JP2004279192A - Radioactivity prediction apparatus, radioactivity prediction method, and labeled compound production apparatus - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a radioactivity prediction apparatus for predicting the intensity of radioactivity of a labeled compound to be produced, a radioactivity prediction method, and a labeled compound production apparatus. <P>SOLUTION: The amount of radiation radiated from a solid state extraction column 103 or a hydrolytic cleavage 110 during a prescribed process are acquired by an in-instrument radiation acquisition means 79, and the prediction of intensity of the radioactivity of the labeled compound to be obtained after the prescribed process is obtained in the midway of the prescribed process based on the value obtained by a radioactivity intensity prediction processor 78c. Consequently, the prediction value of the labeled compound to be finally obtained can be grasped corresponding to problems even in case of the problems that in the midway of processing radio-isotopes are scattered from the solid state extraction column 103 etc. Accordingly, in case of the problems happen to occur, an alteration of a clinical schedule, a preparation for re-production of the labeled compound can be speedily performed. <P>COPYRIGHT: (C)2005,JPO&NCIPI

Description

ここで、Ｔ_０．５は^１８Ｆの半減期（ｓ）である。
【００５３】
なお、予測値Ｎ_ｐｒｅｄの取得から所定の時間が経っても製造が開始されない場合は、所定の時間毎に放射能の強さの予測値を再び取得する。
【００５４】
また、放射能予測値演算部７８ｃは、製造工程がスタートし固相抽出カラム１０３内の放射能の強さＮ_２が最大値を記録した場合には、この最大値に対応する時刻ｔ_２ｍａｘでの残時間Ｔ_２ｍａｘを取得し、（１）式において、Ｔ＝Ｔ_２ｍａｘ、Ｎ_０＝Ｎ_２、ε＝ε_２とし、製造されるＦＤＧの放射能の強さＮの予測値Ｎ_{ｐｒｅｄ１}を取得する。
【００５５】
なお、最大値が取得された後は、所定の時間の経過毎に放射能の強さの予測値を再び取得する。
【００５６】
また、放射能予測値演算部７８ｃは、製造工程がスタートし、加水分解容器１１０内の放射能の強さＮ_３が最大値を記録した場合には、この最大値に対応する時刻ｔ_３ｍａｘでの残時間Ｔ_３ｍａｘを取得し、（１）式においてＴ＝Ｔ_３ｍａｘ、Ｎ_０＝Ｎ_３、ε＝ε_３とし、製造されるＦＤＧの放射能の強さＮの予測値Ｎ_{ｐｒｅｄ２}を取得する。
【００５７】
さらに、放射能予測値演算部７８ｃは、加水分解容器１１０内の放射能の強さＮ_３が最大値を記録した後には、所定時間毎に、（１）式においてＴ＝Ｔ_ｒ、Ｎ_０＝Ｎ_３、ε＝ε_３とし、製造されるＦＤＧの放射能の強さＮの予測値Ｎ_{ｐｒｅｄ３}を取得する。
【００５８】
表示器７６は、放射能予測値演算部７８ｃが予測した放射能の強さの予測値Ｎを適宜表示する。
【００５９】
次に、図１、図２及び図４を参照して、本実施形態に係る標識化合物製造装置１００の作用について説明する。
【００６０】
まず、カートリッジ１５に、試薬の入った容器１０６，１３２をセットする。
【００６１】
次に、オペレータがこのカートリッジを本体部１０にセットする。
【００６２】
続いて、オペレータがサイクロトロン等において生成された^１８Ｆイオンを含むターゲット水を所定量カートリッジ１５のターゲット水リザーバ１０１に貯留する。これで、製造の前処理が完了する。
【００６３】
ここで、放射能予測装置７０は、ターゲット水リザーバ１０１からの放射線の量を検出してターゲット水リザーバ１０１内の放射能の強さＮ_１を取得し、さらに、標準収率ε_１と今から製造工程を始めたとする場合に要する時間Ｔ_ａｌｌとを各々取得し、（１）式に基づいて、製造工程の終了時に得られるＦＤＧの放射能の強さの予測値Ｎ_{ｐｒｅｄ１}を求め表示器７６に表示する。
【００６４】
ここで、放射性同位元素である^１８Ｆは、半減期が１１０分と短く、ターゲット水をターゲット水リザーバ１０１に導入した直後から、ターゲット水リザーバ１０１内の放射能の強さＮ_１は減衰する。この様子を図４に示す。
【００６５】
そして、放射能予測装置７０は、所定の時間毎にターゲット水リザーバ１０１からの放射線を検出して放射能の強さＮ_１を取得し、その時点で製造操作が開始されたとした場合に製造終了後に得られるＦＤＧの放射能の強さの予測値Ｎ_{ｐｒｅｄ１}を取得し、表示する。
【００６６】
次に、オペレータがコンソール４０の製造開始のボタンを押すと、製造工程が開始される。この時刻が、図４におけるｔ_ｓである。なお、この製造工程は制御ユニット３０によって自動的に制御される。この標識化合物製造装置１００における製造工程は主として、ＦＤＧ前駆体を製造する工程と、これに続くＦＤＧ前駆体を加水分解する工程とを含んでいる。
【００６７】
まず、シリンジ駆動機構Ｓ３の駆動によってターゲット水リザーバ１０１からシリンジ１０２に^１８Ｆイオンを含むターゲット水を所定量吸引する。これによって、図４に示すように、ターゲット水リザーバ１０１内からの放射能の強さＮ_１は減少する。
【００６８】
次に、シリンジ駆動機構Ｓ３の駆動によって、シリンジ１０２内のターゲット水を固相抽出カラム１０３に徐々に供給する。固相抽出カラム１０３においては、ターゲット水中の^１８Ｆイオンがイオン交換反応により固相抽出カラム１０３に固定される一方、^１８Ｏを主成分とする残りの成分は固相抽出カラム１０３を通過して図示しない排液だめに回収される。
【００６９】
このとき、固相抽出カラム１０３に^１８Ｆイオンが固定されるため、図４に示すように、固相抽出カラム１０３の放射能の強さＮ_２が増加し、ある時刻ｔ_２ｍａｘを取得で最大値Ｎ_２ｍａｘとなり、これ以降、放射性崩壊等に伴って徐々に減衰していくこととなる。
【００７０】
ここで、放射能予測装置７０は、固相抽出カラム１０３からの放射能量が最大値Ｎ_２ｍａｘを記録したのち、この固相抽出カラム１０３の放射能の強さＮ_２と標準収率ε_２とに基づいて、製造工程終了時のＦＤＧの放射能の強さの予測値Ｎ_{ｐｒｅｄ２}を取得し表示する。
【００７１】
次に、シリンジ駆動機構Ｓ１の駆動によって容器１０６内のトリフレートを固相抽出カラム１０３内に導入する。これによって、ＦＤＧ前駆物質（アセチル化ＦＤＧ）が生成し、生成したＦＤＧ前駆物質前駆体は、加水分解容器１１０へ流入する。
【００７２】
この操作においては、図４に示すように、加水分解容器１１０内にＦＤＧ前駆物質が流入するために加水分解容器１１０内の放射能の強さが増加し、ある時刻ｔ_３ｍａｘで最大値Ｎ_３ｍａｘとなり、これ以降、放射性崩壊等に伴って放射能の強さは徐々に減衰していくこととなる。
【００７３】
そして、放射能予測装置７０は、加水分解容器１１０からの放射能量が最大値Ｎ_３ｍａｘを記録したのち、この加水分解容器１１０の放射能の強さＮ_３と標準収率ε_３に基づいて、製造工程終了後のＦＤＧの放射能の強さの予測値Ｎ_{ｐｒｅｄ３}を取得する。
【００７４】
なお、ここでは、固相抽出カラム１０３にＦＤＧ前駆物質がなるべく残らないように、純水等によってリンスを行って、固相抽出カラム１０３内のＦＤＧ前駆物質を効率よく加水分解容器１１０に導入する。
【００７５】
その後、シリンジ駆動機構Ｓ４の駆動によって容器１３２内の加水分解用の反応液を加水分解容器１１０内に導入する。これにより、ＦＤＧ前駆物質が加水分解され、ＦＤＧが生成する。
【００７６】
この操作において、図４に示すように、加水分解容器の放射能の強さＮ_３は、主として自発的な放射性崩壊によって減衰して行く。ここで、予測値Ｎ_{ｐｒｅｄ３}は所定時間毎に取得されるが、不具合がなければその値はほとんど変わらない。
【００７７】
次に、図２において、シリンジ駆動機構Ｓ６の駆動により加水分解容器１１０内のＦＤＧを含む混合物をシリンジ１２０内に吸引する。その後、シリンジ駆動機構Ｓ６の駆動により、シリンジ１２０内のＦＤＧを含む混合物を第一精製カラム１４０、第二精製カラム１５０を順次通過させ、ＦＤＧを精製させる。そして、精製されたＦＤＧを製品コンテナ２０に導入し、一連の製造工程を終了する。
