CN220803275U - For use in99mTc-labeled radiopharmaceutical automatic synthesis and purification device - Google Patents
For use in99mTc-labeled radiopharmaceutical automatic synthesis and purification device Download PDFInfo
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Abstract
An automatic synthesis and purification device for 99m Tc labeled radiopharmaceuticals belongs to the field of nuclear medicine radiopharmaceuticals synthesis, and comprises an injection pump, two one-way nine-distribution valves, two-position four-way valves, a product purification solid-phase extraction column, a waste liquid bottle, a product collection bottle, a heatable labeling reaction component and the like. Compared with the traditional manual operation method, the efficient automatic synthesis of 99m Tc marked radiopharmaceuticals can be realized, the qualification rate of synthesized medicines and the repeatability of the synthesis process are ensured, and meanwhile, the occupational exposure of staff can be reduced, and the irradiated dose of the radiopharmaceuticals is reduced.
Description
Technical Field
The utility model relates to the field of synthesis of nuclear medicine radiopharmaceuticals, relates to a synthesis and purification device, and in particular relates to an automatic synthesis and purification device for 99m Tc-marked radiopharmaceuticals.
Background
The nuclear medicine functional molecular imaging technology mainly comprises two major basic stones: one is large medical instrumentation and the other is a radiotracer. The core soul of nuclear medicine functional imaging is that there are multiple targeting radiotracers, and the specificity of the targeting tracer is utilized to evaluate and examine the change of the molecular biology level in the body. For example, 99m Tc-MDP is mainly used for assessing tumor bone metastasis; 99m Tc-PSMA is mainly used for prostate tumor assessment; 18 F-FDG is mainly used for assessing sugar metabolism of tumors and the like.
The radioactive tracer is used as one of the drugs in a broad sense and is mainly used for early diagnosis of diseases. Radiotracers have the following three limitations compared to conventional chemical drug development; 1. the time limitation, medical nuclides have relatively short half-life, so that the purpose of clinical examination can be achieved, and meanwhile, the damage of radioactive radiation to patients is reduced, but the process optimization and final standardized production of the preparation of the radioactive drug bring greater challenges: to perform an effective number of thermal labelling reactions with sufficient radiation dose, the decaying effect of the radionuclide must be taken into account, which is not required for conventional chemical synthesis. 2. Space limitations, the development and production of radiopharmaceuticals must be operated in specific radiation-protected hot cells, which mainly include the production, purification of nuclides, thermal labeling, purification and quality control of radiopharmaceuticals, and such complex process operations are accomplished in limited operating space, with great operational convenience and flexibility compared to conventional chemical reactions. 3. The safety limitation is that the medical radionuclide is a double-edged sword, and the high sensitivity of the radionuclide can be utilized for patients to dynamically evaluate the early occurrence and development of diseases under the level of molecular biology, thereby improving the efficacy of disease diagnosis. But is a professional exposure for nuclear medicine chemists. Radiopharmaceuticals such as 99mTc-MDP、99mTc-PSMA、18F-FDG、18 F-NaF and the like that are currently in common use clinically are basically manufactured by combining a commercial automated synthesis module with a specific kit. Because of the specificity (uncertainty, flexibility, etc.) of the new radiopharmaceuticals development process, the whole development process is basically manually operated, which undoubtedly increases the occupational exposure of operators, and the qualification rate of the marked medicines also varies from person to person, lacks stable standards, which obviously does not conform to the standardized operation process.
Disclosure of Invention
Aiming at the specificity (uncertainty, flexibility and the like) of the development process of the novel radiopharmaceuticals at present, the whole development process is basically manually operated, so that occupational exposure of operators is definitely increased, meanwhile, the qualification rate of the marked medicines is also different from person to person, and the actual condition of lacking stable standards is overcome.
