container 50 to move away from the placement space 41, the heat dissipation device 25 cools the second reaction container 50. The heat dissipation device 25 is correspondingly positioned to the second reaction container 50, ensuring smooth cooling. Furthermore, while the first drive module 13 drives the second reaction container 50, the heat dissipation device 25 simultaneously and smoothly cools the second reaction container 50, providing strong support for the cooling process of the drug and ensuring its quality and efficacy.

[0303] According to some embodiments of the present invention, the method further includes: Along a first direction, at least a portion of the heat dissipation device 25 and the second reaction vessel 50 are disposed on the same side of the first drive module 13; wherein, the first direction is the height direction of the drug production system 100.

[0304] Along the first direction, at least a portion of the heat dissipation device 25 and the second reaction container 50 are located on the same side of the first drive module 13. Both the heat dissipation device 25 and the second reaction container 50 may have one-half or two-thirds of their portions located on the same side of the first drive module 13. However, the present invention is not limited to this. The heat dissipation device 25 and the second reaction container 50 may also have other proportions of their portions located on the same side of the first drive module 13, as long as at least a portion of the heat dissipation device 25 and the second reaction container 50 are located on the same side of the first drive module 13.

[0305] As an example of the present invention, along the first direction, the heat dissipation device 25 and the second reaction container 50 are both located below the first drive module 13, and the heat dissipation device 25 can extend downward along the first direction so that the heat dissipation device 25 is correspondingly arranged with the second reaction container 50, thereby enabling the heat dissipation device 25 to fully cool the second reaction container 50, providing strong support for the cooling treatment of the drug, and ensuring the quality and efficacy of the drug.

[0306] According to some embodiments of the present invention, the heat dissipation device 25 has an air outlet 251 that extends along the depth direction of the second reaction vessel 50. The method also includes: The heat dissipation device 25 blows air into the second reaction vessel 50 through the air outlet 251.

[0307] The heat dissipation device 25 has an air outlet 251 that can extend downward in the first direction, so that the shape of the air outlet 251 corresponds to the shape of the second reaction container 50. The heat dissipation device 25 blows air to the second reaction container 50 through the air outlet 251, which can fully cool the second reaction container 50, improve the cooling efficiency of the heat dissipation device 25 on the second reaction container 50, provide strong support for the cooling treatment of the drug, and ensure the quality and efficacy of the drug.

[0308] The air vent 251 extends along the depth direction of the second reaction container 50, so that the shape of the air vent 251 corresponds to the shape of the second reaction container 50. The heat dissipation device 25 blows air to the second reaction container 50 through the air vent 251, which can fully cool the second reaction container 50, improve the cooling efficiency of the heat dissipation device 25 on the second reaction container 50, and further provide strong support for the cooling treatment of the drug, ensuring the quality and efficacy of the drug.

[0309] According to some embodiments of the present invention, the drug synthesis apparatus 10 further includes: a first shielding and radiation protection structure 23, wherein the first shielding and radiation protection structure 23 is configured as an arc-shaped structure; The method also includes: The first shielding radiation protection structure 23 is arranged around the second reaction container 50.

[0310] The first radiation shielding structure 23 can be made of shielding materials such as iron, copper, tungsten, and lead. It can be positioned around the second reaction container 50. When the second reaction container 50 contains radioactive reactants, it acts as a shield, effectively shielding the radiation generated by the radioactive material or agent, thus protecting the surrounding environment and the safety of operators. Furthermore, by specifically protecting the second reaction container 50 with the first radiation shielding structure 23, the overall protective material requirements for the external environment of the drug production system 100 can be reduced. In this application scenario, this is specifically manifested in the isolation cabinet 200, thereby reducing the overall weight of the drug production system 100 and the external isolation cabinet 200, and consequently reducing the load-bearing capacity of the floor where they are located.

