CN113813183A - Automatic synthesis device for radioactive labeling microspheres and use method - Google Patents
Automatic synthesis device for radioactive labeling microspheres and use method Download PDFInfo
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- CN113813183A CN113813183A CN202111164819.8A CN202111164819A CN113813183A CN 113813183 A CN113813183 A CN 113813183A CN 202111164819 A CN202111164819 A CN 202111164819A CN 113813183 A CN113813183 A CN 113813183A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K51/00—Preparations containing radioactive substances for use in therapy or testing in vivo
- A61K51/02—Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
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Abstract
An automatic synthesis device for radioactive labeling microspheres comprises a radionuclide solution bottle, a buffer solution bottle, a physiological saline bottle, a microsphere solution bottle, an injector, a radioactive microsphere solution bottle, a PBS bottle and a waste liquid bottle which are sequentially communicated with a main pipeline; and are communicated with the main pipeline through connecting pieces respectively. The invention adopts an automatic synthesis one-step method to prepare the radioactive silicon dioxide microspheres; the full automation is realized; the repeatability of radioactive microspheres is good, and the quality is controllable; fully automated marking reduces the exposure dose to the operator.
Description
Technical Field
The invention relates to the technical field of medical equipment, in particular to an automatic synthesis device for radioactive labeling microspheres and a using method thereof.
Background
Liver cancer is an important reason threatening human health, and surgical treatment, chemotherapy and radiotherapy are the main methods for treating liver cancer at present. Surgical therapy is only applicable to early stage liver cancer and requires patients to be resistant to surgery. While the selectivity of chemotherapy drugs is poor, side effects of different degrees often appear while the treatment result is obtained, and the tumor is possibly not sensitive to the chemotherapy drugs any more after multiple times of chemotherapy. External irradiation treatments can damage normal tissues and limit the dose irradiated. Internal radiation therapy (also called interventional radiotherapy) is an effective means for treating liver cancer, and radioactive nuclides are enriched at a tumor part by using a carrier, so that a tumor region can obtain higher absorbed dose, and the dose of irradiated normal liver tissues is very small. The radioactive microsphere interventional embolization treatment of liver cancer has the dual effects of vascular embolization and radiotherapy.
It is important how radioactive microspheres can be automated during the preparation process. The automatic synthesis can help the staff to reduce radiation irradiation, and the preparation quality is controllable.
At present, most of the imaging agents utilize commercial full-automatic synthesizers (such as Tracer LabFXF F-N series of the United states general electric company (medical system); Syn Chrom R & D of Raytest company in Germany; and fluorine multifunctional synthesis module PETMF-2V-IV-I of Peking Pat company), and the like, and the commercial machines have respective defects, such as that common users cannot modify the reaction process, the synthesizers only aim at the synthesis of one or more small molecular drugs, most aim at the labeling of positron small molecular drugs 18F and the like, and foreign import equipment is expensive.
Therefore, it is one of the technical problems to be solved in the art to provide an automated synthesis apparatus and process for radiolabeling microspheres, which have good repeatability and controllable quality of radioactive microsphere preparation, reduce the irradiation dose to the operator by full-automatic labeling, and realize automation.
Disclosure of Invention
In view of the above, the present invention is an automated process for preparing radioactive silica microspheres by an automated synthesis one-step method, and automatically separating the radioactive silica microspheres into labeled radionuclides by adsorbing or precipitating the radionuclides into the silica microspheres, thereby obtaining radionuclide-labeled microspheres. The labeling efficiency of the obtained radioactive microspheres can reach 97 +/-3%. Can be used for the radioembolization treatment of tumors such as liver cancer.
In order to solve the technical problems, the invention adopts the following technical scheme:
an automatic synthesis device for radioactive labeling microspheres comprises a radionuclide solution bottle, a buffer solution bottle, a physiological saline bottle, a microsphere solution bottle, an injector, a radioactive microsphere solution bottle, a PBS bottle and a waste liquid bottle which are sequentially communicated with a main pipeline; and are communicated with the main pipeline through connecting pieces respectively.