【００７８】
そして、標準収率ε_１〜ε_３が適切に設定されており、各処理において不具合がなければ製造工程終了後に製品コンテナ２０内にあるＦＤＧの放射能の強さＮは、各過程で予測された予測値のＮ_{ｐｒｅｄ１}、Ｎ_{ｐｒｅｄ２}、Ｎ_{ｐｒｅｄ３}とほぼ同じとなる。
【００７９】
次に、製造工程において、^１８Ｆの収率が悪化するような不具合が起こった場合の作用について説明する。
【００８０】
例えば、固相抽出カラム１０３で固定された^１８Ｆが十分に加水分解容器１１０内に移送されなかった場合は、図５に示すように、加水分解容器１１０内の放射能の強さＮ_３の値、例えば、ｔ_３ｍａｘ時のＮ_３ｍａｘ等、が正常な場合に比して低くなる。このため、ｔ_３ｍａｘ以降に取得される製造後のＦＤＧの放射能の強さの予測値Ｎ_{ｐｒｅｄ３}は、ｔ_３ｍａｘよりも前に取得されていた予測値Ｎ_{Ｐｒｅｄ１}やＮ_{ｐｒｅｄ２}よりも低くなる。そして、この低くなったＮ_{ｐｒｅｄ３}は、不具合によって減少した加水分解容器１１０内の放射能の強さに応じたものであり、製造工程終了後に得られるＦＤＧの放射能の強さＮとほぼ同じとなる。このため、オペレータは、放射能予測装置７０によって、製造工程の途中で製造後に得られるＦＤＧの放射能の強さＮが予定よりも低くなること、さらに、どの程度低くなるかを予想できる。
【００８１】
また、例えば、図６に示すように、加水分解容器１１０内での加水分解処理中で正常にｔ_３ｍａｘを迎えた後の時刻ｔ_１０に不具合が起きた場合等には、加水分解容器１１０内の放射能の強さＮ_３がその時刻ｔ_１０から正常な場合よりも低いＮ_{３ｄｏｗｎ}となる。そして、製造終了後に得られるＦＤＧの放射能の強さＮも、図に示すように、正常な場合に比べて低くなる。
【００８２】
この場合も、放射能予測装置７０によって、このような低くなったＮ_{３ｄｏｗｎ}に基づいて、正常な場合よりも低い製造工程終了後のＦＤＧの放射能の強さの予測値Ｎ_{ｐｒｅｄ３ｂ}が取得され、表示されることとなる。このため、オペレータは、製造工程が終了する前に、製造終了後に得られるＦＤＧの放射能の強さの予測値を取得することができる。
【００８３】
以上説明したように、本実施形態においては、製造工程（所定の処理）の途中に固相抽出カラム１０３や加水分解容器１１０内から放射される放射線の量が取得され、これに基づいて製造工程完了後に得られるＦＤＧの放射能の強さの予測値を製造工程の途中に得ている。このため、製造工程の途中において固相抽出カラム１０３や加水分解容器１１０内から^１８Ｆが系外へ飛散したりする等の不具合が起こった場合でも、最終的に製造されるＦＤＧの放射能の強さの予測値がその不具合に応じて製造工程中に把握できる。このため、このような不具合がおきた場合において、臨床スケジュールの変更や標識化合物の再製造等の準備を迅速に行える。
【００８４】
また、放射能取得部７８ａが放射線の量に関する情報に基づいて反応器具内の放射能の強さに関する情報を取得するので、放射能予測値取得手段は、所定の器具内の放射能の強さに関する情報に基づいて所定の処理によって製造される標識化合物の放射能の強さの予測値を好適に予測できている。
【００８５】
また、放射線の量が取得された時刻から製造工程が終了するまでに要する残時間を取得しているので、放射線の量が取得された時刻から製造工程が終了するまでに自然崩壊によって放射能が減衰する分を考慮に入れた上で、精度よく製造されるＦＤＧの放射能の強さが予測されている。
【００８６】
また、各反応容器内でのＦＤＧの製造収率が予め格納された標準収率格納部７８ｄを備えており、各反応容器内での製造効率に基づいて、ＦＤＧの放射能の強さの予測値をより高い精度で得ることができている。
【００８７】
また、比較的長時間の処理が必要とされると共に放射性同位元素の飛散等の不具合が生じやすい固相抽出カラム１０３や加水分解容器１１０内からの放射線の量を測定しているため、不具合が起こったことを直ちに検出でき、ＦＤＧの放射能の強さの予測値の減少を迅速に取得することができている。
【００８８】
また、ターゲット水リザーバ１０１内からの放射線の量を取得しており、製造工程を始める前にも、製造後のＦＤＧの放射能の予測値を取得できている。
【００８９】
また、向きや大きさが好適に設定された遮蔽板７１の貫通孔７１ａ〜７１ｃを介して放射線検出器７３〜７５が放射線を検出しているので、他の器具等の放射線源からのノイズを十分に低減して、目的とする器具からの放射線の量を精度よく取得することができている。
【００９０】
（第二実施形態）
次に、本発明の第二実施形態について説明する。
【００９１】
図７は、第二実施形態に係る標識化合物製造装置２００である。本実施形態の標識化合物製造装置２００は、^１８Ｆイオンを含む水溶液やトリフレート等を原料として、標識化合物としてのＦＤＧを第一実施形態とは異なる工程で製造するものである。この標識化合物製造装置２００が、第一実施形態に係る標識化合物製造装置１００と異なる主な点は、一回の製造操作毎に取り替えるカートリッジを用いずに固定された配管系統を用いる点と、配管系統のバルブ等を制御すると共にさらに製造されるＦＤＧの放射能の強さの予測値Ｎ_ｐｒｅｄを取得する総合制御装置１７８を備えている点と、である。
【００９２】
以下、この標識化合物製造装置２００について詳細に説明する。標識化合物製造装置２００は、製造に必要な種々の反応等の処理を行う本体部２１２と、本体部２１２で製造されたＦＤＧが導入される製品コンテナ２０と、本体部２１２を制御すると共に生成されるＦＤＧの放射能の強さの予測値Ｎ_ｐｒｅｄを取得する総合制御装置１７８と、オペレータからの指示が入力されると共に総合制御装置１７８からの指示が出力されるコンソール４０と、総合制御装置１７８からのデータが出力されるプリンタ５０と、総合制御装置１７８からのデータをオペレータに表示する表示器７６と、を備えている。
【００９３】
本体部２１２は、主として、^１８Ｆイオンを含むターゲット水が予め導入されるターゲット水リザーバ２０１と、ターゲット水リザーバ２０１からのターゲット水が供給され当該ターゲット水中の^１８Ｆイオンを固定する固相抽出カラム（反応容器）２０３と、固定された^１８Ｆイオンとトリフレートとを反応させてＦＤＧ前駆体を生成させると共に、生成されたＦＤＧ前駆体を加水分解を起こさせる加水分解反応液により加水分解させて目的標識化合物であるＦＤＧを得るための加水分解容器（反応容器）２１０と、加水分解容器２１０で製造されたＦＤＧを精製するための精製カラム２７５と、を備えている。
【００９４】
また、固相抽出カラム２０３の上流側には、反応触媒を貯留する容器２２１と、遊離液を貯留する容器２２３と、が各々接続されている。
また、固相抽出カラム２０３の下流側には、ターゲット水の排液を受ける容器２２５が接続されている。
【００９５】
加水分解容器２１０は、縦長状の容器である。
また、加水分解容器２１０より下流側には精製カラム２７５が接続され、精製カラム２７５の下流側には製品コンテナ２０が接続されている。
【００９６】
精製カラム２７５は、固相抽出用のＣ１８カラムや中性アルミナカラム等であり、ＦＤＧから着色物質や未加水分解物等を除去するものである。
【００９７】
また、加水分解容器２１０には、トリフレートを貯留する容器２２７と、加水分解反応を起こさせる加水分解反応液を貯留する容器２３１と、加水分解容器２１０や精製カラム２７５をリンスするための水が貯留される容器２３３と、が接続されている。
【００９８】
さらに、本体部２１２は、ヒータＨ３を有し、加水分解容器２１０を加熱することができる。
【００９９】
また、本体部２１２には、ターゲット水リザーバ１０１からの放射線を検出するリザーバ放射線検出器７３と、固相抽出カラム２０３からの放射線を検出する反応容器放射線検出器７４と、加水分解容器２１０からの放射線を検出する反応容器放射線検出器７５と、が設置されている。これらの放射線検出器７３〜７５の構成は第一実施形態と同様である。
【０１００】
総合制御装置１７８は、制御ユニット１３０と、放射能取得部７８ａ、残り時間取得部７８ｂ、放射能予測値演算部７８ｃ、標準収率格納部７８ｄ、を有している。
【０１０１】
制御ユニット１３０は、オペレータの操作によってコンソールスイッチ４０からの製造開始の合図が入力されると、予め定められた順序やタイミングで、上述の本体部２１２の制御を行う。
【０１０２】
また、放射能取得部７８ａ、残り時間取得部７８ｂ、標準収率格納部７８ｄ、放射能予測値演算部７８ｃ、及び、放射能予測値演算部７８ｃの機能や構成等は第一実施形態と同様である。
【０１０３】
本実施形態では、リザーバ放射線検出器７３、反応容器放射線検出器７４，７５、放射能取得部７８ａ、残り時間取得部７８ｂ、標準収率格納部７８ｄ、及び、放射能予測値演算部７８ｃが放射能予測装置２７０を構成している。また、リザーバ放射線検出器７３と放射能取得部７８ａがリザーバ内放射能取得手段８０を構成している。
【０１０４】
表示器７６は、放射能予測値演算部７８ｃが予測した放射能の強さの予測値Ｎ_ｐｒｅｄや、制御ユニット１３０によって制御されている本体部２１２の状況等を適宜表示する。
【０１０５】
次に、本実施形態に係る標識化合物製造装置２００の作用について説明する。
【０１０６】
まず、容器２２３には遊離液を、ターゲット水リザーバ２０１にはサイクロトロン等で得られた^１８Ｆイオンを含むターゲット水を、容器２２１には反応触媒を、容器２２７にはトリフレートを、容器２３３には水を、容器２３１には加水分解反応液を予め導入しておく。
