JP2022063016A

JP2022063016A - Shielding container for radiopharmaceuticals

Info

Publication number: JP2022063016A
Application number: JP2020171291A
Authority: JP
Inventors: 真一野口; Shinichi Noguchi; 悠矢藤井; Yuya Fujii
Original assignee: Fujifilm Toyama Chemical Co Ltd
Current assignee: Fujifilm Toyama Chemical Co Ltd
Priority date: 2020-10-09
Filing date: 2020-10-09
Publication date: 2022-04-21
Anticipated expiration: 2040-10-09
Also published as: JP7165706B2; JP7520399B2; JP2023002704A

Abstract

PROBLEM TO BE SOLVED: To provide a shielding container for radiopharmaceuticals provided with a lid in which there is no risk of the radiation shielding material falling from the lid and the radiation shielding material for reuse can be separated and taken out extremely easily.
SOLUTION: A radiation shielding lid in which a radiation shielding material is housed in a bottomed tubular body and an opening of the bottomed tubular body is detachably closed by a closing member is a bottomed tubular body. A shielding container for radiopharmaceuticals, characterized in that it is detachably attached to the main body of the radiation shielding container on the bottom side.
[Selection diagram] Fig. 1

Description

本発明は、放射性医薬品の輸送や保管の際に、放射性医薬品から放出される放射線による人体への被曝を防止するために用いられる放射性医薬品用遮蔽容器に関する。 The present invention relates to a shield container for radiopharmaceutical drugs used to prevent exposure to the human body by radiation emitted from the radiopharmaceutical drug during transportation and storage of the radiopharmaceutical drug.

放射性医薬品としては、一般にバイアル入り注射液や薬液充填済みシリンジが汎用されており、これらは放射線による人体への被曝防止のため放射線遮蔽容器に収納して輸送や保管されている。
斯かる放射線遮蔽容器としては、放射線遮蔽材を備えた容器本体と、放射線遮蔽材を備えた蓋体から構成されたものが既に知られている（例えば特許文献１参照）。 As radiopharmaceuticals, injection solutions in vials and syringes filled with chemical solutions are generally used, and these are stored in a radiation shielding container to prevent exposure to the human body due to radiation, and are transported or stored.
As such a radiation shielding container, a container main body provided with a radiation shielding material and a lid body provided with the radiation shielding material are already known (see, for example, Patent Document 1).

然るとき、斯かる従来の放射線遮蔽容器は、高価な放射線遮蔽材を蓋体の下方から分別取り出してリユースするために、放射線遮蔽材を蓋体の内部に吊り下げた状態で保持していた。そのため重量物である放射線遮蔽材が放射性医薬品の使用中に蓋体から外れて落下し、作業者のケガにつながる恐れがあった。他方、その落下を防止すべく放射線遮蔽材の吊り下げ状態を強固なものとすると、リユースのための分別取り出しが困難になると云う問題があった。 At that time, such a conventional radiation shielding container holds the radiation shielding material suspended inside the lid in order to separately take out the expensive radiation shielding material from below the lid and reuse it. .. Therefore, there is a risk that the radiation shielding material, which is a heavy object, may come off the lid and fall off during the use of the radiopharmaceutical, resulting in injury to the worker. On the other hand, if the hanging state of the radiation shielding material is strengthened in order to prevent the radiation from falling, there is a problem that it becomes difficult to separate and take out the radiation shielding material for reuse.

特開２００５－３１５５７７号公報Japanese Unexamined Patent Publication No. 2005-315777

本発明は、上記の如き従来の問題に鑑みてなされたものであり、放射線遮蔽材が蓋体から落下する恐れがなく、しかもリユースのための放射線遮蔽材の分別取り出しを極めて容易に行なうことができる蓋体を備えた放射性医薬品用遮蔽容器を提供することを課題としている。 The present invention has been made in view of the above-mentioned conventional problems, and there is no risk that the radiation shielding material will fall from the lid, and the radiation shielding material for reuse can be separated and taken out extremely easily. The challenge is to provide a shielding container for radiopharmaceuticals equipped with a capable lid.

本発明者は、上記の課題を解決すべく鋭意研究を重ねた結果、放射線遮蔽材を蓋体内部に吊り下げず、有底筒状体に収納して蓋体とすれば、極めて良い結果が得られることを見い出し、本発明を完成した。 As a result of diligent research to solve the above problems, the present inventor has obtained extremely good results if the radiation shielding material is not suspended inside the lid but is stored in a bottomed tubular body to form a lid. The present invention was completed by finding out what can be obtained.

