EP2575142B1 - Méthode d'améliorer la pureté et le rendement d'un produit chimique dans un système automatique de synthèse de médecine radioactif - Google Patents

Méthode d'améliorer la pureté et le rendement d'un produit chimique dans un système automatique de synthèse de médecine radioactif Download PDF

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Publication number
EP2575142B1
EP2575142B1 EP20110401600 EP11401600A EP2575142B1 EP 2575142 B1 EP2575142 B1 EP 2575142B1 EP 20110401600 EP20110401600 EP 20110401600 EP 11401600 A EP11401600 A EP 11401600A EP 2575142 B1 EP2575142 B1 EP 2575142B1
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EP
European Patent Office
Prior art keywords
electromagnetic valve
flowing
enter
buffer tube
adhesion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Not-in-force
Application number
EP20110401600
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German (de)
English (en)
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EP2575142A1 (fr
Inventor
Chia-Jung Chang
Mei-Hsiu Liao
Lie-Hang Shen
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Institute of Nuclear Energy Research
Atomic Energy Council
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Institute of Nuclear Energy Research
Atomic Energy Council
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Priority to EP20110401600 priority Critical patent/EP2575142B1/fr
Publication of EP2575142A1 publication Critical patent/EP2575142A1/fr
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Publication of EP2575142B1 publication Critical patent/EP2575142B1/fr
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    • G—PHYSICS
    • G21—NUCLEAR PHYSICS; NUCLEAR ENGINEERING
    • G21G—CONVERSION OF CHEMICAL ELEMENTS; RADIOACTIVE SOURCES
    • G21G1/00—Arrangements for converting chemical elements by electromagnetic radiation, corpuscular radiation or particle bombardment, e.g. producing radioactive isotopes
    • G21G1/0005—Isotope delivery systems

