18F-FDG preparation kit
Through the design of multi-layer structure and sealing mechanism, the problems of low space utilization and poor sealing of existing test kits are solved, and the stability of the drug during multiple 18F-FDG synthesis and transportation is achieved.
Patent Information
- Application Number
- CN202422976961.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-04
- Publication Date
- 2025-10-17
- Estimated Expiration
- 2034-12-04
AI Technical Summary
The existing test kit has a single-layer structure with low space utilization, and the storage reagent is only suitable for one 18F-FDG synthesis. In addition, there is a lack of an effective sealing structure between the box body and the top cover, which makes the reagent easy to leak.
A multi-layer test kit is designed, including upper space, middle space and lower space, and is equipped with adjustable sliding components and sealing mechanisms for classified storage of consumables and medicine bottles to improve space utilization, and the seams are sealed with a glue layer to prevent leakage of medicines.
It realizes multiple 18F-FDG synthesis, improves space utilization and sealing, ensures that the drug does not leak during transportation, and has good stability.
Smart Images

Figure CN223444102U_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The utility model relates to the field of radiopharmaceutical preparation, and concretely relates to a 18F-FDG preparation reagent box. BACKGROUND
[0002] 18F-FDG in radiopharmaceutical is a very common radioactive tracer, and its full name is 18 fluorine-fluorine deoxyglucose, and it becomes an important tool in clinical and scientific research because of its unique physiological characteristics and application in PET imaging. Synthesis 18F-FDG is a process involving ion exchange, nucleophilic reaction, intermediate adsorption, solid phase alkaline hydrolysis, column purification and a series of chemical processes. In order to reduce the quality and yield of radiopharmaceutical caused by on-site preparation of reagent, the standardized reagent box containing preset reagent formula and use steps appears.
[0003] Through the search, the patent of Chinese patent application No. 201120006579.4 discloses a reagent box for 18F-FDG synthesis production, a grid frame made of soft material is arranged in the box body, a plurality of holes are formed in the top of the grid frame, reagent bottles containing reagents required for synthesizing 18F-FDG are arranged in the holes, the reagents include K2.2.2 / potassium carbonate, acetonitrile and water, and the reagents are filled in the corresponding reagent bottles according to the actual production requirement. The reagent bottles in the reagent box can be directly connected with the production module for production when 18F-FDG is synthesized, and the containers are arranged in the grid frame made of soft material, so that the reagent box can be safely transported and stored. However, the above-mentioned patent has the following disadvantages: the above-mentioned existing reagent box has a single-layer structure, the space utilization is low, the storage reagent is only suitable for the synthesis of 18F-FDG once, and the box body and the top cover in the above-mentioned application do not have an effective sealing structure, when the internal reagent leaks, it is very easy to flow out from the gap between the two. SUMMARY
[0004] The utility model aims at: the existing reagent box has a single-layer structure, the space utilization is low, the storage reagent is only suitable for the synthesis of 18F-FDG once, and the box body and the top cover in the above-mentioned application do not have an effective sealing structure, when the internal reagent leaks, it is very easy to flow out from the gap between the two.
[0005] In order to realize the above-mentioned invention purpose, the utility model provides the following technical scheme:
[0006] A 18F-FDG preparation reagent box is provided to improve the above-mentioned problems.
[0007] The application is as follows:
[0008] The box body and the box cover are provided with sealing mechanisms at the seams thereof, the inside of the box body is divided into upper, middle and lower spaces from top to bottom;
[0009] The upper space is provided with consumables required for reaction;
[0010] The middle and lower spaces are provided with related medicine bottles and activated purification columns for synthesizing 18F-FDG;
[0011] The lower space is movably provided with a bottom pad, and the middle space is provided with placement plates movably connected to the box body through adjustable sliding assemblies, the adjustable sliding assemblies and the placement plates are provided in multiple groups, and the bottom pad and the placement plates are used for placing medicine bottles and activated purification columns;
[0012] The top and front of the box cover are provided with first and second openings, respectively;
[0013] The sealing mechanisms include first and second sealing plates provided at the two side seams of the box body and the box cover, respectively, and a third sealing plate provided at the bottom seam of the box body and the box cover, the inner sides of the first, second and third sealing plates are provided with glue layers for being bonded to the box body and the box cover, and the glue layers are connected end to end.
