Patel M, Owunwanne A, Tuli M, al-Za'abi K, al-Mohannadi S, Sa'ad M, Jahan S, Jacob A, al-Bunny A
Department of Nuclear Medicine, Kuwait Cancer Control Center, Kuwait City.
J Nucl Med Technol. 1998 Dec;26(4):269-73.
The objectives of this study were to: modify the preparation of 99mTc-tetrofosmin by using twice the amount of 99mTcO4- recommended by the manufacturer; evaluate the use of miniaturized rapid paper chromatography (MRPC) for quality control (QC) testing; and determine the in vitro stability of the modified preparation using MRPC.
Two preparations of 99mTc-tetrofosmin were made: one with 4.4-8.8 GBq (120-240 mCi) and the other with 13.9-17.6 GBq (380-480 mCi) 99mTcO4-, referred to as regular and modified preparations, respectively. Routine QC tests were performed using MRPC and instant thin-layer chromatography/silica-gel (ITLC/SG) systems. The preparations were injected into 58 patients. Planar and SPECT images of stress and rest studies were obtained. The technical quality of the SPECT images was graded visually by four observers. Heart-to-lung and heart-to-background ratios were calculated from the planar images.
The QC testing procedure took 4.18 +/- 0.15 min with MRPC and 54 +/- 5.3 min with ITLC/SG systems. The percent labeling efficiency, as determined by both techniques, ranged from 95.6 +/- 1.6 to 97.2% +/- 0.8%. Both preparations were stable up to 6 hr after reconstitution. There was no difference between the cardiac-to-lung and cardiac-to-background ratios of the two preparations.
The results indicate that MRPC is a faster and effective chromatographic technique for routine QC testing of 99mTc-tetrofosmin. Doubling the amount of 99mTcO4- used in preparing 99mTc-tetrofosmin did not affect its in vitro stability, its efficacious use in patients or the technical quality of the images.
本研究的目的是:通过使用制造商推荐量两倍的99mTcO4-来改进99mTc-替曲膦的制备方法;评估小型快速纸色谱法(MRPC)用于质量控制(QC)测试的情况;并使用MRPC确定改进后制剂的体外稳定性。
制备了两种99mTc-替曲膦制剂:一种使用4.4 - 8.8 GBq(120 - 240 mCi)的99mTcO4-,另一种使用13.9 - 17.6 GBq(380 - 480 mCi)的99mTcO4-,分别称为常规制剂和改进制剂。使用MRPC和即时薄层色谱/硅胶(ITLC/SG)系统进行常规QC测试。将制剂注射给58名患者。获得了负荷和静息研究的平面和SPECT图像。由四名观察者对SPECT图像的技术质量进行视觉分级。从平面图像计算心-肺和心-本底比值。
MRPC进行QC测试的程序耗时4.18±0.15分钟,而ITLC/SG系统耗时54±5.3分钟。两种技术测定的标记效率百分比范围为95.6±1.6%至97.2%±0.8%。两种制剂在复溶后长达6小时均稳定。两种制剂的心-肺和心-本底比值之间没有差异。
结果表明,MRPC是用于99mTc-替曲膦常规QC测试的一种更快且有效的色谱技术。制备99mTc-替曲膦时将99mTcO4-的用量加倍不会影响其体外稳定性、在患者中的有效使用或图像的技术质量。