CN217248849U - Automatic radiopharmaceutical synthesis device for multi-batch [18F ] AlF aluminum fluoride labeling - Google Patents
Automatic radiopharmaceutical synthesis device for multi-batch [18F ] AlF aluminum fluoride labeling Download PDFInfo
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Abstract
The application belongs to the technical field of nuclear medicine and molecular imaging, and discloses a method for preparing multi-batch [ alpha ], [ beta ] -cyclodextrin 18 F]The automatic AlF aluminum fluoride labeled radiopharmaceutical synthesis device comprises a first injection pump, a second injection pump, a 1-way 9 distribution valve, a 1-way 6 distribution valve, a first two-position six-way valve, a second two-position six-way valve and a firstA two-position four-way valve, a second two-position four-way valve, a third two-position four-way valve, a transfer bottle, a cleaning solution bottle, a physiological saline bottle, an injection water bottle, an ethanol bottle, a product collecting bottle, a waste liquid bottle and H 2 18 An O recovery bottle, a buffer liquid bottle, 18 F, a leaching solution bottle, a solid phase extraction column, a micro anion exchange column, an activity transfer tube, a first heating marking component and a second heating marking component. Through the mutual cooperation of all the valves, all the working procedures can be independently completed, and the whole automatic operation process can also be completed by executing in sequence. The arrangement of a plurality of groups of heating mark components can realize multi-batch 18 F]Fully automatic preparation of AlF aluminum fluoride radiopharmaceuticals.
Description
Technical Field
The utility model relates to the technical field of nuclear medicine and molecular imaging, in particular to a multi-batch nuclear magnetic resonance imaging device 18 F]An automated synthesis device for AlF aluminum fluoride labeled radiopharmaceuticals.
Background
Positron Emission Tomography (PET) imaging is to observe and research in vivo physiological mechanisms through a positron imaging agent, and obtain in vivo metabolic pathways, biomolecular mechanisms, receptor and enzyme functions and other information in real time, in vivo and non-invasively. PET has been widely used in diagnosis of tumor, neurodegenerative disease, etc. as one of the modern advanced functional molecular imaging techniques.
The development of the application of PET technology is key to the development of PET imaging agents. Because the half-life period of the positive electron nuclide is short, the labeling method of the PET imaging agent has the characteristics of less required steps, short reaction time, high efficiency, convenience in operation and the like. Based on [ 2 ] developed in recent ten years 18 F]The AlF aluminum fluoride radioactive labeling strategy has proved to be a novel positron nuclide labeling technology, which has many advantages, such as mild labeling conditions, simple purification process, and the preparation and distribution of multi-patient dosage. The labeling method has been successful in labeling a variety of polypeptides, proteins and small molecules as PET imaging agents, some of which have been used in clinical studies. However, due to the limitation of operation process, most of the current imaging agents are synthesized by manual operation, and the imaging agents can only be prepared in small dose because of the radiation dose and safety problems of operators 18 F]The AlF imaging agent can not meet the requirements of clinical research, and is not beneficial to the radiation protection of operators, so that the popularization and the application of the method marking method in clinic are limited.
The patent number is ZL 202020223654.1, and the name is used for the [ alpha ], [ beta ] -an 18 F]AlF aluminum fluoride labelledA Chinese medicine for automatically synthesizing radioactive medicine is disclosed 18 F]An automated synthesis apparatus for an AlF aluminum fluoride-labeled radiopharmaceutical, which apparatus is incorporated in 18 F]The AlF marking process has the characteristics that a device with high automation degree and high marking efficiency is designed in a targeted manner. The above device can complete the [ alpha ], [ beta ] 18 F]The full-automatic synthesis of the AlF developer has the following defects: cannot be automatically synthesized in batches for many times. The single bombardment and the single synthesis of an accelerator can be realized, and the function of preparation as required can not be realized according to the number of patients individually, so that the cost of medicine synthesis is increased, and the expense borne by individual patients is increased.
SUMMERY OF THE UTILITY MODEL
In order to solve the above problem, the present invention provides a method for producing a multi-batch of [ alpha ], [ beta ] or [ beta ] forms 18 F]An automated synthesis device for AlF aluminum fluoride labeled radiopharmaceuticals.
The above technical purpose of the present invention can be achieved by the following technical solutions: for multi-batch [ 2 ] 18 F]Automatic synthetic device of radiopharmaceutical of AlF aluminium fluoride mark, including first syringe pump, first syringe pump is connected with 1 logical 9 distributing valves, 1 logical 9 distributing valves are connected first two-position six-way valve, first two-position cross valve, transfer bottle, washing liquid bottle, normal saline bottle, water bottle for injection, ethanol bottle, atmosphere respectively, product receiving flask, waste liquid bottle, solid-phase extraction post are connected respectively to first two-position six-way valve, second two cross valves, second two six-way valve are connected respectively to first two cross valves, third two cross valves and first heating mark subassembly are connected to second two cross valves, second two cross valves connect second heating mark subassembly, 1 logical 6 distributing valves, H are connected respectively to second two six-way valve 2 18 An O recovery bottle, 18 F a washing liquid bottle, a miniature anion exchange column and an accelerator, wherein the 1-way 6 distribution valve is respectively connected with the second injection pump, the water bottle for injection, the waste liquid bottle, the buffer liquid bottle, 18 F, a shower lotion bottle and the atmosphere.
Through adopting above-mentioned technical scheme, set up 1 and lead to 9 distributing valves, first two-position six-wayThe valves, the second two-position six-way valve, the first two-position four-way valve, the second two-position four-way valve, the third two-position four-way valve and the 1-way 6 distribution valve are matched with each other, so that the working procedures can be independently completed, and the whole automatic operation process can be performed in sequence. By arranging a plurality of groups of heating mark components, the multi-batch [ 2 ] can be realized 18 F]The full-automatic preparation of the AlF aluminum fluoride radiopharmaceuticals does not need manual intervention between different batches.