[0311] According to some embodiments of the present invention, the first shielding radiation protection structure 23 includes at least one shielding part 231; The method also includes: The control shield 231 is closer to the operator than the second reaction vessel 50.

[0312] The first radiation shielding structure 23 may include one, two, three, or other shielding parts, but the invention is not limited to this; the first radiation shielding structure 23 may also include other numbers of shielding parts, as long as it includes at least one shielding part. The control shielding part 231 is closer to the operator than the second reaction container 50, thus isolating the second reaction container 50 from the operator. When the reactant in the second reaction container 50 is radioactive, isolating the second reaction container 50 from the operator through the shielding part 231 directly reduces the radiation flux reaching the operator, greatly reducing the radioactive hazard to the operator from the radiopharmaceutical.

[0313] According to some embodiments of the present invention, the drug synthesis apparatus 10 further includes: a second drive module 14, which is connected to the first shielding and radiation protection structure 23; The method also includes: The second drive module 14 is activated to drive the first shielding and radiation protection structure 23 to move, so that the first shielding and radiation protection structure 23 remains around the second reaction container 50.

[0314] The second drive module 14 may include a lead screw module, a slide rail, and other mechanisms. The second drive module 14 and the first shielding and radiation protection structure 23 can be connected by sliding or threaded connections. By controlling the activation of the second drive module 14, the first shielding and radiation protection structure 23 is driven to move, keeping it surrounding the second reaction container 50. When the second reaction container 50 contains radioactive reactants, the second drive module 14 drives the first shielding and radiation protection structure 23 to move along with the second reaction container 50, ensuring that the first shielding and radiation protection structure 23 always surrounds the second reaction container 50, continuously shielding it and effectively blocking and absorbing radiation from the radioactive reactants within the second reaction container 50, thus providing more comprehensive protection for medical personnel.

[0315] According to some embodiments of the present invention, the method further includes: The second drive module 14 is activated to make the first shielding radiation protection structure 23 move in the same direction as the second reaction container 50.

[0316] Specifically, the second drive module 14 is activated to drive the first shielding radiation protection structure 23 to move in the same direction as the second reaction container 50. When the second reaction container 50 is displaced due to demand, the second drive module 14 can drive the first shielding radiation protection structure 23 to move at the same speed and direction, ensuring that the first shielding radiation protection structure 23 always covers the second reaction container 50, avoiding protective gaps caused by the movement of the second reaction container 50, thereby reducing the radiation hazard of radiopharmaceuticals to operators.

[0317] According to some embodiments of the present invention, the method further includes: The second drive module 14 is activated so that the first shielding radiation protection structure 23 moves synchronously with the second reaction container 50.

[0318] The second drive module 14 is activated, and the first shielding radiation protection structure 23 is driven to move synchronously with the second reaction container 50. This ensures that the first shielding radiation protection structure always covers the second reaction container, eliminates the protective gap caused by the movement of the second reaction container, and further reduces the radioactive hazards of radiopharmaceuticals to operators.

[0319] According to some embodiments of the present invention, the first conveying member 11 includes a first pipeline 111, the first driving mechanism 12 includes a first peristaltic pump 121, and the first pipeline 111 connects the first reaction vessel 16 and the second reaction vessel 50. The method also includes: At least a portion of the first conduit 111 is installed within the first extrusion groove 214 of the first peristaltic pump 121.

[0320] The first pipeline 111 is used to connect the first reaction container 16 and the second reaction container 50, thereby enabling the delivery of the first reactant. At least a portion of the first pipeline 111 is installed in the first extrusion groove 214 of the first peristaltic pump 121. The first reactant is delivered by extruding the first pipeline 111 through the first peristaltic pump 121. The delivery amount of the first reactant can be precisely controlled by adjusting the rotation speed of the first peristaltic pump 121, so that the first reactant can be delivered from the first reaction container to the second reaction container at a predetermined flow rate and speed, ensuring the quantitative delivery of the drug.