すなわち、本発明は、有底筒状体に放射線遮蔽材が収納され、かつ当該有底筒状体の開口部が閉止部材で着脱自在に閉止された放射線遮蔽蓋体が、当該有底筒状体の底部側において放射線遮蔽容器本体に着脱自在に取り付けられていることを特徴とする放射性医薬品用遮蔽容器により解決したものである。 That is, in the present invention, the radiation shielding lid body in which the radiation shielding material is housed in the bottomed tubular body and the opening of the bottomed tubular body is detachably closed by the closing member is the bottomed tubular body. This is solved by a shielding container for radiopharmaceuticals, which is characterized by being detachably attached to the main body of the radiation shielding container on the bottom side of the body.

本発明の放射性医薬品用遮蔽容器によれば、蓋体の放射線遮蔽材が有底筒状体に収納されているので、それが、放射性医薬品の使用中に落下する恐れは全くない。しかも、上部の蓋部材を取り外すだけで有底筒状体の上部開口部から放射線遮蔽材のみを極めて容易に取り出すことができる。 According to the radiopharmaceutical shielding container of the present invention, since the radiation shielding material of the lid is housed in the bottomed tubular body, there is no possibility that it will fall during the use of the radiopharmaceutical. Moreover, only the radiation shielding material can be taken out very easily from the upper opening of the bottomed cylindrical body only by removing the upper lid member.

本発明放射性医薬品用遮蔽容器の縦断面説明図。The vertical sectional view explanatory view of the shielding container for radiopharmaceuticals of this invention. 本発明で用いる閉止部材例を示す縦断面説明図。An explanatory vertical cross-sectional view showing an example of a closing member used in the present invention. 本発明で用いる閉止部材例を示す平面説明図。The plan view which shows the example of the closing member used in this invention. 本発明の放射線遮蔽容器本体の底面説明図。The bottom explanatory view of the radiation shielding container main body of this invention.

以下、本発明の実施の形態を図面と共に説明する。 Hereinafter, embodiments of the present invention will be described with reference to the drawings.

図１において、１０は放射線遮蔽蓋体で、上部に開口部１１ａを有すると共に、下部が底部１１ｂで閉塞された有底筒状体１１の内部に略円盤状の放射線遮蔽材１２が収納されている。 In FIG. 1, reference numeral 10 denotes a radiation shielding lid, in which a substantially disk-shaped radiation shielding material 12 is housed inside a bottomed tubular body 11 having an opening 11a at the top and a bottom closed at the bottom 11b. There is.

ここに収納は、有底筒状体１１への放射線遮蔽材１２の単なる挿置であっても良いが、当該放射線遮蔽材１２の下部に形成した突出部を有底筒状体１１の底部１１ｂに形成した凹所に挿入嵌合して収納するのが、当該放射線遮蔽材１２の有底筒状体１１内における横方向の動きを抑止し、安定に保持固定する上で望ましい。より具体的には、図１に示したように、放射線遮蔽材１２の下面外縁部に、内側から外側方向に下降傾斜するテーパー内面１２ｂを有する筒状突出部１２ａを形成すると共に、有底筒状体１１の底部１１ｂ外縁部に当該筒状突出部１２ａの外形に対応するテーパー付きの環状凹所１１ｃを形成して、当該環状凹所１１ｃに筒状突出部１２ａを挿入嵌合するのが、放射線遮蔽材１２の動き抑止はもとより、嵌合操作性とその離脱操作性にも優れ、特に有利である。尚、当該筒状突出部１２ａの内面の下降傾斜角度としては、放射線遮蔽材１２の下面を基準に９５°～１７５°であればよいが、１００°～１３５°が好ましく、１００°～１１５°が特に好ましい。 The storage here may be a simple insertion of the radiation shielding material 12 into the bottomed tubular body 11, but the protruding portion formed at the lower part of the radiation shielding material 12 is formed at the bottom portion 11b of the bottomed tubular body 11. It is desirable to insert and fit the radiation shielding material 12 into the recess formed in the above to prevent lateral movement of the radiation shielding material 12 in the bottomed tubular body 11 and to stably hold and fix the radiation shielding material 12. More specifically, as shown in FIG. 1, a tubular protrusion 12a having a tapered inner surface 12b that inclines downward from the inside to the outside is formed on the outer edge of the lower surface of the radiation shielding material 12, and a bottomed cylinder is formed. An annular recess 11c having a taper corresponding to the outer shape of the tubular protrusion 12a is formed on the outer edge of the bottom portion 11b of the shape 11, and the tubular protrusion 12a is inserted and fitted into the annular recess 11c. In addition to suppressing the movement of the radiation shielding material 12, it is also excellent in fitting operability and detachment operability, which is particularly advantageous. The downward inclination angle of the inner surface of the tubular protrusion 12a may be 95 ° to 175 ° with respect to the lower surface of the radiation shielding material 12, but is preferably 100 ° to 135 °, and is preferably 100 ° to 115 °. Is particularly preferable.

