Method for cleaning and separating radioactive yttrium-90 glass microspheres

Abstract

The application provides a method for cleaning and separating radioactive yttrium-90 glass microspheres, comprising the following operations: cleaning yttrium-90 glass microspheres with a cesium acetate aqueous solution; filtering and separating the cleaned yttrium-90 glass microspheres; and drying the filtered and separated yttrium-90 glass microspheres. Through the method, the yttrium-90 glass microspheres can be effectively cleaned, and the purity and safety of the yttrium-90 glass microspheres are improved.

Description

Technical Field

[0001] This invention relates to the technical field of radioactive glass microspheres, and more particularly to a method for cleaning and separating radioactive yttrium-90 glass microspheres. Background Technology

[0002] Microsphere radioembolization therapy is a targeted tumor radiotherapy technique widely used in selective internal radiotherapy (SIRT) for malignant tumors such as the liver. It involves delivering a targeted, high-dose, high-energy beta radiation to the lesion to kill cancer cells while effectively protecting healthy tissues and organs. Currently, commercially available microsphere products include... 90 Y-resin microspheres and glass microspheres have been included in several authoritative liver cancer diagnosis and treatment guidelines and standards.

[0003] To ensure the safety of yttrium-90 glass microspheres, the microspheres and yttrium-90 must be firmly bonded, meaning the free yttrium-90 (leaking rate) must not exceed medical requirements. Therefore, leaching rate testing is necessary for yttrium-90 glass microspheres, requiring cleaning and separation procedures. Existing methods for cleaning and separating radioactive yttrium-90 glass microspheres suffer from poor cleaning effectiveness and are prone to nuclear contamination. Therefore, there is an urgent need to develop new methods for cleaning and separating yttrium-90 glass microspheres to address these issues. Summary of the Invention

[0004] In view of this, the main objective of the present invention is to provide a method for cleaning and separating radioactive yttrium-90 glass microspheres, which can effectively clean yttrium-90 glass microspheres, reduce nuclear contamination during operation, and improve operational safety.

[0005] To achieve the above objectives, this invention provides a method for cleaning and separating radioactive yttrium-90 glass microspheres. This method includes the following operations:

[0006] Yttrium-90 glass microspheres were cleaned with a cesium acetate aqueous solution.

[0007] Filtration and separation of washed yttrium-90 glass microspheres; and

[0008] Dry the filtered and separated yttrium-90 glass microspheres.

[0009] In some embodiments, the method further includes preparing an aqueous solution of cesium acetate. In some embodiments, the method further includes preparing an aqueous solution of cesium acetate with a density of 1.5 g / mL to 3 g / mL. In one specific embodiment, an aqueous solution of cesium acetate with a density of 2 g / mL is prepared.

[0010] In some embodiments, the mass ratio of the cesium acetate aqueous solution to the yttrium-90 glass microspheres is from 2:1 to 40:1. In one specific embodiment, the mass ratio of the cesium acetate aqueous solution to the yttrium-90 glass microspheres is 20:1.

[0011] In some embodiments, during the cleaning process, an aqueous solution of cesium acetate is placed in a container, the opening of the container is then sealed, and yttrium-90 glass microspheres are introduced.

[0012] In some implementations, the cleaning process involves first performing vibration cleaning and then ultrasonic cleaning, with the vibration cleaning being repeated 2 to 4 times.

[0013] In some embodiments, floating and suspended yttrium-90 glass microspheres are removed after each vibration wash. Furthermore, the interval between vibration washes is 0.5 hours to 1 hour.

[0014] In some embodiments, ultrasonic cleaning is performed for 10 to 15 minutes at a power of 20 Hz to 45 Hz and a temperature of 30°C to 40°C. Further, ultrasonic cleaning is repeated 2 to 3 times, with the yttrium-90 glass microspheres soaked in 37°C physiological saline between ultrasonic cleaning cycles, followed by continued ultrasonic cleaning with deionized water.

[0015] In some implementations, filtration is performed using glass fiber filter paper. Furthermore, the filtration process is repeated 3 to 6 times.

[0016] In some embodiments, drying is carried out at a temperature of 60°C to 80°C for 240 to 300 minutes.

[0017] In some embodiments, the method of this application further includes cleaning the equipment, wherein the equipment includes the container and instruments used in the method.