[0321] The working principle of the first peristaltic pump 121 determines the continuity and stability of its delivery process. Since the first pipeline 111 is fixed in the first extrusion groove 214, the extrusion action of the pump head roller on the first pipeline is uniform and stable, thereby avoiding fluctuations and instability of the first reactant during delivery. It also avoids delivering the first reactant through a syringe each time, reducing syringe consumables and preventing the first reactant from remaining in the syringe and contaminating the subsequently synthesized drug. By pushing the liquid in the first pipeline forward by the first peristaltic pump 121, it will not touch the liquid in the first pipeline, avoiding contamination and residue, thereby improving the stability and reliability of drug synthesis in the drug production system.

[0322] According to some embodiments of the present invention, the first reaction vessel 16 further includes: a nuclide generator 215 and a reagent preparation device, the nuclide generator 215 having a generator inlet 212 and a generator outlet 213. The method also includes: Connect the generator inlet 212 to the reagent preparation, and connect the generator outlet 213 and the second reaction vessel 50 through the first pipeline 111.

[0323] The nuclide generator 215 has a generator inlet 212 and a generator outlet 213. The generator inlet 212 is used to connect with the reagent preparation, and the generator outlet 213 is connected to the second reaction vessel 50 through the first pipeline 111. The reagent preparation (e.g., 5 ml of hydrochloric acid) can be delivered into the nuclide generator 215 through the generator inlet 212 to achieve rinsing of the nuclide generator 215. The first pipeline 111 is used to connect the generator outlet 213 and the second reaction vessel 50, and the first reactant (e.g., radioactive isotope) that has been rinsed off can be delivered into the second reaction vessel 50 through the generator outlet 213 and the first pipeline 111.

[0324] According to some embodiments of the present invention, the method further includes: In the flow direction of the first reactant within the first conveyor 11, the first peristaltic pump 121 is positioned downstream of the nuclide generator 215 and upstream of the second reaction vessel 50.

[0325] In the flow direction of the first reactant within the first conveying member 11, the first peristaltic pump 121 is located downstream of the nuclide generator 215 and upstream of the second reaction vessel 50, conforming to the flow path of the first reactant. This allows the first peristaltic pump to smoothly deliver the first reactant (e.g., a radioactive isotope) leached from the nuclide generator through the generator outlet 213 and the first pipeline 111 to the second reaction vessel 50, and enables continuous delivery of the first reactant.

[0326] An electronic device according to an embodiment of the present invention includes: a processor and a memory, wherein the memory stores a program or instructions that can run on the processor, and when the program or instructions are executed by the processor, the steps of the above-described drug manufacturing method are implemented.

[0327] The electronic device may include: a processor, memory, input / output interfaces, communication interfaces, and a bus. The processor, memory, input / output interfaces, and communication interfaces communicate with each other within the device via the bus.

[0328] The processor can be implemented using a general-purpose CPU (Central Processing Unit), microprocessor, application-specific integrated circuit (ASIC), or one or more integrated circuits, and is used to execute relevant programs or instructions to implement the technical solutions provided in the embodiments of this specification.

[0329] The memory can be implemented in the form of ROM (Read Only Memory), RAM (Random Access Memory), static storage devices, dynamic storage devices, etc. The memory can store the operating system and other applications. When the technical solutions provided in the embodiments of this specification are implemented through software or firmware, the relevant program code is stored in the memory and called and executed by the processor.

[0330] Input / output interfaces are used to connect input / output modules to enable information input and output. Input / output modules can be configured as components within electronic devices or connected externally to provide corresponding functions. Input devices can include keyboards, mice, touchscreens, microphones, various sensors, etc., while output devices can include displays, speakers, vibrators, indicator lights, etc.

[0331] The communication interface is used to connect the communication module to enable communication and interaction between this electronic device and other devices. The communication module can communicate via wired means (such as USB, Ethernet cable, etc.) or wireless means (such as mobile network, WIFI, Bluetooth, etc.).

