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Automatic leaching, synthesizing and sub-packaging method of technetium [99mTc] labeled drug

An automatic synthesis and labeling technology, which is applied in the field of synthesis and sub-packaging, and automatic elution of technetium [99mTc]-labeled drugs, can solve the problems that are difficult to comply with the principles of repeatability and stability of drug production, the high risk of radiation for workers, and the inability to Good compliance with GMP production specifications and other issues

Active Publication Date: 2021-09-07
JIANGSU HUAYI TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the actual operation process, it will bring a greater radiation risk to the staff, and it cannot better meet the GMP production specifications
Manual operation is greatly affected by personnel and other factors, and it is difficult to meet the repeatability and stability principles of pharmaceutical production

Method used

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  • Automatic leaching, synthesizing and sub-packaging method of technetium [99mTc] labeled drug

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Technetium [ 99m Tc] methylene diphosphate ( 99m Tc-MDP) as an example, its automatic washing, synthesis and packaging methods are as follows:

[0043] (1) Dissolve the MDP freeze-dried kit with 1ml sodium chloride injection, and place it in the reaction bottle 12 in advance. All the following operations are computer-controlled and automated.

[0044] (2) Valve six 6 is connected to molybdenum-technetium generator 15, valve six 6 is turned right, valve seven 7 is horizontal, valve eight 8 is turned left, the syringe 14 draws about 3ml, and the sodium pertechnetate solution is rinsed into the syringe 14 to complete the automatic Rinsing process.

[0045] (3) Valve eight 8 turn left, valve six 6, valve seven 7 level, valve two 2 turn right, valve three 3 turn left, syringe 14 drops about 3ml, inject sodium pertechnetate solution into reaction bottle 12.

[0046] (4) Labeling synthesis reaction at room temperature for 5 minutes, the reaction volume is about 4ml, and th...

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PUM

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Abstract

The invention discloses an automatic leaching, synthesizing and sub-packaging method of a technetium [99mTc] labeled drug. The method comprises the following steps: providing an automatic synthesis module; connecting an inlet of a molybdenum-technetium generator to a leacheate bottle, and connecting an outlet of the molybdenum-technetium generator to a sixth valve; connecting an injector to an eighth valve through a pipeline; connecting a reaction bottle to a third valve and a seventh valve through pipelines, connecting a diluent bottle to a tenth valve through a pipeline, and connecting a packaging container to a fourth valve through a product tube; through cooperation of an injector, a molybdenum technetium generator, a leacheate bottle, a reaction bottle, a diluent, a packaging container and an automatic synthesis module, automatic leaching, synthesis and split charging of technetium [99mTc] labeled drugs are achieved. According to the method, repeatable and stable automatic production of technetium [99mTc] labeled drugs can be met, the GMP production specification is met, and radiation suffered by workers can be reduced to the maximum extent.

Description

technical field [0001] The present invention relates to the technical field of automated synthesis methods, in particular to a technetium[ 99m A method for automatic elution, synthesis and packaging of Tc] labeled drugs. Background technique [0002] Technetium [ 99m Tc]-labeled drugs are radiopharmaceuticals used in the diagnosis of single photon emission computed tomography (SPECT), and are currently the most important and widely used single photon emission computed tomography drugs. [0003] Technetium [ 99m The Tc] nuclide comes from a molybdenum-technetium generator, and the high technetium[ 99 Sodium mTc] acid solution and different labeled substrates are labeled and synthesized, and different technetium [ 99m Tc] labeled drug. Such as high technetium [ 99m Tc] acid sodium solution and methylene diphosphoric acid (MDP) reaction to generate 99m Tc-MDP is currently recognized as an ideal bone imaging agent, mainly used for whole body or local bone imaging, diagnos...

Claims

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Application Information

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IPC IPC(8): B65B3/00B65B3/04B65B55/24C07F9/38A61K51/04A61K103/10
CPCB65B3/003B65B55/24B65B3/04A61K51/0489C07F9/3808
Inventor 褚平
Owner JIANGSU HUAYI TECH
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