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Annals of Nuclear Medicine and Molecular Imaging

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篇名 核醫腦部灌注顯影劑ECD套組分裝之研究及其經濟效益
卷期 16:4
並列篇名 Fractionation of ECD Kit
作者 林漢民陳藝文劉仁賢
頁次 191-196
關鍵字 鎝 99m ECD分裝節省成本[fee6]Tc ECDFractionationCost reduction
出刊日期 200312

中文摘要

背景: 鎝-99m ECD是一種核醫腦部放射性影劑,是由ECD與鎝-99m結合而成的錯合物。而ECD套組價位非常昂貴,需約12,000元,此研究目的是嫄原廠ECD套組分裝成若千份,並以原方法標籤(Labeling)北分裝完成之套組,冀以降低用藥成本。
方法: 首先加入3ml生理食鹽注射液溶解產廠ECD套組中A瓶之冷凍結晶物,使該溶液分成三等份(稀釋比例3:1),並冷凍於-80°C冰箱中三個月。套組中緩衝液B瓶,則按仿單說明自行採購及配製成新無菌磷酸鹽緩衝液。
結果: 按原廠方法,以100毫居里(mCi)過鎝酸鈉(Na99mTcO4)標幟含原廠1/3含量之ECD冷凍液,經90天後取出標幟後第6小時放射化學純度(Radiochemical purity)為95.4±1.8% (n=28),均符國藥典規定。
結論: 將原廠藥量分裝成三等份再行使用是可行的。ECD套組,經分裝及扣除耗材等成本後,成本仍可降低至只有原價格的33%之多。

英文摘要

Backgrounds: 99mTc-ECD is a useful diagnostic tracer of central nervous system disorder, and is a complex of 99mTc and ECD. ECD kit is very expensive, about NT$ 12,000 per kit. The aim of the study is to divide the ECD kit into three fractions to reduce cost.
Methods; By dissolving the lyophilized ingredients of vial A of ECD kit with 3mL normal saline, the resultant liquid is divided into 1 ml aliquot vials are than frozen at -80°C for three months. Vial B (buffer solution) of ECD kit is prepared by ourselves according to the package insert of ECD kit.
Results: After 90 days, the average radiochemical purity of the 3:1 dilution ECD after reconstitution with 100 mCi 99mTc was maintained at 95.4±1.8% (n=28) for 6 h. The quality meets the requirements of USP.
Conclusion: The fractionation of ECD kits and keeping in frozen temperature maintains the stability of the ECD, and gets cost reduction of ECD kit using.

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