锝-99m-巯基乙酰三甘氨酸肝胆排泄及影响放射化学纯度的复溶因素评估。

Evaluation of the hepatobiliary excretion of technetium-99m-MAG3 and reconstitution factors affecting radiochemical purity.

作者信息

Shattuck L A, Eshima D, Taylor A T, Anderson T L, Graham D L, Latino F A, Payne S E

机构信息

Department of Radiology, Emory University Hospital, Atlanta, Georgia 30322.

出版信息

J Nucl Med. 1994 Feb;35(2):349-55.

PMID:8295009

Abstract

UNLABELLED

Technetium-99-MAG3 is a renal tubular function agent. However, sporadic liver and gallbladder visualization have raised questions about kit stability, impurities and nonrenal routes of excretion. To address these issues, studies were conducted to optimize the labeling efficiency of the TechneScan MAG3 kit and to evaluate the hepatobiliary excretion of the MAG3 complex.

METHODS

Thirty-six vials of the commercial formulation of 99mTc-MAG3 were prepared according to manufacturer's instructions and evaluated for radiochemical purity using two methods: a combination of high-performance liquid chromatography and paper chromatography (HPLC/PC); and the manufacturer's miniature chromatography system (Sep-Pak procedure).

RESULTS

The labeling efficiency was significantly higher when the kit was reconstituted with 10 ml (96.6%) of saline versus 5 ml (91.4%) (p < 0.01). The radiochemical purity of the kits remained stable for up to 6 hr, but the purity determined by Sep-Pak averaged 2.5% higher than that determined by HPLC procedures (p < 0.01). Rat studies to evaluate renal and hepatobiliary elimination of MAG3 showed no difference in the %ID excreted into the urine by 60 min in all groups of animals studied. However, the %ID excreted into the bile was significantly higher for the kit formulation than the HPLC-purified MAG3, 9.9% versus 6.6% (p = 0.0475).

CONCLUSION

The radiochemical purity of the TechneScan MAG3 kit can be improved by reconstituting with larger volumes. In addition, the studies in rats suggest that fasting or kit impurities may be a contributing factor to increased hepatobiliary visualization in patient studies.

摘要

未标记

锝-99-巯基乙酰三甘氨酸（Technetium-99-MAG3）是一种肾小管功能显像剂。然而，偶尔出现的肝脏和胆囊显影引发了关于试剂盒稳定性、杂质以及非肾排泄途径的疑问。为解决这些问题，开展了多项研究以优化Technescan MAG3试剂盒的标记效率，并评估MAG3复合物的肝胆排泄情况。

方法

按照制造商说明制备36瓶商用99mTc-MAG3制剂，并使用两种方法评估其放射化学纯度：高效液相色谱法与纸色谱法相结合（HPLC/PC）；以及制造商的微型色谱系统（Sep-Pak法）。

结果

用10 ml生理盐水复溶试剂盒时标记效率显著更高（96.6%），而用5 ml生理盐水时为91.4%（p < 0.01）。试剂盒的放射化学纯度在长达6小时内保持稳定，但Sep-Pak法测定的纯度平均比HPLC法高2.5%（p < 0.01）。评估MAG3肾排泄和肝胆排泄的大鼠研究表明，在所有研究的动物组中，60分钟时尿中排泄的注入剂量百分比（%ID）无差异。然而，试剂盒制剂胆汁中排泄的%ID显著高于HPLC纯化的MAG3，分别为9.9%和6.6%（p = 0.0475）。