Preferably, the filter screen is communicated with the main pipeline through two connecting pieces.
Preferably, the connecting piece comprises a tee 1 ', a tee 2', a tee 3 ', a tee 4', a tee 5 ', a tee 6', a tee 7 'and a tee 8'.
The invention also provides a using method of the automatic synthesis device for the radioactive labeling microspheres, which comprises the following steps:
1) placing the microsphere solution bottle filled with the silicon dioxide microsphere aqueous solution on a constant-temperature mixing instrument for slight shaking and mixing, then rotating the tee joint 1 ', the tee joint 2', the tee joint 3 'and the tee joint 4' to communicate the radionuclide solution bottle with the injector, and absorbing the radionuclide solution in the radionuclide solution bottle by using the injector;
2) rotating a tee joint 3 'and a tee joint 4' to communicate the microsphere solution bottle and the injector, slowly adding the radionuclide in the injector into the microsphere solution bottle, and then oscillating the solution in a constant-temperature mixing instrument for 5 to 10 minutes to prepare a silicon dioxide microsphere mixture;
3) rotating the tee joint 1 ', the tee joint 2' and the tee joint 3 ', extracting a buffer solution in the buffer solution bottle by using the injector, then rotating the tee joint 3' to connect the microsphere solution bottle and the injector, slowly adding the buffer solution into the microsphere solution bottle, continuing to vibrate for 10-30 minutes, and then sucking out the microsphere solution in the microsphere solution bottle by using the injector;
4) rotating a tee joint 4 ', a tee joint 5 ', a tee joint 6 ', a tee joint 7 ' and a tee joint 8 ', communicating the injector, the filter screen and the waste liquid bottle, and discharging the microsphere solution in the injector;
5) the three-way valve 2 'and the three-way valve 4' are rotated to connect the injector and the physiological saline bottle, and the injector is used for extracting the physiological saline in the physiological saline bottle; rotating the tee joint 4', connecting the injector 9, the filter screen 8 and the waste liquid bottle 7, extruding physiological saline, and washing the radioactive nuclide which is not marked on the microspheres in the microsphere solution;
6) a rotary tee joint 8' is connected with the syringe and a radioactive microsphere solution bottle, and the radioactive microspheres on the filter screen are sucked into the syringe; and (5) rotating the tee joint 5', the syringe and the radioactive microsphere solution bottle, and injecting radioactive microspheres into the radioactive microsphere solution bottle to obtain a final product.
Preferably, the microspheres are one or more of porous silica microspheres (20 μm to 100 μm) and porous resin microspheres (20 μm to 100 μm).
Preferably, the filter membrane size of the filter screen is smaller than the size of the microspheres.
Preferably, the filter membrane size of the filter screen is 1 μm to 20 μm.
Preferably, the radionuclide is lutetium-177 (lutetium177Lu), yttrium-90: (90Y), actinium-225 (225Ac) one or more of the metallic radionuclides.
Preferably, the temperature of the constant-temperature oscillator is 100 +/-1 ℃; the amplitude is 0mm-20 mm.
Compared with the prior art, the invention has the following technical effects:
(1) the invention adopts an automatic synthesis one-step method to prepare the radioactive silicon dioxide microspheres;
(2) the invention realizes full automation;
(3) the repeatability of radioactive microspheres is good, and the quality is controllable;
(4) fully automated marking reduces the exposure dose to the operator.
Drawings
FIG. 1 is a schematic structural diagram of an automated synthesizer for radiolabelled microspheres according to the present invention.