The technical scheme of the utility model is as follows: the utility model provides an automatic synthesis purification device of a radioactive drug for 99m Tc mark, the automatic synthesis purification device of a radioactive drug for 99m Tc mark includes ion elution device subassembly, heat mark heating subassembly and product purification subassembly, wherein, ion elution device subassembly left side is connected with heat mark heating subassembly with the hose, heat mark heating subassembly left side is connected with product purification subassembly with the hose, ion elution device subassembly includes syringe pump one, syringe pump one includes liquid outlet one, syringe pump one liquid outlet and one lead to nine distribution valve one's inlet an organic whole fixed connection, syringe pump one's piston is connected with the step motor slip table that has position information feedback, one lead to nine distribution valve one with the step motor that has the encoder connected, heat mark heating subassembly includes reaction tube, temperature control module, be equipped with sealed adapter on the reaction tube, the reaction tube sets up in the temperature control module, temperature control module right side connects two-position four-way valve one's 1 passageway, left side and one lead to nine distribution valve two's 3 passageways connection, product purification subassembly includes syringe pump two, syringe pump two liquid outlet and one lead to nine distribution valve one's inlet, one is connected with the step motor slip table that has position information feedback, one leads to nine distribution valve two to the step motor fixed connection;
Further, the range of the injection pump I of the ion leaching device component is 5mL-10mL, the volume flow of the liquid inlet of the through nine distribution valve I is less than 20uL, the liquid pressure-resistant range is 1.0-1.2Mpa, and the connecting channels of the through nine distribution valve I are respectively: the liquid inlet channel is connected with a liquid outlet I of the injection pump, and the 2 channels are connected with an injection water pipeline; the 3 channel is connected with an ethanol pipeline; the rest channels 1, 4, 6 and 7 are reserved; the 8 channels are connected with a physiological saline pipeline; the 9 channel is connected with the atmosphere, the 5 channel is connected with the 3 channel of the two-position four-way valve I, and the 2 channel of the two-position four-way valve II is connected with the outlet of the medical molybdenum technetium generator; the 4 channel is connected with an inlet of a medical molybdenum technetium generator;
Further, the temperature control module is composed of a plastic heating layer and an aluminum heat conduction block, wherein the plastic heating layer is coated on the outer side of the aluminum heat conduction block, and a heating groove and a temperature sensor mounting hole matched with the size of the reaction tube are formed in the aluminum heat conduction block;
Further, the range of a second injection pump of the product purification assembly is 5mL-10mL, and a first through nine distribution valve is provided with a second channel 1, a second channel 4 and a third channel 9 for standby; the 2 channel is connected with an injection bottle; 3, connecting a heat mark heating assembly through a channel; the 5 channel is connected with a solid phase extraction purification column; the 6 channel is connected with a waste liquid bottle; the 8 channels are connected with air, the top end and the bottom end of the solid-phase extraction purification column are respectively connected with a 5 channel of a nine-distribution valve II and a 1 channel of a two-position four-way valve II, a 4 channel of the two-position four-way valve II is connected with a waste liquid container, a 2 channel of the two-position four-way valve II is connected with a product collecting bottle, and a 3 channel is reserved.
The utility model has the positive effects that: the prior art has no commercialized synthesis device specially used for 99m Tc labeling, and the utility model fills the blank of the manufacturing technology of the radiopharmaceuticals;
The flow of the liquid in the device is mainly driven by a stepping motor, namely a syringe pump and a flow path switching valve, which are completely different from the design thought of a conventional radiopharmaceutical synthesis module, and the advantages are that: 1. the whole flow path system is simplified, so that the pipeline residue is reduced when the liquid is transferred; 2. compared with the conventional liquid transfer mode with compressed nitrogen as a driving force, the use of the injection pump greatly improves the precision and accuracy of liquid transfer; 3. the whole structure of the equipment is compact, and radiation protection during the production of radiopharmaceuticals is more convenient;
The heat marking heating component is particularly suitable for the heat marking process (the reaction volume is 100-400uL and the heating temperature is within 120 ℃) under the sealing state of small reaction volume, the marking yield can reach 60-70 percent, and the yield is greatly improved compared with the 20-30 percent of the manual marking 99m Tc medicine
And fourthly, the device not only realizes automatic synthesis of 99m Tc medicines, improves the stability and reproducibility of a production process, but also can reduce the subjective error probability of manual operation to the greatest extent, and simultaneously, the automatic operation also reduces the radiation dose of staff, thereby being convenient for realizing standardized production of the 99m Tc marked radiopharmaceuticals.
Drawings
FIG. 1 is a schematic diagram of the structure of a 99m Tc-labeled automated radiopharmaceutical synthesis and purification apparatus.