また、当該放射線遮蔽材１２は、有底筒状体１１の底部１１ｂとの間に空域部１３を設けて収納するのが、後述する放射線遮蔽容器本体２０に収納されるバイアル３０等の医薬品が当該底部１１ｂに当った際に、その衝撃を軽減する上で望ましい。この場合、空域部１３の大きさとしては、上下の間隔が３．０～１０．０ｍｍで、バイアル蓋３０ａ等の収納する医薬品の上部径よりも大きな径とするのが好ましい。また、当該空域部１３の形成手段は、スペーサーの介在等特に限定されないが、放射線遮蔽材１２の下面部に適宜凹所を設けて形成するのが簡便である。
尚、有底筒状体１１の材質としては、ポリプロピレンやポリエチレン等のプラスチックが好ましいものとして挙げられ、放射線遮蔽材１２の材質としては、鉛、タングステンが好ましいものとして挙げられる。 Further, the radiation shielding material 12 is stored by providing an airspace portion 13 between the bottom portion 11b of the bottomed tubular body 11 and a medicine such as a vial 30 stored in the radiation shielding container main body 20, which will be described later. It is desirable to reduce the impact when it hits the bottom portion 11b. In this case, the size of the airspace portion 13 is preferably 3.0 to 10.0 mm, which is larger than the upper diameter of the medicine to be stored, such as the vial lid 30a. Further, the means for forming the airspace portion 13 is not particularly limited, such as the intervention of a spacer, but it is convenient to appropriately provide a recess on the lower surface portion of the radiation shielding material 12.
As the material of the bottomed tubular body 11, plastics such as polypropylene and polyethylene are preferable, and as the material of the radiation shielding material 12, lead and tungsten are preferable.

１４は円板状の閉止部材で、有底筒状体１１の開口部１１ａを着脱自在に閉止すると共に、放射線遮蔽材１２を上方から圧接固定している。この閉止部材１４により、放射線遮蔽材１２の外方への飛び出しが防止される。また、この閉止部材１４を、不透明体とすることにより、放射線遮蔽材１２が外部から見えることを防止し得るので、きれいな外観の蓋体１０を提供することができる。この閉止部材１４の着脱方式は特に限定されないが、有底筒状体１１の開口部１１ａへの落し蓋的な内挿嵌合方式が簡便である。この場合、閉止部材１４の端縁部に着脱操作用のつまみ突片１４ａを付設するのが好ましい。
尚、閉止部材１４の材質としては、ポリプロピレンやポリエチレン等のプラスチックが好ましいものとして挙げられる。 Reference numeral 14 denotes a disk-shaped closing member, which detachably closes the opening 11a of the bottomed tubular body 11 and presses and fixes the radiation shielding material 12 from above. The closing member 14 prevents the radiation shielding material 12 from jumping out. Further, by making the closing member 14 an opaque body, it is possible to prevent the radiation shielding material 12 from being seen from the outside, so that it is possible to provide a lid 10 having a clean appearance. The method of attaching / detaching the closing member 14 is not particularly limited, but a method of inserting and fitting the bottomed tubular body 11 into the opening 11a is convenient. In this case, it is preferable to attach the knob protrusion piece 14a for the attachment / detachment operation to the end edge portion of the closing member 14.
As the material of the closing member 14, plastics such as polypropylene and polyethylene are preferable.