In the figure: 1. a radionuclide bottle; 2. a buffer liquid bottle; 3. a physiological saline bottle; 4. a microsphere solution bottle; 5. a radioactive microspherical vial; 6. PBS bottle; 7. a waste liquid bottle; 8. filtering with a screen; 9. an injector; 1 'to 8': and a tee joint.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
Referring to fig. 1, an automatic synthesizer for radioactive labeled microspheres includes a radionuclide solution bottle 1, a buffer solution bottle 2, a physiological saline bottle 3, a microsphere solution bottle 4, a syringe 9, a radioactive microsphere solution bottle 5, a filter screen 8, a PBS bottle 6 and a waste solution bottle 7 which are sequentially communicated with a main pipeline; and are respectively communicated with the main pipeline through a connecting piece; the filter screen 2 is communicated with the main pipeline through two connecting pieces.
In this embodiment, the connecting member includes a tee 1 ', a tee 2', a tee 3 ', a tee 4', a tee 5 ', a tee 6', a tee 7 'and a tee 8'.
In this embodiment, a method for using an automated synthesis apparatus for radiolabelled microspheres includes the following steps:
1) placing the microsphere solution bottle 4 filled with the silicon dioxide microsphere aqueous solution on a constant-temperature mixing instrument for slight shaking and mixing, then rotating the tee joint 1 ', the tee joint 2', the tee joint 3 ', the tee joint 4', communicating the radionuclide solution bottle 1 with the syringe 9, and sucking the radionuclide solution in the radionuclide solution bottle 1 by using the syringe 9;
2) rotating the tee joint 3 'and the tee joint 4', communicating the microsphere solution bottle 4 with the injector 9, slowly adding the radionuclide in the injector 9 into the microsphere solution bottle 4, and then oscillating in a constant-temperature mixing instrument for 5-10 minutes to prepare a silicon dioxide microsphere mixture;
3) rotating the tee joint 1 ', the tee joint 2' and the tee joint 3 ', extracting a buffer solution in the buffer solution bottle 2 by using the injector 9, then rotating the tee joint 3' to connect the microsphere solution bottle 4 and the injector 9, slowly adding the buffer solution into the microsphere solution bottle 4, continuing to vibrate for 10-30 minutes, and then sucking out the microsphere solution in the microsphere solution bottle 4 by using the injector 9;
4) rotating the tee joint 4 ', the tee joint 5 ', the tee joint 6 ', the tee joint 7 ' and the tee joint 8 ', communicating the injector 9, the filter screen 8 and the waste liquid bottle 7, and discharging the microsphere solution in the injector 9;
5) the three-way valve 2 'and the three-way valve 4' are rotated to connect the injector 9 and the physiological saline bottle 3, and the injector 9 is used for extracting the physiological saline in the physiological saline bottle 3; rotating the tee joint 4', extruding physiological saline, and washing the radioactive nuclide which is not marked on the microspheres in the microsphere solution;
6) rotating the tee joint 8', connecting the syringe 9 with the radioactive microsphere solution bottle 5, and sucking the radioactive microspheres on the filter screen 8 into the syringe 9; and (3) rotating the tee joint 5', the syringe 9 and the radioactive microsphere solution bottle 5, and injecting radioactive microspheres into the radioactive microsphere solution bottle 5 to obtain a final product.
In some embodiments, the microspheres are one or more of porous silica microspheres (20 μm to 100 μm) and porous resin microspheres (20 μm to 100 μm).
In some embodiments, the filter mesh 8 has a filter membrane size that is smaller than the size of the microspheres.
In some embodiments, the filter mesh 8 has a filter membrane size of 1 μm to 20 μm.
In some embodiments, the radionuclide is lutetium-177 (lutetium:, the radionuclide177Lu), yttrium-90: (90Y), actinium-225 (225Ac) one or more of the metallic radionuclides.
In some embodiments, the temperature of the constant temperature shaker is 100 ± 1 ℃ at room temperature; the amplitude is 0mm-20 mm.
