新型心肌灌注显像剂~(99)Tc~mN-MIBI的药盒研制及质量控制

目的　建立心肌灌注显像剂99TcmN 甲氧基异丁基异腈 (MIBI)的药盒法制备及其质量控制方法。方法　由条件实验确定药盒中各组分的最佳含量。参照《中国药典》(1995年版 )方法进行澄清度、pH值、无菌以及急性毒性检查。将药盒置于不同环境下存放不同时间 ,通过外观、主药含量及配合物标记率的变化来检查药盒的稳定性。结果　药盒的澄清度、pH值、无菌以及急性毒性检查合格 ,稳定性好。药盒法制备的配合物标记率大于 95 %。结论　药盒法制备99TcmN MIBI配合物简便易行 ,符合临床试用要求。

The development and quality control of a kit for the preparation of a new myocardial perfusion imaging agent, ~(99)Tc~mN-MIBI

Objective To develop a kit for the preparation of a new myocardial perfusion imaging agent, 99 Tc mN MIBI, and to create the criteria of quality control for the kit. Methods The optimal content of the bases were determined by the condition experiments. The methods for testing transparence,pH, asepsis and toxicity were referred to the CHINA PHARMACOPOEIA (edited in 1995). The stability of the kit was estimated by the appearance, the content of the bases and the labelling yield of the complex under different conditions at different times. Results The test results of the transparence, pH, asepsis and toxicity demonstrated the characterastics of the kit were up to the standard and the stability of the kit was good. The labelling yield of the complex 99 Tc mN MIBI prepared by the kit was more than 95%. Conclusions The preparation of 99 Tc mN MIBI with the kit is reliable, practical and easy to perform with excellent quality control. The complex is qualified for clinical use.