FIG. 2 is a schematic diagram of a two-position four-way valve with one position at 1 position.
FIG. 3 is a schematic diagram of a two-position four-way valve with two positions at 1 position.
FIG. 4 is a schematic diagram of a two-position four-way valve with one position at 2 positions.
FIG. 5 is a schematic diagram of a two-position four-way valve with two positions at 2 positions.
Description of the reference numerals: the device comprises a first B1-injection pump, a first P1-one-way nine-way distribution valve, a first V1-two-position four-way valve, a Y1-molybdenum technetium generator, a F1-reaction tube, a W1-temperature control module, a second B2-injection pump, a second P2-one-way nine-way distribution valve, a second Z1-solid phase extraction purification column and a second V2-two-position four-way valve.
Detailed Description
The technical scheme of the utility model is described in detail below with reference to the accompanying drawings.
FIG. 1 is a schematic structural diagram of a 99m Tc-labeled automated radiopharmaceutical synthesis and purification apparatus, which is used in the embodiment of the 99m Tc-labeled automated radiopharmaceutical synthesis and purification apparatus. The device mainly comprises a first injection pump B1, a first through nine distribution valves P1, a first two-position four-way valve V1, a molybdenum technetium generator Y1, a reaction tube F1, a second injection pump B2, a second through nine distribution valves P2, a solid phase extraction purification column Z1, a second two-position four-way valve V2, a waste liquid bottle, a product collecting bottle, a reaction tube F1, a temperature control module W1, a physiological saline bottle, an injection water bottle, an ethanol bottle and a sterile filter membrane.
The reaction tube F1 and the temperature control module W1 form a thermal mark heating assembly. The reaction tube F1 is a 1.5mL reaction tube F1 provided with a sealing adapter, is placed in the temperature control module W1, and is respectively connected with the two-position four-way valve V1 and the one-way nine-way distribution valve P2. The temperature control module W1 is composed of plastic heating silica gel (heating silica gel film) and an aluminum heat conduction block. The plastic heating silica gel is coated on the outer side of the aluminum heat conduction block. The aluminum heat conduction is provided with a heating groove and a temperature sensor mounting hole which are matched with the size of the reaction tube F1.
The liquid outlet of the injection pump B1 is fixedly connected with the liquid inlet of the first P1 of the first through nine distribution valve, and the liquid outlet of the injection pump B2 is fixedly connected with the liquid inlet of the second P2 of the first through nine distribution valve. The measuring range of the first injection pump B1 and the second injection pump B2 is 5mL, and the piston is controlled by a stepping motor sliding table with position information feedback, so that the accurate quantitative, directional and constant-speed transfer of liquid is realized. The first P1 and the second P2 of the first through nine distributing valves are controlled by a stepping motor with a code disc for positioning, so that switching of any channel is realized, the dead volume of a flow channel is smaller than 20uL, the liquid pressure-resistant range is 1.0-1.2Mpa, and the valve core is made of PTFE material with strong biocompatibility; the 5 channel of the one-way nine-distribution valve P1 is connected with the 3 channel of the two-position four-way valve V1; 2, connecting the channel P12 with an injection bottle; 3 channel P13 connects with the ethanol bottle; 1 channel, 4 channel, 6 channel and 7 channel for standby; the 8 channel P18 is connected with a physiological saline bottle; 9 channels P19 are connected with air; the first through nine distributing valve is standby with the 1 channel, the 4 channel and the 9 channel of the second P2; 2 channel P22 is connected with an injection bottle; 3, connecting a heat mark heating assembly through a channel; the 5 channel is connected with a solid phase extraction purification column; the 6 channel P26 is connected with a waste liquid bottle; 8 channel P28 is connected with air; the top end and the bottom end of the solid-phase extraction purification column Z1 are respectively connected with a 5 channel of a nine-way distribution valve II P2 and a 1 channel of a two-position four-way valve II V2, and a 2 channel of the two-position four-way valve I V1 is connected with an outlet of a medical molybdenum technetium generator Y1; the 4 channel is connected with an inlet of a medical molybdenum technetium generator Y1, and the 1 channel is connected with a heat marking heating component; the 2 channels of the two-position four-way valve II V2 are connected with a medical sterile filter membrane, and the other end of the filter membrane is connected with a product collecting bottle; the 4 channels are connected with the waste liquid bottle, and the 3 channels are reserved.