【０１０７】
次に、オペレータがコンソール４０の製造開始ボタンを押すことにより、ＦＤＧ製造工程が開始される。
【０１０８】
この標識化合物製造装置２００における製造工程は主として、ターゲット水から^１８Ｆイオンを抽出する工程と、抽出された^１８Ｆイオンを含むＦＤＧ前駆体を生成しこれを加水分解する工程と、を含んでおり、これらを含む工程は、総合制御装置１７８の制御ユニット１３０により自動的に行われる。
【０１０９】
まず、ターゲット水リザーバ２０１内のターゲット水を固相抽出カラム２０３に供給する。固相抽出カラム２０３においては、ターゲット水中の^１８Ｆイオンがイオン交換反応により固相抽出カラム２０３に固定される一方、^１８Ｏを主成分とする残りの成分は固相抽出カラム２０３を通過して容器２２５に回収される。なお、このようにして容器２２５に回収された^１８Ｏを含む水は再びサイクロトロンでの^１８Ｆイオンの製造等に再利用される。
【０１１０】
次に、容器２２３の遊離液を、固相抽出カラム２０３内に供給し、固相抽出カラム２０３に固定されていた^１８Ｆイオンを溶出する。そして、溶出された^１８Ｆイオンを含む炭酸カルシウム水溶液を加水分解容器２１０に導入する。つづいて、容器２２１内の反応触媒を固相抽出カラム２０３を介して加水分解容器２１０に導入する。
【０１１１】
次に、加水分解容器２１０内の水と有機溶媒とを蒸発させて取り除く。
その後、容器２２７内のトリフレートを加水分解容器２１０内に導入し、トリフレートのフッ素化反応を行いＦＤＧ前駆物質（アセチル化ＦＤＧ）を生成させる。
【０１１２】
その後、加水分解容器２１０内を加熱して溶媒を除去した後、容器２３１内から加水分解用の反応液を投入し、加水分解容器２１０内のＦＤＧ前駆物質を加水分解させる。
【０１１３】
その後、加水分解容器２１０内のＦＤＧを精製カラム２７５に導入して精製し、精製されたＦＤＧを製品コンテナ２０に投入させる。
【０１１４】
最後に、容器２３３から蒸留水を加水分解容器２１０と、精製カラム２７５とに供給してリンスを行い、リンス液を製品コンテナ２０に導入して製造工程を終了する。
【０１１５】
この一連の製造工程においては、第一実施形態と同様にして、ターゲット水リザーバ２０１や固相抽出カラム２０３や加水分解容器２１０内の放射能の強さが取得され前述の（１）式に基づいて製造工程終了後のＦＤＧの放射能の強さＮ_{ｐｒｅｄ１}、Ｎ_{ｐｒｅｄ２}、Ｎ_{ｐｒｅｄ３}、が求められ、表示器７６に表示される。これによって、第一実施形態と同様の作用効果を奏する。
【０１１６】
ここでは、一例として、^１８Ｆイオンが加水分解容器２１０に導入された後に、加水分解容器２１０から放射される放射線に基づいて予測値Ｎ_ｐｒｅｄが取得される場合について説明する。
【０１１７】
図８は、加水分解容器２１０内の放射能の強さＮ_３の変化を示すグラフである。
【０１１８】
時刻ｔ_２０１の時点において、炭酸カルシウムによって溶出された_１８Ｆイオンが固相抽出カラム２０３側から流入すると放射能の強さが上昇し、ｔ_３ｍａｘで放射能の強さが最大値Ｎ_３ｍａｘになる。そして、このとき、製造されるＦＤＧの放射能の強さの予測値Ｎ_{ｐｒｅｄ３}が取得され表示されるので、固相抽出カラム２０３からの^１８Ｆイオンの溶出に不具合があるか否かがわかり、不具合のある場合の予測値Ｎ_ｐｒｅｄも直ちに把握される。
【０１１９】
また、所定時間毎に、放射能の予測値Ｎ_{ｐｒｅｄ３}が繰り返し取得されるので、例えばｔ_２０２付近で加水分解容器を加熱している際に、^１８Ｆがガスとして系外に排出される等の不具合がある場合に、ＦＤＧ製造工程の完了後に放射能が減ることがすぐに把握される。
【０１２０】
同様にして、加水分解が終了し、加水分解容器２１０からＦＤＧが排出される直前のｔ_２０３にも放射能の予測値Ｎ_{ｐｒｅｄ３}が得られ、製造されるＦＤＧの放射能の強さが精度良く予想される。
【０１２１】
本発明は、上記実施形態に限定されるものではなく、種々の変形態様をとることが可能である。
【０１２２】
例えば、上記実施形態では、標識化合物としてＰＥＴ（Ｐｏｓｉｔｒｏｎ Ｅｍｉｓｓｉｏｎ Ｔｏｍｏｇｒａｐｈｙ）測定用に用いられる^１８Ｆを含むＦＤＧを製造しているが、他の標識化合物を製造しても良い。
【０１２３】
例えば、^１８Ｆを含む標識化合物としては、ＦＰＡＭＴ（^１８Ｆ標識−プロピルアフファメチルタイロシン）が挙げられる。また、他の放射性同位元素を含むＰＥＴ測定用の標識化合物としては、^１１Ｃを含む酢酸、^１３Ｎを含むアンモニア，^１５Ｏを含む水等が挙げられる。
【０１２４】
また、ＳＰＥＣＴ（Ｓｉｎｇｌｅ Ｐｈｏｔｏｎ Ｅｍｉｓｓｉｏｎ Ｔｏｍｏｇｒａｐｈｙ）測定用の標識化合物等でもよく、例えば、^６７Ｇａ、^２０１Ｔｌ、^１２３Ｉを含む標識化合物が挙げられる。
【０１２５】
また、上記実施形態では、残り時間取得部７８ｂを備え、これに基づいて、製造工程終了時のＦＤＧの放射能の強さの予測値を取得しているがこれに限られない。例えば、図１及び図７に示すように、製造工程が行われる過程での反応容器内の放射能の強さに関する情報についての基準データが予め格納された標準トレンド格納部（基準データ格納手段）９０を備え、放射能予測値演算部７８ｃは、放射能取得部７８ａにより取得された放射能の強さと、標準トレンド格納部９０に格納された放射能の強さの基準データと、の比較に基づいて、製造されるＦＤＧの放射能の強さの予測値を取得してもよい。例えば、基準データからのずれに対応して放射能の強さの予測値を低下させるようにすればよい。
【０１２６】
また、上記実施形態では、反応容器である固相抽出カラム１０３や加水分解容器１１０内から放射される放射線の量を測定しているが、放射性同位元素を含む物質が通るライン等、標識化合物を製造する処理の過程で所定の処理が行われる他の器具（所定の器具に対応）から放射される放射線の量を測定しても良い。例えば、第一実施形態においては、ターゲット水リザーバ１０１と固相抽出カラム１０３との間のライン、シリンジ１０２、固相抽出カラム１０３と加水分解容器１１０との間のライン、固相抽出カラム１０３と精製カラム１４０との間のライン、精製カラム１４０，１５０等の内部から放射される放射線の量を測定することができる。
【０１２７】
また、上記実施形態では、全てコンピュータで自動的に放射能の強さの予測を行っているが、放射能の強さの予測までを装置で自動的に行い、予測値の取得はオペレータ等が行っても良い。
【０１２８】
【発明の効果】
本発明によれば、所定の処理の途中にこの所定の器具内から放射される放射線の量に関する情報を取得し、これに基づいて所定の処理の完了後に得られる標識化合物の放射能の強さの予測値を所定の処理の途中に得る。このため、所定の処理の途中において器具内から放射性同位元素が系外へ飛散したりする等の不具合が起こった場合でも、最終的に得られる標識化合物の放射能の強さの予測値がその不具合に応じて所定の処理中に把握できる。このため、このような不具合がおきた場合において、臨床スケジュールの変更や標識化合物の再製造等の準備を迅速に行える。
【図面の簡単な説明】
【図１】第一実施形態に係る標識化合物製造装置を示す概略図である。
【図２】図１中の本体部の一部破断正面図である。
【図３】図１のＩＩＩ−ＩＩＩ線に沿った概略断面図である。
【図４】ＦＤＧ製造の処理中に図１の放射能取得部が取得するリザーバタンク、固相抽出カラム及び加水分解容器内の放射能の強さの経時変化を各々示す第１のグラフである。
【図５】ＦＤＧ製造の処理中に図１の放射能取得部が取得するリザーバタンク、固相抽出カラム及び加水分解容器内の放射能の強さの経時変化を各々示す第２のグラフである。
【図６】ＦＤＧ製造の処理中に図１の放射能取得部が取得するリザーバタンク、固相抽出カラム及び加水分解容器内の放射能の強さの経時変化を各々示す第３のグラフである。
【図７】第二実施形態に係る標識化合物製造装置を示す概略図である。
【図８】ＦＤＧ製造の処理中に図７の放射能取得部が取得する加水分解容器内の放射能の強さの経時変化を示すグラフである。
【符号の説明】
１００，２００…標識化合物製造装置、７０，２７０…放射能予測装置、７１…遮蔽板（遮蔽部材）、７４，７５…反応容器放射線検出器（器具放射線検出手段）、７８ａ…放射能取得部（器具放射能取得手段）、７８ｂ…残り時間取得部（残時間取得手段）、７８ｃ…放射能予測値演算部（放射能予測値取得手段）、７８ｄ…標準収率格納部（収率格納手段）、８０…リザーバ内放射能取得手段、９０…標準トレンド格納部（基準データ格納手段）、１０１…リザーバタンク（リザーバ）、１０３，２０３…固相抽出カラム（反応容器）、１１０，２１０…加水分解容器（反応容器）。[0001]
TECHNICAL FIELD OF THE INVENTION
The present invention relates to a radioactivity prediction apparatus and a radioactivity prediction method for obtaining a predicted value of the radioactivity intensity of a labeled compound obtained after production when producing a labeled compound containing a radioisotope, and a label using the same. The present invention relates to a compound manufacturing apparatus.
