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使用SHIs HM-18回旋加速器和专用模块全自动合成氮-13-NH₃用于常规临床研究:我们机构的经验。

Fully Automated Synthesis of Nitrogen-13-NH3 by SHIs HM-18 Cyclotron and Dedicated Module for Routine Clinical Studies: Our Institutional Experiences.

作者信息

Akhilesh Singh K, Shanker Nilesh, Subhash Kheruka C, Sanjay Gambhir, Dixit Manish

机构信息

Department of Nuclear Medicine, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India.

出版信息

Indian J Nucl Med. 2022 Jan-Mar;37(1):50-53. doi: 10.4103/ijnm.ijnm_92_21. Epub 2022 Mar 25.

Abstract

AIMS

The production of nitrogen-13 (N)-NH by ethanol method using automated synthesizer and accessing the production yield, quality control for clinical application.

CONTEXT

N, together with F, O, and C, is one of the positron emitters that can be produced on the multi-gigabecquerel scale in biomedical cyclotrons. (N)-ammonia is frequently used for cardiac PET studies. It is widely applied for the evaluation of myocardial perfusion in the clinical assessment of cardiac disorders. Simple, fast, and reliable preparation methods have contributed to the routine application of this tracer. Although only two methods are available, a challenge remains to adopt a more efficient and consistent approach to its production. For clinical application, routine production of this tracer is mandatory in compliance with regulatory guidelines. Being at hospital radiopharmacy it is our responsibility to support the clinical service with uninterrupted production and supply of (N)-NH.

MATERIALS AND METHODS

The chemicals were used commercially available from Sigma Aldrich, India, Ltd., and Fisher Scientific, India, Ltd. (Mumbai, India), Sep-Pak CM cartridges (Waters India, Pvt., Ltd.,). Radio-thin layer chromatography was carried out using aluminum sheets precoated with silica gel 60 F254 (E. Merck, India).

RESULTS

The protocol developed with MPS-100 synthesizer yield (N)-NH95-97% (EOB) with a synthesis time of around 7 min.

CONCLUSIONS

With the installation of HM-18 cyclotron at our hospital, center is capable to produce (N)-NH of good yield and purity through the ethanol method, for mycocardial perfusion studies. Our protocol is simple, reproducible, and robust.

摘要

目的

使用自动合成仪通过乙醇法生产氮-13(N)-氨,并评估其产量以及进行临床应用的质量控制。

背景

N与F、O和C一样,是可在生物医学回旋加速器上以多吉贝可勒尔规模生产的正电子发射体之一。(N)-氨常用于心脏PET研究。它在心脏疾病的临床评估中广泛应用于心肌灌注的评估。简单、快速且可靠的制备方法推动了这种示踪剂的常规应用。尽管仅有两种方法可用,但采用更高效且一致的生产方法仍面临挑战。对于临床应用,必须按照监管指南常规生产这种示踪剂。作为医院放射性药房,我们有责任通过不间断地生产和供应(N)-氨来支持临床服务。

材料与方法

所用化学试剂购自印度西格玛奥德里奇有限公司和印度费希尔科学有限公司(印度孟买),Sep-Pak CM柱(印度沃特世私人有限公司)。使用预涂有硅胶60 F254的铝板(印度默克公司)进行放射性薄层色谱分析。

结果

用MPS - 100合成仪开发的方案以95 - 97%(放化产率)的产率生成(N)-氨,合成时间约为7分钟。

结论

随着我院安装了HM - 18回旋加速器,中心能够通过乙醇法生产出高产率和高纯度的(N)-氨,用于心肌灌注研究。我们的方案简单、可重复且稳定可靠。

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