[0018] Furthermore, the present invention also relates to the use of radioactive yttrium-90 glass microspheres provided by the method of the present invention in the preparation of drugs for treating tumors. Attached Figure Description

[0019] Figure 1 This is a flowchart illustrating an embodiment of the cleaning and separation method of this application.

[0020] Figure 2 This is a flowchart of another embodiment of the cleaning and separation method of this application.

[0021] Figure 3 The vibration cleaning operation of this application is shown.

[0022] Figure 4 The filtering operation of this application is shown.

[0023] Figure 5 Microscopic images of yttrium-90 glass microspheres before cleaning are shown.

[0024] Figure 6 Microscopic images of yttrium-90 glass microspheres after cleaning and separation according to the method of this application are shown. Detailed Implementation

[0025] The following detailed description of exemplary embodiments, taken in conjunction with the accompanying drawings, illustrates these embodiments. The specific embodiments included herein should not be construed as limiting the invention. Furthermore, while specific language may be used to describe features, actions, and / or structures in the embodiments described herein, the claims are not limited to the described features, actions, and / or structures. Those skilled in the art will understand that other embodiments, including improvements, are within the spirit and scope of the invention.

[0026] Throughout this specification, unless otherwise specified, the terminology used herein should be understood as having the meaning as commonly used in the art. Therefore, unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0027] Yttrium-90 glass microspheres refer to glass microspheres loaded with yttrium-90, and are currently mainly used for the treatment of liver cancer. Therefore, their binding strength, cleanliness, and density affect their therapeutic efficacy and safety.

[0028] Reference Figure 1 The method of this application includes:

[0029] S1: Clean yttrium-90 glass microspheres with cesium acetate aqueous solution;

[0030] S2: Filtration and separation of cleaned yttrium-90 glass microspheres; and

[0031] S3: Dry the filtered and separated yttrium-90 glass microspheres.

[0032] In this application, yttrium-90 glass microspheres are cleaned with a cesium acetate aqueous solution. Cesium acetate is stable at room temperature and pressure. When cesium acetate absorbs sufficient water, the carboxyl group in the acetate ion undergoes a hydrolysis reaction, generating acetate and cesium ions, thus causing cesium acetate to deliquesce. At room temperature, the solubility of cesium acetate in 100 mL of water is 945 g, and at 89°C, its solubility in 100 mL of water reaches 1346 g. Furthermore, its molecular structure contains acetate ions, which possess certain nucleophilic properties, enabling effective surface cleaning of radioactive yttrium-90 glass microspheres, removing adhering floating matter and ensuring the purity of the yttrium-90 glass microspheres.

[0033] In this application, cesium acetate aqueous solutions with densities ranging from 1.5 g / mL to 3 g / mL are prepared. By preparing cesium acetate aqueous solutions within this density range, yttrium-90 glass microspheres with densities greater than 1.5 g / mL can be selected, thereby facilitating the preparation of uniform yttrium-90 glass microsphere suspensions that will not prematurely precipitate or be washed away by the bloodstream in vivo. Furthermore, the density of the cesium acetate aqueous solution is 2 g / mL, thus obtaining yttrium-90 glass microspheres with densities all greater than 2 g / mL.

[0034] In this application, the mass ratio of cesium acetate aqueous solution to yttrium-90 glass microspheres is from 2:1 to 40:1. By using such a mass ratio of cleaning solution and material to be cleaned, the yttrium-90 glass microspheres can be effectively cleaned without causing excessive waste. Further, the mass ratio of cesium acetate aqueous solution to yttrium-90 glass microspheres is 20:1.

[0035] In this application, to reduce nuclear contamination during the operation and improve operational safety, the cleaning operation is carried out under sealed conditions. Furthermore, personnel are required to wear protective equipment during microscopic observation.

[0036] Specifically, a cesium acetate aqueous solution with a density of 2 g / mL is placed in a cleaning container (e.g., a beaker), the opening of the cleaning container (e.g., the beaker) is sealed, and yttrium-90 glass microspheres are introduced.

[0037] In the above operation, there are no specific restrictions on the container, as long as it can hold an aqueous solution of cesium acetate.

[0038] There are no specific restrictions on the materials used to seal the openings, as long as they can prevent the leakage of radioactive materials or radiation pollution, such as tin foil or aluminum foil.

