论文部分内容阅读
为获得高质量的心肌灌注显像剂，作者进行了99mTc－N，N＇-亚乙基-二（乙酰丙配亚胺）二（三（3-甲氧基-1-丙基）膦］（99mTc－Q3）的制备方法学研究。采用多元正变试验法进行了制备99mTc－Q3最佳配方的筛选；用氯化亚锡化学还原法制备99mTc－Q3；用柱沉析法进行99mTc－Q3的分离和纯化、质量控制及体外稳定性试验；完成了无菌、热原、安全试验及家免显像验证。制备99mTc－Q3的最佳配方为“A2B2C2”（即：氢氧化钾、Sn2+及配体分别处于二水平的结果）。药物标记率和放化纯大于99％。药物体外稳定性好，标记后4小时测得其标记率仍然大于92％（92％～99．37％）。兔显像发现：注射99mTc－Q3后5分钟心肌便显影，至3小时心肌影像仍清晰可见。注射1小时后，血、肺中的放射性接近本底、提示：该方法可获得高质量的99mTc－Q3，而且为所有99mTc-显像剂的制备建立了标准化流程，在此基础上可进一步研制99mTc－Q3的一步法药盒。
To obtain high-quality myocardial perfusion imaging agents, the authors performed 99mTc-N, N’-ethylene-bis (acetylacrindimide) bis (tris (3- methoxy- 1 -propyl) phosphine] (99mTc-Q3) preparation method.Multiple positive change test was used to prepare 99mTc-Q3optimum formula.It was used to prepare 99mTc-Q3 by stannous chloride chemical reduction method.The 99mTc- Q3 was isolated and purified, and its quality control and in vitro stability test were completed.The sterility, pyrogenation, safety test and home-free imaging were completed.The optimum formula for preparing 99mTc-Q3 was “A2B2C2” (ie potassium hydroxide, Sn2 + and ligand were at two levels respectively.) The drug labeling rate and radiochemical purity were more than 99% .The drug was stable in vitro with the labeling rate still greater than 92% (92% -99.37% ) .Immunography showed that 5 minutes after injection of 99mTc-Q3 myocardial imaging was developed, 3 hours myocardial imaging was still clearly visible.After 1 hour of injection, blood, lung radioactivity near the background, suggesting that: This method can obtain high quality Of 99mTc-Q3, but also for the preparation of all 99mTc-imaging agents Standardized processes, based on this research one step further kit of 99mTc-Q3.