１５はキャップ部で、円板状本体部１５ａとその外周部下方に突出連成された周壁部１５ｂとから構成され、当該周壁部１５ｂが、閉止部材１４の上部に突出している有底筒状体１１の開口部１１ａ側壁に着脱自在に取り付けられている。このキャップ部１５の取り付けにより、閉止部材１４とキャップ部１５の間に添付文書１７等収納用の空域部１６が形成されると共に、放射線遮蔽材１２の外方への飛び出し防止が、閉止部材１４と相俟って強化される。この放射線遮蔽材１２の外方飛び出しをより確実にするために、当該周壁部１５ｂの当該開口部１１ａへの着脱自在の取り付けは螺合とするのが望ましい。また、この螺合での取り付けと合わせてあるいは別に、放射線遮蔽材１２の外方飛び出しをより確実にするために、閉止部材１４の上面部に、図２及び図３で示したように、キャップ部１５下面部に当接する突起１４ｂを適宜数配設するのも望ましい。キャップ部１５下面部に突起１４ｂが当接することで、実質的に閉止部材１４とキャップ部１５が一体となり、閉止部材１４の有底筒状体１１の開口部１１ａへの取り付けと当該周壁部１５ｂの当該開口部１１ａへの取り付けの２つの取り付け機構により放射線遮蔽材１２を圧接固定するからである。この場合、当該突起１４ｂの高さ（換言すれば空域部１６の上下間隔）は、５．０～１０．０ｍｍとするのが好ましい。
尚、キャップ部１５の材質としては、ポリプロピレンやポリエチレン等のプラスチックが好ましいものとして挙げられるが、特に透明材質のものを用いれば、空域部１６内の添付文書の有無を外部からチェックできるのでより望ましい。 Reference numeral 15 is a cap portion, which is composed of a disk-shaped main body portion 15a and a peripheral wall portion 15b protruding below the outer peripheral portion thereof, and the peripheral wall portion 15b has a bottomed tubular shape protruding above the closing member 14. It is detachably attached to the side wall of the opening 11a of the body 11. By attaching the cap portion 15, an airspace portion 16 for storing the package insert 17 and the like is formed between the closing member 14 and the cap portion 15, and the closing member 14 prevents the radiation shielding material 12 from jumping out. It will be strengthened in combination with. In order to ensure that the radiation shielding material 12 protrudes outward, it is desirable that the peripheral wall portion 15b be detachably attached to the opening portion 11a by screwing. Further, together with or separately from this screwing attachment, in order to more reliably eject the radiation shielding material 12 to the outside, a cap is placed on the upper surface of the closing member 14, as shown in FIGS. 2 and 3. It is also desirable to appropriately arrange a number of protrusions 14b that come into contact with the lower surface portion of the portion 15. When the protrusion 14b abuts on the lower surface of the cap portion 15, the closing member 14 and the cap portion 15 are substantially integrated, and the closing member 14 is attached to the opening 11a of the bottomed tubular body 11 and the peripheral wall portion 15b. This is because the radiation shielding material 12 is pressure-welded and fixed by the two attachment mechanisms of attachment to the opening 11a. In this case, the height of the protrusion 14b (in other words, the vertical distance between the airspace portions 16) is preferably 5.0 to 10.0 mm.
As the material of the cap portion 15, plastics such as polypropylene and polyethylene are preferable, but it is more preferable to use a transparent material because the presence or absence of the package insert in the airspace portion 16 can be checked from the outside. ..

２０は放射線遮蔽容器本体で、有底筒状体２１の内部に放射線遮蔽材２２が収納されている。この放射線遮蔽材２２にはバイアル３０等の医薬品収納用凹所２３が形成されていると共に、当該医薬品収納用凹所２３の略上半分の内壁部には、バイアル３０等の医薬品を保持固定するプラスチック製の内装材２４が挿置されている。
当該有底筒状体２１の側面部には、本発明遮蔽容器をシュリンク包装した場合に、フィルムの回り動きを防止するために、図１及び図４に示すような突状部２１ａを形成するのが好ましい。
尚、当該有底筒状体２１と放射線遮蔽材２２の材質は、それぞれ蓋体１０の有底筒状体１１並びに放射線遮蔽材１２と同様な材質が使用される。 Reference numeral 20 is a radiation shielding container main body, and the radiation shielding material 22 is housed inside the bottomed tubular body 21. A drug storage recess 23 such as a vial 30 is formed in the radiation shielding material 22, and a drug such as a vial 30 is held and fixed on the inner wall of substantially the upper half of the drug storage recess 23. A plastic interior material 24 is inserted.
A protruding portion 21a as shown in FIGS. 1 and 4 is formed on the side surface portion of the bottomed tubular body 21 in order to prevent the film from rotating when the shielding container of the present invention is shrink-wrapped. Is preferable.
As the material of the bottomed tubular body 21 and the radiation shielding material 22, the same materials as those of the bottomed tubular body 11 of the lid 10 and the radiation shielding material 12 are used, respectively.