Further, the first heating mark assembly comprises a first reaction tube, a first temperature control module and a first cooling fan, and the first temperature control module heats liquid in the first reaction tube; the second heating mark assembly comprises a second reaction pipe, a second temperature control module and a second cooling fan, and the second temperature control module heats liquid in the second reaction pipe.
By adopting the technical scheme, independent temperature control can be realized for different heating marking components, and the simultaneous heating process of a plurality of groups of heating components is realized in a cascading mode, so that multi-batch heating marking is realized.
Further, the second two-position six-way valve, the 1-way 6 distribution valve, the second injection pump and the first two-position four-way valve act 18 F, ion concentration and leaching; the heating marking process is carried out through the actions of the second two-position four-way valve, the first heating marking assembly, the third two-position four-way valve and the second heating marking assembly; the product purification process is performed by the action of a 1-way 9-way distribution valve, a first syringe pump and a first two-position six-way valve.
By adopting the technical scheme, the method has the advantages that, 18 the F ion concentration leaching process, the heating marking process and the product purification process are mutually independent, the contact ratio of the whole pipeline is low, 18 the F ion concentration and leaching process is independent of the product purification process, and pipeline cross contamination under the condition of multi-batch synthesis is effectively avoided.
Furthermore, the first two-position four-way valve is also connected with a transfer pipe.
By adopting the technical scheme, the first two-position four-way valve is provided with the transfer pipe, so that the transfer pipe can be connected with the first two-position four-way valve 18 Transfer pipe for temporary storage of F-type leacheateThen, as required, the specific volume is added 18 Transferring the F leacheate into a designated reaction tube to realize multi-batch quantitative synthesis.
Furthermore, a quantitative pipe is arranged between the first two-position four-way valve and the second two-position six-way valve, and the quantitative pipe is realized through the states of the second two-position six-way valve, the first two-position four-way valve and the second two-position four-way valve 18 Quantitative and directional transfer of the F leacheate.
By adopting the technical scheme, the quantitative tube and the transfer tube can be used for temporary storage 18 F leacheate, by adjusting the state of the first two-position four-way valve 18 F leacheate is blown into the reaction tube to realize 18 Elution quantitative directional transfer of F ions.
Furthermore, a sterile filter membrane with low protein adsorption is arranged at the bottle mouth of the product collecting bottle.
By adopting the technical scheme, the aseptic filter membrane is arranged at the bottle mouth of the product collecting bottle, so that the obtained product is prevented from being infected by external bacteria, and an aseptic product is obtained.
To sum up, the utility model discloses following beneficial effect has:
1. in this application, through setting up 1 logical 9 distributing valves, first two-position six way valve, second two-position six way valve, first two-position four way valve, second two-position four way valve, third two-position four way valve and 1 logical 6 distributing valves, through the mutually supporting between each valve, both can independently accomplish each process, also can carry out according to the order and accomplish whole automation operation flow. By arranging a plurality of groups of heating mark components, multi-batch [ 2 ] 18 F]The full-automatic preparation of the AlF aluminum fluoride radiopharmaceuticals does not need manual intervention among different batches;
2. in this application, through setting up transit tube and ration pipe, can be earlier with 18 Temporarily storing the F leacheate in a transfer tube, and adding the F leacheate in a specific volume according to the requirement 18 Transferring the F-leaching solution to a quantitative pipe, and finally adjusting the state of a first two-position four-way valve to enable the F-leaching solution to flow into the quantitative pipe 18 Quantitatively and directionally transferring the F leacheate into a specified reaction tube to realize quantitative synthesis of multiple batches;
3. in the present application, it is preferred that, 18 f ion concentration leaching processThe heating marking process and the product purification process are independent from each other, the contact ratio of the whole pipeline is low, 18 the F ion concentration and leaching process is independent of the product purification process, and pipeline cross contamination under the condition of multi-batch synthesis is effectively avoided.
Drawings
FIG. 1 is a flow chart of the multi-batch synthesis of the embodiment of the present invention;
FIG. 2 is a flow chart of a single synthesis of an embodiment of the present invention;
in the figure: SP1, first syringe pump; DV1, 1-way 9-way dispensing valve; SP2, second syringe pump; DV2, 1-way 6 dispensing valve; SV1, a first two-position six-way valve; SV2, a second two-position six-way valve; RZ1, a first two-position four-way valve; RZ2, a second two-position four-way valve; RZ3, a third two-position four-way valve; 11. transferring the bottle; 12. cleaning solution bottles; 13. a physiological saline bottle; 14. a water bottle for injection; 15. an ethanol bottle; 16. a product collection bottle; 17. a waste liquid bottle; 18. h 2 18 O, recycling a bottle; 19. a buffer liquid bottle; 20. 18 f, a spray rinsing liquid bottle; 21. a solid phase extraction column; 22. a mini anion exchange column; 23. an accelerator; 24. a transit tube; 30. a first heating marker assembly; 31. A first reaction tube; 32. a first temperature control module; 33. a first heat dissipation fan; 40. a second heat marking assembly; 41. a second reaction tube; 42. a second temperature control module; 43. a second heat dissipation fan; 60. and (4) quantifying the tube.
Detailed Description
The technical solution in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application; it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all embodiments, and all other embodiments obtained by those of ordinary skill in the art without any inventive work based on the embodiments in the present application belong to the protection scope of the present application.
As shown in FIGS. 1-2, the examples of the present application disclose a method for multi-batch [ alpha ], [ beta ] -an 18 F]The AlF aluminum fluoride labeled radiopharmaceutical automatic synthesis device comprises a first syringe pump SP1, a second syringe pump SP2, a 1-way 9-distribution valve DV1 and 1A 6-way distribution valve DV2, a first two-position six-way valve SV1, a second two-position six-way valve SV2, a first two-position four-way valve RZ1, a second two-position four-way valve RZ2, a third two-position four-way valve RZ3, a transfer bottle 11, a cleaning solution bottle 12, a physiological saline bottle 13, an injection water bottle 14, an ethanol bottle 15, a product collecting bottle 16, a waste liquid bottle 17, an H 2 18 An O recovery bottle 18, a buffer liquid bottle 19, 18 An F leacheate bottle 20, a solid phase extraction column 21, a micro anion exchange column 22, an accelerator 23, a transfer tube 24, a first heating mark component 30 and a second heating mark component 40.