[0014] As a preferred technical solution of the present application, the adjustable sliding assembly includes two sliding rails, the two sliding rails are symmetrically mounted on the inner wall of the box body through a plurality of locks, a plurality of through holes matched with the locks are formed in the side wall of the box cover, a plurality of lock holes matched with the through holes are formed in the sliding rails, and plugs are movably mounted in the through holes.
[0015] As a preferred technical solution of the present application, the box cover includes a connecting plate connected to the outside of the box body, and a connecting piece made of soft material is connected to the outside of the connecting plate.
[0016] As a preferred technical solution of the present application, the inner side of the connecting piece is connected with a top plate and a side plate at one time, the top plate is used for closing the first opening, the side plate is used for closing the second opening, and a first protective pad is connected to the bottom of the top plate.
[0017] As a preferred technical solution of the present application, the placement plate includes a shell, a sliding groove matched with the sliding rail is formed in the side wall of the shell, and a partition pad is arranged in the inside of the shell.
[0018] As a preferred technical scheme of the present application, the top of the partition pad is provided with a second protective pad located inside the shell, and the top of the partition pad and the bottom pad are both provided with a plurality of uniformly distributed grooves.
[0019] Compared with the prior art, the present application has the following beneficial effects:
[0020] In the scheme of the present application:
[0021] 1. By arranging the upper space, the middle space and the lower space, the space inside the box body is reasonably distributed, so that the consumables, the medicine bottles and the purification columns are classified and stored, the space utilization rate inside the box body is improved, the storage quantity of the medicine bottles, the purification columns and the consumables is increased, so that the synthesis of 18F-FDG can be carried out multiple times, and by arranging the bottom pad and the placing disc, the medicine bottles and the purification columns can be better stored during use, and the stability during transportation is ensured.
[0022] 2. By arranging the plurality of placing discs, the adjustable sliding assembly, the first opening and the second opening, the consumables in the upper space can be quickly taken out through the first opening during use, the placing disc can be quickly taken out from the inside of the box body through the second opening by arranging the adjustable sliding assembly, and the bottom pad can also be taken out from the inside of the box body through the second opening, so that the medicine and the purification column inside the box body can be quickly taken out during synthesis.
[0023] 3. By arranging the sealing mechanism, the joint between the box body and the box cover can be sealed, the first sealing plate, the second sealing plate and the third sealing plate can be fixedly connected to the edge joint and the bottom joint of the box body and the box cover through the annular glue layer in series, so that the sealing property between the box body and the box cover is improved, and the problem that the leaked medicine in the medicine bottle in the box body flows out from the joint between the box body and the box cover is solved. BRIEF DESCRIPTION OF DRAWINGS
[0024] Figure 1 The internal structure diagram of the 18F-FDG preparation reagent kit provided by the present application is shown in the figure;
[0025] Figure 2 The box body structure diagram of the 18F-FDG preparation reagent kit provided by the present application is shown in the figure;
[0026] Figure 3 The box body internal structure diagram of the 18F-FDG preparation reagent kit provided by the present application is shown in the figure;
[0027] Figure 4 The connecting plate structure diagram of the 18F-FDG preparation reagent kit provided by the present application is shown in the figure;
[0028] Figure 5A shell structure schematic diagram of the 18F-FDG preparation kit provided in the application is shown in the figure.
[0029] Figure 6 A bottom pad structure schematic diagram of the 18F-FDG preparation kit provided in the application is shown in the figure.
[0030] Figure 7 A whole structure side view of the 18F-FDG preparation kit provided in the application is shown in the figure.
[0031] Figure 8 A first sealing plate structure schematic diagram of the 18F-FDG preparation kit provided in the application is shown in the figure.
[0032] Indicated in the figure:
[0033] 1, box body; 2, box cover; 3, bottom pad; 4, placement disc; 5, sliding rail; 6, first opening; 7, second opening; 8, through hole; 9, lock catch; 10, groove; 11, first sealing plate; 12, second sealing plate; 13, third sealing plate; 14, glue layer; 15, plug; 201, connecting plate; 202, connecting piece; 203, top plate; 204, side plate; 205, first protective pad; 401, shell; 402, separation pad; 403, second protective pad; 404, sliding groove. DETAILED DESCRIPTION
[0034] In order to make the purpose, technical scheme and advantages of the embodiments of the present application more clear, the technical scheme in the embodiments of the present application will be described clearly and completely below with reference to the drawings. Obviously, the described embodiments are part of the embodiments of the present application, rather than all the embodiments.