[0039] There are no specific restrictions on the method of introducing yttrium-90 glass microspheres, as long as it can prevent the leakage of radioactive materials or radiation contamination. For example, yttrium-90 glass microspheres can be introduced through pipelines. It should be understood that there are no specific restrictions on the pipelines, as long as they have excellent radiation resistance and chemical resistance properties. For example, ethylene propylene diene monomer (EPDM) rubber can withstand 100-200 kGy of radiation and has excellent chemical resistance properties, including resistance to acids, alkalis, detergents, animal and vegetable oils, alcohols, ketones, etc.; outstanding resistance to water, superheated water, and water vapor; and resistance to polar oils.

[0040] Specifically, the cleaning operation S1 can be carried out in the following way: the cleaning beaker is sealed with tin foil, and an inlet is opened in the center of the tin foil. The EPDM rubber tube is inserted into the inlet, and the Yttrium-90 glass microspheres are sent into the cleaning beaker through the EPDM rubber tube.

[0041] In this application, the cleaning operation S1 includes two sub-operations: vibration cleaning S1a and ultrasonic cleaning S1b (e.g., ...). Figure 2 (As shown).

[0042] "Vibration cleaning" refers to cleaning performed by means of "vibration". In this application, it needs to be repeated 2 to 4 times. After each vibration cleaning, it is left to stand for 0.5 hours to 1 hour to remove floating and suspended glass microspheres, thereby obtaining the desired density, for example, yttrium-90 glass microspheres with a density greater than 2 g / mL.

[0043] Specifically, vibration cleaning involves introducing yttrium-90 glass microsphere powder from a pipe into a cleaning container containing an aqueous solution of cesium acetate (e.g., with a density of 2 g / mL). Figure 3 (As shown), seal the container and place it in the vibration cleaner. Stir thoroughly by vibration for 10 to 20 minutes.

[0044] "Ultrasonic cleaning" refers to cleaning performed using "ultrasound." Ultrasonic cleaning typically utilizes an ultrasonic cleaning machine. It's important to understand that the principle of an ultrasonic cleaning machine involves a high-frequency oscillation signal emitted by an ultrasonic generator. This signal is converted into high-frequency mechanical oscillations by a transducer and propagated into the cleaning medium—the cleaning solvent. The ultrasonic waves radiate forward in the cleaning fluid, creating tens of thousands of tiny bubbles with diameters ranging from 50μm to 500μm. These tiny bubbles vibrate under the influence of the sound field. These bubbles form and grow in the negative pressure zone where the ultrasonic waves propagate longitudinally. In the positive pressure zone, when the sound pressure reaches a certain value, the bubbles rapidly enlarge and then suddenly collapse. This collapse generates a shock wave, creating thousands of atmospheres of pressure around it. This shock wave breaks down insoluble contaminants, dispersing them into the cleaning fluid. When aggregated particles are coated with oil and adhere to the surface of the part being cleaned, the oil is emulsified, and the solid particles detach, thus achieving the purpose of cleaning the part.

[0045] In this application, the cleaning container is placed into an ultrasonic cleaner for fixation. During this process, the cleaning container is sealed, and the container should be kept stable during transfer to avoid leakage. This fully ensures the sealing and stability of the container during the cleaning process and can effectively prevent leakage caused by tilting, thereby ensuring the safety of the cleaning and separation process.

[0046] In this application, after ultrasonic cleaning is completed, the container surface is observed for any floating matter (e.g., yttrium oxide). If floating matter is present, it is promptly removed. After cleaning, ultrasonic cleaning continues. After the floating matter is removed, the solution is replaced with 37°C physiological saline to soak and wash the precipitate, thereby thoroughly removing the yttrium oxide adhering to the surface of the glass microspheres. Subsequently, the solution is replaced with deionized water. This process can be repeated 2 to 4 times.

[0047] In this application, filtration and impurity removal S2 can be performed using filter paper. Filter paper is a scientific tool that can effectively filter impurities and has been widely used in various fields. Depending on the type of fiber that makes up the filter paper, its performance and uses vary. There are ordinary filter papers for general applications, glass fiber filter papers for high-temperature applications, and polypropylene filter papers for ultra-clean applications, etc. Glass fiber filter paper is made using a wet-forming process and has the characteristics of uniform fiber distribution, large dust holding capacity, low resistance, and high strength, making it an ideal air filtration material.