Specifically, the dead volume of the flow path channel of the 1-way 9-way distribution valve DV1 is less than 20 uL. The product collection bottle 16 is provided with a sterile filter membrane at the bottle mouth, the sterile filter membrane is preferably a low protein adsorption sterile filter membrane, and can filter ethanol organic solvent. The solid phase extraction column 21 is preferably a C18 column or an HLB column, and the activation method is that 5mL of ethanol is firstly used for washing the column, then 10mL of water for injection is used for washing, and finally the column is dried for standby; the activation process can be completed manually in advance or automatically. The accelerator 23 is a medical cyclotron. The range of the first syringe pump SP1 was 5mL, the range of the second syringe pump SP2 was 2.5mL, and the volume of the dosing tube 60 was 500 uL.
The first heating mark assembly 30 includes a first reaction tube 31, a first temperature control module 32 and a first heat dissipation fan 33, wherein the first temperature control module 32 heats the liquid in the first reaction tube 31; the second heating mark assembly 40 includes a second reaction tube 41, a second temperature control module 42 and a second heat dissipation fan 43, wherein the second temperature control module 42 heats the liquid in the second reaction tube 41. The first temperature control module 32 and the second temperature control module 42 both comprise heating rods and heat-conducting aluminum ingots, the heating rods are arranged in the heat-conducting aluminum ingots, and heating grooves for placing reaction tubes are processed on the heat-conducting aluminum ingots; the heat conducting aluminum ingot is also provided with a radiating fin, and after heating is finished, the reaction tube can be quickly cooled by controlling the radiating fan. The first reaction tube 31 and the second reaction tube 41 are preferably composed of 2.0mL cryopreservation tubes and matching PEEK sealing parts.
The measuring range of the first injection pump SP1 is 5mL, and a liquid outlet of the first injection pump SP1 is fixedly connected with a liquid inlet of a 1-way 9-distribution valve DV 1; the 1 channel of the 1-way 9-way distribution valve DV1 is connected with the 1 channel of the first two-position four-way valve RZ1, the 2 channel is connected with the transfer bottle 11, the 3 channel is connected with the cleaning liquid bottle 12, the 4 channel is connected with the 5 channel of the first two-position six-way valve SV1, the 5 channel is connected with the physiological saline bottle 13, the 6 channel is connected with the 2 channel of the first two-position six-way valve SV1, the 7 channel is connected with the water bottle for injection 14, the 8 channel is connected with the ethanol bottle 15, and the 9 channel is connected with the atmosphere.
The 1 channel of the first two-position six-way valve SV1 is connected with the top end of the solid phase extraction column 21, the 2 channel is connected with the 6 channel of the 1-way 9-way distribution valve DV1, the 3 channel is connected with the product collecting bottle 16, the 4 channel is connected with the bottom end of the solid phase extraction column 21, the 5 channel is connected with the 4 channel of the 1-way 9-way distribution valve DV1, and the 6 channel is connected with the waste liquid bottle 17. The 1-bit state of the first two-position six-way valve SV1 is: the channel 1 is communicated with the channel 6, the channel 2 is communicated with the channel 3, and the channel 4 is communicated with the channel 5; the 2-bit state of the first two-position six-way valve SV1 is: the channel 1 is communicated with the channel 2, the channel 3 is communicated with the channel 4, and the channel 5 is communicated with the channel 6.
A channel 1 of the first two-position four-way valve RZ1 is communicated with a channel 1 of a 1-way 9 distribution valve DV1, a channel 2 is connected with the transfer pipe 24, a channel 3 is connected with a channel 3 of the second two-position six-way valve SV2, and a channel c is connected with a channel c of the second two-position four-way valve RZ 2. The 1-position state of the first two-position four-way valve RZ1 is: the channel 1 is communicated with the channel c, and the channel 2 is communicated with the channel 3; the 2-position state of the first two-position four-way valve RZ1 is as follows: channel 1 communicates with channel 2 and channel 3 communicates with channel c.
The 1 and 2 channels of the second two-position four-way valve RZ2 are communicated with the first reaction pipe 31, the 3 channel is communicated with the c channel of the third two-position four-way valve RZ3, and the c channel is communicated with the c channel of the first two-position four-way valve RZ 1. The 1-bit state of the second two-bit four-way valve RZ2 is: the channel 1 is communicated with the channel c, and the channel 2 is communicated with the channel 3; the 2-bit state of the second two-bit four-way valve RZ2 is: channel 1 communicates with channel 2 and channel 3 communicates with channel c.
The 1 and 2 channels of the third two-position four-way valve RZ3 are communicated with the second reaction tube 41, the 3 channel is reserved, and the c channel is communicated with the c channel of the second two-position four-way valve RZ 2. The 1-bit state of the third two-position four-way valve RZ3 is: the channel 1 is communicated with the channel c, and the channel 2 is communicated with the channel 3; the 2-bit state of the third two-position four-way valve RZ3 is: channel 1 communicates with channel 2 and channel 3 communicates with channel c.
1 channel and of the second two-position six-way valve SV2The top end of the micro anion exchange column 22 is communicated, the 2 channel is communicated with the 2 channel of the 1-way 6-way distribution valve DV2, the 3 channel is communicated with the 3 channel of the first two-position four-way valve RZ1, the 4 channel is communicated with the bottom end of the micro anion exchange column 22, the 5 channel is connected with the accelerator 23, and the 6 channel is connected with the H 2 18 O recovery bottle 18. The 1-bit state of the second two-position six-way valve SV2 is: the channel 1 is communicated with the channel 6, the channel 2 is communicated with the channel 3, and the channel 4 is communicated with the channel 5; the 2-bit state of the second two-position six-way valve SV2 is: channel 1 communicates with channel 2, channel 3 communicates with channel 4, and channel 5 communicates with channel 6.