[0035] As Figures 1-8 shown, the present embodiment proposes an 18F-FDG preparation kit, which comprises a box body 1 and a box cover 2, and a sealing mechanism is arranged at the joint of the box body 1 and the box cover 2, and the inside of the box body 1 is divided into an upper space, a middle space and a lower space from top to bottom;
[0036] The reaction required consumables are placed in the upper space, and the consumables include reaction bottle plugs, liquid extraction extension pipelines, syringes and needle heads;
[0037] The related medicament bottles and activated purification columns for synthesizing 18F-FDG are placed in the middle space and the lower space, and through the arrangement of the upper space, the middle space and the lower space, the space inside the box body 1 is reasonably distributed, so that the consumables, the medicament bottles and the purification columns are classified and stored, the space utilization rate inside the box body 1 is improved, the storage quantity of the medicament bottles, the purification columns and the consumables is increased, and thus the synthesis of 18F-FDG can be carried out for multiple times;
[0038] The bottom pad 3 is arranged in the lower space, and the placing disc 4 is arranged in the middle space and is connected with the box body 1 through the adjustable sliding assembly. The adjustable sliding assembly and the placing disc 4 are provided in a plurality of groups. The bottom pad 3 and the placing disc 4 can be used for placing the medicine bottles and the activated purification columns. Through the arrangement of the bottom pad 3 and the placing disc 4, the medicine bottles and the purification columns can be better stored during use, and the stability during transportation is ensured.
[0039] The first opening 6 and the second opening 7 are respectively arranged on the top and the front of the box cover 2. Through the arrangement of the plurality of groups of the placing disc 4 and the adjustable sliding assembly, the first opening 6 and the second opening 7, the consumables in the upper space can be quickly taken out through the first opening 6 during use. Through the arrangement of the adjustable sliding assembly, the placing disc 4 can be quickly taken out from the inside of the box body 1 through the second opening 7, and the bottom pad 3 can also be taken out from the inside of the box body 1 through the second opening 7. The medicine and the purification column in the box body 1 can be quickly taken out during synthesis.
[0040] The sealing mechanism comprises the first sealing plate 11 and the second sealing plate 12 which are respectively arranged at the two side seams of the box body 1 and the box cover 2. The third sealing plate 13 is arranged at the bottom seam of the box body 1 and the box cover 2. The inner sides of the first sealing plate 11, the second sealing plate 12 and the third sealing plate 13 are provided with the glue layer 14 which is used for being bonded to the box body 1 and the box cover 2. The glue layer 14 is connected in a loop. The first sealing plate 11 and the second sealing plate 12 are in L shape. Through the arrangement of the sealing mechanism, the seams of the box body 1 and the box cover 2 can be sealed. During use, the first sealing plate 11, the second sealing plate 12 and the third sealing plate 13 can be bonded and fixed at the edge seams and the bottom seam of the box body 1 and the box cover 2 through the loop-shaped glue layer 14 which is connected in a loop, so that the sealing property between the box body 1 and the box cover 2 is improved. The problem that the leaked medicine in the medicine bottle in the box body 1 flows out from the seams of the box body 1 and the box cover 2 is solved.
[0041] As Figure 1 , Figure 2 and Figure 3As shown, as a preferred embodiment, on the basis of the above mode, further, the adjustable sliding assembly comprises two sliding rails 5, which are symmetrically installed on the inner wall of the box body 1 through a plurality of buckles 9, a plurality of rows of through holes 8 matched with the buckles 9 are formed on the side wall of the box cover 2, lock holes matched with the through holes 8 are formed on the sliding rails 5, and plugs 15 are movably installed in the through holes 8. Through the arrangement of the plurality of rows of through holes 8, the height position of the sliding rail 5 can be adjusted through the through holes 8 and the lock holes on the sliding rail 5, so that the height of the placement disc 4 can be flexibly adjusted, the cooperation between the plurality of groups of placement discs 4 is facilitated, and the bottommost placement disc 4 can also be prevented from colliding with the medicine bottles or purification columns in the bottom pad 3 during sliding. Through the arrangement of the plugs 15, the unused through holes 8 can be closed to prevent the leaked medicine in the box body 1 from flowing out.