[0002]
[Prior art]
2. Description of the Related Art Conventionally, there has been known an apparatus for producing a labeled compound which performs a treatment such as a predetermined reaction in a prescribed instrument to produce a labeled compound containing a radioisotope. For example, used for PET measurement ¹⁸ A labeled compound producing apparatus for producing F-FDG (2-fluoro-2-deoxy-D-glucose, hereinafter referred to as FDG) includes, for example, ¹⁸ A reservoir in which an aqueous solution containing target ions such as F is stored in advance; and the aqueous solution is introduced from the reservoir and ¹⁸ F ion was extracted and extracted by ion exchange reaction. ¹⁸ An extraction column for reacting F ions with triflate to produce an FDG precursor, and a hydrolysis vessel for introducing the produced FDG precursor and hydrolyzing it with an acid or alkali to produce FDG, (See Non-Patent Document 1).
[Non-patent document 1]
General Electric Company, "Product Data S9120 JF / JG / JH / JJ PETtrace ^TM FDG MicroLab ", USA, Nov, 1997.
[0003]
[Problems to be solved by the invention]
In such a labeled compound producing apparatus, in an extraction column or in various treatments in a hydrolysis vessel reaction, a substance containing a radioisotope may be discharged out of the system due to a defect. Radioactivity may be lower than expected. If the intensity of the radioactivity of the labeled compound is less than expected, a clinical schedule using the labeled compound may be hindered.
[0004]
The present invention has been made in view of the above problems, and has been made in consideration of the above-mentioned problems, and a radioactivity prediction apparatus, a radioactivity prediction method, and a radioactivity prediction method for predicting the intensity of radioactivity of a labeled compound obtained after completion of production, It is intended to provide a device.
[0005]
[Means for Solving the Problems]
The radioactivity prediction apparatus according to the present invention, when producing a labeled compound containing a radioisotope by performing a predetermined treatment in a predetermined instrument, the radioactivity of the labeled compound obtained after the completion of the predetermined treatment A radiation predicting apparatus for obtaining a predicted value of the radiation, wherein the apparatus radiation detecting means for acquiring information on the amount of radiation emitted from within a predetermined instrument during a predetermined process, and the instrument radiation detecting means Radioactivity prediction value obtaining means for obtaining a predicted value of the radioactivity intensity of the labeled compound obtained after completion of the predetermined process, based on information on the amount of radiation emitted from within the predetermined device. It is characterized by.
[0006]
Further, the radioactivity prediction method according to the present invention, when producing a labeled compound containing a radioisotope by performing a predetermined process in a predetermined instrument, the radioactivity of the labeled compound obtained after the completion of the predetermined process Radioactivity prediction method for obtaining a predicted value of the intensity of the instrument, the instrument radiation detection step of obtaining information on the amount of radiation emitted from within a given instrument during a given process, and the instrument radiation detection step A radioactivity predicted value obtaining step of obtaining a predicted value of the radioactivity intensity of the labeled compound obtained after the completion of the predetermined process, based on the information on the amount of radiation emitted from within the predetermined device. It is characterized by including.
[0007]
According to these inventions, information on the amount of radiation radiated from within a predetermined instrument during predetermined processing is obtained, and based on this, the intensity of the radioactivity of the labeled compound obtained after completion of the predetermined processing Can be obtained during predetermined processing. For this reason, even if a problem such as the radioisotope being scattered from the inside of the instrument to the outside of the system during the predetermined treatment occurs, the predicted value of the radioactivity intensity of the finally obtained labeled compound is not It can be grasped during a predetermined process according to a defect. Therefore, when such a problem occurs, preparation for changing the clinical schedule, remanufacturing the labeled compound, and the like can be quickly performed.
[0008]
Here, the apparatus includes appliance radioactivity acquisition means for acquiring information about the intensity of radioactivity in a predetermined appliance based on information about the amount of radiation acquired by the appliance radiation detection means, and the radioactivity prediction value acquisition means includes: Preferably, a predicted value of the radioactivity intensity of the labeled compound is predicted based on information on the radioactivity intensity in a given device.
[0009]
According to this, since information on the intensity of the radioactivity in the instrument is obtained during the predetermined processing, the predicted value of the intensity of the radioactivity of the labeled compound to be produced can be appropriately predicted.
[0010]
The apparatus further includes a remaining time obtaining unit configured to obtain a remaining time from a time at which the information regarding the amount of radiation is obtained by the instrument radiation detecting unit to a time at which the predetermined process is to be completed. It is preferable to obtain a predicted value of the radioactivity of the labeled compound based on the remaining time.
[0011]
According to this, further, the remaining time required from the time when the information regarding the amount of radiation is obtained to the end of the predetermined process is obtained, and the predetermined process ends from the time when the information regarding the amount of radiation is obtained. By taking into account the amount of radioactivity attenuated by spontaneous decay, it is possible to obtain a predicted value of the radioactivity intensity of the labeled compound produced with high accuracy.
[0012]
The apparatus further includes a reference data storage unit in which reference data on information on the amount of radiation emitted from the inside of the instrument in the process of performing the predetermined process is stored in advance, and the radioactivity predicted value acquiring unit includes an instrument radiation detecting unit. Based on a comparison between the information about the amount of radiation obtained by the reference and the reference data of the information about the amount of radiation stored in the reference data storage unit, a predicted value of the radioactivity intensity of the labeled compound is obtained. Is also good.
[0013]
According to this, by comparing the reference value regarding the amount of radiation from inside the device with the actually measured value of the amount of radiation actually emitted from inside the device, the intensity of the radioactivity of the labeled compound after completion of the predetermined step is determined. Prediction can be suitably performed.
[0014]
The apparatus further comprises a yield storage unit in which the production yield of the labeled compound in the device is stored in advance, and the radioactivity predicted value obtaining unit further includes a radioactivity estimation device for the labeled compound based on the production yield in the device. It is preferable to obtain a predicted value of the strength of
[0015]
According to this, it is possible to obtain a more accurate radioactivity intensity acquisition value in consideration of the production yield in the instrument.
[0016]
Further, it is preferable that the predetermined tool includes a reaction vessel in which a chemical reaction is performed, and the tool radiation detecting means obtains information on the amount of radiation emitted from the inside of the reaction vessel.
[0017]
In such a reaction vessel, a relatively long-time treatment is required, and inconveniences such as scattering of radioisotopes are apt to occur. For this reason, by acquiring the radiation dose from such a reaction vessel, it is possible to immediately detect that a failure has occurred, and to quickly acquire a decrease in the predicted value of the radioactivity of the labeled compound.
[0018]
Further, the reaction vessel is provided with an aqueous solution containing a radioisotope, an extraction column for extracting the radioisotope from the aqueous solution by an ion exchange reaction, and a precursor containing the radioisotope extracted by the extraction column with an acid or alkali. A hydrolysis vessel that decomposes to produce a labeled compound, and wherein the instrument radiation detection means has information about the amount of radiation emitted from within the extraction column and information about the amount of radiation emitted from within the hydrolysis vessel. , Respectively.
[0019]
According to this, a radioisotope is extracted from an aqueous solution containing a radioisotope as a raw material by an extraction column, and a labeled compound precursor containing the radioisotope is generated and then hydrolyzed in a hydrolysis apparatus. When producing labeled compounds, the radioactivity of radioisotopes extracted in the extraction column and the radioactivity of radioisotopes in the hydrolysis device can be obtained, and radioisotopes that were not successfully extracted into the extraction column In consideration of the amount of the compound, the radioisotope that has not reached the hydrolysis apparatus, and the like, the predicted value of the radioactivity of the labeled compound after the production can be suitably obtained.
[0020]
Further, it is preferable to include a reservoir radiation detecting means for acquiring information on the amount of radiation radiated from the reservoir in which the raw material containing the radioactive substance to be introduced into the predetermined instrument is stored.
[0021]
According to this, the intensity of the radioactivity in the reservoir can be obtained, and further, a predicted value of the radioactivity of the labeled compound after production can be obtained before performing a predetermined process.
[0022]
In addition, the device has a shielding member formed of lead and facing a predetermined device and having a through hole facing the predetermined device, and the device radiation detecting means radiates from the inside of the device through the through hole of the shielding member. It is preferable to detect the radiation that is emitted.
[0023]
According to this, by appropriately setting the direction and size of the through-hole, noise from other radiation sources is sufficiently reduced, and information on the amount of radiation from the intended instrument is acquired with high accuracy. be able to.
[0024]
Further, an apparatus for producing a labeled compound according to the present invention includes the above-described radioactivity prediction apparatus and an instrument in which a predetermined process is performed.
[0025]
BEST MODE FOR CARRYING OUT THE INVENTION
Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the description of the drawings, the same or corresponding elements have the same reference characters allotted, and overlapping description will be omitted.
[0026]
(First embodiment)
FIG. 1 is an apparatus 100 for producing a labeled compound according to the first embodiment. The labeled compound producing apparatus 100 of the present embodiment includes: ¹⁸ An aqueous solution containing F ions or triflate as a raw material ¹⁸ It is for producing F-FDG (2-fluoro-2-deoxy-D-glucose, hereinafter simply referred to as FDG). The labeled compound manufacturing apparatus 100 includes a main body 10 for performing various processes such as reactions required for the manufacture, a product container 20 into which the FDG manufactured by the main body 10 is introduced, and a control unit for controlling the main body 10. 30, a console 40 to which an instruction from the operator is input and an instruction from the control unit 30 are output, a printer 50 to output data from the control unit 30, and the intensity of radioactivity of the FDG to be manufactured And a radioactivity prediction device 70 that predicts
[0027]
The main body 10 has a box-shaped housing, and a cartridge 15 is detachable on one side surface thereof. The cartridge 15 includes various containers in which raw materials and the like necessary for the production of FDG are stored, reaction containers such as a solid phase extraction column 103 and a hydrolysis container 110 required in the production process, and a container between these reaction containers. Are connected to a new one every time the FDG is manufactured, and the FDG can be manufactured in a clean state at all times. Then, the main body 10 performs various processes on the cartridge 15 according to an instruction from the control unit 30, and automatically manufactures the FDG.