Definitions

  • the present invention relates to a radioactive medicine synthesis system; more particularly, relates to improving purity and yield of chemical product in an automatic radioactive medicine synthesis system.
  • Nuclear medicine uses affinitive column for adhesion of target medicine to obtain product after washing and eluting.
  • iodine isotope would process radioiodination in a buffer containing an oxidant.
  • yield of target and purity of radioactive chemical medicine are affected by the volume of solution; time for oxidation; and arrangement of adhesion, washing and eluting processes.
  • the yield and purity may become bad with high cost and the product obtained may become useless.
  • the source has to be increased. But, following the increase in source, its volume is increased too. As a result, the yield and purity are still not increased or even decreased.
  • a prior art separates the adhesion process and the washing process to reduce pollution of impurities.
  • the prior art is automated. The operators only have to take the column manually for washing at the final stage. However, the activity of the column may be still high, the pollution may happen to the operators or there may be a chance for operation mistake in the time before washing.
  • the easiest way for increasing the chemical production is to increase the volume of the reactants. But, in fact, it is not so simple. For example, the total volume for the reactions is critical.
  • reaction of radioiodination is processed in a liquid state and some reaction solutions can not be condensed, so that the yield may not be increased following the increase of the total reaction volume.
  • radioiodination may contains some incomplete reactions so that some unreacted iodine will be left over.
  • Purification has to be done to the product through processes of adhesion (of the product), washing and elution with an affinitive column, where the adhesion process includes processes of repeated back-and-forth flowing through the column to increase efficiency of adhesion.
  • the reaction solution filled in the column has a volume smaller than the total reaction volume, some problems may occur in the automatic system, even though an adhesion batch may be designed in theory. Because the column has a small diameter and the liquid has surface tension, incomplete adhesion may happen during the repeated flowing processes and some waste solution may be generated and discharged.
  • EP 1 772 157 A describes a synthesis method for manufacturing radiopharmaceuticals and nuclides in a module with a syringe pump unit.
  • the method comprises formation and/or introduction of a radioactive substance, processing the radioactive substance in at least one production facility, and ejection of the produced radiopharmaceuticals or nuclides
  • the method is carried out by means of pumping and suction operations of the syringe pump unit.
  • the main purpose of the present invention is to increase a number of target reaction containers from one into many for increasing reaction volume coordinated with increased reaction times and, by modifying an affinitive column of an automatic synthesis system, to increase production in a single batch conformed to quality check specifications.
  • the main purpose of the present invention is provide an automatic way to separate adhesion process and washing process by switching electromagnetic valves coordinated with different sizes of buffer tubes for increasing production and reducing cost
  • the present invention is a method of improving purity and yield of chemical product in an automatic radioactive medicine synthesis system, comprising steps of: (a) washing by: inputting a total solution of total solution by nitrogen gas to be flown through a second electromagnetic valve, a first electromagnetic valve and a fourth electromagnetic valve to enter into a first buffer tube; flowing said total solution through a sixth electromagnetic valve to enter an adhesion column to process adhesion; flowing said total solution through an eighth electromagnetic valve and a seventh electromagnetic valve to enter a second buffer tube; flowing a waste gas through a fifth electromagnetic valve and a third electromagnetic valve to be discharged; and staying said total solution in said second buffer tube; (b) backwashing by: flowing nitrogen gas through said second electromagnetic valve, said third electromagnetic valve and said fifth electromagnetic valve to push out said total solution in said second buffer tube; flowing said total solution through said seventh electromagnetic valve and said eighth electromagnetic valve to enter said adhesion column to process adhesion; flowing said total solution through said sixth electromagnetic valve to enter said first buffer tube; and flowing a waste gas through said fourth electromagnetic
  • FIG.1 is a structural view showing devices used in a preferred embodiment according to the present invention.
  • the present invention is a method of improving purity and yield of chemical product in an automatic radioactive medicine synthesis system, where an original chemical reaction are divided into multiple reactions with adhesions processed after the multiple reactions; and where the adhesions have a total solution flowing back and forth along an adhesion column 1 several times for enhancing adhesion efficiency. Since the total solution has a big volume, the adhesion column 1 is separately added with a buffer tube 21,22 at each end of the adhesion column 1 for guiding the flowing of the total solution coordinated with a plurality of three-way electromagnetic valves 31 ⁇ 39.
  • the column For removing unreacted radioactive iodine, the column must be cleaned.
  • the present invention added two more buffer tubes 23,24 for washing and backwashing to separate processes of adhesion and washing for improving washing effect with the coordination of the three-way electromagnetic valves 31 ⁇ 39.
  • FIG.2 to FIG.7 are views showing processes of washing with adhesion, backwashing with adhesion, discharging reaction solutions, backwashing, washing and eluting out product.
  • the present invention comprises the following steps:
  • the first to the ninth electromagnetic valves 31 ⁇ 39 are three-way electromagnetic valves; and, the first and the second buffer tubes 21,22 have diameters and volumes bigger than the third and the fourth buffer tubes 23,24.
  • the present invention increases a number of target reaction containers from one into many (e.g. three) for increasing reaction volume coordinated with increased reaction times.
  • An affinitive column of an automatic synthesis system is modified for increasing production in a single batch conformed to quality check specifications.
  • the present invention separates a chemical reaction into many reactions for repeatedly processing original reactions to avoid reducing yield on increasing reaction volume.
  • the present invention adds two plastic tubes at head and tail ends of the column to be used as buffer tubes for not only processing adhesion several times but also for solving the problem of incomplete adhesion for reaction solution owing to surface tension (i.e. waste solution).
  • the present invention adds two empty columns at head and tail ends of the column to be used as buffer tubes to separate adhesion process and washing process with coordination of electromagnetic valves for controlling to obtain products conformed to quality check specifications.
  • the present invention is a method of improving purity and yield of chemical product in an automatic radioactive medicine synthesis system, where, in an automatic way, adhesion process and washing process are separated by switching electromagnetic valves coordinated with different sizes of buffer tubes for increasing production and reducing cost.

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  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Engineering & Computer Science (AREA)
  • General Engineering & Computer Science (AREA)
  • High Energy & Nuclear Physics (AREA)
  • Physical Or Chemical Processes And Apparatus (AREA)

Claims (3)