[0042] As shown in Figure 1 and Figure 4 As a preferred embodiment, on the basis of the above mode, further, the box cover 2 comprises a connecting plate 201 connected to the outside of the box body 1, a connecting piece 202 made of soft material is connected to the outside of the connecting plate 201, a top plate 203 and a side plate 204 are connected to the inside of the connecting piece 202, the top plate 203 is used to close the first opening 6, the side plate 204 is used to close the second opening 7, a first protective pad 205 is connected to the bottom of the top plate 203, the connecting plate 201 is fixedly installed on the outside of the box body 1 during use, the soft connecting piece 202 can facilitate the opening and closing of the top plate 203 and the side plate 204, so as to facilitate the closing of the first opening 6 and the second opening 7, and through the arrangement of the first protective pad 205, the consumables in the upper space of the box body 1 can be extruded and fixed when the top plate 203 covers the top of the box body 1, so as to prevent the consumables in the upper space of the reagent box from moving during transportation. After the medicine bottles, purification columns and consumables in the inside of the box body 1 and the box cover 2 are loaded, a heat-shrinkable sealing film can be wrapped to close them, so as to prevent the items in the box body 1 from falling during transportation.
[0043] As shown in Figure 5 and Figure 6As shown, as a preferred embodiment, on the basis of the above-mentioned mode, further, the placing disc 4 comprises a shell 401, a sliding groove 404 is formed in the side wall of the shell 401 and matched with the sliding rail 5, a partition pad 402 is arranged in the shell 401, a second protection pad 403 is arranged on the top of the partition pad 402 and located in the inside of the shell 401, a plurality of recesses 10 are formed in the top of the partition pad 402 and the bottom pad 3 and uniformly distributed, the placing disc 4 can be conveniently pulled out or pushed into the inside of the box body 1 through the sliding rail 5 by the arrangement of the recesses 10, the shell 401 can facilitate the installation of the partition pad 402, and the second protection pad 403 can cover the top of the objects in the partition pad 402 during use, so that the objects are more comprehensively protected by the partition pad 402.
[0044] As shown in Figure 1 , Figure 2 , Figure 4 , Figure 5 and Figure 6 , as a preferred embodiment, on the basis of the above-mentioned mode, further, the bottom pad 3, the first protection pad 205, the partition pad 402 and the second protection pad 403 are all made of PU foamed sponge material, so that the reagent bottle, the purification column and the consumables can be better fixed and protected during use, and the stability during transportation is ensured.
[0045] Specifically, during use of the 18F-FDG preparation kit, the reagent bottle and the purification column are first arranged in the recesses 10 on the bottom pad 3 and the placing disc 4 respectively, then the bottom pad 3 is pushed into the lower space in the inside of the box body 1, the lock buckle 9 is unscrewed when the height of the placing disc 4 needs to be adjusted, then the position of the sliding rail 5 is moved, the lock hole on the sliding rail 5 is matched with the through hole 8 on the box body 1 when the sliding rail 5 is moved to the required height position, then the lock buckle 9 is screwed through the through hole 8 and into the lock hole on the sliding rail 5, so that the height of the sliding rail 5 is adjusted, and the unused through hole 8 is plugged by the plug 15 after adjustment, at this time, the placing disc 4 can be pushed into the inside of the box body 1 through the recesses 10 and the sliding rail 5, and the related consumables can be arranged in the upper space in the inside of the box body 1 after the placing disc 4 is installed, the consumables in the upper space in the inside of the box body 1 are fixed by the first protection pad 205 after filling, so that the consumables are prevented from moving during transportation, then the first sealing plate 11, the second sealing plate 12 and the third sealing plate 13 are arranged at the joint between the box body 1 and the box cover 2 through the glue layer 14, and finally the box body 1 and the box cover 2 are wrapped with the heat-shrinkable sealing film and fixed, so that they are closed and fixed.
[0046] The utility model is used for 18F-FDG preparation synthesis, a typical embodiment is that three layers of bottom are arranged in the inside 18F-FDG related vial reagent and product bottle; middle layer placed two sets of activated C18 column sleeve, a set of activated purification column sleeve; activated in advance using automatic equipment (reduce manual activation error), on-site disassembly and installation to the corresponding automatic equipment corresponding position can be used. The upper space is placed reaction tube and reaction bottle plug, liquid extraction extension pipeline, syringe, needle, QMA column and other consumables.
[0047] In each reagent bottle in the upper layer, one specific embodiment is that the eluent is 7.5ml, calculated as 1.5ml per single use, enough for four uses; the acetonitrile for dissolving precursor (trifluoromannose) is 6ml, calculated as 1.2ml per single use, enough for four uses; the NaOH solution is 7ml, calculated as 1.5ml per single use, enough for four uses.