[0332] A bus is a pathway that transmits information between various components of a device, such as processors, memory, input / output interfaces, and communication interfaces.

[0333] It should be noted that although the above-described electronic device only includes a processor, memory, input / output interface, communication interface, and bus, in actual implementation, the electronic device may also include other components necessary for normal operation.

[0334] The electronic devices described in the above embodiments are used to implement the corresponding drug production methods in any of the foregoing embodiments and have the beneficial effects of the corresponding drug production method embodiments, which will not be repeated here.

[0335] An electronic device according to an embodiment of the present invention includes: a processor and a memory, wherein the memory stores a program or instructions that can run on the processor, and when the program or instructions are executed by the processor, the steps of the above-described drug synthesis method are implemented.

[0336] The electronic device may include: a processor, memory, input / output interfaces, communication interfaces, and a bus. The processor, memory, input / output interfaces, and communication interfaces communicate with each other within the device via the bus.

[0337] The processor can be implemented using a general-purpose CPU (Central Processing Unit), microprocessor, application-specific integrated circuit (ASIC), or one or more integrated circuits, and is used to execute relevant programs or instructions to implement the technical solutions provided in the embodiments of this specification.

[0338] The memory can be implemented in the form of ROM (Read Only Memory), RAM (Random Access Memory), static storage devices, dynamic storage devices, etc. The memory can store the operating system and other applications. When the technical solutions provided in the embodiments of this specification are implemented through software or firmware, the relevant program code is stored in the memory and called and executed by the processor.

[0339] Input / output interfaces are used to connect input / output modules to enable information input and output. Input / output modules can be configured as components within electronic devices or connected externally to provide corresponding functions. Input devices can include keyboards, mice, touchscreens, microphones, various sensors, etc., while output devices can include displays, speakers, vibrators, indicator lights, etc.

[0340] The communication interface is used to connect the communication module to enable communication and interaction between this electronic device and other devices. The communication module can communicate via wired means (such as USB, Ethernet cable, etc.) or wireless means (such as mobile network, WIFI, Bluetooth, etc.).

[0341] A bus is a pathway that transmits information between various components of a device, such as processors, memory, input / output interfaces, and communication interfaces.

[0342] It should be noted that although the above-described electronic device only includes a processor, memory, input / output interface, communication interface, and bus, in actual implementation, the electronic device may also include other components necessary for normal operation.

[0343] The electronic devices described in the above embodiments are used to implement the corresponding drug synthesis methods in any of the foregoing embodiments, and have the beneficial effects of the corresponding drug synthesis method embodiments, which will not be repeated here.

[0344] According to an embodiment of the present invention, a computer-readable storage medium stores a program or instructions that, when executed by a processor, implement the steps of the above-described drug manufacturing method.

[0345] The computer-readable storage medium can be any available medium or data storage device that a computer can access, including but not limited to magnetic storage (such as floppy disks, hard disks, magnetic tapes, magneto-optical disks (MOs), etc.), optical storage (such as CDs, DVDs, BDs, HVDs, etc.), and semiconductor storage (such as ROMs, EPROMs, EEPROMs, non-volatile memory (NAND flash), solid-state drives (SSDs)).

[0346] The computer instructions stored in the storage medium of the above embodiments are used to cause the computer to execute the corresponding drug production method in any of the foregoing embodiments, and have the beneficial effects of the corresponding drug production method embodiments, which will not be repeated here.

[0347] According to an embodiment of the present invention, a computer-readable storage medium stores a program or instructions that, when executed by a processor, implement the steps of the above-described drug synthesis method.

[0348] The computer-readable storage medium can be any available medium or data storage device that a computer can access, including but not limited to magnetic storage (such as floppy disks, hard disks, magnetic tapes, magneto-optical disks (MOs), etc.), optical storage (such as CDs, DVDs, BDs, HVDs, etc.), and semiconductor storage (such as ROMs, EPROMs, EEPROMs, non-volatile memory (NAND flash), solid-state drives (SSDs)).