The 1 channel of the 1-way 6-way distribution valve DV2 is connected with the water bottle for injection 14, the 2 channel is communicated with the 2 channel of the second two-position six-way valve SV2, the 3 channel is connected with the buffer liquid bottle 19, and the 4 channel is connected with the buffer liquid bottle 18 The passage F of the leacheate bottle 20 is connected with the passage 5 of the waste liquid bottle 17, the passage 6 of the leacheate bottle is connected with the atmosphere, and the liquid inlet end of the leacheate bottle is fixedly connected with the liquid outlet end of the second injection pump SP 2.
In this embodiment, one is used for multiple batches 18 F]The AlF aluminum fluoride labeled radiopharmaceutical automatic synthesis device comprises the following single automatic synthesis process:
1. preparation before Synthesis
A1-way 9-way distribution valve DV1 is connected with a 5-way 50mL physiological saline bottle 13, a 7-way 100mL sterile water bottle for injection 14, an 8-way 50mL ethanol bottle 15 and a 9-way air.
The labeled precursor in this example was NOTA-TATE, stored in advance in a 2mL cryopreservation tube, and existed in the form of lyophilized powder, and the lyophilized powder had a material composition of NOTA-TATE 100ug, alcl3.6h2o 3ug, and the cryopreservation tube served as a reaction tube for labeling reaction.
The product purification solid phase extraction column 21 model: sep-pak C18 Light, Waters. Before use, the method needs to activate the active agent, and comprises the following steps: the column was rinsed with 5mL of ethanol, then 10mL of ultra-pure water, and finally dried for further use.
18 Type F concentration micro anion exchange column 22: KT-101, Huayi. Before use, the method needs activation treatment, and comprises the following steps: the column was rinsed with 5mL of normal saline, then 10mL of ultra pure water, and finally dried for further use.
Model of sterile filter membrane: MILLEX-GV, SLGV013SL，
Is packaged independently and aseptically, and can be used directly without activation.
2. 18 F ion concentration and elution operation
2.1 18 F is trapped on a mini anion exchange column 22
The second two-position six-way valve SV2 is put into the 1-position state, and the accelerator 23 is operated 18 F-H 2 18 O target water (100-200mCi, 2.5mL) was blown onto the mini anion exchange column 22 through helium, and the whole process lasted for 5min, ensuring that 18 F was completely adsorbed on the mini anion exchange column 22 and blown dry. H 2 18 The O target water enters H through the 1 channel and the 6 channel of the second two-position six-way valve SV2 2 18 O recovery bottle 18.
2.2 concentration of the elution 18 F and transferred to the reaction tube
The 1-way 6-way distribution valve DV2 is positioned at the 4-way and connected 18 The F-eluent bottle 20 is filled with an eluent, 18 the F leacheate bottle 20 is filled with 0.9 percent of normal saline as 18 F leacheate, and 150uL of normal saline is extracted by a second injection pump SP2 to serve as 18 F, leacheate; the second two-position six-way valve SV2 is set to 2-position state, the first two-position four-way valve RZ1 is set to 2-position state, the second two-position four-way valve RZ2 is set to 1-position state, and the second injection pump SP2 passes 150uL of physiological saline through the miniature anion exchange column 22 at the speed of 5 uL/s; then the 1-way 6 distribution valve DV2 is positioned at the 6-way to be connected with the atmosphere, the second injection pump SP2 pumps 2mL of air, and then the 1-way 6 distribution valve DV2 is positioned at the 2-way to blow the liquid in the pipeline into the first reaction tube 31, so that the effect is realized 18 And (4) leaching and concentrating F ions.
3.[ 18 F]Coupling of AlF to a labelling precursor
3.1 addition of buffer solution
Placing a 1-way 6-way distribution valve DV2 in a 3-channel connection buffer solution bottle 19, and extracting 350uL of buffer solution; then the 1-way 6 distribution valve DV2 is placed in a 2-way channel, the second two-position six-way valve SV2 is placed in a 1-position state, the first two-position four-way valve RZ1 is placed in a 2-position state, the second two-position four-way valve RZ2 is placed in a 1-position state, 350uL of buffer solution is transferred to the first reaction tube 31, and 18F concentrated leacheate is ready to be received.
3.2 seal the heating mark
Setting the first temperature control module 32 to be 105 ℃, setting the second two-position four-way valve RZ2 to be 2 positions, sealing the whole first reaction tube 31, heating for reaction for 14min, after the marking reaction is finished, starting the first cooling fan 33 to cool the first reaction tube 31 for 2min until the temperature is lower than 65 ℃, and finally setting the second two-position four-way valve RZ2 to be 1 position.
4. Purifying the product by solid phase extraction
4.1 dilution of the product liquid
Placing the first two-position four-way valve RZ1 in a 1-position state, placing the second two-position four-way valve RZ2 in a 1-position state, placing a 1-way 9 distribution valve DV1 in a 1-channel, and transferring all liquid in the first reaction pipe 31 into a first injection pump SP 1; placing the 1-way 9-way distribution valve DV1 on the 2-way channel, and transferring the liquid in the first syringe pump SP1 to the transfer bottle 11; placing a 1-way 9-distribution valve DV1 in a 7-way channel to be connected with an injection water bottle 14, sucking 4mL of injection water by a first injection pump SP1, then placing a 1-way 9-distribution valve DV1 in a 2-way channel, transferring the injection water in the first injection pump SP1 to a transfer bottle 11, repeating twice, namely transferring 8mL of injection water to the transfer bottle 11 in total, and diluting the reaction liquid to ensure that the content of organic solvent is not more than 5%.
4.2 hanging column of product
The 1-way 9-way distribution valve DV1 is placed in the 2-way, and the diluent in the transfer bottle 11 is transferred to the first syringe pump SP 1; the 1-way 9-way distribution valve DV1 is placed in the 4-way, the first two-position six-way valve SV1 is placed in the 1-position state, the first syringe pump SP1 transfers the diluent to the solid-phase extraction column 21 at the speed of 100uL/s, and the steps are repeated until the diluent in the transfer bottle 11 is completely transferred to the solid-phase extraction column 21.