  1. Procédé pour améliorer la pureté et le rendement d'un produit chimique dans un système automatique de synthèse de médicaments radioactifs, comprenant les étapes de :
    (a) lavage par introduction d'une solution totale de solutions réactionnelles, grâce à de l'azote gazeux devant s'écouler par une deuxième électrovanne (32), une première électrovanne (31) et une quatrième électrovanne (34) pour pénétrer dans un premier tube tampon (21) ; écoulement de ladite solution totale par une sixième électrovanne (36) pour pénétrer dans une colonne d'adhérence (1) pour permettre l'opération d'adhérence; écoulement de ladite solution totale par une huitième électrovanne (38) et une septième électrovanne (37) pour pénétrer dans un deuxième tube tampon (22) ; écoulement d'un effluent gazeux par une cinquième électrovanne (35) et une troisième électrovanne (33) pour évacuation ; et maintien de ladite solution totale dans ledit deuxième tube tampon (22) ;
    (b) rinçage en retour, par : écoulement d'azote gazeux par ladite deuxième électrovanne (32), ladite troisième électrovanne (33) et ladite cinquième électrovanne (35) pour déplacer ladite solution totale dans ledit deuxième tube tampon (22) ; écoulement de ladite solution totale par ladite septième électrovanne (37) et ladite huitième électrovanne (38) pour pénétrer dans ladite colonne d'adhérence (1) pour permettre l'opération d'adhérence ; écoulement de ladite solution totale par ladite sixième électrovanne (36) pour pénétrer dans ledit premier tube tampon (21) ; et écoulement d'un effluent gazeux par ladite quatrième électrovanne (34) et ladite première électrovanne pour évacuation ;
    (c) évacuation de la solution réactionnelle par : écoulement d'azote gazeux par ladite deuxième électrovanne (32), ladite première électrovanne (31) et ladite quatrième électrovanne (34) pour déplacer ladite solution totale maintenue dans ledit premier tube tampon (21) ; écoulement de ladite solution totale par ladite sixième électrovanne (36), ladite huitième électrovanne (38) et une neuvième électrovanne (39) pour évacuation ;
    (d) rinçage en retour par : écoulement d'un fluide de nettoyage par ladite deuxième électrovanne (32), ladite troisième électrovanne (33) et ladite cinquième électrovanne (25) pour pénétrer dans un quatrième tube tampon (24) ; écoulement dudit fluide de nettoyage par ladite septième électrovanne (37) et ladite huitième électrovanne (38) pour pénétrer dans ladite colonne d'adhérence (1) pour éliminer les impuretés par lavage ; écoulement dudit fluide de nettoyage par ladite sixième électrovanne (36) pour pénétrer dans un troisième tube tampon (23) ; et écoulement dudit fluide de nettoyage par ladite quatrième électrovanne (34) et ladite première électrovanne (31) pour évacuation ;
    (e) lavage par : écoulement d'un fluide de nettoyage par ladite deuxième électrovanne (32), ladite première électrovanne (31) et ladite quatrième électrovanne (34) pour pénétrer dans ledit troisième tube tampon (23) ; écoulement dudit fluide de nettoyage par ladite sixième électrovanne (36) pour pénétrer dans ladite colonne d'adhérence (1) pour éliminer les impuretés par lavage ; et écoulement dudit fluide de nettoyage par ladite huitième électrovanne (38) et ladite neuvième électrovanne (39) pour évacuation ; et
    (f) élution du produit par : écoulement d'un fluide d'élution par ladite deuxième électrovanne (32), ladite première électrovanne (31) et ladite quatrième électrovanne (34) pour pénétrer dans ledit troisième tube tampon (23) ; écoulement dudit fluide d'élution par ladite sixième électrovanne (36) pour pénétrer dans ladite colonne d'adhérence (1) pour éliminer un produit par élution ; et écoulement dudit produit par ladite huitième électrovanne (38) et ladite neuvième électrovanne (39) pour écoulement en sortie.
  2. Procédé selon la revendication 1, dans lequel lesdits première à neuvième électrovannes (31-39) sont des électrovannes à trois voies.
  3. Procédé selon la revendication 1, dans lequel lesdits première et deuxièmes tubes tampons (21, 22) ont des diamètres et des volumes supérieurs à ceux dudit troisième et dudit quatrième tubes tampons (23, 24).
EP20110401600 2011-09-27 2011-09-27 Méthode d'améliorer la pureté et le rendement d'un produit chimique dans un système automatique de synthèse de médecine radioactif Not-in-force EP2575142B1 (fr)

Priority Applications (1)

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EP20110401600 EP2575142B1 (fr) 2011-09-27 2011-09-27 Méthode d'améliorer la pureté et le rendement d'un produit chimique dans un système automatique de synthèse de médecine radioactif

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EP20110401600 EP2575142B1 (fr) 2011-09-27 2011-09-27 Méthode d'améliorer la pureté et le rendement d'un produit chimique dans un système automatique de synthèse de médecine radioactif

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EP2575142A1 EP2575142A1 (fr) 2013-04-03
EP2575142B1 true EP2575142B1 (fr) 2015-04-01

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Family Cites Families (4)

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Publication number Priority date Publication date Assignee Title
US5368736A (en) * 1993-07-26 1994-11-29 The United States Of America As Represented By The United States Department Of Energy Process for the separation and purification of yttrium-90 for medical applications
ATE527038T1 (de) * 2001-06-22 2011-10-15 Pg Res Foundation Inc Automatisiertes system und verfahren zur trennung von radionukliden
EP1772157A1 (fr) * 2005-10-06 2007-04-11 Karl-Heinz Jansen Assemblage modulaire et synthése pour la production des radiopharmaceutiques et des nucleides
US7586102B2 (en) * 2006-08-14 2009-09-08 Board Of Regents The University Of Texas System Automated system for formulating radiopharmaceuticals

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