[0028]
Here, the cartridge 15 will be described in detail.
[0029]
The cartridge 15 mainly includes, as shown in FIG. ¹⁸ Target water reservoir 101 into which target water containing F ions is introduced in advance, target water from target water reservoir 101 is supplied, and ¹⁸ Fixed and fixed F ions ¹⁸ F ion and triflate (1,3,4,6-tetra-O-acetyl-2-O-trifluoromethanesulfonyl-β-D-manopyranose, 1,3,4,6-tetra-O-acetyl-2 FDG precursor (1,3,4,6-tetra-O-acetyl-2-fluoro-2-deoxy-β-D (+)) by reacting with -O-trifluoromethanesulfonyl-β-D-manno-pyranose Solid phase extraction column (reaction vessel) 103 for producing glucose, 1,3,4,6, -tetra-O-acetyl-2-fluoro-2-deoxy-β-D (+)-Glucose) Hydrolyzing the FDG precursor generated in the solid phase extraction column 103 with an aqueous HCl solution to obtain FDG which is the target labeling compound Solution container is provided with a (reaction vessel) 110, a.
[0030]
Further, it has a container 106 for storing triflate and a container 132 for storing a reaction solution for hydrolysis.
[0031]
A syringe 102 is connected between the target water reservoir 101 and the solid-phase extraction column 103, and a syringe 102 that sucks a predetermined amount of target water from the target water reservoir 101 and discharges the target water toward the solid-phase extraction column 103 is provided. The syringe 102 is driven by the syringe drive mechanism S3.
[0032]
In addition, a syringe 107 that discharges the triflate of the container 106 toward the solid-phase extraction column 103 is connected between the container 106 in which the triflate is stored and the solid-phase extraction column 103. Driven by the syringe drive mechanism S1.
[0033]
Further, a syringe 134 for discharging the hydrolysis reaction solution in the container 132 into the hydrolysis container 110 is connected between the container 132 in which the hydrolysis reaction solution is stored and the hydrolysis container 110, This syringe 134 is driven by the syringe drive mechanism S4.
[0034]
Further, a first purification column 140 for purifying FDG generated in the hydrolysis container 110 is connected to the hydrolysis container 110, and a second purification column 140 for purifying FDG is also connected to the first purification column 140. The purification column 150 is connected.
[0035]
A syringe 120 for discharging the liquid in the hydrolysis container 110 toward the first purification column 140 is connected between the hydrolysis container 110 and the first purification column 140, and the syringe 120 is connected to the syringe driving mechanism S6. Driven by
The cartridge 15 is detachably fixed to the main body 10.
[0036]
As shown in FIGS. 1 and 2, the main body 10 has a cover 10 a that covers the cartridge 15.
[0037]
The control unit 30 is connected to the main body unit 10 and automatically performs an FDG manufacturing operation, for example, an operation of the syringe S1 or the like, in a predetermined order or timing when an operator starts the console switch 40. Do it.
[0038]
As shown in FIG. 1, the radioactivity prediction device 70 according to the present embodiment includes a lead shielding plate (shielding member) 71 having a plurality of predetermined through holes formed therein, and a reservoir installed on the shielding plate 71. A radiation detector 73, reaction vessel radiation detectors (instrument radiation detection means) 74 and 75 also installed on the shielding plate 71, a computer device 78 to which these radiation detectors 73 to 75 are connected, and a computer device 78. And a display 76 for displaying the result obtained by the above.
[0039]
As shown in FIGS. 1 and 3, the shielding plate 71 is provided on the cover 10 a of the main body 10 so as to be detachable from the cover 10 a. The shielding plate 71 is a flat plate opposed to the target water reservoir 101, the solid-phase extraction column 103, and the hydrolysis vessel 110 of the cartridge 15 via the cover 10a, and has a thickness capable of shielding radiation from the cartridge 15. It is said.
[0040]
In the shielding plate 71, through holes 71a, 71b, 71c penetrating in the thickness direction of the shielding plate 71 are formed. The opening position and the hole diameter of the through-hole 71a are such that the radiation from the target water reservoir 101 passes through the shielding plate 71 on the opposite side to the cartridge 15, while the radiation from the solid-phase extraction column 103 and the hydrolysis vessel 110 It is set so that it does not pass through to the other side.
[0041]
The position and diameter of the through-hole 71b are such that the radiation from the solid phase extraction column 103 passes through the shielding plate 71 on the opposite side to the cartridge 15, while the radiation from the target water reservoir 101 and the hydrolysis vessel 110 15 is set so as not to pass through on the opposite side.
[0042]
Further, the opening position and the hole diameter of the through-hole 71c are such that the radiation from the hydrolysis vessel 110 passes through the shielding plate 71 on the opposite side to the cartridge 15, while the radiation from the target water reservoir 101 and the solid-phase extraction column 103 15 is set so as not to pass through on the opposite side.
[0043]
The reservoir radiation detector 73 detects the radiation radiated from the target water reservoir 101 through the through hole 71a, and the reaction vessel radiation detector 74 detects the radiation radiated from the solid phase extraction column 103 through the through hole 71b. The reaction vessel radiation detector 75 is attached to each of the shielding plates 71 so as to detect the radiation radiated from the hydrolysis vessel 110 through the through hole 71c.
[0044]
As such radiation detectors 73 to 75, for example, a semiconductor detector or a radiation detector having a radiation scintillator and a photomultiplier can be suitably used. Then, the radiation detectors 73 to 75 transmit information on the detected amount of radiation to the radioactivity acquisition unit 78a of the computer device 78, respectively.
[0045]
Returning to FIG. 1, the computer device 78 includes a radioactivity acquisition unit (apparatus radioactivity acquisition means) 78a for acquiring information on the amount of radiation from the radiation detectors 73 to 75 and acquiring the intensity of radioactivity. , A remaining time obtaining unit (remaining time obtaining means) 78b for obtaining the time required until the end of the FDG manufacturing process, and a standard yield storing unit in which the standard yield of FDG obtained by manufacturing in the main body unit 10 is stored in advance. (Yield storage means) 78d, based on the radioactivity intensity obtained by the radioactivity acquisition section 78a, the remaining time acquired by the remaining time acquisition section 78b, and the standard yield stored in the standard yield storage section 78d. It is configured to perform the same function as the radioactivity predicted value calculation unit (radioactivity predicted value acquisition unit) 78c that calculates the predicted value of the radioactivity intensity of the manufactured FDG at the end of the FDG manufacturing process. ing
[0046]
The radioactivity acquisition unit 78a, based on the information on the amount of radiation detected from the target water reservoir 101, the solid phase extraction column 103, and the hydrolysis vessel 110, the target water reservoir 101, the solid phase extraction column 103, Radiation intensity N in decomposition vessel 110 ₁ , N ₂ , N ₃ To get. For example, the intensity of radioactivity can be suitably acquired by dividing the count amount of radiation by a predetermined counting efficiency.
[0047]
Here, the reservoir radiation detector 73 and the radioactivity acquisition unit 78a constitute the radioactivity acquisition means 80 in the reservoir.
[0048]
The remaining time obtaining unit 78b starts a timer in response to a signal indicating that the manufacturing process has been started from the control unit 30, and sets a predetermined time T required for the manufacturing. _all From the elapsed time T of this timer _t Is the remaining time T _r Get as Here, the manufacturing start time t _s Before, the remaining time T _r Time required for manufacturing as T _all Is output.
[0049]
The standard yield storage unit 78d stores, as a standard yield, a standard value of the production yield of the FDG, which is empirically obtained in advance, in order to increase the prediction accuracy. Here, the standard yield is defined as (the radioactivity of the substance introduced into the reaction vessel / the radioactivity of the substance discharged from the reaction vessel after being subjected to the treatment, when the influence of spontaneous decay is excluded) Strength).
[0050]
Here, the standard yield ε in the target water reservoir 101 is stored in the standard yield storage unit 78d. ₁ , Standard yield ε in solid phase extraction column 103 ₂ , Standard yield ε in hydrolysis vessel 110 ₃ , Are respectively stored.
[0051]
The radioactivity predicted value calculation unit 78c calculates the remaining time T from the remaining time acquisition unit 78b. _r And the radioactivity intensity N in the target water reservoir 101 from the radioactivity acquisition unit 78a. ₁ Of the radioactivity N in the solid phase extraction column 103 ₂ And the intensity N of the radioactivity in the hydrolysis vessel 110 ₃ From the standard yield storage unit 78d. ₁ ~ Ε ₃ To get.
[0052]
And the remaining time T _r When the manufacturing process is not started, it is determined that the manufacturing process has not been started. When the manufacturing process is started at that time, the predicted value N of the radioactivity intensity N of the FDG obtained after the manufacturing is completed. _pred In the following equation (1): ₀ = N ₁ , T = T _all , Ε = ε ₁ Get as
(Equation 1)

Where T _0.5 Is ¹⁸ The half-life (s) of F.
[0053]
Note that the predicted value N _pred If the production is not started even after a predetermined time has passed since the acquisition, the predicted value of the intensity of the radioactivity is acquired again every predetermined time.
[0054]
In addition, the radioactivity predicted value calculation unit 78c indicates that the radioactivity intensity N in the solid phase extraction column 103 after the production process has started. ₂ Recorded the maximum value, the time t corresponding to this maximum value _2max Time remaining at _2max And, in the equation (1), T = T _2max , N ₀ = N ₂ , Ε = ε ₂ And the predicted value N of the radioactivity intensity N of the manufactured FDG _pred1 To get.