The automatic synthesis and purification of 99m Tc-labeled radiopharmaceuticals by the above-described synthesis apparatus comprises the following main steps:
The method comprises the steps of (1) carrying out ion leaching on 99m Tc to enable a through nine distribution valve P1 to be arranged in an 8-channel P18, pumping physiological saline into a syringe pump B1, then placing the through nine distribution valve P1 in a 5-channel, enabling a two-position four-way valve V1 to be arranged in a 1-position (refer to figure 2), establishing a 99m Tc ion leaching channel, enabling the through nine distribution valve P1 to be communicated with a medical molybdenum technetium generator Y1 through the two-position four-way valve V1, carrying out ion leaching on 99m Tc ions through the medical molybdenum technetium generator Y1 by utilizing the physiological saline in the syringe pump B1, and collecting the ions into a reaction tube F1;
(II) thermal marking
The two processes of liquid transfer and tube sealing and sealing reaction are realized through switching of a one-way nine distribution valve II P2 and a two-position four-way valve I V1 valve position;
(III) Synthesis purification
Comprising the following steps: 1. after the reaction system is diluted, adsorbing the product on a solid-phase extraction purification column Z1, and simultaneously discharging waste liquid into a waste liquid bottle; 2. flushing the solid phase extraction purification column Z1 with water for injection and air respectively, discharging waste liquid into a waste liquid bottle, and blow-drying a pipeline; 3. eluting the product from the solid phase extraction purification column Z1 by ethanol, and transferring the product to a product collecting bottle by a sterile filter membrane; 4. the product was diluted with a volume of physiological saline.
The specific automated synthesis steps are as follows:
1. preparation before synthesis
Before synthesis, the 8 channel P18 of the one-way nine-distributing valve one P1 is connected with a 50mL physiological saline bottle, the 2 channel P12 of the one-way nine-distributing valve one P1 is connected with a 100mL sterile injection water bottle, the 3 channel P13 of the one-way nine-distributing valve one P1 is connected with a 50mL 75% ethanol bottle, the 9 channel P19 of the one-way nine-distributing valve one P1 is connected with air, a drug precursor to be marked is added in a reaction tube F1, and an activation treatment is needed before the solid phase extraction purification column Z1 is used, and the method comprises the following steps: the method comprises the steps of flushing a column with 5mL of ethanol, flushing with 10mL of ultrapure water, and finally drying the column for later use, wherein the aseptic filter membrane needs to be activated before use, and the method comprises the following steps: washing the filter membrane with 5mL of ethanol, and drying for later use;
2. 99m Tc ion elution
Fig. 2 is a schematic diagram of the two-position four-way valve V1 at 1 position, fig. 3 is a schematic diagram of the two-position four-way valve V2 at 1 position, fig. 4 is a schematic diagram of the two-position four-way valve V1 at 2 position, and fig. 5 is a schematic diagram of the two-position four-way valve V2 at 2 position; placing a one-through nine-distributing valve P1 in an 8-channel P18, pumping normal saline into the injection pump, placing the one-through nine-distributing valve P1 in a 5-channel, placing a two-position four-way valve V1 in a 1-position, establishing 99m Tc ion leaching channels, enabling the one-through nine-distributing valve P1 to be communicated with a medical molybdenum technetium generator Y1 through the two-position four-way valve V1, leaching 99m Tc ions from the normal saline in the injection pump through the medical molybdenum technetium generator Y1, and collecting the ions into a reaction tube F1; 3. 99m Tc ions are coupled with the marking precursor, the temperature control module W1 is set to 105 ℃, a one-way nine-distribution valve P1 is arranged in a 1 channel, a two-position four-way valve V1 is arranged at a 2 position (shown in figure 4), a one-way nine-distribution valve P2 is arranged in a 5 channel, the whole reaction tube F1 is sealed, the heating reaction is carried out for 15min, after the marking reaction is finished, the reaction tube F1 is cooled for 3min, and finally the two-position four-way valve V1 is arranged at a 1 position (refer to figure 2);
4. Purification of the product by solid phase extraction
Firstly, diluting the cooled reaction, then passing the diluted solution through a solid phase extraction purification column Z1, then cleaning a reaction tube F1, flushing the solid phase extraction purification column Z1 to ensure that unreacted 99m Tc ions are cleaned, and finally drying the solid phase extraction purification column Z1, wherein the specific flow is as follows:
