Efficient sterile filter membrane assembly for positron drug synthesis

Abstract

The utility model relates to an efficient sterile filter membrane component for positron drug synthesis, which comprises an upper body and a lower body, the upper body and the lower body are positioned on opposite sides of a liquid filter membrane, the upper body is communicated with the inlet end of a female Luer head, the lower body is communicated with the outlet end of a male Luer head, and the male Luer head is communicated with the liquid filter membrane. And a gas filter membrane hydrophobic filter is also arranged on the surface of the upper body. According to the utility model, the 0.22 [mu] m membrane filter is adopted, so that microorganisms, particles and undissolved powder larger than 0.22 [mu] m in a solution can be efficiently removed, the filtered solution is ensured to meet the sterile requirement, upstream air is automatically discharged through the 0.03 [mu] m gas filter membrane hydrophobic filter, air blockage is effectively prevented, and the smooth proceeding of the filtering process is ensured.

Description

Technical Field

[0001] The utility model relates to the technical fields of medical devices and radioactive drug preparation, and particularly relates to a high-efficiency sterile filter membrane assembly for positron drug synthesis. Background Technique

[0002] Positron-emitting radiopharmaceuticals are drugs used in nuclear medicine imaging such as PET scans, containing radioactive isotopes such as fluorine-18 and carbon-11. They bind to biomolecules for localization and are commonly used for the diagnosis and evaluation of cancer, neurodegenerative diseases, and cardiovascular diseases. These drugs have short half-lives, reducing patient radiation exposure. Their preparation is complex and requires sophisticated chemical synthesis and nuclear reaction techniques. Positron drugs play an important role in clinical practice, providing biological information to help improve disease management. With the continuous development of PET technology, positron-emitting radiopharmaceuticals play a key role in nuclear medicine imaging, providing a reliable basis for the accurate diagnosis and treatment of diseases by binding radioactive isotopes to biomolecules for localization.

[0003] Currently, positron-emitting radiopharmaceuticals are mainly synthesized through a synthesis module. During the synthesis process, to obtain sterile positron radioactive drugs, sterile filter membranes are needed. In the pharmaceutical field, especially during the synthesis of positron drugs, the sterile filtration of solutions is a key step. The selection and use of sterile filters directly affect the production, quality, and safety of positron drugs. Traditional filters often have problems such as low filtration efficiency and easy clogging, and cannot meet the high requirements of positron drug synthesis. Content of the Utility Model

[0004] To achieve the above object, the utility model provides the following technical solution:

[0005] A high-efficiency sterile filter membrane assembly for positron drug synthesis, comprising an upper body and a lower body, wherein the upper body and the lower body are positioned on opposite sides of a liquid filter membrane, the upper body communicates with the inlet end of a female Luer connector, the lower body communicates with the outlet end of a male Luer connector, and a gas filter membrane hydrophobic filter is further arranged on the surface of the upper body.

[0006] As a preferred scheme of the utility model, the upper body and the lower body form a domed shape.

[0007] As a preferred scheme of the utility model, the upper body and the lower body are made of polycarbonate material.

[0008] As a preferred scheme of the utility model, the liquid filter membrane adopts a 0.22-micron hydrophilic mixed cellulose membrane or a polyethersulfone membrane.

[0009] As a preferred scheme of the utility model, the gas filter membrane hydrophobic filter adopts a 0.03-micron polyvinylidene fluoride membrane.

[0010] Compared with the prior art, the beneficial effects of the present utility model are as follows:

[0011] 1. The present utility model mainly consists of a disposable 0.22μm membrane filter, which is sealed in a plastic outer casing. In addition, the membrane filter assembly further includes a 0.03μm gas membrane hydrophobic filter located in the dome. The gas membrane hydrophobic filter prevents air blockage by discharging the upstream air, thereby ensuring that no blockage occurs during the aseptic filtration of positron drugs and enabling a sterile product to be obtained smoothly.

[0012] 2. By using a 0.22μm membrane filter, microorganisms, particles, and undissolved powders larger than 0.22μm in the solution can be efficiently removed, ensuring that the filtered solution meets the aseptic requirements. The upstream air is automatically discharged through the 0.03μm gas membrane hydrophobic filter, effectively preventing air blockage and ensuring the smooth progress of the filtration process.

[0013] 3. The filter membrane is a disposable product, which is convenient to use and avoids the possible contamination problems caused by repeated use. The filter membrane material is pyrogen-free and non-toxic, meeting the requirements for material safety in the medical field. It can be applied to solutions dispensed using syringes and can be widely used in the field of positron drug synthesis. Description of the Drawings

[0014] Figure 1 is a schematic structural diagram of the present utility model;

[0015] In the figure: 1 upper body, 2 lower body, 3 liquid filter membrane, 4 female Luer head, 5 male Luer head, 6 gas membrane hydrophobic filter. Detailed Embodiments

[0016] Next, the technical solutions in the embodiments of the present utility model will be clearly and completely described in conjunction with the embodiments of the present utility model. Obviously, the described embodiments are only a part of the embodiments of the present utility model, rather than all the embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present utility model.