4.3 washing and blowing dry of the solid-phase extraction column 21
A 1-way 9-way distribution valve DV1 is arranged at a 7-way channel to be connected with an injection water bottle 14, and a first injection pump SP1 sucks 5mL of injection water; placing 1-way 9-way distribution valve DV1 in 4-way, placing first two-position six-way valve SV1 in 1-way state, flushing solid phase extraction column 21 with first syringe pump SP1 at 200uL/s, and repeatingRepeating the above operation for 3 times to ensure separation of the upper stream of the solid phase extraction column 21 18 F, washing by ions; placing a 1-way 9 distribution valve DV1 in a 9-channel atmosphere, sucking 5mL of air by a first injection pump SP1, placing a 1-way 9 distribution valve DV1 in a 4-channel atmosphere, placing a first two-position six-way valve SV1 in a 1-position state, drying the solid phase extraction column 21 by the first injection pump SP1 at the speed of 1000uL/s, and repeating the operation for 3 times to ensure that no obvious liquid drops are left in the solid phase extraction column 21.
4.4 rinsing the product to the product collecting bottle 16
Placing a 1-way 9 distribution valve DV1 in an 8-channel ethanol bottle 15, sucking 700uL of ethanol by a first injection pump SP1, placing a 1-way 9 distribution valve DV1 in a 6-channel ethanol bottle, placing a first two-position six-way valve SV1 in a 2-position state, washing a product from a solid-phase extraction column 21 by the first injection pump SP1 at the speed of 100uL/s, performing aseptic treatment by using an aseptic filter membrane 51, and transferring the product to a product collecting bottle 16; the 1-way 9-way dispensing valve DV1 was set to the 9-way atmosphere and the first syringe pump SP1 pulled 5mL of air and the above steps were repeated until the product was completely transferred to the product collection bottle 16.
4.5 diluted product leacheate
Placing a 1-way 9-way distribution valve DV1 in a 5-channel physiological saline bottle 13, sucking 5mL of physiological saline by a first injection pump SP1, placing a 1-way 9-way distribution valve DV1 in a 6-channel, placing a first two-position six-way valve SV1 in a 1-position state, and completely transferring the physiological saline in the first injection pump SP1 into a product collecting bottle 16 through a sterile filter membrane; the above operation is repeated 2 times, so that the ethanol content in the product collecting bottle 16 is not more than 10%.
The above steps are carried out in a second reaction tube by cascading a second heat marker assembly 40 after the first heat marker assembly 30 18 The F ions are leached, concentrated and heated, and the solution can be continuously used for 2 times 18 F]Fully automatic preparation of AlF aluminum fluoride radiopharmaceuticals. Preferably, the number of the heating mark components is increased as required, and the effect of multiple times can be realized 18 F]Fully automatic preparation of AlF aluminum fluoride radiopharmaceuticals.
In this embodiment, one is used for multiple batches 18 F]The automatic AlF aluminum fluoride labeled radiopharmaceutical synthesis device comprises the following multiple quantitative synthesis procedures:
1. preparation before Synthesis
A1-way 9-way dispensing valve DV1 is connected with a 5-way 50mL physiological saline bottle 13, a 7-way 100mL sterile water bottle for injection 14, a 8-way 50mL ethanol bottle 15 and a 9-way atmosphere.
The labeled precursor in this example was NOTA-TATE, which was stored in a 2mL cryopreservation tube in advance, and was present as a lyophilized powder. The material composition in the first reaction tube 31 is NOTA-TATE 100ug, AlCl3.6H2O 3 ug; the composition of the material in the second reaction tube 41 was NOTA-TATE 50ug, AlCl3.6H2O 1.5 ug.
The product purification solid phase extraction column 21 model: sep-pak C18 Light, Waters. Before use, the method needs activation treatment and comprises the following steps: the column was rinsed with 5mL of ethanol, then 10mL of ultra-pure water, and finally dried for further use.
18 Type F concentration micro anion exchange column 22: KT-101, Huayi. Before use, the method needs activation treatment, and comprises the following steps: the column was rinsed with 5mL of physiological saline, then with 10mL of ultra-pure water, and finally dried for further use.
Model of sterile filter membrane: MILLEX-GV, SLGV013SL,
is packaged independently and aseptically, and can be used directly without activation.
2. 18 F ion concentration and elution operation
2.1 18 F is trapped on a mini anion exchange column 22
The second two-position six-way valve SV2 is put into the 1-position state, and the accelerator 23 is operated 18 F-H 2 18 O target water (200-400mCi, 2.5mL) was blown onto the mini anion exchange column 22 through helium, and the whole process lasted for 5min, ensuring that 18 F was completely adsorbed on the mini anion exchange column 22 and blown dry. H 2 18 The O target water enters H through the 1 channel and the 6 channel of the second two-position six-way valve SV2 2 18 O recovery bottle 18.
2.2 concentration of the elution 18 F and transferred to the transfer pipe 24
Will be led to 6Distribution valve DV2 is set at 4-way, connected 18 F a bottle of the leacheate 20, 18 the F leacheate bottle 20 is filled with normal saline as 18 F leacheate, and a second injection pump SP2 pumps 400uL of normal saline as 18 F, leacheate; the second two-position six-way valve SV2 is set to 2-position state, the first two-position four-way valve RZ1 is set to 1-position state, and the second injection pump SP2 passes 400uL of physiological saline through the miniature anion exchange column 22 at the speed of 5 uL/s; the 1-through 6 distribution valve DV2 is positioned at the 6 channel to be communicated with the atmosphere, the second injection pump SP2 sucks 2mL of air, then the 1-through 6 distribution valve DV2 is positioned at the 2 channel, the states of the two-position six-way valve SV2 and the first two-position four-way valve RZ1 are kept unchanged, and the liquid in the pipeline is blown into the transit pipe 24, so that the effect is realized 18 And (4) leaching and concentrating F ions.
