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单元操作方法应用于[1(-11)C]2-脱氧-D-葡萄糖的合成以用于常规临床应用。

The unit operations approach applied to the synthesis of [1(-11)C]2-deoxy-D-glucose for routine clinical applications.

作者信息

Padgett H C, Barrio J R, MacDonald N S, Phelps M E

出版信息

J Nucl Med. 1982 Aug;23(8):739-44.

PMID:7108617
Abstract

An approach to the design of remote semiautomated chemical processing systems has been developed and tested in more than 750 production runs. This design stresses the idea of unit operations, which allows maximum flexibility while maintaining the highest possible standards regarding safety, reliability, efficiency, and practicality. Application of this approach has resulted in the development of a simple and reliable remote semiautomated synthesis system for the routine production of [1(-11)C]2-deoxy-D-glucose. Use of this system results in the preparation of a sterile, pyrogen-free product suitable for human injection after a synthesis time of 50 min, with radiochemical purity of greater than 98% and yields (25-30%) permitting quantitative measurements using positron computed tomography.

摘要

一种远程半自动化学处理系统的设计方法已经被开发出来,并在超过750次生产运行中进行了测试。这种设计强调单元操作的理念,它在保持尽可能高的安全、可靠性、效率和实用性标准的同时,允许最大程度的灵活性。这种方法的应用导致开发出一种简单可靠的远程半自动合成系统,用于常规生产[1(-11)C]2-脱氧-D-葡萄糖。使用该系统,在50分钟的合成时间后,可制备出适合人体注射的无菌、无热原产品,其放射化学纯度大于98%,产率(25-30%)允许使用正电子计算机断层扫描进行定量测量。

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