[0349] The computer instructions stored in the storage medium of the above embodiments are used to cause the computer to execute the corresponding drug synthesis method in any of the foregoing embodiments, and have the beneficial effects of the corresponding drug synthesis method embodiments, which will not be repeated here.

[0350] In the description of this specification, the references to terms such as "one embodiment," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0351] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. A drug production system, characterized in that, include: A first reaction container and a second reaction container, wherein the first reaction container is used to store a first reactant and the second reaction container is used to store a second reactant; A first conveyor, the first conveyor connecting the first reaction vessel and the second reaction vessel; A drug synthesis apparatus, the drug synthesis apparatus including a first driving mechanism, the first driving mechanism and a first conveying member cooperating to drive the first reactant to flow along the first conveying member into a second reaction vessel for synthesis; Dispensing containers are used to store the synthesized drug. The second delivery unit is used to deliver the synthesized drug; A drug dispensing device, the drug dispensing device including a second driving mechanism, the second driving mechanism and a second conveying member cooperate to drive the synthesized drug to flow into the dispensing container along the second conveying member; A pin assembly, wherein the second delivery member connects the pin assembly and the dispensing container, the pin assembly being adapted to be inserted into or removed from the second reaction container, and wherein the pin assembly having a first position and a second position relative to the second reaction container when the pin assembly is inserted into the second reaction container; When the pin assembly is in the first position, the first reactant in the first reaction container flows into the second reaction container, and the gas in the second reaction container is discharged through the pin assembly. When the needle assembly is in the second position, the synthesized drug flows into the dispensing container through the needle assembly, and the gas outside the second reaction container flows into the second reaction container through the needle assembly.

2. The drug production system according to claim 1, characterized in that, The drug production system further includes a first drive module, which can drive the second reaction vessel to move so that the first reactant and the second reactant in the second reaction vessel are mixed.

3. The drug production system according to claim 2, characterized in that, The first drive module is configured to drive the second reaction vessel to reciprocate along a first direction, which is the height direction of the drug production system.

4. The drug production system according to claim 1, characterized in that, The drug production system further includes a support base having a placement space with an open end for placing the second reaction container; when the second reaction container is placed in the placement space, the neck and mouth of the second reaction container are exposed from the open end of the placement space.

5. The drug production system according to claim 4, characterized in that, The drug synthesis apparatus further includes: a heating device disposed within the support base, the heating device being used to heat the second reaction vessel; and / or the support base, the second reaction vessel, and the needle assembly being arranged along a first direction, with the second reaction vessel located between the support base and the needle assembly, the first direction being the height direction of the drug production system.

6. The drug production system according to claim 1, characterized in that, The drug synthesis apparatus also includes: A heat dissipation device, the heat dissipation device being used to cool the second reaction vessel; The drug production system further includes: a first drive module, which can drive the second reaction vessel to move, and the heat dissipation device is fixed to the first drive module.

7. The drug production system according to claim 6, characterized in that, Along a first direction, at least a portion of the heat dissipation device and the second reaction vessel are located on the same side of the first drive module, the first direction being the height direction of the drug production system.

8. The drug production system according to claim 6, characterized in that, The heat dissipation device has an air blowing port, through which air is blown onto the second reaction vessel.

9. The drug production system according to claim 8, characterized in that, The air vent extends along the depth direction of the second reaction vessel.

10. The drug production system according to claim 1, characterized in that, The drug synthesis apparatus further includes: a first shielding and radiation protection structure, which surrounds the second reaction vessel and is constructed in an arc shape.

11. The drug manufacturing system according to claim 10, characterized in that, The first radiation shielding structure includes at least one shielding part, which is closer to the operator than the second reaction vessel.