2.3 rinsing the concentrate 18 F is transferred to the first reaction tube 31
The 1-way 6 distribution valve DV2 is arranged at a channel 2, the second two-position six-way valve SV2 is arranged at a position 1, the first two-position four-way valve RZ1 is arranged at a position 1, and the second injection pump SP2 sucks 170uL from the transfer pipe 24 18 F leacheate into dosing tube 60; the first two-position four-way valve RZ1 is set to 2-position state, the second two-position four-way valve RZ2 is set to 1-position state, the third two-position four-way valve RZ3 is set to 2-position state, the second injection pump SP2 stores the liquid in the fixed amount pipe 60 18 The F eluent is transferred to the first reaction tube 31; the 1-way 6 distribution valve DV2 is positioned in a 6-channel communicated atmosphere, a second injection pump SP2 sucks 2mL of air, then the 1-way 6 distribution valve DV2 is positioned in a 2-channel, the states of a second two-position six-way valve SV2, a first two-position four-way valve RZ1 and a second two-position four-way valve RZ2 are kept unchanged, and the liquid in the pipeline is completely blown into a first reaction pipe 31, so that the effect of completely blowing the liquid into the pipeline is realized 18 Elution quantitative directional transfer of F ions.
2.4 drip washing the concentrate 18 F is transferred to the second reaction tube 41
The 1-way 6 distribution valve DV2 is arranged at the 2-way, the second two-position six-way valve SV2 is arranged at the 1-position state, the first two-position four-way valve RZ1 is arranged at the 1-position state, and the second injection pump SP2 sucks 170uL from the intermediate transfer pipe 24 18 F leacheate into dosing tube 60; the first two-position four-way valve RZ1 is set to 2-position state, and the second two-position four-way valveRZ2 is set to 2-position state, RZ3 is set to 1-position state, and the second syringe pump SP2 pumps the liquid stored in the fixed quantity pipe 60 18 The F eluate is transferred to the second reaction tube 41; the 1-way 6 distribution valve DV2 is positioned in a 6-channel communicated atmosphere, the second injection pump SP2 sucks 2mL of air, then the 1-way 6 distribution valve DV2 is positioned in a 2-channel, the states of the second two-position six-way valve SV2, the first two-position four-way valve RZ1 and the second two-position four-way valve RZ2 are kept unchanged, and the liquid in the pipeline is completely blown into the second reaction pipe 41, so that the aim of completely blowing the liquid into the second reaction pipe 41 is fulfilled 18 Elution quantitative directional transfer of F ions.
3.[ 18 F]Coupling of AlF to a labelling precursor
3.1 adding a buffer solution to the first reaction tube 31
Placing a 1-way 6-way distribution valve DV2 in a 3-channel connection buffer solution bottle 19, and extracting 350uL of buffer solution; then, the 1-way 6 distribution valve DV2 was placed in the 2-way, the second two-position six-way valve SV2 was placed in the 1-position state, the first two-position four-way valve RZ1 was placed in the 2-position state, the second two-position four-way valve RZ2 was placed in the 1-position state, the second two-position four-way valve RZ2 was placed in the 2-position state, and 350uL of the buffer solution was transferred to the first reaction tube 31.
3.2 adding a buffer solution to the second reaction tube 41
Placing a 1-way 6-way distribution valve DV2 in a 3-channel connection buffer solution bottle 19, and extracting 350uL of buffer solution; then, the 1-way 6 distribution valve DV2 was placed in the 2-way, the second two-position six-way valve SV2 was placed in the 1-position state, the first two-position four-way valve RZ1 was placed in the 2-position state, the second two-position four-way valve RZ2 was placed in the 2-position state, the second two-position four-way valve RZ2 was placed in the 1-position state, and 350uL of buffer solution was transferred to the second reaction tube 41.
3.2 seal the heating mark
Setting the temperature of the first temperature control module 32 and the temperature of the second temperature control module 42 to 105 ℃, setting the RZ2 position of the second two-position four-way valve at the 2 position, sealing the whole first reaction tube 31, heating for 14min, setting the RZ3 position of the third two-position four-way valve at the 2 position, sealing the whole second reaction tube 41, and heating for 14 min; after the labeling reaction is finished, the first cooling fan 33 and the second cooling fan 43 are started to cool the first reaction tube 31 and the second reaction tube 41 for 2min until the temperature is lower than 65 ℃.
4. The product of the first reaction tube 31 is purified by solid phase extraction
4.1 dilution of the product liquid
Placing a first two-position four-way valve RZ1 in a 1-position state, a second two-position four-way valve RZ2 in a 1-position state, a third two-position four-way valve RZ3 in a 2-position state, a 1-way 9-way distribution valve DV1 in a 1 channel, and transferring all liquid in a first reaction pipe 31 into a first injection pump SP 1; placing a 1-way 9-way distribution valve DV1 on a 2-way channel, and transferring the liquid in a first syringe pump SP1 to a transfer bottle 11; placing a 1-way 9-distribution valve DV1 in a 7-way channel to be connected with an injection water bottle 14, sucking 4mL of injection water by a first injection pump SP1, then placing a 1-way 9-distribution valve DV1 in a 2-way channel, transferring the injection water in the first injection pump SP1 to a transfer bottle 11, repeating twice, namely transferring 8mL of injection water to the transfer bottle 11 in total, and diluting the reaction liquid to ensure that the content of organic solvent is not more than 5%.
4.2 hanging column of product
The 1-way 9-way distribution valve DV1 is placed in the 2-way, and the diluent in the transfer bottle 11 is transferred to the first syringe pump SP 1; the 1-way 9-way distribution valve DV1 is placed in the 4-way, the first two-position six-way valve SV1 is placed in the 1-position state, the first syringe pump SP1 transfers the diluent to the solid-phase extraction column 21 at the speed of 100uL/s, and the steps are repeated until the diluent in the transfer bottle 11 is completely transferred to the solid-phase extraction column 21.