[0048] In this application, as Figure 4 As shown, the filtration and impurity removal S2 includes: rolling filter paper into a funnel shape, placing the filter paper in a receiving container (e.g., a beaker), and pouring ultrasonically cleaned yttrium-90 glass microspheres onto the filter paper for filtration and impurity removal. This process can be repeated 3 to 6 times, such as 3, 4, 5, or 6 times. Furthermore, this filtration and impurity removal operation also includes: neutralizing the filtered water with soapy water, for example, the volume ratio of filtered water to soapy water is 1:4 to 1:6, such as choosing to use a 1:5 soapy water solution, which is a soapy water solution with a volume of 5 times that of the solution to be treated.

[0049] In this application, drying S3 includes drying the yttrium-90 glass microspheres at 60°C to 80°C for 240 to 300 minutes. Specifically, the microspheres are placed in a drying oven together with the filter paper used in filtration and impurity removal S2 for drying. After drying, the filter paper is separated from the yttrium-90 glass microspheres (e.g., the yttrium-90 glass microspheres are scraped off the filter paper using a scraper). After removal, the filter paper is washed with soapy water and then disposed of uniformly (e.g., destroyed). The resulting yttrium-90 glass microspheres are placed in a constant temperature shaking apparatus for leaching rate testing.

[0050] Finally, cleaning equipment S4: Clean the utensils (e.g., beakers, funnels, receiving beakers), instruments (e.g., vibratory cleaners, ultrasonic cleaners) and dispose of the filter paper using soapy water. It should be understood that soapy water can be used not only to clean object surfaces but also to wash the body to remove surface radiation particles and radioactive materials, thereby reducing harm to the body. When using soapy water for cleaning, running water should be used, and the advice of a doctor should be followed to minimize radiation hazards.

[0051] In this application, it is preferable to use multiple radiation-resistant materials for sealing during the operation to prevent leakage and contamination of the laboratory during the cleaning and separation process. Furthermore, it is preferable to thoroughly clean the glassware and instruments used during the cleaning process to ensure no leakage or contamination occurs, thereby further improving the safety of the Yttrium-90 glass microsphere cleaning and separation. Moreover, it is preferable that personnel wear protective clothing when handling unsealed containers containing Yttrium-90 glass microspheres. For example, during vibration cleaning operations, when cleaning floating matter on the container surface, the beaker seal should be opened, and a strainer should be placed into the beaker for retrieval. Protective clothing should also be worn during microscopic observation.

[0052] The present invention will be described in more detail below through embodiments. It should be understood that the embodiments described below are exemplary and are only used to explain this application, and should not be construed as limiting this application. Where specific techniques or conditions are not specified in the embodiments, they shall be performed in accordance with the techniques or conditions described in the literature in the art or according to the product instructions. Reagents or instruments used, unless otherwise specified, are all conventional products that can be obtained commercially.

[0053] Example

[0054] Preparation of Yttrium-90 glass microspheres

[0055] Yttrium-90 glass microspheres were prepared according to the method described in CN117326785. Subsequently, the Yttrium-90 glass microspheres were observed using an optical microscope (MSD105 monocular, Mystar Technology Co., Ltd.) at 50x magnification. The obtained images are shown in... Figure 5 middle.

[0056] Preparation of cleaning agent

[0057] An aqueous solution of cesium acetate with a density of 2 g / mL was prepared using an electronic balance and a graduated cylinder.

[0058] Vibration cleaning

[0059] Place 30 mL of the prepared cesium acetate aqueous solution into a cleaning beaker, seal the beaker opening, and connect it to the yttrium-90 glass microsphere inlet pipe.

[0060] 3g of the prepared yttrium-90 glass microspheres were introduced into a cleaning beaker containing a cesium acetate aqueous solution through a pipe, and the beaker was sealed. The beaker was placed in a vibratory cleaner (Guohua, SHA-C) and thoroughly stirred by vibration for 15 minutes. After uniform stirring, it was allowed to stand for 0.5 hours to remove floating and suspended glass microspheres.

[0061] Repeat the above steps three times to obtain yttrium-90 glass microspheres with a density greater than 2 g / mL.