[0017] Embodiment 1

[0018] Please refer to Figure 1An efficient sterile filter membrane assembly for positron drug synthesis, as shown, includes an upper body 1 and a lower body 2. The upper body 1 and the lower body 2 are positioned on opposite sides of a liquid filter membrane 3. The upper body 1 communicates with the inlet end of a female Luer head 4, and the lower body 2 communicates with the outlet end of a male Luer head 5. A gas filter membrane hydrophobic filter 6 is also provided on the surface of the upper body 1. The upper body 1 and the lower body 2 form a dome shape. The upper body 1 and the lower body 2 are made of polycarbonate material. The liquid filter membrane 3 is a 0.22-micron hydrophilic mixed cellulose membrane or polyethersulfone membrane, and the gas filter membrane hydrophobic filter 6 is a 0.03-micron polyvinylidene fluoride membrane.

[0019] During use, connect this sterile filter membrane assembly to a syringe, and inject the solution to be filtered into the filter membrane through the syringe. The solution is filtered through a 0.22-μm liquid membrane filter to remove microorganisms, particles, and undissolved powders larger than 0.22 μm. At the same time, the 0.03-μm gas filter membrane hydrophobic filter automatically discharges the upstream air to prevent air blockage. Finally, the filtered sterile solution is dispensed through a dispensing device for the synthesis of positron drugs.

[0020] The design of the present utility model adopts a double-layer filtration structure. In addition to the 0.22-micron liquid membrane filter, a 0.03-micron gas filter membrane hydrophobic filter is added to the dome part. This design effectively prevents air blockage through the function of automatically emptying the upstream air, ensuring unobstructed flow during the sterile filtration process of positron drug synthesis and avoiding the blockage problems that may occur in traditional filtration processes.

[0021] This filter membrane device fits tightly with the pipeline of the synthesis module, facilitating solution dispensing. The overall structure is compact and easy to operate, enabling positron drugs to complete the filtration process efficiently and safely in a strict sterile environment, thereby obtaining high-quality sterile products.

[0022] Specific embodiment: 6- 18 F-L-3,4-dihydroxyphenylalanine ( 18 F-DOPA) preparation:

[0023] During the production 18 of F-DOPA, through a cyclotron, 18F ions. These ions are captured by an anion exchange column (QMA) and eluted into a reaction flask using an aqueous potassium carbonate solution and an acetonitrile solution of K2.2.2. After evaporation to dryness to remove acetonitrile and water, the DOPA precursor (7 mg / 1 ml DMF) is then added to the reaction flask and reacted at 110 °C for 10 minutes, and then cooled to room temperature. 40 mL of 30% acetonitrile is added, and the mixture is captured by a C-18 column. Subsequently, the C18 column is rinsed with another 40 mL of 30% acetonitrile to achieve preliminary purification. The intermediate is eluted with acetonitrile into a reaction tube and heated under vacuum to remove the acetonitrile solvent. Then, an acetonitrile solution containing 10 mg of m-chloroperoxybenzoic acid is added to the reaction tube, cooled after reacting at 70 °C for 18 minutes, then 2 mL of 30% hydrochloric acid solution is added, and heated at 65 °C for 10 minutes. Subsequently, it is neutralized with 1.5 ml of 1 M sodium hydroxide solution at room temperature and transferred to a C-18 and HP-R tandem column for capture. It is rinsed with 10 ml of injection water, and the waste liquid flows into the waste liquid bottle. Finally, the C-18 and HP-R columns are rinsed with 10 ml of injection water buffer solution and filtered through a sterile filter membrane to finally obtain the 18 F-DOPA product.

[0024] Although the embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention, and the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. An efficient sterile filter membrane assembly for positron drug synthesis, characterized in that: It includes an upper body (1) and a lower body (2), the upper body (1) and the lower body (2) are positioned on opposite sides of a liquid filter membrane (3), the upper body (1) communicates with the inlet end of a female Luer connector (4), the lower body (2) communicates with the outlet end of a male Luer connector (5), and a gas filter membrane hydrophobic filter (6) is also provided on the surface of the upper body (1).

2. The high-efficiency sterile filter membrane assembly for positron drug synthesis according to claim 1, wherein: The upper body (1) and the lower body (2) form a dome shape.

3. An efficient and sterile filter membrane assembly for positron drug synthesis according to claim 1, characterized in that: The upper body (1) and the lower body (2) are made of polycarbonate material.

4. The high-efficiency sterile filter membrane assembly for positron drug synthesis according to claim 1, wherein: The liquid filter membrane (3) is a 0.22-micron hydrophilic mixed cellulose membrane or polyethersulfone membrane.

5. The high-efficiency sterile filter membrane assembly for positron drug synthesis according to claim 1, characterized in that: The gas filter membrane hydrophobic filter (6) is a 0.03-micron polyvinylidene fluoride membrane.

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