4.3 washing and blowing dry of the solid-phase extraction column 21
Placing a 1-way 9-way distribution valve DV1 at a 7-way channel to be connected with an injection water bottle 14, and sucking 5mL of injection water by a first injection pump SP 1; the 1-way 9-way distribution valve DV1 is placed in the 4-way, the first two-position six-way valve SV1 is placed in the 1-position state, the first syringe pump SP1 washes the solid phase extraction column 21 at the speed of 200uL/s, and the operation is repeated for 3 times to ensure that the upper stream of the solid phase extraction column 21 is separated 18 F, washing by ions; placing a 1-way 9 distribution valve DV1 in a 9-channel atmosphere, sucking 5mL of air by a first injection pump SP1, placing a 1-way 9 distribution valve DV1 in a 4-channel atmosphere, placing a first two-position six-way valve SV1 in a 1-position state, drying the solid phase extraction column 21 by the first injection pump SP1 at the speed of 1000uL/s, and repeating the operation for 3 times to ensure that no obvious liquid drops are left in the solid phase extraction column 21.
4.4 rinsing the product to the product collecting bottle 16
Placing a 1-way 9 distribution valve DV1 in an 8-channel ethanol bottle 15, sucking 700uL of ethanol by a first injection pump SP1, placing a 1-way 9 distribution valve DV1 in a 6-channel ethanol bottle, placing a first two-position six-way valve SV1 in a 2-position state, washing a product from a solid-phase extraction column 21 by the first injection pump SP1 at the speed of 100uL/s, performing aseptic treatment by using an aseptic filter membrane 51, and transferring the product to a product collecting bottle 16; the 1-way 9-way dispensing valve DV1 was set to the 9-way atmosphere and the first syringe pump SP1 pulled 5mL of air and the above steps were repeated until the product was completely transferred to the product collection bottle 16.
4.5 diluted product leacheate
Placing a 1-way 9-way distribution valve DV1 in a 5-channel physiological saline bottle 13, sucking 5mL of physiological saline by a first injection pump SP1, placing a 1-way 9-way distribution valve DV1 in a 6-channel, placing a first two-position six-way valve SV1 in a 1-position state, and completely transferring the physiological saline in the first injection pump SP1 into a product collecting bottle 16 through a sterile filter membrane; the above operation is repeated 2 times, so that the ethanol content in the product collecting bottle 16 is not more than 10%.
5. Reactivation of the solid phase extraction column 21
Placing a 1-way 9 distribution valve DV1 in an 8-channel connection ethanol bottle 15, after a first injection pump SP1 pumps 5mL of ethanol, placing a 1-way 9 distribution valve DV1 in a 4-channel connection, placing a first two-position six-way valve SV1 in a 1-position state, flushing the solid-phase extraction column 21 by the first injection pump SP1 with 5mL of ethanol, then placing a 1-way 9 distribution valve DV1 in a 9-channel connection to the atmosphere, and pumping air by the first injection pump SP1 to blow dry ethanol residues in the solid-phase extraction column 21; the 1-way 9-way distribution valve DV1 was placed in the 7-way water bottle 14, the first syringe pump SP1 was used to draw 5mL of injection water, the 1-way 9-way distribution valve DV1 was placed in the 4-way water bottle, and the first syringe pump SP1 was used to flush the solid phase extraction column 21 with 5mL of injection water, and the above operation was repeated 2 times. Then 1-way 9 distribution valve DV1 is put in the 9-way to be connected to the atmosphere, and the first injection pump SP1 pumps air to blow dry the injection water residue in the solid phase extraction column 21.
6. The product of the second reaction tube 41 is purified by solid phase extraction
6.1 dilution of the product liquid
Placing the first two-position four-way valve RZ1 in a 1-position state, placing the second two-position four-way valve RZ2 in a 2-position state, placing the third two-position four-way valve RZ3 in a 1-position state, placing a 1-way 9-way distribution valve DV1 in a 1 channel, and transferring all liquid in the second reaction tube 41 into a first injection pump SP 1; placing a 1-way 9-way distribution valve DV1 on a 2-way channel, and transferring the liquid in a first syringe pump SP1 to a transfer bottle 11; placing a 1-way 9 distribution valve DV1 on a 7-way water bottle for injection 14, sucking 4mL of water for injection by a first injection pump SP1, placing a 1-way 9 distribution valve DV1 on a 2-way water bottle, transferring the water for injection in the first injection pump SP1 to a transfer bottle 11, repeating twice, transferring 8mL of water for injection to the transfer bottle 11 in total, and diluting the reaction liquid to ensure that the content of organic solvent is not more than 5%.
6.2 product hanging column
Placing a 1-way 9-way distribution valve DV1 on a 2-way channel, and transferring the diluent in the transfer bottle 11 to a first syringe pump SP 1; the 1-way 9 distribution valve DV1 is placed in the 4-way, the first two-position six-way valve SV1 is placed in the 1-position state, the first syringe pump SP1 transfers the diluent to the solid phase extraction column 21 at the speed of 100uL/s, and the steps are repeated until the diluent in the transfer bottle 11 is completely transferred to the solid phase extraction column 21.
6.3 rinsing and blowing Dry the solid phase extraction column 21
A 1-way 9-way distribution valve DV1 is arranged at a 7-way channel to be connected with an injection water bottle 14, and a first injection pump SP1 sucks 5mL of injection water; the 1-way 9-way distribution valve DV1 is placed in the 4-way, the first two-position six-way valve SV1 is placed in the 1-position state, the first syringe pump SP1 washes the solid phase extraction column 21 at the speed of 200uL/s, and the operation is repeated for 3 times to ensure that the upper stream of the solid phase extraction column 21 is separated 18 F, washing by ions; placing a 1-way 9 distribution valve DV1 in a 9-channel atmosphere, sucking 5mL of air by a first injection pump SP1, placing a 1-way 9 distribution valve DV1 in a 4-channel atmosphere, placing a first two-position six-way valve SV1 in a 1-position state, drying the solid phase extraction column 21 by the first injection pump SP1 at the speed of 1000uL/s, and repeating the operation for 3 times to ensure that no obvious liquid drops are left in the solid phase extraction column 21.