4.1 product hanging column
Switching a first through nine distribution valve II P2 to a 2 channel P22 to be connected to an injection water bottle, sucking 3mL of injection water by a second injection pump B2, switching the first through nine distribution valve II P2 to the 3 channel, completely transferring a cooled reaction system into the second injection pump II B2 for dilution, then placing the two-position four-way valve II V2 at a 1 position (see FIG. 3), switching the first through nine distribution valve II P2 to the 5 channel, and stopping a product on the solid phase extraction column after the second injection pump B2 passes through a solid phase extraction purification column Z1, wherein the liquid enters a waste liquid bottle;
4.2 washing and drying the solid phase extraction purification column Z1
The first through nine distributing valve II P2 is switched to the 2 channel and connected to the water bottle for injection, the second injection pump B2 absorbs 2mL of water for injection, then the first through nine distributing valve II P2 is switched to the 3 channel, all the water for injection is transferred to the reaction tube F1 for cleaning, then the cleaning liquid is transferred to the second injection pump B2, then the cleaning liquid passes through the solid-phase extraction purification column Z1 in a 4.1 operation mode, the operation is repeated for 2 times, and the complete transfer of the reaction liquid in the reaction tube F1 is ensured. Finally, the solid-phase extraction and purification column Z1 is required to be dried, a first through nine distribution valves P2 are switched to an 8-channel P28 and connected to air, a second injection pump B2 sucks 5mL of air, then the air passes through the solid-phase extraction and purification column Z1 in a 4.1 operation mode, the operation is repeated for 2 times, and the drying of the solid-phase extraction and purification column Z1 is ensured;
4.3 rinsing the product to product Collection bottle
Switching a one-way nine-distribution valve II P2 to a 7-channel P27 to be connected with a 75% ethanol bottle, sucking 400uL of 75% ethanol by a syringe pump II B2, switching the one-way nine-distribution valve II P2 to a 5-channel, simultaneously placing a two-position four-way valve II V2 at a 2 position (refer to FIG. 5), leaching a product from a solid-phase extraction purification column Z1 by the syringe pump II B2, performing aseptic treatment by an aseptic filter membrane, and finally transferring the product to a product collecting bottle; finally, the first through nine distribution valves P2 are switched to the 8-channel P28, the second injection pump B2 pumps 5mL of air, the operation is repeated for 2 times, and finally, the product is completely transferred into the product collecting bottle.
The utility model has the positive effects that: the prior art has no commercialized synthesis device specially used for 99m Tc labeling, and the utility model fills the blank of the manufacturing technology of the radiopharmaceuticals;
The flow of the liquid in the device is mainly driven by a stepping motor, namely a syringe pump and a flow path switching valve, which are completely different from the design thought of a conventional radiopharmaceutical synthesis module, and the advantages are that:
1. The whole flow path system is simplified, so that the pipeline residue is reduced when the liquid is transferred;
2. compared with the conventional liquid transfer mode with compressed nitrogen as a driving force, the use of the injection pump greatly improves the precision and accuracy of liquid transfer;
3. the whole structure of the equipment is compact, and radiation protection during the production of radiopharmaceuticals is more convenient;
The heat marking heating component is particularly suitable for the heat marking process (the reaction volume is 100-400uL, the heating temperature is within 120 ℃) under the sealing state of small reaction volume, the marking yield can reach 60-70%, and the yield is greatly improved compared with 20% -30% of the manual marking 99m Tc medicine;
And fourthly, the device not only realizes automatic synthesis of 99m Tc medicines, improves the stability and reproducibility of a production process, but also can reduce the subjective error probability of manual operation to the greatest extent, and simultaneously, the automatic operation also reduces the radiation dose of staff, thereby being convenient for realizing standardized production of the 99m Tc marked radiopharmaceuticals.