[0055]
After the maximum value is obtained, the predicted value of the intensity of the radioactivity is obtained again every elapse of a predetermined time.
[0056]
In addition, the radioactivity predicted value calculation unit 78c indicates that the production process has started and the radioactivity intensity N ₃ Recorded the maximum value, the time t corresponding to this maximum value _3max Time remaining at _3max And T = T in equation (1) _3max , N ₀ = N ₃ , Ε = ε ₃ And the predicted value N of the radioactivity intensity N of the manufactured FDG _pred2 To get.
[0057]
Further, the radioactivity predicted value calculation unit 78c calculates the radioactivity intensity N in the hydrolysis vessel 110. ₃ After recording the maximum value, T = T in equation (1) every predetermined time. _r , N ₀ = N ₃ , Ε = ε ₃ And the predicted value N of the radioactivity intensity N of the manufactured FDG _pred3 To get.
[0058]
The display 76 appropriately displays the predicted value N of the intensity of the radioactivity predicted by the radioactivity predicted value calculation unit 78c.
[0059]
Next, the operation of the labeled compound manufacturing apparatus 100 according to the present embodiment will be described with reference to FIGS.
[0060]
First, the containers 106 and 132 containing the reagent are set in the cartridge 15.
[0061]
Next, the operator sets the cartridge in the main body 10.
[0062]
Subsequently, the operator was generated in a cyclotron etc. ¹⁸ A predetermined amount of target water containing F ions is stored in the target water reservoir 101 of the cartridge 15. This completes the pre-processing for manufacturing.
[0063]
Here, the radioactivity prediction device 70 detects the amount of radiation from the target water reservoir 101 and determines the intensity of radioactivity N in the target water reservoir 101. ₁ To obtain a standard yield ε ₁ And the time T required to start the manufacturing process from now _all And the predicted value N of the intensity of the radioactivity of the FDG obtained at the end of the manufacturing process based on the equation (1). _pred1 Is displayed on the display 76.
[0064]
Where is a radioisotope ¹⁸ F has a short half-life of 110 minutes, and immediately after the target water is introduced into the target water reservoir 101, the intensity N of the radioactivity in the target water reservoir 101 ₁ Decays. This is shown in FIG.
[0065]
Then, the radioactivity prediction device 70 detects radiation from the target water reservoir 101 at predetermined time intervals, and detects the radioactivity N ₁ And if the manufacturing operation is started at that time, the predicted value N of the radioactivity intensity of FDG obtained after the end of the manufacturing is obtained. _pred1 Get and display.
[0066]
Next, when the operator presses the production start button on the console 40, the production process is started. This time corresponds to t in FIG. _s It is. This manufacturing process is automatically controlled by the control unit 30. The manufacturing process in the labeled compound manufacturing apparatus 100 mainly includes a process of manufacturing an FDG precursor, and a subsequent process of hydrolyzing the FDG precursor.
[0067]
First, the target water reservoir 101 is moved to the syringe 102 by driving the syringe driving mechanism S3. ¹⁸ A predetermined amount of target water containing F ions is sucked. Thereby, as shown in FIG. 4, the intensity N of radioactivity from inside the target water reservoir 101 ₁ Decreases.
[0068]
Next, the target water in the syringe 102 is gradually supplied to the solid-phase extraction column 103 by driving the syringe driving mechanism S3. In the solid phase extraction column 103, the target water ¹⁸ While F ions are fixed to the solid-phase extraction column 103 by an ion exchange reaction, ¹⁸ The remaining component mainly composed of O passes through the solid-phase extraction column 103 and is collected in a drain (not shown).
[0069]
At this time, the solid-phase extraction column 103 ¹⁸ Since the F ions are immobilized, as shown in FIG. ₂ At a certain time t _2max Get the maximum value N _2max After that, it gradually decreases with radioactive decay.
[0070]
Here, the radioactivity prediction device 70 determines that the amount of radioactivity from the solid phase extraction column 103 is the maximum value N _2max Is recorded, the radioactivity intensity N of the solid phase extraction column 103 is recorded. ₂ And standard yield ε ₂ And the predicted value N of the intensity of the radioactivity of the FDG at the end of the manufacturing process _pred2 Get and display.
[0071]
Next, the triflate in the container 106 is introduced into the solid-phase extraction column 103 by driving the syringe driving mechanism S1. Thereby, an FDG precursor (acetylated FDG) is generated, and the generated FDG precursor flows into the hydrolysis vessel 110.
[0072]
In this operation, as shown in FIG. 4, since the FDG precursor flows into the hydrolysis vessel 110, the intensity of the radioactivity in the hydrolysis vessel 110 increases, and at a certain time t _3max And the maximum value N _3max After that, the intensity of radioactivity gradually decreases with radioactive decay.
[0073]
Then, the radioactivity prediction device 70 determines that the radioactivity amount from the hydrolysis vessel 110 is the maximum value N _3max Is recorded, the radioactivity intensity N of the hydrolysis vessel 110 is recorded. ₃ And standard yield ε ₃ Is the predicted value N of the radioactivity intensity of the FDG after the end of the manufacturing process. _pred3 To get.
[0074]
Here, rinsing is performed with pure water or the like so that the FDG precursor remains as little as possible in the solid phase extraction column 103, and the FDG precursor in the solid phase extraction column 103 is efficiently introduced into the hydrolysis vessel 110. .
[0075]
Then, the reaction liquid for hydrolysis in the container 132 is introduced into the hydrolysis container 110 by driving the syringe driving mechanism S4. This hydrolyzes the FDG precursor to produce FDG.
[0076]
In this operation, as shown in FIG. ₃ Decay mainly due to spontaneous radioactive decay. Here, the predicted value N _pred3 Is obtained at predetermined time intervals, but its value hardly changes unless there is a problem.
[0077]
Next, in FIG. 2, the mixture containing FDG in the hydrolysis container 110 is sucked into the syringe 120 by driving the syringe driving mechanism S6. Thereafter, by driving the syringe driving mechanism S6, the mixture containing FDG in the syringe 120 is sequentially passed through the first purification column 140 and the second purification column 150 to purify the FDG. Then, the purified FDG is introduced into the product container 20, and a series of manufacturing steps is completed.
[0078]
And the standard yield ε ₁ ~ Ε ₃ Is appropriately set, and if there is no defect in each process, the intensity N of the radioactivity of the FDG in the product container 20 after the end of the manufacturing process is N of the predicted value predicted in each process. _pred1 , N _pred2 , N _pred3 Is almost the same as
[0079]
Next, in the manufacturing process, ¹⁸ The operation in the case where a problem that the yield of F deteriorates will be described.
[0080]
For example, immobilized on the solid phase extraction column 103 ¹⁸ When F is not sufficiently transferred into the hydrolysis vessel 110, as shown in FIG. ₃ Value, for example, t _3max N at time _3max Etc. are lower than normal. Therefore, t _3max The predicted value N of the radioactivity intensity of the manufactured FDG obtained thereafter _pred3 Is t _3max Predicted value N obtained before _Pred1 And N _pred2 Lower than. And this lowered N _pred3 Corresponds to the intensity of the radioactivity in the hydrolysis vessel 110 reduced by the defect, and is substantially the same as the intensity N of the radioactivity of the FDG obtained after the end of the manufacturing process. Therefore, the operator can use the radioactivity prediction device 70 to predict that the intensity N of the radioactivity of the FDG obtained after the production in the middle of the production process is lower than expected, and how much the radioactivity N will be reduced.
[0081]
Further, for example, as shown in FIG. _3max Time t after ₁₀ In the case where a failure occurs, for example, the intensity of radioactivity N in the hydrolysis vessel 110 ₃ Is the time t ₁₀ To N lower than normal _3down It becomes. Then, the intensity N of the radioactivity of the FDG obtained after the end of the production also becomes lower than that in the normal case, as shown in the figure.
[0082]
In this case as well, the radioactivity prediction device 70 causes the lowered N _3down Of the radioactivity intensity of FDG after the end of the manufacturing process is lower than the normal case based on _pred3b Is acquired and displayed. Therefore, the operator can obtain a predicted value of the intensity of the radioactivity of the FDG obtained after the end of the manufacturing process before the end of the manufacturing process.
[0083]
As described above, in the present embodiment, the amount of radiation radiated from the solid phase extraction column 103 and the hydrolysis vessel 110 during the manufacturing process (predetermined process) is acquired, and the manufacturing process is performed based on the acquired radiation amount. The predicted value of the radioactivity intensity of the FDG obtained after completion is obtained during the manufacturing process. Therefore, during the manufacturing process, the solid phase extraction column 103 or the hydrolysis vessel 110 ¹⁸ Even when a problem such as F scatters out of the system occurs, a predicted value of the intensity of radioactivity of the finally manufactured FDG can be grasped during the manufacturing process according to the problem. Therefore, when such a problem occurs, preparation for changing the clinical schedule, remanufacturing the labeled compound, and the like can be quickly performed.
[0084]
In addition, since the radioactivity acquisition unit 78a acquires information on the intensity of radioactivity in the reaction device based on the information on the amount of radiation, the radioactivity prediction value acquisition means performs the radioactivity estimation in the predetermined device Thus, the predicted value of the radioactivity intensity of the labeled compound produced by the predetermined treatment can be preferably predicted based on the information on the radioactivity.
[0085]
In addition, since the remaining time required from the time when the amount of radiation is acquired to the end of the manufacturing process is acquired, the radioactivity is reduced by natural decay from the time when the amount of radiation is acquired to the end of the manufacturing process. Taking into account the amount of attenuation, the intensity of radioactivity of FDG manufactured with high accuracy is predicted.