[0062] Ultrasonic cleaning

[0063] Seal the beaker containing the yttrium-90 glass microspheres (after the previous operation) and place it in an ultrasonic cleaner (Ningbo Xinzhi Biotechnology, SB-120DT). Secure it in place, set the cleaning time to 15 minutes, cleaning power to 30Hz, and cleaning temperature to 37℃. The beaker should be kept stable during transfer to prevent leakage and ensure its sealing and stability during the cleaning process.

[0064] Filtration and impurity removal

[0065] like Figure 4 As shown, the filter paper is rolled into a funnel shape and placed in a receiving beaker. The ultrasonically cleaned yttrium-90 glass microspheres are then poured onto the filter paper for filtration and impurity removal.

[0066] Repeat the above steps 3 times.

[0067] drying

[0068] Yttrium-90 glass microspheres, along with filter paper, were placed in a drying oven for 300 minutes at a temperature of 70°C. After drying, the Yttrium-90 glass microspheres were scraped off the filter paper with a scraper and collected in a container.

[0069] Equipment cleaning

[0070] Clean the beakers, vibratory cleaner, and ultrasonic cleaner used in the above process with soapy water, and destroy the filter paper.

[0071] Using an optical microscope (MSD105 monocular, Mystar Technology Co., Ltd.), at 50x magnification, the cleaned yttrium-90 glass microspheres were observed. The resulting images are shown in... Figure 6 middle.

[0072] Comparing the microscope images before and after cleaning, it can be seen that... Figure 5 The microscope image clearly shows a large number of impurities, while Figure 6 The presence of only yttrium-90 glass microspheres was observed under the microscope, indicating that the method of this application is effective and meaningful for the treatment of yttrium-90 glass microspheres.

[0073] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A method for cleaning and separating radioactive yttrium-90 glass microspheres, comprising the following operations: Yttrium-90 glass microspheres were washed with a cesium acetate aqueous solution having a density of 1.5 g / mL to 3 g / mL. Filtration and separation of washed yttrium-90 glass microspheres; and Dry the filtered and separated yttrium-90 glass microspheres.

2. The cleaning and separation method according to claim 1, wherein, The density of the cesium acetate aqueous solution is 2 g / mL.

3. The cleaning and separation method according to claim 1 or 2, wherein, The mass ratio of the cesium acetate aqueous solution to the yttrium-90 glass microspheres is 2:1 to 40:

1.

4. The cleaning and separation method according to claim 1 or 2, wherein, The mass ratio of the cesium acetate aqueous solution to the yttrium-90 glass microspheres is 20:

1.

5. The cleaning and separation method according to claim 1 or 2, wherein, In the cleaning process, the cesium acetate aqueous solution is placed in a container, the opening of the container is then sealed, and yttrium-90 glass microspheres are introduced.

6. The cleaning and separation method according to claim 1 or 2, wherein, The cleaning process includes first performing vibration cleaning and then performing ultrasonic cleaning, wherein the vibration cleaning is repeated 2 to 4 times.

7. The cleaning and separation method according to claim 6, wherein, The cleaning process further includes removing floating and suspended yttrium-90 glass microspheres after each vibration cleaning.

8. The cleaning and separation method according to claim 7, wherein, The vibration cleaning is performed at intervals of 0.5 to 1 hour.

9. The cleaning and separation method according to claim 6, wherein, The ultrasonic cleaning is performed for 10 to 15 minutes at a power of 20 Hz to 45 Hz and a temperature of 30°C to 40°C.

10. The cleaning and separation method according to claim 6, wherein, The ultrasonic cleaning was repeated 2 to 3 times, with the Yttrium-90 glass microspheres being soaked in 37°C physiological saline between ultrasonic cleaning sessions, followed by ultrasonic cleaning with deionized water.

11. The cleaning and separation method according to claim 1 or 2, wherein, The filtration is performed using glass fiber filter paper.

12. The cleaning and separation method according to claim 1 or 2, wherein, The filtering process is repeated 3 to 6 times.

13. The cleaning and separation method according to claim 1 or 2, wherein, The drying process is carried out at a temperature of 60°C to 80°C for 240 to 300 minutes.

14. The cleaning and separation method according to claim 1 or 2, wherein, The cleaning and separation method also includes cleaning the equipment, wherein the equipment includes the containers and instruments used in the method.

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