Example 2
An experimental instrument: one-ten-thousandth balance (ME204, mettler-toledo shanghai ltd); radioactivity meter (FJ-391A4, Beijing Nuclear instruments Co., Ltd.); gamma radioimmunoassay (LB2111, BERTHOLD, Germany).
Experimental reagent: silica microspheres (Suzhou knoyi microspheres technologies, Inc.);177LuCl3solution (china co-radial limited); hydrogenPotassium oxide (Shanghai Aladdin Biotechnology Ltd.); phosphoric acid (Shanghai Aladdin Biotechnology Ltd.);
the experimental steps are as follows:
1) placing a microsphere solution bottle 4 containing 0.5mL of aqueous solution to be marked containing 1mg of silicon dioxide microspheres on a constant-temperature mixing instrument, and slightly shaking and mixing uniformly; then the tee joint 1 ', the tee joint 2', the tee joint 3 ', the tee joint 4' are rotated to communicate the radionuclide solution bottle 1 with the injector 9; a syringe 9 is used for sucking the radionuclide solution (50 muL, 10mCi) in the radionuclide solution bottle 1;
2) rotating the tee joint 3 'and the tee joint 4', communicating the microsphere solution bottle 4 with the injector 9, slowly adding the radioactive nuclide in the injector 9 into the microsphere solution bottle 4, uniformly mixing at room temperature, and shaking for 5 minutes to obtain a silicon dioxide microsphere mixture;
3) rotating the tee joint 1 ', the tee joint 2' and the tee joint 3 ', communicating the injector 9 with the buffer solution bottle 2, extracting a buffer solution (0.1mL) in the buffer solution bottle 2 by using the injector 9, then rotating the tee joint 3' to connect the microsphere solution bottle 4 with the injector 9, slowly metering the buffer solution into the microsphere solution bottle 4, continuing to vibrate for 10 minutes, and then sucking out the microsphere solution in the microsphere solution bottle 4 by using the injector 9;
4) rotating the tee joint 4 ', the tee joint 5 ', the tee joint 6 ', the tee joint 7 ' and the tee joint 8 ', communicating the injector 9, the filter screen 8(10 mu m) and the waste liquid bottle 7, and discharging the microsphere solution in the injector 9;
5) the three-way valve 2 'and the three-way valve 4' are rotated to connect the injector 9 and the physiological saline bottle 3, and the injector 9 is used for extracting the physiological saline (2mL) in the physiological saline bottle 3; rotating the tee joint 4', connecting the injector 9, the filter screen 8 and the waste liquid bottle 7, extruding physiological saline, and washing the radioactive nuclide which is not marked on the microspheres in the microsphere solution;
6) rotating the tee joint 8', connecting the syringe 9 with the radioactive microsphere solution bottle 5, and sucking the radioactive microspheres on the filter screen 8 into the syringe 9; and (3) rotating the tee joint 5', the syringe 9 and the radioactive microsphere solution bottle 5, and injecting radioactive microspheres into the radioactive microsphere solution bottle 5 to obtain a final product.
Finally, the marking efficiency of the measurement is measured to be as high as 98% + -2%.
Compared with the prior art, the invention has the advantages that: the invention adopts an automatic synthesis one-step method to prepare the radioactive silicon dioxide microspheres; the invention realizes full automation; the repeatability of radioactive microspheres is good, and the quality is controllable; fully automated marking reduces the exposure dose to the operator.
The above description is only a preferred embodiment of the present invention, and is not intended to limit the technical scope of the present invention, so that any minor modifications, equivalent changes and modifications made to the above embodiment according to the technical spirit of the present invention are within the technical scope of the present invention.
Claims (9)
1. An automatic synthesis device for radioactive labeling microspheres is characterized by comprising a radionuclide solution bottle (1), a buffer solution bottle (2), a physiological saline bottle (3), a microsphere solution bottle (4), an injector (9), a radioactive microsphere solution bottle (5), a PBS bottle (6) and a waste liquid bottle (7) which are sequentially communicated with a main pipeline; and are communicated with the main pipeline through connecting pieces respectively.