[0048] The reagent kit follows the principle of "one replacement, four uses", so the acetonitrile for synthesis is 50ml, including 8ml acetonitrile for four synthesis of FDG, and 32ml acetonitrile required for reaction tube cleaning during the four interval cleaning programs combined with the pipeline cleaning program of the automatic equipment. In order to ensure the cleanliness of the synthesis pipeline, the reagent kit has a special cleaning acetonitrile of 50ml, which is used for pipeline cleaning combined with the pipeline cleaning program of the automatic equipment. The bottom layer of the reagent kit also has a round bottom reaction tube made of high borosilicate material and a silica gel plug matched therewith. The plug has three holes connected to the pipelines, which play different roles. Two small diameter pipelines correspond to the liquid inlet and liquid outlet pipeline, and one large diameter pipeline corresponds to the exhaust pipeline. This reaction tube and its matched plug are one box for four syntheses, which can be replaced after four syntheses, reducing the impact factors of nucleophilic reaction due to the continuous use of the reaction bottle. There are also additional multiple reagent liquid extraction extension pipelines provided, which are convenient for connecting the vial and the automatic equipment, and still replace every four times, reducing pollution caused by multiple uses.
[0049] The above examples are only used to illustrate the technical solutions described in the present application and do not limit the technical solutions described in the present application. Although the present application has been described in detail with reference to the above embodiments, the present application is not limited to the above specific embodiments, therefore any modification or equivalent replacement of the present application; all technical solutions and improvements within the spirit and scope of the invention are covered in the scope of the claims of the present application.
Claims
1. A 18F-FDG preparation kit, comprising a box body (1) and a box cover (2), characterized in that: A sealing mechanism is provided at the joint between the box body (1) and the box cover (2), and the interior of the box body (1) is divided from top to bottom into an upper space, a middle space, and a lower space; Consumables required for the reaction are placed in the upper space; Related pharmaceutical bottles and activated purification columns for synthesizing 18F-FDG are placed in the middle space and the lower space; A bottom pad (3) is movably installed in the lower space, and a placement tray (4) is installed in the middle space, which is slidably connected to the box body (1) through an adjustable sliding component. The adjustable sliding component and the placement tray (4) are provided in several groups. Both the bottom pad (3) and the placement tray (4) can be used to place medicine bottles and activated purification columns: The top and front of the box cover (2) are respectively provided with a first opening (6) and a second opening (7); The sealing mechanism comprises a first sealing plate (11) and a second sealing plate (12) respectively arranged at two side seams of the box body (1) and the box cover (2); a third sealing plate (13) is arranged at the bottom seam of the box body (1) and the box cover (2); and the inner sides of the first sealing plate (11), the second sealing plate (12) and the third sealing plate (13) are all provided with a glue layer (14) for bonding to the box body (1) and the box cover (2), and the glue layers (14) are connected end to end.
2. A 18F-FDG preparation kit according to claim 1, characterized in that, The adjustable sliding assembly includes two sliding rails (5), the two sliding rails (5) are symmetrically mounted on the inner wall of the box body (1) through a plurality of lock buckles (9), the side wall of the box cover (2) is provided with a plurality of rows of through holes (8) that cooperate with the lock buckles (9), the sliding rails (5) are provided with lock holes that cooperate with the through holes (8), and a plug (15) is movably mounted in the through hole (8).
3. A 18F-FDG preparation kit according to claim 1, characterized in that, The box cover (2) comprises a connecting plate (201) connected to the outside of the box body (1), and a connecting piece (202) made of a soft material is connected to the outside of the connecting plate (201).
4. A 18F-FDG preparation kit according to claim 3, characterized in that, The inner side of the connecting piece (202) is connected to a top plate (203) and a side plate (204), the top plate (203) is used to close the first opening (6), the side plate (204) is used to close the second opening (7), and the bottom of the top plate (203) is connected to a first protective pad (205).
5. A 18F-FDG preparation kit according to claim 2, characterized in that, The placement tray (4) comprises a shell (401), a sliding groove (404) cooperating with the sliding track (5) is provided on the side wall of the shell (401), and a separation pad (402) is provided inside the shell (401).
6. A 18F-FDG preparation kit according to claim 5, characterized in that, A second protective pad (403) located inside the shell (401) is provided on the top of the separation pad (402), and a plurality of evenly distributed grooves (10) are provided on the tops of both the separation pad (402) and the bottom pad (3).
Citation Information
Patent Citations
Kit for synthesizing 18F-FDG (Fluorine-Fludeoxyglucose)
CN201981144U