当該放射線遮蔽容器本体２０の上部開口部に、上記の放射線遮蔽蓋体１０が、その有底筒状体１１の底部１１ｂ側において着脱自在に取り付けられている。この蓋体１０の容器本体２０への着脱自在の取り付けは、収納された放射性医薬品の飛び出しを防止するために螺合方式が望ましい。この場合、蓋体１０の有底筒状体１１の外周壁を底部１１ｂより下方に延設し、当該延設外周壁内側と容器本体２０の上部外周壁外側において螺合せしめるのが簡便である。 The radiation shielding lid 10 is detachably attached to the upper opening of the radiation shielding container main body 20 on the bottom portion 11b side of the bottomed tubular body 11. The detachable attachment of the lid 10 to the container body 20 is preferably a screwing method in order to prevent the stored radiopharmaceutical from popping out. In this case, it is convenient to extend the outer peripheral wall of the bottomed tubular body 11 of the lid 10 below the bottom portion 11b and screw the inside of the extended outer peripheral wall and the outer side of the upper outer peripheral wall of the container body 20. ..

１０：放射線遮蔽蓋体
１１：有底筒状体
１１ａ：開口部
１１ｂ：底部
１１ｃ：環状凹所
１２：放射線遮蔽材
１２ａ：筒状突出部
１２ｂ：テーパー内面
１３：空域部
１４：閉止部材
１４ａ：つまみ突片
１４ｂ：突起
１５：キャップ部
１５ａ：円板状本体部
１５ｂ：周壁部
１６：空域部
１７：添付文書
２０：放射線遮蔽容器本体
２１：有底筒状体
２１ａ：突状部
２２：放射線遮蔽材
２３：医薬品収納用凹所
２４：内装材
３０：バイアル
３０ａ：バイアル蓋 10: Radiation shielding lid 11: Bottomed tubular body 11a: Opening 11b: Bottom 11c: Circular recess 12: Radiation shielding material 12a: Cylindrical protrusion 12b: Tapered inner surface 13: Airspace 14: Closing member 14a: Knob projectile 14b: Projection 15: Cap 15a: Disc-shaped body 15b: Peripheral wall 16: Airspace 17: Attachment 20: Radiation shielding container body 21: Bottomed tubular body 21a: Projection 22: Radiation Shielding material 23: Drug storage recess 24: Interior material 30: Vial 30a: Vial lid

Claims

The radiation shielding material is housed in the bottomed tubular body, and the opening of the bottomed tubular body is detachably closed by a closing member, so that the radiation shielding lid body emits radiation on the bottom side of the bottomed tubular body. Shielding container A shielding container for radiopharmaceuticals, which is characterized by being detachably attached to the main body.

The radiation shielding material is stored in the bottomed tubular body by inserting and fitting the protrusion formed at the lower part of the radiation shielding material into the recess formed at the bottom of the bottomed tubular body. The shielding container for radiopharmaceuticals according to claim 1, which is characterized.

The protrusion is a tubular protrusion having a tapered inner surface that slopes downward from the inside to the outside on the lower outer edge of the radiation shielding material, and the recess is on the bottom outer edge of the bottomed tubular body. The shielding container for radiopharmaceuticals according to claim 2, wherein the annular recess has a taper corresponding to the outer shape of the tubular protrusion.

The shielding container for radiopharmaceuticals according to claim 3, wherein the downward inclination angle of the inner surface of the taper is 100 ° to 135 ° with respect to the lower surface of the radiation shielding material.

The radiopharmaceutical product according to any one of claims 1 to 4, wherein the radiation shielding material is stored with a first airspace portion provided between the radiation shielding material and the bottom of the bottomed tubular body. Shielding container.

The shielding container for radiopharmaceuticals according to claim 5, wherein the first airspace portion is provided by forming a recess on the lower surface portion of the radiation shielding material.

The radiopharmaceutical according to any one of claims 1 to 6, wherein the bottomed tubular body is provided with a removable cap portion that forms a second airspace portion on the upper portion of the closing member. For shielding container.

The shielding container for radiopharmaceuticals according to claim 7, wherein the closing member includes a protrusion that abuts on the lower surface portion of the cap portion.

The radiopharmaceutical according to any one of claims 1 to 8, wherein the main body of the radiopharmaceutical container is a bottomed tubular body in which a radiopharmaceutical material having a recess for storing the radiopharmaceutical is formed. Shielding container for.