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通过各种放射性药物参数测量不同制造商的99锝骨扫描制剂的体外稳定性。

In vitro stability of 99Tcm bone scan preparations from different manufacturers measured by various radiopharmaceutical parameters.

作者信息

Pauwels E K, Feitsma R I

出版信息

Nucl Med Commun. 1984 Jul;5(7):467-72.

PMID:6099535
Abstract

We have investigated the stability of 99Tcm-labelled kit preparations of the bone seeking agents methylene diphosphonate (MDP), hydroxymethylene diphosphonate (HDP) and dicarboxypropane diphosphonate (DPD). This was done by determining amounts of free 99Tcm pertechnetate under various experimental parameters. The radiopharmaceuticals were made with 100 and 300 mCi 99Tcm eluents and kept under the moderate condition of occasional inverting (1) or continuous rolling (2). Analysis took place 5 min, 2 h, 4 h and 6 h after preparation. In general free 99Tcm pertechnetate concentrations were less when 100 mCi 99Tcm eluent was used than with 300 mCi amounts. The level of impurity was also lower in vials kept under condition (1) than in vials kept under condition (2). Unexpected concentrations of free 99Tcm pertechnetate (maximum about 30%) were found in some commercial preparations. Only in one MDP and one HDP preparation did the average free 99Tcm pertechnetate concentration stay within tolerable limits under all experimental parameters. This study demonstrates that careful quality control is needed and that only freshly prepared bone-seeking radiopharmaceuticals should be applied, especially when 99Tcm eluents of about 300 mCi are used for kit preparation.

摘要

我们研究了99锝标记的亲骨剂亚甲基二膦酸盐(MDP)、羟亚甲基二膦酸盐(HDP)和二羧基丙烷二膦酸盐(DPD)试剂盒制剂的稳定性。通过在各种实验参数下测定游离高锝酸盐99锝的量来进行此项研究。放射性药物用100和300毫居里的99锝洗脱液制备,并在偶尔倒置(1)或连续滚动(2)的适度条件下保存。在制备后5分钟、2小时、4小时和6小时进行分析。一般来说,使用100毫居里99锝洗脱液时的游离高锝酸盐99锝浓度低于使用300毫居里时的浓度。在条件(1)下保存的小瓶中的杂质水平也低于在条件(2)下保存的小瓶。在一些商业制剂中发现了意外浓度的游离高锝酸盐99锝(最高约30%)。只有一种MDP制剂和一种HDP制剂在所有实验参数下的平均游离高锝酸盐99锝浓度保持在可接受范围内。本研究表明需要仔细的质量控制,并且仅应使用新制备的亲骨放射性药物,尤其是当约300毫居里的99锝洗脱液用于试剂盒制备时。

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