Claims (4)
1. An automated chemical synthesis purification apparatus for 99m Tc labeled radiopharmaceuticals, characterized in that: the automatic chemical combination purification device for the 99m Tc marked radiopharmaceuticals comprises an ion leaching device component, a heat mark heating component and a product purification component, wherein the left side of the ion leaching device component is connected with the heat mark heating component through a hose, the left side of the heat mark heating component is connected with the product purification component through a hose, the ion leaching device component comprises a first injection pump (B1), the first injection pump (B1) comprises a first liquid outlet, the first liquid outlet of the first injection pump (B1) is fixedly connected with a liquid inlet of a first through nine distribution valve (P1) in an integrated manner, a piston of the first injection pump (B1) is connected with a stepping motor sliding table with position information feedback, the first through nine distribution valve (P1) is connected with a stepping motor with an encoder, the heat mark heating component comprises a reaction tube (F1) and a temperature control module (W1), a sealing adapter is arranged on the reaction tube (F1), the reaction tube (F1) is arranged in the temperature control module (W1), the right side of the reaction tube is connected with a first two-position valve (V1) through a liquid inlet, the first left side of the reaction tube is fixedly connected with a second through nine distribution valve (P2) through a stepping motor (P2) through a position information feedback valve (P2), the first through nine distribution valve (P1) is fixedly connected with the stepping motor with the second injection pump (P2) through the position information feedback valve (P2), and the second through nine distribution valve (P2) is fixedly connected with the injection pump.
2. An automated radiopharmaceutical synthesis and purification apparatus for use in a 99m Tc-labeled radiopharmaceutical according to claim 1, wherein: the range of the injection pump I (B1) of the ion leaching device component is 5mL-10mL, the liquid inlet volume flow of the one-through nine-distributing valve I (P1) is less than 20uL, the liquid pressure-resistant range is 1.0-1.2Mpa, and the one-through nine-distributing valve I (P1) comprises several connecting channels: the liquid inlet channel is connected with a liquid outlet I of the injection pump I (B1), and the liquid outlet I and the liquid outlet 2 channel P12 are connected with an injection water pipeline; the 3 channel (P13) is connected with an ethanol pipeline; the rest channels 1, 4, 6 and 7 are reserved; the 8 channel (P18) is connected with a physiological saline pipeline; the 9 channel (P19) is connected with the atmosphere, the 5 channel is connected with the 3 channel of the two-position four-way valve I, and the 2 channel of the two-position four-way valve I is connected with the outlet of the medical molybdenum technetium generator (Y1); the 4 channel is connected with the inlet of a medical molybdenum technetium generator (Y1).
3. An automated radiopharmaceutical synthesis and purification apparatus for use in a 99m Tc-labeled radiopharmaceutical according to claim 1, wherein: the temperature control module is composed of a plastic heating layer and an aluminum heat conduction block, wherein the plastic heating layer is coated on the outer side of the aluminum heat conduction block, and a heating groove matched with the size of the reaction tube and a temperature sensor mounting hole are formed in the aluminum heat conduction block.
4. An automated radiopharmaceutical synthesis and purification apparatus for use in a 99m Tc-labeled radiopharmaceutical according to claim 1, wherein: the range of a second injection pump (B2) of the product purification assembly is 5mL-10mL, and a first through nine distribution valve (P2) is provided with 1 channel, 4 channels and 9 channels for standby; the 2 channel (P22) is connected with an injection bottle; 3, connecting a heat mark heating assembly through a channel; the 5 channel is connected with a solid phase extraction purification column (Z1); the 6 channel (P26) is connected with a waste liquid bottle; the 8 channels (P28) are connected with air, the top end and the bottom end of the solid-phase extraction purification column (Z1) are respectively connected with a5 channel of a nine-way distribution valve II (P2) and a1 channel of a two-position four-way valve II (V2), a4 channel of the two-position four-way valve II (V2) is connected with a waste liquid container (V24), a2 channel of the two-position four-way valve II (V2) is connected with a product collecting bottle (V22), and a3 channel is reserved.
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| CN202321833969.8U CN220803275U (en) | 2023-07-12 | 2023-07-12 | For use in99mTc-labeled radiopharmaceutical automatic synthesis and purification device |
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| CN202321833969.8U CN220803275U (en) | 2023-07-12 | 2023-07-12 | For use in99mTc-labeled radiopharmaceutical automatic synthesis and purification device |
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