2. An automated synthesis apparatus for radiolabelled microspheres according to claim 1, characterized by further comprising a sieve (8), said sieve (8) being in communication with said main conduit through two connections.
3. The automated synthesizer for radiolabelled microspheres according to claim 1, wherein the linker comprises a tee 1 ', a tee 2', a tee 3 ', a tee 4', a tee 5 ', a tee 6', a tee 7 'and a tee 8'.
4. A method of using an automated synthesis apparatus for radiolabeling microspheres comprising the steps of:
1) placing the microsphere solution bottle (4) filled with the silicon dioxide microsphere aqueous solution on a constant-temperature mixing instrument for slight shaking and mixing, then rotating the tee joint 1 ', the tee joint 2', the tee joint 3 ', the tee joint 4' to communicate the radionuclide solution bottle (1) and the injector (9), and absorbing the radionuclide solution in the radionuclide solution bottle (1) by using the injector (9);
2) rotating the tee joint 3 'and the tee joint 4' to communicate the microsphere solution bottle (4) with the injector (9), slowly adding the radioactive nuclide in the injector (9) into the microsphere solution bottle (4), and then oscillating for 5-10 minutes in a constant-temperature mixing instrument to prepare a silicon dioxide microsphere mixture;
3) rotating the tee joint 1 ', the tee joint 2' and the tee joint 3 ', extracting a buffer solution in the buffer solution bottle (2) by using the syringe (9), then rotating the tee joint 3' to connect the microsphere solution bottle (4) with the syringe (9), slowly adding the buffer solution into the microsphere solution bottle (4), continuing to vibrate for 10-30 minutes, and then sucking out the microsphere solution in the microsphere solution bottle (4) by using the syringe (9);
4) rotating a tee joint 4 ', a tee joint 5 ', a tee joint 6 ', a tee joint 7 ' and a tee joint 8 ', communicating the injector (9), the filter screen (8) and the waste liquid bottle (7), and discharging the microsphere solution in the injector (9);
5) the three-way valve 2 'and the three-way valve 4' are rotated to connect the injector (9) and the physiological saline bottle (3), and the injector (9) is used for extracting the physiological saline in the physiological saline bottle (3); rotating a tee joint 4', connecting the injector 9, the filter screen 8 and the waste liquid bottle 7, extruding physiological saline, and washing the microspheres in the microsphere solution without labeled radionuclides;
6) a rotary tee joint 8' is connected with the syringe (9) and a radioactive microsphere solution bottle (5) to suck radioactive microspheres on the filter screen (8) into the syringe (9); and (3) rotating the tee joint 5', the injector (9) and the radioactive microsphere solution bottle (5), and injecting radioactive microspheres into the radioactive microsphere solution bottle (5) to obtain a final product.
5. Use of an automated synthesis apparatus for radiolabelled microspheres according to claim 4, wherein the microspheres are one or more of porous silica microspheres (20 μm-100 μm) and porous resin microspheres (20 μm-100 μm).
6. Use of an automated synthesis unit for radiolabelled microspheres according to claim 4, characterised in that the filter mesh (8) has a filter membrane size smaller than the size of the microspheres.
7. The use of an automated synthesis apparatus for radiolabelled microspheres according to claim 6, wherein the filter mesh (8) has a filter size comprised between 1 μm and 20 μm.
8. The method of claim 4, wherein said radionuclide is lutetium-177 (lutetium-177)177Lu), yttrium-90: (90Y), an actinium-225 (225Ac) metal radionuclide.
9. The use method of the automatic synthesizer for radioactive labeled microspheres according to claim 4, wherein the temperature of the constant temperature oscillator is 100 ± 1 ℃ at room temperature; the amplitude is 0mm-20 mm.
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Cited By (1)
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