[0086]
Further, a standard yield storage unit 78d in which the production yield of FDG in each reaction vessel is stored in advance is provided. Based on the production efficiency in each reaction vessel, the prediction of the intensity of the radioactivity of FDG is performed. The value can be obtained with higher accuracy.
[0087]
In addition, since the amount of radiation from the inside of the solid phase extraction column 103 or the hydrolysis vessel 110, which requires a relatively long time treatment and is likely to cause problems such as scattering of radioisotopes, is measured, What happened can be detected immediately and a decrease in the predicted value of FDG activity can be obtained quickly.
[0088]
In addition, the amount of radiation from inside the target water reservoir 101 is obtained, and the predicted value of the radioactivity of the FDG after manufacturing can be obtained before starting the manufacturing process.
[0089]
In addition, since the radiation detectors 73 to 75 detect the radiation through the through holes 71a to 71c of the shielding plate 71 whose orientation and size are suitably set, noise from a radiation source such as another instrument is removed. The amount of radiation from the target instrument can be acquired accurately with a sufficient reduction.
[0090]
(Second embodiment)
Next, a second embodiment of the present invention will be described.
[0091]
FIG. 7 is an apparatus 200 for producing a labeled compound according to the second embodiment. The labeled compound producing apparatus 200 of the present embodiment includes: ¹⁸ An FDG as a labeling compound is produced by a process different from that of the first embodiment, using an aqueous solution containing F ions, triflate, or the like as a raw material. The major points of the labeled compound manufacturing apparatus 200 different from the labeled compound manufacturing apparatus 100 according to the first embodiment are that a fixed piping system is used without using a cartridge that is replaced every single manufacturing operation, The predicted value N of the radioactivity intensity of the FDG that is manufactured while controlling the system valves and the like. _pred Is provided with the general control device 178 that acquires
[0092]
Hereinafter, the labeling compound manufacturing apparatus 200 will be described in detail. The labeled compound manufacturing apparatus 200 is formed while controlling and controlling the main body 212, the FDG produced in the main body 212, the product container 20, and the main body 212 that perform various reactions and the like required for the production. Predicted value N of radioactivity intensity of FDG _pred 178, a console 40 to which an instruction from an operator is input and an instruction from the general control device 178 is output, a printer 50 to which data from the general control device 178 are output, A display 76 for displaying data from the device 178 to the operator.
[0093]
The main body 212 mainly includes ¹⁸ A target water reservoir 201 in which target water containing F ions is introduced in advance, and target water from the target water reservoir 201 supplied to the target water reservoir 201 ¹⁸ A solid phase extraction column (reaction vessel) 203 for immobilizing F ions, ¹⁸ The FDG is reacted with triflate to generate an FDG precursor, and the generated FDG precursor is hydrolyzed by a hydrolysis reaction solution that causes hydrolysis to obtain FDG as a target labeled compound. A decomposition vessel (reaction vessel) 210 and a purification column 275 for purifying the FDG produced in the hydrolysis vessel 210 are provided.
[0094]
Further, a container 221 for storing the reaction catalyst and a container 223 for storing the free liquid are connected to the upstream side of the solid-phase extraction column 203, respectively.
Further, a container 225 for receiving the drainage of the target water is connected to the downstream side of the solid-phase extraction column 203.
[0095]
The hydrolysis container 210 is a vertically long container.
Further, a purification column 275 is connected downstream of the hydrolysis vessel 210, and a product container 20 is connected downstream of the purification column 275.
[0096]
The purification column 275 is a C18 column for solid-phase extraction, a neutral alumina column, or the like, and removes coloring substances, unhydrolyzed products, and the like from FDG.
[0097]
The hydrolysis container 210 contains a container 227 for storing triflate, a container 231 for storing a hydrolysis reaction solution that causes a hydrolysis reaction, and water for rinsing the hydrolysis container 210 and the purification column 275. The container 233 to be stored is connected.
[0098]
Further, the main body 212 has a heater H3, and can heat the hydrolysis container 210.
[0099]
Further, the main body 212 includes a reservoir radiation detector 73 that detects radiation from the target water reservoir 101, a reaction vessel radiation detector 74 that detects radiation from the solid phase extraction column 203, and a And a reaction vessel radiation detector 75 for detecting radiation. The configurations of these radiation detectors 73 to 75 are the same as in the first embodiment.
[0100]
The general control device 178 includes a control unit 130, a radioactivity acquisition unit 78a, a remaining time acquisition unit 78b, a radioactivity prediction value calculation unit 78c, and a standard yield storage unit 78d.
[0101]
The control unit 130 controls the main unit 212 in a predetermined order and timing when a signal to start manufacturing is input from the console switch 40 by an operation of the operator.
[0102]
The functions and configurations of the radioactivity acquisition unit 78a, the remaining time acquisition unit 78b, the standard yield storage unit 78d, the radioactivity prediction value calculation unit 78c, and the radioactivity prediction value calculation unit 78c are the same as those in the first embodiment. It is.
[0103]
In the present embodiment, the reservoir radiation detector 73, the reaction vessel radiation detectors 74 and 75, the radioactivity acquisition unit 78a, the remaining time acquisition unit 78b, the standard yield storage unit 78d, and the radioactivity prediction value calculation unit 78c emit radiation. The function prediction device 270 is constituted. Further, the reservoir radiation detector 73 and the radioactivity acquisition unit 78a constitute a radioactivity acquisition means 80 in the reservoir.
[0104]
The display 76 displays the predicted value N of the intensity of the radioactivity predicted by the radioactivity predicted value calculation unit 78c. _pred In addition, the status of the main body 212 controlled by the control unit 130 is appropriately displayed.
[0105]
Next, the operation of the labeled compound manufacturing apparatus 200 according to the present embodiment will be described.
[0106]
First, a free liquid was obtained in the container 223, and a cyclotron or the like was obtained in the target water reservoir 201. ¹⁸ Target water containing F ions, a reaction catalyst in the container 221, triflate in the container 227, water in the container 233, and a hydrolysis reaction liquid in the container 231 are previously introduced.
[0107]
Next, when the operator presses the production start button on the console 40, the FDG production process is started.
[0108]
The manufacturing process in the labeled compound manufacturing apparatus 200 is mainly performed from target water. ¹⁸ Extracting F ions, and extracting the extracted ions. ¹⁸ Generating and hydrolyzing an FDG precursor containing F ions, and the steps including these steps are automatically performed by the control unit 130 of the integrated control device 178.
[0109]
First, the target water in the target water reservoir 201 is supplied to the solid phase extraction column 203. In the solid phase extraction column 203, the target water ¹⁸ While F ions are fixed to the solid-phase extraction column 203 by an ion exchange reaction, ¹⁸ The remaining component mainly composed of O passes through the solid-phase extraction column 203 and is collected in the container 225. In addition, it was collected in the container 225 in this way. ¹⁸ The water containing O is again in the cyclotron ¹⁸ Reused for production of F ions.
[0110]
Next, the free liquid of the container 223 was supplied into the solid-phase extraction column 203, and was fixed to the solid-phase extraction column 203. ¹⁸ F ions are eluted. And eluted ¹⁸ An aqueous calcium carbonate solution containing F ions is introduced into the hydrolysis vessel 210. Subsequently, the reaction catalyst in the container 221 is introduced into the hydrolysis container 210 via the solid-phase extraction column 203.
[0111]
Next, the water and the organic solvent in the hydrolysis vessel 210 are removed by evaporation.
Thereafter, the triflate in the container 227 is introduced into the hydrolysis container 210, and a fluorination reaction of the triflate is performed to generate an FDG precursor (acetylated FDG).
[0112]
Then, after the inside of the hydrolysis vessel 210 is heated to remove the solvent, a reaction liquid for hydrolysis is charged from the inside of the vessel 231 to hydrolyze the FDG precursor in the hydrolysis vessel 210.
[0113]
Thereafter, the FDG in the hydrolysis vessel 210 is introduced into the purification column 275 for purification, and the purified FDG is charged into the product container 20.
[0114]
Finally, rinsing is performed by supplying distilled water from the container 233 to the hydrolysis container 210 and the purification column 275, and the rinsing liquid is introduced into the product container 20 to complete the manufacturing process.
[0115]
In this series of manufacturing steps, in the same manner as in the first embodiment, the intensity of the radioactivity in the target water reservoir 201, the solid-phase extraction column 203, and the hydrolysis vessel 210 is obtained, and based on the above-described equation (1). Of FDG radioactivity after the end of manufacturing process _pred1 , N _pred2 , N _pred3 , Are displayed on the display 76. Thereby, the same operation and effect as those of the first embodiment can be obtained.
[0116]
Here, as an example, ¹⁸ After the F ions are introduced into the hydrolysis vessel 210, the predicted value N based on the radiation emitted from the hydrolysis vessel 210 _pred Will be described.
[0117]
FIG. 8 shows the radioactivity intensity N in the hydrolysis vessel 210. ₃ 5 is a graph showing a change in the graph.
[0118]
Time t ₂₀₁ Eluted by calcium carbonate at time ₁₈ When F ions flow in from the solid-phase extraction column 203, the intensity of radioactivity increases, and t _3max And the intensity of radioactivity is the maximum value N _3max become. Then, at this time, the predicted value N of the intensity of radioactivity of the manufactured FDG _pred3 Is acquired and displayed. ¹⁸ It is possible to determine whether or not there is a problem in the elution of F ions, and the predicted value N when there is a problem _pred Is also grasped immediately.
[0119]
In addition, at every predetermined time, the predicted value of radioactivity N _pred3 Are repeatedly obtained, so for example, t ₂₀₂ While heating the hydrolysis vessel in the vicinity, ¹⁸ When there is a problem such as that F is discharged out of the system as a gas, it is immediately understood that the radioactivity decreases after the completion of the FDG manufacturing process.