6.4 rinsing the product to the product collecting bottle 16
Placing a 1-way 9-way distribution valve DV1 in an 8-way channel and connecting the channel with an ethanol bottle 15, sucking 700uL of ethanol by a first injection pump SP1, placing a 1-way 9-way distribution valve DV1 in a 6-way channel, placing a first two-position six-way valve SV1 in a 2-position state, leaching a product from a solid phase extraction column 21 by the first injection pump SP1 at the speed of 100uL/s, performing sterile treatment by using a sterile filter membrane, and transferring the product to a product collecting bottle 16; the 1-way 9-way dispensing valve DV1 was set to the 9-way atmosphere and the first syringe pump SP1 pulled 5mL of air and the above steps were repeated until the product was completely transferred to the product collection bottle 16.
6.5 diluted product leacheate
Placing a 1-way 9-way distribution valve DV1 in a 5-channel physiological saline bottle 13, sucking 5mL of physiological saline by a first injection pump SP1, placing a 1-way 9-way distribution valve DV1 in a 6-channel, placing a first two-position six-way valve SV1 in a 1-position state, and completely transferring the physiological saline in the first injection pump SP1 into a product collecting bottle 16 through a sterile filter membrane; the above operation is repeated 2 times, so that the ethanol content in the product collecting bottle 16 is not more than 10%.
It is above only the utility model discloses a preferred embodiment, the utility model discloses a scope of protection does not only confine above-mentioned embodiment, the all belongs to the utility model discloses a technical scheme under the thinking all belongs to the utility model discloses a scope of protection. It should be noted that, for those skilled in the art, various modifications and decorations can be made without departing from the principle of the present invention, and these modifications and decorations should also be regarded as the protection scope of the present invention.
Claims (6)
1. Is used for multi-batch [ mu ] n 18 F]Automatic synthesizer of AlF aluminum fluoride labeled radiopharmaceutical, characterized by: comprising a first syringe pump (SP1), said first syringe pump (SP1) being connected to a 1-way 9-way dispensing valve (DV1), the 1-way 9 distribution valve (DV1) is respectively connected with a first two-position six-way valve (SV1), a first two-position four-way valve (RZ1), a transfer bottle (11), a cleaning solution bottle (12), a physiological saline bottle (13), an injection water bottle (14), an ethanol bottle (15) and the atmosphere, the first two-position six-way valve (SV1) is respectively connected with a product collecting bottle (16), a waste liquid bottle (17) and a solid phase extraction column (21), the first two-position four-way valve (RZ1) is respectively connected with a second two-position four-way valve (RZ2) and a second two-position six-way valve (SV2), the second two-position four-way valve (RZ2) connects the third two-position four-way valve (RZ3) and the first heat flag assembly (30), the third two-position four-way valve (RZ3) is connected with a second heating mark assembly (40), and the second two-position six-way valve (SV2) is respectively connected with a 1-way 6 distribution valve.(DV2)、H 2 18 O recovery bottle (18), 18 F a drench liquid bottle (20), a miniature anion exchange column (22) and an accelerator (23), wherein the 1-way 6-way distribution valve (DV2) is respectively connected with a second injection pump (SP2), an injection water bottle (14), a waste liquid bottle (17), a buffer liquid bottle (19), 18 F, a shower lotion bottle (20) and the atmosphere.
2. The composition of claim 1, which is used in multiple batches 18 F]Automatic synthetic device of AlF aluminium fluoride labeled radiopharmaceutical, characterized by: the first heating mark assembly (30) comprises a first reaction tube (31), a first temperature control module (32) and a first cooling fan (33), and the first temperature control module (32) heats liquid in the first reaction tube (31); the second heating mark assembly (40) comprises a second reaction tube (41), a second temperature control module (42) and a second cooling fan (43), and the second temperature control module (42) heats liquid in the second reaction tube (41).
3. The composition of claim 1, for a multiple batch of 18 F]Automatic synthetic device of AlF aluminium fluoride labeled radiopharmaceutical, characterized by: is carried out by the actions of a second two-position six-way valve (SV2), a 1-way 6-way distribution valve (DV2), a second injection pump (SP2) and a first two-position four-way valve (RZ1) 18 F, ion concentration and leaching; a heating and marking process is carried out through the actions of the second two-position four-way valve (RZ2), the first heating and marking assembly (30), the third two-position four-way valve (RZ3) and the second heating and marking assembly (40); the product purification procedure was performed by the 1-way 9 dispensing valve (DV1), the first syringe pump (SP1) and the first two-position six-way valve (SV1) action.
4. The composition of claim 1, for a multiple batch of 18 F]Automatic synthetic device of AlF aluminium fluoride labeled radiopharmaceutical, characterized by: the first two-position four-way valve (RZ1) is also connected with a transfer pipe (24).
5. The composition of claim 4, which is used in multiple batches 18 F]Automatic synthetic device of AlF aluminium fluoride labeled radiopharmaceutical, characterized by: the first two positions are fourA quantitative pipe (60) is arranged between the through valve (RZ1) and the second two-position six-way valve (SV2), and the states of the second two-position six-way valve (SV2), the first two-position four-way valve (RZ1) and the second two-position four-way valve (RZ2) are realized 18 Quantitative and directional transfer of the F leacheate.
6. The composition of claim 1, for a multiple batch of 18 F]Automatic synthetic device of AlF aluminium fluoride labeled radiopharmaceutical, characterized by: and a sterile filter membrane for low protein adsorption is arranged at the bottle mouth of the product collecting bottle (16).
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|---|---|---|---|
| CN202220951249.0U CN217248849U (en) | 2022-04-22 | 2022-04-22 | Automatic radiopharmaceutical synthesis device for multi-batch [18F ] AlF aluminum fluoride labeling |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202220951249.0U CN217248849U (en) | 2022-04-22 | 2022-04-22 | Automatic radiopharmaceutical synthesis device for multi-batch [18F ] AlF aluminum fluoride labeling |
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