12. The drug production system according to claim 10, characterized in that, The drug synthesis apparatus further includes a second drive module connected to the first shielding and radiation protection structure. The second drive module is used to drive the first shielding and radiation protection structure to move so that the first shielding and radiation protection structure remains around the second reaction container.

13. The drug manufacturing system according to claim 12, characterized in that, The second drive module can drive the first shielded radiation protection structure to move in the same direction as the second reaction vessel.

14. The drug manufacturing system according to claim 13, characterized in that, The second drive module can drive the first shielded radiation protection structure to move synchronously with the second reaction container.

15. The drug manufacturing system according to any one of claims 1-14, characterized in that, The drug dispensing device further includes a multi-port component, the second conveying component connects the needle assembly and the multi-port component, the second conveying component connects to the dispensing container through the multi-port component, and the multi-port component is movable to connect or separate from the dispensing container.

16. The drug manufacturing system according to claim 15, characterized in that, When the first reactant flows from the first reaction vessel into the second reaction vessel, the multi-port component separates from the dispensing container; When the synthesized drug flows into the dispensing container, the multi-port is connected to the dispensing container.

17. The drug manufacturing system according to any one of claims 1-14, characterized in that, The drug dispensing device further includes: a second shielding and radiation protection structure, which is used to place the dispensing container. The second shielding and radiation protection structure forms a shielding groove with one end open, which is used to place the dispensing container.

18. The drug manufacturing system according to any one of claims 1-14, characterized in that, The pin assembly includes: a first pin and a second pin, wherein the length of the first pin is greater than the length of the second pin; When the pin assembly is in the first position, the first pin is inserted into the second reaction vessel and remains separated from the prepared solvent in the second reaction vessel during the synthesis process, so that the gas in the second reaction vessel can be discharged through the first pin; When the needle assembly is in the second position, both the first needle and the second needle are inserted into the second reaction vessel, and the first needle is inserted into the synthesized drug so that the synthesized drug is discharged through the first needle. During the dispensing process, the second needle is kept apart from the synthesized drug so that gas outside the second reaction vessel can enter the second reaction vessel through the second needle.

19. The drug manufacturing system according to claim 18, characterized in that, The first pin and the second pin are independent of each other.

20. The drug manufacturing system according to claim 18, characterized in that, The inner diameter of the second pin is larger than the outer diameter of the first pin. The second pin is sleeved on the outside of the first pin, and the first pin and the second pin are spaced apart to form a gap between the first pin and the second pin, so that gas outside the second reaction vessel can enter the second reaction vessel through the gap.

21. The drug production system according to claim 15, characterized in that, During the synthesis process, both the first driving mechanism and the second driving mechanism are working and the multi-port is separated from the dispensing container, so that when the first reactant in the first reaction container flows into the second reaction container, the gas in the second reaction container is discharged through the pin assembly and the multi-port.

22. An isolation cabinet, characterized in that, include: A drug manufacturing system, wherein the drug manufacturing system is the drug manufacturing system according to any one of claims 1-21; The cabinet contains the drug production system.