[0120]
Similarly, the hydrolysis is completed, and t is immediately before the FDG is discharged from the hydrolysis vessel 210. ₂₀₃ Also the predicted value of radioactivity N _pred3 Is obtained, and the intensity of the radioactivity of the produced FDG is accurately predicted.
[0121]
The present invention is not limited to the above embodiment, and can take various modifications.
[0122]
For example, in the above embodiment, the labeling compound is used for PET (Position Emission Tomography) measurement. ¹⁸ Although FDG containing F is produced, other labeled compounds may be produced.
[0123]
For example, ¹⁸ As a labeling compound containing F, FPAMT ( ¹⁸ F-labeled-propyl afafamethyltyrosine). Further, as a labeled compound for PET measurement containing other radioisotopes, ¹¹ Acetic acid containing C, ^Thirteen Ammonia containing N, ^Fifteen O-containing water and the like.
[0124]
Further, a labeled compound for SPECT (Single Photon Emission Tomography) measurement may be used. ⁶⁷ Ga, ²⁰¹ Tl, ¹²³ Labeled compounds containing I.
[0125]
In the above-described embodiment, the remaining time obtaining unit 78b is provided, and the predicted value of the intensity of the radioactivity of the FDG at the end of the manufacturing process is obtained based on the remaining time obtaining unit 78b, but is not limited thereto. For example, as shown in FIGS. 1 and 7, a standard trend storage unit (reference data storage unit) in which reference data on information on the intensity of radioactivity in a reaction vessel in the course of performing a manufacturing process is stored in advance. 90, the radioactivity predicted value calculation unit 78c compares the radioactivity intensity acquired by the radioactivity acquisition unit 78a with the radioactivity intensity reference data stored in the standard trend storage unit 90. Based on this, a predicted value of the radioactivity intensity of the manufactured FDG may be obtained. For example, the predicted value of the intensity of the radioactivity may be reduced in accordance with the deviation from the reference data.
[0126]
In the above embodiment, the amount of radiation radiated from the solid phase extraction column 103 or the hydrolysis vessel 110, which is a reaction vessel, is measured. However, a labeled compound such as a line through which a substance containing a radioisotope passes is used. The amount of radiation emitted from another device (corresponding to a predetermined device) on which a predetermined process is performed during the manufacturing process may be measured. For example, in the first embodiment, the line between the target water reservoir 101 and the solid phase extraction column 103, the syringe 102, the line between the solid phase extraction column 103 and the hydrolysis vessel 110, the solid phase extraction column 103 The amount of radiation emitted from the line between the purification column 140 and the inside of the purification columns 140 and 150 can be measured.
[0127]
In the above embodiment, the computer automatically predicts the intensity of the radioactivity. However, the prediction of the intensity of the radioactivity is automatically performed by the apparatus, and the acquisition of the predicted value is performed by an operator or the like. You may go.
[0128]
【The invention's effect】
According to the present invention, information on the amount of radiation emitted from within the predetermined instrument is acquired during the predetermined processing, and the intensity of the radioactivity of the labeled compound obtained after completion of the predetermined processing based on the information is obtained. Is obtained in the middle of a predetermined process. For this reason, even if a problem such as the radioisotope being scattered from the inside of the instrument to the outside of the system during the predetermined treatment occurs, the predicted value of the radioactivity intensity of the finally obtained labeled compound is not It can be grasped during a predetermined process according to a defect. Therefore, when such a problem occurs, preparation for changing the clinical schedule, remanufacturing the labeled compound, and the like can be quickly performed.
[Brief description of the drawings]
FIG. 1 is a schematic diagram showing an apparatus for producing a labeled compound according to a first embodiment.
FIG. 2 is a partially cutaway front view of a main body in FIG.
FIG. 3 is a schematic sectional view taken along line III-III in FIG. 1;
FIG. 4 is a first graph showing a time-dependent change in the intensity of radioactivity in a reservoir tank, a solid-phase extraction column, and a hydrolysis vessel obtained by the radioactivity acquisition unit in FIG. 1 during the process of FDG production. .
FIG. 5 is a second graph showing a time-dependent change in the intensity of the radioactivity in the reservoir tank, the solid-phase extraction column, and the hydrolysis vessel obtained by the radioactivity acquisition unit in FIG. 1 during the process of FDG production. .
6 is a third graph showing a temporal change in the intensity of the radioactivity in the reservoir tank, the solid-phase extraction column, and the hydrolysis vessel, respectively, acquired by the radioactivity acquisition unit in FIG. 1 during the process of FDG production. .
FIG. 7 is a schematic diagram showing an apparatus for producing a labeled compound according to a second embodiment.
8 is a graph showing the change over time in the intensity of radioactivity in the hydrolysis container obtained by the radioactivity acquisition unit in FIG. 7 during the process of producing FDG.
[Explanation of symbols]
100, 200: Labeled compound producing device, 70, 270: Radioactivity predicting device, 71: Shielding plate (shielding member), 74, 75: Reaction vessel radiation detector (instrument radiation detecting means), 78a: Radioactivity acquisition unit ( Instrument radioactivity acquisition means), 78b ... remaining time acquisition section (remaining time acquisition means), 78c ... radioactivity prediction value calculation section (radiation prediction value acquisition means), 78d ... standard yield storage section (yield storage means) Reference numeral: 80: means for acquiring radioactivity in the reservoir; 90: standard trend storage unit (reference data storage means); 101: reservoir tank (reservoir); 103, 203: solid phase extraction column (reaction vessel); 110, 210: hydrolysis Vessel (reaction vessel).

Claims (11)

When producing a labeled compound containing a radioisotope by performing a predetermined treatment in a predetermined instrument, a radioactivity for obtaining a predicted value of the radioactivity intensity of the labeled compound obtained after the completion of the predetermined treatment A prediction device,
Instrument radiation detecting means for acquiring information on the amount of radiation emitted from within the predetermined instrument during the predetermined processing,
Based on the information on the amount of radiation radiated from within the predetermined instrument obtained by the instrument radiation detecting means, obtain a predicted value of the radioactivity intensity of the labeled compound obtained after the completion of the predetermined processing. A radioactivity prediction device, comprising: a radioactivity prediction value acquisition unit. An appliance radioactivity acquisition unit that acquires information about the intensity of radioactivity in the predetermined appliance based on information about the amount of radiation acquired by the appliance radiation detection unit, the radioactivity prediction value acquisition unit includes: The radioactivity prediction apparatus according to claim 1, wherein a predicted value of the radioactivity of the labeled compound is predicted based on information on the radioactivity in the predetermined device. The apparatus further includes a remaining time obtaining unit configured to obtain a remaining time from a time at which information on the amount of the radiation is obtained by the instrument radiation detecting unit to a time at which the predetermined process is scheduled to be completed,
The radioactivity prediction device according to claim 1, wherein the radioactivity prediction value obtaining unit further obtains a radioactivity prediction value of the labeled compound based on the remaining time. . Reference data storage means in which reference data for information on the amount of radiation radiated from within the device in the process in which the predetermined process is performed is stored in advance,
The radioactivity predicted value obtaining means, based on a comparison between information about the amount of radiation acquired by the instrument radiation detecting means and reference data of information about the amount of radiation stored in the reference data storage unit, The radioactivity prediction device according to claim 1, wherein a predicted value of the radioactivity intensity of the labeled compound is obtained. The apparatus further comprises a yield storage unit in which the production yield of the labeled compound in the device is stored in advance, and the radioactivity predicted value obtaining unit further includes a radioactive predicted value acquisition unit based on the production yield in the device. The radioactivity prediction apparatus according to any one of claims 1 to 4, wherein a predicted value of the radioactivity intensity is obtained. The predetermined device includes a reaction container in which a chemical reaction is performed,
The radioactivity predicting device according to any one of claims 1 to 5, wherein the instrument radiation detecting unit acquires information on an amount of radiation emitted from the inside of the reaction vessel. The reaction vessel is supplied with an aqueous solution containing the radioisotope, an extraction column for extracting the radioisotope from the aqueous solution by an ion exchange reaction, and an acid or a precursor containing the radioisotope extracted by the extraction column. A hydrolysis vessel that hydrolyzes with an alkali to produce the labeled compound,
The said instrument radiation detection means acquires the information regarding the quantity of the radiation radiated from the said extraction column, and the information regarding the quantity of the radiation radiated from within the hydrolysis container, respectively, The Claims characterized by the above-mentioned. 7. The radioactivity prediction device according to 6. The apparatus according to claim 1, further comprising a reservoir radiation detecting unit configured to acquire information on an amount of radiation radiated from a reservoir in which the raw material containing the radioactive substance to be introduced into the predetermined device is stored. The radioactivity prediction apparatus according to any one of claims 1 to 4. A shielding member formed of lead and facing the predetermined instrument, and having a through-hole facing the predetermined instrument, wherein the instrument radiation detecting means is provided through the through-hole of the shielding member; The radioactivity prediction device according to claim 1, wherein radiation emitted from inside is detected. The radioactivity prediction device according to any one of claims 1 to 9,
An apparatus for performing the predetermined treatment therein. An apparatus for producing a labeled compound, comprising: When producing a labeled compound containing a radioisotope by performing a predetermined treatment in a predetermined instrument, a radioactivity for obtaining a predicted value of the radioactivity intensity of the labeled compound obtained after the completion of the predetermined treatment A prediction method,
An instrument radiation detection step of obtaining information regarding the amount of radiation emitted from within the predetermined instrument during the predetermined process;
Based on the information on the amount of radiation emitted from within the predetermined instrument obtained by the instrument radiation detection step, obtain a predicted value of the radioactivity intensity of the labeled compound obtained after the completion of the predetermined processing. A radioactivity prediction value obtaining step.

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