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Disposable auxiliary device and method for preparing radioactive medicament

A technology of radiopharmaceuticals and auxiliary devices, applied in the directions of radioactive carriers, organic chemistry methods, chemical instruments and methods, etc., can solve the problems of excluding or not including semi-preparative HPLC purification and formulation, and residues.

Pending Publication Date: 2018-06-29
XUANWU HOSPITAL OF CAPITAL UNIV OF MEDICAL SCI
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

PET drugs were initially synthesized manually. The problem is that operators are exposed to more radiation, and are easily affected by human factors, and the yield is unstable. Therefore, automatic radiopharmaceutical synthesis equipment has been developed and widely used in the preparation of PET drugs.
Neptisperform type from ORA company, TRACERlab MX type from GE company, and Explora one type from German SIEMENS company use five-way three-way valves to control fluid flow. Disposable cartridges for preparing different drugs are already on the market, including the following types:[ 18 F]FET, [ 68 Ga] Ga-peptides, [ 18 F] F-L-Dopa, [ 18 F] FLT, [ 18 F] NaF, [ 18 F] SFB, [ 18 F] FES, [ 18 F]FMISO, [ 18 F] F-Choline, [ 18 F] Acetate, the preparation cartridges of these drugs are all used in combination with three five-way three-way valves, but the disadvantages of the existing disposable cartridges are: it does not include the semi-preparative high performance liquid chromatography purification function; it does not include Product preparation part
But its shortcoming is: adopt piercing device, on the one hand can not guarantee that reagent is all added in the reaction bottle or is drawn out; Labeled precursor compounds are generally more expensive, and there will be more or less residues with piercing devices; in addition, semi-preparative HPLC purification and formulation parts are not included

Method used

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  • Disposable auxiliary device and method for preparing radioactive medicament
  • Disposable auxiliary device and method for preparing radioactive medicament

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Example 1: Preparation of radiopharmaceutical (2R, 3R, 11bR)-9-(3-[ 18 F]fluoropropyl)-3-isobutyl-10-methoxy-2,3,4,6,7,11b-hexahydro-1H-pyrido[2,1-a]-isoquinoline- 2-ol ([ 18 F] FP-(+)-DTBZ).

[0073] Items and materials:

[0074] The aqueous solution containing radionuclide F-18 was produced by Siemens RDS111 cyclotron; the phase transfer catalyst amino polyether 222 and 250mL bagged water for injection were purchased from ABX Chemical Co., Ltd.; K 2 CO 3 , Acetonitrile, and DMSO were purchased from Sigma-Aldrich; ethanol and sodium ascorbate were purchased from Spectrum Chemical Co., Ltd.; QMA, Oasis solid-phase extraction cartridges were purchased from Waters; sterile filter membranes were purchased from Millipore.

[0075] Precursor compound reference [Kung Mei-Ping, Hou Catherine, Goswami Rajesh, PondeDatta E., Kilbourn Michael R., Kung, Hank F..Characterization of optically resolved 9-fluoropropyl-dihydrotetrabenazine as a potential PET imaging agenttargeting ...

Embodiment 2

[0088] Example 2: Preparation of radiopharmaceutical (s)-(-)-N-(1-allylpyrrolidine-2-aminomethyl)-5- fluorine[ 18 F] propyl-2,3-dimethoxybenzamide ([ 18 F]Fallypride)

[0089] Items and materials:

[0090] Precursor compounds were purchased from ABX Chemical Co., Ltd., DMF was purchased from Sigma-Aldrich Company, and the sources of other items were the same as in Example 1.

[0091] Preparation:

[0092] (1) Device installation:

[0093] Install the disposable auxiliary device (disposable ferrule device) on the Neptis Perform synthesis instrument of ORA Company in Belgium (or the TRACERlab MX of GE Company in the United States or the Explora one radiopharmaceutical synthesis instrument of SIEMENS Company in Germany) to ensure that the first reaction is performed five times three times. The through valve 1 to the formulation five-way three-way valve 4 are installed in the corresponding card slots, and the joints are tightly connected, and the first reaction bottle 16 is p...

Embodiment 3

[0102] Example 3: Preparation of radiopharmaceutical (s)-(-)-N-(1-allylpyrrolidine-2-aminomethyl)-5-fluoro[ 18F] propyl-2,3-dimethoxybenzamide ([ 18 F]Fallypride)

[0103] Items and materials:

[0104] Consistent with the source of embodiment 2.

[0105] Preparation:

[0106] (1) Device installation:

[0107] Install the disposable auxiliary device (disposable ferrule device) on the Neptis Perform synthesis instrument of ORA Company in Belgium (or the TRACERlab MX of GE Company in the United States or the Explora one radiopharmaceutical synthesis instrument of SIEMENS Company in Germany) to ensure that the first reaction is performed five times three times. The through valve 1 to the formulation five-way three-way valve 4 are installed in the corresponding card slots, and the joints are fastened. The first reaction bottle 16 is placed in the heating hole of the Neptis Perform type synthesis instrument; the third reaction five-way three-way The thirteenth three-way valve 3...

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Abstract

The invention relates to a disposable auxiliary device and a method for preparing a radioactive medicament, and belongs to the technical field of radioactive medicament preparation devices. The disposable auxiliary device consists of the following parts: three radiation chemical reaction five-union three-way valves and a product preparation five-union three-way valve which are connected in sequence; the left end of a first three-way valve of the radiation chemical reaction five-union three-way valves is connected to an air supply port through a Luer taper and a silicone tube; the upper end ofthe first three-way valve is connected to a target material recycling port; a second three-way valve is connected with a conical container which is filled with a radionuclide F-18 through a small ionexchange column; a thirteenth three-way valve of the radiation chemical reaction five-union three-way valves is connected with a semi-preparation type HPLC sampling port through another Luer taper. The device provided by the invention is applicable to purifying semi-preparation type HPLC of the radioactive medicament, ensures that a reagent is completely added into or pumped out from a reaction bottle, can ensure the consistency of using amounts of the reagent, is beneficial to standardization of radioactive medicament production, and can reduce the using amount of the reagent.

Description

technical field [0001] The invention relates to an auxiliary device for preparing radiopharmaceuticals and a method for preparing radiopharmaceuticals using the same, in particular to a disposable auxiliary device and method for preparing radiopharmaceuticals, belonging to the technical field of radiopharmaceutical preparation devices. Background technique [0002] Positron emission tomography (PET) is a clinical and practical medical imaging method. It detects the changes in the distribution, quantity and function of biomarkers in the human body through targeted radiopharmaceuticals, and realizes non-invasive detection of pathological changes at the living level. the goal of. Radiopharmaceuticals are the key to the function of PET. This type of drug is labeled with a medical radionuclide that emits positrons. The half-life of this type of radionuclide is short, so radiopharmaceuticals need to be prepared before use. PET drugs were initially synthesized manually. The proble...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07B59/00C07D455/03C07D207/09C07D471/04A61K51/04B01J47/022A61K101/02
CPCA61K51/0446A61K51/0455C07B59/002C07D207/09C07D455/03C07D471/04B01J47/022
Inventor 乔洪文卢洁陈彪
Owner XUANWU HOSPITAL OF CAPITAL UNIV OF MEDICAL SCI
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