23. A method for producing a drug, characterized in that, The pharmaceutical manufacturing system described in any one of claims 1-21 is characterized in that the pharmaceutical manufacturing method comprises the following steps: S1: The second reaction container is moved relative to the pin assembly by the first drive module so that the pin assembly moves to a first position. At the first position, the first pin of the pin assembly is inserted into the second reaction container. S2: The first peristaltic pump drives the reagent to flow through the nuclide generator and the first reactant washed off flows into the second reaction vessel through the first pipeline. It mixes with the second reactant in the second reaction vessel to form the preparation solvent. The gas in the second reaction vessel is discharged through the first needle. During the washing process, the first needle is separated from the preparation solvent in the second reaction vessel. S3: Drive the second reaction vessel to move away from the pin assembly via the first drive module; S4: The second reaction container is driven to reciprocate along the first direction by the first driving module to mix the prepared solvent in the second reaction container, and the synthetic drug is formed in the second reaction container; S5: The second reaction container continues to move relative to the pin assembly through the first drive module so that the pin assembly moves to the second position. At the second position, the first pin is inserted into the synthetic drug in the second reaction container, and the second pin of the pin assembly is separated from the preparation solvent. S6: The third drive module drives the multi-port component to connect with the dispensing container, and the second peristaltic pump drives the synthetic drug to be delivered into the dispensing container through the first needle, the second pipeline and the multi-port component. S7: After setting the dispensing activity or volume parameters, the second peristaltic pump stops working when the preset amount of synthetic drug in the dispensing container is reached. S8: The third drive module drives the multi-channel component to separate from the dispensing container and places the dispensing container in the first activity detection device for activity detection. Once the activity detection value reaches the standard, the dispensing is completed in one go.

24. The method for producing a drug according to claim 23, characterized in that, After or simultaneously with the first driving module moving the second reaction vessel, the following steps are also included: The second drive module drives the first shielded radiation protection structure to move synchronously with the second reaction container.

25. The method for producing a drug according to claim 23, characterized in that, Step S4, after shaking the prepared solvent, further includes the following steps: S4.1: Drive the second reaction container toward the support base via the first drive module so that the second reaction container moves into the placement space of the support base; S4.2: Place the second reaction vessel in the placement space and let it stand for a period of time to wait for drug synthesis.

26. The method for producing a drug according to claim 23, characterized in that, Step S4, after shaking the prepared solvent, further includes the following steps: S4(a): Drive the second reaction container toward the support base via the first drive module so that the second reaction container moves into the placement space of the support base; S4(b): The heating device inside the support base heats the second reaction vessel; S4(c): The first drive module drives the second reaction vessel to move away from the support base; S4(d): During the movement, the heat dissipation device cools the second reaction vessel.

27. The method for producing a drug according to claim 23, characterized in that, Step S6, after connecting the multi-port component to the dispensing container, also includes an emptying process, which includes the following steps: S6.1: The second peristaltic pump delivers a portion of the synthesized drug from the second reaction vessel into the dispensing container to purge the air from the second pipeline; S6.2: The multi-channel component is driven to separate from the packaging container by the third drive module; S6.3: Replace with a new dispensing container; S6.4: The third drive module drives the multi-channel component to connect with the new dispensing container, and the second peristaltic pump delivers the synthetic drug from the second reaction container to the new dispensing container.

28. The method for producing a drug according to claim 23, characterized in that, Before step S1, a preparation process for the drug production system may also be included, specifically including the following steps: S0.1: Perform a self-inspection of the drug production system; S0.2: Add the required amount of drug powder to the second reaction container, inject water for injection into the second reaction container, shake thoroughly to dissolve, and then install the second reaction container on the support base; S0.3: Connect the reagent to the generator inlet of the radionuclide generator; S0.4: Connect one end of the first pipeline to the generator outlet of the nuclide generator, install at least a portion of the first pipeline in the first extrusion groove of the first peristaltic pump, and connect the other end of the first pipeline to the second reaction vessel; S0.5: Connect one end of the second pipeline to the first pin, install at least a portion of the second pipeline into the second extrusion groove of the second peristaltic pump, and connect the other end of the second pipeline to the multi-port, while keeping the multi-port disconnected from the dispensing container; S0.6: Install the pin assembly into place.

29. The method for producing a drug according to claim 28, characterized in that, The preparation process may be followed by the following steps after the preparation process and before step S1: starting the first peristaltic pump and the second peristaltic pump so that during the rinsing process, the gas in the second reaction vessel is discharged through the first needle, the second pipeline and the multi-port.

30. The method for producing a drug according to claim 23, characterized in that, Before step S1, the following step may also be included: starting the heating device for preheating.

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